How will the Sunshine Act affect physician access?

When the Patient Protection and Affordable Care Act was passed in 2010, politicians and pundits from every corner of the country came out of the woodwork to speak their piece on the direction that so-called "Obamacare" would take the country's medical industry. While tangible reforms like the coverage portal have deserved their fair share of criticism for operational setbacks, very few are talking about a once-little known aspect of the ACA that is starting to make waves among physicians.

The Physician Payments Sunshine Act was initially passed as part of the ACA in 2010, but the law only came into effect at the end of September 2014. The bill mandated the creation of a full register of all payments made from pharmaceutical or medical device marketing companies to physicians for promotional speeches, travel arrangements, per diems and dozens of other criteria. The Sunshine Act is already starting to influence physician access for sales representatives, and as more data is added to the registry, pharma and medical device executives will want to keep a close eye on how public disclosure of physician payments affects the way patients view their products.

Combing through data
On Oct. 1, 2014, the U.S. Centers for Medicare and Medicaid Services launched the public-facing portion of its Open Payments website, which compiles and indexes all payments made to physicians from third parties. Because the site just went live, the registry only contains information from Aug. 1, 2013 to Dec. 31, 2013.

"We are taking a big step forward in shining the light on these financial arrangements," Shantanu Agrawal, M.D., deputy administrator for the CMS and director of the Center for Program Integrity, told the Chicago Tribune. "Using this new data, it is now possible to conduct a wide range of analysis of payments made by drug and device manufacturers that were never possible before."

The benefits for patients are immediately obvious. Instead of wondering whether they have been sold a product based on endorsement payments instead of medical evidence, patients are now able to research if their physicians have had financial encouragements from pharma or medical device companies. Ostensibly, the registry will allow patients to participate more actively in their care by researching the right treatments from trustworthy physicians.

Not as it seems
On the surface, a complete ledger of payment information between private organizations and doctor may seem like a blow to physician access for sales representatives, but the Open Payments registry may be riddled with so many errors that make it an unreliable financial record in the first place.

The Wall Street Journal compiled several examples of physicians and drug or device manufacturers that have incorrect payment data attributed to them. The WSJ explained one case where a data entry error caused $155,772 in travel expenses from a major pharmaceutical company to be mistakenly ascribed to a professor of neurology at Harvard Medical School. However, both the company and the physician claim that the real amount was less than $2,000. 

The CMS is well-aware of these errors. The Chicago Tribune explained that the agency has chosen not to list the identities of physicians behind roughly 40 percent of the raw data submitted by pharma and medical device companies. CMS officials explained that they cannot verify the identities of the physicians in these cases, so it is not listed on the Open Payments website.

A natural first reaction to this news would be to worry that patients will see incorrect payment information and base care decisions off of the mistaken data. However, ProPublica noted that the Open Payments database is such an organization nightmare that even the most tech-savvy patients will not be able to find specific information easily.

Whether it is due to data entry errors from pharma and medical device companies or development issues from the CMS, ProPublica explained that information in the registry is not consistently labeled. Payments from a single company are attributed to several shell corporations, while drugs are either vaguely specified or named in such detail that payments must be listed under each individual variant. Most of all, the database is not completely indexed so patients cannot search the entire database for a single name.

Some consumers may be taken in by the haphazardly constructed Open Payments database, but many will likely not have the energy to spend searching through the convoluted registry.

The impact on physician access
Over time, the CMS is expected to clean, format and index all payment information, and as successive reporting periods come and go, the Open Payments site will eventually become accurate and searchable. However, that does not have to mean the end of physician access for sales representatives from pharma and medical device companies.

In an interview with Becker's Spine Review, Sheeraz Qureshi, M.D., assistant professor of spinal surgery at New York City's Icahn School of Medicine at Mount Sinai Hospital, explained that not only is this paradigm unlikely to change, but collaboration between medical professionals and commercial manufacturers is a benefit, not a drawback.

"I do not believe the Sunshine Act will dissuade [physicians] from forming relationships with device companies," Qureshi said. "There are so many positives that come from surgeon-industry collaboration and we should view full disclosure as a way to highlight how this collaboration helps to advance the field of medicine and patient care."