Coronavirus

As many of you are aware, the Centers for Medicare and Medicaid Services (CMS) along with many states have waived licensing and other requirements to allow healthcare providers to use non-hospital space to treat COVID-19 and non-COVID-19 patients, conduct testing and perform other clinical operations.  Healthcare providers across the country are exploring options to increase…

We understand the growing concern surrounding Coronavirus Disease 2019 (COVID-19) and the issues and uncertainties many nonprofit organizations throughout the country are facing as a result of its impact on everyday life around the world.  From the most immediate issues – such as addressing workplace safety issues for employees and community stakeholders – to long term budgetary concerns – such as contingency planning for reduced funding due to the current bear market – we have provided a recap of the various issues the nonprofit executives should address.

On April 8, 2020, the U.S. Department of Health & Human Services (HHS) Office of the Assistant Secretary for Health released guidance authorizing pharmacists to order and administer COVID-19 tests.  Immediately following this guidance, on April 9, 2020, the HHS Office of Civil Rights (OCR) announced that it will exercise its enforcement discretion and will refrain from imposing penalties for violations of HIPAA for covered entities or business associates participating, in good faith, in the operation of COVID-19 Community-Based Testing Sites (CBTS) during the nationwide public health emergency.  The guidance regarding pharmacists testing for COVID-19 and the notice related to the relaxation of HIPAA rules comes on the heels of pharmacies, such as CVS and Walgreens, taking on a more active and critical role in the fight against the COVID-19 pandemic.

Centers for Medicare & Medicaid Services (CMS) held a Special Open Door Forum that was open to the public on April 8, 2020. CMS has been working to address the COVID-19 pandemic through 1) increasing hospital capacity, 2) rapid expansion of the healthcare workforce, 3) relaxing health care administrative requirements, and promoting the use of telehealth, which this call was focused on. The call provided an opportunity for health care providers to ask specific questions and express concerns about telehealth and Medicare reimbursement.

On Wednesday, April 8, 2020, the U.S. Department of Health & Human Services (HHS) Office of the Assistant Secretary for Health released guidance authorizing pharmacists to “order and administer COVID-19 tests, including serology tests, that the Food and Drug Administration (FDA) has authorized.”  HHS noted that it recognized that most Americans are relatively close to a retail pharmacy and they interact with pharmacists more frequently than other healthcare professionals. Allowing pharmacists to administer the tests should reduce travel to testing locations – an important mitigation step.  HHS Secretary Alex Azar issued the following statement:

The Centers for Medicare and Medicaid Services (“CMS”) confirmed that hospice physicians and nurse practitioners who serve as a patient’s attending physician (“NPs”) can use telehealth to perform medically necessary visits during the COVID-19 pandemic. To assist hospices in evaluating the feasibility of using telehealth for medically necessary visits with Medicare patients, Husch Blackwell has created a “Hospice Telehealth Flowchart.” The Flowchart addresses important operational considerations as well as the Medicare requirements related to rendering and billing for such telehealth visits.

On March 27, 2020, President Trump signed the Coronavirus Aid, Relief and Economic Security Act (the CARES Act) into law. Section 3221 of the CARES Act ratified fundamental changes to the Public Health Service Act, codified at 42 U.S.C. § 290dd-2 and associated regulations, which govern the confidentiality requirements of substance use disorder records, commonly known as 42 C.F.R. Part 2, or simply, “Part 2.” Substance use disorder (SUD) records are defined broadly as “[r]ecords of the identity, diagnosis, prognosis, or treatment of any patient which are maintained in connection with the performance of any program or activity relating to substance abuse education, prevention, training, treatment, rehabilitation, or research.” The changes are significant and align with the increasing movement to align the Part 2 rules with the Health Insurance Portability and Accountability Act (HIPAA). The CARES Act requires the Department of Health and Human Services (HHS) to revise the Part 2 regulations within 12 months to comply with the CARES Act.

On April 2, 2020, at the direction of the president, CMS issued additional guidance [https://go.cms.gov/2V1QBdM] regarding the mitigation of the spread of COVID-19 in the country’s nursing facilities. The guidance was apparently issued in response to recent onsite observations by CMS and CDC experts in nursing facilities. In short, the guidance addresses five key issues:

Change is fast-paced in the world of COVID-19. On Monday, March 30th, CMS released an interim final rule along with hospice specific waivers. In this episode, your Hospice Team discusses these recent developments and their impact on telehealth, face-to-face encounters, virtual visits and Medicare appeals and audits.

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The Families First Coronavirus Response Act (“FFCRA”) goes into effect today, April 1, 2020, and applies to leave taken between April 1, 2020 and December 31, 2020.  The FFCRA expands certain medical leave rights previously established by the Family and Medical Leave Act (“E-FMLA”) to provide up to twelve (12) weeks of paid, job-protected leave for employees with school closure or childcare coverage issues related to the current coronavirus pandemic.  The FFCRA also provides for two (2) weeks of paid sick leave under the Emergency Paid Sick Leave Act (“E-PSLA”) for certain COVID-19-related reasons (the E-FMLA and E-PSLA are collectively referred to as “Expanded Leave”).[1]  However, employers who employ “health care providers” may, but are not required to, exempt these individuals from Expanded Leave.  Most, if not all, of a hospice’s employees will fall within the broad definition of “health care provider.”  Therefore, hospices will need to evaluate who of its employees it will exempt or not, being certain to treat similarly situated employees equally and to consider the potential impact to its workforce.