Publichealth.uconn.edu

Review and Evaluation of
Proposed Health Benefit Mandates
The Center for Public Health and Health Policy, a research and programmatic center founded in 2004, integrates public health knowledge across the University of Connecticut campuses and leads initiatives in public health research, health policy research, health data analysis, health information technology, community engagement, service learning, and selected referral services. March 2011, University of Connecticut Pursuant to Public Act 09-179, the Chairs of the Insurance and Real Estate Committee of the Connecticut General Assembly (the Committee) directed the Connecticut Insurance Department to review five proposed health benefits in a letter dated July 22, 2010. The proposed health benefits listed in the letter to be reviewed include: An increase in coverage for prescription eye drops (as described in SB 92, File 24, from the 2010 General Assembly session); An increase in coverage for magnetic resonance imaging (MRI) (as described in SB 259, File 89, from the 2010 General Assembly session); An increase in coverage for Parkinson's disease and multiple sclerosis (MS) in clinical trials (as described in SB 260, File 247, of the 2010 General Assembly Session); An expansion of coverage for neuropathic disorders associated with diabetes (later withdrawn); and An expansion of coverage for gastric bypass surgery.
This review has been performed in accordance with that request and with follow-up communication with the Committee. Reviews of proposed health benefits are collaborative efforts of the Connecticut Insurance Department and the University of Connecticut Center for Public Health and Health Policy, with the assistance of Ingenix Consulting. With the exception of an expansion of coverage for neuropathic disorders associated with diabetes, each proposed health benefit was studied separately and the key findings of these studies are reported below. At a date following receipt of the original letter, the Committee and the Connecticut Insurance Department agreed to forgo analysis of the proposed health benefit for neuropathic disorders associated with diabetes until further information related to the specific service(s) to be analyzed is available.
Brief summary of the proposed health benefits
Prescription eye drops: As defined by the bill, the proposed health benefit would provide an extra bottle of
eye drops for children for use at their school or day care provider and an extra refill for children and adults
who run out eye drops before the end of the month.
MRI for breast cancer screening: As defined by the bill, the proposed health benefit would require insurers
to cover magnetic resonance imaging (MRI) for breast cancer screening if a mammogram shows dense breast
tissue or for women who are considered at an increased breast cancer risk due to a variety of circumstances.
Routine patient care costs of clinical trials and off-label drug prescriptions for Parkinson's disease and multiple sclerosis: As defined by the bill, the proposed health benefit would require insurers to cover routine patient care costs for persons enrolled in clinical trials for Parkinson's disease and multiple sclerosis. The bill also requires plans that cover prescription drugs to cover prescriptions of drugs that have been FDA-approved for treatment of Parkinson's disease if prescribed for treatment of multiple sclerosis and to cover prescriptions that have been FDA-approved for treatment of multiple sclerosis if prescribed for treatment of Parkinson's disease.
Gastric bypass surgery: No associated bill is referenced in the letter received from the Committee. Gastric
bypass surgery is a type of bariatric surgery. Bariatric surgery is a term used for several surgical procedures
for the treatment of obesity.
Estimated cost of proposed health benefits
The estimated costs shown below are based on an actuarial analysis of a sample of national claims data for group plans. The 2011 estimated medical cost in group plans of the four proposed health benefits combined is estimated to be $1.49 per member per month (PMPM). The vast majority of the incremental expense is medical cost. The medical cost of each proposed health benefit is shown below. Per Member Per Month
Prescription Eye Drops MRI Screening for Breast Cancer Cancer Clinical Trials Total Medical Costs Administrative Cost and Risk/Profit Charges Total Estimated 2011 Cost in Group Plans
Note: Due to lack of data, estimated costs for individual health insurance policies and in self-funded plans in
Connecticut is not available.
Existing health insurance coverage for the proposed health benefits
Seven health insurers and managed care organizations (MCOs) domiciled in Connecticut were surveyed regarding existing insurance coverage for the proposed health benefits in their fully insured group plans, individual policies, and self-funded plans for which they administer benefits. Four insurers/MCOs provided some information about current coverage. For the four insurers/MCOs that provided information: Percent of group plans with coverage
Prescription Eye Drops Percent of individual plans with coverage
Prescription Eye Drops Percent of self-funded plans with coverage
Prescription eye drops Financial burden on insureds
Prescription eye drops: The economic analysis states that the proposed health benefit, if enacted, would
relieve a relatively small financial burden related to coverage for children and potential relief from large
financial burdens for adults because typically adult eye diseases are more expensive to treat and require longer
term treatment than children's eye diseases in general.
MRI for breast cancer screening: The economic analysis states that in general, studies have shown breast
cancer screening to be cost effective thereby saving the affected families as well as the insurers and the health
care system significant expenses for cancer treatment down the road. The cost of treatment for breast cancer
varies, among other things, by the type of treatment and services provided, by cancer stage and by the age at
diagnosis. If the proposed health benefit results in earlier detection of breast cancer, the financial impact on
insureds may be reduced.
Routine patient care costs of clinical trials and off-label drug prescriptions for Parkinson's disease and
multiple sclerosis: Insurers and MCOs in Connecticut report that routine patient care costs associated with
clinical trials are covered in general, thus no financial burden on insureds would be expected to be relieved
as a result of the proposed health benefit. Because most insurers report that they allow off- label medication
use, the cost impact for patients under this mandate would represent their cost-sharing for the off-label drug
use. This cost burden impacts all income levels, except for those with extremely high incomes, albeit in
different ways. A lower income family may simply have to forego the treatment in the absence of this the
proposed health benefit, whereas a higher income family may have to choose between foregoing the therapy
and assuming substantial financial burden.
Gastric bypass surgery: Gastric bypass surgery is a high-cost medical procedure, thus requiring insurance
coverage for appropriate populations is likely to decrease financial burden for those who undergo the
procedure. Financial burden may be significant even for those with insurance coverage depending on the
cost sharing requirements of the health plan or policy.
Impact of proposed health benefit on use of procedure, service or equipment
Prescription eye drops: The actuarial reports estimates a utilization increase of ten percent in 2011 and an
expected increase over the next several years.
MRI for breast cancer screening: The actuarial report states that utilization of MRI in general has increased
over the past ten years, which suggests that the proposed health benefit could contribute to continued
increase in utilization. Additionally, the utilization of MRI for breast cancer screening in Connecticut is
already two to three times the level of the rest of the nation. The actuarial report estimates that the proposed
health benefit will double the use of MRI for breast cancer screening over the next five years.
Routine patient care costs of clinical trials and off-label drug prescriptions for Parkinson's disease and
multiple sclerosis: The proposed health benefit is not expected to significantly affect the enrollment in
Parkinson's disease and multiple sclerosis clinical trials, utilization of routine patient care costs associated
with such clinical trials, or off-label use of FDA-approved Parkinson's disease prescriptions for treatment of
multiple sclerosis and vice versa.
Gastric bypass surgery: The research on changes in utilization following the introduction of insurance
coverage for bariatric surgery suggests minimal changes in utilization.
Required Coverage in Other States
Prescription eye drops: No states require coverage of prescription eye drops as defined in the bill.
MRI for breast cancer screening: Forty-nine states and the District of Columbia require coverage of
screening mammograms. However, no states require coverage of screening MRIs.
Routine patient care costs of clinical trials and off-label drug prescriptions for Parkinson's disease and
multiple sclerosis: No states require coverage of routine patient care costs associated with clinical trials
specifically for Parkinson's disease or multiple sclerosis. Several states require coverage of routine patient
care costs associated with clinical trials with "life-threatening conditions", which it is assumed would include
Parkinson's disease and multiple sclerosis. No other states require coverage specifically for off-label use of
FDA-approved prescriptions for multiple sclerosis for the treatment of Parkinson's disease or vice versa.
Gastric bypass surgery: The National Association of Insurance Commissioners identified Maryland, New
Hampshire, Indiana, and Virginia as states with mandates either requiring inclusion of coverage or offers of
coverage for the surgical treatment of morbid obesity.
Table of Contents
Executive Summary .i
General Overview .1
Figure 1. Health Insurance Coverage of the Connecticut Population, 2008 .2 Figure 2. Types of Health Plans, Connecticut Insurers .3 Chapter 1. Prescription Eye Drops .5
Overview .7
Background .8
Methods .14
Social
Chapter 2. An Increase in Coverage for Magnetic Resonance Imaging .23
Overview .25
Background .27
Methods .30
Social
Chapter 3. Parkinson's Disease and Multiple Sclerosis: Routine Patient Care Costs

for Clinical Trials and Off-Label Drug Prescriptions .37
Overview .39 Background .40 Methods .48 Social Chapter 4. Gastric Bypass .65
Overview .67
Background .68
Methods .76
Social
Appendix I. Letter from the Insurance and Real Estate Committee dated July 22, 2010 .97 Appendix II. Connecticut General Assembly Bills .99 Appendix III. Ingenix Consulting Actuarial Report .133 Appendix IV. Ingenix Consulting Financial and Socioeconomic Report .175 Appendix V. Glossary of Terms and Acronyms.195 Appendix VI. Work Group and Support Team .203 Appendix VII. Acknowledgements .205 Review and Evaluation of
Proposed Mandated Health Insurance Benefits in Connecticut
Over the last 60 years, the Connecticut General Assembly has enacted numerous health insurance benefit mandates and limitations on health insurers licensed to sell insurance in Connecticut. In keeping with a growing trend among the states, the General Assembly in 2009 directed the Connecticut Insurance Department (CID) to review and evaluate both proposed and existing mandates, as requested by the co-chairs of the Insurance and Real Estate Committee of the General Assembly (P.A. 09-179). This statute directed CID to contract with the University of Connecticut Center for Public Health and Health Policy (CPHHP) to perform such reviews, and authorized CID to recover the costs of such contract through assessments on the insurers. It also authorized the CPHHP to obtain whatever expertise it needed to perform the reviews, whether from inside or outside the university.
By letter dated July 22, 2010, the co-chairs of the Insurance and Real Estate Committee (Committee) requested CID to report on five proposed health insurance benefits by January 1, 2011. A copy of this letter is attached to this report as Appendix I. This deadline was later extended to March 1, 2011 by agreement between the CID and the co-chairs of the Committee.
Three of the proposed health benefits (dealing with coverage for breast magnetic resonance imaging, prescription eye drops and coverage for routine costs of clinical trials and off-label drugs for multiple sclerosis and Parkinson's disease) had been introduced in the legislature in prior sessions. The request from the co-chairs referenced these bills, and they form the basis of the analyses of these proposed health benefits contained in this report. One proposed health benefit (coverage for gastric bypass surgery) did not have a reference to prior legislation, but prior bills on bariatric surgery were deemed to be germane by CID and were used to inform the analysis of this proposed health benefit. Copies of these bills are attached to this report as Appendix II. The CID deemed the fifth proposed health benefit request to be too vague to permit meaningful analysis, and by agreement with the co-chairs of the Committee, it was dropped from the request. All of these proposed health benefits would apply to both individual and group health insurance policies sold, delivered or amended in Connecticut. This report is comprised of five parts: the general overview and four sections. Each section reviews one of the four proposed health benefits. Each of the four sections can stand on its own, since insurance benefit mandates generally are raised separately in individual proposed legislation. P.A. 09-179 details 25 issues to be addressed in the review of each proposed health benefit. These issues are divided into those which affect primarily the social impact of a health benefit and those which affect primarily the financial impact, although we found a good deal of overlap among the items in the two categories in the course of our research. Each section of this report addresses these issues for the respective proposed health benefit. In addition, each section contains a background section that describes the condition, services, equipment or supplies addressed by the proposed health benefit and the segment of the general population most affected by the condition, service, equipment or supplies.
Caveat: It is important to understand that states only have the power to mandate health insurance benefits
in fully-insured products, which are regulated by the states as the business of insurance. Health plans
provided by employers or organizations that do not purchase insurance policies to fund them are beyond
the reach of state regulation and are only subject to federal regulation, pursuant to the Employee Retirement
Income Security Act (so-called ERISA preemption). This is so even if the employer or group sponsor
contracts with an insurance company to provide "administrative services only", because the employer
retains the risk of funding the benefits itself and no insurance is involved. So-called ASO contracts are not
considered insurance policies and therefore are not subject to state insurance regulation. The Connecticut
Insurance Department has estimated that approximately 50 percent of Connecticut's workforce is covered
by fully insured health plans. Therefore, only 50 percent of employees in Connecticut will be covered by
any benefit mandated by statute, although it is not uncommon for some state mandated benefits to be
included in ASO plans. In addition, the Department has expressed a concern that the trend is for more and
more employers and organizations to opt for self-insured plans, even relatively medium or small employers.
Thus, state benefit mandates may be applicable to an ever shrinking number of employees. Figures 1 and
2 show the sources of health care coverage for Connecticut residents and the types of health plans in which
Connecticut residents are enrolled.
Figure 1. Health Insurance Coverage of the Connecticut Population, 2008
Source: State Health Facts, Kaiser Family Foundation. Av (Urban Institute and Kaiser Commission on Medicaid and the Uninsured estimates based on the Census Bureau's March 2008 and 2009 Current Population Survey (CPS: Annual Social and Economic Supplements)).
Proposed Health Benefits
Figure 2. Types of Health Plans,
The four proposed health benefits for which the Insurance Committee requested review are: An increase in coverage for prescription eye drops, as described in SB92, file 24 from the February 2010 session of the Connecticut General Assembly;, An increase in coverage for magnetic resonance imaging (MRI), as described in SB259, file 89 from the February 2010 session of the Connecticut General Assembly; Source: Connecticut Insurer Survey conducted An increase in coverage for Parkinson's October 2009, University of Connecticut, disease and multiple sclerosis in clinical Center for Public Health and Health Policy trials, as described in SB260, file 247 of the February 2010 session of the Connecticut General Assembly; and An expansion of coverage for gastric bypass surgery.
The CPHHP performed the analysis and developed this report pursuant to a Memorandum of Agreement with the CID. The CPHHP was assisted in the development of this report by the CID and Ingenix Consulting (IC), an actuarial consulting firm. Ingenix was selected through a competitive bidding process managed by the Department.
CPHHP staff researched medical issues, including the conditions addressed by the proposed mandates, the available treatments for those conditions and the medical efficacy of the treatment addressed by the mandate. CPHHP also researched the existence of other types of coverage for the conditions addressed by the mandates, including mandates in other states, Medicare and Medicaid coverage, and programs of other units of state government and non-profit organizations. IC performed the actuarial analyses and the economic and financial burden analysis. IC submitted a separate report, which formed the basis for the actuarial and financial burden analyses included in each of the individual mandate reports by CPHHP.
University of Connecticut Center for Public Health and Health Policy
CPHHP staff consulted with medical librarians at the Lyman Maynard Stowe Library at the University of
Connecticut Health Center (UCHC). Medical librarians conducted literature searches under search terms
particular to each proposed mandate using various resources available to them.
CPHHP staff consulted with clinical faculty and staff from the University of Connecticut School of Medicine on matters pertaining to medical standards of care, current and traditional practices, and evidence-based medicine related to the proposed benefit. Additional information was gathered through telephone and e-mail inquiries to appropriate state, federal, municipal, and non-profit entities and from internet sources such as the State of Connecticut website, Medicare website, other states' websites, and the websites of non- profit and community-based organizations.
CPHHP staff also surveyed the insurance companies and managed care organizations domiciled in Connecticut as to whether their fully-insured group and individual plans currently included the proposed health benefit. Ingenix Consulting
The CID contracted with Ingenix Consulting (IC) to provide actuarial and economic analyses of the
proposed health benefits. Further details regarding the actuarial methods used to estimate the cost of the
benefits and the economic methods used to estimate financial burdens may be found in the IC report, which
is attached as Appendix III. We strongly recommend that this actuarial report and the financial/economic
report be read in conjunction with the individual reports for a more in-depth discussion of the issues
addressed in those reports.
Chapter 1
Prescription Eye Drops
Review and Evaluation of Senate Bill 92, File 24, from the 2010 General Assembly session Expanded coverage of Group Hospital or Medical Insurance Coverage for Prescription Eye Drops Brian L. Benson, MPP University of Connecticut Center for Public Health and Health Policy Chapter 1. Table of Contents
II. Background .8 Table 1.1. Classes of Prescription Eye Drops .10 IV. Social Impact.14 V. Financial Impact.20 Chapter 1. Prescription Eye Drops Chapter 1. Prescription Eye Drops I. Overview
On July 22, 2010, the Chairs of the Insurance and Real Estate committee of the Connecticut General Assembly (the Committee) directed the Connecticut Insurance Department to review the proposed health benefits contained in Senate Bill 92, File Number 24, of the 2010 General Assembly session entitled, "An Act Concerning Prescription Eye Drops" (SB92). This review follows the requirements stipulated under Public Act 09-179. Reviews of required health insurance benefits are a collaborative effort of Connecticut Insurance Department and the University of Connecticut Center for Public Health and Health Policy (CPHHP). SB92 proposed a health benefit for individual and group health insurance issued, renewed or continued in this state that provides coverage for prescription eye drops to also provides coverage for one additional bottle of eye drops once every three months for use at a child's day care center or school. In addition, for individuals of all ages, this proposed health benefit allows for refills of prescription eye drops within less than 30 days: Specifically, Connecticut SB92 states that: Each individual health insurance policy providing coverage of the type specified in subdivisions (1), (2), (4), (11) and (12) of section 38a-469 delivered, issued for delivery, amended, renewed or continued in this state, that provides coverage for prescription eye drops, shall provide coverage for: (1) A renewal of prescription eye drops when (A) the renewal is requested by the insured less than thirty days from the later of (i) the date the original prescription was distributed to the insured, or (ii) the date the last renewal of such prescription was distributed to the insured, and (B) the prescribing physician indicates on the original prescription that additional quantities are needed and the renewal requested by the insured does not exceed the number of additional quantities needed; and (2) One additional bottle of prescription eye drops when (A) such bottle is requested by the insured or the prescribing physician at the time the original prescription is filled, and (B) the prescribing physician indicates on the original prescription that such additional bottle is needed by the insured for use in a day care center or school. Such additional bottle shall be limited to one every three months. Sec. 2. of SB92 contains similar requirements for group health insurance policies. In January of 2011, CPHHP requested information related to the proposed benefit from seven insurers and managed care organizations (MCOs) domiciled in Connecticut that cover over 90 percent of the population in fully insured group and individual health insurance plans in Connecticut (1.25 million persons). Claims data were not available at the time of actuarial analysis. The findings of this report are based on national actuarial claims data analysis and reviews of pertinent literature and other information related to the proposed health benefit.
Current coverage
One carrier confirmed coverage of prescription eye drops as described in the proposed health benefit in
group insurance plan. Other carriers did not provide such coverage or were unable to access data to evaluate
coverage comparable to the proposed health benefit.
Chapter 1. Prescription Eye Drops Chapter 1. Prescription Eye Drops Premium Impact
Group plans: Based on actuarial analysis of national claims data of group plans the medical cost is
estimated to be $0.07 per member per month (PMPM) in 2011. Estimated total cost (insurance premium,
administrative fees, and profit) of the proposed health benefit in 2011 in group plans is $0.10 PMPM,
which is approximately 0.0 percent of estimated total costs in group plans.
Individual policies: When the medical cost of the proposed health benefit is spread to all insureds in
individual policies, medical costs are estimated to be $0.05 PMPM and retention costs are estimated to be
$0.03 PMPM in 2011. Thus, the total effect on insurance premiums is estimated at $0.08 PMPM in 2011.
Self-funded plans
Insurers/MCOs domiciled in Connecticut were unable to provide information regarding coverage of the
services included in the proposed health benefit for the self-funded plans for which they administer benefits.
This report is intended to be read in conjunction with the General Introduction to this volume and the Ingenix Consulting Actuarial Report that is included as Appendix III. II. Background
Prescription eye drops are a sterile solution containing a suspension of drugs which administer medicines directly onto the eye. This method of treatment is effective since most of the medicine remains in the eye and there is less risk of systemic side effects than with oral medicines. A variety of prescription eye drops are used to treat the symptoms and causes of eye conditions such as allergies, chronic dryness, eye infections and chronic disorders. In some cases, prescription eye drops can cure the eye condition; in chronic disorders they can reduce symptoms and slow disease progression. The prescribed regimen for prescription eye drops varies by diagnosis and severity of the condition. For example, depending upon the level of infection, conjunctivitis can be treated with one drop every four hours to 2 drops every hour. The quantity of eye drops per bottle is fairly consistent across medications regardless of the prescribed dosing. As a result, there is some inherent fluctuation in how long one bottle of prescription eye drops will last for a given patient. Medication adherence is essential to properly treat eye diseases, and patients must take the medication as prescribed even if the patient does not feel it is necessary. Conditions such as glaucoma can be treated with long acting medications that require drops only twice a day. However, drops must be administered at regular intervals to maintain proper intraocular pressure. Lack of medication adherence for these patients can increase the need for surgery and the likelihood of vision loss. Prevalence
Allergies. The Allergy and Asthma Foundation of America estimates that 50 million Americans suffer from
all types of allergies. Approximately 4 percent of allergy sufferers (2 million Americans) have eye allergies,
such as allergic conjunctivitis and ocular allergies, as their primary allergies.1 Other estimates suggest that
ocular allergies affect more than 20 percent of the general population.2 Allergic conjunctivitis is most
common in children with allergic rhinitis, seasonal allergies, airborne allergies, asthma and eczema.3
1 Asthma & Allergy Foundation of America. Allergy Facts and Figures. Available at: http://www.aafa.org/display.cfm?id=9&sub=30#_ftnref1. Accessed February 23, 2011. 2 Bielory, L., Katelaris, C.H., Lightman, S., Naclerio, R.M. (2007). Treating the Ocular Component of Allergic Rhinoconjunctivitis and Related Eye Disorders. Med Gen Med, 9(3), 35.
3 Gradman, J., & Wolthers, O.D. (2007). Allergic conjunctivitis in children with asthma, rhinitis and eczema in a secondary outpatient clinic. Chapter 1. Prescription Eye Drops Chapter 1. Prescription Eye Drops Dry Eye Syndrome/Disease (DED). A 2009 study estimates that 1.68 million men 50 years and older
(4.34 percent) suffer from DED, while 2.32 million women (7.8 percent) suffer from DED. The prevalence
of DED is predicted to grow to 2.79 million men in 2030.4 A 2003 study estimated the presence of dry
eye syndrome among adults between the ages of 48 and 91 to be 14.4 percent.5 Based on these studies,
approximately 12-14 percent of adults suffer from dry eye disease.
Bacterial Infections. Reports have found it difficult to identify the prevalence of bacterial eye infections.6
One common result of bacterial eye infections is conjunctivitis causing up to 50 percent of cases.7 Clinically,
it is often difficult to distinguish bacterial from allergic and viral conjunctivitis. Research indicates that
newborn babies are substantially at risk for bacterial eye infections. According to Ferri's Clinical Advisor
2008, conjunctivitis due to bacterial infections is found in 1.6 percent to 12 percent of all newborn babies in
the United States.8 Another report estimates that 1 in 9 (11 percent) children under 15 years old, and 1 in 5
(20 percent) children under 4 years old get conjunctivitis each year.9
Herpes Eye Infections. The National Eye Institute estimates that 400,000 Americans (0.15 percent) have
had some form of ocular herpes, and each year 50,000 new and recurring cases are diagnosed in the United
States.10
Glaucoma. It is estimated that the prevalence of glaucoma among adults 40 years and older in the United
States is 1.9 percent, or 2.2 million persons.11 This number is estimated to increase 50 percent to 3.6
million people in 2020 due to the rapidly aging population.12 In addition, primary open-angle glaucoma is
most prevalent in older African Americans particularly those individuals with a first degree relative diagnosed
with glaucoma.1314 A study of glaucoma prevalence among children in Olmstead County, Minnesota
estimated that the incidence of childhood glaucoma in this population was 1 per 43,575 (.00229 percent)
residents younger than 20 years.15
Table 1.1 lists common classes of prescription eye drops, names of medications, conditions or diseases treated by the medication, and frequency of medication application.16 Pediatric Allergy Immunology, 17(7), 524-6. 4 Schaumberg, D.A., Dana, R., Buring, J.E., & Sullivan, D.A. (2009). Prevalence of Dry Eye Disease Among US Men. Arch Ophthalmol, 127(6), 763-768.
5 Moss, S.E., Klein, R., & Klein, B.E., (2000). Prevalence of and Risk Factors of Dye Eye Syndrome. Arch Ophthalmol, 118(9), 1264-1268. 6 Chung CW, Cohen EJ. 2000. Eye Disorders: Bacterial Conjunctivitis. Western Journal of Medicine 173(3): 202-205.
7 Samsbursky RP. 2007. Acute Conjunctivitis. US Special Populations Pediatrics Review 2007(2). 8 Haddrill M. Pink Eye (Conjunctivitis) Symptoms, Remedies & Prevalence. Available at: Accessed February 25, 2010.
9 Maypole J. Second Opinion: Pinkeye. Avccessed February 25, 201.
10 National Eye Institute. Facts About the Cornea and Corneal Disease. Av Accessed February 23, 2011.
11 Gohdea, D.M., Balamurugan, A., Larsen, B.A., & Maylahn, C. (2005). Age-related Eye Diseases: An Emerging Challenge for Public Health Professionals. Preventing Chronic Disease Public health Research, Practice and Policy, 2(3); see also National Eye Institute. Summary of Eye Disease Prevalence Data. Av. Accessed February 23, 2011.
12 Ibid.
13 Friedman, D.S., Jampel, H.D., Munoz, B., West, S.K. (2006). The prevalence of open-angle glaucoma among blacks and whites 73 years and older: the Salisbury Eye Evaluation Glaucoma Study. Arch Ophthalmol, 124(11), 1625-30. 14 Vistamehr, S., Shelsta, H.N., Palmisano, P.C., Filardo, G., Bashford, K., Chaudhri, K., Forster, S.H., Shafranov, G., Bruce Shields, M. (2006). Glaucoma screening in a high-risk population. Journal of Glaucoma, 15(6), 534-40. 15 Aponte, E.P, Diehl, N., Mohney, B.G. (2010). Incidence and Clinical Characteristics of Childhood Glaucoma. Arch Ophthalmol, 128(4), 16 Monthly Prescribing Guide. 2007. Thomson Healthcare, Montvale, NJ. Chapter 1. Prescription Eye Drops Chapter 1. Prescription Eye Drops Table 1.1. Classes of Prescription Eye Drops
Class
Prescription Name Frequency of application Antihistamine eye 1-2 drops up to 4x/day (6 years and older) 1 drop every 8 to 12 hours (3 years and older) hour intervals (3 years and older) 1 drop up to 4x/day (Emadine)Azelastine 1 drop twice a day (3 years and older) Decongestant eye Tetrahydrozoline 1-2 drops up to 4x/day 1-2 drops of a 0.1% ophthalmic solution every 3 (Vasocon, Allerest) to 4 hours, as needed 1 -2 drops up to 4x/day (6 years and older) combination eye dropsNonsteroidal Allergies and post- 1 drop 3x/day 24 hours prior operative inflammation surgery and 2 weeks post-op.
drug (NSAID) eye in cataract extraction 1 drop 4x/day 24 hours prior surgery and 2 weeks post-op (3 years and older) Corticosteroid eye 1 drop 3 to 4x/day (Fluorometholone, (2 years and older) Allergies and post- 1-2 drops 4x/day. First week (Loteprednol etabonate, operative inflammation of treatment dosing may increase up to 1 drop/hour 1-2 drops 2-4x/day. First 24 (Prednisone acetate, to 48 hours of dosing may be increased if necessary.
Chapter 1. Prescription Eye Drops Chapter 1. Prescription Eye Drops Table 1.1. Classes of Prescription Eye Drops
Class
Prescription Name Frequency of application stabilizers (MCS) (3 years and older) 1-2 drops 4-6x/day at regular (Cromolyn, Crolom) (4 years and older) 1 drop up to 4x/day (3 years and older) 1-2 drops 4x/day for up to 3 months (2 years and older) 1-2 drops 2x/day (3 years and older) 1 drop 2x/day at 6-8 hour stabilizers (MCS) (3 years and older) 1-2 drops 4x/day (3 years and older) Artificial tears/ Dry Eye Syndrome 1-2 drops 3-4x/day Dry Eye Syndrome 1-2 drops 3-4x/day Bacterial conjunctivitis Bacterial Conjunctivitis: 1-2 (Ciprofloxacin, Cipro, and corneal ulcers drops every 2 hours while awake for 2 days than 1-2 drops every 4 hours while awake for 5 days. Corneal Ulcer: 2 drops every 15 minutes for first 6 hours, then 2 drops every 30 minutes for the rest of day 1. 2 drops every hour on day 2. 2 drops every 4 hours on days 3-14. (1 year and older) Chapter 1. Prescription Eye Drops Chapter 1. Prescription Eye Drops Table 1.1. Classes of Prescription Eye Drops
Class
Prescription Name Frequency of application Ocular bacterial 1-2 drops every 4 hours to 2 (Garamycin, Genoptic, infections including drops every hour. conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocysititis. Bacterial conjunctivitis Conjunctivitis: 1-2 drops (Ofloxacin, Floxin) and corneal ulcers every 2-4 hours for 2 days. 1-2 drops 4x/day for 5 days. Corneal Ulcer: 1-2 drops every 30 minutes while awake and 1-2 drops 4-6 hours after retiring for 2 days, then 1-2 drops every 1 hour while awake for 5-7 days, then 1-2 drops 4x/day for 2 days or until treatment completion. (1 year and older) External infections of 1-2 drops every 2 to 3 hours (Sulfex, Cetamide) for 7 to 10 days. External infections of 1-2 drops every 4 hours to 2 the eye and its adnexa. drops every hour. (Adults) External infections of 1 drop 3x/day for 7 days Bacterial conjunctivitis. 1 drop every 2 hours while awake up to 8x/day for 2 days, then 1 drop4x/day while awake for 5 days. (1 year and older) Chapter 1. Prescription Eye Drops Chapter 1. Prescription Eye Drops Table 1.1. Classes of Prescription Eye Drops
Class
Prescription Name Frequency of application Antiviral eye drops Keratoconjunctivitis 1 drop every 2 hours and recurrent epithelial while awake until re- keratitis due to herpes epithelialization. Max 9x/day. Following re-epitheliaization 1 drop 4x/day while awake (6 years and older) Recurrent epithelial 1 drop every 2 hours (8 to 9 keratitis due to herpes doses/day) for 2 to 3 weeks Open-angle glaucoma 1 drop 3x/day every 8 hours. and ocular hypertension (2 years and older) Open-angle glaucoma and ocular hypertension Open-angle glaucoma 1-2 drops 2x/day (Levobunolol, AKBeta) and ocular hypertension Open-angle glaucoma 1-2 drops 2x/day (Betaxolol, Kerlone) and ocular hypertension Open-angle glaucoma and ocular hypertension Open-angle glaucoma 1 drop 2x/day every 8 hours. (Dorzolamide, Trusopt) and ocular hypertension (2 years and older) Open-angle glaucoma 1-2 drops one hour before and ocular hypertension refracting. For uveitis, 1 -2 drops up to 4x/day Open-angle glaucoma 1 drop 1x/day in evening and ocular hypertension Open-angle glaucoma 1 drop every day in pm. (Latanoprost, Xalatan) and ocular hypertension Open-angle glaucoma and ocular hypertension Open-angle glaucoma 1 drop every day. (Cosopt, Timoptic, and ocular hypertension Open-angle glaucoma 1 drop every day in pm. and ocular hypertension Open-angle glaucoma 1 drop up to 4x/day (Pilocarpine, Pilocar, and ocular hypertension Chapter 1. Prescription Eye Drops Chapter 1. Prescription Eye Drops III. Methods
Under the direction of CPHHP, medical librarians at the Lyman Maynard Stowe Library at the University of Connecticut Health Center (UCHC) gathered published articles and other information related to medical, social, economic, and financial aspects of the proposed health benefit. Medical librarians conducted literature searches using PubMed and Scopus, UpToDate, Cochrane Systematic Review, DynaMed, Micromedex, various government websites, and a web search using Google. Some of the search keywords used include Ophthalmic Solutions, Eye drops, Artificial Tears, Antihypertensive Agents, and Antihypertension. CPHHP staff conducted independent literature searches using the Cochrane Review, Scopus, and Google Scholar using similar search terms used by the UCHC medical librarians. Where available, articles published in peer-reviewed journals are cited to support the analysis. Other sources of information may also be cited in the absence of peer-reviewed journal articles. Content from such sources may or may not be based on scientific evidence. CPHHP staff consulted with clinical faculty and staff from the University of Connecticut School of Pharmacy and School of Medicine on matters pertaining to medical standards of care; traditional, current and emerging practices; and evidence-based medicine related to the benefit. Staff gathered additional information through telephone and e-mail inquiries to appropriate state, federal, municipal, and non-profit entities and from internet sources such as the State of Connecticut website, Centers for Medicare and Medicaid Services (CMS) website, other states' websites, professional organizations' websites, and non-profit and community-based organization websites.
With the assistance of the Connecticut Insurance Department (CID), CPHHP and Ingenix Consulting requested information regarding the proposed health benefit from seven insurance companies and MCOs domiciled in Connecticut. Four insurers provided information about current levels and policies of prescription eye drop coverage. CPHHP and the CID contracted with Ingenix Consulting (IC) to provide actuarial and economic analyses of the proposed health benefit. Further details regarding the insurer/MCO information and actuarial methods used to estimate the cost of the proposed health benefit and may be found in Appendix III. IV. Social Impact
1. The extent to which prescription eye drops is utilized by a significant portion of the population.
Connecticut's estimated population covered by fully insured group health insurance plans and individual
policies with pharmacy benefits is 985,562 or 33 percent of the population under 65 years old.17 Therefore,
if the proposed health benefit was enacted, it would be available to this population. According to the IC
analysis, an estimated 164 prescriptions for eye drops per 1000 privately insured children in Connecticut
were covered in 2009. Additionally, an estimated 159 prescriptions for eye drops per 1000 privately insured
Connecticut residents of all ages were covered in 2009. Due to difficulties in obtaining information about
prescription eye drops under the definitions listed in the proposed statute, precise estimates of utilization of
proposed health benefit are not available.
17 University of Connecticut, Center for Public Health and Health Policy. 2009. Review and Evaluation of Public Act 09-188, An Act Concerning Wellness Programs and Expansion of health insurance coverage. University of Connecticut. Available at: Accessed October 8, 2010.
Chapter 1. Prescription Eye Drops Chapter 1. Prescription Eye Drops 2. The extent to which Prescription eye drops are available to the population, including, but not
limited to, coverage under Medicare, or through public programs administered by charities,
public schools, the Department of Public Health, municipal health departments or health districts
or the Department of Social Services.
Medicare
Medicare generally covers prescription eye drops as required by a physician or optometrist.
Part D plans cover prescription drugs including the cost of prescription eye drops needed for the treatment of eye diseases and conditions. For example, Part D plans cover Pilocarpine HCI and Xalatan, prescription eye drops used to treat glaucoma.18 The Medicare policy regarding coverage of an additional bottle of prescription eye drops is unknown and is likely to vary among Part D plans. Public Programs Administered by Charities
The American Optometric Association (AOA) operates a program called Vision USA. The program provides
free eyeglasses and screenings to individuals who qualify. However, no mechanism is in place to offer
financial assistance to individuals needing prescription eye drops.19
Public Programs Administered by Public Schools
School Based Health Centers (SBHCs) are free-standing medical clinics within or on school grounds.
SBHCs are located in schools predominantly serving low-income minority children. Among the services
is the prescribing and dispensing of medications.20 In 2006-2007, 68 state-funded SBHC sites in 19
communities provided health services to more than 20,000 students in grades Pre-K to 12. SBHCs may
provide services related to the mandate.
The Department of Public Health (DPH)
No information was found that would indicate the state Department of Public Health provides services for
prescription eye drops.
Municipal Health Departments
No information was found that would indicate Connecticut municipal health departments or health districts
provide services related to the proposed health benefit.
The Department of Social Services (DSS)
Medicaid covers a number of prescription eye drops used to treat eye diseases and conditions such as
glaucoma. Among prescription eye drops covered are Pilocarpine, Tetrahydrazoline, and Xalatan.21 DSS
uses prior authorization for dispensing early refills of prescription drugs.
3. The extent to which insurance coverage is already available for the treatment, service or
equipment, supplies or drugs, as applicable.
The extent to which insurance coverage is already available for additional bottles of prescription eye drops is dependent on several factors. State of Connecticut law does not require coverage for prescriptions in general or specifically for prescription eye drops in fully insured group plans and individual policies marketed in 18 Medicare Plans and Formularies. Available at: http://plancompare.medicare.gov/pfdn/FormularyFinder/DrugSearch#divSearchResult. Accessed January, 24, 2011.
19 Personal Communication. Sandi Gregson, Community Health Programs Coordinator. Vision USA. February 7, 2011. 20 Connecticut Department of Public Health. 2009. School Based Health Centers. Available at: . Accessed December 29, 2010.
21 Department of Social Services. Drug Search. Av Accessed January 24, 2011.
Chapter 1. Prescription Eye Drops Chapter 1. Prescription Eye Drops Connecticut. One carrier confirmed coverage of prescription eye drops as described in the proposed health benefit in group insurance plan. Other carriers did not provide such coverage or were unable to access data to evaluate coverage according to the proposed health benefit. Currently, fully insured group and individual plans are not required to renew prescription eyes drops less than thirty days from the date of the original prescription to provide an additional bottle of prescription eye drops for use in day care or school settings when coverage is limited to one every three months. 4. If the coverage is not generally available, the extent to which such lack of coverage results in
persons being unable to obtain necessary health care treatment.
Coverage for prescription eye drops is generally available for persons enrolled in fully insured group health insurance plans and individual health policies that include prescription drug benefits. Currently, fully insured group and individual plans are not required to renew prescription eyes drops less than thirty days from the date of the original prescription or provide an additional bottle of prescription eye drops for use in day care or school settings. The lack of current coverage for the proposed health benefit may result in persons being unable to obtain necessary health care treatment if they are unable to purchase additional quantities out-of-pocket. 5. If the coverage is not generally available, the extent to which such a lack of coverage results in
unreasonable financial hardships on those persons needing treatment.
As noted above, coverage for prescription eye drops services as defined in the proposed health benefit is not currently included in fully insured group health insurance plans and individual policies issued in Connecticut. Depending on the level of cost sharing for the initial prescription and personal financial resources available, the current lack of coverage may contribute to unreasonable financial hardship for the insured's family. Prescription eye drops are generally required for treatment of common infections and serious medical conditions which could lead to loss of sight. For patients and their families, significant health and economic costs may accrue, even for those with comprehensive health benefits. Additionally, loss of work time, income and school attendance are common for patients and parents of children requiring prescription eye drops. Additional costs associated with illness and disease (e.g., travel) that are not covered by health insurance may also accrue. For some individuals and families, such costs can add to the unreasonable financial hardships beyond those attributed to medical services.
Further discussion of financial and socioeconomic effects of prescription eye drops may be found in Appendix IV: Ingenix Consulting Financial and Socioeconomic Report.
6. The level of public demand and the level of demand from providers for prescription eye drops.
At the time the Bill was under consideration, testimony was received in support of the service and insurance
coverage from the public and providers. Members of the community, leaders of professional organizations,
and providers advocated for renewal of prescription eye drops in less than 30 days or one additional bottle of
prescription eye drops for use in day care or school settings, noting the importance for effective treatment.
For example, many patients who use prescription eye drops may finish their allotted doses in less than 30
days. Frequently, patients in this situation are elderly, or have other conditions such as arthritis or Parkinson's
disease which may contribute to inaccurate application of the prescription eye drops. Patients may also be
on fixed incomes making purchase of an additional prescription out-of-pocket financially difficult. As a
result, patients who need to stay on continuous therapy for sight threatening illnesses like glaucoma may
have to suspend treatment while they wait for the subsequent refill. Treatment adherence is essential for
Chapter 1. Prescription Eye Drops Chapter 1. Prescription Eye Drops many patients with eye disease in order to reduce disease progression and potential blindness. In addition, some young patients require eye drops for sight threatening conditions like corneal infections or uveitis that can lead to glaucoma, cataracts and permanent vision loss. Treatment for such conditions can be long-term and require frequent applications. Since children spend a considerable amount of time in school and day care, prescription eye drops sometimes must be administered away from home. Transporting prescription eye drops via school bus, etc. can increase the likelihood that they get lost or become non-sterile rendering them unusable and necessitating a replacement bottle. Coverage for a second bottle of eye drops for use at school or day care would only be required when explicitly requested by the ordering provider and limited to once every three month.22 7. The level of public demand and the level of demand from providers for insurance coverage for
prescription eye drops.
In Connecticut, public and provider support for coverage of this service is documented in the public testimony received during the time the Bill was under consideration for passage by the general assembly (as noted above in Question 6). 8. The likelihood of achieving the objectives of meeting a consumer need as evidenced by the
experience of other states.
No information was found that would indicate other states require coverage of an additional bottle of prescription eye drops.23 However, New York has a proposed health insurance mandate for prescription eye drops that closely parallels Connecticut's proposed health benefit. New York Senate Bill 1430 amends certain sections of the insurance law to allow for the refill of prescription eye drops when the refill is requested prior to the expiration of the period of suggested use.24 9. The relevant findings of state agencies or other appropriate public organizations relating to the
social impact of the proposed health benefit.
Thirty states now require a fiscal note or an additional review process for any new required health insurance benefit prior to enactment.25 States may also review existing health insurance mandates periodically. Internet searches and telephone inquiries found no studies from state agencies and public organizations related specifically to the social impact of prescription eye drops as defined in the statute. States for which no evidence of a review was found include California, Colorado, Maryland, Maine, Massachusetts, Virginia, Wisconsin, Louisiana, New Jersey, Pennsylvania, Washington and Texas. 10. The alternatives to meeting the identified need, including but not limited to, other treatments,
methods or procedures.
Currently, there are limited equally safe and effective alternatives to treat eye disease. Recent interest in the benefits of complementary and alternative medicine (CAM) (including acupuncture to treat glaucoma) has increased its use.26 However, the effectiveness of most CAM treatments has not been established reliably enough for medical providers to employ them in place of traditional medications. Surgery may be necessary 22 Connecticut General Assembly. Report on Bills Favorably Reported By Committee. Insurance and Real Estate Committee. SB-92. February 23 NAIC Compendium of State Laws on Insurance Topics. National Association of Insurance Commissioners. A May 2010.
24 New York State Assembly. Coverage for refills of prescription eye drops. S-1430. Available at: Accessed February 25, 2011.
25 National Conference of State Legislatures. 2009. Health insurance coverage mandates: Are they too costly? Presentation at the Louisiana Department of Insurance 2009 Annual Health Care Conference. May 28, 2009. Available at: ccessed May 7, 2010.
26 Law, S.K., Li, T. (2010). Acupuncture for glaucoma. The Cochrane Collaboration. John Wiley & Sons. Chapter 1. Prescription Eye Drops Chapter 1. Prescription Eye Drops for conditions such as cataracts and detached retina. However, prescription eye drops are typically necessary after surgery for infection prevention, pain relief, and to decrease intraocular pressure. 11. Whether the benefit is a medical or broader social need and whether it is consistent with the role
of health insurance and the concept of managed care.
Extended coverage of prescription eye drops fulfills medical needs. Prescription eye drops are effective in treating serious chronic medical conditions, common infections, and allergies. They are frequently necessary as part of the process of recovery from injury or post-operative rehabilitation.
In terms of social needs, prescription eye drops can facilitate or maintain levels of functioning that allow individuals to live independently including being able to go to work and school. In addition, research has shown an association between decreased quality of life and eye disease due in part to interference with reading, night driving, working at a computer screen, eye discomfort and blurred vision.27 One of the roles of health insurance is to cover unexpected health care costs. Adequate supply of prescription eye drops as defined in the proposed health benefit are required for medication adherence and effective treatment As such, the proposed services are consistent with the role of health insurance and the concept of managed care.
12. The potential social implications of the coverage with respect to the direct or specific creation of a
comparable mandated benefit for similar diseases, illnesses, or conditions.
It is possible that the basic structure of the proposed health benefit could be replicated for other types of prescription services, e.g., ointments that may need to be applied during day care or school hours, or inhalers that may be necessary for swift administration of asthma drugs. These prescriptions are also susceptible to being misplaced requiring an early refill. 13. The impact of the benefit on the availability of other benefits currently offered.
The impact of the proposed health benefit on the availability of other benefits currently offered is expected
to be minimal because it is a low cost benefit.
Insurers and MCOs may cut costs by eliminating or restricting access to, or placing limits on other non-mandated benefits currently offered. However, the availability of any benefit to be restricted may be limited. Existing benefits may be administratively costly to restrict and insurers may be contractually obligated to provide them. Additionally, many of the benefits that could be targets for elimination are included in plans for competitive advantage. 14. The impact of the benefit as it relates to employers shifting to self-insured plans and the extent to
which the benefit is currently being offered by employers with self-insured plans.
There are several reasons for health insurance premium increases, including medical cost inflation, an aging population and an aging workforce, and required benefits or "mandates." Employers contemplating a shift to self-funded plans are likely to weigh these and other factors. Employers also may shift to plans with higher coinsurance amounts to keep premiums at a more affordable level ("benefit buy down"). Benefit buy down can result in employees not taking up coverage and thus being uninsured or not accessing care when it is needed because of high deductibles.
Coverage under self-funded plans is unknown. 27 Friedman, N.J. (2010). Impact of dry eye disease and treatment on quality of life. Current Opinion in Ophthalmology, 21, 310-316. Chapter 1. Prescription Eye Drops Chapter 1. Prescription Eye Drops 15. The impact of making the benefit applicable to the state employee health insurance or health
As a self-funded entity, the state employee health insurance or health benefits plan is exempt from state health insurance mandates under the federal Employee Retirement Income Security Act (ERISA). If the state voluntarily provided the services included in the proposed health benefit under review, the social impact of the benefit for the approximately 134, 344 covered lives in the state employee plans and 30,000 state retirees not enrolled in Medicare is expected to be the same or similar to the social impact for persons covered in non-state employee health insurance plans as discussed throughout Section IV of this report.
The actuarial analysis estimates the costs of the services included in the proposed health benefits would be $0.10 PMPM in the fully-insured group population. In terms of financial impact to the state employee health insurance or health benefits plan, there is little reason to expect that the PMPM estimate would vary significantly from the fully insured group population estimate. 16. The extent to which credible scientific evidence published in peer-reviewed medical literature
generally recognized by the relevant medical community determines prescription eye drops to be
safe and effective.
Prescription eye drops, when used appropriately are generally safe and effective for a variety of medical conditions. In children cyclosporine eye drops, at one percent or two percent concentration, were found to be safe and effective for long-term treatment of vernal keratoconjunctivitis, a chronic and potentially sight-threatening disease.28 In addition, topical apraclonidine 0.5 percent has been found to be safe and effective for short-term treatment in a pediatric glaucoma sample, both perioperative and postoperative.29 The findings were based on a retrospective chart review of 115 eyes of 75 pediatric glaucoma patients who received apraclonidine 0.5 percent drops for a total of 179 sessions. The average age of the patients was 5.3 months (range, 0.1 month to 17 years). Nonthreatening side effects were noted in eight percent of children (e.g. topical allergy, lethargy, and decreased appetite). In adult patients, the use of a fixed combination therapy with the carbonic anhydrase inhibitor dorzolaminde hydrochloride 2 percent and the beta blocker timolol maleate 0.5 percent was found to be safe and efficacious, and well tolerated.30 In addition to the medical benefits, combining the two medications was also found to be convenient for patients since fewer doses were required contributing to increased adherence and reduced effects of "washout" when instilling multiple drops. In addition, the use of topical corticosteroids combined with the appropriate antibiotic in the treatment of bacterial keratitis can be effective in limiting permanent corneal damage in adults.31 However, the use of some prescription eye drops poses possible serious side effects, toxicity, and drug interactions. For example, brimonidine, a medication to lower intraocular pressure, has been prescribed to treat children although it is not licensed for this use. Only a few case reports and small retrospective studies have investigated its safety and efficacy in this population. Findings indicate potentially fatal systemic side effects including: bradycardia, hypotension, hypotonia, apnea, dyspnea, hypoventilation, cyanosis and lethargy. Although there are no concrete guidelines, extreme caution should be taken when treating children 28 Pucci, N., Caputo, R., Mori, F, De Libero, C., Di Grande, L., Massai, C., Bernardini, R., Novembre, E. (2010). Long-term safety and efficacy of topical cyclosporine in 156 children with vernal keratoconjunctivitis. International Journal of Immunopathology Pharmacology, 23, 3, 865-71.
29 Wright, T.M., & Freedman, S.F. (2009). Exposure to topical apraclonidine in children with glaucoma. Journal of Glaucoma. 18(5), 395-398. 30 Bell, N.P., Ramos, J.L., & Feldman, R.M. (2010). Safety, tolerability, and efficacy of fixed combination therapy with dorzolamide hydrochloride 2% and timolol maleate 0.5% in glaucoma and ocular hypertension. Clinical Ophthalmology, 4, 1331-1346. 31 Hindman, H.B., Patel, S.B., & Jun, A.S. (2009). Rational for adjuctive topical corticosteroids in bacterial keratitis. Arch Ophthalmol, 127, 1, Chapter 1. Prescription Eye Drops Chapter 1. Prescription Eye Drops weighing less than 20 kg and those younger than six years of age.32 In addition, in a study investigating the risk of cataract development among patients with juvenile idiopathic arthritis (JIA)- associated uveitis treated with topical corticosteroids, findings indicate an increased risk of cataract formation independent of active uveitis or presence of posterior synechiae. However, chronic use of topical corticosteroids dosed at three or fewer drops daily seemed to be associated with a lower risk of cataract development relative to eyes receiving higher dose over follow-up in the suppression of uveitis.33 Research has found that beta-blockers used to treat glaucoma in adults may be inappropriate for patients with cardiopulmonary disease.34 In addition, prostaglandin analogues, also used to treat glaucoma, should not be used with patients with lightly pigmented irises (irises could change color) and patients with a history of uveitis or recent intraocular surgery.35 IV. Financial Impact
1. The extent to which the proposed health benefit may increase or decrease the cost of the treatment,
service or equipment, supplies or drugs, as applicable, over the next five years.
The proposed health benefit is not expected to materially alter the availability or cost of prescription eye drops over the next five years. In general, prescription eye drops are a low cost and infrequently needed health service. The additional cost of a refill in less than 30 days, or a second bottle every three months to be used in a day care or school setting, is not expected to have any additional effect on the unit cost of treatment. The costs of the services are likely to increase (or decrease) at the same rates as other medical services.
2. The extent to which the proposed health benefit may increase the appropriate or inappropriate use
of Prescription eye drops over the next five years.
For those individuals whose insurance plans would not otherwise cover additional bottles of prescription eye drops, the proposed health benefit may increase appropriate use of the service. For those who are covered by self-funded plans, who use out-of-pocket funds, or who receive additional bottles of prescription eye drops from other sources, a mandated benefit may not increase appropriate use. Prescription eye drops are formulated to address specific medical needs and inappropriate use is not expected to occur as a result of the proposed health benefit. 3. The extent to which prescription eye drops may serve as an alternative for more expensive or less
expensive treatment, service or equipment, supplies or drugs, as applicable.
Medically necessary prescription eye drops are required for treatment to be effective for children and adults diagnosed with eye disease or infections. Such treatment does not serve as an alternative for any other treatment, service or equipment, supplies or drugs. Lack of any medically necessary care often leads to complications (disease progression and loss of sight) and more extensive treatment (surgery, laser treatment), that is more expensive than the care forgone at the earlier treatment opportunity.
4. The methods that will be implemented to manage the utilization and costs of the proposed health
32 Fudemberg, S.J., Batiste, C., Jay Katz, L. (2008). Efficacy, safety and current application of brimonidine. Expert Opinion Drug Safety. 7(6), 33 Thorne, J.E., Woreta, F.A., Dunn, J.P., & Jabs, D.A. (2010). Risk of cataract development among children with juvenile idiopathic arthritis- related uveitis treated with topical corticosteroids. Ophthalmology, 117, 7,1436-1441.
34 Fudemberg, S.J., Bastiste, C. & Katz, L.J. (2008). Efficacy, safety, and current applications of brimonidine. Expert Opinion Drug Safety, 7(6), Chapter 1. Prescription Eye Drops Chapter 1. Prescription Eye Drops It is anticipated that insurers and MCOs would employ the same utilization management methods and cost controls that are implemented with other covered benefits. The legislation does not prohibit insurers and MCOs from employing utilization management, prior authorization, or other utilization tools at their discretion. 5. The extent to which insurance coverage for an additional bottle of prescription eye drops may be
reasonably expected to increase or decrease the insurance premiums and administrative expenses
for policyholders.
Insurance premiums include medical cost and retention costs. Medical cost accounts for medical services. Retention costs include administrative cost and profit (for for-profit insurers/MCOs) or contribution to surplus (for not-for-profit insurers/MCOs). For further discussion, please see Appendix III, Ingenix Consulting Actuarial Report, page 10-11.
Group plans: When the medical cost of the proposed health benefit is spread to all insureds in group
plans, medical costs are estimated to be $0.07 PMPM and retention costs are estimated to be $0.03 PMPM
in 2011. Thus, the total effect on insurance premiums is estimated at $0.10 PMPM in 2011. Insurance
coverage for the proposed health benefit could reasonably be expected to increase group health insurance
premiums accordingly, that is, $1.20 per year per insured.
Individual policies: When the medical cost of the proposed health benefit is spread to all insureds in
individual policies, medical costs are estimated to be $0.05 PMPM and retention costs are estimated to be
$0.03 PMPM in 2011. Thus, the total effect on insurance premiums is estimated at $0.08 PMPM in 2011.
Insurance coverage for the proposed health benefit could reasonably be expected to increase individual health
insurance premiums accordingly, that is, $0.96 per year per insured.
For further information, please see the Appendix III: Ingenix Consulting Actuarial Report.
6. The extent to which an additional bottle of prescription eye drops are more or less expensive than
an existing treatment, service or equipment, supplies or drugs, as applicable, that is determined
to be equally safe and effective by credible scientific evidence published in peer-reviewed medical
literature generally recognized by the relevant medical community.
An additional bottle of prescription eye drops as defined in the proposed health benefit provide for medication tailored for individual patient needs as directed by the prescribing physician. At present there are limited equally safe and effective alternatives to treat eye disease. Recent interest in the benefits of complementary and alternative medicine (CAM) (including acupuncture to treat glaucoma) has increased its use.36 However, the effectiveness of most CAM treatments has not been established reliably enough for medical providers to employ them in place of traditional medications. Surgery may be necessary for conditions such as cataracts and detached retina. However, prescribed eye drops are typically necessary after surgery for infection prevention, pain relief, and to decrease intraocular pressure. 7. The impact of insurance coverage for prescription eye drops on the total cost of health care,
including potential benefits or savings to insurers and employers resulting from prevention or
early detection of disease or illness related to such coverage.
The total cost of health care is understood to be the funds flowing into the medical system, which are the medical costs of insurance premiums and cost sharing. Actuarial analysis shows a projected cost in 2011 of $2,405,871 for expanded coverage of prescription eye drops for Connecticut residents covered by fully-insured group health insurance plans. Of the total cost, $1,122,740 is for insurer/MCO paid medical costs 36 Law, S.K., Li, T. (2010). Acupuncture for glaucoma. The Cochrane Collaboration. John Wiley & Sons. Chapter 1. Prescription Eye Drops Chapter 1. Prescription Eye Drops and $1,283,131 represents cost-sharing paid out-of-pocket by patients for the additional eye drops. Cost sharing represents 53.3 percent of the predicted increase in the total cost of health care.
In many cases the consistent application of prescription eye drops may prevent disease progression and loss of sight resulting in reduced medical complications and their associated costs. 8. The impact of the proposed health benefit on the cost of health care for small employers, as defined
in § 38a-564 of the general statutes, and for employers other than small employers.
No published literature was found regarding the impact of proposed health benefit of coverage for prescription eye drops as defined in the statute on the cost of health care for small employers. Although small employers may be more sensitive to premium increases than other employers, the estimated low cost of the proposed health benefit ($0.10 PMPM) on insurance premiums in fully-insured group plans suggests little differences in effects among different sized employers. For further information regarding the differential effect of the proposed health benefit on small group vs. large group insurance, please see Appendix III: Ingenix Consulting Actuarial Report, page 22-23.
9. The impact of the proposed health benefit on cost-shifting between private and public payers of
health care coverage and on the overall cost of the health care delivery system in the state.
Cost-shifting between private and public payers of health care coverage generally occurs when formerly privately insured persons, after enrolling in a public program or becoming un- or underinsured, require and are provided health care services. Cost-shifting also occurs when a formerly publicly-funded service becomes the responsibility of private payers, which can result following enactment of a health insurance mandate. Most persons formerly covered under private payers lose such coverage due to a change in employer, change in employment status, or when private payers discontinue offering health care coverage as an employee benefit or require employee contributions to premiums that are not affordable. Due to the low incidence of prescription eye drops in Connecticut and in the insured population, the proposed health benefit is not estimated to have an impact on cost-shifting between private and public payers. If enacted, medical costs of the proposed health benefit are estimated to be $0.07 PMPM and retention costs are estimated to be $0.03 PMPM in 2011. Thus, the total effect on insurance premiums is estimated at $0.10 PMPM in 2011. Insurance coverage for the proposed health benefit could reasonably be expected to increase group health insurance premiums accordingly, that is, $1.20 per year per insured.
The overall cost of the health delivery system in the state is understood to include total insurance premiums (medical costs and retention) and cost sharing. Actuarial analysis shows a projected cost in 2011 of $2,874,311 for expanded coverage of prescription eye drops for Connecticut residents covered by fully-insured group insurance plans. Of the overall cost, $1,122,740 is for paid medical costs, $1,283,131 for cost sharing, and $468,440 for retention. Cost sharing paid out-of-pocket accounts for 44.6 percent of the overall cost increase.
For further information, please see Appendix III, Ingenix Consulting Actuarial Report.
Chapter 1. Prescription Eye Drops Chapter 1. Prescription Eye Drops Chapter 2
An Increase in Coverage for
Magnetic Resonance Imaging
Review and evaluation of Senate Bill 259, file 89 2010 February Session Mary U. Eberle, JD University of Connecticut Center for Public Health and Health Policy Chapter 1. Prescription Eye Drops Chapter 1. Prescription Eye Drops Chapter 2. Table of Contents
II. Background .27 IV. Social Impact.31 V. Financial Impact.34 I. Overview
Pursuant to Public Act 09-179, An Act Concerning Reviews of Health Insurance Benefits Mandated in this State, the chairs of the Committee on Insurance and Real Estate of the Connecticut General Assembly directed the Connecticut Insurance Department to review the proposed health insurance benefit mandates contained in their letter of July 22, 2010 (attached as Appendix I). This report is a part of that review and was conducted following the requirements stipulated under Public Act 09-179. The review is a collaborative effort of the Connecticut Insurance Department and the University of Connecticut Center for Public Health and Health Policy.
Senate Bill 259, file 89, from the 2010 February Session (SB259) would require both individual and group health insurance policies to provide benefits for magnetic resonance imaging (MRI) of an entire breast or breasts, in addition to annual mammograms, in certain circumstances. Specifically, SB259 section 2 would amend CGSA sec. 38a-530 as follows: (a) (1) Each group health insurance policy providing coverage of the type specified in subdivisions (1), (2), (4), (11) and (12) of section 38a-42 469 delivered, issued for delivery, renewed, amended or continued in this state [on or after October 1, 2001,] shall provide benefits for mammographic examinations to any woman covered under the policy which are at least equal to the following minimum requirements: [(1)] (A) A baseline mammogram for any woman who is thirty-five to thirty-nine years of age, inclusive; and [(2)] (B) a mammogram every year for any woman who is forty years of age or older. (2) Such policy shall provide additional benefits for comprehensive ultrasound screening and
magnetic resonance imaging, of an entire breast or breasts if a mammogram demonstrates
heterogeneous or dense breast tissue based on the Breast Imaging Reporting and Data System
established by the American College of Radiology or if a woman is believed to be at increased
risk for breast cancer due to family history or prior personal history of breast cancer, positive
genetic testing or other indications as determined by a woman's physician or advanced
practice registered nurse.
(b) Benefits under this section shall be subject to any policy provisions that apply to other services covered by such policy. (c) On and after October 1, 2009, each mammography report provided to a patient shall include information about breast density, based on the Breast Imaging Reporting and Data System established by the American College of Radiology. Where applicable, such report shall include the following notice: "If your mammogram demonstrates that you have dense breast tissue, which could hide small abnormalities, you might benefit from supplementary screening tests, which can include a breast ultrasound screening or a breast MRI examination, or both, depending on your individual risk factors. A report of your mammography results, which contains information about your breast density, has been sent to your physician's office and you should contact your physician if you have any questions or concerns about this report.". (Bracketed language would be deleted from and underlined language would be added to the Connecticut General Statutes by this bill.) Section 1 of SB259 contains essentially the same provisions for individual health insurance policies. SB259 is attached to this report as Appendix II.
N.B. Based on the existing language of CGSA sections 503 and 530, it is assumed for purposes of this report that SB259 would mandate coverage of breast MRIs when used for screening purposes where there are no signs or symptoms of disease, rather than when used for diagnostic purposes after an abnormality has been found or when used in concert with various treatments after breast cancer has been diagnosed. Health insurance policies generally already cover MRIs in the latter two circumstances.
In January 2011, CPHHP and Ingenix Consulting (IC) requested information related to the proposed mandated benefit from seven insurers and managed care organizations (MCOs) domiciled in Connecticut that cover approximately 90 percent of the population in fully-insured group and individual health insurance plans in Connecticut (1.25 million persons). Based on the survey responses, a review of the legislative history, reviews of pertinent literature and the Ingenix Consulting report, this review found the following:. Current coverage
Connecticut-domiciled insurers/MCOs reported that 100 percent of their fully insured policies have
coverage for breast MRI in at least some circumstances. Two carriers reported that their policies covered
breast MRI, subject to their medical necessity guidelines, which generally follow the guidelines of the
American Cancer Society. One of these two carriers allows coverage for screening MRIs when the patient
has a personal history of breast cancer or has dense breasts. See Social Impact question number 3 below for a
more detailed discussion.
Premium impact
Group plans: On a 2011 basis, the medical cost of this proposed mandate is estimated to be $0.92 per
member, per month (PMPM). Estimated total cost to insurers (medical cost, administrative fees, and profit)
of the mandated services on a 2011 basis in group plans is $1.10 PMPM, which is 0.3 percent of estimated
total premium costs in group plans. The Affordable Care Act prohibits cost sharing for preventive services
after 2010, so estimated cost sharing is $0.00 PMPM.
Individual policies: On a 2011 basis, medical cost is estimated to be $0.62 PMPM. Estimated total cost
(medical cost, administrative fees, and profit) of the mandated services in 2011 in individual plans is $0.80
PMPM, which is 0.3 percent of estimated total premiums in individual plans. The Affordable Care Act
prohibits cost sharing for preventive services after 2010, so estimated cost sharing is $0.00 PMPM.
Self-insured plans
Information received from five insurers/MCOs domiciled in Connecticut indicates that 100 percent of
members in self-funded plans of three of the insurers/MCOs have coverage for the proposed mandated
benefit. The other two insurers/MCOs were unable to provide information on their self-funded plans
within the time frame of the survey.
This report is intended to be read in conjunction with the General Introduction to this volume and the Ingenix Consulting Actuarial Report which is included as Appendix III.
Chapter 2. Breast MRI Chapter 2. Breast MRI Breast cancer is the most common cancer diagnosed in women in the United States.37 According to the Connecticut Department of Public Health (CTDPH), it is also the most commonly diagnosed cancer in women in Connecticut.38 In 2004, there were 2706 diagnoses of new malignant breast cancers in Connecticut. Breast cancer is the second-leading cause of cancer deaths in women in Connecticut, with 552 deaths in 2004.39 Women at average risk of developing breast cancer have approximately a 12 percent chance of developing breast cancer over their lifetimes.40 The risk of developing breast cancer increases with age. Women aged 30-39 have a one in 233 chance of developing breast cancer in the next ten years. Women aged 60-69 have a one in 29 chance. According to the CTDPH, three out of four new cancers in 2004 were found in women over 50 years of age. Risk
Certain women are at higher than average risk of developing breast cancer. Genetic testing for certain gene
mutations; a family history of breast cancer in first or second degree relatives, especially before age 40; and a
woman's own clinical history are used to identify such women.
Women who have certain genetic mutations, such as the BRCA1 or BRCA2 genes, are at very high risk. The American Cancer Society reports that women with the BRCA1 gene mutation have a 65 percent risk of developing breast cancer by age 70. Women with the BRCA2 gene mutation have a 45 percent risk. Women from certain cancer-prone families can have a risk as high as 85 percent.41 The prevalence of such mutations ranges from 1/500 to 1/1000 in the general population, but women of Ashkenazic Jewish descent have a 1/50 prevalence.
Women in families with a significant history of breast cancer among first and second degree relatives are at increased risk of having a gene that carries a high rate of risk of breast cancer. A woman from a family with a known BRCA mutation is at high risk even if she has not been tested for the mutation. However, a woman from such a family who tests negative for the mutation is at no greater risk than the average woman for developing breast cancer A woman from a high risk family where there is no known gene mutation is at high risk even if she is tested and no mutation is found. Certain clinical factors are associated with increased risk. Women who have had radiation of the chest to treat Hodgkin's disease, if done between the ages of 10 and 30, have a significant risk of developing breast cancer 15-30 years after treatment, although this may not be true of women treated after 1974 with newer radiotherapy methods. Women who have had certain types of noninvasive cancers or atypical hyperplasia can be at 4-10 times greater risk of developing invasive breast cancer. Breast density can also increase a woman's risk of breast cancer. The ACS guidelines cite studies that found a four- to six-fold increase in risk between women with the most dense breasts and those with the least dense breasts.42 37 American Cancer Society. 2011. American Cancer Society Guidelines for Breast Screening with MRI as an adjunct to Mammography. CA Cancer J Clin 57(1);75-89. 38 Connecticut Department of Public Health. 2007. Breast Cancer in Connecticut Avccessed on February 24, 2011.
39 Ibid.
40 National Cancer Institute. 2010. Probability of Breast Cancer in American Women. Available at: Accessed on February 24, 2011.
41 Saslow D, Boetes C, Burke W et al. 2007. American Cancer Society Guidelines for Breast Screening with MRI as an Adjunct to Mammography. CA Cancer J Clin 57(2);75-89. Downloaded from caonline.americancancersoc.org on February 9, 2011.
42 Ibid. p. 78-79.
Chapter 2. Breast MRI Chapter 2. Breast MRI There are two decision-making models that assist physicians in estimating the likelihood that a particular woman has a BRCA mutation: BRCAPRO and BOADICEA. BOADICEA also can estimate a woman's risk of developing breast cancer.43 The ACS guidelines for use of MRIs as a screening tool are based on the level of risk for a particular woman as determined by these or similar models.
Screening modalities
Screening and early diagnosis have been shown to reduce morbidity and mortality from breast cancer among
women between the ages of 40 and 74.44, 45 Five year survival rates for breast cancer are highest when it is
detected at the earliest stages, before it has spread beyond the breast.46 Regular mammograms and clinical
breast examination by a trained health care provider are the most effective ways to detect breast cancer
early.47
However, mammograms are not perfect. Screening mammograms can miss up to 20 percent of breast cancers that are present at the time of screening.48 Such false-negative results occur most often as a result of dense breast tissue. Dense tissue and tumors have a similar appearance on a mammogram, making it harder to detect a tumor. Dense tissue is more common among young women than among older women, because breast tissue generally becomes more fatty and less dense as women age. Mammograms can also result in false-positive reports, which can result in unnecessary follow-up procedures such as biopsies for what turn out to be benign abnormalities. On balance, such risks are deemed to be outweighed by the benefits of early detection.
Breast ultrasound uses high frequency sound waves to develop a picture of the breast tissue. It is noninvasive and does not use radiation. It is most often used as a diagnostic aid when a mammogram or clinical breast exam has detected an abnormality. Some studies have shown that screening women with very dense breasts using both mammogram and ultrasound can find more cancers than screening with mammography alone.49 Magnetic resonance imaging (MRI) uses magnetic fields and radio waves to produce very detailed cross-sectional pictures of the body. Contrast MRIs use a contrast agent injected into a vein either before or during the MRI to provide enhanced detail. MRI is used primarily as a diagnostic tool or as an adjunct to treatment for diagnosed breast cancer, but it can also detect some cancers that are missed on mammograms, especially in dense breast tissue. However, it has a higher rate of false-positive results than mammography, leading to more follow-up procedures and biopsies than are needed. MRIs of the breast are most accurate when performed on a breast MRI machine, as opposed to an MRI machine designed for chest or abdominal scanning. Not all hospitals or imaging centers have such specialized equipment.50 All three imaging technologies require physicians and technicians specially trained in their use and 43 Ibid, p. 77.
44 Swayampakula AK, Dillis C and Abraham J. 2008. Role of MRI in screening, diagnosis and management of breast cancer. Expert Rev Anticancer Ther. 8(5);811-817.
45 National Cancer Institute. 2011. Fact Sheet: Mammograms. Available at: Accessed on February 24, 2011.
46 Connecticut Department of Public Health. 2001. Connecticut Women's Health. P. 67. Available at: . Accessed on February 24, 2011.
47 National Cancer Institute. 2011. Fact Sheet: Mammograms. Av ccessed on February 24, 2011.
48 Ibid.
49 American Cancer Society. 2010. Mammograms and other imaging procedures. Available at: Accessed on February 24, 2011.
Chapter 2. Breast MRI Chapter 2. Breast MRI Screening Recommendations
Mammography, coupled with regular clinical breast exams, is the primary screening method recommended
by the National Cancer Institute,52 the CDC,53 and the American Cancer Society54 to detect cancer in the
breast. However, both the American Cancer Society and the American College of Radiology recommend
the use of MRIs as an adjunct to mammograms for the screening of women at very high risk for developing
breast cancer. It is felt that this level risk of breast cancer outweighs the higher risk of false positives that
MRI entails for such women.
American Cancer Society (ACS) guidelines for breast MRI.55
Annual MRI screening in addition to annual mammogram screening is recommended for women at high risk of developing breast cancer. These are women who: – Have a known BRCA gene mutation, – Are a first degree relative of a known BRCA carrier, but have themselves not been tested, – Have a life-time risk equal to 20-25 percent or greater of developing breast cancer, as defined by BRCAPRO or other models that are largely dependent on family history, – Have had radiation to the chest between the ages of 10 and 30 years, – Have Li-Fraumeni syndrome or are a first degree relative, or – Have Cowden and Bannayan-Riley-Ruvalcaba syndromes or are a first degree relative The ACS has found insufficient evidence to recommend for or against MRI screening for women who have a moderate risk of developing breast cancer. These are women who: – Have a lifetime risk between 15 and 20 percent, as defined by BRCAPRO or other models largely dependent on family history, – Have had lobular carcinoma in situ (LCIS) or atypical lobular hyperplasia (ALH), – Have had atypical ductal hyperplasia (ADH), – Have heterogeneously or extremely dense breast on mammography, or – Have a personal history of breast cancer, including ductal carcinoma in situ (DCIS) – ACS recommends against MRI screening for women at average risk (less than 15 percent lifetime risk) of developing breast cancer.
American College of Radiology (ACR) guidelines for breast MRI.56
ACR recommends MRI as an adjunct to clinical history, physical examination results and the results of
51 Ibid.
52 National Cancer Institute. 2011. Fact Sheet: Mammograms. Available at: Accessed on February 24, 2011.
53 Centers for Disease Control and Prevention. 2011. Breast Cancer Screening. Available at: Accessed on February 24, 2011.
54 Smith R, Cokkinides V and Brawley O. 2009. Cancer screening in the United States, 2009: a review of current American Cancer Society guidelines and issues in cancer screening. CA Cancer J Clin 59(1);27-41.
55 Saslow D, Boetes C, Burke W et al. 2007. American Cancer Society Guidelines for Breast Screening with MRI as an Adjunct to Mammography. CA Cancer J Clin 57(1);75-89. Downloaded from caonline.americancancersoc.org on February 9, 2011.
56 American College of Radiology. 2008. ACR Practice Guideline for the Performance of Contrast-Enhanced Magnetic Resonance Imaging (MRI) of the Breast. Available at: . Accessed on February 24, 2011.
Chapter 2. Breast MRI Chapter 2. Breast MRI mammography for screening high risk patients: – Those with a 20 percent lifetime risk of cancer, – A genetic predisposition to breast cancer based either on genetic testing or family history, or – A history of mantle radiation for Hodgkin's disease.
– ACR recommends using MRI to screen the other breast for cancer when a new breast malignancy has been found in one breast.
– ACR also recommends using MRI for patients with silicone or saline implants, or free injections of silicone or other materials, for whom mammography is difficult. MRI can also be used to determine the integrity of implants.
– ACR does not recommend using MRI to screen for breast cancer in the general population of asymptomatic, average-risk women. – ACR recommends that screening MRI be used in addition to and not in place of screening mammography, because some cancers are detected better by mammography than by MRI. It also recommends that MRI not be used in lieu of biopsy to evaluate suspicious findings of mammography, clinical exam or sonography.
III. Methods
Under the direction of CPHHP, medical librarians at the Lyman Maynard Stowe Library at the University of Connecticut Health Center (UCHC) gathered published articles and other information related to medical, social, economic, and financial aspects of the proposed mandated benefit. Medical librarians conducted literature searches using UptoDate, DynaMed, Cochrane Database, EMedicine and web searches using Google and Bing. General search terms used included MRI, magnetic resonance imaging, screening, breast cancer and breast neoplasm. CPHHP staff conducted independent literature searches using similar search terms used by the UCHC medical librarians. Where available, articles published in peer-reviewed journals are cited to support the analysis. Other sources of information may also be cited in the absence of peer-reviewed journal articles. Content from such sources may or may not be based on scientific evidence. CPHHP staff consulted with clinical faculty from the University of Connecticut School of Medicine on matters pertaining to medical standards of care, traditional, current and emerging practices, and evidence-based medicine related to the benefit. Staff gathered additional information through telephone and e-mail inquiries to appropriate state, federal, municipal, and non-profit entities and from internet sources such as the State of Connecticut website, Centers for Medicare and Medicaid (CMS) website, other states' websites, professional organizations' websites, and non-profit and community-based organization websites.
With the assistance of the Connecticut Insurance Department (CID), CPHHP and Ingenix Consulting surveyed the insurance companies and MCOs domiciled in Connecticut as to whether their fully-insured group and individual plans currently included the proposed mandated benefit. Five insurers/MCOs responded. Three insurers/MCOs also provided information about coverage for this service in the self-insured plans they administer.
CPHHP and the CID contracted with Ingenix Consulting (IC) to provide actuarial and economic analyses of the proposed mandated benefit. Further details regarding the actuarial methods used to estimate the cost Chapter 2. Breast MRI Chapter 2. Breast MRI of the benefit and may be found in the IC report, which is attached as Appendix III. IV. Social Impact
1. The extent to which the treatment, service or equipment, supplies or drugs, as applicable, is
utilized by a significant portion of the population.
Connecticut has approximately 628,717 women between the ages of 40-64, and approximately 127,176 women between the ages of 35-59. Roughly 46.6 percent of Connecticut's population is covered by fully insured group and individual health policies.57 . About 40 percent of women nationally have dense breast tissue, which decreases with age.58 An estimated 2 percent of women are at high risk of developing breast cancer due to genetic or family history of breast cancer.59 2. The extent to which the treatment, service or equipment, supplies or drugs, as applicable, is
available to the population, including, but not limited to, coverage under Medicare, or through
public programs administered by charities, public schools, the Department of Public Health,
municipal health departments or health districts or the Department of Social Services.
Medicare
Medicare distinguishes between screening mammograms given to a person without signs or symptoms of
breast disease, and diagnostic mammograms performed subsequent to a suspicious screening mammogram
or when there are signs or symptoms of disease. Medicare covers one screening mammogram per year for all
women age 40 and over, and one baseline mammogram between the ages of 35-39. Medicare does not cover
screening mammograms for men or for women under 35. A screening mammogram is not subject to the
Part B deductible but is subject to coinsurance. Diagnostic mammograms are also covered, and are subject
to the deductible.
Medicare covers breast MRIs only for the following purposes: – Where diagnosis is inconclusive, – To evaluate post-operative patients when scar tissue cannot be differentiated from tumors, – Where there are positive axillary nodes with no known primary site, – Where there is a rupture of a breast implant, or – To determine the extent of a known malignancy prior to treatment.60 – Medicare does not cover screening MRIs.
Medicaid
Medicaid coverage of MRIs for breast cancer screening closely parallels the coverage provided by Medicare.
Connecticut Department of Public Health
57 University of Connecticut, Center for Public Health and Health Policy. 2009. Review and Evaluation of Public Act 09-188, An Act Concerning Wellness Programs and Expansion of Health Insurance Coverage. Available at: 58 Ingenix Consulting Report, Appendix III, p. 6.
59 National Cancer Institute. 2009. Fact Sheet: BRCA1 and BRCA2: Cancer Risk and Genetic Testing. Available at: Accessed on February 24, 2011.
60 Centers for Medicare and Medicaid Services. 2008. Local Coverage Determination for BREAST Imaging, Connecticut. LCD ID number: L26890. Available at Accessed on February 20, 2011.
Chapter 2. Breast MRI Chapter 2. Breast MRI The Connecticut Department of Public Health funds the Breast and Cervical Cancer Early Detection Program, which provides breast and cervical cancer screening services for certain women between 40 and 65 years of age who are at or below 200 percent of the federal poverty level.61 This program provides, among other services, screening and diagnostic mammograms and breast ultrasounds through contracted health providers around the state. No information was found that would indicate the state Department of Public Health provides services for MRI breast cancer screenings.
3. The extent to which insurance coverage is already available for the treatment, service or
equipment, supplies or drugs, as applicable.
Survey responses from five Connecticut-domiciled insurers/MCOs indicate that 100 percent of fully insured health benefit policies currently provide coverage for screening breast MRI based on medical necessity. One insurer/MCO limits coverage of screening MRIs to the circumstances recommended in the American Cancer Society guidelines. One insurer/MCO allows screening MRIs in accordance with the ACS guidelines and in addition covers screening MRIs for women with a personal history of breast cancer and women with dense breasts. The other three insurers/MCOs did not indicate any limits on the coverage of screening MRIs.
4. If the coverage is not generally available, the extent to which such lack of coverage results in
persons being unable to obtain necessary health care treatment.
Breast MRIs can cost as much as $2,000.62 If insurance coverage is not available, this cost may deter women from obtaining MRIs for cancer screening purposes. For women at high risk of developing breast cancer, for whom a screening MRI is recommended as an adjunct to a screening mammogram, this cost could result in the inability to obtain such screening.
5. If the coverage is not generally available, the extent to which such a lack of coverage results in
unreasonable financial hardships on those persons needing treatment.
Assuming an average annual cost of $2,000,63 the cost of a screening breast MRI can cost an average of 4 percent of a family's income for families earning $50,000 annually, if there is no insurance for it.
6. The level of public demand and the level of demand from providers for the treatment, service or
equipment, supplies or drugs, as applicable.
With the exception of women who are at very high risk for breast cancer (greater than 20-25 percent risk), neither the American Cancer Society nor the American College of Radiologists recommends that MRI be used routinely for breast cancer screening.
7. The level of public demand and the level of demand from providers for insurance coverage for the
treatment, service or equipment, supplies or drugs, as applicable.
The Connecticut State Medical Society and the Radiological Society of Connecticut testified in favor of SB259 in 2010.
8. The likelihood of achieving the objectives of meeting a consumer need as evidenced by the
experience of other states.
Forty-nine states and the District of Columbia mandate insurance coverage of screening mammograms. 61 Connecticut Department of Public Health. 2010. The Connecticut Breast and Cervical Cancer Early Detection Program. Available at: . Accessed on February 21, 2011.
62 Ingenix Consulting Report, Appendix III, p.1763 Ingenix Consulting Report. Appendix III, p. 17 Chapter 2. Breast MRI Chapter 2. Breast MRI According to the National Association of Insurance Commissioners, none of them mandate coverage of breast MRIs.64 9. The relevant findings of state agencies or other appropriate public organizations relating to the
social impact of the mandated health benefit.
The Connecticut Department of Public Health does not include breast MRI in its Breast and Cervical Cancer Early Detection Program.
10. The alternatives to meeting the identified need, including but not limited to, other treatments,
methods or procedures.
Mammography and ultrasound are alternative breast cancer screening technologies. Both are effective in detecting breast lesions in the majority of women, and are widely accepted in the medical community. However, they are less effective than MRIs in detecting certain types of cancers and in detecting cancers in women with dense breast tissue.65 11. Whether the benefit is a medical or broader social need and whether it is consistent with the role
of health insurance and the concept of managed care.
The proposed mandate deals with a technology for the diagnosis of breast cancer, which is a medical disease. It therefore addresses a medical need and is consistent with the role of health insurance and the concept of managed care.
12. The potential social implications of the coverage with respect to the direct or specific creation of a
comparable mandated benefit for similar diseases, illnesses, or conditions.
This mandate may have implications for other types of screening technologies that are new and that are recommended primarily for special patient populations. 13. The impact of the benefit on the availability of other benefits currently offered.
As insurance costs rise, employers may choose to reduce benefit levels rather than drop coverage altogether.
This can be done by increasing member cost-sharing through higher deductible or increased co-pays and/
or coinsurance levels. When this happens, members sometimes forgo needed services because of the out-of-
pocket cost. As a result of the Affordable Care Act, deductibles and co-pays would not be applicable to this
proposed mandated benefit, but the additional cost could cause an increase in member cost for other covered
services that are not preventive in nature. For further discussion, see the IC report at page 24.
14. The impact of the benefit as it relates to employers shifting to self-insured plans and the extent to
which the benefit is currently being offered by employers with self-insured plans.
Five insurers/MCOs domiciled in Connecticut submitted responses to our survey. Three of the five insurers/MCOs indicated that 100 percent of their self-funded policies provide coverage for breast MRIs, presumably with the same medical necessity requirements as their fully insured plans. In general, these medical necessity requirements follow the guidelines of the American Cancer Society. The remaining carriers replied that they could not estimate how many self-funded plans provided such coverage. 15. The impact of making the benefit applicable to the state employee health insurance or health
64 National Association of Insurance Commissioners. 2009. Compendium of State Laws on Insurance Topics.
65 Saslow D, Boetes C, Burke W et al. 2007. American Cancer Society Guidelines for Breast Screening with MRI as an Adjunct to Mammography. CA Cancer J Clin 57(1);84. Downloaded from caonline.americancancersoc.org on February 9, 2011 Chapter 2. Breast MRI Chapter 2. Breast MRI Assuming that the State plans would comply with this proposed mandated health benefit, the total annual cost for this mandate in 2011 is estimated to be $1,814,247.66 This estimate includes both active employees and those retirees who are not covered by Medicare (n.b., the cost may be somewhat lower for the retiree plans, since the density of breast tissue decreases with age and therefore the fewer women will meet the requirements of the mandate). This has been calculated by multiplying the 2011 PMPM cost by 12 to get an annual cost per insured life, and then multiplying that product by 133,334 covered lives for the active employee plans and 30,000 covered lives under the retiree medical plans that are not eligible for Medicare, as reported by the State Comptroller's office.67 Caveat: This estimate is calculated using weighted averages for all claims paid by Connecticut-domiciled
insurers and managed care organizations in the State. The actual cost of this proposed mandate to the State
plans may be higher or lower, based on the actual benefit design of the State plans and the demographics of
the covered lives (e.g., level of cost-sharing, average age of members, etc.).
Retention costs are not included in this estimate because the State is now self-funded and the traditional elements of retention do not apply. State costs for administration of the plans would be in addition to the above amount 16. The extent to which credible scientific evidence published in peer-reviewed medical literature
generally recognized by the relevant medical community determines the treatment, service or
equipment, supplies or drugs, as applicable, to be safe and effective.
Magnetic resonance imaging has become widely used in the United States. Magnetic fields are generally considered to be nonhazardous to the human body, but precautions must be taken to prevent injuries from ferromagnetic objects that may be within the range of the magnet.68 V. Financial Impact
1. The extent to which the mandated health benefit may increase or decrease the cost of the
treatment, service or equipment, supplies or drugs, as applicable, over the next five years
The use of magnetic resonance imaging for breast cancer screening nearly doubled between 2006 and 2008 in Connecticut, with a concomitant doubling in allowed and paid medical costs.69 The IC actuarial report estimates that it is likely to double again over the next five years, as a result of this mandate and the Affordable Care Act's prohibition on patient cost-sharing for preventive services.70 The IC actuarial report estimates that this mandate will double the 2011 estimated medical costs for screening breast MRIs, adding $0.92 PMPM to the estimated 2011 medical cost for this service. By 2015, the mandate will increase the 2011 estimated medical cost for screening breast MRIs by an estimated $1.61 PMPM. This assumes a 5 percent annual increase for medical inflation and a 10 percent annual increase in utilization.71 2. The extent to which the mandated health benefit may increase the appropriate or inappropriate
use of the treatment, service or equipment, supplies or drugs, as applicable, over the next five
66 Ingenix Consulting Report, Appendix 4. Appendix III67 Conversation with Scott Anderson, State Comptroller's office, September 14, 201068 Schenck JF. 2000. Safety of strong, static magnetic fields. Journal of Magnetic Resonance Imaging. 12(1);2-19.
69 Ingenix Consulting Report, Appendix III, pp.6 and 3270 Ibid.
71 Ingenix Consulting Report, Appendix III, p. 36 Chapter 2. Breast MRI Chapter 2. Breast MRI The IC actuarial report estimates that this mandate would double the use of screening breast MRIs initially and would increase the use of screening breast MRIs by 10 percent annually thereafter over the next five years.
3. The extent to which the mandated health benefit may serve as an alternative for more expensive
or less expensive treatment, service or equipment, supplies or drugs, as applicable.
Breast MRI is not viewed as an alternative to mammography and breast ultrasound, but as an adjunct to these screening technologies. The cost of a mammogram is approximately $100-200, and the cost of a sonogram is approximately $100. The cost of a breast MRI is approximately $2,000.72 4. The methods that will be implemented to manage the utilization and costs of the mandated health
The proposed mandate is limited to breast MRI that is prescribed by a licensed health care provider. It is also limited as to the circumstances under which it may apply. In addition, all other terms of the policy apply, so that insurers/MCOs can negotiate allowed costs with MRI providers to help control unit costs and utilization review can be exercised by the carriers to avoid inappropriate use of the benefit. However, the proposed limits are less restrictive than the American Cancer Society guidelines and the current policies of some of the insurers/MCOs. The language of the proposed mandate may also hinder the efforts of the insurers/MCOs to exercise utilization review.
5. The extent to which insurance coverage for the treatment, service or equipment, supplies or drugs,
as applicable, may be reasonably expected to increase or decrease the insurance premiums and
administrative expenses for policyholders.
Insurance premiums include medical cost and retention costs. Medical cost accounts for medical services. Retention costs include administrative cost and profit (for for-profit insurers/MCOs) or contribution to surplus (for not-for-profit insurers/MCOs). (For further discussion, please see Appendix III, Ingenix Consulting Actuarial Report, page 10.) Since the majority of Connecticut insurers/MCOs reported that they currently cover at least some level of screening breast MRIs in their fully insured policies, the figures below represent the estimated incremental cost that would be added to premiums by this mandate, over and above the current cost of breast MRIs that are embedded in current premiums. Thus the figures below do not represent the full estimated cost of benefits for screening breast MRIs in fully insured policies. (The IC actuarial report estimates the current medical cost of screening breast MRIs in group policies to be $0.92 PMPM on a 2011 basis. The PMPM figures below would be in addition to this amount.) Group plans: When the medical cost of the proposed mandate is spread to all insureds in group plans, the
medical costs of the mandate are estimated to be $0.92 PMPM and retention costs are estimated to be $0.18
PMPM on a 2011 basis. Thus the total effect on insurance premiums is estimated at $1.10 PMPM on a
2011 basis, which is 0.3 percent of premium.
Individual plans: When the medical cost of the proposed mandate is spread to all insureds in individual
plans, the medical costs of the mandate are estimated to be $0.62 PMPM and retention costs are estimated
to be $0.19 PMPM on a 2011 basis. Thus the total effect on insurance premiums is estimated at $0.80
PMPM on a 2011 basis, which is 0.3 percent of premium.
72 Ingenix Consulting Report, Appendix III, p. 17 Chapter 2. Breast MRI Chapter 2. Breast MRI For further information, please see Appendix III: Ingenix Consulting Actuarial Report.
6. The extent to which the treatment, service or equipment, supplies or drugs, as applicable, is
more or less expensive than an existing treatment, service or equipment, supplies or drugs, as
applicable, that is determined to be equally safe and effective by credible scientific evidence
published in peer-reviewed medical literature generally recognized by the relevant medical
community.
MRI ($2000) is considerably more expensive than either mammography ($100-200) or ultrasound ($100). All three technologies are deemed to be safe and effective. MRI can detect some cancers, especially in dense breast tissue, somewhat better, but it also has a higher incidence of false positives which can lead to unnecessary follow-up procedures and biopsies.73 7. The impact of insurance coverage for the treatment, service or equipment, supplies or drugs, as
applicable, on the total cost of health care, including potential benefits or savings to insurers
and employers resulting from prevention or early detection of disease or illness related to such
coverage.
The total cost of health care is understood to be the funds flowing into the medical system, which are the medical costs portion of insurance premiums and the cost sharing of the insureds. The Ingenix Consulting actuarial analysis estimates an impact on a 2011 basis of $14,756,010 for coverage of screening breast MRIs for Connecticut residents covered by fully-insured group and individual health insurance. The cost of such MRIs may be offset by lower treatment costs for breast cancers that are found at an earlier stage.
8. The impact of the mandated health care benefit on the cost of health care for small employers, as
defined in section 38a-564 of the general statutes, and for employers other than small employers.
According to the actuarial report, this proposed mandate is expected to have roughly the same effect on the allowed cost of small group plans as it does on large group plans.74 However, the small group market is more sensitive to the cost of health insurance and may be somewhat more likely to drop coverage as a result of cost increases generally. Ingenix also found that small groups tend to shift more cost to the insured in the form of higher co-pays, deductibles, and coinsurance, and to require employees to pay a larger share of the premium than large plans do. Therefore, the cost burden of the mandates is likely to be somewhat greater for those whose insurance is provided through a small group employer. 9. The impact of the mandated health benefit on cost-shifting between private and public payers of
health care coverage and on the overall cost of the health care delivery system in the state.
The estimated annual impact of this proposed mandate on the overall cost of health care delivery in the state is $17,834,328.75 It is not expected to result in cost-shifting between private and public payers of health care coverage. This estimated impact assumes that the State of Connecticut plans continue to comply with this mandate even though these plans are now self-funded and therefore are not required to include it.
73 Saslow D, Boetes C, Burke W et al. 2007. American Cancer Society Guidelines for Breast Screening with MRI as an Adjunct to Mammography. CA Cancer J Clin 57(1);75-89. Downloaded from caonline.americancancersoc.org on February 9, 2011 74 Ingenix Consulting report, Appendix III, p. 2275 Ingenix Consulting report, Appendix III Chapter 3
Parkinson's Disease and Multiple Sclerosis:
Routine Patient Care Costs for Clinical Trials
and Off-Label Drug Prescriptions
Review and Evaluation of Connecticut 2010 General Assembly Senate Bill 260, File No. 247 An Act Concerning Health Insurance Coverage for Routine Patient Care Costs for Certain Clinical Trial Patients Brian L. Benson, MPP Mary U. Eberle, JD University of Connecticut Center for Public Health and Health Policy Chapter 3. Table of Contents
II. Background .40 Table 3.1. Commonly Used FDA-approved Drugs for Parkinson's Disease .46 Table 3.2. Commonly Used FDA-approved Drugs for Multiple Sclerosis .47 IV. Social Impact.49 Table 3.3 States with Statutes for Off-label Prescriptions Not Tied to Specific Diseases or Conditions .55 V. Financial Impact.60 Chapter 3. Clinical Trials Chapter 3. Clinical Trials I. Overview
On July 22, 2010, the Chairs of the Insurance and Real Estate Committee of the Connecticut General
Assembly (the Committee) directed the Connecticut Insurance Department to review the proposed health
benefits contained in Senate Bill 260, File 247, from the 2010 General Assembly session, entitled, "An Act
concerning HeAltH insurAnce coverAge for routine PAtient cAre costs for certAin clinicAl triAl
PAtients." This review follows the requirements stipulated under Public Act 09-179. Reviews of required
health insurance benefits are a collaborative effort of Connecticut Insurance Department and the University
of Connecticut Center for Public Health and Health Policy (CPHHP).
The analysis is based on Senate Bill 260, File Number 247, of the 2010 General Assembly session (SB260), which would amend CGSA § 38a-504a-g; CGSA § 38a-542a-g; CGSA § 38a-492b; and CGSA § 38a-518b to require fully insured group plans and individual insurance policies to cover routine costs of clinical trials for Parkinson's Disease and multiple sclerosis, as well as cancer, and for those plans that cover prescription drugs, it would also require coverage of off-label prescription drugs for Parkinson's Disease and multiple sclerosis. The full text SB260 is attached to this report as Appendix II. As directed by the Committee, this review includes analysis of the social and financial impact of required coverage for benefits associated with Parkinson's disease (PD) and multiple sclerosis (MS). Coverage of routine patient care costs for persons enrolled in cancer clinical trials and off-label drug prescriptions for cancer patients is existing law in Connecticut and analyses of the social and financial impact of required coverage for these benefits was completed in January 2011.76 For off-label drug prescriptions for Parkinson's disease and multiple sclerosis, the proposed health benefit would require coverage only for off-label use of MS-approved drugs for treatment of Parkinson's disease and off-label use of Parkinson's disease-approved drugs for treatment of MS rather than all off-label prescriptions.
In January 2011, CPHHP requested information related to the proposed benefit from seven insurers and managed care organizations (MCOs) domiciled in Connecticut that cover approximately 90 percent of the population in fully-insured group and individual health insurance plans in Connecticut (1.25 million persons). The insurers/MCOs were unable to differentiate claims for routine patient care costs associated with Parkinson's disease and Multiple Sclerosis clinical trials from claims for patient care costs for care not associated with a clinical trial in their claims databases. The insurers/MCOs report that routine patient care costs are generally covered for patients enrolled in clinical trials, consistent with standards of care. For off-label prescriptions, insurers/MCOs stated in general that claims for such services are covered in most circumstances in accordance with common managed care practices used for pharmacy benefits. Some prescription drugs require prior authorization. Additionally, the insurers/MCOs state a patient's diagnosis is not included in claims for prescription drugs thus information technology systems in place for pharmacy benefits cannot be used to identify off-label prescriptions.
Premium impact
CID contracted with Ingenix Consulting (IC) for actuarial and economic analysis of the proposed health
benefits. IC analysis estimates that the costs to both fully insured group plans and individual health
insurance policies for both off-label prescriptions of MS and PD prescription drugs and the routine patient
care costs of clinical trials for PD or MS would be de minimis.
76 Center for Public Health and Health Policy. 2011. Connecticut Mandated Health Insurance Benefits Reviews, 2010. University of Connecticut. Av Accessed February 18, 2011. Chapter 3. Clinical Trials Chapter 3. Clinical Trials Self funded plans
For the same reasons insurers/MCOs were unable to provide claims data for fully insured plans and
individual policies, they were unable to provide information regarding coverage of the services included in
the proposed health benefit for the self-funded plans for which they administer benefits.
This report is intended to be read in conjunction with the Ingenix Consulting Actuarial Report which is included as Appendix III. Parkinson's Disease
Parkinson's disease (PD) is a slowly progressing, degenerative disease that is characterized by a chemical
imbalance in the brain that leads to tremors and difficulty with walking, movement, and coordination.77
The disease is chronic and progressive and is primarily contracted based on heredity.78 The primary
symptoms of PD include the following:79
– Rigidity - stiffness when the arm, leg, or neck is moved back and forth.
– Resting tremor - tremor (involuntary movement from contracting muscles) that is most prominent at rest.
– Bradykinesia - slowness in initiating movement.
– Loss of postural reflexes - poor posture and balance that may cause falls; gait or balance PD occurs when nerve cells in the brain that produce dopamine are slowly destroyed. Dopamine is a neurotransmitter that helps to relay brain signals to the rest of the body. The loss of dopamine leads to loss of muscle function. The cause of deteriorating nerve cells in PD is unknown; however, research suggests specific genetic mutations likely play a role either by genetic inheritance or environmental exposure.80 PD is a form of Parkinsonism. Like PD, Parkinsonism is characterized by symptoms commonly associated with PD including tremors, changes in movement, rigidity, and postural instability. The primary difference is that the cause of Parkinsonism is not related to dopamine. Parkinsonism may be caused by, but not limited to, environmental factors, metabolic disorders, and non-neurological disorders.81 Diagnosis of PD requires a complete neurological exam in conjunction with a review of the patient's medical history. Accurate diagnosis largely depends on the skill of the physician performing the evaluation. Some laboratory and diagnostic tests may be used to rule out other possible conditions; however a physician may need to observe the patient over time to determine presence of PD symptoms.82 The five stages of PD as it progresses throughout the life of a diagnosis are: 83,84 77 National Institutes of Health. 2010. US National Library of Medicine. Parkinson's Disease. Available at: Accessed February 15, 2011.
78 NY Presbyterian Hospital. 2010. Parkinson's disease. Av. Accessed January 31, 2011.
79 Ibid.
80 Bekris LM, Mata IF, Zabetian CP. 2010. The genetics of Parkinson disease. Journal of Geriatric Psychiatry and Neurology 23(4): 228-42.
81 Tuite PJ, Krawczewski K. 2007. Parkinsonism: a review-of-systems approach to diagnosis. Seminars in Neurology 27(2): 113-22.
82 Mayo Clinic Staff. Parkinson's Disease. May Clinic. Available at: Accessed February 15, 2011. 83 Glass J. 2010. The five stages of Parkinson's Disease. Web MD. Av Accessed February 15, 2011.
84 Massachusetts General Hospital. Unified Parkinson's Disease Rating Scale. Available at: Accessed February 15, 2011.
Chapter 3. Clinical Trials Chapter 3. Clinical Trials • Stage One: Mild symptoms, inconvenience completing day-to-day tasks, poor posture, and loss of
• Stage Two: Symptoms are bilateral affecting limbs on both sides of the body, problems walking.
• Stage Three: Severe symptoms, inability to walk straight or stand straight, noticeable slowing of
physical activity.
• Stage Four: Patients cannot live on their own, rigidity and bradykinesia are visible, usually unable to
complete day-to-day tasks.
• Stage Five: Unable to take care of him or herself and may not be able to stand or walk; usually
requires constant one-on-one nursing care.
Approximately 1.5 million people in the United States have Parkinson's disease and 50,000 new cases are diagnosed each year in the United States.85 While onset typically occurs after age 50 and most diagnoses occur around age 60, onset occurs in some patients under age 40.86 Parkinson's disease ranks among the most common late-life neurodegenerative diseases, affecting approximately 1.5 to 2.0 percent of the population older than age 60 years.87 A study of Medicare beneficiaries over a 10-year span determined that whites have a higher prevalence and incidence of PD than blacks or Asians and found no relationship between prevalence and urban/rural residency. 88 Prevalence of the disease is highest in the Midwest and Northeast regions.89 Given the prevalence of PD in these regions the likelihood of environmental factors as contributory to the disease is likely.
While there is no cure for PD, several medications are available to treat and manage the disease. Levodopa is the most commonly prescribed and most effective medicine for controlling the symptoms of Parkinson's disease, particularly bradykinesia and rigidity. When released into the brain Levodopa can be converted into dopamine. Other medications are also available that conserve dopamine in the brain or mimic its function. Pharmacological intervention is frequently effective; however fifteen percent of patients are typically unresponsive to prescription drugs. For these individuals, surgical procedures are available.90 Deep brain stimulation may be used to treat PD and is more commonly used for advanced stages of the disease. The procedure involves implanting an electrode within parts of the brain that control movement. The electrode is regulated by a pace-maker like device implanted in the upper chest that is connected through a wire placed under the skin to the electrode. This procedure has proven effectiveness in controlling involuntary movements (dyskinesia) and tremors.91 85 Cleveland Clinic. 2006. Parkinson's Disease, Incidence. Av ccessed February 15, 2011.
86 Ibid.
87 Sweeney S. 2010. Parkinson's disease. Cleveland Clinic Center for Continuing Education. Available at: Accessed February 10, 2011.
88 Wright Willis A, Evanoff BA, Lian M, et al. 2010. Geographic and ethnic variation in Parkinson disease: a population-based study of US Medicare beneficiaries. Neuroepidemiology 34(3): 143-51.
89 Ibid.
90 Cleveland Clinic. 2006. Parkinson's Disease, Medications. Available at: ccessed February 15, 2011.
91 Mayo Clinic Staff. Parkinson's Disease. May Clinic. Available at: Accessed February 15, 2011.
Chapter 3. Clinical Trials Chapter 3. Clinical Trials The direct medical costs of treatment for persons with PD is considerable. A study concluded the annual direct costs were $23,101 per patient with PD versus $11,247 for controls.92 The researchers added $25,326 in indirect costs, and multiplying by 645,000 cases of PD in the United States, projected an annual cost of $23 billion for the United States.93 Multiple Sclerosis
Multiple Sclerosis (MS) is a chronic, sometimes debilitating autoimmune disorder that affects the brain and
spinal cord (central nervous system). The primary characteristic of the disease is the damage to protective
coverings (myelin sheaths) that surround nerve cells. Nerve damage is caused by inflammation that occurs
when the body's immune cells attack the nervous system. Episodes of inflammation can occur along
any area of the brain, optic nerve, and spinal cord.94 Persons diagnosed with MS suffer from a range of
symptoms including numbness in the limbs, paralysis, or loss of vision. Specific symptoms and onset are
unpredictable and vary between individuals.95
The root cause of MS is unknown. Environmental, immunological, and genetic factors are all being explored. MS affects women more than men.96 The overall incidence rate of MS is 3.6 cases per 100,000 person-years in women and 2.0 in men. During the last half of the 20th Century, the female-to-male ratio in MS incidence steadily increased.97 Risk factors linked to MS include vitamin D deficiency, low lifetime UV radiation, and residing in northern climes.98 However, the significance of these factors as a cause of MS requires further analysis. Other risk factors include being female, between the ages of 20 to 40, having a family history of MS, being white, and having other autoimmune or neurological disorders. Those with a family member stricken with MS have a one to three percent chance of contracting the disease.
Diagnosis of MS requires administration of a set of diagnostic tests that require evaluation by a neurologist who specializes in MS. Nearly 10 percent of people diagnosed with MS have some other condition that mimics MS. A neurological exam, magnetic resonance imaging (MRI) screenings, spinal taps, and blood studies may all contribute to a MS diagnosis. Despite the availability of various tests and diagnostic tools, in large part, a correct diagnosis depends on correct interpretation of the results.99 There are four types of MS:100 – Relapsing-remitting MS (RRMS). RRMS is characterized by relapse (flare-ups of symptoms)
followed by remission (periods of recovery). Symptoms may vary from mild to severe, and relapses and remissions may last for days or months. More than 80 percent of people who have MS begin with relapsing-remitting cycles.
– Secondary-progressive MS (SPMS). SPMS often develops in people who have relapsing-
92 Huse DM, Schulman K, Orsini L, et al. 2005. Burden of illness in Parkinson's disease. Movement Disorders 20(11): 1449-54.
93 Ibid.
94 National Institutes of Health. 2010. US National Library of Medicine. Multiple Sclerosis. Available at: . Accessed February 15, 2011.
95 National Multiple Sclerosis Society. 2011. Symptoms of MS. Available at: Accessed January 31, 2011.
96 Mayo Clinic Staff. 2010. Multiple Sclerosis Risk Factors. Mayo Clinic. Available at: Accessed January 31, 2011. Alonso A, Hernan M. 2008. Temporal terns in the incidences of multiple sclerosis: a systematic review. Neurology 71: 129-135.
98 Krokki O, Bloigu R, Reunanen M. 2010.Increaseing incidence of Multiple Sclerosis of women in Northern Finland. Multiple Sclerosis 99 Cleveland Clinic. 2007. Multiple Sclerosis Diagnosis. Available at: Accessed January 31, 2011. 100 Mayo Clinic. 2011. Multiple Sclerosis. Available at: Accessed January 31, 2011.
Chapter 3. Clinical Trials Chapter 3. Clinical Trials remitting MS. In SPMS, relapses and partial recoveries occur, but the disability doesn't fade away between cycles. Instead, it progressively worsens until a steady progression of disability replaces the cycles of attacks. – Primary-progressive MS (PPMS). PPMS progresses slowly and steadily from its onset. There
are no periods of remission and symptoms generally do not decrease in intensity. About 15 percent of people who have MS have PPMS.
– Progressive-relapsing MS (PRMS). In this relatively rare type of MS, people experience both
steadily worsening symptoms and attacks during periods of remission.
There is no cure for MS and treatment is limited. The available primary treatments modify the disease course and treat exacerbations, attacks and flare-ups. Disease-modifying medications are intended for long term management of the disease through retarding the natural course of MS. They do not directly treat exacerbations. There are currently eight disease-modifying agents on the market approved by the FDA: Avonex, Betaseron, Copaxone, Extavia, Gilenya, Novantrone, Rebif, and Tysabri.101 Most of these drugs are used to treat relapsing-remitting MS. Not all of these eight drugs are FDA approved to treat each of the four types of MS discussed above. Corticosteroids are the most common treatment of MS to reduce inflammation that intensifies during a relapse or attack, known as an exacerbation. Several corticosteroids are FDA-approved for treatment of MS exacerbations. Plasmapheresis or plasma exchange is a procedure that mechanically separates blood cells from plasma and is also used to treat MS exacerbations. Plasma exchange is usually limited to cases of severe relapse in patients who are not responding to intravenous steroids and it is not effective for all types of MS.102Progress is being made through the use of stem cell research in reversing the disease's course; however, further randomized trials are needed.103The cost of the treatment can be considerable. Annual prescription drug costs per patient for the disease-modifying agents range from $20,000-$48,000.104,105 Routine Patient Care Costs for Clinical Trial Patients
Clinical trials are research studies that allow physicians and scientists to investigate ways to improve the
health and care of patients through finding better ways to prevent, diagnose, or treat a disease or condition.
A clinical trial is one of the final stages of a long and careful research process to determine whether promising
approaches to prevention, diagnosis, and treatment are safe and effective. For cancer, Parkinson's disease and
MS patients and their families and physicians, decisions on therapy are largely based on what is known about
treatment outcomes for other patients. In general, the most accurate data are derived from the experience of
a large group of patients treated in a standard manner, such as those enrolled in clinical trials.
A vast catalog of clinical trials is currently underway; most clinical trials are investigating cancer and by comparison, relatively few are investigating Parkinson's disease and MS. Investigators are researching many 101 National Multiple Sclerosis Society. 2010. Disease Modifying Drugs Available at: Accessed January 31, 2011.
102 Cortese I, Chaudhry V, So YT, et al. 2011. Evidence-based guideline update: Plasmapheresis in neurologic disorders: Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology 76(3): 294-300.
103 Ballantyne C. 2009. Stem cell therapy helps patients with multiple sclerosis, small study shows. Scientific American. Available at: Accessed January 31, 2011.
104 Personal communication. James O. Donaldson, MD. February 14, 2011.
105 von Schaper E. 2010. Novartis Gilenya MS pill to cost $48,000 per year. Bloomberg. Available at: Accessed February 10, 2011.
Chapter 3. Clinical Trials Chapter 3. Clinical Trials different types of treatments, drugs, prevention strategies, detection methods, and quality of life of patients in attempts to improve prevention of disease, increase rates of survival, improve treatment methods and reduce side effects of treatment. The United States National Institutes of Health currently documents 17,463 cancer clinical trials in the United States; 1060 in Connecticut. There are several different types of clinical trials. Treatment trials test new treatments, e.g., a new drug, new approaches to surgery or radiation therapy, new combinations of treatments, or novel methods. Prevention trials test new approaches, such as medicines, vitamins, minerals, or other supplements that may lower the risk of a disease. Screening trials test the best way to detect disease, especially in its early stages. Quality of Life trials (also called Supportive Care trials) explore ways to improve comfort and quality of life for patients.106 There are also several different phases of clinical trials. Phase I trials test the maximum tolerated dose and side effects of a new drug. Phase I trials also evaluate the frequency and determine how a new drug should be given (by mouth, injected into the blood, or injected into the muscle). A Phase I trial usually enrolls only a small number of patients with advanced disease. Phase II trials continue to test the safety of the drug, and begin to evaluate how well the new drug works and usually focus on a particular type or subtype of disease (e.g., RRMS or melanoma). Phase III trials test a new drug, a new combination of drugs, or a new surgical procedure in comparison to standard therapy to evaluate response to treatment, survival, and quality of life. Phase III trials often enroll 400-1000 people and may be conducted at many doctors' offices, clinics, and hospitals nationwide. A successful Phase III trial results in submission to the Food and Drug Administration (FDA) for approval. Upon FDA approval, the drug or treatment is made available for commercial use in patients with the specifically tested type of disease (e.g., RRMS or breast cancer). Phase IV trials evaluate the side effects, risks, and benefits of a drug over a longer period of time and involve thousands of people—far more than Phase III trials.
While enrolled in a clinical trial, patients continue to receive the routine health care (such as doctor visits, hospital stays, clinical laboratory tests, x-rays, recommended treatment, drugs, etc.) that they would receive whether or not they were participating in a clinical trial. A common clinical trial design is delivery of the investigational treatment in addition to "standard of care" services; often, the "standard of care" services are included in routine health care costs.107 Due to their own financial constraints and the high cost of health care and existing treatments, clinical trial sponsors generally do not cover routine patient care costs for trial participants. Insurance coverage of medically necessary routine patient care costs for persons enrolled in cancer, Parkinson's disease, and MS clinical trials may be a factor in the decision to enroll in a clinical trial, which can affect the survival, health outcome, quality of life and recovery time of patients, and affect the progress of medical research on the whole. Off-label Use of Prescription Drugs
"Off label drug prescription" or off-label use of a drug refers to the use of an FDA-approved drug for a
treatment that is not listed on its FDA-approved label. It does not refer to the use of investigational drugs
that have not yet received FDA approval.108 Off-label use may refer to an approved drug that is:
– Used for a different disease or medical condition, – Given in a different way (such as by a different route), or 106 National Cancer Institute. Clinical Trials. United States National Institutes of Health. Available at: Accessed September 23, 2010.
107 Personal communication. Biree Andemariam, MD. July 14, 2010.
108 National Cancer Institute. 2004. Understanding the Approval Process for New Cancer Treatments. Available at: Accessed on January 8, 2011.
Chapter 3. Clinical Trials Chapter 3. Clinical Trials – Given in a different dose than on the approved label.109 FDA approval is required prior to marketing new drugs. FDA approval is based on the results of clinical trials submitted to the FDA as part of the approval process and is often very narrow in its application. The FDA considers the marketing of an approved drug for unapproved use to be an unapproved new drug with respect to that use [FD&C Act §§ 505(a), 30l(d), 21 U.S.C. 355(a), 33 1(d)], and the marketing of a drug for an unapproved use to be misbranding because the label does not include the new use or adequate directions for the unapproved use.110 The drug manufacturer is not required to seek FDA approval for new uses of an approved drug. It simply may not market or recommend the drug for a use for which it is not approved. The FDA does allow manufacturers to provide reprints of articles from peer-reviewed journals supporting an off-label use of an approved drug in some circumstances, provided the manufacturer does not promote the use of its drug for that off-label use.111 Regardless, the FDA does not regulate the practice of medicine; once a drug is approved by the FDA as safe and effective, a licensed physician may prescribe it for any purpose for which it is deemed to be medically appropriate.112 Drug Compendia
Of the three compendia listed in the proposed health benefit, only the American Society of Hospital
Pharmacists' American Hospital Formulary Service Drug Information (AHFS-DI) is still in existence. The
U. S. Pharmacopoeia Drug Information Guide for the Health Professional (USP DI) and the American
Medical Association's Drug Evaluations (AMA DE) are no longer in use. The content of the U.S.
Pharmacopeia was included in DrugPoints, a successor compendium.113 In 2008 CMS added three new
compendia, Clinical Pharmacology, DRUGDEX, and the National Comprehensive Cancer Network Drugs
and Biologics Compendium, to its list of approved compendia for Medicare.114 CMS requires approved
compendia to have a publicly transparent process for evaluating therapies and for identifying conflicts of
interest. In addition, compendia approved after 2010 must explicitly identify the indications that are not
medically accepted as well as the indications that are medically accepted for a particular drug.115
Prescription Drugs and Off-label Use for Parkinson's Disease
There are several drugs that are FDA-approved and used for treatment of PD. Under the proposed health
benefit, coverage would be required if these drugs were prescribed for use by a person with MS. The off-
label use of an FDA-approved drug for Parkinson's disease in the treatment of MS is expected to be a very
rare occurrence.116
109 American Cancer Society. Off-label Drug Use. Available at: Accessed on January 8, 2011.
110 U.S. Department of Health and Human Services, Food and Drug Administration. 2009. Good reprint practices for the distribution of medical journal articles and medical or scientific reference publications on unapproved new uses of approved drugs and approved or cleared medical devices. Av. Accessed on January 8, 2011.
111 Ibid.
112 American Cancer Society. Off-label Drug Use. Available at: Accessed on January 8, 2011.
113 Abernethy A, Raman G, Balk E, et al. 2009. Systematic review: reliability of compendia methods for off-label oncology indications. Annals of Internal Medicine 150(5):336.
114 Ibid.
115 Centers for Medicare and Medicaid. 2008. Thompson Micromedex Drugdex Compendium Revision Request - CAG00391. Available at: Accessed on January 8, 2011.
116 Personal communication. James Donaldson, MD. Chapter 3. Clinical Trials Chapter 3. Clinical Trials Table 3.1. Commonly Used FDA-approved Drugs for Parkinson's Disease
Generic name/Active ingredient Central nervous system agent + Decaroxylase inhibitor Central nervous system agent + Decaroxylase inhibitor + catechol-O-methyltransferase (COMT) inhibitor Monoamine oxidase (MAO) type B inhibitors Monoamine oxidase (MAO) type B inhibitors The proposed health benefit, as written, does not require coverage for all off-label prescriptions for persons with PD. The off-label use of MS drugs for treatment of Parkinson's disease and the off-label use of Parkinson's disease drugs for treatment of MS is expected to be rare.117 In contrast, several potential Parkinson's treatments are FDA-approved for treatment of conditions other than MS, for example:118 Š Abilify (aripiprazole) – Currently in use as an antipsychotic. In phase IV trial for treating psychosis associated with Parkinson's.
Š Keppra (levetiracetam) – Currently in use as an antiepileptic. In phase IV clinical trial for treatment of levodopa-induced dyskinesia.
Š Zonegran (zonisamide) – Currently in use as an antiepileptic. A phase III study in Japan of its use in Parkinson's found it improved all main Parkinson disease symptoms including tremor and dyskinesias. Approval as a PD treatment is being applied for in Japan.
Š Namenda (memantine hydrochloride) - Currently used for moderate to severe Alzheimer's. In phase IV trial for treatment of cognitive impairment and dementia in Parkinson's Disease.
Š DynaCirc (isradipine) - Currently prescribed for high blood pressure and stroke. Pre-clinical research with mice found it might offer neuroprotection for dopamine neurons. Currently in a phase I trial to determine safety of higher doses.
Š Minocycline – Currently in use as an antibiotic. A phase II futility trial for possible neuroprotective benefits (NET-PD) recommended further study.
Š PD-02 (Creatine) – A dietary supplement used by athletes to improve performance. Since it plays a role in mitochondrial energy production, and there is evidence of mitochondrial dysfunction in Parkinson's disease, it is thought creatine might provide neuroprotection. Currently in a phase III trial.
Prescription Drugs and Off-label Use for Multiple Sclerosis
Currently, eight FDA-approved disease modifying agents are available for MS: Avonex, Betaseron,
117 Ibid.
118 Parkinson Pipeline Project Database. 2007. Questions and answers about "off-label use of prescription drugs. Available at: Accessed February 4, 2010.
Chapter 3. Clinical Trials Chapter 3. Clinical Trials Copaxone, Extavia, Gilenya, Novantrone, Rebif, and Tysabri.119 Most of these drugs are used to treat relapsing-remitting MS. Not all of these eight drugs are FDA-approved to treat each of the four types of MS discussed above and some physicians may prescribe these drugs off-label for patients with less common types of MS. Additionally, there are several drugs used to treat symptoms related to MS. Table 3.2120 lists the drugs on the market that are FDA-approved for treatment of MS and could conceivably be required to be covered for off-label use for persons with Parkinson's disease should the proposed health benefit be enacted.
Table 3.2. Commonly Used FDA-approved Drugs for Multiple Sclerosis
Active ingredient Relapsing forms of MS Interferon beta-1a Relapsing forms of MS Interferon beta-1b Relapsing forms of MS Interferon beta-1b Relapsing-remitting MS Relapsing forms of MS Worsening relapsing-remitting MS, progressive-relapsing MS or secondary-progressive MS Relapsing forms of MS Interferon beta-1a Monotherapy122 for relapsing forms of MS Symptoms Related to MS123
Ampyra®
Walking difficulties associated with MS H.P. Acthar Gel® Acute exacerbations of MS Adrenocorticotropic Hormone /Corticotropin Acute exacerbations of MS Celestone Soluspan® Acute exacerbations of MS Acute exacerbations of MS (generic drug)Lioresal® Spasticity associated with MS 121,122,123 In treating symptoms of MS, physicians may prescribe off-label drugs.124 Naltrexone was approved by the FDA in 1984 for opiate addiction and in 1995 for alcohol abuse. Studies show that low dose Naltrexone 119 National Multiple Sclerosis Society. 2010. Disease Modifying Drugs Available at: Accessed January 31, 2011.
120 There may be other prescription drugs that are FDA-approved for treatment of MS that are not listed.
121 National Multiple Sclerosis Society. 2010. The MS Disease Modifying Medications. General Information. Available at: Accessed February 10, 2011.
122 Monotherapy refers to use of drugs not in combination with any other disease-modifying medications.
123 National Multiple Sclerosis Society. 2010. Medications used in MS. Available at: Accessed February 10, 2011. 124 Multiple Sclerosis Association of America. 2010. MS Symptoms Management. Available at: . Accessed January 31, 2011.
Chapter 3. Clinical Trials Chapter 3. Clinical Trials (LDN) may be an effective treatment for MS. A recent clinical trial found that LDN is a relatively safe therapeutic option in RRMS and SPMS while recommending additional long-term clinical trials.125 Modafinil (brand name, Provigil), is a FDA-approved drug for the treatment of narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift-work sleep disorder, but was found to relieve MS fatigue in some studies. A literature review shows that use of modafinil for the treatment of MS-related fatigue has demonstrated benefit in uncontrolled studies but has conflicting results from two controlled studies.126 In summary, the proposed health benefit, as written, would not require coverage for all drugs prescribed on an off-label basis; it would require coverage of FDA-approved drugs for MS for persons diagnosed with Parkinson's disease and coverage of FDA-approved drugs for PD for persons diagnosed with MS.
III. Methods
Under the direction of CPHHP, medical librarians at the Lyman Maynard Stowe Library at the University of Connecticut Health Center (UCHC) gathered published articles and other information related to medical, social, economic, and financial aspects of the proposed health benefit. Medical librarians conducted literature searches using PubMed, Scopus, UpToDate, DynaMed, Cochrane Database, EMedicine, Micromedex, and a web search using Google and Bing. Search terms included health knowledge, attitudes, practice; health care costs; health care disparities; health insurance; reimbursement; insurance coverage; cost effectiveness analysis; clinical trials, economics, legislation, jurisprudence; Parkinson's disease; Multiple Sclerosis; biomedical research; demography; research support; insurance benefits; off-label; drug labeling; cancer; neoplasm; social impact. CPHHP staff conducted independent literature searches using the Cochrane Review, Scopus, and Google Scholar under the search terms of Parkinson's disease; Multiple Sclerosis; clinical trials; routine patient care costs; and off-label prescription drugs. Where available, articles published in peer-reviewed journals are cited to support the analysis. Other sources of information may also be cited in the absence of peer-reviewed journal articles. Content from such sources may or may not be based on scientific evidence. CPHHP staff consulted with clinical faculty and staff from the University of Connecticut School of Medicine and School of Pharmacy on matters pertaining to medical standards of care; traditional, current and emerging practices; and evidence-based medicine related to the proposed health benefit. Staff gathered additional information through telephone and e-mail inquiries to appropriate state, federal, municipal, and non-profit entities and from internet sources such as the State of Connecticut website, Centers for Medicare and Medicaid Services (CMS) website, other states' websites, professional organizations' websites, and non-profit and community-based organization websites.
CPHHP requested information related to the proposed increase in coverage from seven insurance companies and MCOs domiciled in Connecticut. Insurers/MCOs provided information about current coverage of services included in the proposed health benefit. The insurers/MCOs were unable to provide claims data for off-label prescriptions or for routine patient care costs associated with Parkinson's disease and Multiple Sclerosis clinical trials for their fully insured group and individual plan participants or for the self-insured plans they administer. Claims paid for routine patient care costs for persons enrolled in clinical trials cannot be isolated and claims paid for off-label prescriptions are indistinguishable from claims paid for drugs 125 Sharafaddinzadeh N, Moghtaderi A, Kashipazha D, et al. 2010. The effect of low-dose naltrexone on quality of life of patients with multiple sclerosis: a randomized placebo-controlled trial. Multiple Sclerosis 16(8): 964-9.
126 Brown JN, Howard CA, Kemp DW. 2010. Modafinil for the treatment of multiple sclerosis-related fatigue. The Annals of Pharmacotherapy 44(6):1098-103. Mohamed N. Hassan, MD, PhD. February 18, 2011.
Chapter 3. Clinical Trials Chapter 3. Clinical Trials prescribed as approved by the FDA. CPHHP and the CID contracted with Ingenix Consulting (IC) to provide actuarial and economic analyses of the proposed health benefit. Further details regarding the insurer/MCO information request and actuarial methods used to estimate the cost of the benefit may be found in Appendix III.
IV. Social Impact
1. The extent to which the services included in the proposed health benefit are utilized by a
significant portion of the population.
According to the U.S. National Institutes of Health, 698 clinical trials for MS are underway in the United States; 271 of which are seeking new volunteers. In Connecticut, 47 clinical trials are underway for MS; 12 are seeking new patients. For Parkinson's Disease, 783 clinical trials are underway in the U.S.; 277 are seeking new patients. In Connecticut, 77 clinical trials are underway for Parkinson's Disease; 21 of which are seeking new patients.
An actuarial analysis of existing health insurance mandates in Connecticut estimated that 0.023 percent of all insureds in Connecticut had a diagnosis code for participation in a clinical trial, which would be approximately 320 persons.127 The diagnosis code includes participation in any clinical trial (not specifically a Parkinson's Disease or multiple sclerosis clinical trial). The vast majority of clinical trials occurring in the United States and in Connecticut are related to cancer; there are ten times as many cancer clinical trials underway in Connecticut as there are for PD and MS combined.128 For further information, please see Appendix III, Ingenix Consulting Actuarial Report, page 18.
Off-label drug use is well-documented in the medical literature and very common in certain settings, such as oncology, pediatrics, and HIV/AIDS care. The extent to which off-label drug use of Parkinson's disease drugs for treatment of MS and vice versa occurs is unknown. Due to the low prevalence of Parkinson's disease and MS in the fully-insured group and individual policy population, utilization of off-label prescription drugs as defined in the bill is expected to be low. 2. The extent to which the services included in the proposed health benefit are available to the
population, including, but not limited to, coverage under Medicare, or through public programs
administered by charities, public schools, the Department of Public Health, municipal health
departments or health districts or the Department of Social Services.
Medicare
Routine patient care costs—In 2000, Medicare policy changed to include coverage of routine patient
care costs of clinical trials.129 Medicare pays for routine health care costs for beneficiaries enrolled in most
treatment clinical trials that are funded by federal agencies, including office visits, tests, hospital stays,
surgery, tests and treatments for side effects.130 Medicare does not pay for some clinical trial treatments,
tests that collect information only for the trial, and coinsurance and deductibles.131 The trial must evaluate
127 University of Connecticut Center for Public Health and Health Policy. 2011. Connecticut Mandated Insurance Benefits Reviews, 2010,
Volume IV. Available at: http://www.ct.gov/cid/cwp/view.asp?a=1254&q=447304. Accessed February 10, 2011.
128 National Cancer Institute. 2010. Studies related to cancer in the United States. United States National Institutes of Health. Available at: Accessed September 22, 2010.
129 Unger JM, Coltman CA, Crowley JJ, et al. 2006. Impact of the year 2000 Medicare policy change on older patient enrollment to cancer clinical trials. Journal of Clinical Oncology 24(1): 141-4.
130 U.S. Department of Health Aid and Human Services. 2001. Medicare and Clinical Trials. Available at: . Accessed January 21, 2010.
131 National Cancer Institute. 2009. Clinical trials and insurance coverage. National Institutes of Health. Chapter 3. Clinical Trials Chapter 3. Clinical Trials an item or service that falls within a Medicare benefit category and must be designed to treat or diagnose a disease. No information was found specifically regarding routine patient care costs associated with clinical trials for Parkinson's Disease or multiple sclerosis. Medicare generally covers routine patient care costs of clinical trials funded by one of the following federal agencies: – National Institutes of Health (NIH) – Centers for Disease Control and Prevention (CDC) – Agency for Healthcare Research and Quality (AHRQ), – Health Care Financing Administration (HCFA) – Department of Defense (DOD) – Department of Veterans Affairs (VA).132 Off-label drug prescriptions—Part B: Prior to 1993, Medicare and many commercial insurers did not pay
for drugs prescribed off-label, deeming such use to be experimental or investigational. In 1993, Congress
directed CMS to pay for drugs and biologics for off-label uses if they were included in the same compendia
that are listed in the Connecticut law or were supported by clinical evidence in peer-reviewed medical
literature appearing in publications which have been identified for this purpose by the Secretary.133 It
also empowered the Secretary of Health and Human Services to revise the list of compendia provided the
included compendia have a publicly transparent process for evaluating therapies and for identifying potential
conflicts of interests.
Part D: Medicare contractors are required to provide coverage for accepted off-label uses published in the recognized compendia. However, they have discretion over coverage of off-label uses that are only referenced in peer-reviewed literature.134 To receive coverage for an off-label drug, the beneficiary or provider must submit evidence in support of the prescribed use to the drug plan.135 Public Programs Administered by Charities
The National MS Society does not offer health care insurance, and does not have the means to provide all
the people who need it with financial assistance. Some financial assistance is available to those who qualify.
The MS Society also answers financial and insurance questions from the public and funds research on the
causes of MS and its potential prevention and treatment.136
The National Parkinson's Foundation does not provide direct financial assistance, but does help individuals with Parkinson's Disease with financial planning and with strategies for coping with the disease.137 Available at: Accessed February 7, 2011.
132 Ibid.
133 Social Security Administration. Compilation of Social Security Laws. Part E – Miscellaneous Provisions, Definitions. 42USC sec 1861(t) (2). Av Accessed on January 8, 2011.
134 Centers for Medicaid and Medicare Services: 2010. Medicare Benefit Policy Manual; Chapter 15 Covered medical and other health services. Sec. 50.4.5 Off-label use of drugs and biologicals in anticancer chemotherapeutic regimen. Available at: . Accessed on January 10, 2011.
135 Center for Medicare Advocacy, Medicare Coverage for Off-label Drug Use. Available at: Accessed February 24, 2010.
136 National MS Society. 2010. "Financial Assistance". Available at: Accessed February 7, 2011.
137 National Parkinson Foundation. 2010. About Us. AvAccessed February 7, 2011.
Chapter 3. Clinical Trials Chapter 3. Clinical Trials The Parkinson's and MS charities may also help with transportation and lodging, which are particularly important needs for clinical trials participants and their families. Clinical trials participants often must travel long distances to participate in a specific clinical trial during treatment and for follow-up, thus financial assistance for travel and lodging for patients and their families can offset significant financial burdens not covered by health insurance or the clinical trial sponsor.
The Partnership for Prescription Assistance (PPA) program is organized by drug companies, health care providers, patient advocacy organizations, and community groups. PPA helps people who lack prescription coverage find assistance programs. There are over 475 public and private patient assistance programs, including more than 200 programs offered by drug companies.138 For eligible patients, PPA programs may be available that provide off-label prescription drugs for persons with MS.
Public Programs Administered by Public Schools
No information was found that would indicate Connecticut public schools provide services related to the
proposed health benefit. While some schools may provide the types of routine health care services covered
by the mandate for students, it is unlikely provision of such care occurs for students in clinical trials.
The Department of Public Health (DPH)
No information was found that would indicate the Connecticut Department of Public Health provides
or funds routine patient care costs associated with clinical trials or off-label drug prescriptions for persons
with Parkinson's disease or multiple sclerosis as defined in the bill. A search of the DPH website found no
references to Parkinson's disease or multiple sclerosis.
Municipal Health Departments
No information was found that would indicate Connecticut municipal health departments or health districts
provide or fund services related to the proposed health benefit.
The Department of Social Services (DSS)
Medicaid covers medical services based on medical necessity, thus it is expected that routine patient care
costs associated with multiple sclerosis and Parkinson's disease clinical trials would be covered.
No information was found related to Medicaid off-label drug prescription coverage for persons with Parkinson's disease or multiple sclerosis specifically as defined in the bill. The Social Security Act provides for coverage of off-label drugs in title 19, section 1927(g)(1)(b)(i) and (k)(6). It allows such drugs to be subject to prior authorization and to be excluded from formularies by the states if the excluded drug does not have a clinical advantage over other drugs which are included in the formulary (section 1927(d) and if coverage can be requested under prior authorization.
3. The extent to which insurance coverage is already available for services included in the proposed
The extent to which insurance coverage for the services included in the proposed health benefit is already available is not precisely known because utilization of these services is not easily identified in insurer/MCO data systems. In general, coverage of routine patient care costs associated with clinical trials is a common practice; it is assumed to occur in clinical trials for PD and MS. Not all health insurance plans include pharmacy benefits. Off-label prescription drug use is a common medical practice, however no information specific to off-label prescription drug coverage for Parkinson's disease and multiple sclerosis as limited in the 138 American Cancer Society. 2010. Prescription Drug Assistance Programs. Av . Accessed January 10, 2011.
Chapter 3. Clinical Trials Chapter 3. Clinical Trials proposed bill was found and medical experts assert that there is no clear rationale for use of PD-approved drugs in treatment of MS or for use of MS-approved drugs in treatment of PD.139 4. If the coverage is not generally available, the extent to which such lack of coverage results in
persons being unable to obtain necessary health care treatment.
Lack of coverage for routine patient care costs for persons enrolled in Parkinson's disease and MS clinical trials or for off-label drug prescriptions would not necessarily result in persons being unable to obtain necessary health care treatment. Coverage of standard of care treatment services for Parkinson's disease and MS is expected to be included in most fully insured group plans and individual health insurance policies. Lack of coverage for off-label prescriptions and routine patient care costs associated with clinical trials may limit access to the full range of desired health care treatment options for some persons with Parkinson's disease or MS who are interested in enrolling in clinical trials or utilizing certain prescriptions not approved for the disease or condition that afflicts them. The uninsured and underinsured represent the largest population groups in Connecticut that may be unable to obtain necessary health care treatment. While Connecticut residents who are uninsured and underinsured may obtain treatment through the health care safety net or from providers on a no- or low- cost basis, they may be more likely receive a delayed diagnosis and require more intensive treatment because the disease may have progressed further than for an individual with health insurance coverage.
5. If the coverage is not generally available, the extent to which such a lack of coverage results in
unreasonable financial hardships on those persons needing treatment.
There is a range of costs for routine patient care costs associated with Parkinson's disease and Multiple Sclerosis clinical trials; several factors contribute such as the type of clinical trial, type and severity of potential side effects of treatment and location of facility. Prescription drugs can be high cost medical expenses in general; prescription drugs for treatment of MS are generally high cost; $20,000-$40,000 per year.140 The retail cost of a recently approved brand-name drug for treatment of MS is reported to be $48,000 annually.141 Financial hardships may be experienced due to routine patient care costs or prescription drugs for those without insurance coverage for the proposed health benefits. Depending on the severity of disease and progression at time of diagnosis, a diagnosis of Parkinson's disease or Multiple Sclerosis often results in significant health and economic costs for the individual and their family, even for those with comprehensive health benefits. In such cases, lost work time and income are common, as well as other costs associated with treatment (e.g., travel) that are not covered by health insurance. In clinical trials, the costs of the treatment under investigation do not generally result in financial hardships for the patient or their families because investigational treatments are provided free-of-charge by the sponsoring organization or with minimal cost to the participant/patient. 6. The level of public demand and the level of demand from providers for services included in the
proposed health benefit.
Routine patient care costs of clinical trials—Because clinical trials may provide patients with debilitating
diseases/conditions unique opportunities for finding effective treatment, it is expected that the proposed
139 Personal communication. James Donaldson, MD; and Mohamed N. Hassan, MD, PhD. February 18, 2011.
140 Personal communication. James Donaldson, MD.
141 von Schaper E. 2010. Novartis Gilenya MS pill to cost $48,000 per year. Bloomberg. Available at: Accessed February 10, 2011.
Chapter 3. Clinical Trials Chapter 3. Clinical Trials benefit might enjoy broad public and provider support. However, public demand is tempered due to lack of awareness of the availability of clinical trials and widespread misconceptions about clinical trials among lay persons (e.g., fear of getting a placebo instead of actual treatment, being a "guinea pig").142 Provider demand, while assumed to be generally strong due to the scientific background of health care practitioners, may be moderated due to structural barriers in the way the practice of medicine is organized, such as lack of time, staff, or funding to enroll patients and lack of strong connections with research institutions where clinical trials occur. Off-label drug prescriptions—For cancer, approximately half of anti-cancer chemotherapy drugs are
prescribed off-label according to the American Society of Clinical Oncology.143 The percentage of off-label
use of FDA-approved prescription drugs for MS and Parkinson's disease is unknown. It is estimated that
some public and provider demand for coverage of off-label prescriptions for MS and Parkinson's disease is
likely as evidenced by widespread use of the practice in general; no specific studies or information about
public and provider demand for use of FDA-approved MS drugs for treatment of Parkinson's disease or for
use of FDA-approved PD drugs for treatment of MS were found.
7. The level of public demand and the level of demand from providers for insurance coverage for the
services included in the proposed health benefit.
Medicare policy changed in 2000 to include coverage of routine patient care costs associated with clinical trials. It is likely that public and provider demand for Medicare coverage for the benefit contributed to the change in policy. For off-label prescriptions for Parkinson's disease and MS, no information published in peer-reviewed literature was found that would indicate the level of public or provider demand for insurance coverage of the services. For cancer, at least one professional organization advocates for third-party payers to be required to cover off-label indications for anti-cancer drugs if such indications are listed in the compendia or supported in peer-reviewed medical literature.144 Several members of the public and providers testified in favor of insurance coverage for the proposed health benefits during the time the bill was under consideration by the Connecticut General Assembly.145 8. The likelihood of achieving the objectives of meeting a consumer need as evidenced by the
experience of other states.
Routine patient care costs for clinical trials—No information was found regarding other states' coverage
of routine patient care costs related specifically to multiple sclerosis and Parkinson's disease clinical trials.
Different organizations report divergent numbers of states with required coverage of routine patient care
costs related to clinical trials as follows:
The National Cancer Institute (NCI) reports that Washington DC and 25 states including Connecticut require coverage for patient care costs for patients enrolled in cancer clinical trials only.146 The NCI also reports eight states with required coverage for patient care costs for patients in clinical trials for cancer or for 142 National Parkinson's disease and Multiple Sclerosis Institute. 2005. Doctors, patients face different barriers to clinical trials. U.S. National Institutes of Health. Available at: Accessed September 27, 2010.
143 American Society of Clinical Oncology. 2006. Reimbursement for cancer treatment: coverage of off-label drug indications. Journal of Clinical Oncology 24:3206-3208.
144 American Society of Clinical Oncology. ASCO's position. Available at: Accessed on January 8, 2011.
145 Connecticut General Assembly. Joint Favorable Report. An Act concerning HeAltH insurAnce coverAge for routine PAtient cAre costs for clinicAl triAl PAtients. Insurance and Real Estate Committee. SB-260. March 16, 2010.
146 U.S. National Institutes of Health. National Cancer Institute. States That Require Health Plans to Cover Patient Care Costs in Clinical Trials. Available at: http://www.cancer.gov/clinicaltrials/education/laws. Accessed December 1, 2010.
Chapter 3. Clinical Trials Chapter 3. Clinical Trials other life-threatening conditions. It is assumed that routine patient care costs in clinical trials for Parkinson's disease and MS contemplated by the bill under review would be covered in these eight states. The states that do not limit mandated coverage of patient care costs to cancer clinical trials include Colorado, Maine, Maryland, New Hampshire, North Carolina, Oregon, Texas, and West Virginia. Specifically, in Colorado, patient care costs are covered for clinical trials for patients with a disabling, progressive, or life-threatening condition. Maine's statute for patient care costs in clinical trials requires coverage for a life-threatening or serious illness for which no standard treatment is effective. Maryland requires coverage of patient care costs for phase II, III, and IV clinical trials for life threatening conditions for which there are no clearly superior non-investigational alternative. New Hampshire requires coverage for cancer or other life-threatening conditions. North Carolina requires coverage for patients with a life-threatening condition in a Phase II, III, or IV clinical trial. Oregon requires coverage of routine patient care costs in all clinical trials. Texas requires coverage for clinical trials conducted to prevent, detect, or treat a life-threatening condition. West Virginia requires coverage for clinical trials for cancer or treatment of any other life-threatening condition. The National Association of Insurance Commissioners lists eight states, including Connecticut, that require coverage of routine patient care costs for persons enrolled in clinical trials; however, only two states, New Hampshire and West Virginia do not limit coverage to cancer clinical trials.147 The Council for Affordable Health Insurance lists 28 states with insurance mandates for "Clinical Trial(Cancer)" but does not provide information about clinical trials for any other specific diseases/conditions or types of services that must be covered.148 Off-label prescriptions—The National Association of Insurance Commissioners lists 33 states that mandate
insurance coverage for off-label prescription drugs.149 Seventeen states (including Connecticut) limit the
mandated service to cancer treatments. Three states with mandates for cancer treatments also have mandates
for off-label drugs for HIV/AIDS. Sixteen states have insurance mandates for off-label prescriptions that
are not tied to specific diseases or conditions. It is assumed that off-label prescribing for Parkinson's disease
and MS contemplated by the bill under review would be covered in these states. Most states require that
the drug be recognized for the use for which it is prescribed by at least one standard medical reference
compendia or a medically recognized peer-reviewed journal. Only Connecticut and Nevada specify the
compendia to be used. Please see Table 3.3 for further details.
Table 3.3 States with Statutes for Off-label Prescriptions Not Tied to Specific Diseases or
Insurance policy may not exclude coverage on the grounds that the drug is being used for other purposes than approved by the FDA if the drug treatment is recognized in at least one standard reference compendium. Shall not limit or exclude prescription coverage because a drug is prescribed for a different use than approved by the FDA if it meets one of the following conditions: 1) the drug is prescribed for a life threatening condition, 2) the drug is medically necessary to treat a chronic and seriously debilitating condition and the drug is on the insurer's formulary, or 3) the drug usage is recognized by one of the listed standard medical reference compendia.
147 NAIC Compendium of State Laws on Insurance Topics. National Association of Insurance Commissioners. August 2008.
148 Craig Bunce V, Wieske JP. 2010. Health insurance mandates in the states 2010. Council for Affordable Health Insurance. Available at: . Accessed February 10, 2011.
149 NAIC Compendium of State Laws on Insurance Topics. National Association of Insurance Commissioners. August 2008.
Chapter 3. Clinical Trials Chapter 3. Clinical Trials Table 3.3 States with Statutes for Off-label Prescriptions Not Tied to Specific Diseases or
Shall not limit or exclude prescription coverage because a drug is prescribed for a different use than approved by the FDA, if it meets one of the following conditions: 1) the drug is prescribed for a life threatening condition, 2) the drug is medically necessary to treat the condition and the drug is on the insurer's formulary, or 3) the drug usage is recognized by one of the listed standard medical reference compendia.
Insurance policy that includes prescription coverage may not exclude coverage on the grounds that the drug is being used for other purposes than approved by the FDA if the drug treatment is recognized in at least one standard reference compendium or the use is found to be safe and effective in formal clinical studies and the results are published in a peer-reviewed medical journal A policy or contract that provides coverage for prescription drugs may not exclude coverage of a drug for an off-label use of the drug if the drug is recognized for treatment in any of the standard reference compendia or in the medical literature.
If provide coverage for prescription drugs, shall provide coverage for off-label use of a federal FDA approved drug when the drug is prescribed for a life threatening condition or a chronic and seriously debilitating condition, if the use is recognized in one of the listed sources.
If provide coverage for prescription drugs, shall not exclude drug for other indication than approved by FDA if recommended in medical literature.
If provide coverage for prescription drugs, shall provide benefits for expenses incurred in prescribing drugs for treatment for which they have not been approved by the FDA, if the drug is recognized as being medically appropriate for the specific treatment in a listed reference compendia. Off-label drug use is legal when prescribed in a medically appropriate way.
North Dakota Contracts that cover prescription drugs shall provide benefits for expenses incurred in prescribing drugs for treatment for which they have not been approved by the FDA if the drug is recognized as being medically appropriate for the specific treatment in listed reference compendia.
No policy that provides coverage for prescription drugs shall limit or exclude coverage for any drug approved by the FDA on the basis that the drug has not been approved by the United States food and drug administration for the treatment of the particular indication for which the drug has been prescribed, provided the drug has been recognized as safe and effective for treatment of that indication in one or more of the standard medical reference compendia listed.
No policy or contract providing coverage for a prescription drugs shall exclude coverage of that drug for a particular indication solely on the grounds that the indication has not been approved by the FDA if the Health Resources Commission determines that the drug is recognized as effective for the treatment of that indication.
South Dakota If cover prescription drugs shall cover drugs used to treat cancer or other life threatening illness even if they have not been approved by the FDA for that indication if the drug is recognized in medical literature or one of the standard reference compendia. Chapter 3. Clinical Trials Chapter 3. Clinical Trials Table 3.3 States with Statutes for Off-label Prescriptions Not Tied to Specific Diseases or
If cover prescription drugs, shall cover off-label drug use when it is prescribed in a medically appropriate way, and medical literature or standard reference compendia recognize the use. If cover prescription drugs, shall cover off-label drugs used to treat a patient for a covered chronic, disabling or life-threatening illness if recognized for treatment of the illness in a reference compendium or peer-received literature.
If cover prescription drugs, may not exclude coverage on the grounds that the drug is being used for other purposes than approved by the FDA if the drug treatment is recognized in at least one standard reference compendium.
May not exclude coverage on the grounds that the drug is being used for other purposes than approved by the FDA if the drug treatment is recognized in at least one standard reference compendium.
The Council for Affordable Health Insurance lists 36 states with insurance mandates for "Off Label Drug Use" but does not provide information about specific diseases/conditions required to be covered.150 9. The relevant findings of state agencies or other appropriate public organizations relating to the
social impact of the proposed health benefit.
CPHHP staff found no studies from state agencies and public organizations related to the social impact of the services included in the proposed health benefit. Several states have reviewed existing mandates or proposed health benefits related to clinical trials or off-label drug prescriptions related to cancer or in general; however, no reports reviewed the benefits in relation to MS or Parkinson's disease. Records searched included those of states that have or had an established process for studying mandated health insurance benefits, with a relatively large number of mandated health benefits, or located in the Northeast. States searched included Arkansas, California, Colorado, Indiana, Louisiana, Maine, Maryland, Massachusetts, Minnesota, New Jersey, New York, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia, Washington, and Wisconsin.
10. The alternatives to meeting the identified need, including but not limited to, other treatments,
methods or procedures.
Routine patient care costs for clinical trials—The proposed benefit covers routine health care costs which
include a wide range of treatments, procedures, drugs, tests and imaging. In light of a comprehensive
and undefined set of services included in the mandated benefit, identification and review of all potential
alternatives is not attempted.
Off-label prescriptions—Off-label prescriptions are themselves considered an alternative treatment, thus
the alternatives may be standard of care treatments (primarily drugs that are FDA-approved for treatment of
MS and Parkinson's disease) that are ineffective for or not tolerated by a particular patient. Cancer drugs are
prescribed off label because effective treatment options for cancer are often limited, prognoses are often grim,
150 Craig Bunce V, Wieske JP. 2010.
Chapter 3. Clinical Trials Chapter 3. Clinical Trials and submission of FDA applications for every combination of agent and cancer is impractical.151 The same is generally true for off-label prescriptions for MS and Parkinson's disease.
11. Whether the benefit is a medical or broader social need and whether it is consistent with the role
of health insurance and the concept of managed care.
Coverage for routine patient care costs associated with Parkinson's disease and multiple sclerosis clinical trials fulfills a medical need that might not otherwise be met. Currently approved treatment options and disease management strategies for Parkinson's disease and multiple sclerosis are not always successful or may produce intolerable side effects. Parkinson's disease and multiple sclerosis clinical trials attempt to identify treatments and disease management methods that are more effective than those currently available while giving persons with advanced Parkinson's disease and multiple sclerosis treatment opportunities that they would otherwise not be able to access. Required insurance coverage for routine patient care costs associated with Parkinson's disease and multiple sclerosis clinical trials may also serve broad social needs because it may allow the sponsors of clinical trials to reach a larger population of subjects. As such, progress towards more effective Parkinson's disease and multiple sclerosis treatments with fewer side effects are facilitated, contributing to the public good. The use of off-label prescription drugs is a medical treatment and meets medical needs.
As medical needs, coverage of routine patient care costs associated with Parkinson's disease and MS clinical trials and the off-label use of prescriptions are consistent with the role of health insurance and the concept of managed care. One of the roles of health insurance is to provide coverage in the case of serious illness or disease. Parkinson's disease and MS are serious, debilitating diseases. The proposed health benefit is further consistent with the concept of managed care in that the bill includes clauses that allow managed care practices to be implemented in provision of coverage, including subjecting routine patient care costs to the terms conditions, restrictions, exclusions and limitations of the contract or certificate of insurance, including, for example, medical necessity of health care services and limitations on out-of-network care. Prior authorization is a frequently employed managed care tool for costly services, such as some prescription drugs. The proposed benefit does not disallow the use of prior authorization in off-label prescriptions for Parkinson's disease and MS. 12. The potential social implications of the coverage with respect to the direct or specific creation of a
comparable mandated benefit for similar diseases, illnesses, or conditions.
Clinical trials are one of the primary methods of medical research that involve human subjects. Thus, it is possible that the basic structure of the proposed health benefit (i.e., required coverage for routine health care costs for clinical trials enrollees) could be replicated for non-Parkinson's disease and non-MS clinical trials (e.g., clinical trials related to mental health, diabetes, or heart disease.) If denials of insurance coverage for routine patient care costs for patients participating in non-Parkinson's disease and non-MS clinical trials commonly occur or restrict access to care for a particular constituency, it is possible that mandated coverage could be proposed where currently it does not exist.
By the same token, this proposed health benefit may have implications for off-label drugs prescribed for other medical conditions. 13. The impact of the benefit on the availability of other benefits currently offered.
Insurers and MCOs may cut costs by eliminating or restricting access to, or placing limits on other non-
151 Abernethy AP, Raman G, Balk EM, et al. 2009. Systematic review: reliability of compendia methods for off-label oncology indications. Annals of Internal Medicine 150(5): 336-43.
Chapter 3. Clinical Trials Chapter 3. Clinical Trials mandated benefits currently offered. However, the availability of any benefit to be restricted may be limited. Existing benefits may be administratively costly to restrict and insurers may be contractually obligated to provide them. Additionally, many of the benefits that could be targets for elimination are included in plans for competitive advantage.
In general, FDA-approved drugs for treatment of MS are substantially more expensive in comparison to FDA-approved drugs for treatment of Parkinson's disease. Although no evidence of widespread use of off-label use of MS-approved drugs for treatment of Parkinson's disease was found, should the practice become more widely utilized, some effect on the availability of other benefits currently offered is conceivable. In contrast, FDA-approved drugs for treatment of Parkinson's disease are generally less expensive, thus the impact of the availability and utilization of such drugs by persons with MS would be expected to have less effect on benefits currently offered, particularly if the PD drugs were used as substitutes for the more expensive MS drugs.
14. The impact of the benefit as it relates to employers shifting to self-insured plans and the extent to
which the benefit is currently being offered by employers with self-insured plans.
Due to the low number of persons in the fully-insured population with Parkinson's disease and MS and the even lower number of persons participating in Parkinson's disease and MS clinical trials, it is not anticipated that employers would shift to self-funded plans as a result of this health benefit in isolation. Current use of FDA-approved MS drugs for treatment of Parkinson's disease and vice versa is expected to be very low, and the proposed coverage would only apply for plans that provide coverage for prescribed drugs.
There are several reasons for health insurance premium increases, including medical cost inflation, an aging population and an aging workforce, and required benefits or "mandates." Employers contemplating a shift to self-funded plans are likely to weigh these and other factors. Employers also may shift to plans with higher coinsurance amounts to keep premiums at a more affordable level ("benefit buy down"). Benefit buy down can result in employees not taking up coverage and thus being uninsured or not accessing care when it is needed because of high deductibles.
Current coverage of the proposed health benefit in self-funded plans in Connecticut is unknown. A Maryland analysis of existing mandated benefits conducted in 2008 found that "significantly more than half but not all employers with self-funded plans provide benefits" that covered patient costs for clinical trials and "half" of employers with self-funded plans provide benefits for off-label prescriptions.152 If coverage for the mandated benefit in self-funded plans in Connecticut is similar to that in Maryland, it is likely that the proposed health benefit, if enacted, would have little direct effect on employers shifting to self-funded plans.
15. The impact of making the benefit applicable to the state employee health insurance or health
As a self-funded entity, the state employee health insurance or health benefits plan is exempt from state health insurance mandates under the federal Employee Retirement Income Security Act (ERISA). If the state voluntarily provided the services included in the proposed health benefit under review, the social impact of the benefit for the approximately 134,344 covered lives in state employee plans and 30,000 state retirees not enrolled in Medicare153 is expected to be the same or similar to the social impact for persons covered in non-state employee health insurance plans as discussed throughout Section IV of this report. 152 Maryland Health Care Commission. 2008. Study of Mandated Health Insurance Services: A Comparative Evaluation. Available at: . Accessed December 1, 2010.
153 Personal communication. Scott Anderson, State of Connecticut Comptroller's Office. September 14, 2010.
Chapter 3. Clinical Trials Chapter 3. Clinical Trials The actuarial analysis estimates the costs of the services included in the proposed health benefits would be de minimis in the fully-insured population. In terms of financial impact to the state employee health insurance or health benefits plan, it is expected that the costs would also be de minimis.
16. The extent to which credible scientific evidence published in peer-reviewed medical literature
generally recognized by the relevant medical community determines that the services included in
the proposed health benefit are safe and effective.
Routine patient care costs for clinical trials—The proposed health benefit covers routine health care costs
which include a wide range of treatments, procedures, drugs, tests and imaging. In light of a comprehensive
and necessarily undefined set of services included in the mandated benefit, review of the safety and
effectiveness of the services included is not attempted.
Off-label prescriptions—The safety and effectiveness of prescription drugs must be proven for the diseases/
conditions for which they are FDA approved to treat. Review of the safety and effectiveness of all FDA-
approved drugs for Parkinson's disease and MS and their off-label uses is beyond the scope of this analysis.
There are many benefits as well as many risks associated with prescription drug use; drugs approved for
Parkinson's disease and MS are not exempt from these concerns, particularly when off-label use is employed.
Cancer drugs are prescribed off label because FDA-approved treatment options for a specific type of tumor
or stage of cancer may be limited or have been attempted and proven ineffective and prognoses may be grim.
The same is generally true for off-label prescriptions for MS and Parkinson's disease.
The widespread and accepted practice of off-label prescribing in medicine is well-documented in the literature. The use of drug compendia is an effective mechanism for ensuring that patients have access to the safest and most effective drugs or drugs that produce fewer side effects when evidence becomes available to support specific off-label uses.154 One of the primary safety issues concerning off-label prescriptions is related to the drug label. One of the most reliable and easy-to-find sources of information on drugs is the drug label, but drug labels do not contain information regarding off-label use of the drug. Lack of information on off-label drug use and outcomes may put patients at a higher risk for medication errors, side effects, and unwanted drug reactions or interactions with other drugs.155 A reason to attempt to restrict or control widespread off-label use of approved drugs is that it may remove the financial incentive for pharmaceutical manufacturers to conduct clinical trials that would establish the efficacy and effectiveness of the drug for those off-label uses.156 The proposed health benefit excludes coverage of experimental or investigational drugs that are not FDA-approved; an important consideration related to safety and effectiveness.
154 Abernethy AP, Raman G, Balk EM, et al. 2009. Systematic review: reliability of compendia methods for off-label oncology indications. Annals of Internal Medicine 150(5): 336-43 155 American Cancer Society. 2010. Off-label drug use: what problems are caused by off-label drug use? Available at: Accessed on January 10, 2011.
156 Ratner M, Gura T. 2008. Off-label or off-limits? Nature Biotechnology 26(8);871.
Chapter 3. Clinical Trials Chapter 3. Clinical Trials IV. Financial Impact
1. The extent to which the mandated health benefit may increase or decrease the cost of services
included in the proposed health benefit over the next five years.
Routine patient care costs for clinical trials—For MS and Parkinson's disease clinical trials, University
of Connecticut Health Center (UCHC) medical librarians and CPHHP researchers identified no studies
related to increasing or decreasing costs of routine patient care costs. For cancer, UCHC medical librarians
identified a study of the incremental treatments costs in cancer clinical trials. The study found that over a
2.5-year period, direct care costs were 6.5 percent higher for trial participants than nonparticipants.157 The
study found that incremental costs were higher for patients who died and who were in early phase studies
and concluded that the additional treatment costs for government-sponsored cancer clinical trials appear
minimal.158 It is possible that similar financial impact is experienced in MS and Parkinson's disease clinical
trials.
Off label prescriptions—Because off-label prescribing of FDA-approved MS drugs for treating Parkinson's
disease patients and vice versa is expected to occur very rarely, the proposed health benefit is expected to have
little to no impact on the cost of treatment.
2. The extent to which the mandated health benefit may increase the appropriate or inappropriate
use of services included in the proposed health benefit over the next five years.
Routine patient care costs for clinical trials—For those persons whose insurance plans would not
otherwise cover routine patient care costs associated with Parkinson's disease or multiple sclerosis clinical
trials, the proposed health benefit may increase participation in such trials and appropriate use of the service.
For those who are covered by self-funded plans, who use out-of-pocket funds, or who receive routine patient
care costs associated with Parkinson's disease and Multiple Sclerosis clinical trials from other sources, a
mandated benefit may not increase participation or appropriate use.
Inappropriate use is not expected to occur, due to the specific and restricted nature of the development of and highly restricted enrollment procedures for clinical trials. Additionally, the legislation requiring the coverage references eligibility guidelines for Parkinson's disease and multiple sclerosis clinical trials.
Off label prescriptions—If the off-label use of MS drugs for treatment of Parkinson's disease and vice
versa are considered appropriate treatments, then the proposed health benefit could be expected to increase
appropriate use of such drugs. However, professional opinion lends little support to the appropriateness of
these approaches and a dearth of literature was found on the topic.
3. The extent to which the mandated health benefit may serve as an alternative for more expensive
or less expensive treatment, service or equipment, supplies or drugs, as applicable.
Routine patient care costs for clinical trials—The proposed health benefit covers routine health care costs
which include a wide range of treatments, procedures, drugs, tests and imaging. In light of a comprehensive
and undefined set of services included in the mandated benefit, it is not possible to identify and review all
applicable alternatives and whether such alternatives might be more or less expensive.
Off label prescriptions—Prescription drugs used to treat MS are generally more costly than many other
prescription drugs, thus if levels of MS drug utilization increased through increases in utilization by persons
157 Goldman DP, Berry SH, McCabe MS, et al. 2003. Incremental treatment costs in national cancer institute-sponsored clinical trials. Journal of the American Medical Association 289(22): 2970-7.
Chapter 3. Clinical Trials Chapter 3. Clinical Trials with Parkinson's disease, the mandated benefit would be expected to increase costs of their treatment. Professional opinion suggests that the widespread use of MS drugs for persons with Parkinson's disease would be highly unlikely due to the lack of clinical effectiveness and absence of quality of life benefit of use of MS drugs by persons with Parkinson's disease.159 FDA-approved drugs for Parkinson's disease are generally far less expensive than FDA-approved drugs for MS, therefore little effect on costs of treatment would be anticipated through their off-label use. As is the case for off-label use of MS approved drugs among patients with Parkinson's disease, there appears to be no evidence of any clinical effectiveness or quality of life improvements through off-label use of Parkinson's disease approved drugs among persons with MS.
4. The methods that will be implemented to manage the utilization and costs of the mandated health
It is anticipated that insurers and MCOs would employ the same utilization management methods and cost controls that are implemented for other covered benefits as appropriate for the services included in the proposed health benefit. The legislation does not prohibit insurers and MCOs from employing utilization management, prior authorization, or other utilization tools at their discretion. The legislation also defines eligibility guidelines for Parkinson's disease and Multiple Sclerosis clinical trials and "routine patient care costs." Utilization and cost impact is limited due to the low prevalence of the diseases in the population and the small number of beneficiaries enrolled in Parkinson's disease and Multiple Sclerosis clinical trials.
5. The extent to which insurance coverage for the services included in the proposed health benefit
may be reasonably expected to increase or decrease the insurance premiums and administrative
expenses for policyholders.
The design of many clinical research trials is to provide an additional treatment or drug in addition to the standard recommended treatment for the patient's disease or condition. In effect, the "routine patient care costs" for trial participants is the standard recommended treatment. The cost of such "routine" treatment is not insignificant; Parkinson's disease and particularly multiple sclerosis are high cost diseases to treat and for which to provide continuity of care. Connecticut does not require health insurance coverage for Parkinson's disease and Multiple Sclerosis treatment, however, it is expected that such coverage is included in the vast majority of policies issued in Connecticut, thus it is not anticipated that required coverage of routine patient care costs associated with Parkinson's disease and Multiple Sclerosis clinical trials would have a significant effect on health insurance premiums and administrative expenses for policyholders. The off-label prescribing portion of the proposed health benefit is limited to coverage for FDA-approved drugs for a limited set of diseases prescribed by a licensed health care provider for the treatment of MS and Parkinson's disease. It is also limited as to the circumstances under which it may be prescribed: it must be recognized as appropriate for treatment of MS or Parkinson's disease in one of three named reference compendia (two of which no longer exist). Actuarial analysis found a very low prevalence of Parkinson's disease and MS in the Connecticut population; a small number of enrollees in Parkinson's disease and multiple sclerosis clinical trials in Connecticut; and low expected frequency of off-label prescribing for Parkinson's disease and MS as limited by the language included in the bill. The actuarial report estimated the costs of services included in the proposed health benefit to be de minimis. For further discussion, please see Appendix III: Ingenix Consulting Actuarial Report, page 18.
6. The extent to which the services included in the proposed health benefit are more or less expensive
than an existing treatment, service or equipment, supplies or drugs, as applicable, that is
159 Personal communication. Mohamed N. Hassan, MD, PhD.
Chapter 3. Clinical Trials Chapter 3. Clinical Trials determined to be equally safe and effective by credible scientific evidence published in peer-
reviewed medical literature generally recognized by the relevant medical community.
Routine patient care costs for clinical trials—The proposed health benefit covers routine health care costs
which include a wide range of treatments, procedures, drugs, tests and imaging. In light of a comprehensive
and undefined set of services included in the mandated benefit, it is not possible to identify and review all
applicable alternatives and whether such alternatives might be more or less expensive.
Off label prescriptions—Medical librarians and CPHHP researchers found no peer-reviewed medical
literature that discusses the safety, effectiveness and cost-effectiveness of the use of FDA-approved MS
drugs for the treatment of Parkinson's disease or the use of FDA-approved Parkinson's disease drugs for the
treatment of MS.
7. The impact of insurance coverage for the services included in the proposed health benefit on the
total cost of health care, including potential benefits or savings to insurers and employers resulting
from prevention or early detection of disease or illness related to such coverage.
The total cost of health care is understood to be the funds flowing into the medical system, which are the medical costs of insurance premiums and cost sharing. Actuarial analysis estimates the costs of the services included in the proposed health benefit to be de minimis. For further information, please see Appendix III: Ingenix Consulting Actuarial Report, page 7-8.
The services included in the proposed health benefit are related to treatment of established disease, thus no disease prevention or early detection economic benefits are anticipated. Some economic benefit may be realized by patients and their employers if the services included in the proposed health benefit allow those with Parkinson's disease or MS to return to work or foster improved on-the-job productivity.
8. The impact of the mandated health care benefit on the cost of health care for small employers, as
defined in § 38a-564 of the general statutes, and for employers other than small employers.
No published literature was found regarding the effect of mandated coverage for off-label prescriptions and routine patient care costs associated with Parkinson's disease and MS clinical trials on the cost of health care for small employers. Because Connecticut insurers/MCOs are expected to provide coverage for treatment of Parkinson's disease and Multiple Sclerosis and "routine patient care costs" for trial participants is the standard recommended treatment, it is unlikely that the proposed health benefit, if enacted, would result in different effects among different types of employers. For further information regarding the differential effect of the proposed health benefits on small group versus large group insurance, please see Appendix III: Ingenix Consulting Actuarial Report, page 22-23.
9. The impact of the mandated health benefit on cost-shifting between private and public payers of
health care coverage and on the overall cost of the health care delivery system in the state.
Cost-shifting between private and public payers of health care coverage generally occurs when formerly privately insured persons, after enrolling in a public program or becoming un- or underinsured, require and are provided health care services. Cost-shifting also occurs when a formerly publicly-funded service becomes the responsibility of private payers, which can result following enactment of a health insurance mandate. Most persons formerly covered under private payers lose such coverage due to a change in employer, change in employment status, or when private payers discontinue offering health care coverage as an employee benefit or require employee contributions to premiums that are not affordable. Because this proposed benefit is expected to have little financial impact on utilization or costs if enacted, it is unlikely it would have 62 Chapter 3. Clinical Trials Chapter 3. Clinical Trials any impact on cost-shifting between private and public payers of health care coverage. The overall cost of the health delivery system in the state is understood to include total insurance premiums (medical costs and retention) and cost sharing. For reasons described throughout this review and in the actuarial report, the estimated cost of the proposed health benefit, if enacted, is expected to be de minimis.
For further information, please see Appendix III, Ingenix Consulting Actuarial Report.
Chapter 3. Clinical Trials Chapter 3. Clinical Trials Chapter 4
"An expansion of coverage for gastric bypass surgery."
Erin Havens, MPA, MPH University of Connecticut Center for Public Health and Health Policy Chapter 4. Table of Contents
II. Background .68 Table 4.1. International Classification for adult weight status using BMI .69 Table 4.2. Effects of bariatric surgery on obesity-related comorbidities (%) .73 IV. Social Impact.77 V. Financial Impact.88 Table 4.3. Summary of Relative risks and benefits of laparoscopic bariatric surgical Chapter 4. Gastric Bypass Chapter 4. Gastric Bypass I. Overview
On July 22, 2010, the Chairs of the Insurance and Real Estate Committee of the Connecticut General Assembly (the Committee) directed the Connecticut Insurance Department to review "an expansion of coverage for gastric bypass surgery." This review follows the requirements stipulated under Public Act 09-179. Reviews of required health insurance benefits are a collaborative effort of Connecticut Insurance Department and the University of Connecticut Center for Public Health and Health Policy (CPHHP). CPHHP did not receive additional language from the Committee with regard to the intended coverage parameters for gastric bypass surgery. Based on a review of previous bills considered by the Committee, the interpretation used for this review is that "coverage for gastric bypass surgery" refers to gastric bypass for the surgical treatment of clinically severe obesity not the use of gastric bypass as an experimental treatment for reversing Type 2 Diabetes (T2DB) in overweight and slightly obese individuals.
To evaluate the proposed mandate, in January 2011, CPHHP distributed and received responses to a survey requesting related policy documents and data for the proportion of members with policy exclusions, coverage, claims, and utilization review related to bariatric surgery and gastric bypass. Four out of seven Connecticut-domiciled insurers and managed care organizations (MCOs) responded. CPHHP also contracted with Ingenix Consulting (IC) for actuarial and economic analysis of the proposed health benefits. IC analysis estimates the costs for both fully insured group plans and individual health insurance policies. The estimates are based on the potential cost increase in bariatric surgery claims, rather than gastric bypass alone. The cost estimates are also dependent on the assumption that the level of coverage and eligibility parameters required by the mandate are consistent with the average level of coverage available under existing private health plans that do provide coverage. For example, if a proposed mandate sets a coinsurance or maximum benefit level that exceeds the current standard of care among plans with coverage, the expected cost would be greater than that presented in this report. Similarly, if the state requirements for determining eligibility extend eligibility to a larger population than covered among plans with coverage, the expected cost would also be greater than that presented in this report. Overall, the IC projected increase in cost to Connecticut's health care system for a bariatric surgery mandate implemented in 2011 is $10,320,213. This amount includes a $8,019,571 increase in total medical claims, $1,819,468 in retention (administrative expenses plus profit/reserves) and $481,174 in cost sharing. On average, out-of-pocket cost sharing is expected to comprise 4.7 percent of the increase.
Current coverage
Available data does not provide a definitive estimate regarding coverage for bariatric surgery in Connecticut.
Coverage for bariatric surgery is included under certain circumstances under Medicaid and Medicare
whereas the coverage for members of fully insured group and individual plans varied from 0 to 100 percent,
according to Connecticut insurers/MCOs (carriers). Some policies exclude coverage for treatment of
obesity, including bariatric surgery. The coverage available to individuals also varies in terms of deductibles,
coinsurance, maximum benefits, and the health conditions required to determine bariatric surgery as
medically necessary.
Premium impact
Insurance premiums are comprised of carrier paid medical claims and retention. Retention includes
administrative expenses and profit/reserves. The estimated increase projected for covering bariatric surgery
in 2011 represents less than 0.2 percent of the average total monthly premium paid.
Chapter 4. Gastric Bypass Chapter 4. Gastric Bypass Group plans: Ingenix Consulting projects an average increase in premiums of $0.61 per member per month
(PMPM) for employers with fully insured group plans of which $0.50 PMPM is for paid medical costs and
$0.11 PMPM for retention.
Individual policies: The projected increase for individual health plans is $0.44 PMPM of which $0.34
PMPM is for paid medical costs and $0.10 PMPM is for retention.
There is some evidence that improvement or resolution of comorbidities in bariatric surgery patients lead to a decrease in related pharmaceutical and medical care. Over time, these cost-savings may reduce the burden of the surgery cost provided that the cumulative savings are not outpaced by the need for routine nutritional therapy, follow up care or treatment of surgery complications. Some studies suggest a return on investment for bariatric surgery within two to nine years, depending on the type of surgery and whether it is performed laparoscopically.
Self-funded plans
The Ingenix Consulting report suggests that on average self-funded plans in the U.S. cover bariatric surgery.
Surveys of self-funded employers in other states generally report some level of coverage for bariatric surgery,
especially among labor pools and the largest of employers. The responses from the survey of Connecticut-
domiciled insurers/MCOs did not indicate the level of coverage available for the self-funded plans they
administer.
This report is intended to be read in conjunction with the General Overview and the Ingenix Consulting Actuarial Report, which is included as Appendix III. Body Mass Index
The standard international classification system for adult weight status uses a weight-for-height index,
referred to as the Body Mass Index (BMI). The BMI calculation is defined as the weight in kilograms
divided by the square of the height in meters of an adult. BMI scores are classified as underweight, normal
range, overweight, or obesity (Table 4.1). Obesity is further classified into Class I, Class II, and Class III.160
Class III obesity, also labeled extreme obesity, refers to individuals who are about 100 or more pounds
overweight. For example, a person with extreme obesity and a height of 5 foot 8 inches (the average height
of the U.S. adult male)161 would weigh over 263 pounds whereas a normal weight person of the same
height would way between 122 and 164 pounds. Although limitations exist when using BMI as a marker
for overweight and obesity, BMI is strongly associated with body fat mass and health outcomes and is used
in conjunction with waist circumference measurements during medical assessments.162 BMI is also the
predominant measure used in national health surveillance surveys.
160 World Health Organization. BMI classification. Av Accessed February 161 Centers for Disease Control and Prevention. Body measurements. 2009. Available at: Accessed February 23, 2011.
162 Obesity Education Initiative. 1998. Clinical guidelines to the identification, evaluation, and treatment of overweight and obesity in adults. Available at: Accessed February 23, 2011. Chapter 4. Gastric Bypass Chapter 4. Gastric Bypass Table 4.1. International Classification for adult weight status using BMI
Classification
Weight (lbs) for 5'8" height* *average height male, age 20 or older163 Obesity-related Health Concerns
A wealth of research explores the relationship between weight status and disease, disability and death.
Positive associations between obesity and increased risk for hypertension, high blood pressure, cholesterol,
type 2 diabetes (T2DB), coronary heart disease,164 stroke, disability, certain cancers, osteoarthritis, gall
bladder disease and excess deaths have been documented.165 The risk of developing a comorbidity increases
as the degree of obesity increases.166 The National Heart, Lung, and Blood Institute describe disease risk for
T2DB, hypertension and cardiovascular diseases (CVD) relative to the normal weight population by weight
status and waist circumference. Relative to normal weight individuals, individuals who are:
– Overweight have increased or high disease risk; – Class I obese have high or very high risk; – Class II obese have very high to extremely high risk; and – Class III obese have extremely high risk.167 For each weight status, the higher disease risk indicated is for individuals with a waist circumference predictive of substantial abdominal fat (>40 inches for men and >35 inches for women). The most serious health problems are associated with extreme obesity.168 Class III obesity is associated with a 5 to 20 year shorter life expectancy. It is also associated with increased risk of more than thirty illnesses and medical conditions.169 Commonly, Class III or extreme obesity is called morbid obesity or clinically severe obesity due to the increased risk of morbidity and mortality compared to that experienced by adults in other weight classifications.170 In some cases, individuals with Class II obesity and chronic disease(s) or medical condition(s) (comorbidities) such as heart disease, sleep apnea or T2DB are 163 Centers for Disease Control and Prevention. Body measurements. 2009. Av Accessed February 23, 2011.
164 Obesity Education Initiative. 1998. Clinical guidelines to the identification, evaluation, and treatment of overweight and obesity in adults. Available at: Accessed February 23, 2011.
165 American Society for Metabolic & Bariatric Surgery. Obesity in America. Available at: . Accessed February 23, 2011. 166 Hensrud DD, Klein S. 2006. Extreme obesity: a new medical crisis in the United States. Mayo Clinic Proc. October 2006; 81(10, 167 Obesity Education Initiative. 1998. Clinical guidelines to the identification, evaluation, and treatment of overweight and obesity in adults. Available at: Accessed February 23, 2011.
168 Sturm R. 2007. Increases in morbid obesity in the USA: 2000-2005. Public Health 121(7): 492-496.
169 Hensrud DD, Klein S. 2006. Extreme obesity: a new medical crisis in the United States. Mayo Clinic Proc. October 2006; 81(10, Chapter 4. Gastric Bypass Chapter 4. Gastric Bypass also considered morbidly obese.
Obesity Trends and Prevalence
An analysis of data from the National Health Assessment and Nutrition Evaluation Survey (NHANES)
conducted by the National Center for Health Statistics (NCHS) concludes, "The entire adult population
is heavier, and the heaviest have become much heavier since 1980." 171 Similarly, Sturm's analysis of the
Behavioral Risk Factor Surveillance Survey (BRFSS) shows overall obesity prevalence increasing by 24
percent between 2000 and 2005, class III obesity prevalence (BMI ≥40) increasing twice as fast (52 percent)
and the prevalence of BMI ≥50 (about 200 pounds overweight) increasing three times as fast.172
According to NHANES data from 2007-2008 more than one-third of the adult population was obese. 19.6 percent of the population qualified as Class I obese, 8.6 percent as Class II obese and 5.7 percent as Class III obese. The rate of Class III obesity was higher among women (4.2 percent) than men (7.2 percent) and especially high for non-Hispanic black women (14.2 percent).173 In Connecticut, the rate of obesity is significantly lower than the national rate.174 Based on BRFSS for 2009, Connecticut's obesity rate for adults was the second lowest in the nation at 21 percent, compared to a national average of 26.9 percent. The BRFSS obesity estimates are lower than NHANES estimates (above) due to BRFSS' reliance on self-report data for weight and height rather than direct measurement during a physical examination which is the method used for NHANES. For 2007-2008 an additional 7.6 percent adults are identified as obese using NHANES data when compared to BRFSS findings. Since BRFSS estimates are generally biased downward due to underestimating and under-reporting of higher weights, it may be reasonable to assume that the rate of obesity in Connecticut is closer to 30 percent than 21 percent reported under BRFSS. Roughly, 8-12 percent of the adult population would be considered morbidly obese (Class III obese or Class II obese with a comorbid condition).
Treatments for Weight Loss
The NHLBI Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in
Adults states three goals for weight loss and weight management:
1) prevent further weight gain, 2) reduce body weight, and 3) maintain lower body weight over the long term.175 The goals and related treatment guidelines are supported by the medical literature which documents the positive effect of weight loss on reducing the presence and/or development of many chronic diseases and their risk factors.176 The recommended strategies for weight loss include dietary therapy, physical activity, behavior therapy, combining therapy (physical activity and dietary therapy), lifestyle therapy (dietary therapy, physical activity and behavior therapy combined), and in some cases pharmacotherapy or surgery. As noted in the clinical guidelines, weight is usually regained unless a weight maintenance program consisting of dietary therapy, physical activity and behavior therapy is continued indefinitely.177 171 Ogden CL, Carroll MD, McDowell M, et al. 2007. Obesity among adults in the United States—No statistically significant change since 2003-2004. Available at: Accessed February 23, 2011. 172 Sturm R. 2007. Increases in morbid obesity in the USA: 2000-2005. Public Health 121(7): 492-496.
173 Flegal KM, Carroll MD, Ogden CL, et al. Prevalence and trends in obesity among US adults, 1998-2008. JAMA.2010; 303(3): 235-241.
174 Trust for America's Health. 2010. New report: Connecticut ranks second least obese state in the nation. Available at: . Accessed February 23, 2011. 175 Obesity Education Initiative. 1998. Clinical guidelines to the identification, evaluation, and treatment of overweight and obesity in adults. Available at: Accessed February 23, 2011.
176 Ibid.
177 Ibid. Chapter 4. Gastric Bypass Chapter 4. Gastric Bypass The Bariatric Practice Guidelines set by the American Society of Bariatric Physicians (ASBP), a professional organization focused on medical treatment and management of overweight and obese patients, suggests similar modes of treatment. The term "bariatric" refers to the field of medicine pertaining to weight loss,178 the study, prevention or treatment of overweight179 or "relating to or specializing in the treatment of obesity."180 The 2004 ASBP guidelines outline dietary modification, exercise prescription, behavior modification and when appropriate, medication as medical (non-surgical) methods for weight loss and body fat reduction.181 A recent statement by the ASBP in response to lowering BMI standards used to qualify patients for weight loss (bariatric) surgery, states: Bariatric surgery has been and should remain a second line therapy after comprehensive medically-managed weight loss. Bariatric surgery does not end one's challenges with weight; rather, it creates new and different nutritional, medical and psychiatric challenges that must be carefully taken into consideration. In conclusion, the ASBP does not support the lowering of BMI standards to qualify for bariatric surgery.182 There are seven types of bariatric surgeries that are generally accepted for use in the United State as of 2008.
183 The most common procedures are gastric bypass, laparoscopic adjustable gastric band (LAGB also known
as Lap-Band ®), bioliopancreatic diversion with duodenal switch (BPD/DS) and sleeve gastrectomy or
gastric sleeve. 184 Procedures are restrictive, malabsorptive or both. Restrictive procedures limit food intake
by reducing the size of the stomach, either through removal, banding or stapling off a section of the stomach
to create a smaller gastric pouch. Procedures induce the malabsorption of calories and nutrients by changing
the pathway of the food as it travels from the stomach through the small intestine.
Gastric bypass is the most common type of bariatric surgery in the United States and is considered the gold-
standard for bariatric surgery.185 Although the proportion of surgeries by type is changing with the advent
of LAGB, according to a 2008 report 80 percent of bariatric surgeries were identified by the ASBS as gastric
bypass.186 Results from the CPHHP poll of Connecticut bariatric surgery centers with COE designations
suggests that gastric bypass is the procedure used in about 56 percent of weight loss surgeries in the state. In
recent years, the advent of laparoscopic surgery has shifted the procedure away from riskier open surgeries,
significantly reducing complications and decreasing procedure costs. 187 Gastric bypass promotes weight loss
by combining restriction and malabsorption.
The Roux-en-Y gastric bypass (RYGB), typically completed as a hospital-based inpatient procedure, is a
178 MedicineNet.com. Definition of bariatric. Av Accessed February 179 TheFreeDictionary.com. Bariatric. Available at: Accessed February 23, 2011. 180 Merriam-Webster. Bariatric. AvAccessed February 23, 2011. 181 American Society of Bariatric Physicians. About ASBP. Available at: ccessed February, 23 182 American Society of Bariatric Physicians. Bariatric physicians question FDA recommendations to lower BMI requirements for lap-band surgery. Av. Accessed February, 23 2011. 183 Mechanick JI, Kushner RF, Sugerman HJ, et al. 2008. AACE, TOS and ASMBS' Medical Guidelines for Clinical Practice for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric patient. Endocor Pract. 2008;12(Suppl 1).
184 Buchwald H. 2005. Consensus conference statement: Bariatric surgery for morbid obesity: health implications for patients, health professionals, and third-party payers. J Am Coll Surg. 200: 593-604.
185 Mechanick JI, Kushner RF, Sugerman HJ, et al. 2008. AACE, TOS and ASMBS' Medical Guidelines for Clinical Practice for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric patient. Endocor Pract. 2008;12(Suppl 1).
186 Ibid.
187Zhao Y, Encinosa W. Bariatric surgery utilization and outcomes in 198 and 2004. Statistical Brief #23. January 2007. Agency for Healthcare Research and Quality. Rockville, MD. http://www.hcup-us-ahrq.gov/reprts/statbriefs/sb23.pdf.
Chapter 4. Gastric Bypass Chapter 4. Gastric Bypass very invasive surgical procedure where the upper part of the stomach is partitioned from the lower stomach by stapling or separation (but not removal) to form a small (10-30 mL) pouch. The jejunum, which is the first two-fifths of the small intestine beyond the duodenum, is divided into upper and lower parts, and a Y-shaped anastomosis [surgical connection] is formed by "attaching the free end of the lower part of the jejunum to a new outlet on the upper stomach pouch and attaching the free end of what was the upper jejunum to a new opening on the small intestine."188 In other words, the newly created small stomach pouch is connected to the bowel by a piece of small intestine, bypassing most of the stomach.
Laparoscopic Adjustable Gastric Banding is the second most common bariatric surgery in the United
States. Recent estimates suggest that LAGB accounts for 37 percent189 or more bariatric surgeries and that
approximately half of these surgeries are completed at outpatient surgery centers, rather than as hospital-
based inpatient procedures. The CPHHP poll of COE designated bariatric surgery centers suggests
that about 41 percent of bariatric surgeries in Connecticut are for LAGB. The procedure involves the
laparoscopic placement of an adjustable silicone ® band around the stomach and tightening the band to
create two chambers. With the band, the top of the stomach where food and liquid enter is smaller thus
filling quicker and triggering satiety earlier than would occur without the band. The band is lined with an
inflatable balloon which can be inflated or deflated through an access port to manage the tightness of the
band and extent of weight loss.190
Gastric Sleeve or Sleeve Gastrectomy is a newer laparoscopic procedure involving the vertical removal of 85
percent of the stomach so that the remaining stomach takes the shape of a sleeve or tube. The new smaller
stomach or "sleeve" is then closed with staples. At times, this procedure has been used as a staged procedure
to promote initial weight loss and reduce related surgical risk prior to completion of a gastric bypass or other
bypass procedure such as the biliopancreatic diversion with or without a duodenal switch.191
Biliopancreatic Diversion with or without Duodenal Switch: According to the poll of COE designated
bariatric surgery centers in Connecticut, it appears that BPD with or without a duodenal switch is not
offered.
According to the national Healthcare Cost and Utilization Project (HCUP) data from 2004, 98.3 percent of bariatric surgeries were received by 18-64 year olds and 82 percent of patients receiving surgery were women. Only 1.5 percent of surgeries were for adolescents and the elderly combined.192 Bariatric Surgery and Health Improvement
Bariatric surgery in general is documented as an effective strategy for remission of numerous comorbid
conditions, decreased mortality, and greater percentages of excess weight loss. (Excess weight refers to the
pounds that a person weighs that exceed normal weight). Numerous studies reviewing the effectiveness
of bariatric surgery document higher rates of improvement to health when compared to population
counterparts who do not receive bariatric surgery. Table 4.2 presents the preoperative incidence and
postoperation remission rate for conditions such as T2DB and hypertension as summarized in the AACE/
188 Merriam-Webster. Roux-en-Y gastric bypass. Available at: Accessed February 23, 2011. 189 American Society for Metabolic & Bariatric Surgery. 2005. Brief history and summary of bariatric surgery, gastric bypass. Available at: ccessed February 23, 2011. 190 American Society for Metabolic & Bariatric Surgery. 2005. Brief history and summary of bariatric surgery, gastric banding. Available at: Accessed February 23, 2011. 191 Mann D. Gastric sleeve surgery. Consumer Guide to Bariatric Surgery. Available at: Accessed February 23, 2011. 192 Mechanick JI, Kushner RF, Sugerman HJ, et al. 2008. AACE, TOS and ASMBS' Medical Guidelines for Clinical Practice for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric patient. Endocor Pract. 2008;12(Suppl 1).
Chapter 4. Gastric Bypass Chapter 4. Gastric Bypass TOS/ASMBS Guidelines (2008).193 Notably, of the 34 percent of patients who went into surgery with T2DM, 85 percent experienced a remission. Similarly, 66 percent of bariatric surgery patients with hypertension experienced a remission. The same review also notes evidence of reduced mortality with several studies directly attributing the reduction in mortality to myocardial infarction, diabetes and cancer-related deaths. 194 In addition, mechanical improvements may be observed following weight loss. These improvements can include less weight bearing on joints, enhanced lung compliance, and decreased fatty tissue around the neck, which relieves obstruction to breathing.195 Table 4.2. Effects of bariatric surgery on obesity-related comorbidities (%)
Comorbidity
Preoperative incidence Remission >2 years postoperative T2DM, IFG, or IGT Hypertriglyceridemia and low HDL cholesterol Source: This data was presented in the AACE/TOS/ASMBS Bariatric Surgery Guidelines, Endocr Pract. 2008; 14 (Suppl 1). The incidence and remission rates were identified through a review of the literature.
HDL=high-density lipoprotein; IFG=impaired fasting glucose; IGT=impaired glucose tolerance However, it is worth noting that research examining weight loss over time has documented that the durability of weight loss over time is not constant. One review article notes that 20 percent of the surgery population in the study regained the weight. Notably, there is variation in the durability of weight loss over time by type of weight loss procedure.
Bariatric Surgery: Complications
According to Livingston's analysis of multiple national data sets, the complication rate for bariatric
surgery was 7.6 percent in 2006 which is similar to the 4.3 percent rate estimated from The Longitudinal
Assessment of Bariatric Surgery.196 Complications related to bariatric surgery may occur during surgery
or after surgery. Complications that may arise during surgery include pulmonary thromboembolism,197
anastomotic leak (leak at the surgical unions between parts such as the stomach and intestine), wound
infections, bleeding, incidental surgical removal of the spleen, incisional and internal hernias, and clogging
or blocking of the small bowel.198 Postoperative complications include nausea and vomiting, dumping
syndrome and nutrient deficiencies.199 Dumping syndrome is a "condition characterized by weakness,
dizziness, flushing and warmth, nausea, and palpitation immediately or shortly after eating and produced
by abnormally rapid emptying of the stomach especially in individuals who have had part of the stomach
removed." After malabsorptive procedures, nutrient deficiencies are common and adequacy of intake
generally involves ongoing use of supplements and monitoring to confirm appropriate nutrient intake.
193 Ibid. 194 Ibid. 195 Ibid.
196 Livingston EH. The incidence of bariatric surgery has plateau in the U.S. The American Journal of Surgery (2010) 200, 378-385.
197 Pulmonary Thromboembolism as defined by Medterms.com "obstruction of the pulmonary artery or a branch of it leading to the lungs by a blood clot, usually from the leg, or foreign material causing sudden closure of the vessel. About 10-15% of pulmonary embolism patients die" 198 AHRQ-National Guideline Clearing House. 2009. Guideline Summary NGC-7470. World Gastroenterology Organisation Global Guideline: obesity. Avccessed February 23, 2011. Chapter 4. Gastric Bypass Chapter 4. Gastric Bypass Surgery patients may also experience dehydration, bowel obstruction, strictures, adhesions, erosions and ulcers, internal and incisional hernias and gallstones (cholelithiasis). 200 In addition, complications specific to LAGB (a restrictive procedure) include band slippage or erosion and the need for reversal or revision.201 The increased rate of mortality related to bariatric surgery is described in terms of deaths that occur in-hospital (periooperatively), 30 days after the surgery and 90 days after the surgery. The most common causes of death are pulmonary embolism and anastomotic leaks. Increases in bariatric surgery experience and the advent of laparoscopic bariatric surgery methods have generated a substantial decrease in the mortality risks associated with the procedure. In an analysis conducted by the Surgical Review Corporation, mortality rates for 55,567 patients were 0.14 percent for in-hospital mortality, 0.29 percent for 30 day mortality and 0.35 percent for 90 day mortality. Other studies suggest similar mortality rates, ranging from 0.1 to 0.2 percent for nationwide mortality and 0.19 percent for in-hospital mortality for all bariatric discharges in 2004.202 However, a study exploring the risk related to gastric bypass surgery using mortality risk scores based on BMI, male sex, hypertension, risk of pulmonary embolus and patient age suggests that "bariatric surgery is not uniformly a low-risk procedure." The authors found that mortality increased significantly by mortality risk score with mortality rates at 0.31 percent if low-risk, 1.9 percent if intermediate risk and 7.56 percent if high-risk.203 Given elevated risk within subgroups of the population with clinically severe obesity, the authors concluded, "judicious patient selection and diligent periooperative care are imperative."204 Bariatric Surgery Guidelines
The primary guidelines used to determine eligibility for bariatric surgery include the National Institutes of
Health (NIH) Consensus Development Conference Statement in 1991, and two sets of clinical guidelines,
one issued by the NHLBI in 1998205 and the other published jointly by the American Association of
Clinical Endocrinologists (AACE), The Obesity Society (TOS), and the American Society for Metabolic and
Bariatric Surgery (ASMBS) in 2008.
The Medical Guidelines for Clinical Practice for the Perioperative Nutritional, Metabolic, and Nonsurgical Support of the Bariatric Patient, published collaboratively by AACE, TOS, and ASMBS, are based on a critical review of the scientific literature. The guidelines present selection criteria for bariatric surgery in terms of four factors: adult weight, weight loss history, commitment and exclusions.206 The following excerpt from the Medical Guidelines summarizes the criteria for each factor.
– BMI≥40 kg/m2 with no comorbidities – BMI ≥35 kg/m2 with obesity-associated comorbidities 200 Ibid. 201 American Society for Metabolic & Bariatric Surgery. 2005. Brief history and summary of bariatric surgery, gastric banding. Available at: Accessed February 23, 2011.
202 Mechanick JI, Kushner RF, Sugerman HJ, et al. 2008. AACE, TOS and ASMBS' Medical Guidelines for Clinical Practice for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric patient. Endocor Pract. 2008;12(Suppl 1).
203 Nguyen NT, DeMaria EJ, Ikramuddin S, et al. The SAGES Manual: A Practical Guide to Bariatric Surgery. Chapter 31: The Betsy Lehman Center Guidelines for Weight Loss Surgery by Mathew M. Hutter. Springer Science and Business Media, New York. Pp.253-256.
204 Ibid.
205 Obesity Education Initiative. 1998. Clinical guidelines to the identification, evaluation, and treatment of overweight and obesity in adults. Available at: Accessed February 23, 2011.
206 Mechanick JI, Kushner RF, Sugerman HJ, et al. 2008. AACE, TOS and ASMBS' Medical Guidelines for Clinical Practice for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric patient. Endocor Pract. 2008;12(Suppl 1).
Chapter 4. Gastric Bypass Chapter 4. Gastric Bypass Weight loss history:
– failure of previous nonsurgical attempts at weight reduction, including nonprofessional programs (for example, Weight Watchers, Inc) – expectation that patient will adhere to postoperative care – follow-up visits with physician(s) and team members – recommended medical management, including the use of dietary supplements – instructions regarding any recommended procedures or tests – Reversible endocrine or other disorders that can cause obesity – current drug or alcohol abuse – uncontrolled, severe psychiatric illness – lack of comprehension of risks, benefits, expected outcomes, alternatives, and lifestyle changes required with bariatric surgery207 Overall, the Medical Guidelines for patient selection are very similar to those presented in the Consensus Conference Statement and the NHLBI Clinical Guidelines. It is important to note that the Medical Guidelines specify the criteria for patient selection based on adult weight, thus there is no criteria for selecting children or adolescents for participation in bariatric surgery. The lack of a recommendation for children to have this surgery is consistent with the NIH Consensus Conference Statement which concluded that "Children and adolescents have not been sufficiently studied to allow a recommendation for surgery for them even in the face of obesity associated with BMI over 40."208 Despite this consensus, there is a growing trend of adolescents receiving bariatric surgery.
A recent ruling by the Food and Drug Administration (FDA) also diverges from the clinical guidelines for bariatric surgery, expanding coverage below the recommended adult weight thresholds for Allergan's Lap-Band® System, the first LAGB device approved for use in the U.S. As reported by Allergan, the FDA approved use of the Lap-Band® system for "adults with obesity who have failed more conservative weight reduction alternatives, such as diet and exercise and pharmacotherapy, and have a Body Mass Index (BMI) of 30-40 and at least one obesity related comorbid condition.209 Bariatric Surgery: Privileging and Practice Guidelines
The authority to grant clinical privileges for bariatric surgery at a hospital or in a given health system is
within the purview of the individual hospital or health system governing board. However, both the Society
of American Gastrointestinal and Endoscopic Surgeons (SAGES) 210 and the Betsy Lehman Center for
Patient Safety and Medical Error Reduction have issued guidelines to address safety concerns that arose in
the early 2000s.211 As a result, voluntary guidelines and recommendations exist for the credentialing of
surgeons and accreditation of hospitals.
207 Ibid.
208 NIH Consensus Statement Online 1991 Mar 25-27 [cited February 9, 2011],9(1);1-20. 209 Allergan. FDA approves expanded use of lap-band adjustable gastric banding system for obese adults. Available at: Accessed February 23, 2011. 210 Nguyen NT, DeMaria EJ, Ikramuddin S, et al. The SAGES Manual: A Practical Guide to Bariatric Surgery. Chapter 31: The Betsy Lehman Center Guidelines for Weight Loss Surgery by Mathew M. Hutter. Springer Science and Business Media, New York. Pp.253-256.
Chapter 4. Gastric Bypass Chapter 4. Gastric Bypass Hospitals and bariatric weight loss centers can pursue voluntary accreditation program from the American College of Surgeons (ACS) or a Center of Excellence (COE) designation from the ASMBS.212 Administered through the Surgical Review Corporation, a bariatric surgery facility may apply to become a ASMBS Center of Excellence (COE). Connecticut bariatric programs with an ASMBS COE designation as of February 2011 include St. Vincent's Medical Center, Hartford Hospital, Saint Francis Hospital and Medical Center, Middlesex Hospital, The Hospital of Central Connecticut, Hospital of Saint Raphael, and Norwalk Hospital. To become a COE certain criteria related to quality of care must be met. The ACS accreditation requires programs to have the necessary physical resources, human resources, clinical standards, surgeon credentialing standards, data-reporting standards, and quality improvement practice. Danbury Hospital, Greenwich Hospital, Hartford Hospital, and Yale New Haven Hospital have ACS accreditation. As of 2006, CMS requires that for coverage of bariatric surgery, the surgery must be carried out in a facility with an ASMBS COE designation or an ACS accreditation. However, bariatric programs are not required to be ACS accredited or COE designated to operate in the state.
Bariatric Surgery and Health Insurance
During the course of the review, a number of parameters common to policies covering gastric bypass were
identified. Policies reviewed specified coverage in terms of the "surgical treatment of obesity" or bariatric
surgery, rather than a specific procedure such as gastric bypass.
Eligibility: Existing state mandates and some government employee health plans throughout the
country extend coverage for bariatric surgery based on a diagnosis of morbid obesity or clinically severe obesity. Recognized guidelines for bariatric surgery are often referenced or Body Mass Index (BMI) thresholds are set and at times, the presences of co-occurring chronic conditions are required. Some policies are more restrictive than recognized guidelines. Some policies set age thresholds for the covered population, explicitly excluding the child population or requiring additional steps to approve adolescents as eligible.
Benefit design: Mandated and voluntary coverage of bariatric surgery often involves a maximum
benefit amount, a maximum episode, co-insurance, deductibles and other cost control measures. Approval: There are varying criteria used for qualification which may involve age, BMI thresholds,
presence of comorbid conditions, documentation of weight loss history for a specified duration of time, participation in a weight loss or weight maintenance program, commitment to the procedure, a psychiatric consultation, or the need for bariatric surgery to resolve an existing chronic condition for which bariatric surgery.
Exclusion: Policies often include treatment of obesity as an excludable condition thus allowing for
denial of gastric bypass or other bariatric surgeries for the purpose of weight loss.
III. Methods
Under the direction of CPHHP, medical librarians at the Lyman Maynard Stowe Library at the University of Connecticut Health Center (UCHC) gathered published articles and other information related to medical, social, economic, and financial aspects of the required benefit. Medical librarians conducted literature searches using PubMed, Scopus, National Institutes of Health websites, and Google. The primary search terms used include bariatric surgery, metabolic surgery, Roux-en-Y, gastric bypass, gastroplasty, laparoscopy, 212 Ibid. Chapter 4. Gastric Bypass Chapter 4. Gastric Bypass obesity, morbid obesity and weight loss. Supplemental terms included weight loss, economics, utilization, instrumentation, treatment outcome, and hospital costs/trends. Searches were limited to English studies published in the last ten years. An emphasis was placed on identifying systematic reviews, meta-analyses, practice guidelines, and randomized controlled trials.
CPHHP staff conducted independent literature searches using PubMed, Cochrane Database, and Westlaw. Where available, articles published in peer-reviewed journals are cited to support the analysis. Sources of information may also be cited in the absence of peer-reviewed journal articles. Staff also gathered additional information through telephone and e-mail inquiries to appropriate state, federal, municipal and non-profit entities and from internet sources such as the State of Connecticut website, Centers for Medicare and Medicaid (CMS) website, other states' websites, professional organizations' websites and non-profit and community-based organization websites. In addition, CPHHP also conducted a poll of Connecticut bariatric surgery centers with the Center of Excellence designation to assess the type of procedures available, annual patients/surgeries and the distribution of patients by procedure.
CPHHP received responses from Connecticut-domiciled insurers/MCOs to a survey requesting related policy documents and data for the proportion of members with policy exclusions, coverage, claims, and utilization review related to bariatric surgery and gastric bypass. Four out of seven Connecticut-domiciled insurers and managed care organizations (MCOs) responded. CPHHP also contracted with IC to provide actuarial and economic analysis of the proposed health benefit mandate. A description of the methods used for the actuarial analysis and the full report are available under Appendix III. IC analyzed claims data from 2006-2009 using a proprietary national database of commercial health plan insurance claims to inform the cost estimate. The cost estimates calculated by IC are based on the potential cost increase in bariatric surgery claims, rather than gastric bypass alone. The estimates are also dependent on the assumption that the level of overage and eligibility parameters required by the proposed mandate are consistent with the average level of coverage available under existing private health plans that do provide coverage. For example, if a proposed mandate sets a coinsurance or maximum benefit level that exceeds the current standard of care among plans with coverage, the expected cost would be greater than that presented in this report. Similarly, if the state requirements for determining eligibility extend eligibility to a larger population than covered among plans with coverage, the expected cost would also be greater than that presented in this report. IV. Social Impact
1. The extent to which gastric bypass surgery is utilized by a significant portion of the population.
According to the Agency for Healthcare Quality and Research, in 2002 0.6 percent of the population with
morbid obesity underwent surgery for weight loss.213 National estimates suggest that 3.8 bariatric surgeries
per 1,000 people (112,999 procedures) were completed in the United States in 2006. 214 These estimates
calculated by Edward Livingston (2010) are based on data from the National Hospital Discharge Survey
(NHDS), National Inpatient Survey (NIS), and the National Survey of Ambulatory Surgery (NSAS). The
integration of NSAS data allows the estimates generated to capture both inpatient and outpatient surgeries.
Codes used to identify bariatric surgeries often cover a range of procedures. Excluding procedure codes 213 Agency for Healthcare Research and Quality. 2005. AHRQ study finds weight-loss surgeries quadrupled in five years. Available at: Accessed February 23, 2011. 214 U.S. Census Bureau. Annual estimates of the population for the United States, Regions, and States and for Puerto Rico: April 1, 2000 to July 1, 2006. Available at: Accessed February 23, 2011. Chapter 4. Gastric Bypass Chapter 4. Gastric Bypass specific to lap band and gastric procedures not elsewhere classifiable, there were 2.4 surgeries per 1,000 persons (70,688) that were potentially gastric bypass surgeries.215, 216 (About 37 percent of bariatric surgeries were lap band procedures).217 An alternative estimate for gastric bypass surgeries may be that they are closer to just over half of bariatric surgeries.218 The ASMBS estimates 220,000 (7.1 per 1,000 people) as the number of bariatric surgeries in 2008.219 The CPHHP poll of bariatric surgery centers with a "Center of Excellence" or ACS accreditation suggests a ballpark estimate of 2,500-3,500 bariatric procedures completed during 2010. The CPHHP carrier survey of bariatric surgery utilization for fully insured group members permits a rough estimate of 1.8 to 2.2 per 1,000 group members as making bariatric surgery claims in 2010. 220 2. The extent to which gastric bypass surgery is available to the population, including, but not
limited to, coverage under Medicare, or through public programs administered by charities,
public schools, the Department of Public Health, municipal health departments or health districts
or the Department of Social Services.
No information was found that would indicate the Department of Public Health or municipal health departments provide services for gastric bypass surgery or other bariatric surgeries. Under government health programs Medicare and Medicaid, gastric bypass may be covered under certain circumstances. Medicare
Medicare typically does not cover services for obesity. However, Medicare coverage of gastric bypass
surgery is possible in limited situations. Medicare will cover gastric bypass surgery if it is deemed medically
necessary, or if it is necessary to correct an illness that was either caused or aggravated by a person's obesity.
In a 2006 decision, Centers for Medicare and Medicaid Services (CMS) determined that to be considered
for coverage, Medicare beneficiaries were required to have a BMI of 35 or higher, and to have exhibited
or osteoarthritis. In that decision, CMS covered four types of bariatric surgery procedures: open gastric
bypass and laparoscopic Roux-en-Y gastric bypass, laparoscopic adjustable gastric banding, and open
and laparoscopic biliopancreatic diversion with duodenal switch. No other bariatric surgery procedure is
currently covered.
CMS clarified its policy for coverage of bariatric surgery in 2009. CMS specified that T2DB is one of the comorbidities CMS would consider in determining whether bariatric surgery would be covered for a Medicare beneficiary who is morbidly obese, as long as the surgery is furnished at a CMS-approved facility. CMS-approved facilities must be designated as a Center of Excellence by ASMBS/SRC or accredited by the American College of Surgeons . An individual with a body-mass index (BMI) of at least 35 is considered morbidly obese. CMS announced that bariatric surgery will not be covered by Medicare when it is used to treat T2DB in a beneficiary with a BMI below 35.221 215 Livingston EH. 2010. The incidence of bariatric surgery has plateaued in the U.S. The American Journal of Surgery 200: 378-385.
216 U.S. Census Bureau. Annual estimates of the population for the United States, Regions, and States and for Puerto Rico: April 1, 2000 to July 1, 2006. Available at: ccessed February 23, 2011. 217 Livingston EH. 2010. The incidence of bariatric surgery has plateaued in the U.S. The American Journal of Surgery 200: 378-385.
218 Unpublished results. CPHHP poll of bariatric surgery centers with COE designation. February 2011.
219 Weight-control Information Network. Longitudinal assessment of bariatric surgery. Available at: http://win.niddk.nih.gov/publications/labs.htm#howmany. Accessed February 23, 2011. 220 Based on: 1,128 members with claims out of 511,531 fully insured group members221 Centers for Medicare and Medicaid Services. 2009. Decision memo for surgery for diabetes. Available at: ccessed January 26, 2011.
Chapter 4. Gastric Bypass Chapter 4. Gastric Bypass Medicaid
The Connecticut Department of Social Services MMIS Provider Manual allows:
.surgical services necessary to treat morbid obesity when another medical illness is caused by, or is aggravated by, the obesity. Such illnesses shall include illnesses of the endocrine system or the cardio-pulmonary system, or physical trauma associated with the orthopedic system.222 Services to treat obesity, other than those described, are not covered. Generally, hospital stays and hospital outpatient visits are not covered for the treatment of obesity. The Department of Social Services policy states: The Department will not pay for a hospital stay, medical services or for procedures in the treatment of obesity, including gastric stapling. Although obesity is not itself an illness it may be caused by illnesses such as hypothyroidism, Cushing's disease and hypothalamic lesions. In addition, obesity can aggravate a number of cardiac and respiratory diseases as well as diabetes and hypertension. Services in connection with the treatment of obesity could be covered services when such services are an integral and necessary part of course of treatment for one of these illnesses.223 3. The extent to which insurance coverage is already available for gastric bypass surgery.
The CPHHP reviewed the literature and related public hearing testimony and surveyed Connecticut carriers
regarding the level of coverage or policy exclusions for gastric bypass and bariatric surgery. Four out of six
carriers submitted responses. The quality of the responses varied widely with some carriers not submitting
data or policy documents where requested. The resulting response to this question is limited to a summary
of coverage or exclusions described in the policy documents, what was received for data requests, and the
literature review.
Both the literature and public hearing testimony suggest that prior to 2004 carriers covered bariatric surgery. Results from several published national and state level studies indicated that 100 percent of responding carriers covered bariatric surgery or surgical treatment for weight loss or morbid obesity. For the coverage policies in Pennsylvania, a survey found that all plans had a BMI cutoff and 88 percent required a comorbid condition to be present. The requirement for a comorbid condition to be present for patients with a BMI ≥40 removes part of the population from the eligibility pool who would be covered if the ASMBS or NIH guidelines were followed. Even so, concerns with large increases in surgery demand and the potential adverse effect on costs and premiums lead to the withdrawal of such coverage by CIGNA Healthcare in 2004 and Aetna, Inc in 2005.224 A public hearing testimony submitted in 2006 and endorsed by the Connecticut State Medical Society, describes the level of coverage in Connecticut. Beginning in January 2005, all of our state's insurance providers revoked coverage for these 222 Department of Social Services. 2009. Provider Manual: physician. Av Accessed February 23, 2011. 223 Department of Social Services. 2008. Provider Manual: hospital. Available at: . Accessed February 23, 2011. 224 Finkelstein EA, Brown DS, Avidor Y, et al. 2005. The role of price, sociodemographic factors, and health in the demand for bariatric surgery. The American Journal of Managed Care 11: 630-637.
Chapter 4. Gastric Bypass Chapter 4. Gastric Bypass procedures from their general policies. …Insurers, however, continue to recognize the medical validity of these procedures. Despite revoking these procedures from the general policies, riders have been made available to large employer groups. This unfortunately leaves about 50% of our population without access to coverage.225 Similar to the testimony, 2011 correspondence with the Connecticut Insurance Department suggests the extent of coverage as follows: "most all carriers in Connecticut exclude gastric bypass and for that matter any surgery related to weight loss (i.e. bariatric surgery). From time to time gastric bypass will be included as a rider chosen by an employer, but most carriers do not even offer it as a rider."226 The information submitted to CPHHP by carriers provides insight on certain commonalities and variation across insurance carriers in terms of coverage for fully insured group policies and individual plans. Gastric bypass and adjustable gastric bands were listed as medically appropriate procedures. Positions varied across carrier regarding gastric sleeve and biliopancreatic diversion with or without duodenal switch. The individual plans offered by two carriers either exclude coverage or report no coverage for bariatric surgery. One carrier reported bariatric surgery coverage for 100 percent of its members. In 2010 the carrier approved 95 percent of gastric bypass and 92.7 percent of all requests for bariatric surgery.
There is evidence that surgery requests submitted under claims with explicit exclusions for bariatric surgery or gastric bypass may still be approved by a carrier. One such carrier approved 53.8 percent of bariatric surgery and 62.5 percent of gastric bypass requests.
4. If the coverage is not generally available, the extent to which such lack of coverage results in
persons being unable to obtain necessary health care treatment.
Gastric bypass is considered an acceptable method for weight loss for individuals meeting the selection criteria described in the background. The extent to which gastric bypass surgery is considered a "necessary" health care treatment depends on the stakeholder. In either case, gastric bypass is regarded as an effective surgical method for reducing weight and obesity-related morbidity and mortality rates.
A variety of factors influence whether a person would undergo gastric bypass surgery. Access is limited to persons meeting the specified guidelines for adult weight, weight loss history, and commitment. The potential patient also must not meet exclusion criteria or have medical contraindications. 227 For those who are eligible and wanting to pursue surgery, willingness and ability to pay is a key determinant for receiving surgery. Surgery would be unlikely to be provided in the absence of an individual's willingness to pay for the procedure. In some cases, patients may be able to arrange payment plans through the institution or practice offering the surgery or secure a loan. Payment options where a patient can spread payments for the cost of the procedure over an extended period of time could potentially lessen the potential for financial hardship and increase the likelihood that the person elects to undergo the procedure. 225 Public Health Committee. File No. 338. Bill No. SB579. PH Date 3/13/2006. Report on bills favorably reported by committee. Title of Bill: An act concerning health insurance coverage for medical services and treatment for morbid obesity.
226 Communication with Paul Lombardo, (reporting on response from Pat Levesque the manager of the Managed Care Program) Connecticut Insurance Department. January 24, 2011.
227 Mechanick JI, Kushner RF, Sugerman HJ, et al. 2008. AACE, TOS and ASMBS' Medical Guidelines for Clinical Practice for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric patient. Endocor Pract. 2008;12(Suppl 1).nutritional, metabolic, and nonsurgical support of the bariatric patient. (2008) Chapter 4. Gastric Bypass Chapter 4. Gastric Bypass 5. If the coverage is not generally available, the extent to which such a lack of coverage results in
unreasonable financial hardships on those persons needing treatment.
According to the ASMBS, the average cost of bariatric surgery in 2009 was $14,000-26,000.228 The northeast region in the U.S. is generally regarded as being towards the higher end of the cost range. Assuming a gastric bypass surgery cost of $25,000 paying for gastric bypass surgery would consume half the annual income of a family earning $50,000 and one-fourth the income of a family earning $100,000. Even if a health plan covered 80 percent of the cost of gastric bypass surgery, a covered family with an annual income of $50,000 needs to pay 10 percent of their income. Assuming a patient wishes to obtain gastric bypass surgery, the amount that must be covered by the patient may be perceived as a financial hardship even with health insurance coverage. Some financial burdent by be offset under federal tax filings since the cost of surgery to treat weight related illness is a deductible medical cost. The amount of the surgery expense that exceeds 7.5 percent of the Adjusted Gross Income (AGI) can be deducted. To deduct the weight loss surgery expense, the treatment must be for a specific disease diagnosed by a physician (such as obesity, hypertension, or heart disease).229 One recent survey explored the willingness to pay (using contingent valuation methods) for gastric bypass procedures among a privately insured population likely to qualify for bariatric surgery. Participants were asked to rank how likely they would be to undergo gastric bypass or lap-band surgery in the next 5 years under different out-of-pocket cost arrangements. 25.8 percent of participants reported an 80 percent or higher likelihood that they would undergo gastric bypass in the next five years whereas reported likelihoods fell to 10.9 percent at out-of-pocket costs of $25,000. Based on the survey the estimated bariatric surgery demand curve shows: 1) decreasing out of pocket costs from $25,000 to $10,000 results in a small increase in the number of surgeries demanded; and 2) demand is more responsive to changes in out-of-pocket costs when costs are lower than $10,000.230 Another study found that extension of insurance coverage for bariatric surgery did not increase utilization. As suggested by the authors, the lack of an observed increase in utilization may have been influenced by the $5,000 cost-sharing requirement, the economic downturn, not meeting the criteria for surgery, or other factors not related to insurance.231 6. The level of public demand and the level of demand from providers for gastric bypass surgery.
Please refer to the response under Section IV, Social Impact #7 (IV-7), below.
7. The level of public demand and the level of demand from providers for insurance coverage for
gastric bypass surgery.
Public hearing testimony indicates some public and provider demand for gastric bypass for weight loss and health insurance coverage for the procedure. At a public hearing on March 13, 2006 regarding SB-579: An Act Concerning Health Insurance Coverage for Medical Services and Treatment for Morbid Obesity, anecdotal testimonies were given by over a dozen individuals who received gastric bypass. These individuals generally noted the success of gastric bypass in helping them lose weight, gain independence, and reduce 228 229 Internal Revenue Service. 2010. Publication 502: medical and dental expenses. Available at: Accessed February 23, 2011. 230 Finkelstein EA, Brown DS, Avidor Y, et al. 2005. The role of price, sociodemographic factors, and health in the demand for bariatric surgery. The American Journal of Managed Care 11: 630-637.
231 Kim K, White V, Buffington CK. 2010. Utilization rate of bariatric surgery in an employee-based healthcare system following surgery coverage. Obes Surg. 20: 1575-1578.
Chapter 4. Gastric Bypass Chapter 4. Gastric Bypass comorbidities. Most of the individuals also noted the importance of having a good health insurance policy that covered weight loss surgery. The Commissioner of the Department of Public Health and the Executive Director of the Permanent Commission on the Status of Women reported on the decreases in mortality and morbidity for patients undergoing bariatric surgery and the high medical costs attributable to obesity in Connecticut.232 In addition, a bariatric surgeon, a surgical director, a representative of the Connecticut Advanced Practice Nurse Society, and a testimony endorsed by the Connecticut State Medical Society supported the use of gastric bypass surgery and related insurance coverage. Similar testimonies were submitted for an additional bill SB-552: An act concerning health insurance coverage for medical services and treatment for morbid obesity and prosthetic devices. Nearly all of the testimonies submitted during the 2006 legislative session public hearings on SB 579 and SB 552 mentioned the importance of insurance coverage for gastric bypass surgeries. 233 Although public hearing testimony generally reflects support for insurance coverage for gastric bypass surgery, the level of demand for coverage on the part of the general public and broader provider population may differ. Surveys of individuals identified as potentially qualified for weight loss surgery suggest that even at zero cost, only about one out of four individuals indicated an 80 percent or greater chance that they would undergo the surgery in the next five years.234 Furthermore, in some states where gastric bypass was added or under consideration as a state employee health benefit, public opposition was voiced with regard to expending public dollars for gastric bypass.235 8. The likelihood of achieving the objectives of meeting a consumer need as evidenced by the
experience of other states.
As of May 2010, the National Association of Insurance Commissioners identified Maryland, New Hampshire, Indiana, and Virginia as states with mandates either requiring inclusion of coverage or offers of coverage for the surgical treatment of morbid obesity.236 In addition, CPHHP identified a statute from Georgia where insurers are explicitly granted the authority to offer coverage for morbid obesity."237 Excerpts from each statute are provided below. Maryland: Individual or group contracts issued or delivered in the State by insurers and nonprofit health
service plans, health maintenance organizations and managed care organizations.
.shall provide coverage for the surgical treatment of morbid obesity that is (1) recognized by the National Institutes of Health as effective for the long-term reversal of morbid obesity; and (2) consistent with guidelines approved by the National Institutes of Health…An entity subject to this section shall provide the benefits required under this section to the same extent as for other medically necessary surgical procedures under the enrollee' or insured's contract or policy with the entity.238 232 Connecticut General Assembly. Report on Bills Favorably Reported By Committee Public Health Committee. SB-579. March 13, 2006. An act concerning health insurance coverage for medical services and treatment for morbid obesity.
233 Ibid.
234 Finkelstein EA, Brown DS, Avidor Y, et al. 2005. The role of price, sociodemographic factors, and health in the demand for bariatric surgery. The American Journal of Managed Care 11: 630-637.
235 Employee Retirement System of Texas. 2010. Developing a cost-neutral or cost-positive plan for providing bariatric surgery coverage for eligible employees in the group benefits program. A study and recommendation by the Employees Retirement System of Texas. 236 NAIC Compendium of State Laws on Insurance Topics. National Association of Insurance Commissioners. May 2010.
237 Georgia Code Ann. § 33-24-69.7238 Maryland Code of Insurance § 15-839.
Chapter 4. Gastric Bypass Chapter 4. Gastric Bypass New Hampshire: Individual and group health policies.
.shall provide…coverage for the diseases and ailments caused by obesity and morbid obesity and treatment for such, including bariatric surgery, when the prescribing physician has issued a written order stating that treatment is medically necessary and in accordance with the patient qualifications and treatment standards set forth by the American Society for Metabolic and Bariatric Surgery or the American College of Surgeons. Such treatment standards may include, but not be limited to, pre-operative psychological screening and counseling, behavior modification, weight loss, exercise regimens, nutritional counseling, and post-operative follow-up, overview, and counseling of dietary, exercise, and lifestyle changes. The covered insured shall be at least 18 years of age. The benefits included in this section shall be subject to the terms and conditions of the policy and shall be no less extensive than coverage provided for similar conditions or illnesses. 239 Virginia: Individual or group policies offered by insurers or corporations and health maintenance
organizations.
.shall offer and make available coverage under any such policy, contract or plan for the treatment of morbid obesity through gastric bypass surgery or such other methods as may be recognized by the National Institutes of Health as effective for the long-term reversal of morbid obesity…The reimbursement for the treatment of morbid obesity shall be determined according to the same formula by which charges are developed for other medical and surgical procedures. Such coverage shall have durational limits, dollar limits, deductibles, copayments and coinsurance factors that are no less favorable than for physical illness generally. Standards and criteria, including those related to diet, used by insurers to approve or restrict access to surgery for morbid obesity shall be based upon current clinical guidelines recognized by the National Institutes of Health.240 Indiana:
An insurer that issues an accident and sickness insurance policy shall offer coverage for nonexperimental, surgical treatment by a health care provider of morbid obesity: (1) that has persisted for at least five (5) years; and (2) for which nonsurgical treatment that is supervised by a physician has been unsuccessful for at least six (6) consecutive months.(b) An insurer that issues an accident and sickness insurance policy may not provide coverage for a surgical treatment of morbid obesity for an insured who is less than twenty-one (21) years of age unless two (2) physicians licensed under IC 25-22.5 determine that the surgery is necessary to: (1) save the life of the insured; or (2) restore the insured's ability to maintain a major life activity (as defined in IC 4-23-29-6); and each physician documents in the insured's medical record the reason for the physician's determination.241 Georgia: This Code, known as the ‘Morbid Obesity Anti-Discrimination Act' presents the General
Assembly findings and declares support for insurance coverage for and treatment of morbid obesity. The
statute also states that.
Every health benefit policy that is delivered, issued, executed, or renewed in this state or 239 New Hampshire Revised Statute § 415:6-o and 415:18-t. Coverage for obesity and morbid obesity.
240 Virginia Code Ann. § 38.2-3418.13.
241 Indiana Code § 27-8-14.1 Chapter 14.1. Coverage for Services Related to Morbid Obesity.
Chapter 4. Gastric Bypass Chapter 4. Gastric Bypass approved for issuance or renewal in this state by the Commissioner on or after July 1, 1999, which provides major medical benefits may offer coverage for the treatment of morbid obesity.242 9. The relevant findings of state agencies or other appropriate public organizations relating to the
social impact of the mandated health benefit.
Thirty states require a fiscal note or an additional review process for any new required health insurance benefit prior to enactment.243 Searches and inquiries focused on states that have or had an established process for studying mandated health insurance benefits, with a relatively large number of mandated health benefits, or located in the Northeast. States searched included Arkansas, California, Colorado, Indiana, Louisiana, Maine, Maryland, Massachusetts, Minnesota, New Jersey, New York, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia, Washington, and Wisconsin. CPHHP identified several mandated benefit reviews from Maryland regarding surgical treatment of morbid obesity. The other state with a report related to insurance coverage for surgical treatment of morbid obesity was Texas. The type of coverage evaluated in the Texas report is applicable only to group health benefit plans for State employees, not for fully insured group or individual policies. Findings from the reports identified are summarized in this section. In addition, a fact sheet published by the Connecticut Department of Health which highlights some of the social impacts of obesity in the state is also summarized.
Maryland Health Care Commission
Study of Mandated Health Insurance Services: A Comparative Evaluation (January 2008)
As part of a larger evaluation, the MHCC surveyed the extent to which the self-funded market voluntarily covers surgical treatment of morbid obesity. MHCC found voluntary compliance for half of the self-funded market. The report further suggests that the 75 percent of the cost of surgery for morbid obesity would be covered without the mandate. After adjusting for the level of coverage in the self-funded market, the reported marginal cost was 0.2 percent of premiums.244 Bariatric Surgery-Actuarial Analysis-Small Group Market: For the small group market, MHCC estimates an increase in bariatric surgery utilization of 28.3 percent to 124.5 percent. The MHCC also noted that potentially 6 to 9 percent of Maryland adults were morbidly obese, the broad negative health implications of obesity, the apparent effectiveness of weight loss surgery based on the medical literature, and a large public demand for weight loss surgery. The report also noted that the sample of the largest self-funded employers and self-funded organized labor groups surveyed generally provided coverage.245 Employees Retirement System of Texas (ERS)
The report provides an overview of obesity prevalence, the impact of obesity on health and health care costs,
the risks of bariatric surgery and existing coverage for bariatric surgery under state and federal programs,
242 Georgia Code-Insurance-Title 33, Section 33-24-59.7.
243 National Conference of State Legislatures. 2009. Health insurance coverage mandates: Are they too costly? Presentation at the Louisiana Department of Insurance 2009 Annual Health Care Conference. Available at: . Accessed May 7, 2010.
244 Maryland Health Care Commission. 2008. Study of mandated health insurance services: a comparative evaluation. Available at: . Accessed February 23, 2011. 245 Maryland Health Care Commission. 2008. Bariatric surgery actuarial analysis for the small group market. Available at: Accessed February 23, 2011. Chapter 4. Gastric Bypass Chapter 4. Gastric Bypass mandates or government employee health plans. The crux of the report projects the potential impact of an articulated set of benefits related to bariatric surgery. ERS projects that 1 to 5 percent of the morbidly obese population (which was estimated at 6-8 percent of the workforce) would become surgery patients per year with 97 percent undergoing laparoscopic procedures and the remaining 3 percent undergoing open surgery at an average cost of $13,000 (the maximum benefit stated in the proposed policy) for a total annual cost of $1.4 to $6 million per year (including costs related to 1 month pre-surgery and 2-months post-surgery). Based on available claims data and a methodology used by Cremieux, et al, ERS estimates that the 24 months as the average minimum time before surgery costs are offset by post-surgery savings.246 Connecticut Department of Public Health
Although not a mandated benefit review, the State Department of Public Health has published fact sheets
on obesity in Connecticut. Information on prevalence, comorbidity and the economic impact of obesity
is summarized using data up through 2003-2004. Facts presented show a higher prevalence of comorbid
conditions such as hypertension, arthritis and diabetes were experienced by Connecticut adults who were
obese compared to adults with a healthy weight. The positive correlation between body mass index and
arthritis, diabetes, and hypertension for Connecticut adults is also presented.247
10. The alternatives to meeting the identified need, including but not limited to, other treatments,
methods or procedures.
Bariatric surgery may be considered when typical intervention (i.e. drug therapy, low-calorie diets, dietary counseling, behavioral modification therapy, exercise) does not lead to adequate weight loss or resolution of obesity-related comorbidities. There are seven commonly accepted bariatric surgeries. A detailed description of two procedures (laparoscopic adjustable gastric banding (LAGB) and sleeve gastrectomy are provided in the background. These procedures represent the other bariatric procedures reported by accredited bariatric programs as available. Notably, some health plans may consider sleeve gastrectomy as unproven and thus not covered. 11. Whether the benefit is a medical or broader social need and whether it is consistent with the role
of health insurance and the concept of managed care.
The purpose of bariatric surgery, including gastric bypass, is to promote dramatic weight loss when other strategies have failed as a means to resolve medical issues related to clinically severe obesity. As described in the background, severe obesity substantially increases the risk for physical conditions and comorbid chronic diseases. Gastric bypass has been associated with dramatic weight loss and resolution of a number of severe medical conditions. To the extent that use of gastric bypass follows the guidelines established for bariatric procedures, the proposed mandate addresses the medical need of reducing the risk of complications related to obesity. The intent of gastric bypass is not for use simply to promote weight loss and change appearance.
Insurance is used to provide a financial safety net for times when an unexpected event with high cost occurs. Instead of potentially experiencing the uncertainty of potential financial losses related to incidents such as sickness, injury or accident, people often elect to pay a certain premium for protection if such an event were to occur. Through premiums, the cost of incidents that do occur is spread across all premium payers, rather than an individual bearing the cost. Gastric bypass surgery is a very high cost procedure with the medical potential for reducing morbidity and mortality related to clinically severe obesity. It has been estimated that 246 Employee Retirement System of Texas. 2010. Review, discussion and consideration of the health insurance plans under the Texas Employees Group Benefits Program. Available at: . Accessed February 23, 2011. 247 Connecticut Department of Public Health. The obesity challenge in Connecticut. Available at: ccessed February 23, 2011. Chapter 4. Gastric Bypass Chapter 4. Gastric Bypass the cost of covering gastric bypass surgery could be recouped in as little as two years given certain coverage parameters.
Whether requiring coverage for gastric bypass is consistent with the concept of insurance could be debated. To some extent, this debate is reflected in the changing parameters for bariatric surgery coverage under insurance policies over time as described under Section IV: Social Impact #3. Since the insurer/MCO policy language submitted to CPHHP does not specify how the benefit would be administered, it is assumed that the proposal is consistent with the concept of managed care and the use of benefit design strategies such as co-insurance, deductibles, and preauthorization would be permitted to manage the cost of the benefit.
12. The potential social implications of the coverage with respect to the direct or specific creation of a
comparable mandated benefit for similar diseases, illnesses, or conditions.
It is possible that a comparable mandated benefit could be proposed for other types of bariatric surgeries or for alternative treatments for extreme obesity such as physical exercise programs, diet-related programs, or counseling. Future mandates may extend benefits to overweight or less-obese (Class I and Class II) individuals. It is also possible that mandated benefits may extend the use of gastric bypass for the treatment of conditions other than obesity, such as diabetes. 13. The impact of the benefit on the availability of other benefits currently offered.
The Ingenix Consulting actuarial report anticipates that "an incremental cost increase of 0.5% is not likely
to be highly noticeable during a period when health plans increase in premium cost [is] approximately 8%
to 10% per year." The average change in cost due to the predicted increase in bariatric surgery claims
following a coverage mandate will be less than 0.2 percent of the average monthly premium according to
Ingenix Consulting. This cost is likely to continue to increase for several years due to a period of increased
utilization as a result of pent up demand. However, given the size of the increase, it is not expected that
other benefits will be noticeably impacted as a result of the mandate. Notably, in the longer run, some
research suggests that reduction in comorbid conditions following surgery may result in a level of reduced
medical costs that offsets the cost of the surgery, associated complications and postoperative medical
interventions such as routine nutrition supplements within two to nine years.
In a case where the premium increases are noticeable, individuals and groups may respond by purchasing a lower level of coverage with increased member cost-sharing, which is referred to as a "benefit buy-down." Increased member sharing may result in benefits becoming less accessible for certain populations due to higher copays. There is some concern that high cost-sharing may lead to individuals foregoing necessary medical services or high-benefit preventive services.
For addition description of the effect of mandates on the availability and cost of health insurance refer to Section II.6 of the Ingenix Consulting report located in Appendix III.
14. The impact of the benefit as it relates to employers shifting to self-insured plans and the extent to
which the benefit is currently being offered by employers with self-insured plans.
The Ingenix Consulting actuarial report suggests that on average self-funded plans in the U.S. cover bariatric surgery. Surveys of self-funded employers in other states generally report some level of coverage for bariatric surgery, especially among labor pools and the largest of employers. In one state, about half of self-funded plans covered bariatric surgery. The responses from the survey of Connecticut-domiciled insurers/MCOs did not indicate the level of coverage available for the self-funded plans they administer.
As described in the preceding response (Section IV: Social Impact #13), the cost increase expected from Chapter 4. Gastric Bypass Chapter 4. Gastric Bypass a bariatric surgery mandate is not likely to be highly noticeable within the broader context of medical inflation. Employer decision to shift to self-funded from fully insured are influenced by a variety of factors. A major component of that decision relates to the profit charges and the premium tax which are costs that must be paid for fully-insured groups and individual health policies. Self-funded groups are exempt from these premium taxes, (1.75 percent of premium) and pay less in profit charges. As described by Ingenix Consulting, The largest self-funded groups are able to exert considerable leverage on the level of administrative fee that the insurer charges them to administer their self-funded business. It is likely that these large group economies of scale play a much more important role in the growth and size of the self-funded sector than does opposition to mandates. Self-funded groups are also exempt from the purview of state mandated health benefits. Even so, as described in the CPHHP report on existing mandates, the majority of self-funded employers voluntarily cover the health benefits required of fully-insured group plans. Within the context of benefits offered to keep a competitive edge, switching to self-funded may not translate into the employer offering less of the mandated benefits or substantially decreasing premium costs as a result of being exempt from state health benefit mandates.
15. The impact of making the benefit applicable to the state employee health insurance or health
benefits plan.
As reported in an interview with the State of Connecticut Comptroller's Office, the state employee medical plans cover surgical treatment for the treatment of morbid obesity, which includes gastric bypass. Coverage is subject to documentation of medical necessity and utilization review.248 As one of the available policies states,"The surgical treatment or hospitalization for the treatment of morbid obesity, except when determined to be medically necessary" are "not covered services…except when approved…as part of case management." Policy language also suggests that except when approved as part of case management, care, treatment, procedures, services or supplies that are primarily for dietary control including, but not limited to, any exercise or weight reduction programs, whether formal or informal, and whether or not recommended by a physician or provider." The proposed mandate language submitted for review does not specify parameters for benefit design or participant eligibility related to gastric bypass thus it is assumed that the state employee health plans are already consistent with the proposal. Of note, as a self-funded group, the health plans administered for State of Connecticut employees are exempt from state health benefit mandates under the federal Employee Retirement Income Security Act (ERISA). The switch from fully-insured group health plans to self-funded health plans became effective July 1, 2010.
16. The extent to which credible scientific evidence published in peer-reviewed medical literature
generally recognized by the relevant medical community determines gastric bypass to be safe and
effective.
As described in the medical literature for bariatric surgery, gastric bypass as a specific type of bariatric surgery has been documented as safe and effective. Numerous guidelines and systematic reviews refer to gastric bypass as the gold standard for bariatric surgery. Gastric bypass is commonly noted for the high rates of percent excess weight loss and substantial reductions in comorbid conditions observed following surgery. 248 Personal communication. Scott Anderson and Helen Sullivan, Comptroller's Office. February 15, 2010.
Chapter 4. Gastric Bypass Chapter 4. Gastric Bypass The following are findings summarized in a 2008 systematic review of the literature published in the AACE/TOS/ASMBS Bariatric Surgery Guidelines:249 – Excess weight loss of 48-85 percent at 1-2 years and 25-68 percent after 7-10 years – Prevalence of metabolic syndrome decreases – Insulin sensitivity improved by 5 months post op – Remission of T2DB by 83-92%.
In most cases, when compared to other types of bariatric surgery, the improvements observed for gastric bypass are significantly greater. However, a higher risk of complications is also commonly associated with gastric bypass with mortality rates. Findings from a U.S. Academic Medical Center cohort study which includes 29 medical centers, found a compliation rate of 16 percent, an anastomotic leak rate of 1.6 percent, a 30-day readmission rate of 6.6 percent and a 30-day mortality rate of 0.4 percent.250 Similarly, a 15-year study of surgeries in a French hospital reports a mortality rate of 0.5 percent for bariatric surgery. 251 V. Financial Impact
1. The extent to which the mandated health benefit may increase or decrease the cost of gastric
bypass surgery over the next five years
The Ingenix Consulting actuarial report suggests that in the initial year of the mandate, the total premium increase for the mandate would be less than 0.2 percent of the premium or 0.61 PMPM. For each subsequent year, the expected increase in cost assumes a 15 percent utilization increase and a 5 percent trend increase. By 2015, the premium cost attributable to the mandate is projected at $1.27 for the premium cost (which equals the paid medical cost plus retention).
The unit cost of bariatric surgery and gastric bypass has been decreasing in recent years.252 To a large extent, this decrease is attributed to the shift towards laparoscopic from open surgery for gastric bypass and the shift toward LAGB from gastric bypass. LAGB is often conducted in an outpatient setting and when conducted on an inpatient basis the stay is often less than 24 hours compared to an approximate two day stay for gastric bypass. The shift to laparoscopic surgery from open surgery has lead to a reduction of complications and thus shorter hospitalizations resulting in lower costs. Other research suggests that surgeries conducted in Centers of Excellence or high volume surgery centers compared to low volume surgery centers are associated with lower rates of complications and lower costs.253 Proficiency at the provision of bariatric surgery, as evidenced by the number of surgery completed, has been shown to be a predictor of complications. If Connecticut has an inadequate supply of bariatric surgeons for the increase in demand, surgeons with less experience may begin conducting procedures which may in turn lead to higher complication rates and higher unit costs.
2. The extent to which the mandated health benefit may increase the appropriate or inappropriate
use of the treatment, service or equipment, supplies or drugs, as applicable, over the next five
249 Mechanick JI, Kushner RF, Sugerman HJ, et al. 2008. AACE, TOS and ASMBS' Medical Guidelines for Clinical Practice for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric patient. Endocor Pract. 2008;12(Suppl 1).
250 Nguyen NT, Silver M, Robinson M et al. 2006. Results of a national audit of bariatric surgery performed at academic centers: a 2004 University Health System Consortium Benchmarking Project. Arch Surg. 2006 May; 14(5): 445-9; discussion 449-50.
251 Chevallier JM. 2010. From bariatric to metabolic surgery: 15 years experience in a French university hospital. Bull Acad Natl Med. 194(1): 25-36; discussion 36-8.
252 Zhao Y, Encinosa W. Bariatric surgery utilization and outcomes in 1998 and 2004. Statistical Brief #23. January 2007. Agency for Healthcare Research and Quality. Rockville, MD. http://www.hcup-usahrq.gov/reprts/statbriefs/sb23.pdf.
253 Encinosa WE, Bernard DM, Du D, Steiner CA. Recent improvements in bariatric surgery outcomes. Medical Care. 2009; 47:531-535 Chapter 4. Gastric Bypass Chapter 4. Gastric Bypass The research on changes in utilization following the introduction of insurance coverage for bariatric surgery suggests minimal changes in utilization. One study looks at the extension of coverage by the Florida Hospital Healthcare System (FHHS) to employees of the eight hospitals and insured family members.254 Despite the introduction of insurance coverage, the rate of utilization among employees potentially eligible for surgery did not increase. Prior to the coverage policy, 1.7 percent of the bariatric eligible received surgery compared to 1.4 percent of the bariatric eligible population in the year after coverage was implemented.255 A subsequent report by the Maryland Healthcare Commission (MHCC) documents a declining annual growth rate for inpatient bariatric surgeries in Maryland from 2001 to 2006. 2001 marked the introduction of coverage for bariatric surgery as a mandated benefit in the state and the extension of coverage under Medicare and Medicaid. The annual rate of change (which includes the self-funded groups not subject to the mandate) was greatest from 2001-2002 (92 percent) followed by a steady decrease.256 The percent change for subsequent years was 57.0, 36.1, 16.8, and 1.0 for 2002-2003, 2003-2004, 2004-2005 and 2005-2006 respectively. There are several potential factors involved in the observed decrease in the annual growth rate. The summary provided in the MHCC report, describes it as follows, "First, as a medical intervention becomes more broadly available, the rate of growth slows even as the number of individuals receiving the intervention continues to increase. Second, treatment of the condition has begun to migrate to the outpatient setting."257 This is especially the case with the LAGB procedure, for which the FDA approved the Lap-Band device in 2001.
3. The extent to which gastric bypass surgery may serve as an alternative for more expensive or less
expensive treatment, service or equipment, supplies or drugs, as applicable.
National guidelines recognize bariatric surgery as a potential strategy for a select population (described in the background) when medical (non-surgical) interventions such as diet, dietary counseling, behavioral modification therapy, exercise, and weight loss programs have not led to successful weight loss and maintenance.258 The success of bariatric surgery is generally evaluated in terms of related weight loss and surgery-related complications or necessary follow-up care. Gastric bypass is considered the gold standard for bariatric surgery and is the most common type of bariatric surgery in the United States and internationally.259 In comparison to other restrictive weight loss procedures, gastric bypass results in greater success in terms of immediate and longer-term weight loss.260 Although more successful at generating weight loss, the risk of complications and the types of follow-up care related to surgery tend to be greater than restrictive surgical 254 To be eligible for coverage, employees needed to have two years of consecutive coverage under the FHHS system, a previous medically supervised diet, and a copay of $5,000. The basis for qualification for surgery included meeting all the parameters outlined by the National Institutes of Health and those specified by the Florida Hospital COE program. The age range to qualify for surgery was 18-65 with the standard BMI requirement.
255 Kim K, White V, Buffington CK. Utilization rate of bariatric surgery in an employee-based healthcare system following surgery coverage. Obes Surg (2010) 20: 1575-1578.
256 Maryland Health Care Commission. 2007. Update on the utilization review of the surgical treatment of morbid obesity. December 2007. Maryland Health Care Commission. 2008. Av. Accessed February 23, 2011.
257 Maryland Health Care Commission. 2007. Update on the utilization review of the surgical treatment of morbid obesity. December 2007. Maryland Health Care Commission. 2008. page 8. Av. Accessed February 23, 2011.
258 Bray GA. 2010. Overview of therapy for obesity in adults. UpToDate Online 18.3. Last literature review version 18.3: September 2010. This topic last updated: January 22, 2010. 259 Tice JA, Kartiner L, Walsh J, et al. 2008. Gastric banding or bypass? A systematic review of comparing the two most popular bariatric procedures. The American Journal of Medicine 121(10).
260 Pories WJ. 2008. Bariatric surgery: risks and rewards. The Journal of Clinical Endocrinology & Metabolism 93(11): S89-S86.
Chapter 4. Gastric Bypass Chapter 4. Gastric Bypass alternatives such as the laparoscopic adjustable gastric band (LAGB or lap-band).261 A 2009 evidence based review by Farrell and colleagues compares the relative risk and benefits of gastric bypass, LAGB and BPD. For reference, the results of their analysis are in Table 4.3. Each procedure is ranked as 1, 2, or 3 where 1 indicates the mandate with the relative position for the specified risk or benefit.262,263 Table 4.3. Summary of Relative risks and benefits of laparoscopic bariatric surgical
procedures263
BenefitsMost effective durable weight loss* Least chance of inadequate weight loss* Best comorbidity resolution* Durable weight loss despite poor patient compliance RisksLeast perioperative risk* Best procedure for avoiding reoperation due to: OtherMost reversible Fewest outpatient visits needed Fewest unintended metabolic consequences of poor According to the review, BPD is associated with the highest level of benefit followed by gastric bypass and then LAGB with regard to durable weight loss, the best comorbidity resolution, the least chance of inadequate weight loss, and durable weight loss despite poor compliance with lifestyle changes following surgery. However, BPD also poses the highest perioperative risk and receives the lowest rank (3) in terms of avoiding early technical complications and late metabolic complications. On the other hand, gastric bypass receives the next highest ranking in terms of benefits and at lower risk than BPD. The analysis of outcomes from bariatric surgeries conducted over a 15 year period at a hospital in France illustrates the increased risk associated with more effective bariatric procedures. Chevallier (2010) found that excess weight loss at two years for LAGB, gastric sleeve, gastric bypass and BPD respectively is 49%, 56%, 63.3% and 73.3% and the mortality rates are 0.1%, 0.15%, 0.5% and 0.8%.264 4. The methods that will be implemented to manage the utilization and costs of gastric bypass
261 Ibid.
262 Farrell TM, Haggerty SP, Overby DW, et al. 2009. Clinical application of laparoscopic bariatric surgery: an evidence-based review. Surg Endosc 23: 942.
263 Ibid. 264 Chevallier JM. 2010. From bariatric to metabolic surgery: 15 years experience in a French university hospital. Bull Acad Natl Med. 194(1): 25-36; discussion 36-8.
Chapter 4. Gastric Bypass Chapter 4. Gastric Bypass This review evaluates the impact of "an expansion of coverage for gastric bypass surgery." No additional language for the proposed health benefit was received. Therefore, it is assumed that health plan carriers may continue to use benefit design and patient selection criteria to manage the utilization and costs related to gastric bypass surgery as they would in the absence of a related mandate. The primary difference would be that if gastric bypass had been an excluded procedure or obesity an excluded diagnosis, gastric bypass procedures would no longer be deniable based on these criteria.
Patient selection criteria generally reflect the components defined in the ASMBS and other national guidelines related to bariatric surgery. In some cases, BMI and comorbidity guidelines are more stringent than those specified in guidelines from professional medical organizations. For example, as summarized by Employee Retirement Services of Texas, Blue Cross Blue Shield of Texas Medical Policy Guidelines require medical documentation of a five-year history of morbid obesity, participation in a non-surgical comprehensive weight loss program for twelve consecutive months prior to applying for predetermination of coverage, participation in a medically supervised lifestyle management program for twelve months following surgery and a BMI of ≥40 with at least one comorbidity that is uncontrolled via "maximum medical management, and which is generally expected to be reversed or improved by bariatric treatment."265 Benefit design components may also require predetermination and preauthorization prior to surgery, restriction on where and which providers may provide surgery (e.g. Centers of Excellence, "in-network" providers), a maximum lifetime benefit of one bariatric surgery, a maximum surgery benefit (e.g. $13,000 paid cost), a separate deductible for bariatric surgery ($5,000), and co-insurance (e.g. 20 percent of the costs related to surgery). For example, under the bariatric surgery coverage proposed for the HealthSelect plan in Texas, coverage allows for one bariatric surgery per lifetime for a maximum covered amount of $13,000. The patient must pay a separate $5,000 deductible for the surgery plus 20 percent of the total charges related to the surgery. 266 Additional examples of benefit plan design are described in the response to Social Impact, response #2. As described, Medicare provides coverage for bariatric surgery as it relates to an uncontrolled comorbidity that is expected to resolve with the treatment of obesity. Furthermore, the Medicare plan design also limits coverage to surgeries performed at an authorized Center of Excellence (COE). To become a COE, a certain threshold of bariatric procedures must be completed. The underlying rationale is that institutions and surgeons with higher levels of experience in bariatric surgery have lower rates of complications during or after surgery. A recent study analyzing error rates before and after the COE requirement, reflect an association between the COE requirement and a reduced rate of complication.267 Potentially, the use of COEs may reduce the charges associated with bariatric surgery.
5. The extent to which insurance coverage for gastric bypass surgery may be reasonably expected to
increase or decrease the insurance premiums and administrative expenses for policyholders.
Insurance premiums are comprised of carrier paid medical claims and retention. Retention includes administrative expenses and profit/reserves. Ingenix Consulting projects an average increase in premiums of $0.61 PMPM for employers with fully insured group plans of which $0.50 PMPM is for paid medical costs and $0.11 PMPM for retention. The projected increase for individual health plans is $0.44 PMPM 265 Employee Retirement System of Texas. 2010. Developing a cost-neutral or cost-positive plan for providing bariatric surgery coverage for eligible employees in the group benefits program. A study and recommendation by the Employees Retirement System of Texas. 266 Ibid.
267 Nguyen NT, Paya M, Stevens M, et al. 2004. The relationship between hospital volume and outcome in bariatric surgery at academic medical centers. Ann Surg. 2004 October; 240(4): 586-594.
Chapter 4. Gastric Bypass Chapter 4. Gastric Bypass of which $0.34 PMPM is for paid medical costs and $0.10 PMPM is for retention. The estimated increase projected for covering bariatric surgery represents less than 0.2 percent of the total monthly premium paid. There is some evidence that improvement or resolution of comorbidities in bariatric surgery patients lead to a decrease in related pharmaceutical and medical care. Over time, these cost-savings may reduce the burden of the surgery cost provided that the cumulative savings are not outpaced by the need for routine nutritional therapy, follow up care or treatment of surgery complications. 6. The extent to which gastric bypass surgery is more or less expensive than an existing treatment,
service or equipment, supplies or drugs, as applicable, that is determined to be equally safe and
effective by credible scientific evidence published in peer-reviewed medical literature generally
recognized by the relevant medical community.
On average, gastric bypass is generally reported to be a more expensive procedure than LAGB. Although the procedure costs more, gastric bypass is also considered more effective. Campbell and colleagues (2010) compared the cost-effectiveness of LAGB and gastric bypass with consideration of likelihood of changes in BMI, the probability of improvements and cost-savings related to improving comorbid conditions, treatment-related adverse events, probability of surgery reversal, survival and health-related quality of life. The probabilities used in the model were based on published research. Cost-effectiveness was measured in terms of the incremental cost-effectiveness ratio (ICER) of a given procedure compared to not having the procedure. The ICER is expressed as the long-term cost per quality-adjusted life years (QALY) gained as a result of the bariatric surgery. Campbell and colleagues (2010) found neither approach to be cost-saving but both approaches to be cost-effective with costs of less than $15,000 per QALY. The cost-effectiveness of these bariatric procedures compare favorably with other cost-effectiveness studies for the use of major surgeries for the treating chronic conditions.268 7. The impact of insurance coverage for gastric bypass surgery on the total cost of health care,
including potential benefits or savings to insurers and employers resulting from prevention or
early detection of disease or illness related to such coverage.
The total cost of health care is understood to be the funds flowing into the medical system, which are the medical costs of insurance premiums and cost sharing. According to Ingenix Consulting, the potential increase in health care spending for requiring bariatric surgery coverage in 2011 would be $8,500,745, of which $8,019,571 is for insurer/MCO paid medical costs and $481,174 represents cost-sharing paid out-of-pocket by bariatric surgery patients. Cost sharing represents 5.7 percent of the predicted increase in the total cost of health care for requiring bariatric surgery coverage.
The potential benefit to insurers may be an offset in paid medical claims over the lifetime of a bariatric patient. Published estimates on bariatric surgery related cost savings vary substantially due to differing approaches. Estimates comparing the use of specific medications before and after surgery or care related to a specific comorbid condition commonly show that costs related to the comorbid condition have often been reduced or eliminated to an extent greater than the initial cost of surgery. 269, 270 The range of available projections predicting return on investment for bariatric surgery range from 24 months to nine years 268 Campbell J, McGarry LJ, Shikora SA, et al. Cost-effectiveness of laparoscopic gastric banding and bypass for morbid obesity. Am J Manag Care. 2010; 16(7): e171-e187.
269 Sampalis JS, Liberman M, Auguer S, et al. The impact of weight reduction surgery on health-care costs in morbidly obese patients. Obes Surg. 2004: 14: 939-47. 270 Gallagher SF, Banasiak M, Gonzalvo, et al. The impact of bariatric surgery on the Veterans Administration healthcare system: a cost analysis. Obes Surg. 2003; 13:245-8.
Chapter 4. Gastric Bypass Chapter 4. Gastric Bypass depending on the type of procedure and model assumptions.271, 272, 273 On the other hand, estimates that consider the broader possibility of long term health outcomes, fluctuations in BMI following surgery, and the cost impact of complications and follow-up care such as treatment of nutrient deficiencies have found bariatric surgery to be cost-effective but not cost saving.
The potential for cost-saving is higher for the employer than the insurer. Several researchers have documented improvements in worker productivity following bariatric surgery.274, 275 One study found that obese workers had 87.8 percent the productivity of workers in general prior to surgery. Prior to surgery the median and mean work days lost for the prior year due to illness or injury was 33 days compared to a 3 days in the general population. Following surgery, workers missed 0-1 days.276 The research suggesting cost-savings from improvements to worker productivity often face methodological limitations such as lack of a control group or reliance on self-reported data.
8. The impact of the mandated health care benefit on the cost of health care for small employers, as
defined in section 38a-564 of the general statutes, and for employers other than small employers.
The average change in employer cost will be less than 0.2 percent the cost of the monthly premium. As described under Section IV: Social Impact #13, the impact of this increase in cost within the general trend of premiums rising by 8-10 percent is "unlikely to be highly noticeable" and thus unlikely to be the driving factor in "benefit buy downs" or decisions to drop coverage entirely.277 Generally speaking, small employers are more sensitive to the cost of health insurance. As described in the Ingenix Consulting actuarial report, Small groups tend to purchase lower cost, leaner plans than large groups. "Lean" plans shift more cost to the insured in the form of higher copays, deductibles, and coinsurance. Employees of small business also tend to pay a larger share of the premium. In this respect, the cost burden of the mandates will be somewhat greater for those whose insurance is provided through a small group employer.
…A 15% increase in premium cost, all else equal, is expected to cause more small groups than large ones to drop health insurance coverage. For the smallest employer groups, the owner who purchases group health insurance on behalf of the group may know more about the health conditions of the employees and their dependents. This may cause the employer to purchase a richer plan or to renew coverage when they might have otherwise terminated it.
Conversely, large groups could switch to a self-funded approach enabling them to avoid mandates if they wish and avoid premium tax. Given the small cost increase projected, this is not expected to occur. (Further discussion is available under Section IV: Social Impact #14).
271 Cremieux PY, Buchwald H, Shikora SA, et al. A study on the economic impact of bariatric surgery. Am J Manag Care. 2008; 14: 589-96.
272 Finkelstein EA, Brown DS. A cost-benefit simulation of coverage for bariatric surgery among full-time employees. Am J Manag Care. 2005; 273 Employee Retirement System of Texas. 2010. Developing a cost-neutral or cost-positive plan for providing bariatric surgery coverage for eligible employees in the group benefits program. A study and recommendation by the Employees Retirement System of Texas. 274 Hawkins SC, Osborne A, Finlay IG, et al. Paid work increases and state benefit claims decrease after bariatric surgery. Obesity Surgery 17, 275 Ewing BT, Thompson MA, Wachtel MS, Frezza EE. A cost-benefit analysis of bariatric surgery on the South Plains region of Texas. Obes Surg. Published online: 18 September 2010. 276 Ibid.
277 Appendix III: Ingenix Consulting Report.
Chapter 4. Gastric Bypass Chapter 4. Gastric Bypass 9. The impact of the mandated health benefit on cost-shifting between private and public payers of
health care coverage and on the overall cost of the health care delivery system in the state.
The overall cost to the health care delivery system, as defined for this report, is comprised of paid medical costs, cost-sharing, administration fees and profit/reserves. Ingenix Consulting projected an increase to the overall cost to the health care delivery system of $10,320,213 for the proposed bariatric surgery mandate. Of the overall cost, $8,019,571 is for paid medical costs, $481,174 for cost sharing, and $1,819,468 for retention. Cost sharing paid out-of-pocket by bariatric surgery patients account for 4.7 percent of the overall cost increase.
Cost-shifting between private and public payers of health care coverage generally occurs when formerly privately insured persons, after enrolling in a public program or becoming un- or underinsured, require and are provided health care services. Cost-shifting also occurs when a formerly publicly funded service becomes the responsibility of private payers, which can result following enactment of a health insurance mandate. This scenario does not apply since the state does not fund gastric bypass or bariatric surgery for members of private health plans.
Most persons formerly covered under private payers lose such coverage due to a change in employer, change in employment status, or when private payers discontinue offering health care coverage as an employee benefit or require employee contributions to premiums that are not affordable. For this scenario, if a person is eligible and enrolls into Medicare or Medicaid, gastric bypass or bariatric surgery may be covered with public dollars.
Given the low predicted increase of 0.61 PMPM in monthly premiums associated with this mandate, it is unlikely that the mandate, taken individually, would have an impact on cost-shifting between private and public payers.
Although cost-shifting related to health care does not appear likely to occur, it is possible that the public payers in general and the broader economy may benefit due to a decrease in lost work days. Ewing, et al. (2010) conclude that for the South Plains region of Texas the decrease in lost work days could generate benefits to society far greater than the costs of paying for surgery. The authors' conclusion was based on a modeling approach exploring labor income lost, jobs lost or not sustained, indirect business taxes lost and output lost to the costs related to bariatric surgery.278 Though limited by the lack of an adequate control group, a second study conducted in the United Kingdom also suggests that the mean weekly hours worked and engagement in paid work increase and state benefit claims decrease substantially following bariatric surgery.279 278 Ewing BT, Thompson MA, Wachtel MS, Frezza EE. A cost-benefit analysis of bariatric surgery on the South Plains region of Texas. Obes Surg. Published online: 18 September 2010. 279 Hawkins SC, Osborne A, Finlay IG, et al. Paid work increases and state benefit claims decrease after bariatric surgery. Obesity Surgery 17,

Source: http://www.publichealth.uconn.edu/assets/2011_ct_mandated_health_insurance_benefit_reviews.pdf