Lightning up device payments
Providers, devicemakers in holding pattern on compliance efforts as they await final rules for the federal Sunshine Act
Although many providers and drug companies have frozen their compliance with a new federal payment reporting law until regulations are finalized, many devicemakers are busy preparing. The Physician Payments Sunshine Act, part of the Patient Protection and Affordable Care Act, will require the CMS to annually publish online the payments and “transfers of value” made to physicians and teaching hospitals by group purchasing organizations and drug, device, biologic and medicalsupply manufacturers.
Federal officials are far behind the implementation timeline outlined in the law. The legislation required companies to begin reporting to the CMS by March 31, 2012, but a proposed rule was not published until Dec. 19, 2011. Federal officials wrote in the proposed rule that they now are aiming to issue a final rule before the end of 2012 and launch the program by March 2013 (See chart).
The delay has had relatively little impact on many providers and healthcare companies so far because they see the issue as too complex to take action until all of its many details are finalized and analyzed.
“We’re definitely working with the companies and trying to figure out what each needs to do, but we’re not going to have really good answers until we see the final rule,” says Kate Connors, a spokeswoman for the Pharmaceutical Research and Manufacturers of America.
In addition to uncertainty over the content of the final requirements, some provider and health companies are hoping federal officials amend various components of the regulations that they view as outside of the scope of the law, overly burdensome or likely to confuse patients.
Some drug manufacturers have been reporting physician payments to various extents for years because they were either required to so by state laws or because they implemented so-called corporate integrity agreements, which often result from past regulatory inquiries and enforcement actions.
Such reporting provided the basis for extensively cited physician conflict tracking reports by Propublica in recent years.
Despite the experience of at least nine drug companies with gathering and reporting such information, the final rule will likely require changes and enhancements to that reporting. An indication of the complexity of the issues involved is seen in the 47 pages of comments that PHRMA submitted relating to the proposed rule.
“At first, some of them thought their experience was going to help them out; I don’t think it is going to because it is going to be a completely different process,” Connors says.
Providers are taking a similarly cautious approach.
Heather Pierce, senior director of science policy and regulatory counsel at the Association of American Medical Colleges, says her organization’s member institutions support the goals of the Sunshine Act, but they also are concerned that the proposed rule would allow only 45 days for providers to review company submissions about them.
“There’s quite a process that teaching hospitals and clinicians and the academic medical centers who have faculty who are physicians will need to go through in a very short