Friday Stats and More

Friday Stats and More

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

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.

Monday Roundup

Photo by Sven Read on Unsplash

Another Monday, another COVID-19 vaccine — the newest from Oxford University (UK) and Astrazeneca. The Times of London reports that

Oxford University scientists said this morning that they had created “a vaccine for the world” as trial results showed that their Covid-19 jab worked well enough to apply immediately for regulatory approval.

The vaccine involves two injections, administered at least a month apart, and the results suggest that using a lower first dose could boost efficacy to 90 per cent. However, that finding relied on limited data and may be amended.

Overall, a trial involving 24,000 people suggested that the vaccine was about 70 per cent effective.

It prevented severe disease and the need to be admitted to hospital, and there are promising early signs that it might also block transmission of the virus. No dangerous side-effects were reported, and the British medical regulator has begun to review safety and efficacy data.

Britain has ordered 100 million doses, and Astrazeneca, the drug company that is working with Oxford, said this morning that four million of those would be ready to be sent to care homes, GP clinics and other vaccination centres by the end of the year.

The Oxford vaccine can be stored in a normal fridge, making it easier to handle than Pfizer’s competing inoculation, which must be stored at about minus 70C. It is also considerably cheaper, costing a few pounds per dose. It is possible that the first doses could be administered before Christmas.

The FEHBlog heard on Fox Business this morning that a separate phase three trial for the Oxford vaccine is ongoing in our country. Oxford and Astrazeneca will present an emergency use authorization request to our Food and Drug Administration (“FDA”) based on that as yet uncompleted trial. The trial referenced in the Times of London article was conducted in the United Kingdom and Brazil. The FDA does not require that the phase three trials be conducted in the U.S. For example, the agency approved the Ebola vaccine based on a phase three trial conducted in Africa, but of course there’s no problem finding COVID-19 patients here.

Reuters reports that the FDA’s Vaccines and Related Biological Products Advisory Committee will meet on December 10 to review the Pfizer / BioNTech emergency use application for its COVID-19 vaccine. The FDA is not bound by the Committee’s recommendation. Here is a link to the full FDA press release.

A friend of the FEHBlog recommended the 20 minute long Journal podcast interview with the founder of BioNTech Dr. Ugur Sahin. The FEHBlog found that podcast fascinating listening.

Govexec.com reports that “The departments of Defense and State, as well as the Veterans Affairs Department’s Veterans Health Administration, the Bureau of Prisons and Indian Health Service, will all receive a direct allocation of vaccines from the Centers for Disease Control and Prevention. The plan was spelled out in a COVID-19 Vaccination Program Interim Playbook, which was first reported by CNBC.” 

Following up on the major Health and Human Services rule makings on Fridays here are article with industry reaction:

  • As the FEHBlog expected, Fierce Healthcare reports that “A hurried final rule aimed at tying drug prices to those paid by foreign countries could lead to providers paying more for drugs than what they will get reimbursed by Medicare, according to several providers and experts.” It really makes you wonder why the American Medical Association’s House of Delegates conditionally endorsed adding a public option to the ACA marketplace earlier this month.
  • Fierce Healthcare further informs us that “CMS’ Stark, anti-kickback updates draw praise from hospitals, concern from physician groups.”
  • Health Payer Intelligence discusses the Medicare rule restricting the use of prescription drug rebates in Medicare Part D effective January 1, 2022. The FEHBlog cannot understand why if drug manufacturers want to end the rebate practices, it does not assure (with an enforcement mechanism) the health insurance industry and the government that the price reductions will balance out the lost rebates.

Friday Stats and More

Based on the CDC’s COVID-19 Data Tracker website, here is the FEHBlog’s chart of new weekly COVID-19 cases and deaths over the 20th through 46th weeks of this year (beginning May 14 and ending November 18, roughly six months; using Thursday as the first day of the week in order to facilitate this weekly update):

The upward surge in COVID-19 cases is reflected the CDC’s latest overall weekly hospitalization rate chart for COVID-19 (disregards the dip at the right side of the chart):

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 six month long period (May 14 through November 18) (the dip at the tail of this chart is accurate information).

Meanwhile the CDC’s weekly flu surveillance report continues to inform us that “Seasonal influenza activity in the United States remains lower than usual for this time of year.” Better one epidemic than two.

On the bright side, according to the Wall Street Journal, Pfizer and BioNTech did file an emergency use authorization request for their COVID-19 vaccine today.

Now it will be up to the U.S. Food and Drug Administration to decide whether the two-shot vaccine works safely enough to roll out to millions of people.

It is unclear how long the agency will take to review the vaccine, which Pfizer and BioNTech just days earlier said was 95% effective and well-tolerated in a 44,000-subject trial.

Given the urgency, the FDA is expected to move quickly. The timing of the filing is in line with industry and government officials’ projections for authorization and distribution to begin next month. Pfizer said the filing could allow for distribution to begin the middle to end of December.

The Health and Human Services Department (“HHS”) released a string of final rules today affecting Medicare prescription drug plans and both hurting and helping the finances of doctors participating in Medicare and certain other federal health programs (but thankfully not the FEHBP). As the saying goes, he who lives by the sword can die the sword.

  • HHS issued a final rule generally barring the use of prescription drug rebates in the Medicare Part D program effective January 1, 2022.
  • HHS issued another final rule that implements, effective January 1, 2021, a pilot program”, known as the Most Favored Nation (MFN) Model, [that] will test [for seven years] an innovative way for Medicare to pay no more for high cost, physician-administered Medicare Part B drugs than the lowest price charged in other similar countries.”
  • Finally. HHS issued a final rule which loosens up on self-referral a/k/a Stark Act rules that inhibit the entrepreneurial spirit of doctors participating in Medicare. The purposes of the change is to facilitate value based pricing and coordinated care. Doctors should like this one but the FEHBlog wonders whether the AMA will think that it goes far enough.

Of course, we also will have to wait to see the incoming Biden Administration’s reaction to these rules.

Healthcare Dive discusses conflicting viewpoints on AHIP’s position which the FEHBlog shares that the COVID-19 relief law Wild West approach to health plan coverage of out-of-network COVID-19 leads to price gouging. Only Congress can fix this problem.

Speaking of Congress, Govexex.com reports that

Congressional leaders have voiced early speculation in recent days that lawmakers will be able to set line-by-line funding levels for agencies throughout government before the end of the year without the need for another stopgap measure. 

Top negotiators in the House and Senate met on Thursday to discuss a potential compromise for the rest of fiscal 2021 appropriations. On Friday, House Speaker Nancy Pelosi, D-Calif., was the most recent leader to cautiously express optimism that Congress can pass a full-year, omnibus spending bill before the current continuing resolution expires Dec. 11. 

“The anticipation was that it was really about the omnibus,” Pelosi said of the meeting. “You have to remember, we have to have an omnibus bill. We must keep government open.” She added it was a “very important responsibility” during the lame duck session of the 116th Congress. “We don’t want another continuing resolution. I don’t think they do either.”

Finally, the FEHBlog was impressed by Humana CEO Bruce Broussard’s call for health system interoperability without further delay. Mr. Broussard is Board Chair of America’s Health Insurance Plans for 2021. Here’s a snippet.

Change requires reforming the incentive structure to encourage and require vendors to create and sell systems that can talk to each other. Health care systems, hospitals, and physician practices — guided or encouraged by the market and the federal government — should choose interoperable systems. Public and private payers should implement value-based payment models that reward the purchase and use of interoperable systems. It’s also up to the federal government to implement and enforce standards for EHR vendors that promote interoperability while simultaneously strengthening the protection of personal health information.

If industry and government don’t lead the charge to make America’s health care system interoperable, consumers will bear the challenge of piecing together their own health data across the system — a dangerous prospect that could hinder patient care in the midst of a global pandemic. The free flow of protected data across the health care system ensures that treatment decisions are informed safely and effectively by the most current information available and tailored to the individual. A clinician with complete information at her fingertips can easily see the full picture and manage her patient’s care from the hospital to the pharmacy to long-term follow-up care.

This pandemic will eventually end. But the need for interoperability will remain urgent as we seek long-term solutions to bring down costs, improve care delivery, and increase efficiency in our health care system.

There’s no time like the present.

Happy National Rural Health Day

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

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

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

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.

Weekend update

Both Houses of Congress will be engaged in committee work and floor voting this coming week, the last full workweek before Thanksgiving week. CNET provides an update on the likelihood of Congress passing another COVID relief bill during this lame duck session. The most pressing lame duck session legislative action is addressing federal government funding which expires after December 11 absent Congressional action. Currently the last day for House voting in 2020 is December 10.

Following up on Friday’s COVID-19 stats discussion, Govexec.com provides estimates of COVID-19 cases afflicting federal employees and military members.

More than 100,000 federal personnel have now tested positive for COVID-19, nearly triple the total in mid-July. Almost 3% of government workers across the military and civilian agencies have now contracted the virus. About 50,000 civilian workers have tested positive, in addition to more than 62,000 members of the Armed Forces.

Earlier today the Centers for Disease Control reported that just under 10.85 million Americans have contracted COVID-19 this year. The current U.S. population is roughly 331 million people. Consequently, the federal employee COVID-19 contraction rate aligns with the total U.S. rate (3.27%). That’s good news in the FEHBlog’s opinion, considering the fact that a sizable percentage of federal employees and military members have contact with the public as part of their responsibilities.

As we enter the second week of the Federal Benefits Open Season, the FEHBlog deems it appropriate to call attention to this helpful Wall Street Journal article titled “It’s Open-Enrollment Season. Is an HSA Still Right for You?” Helpful tidbit from the article:

Roy Ramthun, a consultant who specializes in high-deductible plans and HSAs, recommends conducting a “worst-case-scenario” analysis. This shows which plan would be most cost-effective in the event an employee spends so much he or she hits the plan’s out-of-pocket spending limit. (After that, the plan becomes responsible for 100% of expenses for the rest of the year.)

Assume Ms. [Employee’s]’s family continues to stick largely with doctors and hospitals that take their insurance on an “in-network” basis. The high-deductible plan could make them responsible for $8,000 in out-of-pocket spending—a number that includes the plan’s $4,000 deductible. Some of the blow would be offset by the $5,500 Ms. [Employee] stands to save in premiums and employer contributions.

In contrast, the annual out-of-pocket maximum with the conventional plan is even higher, at $9,000, providing less protection against high medical bills. As a result, the high-deductible plan is the mathematical winner in this scenario, as well. (Mr. Ramthun recommends repeating this exercise using the two plans’ out-of-network spending limits.)

These numbers by the way are not derived from FEHB plans.

Friday Stats and More

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 45th weeks of this year (beginning May 14 and ending November 11; using Thursday as the first day of the week in order to facilitate this weekly update):

That’s an eyepopper. 700,000 new cases in one week. Interestingly the CDC’s flu surveillance report as of November 7 continues to state that “Seasonal influenza activity in the United States remains low.” Twin epidemics of course would be worse.

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 11).

It’s worth adding that the highest number of weekly deaths occurred just before the start of this chart on May 14. Here a chart covering the period from April 2 through May 13, 2020.

Consequently, while new cases now are skyrocketing, current new weekly deaths (a weekly average of 5,473 over the past six weeks) are significantly lower than the above six week time frame (a weekly average of 10,408). That indicates to the FEHBlog that medical care is improving.

In other news —

  • Govexec.com offers Open Season decision making advice from the folks who write the Consumers’ Checkbook “Guide to Health Plans for Federal Employees.” While OPM with carrier input has made great strides in improving its FEHB plan comparison tool. the Checkbook Guide remains the gold standard in the FEHBlog’s opinion. The FEHBlog does purchase the Checkbook Guide and the price is around $11 for online access.
  • FedWeek provides more names on the Biden Administration OPM “landing team.” The FEHBlog is not familiar with any of them for what that’s worth.