FEHBlog

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.

Weekend update

David Ermer–Congress, COVID-19, HSA–

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

David Ermer–COVID-19, Federal employment benefits, OPM–

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.

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.

Happy Veterans Day

David Ermer–COVID-19, OPM, U.S. Healthcare–
Thanks to Aaron Burden for sharing their work on Unsplash.

Fedweek reminds us that “With just about a third of federal employees having also served in [the U.S. military], today is an especially important day in our community. Thanks for your service.

Healthcare Dive cumulates its reporting on health insurer third quarter 2020 financial results.

In the third quarter, insurers saw a slight dampening from the record-high profits [which of course are constrained by the ACA MLR and OPM’s even stricter FEHB MLR] recorded in the previous quarter as medical utilization rebounded to about 95% of normal volumes for most major payers.

They warned, however, that tailwinds may not last as people seek previously deferred care in the fourth quarter and into next year. Another widespread halting of elective procedures is unlikely as providers have learned more about safely carrying out routine care despite COVID-19 surges.

But novel coronavirus case rates and hospitalizations have reached record levels nationwide this week and it’s unclear how safe people will feel returning to hospitals and doctor’s offices for non-emergent treatments.

Good point.

The Wall Street Journal warns that

Hospitals across the nation face an even bigger capacity problem from the resurgent spread of Covid-19 than they did during the virus’s earlier surges this year, pandemic preparedness experts said, as the number of U.S. hospitalizations reached a new high.

The number of hospitalized Covid-19 patients Tuesday reached 61,964, according to the Covid Tracking Project, passing the prior record of nearly 60,000 in April as the virus surged in the northeast. Hospitalizations hit a nearly identical peak again in late July, as the pandemic’s grip spread across the South and West.

Epidemiologists said the record is likely to be swiftly replaced by another as Covid-19 cases soar nationally. “We already know this is going to go far north,” said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

Fierce Healthcare adds that

Health IT giant Epic has rolled out a new tool for hospitals that helps predict patients’ likelihood of testing positive for COVID-19. The COVID-19 risk prediction model was designed by Cleveland Clinic researchers and was developed and tested using clinical data from more than 11,000 patients. The model uses information from patients’ comprehensive health records combined with patient-entered information in Epic’s patient-facing app, MyChart, to show an individual’s likelihood of testing positive for COVID-19.

Finally on the FEHBP front, FEDWeek reports that

OPM has issued guidance on removing ineligible family members from coverage under the FEHB program, stressing that under its rules, either an employing agency, OPM or an FEHB carrier may “request proof of family member eligibility from an employee at any time for existing enrollments.”

In a pair of similar messages to agencies and to carriers, OPM set the process for requesting proof of family member’s eligibility for existing enrollments, what documents may be used as proof, what actions can be taken based on the response, and the process for reconsidering a decision to remove someone from coverage. Carriers are to inform employing offices in order to avoid duplicate requests for verification, it added, and carriers are to be “judicious in exercising this authority.”

Honestly, it is the employer’s responsibility to police its eligibility rolls. Around five years ago, OPM added a provision to the FEHBP standard contract requiring carriers to pay the freight for an OPM contractor to audit eligibility rolls for ineligible family members. However, OPM has not implemented this clause to date.

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?”

Weekend Update

David Ermer–Congress, COVID-19, OPM, SCOTUS, U.S. Healthcare–

The House and the Senate are resuming some Committee work this coming week. The Senate may be conducting floor votes but the House will not resume floor voting until next week. Wednesday November 11 is a federal holiday for Veterans’ Day.

Tuesday morning will feature the oral argument in the latest Affordable Care Act constitutionality case, California v. Texas (No. 19-840). The argument will proceed as follows beginning at 10 am:

  • 30 minutes for California, et al.,
  • 10 minutes for the U.S. House of Representatives,
  • 20 minutes for the Solicitor General, and
  • 20 minutes for Texas, et al. 

Of course, the FEHBlog will be listening to the oral argument and he will report his observations on Tuesday. The FEHBlog enjoys the live audio version of the Supreme Court’s oral arguments because the Justices ask questions in order of seniority following the Chief Justice. If you want to listen in too, here’s a link to C-SPAN website which will send you a reminder if you share your email address.

The Centers for Medicare and Medicaid Services did fix their broken link to the 2021 Medicare premium and cost-sharing changes fact sheet over the weekend. Here’s an active link for your information.

Of course, the Federal Benefits Open Season begins tomorrow and runs through December 14. Good luck to all.

Kaiser Permanente released its third quarter 2020 financial results last Friday.

“Although the pandemic continues to have an impact on Kaiser Permanente, during the third quarter we safely resumed in-person preventive and elective care, started to address the backlog of deferred procedures that were put on hold due to COVID-19, and continued to leverage and grow virtual care for members’ safety and convenience,” said executive vice president and chief financial officer Kathy Lancaster.

NPR Shots offers a useful overview of COVID-19 cases and deaths similar to the CDC and it offers a preview of the Biden Administration’s approach to the pandemic.

On Monday, I will name a group of leading scientists and experts as transition advisers to help take the Biden-Harris COVID plan and convert it into an action blueprint that starts on Jan. 20, 2021,” Mr Biden said last night in a public address.

A Biden spokesperson told NBC’s Meet The Press Sunday that the coronavirus task force will be led by former Surgeon General Dr. Vivek Murthy and Dr. David Kessler, who led the Food and Drug Administration during the 1990s.

“We have to function as one nation. That means having a national plan,” Dr. Murthy, a key adviser to the Biden campaign, told NPR recently.

Friday Stats and More

David Ermer–COVID-19, Medicare, Rx coverage, U.S. Healthcare–

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 44th weeks of this year (beginning May 14 and ending November 4; 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 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 4).

On the flip side, also according to the CDC, “seasonal influenza activity in the United States remains low.”

Fierce Biotech discusses the progress of a Humanigen investigation new drug called lenzilumab which is undergoing a phase 3 trial.

If the trial succeeds, lenzilumab could emerge as part of the arsenal for treating some of the sickest COVID-19 patients. Lenzilumab may stop cytokine storms, the severe hyperimmune responses that drive organ damage in some COVID-19 patients. Currently, physicians treat such severe patients with steroids and Gilead’s remdesivir, but there remains a need for more efficacious therapies. 

The chances of anti-SARS-CoV-2 antibodies meeting that need have diminished in recent weeks as prospects in development at Eli Lilly and Regeneron have failed in severe COVID-19 patients. Efforts to use existing drugs, notably anti-IL-6 antibodies such as Sanofi’s Kevzara, to stop cytokine storms in COVID-19 patients have also failed. 

In other investigational drug news, the Boston Globe reports that

Biogen Inc.’s experimental Alzheimer’s disease therapy [mentioned in the FEHBlog earlier this week] failed to gain support from a panel of US Food and Drug Administration advisers on Friday, putting the drug at a crossroads as the agency weighs approval.

The outside experts voted 8 to 1, with 2 undecided, that data from a single clinical trial with positive results was insufficient to show Biogen’s drug works. The vote contradicts a report FDA reviewers prepared ahead of the meeting that supported the efficacy of the drug, called aducanumab, though there was dissent in the agency. * * *

The advisory committee’s recommendations aren’t binding. The FDA often calls on panels of experts, including researchers, medical professionals and patient representatives, when it is considering whether to approve a new drug. Wall Street analysts said the FDA seemed set on viewing the drug positively.

“This will be a test for the FDA on what happens when the FDA is on one extreme and the panel is seemingly on the other, with science and evidence or the lack thereof being at the core of discussion,” Mizuho analyst Salim Syed said in an email to Bloomberg News.

At long last (given the fact that the Medicare Open Season stated on October 15), the Centers for Medicare and Medicaid Services this afternoon announced Medicare Part B premiums and Parts A and B cost sharing changes for 2021:

  • The standard monthly premium for Medicare Part B enrollees will be $148.50 in 2021, an increase of $3.90 from $144.60 in 2020.  The fact sheet that would show income adjusted premiums for high earners was unavailable online this evening. Check again here on Sunday.
  • The Medicare Part A inpatient deductible that beneficiaries will pay when admitted to the hospital is $1,484 in 2021, an increase of $76 from $1,408 in 2020. 
  • The annual deductible for Medicare Part B beneficiaries is $203 in 2021, an increase of $5 from $198 in 2020.

CVS Health not only announced third quarter earnings today; it also disclosed that its current CEO Larry Merlo is retiring and Karen Lynch, who currently heads the Aetna business unit, will replace him. Congratulations to both of them. Healthcare Dive adds

CVS’ medical loss ratio was 84%. That’s compared to just 70.3% in the second quarter as consumers deferred non-essential care amid COVID-19.

CVS has now administered more than 6 million COVID-19 diagnostic tests across 4,000 testing sites, representing 70% of all testing done in retail settings, Merlo said.

Health Payer Intelligence discusses how “Blue Cross and Blue Shield of Illinois (BCBSIL) has partnered with hospitals across the state in a new program that seeks to pursue health equity by focusing on mitigating health disparities for racial and ethnic minorities.” Well done.