February 5th, 2013

The Sun Is About to Shine

When the Patient Protection and Affordable Care Act was passed in 2010, the rules required to implement Section 6002, better known as the Physician Payment Sunshine Act (PPSA), were expected to be in place by 2011. But the sun was slow to shine and we waited until the first day of February 2013 for the Centers for Medicare and Medicaid Services (CMS) to release their final rules.

The Sunshine Act has great relevance to all CardioExchange members, as it requires all pharmaceutical, medical device, and biologic companies to report gifts and payments made to physicians and hospitals in the U.S., otherwise known as transfers of value, to the U.S. Secretary of Health and Human Services.

“Transparency” reporting is expected to begin in August 2013, with all payments being made publicly available in a searchable, sortable, downloadable website by 2014. The following information will be publicly reported:

  • Name, address, and other identifiers (e.g., NPI number or state license number) of who received the payment (or other transfer of value)
  • Amount and form of the payment (e.g., honorarium, reimbursement for travel)
  • Explanation of the payment’s purpose (CMS provides 16 potential categories, including consulting, education, and meals)
  • Product(s) associated with the payment (e.g., honorarium to attend an educational event discussing drug X)

There are some notable exceptions to transparency reporting. For instance, payments made for research are reported using special rules. In addition, unless a physician receives $100 or more annually from a company, individual payments less than $10 are exempted. And most controversially, payments related to ACCME-accredited educational event speaking where a medical product company supports the event but does not choose the speaker or pay them directly are not required to be reported.

To be clear, the responsibility to report these payments falls on the companies, not individual physicians. However, physicians and hospitals have the opportunity to dispute reported payments (although dispute does not prevent reporting). In addition, any penalties for not reporting are exacted on the companies (although penalties are currently limited to $1.15M per company per year, raising questions about compliance). But given the increased public scrutiny of industry payments to physicians, we should all be ready for more sun to shine on us.

Importantly, the legislation requires public disclosure, but does not limit these financial relationships. The logic behind the legislation is that by shining the light on the extensive and complicated financial relationships that exist between physicians, hospitals, and the medical products industries (pharmaceutical, medical device, and biologic companies), those relationships that may not be considered ethical or appropriate, such as receiving payments to listen to marketing presentations or for enrolling patients in clinical research studies when no rigorous research is taking place, will become less common with greater public scrutiny.

However, physicians, hospitals, and industry worry that those completely ethical and appropriate relationships, such as collaborating to conduct clinical research, will be similarly scrutinized and inhibited.

I think we gain the public’s trust by being open and transparent about the work we do in collaboration with industry. And individuals should be paid appropriately for their time.

But what do others think? Do you think this legislation will curb inappropriate payments or just add to the scandals our profession has weathered in the last few years? Will the Sunshine Act help to prevent those relationships that nearly all of us would frown upon or will it limit good science?

2 Responses to “The Sun Is About to Shine”

  1. Just my extremely personal opinion- I think the boat has sailed on gaining then public’s trust as a profession.

  2. William DeMedio, MD says:

    I feel that public reporting of serious potential conflicts of interest e.g. large payments for consulting and promoting a product in excess of $1000 is very important. Setting the threshold at $10 is very unwise. It will only “dilute” the water making it harder for the public to find the “big players”.