Update (June 12): The Centers for Medicare & Medicaid Services released Phase II recommendations for healthcare providers reopening for non-emergent, non-COVID-19-related services. For eight key considerations for healthcare providers based on those recommendations, see this June 12, 2020, McGuireWoods legal alert.
During this unprecedented public health emergency created by the novel coronavirus (COVID-19), in an effort to slow the spread, protect healthcare providers and consumers from exposure, and ensure healthcare resources remain available for urgent and emergency care, the Centers for Medicare & Medicaid Services (CMS) released recommendations on postponing adult non-essential medical, surgical and dental procedures.
In issuing these recommendations, CMS Administrator Seema Verma noted that “[t]he reality is clear and the stakes are high: we need to preserve personal protective equipment for those on the front lines of this fight.” CMS hopes to accomplish several key things by urging providers to postpone certain elective procedures, specifically: (i) preserve necessary equipment that healthcare providers need to address cases that are more urgent and combat COVID-19; (ii) free up healthcare providers to care for those who have contracted COVID-19; and (iii) slow the spread of the virus.
Undoubtedly, the COVID-19 pandemic and accompanying recommendations create both business and continuity-of-care concerns for healthcare providers, and this guidance challenges healthcare specialties that provide services CMS is now considering “non-essential.” In light of these recommendations, healthcare providers should note the following:
- Factors to Consider Before Proceeding. In working alongside the White House Task Force on COVID-19, CMS set forth various factors for healthcare providers to use in determining whether a planned procedure should continue. Among these factors are: (i) patient risk factors; (ii) availability of resources, such as beds, staff and personal protective equipment (PPE); (iii) procedure urgency; (iv) current and projected COVID-19 cases in the facility and region; and (v) ventilator availability. As noted above, CMS strongly encourages providers to consider whether the procedure would use PPEs that providers on the front line of the COVID-19 pandemic may need instead. CMS also reproduced a tiered framework for healthcare professionals to utilize when considering acuity and whether to postpone a procedure. A copy of this tiered framework is included in the CMS guidance.
- Providers Are Encouraged to Postpone Dental Procedures and Exams. In preparing these recommendations, CMS expressly stated that dental procedures pose one of the highest transmission risks due to the necessary use of PPE and close proximity of provider to patient and, accordingly recommends that all non-essential dental services be postponed “until further notice.” This guidance follows the American Dental Association’s (ADA) recommendation earlier this week that “dentists nationwide postpone elective procedures for the next three weeks.” The ADA has since provided additional guidance on what constitutes a dental emergency.
- Non-Binding Recommendations. CMS’ recommendations and guidance are not, at this time, binding. As CMS notes, while recommending postponement of most elective and non-essential medical, surgical and dental procedures, the decision to postpone a procedure ultimately remains at the local level with clinicians, patients, health systems and state/local health departments. There is not currently any federal prohibition against providing these non-elective procedures, and CMS has not announced any reimbursement adjustments for providers who elect to continue rendering procedures included in its framework. Instead, as Verma noted, CMS is asking providers to consider how these procedures could impact the wider community.
- Continue to Monitor Government Guidance. The Centers for Disease Control and Prevention similarly recommends prioritizing “urgent and emergency visits and procedures now and for the coming several weeks” to preserve necessary PPE supplies and ensure safety. In addition to the federal announcements, providers should monitor state and local developments to ensure there is no mandate to postpone elective procedures in their respective localities. For example, several states have halted certain elective surgeries, including but not limited to Minnesota, Ohio and Washington. Additionally, California Gov. Gavin Newsom issued an order for all individuals to stay home, and New York Gov. Andrew Cuomo ordered a similar business shutdown, after joining the governors of New Jersey, Connecticut and Pennsylvania to close all personal care services. Expect this list to grow in the days to come; state associations and boards are pushing for similar action.
- Expanded Telehealth Services. As discussed in a prior McGuireWoods legal alert, the unprecedented public health emergency created by COVID-19 has sparked action by the U.S. government to ensure greater access to healthcare via telehealth services (especially for high-risk Medicare beneficiaries) while simultaneously limiting the spread of COVID-19. States are following suit with similar actions to expand access to care through both Medicaid and commercial payors. This is a rapidly evolving area. Providers should consider engaging in telemedicine visits to continue assessing patients during this crisis and determine when a procedure may become more urgent.
- Practical Guidance. Providers and facilities that elect to continue offering elective procedures may consider amending their informed consent process and providing patients the option of rescheduling the procedure. With respect to the consent, providers may advise of additional risks related to undergoing a surgery during the COVID-19 pandemic. Providers may want to post signage advising of the same, requesting anyone with COVID-19-related symptoms not to enter and advising what to do in the case of an emergency. Further, providers should provide surgeries only where there is an adequate supply of PPE and very low risk that the patient may need a transfer to an inpatient facility or an ICU. Additionally, providers should continue to follow CDC and other applicable guidance to reduce the risk of COVID-19 spread, including its interim guidance for healthcare facilities, and proactively staying abreast of emerging insights and data from the CDC in this fluid situation. It is also recommended that providers confirm their malpractice and other insurance policies will not deny coverage in light of the CMS recommendations on postponement of non-essential procedures. Malpractice carriers may provide additional guidance that providers will want to follow in these circumstances.
- Impact on Licensure/Certification. Many providers facing the decision of whether, and how extensively, to limit elective procedures face the additional quandary of how their state licensure, certificates of need (CON), accreditations and Medicare/Medicaid certification will be impacted by a dramatic change in procedure volume and type. Many state licensure and CON regimes require continuous uninterrupted service and/or the maintenance of certain volumes and types of procedures. And, for hospitals, CMS requires that the hospital be “primarily engaged in providing services,” which, since Sept. 6, 2017, Interpretive Guidelines to Surveyors, has turned on an intricate analysis of the numbers and types of patients served and procedures provided in order for the hospital to remain eligible for Medicare certification. A dramatic shift away from certain elective procedures may leave many providers uneasy about the fate of their licensure/certification, despite CMS’ recent halt of non-emergency surveys. Expect to see additional softening of many of these historical rules, both from federal and state regulators, in an ongoing effort to encourage hospitals and similarly equipped providers to more comfortably shift their operations without the fear of reprisal.
Please contact the authors for additional information regarding these recommendations.
McGuireWoods has published additional thought leadership related to how companies across various industries can address crucial coronavirus-related business and legal issues, and the firm’s COVID-19 Response Team stands ready to help clients navigate urgent and evolving legal and business issues arising from the novel coronavirus pandemic.