News & Analysis as of

Reporting Requirements Department of Health and Human Services (HHS)

Wilson Sonsini Goodrich & Rosati

HHS Announces Increased Resources to Enforce Information Blocking Prohibition

On September 3, 2025, the U.S. Department of Health and Human Services (HHS) announced that HHS would increase resources to enforce the information blocking prohibition under the 21st Century Cures Act. Generally, the...more

King & Spalding

CMS Issues Final Rule for Updates to Medicare Payment Rates for Skilled Nursing Facilities Under the Skilled Nursing Facility...

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On August 4, 2025, CMS issued a final rule (Final Rule) updating payment rates, policies, and quality programs for Skilled Nursing Facilities (SNFs) under the Medicare Prospective Payment System (SNF PPS) for Fiscal Year (FY)...more

King & Spalding

OIG Issues Series of Reports on Patient Harm in Hospitals and Gaps in Reporting

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On July 24, 2025, the OIG released reports evaluating the prevalence of patient harm in hospitals and the extent to which hospitals detect and report such events. These evaluations follow up on OIG’s 2022 report and provide...more

Perkins Coie

Caffeine Safety Legislation Introduced in Congress

Perkins Coie on

On March 31, 2025, Congress saw the reintroduction of H.R. 2511, the Sarah Katz Caffeine Safety Act. The bill would amend the Federal Food, Drug, and Cosmetic Act to establish new regulatory requirements for labeling the...more

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

Alston & Bird

Health Care Week in Review | CMS Finalizes FY 2026 Medicare Payment Rules, Senate Appropriations Committee Advances Labor-HHS...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Dinsmore & Shohl LLP

HRSA Announces Pilot Program for 340B Rebate Models

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On the heels of multiple lawsuits disrupting drug manufacturers’ efforts to convert the 340B Program into a rebate-based model, the Health Resources and Services Administration (HRSA) released a Notice[1] announcing the...more

Robinson+Cole Health Law Diagnosis

HHS Publishes 340B Guidance Proposing Rebate Pilot Program

On July 31, 2025, the Department of Health and Human Services (HHS) announced a much-anticipated 340B Rebate Model Pilot Program (Pilot Program) via guidance (Guidance) that will be formally published on August 1, 2025. The...more

Morrison & Foerster LLP

True Facts About False Claims: MoFo's FCA Newsletter - July 2025

Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter,...more

Epstein Becker & Green

Latest Moves by Federal Agencies Regarding Gender-Affirming Care: Risks Mount for Providers

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Since day one, a policy priority of the Administration has been to discourage and prevent gender-affirming care for children and adolescents that involves surgery or medication....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

King & Spalding

OIG Audit of Provider Relief Fund Payments to Hospitals Finds Substantial Noncompliance with Federal Requirements

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On June 13, 2025, OIG announced the results of an audit it conducted of 30 hospitals that received provider relief fund (PRF) payments during COVID-19 (the Audit). OIG found that 11 of the 30 audited hospitals failed to...more

Morrison & Foerster LLP

New Dietary Ingredient Notifications: FDA Addresses Common Pitfalls and Shares New Educational Tools

On June 11, 2025, the U.S. Food and Drug Administration (FDA) released educational videos and a new fact sheet to facilitate compliance with the agency’s New Dietary Ingredient Notification (NDIN) review process. Under the...more

McDermott+

CMS Requests Hospitals Submit Gender-Affirming Care Data- (UPDATED)

McDermott+ on

On May 28, 2025, the Centers for Medicare & Medicaid Services (CMS) sent a letter to “select hospitals” that provide gender-affirming care services, requesting information about how those hospitals adhere to quality standards...more

McDermott Will & Schulte

CMS Requests Hospitals Submit Gender-Affirming Care Data

On May 28, 2025, the Centers for Medicare & Medicaid Services (CMS) sent a letter to “select hospitals” that provide gender-affirming care services, requesting information about how those hospitals adhere to quality standards...more

Lathrop GPM

Administration Issues Cross-Agency Guidance Targeting Health Care Pricing and Focusing on Hospitals and Health Plans

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On May 22, 2025, the U.S. Department of Health and Human Services, Department of Treasury and Department of Labor (the “Agencies”) announced new steps intended to “strengthen healthcare price transparency.” ...more

Epstein Becker & Green

The Final Rule on Research Misconduct Regulations: What Institutions Need to Know as Implementation Looms

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When the current federal administration took office, it issued a memorandum requiring, among other things, that federal agencies delay the issuance of new or proposed rules to the Office of the Federal Register until further...more

Holland & Knight LLP

New York Budget Omits Changes to State's "Disclosure of Material Transactions" Law

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In a prior blog post, we summarized proposed legislation included in New York Gov. Kathy Hochul's state fiscal year (FY) 2025-2026 budget that would have subjected "material transactions" to additional disclosure and...more

Akin Gump Strauss Hauer & Feld LLP

Improving the Safety and Security of Biological Research (Trump EO Tracker)

This Executive Order establishes a policy of the United States to ensure that federally funded research benefits American citizens without jeopardizing national security, strength or prosperity. The order seeks to strengthen...more

Rivkin Radler LLP

OIG Audit of MACs Finds Deficiencies

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The 12 regional Medicare Administrative Contractors (MACs) were recently audited by the U.S. Department of Health and Human Services’ Office of Inspector General (OIG). Each of the MAC jurisdictions was found by the OIG to...more

Sheppard Mullin Richter & Hampton LLP

New York State Releases Much Anticipated Guidance on Reporting Requirements for Material Healthcare Transactions as Budget...

On August 1, 2023, the New York State’s Department of Health (the “DOH”) began implementation of Public Health Law Article 45-A, the State’s new statutory requirement for advance notice and public disclosure of certain...more

Nelson Mullins Riley & Scarborough LLP

Senate Bill 316: An Overview for North Carolina Hospitals

Earlier this week, Senate Bill 316 (the “Bill”) was filed in the North Carolina state legislature. The Bill covers a large swathe of healthcare-related issues, and the additional regulatory elements of the Bill would likely...more

Foley & Lardner LLP

Colorado: Proposed Expanded Medical Care Transaction Oversight - What Providers and Investors Need to Know

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On March 5, 2025, two Senators and one Representative introduced SB 25-198 (the Bill), designed to enhance transparency in transactions involving health care entities. The Bill seeks to impose notification and reporting...more

BakerHostetler

Trump Signs Price Transparency Executive Order

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On Tuesday, Feb. 25, President Donald Trump signed an executive order titled “Making America Healthy Again by Empowering Patients with Clear, Accurate, and Actionable Healthcare Pricing Information” (the Executive Order)....more

Epstein Becker & Green

A Regulatory Haze of Uncertainty Continues as the Clock Ticks Toward Phase One of FDA’s LDT Final Rule

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Clinical laboratories still face uncertainty and the difficult decision of whether to start the work needed to comply with the with Phase 1 expectations under FDA’s Laboratory Developed Tests Final Rule (the “LDT Final...more

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