Inexcusable federal foot-dragging is delaying the rollout of the Physician Payments Sunshine Act -- a landmark law outing doctors' often lucrative financial ties to industry.
Less than three months before drug and medical device manufacturers are slated to start complying with the law, it's become clear that the Centers for Medicare & Medicaid Services (CMS) has not made this important accountability measure an agency priority. CMS is charged with writing the rules and regulations that translate the law's language into practical guidelines. The agency is woefully behind.
CMS blew past an Oct. 1 deadline for drafting the regulations, according to an Oct. 3 letter signed by two of the Sunshine Act's champions -- Sen. Chuck Grassley, R-Iowa, and Sen. Herb Kohl, D-Wis. When CMS might complete this important task is unclear.
The agency is unwilling to say when it will issue the guidelines and has often delayed responding to the senators' inquiries about its progress. CMS officials also declined to set a date during an interview with an editorial writer this week, providing this statement instead:
"CMS is delaying the issuance of regulations to allow us sufficient time to determine the most efficient and cost-effective way to implement the Sunshine provision. We are working to identify whether the provision can be supported by existing resources, in order to ensure that millions of taxpayer dollars aren't wasted in developing duplicative infrastructures."
While that's an admirable goal, surely it could have been accomplished in the 19 months since the Sunshine Act's passage. The law, which languished as a standalone bill for several years, was tucked into the 2010 federal health reform law, the Affordable Care Act.
Some might be tempted to applaud the delay of any new industry regulations. That's shortsighted. The Sunshine Act will require public disclosure of the large sums sometimes paid to medical professionals by industry. That collaboration is important for medical innovation, but there are also concerns about whether money influences doctors when it comes time to choose between new products and older drugs or devices. Payment information should be easily accessible so that patients can weigh for themselves if medical providers have their best interests at heart.
The Sunshine Act garnered support from a bipartisan array of politicians and from many medical industry leaders. In June 2010, former Medtronic CEO William Hawkins wrote a commentary for the Star Tribune opinion pages, saying that the measure struck a balance between preserving collaboration while "providing long-overdue transparency to these relationships.''
Minnesota, as a medical device industry epicenter, has a critical interest in making sure this law rolls out smoothly for industry. Companies are expected to begin tracking the provider payment information on Jan. 1, with payment details to become public in 2013. The regulations should have been drafted by now.
While the agency said it will be flexible in enforcing the law, the delay is frustrating. "Our member companies need lead time to put in place the business processes to comply with the law, and the regulations are critical in doing so,'' said a spokeswoman for AdvaMed, a device industry trade group. Some companies are voluntarily making this information public ahead of time.
To be fair, federal officials charged with drafting rules and regulations for the Affordable Care Act deserve some sympathy. This is a monumental undertaking during an era of shrinking resources. Still, the Sunshine Act is a high-profile part of that law and one that should be straightforward and relatively inexpensive to implement. The disturbing lack of progress doesn't bode well for federal officials' ability to meet other critical health reform deadlines.