News & Analysis as of

Department of Health and Human Services (HHS) Comment Period Health Care Providers

Husch Blackwell LLP

HHS Unveils 340B Drug Rebate Pilot Program

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On July 31, 2025, the U.S. Department of Health and Human Services (HHS) announced that it will conduct a pilot program testing out a rebate model for 340B drug purchases. Under the program, drug manufacturers will be allowed...more

Shipman & Goodwin LLP

340B Drug Pricing Program Is on a Slippery Slope

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On July 31, 2025, notice was published in the Federal Register by the Health Resources and Services Administration (“HRSA”) of a “340B Rebate Model Pilot Program” (“340B Pilot Program”). The 340B Pilot Program’s stated...more

Foley & Lardner LLP

HHS Guidance Excluding Non-Qualified Aliens from More Federal Programs Raises Questions for Providers and Grantees

Foley & Lardner LLP on

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

Foley & Lardner LLP

DEA Buprenorphine Rule Delayed to December 31, 2025

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The U.S. Department of Health and Human Services (HHS) and the Drug Enforcement Administration (DEA) have postponed the effective date of the final rule regarding telemedicine prescribing of buprenorphine (the final...more

Fisher Phillips

Proposed Updates to HIPAA Security Rule Would Require Entities to Adopt Enhanced Cybersecurity Measures

Fisher Phillips on

The HIPAA Security Rule may soon undergo a big overhaul that would better defend healthcare data from cybersecurity threats – and require much more from covered entities when it comes to establishing and maintaining defenses....more

Holland & Knight LLP

Big Changes Proposed for the HIPAA Security Rule

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The U.S. Department of Health and Human Services (HHS) has issued an unpublished Notice of Proposed Rulemaking (NPRM) that strengthens the Health Insurance Portability and Accountability Act (HIPAA) Security Rule and, if...more

Epstein Becker & Green

Last Call for Comments on Bipartisan Discussion Draft SUSTAIN Act: Shaping 340B for the Future

Epstein Becker & Green on

Only a few days remain for stakeholders—which includes drug manufacturers, patients, health care providers, pharmacies and others— to take advantage of a rare opportunity to influence the statutory contours of the 340B Drug...more

Mayer Brown

Private Equity in Healthcare: Increased Scrutiny from FTC, DOJ, and HHS

Mayer Brown on

Private equity acquisitions in healthcare will likely face increased scrutiny from multiple federal departments, as well as from state antitrust enforcement officials....more

Williams Mullen

42 CFR Part 2 Final Rule Harmonizes Substance Use Disorder Confidentiality Protections with HIPAA

Williams Mullen on

On February 8, 2024, the federal Confidentiality of Substance Use Disorder (SUD) Patient Records regulations at 42 CFR Part 2 (Part 2) were revised in part to increase patient protection and streamline patient consent...more

Holland & Knight LLP

Holland & Knight Health Dose: February 6, 2024

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

McDermott Will & Schulte

Stark Law Changes for 2024: CMS Updates Designated Health Services Code List

McDermott Will & Schulte on

On November 29, 2023, the Centers for Medicare & Medicaid Services (CMS) published the 2024 annual update to the designated health services (DHS) Code List. This annual update includes important changes for Medicare providers...more

Troutman Pepper Locke

New Proposed Rules to Combat Health Information Blocking

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The U.S. Department of Health and Human Services (HHS) has just unveiled a proposed rule designed to penalize health care providers engaging in information blocking. Information blocking is a practice where health care...more

Nelson Mullins Riley & Scarborough LLP

The Drive for Equitable Healthcare Access: Departments Seek Public Input on Over-the-Counter Preventive Services

On September 29, the Centers for Medicare & Medicaid Services (CMS) reported that the federal Departments of Health and Human Services, Labor, and the Treasury departments are seeking public input on the possibility of...more

Sheppard Mullin Richter & Hampton LLP

CFPB, other Federal Agencies Seek Public Comment about Medical Debt

On July 7, the CFPB, HHS, and Treasury announced a joint inquiry into high-cost specialty financial products which are being offered to patients as alternate forms of payment for routine medical care. Traditionally, these...more

Goodwin

DEA Publishes Temporary Rule on the Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Substances

Goodwin on

Since the declaration of the public health emergency due to the COVID-19 epidemic, Drug Enforcement Administration (DEA) registered practitioners have been able to prescribe controlled substances, without a prior in-person...more

Bass, Berry & Sims PLC

Proposed Changes to HIPAA Privacy Rule Strengthening PHI Protections for Reproductive Health Care Information Have Broad...

Bass, Berry & Sims PLC on

On April 13, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) released a Notice of Proposed Rulemaking (NPRM) to amend the HIPAA Privacy Rule, 45 C.F.R. Part 160 and Part 164, Subparts A...more

Holland & Knight LLP

HHS Proposes HIPAA Changes to Protect Reproductive Health Information

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The U.S. Department of Health and Human Services' (HHS) Office for Civil Rights (OCR) published a Notice of Proposed Rule Making (Proposed Rule) on April 12, 2023, proposing amendments to the Health Insurance Portability and...more

McDermott Will & Schulte

California DxF Policies and Procedures Released for Public Comment

On January 17, 2023, the California Health and Human Services Agency (CalHHS) released updated drafts of four policies and procedures (P&Ps) under the California Data Exchange Framework (DxF) to support the implementation of...more

Nelson Mullins Riley & Scarborough LLP

Proposed Changes to Confidentiality of Substance Use Disorder Patient Records Rules Would Support Better Care, Decrease Stigma,...

Amid the ongoing proliferation of headlines about the mental health crisis in the United States, of which substance use disorder is a large part, the recent issuance by the U.S. Department of Health and Human Services (HHS)...more

Bass, Berry & Sims PLC

CMS Proposed Rule Addresses Multiple Aspects of Medicare Advantage Program for 2024, Including an Overpayment Rule Update

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On December 14, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule that contemplates several changes to, and clarifications of, guidance for the Medicare Advantage (MA) program in coverage year 2024....more

Hogan Lovells

HHS proposes significant changes to Part 2 substance use disorder records regulations

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The U.S. Department of Health and Human Services (HHS) has proposed to significantly revise rules governing patient records in substance use disorder (SUD) programs, commonly known as the Part 2 rules, with important...more

Holland & Knight LLP

Highly Anticipated Third Interim Final Rule on Surprise Billing Released

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The U.S. Departments of Health and Human Services (HHS), Labor and the Treasury (the Departments) have issued a highly anticipated third interim final rule (IFR) implementing the No Surprises Act (NSA). The rule, issued on...more

Troutman Pepper Locke

HHS/OCR Seeks Comment on Scope and Implementation of “Recognized Security Practices”

Troutman Pepper Locke on

On April 6, the U.S. Department of Health and Human Services, Office of Civil Rights (HHS) called for public comment on an existing statutory provision that provides a safe harbor for entities that have voluntarily...more

Maynard Nexsen

New IDR Rules Under The No Surprises Act

Maynard Nexsen on

On September 30, 2021, the Department of Health and Human Services, the Department of Labor, and the Department of the Treasury (collectively, the “Departments”) released an interim final rule with comment period entitled...more

Bass, Berry & Sims PLC

First Installment of Surprise Billing Regulations Released

On July 1, the Department of Health and Human Services (HHS), Department of Labor, and Department of the Treasury (Departments) jointly issued interim final rules (IFR) implementing certain aspects of the No Surprises Act...more

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