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.

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.

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.

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.   

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.

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.

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.

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.

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.

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!

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.

[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]

[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]

[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]

[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]

[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]

[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]

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

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!

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.

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).

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.

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 Act’s 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.

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.

The U.S. Health and Human Services Department (HHS) will host a webinar on Friday, Nov. 13 at 1 p.m. ET to review the updated guidance for hospital data reporting requirements during the Covid-19 pandemic. This webinar is the fourth webinar HHS has hosted to provide guidance to the nation’s healthcare providers on this topic and will include a question-and-answer period. Click here to register and here for the webinar slide deck.

The Centers for Medicare and Medicaid (CMS) has corrected a misstatement in its Oct. 8 news release to say the nation’s healthcare providers and suppliers cannot use Provider Relief Funds (PRF) to repay Medicare loans the agency has made during the Covid public health emergency. The correction first appeared in an FAQ on Oct. 9. CMS subsequently corrected its original news release

The Centers for Medicare & Medicaid Services (CMS) said Thursday it will give Medicare Part A and B providers and suppliers an additional year to repay loans the agency made to them during the Covid-19 public health emergency (PHE). CMS had advanced payments to Medicare Part A and B providers and suppliers through the Accelerated and Advance Payment (AAP) program to help cover costs as the PHE disrupted healthcare services this year. Initially CMS had required providers to start making repayments in August 2020. “CMS’ advanced payments were loans given to providers and suppliers to avoid having to close their doors and potentially causing a disruption in service for seniors,” CMS Administrator Seema Verma said in an announcement. “While we are seeing patients return to hospitals and doctors providing care we are not yet back to normal,” she added. According to the agency’s new terms, after that first year, CMS will automatically recoup 25% of Medicare payments otherwise owed to the provider or supplier for 11 months. After that period, CMS will increase the recoupment amount to 50% for another six months. CMS said it will send letters to providers who have any outstanding balances after the entire period—a total of 29 months— informing them that repayment will be subject to a 4% interest rate. Those letters will also include guidance on how to request an Extended Repayment Schedule (ERS) due to financial hardship. The agency’s announcement urged providers and suppliers to contact their Medicare Administrative Contractor for information about how to request an ERS. An ERS will allow a provider or supplier to repay these debts over the course of three to five years. CMS also said providers and suppliers may use Provider Relief Funds to repay these Medicare loans. CMS said it will communicate with each provider and supplier about the amount they owe and all applicable terms in the coming weeks.

The Centers for Medicare & Medicaid Services (CMS) has released guidance that requires Medicare- and Medicaid-participating psychiatric hospitals to report Covid-19 data to the agency on a weekly basis. CMS published an interim final rule in early September that said hospitals would be required to submit Covid-19 data during the public health emergency in a frequent, standardized way that the U.S. Health and Human Services Department (HHS) secretary specified. This week’s awaited guidance makes it clear that the nation’s psychiatric hospitals—along with rehabilitation hospitals—need to report their data weekly, and not on a daily basis as other hospital types are required to do. The agency listed the required data in new guidance and also developed an infographic that highlights when the agency plans to alert hospitals about gaps in reporting and compliance. Links to these new materials are also available our Covid-19 resources webpage.

The Department of Health and Human Services (HHS) on Thursday announced an additional $20 billion is available from the Provider Relief Fund (PRF) for healthcare providers to recover Covid-19-related financial losses and changes in operating expenses. HHS highlighted behavioral healthcare providers in its announcement and encouraged these providers to apply for this latest round of funding. HHS has developed a list of behavioral healthcare providers who are now eligible for funding, such as addiction counseling centers, mental health counselors, and psychiatrists. “Our behavioral health providers have shouldered the burden of responding and confronting this expanded challenge triggered by the pandemic,” HHS said in the announcement. “When traditional face-to-face counseling was restricted and new telehealth flexibilities were put in place in response to the pandemic, many behavioral health providers invested in and adopted telehealth technologies to continue providing patient care.” Providers are encouraged to apply early. Be sure to apply between Monday, Oct. 5 through Friday, Nov. 6, 2020. Eligible providers include behavioral healthcare providers who had previously not been eligible (presumably because they did not participate in Medicare or Medicaid); providers who had already received PRF payments; and providers who began practicing in 2020 and were therefore not eligible to apply previously. Providers who apply will be considered first for the 2% of patient care revenue that has already been made available. If they have not yet received payments from the PRF amounting to 2% of patient care revenue, they will receive funding to reach that amount. In addition, those who apply will receive an add-on payment above the 2% from the $20 billion allocation based on the following criteria:

• Change in operating revenues from patient care;
• Change in operating expenses from patient care, including expenses incurred related to the coronavirus; and
• Payments already received through the prior PRF distributions

All providers receiving PRF funding will be required to accept the associated terms and conditions including reporting requirements. HHS said it plans to hold webinars to assist with the application process.

The Department of Health and Human Services (HHS) has issued guidance that contradicts the department’s June FAQ about calculating lost revenue from Covid-19 that may be recovered through the Coronavirus Aid, Relief, and Economic Security Act’s (CARES) Provider Relief Fund (PRF). In the June FAQ, HHS said providers could “use any reasonable method of estimating the revenue during March and April 2020 compared to the same period had Covid-19 not appeared.” This latest guidance defines lost revenue that may be recovered as being limited to “a negative change in year-over-year net patient care operating income.” The guidance further specifies that providers generally will only be able to apply their PRF payments to lost revenue up to a facility’s net patient operating income for 2019. As HHS announced previously, providers who have received more than $10,000 from the PRF are required to submit a report by Feb.15, 2021, on the use of those funds through Dec. 31, 2020, and, if necessary, a second and final report by July 31, 2021. The PRF funding provided through the CARES Act and subsequent legislation was intended to reimburse eligible providers for healthcare-related expenses and lost revenues attributable to Covid-19. HHS had included a general commitment to reporting on the use of the PRF funds in the terms and conditions that PRF fund recipients agreed to for the funding. Previously HHS said it would issue detailed reporting instructions by Aug. 17, 2020 and the reporting system would be available Oct. 1. The reporting system is not yet available. Please contact your U.S. senators and representatives today and ask them to urge the White House and HHS to reinstate the Covid-19 PRF reporting requirements that HHS outlined in June. Providers must be able to use these funds to recover any revenue lost due to Covid-19, rather than struggling to once again change course to respond to shifting guidance from HHS.

The Centers for Medicare & Medicaid Services (CMS) is requiring Covid-19 data collection and reporting as a condition of participation (CoP) for hospitals participating in the Medicare and Medicaid programs, including psychiatric facilities. CMS added the requirement with other provisions in an interim final rule and said it will accept comments for 60 days. The rule noted the requirement will become effective when it is published in the Federal Register, although it did not list a specific date. Under the new requirement, hospitals will need to report daily data, including—but not limited to—the number of confirmed or suspected Covid-19 positive patients, intensive care unit beds occupied, and the availability of supplies and equipment, such as ventilators and personal protective equipment. CMS warned in the rule that if a hospital fails to comply with this new CoP, it could face possible termination from the federal healthcare programs.

The Department of Health and Human Services (HHS) has extended the deadline to apply for Phase 2 General Distribution Funding for Medicaid, Medicaid managed care, Children’s Health Insurance Program, dental providers, and certain Medicare providers until Sunday, Sept. 13. This funding is through the Provider Relief Fund, which the federal government established in this year’s Coronavirus Aid, Relief, and Economic Security Act (CARES) and Paycheck Protection Program and Health Care Enhancement Act. These payments do not need to be repaid to the government if providers comply with terms and conditions. HHS has extended this Phase 2 General Distribution Funding deadline before, with the latest deadline scheduled for this Friday, Aug. 28. Providers now have a few extra weeks to apply. Click here to read HHS’ six steps to applying for the Phase 2 General Distribution.

Data Collection for the 2020 NABH Annual Survey Starts this Week!   I am pleased to announce that data collection for the 2020 NABH Annual Survey will begin on Friday, Aug. 28. Your participation in this survey will help us continue to provide an accurate, up-to-the-minute picture of the U.S. behavioral healthcare industry. Please note that we have added a few new questions related to substance use. This will help us better measure our membership’s activities. Look for a Message from Consulting Firm Dobson DaVanzo & Associates, LLC Our contractor, Dobson DaVanzo & Associates, will conduct the NABH Annual Survey again this year. Dobson DaVanzo & Associates brings extensive data-analysis experience and data-security expertise to this project. The firm has analyzed data for the last several NABH Annual Surveys. Dobson DaVanzo will send personalized links to the survey instrument via e-mail directly to the CEOs of all NABH-member hospitals and residential treatment centers. If you receive a request to participate in the survey, please respond as soon as possible. Submit Your Data Online The 2020 online entry form will provide a personalized, secure e-mail link for each facility. You will be able to enter, save, and review data— and review that data internally with others in your organization who have completed the survey—until you click “Done” on the survey’s last page. You may not make changes after you have submitted your data. You will receive complete instructions with the survey instrument. Your Participation in Essential! The survey data are used in dozens of ways to help protect mental health and addiction treatment benefits; ensure fair and adequate payments; improve patient care; and communicate trends to the media, payers, benefit consultants, and the public. Within your organization, you can also use the NABH aggregate data you will receive to measure how your facility compares with national trends. Because the survey collects the most current information about the field, it can provide a valuable perspective for administrative and clinical operations. The NABH Annual Survey Report is an invaluable strategic planning tool as well as a reference document every behavioral healthcare organization should have. If you have any questions or suggestions about this survey, please feel free to contact me directly at Shawn@nabh.org or contact Kirsten Beronio at Kirsten@nabh.org. Thank you for your time. We appreciate your help!

The Health and Human Services Department (HHS) will host an informational webinar for healthcare providers about applying to the CARES Act Provider Relief Fund this Thursday, Aug. 13 at 3 p.m. ET. Please click here to register. HHS announced on July 31 that certain Medicare-participating providers would have another opportunity to receive additional Provider Relief Fund payments. These are the providers who missed an early June deadline to apply for additional funding equal to 2% of their total patient care revenue from the $20 billion portion of the $50 billion phase 1 General Distribution, including many Medicaid, Children’s Health Insurance Program (CHIP), and dental providers with low Medicare revenues. These eligible providers may now submit their application for possible funding by Friday, Aug. 28. HHS has also extended the deadline to Aug. 28 for providers who participate in Medicaid and CHIP to apply for up to 2% of their total patient care revenue from a separate funding distribution for Medicaid providers.  To be eligible for this funding, providers must not have received any funding from the Medicare focused distribution of funding from the Provider Relief Fund. Providers can access the same portal to apply for both Medicare-based and Medicaid-based funding. HHS has hosted a series of webinars to address questions from providers throughout the application process, and Thursday’s webinar is the next provider and provider organization webinar in this series.

The Department of Health and Human Services (HHS) extended the deadline to Friday, Aug. 28 from Monday, Aug. 3 for healthcare providers who participate in Medicaid and CHIP to apply to the Provider Relief Fund established in the Coronavirus Aid, Relief, and Economic Security (CARES) Act. HHS had previously extended this deadline to Aug. 3 from July 20. HHS said that it plans to issue a simplified application form soon. In addition, HHS is re-opening the portal for Medicare-participating providers to apply for funding set aside from the Provider Relief Fund for Medicare providers. The previous deadline to apply for this distribution was June 3. Providers will now have until Aug. 28 to apply for the balance of funding up to 2% of their annual patient revenue. HHS is re-opening this application process after learning that many providers, including many Medicaid and CHIP providers, did not apply to the prior Medicare-based distribution because they had relatively low Medicare revenues.  HHS also announced it is working on another distribution of funding from the Provider Relief Fund focused on providers who have not received any of this funding, including those who only bill commercially or do not directly bill for the services they provide to Medicare and Medicaid beneficiaries. Information on how to apply for the various Provider Relief Fund distributions is on HHS’ website.

The remedies hearing in the Wit v. UnitedHealthcare case scheduled for this week has been delayed to Wednesday, Sept. 2. NABH has learned that U.S. Chief Magistrate Judge Joseph Spero has re-scheduled the hearing due to meetings related to Covid-19. Members of the public and press are welcome to join the webinar, and NABH will send an updated Zoom link when it becomes available.

The Centers for Medicare & Medicaid Services (CMS) will update the Medicare payment rate for the Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS) by 2.2% in Fiscal Year (FY) 2021, the agency announced in a final rule late Friday. In its April proposed rule, CMS had estimated a 2.4% payment rate update for IPFs next year. The agency included its updated estimates and calculations in a fact sheet accompanying Friday’s final rule. According to the rule, CMS will allow advanced practice providers, including physician assistants, nurse practitioners, psychologists, and clinical nurse specialists, to operate within the scope of practice allowed by state law by documenting progress notes in the medical record of patients for whom they are responsible, receiving services in psychiatric hospitals. NABH has advocated for this policy change and is pleased the agency made this update. CMS also finalized its proposal to adopt revised Office of Management and Budget (OMB) statistical area delineations resulting in wage index values that the agency said are “more representative of the actual costs of labor in a given area.”

NABH is requesting information from our members to show how expanded coverage of telehealth during the Covid-19 pandemic has helped maintain and even improve access to behavioral healthcare. This information will help us advocate for continuation of this expanded coverage of telehealth after the public health emergency ends. Here is a quick survey to share the requested data on the impact of the telehealth expansion. Please submit the survey and any additional information as soon as possible, but no later than Friday, July 31. Please email Kirsten Beronio, Director of Policy and Regulatory Affairs (kirsten@nabh.org) with any questions.

Friday, the U.S. Department of Health and Human Services (HHS), announced that it is extending the application deadline for Medicaid and CHIP Provider Relief Fund distribution from today July 20, 2020 to August 3, 2020. In June, HHS announced plans to distribute approximately $15 billion to eligible providers that participate in state Medicaid and CHIP programs who had not yet received a payment from earlier distributions from the Provider Relief Fund. This HHS fact sheet explains the application process. In addition, HHS is holding focus groups tomorrow and Wednesday to identify opportunities to increase application volumes in the current Medicaid/CHIP distribution. The focus group discussion will center on three topics-

1. Awareness of the PRF program and Medicaid/CHIP distribution
2. Understanding of program components, such as eligibility
3. Technical challenges faced during the application process

These sessions will be held on Tuesday, July 21^st from 6:30 – 7:30 pm ET and Wednesday, July 22^nd from 3:00 – 4:00 pm ET. To confirm your participation, please send an email to preston.white@mckinsey.com with your name, email, title, organization and state, and note which session you would like to attend. If you have any questions, please reach out to our Director of Policy and Regulatory Affairs, Kirsten Beronio.

HHS announced that as of Wednesday, July 15, the Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN) Covid-19 module will no longer be an option for hospitals to fulfill the agency’s request for daily data reporting on bed capacity, utilization, personal protective equipment (PPE), and in-house laboratory testing data. Instead, HHS is asking hospitals to use one of these four options to report that information:

• If your state has assumed reporting responsibility, submit all data to your state each day and your state will submit on your behalf. Your state can provide you with a certification if they are authorized to submit on your behalf.
• Submit data to TeleTracking™. All instructions about the data submission are on that site and the new and updated fields will be ready as of July 15.
• Authorize your health information technology (IT) vendor or other third party to share information directly with HHS.
• Publish to the hospital or facility’s website in a standardized format, such as schema.org.

For additional details about these options, please see page 9 in HHS’s updated guidance. This information is also posted to NABH’s Covid-19 resources page.

The Substance Abuse and Mental Health Services Administration (SAMHSA) on Monday issued a final rule to update the Confidentiality of Substance Use Disorder Patient Records known as 42 CFR part 2 (or “part 2”) regulations, further aligning the regulations with other healthcare delivery rules. Key changes include:

• Part 2 programs may share information verbally with a non-part 2 provider without subjecting the non-part 2 record to the requirements of part 2, as long as the non-part 2 provider segregates specific substance use disorder (SUD) records.
• Patients may consent to disclosures without naming a specific individual to receive this information; the update provides instructions for disclosures to exchanges and research institutions and provides guidance on disclosures related to care coordination and case management.
• Non-part 2 providers are not required to redact information in their medical records and may redisclose information if the patient has signed a written consent, or if the disclosure is otherwise permitted under the regulations.
• Written consents expressly allow sharing information with 18 types of payment and healthcare operations, including for care coordination and case management.
• Non-opioid treatment providers have access to central registries if they have a treatment relationship to the patient.
• Opioid treatment programs have new permissions to disclose information to prescription drug monitoring programs.
• During medical emergencies, information may be shared among part 2 programs or other SUD treatment providers during state or federally declared natural and major disasters.
• Disclosures for conducting scientific research may be made to non-Health Insurance Portability and Accountability Act (HIPAA) covered entities and those who are not subject to the Common Rule.
• Permits federal, state, and local agencies to conduct audits and evaluations.
• Extends to 12 months the period of placement of undercover agents or informants, which may be further authorized by a new court order.

These changes do not include provisions that recently became law in the Coronavirus Aid, Relief and Economic Security Act (CARES Act). CARES Act provisions are effective March 27, 2021. This rule is expected to be published in the Federal Register this Wednesday, July 15, and will become effective within 30 days of its publication. For questions about this rule, please contact Sarah Wattenberg, NABH’s director of quality and addiction services, at sarah@nabh.org.

HHS said Tuesday it expects to distribute about $15 billion through the department’s Health Resources and Services Administration (HRSA) to eligible providers who participate in state Medicaid and CHIP programs and have not received a payment from the Provider Relief Fund General Distribution. HRSA will also distribute about $10 billion from the Provider Relief Fund to the nation’s safety-net hospitals, which is expected to happen this week. HHS said it will launch an enhanced Provider Relief Fund Payment Portal on Wednesday that is intended to allow eligible Medicaid and CHIP providers to report their annual patient revenue, which will be used as a factor for HHS to determine their Provider Relief Fund payment. According to an announcement, the payment to each provider will be at least 2% of reported gross revenue from patient care. HHS said it will determine the final amount that each provider receives after data is submitted, including information about the number of Medicaid patients providers serve. To be eligible for this funding, healthcare providers must not have received payments from the $50 billion Provider Relief Fund General Distribution and either have directly billed their state Medicaid/CHIP programs or Medicaid managed care plans for healthcare-related services between January 1, 2018, to May 31, 2020. On Monday, HHS contacted all hospitals, asking them to update information on their COVID-19 positive-inpatient admissions for the period January 1, 2020, through June 10, 2020. This information will be used to determine a second round of funding to hospitals in COVID-19 hotspots to ensure they are equitably supported in the battle against this pandemic. To determine their eligibility for funding under this $10 billion distribution, hospitals must submit their information by June 15, 2020 at 9:00 PM ET. HHS said close to 1 million healthcare providers may be eligible for these patients. Click here for more information about eligibility and the application process.

The Centers for Medicare & Medicaid Services (CMS) on April 10 said it expects payments to inpatient psychiatric facilities to increase by 2.4% in fiscal year 2021, boosting the federal per diem base rate to $817.59 from $798.55. An announcement about CMS’ proposed inpatient psychiatric facility prospective payment system (IPF-PPS) rule said the agency estimates total IPF payments to increase by $100 million next year. The rule will be published in the Federal Register on Tuesday, April 14. According to the proposed rule, CMS will adopt the Office of Management and Budget (OMB) guidelines regarding geographic delineation of statistical areas, which CMS said should result in wage index values better representing the actual labor costs in a given area. “CMS is proposing that all IPF providers negatively impacted in their wage index, regardless of the circumstance causing the decline, be capped at a 5-percent decrease for FY 2021,” the announcement said. Table 6 at the start of page 57 in the proposed rule shows changes in 2021 from 2020 for different facility types. The agency said it is not making changes to the IPF Quality Reporting Program. NABH is analyzing the proposed rule and will submit comments by the June 9 deadline.

HHS announced on Friday it is distributing $30 billion immediately to healthcare providers fighting the deadly Covid-19 pandemic. The funding is the first portion of the $100 billion allotted to hospitals and other providers as part of the Coronavirus Preparedness and Response Supplemental Appropriations (CARES) Act that President Trump signed on March 27. The funding will arrive via direct deposit to eligible providers starting on Friday, April 10. HHS’ announcement said the money is in the form of payments, not loans, so the money will not need to be repaid. Eligible healthcare providers include all facilities and providers that received Medicare fee-for-service reimbursements in 2019. According to HHS, payments to practices that are part of larger medical groups will be sent to the group’s central billing office. Click here to learn how HHS will determine the payments and what eligible providers need to do. To receive funding, providers must agree not to seek to collect out-of-pocket payments from a Covid-19 patient that are greater than what the patient would have otherwise been required to pay if an in-network provider had provided care, HHS said. HHS has created a public website that shows all Covid-19 grant and cooperative agreement awards, which features a U.S. map detailing the amounts awarded by states, graphics highlighting the numbers of awards, amounts awarded by agency, and more.

The White House on Monday released a $4.8 trillion budget for 2021 that would modify Medicaid’s Institutions for Mental Diseases (IMD) exclusion to provide states with flexibility to provide inpatient mental health services to beneficiaries with serious mental illness (SMI). The budget requests $94.5 billion for HHS, a 10-percent decrease from the 2020 enacted level. Although Congress is likely to reject President Trump’s proposal, the budget is significant for outlining the president’s top policy priorities as he seeks re-election in November. Notably for NABH, those priorities address mental health and addiction treatment services. These provisions include changes to the IMD exclusion, which under current law states Medicaid cannot pay for certain inpatient stays at IMDs. The president’s budget would provide more than $5 billion in new federal funding to states to ensure the full continuum of care exists to provide help to people with SMI. These changes—which appear in summary tables at the end of the budget proposal—would exempt Qualified Residential Treatment Programs (QRTPs) from the IMD exclusion. The budget also includes $225 million for Certified Community Behavioral Health Clinics (CCBHC) expansion grants, and would extend, through 2021, the CCBHC Medicaid demonstration programs to improve community mental health services for the eight states participating currently in the demonstration. In addition, the White House has proposed $25 million to expand primary healthcare services to address homelessness. These provisions, together with the changes to the IMD exclusion, are “part of a comprehensive strategy that includes improvements to community-based treatment,” the budget proposal noted. Meanwhile, the president’s 2021 budget would continue 2020 funding to expand medication assisted treatment (MAT) from a small pilot program to half of all eligible Bureau of Prisons (BOP) facilities and provide an additional $37 million to complete MAT expansion to all eligible BOP facilities. NABH will continue to analyze the Trump administration’s budget proposal and keep NABH apprised of any additional details regarding the IMD exclusion, MAT funding, and other topics related to the association’s policy priorities.

The Office of National Drug Control Policy (ONDCP) has issued its 2020 National Drug Control Strategy (Strategy) and accompanying National Treatment Plan (NTP) that includes action items for federal agencies and external stakeholders to increase access to care and close the addiction treatment gap. The Strategy is presented using the domains of prevention, treatment and recovery, and supply-side strategies for reducing the availability and consumption of illicit drugs. These domains are established as ‘pillars’ that undergird the federal initiatives of expanding the early intervention, treatment and recovery infrastructure; improving the delivery system; and improving quality. Specifically, the NTP calls for treatment expansion and improved quality by:

• Developing protocols for medically managed withdrawal including MAT to prevent relapse and promote stabilization;
• Increasing emergency department use of addiction medicine specialty services;
• Exploring the inclusion of stimulant disorder treatment in opioid treatment programs;
• Increasing access to all medication and psychosocial services, promoting syringe exchange, interim methadone, mobile methadone vans, and peer outreach. One objective of the federal Performance and Reporting System is to make sure 100% of all specialty providers offer MAT by 2020;
• Adopting model state specialty SUD treatment licensing laws;
• Developing mobile and online platforms with updated information on treatment slot availability with online appointment capacity;
• Encouraging public and private payers to cover comprehensive services and improve reimbursement rates where out-of-network rates are higher;
• Urging providers to subsidize and provide treatment scholarships; and
• Exploring the idea of developing national consensus standards for addiction treatment to consolidate treatment quality standards.

If you have questions about the Strategy or NTP, please contact Sarah Wattenberg, NABH’s director of quality and addiction services.

The age-adjusted rate of U.S. drug overdose deaths in 2018 was 4.6% lower than the rate in 2017, the Centers for Disease Control and Prevention reported Thursday. New data from the National Vital Statistics System also show there were 67,367 drug overdose deaths in the United States in 2018, 4.1% fewer than the 70,237 deaths reported in 2017. Despite the decline in overall drug overdose deaths, there was a 10% increase in the rate of drug overdose deaths involving synthetic opioids other than methadone, such as fentanyl, in 2018 compared with 2017. Furthermore, the age-adjusted rate of overdose deaths involving cocaine more than tripled from 2012 through 2018, while the rate of deaths involving certain psychostimulants, such as methamphetamine, increased nearly five-fold. The CDC also reported that decreases in life expectancy between 2014 and 2017 were driven mostly by deaths due to unintentional injuries, suicide, and Alzheimer’s disease. Improvements in life expectancy between 2017 and 2018, meanwhile, were driven by decreases in  mortality from cancer, unintentional injuries, and chronic lower respiratory diseases. The positive contributions to the change in life expectancy were offset, in part, by the rising number of deaths by suicide, chronic liver disease, and cirrhosis. Unintentional injuries and suicide remain in the top ten leading cause of death in the United States.

The Centers for Medicare and Medicaid Services (CMS) announced a Medicare payment increase of 1.5 percent next year for inpatient psychiatric facilities in the final Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS) rule the agency released today. Compared with the 2019 payment rate, the increase reflects a total increase of $65 million for Medicare-participating inpatient psychiatric facilities in fiscal year 2020. The payment update aligns with the agency’s proposed rule earlier this year. The rule also adds one new claims-based measured starting in fiscal year 2021 payment determination and continuing in subsequent years. The measure—Medication Continuing Following Inpatient Psychiatric Discharge (National Quality Forum #3205)—assesses whether patients admitted to IPFs with diagnoses of Major Depressive Disorder, schizophrenia, or bipolar disorder filled at least one evidence-based medication within two days before discharge or during the 30-day, post-discharge period.

The Centers for Medicare & Medicaid Services (CMS) on July 2 released Frequently Asked Questions on the Emergency Medical Treatment and Labor Act (EMTALA) and Psychiatric Hospitals, a six-page memo addressing common concerns psychiatric hospitals and hospital emergency departments have regarding compliance with EMTALA. EMTALA has been a top regulatory priority for NABH and our team has worked closely with CMS on this issue. In March, NABH released The High Cost of Compliance: Assessing the Regulatory Burden in Inpatient Psychiatric Facilities, a detailed report that quantifies the compliance costs related to EMTALA for inpatient psychiatric care providers. The analysis—which NABH commissioned Manatt Health to produce—also addresses ligature risk, a topic CMS addressed this past April in draft guidance. Here are key excerpts from CMS’ July 2 FAQ Memo:

• How do surveyors evaluate whether a staff person is qualified to perform a Medical Screening Exam?
  • The surveyor can review state scope of practice as well as hospital bylaws or rules and regulations to determine if the medical screening exams being performed are within a professional’s scope of practice.

• What is the expectation of a psychiatric hospital when a medical emergency presents in terms of who can conduct a medical screening exam?
  • EMTALA requires hospitals to perform medical screening examinations within their capabilities. If the psych hospital doesn’t have the ability to perform a comprehensive medical screening exam (or provide stabilizing treatment), but the screening exam it performs indicates that the patient may have an emergency medical condition, the hospital is required to arrange an appropriate transfer to a facility for further evaluation and treatment. The hospital is expected to use its resources to perform the exam and provide care within its capabilities prior to transfer. This might be as simple as performing ongoing assessments with repeat vital signs and ensuring the patient is in a safe environment.

• What is required in terms of stabilization and transfer for non-psychiatric emergencies?
  • There is no expectation that a psych hospital with basic clinical services would be expected to provide the same level of comprehensive medical assessments or treatment as an acute care hospital.

• How does EMTALA intersect with admission?
  • If the hospital has the staff and facilities to stabilize the emergency medical condition, it is expected to do so. This includes inpatient admission, as appropriate. Having an empty inpatient bed does not always translate to having the capability or capacity to stabilize the emergency medical condition.

• Can an ER physician in a facility that does not provide psychiatric care conduct the mental health screening?
  • It is within the scope of practice for ED physicians and practitioners to evaluate patients presenting with mental health conditions, same with any other medical, surgical, or psychiatric presentation. The ED practitioner may utilize hospital resources to assist with the examination and treatment or arrange appropriate transfers if additional resources are needed.

Read the full memo here.