The federal government has proposed lifting the buprenorphine “cap” — the highest number of patients a physician can treat for opioid use disorders with the medication — from 100 to 200. In a Notice of Proposed Rulemaking (NPRM) published in the Federal Register March 30, the federal Department of Health and Human Services (HHS) issued the long-awaited decision on expanding access to opioid treatment by raising the cap. Physicians who continue to treat up to 100 patients would be under no extra conditions; under the NPRM, there would be additional reporting requirements but only for those providers who had received approval to treat up to 200 patients.

Throughout the lengthy NPRM, there is no mention of drug testing, and counseling must be reported only if a buprenorphine provider refers a patient to it. No counseling or drug testing is required.

HHS had made it clear last year, when Secretary Sylvia Burwell first announced that the proposal was forthcoming, that it would be cautious in lifting the cap. At the time, Richard G. Frank, Ph.D., HHS assistant secretary for planning and evaluation, told us that the agency wanted to make “sure that counseling and drug testing are in place” (see ADAW, Sept. 28, 2015).

In fact, the caution appears to have been in the number itself: while many physicians and treatment advocates had hoped the cap would be 300, 500 or even unlimited, the actual rise to 200 did not impress them. But the fact that they are clamoring to treat more contradicts the overall numbers, which show that many physicians are not treating to capacity.

Current system not full

The problem is that many physicians who already have waivers to treat buprenorphine patients are not doing so. The capacity nationally is only 57 percent, according to HHS, which means that 43 percent of slots are still open. This could be because of geographic disparities in opioid use disorders, or other reasons.

Through 2016, there are 21,697 physicians with waivers to treat 30 patients, and 10,426 to treat 100 patients. Nobody knows what they are doing in treatment, whether they are doing counseling or drug testing, or why they are not treating to capacity, Frank told ADAW last week.

“I’d call it a paradox,” Frank said. “On the one hand, you have doctors with 100 patients who have waiting lists, and on the other hand, you have a bunch of doctors who don’t use their full opportunity,” he said. “We don’t fully understand why that is. It’s clear that there’s a constraint in one place and not the other.”

And Frank said that the caution in the NPRM is not only in the 200 limit; it’s that more requirements have been added as well.

Asked about requirements for counseling, Frank noted that if providers refer patients to treatment, they need to report how many got such referrals and whether the patients went to treatment. Asked about drug testing, he said, “We don’t have a specific metric on that.”

Opioid treatment programs (OTPs) are very tightly regulated: they dispense methadone, and can now also dispense buprenorphine. Their per-patient costs are similar (about $4,000 a year) to the per-patient costs estimated for patients in 200-patient buprenorphine office-based opioid treatment (OBOT), mainly because the cost of buprenorphine is so much higher than the cost of methadone. So why don’t physicians who want to expand their patient cap with buprenorphine open OTPs? “There was nothing stopping these folks from having an OTP,” said Frank. “But the world did not take care of itself.” So instead, HHS is “increasing the opportunities for people and using office-based practices to do it — but in a way that is cautious.”

The NPRM does leave a provision for technology — such as the buprenorphine implant, still not approved, but which may change the patient cap. While this could be done via subregulatory guidance, Frank said it’s important to “leave the door open to say that these patients may be counted differently, and we would like to get some thoughts from the field on it.”

Responses from the field

The American Society of Addiction Medicine (ASAM), long an advocate for raising or eliminating the cap, views this NPRM as a start. “Increasing the buprenorphine cap to 200 patients is an important first step,” said Jeffrey Goldsmith, M.D., ASAM president. “The American Society of Addiction Medicine believes it is vital to continue pressuring Congress to assure that access to treatment is increased through legislation.”

Stuart Gitlow, M.D., immediate past president of ASAM, was not so sanguine. “I’m concerned,” he told ADAW. “There is no limit to the number of prescriptions for full-agonist narcotics that can be written. There is no limit to the number of prescriptions for benzodiazepines that can be written. In fact, there is no limit to treating any patient with any medication except for the one on buprenorphine, a partial-agonist narcotic which is far safer and less risky than medications readily available without limitation.” The continued restriction will lead to continued diversion, which Gitlow blames on the cap. In addition, the increased regulatory oversight and paperwork will discourage many providers from applying for the 200-patient limit, he said. “Why would we increase our burden and costs here, specifically for use of a comparatively safe medication, other than due to the stigma alone of treating patients with addictive disease?”

Amanda Wilson, M.D., CEO of CleanSlate, a chain of buprenorphine clinics based in Massachusetts, has several concerns about the NPRM. First of all, midlevels (nurse practitioners and physician assistants) are not allowed to prescribe. She noted that President Obama mentioned this option as a way to expand access to treatment in rural and other underserved areas at the Rx Drug Abuse and Heroin Summit in Atlanta last week. Second, she said she thinks the incremental way that prescribers’ capacity is adjusted under the NPRM is “limiting and arbitrary,” in that a provider may have never seen a patient at all during the three-year ramp-up from 30 to 100 to 200 patients. This shows that the cap “is not imposed to ensure experience with the patient population,” she told ADAW. “Given the numbers of overdose deaths, a three-year delay to 200 patients seems arbitrary and unnecessary and probably very risky for public health.” And finally, she feels only a small subset of the 7,000 physicians who have submitted the notice of intent to treat 100 patients would be interested in treating 200, because of the strict reporting requirements and requirements for board certification. “Perhaps 2,000” physicians would apply to treat 200 patients, she said. “This will not meaningfully improve access to care,” she said.

Still, Wilson agreed that there need to be diversion protocols in place to minimize the risks of the “development of bupe mills.”

From H. Westley Clark, M.D., the review of the NPRM is good. “I would think that this would be an opportunity to promote a systems change, with ACOs, CHCs, MCOs, HMOs, and CMHCs mobilizing their doctors to address this issue in the integrated setting,” he told ADAW. Clark presided over many federal buprenorphine cap discussions as director of the Center for Substance Abuse Treatment at the Substance Abuse and Mental Health Services Administration, which is in charge of the buprenorphine waive process. He considers himself pro-buprenorphine, he said. But he is also concerned about diversion. “Until satisfactory delivery models have been institutionalized, care should be taken in expanding access, lest buprenorphine become the new OxyContin,” he said.

Comments are due by May 31. For the NPRM, and information on how to comment, go to https://www.federalregister.gov/articles/2016/03/30/2016-07128/medication-assisted-treatment-for-opioid-use-disorders.

Bottom Line…

The long-awaited proposal to raise the patient cap on buprenorphine is out: physicians can apply to treat up to 200 patients, with stricter reporting and paperwork requirements.