A final rule from the Substance Abuse and Mental Health Services Administration increased the number of patients a doctor can treat with an opioid addiction medication.
Historically, doctors could treat only 30 patients at a time in the first year they're certified to prescribe buprenorphine. They could then receive authorization to go up to 100 patients in subsequent years.
Given as many as 2.2 million people are believed to have opioid use disorder, the cap was viewed as too restrictive and doctors would often have to turn away patients in need of treatment.
Now providers will be able to treat as many as 275 patients at a time (PDF), which is nearly three times higher than the previous limit. The new rule requires practitioners to have an active waiver to treat up to 100 patients for one year and additional credentialing in addiction medicine or addiction psychiatry or practice in a qualified practice setting.
Practitioners seeking the higher patient limit must adhere to a number of requirements including offering patients behavioral health services such as addiction treatment counselors. They must also use patient data to improve outcomes and participate in strategies to prevent patients from giving their prescribed opiates to another person illegally.
Practitioners in the program will need to reaffirm their eligibility every three years.
Providers were pleased with the final rule as it increased the upper cap limit from a proposed 200 patient limit to 275. SAMHSA said it did so in part due to the public comments.
Doctors had warned the limits in the proposed version of the rule would have likely have made a small dent in the battle to curb opioid abuse.
The rule takes “an important step toward closing the well-documented addiction treatment gap,” Dr. Kelly Clark, president-elect of American Society of Addiction Medicine (ASAM) said in a statement.
ASAM also expressed support for the agency decision to delay implementation of proposed reporting requirements for doctors requesting the new upper limit. Some of the proposed tracking stats included the average monthly caseload of patients receiving buprenorphine per year and the percentage of active buprenorphine patients that received psychosocial or case management services.
“While HHS received many comments on the burden of these requirements, the comments did not provide specific suggestions on how HHS can ensure compliance in a manner that is not overly burdensome to practitioners,” the agency said. It is now seeking additional comments on the issue until Sept. 8.
In the coming weeks, SAMHSA plans to conduct outreach to an estimated 50,000 practitioners about the final rule. That number includes 30,000 practitioners already authorized to prescribe buprenorphine.
The agency estimates that between 500 and 1,800 practitioners will request approval to treat up to 275 patients within the first year of the rule, and between 100 and 300 additional practitioners will request approval to treat up to 275 patients in each of the subsequent 4 years.
Five years after the rule's implementation nearly 70,000 additional patients are expected to be treated with the drug, SAMHSA estimated.