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FTC Staff Letter to the Centers for Medicare and Medicaid Services Regarding the Interim Final Rule with Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency
us-ftc-advocacy-filings-02022a0420d3ae4686c4bc43da601066FTC Staff Letter to the Centers for Medicare and Medicaid Services Regarding the Interim Final Rule with Policy and Regulatory Revisions in Response to the COVID-19 Public Health EmergencyAdvocacy Filing
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V200009
UNITED STATES OF AMERICA FEDERAL TRADE COMMISSION WASHINGTON, D.C. 20580 Office of Policy Planning Bureau of Competition Bureau of Economics Office of the General Counsel May 29, 2020 Centers for Medicare & Medicaid Services Department of Health and Human Services P.O. Box 8016 Baltimore, MD 20244-8016 Attention: CMS-1744-IFC, Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency The staffs of the Federal Trade Commission’s (“FTC”) Office of Policy Planning, Bureau of Economics, Bureau of Competition, and Office of the General Counsel1 (collectively, “FTC staff”) appreciate the opportunity to respond to your request for comments on the Interim Final Rule with Comment Period entitled Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency (“IFC”).2 The IFC aims to give flexibility, such as an increased ability to use telehealth, to individuals and entities that provide services to Medicare beneficiaries. The IFC therefore may enable these service providers to respond more effectively to the serious public health threats posed by the pandemic. Public and private reimbursement laws and policies frequently are cited as impeding the development and widespread use of telehealth services. By limiting entry of telehealth practitioners, overly restrictive reimbursement requirements may unnecessarily limit consumers’ access to care and choice of practitioner, especially in areas where there is a shortage of healthcare professionals and at times outside normal business hours. Reducing restrictions on Medicare reimbursement for telehealth services is especially important, not only to enhance the use of telehealth to care for Medicare beneficiaries, but also to encourage private payers to expand the use of telehealth. Reducing or eliminating restrictions on reimbursement of telehealth services could potentially enhance competition, improve access and quality, and decrease health care costs in both the public and private sectors. This comment supports the IFC’s provisions to reduce or eliminate restrictive Medicare payment requirements for telehealth and communication technology-based services (“CTBS”) during the current public health emergency,3 thus mitigating the exposure risk of patients and health care professionals. We also make a number of suggestions to further reduce restrictions that may be unnecessary for safety and quality. Finally, we suggest that CMS use the experience it gains from reimbursing a broader set of telehealth services, providers, and CTBS during the public health emergency to develop additional empirical evidence on the effects of these policies and to consider whether some of the regulatory revisions discussed in this letter should be made permanent.4 Doing so could benefit patients, practitioners, and the health care system as a whole. 1
I. Interest and Experience of the Federal Trade Commission The FTC is charged under the FTC Act with preventing unfair methods of competition and unfair or deceptive acts or practices in or affecting commerce.5 Competition is at the core of America’s economy,6 and vigorous competition among sellers in an open marketplace gives consumers the benefits of lower prices, higher quality products and services, and increased innovation. Because of the importance of health care competition to the economy and consumer welfare, anticompetitive conduct in health care markets has long been a key focus of FTC law enforcement,7 research,8 and advocacy.9 Many of our recent advocacy comments have addressed scope of practice and supervision requirements that may unnecessarily limit the range of procedures or services a practitioner may provide, or unnecessarily restrict a particular type of practitioner from competing in the market.10 Telehealth is an area of particular interest to the FTC because of its potential to increase the supply of available practitioners, encourage competition, and improve access to affordable, quality health care. In a 2004 report, the federal antitrust agencies considered the competitive effects of state restrictions on the interstate practice of telemedicine.11 The central finding of that analysis remains applicable today: “When used properly, telemedicine has considerable promise as a mechanism to broaden access, lower costs, and improve health care quality.”12 More recently, the Commission reiterated these benefits when it closed an investigation of the Texas Medical Board after the Texas legislature enacted a law overriding the Board’s rules restricting the practice of telehealth.13 FTC staff also submitted comments to the Alaska legislature and the Department of Veterans Affairs (“VA”) supporting proposals to allow licensed physicians to provide telehealth services across state lines.14 FTC staff continued to support license portability for telehealth in the 2018 report, Options to Enhance Occupational License Portability.15 FTC staff also commented on telehealth issues in regard to a Washington state bill and regulations proposed by three Delaware occupational licensing boards.16 These letters recommend that health care practitioners be allowed to use their own judgment in deciding whether the use of telehealth services is appropriate under the circumstances. The conclusions of the agencies’ 2004 report and these recent FTC staff comments support reducing unjustified barriers to telehealth and underpin this comment. II. The Interim Final Rule: Regulatory Changes to the Current Framework for Telehealth in Response to the COVID-19 Public Health Emergency Telehealth, if broadly deployed, has the potential to mitigate challenges in access to health care arising from an aging population, healthcare workforce shortages, and geographic and other mal-distributions of providers. Telehealth can also address the needs of urban underserved patients who experience provider shortages arising from economic disparities and limited mobility, to the extent that these patients can access the necessary technology.17 Telehealth can potentially increase the supply of accessible practitioners and thereby enhance price and non-price competition, reduce transportation expenditures, and improve access to and choice of quality care.18 Many experts consider reducing restrictions on Medicare reimbursement of telehealth services especially important for fulfilling telehealth’s potential, not only because Medicare places substantial limitations on using telehealth services, but also because Medicare influences the reimbursement policies of state Medicaid programs and private 19 payers. 2
FTC staff support CMS as it reduces restrictions on Medicare reimbursement of telehealth services during this public health emergency, thus mitigating the exposure risk of patients and health care professionals. This comment provides a competition perspective on Medicare payment of telehealth services both during and after the public health emergency. In particular, we consider the IFC’s provisions with regard to six categories: 1) eliminating originating site and geographic requirements, thus allowing telehealth services to be provided to patients at any location, including the home; 2) expanding the types of services that may be furnished by telehealth; 3) providing for access to therapy services furnished by providers who are not statutorily authorized telehealth providers; 4) expanding the use of telehealth telecommunication modalities, including audio-only telephone; 5) allowing CTBS for new as well as established patients; and 6) allowing direct supervision required under Medicare’s “incident to” billing rules to be carried out via interactive telecommunications technology. A. Allowing Telehealth Services to be Provided to Patients at Any Location, Including the Home We support CMS’s use of its waiver authority to allow Medicare to reimburse telehealth services provided to a patient at any location, including the patient’s residence, during this public health emergency.20 This temporarily eliminates a major and longstanding barrier to providers of telehealth services.21 Ordinarily, Medicare’s fee-for-service program pays providers for telehealth services only when patients are located at certain types of health care facilities (“originating sites”),22 and the facilities must be located in rural areas with a shortage of health professionals.23 Therefore, Medicare does not reimburse for telehealth services furnished to a patient at a residence, or in a metropolitan area. By restricting reimbursement, Medicare reduces the supply of providers, access to telehealth services, and competition at such locations. Allowing reimbursement of telehealth services in the home, in any geographic area, will greatly increase the ability to provide care safely during the pandemic. To mitigate exposure risk from COVID-19, the greatest need for telehealth services may be in densely populated urban areas where COVID-19 cases are common.24 As a result of shelter-in-place orders, both uninfected and infected patients are often at their homes or other residences.25 By allowing telehealth services to be provided to patients anywhere, including at their residences, the waiver allows more patients to receive services without jeopardizing their health or the health of the professionals who provide care.26 Although the public health emergency necessitated immediate removal of the geographic and originating site requirements, longstanding and broad support for eliminating these requirements existed before the pandemic.27 These requirements preclude reimbursement for services provided to urban beneficiaries with limited access to in-person care because of mobility, economic, or other barriers, as well as rural populations who may live far from an authorized originating site. The requirements inhibit entry of telehealth providers and limit patients’ access to care and choice of provider. Accordingly, the requirements could limit competition among practitioners, potentially reducing the quality and amount of care and increasing its costs. For these reasons, we strongly support suspending these requirements during the public health emergency, and we urge CMS to consider whether they should be permanently eliminated. Doing so would be consistent with the administration’s 2018 report, Reforming America’s Healthcare System Through Choice and Competition, which recommends that 3
“Congress should consider proposals modifying geographic location and originating site requirements in Medicare fee-for-service that restrict the availability of telehealth services to Medicare beneficiaries in their homes and in most geographic areas.”28 Experience during the pandemic with reimbursing telehealth services not subject to originating site and geographic location requirements should be helpful in evaluating whether it would also be beneficial to eliminate these requirements permanently after the emergency ends. B. Expanding the Types of Services that May be Furnished by Telehealth We also support the expansion of the types of Medicare-reimbursable telehealth services set forth in the IFC. By improving access to telehealth services and providers, patients, practitioners, and the Medicare program should benefit. Ordinarily, Medicare’s fee-for-service program restricts the services that can be provided via telehealth. The statute limits reimbursable telehealth services to “professional consultations, office visits, and office psychiatry services,”29 which has resulted in a relatively short and narrow list of reimbursable telehealth services.30 The Secretary of the U.S. Department of Health and Human Services (“HHS”), however, may authorize additional services as warranted.31 To mitigate the risks of COVID-19 exposure for both patients and health care professionals, CMS has authorized more than 80 additional types of telehealth services during this public health emergency, including emergency department visits, initial nursing facility and discharge visits, intensive care unit services, and home visits.32 CMS does not consider the newly authorized services to be similar to the original, statutorily authorized services. Indeed, under normal procedures, CMS probably would not approve these procedures for reimbursement without a clinical study demonstrating patient benefit.33 But, in the face of this public health emergency where exposure risks are significant, CMS authorized the use of telehealth for these services.34 This vast expansion of the types of reimbursable services eliminates a major restriction on telehealth care and allows telehealth services to be provided in novel and innovative ways that could improve triage, diagnosis, and treatment of COVID-19 patients. It also will reduce the coronavirus exposure risks of non-COVID-19 patients and health care professionals.35 Without this expansion of reimbursable telehealth services, it could be difficult or impossible to provide many of the newly authorized services safely. By allowing practitioners to provide services remotely, especially in areas of need that are far away, the change likely increases beneficiaries’ access to needed care during the public health crisis. The change also could enhance the quality of services provided, increase competition, and reduce costs. The expansion of reimbursable telehealth services during this public health emergency should highlight the benefits and drawbacks of using telehealth to provide different types of services. As a result, CMS will be in a better position to decide whether to continue some or all of the added services after this emergency ends.36 C. Access to Therapy Services Furnished by Providers Who Are Not Statutorily Authorized Telehealth Providers Another major barrier to telehealth uptake is Medicare’s restrictions on the types of practitioners who are authorized to be reimbursed for telehealth services. Because of this statutory limitation, the IFC does not authorize payment to therapy practitioners, such as physical therapists, occupational therapists, and speech-language pathologists.37 Nevertheless, we support 4
CMS’s use of its waiver authority after the IFC was issued to designate these and other practitioners as authorized Medicare telehealth services providers. We believe this will enhance the supply of and access to therapy services. Therapy practitioners are able to provide many services to patients through telehealth. For example, speech-language pathologists can screen and treat students using telepractice, and audiologists can carry out diagnostic hearing assessments and hearing aid programming remotely.38 Physical therapists, occupational therapists, speech-language pathologists, audiologists, and others provide telerehabilitation care, which helps patients with stroke, head and spinal injury, neurological disorders, and other diseases regain everyday skills and maintain quality of life. In fact, telerehabilitation has the advantage of allowing the therapist to tailor care to the patient’s home or residence.39 Although the IFC sets forth two approaches to improving remote access to therapy services, neither approach authorizes therapy practitioners to be reimbursed for telehealth services. Specifically: First, the IFC authorizes payment for certain telehealth therapy services, such as physical therapy, occupational therapy, and speech-language pathology therapy, but only when the services are provided by the statutorily authorized telehealth providers, such as physicians, nurse practitioners, or physician assistants.40 Limiting reimbursement for telehealth therapy services to practitioners who do not ordinarily deliver these types of services, and lack the necessary expertise, is unlikely to facilitate remote access to safe and effective therapy services.41 Second, CMS authorizes therapy professionals to provide some remotely delivered CTBS, which are services that are routinely furnished using a telecommunications system but are not considered telehealth services. Examples include remote evaluation of online videos and virtual check-in services.42 But such services, referred to as “sometimes therapy” by CMS, do not facilitate continuing care by non-authorized providers.43 CMS subsequently used the broad waiver authority granted under Section 3703 of the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”),44 which was enacted after the IFC was written, to allow therapy professionals, including physical therapists, occupational therapists, speech-language pathologists, audiologists, and all professionals eligible to bill Medicare, to be authorized Medicare telehealth providers during this public health emergency.45 Doing so allows a variety of therapy services to be delivered with little risk of exposure to COVID-19, benefiting both patients and practitioners. Based on its experience with reimbursing therapy practitioners for telehealth services during the current public health crisis, CMS should consider permanently adding these practitioners to the list of authorized telehealth providers. There is longstanding support for Medicare reimbursement of therapy practitioners and other practitioners not ordinarily eligible for reimbursement of telehealth services.46 Making them authorized telehealth providers on a permanent basis could enhance the availability of therapists, access to care, choice of provider, competition, and quality, and also could reduce costs. Such improvements may especially benefit rural and underserved communities, as well as patients for whom travel is difficult.47 5
D. Telehealth Telecommunication Modalities, Including Audio-Only Telephone We support CMS’s use of its waiver authority under the CARES Act to expand the list of reimbursable telehealth services that may be provided by audio-only telephone.48 Although not prohibited by statute, services provided by audio-only telephone are not ordinarily reimbursable telehealth services under Medicare. Allowing Medicare to pay for certain audio-only telephone care as telehealth services could increase access, choice, and competition in the supply of telehealth services. Under existing Medicare regulations, telehealth services must be provided by a live, interactive telecommunications system with both audio and video components.49 The IFC did not change the regulatory restriction.50 Although the use of smartphones and other devices with audio/video capability is widespread, not all patients have smartphones, or a suitable computer or device with webcam and broadband access. Indeed, Medicare beneficiaries, the vast majority of whom are over 65 years of age, are in the demographic least likely to have or use audio/video systems. Rural and lower-income Americans may also lack suitable equipment.51 Even medical practices ramping up their telehealth capabilities have encountered difficulties such as dropped calls, poor quality, and lags when providing video visits, and have found that audio-only telephone calls form the basis of much of their care.52 CMS acknowledges in the IFC that during the pandemic, audio-only telephone communication may be the only clinically appropriate option because two-way audio/video technology might be unavailable.53 Accordingly, the IFC authorizes limited reimbursement of audio-only telephone care as a non-telehealth service routinely provided by a telecommunications system.54 But, as discussed above, restrictions on reimbursement of such CTBS may limit its utility for continuing care.55 Allowing reimbursement for care provided by audio-only telephone as a telehealth service potentially increases access to safe and effective care and enhances competition among providers, especially in rural and underserved areas where access to audio/video devices and broadband service may be limited.56 We suggest that CMS consider whether such benefits support continuing telehealth reimbursement of audio-only telephone services after this crisis, or whether its experience with expanded telehealth reimbursement of these services reveals legitimate health and safety concerns that could justify discontinuing or narrowing such reimbursement after this public health emergency ends. E. Medicare’s Established Patient Requirement for Non-Telehealth Communication Technology-Based Services (“CTBS”) Ordinarily, Medicare reimbursement of CTBS is available only when a practitioner cares for an established patient. There must be an established patient-practitioner relationship before a practitioner furnishes CTBS services such as virtual check-ins, remote physiologic monitoring, or telephone evaluation/management services.57 Medicare generally defines an established patient as one that a practitioner, or another practitioner in the same practice, has seen in person during the past three years.58 Because rigid established patient and in-person examination requirements restrict the supply of available practitioners and may be unnecessary to protect consumers, we support CMS’s decision to enhance access to certain CTBS services during this public health emergency, either by modifying CMS’s requirements to allow these services to be provided to new as well as established patients, or by exercising its enforcement discretion.59 As the IFC explains, brief communications and other services categorized as CTBS might reduce the 6
need for a risky in-person visit and “should be available to as large a population of Medicare beneficiaries as possible.”60 More generally, by excluding reimbursement for services provided to new patients who have not seen a practitioner in person, the “established patient” requirement restricts care from direct-to-consumer (“DTC”) telehealth companies. Patients initiate contact with DTC companies, which typically provide care around-the-clock, using practitioners located anywhere, often beyond the range of a patient’s established in-person provider.61 By excluding such distant practitioners from providing CTBS, the “established patient” requirement restricts the supply of providers of telecommunication-based services, and may be unnecessary to protect consumers. Similarly, the “established patient” requirement prevents practitioners in traditional office settings—whether in the patient’s geographic area, or distant from it—from providing CTBS to new patients. As discussed in a number of FTC staff advocacy comments, in-person examination requirements prevent licensed health care providers from providing telehealth care that they otherwise would deem appropriate. Such restrictions potentially reduce competition, innovation, consumer choice, and the supply and quality of care, and may also increase price. Accordingly, FTC staff advocacy comments have opposed proposed laws and regulations that prohibit the use of telehealth for initial, as well as subsequent evaluations. Rather, FTC advocacy has favored flexible provisions that allow the licensed practitioner in the best position to weigh access, health, and safety considerations to decide whether to use telehealth. Such policies, which allow the patient-practitioner relationship to be established by telehealth and typically hold the practitioner to an in person standard of care, are supported by several physicians’ organizations.62 We suggest that after the public health emergency ends, CMS consider allowing licensed practitioners to decide whether to provide at least some CTBS services to new as well as established patients. This approach would better promote competition and access to safe and affordable care. F. Allowing Direct Supervision Required Under Medicare’s “Incident To” Billing Rules to be Carried Out Via Telecommunications Technology In many circumstances, Medicare requires certain types of practitioners to be supervised at particular levels as a condition for payment for their services. Under Medicare’s “incident to” billing provisions, physicians can bill Medicare for services provided by nonphysician practitioners under their direct supervision,63 such as advanced practice registered nurse practitioners (“APRNs”) and physician assistants (“PAs”). Direct supervision, typically considered the most restrictive level of supervision, means that a physician or other supervisor must be present in the office suite and immediately available to provide assistance and direction.64 The IFC temporarily relaxes the direct supervision requirement during the public health emergency by changing the definition of direct supervision to allow remote supervision using audio/video telecommunications technology, thereby reducing COVID-19 exposure risk.65 Although the change reduces exposure risk, it does not fully alleviate other potential negative effects of direct supervision requirements—for example, on practitioner efficiency, access to care, and practitioner supply. We suggest that CMS eliminate the direct supervision requirement for nonphysician practitioners such as APRNs and PAs, deferring instead to any 7
state supervision requirements. In the many states that allow APRNs and PAs to practice with less stringent supervision, this change would directly benefit healthcare consumers. Unduly restrictive supervision requirements directly impact access to nonphysician practitioners by limiting their supply where supervisors are scarce—for example, in areas where there is a shortage of health care professionals and in rural and underserved settings where supervising physicians are often unavailable.66 Direct supervision, which requires a supervisor to be on site, is particularly restrictive, barring affiliated practitioners from practicing in places where a supervisor is not physically present.67 Because practitioners could not care for homebound patients in underserved areas that lack supervising physicians, Medicare started to allow general supervision, which does not require a supervisor to be on site, for “incident to” services provided to homebound patients.68 To further address such issues, in 1997, Congress granted nonphysician practitioners the ability to bill Medicare directly in all practice settings, under reduced supervision levels such as general supervision or collaboration.69 But many noninstitutional settings, like offices, still use “incident to” billing requiring direct supervision due to the incentives created by Medicare’s reimbursement rate structure.70 In these settings, physicians may use “incident to” billing under Medicare for services provided by PAs, nurse practitioners (“NPs”), and clinical nurse specialists (“CNSs”) under their direct supervision at 100 percent of the physician fee schedule rate, rather than the 85 percent rate used if these practitioners were to bill Medicare directly.71 Because of this payment differential, employers of these nonphysician practitioners have a financial incentive to use “incident to” billing, thus triggering the direct supervision requirement.72 Allowing physicians to directly supervise nonphysician practitioners remotely using telecommunications is unlikely to eliminate the restrictive impacts of direct supervision on access to care, practitioner efficiency, and competition, especially during the public health emergency. During the pandemic, the capacity of supervising physicians and nonphysician practitioners to provide care may be stretched thin. “Incident to” billing requires “the physician’s continuing active participation in and management of the course of treatment,”73 even when this level of supervision may not be necessary to ensure patient health and safety, potentially resulting in inefficient duplication of efforts by supervisors and supervisees.74 According to the Medicare Payment Advisory Commission (“MedPac”), “these billing rules could keep physicians from optimally structuring their practice for efficiency and access,” for example “by requiring APRNs and PAs to treat established patients when their time might be better spent dealing with new patients with certain injuries or illnesses.”75 Even if supervision is provided by audio/video telecommunication,76 it is still unnecessary and counterproductive to require physicians to take time from patient care to directly supervise PAs, APRNs, and other nonphysician practitioners who have extensive education and training and who, under state law, are often allowed to work independently or with lower levels of supervision. HHS recognized this potential for supervision requirements to impair the efficiency of the COVID-19 response when it recommended that states “[t]emporarily suspend . . . any requirements for written agreements to meet supervision or collaboration requirements, in order to avoid significant delays in the provision of services.” Acknowledging the effects of requirements for an on-site supervisor, HHS also recommended that states “temporarily waive any requirements that the supervising physician be physically co-located with or within a certain geographic distance to the NP or PA who he or she is supervising.”77 In its Guidance to States, HHS summed up its position by recommending that states “allow health care professionals like 8
nurse practitioners (NPs), other registered nurses, and physician assistants (PAs) to practice to the fullest extent of their license and without restrictive supervision requirements.”78 Similarly, in changing the required level of supervision for hospital outpatient therapeutic services from direct to general in 2020, CMS explained that direct supervision “places an additional burden on providers that reduces their flexibility to provide medical care,” especially in rural hospitals where there may be insufficient staff to furnish direct supervision. Moreover, in CMS’s experience, “Medicare providers will provide a similar quality of hospital outpatient therapeutic services, regardless of whether the minimum level of supervision required under the Medicare program is direct or general.”79 Notably, Medicare’s direct supervision requirement for “incident to” billing operates in addition to any state supervision or collaboration requirements. Most state requirements were much less restrictive than Medicare’s requirement even before states reduced required supervision in response to the public health emergency. Before the COVID-19 crisis, about half the states allowed nurse practitioners to practice independently, and a smaller number required supervision or collaboration agreements.80 For PAs, while states generally required a specific supervisory or collaborative relationship with a physician, few required on-site supervision.81 We recommend that CMS amend its Medicare rules to eliminate direct supervision of nonphysician practitioners in noninstitutional settings, and rely instead on each state’s supervision or collaboration requirements to determine the level of oversight. For purposes of Medicare, the rules should allow any state-required supervision or collaboration to be provided by telecommunication systems as authorized by state law.82 Eliminating Medicare’s direct supervision requirement could improve access to health care professionals and services, especially in health professional shortage and underserved areas. Accordingly, we urge CMS to consider whether there are well-founded health and safety justifications for retaining the direct supervision requirement. More generally, we recommend that CMS ask Congress to eliminate the “incident to” billing provision, which is a vestige of a time when advanced practice registered nursing and physician assisting were nascent professions, and when state laws governing supervision of such practitioners were more restrictive.83 Instead, nonphysician practitioners should be required to bill Medicare directly, consistent with the recommendations of the report, Reforming America’s Healthcare System Through Choice and Competition,84 and the 2019 MedPac Report to Congress.85 Doing so could improve provider efficiency and beneficiary access to care and potentially reduce Medicare spending and beneficiary financial liability.86 III. Conclusion By connecting widely separated providers and patients, telehealth can alleviate primary care and specialty shortages, especially in rural areas. Telehealth can also address the needs of urban patients who have difficulty accessing providers due to economic disparities and limited mobility. Reducing or eliminating certain reimbursement requirements could enhance the availability of telehealth providers; increase competition on price, quality, and innovation; and help improve outcomes and control costs. Reducing restrictions on reimbursement of telehealth and other telecommunications- based services is essential during the public health emergency to allow health care professionals 9
to provide care safely to Medicare beneficiaries, and to support and enhance the vast expansion of telehealth care that is already underway. We commend CMS and support the IFC’s provisions to reduce or eliminate restrictive Medicare telehealth payment provisions. At the same time, we respectfully suggest that CMS consider, in light of existing empirical evidence and any new evidence generated by these temporary measures, whether our suggestions to further reduce such restrictions, both during and after the public health emergency, would help to provide care safely, and also better promote competition and access to safe and affordable care. We appreciate your consideration. Respectfully submitted, Bilal Sayyed, Director Office of Policy Planning Andrew Sweeting, Director Bureau of Economics Ian Conner, Director Bureau of Competition Alden F. Abbott, General Counsel Office of the General Counsel 1 This letter expresses the views of staff in the Federal Trade Commission’s Office of Policy Planning, Bureau of Economics, Bureau of Competition, and Office of the General Counsel. The letter does not necessarily represent the views of the Federal Trade Commission or of any individual Commissioner. The Commission, however, has authorized us to submit these comments. 2 Interim Final Rule with Comment Period, Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency, 85 Fed. Reg. 19,230 (April 6, 2020) (to be codified at 42 C.F.R. pts. 400, 405, 409-10, 412, 414-15, 417-18, 421-23, 425, 482, 510). The regulations became effective on March 31, 2020, and applicable on March 1, 2020. See id. at 19,230. 3 Pursuant to the Public Health Service Act § 319 (42 U.S.C. § 247d), Alex M. Azar II, Secretary of Health and Human Services, determined on Jan. 31, 2020, that a nationwide public health emergency (“PHE”) existed since 10
Jan. 27, 2020 due to the 2019 Novel Coronavirus. The Secretary renewed the PHE on April 21, 2020. See Renewal of Determination That a Public Health Emergency Exists, https://www.phe.gov/emergency/news/healthactions/phe/Pages/covid19-21apr2020.aspx. A PHE lasts until the Secretary determines it is over, or a maximum of 90 days, but can be renewed as necessary. 42 U.S.C. § 247d(a). When a PHE has been declared, under section 1135 of the Social Security Act the Secretary can waive or modify certain Medicare and Medicaid requirements to ensure the availability of goods and services for those programs and to allow reimbursement of providers who cannot comply with certain requirements. A Presidential declaration of an emergency or disaster under the National Emergencies Act, 50 U.S.C. § 1601 et seq., is also necessary to exercise this authority. See 42 U.S.C. § 1320b-5. On Mar. 13, 2020, President Trump declared a National Emergency effective March 1, 2020. See Proclamation No. 9994, 85 Fed. Reg. 15,337 (Mar. 18, 2020). 4 We take no position on the IFC’s regulatory revisions not discussed in this letter. 5 Federal Trade Commission Act, 15 U.S.C. § 45. 6 Standard Oil Co. v. FTC, 340 U.S. 231, 248 (1951) (“The heart of our national economic policy long has been faith in the value of competition.”). 7 See generally MARKUS H. MEIER ET AL., FTC, OVERVIEW OF FTC ACTIONS IN HEALTH CARE SERVICES AND PRODUCTS, https://www.ftc.gov/tips-advice/competition-guidance/industry-guidance/health-care (most recent version under “Core Health Care Competition Documents”). 8 See, e.g., FTC & U.S. DEP’T OF JUSTICE, IMPROVING HEALTH CARE: A DOSE OF COMPETITION (2004), http://www.ftc.gov/reports/healthcare/040723healthcarerpt.pdf. 9 FTC and staff advocacy can include letters or comments addressing specific policy issues, Commission or staff testimony before legislative or regulatory bodies, amicus briefs, and reports. See, e.g., Comment from FTC Staff to Thomas E. Brinkman, Jr., Representative, Ohio House of Representatives (Jan. 9, 2020), https://www.ftc.gov/system/files/documents/advocacy_documents/ftc-staff-comment-ohio-house-representatives- concerning-ohio-house-bill-177/v200005ohiohb177aprnscomment.pdf (discussing the likely procompetitive effects of a Bill that would expand the scope of practice of APRNs in Ohio by ending Ohio’s mandatory written collaborative agreement requirement); Brief of Amicus Curiae FTC in Support of No Party, In re Nexium (Esomeprazole) Antitrust Litig., No. 15-2005 (1st. Cir. Feb. 12, 2016), https://www.ftc.gov/system/files/documents/amicus_briefs/re-nexium-esomeprazole-antitrust- litigation/160212nexiumbrief.pdf (explaining that a reverse payment from a brand-name drugmaker that is used to settle patent litigation can violate the antitrust laws if it induces a generic drugmaker to abandon its patent challenge and stay out of the market); FTC STAFF, POLICY PERSPECTIVES: COMPETITION AND THE REGULATION OF ADVANCED PRACTICE NURSES (“APRNS”) (2014), https://www.ftc.gov/system/files/documents/reports/policy-perspectives- competition-regulation-advanced-practice-nurses/140307aprnpolicypaper.pdf [hereinafter FTC STAFF POLICY PERSPECTIVES] (presenting an overview of FTC staff comments regarding APRNs, and an in depth analysis of the competitive effects of statutes and rules governing APRN scope of practice and supervision). 10 See, e.g., Comment from FTC Staff to Daniel R. Hawkins, Rep., Kansas House of Representatives (Jan. 9, 2020), https://www.ftc.gov/system/files/documents/advocacy_documents/ftc-staff-comment-kansas-house-representatives- concerning-kansas-house-bill-2412/v200006kansashb2412aprnscomment.pdf (commenting on a bill that would eliminate a written collaboration agreement requirement for APRNs, and shift regulatory authority over APRNs from the nursing board to the medical board); Comment from FTC Staff to the Dep’t of Veterans Affairs (July 25, 2016), https://www.ftc.gov/system/files/documents/advocacy_documents/comment-staff-ftc-office-policy-planning- bureau-competition-bureau-economics-department- veterans/v160013_staff_comment_department_of_veterans_affairs.pdf (supporting proposed rule that would allow APRNs to provide VA services without physician oversight ). 11 See FTC & U.S. DEP’T OF JUSTICE, supra note 8, ch. 2, at 30 (section on “State Restrictions on the Interstate Practice of Telemedicine”). 12 Id. at Executive Summary at 23. 11
