K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
A Notice published on July 14, 2025 identifies 12 new Federal public benefit programs (see list below) for which non-qualified aliens are not eligible. Although it was published by the U.S. Department of Health and Human...more
On April 9, 2025, OIG posted Advisory Opinion No. 25-02, a favorable advisory opinion allowing a community health center operating under Section 330 of the Public Health Service Act (the Requestor) to ask individuals, to whom...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
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
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 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
Family Health Centers of San Diego (Health Center) operates a federally qualified health center (FQHC) that has 49 locations throughout San Diego County, California, and provides a comprehensive range of primary and...more
Although the Biden-Harris Administration that assumed control of the Executive Branch on January 20, 2021 immediately ordered a regulatory freeze of new or pending rules while the new administration gets its bearings, several...more
In a recent letter to state governors, Acting Secretary of Health and Human Services Norris Cochran signaled the US Department of Health and Human Services’ (HHS’s) commitment to “predictability and stability” in the ongoing...more
The protections for participants and their beneficiaries in the Patient Protection and Affordable Care Act (ACA) were expanded by the Consolidated Appropriations Act, 2021 (the “Act”). Some of the changes build on concepts in...more
On September 23, 2020, the US Food and Drug Administration (FDA) published its Regulations Regarding “Intended Uses” proposed rule (Proposed Rule) to amend its “intended use” regulations at 21 C.F.R. §§ 201.128 and 801.4. The...more
On July 20, 2020, the United States Food and Drug Administration (FDA) announced a six-month extension of its enforcement discretion policy for certain regenerative medicine products requiring pre-market review due to the...more
Businesses await clarity from the federal government on liability protections for injuries resulting from COVID-19. Current federal law provides liability protection to businesses but is limited to COVID-19 related...more
The move by some employer plans to a “reference-based” pricing model has created a need for healthcare providers to develop a strategy to confront payment challenges that these plans create. A prevalent model of...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 May 2, 2019 the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a controversial final rule, referred to as the “Conscience Rule.” If implemented, this rule would expand OCR’s...more
I. REGULATIONS, NOTICES, & GUIDANCE - On March 8, 2016, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule entitled, “Medicare Program; Part B Drug Payment Model.” The proposed rule seeks...more