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Insights & Analysis

There’s one constant in healthcare: change. Count on us to break down the trends so you can stay up to date. Follow our take on each piece of this deep, intertwined, and often perplexing industry to find opportunities and practical approaches to move healthcare forward.

Laura Heller

FDA’s Priorities and Approach for Homeopathic Drug Products

On October 24, the FDA released a draft guidance describing the intended risk-based approach for regulatory actions toward homeopathic drug products marketed in the United States without the required FDA approval. The FDA has not approved a single homeopathic product thus far. The agency is currently restructuring its enforcement and regulatory priorities in this space.

Michael Kearney

Healthcare Organizations See Reduction in ED Visits and Inpatient Admissions when Focusing on Value

Avalere worked with a healthcare organization to assess the impact of their quality improvement program over a 4-year period. The organization prepared primary and specialty care providers/practices to transition from fee-for-service (FFS) to value-based payment arrangements. Avalere’s analysis found participation in the program led to a reduction in both emergency department (ED) visits as well as inpatient (IP) admissions over the period reviewed.

Sean Creighton

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.

Josh Seidman

Avalere Publishes Manuscript on Validating Preparation for Shared Decision-Making Tool for Advanced Breast Cancer Patients

Avalere’s “Preparation for Shared Decision-Making” (PFSDM) tool aims to help patients with advanced breast cancer (ABC) feel prepared to communicate with their clinicians and engage in decision making aligned with their preferences. The validation study confirms the acceptability and usability of the tool for women with ABC.

Nick Diamond

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.

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