CMS FLOATS TRIAL BALLOON FOR PART D DATA SHARING INITIATIVE
The Centers for Medicare & Medicaid Services (CMS) is using a proposed rule issued Oct. 17 to test the legal waters for its plan to collect and share prescription drug plan data to base Medicare reimbursements on product comparisons, sources say.
The proposed rule would require any entities offering prescription drug coverage under the Medicare Rx law to provide the CMS with data about the products they offer, including drugs, biologics and medical devices, as part of their contracts with the government. "Through the appropriate use of the new prescription drug claims data, we have an unprecedented resource to help us learn more about prescription drug usage by seniors and how we can help seniors get the most benefit from prescription drugs," former CMS Administrator Mark McClellan said.
The CMS would then use the data, which includes various measures of the products' cost, to improve the workings of the Medicare program, according to the rule. The agency would also share this data with the FDA to "provide protection against adverse drug events" and with HHS' Agency for Healthcare Research and Quality's (AHRQ) to do comparative drug studies.
This development comes weeks after the initiative seemed dead because of questions regarding CMS' statutory authority. The agency is using the proposed rule to make legal arguments supporting the policy. "We are engaging in this rulemaking in order to resolve the statutory ambiguity," the rule said.
The agency believes that it has "broad authority" under the Medicare Rx law to share such data. Section 1860D-12(b)(3)(D) of the law provides the HHS secretary with the authority to "collect a broad array of data in order to properly carry out his responsibilities," the rule said. But the section also limits use of the data to work necessary to carry out the act.
However, the agency believes the law gives it some leeway, saying that if the secretary believes it is necessary and appropriate to carry out responsibilities even outside the scope of the section, he has the authority to do so.
The proposed rule prompted a strong response by both supporters and opponents of comparative trials. Peter Pitts, director of the Center for Medicine in the Public Interest and a former FDA associate commissioner for external relations, said the rule is the foundation for cost-based medical coverage that shortchanges the public and "sets an extremely dangerous precedent." The CMS is "trying to take authority away from the doctors and give it to the accountants."