"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.