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Vaccine Mandate Leaves Health-Care Providers Lamenting Omissions (1)

Nov. 4, 2021, 6:57 PMUpdated: Nov. 4, 2021, 9:07 PM

The health-care community was digesting a sweeping vaccine mandate Thursday, praising its aim but bemoaning notable omissions in the directive that requires 17 million workers to be vaccinated against Covid-19 by Jan. 4.

Most of the nursing home industry’s recommendations for the new rule didn’t materialize. Most importantly, the mandate doesn’t allow unvaccinated workers to be regularly tested in order to remain on the job.

In addition, the interim final rule (RIN 0938-AU75) from the Centers for Medicare & Medicaid Services could also allow some workers in the home health industry who don’t want the jab to seek employment at other agencies that aren’t subject to the mandate. Some 500,000 workers in California alone could be exempt from the vaccine requirement, said William Dombi, president of the National Association for Home Care & Hospice.

The health worker mandate applies to workers at a broad range of facilities, including “hospitals, ambulatory surgery centers, dialysis facilities, home health agencies, and long-term care facilities,” according to the White House.

The CMS rule is distinct from another mandate issued, also on Thursday, by the Occupational Safety and Health Administration. The OSHA rule requires employees at companies with more than 100 employees be vaccinated or undergo at least weekly testing. However, it does not apply to workplaces affected by the health worker mandate, the White House said.

Providers will have 60 days to submit formal comment on the emergency regulation from the CMS, but most health-care organizations have supported the goal of the mandate as necessary to ensure the safety of patients and those who care for them.

“We support the Biden administration’s vaccination goals, including for health care workers as they lead our nation’s response to COVID-19. We have supported our members’ efforts to require vaccination for their employees, and we have asked that they commit to promoting equity in vaccine access,” Bruce Siegel, president of America’s Essential Hospitals, said in a statement. America’s Essential Hospitals represents facilities that serve mainly low-income and Medicaid patients.

No Testing Option for Health Workers

Still the vaccine directive did not arrive without controversy. In an August letter to the Department of Health and Human Services, the American Health Care Association and National Center for Assisted Living called on the department to finance daily testing for unvaccinated nursing home staff in order to avert possible labor shortages resulting from the new rule.

If half of unvaccinated nursing home staff quit because of the mandate, it “would be devastating to care,” the letter said. Multiple facilities have expressed “grave concerns about their ability to care for their residents if this mandate is implemented in a way that drives away their staff,” the AHCA letter said.

The interim final rule for health-care facilities—unlike the OSHA rule—provides no such testing mechanism.

“We have a higher bar for health-care workers given their critical role in ensuring the health and safety of their patients. And so it’s either vaccination or an exemption (religious or medical) under the rules outlined,” a senior administration official told reporters Wednesday evening.

The CMS rule will “preempt any inconsistent state or local laws, including laws that ban or limit an employer’s authority to require vaccination, masks, or testing,” the agency said in a press release.

Mark Parkinson, president and CEO of AHCA/NCAL, which represents about 14,000 nursing homes, said in a statement Thursday that his organization supports the goal of the mandate. But “we are concerned that the execution will exacerbate an already dire workforce crisis in long term care,” he said. “A hard deadline with no resources for providers or glide path for unvaccinated workers is likely to push many out the door and ultimately, threaten residents’ access to long term care.”

LeadingAge, which represents nonprofit nursing homes and other aging services providers, expressed similar concerns.

“The policy could further complicate staffing issues (including the prospect of additional departures) for our members who are already contending with longstanding workforce challenges exacerbated by the pandemic. We cannot overemphasize the need for staffing support and will continue to make our members’ needs known to the administration and to CMS,” Katie Smith Sloan, president and CEO of LeadingAge, said in a statement.

Other nursing home industry recommendations were likewise omitted from the interim rule. There was no $25 million campaign to educate staff on getting vaccinated and no $3 billion in Provider Relief Fund money to help implement the mandate.

The vaccine requirement will not apply to assisted living facilities and group homes, which are not regulated by the CMS. Nor will it apply to doctor’s offices, which are not subject to CMS health and safety regulations.

Nursing homes and other long-term care facilities have been the epicenter of the Covid-19 outbreak, accounting for nearly 187,000 deaths and more than 1.4 million infections, according to the Kaiser Family Foundation. Infected staffers are believed to be the main cause of most of the illnesses and deaths.

The Covid-19 vaccines have been available on a priority basis to all health-care workers since their initial approvals in December 2020.

The nursing home industry had set a goal of vaccinating 75% of staff by the end of July, but only 71% have been vaccinated as of Oct. 10, federal data shows. That’s up from about 60% on Aug. 12.

Some 1.3 million people working in nursing homes would fall under the new vaccine requirement, the Biden administration has estimated.

VIDEO: President Biden’s vaccine mandate rule for companies, the likely legal challenges and what to expect next.

‘Hole’ in Federal Mandate

Dombi, of the National Association for Home Care & Hospice, was pleased the compliance deadline of Jan. 4 allows sufficient time for the estimated 11,000 home health agencies and their nearly 1.5 million employees covered by the mandate to comply. He expressed similar relief about the compliance window on behalf of the roughly 5,000-plus hospice providers and their estimated 750,000 workers.

The vaccine rule applies to a wide range of health-care companies that are subject to Medicare “conditions of participation,” the quality-of-care standards that providers must meet in order to treat Medicare beneficiaries. Medicaid has largely adopted these Medicare conditions of participation, Dombi said.

But most of the $100 billion-plus in Medicaid home health-care services provided annually—which represent the vast majority of all home health-care services—are not subject to Medicare conditions of participation, Dombi said.

Dombi estimates that 10,000 to 20,000 of these home and community-based services providers, private-duty nursing providers, personal care providers and home care aides will not be subject to the CMS vaccination mandate. State officials determine what the requirements are for those care providers, Dombi said. And few states have made the Medicare conditions of participation the applicable standards.

A CMS official confirmed during a webinar with stakeholders on Thursday that the mandate won’t apply to Medicaid providers of home and community-based services.

“This requirement only applies to those Medicare- and Medicaid-certified providers and suppliers that are subject to CMS’ health and safety regulations. CMS’ health and safety regulations do not cover providers of home and community-based services,” said Lee Fleisher, CMS chief medical officer and director of the Center for Clinical Standards and Quality.

“So the hole that’s there in this federal mandate may need to get plugged by states and localities to really have the kind of widespread effect that’s being sought,” Dombi said.

Rick Pollack, president and CEO of the American Hospital Association, praised the mandate for setting clear expectations and simplifying compliance standards for providers. “Importantly, they clarify that hospitals will need to comply with only the CMS rule, eliminating unnecessary complexity in implementing vaccine mandates,” Pollack said in a statement.

(Updates with additional reporting throughout.)

To contact the reporter on this story: Tony Pugh in Washington at tpugh@bloomberglaw.com

To contact the editors responsible for this story: Brent Bierman at bbierman@bloomberglaw.com; Karl Hardy at khardy@bloomberglaw.com

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