K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
On August 23, Johnson & Johnson (J&J) issued a written notice to disproportionate share hospitals that participate in the prescription drug discount program established under section 340B of the federal Public Health Service...more
The Supreme Court of the United States issued its highly anticipated ruling in a pair of cases challenging the long-standing Chevron doctrine on June 28, 2024. Foreshadowed by decisions in recent years slighting Chevron, it...more
The Affordable Prescriptions for Patients Act (APPA) of 2023 unanimously passed the Senate on July 11, 2024. The APPA was first introduced to the House on January 30, 2023 by Representative John Cornyn (R-Tx), with the aim of...more
Recent history of Congress's performance as a legislative body has been, to be kind, mixed, and a great many bills, resolutions, and other activities have appeared to be more for show than to accomplish anything worthwhile. ...more
Recently the Senate passed S.150 entitled the Affordable Prescriptions for Patients Act. Those paying attention might recall that Senator Cornyn (R-TX) introduced this bill (joined by Senator Blumenthal (D-CT) and seven other...more
Recently, Venable's Government Division offered its general thoughts on the fallout from the Supreme Court's reversal of the long-standing Chevron deference principle. Here, the FDA Practice Group offers some of its own...more
Section 340B of the Public Health Service Act has grown significantly since its enactment in 1992 – both in the number of covered entities eligible to participate and in the volume of drugs purchased through the program. The...more
The Federal No Surprises Act (“NSA”) was signed into law on December 27, 2020, as part of the Consolidated Appropriations Act of 2021. Since its enactment, the NSA has been supplemented on two occasions by regulations which...more
If you work for or represent group health plans or issuers of group health plans, it is important that you take a look at the contracts they have with health care providers before the end of 2023. The Internal Revenue Code...more
This new legislation supports the Health Resources and Services Administration ("HRSA") modernization initiative announced in March, including several actions to strengthen accountability and transparency in the Organ...more
Employers should be aware that the No Surprises Act has an impact on the maximum-out-of-pocket ("MOOP") limit for annual cost-sharing under the Affordable Care Act ("ACA") and facility fee transparency. The new set of...more
The Centers for Medicare & Medicaid Services (CMS) released the Hospital Outpatient Prospective Payment System: Remedy for 340B-Acquired Drugs Purchased in Cost Years 2018-2022 Proposed Rule on July 7, 2023. CMS has published...more
On June 27, 2023, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a final rule amending OIG’s civil money penalty (CMP) regulations implementing the 21st Century Cures Act...more
On March 30, 2023, the U.S. District Court for the Northern District of Texas issued a final judgment in Braidwood Management Inc. v. Becerra, invalidating a requirement in the Patient Protection and Affordable Care Act (ACA)...more
Federally Qualified Health Centers (FQHCs) are required to provide all required primary, preventive, and enabling health services as well as additional health services as appropriate and necessary – either directly or through...more
The Food and Drug Administration (FDA) has announced transition plans for Emergency Use Authorization (EUA)-authorized medical devices and devices marketed pursuant to COVID-19-related guidance documents. The Transition...more
On March 21, 2023, CMS published in the Federal Register the Information Collection Request (ICR) Form, as required by the Paperwork Reduction Act, for Negotiation Data Elements under Sections 11001 and 11002 of the Inflation...more
Last year, a federal court in California ruled against the U.S. Food and Drug Administration (FDA) in a matter where the government alleged that a stem cell clinic’s products should be regulated as new drugs. The decision...more
On December 29, 2022, the President signed into law the Prepare for and Respond to Existing Viruses, Emerging New Threats and Pandemics Act (PREVENT Pandemics Act) as part of the Consolidated Appropriations Act, 2023 (P.L....more
The legislation contains several reforms to FDA’s statutory authority and the regulatory framework that it administers. Key Points: ..Omnibus legislation appropriates new funds to FDA and reauthorizes certain FDA...more
Now that FDA’s grace period for regenerative medicines has ended, many manufacturers of human cell, tissue, or cellular- or tissue-based products (HCT/Ps) will be required to file a biologics license application (BLA) with...more
In an effort to push hospitals toward compliance with federal hospital price transparency laws, Gov. Jared Polis signed HB 22-1285, “Prohibit Collection Hospital Not Disclosing Prices,” into law on June 8, 2022. Specifically,...more
The COVID-19 pandemic brought multiple temporary changes for ERISA-governed group health and welfare plans. Certain coverage mandates apply for only the duration of the COVID-19 public health emergency (the Public Health...more
The US Department of Health and Human Services’ (HHS) declaration that COVID-19 remains a public health emergency (PHE) will continue through July 15, 2022, and is expected to be renewed again through October 13, 2022....more
On May 27, 2022, Senate Health, Education, Labor, and Pensions (“HELP”) Committee leaders introduced the Food and Drug Administration Safety and Landmark Advancements Act of 2022 (“FDASLA Act of 2022”), which, if passed,...more