Sometimes, a little Congressional pressure may work. After weeks of delay, the Centers for Medicare & Medicaid Services and the US Department of Health & Human Services have finally released guidelines on how drug and device makers are supposed to submit information on payments to physicians, and how that info would be made publicly available.

The guidelines were required by the Physician Payments Sunshine Provision of the Patient Protection and Affordable Care Act, and were due this past October 1. But the agencies blew past the deadline without offering much explanation or a hint as to when guidelines would become available, prompting criticism from BIO, PhRMA, Consumers Union, AdvaMed, Community Catalyst and Pew Health Group, among others.

They were concerned that delays in establishing procedures for the submission and public reporting of required info will make it difficult for manufacturers to know whether they are meeting their legal obligations (back story). And they found sympathetic ears in two US Senators - Iowa Republican Chuck Grassley and Wisconsin Democrat Herb Kohl - who had scheduled a hearing today.

A key bone of contention - originally, manufacturers and group purchasing organizations were to start collecting payment data beginning January 1, 2012. This includes all ownership or investment interests held by a doctor or family member, and that info must be disclosed as well. Details must be made public by September 30, 2013, and penalties for violations can range from $1,000 to $100,000.

But the January 1 deadline has been extended until after a final rule is published, and it is not clear when that will take place. Under the circumstances, the hearing was scrapped. “The completion of the guidance is good news,” Grassley says in a statment. “It came after a lot of follow-up…to find out the status and to press for results from CMS. It shows Congress has a responsibility not just to make laws but also to see that they’re carried out as intended. Companies need this guidance to do their part.”

[UPDATE: While supportive of the overall effort, one group did express concern with some provisions. Marcia Hams of Community Catalyst, says the draft does not provide mandatory, and clear definitions of categories - such as education, research and consulting - that could open the door to varying interpretations by each company. "This would make the data inconsistent and confusing," she says in a statement.]

For the record, the Sunshine Act requires drug and device makers to report all payments to physicians - such as consulting fees, honoraria, travel, speaking gigs, entertainment and other goodies - to the HHS, which must then publicly disclose the identity of the drug or device makers, physicians and the drug or device associated with the payment.

The requirement came about after a long-running Senate probe, which was spearheaded by Kohl and Grassley, into undisclosed conflicts of interest among physicians and the pharmaceutical and device industries. At issue are concerns that financial ties may unduly influence both medical research and any subsequent medical practice. The law, however, has also generated some bitterness among physicians who say payments do not sway their judgment.

What does the guidance say? You can read it here.

Doc pic thx to Jerome Kassirer