In The News

Delay Ahead for Pfizer's COVID-19 Vaccine for Kids Under 5

By Lauran Neergaard and Matthew Perrone, Associated Press | Posted - Feb. 11, 2022 at 2:29 p.m.

WASHINGTON — U.S. regulators on Friday put the brakes on their push to speed Pfizer's COVID-19 to children under 5, creating major uncertainty about how soon the shots could become available.

The Food and Drug Administration had urged Pfizer and its partner BioNTech to apply for authorization of extra-low doses of its vaccine for the youngest children before studies were even finished — citing the toll the omicron variant has taken on children.

Next week, FDA advisers were supposed to publicly debate if youngsters should start getting two shots before it's clear if they'd actually need a third.

But Friday, the FDA reversed course and said it had become clear it needed to wait for data on how well that third shot works for this age group. Pfizer said in a statement that it expected the data by early April.

FDA's vaccine chief Dr. Peter Marks said he hoped parents would understand that the decision to delay was part of the agency's careful review and high scientific standards.

"We take our responsibility for reviewing these vaccines very seriously because we're parents as well," Marks told reporters during a teleconference.

Pfizer's early data showed two of the extra-low doses were safe for kids under 5 and strong enough to give good protection to babies as young as 6 months. But once tots reached the preschool age — the 2- to 4-year-olds — two shots didn't rev up enough immunity.

And a study of a third dose isn't finished yet — meaning the FDA was considering whether to authorize two shots for now with potentially a third cleared later, something highly unusual.

Friday, the FDA didn't say exactly what new data Pfizer was providing except that it involved the critical issue of a third dose.

"We believe additional information regarding evaluation of a third dose should be considered as part of our decision-making," the agency said in a statement.

The nation's 18 million children under 5 are the only age group not yet eligible for vaccination.

 

CMS Home Healthcare Policy Reduced Hospital Readmissions

Health Payer Intelligence

- The CMS post-acute care transfer (PACT) policy and the use of home healthcare helped reduce hospital readmissions for recently discharged patients and lower hospital expenditures, according to a 
study published in the American Journal of Managed Care.

The CMS PACT policy aims to prevent overpayment to hospitals for stays that receive post-acute transfers during discharge. Post-acute transfers include discharges to a skilled nursing facility, hospice, long-term acute care hospital, or a discharge with provider orders for home healthcare within three days of discharge.

Under the policy, hospitals receive reduced payments for shorter-than-average patient stays that fall into certain diagnosis-related groups. 

To understand if home healthcare helped improve patient outcomes, researchers looked at patients who experienced discharges to home healthcare under the PACT policy in 2018. They gathered data on Humana Medicare Advantage members from claims submissions, CMS mortality data, enrollment files, primary care contracts, and program participation documents.

The researchers performed an instrumental variable analysis that considered hospital preference for discharge to home healthcare to control for confounding variables and produce the most accurate results.

The study included data from 19,231 patients; 4,160 received discharge to home healthcare, while 15,071 had a discharge to home.

Patients who received home healthcare saw better health outcomes compared to patients who did not, the study showed. Patients in the home healthcare group had a 60 percent smaller risk of readmission after 30 days. Readmission rates were lower for the home healthcare group at the 60- and 90-day marks as well.

Additionally, patients who received home healthcare experienced lower costs compared to patients who had a discharge to home, perhaps due to the reduced rate of hospital readmissions. Hospital spending for the home healthcare group was $239 less per patient, researchers found.

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Congress Passes Ban on Mandatory Arbitration of Sexual Harassment and Assault Claims

SESCO Management Consultants

  • · The U.S. House of Representatives and Senate have passed legislation that will invalidate and render unenforceable mandatory arbitration clauses in cases “relating to sexual harassment disputes or sexual assault disputes.” The legislation is now only an expected President Biden signature away from becoming law.
  • · Assuming its enactment, the legislation will apply to “any dispute or claim that arises or accrues on or after the date of enactment,” meaning it will not retroactively apply to ongoing arbitrations but will take immediate effect going forward.
  • · To invoke the protections of the bill and nullify a mandatory arbitration provision as to the entire case, employers with mandatory arbitration provisions may start to see claims of sexual harassment or sexual assault inserted into cases primarily concerning other protected categories or activities.
  • · While the legislation does not go so far as to invalidate a mandatory arbitration clause in any context just because it is written broadly enough to encompass a sexual assault dispute or sexual harassment dispute, employers should still review their mandatory arbitration agreements and consider revising them to carve out claims of sexual assault and sexual harassment.

If employers have any questions or concerns, we recommend they contact us to ensure compliance. For assistance, contact us at 423-764-4127 or by email at [email protected]

To ensure that you are receiving the most up to date information, please subscribe to SESCO News Blasts.

 

 

Workforce Top Issue for Homecare Industry

HomeCare Magazine

SCOTTSDALE, Arizona (February 8, 2022)—At the Home Care 100 conference, there was one overwhelming message from leaders in the home health and hospice industry: Workforce is the No. 1 issue facing homecare now—and for the foreseeable future. 

"We have a real caregiver problem that’s going to last 20+ years. This is the new normal, we’re going to have a workforce shortage that’s going to last forever,” David Ellis, president and founder of Home Care 100, told the conference as he opened the first panel. The conference brings together top-level decisionmakers from the post-acute industry; this year it is celebrating its 20th anniversary. 

Even Former Vice President Al Gore got in on the conversation, pointing out the hiring pressures in his afternoon virtual speech to the audience. 

“There is a crisis in your industry in recruiting and retaining the workers that you absolutely depend upon,” Gore said. He encouraged the homecare operators present to increase wages—and said there should be increased reimbursement to make sure that happens, as well as technological changes to make their lives easier and a need to allow for open legal immigration to fill critical positions. 

Chris Gerard, president and chief operating officer of Amedisys Home Health & Hospice, said that an aging population will create hiring pressures that could last for years, even if the current crisis of clinical hiring that’s been driven by the pandemic subsides. 

“Longer term, there’s still going to be some lingering effects of this pandemic. A lot of nurses have left the profession, temporarily or altogether,” he said. “The demand is here and the demand will be here for quite some time. We’re going to run into a supply and demand issue for the next several years.” 

One of the answers is creating a better culture and lifestyle, several participants said, including David Baiada, CEO of the nonprofit national agency BAYADA Home Health Care, which moderator Tim Craig, vice president and chief content director for Lincoln Healthcare Leadership, which organized the conference, called a “gold standard” for company culture. 

“It’s ironic,” Baiada said. “We’re a professional services industry and for the first time, we’re finally talking about people.” 

“This is a permanent crisis,” he continued. “This is not going away. It’s not a moment where we’re going to be worried about it for a little while, this is a potentially existential crisis about access to care … and not to have this as our No. 1 conversation would be a tragedy.” 

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Former CMS Administrator Seema Verma Says Medicare Advantage Has “Green Light"

HomeCare Magazine

SCOTTSDALE, Arizona (February 8, 2022)—Medicare Advantage programs are likely to continue to grow at a rapid pace, replacing traditional Medicare coverage for America’s seniors in increasing numbers, former Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma said Tuesday. 

“I think Medicare Advantage is going to continue to grow gangbusters,” Verma told attendees at the Home Care 100 conference, which gathers CEOs and other leaders in home health, hospice and personal care. “It will be at 50% in short order.” 

That’s not necessarily good news for home health providers. The looming domination of Medicare Advantage (MA) and other managed plans—and the difficulty of negotiating with them—was a recurring theme at the conference. About 42% of Medicare beneficiaries were enrolled in MA plans in 2021, according to the Kaiser Family Foundation. 

“As MA continues to grow, even if you put all of us together at this table, we don’t have enough market share to begin to where we have some symmetry of power,” said Bruce Greenstein, chief strategy and innovation officer at LHC Group; he shared the dais with leadership from BAYADA Home Health Care, Kindred at Home and Amedisys Home Health Care & Hospice—some of the larger homecare companies in the country. 

“It’s time for a serious wakeup call; we need to stop sugar coating what’s happening right now,” Greenstein continued. 

Bill Dombi, president of the National Association for Homecare and Hospice, said that the industry will be looking closely at Medicare’s and Medicare Advantage’s encounter data and advocates are prepared to either push MA plans or fight them depending on outcomes. 

“If we have to work with them for success, we’ll work with them for success; if we have to challenge them for success, we’ll challenge them for success,” Dombi said on a panel. 

Verma encouraged providers to use their own patient data to prove value and gain a strong platform for negotiating with MA and other payers. She also said they could look at providing some of the supplemental benefits that go with managed care plans. 

She also said the same data—as well as the rise of predictive analytics—can lead to reduced costs and better outcomes in all aspects of health care, especially home- and community-based services. And she praised in-home care for allowing providers to see and address the social determinants of health that aren’t apparent with a primary office visit. 

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