Author Archives: henrykotula

How Merck’s antiviral pill could change the game for COVID-19

Posted on by • Posted in Antiviral Pill, Clinical Research, Clinical Testing, Coronavirus, Coronavirus Delta Variant, Coronavirus Mutation, Coronavirus Treatment, Molnupiravir, Side Effects • Leave a comment

https://www.nationalgeographic.com/science/article/how-mercks-antiviral-pill-could-change-the-game-for-covid-19?cmpid=org=ngp::mc=crm-email::src=ngp::cmp=editorial::add=SpecialEdition_20211001::rid=C1D3D2601560EDF454552B245D039020

Coronavirus: 'Game-changing' oral pill molnupiravir reduces COVID-19 hospitalisations by half in trial | Newshub

A new drug by Merck significantly reduces the risk of hospitalization and death in people who take it early in the course of their COVID-19 illness, according to the interim results of a major study released today. It is the first oral antiviral found to be effective against this coronavirus.

People who took this drug, called molnupiravir—four pills twice a day for five days—within five days of showing symptoms were about half as likely to be hospitalized as those taking the placebo. They were also less likely to die, with eight deaths in the placebo group reported within a month of treatment and none in those who received the medicine.

“Having a pill that would be easy for people to take at home would be terrific. If this was available through a drug store, more people could get it,” says Albert Shaw, an infectious diseases specialist at Yale Medicine in New Haven, Connecticut, who was not involved with the research. All of the antiviral medicines available today, including remdesivir and the monoclonal antibodies, must be administered through an IV in a medical setting. Monoclonal antibodies are much more effective against COVID-19 and cut the risk of hospitalization and death by up to 85 percent, but this treatment costs almost three times as much as molnupiravir.

How the antiviral works

Antiviral drugs are used against many viruses, including for herpes and the flu. These drugs take advantage of the fact that viruses need to replicate inside a person’s cells in order to sicken them. Antivirals stop the replication process so the illness doesn’t progress.

The Merck drug works by introducing RNA-like building blocks into the virus’s genome as it multiplies, which creates numerous mutations, disrupts replication, and kills the virus.

Keeping the virus from multiplying is important because the more it replicates, destroying cell after cell, the sicker a person usually becomes, says Waleed Javaid, an epidemiologist and director of infection prevention and control at Mount Sinai Downtown in New York, who was not involved in the study. Additionally, when enough virus is inside the body the immune system may go into overdrive. “At a certain point the body detects a virus it has never seen and will throw everything against it, like a tank coming at a small target.” he says. This helps the body eliminate the virus but can cause sometimes deadly collateral damage throughout the body in its wake.

The research, which was conducted in numerous sites around the world, was stopped early because the results were so promising, Merck says. The drug was even effective against variants like Delta and Mu. Based on this interim analysis in 775 people, the company plans to submit an application for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration as well as regulatory bodies in other countries in hopes the drug can be made available. When that will happen is not clear, but the U.S. government has already agreed to purchase 1.7 million courses of treatment at $700 each, Merck notes.

Who can get the drug?

It’s also not known who would ultimately be authorized to take the medicine. The study included only people who were sick and unvaccinated and had at least one risk factor for developing a severe case of COVID-19, says Aaron Weinberg, national director of clinical research at Carbon Health, a for-profit provider of primary and urgent care, and a principal investigator of the study. This includes people who are older than 60, obese, immunocompromised from another condition, or have underlying heart or pulmonary disease, among others.

If the FDA does authorize the drug, it could limit who gets it to people like those in the research, Javaid says.

Although this drug looks promising, it’s a treatment but not a prophylactic like the vaccine. The medicine does not negate the need for unvaccinated people to get their shot, Shaw says. Some people taking the pills still got sick enough to be hospitalized. And while side effects in this study were mild—generally gastrointestinal issues, Weinberg says, and at comparable rates in the treatment and placebo groups—safety issues might emerge when the drug is given more broadly, Shaw says. Meanwhile, hundreds of millions of people have already gotten the vaccines with no major consequences.

Still, the results of this study should be celebrated, Javaid says. “Saving eight lives is huge, as is halving hospitalization,” he says. Perhaps another drug being studied will later prove to be more effective, reducing hospitalization by 80 or even 100 percent, he says. “But this is better than any oral antivirals we have right now, which is none,” he says.

Air Ambulance Costs Are Soaring

Posted on by • Posted in Air Ambulance, Airline Deregulation Act of 1978, Health Insurance Coverage Adequacy, Health Policy, Helicopter Transport, Medicare, No Surprises Act, Out of Network, Out of Pocket Expenses, Surprise Bills • Leave a comment
https://www.medpagetoday.com/special-reports/exclusives/94818?xid=nl_mpt_DHE_2021-10-05&eun=g885344d0r&utm_source=Sailthru&utm_medium=email&utm_campaign=Daily%20Headlines%20Top%20Cat%20HeC%20%202021-10-05&utm_term=NL_Daily_DHE_dual-gmail-definition

Air ambulance transport costs have skyrocketed in recent years, according to a new report from FAIR Health.

Notably, the average estimated in-network allowed amount for air ambulance transport increased 76.4%, from $8,855 in 2017 to $15,624 in 2020.

The jump was part of a general rise in costs for both airplane and helicopter air ambulance transport during this time period, FAIR Health said, which included increases in charge amounts (the amount charged to a patient who is uninsured or obtaining an out-of-network service), estimated in-network allowed amounts for privately insured patients (the total fee negotiated between an insurance plan and a provider for an in-network service), and Medicare reimbursement amounts.

The average charges associated with a fixed-wing air ambulance rose 27.6%, from $19,210 in 2017 to $24,507 in 2020, according to the report, and the average Medicare reimbursement amount increased by 4.7%, from $3,071 to $3,216.

For helicopter transport, the average charges associated with a rotary-wing air ambulance rose 22.2%, from $24,924 in 2017 to $30,446 in 2020. The average estimated in-network allowed amount increased 60.8%, from $11,608 to $18,668, and the average Medicare reimbursement amount again rose 4.7%, from $3,570 to $3,739.

“Air ambulance services have been the subject of substantial policy focus,” said Robin Gelburd, president of FAIR Health, in a statement. “We hope that this study of air ambulance transport proves productive to policy makers, researchers, payors, providers, and consumers seeking to better understand this corner of the healthcare system.”

FAIR Health’s report also found that air ambulance claims increased 30% from 2016 to 2020 (0.7% to 0.9%) as a percentage of all ambulance (ground and air) claims.

In 2020, the most common diagnoses associated with fixed-wing air ambulance transport were chronic respiratory diseases, including chronic obstructive pulmonary disease and chronic respiratory failure, and the second most common was COVID-19, which accounted for 7% of fixed-wing air ambulance claims.

Because air ambulance transport is often used for patients in life-threatening situations, they generally have no control over type of transport or provider used, FAIR Health said. As a result, surprise bills occur frequently.

A number of states have made efforts to regulate air ambulance charges, but these attempts have been overturned by court rulings that state that such efforts are preempted by the Airline Deregulation Act of 1978, the report noted.

However, the federal No Surprises Act, signed into law in December 2020, contained provisions to protect consumers from surprise bills, including those from out-of-network air ambulance service providers.

On September 30, HHS held a press call on one of its surprise billing rules, which would require companies to give patients “good faith estimates” of charges upfront and to submit a dispute resolution for out-of-network surprise bills.

Asked by MedPage Today whether air ambulances would be included, a senior administration official responded, “Yes, air ambulances are covered by this rule. They will go through a very, very similar independent dispute resolution process [as other providers]. I think the only thing different about the air ambulance process is the list of allowable information that the parties can bring to be considered in addition to the qualifying amount.”

Stark divide in industry outlook

Posted on by • Posted in Employee, Employee Burnout, Employee Morale, Employee Motivation, Employee Optimism, Health System, Hospital, Hospital Industry, Labor Shortages, Recruiting, Talent Identification, Talent Imperative, Talent Management • Leave a comment
https://www.axios.com/newsletters/axios-vitals-a98b0e1e-c299-4587-98db-69447c57d51b.html?utm_source=newsletter&utm_medium=email&utm_campaign=newsletter_axiosvitals&stream=top

Nearly three in five U.S. health care workers are optimistic about where the industry is headed, according to a new poll released today by Morning Consult.

Why it matters: Amid increasing concerns about burnout in health care and workforce shortages, the poll of more than 900 workers between Sept. 2–8 shows there is still a lot of optimism about the health care profession even as workers deal with stressful working conditions.

A common theme among the responses was the message that “working in healthcare is hard and it’s something that should only be done if you are completely committed to it.”

  • Responses ranged from one worker who said “it’s a great career,” to another who said young people should avoid the field “unless you have a death wish.”
  • The poll also found men were more likely than women to be optimistic about the future of the health care industry.

U.S. hits 700,000 COVID deaths

Posted on by • Posted in Coronavirus, Coronavirus Delta Variant, Coronavirus Mutation, Infection Control, Infection Control Plan, Infectious Virus, Mortality, Pandemic, Public Health, Public Opinion, Public Perception, Public Safety, Public Schools, Public Trust, Unvaccinated, Vaccination, Vaccine, Vaccine Efficacy, Vaccine Hesitancy Rate, Vaccine Safety, Vaccine Skepticism, Vaccine Supply • Leave a comment

https://www.axios.com/covid-deaths-700000-us-6dd0223d-562a-41b9-a780-ef54e646b07e.html

The U.S. surpassed 700,000 deaths from the coronavirus on Friday, according to data from Johns Hopkins University.

Why it matters: A summer of division over vaccine and masking mandates only added to the surge in cases caused by the Delta variant. The U.S. went from 600,000 deaths to 700,000 in the span of three-and-a-half months.

  • Public health experts have become increasingly frustrated as the “pandemic of the unvaccinated” spread across the country.
  • Roughly 70 million eligible Americans remain unvaccinated, AP reports.

GOP targets Dems with “Medicscare” ads

Posted on by • Posted in Competition, Fear, Health Insurance Coverage Adequacy, Health Policy, High Deductible Health Plans, High Drug Prices, High Premiums, High Prices, Medicare, Medicare Drug Price Negotiation, Medicare Part D, Mediscare Ads, Partisanship, Pharmaceutical Industry • Leave a comment

https://www.axios.com/gop-targets-dems-with-medicscare-ads-abc27c8c-f2d2-4e3d-9d4b-40a5552d4444.html

Conservative and industry groups are trying to whip up opposition to President Biden’s massive social spending plan by warning it will imperil Medicare benefits, Axios has learned.

Why it matters: “Medicscare” is a well-worn political tactic precisely because it can be effective. For Democrats, there’s zero room for defections against the $3.5 trillion proposal if they want to pass the bill.

What’s happening: Senior citizens in Arizona, represented by Sen. Kyrsten Sinema (D-Ariz.), potential Democratic holdout, have started receiving large boxes labeled “Medical Shipment. Please open immediately.”

  • Inside, they find an empty prescription drug bottle and literature warning of Democratic plans to “ration Medicare Part D.” That’s a reference to a budget reconciliation bill provision that would allow the government to negotiate Medicare reimbursement rates for prescription drugs.
  • The mailers are the work of the Common Sense Leadership Fund, a Republican-aligned advocacy group. The mailers in Arizona specifically target Sen. Mark Kelly (D-Ariz.), who’s up for re-election next year.
  • CSLF spokesman Colin Reed told Axios the group is mailing the packages to seniors and unaffiliated voters in Arizona and New Hampshire, where the group is targeting Sen. Maggie Hassan (D-N.H.), who’s also up for re-election.

Another nonprofit advocacy group, A Healthy Future, is targeting the prescription drug portions of the bill in a digital ad campaign aimed at key Democratic votes.

  • The group has spent nearly $300,000 on Google, Facebook and Instagram ads aimed at Reps. Frank Pallone, Tom Malinowski and Andy Kim, all Democrats from New Jersey — where the drug industry has a huge economic footprint.
  • “This is a prescription for disaster,” its ads say. They urge calls to Congress to “oppose cutting Medicare to pay for the $3.5 trillion spending plan.”
  • It’s not clear who’s behind A Healthy Future — the group did not respond to inquiries from Axios — but its messaging on reconciliation and past policy fights track with drug industry priorities.

The big picture: Democrats have turned to drug pricing reforms to offset part of the legislation’s massive price tag, potentially paying for as much as $600 billion in new spending.

  • That’s drawn intense opposition from the pharmaceutical industry — and lawmakers who enjoy the industry’s backing.
  • If it’s included in the final version of the legislation, it could be a major sticking point for groups looking to peel off wobbly Democratic votes.
  • Sinema has already said she opposes the effort.

Yes, but: The Mediscare tactic is larger than just the drug pricing fight. Americans for Prosperity, the Koch-backed conservative advocacy group, is running its own ads warning of much larger impending Medicare cuts.

  • It says the spending bill’s efforts to expand Medicare will imperil the program itself.
  • “Medicare is set to go bankrupt in about four years,” the ads claim. “Congress is acting irresponsibly and putting the program in jeopardy.”
  • AFP’s ads have touched on drug pricing as well, which it’s dubbed “a 95% drug tax to fund $3.5 trillion in wasteful spending.”

Coronavirus vaccine mandates are working — for now

Posted on by • Posted in Coronavirus, Coronavirus Delta Variant, Coronavirus Mutation, Infection Control, Infection Control Plan, Infectious Virus, Public Health, Public Opinion, Public Perception, Public Safety, Public Schools, Public Trust, Unvaccinated, Vaccination, Vaccine, Vaccine Efficacy, Vaccine Hesitancy Rate, Vaccine Mandate, Vaccine Mandatory, Vaccine Safety, Vaccine Skepticism, Vaccine Supply • Leave a comment
https://www.axios.com/newsletters/axios-vitals-a98b0e1e-c299-4587-98db-69447c57d51b.html?utm_source=newsletter&utm_medium=email&utm_campaign=newsletter_axiosvitals&stream=top

Coronavirus vaccine mandates imposed by employers seem to be working so far, suggesting that most vaccine holdouts would rather get the shot than lose their job, Axios’ Caitlin Owens writes.

Why it matters: Every vaccine helps in our fight against the coronavirus, although the U.S. still has a long way to go.

Driving the news: States with vaccine mandates for health care workers that have taken effect, like California and New York, have seen a large uptick in vaccinations.

  • These, of course, are blue states and have higher vaccination rates to begin with. But some health systems in red states, like Texas, have seen similar results when their mandates took effect.
  • High-profile mandates outside of the health care sector have also been successful. For instance, United Airlines achieved nearly 100% vaccination among its employees, and Tyson Foods announced that more than 90% of its workers are now vaccinated.
  • The Biden administration announced that it will require all employers with 100 or more employees to ensure their workers are vaccinated or tested weekly, but this hasn’t yet been implemented.

Yes, but: Hospitals and long-term care facilities are already stretched so thin that it won’t take a mass exodus for them to feel the effects of layoffs.

  • In New York, Gov. Kathy Hochul signed an executive order last week to help provide relief to health systems struggling with staff shortages.
  • The Biden administration announced nursing home workers will soon be required to be vaccinated, which could be a much tougher lift. Only about two-thirds of nursing home staff are vaccinated.

What they’re saying: “As we get down to the harder core unvaccinated who are more resistant, what we are seeing is that reality is a more powerful tool to change behavior than information and messaging,” said Drew Altman, president and CEO of KFF.

AMA report: U.S. has “highly concentrated” payer markets that stifle competition  

Posted on by • Posted in ACA, America's Health Insurance Plans (AHIP), American Medical Association (AMA), Competition, Federal Trade Commission (FTC), Health Insurance Coverage Adequacy, Health Insurance Industry, Health Policy, High Deductible Health Plans, High Drug Prices, High Premiums, High Prices, Market Consolidation, Market Failure, Market Power, Market Share, Market Trends, Mergers & Acquisitions, Monopoly, Monopoly Behavior, Out of Network, Out of Pocket Expenses, Surprise Bills • Leave a comment

https://medcitynews.com/2021/10/ama-report-u-s-has-highly-concentrated-payer-markets-that-stifle-competition/?utm_campaign=MCN%20Daily%20Top%20Stories&utm_medium=email&hsmi=166812730&_hsenc=p2ANqtz–Z_7y9-ZOPkhC7HI4RXSwuM5xDzd2B0uZi9sApeW1J89hQBktG-rqujxpBFiXmxEEnaK77vlq-7vHhr-qK8mxRgBmwA&utm_content=166812730&utm_source=hs_email

About 73% of health insurance markets are highly concentrated, and in 46% of markets, one insurer had a share of 50% or more, a new report from the American Medical Association shows. The report comes a few months after President Joe Biden directed federal agencies to ramp up oversight of healthcare consolidation.

The majority of health insurance markets in the U.S. are highly concentrated, curbing competition, according to a report released by the American Medical Association.

For the report, researchers reviewed market share and market concentration data for the 50 states and District of Columbia, and each of the 384 metropolitan statistical areas in the country.

They found that 73% of the metropolitan statistical area-level payer markets were highly concentrated in 2020. In 91% of markets, at least one insurer had a market share of 30%, and in 46% of markets, one insurer had a share of 50% or more.

Further, the share of markets that are highly concentrated rose from 71% in 2014 to 73% last year. Of those markets that were not highly concentrated in 2014, 26% experienced an increase large enough to enter the category by 2020.

In terms of national-level market shares of the 10 largest U.S. health insurers, UnitedHealth Group comes out on top with the largest market share in both 2014 and 2020, reporting 16% and 15% market share, respectively. Anthem comes in second with shares of 13% in 2014 and 12% in 2020.

But the picture looks different when it comes to the market share of health insurers participating in the Affordable Care Act individual exchanges. In 2014, Anthem held the largest market share among the top 10 insurers on the exchanges, with a share of 14%. By 2020, Centene had taken the top spot, with a share of 18%, while Anthem had slipped to fifth place, with a share of just 4%.

Another key entrant into the top 10 list in 2020 was insurance technology company Oscar Health, with 3% of the market share in the exchanges at the national level.

“These [concentrated] markets are ripe for the exercise of health insurer market power, which harms consumers and providers of care,” the report authors wrote. “Our findings should prompt federal and state antitrust authorities to vigorously examine the competitive effects of proposed mergers involving health insurers.”

The payer industry hit back. In a statement provided to MedCity News, America’s Health Insurance Plans, a national payer association, said that Americans have many affordable choices for their coverage, pointing to the fact that CMS announced average premiums for Medicare Advantage plans will drop to $19 per month in 2022 from $21.22 this year.

“Health insurance providers are an advocate for Americans, fighting for lower prices and more choices for them,” said Kristine Grow, senior vice president of communications at America’s Health Insurance Plans, in an email. “We negotiate lower prices with doctors, hospitals and drug companies, and consumers benefit from lower premiums as a result.”

Further, the report does not mention the provider consolidation that also contributes to higher healthcare prices. Mergers and acquisitions among hospitals and health systems have continued steadily over the past decade, remaining relatively impervious to even the Covid-19 pandemic.

Scrutiny around consolidation in the healthcare industry may grow. In July, President Joe Biden issued an executive order urging federal agencies to review and revise their merger guidelines through the lens of preventing patient harm.

The Federal Trade Commission has already said that healthcare businesses will be one of its priority targets for antitrust enforcement actions.