News & Analysis as of

Centers for Medicare & Medicaid Services (CMS)

McDermott+

Healthcare Preview for the Week of: September 23, 2024

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One More Week Until Election Recess - The House and Senate are in Washington, DC, for one more week before leaving until after election day. Over the weekend, congressional leaders struck a deal on a continuing resolution...more

Holland & Knight LLP

CMS Releases Final Rule on the Medicaid Drug Rebate Program

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The Centers for Medicare & Medicaid Services (CMS) on Sept. 20, 2024, released the Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program (CMS-2434) Final Rule....more

Benesch

Dialysis & Nephrology Digest - September 2024

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Appellate court ruling widens scope of NY fee-splitting law to include earnouts - The decision overturned a lower court ruling relating to the sale of part of a dental practice in 2015. The plaintiff agreed to sell...more

Klein Moynihan Turco LLP

Medicare One-to-One Consent Rules Go Into Effect October 1!

Readers of this blog are aware of the fact that, beginning on October 1, 2024, the Medicare one-to-one consent rules will go into effect – requiring Third Party Marketing Organizations (“TPMOs”) who engage in Medicare-related...more

Fox Rothschild LLP

CMS Proposed Rule Decreases Physician Payments, Expands Telehealth, and Much More

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The comment period for the CMS CY 2025 Physician Fee Schedule (PFS) Proposed Rule recently closed on Monday, September 9th. Based on previous years, the Final Rule can be expected as soon as early November, taking effect...more

King & Spalding

CMS Issues Revised Guidance Regarding Enrollment and Conversion Process for Rural Emergency Hospitals

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On September 6, 2024, CMS released revised guidance regarding the process by which rural hospitals and outpatient facilities can participate in Medicare as a Rural Emergency Hospital (REH) rather than a Critical Access...more

Hogan Lovells

CMS issues Final Rule adopting some but not all proposed changes to the Medicaid Drug Rebate Program

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On September 20, 2024, the Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled: Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program....more

Miles & Stockbridge P.C.

Are You Part of the TEAM? CMS Prepares for New, Mandatory Payment Model

The CMS Innovation Center (CMMI) continues to prepare for its next episode-based alternative payment model, the Transforming Episode Accountability Model, or TEAM for short. This five-year model will offer both incentive...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

Beltway Buzz - September 2024 #3

The Beltway Buzz is a weekly update summarizing labor and employment news from inside the Beltway and clarifying how what’s happening in Washington, D.C., could impact your business....more

Morgan Lewis - ML Benefits

CMS Disclosures Due October 15: Is Your Plan’s Rx Coverage Still Creditable?

The Inflation Reduction Act (IRA) made several changes to Medicare Part D that may impact whether employer-sponsored coverage will be creditable for the 2025 plan year. With open enrollment season about to begin, plan...more

McDermott+

McDermott+ Check-Up: September 20, 2024

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Senate Judiciary Human Rights and the Law Subcommittee Holds Hearing on Georgia Abortion Ban. The field hearing examined how Georgia’s abortion ban impacts women’s health, and featured patient and physician witnesses. ...more

Benesch

CMS Announces a Second Preview Period for the October 2024 SNF Preview Reports

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On September 19, 2024, CMS announced a second preview period for the October 2024 SNF Preview Reports (“Preview Reports”) following the identification of a technical glitch that prevented the posting of these reports for...more

Alston & Bird

Health Care Week in Review: House Energy & Commerce Committee Held a Markup of 16 Bills; HRSA Demands Johnson & Johnson Cease 340B...

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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

Burr & Forman

Federal Agency Deference Eliminated, Now What?

Burr & Forman on

On June 28, 2024, the U.S. Supreme Court issued a decision that overrules the “Chevron doctrine.”  This means that federal agencies are limited in their ability to rely on their own interpretation of the laws they...more

McDermott+

Responses to the PFS Proposed Reg Are In: 10 Major Comments

McDermott+ on

McDermott+ is pleased to bring you Regs & Eggs, a weekly Regulatory Affairs blog by Jeffrey Davis. Click here to subscribe to future blog posts. September 19, 2024 – Comments on the calendar year (CY) 2025 physician fee...more

Bass, Berry & Sims PLC

More Losses than Gains? OIG Declines to Approve Certain Medicare Advantage Gainsharing Arrangements in Advisory Opinion 24-08

Bass, Berry & Sims PLC on

On September 13, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 24-08, in which it declined to approve a proposal by a Medicare Advantage organization (MAO)...more

Spilman Thomas & Battle, PLLC

The Health Record - Healthcare Law Insights, Issue 5, September 2024

Welcome to our fourth issue of The Health Record - our healthcare law insights e-newsletter. In this edition, we take a look at the Biden administration's proposed insurance rule regarding mental health and substance use...more

Health Care Compliance Association (HCCA)

The CMS Interoperability and Prior Authorization Rules

Healthcare lives on data. Getting it to the patient and providers is essential for delivering quality care, but that can be a challenge. As Eden Avraham-Katz, Vice President, Legal and Compliance at 1upHealth explains in...more

Foley & Lardner LLP

Medicare Advantage: A Circuit Court Addresses What is (or is not) Material in False Claims Act Cases

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Friday the 13th is not all bad luck. On September 13, 2024, the United States Court of Appeals for the Eighth Circuit’s published its much-anticipated decision in United States ex rel. Holt v. Medicare Medicaid Advisors,...more

Foley & Lardner LLP

The 340B Drug Pricing Program: Top Five Things to Know

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The 340B Drug Pricing Program continues to provide critical support for covered entities, although the program is subject to ongoing scrutiny and congressional, judicial, and industry pressures. Certain key guidance documents...more

Proskauer - Labor Relations Update

United States Government Accountability Office Finds Federal Contracting Rules do not Prohibit Labor Harmony Agreement...

In a decision issued on September 16, 2024, the United States Government Accountability Office (“GAO”) ruled that federal contracting rules do not prohibit government agencies from requiring contractors to enter into labor...more

Morgan Lewis

CMS Defers Low Wage Index Hospital Policy Changes in FY 2025 IPPS Final Rule Despite DC Circuit Holding

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The Centers for Medicare and Medicaid Services (CMS) has deferred taking immediate action on its low wage index hospital policy in light of the US Court of Appeals for the DC Circuit’s decision in Bridgeport Hospital v....more

Holland & Knight LLP

FDA Warning Letter Marks Significant Shift in Enforcement of Laboratory Developed Tests

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The U.S. Food and Drug Administration's (FDA) March 21, 2024, warning letter to Agena Bioscience Inc. (Agena), a genetic diagnostic test developer, generated a lot of immediate commentary among regulatory lawyers and...more

McDermott+

McDermott+ Check-Up: September 13, 2024

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House Education & the Workforce Health, Employment, Labor, and Pensions Subcommittee Holds Hearing on ERISA’s 50th Anniversary. Members and witnesses assessed how the Employee Retirement Income Security Act of 1974 (ERISA)...more

Manatt, Phelps & Phillips, LLP

CMMI Transforming Maternal Health (TMaH) Model Applications Due Soon

On June 26, the Centers for Medicare & Medicaid Services (CMS) released the Notice of Funding Opportunity (NOFO) for the Transforming Maternal Health (TMaH) Model. TMaH is ten-year delivery and payment model designed to test...more

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