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Government Eliminates Waiver Requirement for Doctors Prescribing the Addiction Treatment Medication Buprenorphine
/in Policy Blogs, Featured News Home Behavioral/Mental Health and SUD, Chronic and Complex Populations, Chronic Disease Prevention and Management, Health Equity, Physical and Behavioral Health Integration, Population Health, Social Determinants of Health /by Jodi Manz and Kitty PuringtonUpdate: On Jan. 27, 2021, the Office of National Drug Control Policy (ONDCP) notified stakeholders that the earlier announcement from the Department of Health and Human Services (HHS) that physicians will no longer have to obtain a federal waiver to prescribe the opioid use disorder treatment buprenorphine to patients – as described in this blog – will not be issued at this time. ONDCP noted that it will continue to work with HHS to “examine ways to increase access to buprenorphine, reduce overdose rates, and save lives.” NASHP will continue to update state policy leaders as these federal actions evolve.
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retract this new guidance, but given the momentum toward removing barriers to OUD treatment, it is not expected to be repealed.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.
States May Soon Have to Provide Medication-Assisted Treatment to Inmates, Here’s How to Fund It
/in Policy Blogs Behavioral/Mental Health and SUD, Care Coordination, Chronic and Complex Populations, Chronic Disease Prevention and Management, Cost, Payment, and Delivery Reform, Eligibility and Enrollment, Health Coverage and Access, Health System Costs, Maternal, Child, and Adolescent Health, Medicaid Managed Care, Medicaid Managed Care, Medicaid Managed Care, Medicaid Managed Care, Physical and Behavioral Health Integration, Population Health /by Kitty Purington and Chris KukkaState policymakers on the frontlines of the opioid epidemic understand that treating justice-involved individuals with opioid use disorder (OUD) offers a critical opportunity to expand access to treatment. While there is strong evidence that medication-assisted treatment (MAT) promotes recovery, saves lives, and reduces re-incarceration, states must surmount significant policy and financial challenges to provide MAT in correctional settings.
Without MAT, 77 percent of inmates with OUD relapse within three months of their release, even if they receive counseling in jail.According to a SAMSHA report, MAT has been found to “reduce criminal activity, arrests, as well as probation revocations and re-incarcerations.”
• A Sacramento County Jail MAT program with 174 inmates found only 31% were arrested for new offenses.
• A study of 370 individuals who completed a MAT program in Middlesex County, MA, found only 19% were rearrested.
• A MAT study of 200 in Louisville, KY, jails found 47% remained arrest-free.
Source: Jail-Based MAT: Promising Practices, Guidelines and Resources, National Commission on Correctional Health Care and the National Sheriffs’ Association
A recent federal court decision indicates that states may need to take a close look at how to overcome barriers to expand access to FDA-approved MAT — methadone, buprenorphine, and naltrexone — in jails. In that decision – which could have nationwide implications – the court ruled that preventing access to MAT is a violation of the Americans with Disabilities Act and the 8th Amendment.
A growing number of state legislatures and governors, through executive orders, have mandated MAT in their correctional facilities. Last month, Maryland passed legislation that requires facilities to assess inmates’ substance use status, treat those with OUD with MAT, and provide follow-up treatment and care coordination after release.
Erek L. Barron, a member of Maryland’s General Assembly and a cosponsor of the new law, suggests the treatment could eventually pay for itself in avoided costs from reduced incarceration rates. “States need to understand that there is a high return on investment in MAT,” he told NASHP. “Addressing this high-risk population will enhance states’ response to the opioid crisis and crimes by reducing overdoses and recidivism rates. The key is understanding that substance abuse is a health care problem, not a crime problem.”
Initially, Maryland’s new treatment requirement will be phased into correctional facilities. The program begins in four counties and will cover the entire state and the Baltimore Pre-trial Complex within two years. The screening and treatment program is funded by the state’s initial allocation of $2 million. A report on the initiative’s impact on recidivism, treatment uptake, and crime will be submitted annually to the state’s General Assembly so lawmakers can assess MAT’s impact and its return on investment.
Barron and bill supporters faced challenges from the state’s various political subdivisions that ran local jails and the state prison system, so they took a “health-focused” approach when negotiating with correctional officials. “My primary partners were the county and local health officers,” he explained, “There was also media attention that helped educate the public about this gap in our response to the opioid crisis. I also learned that states are getting substantial amounts of federal funding from the State Opioid Response Grants that can be directed towards MAT in correction facilities.”
But funding MAT implementation in county and state facilities and after inmates are released remains a challenge for many states, particularly in states that did not expand Medicaid, according to states working with the National Academy for State Health Policy (NASHP) and reports from the Substance Abuse and Mental Health Services Administration (SAMHSA), the National Commission on Correctional Health Care, and the National Sheriffs’ Association.
To start or sustain MAT during incarceration and after, states may want to consider the following strategies:
- Tap state block grants and the federal grant funds recently allocated to states for OUD and substance abuse disorder (SUD) treatment by the SUPPORT for Patients and Communities Act and other federal programs.
- Encourage criminal justice agencies to participate in group purchasing organizations in order to negotiate more affordable rates for MAT medications on their formulary. (Read Cross-Agency Strategies to Curb Health Care Costs: Leveraging State Purchasing Power for more information.)
- Medicaid agencies that do not provide coverage for all three medications approved for MAT may consider including them on their formularies.
- States can consider the use of Medicaid options and funding vehicles – such as 1115 waivers – to cover reentry support services, peer services, outreach services, and wraparound case management services for people with opioid use disorders.
- Review Medicaid suspension/termination rules. These rules may present barriers for individuals to re-activate their Medicaid coverage and obtain MAT following release from jail. Read NASHP’s report, Opportunities for Enrolling Justice-Involved Individuals in Medicaid.
- Despite the passage of the Mental Health Parity and Addiction Equity Act of 2008, the essential health benefits of many health plans do not cover OUD/SUD treatments the same way that other chronic diseases are covered. Oversight of private insurance plans can help to ensure coverage of MAT so that individuals reentering the community from jail or prison can access medication in a timely manner.
- To obtain lower-cost drugs, agencies can also participate in the federal 340B Drug Discount Program, which allows certain entities that serve large numbers of uninsured patients to obtain drugs from pharmaceutical suppliers at the same discounted rates that Medicaid pays (about 25 to 50 percent less).
In the months ahead, NASHP will be publishing additional reports detailing effective strategies that states are employing to address the opioid epidemic.
Congress Passes CARA, States to Strengthen Infrastructure and Provider Capacity to Address Opioid Abuse
/in Policy Blogs Behavioral/Mental Health and SUD, Care Coordination, Chronic and Complex Populations, Physical and Behavioral Health Integration /by Charles TownleyCongress passed the final version of the Comprehensive Addiction and Recovery Act of 2016 (CARA) on July 13. Major provisions within CARA will expand access to overdose rescue medication (naloxone) and medication-assisted treatment of opioid use disorders.
CARA authorizes or reauthorizes a number of grant programs for states to build infrastructure and provider capacity to address opioid abuse. Some of the notable grant programs for states, communities, and opioid treatment providers include:
Prevention and Reducing Diversion
- Community-Based Coalition Enhancement Grants to Address Local Drug Crises from the Office of National Drug Control Policy ($5 million annually authorized for FY17-FY21)
- Grants for Establishing, Improving, or Maintaining State Prescription Drug Monitoring Programs ($10 million annually authorized for FY17-FY21)
Overdose Prevention
- Opioid Overdose Reversal Medication Access and Educations Grants for states to implement policies to expand access to naloxone ($5 million total authorized for FY17-FY19)
- First Responder Training Technical Assistance Grants for state and local governments ($12 million annually authorized for FY17-FY21)
Substance Use Disorder Treatment
- Grants to Expand Access to Treatment Interventions for states and local governments ($25 million annually authorized for FY17-FY21)
- Grants for Reducing Overdose Deaths for federally-qualified health centers and opioid treatment programs, and other entities as appropriate ($5 million annually authorized for FY17-FY21)
- Matching Grants to Build Communities of Recovery for eligible non-profit organizations to develop, expand, and enhance community and statewide recovery support services ($1 million annually authorized for FY17-21)
Alternatives to Incarceration
- Comprehensive Opioid Abuse Grant Program from the Attorney General for state and local governments to develop, implement or expand judicial diversion treatment programs ($103 million annually authorized for FY17-21)
CARA also makes significant changes to federal policies that will ultimately increase states’ capacity to provide medication-assisted treatment. Under current law, providers waivered to prescribe and dispense buprenorphine are limited to treating up to 30 patients in the first year and up to 100 thereafter. While the final bill did not directly raise the cap, it granted new authority for the Secretary of Health and Human Services to exclude individuals who are directly administered the medication in the office setting from the limit (i.e., pending approval, the cap may only apply for individuals who receive take-home medication). Furthermore, a clause allowing the Secretary to raise the limit through regulations remains. CARA also extended prescribing and dispensing authority to nurse practitioners and physicians assistants licensed under state law.
The full text of the final language can be found here. A summary is also available. A statement released by the Office of the Press Secretary confirmed that President Obama will sign the bill.
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