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Tuesday, December 1, 2020

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

Acceleron ACE-1334 nabs U.S. Orphan drug tag for connective tissue disorder

 

  • The FDA has designated Orphan Drug status to Acceleron Pharma's (NASDAQ:XLRN) ACE-1334 for the treatment of systemic sclerosis, an autoimmune rheumatic disease characterized by excessive production and accumulation of collagen, called fibrosis, in the skin and internal organs.
  • The Company intends to initiate a Phase 1b/Phase 2 trial in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD) in 2021, an autoimmune connective tissue disorder characterized by immune dysregulation.
  • The Orphan Drug tag may provide grant funding toward clinical trial costs, tax advantages, FDA user-fee benefits, and seven years of market exclusivity in the U.S. following marketing approval.
  • ACE-1334 is a TGF-beta superfamily-based ligand trap designed to bind and inhibit TGF-beta 1 and 3 ligands but not TGF-beta 2, which are believed to be key signaling factors in the pathogenesis of fibrotic disease.
  • https://seekingalpha.com/news/3640270-accelerons-aceminus-1334-nabs-u-s-orphan-drug-tag-for-connective-tissue-disorder

Regenxbio starts study of gene therapy for rare metabolic disorder

 

FDA accepts BridgeBio/QED's infigratinib application for bile duct cancer

 

  • The FDA accepts for review BridgeBio Pharma (NASDAQ:BBIO) and affiliate QED Therapeutics' New Drug Application (NDA) for infigratinib for the first-line treatment of advanced/metastatic cholangiocarcinoma (bile duct cancer) with FGFR2 gene fusions or translocations.
  • Infigratinib a lead drug candidate is an orally administered, FGFR1-3 selective tyrosine kinase inhibitor.
  • The NDA has been granted priority review designation and is being reviewed under the Real-Time Oncology Review (RTOR) pilot program, an initiative of the FDA’s Oncology Center of Excellence designed to expedite the delivery of safe and effective cancer treatments to patients.
  • Additionally, BridgeBio will submit for review in Australia and Canada under Project Orbis, an initiative of the FDA’s Oncology Center of Excellence that allows for concurrent submission and review of oncology drugs among participating international regulatory agencies.
  • BBIO's NDA for fosdenopterin in molybdenum cofactor deficiency (MoCD) Type A was accepted in September 2020.
  • https://seekingalpha.com/news/3640300-fda-accepts-bridgebio-pharma-qeds-infigratinib-application-for-bile-duct-cancer