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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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HHS Provides Exemptions for Buprenorphine Prescribers for Fewer Than 30 Patients

The U.S. Department of Health and Human Services (HHS) announced Tuesday that practitioners prescribing buprenorphine, a controlled substance, for opioid use disorder to fewer than 30 patients are exempt from certain regulatory requirements codified under 21 U.S.C. 823(g)(2)(B)(i)-(ii).

Under the new guidance, physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives are exempt from having to make certain training related certifications and certifying their capacity to provide counseling and other ancillary services. The guideline does not remove the DATA 200 Waiver, otherwise known as the ‘X-Waiver.’

Providers are still required to file a Notice of Intent with the Substance Abuse and Mental Health Services Administration. The exemption applies to practitioners who are state-licensed and DEA-registered. It also generally limits prescribing to patients who are located in states where the practitioner is licensed.

Practicing under this exemption does not count toward the time requirements for prescribing to a higher patient limit under 21 U.S.C. 823(g)(2)(B)(iii). This exemption also applies to other Schedule III, IV, and V drugs.

Tuesday’s guidance encourages practitioners to provide access to psychosocial services to improve treatment retention and outcomes. In addition, medical education institutions are strongly encouraged to implement comprehensive training in substance use disorder diagnosis and management.

In late January, the Biden administration placed a freeze on Trump administration guidelines that intended to exempt physicians from the X-Waiver. That notice cited clinical concerns and stated the Executive Branch did not have the legal authority to make the change.

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NABH Highlights Residential Treatment as Critical Service for Youth in New White Paper

NABH is pleased to share with you Residential Treatment: A Vital Component of the Behavioral Healthcare Continuum, a white paper that emphasizes the importance and effectiveness of psychiatric residential treatment services for children and adolescents.

Together the NABH team and Youth Services Committee developed the paper as a resource for policymakers, regulators, the media, and other stakeholders to help explain how and why residential treatment is a vital component in the behavioral healthcare continuum—and how children and adolescents benefit from services in this setting.

NABH has posted the paper on the association’s new Youth Services page, which also includes shareable social media messages about the paper’s content for members to post on Twitter and LinkedIn. We urge you to share the link to the new page and the messages with your teams.

If you have questions about the paper or a comment to share with the Youth Services Committee, please contact John Snook, NABH’s director of government relations and strategic initiatives, who serves as the association’s staff liaison to the committee.

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

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CMS Proposes 2.1% Payment Increase to Per-Diem Base Rate for IPFs in FY 2022 

The Centers for Medicare & Medicaid Services (CMS) on April 7 proposed a 2.1-percent, Medicare payment increase to the per-diem base rate for inpatient psychiatric facilities (IPF) for fiscal year (FY) 2022.

This adjustment would increase the per-diem base rate to $833.50 from $815.22 and the electroconvulsive therapy (ECT) rate to $358.84 from $350.97.

CMS proposed several changes for inpatient psychiatric care in 2022, such as aligning an IPF policy regarding displaced residents from IPF closures and closures of IPF teaching programs with the policy changes that the agency made final in its FY 2021 IPPS rule.

In its FY 2022 proposed rule, CMS recommended the following changes to the IPF Quality Reporting Program:

  • Starting in FY 2023, the agency would add a requirement to report Covid-19 Vaccination Coverage Among Healthcare Personnel in the Centers for Disease Control and Prevention’s (CDC) National Healthcare Safety Network web portal;
  • For FY 2024, CMS would substitute the Follow-up After Psychiatric Hospitalization (FAPH) measure for the Follow-up After Hospitalization for Mental Illness (FUH) measure. The FAPH includes patients with substance use disorders and also expands the provider types who can provide follow-up care to include primary care providers;
  • For FY 2024, the agency would remove the three following measures:
    • Alcohol Use Brief Intervention Provided or Offered and Alcohol Use Brief Intervention Provided (SUB-2/2a),
    • Tobacco Use Brief Intervention Provided or Offered and Tobacco Use Brief Intervention Provided (TOB-2/2a), and
    • Timely Transmission of Transition Record -Discharges from an Inpatient Facility to Home/Self Care or Any Other Site of Care.

CMS is requesting information about how to develop a patient experience-of-care measure, as well as comments on including a patient-reported outcomes measure that assesses functional outcomes. The agency also wants feedback on measures either included in the IPFQRP now or that could be added that would be appropriate for digital data collection.

The agency is also seeking comment about how to modify reporting in a way that would improve collecting information on health disparities. CMS asked specifically for feedback on stratification of quality measure results by dual eligibility, race and ethnicity, improving demographic data collection, and potential creation of a facility equity score synthesizing results across multiple social risk factors.

CMS will accept public comments on the rule until June 7.

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U.S. Labor Department Issues Guidance on Parity Compliance

The U.S. Labor Department (DOL) has issued guidance on new implementation requirements for the Mental Health Parity and Addiction Equity Act (MHPAEA) that the 2021 Consolidated Appropriations Act requires.

Enacted on Dec. 27, 2020, the 2021 Consolidated Appropriations Act requires group health plans and health insurance issuers offering group or individual health insurance to perform and document analyses of how they comply with MHPAEA in their application of non-quantitative treatment limits (NQTLs) to mental health/substance use disorder (MH/SUD) benefits, compared with their application of NQTLs to medical/surgical benefits.

As of Feb. 10, 2021, health plans and insurers must make these comparative analyses available upon request to three federal agencies that oversee MHPAEA implementation: DOL, the U.S. Department of Health and Human Services, and the U.S. Treasury Department.

The required NQTL analyses by health plans and insurance issuers must include the following information:

  1. A description of the NQTL, plan terms, and policies at issue;
  2. Identification of the MH/SUD and medical/surgical benefits to which the NQTL applies;
  3. The factors used in applying the NQTLs to MH/SUD benefits and medical or surgical benefits;
  4. The evidentiary standards used for these factors;
  5. The comparative analyses demonstrating that the processes, strategies, evidentiary standards, and other factors used to apply the NQTLs to MH/SUD benefits, as written and in operation, are comparable to, and are applied no more stringently than, the processes, strategies, evidentiary standards, and other factors used to apply the NQTLs to medical/surgical benefits in the benefits classification; and
  6. The specific findings and conclusions reached by the plan or issuer, including any results of the analyses that indicate that the plan or coverage is or is not in compliance with the MHPAEA requirements.

The new law also requires the federal agencies to share findings regarding these analyses of MHPAEA compliance with the state governments where the plans or issuers are located and submit an annual report to Congress on these findings.

The guidance provides additional detail regarding the following topics:

  1. What information plans and issuers must make available to support their their comparative analyses demonstrating compliance with MHPAEA in their use of NQTLs;
  2. Examples illustrating when the federal agencies might determine that a comparative analysis of NQTLs is insufficiently specific and detailed;
  3. The types of documents that plans and issuers should be prepared to make available to the federal agencies to support their analyses and conclusions regarding their NQTL comparative analyses;
  4. What actions the federal agencies will take if they determine that a plan or issuer has not submitted sufficient information or is not in compliance with MHPAEA;
  5. Whether state agencies and plan participants and beneficiaries may request to see a plan or issuer’s comparative analysis of its use of NQTLs;
  6. Which specific NQTLs the federal agencies plan to focus on in the near term when requesting comparative analyses from plans and issuers for review, namely:
    • Prior authorization requirements for in-network and out-of-network inpatient services,
    • Concurrent review for in-network and out-of-network inpatient and outpatient services,
    • Standards for provider admission to participate in a network, including reimbursement rates, and
    • Out-of-network reimbursement rates (plan methods for determining usual, customary, and reasonable charges).
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Biden Administration Releases Drug-Policy Priorities for Year One

The Biden administration on Thursday released a statement outlining its first-year, drug-policy priorities to address America’s overdose and addiction crises.

White House Office of National Drug Control Policy (ONDCP) Acting Director Regina LaBelle noted in an announcement that these priorities will complement President Biden’s American Rescue Plan, which includes an investment of nearly $4 billion in behavioral health services.

In the next year, the ONDCP will work across government to implement seven priorities:

  • Expanding access to evidence-based treatment
  • Advancing racial equity in our approach to drug policy
  • Enhancing evidence-based harm reduction efforts
  • Supporting evidence-based prevention efforts to reduce youth substance use
  • Reducing the supply of illicit substances
  • Advancing recovery-ready workplaces and expanding the addiction workforce
  • Expanding access to recovery support services

The strategy identified several issues that NABH has discussed with the ONDCP, including, but not limited to, enforcing parity, improving reimbursement for services, permitting medications through telehealth without an in-person evaluation, and removing policy barriers to using contingency management and motivational incentives.

In addition, harm reduction appears to have a more visible role in the Biden administration than with previous administrations, as do issues related to workforce, recovery-ready workplaces, and recovery-support services.

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HHS-OIG Requests Recommendations for New or Updated Safe Harbor Provisions

The U.S. Health and Human Services Department’s Office of Inspector General (OIG) on Wednesday requested proposals and recommendations to develop new, or to modify existing, safe harbor provisions under the Social Security Acts federal anti-kickback statute.

The statute applies criminal penalties for whoever knowingly—and willingly—offers, pays, solicits, or receives money to induce or reward the referral for, or purchase of, items and services that are reimbursed under any federal healthcare program. Because of the statute’s broad reach, there was concern that the statute included relatively harmless business arrangements.

This has had an especially negative effect on implementing “contingency management/motivational incentive treatment” practices in which individuals receive small rewards for improving treatment outcomes. Contingency management is an evidence-based practice that the National Institute on Drug Abuse and the Substance Abuse and Mental Health Services Administration developed as a joint initiative in 2001.

This treatment intervention is especially critical for individuals with stimulant use disorders, for which there are no effective treatment medications. According to the Centers for Disease Control and Prevention, drug overdoses involving psychostimulants increased 33.3% between April 2019 and April 2020, the highest percentage increase of all categories of drugs involved in overdoses for that time period.

Healthcare providers and others could comply with safe harbor conditions so that they are not subject to the federal anti-kickback statute.

The OIG will accept comments on the proposed rule until Tuesday, Feb. 16, 2021. Click here to learn how to submit recommendations.

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Biden Chooses California Attorney General Xavier Becerra to Lead HHS

President-elect Joseph Biden has selected Xavier Becerra, California’s attorney general, as his nominee to lead U.S. Health and Human Services Department (HHS).

Becerra, who represented California in the U.S. House of Representatives from 1993 to 2017, was chairman of the House Democratic Caucus from 2013 to 2017 and served on the powerful House Ways and Means Committee. He earned his bachelor and law degrees from Stanford. If confirmed, Becerra would be the first Latino to lead HHS.

A fierce champion of the Patient Protection and Affordable Care Act, Becerra is leading 20 states and Washington, D.C.  to protect the seminal 2010 healthcare law from being dismantled. He would also oversee the department at a critical time during the Covid-19 pandemic, as caseloads surge and a massive vaccination effort is set to launch soon.

Meanwhile, Biden chose Vivek Murthy, M.D. to reprise his role as U.S. Surgeon General. Murthy served as the nation’s 19th U.S. Surgeon General during the Obama administration from December 2014 until January 2017. Murthy completed his internal medicine residency at Brigham and Women’s Hospital and Harvard Medical School, and also led and managed medical teams as a faculty member.

Biden also named Rochelle Walensky, M.D., M.P.H., chief of infectious diseases at Massachusetts General Hospital, to lead the Centers for Disease Control and Prevention in Atlanta. Walensky also serves as professor of medicine at Harvard Medical School and is an expert on AIDS and HIV.

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