Thursday Miscellany

Thursday Miscellany

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The Wall Street Journal reports today that the Blue Cross Blue Shield Association (BCBSA) has reached with class plaintiffs’ counsel a tentative settlement agreement in a employer and individual consumer class action alleging anti-trust law violations among Blue Cross licensees that was filed in 2012. The settlement which includes $2.7 billion in payments and BCBSA operational changes intended to increase competition among Blue Cross licensees. The agreement is pending approval by the Blue Cross licensees and an Alabama federal court judge.

BCBSA also is facing a similar class action brought by a class of healthcare providers. The Journal report indicates that this case is headed to litigation. If you can’t access the Journal article due to its paywall (which is worth the investment in the FEHBlog’s humble opinion), Becker’s Hospital Review summarizes the settlement here.

Somewhat ironically, according to this Health Payer Intelligence report, the House of Representatives earlier this week passed a bill to repeal a law passed in 1945 that exempts health insurers from certain federal anti-competitive regulations.

The President issued an executive order today discussing his healthcare strategy and warning Congress that Health and Human Services will act to end healthcare surprise billing if Congress fails to pass its own surprise billing law by the end of the year. HHS issued a press release about the following agency actions taken today to implement the President’s strategy:

  • Issued a final rule from the Food and Drug Administration to open the first-ever pathway for states to use to safely import prescription drugs to lower patients drug costs.
  • Solicited private-sector proposals, as called for in the President’s July executive order, on allowing Americans to get lower-cost FDA-approved drugs and insulins from American pharmacies via importation and reimportation.
  • Released the 2021 Medicare Advantage and Medicare Part D Premium landscape, showing that average 2021 premiums for Medicare Advantage plans are expected to decline 34.2 percent from 2017 while plan choice, benefits, and enrollment continue to increase, and that Part D premiums will be down 12 percent from 2017, with over 1,600 drug plans offering insulin at no more than $35 per month.
  • Issued a notice of proposed rulemaking from the Health Resources and Services Administration to pass on steep discounts at community health centers on insulin and epinephrine to Americans who are uninsured or have high cost-sharing, including the nearly 3 million health center patients with diabetes.

The Society for Human Resource Management compares the Presidential candidate’s health plan coverage proposals here.

Last month the FEHBlog noted that GoodRx, the prescription drug discounter, was planning an initial public offering. Fierce Healthcare reports that

GoodRx raised $1.1 billion in its initial public offering after pricing its deal well above its expected price range. The GoodRx IPO began trading Wednesday at $46 per share, 39% above its $33 per share offering price. GoodRx stock rose above $49 per share in early afternoon action, Investors.com reported. That boosted the consumer healthcare technology firm’s market cap to about $12.7 billion.

Whoa Nelly.

Midweek Update

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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.

Monday Roundup

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The House of Representatives Rules Committee issued a rule today on the FY 2021 continuing resolution (H.R. 8913) by a 7-3 vote. The House is expected to vote on the bill soon. Nothing is certain in this world but the FEHBlog considers this CR to be on track to become law.

Katie Keith writes in the Health Affairs Blog on the impact of Justice Ruth Bader Ginsburg’s death on the California v. Texas case (No. 19-840) raising the constitutionality of the Affordable Care Act (“ACA”) That case is scheduled for oral argument on November 10 one week after the national election. The FEHBlog expects the Supreme Court to preserve the ACA no matter who wins the Presidential election because the Texas case challenging the law is weak. The proof is in the pudding as the preexisting condition free ACA marketplace has kept running without the individual mandate, just like the FEHBP.

The Centers for Disease Control last week issued its 2019 U.S. maps of adult obesity prevalence. Here are the CDC’s obesity tidbits which should be useful for FEHB plans which cover the nation in particular:

  • 6 states had an obesity prevalence of 35 percent or higher among non-Hispanic White adults.
  • 15 states had an obesity prevalence of 35 percent or higher among Hispanic adults.
  • 34 states and the District of Columbia had an obesity prevalence of 35 percent or higher among non-Hispanic Black adults.
  • Obesity decreased by level of education. Adults without a high school degree or equivalent had the highest self-reported obesity (36.2%), followed by high school graduates (34.3%), adults with some college (32.8%) and college graduates (25.0%).
  • Young adults were half as likely to have obesity as middle-aged adults. Adults aged 18-24 years had the lowest self-reported obesity (18.9%) compared to adults aged 45-54 years who had the highest prevalence (37.6%).
  • All states and territories had more than 20% of adults with obesity.
  • 20% to less than 25% of adults had obesity in 1 state (Colorado) and the District of Columbia.
  • 25% to less than 30% of adults had obesity in 13 states.
  • 30% to less than 35% of adults had obesity in 23 states, Guam, and Puerto Rico.
  • 35% or more adults had obesity in 12 states (Alabama, Arkansas, Indiana, Kansas, Kentucky, Louisiana, Michigan, Mississippi, Oklahoma, South Carolina, Tennessee, and West Virginia).
  • The Midwest (33.9%) and South (33.3%) had the highest prevalence of obesity, followed by the Northeast (29.0%), and the West (27.4%).

The Health and Human Services Office for Civil Rights announced today that the “Athens [Georgia] Orthopedic Clinic PA (“Athens Orthopedic”) has agreed to pay $1,500,000 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 HIPAA Privacy and Security Rules.” Athens Orthopedic which serves 138,000 patients annually settled allegations of widespread system violations of those rules.

Weekend update

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Greetings from North Beach, NJ. The FEHBlog will be writing from outside the Beltway for the coming week.

Both Houses of Congress are is session for committee and legislative business this coming week. The House Rules Committee will consider the FY 2021 continuing resolution tomorrow.

The FEHBlog noticed that last week the President nominated OPM’s Acting / Deputy Director Michael Rigas to fill permanently fill his other and more important acting position, Deputy Director for Management at the Office of Management and Budget. It’s too bad that Mr. Rigas was not nominated for OPM Director back in 2017. He certainly has impressed people in the Trump Administration.

The Federal News Network reports that

“Due to the ongoing management challenges that the COVID-19 pandemic presents for our workforce, the Government Managers Coalition believes the federal government would benefit from the establishment of a [permanent] emergency leave transfer program (ELTP) both as a management tool and as a means by which to support our workforce,” the organizations said in a recent letter to Michael Rigas, acting director of the Office of Personnel Management. “An ELTP would be a novel solution, especially for employees with caregiving responsibilities affected by school and daycare closures.” Under an emergency leave transfer program, federal employees can donate unused annual leave to their colleagues who are adversely impacted by a major disaster. Employees who are impacted by a national emergency can apply in writing to become recipients of the donated leave.

This is a good idea for other large and even mid-sized employers.

In other news

  • The Wall Street Journal reports that

When enough people become immune such that the whole community is protected, it’s called herd immunity. Herd immunity can sometimes occur naturally from survivors of the disease within a population, but often not without many deaths. Covid-19 has so far killed close to 200,000 people in the U.S. Epidemiologists believe only a small percentage of the nation has been infected and developed some level of immunity. The introduction of a vaccine can be the quickest, safest way of creating herd immunity, since people can develop immunity without getting the disease.

According to the Great Influenza, the world’s population eventually achieved herd immunity from the 1918 influenza, by a mild first wave of the virus and millions upon millions of deaths from the second wave. Of course, there was no vaccine for the great influenza one hundred years ago.

  • Healthcare Dive informs us that “One year after the first Walmart Health location opened in Dallas, Georgia, the retail giant is moving forward with nationwide expansion of its health superstores.” The FEHBlog is intrigued by Walmart’s healthcare actions.
  • Last week, the Centers for Medicare and Medicaid Services announced that “it has finalized the End-Stage Renal Disease (ESRD) Treatment Choices (ETC) Model (fact sheet), to improve or maintain the quality of care and reduce Medicare expenditures for patients with chronic kidney disease. The ETC Model delivers on President Trump’s Advancing Kidney Health Executive Order and encourages an increased use of home dialysis and kidney transplants to help improve the quality of life of Medicare beneficiaries with ESRD. The ETC Model will impact approximately 30 percent of kidney care providers and will be implemented on January 1, 2021 at an estimated savings of $23 million over five and a half years.”

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 37th weeks of this year (beginning May 14 and ending September 16; 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:

Because the FEHBlog does look at his charts which are intended to show trends, he realized that new deaths chart is flat because new cases greatly exceed new deaths. Accordingly here is a chart of new COVID-19 deaths over the same period (May 14 through September 16 (basically four months).

In other COVID-19 news:

  • The Wall Street Journal reports

U.S. hospitals expect to be better prepared if a second wave of Covid-19 cases hits in coming months, doctors and administrators say, after gaining a better understanding how to triage patients, which drugs to use and what supplies are needed. When the new coronavirus first struck, beds filled up at record speed, ventilators were in short supply and proven treatments were scant. Since then, doctors say, they have developed a better understanding of who needs a ventilator and how quickly a patient can be discharged, and studies have pointed to a few drugs like the antiviral remdesivir and the steroid dexamethasone that can help

The FEHBlog heartily agrees that the country is better prepared but he believes that the Journal is assuming facts not in evidence when it speaks about a second wave because we really are still in the first wave.

  • Medscape offers an MD’s perspective on the leading COVID-19 vaccine candidates.
  • The Wall Street Journal reports that the Centers for Disease Control withdrew last month’s highly criticized advice that people who had contact with asymptomatic COVID-19 patients don’t need a COVID-19 test. “The Sept. 18 updated recommendation now says that close contacts of a person with a confirmed Covid-19 infection need a test even in the absence of symptoms. The changes were described as a clarification, rather than a revision, on the CDC website.”
  • Speaking of COVID-19 testing, Mercer Consulting offers advice on how to cover COVID-19 testing which Congress made unnecessarily complicated.

In other news,

  • Govexec.com reports that “House Democrats are preparing to vote [next week] on a six-week stopgap spending bill that would keep agencies open through Dec. 11, according to Democratic aide.” From reading the article, it looks like the continuing resolution which is not fully backed will be enacted thereby avoiding what would be the craziest government shutdown in American history.
  • Speaking of criticism, Fierce Healthcare reports that “the American Academy of Family Physicians, which represents about 135,000 physicians, said the recommendations miss the mark and skew toward virtual-only telehealth vendors and large medical systems with established telehealth infrastructure. The task force’s report doesn’t address the needs of independent practices that need guidance, support and payment advocacy, wrote Stephanie Quinn, AAFP senior vice president of advocacy, practice advancement and policy in a blog post Tuesday.” The most encouraging tele heath acceleration that the FEHBlog witnessed during the great hunker down is patients holding telehealth visits with their own doctors. That FEHBlog agrees with AAFP that this trend that should be strongly encouraged.
  • Healthcare Dive reports that “Privately insured patients pay 247% more at hospitals on average than Medicare patients for the same care, according to a new study by nonprofit think tank RAND. The study, based on 2018 data, shows the gap is increasing from 2017 and 2016, which saw disparities of 230% and 224%, respectively. If private payers had paid Medicare rates over the three-year study period, they would have saved $19.7 billion, RAND determined. The study could provide fodder for proponents of a government-run public option, a key tenet of Democratic presidential nominee Joe Biden’s healthcare agenda, which — like Medicare — would negotiate prices with hospitals and other providers.

Hey, Healthcare Dive, in contrast to health plans which do negotiate with healthcare providers Medicare imposes prices on providers. Government price fixing leads to disparities like this and it’s far from a good thing.

Thursday Miscellany

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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.

Midweek update

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The Federal Times and Govexec.com report that the Senate Homeland Security and Governmental Affairs Committee postponed voting this morning on John Gibbs’ nomination to be Office of Personnel Management Director. Federal employee organizations have publicly opposed his nomination.

It occurs to the FEHBlog that OPM has not had a long acting director since Ambassador John Berry who served in that role for President Obama’s entire first term. Before Mr. Berry the OPM Directors usually lasted one Presidential term. So for the past eight years OPM has mirrored the Washington Football Team’s approach to head coaches and quarterbacks.

Healthcare Dive reports that

Cigna is rebranding its growing health services segment, including pharmacy benefit manager Express Scripts, as Evernorth, the Connecticut-based payer announced Wednesday. The new umbrella brand will encompass Express Scripts, specialty pharmacy Accredo, medical benefit manager Evicore and Cigna’s other health service product lines starting in the third quarter. The rebranding, which has been in the works for months pre-pandemic, is the next evolution of the Cigna-Express Scripts tie-up completed in late 2018, as the combined entity looks to spur more interest in its products from third parties in the industry.

The late U.S. Navy Admiral and Arctic explorer Robert Peary would be pleased.

Healthcare Dive also reports that

  • “CVS Health has struck a deal with Apple to give temporary free access for the health giant’s clients, customers and employees to Apple’s new subscription fitness service.
  • Beneficiaries enrolled in Aetna’s commercial or CVS Caremark’s prescription plans will be offered a free one-year subscription to the feature, called Apple Fitness+. A free two-month subscription will be offered to CVS Pharmacy ExtraCare members and all CVS employees after the service is launched, per Tuesday {September 15]’s release.
  • The announcement coincided with Apple’s unveiling of the subscription service, which offers virtual fitness classes. The tech giant on Tuesday also released the latest model of its Apple Watch, which includes a new blood oxygen level tracker.”

The National Committee for Quality Assurance released yesterday the final report of its Task Force on Telehealth. Here are the task force’s recommendations:

Policymakers should make permanent the following specific COVID-19 policy changes:

Lifting geographic restrictions and limitations on originating sites. Allowing telehealth for various types of clinicians and conditions. Acknowledging, as many states now do, that telehealth visits can meet requirements for establishing a clinician/patient relationship if the encounter meets appropriate care standards or unless careful analysis demonstrates that, in specific situations, a previous in-person relationship is necessary. Eliminating unnecessary restrictions on telehealth across state lines.

Policymakers should look closely at the effect of expanding prescribing authority to telehealth, as authorized by the PHE. They should evaluate what policies and guidelines could be applied to virtual prescribing to ensure patient safety and avoid adverse outcomes.

Policymakers should fully reinstate enforcement of Health Insurance Portability and Accountability Act (HIPAA) patient privacy protections that was suspended at the start of the public health emergency.

The Department of Health and Human Services and the Defense Department announced their COVID-19 vaccine distribution strategy today.

The strategic overview lays out four tasks necessary for the COVID-19 vaccine program:

  • Engage with state, tribal, territorial, and local partners, other stakeholders, and the public to communicate public health information around the vaccine and promote vaccine confidence and uptake.
  • Distribute vaccines immediately upon granting of Emergency Use Authorization/ Biologics License Application, using a transparently developed, phased allocation methodology and CDC has made vaccine recommendations.
  • Ensure safe administration of the vaccine and availability of administration supplies.
  • Monitor necessary data from the vaccination program through an information technology (IT) system capable of supporting and tracking distribution, administration, and other necessary data.

Federal News Network helpfully has created an online payroll deferral calculator for this federal employees and military members who are subject to this COVID-19 relief action.

Tuesday Tidbits

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The Hill reports on the House leadership’s strategy for the COVID-19 relief bill.

Speaker Nancy Pelosi (D-Calif.) on Tuesday sought to heighten the pressure on Republicans to move a new round of coronavirus relief, announcing that the House will return to the Capitol next month to vote on another aid package if a bipartisan agreement is struck before the elections. * * *

House Majority Leader Steny Hoyer (D-Md.) acknowledged that most lawmakers will likely return to their districts when the scheduled session ends on Oct. 2, leaving party leaders seeking to hash out an agreement with the White House. If such a deal emerges, then members would be called back to Washington. In that sense, the dynamics would look very similar to those surrounding the long August recess, when the Capitol was virtually empty.

We must remember in this regard that the House can now vote virtually.

The House Problem Solvers Caucus which is truly bipartisan has offered its own COVID-19 relief proposal. The New York Times explains that

Lawmakers had acknowledged that the plan was unlikely to become law. But in unveiling it, the group sought to signal to Ms. Pelosi and the lead White House negotiators — Mark Meadows, the chief of staff, and Steven Mnuchin, the Treasury secretary — that there was ample common ground to be found in talks that have been dormant for weeks.

Health Payer Intelligencer reports that UnitedHealthcare has teamed up with Canopy Health to offer a concierge style health plan known as the California Doctors Plan to San Francisco area employers. “The payer projects that members will save up to 25 percent compared to other health plan premiums. Also, plan members will have no copay for primary care services and urgent care.” The FEHBlog enjoys reading about creative plan designs.

The HHS Agency for Healthcare Research and Quality has announced today that

the National Steering Committee for Patient Safety released Safer Together: A National Action Plan To Advance Patient Safety, which is the result of 2 years of work by 27 steering committee members who represent a diverse group of organizations and individuals, including healthcare systems, Federal agencies, provider associations, accrediting organizations, and patient advocates. Our goal was to provide healthcare system leaders with renewed momentum and clearer direction for reducing medical harm. Especially relevant during the COVID-19 pandemic, this national action plan and a companion implementation resource guide provide the latest implementation tactics, tools, and resources in a format that’s ready for immediate implementation. These important new resources are built on four foundational areas: culture, leadership, and governance; patient and family engagement; workforce safety; and learning systems.

This worthy initiative is certainly worth a gander.

In COVID-19 news

  • The National Institutes of Health have determined that substance use disorders (SUD) are linked to COVID-19 susceptibility.

By analyzing the non-identifiable electronic health records (EHR) of millions of patients in the United States, the team of investigators revealed that while individuals with an SUD constituted 10.3% of the total study population, they represented 15.6% of the COVID-19 cases. The analysis revealed that those with a recent SUD diagnosis on record were more likely than those without to develop COVID-19, an effect that was strongest for opioid use disorder, followed by tobacco use disorder. Individuals with an SUD diagnosis were also more likely to experience worse COVID-19 outcomes (hospitalization, death), than people without an SUD.

The Centers for Disease Control and Prevention (CDC) and the EU’s Joint Research Centre (JRC) will begin working with Siemens Healthineers to help standardize international antibody tests for COVID-19. This will include defining the proper concentrations of antibodies in the bloodstream—mapped to the novel coronavirus’s specific proteins—that could one day be used to establish the clinical threshold for a test to correctly determine whether a person is immune to the disease.

Finally, HHS’s Office for Civil Rights which enforces the HIPAA Privacy and Security Rules announced four settlements with different healthcare provider organizations over allegations of their non-compliance with HIPAA Privacy Rule requirements to give individuals access to their own health records.

“Patients can’t take charge of their health care decisions, without timely access to their own medical information,” said OCR Director Roger Severino. “Today’s announcement is about empowering patients and holding health care providers accountable for failing to take their HIPAA obligations seriously enough,” Severino added.

How true.

Monday Roundup

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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.

Thursday Miscellany

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The Wall Street Journal reports that the entire Senate Republican caucus, with the exception of Sen. Rand Paul, voted for the scaled down $500 billion (is that an oxymoron?) COVID-19 relief bill, but the bill failed to receive the 60 votes necessary for cloture because the Democratic caucus lined up in opposition. So we have another political issue for the election.

Thankfully, the Congress and the White House have agreed on a continuing resolution to fund the federal government into the new federal fiscal year. The House will be holding votes next week so the FEHBlog expects that the House will pass the continuing resolution and then peace out for the campaign trail. The Senate will hang around as long as it can to approve more nominations. Following the election Congress will hold a lame duck session at which point another COVID-19 relief bill is likely to be enacted.

In healthcare news —

  • The National Academies of Sciences has a detailed web page about social determinants of health that is worth a look.
  • Humana has launched value based hearth surgery and shoulder replacement programs. “””The value-based care models are part of a portfolio of payment bundles created by Humana including a Maternity Episode-of-care Model and an Oncology Model of Care. Humana also offers a Hospital Incentive Program for acute care inpatient admissions. About 2.4 million MA members and 115,000 commercial members are enrolled in value-based models, Humana has said.”
  • Fierce Biotech reports that quick, inexpensive saliva based COVID-19 tests are being piloted at Heathrow Airport in London, England. Send the tests over here.
  • The Wall Street Journal informs us that “health experts say it’s increasingly likely that several [COVID-19] vaccines could pass muster in clinical trials and become available in phases over a period of weeks and months.”

The Centers for Disease Control and Prevention sent documents last week to state officials that lay out various scenarios, including availability of a limited number of doses of two vaccines by the end of October with more doses by the end of the year. The CDC document doesn’t name the two vaccines that could become available but describes characteristics that match those of the vaccines from Pfizer and Moderna.

Experts say multiple vaccines will be needed because no single company can make enough for the whole world. Several companies have signed contracts with the federal government to supply at least 100 million doses of each vaccine in the U.S., and are planning to produce larger global supplies.

Progress.