Advocacy News
HSAM endorses the Modernizing Opioid Treatment Access Act
HSAM joined the American Society of Addiction Medicine in endorsing S. 644/H.R. 1359 - the Modernizing Opioid Treatment Access Act (M-OTAA). The M-OTAA would allow physicians board-certified in Addiction Medicine or Addiction Psychiatry as well as opioid treatment program clinicians to prescribe methadone for the treatment of opioid use disorders. Under the M-OTAA, patients with methadone prescriptions from these expert providers could pick up methadone from pharmacies instead of going to opioid treatment programs (OTPs), colloquially known as methadone clinics.
Methadone is the most well-studied medication for opioid use disorder and has been in use for decades. It has consistently been shown to decrease opioid overdose deaths, all-cause mortality, HIV and hepatitis C infections, and criminal activity. However there remains a shortage of OTPs which are currently the only means through which patients can access methadone treatment for opioid use disorders. This shortage is particularly pronounced in rural areas. The M-OTAA would break down barriers to this life-saving care by increasing access and also decreasing the stigma associated with methadone treatment.
The text of the Modernizing Opioid Treatment Access Act can be viewed through the House or Senate websites.
May 4, 2023
The End of the X-waiver
In a major step towards combating the ongoing opioid epidemic, the United States Congress has passed the Consolidated Appropriations Act of 2023, which includes the removal of the X-waiver for the prescribing of buprenorphine and the elimination of patient caps.
The X-waiver, also known as the DATA 2000 waiver, is a requirement that healthcare providers obtain a special license before they can prescribe buprenorphine, a medication used to treat opioid addiction. This requirement has been seen as a barrier to accessing treatment, as it limits the number of healthcare providers who are able to prescribe the medication. With the removal of the X-waiver requirement, healthcare providers will no longer need a special license to prescribe buprenorphine. This change is expected to significantly increase access to medication-assisted treatment for opioid addiction, particularly in rural and underserved areas where there may be a shortage of healthcare providers who are authorized to prescribe buprenorphine.
In addition to removing the X-waiver requirement, the Consolidated Appropriations Act also eliminates patient caps on buprenorphine prescriptions. Previously, healthcare providers were limited in the number of patients they could treat with buprenorphine, with the limit increasing over time from 30 patients to 100 patients for qualified healthcare providers. The removal of patient caps means that healthcare providers will now be able to treat as many patients with buprenorphine as they see fit, based on their clinical judgement and capacity to provide appropriate care.
Beginning in June 2023, every DEA registrant will be required to complete a one-time training in Addiction Medicine. Providers board-certified in Addiction Medicine or Addiction Psychiatry are exempt from the training requirement. The Substance Abuse and Mental Health Services Administration website will post more updates regarding the training as it becomes available.
December 30, 2022
Barriers to Buprenorphine Access at Pharmacies Gets National Attention
Across the country patients are encountering barriers to filling their buprenorphine prescriptions. Though no DEA quotas or caps on schedule III medications exist, pharmacies often limit their stock of buprenorphine due to fears of DEA audits. The U.S. House Appropriations Committee has expressed concerns about this trend and is requesting more information. The Labor, Health and Human Services, Education and Related Agencies subcommittee (LHHS) is requesting a briefing from the Centers for Medicare and Medicaid Services (CMS) and the Office of the Inspector General (OIG) examining access to medications for opioid use disorder. The Commerce, Justice, Science, and Related Agencies subcommittee (CJS) is requesting a report on the same issues from the Drug Enforcement Administration (DEA). Hawaii Representative Ed Case sits on the CJS subcommittee and will be hearing the report from the DEA - to share your perspective on buprenorphine access issues you can contact Representative Case here.
ASAM is also collecting data about patients’ difficulties filling their prescriptions for buprenorphine. To add your story, fill out their form at surveymonkey.com/r/ASAMpharmacy.
August 13, 2022
HSAM Joins Petition to Change FDA Labeling for Buprenorphine
HSAM joins the Colorado Society of Addiction Medicine and several other state chapters of the American Society of Addiction Medicine in signing the petition for the FDA to accommodate daily dosing of buprenorphine above 24mg. Buprenorphine has been shown to be safe in high doses due to its action as a partial opioid agonist, and some patients may need higher doses to resolve withdrawal symptoms. Some evidence also suggests that doses higher than 24mg may be associated with higher treatment retention. Capping the recommended dose at 24mg too often results in the unwillingness of insurance companies to provide coverage if a patient requires higher doses to achieve and maintain recovery. Patients are then left with the choice of whether to pay the astronomical out-of-pocket medication costs or accept the risks that come with being under-treated, which may include painful withdrawal or relapse.
The Citizen Petition asks the U.S. Food and Drug Administration to change the buprenorphine labeling to include the following:
“Following initiation, buprenorphine dose should be titrated based on the prescriber’s clinical judgment to alleviate symptoms enough to enable patients to maintain discontinuation of illicit opioid use. Evidence suggests that 16mg per day or more may reduce risk of overdose death more effectively than lower doses. Some patients may require a higher than average dose due to significant inter-patient variability in opioid tolerance, drug absorption, and drug metabolism such as during pregnancy.”
Individuals who wish to lend their support to this effort may sign the petition here by Wednesday, July 27.
July 21, 2022
HSAM applauds the passage of the Restoring Hope for Mental Health and Well-Being Act of 2022 (H.R.7666)
On Wednesday, June 22, the U.S. House of Representatives passed the Restoring Hope for Mental Health and Well-Being Act of 2022 (H.R.7666) with a strong bipartisan majority. HSAM applauds the passage of the bill and its Mainstreaming Addiction Treatment (MAT) Act provision, which will remove federal requirement for an X-waiver to prescribe buprenorphine.
Additional provisions of the bill include:
removal of the requirement for 1 year of opioid dependence before beginning a methadone maintenance program
establishment of new criteria for patients to receive take-home doses of methadone after the COVID-19 public health emergency has ended
reauthorization of the Addiction Medicine Fellowship Program, which offers grants to institutions that provide training for addiction medicine and addiction psychiatry fellows
authorization of funding to promote the collaborative care model and integrate substance use disorder treatment into primary care settings
requirement for federal agencies to promote quality recovery housing for those with substance use disorders
HSAM will continue to follow this bill as it moves on to the Senate.
June 22, 2022