Eliminate the X Waiver for Buprenorphine Prescribing?

The federal government has eased restrictions on the “X waiver” that physicians need to prescribe buprenorphine and other medication-assisted treatments for opioid use disorder (OUD), but Kristin Mack, DO, wants more — she’d like to see the waiver eliminated entirely.

“This needs to be treated just like any other chronic medical condition,” said Mack, a family physician in Ticonderoga, New York, speaking in a phone interview. Requiring the waiver “reduces our patients’ access to this type of treatment, which has good evidence behind it.”

Mack is the author of a resolution to be presented at the upcoming American Academy of Family Physicians Congress of Delegates meeting; the resolution calls for the AAFP to lobby for the X waiver to be eliminated. The delegates’ meeting normally would have been held this month in conjunction with the AAFP’s FMX meeting, but it was postponed until next spring due to the COVID-19 pandemic.

Previously, primary care physicians who wanted to treat OUD patients with medication, particularly buprenorphine, had to obtain the waiver, which required them to undergo 8 hours of training and offer counseling to patients. In January, the outgoing Trump administration issued guidance eliminating the waiver for physicians who treated no more than 30 OUD patients at a time, as long as they prescribed buprenorphine and not methadone. Physicians using the X-waiver exemption would have to put an “X” on the prescription, clearly state that the prescription is being written for opioid use disorder, and maintain separate charts for patients being treated for OUD.

In April, the Biden administration issued similar guidelines and added physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives to the list of clinicians who qualified for the exemption. The new guidelines also eliminated requirements for prescribers to undergo 8 hours of training and to offer counseling to OUD patients. Those wanting to treat more than 30 patients still need to get a waiver.

Mack’s resolution notes that “there is overwhelming evidence demonstrating medications for opioid use disorder (MOUD) reduce drug use, disease rates, overdose, death, healthcare expenditure, and crime” and that “despite such compelling evidence, 90% of patients with OUD in the United States do not have access to MOUD and only 23% of publicly funded treatment programs offer FDA-approved MOUD and less than 50% of private-sector treatment programs offer FDA-approved MOUD.”

It asks that the AAFP “advocate for the elimination of the X waiver and oppose any additional future requirements that limit the ability to prescribe buprenorphine.”

If the waiver was eliminated, wouldn’t that allow untrained physicians to prescribe buprenorphine? “We’ve been talking to graduate medical education programs in terms of residency programs, and we’re looking to ‘require’ this training to be done as part of training programs,” said Mack. “As we go forward, we see young trainees and the people that are new to the profession, doing exactly what we hope the future is, which is to treat this as a chronic medical condition as a regular part of an office visit, and not to have it ‘subspecialized’ out. So that’s my ideal situation, is to see every family medicine doctor able to do this.”

Treating patients for opioid addiction is very rewarding, said Mack, who got her own X waiver shortly after finishing her residency in 2014 and now helps to train other physicians who want to get the waiver.

“Throughout my career, I have been able to build some of my best trusting relationships with [OUD] patients when I see them frequently and provide medication treatment,” she said. “I’ve had wonderful experiences where I get to watch somebody really get back to ‘normal’ life, where they can maintain their employment and have a better family life, and financial obstacles that are related to addiction go away for them.”

The ability to provide MOUD is important for physicians in rural areas like hers, she added.

“My patients don’t have other places to go,” she said. “We work really hard with community resources to provide the counseling and things like that. But if I were to tell somebody, ‘Oh, you have to go an hour away to a city to get care for this’ and then they need to be seen monthly, it’s just not an option. And rural communities are some of the hardest hit by the opiate epidemic.”

Asked for comment on the idea of eliminating the waiver, a spokesperson for the Substance Abuse and Mental Health Services Administration (SAMHSA) noted that the waiver was established under the Drug Addiction Treatment Act of 2000 — otherwise known as the DATA 2000 Act — and Congress would need to write a new law if it wanted to eliminate the waiver.

The spokesperson also noted that in April 2020, the law was adjusted to allow for telemedicine prescription of buprenorphine, including via telephone, under guidance issued jointly by the Drug Enforcement Administration and SAMHSA.

“SAMHSA will refrain from commenting on planned Congressional action,” its spokesperson said.