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Volume XI, Number 217

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Connect for Health Act of 2021 Reintroduced

On 29 April 2021, Senator Brian Schatz (D-HI) reintroduced the Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2021, S. 1512 (the Act).1 The bill, which currently has 59 cosponsors in the Senate,2 aims to codify the currently expanded access to telehealth services provided for by the current Section 1135 waivers due to the COVID-19 public health emergency (PHE), in addition to other measures that support the provision of telehealth care. Prior to implementation of the Section 1135 waivers, telehealth visits were only reimbursable by Medicare under narrow circumstances, including the requirements that the services generally be provided in a designated rural area and from a qualifying originating site, which did not include a beneficiary’s home.3

BACKGROUND AND CONGRESSIONAL FINDINGS

Senator Schatz has introduced the Act in some form each session since 2016, but each time with the stated goal of reducing barriers to accessing telehealth services. This year, the effort is buoyed by the increased utilization of telehealth services during the PHE. After over a year of patients accessing quality care under the current waivers, the case for making the changes permanent is much easier to make. At this time, the text of the legislation has not been made publicly available, but the bill has been referred to the Senate Committee on Finance. Representative Mike Thompson (D-CA-5) has introduced the House of Representatives counterpart, where it is currently under review by the Committee on Finance.4

The findings in the Act acknowledge the value of telehealth services, including expanded access to health care, improved quality of care, reduced costs, and strengthening of the health care workforce expertise. The successful expansion of telehealth services during the COVID-19 PHE appears to have also heavily influenced the revised bill. In particular, the bill specifically states that the COVID-19 PHE demonstrated the benefits of telehealth, including reducing risk of infection for patients and providers and conserving space in facilities, and noted that the Centers for Disease Control and Prevention has recommended that “telehealth services should be optimized, when available and appropriate, during the pandemic.”5

REMOVING BARRIERS TO TELEHEALTH COVERAGE

The Act, which is also supported by over 150 advocacy and health organizations, acknowledges that practitioners can provide high-quality telehealth services in a safe and effective manner. As such, the legislation primarily seeks to promote higher quality of care, expanded access to telehealth services, and reduced Medicare spending through relaxation of current reimbursement rules and expanded coverage of additional telehealth services.

Specifically, the Act would amend the Social Security Act to promote the continued expansion of telehealth services by providing for the following:

  • Permanently removing all geographic restrictions on telehealth services;

  • Expanding the definition of originating site to include the home of an individual and granting the secretary additional flexibility to establish other sites as originating sites where deemed appropriate;

  • Removing restrictions on the use of telehealth in emergency medical care;

  • Requiring revisions to current process to add telehealth services in order to prioritize the addition of services that provide improved access to care;

  • Permitting temporary coverage of certain telehealth services, in order to determine the potential benefit of covering such telehealth services permanently;

  • Permanently adding federally qualified health centers and rural health clinics as eligible distant site providers;

  • Removing restrictions on Indian Health Service and Native Hawaiian health care system facilities; and

  • Allowing for recertification of hospice beneficiaries via telehealth.

The proposed Act also provides the Department of Health and Human Services (HHS) secretary with permanent authority to waive certain requirements for reimbursement of telehealth, including a qualifying originating site, geographic location requirements, limitations on the type of technology used, limitations on the types of practitioners that can furnish telehealth services, and limitations on the types of services provided via telehealth, subject to a finding that such waivers would adversely impact quality of care. 

The Act also requires the implementation of processes for public comment and periodic review and reassessment of such waivers, as well as public reporting on the impact and number of beneficiaries benefitting from the waivers.

Note that the expansion of Medicare reimbursement under the Act does not otherwise preempt licensure or geographic, technology or patient informed consent requirements that individual state licensing boards and other regulatory authorities may impose on licensed practitioners or change whether the appropriate standard of professional care is able to be met through a telemedicine encounter.

PROGRAM INTEGRITY

The Act includes multiple provisions to ensure program integrity by providing additional funding to the HHS office of Inspector General (OIG) for oversight of telehealth services through audits, investigations, and other oversight and enforcement activities. In addition, the Act establishes that the provision of technology to Medicare beneficiaries for the purpose of telehealth services, remote patient monitoring, and other digital health services is not considered “remuneration” under the prohibition on inducements provision of the Civil Monetary Penalties Law, provided certain conditions are met. Finally, the Act requires the Secretary to make available provider and beneficiary education resources on telehealth, including on reimbursement requirements, telehealth-specific privacy and security, and utilizing telehealth to engage and support underserved and high-risk populations.

DATA AND TESTING OF MODELS

The Act requires the Secretary to collect and analyze qualitative and quantitative data on the impact of telehealth services and other services utilizing digital health technology permitted under the COVID-19 PHE waivers and provided under alternative payment models and to report to Congress on the conclusions resulting from the collection and analysis of such data. Finally, the Act authorizes a testing model to evaluate allowing additional health care practitioners to provide telehealth services and encourages the Centers for Medicare & Medicaid Services Innovation Center to develop and test telehealth models under the Medicare program.

1 See CONNECT for Health Act of 2021, S. 1512, 117th Cong. (2021)

2 See id

3 See 42 U.S.C. 1395m(m)(4).

4  See CONNECT for Health Act of 2021, H.R. 2903, 117th Cong. (2021) To amend title XVIII of the Social Security Act to expand access to telehealth services, and for other purposes

5 Id § 2(a)(7).

Copyright 2021 K & L GatesNational Law Review, Volume XI, Number 173
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Gina Bertolini Healthcare Lawyer K&L Gates Law Firm Research Triangle Park North Carolina
Partner

Gina Bertolini is a partner in the Research Triangle Park officer and concentrates her practice exclusively on health law; primarily representing academic medical centers, hospitals, and health systems. She counsels senior health system and academic medical center leadership on a variety of governance, transactional, operational, and regulatory matters. In this context, she advises hospital, health system, and academic medical center clients on a multitude of legal matters, including state and federal regulatory affairs, such as federal Stark and anti-kickback statutes, EMTALA, HIPAA, and...

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Leah D'Aurora Richardson Health Care Attorney K&L Gates Research Triangle Park, NC
Partner

Leah D’Aurora Richardson is a partner in the firm’s Research Triangle Park office. Ms. D’Aurora Richardson advises academic medical centers, health systems, hospitals, hospices, and ancillary service providers, such as pharmacies, and durable medical equipment suppliers and clinical laboratories, on all areas of transactional and regulatory health law, including:

  • Responding to governmental investigations related to healthcare regulatory matters, including Anti-Kickback Statute and Stark Law compliance, and complex billing matters.
  • Compliance with...
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Sarah D. E. Staples Healthcare Attorney K&L Gates Nashville
Associate

Sarah Staples is an associate in the firm’s Nashville office and is a member of the Health Care and FDA practice group.

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