Let’s get some real issues on the table in the health reform debate—like Medicare’s clinical trial policy.  The Medicare program is not only the key to current and future health care delivery in this nation but also the most critical link to all clinical research occurring throughout the nation. 

Good science—and new cures and treatments for a host of diseases and illnesses–require that Medicare beneficiaries participate in clinical trials.  That was the vision and purpose of the clinical trial policy, laid out in an executive memorandum signed by President Clinton in 2000.  The goal was to provide increased access for Medicare beneficiaries to clinical trials—and that is not happening. During the Bush Administration, the policy was not fulfilling its intent and, in fact, was quite dismantled, creating a situation that discouraged participation of seniors in trials.

It’s not only seniors. The President had better check his health plan because many of the government plans do not cover clinical trials—as they should. 

Health and Human Services Secretary Sebelius should be spending more time addressing this issue.  She can provide the leadership to reform Medicare’s clinical trial policy, which currently:

• Compromises the quality and credibility of many research studies by discouraging enrollment of elderly patients
• Limits coverage for the elderly to potentially life-saving therapies and treatments
• Undermines the financial viability of the nation’s academic health centers where the majority of clinical trials take place
• Increases the likelihood of an adverse impact on the nation’s economy and job market as clinical trials continue to move overseas.

The Association of Academic Health Centers (AAHC) has been at the forefront in calling for reform of the policy.  One of AAHC’s most important recommendations is for the HHS Secretary to establish the position of research coordinator at the Centers for Medicare & Medicaid Services (CMS) to oversee clinical research coverage policy.  This position would ensure that an expert with knowledge of clinical research and trials processes and operations is providing needed leadership and making the issue a national priority.

President Obama and Secretary Sebelius need to signal that they recognize the significance of Medicare’s clinical trial policy.  Appointing a permanent administrator for CMS would also be a good start.  If the Administration can’t address clinical  trial policy, there are  many on Capitol Hill who will check their health plans, suddenly wake up and take notice, and address Medicare’s clinical trial policy so they can claim some real progress on health care reform.