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
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
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
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
As of January 1, 2022, certain provisions of the “Consolidated Appropriations Act,” commonly referred to as the “No Surprises Act” (Act), are in effect. The Act amends the Public Health Service Act, Employee Retirement Income...more
On November 15, 2019, the Centers for Medicare & Medicaid Services (CMS) finalized a rule requiring hospitals to make public a list of standard charges for items and services provided by such hospitals (the Rule). (The...more
On June 13, the Departments of Labor, Treasury and Health and Human Services jointly released final regulations dealing with health reimbursement accounts (“HRAs”). These regulations fulfill the Trump administration’s...more
On June 13, 2019, the Department of Health and Human Services (HHS), the Department of Labor (DOL), the Department of the Treasury (Treasury Department) and the Internal Revenue Service (IRS) (collectively, the “Departments”)...more
Court says Congress has the power to make the change that HHS attempted with its Interpretive Rule, and thus it should be left to the legislative branch. A lawsuit challenging the Interpretive Rule, filed by the...more
The Biologics Price Competition and Innovation Act of 2009 (BPCIA) created an abbreviated pathway for the approval of biosimilar biological products, but is silent on how to name them. The nonproprietary naming of...more
This Week: CMS Releases Guidance on Fast Track Process for 1115 Waivers for Medicaid and CHIP... Healthcare.gov CEO Sends Letter to State Insurance Commissioners Concerning 2016 Premium Decisions... Medicare Board of Trustees...more
Biologics are large molecules made from, derived from, or extracted from a natural source such as a human, animal, or microorganism that are used in the treatment, diagnosis, or prevention of disease. Biologics include...more
On July 21, 2014, the Health Resources and Services Administration of HHS (HRSA) issued an interpretive rule interpreting Section 340B(e) of the Public Health Service Act as excluding from the 340B Drug Pricing Program orphan...more
Commencing with plan and policy years beginning on or after January 1, 2014, the Affordable Care Act amends the Public Health Service Act (“PHS Act”) to make three important changes to the rules governing health insurance...more
Rule requires most manufacturers to change government pricing methodologies, calculations, and systems. On July 23, the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human...more
A May 10 Wall Street Journal article, “Employers Eye Bare-Bones Health Plans Under New Law” (see the associated video on WSJ Live), highlighted a compliance strategy to minimize employer exposure for assessable payments under...more