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Legal Insights and Perspectives for the Healthcare Industry

Powerfully illustrating the efforts of the US Department of Health and Human Services (HHS) to transform the US healthcare system to a value-based model, the Office of the Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS) have finalized rules that will alter critical healthcare fraud and abuse regulations to remove or diminish obstacles to value-based enterprises that meaningfully embrace patient care coordination. The rule changes will transform fraud and abuse compliance and accelerate what HHS calls the “Regulatory Sprint to Coordinated Care Initiative.”

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.

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 Centers for Medicare and Medicaid Services (CMS) recently announced that it intends to resume both prepayment and postpayment medical reviews conducted by the Medicare Administrative Contractors, Supplemental Medical Review Contractors, and Recovery Audit Contractors, including those under the Targeted Probe and Educate program, on August 3, 2020:

Congressional stimulus packages appropriated $175 billion in relief funds under the CARES Act and the Paycheck Protection Program and Health Care Enhancement Acts for the benefit of hospitals and other healthcare providers in response to losses incurred due to the coronavirus (COVID-19) pandemic.

CMS posted an expanded set, dated April 29, of Medicare regulatory flexibility measures for hospice organizations related to the coronavirus (COVID-19) pandemic, supplementing the previous COVID hospice flexibilities guidance from March 29.

CMS recently issued Frequently Asked Questions (FAQs) clarifying requirements and considerations for hospitals and other providers related to the Emergency Medical Treatment and Labor Act (EMTALA) during the coronavirus (COVID-19) pandemic. The FAQs address questions concerning patient presentation to the emergency department, EMTALA applicability across facility types, qualified medical professionals, medical screening exams, patient transfer and stabilization, and telehealth issues.

The Centers for Medicare and Medicaid Services (CMS) issued an Open Payments COVID-19 Announcement on March 25 saying that it planned in some cases to exercise enforcement discretion with respect to late or incomplete data reporting. CMS stated that, although it is sensitive to the challenges caused by the coronavirus (COVID-19) pandemic, it does not have the authority to waive the statutory requirement that Program Year 2019 Open Payments data be submitted by the March 31, 2020, deadline or to postpone the publication deadline of June 30, 2020. CMS will, however, “exercise enforcement discretion with respect to submissions completed after the statutory deadline due to circumstances beyond the reporting entity’s control associated with the pandemic,” and will consider the impact that these circumstances have on reporting entities’ ability to report in a timely, accurate, and complete manner in deciding whether to impose civil monetary penalties.