Do Health Care Workers Need Peace Agreements?

I have not paid close attention to the movement to unionize health care workers in the U.S. As such, I learned a few things in this past weekend NY Times article: Doctors and Nurses Shouldn’t Have to Strike (online version titled “When Health Care Workers Are Protected, Patients Are, Too”)

Excerpts:

Since the pandemic began, the health care work force — the country’s largest industry by employment — has shrunk by nearly 2 percent… Now, with astronomical turnover and rising demand as patients seek care that they may have put off during the height of the pandemic, hospitals, clinics, nursing homes and home care agencies across the country lack sufficient staff members to adequately care for patients…

Most hospitals might be private companies in their formal legal identity, but the reality is that government has shaped the health care system every step of the way of its modern existence…

Unionized health care workers all over the country are fighting back against untenable conditions in the health care industry, and they are often met with harsh treatment by employers for doing so…

Peace agreements are popular with unions because they help prevent the type of devastating reprisals that drive many workers out of their jobs, but employers often refuse to accept them…

By giving weight to workers’ on-the-job needs, while eliminating strikes, labor peace policies in health care facilities benefit patients because they give workers more power to manage their work environments. They also make establishing unions easier for workers, and data suggests that unionization in health care improves patient care.

My take: In our hospital system, recent staffing shortages have forced the hospital to close a significant number of intensive care unit beds. This will inevitably lead to postponement or cancellation (often at last minute) of needed surgical procedures (that often require availability of an ICU bed). The fix for some of the ills in our hospital system is going to be difficult. Adequate staffing with highly-trained health care workers needs to be the top priority.

Another sign that helps keep folks on the designated walking areas
–this one was at the Valley of Fires State Park, NM

America’s Formula Shortages –The Bigger Picture

A recent article (The Dispatch, Scott Lincicome: America’s Infant Formula Crisis and the ‘Resiliency’ Mirage) explains that the reasons we are facing formula shortages go beyond the Abbott recall.

Excerpts:

The infant formula crisis isn’t simply another case of a one-off event causing pandemic-related supply chain pressures to boil over. Instead, U.S. policy has exacerbated the nation’s infant formula problem by depressing potential supply….all part of our government’s longstanding subsidization and protection of the politically powerful U.S. dairy industry…

[Additionally, there] are strict FDA labeling and nutritional standards that any formula producer wishing to sell here must meet….These regulatory barriers are probably well-intentioned, but that doesn’t make them any less misguided—especially for places like Europe, Canada, or New Zealand that have large dairy industries and strict food regulations

The combination of trade and regulatory barriers to imported infant formula all but ensures that our almost $2 billion U.S. market is effectively captured by a few domestic producers—despite strong demand for foreign brands. What German company, for example, is willing to spend the time and money meeting all the FDA requirements—registration, clinical trials, labeling and nutritional standards, inspections, etc.—only to then face high import taxes that make its product uncompetitive except during emergencies? The answer: almost none…

Meanwhile, Abbott is in full-on crisis mode and has turned to flying in formula produced at an FDA-registered Irish affiliate…

WIC program’s use of sole supplier contracts has created a problem specific to the current crisis because … the big FDA recall just happened to hit the very producer—Abbott—holding most of the WIC contracts. 

My take: This article explains why there is not a simple switch to flip to fix the current formula bottlenecks.

Related blog posts:

White Sands National Park, New Mexico

How Industry Manipulates Physicians For Product Promotion

As an homage to May 4th, I wanted to highlight an AAP report that reminded me of Yoda telling Luke Skywalker: “If once you start down the dark path, forever will it dominate your destiny, consume you it will, as it did Obi-Wan’s apprentice.”

DS Diekema. AAP Committee on Bioethics. Pediatrics 2022; 149: e2022056549. Open Access. Health Care Clinicians and Product Promotion by Industry.

Background:

  • “In 2016, pharmaceutical companies spent $29.9 billion on marketing, of which $20.3 billion (68%) was directed toward health care clinicians in the form of prescriber detailing ($5.6 billion), free samples ($13.5 billion), direct physician payments related to specific drugs ($979 million), and disease education ($59 million)”
  • “In 2019, 615 000 physicians received payments or investment interests worth $3.6 billion (an average of $5854 per physician recipient), and 1194 teaching hospitals accepted payments totaling $2.63 billion”
  • “Despite their own sense of invulnerability to persuasive techniques, physicians do consider other physicians to be vulnerable.125  This phenomenon is what social scientists refer to as the “bias blind spot.”147  As a general rule, individuals underestimate the degree to which they are influenced by cognitive and motivational bias and overestimate the degree to which others are influenced by the same things.147 

Key points:

“In his book, Influence: The Psychology of Persuasion, Cialdini summarizes this literature and describes 6 basic categories of effective persuasive techniques.57

  • Commitment and Consistency…Industry representatives are trained to get health care clinicians to make a verbal commitment to use their products…once the health care clinician has tried the drug on 5 patients, he or she is more likely to continue to use the drug.7 
  • Social Proof…When told that almost all of the physicians in the region are now using drug A to treat disease B, a health care clinician will be hard-pressed not to join the group”
  • Liking… Humans tend to be more responsive and receptive to individuals who are friendly, likeable, and attractive”
  • Appeals to Authority…The use of opinion leaders and experts to give lectures supporting the use of a product”
  • Scarcity…Opportunities to engage in consulting and speaking opportunities fall into this category”
  • Reciprocation…A sense of obligation to reciprocate accompanies the receipt of any favor, gift, or kindness. Gifts can take many forms and need not be valuable.”

Reciprocation Elaborated:

  • “Much cognitive activity occurs without conscious awareness, and the most effective marketing and persuasion strategies are designed to engage the subconscious aspects of decision making…Decision making appears to rely on dual systems within the brain, a socioemotional system” and the cognitive control system.
  • “The socioemotional system tends to involve rapid, automatic processing that is often reactive, intuitive, unconscious, and sensitive to social norms…Effective marketing strategies, including the use of incentives and gifts and the nurturing of relationships, are designed to engage the socioemotional decision-making areas of the brain”
  • “The cognitive control system, on the other hand, tends to be consciously controlled, reasoned, and analytic and requires more time and conscious effort”
  • “Most health care clinicians believe they cannot be bribed and that they would never trade a small gift for changing their prescribing behavior…Gifts may subtly and subconsciously affect the way the receiver of the gift evaluates the information provided by the gift giver, and these feelings of indebtedness may ultimately lead to changes in prescribing behavior”

“With regard to the receipt of gifts from the industry, the American Academy of Pediatrics (AAP) has endorsed the AMA guidelines, which do not prohibit gifts outright but offer the following basic principles for managing them:198 

  • Physicians should decline cash gifts in any amount from an entity that has a direct interest in physicians’ treatment recommendations.
  • Physicians should decline any gifts for which reciprocity is expected or implied.
  • Physicians should accept an in-kind gift for the physician’s practice only when the gift is of minimal value and will directly benefit patients, including patient education.
  • Academic institutions and residency and fellowship programs may accept special funding on behalf of trainees to support their participation in professional meetings, including educational meetings, provided the program identifies recipients based on independent institutional criteria and funds are distributed to recipients without specific attribution to sponsors”

As a final incentive,  “in late 2020, the Department of Health and Human Services Office of the Inspector General issued a special fraud alert highlighting concerns … in connection with speaker programs.” The Office of the Inspector General warned both companies and health care professionals that such arrangements may, under certain circumstances, violate antikickback statutes.”

My take (from the report): “At a minimum, health care clinicians should be cognizant of the techniques used to attempt to alter their behavior and guard against them.”

Related blog posts:

“How Can You Tell If You Have Good-Quality Health Care?”

The blog title is a quote from Avedis Donabedian, a pioneer in the study of health care quality.

L Rosenbaum. NEJM 2022; 386: 1663-1667. Reassessing Quality Assessment — The Flawed System for Fixing a Flawed System

Background -Cost: “The Centers for Medicare and Medicaid Services (CMS) spent about $1.3 billion on measure development and maintenance between 2008 and 2018.3 Hospitals’ QI investments vary with their size, but data from the National Academy of Medicine suggest that health systems each employ 50 to 100 people for $3.5 million to $12 million per year to support measurement efforts…[and] if good care is the goal, the greatest cost of all this activity may be wasted time.”

Key points:

  • It is hard to know if health care quality is improving after early successes in “reducing nosocomial infections,8,9 improving surgical outcomes,10 and improving processes of care for patients with pneumonia, heart failure, or myocardial infarction.”
  • One study found only 37% of CMS’s Merit-Based Incentive Payment System for internal medicine were valid.
  • “Once a measure is implemented and tied to a financial incentive, an entire industry arises to boost organizations’ scores on that measure… a tremendous amount of resources are directed toward the appearance of quality rather than its substance… QI has become more a box-checking exercise for billing purposes than a meaningful act to improve care.”
  • Even if QI measures are important, there has not been adequate “consideration of whether the movement’s costs are justified by its benefits.”
  • Lost in the grumbling: “doctors want the best care for their patients.” However, there are considerable documentation burdens tied to demonstrating quality.
  • “Using internal performance standards to motivate better care — which many physicians embrace — differs starkly from using external financial incentives to improve quality.”
  • Quality metrics remain hampered by faulty risk adjustment.

Paradoxical Effects of Quality Improvement Efforts

  • Since ” better-resourced hospitals can afford administrative support to optimize billing, value-based payment initiatives can also worsen inequities…after implementation of CMS’s value-based purchasing programs, safety-net hospitals disproportionately bore the brunt of financial penalties…Billions of dollars are thus being transferred from poorly resourced hospitals or those serving the sickest patients to well-resourced hospitals, worsening the disparities we claim to be trying to fix.”
  • Also, there is “the broader irony of attempting to reduce spending with programs that create untold administrative costs and possibly greater net costs to the system long term. For instance, smaller practices that are unable to afford these administrative costs are increasingly being bought by larger health systems that sometimes charge higher prices.”

My take: It is worthwhile to try to improve quality and value in healthcare, but, not surprisingly, quite difficult to achieve. Unintended associated consequences of current efforts include an epidemic of burnout and workforce demoralization.

Related blog posts:

White Sands National Park, New Mexico


The Consequences of Prior Authorizations

Like many clinicians, I would very much like to tell insurance companies how I really feel about their prior authorization policies, and peer-to-peer processes to get approvals needed for treating our patients.

Most of the time I resent the imposition on my time to craft detailed letters explaining my rationale for treatment. Some obstructionist tactics are particularly aggravating. For example, when I am asked to do a peer-to-peer call and find out on the call that the person on the other end is neither a peer (often a pharmacist) and more importantly that this person is not authorized to remedy the situation but only to arrange another call. Another tactic of asking me to write multiple letters at different stages of the authorization process is extremely annoying. All told, these authorization requests are becoming more frequent and further impinging on my free time.

Now it turns out a study has shown the harmful effects of these maneuvers for our patients:

Constant BD, de Zoeten EF, Stahl MG, et al. Delays Related to Prior Authorization in Inflammatory Bowel Disease. Pediatrics. 2022;149(3):e2021052501 (Thanks to Ben Gold for this reference)

In this retrospective study of 190 pediatric patients ((median age 14.5 years) with IBD initiating biologics at a tertiary care hospital, key findings:

  • Prior authorization and complicated prior authorizations (requiring appeal, step therapy, or peer-to-peer review) were associated with 10.2-day (95% confidence interval [CI] 8.2 to 12.3) and 24.6-day (95% CI 16.4 to 32.8) increases in biologic initiation time, respectively.
  • Prior authorizations increased the likelihood of IBD-related healthcare utilization within 180 days by 12.9% (95% CI 2.5 to 23.4) and corticosteroid dependence at 90 days by 14.1% (95% CI 3.3 to 24.8). 

In their discussion, the authors note that “in a recent survey conducted by the American
Medical Association, 94% of physicians reported that prior authorizations delay access to
necessary care, 90% perceived a negative impact on clinical outcomes, and 30% reported that a prior authorization led to a serious adverse event for a patient in their care.”

My take: Prior authorization policies usually delay needed care unnecessarily and lead to complications in children with IBD.

Related blog posts: 

“Show Me the Money:” GI/Liver Expenditures Update

AF Peery et al. Gastroenterol 2022: 162: 621-644. Burden and Cost of Gastrointestinal, Liver, and Pancreatic Diseases in the United States: Update 2021

Using several national surveys (2016-2018), the authors provide data on GI diagnoses and expenditures for adults and children

Key findings:

  • Gastrointestinal health care expenditures totaled $119.6 billion in 2018.
  • Annually, there were more than 36.8 million ambulatory visits for gastrointestinal symptoms and 43.4 million ambulatory visits with a primary gastrointestinal diagnosis
  • A total of 22.2 million gastrointestinal endoscopies were performed, and 284,844 new gastrointestinal cancers were diagnosed
  • Gastrointestinal diseases and cancers caused 255,407 deaths

This article is loaded with statistical details

  • Abdominal pain, reflux, and constipation are the leading GI diagnoses
  • GI bleeding, cholelithiasis, pancreatitis and liver disease are the most common diagnoses associated with admission to the hospital
  • In the pediatric age group, appendicitis, intestinal infection and inflammatory bowel disease are the principal diagnosis associated with GI admissions
  • Trends in GI cancer frequency over the last three decades are shown (including ethnicity)
  • Among non-malignancy, alcohol-associated liver disease followed by cirrhosis and GI bleeding were most common causes of death in GI/Liver categories
  • Data on the frequency of colonoscopies and transplants is provided

Insurance and Medicine: Underinsurance of Children and Medicaid Coverage of DAAs

J Yu et al. Pediatrics: 2022 Jan 1;149(1):e2021050353. doi: 10.1542/peds.2021-050353. Open Access: Underinsurance Among Children in the United States

Methods: Secondary analysis of US children in the National Survey of Children’s Health combined 2016–2019 dataset who had continuous and adequate health insurance

Key findings:

  • The proportion of US children experiencing underinsurance rose from 30.6% to 34.0% (+3.4%; 95% CI, +1.9% to +4.9%), an additional 2.4 million children
  • The estimate of children lacking continuous insurance coverage rose from 8.1% to 8.7%

My take: The U.S. healthcare system is messed up. Economic incentives nudge/force families to neglect high value care frequently (& getting worse). At the same, the U.S. expends a ton of resources on low value care.

NA Wahid et al. Liver Transplantation 2021; 27: 1723-1732. Medicaid Expansion Association With End-Stage Liver Disease Mortality Depends on Leniency of Medicaid Hepatitis C Virus Coverage

Key finding:  Improvements in ESLD mortality and LDRs (listing-to-death ratios) were associated with both Medicaid expansion and leniency of HCV coverage under Medicaid. In patients living in states with nonexpansion/restrictive cohort, deaths continued to increase throughout study period.

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Patient T-shirts:

Insulin: “Poster Child For Everything That’s Wrong” with U.S Drug Costs

Fortune Dec 2021-Jan 2022: Insulin’s Deadly Cost Thanks to Stan Cohen for sharing article.

Some excerpts/key points:

  • “Insulin in the U.S. costs on average some 800% more than in other developed economies. And yes, people die for lack of it, sometimes within days or even hours of missing their dose. No one knows how many; data suggests that in the U.S. it’s at least a few every day. Far more may suffer other ravages of diabetes—blindness, heart attacks, loss of limbs.” In addition, 40% of Americans who have died from COVID-19 were diabetics.
  • “Manufacturer’s compete not by cutting prices but by raising them.” This is often due to pharmacy benefit managers (PBMs), the middleman between manufacturer’s and insurers. PBMs negotiate drug prices and establish formularies. PBMs make more money if they able to discount higher rebates on the list cost; hence, to influence PBMs to choose their products, manufacturer’s are incentivized to raise drug costs, even if the average price is unchanged. Higher list prices affect those least able to cover the costs, namely those without insurance as well as many with high deductibles.
  • List price for Humalog (Eli Lilly) more than doubled from 2013 to 2018, Lantus (Sanofi) more than quadrupled from 2005 to 2016
  • Some patients have obtained insulin in Canada where costs for a vial could be more than 10-fold less (though this is illegal). There are also more than 12,000 GoFundMe.com listings with “insulin” in the title.
  • For the insulin market, some recent changes include the emergence of GLP-1 analogs for Type 2 diabetes (~90% of diabetes in U.S.). Trulicity is now Eli Lilly’s bestselling medication. In addition, the FDA recently approved Semglee, an interchangeable biosimilar for Lantus which is reducing costs.

My take: “The story of insulin is a poster child for everything that’s wrong with a free-market approach to drug availability,” says Arthur Caplan…”It’s almost inexcusable morally.”

Related blog posts:

Is An Unproven Medication Worth More Than the EPA or NASA?

For those who have not followed the FDA’s controversial decision of approving Aducanumab for the treatment of Alzheimer’s disease, the NEJM has two useful commentaries:

Key points -from 1st article:

  • “Biogen…has announced a list price of $56,000 –10 times the evidence-based benchmark recommended by the independent Institute for Clinical and Economic Review…if even 10% of U.S. patients with Alzheimer’s disease were prescribed aducanumab, drug spending for Medicare Part B would increase from $37 billion to $69 billion per year”
  • The authors note that Medicare Part B payments rely on average sales price (ASP) from private insurers rather than a direct negotiated price; thus, the higher the price for private plans (even if poorly covered), the higher the Medicare rate
  • Hospitals and physicians are incentivized at higher prices due to receiving a 4-6% reimbursement price over the acquisition price
  • “The $56,000 price for aducanumab is a rational manufacturer response to an irrational insurance system.”

Key points -from 2nd article:

  • By one estimate, the potential cost will exceed the budgets of agencies such as EPA or NASA
  • “In granting accelerated approval to aducanumab, the FDA concluded that the drug’s ability to reduce amyloid plaques was reasonably likely to translate into clinical benefits. But this claim is hotly contested and was not presented to the FDA’s advisory committee, which voted against recommending approval of the drug because of the lack of a demonstrated clinical benefit”
  • If Medicare refuses to cover medication, this would leave a burden to state budgets. “As a legal matter,…state Medicaid programs are required to cover nearly all FDA-approved drugs.”
  • “Congress could adopt new legislation specifying that state Medicaid programs need not cover aducanumab…Protecting state budgets shouldn’t require Medicare to cover an expensive drug with unproven clinical benefits.”

My take: This type of huge fiscal burden may provide the rationale for Medicare and Medicaid to reexamine whether/how they cover expensive FDA-approved medications.

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Heroes, Villains and ‘Perverse’ Incentives. Story of Big Hospitals vs. Big Pharma


A recent article in Fortune (April/May 2021, pg 94, Big Hospitals vs. Big Pharma: Which industry is most to blame for soaring health care costs?) provides a lot of insight into the costly, complex U.S. healthcare system. Thanks to Stan Cohen for the article.

Key points:

  • U.S. spent 17.7% of GDP on healthcare expenditures in 2019, comparable OECD country averages were 10.7%
  • U.S. per capita costs were $10,966; next closest were Switzerland at $7732 and Germany at $6646
  • Despite are higher costs, U.S. has highest age-adjusted mortality rates (compared to these countries) and higher pregnancy-related deaths.
  • The U.S. has the highest rates of obesity among these countries; however, other countries smoke more and drink more
  • The biggest part of healthcare costs is from hospital care at 33%; medication costs account for ~10% but play a role in hospital costs.
  • The article makes the point that some high-priced medications, including the $2.1 million dollar Zolgensma, are worth it and others are overpriced
  • Recently both the hospitals and pharma have had good press with heroes like frontline healthcare workers and vaccine scientists. Recent villains include Martin Shkreli for excessive price hiking. However, most people are “just businesspeople responding rationally to the incentives they face.”
  • Medical costs for pharmaceuticals are complicated by an ‘insanely complex’ drug distribution system with hidden incentives and rebates. In many situations, “patients can’t get access to the better or more affordable drug because there’s some rebate happening behind the scenes”
  • In the U.S. “a majority of people are almost entirely separated from the market mechanism…Out-of-pocket spending is only 13% of total health care expenditures… most people have little incentive to shop carefully. Economically, the real consumer, the patient, is a bit player in this drama.”

My take: Improving the healthcare system is a great challenge. “It’s a lot harder than placing blame.”

Related blog posts:

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