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CMS accepting comment on Physician Payment Sunshine Act until Friday
The CMS has delayed the deadline for drug, device and biological companies to report payments to physicians and teaching hospitals under the Physician Payment Sunshine Act.
A proposed rule was issued in December. The reporting deadline was deferred from Jan. 1 to a date to be announced when a final rule is issued later this year.
The CMS will accept comments on the preliminary rule until 5 p.m. EST on Friday. The Physician Payment Sunshine Act requires manufacturers of drugs, devices and biologics covered by Medicare, Medicaid or the Children’s Health Insurance Program to annually report payments made to physicians and teaching hospitals to the Secretary of Health and Human Services.
Additionally, manufacturers and group purchasing organizations (GPOs) must report physician ownership or investment interests that apply.
The rule applies to payments and transfers of value, including gifts, food, travel, entertainment, consulting fees and honoraria valued at more than $10 each or $100 cumulatively per year. Product samples and educational materials intended for patient use are not subject to the reporting requirements, according to the rule.
Applicable manufacturers and GPOs are subject to civil monetary penalties for failing to meet the reporting requirements, according to the proposed rule published in the Federal Register.
Under the proposed rule, manufacturers would be required to submit a report by March 31, 2013. CMS would aggregate, collate and correct submitted data and make it publicly available on Sept. 30, 2013. Manufacturers would subsequently be required to report applicable payments on the 90th day of each calendar year.
Comments may be submitted electronically at www.regulations.gov or sent to the CMS, Department of Health and Human Services, Attention: CMS-5060-P, PO Box 8013, Baltimore, MD 21244-8013.
The reporting requirement is mandated by the Patient Protection and Affordable Care Act, the federal health care reform bill enacted in March 2010.
The proposed rule summary is available at: www.federalregister.gov/articles/2011/12/19/2011-32244/medicare-medicaid-childrens-health-insurance-programs-transparency-reports-and-reporting-of.
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All academic faculty, especially researchers, would applaud any mechanism that would remove fraud, dishonest use of relationships for capital gain or conflicts of interest that harm patients or abuse the trust of the physician-patient relationship and could compromise the future of biomedical research. The challenge is not to build silos around the scientists that work for industry or prevent the sharing of scientific thought, ideas and discovery with researchers in academics. So, in a society with 24/7 media coverage, trials in the media resulting in the perception of guilt (which is guilt by some standards today, even if exonerated) and news reporters as the judge and jury, how do we preserve the best of collaborative clinical research while maintaining the public trust? My great hope was that the government and leaders from all aspects of biomedical research would set clear categories, guidelines and delineate improper behavior or influence from the ability to collaborate and advance science and medicine.
The delay in the Sunshine Act still allows for rational thought and a clear plan for capturing these goals. I hope that what we finally see is a program that will accomplish what we need while eliminating (or reducing, I am not sure that dishonesty and greed will ever be conquered) what we do not want or need.
Richard F. Jacobs, MD
Infectious Diseases in Children Chief Medical Editor
Disclosure: Dr. Jacobs reports no relevant financial disclosures.
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