June 02, 2020

Re-Opening Safely in the Time of COVID-19: Physician Guidance for Deciding Whether to Reopen and How to Reopen

By Nalini K. Pande, Esq., Sappho Health Strategies, Arlington, Virginia

On March 13, 2020, President Trump declared a national emergency concerning the Novel Coronavirus Disease (COVID-19) outbreak.1 Citing the March 11, 2020 World Health Organization announcement that the COVID-19 outbreak could be considered a pandemic, the President highlighted that it was “incumbent on hospitals and medical facilities throughout the country to assess their preparedness posture and be prepared to surge capacity and capability.”2

Early CMS Guidance

In an effort to conserve critical healthcare resources in the early stages of the pandemic, and limit the exposure of patients and staff to the virus, on March 18, 2020 the Centers for Medicare & Medicaid Services (CMS) recommended that all elective surgeries and non-essential medical, surgical, and dental procedures be delayed during the 2019 COVID-19 outbreak.3  On April 7, 2020, CMS updated its guidance with a three-tiered framework.  The framework limited non-emergent, non-essential care for patients of all ages and emphasized the importance of reducing both the exposure of patients and staff to the virus and the burden on the existing health system:  

  • Tier 1: Low acuity treatment would warrant telehealth or postponement of treatment;
  • Tier 2: Intermediate acuity would warrant an initial evaluation via telehealth, and then triage accordingly; and
  • Tier 3: High acuity would warrant not postponing treatment, and instead triage to appropriate facility/level of care as necessary.4

The April 7, 2020 guidance also included key considerations:

  • Current and projected COVID-19 cases in the community and region;
  • Ability to implement telehealth, virtual check-ins, and/or remote monitoring;
  • Supply of personal protective equipment (PPE) available at the practice location and in the region;
  • Staffing availability;
  • Medical office/ambulatory service location capacity;
  • Testing capability in the local community;
  • Health and age of each individual patient and the patient’s risk for severe disease; and
  • Urgency of the treatment or service.5

While CMS acknowledged that state and local officials as well as clinicians providing care must make all final decisions, the agency emphasized the importance of conserving health system capacity in the event of a surge.6

Current CMS April 19, 2020 Guidance

By April 19, 2020, CMS recognized that many areas had a low or relatively low incidence of COVID-19 and wanted to allow for flexibility in resuming non-emergent care that had been postponed.  CMS provided recommendations on providing non-emergent, non-COVID-19 healthcare, with many caveats.

April 19, 2020 Guidance Will Not Apply to All Regions

CMS emphasized that governors and local leaders need to make the ultimate decision as to whether its guidance is appropriate for their communities.  CMS also stressed that its April 19, 2020 recommendations are not meant to be applied to every state or region at this time. In fact, CMS encouraged healthcare facilities and other providers that are in areas with a high number of COVID-19 cases to continue to implement the April 7, 2020 three-tiered framework. As highlighted above, the April 7 recommendations were issued to “expand capacity to care for patients with COVID-19, to reduce the risks of transmission, and exposure to patients, and to conserve adequate supplies, especially PPE and manpower, during the public health emergency.” 7

CDC Gating Criteria for Phase I

The new CMS April 19, 2020 recommendations are specifically targeted to communities that meet Phase I of the Guidelines for Opening Up America Again.8  In highlighting “Phase I,” CMS referenced the White House Guidelines and Centers for Disease Control and Prevention’s (CDC) three-phased approach to re-opening America.9 This three-phased approach is meant to be implemented statewide or on a community basis at state governors’ discretion.  The CDC has listed six indicators, also termed “gating criteria,” for states to use in determining whether to move into each phase.  The gating criteria provide measurable indicators and thresholds for communities to meet before proceeding to Phase I, II and III.  For example, prior to entering Phase I, states or regions need to pass the first set of gating criteria as described below in Figure 110 regarding symptoms, cases, and hospitals.11

Figure 1: Gating Criteria Must Be Met Before Proceeding to Phase I12

Symptoms

Cases

Hospitals

Downward trajectory or near-zero incidence of influenza-like illnesses (ILI) reported within a 14-day period

 

Downward trajectory or near-zero incidence of documented cases within a 14-day period

Capacity to treat all patients without crisis care: inpatient and intensive care unit (ICU) beds <80% full, no staff shortage in the last week and adequate PPE supplies for >4 days)

AND Downward trajectory or near-zero incidence of COVID-like syndromic cases reported within a 14-day period

OR Downward trajectory (or near-zero percent) of positive tests as a percent of total tests within a 14-day period (flat or increasing volume of tests)

AND Robust testing program in place for at-risk healthcare workers, including emerging antibody testing (percentage of positive tests is ≤20% for 14 days; median time from test order to result is ≤ 4 days)

Regions that Have Met the Gating Criteria Move Into Phase I: CMS April 19, 2020 Guidance Applies

For states or localities that have passed the first set of gating criteria, and have entered Phase I, the CMS April 19, 2020 guidance applies with regard to re-opening physician practices and facilities for non-emergent care.  Even so, CMS first emphasizes in its April 19, 2020 recommendations that these regions should continue to use telehealth modalities as appropriate.13 CMS also recommends that physicians and facilities focus on key planning considerations before re-opening:

  • Adequate facilities, workforce, testing, and supplies; and
  • Adequate workforce across phases of care (such as availability of clinicians, nurses, anesthesia, pharmacy, imaging, pathology support, and post-acute care).14

Further, CMS highlights the following general considerations:

  • Assess incidence and trends in conjunction with state and local public health officials;
  • Evaluate the necessity of the care based on clinical needs (prioritize surgical/procedural care and high-complexity chronic disease management, select preventive service may be necessary);
  • Consider establishing Non-COVID Care (NCC) zones that would screen all patients, all staff and those who enter the area; and
  • Ensure sufficient resources are available to the physician practice or facility across phases of care, including PPE, a healthy workforce, facility safety protocols, sanitation protocols, adequate supplies, testing capacity, and post-acute care, without jeopardizing surge capacity.15

CMS also advises physicians to make decisions that are in accordance with public health information and state public health officials.  For example, many states have adopted their own requirements on how and when physician practices should re-open in their state.  On May 18, 2020, Washington State’s  Governor issued a Proclamation (retroactive to midnight on May 17, 2020) allowing the resumption of non-emergent care.16  The Proclamation provided detailed criteria on how to resume non-emergent procedures, emphasizing the importance of conservation of PPE, use of telemedicine, key safety protocols, continuous monitoring of healthcare system and resource capacity, as well as the importance of operationalizing the expansion and contraction of care plans.17  Similarly, on May 21, 2020, Michigan’s Governor issued an Executive Order allowing the resumption of non-emergent care, effective May 29, 2020.18 The Executive Order provided detailed requirements on social distancing in waiting rooms, special hours for more vulnerable patients, screening protocols, and the use of telehealth, as well as cleaning and building disinfection protocols.19

Most importantly, CMS recommends that states and regions that are in Phase I continuously assess whether their communities remain at a low risk of incidence.  CMS cautions that these communities may need to once again postpone non-essential procedures if there is a surge.20

AMA Guidance

The American Medical Association (AMA) has put forth its own guidance on physician practices re-opening. First, the AMA Guide focuses on complying with all federal, state and local guidance, including the CDC gating criteria and the CMS guidance discussed above.21 Second, the AMA provides a detailed checklist that highlights the following key considerations for practices once their region passes the gating criteria and enters Phase I: 

  • Institute safety measures for patients;
  • Ensure workplace safety for clinicians and staff;
  • Screen employees for high temperatures and other symptoms of COVID-19;
  • Maintain records of employee screening results in a confidential employment file (separate from the personnel file);
  • Implement a tele-triage program;
  • Re-direct COVID, emergent care patients to a testing site or to a hospital (as appropriate); and
  • Screen patients before in-person visits.22

AMA’s Key Considerations

The AMA checklist also notes the importance of reviewing medical malpractice liability with insurance carriers to discuss current coverage and whether any additional coverage may be warranted. Further, the AMA checklist highlights the importance of workplace safety and employment law considerations.  Finally, the AMA recommends establishing confidentiality and privacy/data security protocols. It is important to remember that Health Insurance Portability and Accountability Act (HIPAA) patient authorizations are needed before physicians can share HIPAA-protected information about patients with their employers.23 Similarly, coworkers and patients can be notified if they have come into contact with an employee who tests positive for COVID-19, but the identity and symptoms of the employee cannot be disclosed without the employee’s consent.24  While the Department of Health and Human Services’ (HHS) February 2020 guidance reiterates existing HIPAA permitted disclosures to public health authorities, HHS has not, to date, modified any HIPAA protections regarding patient authorization requirements for physician disclosures to employers in light of COVID-19.25  However, it is critical to continue to monitor this issue for any new, interim guidance given the changing policy landscape.

Key Takeaways

As physicians and facilities focus on re-opening for non-emergent care, it is critical to ask, “what is the standard of care for these patients at this time”?  The CMS guidance (both April 7, 2020 and April 19, 2020 requirements), CDC recommendations, and the AMA Guide provide key insights and considerations. Ultimately, physicians and facilities should consider regularly reviewing federal, state and local requirements as well as any new interim guidance. Most importantly, all practices and facilities that enter Phase I (and future Phases) should frequently assess whether their region remains at a low risk of incidence and should be ready to stop non-essential procedures if a surge occurs. Accordingly, the path to re-opening may not be a straight line forward.  Rather, states and regions may take one step forward and then one step backward, depending on whether a surge occurs.  Continuously monitoring and assessing the gating criteria is critical for any plan to re-open for non-emergent care to conserve limited health resources, prevent the spread of the virus, and reduce the overall burden on the health system.

The information in this article focuses on states and regions entering or currently in Phase I of the Gating Criteria. Since this article has been finalized, additional CMS guidance published on June 8, 2020, provides information for states and regions that satisfy the Phase II Gating Criteria.  For those states and regions that are currently entering Phase II, this additional CMS guidance should also be considered.26

  1. Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak (Mar. 13, 2020), available at https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.
  2. Id.
  3. Centers for Medicare & Medicaid Services, Press Release, “CMS Releases Recommendations on Adult Elective Surgeries, Non-Essential Medical, Surgical, and Dental Procedures During COVID-19 Response” (Mar. 18, 2020), available at https://www.cms.gov/newsroom/press-releases/cms-releases-recommendations-adult-elective-surgeries-non-essential-medical-surgical-and-dental.
  4. Centers for Medicare & Medicaid Services, “Non-Emergent, Elective Medical Services, and Treatment Recommendations” (Apr. 7, 2020), available at https://www.cms.gov/files/document/cms-non-emergent-elective-medical-recommendations.pdf.
  5. Id.
  6. Id.
  7. Centers for Medicare & Medicaid Services, Press Release, “CMS Issues Recommendations to Re-Open Health Care Systems in Areas with Low Incidence of COVID-19” (Apr. 19, 2020), available at https://www.cms.gov/newsroom/press-releases/cms-issues-recommendations-re-open-health-care-systems-areas-low-incidence-covid-19.
  8. Id.
  9. Id.; White House Guidelines, “Opening Up America Again” (last accessed May 17, 2020), available at https://www.whitehouse.gov/openingamerica/; Centers for Disease Control and Prevention, Coronavirus Disease 2019 (COVID-19) Response, “CDC Activities and Initiatives Supporting the COVID-19 Response and the President’s Plan for Opening America Up Again” (May 2020), available at https://www.cdc.gov/coronavirus/2019-ncov/downloads/php/CDC-Activities-Initiatives-for-COVID-19-Response.pdf.
  10. Source: Centers for Disease Control and Prevention, Coronavirus Disease 2019 (COVID-19) Response, “CDC Activities and Initiatives Supporting the COVID-19 Response and the President’s Plan for Opening America Up Again” (May 2020), available at https://www.cdc.gov/coronavirus/2019-ncov/downloads/php/CDC-Activities-Initiatives-for-COVID-19-Response.pdf; White House Guidelines, “Opening Up America Again” (last accessed May 17, 2020), available at https://www.whitehouse.gov/openingamerica/.
  11. Centers for Disease Control and Prevention, Coronavirus Disease 2019 (COVID-19) Response, “CDC Activities and Initiatives Supporting the COVID-19 Response and the President’s Plan for Opening America Up Again” (May 2020), available at https://www.cdc.gov/coronavirus/2019-ncov/downloads/php/CDC-Activities-Initiatives-for-COVID-19-Response.pdf; White House Guidelines, “Opening Up America Again” (last accessed May 17, 2020), available at https://www.whitehouse.gov/openingamerica/.
  12. Id.
  13. Centers for Medicare & Medicaid Services, “Opening Up America Again: Centers for Medicare & Medicaid Services (CMS) Recommendations Re-opening Facilities to Provide Non-emergent Non-COVID-19 Healthcare: Phase I” (Apr. 19, 2020), available at https://www.cms.gov/files/document/covid-flexibility-reopen-essential-non-covid-services.pdf.
  14. Id.
  15. Id.
  16. State of Washington, Office of the Governor, “Proclamation by the Governor Amending and Extending Proclamations 20-05 and 20-24, 20-24.1, Reducing Restrictions on, and Safe Expansion of, Non-Urgent Medical and Dental Procedures” (May 18, 2020), available at https://www.governor.wa.gov/sites/default/files/20-24.1%20-%20COVID-19%20Non-Urgent%20Medical%20Procedures%20Ext%20.pdf.
  17. Id.
  18. Office of Governor Gretchen Whitmer, Executive Order 2020-97 (COVID-19), “Safeguards to Protect Michigan’s Workers from COVID-19, Rescission of Executive Order 2020-91” (May 21, 2020), available at https://www.michigan.gov/whitmer/0,9309,7-387-90499_90705-529864--,00.html.
  19. Id.
  20. Centers for Medicare & Medicaid Services, “Opening Up America Again: Centers for Medicare & Medicaid Services (CMS) Recommendations Re-opening Facilities to Provide Non-emergent Non-COVID-19 Healthcare: Phase I” (Apr. 19, 2020), available at https://www.cms.gov/files/document/covid-flexibility-reopen-essential-non-covid-services.pdf.
  21. American Medical Association, “A Physician Practice Guide to Reopening” (May 1, 2020), available at https://www.ama-assn.org/system/files/2020-05/physican-guide-reopening-practices-covid-19.pdf.
  22. Id.
  23. U.S. Department of Health and Human Services, Office for Civil Rights, “Employers and Health Information in the Workplace” (June 16, 2017), available at https://www.hhs.gov/hipaa/for-individuals/employers-health-information-workplace/index.html. (“[Under HIPAA,] if your employer asks your health care provider directly for information about you, your provider cannot give your employer the information without your authorization unless other laws require them to do so”), citing 45 C.F.R. §§ 160.103, 164.512(b)(1)(v); 45 C.F.R. 65 Fed. Reg. 82592 (Dec.28, 2000) (“Covered entities may disclose protected health information about individuals who are members of an employer’s workforce with an authorization.”) (emphasis added); American Medical Association, “A Physician Practice Guide to Reopening” (May 1, 2020), available at https://www.ama-assn.org/system/files/2020-05/physican-guide-reopening-practices-covid-19.pdf. Certainly, disclosure by a physician to an employer is permitted if the care of the employee is at the request of the employer in certain circumstances, such as a workplace illness or injury.  45 C.F.R. §§ 160.103, 164.512(b)(1)(v) (Disclosure to an employer is permitted if the care of the patient was at the request of the employer to conduct an evaluation relating to medical surveillance of the workplace or evaluating whether the individual has a work-related illness or injury).
  24. Id.
  25. U.S. Department of Health and Human Services, Office for Civil Rights, “BULLETIN: HIPAA Privacy and Novel Coronavirus” (Feb. 2020), available at https://www.hhs.gov/sites/default/files/february-2020-hipaa-and-novel-coronavirus.pdf.
  26. Centers for Medicare & Medicaid Services, “Centers for Medicare & Medicaid Services (CMS) Recommendations Re-opening Facilities to Provide Non-emergent Non-COVID-19 Healthcare” (June 8, 2020), available at  https://www.cms.gov/files/document/covid-recommendations-reopening-facilities-provide-non-emergent-care.pdf.

About the Author

Nalini Pande, Managing Director, Sappho Health Strategies, LLC, has nearly 25 years of experience in health policy and health reform.  She also has considerable experience in public health. She has worked as a consultant to the Obama Administration on health reform, emergency preparedness, and projects focused on improving the healthcare infrastructure, as well as special rules related to national emergencies and pandemic flus. She has also worked as a consultant to the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the United States Department of Health and Human Services. She previously worked at The Lewin Group as well as Foley & Lardner and Crowell & Moring.  Ms. Pande also taught an advanced graduate course in health policy at Georgetown University as an Adjunct Professor. Ms. Pande is a graduate of Harvard Law School and Princeton's Woodrow Wilson School of Public and International Affairs.  She may be reached at nkpande@sapphohealth.com.