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.

2020 Election: Healthcare Coverage Landscape Varies in Early Primary States

As the early presidential primaries unfold, healthcare remains a top issue among voters. As recently as the November Democratic primary debate, polls showed that 24% of Democrats or Democratic-leaning independents said healthcare was the number one issue they wanted to hear discussed, ahead of the environment (12%), immigration (6%), jobs and the economy (5%), education (4%), and gun control (4%).

CMS’s Healthy Adult Opportunity Program Includes Significant Changes to Medicaid Drug Benefit

The Centers for Medicare & Medicaid Services (CMS) announced the Healthy Adult Opportunity, a new Section 1115 demonstration initiative allowing states to shift toward capped Medicaid financing models with an opportunity for shared savings. If the option is chosen by states, it could be the largest change to Medicaid since the ACA.

Avalere Statement on CMS’s Healthy Adult Opportunity Program

CMS’s Healthy Adult Opportunity program, a new Section 1115 demonstration initiative, will allow state Medicaid programs to move toward capped financing models for some non-disabled adult beneficiaries with an opportunity for shared savings and additional flexibilities.

MSSP Sees Continued Growth in Downside Risk ACOs

New analysis from Avalere finds that more accountable care organizations (ACOs) participating in the Medicare Shared Savings Program (MSSP) have assumed downside risk as the program matures, with the greatest growth over the past 3 years.

Omar Hafez

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On October 24, the FDA released a draft guidance describing the intended risk-based approach for regulatory actions toward homeopathic drug products marketed in the United States without the required FDA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.

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.

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.

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.

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.

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