Today, ASA responded to CMS Acting Administrator Marilyn B. Tavenner regarding the proposed “sunshine” rule (CMS 5060-P). The proposed rule comes as a result of the Affordable Care Act, which requires drug and device manufacturers to report each gift or transfer of value to a physician over $10 in value, or $100 in total gifts per year given to a physician.
The letter states, “ASA supports transparency and accountability. We believe the public should have access to accurate information about manufacturers’ payments to physicians and that physicians should have a fair opportunity to dispute inaccurate reports.”
ASA offered suggestions for improvement to the proposed rule and is seeking some clarifications.
In the official response, ASA addressed concerns that CMS will not arbitrate disputes between manufacturers and physicians. In addition, we were pleased to see that CMS proposed that annual meetings would be an exception. However, ASA is seeking clarification regarding what gifts or transfers of value would fall within the purview of the proposed rule. Importantly, the letter also encourages CMS to ensure that physicians and manufacturers have adequate time to review and correct reported data, that physicians are properly notified regarding data that may be publicly reported and that CMS acknowledges the burden this proposed rule places on physicians.
The letter offers suggestions requiring third party survey companies acting on behalf of a manufacturer to alert the physician that any payments could be subject to reporting and provide them with enough information for the physician to keep a record of the survey transaction. The letter also suggests that CMS distinguish between payments made for Continuing Medical Education (CME) and FDA regulated medical education. Finally, the letter requests that educational materials such as textbooks be interpreted as directly benefiting patients and excluded from any reporting.
ASA will continue to monitor this issue going forward and provide more information on how this rule will impact anesthesiologists as CMS develops the final rule.
ASA’s letter can be viewed here.
The CMS proposed rule can be viewed here.