McClellan is seeking input from experts from FDA advisory committees, the Institute of Medicine, and the Agency for Healthcare
Research and Quality to help set research priorities. Clinical researchers who focus on particular diseases also could identify
key study issues. For example, CMS is collaborating with the American College of Cardiology and the Heart Rhythm Society to
identify ways to use Medicare claims data in evaluating treatment of heart failure; similar analyses could be done by the
National Cancer Institute's Clinical Trials Cooperative Program, which supports thousands of interconnected cancer research
Access to Medicare data also would reduce the cost of comparative and outcomes studies by the Centers for Education and Research
on Therapeutics and other research networks and individual experts. A CMS "open-door forum" this month seeks comments from
stakeholders on the technical, regulatory and practical issues involved in such research activities.
Setting Data Standards
CMS expects to expand its information resources even more by linking to electronic data on drug use, health outcomes, and
overall costs of care assembled by PBMs and health plans serving both Medicare and under-65 patients. While McClellan is not
looking to actually pool all these data, he supports the idea of developing standards and frameworks for all segments of the
US healthcare system for health utilization and payment data to be collected in a "consistent" manner.
This fits with government-wide efforts to establish a national health information system. Such a system would use electronic
medical records, electronic prescribing, and health information technology (HIT) in order to allow all parts of the nation's
healthcare system to communicate. Health and Human Services (HHS) secretary Michael Leavitt recently added his support for
such initiatives as members of Congress began to roll out bipartisan legislation to accelerate HIT development.
Medicare is doing its part to encourage hospitals and physicians to invest in HIT. In exchange for receiving slightly higher
Medicare payments, more than 4,000 hospitals have established electronic systems for reporting specific quality-of-care measures.
Several pilot programs will offer physicians incentives to use electronic health records to meet quality goals.
CMS is working hard to meet a 2009 deadline for implementing an electronic prescribing system. The agency has published a
proposed rule for establishing basic e-prescribing standards, which it hopes to finalize by this fall. CMS also plans to launch
several e-prescribing pilot projects in January 2006.
PDP prescribing and payment data will mesh with a critical Medicare Coordination of Benefits information system that will
track drug purchasing information at point of sale. This will enable pharmacists and payers to determine eligibility, coverage,
and out-of-pocket costs when an elderly patient comes into a pharmacy. In tracking each beneficiary's true out-of-pocket spending
and coordinating payments with states and employers offering supplemental coverage, the system will create a complete but
confidential claims history for every senior. PDP claims data, electronic prescribing information, quality reporting initiatives,
and beneficiary hospital and medical records together will produce much richer and more extensive information on drug utilization,
efficacy, safety, and costs. The challenge for pharma marketers is to use this data to document the value of many important
therapies, and to recognize the limitations inherent in some products.
Jill Wechsler is Pharmaceutical Executive's Washington correspondent.