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    • Gun Violence Reduction Law Further Extends Moratorium on Trump-Era Rebate RuleJune 27th, 2022

      We have blogged before (for example, here and here) on amendments to the Federal health care program antikickback law safe harbor regulations that were finalized by the Trump Department of Health and Human Services in November 2020.  If and when implemented, the amendments will likely …

    • Supreme Court Finds CMS’ Reduction of Medicare Hospital Outpatient Payment Rates for 340B Hospitals was Not Authorized by StatuteJune 16th, 2022

      In 2017, the Centers for Medicare & Medicaid Services (“CMS”) issued a final rule to significantly decrease the rate the government will reimburse 340B hospitals in 2018 for outpatient prescription drugs from average sales price (“ASP”) plus 6% to ASP minus 22.5%.  82 Fed. Reg. …

    • CMS Releases Guidance on Multiple Best Price Reporting for Value Based ArrangementsApril 1st, 2022

      In January 2021, we reported on a CMS rule that, among other things, revised the Medicaid rebate best price regulation to remove impediments to value-based purchasing (VBP) arrangements in Medicaid. The rule, which will go into effect on July 1, 2022, defined a VBP is …

    • HP&M’s Sophia Gaulkin to Present on Changes to State Drug Pricing Transparency RequirementsMarch 17th, 2022

      Hyman, Phelps & McNamara, P.C. is pleased to announce that Sophia Gaulkin will be presenting and speaking on an expert panel at Informa Connect’s Drug Pricing Transparency Congress, which is being held virtually and in-person in Philadelphia on March 28-29, 2022. Ms. Gaulkin’s presentation on Changes …

    • 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 …