CMS Seeks Input on Medicare Advantage Data, Implements Changes to Data Access and Use

Lauren Ahearn Lauren Ahearn is a quality and regulatory affairs associate at ASN.

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There are two major issues before the Centers for Medicare & Medicaid Services (CMS) involving Medicare Advantage (MA) data and research requests involving CMS data. Both issues are policy priorities for ASN. Updates for both follow.

CMS seeks public input on MA data collection and transparency

On January 30, 2024, CMS issued a request for information (RFI) seeking public input on data needed for Medicare Part C, known as the MA program (1). According to CMS, the goal of this RFI is to provide the agency with feedback on both the format and types of data that will allow CMS to have better insight into MA organizations and their operations (2).

This RFI follows a previous RFI released by CMS in August 2022 in which CMS sought feedback from the public on ways to strengthen the MA program and align it more closely with Medicare's vision and strategic pillars. CMS received more than 4000 responses to this RFI from a variety of stakeholders. A few key themes identified by CMS in these responses included the need for stronger beneficiary protections, payment issues, and programmatic data.

The follow-up RFI released this past January is notably broad; CMS states that it is seeking stakeholder input on “all aspects of data related to the MA program—both data not currently collected as well as data currently collected” (1). CMS's eventual goal is to align MA data with the data collected and available for Medicare Parts A and B. CMS believes stakeholder input gained from this RFI will help in the development of future rulemaking to address perceived shortcomings and to ensure transparency into MA organizations.

As MA enrollment continues to climb, policymakers are increasingly interested in aligning it with original Medicare. As of 2023, 30.8 million people are enrolled in an MA plan, accounting for 51% of the population eligible for Medicare and $454 billion (or 54%) of total federal Medicare spending (3). In 2016, the 21st Century Cures Act was passed, which granted patients with kidney failure the ability to enroll in MA plans starting in 2021. Since that enrollment period opened, it is estimated that 37.7% of beneficiaries with kidney failure are enrolled in an MA plan (4), and closer to 50% of all patients with kidney failure are enrolled in Medicare. The number of MA enrollees with kidney failure is expected to continue to rise, and ASN remains committed to ensuring that MA plans are required to adhere to the same regulatory standards and quality of care as is the traditional Medicare program. ASN has noted in previous letters to CMS regarding MA data that as more patients eligible for Medicare enroll in MA plans, it is crucial that the kidney failure-related data that are available for patients with Medicare Fee-for-Service as their primary coverage include MA enrollees, as this issue impacts the integrity of the US Renal Data System. Also, ASN advocated for stricter regulatory action related to overuse of prior authorizations in MA. ASN will continue to advocate for these changes in its response to the RFI, which is due May 29, 2024.

Major changes coming to CMS Research Identifiable File (RIF) access

On February 12, 2024, CMS announced significant changes to the method in which researchers gain access to data through its research data request and access policy (5). Previously, CMS offered researchers two options for accessing CMS RIF data: 1) Researchers could request that physical data extracts be shipped to their institution, or 2) researchers could access the data needed in the Chronic Conditions Warehouse Virtual Research Data Center (CCW VRDC), which CMS describes as a “secure CMS research environment.”

Beginning in the summer of 2024, all researchers requesting RIFs must access data within CMS's CCW VRDC environment and comply with CMS CCW VRDC policies. CMS is discontinuing the delivery of physical data extracts that support external research projects—only federal and state agencies may request an exception to this new policy. CMS has cited “growing data security concerns and an increase in data breaches across the healthcare ecosystem” as its reason for this change.

In addition to this policy change announcement, CMS also released a corresponding RFI on the proposed changes. The RFI asks numerous questions among five domains:

  1. CCW VRDV process/access

  2. CCW VRDC tools

  3. Data/project

  4. Data access fees

  5. Transition timing

CMS has stated that it will not be responding to individual comments on the RFI. Instead, it will be sending out additional guidance later this year and final guidance prior to requiring researchers to transition their ongoing research studies to the CCW VRDC.

ASN is working with other members in the kidney community to address the challenges that this proposal presents, including an exhaustive research fee list that begins with a $20,000 initial project fee and a $10,000 project renewal fee. Those fees would apply to every member of the research team who would work directly with the data.

The use of CMS data in research has had a significant impact on health care policy. In a letter from researchers across the country to CMS, voicing strong objection to the proposal, Zack Cooper, PhD, and Alexia Witthaus, BS, of Yale University, New Haven, CT, developed a list of high-impact scholarship that were derived from Medicare claims data including:

  • Formed the intellectual basis for the Affordable Care Act

  • Helped motivate the Medicare Hospital Readmissions Reduction Program

  • Informed and helped assess Medicare payment policy, including Accountable Care Organizations and bundled payments

  • Analyzed the efficiency of the MA program

  • Identified the causes of mortality differences across regions

  • Identified the causes of the opioid epidemic

  • Described the causes and consequences of variation in Medicare spending across the United States and identified strategies to address them

  • Documented racial disparities in the Medicare program

  • Identified the effect of private equity firms on the survival of Medicare beneficiaries

  • Illustrated how hospital competition and mergers impact mortality

  • Proposed strategies to identify and root out Medicare fraud

  • Documented how to measure providers’ quality and insurance plan quality

  • Described the presence of low-value care delivered to Medicare beneficiaries

ASN is committed to improving the policies outlined to date to protect valuable kidney research and other health care research conducted by using CMS data and will provide updates in Kidney News.