Buprenorphine Battles Reveal Mixed Results

Pushback on DEA regulations is measured by medication coverage trends that are improving but still lag in many areas.

It was the early days of the AIDS epidemic, and the government wasn't responding fast enough. As depicted in the HBO Films version of And the Band Played On—based on Randy Shilts' poignant account of HIV inaction in the 80s—CDC researcher Dr. Don Francis exclaims that when a house is engulfed in flames, you don't wait. "You grab the first hose and start putting out the fire."

Opioid use disorder (OUD) is also burning out of control—an epidemic that the pandemic exacerbated but also lent relief to. How? By expanding telehealth access to OUD treatment and medications, including buprenorphine.

This year has brought more threats and opportunities for those suffering from OUD. And while some outcomes are uncertain, others are clear, based on a new payer buprenorphine coverage study from Health Affairs.

The common thread is access.

The DEA flinches

The US Drug Enforcement Agency (DEA) has had a change of heart.

In response to "a record 38,000 comments," the agency will continue waivers that allow provider to prescribe controlled substances via telehealth (v-prescribing) and without a prior in-person visit. This gave millions increased access to buprenorphine and other drugs. Buprenorphine helps reduce opioid cravings and withdrawal symptoms.

But in the February 2023 rule that received so much criticism, the DEA proposed to end the waiver with the end of the COVID-19 public health emergency. If it had finalized the rule, in-person visits would again be required for initial controlled substance prescriptions and for buprenorphine refills, effective May 11. Amid backlash, the DEA has extended that date to November 11.

HealthLeaders has covered the proposed rule, its pause, and the broader, dismal state of OUD and substance use disorder (SUD) treatment and reimbursement in the U.S.

AHIP's response to proposed rule

AHIP's response was among the 38,000 that the DEA received.

In its letter submitted during the proposed rule comment period, the national payer advocacy group noted: "While we appreciate the Drug Enforcement Administration's (DEA's) efforts to balance patient access with patient safety, we are concerned that the proposed rule may erect barriers to further innovation in health care and offer several recommendations for consideration."

The AHIP letter, signed by organization SVP Kate Berry, continued that "telemedicine played an outsized role in behavioral health during the pandemic, with nearly a third of behavioral health outpatient visits delivered over telehealth for opioid use disorder and substance use disorder (OUD/SUD) conditions, and with rural residents even more likely to use telehealth for behavioral health conditions. That high level of telemedicine utilization for behavioral health continues even as the public health emergency comes to an end."

Payers step up—and are advised to keep going

While AHIP's response signals payer support for buprenorphine v-prescribing, insurance coverage for the OUD treatment has been a work in progress with more to be done.

Coverage for buprenorphine is the subject of a new Health Affairs study. The results were mixed. On one hand, there was a notable increase in coverage for the immediate-release formulation of buprenorphine from 2017-2021:

• Formulary inclusion — The number increased from 95.4% to 98% among Medicaid payers, 91.3% to 94.7% among Medicare Advantage (MA) payers, and 93.4% to 97% among commercial payers.
   
• Prior authorization (PA) — The percentage of formularies without PA requirements increased to 74.4%, 84.9%, and 94.6% among Medicaid, MA, and commercial payers, respectively.
   
• Quantity limits (QL) — Most Medicaid (97.2%) and commercial (91%) formularies do not impose QLs, but MA is the exception with more than 50% retaining QLs as of 2021.

But this is for the older, immediate-release formulation. Coverage of the newer, extended-release buprenorphine has also increased but lags well behind. The Health Affairs study notes that "only 46 percent of commercial plans and only 19 percent of Medicare Advantage plans cover the extended-release formulation." In contrast, most Medicaid formularies do include it but with 37% requiring PA.

Benefits of the extended-release version include fewer doses (monthly injection versus a daily prescription) and clinician involvement, which can address adherence barriers and medication diversion/misuse, per the study authors.

"Almost all plans covered immediate-release buprenorphine in 2021, with a general trend of decreasing prior authorization requirements and quantity limits since 2017. In contrast . . . only 46 percent of commercial plans and only 19 percent of Medicare Advantage plans [are] covering this formulation."

Shifting access burdens to patients

The Health Affairs authors advise policymakers to "shift their attention to extended-release buprenorphine," adding: "State lawmakers could help address these barriers by mandating that insurers include extended-release buprenorphine on their preferred drug lists."

AHIP expressed a similar concern over OUD buprenorphine and broader treatment barriers in its DEA rule response.

"Our collective experience has demonstrated that telemedicine is an important health care innovation. Telemedicine's value as a modality is supported by recent data—it is a cost-effective, convenient means of delivering high quality care, particularly to traditionally underserved areas and can expand access to care and reduce disparities, especially for rural populations where there is limited access to in-person care."

AHIP continued: "We are concerned that the proposed rule shifts the burden of seeking care to the patient, which is counter to the goal of increasing access to needed care for underserved populations, especially given health care workforce shortages which can result in longer times to get in-person appointments."