The Centers for Medicare & Medicaid Services (CMS) issued a final rule allowing Part D claims data currently being collected for payment purposes to be used also for program monitoring, research, public health functions, care coordination, quality improvement, population of personal health records (PHR) and other purposes. The final rule (CMS-4119-F) takes effect June 27 and applies to Part D claims data collected on or after Jan. 1, 2006. CMS says this data will also be used to better identify, evaluate and measure the effects of the Medicare Modernization Act (MMA) of 2003, including the prescription drug benefit and its impact on health outcomes. CMS notes that because the final rule applies to all Part D sponsors, it applies to any entity that offers a Part D plan.
The Part D prescription drug event data collected will include not only data from claims for drugs, but also data from claims for insulin, biological products, certain medical supplies and vaccines. The final rule gives CMS authority to release the Part D claims data to other federal government agencies, states, external researchers and beneficiaries for their PHRs. According to CMS, it will not release beneficiary, prescriber or pharmacy identifiers to other government agencies or external researchers unless these are "absolutely necessary for study." Where identifiers are disclosed to external researchers, CMS says it will ensure that all applicable privacy and security protections are in place, such as ensuring all electronic transmissions are encrypted.
CMS also believes researchers studying a broad range of topics need access to Part D claims linked to Parts A and B claims data. In order for these researchers to conduct studies related to improving quality and reducing costs of care for chronically ill Medicare beneficiaries, CMS is implementing section 723 of the MMA, which requires CMS to develop a plan to "improve the quality of care and reduce the cost of care for chronically ill Medicare beneficiaries." Section 723 of the MMA calls for populating a chronic care condition data warehouse that will be accessible by private researchers.
CMS will require external researchers to sign a Data Use Agreement (DUA) that outlines certain restrictions be placed on the data, including a requirement that, once a project is completed, the data must be destroyed with no copies retained. CMS says it will build on its existing safeguards for other Medicare data through a process that: 1) provides only the minimum data necessary to complete a study; 2) requires the results of the research to reside in the public domain; and if an external entity is involved, 3) requires the researcher have the requisite experience and be working in a "reputable" institution. CMS states that it does not believe the new costs associated with compliance under the new regulation, if any, will be significant. Furthermore, it expects risk and compliance burdens to be limited, and that under its data release policies, CMS will not allow the release of Part D claims data for commercial purposes.
According to CMS, the provisions of the final rule are important to the health of Medicare beneficiaries because, to date, its understanding of how well drugs work and how safe they are for the elderly or disabled has been limited. CMS points out that clinical trials often exclude the very old; patients with multiple chronic conditions; and, those taking multiple medications, which comprise the vast majority of Medicare beneficiaries. It says these data will provide a critical new source of information about how these drugs work, and their safety in elderly and disabled populations.
An open door forum is being conducted this month (June) to review the final rule, discuss the Part D claims data release process, and answer questions from the public. Click here to participate in the open door forum. To read the CMS Medicare program/Medicare Part D final rule (42 CFR Part 423) on the Federal Register, click here.