Midweek update

COVID-19 vaccine

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?”

Midweek update

David Ermer–Congress, COVID-19 vaccine, Telehealth–
Photo by Manasvita S on Unsplash

The Hill brings us up to date on the status of bipartisan negotiations over a COVID-19 relief bill. At least the negotiated bill may be teed up for the lame duck session of Congress next month.

On Monday, Healthcare Dive reported the CVS Health is hiring 10,000 pharmacy technicians to administer vaccinations and today, and today

the U.S. Department of Health and Human Services (HHS), through the Assistant Secretary for Health (ASH), issued guidance under the Public Readiness and Emergency Preparedness Act (PREP Act) authorizing qualified pharmacy technicians and State-authorized pharmacy interns to administer childhood vaccines, COVID-19 vaccines when made available, and COVID-19 tests, all subject to several requirements. This guidance clarifies that the pharmacy intern must be authorized by the State or board of pharmacy in the State in which the practical pharmacy internship occurs, but this authorization need not take the form of a license from, or registration with, the State board of pharmacy.

Smart move, CVS.

On Monday, NCQA released the results of its Spring 2020 telehealth questionnaire. Check it out.

On the opioid front, the Wall Street Journal reports today that

Purdue Pharma LP agreed to plead guilty to three felonies related to its marketing and distribution of powerful painkiller OxyContin, as part of an $8.34 billion settlement that caps yearslong federal investigations into tactics the government said helped fuel the opioid crisis.

The Justice Department unveiled the settlement Wednesday, alongside a deal with Purdue’s owners, members of the Sackler family. The price tag for Purdue, however, is largely symbolic: The bankrupt company’s assets fall well short of $8 billion. It will pay the federal government $225 million, and much of the rest of the fines will be waived to allow more money to flow to states, counties and tribes that accuse Purdue of sparking widespread opioid addiction and deaths.

The Sacklers, meanwhile, resolved civil charges for a separate $225 million, but prosecutors made clear criminal investigations into the family continue.

Weekend update

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

Note: The third time is charm. The correct version of OPM’s 2021 Non-Postal Nationwide / FFS Plan Premium chart is now linked to Friday’s note. Thanks readers.

To compensate for this inconvenience, the FEHBlog has attached his treasured actual maximum FEHB government contribution chart 2016-2021. If a plan’s premium is below the maximum government contribution, prescribed by 5 USC Sec. 8906, then plan annual premium increase is covered by the government contribution increase. If, however, the plan’s premium is above the maximum government contribution, the “shield” typically vanishes. As a result, the “above the max” plan’s annual premium changes are quite visible to the member. The maximum government contribution helps tamp down premium increases in this competitive program. The purpose of the chart is to illustrate the fact that the CPI-U is a useful proxy for maximum government contribution changes.

Onto the Weekend Update

The Senate is open for voting and committee work this week. On Thursday morning, the Senate Judiciary Committee will vote on Judge Amy Coney Barrett’s Supreme Court nomination. The House remains on the campaign trail although, according to the Hill, the Speaker has warned the Administration that she will stop negotiating a pre-election COVID-19 relief bill unless a compromise is reached early this week. Turnabout is fair play.

On the COVID-19 vaccine front —

Alex Gorsky, chief executive of Johnson & Johnson, remains upbeat about the possibility of a COVID-19 vaccine arriving as early as this year, despite the health care giant suspending a late-stage clinical trial for one of its own candidates after a patient fell ill this week. “If you just look at the sheer number of compounds that are in development right now, there is a very good probability that late this year or early next year, we will have options for vaccines.”

  • The Department of Health and Human Services announced on Friday that “agreements with CVS and Walgreens to provide and administer COVID-19 vaccines to residents of long-term care facilities (LTCF) nationwide with no out-of-pocket costs.” “The pandemic has inflicted a devastating toll on America’s nursing home residents,” said Centers for Medicare and Medicaid Services Administrator Seema Verma. “That’s why the Trump Administration has taken unprecedented action to protect them in every possible way. This effort will ensure they are at the front of the line for the COVID vaccine and will bring their grueling trial to a close as swiftly as possible.”

On Saturday, according to CNN, the President signed into law a Congressionally approved bill that converts the national suicide hotlines ten digit number 1-800-273-8255 (TALK) to a three digit number 988. The Federal Communications Commission has ordered voice service providers to make the new three digit number available to subscribers by July 16, 2022.

The Centers for Medicare and Medicaid Services released the result of a Medicare beneficiary survey on the impact of COVID-19. It’s a survey of interest to FEHB plans because there is a large cadre of Medicare prime annuitants enrolled in their plans.

21% of Medicare beneficiaries report forgoing non-coronavirus disease 2019 (COVID-19) care due to the pandemic, and nearly all – 98% – of beneficiaries have taken preventative measures to keep themselves safe from the virus.

According to the survey, the most common type of forgone care because of the pandemic was dental care (43%), followed by regular check-up (36%), treatment for ongoing condition (36%), and diagnostic or medical screening test (32%). The most common reason cited for forgoing care was not wanting to risk being at a medical facility (45%).

“An infographic with a snapshot of the survey results is here.  A link to the public use file detailing the survey results is here.”

On the other side of the aging spectrum the Wall Street Journal reports on millennials agreeing to marry in part so that one partner can access the other partner’s employer sponsored health insurance. This has been happening for a long time. What’s interesting to the FEHBlog is that employer sponsored plans, not ACA marketplace plans , are viewed as the life raft.

Friday Stats and More

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

Note to readers — The FEHBlog learned this morning that the 2021 Nationwide / FFS Plan Premium chart did not open properly. The FEHBlog apologizes. Here is the proper link to that report. Now onto 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 41st weeks of this year (beginning May 14 and ending October 15 / five months; using Thursday as the first day of the week in order to facilitate this weekly update):

As you can see there has been uptick in cases over the last month or so.

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

The hospitalization rate has been fairly steady for the past two months.

Because the new deaths line in the chart above is flat because new cases greatly exceed new deaths, here is a chart of new COVID-19 deaths over the same period (May 14 through October 14 (five months).

COVID-19 weekly deaths also have plateaued around 4,000 over the past month. The CDC advises in this week’s COVID-19 surveillance report that

Nationally, weekly COVID-19-associated hospitalization rates reported through COVID-NET have remained steady for all age groups in recent weeks; however, rates have increased in 7 of 14 COVID-NET sites during this time period. Based on death certificate data, the percentage of deaths attributed to pneumonia, influenza, or COVID-19 (PIC) for week 41 was 7.2% and, while declining, remains above the epidemic threshold. Hospitalization and mortality data for the most recent weeks may change as additional data are reported.

Meanwhile the CDC’s last flu surveillance report states simply that “Seasonal influenza activity in the United States remains low.”

The Wall Street Journal reports that Pfizer “Chief Executive Albert Bourla said Friday the company could start to see from a large study whether the [COVID-19] vaccine works by the end of this month and would have data on its safety by the third week of November. If the preliminary results indicate the vaccine can work safely, Pfizer could ask U.S. health regulators to permit use by late November, Mr. Bourla said.” That’s encouraging.

Govexec informs us that “The Trump administration has put together a set of recommendations that agencies throughout government can use when bringing employees back to their offices, contracting with a private sector firm to compile the suggestions.”

Following up on yesterday’s report on the plans that are displaying their 2021 benefit and premium changes on their websites — you can add GEHA to that growing list. Blue Cross FEP also added to its website an explanation of how it plans to conduct a virtual Open Season in 2020.

Happy New Fiscal Year

David Ermer–COVID-19, COVID-19 testing, COVID-19 vaccine, Federal employment benefits, HIPAA Privacy and Security Rules, OPM–

Today, October 1, 2020, is the beginning of the new 2021 federal fiscal year and the fourth calendar quarter of 2020. Federal News Network reports that the President signed the compromise continuing resolution into law at 1 am this morning. The federal government is now funded through December 11, 2020.

The Washington Post reminds us that

Most federal employees [became] eligible Thursday [October 1] for paid parental leave, a benefit valued at about $1 billion a year and one of the most significant expansions of their benefits since the creation of unpaid parental leave more than 25 years ago. The new entitlement will allow employees to take paid time off for part or all of 12 weeks over a 12-month period, effective with births, adoptions or foster placements that occur Thursday and after. Previously, employees could take 12 weeks of unpaid time available under the Family and Medical Leave Act.

On the COVID-19 front —

  • The Wall Street Journal provides operational background on the current Phase III COVID-19 vaccine trials.
  • The Department of Health and Human Services announced an agreement with the Rockefeller Foundation “to identify and share effective approaches for using rapid point-of-care (POC) antigen tests to screen for COVID-19 in communities, with a focus on safely reopening K-12 schools. The partnership establishes a pilot program with select cities and states in The Rockefeller Foundation’s Testing Solutions Group (TSG), a network of public officials devoted to rapidly scaling COVID-19 testing, tracing, and tracking in their communities.”
  • STAT News discusses the somber connection between diabetes and COVID-19.

Data from the U.S. Centers for Disease Control and Prevention show more than three-quarters of people who died from Covid-19 had at least one preexisting condition. Overall, diabetes was noted as an underlying condition for approximately 4 in 10 patients. Among people younger than 65 who died from the infection, about half had diabetes.

[Moreover,] Juliana Chan, director of the Hong Kong Institute of Diabetes and Obesity, said the pandemic has intertwined with and exposed two other widespread problems: diabetes and disparities triggered by social determinants of health.

“What we are seeing is nothing new, but it is really just on a massive and global scale,” she said in an interview. “I hope that there is something positive out of this, that people understand that we are hit by three epidemics.”

  • The U.S. Department of Labor issued additional FAQs “regarding the need to report employees’ in-patient hospitalizations and fatalities resulting from work-related cases of the coronavirus.”

Because October is National Cybersecurity Awareness Month, the FEHBlog wishes to point out this Health IT Security report that

From October 2019 to July 2020, Microsoft data shows hackers have rapidly improved the sophistication and increased the frequency of cyberattacks. And when it comes to incident response engagements, ransomware attacks were the most common cause. The report follows reports that the Universal Health Services health system is currently recovering from what appears to be one of the biggest ransomware attacks in recent history. Further, nearly a dozen healthcare entities in the past month have either faced similar incidents or saw their data leaked online by ransomware threat actors.