What’s in Store for Opioid Prescription Legislation?
by Gregory J. Pepe
March 1, 2016Coming on the heels of a Connecticut doctor being sent to prison for sloppy prescription of opioids, and a California doctor convicted of manslaughter for her opioid prescribing practices, it is small wonder that the senate confirmation of Dr. Robert Califf to head up the FDA was done amid a cacophony of commentary from politicians claiming the FDA has not done enough to halt the abuse of opioid addiction.
A number of states are starting to adopt legislation which will limit the number of opiate-based pain killers for first time users following routine procedures such as root canals and broken bones. Look for the FDA to follow suit. If history has taught us anything about these kinds of laws, it is that they only serve to spawn dozens of regulations to deal with the necessary exceptions to the original legislation.
Look at the original STARK legislation which started out as “bright line” legislation intended to prohibit physicians from ordering lab tests from labs owned by the physicians. That simple, original concept has now become tens of thousands of pages of legislation, regulations, opinions and precedent, about the scope of the STARK laws and their exceptions. The exceptions alone now run to over 40,000 pages I am told (having never read them all myself). Look for opioid prescription legislation to evolve the same way, as legislators realize that regulations can never be a substitute for the training and reasonable discretion of physicians.
Gregory J. Pepe, founding principal, practices in the areas of commercial finance, healthcare law, alternative dispute resolution and mediation, and general business law. Attorney Pepe represents numerous physician groups, including large integrated practices, IPAs, and PHOs. He has been an advisor to many state medical societies, including the Connecticut State Medical Society regarding physician practice management issues within the context of organized medicine, and regarding initiation of litigation by medical societies against managed care companies.