News & Analysis as of

Public Health Service Act

Manatt, Phelps & Phillips, LLP

Johnson & Johnson Announces Rebate Model for Certain 340B Drugs; HRSA Pushes Back

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

Baker Donelson

60 Days After Loper: Health Care Impact of Chevron Deference's End

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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

MoFo Life Sciences

Senate Unanimously Passes Bill To Limit Patent Infringement Challenges By Drug Manufacturers

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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

McDonnell Boehnen Hulbert & Berghoff LLP

Senators Get Their Colleagues to Agree on Drug Patent Litigation Legislation

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

McDonnell Boehnen Hulbert & Berghoff LLP

Senators Get Their Colleagues to Agree on Drug Patent Litigation Legislation

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

Venable LLP

Implications of Loper Bright for FDA-Regulated Products

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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

Wiley Rein LLP

Manufacturers Are “Winning” in the 340B Drug Discount Dispute

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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

Mandelbaum Barrett PC

The No Surprises Act: A Look at What Dentists Need to Know

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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

Stevens & Lee

Gag Clause Prohibitions in ERISA, the Internal Revenue Code and the Public Health Service Act

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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

Jones Day

Congress Authorizes Competitive Multivendor Contracts in U.S. Organ Transplant System

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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

Davis Wright Tremaine LLP

New FAQs Address No Surprises Act Impact on ACA Maximum Out-of-Pocket Limits and Facility Fee Transparency

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

Holland & Knight LLP

CMS Proposes Returning $9 Billion to More Than 1,600 Hospitals

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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

McDermott Will & Emery

OIG Final Rule Expands OIG Enforcement Authority to Grant and Contract Fraud

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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

Epstein Becker & Green

Federal Judge in Texas Strikes Down ACA’s Preventive Services Coverage Mandate

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

Hinshaw & Culbertson - Health Care

Federally Qualified Health Center Provider Referral Contracts and Arrangements

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

Foley Hoag LLP

The FDA Finalizes Transition Plan for Medical Device Authorizations and Policies Affected by Covid-19 PHE

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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

Foley Hoag LLP

Information Collection Request for Drug Price Negotiation Program Data Elements

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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

Hogan Lovells

O.K. Corral: FDA sets stage to appeal California Stem Cell Treatment Center decision

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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

Akin Gump Strauss Hauer & Feld LLP

Preparedness Policy Takes Shape: PREVENT Pandemics Act Enacted Ahead of PAHPA Reauthorization

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

Latham & Watkins LLP

Food and Drug Omnibus Reform Act Introduces Key Changes to FDA’s Authorities

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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

Hogan Lovells

Six strategies for clinical trial & marketing application success as FDA requires HCT/P BLAs

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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

Brownstein Hyatt Farber Schreck

Colorado Raises Stakes for Hospitals That Don’t Comply With Price Transparency Law

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

Morgan Lewis

Preparing for the End of COVID-19 Emergency Periods: To-Dos for Plan Sponsors and Administrators

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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

ArentFox Schiff

HHS COVID-19 Public Health Emergency Persists as California COVID-19 Policies Are Set To Expire

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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

King & Spalding

Act II: The Senate Unveils Its Draft

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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

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