Category Archives: Supply Chain

No Easy Fixes for Drug Supply Chain Problems

Posted on by • Posted in Disruption, Food and Drug Administration (FDA), Health Policy, Pharmaceutical Industry, Prescription Drugs, Supply Chain, Vaccine • Leave a comment
https://www.medpagetoday.com/publichealthpolicy/healthpolicy/90067?xid=nl_covidupdate_2020-12-08&eun=g885344d0r&utm_source=Sailthru&utm_medium=email&utm_campaign=DailyUpdate_120820&utm_term=NL_Gen_Int_Daily_News_Update

Better leadership is needed on both ends of the chain, expert says.

The U.S. drug supply chain works well in the middle, but the beginning and end leave much room for improvement, according to Stephen Schondelmeyer, PharmD, PhD, of the University of Minnesota in Minneapolis.

“When a manufacturer imports a drug into the U.S. and sells it to wholesalers and then it goes to group purchasing organizations and through hospital institutional systems, that system works very well,” Schondelmeyer said last week at a public workshop of the National Academies of Science, Engineering, and Medicine’s Committee on Security of Medical Product Supply Chain. “But where problems occur is when the API [active pharmaceutical ingredient] is not being produced or is not available, or is not shipped to the finished dose manufacturer to make enough.” With the current “just in time” manufacturing system, “inventories may only last a month” before supplies dry up, he said.

Leadership on this issue “is certainly needed at the top, but also needed at the end,” said Schondelmeyer, who is co-principal investigator of the Resilient Drug Supply Project at the university’s Center for Infectious Disease Research and Policy.

For example, he said, “I routinely meet with groups of pharmacy directors at major hospital systems. I have heard stories from pharmacy directors … who have said they had remdesivir allocated by their state; it showed up in their hospital’s lab. Nobody in the lab knew what it was or why it arrived, and it sat there for several days before they figured out this was a drug and pharmacy should be managing this … You can run a marathon, but if you don’t finish the last 200 yards, you don’t finish the marathon, and that’s what happened with remdesivir.”

“We need to be predicting not only demand changes but what things can create a supply disruption, because a lot of shortages we have are from supply disruption,” Schondelmeyer said. In the COVID-19 era, this could include unexpected political moves such as export bans — such as those recently put in place in India and the United Kingdom — which could mean that “we could find whole categories of drugs not available in the U.S., and we don’t have the capacity to replace that supply, in the short run at least,” he said.

Pharmaceuticals are a very unique market, he added. “We established a pharmaceutical market based on monopolies when drugs first come on the market, via intellectual property, and even later on, when you’re down to two or three generics they function like an oligopoly. We have a marketplace that has extreme asymmetries of information, where people selling a drug know a lot more than people buying the drug. We have to establish an infrastructure to understand the pharmaceutical market and the flow of products so we can correct the market when it’s not working.”

“Our current system of fixing drug shortages is a ‘fail and fix’ system,” he said. The list of shortages “is a list of products that have already failed. I think we should have a system that has supply chain maps that identify critical stages — even pre-API — that can suggest where we might have a failure, and do something before the failure occurs. I suggest we move from ‘fail and fix’ to ‘predict and prevent.'”

Schondelmeyer said he and his colleagues are trying to build such supply chain maps, “but really the government should be doing that … I don’t fault the FDA; the FDA may or may not be the right place to do that.” But more agencies and other players need to be involved because “no one player in the market can solve this problem alone.”

Schondelmeyer displayed percentages of various drug types that were in shortage. Among 156 “critical acute care drugs” — those that must be used within hours or days of an illness’s onset to avoid serious outcomes or death — the FDA found 25.6% were in shortage, while the American Society of Hospital Pharmacists (ASHP) found that 41.7% of them were in shortage, “and this was even before COVID-19,” he said. Among a list of 40 “critical COVID-19 drugs,” the FDA has listed 45% of them as being in shortage, while the ASHP rated 75% as being in shortage. “Most were in short supply even before COVID-19 hit,” he added. “These are alarming levels of shortage and they have persisted.”

Many people suggest that the supply chain problem can be solved by moving manufacturing for particular drug products from overseas to a U.S. plant, but that doesn’t quite solve the problem, said Schondelmeyer. “If we manufactured our entire supply of drugs in the U.S., it doesn’t solve the problem if you put all the manufacturing in one facility and it gets wiped out by a hurricane,” he said, recalling what happened when a hurricane hit Puerto Rico, the home of several medical product manufacturers. “Hospitals were scrambling to get things like normal saline. So simply bringing production back to the U.S. but concentrating it in one place doesn’t solve the problem — it just moves the problem.”

Khatereh Calleja, president and CEO of the Healthcare Supply Chain Association, agreed. “We’ve got to focus on this very issue of geographic diversity,” Calleja said. “Otherwise we’re creating a risk when we create that concentration.”

When people are discussing the supply chain, having a common language among institutions is also important, said Chris Liu, director of enterprise services for the state of Washington, “In hospitals, ‘conservation’ of PPE [personal protective equipment] means something different at every hospital you go to,” he said.

Another thing that needs to be taken on is the vulnerability of drug precursors, said James Lawler, director of international programs and innovation at the University of Nebraska’s Global Center for Health Security. “It’s one thing if the plant that makes the final small-molecule antibiotic … is in the U.S., but if all the precursor chemicals they require to synthesize that product come from overseas, you haven’t necessarily fixed your supply chain vulnerability.”

Now the U.S. Has Lots of Ventilators, but Too Few Specialists to Operate Them

Posted on by • Posted in Asymptomatic Transmission, Clinical Testing, Coronavirus, Coronavirus Treatment, Crisis, Crisis Management, Economic Crisis, Economic Recovery, Emergency Care, Emergency Preparedness, Emergency Room Staffing, Evidence-Based Care, Evidence-based Leadership, Evidence-Based Plan, Evidence-Based Policy, False Hope, False Narrative, Health System, Hospital, Hospital Industry, Infection Control, Infection Control Plan, Infectious Virus, Leadership Decentralized, Misinformation, Misinterpret, Mislead, Misleading, Mistake, Mistrust, Mixed Message, Mortality, National Strategy, Out of Control, Pandemic, Personal Protective Equipment (PPE), Public Health, Public Opinion, Public Perception, Public Safety, Public Trust, Quarantine, Scientists, Social Distancing, Supply Chain, Ventilators • Leave a comment
A patient was placed on a ventilator in a hospital in Yonkers, N.Y., in April.

As record numbers of coronavirus cases overwhelm hospitals across the United States, there is something strikingly different from the surge that inundated cities in the spring: No one is clamoring for ventilators.

The sophisticated breathing machines, used to sustain the most critically ill patients, are far more plentiful than they were eight months ago, when New York, New Jersey and other hard-hit states were desperate to obtain more of the devices, and hospitals were reviewing triage protocols for rationing care. Now, many hot spots face a different problem: They have enough ventilators, but not nearly enough respiratory therapists, pulmonologists and critical care doctors who have the training to operate the machines and provide round-the-clock care for patients who cannot breathe on their own.

Since the spring, American medical device makers have radically ramped up the country’s ventilator capacity by producing more than 200,000 critical care ventilators, with 155,000 of them going to the Strategic National Stockpile. At the same time, doctors have figured out other ways to deliver oxygen to some patients struggling to breathe — including using inexpensive sleep apnea machines or simple nasal cannulas that force air into the lungs through plastic tubes.

But with new cases approaching 200,000 per day and a flood of patients straining hospitals across the country, public health experts warn that the ample supply of available ventilators may not be enough to save many critically ill patients.

“We’re now at a dangerous precipice,” said Dr. Lewis Kaplan, president of the Society of Critical Care Medicine. Ventilators, he said, are exceptionally complex machines that require expertise and constant monitoring for the weeks or even months that patients are tethered to them. The explosion of cases in rural parts of Idaho, Ohio, South Dakota and other states has prompted local hospitals that lack such experts on staff to send patients to cities and regional medical centers, but those intensive care beds are quickly filling up.

Public health experts have long warned about a shortage of critical care doctors, known as intensivists, a specialty that generally requires an additional two years of medical training. There are 37,400 intensivists in the United States, according to the American Hospital Association, but nearly half of the country’s acute care hospitals do not have any on staff, and many of those hospitals are in rural areas increasingly overwhelmed by the coronavirus.

“We can’t manufacture doctors and nurses in the same way we can manufacture ventilators,” said Dr. Eric Toner, an emergency room doctor and senior scholar at the Johns Hopkins Center for Health Security. “And you can’t teach someone overnight the right settings and buttons to push on a ventilator for patients who have a disease they’ve never seen before. The most realistic thing we can do in the short run is to reduce the impact on hospitals, and that means wearing masks and avoiding crowded spaces so we can flatten the curve of new infections.”

Medical association message boards in states like Iowa, Oklahoma and North Dakota are awash in desperate calls for intensivists and respiratory therapists willing to temporarily relocate and help out. When New York City and hospitals in the Northeast issued a similar call for help this past spring, specialists from the South and the Midwest rushed there. But because cases are now surging nationwide, hospital officials say that most of their pleas for help are going unanswered.

Dr. Thomas E. Dobbs, the top health official in Mississippi, said that more than half the state’s 1,048 ventilators were still available, but that he was more concerned with having enough staff members to take care of the sickest patients.

“If we want to make sure that someone who’s hospitalized in the I.C.U. with the coronavirus has the best chance to get well, they need to have highly trained personnel, and that cannot be flexed up rapidly,” he said in a news briefing on Tuesday.

Dr. Matthew Trump, a critical care specialist at UnityPoint Health in Des Moines, said that the health chain’s 21 hospitals had an adequate supply of ventilators for now, but that out-of-state staff reinforcements might be unlikely to materialize as colleagues fall ill and the hospital’s I.C.U. beds reach capacity.

“People here are exhausted and burned out from the past few months,” he said. “I’m really concerned.”

The domestic boom in ventilator production has been a rare bright spot in the country’s pandemic response, which has been marred by shortages of personal protective equipment, haphazard testing efforts and President Trump’s mixed messaging on the importance of masks, social distancing and other measures that can dent the spread of new infections.

Although the White House has sought to take credit for the increase in new ventilators, medical device executives say the accelerated production was largely a market-driven response turbocharged by the national sense of crisis. Mr. Trump invoked the wartime Defense Production Act in late March, but federal health officials have relied on government contracts rather than their authority under the act to compel companies to increase the production of ventilators.

Scott Whitaker, president of AdvaMed, a trade association that represents many of the country’s ventilator manufacturers, said the grave situation had prompted a “historic mobilization” by the industry. “We’re confident that our companies are well positioned to mobilize as needed to meet demand,” he said in an email.

Public health officials in Minnesota, Mississippi, Utah and other states with some of the highest per capita rates of infection and hospitalization have said they are comfortable with the number of ventilators currently in their hospitals and their stockpiles.

Mr. Whitaker said AdvaMed’s member companies were making roughly 700 ventilators a week before the pandemic; by the summer, weekly output had reached 10,000. The juggernaut was in part fueled by unconventional partnerships between ventilator companies and auto giants like Ford and General Motors.

Chris Brooks, chief strategy officer at Ventec Life Systems, which collaborated with G.M. to fill a $490 million contract for the Department of Health and Human Services, said the shared sense of urgency enabled both companies to overcome a thicket of supply-chain and logistical challenges to produce 30,000 ventilators over four months at an idled car parts plant in Indiana. Before the pandemic, Ventec’s average monthly output was 100 to 200 machines.

“When you’re focused with one team and one mission, you get things done in hours that would otherwise take months,” he said. “You just find a way to push through any and all obstacles.”

Despite an overall increase in the number of ventilators, some researchers say many of the new machines may be inadequate for the current crisis. Dr. Richard Branson, an expert on mechanical ventilation at the University of Cincinnati College of Medicine and an author of a recent study in the journal Chest, said that half of the new devices acquired by the Strategic National Stockpile were not sophisticated enough for Covid-19 patients in severe respiratory distress. He also expressed concern about the long-term viability of machines that require frequent maintenance.

“These devices were not built to be stockpiled,” he said.

The Department of Health and Human Services, which has acknowledged the limitations of its newly acquired ventilators, said the stockpile — nine times as large as it was in March — was well suited for most respiratory pandemics. “These stockpiled devices can be used as a short-term, stopgap buffer when the immediate commercial supply is not sufficient or available,” the agency said in a statement.

Projecting how many people will end up requiring mechanical breathing assistance is an inexact science, and many early assumptions about how the coronavirus affects respiratory function have evolved.

During the chaotic days of March and April, emergency room doctors were quick to intubate patients with dangerously low oxygen levels. They subsequently discovered other ways to improve outcomes, including placing patients on their stomachs, a protocol known as proning that helps improve lung function. The doctors also learned to embrace the use of pressurized oxygen delivered through the nose, or via BiPAP and CPAP machines, portable devices that force oxygen into a patient’s airways.

Many health care providers initially hesitated to use such interventions for fear the pressurized air would aerosolize the virus and endanger health care workers. The risks, it turned out, could be mitigated through the use of respirator masks and other personal protective gear, said Dr. Greg Martin, the chief of pulmonary and critical care at Grady Health Systems in Atlanta.

“The familiarity of taking care of so many Covid patients, combined with good data, has just made everything we do 100 times easier,” he said.

Some of the earliest data about the perils of intubating coronavirus patients turned out to be incomplete and misleading. Dr. Susan Wilcox, a critical care specialist at Massachusetts General Hospital, said many providers were spooked by data that suggested an 80 percent mortality rate among ventilated coronavirus patients, but the actual death rate turned out to be much lower. The mortality rate at her hospital, she said, was about 25 to 30 percent.

“Some people were saying that we should intubate almost immediately because we were worried patients would crash and have untoward consequences if we waited,” she said. “But we’ve learned to just go back to the principles of good critical care.”

Survival rates have increased significantly at many hospitals, a shift brought about by the introduction of therapeutics like dexamethasone, a powerful steroid that Mr. Trump took when he was hospitalized with the coronavirus. The changing demographics of the pandemic — a growing proportion of younger patients with fewer health risks — have also played a role in the improving survival rates.

Dr. Nikhil Jagan, a critical care pulmonologist at CHI Health, a hospital chain that serves Iowa, Kansas and Nebraska, said many of the coronavirus patients who were arriving at his emergency room now were less sick than the patients he treated in the spring.

“There’s a lot more awareness about the symptoms of Covid-19,” he said. “The first go-around, when people came in, they were very sick right off the bat and in respiratory distress or at the point of respiratory failure and had to be intubated.”

But the promising new treatments and enhanced knowledge can go only so far should the current surge in cases continue unabated. The country passed 250,000 deaths from the coronavirus last week, a reminder that many critically ill patients do not survive. The daily death toll has been rising steadily and is approaching 2,000.

“Ventilators are important in critical care but they don’t save people’s lives,” said Dr. Branson of the University of Cincinnati. “They just keep people alive while the people caring for them can figure out what’s wrong and fix the problem. And at the moment, we just don’t have enough of those people.”

For now, he said there was only one way out the crisis: “It’s not that hard,” he said. “Wear a mask.”

What do Pfizer’s and Moderna’s COVID-19 vaccine announcements mean for you?

Posted on by • Posted in Centers for Disease Control & Prevention (CDC), Clinical Research, Coronavirus, Food and Drug Administration (FDA), Pandemic, Supply Chain, Supply Chain Cold Logistics Network, Vaccine, Vaccine Distribution • Leave a comment

https://www.politifact.com/article/2020/nov/12/what-does-pfizers-covid-19-announcement-mean-you/

COVID vaccine: What the second shot in the Moderna trial was like

IF YOUR TIME IS SHORT

  • If all goes according to plan, health care workers and individuals at high risk for severe illness from COVID-19 could be vaccinated as early as December.
  • Experts predict that the broader public could start being vaccinated in April.
  • The distribution of the vaccine could present some challenges for state and federal governments. That or any other unexpected events could delay the vaccine’s distribution.

When drugmaker Pfizer announced that its new vaccine was highly effective at preventing COVID-19, it raised hopes that the coronavirus pandemic could be nearing its end. 

In a Nov. 9 press release, the company and its partner BioNTech claimed that an early analysis of clinical trial data found that inoculated individuals experienced 90% fewer cases of symptomatic COVID-19 than those who had received a placebo. 

These results surpassed expectations. For months, experts have warned that a new vaccine might only be 60% effective. If Pfizer’s analysis is accurate — and it has yet to produce official scientific documentation —  the new vaccine would offer a level of protection equal to that of highly effective vaccines for diseases such as measles. 

Experts told us that Pfizer’s announcement is cause for optimism. However, the country, and the world, still have a way to go before coronavirus vaccines become available to ordinary Americans. 

Here’s what we know about when the vaccine might be distributed and what that process could look like. What’s next for Pfizer’s vaccine?

If the information in the press release is accurate, Pfizer will likely be the first company to come up with a vaccine that meets the Food and Drug Administration’s requirements for distribution. 

To get approval from the FDA, Pfizer has to gather two months of safety data on clinical trial participants to gauge whether the treatment has any negative side effects. The company will reach the two-month benchmark in the third week of November. Barring any unexpected developments, it will then submit its vaccine to the FDA for emergency use authorization, a special provision allowing the use of an unapproved product during a state of emergency.  

After Pfizer submits its data to the FDA, the agency will analyze it to see if it’s sufficient to begin distribution. After approval from the FDA, the vaccine would be assessed by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices. The Advisory Committee will then issue a recommendation to the CDC, which will make the final ruling about whether to distribute the vaccine.  

This might sound intricate, but James Blumenstock, the chief program officer for health security at the Association of State and Territorial Health Officials, said that the vaccine could probably be approved by the FDA and the CDC in a matter of days rather than weeks. 

“Both agencies are standing ready and will give these requests and this assessment the highest level of priority just for expediency’s sake,” he said. 

What this means is that high-priority Americans, such as health care workers, could be vaccinated as early as December. What a vaccine rollout might look like.

Pfizer predicts that it will be able to manufacture only 50 million doses for global consumption by the end of the year, enough to vaccinate 25 million people. (The world’s population is about 7.8 billion.)

With a limited number of doses available, the eventual rollout of a vaccine would likely consist of two phases. During the first phase, U.S. health care workers, emergency responders and individuals at higher risk of severe illness would be eligible for vaccination. If all goes according to plan, the first phase will commence sometime in December. 

During the second phase, the vaccine would become available to the broader public. Most experts told us that they expect the second phase to start sometime in April, although the date would vary depending on Pfizer’s vaccine production rates and whether other companies get their vaccines greenlit by the FDA and CDC. The state of other vaccines

As of early July, there were roughly 160 vaccine projects under way worldwide, according to the World Health Organization. 

Pfizer’s announcement bodes well for other vaccine candidates, said Matthew B. Laurens, an associate professor of pediatrics at the University of Maryland School of Medicine’s Center for Vaccine Development and Global Health. 

Pfizer’s vaccine uses genetic material, known as mRNA, that provides the instructions for a body to produce coronavirus proteins, known as antigens, in the hope that these could prime the human immune system to fight the virus. The biotechnology company Moderna is also manufacturing a vaccine that uses mRNA and is set to receive trial data by the end of November. 

Other companies in the United States and Europe producing a vaccine include Novavax, which plans to start clinical trials in the U.S. and Mexico by the end of November; Johnson & Johnson, which recently resumed testing its vaccine candidate after a brief pause; and AstraZeneca, which expects to have clinical trial data by the end of the year. 

The more companies there are that are able to produce a vaccine, the quicker the vaccine will become widely available, experts say.

Vaccine presents potential distribution hurdles

The CDC will be in charge of the distribution process, with involvement from the U.S. Defense Department, said Dr. Litjen Tan, chief strategy officer for the Immunization Action Coalition, which distributes information about vaccines to try to increase vaccination rates. 

Vaccines would be manufactured and then transported to states, which will then pass the vaccine on to providers, such as hospitals. The McKesson Corp., which has received a federal contract to distribute the treatment, will assist pharmaceutical companies and the government with the shipping process. 

Shipping the doses will present some challenges. Pfizer’s vaccine has complex and ultra-cold storage requirements that many hospitals, particularly those in hard-to-reach areas, won’t be able to meet. 

The cold chain requirement “is an issue for Pfizer, but manufacturing and distribution are issues for all vaccines,” said Robert Finberg, a physician and infectious disease specialist at the University of Massachusetts Medical Center.

To surmount this hurdle, Pfizer plans to transport the vaccine in thermal shippers that can keep the vaccine at the necessary temperature of minus 70 degrees Celsius for about two weeks. However, the shippers themselves present additional problems for distribution, Tan said. Each shipment consists of five trays containing 975 doses of vaccine, and reducing the size of the shipment could dramatically raise the cost of distribution. 

As a result, the states might initially prioritize shipping the vaccine to major hospitals rather than rural hospitals that service fewer patients in order to avoid waste. 

Blumenstock told us that state and federal governments are working hard to make sure that all regions of the U.S. receive proportionate amounts of vaccine. However, he acknowledged that hospitals in remote areas that don’t service many patients could initially take longer to get the vaccine than a well-trafficked hospital in a heavily populated area.

“Outskirt hospitals won’t be ignored or marginalized, even if it takes more time and effort to get them the vaccine,” he said. “One of the primary principles will be equitable distribution, even when that means you need to take extraordinary measures for logistics, transportation, and handling.” 

Overall, experts said that Pfizer’s announcement is a significant step forward. “I’m optimistic that we have a vaccine that’s safe and effective,” said Tan. “And I’m glad that what we’re dealing with now is the problem of how to get it to the public.”

What healthcare executives can expect under Biden presidency

Posted on by • Posted in ACA, Asymptomatic Transmission, Centers for Disease Control & Prevention (CDC), Clinical Research, Clinical Testing, Contact Tracing, Coronavirus, Crisis, Crisis Management, Dept of Health and Human Services (HHS), Employer-Based Health Insurance, Essential Health Benefits, Evidence-based Leadership, Evidence-Based Plan, Evidence-Based Policy, Health Insurance Coverage Adequacy, Health Insurance Industry, Health Policy, Health System, Hospital, Hospital Industry, Infection Control, Infection Control Plan, Infectious Virus, Interoperability, Leadership Alignment, Leadership Cares, Leadership Commitment, Leadership Intent, Market Consolidation, Market Power, Market Trends, Medicaid, Medicaid Expansion, Medicare, Medicare Advantage, Mergers & Acquisitions, Mortality, National Strategy, Pandemic, Pharmaceutical Industry, Preexisting Conditions, Price Transparency, Public Health, Public Opinion, Public Option, Public Perception, Public Safety, Public Trust, Quarantine, Scientists, Social Distancing, Supply Chain, Underinsured, Unemployment, Unemployment Insurance, Uninsured, Value Creation, Value-Based Contracting, Value-Based Healthcare, Workforce Strategy, World Health Organization (WHO) • Leave a comment

https://www.beckershospitalreview.com/hospital-management-administration/pwc-what-healthcare-executives-can-expect-under-biden-presidency.html?utm_medium=email

https://www.pwc.com/us/Biden2020healthagenda

President-elect Joe Biden’s healthcare agenda: building on the ACA, value-based care, and bringing down drug prices.

In many ways, Joe Biden is promising a return to the Obama administration’s approach to healthcare:

  • Building on the Affordable Care Act (ACA) through incremental expansions in government-subsidized coverage
  • Continuing CMS’ progress toward value-based care
  • Bringing down drug prices
  • Supporting modernization of the FDA

Bolder ideas, such as developing a public option, resolving “surprise billing,” allowing for negotiation of drug prices by Medicare, handing power to a third party to help set prices for some life sciences products, and raising the corporate tax rate, could be more challenging to achieve without overwhelming majorities in both the House and the Senate.

Biden is likely to mount an intensified federal response to the COVID-19 pandemic, enlisting the Defense Production Act to compel companies to produce large quantities of tests and personal protective equipment as well as supporting ongoing deregulation around telehealth. The Biden administration also will likely return to global partnerships and groups such as the World Health Organization, especially in the area of vaccine development, production and distribution.

What can health industry executives expect from Biden’s healthcare proposals?

Broadly, healthcare executives can expect an administration with an expansionary agenda, looking to patch gaps in coverage for Americans, scrutinize proposed healthcare mergers and acquisitions more aggressively and use more of the government’s power to address the pandemic. Executives also can expect, in the event the ACA is struck down, moves by the Biden administration and Democratic lawmakers to develop a replacement. Healthcare executives should scenario plan for this unlikely yet potentially highly disruptive event, and plan for an administration marked by more certainty and continuity with the Obama years.

All healthcare organizations should prepare for the possibility that millions more Americans could gain insurance under Biden. His proposals, if enacted, would mean coverage for 97% of Americans, according to his campaign website. This could mean millions of new ACA customers for payers selling plans on the exchanges, millions of new Medicaid beneficiaries for managed care organizations, millions of newly insured patients for providers, and millions of covered customers for pharmaceutical and life sciences companies. The surge in insured consumers could mirror the swift uptake in the years following the passage of the ACA.

Biden’s plan to address the COVID-19 pandemic

Biden is expected to draw on his experience from H1N1 and the Ebola outbreaks to address the COVID-19 pandemic with a more active role for the federal government, which many Americans support. These actions could shore up the nation’s response in which the federal government largely served in a support role to local, state and private efforts.

Three notable exceptions have been the substantial federal funding for development of vaccines against the SARS-CoV-2 virus, Congress’ aid packages and the rapid deregulatory actions taken by the FDA and CMS to clear a path for medical products to be enlisted for the pandemic and for providers, in particular, to be able to respond to it.

Implications of Biden’s 2020 health agenda on healthcare payers, providers and pharmaceutical and life sciences companies

The US health system has been slowly transforming for years into a New Health Economy that is more consumer-oriented, digital, virtual, open to new players from outside the industry and focused on wellness and prevention.  The COVID-19 pandemic has accelerated some of those trends.  Once the dust from the election settles, companies that have invested in capabilities for growth and are moving forcefully toward the New Health Economy stand to gain disproportionately.

Shortages of clinicians and foreign medical students may continue to be an issue for a while

The Trump administration made limiting the flow of immigrants to the US a priority. The associated policy changes have the potential to exacerbate shortages of physicians, nurses and other healthcare workers, including medical students. These consequences have been aggravated by the pandemic, which dramatically curtailed travel into the US.

  • Healthcare organizations, especially rural ones heavily dependent on foreign-born employees, may find themselves competing fiercely for workers, paying higher salaries and having to rethink the structure of their workforces.
  • Providers should consider reengineering primary care teams to reflect the patients’ health status and preferences, along with the realities of the workforce on the ground and new opportunities in remote care.

Focus on modernizing the supply chain

Biden and lawmakers from both parties have been raising questions about life sciences’ supply chains. This focus has only intensified because of the pandemic and resulting shortages of personal protective equipment (PPE), pharmaceuticals, diagnostic tests and other medical products.

  • Investment in advanced analytics and cybersecurity could allow manufacturers to avoid disruptive stockouts and shortages, and deliver on the promise of the right treatment to the right patient at the right time in the right place.

Drug pricing needs a long-term strategy

Presidents and lawmakers have been talking about drug prices for decades; few truly meaningful actions have been implemented. Biden has made drug pricing reform a priority.

  • Drug manufacturers may need to start looking past the next quarter to create a new pricing strategy that maximizes access in local markets through the use of data and analytics to engage in more value-based pricing arrangements.
  • New financing models may help patients get access to drugs, such as subscription models that provide unlimited access to a therapy at a flat rate.
  • Companies that prepare now to establish performance metrics and data analytics tools to track patient outcomes will be well prepared to offer payers more sustainable payment models, such as mortgage or payment over time contracts, avoiding the sticker shock that comes with these treatments and improving uptake at launch.
  • Pharmaceutical and life sciences companies will likely have to continue to offer tools for consumers like co-pay calculators and use the contracting process where possible to minimize out-of-pocket costs, which can improve adherence rates and health outcomes.

View interoperability as an opportunity to embrace, not a threat to avoid or ignore

While the pandemic delayed many of the federal interoperability rule deadlines, payers and providers should use the extra time to plan strategically for an interoperable future.

  • Payers should review business partnerships in this new regulatory environment.
  • Digital health companies and new entrants may help organizations take advantage of the opportunities that achieving interoperability may present.
  • Companies should consider the legal risks and take steps to protect their reputations and relationships with customers by thinking through issues of consent and data privacy.

Health organizations should review their policies and consider whether they offer protections for customers under the new processes and what data security risks may emerge. They should also consider whether business associate agreements are due in more situations.

Plan for revitalized ACA exchanges and a booming Medicare Advantage market

The pandemic has thrown millions out of work, generating many new customers for ACA plans just as the incoming Biden administration plans to enrich subsidies, making more generous plans within reach of more Americans.

  • Payers in this market should consider how and where to expand their membership and appeal to those newly eligible for Medicare. Payers not in this market should consider partnerships or acquisitions as a quick way to enter the market, with the creation of a new Medicare Advantage plan as a slower but possibly less capital-intensive entry into this market.
  • Payers and health systems should use this opportunity to design more tailored plan options and consumer experiences to enhance margins and improve health outcomes.
  • Payers with cash from deferred care and low utilization due to the pandemic could turn to vertical integration with providers as a means of investing that cash in a manner that helps struggling providers in the short term while positioning payers to improve care and reduce its cost in the long term.
  • Under the Trump administration, the FDA has approved historic numbers of generic drugs, with the aim of making more affordable pharmaceuticals available to consumers. Despite increased FDA generics approvals, generics dispensed remain high but flat, according to HRI analysis of FDA data.
  • Pharmaceutical company stocks, on average, have climbed under the Trump administration, with a few notable dips due to presidential speeches criticizing the industry and the pandemic.
  • Providers have faced some revenue cuts, particularly in the 340B program, and many entered the pandemic in a relatively weak liquidity position.  The pandemic has led to layoffs, pay cuts and even closures. HRI expects consolidation as the pandemic continues to curb the flow of patients seeking care in emergency departments, orthopedic surgeons’ offices, dermatology suites and more.

Lawmakers and politicians often use bold language, and propose bold solutions to problems, but the government and the industry itself resists sudden, dramatic change, even in the face of sudden, dramatic events such as a global pandemic. One notable exception to this would be a decision by the US Supreme Court to strike down the ACA, an event that would generate a great deal of uncertainty and disruption for Americans, the US health industry and employers.

Pfizer vaccine needs to be stored at ultra-cold temperatures that could significantly complicate distribution

Posted on by • Posted in Clinical Research, Coronavirus, Pandemic, Supply Chain, Supply Chain Cold Logistics Network, Vaccine, Vaccine Efficacy, Vaccine Ultracold Storage, World Health Organization (WHO) • Leave a comment
https://www.washingtonpost.com/nation/2020/11/09/coronavirus-covid-live-updates-us/?wpmk=1&wpisrc=al_news__alert-hse–alert-national&utm_source=alert&utm_medium=email&utm_campaign=wp_news_alert_revere&location=alert&pwapi_token=eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJjb29raWVuYW1lIjoid3BfY3J0aWQiLCJpc3MiOiJDYXJ0YSIsImNvb2tpZXZhbHVlIjoiNWI2M2EzNDJhZGU0ZTI3Nzk1NTBjYTFiIiwidGFnIjoid3BfbmV3c19hbGVydF9yZXZlcmUiLCJ1cmwiOiJodHRwczovL3d3dy53YXNoaW5ndG9ucG9zdC5jb20vbmF0aW9uLzIwMjAvMTEvMDkvY29yb25hdmlydXMtY292aWQtbGl2ZS11cGRhdGVzLXVzLz93cG1rPTEmd3Bpc3JjPWFsX25ld3NfX2FsZXJ0LWhzZS0tYWxlcnQtbmF0aW9uYWwmdXRtX3NvdXJjZT1hbGVydCZ1dG1fbWVkaXVtPWVtYWlsJnV0bV9jYW1wYWlnbj13cF9uZXdzX2FsZXJ0X3JldmVyZSZsb2NhdGlvbj1hbGVydCJ9.InT0k3jxTJfTh5KA7asZ9LJAVADgvd0AfA6jsvscCNk
Satire: No charges for Iowa man arrested after he dressed up as Mr Freeze and shouted nonconsensual polar vortex puns in public | Boing Boing

A promising vaccine developed by drug giant Pfizer and German biotechnology firm BioNTech would need to be stored at ultracold temperatures that experts say could make it far more difficult to distribute than other potential vaccines.

Pfizer announced Monday that an interim analysis had shown the vaccine was more than 90 percent effective, news that was greeted with near universal celebration among experts.

But the Pfizer vaccine is relatively unusual as it has to be stored and transported at an ultracold temperature of around -94 Fahrenheit (-70 Celsius), significantly complicating the process of getting the vaccine to people.

Ultracold storage is “is not necessarily routinely available in most health centers even in the U.K., let alone globally,” Michael Head, a fellow in global health at the University of Southampton said in a statement.

Vaccines often require some kind of cold storage to remain effective; some candidates for a coronavirus vaccine need to be held at cooler temperatures like 26 Fahrenheit (2 Celsius). They need to be kept this temperature not only while in storage but also while being delivering on planes and trucks.

The Pfizer vaccine would be considerably colder, requiring more than just refrigeration but something capable of producing freezing temperatures even during potential lengthy periods of transport. It has been done before, though at a smaller scale: A vaccine for the Ebola virus was notable for requiring ultracold storage. Pfizer has been preparing for the challenge by creating special containers that can last 10 days at -94 Fahrenheit, according to the Wall Street Journal.

Groups like the World Health Organization and UNICEF have said that countries need to improve their “cold chain” logistical networks to make sure vaccines can be distributed safely. The Associated Press reported last month that nearly 3 billion people live in areas where temperature-controlled storage is insufficient for the task.

Face Masks Are Again in Short Supply as Covid-19 Cases Surge

Posted on by • Posted in 2020 Election Issues, Coronavirus, Crisis, Crisis Management, Economic Crisis, Economic Recovery, Evidence-based Leadership, Evidence-Based Plan, Evidence-Based Policy, Infection Control, Infection Control Plan, Infectious Virus, Leadership Decentralized, Mortality, National Strategy, Pandemic, Personal Protective Equipment (PPE), Public Health, Public Opinion, Public Perception, Public Safety, Public Trust, Quarantine, Scientists, Social Distancing, Supply Chain • Leave a comment

https://www.wsj.com/articles/face-masks-are-again-in-short-supply-as-covid-19-cases-surge-11604499588?mod=hp_lead_pos5

Face Masks Are Again in Short Supply as Covid-19 Cases Surge - WSJ

Despite increased production of protective gear, levels of N95 face masks are lower than recommended at many health-care facilities.

Manufacturers and health officials are reporting shortages of N95 masks, critical protective equipment for frontline workers (WSJ). Although supplies of masks, gloves, and other equipment have improved since the start of the pandemic, new Covid-19 surges around the country are making it difficult for health care facilities to keep up with demand for N95 masks.

Many facilities are being forced to ration and reuse supplies. In Michigan, approximately two-thirds of health systems report less than a three-week supply of protective equipment, far below the state’s recommended 90-day supply. In New Mexico, 90% of hospitals are now reusing N95 masks. State health officials around the country expect shortages to be exacerbated in the coming weeks as Covid-19 cases continue to rise.

Manufacturers are scrambling to keep up, ramping up production, and working with state officials to direct supplies to areas in greatest need. 3M, the largest manufacturer of N95 masks in the country, is producing four times the number of N95 masks per month compared to pre-pandemic production. Even so, Chief Executive Mike Roman told reporters, “N95s are still in high demand. We have more demand than we can supply.”

U.S. reports record-breaking number of daily COVID-19 cases, but experts say the worst is yet to come

Posted on by • Posted in 2020 Election Issues, Asymptomatic Transmission, Clinical Testing, Contact Tracing, Coronavirus, Crisis, Crisis Management, Economic Crisis, Economic Recovery, Evidence-based Leadership, Evidence-Based Plan, Evidence-Based Policy, Health Policy, Health System, Hospital, Hospital Industry, Infection Control, Infection Control Plan, Infectious Virus, Leadership Decentralized, Mortality, National Strategy, Pandemic, Personal Protective Equipment (PPE), Public Health, Public Opinion, Public Perception, Public Safety, Public Trust, Quarantine, Scientists, Social Distancing, Supply Chain • Leave a comment

https://www.healthcarefinancenews.com/news/us-reports-record-breaking-number-daily-covid-19-cases-experts-say-worst-has-yet-come

US coronavirus cases break global daily record, and experts warn - WRCBtv.com | Chattanooga News, Weather & Sports

Last Friday, the CDC reported 99,750 new cases, a record high from the day before.

The United States reported its highest number of new COVID-19 cases in a single day on Friday as cases across the country have been rising since mid-September, according to the Centers for Disease Control and Prevention’s COVID-19 data tracker.

Last Friday, the CDC reported 99,750 new cases, a record high from the day before when there were 90,155 new cases.

The overall national percentage of positive COVID-19 tests increased from 6.6% from the week ending on Oct. 17 to 7.1% for the week ending on Oct. 24, according to the CDC’s weekly surveillance summary.

WHAT’S THE IMPACT

With the spike in cases, the U.S. now has 9,182,628 total COVID-19 cases, with 565,607 of these coming in the last week.

Hospitalization rates have also increased since September, according to the CDC’s weekly COVID-19 summary. In the most recent report, the COVID-19-related hospitalization rate was about 200 hospitalizations per 100,000 population.

States that are being hardest hit with the most cases in the last week are Illinois (44,570), Texas (42,480), Wisconsin (32,506), California (28,505) and Florida (28,149).

While hospitals in surge areas of Texas, South and North Dakota, Utah and Wisconsin are reportedly overwhelmed, The New York Times reported that the death rate for seriously ill COVID-19 patients has declined. At one New York hospital system, the report said, where 30% of coronavirus patients died in March, the death rate dropped to 3% by the end of June.

Racial minorities continue to be harder hit by the pandemic; the hospitalization rate for Hispanic or Latino people was approximately 4.4 times that of non-Hispanic whites. The rate was 4.3 times higher for non-Hispanic American Indian or Alaska Native and 4.2 times higher for non-Hispanic Black individuals compared with non-Hispanic whites.

COVID-19 deaths in the U.S. have remained fairly consistent at 700 to 800 deaths per week since the beginning of September. The current death toll sits at 230,383, according to the CDC.

THE LARGER TREND

Congress has been unable to agree on legislation for more relief funding that might help hospitals, as the Coronavirus Aid, Relief and Economic Security Act did.

The recent surge in cases marks the country’s third and highest peak. Meanwhile, as other countries began locking down after their own increases in COVID-19 cases, President Trump criticized the preventative measures as “draconian.”

This is only the beginning of a new wave of COVID-19 cases, according to public health officials. Dr. Anthony Fauci, the nation’s leading infectious disease expert, told The Washington Post, “We’re in for a whole lot of hurt,” as the winter months come closer. Former FDA Commissioner Dr. Scott Gottlieb warned on CBS News’ “Face the Nation” that Thanksgiving is going to be the point where the country will begin to see “exponential growth in a lot of states,” with December likely being the hardest hit month.

With what hospitals and health systems learned from the first wave of COVID-19, ensuring their medical supply chains are intact and their telehealth offerings remain easy to use will be critical. Other strategies from the CDC include creating a written and structured COVID-19 plan that includes communication, triage and visitor protocols.

Facing a third-wave workforce crisis

Posted on by • Posted in 2020 Election Issues, Asymptomatic Transmission, Clinical Testing, Contact Tracing, Coronavirus, Crisis, Crisis Management, Economic Crisis, Economic Recovery, Elective Procedures, Elective Surgery, Infection Control, Infection Control Plan, Infectious Virus, Leadership Decentralized, Mortality, National Strategy, Nurses, Nurses Shortage, Pandemic, Public Health, Public Opinion, Public Perception, Public Safety, Public Trust, Quarantine, Recruiting, Retention, Scientists, Social Distancing, Supply Chain, Talent Management • Leave a comment

https://mailchi.mp/2480e0d1f164/the-weekly-gist-october-30-2020?e=d1e747d2d8

Optimizing Healthcare Workforce Management for High-Value Care

Over the past week, as coronavirus cases have spiked and COVID hospitalizations have grown to alarming levels, we’ve been keeping a close pulse on the situation at our member health systems in markets across the country.

Here’s what we can report: admissions are rising on a curve that looks increasingly vertical.

The ICU is less of a problem than inpatient beds, and while no one wants to cancel non-emergent procedures again, having just worked through the backlog of cases that were postponed in late spring and early summer, discussions about reallocating capacity are starting again. Some are considering shifting more surgeries to ambulatory centers, others are planning to dedicate more space to COVID-positive cases in an attempt to segregate the “hot zone”, and still others are exploring home-based care for certain medical admissions. Fortunately, the supply of PPE feels sufficient for the time being, as does testing capacity.
 
The number one concern among everyone we’ve talked to: staffing. Because of the high level of community spread, many are now losing nurses and other key staff to COVID isolation, with one system reporting that 35 percent of its critical care nurses at a key hospital had tested positive or were in quarantine after exposure. Staff are burned out, exhausted from the past eight months, and turnover rates are spiking. Because the third wave is so widespread, it’s become harder to find nurses from other markets who can temporarily relocate to help with a surge of cases. And the rates being charged for “agency” nurses—stopgap staff hired on a temporary basis—are going through the roof.

The staffing issue may prove to be the biggest crisis of the third wave of COVID, given how difficult it is to solve; there’s no Defense Production Act or National Guard supply chain for nurses. At best, hospitals will find themselves cobbling together a solution by cross-training staff, paying extra for temporary workers, and asking their already-overtaxed workforce to weather yet another storm. We’re eager to hear any creative approaches to solving the staffing challenge as winter approaches, and we’ve dedicated a senior member of our team to tracking the workforce crisis. Let us know what you’re seeing.

Healthcare executives fear for their organizations’ viability without a COVID-19 vaccine

Posted on by • Posted in 2020 Election Issues, Coronavirus, Credit Quality, Credit Ratings, Crisis, Crisis Management, Economic Crisis, Economic Recovery, Employee Benefits, Employee Furlough, Employee Hiring Freeze, Employee Layoffs, Employee Pay Cuts, Employee Protections, Employer-Based Health Insurance, Financial Viability, Financially Distressed, Health Insurance Coverage Adequacy, Health Policy, Health System, High Deductible Health Plans, High Drug Prices, High Premiums, High Prices, Hospital, Hospital Industry, Job, Job Loss, Job Market, Job Search, Job Security, Key Performance Indicators, Labor Spend Management, Labor Strike, Labor Union, Leadership, Leadership Culture, Leadership Flexibility, Leadership Implementation, Leadership Vision, Net Income, Nonoperating Income, Operating Expenses, Operating Income, Operating Margin, Operating Metrics, Operating Performance, Operating Revenue, Out of Pocket Expenses, Pandemic, Rev Cycle Management, Revenue Cycle, Strategic Change, Strategic Leadership, Strategic Plan, Strategy, Streamlining Operations, Supply Chain • Leave a comment

https://www.healthcarefinancenews.com/news/healthcare-executives-fear-their-organizations-viability-without-covid-19-vaccine

A complete financial recovery for many organizations is still far away, findings from Kaufman Hall indicate.

For the past three years, Kaufman Hall has released annual healthcare performance reports illustrating how hospitals and health systems are managing, both financially and operationally.

This year, however, with the pandemic altering the industry so broadly, the report took a different approach: to see how COVID-19 impacted hospitals and health systems across the country. The report’s findings deal with finances, patient volumes and recovery.

The report includes survey answers from respondents almost entirely (96%) from hospitals or health systems. Most of the respondents were in executive leadership (55%) or financial roles (39%). Survey responses were collected in August 2020.

FINANCIAL IMPACT

Findings from the report indicate that a complete financial recovery for many organizations is still far away. Almost three-quarters of the respondents said they were either moderately or extremely concerned about their organization’s financial viability in 2021 without an effective vaccine or treatment.

Looking back on the operating margins for the second quarter of the year, 33% of respondents saw their operating margins decline by more than 100% compared to the same time last year.

Revenue cycles have taken a hit from COVID-19, according to the report. Survey respondents said they are seeing increases in bad debt and uncompensated care (48%), higher percentages of uninsured or self-pay patients (44%), more Medicaid patients (41%) and lower percentages of commercially insured patients (38%).

Organizations also noted that increases in expenses, especially for personal protective equipment and labor, have impacted their finances. For 22% of respondents, their expenses increased by more than 50%.

IMPACT ON PATIENT VOLUMES

Although volumes did increase over the summer, most of the improvement occurred in areas where it is difficult to delay care, such as oncology and cardiology. For example, oncology was the only field where more than half of respondents (60%) saw their volumes recover to more than 90% of pre-pandemic levels.

More than 40% of respondents said that cardiology volumes are operating at more than 90% of pre-pandemic levels. Only 37% of respondents can say the same for orthopedics, neurology and radiology, and 22% for pediatrics.

Emergency department usage is also down as a result of the pandemic, according to the report. The respondents expect that this trend will persist beyond COVID-19 and that systems may need to reshape their business model to account for a drop in emergency department utilization.

Most respondents also said they expect to see overall volumes remain low through the summer of 2021, with some planning for suppressed volumes for the next three years.

RECOVERY MEASURES

Hospitals and health systems have taken a number of approaches to reduce costs and mitigate future revenue declines. The most common practices implemented are supply reprocessing, furloughs and salary reductions, according to the report.

Executives are considering other tactics such as restructuring physician contracts, making permanent labor reductions, changing employee health plan benefits and retirement plan contributions, or merging with another health system as additional cost reduction measures.

THE LARGER TREND

Kaufman Hall has been documenting the impact of COVID-19 hospitals since the beginning of the pandemic. In its July report, hospital operating margins were down 96% since the start of the year.

As a result of these losses, hospitals, health systems and advocacy groups continue to push Congress to deliver another round of relief measures.

Earlier this month, the House passed a $2.2 trillion stimulus bill called the HEROES Act, 2.0. The bill has yet to pass the Senate, and the chances of that happening are slim, with Republicans in favor of a much smaller, $500 billion package. Nothing is expected to happen prior to the presidential election.

The Department of Health and Human Services also recently announced the third phase of general distribution for the Provider Relief Fund. Applications are currently open and will close on Friday, November 6.

Former Tennessee hospital manager charged with stealing nearly $800K in supplies

Posted on by • Posted in Embezzlement, Employee Theft, Health System, Hospital, Hospital Industry, Internal Audit, Internal Control, Inventory, Inventory Control, Supply Chain • Leave a comment

https://www.beckershospitalreview.com/supply-chain/former-tennessee-hospital-manager-charged-with-stealing-nearly-800k-in-supplies.html?utm_medium=email

Employee Theft Quotes. QuotesGram

A former worker at Maury Regional Medical Center in Columbia, Tenn., was charged with stealing nearly $800,000 worth of medical supplies from the hospital and selling them online for his personal benefit, Williamson Source reported. 

Former system coordinator Tommy John Riker allegedly stole $798,265 worth of supplies from the hospital between 2017 and 2019. He worked in the hospital’s supply chain department and was responsible for purchasing and managing items in the hospital’s inventory control system.

His job allowed him to steal items from the hospital’s inventory and manipulate the inventory to make it seem the supplies were given to staff, according to investigators from Tennessee’s Comptroller’s Office, the Williamson Source reported. 

The stolen supplies include needles, wound dressings and surgical dressings, according to the comptroller’s report. 

Mr. Riker was indicted on one count of theft over $250,000 and 54 counts of money-laundering.

Read the full article here.