{"id":47857,"date":"2020-06-22T18:22:04","date_gmt":"2020-06-22T17:22:04","guid":{"rendered":"https:\/\/blogs.bmj.com\/bmj\/?p=47857"},"modified":"2020-06-29T17:26:34","modified_gmt":"2020-06-29T16:26:34","slug":"a-regulatory-response-to-covid-19-unleash-telehealth","status":"publish","type":"post","link":"https:\/\/blogs.bmj.com\/bmj\/2020\/06\/22\/a-regulatory-response-to-covid-19-unleash-telehealth\/","title":{"rendered":"A regulatory response to covid-19: unleash telehealth"},"content":{"rendered":"

In response to the covid-19 pandemic, US Health and Human Services (HHS) Secretary, Alex Azar declared a public health emergency on 31 January 2020. On 13 March 2020, US President Donald Trump issued an emergency determination under section 501(b) of the Robert T. Stafford Disaster Relief and Emergency Assistance Act reiterating that the country was facing a significant public health emergency.
\n<\/span><\/p>\n

These events triggered an emergency grant of authority that allowed Azar to waive programme requirements in Medicare under Section 1135 of the Social Security Act. Later in March 2020, two subsequent laws in response to the covid-19 pandemic were enacted, H.R. 6201 the Families First Coronavirus Response Act (enacted 18 March 2020), and H.R. 748 the Coronavirus Aid, Relief, and Economic Security (CARES) Act (enacted 27 March 2020). Both laws further clarified and emboldened Secretarial waiver authority over Medicare program services.<\/span><\/p>\n

Between the frenetic pace of guidance development, aggressive exercise of enforcement discretion, and the eventual release of two CMS Interim final rules on policy and regulatory revisions in response to the covid-19 public health emergency, the Centers for Medicare & Medicaid Services (CMS) initially delivered sixty-six blanket waivers within the course of weeks, and continued to announce additional flexibilities through the end of April. [1]<\/span> The waiving of Medicare program requirements opened the possibility of remarkable reform in healthcare delivery.\u00a0\u00a0<\/span><\/p>\n

To support the pandemic response, CMS moved quickly to broaden Medicare telehealth services, allowing beneficiaries to access services from their doctors without visiting a healthcare facility. Suddenly, a decade\u2019s worth of arduous telehealth service restrictions dissolved, followed by the rapid and unparalleled adoption of telehealth services across medical specialties. We discuss the radical adoption of telehealth that occurred through waivers and the importance of critically evaluating whether these advances should be reverted when the emergency ends.<\/span><\/p>\n

The long road for telehealth before covid-19<\/span><\/i><\/p>\n

Telehealth, as required by federal statute and regulation, is live voice and video, delivered to a patient in a healthcare shortage area, from a specific originating site, with a distant site practitioner, providing a limited list of services. [<\/span>2]<\/span> Before the covid-19 public health emergency, the efficacy, efficiency, cost, and available evidence surrounding telehealth was regarded with skepticism by MedPAC and Congress (most notably through the Congressional Budget Office). [<\/span>3]<\/span> The strict regulatory requirements created a barrier to the virtualization of medicine, as evidenced by the low utilization of telehealth services. In 2016, a year in which CMS allocated only $26.9 million dollars out of its nearly $600 billion dollar budget to telehealth services, only 0.25% out of 35 million Medicare Fee-for-Service beneficiaries used the services. [<\/span>4] <\/span>A November 2018 CMS report on telehealth cited rural requirements and the exclusion of a beneficiary\u2019s home as an eligible originating site as the two most significant barriers preventing the expansion of telehealth services. [<\/span>4]<\/span><\/p>\n

Rapid dissemination of telehealth under unanticipated need<\/span><\/i><\/p>\n

The recent waiving of Medicare program requirements accelerated the use of digital medical technologies including telehealth, telemedicine, and remote services for purposes of medical continuity as well as to manage patients who do not require in-patient emergency services. Medicare entered the uncharted territory of encouraging doctors and patients to avoid traditional healthcare originating sites. CMS formally announced that elective surgeries and non-essential medical, surgical, and dental procedures be delayed to encourage patients to remain home to preserve hospital resources, as well as to limit the the exposure of other patients and healthcare workers to the virus. [<\/span>5]<\/span> This sudden shift tested the response mechanisms and burden threshold of the healthcare system in the United States. In an instant, the typical cycle of technological adoption, which includes tested business models, complex business arrangements, clinical validity, evidence, organizational acceptance, infrastructure, interoperability, workforce training, technical staffing, workflows, security protections, legal frameworks, technological specialization, risk mitigation, and dedicated capital, became an afterthought.<\/span><\/p>\n

For the duration of the public health emergency, telehealth visits are considered by CMS as equivalent to in-person visits and are paid at the same rate. Medicare is making payments for professional services in all areas of the country and in all settings and the Department of Health and Human Services is not conducting audits to ensure that a prior relationship existed for submitted claims. Separately, the Office of Inspector General is providing flexibility for healthcare providers to reduce or waive cost-sharing for telehealth visits paid by federal healthcare programs. The Office for Civil Rights\u00a0 is exercising enforcement discretion to waive penalties for HIPAA violations against health care providers who, while serving patients in good faith, utilize communications technologies such as FaceTime or Skype. CMS is also issuing blanket waivers of sanctions under the physician self-referral law that provide flexibility for physicians and providers during the emergency.<\/span><\/p>\n

CMS is also promoting the use of other digital medical modalities such as virtual check-ins, remote evaluations, and eVisits. Remote physiologic monitoring services in particular have been covered and paid since 2018 when CMS distinguished these services from Medicare telehealth and thus not subject to the challenging requirements of section 1834(m).\u00a0<\/span><\/p>\n

What\u2019s next?<\/span><\/i><\/p>\n

Many emergency 1135 waivers are now in place to alleviate requirements that would otherwise inhibit payment to providers using telehealth, but they are temporary. The waivers began upon the President\u2019s invocation of the Stafford Act in addition to the Secretary\u2019s declaration of a public health emergency, both of which were dated retroactive to 1 March 2020. The public health emergency will end no later than the termination of the emergency period, or 60 days from the date the waiver is published. On 15 June 2020, a bipartisan group of senators wrote a letter to the Senate leaders urging for the expanded coverage of telehealth services to be maintained by the CMS and many other legislative efforts are following the suite to make the waivers permanent. [<\/span>6]<\/span>\u00a0<\/span><\/p>\n

The covid-19 public health emergency has provided an unprecedented opportunity to evaluate telehealth services and to determine the expanded role they could play in the future of medicine. This moment should represent more than a temporary easing of restrictions during an unprecedented crisis. To ensure that gains made in the use of telehealth are not lost, it will be critical to appropriately modify healthcare policies so that the best aspects of telehealth adoption could be retained. We will need proper incentives to continue telehealth services, but we also need strategies to evaluate quality, resist abuses, and ensure that the needs of patients are best served. For too long, the full promise of telehealth services has been unrealized. Now is the time to study the benefits and risks of this massive change in healthcare delivery and create ways to integrate these services when they are no longer mandated by a pandemic.<\/span><\/p>\n

Robert Jarrin<\/strong>, <\/span>Department of Emergency Medicine, George Washington University and <\/span>Department of Biochemistry and Molecular & Cellular Biology, Georgetown University Medical Center<\/span><\/em><\/p>\n

Makoto Mori<\/strong>, <\/span>Section of Cardiac Surgery, Department of Surgery, Yale School of Medicine, New Haven, Connecticut and <\/span>Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut<\/span><\/em><\/p>\n

Harlan M. Krumholz<\/strong>, <\/span>Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut and <\/span>Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine and the Department of Health Policy and Management, Yale School of Public Health, New Haven, Connecticut<\/span><\/em><\/p>\n

Conflict of Interest Disclosure:<\/b> MM and HK: None declared. RJ serves as\/on: Advisor to the American Medical Association (AMA) Digital Medical Payment Advisory Group (DMPAG); Steering Committee Member, the Connected Health Initiative (CHI); Advisor, United Spinal Association (USA) Corporate Advisory Council; Co-Chair, Personal Connected Health Alliance (PCHA) U.S. Policy Working Group; paid strategic advisor, ResMed, Inc.; paid strategic advisor, the Consumer Technology Association (CTA); paid strategic advisor and granted equity, Validic, Inc.; paid strategic advisor, BioFourmis, Inc.; paid strategic advisor, Optum Services, Inc. (Vivify Health); paid strategic advisor, Intel Corporation; paid strategic advisor, SomaLogic, Inc.; paid strategic advisor, AliveCor, Inc.; paid strategic advisor, VeruStat Inc.; paid strategic advisor, Advanced ICU Care; paid strategic advisor, Omron Healthcare, Inc.; paid strategic advisor, Life365, Inc.; paid strategic advisor, Qualcomm Incorporated; Advisory Board, Strive Orthopedics (equity compensation); paid strategic advisor and Advisory Board (equity compensation) Pillsy\/Optimize Health; strategic advisor (equity compensation), Reemo Health.<\/p>\n

References:<\/b><\/p>\n

    \n
  1. CMS Medicare Learning Network COVID-19 Update Call. <\/span>https:\/\/www.cms.gov\/outreach-and-educationoutreachnpcnational-provider-calls-and-events\/2020-04-07<\/span><\/a>.\u00a0April 7, 2020. Accessed April 12, 2020.<\/span><\/li>\n
  2. Telehealth services under section 1834(m)(4) of the Social Security Act (42 U.S.C. 1395m(m)(4)).\u00a0\u00a0 Federal Register (66) (F. Telehealth Services).\u00a0 \u00a0 <\/span>https:\/\/www.govinfo.gov\/content\/pkg\/FR-2001-11-01\/pdf\/01-27275.pdf#page=87<\/span><\/a>.\u00a0 November 1, 2001. Accessed April 12, 2020.<\/span><\/li>\n
  3. Housman L, Williams Z, Ellis P. Telemedicine. Congressional Budget Office.\u00a0<\/span>https:\/\/www.cbo.gov\/publication\/50680<\/span><\/a>. July 29, 2015. Accessed April 12, 2020.<\/span><\/li>\n
  4. Mandated report: Telehealth services and the Medicare program. Report to the Congress: Medicare Payment Policy.\u00a0<\/span>http:\/\/www.medpac.gov\/docs\/default-source\/reports\/mar18_medpac_ch16_sec.pdf?sfvrsn=0<\/span><\/a> . March, 2018. Accessed April 13, 2020.<\/span><\/li>\n
  5. CMS Releases Recommendations on Adult Elective Surgeries, Non-Essential Medical, Surgical, and Dental Procedures During COVID-19 Response.\u00a0<\/span>https:\/\/www.cms.gov\/newsroom\/press-releases\/cms-releases-recommendations-adult-elective-surgeries-non-essential-medical-surgical-and-dental<\/span><\/a>. March 18, 2020. Accessed: April 12, 2020.<\/span><\/li>\n
  6. Ravindranath M. Senators push for permanent telehealth changes. <\/span>https:\/\/www.politico.com\/newsletters\/morning-ehealth\/2020\/06\/15\/senators-push-for-permanent-telehealth-changes-788506<\/span><\/a>. June 15, 2020. Accessed: June 18, 2020.\u00a0<\/span><\/li>\n<\/ol>\n

     <\/p>\n

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    In response to the covid-19 pandemic, US Health and Human Services (HHS) Secretary, Alex Azar declared a public health emergency on 31 January 2020. On 13 March 2020, US President […]<\/p>\n

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