Law Raises Patient Limits on Buprenorphine Treatment

The treatment of the growing number of people with opioid addictions will greatly expand under a new law, championed by APA, which will allow expanded use of buprenorphine-based drugs in group practices.

The law, which was signed by President George W. Bush on August 2, was an important victory for APA and the patients who need such treatment.

“We're delighted,” said Nicholas Meyers, director of APA's Department of Government Relations (DGR). “The bottom line is that patients are dying for a lack of access to treatment, and Congress clearly recognized that. Congress also recognized that the 30-patient cap on group practices was not good health policy and was inconsistent with the objectives of earlier legislation.”

The law amends the Drug Addiction Treatment Act of 2000 (DATA), which allows office-based dispensing and prescribing of Schedule III drugs for the treatment of opioid addiction. The law was intended to expand access to treatment beyond the traditional approach of large public clinics to the more convenient offices of qualified physicians.

The DATA 2000 law limited individual physicians to treating no more than 30 patients at a time for opioid addiction. The same 30-patient limit also applied to physician group practices, regardless of the number of physicians in the practice qualified to prescribe the drug. The limit has resulted in many group practices not offering buprenorphine-based drug treatment because of the difficulty of tracking a 30-patient limit across an entire group practice. The law also has severely restricted the treatment of people addicted to opioids, according to the law's advocates.

“The difficulties that have arisen, including the dashed hopes for treatment of many, have resulted in the underutilization of this proven therapy all across this country, including my home state of Michigan,” said Sen. Carl Levin (D-Mich.), the legislation's sponsor, in a floor statement in the Senate.

The law, which is effective immediately, was passed by the Senate last year, but the House was unable to consider it before the end of the 108th Congress. After reintroduction earlier this year, it sped through Congress and passed both the Senate and the House without opposition.

“The bipartisan support and rapidity with which the bill moved are an indication that there was strong support in Congress, and everyone recognized that this was not what they intended when they passed DATA 2000,” Meyers said.

Meyers said APA coordinated the efforts of the American Society of Addiction Medicine, American Academy of Addiction Psychiatry, American Osteopathic Academy of Addiction Medicine, New York City mayor's office, and others to pass the legislation.

The law maintains the 30-patient treatment limit for each individual physician.

The reason for the original 30-patient cap on group practices remains unclear, Meyers said, although the individual physician cap was included to combat doctor shopping by addicts and other abuses. The Bush administration had no objections to the legislation revising the cap, and the Center for Mental Health Services (CMHS) strongly supported it.

The Center for Substance Abuse Treatment reported that at the time the law was signed, 8,609 physicians were trained in buprenorphine treatment, and 5,793 of those physicians had received waivers from the Drug Enforcement Administration to prescribe it. The agency does not know the number of physicians currently prescribing the drug.

In October 2002 the Food and Drug Administration approved the first and only therapies for in-office prescription under DATA 2000—buprenorphine hydrochloride/naloxone hydrochloride (Suboxone) and buprenorphine hydrochloride (Subutex), both manufactured by Reckitt Benckiser Pharmaceuticals Inc. in Richmond, Va.

An estimated 150,000 patients have been treated for opioid addiction since the drugs were introduced in early 2003, according to the manufacturer. Reckitt also estimates 10,000 physicians will be trained in the use of the drugs by the end of 2005.

Information on buprenorphine is posted on SAMHSA's Web site at<http://buprenorphine.samhsa.gov/>.▪