Home Health & Hospice Week

Will lawsuits block the new requirements?

Under a new interim final rule with comment period, you need to have all of your home health agency and hospice workers inoculated with the first dose of COVID-19 vaccine by Dec. 6 — and that’s just part of the burden the new regulation places on agencies’ shoulders.

Reg #1: The Omnibus COVID-19 Health Care Staff Vaccination IFC published in the Nov. 5 Federal Register and released Nov. 4 requires providers, including HHAs and hospices, to vaccinate all workers except those with legitimate exemptions. Agencies must also track and document both the vaccination statuses and exemptions of all workers, says the rule from the Centers for Medicare & Medicaid Services.

Reg #2: The Occupational Safety & Health Administration also issued its Emergency Temporary Standards for protecting workers of large employers from COVID-19. It requires either vaccination or weekly testing for companies with over 100 workers.

“In addressing how the IFR works in conjunction with OSHA ETS requirements, CMS instructs providers first to look to the IFR and CMS guidelines,” advise attorneys Susan Feigin Harris, Kathleen Rubinstein, and Howard Young with law firm Morgan Lewis. “CMS says the IFR takes priority above other federal vaccination requirements for CMS-certified entities,” Feigin, Rubinstein, and Young say in online analysis of the regulations.

The rule instructs affected Medicare- and Medicaid-certified healthcare providers to require that all staff receive their first dose of COVID-19 vaccine by Dec. 6 and the final dose by Jan. 4. Providers must also grant vaccination exemptions under laws such as the Americans with Disabilities Act for medical exemptions and Title VII of the Civil Rights Act of 1964 for religious exemptions.

Home health and hospice agencies are specifically listed in the reg, but it doesn’t apply to private duty agencies and others not certified by Medicare and Medicaid, notes the National Association for Home Care & Hospice.

In addition to requiring vaccinations and exemptions, providers must track and document them, CMS says in the rule. Vaccination can be tracked with COVID vaccination cards, for example.

“In anticipation of state legal challenges or legislative prohibitions on vaccine mandates, CMS asserts that a Covered Facility is required to follow the regulation because, under the Supremacy Clause of the U.S. Constitution, it preempts any state law to the contrary,” point out attorneys Kristin Ahr, Amy Cheng, Giles Schanen Jr., and Phillip Mullinnix with law firm Nelson Mullins in legal analysis.

The mandate covers just about any type of employee or volunteer, except those who are 100 percent remote. But remember, “employees and individuals who have any contact with other staff must be vaccinated, regardless of whether they have contact with patients/residents/participants,” stresses trade group LeadingAge in its rule analysis.

“New hires are also subject to these provisions,” LeadingAge points out. “Newly hired staff must receive at least one dose of vaccine prior to providing care, treatment, or services and must be fully vaccinated ahead of the phase 2 compliance deadline. LeadingAge is seeking clarification about new hires after the phase 2 compliance deadline.”

CMS specifies that workers who have previously had a COVID-19 infection are not exempt, except temporarily when they first contract it and have to wait to receive the vaccine, the Nelson Mullins attorneys highlight.

Unlike the OSHA ETS, there’s no testing option under the CMS rule, legal experts note.

CMS will enforce the requirements via surveys, since they will become part of the Medicare Conditions of Partici­pation, note the Nelson Mullins attorneys.

The rule is already facing legal challenges. Ten states filed suit on Nov. 10, claiming that the federal government has overreached its authority to dictate what happens in their states, reports the New York Times. On Nov. 15, 12 more states filed suit against the CMS rule, the Associated Press reports.

As for the OSHA ETS mandate for large businesses, lawsuits have been filed in multiple jurisdictions and a federal appeals panel has temporarily blocked the rule. In a random drawing, the U.S. 6th Circuit Court of Appeals has been chosen to hear the consolidated challenges to the rule, AP reports. That court is dominated by judges appointed by Republicans, the news outlet notes.

“For now, the pause button has been hit,” observe attorneys Angelo Spinola, William Vail, and Christopher Razo with law firm Polsinelli. “If the ETS survives these legal challenges, the original dates for compliance will likely be pushed back.”

But the Biden-Harris administration appears ready to fight, and providers shouldn’t assume they’ll be off the hook.

Plus: The CMS rule is not tied to the COVID-19 PHE, NAHC points out. That means you could be subject to the vaccination requirement indefinitely.

Keep in mind: The stay on the OSHA ETS rule doesn’t affect OSHA’s Healthcare ETS from this past summer, the CMS rule, nor new Biden administration requirements for federal contractors, note attorneys Dana Stutzman, Drew Howk, and Claire Bailey with Hall Render. “None of these regulatory requirements are stayed by the Fifth Circuit’s ruling on OSHA’s Vaccine ETS,” they emphasize.

Accordingly, providers should start prepping for the Dec. 6 and Jan. 4 deadlines ASAP. “We have work to do,” exclaims Mary Madison, clinical consultant with Briggs Healthcare, in online analysis of the requirement.

Review all relevant materials, including the 73-page final rule at https://www.govinfo.gov/content/pkg/FR-2021-11-05/pdf/2021-23831.pdf and an 11-page Frequently Asked Question set from CMS at www.cms.gov/files/document/cms-omnibus-staff-vax-requirements-2021.pdf, LeadingAge recommends.

Keep an eye out for forthcoming interpretive guidelines promised by CMS as well, NAHC says.

Get Your P&Ps Squared Away Pronto

“In light of the short timeline for compliance with the requirements of the IFC, Providers/Suppliers should immediately begin developing and implementing the policies, procedures, and processes required by the IFC,” urge attorneys Sarah Carlins, Darlene Davis, and Jacqueline Hoffman with law firm K&L Gates in legal analysis.

Developing policies for reviewing and approving or denying exemptions may prove the most burdensome for agencies, warns attorney Robert Markette Jr. with Hall Render in Indianapolis.

One tip: If you have a medical director or other physician, nurse practitioner, etc. on staff, “don’t have them sign the medical exemptions,” Markette tells AAPC. “It’s not a good idea.”

Markette began hearing from providers already fielding exemption requests days after the rule dropped, he reports. One thing to keep in mind: Medicare surveyors will enforce your vaccination compliance, but the Equal Employment Opportunity Commission will enforce medical and religious exemption complaints, he offers. v

Note: The 154-page OSHA ETS interim final rule is at www.govinfo.gov/content/pkg/FR-2021-11-05/pdf/2021-23643.pdf.