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Legal Insights and Perspectives for the Healthcare Industry

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.

The coronavirus (COVID-19) pandemic has brought a dramatic shift from in-person healthcare visits to telehealth services around the world, unveiling a new normal for providing healthcare services. Our global healthcare industry team authored a LawFlash to highlight how regions, including the United States, China, Singapore, and the United Arab Emirates, around the world have quickly adapted to providing telehealth services as a means to prevent exposure to COVID-19 and allow for patients to get in the in-person care they need.

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Healthcare is a highly regulated space, and regulators are continuing to issue new policies and regulations to address the critical needs for goods and services to combat the coronavirus (COVID-19), while also protecting the public health. Companies beyond just healthcare and life sciences should be aware of the relevant regulatory and legal requirements to avoid enforcement and liability requests.

In this LawFlash, you will find an overview of key areas of law and regulation, including FDA regulation, product liability and the PREP Act, clinical testing oversight, digital health and telehealth, and healthcare regulation and reimbursement, that impact companies marketing products or services to support COVID-19 efforts.

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Much to the relief of the healthcare provider community, US Department of Health and Human Services (HHS) spokesperson Michael Caputo tweeted on Monday that HHS intended to extend the public health emergency that was declared earlier this year.