January 27, 2022 marks the deadline for Connecticut health facilities to have policies and procedures in place to satisfy federal Center for Medicare and Medicaid Services (“CMS”) regulations mandating vaccines of their non-exempted staff.  In addition, the regulations require that 100% of facility staff must have received at least one vaccine dose, have a pending exemption or otherwise must be identified as needing a delay in vaccination. The regulations issued last year as an Interim Final Rule were the subject of a January 13 United States Supreme Court decision staying an injunction that had delayed implementation of the regulations in 24 states, but not Connecticut.

On the state vaccine mandate front, Governor Lamont is expected to soon specify which of about 11 executive orders issued to date he would like to keep in force, rather than have them expire after February 15, the current date of expiration of his COVID-19 emergency powers. The Governor’s executive orders have included  Executive Order 13F which mandates vaccines, for staff and volunteers not otherwise exempted at “long term care facilities.” Under Connecticut law affected facilities include assisted living facilities, nursing homes, residential care homes, intermediate care facilities for persons with intellectual disabilities, managed residential communities, and chronic disease hospitals.

The CMS vaccine mandate covers Medicare and Medicaid certified suppliers and health care facilities included in the following list if subject to the federal “conditions of participation” found at Title 42 of the Code of Federal Regulation. (The section numbers associated with each category of provider identify the conditions of participation applicable to facilities which are Medicare and Medicaid certified providers) –

• 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)

Since the release of its Interim Final Rule on the vaccine mandate on November 5, 2021, CMS has issues several guidance documents dated December 28, 2021, January 14, 2021 and January 20, 2021. The January 14 and January 20 guidance does not apply to Connecticut, Massachusetts, New York or the twenty-two other states that were not subject to the injunction addressed by the Supreme Court, except that both indicate that states not identified in them are “expected to continue under the time frames and parameters” identified in the December 28 guidance. The January 14 guidance applies to Alabama, Alaska, Arizona, Arkansas, Georgia, Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Montana, Nebraska, New Hampshire, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Utah, West Virginia and Wyoming. The January 20 guidance applies solely to Texas.

The December 28 guidance which applies to the designated Connecticut providers, and the designated providers in the other states covered by the guidance provides that by the January 27 deadline covered facilities are required to demonstrate:

• Policies and procedures are developed and implemented for ensuring all facility staff, regardless of clinical responsibility or patient or resident contact are vaccinated for COVID-19; and

• 100% of staff have received at least one dose of COVID-19 vaccine, or have a pending request for, or have been granted qualifying exemption, or identified as having a temporary delay as recommended by the CDC, the facility is compliant under the rule;

Facilities that fail to meet the 100% standard will receive notice of their non-compliance from CMS.  A facility that is above 80% and has a plan to achieve a 100% staff vaccination rate within 60 days would not be subject to additional enforcement action. Facilities that do not meet these parameters could be subject to additional enforcement actions (e.g., plans of correction, civil monetary penalties, denial of payment, termination, etc.) depending on the severity of the deficiency and the type of facility.

The guidance notes that nursing homes, home health agencies and hospice providers could incur civil monetary penalties, payment denials, and - “as a final measure” – termination of participation from the Medicare and Medicaid programs for non-compliance. The sole enforcement remedy for non-compliance by hospitals, and certain other acute and continuing care providers is termination.  Compliance with the balance of the Interim Final Rule by those subject to the December 28 guidance must be demonstrated by February 28.

CMS surveyors are expected to begin surveying for compliance in Connecticut and the other December 28 guidance states on January 27.

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