A major healthcare provider recently announced that it would begin requiring preauthorization for prescriptions of the buprenorphine-based addiction medications Suboxone and Subutex, a move that has raised concern among physicians and patient-advocacy groups about erecting new barriers to treatment.

United Healthcare and its Oxford Health Plans subsidiary announced the new preauthorization policy patients in April, stating, "Effective May 1, 2008, coverage for Suboxone and Subutex will be limited to the uses indicated in U.S. Food and Drug Administration approved labeling and other published clinical evidence. As part of our notification program, your doctor must provide information regarding your condition for which Suboxone and Subutex is being prescribed."

The new policy applies both to new prescriptions and renewals. Doctors writing prescriptions for Suboxone and Subutex now are required to call the company for a 'notification review' ... "We will then send a letter to you and your doctor indicating whether or not your medication is covered under your pharmacy benefit plan," according to the April 2008 letter from Oxford.

Michael W. Shore, M.D., a Cherry Hill, N.J., physician who has 100 current buprenorphine patients and has been prescribing the drug since it first became available for treatment of opiate addiction in 2002, said requiring preauthorization for Suboxone and Subutex was unworkable for both patients and physicians.

Shore, a solo practitioner, said he does not have the time to spend 20 minutes on the phone answering questions about preauthorization. "If this policy is allowed to continue I simply won't take on any new patients who have United Healthcare," he said.

"I think their point [of the policy] is to save money and discourage utilization," continued Shore. "The whole point of the DATA 2000 law [which authorized office-based buprenorphine prescriptions] was to expand access and this is putting impediments up ... Patients can't wait two or three days for a decision to be made. They are in opiate withdrawal and they are going to go out and use. I've had two patients die while waiting for treatment and I won't let it happen again."

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Tim Lepak, president of the National Alliance of Advocates for Buprenorphine Treatment, said that while buprenorphine patients are "really happy to see that more plans are paying for [the drug]," including Magellan, Blue Cross/Blue Shield and Cigna, he said that requiring preauthorization will prevent some patients from getting treatment. "They're putting patients' lives at risk," Lepak said.

Earlier this month, Shore wrote to Richard Justman, medical director of United Healthcare, calling for the policy to be reversed. "If the rationale ... is to somehow reduce treatment costs, I would point out that the efficacious use of Suboxone actually reduces healthcare costs by avoiding the much more costly treatment option of inpatient detoxification and rehabilitation," Shore wrote on May 6. "It is one thing to require preauthorization for inpatient treatment, but to require it for the outpatient option that often eliminates the need for inpatient treatment is penny wise and pound foolish."

In response, Justman wrote on May 8 that United Heathcare's main objective in requiring preauthorization was to prevent off-label prescriptions of Suboxone and Subutex, including for treatment of pain. Justman later offered to meet with Shore and other addiction medicine and addiction psychiatry experts to discuss the policy further.

Robert Lubran, director of the Division of Pharmacologic Therapies at the Substance Abuse and Mental Health Services Administration (SAMHSA), said that the federal agency has fielded a number of complaints about preauthorization of buprenorphine and is working to convene a meeting this summer of health plans, managed-care organizations, health-financing experts, treatment providers, and others. "We want to learn more about the issue and come up with a report that can help clarify what the issues are," he said.

Some other health plans, such as Bethesda, Md., based Coventry Health Care, also require preauthorization for buprenorphine. ValueOptions, a behavioral managed care company located in Norfolk, Va., limits access to the drug in other ways, including a requirement that patients have failed at other types of rehabilitation before being eligible to receive Suboxone or Subutex, limiting reimbursement for prescriptions to six months, and charging a $20 copay.

In 2007, a survey by the Center for a Healthy Maryland found that preauthorization requirements, insufficient reimbursement, and confusing Medicaid rules had made many doctors in the state reluctant to prescribe buprenorphine.

Lubran said that the proposed SAMHSA meeting would provide a current overview of preauthorization practices among health plans nationally.