Groups Urge Feds to Issue Physician Payments Final Rule

Groups and coalitions representing physicians, labor unions, and distributors are expressing frustration that little progress has been made on a final rule outlining full disclosure procedures for medical device manufacturers and pharmaceutical companies.

The Centers for Medicare & Medicaid Services set a deadline of October 2011.

"We are now 15 months passed the statutory deadline for this vital regulation," said Curtis Rooney, president of the Healthcare Supply Chain Association in a media  statement last week. "The sooner the healthcare supply chain realizes full implementation of the Physician Payments Sunshine Act the sooner patients will realize the full benefits."

A Jan. 14 letter sent by the AFL-CIO and 18 other groups to the federal Office of Management and Budget expressed similar concerns and requested a quick release of a final rule.

"There is a significant consequence for healthcare system costs associated with the ongoing delay in implementation because of the practice by some physicians of over-prescribing certain drugs or by prescribing otherwise medically unnecessary and expensive treatments," the letter stated.

Under the original timeline, a final rule was scheduled to be issued by October 2011, with drug and medical device manufacturers submitting their physician payment information starting March 2013. After the 2011 deadline passed, the CMS said it would issue a final rule by the end of 2012.

The Physician Payment Sunshine Act will require manufacturers of medical devices and prescription drugs covered by Medicare and Medicaid to report all grants, consulting fees, and travel reimbursements they provide to physicians and teaching hospitals.

Under the proposed rule, companies would receive a $150,000 fine for not reporting any gifts or payments totaling more than $10. Information on those payments would be posted on a public website where affected companies and individuals would be able to review the data before it is made public. Information found to be inaccurate could be contested and corrected.

Charles Rosen, MD, co-founder of the Association for Medical Ethics, said the PPSA is designed to "rein in undue and harmful influence of money on medicine." Olsen and four other physicians sent a Jan. 15 letter to White House Chief of Staff Jacob Lew requesting that "the administration implement the PPSA without any further delay." The letter also suggested that "the final rules are being held up at the White House Office of Management and Budget."

The Sunshine Act has run into some opposition. Some organizations and manufacturers have raised issues ranging from the $10 threshold for reporting payments to suggestions that the proposed payment reporting process is too complex and could discourage physicians and hospitals from participating in research projects.

In a statement delivered at a September 2012 Senate hearing to consider implementation of the PPSA, the Association of Clinical Research Organizations (ACRO) outlined several concerns about its potential impact. They included confusion about how payments and transfers of value to physicians and hospitals will be reported and concerns that data provided to the CMS "has great potential to be misrepresented."

"In brief, ACRO believes the CMS would do best to 'go back to the drawing board' in its proposals for the tracking of research-related payments and transfers of value," the ACRO stated. "Because of the confusing and highly complex reporting requirements proposed - and resulting inability for us to comment constructively on an understandable and tangible proposal - we strongly urge CMS to issue a second proposed rule for comment before moving to finalize a regulation to implement The Act."

Rosen said the delay in issuing a final rule could be due to manufacturers who oppose some elements of the PPSA working behind the scenes. "Obviously, it's speculation but I can't think of who else would have suddenly developed opposition to it other than those who already were [opposed to the PPSA]," Rosen said.

Other healthcare officials say the long delay in issuing a final rule could be the product of the federal government being overwhelmed with implementing multiple provisions of the Affordable Care Act, particularly after many were put on the back burner until after the November 2012 elections.

"I think it has more to do with the fact that the federal government is overwhelmed with its workload and having trouble getting things done," said Blair Childs, senior VP of communications for Premier Healthcare Alliance. "Right now, their priority appears to be implementing payment and delivery system reform."

As for opponents working to delay or weaken the PPSA, Childs said he doubts it. "Some small manufacturers were opposed to it but, overall, there's been relatively little opposition to the PPSA," said Childs.