RIN 0938-AS06 Medicare Program: Medicare Shared Savings Program: Accountable Care Organizations Proposed Rule December 8, 2014

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1 February 6, 2015 Ms. Marilyn Tavenner Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Hubert H. Humphrey Building, Room 445-G 200 Independence Avenue, SW Washington, DC Reference: File code CMS 1461-P RIN 0938-AS06 Medicare Program: Medicare Shared Savings Program: Accountable Care Organizations Proposed Rule December 8, 2014 Dear Ms. Tavenner: American Telemedicine Association (ATA) appreciates this opportunity to provide comments and recommendations regarding the Medicare Shared Savings Program: Accountable Care Organizations Proposed Rule. We applaud CMS s decision to consider waiving the statutory restrictions for telehealth services under Medicare Parts A and B as authorized under Social Security Act section 1834(m) and interest in soliciting public comment on billing and payment of telehealth-provided covered services in ACOs. Expanding the use of telehealth services and modern technologies will be an important step forward in improving Medicare beneficiaries access to quality and cost effective care delivery systems. There is growing recognition among policy makers at the state and federal level that telehealth and related services are particularly relevant in addressing the consequences of health professional shortages, maldistribution, and provider participation in both private insurance, Medicaid and the Medicare program. Despite decades of efforts to entice health professionals to locate in or near underserved areas, the problems have generally gotten worse. The tools of telehealth, notably real-time and interactive video visits, can be of immediate benefit to Medicare beneficiaries, ACOs, health plans and professionals. Currently, Medicare is failing its beneficiaries by its very restrictive rules concerning telehealth, such as the following: Requiring that a beneficiary with severe depression and other mobility-impairing conditions must leave their home and travel to get mental health counseling, Page 1 of 12

2 Not covering a beneficiary in a metropolitan area for getting a time-critical diagnosis of an ischemic stroke so that disability-preventing clot busting medication can be administered merely because the stroke specialist is at a different location, Not covering a beneficiary who meets Medicare s definition of homebound from receiving any health care services from a physician using video, Requiring that a beneficiary needing physical rehabilitation must be at an inpatient facility or travel to an outpatient facility for all therapy services, Not covering a beneficiary receiving hospice services at home from receiving pain management or counseling from a physician using video, Not covering a beneficiary at-risk with multiple chronic conditions to have key health indicators monitored daily from their home, and Requiring that a beneficiary with diabetes travel to a scarce retinal specialist for an annual diabetic retinopathy exam to prevent blindness. We have no doubt that paying for telehealth within an ACO will increase the net savings from ACOs for the Medicare program. Paying for telehealth within an ACO will be the single most important step to date by CMS to advance the knowledge and experience of how best to use these technology tools. Using telehealth is how ACO providers can create value. States have been major innovators in using telehealth to implement health delivery reforms that achieve significant cost savings and improve health outcomes. ATA has been instrumental in the development and passage of these reforms, providing education, outreach and engagement for key stakeholders at the state level. Twenty-two states and the District of Columbia have telehealth parity insurance laws for health benefit plans to treat telehealth covered services comparably with in-person services. Several state Medicaid plans have also moved to full parity. For example, last year Tennessee enacted telehealth parity for private insurance, Medicaid and state employee benefits. In implementing the Affordable Care Act (ACA), CMS has taken position that telehealth is a way to provide a service rather than a unique service per se in implementing the essential health benefits (EHB) provision for health insurance marketplaces. More pertinent and significant is that a Congressional committee has out for discussion a bill that would basically waive the restriction of 1834(m) for ACOs and other Medicare demonstrations and models. General Comments: Support ACO flexibility from Medicare telehealth restrictions: ATA strongly supports allowing ACOs flexibility from the Medicare telehealth restrictions in Social Security Act section 1834(m). ACOs participating in the Medicare Shared Savings programs, with their financial and operational incentives, can be prudent demonstrators of the best uses of telehealth tools. For this reason, we find the current restrictions of 1834(m) particularly inappropriate for such Medicare services. We urge that ACOs be given the same flexibility to cover telehealth as has been the long-standing policy for Medicare Advantage plans. From the perspective of wanting to attract participants in the ACO program, being able to offer less restricted telehealth can be a reward and a competitive advantage. Page 2 of 12

3 In particular, we support a general waiver from the restrictions of 1834(m) for ACOs by the Secretary under section 1899(f). We support an ACO using the application process to describe their telehealth and related services, up to any applicable Medicare coverage limitations. We urge CMS not to create and operate a waiver approval process for the use of telehealth by each individual ACO applicant. Support telehealth parity in-person services where medically appropriate: Although parity should be the baseline, there are opportunities with emerging technology and innovative applications to create new forms of care, such as remote patient monitoring of chronic conditions. Our goal is to remove artificial policy barriers to telehealth provided services that are Medicare covered services, in other words parity with in-person services. Parity for telehealth is increasingly common with almost half of the states enacting such laws but Medicare is becoming a lone standout with several formidable barriers in the way. Support comparable regulatory requirements: ATA supports applying the same regulatory oversight to telehealth and related services that is required of the other similar components of care coordination and ACO operations. The ACO design and financial incentive structure encourages and promotes use of enabling technologies that create value to the care delivery system and contains the governance, infrastructure and necessary provider oversight to protect Medicare and beneficiaries from fraud and abuse. It is unnecessary and counter-productive to have special operational and data requirements that single out telehealth services and create burdensome regulatory requirements that will stifle innovation and discourage participation by ACOs. General guidance on regulatory requirements in the proposed rule: Mindful of CMS longstanding views and concerns, we suggest a phase-in of telehealth flexibility, including remote patient monitoring, for ACOs based on the entities financial risk and beneficiary management: Year 1, for Track 3 plans Medicare should pay for telehealth-provided covered services, in addition to the coverages of 1834(m), accordingly to a plan s standard description in its application Year 2, add Track 2 plans Year 3, add Track 1 plans. Such phasing will also allow newer ACOs to learn from the experience of the more advanced, more at-risk ACOs. This will also allow CMS to develop appropriate telehealth provisions. Page 3 of 12

4 Specific Comments and Recommendations: ATA appreciates this opportunity to provide comments and recommendations on the areas of concern and questions raised in the proposed rule. For purposes of this section we have used bold text for CMS language and plain text for ATA comments. II. Provisions of This Proposed Rule. b. Proposed Revisions 8. Required Processes To Coordinate Care c. Proposed Revisions (Page 72779) We propose to add a new requirement to the eligibility requirements under (b)(4)(ii)(C) which would require an ACO to describe in its application how it will encourage and promote the use of enabling technologies for improving care coordination for beneficiaries. ATA strongly supports encouraging the use of enabling technologies, including telehealth to improve care coordination for beneficiaries participating in ACOs. However, adding a specific eligibility requirement as part of the application process may reduce interest in exploring innovative enabling technologies and requires these technologies to meet different requirements than those imposed on other elements of care coordination. Enabling technologies should be considered one of the components of care coordination and be treated the same way as a description of nurse advice or population health programs or other components of care coordination are treated in the application. As a result, we do not support a separate new eligibility requirement for enabling technologies. We also note that ACOs have the flexibility to use telehealth services as they deem appropriate for their efforts to improve care and avoid unnecessary costs. Some ACOs have already reported that they are actively using telehealth services to improve care for their beneficiaries. ATA is pleased that CMS recognizes the value of ACOs having flexibility to provide telehealth services as they deem appropriate and is interested in allowing waivers from the Medicare section 1834(m) provisions. Flexibility from section 1834(m) has been a long standing policy for Medicare Advantage plans and giving ACOs this same flexibility is very appropriate. It is critical that any ACO requirements encourage participation, support innovation and do not create undue burdens that stifle flexibility. A waiver from section 1834(m) would be a significant policy change that would go a long way in providing ACOs with needed flexibility to provide telehealth services where medically necessary and appropriate. Page 4 of 12

5 We welcome information from ACOs and other stakeholders about the use of such technologies. We seek comment on the specific services and functions of this technology that might be appropriately adopted by ACOs. For example, do the use of telehealth services and other technologies necessitate any additional protections for beneficiaries? Beneficiaries already have a number of protections in place when telehealth services are provided through an ACO entity. The telehealth services will be rendered by ACO professionals, ACO providers/suppliers or hospitals under contract with the ACO entity and will be required to meet the quality, credentialing and other participation requirements to be in the ACO and provide health care services to beneficiaries. The ACO governing body also has responsibility for assuring only medically necessary care is rendered and the ACO structure provides protection against fraud and abuse opportunities. ACOs provide similar beneficiary protections to those available in Medicare Advantage plans. Beneficiaries can also choose to receive or not receive telehealth services which are an additional protection for beneficiaries. Are these technologies necessary for care coordination or could other methods be used for care coordination? Telehealth services play a key role in facilitating care coordination and providing access to needed services. For example, the expertise of an specialty physician or more timely access to care by allowing a radiologist or other provider to review a patient medical information that has been transmitted from an originating site to the physician at a distant site. Other methods cannot facilitate this timely access to care or centers of excellence, particularly in areas with shortages of health professionals and facilities. If a particular technology is necessary, under what circumstances? Telehealth services are necessary in a number of circumstances: Triaging for faster, appropriate specialist care Increasing provider productivity Relief for provider shortages Reduction in disparities to patient access Decreasing unnecessary variations in care Reducing in-person overuse, such as in emergency rooms and preventable inpatient admissions Page 5 of 12

6 F. Shared Savings and Losses Seeking Comment on Ways to Encourage ACOs Participating in Performance-Based Risk Arrangements (Pages ) (2) Billing and Payment for Telehealth Services Describes current payment for telehealth services rendered by a physician or practitioner under certain conditions. (Page 72820) The discussion of billing and payment for telehealth services notes that technologies like telehealth are being increasingly used to complement face-to-face patient-provider encounters in both urban and rural areas. It also states ACOs and other commenters have suggested that a waiver of certain Medicare telemedicine payment requirement would help encourage a broader range of ACO to more fully utilize telehealth, remote patient monitoring, and other such enabling technologies. ATA strongly supports a waiver for ACOs from the following specific, otherwise artificial Medicare restrictions in section 1834(m), up to any overall Medicare coverage limitations: Section 1834(m)(4)(C)(I)(II) to permit an ACO to provide health services by video conferencing for Medicare beneficiaries who live in metropolitan counties. The last sentence of section 1834(m)(1) to permit an ACO to provide and bill for health services provided by store-and-forward means (such as transmission of medical images) to beneficiaries who live outside of an Alaska or Hawaii demonstration site as of December 31, Section 1834(m)(4)(F)(i) to permit an ACO to provide additional CPT and HCPCS codes for Medicare covered services provided via telehealth. Section 1834(m)(4)(C)(ii) to permit an ACO to provide for telehealth services originating from a beneficiary s home, a hospice and anywhere else from which a beneficiary seeks service (without regard to an originating site fee). Section 1834(m)(4)(E) to permit a beneficiary in an ACO to get the otherwise covered Medicare services of physical therapy, occupational therapy, speech-language pathology, audiology and other health professionals. If ACOs receive waivers from these five specific Medicare restrictions, they can take the lead in demonstrating the value of telehealth remote patient monitoring and other technologies in innovating care delivery and improving access and efficient delivery of care in both rural and urban settings. The ACO quality and performance measures and other participation requirements provide protection against fraud and abuse and Medicare s traditional fee for service utilization controls. Additionally, an ACO should have the flexibility to provide other telehealth services, such as remote patient monitoring for beneficiaries with at-risk chronic conditions. An ACO should be able provide remote patient monitoring and home-based video conferencing services in connection with the provision of home health services (under conditions for which payment for such services would not be made under section 1895 for such services) in a manner that is financially equivalent to the furnishing of a home health visit. Page 6 of 12

7 A waiver of certain Medicare telehealth requirements could be supported by section 1899(b)(2)(G) of the Act in that it gives the use of enabling technologies, such as telehealth, as an example of a process to coordinate care, and the statute does not limit ACOs to being in rural or shortage areas where Medicare payment is available for telehealth services. As indicated regarding section II.B.8.a., we welcome information from ACOs and other stakeholders about the use of such technologies to coordinate care for assigned beneficiaries. (Page 72821) The Medicare restrictions on telehealth are related to the provision of care, not the coordination of care. For coordination of care, a key would be interoperable, universal, robust and longitudinal electronic health records. For purposes of advancing the population health objectives of the ACOs, we recommend that CMS set and pay using relative value units for online evaluation and management services, CPT codes and 99444, for services provided by ACO professionals. For ACOs, CMS should fix a Catch 22 Medicare recertification requirement by allowing home-based video to be used for beneficiaries and physicians to comply with the recertification requirements for home health and durable medical equipment for Medicare and Medicaid imposed by the Affordable Care Act section The Congressional drafters seemingly intended that video visits could be a way to comply because of their reference to 1834(m), but overlooking the nullifying provision that a telehealth originating site cannot be a beneficiary s home. For Medicare home health patients, this is a Catch 22 because they need to homebound. Page 7 of 12

8 If we were to implement a waiver then we believe it would be appropriate to limit the use of such waivers to beneficiaries that are assigned to the ACO during the applicable performance year. We believe this would be best accomplished by permitting ACOs to use these waivers when they have a prospectively assigned population. In other words, the waivers would be limited to ACOs participating in Track 3. Prospectively assigned beneficiaries under Track 3 would be assigned to the ACO for the entire year and it would thus be clear to ACOs and CMS as to the beneficiaries for which a waiver applied. As mentioned previously, we believe a prospective assignment approach creates a potential pathway for improving the appropriate use of waivers by ACOs and a method for CMS to monitor its use. In addition, under Track 3 there would be greater opportunity for risk. Mindful of CMS longstanding views and concerns, we suggest a phase-in of telehealth flexibility, including remote patient monitoring, for ACOs based on the entities financial risk and beneficiary management: Year 1, for Track 3 plans Medicare should pay for telehealth services, in addition to the coverages of 1834(m), accordingly to an ACO plan s standard description in its application Year 2, add Track 2 plans Year 3, add Track 1 plans. For year 1, ATA supports limiting use of the waivers to prospectively assigned ACO beneficiaries for an entire performance year to demonstrate the value and measure the quality and cost impact of telehealth services. Additionally, since Medicare will be paying an ACO professional, ACO providers/suppliers and hospitals providing a telehealth service based on their location and some ACOs serve beneficiaries in more than one state, we request that CMS allow health professionals and facilities participating in an ACO to be licensed at their location. For these reasons, we believe that Track 3 is potentially a better candidate for such a waiver than Track 2. However, we seek comment on whether these waivers should apply to all two-sided performance-based risk tracks. ATA also supports a phased approach to implementing the waivers. We share CMS s view that the Track 3 is a better candidate for the waiver. As noted in our earlier response, we recommend adding Track 2 ACOs in Year 2. In the spirit of innovation and flexibility, if a particular Track 2 ACO is interested in pursuing a waiver, we believe CMS should evaluate the Track 2 ACO and make a determination based on their ability to meet the performance requirements. Page 8 of 12

9 Another option would be for the waivers would apply to any FFS beneficiary cared for by an ACO and then the waiver could be available to ACOs participants. A general waiver should allow an ACO to describe in its application its intended application. Another option would be to apply such waivers to beneficiaries that appear on the quarterly lists of preliminarily prospectively assigned beneficiaries. Under this approach, the population for whom the waiver is available would likely change from quarter to quarter. Quarterly enrollment is too short to demonstrate value, performance and cost savings. ATA supports limiting the waivers to prospectively assigned ACO beneficiaries for a performance year. Under a waiver of the telehealth requirements, we would anticipate establishing additional requirements to ensure program transparency and help reduce the possibility for abuse of the part of its application for the waiver. ATA supports transparency about the waiver for telehealth and other ACO program activities. As noted earlier, beneficiaries already have a number of protections in place when telehealth services are provided through an ACO entity that reduces the possibility of abuse. We believe the requirements in the proposed rule are robust and already significantly reduce the possibility for abuse. The proposed requirements provide transparency on the contributions of telehealth and related services in meeting the ACO s goals and performance on quality measures. The ACOs structure and design provides fraud and abuse protections similar to those available in Medicare Advantage plans and we do not believe there is a need for additional transparency requirements singling out telehealth. We strongly recommend that CMS not impose additional requirements for telehealth only. We note that we would retain the right to monitor and audit the use of such waivers. We would anticipate implementing heightened monitoring of entities that bill under payment waivers to reduce the possibility of abuse of the waiver. We seek comments on what specific activities should be monitored to ensure that items and services are properly delivered to eligible patients. ATA recognizes allowing ACOs to use the Medicare waivers is an important step forward and understands CMS s concerns about making sure the waivers are used properly. We are very supportive of allowing the waivers and having reasonable provisions to assure they are used properly, demonstrate value in meeting the clinical needs of beneficiaries and do not create opportunities for fraud and abuse. As noted above, we are concerned, however, about requirements singling out telehealth and related services and treating them differently than other components of care coordination and ACO plan management and governance. To the extent that telehealth services are part of those programs, they can be monitored and audited accordingly. For example, the ACO quality assurance and improvement program will include a written plan that describes how the how the Page 9 of 12

10 clinical needs of beneficiaries will be met. The shared saving program description and annual assessment of the quality of care can include the scope of telehealth and related technologies in the same way that it includes care coordination, network contracting or other activities. The ACO governing body is accountable for all the provisions of the ACO application and using the waiver properly should have the same standing as complying with the terms of the shared savings program, the quality improvement program or public reporting on the website. These program activities are monitored and audited as part of the standard ACO audit and where applicable telehealth and related activities can be monitored and audited as well. As noted above, we are concerned about singling out telehealth and related services for separate or heightened monitoring and audit requirements. Page We seek comment on the telehealth rules that would require a waiver and the circumstances under which a waiver would be necessary. Specifically, what aspects of current Medicare telehealth payment and other rules would it be necessary to waive in order to effectively incorporate two-sided performance-based risk into the Shared Savings Program? A unique issue for telehealth payment is Medicare does not allow fee-splitting. To compensate a patient site for related costs, Medicare uses a flat nationwide originating site facility fee for the patient site. Some recent Congressional bills expanding Medicare telehealth originating sites (such as a beneficiary at home) would not extend the facility fee to these sites. We recommend that Medicare pay for telehealth services under the existing Medicare payment methods for covered services and that an ACO have the flexibility to describe an alternative payment for services beyond the restrictions of 1834(m). For example, most public and private payors do not restrict telehealth coverage to a subset of designated CPT/HCPCS codes. What factors should CMS consider if it were to provide for such a waiver to allow ACOs additional flexibility to provide a broader range of telehealth services or services in a broader range of geographic areas? Since Medicare will be paying ACO professionals, ACO providers/suppliers and hospitals providing a telehealth service based on their location and some ACOs serve Medicare beneficiaries in more than one state, we request that CMS allow health professionals and facilities participating in an ACO to be licensed only at their location, not necessarily also at a patient s location. Also, how should telehealth be defined? While telehealth is not consistently defined across payers, telehealth typically refers to a broader set of services, including Page 10 of 12

11 store and forward services, which are not currently covered by Medicare outside of demonstration projects. An ACO should be able in its application to define telehealth that is broader than the longstanding delineation in section 1834(m) and (a)(1) and (3). If another definition is needed for ACO purposes, we recommend adopting a simpler, technology-neutral definition that is expected to be used by the National Association of Insurance Commissioners: Telemedicine or Telehealth means health care services to a covered person from a health care provider who is at a site other than where the covered person is located using telecommunications technology. Under what circumstances should payment for telehealth and related services be made? Payment for telehealth and related services should be made in accord with an ACO s described services and on the same basis as comparable in-person services. What types of services should be included remote monitoring, remote visits and/or e- consults? An ACO should have the flexibility to include additional services according to their application, beyond that specified in 1834(m). What capabilities or additional criteria should ACOs meet in order to qualify for payments for telehealth services under such a waiver? The ACO should not need to have any additional capabilities or meet any additional criteria to qualify for telehealth services under such a waiver. The agreements with ACO participants and ACO providers/suppliers requires the ACO participant to adhere to the quality assurance and improvement program and evidence based medicine guidelines and it must also permit the ACO to take remedial action against the ACO providers/suppliers including corrective action up to termination if they are determined to be noncompliant with the requirements of the Shared Savings Program. These requirements are sufficient to allow ACO entities and their providers/suppliers to qualify for payment of telehealth services. These requirements also support expanding and updating the telehealth and related services definition and allowing the Medicare waivers in the ACO project. In your comments, please consider quality and outcomes metrics, other requirements to ensure protection of beneficiaries and the Medicare Trust Funds, and any other design factors you think may be important. ACOs are required to complete an annual assessment of the ACO s quality of care and address other relevant matters (see (a)(9)) as well as meet quality reporting requirements set forth in subpart F. of of the Shared Savings Program. At this time, we do not recommend burdening the ACOs with additional metrics. Over time, it may be useful to better measure patient review of quality of care, ease of access, convenience and overall satisfaction. Page 11 of 12

12 Summary The American Telemedicine Association strongly supports expanding the telehealth definitions, allowing the Medicare waivers and applying the same regulatory oversight to telehealth and related services that is required of the other similar components of care coordination and ACO operations in the Final Rule. We appreciate and support the CMS s efforts and commitment to expanding the role of ACOs in the Medicare Shared Savings Program. Thank you for the opportunity to share our comments with you. Please feel free to contact me at (202) or jlinkous@americantelemed.org if you would like to discuss these comments in detail or have any questions. Sincerely, Jonathan D. Linkous Chief Executive Officer Page 12 of 12