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SAMHSA Proposed Rule Permits Methadone Prescribing for New Patients via Telemedicine

The Substance Abuse and Mental Health Services Administration (SAMHSA) on Tuesday proposed updating federal regulations to permit using audio-visual telehealth services for any new patient treated with methadone in an Opioid Treatment Program (OTP) under specific conditions.

In a proposed rule, SAMHSA said federal regulations should be updated to allow using audio-visual telehealth services for patients treated with methadone in OTPs only if a program physician, or an authorized healthcare professional under the supervision of a program physician, determines that an adequate evaluation of the patient can be accomplished via an audio-visual telehealth platform.

This change is not extended to using audio-only telehealth platforms and applies only to ordering methadone that an OTP dispenses under existing OTP procedures.

In addition, SAMHSA’s proposed changes would update 42 CFR Part 8 by removing stigmatizing or outdated language; supporting a more patient-centered approach to treatment; and reducing barriers to receiving care.

SAMHSA’s proposed changes also would revise standards to reflect an OTP accreditation and treatment environment that has evolved since Part 8 became effective in 2001. Consequently, SAMHSA said its proposed revisions reflect evidence-based practice, language that aligns with current medical terminology, effective patient engagement approaches, and the workforce providing services in OTPs, including:

  • expanding the definition of an OTP treatment practitioner to include any provider who is appropriately licensed to dispense and/or prescribe approved medications. The current Part 8 rule defines a practitioner as being: “a physician who is appropriately licensed by the State to dispense covered medications and who possesses a waiver under 21 U.S.C.823(g)(2).” During the Covid-19 public health emergency, this has been formally expanded to align with broader definitions of a practitioner (nurse practitioners, physician assistants, etc.), and OTPs reported that this change was essential in supporting workflow and access;
  • adding evidence-based delivery models of care, such as split dosing, telehealth, and harm-reduction activities;
  • removing such outdated terms as “detoxification”;
  • updating criteria for provision of take-home doses of methadone;
  • strengthening the patient-practitioner relationship through promoting shared and evidence-based decision-making;
  • allowing for early access to take-home doses of methadone for all patients, to promote flexibility in creating plans of care that facilitate such every-day needs as employment, while also affording people with unstable access to reliable transportation the opportunity to also receive treatment; likewise, promoting mobile medication units to expand an OTPs geographic reach; and
  • reviewing OTP accreditation standards.

According to SAMHSA, the changes– which are part of President Biden’s National Drug Control Strategy – come at a time when fewer than one out of 10 Americans can access treatment for substance use disorder.

SAMHSA will accept public comments on the proposed rule until Feb. 14, 2023.

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Biden Administration Launches Opioid Overdose Dashboard

The Biden Administration on Thursday unveiled a new website featuring the Office of National Drug Control Policy’s (ONDCP) new Opioid Overdose Tracker to track non-fatal, opioid overdoses in the pre-hospital setting in an effort to prevent overdose deaths.

Non-fatal overdoses are a good predictor of fatal overdoses, Biden administration officials said during a news briefing Wednesday according to Politico. People who experience at least one non-fatal overdose are about two to three times more likely to eventually die from one, they said.

Using data submitted to the National Emergency Medical Services Information System (NEMSIS), the new dashboard contains one interactive page with a geo-surveillance view, and its data set includes all de-duplicated Emergency Medical Services (EMS) patient care reports for a rolling time period that meet specific inclusion criteria.

In 2022, all 50 states, three territories (the Virgin Islands, Guam, and the Northern Mariana Islands), and Washington, D.C. had submitted data to the national database, according to NEMSIS. The NEMSIS Technical Assistance Center collects data from about 95% of all EMS agencies in the United States that respond to 911 requests for emergency care and transport patients to acute care facilities.

Earlier this year, the Centers for Disease Control and Prevention estimated that 80,816 Americans died from opioid overdoses in 2021, increasing from an estimated 70,029 in 2020.

According to a National Public Radio story, ONDCP Director Rahul Gupta, M.D. told reporters during a call that “We could see tens of thousands of additional lives saved” with the new tool, which Gupta said he hopes first responders, clinicians, and policymakers will use to connect people to care and also minimize response times and ensure that resources are available.

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NABH’s Enhanced Denial-of-Care Portal is Now Available!

The National Association for Behavioral Healthcare is pleased to announce enhancements to its Denial-of-Care Portal that are intended to make the portal easier for members to use.

A year ago, NABH developed the Denial-of-Care Portal to collect specific data on insurers who deny care—often without regard to parity or the effects on patients. Now the association has updated this resource to make it more user-friendly for members and also more aligned with what regulators need to identify parity violations.

The updated portal includes fewer questions, which will require less time for members to complete. In addition, all questions are now optional. NABH hopes this will make it more likely for members to share the data they have. Lastly, NABH has added a checklist of “red flags” that were included in the 2022 MHPAEA Report to Congress from the U.S. Health and Human Services, Labor, and Treasury Departments in January.

“We know the best way to advocate for parity enforcement with regulators is to provide hard data from our members that show how insurers are not complying with the landmark 2008 parity law,” said NABH President and CEO Shawn Coughlin. “We hope these new changes will make it easier—and faster—for our members to use so that we can gather that critical data.”

Please e-mail Emily Wilkins, NABH’s administrative coordinator, if you have questions.

As always, thank you for all you do each day to support and advance NABH’s mission and vision!

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ONDCP Releases Plan to Reduce Methamphetamine Supply and Save Lives

The White House Office of National Drug Control Policy (ONDCP) on Monday released the Biden administration’s plan to reduce the supply of methamphetamine and save lives as meth-related overdose deaths are rising in the United States.

Designed to reduce meth use and prevent meth-involved overdoses, the 25-page plan is also intended to expand access to evidence-based treatment and reduce the trafficking and supply of meth.

“The tragic rise in methamphetamine-involved overdose deaths requires immediate action,” ONDCP Director Rahul Gupta, M.D., M.P.H., M.B.A., FACP said in his agency’s announcement. “This bold, new action plan builds on the president’s National Drug Control Strategy by expanding access to evidence-based prevention, treatment, and harm reduction strategies, as well as reducing the supply of methamphetamine and other illicit drugs by going after drug trafficking organizations,” Dr. Gupta continued. “This comprehensive and forward-looking action plan will help make our communities healthier and safer.”

The plan applies a public health and safety approach that emphasizes treatment services, harm-reduction services, prevention in schools nationwide, training and education, domestic law enforcement coordination, federal oversight of pill press equipment, international partnerships to disrupt trafficking, and expanded training for domestic and international law enforcement agencies involved in disrupting meth distribution.

NABH participates in the Motivational Incentives Policy Workgroup that has met with ONDCP about broadly implementing the evidence-based treatment practice of contingency management, which the new plan highlights.

You can learn more about the Biden administration’s National Drug Control Strategy at the NABH 2022 Annual Meeting, when Dr. Gupta will address attendees on Tuesday, June 14 at 9:30 a.m. ET in the Grand Ballroom at the Mandarin Oriental Washington, DC.

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President Biden Sends National Drug Control Policy to Congress

President Biden on Thursday sent his administration’s inaugural National Drug Control Policy to Congress with the goal of using a whole-of-government approach to combat the nation’s overdose crisis.

The comprehensive strategy focuses on the main drivers of the crisis—untreated addiction and drug trafficking—as it directs federal agencies to take actions that will expand access to evidence-based prevention, harm reduction, treatment, and recovery services, while also reducing the supply of drugs.

The plan comes as the nation continues to produce grim statistics: for the first time in America’s history, the country has passed the milestone of 100,000 deaths resulting from drug overdoses in a 12-month period. Meanwhile, since 1999, drug overdoses have killed approximately 1 million Americans.

A message from President Bident to Congress at the beginning of the strategy explains the Office of National Drug Control Policy led the effort to produce the strategy in close collaboration with the 18 national drug control agencies. In addition, the Biden administration involved more than 2,000 leaders and stakeholders, including Congress, all 50 Governors, and advocates representing public safety, public health, community groups, local governments, and Tribal communities.

An important component of the strategy is its emphasis on harm reduction, an approach that works with people who use drugs to prevent overdose and infectious disease transmission; improve the physical, mental, and social wellbeing of those served; and offer flexible options for accessing substance use disorder treatment and other health care services.

“We are changing how we help people when it comes to drug use, by meeting them where they are with high-impact harm reduction services and removing barriers to effective treatment for addiction,” Rahul Gupta, M.D., M.P.H., M.B.A., director of National Drug Control Policy, said in the document, “while addressing the underlying factors that lead to substance use disorder head on.”

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President Biden’s First State of the Union to Include Strategy to Address U.S. Mental Health Crisis

President Biden is expected to announce his administration’s strategy to address the nation’s mental health crisis in the president’s first State of the Union tonight, according to a White House announcement.

The strategy is part of what the White House has called a “unity agenda” that consists of policy in which there has historically been support from both Democrats and Republicans—and for which the president will call on Congress to send bills to his desk that deliver progress for all Americans.

According to the administration, the mental health strategy aims to strengthen system capacity, connect more Americans to care, and create healthy environments where the country’s health and social services infrastructure addresses mental health holistically and equitably.

A White House fact sheet provides detailed action steps for each of these three goals, such as launching the 988 behavioral health crisis hotline that will go live in July; expanding and strengthening parity; and establishing stronger online protections for young people, including prioritizing safety-by-design standards and practices for online platforms, products, and services.

President Biden will deliver the State of the Union at 9 p.m. ET. The address will air on all major broadcast networks and cable news channels.

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SAMHSA Extends Take-Home Methadone Flexibilities to OTPS for One Year

The Substance Abuse and Mental Health Services Administration (SAMHSA) on Thursday said it will extend for one year the methadone take-home flexibilities it provided to opioid treatment programs (OTPs) at the start of the Covid-19 pandemic in March 2020 and is “considering mechanisms to make this flexibility permanent.”

This flexibility has allowed OTPs to dispense 28 days of take-home methadone doses for stable patients and up to 14 days of take-home methadone medication to less stable patients, based on provider assessments.

SAMHSA’s announcement said it is extending the flexibilities for a year “effective upon the eventual expiration of the Covid-19 Public Health Emergency.”

Click here to read SAMHSA’s announcement.

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CMS Proposes Audio-Only Communication for Telehealth to Treat Mental Health and Substance Use Disorders

In its Medicare physician fee schedule proposed rule for 2022, the Centers for Medicare & Medicaid Services (CMS) has proposed extending Medicare coverage to audio-only communication technology for telehealth services to diagnose, evaluate, or treat established patients with mental health disorders and providing Medicare coverage for telemental health services for beneficiaries who are in their homes for appointments.

CMS has proposed limiting the use of an audio-only interactive telecommunications system for mental health services for cases in which practitioners have the capability to provide two-way, audio/video communications, but the beneficiary is not capable of using, or does not consent to using, two-way, audio/video technology. CMS has also proposed requiring a new modifier for services provided using audio-only communications that would certify that the practitioner had the capability to provide two-way, audio/video technology, but instead used audio-only technology due to beneficiary choice or limitations.

In addition, CMS has proposed allowing certain services added to the Medicare telehealth list to remain on the list until Dec. 31, 2023 to create a glide path to evaluate whether the services should be added permanently to this list after the Covid-19 public health emergency (PHE) ends.

CMS is also seeking comment on these proposed recommendations: (1) whether additional documentation should be required in the patient’s medical record to support the clinical appropriateness of audio-only telehealth; (2) whether or not the agency should preclude audio-only telehealth for some high-level services, such as level 4 or 5 E/M visit codes or psychotherapy with crisis; and (3) if there are other “guardrails” the agency should establish to minimize concerns about program integrity and patient safety.

The agency also proposed implementing recently enacted legislation that removes statutory restrictions to provide Medicare coverage of telehealth services for mental health disorders for beneficiaries in any geographic location and in their homes. CMS recommends requiring that an in-person, non-telehealth service be provided by the physician or practitioner furnishing mental health telehealth services within six months prior to the initial telehealth service, and at least once every six months thereafter.

CMS is seeking comment on whether a different interval may be necessary or appropriate for mental health services furnished through audio-only communication technology. The agency is also seeking comment on how to address scenarios where a physician or practitioner of the same specialty/subspecialty in the same group may need to provide a mental health service due to unavailability of the beneficiary’s regular practitioner.

For opioid treatment programs (OTPs), the proposed rule recommends allowing OTPs to provide counseling and therapy services via audio-only interaction (such as telephone calls) after the Covid-19 PHE ends in cases where audio/video communication is not available to the beneficiary, including circumstances in which the beneficiary is not capable of, or does not consent to using, devices that permit a two-way audio/video interaction, provided all other applicable requirements are met.

CMS has proposed requiring that OTPs use a service-level modifier for audio-only services billed using the counseling and therapy add-on code (not bundled services) and document in the medical record the rationale for a service provided using audio-only services, in order to facilitate program-integrity activities.

CMS also proposed coverage for the newly approved, higher dose naloxone hydrochloride nasal spray product, and is delaying compliance with electronic prescribing of controlled substances (EPCS) from January 2022 to January 2023.

Click here for more information about the proposed rule, which will be published in the Federal Register on July 23. CMS will accept comments on the rule until 5 p.m. ET on Monday, Sept. 13, 2021.

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Biden to Nominate Former West Va. Health Official Rahul Gupta as Drug Czar

President Biden is expected to nominate Rahul Gupta, M.D. M.PH., M.B.A. to serve as director of the Office of National Drug Control Policy (ONDCP), according to multiple news outlets.

If confirmed, Gupta, a buprenorphine-waivered physician, will be the first physician to serve as the office’s director. Most recently Gupta served as senior vice president and chief medical and health officer at the March of Dimes. Previously he served as West Virginia’s health commissioner and is known to be an ally of Sen. Joe Manchin (D-W.Va.).

NABH has learned that harm-reduction advocates do not support Gupta’s nomination because of their concerns about how he managed an HIV outbreak in West Virginia, citing a lack of support for needle exchanges, an evidence-based practice that reduces HIV, viral hepatitis, and other infections. ONDCP’s drug policy priorities published in April 2021 have strong harm-reduction priorities, including funding support syringe exchange programs and amplifying best practices for fentanyl test strips.

Gupta has been a frontrunner for the position, along with Regina LaBelle, currently ONDCP’s acting director who took a leave of absence from her role as a distinguished scholar and program director at the Addiction and Public Policy Initiative at Georgetown University’s O’Neill Institute.

NABH coordinated a stakeholder letter to the Biden Administration that requested the president appoint an ONDCP director to address the highest rates of opioid overdose deaths ever recorded, stating that the pandemic exacerbated what was already an inadequate level of treatment for people with a substance use disorder in the United States.

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The NABH Denial-of-Care Portal is Now Live!

The National Association for Behavioral Healthcare is pleased to introduce the NABH Denial-of-Care Portal, a resource for members to provide information about their experiences with managed care organizations that impose barriers to care through insurance-claim denials.

NABH’s Managed Care Committee has worked for more than a year to develop the Denial-of-Care Portal as a way to collect specific data on insurers who deny care—often without regard to parity or the effects on patients.

This NABH member-only, survey-like tool allows users to add the name of a managed care organization, type of plan, level of care, type of care (mental health or substance use disorder), duration of approved treatment, duration of unapproved treatment, criteria used to deny a claim, and more.

The portal allows members to submit individual examples of claim denials or upload multiple entries via Excel. It also includes sections on appeals and physician participation. In time, the tool could be a valuable resource for the NABH team’s advocacy efforts.

“One of the best ways we can advocate for parity enforcement with policymakers and regulators is to provide hard data from our members that show how insurers are not complying with the landmark 2008 parity law,” said NABH President and CEO Shawn Coughlin. “We hope to gather this critical data through our new Denial-of-Care Portal.”

Please e-mail Emily Wilkins, NABH’s administrative coordinator, if you have questions.

As always, thank you for all you do each day to support and advance NABH’s mission and vision!

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