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Tuesday, December 1, 2020

Col. lawmakers demand counties comply with covid curbs to get relief money

 Colorado lawmakers are trying to use coronavirus relief dollars as a way to persuade counties to follow Gov. Jared Polis’ COVID-19 restrictions. 

A bipartisan bill that won preliminary approval on Monday, the first day of a special legislative session, would withhold direct-aid payments to small businesses and arts organizations in counties that refuse to comply with mandates issued by the state’s health department to slow the spread of the coronavirus. 

The legislation appears to target conservative Weld County, where commissioners have said they won’t enforce red-level coronavirus mandates imposed on the county Nov. 22, including a ban on indoor dining and a ban on all personal gatherings. 

“This money was directed toward those businesses that have been most impacted by the public health orders,” said Sen. Faith Winter, a Westminster Democrat who is spearheading the legislation. “If your county is refusing to (enforce) public health orders, the impacts are different.”

One Democratic lawmaker suggested a similar test should apply to restaurants and bars that receive a temporary tax break under consideration in a separate bill.

The attempt to compel counties to comply with guidelines from the state Department of Public Health and Environment comes amid months of tension between Polis and Democratic lawmakers, who have pushed for the restrictions, and Republicans who generally want businesses to operate with minimal restrictions. 

The measure — which includes two Republican sponsors — would allow counties to apply to tap into $37 million in relief provided by the legislature. The state would send the money to counties, which in turn would handle distributing up to $7,000 in one-time payments to eligible small businesses, like restaurants, bars, movie theaters and event venues. Counties under more severe coronavirus restrictions because of rising cases and hospitalizations would get priority in receiving the money. 

“It’s not right. It’s blackmail on the governor’s part and Democrats’ part,” said Sen. John Cooke, a Weld County Republican, referring to the compliance clause. “It’s not fair at all.” 

Cooke said he stands by the decision of Weld County’s commissioners. “They know what’s more important for Weld County than the governor does,” he said. “The governor hates Weld County.”

Sen. Bob Gardner, R-Colorado Springs, said the compliance clause is akin to totalitarianism.

“This isn’t a bill intended to be a bill help small businesses as much as it is a bill to punish rebellious counties, to punish those that would challenge,” he said. “This bill doesn’t befit the state of Colorado. This bill befits the People’s Republic of China.”

Senate Majority Leader Steve Fenberg, D-Boulder, criticized Republicans for objecting to the compliance clause. He said Gardner’s remarks were offensive.

“If you’re operating basically normally, you probably don’t need this money as much,” he said.

Tony Gagliardi, the Colorado state director for the National Federation of Independent Businesses, said he’s concerned about businesses in Weld County being unfairly blocked from accessing the aid through no fault of their own.

“You’re penalizing the small businesses because of actions by the county commissioners that are out of their hands,” he said.

Weld County’s five commissioners did not respond to messages seeking comment on Monday.

Sen. Rob Woodward, a Loveland Republican, worried during a committee hearing on the legislation that counties may impose more stringent restrictions on their businesses in order to access the direct payments. “Are we encouraging counties who are trying to chase money to keep their businesses afloat?” he asked.

Sen. Kevin Priola, a Henderson Republican who is a sponsor of the direct-aid bill, said no. 

“There’s not nearly enough money to encourage municipalities or businesses around the state to elevate (their restrictions) just for running after this,” Priola said.  

Winter, the lead sponsor, said the plan is to offer an amendment providing a carveout for businesses located in cities that comply with public health guidelines, even if they are in a county that refuses to do so. Those cities would be able to ask the state, rather than their county, to distribute the direct-aid dollars to them.

Democrats are eyeing similar compliance clauses for other special-session coronavirus relief legislation. 

Rep. Shannon Bird, D-Westminster, said a bill to provide a four-month tax break to restaurants and bars should include a provision that requires business owners wishing to to participate in the sales tax relief plan to certify that they were in compliance with state and local public health.

The state should “prioritize businesses that are doing the right thing and protect public health,” she said.

https://coloradosun.com/2020/12/01/small-business-aid-coronavirus-weld-count/

California to get 327,000 doses of COVID-19 vaccine in December

 Gov. Gavin Newsom said 327,000 doses of the new Pfizer coronavirus vaccine are headed to California in mid-December.

Newsom announced the expected delivery of the vaccines on Twitter Monday. He said transparency, equity and safety will continue to be the state’s top priorities as officials begin phase one of the distribution process.

Pfizer Inc. and its German partner BioNTech asked the Food and Drug Administration to allow emergency use of their vaccine earlier this month after the companies found it to be 95% effective at preventing mild to severe COVID-19 disease in a large, ongoing study.

FDA’s scientific advisers are holding a public meeting Dec. 10 to review Pfizer’s request and send a recommendation to the FDA.

Newsom warned Monday that without more restrictions or changes in behavior, the number of coronavirus patients could double or triple in a month.

Right now nearly 7,800 patients are hospitalized. But the biggest concern is intensive care cases, which increased 67% in the past two weeks. If that continues, it would push ICU beds to 112% of capacity by mid-December. The state’s top health official says ICU capacity will be the primary trigger as state officials consider more restrictions.

Newsom said a more sweeping stay-at-home order could soon be imposed in the vast majority of California in hopes of preventing the health care system from being overrun.

https://fox5sandiego.com/news/california-news/california-to-receive-327000-doses-of-covid-19-vaccine-in-december/

Officials divided on when first Covid-19 vaccine doses will be available, and for whom

 

Divisions are emerging among top U.S. officials over when the country’s first Covid-19 vaccine will be authorized — and who should be at the front of the line to get vaccinated.

Robert Redfield, the director of the Centers for Disease Prevention and Control, and others have suggested vaccination of Americans could begin by the end of next week. In their scenario, the Food and Drug Administration will authorize emergency use of a vaccine developed by Pfizer and BioNTech almost immediately after a Dec. 10 meeting of an advisory committee, which is expected to recommend authorization.

But the head of the FDA center responsible for any such authorization said in a presentation to patient groups last week that it may take several days or even “a few weeks” after the advisory committee meeting before his office gives the vaccine a green light.

“You may have heard in the media that it will be a few days. It’s possible that it could be within days, but our goal is to make sure it is certainly within a few weeks,” said Peter Marks, who heads the FDA’s Center for Biologics Evaluation and Research. The remarks by Marks, who did not respond to a request for comment from STAT, were first reported by CNN.

Separately, STAT has learned that senior leaders in the Trump administration’s coronavirus response are pressing for adults 65 years old and older to be given first access to the vaccine. That approach contradicts the position of a committee that advises the Centers for Disease Control and Prevention on vaccine policy; the Advisory Committee on Immunization Practices has signaled for months that it will recommend health care providers be at the front of the vaccination line.

The conflicting views risk sending mixed signals to public health authorities at the state level who are racing to try to finalize plans for deploying limited doses of vaccines within, as the administration insists, 24 hours of the vaccines being cleared for use by the FDA. “It’s going to be messy,” said a senior government official, who spoke on condition of anonymity.

The Advisory Committee on Immunization Practices is meeting in an emergency session Tuesday to vote on a recommendation that would enshrine its position on health care providers — and add residents of long-term care facilities to “Phase 1a” of the vaccination priority schedule. Though some members of the committee have expressed concerns about putting long-term care residents in the first group, none has voiced an objection to giving first access to health workers.

José Romero, the committee’s chairman, said all of the analyses the committee has conducted indicate that vaccinating these two groups first provides the best “bang for our buck” when vaccine supplies are limited — as they will be for the first month or two of the vaccine rollout. The U.S. expects to have enough vaccine from Pfizer and Moderna — whose vaccine is expected to be authorized for use a week or so after the Pfizer product — to vaccinate 20 million Americans in December and another 25 million in January.

There are an estimated 21 million people working in health care in the country and roughly 3 million people living in long-term care. As of last week, nearly 230,000 health workers have contracted Covid-19 and 822 have died. The toll among long-term care residents is very high — they make up about 6% of the country’s Covid cases and 39% of deaths, according to CDC data.

“We will protect [health workers], allow them to continue to provide care in an environment where cases are surging and there appears to be no control over the spread,” Romero, secretary of the Arkansas Department of Health, told STAT. “And … the second group, that group of individuals that live in long-term care facilities that have high morbidity and mortality, we can decrease that number significantly when compared to the other groups.”

Earlier this fall, an expert panel established by the National Academy of Medicine also recommended that high-risk health care workers — who are now struggling to cope with a massive increase in cases — should be given access to Covid vaccines first.

The fact that the ACIP is voting on a recommendation at all now is a reversal for the committee, which had previously said it would wait until specific vaccines had been authorized by the FDA before making recommendations on their use.

Operation Warp Speed, the government’s initiative to fast-track development and delivery of vaccines, pressed the group to hold a vote earlier, a source told STAT, so that states — which have the ultimate say on who gets doses — could better determine where to have the first deliveries sent. States have been given until Friday to signal where they want those deliveries to be deployed.

At the same time, HHS Secretary Alex Azar and White House coronavirus task force coordinator Deborah Birx are pushing to have seniors precede health workers in the vaccine rollout schedule, because of the high death rate among older and elderly adults, according to the senior government official.

In an interview with Fox News recently, Redfield also appeared to signal a priority scheme that differs from ACIP’s expected schedule, saying nursing home residents would be first, followed by “some combination of health care providers and individuals at high risk for a poor outcome.”

More than 100 million Americans have health conditions that put them at risk of developing severe disease if they contract Covid-19, the CDC estimates.

STAT asked the White House and HHS for comment on Azar’s and Birx’s positions on vaccine priorities. A White House spokesman deferred to HHS.

“Secretary Azar has insisted that science and data drive the process for vaccines and therapeutic development, and will do so for vaccine allocation and distribution,” an HHS spokesman said. “This means the doctors will make their recommendations, and ultimately the governors will make a determination of what works best for their communities based on input they receive and the circumstances on the ground.”

Including long-term care residents in the first phase of vaccination may satisfy the desire to vaccinate the most vulnerable early in the rollout.

The challenging characteristics of the Pfizer vaccine — it must be stored at -94 Fahrenheit — may also impede any effort to push people 65 and older closer to the front of the line. Most seniors get their health care from primary care physicians, who would not have the ultracold freezers needed to store the Pfizer vaccine. In the case of long-term care facilities, however, Operation Warp Speed has signed contracts with major pharmacy chains to run the vaccination efforts in those locations.

It’s not yet clear how the ACIP will vote on including long-term care residents in the first phase of vaccination. During a discussion at a meeting last week, several members supported the idea. But others raised concerns about the fact there aren’t yet data to indicate how well the first vaccines work in elderly people who are frail.

“I recognize that they have suffered some of the greatest burden. But … we have no efficacy data in this population because it hasn’t been studied,” said Robert Atmar, an infectious diseases professor at Baylor College of Medicine. “We know from flu vaccine studies that this population tends to have less efficacy of flu vaccine compared to other persons.”

Romero said Tuesday’s vote is a critical one for the ACIP.

“In my tenure of now almost seven years on the ACIP, this is the most serious vote that we have ever taken,” Romero said. “They’re all serious, but this one is very, very significant. And we have given a lot of time and thought to this.”

Once the committee votes, the recommendation will go to Redfield, the CDC director. In the history of this committee, the CDC director has only once overruled a recommendation from the ACIP, related to a program to vaccinate health workers against anthrax after the 2001 anthrax attacks.

https://www.statnews.com/2020/11/30/divisions-emerge-among-u-s-officials-over-when-first-covid-19-vaccine-doses-will-be-available-and-for-whom/

CMS Launches Hospital-at-Home Program to Free Up Hospital Capacity

 As an increasing number of health systems implement "hospital-at-home" (HaH) programs to increase their traditional hospital capacity, the Centers for Medicare & Medicaid Services (CMS) has given the movement a boost by changing its regulations to allow acute care to be provided in a patient's home under certain conditions.

CMS announced last week it was launching its Acute Hospital Care at Home program "to increase the capacity of the American health care system" during the COVID-19 pandemic.

At the same time, the agency announced it was giving more flexibility to ambulatory surgery centers (ASCs) to provide hospital-level care.

CMS said its new HaH program is an expansion of the Hospitals Without Walls initiative that was unveiled last March. Hospitals Without Walls is a set of "temporary new rules" that provides flexibility for hospitals to provide acute care outside of inpatient settings. Under those rules, hospitals are able to transfer patients to outside facilities, such as ASCs, inpatient rehabilitation hospitals, hotels, and dormitories, while still receiving Medicare hospital payments.

Under CMS' new Acute Hospital Care at Home, which is not described as temporary, patients can be transferred from emergency departments or inpatient wards to hospital-level care at home. CMS said the HaH program is designed for people with conditions such as the acute phases of asthmacongestive heart failure, pneumonia, and chronic obstructive pulmonary disease. Altogether, CMS said, more than 60 acute conditions can be treated safely at home.

However, the agency didn't say that facilities can't admit COVID-19 patients to the hospital at home. Rami Karjian, MBA, cofounder and CEO of Medically Home, a firm that supplies health systems with technical services and software for HaH programs, told Medscape Medical News that several Medically Home clients plan to treat both COVID and non-COVID patients at home when they begin to participate in the CMS program in the near future.

CMS said it consulted extensively with academic and private industry leaders in building its HaH program. Before rolling out the initiative, CMS noted, it conducted successful pilot programs in leading hospitals and health systems. The results of some of these pilots have been reported in academic journals, the agency said.

Participating hospitals will be required to have specified screening protocols in place before beginning acute care at home, CMS announced. An in-person physician evaluation will be required before starting care at home. A nurse will evaluate each patient once daily in person or remotely, and either nurses or paramedics will visit the patient in person twice a day.

In contrast, Medicare regulations require nursing staff to be available around- the-clock in traditional hospitals. So CMS has to grant waivers to hospitals for HaH programs.

While not going into detail on the telemonitoring capabilities that will be required in the acute hospital care at home, the release said, "Today's announcement builds upon the critical work by CMS to expand telehealth coverage to keep beneficiaries safe and prevent the spread of COVID-19."

More Flexibility for ASCs

The agency is also giving ASCs the flexibility to provide 24-hour nursing services only when one or more patients are receiving care onsite. This flexibility will be available to any of the 5700 ASCs that wish to participate, and will be immediately effective for the 85 ASCs currently participating in the Hospital Without Walls initiative, CMS said.

The new ASC regulations, CMS said, are aimed at allowing communities "to maintain surgical capacity and other life-saving non-COVID-19 [care], like cancer surgeries." Patients who need such procedures will be able to receive them in ASCs without being exposed to known COVID-19 cases.

Similarly, CMS said patients and families not diagnosed with COVID-19 may prefer to receive acute care at home if local hospitals are full of COVID patients. In addition, CMS said it anticipates patients may value the ability to be treated at home without the visitation restrictions of hospitals.

Early HaH Participants

Six health systems with extensive experience in providing acute hospital care at home have been approved for the new HaH waivers from Medicare rules. They include Brigham and Women's Hospital (Massachusetts); Huntsman Cancer Institute (Utah); Massachusetts General Hospital (Massachusetts); Mount Sinai Health System (New York City); Presbyterian Healthcare Services (New Mexico); and UnityPoint Health (Iowa).

CMS said that it's in discussions with other healthcare systems and expects new applications to be submitted soon.

To support these efforts, CMS has launched an online portal to streamline the waiver request process. CMS said it will closely monitor the program to safeguard beneficiaries and will require participating hospitals to report quality and safety data on a regular basis.

Support From Hospitals

The first health systems participating in the CMS HaH appear to be supportive of the program, with some hospital leaders submitting comments to CMS about their view of the initiative.

"The CMS has taken an extraordinary step today, facilitating the rapid expansion of Hospitalization at Home, an innovative care model with proven results," said Kenneth L. Davis, MD, president and CEO of the Mount Sinai Health System in New York City. "This important and timely move will enable hospitals across the country to use effective tools to safely care for patients during this pandemic."

David Levine, MD, assistant professor of medicine and medical director of strategy and innovation for Brigham Health Home Hospital in Boston, was similarly laudatory: "Our research at Brigham Health Home has shown that we can deliver hospital-level care in our patients' homes with lower readmission rates, more physical mobility, and a positive patient experience," he said. "During these challenging times, a focus on the home is critical. We are so encouraged that CMS is taking this important step, which will allow hospitals across the country to increase their capacity while delivering the care all patients deserve."

Scaling Up Quickly

If other hospitals and health systems recognize the value of HaH, how long might it take them to develop and implement these programs in the midst of a pandemic?

Atrium Health, a large health system in the Southeast, ramped up a hospital at home initiative last spring for its 10 hospitals in the Charlotte, North Carolina area, in just 2 weeks. However, it had been working on the project for some time before the pandemic struck. Focusing mostly on COVID-19 patients, the initiative reduced the COVID-19 patient load by 20%-25% in Atrium's hospitals.

Medically Home, the HaH infrastructure company, said in a news release that it "enables health systems to establish new hospital-at-home services in as little as 30 days." Medically Home has partnered in this venture with Huron Consulting Group, which has about 200 HaH-trained consultants, and Cardinal Health, a large global medical supplies distributor.

Karjian told Medscape Medical News that he expects private insurers to follow CMS' example, as they often do. "We think this decision will cause not only CMS but private insurers to cover hospital at home after the pandemic, if it becomes the standard of care, because patients have better outcomes when treated at home," he said.

Asked for his view on why CMS specified that patients could be admitted to an HaH only from emergency departments or inpatient settings, Karjian said that CMS wants to make sure that patients have access to brick-and-mortar hospital care if that's what they need. Also, he noted, this model is new to most hospitals, so CMS wants to make sure they start "with all the safety guardrails" in place.

Overall, Karjian said, "This is an exciting development for patients across the country. What CMS has done is terrific in terms of letting patients get the care they want, where they want it, and get the benefit of better outcomes while the nation is going through this capacity crunch for hospital beds."

https://www.medscape.com/viewarticle/941767

Thousands of Doctors' Offices Buckle Under Financial Stress of COVID

 Cormay Caine misses a full day of work and drives more than 130 miles round trip to take five of her children to their pediatrician. The Sartell, Minnesota, clinic where their doctor used to work closed in August.

Caine is one of several parents who followed Dr. Heather Decker to her new location on the outskirts of Minneapolis, an hour and a half away. Many couldn't get appointments for months with swamped nearby doctors.

"I was kind of devastated that she was leaving because I don't like switching providers, and my kids were used to her. She's just an awesome doctor," said Caine, a postal worker who recently piled the kids into her car for back-to-back appointments. "I just wish she didn't have to go that far away."

So does Decker, who had hoped to settle in the Sartell area. She recently bought her four-bedroom "dream home" there.

The HealthPartners Central Minnesota Clinic where Decker worked is part of a wave of COVID-related closures starting to wash across America, reducing access to care in areas already short on primary care doctors.

Although no one tracks medical closures, recent research suggests they number in the thousands. A survey by the Physicians Foundation estimated that 8% of all physician practices nationally — around 16,000 — have closed under the stress of the pandemic. That survey didn't break them down by type, but another from the Virginia-based Larry A. Green Center and the Primary Care Collaborative found in late September that 7% of primary care practices were unsure they could stay open past December without financial assistance.

And many more teeter on the economic brink, experts say.

"The last few years have been difficult for primary care practices, especially independent ones," said Dr. Karen Joynt Maddox, co-director of the Center for Health Economics and Policy at Washington University in St. Louis. "Putting on top of that COVID, that's in many cases the proverbial straw. These practices are not operating with huge margins. They're just getting by."

When offices close, experts said, the biggest losers are patients, who may skip preventive care or regular appointments that help keep chronic diseases such as diabetes under control.

"This is especially poignant in the rural areas. There aren't any good choices. What happens is people end up getting care in the emergency room," said Dr. Michael LeFevre, head of the family and community medicine department at the University of Missouri and a practicing physician in Columbia. "If anything, what this pandemic has done is put a big spotlight on what was already a big crack in our health care system."

Federal data shows that 82 million Americans live in primary care "health professional shortage areas," and the nation needed more than 15,000 more primary care practitioners even before the pandemic began.

Once the coronavirus struck, some practices buckled when patients stayed away in droves for fear of catching it, said Dr. Gary Price, president of the Physicians Foundation, a nonprofit grant-making and research organization. Its survey, based on 3,513 responses from emails to half a million doctors, found that 4 in 10 practices saw patient volumes drop by more than a quarter.

On the West Coast, a survey released in October by the California Medical Association found that one-quarter of practices in that state saw revenues drop by at least half. One respondent wrote: "We are closing next month."

Decker's experience at HealthPartners is typical. Before the pandemic, she saw about 18 patients a day. That quickly dropped to six or eight, "if that," she said. "There were no well checks, which is the bread-and-butter of pediatrics."

In an emailed statement, officials at HealthPartners, which has more than 50 primary care clinics around the Twin Cities and western Wisconsin, said closing the one in Sartell "was not an easy decision," but the pandemic caused an immediate, significant drop in revenue. While continuing to provide dental care in Sartell, northwest of Minneapolis, the company encouraged employees to apply for open positions elsewhere in the organization. Decker got one of them. Officials also posted online information for patients on where more than 20 clinicians were moving.

The pandemic's financial ripples rocked practices of all sizes, said LeFevre, the Missouri doctor. Before the pandemic, he said, the 10 clinics in his group saw a total of 3,500 patients a week. COVID-19 temporarily cut that number in half.

"We had fiscal reserves to weather the storm. Small practices don't often have that. But it's not like we went unscathed," he said. "All staff had a one-week furlough without pay. All providers took a 10% pay cut for three months."

Federal figures show pediatricians earn an average of $184,400 a year, and doctors of general internal medicine $201,400, making primary care doctors among the lowest-paid physicians.

As revenues dropped in medical practices, overhead costs stayed the same. And practices faced new costs such as personal protective equipment, which grew more expensive as demand exceeded supply, especially for small practices without the bulk buying power of large ones.

Doctors also lost money in other ways, said Rebecca Etz, co-director of the Green Center research group. For example, she said, pediatricians paid for vaccines upfront, "then when no one came in, they expired."

Some doctors took out loans or applied for Provider Relief Fund money under the federal CARES Act. Dr. Joseph Provenzano, who practices in Modesto, California, said his group of more than 300 physicians received $8.7 million in relief in the early days of the pandemic.

"We were about ready to go under," he said. "That came in the nick of time."

While the group's patient loads have largely bounced back, it still had to permanently close three of 11 clinics.

"We've got to keep practice doors open so that we don't lose access, especially now that people need it most," said Dr. Ada Stewart, president of the American Academy of Family Physicians.

Caine, the Minnesota mom, said her own health care has suffered because she also saw providers at the now-closed Sartell clinic. While searching for new ones, she's had to seek treatment in urgent care offices and the emergency room.

"I'm fortunate because I'm able to make it. I'm able to improvise. But what about the families that don't have transportation?" she said. "Older people and the more sickly people really need these services, and they've been stripped away."

https://www.medscape.com/viewarticle/941786

Moderna shares reverse big early gains in bout of profit-taking

 

AdaptHealth acquires Aerocare Holdings for $2B, ups FY2021 outlook

 

  • AdaptHealth (NASDAQ:AHCO) has acquired Orlando, Florida based AeroCare Holdings for $2B, comprising of $1.1B in cash and 31M shares.
  • Founded in 2000, AeroCare is a leading national technology-enabled respiratory and home medical equipment distribution platform in the United States and offers a comprehensive suite of direct-to-patient equipment and services including CPAP and BiPAP machines, oxygen concentrators, home ventilators, and other durable medical equipment products.
  • AdaptHealth intends to fund the cash portion of the consideration and associated costs through incremental debt and has committed debt financing from Jefferies Finance LLC.
  • The combined company will operate under the name AdaptHealth, and Luke McGee, CEO of AdaptHealth, and Steve Griggs, CEO of AeroCare, will jointly lead the company as Co-CEOs. Josh Parnes will continue to serve as President.
  • The acquisition is expected to close in 1Q21 and estimated $50M run-rate cost synergies.
  • The company reaffirmed FY2020 guidance of Revenue $1B-1.04B vs. consensus of $1.03B and Adjusted EBITDA $186M-194M vs. consensus of $180.7M and increased FY2021 outlook for net revenue from a range of $1.30B-$1.40B to a range of $2.05B-$2.20B vs. consensus of $1.37B, Adjusted EBITDA from a range of $260M-$280M to a range of $480M-$515M vs. consensus of $259M and Adjusted EBITDA less Patient Equipment Capex from a range of $180M-$200M to a range of $300M-$330M.
  • https://seekingalpha.com/news/3640231-adapthealth-acquires-aerocare-holdings-for-2b-and-raises-fy2021-outlook