June 2nd, 2008
From its inception, the Medicare Modernization Act has simmered with the contradictions implicit in its mixed parentage. It is at once the most ambitious new U.S. human welfare program of the millenium; and at the same time a great ragbag of absurdities, from the loopy benefit structure to a wilderness of obscure and convoluted arrangements for rewarding the government’s private-sector partners.
Not least among these grotesqueries, although among the least noticed, has been the crypt-like sequestration of administrative data from the Part D program. Most Part D data have been unavailable not only to independent researchers in academia and the think tanks but also to the government agencies responsible for monitoring expenditures of the public’s money and the performance of tax-supported activity, including Congress, the Government Accountability Office (GAO), the Congressional Budget Office (CBO), and the Medicare Payment Advisory Commission (MedPAC). They’ve all been flying blind with our $500 billion.
“We have this big new program and no way of knowing how well it’s performing, how beneficiaries are affected,” said MedPAC executive director Mark Miller at a February briefing. The unanswered questions include “which prescription drugs enrollees are using most widely; how much, on average, enrollees are paying out of pocket for their medicine; and how many beneficiaries are entering Part D’s coverage gap. Other federal agencies need Part D data to carry out postmarketing surveillance of drug safety and efficacy, to help monitor the prevalence and treatment of specific conditions, and to support research on clinical outcomes and the effectiveness of covered drugs,” said MedPAC’s March report, which called on Congress to direct the Centers for Medicare and Medicaid Services (CMS) to release more Part D data.
CBO director Peter Orszag made a similar appeal a few weeks earlier. “In exchange for this publically funded set of experiments we should be getting a set of rigorous data back on what works and what doesn’t,” Orzag said in January. But it hasn’t happened that way, “even though I continue to beg for that data.” The data restrictions were outlined in detail last year by Leslie Greenwald of RTI International in the journal Medical Care, and have been the subject of occasional reports in the trade press.
CMS issued a proposed rule for making more Part D data available in October 2006, on Mark McClellan’s last day as the agency’s administrator. But the proposal has languished ever since. Last week, finally, the lid came off – perhaps by the grace of Orszag’s appeals and MedPAC’s March recommendation. Significant limitations may still apply where proprietary information or privacy concerns are at stake. But after immoderate delays, it appears that pertinent public agencies and independent analysts will finally have their hoods removed.
The editors of this journal, and its readers, will have good cause to join in celebrating issuance of the final rule. For the past three years, the journal has received a steady stream of manuscript submissions on MMA, many of them of excellent quality, which have nevertheless been hamstrung by the lack of adequate data access. Researchers have been dependent on simulations and the voluntary release of data by plans, drug manufacturers, and pharmacy benefit managers. These studies have been better than nothing, but they are unavoidably clouded by the potential bias of the private interests who choose to release their limited data sets.
We look forward to a palpable clearing of the air.Email This Post Print This Post