Fraud by the numbers

FRAUD BY THE NUMBERS FRAUD BY THE NUMBERS Utah Medicaid Fraud Control Unit Utah Attorney General's Office MFCU Director Robert E. Steed 5272 South College Drive #200 Murray, Utah 84123 (801)281-1259

MEDICAID FRAUD CONTROL UNITS Medicaid Fraud Control Units • Created by Federal Law to protect Medicaid resources and those who receive care under the • Oversight by Office of Inspector General or OIG ▫ Relationship to Centers of Medicaid and Medicare ▫ Independence from Medicaid Finance at Department ▫ Federal Matching Annual Percentage ("FMAP") ▫ Single Identifiable Entity within Utah Attorney General's Office. Medicaid Program Summary • Program for the Poor and Disabled who qualify • Federal Matching Percentage. • State Run but federally regulated. • 2 billion dollar budget in 2015. • Providing access to quality care while enforcing • Independence of Audit function – State OIG ▫ Federal Law Requirements:  Conduct a Statewide program for investigating and prosecuting (or referring) violations of all applicable State laws pertaining to fraud in the administration of the Medicaid Program.  Provision of medical assistance  Activities of providers of medical assistance under the State Medicaid plan. Federal Requirements • The Unit will review complaints alleging abuse or neglect of patients in health care facilities receiving payments under the State Medicaid Plan. • Review complaints of the misappropriation of patient's private funds in such facilities. • If review indicates substantial potential for criminal prosecution, the unit will investigate or refer to proper authority.

Abuse and Neglect

MEDICAID FRAUD DETECTION Regular Police Work
MFCU Police Work

National
• Billing Fraud • Global Qui Tam Lawsuits ▫ Services not Rendered • Local Lawsuits ▫ Services not Necessary • Pharmaceutical Companies ▫ Services billed at a level that • Large National Entities. misrepresents nature and • Off label marketing quality. (Up coding) • Average Wholesale and Best ▫ Quality of Care ▫ Financial exploitation • Contaminated products or non ▫ Illegal kickbacks and FDA approved products • Repackaged and resold drugs. The Role of Auditors in Criminal Investigations. • By federal laws MFCU's must employ a senior auditor with experience in health care related programs. • In house audit staff are a rarity in law • Law enforcement agencies which employ auditors realize soon of the skill set and efficiency of using trained professionals to assist in financial investigations. Problem Solving Capacity • Since 2006, the MFCU has recovered more than 90 million dollars from local and global case lawsuits which required extensive data analytics and good old fashioned … Chin Down… Elbows In. Audit work. OFF LABEL MARKETING Marketing drugs to physicians in a manner inconsistent with FDA approved Label. Off Label Marketing • FOOD, DRUG & COSMETIC ACT ▫ 21 USC 355 - No Person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) is effective with respect to said drug. ▫ The following acts and the causing thereof are hereby  (a)introduction into interstate commerce of any food, drug, device or cosmetic that is adulterated or misbranded.  The introduction or delivery for introduction into interstate commerce of any article in violation of …21 USCS 355. Pharmaceutical Fraud • Off Label Marketing Litigation ▫ Proving that drugs manufactured and approved by the F.D.A. were marketed to physicians for off label prescriptions. ▫ Off-label prescribing is not illegal. ▫ Off label marketing is illegal. ▫ The task is proving that the manufacturer knowing caused an FDA approved drug to be marketed for uses which are outside the FDA approved indications. Pharmaceutical Fraud • Evidence of off-label marketing ▫ Qui Tam Relator or Whistleblower Information ▫ Marketing memos ▫ Call Notes ▫ Data analytics:  Surges in prescribing patterns following marketing  Algorithms demonstrating off label prescribing for diagnosis outside of approved indications. Off Label Marketing "On the one hand, it is unlawful for a manufacturer to introduce a drug into interstate commerce with an intent that it be used for an off-label purpose… and a manufacturer illegally "misbrands" a drug in the drug's labeling includes information about its unapproved uses." Examples of Utah Off-Label Cases • Zyprexa –Eli Lilly – $24,000,000 • Risperdal – Janssen – $5,022,417.33 • Seroquil –Astra Zeneca – $4,750,000 • Avandia – Glaxo Smith Kline – 10,000,000 Average Wholesale Price • Longest Standing Allegation of Pricing or Marketing Fraud. • Most Litigated and most problematic area of pricing or marketing fraud. • Prior federal laws attempted to base drug reimbursement on a formula intended to pay drug manufactures based on the estimated acquisition cost of a drug plus a reasonable dispensing fee or the usual and Customary Charge to the General Public. Average Wholesale Price • Drug Manufacturers wish to maintain trade secrets such as the actual ingredient cost of their medication. • Accordingly, most states including Utah used "Average Wholesale Price" as the benchmark for the Best Estimate of Price. • Pharmaceutical companies reported pricing information to a Price Reporting Compendia which the States used to determine AWP. Average Wholesale Price • Average Wholesale Price – was not defined by law and became like a "sticker price" on a new car at an auto dealership. • Pharmaceutical companies used this "ambiguity" to "market to the spread" • The "spread" meaning the difference between the wholesale or acquisition cost and the price purposely falsely reported by the manufacturer to Medicaid for reimbursement. Conscious Manipulation • "The current formula for reimbursement to the health care provider involves the AWP. In a non-capitated environment, the gain to the provider lies in the spread between the acquisition cost and the AWP. It becomes apparent that we need to increase the AWP to $90/gm from the current $75/gm to increase the spread above that of our competitors. This will further incent providers to choose our product." More Conscious Manipulation • "Currently, MD practices can take advantage of growing disparity between our drug's list price/Average Wholesale Price and the actual acquisition cost when obtaining reimbursement. … If acquisition price of our drug is close to list price, MD's financial incentive for selecting our brand is largely diminished." Marketing the Spread Scope of the Spread (data from 2008) Reported AWP Market Price
Amikacin Sulfate Cyclophosphamide Albuterol Sulfate Consequences of the Spread • States pay too much for medication. • Market no Longer Providing Incentive to Prescribe the Most Cost Effective Drug. • Physicians prescribing for drugs administered in hospitals, etc, may be influenced by spread in prescribing decisions. Example
Same type Drug Reported Price Actual Price
"Spread"
By different
generic
manufacturers
Drug A
Which generic drug under this system would the pharmacy purchase to put on its shelf? Role of Auditors • Auditors have specialized knowledge and skill set to perform the work needed to gather and compile, organize and sift numerical and other data. • Auditors are typically not befuddled by numbers and spreadsheets… they Thrive on Them! • Auditors are problem solvers and devise algorithms and data pulls to prove the elements of our case. Role of Auditors • The MFCU utilizes auditors to trace bank • Prove misappropriation of funds. • Trace assets for preservation. • Teach judges and juries about their processes for gathering and interpreting evidence. • Auditors help us be realistic in assessing our Auditors are Awesome.

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