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In the first new guidance document from FDA in several years specific to the subject of direct-to-consumer (DTC) promotion of prescription drugs and biological products, the Agency is recommending that companies take additional steps to ensure that quantitative efficacy or risk information does not convey inaccurate information and does not have the potential to confuse consumers. The draft guidance defines quantitative efficacy and risk information as “information that numerically addresses the likelihood or magnitude of a drug’s effectiveness or risks.” FDA’s advice on how to most clearly share this type of information should be considered by companies when developing any form of DTC promotional media, whether they are digital, broadcast, in traditional print format, or otherwise.
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The Department of Health and Human Services Office of the Inspector General (“OIG”) has issued an Advisory Opinion regarding a surgical device and wound care product manufacturer’s proposal to offer its hospital customers who purchase a suite of three joint replacement products a warranty program covering the Product Suite.
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HHS Continues the “Sprint to Coordinated Care”

September 28, 2018 | Blog | By Daryl Berke

On August 27, 2018 the Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS) issued a request for information (RFI) seeking comment on the anti-kickback statute (AKS) and the beneficiary inducement prohibition to the civil monetary penalties (CMP) as potential barriers to coordinated and value-based care. The August 27 RFI was the second RFI issued as part of HHS’s “Regulatory Sprint to Coordinated Care,” an ongoing effort to accelerate the transition from fee for-service to a value-based system that emphasizes care coordination.
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The 2014 Overpayment Rule is Vacated: How We Got Here and Key Takeaways

September 26, 2018 | Blog | By Bridgette Keller

Medicare Advantage Organizations (MAOs) have been hailing a federal judge’s recent ruling to vacate the 2014 Overpayment Rule. But, how did we get here? And what does it really mean for MAOs?
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The Tenth Circuit Court of Appeals has issued a significant decision, finding that a physician’s medical judgment about the medical necessity of heart procedures can be “false or fraudulent” under the federal False Claims Act (FCA). 
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Recently the U.S. Department of Justice (DOJ) issued a statement that it had intervened in a False Claims Act (FCA) case against Insys Therapeutics, Inc. and consolidated five separate qui tam cases into one case, U.S. ex rel Guzman v. Insys Therapeutics, Inc., filed in the U.S. District Court for the Central District of California.
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The all-too-common story of a healthcare company declaring bankruptcy in the face of aggressive Medicare recoupment actions before the company even has a hearing before an Administrative Law Judge (ALJ) may get a new ending – at least in the Fifth Circuit.
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Last week, the U.S. Attorney’s Office for the District of Massachusetts announced that it had entered into an agreement with a Massachusetts-based medical device manufacturer to settle allegations that the Company had violated the False Claims Act by purchasing lavish meals for physicians to induce them to use heart pumps manufactured by the Company.
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Are HCT/Ps a Dark Spot in the Sunshine Act Requirements?

March 7, 2018 | Blog | By Benjamin Zegarelli

On February 22, the Wall Street Journal published an article about the tissue graft manufacturer MiMedx Goup, Inc. and its failure to report payments to physicians under CMS’s Open Payments Program established by the Centers for Medicare & Medicaid Services under the Patient Protection and Affordable Care Act (P.L. 111-148, Sec. 6002, amending Social Security Act Sec. 1128G), also known as the Physician Payments Sunshine Act (PPSA).
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The Department of Justice (DOJ) recently intervened in a False Claims Act (FCA) case that raises a variety of interesting allegations, including payment of kickbacks by a compounding pharmacy to contracted marketing companies in the form of percentage-based compensation, to TRICARE beneficiaries in the form of co-payment waivers, and to physicians who submitted prescriptions without seeing patients.
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Mintz’s Health Care Enforcement Defense Group recently published its most recent Health Care Qui Tam Update. This Update analyzes the 47 health care-related qui tam cases unsealed in August and September 2017.
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The Health Policy Commission’s Annual Cost Trends Hearings

November 1, 2016 | Alert | By Steven Baddour, Daniel Connelly, Julie Cox, Daria Niewenhous, Stephen Weiner, Maxwell Fathy, Elena Horvit, Parnia Zahedi

The Massachusetts Health Policy Commission conducted its fourth annual Cost Trends Hearing on October 17 and 18, 2016, under the requirements of Massachusetts’s 2012 health care reform legislation (“Chapter 224”).
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As stakeholders and watchers of the expansive field of regenerative medicine likely are aware, earlier this year a study published in the peer-reviewed journal Cell Stem Cell reported on the growth of so-called stem cell clinics operating in the U.S.
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Deciphering the Final AMP Rule – Key Provisions Impacting Pharmacies, PBMs, and Manufacturers

February 10, 2016 | Advisory | By Theresa Carnegie, Ellyn Sternfield, Lauren Moldawer

In late January, the Centers for Medicare & Medicaid Services (“CMS”) released the much anticipated Covered Outpatient Drugs Final Rule with Comment (the “AMP Final Rule”).
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Drug Costs, Risk Adjustment Drive Q2 Health Insurance Rate Increases

January 26, 2016 | Advisory | By Julie Cox, Stephen Weiner, Sasha Dudding

The Massachusetts Division of Insurance (DOI) recently held a two-day hearing on rate changes proposed by Massachusetts health insurance plans to be effective for the second quarter of 2016 (Q2).
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On November 12th and 13th, the Food and Drug Administration hosted genome scientists from across the nation at its campus in White Oak, Maryland.
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Recent Developments in Massachusetts Health Policy

October 23, 2015 | Alert | By Julie Cox, Sasha Dudding, Stephen Weiner

Building on the momentum of early October hearings on the state’s growing health care expenditures, the Health Policy Commission (HPC), the Joint Committee on Health Care Financing, Governor Charlie Baker, and others spent the past two weeks crafting new policies for the industry and its consumers.
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CMS Releases Final Rule for the Medicare Shared Savings Program

June 9, 2015 | Alert | By Dionne Lomax, Daria Niewenhous

On June 4, 2015, the Center for Medicare & Medicaid Services ("CMS") released the highly anticipated Final Rule ("Final Rule") updating the Medicare Shared Savings Program ("Shared Savings Program").
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Over a Decade in the Making: CMS Releases Long-Awaited Medicaid Managed Care Rule

June 5, 2015 | Advisory | By Susan Berson, Ellyn Sternfield, Pamela Kramer, Bridgette Keller, Lauren Moldawer

On May 27, 2015, the Centers for Medicare and Medicaid Services (“CMS”) published a 653-page proposed rule affecting the thirty-nine states (plus the District of Columbia) that use managed care organizations (“MCOs”) to administer their Medicaid benefits.
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FTC Says New York’s Medicaid Redesign Program May Promote Anticompetitive Behavior

May 4, 2015 | Advisory | By Dionne Lomax, Stephen Weiner, Nili Yolin

In an April 22, 2015 letter to the New York State Department of Health (DOH), the Federal Trade Commission (FTC) cautioned that part of the State’s Medicaid reform program may sanction anticompetitive behavior.
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