News & Analysis as of

Final Rules Medicare Part D Department of Health and Human Services (HHS)

Lathrop GPM

Flying Through the Whirlwind: Health Care Industry Continues To Be Buffeted as Administration Rolls Out New Initiatives

Lathrop GPM on

Health care providers and payers have been subject to a flurry of developments at the federal level in recent weeks. Considering that health care represents almost 18% of the U.S. gross domestic product, this was perhaps...more

Verrill

Prepare for Cooler Weather, Annual Enrollment, and 2025

Verrill on

Summer is ending and fall is rapidly approaching. For employee benefit professionals with calendar-year health and welfare benefit plans that means preparing for annual enrollment and year-end compliance requirements. This...more

Sheppard Mullin Richter & Hampton LLP

Texas Court Stays CMS CY2025 Final Rule on Agent and Broker Compensation and Contract Term Restrictions

On July 3, 2024, a federal court in Texas stayed provisions of the Centers for Medicare & Medicaid Services’ (“CMS”) contract year 2025 Final Rule that amended the longstanding Medicare Advantage (“MA”) and Part D agent and...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | April 2024 Recap

McDermott Will & Emery on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the Calendar Year (CY) 2025...more

McGuireWoods Consulting

Washington Healthcare Update - April 2024

This Week in Washington: Senate HELP Committee Chairman requests comments on Long COVID draft proposal; CMS announces proposed Transforming Episode Accountability Model; CMS releases FY2025 Inpatient and Long-Term Care...more

Holland & Knight LLP

Holland & Knight Health Dose: April 9, 2024

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

Holland & Knight LLP

Holland & Knight Health Dose: March 5, 2024

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

McGuireWoods Consulting

Washington Healthcare Update - December 2023 #3

McGuireWoods Consulting on

This Week in Washington: House passes Lower Costs, More Transparency Act and SUPPORT Act Reauthorization; Senate HELP Committee reports SUPPORT Act Reauthorization and three other bills out of committee; ONC releases final...more

Ankura

Updates to the Translation and Accessibility Standards for Required Materials and Content in the Medicare 2024 Final Rule

Ankura on

Medicare Advantage Organizations and Part D sponsors have a responsibility to ensure they offer and provide their members and potential enrollees with content and materials in alternate languages or accessible formats for...more

McGuireWoods Consulting

Washington Healthcare Update - August 2023

This Week in Washington: HHS announces lowest national uninsured rate, CDC recommends RSV antibody for infants, CMS releases rules on inpatient and long-term care hospitals and skilled nursing facilities...more

McGuireWoods Consulting

Washington Healthcare Update - May 2023 #2

This Week in Washington: Debt Ceiling Continues to Loom Over the Capitol; DEA Extends COVID-19 Controlled Medications Prescribing Telehealth Flexibilities...more

King & Spalding

New Medicare Advantage Regulations Add Provider and Beneficiary Protections Against Plan Utilization Management Policies

King & Spalding on

On April 5, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a Final Rule (CMS-4201-F) regarding the Medicare Advantage (MA) and Part D programs. The Final Rule includes changes related to various aspects of...more

McGuireWoods Consulting

Washington Healthcare Update - February 2023

This Week in Washington: President Biden announces ending date of COVID-19 PHE, House begins investigations into COVID-19 origins; State of the Union scheduled for Feb. 7...more

McGuireWoods Consulting

Washington Healthcare Update - January 2023 #4

This Week in Washington: Fighting over how to proceed on the debt limit; Congress still finalizing committee assignments...more

ArentFox Schiff

Drug Pricing Reform Finally Becomes Law: What the Inflation Reduction Act Means for Pharma

ArentFox Schiff on

After many years of policy debate and attempts at proposed legislation, some of the most meaningful changes to the ways in which Medicare pays for prescription drugs – and the obligations of manufacturers selling drugs to...more

McGuireWoods Consulting

Washington Healthcare Update - February 2022 #3

Congress - The House is in a district work period this week. The Senate is in a state work period this week. Senate - Short-Term Continuing Resolution Passes Senate and is Signed by the President - On Feb. 18,...more

McGuireWoods Consulting

Washington Healthcare Update - February 2022 #2

This Week in Washington: Continuing Resolution Moves Forward and Senate Sets Up Vote on FDA Commissioner Nomination this Week...more

McGuireWoods Consulting

Washington Healthcare Update - February 2022

Upcoming Hearings/Markups - February 8 - Senate Health, Education, Labor and Pensions Committee Hearing: “Lessons Learned from COVID-19: Highlighting Innovations, Maximizing Inclusive Practices and Overcoming Barriers to...more

McGuireWoods Consulting

Washington Healthcare Update - January 2022 #3

This Week in Washington: President Biden and Speaker Pelosi Open to Moving Pieces of the Build Back Better Act....more

McGuireWoods Consulting

Washington Healthcare Update - January 2022 #2

This week in Washington: Supreme Court Rules on Biden Administration Vaccine Mandates....more

ArentFox Schiff

Arent Fox's Stark & Anti-Kickback Statute Final Rules Analysis

ArentFox Schiff on

Click the link below for our complete analysis of recent updates to the Stark Law and Anti-Kickback Statute and their impact on health care providers. ...more

King & Spalding

Implementation of Final Rule Excluding PBM Rebates from Discount Safe Harbor Delayed Until 2023

King & Spalding on

Pharmaceutical Care Management Association (“PCMA”) lawsuit results in delayed implementation of Final Rule while Biden Administration review is ongoing - Pursuant to a Court Order, implementation of the U.S. Dept. Health...more

ArentFox Schiff

What Should Pharma Companies Expect From the Biden Administration?

ArentFox Schiff on

With the change of administrations typically comes a flurry of activity across all government agencies, and the same can be expected with the official start of the Biden Administration now well underway. What should...more

Sheppard Mullin Richter & Hampton LLP

Medicare Part B Most Favored Nation Drug Pricing Model: New Rules, New Lawsuits, New Tweets

On September 13, 2020, President Trump issued an Executive Order (the “Executive Order”) directing the Department of Health and Human Services (“HHS”) to issue regulations instituting two most-favored-nations (“MFN”) payment...more

White & Case LLP

Trump Administration’s Eleventh-Hour Drug Pricing Regulations Face an Uncertain Path Forward

White & Case LLP on

The Trump Administration recently announced two final rules that implement policy objectives to lower drug prices by tying certain Medicare Part B payments to prices paid by other countries and by replacing an anti-kickback...more

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