The rule, authorized under the Affordable Care Act, is available here with publication in the Federal Register on Dec. 7. "This rule explains how entities can become qualified by CMS to receive standardized extracts of claims data under Medicare Parts A, B and D for the purpose of evaluation of the performance of providers and suppliers," according to the rule. "This rule also lays out the criteria qualified entities must follow to protect the privacy of Medicare beneficiaries."
In response to public comments, the rule enables use of clinical data combined with claims data from Medicare and elsewhere when calculating standard and alternative measures. CMS accepted arguments of the added value that clinical data brings to performance measurement.
"We have added a definition of clinical data at Sec. 401.703(i), specifically clinical data is registry data, chart-abstracted data, laboratory results, electronic health record information, or other information relating to the care or services provided to patients that is not included in administrative claims data," according to the rule. "Measurement efforts using clinical data would only be supported under the qualified entity program if the clinical data is combined with the qualified entity's Medicare and other claims data to calculate the measures. These regulations do not address the use and publication of purely clinical-based measures."
CMS also authorized use of an identifier to link claims and clinical data. "Furthermore, we recognize the near impossibility of combining Medicare claims data with clinical data without an identifier to link them. As a result, we are changing the proposed process for releasing beneficiary identifiable information to allow--with strict privacy and security standards--for the disclosure of identifiers to qualified entities."
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