(April 3 – 9, 2020)

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Many federal agencies have weighed in with various waivers, policy statements and guidance regarding arrangements between and among health care providers and their patients to address the COVID-19 pandemic. These include several blanket waivers by CMS of sanctions under the Stark Law and an OIG Policy Statement declining to impose administrative sanctions under the Federal anti-kickback statute. These actions are helpful, but should not be a blanket license to ignore these laws. In this special podcast, HortySpringer partners Dan Mulholland and Henry Casale review the recent guidance, explain what you can and can’t do and look ahead to the potential for a tsunami of False Claims Act litigation once the pandemic subsides.

PODCAST:  Coronavirus Fraud and Abuse Issues —
PODCAST:  Protections and Pitfalls

PODCAST:           by  Dan Mulholland  and  Henry Casale


Governmental Agencies Issue Further Guidance in Response to COVID-19

Government agencies continued their efforts to provide COVID-19 guidance and resources to health care providers:

  • The Centers for Medicare and Medicaid Services (“CMS”) continues to host multiple COVID-19 related calls and podcasts each week. Recently posted items and topics of discussion include CMS’s weekly Stakeholder Call with Seema Verma, “Lessons from the Front Line” (with Seema Verma and Dr. Deborah Birx), waivers and new rules promoting flexibility, and changes to accelerated and advance payment programs.  Transcripts and audio of these events can be found here.
  • CMS released a series of updated infection control guidance documents for inpatient and outpatient care settings. Based on Centers for Disease Control and Prevention (“CDC”) guidelines, this updated guidance is designed to promote infection control in a variety of contexts, including patient triage, screening (including drive-through screenings), treatment, visitations, and staffing.
  • CMS published a Dear Clinician Letter that summarizes the steps that CMS has taken to ensure that the nation’s clinicians have maximum flexibility to reduce unnecessary barriers when caring for patients. The letter discusses such steps as emergency waivers, testing and claims reporting, expanded options for telehealth services, E-visits, virtual check-ins, and workforce flexibilities.  The letter also contains links to clinical and technical guidance resources.
  • CMS released a guidance document containing recommendations regarding the limitation of medical services that can be deferred, such as preventive medical services and non-emergent, elective treatments.
  • The Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) released a report detailing the challenges and needs faced by U.S. hospitals responding to the COVID-19 pandemic. Some of the challenges outlined in the report include shortages of testing supplies and personal protective equipment, difficulty maintaining staffing, difficulty maintaining and expanding capacity to treat patients, and anticipated shortages of respirators.  A summary of the report can be found here.
  • The OIG also released a policy statement indicating that it will exercise its enforcement discretion not to impose administrative sanctions under the federal anti-kickback statute for certain COVID-19 related remuneration arrangements covered by the HHS Secretary’s recent Blanket Waivers. Regarding the physician self-referral law, the policy statement notes that the “Blanket Waivers effectuate a waiver of certain sanctions that otherwise apply to violations of the physician self-referral law, if certain conditions are met.”  Stakeholders that have questions regarding the OIG’s application of its enforcement authorities and how it would view an arrangement that may implicate these authorities can submit inquiries here.
  • The HHS Office for Civil Rights (“OCR”) released its own notification announcing that it, too, will exercise its enforcement discretion. The OCR will not impose potential penalties for violations of certain Health Insurance Portability and Accountability Act provisions regarding the uses and disclosures of protected health information by business associates for public health and health oversight activities during the COVID-19 public health emergency.  More information can be found here.
  • The CDC issued a recommendation for the use of cloth face coverings in public settings where other social distancing measures are difficult to maintain. This is especially important in areas of significant community-based transmission.  The recommended face coverings are not surgical masks or N-95 respirators.  Rather, the CDC indicates that “face coverings fashioned from household items or made at home from common materials at low cost can be used as an additional, voluntary public health measure.”

Joint Commission Updates Standards FAQ Database

The Joint Commission has updated its hospital and critical access hospital Standards FAQ databases with additional information regarding COVID-19.  Topics include the decontamination of single-use respirators, FPPE and OPPE requirements while operating under an emergency operations plan, the requirements for granting privileges to volunteer licensed independent practitioners during an emergency or disaster situation, the deferment of medical imaging equipment performance evaluation requirements, and locating CMS 1135 waiver information.

The Joint Commission has also written blog posts on the conservation of face masks and respirators during a shortage, personal protective equipment considerations, and the duration of disaster privileges.