Federal and State Policy

As the largest US healthcare payer, the federal government plays a dominant role in shaping the healthcare marketplace, while states take center stage when it comes to developing novel policy approaches. Our experts track, interpret, and model policies that affect insurance coverage, access, and consumer choice so you can see around the bend.

Device Regulation Modernization Efforts Continue to Accelerate

The Food and Drug Administration’s (FDA) efforts to modernize medical device oversight in the agency’s Center for Devices and Radiological Health (CDRH) have continued with the release of multiple draft and final guidances in 2019, as well as a plan for additional releases in 2020.

CMMI’s Financial Impact on Medicare Spending Challenging to Project (Updated)

CMMI’s impact on Medicare spending has not reached earlier projections by the Congressional Budget Office (CBO), demonstrating the difficulty in projecting savings from untested and future unknown alternative payment models

CMS RADV White Paper Outlines Potentially Significant Program Changes

CMS is considering changes to its commercial market Risk Adjustment Data Validation (RADV) program to improve the accuracy of risk adjustment transfers and to increase stability and predictability for issuers. This follows issuer experiences with the 2017 RADV process in which some issuers saw substantial, unforeseen changes to their risk adjustment transfers. These RADV changes have the potential to impact issuer participation and premiums in future years depending on the direction (positive or negative) and magnitude of those transfers.

USMCA Compromise Drops Key Biologics Exclusivity Provisions

The replacement to North American Free Trade Agreement (NAFTA), the United States-Mexico-Canada Agreement, was originally proposed to increase biologics exclusivity in Mexico and Canada to 10 years. As part of the Administration’s compromise with the House of Representatives, these provisions have been removed from the amended version that was recently agreed to by the US, Mexico, and Canada. While exclusivity in the US remains unchanged at 12 years, that it is not increased for Canada and Mexico may impact market entry for biologics ex-US.

Natascha Dixon Edelin

Webinar: Get the 411 on Healthcare Consulting

Are you interested in a career in healthcare consulting? Are you passionate about solving the challenges of the healthcare system? Avalere Health, a leading healthcare consulting firm, held an informational webinar on November 18 to provide information about the company and our Associate Immersion Program.

Policy and Market Access Trends in Kidney Care

A shifting policy landscape and emerging market forces could introduce significant disruption in the kidney care space in the coming years. Understanding the risks and opportunities that these changes may present will be critical for patients, providers, payers, and manufacturers alike.

2019 State Elections: What to Watch in Healthcare Policy

Healthcare policy remains a top priority for both voters and policymakers in 2019 and has been a key part of campaign platforms.

5 Key Trends from the 2020 CMS Star Ratings Report

Join Avalere experts on our webinar on October 29, 2019, to unpack CMS’ 2020 Star Ratings and look at what’s to come for 2021.

3 Trends to Watch in this Medicare Open Enrollment Season

As Medicare Advantage enrollment grows and benefits continue to evolve, beneficiaries must keep pace with these changes and investigate plan options amidst current healthcare debates.

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