Legal Matters

CMS Innovation Center Releases New Strategic Priorities To Set Course for Second Decade of Operations

Michael T. Flood, J.D. David E. Bird, J.D. Polsinelli, PC

The Center for Medicare and Medicaid Innovation (“CMMI”) was established as part of the Affordable Care Act and gives the Secretary broad discretion to develop and implement payment models with the goal of achieving higher quality in the delivery of high value services at a lower cost to the Medicare and Medicaid programs. CMMI is responsible for administering many popular programs, including the Bundled Payments for Care Improvement Advanced, ESRD Treatment Choices Model, the Oncology Care Model, Expanded Home Health Value Based Purchasing Model, Million Hearts, and other value-based demonstration programs.

Through the years, CMS has made attempts to implement reforms to Part B drug payments through CMMI. This year, CMMI chose not to implement the Most Favored Nation Model Interim Final Rule (MFN Model) after several delays. The MFN Model was aimed at lowering the amount Medicare Part B pays for 50 high-cost drugs to the lowest price that drug manufacturers receive in similar countries. CMMI recently announced it rescinded the MFN Model as it “explore[s] all options to incorporate value into payments for Medicare Part B drugs, improve access to evidence-based care, and reduce drug spending for consumers and throughout the health care system.” No new Part B drug payment models have been proposed to replace the MFN Model.

Despite the ongoing implementation of demonstration models, perhaps the most notable development for CMMI was its release of a new strategic plan entitled the Innovation Center Strategy Refresh (“Strategic Plan”). The Strategic Plan is intended to guide CMMI’s health care payment and delivery model development and design priorities over the next decade. According to CMMI’s proposed timeline, the first three to six months of this plan’s implementation would be dedicated to stakeholder engagement.

Although CMMI’s overarching goal continues to be expansion of successful models that reduce program costs and improve quality and outcomes for Medicare and Medicaid beneficiaries, the Strategic Plan establishes the following objectives for CMMI: 1. Increase the number of Medicare and Medicaid beneficiaries in value-based care models by 2030.

CMMI has a goal that all Medicare

Part A and Part B enrollees and the vast majority of Medicaid enrollees will participate in care relationships with accountability for quality and total cost of care by 2030. 2. Advance Health Equity. Embed health equity in all models through mandatory reporting of demographic and social determinants of health data as appropriate. Ensure participation of historically underserved

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First U.S. Peer-Reviewed Study on Omicron Patient Outcomes Reveals Rapid Spread and Significant Differences in Infection Behavior

Results Also Uncover First Three Cases in Texas Of “Stealth Omicron” Among Houston Methodist Patients

Within only three weeks after the omicron variant was first identified among Houston Methodist patients, this variant rapidly took over and became the cause of a majority of new cases. By contrast, the delta variant took about three months to reach that same milestone after initial detection. Causing 98 percent of all new COVID-19 cases by the beginning of 2022, omicron had infected 4,468 of Houston Methodist’s patients by Jan. 5. In what is the first peer-reviewed U.S. study investigating omicron patients and their outcomes, Houston Methodist physician-scientists reveal that omicron patients are significantly younger, have increased vaccine breakthrough rates, are less likely to be hospitalized and have shorter hospital lengths of stay than patients with COVID-19 caused by the alpha or delta variants. Consistent with this decreased disease severity, patients infected with the omicron variant of COVID-19 required less intense respiratory support and had shorter hospital stays.

The findings of this study are described in a paper titled “Signals of significantly increased vaccine breakthrough, decreased hospitalization rates, and less severe disease in patients with COVID-19 caused by the Omicron variant of SARS-CoV-2 in Houston, Texas” appearing Feb. 3 in The American Journal of Pathology. James M. Musser, M.D., Ph.D., chair of the Department of Pathology and Genomic Medicine at Houston Methodist, is the corresponding author on the study.

Compared to Houston Methodist patients infected with alpha or delta variants, the median age of omicron patients was 44.3 years, compared to ages 50 for alpha and 48.3 for delta; length of stay for hospitalized patients was 3.2 days for omicron, 5.1 days for alpha and 5.4 days for delta; and omicron resulted in 55.4% of breakthrough cases in vaccinated patients, whereas only 5.4% and 0.9% of vaccinated patients were infected with the alpha and delta variants, respectively.

As of mid-January, the researchers have also identified three patients with the BA.2 “stealth omicron” variant, which requires whole genome sequencing to distinguish it from delta and the original BA.1 omicron strain. These were the first three “stealth omicron” cases discovered in Texas.

Houston Methodist has one of the largest, most comprehensive SARS-CoV-2 virus genome sequencing studies in the country, analyzing the genome of every positive COVID-19 sample identified throughout Houston Methodist’s hospital system. To get ahead of the virus and detect mutations that affect patient outcomes, such as causing more severe disease or detrimentally impacting treatments and vaccines, Houston Methodist has sequenced nearly 80,000 SARS-CoV-2 virus genomes since the beginning of the pandemic.

Houston Methodist has sequenced nearly 80,000 SARS-CoV-2 virus genomes since the beginning of the pandemic.