As months and months go by, the Centers for Medicare & Medicaid Services has continually delayed issuing a final rule for gathering and publishing data containing financial ties between physicians and drug and device makers. Three months ago, the agency again postponed the unveiling without offering a firm deadline. And so, industry trade groups are getting more than a little impatient and have dashed off a polite, but antsy letter asking CMS to get moving already.
Originally, drug and device makers and group purchasing organizations were to start collecting data this past January, but that was postponed to January 2013 (back story). The data includes all ownership or investment interests held by a doctor or family member, and that info must also be disclosed. Industry is concerned there will not be enough time to implement the rule. Penalties for violations can range from $1,000 to $100,000.
“As we approach 2013, we ask that when CMS completes its thorough review of all stakeholder comments and releases a final regulation, that CMS grant our companies sufficient preparation time to implement the final rule,” the trade groups writes. “To properly implement the data collection and reporting required by the Sunshine provisions, our companies will need this time for system development, implementation, testing, and training.”
The rule, by the way, is the centerpiece of the Physician Payments Sunshine Provision of the Patient Protection and Affordable Care Act, which was passed after years of controversy and scandal in which various government probes found undisclosed financial conflicts between physicians, academic researchers and industry. The issue raised was that such conflicts may unduly influence medical research and practice.
“Congress has done its work by passing this law and we are committed to its successful implementation. A key element of success is sufficient time to properly implement all elements of the law,” the trade groups write. “We stand ready to implement the final rule upon its publication. We think it’s important for your agency to act in a timely manner and to permit sufficient time for the companies we represent to effectively meet their data collection obligations” (here is the letter).
The letter was sent by PhRMA, the Advanced Medical Technology Association, the Biotechnology Industry Organization and the Medical Imaging & Technology Alliance to Marilyn Tavenner, the acting CMS Administrator. We asked the CMS for a comment and will update you accordingly.
From Pharmalot, by Ed Silverman, August 17, 2012