Log in or register
Share on LinkedInShare on LinkedIn

ARTICLE · 07 OCTOBER 2008

CMS Final Rules Affect Medicare Marketing, Implement MIPPA Changes

McDermott Will & Emery
Explore more from McDermott Will & Emery

New regulations took effect September 18, 2008, so Plan Sponsors must rapidly adopt operational changes in order to comply with the regulations in time for the launch of 2009 marketing on October 1, 2008.

United StatesFood, Drugs, Healthcare, Life Sciences
Ankur Goel
Ankur Goel
Anne Hance
Anne Hance
Joel Michaels
Joel Michaels
Author LinkedIn connections

New regulations took effect September 18, 2008, so Plan Sponsors must rapidly adopt operational changes in order to comply with the regulations in time for the launch of 2009 marketing on October 1, 2008.

The Centers for Medicare and Medicaid Services (CMS) released two final rules on September 15, 2008, that adopt in final form regulatory provisions implementing strict marketing restrictions and other operational aspects for the Medicare Advantage and Part D Programs (the Programs). All of these regulatory provisions take effect on September 18, 2008, the date the rules were published in the Federal Register.

The new regulations adopt, in large part, changes to the Programs proposed by CMS in May 2008 as well as changes implemented by the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), such as restrictions on agent/broker compensation; restrictions on marketing activities, including at provider locations; provider network requirements for

We operate a free-to-view policy, asking only that you register in order to read all of our content. Please login or register to view the rest of this article.

Register for freeORLog in

Related Articles

Legal Intelligence Newsletters: sign up for the latest legal and regulatory news on your chosen topics

Read more about

Related Comparative Guides

See more popular content from

Article

Peptides At A Crossroads: What Wellness Providers Need To Know About HHS And FDA Actions

The U.S. Department of Health and Human Services and FDA have submitted an interim access policy for peptide compounding to regulatory review, but no peptides have yet been added to the official list allowing pharmacies to compound them. While advisory committee votes in July 2026 recommended six peptides for inclusion, formal rulemaking has not begun, and any near-term access would likely come through temporary enforcement discretion rather than full approval.
United StatesFood, Drugs, Healthcare, Life Sciences
Holland & Knight
Holland & Knight
Article

Federal Regulators And State Boards Crack Down On RUO Peptides

The FDA has escalated enforcement against online peptide sellers through warning letters and criminal prosecution, while state medical boards impose stricter standards on prescribers. Recent actions reveal how research-use-only disclaimers fail when evidence shows intended human use, and one case resulted in a 70-month prison sentence combined with $5 million forfeiture.
United StatesFood, Drugs, Healthcare, Life Sciences
McDermott Will & Schulte
McDermott Will & Schulte
Article

Proposed AI Governance Framework: Risk-Mitigation Recommendations For Health Plans

Senator Maria Cantwell has proposed a comprehensive AI governance framework that could fundamentally reshape how health insurance plans deploy artificial intelligence in prior authorization and utilization management. With explicit focus on CMS's WISeR model and requirements for meaningful human oversight, the framework signals potential federal mandates that would require health plans to audit AI systems, ensure transparency in consequential decisions, and maintain accountability for AI-related harms.
United StatesFood, Drugs, Healthcare, Life Sciences
Crowell & Moring LLP
Crowell & Moring LLP
Article

FDA Balances Peptide Policy With Enforcement Against Unlawful Peptide Sellers

Over the past year, industry has had a front row seat as the Food and Drug Administration (“FDA” or the “Agency”) decides just how much leeway it wants to afford the manufacture, marketing, and sale of peptide products, and just where it wants to draw the line. Despite the recent decision of FDA’s Pharmacy Compounding Advisory Committee (“PCAC”) to recommend a number of peptides for inclusion on the 503A bulks list process — a move that represents a potentially more permissive stance toward peptide regulation, at least in terms of what can and cannot be compounded under 503A...
United StatesFood, Drugs, Healthcare, Life Sciences
Sheppard
Sheppard
Article

Pharmaceutical Policy In Motion Continued: The Trump Administration’s Second Wave Of Drug Pricing Deals

The Trump administration's most-favored-nation pricing initiative has expanded to include nine additional mid-sized pharmaceutical manufacturers, bringing the total coverage to 89% of the brand drug market. These new agreements focus on Medicaid pricing discounts aligned with international rates, while manufacturers commit billions to U.S. manufacturing and research in exchange for exemptions from future pricing mandates and potential tariffs.
United StatesFood, Drugs, Healthcare, Life Sciences
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.