Released on Nov 5, 2021

CMS Issues Emergency Regulations Mandating Vaccination Requirements for Health Care Workers

On November 4, the Centers for Medicare and Medicaid Services (CMS) issued emergency regulations requiring health care workers to be fully vaccinated against COVID-19, unless exempt. The rule applies to health care facilities participating in Medicare or Medicaid, including ambulatory surgery centers (ASCs) and hospitals. The rule does not apply to physician offices, although physician offices may be subject to other State or Federal COVID-19 vaccination requirements, such as those issued by the Occupational Safety and Health Administration (OSHA).

CMS has made available a document of frequently asked questions. Your ASGE policy team has compiled a list of key provisions from the rule.

•   The CMS emergency vaccine regulations apply to facilities that participate in Medicare and Medicaid and that are regulated under CMS Conditions for Participation, Conditions for Coverage, or Requirements. For these facilities, which include ASCs, these new regulations take precedence over other vaccine regulations and requirements.

•  Consistent with CDC guidance, CMS defines fully vaccinated if it has been two or more weeks since the individual completed a primary vaccination series for COVID-19. Fully vaccinated means either two doses of Pfizer or Moderna, or one dose of Johnson & Johnson. Neither third doses nor booster doses are required.

•  Staff must receive the first dose, or only dose as applicable, by December 5, 2021.

•  Staff must complete the primary vaccination series by January 4, 2022. Those who complete the primary series for COVID-19 vaccination by January 4 are considered to have met requirements even if they have not yet completed the 14-day waiting period required for full vaccination.

•  Vaccination is required for all staff who interact with other staff, patients, residents, clients, or PACE program participants in any location, beyond those that physically enter facilities, clinics, homes, or other sites of care. Individuals who provide services 100 percent remotely, such as fully remote telehealth or payroll services, are not subject to these vaccination requirements.

•  Vaccine exemptions may include recognized clinical contraindications. Medical exemptions and all documentation supporting a clinical contraindication must be signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice.

•  Staff who cannot be vaccinated or tested because of an ADA disability, medical condition, or sincerely held religious beliefs, practice, or observance may in some circumstances be granted an exemption. Additional resources are provided by the Equal Employment Opportunity Commission. A template for a religious exemption request can be found here.

•  Providers are not required to ensure the vaccination of individuals who infrequently provide ad hoc non-health care services (such as annual elevator inspection), or services that are performed exclusively off site.

•  Providers are required to track and securely document the vaccination status of each staff member, including those for whom there is a temporary delay in vaccination, such as recent receipt of monoclonal antibodies or convalescent plasma. Vaccine exemption requests and outcomes must also be documented. CDC provides a free staff vaccination tracking tool. Facilities must have appropriate policies and procedures developed and implemented by December 5. There are no new data reporting requirements with this regulation.

•  Appropriate places for vaccine documentation include a facility’s immunization record, health information files, or other relevant documents. All medical records, including vaccine documentation, must be kept confidential and stored separately from an employer’s personnel files, pursuant to ADA and the Rehabilitation Act.

•  Examples of acceptable forms of proof of vaccination include: CDC COVID-19 vaccination record card (or a legible photo of the card); Documentation of vaccination from a health care provider or electronic health record; or State immunization information system record. If vaccinated outside of the United Sates, a reasonable equivalent of any of the previous examples would suffice.

•  Some states and localities have established laws that would seem to prevent Medicare- and Medicaid-certified providers and suppliers from complying with the requirements of this rule. This nationwide regulation preempts State and local laws as applied to Medicare- and Medicaid-certified providers and suppliers.

•  For purposes of compliance enforcement, CMS will issue interpretive guidelines, which will include survey procedures. CMS will advise and train state surveyors on how to assess compliance with the new requirements among providers and suppliers.

•  State survey agencies will conduct compliance in two ways: recertification surveys and complaint surveys. Accrediting organizations will also assess for compliance.

•  Surveyors will check to see if a facility has met three basic requirements: 1) having a process or plan for vaccinating all eligible staff; 2) having a process or plan for providing exemptions and accommodations (e.g., testing, physical distancing, source control) for those who are exempt; 3) having a process or plan for tracking and documenting staff vaccinations.

•  Providers and suppliers that are cited for noncompliance may be subject to enforcement remedies imposed by CMS depending on the level of noncompliance and the remedies available under federal law. As stated in the Agency’s FAQ, for hospitals and another acute providers, such as ASCs, the remedy for non-compliance is termination; however, CMS states its goal is to bring health care facilities into compliance and that termination would generally occur only after providing a facility with an opportunity to make corrections and come into compliance.

The next CMS webinar on this topic is November 10 at 2:30pm CT.


About Gastrointestinal Endoscopy
Gastrointestinal endoscopic procedures allow the gastroenterologist to visually inspect the upper gastrointestinal tract (esophagus, stomach and duodenum) and the lower bowel (colon and rectum) through an endoscope, a thin, flexible device with a lighted end and a powerful lens system. Endoscopy has been a major advance in the treatment of gastrointestinal diseases. For example, the use of endoscopes allows the detection of ulcers, cancers, polyps and sites of internal bleeding. Through endoscopy, tissue samples (biopsies) may be obtained, areas of blockage can be opened and active bleeding can be stopped. Polyps in the colon can be removed, which has been shown to prevent colon cancer.

About the American Society for Gastrointestinal Endoscopy
Since its founding in 1941, the American Society for Gastrointestinal Endoscopy (ASGE) has been dedicated to advancing patient care and digestive health by promoting excellence and innovation in gastrointestinal endoscopy. ASGE, with almost 15,000 members worldwide, promotes the highest standards for endoscopic training and practice, fosters endoscopic research, recognizes distinguished contributions to endoscopy, and is the foremost resource for endoscopic education. Visit Asge.org and ValueOfColonoscopy.org for more information and to find a qualified doctor in your area.

 

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Media Contact

Andrea Lee
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ALee@asge.org