The U.S. Department of Health and Human Services is poised to adopt a policy that could prove devastating to research aimed at improving health care — that's the takeaway shared by critics of a Centers for Medicare & Medicaid Services planned policy change that will severely restrict the ways researchers can access Medicare and Medicaid data by way of a much pricier and less flexible option. APTA is voicing its opposition to the change, echoing a group of prominent researchers who describe the limitations and increases as "incredibly detrimental to public health and scientific progress in the United States."
At issue: the mechanisms by which CMS makes data available for research. Currently, the agency offers both physical access to claims data, securely held at research institutions, as well as digital, cloud-based versions via the Chronic Conditions Warehouse Virtual Research Data Center, or CCW VRDC. In a surprise move, the agency announced that it would no longer deliver physical extracts in support of external research projects. This leaves researchers with only the cloud-based version, which requires payment of a $20,000 initial project fee followed by annual $10,000 project renewal fees.
Fewer Options, Less Adaptability, More Cost
While paying for CMS data isn't new, the physical extract option carried a lower initial project cost, didn't impose renewal fees, and could be accessed by multiple researchers working on a project. The change forces researchers to use the more expensive option, which levies the $20,000 fee for each user and has the added detriments of being less user-friendly, with a smaller server capacity and limited suite of analysis software.
The change sparked outcry among health researchers who rely on CMS data for their studies of clinical interventions, health policy, patient populations, and more. The data, they argue, is crucial for advancing research to improve health care, but restrictions on access — and the unaffordable price tag — will chill that work.
In a letter to CMS Administrator Chiquita Brooks-LaSure, a group of more than 375 prominent researchers from institutions across the U.S. decried the move as one that "jeopardizes the accountability of the entire healthcare system in the US through research that needs to be rigorous, reproducible, and conducted with academic freedom."
Elsewhere in the letter, the researchers write, "Dampening the research and training of future scholars will directly translate into Medicaid and Medicare beneficiaries missing out on improvements in health care driven by this research. It will disproportionately dissuade research by and training of scholars from disadvantaged backgrounds. It risks threatening the health of the CMS beneficiaries and the viability of the Medicare trust funds in the long run."
A Danger to 'Even the Most Well-Funded Researchers'
Rachel Prusynski, PT, PhD, a prominent physical therapy researcher at the University of Washington School of Medicine who signed on to the letter, says the scope of the data affected by the change is massive.
"These changes apply to all large patient-level Medicare and Medicare Advantage datasets, which are used by hundreds of researchers, consultants, and advocacy groups around the country to study the delivery of care, outcomes of care, and costs of care for over 65 million Medicare patients annually," Prusynski said. "They include everything from hospital stays to postacute care stays plus all outpatient visits including physician and physical therapy visits. The datasets also include important diagnostic and demographic information that allows researchers to look at issues of equity or gaps in care and care outcomes. Hundreds of studies are published annually with these datasets, and large data studies are crucial when providing feedback to Medicare on policy changes, adequacy of reimbursement, or patient outcomes."
And while the datasets won't vanish, access could be a practical impossibility for many researchers — including those affiliated with well-funded institutions, and especially when accessed for purposes of educating the next generation of researchers, according to Prusynski, who sees the change as detrimental to both future and ongoing research.
"Researchers across the country will either lose access to data they’ve been securely storing and working with for years, or they will have to pay potentially hundreds of thousands of dollars to maintain access to data for their research teams," she said. "The fees for new data requests will frequently exceed typical budgets for even the largest NIH grants, and because the new policies require per-person and per-project fees, even the most well-funded researchers will no longer be able to provide access to the data for students and trainees. This will have negative implications for the pipeline of new researchers and disproportionately impact early-career researchers and those at public institutions with fewer resources."
APTA Will Weigh In — And Encourages Members to Do the Same by March 29
APTA opposes the data access change and will provide its input in collaboration with other stakeholders by CMS' March 29 request for information deadline. The association urges anyone affected by the restrictions to provide feedback as well. The agency posted guidelines for responding to its request for feedback; those comments should be sent to VRDCRFI@cms.hhs.gov.
Rachel Miller, MPH, APTA health policy and payment specialist, says that the new policies not only undermine research efforts but also run contrary to one of the goals frequently touted by the department.
"The Biden administration has repeatedly called for more health data transparency, and HHS has responded by saying that it's committed to carrying out that mission," Miller said. "These restrictions, which will actually make access to data more difficult, costly, and inefficient, are a harmful move in the exact opposite direction."