The AAFP has responded to CMS' proposed rule(www.federalregister.gov) for implementing certain transparency provisions within the Patient Protection and Affordable Care Act(frwebgate.access.gpo.gov), offering recommendations to improve the agency's final rule.
Under the proposed regulation, any gift or payment of more than $10 to physicians from a pharmaceutical or medical device industry member will be reported to HHS, which, in turn, will publish online, physician-specific aggregate reports containing that information annually.
In a Feb. 8 letter(5 page PDF) to CMS Acting Administrator Marilyn Tavenner, AAFP Board Chair Roland Goertz, M.D., M.B.A., of Waco, Texas, said that although the AAFP supports and values the transparency provisions, the Academy is concerned that the proposed rule, as written, could be inordinately costly.
According to Goertz, "The proposed reporting requirements create significant complexities, such that CMS estimates it will cost health care companies and health care providers $224 million in the first year and over $163 million annually thereafter to comply."
Moreover, added Goertz, the Academy is particularly concerned about CMS language regarding indirect transfers of value, and he urged CMS to specify in the final rule that only direct transfers of value constitute reportable events.
"Since the AAFP was involved in legislative negotiations that ultimately resulted in the Affordable Care Act, we are aware that previous versions of the underlying bill included language that considered indirect payments a reportable event," he said. "However, since the statute was intentionally finalized to specify that indirect transfers of value are not reportable events, the AAFP believes that CMS does not have the authority to expand beyond the scope of the law and propose policies that require in any circumstance that an indirect transfer of value be reported."
- AAFP Board Chair Roland Goertz, M.D., M.B.A., sent a comment letter to CMS in response to the agency's proposed "Sunshine" regulation.
- Goertz said the Academy is particularly concerned about language in the proposed rule that pertains to indirect transfers of value.
- CMS has indicated that manufacturers may be required to submit partial-year data on March 31, 2013, depending on the timing of the final rule.
Other AAFP recommendations include
- establishing a uniform, national and mandatory data verification and arbitration process, structured so that physicians do not incur legal fees when defending themselves from erroneous manufacturer reporting;
- clarifying that speaker fees for accredited and certified CME programs should not be considered reportable events;
- offering supplementary examples of both reportable and nonreportable events that can occur when an applicable entity's representative meets with a medical practice;
- specifying that reporting requirements apply only to physicians who personally decide to accept transfers of value, such as group meals, from applicable entities;
- working with physician organizations to strengthen and lengthen the review process;
- specifying that reporting requirements do not apply to clinical research when funds paid to an academic institution are then "indirectly made to the researcher" and that approved clinical research that is subject to "human subjects (institutional review board) review" also is excluded; and
- making the reporting information CMS proposes to publish on a consumer website available for public comment first to ensure the data are useful and unbiased.
Goertz also said in the letter that CMS' proposed 45-day review period for physicians and other covered entities to contest any data with which they do not agree is a matter of some concern.
"For such a new and complicated program, that time frame is simply too brief for a practicing physician to access, review and then potentially appeal a detailed financial document," he noted. "The AAFP finds it unreasonable to suggest that practices must habitually find and check various CMS websites or electronic newsletters for updates on their transparency reports. Placing this unnecessary responsibility onto the practice will consume a tremendous amount of valuable time and resources that should be spent on patient care."
After publication of CMS' procedures to implement the reporting provisions -- originally scheduled for Oct. 1, 2011 -- was delayed until mid-December, CMS said(www.cms.gov) it was proposing that manufacturers and group purchasing organizations (GPOs) be required to submit partial-year data on March 31, 2013, depending on the timing of the final rule. Overall, the agency has estimated that about 150 drug and biologic manufacturers, 1,000 device and medical supply manufacturers, and 420 GPOs will be required to submit information each year.
Following data submission, CMS said it then would "aggregate manufacturer submissions at the individual physician and teaching hospital level, provide them with a 45-day period to confidentially review and, if necessary, correct the data, and make the data publicly available by Sept. 30, 2013."
CMS is accepting comments on the proposed regulation until Feb. 17 and expects to publish a final rule before the end of the year.