America’s most prestigious medical journal makes a political statement

https://mailchi.mp/45f15de483b9/the-weekly-gist-october-9-2020?e=d1e747d2d8

In Rare Step, Esteemed Medical Journal Urges Voters To Oust Trump | KPCW

For its first 208 years, the New England Journal of Medicine has never endorsed a political candidate. But this week the journal published an editorial outlining its political position in the upcoming Presidential election, signed unanimously by all editors who are US citizens.

The editors did not explicitly endorse former Vice President Biden, but rather offered a scathing condemnation of the current administration’s performance during the COVID pandemic: “Reasonable people will certainly disagree about the many political positions taken by candidates.

But truth is neither liberal nor conservative. When it comes to the response to the largest public health crisis of our time, our current political leaders have demonstrated that they are dangerously incompetent. We should not abet them and enable the deaths of thousands more Americans by allowing them to keep their jobs.” (Formally endorsing Biden last month, Scientific American also made the first political endorsement in its 175-year history.)
 
Much of the media coverage of the NEJM statement has centered on the question of whether medicine should involve itself in politics, or “live above it”

Medicine has been drawn into political disputes before, but now the nature of the involvement has changed. In the past, debates largely centered around regulation, payment or policy—but now the science itself has become a fundamentally political issue. 

The very nature of the coronavirus has become a matter of political belief, not just an indisputable scientific fact.

Public trust in both scientific institutions and the government, and their ability to work together, has been damaged. We fear this will lead to poorer health outcomes regardless of who wins the upcoming election.

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.

CommonSpirit Health posts $550M operating revenue loss in fiscal year due to COVID-19

A financial chart

Hospital system CommonSpirit Health reported operating revenue losses of $550 million during its fiscal year that ended in June, as the COVID-19 pandemic continues to roil patient volumes.

The 137-hospital system reported its financial earnings Friday for the 2020 fiscal year that ended June 30. CommonSpirit’s expenses also surged during the pandemic as more resources were needed to screen visitors and staff.

“Although it varies significantly by division, beginning the middle of March, the COVID-19 pandemic caused up to a 40% slowdown in volumes,” CommonSpirit’s financial report said. “As communities heeded guidelines to avoid hospitals for non-emergent issues, appointment volume, especially for specialty practices, fell and emergency department volume declined.”

CommonSpirit’s patient volumes did rebound after shelter-in-place orders started to be lifted in April and May, but the volumes are still below pre-pandemic levels.

At the end of the system’s fiscal year on June 30, the volumes on adjusted admissions were down 6.2% compared with the 2019 fiscal year.

Adjusted patient days for the fiscal year were also lower than the same period in 2019 by 5.7%.

At the same time, net patient and premium revenues declined by $239 million, or 0.9% over the same period in 2019.

“The decrease is primarily due to the impact of the COVID-19 pandemic and increased charity care, partially offset by a stable payor mix,” the earnings said.

Overall, CommonSpirit recorded an operating loss of $550 million for the 2020 fiscal year, which was an improvement on the $617 million in losses from 2019.

But those 2020 losses ballooned up to $1.4 billion when not taking into account money the system received from a $175 billion provider relief fund Congress set up as part of the CARES Act to help prop up hospitals and other providers.

The system also reported a $1.3 billion decline in earnings before interest, tax, depreciation and amortization and nonoperating income from March through June.

About 62% of the lost EBITDA has been recouped through the CARES Act funding, and another $500 million remains to be regained, CommonSpirit said.

Overall, CommonSpirit has recorded $826 million in money from the provider relief fund. It also got another $2.6 billion from the Medicare Accelerated and Advance Payment Program, which the system will have to repay.

The system anticipates it will defer $410 million in employer payroll taxes to December 2022, a flexibility also afforded under the CARES Act.

“While the aid received from the programs above provides much needed assistance during this crisis, CommonSpirit is unable to assess the extent to which the amounts and benefits received, or to be received, will offset the long-term changes in volumes, payor mix or service mix,” the report said.

The Department of Health and Human Services has more than $50 billion to still give out to hospitals, but some hospital groups say that more money is needed to combat the financial crisis caused by the pandemic. Talks on a new coronavirus relief deal have stalled in Congress.

While some larger for-profit systems such as HCA and Tenet have posted profits thanks to the provider relief funding, other not-for-profit systems such as Trinity Health and some smaller systems have reported struggles with overcoming the new financial crisis.

$6B fraud bust includes numerous telehealth schemes

https://www.healthcaredive.com/news/6b-fraud-bust-includes-numerous-telehealth-schemes/586220/?utm_source=Sailthru&utm_medium=email&utm_campaign=Issue:%202020-10-01%20Healthcare%20Dive%20%5Bissue:29992%5D&utm_term=Healthcare%20Dive

Dive Brief:

  • Federal agencies have charged 345 people across the country, including more than 100 providers and four telehealth executives, with submitting more than $6 billion in fraudulent claims to payers. Of that, $4.5 billion was connected to telemedicine schemes and about $800 million each to substance abuse treatment and illegal opioid distribution.
  • More than 250 medical professionals had their federal healthcare billing privileges revoked for being involved in the scams, according to a statement released Wednesday.
  • The U.S. Department of Justice also said it is creating a new rapid response strike force to investigate fraud cases involving major providers that operate in multiple jurisdictions.

Dive Insight:

Telehealth fraud has increased significantly since 2016, the HHS Office of Inspector General said. As providers have quickly pivoted many services to virtual care during the COVID-19 pandemic, attempts at fraud will likely follow.

One of the cases outlined Wednesday included false claims for COVID-19 testing while another involved a COVID-19 related scheme to defraud insurers out of more than $4 million.

The telehealth fraud allegedly involved a marketing network that lured hundreds of thousands of people into a criminal scheme with phone calls, direct mail, TV ads and online pop-up ads. Telemedicine executives then paid doctors to order unneeded medical equipment, testing or drugs with either no patient interaction or only a brief call. 

Those were either not given to the patients or were worthless to them. The proceeds were then laundered through international shell corporations and banks.

The scheme is similar to one DOJ prosecuted in April 2019 involving fraudulent telehealth companies that pushed unneeded braces on Medicare beneficiaries in exchange for kickbacks from durable medical equipment companies.

The massive bust included the work of 175 HHS OIG agents and analysts and targeted myriad fraud operations across the U.S. and its territories.

One of the larger scams involved 29 defendants in the Middle District of Florida. A telemedicine company and medical professionals working for it billed Medicare for medical equipment for patients they never spoke to.

In New Jersey, laboratory owners paid marketers to get DNA samples at places like senior health fairs. Doctors on telemedicine platforms then ordered medically unnecessary and not reimbursable genetic testing.

 

 

 

 

Administration Sketches Healthcare Plan, Signs Executive Order

https://www.medpagetoday.com/washington-watch/electioncoverage/88810?xid=fb_o&trw=no&fbclid=IwAR1OTD2FHXYsDzbKZ_H3MdTUNnvlxhe7kqEMtaZMXjRBpkHFksvvY-lHVGc

New Executive Order Applies to Foreign Third-Party Code | The Media Trust

Critics question value of provision addressing preexisting condition coverage.

President Trump presented his “America First Healthcare Plan” during a speech to healthcare professionals in Charlotte, North Carolina, on Thursday — a plan that mentioned preexisting condition coverage protections and surprise billing but did not seem to include comprehensive changes to the healthcare system.

“Under the America First Healthcare Plan, we will ensure the highest standard of care anywhere in the world, cutting-edge treatments, state-of-the-art medicine, groundbreaking cures, and true health security for you and your loved ones,” Trump said. “And we will do it rapidly, and it’s in very good order, and some of it has already been implemented.”

Executive Order Provisions

The president signed an executive order outlining the plan, but the order contained initiatives in only a few areas, including:

  • Preexisting condition coverage. The order says simply: “It has been and will continue to be the policy of the United States to ensure that Americans with preexisting conditions can obtain the insurance of their choice at affordable rates.” The order does not direct any government agency to enact a regulation nor request Congress to pass legislation. In August 2018, the Trump administration allowed the sale of “short-term, limited duration” insurance plans that could last for up to 3 years; these often exclude coverage for preexisting conditions but also typically cost less than comprehensive coverage.
  • Surprise billing. “Recognizing that both chambers of the Congress have made substantial progress towards a solution to end surprise billing, the Secretary of Health and Human Services (HHS) shall work with the Congress to reach a legislative solution by December 31, 2020,” the order says. “In the event a legislative solution is not reached by December 31, 2020, the Secretary of Health and Human Services shall take administrative action to prevent a patient from receiving a bill for out-of-pocket expenses that the patient could not have reasonably foreseen.”
  • Price transparency. “Within 180 days of the date of this order, the Secretary of Health and Human Services shall update the Medicare.gov Hospital Compare website to inform beneficiaries of hospital billing quality, including whether the hospital is in compliance with the Hospital Price Transparency Final Rule whether, upon discharge, the hospital provides patients with a receipt that includes a list of itemized services received during a hospital stay; and how often the hospital pursues legal action against patients, including to garnish wages, to place a lien on a patient’s home, or to withdraw money from a patient’s income tax refund,” the order reads.

Trump also announced another initiative, this one aimed at seniors. “Under my plan, 33 million Medicare beneficiaries will soon receive a card in the mail containing $200 that they can use to help pay for prescription drugs … The cards will be mailed out in coming weeks,” Trump said. The $6.6 billion cost of the cards will be paid for under the auspices of a Medicare demonstration program. These funds are ostensibly available via savings generated through Trump’s “most favored nation” executive order allowing Medicare to pay no more for certain prescription drugs than the price paid by other developed countries, a White House official said. That executive order has not yet been implemented, however, and court challenges are expected.

Final Rule Issued on Drug Importation

Trump also noted that the FDA issued a final rule on Thursday implementing the president’s July executive order earlier this month to allow for importation of certain less expensive prescription drugs from Canada. “This means a state or whatever — can go to Canada and buy drugs for a fraction of the price that they’re charging right now,” he said.

He also highlighted individual actions his administration had taken that mostly affected particular groups, including lowering insulin prices for certain Medicare beneficiaries, investing in childhood cancer research, and expanding health reimbursement accounts that employers can use to reimburse employees for medical expenses. The COVID-19 pandemic received scant mention other than a reference to slashing red tape to accelerate development of treatments for the disease, and a sentence about how the pandemic had greatly increased the use of telehealth.

During a telephone briefing with reporters Thursday afternoon, HHS Secretary Alex Azar highlighted the surprise billing provision. “The President is saying that all the relevant players — hospitals, doctors, insurance companies — had better get their act together and get legislation passed through Congress that protects patients against surprise medical bills from anybody — hospitals or doctors, doesn’t matter,” he said.

“Those special interest groups need to sort it out and figure out how that would work,” he continued. “There have been legislative packages that have come quite close on the Hill that are bipartisan, but…. the president is saying the time is now. And if they do not get legislation passed by January 1st, he is instructing me to use the full regulatory power of the U.S. government to protect patients against surprise medical bills.”

Sen. Lamar Alexander (R-Tenn.), outgoing chairman of the Senate Health, Education, Labor, & Pensions (HELP) Committee, praised the surprise billing announcement. “The president is right to call on Congress to pass legislation this year to end surprise medical billing,” Alexander said in a statement, adding that a bill currently going through the House and Senate addresses the issue effectively. “Ending surprise medical bills is a problem that requires a permanent solution passed by Congress this year. The American people can’t afford to wait any longer.”

Preexisting Condition Provision Panned

The preexisting condition provision drew scorn from Democratic legislators. The provision “offers no protection not already available through the existing Affordable Care Act (ACA) and no protection for millions of Americans with preexisting conditions if Trump is successful in packing the Supreme Court to destroy the ACA,” Rep. Lloyd Doggett (D-Texas), chairman of the House Ways & Means Health Subcommittee, said in a statement.

But Azar said during the briefing that the ACA’s clause requiring insurers to cover preexisting conditions does no good if people aren’t able to afford insurance in the first place. “If you’re a couple, aged 55, living in Missouri, making $70,000 a year, Obamacare is going to cost you $30,000 in premiums and a $12,000 deductible,” he said.

Azar promised that the administration “will work with Congress or otherwise to ensure” that people with pre-existing conditions are protected, but he did not indicate how that would be made affordable to individuals without government subsidies of the sort Republicans have long opposed.

Bob Laszewski, president of Health Policy and Strategy Associates in Alexandria, Virginia, questioned how much good the executive order’s preexisting condition provision would do. “Trump and the Republicans couldn’t pass an alternative to Obamacare in 2017 when they controlled the White House and both houses of Congress,” he wrote in a blog post. “But, now he can just sign an executive order and everything is fixed? He has signed a number of healthcare-related executive orders and just about all of them are tied up in the byzantine federal regulatory process, or have faded away. This is just an election-year gimmick in an attempt to persuade voters that Trump has healthcare policy under control. There are a lot of governments in the world that operate by executive fiat. Ours is not one of them.”

 

 

 

 

Medicare won’t cover coronavirus vaccines approved under emergency use authorization

https://www.beckershospitalreview.com/pharmacy/medicare-won-t-cover-coronavirus-vaccines-approved-under-emergency-use-authorization.html?utm_medium=email

Medicare Wouldn't Cover Costs of Administering Coronavirus Vaccine Approved  Under Emergency-Use Authorization - WSJ

Medicare won’t cover the cost of a COVID-19 vaccine if it is approved under an emergency use authorization, according to The Wall Street Journal. 

The White House recently concluded that Medicare’s exclusion of emergency-use drug costs could mean 44 million Americans, or 15 percent of the U.S. population, may have to pay out-of-pocket for a vaccine if it is approved under an emergency use authorization, the Journal reported.

HHS is now exploring coverage options, and a spokesperson told the Journal any vaccine doses bought by the government will be provided free.

The administration of President Donald Trump has pushed for a COVID-19 vaccine to be approved and distributed before the presidential election, which would likely only come with an emergency use authorization, since FDA approvals take more time.

In March, lawmakers passed the Coronavirus Aid, Relief, and Economic Security Act, or CARES Act, which ensures no out-of-pocket costs for COVID-19 vaccines for people on Medicare.

HHS also said in August that government health insurance programs, including Medicare and Medicaid, would cover the costs of administering a COVID-19 vaccine. 

 

 

 

 

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.

 

 

 

 

 

Drug pricing politics aren’t dead

https://www.axios.com/newsletters/axios-vitals-319d5198-f7a8-401f-9b00-26118ca0b966.html?utm_source=newsletter&utm_medium=email&utm_campaign=newsletter_axiosvitals&stream=top

Ending The Cycle Of Drug Price Hikes, Death And Outrage | Cognoscenti

President Trump released an executive order yesterday ordering the Department of Health and Human Services to begin the process of limiting what Medicare pays for prescription drugs relative to other countries.

Why it matters: It’s September of an election year. That means that this executive order is, at best, a statement of Trump’s intention to keep trying to achieve something big on drug prices should he get a second term.

  • But given that he’s had four years already to act on what was also a big issue in 2016, there’s plenty of reason to be skeptical of this ever translating into official policy.
  • “President Trump’s executive order on drug pricing does not by itself do anything. It has to be followed up by regulations, which will take time. Trump has a history of bold talk on drug prices, only to pull back when it comes to putting actual regulations in place,” the Kaiser Family Foundation’s Larry Levitt tweeted.

Details: The order calls for Medicare to receive the “most-favored-nation” price for certain drugs.

  • This price is defined as “the lowest price, after adjusting for volume and differences in national gross domestic product, for a pharmaceutical product that the drug manufacturer sells in a member country of the [OECD] that has a comparable per-capita gross domestic product.”

The bottom line: Trump and Joe Biden have both pitched aggressive drug pricing policies — a good reminder that once we get the pandemic under control, the issue is bound to become front-and-center again.

 

 

 

 

Billions in Hospital Virus Aid Rested on Compliance With Private Vendor

Billions in Hospital Virus Aid Rested on Compliance With Private ...

The Department of Health and Human Services told hospitals in April that reporting to the vendor, TeleTracking Technologies, was a “prerequisite to payment.”

The Trump administration tied billions of dollars in badly needed coronavirus medical funding this spring to hospitals’ cooperation with a private vendor collecting data for a new Covid-19 database that bypassed the Centers for Disease Control and Prevention.

The highly unusual demand, aimed at hospitals in coronavirus hot spots using funds passed by Congress with no preconditions, alarmed some hospital administrators and even some federal health officials.

The office of the health secretary, Alex M. Azar II, laid out the requirement in an April 21 email obtained by The New York Times that instructed hospitals to make a one-time report of their Covid-19 admissions and intensive care unit beds to TeleTracking Technologies, a company in Pittsburgh whose $10.2 million, five-month government contract has drawn scrutiny on Capitol Hill.

“Please be aware that submitting this data will inform the decision-making on targeted Relief Fund payments and is a prerequisite to payment,” the message read.

The financial condition, which has not been previously reported, applied to money from a $100 billion “coronavirus provider relief fund” established by Congress as part of the $2.2 trillion Coronavirus Aid, Relief and Economic Security Act, or CARES Act, signed by President Trump on March 27. Two days later, the administration instructed hospitals to make daily reports to the C.D.C., only to change course.

“Another data reporting ask,” a regional official in the health department informed colleagues in an email exchange obtained by The Times, adding: “It comes with $$ incentive. We really need a consolidated message on the reporting/data requests, this is past ridiculous.”

A colleague replied, “Another wrinkle. What a mess.”

The disclosure of the demand in April is the most striking example to surface of the department’s efforts to expand the role of private companies in health data collection, a practice that critics say infringes on what has long been a central mission of the C.D.C. Last month, the federal health department moved beyond financial incentives and abruptly ordered hospitals to send daily coronavirus reports to TeleTracking, not the C.D.C., raising concerns about transparency and reliability of the data.

Officials at the Department of Health and Human Services say that the moves were necessary to improve and streamline data collection in a crisis, and that the one-time reports collected in April by TeleTracking were not available from any other source.

“The national health system has not been challenged in this way in any time in recent history,” Caitlin Oakley, a department spokeswoman, said in a statement, adding that TeleTracking offered a “standardized national hospital capacity tracking system which provided more real-time, better informed data to make decisions from.”

But critics remain alarmed.

“In the middle of a pandemic, the Trump administration is using funds meant to support hospitals as a tool to coerce them to use an unproven, untrusted and deeply flawed system that sidelines public health experts,” Senator Patty Murray of Washington, the ranking Democrat on the Senate Health Committee, said in a statement.

In a statement, TeleTracking said it has three decades of experience providing health care systems “with actionable data and unprecedented visibility to make better, faster decisions.”

Still, public health experts and hospital executives are puzzled as to why the health agency chose such a difficult time to employ an untested private vendor rather than improve the C.D.C.’s National Healthcare Safety Network, a decades-old disease tracking system that was deeply familiar to hospitals and state health departments.

The N.H.S.N., as it is known, had built up trust over decades of working with hospitals and state health departments. Administrators were reluctant to make the switch.

“People — especially in public health and clinical health — are very protective of their data, so that trust factor is certainly an issue,” said Patina Zarcone, the director of informatics for the Association of Public Health Laboratories. “The fear of having their data leaked or misused or used for a purpose that they weren’t aware of or agreed to — I think that’s the biggest rub.”

Ms. Oakley said the C.D.C.’s system was “not designed for use in a disaster response” and could not adapt quickly in a crisis. Allies of the C.D.C. say withholding taxpayer dollars from the CARES Act in lieu of cooperation was an inappropriate effort to push hospitals into a system they were reluctant to use.

“It’s an absolutely enormous lever,” said William Schaffner, an infectious disease expert at Vanderbilt University. “It’s a compulsion to oblige institutions to report to this TeleTracking system because they knew if it weren’t tied to money, it wouldn’t happen.”

The Pittsburgh company has no obvious ties to the Trump administration. Rather, the push appears to be part of a broader privatization. The Health and Human Services Department has also asked the Minnesota-based manufacturer 3M “to create, and continuously update, a nationwide clinical data set on Covid-19 treatment,” according to documents obtained by The Times.

The effort is separate from the TeleTracking data collection. Tim Post, a company spokesman, said that because 3M already operates hospital information systems, it is “uniquely positioned,” with the permission of its clients, to submit information to the health department to help officials study disease patterns and recommend treatment options.

Some experts say this kind of cooperation with the private sector is long overdue. But the push also appears to be driven at least in part by an intensifying rift between the C.D.C., based in Atlanta, and officials at the White House and Department of Health and Human Services, the parent agency of the disease control centers.

Dr. Deborah L. Birx, the White House coronavirus response coordinator, and Mark Meadows, the president’s chief of staff, have taken a dim view of the C.D.C. and believe its reporting systems were inadequate. In a recent interview, Michael Caputo, the spokesman for Mr. Azar, accused the C.D.C. of having “a tantrum.”

Accurate hospital data — including information about coronavirus caseloads, deaths, bed capacity and personal protective equipment — is essential to tracking the pandemic and guiding government decisions about how to distribute scarce resources, like ventilators and the drug remdesivir, the only approved treatment for hospitalized Covid-19 patients.

The health agency has set up a new database, H.H.S. Protect, to collect and analyze Covid-19 data from a range of sources. TeleTracking feeds hospital data to that system.

But the public rollout of H.H.S. Protect has been rocky. The nonpartisan Covid Tracking Project identified big disparities between hospital data reported by states and the federal government and deemed the federal data “unreliable.”

The tension dates to March, when the novel coronavirus was making its first surge in the United States

On March 29, Vice President Mike Pence, charged by Mr. Trump with overseeing the federal response, informed hospital administrators that the C.D.C. was setting up a “Covid-19 Module,” and asked them to file daily reports which, he said, were “necessary in monitoring the spread of severe Covid-19 illness and death as well as the impact to hospitals.”

But around that time, TeleTracking submitted a proposal for data collection to the Trump administration, through an initiative, ASPR Next, created to promote innovation. On April 10, TeleTracking was awarded its contract.

The health department’s spokeswoman said the intent was to complement the C.D.C., not compete with it. Like the C.D.C.’s network, TeleTracking’s system requires manual reporting on a daily basis. But in June, Ms. Murray demanded the administration provide more information about what she called a “multimillion-dollar contract” for a “duplicative health data system.”

Some hospital officials also objected to the change.

“We have been directing our hospitals to N.H.S.N.,” Jackie Gatz, a vice president of the Missouri Hospital Association, wrote to a regional health and human services official in an email obtained by The Times, “and now this email with a much greater carrot — CARES Act distributions — is routing them to TeleTracking.”

When the order was delivered, flaws had already emerged in the new system.

“H.H.S. has acknowledged long wait times for those calling for technical support, and indicated that TeleTracking recently added 100 staff to respond to call center requests,” the American Hospital Association wrote to its members in a “special bulletin” on April 23. “They also are directing hospitals to leave a message if they are unable to reach someone live.”

At the time, hospitals had the option of making their daily coronavirus reports to TeleTracking or the C.D.C. Few were using the new database.

In June, the administration again used a stick to demand that hospitals report to TeleTracking, this time in order to obtain remdesivir. By July, with Dr. Birx pushing to bolster hospital compliance, the administration instructed hospitals to stop filing daily reports to the C.D.C. and to send them to TeleTracking instead.

One official at a major academic hospital, who spoke on the condition of anonymity for fear of angering officials in Washington, said the switch left her “unable to sleep at night.”

“Ethically, it felt like they had taken a very trusted institution in the C.D.C. and all of that trust built up with many public health people,” she said, then “moved it onto a politically and financially motivated portion of this response.”

Health and human services officials say the government now has a much more complete picture of hospital bed capacity, with more than 90 percent of hospitals reporting. But Dr. Janis M. Orlowski, the chief health officer for the Association of American Medical Colleges, who worked with Dr. Birx and the administration to bolster hospital reporting, said that she was “stunned” by the switch and that the increase in reporting came because of efforts by her group and others, not the TeleTracking system.

Dr. Orlowski said the data and maps now published on the administration’s H.H.S. Protect data hub are “just not as sophisticated as the C.D.C.”

The switch also generated pushback inside the C.D.C., where officials have refused to analyze and publish TeleTracking data, saying they could not be assured of its quality and had continuing questions about its accuracy, according to a senior federal health official.

Administration officials say the C.D.C. is working with a little-known office in the executive branch — the United States Digital Service — to build a “modernized automation process” in which data will continue to flow directly to the Department of Health and Human Services. But the project is in its infancy, one senior federal health official said.

Critics say that if the department believed the C.D.C.’s health network had problems, those should have been fixed.

“We have a public health system that depends upon communication from hospitals to state health departments to the C.D.C.,” said Dr. Schaffner, the Vanderbilt University infectious disease expert. “It’s very well established. Can it be improved? Of course. But to cut out the public health infrastructure and report to a private firm essential public health data is misguided in the extreme.”

 

 

 

Drugmakers getting bolder in fight over 340B drug discounts

https://www.fiercehealthcare.com/hospitals/drug-makers-getting-bolder-fight-over-340b-drug-discounts?mkt_tok=eyJpIjoiTTJRMlkySTJZV1ZoWldGbSIsInQiOiJYVUFLbDJLQ2hkbzBrWjBpOVwvbm5YYUpVWExRZ21QRXBkWGJFWldLVGxCZXlFOENlazZBdUhpVm5RUTczOGFxZFVLSEszOTZra20zYzdOQllvMjVHVXNvOUFcL0J3Rk0reFwvV1VHRytoUTYwaDNxelgwcmw5RHhuSEZtNGtlcXZ6MCJ9&mrkid=959610

Drugmakers getting bolder in fight over 340B drug discounts ...

Drugmakers are getting bolder in their bid to restrict access to drugs discounted under the 340B program as legal experts say a lack of enforcement has created a regulatory void.

Hospitals are imploring the Department of Health and Human Services (HHS) to clamp down on several moves by drug companies, including Novartis and AstraZeneca, to limit distribution of certain 340B drugs. But experts say an administration-wide change in what agencies can enforce is likely behind drugmakers’ aggressive moves.

“It is an outrage that these actions are being taken at a time when hospitals are in the midst of their response to the COVID-19 public health emergency, which has further demonstrated the fractured, inadequate state of the prescription drug supply chain,” the American Hospital Association said in a release last week.

Hospitals and 340B advocates are furious that AstraZeneca announced last Friday that starting Oct. 1 it will not offer any discounted drugs to contract pharmacies, which are third-party entities that dispense drugs acquired under the program. 

It is the most aggressive move in a fight sparked last month between drug companies against contract pharmacies, which are a popular tool among 340B hospitals.

The back story

In exchange for participating in Medicaid, a drug manufacturer is required to offer discounts to safety-net hospitals that participate in 340B. But the program has been beset with controversy in recent years as drug companies claim the program has gotten too large and patients aren’t benefiting from the discounts.

Eli Lilly decided last month to restrict sales to contract pharmacies of certain formulations of erectile dysfunction drug Cialis. Merck and Novartis also said contract pharmacies would need to submit claims data to avoid duplicate discounts.

We’ve reached out to pharmaceutical companies for comment and will update when we hear back.

Industry advocacy organization Pharmaceutical Research and Manufacturers of America (PhRMA) has previously called for reforms to the 340B program, including to the ability for covered entities to contract with multiple outside pharmacies to dispense drugs that receive 340B discounts. Even though the number of Americans who are insured has risen, 340B is growing exponentially, they said. “Not all 340B hospitals are good stewards of the program,” PhRMA said.

Hospital groups and 340B allies charge that the moves blatantly violate a 2010 guidance released by the Health Resources and Services Administration (HRSA), which oversees the 340B program.

The guidance permits a hospital participating in 340B to voluntarily use a contract pharmacy and outlines the requirements to do so. The guidance also says a manufacturer must still sell a drug at a price not to exceed the statutory 340B price.

But an October 2019 executive order said federal agencies cannot enforce guidance documents unless they are part of a contract amid other exceptions.

HRSA has said that it doesn’t have the authority under the 340B statute to take enforcement action on “requirements that have been established under guidance,” said Emily Cook, a partner with law firm McDermott Will & Emery.

The agency’s current position is that it can only take enforcement actions on clear violations of the 340B statute, she added.

HRSA told Fierce Healthcare in a statement it is considering the issues raised by the manufacturers and “evaluating our next steps.”

What’s next

Hospitals are hoping HHS steps in and clears up the issue.

If not, then hospitals could either take drug companies to court or lobby Congress to give HRSA more authority over the program.

The advocacy group 340B Health said last week that if the administration refuses to step in then it will “pursue all legislative and legal avenues available to us to defend the safety net.”

Hospitals need to re-examine their 340B contract pharmacy deals to exclude AstraZeneca drugs, according to an article from Brenda Maloney Shafer and Richard Davis of law firm Quarles & Brady.

If they fail to do this, then the contract pharmacy could pay for dispensing and administrative fees for drugs that won’t get a 340B discount.

This is the latest spat over the controversial program. Hospitals took the administration to court after it tried to cut payments under the program by nearly 30%.

An appeals court recently ruled that HHS does have the authority to institute the cuts.