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Legal Insights and Perspectives for the Healthcare Industry

Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), all pesticide products (including surface sanitizing products) must be registered with the Environmental Protection Agency (EPA) prior to sale, distribution, or use in the United States. EPA maintains a list of pesticide products that should kill the SARS-CoV-2 virus, called List N. EPA recently released new interim guidance allowing it to expedite review of some applications for new and amended registrations for products intended to kill SARS-CoV-2.

EPA now plans to expedite its review of the addition of residual efficacy claims for current or new registrations on List N, products that would qualify for List N, or products that can be used as a residual supplement for disinfecting products already on List N. Residual efficacy claims are essentially claims that a product has antimicrobial effects for extended periods of time—up to days, weeks, or even months.

Healthcare entities should be sure to use only List N products for any surfaces that need to be sanitized for SARS-CoV-2 exposure, and should be on the lookout in the future for any products that may be added to the list with residual sanitizing claims. Providers should also note that some surface sanitizing products may be subject to both EPA and FDA jurisdiction, and may potentially require FDA review. However, this interim guidance does not apply to products that are subject to FDA’s exclusive jurisdiction, like hand sanitizers.

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The US Department of Health and Human Services (HHS) issued two welcome announcements on October 22 relating to the CARES Act Relief Fund Provider Relief Fund (PRF). First, the agency expanded the pool of eligible recipients to “include provider applicants such as residential treatment facilities, chiropractors, and eye and vision providers that have not yet received Provider Relief Fund distributions.” The full list of providers eligible for PRF Phase 3 Payment application is listed on the HHS website, and HHS confirmed that these providers may apply “regardless of whether they accept Medicaid or Medicare.” (Read the announcement for more information.)

Our corporate and business transactions and finance teams published a LawFlash on the Small Business Administration’s (SBA) recent procedural notice to Paycheck Protection Program (PPP) lenders addressing the treatment of PPP loans in the context of a “change of ownership” of the borrower and whether prior SBA approval must be obtained in such transactions. This LawFlash provides key takeaways for healthcare clients and healthcare industry investors with respect to M&A transactions involving PPP borrowers.

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Readers may also be interested to read our LawFlash on California Could See Regulatory Scrutiny of Post-COVID-19 Healthcare Transactions.

In a stunning move, the Centers for Medicare and Medicaid Services (CMS) has linked reporting and tracking of the incidence and impact of the coronavirus (COVID-19) disease to satisfaction of the Medicare Conditions of Participation (CoPs) for hospitals and critical access hospitals, in spite of the federal about-face that has caused confusion concerning that same reporting since the inception of the pandemic.

CMS’s Interim Final Rule (IFR) applies to a large variety of healthcare and non-healthcare providers that are currently testing for coronavirus. Hospitals, employers, and other entities are struggling to ensure they comply with an ever-changing landscape of local, state, and federal reporting requirements. However, this recent IRF subjects these entities to fairly stout enforcement consequences for failure to stay current, comply, and perform. CMS released its IFR with comment for public display on August 25 with publication in the Federal Register on September 2, 2020. Comments are due 60 days after publication.

Our global healthcare industry team continues to highlight how regions around the world have quickly adapted to providing telehealth services following the coronavirus (COVID-19) pandemic. In Singapore, telehealth providers are mainly focused on providing remote telemedicine and/or on-demand house call services.

We invite you to join us on Tuesday, August 25 for our next installment of the Fast Break series, this time focused on fraud enforcement following the coronavirus (COVID-19) pandemic.

Our labor, employment, and benefits team recently posted a LawFlash on the ruling in federal district court in New York that invalidated significant parts of a US Department of Labor rule. The ruling found that more employees are eligible for up to 12 weeks’ coronavirus (COVID-19)-related emergency paid sick leave and emergency paid FMLA leave. In light of the court’s decision, employers should consider whether they need to adjust their leave determinations in light of the court’s decision.

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Imagine you are the primary caretaker for your 94-year-old terminally ill mother who lives in your home while under hospice care during the coronavirus (COVID-19) pandemic.

Overwhelmed, exhausted, and drained—or even exposed to COVID-19—you discuss caregiver break with the hospice social worker who suggests “respite stay” for your mother but says Medicare only covers respite services up to five days, and only when care is furnished in an inpatient facility, like a nursing home. You don’t want that option given your mother’s heightened risk of contracting COVID-19 in a facility.

US President Donald Trump issued an executive order on August 3 that aims to expand telehealth access to Medicare beneficiaries beyond the coronavirus (COVID-19) public health emergency (PHE) period. The executive order focuses on rural healthcare providers in particular, noting the difficulties patients in rural areas face in obtaining accessible, high-quality healthcare services over the years. The order contains four specific directives:

  1. The US Department of Health and Human Services (HHS) must create a new 1115A model to test payment mechanisms related to rural healthcare providers.
  2. HHS, the Federal Communications Commission, and the US Department of Agriculture must develop a strategy to improve rural health care through developing healthcare-related infrastructure.
  3. HHS must issue a report regarding existing and planned policy initiatives that enhance various rural healthcare quality metrics, including identifying “regulatory burdens that limit the availability of clinical professionals.”
  4. HHS must propose regulation that would extend the measures taken during the PHE beyond its current duration as to both “the additional telehealth services offered to Medicare beneficiaries” and “the services, reporting, staffing, and supervision flexibilities offered to Medicare providers in rural areas.”

The coronavirus (COVID-19) pandemic has created unforeseen and unavoidable circumstances within the healthcare industry that may provoke further crisis for hospitals, nursing homes, physicians, and other frontline healthcare providers in the form of potential liability claims for noncompliance with COVID-19 protocols or other standards. In response to the pandemic, the US Department of Health and Human Services (HHS) has expanded the Public Readiness and Emergency Preparedness (PREP) Act’s immunity protection.