Monday Roundup

COVID-19 vaccine

Monday Roundup

David Ermer–CDC, COVID-19, COVID-19 vaccine, Wellness–
Photo by Sven Read on Unsplash

The FEHBlog should rename Monday’s column COVID-19 Vaccine Good News because for the fourth Monday in a row that news leads the FEHBlog.

Healthcare Dive reports that “Moderna on Monday released new study results showing the [messenger RNA based] coronavirus vaccine it developed with U.S. government scientists to be 94.1% effective at preventing COVID-19 in a large clinical trial, data the company will use to request emergency approval” from the Food and Drug Administration.

According to Moderna’s announcement

[P]rimary analysis was based on 196 cases [of COVID-19 within the test group of 30,000 individuals, half of whom received the vaccine and the other half of whom received a placebo]. 185 cases of COVID-19 were observed in the placebo group versus 11 cases observed in the mRNA-1273 [vaccine] group, resulting in a point estimate of vaccine efficacy of 94.1%. A secondary endpoint analyzed severe cases of COVID-19 and included 30 severe cases (as defined in the study protocol) in this analysis. All 30 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group. There was one COVID-19-related death in the study to date, which occurred in the placebo group.

Efficacy was consistent across age, race and ethnicity, and gender demographics. The 196 COVID-19 cases included 33 older adults (ages 65+) and 42 participants identifying as being from diverse communities (including 29 Hispanic or LatinX, 6 Black or African Americans, 4 Asian Americans and 3 multiracial participants).

The safety profile of the Phase 3 study of mRNA-1273 was previously described on November 16. A continuous review of safety data is ongoing and no new serious safety concerns have been identified by the Company. Based on prior analysis, the most common solicited adverse reactions included injection site pain, fatigue, myalgia, arthralgia, headache, and erythema/redness at the injection site. Solicited adverse reactions increased in frequency and severity in the mRNA-1273 group after the second dose.

Healthcare Dive adds that

Moderna said it will submit on Monday [today] an application for emergency use authorization in the U.S. and for conditional marketing approval in Europe. The FDA will convene a panel of independent advisers to publicly review Moderna’s application, likely on Dec. 17. * * *

An authorization for either vaccine [Pfizer – BioNTech or Moderna] would kick off a mass immunization campaign in the U.S. But supplies of each shot will be extremely limited for months. Moderna expects to have just 20 million doses available in the U.S. this year, and between 500 million to 1 billion in 2021. [Two doses protect one person. The Wall Street Journal notes that Pfizer and BioNTech said they would deliver about 25 million doses by year’s end, potentially enough for about 12.5 million people in the U.S.]

A Centers for Disease Control and Prevention advisory committee will meet on Tuesday to vote on how vaccine doses will allocated. Healthcare workers on the front lines of the pandemic will likely be vaccinated first.

The Wall Street Journal expands on this last point:

Expected to be first in line: health workers treating coronavirus patients and in something of a surprise, nursing-home residents.

The Advisory Committee on Immunization Practices, the outside medical experts advising the U.S. Centers for Disease Control and Prevention, will vote on who should get the first doses, after discussing plans for distributing the shots and monitoring for potential side effects.

In other news

  • The FEHBlog overlooked the CDC’s Antibiotic Awareness Week which was held from November 18 – 24. Better late than never right. This is an important public health cause and the link provides useful resources.
  • The FEHBlog noticed a Health Payer Intelligence article about a health plan that “has reduced out-of-pocket healthcare spending by collectively giving members millions of dollars in rewards through their My Health Pays program.” The FEHBlog did a little investigative work and he discovered that the health plan in question participates in the ACA marketplace. It is crazy that individual health plans have no limits on wellness reward uses while group health plans generally must limit their wellness rewards to reimbursing medical services and supplies or Medicare premiums. Congress should level the playing field.

Friday Stats and More

David Ermer–COVID-19, COVID-19 vaccine–

Based on the CDC’s Cases in the U.S. website, here is the FEHBlog’s chart of new weekly COVID-19 cases and deaths over the 20th through 47th weeks of this year (beginning May 14 and ending November 25; using Thursday as the first day of the week in order to facilitate this weekly update):

and here is the CDC’s latest overall weekly hospitalization rate chart for COVID-19:

The ending drop, which is found in every weekly chart, is not meaningful. The CDC’s Fluview was not updated today.

The FEHBlog has noted that the new cases and deaths chart shows a flat line for new weekly deaths because new cases greatly exceed new deaths. Accordingly here is a chart of new COVID-19 deaths over the same period (May 14 through November 25).

You will notice that FEHBlog has figured out how to more clearly present the two axes in these charts.

Although weekly new deaths continue to rise sharply, that weekly total remains below the heights reached in the Spring (shown below) even though the number of new cases in the fall (over 1 million last week) eclipse the number of new cases in the Spring (April 2 through May 13, always under 200,000 weekly):

The FEHBlog was happy to read in the Wall Street Journal that United Airlines has begun “operating charter flights to position doses of Pfizer Inc.’s Covid-19 vaccine for quick distribution if the shots are approved by regulators, according to people familiar with the matter.”

The FEHBlog plans a special Federal Benefits Open Season issue tomorrow. Stay tuned.

Tuesday Tidbits

David Ermer–COVID-19 vaccine, OPM, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

On the COVID-19 vaccination front —

  • It turns out that, according to Precision Vaccinations, the Food and Drug Administration’s “Advisory Committee on Immunization Practices (ACIP) held an out-of-schedule, emergency meeting to discuss various issues related to experimental COVID-19 vaccine candidates.” Rather than tackle the Pfizer / BioNTech vaccine emergency use authorization request the Committee primarily considered vaccination allocation issues. “During the ACIP’s Phase 1a proposed allocation plan, healthcare workers and those seniors living in Long-Term Care Facilities (LTCF), and those working for these facilities, would be the 1# priority group for vaccinations. As of November 6, 2020, LTCF residents and staff accounted for 6 percent of COVID-19 cases and 39 percent of related fatalities in the USA.”
  • STAT News adds that “Essential workers are likely to move ahead of adults 65 and older and people with high-risk medical conditions when the Centers for Disease Control and Prevention signs off on Covid-19 vaccine priority lists, coming after health care workers and people living in long-term care facilities, a meeting of an expert advisory panel made clear Monday. * * * Essential workers include people who work in meat packing plants and other food processing facilities, in municipal wastewater management operations, and in transport. It also includes police and firefighters and, in the current iteration of the ACIP’s plan, teachers. The CDC estimates there are roughly 87 million people in jobs designated as essential services.”
  • Fierce Healthcare reports that “The U.S. federal government aims to distribute 6.4 million doses of a COVID-19 vaccine to states 24 hours after it gets emergency approval, and officials are in the midst of dry runs to prepare for the shipments, officials said Tuesday. The White House’s Operation Warp Speed, a joint initiative between the departments of Health and Human Services (HHS) and Defense that aims to distribute the vaccine, gave an update to reporters Tuesday on the initial allocations of a vaccine. The update comes as emergency approval from the Food and Drug Administration (FDA) could come in the middle of December.”

MHealthIntelligence.com provides a helpful overview of the Stark, Anti-kickback Act changes rule.

According to Carrie Nixon, co-founder and managing partner of Nixon Gwilt Law, the  OIG’s Final Rule “gives healthcare providers and digital health companies more flexibility to enter into new business arrangements that incentivize care coordination and patient engagement as a means of improving outcomes and reducing the overall cost of care.”

“These new protections allow players in the digital health space – including Remote Patient Monitoring companies, telehealth companies, and healthcare predictive analytics platforms – to take on an unprecedented role in helping healthcare providers move the needle on patient outcomes and costs by providing in-kind and even monetary remuneration to these providers in the form of free or reduced cost items/services or shared savings arrangements,” she summarized in a recent article on her law firm’s website.

Deregulation is a very good thing. The FEHBlog prays that the Biden Administration does not back away from it.

The FEHBlog found OPM’s Fiscal Year 2020 Financial Report on its website today. Here’s a link.

Happy National Rural Health Day

David Ermer–CDC, COVID-19, COVID-19 testing, COVID-19 vaccine, Electronic health records, Rx coverage, U.S. Healthcare–
Photo by Tomasz Filipek on Unsplash

It is National Rural Health Day which HHS’s Health Resources and Services Administration is proud to celebrate.

The Defense Department reports on yesterday’s Operation Warp Speed press conference. The Wall Street Journal adds that

Initially, people will be vaccinated at hospitals and large medical centers because supplies will be limited, said Marion Whicker, deputy chief of supply, production and distribution at Operation Warp Speed, the federal initiative to speed development of Covid-19 drugs and vaccines. “When you see vaccines start to equal or exceed demand is when you’ll see it out of the pharmacies,” said Ms. Whicker.

According to Endpoint News, “BioNTech CEO Ugur Sahin told CNN Wednesday that they and Pfizer plan to file for an emergency use authorization for their jointly developed vaccine on Friday [/ tomorrow].

The Wall Street Journal further reports on the COVID-19 front that

U.S. hospitals say they are facing the pandemic’s largest surge armed with treatment improvements that allow them to save lives, care for more patients and accelerate the recovery of coronavirus sufferers.

HCA Healthcare Inc., one of the nation’s largest hospital chains with 186 hospitals, has more intensive-care capacity as the sickest patients recover more quickly. At the Mayo Clinic’s hospital in Rochester, Minn., coronavirus patients now stay a median of five days, half as long as in March. The time Covid-19 patients spend at Advocate Aurora Health’s 26 Midwestern hospitals has fallen 25% on average since May.

The shift could be a result of several factors and more study is needed, said doctors and researchers. But the results are consistent with anecdotal reports from doctors saying that new tools and a better understanding of how Covid-19 attacks the body are helping to improve medical outcomes.

Also HHS announced today launching

a pilot program with five states to use portable, cartridge-based COVID-19 molecular test kits that provide rapid results. The pilot program will assess how to best integrate diagnostic technology developed by Cue Health, Inc., into strategies for disease surveillance and infection control in institutions such as nursing homes.

Used successfully as the primary molecular point-of-care (POC) test to control the spread of COVID-19 within in the National Basketball Association “bubble,” as well as by leading healthcare providers in the U.S., the nasal swab POC test generates results in about 20 minutes. Currently, molecular COVID-19 tests provided by HHS must be sent to a laboratory for interpretation, which can take two to three days.

The Centers for Disease Control and the American Medical Association, the American Hospital Association and the American Nursing Association are encouraging Americans to curb holiday travel and scale back holiday gatherings due to the recent surge in COVID-19 cases. That’s a useful message for health plans circulate to members and employees.

Following up on this week’s launch of Amazon’s online Pharmacy, the Drug Channels blog comments that

This announcement is much less disruptive than it appears to be. Amazon is copying the GoodRx discount card model—including GoodRx’s partnership with Express Scripts. At the same time, Amazon is launching a mail pharmacy that will accept insurance and be in PBM pharmacy networks. Amazon’s actions are another negative headwind for retail pharmacies, but not a fatal blow to the system. Perhaps Amazon will one day become a true disrupter. For now, Amazon is choosing to join the drug channel, not fundamentally change it.

Healthcare Dive lets us in other expert insights on this development.

In other prescription drug coverage news, the Wall Street Journal reports this evening that

The Trump administration is planning on Friday [/ tomorrow] to roll out two final rules aimed at lowering drug prices—one curbing rebates paid to middlemen in Medicare and another pegging the prices of certain prescription drugs in the U.S. to their prices in other developed countries, according to a person familiar with the planning. The plans, slated to be announced in the White House Rose Garden, have been a signature pledge of President Trump’s since his 2016 election campaign. Both rules are expected to be final, meaning they have completed the required public comment period and can take effect immediately.

“Immediately” in this setting would not prevent the incoming Biden Administration from putting the brakes on the iniative without trouble, in the FEHBlog’s opinion.

In other news —

  • According to a press release, “The Sequoia Project, a non-profit and trusted advocate for nationwide health information exchange, patient identity management experts collaborated with the Blue Cross Blue Shield Association (BCBSA) to apply A Framework for Cross-Organizational Patient Identity Management for the payer community and develop person matching strategies. Today, The Sequoia Project published Person Matching for Greater Interoperability: A Case Study for Payers which demonstrates high matching accuracy rates, and provides actionable insights for improving person identity matching across the payer community, a critical component of successful health information exchange and interoperability.” Helpful.
  • According to Fierce Healthcare, “While insurers are set to weather COVID-19’s financial storm, an inability to keep up with how the pandemic is changing healthcare will be credit-negative in the long term, according to a new report from Moody’s Investors Service. The coronavirus pandemic has put a spotlight on chronic conditions, the need for continued investment in telehealth and virtual care and the drive toward value-based care, according to the report. Health plans that are able to adapt to these changing trends are far better positioned for long-term success, Moody’s said.”

Midweek update

David Ermer–COVID-19 testing, COVID-19 vaccine, Employee Wellness Programs, Uncategorized–
Photo by Manasvita S on Unsplash

More good COVID-19 vaccine news today. The Wall Street Journal reports that following up on Monday’s favorable initial report on the phase three study of their COVID-19 vaccine, Pfizer and BioNTech announced the final report on that study.

Pfizer Inc. said it will ask health regulators to authorize its experimental Covid-19 vaccine within days, after reporting the shot was 95% effective in its pivotal study and showed signs of being safe. The company’s plans, announced Wednesday, mean the shot is on track to go into distribution by the end of the year, if the regulators permit.

Pfizer and BioNTech said that of the nearly 44,000 adults in the U.S. and in other countries who took part in the study, 170 developed Covid-19 with at least one symptom. Out of those, just eight had taken the vaccine, while 162 had received a placebo. The resulting 95% effectiveness rate puts the shot’s performance on par with shingles and measles vaccines. It is also consistent with last week’s peek at how it did in an analysis of the first 94 subjects to fall sick.

The infected subjects included 10 severe cases of Covid-19, with nine in the placebo group and one in the vaccine group. The vaccine was effective across different ages, races and ethnic groups, and it was more than 94% effective in adults over 65 years old, the companies said. About 42% of the trial participants are from racial or ethnic minority groups, while 41% are ages 56 to 85, the companies said.

Moreover, medical device manufacturer Lucira Health announced today that

Late yesterday the U.S. Food and Drug Administration (FDA) authorized the first prescription molecular diagnostic test for COVID-19 that can be performed entirely at home. The FDA issued an Emergency Use Authorization (EUA) to Lucira Health, Inc. for its single-use, user-friendly COVID-19 All-In-One Test Kit that can produce a positive or negative result at home within 30 minutes. Lucira’s test kit is differentiated by its simple ‘swab, stir and detect’ design. Clinical trials showed 100% of patients were successfully able to perform the Lucira test in about two minutes. That is significantly faster than labs which currently take two to seven days to generate similarly accurate test results. The Lucira™ COVID-19 All-In-One Test Kit is expected to be available to patients served by Sutter Health in Northern California, and Cleveland Clinic Florida in Miami-Ft. Lauderdale, in the near future. By early spring 2021, it is expected to be available nationally through health care providers.

Healthcare Dive indicates that the initial price for the test will be about $50.

Benefits Pro points us to a CIGNA report titled “Health and Wellness in Workplaces: What Works? ROI Analysis of Health and Wellness Interventions” which “is the largest global review of the impact of workplace wellness interventions, according to researchers.” Top line findings are that focused wellness programs deliver the greatest impact for employers and that mental health interventions yield the most significant return on the employer’s investment.

Fierce Healthcare reports that the American Medical Association’s House of Delegates is on the warpath against employer sponsored high deductible plans. “In 2010, about 25.3% of people were enrolled in a high-deductible plan, with that number rising to 40% in 2016.” The article overlooks the important fact that participating in such a plan is the key to opening a triple tax free health savings account.

Tuesday Tidbits

David Ermer–ACA, COVID-19, COVID-19 vaccine, Rx coverage–
Photo by Patrick Fore on Unsplash

The Boston Globe reports today that

Dr. Anthony Fauci, the nation’s top infectious disease expert, said Tuesday that as many as 20 million people could get coronavirus vaccinations around the end of the year.

He said that by that time there could be as many as 25 million doses of vaccine available from Pfizer and 15 million doses available from Moderna. The vaccination takes two shots so that would mean 20 million people could get protection.

He said it could happen by the end of December, or early January if the timeline slips a bit. “That’s what we’re anticipating and hoping,” he said in an interview at the 2020 STAT Summit.

The Wall Street Journal adds that

The strong early results for two leading Covid-19 vaccines have implications that go far beyond the current pandemic: They suggest the time has come for a gene-based technology that could provide new treatments for cancer, heart disease and other infectious diseases.

The [previously] unproven technology, named messenger RNA after the molecular couriers that deliver genetic instructions, has long eluded researchers. An mRNA vaccine has never been cleared by regulators. It is now the basis for Covid-19 vaccines from Moderna Inc.  and Pfizer Inc. and its partner BioNTech SE. * * *

The mRNA vaccines’ early success [with COVID-19] “gives us some encouragement for the technology for other vaccine targets in the future,” said Dr. Mark Mulligan, director of the Vaccine Center at NYU Langone Health. 

One of the advantages of mRNA vaccines, [Biotech co-founder] Dr. [Ugur] Sahin said, is that they can be quickly adjusted so vaccines can better respond to an eventual decline in immunity or virus mutations, which could render other vaccines less effective. Dr. Sahin said that regulator authorization [of the Pfizer and Moderna COVID-19 vaccines] could potentially lead to a “whole new category of medicines.”

Hope springs eternal.

Healthcare Dive informs us that “After years of speculation, Amazon finally announced Tuesday that it will sell and deliver prescription drugs on its online platform, Amazon Pharmacy.” Moreover —

Here’s a key distinction in how Amazon Pharmacy will operate: “Before checking out customers can compare their insurance co-pay, the price without insurance, or the available savings with the new Prime prescription savings benefit to choose their lowest price option,” Amazon said.

A previously vexing problem for patients was that sometimes prescription drugs would be cheaper using cash, or without using insurance coverage. But pharmacists were sometimes barred from alerting patients to the discrepancy due to “gag clauses.” In 2018, Congress passed a bill to ban gag clauses in certain plans.

Amazon Pharmacy shoppers will be able to input their insurance information and their clinicians will be able to send prescription information directly to the Amazon Pharmacy.

Speaking of market disruption, Plan Sponsor advises us about the growing popularity of “individual coverage health reimbursement arrangements (ICHRAs) to provide their workers with tax-preferred funds to pay for the cost of health insurance coverage that workers purchase in the individual market [/ the ACA marketplace].” This is the one major Trump Administration reform to the Affordable Care Act that did not attract opposition, in court or elsewhere, because it unquestionably strengthened the ACA marketplace.

On the healthcare studies front –

  • The National Library of Medicine informs us about the susbtantial patient safety benefits of including the patient’s photograph in the top line of their electronic health record when used at healthcare facilities, particularly emergency rooms
  • The National Institutes of Health announced $21 million of funding into research examining racial and ethnic disparities in pregnancy-related complications and deaths.

According to the Centers for Disease Control and Prevention, approximately 700 women die each year in the United States from pregnancy-related complications.

Research will include original, innovative, and multidisciplinary efforts to advance the understanding, prevention, and reduction of pregnancy-related complications and deaths among disproportionately affected women. This includes women from racial and ethnic minority groups, women with underprivileged socioeconomic status, and those living in underserved rural settings.

The racial disparities in pregnancy-related mortality are stark: respectively, African American and American Indian/Alaska Native women are 3.2 and 2.3 times more likely to die from pregnancy-related causes than are white women. In the case of African American women, the disparity increases with age. Black women under 20 are 1.5 times more likely to die from pregnancy-related causes than are white women in the same age group, but black women ages 30-34 are 4.3 times more likely to die from pregnancy-related causes than are white women ages 30-34. Approximately two thirds of pregnancy-related deaths are preventable, underscoring the need for more research to improve the maternal health outcomes for women before, during, and after delivery.

In addition to maternal deaths, over 25,000 women each year experience severe maternal morbidity(link is external) (SMM), requiring unexpected short- or long-term life-saving healthcare interventions. Like maternal mortality, SMM has a high rate of preventability. All racial and ethnic minority populations have higher rates of SMM than do white women.

Monday Roundup

David Ermer–COVID-19, COVID-19 vaccine–
Photo by Sven Read on Unsplash

The light at the end of the COVID-19 tunnel got brighter this morning when prescription drug manufacturer Moderna announced strong efficacy results from its COVID-19 vaccine which, like the Pfizer vaccine, is based on messenger RNA technology. Healthcare Dive explains

The results are from an early look at a clinical trial of 30,000 volunteers recruited at nearly 90 hospitals and clinics across the country. An independent committee overseeing the trial found Moderna’s vaccine was 94.5% effective at preventing COVID-19 compared to a placebo. Their analysis was based on 95 cases of COVID-19, 90 of which occurred in participants given the placebo versus just five among those who received the vaccine. Crucially, while 11 participants given the placebo developed severe COVID-19, there were no such cases in vaccinated individuals, suggesting inoculation protects against the worst symptoms of the disease.

According to its announcement, Moderna will be seeking emergency use authorization from the Food and Drug Administration next month. The company’s request for FDA approval will follow in the first quarter of 2021. What’s more per Healthcare Dive

Pfizer and BioNTech’s shot has to be transported and stored at minus 70 degrees Celsius, or about 94 degrees Fahrenheit. Once thawed, doses can be stored for five days at temperatures between 2 and 8 degrees Celsius. Those limitations may make it difficult for community clinics and pharmacies to store and administer the shot.

Moderna’s vaccine, by comparison, must be stored and shipped at minus 20 degrees Celsius. The company said Monday new data indicate the vaccine can be refrigerated at between 2 and 8 degrees Celsius for up to 30 days, longer than the 7-day stability Moderna previously disclosed and an advantage that could permit broader use.

Moderna also is participating in the federal government’s Operation Warp Speed which will facilitate vaccine manufacturing and distribution.

Moderna’s CEO explained on Fox Business this morning that its vaccine will be available to people at 18 and older once EUA is obtained. Moderna plans to test the vaccine on younger teenagers next year in an effort to achieve FDA approval for using the vaccine on the younger group before the 2021 school year starts.

The Wall Street Journal’s most popular article today is titled “As Covid-19 Surges, the Big Unknown Is Where People Are Getting Infected.” That’s a question that has cross the FEHBlog’s mind more than once.

Jay Varma, senior adviser for public health in the New York City mayor’s office, said 10% of the city’s infections are due to travel, 5% from gatherings, and another 5% from institutional settings such as nursing homes. “The vast majority of the remainder—somewhere probably around 50% or more—we don’t have a way to directly attribute their source of infection,” Mr. Varma said. “And that’s a concern.”

The upshot of the article is that public health authorities in the U.S. need to engage in better contact tracing.

[M]ost contact-tracing systems set up to investigate infections haven’t been identifying enough contacts to map how the virus spreads. And whatever data they generate isn’t always being mined to inform how to craft more discriminating lockdowns. Asian nations that have used contact tracing successfully to control the disease interview 10 or more contacts for each case. In the U.S., France, the U.K. and Spain, tracers are identifying fewer than four contacts for each case, according to government data.

America’s Health Insurance Plans (“AHIP”) today properly criticizes Congress for opening to door to provider price gouging for out of network COVID-19 tests by conditioning health plan coverage simply on posting prices online.

In October 2020, AHIP conducted a second survey of health insurance providers in the commercial market to gather information on prices charged by out-of-network providers for diagnostic, antibody, and antigen tests for COVID-19.1 The survey found that almost a quarter (23%) of all claims for COVID-19 tests were from out-of-network test providers. And many out-of-network test providers charged prices for COVID-19 tests that far exceeded the average cost of in-network tests ($130).

Everyone should be able to get the COVID-19 tests they need, whether they have health insurance coverage or not. To stop price gouging:
• Congress should make the financial investment needed to ensure that Americans have access to all necessary COVID-19 testing.
• Congress should eliminate the ability for price gouging to occur by setting a reasonable market-based pricing benchmark for tests delivered out of network.
• Policymakers should accelerate the availability of consumer-friendly, rapid, and accurate tests that lower costs and mitigate the capacity and supply constraints of providers and labs.
• The Administration should ensure that all available COVID-19 tests, both manufacturer-developed and laboratory-developed, meet appropriate standards for accuracy.

Amen to that.

AHIP also offers a useful infographic on how health plan premiums spent by breaking a dollar into its component expenditures.

Highlights from the research include:

  • Medication and medical services accounted for 81.6 cents of the health care premium dollar.
  • 21.5 cents are used to pay for prescription drugs.
  • 19 cents are used to pay for in-patient hospital costs, while 19.8 cents are used to pay for out-patient hospital costs.
  • 12.1 cents are used to pay for doctors’ visits.
  • 4.6 cents are used to pay for federal, state, and local taxes.
  • 2.4 cents are used to pay for the prevention of fraud, waste, and abuse.
  • Only 3 cents of every health care dollar go toward health insurance provider profits.

Performing this breakdown on a dollar of FEHBP premiums is complicated by the fact that the FEHBP has a large cadre of Medicare prime annuitants, over 70% of whom also carry both Medicare Parts A and B. For these folks, Medicare pays the bulk of their hospital and doctors expenses while the FEHBP pays their prescription expenses.

Consequently raw FEHBP prescription drug spending is overstated and FEHBP hospital and doctors visits spending is understated. In the final analysis, if you take into account this Medicare cost shifting, the FEHB and AHIP dollar breakdowns should be in rough alignment, with one caveat. For experience rated plans, e.g., Blue Cross FEP and GEHA, which cover the majority of FEHB enrollees, less than one cent of every health care dollar go toward gross profit under OPM’s rules.

Thursday Miscellany

David Ermer–COVID-19 vaccine, OPM, Rx coverage, SCOTUS–
Photo by Juliane Liebermann on Unsplash

OPM has posted an announcement about the beginning of the Federal Benefits Open Season which kicked off last Monday and the NIH Director Dr. Francis Collins offers guidance on how to celebrate the upcoming holidays with exposing yourself to COVID-19.

To illustrate that the Pfizer COVID-19 game in town vaccine is not the only game, Fierce Healthcare offers articles on two candidate which offer greater pre-administration stability, one by CureVac and the other by Johnson & Johnson.

Leaning on its years of experience, the drugmaker is well on its way to producing 1 billion doses of its COVID-19 vaccine in 2021 and is looking ahead to 2022, said Paul Lefebvre, VP of strategic initiatives and COVID-19 vaccine supply chain at J&J’s Janssen unit, in an interview. 

J&J’s shot could have a storage and distribution edge over the likes of those from Pfizer and BioNTech, Lefebvre thinks. 

“In our plans, we will bring our product at -20° C into the J&J warehouses around the world,” he said.

J&J’s shot is expected to remain stable for up to two years at that temperature, about -4° Fahrenheit. Once it goes out to distributors and customers, it can be kept stable at 2 to 8° Celcius (a range of about 35.6° to 46.4° Fahrenheit) for up to three months, not much colder than your average refrigerator, Lefebvre said. 

As previously noted, the COVID vaccine manufacturers will seek emergency use authorization (“EUA”) from the Food and Drug Administration follow the completion of the phase III trial. Phrma, the drug manufacturer trade association, provides readers with an understanding of FDA EUA.

The FDA may issue an EUA, when, among other things, the agency determines that based on all of the available scientific evidence, the known and potential benefits of the vaccine outweigh the known and potential risks. To underscore this, FDA Commissioner Stephen Hahn has said repeatedly in recent weeks and months that the agency would only consider an EUA if it felt the risks associated with the vaccine were “much lower than the risks of not having a vaccine and the potential benefit of having a vaccine.”

The agency has further taken steps to ensure the robust vaccine candidate review process by engaging the Vaccines & Related Biological Products Advisory Committee (VRBPAC) to discuss the development and potential authorization of vaccines to prevent COVID-19 after issuing guidance on FDA’s recommendations for an EUA submission for a COVID-19 vaccine.­

The Department of Health and Human Services announced today its partnerships with chain and independent pharmacies to administer the COVID vaccines as the vaccines received EUA and are made available to the public under the government allocation plan, which kicks off with first responders.

In prescription drug benefit news,

  • Drug Channels is offering its “annual deep dive into employer-sponsored coverage for prescription drugs,” and
  • Good Rx unveils the 2021 changes in popular CVS Health and Express Script formularies.

Finally, the FEHBlog wants to call attention to Katie Keith’s excellent analysis of last Tuesday’s Supreme Court argument in the California v. Texas case. Although Ms. Keith does not project an outcome, the FEHBlog is comfortable stating that the Supreme Court will preserve the Affordable Care Act for the third time, except perhaps for the zeroed out individual shared responsibility provision, which already is a dead letter.

Tuesday Tidbits

David Ermer–AHRQ, Congress, COVID-19, COVID-19 vaccine, OPM, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

The FEHBlog spent two hours this morning listening to the oral argument in the latest Affordable Care Act (“ACA”) constitutionality case to reach the U.S. Supreme Court, California v. Texas (No. 19-840). This activity resulted in the FEHBlog learning a new word hortatory and receiving confirmation that his hunch is correct, to wit, There is no chance that the Supreme Court will disrupt the ACA status quo as a result of this case. Indeed the Supreme Court clearly took the case to preserve, not disrupt, the status quo. If you are interested, Amy Howe from the SCOTUSblog has written a legal analysis of the oral argument.

Following up on yesterday’s good news about Pfizer’s COVID-19 vaccine, the Wall Street Journal informs us that

In Kalamazoo, Mich., Pfizer has turned a stretch of land the size of a football field into a staging ground outfitted with 350 large freezers, ready to take delivery of millions of doses of Covid-19 vaccine before they can be shipped around the world.

To make sure its Covid-19 vaccine doses arrive at hospitals and clinics frozen and potent, Pfizer created its own container to ship them.
The temperature-controlled container can store between 1,000 and 5,000 doses for 10 days at minus 70 degrees Celsius before requiring re-icing.

From that site, and another in Puurs, Belgium, the pharmaceutical giant said it wants to deliver up to 100 million doses this year and another 1.3 billion in 2021.

One person needs two doses of the vaccine in order to be protected, again assuming that the phase III study of the vaccine remains on its currently successful course.

The Journal further reports that

U.S. health officials on Monday authorized use of the first treatment for people with earlier-stage Covid-19 who aren’t hospitalized, filling a gap in treatment.

The U.S. Food and Drug Administration said Eli Lilly LLY 2.97% & Co.’s antibody drug should be used for patients ages 12 and up with mild to moderate Covid-19, based on a study showing it helped improve symptoms and kept many patients out of the hospital.

The drug is named bamlanivimab [and it is infused into the patient]. Lilly said it will begin shipping the drug immediately to AmerisourceBergen Corp. ABC 3.59% , a national drug distributor, to distribute it as directed by a federal allocation program [which is described in this HHS announcement issued today].

The Journal also discusses ongoing U.S. problems with COVID-19 testing

The U.S. is running more Covid-19 tests each day than at any other point during the pandemic, but the increased testing doesn’t fully explain recent case surges across the nation, data show. Altogether, testing data suggest Covid-19 diagnostic tests are still severely underused in the U.S. And inconsistencies in data collection and reporting systems are hampering efforts to understand and contain the virus’s spread as the holidays approach, public health and testing executives say.

Because the FEHBP covers a large cadre of senior citizens, it is worth pointing out this AHRQ funded report finding that

Healthcare costs for seniors who needed emergency services after a fall averaged $26,143 in the year following the event, according to an AHRQ-funded study published in The Journal of the American Geriatrics Society. Those costs significantly exceeded the average $8,642 in healthcare costs in the year prior to the event

In civil service news,

Federal employees would not receive an across-the-board increase in pay next year under provisions outlined in a series of fiscal year 2021 funding bills released by the Senate Appropriations Committee Nov. 10. Unlike FY2021 funding passed in the House earlier this year — which simply did not include any provision addressing federal pay — the Senate bill actively sets 2021 pay levels at the same rate as 2020. That difference would override any planned pay increase out of the White House, which was set at 1 percent in President Donald Trump’s February budget proposal.

The Senate is pushing through these measures in order to create a baseline for negotiating an omnibus continuing resolution with the House, which has completed its appropriations bills work, before the current continuing resolution expires on December 11.

  • Federal News Network reports on the Biden Administration’s transition team. Of note,

Kiran Ahuja, a former chief of staff at the agency, will lead the OPM team. Ahuja served at OPM during the aftermath of the agency’s cybersecurity breaches. Prior to her OPM service, she led the Obama administration’s White House Initiative on Asian Americans and Pacific Islanders. Today, she’s the CEO of Philanthropy Northwest, a non-profit organization. The rest of the team is filled with OPM alums who served at the agency as senior advisors during the Obama administration.

Monday Roundup

David Ermer–ACA, CDC, COVID-19, COVID-19 vaccine, SCOTUS–
Photo by Sven Read on Unsplash

Perhaps at last we are beginning to see the light at the end of the COVID-19 tunnel. Pfizer announced positive initial results from the phase three trial of its two dose COVID-19 vaccine.

“Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19,” said Dr. Albert Bourla, Pfizer Chairman and CEO. “We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen. With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.”

The Wall Street Journal explains (in part) that ‘

“When will the Pfizer vaccine be ready for [emergency use] authorization?

“It will be several more weeks at the earliest, because researchers and regulators still need to make sure the shot is safe. The U.S. Food and Drug Administration has said it wants to see two months’ worth of safety outcomes after vaccination for at least half of the people participating in any large, final-stage clinical trial before it considers authorizing a Covid-19 vaccine. The FDA says this will allow identification of any side effects, such as neurological or heart conditions, that weren’t apparent immediately after vaccination. So far, no serious safety issues have been found, Pfizer says. It expects the two months of safety data later this month, and can ask the FDA to authorize the vaccine soon thereafter. It isn’t yet clear how long the FDA will take to make a decision.

“When will people start getting vaccinated?

“Shots from Pfizer and BioNTech could start becoming available before the end of the year, as production has already begun, but initial supplies will be limited. Pfizer says it expects to produce up to 50 million doses globally in 2020—enough for 25 million people because the vaccine is given in two doses—and up to 1.3 billion doses in 2021. This means only the highest risk groups, such as front-line health care workers, could be inoculated this year. Many more doses would be needed to cover the U.S. and global population. Other Covid-19 vaccines in development will likely be needed for everyone to get vaccinated. Their makers have projected they could produce billions of doses next year if their vaccines are successful in clinical testing.”

The Centers for Disease Control released a study of hospital readmissions of COVID-19 patients from March through July 2021.

Among 126,137 unique patients with an index COVID-19 admission during March–July 2020, 15% died during the index hospitalization. Among the 106,543 (85%) surviving patients, 9% (9,504) were readmitted to the same hospital within 2 months of discharge through August 2020. More than a single readmission occurred among 1.6% of patients discharged after the index hospitalization.

The CDC also offered us guidance on avoiding COVID-19 during the Thanksgiving holidays.

The Centers for Medicare and Medicaid Services (“CMS”) released Affordable Care Act medical loss ratio rebate data from the latest health insurer reports for the three year period ending in 2019. The medical loss ratio data is broken out into three cohorts — individual insurance (minimum MLR 80%), small group insurance (minimum MLR 80%), and large group insurance (minimum MLR 85%). Each cohort then is further broken down state by state which no doubt increase the rebates. FEHB plan insurer rebates sensibly are paid to the the carrier’s contingency reserve, which is FEHB lingo for a premium stabilization fund.

Katie Keith in the Health Affairs blog offers her insights into tomorrow’s California v. Texas oral argument before the U.S. Supreme Court. C-SPAN will play the audio live on radio and the internet.

“The main issues to listen for are:

  • “Do the challengers—a coalition of states led by Texas and two individuals—have standing to challenge the ACA?
  • “Is the individual mandate, with a $0 penalty, unconstitutional?
  • “If the mandate is unconstitutional, is it severable from the rest of the ACA? If not, which other ACA provisions should be struck down alongside the mandate?”