Medicare Part D Restricts Access To Drug Abuse Treatment

At press time, APA was seeking clarification from the federal Centers for Medicare and Medicaid Services (CMS) about whether medications used to treat individuals for substance abuse—especially buprenorphine and buprenorphine/naloxone and naltrexone—will be included in PDP formularies.

In an August 26 letter to CMS Administrator Mark McClellan, M.D., APA President Steven Sharfstein, M.D., outlined APA's concerns.

“The drugs used for alcohol dependence treatment are acamprosate, disulfiram, and naltrexone,” he wrote. “Each of these drugs has a unique mechanism of action. While all are alcohol-dependence medications, they are not all included in the general therapeutic category and pharmacologic class for alcohol dependence. A specific concern we have is that naltrexone is included under the pharmacological class as an opioid antagonist but is not listed as an alcohol deterrent.”

He also noted that naltrexone might be subject to utilization management because it is not recognized in the pharmaceutical class for alcohol dependence.

He expressed similar concerns about the medications used in the treatment of opioid dependence—buprenorphine, methadone, and naltrexone.

“Each has a unique and significantly different pharmacologic action,” Sharfstein wrote. “The unavailability of these opioid-dependence treatment medications... will restrict access to effective medications since there are no alternative pharmacologic agents of comparable efficacy.

“It is significant that the population that requires medications used to treat substance use disorders is one that will be greatly affected by the Part D benefit,” Sharfstein added. “We are especially concerned about the many dual eligibles who fall into this category. The key issues here—the issues that should drive formulary decisions—are that these drugs are not interchangeable either pharmacologically or therapeutically, that they are highly effective, and that there are no alternate pharmacologic options if they are not available.”

Sharfstein's letter was also signed by Kathleen Brady, M.D., Ph.D., president of the American Academy of Addiction Psychiatry; Michael Brooks, D.O., president of the American Osteopathic Academy of Addiction Medicine; and Elizabeth Howell, M.D., president of the American Society of Addiction Medicine. ▪