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CMS accepting comment on Physician Payment Sunshine Act until Feb. 17
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The Centers for Medicare and Medicaid Services 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 2011. The reporting deadline was deferred from Jan. 1 to a date to be announced when a final rule is issued later this year.
CMS will accept comments on the preliminary rule until Feb. 17 at 5 p.m. Eastern Standard Time.
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 http://www.regulations.gov or sent to the Centers for Medicare and Medicaid Services, Department of Health and Human Services, Attention: CMS-5060-P, P.O. 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 https://www.federalregister.gov/articles/2011/12/19/2011-32244/medicare-medicaid-childrens-health-insurance-programs-transparency-reports-and-reporting-of.
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The Sunshine Act will undoubtedly create a significant amount of work for device manufacturers, drug companies and group purchasing organizations (GPOs), who are required to gather and report considerable data. Its impact on physicians is likely to be much less significant. Patients will have access to more data about payments you and your immediate family members receive from drug or device companies. However, even for the handful of patients who bother to review the data, the most likely result will be a conversation in which you can explain why you have a relationship with the company.
The Sunshine Act does not create any new penalties that apply to physicians. Its penalties are aimed at manufactures and GPOs who fail to report required data about payments to physicians and teaching hospitals. Of course, a variety of state and federal laws already apply to these payments. The Sunshine Act certainly may bring additional governmental scrutiny to some of these payments, but given the current level of attention, any increase might be difficult to notice. To the extent you have any financial relationship with a health care-related company, you will want to be sure that the relationship has been reviewed by counsel familiar with health care law. However, if you are considering using your time to comment on proposed rules, I would encourage you to focus on another proposed rule that will be coming out in the Federal Register in the coming weeks. That rule, issued on the CMS website on Valentine’s Day, may greatly increase the burden on physicians who discover they have received an overpayment. While the Sunshine Act will keep large companies busy, its direct impact on orthopedic surgeons is likely to be minimal.
— David M.Glaser, JD
Orthopedics Today Editorial Board Member
Minneapolis
Some hospital systems are now asking for disclosures of relationships with manufacturers in order to achieve transparency when a specific product is selected for usage in the hospital system. As long as the relationship is clear as to whether the physician receives royalties when he does a case within his hospital system, or if he is just a consultant or advisor to the company regarding a specific product, then the Sunshine Act shouldn’t be terribly burdensome. The problem arises when a physician develops a product, then influences the product choice within his hospital system and receives renumeration from the company in the form of a royalty payment when that product is used by the developing surgeon. Since the introduction of Advamed, this has rarely been a problem.
— Jack M. Bert, MD
Business of Orthopedics Section Editor, Orthopedics Today
Minneapolis