Skip to main content
The Keckley Report

Non-Adherence to Covid-19 Vaccines: The Biggest Challenge in the Coronavirus War

By November 23, 2020March 1st, 2023No Comments

Last week, Moderna joined Pfizer in announcing promising results of their messenger RNA vaccines and their intent to file for emergency use authorization with the FDA within days. A third vaccine by Astra Zeneca-Oxford University, significant because it is a viral vector vaccine, is not far behind. And Saturday, a second drug by Regeneron received FDA emergency use approval on the heels of Eli Lilly’s approval earlier this month. That’s encouraging.

Arguably, Operation Warp Speed is a resounding success: the investment of $10.75 billion in vaccine development (Pfizer- BioNTech $1.95 billion, Moderna $2.5 billion, J&J $1.5 billion, Astra Zeneca $1.2 billion, Sanofi with GSK $2 billion, and Novavax $1.6 billion) brings hope for a return to normalcy next year. But the pandemic fatigue has taken its toll: last week, positive tests hit 12.1 million, hospitalizations soared to 84,000 and deaths hit 257,000. Hospitals in 25 states reported staff shortages and lawmakers in DC are gridlocked over a fifth relief package for small businesses and individuals. That’s where we are today.

In recent days, public health officials have taken to the airwaves to encourage American’s to forego Thanksgiving gatherings to slow the second surge. It follows their appeals since March encouraging social distancing, masking, and frequent hand washing. But for a sizeable portion of the population, those appeals have fallen on deaf ears. Sunday, airlines reported a surprising resurgence of travelers: more than 1 million. While state masking mandates are in place in 37 states, adherence * varies widely, especially in states where voters think masking and social distancing mandates are intrusive violations of their individual rights.

Non-adherence to the covid-19 vaccine will be its undoing. It’s plausible. 60% of patients do not take medications as directed. Fewer than 15% modify their diets as directed by their providers. Last year, only 62% of children and 45% of adults received the flu vaccine, so the availability of Covid-19 vaccines next year is not guarantee of the pandemic’s end. Only 6 in 10 American’s say they are “somewhat/very likely” to get a Covid-19 vaccine if doing so “would lower the risk of becoming infected by about half.” But 4 in 10 are unlikely and public health officials think at least 70% or more of the population must be vaccinated to safely return to pre-Covid ‘life as usual.’


Non-adherence is a complex challenge for the health system, even for a public health challenge like the coronavirus that’s killed a million worldwide and evokes widespread fear. In the U.S., it’s complicated by the inadequacy of funding for our public health programs: we spend less than 3% of our total federal spending on public health and 5% on primary care—well below 12-16% invested in other developed systems of the world that spend less and get better outcomes. To date, the federal government has provided $200 million to state and local agencies, far short of the $6 billion that the U.S. Centers for Disease Control and Prevention thinks necessary for a robust vaccination campaign.

Effective education of health professionals, teachers, community leaders and consumers is necessary. Widespread access to self-care diagnostic technologies for contact tracing, symptom monitoring and social distancing is vital. And the development of a “single source of truth” for evidence supporting coronavirus vaccines, therapies and interventions is imperative. The proliferation of disinformation about the coronavirus is a major deterrent to its containment and eradication.

Operation Warp Speed has effectively accelerated the development of vaccines for the coronavirus, but its ultimate success will be determined by the level of adherence achieved next year. And that’s not a slam dunk!


Just another reminder to register for the free upcoming webinar on 12/1. Hope you can join us!



Hugtenburg JG, Timmers L, Elders PJ, Vervloet M, van Dijk L. “Definitions, variants, and causes of nonadherence with medication: a challenge for tailored interventions.” Patient Prefer Adherence.

Peter Loftis, Jared Hopkins, Bojan Pancevski “Covid Vaccines Usher In New Way To Fight Disease” November 18, 2020; The Wall Street Journal

Stirratt MJ, Curtis JR, Danila MI, Hansen R, Miller MJ, Gakumo CA. “Advancing the Science and Practice of Medication Adherence.”; Journal of General Internal Medicine

Neumann et al Consideration Of Value-Based Pricing For “Treatments And Vaccines Is Important, Even In The COVID-19 Pandemic”; November 19, 2020; Health Affairs

George Halvorson, Stephen M. Shortell, Laurence Kotlikoff , Elizabeth Mitchell , Richard M. Scheffler , John Toussaint, Peter A. Wadsworth , Gail R. Wilensky “’Better Care Plan’: A Public Option Choice” November 16, 2020; Health Affairs

“Americans want high-risk people to get a coronavirus vaccine first”; Survey of 1399 adults August 14-16, 2020; The Harris Poll

“Health Literacy Needs a Fresh Look”; September 14, 2020; The Keckley Report

“Misinformation in Healthcare: It’s a Big Deal”; December 3, 2018; The Keckley Report


Health services researchers discriminate between compliance and adherence:

  • Compliance is associated with the extent to which a patient follows a health care provider’s instructions. It mirrors a parent-child relationship between providers and patients.

  • By contrast, adherence implies a more active, voluntary, and collaborative involvement of patients in a mutually acceptable course of behavior. It’s a shared decision-making model. It presumes patients (consumers) play a key role as active decision-makers in caring for themselves. It also recognizes that some choose care paths contrary to what their providers recommend, or neglect care due to their finances or fears about complications.


Vaccine, Drug Update

  • Pfizer and Moderna are filing for Emergency Use Authorization by the FDA for their messenger RNA vaccines with limited access for frontline healthcare workers and at-risk patient populations by late December.

  • Regeneron’s drug was approved for emergency use Saturday—the second antigen drug approved (Eli Lilly received approval earlier this month).

  • Tuesday, the U.S. Food and Drug Administration cleared the first Covid-19 test that people can take at home by themselves and get results without the help of a lab–the single-use, disposable test from Lucira Health Inc. that uses nasal swabs and can be self-administered by anyone with a doctor’s prescription ages 14 years or older. Results are available in 30 minutes.

The Covid Tracking Project

Study: Mandatory Masking Reduces Infections

This study analyzed evidence from a natural experiment on the effects of state government mandates for face mask use in public issued by 15 states plus Washington, D.C., between April 8 and May 15, 2020. Key Finding:
Mandating face mask use in public is associated with a decline in the daily COVID-19 growth rate by 0.9% in 1 to 5 days, 1.1% in 6 to 10 days, 1.4% in 11 to 15 days, 1.7% in 16 to 20 days, and 2.0% in 21 or more days. . Estimates suggest that as a result of the implementation of these mandates, more than 200,000 COVID-19 cases were averted by May 22, 2020. “The findings suggest that requiring face mask use in public could help in mitigating the spread of COVID-19.”

Wei Lyu, George Wehby “Community Use Of Face Masks And COVID-19: Evidence From A Natural Experiment Of State Mandates In The US”; June 16, 2020; Health Affairs

CDC: Overdose Deaths Spike During Pandemic

An estimated 19,416 individuals died of a drug overdose in the United States in the first 3 months of 2020 compared with 16,682 in the same 3-month period in 2019, according to the US Centers for Disease Control and Prevention’s (CDC’s) National Center for Health Statistics. The agency also estimates that 75,500 overdose deaths occurred in the 12-month period between March 2019 and March 2020, an increase of approximately 10%.

13% of respondents said in late June that they had started or increased substance use to cope with pandemic-related stress or emotions. Groups that were more likely to do so included young adults (nearly a quarter of those aged 18 to 24 years), Hispanic (21.9%) and Black (18.4%) respondents, essential workers (24.7%), and unpaid caregivers for adults (32.9%).

Joan Stephenson “Drug Overdose Deaths Head Toward Record Number in 2020, CDC Warns”; October 20, 2020; JAMA Network


Notable Final Rules Issued Friday by HHS, CMS to Beat Inauguration Deadline for Biden Administration

  • Stark final rule: The final rule provides exceptions to the law for certain value-based compensation arrangements between or among physicians, other providers and suppliers. It has a new exception for donations of cybersecurity technology and services and amends the existing exception for EHR items and services. The modifications take effect Jan. 19.

  • Drug rebate: Friday, HHS submitted a final rule to the White House budget office that would prohibit pharmacy benefit managers from retaining rebates paid by drug makers based on a July Executive Order by President Trump. If the administration releases a final rule, it could go into effect in 60 days. The effect of the rule would likely be higher premiums for Part D drug costs for most seniors but lower for those who use drugs with high rebates.

  • Part B drug prices: The Center for Medicare and Medicare Innovation announced a new mandatory model that changes providers’ payment for administering Part B outpatient drugs from a percentage of a drug’s average sales price to a flat fee tied reimbursement to prices charged in foreign countries (reference pricing). The mandate takes effect January 1, 2021 for the 50 drugs that constitute the majority of Medicare Part B spending.

“HHS Makes Stark Law and Anti-Kickback Statute Reforms to Support Coordinated, Value-Based Care”; November 20, 2020; HHS

Rachel Cohrs “Trump’s new drug-pricing plan overhauls outpatient drug pay starting Jan. 1”; November 20, 2020; Modern Healthcare

Altarum November Economic Indicators: Healthcare Spending Slowly Recovering

  • At $3.89 trillion (seasonally adjusted annual rate), national health spending in September 2020 was 1.0% higher than in September 2019.

  • The September 2020 nominal gross domestic product (GDP) was 1.1% lower than in September 2019, and the resulting health-spending share of GDP was 18.2%, and 17.6 of PGDP.

  • Overall health care prices in October 2020 are 2.1% higher than a year before, the slowest year over year growth rate of the past seven months. Annual prescription drug price growth was actually slightly negative this month at -0.4%.

  • Health care added 58,300 jobs in October. Health care has regained nearly 1 million jobs, or 63% of the 1.58 million jobs lost in March and April. The level of health employment now stands at 3.6% below pre-COVID-19 (Feb) employment.

  • The economy overall gained 638,000 jobs in October, comparable to last month, and has regained just over half (55%) of the 22.16 million jobs lost this spring. The unemployment rate fell from 7.9% to 6.9%

“November 2020 Health Sector Economic Indicators Briefs”; November 18, 2020; Altarum

Study: Hospital Charge-to-Cost Ratio Increases Faster than Overall Economy; For-Profit Hospitals Major Culprits

The study sponsored by National Nurses United is based on charge-to-cost ratio (CCR) for 2018 Medicare cost reports (MCR) for 4,203 U.S. acute-care hospitals. Findings:

  • The U.S. GDP increased 113.7% change between 1999 and 2018 while the nation’s health spending increased 185.6%. (from $1.3 trillion to $3.7 trillion).

  • Hospital expenditures as a percentage of national health expenditures have increased from 30.8% in 1999 to 32.7% in 2018.

  • U.S. hospital profits, or net income, increased 411% from $16.3 billion in 1999 to $83.5 billion in 2018.

  • Charge-to-cost ratios increased: in 1999, the average CCR was 200.01% increasing to 417.29% in 2018.

  • For-profit hospitals have the highest CCRs averaging 671.08%–78% higher than nonprofit facilities and 143% higher than governmental or public hospitals. HCA, the biggest investor-owned system had an average charge-to-cost ratio of 1,043% in 2018– the highest in the country. For-profit operators own/ operate 95 of the 100 hospitals with the highest charge-to-cost ratios in the U.S: HCA Healthcare (53 hospitals in Top 100), Community Health Systems (18 hospitals) and Tenet (7 hospitals).

  • Only two of the lowest 100 are operated by for-profit corporations, while 60 are owned by government agencies, including 4 hospitals whose charges do not exceed their costs.

  • Of the top 100 CCR hospitals, 40 are located in Florida. Another 14 are in Texas. Eight are located in Alabama and seven in Nevada.

  • Higher charge-to-cost ratios tend to be strongly associated with higher hospital profits.

“Fleecing Patients: Hospitals Charge Patients More Than Four Times the Cost of Care”; November 2020; National Nurses United

S&P: Non-Investment Grade Debt Surges in Healthcare

Global corporate bond issuance surged to a record high in the first three quarters of 2020, exceeding full-year issuance volumes of the past two years fueling an expansion of corporate debt globally by over $1.2 trillion in 2020, reaching $21.8 trillion by Oct. 1.

  • The debt level increased by 6% in the first three quarters of 2020, in line with the growth rate for full-year 2019.

  • The level of speculative-grade debt increased by 9% year to date to 23% as new bond issuance volumes plus fallen angel downgrades contributed to the growth of this debt. Speculative-grade debt in the U.S. (including loans and revolving credit facilities in addition to bonds and notes) now exceeds $3 trillion.

  • Healthcare debt represents 5.8% of total debt: 36% is speculative grade.

“Credit Trends: State Of Play: Record Issuance Lifts Global Corporate Debt By 6%” S&P Global Ratings

Study: Disruption of Primary Care Relationships in Medicare Leads to Higher Costs

In this cohort study of 359,470 Medicare beneficiaries who visited a primary care physician from 2008 to 2017, the loss of a primary care physician was associated with decreased use of primary care; increased use of specialty, urgent, and emergency department care; and increased spending (especially for patients of physicians in solo practice:

  • During the study period, 9,491 of 90,953 PCPs (10.4%) exited Medicare.

  • The year after PCP exit, beneficiaries whose PCP exited had 18.4% fewer primary care visits and 6.2% more specialty care visits compared with beneficiaries who did not lose a PCP. Beneficiaries whose PCP exited also had 17.8% more urgent care visits, 3.1% more emergency department visits, and greater spending ($189 [95% CI, $30-$347]) per beneficiary-year after PCP exit.

Sabety et al “Changes in Health Care Use and Outcomes After Turnover in Primary Care”; November 16, 2020; JAMA Internal Medicine

Commerce Department: October Retail Sales Down

The Commerce Department said Tuesday that retail sales, rose a seasonally adjusted 0.3% in October –well below 1.6% increase in September and the smallest monthly rise in retail sales since May.
While spending on vehicles, electronics and at home-improvement stores increased last month, sales slipped in key categories such as grocery store, clothing, and restaurant spending. Online sales at Walmart and Amazon were up but overall consumer confidence slipped as voter anxiety about the election, lack of new Covid relief funding for families and small businesses took their toll.

Harriet Torry “U.S. Retail Sales Climbed at a Slower Pace in October”; Nov. 17, 2020; Wall Street Journal

Amazon Pharmacy Challenges Traditional Retail Drugstore Model

Tuesday, Inc. unveiled Amazon Pharmacy, a section of its retail website and mobile application that lets people order medication using their health insurance. Prime members who don’t use their insurance are eligible for discounts on generic and brand-name drugs on Amazon’s site or at about 50,000 participating pharmacies. Amazon’s pharmacy comes after its $753 million acquisition of PillPack, an online pharmacy known for organizing prescriptions into packets, in 2018. Amazon will display both the price when using insurance and the price without. Amazon’s Prime membership program will be the platform for building consumer use of its pharmacy program akin to its strategy to lure Prime members to its Whole Foods Markets.

“Amazon Pharmacy is live: Shoppers can now order prescriptions directly through the tech giant”; November 17, 2020; Fortune

Medicaid Expansion Associated with Greater Access to Hospital Emergency Services

The University of Pittsburgh researchers analyzed hospital-level data from the Centers for Medicare & Medicaid Services from 2007 to 2017 to US Census data for all 50 US states and the District of Columbia (32 were expansion states). Key finding:

  • States that did not expand Medicaid experienced worsened emergency access to acute care hospitals compared with states that expanded Medicaid negatively impacting the quality of care for time-sensitive conditions such as acute myocardial infarction, stroke, sepsis, and trauma.

  • If access changes in non-expansion states were the same as expansion states, an estimated 2,242 000 more persons overall and 364,000 more low-income persons would have retained access.

Wallace et al “Association Between State Medicaid Expansion and Emergency Access to Acute Care Hospitals in the United States”; November 16th, 2020; JAMA Network