This NABH Issue Brief highlights changes to coverage for substance use disorder (SUD) treatment services that the Centers for Medicare & Medicaid Services (CMS) included in its 2021 Medicare Physician Fee Schedule (PFS) and other final rules. The PFS rule also contains many changes related to telehealth for substance use disorder (SUD) services. For a review of these modifications, please see NABH Issue Brief CMS Expands Medicare Telehealth Coverage for Mental Health and Addiction Treatment Services.

SECTION I: PFS and Other Rules

1. CMS adopted the proposal to expand the PFS bundled payments to include all SUDs, not just OUD treatment services.

• • To avoid duplicate billing for treating individuals who require treatment for more than one substance, HCPCS codes G2086-G2088 should not be billed more than once per month.

2. The agency adopted a new code to reimburse for medication assisted treatment (MAT) and additional services in the emergency department. The drug is paid for separately. There are no minimum number of minutes required. The following code was established for this purpose:

• • HCPCS code G2213: Initiation of medication to treat OUD in the emergency department setting, including assessment, referral to ongoing care, and arranging access to supportive services. (List separately in addition to code for primary procedure).

3. The Initial Preventive Physical Examination (IPPE) and Annual Wellness Visit (AWV) was modified to include a) screening for potential SUDs and b) review of any current opioid prescriptions. CMS adjusted the valuation of these services to reflect the changes in value for office/outpatient E/M visits to which they are cross-walked. 4. CMS finalized the proposal to make the Query of PDMP measure under the Electronic Prescribing objective for MIPS eligible clinicians an optional measure eligible for 10 bonus points in CY 2021, an increase of five points from last year.

SECTION II: Coverage for OUD Treatment Services in OTPs

Nasal Naloxone

1. CMS revised the definition of OUD treatment services to include short-acting opioid antagonist medications, such as naloxone, including nasal and injectable forms.

1. • CMS finalized the proposed drug costs of ASP+0 for nasal naloxone. CMS noted NABH’s concern related to pricing methodology for nasal naloxone and indicated it will monitor utilization of claims data to determine whether payment policies are suppressing naloxone access and need changes in future rulemaking.
   • Injectable naloxone is based on contractor pricing. CMS will monitor the data to determine typical dosages and national pricing in future rulemaking.

2. The agency revised its definition of OUD treatment services to include overdose education. The reimbursement rate for overdose education is $2.53. Payments are attached to the provision of naloxone (see Naloxone add-on codes below).

• • CMS will consider the need for independent coding for overdose education in future rulemaking.

3. Naloxone add-on codes consist of both a drug component and a non-drug component that would account for the provision of overdose education each time the OTP furnishes naloxone.

• • HCPCS G2215: Take-home supply of nasal naloxone (provision of the services by a Medicare-enrolled Opioid Treatment Program); list separately in addition to code for primary procedure.

Drug Cost	Non-Drug Cost	Total
89.63	2.53	92.16

1. • HCPCS G2216: Take-home supply of injectable naloxone (provision of the services by a Medicare-enrolled Opioid Treatment Program); list separately in addition to code for primary procedure.

Drug Cost	Non-Drug Cost	Total
Contracted Price	2.53	Contracted Price

  4. CMS noted that the brand and authorized generic formulation of the auto-injector naloxone have been discontinued. Therefore, an add-on code for auto-injector naloxone was not finalized. 5. The proposed frequency limit on Medicare payments to OTPs for naloxone was finalized at one add-on code (HCPCS code G2215 or G2216) every 30 days. 6. However, CMS noted NABH’s clinical concern about limiting naloxone and allowed for exceptions to the frequency limitation when it is a medically reasonable and necessary part of the treatment for OUD (e.g., when the beneficiary overdoses and uses the initial supply). Exceptions must be documented in the medical record. 7. CMS finalized its proposal to recoup duplicative payments of naloxone from the OTPs, based on the rationale that as coordinators of patient care, OTPs are best positioned to know whether naloxone is part of the OTP treatment plan or is supplied by another provider or supplier. 8. CMS finalized enrollment through use of Form CMS-855A (Medicare Enrollment Application for Institutional Providers) OR CMS-855B (Medicare Enrollment Application: Clinics/Group Practices and Certain Other Suppliers).

• • OTPs currently enrolled via CMS-855B may switch to enrollment via CMS-855A without an additional site visit and, if applicable, fingerprinting. This is also true if an OTP is currently enrolled under CMS 855-A and switches to CMS-855B.
  • The effective billing date that was established for the OTP under the original enrollment continues to apply.
  • Application fees still apply.

9. As proposed, CMS finalized that periodic assessments (add-on) via audio-visual technology require a face-to-face interaction.

• • • Therefore, periodic assessments are permitted to continue after the public health emergency ends but are not permitted to be performed via audio-only
    • Audio-only is permitted to be included as part of the bundled rate but not as an add-on code.
    • Periodic assessments are permitted when medically necessary and documented in the medical record.

10. CMS confirmed the permitted use of “standard billing cycles” in which episodes of care for all patients begin on the same day of the week and “weekly billing cycles” that vary across patients based on patient admission date (or when Medicare billing began). 11. CMS did not finalize its proposal to stratify the bundle.

• • CMS will consider refinements to account for resource variation for different service intensity, such as induction and maintenance periods.

Please click here for comprehensive information about billing and payment and here for comprehensive information about enrollment.

The Centers for Medicare & Medicaid Services (CMS) extended some Medicare coverage of telehealth services that the agency authorized during the Covid-19 pandemic. The changes were included in the final 2021 Medicare Physician Fee Schedule rule that was published in the Federal Register on Dec. 28, 2020. Extended Coverage of Certain Services CMS permanently extended Medicare coverage of the following services provided via telehealth:

• Home Visits, Established Patients (only for treatment of substance use disorders (SUDs) and co-occurring mental health disorder when less complex, lasting typically 25 minutes) (99347 & 99348),
• Group Psychotherapy (other than of a multiple-family group) (90853),
• Psychological and Neuropsychological Testing (96121),
• Care Planning for Patients with Cognitive Impairment (99483),
• Domiciliary, Rest Home, or Custodial Care services (99334),
• Domiciliary, Rest Home, or Custodial Care services (99335),
• Visit Complexity with certain office/outpatient evaluation and management services (G2211),
• Prolonged office or other outpatient evaluation and management service(s) (G2212), and
• New codes for the initial month or subsequent months of psychiatric collaborative care model services (G2214).

CMS also finalized a long list of telehealth services that are covered temporarily until the end of the calendar year in which the public health emergency (PHE) ends. Here are some examples:

• Home Visits, Established Patients (only for the treatment of substance use disorder or co-occurring mental health disorder when moderate to severe, typically lasting 60 minutes) (99349, 99350),
• Psychological and Neuropsychological Testing (96130- 96133, 96136- 96139),
• Therapy Services, Physical, and Occupational Therapy (97161-97168, 97110, 97112, 97116, 97535, 97750, 97755, 97760, 97761, 92521- 92524, 92507),
• Emergency Department Visits (99281-99285),
• Domiciliary, Rest Home, or Custodial Care services, Established patients (99336 & 99337),
• Initial Hospital Care and Hospital Discharge Day Management (99221-99223, 99238, 99239), and
• Subsequent Observation and Observation Discharge Day Management (99217, 99224-99226).

CMS said it intends these temporary extensions of coverage to allow time for the agency to consider whether these services should be extended permanently. Special Coverage of Mental Health and Substance Use Disorder Treatment via Telehealth This rule implements a change in the Medicare statute enacted in the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) authorizing Medicare coverage as of July 2019 of telehealth visits in a patient’s home (instead of a healthcare facility that qualifies as originating site) and regardless of whether the patient lives in a rural area, but only for treatment of substance use disorders (SUDs) and co-occurring mental illnesses. This final rule states that permanent Medicare coverage of home visits for treatment of SUDs and co-occurring mental health conditions is limited to established patients with less complex conditions. Medicare coverage of home visits via telehealth for moderate to severe SUDs or co-occurring mental illnesses will be covered temporarily until the end of the calendar year in which the PHE ends. CMS also finalized regulations allowing periodic assessments, which are part of opioid use disorder treatment services for opioid treatment programs, to be furnished via two-way interactive audio-video communication technology, as clinically appropriate, if all other applicable requirements are met. With a late-breaking addition, the FY 2021 Appropriations and Covid-19 Relief legislation enacted into law on Dec. 27, 2020 includes a provision authorizing Medicare coverage of mental health services via telehealth to beneficiaries in their homes regardless of geographic location. This provision adds mental health to the existing Medicare coverage authorized in the SUPPORT Act of telehealth services for beneficiaries in their homes, regardless of geographic location, to treat SUDs and co-occurring mental health conditions. The new law adds a requirement that a provider must have seen the beneficiary within six months before receiving the telehealth service to treat a mental health condition. The provision in the latest Covid-19 Relief legislation also states that the Health and Human Services (HHS) secretary may implement this section by interim final rule or “program instruction.” NABH will advise members when HHS takes action to implement the important provision. Coverage of Audio-only and Some Other Services Not Extended Medicare will no longer cover audio-only telehealth visits by physicians (99441-99443) and non-physician practitioners (98966-98968) after the PHE ends. CMS explained that its longstanding interpretation of the statutory provision that authorizes coverage of telehealth refers use of an “interactive telecommunication system” that CMS interprets to exclude audio-only technology. However, CMS did create a new code (G2252) to be used for coverage of longer virtual check-ins (11 to 20 minutes of medical discussion when the acuity of the patient’s problem is not likely necessary to warrant a visit, but the needs of the patient require more assessment time from the practitioner). This new code is valued at the same rate as 99442, whereas the pre-existing virtual check-in service (G2012) is valued at the rate of 99441. Telehealth visits will also no longer be covered for the initial visit with patients in skilled nursing facilities (SNFs) after the PHE. But CMS will allow more frequent subsequent SNF visits via telehealth, every 14 days instead of every 30 days. Continued Coverage of Telehealth Physician Supervision of Residents and Services “Incident To” Physicians’ Services CMS is continuing Medicare coverage of telehealth services delivered incident to the services of a billing professional until the later of the end of the year when the PHE ends or on Dec. 31, 2021. To bill Medicare, the supervising physician must be immediately available to intervene using live, two-way, audio-visual technology (e.g., a Zoom call with the patient, non-physician practitioner and physician). In addition, CMS will continue to cover services for residents who are supervised by physicians via telehealth until the end of the PHE. Teaching physicians must use real-time audio-visual technology. This coverage will be extended after the PHE only in rural areas. CMS clarified that Medicare will continue covering e-visits provided by licensed clinical social workers, clinical psychologists, (as well as physical therapists, occupational therapists, and speech-language pathologists) on a permanent basis. E-visits include brief online assessment and management services via telehealth as well as virtual check-ins and remote evaluation services. CMS has created two new codes for this expanded coverage:

• Brief communication technology-based service, e.g. virtual check-in, by a qualified healthcare professional who cannot report evaluation and management services, provided to an established patient, not originating from a related e/m service provided within the previous seven days nor leading to a service or procedure within the next 24 hours or soonest available appointment; 5-10 minutes of medical discussion (G2251); and

• Remote assessment of recorded video and/or images submitted by an established patient (e.g., store and forward), including interpretation with follow-up with the patient within 24 business hours, not originating from a related service provided within the previous seven days nor leading to a service or procedure within the next 24 hours or soonest available appointment (G2250).

DEA Eases Regulations for Mobile Methadone The Drug Enforcement Administration (DEA) on Feb. 26 proposed a regulation that revises the Controlled Substances Act (CSA) to permit narcotic treatment programs (NTPs)—opioid treatment programs, detoxification services that use methadone, and compounders— to operate mobile components, or mNTPs, without separate registrations. The rule also proposes requirements related to security, recordkeeping, reporting, and inventory. The purpose of the rulemaking is to address the opioid epidemic by expanding access to methadone treatment, especially for residents of rural and underserved communities. Background Currently, each mobile component of an NTP must be separately registered, as the components dispense narcotic drugs regularly and therefore constitute a “principal place of business” or a “professional practice.” The CSA permits waivers to this requirement in instances that serve public health. The DEA had provided waivers on an ad hoc basis until a moratorium was implemented in 2007; after that, there was a subsequent decline in the number of operational mobile components. The proposed rule obviates the need for ad hoc waivers by establishing mobile unit operations as a permissible “coincident activity” under the CSA with prior approval of a local DEA office. Selected Summary of Requirements

• Registration
  • Registrants notify the local DEA office in writing about intent to operate an mNTP and receive explicit written approval prior to operation.
  • The mNTP functions within the same states that the NTP is registered.
    • Practitioners maintain a DEA license in each state where they dispense controlled substances.
  • Vehicles possess valid county/city and state information on file at the NTP.
  • mNTPs are a controlled premise subject to administrative inspection; registrants provide licensing and registration to DEA at time of the inspection and before transportation of substances.
  • mNTPs may not serve as hospitals, long-term care facilities, emergency medical service vehicles, or patient transportation.

• Security
  • Storage area must not be accessible from the outside of the mNTP vehicle.
  • Substances are secured in a locked safe:
    • with safeguards against forced entry, lock manipulation, and radiological attacks;
    • cemented to the floor or wall such that it cannot be readily removed;
    • equipped with an alarm system that can directly signal a protection company, local or State policy agency, or 24-hour registrant-operated control station, or other DEA Administrator approved protection.
  • Transportation personnel retain control over the controlled substances when transferring, traveling, and dispensing the substances.
  • mNTP is returned to registration location after operations are completed.
    • Substances are removed and secured within the registered NTP location.
    • Protocols allow for securing substances if the component is disabled.
    • Substances are removed and secured if the vehicle is taken to an automotive shop for repair.
  • For security breaches such as theft and loss, the NTP must abide by theft and loss reporting requirements.
  • NTPs follow state and federal regulations or whichever is more stringent and consults with State Opioid Treatment Authority to ensure compliance.

• Other security controls
  • Ensure proper security measures and patient dosage, e.g., enrolled individuals wait in an area of the mNTP that is physically separated from the narcotic storage and dispensing area by a physical entrance.
    • If no seating is available, patient will wait outside of the mNTP.
  • mNTPs will abide by existing HHS standards for quantity of substances provided for unsupervised use.
  • Degree of security is at DEA discretion, based on factors including the location, number of patients, staff, and security guard.
  • Disposal of controlled substances is done consistent with all applicable laws and regulations.
  • Distribution and delivery of controlled substances to mNTP is only done at the registered location. Persons delivering narcotic drugs to mNTP may not:
    • Receive or deliver controlled substances to another mNTP or other entity while deployed outside the registered location.
    • Act as reverse distributors (or collectors).

• Records and Reports
  • mNTP records are maintained in a paper dispensing log at the registered NTP, or
  • Use of automated/computerized system if the system:
    • maintains the same information as required for paper records;
    • has the capability to produce hard copies of the dispensing records;
    • the mNTP prints each day’s dispensing log which is initialed by individuals who dispense the medication;
    • produces accurate summary reports for any time frame requested by DEA in an investigation;
    • Hard copies of summaries are systematically organized at the NTP;
    • Computer generated information has off-site back-up;
    • DEA approves of the system.
  • mNTP maintain records for two years, or longer if required by the state.

Please contact Sarah Wattenberg, NABH’s director of quality and addiction services, at sarah@nabh.org, or 202.393.6700, ext. 114.