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Pharmaceutical Manufacturers and Healthcare Leaders cite Fraud and Abuse Laws as Obstacle to Value-Based Arrangements

March 15, 2017 | Blog | By Theresa Carnegie, Lauren Moldawer

As the healthcare industry moves towards value-based purchasing, pay-for-performance, and other payment reform models, industry leaders have identified federal fraud and abuse laws as a barrier to full implementation of such models.
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OIG Releases FY 2016 Statistical Data About Medicaid Fraud Control Units

March 9, 2017 | Blog | By Samantha Kingsbury

Earlier this week, the Office of Inspector General for the Department of Health and Human Services (“OIG”) posted its fiscal year ("FY") 2016 data about Medicaid Fraud Control Units (“MFCUs”) across the country.
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Registration for the 2017 Mintz/ML Strategies Pharmacy Industry Summit is Open! (April 5-6, 2017)

March 6, 2017 | Blog | By Theresa Carnegie

The pharmacy industry continues to be under scrutiny from all angles.  As legislative, agency, and enforcement priorities take shape under the new administration, the industry is faced with what seems like daily developments in terms of policy updates, legislation, and potential regulation.
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Fourth Circuit Permits DOJ to Reject an FCA Settlement, But Punts Decision on Statistical Sampling

February 22, 2017 | Blog | By Brian Dunphy, Laurence Freedman

In a closely watched False Claims Act (“FCA”) case, the Fourth Circuit Court of Appeals decided that the Department of Justice (“DOJ”) has an unreviewable right to object to a proposed settlement agreement between a relator and a defendant when the Government has declined to intervene in the case.
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OIG Publishes Online Portfolio Highlighting its Body of Work on Drug Pricing and Reimbursement

February 21, 2017 | Blog

For several years now, the public outcry over the issue of drug pricing and reimbursement has increased in frequency and fervor. At least one government agency wants you to know that it has been listening and wants to help provide the information necessary to forge a solution.
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Another Court Agrees That A Difference Of Opinion On Medical Necessity Is Insufficient to Show Falsity Under the False Claims Act

February 14, 2017 | Blog | By Samantha Kingsbury, Laurence Freedman

Last month, the U.S. District Court for the District of Utah joined the AseraCare court and others in finding that a relator cannot successfully allege violations of the False Claims Act (“FCA”) based on a purported lack of medical necessity unless there is an objective standard articulated by Medicare.
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FDA’s Enforcement Priorities Likely to Change in 2017 and Other “Unknowable Knowns”

January 17, 2017| Blog|

Grassley Continues To Press CMS on Medicaid Drug Rebate Classifications: What Will Be the Fallout?

January 12, 2017 | Blog

Back in early October, we were all transfixed by the announced Mylan settlement with the U.S. Department of Justice (DOJ) over Mylan’s alleged underpayments of Medicaid Drug Rebates for the EpiPen.
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Health Care Enforcement Review and 2017 Outlook: Significant Health Care Fraud and Abuse Civil Settlements and Criminal Resolutions

January 10, 2017 | Blog | By Brian Dunphy, Karen Lovitch, Kevin McGinty

In this final installment of our Health Care Enforcement Review and 2017 Outlook series, we analyze health care enforcement trends gathered from 2016 civil settlements and criminal resolutions of health care fraud and abuse cases. Behind the headlines covering enormous recoveries in 2016, several themes are apparent.
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Health Care Enforcement Review and 2017 Outlook: Significant Regulatory Developments

January 6, 2017 | Blog | By Laurence Freedman, Karen Lovitch

While 2016 marked one of the least productive years in the history of Congress, the same cannot be said of health care enforcement and regulatory agencies. Perhaps motivated by the impending change in administration, these agencies promulgated a number of notable regulations in 2016.
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Health Care Enforcement Review and 2017 Outlook: Major Case Developments

January 5, 2017 | Blog | By Ryan Cuthbertson

Today, my colleagues Laurence Freedman, Samantha Kingsbury, and Karen Lovitch released the latest in our ongoing series reviewing health care enforcement activities in 2016 and their impacts looking forward to 2017.
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Health Care Enforcement Review and 2017 Outlook: FDA's Wide-Ranging Activities

January 4, 2017| Blog|

Health Care Enforcement Review and 2017 Outlook: Yates Memo in Action

January 3, 2017 | Blog | By Eoin Beirne

Happy New Year! As we kick off 2017, our Health Care Enforcement Defense team brings you its annual review of key government policies, regulations, and enforcement actions in 2016, and the impact these trends are expected to have on enforcement in the year ahead.
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At Long Last, OIG Issues Final Rule for Beneficiary Inducement Safe Harbors

December 12, 2016 | Blog | By Carrie Roll

More than two years since issuing the proposed rule, the HHS Office of the Inspector General (OIG) issued the long-awaited and highly anticipated final rule (the Final Rule) that provides amendments to the Anti-Kickback Statute (AKS) regulatory safe harbors and adds protections for certain payment practices and business arrangements under the beneficiary inducement provisions of the Civil Monetary Penalty Law (CMP).
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2017 OIG Work Plan: For Medicare Plans

November 16, 2016 | Blog | By Tara E. Dwyer

Last week, the OIG posted its Work Plan for 2017.  In it, the OIG announced many goals touching on programs including, but not limited to, Medicare, Medicaid, Insurance Marketplace (Health Exchanges), Indian Health Service, TANF and Head Start.  Below are some of the OIG’s action items that Medicare Advantage and Part D plans should be aware of.
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FCA Settlement Involves Waiver of Medicare Coinsurance Amounts

October 25, 2016 | Blog | By Karen Lovitch

The waiver of copayments, coinsurance, and deductibles owed by patients treated by out-of-network laboratories and other providers is a hot topic in the health care industry.
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Reminder: Pharmaceutical Industry Enforcement Webinar - Wednesday, October 26

October 24, 2016 | Blog

Pharmaceutical industry enforcement has been one of the hottest topics in the news in the past month. Last week, Ellyn Sternfield and Rodney Whitlock were quoted by cnbc.com regarding the recent Mylan settlement.
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Five Things to Know About the Mylan EpiPen "Settlement" - What It Is and What It Isn't

October 14, 2016 | Blog

Our eyebrows were raised by Mylan’s October 7, 2016 announcement that it had reached a $465 million “settlement” with the United States Department of Justice (DOJ) and “other government agencies” over its Medicaid Drug Rebate obligations for EpiPen. 
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Join Us For A Webinar On October 26th Discussing Pharmacy Industry Enforcement

October 6, 2016 | Blog | By Brian Dunphy

Please join Mintz Levin for a webinar discussing health care fraud enforcement in the pharmacy and pharmaceutical industry on October 26, 2016 at 1 pm (ET). My colleagues Theresa Carnegie, Larry Freedman, and Ellyn Sternfield, members of Mintz Levin’s Health Law and Health Care Enforcement Defense practices, will discuss enforcement trends facing the industry.
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Billing Companies Beware – OIG Signals a Crack Down on Fraud and Abuse at All Levels

September 28, 2016 | Blog | By Carrie Roll

In an unprecedented administrative action, the U.S. Department of Health & Human Services Office of the Inspector General (“HHS-OIG”) penalized a medical billing company for preparing and submitting claims to Medicare for diagnostic tests that were never conducted.
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