EU watchdog says supports fast development of Omicron-only vaccine

 The European Union's drug regulator said on Thursday it would support a filing for approval of an upgraded COVID-19 vaccine targeting only the new Omicron variant if that is the quickest way to broaden the offering of available shots.

Speaking to journalists in a briefing, the European Medicines Agency's (EMA) head of vaccines strategy, Marco Cavaleri, reiterated that he encouraged pharmaceuticals companies to explore not only a monovalent shot tailored to the Omicron variant but also versions that address a combination of variants.

Testing several vaccines in clinical trials would be "the most robust way forward", said Cavaleri.

"But at the same time if an Omicron monovalent vaccine can be put into clinical trials rapidly. I think we can only support that."

Pfizer and partner BioNTech last month started a clinical trial to test a new version of their vaccine specifically designed for Omicron, which has eluded some of the protection provided by the original two-dose vaccine regimen.

In the briefing, Cavaleri added that it was uncertain whether vaccine candidates from French biotech firm Valneva and by a partnership of Sanofi and GlaxoSmithKline could win approval by Easter, or mid-April.

"We need really to look into the results of such clinical trials and to make an assessment, including having a good understanding of whether the data will be covering the entirety of the adult population or if they will be restricted," he said.

The vaccines, if they pass muster, would broaden the availability of shots based on more conventional medical technology such as Novavax's Nuvaxovid, which won EU clearance in December.

The widely used Pfizer/BioNTech and Moderna shot are based on novel mRNA technology.

https://www.marketscreener.com/quote/stock/GLAXOSMITHKLINE-PLC-9590199/news/EU-watchdog-says-supports-fast-development-of-Omicron-only-vaccine-37735017/

Medicare to pay for at-home COVID-19 tests this spring

 Medicare will soon start to pay for at-home COVID-19 tests, allowing beneficiaries to have the same access to free over-the-counter tests as people with private insurance.

The Centers for Medicare and Medicaid Services on Thursday announced a new initiative that will allow Medicare beneficiaries and people with Medicare Advantage plans to access up to eight over-the-counter COVID-19 tests per month for free at participating pharmacies and retailers, beginning "in the early spring."

Medicare will directly reimburse participating pharmacies and other retailers, allowing Medicare beneficiaries to pick up tests at no cost. 

"There are a number of issues that have made it difficult to cover and pay for over-the-counter COVID-19 tests. However, given the importance of expanding access to testing, CMS has identified a pathway that will expand access to free over-the-counter testing for Medicare beneficiaries," the agency said in a statement.

The White House last month began requiring private insurance companies to cover the cost of eight at-home COVID-19 tests per person each month, if the customer files for reimbursement. The requirement was put in place as a result of the massive surge in infections due to the omicron variant.

But the policy did not apply to Medicare beneficiaries, and the exclusion of millions of older and disabled Americans triggered a backlash. Administration officials recognized the problem and have been working to find the best way forward. 

The problem was that traditional Medicare only pays for COVID-19 diagnostic tests performed by a laboratory, such as PCR and antigen tests. If the test is ordered by a physician, pharmacist or "authorized health care professional," there's no cost to the beneficiary. 

Some people enrolled in Medicare Advantage, where beneficiaries join private managed care plans, might have been eligible for reimbursement, but each company sets its own rules so coverage varies.

https://thehill.com/policy/healthcare/592635-medicare-to-pay-for-at-home-covid-19-tests-this-spring

Makary Slams Media, Hopkins For Hiding Bombshell Study That Found Lockdowns Ineffective

 by Steve Watson via Summit News,

A Johns Hopkins professor slammed his own university and the establishment media for failing to report on a major study that concluded lockdowns have been almost completely ineffective at curbing COVID mortality rates.

As we reported yesterday, the study was authored by multiple eminent researchers at the University and concluded that  lockdowns “are ill-founded and should be rejected as a pandemic policy instrument.”

The authors wrote that “While this meta-analysis concludes that lockdowns have had little to no public health effects, they have imposed enormous economic and social costs where they have been adopted.”

Appearing on Tucker Carlson’s show Wednesday, Johns Hopkins professor of surgery Dr. Martin Makary blasted the college, noting “Johns Hopkins itself did not even put out a press release about this study, and if you look at the media coverage, it’s one of the biggest stories in the world today, and yet certain media outlets have not even covered it.”

Makary urged that the reason for hiding the study is that “people may already have their own narrative written” about the effectiveness of lockdowns.

The professor dug down into the study and noted that it found that the number of lives saved by the lockdowns is infinitesimal compared to those lost through missed cancer diagnosis and treatment alone.

“It was 124,000 excess deaths in year one. So, over two years, it was about a quarter million people who died,” Makary noted.

He added, “I think the public is hungry for honesty and basic humility from public health officials.”

Watch:

Makary also appeared on Fox Business to discuss the study:

Senator Rand Paul also referred to the new Johns Hopkins study in an appearance Wednesday, noting “I hope we’ll learn from this the study. There was no correlation between any of the mandates the government put in place and any change in the incidence of the disease.”

Paul reminded viewers that Anthony Fauci has repeatedly claimed that lockdowns have saved millions of lives.  

“It’s become so politicized that I don’t think Dr. Fauci will ever apologize or admit to the country, but we need to have people like him removed from office because they’ve been so wrong on so much policy,” Paul urged.

Watch:

Other Republicans commented on the Johns Hopkins study Wednesday.

Sen. Roger Marshall, R-Kansas told reporters “Bad judgment and poor leadership from our nation’s health agencies have caused most Americans to live with an unhealthy fear of COVID-19. There is no doubt, we need a new approach to COVID as we must learn to live with it.”

Marshall echoed Paul, stating “That new approach should not include Dr. Fauci – American’s don’t trust him and he has lost his reputation. We must stop the obsession with COVID, stop living in fear and move forward.”

The latest developments come on the heels of 70 per cent of Americans asserting that it’s time to live with COVID and get on with our lives.

https://www.zerohedge.com/covid-19/watch-johns-hopkins-prof-slams-media-own-institution-hiding-bombshell-study-found

Hospitals’ cash prices for services offer a new look at health care pricing

 There are several common narratives about variations in health care prices: Uninsured consumers are dunned for full chargemaster prices, consumer advocates complain. Insurers with outsized market power drive down physician reimbursement, say the medical societies. Providers offer the best prices to payers with larger market shares who bring a high patient volume, doctors say.

Recent research exploiting hospital price disclosures has debunked these canards. As some health policy analysts already suspected, hospital prices available to individuals willing to pay cash can be lower than those negotiated by insurers. To summarize findings from data I collected for select medical services amenable to shopping, the cash prices reported by hospitals is lower than the highest insurer-negotiated price 87% of the time; lower than most major insurers’ negotiated prices 55% of the time; and lower than even the lowest insurer-negotiated price 43% of the time. Indeed, the payer with the highest market share sometime pays more than smaller insurers.

Findings published recently from an analysis of a more comprehensive dataset were not quite as dramatic, but were generally in accord with mine.

About one-quarter of workers’ overall earnings are diverted to health insurance plans that are supposed to be negotiating low prices on their behalf. If, in fact, workers could get better prices without their insurers’ help, then money that ought to be in paychecks is going to hospitals. How should stakeholders and policymakers react to these findings?

Unpacking cash prices

Hospital price transparency regulation defines discounted cash price as the amount “that applies to an individual who pays cash (or cash equivalent) for a hospital item or service.” In my experience as an attorney representing uninsured clients, such cash prices can result from settling a collection lawsuit by a hospital or settling a personal injury claim on which a hospital has a lien.

But there are some niche retail markets for hospital services, as when:

• Amish and old order Mennonite patients who spurn insurance seek care;
• Surgical centers cater to self-pay patients;
• Consumers shop for services that cost less than the deductible in their high-deductible health plans;
• Payers such as health sharing ministries individually negotiate prices on particular patients’ behalf.

In a recent review of hospitals’ disclosed prices, nearly 1,000 hospitals listed cash prices. That comes as a surprise, and qualitative research will be needed to better flesh out what happens in this hidden marketplace.

What dynamics are at work?

Two hypotheses attempt to explain why cash prices can be lower.

The imperfect agent hypothesis holds that insurers and third-party administrators fail to zealously represent employer and consumer interests because — in its most simple formulation — they’re “negotiating with somebody else’s money.” A more cynical formulation holds that payers want health care to be expensive because “if medical services were cheap, we wouldn’t need … insurers to bear the cost for us.” Evidence supporting the imperfect agent hypothesis emerges each time an employer takes price negotiations into its own hands, or a group of employers does so, and secures a better deal.

The deep pocket hypothesis recognizes that an insurance pool has a greater ability to write large checks than an individual does, and can almost invisibly collect money directly from workers’ earnings. As such, providers expect a larger payment from insurers and employers, and payers conform to this expectation. The deep pocket concept comes from tort law, where it signifies a bias on the part of jurors to award more damages to plaintiffs they know are insured. It’s considered a bias because the cost of making an injured person whole is the same regardless of whether the defendant has insurance.

Overly generous prices result from an interplay of both factors. The bottom line is that hospital prices are higher than they should —and probably could — be. Emerging insights into pricing dynamics suggest an agenda for change.

Implications for stakeholders and policymakers

A cash transaction by an individual represents his or her decision-making in the face of finite resources and trade-offs against foregone expenditures on other necessities or luxuries. An insurer doesn’t consider whether a family is better off paying for a joint replacement for Mom or for a more reliable car. As such, the cash price of a procedure may be a purer estimate of its value than prices negotiated by insurers. To the extent that the cash price is lower, achieving that level of pricing should be a goal for payers and policymakers.

Here are some actions to consider:

Reference pricing is a cost-cutting technique that may be advanced by disclosing cash prices. With reference pricing, a health plan reimburses providers for a service at a fixed amount. The employer can’t always be sure whether a provider will accept that amount in full, setting up a potential impasse. But an employer that sends most of its workers to a hospital with lower cash prices could peg reimbursement to those prices. While it is by no means certain that the hospital would or must accept that price, its disclosure gives an employer significant new leverage to use this technique.

Compensation of insurers and third-party administrators needs to be restructured to align their incentives with lower negotiated prices. These entities should not be rewarded for negotiating a price higher than the one available to individuals. I have argued elsewhere that insurance regulators should use their rate-approval authority to pressure insurers to obtain better prices. Employers may want to tie the fees they pay to third-party administrators to their success in getting plan prices closer to cash prices.

Greater scrutiny of pharmacy benefit managers by payers is warranted by the hospital cash price phenomenon. Cash prices for pharmaceuticals in a given locale can be easily obtained from GoodRx and others while prices negotiated by pharmacy benefit managers remain obscured — at least for now. But payers that have had their pharmacy benefit managers audited should immediately check to see if any prices divulged are higher or lower than reported pharmacy cash prices.

All-payer rate setting by state authorities is controversial as a severe intrusion into markets. Such regimes mandate the prices hospitals charge to all patients. A potential middle-ground approach would be to cap the amounts insurers pay to hospitals — a sort of mandatory reference pricing. With this option, the rate-setting authority attempts to set payment for a service at an amount that negates any deep-pocket distortions while sufficing to cover the costs of an efficient provider. Financially vulnerable patients could be protected from lawsuits for a remaining balance through exemptions from debt collection, but providers would still have the option of charging a full price to those with the ability to pay it.

I never bought into the Trump administration’s rationale for price transparency — that it would empower consumers to negotiate prices — but I assumed that the disclosures would draw scrutiny toward insurers’ price negotiations. What I and others have learned from hospital price disclosures is that the process is even more flawed than we’d imagined, and badly in need of reforms.

Jackson Williams is vice president for public policy at Dialysis Patient Citizens. He previously worked on health care quality and payment reform issues at the Centers for Medicare & Medicaid Services.

https://www.statnews.com/2022/02/03/hospitals-cash-prices-for-services-offer-a-new-look-at-health-care-pricing/

SOC Telemed to be Acquired by Patient Square Capital

 SOC Telemed stockholders to receive $3.00 per share in cash

- Partnership enables continued growth and expansion of leading US provider of acute care telemedicine

https://finance.yahoo.com/news/soc-telemed-acquired-patient-square-120000122.html

FDA nominee meets unexpected hurdles

 Biden's pick to lead the Food and Drug Administration (FDA) is facing surprising headwinds, as Senate Democrats work to build up enough bipartisan support for confirmation.

More than two months after being nominated, it’s unclear if Robert Califf has enough votes to be confirmed. At least five Democrats have already spoken out against him, and others remain undecided.

At the same time, Republicans are facing pressure from anti-abortion groups, which have mobilized against Califf. He gained just four GOP votes in a committee vote last month.

Califf, a cardiologist and Duke University researcher, was confirmed to the same post by a vote of 89-4 in 2016 when he was nominated by former President Obama, so the opposition this time is unexpected.

Some Democrats said they are still confident Califf will get 50 votes, but there are concerns about extra drama during a process that was supposed to be fairly smooth.

“I think he’ll have the votes. But it’s going to be an interesting mix of Republicans and Democrats,” said Sen. Chris Murphy (D-Conn.).

Sen. Dick Durbin (Ill.), the No. 2 Senate Democrat, said the votes were “very close.”

The FDA is one of the primary agencies helping shape the nation’s response to the global COVID-19 pandemic that has killed more than 880,000 Americans. It regulates products like masks, lab tests and vaccines, but is also responsible for the nation’s food supply.

The agency is being run in an acting capacity by Janet Woodcock, a career FDA official who previously was in charge of the agency’s drug evaluation unit. Woodcock’s tenure was limited by federal law, and Biden waited until almost the last minute to name a nominee.

The White House for months deflected questions about the delay in nominating a Senate-confirmed FDA commissioner, saying it wanted to be sure whoever they chose could get majority support in the chamber.

Officials have said they still believe Califf can earn bipartisan support to offset the Democratic defectors, pointing to his last confirmation hearing and his broad experience as a doctor and researcher.

Four Democrats — Sens. Joe Manchin (W.Va.), Ed Markey (Mass.), Maggie Hassan (N.H.) and Richard Blumenthal (Conn.) — as well as Sen. Bernie Sanders (I-Vt.) have signaled opposition to Califf’s nomination over his ties to industry and the FDA’s role in the opioid crisis.

Since he left government, Califf has advised Google Health and its spinoff, Verily Life Sciences, where he was paid millions in stock and more than $2.7 million in salary and bonuses.

Sen. Ron Wyden (D-Ore.) told reporters Tuesday that he had a “productive” call with Califf on Monday, but has not made a decision yet and has more follow-up questions. Wyden noted White House staff were on the call as well, and said he asked Califf about “how he would, at FDA, hold the big pharmaceutical companies accountable.”

On the Republican side, anti-abortion groups have been lobbying hard against Califf. The Susan B. Anthony List said it would “key vote” Califf’s nomination as a result of his work on the abortion drug mifepristone during the Obama administration.

Nearly all Republican senators have an A+ from the organization, with the exceptions of Sens. Susan Collins (Maine) and Lisa Murkowski (Alaska). Collins and Murkowski joined with Sens. Mitt Romney (Utah) and Richard Burr (N.C.) as the only Republicans to vote for Califf in committee.

Burr, who is the top Republican on the Senate Health Committee, said he knows his colleagues are feeling pressure from anti-abortion groups worried about increased access to mifepristone.

“I like him,” Burr said of Califf. “I think he’ll be confirmed. The overall concern is from the pro-life community, which Dr. Califf wasn’t there when this decision was made, so I’m not sure why they’re so irate.”

Senior White House officials are making bipartisan calls to senators asking for support.

A White House official said Califf has met with 33 senators so far, and is scheduled to meet with at least 14 more. Of those meetings, 26 are with Democrats and 21 with Republicans.

“We are working hard and HHS is working hard every day to get Dr. Califf nominated. We believe it is extremely important to have a confirmed head of the FDA in the midst of the pandemic,” the White House said.

Marc Scheineson, a partner at Alston & Bird who served as associate commissioner for legislative affairs under former FDA Commissioner David Kessler, said he thinks the administration underestimated the difficulty of Califf’s nomination.

“I think they’re surprised. I think they have a lot more work to do. And they really didn’t want to invest their limited resources in something that they thought was pretty easy,” Scheineson said. “I think they thought this was a bit of a slam dunk ... I think that’s why they selected [Califf].”

https://thehill.com/policy/healthcare/592591-fda-nominee-meets-unexpected-hurdles

BioCardia Gets Breakthrough Device Designation for CardiAMP Cell Therapy System for Heart Failure

 BioCardia®, Inc. (Nasdaq: BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the CardiAMP® Cell Therapy System for the treatment of heart failure. It is believed to be the first cardiac cell therapy to receive FDA Breakthrough Device status.

CardiAMP Cell Therapy uses a patient’s own (autologous) bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure. The therapy incorporates a pre-procedural screening assay to identify patients who may be likely responders, a first for a cardiac cell therapy and designed to enhance patient selection. Eligible patients receive a high dose of cells using an intramyocardial delivery system that has been shown in published literature to present the lowest risk to patients for biotherapeutic delivery1 and to be three to six times more efficient at delivering cells to the heart muscle than other methods.2 This approach allows the patient to be discharged from the hospital the morning after the procedure.

CardiAMP Cell Therapy is designed to potentially stimulate the body’s natural healing response, provoking a beneficial paracrine reaction to repair the heart. This is a different mechanism of action from other therapies that have sought to transform stem cells into new heart cells, a method that has presented patient risks, such as rhythm abnormalities and cell rejection.

https://finance.yahoo.com/news/biocardia-receives-fda-breakthrough-device-130000904.html