Government Eliminates Waiver Requirement for Doctors Prescribing the Addiction Treatment Medication
Under new US Department of Health and Human Services practice guidelines, physicians will no longer have to go through the cumbersome process of obtaining a federal waiver to prescribe the opioid use disorder (OUD) treatment buprenorphine to patients. Eliminating the Drug and Alcohol Enforcement (DEA) waiver regulation requirement – long viewed as a significant hurdle to increasing access to OUD treatment medications – is expected to help promote the use of medications for OUD across a range of settings. Providers and policymakers have described the waiver process as antiquated and burdensome, hindering their ability to adequately address the ever-burgeoning opioid crisis. This change was made under the Secretary’s authority to issue practice guidelines and exemptions to the regulatory requirements for buprenorphine prescribing. It does not change existing federal law, though this may signal that such legal change is on the horizon. A bill introduced in 2019 by US Rep. Paul Tonko of New York to remove the waiver requirement language for all eligible prescribers remains alive in the House of Representatives, awaiting action. The incoming Biden Administration could swiftly retract this new guidance, but given the momentum toward removing barriers to OUD treatment, it is not expected to be repealed. The new administration is more likely, in alignment the campaign’s opioid epidemic plan’s emphasis on access to treatment, to codify such an expansion in providers’ ability to treat. Before the waiver was eliminated, doctors had to: Complete eight hours of training and complete an application to the Substance Abuse and Mental Health Services Administration. Once granted a waiver, they could prescribe to a maximum of 30 patients for the first year. After a year, they could submit another application to increase their patients to 100, and eventually serve up to 275 patients. Providers have described the waiver process as antiquated and that ability to prescribe to only 30 people in the first year hindered their ability to adequately address the opioid crisis. Because the waiver requirement was previously required for physicians in order to prescribe the medication component of OUD treatment services according to federal law, states similarly imposed this requirement in their own approaches and may need to take steps to re-align policy with the new federal guideline:
States that integrated buprenorphine prescribing practices into their licensing regulations for prescribers may need to amend regulations to reflect changes to physician requirements. In some states, such regulations are also intended to promote prescribing safety, requiring that providers document connections to counseling and other supports, an effort designed to minimize potential diversion of buprenorphine. States could take steps to maintain – or even strengthen – these requirements, as diverted buprenorphine remains a concern to public safety policymakers.
As states have worked to build treatment capacity for OUD, they have integrated the required training for the waiver into their efforts, often partnering with professional associations to provide the in-person training hours. States have also dedicated funding to these trainings in both state budgets and via State Opioid Response (SOR) grant dollars. Because waiver trainings will now only be required for non-physician prescribers, states may need to quickly shift training plans and provider association partners.
Reimbursement for these services may be administratively tied to the requirement to have a waivered prescriber among OUD care team members. As states have developed Medicaid waiver demonstrations and amended state plans to include OUD treatment services, language requiring waivered prescribers was incorporated to align with the federal policy. All of these documents, directives, and billing practices will need to be amended by states to ensure that physicians – now without the waiver – can seek reimbursement.
States can leverage this policy change to address many of the challenges that were previously posed by the waiver requirement in expanding access to this life-saving treatment:
By allowing all licensed physicians to prescribe buprenorphine to a maximum of 30 patients in their first year, this policy change helps to normalize OUD treatment as part of health care, reflecting a long trend of integrating behavioral health and primary care practices. This helps to create administrative ease for providers and payers and reduces logistical barriers for patients.
Stigma regarding OUD has long posed a challenge for states in their efforts to expand treatment capacity, and this change at the federal level represents a sanctioning and approval of this component of treatment that may help to alleviate that stigma.
Emergency departments have been increasing their efforts to transition individuals who use opioids and have overdosed to buprenorphine, though this approach previously required that a waivered prescriber be present at all times in the hospital setting. All emergency department physicians will now be able to administer buprenorphine onsite if necessary.
While this change opens up opportunities for physicians to expand their OUD treatment services, it also leaves many practical questions unanswered. Non-waivered physicians who previously did not obtain the waiver and who decide to begin prescribing buprenorphine in light of this new policy may want additional guidance from their states to feel comfortable prescribing, particularly for non-waiver education and billing practices. The National Academy for State Health Policy (NASHP) will continue to follow policy changes in the treatment of OUD as they emerge from Congress and the incoming Biden Administration.