Health care institutions and providers, medical device manufacturers, pharmaceutical and biotechnology companies and all other segments of the health industry have a unique opportunity to submit comments to the U.S. Department of Health and Human Services’ (HHS) newly formed Advisory Committee on Regulatory Reform about strategies for reducing regulatory burdens.
On January 4, 2002, HHS invited comments, due by March 5, 2002, from interested parties on ways to reduce regulatory burdens in the areas of health care delivery, health care operations, development of pharmaceuticals and other medical products and biomedical and health services research.
The Bush administration created the Committee, with much fanfare, to provide findings and recommendations regarding potential regulatory changes and to bring "more common sense into the regulatory process," according to HHS Secretary Tommy Thompson. The Committee will report to Assistant Secretary for Planning and Evaluation Bobby Jindal, who was a finalist for the position of administrator of the Centers for Medicare & Medicaid Services. The Committee provides a focal point for health care companies and those served by them to bring major issues to the attention of HHS for possible fixes. In addition to seeking comments from the public, the Committee will hold a series of regional hearings.
The Federal Register notice specifically asks commenters to help the Committee identify regulations that are confusing; impose unnecessary or excessive costs; require an excessive number of reports or unreasonable record keeping; carry excessive penalties; conflict with other HHS or state regulations; impede access to care or efforts to innovate; or interfere with the ability to respond to and prepare for emergencies. The notice asks commenters to propose alternative approaches to accomplish the regulatory goals with reduced burdens.
The Federal Register notice is available at http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2002_register&docid=02-239-filed.pdf .
The Committee’s call for comments focuses on problems caused by regulations adopted by HHS, rather than statutes passed by Congress. The call for comments does not address the fact that many burdens arise not from regulations themselves, but from administrative interpretations of regulations, provisions in manuals, instructions in forms, or other publications short of formal regulations. Nonetheless, the Committee provides a unique opportunity for the health community to raise issues that significantly affect their business. The industry’s response to the call for comments may well shape political perceptions about how reasonable HHS’ regulatory system is for several years to come.