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    • Medicaid “Right Rebate” Provisions Clear CongressApril 5th, 2019

      The Senate on Tuesday passed H.R. 1839, a bill of Medicaid amendments that included new penalties for mis-categorizing a drug under the Medicaid Drug Rebate Program (MDRP).  The bill already cleared the House on March 25, and is now headed to Donald Trump for signature.  …

    • Laboratories Beware of EKRAMarch 5th, 2019

      On October 24, 2018, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (“SUPPORT”) for Patients and Communities Act was signed into law (the Act’s text is available here).  The SUPPORT Act includes a number of provisions to address the ongoing opioid crisis, such …

    • Telemedicine Lunch-and-Learn at HP&MFebruary 25th, 2019

      Hyman, Phelps & McNamara, P.C. (HP&M) is proud to announce that two associates, Serra Schlanger and Rachael Hunt, will be hosting a program on telemedicine for FDLI’s New to Food and Drug Law Group (NFDL). Telemedicine: Key Issues to Consider When Advising Clients, will take place …

    • OIG Proposed Safe Harbor Revisions Take Aim at Formulary Rebates, Volume-Based PBM Administrative FeesFebruary 1st, 2019

      Yesterday the U.S. Department of Health and Human Services (HHS) Office of the Inspector General (“OIG”) released a proposed rule to put into practice an idea floated in HHS’ May 2018 Blueprint for lowering drug prices:  eliminating discount safe harbor protection for manufacturer rebates offered …

    • Pharmaceutical Manufacturers Must Submit 340B Ceiling Prices Starting in the First Quarter of 2019January 23rd, 2019

      Beginning February 15, drug manufacturers will have a new price to report to the Federal government: 340B ceiling price.  Under Section 340B of the Public Health Service Act, a manufacturer of covered outpatient drugs, as a condition of having its drugs be eligible for federal …

    • AdvaMed Updates Code of EthicsJanuary 17th, 2019

      On January 9, 2019, the Advanced Medical Technology Association (AdvaMed) announced updates to its “Code of Ethics on Interactions with Health Care Professionals” (Code).  The Code was last updated in 2008; the newest updates will become effective on January 1, 2020. The Code includes new sections …

    • Federal Court Invalidates CMS’ Reduction of Medicare Hospital Outpatient Payment Rates for 340B DrugsJanuary 1st, 2019

      On December 27, 2018, the Federal District Court for the District of Columbia enjoined the Centers for Medicare and Medicaid Services (CMS) from implementing a regulation setting reimbursement for hospital outpatient payment rates for 340B drugs at Average Sales Price (ASP) minus 22.5%. A brief history: …

    • CMS Proposes Rule to Reduce Drug Costs Under Medicare Part D and Medicare AdvantageDecember 4th, 2018

      On November 30, CMS published in the Federal Register a proposed rule on Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses. This proposal is the latest in a series of CMS actions to implement the HHS Blueprint to Lower …

    • HRSA: No Further Delay of 340B Ceiling Price and Civil Monetary Penalties RuleNovember 30th, 2018

      On November 6, we reported that the Health Resources and Services Administration of the Department of Health and Human Services (HHS) had proposed to move up the effective date of its 340B program ceiling price and civil monetary penalties regulation from July 1 to January …

    • HRSA Releases Proposed Rule to Move Up Effective Date of 340B Final RuleNovember 6th, 2018

      On November 2, 2018, the Health Resources and Services Administration (“HRSA”) released a proposed rule to move up to January 1, 2019 the effective date of implementation and enforcement of the previously delayed final rule implementing the 340B Drug Discount Program (“Final Rule”). The Final …

    • Congress Expands Sunshine ReportingOctober 9th, 2018

      Last Wednesday, October 3, a wide-ranging opioid bill cleared its last legislative hurdle by passing the Senate, and is expected to be signed by the President in the near future. H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (“SUPPORT”) for Patients …

    • Third Circuit Affirms False Claims Act Dismissal Based on Reasonable InterpretationAugust 22nd, 2018

      In United States of America ex rel Streck v. Allergan Inc., a federal False Claims Act (FCA) case alleging that several pharmaceutical manufacturers knowingly calculated false Average Manufacturer Prices (AMPs) that affected their Medicaid rebate payments, the U.S. Court of Appeals for the Third Circuit …

    • Nevada Department of Health and Human Services to Exercise Enforcement Discretion for Required Reports under Drug Pricing Transparency LawJune 26th, 2018

      As we previously reported, Nevada enacted a law on June 15, 2017 addressing drug prices. S.B. 539 imposed new reporting requirements on pharmaceutical manufacturers and pharmacy benefit managers (“PBMs”) related to diabetes treatments and health care provider payments (also see related posts here and here). …

    • Connecticut Becomes Seventh State to Enact Drug Price Transparency LawJune 6th, 2018

      With the enactment of Public Act 18-41 on May 31, 2018, Connecticut joined the growing list of states (see our posts here and here) requiring drug manufacturers to submit reports on price increases. Three different reporting requirements are imposed on manufacturers under the law. First, …

    • Fifth Delay for 340B Final Rule ImplementationJune 4th, 2018

      On June 1, 2018, the Health Resources and Services Administration (“HRSA”) released a final rule delaying the effective date of implementation and enforcement of the previously issued final rule implementing the 340B Drug Discount Program (“Substantive Final Rule”). The Substantive Final Rule, which was originally …