Happy Washington’s Birthday

Electronic health records

Happy Washington’s Birthday

David Ermer–CDC, COVID vaccine mandate, COVID-19, Electronic health records, No Surprises Act, Telehealth, U.S. Healthcare–
The

The National Archives informs us

George Washington was born in Virginia on February 11, 1731, according to the then-used Julian calendar. In 1752, however, Britain and all its colonies adopted the Gregorian calendar which moved Washington’s birthday a year and 11 days to February 22, 1732.

Americans celebrated Washington’s Birthday long before Congress declared it a federal holiday. The centennial of his birth prompted festivities nationally and Congress established a Joint Committee to arrange for the occasion.

Washington’s Birthday was celebrated [as a federal holiday] on February 22nd [from 1879] until well into the 20th Century. However, in 1968 Congress passed the Monday Holiday Law to “provide uniform annual observances of certain legal public holidays on Mondays.” By creating more 3-day weekends, Congress hoped to “bring substantial benefits to both the spiritual and economic life of the Nation.”

One of the provisions of this act changed the observance of Washington’s Birthday from February 22nd to the third Monday in February. Ironically, this guaranteed that the holiday would never be celebrated on Washington’s actual birthday, as the third Monday in February cannot fall any later than February 21.

Contrary to popular belief, neither Congress nor the President has ever stipulated that the name of the holiday observed as Washington’s Birthday be changed to “President’s Day.”

From the Omicron front, Medscape reports

Average daily COVID-19 cases and hospitalizations are continuing to fall in the U.S., providing a signal that the Omicron variant is receding across the country.

* * *

Deaths are also beginning to decline, with an average of about 2,100 daily, according to the data tracker from The New York Times. More than 2,500 daily deaths were being reported in early February.

Medpage Today adds

The Omicron sublineage BA.2, which raised alarms because of its transmission advantage, accounts for just 4% of cases in the U.S., and experts suggested it’s not likely to reverse the current downward trend of cases overall.

BA.2 has certainly increased in prevalence, but its been a slow trajectory, according to CDC data. BA.1.1, another Omicron sublineage, actually became the dominant strain in the U.S. in mid-January, the agency reported, with the original lineage, B.1.1.529, currently accounting for about 23% of U.S. cases.

“The BA.2 Omicron variant is increasing in prevalence slowly in both CDC and private data,” tweeted Scott Gottlieb, MD, former FDA commissioner and current Pfizer board member. “While it may become a dominant strain in time, it appears increasingly unlikely that it will cause a significant change in the downward trajectory of the current epidemic wave.”

That has certainly been the case for South Africa, where BA.2 accounts for nearly 100% of cases, according to Tulio de Oliveira, PhD, of the Centre for Epidemic Response & Innovation in Stellenbosch.

“This comes on a background of decreasing infections,” de Oliveira tweeted. The country now has a 7-day average of about 2,500 daily infections, down from a peak of about 23,000 in mid-December.

“At present, the Omicron BA.2 is not of great concern in South Africa,” he tweeted. “But our network is following very close and is alerted to its emergence.”

From the Covid vaccination mandate front, the Society for Human Resource Management reports that the U.S. Court of Appeals for the Fifth Circuit ordered the lower court to reconsider whether United Airlines vaccination mandate offered sufficient protection under Tittle VII to religious objectors.

From the No Surprises Act front, the American Hospital Association tells us

The Centers for Medicare & Medicaid Services will host a conference call for health care providers Feb. 23 at 2 p.m. ET on the No Surprises Act’s continuity of care, provider directory and public disclosure requirements. To participate in the Special Open Door Forum, dial 888-455-1397 and reference passcode 5109694. Slides for the call are available here. Participants may email questions in advance to Provider_Enforcement@cms.hhs.gov. A recording will be available after the call through Feb. 25 by dialing 866-373-4993.

The slide deck is quite detailed.

Healthcare Dive adds

The cost of being transported by ground ambulance has increased steadily over the past five years, according to a new report from nonprofit Fair Health, threatening patients with few protections from balance billing in disputes between insurers and ambulance providers.

More ambulance trips are billing payers for advanced life support ( ALS), denoting a higher level of care (and reimbursement) than basic life support (BLS) services. Private insurers’ average payments for those trips increased 56% between 2017 and 2020, from $486 to $758, according to the analysis. Before accounting for discounts negotiated with payers, the rate that ambulance operators charged for trips jumped 23% in the same time period and now average almost $1,300.

However, the average reimbursement for advanced life support ambulance rides climbed by 5% for patients covered by Medicare, from $441 to $463, suggesting the government program is keeping a lid on rising costs.

Although at this point only air ambulance charges are subject to the No Surprises Act, this type of report could lead Congress to expand the law to include ground ambulance charges.

From the medical research front, Biopharma Dive informs us

Eli Lilly is again upping its investment in genetic medicine, announcing Tuesday plans to establish a Boston research center that will use RNA- and DNA-based technologies to develop new drugs.

The Lilly Institute for Genetic Medicine will take up 334,000 square feet in Boston’s Seaport neighborhood, with occupancy slated to begin in 2024. Lilly, which has earmarked around $700 million for the project, expects the institute to grow from 120 employees to 250 within five years. Roles will include data scientists, chemists and research biologists with expertise in genetic medicine.

Alongside drug development, the institute will take a page from another Lilly venture — Lilly Gateway Labs — and offer shared lab and office space to support biotechnology startups in the area. Use of the shared space, Lilly said, could create as many as 150 additional new jobs once it’s fully occupied.

The National Institutes of Health announced

Women who had ever experienced sexual violence in their lifetime — including sexual assault and workplace sexual harassment — were more likely to develop high blood pressure over a seven-year follow-up period, according to findings from a large, longitudinal study of women in the United States. The research, funded by the National Institutes of Health and published in the Journal of the American Heart Association, indicated that sexual violence was a common experience, affecting more than 20% of the women in the sample.

“Our results showed that women who reported experiencing both sexual assault and workplace sexual harassment had the highest risk of hypertension, suggesting potential compounding effects of multiple sexual violence exposures on women’s cardiovascular health,” said Rebecca B. Lawn, Ph.D.(link is external), of the Harvard T. H. Chan School of Public Health, Boston, lead author on the study.

From the healthcare initiative front, the Centers for Disease Control detailed its Million Hearts 2027 initiative.

From the virtual care front, Healthcare IT News tells us

The American Medical Association, in conjunction with Manatt Health, published a report this week exploring the ways that virtual care and other digital tools can accelerate the adoption of the integrated delivery of behavioral and physical healthcare.  

In the report, the organizations note that behavioral health integration is essential for solving the country’s dire need for access to services.  

“The demand for behavioral health services is significant and rising, but so is the potential for digital technology to support the integrated delivery of physical and behavioral health services,” said AMA President Dr. Gerald Harmon in a statement.  

Moreover, in Health Affairs, the National Coordinator for Health Information Technology Micky Tripathi discusses delivering on the promise of health information technology in 2022.

From the healthcare business front, Healthcare Finance reports

The Department of Justice has until Saturday, February 27 to block the merger between UnitedHealth Group and Change Healthcare, according to a Securities and Exchange Commission filing on February 17.

The filing, by Change, was done in accordance with a timing agreement made with the DOJ. In November 2021, the two companies agreed not to consummate their merger before February 22. 

The timing agreement provides the DOJ with 10 days’ notice to sue to block the deal. 

“Effective February 17, 2022, UnitedHealth Group and the Company provided such notice to the DOJ,” Change said in the filing. “Accordingly, the DOJ now has until February 27, 2022 to initiate litigation to block the consummation of the merger.”

The DOJ is preparing the lawsuit to block UnitedHealth from purchasing Change, according to Seeking Alpha.

From the awards front

  • STAT News released its inaugural STATUS List which “recongizes standout individuals in health, medicine, and science. And although there are countless contenders to choose from, we’ve selected just 46 — an homage to the number of chromosomes in human DNA.”
  • OPM “announced a call for nominations for the 2022 Presidential Rank Awards (PRAs). A Presidential Rank Award is one of the most prestigious awards in the federal career civil service, and these awards are critical to recognizing the hard work and important contributions of dedicated civil servants in the American federal workforce. The awards – which recognize exceptional performance by members of the career Senior Executive Service (SES) and Senior Career Employees – reflect the Biden-Harris Administration’s commitment to supporting the federal workforce and recognizing federal employees who serve with distinction.” The nomination deadline is March 25, 2022.  

Tuesday’s Tidbits

David Ermer–CDC, Congress, COVID-19 vaccine, Electronic health records, Mental health care, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the Capitol Hill front —

The Wall Street Journal reports

Sen. Marsha Blackburn lifted a hold on a stopgap bill needed to avoid a partial government shutdown this weekend after she won a commitment from the Biden administration that it wouldn’t fund pipes for smoking illicit substances through a substance-abuse program. * * *

[Senate Minority Leader Sen. Mitch] McConnell said Tuesday that he expected there to be some amendment votes in conjunction with the vote on the so-called continuing resolution. “I think it will all be worked out,” he said. “There’s no danger of a government shutdown.”

The House of Representatives held a pro forma, the four-minute-long session this morning at which

[The] Clerk notified the House that she had received the following message from the Secretary of the Senate on February 14, 2022, at 6:30 p.m.: That the Senate agreed to return the papers to the House of Representatives at their request for H.R. 3076 [the Postal Reform Act of 2022] * * *.

The House is not scheduled to resume floor voting until February 28 and the Senate will be on a State work period next week so Congressional passage of this bill may not occur until next month.

FInally Roll Call reports

The Senate on Tuesday confirmed Robert Califf to lead the Food and Drug Administration, 50-46, a much narrower vote than when he previously held the position during the Obama administration, though many thought the latest vote could be even closer.

Califf’s confirmation means the Biden administration has a permanent FDA commissioner during the COVID-19 pandemic after 13 months with longtime agency official Janet Woodcock acting as its leader.

Califf needed bipartisan support to cross the finish line. Retiring Sens. Patrick J. Toomeyof Pennsylvania and Roy Blunt of Missouri joined four Republicans who sit on the Health, Education, Labor and Pensions Committee to confirm Califf.

From the Omicron front, the Wall Street Journal offers interesting commentary from Dr. Marc Siegal about the Novovax vaccine which is the subject of an emergency use authorization at the Food and Drug Administration.

The Novavax vaccine is based on tried and true technology. It involves growing the virus’s spike protein in moth cells and then combining it with an adjuvant, a chemical that amplifies the protein’s effect on the immune system. Whereas the mRNA vaccines signal human cells to make part of the protein, Novavax injects it directly as a “nanoparticle,” which induces a robust immune response (antibodies and T-cells). Side effects appear to be minimal: flulike symptoms, headache, temporary fatigue and pain at the injection site.

There are several reasons to think that Novavax may give a more powerful boost than a third or fourth mRNA shot. For one thing, the nanoparticle includes the whole spike protein, which could provoke a more complete immunity. So could the glycosylation of the spike—the addition of a sugar molecule in insect cells, which isn’t what the virus is expecting. Perhaps most important, the adjuvant (known as Matrix-M1), which comes from the inner bark of a Chilean soapbark tree, is very high in quality and has been used to make a malaria vaccine effective.

From the health equity front, Health Payer Intelligence discusses a Northeast Business Group on Health report on strategies for making progress on resolving inequities created by social determinants of health. Check it out.

In a similar vein, the Agency of Healthcare Research and Quality blog post on integrating patient-generated health data into electronic health records.

The 63-year-old patient has hypertension. With encouragement from his family, he checks his blood pressure daily using a digital blood pressure monitor. And thanks to advances in digital technology, he saves each reading on a mobile application whether he’s at home, at work, or on vacation.

What is the reward for his persistence? With his health data easily integrated into his electronic health record, his primary care doctor has a fuller picture of his health—one that is not limited to the traditional snapshot taken in an exam room. Using that data, he and his physician can have more informed conversations about treatment options and next steps.

While this scenario accurately recognizes that today’s patients can easily collect their own health data outside of the clinical setting, many ambulatory care practices lack the technical infrastructure, functional workflows, workforce capacity, and training to support the intake and use of patient-generated health data (PGHD).

With those challenges in mind, AHRQ has released a new guide on increasing the use of PGHD, one that provides practical tools for ambulatory care practices to implement PGHD programs and improve patient outcomes. It includes tips, ideas, and learning activities to let users tailor solutions to their needs. To our knowledge, this is the first practical guide that includes detailed considerations and steps for implementing a PGHD program.

The AHRQ guide may be helpful to health plan case managers, too.

From the tidbits department

  • Roll Call and Fierce Healthcare offer different takes on the public comments submitted on the Centers for Medicare Services controversial proposed national coverage deterimination on Biogen’s Alzheimers Disease drug Aduhelm. A final decision is expected in April.
  • The CDC encourages people with pre-diabetes to become heart health role models.

Cigna’s Evernorth is adding Monument’s virtual care services to its behavioral health network, the insurer announced Tuesday.

The platform is now available to all Evernorth clients and to Cigna members in employer plans or Affordable Care Act marketplace plans in 20 states.

Monument offers an evidence-based, virtual treatment program for alcohol use disorder. Evernorth said in the announcement that alcohol use has been on the rise for the past several decades, and that some 60% of people have reported higher alcohol intake under the pandemic.

Weekend Update

David Ermer–Congress, COVID-19, COVID-19 vaccine, Electronic health records, Rx coverage, U.S. Healthcare–

Both Houses of Congress will be engaged in Committee business and floor voting this week as we are now less than one month away from the expiration of the current continuing resolution funding the federal government. That resolution runs through February 18.

From the Omnicron front, the New York Times reports that ‘

New coronavirus cases have started to fall nationally, signaling that the Omicron-fueled spike that has infected tens of millions of Americans, packed hospitals and shattered records has finally begun to relent.

More and more states have passed a peak in new cases in recent days, as glimmers of progress have spread from a handful of eastern cities to much of the country. Through Friday, the country was averaging about 720,000 new cases a day, down from about 807,000 last week. New coronavirus hospital admissions have leveled off.

Even as hopeful data points emerge, the threat has by no means passed. The United States continues to identify far more infections a day than in any prior surge, and some states in the West, South and Great Plains are still seeing sharp increases. Many hospitals are full. And deaths continue to mount, with more than 2,100 announced most days.

But following a month of extraordinary rates of case growth, blocklong lines at testing centers and military deployments to bolster understaffed I.C.U.s, the declining new-case tallies offered a sense of relief to virus-weary Americans, especially in the Northeast and parts of the Upper Midwest, where the trends were most encouraging. After another round of masking up or hunkering down, some were considering what life might look like if conditions continued to improve. 

Bloomberg adds

The omicron variant spreads so rapidly that sometimes it feels as if resistance is futile. It’s disheartening to hear of omicron infecting people who are up-to-date on their shots and wear an N95 mask every time they leave home. Even some well-known public-health experts are getting infected. But that doesn’t mean everyone is going to get it. 

What it does mean is that life is profoundly unfair. In some of us, the Covid-19 vaccines work quite robustly, even against omicron. In others, the vaccines’ effect is weaker. Chalk this up to the spectacular diversity of the human immune system, which is partly regulated by some of the most varied genes in the human body. 

A recent study led by Harvard and MIT showed that about 20% of people get much poorer protection from their vaccines against omicron. They’re still better off than completely unvaccinated people, but this variability could account for some of the fully vaccinated people who’ve been hospitalized in the omicron wave.

According to the American Medical Association (AMA), here’s what physicians want their patients to know about Omicron. “The AMA has developed frequently-asked-questions documents on COVID-19 vaccination covering safety, allocation and distribution, administration and more. There are two FAQs, one designed to answer patients’ questions (PDF), and another to address physicians’ COVID-19 vaccine questions (PDF).”

From the Rx coverage front, the New York Times offers an interview with CVS Health’s CEO Karen Lynch. For example,

What do you see as the most effective ways that we could reduce health care costs for everyday Americans? And what’s your company’s role in doing that?

There’s a couple of things. One is there’s the site of care. Our role is offering an alternative site of care, either in our retail locations, or in the home with virtual connections. We’re entering into the primary care space because we believe that primary care has real significant influence over the cost of health care.

And I’m pretty passionate about the fact that the head is attached to the body, and most people experience behavioral health issues when they are experiencing physical health issues. We only deal with the physical health. We don’t deal with the behavioral health part, and I think there’s more we can do.

Healthcare Dive provides us with industry perspective on last week’s launch of TEFCA which is intended to vastly improve interoperability by linking together regional health information exchanges.

The goal of TEFCA is to get rid of individual legal agreements between health information networks, health plans, providers and other entities by instituting one common agreement that qualified networks and their participants sign onto, paring back on administrative burden. The framework standardizes the operational side of data exchange, while raising the privacy and security bar for entities that want to be certified as qualified health information networks (QHINs), groups of organizations that agree to the same data-sharing infrastructure. * * *

Getting a nationwide network of groups of organizations that agree to the same data-sharing infrastructure could significantly streamline patient care across different geographies.

For example, if a patient from Virginia takes a vacation to California and ends up in an emergency room, doctors currently do the best they can to treat them without their medical record, which can contain valuable information about preexisting conditions, allergies and other health factors. But with a nationwide QHIN infrastructure, clinicians can query all participating networks for that patient’s data and use it to inform their clinical choices, Barrett said.

That budding future all centers on buy-in. * * *

Many, including ONC, are optimistic on TEFCA adoption, citing the competitive disadvantages to nonparticipation.

The hope is that the more networks use it, the more its value proposition will be proved. Patients will inquire why their provider doesn’t have their data from other facilities, and the provider will then wonder why the exchanges it’s a participant in aren’t qualified to work with other networks, Lee Barrett, CEO of EHR standards development organization EHNAC said.

Tuesday Tidbits

David Ermer–COVID treatment, COVID-19, COVID-19 testing, Electronic health records–
Photo by Patrick Fore on Unsplash

Back in President George W. Bush’s first term, health information professionals were talking about the linking budding health information exchanges with a “national backbone.” That backbone was finally unveiled today and it has been named TEFCA. Hopefully TEFCA will be the answer to nationwide FEHB plan prayers for interoperability.

An Office of National Coordination press release explains,

The Trusted Exchange Framework and Common Agreement is now available. Within the health information technology (health IT) world, few things have been as elusive as a governance framework for nationwide health information exchange. When ONC was formed in 2004, the concept of a nationwide health information network—where your information could be located across the country in a click—was a big picture vision that drove the federal government’s early health IT infrastructure, standards, policy actions, and investments.

What’s followed as a result of two laws (HITECH Act and 21st Century Cures Act) and remarkable continuity across four administrations has been steady growth, maturity, and investment from both the public and private sectors. Most health care providers use electronic health records.1,2,3 Many are connected to and engage in at least one form of electronic health information exchange.4,5,6 And health information networks are now dotted across the US map supporting communities with a wide range of services.7

Today’s milestone marks the beginning of a new era of electronic health information exchange in the US. That world we wanted to see back in 2004—it’s here—and now it’s time to put what we’ve built to use.

Our goals for the Trusted Exchange Framework and Common Agreement (TEFCA) are:

Goal 1: Establish a universal policy and technical floor for nationwide interoperability.

Goal 2: Simplify connectivity for organizations to securely exchange information to improve patient care, enhance the welfare of populations, and generate health care value.

Goal 3: Enable individuals to gather their health care information.

The Trusted Exchange Framework is a set of non-binding principles to facilitate data-sharing among health information networks. The Common Agreement will operationalize simplified electronic health information exchange for many across the US and will provide easier ways for individuals and organizations to securely connect. Most notably, the Common Agreement sets a new baseline for the exchange purposes that need to be supported—a common source of friction across networks today. The Common Agreement includes support for treatment, payment, health care operations, individual access services, public health, and government benefits determination.

The Common Agreement is a new legal contract that ONC’s Recognized Coordinating Entity (RCE), The Sequoia Project, will sign with each Qualified Health Information Network (QHIN). QHINs will then execute certain corresponding policies within their own networks. Published in tandem is the QHIN Technical Framework, which sets the functional and technical requirements that QHINs need to support to make this new connectivity come online. While road-tested production standards are being used at the start, we are also actively working with the RCE to develop a TEFCA Health Level Seven (HL7®) Fast Healthcare Interoperability Resource (FHIR®) Roadmap (TEFCA FHIR Roadmap) to outline how FHIR will also become an established part of TEFCA-based exchange over time.

The FEHBlog is happy that the Biden Administration hit the regulatory accelerator to launch TEFCA in the Administration’s first year in office. Here’s a link to the Sequoia Projects’ TEFCA website which offers a wealth of resources.

From the Omicron front, the Wall Street Journal reports that

Pfizer Inc.’s new Covid-19 pill, Paxlovid, was effective against the Omicron variant in laboratory tests, an encouraging early sign the drug will be an important tool while the strain spreads. 

Pfizer said Tuesday the drug’s main component, nirmatrelvir, worked in three separate laboratory studies. Patients take two tablets of nirmatrelvir with one tablet of another antiviral called ritonavir twice a day for five days.

The company issued the results by news release. The research hasn’t been published in a peer-reviewed medical journal.

PBS recently posted this helpful article on U.S. distribution plans for the Merck and Pfizer COVID pills. The pills are helping some folks already, but access to the medication seems serendipitous just like access to the COVID vaccines seemed a year ago.

From the OTC testing front, the Federal Government launched its COVIDTest.gov website today. The site appears to be user friendly. Let’s hope it’s holds up better than healthcare.gov did in 2014 when stress tested by the public.

The COVIDtests.gov reminds users that health plans will reimburse the costs of OTC Covid tests, and by golly Blue Cross FEP has an OTC tests coverage page on its website and so does GEHA.

Weekend update

David Ermer–Congress, COVID-19, Electronic health records, OPM, Telehealth, U.S. Healthcare–
Photo by Dane Deaner on Unsplash

The Senate remains in session for Committee and floor business while the House of Representatives remains on its District work break. Politico reports from the Senate floor that

The bipartisan infrastructure deal embraced by President Joe Biden and shaped by a gang of 10 senators is inching closer to clearing the chamber, with one more filibuster to clear on Sunday before the bill can pass later this week and land in the the House. * * *

[House Speaker] Pelosi and Senate Majority Leader] Schumer have devised a two-track process to enact as much of Biden’s domestic agenda as possible, pledging that the bipartisan infrastructure bill will only advance if it is married to the party-line legislation that will spend as much as $3.5 trillion on climate change action, paid leave policies and health care expansion. 

The Senate will immediately proceed to a budget setting up that massive bill on filibuster-proof ground after it completes its work on the bipartisan infrastructure bill. Schumer is also considering forcing votes on more elections legislation after Democrats’ sweeping overhaul plan failed in June.

From the Delta variant front

  • The CDC’s COVID Data Tracker informs us today that just over two thirds of Americans over age 12 and 90% of Americans over 65 have received at least one dose of a COVID-19 vaccine. The data tracker consistently has shown a 10% difference between one dose and fully vaccinated Americans which indicates to the FEHBlog that people follow through a get the second dose.
  • However, the Wall Street Journal reports about how neighbor deaths from unvaccinated neighbors has caused an Arkansas town to reconsider their reluctance to receive the COVID-19 vaccine. Another Journal article adds that “Top U.S. public-health officials on Sunday [August 8] voiced support for Covid-19 vaccination mandates imposed at the local level, while the head of a national teachers union also backed such a move in schools.”
  • Speaking of mandates, the FEHBlog found a link to the Safer Federal Workers Task Force FAQs on the Biden Administration’s vaccine screening program for federal employees, federal office visitors and on-site contractors that were released last Friday August 6. Interestingly, an FAQ indicates that

Q: Do agencies need to ask employees on maximum telework or remote workers about their vaccination status?

A: Yes, agencies should provide the Certification of Vaccination form to all employees, including employees on maximum telework and remote workers.

Healthcare Dive informs us about

  • Five intriguing panels at this week’s in-person HIMSS conference in Las Vegas.
  • A new survey conducted by Social Sciences Research Solutions for the Bipartisan Policy Center [that] concludes that telehealth is likely an ongoing viable option for consumers even after the COVID-19 pandemic winds down.
  • An overview of second quarter financial reports from health insurers.

The Biden Administration to its credit has proposed a rule rescinding the Trump Administration’s rule to establish a most favored nation pricing approach for Medicare Part B covered drugs.

Govexec reports on a recent Postal Service Board of Governors meeting attended by the three recently confirmed members whom President Biden had nominated. “The tenure of the U.S. Postal Service’s newest board members got off to a tense start on Friday as President Biden’s appointees voiced their displeasure with the agency’s direction and USPS’ leader stated he will still move forward with reforms.”

Thursday Miscellany

David Ermer–Congress, COVID-19 vaccine, Electronic health records, Medicare, Mental health care, OPM, U.S. Healthcare–
Photo by Juliane Liebermann on Unsplash

Fierce Healthcare tells us that “Johnson & Johnson’s COVID-19 vaccine presents greater benefits than it does safety risks, especially amid the quickly spreading Delta variant, a key CDC expert panel [,the Advisory Committee on Immunization Practices] decided [today]. However, the panel said that a ruling over the need for a booster added to all COVID shots will have to start with the FDA.”

Fedweek reports that “Federal employees, their unions and members of Congress continue to watch for details of federal agency ‘reentry’ and ‘post-reentry’ operational plans, with the deadline having passed on Monday (July 19) for agencies to submit those plans to OMB but with changes to telework and other workplace policies likely still weeks or months away.”

According to a press release,

Senators Patrick Leahy (D-Vt.) and Steve Daines (R-Mont.) on Tuesday [July 20] requested updates from both the Federal Trade Commission (FTC) and the Department of Justice (DOJ) on their recent efforts to combat anticompetitive conduct in the health insurance industry.  The two senators recently served as chief cosponsors of the bipartisan Competitive Health Insurance Reform Act (CHIRA), which protects consumers by repealing a long-outdated antitrust exemption for the health insurance industry.  Decades of consolidation by health insurance brokers has primed the industry for abuse, allowing insurers to exert market power in order to raise premiums, restrict competition, and deny consumers choice. 

Since the CHIRA’s passage in January of this year, neither the FTC nor the DOJ has announced major steps to exercise their expanded antitrust enforcement authority under the new law.  In their letter, the senators called on the agencies to provide information on any enforcement actions, guidelines, rulemaking, or other actions taken to extend antitrust enforcement to the health insurance industry since then.

Following up on Mondays’ ACA FAQ 47, HHS today announced “the launch of The HIV Challenge, a national competition to engage communities to reduce HIV-related stigma and increase prevention and treatment among racial and ethnic minority people. Through this challenge, HHS is seeking innovative and effective approaches to increase the use of pre-exposure prophylaxis medication (PrEP) and antiretroviral therapy (ART) among people who are at increased risk for HIV or are people with HIV. The HIV Challenge is open to the public, and HHS will award a total of $760,000 to 15 winners over three phases. Phase 1 submissions are open from July 26, 2021, through September 23, 2021.”

Kaiser Health News explains how the Centers for Medicare and Medicaid Services is reevaluating its wellness program for pre-diabetic Medicare beneficiaries.

Over the past decade, tens of thousands of American adults of all ages have taken these diabetes prevention classes with personalized coaching at YMCAs, hospitals, community health centers and other sites. But out of an estimated 16 million Medicare beneficiaries whose excess weight and risky A1c level make them eligible, only 3,600 have participated since Medicare began covering the two-year Medicare Diabetes Prevention Program (MDPP) in 2018, according to the federal government’s Centers for Medicare & Medicaid Services (CMS).

Researchers and people who run diabetes prevention efforts said participation is low because of the way Medicare has set up the program. It pays program providers too little: a maximum of $704 per participant, and usually much less, for dozens of classes over two years. It also imposes cumbersome billing rules, doesn’t adequately publicize the programs and requires in-person classes with no online options, except during the pandemic emergency period. Most of the private Medicare Advantage plans haven’t promoted the program to their members.

Now, CMS has proposed to address some but not all of those problems in a rule change. It predicted the changes would reduce the incidence of diabetes in the Medicare population and potentially cut federal spending to treat diabetes-related conditions.

STAT News reports that

Leveraging Food and Drug Administration regulations loosened during the pandemic, Happify Health, which is best known for its consumer wellness app, will launch new prescription-only software to treat depression.

Happify, founded in 2012, recently announced it had raised $73 million to bolster its efforts in digital therapeutics, a space that is rapidly growing as well-funded companies make the case to regulators, insurers, and clinicians that software can be used to treat disease.

The new product, called Ensemble, is designed to treat both major depressive disorder and generalized anxiety disorder. The software, accessible on both computers and smartphones, guides patients through 10 weeks of cognitive behavioral therapy, or CBT, and other related techniques aimed at changing behavior patterns and teaching coping skills.

The FEHBlog likes the company’s name.

The American Medical Association wants the Food and Drug Administration to loosen up on its opioid prescribing rules which conflict with patient care. Perhaps the FEHBlog is oversimplifying this issue, but haven’t we been down this road to perdition before?

In closing, Fierce Healthcare notes that

Large tech giants are jumping into a growing interoperability solutions market as new federal regulations spur the healthcare industry to open up and share medical records data.

Google Cloud rolled out a new tool called the healthcare data engine, currently in private preview, that helps healthcare and life sciences organizations harmonize data from multiple sources, including medical records, claims, clinical trials and research data.

It gives organizations a holistic view of patient longitudinal records, and enables advanced analytics and AI in a secure and compliant cloud environment, according to Google Cloud executives.

Friday Stats and More

David Ermer–COVID-19, COVID-19 vaccine, Electronic health records, Rx coverage, SCOTUS, U.S. Healthcare–

Based on the Centers for Disease Control’s COVID-19 Data Tracker website, here is the FEHBlog’s chart of new weekly COVID-19 cases and deaths over the 14th week of 2020 through 24th week of this year (beginning April 2, 2020, and ending June 16, 2021; using Thursday as the first day of the week in order to facilitate this weekly update):

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

The FEHBlog has noticed that the new cases and deaths chart shows a flat line for new weekly deaths because new cases materially exceed new deaths. Accordingly here is a chart of new COVID-19 deaths over the period (April 2, 2020, through June 16, 2021):

Finally here is a COVID-19 vaccinations chart over the period December 17, 2020, through June 16, 2021 (six months) which also uses Thursday as the first day of the week:

Bloomberg reports that

President Joe Biden urged unvaccinated Americans to get inoculated from coronavirus, warning that the highly transmissible delta variant of the virus could cause more deaths. “Even while we are making incredible progress [as reflected above], it remains a serious and deadly threat,” Biden said Friday during a White House event to celebrate 300 million doses of vaccine administered during the first 150 days of his administration.“The data is clear: If you are unvaccinated, you’re at risk of getting seriously ill, or dying, or spreading it.” A large swath of Americans — particularly in the politically conservative South — have declined shots despite warnings from health authorities that the virus remains a threat.”

in other COVID-19 news

  • Medscape informs us that “While the investigation into cases of myocarditis possibly associated with COVID vaccines proceeds, the American Heart Association (AHA)/American Stroke Association (ASA) continue to urge everyone who is eligible for the vaccine to get it without delay. ‘We remain confident that the benefits of vaccination far exceed the very unusual risks,’ the leadership of the AHA/ASA said in a statement issued June 12. ‘The risks of COVID-19 infection include its potentially fatal consequences and the potential long-term health effects that are still revealing themselves, including lingering consequences affecting the heart, brain, vascular system, and other organs after infection,’ they point out. Late last week, the Centers for Disease Control and Prevention (CDC) alerted healthcare providers that the COVID-19 Vaccine Safety Technical Work Group (VaST) of the Advisory Committee on Immunization Practices (ACIP) will meet June 18 to review cases of myocarditis reported in adolescents and young adults after they received a COVID-19 vaccine manufactured by Pfizer–BioNTech or Moderna.
  • MedPage Today reports that “During the American Medical Association (AMA) House of Delegates annual meeting, members debated whether natural immunity or previous infection with SARS-CoV-2 was sufficient for the merit of immunity credentials.” The House of Delegate voted against treating natural immunity as equivalent to vaccination. “Multiple delegates pointed out that using natural immunity in lieu of vaccination would pit the AMA’s recommendations against those of the CDC.” Nevertheless as the Mayo Clinic points out, natural immunity helps us achieve some level of herd immunity. It needs to be considered with vaccinations for that purpose.

If you want more details on yesterday’s Affordable Care Act decision from the U.S. Supreme Court, check out Prof. Katie Keith’s post in the Health Affairs blog.

Beckers Hospital News lists seven Fortune 500 health insurers by membership. Health Payer Intelligence discusses the latest sustainability report from the company that tops this list, UnitedHealth Group.

On this Juneteenth holiday, Fierce Health tells us about how “healthcare executives call on President Biden to take ‘innovative, bold’ steps to tackle health equity using AI, big data.”

“It’s not a lack of data—we have so much data in this country now, in our healthcare systems and our EHRs and our patient registration systems,” Cole said. “The data is there but the analytics capability of that—what to do with that data—is something that we’re continuing to work on every day.”

Cole and John Lumpkin, M.D., president of the Blue Cross and Blue Shield of North Carolina Foundation, said both of their organizations have been reworking their collection and organization of race, ethnicity, gender identity and other related data tied to health inequity—a change that “should be a very simple thing to do” but requires an internal data system overhaul, Lumpkin said.

Still, executives said the finish line of those efforts is worthwhile. Incorporating SDOH data can yield substantial health and costs benefits at the individual and population levels, they said.

The Wall Street Journal reports on the rising fortunes of the country’s major pharmacy chains, CVS Health and Walgreens.

In health system merger news —

  • Healthcare Dive informs us that “Beaumont Health and Spectrum Health are looking to merge in a deal that would result in Michigan’s biggest health system with 22 hospitals and 64,000 employees across the state, with combined annual revenue of almost $13 billion. Executives of the two systems announced Thursday they have signed a letter of intent to explore creating a joint health system. The deal would include Spectrum’s Michigan-based health insurance plan, Priority Health, which has 1.2 million customers.”
  • Fierce Healthcare reports that “Southern health systems Ochsner Health and Rush Health Systems have announced plans for a merger they expect to be completed about halfway through 2022. The deal follows a 2019 strategic partnership between the two nonprofit providers and comes hot on the heels of Louisiana-based Ochsner’s merger with Lafayette General Health, which closed in October 2020 and grew the system to 35 hospitals. Rush, which has seven hospitals and more than 30 clinics in eastern Mississippi and western Alabama, will be rebranded as Ochsner Rush Health should the merger receive regulatory approval.”
  • Healthcare Dive also tells us that “Tenet, a major U.S. health system, has agreed to sell five hospitals in the Miami-Dade area for $1.1 billion to Steward Health Care System, a physician-owned hospital operator and health network. The deal also includes the hospitals’ associated physician practices. Dallas-based Steward has agreed to continue using Tenet’s revenue cycle management firm, Conifer Health Solutions, following the completion of the deal, which is expected to close in the third quarter. Further underscoring Tenet’s strategic focus, the sale will not include Tenet’s ambulatory surgery centers in Florida. Tenet will hold onto those assets as its ambulatory business becomes a bigger focus for the legacy hospital operator.”

Monday Roundup

David Ermer–COVID-19, COVID-19 vaccine, Electronic health records, Medicare, OPM, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

The Food and Drug Administration (“FDA”) announced today that the agency has “approved Aduhelm (aducanumab) for the treatment of Alzheimer’s, a debilitating disease affecting 6.2 million Americans. Aduhelm was approved using the accelerated approval pathway, which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments. Accelerated approval can be based on the drug’s effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients, with a required post-approval trial to verify that the drug provides the expected clinical benefit. 

“Under the accelerated approval provisions, which provide patients suffering from the disease earlier access to the treatment, the FDA is requiring the company, Biogen, to conduct a new randomized, controlled clinical trial to verify the drug’s clinical benefit. If the trial fails to verify clinical benefit, the FDA may initiate proceedings to withdraw approval of the drug.”

The Wall Street Journal adds

Biogen priced the newly approved drug higher than analysts expected. The company said it would charge about $56,000 a year per patient.

A preliminary analysis conducted by the Institute for Clinical and Economic Review, a nonprofit research and advisory group, said the drug could be cost-effective at a per-patient price of $2,500 to $8,300 a year.

Alzheimer’s is a progressive degenerative disease that slowly robs people of their memory and the ability to care for themselves.

About six million people suffer from Alzheimer’s in the U.S. Of those, as many as 1.4 million could be eligible to take Aduhelm, according to estimates by Cigna.

What’s more, according to the Journal,

Cigna will likely cover the drug for people who match the patients studied in Biogen’s clinical trials—those with early-stage Alzheimer’s and amyloid buildup in their brains—said Steve Miller, Cigna’s chief clinical officer.

Most Alzheimer’s patients are covered by Medicare, and their out-of-pocket costs could be significant, depending on their coverage, because of so-called coinsurance payments that require patients to cover a percentage of certain health costs, Dr. Miller said.

“The out-of-pocket testing costs could be a real barrier for those patients who lack the financial means,” said Dr. Miller.

Cigna estimates that patients with traditional Medicare insurance could be on the hook for more than $10,000 a year in coinsurance and copayments for the drug and amyloid testing, Dr. Miller said. Additional costs for people with supplemental Medigap insurance or commercial coverage through Medicare Advantage could reach up to $4,000 annually.

Dr. Miller said patients may be eligible for financial assistance to cover the extra costs through nonprofit foundations, which are often funded by drugmakers.

Healthcare Dive offers a comprehensive article about the new drug that is not behind a paywall.

From the COVID-19 front

  • David Leonhardt in the New York Times reports on his takeaways from Britain’s recent, modest rise in new COVID-19 cases:

One, vaccines are still the most effective way, by far, to defeat this terrible pandemic. Nothing matters more than the speed at which shots go into arms — in Britain, in the U.S. and especially in poorer countries, where vaccination rates are still low.

Two, behavior restrictions can still play a role in the interim. If hospitalizations or deaths in Britain rise over the next two weeks, there will be a strong argument for pushing back the full reopening of activities. And that has obvious implications for the U.S., too. Restricting indoor activities for unvaccinated people is particularly important.

Three, caseloads are no longer as important a measure as they used to be. Before the vaccines were available, more cases inevitably meant more hospitalizations and deaths. Now, the connection is more uncertain. As a recent Times story put it, paraphrasing British scientists, “upticks in new infections are tolerable so long as the vast majority do not lead to serious illness or death.”

  • The Society for Human Resource Management discusses stepped-up employer efforts to encourage COVID-19 vaccinations and reduce employee tensions over COVID-19 masks and vaccination in the workplace.
  • Medscape offers suggestions for healthcare providers and possible health plans on how to target COVID-19 vaccine hesitancy.
  • The Massachusetts Institute of Technology’s Pandemic Technology Project reports on best community practices in closing COVID-19 vaccination gaps.

From the OPM front

  • Govexec informs us that OPM “on Monday moved to finalize new regulations making it easier for federal agencies to bring back former employees at a higher salary than when they left government. Currently, federal agencies have the authority to rehire former federal workers outside the competitive hiring process, but they can only offer them positions at the same pay grade they held before they left federal service. Under a final rule set to be published in the Federal Register Tuesday, effective July 8, agencies will be able to use that process to rehire former federal workers at higher salaries than when they left government, accounting for the experience and skills they gained through education and the private sector.”
  • Federal News Network informs us that “Federal retirement activity slowed across the board last month, from new claims to backlogged cases and even the time it takes to process them. The latest numbers from the Office of Personnel Management showed that 7,684 new claims were filed in May compared to 9,414 in April — an 18.4% decrease month over month but a 15.6% increase from the same time a year ago. The number of claims processed also dropped to 8,451 in May versus 11,396. That’s a 25.8% decline month other month, although April was unusually high for processed claims when compared to historical monthly totals. May’s processed claims were about even year over year. The retirement backlog decreased from 25,386 claims in April to 24,619 claims in May, but that represented a 35.4% increase from May 2020. In January of this year, the backlog, which has not met it’s goal of 13,000 claims for more than a year and a half, peaked at 26,968 claims and has slowly inched back down.” It’s the FEHBlog’s understanding that OPM’s issues stem from an unnecessarily complex federal retirement system that only Congress can fix.

In other news

  • Beckers Hospital Review reports that “Walmart Health’s primary care medical group has filed paperwork to expand virtual care in 16 more states, Insider reported June 7.”
  • Healthcare Dive informs us that even before the new information blocking rule’s effective date, “the majority of hospitals have allowed patients to view and download their health information via their own patient portal [in recent year] . However, hospitals allowing patients to use third-party apps to see their data increased sharply from 2018 to 2019, according to a new report from the federal agency that regulates U.S. health IT.”

Monday Roundup

David Ermer–Congress, COVID-19, COVID-19 vaccine, Electronic health records, Mental health care, OPM–
Photo by Sven Read on Unsplash

The big news today is Astra Zeneca’s announcement that its two dose COVID-19 vaccine “demonstrated statistically significant vaccine efficacy of 79% at preventing symptomatic COVID-19 and 100% efficacy at preventing severe disease and hospitalisation.

This interim safety and efficacy analysis was based on 32,449 participants accruing 141 symptomatic cases of COVID-19. The trial had a 2:1 randomisation of vaccine to placebo.

Vaccine efficacy was consistent across ethnicity and age. Notably, in participants aged 65 years and over, vaccine efficacy was 80%.

The vaccine was well tolerated, and the independent data safety monitoring board (DSMB) identified no safety concerns related to the vaccine. The DSMB conducted a specific review of thrombotic events, as well as cerebral venous sinus thrombosis (CVST) with the assistance of an independent neurologist. The DSMB found no increased risk of thrombosis or events characterised by thrombosis among the 21,583 participants receiving at least one dose of the vaccine. The specific search for CVST found no events in this trial.

Ann Falsey, Professor of Medicine, University of Rochester School of Medicine, US, and co-lead Principal Investigator for the trial, said: “These findings reconfirm previous results observed in AZD1222 trials across all adult populations but it’s exciting to see similar efficacy results in people over 65 for the first time. This analysis validates the AstraZeneca COVID-19 vaccine as a much-needed additional vaccination option, offering confidence that adults of all ages can benefit from protection against the virus.”

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “These results add to the growing body of evidence that shows this vaccine is well tolerated and highly effective against all severities of COVID-19 and across all age groups. We are confident this vaccine can play an important role in protecting millions of people worldwide against this lethal virus. We are preparing to submit these findings to the US Food and Drug Administration and for the rollout of millions of doses across America should the vaccine be granted US Emergency Use Authorization [EUA”].”

Typically these trial result announcements have been made a week or two submission of the EUA application to the FDA and then the FDA takes two to three weeks to approve the application. Consequently, it appears that a fourth COVID-19 vaccine will be online in mid-to-late April.

CAVEAT: Bloomberg reports Tuesday morning that

AstraZeneca Plc may have released outdated information about its Covid-19 vaccine trial, giving an “incomplete” view of the efficacy of the shot, said the leading U.S. agency on infectious diseases.

The Data and Safety Monitoring Board, charged with ensuring the safety and accuracy of AstraZeneca’s vaccine trial, has expressed concerns to the National Institute for Allergy and Infectious Diseases that the information released about the testing results included outdated information.

This “may have provided an incomplete view of the efficacy data,” the agency said in a statement early Tuesday, without elaborating.

“We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible,” said the group headed by Anthony Fauci, the top U.S. infectious disease official.

Astra Zeneca needs this news like it needed a hole in the head as one of the FEHBlog’s grandmothers would say.

The Centers for Disease Control offers guidance on how to talk about COVID-19 vaccines with friends and family. The FEHBlog’s general advice is simply get it. The key consideration is that all three available vaccines as well as the Astra Zeneca vaccine have 100% efficacy on preventing severe hospitalization or death from COVID-19.

The Hill reports that the Senate confirmed by a 68-29 vote the President’s nomination of Boston Mayor Marty Walsh to be Secretary of Labor. This is an important position with respect to the Affordable Care Act and ERISA as well as labor affairs.

EHR Intelligence discusses the growing role of state run health information exchanges in achieving health information interoperability.

The CMS interoperability rule addresses admission, discharge, and transfer (ADT) notifications. Providers need to fulfill a CMS condition of participation that will require all healthcare facilities to send outbound event notifications by May 2021.

All healthcare facilities must send direct electronic notifications to a patient’s provider once the patient is admitted, discharged, or transferred from another facility.

Health information exchanges are in a prime position to help prepare their clients accordingly.

This is a nifty idea, but why not give electronic notice to the health plan too?

In its latest call letter for FEHB carrier benefit and rate proposals, OPM encouraged carriers to pay attention to controlling low value care. Health Payer Intelligence discusses a relevant JAMA Open Network study finding that “there are at least 13 areas of low-value care in which Medicare Advantage and Medicare alike are not reducing healthcare spending,” among them, “antibiotics for acute upper respiratory infection, antibiotics for influenza, anxiolytic, sedative, or hypnotic medication, benzodiazepine for depression, an opioid for headache, an opioid for back pain, nonsteroidal anti-inflammatory drug (NSAID) for hypertension, heart failure, or kidney disease, radiograph for back pain, and MRI or CT for back pain or for headaches.”

From the healthcare innovation front —

  • Health IT Analytics informs us that “Statistical suicide risk prediction models could be implemented cost-effectively in healthcare organizations and may help save many lives each year, according to a study published in JAMA Psychiatry.”
  • mHealth Intelligence reports that “Researchers at the University of Cincinnati are developing a small drone, that, equipped with telehealth tools, can enter a house to facilitate virtual visits, drop off or pick up supplies, even survey living conditions.”

From the “Big Bowl of Wrong” front, the Wall Street Journal reports that “Hospitals that have published their previously confidential prices to comply with a new federal rule have also blocked that information from web searches with special coding embedded on their websites, according to a Wall Street Journal examination.” Yet, nn the bright side “After the Journal approached hospitals about its findings, the search-blocking code was removed from sites including those of HCA, Penn Medicine and Beaumont, and of South Dakota-based Avera Health, Tennessee-based Ballad Health, Maine’s Northern Light Health and Gundersen Health System in Wisconsin.” Good job Journal.

Weekend update

David Ermer–Congress, COVID-19, COVID-19 vaccine, Electronic health records, U.S. Healthcare–
Photo by JOSHUA COLEMAN on Unsplash

Both Houses of Congress are engaged in committee and floor business this coming week. The Senate is focused on confirming the President’s cabinet nominations.

Politico reports

As Senate Majority Leader Chuck Schumer and Senate Minority Leader Mitch McConnell negotiate a power sharing agreement for a 50-50 Senate, committee assignments are still up in the air. That means that Republicans like [Sen. Ron] Johnson [R Wisc] are, for now, holding hearings and markups for President Joe Biden’s Cabinet nominees, even though Democrats are in charge of the Senate floor. 

Johnson, who will eventually hand over the top GOP slot to Sen. Rob Portman (R-Ohio), said that his committee will hold a meeting next week on Biden’s pick to lead the Department of Homeland Security, Alejandro Mayorkas. Mayorkas is facing resistance from Republicans and could be stuck in committee if he doesn’t receive enough GOP support.

The Hill reports that President Biden has released a topical daily schedule for the coming week which is full of new Executive Orders. January 28 will be Healthcare Day:

Biden on Thursday will take the highly anticipated action among pro-choice advocates of rescinding the so-called Mexico City policy, which bans the use of U.S. funding for foreign organizations that provide or promote abortions.

The policy, described as a “global gag rule” by reproductive health advocates, was first instated by then-President Reagan, and has been repeatedly rescinded by Democratic presidents and reinstated by Republican presidents in the years since.

Biden will also order a review of the Trump administration’s controversial changes to the Title X family planning program, which required family planning providers participating in the program to stop providing or promoting abortions to remain eligible for funding. 

The president is also slated to sign an executive order aimed at strengthening Medicaid and initiating an open enrollment period under the Affordable Care Act.

Fierce Healthcare reports that “Micky Tripathi, Ph.D., a recognized name in the health tech world, has been tapped as the new national coordinator for health IT under President Joe Biden’s administration. * * * Tripathi will replace the outgoing Don Rucker, M.D., who held the position since April 2017. The Office of the National Coordinator for Health Information Technology (ONC) provides counsel for the development and implementation of a national health information technology framework. * * * An expert on interoperability, privacy, and technology standards, Tripathi most recently served as chief strategy officer at Arcadia Analytics, a population health management solutions company. 

On the COVID-19 vaccination front:

  • The Wall Street Journal offers a very informative article with advice from doctors about what to expect when you have an appointment to receive the COVID-19 vaccine. This is understandably of the Journal’s top five articles.
  • America’s Health Insurance Plans has created a robust website about the COVID-19 vaccines.
  • According to the CDC’s Vaccinations data website, over 4.3 million doses of COVID-19 vaccines were administered in the U.S. on Friday and Saturday.

On the reports front —