skip to Main Content

Federal & State Policy

As the largest, single US healthcare payer, the government plays a dominant role in shaping the healthcare marketplace. Our experts track, interpret, and model federal and state policies that affect insurance coverage, access, and consumer choice so you can see around the bend.

Right-to-Try Bills Grow in Popularity yet Success Is Unclear

Almost every state has introduced Right-to-Try bills to try to offer patients another avenue to access investigational drugs outside of the Food and Drug Administration's (FDA) expanded access program. However, it is unclear whether these laws will impact patient access given their questionable legal standing, reduced patient protections due to lack of FDA oversight, and the risks to manufacturers of providing products under Right-to-Try laws.

Webinar: Avalere and Inovalon Webinar: Understanding the CMS Advance Notice

The Centers for Medicare & Medicaid Services (CMS) will release the Advance Notice and Call Letter describing CMS' proposed 2017 payment policies for Medicare Advantage (MA) plan sponsors on February 19. Based on previously released information in the fall of 2015, CMS is likely to propose modifications to the risk adjustment model and the current MA Star Ratings methodology.

Veterans Administration and California Medicaid Drug Lists Cover Less than 60 Percent of Drugs Available to California Public Employees

The CalPERS Basic Plan Drug List, which is the formulary for all California public employees, includes 222 brand drugs and 287 generic drugs. In contrast, drug coverage in the Veterans Administration (VA) and Medi-Cal (California's Medicaid program) is far more limited than the CalPERS drug list.

New Study Analyzes FDA Advisory Committees’ Trends in First Three Years of Current User Fee Era

The U.S. Food and Drug Administration's (FDA) Advisory Committee (AdComm) process remains a source of significant uncertainty for medical product manufacturers, despite FDA's guidelines in the Code of Federal Regulations (C.F.R.)1 and in guidance.2 While the AdComm process is generally the same across Centers,3 each AdComm is unique and subject to the expertise and opinions of individual panel members, opinions voiced during the public comment period, and challenges exclusive to each new product or indication.

Podcast: Compassionate Use

When life sciences companies consider whether to allow compassionate use—access to unapproved investigational treatments outside of clinical trials—there are no easy answers. Brenda Huneycutt gleans insight from Arthur Caplan, PhD, and Alison Bateman-House, PhD, from the New York University Langone Medical Center Division of Medical Ethics on some of the many questions that life sciences companies should ask themselves before implementing a compassionate use policy.

MACRA and the Promise of Better Patient/Family Engagement in Post-SGR World

The story of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) actually begins in the previous millennium. In 1997, when the Congress passed the Balanced Budget Act, it ushered in the era of the Sustainable Growth Rate (SGR) formula. In theory, the SGR payment adjustment would raise or lower physician reimbursement each year based on spending relative to the target SGR. The caveat, however, was that Congress had the authority to suspend or adjust this benchmark, a "patch" that they regularly deployed through a "doc fix" for nearly two decades.

Back To Top