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CMS Issues Guidance on Covid-19 Vaccination Requirements for Most Medicare- and Medicaid-Certified Providers

The Centers for Medicare & Medicaid Services (CMS) on Dec. 29 issued guidance regarding the Interim Final Rule (IFR) regarding Covid-19 vaccination requirements for healthcare staff that the agency published in early November.

In the Dec, 29 memo, CMS specified that this guidance does not apply to the following states that are still subject to preliminary injunctions that federal courts issued to block implementation of the IFR in those states: 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, Texas, Utah, West Virginia, and Wyoming.

The new CMS guidance delineates the following deadlines and clarifications for requirements that most Medicare- and Medicaid-certified providers must meet in all other states:

Within 30 days after issuance of the guidance, healthcare facilities must:

  • Have policies and procedures developed and implemented to ensure all facility staff are vaccinated; and
  • 100% of staff have received at least one dose of Covid-19 vaccine, or have requested an exemption due to a disability or sincerely held religious beliefs, or must wait to receive the vaccine as the Centers for Disease Control and Prevention (CDC) recommends.
  • Facilities that fail to meet this requirement will receive notice of non-compliance, but those that are above 80% and have a plan to achieve 100% staff vaccination within 60 days will not be subject to additional enforcement action.

Within 60 days after the guidance has been issued, healthcare facilities must:

  • Have policies and procedures developed and implemented to ensure all facility staff are vaccinated; and
  • 100% of staff have received completed vaccine series or been granted an exemption due to a disability, or sincerely held religious beliefs, or must wait to receive the vaccine as the CDC recommends.
  • Facilities that fail to meet this requirement will receive notice of their non-compliance, but those that are above 90% and have a plan to achieve 100% staff vaccination within 30 days will not be subject to additional enforcement action.

Within 90 days of issuance of the guidance, facilities failing to maintain compliance with the 100% standard may be subject to enforcement action.

CMS also issued specific guidance for each healthcare facility type subject to the IFR, including hospitals and psychiatric residential treatment facilities (PRTFs). The guidance for hospitals and PRTFs appears to be the same. These more specific guidance documents note that “the requirements described above do not include the 14-day waiting period as identified by CDC for full vaccination. Rather, these requirements are considered met with the completed vaccine series (i.e., one dose of a single dose vaccine, or final dose of a multi-dose vaccine series).”

This guidance specifies that hospitals and PRTFs “must have a process for ensuring all staff have received at least a single-dose, or the first dose of a multi-dose Covid-19 vaccine series prior to providing any care, treatment, or other services for the facility and/or its patients.”

Hospitals and PRTFs “must also ensure those staff who are not yet fully vaccinated . . . adhere to additional precautions that are intended to mitigate the spread of Covid-19.” The guidance suggests a variety of actions or job modifications a facility can implement, including reassigning staff to remote work, mandatory routine Covid-19 testing in accordance with Occupational Safety and Health Administration (OSHA) and CDC guidelines, and requiring staff to wear N95 or higher-level respirators. CMS suggests similar actions for unvaccinated staff who are exempt from the vaccination requirements.

The guidance for hospitals and PRTFs clarifies that “[s]taff who exclusively provide telehealth or telemedicine services outside of the hospital setting” and “[s]taff who provide support services for the hospital that are preformed exclusively outside of the hospital setting” are exempt from the vaccination requirements. The guidance also notes, however, “that these individuals may be subject to other federal requirements for Covid-19 vaccination.”

In addition, the guidance notes that hospitals and PRTFs are not required to ensure that “one-off” vendors, volunteers, and professionals that provide infrequent, ad hoc, non-healthcare services (such as annual elevator inspections) are vaccinated.

Hospitals and PRTFs must track and securely document the following information:

  • Each staff member’s (including contractors, volunteers, and students) vaccination status including specific vaccine, date of each dose, and date of next scheduled dose as well as each staff’s role, assigned work area, and how they interact with patients;
  • Staff who have obtained any booster doses (including specific vaccine and date);
  • Staff granted an exemption (including type of exemption and supporting documentation including documentation signed and dated by a licensed practitioner for medical exemptions);
  • Staff for whom vaccination must be temporarily delayed (including date when staff can safely be vaccinated); and
  • Staff who telework full-time.

The CMS guidance also recommends that hospitals and PRTFs refer to the following CDC informational document when assessing requests for medical exemptions: Summary Document for Interim Clinical Considerations for Use of Covid-19 Vaccines Currently Authorized in the United States.

Regarding religious exemptions, the CMS guidance directs hospitals and PRTFs to the Equal Employment Opportunity Commission Compliance Manual on Religious Discrimination for information on evaluating and responding to such requests.

The guidance also discusses contingency plans that hospitals and PRTFs must have in place for staff who do not comply with these vaccination requirements, including those who qualify for an exemption. These plans can include actively seeking replacement staff or temporary vaccinated staff until permanent vaccinated replacements can be hired.

Surveyors will begin evaluating for compliance 30 days after this guidance was issued during full surveys for recertification or reaccreditation, federal initial surveys, or complaint surveys.

This guidance includes detailed instructions for surveyors, including levels of deficiency that may be assigned based on levels of staff vaccination and other factors including whether policies and procedures regarding staff Covid-19 vaccination have been developed and implemented by a facility.  In addition, the guidance specifies that surveyors may lower a citation level and/or enforcement action if they identify that prior to the survey that:

  • A hospital or PRTF “has no or has limited access to vaccine, and the hospital [or PRTF] has documented attempts to obtain vaccine access (e.g., contact with health departments and pharmacies)”; or
  • A hospital or PRTF “provides evidence that they have taken aggressive steps to have all staff vaccinated, such as advertising for new staff, hosting vaccine clinics, etc.”
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SAMHSA Extends Take-Home Methadone Flexibilities to OTPS for One Year

The Substance Abuse and Mental Health Services Administration (SAMHSA) on Thursday said it will extend for one year the methadone take-home flexibilities it provided to opioid treatment programs (OTPs) at the start of the Covid-19 pandemic in March 2020 and is “considering mechanisms to make this flexibility permanent.”

This flexibility has allowed OTPs to dispense 28 days of take-home methadone doses for stable patients and up to 14 days of take-home methadone medication to less stable patients, based on provider assessments.

SAMHSA’s announcement said it is extending the flexibilities for a year “effective upon the eventual expiration of the Covid-19 Public Health Emergency.”

Click here to read SAMHSA’s announcement.

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CMS to Require COVID-19 Vaccinations for Medicare and Medicaid Providers

  • CMS is requiring that all staff of certain providers and suppliers participating in the Medicare or Medicaid programs receive the COVID-19 vaccine.
  • The IFR does not allow for weekly testing in lieu of vaccination.
  • The agency expressly preserves an employer’s right to require its employees to be fully vaccinated, regardless of the exemptions provided by the IFC.

Today, the Centers for Medicare and Medicaid Services (CMS) issued an interim final rule with comment (IFC), establishing COVID-19 vaccination requirements for staff at specified Medicare- and Medicaid-certified providers and suppliers. The IFC, entitled, “Medicare and Medicaid Programs: Omnibus COVID-19 Health Care Staff Vaccination” (rule; press release; FAQ) stipulates that all staff members, including those who perform their duties outside of a formal clinical setting, of certain providers and suppliers participating in the Medicare and Medicaid programs must be fully vaccinated against COVID-19 unless exempt. The IFC provides that individuals who provide services 100 percent remotely are not subject to the vaccination requirements; however, staff that primarily provide services remotely via telework who occasionally encounter fellow staff are still bound by the IFC’s provisions.

  • Background: On September 9, 2021 President Biden issued an executive order  (EO) entitled “Path out of the Pandemic,” a multifaceted COVID-19 response plan  that seeks to boost vaccinations and testing amid the surge in the delta variant. The President’s new plan focuses on six core components, including: (1) “Vaccinating the Unvaccinated;” (2) “Further Protection for the Vaccinated;” (3) “Keeping Schools Safely Open;” (4) “Increased Testing and Requiring Masking;” (5)  “Protecting Our Economic Recovery”; and (6) “Improving Care for Those with COVID-19.” To further the mission of this EO, CMS and the Occupational Health Services Administration (OSHA) issued regulations requiring certain individuals in the workforce to be vaccinated against COVID-19. In today’s IFC, CMS indicates that providers and suppliers may be covered by both the OSHA rules and the CMS IFC.

CMS is providing two implementation phases for the IFC in order to ensure efficiency in carrying out these requirements — effective 30 and 60 days after publication of this IFC in the Federal Register for Phases 1 and 2, respectively. The IFC notes that non-compliant facilities may be subject to civil money penalties, denial of payment for new admissions, or termination of their Medicare and Medicaid provider agreement. The agency also stated that it intends to retain these provisions beyond the conclusion of the public health emergency (PHE) as relevant, adding that it may deem these provisions permanent for facilities. To this end, CMS highlighted that this rulemaking is not associated with or tied to the PHE declarations, nor is there a sunset clause.

  • What’s Next? The final rule is expected to be published in the Federal Register on November 5, 2021, with an expected effective date of January 4, 2022. Comments to the IFC must be received no later than 60 days after the publication of the IFC in the Federal Register. While legal challenges to these guidelines are expected, CMS has already notably indicated in today’s IFC that, to the extent a court may enjoin any part of the rule, it intends that all other provisions or parts of provisions are to remain in effect.

Key policy items outlined in the IFC include:

  • Applicable Entities — The IFC provides that Medicare- and Medicaid-certified providers and suppliers must require that all applicable staff are fully vaccinated for COVID-19. Specifically, the entities subject to these requirements include:
    1. ambulatory surgical centers (ASCs);
    2. hospices;
    3. psychiatric residential treatment facilities (PRTFs);
    4. programs of all-inclusive care for the elderly (PACE);
    5. hospitals, including acute care hospitals, psychiatric hospitals, long term care hospitals, children’s hospitals, hospital swing beds, transplant centers, cancer hospitals, and rehabilitation hospitals;
    6. long term care (LTC) facilities, including skilled nursing facilities (SNFs) and nursing facilities (NFs);
    7. intermediate care facilities for individuals with intellectual disabilities (ICFs-IID);
    8. home health agencies (HHAs);
    9. comprehensive outpatient rehabilitation facilities (CORFs);
    10. critical access hospitals (CAHs);
    11. clinics, rehabilitation agencies, and public health agencies as providers of outpatient physical therapy and speech-language pathology services;
    12. community mental health centers (CMHCs);
    13. home infusion therapy (HIT) suppliers;
    14. rural health clinics (RHCs)/federally qualified health centers (FQHCs); and
    15. end-stage renal disease (ESRD) facilities.
  • In the IFC, CMS refers to the above facilities as residential congregate-care facilities, acute care settings, outpatient clinical care and services, and home-based care, generally. Notably, the requirements outlined in the IFC do not apply to assisted living facilities, group homes, or physician’s offices because they are not regulated by CMS health and safety standards.
  • Applicable Staff — CMS is requiring that all staff, regardless of patient contact or clinical responsibility, be fully vaccinated against COVID-19. The IFC stipulates that facility employees; licensed practitioners; students, trainees, and volunteers; and individuals who provide care, treatment, or other services for the facility and/or its patients, under contract or other arrangement, are subject to this requirement. The agency notes that staff who perform their duties outside of a formal clinical setting — such as home health, home infusion therapy, hospice, PACE programs, and therapy staff — are not precluded from the rule. Further, CMS asserts that individuals who provide services 100 percent remotely — including fully remote telehealth or payroll services — are not subject to the vaccination requirements. However, staff that primarily provide services remotely via telework who occasionally encounter fellow staff are still bound by the rulemaking.
  • Definition of “Fully Vaccinated” — Under the IFC, an individual is considered to be “fully vaccinated” if it has been two weeks or more since such individual completed a primary vaccination series defined as a single-dose or all doses of a multi-dose vaccine approved by the Food and Drug Administration (FDA). Importantly, individuals who receive vaccines listed by the World Health Organization (WHO) for emergency use but have not been approved or authorized by the FDA will also be counted as fully vaccinated for the purposes of the rulemaking. Additionally, individuals are not required to receive a booster or third dose of a vaccine in order to be considered fully vaccinated. However, providers and suppliers covered by the IFC must have a process for tracking and securely documenting the vaccination status of individuals who have obtained any booster.
  • Exceptions — CMS is requiring that applicable providers and suppliers establish and implement a process to allow staff to request an exemption from COVID-19 vaccination requirements based on applicable Federal law. The agency cites certain allergies; recognized medical conditions; or religious beliefs, observances, or practices as possible grounds for exemption. Providers and suppliers covered by the IFC are also required to document exemption requests from the vaccine requirements as well as the outcomes of those requests. Further, the agency is requiring that all applicable providers and suppliers establish a process to ensure the implementation of additional precautions to mitigate the transmission of COVID-19 for all staff who are not fully vaccinated. Notably, CMS expressly preserves an employer’s right to require that employees be fully vaccinated, regardless of the exemptions provided by the IFC.
  • Implementation — CMS is providing two implementation phases for the IFC in order to ensure efficiency in carrying out these requirements.
    • Phase 1. This phase includes a large majority of provisions in the IFC, including requirements that: (1) all staff have received at least the first dose of the COVID-19 vaccine, or a single dose COVID-19 vaccine, or have requested and/or been granted a lawful exemption to the requirement and (2) facilities have developed and implemented the aforementioned policies and procedures. Phase 1 is effective 30 days after the publication of this IFC in the Federal Register.
    • Phase 2. This phase requires that all applicable staff are fully vaccinated for COVID-19, unless granted an exception, which must be fully approved at this phase. Staff who have completed a primary vaccination series by this date are considered to have met these requirements, even if they have yet to complete the 14-day waiting period required for full vaccination. Phase 2 is effective 60 days after the publication of this IFC in the Federal Register.
  • Enforcement — CMS plans to issue interpretive guidelines, which include state survey procedures, to aid in assessing compliance with the new requirements among providers and suppliers following the publication of this IFC. The agency provides that non-compliant facilities may be subject to civil money penalties, denial of payment for new admissions, or termination of their Medicare and Medicaid provider agreement.
  • Other Provisions — This rule does not provide any prevention and control requirements for PRTFs, RHCs/FQHCs, and HIT suppliers. However, it does require that these entities create procedures in accordance with nationally recognized guidelines to limit the spread of COVID-19. Further, this IFC requires that providers and suppliers retain proper documentation of the vaccination status of each staff member, such as: (1) CDC COVID-19 vaccination card or legible photo of the card; (2) documentation of vaccination from a health care provider or electronic health record; or (3) a state immunization information system record.
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