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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

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

McDermott Will & Emery

CMS Updates SNF Attachment Guidance Ahead of May 1 Enrollment Deadline

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Skilled nursing facilities (SNFs) historically have been required to disclose ownership and managerial control information as part of their Medicare enrollment. However, these requirements were significantly expanded to...more

Arnall Golden Gregory LLP

AGG Talks: Cross-Border Business Podcast - Episode 27: U.S. Healthcare Reimbursement Guidance for Foreign Life Sciences Companies

In this episode, Mike Burke, AGG Corporate partner and co-chair of the firm’s International practice, is joined by Andrew Tsui, AGG Healthcare Litigation partner, to explore the intricacies of reimbursement in the U.S....more

McCarter & English Blog: Government Contracts...

Antitrust Corporate Compliance Programs: Late 2024 Changes Mean Companies Should Revisit Their Programs Early in 2025

The US Department of Justice Antitrust Division (DOJ or Division) recently released a revised Evaluation of Corporate Compliance Programs in Criminal Antitrust Investigations (Guidance). The Guidance reflects how the Division...more

King & Spalding

OIG Issues Nursing Facility Compliance Guidance

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On November 20, 2024, OIG released new compliance program guidelines for nursing facilities titled, “Nursing Facility Industry Segment-Specific Compliance Program Guidance” (the Nursing Facility ICPG or the Guidance). The...more

McNees Wallace & Nurick LLC

The OIG Releases Updated General Compliance Program Guidance

As 2023 came to a close, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released an updated General Compliance Program Guidance (GCPG) manual, which serves as a reference guide for...more

Foley Hoag LLP

CMMI Announces Medicare Dementia Care Model

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The GUIDE Model is an eight-year model that will test an alternative payment for participants that delivers key supportive services to people with dementia, including comprehensive, person-centered assessments and care plans,...more

Robinson & Cole LLP

Health Law Diagnosis - CMS Issues Guidance for Providers on Waivers, Flexibilities and End of COVID-19 Public Health Emergency

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The Centers for Medicare & Medicaid Services (CMS) recently issued a Fact Sheet (Fact Sheet) providing guidance on the impact of the end of the federal COVID-19 Public Health Emergency (PHE) on certain regulatory waivers,...more

Robinson+Cole Health Law Diagnosis

CMS Issues Guidance for Providers on Waivers, Flexibilities and End of COVID-19 Public Health Emergency

The Centers for Medicare & Medicaid Services (CMS) recently issued a Fact Sheet (Fact Sheet) providing guidance on the impact of the end of the federal COVID-19 Public Health Emergency (PHE) on certain regulatory waivers,...more

Mintz - Health Care Viewpoints

CMS’s Advance Notice and Call Letter: How Medicare Plans Can Report, Identify, and Address the Opioid Epidemic

CMS has slowly but surely been providing additional guidance to Medicare Plans (Medicare Advantage and Part D plans) regarding steps they can and should take to address the opioid epidemic as it relates to their...more

Alston & Bird

Alston & Bird Healthcare Week in Review

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On November 15, 2017, the Food and Drug Administration (FDA) issued a draft guidance entitled, Assessing User Fees Under the Biosimilar User Fee Amendments of 2017. The Biosimilar User Fee Amendments of 2017 (BsUFA II)...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

Mintz - Health Care Viewpoints

CMS Takes Initial Steps to Address Medicare & Medicaid Coverage for Biosimilars

On March 30, 2015, CMS released guidance addressing Medicare and Medicaid coverage for biosimilar drug products. The Medicare/Medicaid coverage guidance comes on the heels of the FDA’s landmark approval of a biosimilar...more

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