By David B. Bailen

Upon the declaration of the COVID-19 Public Health Emergency (“PHE”), the Centers for Medicare & Medicaid Services (“CMS”) used emergency waiver authorities and regulatory authorities to suspend or relax certain statutory and regulatory requirements. This relaxation was accomplished through waivers, which were enacted with the intention of empowering providers to respond to and address patient needs more rapidly during the PHE. Health care providers received maximum flexibility to streamline care delivery and allow patients access to care during the PHE. However, on May 11, 2023, the PHE is set to expire and providers must prepare for regulatory compliance without the benefit of the relaxed requirements afforded by the CMS waivers.

Given the need for guidance, CMS has published several provider-specific fact sheets to share important information about the coming changes. Although it is highly recommended that providers and administrators read the fact sheets relevant to their practice areas, the list below contains some of notable changes of which providers and administrators should be aware.

• Regarding Stark Law, the waivers CMS enacted will end, some of which include:

  • The waiver allowing health care providers to pay above or below fair market value for the personal services of a physician (or an immediate family member of a physician), and allowing parties to pay below fair market value to rent equipment or purchase items or services.

  • The waiver allowing hospitals to provide benefits to their medical staff without complying with Stark Law regarding those benefits, such as multiple daily meals, laundry service to launder soiled personal clothing, or childcare services while the physicians were at the hospital and engaging in activities that benefited the hospital and its patients.

  • The waivers allowing providers to offer certain items and services that were solely related to COVID-19 purposes (as defined in the waivers), even when the provision of the items or services would exceed the annual non-monetary compensation cap.

  • The waiver allowing group practices to furnish medically necessary MRIs, CT scans, or clinical laboratory services from locations like mobile vans in parking lots that the group practice rented on a part-time basis.

• Regarding physician care in hospitals, CMS will reinstate the requirement under §482.12(c)(1)-(2) and (4) that Medicare patients in the hospital must be under the care of a physician.

• Regarding information sharing for discharge planning for Home Health Agencies,  CMS will no longer waive the requirements of 42 CFR §484.58(a) to provide detailed information regarding discharge planning, to patients and their caregivers, or the patient’s representative in selecting a post-acute care provider by using and sharing data that includes, but is not limited to, (another) home health agency (“HHA”), skilled nursing facility, inpatient rehabilitation facility, and long-term care hospital quality measures and resource use measures.

• Regarding telemedicine, CMS will reinstate the requirements for in-person, face-to-face visits for evaluations and assessments to the extent that National Coverage Determinations or Local Coverage Determinations require them.

• Regarding training and assessment of aides: CMS will no longer waive the requirement of 42 CFR §418.76(h)(2) for Hospice and 42 CFR §484.80(h)(1)(iii) for HHAs, which require a registered nurse, or in the case of an HHA a registered nurse or other appropriate skilled professional (physical therapist/occupational therapist, speech language pathologist) to make an annual onsite supervisory visit (direct observation) for each aide that provides services on behalf of the agency. CMS is postponing completion of these visits, but all postponed onsite assessments must be completed by these professionals no later than 60 days after the expiration of the PHE.

• Regarding provider and supplier enrollment, CMS will no longer expedite pending and new applications from providers and suppliers received on or after March 1, 2020.

For more information on the coming regulatory changes, contact David B. Bailen, Esq. at dbb@spsk.com or 973-798-4963.

DISCLAIMER: This Alert is designed to keep you aware of recent developments in the law. It is not intended to be legal advice, which can only be given after the attorney understands the facts of a particular matter and the goals of the client.