On March 17, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued a memorandum to provide information to organizations that participate in the Programs of All-Inclusive Care for the Elderly (“PACE”) program in furtherance of preventing the spread of the 2019 Novel Coronavirus (“COVID-19”).

Coronavirus, PACE Organizations COVID-19 Control and Prevention

Pursuant to 42 CFR 460.74, organizations that participate in PACE (“PACE Organizations”) are required to follow accepted infection control policies and procedures that, at a minimum, adhere to the guidelines developed by the Centers for Disease Control and Prevention (“CDC”).  PACE Organizations must also establish and maintain a documented infection control plan that ensures a safe and sanitary environment and prevents and controls the transmission of disease and infection.  The infection control plan must include: (1) procedures to identify, investigate, control and prevent infections in each PACE center and each PACE participant’s place of residence; (2) procedures to record any incidents of infection; and (3) procedures to analyze the incidents of infection to identify trends and develop corrective actions.  These obligations are not diminished by virtue of the spread of COVID-19.

Given the general infection control requirements imposed on PACE Organizations and the danger posed by the current COVID-19 pandemic to the elderly demographic served by the PACE program, the guidance issued by CMS recommends the following for PACE Organizations:

  1. PACE Organizations should monitor the CDC website and the CMS Emergency Preparedness & Response Operations website for the latest information and resources related to COVID-19, including guidance issued for home health agencies, dialysis facilities, nursing homes and hospice agencies.
  2. Pursuant to current CDC guidelines, health care providers should implement strategies for preventing the spread of COVID-19, including but not limited to, reviewing infection control practices with their staff, implementing proper hand and respiratory hygiene, monitoring participants, staff and visitors for fever and respiratory symptoms, using alcohol-based hand sanitizers and keeping all individuals including visitors, staff and participants home when they are ill.
  3. In furtherance of keeping staff home when ill, PACE Organizations should implement sick leave policies for staff that are non-punitive, flexible and consistent with public health guidance.
  4. Given the importance of detection, triage and isolation of potentially infectious PACE participants and staff to prevent the spread of COVID-19, PACE Organizations should frequently monitor for potential respiratory infection symptoms and follow state requirements in furtherance thereof.
  5. A PACE Organization that experiences a high number of respiratory illnesses among PACE participants or staff or suspects that a PACE participant or staff member has COVID-19 should immediately contract its state or local health department for further guidance.
  6. Recommended personal protective equipment (“PPE”) should be provided to PACE staff, who should be properly trained on PPE use.

Continued Obligation to Provide Care to PACE Participants

CMS notes that in accordance with their obligations under 42 CFR 460.92, PACE Organizations are responsible for providing all required Medicare and Medicaid covered services, including any diagnostic laboratory tests and professional medical services to maintain a participant’s overall health status in connection with the diagnosis and treatment of COVID-19.  This responsibility extends to the home setting even for PACE participants suspected of contracting COVID-19 who therefore should not go to the PACE center to obtain treatment.  However, in light of COVID-19, PACE center attendance can be limited to prevent potential exposure, including for PACE participants who do not show COVID-19 symptoms.

Relaxation of PACE Program Requirements

CMS acknowledges that given the gravity of the COVID-19 pandemic, there may be circumstances where a PACE Organization needs to implement strategies that do not fully comply with PACE program requirements.  For example, CMS recognizes the need for greater use of remote technology and telehealth for activities that would normally occur in person and consequently will take those situations into consideration when conducting monitoring or oversight activities.

CMS is also permitting PACE Organizations to relax “refill-too-soon” edits and provide maximum extended day supply, provide home or mail delivery of Medicare Part D drugs and waive prior authorization requirements at any time that they otherwise would apply to Medicare Part D drugs used to treat or prevent COVID-19, if or when such drugs are identified. CMS indicated that it will notify PACE Organizations through the Health Plan Management System when CMS is ending such enforcement discretion.

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After issuing the memorandum, CMS held a conference call for PACE Organizations and state agencies on COVID-19 in order to provide additional guidance and respond to questions.  On the conference call, CMS reiterated its acknowledgment that during the COVID-19 emergency, PACE Organizations may have to “implement strategies that do not fully comply with PACE requirements” and mentioned that further guidance may be issued in the future with respect to face-to-face requirements, employee/contractor background checks and flexibilities specific to both.[1]  Additional information about the conference call can be found here.

We will continue to monitor CMS guidance for PACE Organizations and health care providers.

This article is not an unequivocal statement of the law, but instead represents our best interpretation of where things currently stand. This article does not address the potential impacts of the numerous other local, state and federal orders that have been issued in response to the COVID-19 pandemic, but which are not referenced in this article.

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FOOTNOTES

[1] Brendan Flinn, “CMS Holds COVID-19 Call for PACE Organizations,” LeadingAge (March 25, 2020), https://leadingage.org/regulation/cms-holds-covid-19-call-pace-organizations.

*This alert is provided for information purposes only and does not constitute legal advice and is not intended to form an attorney client relationship.  Please contact your Sheppard Mullin attorney contact for additional information.*

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