Health System Reform Insight - Feb. 24, 2012
Given the new direction for the nation's health system, the AMA has developed Health System Reform Insight to help you understand what this new direction means to you and your patients.
A proposed rule by the Centers for Medicare & Medicaid Services (CMS) outlines a regulatory process for public reports that detail physicians' financial interactions with drug and medical device manufacturers. However, the proposed rule would make it difficult for physicians to protect themselves against inaccurate or misleading information. The AMA is advocating for built-in physician protections in the final rule.
Once the final rule is published later this year, manufacturers that participate in federal health care programs must track any payments and gifts of $10 or more to physicians and teaching hospitals, as required by the Affordable Care Act (ACA). Manufacturers must submit annual reports of aggregate payments that exceed $100 to the U.S. Department of Health and Human Services, which will publish the majority of the information on a searchable public website in 2013.
Among the categories of payment identified in the ACA are consulting fees, grants, research, honoraria and charitable contributions. The ACA also requires reporting of interests held by physicians and their immediate family members in manufacturers and group purchasing organizations (GPOs), excluding publicly traded security and mutual funds.
While only manufacturers and GPOs that fail to submit timely and accurate transparency reports are subject to monetary penalties, the careers and professional reputations of physicians could be at risk if misleading or inaccurate reports are published.
Key changes the AMA is requesting
In light of the potential harm to physicians, the AMA submitted a comment letter co-signed by 49 medical specialty societies and 43 state medical associations, explaining concerns about five important aspects of the proposed rule:
- Accuracy of reports. CMS's proposed rule is unlikely to ensure accurate reports because it severely limits physicians' ability to review and challenge reports. The AMA is requesting a standardized reporting process that gives physicians sufficient opportunity to correct false, misleading or inaccurate reports.
- Indirect payments. Although Congress limited reporting to direct physician payments, the proposed rule expands the reporting requirements to include a broad category of indirect payments that are not specified in the ACA. The AMA is advocating to restrict reporting of payments to third parties to those made at the request of the physician or designated on the physician's behalf.
- Certified CME. Despite Congress' intentional exclusion of certified continuing medical education (CME) funding as a reporting requirement, the proposed rule requires manufacturers to report certified and accredited CME funding. Urging CMS to withdraw this requirement, the AMA letter explained that certified CME does not allow manufacturers to control or provide input on the content, speakers or attendees of CME activities.
The AMA also joined other national organizations involved in CME in submitting a separate letter that further advocates for the exclusion of CME from the transparency reports.
- Accurate attribution. The proposed rule would attribute payment to a physician based on employment, affiliation or association with an entity or person that received a direct payment. This reporting requirement would apply even if the physician did not directly—or in some cases, indirectly—benefit from that financial interaction. The AMA is encouraging CMS to require manufacturers only to report direct payments and indirect payments made at the physician's request or on the physician's behalf.
- Significant paperwork burden for physicians. The process outlined in the proposed rule imposes ongoing and time-intensive paperwork obligations on physicians if they are to ensure that the reports accurately reflect their financial interactions. The AMA estimates that maintaining ongoing records of every activity and reviewing reports would take more than 80 hours of a physician's time each year. The AMA is asking CMS to reduce this burden by requiring manufacturers to provide ongoing notification and a cumulative report to physicians prior to submitting the annual report.
The AMA will publish additional information and provide a toolkit to help physicians evaluate their reports when the final rule is issued.
While the deadline to comply with the Health Insurance Portability and Accountability Act version 5010 electronic transactions was Jan. 1, the agency extended the enforcement date by 90 days. Visit the AMA's version 5010 Web page to access resources to help your practice comply by March 31.