Why this Newsletter 

The Center of Medicare and Medicaid Services (CMS) recently proposed regulation (Section 422.101) directed towards commercial insurance Medicare Advantage (MA) health plans.  This information could be of interest to those companies who are developing or selling medical technologies designed for the Medicare population.


CMS’s proposed regulation is relevant because it would codify standards to ensure transparency in each MA plan’s internal coverage criteria and decision-making process as well as medical necessity determinations.

First CMS’s proposal proposes codify standards for internal coverage criteria. This is  intended to ensure each MA plan’s basic benefits coverage for their MA enrollees is no more restrictive than Traditional Medicare.  To date, this requirement has primarily been set through sub-regulatory guidance.

Second CMS’s proposal includes clarification related to making individual medical necessity determinations.  MA plans may not deny coverage to a Medicare enrolled for basic covered benefits based on criteria that are not set forth in policies that meet the requirements of section 422.101.

Finally, CMS’s proposal includes the requirement (422.101(b)(6)) that MA plans provide a publicly accessible summary of the evidence considered in developing coverage criteria for an item (drug, medical device etc) or service (hospital admission, telepathology etc), a list of the sources of the evidence, and an explanation of the rationale supporting, or not supporting,  the adoption of the criteria based upon the evidence.

Collectively CMS’s proposed regulation (Section 422.101) intent is to improve public transparency, uniformity thereby enhancing MA plans’ accountability to CMS.


About Rowinski Group   

Founded in 2004, Rowinski Group LLC is a reimbursement and healthcare payer data analytics consultancy for medical device, digital health, diagnostics companies. Rowinski Group has offices in the   Silicon Valley – San Francisco Bay area and Chicago, Minneapolis, and Raleigh.

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Rowinski Group has two core service offerings; securing codes and reimbursement on behalf of companies and applying healthcare payer data analytics to help companies solve business issues such as responding to questions from the FDA and Medicare, sales forecasting etc.

Through these service offerings Rowinski Group helps U.S. and international companies build their U.S. market share for the medical technology they are developing and selling. For more information, visit. https://reimbursement.consulting  or contact Daniel Zimmerman d.zimmerman@reimbursement.consulting


About Women’s Business Enterprise National Council (WBENC)  

Founded in 1997, WBENC is the nation’s leader in women’s business development and the leading third-party certifier of businesses owned and operated by women, with more than 13,000 certified Women’s Business Enterprises, 14 national Regional Partner Organizations, and over 300 Corporate Members.

More than 1,000 corporations representing America’s most prestigious brands as well as many states, cities, and other entities accept WBENC Certification. For more information, visit www.wbenc.org.