News & Analysis as of

Final Rules Regulatory Requirements Health Care Providers

Benesch

CMS Terminates KCF Model and Finalizes Significant Revisions to CKCC Participation and Payment Framework

Benesch on

On May 28, 2025, the Centers for Medicare & Medicaid Services (“CMS”) Innovation Center formally announced the early termination of the Kidney Care First (“KCF”) model effective December 31, 2025, and issued a suite of...more

McDermott Will & Emery

Trending in Telehealth: April 2025

McDermott Will & Emery on

Trending in Telehealth highlights monthly state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and...more

Schwabe, Williamson & Wyatt PC

Regulatory Changes Address Surge of Food-As-Health Initiatives and Shift “Healthy” ‎Standard; Plus New Labeling Requirements

Food and beverage products that promote health and well-being have proliferated. Demand has surged for foods and drinks that are loaded with nutrients and offer health benefits. Their growth is partly driven by an increased...more

Holland & Knight LLP

CMS Final Rule on CY 2026: Policy and Technical Changes

Holland & Knight LLP on

The Centers for Medicare & Medicaid Services (CMS) released on April 4, 2025, the final rule for contract year (CY) 2026 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit...more

Foley & Lardner LLP

DEA Buprenorphine Rule Delayed to December 31, 2025

Foley & Lardner LLP on

The U.S. Department of Health and Human Services (HHS) and the Drug Enforcement Administration (DEA) have postponed the effective date of the final rule regarding telemedicine prescribing of buprenorphine (the final...more

McDermott+

Breaking Down the New No Surprises Act FAQs Post-TMA III

McDermott+ on

On January 14, 2025, the US Departments of Labor, Health and Human Services (HHS), and the Treasury (collectively, the Departments), along with the Office of Personnel Management (OPM), jointly issued Part 69 of a series of...more

Baker Donelson

CMS Enacts New CLIA Regulations Effective January 2025

Baker Donelson on

On December 23, 2023, CMS issued its Final Rule, establishing new Clinical Laboratory Improvement Amendments (CLIA) regulations (the Final Rule). Several provisions only became effective December 28, 2024. CMS was driven to...more

McDermott Will & Emery

FDA Relaxes Critical Positions on Use of Scientific Information in Off-Label Communications

McDermott Will & Emery on

On January 6, 2025, the US Food and Drug Administration (FDA) published final guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical...more

Stotler Hayes Group, LLC

Medicare Advantage Plans Onerous Prior Authorizations Requirements & Negative Impacts on Skilled Nursing Facilities

Traditional Medicare (Parts A and B) and Medicare Advantage (Part C, including additional vision, dental, and hearing benefits) plans aim to provide comprehensive medical benefits to American Seniors and adults with...more

Foley Hoag LLP

FDA Finalizes Guidance on Scientific Information on Unapproved Uses (SIUU) Communications

Foley Hoag LLP on

On January 6, 2025, FDA published a final version of its guidance document, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products.” This...more

McCarter & English, LLP

New Jersey Regulatory Update Part II - February 2025

We continue our New Jersey Regulatory Update with this Part II, which focuses on regulations that were finalized in the second half of 2024 and impact healthcare. For example, as a continuation of price transparency efforts,...more

McDermott Will & Emery

CMS Implements First Major Updates to Lab Personnel Requirements in 30+ Years

On December 28, 2024, a long-awaited Centers for Medicare & Medicaid Services (CMS) final rule became effective, significantly updating laboratory personnel requirements under Subpart M of the Clinical Laboratory Improvement...more

Holland & Knight LLP

Holland & Knight Health Dose: January 29, 2025

Holland & Knight LLP on

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

McCarter & English, LLP

New Jersey Regulatory Update Part I - January 2025

Below is Part I of our New Jersey Regulatory Update focusing on regulations that were finalized in 2024 by various New Jersey agencies that impact healthcare. The final regulations range from additional transparency...more

Womble Bond Dickinson

FDA Broadens Oversight of Lab-Developed Tests

Womble Bond Dickinson on

Lab-developed tests (LDTs) are laboratory tests where blood is drawn and placed in a test tube to help with identification, diagnosis, and treatment of diseases, conditions, and infections. Examples of LDTs are the COVID-19...more

Baker Donelson

OCR Issues "Dear Colleagues" Letter Regarding AI in Medicine

Baker Donelson on

On May 6, 2024, OCR published the final rule interpreting and implementing Section 1557 at 45 C.F.R. § 92 (the Final Rule). The Final Rule regulates the use of patient care decision support tools, including AI algorithms for...more

Hendershot Cowart P.C.

Major Changes to Texas Medical Board Rules: What Healthcare Providers Need to Know

Hendershot Cowart P.C. on

On January 9, 2025, the Texas Medical Board (TMB) implemented comprehensive changes to its rules, marking a significant shift in how medical spas, IV hydration clinics, and other healthcare facilities operate in Texas....more

Epstein Becker & Green

At Long Last, DEA’s Remote Prescribing Rules 2.0 Are (Really) Here! (Pending Further Consideration by the Incoming Administration...

Epstein Becker & Green on

Remote prescribing via telemedicine continues to be a huge area of interest among prescribers and other health care providers....more

Verrill

Prescription for Change: Massachusetts Pharmacies Undergo Regulatory Revamp

Verrill on

Pharmacies doing business in Massachusetts must act now – The Massachusetts Board of Registration in Pharmacy (the “Board”) has announced a series of new and long-awaited pharmacy licensure regulations that took effect in...more

Akin Gump Strauss Hauer & Feld LLP

FDA Finalizes Guidance on Communication of Unapproved Uses of Approved or Cleared Medical Products

On January 6, 2025, the FDA released final guidance for industry entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions...more

Baker Donelson

Upcoming Deadline to Apply for Medicare-Funded Residency Positions

Baker Donelson on

Teaching hospitals training over their graduate medical education (GME) caps have limited opportunities to receive additional funding from Medicare. ...more

Ropes & Gray LLP

FDA Finalizes Guidance on Communication of Scientific Information on Unapproved Uses and Releases Updated First Amendment Analysis

Ropes & Gray LLP on

On January 7, 2025, FDA published a final guidance entitled Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products - Questions and Answers...more

King & Spalding

FDA Finalizes Guidance on Scientific Information on Unapproved Uses (SIUU)

King & Spalding on

Final Guidance Further Expands Scope of Permissible Proactive Off-Label Communications - On January 6, 2025, FDA finalized its guidance entitled Communications From Firms to Health Care Providers Regarding Scientific...more

Burr & Forman

Failure to Return Credit Balances (Especially to Medicare and Medicaid) Can Create Significant Liability

Burr & Forman on

Every health care provider has “credit balances,” which occur when a provider receives more money than it is owed for services rendered. Credit balances can be caused by a number of factors, including incorrect coding,...more

McCarter & English, LLP

Nursing Home Update

The federal government has made a variety of changes to federal requirements aimed at improving the quality of care at long-term care facilities across the country. In May 2024, the United States Department of Health and...more

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