NOTICE OF ADOPTIONTelehealth ServicesI.D. No. HLT-12-22-00003-AFiling No. 677Filing Date: 2022-08-29Effective Date: 2022-09-14PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following action:Action taken: Amendment of sections 505.17, 533.6; addition of Part 538 to Title 18 NYCRR.Statutory authority: Public Health Law, sections 2999-cc(2)(y), (4), 2999- ee, 201(1)(v); Social Services Law, section 365-aSubject: Telehealth Services.Purpose: To ensure continuity of care of telehealth services provided to Medicaid enrollees.Text or summary was published in the March 23, 2022 issue of the Regis- ter, I.D. No. HLT-12-22-00003-P.Final rule as compared with last published rule: No changes.Text of rule and any required statements and analyses may be obtained from: Katherine Ceroalo, DOH, Bureau of Program Counsel, Reg. Affairs Unit, Room 2438, ESP Tower Building, Albany, NY 12237, (518) 473- 7488, email: regsqna@health.ny.govInitial Review of RuleAs a rule that does not require a RFA, RAFA or JIS, this rule will be initially reviewed in the calendar year 2027, which is no later than the 5th year after the year in which this rule is being adopted.Assessment of Public CommentThe Department of Health (the "Department") received comments from several parties regarding proposed amendments to sections 505.17 and533.6of Title 18 (Social Services) of the Official Compilation of Codes, Rules and Regulations of the State of New York and the addition of Part 538, governing radiology and telehealth services. The comments and re- sponses are summarized below:COMMENT:Sixteen letters from federally qualified health centers (FQHCs) and af- filiates and associations representing FQHCs provided nearly identical comments supporting the Department's expansion of telehealth coverage in the proposed regulations and suggested the following reimbursement policies be added:Provide Full Reimbursement Parity, Regardless of Patient or Provider Location, for In Person, Audio-Only and Audio-Visual TelehealthThe commenters ask for payment parity, regardless of whether the provider and/or patient are located on-site. They state Medicaid reimburse- ment for Article 28 and Article16 clinics are based on the Ambulatory Patient Groups (APGs) which include a capital add-on. Most FQHCs are reimbursed via their Prospective Payment System (PPS) through three fee-for-service rate codes: a threshold rate, a lower offsite rate, and a group psychotherapy rate. They outline these bundled payment rates, and as dictated by Federal statute, are cost-based in nature. The FQHC offsite rate is not equivalent to the threshold rate minus a traditional facility fee. The offsite rate was created for FQHCs to provide care outside of the walls of the clinic. For Article 28 and Article 16 clinics, there is no offsite rate, and the APG rate minus the capital add-on is not equivalent to remov- ing a "facility fee."Furthermore, they explain all three clinic types continue to incur fixed personnel costs along with operation and maintenance of their physical sites and telehealth infrastructure regardless of provider and patient locations. As such, the offsite rate/removal of "facility fee" should not be deemed an appropriate reimbursement for any clinic service delivered via telehealth, even when both a patient and provider are offsite. Commenters ask for their APG or threshold rate for telehealth visits and express without it, clinics will experience workforce shortages and on-site constraints. With the increased need for behavioral health providers, remote options have been utilized to fill these gaps in staff and the space remote services creates has been used to meet medical demands.Ensure Consistency in Payment Across Licensure Types & Payment ModelsThe commenters state there should be no disparity between payment policy among Article 16, 28, or 31, licensed providers. Providers should receive their full APG or full threshold rate for all audiovisual and audio only telehealth visits just as they would for in person services, regardless of patient or provider location.Enable FQHCs to Bill for a Full Range of Telehealth ServicesThe commenters encourage the Department to add FQHC providers to the list of those who can bill for Remote Patient Monitoring (RPM) and the services under the expanded definition of telehealth included in the regulation (e.g., eConsults). The Department should accomplish this by al- lowing FQHCs to bill separately for the new modes of telehealth or by recalculating the costs in the bundled PPS rates to account for costs not currently captured under PPS.RESPONSE:The commenters' concerns regarding payment parity appear related to the 2023 NYS Enacted Budget amending Public Health Law (PHL) § 2999-dd(1) and not the proposed regulatory amendments. This regula- tory amendment is intended to provide authority for expansion of telehealth services. Once the regulations are finalized, the Department will provide additional telehealth policy and billing guidance. Furthermore, In- teragency workgroups are coordinating to align post-pandemic agency policies, to the extent possible, while supporting care for diverse populations with very different needs. Consistent with CMS rules, FQHCs that have not opted into APGs are currently not authorized to bill for Remote Patient Monitoring outside of the PPS rate. The increased demand for behavioral health services, workforce shortages, and clinic constraints, including billing rules for RPM, will be included in further internal policy discussions.COMMENT:ATA Action (the American Telemedicine Association's affiliated trade association) and Philips commented they support enactment of the proposed regulations and feel they have the potential to impact healthcare delivery. Both groups stress the need for coverage of remote fetal non- stress tests to support maternal health.RESPONSE:This regulatory amendment is intended to provide authority for expansion of telehealth services. Once the regulations are finalized, the Department will provide additional telehealth policy and billing guidance. The Department's Internal Review Benefit Committee (IBRC) will be charged with reviewing coverage of remote fetal non-stress tests.COMMENT:The New York State Association of County Health Officials (NYSA- CHO) and the 58 local health departments in New York State represented by NYSACHO, wrote in support of the proposed regulatory amendments by stating they allow for the continuity of care for Medicaid recipients receiving telehealth services after the current public health emergency ends. While recognizing certain barriers still exist, such as broadband ac- cess, these amendments ensure virtual service reimbursement and serve as a step forward in improving access to health care for those enrolled in Medicaid.RESPONSE:The Department appreciates the support of the NYSACHO and the 58 local health departments in New York State. Additionally, Department staff look forward to opportunities to coordinate with local health departments to identify any remaining barriers to telehealth services.COMMENT:A letter from Neurocrine Biosciences outlines concerns about audio- only telehealth replacing in-person care for behavioral health services. They strongly recommend that the Department (1) extend additional guidelines to Medicaid providers to ensure determinations of telehealth appropriateness align with existing standards of care for people living with serious mental illnesses, which recognize the most appropriate clinical approach will differ based on disease state; (2) consider including language that clearly recognizes that for some conditions, periodic, in- person encounters are necessary; and (3) support additional administrative action to evaluate the impact of audio-only reimbursement on patient- focused measures, especially underserved populations living with serious mental illnesses and drug-induced movement disorders.RESPONSE:New York State Medicaid providers are advised "audio-only" visits should only be used when in-person and audio-visual are not available or when audio-only is the patient's request. Furthermore, providers are advised they need to use the most appropriate mode of care for their patient. The Department plans to monitor audio-only services post-PHE for appropriateness. Both providers and members have expressed coverage for audio-only visits supports gaps in care and technological deficiencies.COMMENT:NYC Department of Health and Mental Hygiene (DOHMH) wrote stating they strongly support the Department's actions to permanently expand the modalities eligible for reimbursement, particularly the addition of audio-only visits. Telehealth is a critical tool for care delivery, supplementing in-person care by providing high-quality, convenient services without visiting a provider's office. They urge the Department to continue to prioritize equity in its approach to telehealth through robust data collection and dissemination, and sustained investments to close the digital divide. The commenter states the inclusion of audio-only telehealth services on a permanent basis will allow more New Yorkers to effectively communicate with their health care providers and reduce inequities. However, they also state audio-only telehealth services have serious limitations and are not appropriate for all patients or visit types. A visit that involves both an audio and visual connection facilitates more meaningful interactions, for which an audio-only connection is no substitute. There- fore, they recommend the Department collect and publicly release data on the use of various telehealth modalities to ensure providers are using audio-only modalities only as a last resort when audio-visual visits are not possible and when clinically appropriate, and not as a direct substitute for other virtual or in-person care. To ensure quality and accountability, they urge the Department to also develop a set of process or outcomes measures related to health equity in telehealth. They also ask the Department to work with other state agencies to increase access to, and affordability of, high-quality broadband and expand the scope of telehealth providers able to offer eConsults.RESPONSE:The Department appreciates the support of the NYC DOHMH and recognizes the need to prioritize equity through data collection. The Department is using surveys to measure provider and consumer engagement and experience with telehealth modalities. Regarding NYS DOHMH's concerns about audio-only telehealth, the Department agrees audio-only is not a direct substitute for audio-visual and in-person visits. Guidance to Medicaid providers conveys visits with a visual component are the preferred method and audio-only should be reserved for when an audiovisual visit is not an option. Additionally, interagency workgroups convene to discuss barriers and post-public health emergency (PHE) policies.COMMENT:The Adult Day Health Care Council (ADHCC) sent a letter with the following statements and recommendations:• We support the inclusion of the catch-all provision allowing any Medicaid provider to provide telehealth as long as services are appropri- ate;• Make the authority to offer telehealth services permanent;• Include audio-only telehealth to enable all individuals to utilize this care;• Modify the reimbursement of telehealth to ensure parity with in- person services and require MLTCs to reimburse at adequate levels; and,• Work with providers to develop billing codes that make sense for providers.They state their programs provide an interdisciplinary approach to care and are ideal telehealth providers. They know their registrants and can discern changes in their behavior and condition that result in immediate care and case management preventing more serious deleterious conditions. Many of their registrants suffer from chronic conditions such as diabetes, COPD, dementia, congestive heart failure, and asthma. Telehealth gives them the ability to provide necessary support and services to ADHCC's highly vulnerable registrants.RESPONSE:The Department is glad to hear this telehealth expansion will support the work ADHCC provides to their most vulnerable registrants. The regulatory amendments are intended to provide authority for permanent adoption of audio-only telehealth services and other modalities outlined in the proposal. Once the regulations are finalized, the Department will provide additional telehealth policy and billing guidance. While not the subject of this regulation, the 2023 NYS Enacted Budget amending PHL§2999-dd(1) includes a provision for payment parity that applies to all health plans, including MLTC plans.COMMENT:The Health Plan Association wrote to express where they see value in telehealth and where they have concerns. They state health plans are well- positioned to recognize the vital role telehealth plays in ensuring members are able to access the care they need and as an important tool to making health care more efficient. They agree telehealth reduces barriers to care and can expand access to services, but they have concerns telehealth will become a revenue maximizing opportunity with the potential to incentiv- ize unnecessary services. They express the focus should be on increasing access to broadband, technology/telehealth education, and what services they feel may not be appropriate for remote delivery (i.e., surgery, rheumatology, and ophthalmology). In particular, the Health Plan Associa- tion has concerns about the applicability of audio-only telehealth for Ap- plied Behavioral Analysis (ABA) therapy. They express because ABA ser- vices have a focus on how behaviors change, or are affected by the environment, as well as how learning takes place, it is vital that there be a visual assessment - at the very least - of the skills and actions that are needed to talk, play, and live. They also believe it's important to include telehealth in value-based payment (VBP) arrangements.RESPONSE:The Department agrees with the Health Plan Association's comments about the benefits of telehealth and the potential for abuse. Policies will reiterate that any service delivered via telehealth needs to be appropriately and effectively delivered remotely. As with all Medicaid services, claims are subject to monitoring and audit to identify fraud or misuse. Addition- ally, there is continued focus on training and educating medical staff and students on telehealth policies and best practices; DOH has partnered with the Northeast Telehealth Resource Center on a training portal for ongoing provider education on telehealth (www.nytelehealth.netrc.org).The Department agrees that Medicaid managed care plans and provid- ers should work on ways to bundle telehealth services into VBP contracts to incentivize ?exible use of telehealth as part of total cost of care, integrated primary care, and other population-or episode-based arrangements.