Hospitals that don’t submit daily COVID-19 data could lose participation in Medicare, Medicaid

US Department of Health and Human Services moves to Microsoft Office 365

Hospitals currently not reporting daily COVID-19 data have a few months to get in compliance or risk being thrown out of Medicare and Medicaid.

The Department of Health and Human Services (HHS) announced Tuesday it will send notices to all hospitals over their requirements for reporting COVID-19 data to the Trump administration.

Any hospital not in compliance with the daily reporting requirements will have 14 weeks to get in line or risk their participation in Medicare and Medicaid, officials said.

The agency gave an enforcement timeline that gives “hospitals ample opportunity to come into compliance,” said Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma on a call with reporters Tuesday.

The Trump administration wants hospitals to submit daily data that includes COVID-19 deaths and hospitalizations as well as patients currently in the intensive care unit with the virus. Hospitals must submit data on the ages of patients admitted with suspected COVID-19 infections. Facilities need to also report their inventory of the COVID-19 therapy Remdesivir, any staffing shortages and the number of ventilators. Every week hospitals also report data on their personal protective equipment on hand and supply of critical medications.

Facilities now must also report on new data for influenza cases. “The new requirements will allow us to gather critical information on influenza at hospitals across the U.S.,” said Centers for Disease Controls and Prevention Director Robert Redfield, M.D.

Verma said that the large majority of hospitals in CMS’ system are already reporting this data to the agency. CMS will also give hospitals that are not in compliance a wide berth to get them into compliance.

Hospitals will be sent multiple notices over the 14-week timeline to get their data reporting in line.

“This work of getting hospitals into compliance around reporting has been an ongoing effort,” Verma said.

CMS proposed the mandatory daily reporting requirements back in August, much to the chagrin of hospital advocates. 

The American Hospital Association (AHA) said that CMS tying Medicare and Medicaid participation to compliance “remains an overly heavy-handed approach that could jeopardize access to hospital care for all Americans,” according to a statement released Tuesday. 

“Today’s interpretive guidance on COVID data reporting does answer some of the questions hospitals and health systems have been asking about compliance since the interim final rule was released six weeks ago,” the group said. “In particular, the Administration will provide hospitals with information on whether their data are making it into HHS Protect and they will give hospitals the necessary time to adjust their data collection to come into compliance if need be.”

The Federation of American Hospitals called the new rules “sledgehammer enforcement.”

“It is both inappropriate and frankly overkill for CMS to tie compliance with reporting to Medicare conditions of participation,” said FAH President and CEO Chip Kahn in a statement.

Providers win Medicare loan extension, DSH relief but lose other asks in stop-gap spending law

https://www.healthcaredive.com/news/providers-win-medicare-loan-dsh-relief-stop-gap-continuing-resolution/586212/?utm_source=Sailthru&utm_medium=email&utm_campaign=Issue:%202020-10-01%20Healthcare%20Dive%20%5Bissue:29992%5D&utm_term=Healthcare%20Dive

Dive Brief:

  • A stop-gap funding bill the president signed into law Thursday will keep the government open until mid-December and includes some provisions that could help providers’ bottom lines. The bill includes relief on advanced and accelerated Medicare loans and a delay of Medicaid payment cuts for disproportionate share hospitals.
  • The legislation extending government funding at current levels was passed by the House earlier this month and approved by the Senate on Wednesday. But more sweeping aid many providers wanted, including more grants for hospitals and a higher federal match rate for Medicaid, were left out of the legislation.
  • Provider groups like the American Hospital Association thanked Congress and the Trump administration for the relief, but AHA noted it would continue lobbying for Medicare loan forgiveness and an extended deadline for the Medicaid DSH cuts.

Dive Insight:

The continuing resolution, and its healthcare provisions within, are pretty much the only direct aid providers can expect from Washington before the looming November presidential election. Congress has largely punted on a fifth round of COVID-19 relief legislation amid partisan deadlock, with Republicans backing a much skinnier package than Democrats.

The CR delays the repayment date for $100 billion in advanced Medicare loans to providers by a year. CMS originally planned to start recouping the loans from providers’ fee-for-service Medicare payments in late July, but unilaterally decided to hold off as lawmakers negotiated the bill.

It also lowers the rate of recoupment to 25% for the first 11 months of repayment, down from the current 100% rate, and 50% for the next six months. Providers have 29 months to pay back the funds in full before interest kicks in, and the interest rate is decreased from 9.6% to 4%.

The original repayment terms and timeline would have been difficult for some cash-strapped doctor’s offices and hospitals to meet, as the burden imposed by COVID-19 hasn’t lifted and is worsening in many areas of the country. Many providers took out the loans earlier this year as a lifeline to stave off insolvency — still a very real threat for many practices.

About 35% of primary care physicians say revenue and income are still significantly lower than pre-pandemic levels, losses that could force them to close, according to a September survey by the Larry A. Green Center and the Primary Care Collaborative.

AHA CEO Rick Pollack said in a Wednesday statement the massive hospital association appreciated the provisions, but would keep pushing for full loan forgiveness, along with extending the delay of DSH cuts for all of the 2021 fiscal year. The CR pushed back the original payment cut start date from Dec. 1 to Dec. 12.

The Association of American Medical Colleges was more worried about the impact on the system.

“We are concerned that health care providers, researchers, students, and public health professionals — who have been our country’s first line of defense against COVID-19 — will remain in limbo despite ongoing challenges that the pandemic presents,” CEO David Skorton said in a statement. “We strongly believe that a larger COVID-19 legislative relief package is essential to our nation’s health.”

However, drastic estimates from providers on financial losses largely haven’t panned out, though public health experts do warn COVID-19 could worsen going into the winter months. AHA estimated U.S. hospitals would see operating profits fall by almost $51 billion in April, the month with the sharpest volume decline because of the pandemic. It’s likelier hospitals lost about half that, according to research from a congressional advisory board, with federal grants covering the worst of short-term losses.

The CR also includes a provision stopping Medicare beneficiaries from seeing a monthly $50 Part B premium hike next year. It will keep the government open until Dec. 11, setting up another funding fight to avoid a shutdown after the election.

 

 

 

 

The N95 shortage America can’t seem to fix

https://www.washingtonpost.com/graphics/2020/local/news/n-95-shortage-covid/?utm_campaign=wp_post_most&utm_medium=email&utm_source=newsletter&wpisrc=nl_most

Nurses and doctors depend on respirator masks to protect them from covid-19. So why are we still running low on an item that once cost around $1?

The patient exhaled. She lifted her tongue for a thermometer. She raised her finger for a blood sugar test, and that’s when she started coughing. One cough can send 3,000 droplets into the air, one droplet can contain millions of coronavirus particles, and now some of those particles were heading for the face of emergency department nurse Kelly Williams.

The nurse inhaled. Strapped over her mouth and nose was an N95 respirator, the disposable filtering mask that has become the world’s most reliable and coveted defense against the virus.

N95s were designed to be thrown away after every patient. By this July afternoon, Williams had been wearing the same one for more than two months.

To get to her, the N95 had traveled from a British factory to a Baltimore warehouse, in a supply chain as tangled and layered as the web of microscopic fibers inside the mask’s filter.

It was purchased by Johns Hopkins Hospital, the famed medical institution that has tracked cases of the novel coronavirus around the world since the pandemic’s start. When its map of dots marking clusters of infections began to show pools of red across the United States, Hopkins was quietly unpacking a stock of personal protective equipment it had been building for over a year — a literal lifesaver when the onslaught of covid-19 cases led to a massive shortage of N95s.

Six months later, that shortage persists, leaving health-care workers exposed, patients at risk and public health experts flummoxed over a seemingly simple question: Why is the world’s richest country still struggling to meet the demand for an item that once cost around $1 a piece?

At Hopkins, nurses are asked to keep wearing their N95s until the masks are broken or visibly dirty. Williams, a 30-year-old from Georgia with a marathoner’s endurance and a nurse’s practicality, went into health care after working for three years in the corporate offices of retailers Abercrombie & Fitch and Under Armour. She understood supply chains. She believed that the makers of N95s, anticipating the pandemic’s eventual end, would invest only so much in expanding production. She believed it was her duty, on top of risking her life for her patients, to make her disposable respirator mask last through as many 12-hour shifts as she could.

When the country was short of ventilators, the companies that made them shared their trade secrets with other manufacturers. Through the powers of the Defense Production Act, President Trump ordered General Motors to make ventilators. Other companies followed, many supported by the government, until the terrifying problem of not enough ventilators wasn’t a problem at all.

But for N95s and other respirators, Trump has used this authority far less, allowing major manufacturers to scale up as they see fit and potential new manufacturers to go untapped and underfunded. The organizations that represent millions of nurses, doctors, hospitals and clinics are pleading for more federal intervention, while the administration maintains that the government has already done enough and that the PPE industry has stepped up on its own.

As the weather cools and the death toll climbs, America’s health-care workers fear that when winter comes, they still won’t have enough respirators. And the longer the shortage lasts, the longer N95s will remain largely out of reach for millions of others who could be protected by them — teachers and day-care workers, factory employees and flight attendants, restaurant servers and grocery store clerks.

While the pandemic that has killed almost 200,000 Americans drags on, Williams will keep trying to conserve her respirator, wearing it as she rushes in and out of virus-filled rooms, touches virus-shedding patients, and now, comforts a covid-positive woman who is having a coughing fit.

“How can I help you feel a little more comfortable?” Williams asked her patient, who was in her 80s. The woman was about to be admitted to the hospital. Her oxygen level was too low, so they had to run tubes of air into her nostrils. If her situation didn’t improve, a ventilator could come next.

This was the routine in the part of the emergency department Williams called “Covidland.” She’d just risked exposure to care for this woman, but she would never get to find out what happened to her.

She could only take a deep breath through her N95, roll her patients upstairs and hope that she would never become one of them.

‘The gauntlet’

Before the N95 was on her face, it was in a plastic wrapper, in a box, on a shelf inside an East Baltimore warehouse four miles from the hospital. The 165,000-square-foot building had concrete floors, rolling doors, overhead lighting — unremarkable, except to a man named Burton Fuller.

Fuller, a 38-year-old father of three, had once planned on becoming a doctor. Instead, he went into hospital supply chains. It was the kind of job that didn’t earn many follow-up questions at dinner parties. But six months after Fuller was hired at Hopkins, the pandemic made him the person that everyone relied on and no one envied. It was up to him to keep 40,000 employees in six hospitals safe.

Even before covid-19, masks were key to that equation. There are surgical masks, which protect a patient from a nurse’s germs, and respirator masks, which protect a nurse from the patient. Humans have recognized the need for protective masks since at least A.D. 77, when Pliny the Elder wrote about wearing animal bladders as face coverings to make breathing easier in lead-filled mines.

The evolution of early masks brought leather beaks stuffed with straw and herbs to ward off the bubonic plague, and long beards that firefighters would wet and clamp between their teeth. Once the far more effective gas mask became standard for coal miners breathing in silica and soldiers facing chemical weapons, engineers at the Minnesota Mining and Manufacturing Company, better known as 3M, started trying to make a protective respirator that wasn’t so bulky. They realized in the 1960s that the technology used to make pre-made gift bows could also make a mask that was a lightweight, molded cup. And so began the single-use respirator as it exists today.

Inside that cup, and more recently, inside the flat-fold versions, is the key component: fibers 1/50th the width of a human hair, blown together in an intricate web that creates an obstacle course for dangerous particles. An electrostatic charge works like a magnet to trap the floating menaces and attach them to the fibers. If an N95 is fitted properly — a metal nose piece folded snugly, no beard in the way — less than 5 percent of even the most difficult-to-catch particles will make it into the lungs.

At Hopkins, Fuller’s job was to get manufacturers to deliver N95s and other equipment directly to the warehouse, rather than through a distributor. In 2019, the shelves started to fill up, and on one of them was the N95 that would make its way to nurse Kelly Williams. The respirator had been made by 3M at a plant in Aycliffe, a town of 7,000 in northern England.

But this Hopkins stockpile was rare in the world of hospitals, where costs were cut by using medical supply companies to provide equipment when it was needed, rather than letting PPE pile up.

Hospital administrators knew that in cases of natural disaster, chemical warfare or what global health officials used to call “Disease X,” the federal government had its own warehouses in secret locations, filled with PPE.

Except that in 2009, while Fuller was in his first job out of college, the H1N1 flu epidemic depleted 85 million N95s from the national stockpile — and the supply was never replenished. In 2013, 2014, 2016 and 2017, public health officials published alarming reports warning of a “massive gap” in what remained. Even more concerning, they said, the vast majority of N95s and the materials needed to manufacture them were now being made in Asia.

The Department of Health and Human Services did fund the invention of a “one-of-a-kind, high-speed machine” that could make 1.5 million N95s per day. But when the design was completed in 2018, the Trump administration did not purchase it.

This year, as the virus spread from Wuhan to Washington state, HHS turned down a January offer from a manufacturer who could make millions of N95s. The agency didn’t start ordering N95s from multiple companies until March 21. Paul Mango, deputy chief of staff for policy at HHS, would later call that timeline “friggin’ light speed … the fastest this has ever been done.”

By then, the United States had 8,000 reported coronavirus cases and 85 deaths, and health-care workers were panicking over PPE shortages.

Fuller’s orders began being canceled. As the Hopkins emergency department was being readied for covid-19 patients, and Williams was being told she would need to start wearing an N95, the hospital’s administration decided not to reveal how many N95s were in the warehouse.

“Only a half a dozen people know,” Fuller said. “Behavioral economics say that if we communicate a number someone perceives as high, they will use the supply more gratuitously. If we communicate a number they perceive as low, they may hoard to ensure there is enough.”

As the boxes of N95s were loaded into trucks headed for Hopkins hospitals, Fuller and a dozen staff members entered what he would come to call “the gauntlet.” Every hospital and health department in the country was competing for N95s and other PPE, a mess of bidding wars, price gouging and worthless knockoff masks. Fuller uncovered one scam when a company CEO, claiming to be based in Indianapolis, didn’t recognize the name of the city’s most famous steakhouse.

“For every mask shipment we have been able to bring in,” Fuller said, “there are 10 or 15 transactions we have had to terminate.”

He worked so much that his wife, home with their children, received flowers from Hopkins executives. He joked about the other crucial stockpile in his life, his wine collection.

Fuller was desperate to make the stockpiled N95s last as long as possible. He wanted every employee wearing one to also wear a face shield, but those, too, were impossible to find.

So at the end of March, the warehouse filled with folding tables spaced six feet apart. Volunteers were given foam strips, elastic straps and sheets of plastic to make homemade shields. At one of the most prestigious medical institutions in the country, they were trying to fix the problem for themselves, with scissors, staplers and hot glue guns.

‘Bracing yourself’

A face shield was clipped to Williams’s belt in the middle of May, when for only the fourth time during the pandemic, she unwrapped a new N95.

After nine weeks in and out of Covidland, she had come to trust in her disposable respirator. It hurt her nose, gave her acne and made breathing hard. But the power of its protection was starting to give her back the feeling of safety she’d lost in March when she and the dozens of colleagues who worked alongside her each shift watched the areas where they’d cared for gunshot victims and heart attack patients turn into isolation rooms. They were tested to make sure the N95s fit their faces and taught to use other respirators that looked like gas masks or blew clean air into a hood.

And then, they were slammed. The first covid patient to go on a ventilator at Hopkins was a 40-year-old who worked out every day. The ambulance bay became a testing center. Williams’s co-workers were crying in the break room. Her patients couldn’t breathe, and then tubes were going down their throats, and then it felt like she couldn’t breathe, like everything she knew about nursing would never be enough.

“Our lives changed overnight,” she said. “You’re bracing yourself for people to die.”

She started silently saying a prayer she knew, every morning, every few hours, then sometimes 20 times a day in Covidland.

God, grant me the serenity to accept the things I cannot change, it began. She said it before her patient started violently shaking and flailing, seizing in his bed. She couldn’t run out the door to ask for help, because to leave the room without potentially taking the virus out, she had to sanitize her gloves, trash them, take her gown off, trash it, exit into an antechamber, take off her first layer of gloves, sanitize her hands and wipe down her face shield. So she ran to the window and banged on it, then ran back to her patient, trying to hold him down, her face inches from his.

Courage, to change the things I can, the prayer continued. Williams said it in the car that she drove to work and wouldn’t let any member of her family touch. Its speakers blared Lizzo-filled playlists she used to pump herself up for what she told her friends was an “awesome learning experience.” She had been a nurse for only two years. Her job in merchandising at Under Armour had brought her to Baltimore, where she met her husband, Sean, and his two children. They were the ones to make her realize that she wanted a job where she could actually see the impact of all those hours she worked. Now, every day might be the day she took the virus home to them.

Grant me the serenity to accept the things I cannot change, courage, to change the things I can, and wisdom to know the difference. Another day in Covidland, and Williams was wearing her new N95, pumping her palms into an unconscious man’s chest, not thinking of all the particles flying out of his airways. Another, and her face shield popped off and clattered to the floor. Another, and a young Latina mother told Williams she couldn’t self-quarantine because she could not afford to stay home from work.

Another, and Williams was watching the chest of a middle-aged man rise and fall by the force of a ventilator. Outside the walls of the hospital on this day in July, America seemed to have moved on from the conversation about the shortage of N95s. Instead, people were fighting over simple cloth masks.

Maybe this patient had worn one. Maybe he’d said he didn’t believe in them. Either way, it was her job to take care of him. Williams suctioned virus-filled fluid from his airways, and breathed in again.

‘Not profitable’

The radio advertisements could be heard across South Dakota, playing inside cars passing billboards plastered with the same message: 3M is hiring in Aberdeen. In a state that hosted 460,000 people at an August motorcycle rally and requires no one to wear a mask sits the largest respirator plant in the United States.

Its N95 manufacturing lines have been running 24 hours a day, 7 days a week since Jan. 21, the same day public health officials announced the arrival of the coronavirus in Washington state.

Plant manager Andy Rehder hired 200 new employees this year and was still looking for more this summer so he could staff another N95 line being built. Rehder, whose wife wears an N95 as a hospital social worker, had a Bloomberg Magazine article from March displayed in his office. The headline asked, “How do you make more masks yesterday?”

The question still hangs over the plant, and the entire country, nearly six months after that article was published.

Ask the Trump administration, and the N95 shortage is nearly solved. Rear Adm. John Polowczyk, whom Trump put in charge of securing PPE, said that by December, 160 million N95s will be made in the United States per month. By his calculations, that will be enough to handle a “peak surge” from hospitals, clinics, independent physicians, nursing homes, dentists and first responders. The Strategic National Stockpile has 60 million N95s on hand, and states are rebuilding their stockpiles.

“I’ve got production up to what we think is the limits of what we need,” Polowczyk said. “I believe now that hospital systems are making management decisions that might lead to an appearance that we still don’t have masks, which is the farthest from the truth.”

But ask the people inside hospitals, and the shortage is far from over. An August survey of 21,500 nurses showed 68 percent of them are required to reuse respirators, many for more than the five times recommended by the CDC, and some even more than Kelly Williams. One Texas nurse reported she’s still wearing the same five N95s she was given in March.

Many health-care facilities that ordered KN95s, Chinese-made masks meant to have a similar filtering efficiency, gave up on them after realizing that the looser fit left workers in danger. The N95 shortage is more acute for primary care physicians, home health aides and hospice workers. But even for many hospital systems, the situation remains “fragile and challenging,” the American Hospital Association said this month.

“Maddening, frustrating, mind-blowing, aggravating, that’s the polite language for it,” said American Medical Association President Susan Bailey, who still hears from doctors who do not have respirators. “There has been such an outpouring for support for ‘health-care heroes.’ Everybody knows now how important it is for our front-line health-care workers to be able to work in a safe environment. … And yet, that desire doesn’t seem to be turning into a reality.”

The AMA, AHA, American Nurses Association and the AFL-CIO all point to the same solution: broader use of the Defense Production Act, which gives the president power over funding for the production and distribution of critical supplies during crises.

In August, Trump stood before a group of socially distanced reporters, praising himself for using the DPA “more comprehensively than any president in history.”

“There was a time,” he said, “when the media would say, ‘Why aren’t you using it? Why aren’t you using it?’ Well, we have used it a lot, where necessary. Only where necessary.”

That’s not what it looks like to the man who used to run Trump’s DPA program within the Federal Emergency Management Agency. Larry Hall, who retired last year, said the authority has been executed in an “ad hoc, haphazard fashion.”

Along with ordering 3M to import 166.5 million masks from China, the administration has used the DPA to invest $296.9 million in bolstering the N95 and filter-making supply chains. The Department of Defense, which oversees that funding, spends more per year on instruments, uniforms and travel for military bands.

“By not having a national strategy,” Hall said, “we have fewer masks.”

Ask the PPE industry and the refrain is that without long-term guarantees that the government will keep buying respirators, N95 manufacturers are wary of investing too much, and other companies that could start making respirators or the filters for them are hesitant to do so.

Peter Tsai, the scientist who invented a method to charge the fibers inside the respirator filter, knows why: “It is not profitable to make respirators in the United States,” he said. It can take six months just to create one manufacturing line that makes the N95′s filter.

But there is a workaround, Tsai said. Companies that already make similar filters — for vehicle emissions, air pollution and water systems — can modify their equipment to make N95 filters.

While Tsai, 68, has been fielding hundreds of calls from hospitals and researchers trying to sanitize N95s with heat and ultraviolet light, he has been working with Oak Ridge National Laboratory in Tennessee to woo the 15 to 20 American companies that have the potential to produce respirator filters more quickly.

The government has funded just three of these companies through the DPA.

Others have gradually joined in on their own. But then those filters have to be made into respirators, and those respirators have to be approved by NIOSH, the National Institute for Occupational Safety and Health.

The entire process has moved at a glacial pace in comparison with the flurry of activity that rid the country of its ventilator shortage. Ventec, a company known for its efficient, toaster-size ventilators, handed its plans over to General Motors so that the auto company, under the DPA, could mass produce a product that was known to work. Other ventilator companies followed, handing over their trade secrets to Ford, Foxconn and other major manufacturers.

But when GM started making N95s, engineers with expertise in car interiors and air bags were charged with figuring out the process from scratch, the company said. Although they received advice from major mask makers, there were no groundbreaking corporate partnerships this time. The first N95s GM made were rejected by NIOSH. The second design didn’t correctly fit most people.

Other potential manufacturers went through the same challenges as GM, failing tests and making flat-fold N95s that experts worry do not offer a tight enough seal.

“If there was some kind of intellectual sharing, they wouldn’t be doing that,” said Christopher Coffey, who was the associate director for science in the NIOSH approvals program before retiring in January.

The DPA does have a provision that would allow manufacturers to work together without being subject to antitrust laws. But it has yet to be used for N95s.

Instead, established U.S. makers of N95s, whose products have been successfully protecting miners, construction workers and health-care professionals for decades, have continued to protect their processes as intellectual property.

Though 3M helped Ford make the far more expensive powered respirators, which blow clean air into a hood, the company has not entered into any major partnerships with outside manufacturers to make N95s. Asked why, 3M declined to explain, instead pointing to its other pandemic partnerships.

Ford gained its own approval to manufacture disposable respirators but has made just 16,000 of them while focusing instead on face shields and surgical masks. Other major U.S. manufacturers of N95s, including Honeywell and Moldex, have kept their manufacturing in-house, too.

“Folks aren’t likely to share that information outside of their own company,” said Jeff Peterson, who now oversees NIOSH approvals. NIOSH employees may know how 3M makes its respirators and the filters inside them. But by contract, they can’t tell other manufacturers how to do the same.

Meanwhile, 3M continues to dominate the American N95 market. While other parts of its business, such as office supplies and industrial adhesives, have struggled during the pandemic, 3M has invested $100 million to expand domestic production of respirators from 22 million to 50 million per month. Once the new production line is up and running in South Dakota in October, that number is expected to reach 95 million per month in the United States.

It still won’t be enough.

“Even though we are making more respirators than ever before and have dramatically increased production,” 3M spokeswoman Jennifer Ehrlich said, “the demand is more than we, and the entire industry, can supply for the foreseeable future.”

‘I just don’t get it’

Her N95 was already on, but Williams’s hands were slipping as she tried to force on a pair of gloves. She could hear the alarms going off. One of her patients was crashing, and she had to get into the room.

She should be able to just go, her runner’s legs carrying her to the bedside. But in Covidland, there were two closed doors standing in her way. She had started wearing her N95 all day so she could be ready for this moment. She pulled on her gown and another set of gloves and her face shield, reached for the door — and realized the patient inside was her 13-year-old stepson Kellen.

She jolted awake. She was in her bed. Her husband was asleep beside her. She slid out from her sheets and went downstairs to check on her stepchildren. Kellen and 19-year-old Alle were sleeping, too.

The nurse inhaled. She could still hear the alarms.

This is what it meant now, to be a health-care worker: across the country, nurses and doctors were reporting increased sleeplessness, anxiety, depression and post-traumatic stress.

Williams reminded herself that she’d always had an N95, and the heavier, more protective respirators she sometimes wore instead.

But she knew, too, that covid-19 had taken the lives of more than 1,000 health-care workers, including a New Jersey primary care doctor who, determined to keep his practice open, doubled up on surgical masks when his N95 orders didn’t come. And a California nurse who rushed into a covid patient’s room to perform chest compressions. She saved his life, then doused her hair in hand sanitizer. She hadn’t been given an N95 at the beginning of her shift.

And then there was the news that shook every health-care worker Williams knew: Less than two miles from Hopkins, the head of the ICU at Mercy Hospital died after contracting the virus in July.

Joseph Costa was one of the people who’d guided the hospital through its PPE shortage early in the pandemic. His husband, David Hart, remembered him coming home and saying, “This is my mask for the week.” Neighbors pushed N95s through their mailbox slot.

“This is the United States of America, and we can’t seem to get factories built to deliver this stuff? I just don’t get it,” Hart said.

He will never know exactly how his husband, who insisted on caring for covid patients alongside his staff, became infected. Costa died in the ICU, the gloved hands of his colleagues on him as he went. Minutes later, they returned to caring for other patients.

At Mercy, at Hopkins, at every hospital that had found a way to get N95s, health-care workers wore their PPE to try to save the lives of people who contracted the virus because they had none.

Williams and her colleagues didn’t need to see the statistics to know that the pandemic was disproportionately affecting Black and Brown people, especially those deemed essential workers. They saw it in their patients and heard it from their families and friends.

Williams worked side by side with Shanika Young, a nurse whose brother seemed to have every known covid-19 symptom before he started to recover.

Afraid of infecting anyone in her community, Young went weeks without seeing her parents and newborn niece. She adopted a hound-mix puppy to have a friend when she couldn’t see her own. In the weeks that followed the killing of George Floyd, she agonized over her decision to stay away from the protests. She knew there wouldn’t be N95s there.

On a sweltering August morning, she left her dog in her apartment and packed her respirator in her car. She, too, re-wore her mask, but usually for four or five 12-hours shifts.

Now Young was taking it across Baltimore, not toward the hospital, but to a predominantly Hispanic neighborhood with one of the worst infection rates in the city.

During the pandemic, Baltimore has seen outbreaks in its homeless shelters, its trash-collecting facility and its jail. Now every place Young drove by fell on one side or the other of a new dividing line in America: those who have PPE and those who don’t. Bodegas, restaurants, nail salons and funeral homes. Downtown, a nonprofit’s dental clinic remained shuttered. She passed a mental health counseling center where sessions were still conducted only by video, and a physical therapist who wore KN95s to see clients. She parked near a school that, without N95s, had no way of ensuring its teachers were protected. It serves primarily Latino children, all of whom would be forced to learn online.

In the parking lot of the church, a booth that used to sell $1 snow cones had been transformed into a coronavirus testing center run by a team of Hopkins doctors and nurses.

On her day off, Young volunteered to work with them, spending hours sweating in her scrubs, sending swabs deep into nose after nose. She wore a surgical mask on top of her N95.

“I don’t think there’s any science that says this is actually safer,” she said. “But it’s just a mental thing.”

The line of people sweating on the asphalt was so long, Young couldn’t see the people at the end: a man in painter’s clothes, a mother pushing a stroller and a woman who, like Young, was wearing scrubs. Stitched onto the chest was the name of a retirement home.

‘Hazard’

The coughing patient was starting to fall asleep when Williams left her in the covid unit. Her shift had been over for more than 30 minutes. She checked in to make sure there was no one else who needed her help and headed for the locker room. She washed her hands twice. She used alcohol wipes to sanitize her phone, glasses, ID badges and pens.

She took off her N95, and she inhaled.

For the first time in two months, she decided that this respirator was done. Its straps were starting to feel too stretched. The shape of it looked just a little too warped.

Instead of hanging the N95 from a hook in her locker to air dry, she stuffed it in a bag marked “hazard.”

A new mask, still in its plastic packaging, was waiting for her next shift. She would wear it as long as possible, especially after learning that the Hopkins stockpile had run out of the British-made mask she wore and couldn’t get any more. She needed to change to a different type of N95, one that felt unfamiliar once again. She told herself that she was grateful just to have it. She told herself that it would protect her just the same.

 

 

 

 

 

CMS kills controversial Medicaid fiscal accountability rule

https://www.healthcaredive.com/news/cms-kills-controversial-medicaid-fiscal-accountability-rule/585206/?utm_source=Sailthru&utm_medium=email&utm_campaign=Issue:%202020-09-15%20Healthcare%20Dive%20%5Bissue:29671%5D&utm_term=Healthcare%20Dive

What You Need to Know About the Medicaid Fiscal Accountability Rule (MFAR)  | KFF

Dive Brief:

  • CMS is axing its proposed Medicaid Fiscal Accountability Rule, agency head Seema Verma announced via Twitter late Monday afternoon, in a move quickly cheered by provider organizations.
  • The rule proposed last year would have increased federal oversight of how states fund their Medicaid programs and potentially resulted in funding cuts for the cash-strapped safety net insurance. Myriad providers, patient advocacy groups and lawmakers in both states and the halls of Congress opposed the rule as a result.
  • “We’ve listened closely to concerns that have been raised by our state and provider partners about potential unintended consequences of the proposed rule, which require further study. Therefore, CMS is withdrawing the rule from the regulatory agenda,” Verma said.

Dive Insight:

MFAR was designed to increase fiscal transparency in the 55-year-old Medicaid program, but was quickly met with a firestorm of controversy, with even bipartisan House and Senate members raising concerns it could lead to states being forced to choose between program cuts or raising taxes to replace the lost funding.

One estimate, conducted by Manatt Health for the American Hospital Association, estimated the changes proposed in the rule would cut Medicaid funding by almost $50 billion annually, shrinking the program by 8%.

“Hospitals and health systems will be greatly relieved when the proposed rule is formally withdrawn,” AHA EVP Tom Nickels said in a statement.

Bruce Siegel, CEO of America’s Essential Hospitals, a lobby representing hospitals serving a disproportionate amount of vulnerable patients, called CMS’ decision “wise and welcome … especially as state budgets and providers strain under the heavy financial burden and economic fallout of COVID-19.”

Medicaid is jointly funded by the states and the federal government. Generally, CMS matches every dollar states spend at rates that vary depending on the state, its covered services and its population. There are no limits for how much federal funding a state can receive, and snowballing spending in Medicaid has resulted in concerns about cost control.

Medicaid spending swelled from $456 billion in 2013 to $576 billion in 2016, per CMS data, mostly due to an expanding federal share.

The most acute worries on the federal side stemmed from supplemental payments, or payments state Medicaid agencies give to providers for going above and beyond routine care, normally for high-need patients or those in underserved areas.

Supplemental payments to healthcare providers have increased from 9.4% of all other payments in 2010 to 17.5% in 2017, according to CMS, and are generally uneven across state lines, contributing to geographic funding disparities.

Oversight agencies, including the Government Accountability Office and the Office of the Inspector General, flagged the growth in payments and called for stronger Medicaid oversight in a series of reports from 2006 to 2015.

As a result, CMS proposed the MFAR rule in November 2019. If finalized, it would require states to report Medicaid payment and financing data at the individual provider level, instead of an aggregate, and establish definitions for “base” and “supplemental” payments. It would also have allowed CMS to sunset existing supplemental payment methodologies after up to three years, requiring states to get approval for a longer period, and close financing loopholes that might allow states to re-use federal Medicaid dollars to fund additional payments.

At the outset, CMS attempted to stamp out criticisms the rule could winnow Medicaid funding. “Alarmist estimates that this rule, if finalized, will suddenly remove billions of dollars from the program and threaten beneficiary access are overblown and without credibility,” Verma wrote in a blog post on the proposal in February.

But the rule received more than 4,000 public comments, most of them negative. The swirling concerns about unintended consequences, especially as COVID-19 exacerbates worries about care access, have now brought CMS back to the drawing board on Medicaid fiscal accountability.

As of late Monday, MFAR remained on the Federal Register.

Other actions from the Trump administration to overhaul Medicaid have faced similar backlash, including unpopular efforts to instill requirements linking coverage to work hours and an early 2020 push to cap federal funding for states in exchange for wider latitude in program administration.

 

 

 

 

CMS to require positive COVID-19 test results for Medicare pay boost

https://www.beckershospitalreview.com/finance/cms-to-require-positive-covid-19-test-results-for-medicare-pay-boost.html?utm_medium=email

CMS to Pay For Hospital COVID-19 Care Furnished in Other Settings

CMS recently released guidance that includes a new requirement for hospitals to get a Medicare payment boost for caring for patients diagnosed with COVID-19. 

The Coronavirus Aid, Relief and Economic Security Act provided a 20 percent add-on payment to the inpatient prospective payment system diagnosis-related group rate for treating patients diagnosed with COVID-19. Until now, a physician’s documentation that a patient has COVID-19 was sufficient to receive the add-on payment. However, recent guidance from CMS adds the requirement to have a positive COVID-19 laboratory test documented in the patient’s medical record for the claim to be eligible for the add-on payment. The new requirement applies to admissions occurring on or after Sept. 1.

To receive the payment boost under the new guidance, the COVID-19 test must be taken within 14 days of the hospital admission. Only the results of viral testing that are consistent with CDC guidelines can be used. Tests performed by an entity other than the hospital, such as a local government-run testing center, can be manually entered into the patient’s medical record, CMS said.

Meeting the new requirement for the add-on payment could be difficult for hospitals, Ronald Hirsch, MD, vice president of the regulations and education group at R1 Physician Advisory Services, told Becker’s Hospital Review

“There is no way to indicate on a claim for a hospital patient that a test was positive or negative,” he said. “First, the hospital will manually need to go into every record for a patient with U07.1 as a diagnosis and look for a positive test in their own lab system. If one is not found, they will need to search the notes to see if the patient had a test in the 14 days prior to admission and if that test was positive. If there is a note the patient self-reported that they had a positive test, the hospital must decide if they must go through due diligence and attempt to get that actual test result for their records.”

In cases where there isn’t a positive test noted in the medical record, hospitals would need to notify the Medicare audit contractor that they are submitting a claim for a COVID-19 diagnosis that was made clinically, Dr. Hirsch said. The MAC would need to make the appropriate adjustment to ensure the 20 percent add-on payment is not made.

The “undue burden” that the new requirement will place on hospitals was one of the concerns the American Hospital Association highlighted in an Aug. 26 letter to CMS Administrator Seema Verma. The group is also concerned that requiring a positive COVID-19 test will lead to unnecessary additional testing.

“Basing the COVID-19 diagnosis code on clinical judgment alone — in line with coding rules — continues to be an important approach given that test accuracy may not be reliable, re-testing is unnecessarily onerous, and some communities face persistent testing shortages.” 

The AHA is urging CMS to drop the new requirement and allow provider documentation of a COVID-19 diagnosis to be sufficient for the add-on payment if the test result is unavailable. 

 

 

 

 

Administration delays final rule easing anti-kickback regs until next August

https://www.healthcaredive.com/news/trump-admin-delays-final-rule-easing-anti-kickback-regs-until-next-august/584158/?utm_source=Sailthru&utm_medium=email&utm_campaign=Issue:%202020-08-26%20Healthcare%20Dive%20%5Bissue:29307%5D&utm_term=Healthcare%20Dive

Dive Brief:

  • CMS has pushed back publishing a final rule that would ease anti-kickback regulations on providers by a year. The move is likely to anger healthcare organizations that have long clamored for the rule’s relaxation.
  • The deadline to finalize the rule proposed Oct. 17, 2019, is now Aug. 31, 2021. Originally, the rule relaxing stipulations of the decades-old Stark Law was expected this month. It’s unclear how the extension affects OIG’s tandem rule slacking similar regulations outlined in the Federal Anti-Kickback Statute and the Civil Monetary Penalties Law.
  • CMS chalked up the delay to the need to detangle the many thorny issues raised by healthcare companies in their comments on the rule. “We are still working through the complexity of the issues raised by comments received on the proposed rule and therefore we are not able to meet the announced publication target date,” Wilma Robinson, HHS deputy executive secretary, wrote in a notice on the change dated Monday. CMS did not respond to requests to clarify what issues are tying up the rule.

Dive Insight:

Hospital groups are unlikely to be pleased with the delay. The American Hospital Association earlier this month sent the Office of Management and Budget a letter urging them to expedite the review and release of the final Stark and AKS regulations.

“These rules take on even more significance in light of the COVID-19 pandemic,” AHA EVP Thomas Nickels wrote in the letter dated Aug. 19. “These rules will remove unnecessary regulatory burden from hospitals and health systems, allow for enhanced care coordination for patients, improve quality, and reduce waste in the Medicare and Medicaid programs.”

AHA did not respond to a request for comment by time of publication.

Healthcare organizations have said the Stark Law and Anti-Kickback Statute, passed decades ago in an attempt to deter physicians from referring patients to other locations or for services that would financially benefit them, are outdated and burdensome. Providers say the proposed changes are long overdue, citing longstanding concerns the laws hinder efforts to coordinate patient care across different sites and episodes.

The proposed rule, if finalized, would sharply ease federal anti-kickback regulations in a bid to help providers use value-based payment arrangements, reflecting the growing shift away from fee-for-service reimbursement and siloed care models.

The rule clarified exemptions from the physician self-referral law for certain value-based payment arrangements among physicians, providers and suppliers. Specifically, it applies to models with a specific patient population, where one of the entities takes on full financial risk for providing Medicare Part A and Part B for the first six months. The payments can either be capitated or global.

Doctors would be required to pay back a fourth of payments if they don’t meet financial goals.

The proposed rule also introduced a new exemption for certain arrangements under which a doctor receives limited payment for items and services that he or she provides, and another that would allow hospitals and medical device manufacturers to donate cybersecurity tools and other related software to doctors without fear of retribution.

Comments on the proposed rule from the hospital and physician community were generally supportive of the changes, though some organizations, including the American Hospital Association and Walmart, thought the feds didn’t go far enough. Hospital groups argued the exceptions should be expanded to include private payers, along with Medicare and Medicaid and the definition of value-based arrangements should be broadened, along with some other clarifications.

Per the Social Security Act, agencies have to maintain a regular timeline for publishing final regulations, normally within three years of the draft. However, they are allowed to extend the original deadline, if they justify the change.

 

 

 

 

Revenues and volumes have fallen ‘off a cliff’ hospital executives tell American Hospital Association

https://www.healthcarefinancenews.com/news/aha-releases-case-studies-us-hospitals-and-health-systems-highlighting-financial-challenges

Revenues and volumes have fallen 'off a cliff' hospital executives ...

Eight health systems in AHA case study are asking Congress for more relief funding.

The American Hospital Association has released eight case studies from hospitals and health systems across the country that highlight how systems of different shapes and sizes are reacting to the financial challenges posed by COVID-19.

The case studies include Kindred Healthcare and TIRR Memorial Hermann in Houston; AdventHealth Central Florida Division in Orlando, Florida; the Loretto Hospital in Chicago; Kittitas Valley Healthcare in Ellensburg, Washington; Washington Regional Medical Center in Fayetteville, Arkansas; Banner Health in Phoenix; UR Medicine Thompson Health in Canandaigua, New York; and the Queen’s Health Systems and the Queen’s Medical Center in Honolulu.

Across the board, every case study revealed that hospitals and health systems are asking Congress for more relief funding.

“We are begging for more assistance and more help because we can’t keep moving forward,” said Michael Stapleton, the president and CEO of UR Medicine Thompson Health in New York.

WHAT’S THE IMPACT?

In Texas, the state with the third most COVID-19 cases, Kindred Healthcare and TIRR Memorial Hermann have begun to rely on inpatient rehabilitation facilities and long-term acute care hospitals to treat COVID-19-positive and medically complex recovering COVID-19 patients.

“In particular, as communities and hospitals struggled to meet ICU capacity needs, these hospitals stepped forward to take care of COVID-19-positive patients and others to help provide beds for more COVID-19-positive patients,” the case study said.

However, even with assistance from local facilities, post-acute care providers have incurred increased costs to prepare for and treat COVID-19-positive patients and complex post-COVID-19 patients.

“When you look at lost revenue and volumes, and the additional costs of ramping up to prepare for COVID-19, whether it’s personal protective equipment, respiratory systems, medications or facility infrastructure changes, there are significant dollars associated with that,” said Jerry Ashworth, the senior vice president and CEO at TIRR Memorial Hermann.

AdventHealth in Florida has taken financial hits from declining elective procedures and purchasing personal protective equipment. The company says it has lost $263 million since the start of the pandemic and has spent $254 million sourcing PPE.

“Florida is in the middle of the crisis,” said Todd Goodman, division chief financial officer of AdventHealth. “Our current COVID numbers are four times higher than the peak that we had back in April. We are bringing in higher-priced nurses and staff from other parts of the nation, because of a rapid increase in inpatient census. We are in a different place today than we were even six weeks ago.”

COVID-19 has disproportionately affected communities of color across the country, but especially in Chicago, where 30% of the population is Black. Forty-six percent of all COVID-19 cases and 57% of all deaths are Black people.

Despite having 70% of its admissions being related to COVID-19, the Loretto Hospital in Chicago has not received any funds from the Coronavirus Aid, Relief, and Economic Security Act hot spot distribution.

“Our COVID-19 unit is full and has been for the last three months; we’re now at 296 COVID-19 patients [on July 16] and yet we’ve not received any of the COVID-19 high impact ‘hot spot’ payments,” said George Miller, the president and CEO of the Loretto Hospital. “We got the Small Business Administration loan to help keep our team members employed.”

Kittitas Valley Healthcare in Washington was among the first in the country to feel the impact of COVID-19. The rural delivery system and its critical access hospital postponed elective surgeries and many other nonessential services in response.

“Our revenues and volumes fell off a cliff,” said Julie Petersen, the CEO of Kittitas Valley Healthcare. “Our orthopedics programs, our GI [gastrointestinal] programs and cataract surgeries evaporated.”

Now, the hospital is off its original 2020 net revenue projections by $8.4 million.

After seeing a 12% rise in COVID-19 cases over a two-week period in Fayetteville, Arkansas, the Washington Regional Medical Center had 96% of its 40 intensive care unit beds occupied, a 20-bed COVID-19 ICU was completely full, and 298 of the facility’s 315 adult beds were occupied.

Taking care of these patients put the health system in a financial crisis. Its net patient revenue declined by $14 million in April. It furloughed 350 of its 3,300 employees and reduced the hours of 360 full-time workers, according to Larry Shackelford, the president and CEO of Washington Regional Medical Center.

On July 12, Banner Health in Arizona had more than 1,500 inpatients who either tested COVID-positive or are suspected of having COVID-19, representing 45% of the COVID-19 inpatient hospitalizations in the state, according to Dr. Marjorie Bessel, the chief clinical officer at Banner Health.

Banner expects operating losses of $500 million for 2020, compared to its initial expectations, with expected revenue losses approaching $1 billion for the year, according to the case study.

By mid-March, New York had 15 times more COVID-19 cases than any other state, according to the case study. Like the rest of the state, UR Medicine Thompson Health shut down many of its services, resulting in “insurmountable” financial losses and staff furloughs.

“Our first projection was a $17 million loss through the year-end,” Stapleton said. “We lost half of March, all of April and half of May. The hospital has received only $3.1 million from the CARES Act tranche payments.”

Although the Queen’s Health Systems and the Queen’s Medical Center in Hawaii are starting to reschedule appointments, surgeries and procedures that had been delayed by COVID-19, patients aren’t coming back as anticipated.

Even with the pent-up demand for elective procedures, minimally invasive and even short-stay procedures are still down by about 18%. We are seeing our in-person clinic visits down by about 14%, and the emergency department (ED) is the one that surprised us the most – down by 38%,” said Jason Chang, president of the Queen’s Medical Center and chief operating officer of the Queen’s Health Systems and the Queen’s Medical Center.

The systems lost $127 million between March and May, according to Chang. He says the projected losses are about $60 million for 2021, but could reach $300 million if Hawaii experiences a second wave of COVID-19.

THE LARGER TREND

The AHA has cited $323 billion in losses industry-wide due to the ongoing COVID-19 pandemic, with U.S. hospitals anticipating about $120 billion in losses from July to December alone.

It was joined by the American Nurses Association and the American Medical Association to ask Congress to provide additional funding to the original $100 billion from the CARES Act. In a letter sent in July, the organizations asked for “at least an additional $100 billion to the emergency relief fund to provide direct funding to front line health care personnel and providers, including nurses, doctors, hospitals and health systems, to continue to respond to this pandemic.”

 

 

 

 

Drug payment cuts to 340B hospitals spur debate on best path forward

https://www.healthcarefinancenews.com/news/drug-payment-cuts-340b-hospitals-spur-debate-best-path-forward

340B hospitals breathing easier under Dem-controlled House

Hospitals say revenue from the 340B program is essential, while others contend the original law is being abused.

On August 3, an federal appeals court ruled that 340B hospitals will now be subject to Medicare cuts in outpatient drug payments by nearly 30%, reversing an earlier ruling calling those cuts illegal. The 2-1 decision by the U.S Court of Appeals for the District of Columbia Circuit essentially gives the Trump Administration and the Department of Health and Human Services the legal authority to reduce payment for Medicare Part B drugs to 340B hospitals.

HHS Secretary Alex Azar said the action means patients – particularly those who live in vulnerable areas – will pay less out-of-pocket for drugs in the Medicare Part B program. But providers, including the American Hospital Association, the Association of American Medical Colleges and America’s Essential Hospitals, said the 340B decision will hurt hospitals and patients in these vulnerable areas.

Hospitals that serve large numbers of Medicaid, Medicare and uninsured patients were getting the drugs for a discounted price, but, getting reimbursed at the higher price, HHS pays all hospitals for Medicare Part B drugs. The hospitals, many of which are in the red or operating on thin margins, were using the pay gap in the price difference to cover operational expenses. HHS deemed it inappropriate that these facilities would use Medicare to subsidize other activities and initiatives, and the appeals court agreed.

As per the original 340B legislation, discounts on drugs can range from 13% to 32% off the average retail price for participating providers, but Medicare Part D sets reimbursement in an entirely different way, leading to the significant reimbursement discrepancies – until the ruling, which furthered HHS’ push to narrow the spread between acquisition price and reimbursement.

THE DEBATE

“The opportunity to exploit this buy/sell differential probably has something to do with the explosive growth there’s been in the number of participating institutions in 340B,” said Michael Abrams, cofounder and managing partner of Numerof and Associates. “According to the data I came across, discounted 340B purchases grew 23% from 2018 to 2019, and currently make up about 8% of the total of the U.S. drug market. So from my perspective this looks like a loophole that’s been used by a small number of large institutions, who in many cases don’t serve that many disadvantaged patients, but nonetheless serve enough to qualify for the 340B program and to purchase the drugs they buy at the discounted rate.”

Groups representing U.S. hospitals would disagree with that assessment, and, in fact, when the appeals court handed its ruling, the AHA, AAMC and America’s Essential Hospitals said 340B hospitals and their patients would “suffer lasting consequences.”

“The decision conflicts with Congress’ clear intent and defers to the government’s inaccurate interpretation of the law, a point that was articulated by the judge who dissented from the opinion,” the groups wrote in a statement. “For more than 25 years, the 340B program has helped hospitals stretch scarce federal resources to reach more patients and provide more comprehensive services. Hospitals that rely on the savings from the 340B drug pricing program are also on the front-lines of the COVID-19 pandemic, and today’s decision will result in the continued loss of resources at the worst possible time.”

President and CEO of 340B Health Maureen Testoni also lamented the appeals court’s decision, calling the cuts “discriminatory.”

“These cuts of nearly 30% have caused real and lasting pain to safety-net hospitals and the patients they serve,” she said earlier this month. “Keeping these cuts in place will only deepen the damage of forced cutbacks in patient services and cancellations of planned care expansions. These effects will be especially detrimental during a global pandemic.

Abrams contends that much of the confusion and legal wrangling can be attributed to the vagueness of the original 340B legislation, the stated goal of which was to “enable participating institutions to stretch scarce financial dollars.” With little else to go on in terms of the language, those on each side of the issue were able to interpret it in their own way, with participating institutions saying it’s within the bounds of the law to use that revenue stream to enhance their mission – another phrase that’s open to wide interpretation.

“There’s no question this is being put to uses that were never intended,” said Abrams, adding that the profits generated by the buy/sell differential often disappear into balance sheets with little to no accountability.

Hospitals, for their part, feel they’re under siege by HHS at a critical time for the healthcare system’s financial viability. Even before the COVID-19 pandemic, hospitals saw the migration of lucrative inpatient procedures, such as hip and knee replacements, to freestanding outpatient facilities, which in some cases are not owned by the hospital. That represents a significant loss of revenue. Factor in the lost revenue from cancelled or delayed elective procedures due to the coronavirus, as well as patients who are too cautious to enter the healthcare system, and hospitals are hurting. AHA President and CEO Rick Pollack said in July that half of all U.S. hospitals will likely be in the red by the end of the year.

A COMPLICATED PICTURE

Actions by the pharmaceutical industry are also adding to the complication. A recent statement from America’s Essential Hospitals alleges that recent actions by pharmaceutical manufacturers “hinder access to affordable medications for millions of people who face financial hardships and defy clear statutory requirements that they provide drugs to 340B Drug Pricing Program covered entities.”

The manufacturers have threatened punitive actions – including withholding 340B drugs to contract pharmacies – for failing to comply with reporting requirements that Essential Hospitals call “arbitrary.”

“These data requests have no clear link to program integrity,” the group said. “Rather, they seem to be little more than a fishing expedition.”

A concrete example can be found in AstraZeneca’s decision to refuse 340B pricing to hospitals with on-site pharmacies for any drugs that will be dispensed through contract pharmacies. In a statement this week, Testoni of 340B called this action an “attack” on the 340B program that will hurt healthcare institutions as well as low-income and rural Americans.

“We believe that refusing to offer discounts that the 340B statute requires is a violation of federal law,” said Testoni. “We are calling on Health and Human Services Secretary (Alex) Azar to exercise his authority to stop these overcharges before they cause permanent damage to the healthcare safety net.”

Abrams sides more with the appeals court decision, saying that requiring the pharmaceutical industry to sell drugs at a discount comes with significant regulation to ensure they do so – a stark contrast to the lack of regulation around the resulting revenue. Though another appeal certainly isn’t out of the question, Abrams expects participation in the program to shrink back to a level reflecting the size of the target populations.

“This is about helping disadvantaged patients get their drugs, and that should be the driving activity of the program,” he said. “I’m fine with HHS taking this problem on, because it was an abuse that was never intended in the original legislation. It just seems to me that HHS really wants the healthcare sector to deliver care that is more accountable both for efficient use of resources and outcomes.”

One person who disagrees is Circuit Judge Cornelia Pillard, who wrote the dissenting opinion in the appeals court decision.

“The challenged rules took a major bite out of 340B hospitals’ funding,” she said. “Often operating at substantial losses, 340B hospitals rely on the revenue that Medicare Part B provides in the form of standard drug-reimbursement payments that exceed those hospitals’ acquisition costs. 340B hospitals have used the additional resources to provide critical healthcare services to communities with underserved populations that could not otherwise afford these services.”

 

 

 

 

Cash-Pinched Hospitals Press Congress to Break Virus Fund Logjam

https://news.bloomberglaw.com/health-law-and-business/cash-pinched-hospitals-press-congress-to-break-virus-fund-logjam

DIY Money Tree Gift Idea - So TIPical Me

Hospital groups are pressing Congress to put more money into a relief fund for hospitals and providers, even as labor data showed signs of a turnaround for the health-care industry last month.

Congressional leaders are at a standstill over the next coronavirus-relief package and it could be weeks until lawmakers vote on legislation. Hospital groups have said the $175 billion Congress already approved has been a crucial lifeline to keep hospitals from laying off more staff or potentially closing. Some are worried the money may start to run dry soon.

The coronavirus is prompting many Americans to delay health care, and further funding delays exacerbate the need for assistance, the hospitals warn. Some providers that shed jobs earlier in the pandemic have begun adding them back, but employment levels remain far below where they once were.

“The longer we are in the pandemic the more clear it becomes that this is not going to be a short-term issue,” Beth Feldpush, senior vice president of policy and advocacy at America’s Essential Hospitals, said.

Leaders of both parties back more federal funding to help hospitals and doctors’ offices stay in business. Democrats proposed $100 billion for the industry, as hospital groups such as AEH sought, in virus-relief legislation (H.R. 6800) the House passed earlier this year. Republicans included $25 billion in their counterproposal.

The Health and Human Services Department has promised about $115 billion of the $175 billion in relief Congress approved this year to help health-care providers offset their Covid-19-related losses, according to agency data. That leaves the industry with about $60 billion left.

The U.S. exceeded 5 million confirmed Covid-19 cases Aug. 9, according to data from Bloomberg News and Johns Hopkins University, more than any other country. Almost 165,000 people in the U.S. have died from the virus.

Industry Impact

The health-care industry added more than 126,000 jobs in July, according to data released last week by the Bureau of Labor Statistics. Dentist offices and hospitals, the section of the industry that was laying off tens of thousands of people in April and May, accounted for more than 70,000 of those new jobs.

Still, there were 797,000 fewer health-care jobs compared to before the pandemic, according to BLS.

The virus hit parts of the heath-care industry unevenly. Large health systems such as HCA Healthcare Inc. and Universal Health Services Inc. posted better-than-expected profits for the second quarter of 2020.

Some hospitals that didn’t have much cash-on-hand to start the year are struggling with lower profits and may need added relief if the virus continues to keep Americans from seeking care, industry watchers said.

“No hospital is going to come out of this year better than they were in prior years,” Suzie Desai, senior director for S&P Global Rating’s Not-for-Profit Health Care group, said.

The federal relief funds helped buoy hospitals this year, hospital groups argue. The American Hospital Association estimates that without relief funds, hospitals margins would have been down 15% and could be down 11% at the end of 2020 if the virus continues to spread at its current pace.

The AHA estimated losses for the nation’s hospitals and health systems will reach $323 billion this year.

 

 

Industry Voices—6 ways the pandemic will remake health systems

https://www.fiercehealthcare.com/hospitals/industry-voices-6-ways-pandemic-will-remake-health-systems?mkt_tok=eyJpIjoiTURoaU9HTTRZMkV3TlRReSIsInQiOiJwcCtIb3VSd1ppXC9XT21XZCtoVUd4ekVqSytvK1wvNXgyQk9tMVwvYXcyNkFHXC9BRko2c1NQRHdXK1Z5UXVGbVpsTG5TYml5Z1FlTVJuZERqSEtEcFhrd0hpV1Y2Y0sxZFNBMXJDRkVnU1hmbHpQT0pXckwzRVZ4SUVWMGZsQlpzVkcifQ%3D%3D&mrkid=959610

Industry Voices—6 ways the pandemic will remake health systems ...

Provider executives already know America’s hospitals and health systems are seeing rapidly deteriorating finances as a result of the coronavirus pandemic. They’re just not yet sure of the extent of the damage.

By the end of June, COVID-19 will have delivered an estimated $200 billion blow to these institutions with the bulk of losses stemming from cancelled elective and nonelective surgeries, according to the American Hospital Association

A recent Healthcare Financial Management Association (HFMA)/Guidehouse COVID-19 survey suggests these patient volumes will be slow to return, with half of provider executive respondents anticipating it will take through the end of the year or longer to return to pre-COVID levels. Moreover, one-in-three provider executives expect to close the year with revenues at 15 percent or more below pre-pandemic levels. One-in-five of them believe those decreases will soar to 30 percent or beyond. 

Available cash is also in short supply. A Guidehouse analysis of 350 hospitals nationwide found that cash on hand is projected to drop by 50 days on average by the end of the year — a 26% plunge — assuming that hospitals must repay accelerated and/or advanced Medicare payments.

While the government is providing much needed aid, just 11% of the COVID survey respondents expect emergency funding to cover their COVID-related costs.

The figures illustrate how the virus has hurled American medicine into unparalleled volatility. No one knows how long patients will continue to avoid getting elective care, or how state restrictions and climbing unemployment will affect their decision making once they have the option.

All of which leaves one thing for certain: Healthcare’s delivery, operations, and competitive dynamics are poised to undergo a fundamental and likely sustained transformation. 

Here are six changes coming sooner rather than later.

 

1. Payer-provider complexity on the rise; patients will struggle.

The pandemic has been a painful reminder that margins are driven by elective services. While insurers show strong earnings — with some offering rebates due to lower reimbursements — the same cannot be said for patients. As businesses struggle, insured patients will labor under higher deductibles, leaving them reluctant to embrace elective procedures. Such reluctance will be further exacerbated by the resurgence of case prevalence, government responses, reopening rollbacks, and inconsistencies in how the newly uninsured receive coverage.

Furthermore, the upholding of the hospital price transparency ruling will add additional scrutiny and significance for how services are priced and where providers are able to make positive margins. The end result: The payer-provider relationship is about to get even more complicated. 

 

2. Best-in-class technology will be a necessity, not a luxury. 

COVID has been a boon for telehealth and digital health usage and investments. Two-thirds of survey respondents anticipate using telehealth five times more than they did pre-pandemic. Yet, only one-third believe their organizations are fully equipped to handle the hike.

If healthcare is to meet the shift from in-person appointments to video, it will require rapid investment in things like speech recognition software, patient information pop-up screens, increased automation, and infrastructure to smooth workflows.

Historically, digital technology was viewed as a disruption that increased costs but didn’t always make life easier for providers. Now, caregiver technologies are focused on just that.

The new necessities of the digital world will require investments that are patient-centered and improve access and ease of use, all the while giving providers the platform to better engage, manage, and deliver quality care.

After all, the competition at the door already holds a distinct technological advantage.

 

3. The tech giants are coming.

Some of America’s biggest companies are indicating they believe they can offer more convenient, more affordable care than traditional payers and providers. 

Begin with Amazon, which has launched clinics for its Seattle employees, created the PillPack online pharmacy, and is entering the insurance market with Haven Healthcare, a partnership that includes Berkshire Hathaway and JPMorgan Chase. Walmart, which already operates pharmacies and retail clinics, is now opening Walmart Health Centers, and just recently announced it is getting into the Medicare Advantage business.

Meanwhile, Walgreens has announced it is partnering with VillageMD to provide primary care within its stores.

The intent of these organizations clear: Large employees see real business opportunities, which represents new competition to the traditional provider models.

It isn’t just the magnitude of these companies that poses a threat. They also have much more experience in providing integrated, digitally advanced services. 

 

4. Work locations changes mean construction cost reductions. 

If there’s one thing COVID has taught American industry – and healthcare in particular – it’s the importance of being nimble.

Many back-office corporate functions have moved to a virtual environment as a result of the pandemic, leaving executives wondering whether they need as much real estate. According to the survey, just one-in-five executives expect to return to the same onsite work arrangements they had before the pandemic. 

Not surprisingly, capital expenditures, including new and existing construction, leads the list of targets for cost reductions.

Such savings will be critical now that investment income can no longer be relied upon to sustain organizations — or even buy a little time. Though previous disruptions spawned only marginal change, the unprecedented nature of COVID will lead to some uncomfortable decisions, including the need for a quicker return on investments. 

 

5. Consolidation is coming.

Consolidation can be interpreted as a negative concept, particularly as healthcare is mostly delivered at a local level. But the pandemic has only magnified the differences between the “resilients” and the “non-resilients.” 

All will be focused on rebuilding patient volume, reducing expenses, and addressing new payment models within a tumultuous economy. Yet with near-term cash pressures and liquidity concerns varying by system, the winners and losers will quickly emerge. Those with at least a 6% to 8% operating margin to innovate with delivery and reimagine healthcare post-COVID will be the strongest. Those who face an eroding financial position and market share will struggle to stay independent..

 

6. Policy will get more thoughtful and data-driven.

The initial coronavirus outbreak and ensuing responses by both the private and public sectors created negative economic repercussions in an accelerated timeframe. A major component of that response was the mandated suspension of elective procedures.

While essential, the impact on states’ economies, people’s health, and the employment market have been severe. For example, many states are currently facing inverse financial pressures with the combination of reductions in tax revenue and the expansion of Medicaid due to increases in unemployment. What’s more, providers will be subject to the ongoing reckonings of outbreak volatility, underscoring the importance of agile policy that engages stakeholders at all levels.

As states have implemented reopening plans, public leaders agree that alternative responses must be developed. Policymakers are in search of more thoughtful, data-driven approaches, which will likely require coordination with health system leaders to develop flexible preparation plans that facilitate scalable responses. The coordination will be difficult, yet necessary to implement resource and operational responses that keeps healthcare open and functioning while managing various levels of COVID outbreaks, as well as future pandemics.

Healthcare has largely been insulated from previous economic disruptions, with capital spending more acutely affected than operations. But the COVID-19 pandemic will very likely be different. Through the pandemic, providers are facing a long-term decrease in commercial payment, coupled with a need to boost caregiver- and consumer-facing engagement, all during a significant economic downturn.

While situations may differ by market, it’s clear that the pre-pandemic status quo won’t work for most hospitals or health systems.