For the 2.4 million Americans with an opioid use disorder, the over 10 million who abuse prescription opioids, and the nearly one million heroin users, access to medication-assisted treatment (MAT) is critically important, according to the National Institute on Drug Abuse (NIDA) and Substance Abuse and Mental Health Services Administration (SAMHSA) guidelines.  However, new research suggests there are problems in patient access to medication-assisted treatment, particularly in some state Medicaid programs, and in the availability of experienced physicians with the necessary federal certification.

Background on Buprenorphine

Opioid use disorder involves both an addiction to and dependence upon opioids.  Medications, particularly buprenorphine (long-acting partial opioid agonist), are used in combination with behavioral therapies and counseling to treat addiction to and dependence on prescription opioids and heroin.  While methadone may be provided to patients only through highly structured specialized clinics, buprenorphine may be prescribed or dispensed in physician offices, correctional facilities, public health clinics, emergency departments, and hospitals (subject to federal restrictions described below). Also, methadone accounts for a disproportionate share of opioid-related overdoses and deaths.

Buprenorphine has unique pharmacological properties making it, when properly used, highly effective in reducing opiate use and in reducing withdrawal symptoms and cravings caused by a physical dependency on opioids.  It is now sometimes used to assist in opiate detoxification.  As an opioid partial agonist, buprenorphine produces effects similar to opioids, such as euphoria, but the effects are weaker and the opioid-like effects level off at moderate doses, creating a ceiling effect.  Coupled with it being a long-acting agent that many patients do not need to take daily, this lowers both potential side effects and the relative risks of misuse and dependency while providing some increased safety in cases of overdose.  But it is a powerful medication and safeguards are necessary to prevent misuse and diversion.

NIDA-supported discoveries in basic and clinical research led to the development of buprenorphine, with the FDA first approving commercial products in October 2002.  For the US market, the FDA has approved four basic types of buprenorphine-based prescription drug products, each a Class III controlled substance:

  • Bunavail (buprenorphine and naloxone) buccal film
  • Suboxone (buprenorphine and naloxone) film
  • Zubsolv (buprenorphine and naloxone) sublingual tablets
  • Buprenorphine-containing transmucosal products for opioid dependency

Under the Drug Addiction Treatment Act of 2000 (DATA 2000), prescribing and dispensing buprenorphine in the broader range of clinical settings mentioned above is subject to additional regulation.  Physicians must complete an 8-hour course, must obtain a waiver from the U.S. Drug Enforcement Administration (DEA), and are limited in the number of their patients being treated using buprenorphine.  Initially, qualified prescribers are certified to care for a maximum of 30 patients.  After a year, they may request federal permission to use buprenorphine in treating up to 275 patients as part of an evidence-based opioid recovery program (this was increased from 100 in a new SAMHSA final rule, effective August 8, 2016).  SAMHSA maintains an online database of physicians certified to provide medication-assisted treatment of opioid addiction and dependency.

Use of Opioid Recovery Medications in Medicaid, Medicare Part D, and Private Health Insurance

new analysis by the IMS Institute for Health Informatics of the prescribing patterns and payer mix for buprenorphine show wide state-by-state variation in Medicaid, Medicare Part D, and private health insurance.  Most troubling, the IMS Health report – Use of Opioid Recovery Medications: Recent Evidence on State Level Buprenorphine Use and Payment Types – suggests a problem in accessing medication-assisted treatment using buprenorphine, particularly in a number of state Medicaid programs.

This is especially worrisome given how opioid misuse, overprescribing, abuse, addiction, and overdose death rates are all more severe in Medicaid.  To learn more about the staggering opioid problem in Medicaid and some best practices in addressing it, please read Best Practices for Addressing Prescription Opioid Overdoses, Misuse, and Addiction, a useful 15-page informational bulletin from the Center for Medicaid and CHIP Services (CMCS) at the Centers for Medicare and Medicaid Services (CMS).

Research shows the opioid epidemic has a disproportionate impact on Medicaid beneficiaries. Medicaid beneficiaries are prescribed painkillers at twice the rate of non-Medicaid patients and are at three-to-six times the risk of prescription painkillers overdose. North Carolina found that while the Medicaid population represented approximately 20 percent of the overall state population, it accounted for one-third of drug overdose deaths, the majority of which were caused by prescription opioids. One study from the state of Washington found that 45 percent of people who died from prescription opioid overdoses were Medicaid enrollees. – Vikki Wachino, Director, Center for Medicaid and CHIP Services, Centers for Medicare and Medicaid Services

Here are the highlights from the IMS Institute’s eye-opening, 24-page analysis:

  • The number of prescriptions dispensed through retail pharmacies for buprenorphine medications reached 12.5 million in the twelve months ending June 30, 2016, an increase of 6.4 percent from the prior year.
  • Growth in the use of buprenorphine medications has slowed over the past five years even as there has been an increase in the calls for action to support opioid addiction recovery programs and growing evidence and recognition that medication is key to long-term recovery for patients.
  • Medicaid programs account for 24% of total buprenorphine prescriptions nationally, with commercial insurance plans covering 57%, Medicare Part D plans covering 7%, and the remaining 11% of prescriptions being paid for in cash.
  • States vary widely in the extent of Medicaid funding of buprenorphine use, with more than 40% of buprenorphine prescriptions covered by Medicaid programs in eight states, while in twelve states that coverage is less than 10%.
  • Those states with expanded Medicaid coverage are likely to have a higher proportion of buprenorphine prescriptions covered by Medicaid and a smaller proportion paid for by cash compared to states that have not expanded Medicaid coverage of buprenorphine.
  • Of the ten states with the highest prescription opioid use relative to their population, eight states have a lower than national average level of Medicaid funding for buprenorphine use.
  • Patient access to – and reimbursement for – buprenorphine medications used in addiction recovery programs varies widely across states and suggests inconsistent and suboptimal approaches in many parts of the country.

The full analysis, built on a series of informative charts and with state-specific data tables, is available free here (PDF).

The study was conducted independently by the IMS Institute for Healthcare Informatics with funding support from Advocates for Opioid Recovery, a nonpartisan effort founded and led by Newt Gingrich, Patrick Kennedy, and Van Jones.

Barriers in Securing Medication-Assisted Treatment for Opioid Use Disorder

Meanwhile, a new NIDA-sponsored study of physicians and addiction specialists certified to provide buprenorphine-assisted treatment of opioid addiction and dependency shows that many federally-approved prescribers serve only a small fraction of the total number of patients permitted under federal rules.  While the strict limits described above have caused concerns that federal restrictions prevent patients from receiving recommended treatment, the data show prescribers are seeing so few patients the caps are often not a factor. Further, the data show that for many patients who do receive treatment, the duration of medication-assisted treatment is substantially shorter than what is recommended in clinical guidelines.

More than 20 percent treated three or fewer patients, and fewer than 10 percent treated more than 75 patients. The median treatment duration (53 days) was lower than expected given clinical recommendations of maintenance treatment for up to 12 months and evidence linking longer treatment to better outcomes.

The study – Physician Capacity to Treat Opioid Use Disorder with Buprenorphine‐Assisted Treatment – was conducted by researchers from the RAND Corporation and the University of Pittsburgh School of Medicine and published in the Journal of the American Medical Association (JAMA) September 20, 2016 issue.

The findings suggest that the limited number of experienced prescribers and the limited range of substance use treatment counseling options combine to create major barriers to treatment of more patients.  The researchers recommend options to make medication-assisted treatment more accessible and more consistent with guidelines, such as:

  • A mentoring program for less experienced prescribers, with telephone consultations from more experienced colleagues.
  • Telehealth / web-based counseling options for patients.