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CMS Proposed Rule Defies White House Policy on Abuse-Deterrent Medications

By Michael C. Barnes 

A classic example of bureaucratic defiance is playing out right now over federal strategies to reduce the nation’s prescription drug abuse epidemic. An estimated 22,767 Americans die each year involving prescription drug overdose. The Centers for Disease Control and Prevention warns that the epidemic has contributed to higher rates of heroin use and transmission of HIV and hepatitis C.

The Obama administration deserves credit for aggressively addressing prescription drug abuse in ways that demonstrate compassion for people on both sides of the issue: those who need medications and those who have substance use disorders. For example, the administration has made more educational resources available to prescribers, funded state prescription monitoring programs, and markedly expanded access to treatment for substance use.

Another way the Obama administration has balanced medication access and abuse prevention is by supporting the development and use of abuse-deterrent medications. Abuse-deterrent medications are reformulated to limit the potential for diversion, misuse, and abuse via improper routes of administration, such as crushing or melting. The White House Office of National Drug Control Policy, Food and Drug Administration, Centers for Disease Control and Prevention, Substance Abuse and Mental Health Services Administration, National Institute of Drug Abuse, and Drug Enforcement Administration are all working in support of administration policy on abuse-deterrent medications. A bill before Congress would go a step further by giving drug makers a deadline by which to make the most powerful yet risk-prone controlled substances abuse deterrent.

Transitioning to abuse-deterrent medications makes senses, especially in light of a recent Washington University study that found that the abuse-deterrent formulation of extended-release oxycodone curtailed its abuse by 35-40 percent.

Unfortunately, the Centers for Medicare and Medicaid Services (CMS) is out of line when it comes to administration policy on abuse deterrents. Under federal law, CMS has the authority to keep drug makers from charging the government more after making merely insignificant changes to previously available medications. CMS can require manufacturers of these “line extension” products to give the government a higher rebate. In 2012, CMS proposed a rule that subjects abuse-deterrent medications to this steeper line extension rebate. The rule is expected to become final in the coming weeks.

The CMS policy undermines the otherwise coordinated national effort to help people who need powerful medications get less risky versions of them. Deeming the benefits of abuse-deterrent formulations inconsequential renders the lives saved by reducing abuse by 35-40 percent equally insignificant. It also sends a strong signal to drug manufacturers that investing in making products safer does not pay off.

What is, perhaps, most frustrating about CMS’s approach to abuse-deterrent medications is its bureaucratic brazenness. While writing off the benefits of abuse deterrence might help the agency save money in the short term, it costs the federal government and American families much more in the long term. The Centers for Disease Control and Prevention estimates that lost productivity, health care treatment, and criminal justice costs due to prescription drug abuse total $55.7 billion each year. That figure does not even come close to the value of the 22,767 American lives lost each year to overdose.

The White House weighed the costs to the federal government and benefits to society of abuse-deterrent formulations and issued a policy that supports the development and adoption of these new medications. It is time for CMS to get in line.

Published in The Hill on September 9, 2015.

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