CMS has released an interim final rule with comment period (IFC) that establishes COVID-19 vaccination requirements for staff at the included Medicare- and Medicaid-certified providers and suppliers, but DME suppliers are not listed among them.
The rule will become live on the Federal Register on Nov. 5, but a draft is available as a PDF. Both are available by clicking here.
The IFC will be open for comments for 60 days.
Specifically, the rule requires all eligible staff to receive the first dose of a two-dose COVID-19 vaccine or a one-dose COVID-19 vaccine prior to providing any care, treatment, or services by Dec. 5. All eligible staff must receive the necessary shots to be fully vaccinated (either two doses of Pfizer or Moderna or one dose of Johnson & Johnson) by Jan. 4, 2022.
The IFC impacts 21 types of providers and suppliers, which CMS listed in the numerical order of the relevant CFR sections being revised in the rule:
- Ambulatory Surgical Centers (ASCs) (§ 416.51)
- Hospices (§ 418.60)
- Psychiatric residential treatment facilities (PRTFs) (§ 441.151)
- Programs of All-Inclusive Care for the Elderly (PACE) (§ 460.74)
- Hospitals (acute care hospitals, psychiatric hospitals, hospital swing beds, long term care hospitals, children’s hospitals, transplant centers, cancer hospitals, and rehabilitation hospitals/inpatient rehabilitation facilities) (§ 482.42)
- Long Term Care (LTC) Facilities, including Skilled Nursing Facilities (SNFs) and Nursing Facilities (NFs), generally referred to as nursing homes (§ 483.80)
- Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs-IID) (§ 483.430)
- Home Health Agencies (HHAs) (§ 484.70)
- Comprehensive Outpatient Rehabilitation Facilities (CORFs) (§§ 485.58 and 485.70)
- Critical Access Hospitals (CAHs) (§ 485.640)
- Clinics, rehabilitation agencies, and public health agencies as providers of outpatient physical therapy and speech-language pathology services (§ 485.725)
- Community Mental Health Centers (CMHCs) (§ 485.904)
- Home Infusion Therapy (HIT) suppliers (§ 486.525)
- Rural Health Clinics (RHCs)/Federally Qualified Health Centers (FQHCs) (§ 491.8)
- End-Stage Renal Disease (ESRD) Facilities (§ 494.30)
Mercifully, HME/DME providers were not listed. For an industry facing mounting operating costs and staffing challenges, the news was welcome.
“My original thought after reading through the rule was of shock, for we all expected that DMEs were going to be a part of it,” said Rose Schafhauser, executive director of the Midwest Association for Medical Equipment Services & Supplies (MAMES). “However, some staff of DMEs whose job requirements include entering the facilities or have contracts with those included will be impacted.”
While the industry seems to have dodged the CMS requirement, some providers might be subject to a requirement from Occupational Safety and Health Administration (OSHA). An OSHA emergency temporary standard (ETS) could impact DME suppliers, manufacturers, distributors and other industry stakeholders with 100 or more employees, according to Tom Ryan, president and CEO of the American Association for Homecare.
“We are still reviewing the CMS rule, as well as the new OSHA regulations impacting companies with more than 100 employees,” Ryan said. “Given the market realities and other challenges suppliers are facing, CMS’ apparent decision to leave DME off the list of healthcare provider types subject to vaccine mandates is a positive development for a large segment of our industry.
“The DME community has done exceptional work serving patients directly and helping reduce the stresses on hospitals and clinicians during the most challenging periods under this pandemic,” he added. “I’m confident suppliers and other stakeholders in our industry will continue to make smart decisions on how to best protect their employees and the patients and caregivers they serve.”
