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 In addition, SAMHSA’s proposed changes would update 42 CFR Part 8 by removing stigmatizing or outdated language; supporting a more patient-centered approach to treatment; and reducing barriers to receiving care.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  • removing such outdated terms as “detoxification”;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

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.

Rochelle Archuleta Joins NABH as Executive Vice President for Government Relations and Public Policy

Rochelle Archuleta has joined the National Association for Behavioral Healthcare (NABH) as executive vice president for government relations and public policy, effective Sept. 6. Rochelle brings to NABH 30 years of experience in the health policy, healthcare delivery system, and legislative arenas. During her 20-year tenure as a policy director for the American Hospital Association (AHA), Rochelle led AHA’s post-acute care policy team. In this role, Rochelle partnered with providers, policymakers, and leading trade associations on issues pertaining to the home health, skilled nursing facility/nursing home, inpatient rehabilitation facility, and long-term care hospital sectors. These advocacy efforts expanded to include issues of common concern to all post-acute care providers and their hospital partners, including issues pertaining to Medicare Advantage and commercial insurers, as well as the Medicare program’s effort to create a new, unified payment system to reimburse the aforementioned, post-acute care settings. “We are pleased to welcome Rochelle to our team,” said Shawn Coughlin, president and CEO at NABH. “Rochelle’s extensive work in healthcare policy, as well as her strong relationships with partner associations, will enhance NABH’s advocacy efforts—both with legislators and regulators.” Rochelle is a research fellow in the Georgetown University McCourt School of Public Policy and is a former David Winston Health Policy Fellow. She earned a master of science in health administration and a master of business administration from the University of Alabama at Birmingham School of Health Professions and a bachelor of arts in political science from the University of Colorado at Boulder.

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!

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.

President Biden Sends National Drug Control Policy to Congress

[vc_row][vc_column][vc_column_text]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.”[/vc_column_text][/vc_column][/vc_row]

President Biden’s 2023 Budget Seeks to Transform U.S. Behavioral Healthcare Delivery

[vc_row][vc_column][vc_column_text]President Biden is proposing new, mandatory investments totaling $51.7 billion over 10 years to enhance behavioral healthcare in America in the fiscal year (FY) 2023 budget proposal he released Monday. Among the budget blueprint’s most notable behavioral health provisions is the president’s request of $697 million for the Substance Abuse and Mental Health Services Administration (SAMHSA) to ensure that 100% of contacts are answered for the new 988 behavioral health crisis hotline that will begin to operate in July. This is an increase of $590 million from what was enacted for fiscal year 2022. Another significant provision is the president’s proposal for a new, $7.5 billion Mental Health System Transformation Fund through Medicaid to increase access to mental health services through workforce development and service expansion, including the development of non-traditional health delivery sites, the integration of quality mental health and substance use care into primary care settings, and the dissemination of evidence-based practices. President Biden’s budget also provides an investment of $397 million for the Health Resources and Services Administration’s (HRSA) Behavioral Health Workforce Development Programs, which is $235 million above FY 2022 enacted level. This funding is intended to increase training of new behavioral healthcare providers, including a track for health support workers such as peers and community health workers. The program also places an emphasis on team-based care. This investment is meant to promote inclusive and equitable behavioral healthcare for youth and focus on the knowledge and understanding of children, adolescents, and youth at risk for a mental health disorder, serious emotional disturbance, or substance use disorder (SUD). The budget also includes increases in primary care training and enhancement and nurse education, practice, and retention to expand behavioral health services into primary care. The FY 2023 budget provides $4.6 billion for SAMHSA’s mental health activities, an increase of $2.5 billion above the FY 2022 enacted level. These investments would provide a historic investment in the Behavior Health Crisis Services; expand access to crisis services; ensure access to early intervention and prevention services to the nation’s vulnerable populations; and invest in children’s mental health. NABH is pleased to see President Biden’s budget calls for improving compliance with behavioral health parity standards by requiring plans and issuers to use medical necessity criteria for behavioral health services that are consistent with the criteria developed by not-for-profit medical specialty associations. The proposal would also place limits on the consideration of profit in determinations of medical necessity. The budget would authorize the secretaries of the U.S. Health and Human Services, Labor, and Treasury Departments to regulate behavioral health network adequacy, and to issue regulations on a standard for parity in reimbursement rates based on the results of comparative analyses submitted by plans and issuers at a cost of $720 million over 10 years. The budget proposes requiring all plans and issuers to cover three behavioral health visits and three primary care visits each year without charging a copayment, co-insurance or deductible-related fee.  And it would provide $125 million in mandatory funding over five years for grants to states to enforce mental health and SUD parity requirements.  Any funds not expended by states at the end of five fiscal years would remain available to the HHS secretary to make additional mental health parity grants. It also proposes to eliminate the ability of self-insured non-federal governmental plans to opt out of parity, affording state and municipal employees the same consumer protections that apply to other employees with private health insurance. In Medicare, the president’s budget would eliminate the 190-day lifetime limit and would require Medicare to cover up to three behavioral health visits per year without cost-sharing. Also related to the Medicare program, current law requires the Centers for Medicare & Medicaid Services (CMS) to terminate psychiatric hospital participation in Medicare after six months of non-compliance with conditions of participation, even if the deficiency does not jeopardize patient health and wellbeing.  This provision does not apply to any other provider category. The president’s proposal would give CMS flexibility to allow a psychiatric hospital to continue receiving Medicare payments when deficiencies are not considered to immediately jeopardize the health and safety of its patients and where the facility is actively working to correct the deficiencies identified in an approved Plan of Correction.  This provision is considered budget-neutral and would not have cost implications. Among other provisions, the White House budget proposal would also establish a Medicare benefit category for licensed professional counselors and marriage and family therapists that authorizes direct billing and payment under Medicare for these practitioners; remove limits on the scope of services for which Medicare can pay clinical social workers, licensed professional counselors, and marriage and family therapists; and allow these practitioners to bill Medicare directly for their mental health services for covered Part A qualifying Skilled Nursing Facility stays. And the proposal would ensure that mental health and SUD benefits under Medicare do not face greater limitations on reimbursement or access to care relative to medical and surgical benefits.  The Medicare Payment Advisory Commission (MedPAC) would be required to issue a report to identify existing gaps in mental health and substance use disorder benefits to be addressed in the Medicare statute. Specifically for SUD, President Biden has proposed $519 million, more than double the 2022 enacted level, for the Family Violence Prevention and Services program. This is the primary federal funding stream dedicated to the support of emergency shelter and related assistance for victims of domestic violence and their children. The funding represents an increase of $292 million over FY 2022 enacted for the base program’s shelters and supportive services. This funding provides services to an estimated 1.3 million children and families to prevent family violence, domestic violence, and dating violence. This includes $250 million in cash assistance for domestic violence survivors and $30 million for the Safe Recovery Together demonstration grants. The demonstration grants will support families affected by domestic violence at the intersection of substance-use coercion, housing instability, and child welfare involvement. President Biden’s FY 2023 budget also proposes:
  • $413 million to SAMHSA in FY 2023, and $4.1 billion over 10 years, for community health centers
  • A $238 million increase above the FY 2022 enacted level in funding for Certified Community Behavioral Health Center Expansion Grants
  • An increase in the amount of Mental Health Block Grant funds reserved for crisis intervention services to 10% from 5%
  • An investment of $11.4 billion, including $10.8 billion in discretionary funding, in programs addressing opioids and overdose-related activities across HHS.
After President Biden kicked off the federal budget process on Monday with his budget proposal, Office of Management and Budget Director Shalanda Young testified Tuesday before the House Budget Committee. Director Young will take more questions from the Senate Budget Committee on Wednesday. Meanwhile, congressional appropriators will begin their work soon, starting with a House Appropriations Committee hearing this Thursday that will feature U.S. Health and Human Services Department (HHS) Secretary Xavier Becerra.[/vc_column_text][/vc_column][/vc_row]

NABH Issue Brief: Details About 9th U.S. Circuit Court of Appeals Ruling to Overturn Wit v. United Behavioral Health Decision

[vc_row][vc_column][vc_column_text]In a blow to parity this week, a three-judge panel of the 9th U.S. Circuit Court of Appeals overturned a trial court’s Wit v. United Behavioral Health (UBH) decision, asserting that UBH’s interpretation that health insurance plans do not require consistency with generally accepted standards of care (GASC) “was not unreasonable.” This NABH Issue Brief highlights brief background on the earlier decision from the trial court, as well as the main points of the three-judge panel’s reversal of that decision this week in its seven-page ruling:
  • The original Wit decision determined that patients’ health and safety are protected when clinicians provide services consistent with GASC that are established by not-for-profit, professional associations, rather than insurance companies whose financial incentives often conflict with what is best for patients.
  • The three-judge panel said it is “not unreasonable” for health insurers’ coverage determinations to be inconsistent with GASC; however, the trial court’s decision, including two 100-page decisions, described how UBH made medical coverage decisions based on financial interests.
  • In its ruling, the appellate court’s three-judge panel did not cite one holding or one fact that the trial court concluded, despite the trial court’s exhaustive trial findings.
  • The trial court’s decision explained UBH’s misrepresentation to regulators that UBH used American Society of Addiction Medicine (ASAM) criteria when, in fact, the company modified and ultimately undercut the actual ASAM criteria.
  • The appellate court’s three-judge panel ruled that UBH is not obligated to cover treatment consistent with GASC if the treatment is not a covered benefit; however, the plaintiffs did not argue that UBH was obligated to cover all services consistent with GASC. Instead, the plaintiffs argued that if services—such as outpatient, intensive outpatient, and residential treatment—are covered benefits, UBH must make medical necessity determinations that are consistent with GASC.
The deeply flawed ruling from the three-judge panel of the 9th U.S. Circuit Court of Appeals has the potential for worsening America’s mental health and addiction crises as the critical need for mental health and addiction treatment services continues to rise during the ongoing Covid-19 pandemic. NABH will continue to fight for true mental health addiction treatment parity and expanded access to care for all who need it.[/vc_column_text][/vc_column][/vc_row]

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

[vc_row][vc_column][vc_column_text]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.[/vc_column_text][/vc_column][/vc_row]

CMS Issues Guidance on Covid-19 Vaccination Requirements for Most Medicare- and Medicaid-Certified Providers

[vc_row][vc_column][vc_column_text]The Centers for Medicare & Medicaid Services (CMS) on Dec. 29 issued guidance regarding the Interim Final Rule (IFR) regarding Covid-19 vaccination requirements for healthcare staff that the agency published in early November. In the Dec, 29 memo, CMS specified that this guidance does not apply to the following states that are still subject to preliminary injunctions that federal courts issued to block implementation of the IFR in those states: Alabama, Alaska, Arizona, Arkansas, Georgia, Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Montana, Nebraska, New Hampshire, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Texas, Utah, West Virginia, and Wyoming. The new CMS guidance delineates the following deadlines and clarifications for requirements that most Medicare- and Medicaid-certified providers must meet in all other states: Within 30 days after issuance of the guidance, healthcare facilities must:
  • Have policies and procedures developed and implemented to ensure all facility staff are vaccinated; and
  • 100% of staff have received at least one dose of Covid-19 vaccine, or have requested an exemption due to a disability or sincerely held religious beliefs, or must wait to receive the vaccine as the Centers for Disease Control and Prevention (CDC) recommends.
  • Facilities that fail to meet this requirement will receive notice of non-compliance, but those that are above 80% and have a plan to achieve 100% staff vaccination within 60 days will not be subject to additional enforcement action.
Within 60 days after the guidance has been issued, healthcare facilities must:
  • Have policies and procedures developed and implemented to ensure all facility staff are vaccinated; and
  • 100% of staff have received completed vaccine series or been granted an exemption due to a disability, or sincerely held religious beliefs, or must wait to receive the vaccine as the CDC recommends.
  • Facilities that fail to meet this requirement will receive notice of their non-compliance, but those that are above 90% and have a plan to achieve 100% staff vaccination within 30 days will not be subject to additional enforcement action.
Within 90 days of issuance of the guidance, facilities failing to maintain compliance with the 100% standard may be subject to enforcement action. CMS also issued specific guidance for each healthcare facility type subject to the IFR, including hospitals and psychiatric residential treatment facilities (PRTFs). The guidance for hospitals and PRTFs appears to be the same. These more specific guidance documents note that “the requirements described above do not include the 14-day waiting period as identified by CDC for full vaccination. Rather, these requirements are considered met with the completed vaccine series (i.e., one dose of a single dose vaccine, or final dose of a multi-dose vaccine series).” This guidance specifies that hospitals and PRTFs “must have a process for ensuring all staff have received at least a single-dose, or the first dose of a multi-dose Covid-19 vaccine series prior to providing any care, treatment, or other services for the facility and/or its patients.” Hospitals and PRTFs “must also ensure those staff who are not yet fully vaccinated . . . adhere to additional precautions that are intended to mitigate the spread of Covid-19.” The guidance suggests a variety of actions or job modifications a facility can implement, including reassigning staff to remote work, mandatory routine Covid-19 testing in accordance with Occupational Safety and Health Administration (OSHA) and CDC guidelines, and requiring staff to wear N95 or higher-level respirators. CMS suggests similar actions for unvaccinated staff who are exempt from the vaccination requirements. The guidance for hospitals and PRTFs clarifies that “[s]taff who exclusively provide telehealth or telemedicine services outside of the hospital setting” and “[s]taff who provide support services for the hospital that are preformed exclusively outside of the hospital setting” are exempt from the vaccination requirements. The guidance also notes, however, “that these individuals may be subject to other federal requirements for Covid-19 vaccination.” In addition, the guidance notes that hospitals and PRTFs are not required to ensure that “one-off” vendors, volunteers, and professionals that provide infrequent, ad hoc, non-healthcare services (such as annual elevator inspections) are vaccinated. Hospitals and PRTFs must track and securely document the following information:
  • Each staff member’s (including contractors, volunteers, and students) vaccination status including specific vaccine, date of each dose, and date of next scheduled dose as well as each staff’s role, assigned work area, and how they interact with patients;
  • Staff who have obtained any booster doses (including specific vaccine and date);
  • Staff granted an exemption (including type of exemption and supporting documentation including documentation signed and dated by a licensed practitioner for medical exemptions);
  • Staff for whom vaccination must be temporarily delayed (including date when staff can safely be vaccinated); and
  • Staff who telework full-time.
The CMS guidance also recommends that hospitals and PRTFs refer to the following CDC informational document when assessing requests for medical exemptions: Summary Document for Interim Clinical Considerations for Use of Covid-19 Vaccines Currently Authorized in the United States. Regarding religious exemptions, the CMS guidance directs hospitals and PRTFs to the Equal Employment Opportunity Commission Compliance Manual on Religious Discrimination for information on evaluating and responding to such requests. The guidance also discusses contingency plans that hospitals and PRTFs must have in place for staff who do not comply with these vaccination requirements, including those who qualify for an exemption. These plans can include actively seeking replacement staff or temporary vaccinated staff until permanent vaccinated replacements can be hired. Surveyors will begin evaluating for compliance 30 days after this guidance was issued during full surveys for recertification or reaccreditation, federal initial surveys, or complaint surveys. This guidance includes detailed instructions for surveyors, including levels of deficiency that may be assigned based on levels of staff vaccination and other factors including whether policies and procedures regarding staff Covid-19 vaccination have been developed and implemented by a facility.  In addition, the guidance specifies that surveyors may lower a citation level and/or enforcement action if they identify that prior to the survey that:
  • A hospital or PRTF “has no or has limited access to vaccine, and the hospital [or PRTF] has documented attempts to obtain vaccine access (e.g., contact with health departments and pharmacies)”; or
  • A hospital or PRTF “provides evidence that they have taken aggressive steps to have all staff vaccinated, such as advertising for new staff, hosting vaccine clinics, etc.”
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SAMHSA Extends Take-Home Methadone Flexibilities to OTPS for One Year

[vc_row][vc_column][vc_column_text]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.[/vc_column_text][/vc_column][/vc_row]

CMS to Require COVID-19 Vaccinations for Medicare and Medicaid Providers

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  • CMS is requiring that all staff of certain providers and suppliers participating in the Medicare or Medicaid programs receive the COVID-19 vaccine.
  • The IFR does not allow for weekly testing in lieu of vaccination.
  • The agency expressly preserves an employer’s right to require its employees to be fully vaccinated, regardless of the exemptions provided by the IFC.
Today, the Centers for Medicare and Medicaid Services (CMS) issued an interim final rule with comment (IFC), establishing COVID-19 vaccination requirements for staff at specified Medicare- and Medicaid-certified providers and suppliers. The IFC, entitled, “Medicare and Medicaid Programs: Omnibus COVID-19 Health Care Staff Vaccination” (rule; press release; FAQ) stipulates that all staff members, including those who perform their duties outside of a formal clinical setting, of certain providers and suppliers participating in the Medicare and Medicaid programs must be fully vaccinated against COVID-19 unless exempt. The IFC provides that individuals who provide services 100 percent remotely are not subject to the vaccination requirements; however, staff that primarily provide services remotely via telework who occasionally encounter fellow staff are still bound by the IFC’s provisions.
  • Background: On September 9, 2021 President Biden issued an executive order  (EO) entitled “Path out of the Pandemic,” a multifaceted COVID-19 response plan  that seeks to boost vaccinations and testing amid the surge in the delta variant. The President’s new plan focuses on six core components, including: (1) “Vaccinating the Unvaccinated;” (2) “Further Protection for the Vaccinated;” (3) “Keeping Schools Safely Open;” (4) “Increased Testing and Requiring Masking;” (5)  “Protecting Our Economic Recovery”; and (6) “Improving Care for Those with COVID-19.” To further the mission of this EO, CMS and the Occupational Health Services Administration (OSHA) issued regulations requiring certain individuals in the workforce to be vaccinated against COVID-19. In today’s IFC, CMS indicates that providers and suppliers may be covered by both the OSHA rules and the CMS IFC.
CMS is providing two implementation phases for the IFC in order to ensure efficiency in carrying out these requirements — effective 30 and 60 days after publication of this IFC in the Federal Register for Phases 1 and 2, respectively. The IFC notes that non-compliant facilities may be subject to civil money penalties, denial of payment for new admissions, or termination of their Medicare and Medicaid provider agreement. The agency also stated that it intends to retain these provisions beyond the conclusion of the public health emergency (PHE) as relevant, adding that it may deem these provisions permanent for facilities. To this end, CMS highlighted that this rulemaking is not associated with or tied to the PHE declarations, nor is there a sunset clause.
  • What’s Next? The final rule is expected to be published in the Federal Register on November 5, 2021, with an expected effective date of January 4, 2022. Comments to the IFC must be received no later than 60 days after the publication of the IFC in the Federal Register. While legal challenges to these guidelines are expected, CMS has already notably indicated in today’s IFC that, to the extent a court may enjoin any part of the rule, it intends that all other provisions or parts of provisions are to remain in effect.
Key policy items outlined in the IFC include:
  • Applicable Entities — The IFC provides that Medicare- and Medicaid-certified providers and suppliers must require that all applicable staff are fully vaccinated for COVID-19. Specifically, the entities subject to these requirements include:
    1. ambulatory surgical centers (ASCs);
    2. hospices;
    3. psychiatric residential treatment facilities (PRTFs);
    4. programs of all-inclusive care for the elderly (PACE);
    5. hospitals, including acute care hospitals, psychiatric hospitals, long term care hospitals, children’s hospitals, hospital swing beds, transplant centers, cancer hospitals, and rehabilitation hospitals;
    6. long term care (LTC) facilities, including skilled nursing facilities (SNFs) and nursing facilities (NFs);
    7. intermediate care facilities for individuals with intellectual disabilities (ICFs-IID);
    8. home health agencies (HHAs);
    9. comprehensive outpatient rehabilitation facilities (CORFs);
    10. critical access hospitals (CAHs);
    11. clinics, rehabilitation agencies, and public health agencies as providers of outpatient physical therapy and speech-language pathology services;
    12. community mental health centers (CMHCs);
    13. home infusion therapy (HIT) suppliers;
    14. rural health clinics (RHCs)/federally qualified health centers (FQHCs); and
    15. end-stage renal disease (ESRD) facilities.
  • In the IFC, CMS refers to the above facilities as residential congregate-care facilities, acute care settings, outpatient clinical care and services, and home-based care, generally. Notably, the requirements outlined in the IFC do not apply to assisted living facilities, group homes, or physician’s offices because they are not regulated by CMS health and safety standards.
  • Applicable Staff — CMS is requiring that all staff, regardless of patient contact or clinical responsibility, be fully vaccinated against COVID-19. The IFC stipulates that facility employees; licensed practitioners; students, trainees, and volunteers; and individuals who provide care, treatment, or other services for the facility and/or its patients, under contract or other arrangement, are subject to this requirement. The agency notes that staff who perform their duties outside of a formal clinical setting — such as home health, home infusion therapy, hospice, PACE programs, and therapy staff — are not precluded from the rule. Further, CMS asserts that individuals who provide services 100 percent remotely — including fully remote telehealth or payroll services — are not subject to the vaccination requirements. However, staff that primarily provide services remotely via telework who occasionally encounter fellow staff are still bound by the rulemaking.
  • Definition of “Fully Vaccinated” — Under the IFC, an individual is considered to be “fully vaccinated” if it has been two weeks or more since such individual completed a primary vaccination series defined as a single-dose or all doses of a multi-dose vaccine approved by the Food and Drug Administration (FDA). Importantly, individuals who receive vaccines listed by the World Health Organization (WHO) for emergency use but have not been approved or authorized by the FDA will also be counted as fully vaccinated for the purposes of the rulemaking. Additionally, individuals are not required to receive a booster or third dose of a vaccine in order to be considered fully vaccinated. However, providers and suppliers covered by the IFC must have a process for tracking and securely documenting the vaccination status of individuals who have obtained any booster.
  • Exceptions — CMS is requiring that applicable providers and suppliers establish and implement a process to allow staff to request an exemption from COVID-19 vaccination requirements based on applicable Federal law. The agency cites certain allergies; recognized medical conditions; or religious beliefs, observances, or practices as possible grounds for exemption. Providers and suppliers covered by the IFC are also required to document exemption requests from the vaccine requirements as well as the outcomes of those requests. Further, the agency is requiring that all applicable providers and suppliers establish a process to ensure the implementation of additional precautions to mitigate the transmission of COVID-19 for all staff who are not fully vaccinated. Notably, CMS expressly preserves an employer’s right to require that employees be fully vaccinated, regardless of the exemptions provided by the IFC.
  • Implementation — CMS is providing two implementation phases for the IFC in order to ensure efficiency in carrying out these requirements.
    • Phase 1. This phase includes a large majority of provisions in the IFC, including requirements that: (1) all staff have received at least the first dose of the COVID-19 vaccine, or a single dose COVID-19 vaccine, or have requested and/or been granted a lawful exemption to the requirement and (2) facilities have developed and implemented the aforementioned policies and procedures. Phase 1 is effective 30 days after the publication of this IFC in the Federal Register.
    • Phase 2. This phase requires that all applicable staff are fully vaccinated for COVID-19, unless granted an exception, which must be fully approved at this phase. Staff who have completed a primary vaccination series by this date are considered to have met these requirements, even if they have yet to complete the 14-day waiting period required for full vaccination. Phase 2 is effective 60 days after the publication of this IFC in the Federal Register.
  • Enforcement — CMS plans to issue interpretive guidelines, which include state survey procedures, to aid in assessing compliance with the new requirements among providers and suppliers following the publication of this IFC. The agency provides that non-compliant facilities may be subject to civil money penalties, denial of payment for new admissions, or termination of their Medicare and Medicaid provider agreement.
  • Other Provisions — This rule does not provide any prevention and control requirements for PRTFs, RHCs/FQHCs, and HIT suppliers. However, it does require that these entities create procedures in accordance with nationally recognized guidelines to limit the spread of COVID-19. Further, this IFC requires that providers and suppliers retain proper documentation of the vaccination status of each staff member, such as: (1) CDC COVID-19 vaccination card or legible photo of the card; (2) documentation of vaccination from a health care provider or electronic health record; or (3) a state immunization information system record.
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NABH and Other Organizations Applaud CDC for Adding Mental Illnesses to List of Underlying Conditions Associated with Higher Risk for Severe Covid-19.

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

[vc_row][vc_column][vc_column_text]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.[/vc_column_text][/vc_column][/vc_row]

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

[vc_row][vc_column][vc_column_text]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.[/vc_column_text][/vc_column][/vc_row]

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

[vc_row][vc_column][vc_column_text]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![/vc_column_text][/vc_column][/vc_row]