by ecancer reporter Janet Fricker

The Physician Payment Sunshine Act (PPSA), better known as the ‘Sunshine Act’, came into effect in the US on August 1.

While its laudable goals are to provide greater transparency in relationships between the health care industry and physicians, concerns are being raised that disclosure of such relationships could hamper the future of education and medical innovation.

The legislation came after Senators Chuck Grassley of Iowa and Herb Kohl of Wisconsin exposed a number of questionable financial relationships between drug companies and doctors.

The Act was signed into law on March 23 2010, as part of the Patient Protection and Affordable Care Act (PPACA), which aimed to extend insurance coverage to some 32 million additional Americans through significant health care reform.

“Disclosure brings about accountability, and accountability will strengthen the credibility of medical research, the marketing of ideas and ultimately the practice of medicine,” said Grassley in a press release.
Further benefits, it is believed, include potentially lowering costs, and increasing rational use of drugs.
The Act requires manufacturers of drugs, devices, biological, or medical supplies covered by Medicare, Medicaid or the Children’s Health Insurance Program (CHIP) to report payments made to physicians and hospitals annually in an electronic format to the US Department of Health and Human Services (DHHS).

Mandatory categories to be reported include entertainment and gifts, food, travel, consulting fees, speaking fees, compensation for services, honoraria, certain research-related funding or grants, education or conference funding, physician ownership and investment interests, forms of equity, royalties or licenses and charitable contributions paid by industry.

Small transfers of value under $10, such as a $3 cup of coffee, are not required to be reported unless the aggregate total annual value exceeds $100 to a single physician in a given year.

The Act does not ban receipt, or set limits on items of value, it only places these transactions in the public domain on a website.

The mandate stipulates that all data collected from August2013 through December 3013 must be reported to CMS by March 31, 2014, with the agency set to publish the data on a public searchable website by September 30 2014.
For not reporting information penalties range up to $150,000 annually and $1 million for knowingly not reporting data.
Some think that continuing medical education (CME), where it is common practice for pharmaceutical and device manufacturing companies to fund or sponsor seminars for doctors to educate them about products, will prove an early casualty of the legislation.

Drug company sponsored CME events have been considered valuable in the education of physicians, with a recent Deloitte/Forbes survey finding that 57% of physicians considered industry-supported CME events as the best source for learning about new medications and treatments.

But concerns are being raised that physicians may in future feel less inclined to participate in these educational events due to the potential for a public back lash.
At a seminar sponsored by the Healthcare Leadership Council in March David Caraway,  from St Mary’s Regional Medical Center, Huntington, West Virginia, said ,“I have colleagues whose total transfer of value may be $250 a year, who told me they won’t do this anymore because they don’t want their name in some newspaper article. This is not an impactful financial incentive to that physician, but it’s a disincentive for innovation and for collaboration.”
There are further concerns that such disclosure could deter physicians from participating in pharma sponsored clinical trials, since revenue from these exchanges will also be recorded.

Speaking at the same seminar, Ryan Hohman, managing director of policy and public affairs at the advocacy group Friends of Cancer Research said, “Like it or not, successful innovation requires commercial entities to be involved, and successful education of physicians will require all experts to be educating each other.”

While the Sunshine Act is applicable only in the US, questions are being raised over whether companies subject to US regulation might now opt to globalise their domestic transparency systems.