Midweek update

COVID-19 testing

Midweek update

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

Govexec reports that

The House on Wednesday [December 9] passed a stopgap funding bill 343-67 that would give lawmakers an additional week to come up with full-year spending legislation and avoid a government shutdown later this month.  The continuing resolution would last for one week, setting a new funding deadline of Dec. 18. The Senate must still pass the CR and President Trump must sign it by Friday to avoid a government shutdown, which both are expected to do. 

The Wall Street Journal adds that “A flurry of competing proposals for another coronavirus relief package ricocheted around the Capitol Wednesday, as lawmakers hunted for ways to resolve a thorny debate over liability protections that has stymied progress for weeks.” A December 9 fact sheet on the bipartisan proposal was made available today. Check it out.

In Presidential transition news, President-elect Biden announced the following additional healthcare appointments earlier this week:

  • Vivek Murthy, M.D., for a second tour of duty as surgeon general
  • Rochelle Walensky, MD, Harvard professor, as CDC director
  • Marcella Nunez-Smith, MD, Yale Professor, as COVID-19 Equity Task Force Chair
  • Jeff Zients, Deputy OMB Director for Management in Obama Administration, as Covid-19 czar.
  • Anthony Fauci, MD, as Coordinator of COVID-19 response and Counselor to the President
  • Sidebar — Still waiting for FDA Commissioner appointment
  • Added Cathie McQuiston, AFGE Deputy GC, to the OPM review team

Tomorrow December 10 is the date set for the FDA Vaccines and Related Biological Products Advisory Committee virtual meeting on the Pfizer-BioNTech emergency use authorization application for its COVID-19 vaccine. The CDC’s Advisory Committee on Immunization Practices will meet on Friday December 11 and vote on Sunday December 13 per Reuters. “

Dr. William Schaffner, an infectious disease expert and non-voting member of the CDC’s ACIP, said the gap between the two ACIP meetings will allow the FDA time to draft and issue an emergency use authorization (EUA) before the ACIP vote. That schedule could change, however, if FDA advisers have questions or request more data [tomorrow], he said.

Today the FDA announced that it has

authorized LabCorp’s Pixel COVID-19 Test Home Collection Kit for use by any individual 18 years and older without a prescription. This product, which is authorized as the first COVID-19 direct-to-consumer (non-prescription) test system, allows an individual to self-collect a nasal swab sample at home and then send that sample for testing to LabCorp. Positive or invalid test results are then delivered to the user by phone call from a health care provider. Negative test results are delivered via email or online portal.

This home sample collection kit can be purchased online or in a store without a prescription. It is intended to enable users to access information about their COVID-19 infection status that could aid with determining if self-isolation (quarantine) is appropriate and to assist with health care decisions after discussion with a health care professional.

“This is the first kit for consumers to self-collect a nasal sample for COVID-19 in their home that does not require a prescription,” said Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health. “While many home collection kits can be prescribed with a simple online questionnaire, this newly authorized direct-to-consumer collection kit removes that step from the process, allowing anyone to collect their sample and send it to the lab for processing.”

Most excellent.

Health Payer Intelligence reports that

Blue Cross and Blue Shield is calling on payers to bolster vaccination rates by expanding access to care, connecting with members through digital platforms, hosting free flu vaccine clinics, and utilizing data to target support for at-risk communities The effort comes in response to a drastic decrease in the number of vaccinations this year, compared with 2019 data.

Monday Roundup

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

Happy National Rural Health Day

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

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

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

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

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

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

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

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

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

Also HHS announced today launching

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

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

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

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

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

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

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

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

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

In other news —

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

Midweek update

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

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

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

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

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

Moreover, medical device manufacturer Lucira Health announced today that

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

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

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

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

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.

Monday Roundup

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

In COVID-19 vaccine news —

  • The American Hospital Association has a COVID-19 vaccine resources and information website.
  • PharmaManufacturing is reporting that ” Pfizer’s CEO recently stated that the company could be ready to submit data from a late-stage trial of its coronavirus vaccine by the end of October — but experts are urging the company to slow its roll. According to Bloomberg Law, more than 60 bioethicists and researchers have penned a letter asking Pfizer to delay data reporting until November.” Why not let the Food and Drug Administration do its job?

In COVID-19 rapid testing news, HHS announced today a detailed “national distribution plan for the Abbott BinaxNOW Ag Card rapid test to assist Governors’ efforts to continue to safely reopen their states. BinaxNOW is a unique testing option to provide support to K-12 teachers and students, higher education, critical infrastructure, first responders, and other priorities as governors deem fit. The BinaxNOW rapid test – the only U.S. Food and Drug Administration-authorized antigen rapid point-of-care test that does not require an instrument – is easy to use, will produce COVID-19 test results in 15 minutes, and costs $5. * * * The Federal government purchased these Abbott BinaxNOW diagnostic tests on August 27, 2020, to ensure equitable distribution of the first 150 million units – one day after an Emergency Use Authorization (EUA) was issued by the FDA to ensure they would be expeditiously distributed to vulnerable populations as quickly as possible.

In other news —

  • The Centers for Disease Control reported today about COVID-19 trends among school age children in our country. “Since March, 277,285 COVID-19 cases in children have been reported [out of seven million in total]. COVID-19 incidence among adolescents aged 12–17 years was approximately twice that in children aged 5–11 years.”
  • Healio reports on the multiple uses of telehealth beyond acute primary care. “[T]elehealth has been routinely incorporated in specialties such as psychiatry and asthma/allergy care, even prior to the COVID-19 era [‘PC”]. * * * Further, telemedicine allows for triage of patients with COVID-19 symptoms without requiring face-to-face visits to help direct next steps for testing and treatment. Telehealth can be effectively incorporated into oncology care — provided thoughtful and appropriate measures are taken.”
  • There has been a lot of press about the nomination of Judge Amy Coney Barrett to the Supreme Court following the sad occasion of Justice Ruth Bader Ginsburg’s death. It is quite likely that Judge Barrett will be sitting on the Supreme Court when the California v. Texas case is argued on November 10. Speculation is rife about this development and it is truly unfortunate that the Trump Administration is now siding with the States opposing the law’s constitutionality in the California v. Texas case. In the FEHBlog’s opinion, the position against the law’s constitutionality is a weak cup of tea. The FEHBlog is confident that the Supreme Court opted to hear the case to end this litigation in favor of the ACA’s general constitutionality. Congress obviously did not intend to render the ACA unconstitutional by zeroing out the individual mandate. The American Prospect observes

The whole legal argument [against the ACA’s constitutionality] depends on the fact that Republicans used reconciliation to pass the 2017 tax bill through the Senate with a simple majority. Due to the restrictions around reconciliation, Republicans couldn’t technically repeal the mandate in total, instead just lowering the penalty to nothing. The case effectively goes away if Congress either adds back in a penalty (even of just one cent), or just officially repeals the mandate, thereby severing it from the whole health care law.

Trying to bring back a penalty is a terrible option. The mandate is deeply unpopular, and it would be easy for Senate Republicans to oppose that move. What’s more, in the months since the mandate penalty went away, we’ve learned that it wasn’t as necessary to making the Obamacare system work as Democrats insisted in 2009 and 2010. Fully repealing the individual mandate, on the other hand, is an easy fight to win, as well as good policy. It is generally bad to have unenforced laws on the books.

Congress should take this action now by enacting an individual mandate repeal just as it repealed other ACA taxes in 2019. This is not to suggest that Congressional action is the only step that could save the law. But it would short circuit this craziness.

Weekend Update

David Ermer–Congress, COVID-19, COVID-19 testing, Electronic health records, OPM, U.S. Healthcare–

The FEHBlog is back inside the Beltway after a relaxing week on the Jersey Shore.

Both Houses of Congress will be conducting legislative and committee work this week following Yom Kippur which occurs from sundown tonight until sundown tomorrow. The Senate must pass the compromise continuing resolution funding the federal government through December 11 no later than Wednesday September 30.

On September 30, the Senate Homeland Security and Governmental Affairs Committee will take up the nomination of Chad Wolf to be Secretary of Homeland Security. The Committee continues to defer action of the nomination of John Gibbs to be OPM Director.

Before long OPM will be publicizing the 2021 FEHBP government contribution. The September 1, 2020, OPM Benefit Administration Letter states that OPM will be taking this action in “early October” and early October starts this Thursday October 1. Thanks to Google Alerts, the FEHBlog ran across this Janesville (Wisc.) Gazette article reporting that an FEHB plan called MercyCare with only 80 enrollees understandably will be leaving the FEHB Program at the end of this year.

While driving back from New Jersey the FEHBlog was musing about the uptick in COVID-19 cases. This musing reminded him to provide a link to this lengthy Wall Street Journal article published earlier this month about the “really diabolical” COVID-19 virus. WSJ articles on COVID-19 usually are accessible outside the paper’s paywall.

Taken on its own terms, SARS-CoV-2 is the infectious disease success of the past 100 years.

Almost unmatched in the annals of emerging human contagions, it has parlayed a few chance infections into a pandemic of around 27 million confirmed cases so far.

Doctors long expected the advent of such a virus, but even so, the shrewdness of the coronavirus caught many by surprise, and goes a long way to explaining how the world has struggled to contain it ever since.

“We underestimated it,” said Peter Piot , the head of the London School of Hygiene & Tropical Medicine and a co-discoverer of Ebola, who fell victim to the coronavirus himself in March.

In any event, looking forward, Healthline offers an update on the state of rapid COVID-19 testing.

In other news

  • Fierce Healthcare reports on UnitedHealthcare’s vision for a path forward on health reform. The study highlights the following policy priorities: 1. Universal coverage, 2. Improving affordability, 3. Enhancing the health experience, and 4. Boosting health outcomes.
  • Fierce Healthcare also provides insights into last week’s final rule creating a process for importing less expensive drugs from Canada. “HHS didn’t comment on whether Canada was on board with any re-importation proposals. The country has vociferously opposed national re-importation measures because of concerns it would dwindle their own drug supplies.” Time will tell. The FEHBlog is not a fan of this sort of drug importation.
  • Healthcare Dive reports that “Microsoft’s video platform, Teams, is integrating directly with electronic health records software to permit clinicians to launch telehealth visits from the EHR.” Microsoft’s first integration deal is with the largest EHR vendor Epic. This will facilitate direct telehealth visits between primary care providers and the patients.
  • Health Payer Intelligence discusses payer strategies for offering home healthcare / remote monitoring to members.

Midweek Update

David Ermer–Congress, COVID-19 testing, COVID-19 vaccine, HIPAA Privacy and Security Rules, Rx coverage–
Photo by Manasvita S on Unsplash

Roll Call informs us that the House of Representatives pass the compromise Fiscal Year 2021 continuing resolution (H.R. 8337) by a wide margin. The bill heads onto the Senate which is expected also to pass the bill before the end of the current fiscal year next Wednesday September 30.

In COVID-19 news —

Johnson & Johnson (J&J) has begun a 60,000-subject phase 3 assessment of its COVID-19 vaccine. The trial will enroll participants in the U.S. and other countries with a high incidence of COVID-19 with a view to generating data to support emergency use authorization early next year. * * * Unlike its rivals, J&J is evaluating the safety and efficacy of a single dose of a COVID-19 vaccine. If the one-dose regimen is successful, J&J could eliminate the logistical complexity and dropouts associated with trying to get people to return for a second shot. A one-shot regimen would also enable J&J to vaccinate 1 billion people each year. Few manufacturers of two-dose regimens can match that figure. * * *

In disclosing the start of the phase 3, J&J also called out the storage requirements of its vaccine. The candidate is expected to be stable for two years at -20°C and for upward of three months in the 2°C to 8°C range used to store many biologics. J&J said the candidate is “compatible with standard vaccine distribution channels and would not require new infrastructure to get it to the people who need it.” Pfizer’s mRNA vaccine must be kept at -70⁰C and be used within 24 hours of being thawed. Other COVID-19 vaccines have storage requirements more comparable to those of J&J’s shot.

Good news.

  • Fierce Healthcare reports that Walmart plans to use drones to deliver self-administered COVID-19 tests to single family homes within a one miles radius of one of their “pilot” stores. The recipient will need to mail the nasal sample to a lab. The gold standard will be self administered tests that can read out at home like a pregnancy test, but they are getting closer.

Fierce Healthcare also calls our attention to the fact that Optum’s latest quarterly drug pipeline report explains how health plans can prepare to cover “chimeric antigen receptor T-cell (CAR-T) therapies coming to market. CAR-T treatments for cancer are costly but are proliferating as they offer a potentially curative treatment for the disease. Through CAR-T therapy, a patient’s cells are modified in a lab and then reintroduced to the body to attack the cancer.”

The Health and Human Services Office for Civil Rights, which enforces the HIPAA Privacy and Security Rules, took another HIPAA business associate scalp today.

CHSPSC LLC, (“CHSPSC”) has agreed to pay $2,300,000 to the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) and to adopt a corrective action plan to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules related to a breach affecting over six million people. CHSPSC provides a variety of business associate services, including IT and health information management, to hospitals and physician clinics indirectly owned by Community Health Systems, Inc., in Franklin, Tennessee.

Thursday Miscellany

David Ermer–CDC, Congress, COVID-19, COVID-19 testing, COVID-19 vaccine, U.S. Healthcare–
Photo by Juliane Liebermann on Unsplash

The FEHBlog heard on a webinar today that the House of Representatives will be releasing their FY 2021 continuing resolution tomorrow. That resolution according to press reports will be acceptable to the Senate and the White House. The FEHBlog will keep an eye out.

In COVID-19 news

  • Fierce Pharma reports that “Moderna reached human testing for its COVID-19 vaccine candidate in record time, and now with its phase 3 trial moving right along, the company is expecting efficacy data in November—likely after Pfizer and BioNTech, but before everyone else.”
  • Fierce Healthcare reports that “CVS Health is planning to double the number of its drive-thru testing sites by mid-October, the healthcare giant announced on Thursday [September 17]. CVS intends to add more than 2,000 sites at its pharmacies in the next several weeks, bringing its total to more than 4,000 nationwide. The new locations will be opened in waves, beginning with 400 new sites opening on Friday. CVS currently offers testing in 33 states and the District of Columbia.”
  • Medscape reports that “Eli Lilly and Co said on Wednesday interim trial data showed its experimental monoclonal antibody treatment reduced the need for hospitalization and emergency room visits for patients with moderate COVID-19. The company said it will discuss the interim results, which have not yet been reviewed by outside experts, with global regulators. A Lilly spokeswoman said discussions with the U.S. Food and Drug Administration are expected to range from additional clinical trials to the possibility of an emergency use authorization.”

Progress. Also a Centers for Disease Control study has confirmed an earlier Wall Street Journal report that widespread flu immunization plus continued use of social measures to prevent the spread of COVID-19 , e.g., social distancing, mask wearing, etc, should lead to an easy flu season in the United States this winter.

In other news, Healthcare Dive provides health insurer CEO insights on 2021. “Though there’s significant uncertainty around the future of the insurance industry, many remarks can be summed up in a line from Cigna CEO David Cordani: ‘We feel bullish on 2021.’ And despite the major role of government in regulating healthcare, most officials seemed agnostic on the presidential election looming in less than two months.” That is certainly encouraging.

Monday Roundup

David Ermer–Congress, COVID-19, COVID-19 testing, COVID-19 vaccine, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

Becker’s Health IT offers 20 bold health IT predictions for the next five years. Here are the FEHBlog’s favorites:

1. Joel Klein, MD. Senior Vice President and CIO of University of Maryland Medical System (Baltimore): I think at least half of all healthcare in America will be virtual within five years. There are two barriers:

• Payers. They might pay less but if they pay enough, it will be enough. If we can figure out how to solve emergency department visits with widespread, cost effective on-demand care, that will make a difference.
• ‘But I want to see my doctor.’ That might be true for some things, but the convenience factor (especially for tertiary care… especially for millennials…) once you really start doing it overwhelms most of the physical presence upsides.

Edward Lee, MD. CIO of The Permanente Federation (Oakland, Calif.): In five years, physicians will no longer need to manually document their notes into the EHR. Instead, artificial intelligence will capture all the pertinent information from the patient-physician encounter. This will enable physicians to spend quality time with their patients instead of worrying about writing their notes or placing orders in a computer system. Joy and meaning for physicians will increase, physician burnout will decrease, and above all, patient care will improve.

Michael Pfeffer, MD. Assistant Vice Chancellor and CIO of UCLA Health: Health IT will enable each patient to have a unified, interactive view of their health information regardless of place of care or type of clinical data (i.e. phenotypic, genomic, imaging). AI-based apps will help make sense of their data, taking into account social determinants of health and potential health disparities to improve health equity and health literacy. This intelligence will be paired with personal health preferences and data on health provider quality, access, pricing and satisfaction to help patients make truly informed decisions about their care.

Fierce Biotech reports that “Just under a week after it stopped its key phase 3 pandemic vaccine test [due to a safety concern], AstraZeneca and the University of Oxford have been given the green light to restart in the U.K.” What’s more

While AZ and Oxford have been highlighted as [COVID-19 vaccine] race leaders, so too have Pfizer and BioNTech, which said they now want to boost their phase 2/3 trial for one of their five mRNA vaccines, BNT162b2, from around 30,000 to 44,000.

Also over the weekend, the companies said they have asked the FDA for the extra participants in order to include a broader patient population and with plans to include adolescents as young as 16 and people with chronic, stable HIV (human immunodeficiency viruses), hepatitis C or hepatitis B infection to “provide additional safety and efficacy data.”

It said it’s on track to hit its original target of 30,000 patients this week; despite wanting more people, Pfizer said in a statement that it was still on course to deliver data by the end of next month.

CVS Health announced last week that in response to demand created by children returning to school, it has made “children age 12 years and older eligible for testing at the more than 2,000 test sites located at select CVS Pharmacy drive-thru testing locations, starting last Friday, September 11.”

In other news

  • The Washington Post reports that commuting in the Washington DC metropolitan area may not be back to normal until next summer.

Some 430 employers representing about 275,000 workers in the greater-Washington region — stretching from Baltimore to Richmond — participated in the survey conducted Aug. 10 to 28. Their responses offer a snapshot of what companies are thinking as they weigh resuming in-office operations.
A clear majority of Washington-area employers said they are adopting a phased approach to returning to the office, although many said they remain uncertain about the timing of that return. A third of the region’s employers said they don’t know whether they will have their workers back on site by next summer.

  • Govexec.com reports that “The Office of Personnel Management issued a proposed rule [today] that would enable federal agencies to appoint employees in STEM jobs, or positions on temporary or new projects or organizations, for a decade. OPM said the change would give agencies more flexibility when tackling long-term science, technology, engineering and mathematics projects and other non-permanent work. Current regulations require agencies to get special permission from OPM to keep any term employee on staff for longer than four years.” The public comment deadline is November 10, 2020.
  • The House Oversight and Reform subcommittee on government operations held a postal update hearing today. It turns out that the subcommittee’s objective was to be to call the Postmaster General’s qualifications into question. A bipartisan Postal Service Board of Governors selects the Postmaster General, rather than following the usual Presidential appointment followed by Senate confirmation route.