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CMS accepting comment on Physician Payment Sunshine Act until Friday
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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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The Sunshine Provision (also known as the Sunshine Act) implicates that starting January 1, 2012, any US drug or device manufacturer that provides compensation to a physician or medical institution for any kind of services rendered will have to report it to the government. The reporting benchmark is any amount over $10 for any single event or $100 cumulative in one year. Manufacturers would subsequently be required to report applicable payments on the 90th day of each calendar year.
There are close to one million physicians in the United States and hundreds of companies to which the rule will apply. Even if less than 20% of all physicians had some level of interaction with some of the companies that are targeted, this will mean tens of millions of interactions accumulating over the years. It is unclear where the cost for collecting, capturing, monitoring, analyzing, and reporting all this information will come from. Is it going to be the taxpayer or the limited healthcare dollars? It also remains unclear what purpose this database will serve.
I personally think that transparency in the form of disclosure is very important in any business that involves the trust of the public and this includes the business of healthcare. My concern is that certain doctors will be vilified or scapegoated through “guilt by association.” For example, in recent times and on multiple occasions, media outlets (including popular websites) looking for sensationalism, have acted as prosecutor, judge and jury at the same time, towards some physicians who were paid “big dollars” by pharma, without a single evidence of maleficence. At any level, most interactions with industry do not necessarily equate to inappropriateness. Although certain inappropriate behaviors have been noted in the last few years, they remain isolated and extremely rare. It is unclear whether the proposed act will help weed out the rare “bad apples.”
In many ways, transparency is welcome and should be encouraged as long as it is done responsibly without malintent. After all, healthy interactions between healthcare providers (including physicians, nurses and hospitals) and pharmaceutical industry are a positive contribution to healthcare quality, and frankly should be encouraged in the right context. I do hope that for the sake of consistency, the Sunshine act can expand and spread its “rays” to include amongst others, political contributions to any serving official at any level regardless of the source starting at $1.
Tanios S. Bekaii-Saab, MD
HemOnc Today Editorial Board member
Disclosure: Dr. Bekaii-Saab reported no relevant financial disclosures.
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While it is important that contacts between industry and health care providers are as transparent as possible, I worry that compliance with this new requirement will be very burdensome both on pharma and on the individual provider.
Additionally, and perhaps far more importantly, this requirement does not address the other multiple sources of conflict of interest that exist in health care (such as grant funding, need for promotion and tenure, or links to various political and advocacy organizations). Examination of the most serious scandals in health care over the past 20 years reveals that it was these latter conflicts, not industry payments, that dominate. While financial transparency is important, we need to be sure we address these latter conflicts as well.
Adam M. Brufsky, MD, PhD
HemOnc Today Editorial Board member
Disclosure: Dr. Brufsky reported no relevant financial disclosures.
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