CMS, OSHA issue vaccine mandates that may impact staff shortages

by A.J. Plunkett (aplunkett@decisionhealth.com)

Start evaluating staffing levels and develop a plan for educating your workforce on new CMS and OSHA worker COVID-19 vaccine mandates that could impact staffing shortages at hospitals and other health facilities.

Both agencies issued emergency regulations on November 4 calling for workforce vaccines. Both are scheduled to be published in the Federal Register on November 5.

In general, for healthcare facilities receiving Medicare or Medicaid funds, CMS is requiring that all eligible staff must have at least one dose of vaccine by December 5 and be fully vaccinated by January 5, 2022.

The CMS regulation does allow staff to seek exemptions for religious beliefs or recognized medical conditions.

The mandate will be enforced by CMS state surveyors as well as accrediting organizations. However, hospitals and other facilities found in non-compliance will be given a chance to become compliant before monetary penalties are applied, according to information released by CMS.

CMS noted that its interim regulation is designed to work in concert with OSHA’s emergency temporary standard on vaccines and testing for workers who are not vaccinated. CMS also noted in an FAQ that “it is possible that entities not covered by this rule may still be subject to the other state or federal COVID-19 vaccination requirements, such as those being issued by the Occupational Safety and Health Administration (OSHA).”

Mandates may impact worker shortages

The vaccine mandates could impact hospitals and other facilities that are already facing nurse and other staff shortages. Vendors and other contractors will also be affected, said Jennifer Cowel, RN, MHSA, CEO of Patton Healthcare Consulting and a former Joint Commission executive and nurse surveyor.

Hospitals will have to look at current staffing models and evaluate “whether there may be temporary and/or long-term staffing shortages made worse by this ruling,” said Cowel.

“There may need to be creative use of existing licensed staff who occupy a non-patient care role now to cover some shortages,” she said, adding that that will require training, ensuring competencies and oversight. “The hospitals may have to look at using non-RNs to extend care—for example, bringing LPNs into the care team in a safe and compliant way.”

Other potential impacts and recommendations, according to Cowel:

  • “The Vendormate and similar software programs will need to be managed more carefully to ensure the vendors are fully vaccinated and there is appropriate documented evidence.
  • “The contract approval process, and quality oversight of clinical contracts, may need to include a new provision regarding vaccines. The oversight of the contract, which is now annual, should reflect this new requirement.
  • “Human resources and staffing departments will have to request evidence of vaccine for new staff, existing staff, vendors, contractors, volunteers, medical staff, etc.
  • “Employee health, infection prevention, and medical staff will need to creatively work together to coax staff to get vaccinated. There are lessons learned throughout the country both for COVID rollout and flu vaccine compliance that can be mimicked to be as successful as possible."

Remember also that there will need to be a secure and inclusive method to document vaccine status for all classes of employees, vendors, contractors, volunteers, and medical staff, said Cowel.

CMS will enforce mandate

In a news release, CMS warned that it will be surveying to this new regulation, and will work with facilities who have difficulty meeting the requirements. But it is also serious about compliance.

“CMS will ensure compliance with these requirements through established survey and enforcement processes.  If a provider or supplier does not meet the requirements, it will be cited by a surveyor as being non-compliant and have an opportunity to return to compliance before additional actions occur,” according to the information.

“CMS’s goal is to bring health care providers into compliance. However, the Agency will not hesitate to use its full enforcement authority to protect the health and safety of patients,” said CMS.

The agency also issued an 11-page FAQ with some commonly anticipated questions. Here are some of the highlights for hospital compliance.

FAQ excerpts

Q: When does this take effect?

A: The emergency regulation is effective as of November 5, 2021.

Q: Is this a facility-specific or individual-level requirement?

A: The staff vaccination requirements apply to Medicare and Medicaid-certified provider and supplier types (collectively, “facilities”) that are regulated under the Medicare health and safety standards known as Conditions of Participation (CoPs), Conditions for Coverage (CfCs), or Requirements. Facilities are required to have a process or policy in place ensuring that all applicable staff are vaccinated against COVID-19.

Q: Which staff are covered under this requirement?

A. This vaccination requirement applies to eligible staff working at a facility that participates in the Medicare and Medicaid programs, regardless of clinical responsibility or patient contact. The requirement includes all current staff as well as any new staff who provide any care, treatment, or other services for the facility and/or its patients. This includes facility employees, licensed practitioners, students, trainees, and volunteers. Additionally, this also includes individuals who provide care, treatment, or other services for the facility and/or its patients under contract or other arrangements.

Q: Does this requirement apply to full time teleworkers?

A: No. Individuals who provide services 100 percent remotely and who do not have any direct contact with patients and other staff, such as fully remote telehealth or payroll services, are not subject to the vaccination requirements outlined in this regulation.

Q: How quickly must staff be vaccinated in order for the facility to remain compliant with the regulation?

A: The regulation requires health care providers to establish a process or policy to fulfill the staff vaccination requirements over two phases. For Phase 1, within 30 days after the regulation is published, staff at all health care facilities included within the regulation must have received, at a minimum, the first dose of a primary series or a single dose COVID-19 vaccine prior to staff providing any care, treatment, or other services for the facility and/or its patients. For Phase 2, within 60 days after the regulation is published, staff at all health care provider and supplier types included in the regulation must complete the primary vaccination series (except for those who have been granted exemptions from the COVID-19 vaccine or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by CDC).

Q: How will this new requirement be enforced on facilities?

A: CMS works directly with the State Survey Agencies to regularly review compliance with Medicare/Medicaid regulations across multiple health care settings. CMS expects state survey agencies to conduct onsite compliance reviews of these requirements in two ways:

  • State survey agencies would assess all facilities for these requirements during the standard recertification survey.
  • State survey agencies would assess vaccination status of staff on all complaint surveys.

While onsite, surveyors will review the facility’s COVID-19 vaccination policies and procedures, the number of resident and staff COVID-19 cases over the last 4 weeks, and a list of all staff and their vaccination status. This information, in addition to interviews and observations, will be used to determine the compliance of the provider or supplier with these requirements.

Additionally, Accrediting Organizations will be required to update their survey processes to assess facilities they accredit for compliance with vaccination regulations.

Q: How do the penalties work/are providers immediately denied payment?

A: Medicare and Medicaid-certified facilities are expected to comply with all regulatory requirements, and CMS has a variety of established enforcement remedies. For nursing homes, home health agencies, and hospice (beginning in 2022), this includes civil monetary penalties, denial of payment, and even termination from the Medicare and Medicaid program as a final measure. The remedy for non-compliance among hospitals and certain other acute and continuing care providers is termination; however, CMS’s goal is to bring health care facilities into compliance. Termination would generally occur only after providing a facility with an opportunity to make corrections and come into compliance.

Q. What opportunities are available to return to compliance for hospitals and other acute and continuing care providers?

A. CMS surveyors cite hospitals and other facilities based on the severity of deficiency, classified among three levels, from most to least severe: “Immediate Jeopardy”, “Condition”, and “Standard.” In all cases, health care facilities have an opportunity to return to compliance before termination.

  • “Immediate Jeopardy” citations indicate a serious scope of non-compliance, failure of the provider to address deficiencies, and close interaction with patients of unvaccinated staff. Termination of the provider type will occur within 23-days following the citation if not immediately addressed.
  • “Condition” level citations indicate substantial non-compliance that needs to be addressed to avoid termination.
  • “Standard” level citations indicate minor non-compliance where (with respect to this rule) almost all staff are vaccinated, the provider has a reasonable policy in place to educate staff on the vaccinations, and the provider has procedures for tracking and monitoring vaccination rates. CMS generally allows for continued operation subject to the facility’s agreement to a CMS-approved plan of correction.

Q: Is CMS planning to use the new COVID-19 Vaccination Coverage among Health Care Personnel (HCP) quality measure to monitor compliance?

A: No. Providers participating in the Inpatient, PPS-Exempt Cancer Hospital, Long Term Care Hospital, Inpatient Psychiatric, and Inpatient Rehabilitation Quality Reporting Programs are expected to report on the new COVID-19 Vaccination Coverage among Health Care Personnel quality measure from October 1, 2021 to December 31, 2021 as established in the various Fiscal Year 2022 payment rules. While this quality measure will provide valuable insight into the number of staff vaccinated over the course of a three-month period, CMS will continue to ensure compliance with the new staff vaccination requirement through the established survey process. As data become available, CMS will continue to evaluate opportunities to inform the survey process.

Q: Will my feedback be considered?

A: Yes, stakeholders have 60 days to submit formal comment on the emergency regulation. It is important to note that since this is an emergency regulation, the requirements will go into effect immediately and before any additional response is provided on the comments by CMS. The comment period officially closes on January 4, 2022. At that point, CMS will consider and respond to comments as a part of potential future rulemaking, if needed.

You can find the full 11-page FAQ here:

You can find the CMS interim final rule here:

The OSHA information on vaccines and testing can be found here:

 

 

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Accreditation, CMS, COVID-19, OSHA