In The News

Layer Upon Layer of Regulation’: Breaking Down the CMS Vaccination Mandate

Home Health Care News  
By Andrew Donlan | November 8, 2021
 
This article is an exclusive feature available as a part of your subscription to HHCN +
 
Since the Centers for Medicare & Medicaid Services (CMS) released its interim emergency regulation relating to the federal government’s vaccine mandate last Thursday, more clarity has come to the surface.
 
Specifically, CMS has made clear what health care providers are included, what individuals can be exempt and how the mandate will be enforced.
 
What came as somewhat of a surprise was the fact that home- and community-based services (HCBS) providers were not included in the mandate. It instead only applies to providers regulated under the CMS Conditions of Participation (CoPs), which includes home health agencies, and, overall, nearly 76,000 providers and 17 million health care workers.
 
No one knows the exact thought process behind that decision for CMS, Darby Anderson, the chief strategy officer at Addus HomeCare Corporation (Nasdaq: ADUS) and vice chairman of the Partnership for Medicaid Home-Based Care (PMHC), told Home Health Care News.
 
“I assume it was a decision of where to draw the line,” Anderson said. “Using CoPs makes sense, as it is a clear way to define the service and personnel providing it consistently across states which have varied definitions on HCBS personnel types. It is helpful from the perspective of allowing waivers and testing options to keep staff employed.”
 
Because of the enormous complexity that goes into an interim emergency regulation like this one, leaving out HCBS providers allowed CMS to be more concrete with its guidelines.
 
But between the CMS mandate, the Occupational Safety and Health Administration’s (OSHA) coinciding guidelines for private businesses and state mandates, there is a lot for providers to sort through.
 
“It is layer upon layer of regulation and requirements that are not always easy to understand,” Emina Poricanin, managing attorney of Poricanin Law, told HHCN.
 
The CMS mandate doesn’t just apply to patient-facing workers, but full-time telework staff are exempt. It also does not allow for opt-outs, where an individual can instead be tested weekly in lieu of being vaccinated.
 
That could potentially squeeze some workers out of home health care and other health care settings. It could also give providers not included in the emergency regulation an edge, if they are OK with employing unvaccinated workers.
 
Along with HCBS providers, assisted living facilities, group homes and physician’s offices are not subject to the mandate.

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Court Halts COVID-19 Vaccination/Testing Mandate for Businesses

A Federal Court of Appeals temporarily halted the Biden administration's OSHA Emergency Temporary Standard (ETS) that required businesses with over 100 employees to mandate the COVID-19 vaccine or regular testing.

The Stay was issued by a three judge panel at the Fifth Circuit Court of Appeals, following a request by Texas, Utah, Mississippi and South Carolina, as well as businesses who claimed they would be adversely impacted.

The judges wrote: "Because the petitions give cause to believe there are grave statutory and constitutional issues with the Mandate, the Mandate is hereby STAYED pending further action by this court.”  

Read the court’s ruling here:

https://www.ca5.uscourts.gov/opinions/unpub/21/21-60845.0.pdf

 

CDC data shows vaccines 5x more effective than prior COVID-19 infections

Healthcare IT News / By Kat Jercich

Data released by the U.S. Centers for Disease Control and Prevention found that among hospitalized patients with symptoms similar to COVID-19, unvaccinated people with a previous novel coronavirus infection were five times more likely to test positive than fully vaccinated people.  

"These findings suggest that among hospitalized adults with COVID-19-like illness whose previous infection or vaccination occurred 90-179 days earlier, vaccine-induced immunity was more protective than infection-induced immunity against laboratory-confirmed COVID-19," said study authors.  

WHY IT MATTERS  

The agency used data from 187 hospitals in the VISION Network, which includes Columbia University Irving Medical Center, HealthPartners, Intermountain Healthcare, Kaiser Permanente Northern California and Northwest, Regenstrief Institute, and University of Colorado.   

By examining data from adults hospitalized between January and September 2021, it compared the odds of testing positive for COVID-19 among adults who had not received an mRNA vaccine, but who'd had a previous novel coronavirus infection, with individuals who had gotten two Pfizer or Moderna shots.  

The chances of testing positive for COVID-19 were 5.49 times higher among the former group.  

The benefits of vaccination in this particular study appeared to be higher for Moderna recipients and for those older than 65. The agency noted several limitations, including potential misclassification of patients and selection bias.   

The study only examined adults who had tested positive more than three months prior to their hospitalization in order to reduce the chances that their illness was related to an ongoing infection rather than a new one.

It also did not include those who had received only one mRNA vaccine dose, those who obtained their second shot less than two weeks before hospitalization or those who received the Johnson and Johnson vaccine.  

In addition, wrote researchers, "These results might not be generalizable to nonhospitalized patients who have different access to medical care or different healthcare-seeking behaviors, particularly outside of the nine states covered."  

Overall, they said, the messaging remains consistent: Everyone eligible should get the vaccine – including those who have already had COVID-19.    

THE LARGER TREND  

As the COVID-19 pandemic continues, more data has become available about the disease, and about who is particularly vulnerable to it.  

This past month, the CDC published the rates of COVID-19 cases and deaths by vaccine brand for the first time. Although efficacy differed by type, unvaccinated people had a 6.1 times greater risk of testing positive for COVID-19 in August 2021, and an 11.3 times greater risk of dying from the disease.  

But hesitancy still remains an issue. Although digital health tools can help, advocates and strategists say getting shots into arms will require a thoughtful response.  

ON THE RECORD  

"This report focused on the early protection from infection-induced and vaccine-induced immunity, though it is possible that estimates could be affected by time," wrote CDC researchers.   

"Understanding infection-induced and vaccine-induced immunity over time is important, particularly for future studies to consider," they added.

 

Coverage is Available for COVID-19 Vaccinations for Eligible Children Ages 5 - 11

Coverage without cost-sharing is available in Medicare, Medicaid, CHIP, and the commercial health insurance market

Following the U.S. Food & Drug Administration’s (FDA) recent action authorizing the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 in children 5 through 11 years of age and a recommendation from the Centers for Disease Control and Prevention (CDC), the Centers for Medicare & Medicaid Services (CMS) is reminding eligible consumers that coverage is available without cost-sharing under Medicare, Medicaid, the Children’s Health Insurance Program (CHIP), and in the commercial market for this critical protection from the virus without cost sharing. As with all vaccines, the Pfizer-BioNTech COVID-19 Vaccine was tested thoroughly in this age group prior to its authorization for emergency use. While the effects of COVID-19 for a child can last for several months, the most commonly reported side effects of the COVID-19 vaccine in the clinical trial participants were generally mild to moderate in severity, and most went away within one to two days.

“The COVID-19 vaccine is the best way to keep children safe. The strongest protection against COVID-19, including the Delta variant, is to get vaccinated,” said CMS Administrator Chiquita Brooks-LaSure. “I encourage parents everywhere to talk with their pediatrician, school nurse, or other trusted healthcare provider about any questions they may have and to get their children vaccinated as soon as possible.” 

Thanks to the American Rescue Plan Act of 2021 (ARP), nearly all Medicaid and CHIP beneficiaries are eligible to receive coverage of COVID-19 vaccines and their administration without cost-sharing. Beneficiaries with Medicare pay nothing for COVID-19 vaccines or their administration, and there is no applicable copayment, coinsurance, or deductible. COVID-19 vaccines and their administration will also be covered without cost-sharing for eligible consumers of most issuers of health insurance in the commercial market. People can visit vaccines.gov (English) or vacunas.gov (Spanish) to search for nearby locations to receive a vaccine.

Additionally, under the terms of the CDC COVID-19 Vaccination Program Provider Agreement, health care providers and other entities administering COVID-19 vaccines must agree not to deny anyone a COVID-19 vaccination based on their health coverage status and must also agree to administer COVID-19 vaccines at no out-of-pocket cost to recipients. More information regarding the CDC COVID-19 Vaccination Program Provider Requirements and how the COVID-19 vaccine is provided through that program at no cost to recipients is available at https://www.cdc.gov/vaccines/covid-19/vaccination-provider-support.html and through the CMS COVID-19 Provider Toolkit. 

 

Biden-Harris Administration Issues COVID-19 Vaccination Mandate Details

Last Thursday, both the Omnibus COVID-19 Health Care Staff Vaccination interim final rule with comment period (IFC) and the OSHA Emergency Temporary Standard (ETS) were posted for public inspection.

The Centers for Medicare & Medicaid Services (CMS) will require full COVID-19 vaccination for all employees at Medicare and Medicaid-participating healthcare facilities by Jan. 4, 2022, and OSHA will require all employees at businesses with 100 or more workers to be vaccinated by the same date or to get tested weekly for the virus and wear a face mask in the workplace.

Specifically, the official announcement states that, “Facilities covered by this regulation must establish a policy ensuring all eligible staff have received the first dose of a two-dose COVID-19 vaccine or a one-dose COVID-19 vaccine prior to providing any care, treatment, or other services by December 5, 2021.

“All eligible staff must have received the necessary shots to be fully vaccinated – either two doses of Pfizer or Moderna or one dose of Johnson & Johnson – by January 4, 2022. The regulation also provides for exemptions based on recognized medical conditions or religious beliefs, observances, or practices. Facilities must develop a similar process or plan for permitting exemptions in alignment with federal law.”

Booster shots are not mandated.

Read additional details about the Application of the orders, approved Accommodations, Enforcement, Resources and more on HHAC’s Vaccination Orders Member Resource Center

https://hcac.memberclicks.net/hhac-member-resource-center--covid-19-vaccination-orders

 
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