And You Thought Health Insurance Was Bad

By Kim Bellard, January 28, 2021

I spend most of my time thinking about health care, but a recent The New York Times article — How the American Unemployment System Failed — by Eduardo Porter, caught my attention. I mean, when the U.S. healthcare system looks fair by comparison, you know things are bad.

Long story short: unemployment doesn’t help as many people as it should, for as much as it should, or for as long as it should.

It does kind of remind you of healthcare, doesn’t it?

The pandemic, and the associated recession, has unemployment in the news more than since the “Great Recession” of 2008 and perhaps since the Great Depression. Last spring the unemployment rate skyrocketed well past Great Recession levels, before slowly starting to subside. Still, last week almost a million people filed for unemployment benefits, reminding us that unemployment is still an issue.

Mr. Porter reports:

· “In 2019, only 27 percent of unemployed workers received any benefits, a share that has been declining over the last 20 years.

· The benefits have eroded as well, to less than one-third of prior wages, on average, about eight percentage points less than in the 1940s.”

The states range from 58% of unemployed workers in New Jersey who receive benefits to 9% — 9%! — in North Carolina. Robert Moffitt, a Johns Hopkins economics professor, told Mr. Porter: “The program was set up to have tremendous cross-state variation. This makes no sense. It creates tremendous inequities.”

As with our healthcare system, “broken” isn’t really a good description. Each is working the way they’ve been designed. Unfortunately, if you’re poor or sick, and especially if you are both, they’re not designed to help you. Not until the poor and sick start making significant campaign contributions anyway, or at least vote in larger numbers.

Many unemployed workers, of course, also lose their health insurance when they lose their jobs, since ours is a predominantly employer-based health insurance system. As many as 15 million people may have lost their employment-based coverage due to the pandemic. If they work for the right kind/size of employer, they may be eligible for COBRA coverage, but paying for it may be difficult, between loss of employer contribution, low UI benefits, and delays in receiving UI.

At least under ACA they may have coverage options, including subsidies, through the Marketplace or Medicaid, — unless they live in one of the states without Medicaid expansion.

Even in the states that have expanded Medicaid, the economic crisis has hit their tax revenue severely, while increasing the number of Medicaid enrollees, creating a double whammy. The same, of course, is happening with the money to pay unemployment benefits, causing almost half the states to ask for federal loans.

In other words, when we have the worst crises — like a pandemic — both our unemployment insurance and our health insurance systems do worst. Those are the times we rely most on the government, but our federalism system of shared federal/state responsibilities is failing the latest crisis.

Mr. Porter sees hope:

Perhaps there is an upside to the current crisis: The glaring insufficiencies of the regular unemployment system may encourage states and the federal government to undertake comprehensive changes.

Perhaps. If the pandemic continues long enough — as it might — it might force deep structural changes. So far, the various relief bills have just added more patches to our patchwork quilt approach towards UI. But if in the coming months vaccines mitigate the impact, and the economy picks up, then our typical reaction will be to commission some studies and just kick the can further down the road.

ACA made our health insurance system less patchwork, with more uniform requirements, more subsidies, less discrimination against preexisting conditions, and broader Medicaid options. The Biden Administration may, and should, further improve these. Let’s hope that it takes a hard look at how it can do something similar with unemployment insurance.

This post is an abridged version of the original posting in Medium. Please follow Kim on Medium and on Twitter (@kimbbellard)

Four Important Takes on the Key Healthcare Trends and Issues for 2021

By Clive Riddle, January 22, 2021

With the promise and peril of each new year, healthcare prognosticators weigh in on what are the significant trends and issues that lay in wait. With the stakes in 2021 seemingly like no year in recent memory, here is a capsule of items put forward from four important perspectives as we move forward in the calendar:

PwC’s Health Research Institute (HRI) annually publishes their report on top issues for the new year, which will be featured next week in the 2021 Future Care Web Summit. This year’s report: Top health industry issues of 2021: Will a shocked system emerge stronger? “examines how the healthcare industry is expected to face the uncertainty of 2021, building resilience for long-term survival by developing its own forecasting systems, reshaping business portfolios post-pandemic for financial stability and growth, and creating a more nimble, modern supply chain.” 

They find the key issues will include:

• Virtual health reshapes healthcare delivery
• Clinical trials are changing—for good
• Digital relationships can help improve the clinician experience
• Enhanced Healthcare forecasting for an uncertain 2021
• Health portfolios reshaped for growth: increased investment in and by healthcare companies
• A resilient and responsive supply chain built for long-term health
• Interoperability 2021: potential foundation to power forward a more consumer-centric healthcare system after the pandemic

The employer perspective, from the Business Group on Health, is offered in their new report: Key Insights: Health Care Trends in 2021, which cities these five trends:

• The Proliferation of Virtual Care—  More attention will be given to the evaluation of the quality, outcomes, effectiveness, patient experience and cost of virtual care options and innovations, as well as the appropriateness of virtual vs. in-person care for specific services.
• A Reimagining of Health Care Delivery— Even though employers and plans may have momentarily slowed the expansion of alternative payment and delivery models because of the pandemic, a redoubling of efforts in 2021 will drive improvements in quality and value.
• A Spotlight on Mental Health and Emotional Well-being—In 2021, novel approaches such virtual counseling and the integration of Employee Assistance Programs and mental health benefits, will place mental health on par with other medical conditions.
• Adapting to the Well-being Needs of a Changing Workforce— In 2021, employers will continue to demonstrate flexibility and support employee needs through leave, remote work and other benefits.
• Addressing Gaps in Health Equity—In 2021, the health care ecosystem, including providers, suppliers and payers, will boost efforts to examine and address health equity, while mitigating the harmful effects of social determinants of health.

A hospital perspective is offered by the American Hospital Association in their AHA Trustee piece: Top 10 Emerging Trends in Health Care for 2021: The New Normal

1. More Strategic and Agile Supply Chains
2. Coopetition as a Viable Strategy
3. Patient Consumerization
4. Personalization of Care
5. Workforce Diversity and Safety
6. Virtual Care
7. Artificial Intelligence and Automation
8. Revenue Diversification
9. Mergers and integration
10. Payer Shifts

And finally, with the pandemic further bringing behavioral health issues to the forefront, the American Psychological Association offers their report on Emerging trends for 2021:

• Healing the political divide
• Social media is increasing impact
• The fight against racism must continue
• Psychology research is front and center
• Mental health apps are gaining traction
• Psychologists’ skills are in great demand
• The national mental health crisis
• The great distance learning experiment continues
• There’s a new push to reach underserved communities
• Psychology’s involvement in policing
• Psychologists are moving up in academia
• Online therapy is here to stay
• Advocacy will help secure expanded telehealth coverage
• Employers are increasing support for mental health

Monitoring the safety and effectiveness of COVID-19 vaccines

By Dr. Seleem R. Choudhury, January 14, 2021  

Next to clean water, no single intervention has had such a dramatic effect on decreasing mortality as has the widespread introduction of vaccines (Howson, Howe, & Fineberg, 1991). The World Health Organization (WHO) describes immunization as a “key component of primary health care and an indisputable human right,” as well as “one of the best health investments money can buy” (World Health Organization, 2020). Vaccines play a critical role in the prevention and management of the outbreak of infectious diseases.  The rapid spread of COVID-19 during the months-long wait for a vaccine have highlighted their importance to public health. 

If COVID-19 were a Shakespearean play, the administration of the vaccine would ideally be the final act, and widespread adoption and effectiveness, the epilogue. However, just like Shakespeare’s Timon of Athens, this play may be also be left unfinished. According to the WHO, at least 198 COVID-19 vaccines are currently in the development pipeline, with 44 currently undergoing clinical evaluation (2020). National Institute of Allergy and Infectious Diseases Director Anthony Fauci, M.D., recently stated a date to a possible “normal” is tricky at best (McCarthy, 2020). He explains: 

“If the vaccine is reasonably if not quite effective, but not a very large proportion of the population take it, then that would really be unfortunate because it wouldn’t provide that umbrella of protection over the community so that you could feel reasonably certain that when you go to a family function, a wedding, or the like, that there’s not going to be a couple of people in there that are actually infected.”

Continued monitoring: Reasons and methods

The effectiveness of the COVID-19 vaccine to usher in a “new normal” hinges on its widespread administration. Continuous and transparent monitoring is essential to encourage the maximum number of people to choose to be vaccinated.  This article was written fully acknowledging that the SARS-CoV-2 variant exists, yet the implications of the variant remains unclear and the impact upon the vaccines remains unknown (Public Health England, 2020). 

Reasons for monitoring the vaccine

The primary reason for conducting additional vaccine effectiveness assessments is to ensure a vaccine “protects people from getting a disease under real-world conditions, outside of the strict setting of clinical trials” (National Center for Immunization and Respiratory Diseases, 2020). Numerous factors, such as how a vaccine is transported, the method of storage, or even the way patients are vaccinated, can affect a vaccine’s effectiveness in real-world situations.  

Even after administration trials of the COVID-19 vaccine, organizations will continue to monitor longer-term safety and efficacy (Cyranoski, 2020).  Teams of experts will evaluate the effectiveness of the vaccine in real-world conditions, outside of more controlled clinical environments (WHO Ad Hoc Expert Group on the Next Steps for Covid-19 Vaccine Evaluation, 2020).  Furthermore, underlying medical conditions not present in patients who participated in the clinical trials can also change the effectiveness of the vaccine in real-world use, or in groups not included or represented in clinical trials, such as children under 12, or pregnant or lactating women (National Center for Immunization and Respiratory Diseases, 2020).   

Additionally, transparent monitoring will prove essential to improve the public’s trust in the vaccine so that people will choose to vaccinate. Public trust in the storied public health institutions cited above is now deeply compromised. According to recent polls, 62% of Americans worry the U.S. Food & Drug Administration (FDA) will rush to approve vaccines without adequately assuring safety and effectiveness because of political pressure (Hamel, Kearney, Kirzinger, Lopes, Muñana, & Brodie, 2020; Miller, Ross, & Mello, 2020).  Only 25% of Americans have “a great deal” of trust in the Centers for Disease Control and Prevention (CDC), and only 21% definitely plan to get vaccinated, while 49% probably or definitely will not (Tyson, Johnson, & Funk, 2020). 

Vaccine safety is a significant concern for many, given the uncommonly rapid development and testing process, underlying suspicion about vaccines in general among segments of the population, and mistrust of the government’s pandemic response thus far (DeRoo, Pudalov, & Fu, 2020).  Efforts to provide the population with ample information addressing these reasons for apprehension should be made before and during vaccine program rollout. 

In addition to widespread misinformation about vaccines, health organizations must also contend with mistrust of vaccines borne out of the U.S.’s historical mistreatment of people of color in the spread and prevention of infectious diseases. This includes actions such as using ethnic minorities as test subjects for medical advances in the 20th century, or giving blankets laced with smallpox to indigenous peoples in Jamestown in the 1700s, to name a few examples.  In fact, some studies link mistrust of the health care system and fears of experimentation among some African American people to historical and contemporary mistreatment and disparities in care (Yancy, 2020). 

Methods for monitoring the vaccine

Clinical trial results show whether vaccines are effective.  The FDA evaluates the data from the clinical trials, as well as manufacturing information, to assess the safety and effectiveness of vaccines, then decides whether to approve a vaccine or authorize it for emergency use in the United States (National Center for Immunization and Respiratory Diseases, 2020; U.S. Food & Drug Administration, 2018). 

However, even after a vaccine is approved by the FDA and released for public use, more assessments are necessary. According to the CDC, the goal of these assessments is “to understand more about the protection a vaccine provides under real-world conditions, outside of clinical trials” (2020).  This is accomplished by comparing groups of people who do and don’t get vaccinated, and people who do and don’t contract the COVID-19 virus to assess how well COVID-19 vaccines are working to protect people compared to other protection measures (National Center for Immunization and Respiratory Diseases, 2020). 

Future implications and vaccine resistance

These vaccine monitoring activities are the norm, but they will take place on a larger scale during this pandemic. The post-licensure vaccine evaluation will be a crucial component of an evidence-based vaccine program. This should include four aspects.

1. Collecting exposure data for COVID-19 vaccines.

The data when reviewing the efficacy of the trial is thus far encouraging and builds confidence in the continued effectiveness of the vaccine. Dedicated trials will be needed to deepen our understanding of the impact of COVID-19 vaccines among different groups, specifically children, pregnant women, and black, indigenous and people of color (Hodgson, Mansatta, Mallett, Harris, Emary, & Pollard, 2020). 

Additionally, data must be collected to assess the effectiveness of a promising administration method: heterologous prime-boost vaccination. A heterologous prime-boost vaccination is a “repeated immunization regimen designed to increase and sustain vaccine-induced immune responses” involving “sequential delivery of different vaccine platforms” (Jeyanathan, Afkhami, Smaill, Miller, Lichty, & Xing, 2020). This method has proven effective with vaccines for other diseases such as hepatitis B24 and Ebola virus (Logunov, Dolzhikova, Zubkova, Tukhvatullin, Shcheblyakov, & Dzharullaeva, et al., 2020). In past studies of other coronaviruses, “prime-boost regimens using different viral vectors expressing the same recombinant antigen proved very efficient in enhancing the target antigen-specific immune responses” (Schulze, Staib, Schätzl, Ebensen, Erfle, & Guzmana, 2008).

2. Adopting specific safety signal detection and management measures.

A vaccine safety signal is “information that indicates a potential link between a vaccine and an event previously unknown or incompletely documented, that could affect health” (World Health Organization, 2020). Experts monitor this data to decide whether changes are needed in U.S. vaccine recommendations in order to ensure that the benefits continue to outweigh the risks for people who receive vaccines (National Center for Immunization and Respiratory Diseases, 2020; European Medicines Agency, 2020). 

3. Using real-world evidence (RWE) from clinical practice.

At the beginning of the pandemic, there were well documented errors made by many countries, including notable errors in the U.S. from the CDC, the Trump administration, and hospitals (New York Times, 2020; Nather, 2020; Evans & Berzon, 2020). As a nation, the U.S. was slow to respond and react to an ever-evolving situation. Real-world evidence gathered from longitudinal studies of COVID-19 patients and vaccine recipients will play a crucial role in responding to new information quickly and effectively in clinical practice. 

4. Applying exceptional transparency measures.

The combination of data and technology makes it possible to conduct near real-time analyses of healthcare trends and, for the first time, create a more robust and accurate understanding of disease and treatments (Christian & Reynolds, 2020). This data will have to be shared in its entirety, with no detail withheld or deemed unimportant. The data must be open to criticism and analysis so that trust can be allowed to grow, and fear subsides (Nature, 2020).

Summary

Dr. Seleem R. Choudhury receiving his 1st dose of Pfizer COVID vaccine.

The COVID-19 vaccine will not be able to single-handedly eliminate the virus from our lives. It will not necessarily allow us to return to the life we led before the pandemic reared its ugly head, but it has great potential to save countless lives and make a way forward into a new normal.  The key to making this a reality is continuous monitoring of the vaccine’s effectiveness and high levels of transparency to build public trust. 

Research indicates that a majority of Americans may trust scientific research findings more if data and information were publicly shared (Funk, Hefferon, Kennedy, & Johnson, 2019; Miller, Ross, & Mello, 2020). It is essential to widen public access to information about vaccine clinical trial design, conduct, and data. This exchange of information will provide the necessary transparency and ease of interpretation of data.  

Big pharma will need to be comfortable understanding the public hesitancy and be prepared to counter this reluctance with openness and a level of transparency never seen before as the stakes could not be higher: “History has shown that once public trust in vaccines has been compromised it is difficult to win back” (Nature, 2020).

Read more from Dr. Seleem Choudhury at seleemchoudhury.com  

Resources:

Christian, J.B., & Reynolds, M.W. (2020). Combatting COVID-19 With Real-World Evidence. American Journal of Managed Care.  

Cyranoski, D. (2020). Why emergency COVID-vaccine approvals pose a dilemma for scientists. Nature, 588, 18-19. 

DeRoo, S.S., Pudalov, N.J., & Fu, L.Y. (2020). Planning for a COVID-19 Vaccination Program. JAMA Network. 

European Medicines Agency (2020). COVID-19 vaccines: development, evaluation, approval and monitoring. European Medicines Agency. 

European Medicines Agency (2020). Pharmacovigilance Plan of the EU Regulatory Network for

COVID-19 Vaccines. European Medicines Agency. 

Evans, M., & Berzon, A. (2020). Why Hospitals Can’t Handle Covid Surges: They’re Flying Blind. The Wall Street Journal. 

Funk, C., Hefferon, M., Kennedy, B., & Johnson, C. (2019). 3. Americans say open access to data and independent review inspire more trust in research findings. Pew Research Center. 

Hamel, L., Kearney, A., Kirzinger, A., Lopes, L., Muñana, C., & Brodie, M. (2020). KFF Health Tracking Poll - September 2020: Top Issues in 2020 Election, The Role of Misinformation, and Views on A Potential Coronavirus Vaccine. KFF. 

Hodgson, S. H., Mansatta, K., Mallett, G., Harris, V., Emary, K. R., & Pollard, A. J. (2020). What defines an efficacious COVID-19 vaccine? A review of the challenges assessing the clinical efficacy of vaccines against SARS-CoV-2. The Lancet Infectious Diseases. 

Howson, C.P., Howe, C.J., & Fineberg, H.V., editors. Adverse Effects of Pertussis and Rubella Vaccines: A Report of the Committee to Review the Adverse Consequences of Pertussis and Rubella Vaccines. (1991). Institute of Medicine (US) Committee to Review the Adverse Consequences of Pertussis and Rubella Vaccines. National Academies Press.

McCarthy, M. (2020). Fauci and Other Experts Debate When Our COVID-19 Lives Will Return to Normal. Healthline. 

Jeyanathan, M., Afkhami, S., Smaill, F., Miller, M.S., Lichty, B.D., & Xing, Z. (2020). Immunological considerations for COVID-19 vaccine strategies. Nature Reviews Immunology, 20. 

Logunov, D.Y., Dolzhikova, I.V., Zubkova, O.V., Tukhvatullin, A.I., Shcheblyakov, D.V., & Dzharullaeva, A.S., et al. (2020). Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomised phase 1/2 studies from Russia. The Lancet, 396(10255). 

Miller, J.E., Ross, J.S., Mello, M.M. (2020). Far more transparency is needed for Covid-19 vaccine trials. Stat News. 

Nather, D. (2020). Trump's war on the public health experts. Axios. 

National Center for Immunization and Respiratory Diseases (NCIRD), Division of Viral Diseases (2020). Ensuring COVID-19 Vaccines Work. U.S. Centers for Disease Control and Prevention. 

National Center for Immunization and Respiratory Diseases (NCIRD), Division of Viral Diseases (2020). Ensuring the Safety of COVID-19 Vaccines in the United States. U.S. Centers for Disease Control and Prevention. 

Nature (2020). COVID vaccine confidence requires radical transparency. Nature, 586(8). 

New York Times (2020). The Unique U.S. Failure to Control the Virus. New York Times. 

Public Health England (2020). PHE investigating a novel strain of COVID-19. Public Health England. 

Schulze, K., Staib, C., Schätzl, H.M., Ebensen, T., Erfle, V., & Guzmana, C.A. (2008). A prime-boost vaccination protocol optimizes immune responses against the nucleocapsid protein of the SARS coronavirus. Vaccine, 26(51). 

Tyson, A., Johnson, C., & Funk, C. (2020). U.S. Public Now Divided Over Whether To Get COVID-19 Vaccine. Pew Research Center. 

U.S. Food & Drug Administration (2018). Step 3: Clinical Research. U.S. Health and Human Services.

WHO Ad Hoc Expert Group on the Next Steps for Covid-19 Vaccine Evaluation (2020). Placebo-Controlled Trials of Covid-19 Vaccines — Why We Still Need Them. New England Journal of Medicine. 

World Health Organization (2020). Draft landscape of COVID-19 candidate vaccines.  

World Health Organization (2020). Investigation of safety signals. World Health Organization. 

World Health Organization (2020). Vaccines and immunization: Overview. 

Yancy, C.W. (2020). COVID-19 and African Americans. JAMA Network.

Health Plan Companies Start New Year M&A Activity With a Bang

By Clive Riddle, January 8, 2021

The first week of the new year witnessed a flurry of merger & activity from health plan companies, highlighted by the continuing diversification trend in which many such organizations can’t really be labeled just a health plan company anymore.

UnitedHealth Group’s Optum has acquired Change Healthcare. We are told “Change Healthcare will join with OptumInsight to provide software and data analytics, technology-enabled services and research, advisory and revenue cycle management offerings.” The agreement calls for the acquisition of Change Healthcare’s common stock for $25.75 per share in cash and is expected to close in the second half of 2021.

In a statement, Andrew Witty, President of UnitedHealth Group and CEO of Optum commented “together we will help streamline and inform the vital clinical, administrative and payment processes on which health care providers and payers depend to serve patients. We’re thrilled to welcome Change Healthcare’s highly skilled team to create a better future for health care.” Neil de Crescenzo, President and CEO of Change Healthcare, who will serve as OptumInsight’s chief executive officer, added "this opportunity is about advancing connectivity and accelerating innovations and efficiencies essential to a simpler, more intelligent and adaptive health system."

Centene Corporation announced they will acquire Magellan Health for $95 per share in cash for a total enterprise value of $2.2 billion. We are told the transaction "will broaden and deepen Centene's whole health capabilities and establish a leading behavioral health platform," with the Magellan Health CEO and management to remain in leadership roles. Centene summarizes the additional benefits of the merger as including: a combined platform to deliver better health outcomes for complex populations through the integration of physical and mental health care; an important addition to Centene's Health Care Enterprises, under which Magellan Health will continue to operate independently; creation of a next generation behavioral health platform, aligned with Centene's technology strategy with additional growth opportunities in specialty care and pharmacy.

In a statement, Michael F. Neidorff, Chairman, President and Chief Executive Officer of Centene commented "This acquisition accelerates our diversification strategy and enhances our ability to build next generation capabilities in our specialty care business by leveraging our scale and investments in technology. Furthermore, we are very familiar with the range of Magellan Health's healthcare solutions as we have been one of their customers over many years.”

Molina Healthcare, Inc. announced that its acquisition of the Magellan Complete Care line of business of Magellan Health, Inc. closed on December 31, 2020. Magellan Complete Care serves approximately 200,000 members. The transaction helped clear the way for Centene's acquisition of Magellan Health.

Harvard Pilgrim Health Care and Tufts Health Plan announced their organizations have formally combined, effective January 1, 2021, having received all regulatory approvals. Tom Croswell , head of Tufts will serve as CEO for the combined organization, and Michael Carson, head of Harvard Pilgrim, will serve as President. We are told that "while Tufts Health Plan and Harvard Pilgrim Health Care are officially one organization, both heritage brands and products will remain in the market for a period of time, and the benefits, programs and services its members rely on will not change in 2021 as a result of the combination.  The new organization’s headquarters will be located in Canton, MA; move in is slated to begin in Q4 of this year.  The new organization also anticipates announcing its new name in the second quarter of 2021."

Smaller regional plans are at it as well. Physicians Health Plan of Northern Indiana  announced they acquired Core Benefits, Inc., effective December 31, 2020, to provide additional reach into the third party administration (TPA) and employee benefits market. And Bright Health announced it has signed an agreement to acquire Central Health Plan of California. Upon closing, Bright Health will serve approximately 110,000 individuals within its Medicare Advantage business.

What will the rest of January bring in the health plan M&A world, let alone the rest of 2021?