Hospitals want CMS to review UnitedHealth changes for lab tests, specialty drugs

 The American Hospital Association urged CMS to review new policy changes from UnitedHealthcare that concern diagnostic and specialty pharmacy services that the insurer says are needed to lower medical costs.

In a Feb. 4 letter to acting CMS Administrator Elizabeth Richter, the AHA argued two new UnitedHealthcare policies "create significant barriers to access to necessary diagnostic and specialty pharmacy services for tens of millions of health plan enrollees." 

One policy is UnitedHealthcare's designated diagnostic provider program. Beginning July 1, diagnostic tests completed at a facility that isn't a "designated diagnostic provider" won't be covered for UnitedHealthcare's commercial health plan members. Labs that are designated diagnostic providers will be reimbursed at a fixed rate. 

Under the policy, coverage will be denied for patients who receive testing at a non-designated laboratory even if the provider is considered "in-network." UnitedHealthcare is providing members a one-time exemption if they use a non-designated lab, but otherwise, members will need to pay out of pocket for testing that is completed at a non-designated lab. The requirement doesn't include inpatient or emergency room tests.

The AHA said this setup could result in surprise medical bills for patients, adding that the policy attempts to "redefine the concept of an 'in-network' provider and limit patient access to a much smaller pool of laboratory service providers."

UnitedHealthcare is updating its provider directories to show the change and is contacting members who have used a non-designated diagnostic provider in the past to help them better understand the new policy, a spokesperson from the insurer said. The change aims to address discrepancies in how much certain diagnostic tests cost in a hospital outpatient setting versus a freestanding laboratory, according to UnitedHealthcare.

"UnitedHealthcare members may pay as much as 500 percent more on average for lab services, depending on where they are performed. Designated Diagnostic Provider benefit designs will cover outpatient lab services provided by qualified free-standing and outpatient hospital laboratories who meet quality and efficiency criteria," the insurer said in a statement.

Providers have until Feb. 28 to meet certain quality and efficiency metrics to become a designated diagnostic provider. Some criteria include getting accreditation from organizations like the American Association for Laboratory Accreditation, the College of American Pathologists and the Joint Commission. Providers who meet the criteria after the deadline will continue to be reviewed for designated diagnostic provider status. Facilities that don't meet the requirement will still maintain their network status, which is where AHA says the confusion lies.

"Because the enrollees' plan materials still will identify these non-designated labs as 'in-network' providers, this policy will create significant confusion for those seeking care," the AHA said.

Members who are not aware of the change and face a bill can file an appeal with UnitedHealthcare, the insurer said.

The other policy AHA mentioned in its letter concerns specialty pharmacy coverage. The AHA said UnitedHealth is "driving a significant change in the drug supply chain through its OptumRx subsidiary." New specialty pharmacy policies in plans are increasingly requiring providers to accept drugs purchased and handled by OptumRx, according to the AHA.

In a statement about the changes, UnitedHealthcare said: "As of Oct. 1, 2020, outpatient hospital providers in UnitedHealthcare's commercial network are required to source certain specialty drugs from indicated specialty pharmacies, unless otherwise authorized by UnitedHealthcare. This approach allows UnitedHealthcare to potentially eliminate unnecessary costs from the healthcare system to help make healthcare more affordable."

The two policies "warrant immediate attention by [CMS] in its oversight of health plans serving enrollees in Medicare Advantage, Medicaid managed care, Children's Health Insurance Program and Health Insurance Marketplace health plans," the AHA said.

https://www.beckershospitalreview.com/payer-issues/new-unitedhealthcare-policies-change-coverage-for-lab-tests-specialty-drugs-hospitals-want-cms-to-review-them.html

Feb. 26 AdComm to discuss J&J COVID-19 vaccine EUA

 Johnson & Johnson has filed for emergency FDA authorization of its one-dose COVID-19 vaccine. The FDA has scheduled an advisory committee meeting to discuss the application for Feb. 26.

One week ago, J&J presented data showing its viral vector vaccine was 66% effective at preventing moderate to severe COVID-19 in a phase 3 clinical trial. The efficacy, while below that achieved by vaccines from BioNTech-Pfizer, Moderna and Novavax, marked a step toward the sale of a vaccine that could deliver a big boost to the global vaccination effort given its stability at fridge temperature, one-dose regimen and J&J’s manufacturing muscle. 

J&J has moved quickly to get the vaccine to market, filing for emergency use authorization less than one week after sharing the top-line data. The Big Pharma plans to keep up the pace after securing an EUA. J&J expects to have doses ready to ship as soon as the FDA makes a decision and to go on to sell 100 million doses in the U.S. by the midpoint of the year.

With the FDA scheduling a meeting of outside experts to review the data for Feb. 26, J&J may be able to start shipping doses by the end of the month. In December, the FDA granted an EUA to Moderna’s vaccine one day after it received the support of the advisory committee. 

Authorization of the vaccine would boost the U.S. vaccination program, which has been blighted by shortages. With J&J’s vaccine only needing one dose, it alone will equip the U.S. to vaccinate more than one-third of all adults by around the middle of the year if it hits its target of 100 million vials. With Pfizer aiming to supply 200 million doses, enough to vaccinate 100 million people, by the end of May and Moderna also making shipments, the U.S. could soon have the vials to vaccinate all adults. 

The success of the mass-vaccination campaign will depend on the evolution of the virus and the efficacy of the prophylactics against whatever variants are circulating in the U.S. J&J saw efficacy fall away somewhat in South Africa, where a troublesome variant is predominant, but not to the extent that the protection provided by Novavax’s vaccine declined in the country. 

https://www.fiercebiotech.com/biotech/fda-arranges-feb-26-adcomm-to-discuss-j-j-covid-19-vaccine-eua

Orthopedic therapy developer Bioventus returns with 2nd IPO, totaling $125M

 The orthopedic therapy developer Bioventus is hoping second time’s the charm, with a new attempt at going public after withdrawing its last IPO filing over four years ago.

The former spinout of Smith & Nephew—with medtech and biologic products focused on healing broken bones and relieving joint pain—will offer 7.35 million shares at between $16 and $18 a piece, for a total of about $125 million. 

The company plans to list on the Nasdaq with the ticker BVS and would maintain a market value of $922 million if shares price at the midpoint of the proposed range, according to Renaissance Capital.

Bioventus’ products are divided into three verticals: injection regimens for joint preservation and pain treatment; bone graft materials, including human tissue allografts and synthetics, as well as marrow isolation systems; and a minimally invasive ultrasound device designed to stimulate healing in long bone fractures.

The Durham, North Carolina-based company is also developing a placental tissue biologic for osteoarthritis of the knee and inked an agreement with CartiHeal for access to an off-the-shelf scaffold implant for osteochondral defects of the knee joint. Bioventus is also collaborating with Harbor to commercialize a rotator cuff tissue repair product, slated for FDA review in mid-2022.

Net sales for 2019 totaled $319.2 million, though revenues declined in 2020 due to the COVID-19 pandemic, with the first nine months amounting to $222.6 million compared to $242.6 million in the same period the year before.

Bioventus previously pitched a $150 million IPO in the summer of 2016, with plans to pay off at least $60 million of its debt, but ended up postponing the offering later that August.

Now, the company said in its new prospectus that it plans to use a portion of the proceeds to settle the severance package for its former CEO, Tony Bihl—who retired in April 2020, after the company appointed Ken Reali, previously president and CEO of Clinical Innovations, as its new chief.

The package includes a cash payment of $1.54 million, plus either $7.71 million or more depending on the market value of management incentive awards and his ownership in the company, due this coming June.

https://www.fiercebiotech.com/medtech/orthopedic-therapy-developer-bioventus-returns-second-ipo-totaling-125m

Moderna sets sights on $200M vaccine factory in Seoul

 With supply contracts for 50 million COVID-19 vaccine doses in Japan and 40 million in South Korea, Moderna has already made a push into the Asian market. Now, it's laying out plans for a factory all its own in the region.

The Cambridge, Massachusetts-based drugmaker is in talks with the South Korean government to invest $200 million into a vaccine production plant in the country, Park Young-sun, a former government minister involved in the plans, told the Asia Business Daily, Reuters reports. Moderna is eager to push into the region, she added. 

It's unclear when the facility might come online, or how many doses it could add to Moderna's production output, though the South Korean capital of Seoul has been pegged as the facility's likely home, Reuters said.  Moderna was not immediately available for comment. 

Even as Moderna's COVID-19 shot rolls out in countries around the world, the company has continued to bolster its supply chain. The company in late December tapped Sweden's Recipharm for formulation and fill-finish work at its facility in Monts, France. Elsewhere in Europe, the company has teamed up with Spain's Laboratorios Farmacéuticos Rovi for fill-finish work on "hundreds of millions" of doses of Moderna's mRNA-based vaccines. 

Meanwhile, the company's first pandemic manufacturing partner, Lonza, is cranking out doses of the company's vaccine at both U.S. and Swiss facilities, while Catalent agreed to tackle finishing duties for at least 100 million doses at its Bloomington, Indiana plant. 

In Asia, where the company has pledged 50 million doses to Japan and another 40 million to South Korea, Moderna has already found Japanese manufacturing support by way of its 50-million-dose production deal with Takeda. 

Under that deal, Takeda is set to start importing and distributing Moderna's shot in the first half of 2021. It will also take the reins on local regulatory approvals, Takeda said. 

South Korea, meanwhile, clinched a deal for at least 40 million Moderna doses in late December. Deliveries should start arriving in the country in the second quarter, Moderna said at the time.

https://www.fiercepharma.com/manufacturing/moderna-sets-sights-200m-vaccine-factory-seoul-report

Made-In-Canada vaccine CEO pleads for federal government to respond

 A Canadian company currently conducting human trials for their COVID-19 vaccine is asking the federal government to respond to their request for support in producing the vaccine.

Speaking at a conference in Calgary on Friday, Brad Sorenson, CEO of Providence Therapeutics criticized the federal government for not responding to their proposal, which was sent a week ago.

"The apathetic response of the Government of Canada to a serious proposal that could save lives is unacceptable," Sorenson said, "Review it and reject it if there is no merit, embrace it if it's viable, but do something."

In the proposal, Providence Therapeutics asked for a $150 million investment which would act as a down payment on 50 million vaccine doses for Canadians.

"We committed to distribute those 50 million vaccines at 30 per cent less than international market rates for comparable mRNA vaccines," Sorenson said.

Manufacturing the vaccine costs more than the $150 million requested, and Sorenson said shareholders are ready to provide capital to ensure enough vaccine doses are available for Canadians.

Delivery on these doses could start as soon as September.

The vaccine is a messenger RNA (mRNA) vaccine which, pending positive results, may be available for immunization starting later this year or early 2022.

Like other mRNA vaccines, it takes two doses for complete vaccination and can be stored at -20 degrees Celsius.

 Manufacturing of the vaccine will take place at a Calgary facility, Northern RNA, the site of Friday’s announcement.

The proposal also outlined the importance of having domestic security of COVID-19 vaccine supply and laid out a plan that would see the entire manufacturing cycle be sourced in Canada by 2022.

Due to constraints and capacity issues at Northern RNA, certain aspects of final manufacturing has to be done in North Dakota.

Providence Therapeutics started human trials on Jan. 26 with 60 volunteers between the ages of 18 and 65 partaking.

Volunteers are split into three groups with each group receiving different dose levels. Placebo doses will be administered within each group.

Researchers believe they will receive enough data by April to be able to move into phase two starting in May pending approval of the vaccine.

Several pre-clinical animal trials were previously completed which evaluated the safety and efficacy of the vaccine prior to human trials.

A proposal is prepared to be sent to Health Canada for phase 3 of the trials which would include two thousand volunteers with no placebo shots given.

"Whether it's federal or provincial, I know we're going to get engagement"

Sorenson said he doesn't want to politicize the issue, but is disappointed in the lack of federal response.

"I don't have a choice, I have to do what I'm doing," he said. "If the federal government wants to pull it together and work with us, we're ready. We're ready, willing, and able."

Human trials of the first made-in-Canada vaccine has received interest from health care workers and premiers, with Providence Therapeutics meeting with some provincial leaders Friday afternoon.

"In the end, the people that I wanted to hear the message the most, the people I addressed that letter to last Friday refused to respond," Sorenson said.

Providence Therapeutics has partnered with the University of Toronto, the Ontario Institute of Cancer research, and Sunnybrook Research Institute, yet the vast majority of vaccine manufacturing has been completed without government support.

Made-in-Canada vaccine

During the conference, Sorenson asked Canadians to show initiative and demand that our leaders do so as well.

"We're not going to stop communicating with you, Canadians, as to where we're at and what we're doing. It's too important, that is my commitment to you."

Providence Therapeutics' vaccine was completely developed by Canadians, which Sorenson honored for their initiative during the press conference.

"What these 18 Canadians have accomplished under intense pressure needs to be recognized."

The vaccine was developed in under four weeks, complete with licenses to secure necessary intellectual property that was needed to advance their vaccine program.

All of which was accomplished while complying with COVID-19 regulations which reduced the number of employees that could be working at one time.

Sorenson said the made-in-Canada vaccine will help Canadians get immunized and help aid the global need for vaccines.

"We can stop trying to pay to jump the queue and we can contribute to the solution."

Personal sacrifice

In 2015, Sorenson's son was diagnosed with Stage 4 brain cancer the day after his thirteenth birthday.

Providence Therapeutics was created shortly after with a focus on creating a vaccine for cancer using mRNA.

2020 was supposed to be the year they entered clinical trials.

When the pandemic started, focus shifted to creating a COVID-19 vaccine.

"We put that cancer program on hold, a program that my son might need one day. Why? Because we had access to cutting-edge technology that could and is playing a major role in stopping the pandemic."

Pausing the cancer vaccine program was a difficult decision, but Sorenson says it was his moral obligation and his team took the initiative and got to work.

"Initiative improves outcomes and COVID-19 is like a cancer on our society," he said. "It is in our country, it is invisible, it is spreading, it is mutating, we cannot ignore it. If we do, people will die."

Sorenson hopes that with federal collaboration, Providence Therapeutics can help Canada defeat te COVID-19 pandemic.

"We're giving up the most important thing we have in this world—our time and our lives."

Providence Therapeutics' proposal to the federal government is available on their website.

https://calgary.ctvnews.ca/do-something-made-in-canada-vaccine-ceo-pleads-for-federal-government-to-respond-1.5297640

What’s the risk of dying from a fast-spreading COVID-19 variant?

 The news is sobering, but complicated. Scientists have released the data behind a British government warning last week that the fast-spreading SARS-CoV-2 variant B.1.1.7 increases the risk of dying from COVID-19 compared with previous variants. But some scientists caution that the latest study — like the government warning — is preliminary and still does not indicate whether the variant is more deadly or is just spreading faster and so reaching greater numbers of vulnerable people.

The latest findings are concerning, but to draw conclusions, “more work needs to be done”, says Muge Cevik, a public-health researcher at the University of St Andrews, who is based in Edinburgh, UK.

Last week, British Prime Minister Boris Johnson said preliminary data from several research groups suggested that B.1.1.7, which was first identified in the United Kingdom, was spreading more quickly than previous variants and was also associated with a higher risk of death. On 3 February, researchers at the London School of Hygiene & Tropical Medicine (LSHTM) released an analysis1 of some of those data, which suggests that the risk of dying is around 35% higher for people who are confirmed to be infected with the new variant.

In real terms, that means that for men aged 70–84, the number who are likely to die from COVID-19 increases from roughly 5% for those who test positive for the older variant, to more than 6% for those confirmed to be infected with B.1.1.7, according to the analysis. For men aged 85 or over, the risk of dying increases from about 17% to nearly 22% for those confirmed to be infected with the new variant. The analysis has not been peer reviewed.

Other groups are also studying whether B.1.1.7 and other new SARS-CoV-2 variants are more deadly than earlier versions of the virus.

Dominant variant

Since B.1.1.7 was first identified in September in southern England, it has become the dominant variant in the United Kingdom and has spread to more than 30 countries. To investigate whether the lineage causes an increased risk of dying, Nicholas Davies, an epidemiologist at the LSHTM, and colleagues analysed data from more than 850,000 people who were tested for SARS-CoV-2 between 1 November and 11 January but who were not in hospital.

Despite the fact that the B.1.1.7 variant was new, the researchers were able to identify people infected with it because of a glitch in a standard diagnostic kit used in the United Kingdom. The test normally looks for three SARS-CoV-2 genes to confirm the presence of the virus. But, in the case of B.1.1.7, changes to the spike protein mean that people who are infected still test positive, but for only two of these genes.

The team found that B.1.1.7 is more deadly than previous variants for all age groups, genders and ethnicities. “This provides strong evidence that there indeed exists increased mortality from the new strain,” says Henrik Salje, an infectious-disease epidemiologist at the University of Cambridge, UK.

However, Cevik says that the small number of deaths among young people included in the analysis is not enough to conclude that the new variant hits all ages equally. “It seems to really be affecting older age-groups,” she says.

This is to be expected, given that the chances of dying from COVID-19 increase significantly with age, says Tony Blakely, an epidemiologist at the University of Melbourne, Australia.

The findings are also consistent with other preliminary work summarized in a document published on 22 January by the New and Emerging Respiratory Virus Threats Advisory Group (known as NERVTAG), a government advisory group. One research team at Imperial College London found that the average case fatality rate — the proportion of people with confirmed COVID-19 who will die as a result — was some 36% higher for people infected with B.1.1.7.

Other explanations

Cevik says more data and analysis are needed to conclude whether the variant is more deadly than other lineages. For instance, the latest study doesn’t consider whether people infected with the variant have underlying comorbidities, such as diabetes and obesity, and are therefore more vulnerable and at higher risk of dying, she says.

The study also covers only a small fraction of COVID-19 deaths in the United Kingdom — some 7% — and the effect could disappear if deaths in people tested at hospitals are included, says Cevik. Preliminary work by other groups has not found an increased risk of death in people admitted to hospitals with the new variant, and this complicates the latest results.

Davies says it is possible that the new variant could be causing more severe disease, resulting in more people ending up in hospital, but that once there, their risk of dying could be the same as before. But he agrees that more data are needed before researchers can understand what’s going on.

Some researchers had also suggested that B.1.1.7 could contribute to an increase in deaths because of its fast spread, which would overwhelm hospitals and affect the quality of care. But Davies says that he and his team ruled that out because they compared the risks of death associated with the new and older variants for people who were tested at the same time and place, and so would be subject to the same conditions in hospitals.

doi: https://doi.org/10.1038/d41586-021-00299-2

https://www.nature.com/articles/d41586-021-00299-2

States are taking back unused Covid vaccine doses from nursing homes

 Dozens of states and cities are clawing back thousands of extra doses of Covid-19 vaccine that were meant to be used by CVS and Walgreens to immunize residents of nursing homes through a federal partnership set up by the Trump administration.

The partnership, called the Pharmacy Partnership for Long-Term Care Program, allowed states to tap CVS, Walgreens and other retail pharmacies to vaccinate residents and workers of nursing homes. The federal government asked states to “allocate ample vaccine supply” to the program if they opted in, according to Kristen Nordlund, a spokeswoman for the Centers for Disease Control and Prevention.

But now the program’s been left with “surplus vaccine supply” that at least 32 states and cities are taking back from the program and using for the general public, Nordlund said. She added that a combination of vaccine hesitancy, over-estimation of the number of doses needed for the campaign and other factors led to an oversupply of shots.

“Now that pharmacies have made substantial progress in efforts to vaccinate the long-term care facility population — and we have more insight on uptake in facilities enrolled in the program — we are working with jurisdictions to ensure they are able to easily use any excess vaccine for other targeted populations,” Nordlund said in a statement to CNBC.

The federal partnership program has caused headaches among some state health officers. While the pace has picked up in recent weeks, the partnership got off to a slow start in December. The states had to allocate doses for the program early on in the rollout, so the slow pace has created frustration and the appearance that states are failing to administer the shots they have.

Through the partnership, more than 4.2 million doses of vaccine have been administered as of Thursday, according to the CDC. There are almost 5 million long-term care residents and workers in the U.S., the CDC estimates.

It’s not clear exactly how many doses are being diverted from the program, but Illinois, for example, announced this week that it was taking 97,000 doses out of the program.

Doses upfront

Dr. Nirav Shah, director of the Maine Center for Disease Control and Prevention, said that states had to “bank a significant number of doses” for the program in the first three weeks of the vaccine rollout. The partnership was supposed to be complete within six weeks, he added, but “now has slipped into many, many more weeks.”

The slow rollout of that program, Shah said, has made the data look like Maine is leaving doses on the shelf, failing to administer all of the shots it’s been distributed when in fact the state needs more doses, not less. He added that the state is now taking back doses that were allocated for the federal partnership.

“In Maine, we are not sitting around waiting for those doses to just get used on the timetable that retail pharmacies tell us,” he said on a conference call organized by the Association of State and Territorial Health Officials. “Indeed, we are starting to withdraw those doses from the warehouses and move them into general circulation.”

Dr. Thomas Dobbs, state health officer at the Mississippi State Department of Health, echoed Shah’s frustration, saying Mississippi had to commit “the vast majority of our vaccine allocation” upfront to the federal program. The problem with the program was not just its pace, Michael Fraser, CEO of ASTHO, said on the conference call, but it was the number of doses states was expected to set aside for it.

“We had to allocate it all upfront and it’s sat idle for a long, long time,” he said.

Over-estimation

T.J. Crawford, a spokesman for CVS Health, said in an email to CNBC that allocation of doses to the program were made by tallying the number of beds in all long-term care facilities in participating states and multiplying by two to account for staff. He explained there’s now a surplus in some states because “occupancy is far less than bed count and staff uptake remains low.”

Nordlund of the CDC said the agency continues to work with states and jurisdictions to get a clearer picture of how many doses might be needed going forward.

“In some facilities, pharmacy partners wound up with surplus vaccine supply due to multiple factors including vaccine hesitancy, active Covid-19 outbreaks that impacted eligible patient counts, the ability to get six doses from the Pfizer five-dose vials, and lower than expected facility occupancy, particularly during the winter holidays,” she said.

Rick Gates, senior vice president of pharmacies at Walgreens, said in a statement to CNBC that the program is accelerating rapidly, despite a slower initial start.

“Walgreens has completed first dose vaccinations in approximately 75 percent of all long-term care facilities and remains on track to complete first doses across all facilities that selected Walgreens as their vaccine provider by mid-February,” he said. “Walgreens has conducted or scheduled nearly 70,000 clinics across long-term care facilities.”

https://www.cnbc.com/2021/02/06/states-are-taking-back-unused-covid-vaccine-doses-from-nursing-homes-.html