Pressure Mounts on Medicare Agency to Issue Disclosure Guidelines

Font Size:

Members of Congress respond after CMS misses deadline in health care reform law.

Font Size:

After missing a statutory deadline, the federal agency responsible for administering Medicare and Medicaid says it is “working hard” to develop guidelines implementing key transparency provisions in the new health care law.  But two key members of Congress remain dissatisfied with the agency’s delay.

In addition to overhauling the nation’s system of health insurance, the Patient Protection and Affordable Care Act imposed a new obligation on pharmaceutical companies and medical device manufacturers to report to the government on payments they make to physicians.

The new reporting requirement, which takes effect January 2012 with public disclosure beginning in September 2013, aims to address mounting ethical concerns about apparent or actual conflicts of interest in medical decision making.

To provide the medical industry with clear instructions about how to prepare and submit the required disclosures, the Affordable Care Act called upon the federal Centers for Medicare and Medicaid Services (CMS) to release guidelines by October 1, 2011.

One week after CMS missed its deadline, Senators Grassley (R-IA) and Kohl (D-WI), sponsors of the disclosure provisions in the new law, wrote the CMS administrator urging prompt action and asking for a clear timetable for completion of the required guidelines.

Health care trade associations, including the Pharmaceutical Research and Manufacturers of America (PhRMA) and AdvaMed, have similarly urged CMS to finalize its guidelines quickly in order to help companies meet the January deadline. Although some large companies have already started to craft disclosure procedures on their own, Senators Grassley and Kohl expressed concern “that smaller companies are waiting for clarity.”

Responding to Grassley and Kohl at the end of October, CMS Administrator Donald Berwick cited the “stakeholder outreach” efforts his agency staff members have made to develop a regulatory proposal — but provided no timeline or expected date when proposed guidelines would be issued for public comment.

Senator Grassley called CMS’s response “inadequate,” and Senator Kohl stated that “it’s troubling that the response to our letter would come a month late without any indication on progress, a timeline or what caused the delay.”

According to the Senators, a draft of proposed CMS guidelines has been under review at the White House Office of Management and Budget since September.