News & Analysis as of

Administrative Procedure Act Final Rules Department of Health and Human Services (HHS)

Hogan Lovells

HHS Secretary Directs FDA to Explore Rulemaking to Eliminate Self-GRAS Pathway

Hogan Lovells on

The Secretary of the U.S. Department of Health and Human Services (HHS), Robert F. Kennedy, Jr., recently issued a press release directing the Food and Drug Administration (FDA) to take steps to explore possible rulemaking to...more

Proskauer - Health Care Law Brief

HHS Scraps Richardson Waiver, Clearing Way for Faster Rulemaking

On March 3, 2025, the United States Department of Health and Human Services (“HHS”) issued a policy statement rescinding the Richardson Waiver, a policy in place since 1971 that required notice-and-comment rulemaking for...more

Akerman LLP - Health Law Rx

No (Public) Comment: HHS Rescinds Policy on Public Participation in Rulemaking

The Department of Health and Human Services (HHS) recently rescinded its policy dating back to 1971 to now allow its agencies and offices to quickly alter certain rules and regulations without public notice and comment. The...more

Foley Hoag LLP

Department of Health and Human Services Seeks to Revise Rulemaking Policies

Foley Hoag LLP on

On Friday, February 28, 2025, the Department of Health and Human Services (HHS) issued a policy statement announcing changes to rulemaking processes for agencies within HHS. According to the statement, HHS is rescinding a...more

ArentFox Schiff

HHS Rescinds Richardson Waiver and Signals Reduced Opportunity for Public Comment on Agency Action

ArentFox Schiff on

On March 3, the US Department of Health and Human Services (HHS) published a change in policy that could result in fewer opportunities for stakeholders and members of the public to weigh in on HHS regulatory action related to...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

Employer Group Sues to Block Mental Health Parity Rules

Only weeks after the principal effective date for the final 2024 federal mental health parity rules for employer-sponsored health benefit plans, those rules—and specifically some key features that are frustrating...more

Troutman Pepper Locke

Federal Appellate Court Agrees that FDA Cannot Regulate “Premium Cigars”

Troutman Pepper Locke on

Yet again, the premium cigar industry has prevailed in federal court against the U.S. Food and Drug Administration (FDA). FDA appealed a federal district court decision vacating its rule (the Deeming Rule) subjecting premium...more

Arnall Golden Gregory LLP

Lawsuit Challenges Hospice Special Focus Program Rule and List

A group of four state associations and a hospice provider have filed a federal lawsuit in Texas challenging the Special Focus Program (“SFP”) Final Rule and the resulting list of hospices identified as poor performers. The...more

ArentFox Schiff

HIPAA Reproductive Privacy Rule Takes Effect Amid Legal and Political Uncertainties

ArentFox Schiff on

As of December 23, health care providers, health plans, and health care clearinghouses (covered entities) and their business associates (collectively, regulated entities) must comply with new reproductive health care privacy...more

Mintz - Health Care Viewpoints

Texas Challenges HHS’s HIPAA Rule Protecting Reproductive Health Information from State Investigative Bodies

Last week, Texas Attorney General Ken Paxton filed a complaint in federal district court against HHS and the Office for Civil Rights (OCR) challenging a recently issued rule strengthening protection of protected health...more

Proskauer - Health Care Law Brief

Post‑Chevron Spotlight: Disproportionate Share Hospital Payments Restored as Texas Hospitals Prevail in Challenge to HHS Exclusion...

In a victory for Texas health care providers, in Baylor All Saints Medical Center dba Baylor Scott & White All Saints Medical Center‑Fort Worth et al. v. Xavier Becerra, case number 4:24‑cv‑00432, the United States District...more

Bass, Berry & Sims PLC

Chevron No More: The Impact on Benefit Plans

Bass, Berry & Sims PLC on

On June 28, 2024, the Supreme Court issued its opinion in Loper Bright Enterprises v. Raimondo, Secretary of Commerce and Relentless, Inc. v. Department of Commerce (Loper Bright), overturning Chevron U.S.A. Inc v. Natural...more

Bass, Berry & Sims PLC

Healthcare Private Equity: What to Expect for the Rest of 2024

Bass, Berry & Sims PLC on

Although the U.S. healthcare industry has weathered the storm over the past couple of years, we may be reaching calmer waters in the coming months. Dry powder held by U.S. private equity investors has reached an all-time...more

Foley Hoag LLP - Cannabis and the Law

The DEA’s Rule to Reschedule Cannabis to Schedule III: Process and Timeline

On April 30, 2024, the Associated Press (AP) reported the Drug Enforcement Administration (DEA) will propose a rule to reschedule cannabis from Schedule I to Schedule III under the Controlled Substances Act (CSA). More...more

McDermott Will & Emery

District Court Vacates Provisions of No Surprises Act Final Rule

McDermott Will & Emery on

On February 6, a US district court in Texas vacated provisions of the No Surprises Act final rule related to the independent dispute resolution (IDR) process for determining payment for out-of-network services....more

Foley Hoag LLP - Medicaid and the Law

The Avon Nursing Case: A Lesson in Challenging Medicaid Rulemaking for Providers

Medicaid providers seeking to directly challenge HHS rulemaking recently found success in the 2nd Circuit. In the recent case of Avon Nursing & Rehab v. Becerra, the court sided with a skilled nursing home provider bringing a...more

Sheppard Mullin Richter & Hampton LLP

Secret Rules and Hidden Penalties: Biden Executive Order Takes Aim at the Trump Administration’s Efforts to Limit HHS’s Use of...

Executive Orders and the Biden Administration’s promises to postpone or withdraw certain last-minute, so-called “midnight rules” promulgated by the Trump Administration are currently grabbing everyone’s attention, especially...more

McDermott Will & Emery

“Because of Bostock” – Court Delays HHS Rule Re-interpreting Section 1557 Discrimination “Because of Sex”

McDermott Will & Emery on

One day before an updated rule of the US Department of Health and Human Services regarding Section 1557 of the Patient Protection and Affordable Care Act took effect, the US District Court for the Eastern District of New York...more

ArentFox Schiff

No Drug List Prices on Direct-to-Consumer Ads

ArentFox Schiff on

On July 8, 2019, in Merck & Co., Inc. v. United States Department of Health and Human Services, the US District Court for the District of Columbia invalidated a final rule pursuant to which pharmaceutical manufacturers would...more

Jones Day

Legislation, Lawsuit Cloud Future of 340B Program Payment Rate Reductions

Jones Day on

The Situation: A Final Rule published by the Centers for Medicare & Medicaid Services carries a provision that reduces reimbursement for most 340B Program drugs dispensed by disproportionate share hospitals and rural referral...more

Foley & Lardner LLP

Court Strikes Down 340B Orphan Drug Rule Again: Will This Impact the “Mega Guidance”?

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A federal court vacated the Department of Health and Human Services’ (HHS) Orphan Drug Rule that had allowed certain 340B Drug Pricing Program (340B Program) hospital covered entities to receive discounted prices when...more

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