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    • District Court Interprets EKRAJanuary 7th, 2022

      “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018.  EKRA is codified at 18 U.S.C. § 220 and was described on HP&M’s …

    • CMS Hammers Final Nail in the Coffin of International Reference Pricing for DrugsDecember 29th, 2021

      We reported in August that CMS proposed to rescind the Most Favored Nation (MFN) drug pricing interim final rule issued in the latter days of the Trump regime.  Today, CMS finalized that proposal, effectively putting an end to the concept of international reference pricing as …

    • Ensuring the ACA Contraceptive Mandate Meets the Original Intention of CongressOctober 28th, 2021

      Having a hand in the FDA approval of important new prescription drugs is one of the things that makes our work at HPM so gratifying.  FDA approval is a significant hurdle to overcome, occurring only after scrupulous review of data collected over many years confirm …

    • PhRMA Sues Arkansas for Meddling in the Federal 340B Drug Discount ProgramOctober 7th, 2021

      Last week, we blogged about a growing list of drug manufacturers that have refused to follow a 2010 guidance issued by the Health Resources and Services Administration (“HRSA”), which permits 340B covered entities to contract with multiple pharmacies to dispense drugs to covered entity patients.  …

    • The 340B Showdown: HRSA Proceeds Towards Enforcement Despite LitigationSeptember 30th, 2021

      The 340B drug pricing program has been booming, according to the Health Resources and Services Administration (“HRSA”), the agency under the U.S. Department of Health and Human Services (“HHS”), which reported that discounted purchases totaled $38 billion in 2020, a 27% increase compared to 2019.  …

    • First North Dakota Quarterly Drug Price Transparency Reports Due in OctoberSeptember 13th, 2021

      Earlier this year, North Dakota enacted a prescription drug price transparency reporting law, HB 1032, that became effective on August 1, 2021. (See our summary here.) This new law requires prescription drug manufacturers to report the current wholesale acquisition cost (WAC) information for drugs sold …

    • PhRMA Code Revised in Response to OIG Special Fraud Alert on Speaker ProgramsAugust 24th, 2021

      On August 6, 2021, the Pharmaceutical Research and Manufacturers of America (PhRMA) announced the release of a revised PhRMA Code on Interactions with Health Care Professionals, which takes effect on January 1, 2022.  The PhRMA Code is a voluntary code of conduct focusing on the …

    • CMS proposes to Withdraw Trump Era Most Favored Nation (MFN) Drug Pricing RuleAugust 10th, 2021

      The Department of Health and Human Services (HHS) is proposing to rescind a Trump era rule that would have established a “most favored nation” (MFN) model to base Medicare Part B drug payment on international prices.  The Trump Administration rule had a troubled history.  The …

    • Infrastructure Bill Set to Delay Trump-era Rebate Rule to Raise CashAugust 4th, 2021

      On Monday August 2, 2021, the Senate took up for review H.R. 3684, the Infrastructure Investment and Jobs Act, following House passage of its version last month. Although the bipartisan bill largely deals with the nation’s transportation infrastructure, Section 90006 delays the so-called “rebate rule,” …

    • Maine and Nevada Update Drug Price Transparency LawsJuly 23rd, 2021

      Maine and Nevada previously enacted laws requiring drug manufacturers to report information about the pricing of their products. (See our coverage here and here). As summarized below, each state has recently updated their reporting requirements.  Both states’ new requirements will become effective in October 2021 …

    • Developments in State Prescription Drug Price Transparency LawsJune 4th, 2021

      While federal efforts to address prescription drug prices are debated, states have continued to pursue their own measures that require drug manufacturers and other entities in the drug supply chain to disclose information about pricing. (See our previous coverage of such state laws here, here …

    • Recent Developments in the Medicaid Drug Rebate ProgramJune 1st, 2021

      The past two weeks have seen two noteworthy developments relating to CMS’s Medicaid Drug Rebate Program (MDRP) regulations. 1.  PhRMA Sues CMS Challenging MDRP Rule Curbing Patient Assistance In December 2020, CMS published  a final rule making several changes to the MDRP regulations.  See our post …

    • AMPed up—again– over Medicaid Rebate False Claims Act allegationsApril 13th, 2021

      Earlier this month, the Department of Justice announced another settlement in a Medicaid Rebate False Claims Act (FCA) case.  In this case, United States ex rel. Streck v. Bristol-Myers Squibb Co., Civil Action No. 2:13-CV-7547 (E.D. Pa)  Bristol Myers Squibb (BMS) agreed to pay $75 …

    • HHS OIG Issues Advisory Opinion Regarding Free DrugsMarch 29th, 2021

      On March 24, 2021, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued its first advisory opinion of the year.  Advisory Opinion 21-01 addresses whether the provision of a specific drug at no cost by a pharmaceutical manufacturer to a …

    • Higher Medicaid Rebates Will Help to Fund COVID Rescue PlanMarch 15th, 2021

      Last Thursday March 11, the American Rescue Plan Act of 2021 was signed by President Biden. Out of the hundreds of pages of this COVID relief legislation, our pinpoint focus here is on several pages relating to Medicaid coverage and drug rebates.  The legislation requires Medicaid …