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.