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Should 'X-Waiver' Be Nixed?

— Relaxing "bupe" training requirement is last thing Congress should do, says GOP doc

Ƶ MedicalToday
A bottle of Buprenorphine and Naloxone sublingual tablets over a photo of drug paraphernalia

Lawmakers on Wednesday discussed ways to remove barriers to accessing treatment for substance use disorder during a hearing of the Health Subcommittee for the Committee on Energy and Commerce.

From eliminating the training requirements for buprenorphine prescribing, to take-home doses of methadone, there was no shortage of ideas, albeit controversial ones.

The subcommittee also examined the "two-track" response to dealing with opioids that seems to diverge based on race and ZIP code.

Subcommittee Chair Anna Eshoo (D-Calif.) explained that the need to resolve access and equity issues could not be more urgent, noting that overdose deaths spiked after the start of the pandemic, and culminated in over 88,000 deaths in the 12 months leading up to August 2020 -- making last year "the deadliest year for overdoses on record."

Rep. Tony Cardenas (D-Calif.) noted that drug use is just as prevalent in Beverly Hills as it is in the less affluent and more racially diverse Pacoima neighborhood in Los Angeles where he grew up.

But the approach to dealing with substance use in each community differs dramatically: In Beverly Hills, he said, the knee-jerk reaction to a person with substance use is, "Oh my gosh ... little Johnny's addicted ... We gotta put him in a program," while a few miles away the standard of care for someone with a substance use problem is "hook-em and book-em, send the cops in."

As a result, "you have people on one side of town who are behind bars, not addressing the issue of addiction, but on the other side of town the person is actually getting support," Cardenas said.

Regina LaBelle, JD, acting director for the Office of National Drug Control Policy (ONDCP), did not disagree.

"Certainly, some people get healthcare ... and others are incarcerated," she said.

This "two-track system" of responding to substance use is something her office highlighted as a policy priority in a recent ONDCP report.

"I think that's been with us for a very long time, and we're going to work on that," she said.

President Biden has committed to reducing the rates of incarceration and not criminalizing "drug possession alone," LaBelle said. Improving data around these disparities, and increasing the diversity of the work force can also help, she added.

Rep. Robin Kelly (D-Ill.) raised similar concerns about equitable access to care, citing the same ONDCP report, which found that Black people enter treatment for substance use disorders 4 to 5 years later than white individuals.

Asked whether the administration had plans for ensuring that Black Americans receive "more timely access" to evidence-based treatment, LaBelle said her office plans to examine the data and to work with HHS on these issues.

Rather than quickly stand up a program that only "sounds good" or "looks nice," the administration wants to implement programs and policies that will "make a difference once and for all on this issue," she said.

Change won't happen overnight, she warned, but the first step is to acknowledge the problem.

Expanding the Workforce

Forty percent of counties in America lack even a single waivered clinician who can provide buprenorphine, Kelly said.

She asked LaBelle how the Biden administration plans to expand access to care.

LaBelle pointed out that methadone clinics are another option, but acknowledged that care in such clinics is far less private and less personal.

Expanding the number of clinicians providing buprenorphine to include more nurse practitioners and physician assistants would help to address gaps in access, she said.

Questions around X-waivers -- which are requirements for prescribing buprenorphine -- surfaced multiple times during Wednesday's hearing.

Kelly asked LaBelle whether it was counter-intuitive to require a waiver for prescribing buprenorphine when no training is required to prescribe opiates.

LaBelle said healthcare professionals have only "minimal" education in addiction, so the 8-hour X-waiver training may help those clinicians who don't regularly encounter substance use.

But "I think what we really need to do," LaBelle said, "is expand the number of people in our healthcare system who understand how to screen and treat and help people recover from addiction, as opposed to hinging it all on this one medication."

Taking a different point of view, Rep. Larry Bucshon, MD (R-Ind.), argued against relaxing the rules and allowing "almost anyone regardless of their qualifications and/or training to prescribe buprenorphine."

Bucshon slammed a new bill, the " saying it would eliminate mandated training requirements and expand access only to medication and not to "real and effective treatment" for people with substance use disorders.

Anyone "legitimately" working in the field of mitigating substance use understands the importance of "a comprehensive treatment plan," Bucshon said.

Buprenorphine is "one of the most highly diverted drugs in this country," and relaxing requirements for prescribing it is "the last thing Congress should do," he said.

Rep. Paul Tonko (D-N.Y.) who authored the bill, defended it by reading aloud from written by multiple advocates for people with behavioral health problems including Shatterproof, Mental Health America, the National Association of Attorneys General, and other stakeholders:

"The existence of the X-waiver sends a terrible message to practitioners and the public alike: that treating OUD [opioid use disorder] with buprenorphine requires separate stigmatizing rules and that buprenorphine is inherently more dangerous than the powerful opioids that have fueled this crisis."

The X-waiver process stigmatizes substance use and sends a message to providers that they aren't equipped to treat people with substance use disorders, Tonko said.

Asked whether she agreed, LaBelle acknowledged the danger of stigma across our addiction system, adding that "the buprenorphine waiver is just one element."

Tonko thanked LaBelle for keeping an open mind.

Modernizing Methadone Treatment

Members of the subcommittee also spoke about ONDCP's plans to modernize methadone regulations.

Rep. Debbie Dingell (D-Mich.) asked LaBelle how soon Congress could expect a review of the rules.

Methadone regulations haven't been reviewed "for some time," LaBelle said, noting that the office's policy priorities were only issued on April 1. She agreed to provide Dingell's office with more information once "a venue" for that review had been determined.

Dingell noted that while during the pandemic, rules about administering methadone remain rigid.

Asked whether the requirement that all new methadone patients have an in-person appointment limited access to treatment, LaBelle pointed out that making sure that patients receive the appropriate dose is important, which is one reason to meet in-person.

However, "those are issues that we need to make sure are reviewed," LaBelle added.

She also noted that methadone treatment vans could provide one solution to access issues.

Mobile treatment is particularly beneficial in jails that may lack a treatment program, she said. "I am a strong proponent of mobile methadone vans, and we're working diligently to make sure that those get out as soon as possible."

At another point in the hearing LaBelle also cited the possibility of providing "take-home doses" of methadone at clinics, and engaging patients in telehealth as "a great way to remove a barrier for someone who might otherwise not be able to continue in treatment and might be subject to overdose."

Rep. Michael Burgess, MD (R-Texas), noted that the risk for diversion with methadone is "significant," and "that has to be borne in mind."

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    Shannon Firth has been reporting on health policy as Ƶ's Washington correspondent since 2014. She is also a member of the site's Enterprise & Investigative Reporting team.