U.S. Senator Lamar Alexander, senior Republican on the Senate health committee, has sent a letter to HHS Secretary Kathleen Sebelius, asking for clarity on her administration’s position on patient access to personal health information.  Alexander expressed his concern over conflicting actions: (1) CMS final rule allowing clinical laboratories to give complete test reports directly to patients; and (2) the FDA’s recent warning letter to 23andMe, a direct-to-consumer genetic testing laboratory, asking that the company stop marketing certain tests directly to consumers, due to the risk of misuse of test results.  Alexander states that the conflicting actions will slow down the access to or availability of novel diagnostics and targeted therapies.

The full text of Senator Alexander’s letter can be found here.