DM Studdert, MA Hall. NEJM 2022; 387: 1533-1537. Medical Malpractice Law — Doctrine and Dynamic
This article reviews the topic of malpractice and the hurdles for plaintiffs to establish liability. Some of the interesting points:
“Patients lose about 80% of medical malpractice trials.3 However, fewer than 1 in 20 claims end in courtroom verdicts; about one third are settled out of court with a payment to the patient, and the remainder are dropped or dismissed.3“
“NPDB data reveal a remarkable phenomenon: the number of paid claims against physicians has decreased by 75% in the past 20 years.” The potential reasons include tort reform, greater openness about medical errors may have reduced patients’ inclination to sue, better medical care (no evidence of this), and incomplete NPDB data. With regard to incomplete data, this can occur with “corporate shielding” in which institutions assume liability and payment responsibility in claims against physicians, thus averting reporting requirements).
Drugmakers are able to extend the patents on their drugs, keeping generics off the market, through a process known as “evergreening”… The excessive use of the patent system — by drugmakers Bristol-Myers Squibb, AbbVie, Regeneron and Bayer — keeps the prices of the medications at exorbitant levels, often at the expense of American consumers, according to the report from the Initiative for Medicines, Access & Knowledge, or I-MAK, a nonprofit organization that advocates drug patent reform.
“They get the power, they get the monopoly and they start hiking their prices,” said Priti Krishtel, a health justice lawyer and a co-founder of I-MAK…
The U.S. patent system is meant to reward innovation by permitting drug companies to sell new medications on the market and barring other manufacturers from making generic versions for a set period of time — usually 20 years. Once the patent expires, generics are allowed on the market, often at a lower list price than the brand-name drug.
But drugmakers often extend their patents by making small tweaks to the drugs, sustaining their monopolies for several years...
Humira, a rheumatoid arthritis drug from the Chicago-based biotech firm AbbVie, generated $17.3 billion in annual sales in 2021. There are 311 patent applications for the drug, 94% of which were sought after FDA approval. AbbVie’s original patent on the drug expired in 2016, but it won’t face competition until 2023...
The practice of extending patents doesn’t always go unchallenged. In some cases, generic manufacturers sue the drugmakers to get their drugs on the market, Lemley said. However, he added, those lawsuits often end in settlements between the companies.
My take: As bioethicist Arthur Caplan states, this is an unethical practice and “we need to be rethinking the rules of patenting.” There is no good reason why patients in the U.S. need to be paying 5 times as much for adalimumab as patients in Europe.
During the pandemic, several of the pharmaceutical companies have helped improve the reputation of the industry by expeditiously developing life-saving therapies and vaccines. At the same time, many have continued with outrageous price increases of generic medications. An example of this is rectal indomethacin which is used for the prevention of pancreatitis after ERCP. In this commentary, the key points:
The current price in the U.S. for this previously inexpensive medication is now $429 (in 2021) (previously $17). For patients, this charge is often multiplied by hospital billing departments and is frequently NOT covered by insurance as the manufacturer has not filed a new drug application with the FDA (new indication).
The authors note that rectal diclofenac would be a suitable alternative with similar (?better) effectiveness but is currently not available in U.S.
The government could allow importation of either diclofenac or indomethacin (see Table below for costs of these medications in other countries). “If the government used the powers granted in the Medicare Modernization Act of 2003, the price gouging problem caused by rectal NSAIDs could be swiftly solved without the need for expanding the US manufacturing market.” This would drop the “price of this potentially lifesaving prophylaxis by 99.24%.”
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”)
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.
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…
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.
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.”
“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“
“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.”
“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.”
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.”
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.
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:
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.