News & Analysis as of

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

Epstein Becker & Green

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

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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

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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

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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 & Emery

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

McDermott Will & Emery 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

New Proposed Rules to Combat Health Information Blocking

Troutman Pepper on

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

Manatt, Phelps & Phillips, LLP

HHS Proposes New Data Privacy Protections Related to Reproductive Health Care Services

The Big Picture - On April 12, 2023, the Department of Health and Human Services (HHS) released a notice of proposed rulemaking to address the privacy of protected health information (PHI) related to reproductive health...more

Holland & Knight LLP

HHS Proposes HIPAA Changes to Protect Reproductive Health Information

Holland & Knight LLP on

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 & Emery

California DxF Policies and Procedures Released for Public Comment

McDermott Will & Emery on

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

Bass, Berry & Sims PLC on

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

Hogan Lovells on

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

Holland & Knight LLP on

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

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

Troutman Pepper 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

Manatt, Phelps & Phillips, LLP

OIG Quietly Revises Bases for Rejecting Advisory Opinion Requests

Responding to industry stakeholder sentiment, the Office of Inspector General (OIG) for the U.S. Department of Health & Human Services (HHS) recently issued an unexpected final rule that, effective February 10, 2022, will...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

Bricker Graydon LLP

First rules implementing surprise medical billing law issued

Bricker Graydon LLP on

On July 1, 2021, the U.S. Departments of Labor, Treasury, and Health and Human Services (HHS) issued the first rules implementing the No Surprises Act, which prohibits health care providers from billing patients more than...more

Holland & Knight LLP

HHS Issues Interim Final Rule Implementing Certain Provisions of the No Surprises Act

Holland & Knight LLP on

The U.S. Departments of Health and Human Services (HHS), Labor and Treasury, along with the Office of Personnel Management, on July 1, 2021, issued a much-anticipated Interim Final Rule with Comment Period (IFC) –...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - May 2021 #2

Latham & Watkins LLP on

PhRMA Suit Challenges Co-Pay/Accumulator Portion of December 2020 Medicaid Rule - On May 21, 2021, Pharmaceutical Research and Manufacturers of America (PhRMA) filed suit in the US District Court for the District of...more

Husch Blackwell LLP

Health And Human Services Extends Comment Deadline For Proposed Rule On HIPAA Privacy To May 6, 2021

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You may recall on December 10, 2020 we wrote about the Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announcement of a proposed rule that would revise the Health Insurance Portability and...more

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