Medicine in the Time of COVID

Introduction

Just as the 1793 Yellow Fever outbreak in Philadelphia and the Spanish Flu Pandemic changed medicine, public health, and society, the COVID-19 pandemic is changing the practice of medicine. Some of these changes are likely to persist over the long term. This article provides a brief summary of some of the key changes in the laws and behaviors impacting current practice, and some guesses as to which of those changes are likely to persist.

Executive Orders and the Practice of Medicine

Current Impact. Since March 19, 2020 (1), Governor Ducey has issued nearly fifty Executive Orders relating to COVID-19. Several of these orders affected the practice of medicine. For example, one of the Orders (2) required physicians to delay “non-essential or elective surgery”; a subsequent Order (3) directed the Arizona Department of Health Services to establish rules regarding whether and under what circumstances those surgeries could be provided.

Long-Term Impact? Although these Executive Orders and similar orders issued by other executives are likely to be the subject of many policy papers and Law Review articles, addressing whether the orders exceeded the executives’ legal authority, there have been few if any challenges to the orders. This may be a consequence of the dire circumstances in which the orders were issued. In any event, it seems likely that the issuance of these orders will have little if any impact on the practice of medicine over the long term.

Regulatory Relief

Current Impact. Several federal agencies have relaxed the restrictions their regulations impose on physicians. (4) For example, CMS initiated its Patients over Paperwork program, which directed federal agencies to “‘cut the red tape’ to reduce burdensome regulations.” (5) Among other things, this program temporarily relaxed: restrictions imposed under the “Stark law”; coverage restrictions imposed under NCDs and LCDs (6) relating to items or services used to treat COVID-19 patients; signature and proof of delivery requirements for Part B drugs and durable medical equipment; and, a host of requirements and restrictions relating to telemedicine. The DHHS Office for Civil Rights, which enforces HIPAA, also relaxed rules relating to enforcement (see, e.g., the discussion below regarding telehealth).

Long-Term Impact? A permanent relaxation or elimination of these restrictions probably would require cooperation between the two political parties and their appointees. A belief that the necessary cooperation will occur probably requires a triumph of hope over experience. Therefore, with the possible exception of telehealth, described below, long-term changes regarding regulatory relief do not seem likely.

Liability Relief

Current Impact. There have been several state and federal initiatives that purport to provide liability protections for physicians and others involved in the delivery of health care. For example, one of Governor Ducey’s Executive Orders (7) states that health care professionals acting “in the course of providing public health services in support of the State’s public health emergency for COVID-19 [are] presumed to have acted in good faith and [are] immune from civil liability.”

At the federal level, the DHHS Secretary signed a Declaration expanding the liability protections established in the Public Readiness and Preparedness Act (passed in 2005 to protect vaccine manufacturers). The Declaration gives licensed health care providers qualified immunity, under state and federal law, for vaccine-related activities undertaken in connection with COVID-19.

Long-Term Impact? Even if these efforts withstand challenges by personal injury attorneys, and the resulting judicial review, physicians have rarely succeeded in limiting their liability for patient care activities. Consequently, it seems unlikely that these changes will have a lasting impact.

Telehealth

Current Impact. Of all the relief efforts undertaken by governmental agencies in response to COVID-19, those taken by agencies regulating telehealth have been the most extensive. For its part, CMS drastically (if only temporarily) revised its telemedicine rules on many fronts. (8) Under the revised rules, physicians can: provide telehealth services to new and established patients, regardless of patient location; waive copays; use audio-only technology; provide an expanded menu of services; receive the same reimbursement applicable to in-person visits; provide telemedicine services without regard to frequency limitations; and supervise ancillary staff via telemedicine.

The Office for Civil Rights has determined that it will “exercise its discretion not to impose penalties … in connection with the good faith provision of telehealth” during the pandemic. (9) At the state level, Governor Ducey has issued Executive Orders facilitating the use of telemedicine, and requiring parity for telemedicine reimbursement. These Orders apply to physicians and others involved in a range of health services, (10) including workers’ compensation (11) and even veterinary medicine. (12)

These changes and other factors have resulted in a tremendous increase in both the volume and scope of telemedicine services being delivered. According to one report, “[b]efore the public health emergency, approximately 13,000 beneficiaries in fee-for-service (FFS) Medicare received telemedicine in a week. In the last week of April, nearly 1.7 million beneficiaries received telehealth services.” (13)

Long-Term Impact? Even before the pandemic, patients generally seemed to accept and even embrace the concept of telemedicine. For example, a 2019 JD Power report on telehealth services, found customer satisfaction for telehealth services had an overall ranking of 852 (out of 1000). (14) This was among the highest satisfaction levels in all J.D. Power studies of the healthcare, insurance and financial services industries. The same report notes that one of the barriers to adoption of telemedicine is that “[p]roviders struggle with awareness and adoption.”

Given patients’ favorable attitudes towards telemedicine, and the meteoric rise in its use during the pandemic, it seems quite likely that an increase in the use of telemedicine will be an enduring outcome of the pandemic. Providers whose practices are not currently set up to meet patient demands for telemedicine should move quickly to remedy that gap in their offerings.

By Miranda A. Preston, JD, Associate Attorney, Milligan Lawless, P.C., miranda@milliganlawless.com

By Robert J. Milligan, JD, Shareholder, Milligan Lawless, P.C., bob@milliganlawless.com

Cited Sources: (Numbered in parentheses above)

1. https://azgovernor.gov/executive-orders.

2. Executive Order 2020-10; Delaying Elective Surgeries to Conserve Personal Protective Equipment Necessary to Test and Treat Patients

3. Executive Order 2020-32; Requesting Exemption From Executive Order 2020-10 — Elective Surgeries.

4. In addition, CMS implemented a Provider Relief Fund, which allocated $100 billion to reimburse providers for decreased revenue and increased expenses associated with the pandemic.

5. https://www.cms.gov/Outreach-and Education/Outreach/Partnerships/PatientsOverPaperwork.

6. An NCD, or National Coverage Determination, is a determination by DHHS with respect to whether or not a particular item or service is covered by Medicare. An LCD, or Local Coverage Determination, is a determination by a MAC with respect to whether or not a particular item or service is covered in the particular MAC’s geographic area.

7. The Good Samaritan Order — Protecting Frontline Healthcare Workers Responding To The COVID-19 Outbreak.

8. Physicians and Other Clinicians: CMS Flexibilities to Fight COVID-19. https://www.cms.gov/files/document/covid-19-physicians-andpractitioners.pdf.

9 https://www.hhs.gov/hipaa/for-professionals/special-topics/emergency-preparedness/notification-enforcement-discretion-telehealth/

10. Executive Order 2020-15, Expansion of Telemedicine.

11. Executive Order 2020-29, Increased Telemedicine Access for Workers’ Compensation.

12. Executive Order 2020-19, Telemedicine for Pets and Animals.

13. Verma, S, Early Impact Of CMS Expansion Of Medicare Telehealth During COVID-19, https://www.healthaffairs.org/do/10.1377/hblog20200715.454789/full/.

14. Telehealth: Best Consumer Healthcare Experience You’ve Never Tried, Says J.D. Power Study, BusinessWire, October 28, 2019.