Sterilization Matters

When patients undergo surgical or other medical procedures, they hope to receive optimal care provided by experienced physicians. They are rarely concerned about proper sterilization of surgical instruments and other medical equipment as it is likely assumed that the health care facility has applied this standard precaution. Unfortunately, however, not every medical center is adequately sterilizing its equipment, yet this is a crucial element of successful medical care.

According to a report by The Center for Public Integrity, a patient who underwent a routine rotator cuff repair surgery at a Texas hospital in 2009 was readmitted weeks later due to an infection from the deadly bacteria known as P. aeruginosa.[1] An investigation conducted by the Centers for Disease Control and Prevention (CDC) and the hospital revealed that the arthroscopic shaver utilized for the surgery contained the deadly bacteria even after the sterilization process. [2] A more recent incident occurred in March of this year where a routine inspection at an oral surgeon’s office in Tulsa, Oklahoma exposed sterilization issues, including cross-contamination problems.[3] The Department of Health stated, “more than 60 former patients [of the oral surgeon] tested positive for hepatitis and HIV.”[4]

Medical device manufacturers originally sold “single-use” devices because of the demand for disposable equipment.[5] In the late 1970s, hospitals began reusing medical devices intended for or labeled as “single-use” as a cost control measure.[6] The FDA explains that “single-use” devices are to be used once or on one patient during a single procedure whereas reusable medical devices are those that can be reused to treat several patients.[7]

Contaminated reusable medical devises can lead to infections but a method known as “reprocessing” involves meticulous sterilization intended to prevent infections.[8] Reprocessing generally includes the following steps: 1) preliminary decontamination and cleaning in the area of use such as the operating room to inhibit drying of blood and other contaminants on the devises; 2) transfer of the devise to the reprocessing area where careful cleaning occurs and 3) final disinfection or sterilization to allow the devise to be reused.[9] The FDA further explains that problems arise for reprocessing when sterilization instructions by the manufacturer are “unclear, incomplete, difficult to obtain from the manufacturer, or impractical for the clinical environment.” [10] Manufacturer designs that render proper cleaning difficult in addition to scantily paid sterilization technicians are other sources of concern.[11]

There are some diseases that preclude the reuse of medical devices, specifically Creutzfeldt-Jakob Disease (CJD).[12] CJD is a neurodegenerative disorder that causes rapidly advancing dementia, deteriorating memory, drastic changes in behavior, and coordination and visual issues.[13] It is 100% fatal; patients with CJD usually die within one year of disease symptom onset.[14] CJD results when normal brain proteins are transformed into abnormal and infectious forms known as prions.[15] Infected pituitary hormones, dura mater transplants, cornea grafts, and neurosurgical instruments are some examples of materials that can transmit the disease to patients.[16] Most disinfectant and sterilization procedures do not eliminate the infected prions.[17] Importantly, although fatality normally occurs within one year of symptom onset, the disease has an incubation period of up to 50 years, it is not readily detectable until symptoms occur, and is seemingly capable of transmission to others during the incubation period.[18]

The World Health Organization (WHO) released infection control guidelines for health facilities handling patients with CJD.[19] Essentially, any reusable surgical instruments that come into contact with “high infectivity areas” including the brain, spinal cord, and eye should be disposed of and incinerated.[20] But the difficulty, of course, is knowing who is infected with this infectious fatal disease with the disturbingly long incubation period.                                                                                                              Ensuring that hospitals follow proper sterilization is integral, but technician certification is also an important aspect of the overall sterilization scheme.[21] As the director of sterilization at a healthcare facility in New York so accurately stated, “The people who do your nails, they have to take an infection control course before they can apply for a license …Yet the people who deal with lifesaving equipment, they are required to have zero education.”[22] Currently, New Jersey is the only state that makes certification mandatory for sterilization technicians.[23]

As the provision of health care becomes more transparent, patients not only have the ability to choose where to obtain services based on price and reputation of a facility, but they are also, presumably, able to learn about various quality measures. By filtering a search based on location or hospital name, the Centers for Medicare & Medicaid Services’ (CMS) Hospital Compare Website enables patients to view quality measures such as readmission, complication, and mortality rates.[24] There, patients are able to examine the facility’s rates in comparison to the national average.[25] Therefore, improper sterilization leading to increased infection rates will likely be exposed to the public, however attenuated, which could cause patients to seek care elsewhere—at least in time, among consumers able to bring choice to the equation (non-emergency, non-insurance dictated) and who have the ability to comprehend the data. But seemingly, more direct measures can be taken to ensure patient safety.

Managing Whistleblower Risk and Liability

Last week, the Jersey Journal reported that a jury recently awarded a former employee of Bayonne Medical Center over $2.1 million in his whistleblower suit against the hospital.  The employee, Ceferino Doculan, alleged that the hospital violated New Jersey’s whistleblower statute, the Conscientious Employee Protection Act (CEPA), by terminating his employment as a technician in the hospital’s blood bank because he had complained to hospital personnel that his new supervisor was not qualified to hold that position under New Jersey law.

Although the hospital argued it had terminated Doculan for other reasons, the jury apparently accepted Doculan’s view of the predominant reason for his firing.  According to the article, the jury awarded him about $120,000 in compensatory damages (lost wages and pain and suffering) and $2 million in punitive damages.  The hospital intends to appeal.

The case offers several lessons regarding whistleblower liability risks for hospitals and other healthcare providers.   One broad takeaway is that management of whistleblower risks cannot be disentangled from other compliance matters.   So, in addition to the concerns about how to respond to a whistleblower appropriately, Bayonne Hospital had an actual legal problem – the supervisor was not qualified under New Jersey law.   CEPA and most other whistleblower laws do not limit protection to complaining employees who are correct about the law; typically, the employee’s report must merely be made in good faith.    Yet, intuitively, if the employer has in fact broken the law,  the employee may have an easier time establishing her wrongful termination claim, in part because the existence of the legal violation will potentially make the whistleblower more credible in her lawsuit.  Thus, vigilance about compliance with the law in the employer’s operations in general – in this case, on a human resources-related matter – is a key component in reducing whistleblower liability risks.

Second, keep in mind that, with rare exception, whistleblower laws protect only reports of illegal conduct or conduct that poses some kind of direct and serious risk to the public.  Whistleblower laws do not protect employee reports of violations of employer policies, nonlegal disputes with the employer, or other purely internal matters.   But, in highly regulated industries like healthcare, actions that might not otherwise implicate the law often do.  For example, in most industries, the law does not require a license, special training, or other credentials to serve as a supervisor; in healthcare, things are different.   Compliance personnel in the healthcare context therefore should know that whistleblower liability risks linger in the background of many human resources and other kinds of decisions.  Employee complaints and reports regarding such decisions – even those that might seem standard or run-of-the-mill – therefore should be taken seriously and treated like those that obviously involve legal mandates.

Finally, hospitals and other healthcare providers potentially confront multiple whistleblower regimes.  High-profile whistleblower litigation in this area often involves federal law, most notably, the False Claims Act (including “qui tam” actions for alleged overbilling of the government).  See examples here and here.   And the new whistleblower provisions found in the Affordable Care Act are garnering much attention.  But, as the CEPA claim in this case suggests, many states provide statutory and common-law whistleblower protections that sweep more broadly, potentially protecting employees who report a wide variety of alleged legal violations.   Each of these federal and state regimes has its own set of legal requirements, limitations, and remedies.  A working familiarity with these various regimes can enhance compliance and risk management.

For those interested in learning more about federal and state whistleblower regimes, Seton Hall Law School now offers an eight week online course on managing whistleblower risks.  The course is designed to introduce human resources and compliance personnel to the laws protecting employees who report alleged misconduct of their employers.  If you would like more information, please visit the course website  or call 973-642-8482.

Memorial Day, Remembering our Veterans With Treatment

It is Memorial Day, and like in past years I will ask that we take a moment here to consider the sacrifices at the heart  of this holiday—we remember our fallen, we memorialize our dead. At present, the Veterans Administration is having great difficulty in treating and compensating our war wounded.

Number of Veterans Affected, Multiple Deployments

Since the U.S. went to war in Afghanistan in 2001 and Iraq in 2003, about 2.5 million service members have been deployed in the Afghanistan and Iraq wars, according to Department of Defense data. Of those, more than 800,000 were deployed more than once; 400,000 have done three or more deployments, and nearly 37,000 were deployed more than five times.[1] Obviously, multiple deployments increase the likelihood of service related injuries.

Wounded & Injured

It is worth noting that although considered the longest wars in U.S. history, Iraq and Afghanistan have produced relatively few U.S. service member deaths: 6,648 (as of March, 2013), but have produced a large number of wounded in action (roughly 50,000). According to reports such as Modern Warfare, by Alec C. Beekley, MD, FACS, LTC, MC, US Army, Harold Bohman, MD, CAPT, MC, US Navy, and Danielle Schindler, MD,[2] compared to Vietnam, the mortality rate of combat wounded in Afghanistan and Iraq has decreased by nearly half. New medical procedures, protective gear such as body armor and faster medical evacuation are saving more than 90 percent of all those who fall in battle, many of whom would have died on the battlefield just a generation ago. They live, but they are compromised substantially.

Type of Injuries

Notably, according to Modern Warfare, prior wars “had a higher proportion of thoracic injuries and fewer head and neck injuries. There has been a decreased incidence of wounds to the abdomen since the Persian Gulf War. The percentage of blast-related injuries is now higher.”

The number of injured are estimated by many to be ten and twenty times the number wounded in action.[3]

As would be expected with the dominance of “blast related injuries,” hearing loss, traumatic brain injury (TBI), PTSD and clinical depression, are leading injuries, with hearing loss first.[4] A 2005 Department of Veterans Affairs research paper found that one third of returning soldiers were referred to audiologists due to exposure to blasts, and 72% of them were identified as having hearing loss;[5] a 2013 report by the U.S. Congressional Research Service estimates that 255,330 members of the military suffer from TBI;[6] a 2008 study by the Rand Corp found that 14% of Iraq and Afghanistan Veterans screened positive for PTSD, 14% for major depression, and 19% had a probable traumatic brain injury.[7]

And notably, the VA reports that 37% of the claims it has backlogged at present are from Vietnam Veterans, a great influx of which (260,000) occurred after the VA finally expanded the number of illnesses presumed to be associated with Agent Orange.[8]

VA Backlog

The Center for Investigative Reporting recently released a report[9] (featured on NPR)[10] which found:

• Despite assurances from the Obama Administration that the VA would be streamlined, “the internal documents show the VA expects the number of veterans waiting – currently about 900,000 – to continue to increase throughout 2013 and top a million by the end of this month [March, 2013].
• The VA’s internal documents “show that the average wait time for veterans filing disability claims fell by more than a third under President George W. Bush, even as more than 320,000 Iraq and Afghanistan veterans filed disability claims.
• The documents show delays escalated only after Obama took office and have more than doubled since, as 455,000 more returning veterans filed their claims.”
• Pointedly, under President Obama “the ranks of veterans waiting more than a year for their benefits grew from 11,000 in 2009, the first year of Obama’s presidency, to 245,000 in December – an increase of more than 2,000 percent.”
• Although the VA tracks and widely publishes the avg. number of days it takes to process a claim (273 days), that number pointedly does not refer to new claims. The average number of days to process a new claim in Newark is 371.6 days[11]

That amounts to roughly a year and a week for an initial claim in Newark, New Jersey– a very long time to live for a disabled veteran without much needed payments.

And importantly, if a veteran fails to characterize the claim correctly, the appeals process can literally take 2 and 3 years.

 

Giving Patients a Piece of the Action: Appealing Proposals from Richard Frank and Christopher Robertson

In a recent edition of the New England Journal of Medicine, Richard Frank discussed recent efforts on the part of federal and state governments to enroll so-called “dual eligibles,” that is, individuals who qualify for both Medicare and Medicaid, into health plans that use “a strong care-management system under a unified budget.”  Many believe that such plans have the potential to both save the government money and provide better coordinated, higher quality health care.  (I discussed the need to better coordinate care for dually-eligible people here.)  Individual beneficiaries are not necessarily convinced, however.  Frank reports that it has been “very difficult to lure” them into “state-designed care coordination entities.”  Beneficiaries may be hesitant to leave their fee-for-service doctors and other providers; they may also be afraid of the incentive to restrict services that a capitated global payment creates.

To get beneficiaries to make the switch from fee-for-service to coordinated care, states are taking a page from Nudge and making enrollment in a coordinated care plan automatic.  The burden is then placed on the beneficiary to opt out if he or she so chooses.  The use of “passive enrollment” will no doubt “work” to increase the rolls of coordinated care plans, but Frank wants states to aim higher, to strive to “promote self-determination for vulnerable populations and offer them a reason to engage with a new care delivery system with coordinated-care arrangements[.]”

As Frank explains, “[c]oordinated care for dually eligible people is built on a financial structure known as shared savings, in which three of the parties involved –- the federal government and state governments and the [coordinated care plan] –- share any financial gains from coordinating care.”  Frank proposes that beneficiaries, too, be given a share of the expected savings– a share that they would be permitted to use to pay for “supplemental services and supports such as transportation, home modifications, and personal assistance with activities of daily living.”  The prospect of (limited) control over a share of the expected savings would serve as an incentive to beneficiaries to engage in care coordination, while also “promot[ing] self-determination and the exercise of real options.”

Frank’s very appealing idea brought to mind the proposal Christopher Robertson makes in The Split Benefit: The Painless Way to put Skin Back in the Healthcare Game, which is forthcoming in the Cornell Law Review.  While Frank would give beneficiaries an incentive to opt in to coordinated care, Robertson would give them an incentive to opt out of inefficient, high-cost care.  Specifically, Robertson proposes that when a physician “prescribes a high-cost treatment that the insurer reasonably believes is inefficient[,]” the insurer would “[p]ay a small but substantial part of the insurance benefit”—-what he terms the “split benefit”—-in cash directly to the patient beneficiary.  Then, “[i]f the patient chooses to proceed with the treatment, the patient takes the cash payment to the provider (along with any required cost share obligation), and the insurer matches it with the balance of the insurance benefit[.]”  Patients who choose not to proceed with treatment, however, could spend the cash differently, on a “treatment that is not covered by the insurer (whether it is acupuncture, an alternative diet regimen, a concierge doctor, or visiting nursing services), paying money to a member of the family to stay home and provide care to the dying patient, or purchasing disability insurance to help cope with the symptoms of the illness.”  They could even use the money to pay for non-health-related expenses.  As Robertson explains, the split benefit would save insurers (and, down the line, purchasers of insurance) money by giving beneficiaries a financial incentive to turn down high-cost, low-value treatments.  In Robertson’s words, the patient autonomy movement has been “cramped” by the fact that patients have been offered only “a walled garden of medical choices.”  His split benefit, by contrast, “embraces a value-pluralism, respecting the patient’s weighing of medical and non-medical values.”

I highly recommend both Frank’s and Robertson’s pieces to anyone who—-like me—-is interested in ways to give patients a piece of the action when it comes to the multiplicity of current efforts to coordinate and rationalize their care.

Project Shows Substantial Decrease in Colorectal Surgery Infections

There was a time in medical science when doctors did not wash their hands prior to operating on their patients (some might say, that to a greater extent than seems possible, this is still the case among medical professionals and point to a number of recent studies as uncomfortable proof). This failure of doctors to wash hands in the medical forum led to the otherwise avoidable death of many of their patients. Up until the mid 1800s, medical science had simply not made the connection between bacteria, transference, infection and death.

Ignaz Semmelweis, a Hungarian physician who was Director of the maternity clinic at the Vienna General Hospital in Austria, made the connection after what is said to have been an extensive statistical analysis in the 1840s, and demonstrated that hand-washing could drastically reduce the number of women dying during childbirth. He introduced a rigorous hand scrubbing protocol and enough women stopped dying to earn him the honorific, “savior of our mothers.”

But as an article from the UK’s Science Museum, Exploring the History of Medicine, points out

Until the late 1800s surgeons did not scrub up before surgery or even wash their hands between patients, causing infections to be transferred from one patient to another. Doctors and medical students routinely moved from dissecting corpses to examining new mothers without first washing their hands, causing death by puerperal or ‘childbed’ fever as a consequence. As dissection became more important to medical practice in the 1800s, this only increased.

Semmelweis showing again that the common sense of one era is the uncommon brilliance of one bygone.

Which brings us to this latest study/project showing new solutions which decrease the risk of colorectal surgical site infection. According to the Associated Press in an article about the project,

“Almost 2 million health care-related infections occur each year nationwide; more than 90,000 of these are fatal.”

And:

“Infections linked with colorectal surgery are particularly common because intestinal tract bacteria are so abundant.”

 

According to the press release regarding the Project,

A project to reduce colorectal surgical site infections (SSIs) saved more than $3.7 million in costs for 135 avoided SSIs. The two-and-a-half year project included seven hospitals and was directed by the Joint Commission Center for Transforming Healthcare in collaboration with the American College of Surgeons.

The participating hospitals were able to reduce superficial incisional SSIs, which affect skin and underlying tissue, by 45 percent and all types of colorectal SSIs by 32 percent. The average length of stay for hospital patients with any type of colorectal SSI decreased from an average of 15 days to 13 days. In comparison, patients with no SSIs had an average length of stay of eight days.

The press release further notes that

Colorectal surgery was identified as the focus of the project because SSIs are disproportionately higher among patients following colorectal surgeries. Colorectal surgery is a common procedure across different types of hospitals, can have significant complications, presents significant opportunities for improvement, and has high variability in performance across hospitals. The project addressed preadmission, preoperative, intraoperative, postoperative and post discharge follow-up processes for all surgical patients undergoing emergency and elective colorectal surgery, with the exception of trauma and transplant patients and patients under the age of 18. Project participants studied the potential factors that contribute to all three types of colorectal SSIs – superficial incisional, deep incisional and organ space SSIs, which affect organs and the space surrounding them.

 

The AP article:

Solutions included having patients shower with special germ-fighting soap before surgery, and having surgery teams change gowns, gloves and instruments during operations to prevent spreading germs picked up during the procedures.

Some hospitals used special wound-protecting devices on surgery openings to keep intestine germs from reaching the skin.

The average rate of infections linked with colorectal operations at the seven hospitals dropped from about 16% of patients during a 10-month phase when hospitals started adopting changes to almost 11% once all the changes had been made.

The AP article further notes the timely nature of the Project’s benefits:

Besides wanting to keep patients healthy, hospitals have a monetary incentive to prevent these infections. Medicare cuts payments to hospitals that have lots of certain health care-related infections, and those cuts are expected to increase under the new health care law.

Drug and Alcohol Addiction, Costs and Lack of Care

Interesting article in the Washington Post/ Kaiser Health News I stumbled across in our sidebar; it discusses both the cost of addiction, with emphasis given to drugs and alcohol, and the absolute dearth of doctors trained in addiction medicine.

The article states that

“Of the 985,375 practicing physicians in the United States, only about 1,200 are trained in addiction medicine….”

And notes that

A recent comprehensive report by the National Center on Addiction and Substance Abuse (CASA) at Columbia University found that most doctors fail to identify or diagnose substance abuse ‘or know what to do with patients who present with treatable symptoms.’

Which is problematic, given that the report is said to have found that “Only about 10 percent of the 22 million Americans with a drug or alcohol problem receive treatment,” “addiction [including nicotine] is linked to more than 70 diseases or conditions and accounts for a third of inpatient hospital costs. The press release from the report, “Closing the Gap between Science and Practice,” also notes that “Costs to federal, state and local governments amount to 11 percent of total spending; 95 cents of every dollar pay for the consequences and only 2 cents go to prevention and treatment.”

And rather ominously, the WaPo/Kaiser Health News article reports that “The federal Substance Abuse and Mental Health Services Administration estimates that up to a third of the 30 million Americans who may gain health insurance under the Affordable Care Act have a substance abuse or mental health problem.”

There’s some math to be done here regarding costs, and I won’t suggest that I know what percentage the total spending should be for prevention- but I’ll guess that 2% for prevention and treatment is not ideal. And the thought that “most doctors fail to identify or diagnose substance abuse ‘or know what to do with patients who present with treatable symptoms,’” is less than comforting.

But, as someone with a rather large personal stake in all this- in recovery for nearly two decades- what is somewhat comforting is that if, as the report suggests, there is a gap between the science and practice (actually, the more you look, “chasm” seems more fitting a description), a closer look at the science shows some remarkable advances in medical science’s understanding of addiction-especially as it regards the  neurobiological processes, focus on the brain’s “reward circuitry,”  neuroadaptations maintained by former drug users long after drug use has stopped, with particular attention on the mesolimbic dopamine system, and, more generally, addiction as a disease of bio-psycho-social etiology.

Armed with this knowledge and the prospect of the newly insured and afflicted making their way to emergency rooms and court houses all across America, perhaps this next decade can be about implementation- always difficult, but surely the fruit of hard won knowledge. And if you have any doubts about the actual costs of drug and alcohol addiction- tallied in lives and families ruined- or to get a sense of just how important implementation is-I would highly recommend you find your way to an Al-Anon or Nar-Anon meeting, and just listen.

Professor Frank Pasquale featured in The Record on ‘A Constitutional Right to Health Care’

Professor Frank Pasquale wrote a featured Op-ed in The Record, New Jersey’s most awarded newspaper, regarding a constitutional right to health care. Professor Pasquale, who is Associate Director of the Center for Health & Pharmaceutical Law & Policy and Editor in Chief of HRW, writes:

SHOULD the Supreme Court weigh in on America’s great health care debate? Yes. It should declare a constitutional right to health care.

This right is already enjoyed by prisoners. Law-abiding citizens deserve it, too.

The United Nations’ Universal Declaration of Human Rights states, “Everyone has the right to a standard of living adequate for the health and well-being of himself and of his family, including… medical care.”

Many advanced countries have adopted – and lived up to – similar commitments.

Of course, that’s not on the Supreme Court’s agenda. Instead, it will decide whether to cripple last year’s health reform, known as the Affordable Care Act, by declaring the individual mandate unconstitutional.

I understand objections to the mandate. Cash-strapped Americans don’t deserve one more drain on their resources. I’m also not a fan of making people buy health insurance from private insurers. They waste a lot of money, and are one reason why U.S. doctors’ administrative costs are a whopping 400 percent higher than those in Canada.

If I designed the ACA, I’d have given everyone a public option, modeled on Medicare.

But I didn’t write the bill, Congress did. In precedents going all the way back to the 1819 case of McCulloch v. Maryland (and affirmed as recently as 2010), the Supreme Court has deferred to Congress’s constitutional powers to solve national problems.

Politics

The court risks looking political if it abandons that approach now. It has already jettisoned once-venerable holdings on campaign finance, equal protection and antitrust.

Read the full Op-ed here.

What’s Worse than a Kidney Stone? or, “The Part II I had Hoped I Wouldn’t be Writing”

What’s worse than a kidney stone? For those of you who have had one, or read my post the other day describing how it felt–

…broke out in a cold sweat and quickly began writhing around and wailing in pain like a wild animal caught in a bear trap. The pain came in excruciating waves radiating as though I had just been punched below the belt– repeatedly.

that might be difficult to answer. But I’m going to go with two kidney stones– back to back, or more precisely, two kidney stones, and a tiny cyst and a 1.5 cm lesion on and in my kidney, respectively– which is my current diagnosis. An ultrasound  was unable to rule out cancer for the lesion.

And so I wait. A CT scan with contrast is next, probably sometime later this week– after a pre-cert from my insurer, Cigna– which has yet to fail me.

As you might imagine, the last week– what with the back to back kidney stones and all — was less than comfortable. But fortunately, the pain comes in waves and as the week wore on and I became more accustomed to the new and seemingly interminable rhythm, I was able to work in between the waves. And doing so brought me no small measure of joy– no longer reduced to a being defined solely by pain, I produced. I contributed. I was not merely subject to.

And so this blog.

The presence of the cyst caught me unawares. Initially diagnosed as one of two stones waiting in the wings back at the E.R., they were presented to me as nothing I’d have to worry about in the near future. Still in the kidney itself, they might have proved candidates for blasting. The follow-up trip to the urologist disabused me of this notion while apprising me that the one “stone” was a cyst which would have to be further examined so as to rule out density– which is a euphemism for cancer.

And in a moment it all changes. I got the sonogram later that day, and later that night I wrote to this blog’s Editor-in-Chief, somewhat incredulous as to how I signed things for that test– legal documents– in a haze of fear, pain and painkillers. Legally trained, I scribbled my name or initials on everything before me with what barely amounted to a perfunctory glance as I received one sentence explanations from the admittance clerk for one page fine print documents– no doubt painstakingly wrought by the pens of my legal brethren to ensure compliance– and payment. But I assure you, the compliance was a one-sided affair. Because, as our Editor-in-Chief Frank Pasquale has said so many times before, the acquisition of healthcare is fundamentally different than buying other commodities. It is not like buying a car; the economy of healthcare is unconventional– far more akin to “how much would you pay for a glass of water in the desert,” than how much of a rebate is available on that new Kia Soul. A hard bargainer, car dealers hate me. In the legal world, I’ve built a reputation as someone with a cold hard eye for a contract. In the hospital, I signed with an almost wild abandon–wondering who would take care of my children as I did.

And today I got the results. One kidney stone gone, one still making its way, and

“Tiny parapelvic cyst right kidney. This does not appear to correspond to the 1.5 cm visualized right renal lesion on CT scan. Therefore, possibility of a solid lesion not visible ultrasonographically cannot be ruled [out].”

His footsteps loud as he walked down the hall, the melodramatic stringed theme from “The Godfather” played in the room as the doctor entered and explained. Even if it is cancerous, I’m told it’s small. Maybe even too small to do anything but wait to see what it does– and test the rest of me to see if it migrated from someplace else.

But whatever this process may be, I think there might be some value in my writing about it– for both of us. No longer mired in the abstractions of healthcare, I am, it seems, walking straight into the belly of the beast. Consider this a postcard of sorts– with the hope that it can work itself into being a guide.

Recommended Reading: Recent Legal Scholarship on Decision-Making about Health and Healthcare

In Health Choices: Regulatory Design and Processing Modes of Health Decisions, Orly Lobel and On Amir briefly summarize a fascinating series of experiments they have conducted with the support of the Robert Wood Johnson Foundation that test individuals’ ability to make decisions about their health in the face of cognitive depletion or overload.  A longer version will be available in September, but the summary is well worth reading.  Lobel and Amir begin by reviewing a line of research demonstrating, perhaps unsurprisingly, that “psychological depletion caused by a prior task” — in one study it was eating radishes while resisting cookies–leads to a reduced ability to exercise “executive control” and “persist in demanding cognitive activities.”  As the authors note, applying this research to the context of health related decision-making is important because patients and providers alike are frequently asked to process information about relative risk and make reasoned, reasonable decisions under conditions of cognitive depletion or overload.

To test their hypothesis that “absent sufficient resources for executive functions individuals will take more risk in their [health-related] decisions,” Lobel and Amir conducted a lab experiment with approximately 700 participants and a web-based one with over 3000 participants, including 300 medical doctors.   The findings from their studies support the conclusion that depletion affects people’s ability to process risk, albeit not in entirely intuitive or predictable ways.  For example, when parents are cognitively depleted, they become more risk averse regarding vaccinating their children, but when policymakers are cognitively depleted, they become less risk averse regarding population-wide vaccination.  When consumers are in a state of attention and focus, a long list of potential side effects will deter them from using a new drug.  When cognitively overloaded, though, they paid “less attention to warning lists the longer they were.”  The implications of Lobel and Amir’s work are many, varied, and vast; I am looking forward to reading the full paper when it comes out in September.

I also highly recommend Christopher Tarver Robertson’s Biased Advice, which was published in the Emory Law Journal earlier this year.  Robertson conducted a series of experiments that built on the groundbreaking 2005 study by Daylian M. Cain, George Loewenstein & Don A. Moore evaluating the effect of a conflict of interest, and of disclosure of the conflict, on the quality of advice given by advisors regarding the number of coins in a jar and on the accuracy of advisees’ estimation of the number of coins in the jar.  Cain and his colleagues’ most surprising finding was that when a conflict existed, disclosing it caused the accuracy of advisees’ estimates to decline, in part because advisors gave more biased advice when their conflicts were disclosed than when they were not disclosed.

Among other questions, Robertson examined whether a more concrete disclosure about an advisor’s bias–that is, that “prior research has shown that advisors paid in this way tend to give advice that is $7.68 higher on average than the advice of advisors who are paid based on accuracy”–would aid advisees.  It did not, because advisees did not do what “one would hope and expect” and simply subtract $7.68 from the advisor’s estimate.  Rather, it appears that they “used the bias disclosure not as a mechanism of calibrating their reliance more precisely, but rather as a strengthened warning suggesting that the advice is altogether worthless.”

On the other hand, disclosing to advisees that an advisor was paid based on the accuracy of the advisee’s estimate–i.e. that the advisor’s financial interest aligned with that of the advisee–led advisees to rely more heavily on the expert’s advice and, as a result, to more accurately estimate the number of coins in the jar.  Disclosure of a conflict of interest is also likely to be valuable where advisees can seek out another advisor; a second, unconflicted, opinion dramatically increased the accuracy of advisees’ estimates.

Robertson’s research is important and interesting.  As he observes, one of the reasons that it is so difficult to rein in health care costs is that “[t]he health care industry is characterized by radically distributed decision making, with each patient deciding upon her own course of treatment within the range of treatments offered by providers and covered by public and private insurers.”  Improving individual decisions may be key to bending the cost curve.  Robertson’s research suggests that a disclosure mandate could help under certain circumstances, where, for example, there is “epistemic charlatanism” and a physician’s disclosure of a financial conflict of interest would lead a patient to reject the physician’s not-so-expert recommendations.  Robertson emphasizes, however, that disclosure does not improve layperson decision-making nearly as much as unbiased advice does.

Exploitations of Immortality

Rebecca Skloot’s remarkable book The Immortal Life of Henrietta Lacks has quite a following among health lawyers. As an excerpt from the book explains,

Henrietta Lacks was a poor Southern tobacco farmer who worked the same land as her slave ancestors, yet her cells — taken without her knowledge — became one of the most important tools in medicine. The first “immortal” human cells grown in culture, her cells — known as “HeLa cells” — are still alive today, though she has been dead for more than 60 years.

If you could pile all HeLa cells ever grown onto a scale, they’d weigh more than 50 million metric tons — as much as a hundred Empire State Buildings. HeLa cells were vital for developing the polio vaccine; uncovered secrets of cancer, viruses, and the effects of the atom bomb; helped lead to important advances like in vitro fertilization, cloning, and gene mapping; and have been bought and sold by the billions. Yet Henrietta Lacks remains virtually unknown, buried in an unmarked grave.

Skloot tells the story of the Lacks family, which never shared in the prosperity based on the HeLa cells. This is old news for any property student familiar with Moore v. Regents, but it’s particularly poignant in this context.

Now Skloot has worked to share the book’s proceeds with the Lacks family. As a recent news article explains,

Since the book’s debut a year ago, it has earned rave reviews, prizes, a movie deal with HBO and a steady spot on best-seller lists. And Ms. Skloot is making good on her pledge to share the financial windfall with the Lackses. Soon after the book came out, she created the Henrietta Lacks Foundation to help Mrs. Lacks’s descendants, some of whom suffered from the whirlwind of publicity, misinformation and scam artists surrounding HeLa cells, not to mention a lack of insurance to pay for any of the medical advances Mrs. Lacks’s cells made possible. . . .

The foundation — which is still in the process of applying for nonprofit status — is paying for a high-tech hearing aid for Mrs. Lacks’s youngest son, Zakariyya; truck repairs for her middle son, Sonny; new teeth for her granddaughter Kimberly; braces for her great-granddaughter Aiyana Rodgers; and, yes, tuition, books and fees for five of her grandchildren and great-grandchildren.

Whatever one thinks of the proper compensation for research subjects, it is disheartening to consider the economic difficulties of the Lacks family. (How can a society that spends, on average, $1425 per year on care and maintenance of its pets, not provide dental care for all?)

I think part of the answer lies in our constant striving for “innovation,” and the comparative devaluation of dissemination of innovation. My colleague Gaia Bernstein has written about these trends in several contexts. I have also worried about the lack of a US industrial policy for distributing the gains of innovation. I first came to these conclusions in the context of a paper I wrote on “immortal stem lines,” almost a decade ago. As the abstract argued:

[I]nnovations that now look benign might lead to an era of untrammeled biotechnological manipulation of our lives. For example, the same technology used to eliminate disease-causing genes or to clone embryos may eventually be deployed to produce genetically engineered children. That could, in turn, entrench class differences, since only the wealthy could afford the most desirable genetic enhancements. . . . Public debate on regenerative medicine must acknowledge this inequality. Societies and individuals can invest in it in good conscience only if they are seriously committed to extending extant medicine to all.

Without more attention to those at the bottom of the economic heap, the biotech project might recall these haunting lines from John Bunyan’s “The Pilgrim’s Progress:” “Now he had not run far from his own door, but his wife and children perceiving it, began crying after him to return, but the man put his fingers in his ears, and ran on, crying, Life! Life! eternal life.” Gary Shteyngart’s recent novel imagines a world where a company that sells modern-day “immortalization services” only takes on clients who promise to prioritize payments for the company’s “dechronificaiton” over any claims by relatives for help. They don’t even consider the possibility that those seeking endless self-preservation might be tempted to give to charity instead. Michel Houllebecq’s much worse novel, The Possibility of an Island, carries the trope further, imagining a future where the wealthy simply clone themselves into the future rather than worrying about reproducing.

In my article on immortality, I reach conclusions similar to those of Andre Gorz in The Immaterial. Whenever we come across a project that

will enable ‘us’ to free ‘ourselves’ from the contingency of our factuality. . . . to recreate and transcend ‘ourselves’ or even abolish the human condition[,] [t]his re-creation might be said the be the supreme stage of self-production. But it is a grammatical mirage. . .. [There is a] difference between the natural body and the body reprogrammed by science. . . .

In my own words, from my 2002 article:

Artificial-intelligence [based immortality] projects are unconvincing because their products lack bodies, and therefore cannot experience the sense-perceptions that are fundamental to human consciousness. Given the inevitable decay and profound importance of the brain, perpetual rounds of organ replacement seem only to offer their beneficiaries a series of lives, and not really a chance to maintain a coherent one. Neither the inorganic nor the organic forms of immortality offered by these two families of technologies offers indefinite life that is recognizably human or continuous with that of the person who employs them.

Nevertheless, I expect the “immortality project” will continue to attract followers. John Gray’s book “The Immortalization Commission” follows the Soviet elite who wished for a this-worldly resurrection. He sees similar aspirations today:

The hopes that led to Lenin’s corpse being sealed in a Cubist mausoleum have not been surrendered. Cheating aging by a low-calorie diet, uploading one’s mind into a super-computer, migrating into outer space [are all present day aspirations] . . . Longing for everlasting life, humans show that they remain the death-defined animal.

Today it is not a communist elite that is likely to continue the immortality project, but rather those billionaires who believe their lifespans should be as much longer than the average Joe’s as their fortunes eclipse his bank account. There is a slight chance the innovations they fund can “trickle down” to all, but in a world of limited resources, new variations on cryonics may not be the best place for funds to be allocated.

A Trip to the Cardiologist, A Lipitor Future, and “Why Doesn’t My Health Insurer Want Me to Know if I’m Likely To Have a Heart Attack?”

I visited with a cardiologist last week. My inadvertent but no less harmful dalliance with two different kinds of drain cleaner having set off an entire chain of long past due check-ups. A little more than two years shy of fifty, I listened intently as I was told that although I had had a good run, a diet composed of grease, chocolate, quick carbs, coffee and unfiltereds was simply not going to cut it as I ventured into the last half of life (last third is more likely, but also more painful to consider– and I suppose for the doctor, harder to say).

I now look forward to a battery of tests. The first, done today, is designed to detect artery calcification: “Coronary calcium is specific for atherosclerotic plaque and can be detected with high sensitivity and accurately quantified by computed tomography (CT) to help predict future cardiac events related to coronary artery disease.” I had to pay for the test out of pocket as it seems my insurance company deems such screening unworthy of coverage– despite the tests highly vaunted predictive power. Quite a few people in this country die each year from heart disease–hard to understand how it wouldn’t be worth the $318 to know who was vulnerable–and if unchecked, destined for the very expensive Intensive Care Unit.

Tomorrow brings an echocardiogram and my first ever stress test. I readily assented to the tests as it is good, I suppose, to know where one stands. But in addition to testing and making dietary changes, the doctor also wants me to start taking Lipitor. A statin prescribed to lower cholesterol. I did not react well.  The prescription it seems is, in more than one sense, a life sentence.

And I am generally suspicious of the pharma zeitgeist. And terribly so as it concerns myself.

The prescription is not, in this instance, a treatment for an acute condition, it treats the endemic. If one has risk factors, it is prophylactic and is prescribed to reduce the risk of heart attack, stroke and other heart diseases. It is doubtful whether once I start taking this drug I will ever stop. There is no foreseeable time (while alive) that I will wish to stop reducing the risk of heart attack or stroke. And that I suppose is the essence of the onset of age– piling up prescriptions. A daily regimen that will follow one to the grave–only the dosages or the brand names changing as each day welcomes a regimen of pills. In short, this prescription feels like the onset of dependence. The forward guard, if you will. A harbinger of a pharmaceutical future.

Seeing my, shall we say, chagrin, the cardiologist told me that, like over 50% of the cardiologists he knows, he takes a statin. “We’ve seen the data.” Another recently told me  “Yeah, I take it. They should put it in the water.”

And so I will take this drug. But I am not happy. I am loath to think of myself in these terms. Only 12 or so years ago I played starting defensive tackle on a semi-pro football team. Soon I will be discussing my cholesterol numbers and God only knows what other numerical health indicators at cocktail parties.

The essence of good health is simply not having to think about it. It is not an issue. I have to think about it now. And I have a sneaking suspicion, that like when I first became a parent, the terms of my existence have just changed.

UPDATE

Photo credit to incurable_hippie.

Access to HIV/AIDS Medicines

The Campaign for Access to Essential Medicines explains why UNITAID’s efforts to develop a patent pool of HIV/AIDS treatments are so important:

Meanwhile, the US health care finance system appears to be getting into a bit of a standoff with HIV/AIDS drug makers:

Without reliable access to the medications, which cost patients in the AIDS Drug Assistance Program an average of $12,000 a year, people with H.I.V. are more likely to develop full-blown AIDS, transmit the virus and require expensive hospitalizations. Eleven states have closed enrollment in the federal program, most recently Florida, which has the nation’s third-largest population of people with H.I.V.

The need for programs like the Health Impact Fund is more urgent than ever.

Veterans, Health Care and the VA

Consider this a follow-up to my Memorial Day post on Veterans & Health Care. There’s an interesting article over at GoozNews regarding health care for veterans at the VA. Goozner writes:

Journalist Phil Longman at the New American Foundation recently updated his book “Best Care Anywhere,” which documents the 1990s rejuvenation of the Veterans Administration’s health care system. Between editions, the wars in Iraq and Afghanistan placed strains on the VA not seen since Vietnam. Here’s his thoughts on the current state of the system, and the lessons its transformation holds for other delivery systems in the U.S.

How does contact with the VA healthcare system compare in terms of
medical outcomes for its patients? How about in other measures of
quality?

In study after study published in peer‐reviewed journals, the VA beats other health care providers on virtually every measure of quality. These include patient safety, adherence to the protocols of evidence medicine, integration of care, cost‐effectiveness, and patient satisfaction. The VA is also on the leading edge of medical research, due to its close affiliation with the nation’s leading medical schools, where many VA doctors have faculty positions. The VA has its problems, but compared to those found elsewhere in the U.S. health care system, it offers “Best Care Anywhere.”

Read more

Veterans & Health Care

As we come upon Memorial Day, it is fitting that we take a moment to consider health care and veterans. We are, after all, a Nation at war. And we have been at war now for closing in on a decade; the casualties mount. As of May 28, 2010 the Department of Defense official number for American deaths is 5,480. My own research experience with official DoD representations in Seton Hall Law’s world renowned GTMO Reports leaves me somewhat skeptical as to the numbers (I cannot tell, for instance, whether post-service and/or inactive reserve veteran suicides are included in this number, but suspect they are not: “There is no epidemic in suicide in VA,” Dr. Ira Katz, the VA’s head of Mental Health told CBS News in November. “But in this e-mail to his top media adviser, written two months ago, Katz appears to be saying something very different, stating: ‘Our suicide prevention coordinators are identifying about 1,000 suicide attempts per month among veterans we see in our medical facilities’” ). Having said that, as in the GTMO reports, we’ll take the government at its word. Not counting civilian contractors, in addition to 5,480 deaths, 37,865 are said to have been wounded. The ratio of wounds to death is approximately 7 to 1.

Such a high ratio of wounded to deaths is a feature of advancing medical technology. More of the injured are kept alive. A quick look at the ratios of deaths to wounded in other American wars witnesses a trend capped off with a precipitous jump.

War	Deaths	Wounded	Approx. Ratio
Civil War (Union only)	281,881	364,511	1 to .8
Spanish-American	2,446	1,662	1 to .7
WWI	116,516	204,002	1 to 1.8
WWII	405,399	671,846	1 to 1.7
Korea	36,913	103,284	1 to 2.8
Viet Nam	58,177	153,301	1 to 2.6
Iraq & Afghanistan	5,480	37,865	1 to 6.9

In modern warfare, through advances in medical technology, more lives are saved, more of the critically injured are kept alive; but it is also true that many of those lives saved have been affected by wartime trauma in often serious and debilitating ways. Many have lost limbs and sight and hearing, experienced traumatic brain injuries, and suffer from grave psychological harm. They do and will require care. We, as a Nation, committed to that care the moment we sent those men and women into harm’s way.

In his Memorial Day address, Secretary of Veterans Affairs, Edward K. Shineski, offered the following quote:

“Poor is the Nation that has no heroes, but beggared is the Nation that has and forgets them.”

This Memorial Day, as we honor those who gave their all in service of their country, let’s not forget our end of the bargain. The care for the families of the fallen and of disabled veterans is perhaps the most sacred contract of all. Men and women who risk their lives for their country have every right to expect that that country will help take care of them –and their families–to the utmost of its ability in the event that they are in some way hurt, disabled or deceased. We simply cannot ask of them to serve and risk if we are not there to help mend.

On May 5, 2005 President Barack Obama signed into law the Caregivers and Veterans Omnibus Health Services Act.

At signing the President said the following:

With this legislation, we’re expanding mental health counseling and services for our veterans from Afghanistan and Iraq, including our National Guardsmen and Reservists. We’re authorizing the VA to utilize hospitals and clinics outside the VA system to serve more wounded warriors like Ted with traumatic brain injury.

We’re increasing support to veterans in rural areas, with the transportation and housing they need to reach VA hospitals and clinics. We’re expanding and improving health care for our women’s veterans, to meet their unique needs, including maternity care for newborn children. And we’ll launch a pilot program to provide child care for veterans receiving intensive medical care.
We’re eliminating co-pays for veterans who are catastrophically disabled. And we’re expanding support to homeless veterans, because in the United States of America, no one who has served this nation in uniform should ever be living on the streets.

Finally, this legislation marks a major step forward in America’s commitment to families and caregivers who tend to our wounded warriors every day. They’re spouses like Sarah. They’re parents, once again caring for their sons and daughters. Sometimes they’re children helping to take care of their mom or dad.

These caregivers put their own lives on hold, their own careers and dreams aside, to care for a loved one. They do it every day, often around the clock. As Sarah can tell you, it’s hard physically and it’s hard emotionally. It’s certainly hard financially. And these tireless caregivers shouldn’t have to do it alone. As of today, they’ll be getting more of the help that they need.

If you’re like Sarah — and caring for a severely injured veteran from Afghanistan or Iraq — you’ll receive a stipend and other assistance, including lodging when you travel for your loved one’s treatment. If you need training to provide specialized services, you’ll get it. If you need counseling, you’ll receive it. If you don’t have health insurance, it will be provided. And if you need a break, it will be arranged — up to 30 days of respite care each year.

So today is a victory for all the veterans’ organizations who fought for this legislation. It’s a tribute to those who led the fight in Congress, including Senator and World War II vet Danny Akaka, and Senator Richard Burr; and in the House, Representatives Mike Michaud and Bob Filner. And I thank all the members of Congress who are joining us here today.

This law looks like a good step in the right direction. I’ve been highly critical in the past regarding the politics first agenda of a bickering and often, it seems, obstructionist Congress. Such was not the case here. As politics has absolutely no place in this discussion, I commend all involved for a job well done.

But if this legislation fails to make available needed services to veterans and their families, and you have experienced such personally, please consider Health Reform Watch open to you as a forum to make systemic shortcomings known to a wider audience.  I can be reached at michael.ricciardelli@shu.edu and I will work with you to publish your thoughts and experience as an article.

May God bless our troops and the families of those who have served.

An Update on the So-Called Young Invincibles: What Health Care Reform Does for Them

Last year I wrote about why the misconceptions about my generation, dubbed “young invincibles” by many, have perpetuated a belief that young people do not care about health insurance.  Thankfully, the health care reform legislators realized that we too, with our superpowers and all, prefer to be healthy and insured.

The most immediate benefit that dependent young people will see under the Patient Protection and Affordable Care Act is the ability to stay on their parents’ insurance until the age of 26; this will take effect in six months. For recent college graduates, and many who have chosen not to pursue a college education, this brings a sigh of relief. The bill also loosens the requirements for who qualifies as a dependent. Even for those who will be approaching 26 soon after the bill passes, the new age limit will afford some time to get coverage through a job with benefits. Marriage status may not necessarily restrict whether or not a child can stay on their parents insurance, as noted by young uninsured expert Sara Collins. Employed children may also qualify for the dependency status as long as they do not have the option of health insurance through their employer. The new bill also applies to all health plans, whether fully insured or self-funded, which was not the case under most state health care extensions to young people.

For those young people that will be 26 before this September, there are other options. The organization that helped esure representation of young people throughout the health care debate, aptly named Young Invincibles, provides a timeline of the other health reform bill measures that will offer help to the young uninsured. It also shows  when these provisions will take effect.

One of the main benefits to consider is that by 2014, more young people will qualify for Medicaid. This will help insure about 9 million young people. Young Invincibles co-founder Ari Matusiak finds that young people will be some of the greatest beneficiaries of the health care reform bill because the young population is currently the poorest of the age demographic groups and because the bill aims to make health care more affordable for those least able to afford it.

One of the other benefits young people will be afforded comes in the form of  tax credits to purchase insurance from the individual market. These are available to those individuals who earn less than $43,320. While the individual market is not the friendliest place to be, new reform measures will ensure that health care prices will not be based on pre-existing conditions and limits the ratio of premiums based upon age (down to 3:1).  The pre-existing condition restriction certainly helps those young people who have chronic conditions (about 15% of us.) Though the age rating restriction benefits older people more than young people, Ari Matusiak rightfully points out that young people are not going to be young forever and can appreciate the idea that we will have security of being able to get insurance without being discriminated against in the future.

Scare tactics are rearing their ugly head again, as many say that the new benefits offered to young people are just increased burdens. Yes, young people will be required to purchase insurance under the new reform bill or they will be subject to a penalty.  The fine will be $95 in 2014 and will gradually increase each year (until 2016, when it tops out at $695 or 2.5% of an individual’s annual income). Given this minimal penalty at the outset, many assume that young people will opt out of purchasing insurance and just pay the fine instead. These are the same people that think young people don’t care about feeling secure with health insurance.  Well, to put this succinctly, we do care. Some may, out of economic desperation, eschew coverage, but so many of us have relatives and friends who have had catastrophic health issues that have left them in debt (or further in debt), that the choice is not likely to be made lightly. We have had our own health issues.  We need prescription medicines and regular checkups. We are not invincible– and we know it.

A majority of us are supportive of the health reform bill.  As young people, we must educate ourselves about the health reform bill so that we know where we stand. We are an integral piece of the reform legislation working as planned.  And while we won’t be duped to do something that harms us more than helps us, we also won’t be beguiled into believing that the new health care legislation is not for us — it is for us– and we should reap its benefits as part of our political patrimony, knowing that in doing so we also help to provide for our posterity.

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