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SAMHSA Updates OTP Regulations

SAMHSA Updates OTP Regulations

Updated Feb. 2, 2024

The Substance Abuse and Mental Health Services Administration published Medications for the Treatment of Opioid Use Disorder late yesterday for public inspection. The final rule was published earlier today and becomes effective on April 2, 2024, with compliance by October 2, 2024. [Please note that this is a correction of the compliance date of October 2, 2026 that was published yesterday in the public notice.] NABH provided comments on the Notice of Proposed Rule Making that was issued in December 2022 calling for greater regulatory flexibility for opioid treatment programs (OTPs).

The final regulations align closely to NABH recommendations and herald greater deference to clinical decision-making in the nation’s (OTPs). Among the provisions, the regulations:

  • Make permanent the Covid-era take-home schedule;
  • Permit methadone for new patients via audio-visual telemedicine with the dispensing of medication at the OTP (not audio-only).
  • Permit audio-only telemedicine when the patient is in the presence of a practitioner who is registered to prescribe SII, including dispensing.
  • Clarify (in response to NABH off-line discussion and official comments) that the prescription of methadone to community pharmacies is NOT permitted;
  • Change the requirement for a one-year history of OUD for eligibility so that now either the patient must a) meet diagnostic criteria for moderate-severe OUD, or b) be in OUD remission, or c) at high risk for overdose;
  • Remove the requirement for two treatment failures for people under 18 to be eligible for services;
  • Remove requirement for a one-year history of OUD for people recently released from a correctional facility, pregnant patients, or previously enrolled individuals;
  • Allow medication units to provide all OTP services;
  • Decouple medication and attendance at counseling services;
  • Permit interim treatment for 180 days, including at for-profit OTPs;
  • Permit mid-levels (“…those appropriate licensed by the state”) to prescribe without exemption;
  • Clarified accreditation standards to reduce potential for a burdensome increase in less-than 3-year accreditations;
  • Permit buprenorphine prescribing in an OTP via audio-only and audio-visual without an in-person evaluation; and
  • Update terminology to reflect contemporary, non-stigmatizing language.

The final rule additionally codifies the Consolidated Appropriations Act, 2023 elimination of the Drug Addiction and Treatment Act (DATA) Waiver by removing all relevant language.

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CMS Final Rule Estimates Overall IPF Payments to Increase by 2.3% in 2024

The Centers for Medicare & Medicaid Services (CMS) on Thursday released its Inpatient Psychiatric Facility Prospective Payment System (IPF PPS) final rule for Fiscal Year (FY) 2024, which is estimated to increase overall payments to IPFs by 2.3%, or $70 million, relative to FY 2023.

While the agency’s final FY 2023 payment update is larger than its earlier proposed 1.9% increase, NABH will continue to push policymakers to recognize fully the high costs that our association’s members face.

The FY 2024 update includes increases in the federal per-diem base rate to $895.63 from $865.63, and in the outlier threshold to $33,470 from $24,630, which will reduce the number of cases that qualify for an outlier payment.

CMS released a fact sheet with the final rule. The NABH team is currently reviewing the rule and will share a more detailed summary in tomorrow’s CEO Update.

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HHS, DOL and Treasury Release Proposed Rules to Strengthen MHPAEA

The U.S. Health and Human Services (HHS), Labor (DOL), and Treasury Departments on Tuesday released proposed rules to bolster the Mental Health Parity and Addiction Equity Act (MHPAEA) of 2008 and remove obstacles to behavioral healthcare access.

The rules propose several amendments to the 2013 MHPAEA final regulations, as well as provisions that would establish the content requirements of the Non-Qualitative Treatment Limitations, or NQTL, comparative analyses required under amendments to MHPAEA included in the Consolidated Appropriations Act, 2021 (CAA, 2021).

“Today’s rules show the Biden administration’s continued effort to implement the landmark parity law,” said NABH President and CEO Shawn Coughlin. “We’re hopeful these changes will do much to eliminate the illegal restrictions and barriers to behavioral healthcare that exist today, nearly 15 years after the law passed.”

The three departments also released a Technical Release on NQTLs that outlines principles and seeks public comment to inform future technical guidance about the application of proposed data collection and evaluation requirements to NQTLs related to network composition that the rule proposes.

Along with the proposed rules, the departments released the 2023 MHPAEA Comparative Analysis Report to Congress that the CAA, 2021 requires. The report includes information about the agencies’ enforcement efforts and identifies plans and issuers that received final determinations of non-compliance with MHPAEA.

The White House released a fact sheet about the rule and DOL’s Employee Benefits Security Administration posted all the related documents here.

NABH will seek feedback from members and submit comments about the proposed rules and Technical Release.

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CMS Coverage for PHP Telehealth Services Set to End After May 11

As the COVID-19 Public Health Emergency (PHE) draws to a close at the end of Thursday, May 11, the Centers for Medicare & Medicaid Services (CMS) has shared with NABH and other stakeholders the agency’s plans to end telehealth coverage for partial hospitalization program (PHP) services  implemented during the PHE.

In addition, CMS has explained that telehealth coverage will continue through December 2024 for Intensive Outpatient Program (IOP) services that qualify under the outpatient prospective payment system as “remote mental health services.”

NABH continues to communicate with key Members of Congress to clarify the legislative intent behind the telehealth coverage extensions that were authorized in the Consolidated Appropriations Act, 2023 last December. The NABH team understands that some Members of Congress intended for the telehealth coverage extension to include PHP services.

Given the persistent confusion on these matters, NABH has urged CMS to issue clarification in writing. NABH will keep members apprised of our efforts to extend telehealth coverage for PHP services.  

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FDA Approves First Over-the-Counter Naloxone Spray

The U.S. Food and Drug Administration (FDA) today approved Narcan, 4 mg. naloxone hydrochloride nasal spray for over-the-counter (OTC), non-prescription use, making it the first naloxone product approved to use without a prescription.

Naloxone is a medication that reverses the effects of opioid overdose rapidly and is the standard treatment for opioid overdose. The FDA’s action today clears the way for this life-saving medication to be sold directly to consumers in drug stores, convenience stores, grocery stores, gas stations, and online.

The move comes at a time when the Centers for Disease Control and Prevention released provisional data this month that showed 101,751 reported U.S. fatal overdoses in the 12-month period ending in October 2022, while the predicted number of fatal doses for that period is even higher at 107,689.

“Today’s approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locations where it’s available, and help reduce opioid overdose deaths throughout the country,” FDA Commissioner Robert M. Califf, M.D said in today’s announcement. “We encourage the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”

According to the FDA, the manufacturer determines the timeline for availability and price of this OTC product. Click here to learn more.

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President Biden to Outline Approach for Addressing Nation’s Mental Health & Opioid Crises in State of the Union  

In tonight’s State of the Union address, President Biden is expected to mention specific ways his administration will address America’s mental health crisis, beat its opioid overdose epidemic, and ensure parity.

In a fact sheet about the speech, “mental health” is mentioned 32 times, and “fentanyl” 23 times, signaling the Biden’s administration commitment to tackling two of the nation’s toughest domestic problems. The White House will also discuss these issues in a briefing on Wednesday, Feb. 8 at 2:30 p.m. ET. Click here to register for the webinar.

In a boost for parity, President Biden is expected to say that this administration will propose new rules this spring to ensure that insurance plans do not impose inequitable barriers to care and that mental healthcare providers are being paid by health plans on par with other healthcare professionals.
President Biden is also expected to provide details on how his administration will help expand access to mental healthcare services for all who need it, such as expanding peer support specialists for veterans; creating healthy environments for children, adolescents, and teens; and supporting the nation’s mental healthcare workforce.

The Biden administration also intends to improve the capacity of the 988 lifeline by investing in expanding the nation’s crisis care workforce; scaling mobile intervention services; and developing additional guidance on best practices in crisis response. To enhance telehealth services, HHS will triple resources dedicated to promoting interstate license reciprocity to deliver mental health services across state lines, according to the White House.

Meanwhile, Congress and the nation can expect to hear about this administration’s aggressive plans to combat the nation’s ongoing opioid crisis. News reports Tuesday quoted Office of National Drug Control Policy (ONDCP) Director Rahul Gupta, M.D. as saying President Biden will apply a “forceful approach” for going after fentanyl and expanding public health efforts to reduce overdose deaths. Such measures will include disrupting the trafficking, distribution, and sale of fentanyl. Tonight the president is expected to announce that his administration will add 123 new, large-scale scanners at land points of entry along the nation’s Southwest border by 2026, and also lead a sustained, diplomatic push to address fentanyl and its supply chain abroad.

The president is also supposed to announce a commitment to expanding access to evidence-based prevention, harm reduction, treatment, and recovery. In the last year, the Biden administration has permitted using $50 million for local public health departments to purchase naloxone; released guidance making it easier for programs to obtain and distribute naloxone to at-risk populations; and prioritized reviewing over-the-counter naloxone applications.

President Biden will deliver his State of the Union address at 9 p.m. ET.

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NABH Education and Research Foundation Partners with Manatt to Produce Issue Brief on Telehealth Services in PHP and IOP

NABH is pleased to announce that the NABH Education and Research Foundation today released an issue brief that shows how telehealth services effectively augment traditional partial hospitalization programs (PHP) and intensive outpatient programs (IOP).

The telehealth issue brief is the first resource from the NABH Education and Research Foundation, which worked with NABH members and Manatt to compile and evaluate data to measure the impact that telehealth services have had on access and outcomes.

Results from the study show that using telehealth services improved access to care and optimized the reach of existing personnel. The initial findings from several NABH members also indicated that, relative to in-person services, telehealth delivery-of-care produced similar or better outcomes for PHP and IOP patients.

The telehealth issue brief’s key findings also include:

  • During the COVID-19 crisis, regulatory flexibilities enabled traditional in-person PHPs and IOP programs to implement telehealth services rapidly.
  • Using telehealth to deliver PHP and IOP services has improved access to care for remote patients and those facing other access obstacles.
  • Emerging research is showing that, relative to in-person care, the use of telehealth in PHPs and IOPs generally is improving the quality of clinical care, patient satisfaction and the overall efficiency of the healthcare system.

NABH urges its members to read the issue brief and share it with others. The association has also created a social media toolkit with shareable graphics that highlight key research from the study. Members can access the issue brief and social media toolkit on the NABH Education and Research Foundation’s Resources page.

Manatt will host a webinar about the issue brief’s findings on Wednesday, March 1 at noon ET. Click here to learn more and register for the free webinar.

The NABH Education & Research Foundation fields independent studies and partners with other
organizations to identify and develop best practices and improve NABH members’ ability to support the country’s behavioral health needs.

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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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