“The Sunshine Act will raise much more attention to various potential conflicts of interest within the healthcare arena,” said Dr. Daniel Carlat, director of the Pew Prescription Project, a not-for-profit organization that advocates for transparency in relationships between physicians and industry. “Because of that act, and because it's finally being implemented, we're hearing a lot more about issues of conflicts of interest.”
A study and a federal report, each published within the past month, were critical of conflict-of-interest policies that are in place for Medicaid and Medicare Part D drug formulary committees.
The analyses found less-than-rigorous oversight of conflicts among members of the pharmacy and therapeutics committees, which are panels responsible for deciding what drugs will be included on formularies. Both also noted that current policies may not protect against bias.
“Conflicts of interest jeopardize the integrity of professional judgment, compromise the quality of patient care and erode the public's trust in federal healthcare,” HHS' inspector general's office wrote in its report on Medicare pharmacy and therapeutics committees.
The federal watchdog went on to recommend that the CMS take steps to improve its oversight of pharmacy and therapeutics committees and set standards for sponsor oversight of committee conflicts of interest.
Sponsors are private insurers that contract with the CMS to administer drug coverage to the roughly 31 million Medicare beneficiaries who are currently enrolled in the Part D drug benefit.
The other study, which was conducted by pharmacists at the University of California at San Francisco, called for a model policy that could be adapted by drug selection committees in individual states. The authors found that some state policies weren't likely to protect drug decisions against industry influence.
“The absence of publicly available policies illustrates a lack of transparency about how (conflicts of interest) are managed,” the UCSF researchers concluded. “Improving public access to policies can increase transparency and public trust in the drug selection process.”
A task force convened by the Association of American Medical Colleges several years ago also called for disclosure of conflicts of interest on hospitals' pharmacy and therapeutic committees. The task force made a number of recommendations in three reports that were released in 2008 and 2010.
“Academic medical centers have been addressing conflicts of interest in a very robust, thorough way for some time,” said Heather Pierce, AAMC's senior director of science policy and regulatory counsel.
The American Medical Student Association introduced an annual bias scorecard in 2007. The score weighs factors included in the Sunshine Act rule, such as gifts and fees for consulting and speaking, as well as more specific conflicts, such as free samples and drug sales representatives' access to medical staff. Thirty academic medical centers received “A” marks on the most recent scorecard.
Some hospitals have gone so far as to ban sales representatives' access to staff or allow access only by appointment, Carlat said. He added that more physician faculty members are not only disclosing their financial relationships with manufacturers, they are establishing how comprehensive and public those disclosures need to be.
“It's an issue of what sort of disclosure is appropriate in hospitals and academic settings,” Carlat said.
