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.