Drug Industry Daily

Drug Industry Groups Urge CMS to Release Long-Delayed Sunshine Rule, Grant Them 180 Days to Comply


Pharma trade groups are pressuring the Centers for Medicare & Medicaid Services (CMS) to release the nearly year-late Physician Payment Sunshine Act final rule immediately, but they urge the agency hold off on collecting data on drugmakers’ payments to physicians until 180 days after the rule comes out.

Companies need this time for system development, implementation, testing and training, PhRMA and the Biotechnology Industry Organization (BIO) said in a letter to the agency.

As of now, the CMS plans to begin requiring data on drug manufacturers’ and group purchasing organizations’ payments to doctors and hospitals in January 2013.

The CMS pushed back the start of data collection to January 2013 in May, saying it needed more time to address the more than 300 stakeholder comments on the December 2011 proposed rule before publishing the final version. At that time, the CMS said it would issue the final rule this year (DID, May 8).

If the agency released the rule today, a 180-day compliance window would mean data collection wouldn’t start until mid-February 2013. The trade associations originally requested the six-month period in comments on the proposed rule (DID, Feb. 22).

CMS was originally supposed to publish the final rule Oct. 1, 2011, and begin collecting drugmakers’ payment data in 2012 (DID, Dec. 16, 2011). However, the agency didn’t come close to meeting that deadline as it hadn’t even released the proposed rule by the October 2011 final rule deadline.

After the proposed rule came out, lawmakers pressed HHS and the CMS to publish the final rule this summer (DID, April 5).

The CMS has received the letter and is reviewing it, the agency told DID. It would not provide any update on the timing of the final rule.

The Sunshine Act, a provision of the 2010 Affordable Care Act, applies to manufacturers of drugs, biologics and medical supplies covered by Medicare, Medicaid or the Children’s Health Insurance Program.

View the letter at www.fdanews.com/ext/files/08-20-12-sunshine.pdf. — Sarah Karlin