CMS requires new standards for COVID-19 vaccine | Troutman Pepper – Community News
Covid-19

CMS requires new standards for COVID-19 vaccine | Troutman Pepper

Who needs to know?
All healthcare providers.

Why it matters
Given the short timeframe required for CMS compliance, facilities must act quickly to ensure they have or can develop and implement these new COVID-19 policies and procedures. In addition, specific documentation standards and related internal processes must be developed and implemented so that the organization can demonstrate compliance in an investigation next year.


On Nov. 5, the Centers for Medicare and Medicaid Services (CMS) issued an Interim Final Rule (IFR), amending the terms of eligibility, terms of coverage, and eligibility requirements. The new IFR requirements will affect 21 different types of providers and suppliers by imposing certain standards for the COVID-19 vaccine. These new requirements apply directly or indirectly to most Medicare and Medicaid certified providers and suppliers, including, but not limited to, hospitals, ambulatory surgical centers, hospices, long-term care facilities, home care facilities, rehabilitation centers, and others (collectively, the ” Services”). [1]

The implementation will be spread over two phases. During Phase 1, 30 days after publication or no later than December 5, the facilities must (1) develop and implement policies and procedures for vaccination against COVID-19 and (2) require staff to administer one dose of the vaccine for a single dose or at least one dose of a primary series vaccine. During Phase 2, 60 days after publication or by January 4, 2022, personnel must have received one dose of the single-dose vaccine or completed all doses required to qualify a primary series vaccine as “fully vaccinated.” ” to be considered. As discussed in more detail below, the staff allowed an exception, or “for whom” [a] COVID-19 vaccination should be temporarily deferred, as recommended by the CDC, due to clinical precautions and considerations.

Below are some key areas that a facility’s COVID-19-related policies and procedures should focus on during the initial 60-day implementation phase.

What does it mean to be fully vaccinated? As discussed above, fully vaccinated means staff must be at least two weeks away from the time they have “completed a primary vaccination course for COVID-19”. This is defined as “the administration of a single dose vaccine, or the administration of all required doses of a multiple dose vaccine.” Interestingly, however, the rule allows staff members who are less than two weeks away from their last dose to provide patient care even after the initial 60-day implementation phase. To provide patient care or treatment, staff should only have a single dose of COVID-19 vaccine or “the first dose of the primary vaccination series for a multi-dose COVID-19 vaccine,” but the facility must have a procedure in place to ensure that staff receive the second dose, if appropriate.

Who is affected? The revised rules apply to employees, licensed practitioners, students, interns, volunteers, contractors, and others who provide patient care, treatment, or other services to a facility and/or its patients. Employees who provide support services or telehealth or telemedicine services only outside the Facility are not affected if they have no contact with patients or staff who have contact with patients.

Are GP practices covered? Physician practices are not directly covered by the IFR as they are not regulated by CMS’s eligibility requirements. However, individual practitioners who have one of the covered Facilities (i.e, a hospital, ASC, hospice, long-term care facility, etc.), or provide services under contract or other arrangement with a covered facility, may find they need to be vaccinated (or apply for a waiver) as a result of their relationship with the facility.

What documentation is required? The IFR requires Facilities to develop and document processes to ensure that all personnel are fully vaccinated (as defined above). Exceptions are made for staff members who are granted exemption or whose vaccination has to be temporarily postponed due to “clinical precautions and considerations” recommended by the GGD.

Specifically, the new rule requires covered facilities to develop policies and procedures designed to implement processes that:

  1. ensure that precautions are taken to help reduce the transition and spread of COVID-19 for personnel who are not fully vaccinated;

  2. Track and document staff’s COVID-19 vaccination status to list if they received CDC-recommended boosters; [2]

  3. Allow employees to apply for an exemption under applicable federal law;

  4. Track and document information provided by employees applying for and receiving a waiver;

  5. Track and document the vaccination status of those for whom COVID-19 vaccination must be temporarily deferred under the CDC recommendations; [3] and

  6. Include emergency plans for employees who are not fully vaccinated.

The IFR also requires that a staff member’s medical waiver documentation include a signed statement from a licensed practitioner practicing within his/her scope (and who is not the person applying for the waiver) that includes:

  1. Information indicating which vaccine is clinically contraindicated and the reasons for such contraindication; and

  2. A recommendation from the authenticating practitioner to release the employee based on the clinical contraindication.

Which exemptions are allowed? In the IFR, CMS recognizes the obligation that facilities have to comply with anti-discrimination and civil rights laws – specifically, the Americans with Disabilities Act (ADA), Section 504 of the Rehabilitation Act (RA) Title VII of the Civil Rights Act of 1964. Discrimination Act, the Genetic Information Non-Discrimination Act and others. To that end, the IFR requires that a facility’s policies and procedures include a process for receiving and evaluating individual requests for waivers from the COVID-19 vaccination mandate for a “disability, medical condition, or genuine religious belief, practice, or adherence.” The IFR also requires facilities to “take additional precautions, … to reduce the transmission and spread of COVID-19, for all personnel not fully vaccinated against COVID-19.”

OSHA’s temporary emergency standard announced on Nov. 5 that employees who are not fully vaccinated (1) must undergo regular COVID-19 testing (once every seven days, along with documentation of the most recent COVID-19 test result) and (2) wear a face covering at work. For more information, see Troutman Pepper’s article, “DOL-OSHA Announces New COVID-19 Vaccine ETS for Private Sector Workers.” However, the IFR does not stop mandating these additional procedures and appears to leave it to the Facility to impose appropriate “precautions”.

What will enforcement look like? Consistent with how CMS is handling other standards, it plans to issue interpretive guidelines and research procedures to address the new COVID-19 vaccine requirements. Once issued, we expect surveyors to pay particular attention to how Facilities have implemented these standards throughout their organization. If cited for non-compliance, facilities may be subject to civil fines, denial of payment for new admissions, or termination of their Medicare/Medicaid provider agreement. “CMS will closely monitor the status of staff immunization coverage, health care provider compliance, and any other potential health and safety risks for patients, recent adults, clients and participants in the PACE program.”

Given the short timeframe required for CMS compliance, facilities must act quickly to ensure they have or can develop and implement these new COVID-19 policies and procedures. In addition, specific documentation standards and related internal processes must be developed and implemented so that the organization can demonstrate compliance in an investigation next year.


[1] The full list of health care providers affected by these changes includes: ambulatory surgical centers, hospices, psychiatric residential treatment facilities, all-inclusive care programs for the elderly, hospitals, long-term care facilities, intermediate care facilities, home care facilities, comprehensive outpatient rehabilitation, intensive care hospitals, clinics, rehabilitation agencies and public health agencies as providers of outpatient physical therapy and speech therapy services, community mental health centers, providers of home infusion therapies, national health clinics/federally qualified health centers, and end-stage renal failure disease facilities.

[2] Acceptable forms of vaccination evidence include (1) CDC COVID-19 Vaccination Card (or a legible photo of the card), (2) documentation of vaccination from a healthcare professional or electronic health record, or (3) state immunization record information system.

[3] These could be those who “have acute illness secondary to COVID-19 and those who have received monoclonal antibodies or convalescent plasma for the treatment of COVID-19…”.