July 16, 2019 11:51AM

Will Congress Finally X‑Out the “X” Waiver?

Members of Congress are growing more appreciative of the benefits of Medication Assisted Treatment in addressing the overdose crisis. Two bills presently under consideration—one in the Senate and one in the House—are the latest evidence of that awareness. 

Medication Assisted Treatment for opioid use disorder is one of the most widely-accepted and least controversial of the tools in the harm reduction tool box. The strategy involves placing the patient on an orally-administered opioid that binds with enough opioid receptors to prevent painful withdrawal symptoms while, at the same time, not producing cognitive impairment or euphoria. The approach has been around since the 1960s and has greatly reduced overdose deaths as well as the spread of deadly infections from dirty needles.

One of the oldest and most well-known examples of MAT uses the synthetic opioid methadone, which is classified by the Drug Enforcement Administration as Schedule II (known medical use with a high potential for abuse or dependence). A more recent form of MAT uses the Schedule III opioid buprenorphine. Schedule III drugs have less potential for dependence or abuse than those in Schedule II. Like methadone, buprenorphine is permitted to be prescribed for the treatment of pain, but not for MAT without obtaining DEA permission.

As I have written here, federal policy regarding methadone MAT makes no sense. Health care practitioners have been permitted to prescribe methadone in oral or non-oral forms to treat pain for decades. Yet they are not permitted to prescribe methadone for opioid withdrawal management or for MAT for opioid use disorder outside of a DEA-licensed and regulated methadone clinic. These clinics must also obtain state licenses. Patients are required to take the methadone in front of a member of the clinic staff. 

These regulatory requirements have been great obstacles to providers wishing to establish methadone clinics, and even greater obstacles to patients seeking methadone MAT for their disorder. It also places onerous burdens on patients suffering from opioid use disorder who want treatment. The requirement to take the medication in the presence of clinic staff each day demands a certain amount of scheduling discipline that many addicts have difficulty achieving. It also implies that addicted patients cannot be trusted with an outpatient supply to take as directed —which is a further blow to the already shattered self-esteem that helps perpetuate substance use disorder. And patients living in remote areas underserved by methadone clinics are unrealistically expected to travel long distances each day to take their methadone in the presence of clinic staff. This problem can be alleviated by allowing health care practitioners who can already prescribe methadone for other reasons to prescribe it to outpatients for withdrawal management and MAT, as has been the case in Canada, the UK, Australia and other countries for decades.

Buprenorphine, on the other hand, may be prescribed on an outpatient basis for MAT. Research has been inconclusive with respect to the relative effectiveness of methadone versus buprenorphine for MAT. Most clinicians believe there is no one-size-fits-all answer. Depending upon the patient and the circumstances, one drug might work better than the other. In recent years buprenorphine has been combined with the overdose antidote naloxone in an oral form, commonly known by the brand name Suboxone. When taken orally, naloxone is inactive. If buprenorphine/naloxone is crushed and injected, the naloxone counteracts the buprenorphine, preventing the user from achieving any “high.” But most users of non-prescribed diverted Suboxone report they are self-medicating to avoid opioid withdrawal, and that the Schedule III buprenorphine is a poor substitute for the “high” they get from heroin and other more powerful opioids.

A major force behind the black market for buprenorphine is the fact that there is an acute shortage of practitioners to whom people with substance use disorder can go for buprenorphine MAT. Again, this is because of onerous federal restrictions. Under the Drug Addiction Treatment Act of 2000, practitioners wishing to treat substance use disorder with buprenorphine are required to obtain an “X waiver.” Providers must take an 8-hour course in order to have the ”X” added to their DEA narcotics prescribing license. There are also strict limits on how many patients a practitioner can treat at any given time, as well as restrictions on nurse practitioners or physician assistants wishing to obtain the X waiver. These have combined to create an acute lack of buprenorphine MAT providers. According to the Substance Abuse and Mental Health Services Administration, less than 7 percent of practitioners have jumped through the hoops and obtained X waivers. The shortage is particularly severe in rural areas. Nationally, only 1 in 9 patients with opioid use disorder are able to obtain buprenorphine MAT.

For this reason, health care practitioners interested in treating opioid use disorder, as well as other harm reduction advocates, have called for ending the requirement of an X waiver to use buprenorphine for MAT. In France roughly one-fifth of general practitioners treat people with substance use disorder in their offices without any further licensing or education requirements. It has contributed to a dramatic reduction in France’s overdose death rate.

Fortunately, members of Congress seem to be getting the message. Senators Lisa Murkowski (R-AK) and Maggie Hassan (D-NH) have introduced a bill that would eliminate “the separate scheduling requirement for dispensing narcotics in Schedules III, IV, and V for maintenance or detoxification treatment.” In the House, Representative Paul Tonko (D-NY) introduced HR 2482 in May which does the same. HR 2482 has 75 co-sponsors, 15 of whom are Republicans.

It should be a lot easier for providers to help the many patients seeking help from their disorder but are are unable to find it. This legislation should help. Congress should also look at reforming laws surrounding methadone, so it can be prescribed in practitioners offices as well. But first things first.