Clarification Sought on CMS' Proposed Clinical Research Policy

Clarification Sought on CMS' Proposed Clinical Research Policy

WASHINGTON – In an August 10 letter to the Centers for Medicare and Medicaid Services, Elizabeth Spurgin, a Vice President at B&D Consulting, urged further clarification of the distinction between the CMS' proposed Clinical Research Policy and the existing regulations governing Medicare coverage of investigational devices used in clinical research.

"While we appreciate CMS's desire to clarify the policies related to eligible trials, we remain concerned that the proposed policy will not go far enough," said Spurgin. "In our experience, regional contractor medical directors who have responsibility for applying the national coverage policy interpret it in different ways, resulting in uneven access to investigational care for Medicare beneficiaries. Further guidance from CMS to its contractors would eliminate the confusion."

Spurgin's comments were submitted to CMS as part of a stakeholder open comment period. A final National Coverage Determination is expected October 17, 2007.

B&D Consulting's health and life sciences practice group offers advisory and advocacy services to health care providers, pharmaceutical companies, medical device manufacturers, industry groups and voluntary health associations. The group provides strategic reimbursement consulting and tactical reimbursement support.

As part of its practice, B&D Consulting works with industry sponsors of clinical trials to seek coverage and reimbursement from public and private payers for the investigational use of their products. To learn more about these services, contact Liz Spurgin at [email protected].