Compliance Corner

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VACCINATION RULES FOR COVID-19 were clarified in the November 5 Federal Register, which featured CMS’s Interim Final Rule and the Occupational Safety and Health Administration’s (OSHA’s) Emergency Temporary Standards (ETS). These two separate but complementary regulations established COVID-19 vaccination requirements for a large swath of healthcare workers and other privately employed individuals.

With these two new rules, four types of workers fall under some type of vaccine mandate, directly or indirectly, and are required to be fully vaccinated by Jan. 4, 2022: federal workers, federal contractors, healthcare workers, and anyone employed by a company with 100 or more employees.

The two rules share many similarities: They both require a plan to have all covered and eligible employees to be fully vaccinated by Jan. 4, 2022, and they require a plan to track the vaccination progress and allow for religious and medical exemptions. However, there are some differences—the biggest difference being that the CMS rule does not allow for a weekly testing option in lieu of getting vaccinated, whereas the OSHA ETS does offer this option.

Here, we examine the two rules to more clearly explain the similarities and differences, and provide tips and ideas to help you prepare for and comply with the provisions that may apply to you and your facility.

The CMS rule only applies to certain Medicare and Medicaid providers and suppliers that are regulated under specific health and safety standards known as Conditions of Participation (CoPs). The following facilities are subject to CoPs, so their eligible employees are subject to the CMS rule: • Ambulatory surgical centers • Hospices • Psychiatric residential treatment facilities • Programs of all-inclusive care for the elderly • 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) • Long-term-care facilities, including skilled nursing facilities and nursing facilities, generally referred to as nursing homes

• Intermediate care facilities for individuals with intellectual disabilities • Home health agencies • Comprehensive outpatient rehabilitation facilities • Critical access hospitals • Clinics, rehabilitation agencies, and public health agencies as providers of outpatient physical therapy and speech-language pathology services • Community mental health centers • Home infusion therapy suppliers • Rural health clinics/federally qualified health centers • End-stage renal disease facilities. has a contract with a facility, or your practitioners have privileging rights at one of the named facilities, those staff members must be fully vaccinated.

“Fully vaccinated” is defined to mean that you have received the single-dose vaccine (Johnson & Johnson) or both doses of a multidose vaccine (Moderna, Pfizer, etc.) by Jan. 4, 2022. “Fully vaccinated” does not require you to obtain a booster shot.

To ensure compliance with the CMS rule, the above-listed facilities and suppliers must complete some basic requirements: institute a plan or process to vaccinate all eligible employees and staff, institute a process for providing exemptions (religious or medical), provide accommodations for those who are exempt (masks, social distancing, etc.), and create a plan for tracking employee vaccinations.

The ETS released by OSHA is much broader in scope and applies to all U.S. employers that employ 100 or more employees. The OSHA ETS is focused on promoting safety in the workplace and is not limited to any industry or profession. Unlike the CMS rule, the OSHA regulation provides an alternative to vaccination that would allow employees to undergo weekly COVID-19 testing; however, the employer is not required to pay for the testing and the unvaccinated individual must wear appropriate face coverings while at work.

The OSHA ETS requires all eligible employees and those not exempted for religious or medical reasons to be fully vaccinated by Jan. 4, 2022, and the definition of fully vaccinated is the same as discussed previously. The eligible employees, or those that make up the 100 total, are slightly different than described in the CMS rule.

The OSHA 100-employee count is conducted at the company level as a whole and not by an individual location level. So, if you have satellite offices or locations for a single corporate entity, all employees at all locations are to be counted. This includes all part-time employees as well as employees who are teleworking/working from home. However, the OSHA ETS does not apply to employees and workers who do not directly report to a workplace where other individuals such as co-workers, customers, or patients are present; this means that staff who are working from home are still counted in the employee totals, but they are not required to be fully vaccinated by the deadline.

To ensure compliance with the OSHA ETS, those companies that have 100 or more employees must meet the following requirements: develop and implement a policy on vaccination; determine the vaccination status of all employees; support employee vaccinations (via paid time off); implement testing for employees who are not fully vaccinated; require employees to provide notice of a positive COVID test; require face coverings for nonfully-vaccinated employees; provide information to employees about the ETS and vaccines; report work-related COVID fatalities and hospitalizations; and make your records available.

The CMS and OSHA rules are currently being challenged in court and could possibly be altered—but that does not mean you should wait to comply. These rules are effective immediately, so you must accomplish several steps now if your facility falls into the categories described within the rules.

TIP 1 Determine your coverage. Are you required to follow the CMS rule or OHSA’s ETS—or are you not included in either? Also, determine which employees are required to be fully vaccinated.

TIP 2 Determine the vaccination status of employees. You must determine and maintain the vaccination status of all employees and staff. Create a log indicating the vaccination status of each employee (fully vaccinated, partially vaccinated, weekly testing results, etc.). This log does not need to track and record those who have received additional booster shots.

The vaccination requirement in the CMS rule applies to all individuals working at the facilities listed above— whether or not they have direct contact with patients. This includes facility employees, licensed practitioners, students, trainees, volunteers, and those who provide care or treatment to patients or any other services under a contract or other arrangements. It does not include teleworkers, but it does include employees who may work remotely or off site and have interactions with patients.

O&P facilities and professionals are not included in the list of facilities subject to the CMS rule and CoPs, and are therefore not directly subject to mandatory vaccination as a requirement for continued Medicare enrollment. However, they may be indirectly affected. For the above facilities to be compliant with the rule, anyone entering the facility to provide care must be fully vaccinated. So, if your O&P facility

Establish written policy on vaccination

On or before Dec. 6, 2021 Determine vaccine status of employees On or before Dec. 6, 2021 Ensure non-fully-vaccinated employees wear face coverings Provide employees with information about the rules and company policies/procedures On or before Dec. 6, 2021

On or before Dec. 6, 2021

Ensure all employees are fully vaccinated On or before Jan. 4, 2022 Yes Yes Not an option, except for exempted employees Yes

Yes

Ensure non-fully-vaccinated employees are tested weekly Employees receive the single-dose Johnson & Johnson vaccine Employees receive the first dose of the Pfizer-BioNTech vaccine (two doses required) Employees receive the first dose of the Moderna vaccine (two doses required) On or before Jan. 4, 2022

On or before Jan. 4, 2022

On or before Dec. 14, 2021 (second dose will be 21 days later) On or before Dec. 7, 2021 (second dose will be 28 days later) Not an option, except for exempted employees Yes

Yes

Yes

Yes Yes Yes

Yes

Yes

Yes

Yes

Yes

Yes

TIP 3 Review and update your paid-time-off (PTO) requirements/policy. Under the OSHA rule, employers are required to provide employees with up to four hours of PTO to schedule a vaccine appointment, complete the paperwork, receive the vaccine, and travel to and from the vaccination site, but only if the vaccination takes place during normal business hours. You also must provide a fair amount of paid sick leave for an employee to recover from any side effects following vaccination.

TIP 4 Create a policy. Develop a policy to address the new rules. The policy should include information regarding implementation date, to whom the policy applies (covered and eligible employees), deadlines (e.g., deadline for getting vaccinated), and procedures for compliance and enforcement. The main body of your policy should address these elements of the CMS and OSHA rules: • Requirements for

COVID-19 vaccination • Applicable exclusions from the written policy (e.g., medical

contraindications, medical necessity requiring delay in vaccination, or reasonable accommodations for workers with disabilities or sincerely held religious beliefs) • Information on telework, if this is provided as an option (teleworkers under the OSHA ETS do not need to be vaccinated) • Information on determining an employee’s vaccination status • Information on PTO for obtaining the vaccine • Notification of positive

COVID-19 tests • Information on testing options (OSHA ETS only) • Removal of COVID-19-positive employees from the workplace, and guidance on when it is safe to return • Information on how you will share CMS and OSHA rule requirements with employees • Information on masking requirements for unvaccinated employees, if applicable.

It’s not necessary to develop this policy from scratch—OSHA has created a policy template you may use to create a policy tailored to your company. Visit the OSHA website, https://www.osha.gov/coronavirus/ets2. TIP 5 Start communicating with employees. The rules do not specify the frequency by which you must provide information to your employees, or the manner in which you must communicate (memos, letters, emails, meetings, etc.). However, they do specify that you must provide employees with information about the rules, employees’ rights and protections, and the benefits of vaccination.

So, you must inform each employee in plain everyday language about the requirements and the policy you’ve developed to address the requirements (employee vaccination status, PTO for vaccines, notices of negative COVID-19 testing, etc.). You also are required to share information on the safety and benefits of being vaccinated by providing access to CDC’s “Key Things To Know About COVID-19 Vaccines.” Examine the size and geography of your location and determine the best method of relaying vaccination information to your employees.

TIP 6 Create record-keeping and reporting procedures. This involves a three-step process. First, the OSHA rule states that employers must create steps or procedures for employees to report, without delay, a positive COVID-19 test or positive COVID-19 diagnosis to their employer; and positive employees must be removed from the workplace until they meet the CDC’s return-to-work criteria. Ensure your employees understand how and when to notify you if they test positive for COVID-19.

Second, in alignment with Tip 2, a log of employees’ vaccination status must be kept among confidential medical records and must be retained, at a minimum, the length of the ETS. Acceptable proof of vaccination status includes the following: • A record of immunization from a healthcare provider or pharmacy • A copy of the COVID-19 vaccination record card • A copy of medical records documenting the vaccination • A signed and dated employee attestation.

Keep in mind that you are required to make available to an employee, or an employee representative, the aggregate number of fully vaccinated employees at a workplace, along with the total number of employees at that workplace, if requested.

Finally, as with already standing OSHA requirements, you must report to OSHA any work-related COVID-19 fatalities within eight hours of learning about them, and work-related COVID-19 in-patient hospitalizations within 24 hours.

The mandate for federal contractors does not apply directly to O&P facilities; however, it may impact facilities or practitioners indirectly. For example, if you are applying for a future contract with the Department of Veterans Affairs (VA), there may be a stipulation in the contract requiring you to be vaccinated. In addition, just like the CMS rule, if you enter a federal facility to conduct business, you would be required to be vaccinated. So, if you visit a VA hospital to provide care, you must be vaccinated.

Contact AOPA if you have any other questions about the new vaccination rules. Don’t wait to the last minute; begin your compliance now.

Devon Bernard is AOPA’s assistant director of coding and reimbursement services, education, and programming. Reach him at dbernard@AOPAnet.org.

Editor’s Note: Multiple federal lawsuits have resulted in temporary injunctions preventing enforcement of the CMS, OSHA, and Federal Contractor vaccine requirements. AOPA will continue to provide updates as these lawsuits are pursued.

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