FDA Releases Guidance on Constructing Effective Clinical Trials for Devices
The FDA on Thursday issued guidance about constructing effective clinical trials to develop medical devices that treat patients who misuse opioids.
The new guidance is intended to improve both the design and development of clinical studies to provide a reasonable assurance of safety and effectiveness for a device intended to treat OUD. Challenges in developing OUD device studies include inaccurate patients report of drug use, high rates of missing data, and confounding effects of concomitant drug treatments.
The guidance is not legally enforceable.
CMS Updates IOP and PHP Payment Rates for 2025
The Centers for Medicare & Medicaid Services (CMS) this week issued its calendar year (CY) 2025 Medicare hospital outpatient prospective payment system (OPPS) proposed rule, which proposes a net increase of 2.3 percentage points, relative to current year rates. The net update reflects a market basket increase of 3.0 percentage points and the statutorily required 0.4 percentage point cut, along with several budget neutrality adjustments and a minor increase in outlier payments.
The proposed update would apply to services paid under the OPPS, intensive outpatient programs (IOP), partial hospitalization programs (PHP), community mental health centers (CMHCs), opioid use disorder (OUD) treatments in an IOP, and other settings.
In addition to other items, the proposed rule addresses the behavioral healthcare provisions summarized below and lists in Table 68 the eight proposed ambulatory payment classification (APC) per diems for IOPs and PHPs that are set according to the number of services provided per day.
IOPs
For the IOP benefit established last year, the current dual-rate, per-diem structure would be maintained: one rate for days with three services and another rate for days with four or more services. In general, the structure of the IOP mirrors the design of the PHP, including provisions on coding, billing, and payment policies.
The rule defines IOPs as distinct and organized outpatient programs of psychiatric services provided for individuals who have an acute mental illness or substance use disorder, consisting of a specified group of behavioral health services paid on a per-diem basis for a minimum of nine hours of IOP services per week, or other payment system.
Opioid Treatment Program (OTP) Payment Add-On
For the new OPPS coverage of OUD treatments that OTPs provide, CMS would maintain the payment add-on of three times the payment rate for APC 5861 (intensive outpatient of three services per day) for hospital-based IOPs.
FQHCs and RHCs
The annual payment update for IOP services provided by federally qualified health centers and rural health clinics will be addressed in the pending physician fee schedule proposed rule for CY 2025.
PHPs
For PHPs, services provided in hospital outpatient departments and CMHCs, CMS proposes to maintain the current payment structure, which sets reimbursements based on whether a patient receives three services versus four or more services per day. PHPs are intensive, structured outpatient programs that are alternatives to psychiatric hospitalization, consisting of a specified group of mental health services paid on a per-diem basis for a minimum of 20 hours of PHP services per week, based on per diem costs.
Access to Non-Opioid Treatments for Pain Relief
As mandated by Congress, CMS is proposing temporary add-on payments for certain non-opioid treatments for pain relief. This complex provision would take effect from Jan. 1, 2025 through Dec. 31, 2027, and would require certain clinical evidence for medical devices and FDA-approved indications for pain management. The payment add-on would be capped at the estimated average of 18% of the full OPPS payment, calculated using the top five procedures by volume for each drug or device. Table 84 in the rule lists the proposed seven injections and other items that would qualify for a payment add-on under this provision.
CMS will accept comments on this rule through Sept 9. See the agency’s related fact sheet for more information.
CMS’ Proposed 2025 PFS Rule Would Cut Overall Payments by 2.8%
In its proposed rule for the calendar year (CY) 2025 physician fee schedule, the Centers for Medicare & Medicaid Services on Wednesday recommended reducing the conversion factor by 2.8% to $32.36 in CY 2025, compared with $33.29 in CY 2024. This change reflects the expired 2.93% statutory payment increase for CY 2024; a 0.00% conversion factor update under the Medicare Access and Children’s Health Insurance Program Reauthorization Act; and a .05% budget-neutrality adjustment.
Proposed New Behavioral Healthcare Services
The lengthy rule includes these proposals to improve payment for and access to behavioral healthcare services:
- For people determined to have elevated suicide or overdose risk, a new payment for safety planning interventions and post-discharge follow-up contacts;
- New digital tools payment for:
- Post-discharge telephonic follow-up;
- Software devices that treat a mental health condition in conjunction with ongoing treatment; and
- Extending evaluation and management services payment to allow clinical psychologists, clinical social workers, marriage and family therapists, and mental health counselors to conduct interprofessional consultations among themselves, as well with psychiatrists and other physicians.
Proposed Payment Updates by Specialty
Table 128 in the proposed rule lists these and other proposed updates by specialty:
- +3.0% for clinical psychologists;
- +1.0% for psychiatrists;
- +4.0% for clinical social workers;
- +1.0% for family practice physicians;
- +1.0% for internal medicine physicians; and
- No change for nurse practitioners.
Opioid Treatment Programs (OTPs)
Telehealth Extended for Methadone Treatment
Regarding methadone treatments, CMS proposes extending current telehealth flexibilities permanently for periodic assessments and initiation of treatment. For beneficiaries lacking permanent access to two-way audio-video communications technology, CMS would allow periodic assessments to be furnished via audio-only communications when applicable requirements are met. To support this proposal, CMS cites evidence that audio-only visits produce many of the same benefits as video-based visits. The rule also notes that this provision would advance the agency’s health equity goals.
For initiation of treatment with methadone for any new patient, audio-visual telehealth may be used if an OTP can conduct an adequate evaluation of the patient. Audio-only telehealth is not permitted. Such telehealth evaluations would use OTP intake add-on code (HCPCS code G2076) and must comply with the Drug Enforcement Administration, the Substance Abuse and Mental Health Services Administration (SAMHSA), and other requirements. These OTP provisions also are intended to align with SAMHSA’s goals for reducing barriers to access.
Payment for Patient Intakes
The rule proposes payment updates for intake activities (HCPCS code G2076) by OTPs, which align with recent SAMHSA reforms to advance patient-centered and evidence-based paradigms of care for Opioid Use Disorder (OUD) treatments such as harm-reduction interventions and recovery support services. Specifically, the rule would implement payment for social determinants of health risk assessments (HCPCS code G0136) to identify unmet health-related social needs or the need for OUD-related harm-reduction interventions and recovery support services. In addition, CMS seeks feedback on how OTPs currently coordinate care and make referrals to community-based organizations that address unmet Health Related Social Needs (HRSNs), provide harm-reduction services, and/or offer recovery support services.
Opioid Agonist and Antagonist Medications
CMS proposes to establish payment for new opioid agonist and antagonist medications that the U.S. Food and Drug Administration approved recently. Specifically, the rule would create a new add-on code to the bundled payment to reflect take-home supplies for nalmefene hydrochloride (nalmefene) nasal spray (Opvee®). The agency also proposes paying for a new extended-release injectable buprenorphine product (Brixadi®), indicated to treat moderate to severe OUD using a new weekly bundled payment code to reflect the weekly formulation of Brixadi®. In addition, the rule would update payment for the existing bundled payment for monthly injectable buprenorphine (HCPCS G2069) in order to reflect payment for the monthly formulation of Brixadi®. CMS’ goals for these changes are to help prevent additional opioid overdose deaths, reduce illicit opioid use, and retain more individuals with an OUD in treatment.
Billing Clarification
The rule also clarifies that for billing, an OUD diagnosis code is required on claims submitted under the Medicare OTP benefit, which helps ensure that payments for Part B OTP services are for the treatment of OUD.
Additional Telehealth Proposals
Permanent Expansion of Audio-only Telehealth
CMS proposes to permanently expand the allowable forms of telehealth “interactive telecommunications systems” to include audio-only communication technology if the patient is not capable of, or does not consent to, the use of video technology.
Temporary Telehealth Expansions
In addition, CMS is proposing temporary changes for the use of audio-visual (not audio-only) telehealth for the purpose of physician/practitioner supervision. Specifically, the rule would expand through CY 2025 the allowance for supervising practitioners to be “immediately available” through audio-visual telehealth. In addition, for CY 2025 only, teaching physicians could continue to supervise audio-visual telehealth services furnished by residents in all teaching settings, such as through a 3-way telehealth visit. Also for CY 2025, the agency will continue to permit physicians to use their currently enrolled practice location instead of their home address when providing telehealth services from home.
The rule also extends through CY 2025 the pandemic-originating coverage of telehealth services provided by federally qualified health centers and rural health clinics. This extension also includes the waiver allowing for reporting of enrolled practice addresses, rather than home addresses, when providers perform services from their home, and the waiver for virtual supervision for residents in all teaching settings when the services are provided virtually.
NABH is displeased that beginning Jan. 1, 2025 – in compliance with federal law – the rule repeals crucial telehealth flexibilities that would subject most digital care to pre-pandemic regulations.
Permanent Audio-visual Telehealth for Low-Risk Services
For services furnished after December 2025, CMS proposes that physician/practitioner oversight via audio-visual telehealth shall be limited to services that are “low risk by their nature, do not often demand in-person supervision, and are typically furnished entirely by the supervised personnel.” CMS’ stated goal for approving remote supervision for these particular low-risk services is that they already are known to balance patient safety concerns with the need to expand access and optimize workforce capacity:
- Services with the underlying HCPCS code that has been assigned a PC/TC indicator of ‘5’; and
- Services described by CPT code 99211 (Office or other outpatient visit for the evaluation and management of an established patient that may not require the presence of a physician or other qualified health care professional).
In addition to CMS’ proposed telehealth expansions, Congress is also considering extending telehealth flexibilities beyond this year, most likely through a two-year extension. NABH strongly endorses these flexibilities.
Quality
For reporting in 2025, CMS proposes six new, optional metrics for the quality payment program.
Please see the agency’s news release to read a high-level summary of the rule.
CMS will accept comments on the proposed rule through Sept. 9.
Reminder: SAMHSA Accepting Nominations for First SAMHSA Trailblazers in Advancing Recovery Awards
The Substance Abuse and Mental Health Services Administration (SAMHSA) announced this week it has started accepting nominations for the inaugural SAMHSA Trailblazers in Advancing Recovery (STAR) awards, which honor leaders with lived experience of mental health and/or substance use condition, including family members whose lives have been affected.
The new STAR awards will also recognize organizations that have demonstrated a commitment to promoting equitable and inclusive access to wellness and recovery supports for individuals with mental health and/or substance use conditions.
Last year SAMHSA published Recovery from Substance Use and Mental Health Problems Among Adults in the United States, which reports that more than 70% of people, or about 50 million people, identified as ever having a mental health and/or substance use problem were in recovery.
Nominations opened June 26 and will remain open through July 18. SAMHSA is planning an awards ceremony that it will livestream in September as part of National Recovery Month. Click here to learn about the award categories, eligibility requirements, and nominating process.
Reminder: SAMHSA Announces Funding Opportunity to Enhance Capacity of Women’s Behavioral Health Providers
SAMHSA is accepting applications for its Women’s Behavioral Health Technical Assistance Center to enhance capacity of women’s behavioral health providers, general healthcare providers, and others involved in the holistic care of women with or at risk for mental health and substance use conditions—including women who were greatly affected by the COVID-19 pandemic.
The agency said it has a total of $12.5 million for five years and anticipates granting one award. Applications are due by Tuesday, Aug. 20, 2024. Click here to learn more.
Reminder: ONC Funding Opportunity Seeks to Accelerate BHIT
HHS’ Office of the National Coordinator for Health Information Technology (ONC) last month announced a funding opportunity totaling $2 million for fiscal year 2024 under the Leading Edge Acceleration Projects (LEAP) in Health Information Technology (Health IT).
ONC is seeking applications that address two areas of interest. The first area seeks to develop innovative ways to evaluate and improve the quality of healthcare data used in artificial intelligence (AI) tools in healthcare to improve electronic health record technologies.
The second area is focused on designing, developing, and piloting lightweight health IT solutions that can enhance health IT capabilities in behavioral healthcare settings and improve care coordination between behavioral healthcare and clinical healthcare settings.
“These two areas of interest are a natural extension of ONC’s work,” Steve Posnack, deputy national coordinator for health information technology and an NABH 2024 Annual Meeting speaker, said in a statement. “We look forward to receiving innovative applications and seeing the impacts generated by selected awardees.”
Click here to learn more about the grant opportunity; ONC will accept applications through today, July 12, 2024.
Reminder: Please Submit Data to NABH’s Denial-of-Care Portal
We urge all NABH members to join those already submitting data to our Denial-of-Care Portal.
We are beginning to use aggregated portal data to illustrate and compare prior authorization practices for commercial, Medicare Advantage, and Medicaid managed care denials.
Policymakers have expressed particular interest in our aggregate estimate on days of uncompensated charity care, as well as the length of delayed health plan responses to prior-authorization requests.
To support this advocacy push, we strongly encourage all NABH members to submit data to the portal. Please contact NABH Associate Manager for Congressional Affair Emily Wilkins with questions about the data metrics that we are collecting and/or the data-submission process.
Fact of the Week
Results from a recent national survey showed 61% of Americans are unaware that primary care physicians can prescribe medication for opioid use disorder and 13% incorrectly believed that they could not, according to study published in JAMA.
For questions or comments about this CEO Update, please contact Jessica Zigmond.