News & Analysis as of

Final Rules Proposed Rules Pharmaceutical Industry

McDermott+

CY 2026 MA and Part D Final Reg: Policies Under Consideration

McDermott+ on

Last week, the contract year (CY) 2026 Medicare Advantage (MA) and Part D final reg entered the clearance process at the Office of Management and Budget (OMB). As mentioned in a previous Regs & Eggs blog post, OMB’s review is...more

Blake, Cassels & Graydon LLP

Santé Canada propose un règlement visant à atténuer les pénuries de drogues et d’instruments médicaux

Santé Canada a récemment publié un projet de règlement visant à pallier les pénuries de produits thérapeutiques au Canada. Le Règlement modifiant certains règlements pris en vertu de la Loi sur les aliments et drogues...more

Axinn, Veltrop & Harkrider LLP

Pounding the Compounders: FDA’s “No Compound” Lists

Novo Nordisk recently made headlines petitioning FDA to stop the compounding of its blockbuster GLP-1 products so it can sell its patented semaglutide drugs exclusively. Compounding is the practice of creating new drug...more

Rivkin Radler LLP

DEA Announces New Telemedicine Rules Expanding Access to Controlled Substances

Rivkin Radler LLP on

On January 16, the U.S. Drug Enforcement Administration (DEA) announced three new telemedicine rules that extend prescribing flexibilities for controlled substances, following the expiration of temporary flexibilities granted...more

McGuireWoods Consulting

Washington Healthcare Update - July 2024

This Week in Washington: House Ways and Means Committee marks up healthcare bills related to new technologies and coverage for weight loss drugs; CMS releases CY2025 Home Health and End-Stage Renal Disease PPS proposed rules;...more

Quarles & Brady LLP

FDA Publishes Final Rule on Regulation of Lab-Developed Tests

Quarles & Brady LLP on

On May 6, 2024 the FDA published its much-anticipated Final Rule on Lab-Developed Tests (“LDTs”) to make explicit that in vitro diagnostic products (“IVDs”) are devices under the Federal Food, Drug, and Cosmetic Act (“FD&C...more

McDermott+

It’s Raining Regs: CMS Releases Major Laboratory-Developed Test Reg in Midst of Massive Reg Storm

McDermott+ on

Over the last several weeks, the Biden administration has released numerous final regulations in order to “beat the clock” before it ticks down to the Congressional Review Act (CRA) deadline. The CRA authorizes Congress to...more

Bass, Berry & Sims PLC

The End of an Era? FDA Finalizes LDT Rule But Grandfathers Many Existing LDTs

On May 6, 2024, the Food and Drug Administration (FDA) published its final rule for laboratory developed tests (LDTs). The final rule cemented the agency’s forecasted decision to increase the FDA’s regulatory oversight of...more

McDermott Will & Emery

HHS Issues 340B Administrative Dispute Resolution Final Rule

McDermott Will & Emery on

On April 18, 2024, the US Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) issued the long-awaited 340B Administrative Dispute Resolution (ADR) Final Rule. The final rule...more

McGuireWoods Consulting

Washington Healthcare Update - February 2024 #2

This Week in Washington: Senate Finance Committee holds hearing on AI use in healthcare; CMS makes corrections to 2024 Hospital Outpatient Prospective Payment Rates; House passes ban on QALYs....more

McDermott Will & Emery

Trending in Telehealth: January 4 – 15, 2024

McDermott Will & Emery on

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

McGuireWoods Consulting

Washington Healthcare Update - December 2023

This Week in Washington: House Energy and Commerce subcommittees look at role of AI and CDC respiratory disease preparedness; FDA releases final rule on prescription drug advertisements....more

McGuireWoods Consulting

Washington Healthcare Update - November 2023 #3

McGuireWoods Consulting on

This Week in Washington: House and Senate pass continuing resolution; House Energy and Commerce Health Subcommittee reports out 21 healthcare bills; Senate Finance Healthcare Subcommittee holds hearing on telehealth...more

Quarles & Brady LLP

Mississippi Board of Pharmacy Approves Final Rule on Shared Pharmacy Services with Minor Modifications

Quarles & Brady LLP on

On September 21, 2023, the Mississippi Board of Pharmacy (the “Board”) voted to approve and finalize modifications to its proposed rule on shared services. The Board had initially published the proposed rule on June 10, 2022....more

McGuireWoods Consulting

Washington Healthcare Update - September 2023 #2

This Week in Washington: House stalls on defense spending bill, but begins negotiations among Republicans on appropriations; Senate was expected to move forward on three appropriations bills, but has now stalled; House to...more

McGuireWoods Consulting

Washington Healthcare Update - July 2023 #3

This Week in Washington: Senate Finance Committee reports out Modernizing and Ensuring PBM Accountability Act; House Ways and Means Committee reports out healthcare bills; Senate Appropriations Committee reports out FY 2024...more

McGuireWoods Consulting

Washington Healthcare Update - June 2023 #4

This Week in Washington: Senate Appropriations Committee meets to figure out top-line numbers; Majority Leader Schumer leads Senate in developing a policy response to artificial intelligence; and CMS proposes new Medicare...more

McGuireWoods Consulting

Washington Healthcare Update - June 2023 #3

This Week in Washington: FDA funding bill passes House Appropriations Committee, MedPAC and MacPAC release June 2023 report to Congress, RSC budget blueprint brings back premium support concept for Medicare...more

McGuireWoods Consulting

Washington Healthcare Update - June 2023

This Week in Washington: Debt-ceiling agreement passes, House Energy and Commerce Committee reports out legislation on site-neutral Medicare payments for certain drugs...more

McGuireWoods Consulting

Washington Healthcare Update - March 2023 #4

This Week in Washington: HHS Secretary appears before Senate Finance and Senate Appropriations Committees...more

McGuireWoods Consulting

Washington Healthcare Update - March 2023 #2

Upcoming Hearings - March 15 - Senate Committee on Veterans’ Affairs Hearing: “Examining the Future Path of VA’s Electronic Health Record Modernization Program” - 3:30 p.m., Dirksen Senate Building 106...more

McGuireWoods Consulting

Washington Healthcare Update - March 2023

This Week in Washington: Workforce issues studied, PBMs under more scrutiny...more

McGuireWoods Consulting

Washington Healthcare Update - January 2023 #3

This Week in Washington: House and Senate not in session, U.S. reaches debt-ceiling limit...more

McGuireWoods Consulting

Washington Healthcare Update - January 2023

This Week in Washington: 118th Congress begins, House finally chooses Speaker...more

McDermott Will & Emery

CMS Issues Broad-Ranging Medicare Advantage and Part D Proposed Rule

On December 14, 2022, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule regarding Contract Year 2024 Policy and Technical Changes to the Medicare Advantage (MA) and Medicare Prescription Drug Benefit...more

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