Category Archives: Corporate Compliance

Enforcement Trend: Patient Assistance Programs

binoculars-clipart-as1859Multiple pharmaceutical companies have disclosed the receipt of subpoenas from various U.S. Attorney’s offices, including Massachusetts and the Southern District of New York, related to the companies’ patient assistance programs. Patient assistance programs also have been the subject of recent Congressional inquiries related generally to the increasing price of certain prescription drugs.

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Filed under Corporate Compliance, Government Enforcement

Final Medicaid Drug Rebate Program AMP Rule: Some Technical Highlights

We reported yesterday that the Centers for Medicare & Medicaid Services (CMS) Final Average Manufacturer Price (AMP) Rule (the “Final Rule”) was released and will be published in the Federal Register on February 1.  If you are still reading, despite the fact that we included “Technical Highlights” in today’s title, we will assume a certain level of familiarity with the Medicaid Drug Rebate Program in our discussion below.  However, although the issues addressed in the Final Rule are technical, the business implications are very real, and the Final Rule is significant to all manufacturers with marketed drug products participating in the Medicaid Drug Rebate Program (or who hope to participate someday).

Those of you who have been anxiously awaiting a final AMP rule for years now will be pleased to learn that some long-standing questions raised by CMS’s controversial 2012 proposed AMP rule have been answered (and, of course, some new questions have been raised).  Some highlights of the Final Rule, in no particular order:

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Filed under 340B, Compliance, Corporate Compliance, Coverage and Reimbursement, Fraud and Abuse, Government Pricing, Health Care, Health Reform, Medicaid, The Affordable Care Act

Final MDRP AMP Rule is Out! Will be Effective on April Fools Day 2016. (No joke.)

If you were looking for something fun to read while snow shuts down our nation’s capital tomorrow, the Centers for Medicare & Medicaid Services (CMS) just released the long-awaited Final Medicaid Drug Rebate Program Rule on Average Manufacture Price (AMP) (et al.)!  The publication of this Final AMP Rule follows the 2012 publication of CMS’s highly controversial proposed policies implementing various changes to the Medicaid Drug Rebate Program enacted under the Affordable Care Act.  This rule has significant potential to impact drug manufacturers’ calculations and policies regarding the Medicaid Drug Rebate Program and pricing more generally, and should be carefully reviewed by all interested parties.   It is being issued as a final rule with comment period.

We are currently reviewing the 657 pages of material, and plan to provide more substantive commentary in a subsequent post.  For those of you playing along at home, the rule is expected to appear in the February 1, 2016, Federal Register, and comments are expected to be due by 5:00 PM Eastern April 1, 2016 (which is also the effective date of the rule).  Separately, State Medicaid Agencies must comply with certain rule requirements by submitting a State Plan Amendment (SPA) by June 30, 2017 to be effective no later than April 1, 2017.

Stay tuned…

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Filed under 340B, Corporate Compliance, Coverage and Reimbursement, Fraud and Abuse, Government Pricing, Health Reform, Medicaid, The Affordable Care Act

OIG Releases FY2016 Work Plan: Areas to be Reviewed Include SNFs, Drug Pricing, HIPAA

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) released this week its FY2016 Work Plan (Work Plan). The OIG Work Plan summarizes new and ongoing OIG reviews of various HHS programs and activities, which are selected based on a number of factors such as mandatory OIG review requirements; requests from Congress, HHS management, or the Office of Management and Budget (OMB); and previously identified issues. Some key, new OIG reviews in the FY2016 Work Plan include the following:

Medicare Payments

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Filed under Corporate Compliance, DHHS OIG, Fraud and Abuse, OIG Guidance

Court Holds Corporate Integrity Agreement May Be Basis for Reverse False Claim Liability

This week, a federal district court denied Cephalon Inc.’s (Cephalon) motion to dismiss a third amended complaint filed under the False Claims Act (FCA) by three qui tam relators in United States ex rel. Boise v. Cephalon, Inc. The motion to dismiss relates to claims made by the whistleblowers under 31 U.S.C.§ 3729(a)(1)(G) (“. . . knowingly makes, uses, or causes to be made or used, a false record or statement material to an obligation to pay or transmit money or property to the Government, or knowingly conceals or knowingly and improperly avoids or decreases an obligation to pay or transmit money or property to the Government . . .”). Specifically, the relators allege that Cephalon promoted its drugs Provigil and Nuvigil for off-label purposes and paid unlawful kickbacks to health care professionals, and failed to report this conduct in violation of its 2008 corporate integrity agreement (CIA) with the U.S. Department of Health and Human Services Office of Inspector General (OIG).

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TREND WATCH: GOVERNMENT USE OF DATA ANALYTICS TO IDENTIFY HEALTH CARE FRAUD

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Data analytics is not a new concept within the health care industry. However, as data analytics tools become more accessible, government interest in using data analytics to detect health care fraud continues to increase. Government investigators also have been vocal in informing the health care industry that this powerful tool will continue to be used.

For example, the House Ways and Means Subcommittee on Oversight recently held a hearing on the government’s use of data analytics to combat health care fraud. Testifying witnesses included a representative from the Centers for Medicare and Medicaid Services (CMS), who discussed the use of data analytics to identify excluded individuals. A representative from the U.S. Department of Health and Human Services Office of Inspector General (OIG) discussed the use of data analytics by the agency and the Medicare Fraud Strike Force for prospective and investigative purposes.

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Resource Launch: Key Considerations for Health Care Fraud Government Investigations/Inquiries

Cooley is excited to release a new resource for health care and life sciences companies: Key Considerations for Health Care Fraud Government Investigations/Inquiries. This quick reference documents provides a list of steps that companies should consider taking before a government investigation/inquiry occurs, and key steps to take if a becomes aware of a government investigation/inquiry.

Visit our website to learn more about Cooley’s Health Care & Life Sciences Regulatory practice.

Investigations_Page_1

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Filed under Compliance, Cooley Alerts, Corporate Compliance, Fraud and Abuse, Government Enforcement, Health Care, Litigation, Medical Devices