Ivermectin's Days in Court

 On May 4, 2021, MedPage Today first reported on an Illinois judge's order for a hospital to give ivermectin to a comatose COVID-19 patient. As part of our review of the year's top stories, we look back on what has happened since this decision and the numerous cases that followed in its wake.

At the beginning of 2021, the anti-parasitic medication ivermectin took off in popularity as a treatment for COVID-19 after a campaign from the physicians at the helm of the Front Line COVID-19 Critical Care Alliance (FLCCC) touted its efficacy. Despite lack of evidence and recommendations against its use from the CDC, FDA, and NIH, some doctors and family members of COVID patients have taken the issue to court, suing hospitals that have refused to administer ivermectin in serious COVID cases.

New York

The first of these cases cropped up in January 2021, when a judge ordered Millard Fillmore Suburban Hospital in Buffalo, New York, to give ivermectin to 80-year-old Judith Smentkiewicz. She had been on a ventilator battling COVID-19 when her family members pleaded with one of the hospital's physicians to try ivermectin. Smentkiewicz received her first dose before another doctor at the hospital refused to continue the treatment.

Smentkiewicz's family maintained that even the first dose of the experimental drug made rapid improvements to her condition, which subsequently declined after the second dose was refused. The hospital insisted that doctors -- not the courts -- should be at the forefront of these decisions. State Supreme Court Judge Henry Nowak, however, went the way of Smentkiewicz's family members.

It is reported that Smentkiewicz recovered after resuming her treatments, but the connection between ivermectin and her turnaround remains unclear. Some clinicians have argued that patients might just be getting better, with or without this particular drug.

Illinois

The same was seen in May 2021, when Judge James Orel, of DuPage County, Illinois, ordered Edward-Elmhurst Hospital to allow 68-year-old Nurije Fype to receive ivermectin as a treatment for her acute COVID illness.

Fype's daughter, Desareta, learned of the drug after reading about Smentkiewicz's situation months prior. When her own mother was placed on a ventilator, she sought out ivermectin. Doctors refused, given the drug's experimental status for COVID-19 and potential side effects, including nausea, vomiting, diarrhea, sudden drops in blood pressure, and liver injury.

Bending to the judge's orders, the hospital granted internist Alan Bain, MD, credentials to give Fype ivermectin. According to some reports, she was discharged from the hospital after her condition improved. Still, whether ivermectin was what prompted Fype's recovery has yet to be proven.

In September 2021, the American Medical Association (AMA) issued a statement strongly opposing the use of ivermectin to treat COVID-19, adding that "calls to poison control centers due to ivermectin ingestion have increased five-fold from their pre-pandemic baseline."

Not all of the legal battles against hospitals in the fight for ivermectin have been successful, though. In September, MedPage Today reported that a judge sided in favor of Memorial Medical Center in Springfield, Illinois, which stood firmly against allowing ivermectin treatments for COVID patients. Anita Clouse, wife of 61-year-old Randy Clouse, took to the courts to force Memorial Medical Center to give her husband ivermectin.

Randy Clouse, who wasn't vaccinated against COVID-19, was on a ventilator and dialysis as a result of his COVID infection, the State Journal-Register reported. But in a legal response, the hospital said that Clouse's condition was improving at the time of their filing and he no longer had an active COVID diagnosis.

Chicago internist Bain had prescribed ivermectin to Clouse and testified in a hearing for the case. The lawyer representing the Springfield hospital maintained that Bain did not properly review Clouse's medical history before prescribing the drug and that he refused to acknowledge the widespread medical advice regarding the use of ivermectin for COVID-19 patients.

Attorney Ralph Lorigo, who represented Clouse and a number of other patients, told MedPage Today that, as of Nov. 3, Clouse was taken off the ventilator and later discharged from the hospital.

Lorigo also represented Man Kwan Ng, the daughter of 71-year-old Sun Ng, in a case against Edward Hospital in Naperville, Illinois. Sun Ng ended up on a ventilator with COVID-19 in mid-October, the Chicago Tribune reported. Despite the hospital's refusal to turn to ivermectin -- citing the same safety and efficacy concerns as health officials -- a DuPage County Judge ruled that Bain, who is unvaccinated, could prescribe Ng with ivermectin.

According to the Daily Herald, Lorigo said Ng removed his breathing tube himself after 5 days of ivermectin treatment. The lawyer for Edward Hospital, however, said Ng was improving before the treatment even started.

Ohio

At the beginning of September, what at first looked like a win for ivermectin proponents turned out to be a loss in the case of Julie Smith, who filed suit against West Chester Hospital, located near Cincinnati, to allow the use of ivermectin after her husband, Jeffrey Smith, 51, was placed on a ventilator and diagnosed with a secondary infection, the Ohio Capital Journal reported.

Although a Butler County judge originally ruled in favor of the Smith family against the hospital's wishes, the ruling was flipped a week later by a different judge after physicians told the court that ivermectin was not helping Smith get better, NPR reported.

Fred Wagshul, MD, who is affiliated with the Front Line COVID-19 Critical Care Alliance, had prescribed ivermectin to Smith before the hospital's refusal. At the follow-up hearing, Wagshul testified that he wasn't sure if the drug would help Smith, ultimately convincing the judge to reverse the order.

"After considering all of the evidence presented in this case, there can be no doubt that the medical and scientific communities do not support the use of ivermectin as a treatment for COVID-19," Judge Michael Oster ruled.

According to reports, Smith died a few weeks later.

Kentucky

In a similar decision from mid-September, Jefferson Circuit Court Judge Charles Cunningham overruled a previous ruling from a different judge, ultimately permitting a hospital to deny the prescription of ivermectin to a COVID patient.

Angela Underwood had filed a suit against Norton Brownsboro Hospital in Louisville, Kentucky, claiming that the hospital prohibited one of its physicians from administering ivermectin to her husband, Lonnie, 58, despite a previous agreement.

"[The internet] is rife with the ramblings of persons who spout ill-conceived conclusions if not out-right falsehoods," Cunningham said, according to a report by the Washington Post. "If [Angela Underwood] wants to ask the Court to impose her definition of 'medically indicated' rather than the hospital's, she needs to present the sworn testimony of solid witnesses, espousing solid opinions, based on solid data."

https://www.medpagetoday.com/special-reports/exclusives/96447

Vir: New Research Describes Structure of SARS-CoV-2 Omicron Immune Evasion, Receptor Engagement

– Growing body of evidence validates Vir’s approach of targeting a highly conserved region of the spike protein –

– Together with recent pseudo- and live virus results, additional preclinical data reinforce sotrovimab retains in vitro neutralizing activity against all known variants of concern, including the highly divergent Omicron variant –

https://www.biospace.com/article/releases/vir-biotechnology-announces-new-research-describing-the-structural-basis-of-sars-cov-2-omicron-immune-evasion-and-receptor-engagement/

Missouri to lift COVID-19 state of emergency

 Missouri Gov. Mike Parson (R) has lifted the state’s COVID-19 state of emergency for the first time since March 2020. 

"Thanks to the effectiveness of the vaccine, widespread efforts to mitigate the virus, and our committed health care professionals, past needs to continue the state of emergency are no longer present," Parson said in a statement on Thursday.

"Over the last 22 months, we have coordinated with local, state, and private partners to mitigate COVID-19 and work towards returning to normalcy. We all now know how to best fight and prevent serious illness from this virus. The State stands ready to provide assistance and response, but there is no longer a need for a state of emergency."

Parson previously extended the state’s COVID-19-related state of emergency five times before issuing the final executive order for health care needs in August. 

According to the statement, all of the state’s remaining COVID-19 related waivers authorized under EO 21-09 will be terminated on Dec.31. 

Also, all state agencies, boards, commissions, and departments are allowed to pursue rule-making if permanent changes to regulations are needed after Dec.31  to improve long-term outcomes for residents, healthcare facilities, and businesses. 

"In Missouri, we never had mandates or forced lockdowns," Parson said. "The main focus of our state of emergency was to provide regulatory flexibility to support and assist Missourians, health care facilities, and businesses and coordinate a COVID-19 response that saved lives and livelihoods.” 

“We encourage all Missourians to consider COVID-19 vaccination and to stay diligent, but we can work together to fight COVID-19 while living our normal lives. It is time to take this final step and move forward as a state."

The U.S. is currently dealing with a winter surge of COVID-19 infections as the omicron variant has taken hold across the nation.

State authorities have administered over 565,000 vaccine doses with 42 percent of residents being a part of a primary vaccine series.

Nearly 94 percent of state residents over the age of 65 have received one dose of the vaccine and 62 percent of residents have chosen to get vaccinated against the virus, according to the statement.

https://thehill.com/homenews/state-watch/587845-missouri-to-lift-covid-19-state-of-emergency

Spirit to double pay for flight attendants through Jan. 4

 Spirit Airlines flight attendants will receive double play on any work through Jan.4, Reuters reported, as airline carriers struggling to keep their flight schedule intact due to mass cancellations caused largely by pandemic-fueled worker absences.

According to FlightAware.com, there have been over 8,000 flight cancellations over the past eight days. 

"All flight attendants, regardless of how you have obtained your pairing, will be receiving 200% pay for any pairing that touches Dec. 28 through Jan. 4," the Association of Flight Attendants-CWA said in a statement.

The Association of Flight Attendants-CWA union represents about 4,00 Spirit flight attendants, according to the airline’s latest filing. 

Earlier this year, Florida-based Spirit Airlines had to cancel nearly 3,000 flights due to bad weather and staffing shortages, Reuters reported. 

Major airlines including SkyWest Airlines, Alaska Air Group, and JetBlue Airways have all cited the spread of the omicron variant and weather as the reasons for the vast majority of delays and cancellations, Reuters noted.

https://thehill.com/policy/transportation/aviation/587846-spirit-to-double-pay-for-flight-attendants-through-jan-4

Federal judge blocks mask and vaccine mandates for Texas Head Start program

 A federal judge blocked mask and vaccine mandates in the state's Head Start program in a ruling on Friday, which Gov. Greg Abbott quickly hailed as an example of his state earning a victory over the Biden administration.

"The Court concludes that the circumstances do not justify or require a nationwide injunction,” the ruling by Judge James "Wesley" Hendrix said, KLBK Lubbock reported. “…The great majority of evidence before the Court is limited to harm caused to Head Start programs in Texas."

Hendrix is a Trump appointee who took his position in 2019.Lubbock Independent School District (LISD) and the state of T

exas sued the Biden administration earlier this month to temporarily block the mandates for the Head Start program from going into effect nationwide, but the judge restricted the order to only apply to Texas, KLBK reported.

LISD and Texas's attorney general argued that mask and vaccine mandates negatively impact the Head Start program, which provides educational assistance to children from low-income families, according to KLBK. LISD officials claimed that staff might be forced to quit as a result of the mandates, and low-income parents might take their kids out of the district's schools. 

Abbott (R) reacted to the ruling in a tweet, writing that "Texas just beat Biden again."

BREAKING: Texas just beat Biden again.

Another of Biden’s vaccine & mask mandates was just halted by a federal judge in Texas.

The Court writes: “It is undisputed that an agency cannot act without Congressional authorization.”

That would apply to all of Biden’s orders. pic.twitter.com/dqmDLGxR9j

 

— Greg Abbott (@GregAbbott_TX) January 1, 2022

Abbott has been an avid opponent of mask and vaccine mandates. In October he issued an executive order banning vaccine mandates by any “entity in Texas,” including private businesses, which directly conflicted with Biden's federal vaccine mandate for businesses with 100 or more workers. 

Hendrix's ruling is preliminary and the lawsuit will go on in federal court, KLBK noted. 

https://thehill.com/homenews/state-watch/587847-federal-judge-blocks-mask-and-vaccine-mandates-for-texas-head-start

Biotech Investors: Mark Your Calendar For January PDUFA Dates

 Regulatory decisions by the U.S. Food and Drug Administration in December turned out to be mostly positive. Among the treatment options that were greenlighted in the month were two new molecular entities.

The number of new molecular entities approved is considered an indicator of innovation that is occurring in the drug industry. With the year almost grinding to a close, NME approvals total 48 compared to the 53 NMEs that received the nod in 2020.

Here are the key PDUFA dates scheduled for January.

Click here to access Benzinga's FDA Calendar

Xeris Awaits Approval Of Acquired Cushing's Syndrome Drug

• Company: Xeris Biopharma Holdings, Inc. 
  XERS +20.58%
   (Get Free Alerts for XERS)
• Type of Application: NDA
• Candidate: Recorlev (levoketoconazole)
• Indication: endogenous Cushing's syndrome.
• Date: Jan. 1

Recorlev came into Xeris's fold through its acquisition of Strongbridge Biopharma, which was announced in May.

Recorlev is an investigational adrenal steroidogenesis inhibitor in development for the treatment of patients with endogenous Cushing's syndrome. Cushing's syndrome is a rare but serious and potentially lethal endocrine disease caused by chronic elevated cortisol exposure, which is often the result of a benign tumor of the pituitary gland.

The NDA filed by Strongbridge was accepted for review in May 2021.

Can Eon's Epilepsy Clear FDA Hurdle After Initial Hiccups?

• Company: Eton Pharmaceuticals, Inc. 
  ETON +0.23%
   (Get Free Alerts for ETON)
• Type of Application: NDA
• Candidate: zonisamide oral suspension
• Indication: epilepsy
• Date: Jan. 29

The NDA for zonisamide oral suspension for the treatment of partial seizures in patients with epilepsy was accepted for review in Oct. 2020, with a PDUFA date of May 29. Eton announced in February that it has sold its neurology portfolio, including lamotrigine, zonisamide and topiramate to privately held Azurity Pharma for up to $45 million, including upfront and milestone payments.

The application was hit with a complete response letter and subsequently, Azurity filed a response to the FDA's communication in August following which a new PDUFA goal date was announced.

Eton will receive a $5-million milestone payment upon the approval and launch of zonisamide.

In a mid-November update, Eton said it believes the only item holding up FDA approval of the zonisamide oral suspension product application is the FDA inspection of the product's European manufacturer.

‘Go' or ‘No-Go' For Roche Retinal Disorder

• Company: Roche Holding AG (Pink: RHHBY)
• Type of Application: biologic license application
• Candidate: faricimab
• Indication: retinal disorders
• Date: Jan. 29 (estimated)

The FDA accepted the BLA for faricimab for priority review on July 29 as a treatment option for wet age-related macular degeneration and diabetic macular edema. Assuming a six-month review period, a decision could be expected in late January.

Faricimab is a bispecific antibody targeting the vascular endothelial growth factor and angiopoietin 2 pathways.

Regeneron/Sanofi Seek Label Expansion For Cancer Drug Libtayo

• Company: Regeneron Pharmaceuticals, Inc. 
  REGN -1.71%
   and Sanofi 
  SNY -0.63%
• Type of Application: supplemental BLA
• Candidate: Libtayo
• Indication: cervical cancer.
• Date: Jan. 30

Regeneron's application seeking expanding the label of Libtayo to treat patients with recurrent or metastatic cervical cancer whose disease progressed on or after chemotherapy was accepted for priority review on Sept. 28. Libtayo is a fully human monoclonal antibody targeting the PD-1 immune checkpoint receptor on T-cells. It currently has been approved three indications, involving difficult to treat cancers.

Can Pfizer Snag Approval For Pediatric Growth Hormone Deficiency Treatment?

• Company: Pfizer, Inc. 
  PFE +1.06%
  /OPKO Health, Inc. 
  OPK -0.62%
• Type of Application: BLA
• Candidate: Somatrogon
• Indication: pediatric patients with growth hormone deficiency
• Date: January

Somatrogon is an investigational new biologic product, which is being co-developed by Pfizer and OPKO under a 2014 agreement. Under the agreement, OPKO is responsible for conducting the clinical program and Pfizer is responsible for registering and commercializing the product.

The investigational asset is a once-weekly, long-acting recombinant human growth hormone, for the treatment of growth hormone deficiency in pediatric patients.

The application was accepted for review in January with a PDUFA date in October. Later in late September, Pfizer said the FDA communicated a three-month extension in the review period to January.

https://www.benzinga.com/general/biotech/21/12/24733823/attention-biotech-investors-mark-your-calendar-for-january-pdufa-dates

FDA Maintains PCR Tests Are 'Gold Standard' Despite CDC Dropping Over Positive Results 'Up To 12 Weeks'

 On Wednesday, CDC Director Rochelle Walensky defended the agency's decision to eliminate PCR testing at the end of a Covid infection as part of its recommended guidelines, because the tests can 'stay positive for up to 12 weeks.'

In other words, as Yossi Gestetner points out, "This means that for the past 21 months, people sat home for extra days and weeks because their test came back with an irrelevant positive."

The FDA, however, which called the tests the "gold standard" in a July PolitiFact "healthcheck" - effectively rebutted Walensky's comments, after spokesman Jim McKinney told Just The News that the agency stands by its assessment of PCR tests.

According to McKinney, the "high sensitivity and specificity" is exactly why the tests remain the "gold standard."

The CDC's acknowledgment is not new, McKinney said, pointing to the agency's clarification of updated isolation guidance in August 2020, two weeks before the Times report on PCR tests.

While it said "people can continue to test positive for up to 3 months after diagnosis and not be infectious to others," the CDC said that "does not imply a person is immune to reinfection" within three months. (A review of global databases last month found reinfections of the naturally immune were "rare" and "generally mild.")

McKinney also noted the FDA told the Times that "commercial manufacturers and laboratories set their own" CT levels. -JTN

So the FDA knew all along that people have been missing work and avoiding life because they're testing positive long after they're infectious?

"Think of all the lives ruined, jobs lost, education squandered b/c of false positives," tweeted Justin Heart of Rational Ground. "We've been saying since summer 2020 that the PCR test can be positive at 5 days or 75 days. And ONLY JUST NOW is it being used to adjust policy."

I can't even express how angry this makes me. Think of all the lives ruined, jobs lost, education squandered b/c of false positives. We've been saying since summer 2020 that the PCR test can be positive at 5 days or 75 days. And ONLY JUST NOW is it being used to adjust policy. https://t.co/4Q6rHFDB4S

— Justin Hart (@justin_hart) December 29, 2021

https://www.zerohedge.com/covid-19/fda-maintains-pcr-tests-are-gold-standard-despite-cdc-dropping-over-positive-results-12

S.Africa lifts curfew as it says Covid omicron peak has passed

 South Africa lifted a midnight to 4 a.m. curfew on movement with immediate effect as it believes the country has passed the peak of its fourth Covid-19 wave driven by the Omicron variant, a cabinet statement said on Thursday.

South Africa, which is currently at the lowest of its five-stage Covid-19 alert levels, made the changes based on the trajectory of the pandemic, levels of vaccination in the country and available capacity in the health sector.

Besides lifting the restrictions on public movement, the government said gatherings will be restricted to no more than 1,000 people indoors, and no more than 2,000 people outdoors.

It also ruled that alcohol shops with licenses to operate beyond 11 p.m. (2100GMT) may revert back to full license conditions, a welcome boon for traders and business hard hit by the pandemic and looking to recover during the festive season.

“While the Omicron variant is highly transmissible, there has been lower rates of hospitalisation than in previous waves. This means that the country has a spare capacity for admission of patients even for routine health services,” the cabinet said.

https://www.cnbc.com/2021/12/30/south-africa-lifts-curfew-as-it-says-covid-fourth-wave-has-passed-the-peak.html

CES to Now End Sooner Than Planned as Omicron Cases Surge

 CES will now end a day earlier than planned, the organizer of the global technology and gadget show said, after companies including Amazon.com Inc and General Motors Co dropped out of attending the Las Vegas event in person due to Omicron concerns.

"The step was taken as an additional safety measure to the current health protocols that have been put in place for CES," the event organizer Consumer Technology Association (CTA) said on Friday, announcing the event will now end on Jan. 7.

The spread of the highly transmissible Omicron variant has led to a sharp jump in COVID-19 infections across the world, making many reconsider their travel plans and leading to thousands of flight cancellations.

The number of new COVID-19 cases in the U.S. has doubled in eight days to a record high of 329,000 a day on average, according to a Reuters tally.

As worries over the new variant loom, many companies have withdrawn from presenting in-person at the event, planned both virtually and in-person, that begins on Jan.5 with over 2,200 exhibitors.

Over the last few days, a host of firms including Advanced Micro Devices, Procter & Gamble, Alphabet Inc's Google, Facebook parent Meta Platforms have also dropped their in-person plans.

Sony Group's Sony Electronics has said it will have limited staffing and attendees at the event.

All attendees in Las Vegas will be required to be fully vaccinated and masked. COVID-19 test kits will also be provided at the venue, according to CTA's statement.

https://money.usnews.com/investing/news/articles/2021-12-31/ces-to-now-end-sooner-than-planned-on-omicron-concerns

How easy will health insurers make it to get free, at-home COVID-19 tests?

 Trying to get screened for COVID-19 before the holidays, Gia Ingenito stood in a long line at a free testing site in a park two blocks from the White House last week.

The free, at-home tests at her neighborhood library had been snapped up in minutes.

So she patiently waited in the December chill, on the day President Joe Biden announced new measures to make at-home tests more available—although not until January.

Next month, Americans will be able to request free tests from a website and kits will be mailed to homes.

The website, and other details about how and when the tests will be distributed, have not been released.

Also still to come are the parameters for how private health insurers will have to pick up the tab for over-the-counter tests, a requirement Biden announced at the beginning of December as the highly infectious omicron variant was just starting to spread.

If consumers have to seek reimbursement from the insurer after buying a test, rather than getting it free at the pharmacy, that would be "better than nothing," said Ingenito, 37, an executive assistant at an accounting firm.

"But it's another deterrent," she added.

Ingenito said it would be "ideal" if consumers could just show an insurance card when picking up an at-home test at the pharmacy, similar to how she provided her insurance information at the city's free site.

She's not alone in that view.

Experts urge fewer hurdles

It's not clear yet if the White House plan will require consumers to seek reimbursement from insurers, or if insurers will work with pharmacies to make the tests free to consumers up front.

Several top health experts have urged the latter approach. They say that requiring reimbursement would create additional hurdles for consumers, who would have to save receipts, submit them and wait to get their money back. And the U.S. can't afford a burdensome process at a time when infections are rising, the demand for testing is higher than ever, and people are gathering inside during the winter months.

"If you are somebody who is struggling to make ends meet and they're being asked to spend some of your own money to buy rapid tests and then wait for reimbursement, that's really not even going to be an option for people even if they do get reimbursed," said Dr. Celine Gounder, an epidemiologist who advised Biden's transition team on COVID-19.

But insurers might not want to make it too easy to get the free tests. Extensive use could escalate their costs and health plans have warned those bills could a be passed along to consumers through higher premiums.

Ensuring that Americans can get tested easily and affordably is a central part of the administration's strategy to reduce the spread of the coronavirus without shutting schools and businesses. But in addition to the cost obstacle, tests are in short supply. Retailers have been limiting how many can be purchased at a time.

"One of the other things that we know that has to be done is more testing," Biden said when announcing new measures to help. "And on that score, we are not where we should be."

Adrienne McCray, a 47-year-old landscape architect who put an hour's worth of money into her parking meter before getting in line for a COVID-19 test Tuesday, said she would use her health insurance to get an at-home test even if it meant having to seek reimbursement after purchase. But she thinks many others will bypass that option.

"It just needs to be more accessible all around," McCray said of testing.

Insurers can make it easier or harder

Jeff Zients, the White House COVID-19 response coordinator, said last week that all ideas, including requiring insurers to work with pharmacies so people don't have to file for reimbursement, are "on the table."

"That'll be worked through across the next couple of weeks with clear guidance on how American consumers with private health insurance can be easily reimbursed for their test," Zients said during the COVID team's final briefing before Christmas.

Without a mandate, insurance companies will decide how easy they want it to be for consumers to buy tests, said Larry Levitt, executive vice president for health policy at the Kaiser Family Foundation, a non-partisan research organization.

"My guess is they're going to make it hard, not easy, for people to get them," he said. "The cost could end up being substantial."

Insurers are already required to pay for COVID-19 tests administered at testing sites and medical offices, which can cost $100 or more. Home-tests, which consumers can buy without a prescription at retail stores or online, are less expensive. Walmart sells the BinaxNow kit for $14. Others cost $25 or more.

The cumulative cost would quickly mount if the more than 150 million people with private insurance want to test themselves weekly, or even more often, with at-home kits.

Despite what insurers are already spending on pandemic-related costs, however, Levitt said they have "still done quite well" financially.

Insurers already have options

Even before Biden's announcement, Express Scripts, one of the nation's largest pharmacy benefit managers, announced it's offering health plans the option of covering over-the-counter COVID-19 test kits through their existing pharmacy benefit plans.

If insurers go along, consumers could use their Express Scripts member ID card to pick up tests at participating in-network pharmacies starting in January.

Express Scripts didn't respond to questions about whether insurers have expressed interest in that option.

A spokesman for the trade association representing pharmacy benefit managers deferred questions about the Biden administration's reimbursement requirement to insurance companies.

Kristine Grow, spokeswoman for America's Health Insurance Plans, said it's too soon for her trade association to comment on "potential approaches until we receive further guidance from the administration."

When Biden's reimbursement requirement was announced in early December, Grow said that while ensuring everyone has access to affordable testing is an important tool to fighting the pandemic, the reimbursement requirement could also lead to manufacturers hiking the cost of the tests and higher insurance premiums.

"As we continue our work with the administration in the fight against COVID-19," Grow said at the time, "we will make sure that the full impact of these actions on patients, consumers, and hardworking families is understood."

The nation's pharmacies might also oppose any effort to nix the up-front consumer payment requirement. Drug stores are fine with selling the tests, but they're concerned that having to work out payments with insurers, instead of customers, will burden pharmacists who are already strapped by the pandemic.

"From the patient standpoint, absolutely, it would be easy and probably more accessible," said Hannah Fish, director of strategic initiatives for the National Community Pharmacists Association, said of having pharmacists get paid by health plans rather than consumers. "From a pharmacy standpoint, it would actually make it a little more challenging."

Testing services tend to be covered on the medical benefit side of health insurance rather than the prescription side, Fish said. And reimbursements on the medical side are not as straightforward—and are often delayed, she added.

Plus, not every pharmacy has a contract with all insurance plans, and tests don't have to be purchased in pharmacies; some will be purchased online or through other retailers.

Experts say the White House's testing plan should be driven by what will deliver the biggest public health benefit, not what hurdles it might create for insurers and pharmacies. Any obstacles for consumers will have a negative impact on their ultimate goal: Getting the pandemic under control.

"If consumers face out-of-pocket costs, even if they're relatively cheap, the likelihood is that they won't use the tests," said Rena Conti, associate professor at the Questrom School of Business.

She said decades of economic research shows that the default option matters. So if consumers have to seek reimbursement, inertia will set in and they won't do it.

Waiting for White House guidance

Sabrina Corlette, a co-director of the Center on Health Insurance Reforms at Georgetown University's McCourt School of Public Policy, said insurers might actually find it easier to deal with pharmacies and pharmacy benefit managers instead of consumers.

"There's not just the cost to the carrier in terms of cutting the checks," she said. "It's a hassle factor for them too, to be collecting all these receipts."

Still, she said, "so much depends on the guidance that the administration puts out next month."

Health and Human Services Secretary Xavier Becerra said there is always the possibility that insurers could challenge the reimbursement requirement, similar to how the administration's mandate that larger employers ensure their workers are either vaccinated or regularly tested is now before the Supreme Court.

"We've done what we think our authorities allow us to do. Now we've got to see it play out," Becerra told reporters this month. "So if an insurer says, 'I'm not paying for it,' we'll test that out."

Micah Johnson, who was waiting for a COVID-19 test last week to "take every precaution" before seeing his granddaughter, had spent 20 minutes on hold trying to find a testing site before lining up in the park.

Johnson, 73, welcomed more options but feels the government has been more reactive than proactive in dealing with the pandemic.

"It is what it is," Johnson concluded. "I'm just going to do my part—and try to take advantage of what is available."

https://medicalxpress.com/news/2021-12-easy-health-free-at-home-covid-.html