News & Analysis as of

Department of Health and Human Services (HHS) Comment Period Healthcare

Quarles & Brady LLP

Manufacturer Rebate Models: The Next 340B Program Battleground

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The 340B Drug Pricing Program (“340B Program”) space continues to be a hive of activity. While 340B stakeholders continue to litigate ongoing manufacturer contract pharmacy restrictions, states legislatures are enacting...more

BakerHostetler

HHS Issues a Request for Information on Deregulation and Innovation: Considerations for Legal and Compliance Teams

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On May 14, 2025, the U.S. Department of Health and Human Services (HHS) issued its Request for Information (RFI) “Ensuring Lawful Regulation and Unleashing Innovation To Make American Healthy Again,” which HHS describes as...more

Vorys, Sater, Seymour and Pease LLP

Proposed Update to the HIPAA Security Rule

In early January, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published a Notice of Proposed Rulemaking. The Proposed Rule would modify the Security Standards for the Protection of...more

Ballard Spahr LLP

HHS Proposes Significant Updates to HIPAA Security Rule

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On January 6, 2025, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) published a Notice of Proposed Rulemaking (“NPRM”) to amend the Health Insurance Portability and Accountability Act...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

Sheppard Mullin Richter & Hampton LLP

Comment Period for the No Surprises Act Proposed Rule, “Federal Independent Dispute Resolution (IDR) Operations,” Will Reopen

On January 17, 2024, the Departments of Health and Human Services, Labor, and the Treasury (collectively, the “Departments”) and the Office of Personnel Management issued a notice that they will reopen the period for...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: January 2024

The Department of Commerce and the National Institute of Standards and Technology are requesting comments on a “draft guidance framework designed to help federal agencies evaluate when it may be appropriate to exercise...more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

McDermott+

McDermottPlus Check-Up: June 23, 2023

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Congress was in session for a final week of legislative business before the two-week Independence Day recess. The House brought a small-business-focused healthcare bill to the floor, approving it along party lines....more

Epstein Becker & Green

HHS Proposes Amendments to HIPAA that Protect Reproductive Health Care Information in Wake of Dobbs

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Introduction - Following the Supreme Court decision in Dobbs v. Jackson Women’s Health Organization overturning Roe v. Wade, the federal government, pursuant to President Biden’s Executive Order (the EO) took several steps...more

Akerman LLP - Health Law Rx

OCR’s Proposed Rule Finds Fertile Ground for Enhanced Reproductive Privacy Protection

The Department of Health and Human Services Office for Civil Rights (OCR) issued a proposed rule on April 17, 2023, to amend provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) to strengthen...more

Polsinelli

HIPAA Notice of Proposed Rulemaking on Reproductive Health Care Privacy

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On April 12, 2023, the Department of Health and Human Services (“HHS”), Office for Civil Rights (“OCR”) issued a Notice of Proposed Rulemaking (“Notice” or “NPRM”) to solicit comments on proposed modifications to the HIPAA...more

Robinson+Cole Health Law Diagnosis

HHS Seeks to Strengthen Protections of Confidential Reproductive Health Information with Proposed Changes to HIPAA

On April 12, 2023, the U.S. Department of Health & Human Services (HHS) released a Notice of Proposed Rulemaking (Proposed Rule) that seeks to enhance safeguards of reproductive health care information through changes to the...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

Davis Wright Tremaine LLP

Deadline Approaching for Comments on Proposed Changes to Substance Use Disorder Confidentiality Rule

The Department of Health and Human Services ("HHS") has proposed amendments to the Confidentiality of Substance Use Disorder Patient Records Rule, 42 C.F.R. part 2 (the "Part 2 Rule") with a comment deadline of January 31....more

Robinson+Cole Health Law Diagnosis

HHS Proposes Rule to Align Part 2 Records and HIPAA

On November 28, 2022, the Department of Health and Human Services (HHS) issued a proposed rule to modify the confidentiality protections of Substance Use Disorder (SUD) patient treatment records under 42 CFR Part 2 (Part 2)...more

Proskauer on Privacy

Department of Health and Human Services Issues Request for Information on Cybersecurity Standards

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The Department of Health and Human Services (“HHS”) has issued a formal request for information from the public about how regulated entities are implementing industry recognized security practices. The request for information...more

Katten Muchin Rosenman LLP

New Cybersecurity Guidance for the Health Care Industry (and Last Call for HIPAA Rule Comments)

We discuss below two important updates impacting health care industry clients...more

BakerHostetler

It’s About Time (But Not Quite Yet)

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The comment period for the Notice of Proposed Rule Making (NPRM) regarding proposed changes to the Human Subjects Protection “Common Rule” issued by 16 federal departments and agencies in September has been extended an...more

King & Spalding

Also In The News - Health Headlines - October 2015 #3

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CMS Announces Part D Enhanced Medication Therapy Management Model Demonstration – On September 28, 2015, CMS announced a Part D Enhanced Medication Therapy Management Model (Enhanced MTM Model) that is designed to assess...more

King & Spalding

Omnibus Proposed Guidance Released for 340B Drug Pricing Program

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Last week, the Health Resources and Services Administration (HRSA), part of HHS, released proposed new guidance for covered entities enrolled in the 340B Drug Pricing Program, as well as drug manufacturers required to make...more

McDermott Will & Emery

HHS Releases Long-Awaited 340B Proposed Guidance

In August 27, 2015, the U.S. Department of Health and Human Services (HHS) released the long-awaited and much-anticipated proposed 340B Drug Pricing Program (340B Program) Omnibus Guidance (Proposed Guidance). The Proposed...more

McDermott Will & Emery

CMS Proposes Value-Based Purchasing Model, Other Updates to the 2016 Home Health Prospective Payment System

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The U.S. Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) published its proposed update to the home health prospective payment system (HHPPS) for calendar year (CY) 2016 in the July...more

K&L Gates LLP

340B Update: HRSA Proposes Penalties for Drug Manufacturers that Overcharge Covered Entities

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On June 16, 2015, the U.S. Department of Health and Human Services (“HHS”) and the Health Resources and Services Administration (“HRSA”) released proposed rules on civil monetary penalties and drug ceiling prices under the...more

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