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    Health Care

    • 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 …

    • CMS Finalizes New Medicaid Rebate AgreementMarch 23rd, 2018

      In order for their outpatient drugs to be covered under Medicaid and Medicare Part B, drug manufacturers must enter into a National Drug Rebate Agreement (“Agreement”) with the Department of Health and Human Services. The Agreement requires the manufacturer to pay quarterly rebates to state …

    • CMS Finalizes National Coverage Determination for Next Generation Sequencing TestsMarch 20th, 2018

      On March 16, 2018, the Centers for Medicare and Medicaid Services (CMS) finalized a new National Coverage Determination (NCD) for Next Generation Sequencing (NGS) tests.  The granting of the new NCD resulted from the FDA – CMS Parallel Review of Foundation Medicine, Inc.’s FoundationOne CDx™ …

    • Oregon Jumps on the Drug Pricing Transparency BandwagonMarch 15th, 2018

      On March 13, 2018, Oregon became the latest state to enact a law focused on transparency in drug pricing (see our roundup of other recent state laws). The Prescription Drug Price Transparency Act, H.B. 4005, places new reporting requirements on drug manufacturers related to price …

    • New Jersey Finalizes New Limits on Pharmaceutical Manufacturer Gifts and Payments to PrescribersJanuary 17th, 2018

      As we previously reported, in October 2017, the New Jersey Attorney General and Division of Consumer Affairs issued a proposed rule in response to concerns about the amount of money being paid to prescribers in the state of New Jersey. On December 22, 2017, the …

    • 2017: A Banner Year for State Laws on Drug Pricing, Price Reporting, and DiscountingNovember 2nd, 2017

      Despite relative inaction on drug pricing at the federal level so far this year, 2017 has been a banner year for state legislation involving pharmaceutical pricing, price reporting, and discounting. Because it is becoming increasingly difficult to keep track of these recent laws, we thought …

    • CMS Abandons Pilot Program to Test Alternative Drug Payment Models Under Medicare Part BOctober 11th, 2017

      In early 2016, CMS issued a proposed rule to test new models for the payment of drugs and biologics under Medicare Part B (see our previous post here). The current statutory payment methodology for most drugs under Medicare Part B is the Average Sales Price …

    • HHS Will Delay 340B Final Rule Implementation to July 2018October 2nd, 2017

      On September 29, 2017, the Health Resources and Services Administration (“HRSA”) published, in the Federal Register, the Final Rule delaying the effective date regarding the methodology for calculating the 340B ceiling price (including the so-called penny pricing policy) and civil monetary penalties (“CMPs”) for knowing …

    • OIG Issues an Advisory Opinion on Providing Replacement ProductAugust 28th, 2017

      In an advisory opinion posted on August 25, 2017, the Office of the Inspector General of the Department of Health and Human Services (“OIG”) determined that enforcement action would not be taken against a drug manufacturer’s proposal to replace products that require specialized handling that …

    • HHS Proposes Longer Delays to Implementation of the 340B Final RuleAugust 21st, 2017

      On August 21, 2017, the Health Resources and Services Administration (“HRSA”), the federal agency responsible for overseeing the 340B Drug Discount Program, published in the Federal Register a Notice of Proposed Rulemaking (“NPRM”) that would delay until July 1, 2018 the implementation of the Final …

    • Implementation of 340B Final Rule Postponed Until October 1, 2017May 19th, 2017

      Today the Health Resources and Services Administration (“HRSA”), the federal agency responsible for overseeing the 340B Drug Discount Program, published in the Federal Register a rule delaying until October 1, 2017 the implementation of a final regulation establishing the methodology for calculating the 340B ceiling …

    • 340B Rule Sinks Deeper Into Regulatory FreezeMarch 21st, 2017

      A final regulation implementing the 340B Drug Discount Program has been caught in the regulatory freeze. In the waning days of the Obama Administration, the Health Resources and Services Administration (“HRSA”) of HHS issued a final regulation describing the methodology for calculating the 340B ceiling …

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