Medicare Physician Fee Schedule Proposal for CY2023 Provisions

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The Medicare Physician Fee Schedule (PFS) outlines the payment framework for Medicare Part B services. Each year, CMS proposes changes in an NPRM, allowing stakeholders to comment. Key aspects include telehealth extensions and flexibilities during COVID-19. The PFS rulemaking process leads to final rule issuance in late fall, incorporating feedback from stakeholders.

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Medicare Physician Fee Schedule Proposal for CY2023 Provisions of Interest to NCMW Members Susannah Vance Gopalan Feldesman Tucker Leifer Fidell LLP September 20, 2022

The Medicare Physician Fee Schedule Rulemaking The Physician Fee Schedule (PFS) is the coverage / payment framework under which Medicare pays for many services rendered by Medicare Part B physicians and non-physician practitioners and groups Each year, typically in the summer, the Centers for Medicare & Medicaid Services (CMS) publishes in the Federal Register a wide-ranging Notice of Proposed Rulemaking (NPRM) explaining the changes CMS intends to make in the subsequent year in coverage / payment under the PFS Stakeholders then have an opportunity to comment on the NPRM (comments were due September 6, 2022) The Medicare CY2023 NPRM can be accessed here CMS will issue a Final Rule (late fall) where CMS announces the final changes to the rules for CY2023 and explains how CMS addressed specific comments on the NPRM

Telehealth Extensions

Medicare Telehealth Services Hub Hub- -and site ( spoke ) Key requirements: Key requirements: Distant site provider Distant site provider must be a physician or practitioner who bills for services under the Physician Fee Schedule must be a physician or practitioner who bills for services under the Physician Fee Schedule(42 C.F.R. 410.78(b)) Distant site fee corresponds to Physician Fee Schedule rate for in-person service Telecommunications system Telecommunications system requirements regulations in effect until 1/1/22 required Medicare telehealth to involve synchronous audiovisual synchronous audiovisual technology (42 C.F.R. 410.78(a)(3)) The regulations were amended effective 1/1/22 to allow audio-only technology to be used for mental health telehealth services under certain conditions Covered telehealth services Covered telehealth services must correspond to a CPT/HCPCS code included on a CMS list of covered telehealth services (https://www.cms.gov/files/zip/covid-19-telehealth-services-phe.zip) Originating site Originating site generally, the patient must be located in a facility of a type listed in the statute, and the facility must be in a remote/rural location, under standards set forth in the law and- -spoke model spoke model: Physician or practitioner located at distant site ( hub ) furnishes care to a patient located at an originating

Telehealth Flexibilities During COVID-19 PHE CMS has recognized, through waivers under Section 1135 of the Social Security Act, numerous flexibilities in delivering teleh CMS has recognized, through waivers under Section 1135 of the Social Security Act, numerous flexibilities in delivering teleheal (waiver applies to services rendered on/after 3/1/20, and through the end of the PHE): (waiver applies to services rendered on/after 3/1/20, and through the end of the PHE): Practitioner restrictions: Practitioner restrictions: Rather than telehealth delivery being limited to the physicians and practitioners listed in the law, any health care clinicians who are eligible to bill Medicare for their professional services may serve as a telehealth distant site provider (COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers) Location of clinician: Location of clinician: Clinicians furnishing telehealth services may be located in their homes (or other locations other than the facility) may bill for telehealth services Service array: Service array: CMS has dramatically increased the number of covered telehealth services on a temporary basis during COVID-19 Covered Telehealth Services for PHE for the COVID-19 pandemic, effective March 1, 2020 - Updated 01/05/2022 (ZIP) Telecommunications system Telecommunications system For purposes of some services, CMS waived the application of a regulatory requirement that telehealth be provided via audiovisual technology (allowed audio-only telehealth delivery for certain specific codes) Originating site requirements Originating site requirements CMS has waived the application of all originating site requirements during the PHE (including both geographic component and facility component) There is no originating site facility fee available for services where the patient is not located in a qualifying originating site facility ealth th

Congress Acts To Allow Mental Health / SUD Telehealth To Be Provided to Patients at Home Separate from the pandemic Separate from the pandemic- -related changes in the law, Congress enacted legislation sequentially in 2018 related changes in the law, Congress enacted legislation sequentially in 2018- -2021 that waived the originating site requirements for some telehealth services, including mental health / SUD related services, subject to variou originating site requirements for some telehealth services, including mental health / SUD related services, subject to various s restrictions. restrictions. Per the SUPPORT for Patients and Communities Act of 2018, for purposes of telehealth services furnished on/after July 1, 2019 to an individual with an SUD disorder an individual with an SUD disorder, for treatment of the SUD disorder or a co-occurring mental health disorder, the geographic component of the originating site requirements does not apply, and the patient s home is an acceptable originating site Per the Consolidated Appropriations Act 2021, purposes of telehealth services furnished on/after the end of the COVID telehealth services furnished on/after the end of the COVID- -19 PHE for purposes of treatment of mental health disorders generally purposes of treatment of mental health disorders generally, the geographic component of the originating site rules is waived, and the patient s home is an acceptable originating site, except that the distant site physician or practitioner must have treated the patient in-person within the six-month period before the furnishing of the telehealth service, and At periodic intervals thereafter (CMS elected 12 months) 2021 that waived the telehealth services furnished on/after July 1, 2019 to 19 PHE for See 42 C.F.R. 410.78(b)(3)(ix) (implementing regulation)

Definition of the Home of the Patient for Purposes of Telehealth CMS clarified in the CY2022 Physician Fee Schedule rulemaking: Our definition of home, both in general and for this purpose, can include temporary lodging, such as hotels and homeless shelters. We clarify that for circumstances where the patient, for privacy or other personal reasons, chooses to travel a short distance from the exact home location during a telehealth service, the service is still considered to be furnished `in the home of an individual' for purposes of section 1834(m)(4)(C)(ii)(X) of the Act. 86 Fed. Reg. at 65059 (Nov. 19, 2021)

CMS Amends Telehealth Regulations Permanently To Allow Audio-Only Mental Health Telehealth Visits Effective January 1, 2022: Interactive telecommunications system Interactive telecommunications systemmeans, except as otherwise provided in this paragraph, multimedia communications equipment that includes, at a minimum, audio and video equipment permitting two-way, real-time interactive communication between the patient and distant site physician or practitioner. For services furnished for purposes of diagnosis, evaluation, or treatment of a mental health disorder to a patient in their home, interactive purposes of diagnosis, evaluation, or treatment of a mental health disorder to a patient in their home, interactive telecommunications may include two telecommunications may include two- -way, real way, real- -time audio time audio- -only communication technology if the distant site physician or only communication technology if the distant site physician or practitioner is technically capable to use an interactive telecommunications system as defined in the previous sentence, practitioner is technically capable to use an interactive telecommunications system as defined in the previous sentence, but the patient is not capable of, or does not consent to, the use of video technology. but the patient is not capable of, or does not consent to, the use of video technology. A modifier designated by CMS must be appended to the claim for services described in this paragraph to verify that these conditions have been met. 42 C.F.R. 410.78(a)(3) (emphasis added) For services furnished for Note Note: The audio-only exception relates only to mental health-related services, not to substance use disorder services.

Telehealth Extensions CAA 2022 In In Consolidated Appropriations Act, 2022 Consolidated Appropriations Act, 2022 (Mar. 15, 2022), Congress extended the application of various Medicare telehealth flexibilities (Mar. 15, 2022), Congress extended the application of various Medicare telehealth flexibilities (and postponed the application of some requirements) in order to ease the transition away from the PHE: (and postponed the application of some requirements) in order to ease the transition away from the PHE: Delayed the application of the in-person prerequisites for waiver of the originating site requirements for mental health telehealth services, contained in CAA 2021, until the 152ndday after the close of the PHE Extended until the 151stday after the close of the PHE, the following temporary authorities: The waiver allowing originating site to mean any site in the United States at which the eligible telehealth individual is located . . . Including the home of an individual (and specifying that no originating site facility fee is available for telehealth services to patients at locations other than facilities) Expansion of the term practitioners to include occupational therapists, physical therapists, and speech language pathologists The recognition of audio-only telehealth services (to include any HCPCS codes for which, effective 5/15/22, HHS had recognized a waiver of the requirement of audiovisual communication) Note: This last allowance is of limited relevance to providers that primarily furnish mental health services, as CMS permanent amendment of the telehealth regulations effective in CY2022 independently allowed continuing (indefinite) recognition of audio-only mental health services

CMS Implementation of CAA, 2022 Telehealth Extensions Given that the end date of the PHE is not yet known and could occur before the rulemaking process for the CY 2023 PFS is complete, and that the changes made by these provisions are very specific and concise, we are providing notice that we intend to issue program instructions or other subregulatory guidance to effectuate the changes described above, other than the proposed revisions to 410.78, in the near future. We believe this approach will serve to ensure a smooth transition after the end of the PHE for COVID-19. 87 Fed. Reg. at 45,899 (July 29, 2022)

Incident to Services

The Incident-To Concept Physician s / practitioner s core service Incident-to supplies Incident-to services furnished by auxiliary auxiliary personnel personnel

Incident to Services - Terminology Physician or practitioner (supervising / billing provider) Physician or practitioner (supervising / billing provider) means a physician or any practitioner who is explicitly authorized under the Medicare statute to receive payment for services incident to his or her own services Examples of qualifying non-physician practitioners: clinical psychologist (42 CFR 410.71), physician assistant (42 CFR 410.74), nurse practitioner (42 CFR 410.75), clinical nurse specialist (42 CFR 410.76), and certified nurse midwife (42 CFR 410.77). Does not include clinical social workers Auxiliary personnel Auxiliary personnel (individual performing incident-to service) means any individual who is acting under the supervision of a physician (or other practitioner), regardless of whether the individual is an employee, leased employee, or independent contractor of the physician (or other practitioner) or of the same entity that employs or contracts with the physician (or other practitioner), has not been excluded from the Medicare, Medicaid and all other federally funded health care programs by the Office of Inspector General or had his or her Medicare enrollment revoked, and meets any applicable requirements to provide incident to services, including licensure, imposed by the State in which the services are being furnished. 42 CFR 410.26(a)(1); CMS, Local Coverage Article,Psychological Services Coverage under the Incident to Provisions for Physicians and Non-Physicians (A52825) (rev. 1/1/17)

Criteria for Incident to Services Services must be provided in a noninstitutional setting and to noninstitutional patients Services and supplies must be an integral, though incidental, part of the service of a physician/practitioner in course of diagnosis or treatment of an injury or illness Services and supplies must be commonly furnished without charge or included in the bill of the physician/practitioner Services and supplies must be of a type that are commonly furnished in the office or clinic of a physician or practitioner In general, services and supplies must be furnished under the direct supervision under the direct supervision of the physician (or other practitioner) [exception: designated care management services] The physician (or other practitioner) supervising the auxiliary personnel need not be the same physician (or other practitioner) who is treating the patient more broadly. However, only the supervising physician (or other practitioner) may bill Medicare for incident to services. Services and supplies must be furnished by the physician, practitioner with an incident to benefit, or auxiliary personnel Services and supplies must be furnished in accordance with applicable State law 42 C.F.R. 410.26

CMS Proposal in CY2023 PFS Incident to Services [W]e are proposing to amend the direct supervision requirement under our incident to regulation at 410.26 to allow behavioral health services to be furnished under the general supervision of a physician or NPP when these services or supplies are provided by auxiliary personnel incident to the services of a physician or NPP. We are limiting the scope of this proposal to behavioral health services at this time due to increased needs for behavioral health treatment and workforce shortages in this field. We believe that this proposed change will facilitate utilization and extend the reach of behavioral health services. Stated purpose was to improve access to and quality of mental health services by helping to reduce existing barriers and make greater use of the services of LPCs and LMFTs This was the boldest action CMS could take on this issue, as it does not have regulatory authority to create new billable practitioner types One unanswered question is how CMS plans to define the scope of behavioral health services subject to this relaxed standard 87 Fed. Reg. 45938 (July 27, 2022)

General vs Direct Supervision General supervision General supervision means the service is furnished under the physician's (or other practitioner's) overall direction and control, but the physician's (or other practitioner's) presence is not required during the performance of the service. The training of the auxiliary personnel who actually perform the service/procedure and the maintenance of the equipment and supplies are the continuing responsibility of the physician/practitioner. Direct supervision Direct supervision in the office setting means the physician (or other supervising practitioner) must be present in the office suite and immediately available to furnish assistance and direction throughout the performance of the procedure. It does not mean that the physician (or other supervising practitioner) must be present in the room when the procedure is performed. Until the later of the end of the calendar year in which the PHE as defined in 400.200 of this chapter ends or, December 31, 2021, the presence of the physician (or other practitioner) includes virtual presence through audio/video real-time communications technology (excluding audio-only). Note Note virtual direct supervision virtual direct supervision: CMS noted in the PFS proposal that after the end of the calendar year when the PHE ends, direct supervision may no longer be carried out via telecommunications. CMS sought comment on this issue. 42 CFR 410.26(a)(2)-(3); 42 CFR 410.32(b)(3)(ii); CMS, Medicare Benefit Policy Manual, Chapter 15, Sections 60.2 and 80

Proposals Involving Opioid Treatment Programs (OTPs) CMS proposed in the CY2023 PFS to allow OTPs to seek Medicare payment for services furnished by mobile units. Services provided by OTP mobile units will be included in the OTP bundled payment codes so long as medically reasonable and necessary. CMS proposed to allow the initiation of treatment with buprenorphine via two-way/audio-video modality, as well as audio-only modality when two-way/audio-video is not available to the patient (such as in circumstances where the patient does not have the capability or has not consented to two-way/audio-video technology) CMS also requested comment on whether it should allow periodic treatment via audio-only technology after the PHE ends for treatment services with buprenorphine as well as for methadone and naltrexone.