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Shadows of the Sunshine Act

A Sunshine Act in the past has encompassed statutes that mandate governmental agencies and departments to open meetings to the public. In this way, elected officials and government employees do their work in public or, as has been stated, “government in the sunshine.” The Freedom of Information Act falls under this category by requiring agencies to share information they have obtained with the public. Exceptions are permitted in the interest of national security or to safeguard the privacy of businesses. Now, it seems, that physicians who collaborate with medical manufacturers must now practice medicine in the sunshine without the safeguard of the privacy of a medical business.

The Physician Payments Sunshine Act (sponsored by Senators Charles Grassley, R-Iowa, and Herb Kohl, D-Wisconsin) was rolled into the Patient Protection and Affordable Care Act (Section 6002) and was supposed to go into effect on January 1, 2012. On November 27, 2012, the Sunshine Act was sent to the Office of Management and Budget (OMB) and should be implemented on or around February 26, 2013. The Sunshine Act requires manufacturers of drugs, medical devices, and biologicals that participate in U.S. federal healthcare programs to report payments and items of value given to physicians and teaching hospitals. Manufacturers will submit the annual reports to Centers for Medicare and Medicaid Services (CMS). There are 14 categories of payments or transfers of value. According to the CMS, each report must include the following information:

  1. Recipient’s name
  2. Recipient’s business address, specialty, National Provider Identifier number
  3. Amount of payment
  4. Date of payment
  5. Form and nature of payment, including
    • consulting fees
    • compensation for services other than consulting
    • honoraria
    • gift
    • entertainment
    • food
    • travel
    • education
    • research
    • charitable contribution
    • royalty or license
    • current or prospective ownership or investment interest
    • direct compensation for serving as faculty or as a speaker for a medical education program
    • grant

Items exempt from financial data collection are: CME education, samples, and patient educational materials.

After the collection of data on individual physicians and teaching hospitals, there will be a 45-day review period for physicians to contest inaccurate data through an online portal. The results will be available to the public online by September 30, 2013.

Shadows

The AMA has spearheaded a challenge to CMS concerning the division that will collect and distribute the public reports on physician-industry interaction. CMS has designated the Center for Program Integrity (CPI), its anti-fraud unit, as the collection and distribution arm of the Sunshine Act. The AMA suggested another division should be chosen because entrusting the CPI with this mission would essentially make it the ethical police of the medical profession.

From a legal perspective, the Sunshine Act has been heralded as “a new dawn of transparency, compliance obligations, and regulatory scrutiny,” which no other profession has had to undergo. A conscientious attorney, who preferred to be anonymous, suggested that physicians who continue to participate in speaker bureaus, lead clinical trials, or otherwise collaborate with manufacturers, need to understand “the risk of exposure the Sunshine Act presents and take prudent measures so they do not get burned.”

To express your opinion, contact CMS’ acting administrator, Marilyn Tarenner.

For further information, visit Physician Payment Sunshine Act.

 

Do you collaborate with a medical manufacturer?

What is your opinion of the Sunshine Act?

Do you plan on interacting with Pharma reps about new medications and/or samples?