Filed under: Medical Malpractice, Quality Improvement, Research, Treatment
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.”
“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.
[Ed. note, we are pleased to welcome Suzan Sanal to HRW. A second year law student at Seton Hall University School of Law pursuing a Health Law concentration, she is a representative of Seton Hall's Health Law Forum and is presently interning at the Community Health Law Project, a New Jersey based nonprofit advocacy and legal services organization, working on issues relating to the Affordable Care Act and grant writing.]
As Health Reform Watch author Jae W. Joo wrote back in 2010 , studies have shown a “woeful lack of communication (and a wide gap in perception) between hospital staff physicians and ‘their’ patients.” Chaplain Sharon Hindle, oncology chaplain and educator at Robert Wood Johnson University Hospital, knows this woe all too well. Hindle began in 1998 working as a hospital chaplain to comfort patients during the most traumatic period of their lives. She soon found out, however, that patients not only need comfort, but they also need advocacy.
“I end up being a liaison between the doctors and the patients,” Hindle stated in an interview with Health Reform Watch. “I really felt that people were the most vulnerable and the least capable at this point in their life, because they don’t know the language and they’re making a life altering decision. I became a chaplain because I first wanted to become an advocate.”
Hindle places blame on medical education, “There are very few opportunities where [medical students] are being told how to communicate the medical information that they have to the patient.” In response to this, Hindle began running workshops for medical students, interns, and fellows in order to address patient concerns. Through these workshops, she said, “We’re teaching physicians to be engaging, loving, caring, and intuitive.”
These workshops teach skills such as how to have a family meeting, how to deliver bad news, and how to train the patient to provide self-care. In these workshops, Hindle stresses two questions physicians should be asking their patients, the first being “Can you tell me about your medical situation?” From this, physicians can gather what the patient, or the family member if the patient is not conscious, understands and assess their intellectual, language, and emotional skills. Hindle said, “That question gives you their starting line- that way you don’t offend, patronize, or start way ahead of the patient or family’s capability to comprehend.” She described that doctors sometimes think that a patient is experiencing denial if they do not seem to understand the gravity of the situation, when in fact, the patient simply does not comprehend his or her diagnosis.
The second question is “Do you have any questions before we begin this conversation?” Hindle said that asking this question before communicating medical information allows the patient and the family to “Open-up their listening skills because they’re no longer ruminating about what questions they need to ask.”
At the cardiac and neurology intensive care units workshop held in Robert Wood, she meets with students during their one-month rotation. Hindle teaches the importance of asking these two questions and holds a discussion on a current case where students are having difficulty communicating to the patient and/or the patient’s family. At the University of Medicine and Dentistry of New Jersey (UMDNJ), she participates on a panel that includes a social worker, a physician, and a psychiatrist. The panel reviews a case and each professional discusses their role in interacting with the patient. Students may then ask questions.
There are also opportunities for students to participate in small groups reviewing a mock case study with an attending physician and professor at UMDNJ and a professional considered trained in verbal skills, like Hindle. In review of these mock scenarios, Hindle says, “When you are telling someone that they have a life-threatening or life-ending illness, it’s terrifying because you don’t know how the patient and the family is going to react, so it sets-up a situation where maybe these young medical students try to dance around it and make it seem less catastrophic than it is. It’s important for them to practice the words coming out of their mouth.”
Hindle finds that family practice and oncology are probably the most engaged specialties in running these workshops. She labels these types of fields as “relational,” because the physician may have a relationship with this patient over a lifetime, which is why she stresses the value of communication. Hindle contrasts these types of fields with specialties such as surgery and orthopedics, where a patient may have only a short-term relationship with a doctor. She therefore believes there is less of a need for refined communication skills with this second group. Hindle said, “If I need brain surgery, I don’t care if the guy’s a jerk, I just need him to do this brain surgery once. I just need him to be the best brain surgeon in the world. But If I need a physician that I’m going to have a relationship with, there needs to be a symbiotic relationship where there’s trust. Trust that I’m heard.”
If patients do not feel that a symbiotic relationship is present, Hindle strongly encourages patients to speak up. “As a patient, you need to be your own advocate,” Hindle said. She continues, “If, in fact, you do not believe you are being heard, you need to speak up until you believe you’ve been heard. Nobody is going to know your body as well as you. It’s terrible, but you’re a consumer.”
Other particular areas which Hindle believes need to be addressed are: teaching physicians how to cope with loss, failure, and rejection. She believes there is a need to have an appropriate connection with a patient while not becoming emotionally involved.
In the broad view, Hindle understands that good communication with a doctor can have a profound impact on the patient’s physical well-being and recovery. Hindle said, “My feeling is that our body only has so much energy. [...] If you feel you’ve been heard by your medical team, it really alleviates stress. Your body can now use all of that towards healing.” In close, Hindle continues to feel encouraged about the strengthening of patient-doctor communication, “In the ten years I’ve been at Robert Wood, I’ve seen a tremendous difference in the patient perception on communication. They see that on the whole, doctors are communicating better and they really do care.”
Chaplain Sharon Hindle is an oncology chaplain and educator at Robert Wood Johnson University Hospital in New Brunswick, New Jersey. She also volunteers her expertise at the University of Medicine and Dentistry of New Jersey. Hindle has a blog entitled “Taken Oasis” (
http://www.takenoasis.com/). She was also recently interviewed by Inside Jersey and a video interview is soon to appear on Robert Wood Johnson’s You Tube channel. Hindle considers Robert Buckman’s techniques in his book, “How to Break Bad News: A Guide for Health Care Professionals,” the gold standard for doctor-patient communication. She also notes Christina M. Puchalski, MD and Harold Koenig, MD as important voices in the field.
Filed under: Medical Malpractice, Quality Improvement
I’ve written before here about hand-washing (or should I say, not-hand-washing) among hospital staff within the context of the wider issues of infection, avoidable patient harm, death and malpractice.
I noted prior that the New York Times had observed that a study of eight New York hospitals and hand washing showed “low compliance rates, which ranged from about 30 percent to 70 percent at individual hospitals….” And that
Findings of shockingly poor hand-washing compliance are not new in hospitals. Other studies have produced comparable figures, and the stories of fatal consequences have become tragically routine.
The disease control agency estimates there are 1.7 million infection cases a year in hospitals and that 99,000 patients die after contracting them (although infection may not be the sole cause). It projects the cost of treating those patients at $20 billion a year.
In response, I suppose, we have this. A study by Armellino D., et al., entitled “Using high-technology to enforce low-technology safety measures: the use of third-party remote video auditing and real-time feedback in healthcare.”
I’ll save you the commentary and just go straight to the Abstract listed over at Medscape with a hat-tip to Natural News and Dr. William R. Jarvis (further details of study, plus video). Truth is, I really don’t know how to feel about this.
Department of Epidemiology, North Shore University Hospital, Manhasset, NY, USA.
Hand hygiene is a key measure in preventing infections. We evaluated healthcare worker (HCW) hand hygiene with the use of remote video auditing with and without feedback.
The study was conducted in an 17-bed intensive care unit from June 2008 through June 2010. We placed cameras with views of every sink and hand sanitizer dispenser to record hand hygiene of HCWs. Sensors in doorways identified when an individual(s) entered/exited. When video auditors observed a HCW performing hand hygiene upon entering/exiting, they assigned a pass; if not, a fail was assigned. Hand hygiene was measured during a 16-week period of remote video auditing without feedback and a 91-week period with feedback of data. Performance feedback was continuously displayed on electronic boards mounted within the hallways, and summary reports were delivered to supervisors by electronic mail.
During the 16-week prefeedback period, hand hygiene rates were less than 10% (3933/60 542) and in the 16-week postfeedback period it was 81.6% (59 627/73 080). The increase was maintained through 75 weeks at 87.9% (262 826/298 860).
The data suggest that remote video auditing combined with feedback produced a significant and sustained improvement in hand hygiene.
Filed under: Drugs & Medical Devices, Health Law
As much as I write about medical malpractice, it seems only fair that I devote a post and direct our fair readers to the other side of the bar: The Drug and Device blog put out by a number of Dechert, LLP attorneys involved in pharmaceutical and medical device product liability litigation– from the defense side– And Writing in Their Individual Capacities (yes, I read the disclaimer– which is itself a piece of art).
I don’t know that our non-law-based readers would find the site of much interest, but for those of you who do have a legal background– it’s really quite good– and rather funny (though it doesn’t hurt if you have a taste for the acerbic). And I’m not just saying this because today’s post I so enjoyed turned out to have a hat tip to former classmate and worthy opponent Lincoln Wilson at the bottom of it. The blog is good. And if you’re a lawyer– or a law professor– today’s post should be disquieting for you.
The post, entitled “Another Homework Failure By Plaintiffs,” is about a suit against Endo Pharmaceuticals re: Darvocet and how the plaintiffs cause of action burst into flames when it saw the light of a federal judge– for lack of personal jurisdiction. The article points out (pointedly) that the court notes that although the burden of showing jurisdiction is “relatively slight,” plaintiff’s offered no facts. None. Plaintiffs asserted that Endo, which purchased three entities (which still now exist) that had formerly produced the drug in question, “may have assumed responsibility for the acts…” and claimed the court needed to find personal jurisdiction based on the facts. The court:
But what “facts”? The portion of the complaint relied upon by the plaintiffs merely implies that the Endo Defendants “may have” somehow assumed the liabilities of their subsidiaries; the only factual assertion [plaintiff's allegation] contains is that the plaintiffs do not have the information they need to establish personal jurisdiction. Thus, even if the plaintiffs were permitted to stand on their pleadings, they would fall woefully short of the necessary prima facie showing.
I think that’s going to leave a mark.
I said above that if you were a law professor or a lawyer you would find the Drug and Device post disquieting. But maybe I was hasty with regard to other lawyers. Although there is great value in a learned bar, the value of an unprepared opponent is, I suppose, inestimable. At least in the short run.
Having said that, if you have a few minutes, check out the Drug and Device blog article– and the slip opinion of the case they’ve conveniently provided. It’s worth it. From a stand point of pedagogy, it may not be as useful as the numerous Texas appeals filed late resulting in execution, but it could certainly function as a cautionary tale.
Filed under: Electronic Medical Records, IT, Medical Journals, Medical Malpractice
If one jumbo jet crashed in the US each day for a week, we’d expect the FAA to shut down the industry until the problem was figured out. But in our health care system, roughly 250 people die each day due to preventable error. A vice president at a health care quality company says that “If we could focus our efforts on just four key areas — failure to rescue, bed sores, postoperative sepsis, and postoperative pulmonary embolism — and reduce these incidents by just 20 percent, we could save 39,000 people from dying every year.” The aviation analogy has caught on in the system, as patient safety advocate Lucian Leape noted in his classic 1994 JAMA article, Error in Medicine. Leape notes that airlines have become far safer by adopting redundant system designs, standardized procedures, checklists, rigid and frequently reinforced certification and testing of pilots, and extensive reporting systems. Advocates like Leape and Peter Provonost have been advocating for adoption of similar methods in health care for some time, and have scored some remarkable successes.
But the aviation model has its critics. The very thoughtful finance blogger Ashwin Parameswaran argues that, “by protecting system performance against single faults, redundancies allow the latent buildup of multiple faults.” While human expertise depends on an intuitive grasp, or mapping, of a situation, perhaps built up over decades of experience, technologized control systems privilege algorithms that are supposed to aggregate the best that has been thought and calculated. The technology is supposed to be the distilled essence of the insights of thousands, fixed in software. But the persons operating in the midst of it are denied the feedback that is a cornerstone of intuitive learning. Parameswaram offers several passages from James Reason’s book Human Error to document the resulting tension between our ability to accurately model systems and an intuitive understanding of them. Reason states:
[C]omplex, tightly-coupled and highly defended systems have become increasingly opaque to the people who manage, maintain and operate them. This opacity has two aspects: not knowing what is happening and not understanding what the system can do. As we have seen, automation has wrought a fundamental change in the roles people play within certain high-risk technologies. Instead of having ‘hands on’ contact with the process, people have been promoted “to higher-level supervisory tasks and to long-term maintenance and planning tasks.” In all cases, these are far removed from the immediate processing. What direct information they have is filtered through the computer-based interface. And, as many accidents have demonstrated, they often cannot find what they need to know while, at the same time, being deluged with information they do not want nor know how to interpret.
A stark choice emerges. We can either double down on redundant, tech-driven systems, or we can try to restore smaller scale scenarios where human judgment actually stands a chance of comprehending the situation. We will need to begin to recognize this regulatory apparatus as a “process of integrating human intelligence with artificial intelligence.” (For more on that front, the recent “We, Robot” conference at U. Miami is also of great interest.)
Another recent story emphasized the importance of filters in an era of information overload, and the need to develop better ways of processing complex information. Kerry Grens’s article “Data Diving” emphasizes that “what lies untapped beneath the surface of published clinical trial analyses could rock the world of independent review.”
[F]or the most part, [analysts] rely simply on publications in peer-reviewed journals. Such reviews are valuable to clinicians and health agencies for recommending treatment. But as several recent studies illustrate, they can be grossly limited and misleading. . . . [There is] an entire world of data that never sees the light of publication. “I have an evidence crisis,” [says Tom Jefferson of the Cochrane Collaboration]. “I’m not sure what to make of what I see in journals.” He offers an example: one publication of a Tamiflu trial was seven pages long. The corresponding clinical study report was 8,545 pages. . . .
Clinical study reports . . . are the most comprehensive descriptions of trials’ methodology and results . . . . They include details that might not make it into a published paper, such as the composition of the placebo used, the original protocol and any deviations from it, and descriptions of all the measures that were collected. But even clinical study reports include some level of synthesis. At the finest level of resolution are the raw, unabridged, patient-level data. Getting access to either set of results, outside of being trial sponsors or drug regulators, is a rarity. Robert Gibbons, the director of the Center for Health Statistics at the University of Chicago, had never seen a reanalysis of raw data by an independent team until a few years ago, when he himself was staring at the full results from Eli Lilly’s clinical trials of the blockbuster antidepressant Prozac.
There will be a growing imperative to open up all of the data as concerns about the reliability of publications continue to grow.
As proof that the only news in health law does not involve the Supreme Court’s consideration of the challenge to the Affordable Care Act, here are some interesting recent articles that are worth a read:
1. Frank McClellan and others recently released the results of their study, “Do Poor People Sue Doctors More Frequently? Confronting Unconscious Bias and the Role of Cultural Competency.” Some doctors perceive that socioeconomically disadvantaged patients tend to sue their doctors more frequently, which has influenced them not to provide care or to provide care in different ways to this population. For example, 57 percent of physicians polled in California in 1995 cited this belief as important in their decision not to treat Medicaid patients. Yet McClellan and his co-authors review studies showing that, to the contrary, poor patients tend to sue their physicians less often than other groups. Indeed, there is evidence that patients in lower socioeconomic groups are also less likely to file nonmeritorious malpractice claims. One possible explanation that the authors of this project offer to explain this disconnect between physician perception and fact is unconscious or implicit bias, which “describes thinking and decision making affected by stereotypes without one being aware of it” that “can explain why people may consciously believe in a truth, whereas their behavior, affected by subconscious prejudices, is contrary to that truth.” For example, physicians unconsciously concerned that poor patients will not adequately compensate them for their care “might consciously or unconsciously presume poor patients are more likely to sue as an excuse or way of avoiding the presumed difficulty associated with collections from such patients.” The authors of this study make recommendations to confront unconscious bias and provide culturally competent care (“CCC”), including increasing diversity, educating providers about CCC, improving provider communication skills, and enhancing patient health literacy. CCC educational efforts are especially valuable in specialties like orthopaedic surgery, where approximately 84 to 89 percent of providers are white males. It is thought that these efforts will improve medical care to lower socioeconomic groups and reduce the risk of malpractice claims.
2. In “Diversion of Offenders with Mental Health Disorders: Mental Health Courts,” Sarah Ryan and Dr. Darius Whelan review the use of mental health courts in the United States, Canada, England, and Wales and consider whether these courts should be established in Ireland. The article first reviews Therapeutic Jurisprudence (“TJ”), a foundational theory underlying problem-solving courts like mental health and drug courts that “promotes the employment of a ‘problem-solving pro-active and results oriented posture that is responsive to the current emotional and social problems of legal consumers.’” While advocating its strengths, the authors also warn of the danger that paternalistic applications of TJ can water down due process and rule of law values. They then identify and compare features of mental health courts that have developed in the United States, Canada, England, and Wales since the pioneer court started operating in Broward County, Florida in 1987. After evaluating the main merits (e.g., more appropriate treatment and potentially reduced recidivism and costs) and criticisms (e.g., concerns about coercion, waiver of due process rights, stigmatization and segregation of the mentally ill, diversion of resources, and lack of empirical data that they are effective) of these courts, the authors conclude that mental health courts could offer a partial solution to the challenges facing Ireland’s criminal justice system. Not surprisingly, they urge policymakers to select the best features of the programs that have evolved to date and to apply TJ “in a careful manner, to avoid interference with defendants['] constitutional rights.” For example, the authors recommend that a solicitor be appointed at the first indication an offender could be eligible to participate. Further, they believe that Ireland should not require offenders to plead guilty as a pre-condition to participate in the program because such a requirement is “antithetical to the goal of decriminalising the mentally ill.” They warn, however, that for the program to be viable, Ireland would have to allocate substantial funding to develop community mental health treatment facilities.
3. Recent Harvard Law School graduate Maggie Francis has written, “Forty Years of ‘Testing, Testing’: The Past and Future Role of Policy Experimentation in Healthcare Reform,” which reviews the federal government’s use of pilot projects and demonstration projects over the past forty years to test innovative health reform ideas. As Ms. Francis describes, her article is the “first . . . in the legal literature to analyze the use of systemic policy experimentation by the federal government to reform the healthcare system.” She describes the number and types of problems facing the healthcare system and why policymakers have chosen pilots as a means of addressing these problems. The article then evaluates whether pilot projects are a useful tool in healthcare reform. Ms. Francis identifies numerous advantages to pilots, including that they provide some cover to controversial innovations from political pressures and permit government to try multiple theories in different pilots to assess what works better in different populations, locations, etc. and to make adjustments based on experience that should make large-scale implementation smoother. She also warns of some possible roadblocks, including lack of adequate information and competence to select the right pilots and then to oversee their implementation and evaluation. A common criticism of these programs is that they take too long to test new ideas and expand those that are successful. Securing consistent funding has also been a challenge. In addition, political interference and gamesmanship can undermine efforts to innovate. Ms. Francis concludes that, despite their limitations, pilot projects satisfy policy makers’ need for information about reform ideas and their consequences and offer the most promise where “organizational challenges, rather than stakeholder opposition and distributional problems, are the primary obstacle to reform.” As a result, she posits that pilots might be more successful at encouraging widespread adoption of less controversial innovations, such as medical homes, than with contributing “significantly to the goal of cost control, which necessarily raises contentious distributional issues among powerful stakeholders in the healthcare industry and is likely to trigger rent-seeking behavior by interest groups.” Ms. Francis’s observations are not merely historically interesting but rather offer important insights given the variety of pilot projects included in the ACA to help identify a politically viable way to bend the healthcare cost curve while improving quality. Ms. Francis reviews the diverse medley of pilots in the ACA, including, but far from limited to, the creation of the Center for Medicare and Medicaid Innovation, reminding us all how much more there is to the ACA than just the mandate and how much we will learn from its implementation.
The survey/study is said to have had a response rate of roughly 64% (3,500 physicians from seven specialties were queried) and was published by doctors Lisa I. Iezzoni, Sowmya R. Rao, Catherine M. DesRoches, Christine Vogeli and Eric G. Campbell.
The Journal reports that the study found
…a significant chunk of doctors — 34.1% and 35.4% respectively — said they only somewhat agreed or disagreed with the notions that they should disclose all significant medical errors to affected patients and that they must tell patients about relationships with drug and device companies.
What about actual practice? Well, 55.2% of respondents said they’d described a patient’s prognosis in a more positive way than was warranted at least once in the past year. More than 28% said they’d revealed confidential medical info to an unauthorized person (intentionally or not), and nearly 20% reported not fully disclosing an error to a patient out of fear of being sued. Finally, 11% admitted to outright telling an adult patient or child’s guardian “something that was not true.”
Soft peddling a diagnosis can be a form of mercy, with this I have no qualm. And I imagine there can be a number of reasons, under the same tent as mercy, for telling an untruth to a patient or a parent. And maybe even a 28% HIPAA violation rate can be explained through some further form of altruistic behavior. But the fact that over the last year, of these 1,891 physicians, “20% reported not fully disclosing an error to a patient out of fear of being sued,” is reason for pause.
To admit to such is, in a sense, an admission against interest; which is to say that one would not be surprised if the actual number was higher than admitted. In fact, according to the study’s abstract, “Overall, approximately one-third of physicians did not completely agree with disclosing serious medical errors to patients.”
But take the 20% number on its face for a moment and consider the math: of 1,891 physicians that’s 378 errors during the course of one year which, in their professional opinion, could have led to a malpractice suit– and so were not disclosed. With less than 2,000 doctors, 378 errors that people are walking around with– or at least the lucky ones are walking around with– unknown and uncompensated.
Granted, with a J.D. after my name and given my own experiences with malpractice and the sound and fury I regularly hear regarding “malpractice reform,” I may look at this number differently than some. But it seems large to me– and I’m guessing it would seem a little large to its victims too, if only they knew.
It’s Been Over 50 Years Since the Discovery of Methicillin Resistant Staphylococcus Aureus (MRSA): An Anniversary No One is Celebrating
[Ed. Note: We are pleased to welcome Tara J. Hopper to HRW. She is a candidate for a Master of Laws (LL.M) degree in Health Law here at Seton Hall Law, having recently graduated from Nova Southeastern University Shepard Broad Law Center, where she received her Juris Doctor with a concentration in Health Law. She also holds a Masters of Social Work (M.S.W.) with an emphasis in mental health from Barry University. She has worked as a mental health therapist, a mental health advocate and legislative advocate for the Advocacy Center for Persons with Disabilities, Inc., as well as ChildNet, Inc., and as the Senior Legislative Aide to Florida State Senator Walter "Skip" Campbell while he was acting as Senate Chair of the Committee on Children and Families. She became a strong advocate for creating awareness of, and drafting legislation to help protect patients from, methicillin resistant staphylococcus aureus (MRSA) after her best friend died of MRSA at the age of 33 in 2008. ]
On October 2, 1960, Dr. Patricia Jevons discovered new strains of Staphylococcus Aureus. These strains were later described as Methicillin Resistant Staphylococcus Aureus (MRSA) after being introduced through the British Medical Journal on January 14, 1961. Thus, the discovery of MRSA was fifty-one years ago this month, and the year 2011 marks the 50th anniversary of when MRSA received its name and, as such, in a sense, came into being.
Unlike other anniversaries where people come together and celebrate, October 1, 2011 marks the third year in a row where MRSA survivors, family and friends of MRSA victims, and policy-makers, gather together to promote MRSA Awareness and to remember and honor loved ones who have been lost to MRSA. World MRSA Day is October 2nd, and October has been declared World MRSA Awareness Month. The 2011 theme for World MRSA Day is “The MRSA Epidemic – A Call to Action,” and focuses on MRSA as a public health crisis.
MRSA is a bacterial infection that is resistant to penicillin type antibiotics, and for this reason, MRSA has been called a ‘super-bug.’ MRSA acquired within a healthcare setting is referred to as a Healthcare-Associated Infection (HAI), if contracted within the community it is referred to as a Community Associated Infection (CA).
Risk factors for acquiring HAI-MRSA include having a history of hospitalizations or surgeries, living in a long-term care facility such as a nursing home, recent use or long-term use of antibiotics, and having had a previous MRSA infection or colonization.
Risk factors for having acquired CA-MRSA include playing contact sports, sharing equipment or towels at a gym, using illegal intravenous drugs, and living in crowded, unsanitary conditions such as a jail or other institution. Your chances are also increased for developing CA-MRSA if you do not keep a pre-existing wound covered by a bandage, or you have a weakened immune system. It is believed that approximately 1% of the community’s population are “MRSA carriers” and are unaware that they have MRSA because they do not have an infection or any MRSA symptoms. However, MRSA carriers can pass MRSA on to other people who may not have the immune system or antibiotic resistance to fight it. In addition, people who have certain illnesses such as diabetic foot ulcers and cystic fibrosis have an increased risk of death when tested positive for MRSA.
MRSA infections become invasive when the MRSA infection is isolated in an area of the body that is normally sterile such as the blood, bone, lymph nodes, brain, heart, liver, spleen, kidneys, pancreas, ovaries, and various bodily fluids. If an invasive MRSA infection is then left untreated, MRSA can spread throughout the entire body. It is unusual for MRSA to be successfully treated after it spreads to multiple parts of the body. When there is a delay in treatment for an invasive MRSA infection, the fatality rate of MRSA patients significantly increases. Early MRSA detection through mandatory screening allows for treatment of MRSA before it becomes invasive.
Some World MRSA Day activists argue that there has been such an exceptional increase in the incidence of MRSA that MRSA should be declared an ‘epidemic.’ However, MRSA has yet to be declared an epidemic by any state or federal authority. Some experts argue that when data is inadequate to determine whether or not there has been an exceptional increase in the incidence of a disease that a “clear temporal increase” in the incidence should be sufficient to declare an epidemic. Because MRSA screening and MRSA reporting requirements are not mandatory, except in a few states, it is likely that data is inadequate to determine the actual incidence of the disease.
However, recent data regarding MRSA related deaths show that The Center for Disease Control reported in 2007 that “approximately” nineteen thousand people die from MRSA every year. Other studies report that antibiotic resistant germs such as MRSA contribute to the death of approximately 70,000 hospitalized Americans each year. It is unclear, due to a lack of historical data on MRSA, to fully understand the increase in incidence, and figure out how many people need to die in order to justify MRSA being declared an epidemic.
When issues reach epidemic status, federal dollars usually follow so that proper precautions can be taken, and further research can be done to find a cure and/or remedy. With many government agencies tightening their belts across the nation, one may surmise that declaring MRSA an epidemic would be disfavored based on the funding requirements alone. Although an increase in MRSA research funding can promote the development of new antibiotics for MRSA, MRSA research funding does not appear to be a strong federal priority. In 2010, it was reported that scientists at the University of Nottingham in the UK researched cockroaches and locusts and found that tissues from their brain and nervous system of these bugs killed more than ninety percent of the MRSA in the study. Wouldn’t it be ironic if the MRSA Superbug ends up meeting its eternal demise through the use of antibiotics from actual bugs? Hopefully, through an increase in MRSA awareness, MRSA funding and research will increase so that MRSA related deaths can decrease.
Recent trends of state legislatures show both proposals and adoption of MRSA screening and reporting legislation that promote the early identification of MRSA, and preventing the spread of MRSA. Opponents of MRSA screening legislation argue that it is too costly, impractical and inconvenient. However, MRSA detection plates are available at only a little more than $1.50 per plate, and screening requires only a simple nasal swab to detect MRSA. Recent advancements in MRSA detection devices make it possible to receive test results within 50 and 75 minutes, whereas test results were previously only available within 18 to 48 hours. This shortened time in obtaining test results gives a hospital the ability to isolate and treat the MRSA patient before MRSA is spread to other parts of the hospital.
Although there are legal concerns that screening and reporting requirements may increase hospital liability in medical malpractice suits, MRSA screening upon admission would also be advantageous to hospitals in order to show that the patient had acquired MRSA before entering their facility, therefore, decreasing their opportunity for liability in these instances. MRSA reporting may initially have a negative impact on hospitals that report higher MRSA rates, but when following MRSA screening procedures and MRSA prevention guidelines such as those provided by The Society for Healthcare Epidemiology of America (SHEA), it is likely that a hospital’s MRSA numbers will significantly decrease. After the adjustment period is over, hospitals may be happy to report just how MRSA-free their facility has become, and everyone will benefit from such a decrease in this life-threatening infection.
Filed under: Antitrust, Pharma, Prescription Drugs, Recommended Reading
Bundles in the Pharmaceutical Industry: A Case Study of Pediatric Vaccines, by Kevin W. Caves and Hal J. Singer of Navigant Economics, provides a technical but still accessible analysis of the anticompetitive effects of vaccine manufacturers’ practice of conditioning price discounts on physician buying groups agreeing to purchase the manufacturers’ vaccines in a bundle and agreeing not to purchase other manufacturers’ products. The article begins with an interesting overview of the characteristics of the vaccine market, an introduction to the physician buying groups that purchase vaccines and to the anti-kickback concerns they raise, and a summary of the (somewhat up in the air) legal standard for when bundled discounting becomes an antitrust violation.
The authors then present their analysis of the uphill battle Novartis (a source of funding for the article) will have to fight to induce physicians to “break the bundle” and buy its new meningitis vaccine. The authors conclude that even if Novartis were to give away its meningitis vaccine for free, “buyers defecting from [Sanofi Pasteur's bundle of vaccines, which includes Sanofi's meningitis vaccine,] would still lose $14.05 per patient in expected value.” They present data indicating “that buyers unencumbered by … Sanofi’s loyalty contracts are over three times as likely to purchase [Novartis' vaccine], relative to encumbered buyers…” and conclude that enough of the market is foreclosed to Novartis to establish a presumption of anticompetitive effects and concomitant harm to consumers. Per the authors, “[i]n an industry served almost exclusively by large, multi-product incumbents, with no prospects for generic competition and extremely limited entry by competitive rivals of any kind, these findings have significant implications for public policy and antitrust enforcement.”
Somewhat less accessible (due to a plethora of equations) but still well worth reading is Tort Liability and the Market for Prescription Drugs by Eric Helland, Darius Lakdawalla, Anup Malani, and Seth Seabury. Helland and his co-authors present the results of an empirical study of the relationship between product liability rules and drug price and utilization. While the effect of a liability rule can often be studied by comparing a state that makes a change to the rule with one that does not, the authors had to modify this approach because drugs are sold nationally. They determined the exposure to punitive damages caps of each of nearly 16,000 drugs by first determining each drug’s geographic distribution of sales, a figure which varies from drug to drug due to geographic variation in the prevalence of disease. The authors found that the degree of exposure to caps was correlated with an increase in drug prices but also with an increase in drug utilization. Tighter liability standards also correlate with a reduction in adverse drug reactions. The authors write that their numbers “imply that if every remaining state adopted some reform, there would be a 23% increase in all [adverse] events and a 25% increase in serious [adverse] events … among branded drugs.” They conclude that “on balance, liability improves consumer and social welfare.”
A recent article in the New York Times by William Glaberson on a form of fast track medical malpractice resolution being piloted in the Bronx is well worth a read and some consideration. The program puts a judge with better than average medical knowledge, assisted by a nurse with legal training, at the center of early negotiations between the parties.
The approach, known as judge-directed negotiation, is seen by the Obama administration as offering states a way to curb liability expenses that have sharply increased health care costs nationally. Getting judges involved earlier, more often and much more actively in pushing for settlements, is its crucial ingredient – evident in the recent session watched by this reporter, one of many that are usually not attended by the public.
New York officials say the program bypasses years of court battles, limiting legal costs while providing injured patients with compensation that is likely to be less than a jury would award but can be paid out years earlier, without lengthy appeals.
Published in 1911, Ambrose Bierce’s Devil’s Dictionary defines “litigation” as “A machine which you go into as a pig and come out of as a sausage.”
With early judicial intervention, as opposed to a forced mediation session just prior to the prospect of trial, it would seem there is more room for negotiation. The lawyers have not spent years in preparation, nor the reams of money requisite for discovery, depositions and reams of medical expert reports. There is, of course, a price to be paid for the time and money invested in lengthy litigation– on all sides.
The Bronx program, overseen by the federal Agency for Healthcare Research and Quality, is for malpractice suits against public entities. But with success comes expansion:
Under a $3 million federal grant, the city courts are now expanding the program beyond the Bronx, where it started in cases against city hospitals, to courts in Brooklyn and Manhattan, as well as to cases against private hospitals. It is to begin in Buffalo courts in the fall.
Success? The Times reports that “The city’s public hospitals say the program, along with other changes, like sharply increased attention to safety, has helped save $66 million in malpractice costs a year.”
And let’s not forget the time. Or that, although there’s some variation in findings, more than 90% and perhaps as high as 98% of all cases ultimately settle anyways.
Reconsidering Law and Policy Debates: A Public Health Perspective, edited by John Culhane, is a superb collection of thought-provoking essays which features some of the most well-regarded health law scholars in the US. It also includes contributors from schools of public health, public affairs, and public administration. The chapters are uniformly well-written and instructive. Though I cannot in this brief review give consideration to all of the essays, I will try to highlight contributions related to some of my own areas of interest in the intersection between public health and medico-legal research.
Several authors focus on the difficult questions raised by extreme inequality. For example, Vernellia R. Randall’s Dying While Black in America reflects on the disturbing disparity between white and black death rates in the US. A black American male can expect to live seven years less than a white American male, and black women face a four-year gap. Randall explores a number of potential explanations, including discriminatory policies and practices, lack of language and culturally competent care, inadequate inclusion in healthcare research, and hidden discrimination in rationing mechanisms. Randall argues that these disparities will never be addressed effectively until the legal system develops doctrines that can deter not only intentional discrimination, but also “negligent discrimination in healthcare:”
Negligent discrimination in healthcare would occur when healthcare providers failed to take reasonable steps to avoid discrimination based on race when they knew or should have known that their actions would result in discrimination. An example of this would be decisions to close inner-city hospitals and move them to the suburbs. (86)
Randall expertly characterizes race as a key “social determinant of health” in the United States. Countering the many current legal doctrines that promote the legitimation of discrimination, Randall envisions the type of guarantees of equality that will be necessary to realize the antisubordination and antisubjugation principles that animate the 14th Amendment properly understood.
Diane E. Hoffman also addresses stunning inequalities, this time on a global level. Hoffman’s long engagement with end-of-life care informs a consistently sensitive and insightful public health perspective. Considering the situation in the United States, Hoffman concludes that “it is not as all clear that we would want to give the state a public health justification for taking on end-of-life care,” because “we might have trouble reining in the government and preventing it from implementing increasingly more coercive measures” (59). This judgment is particularly pertinent in a political environment where extreme inequality and ever-lower taxes on the wealthiest have imperiled many important health programs for the aged.
However, Hoffman comes to a different conclusion in the case of many developing countries, where the question is less one of rationing access to life extending technologies than it is one of extending access to basic treatments for pain. In a sobering series of statistics, Hoffman presents a tragic panorama of human suffering. In India, only 1% of the 1.6 million people enduring cancer pain each year are likely to receive any type of pain medication. Morphine dispensaries are rare; Calcutta, with 14 million residents, has only one. Though nearly half its population is extremely poor, India is not an outlier. While developing countries account for 80% of world population, they use only 6% of the morphine consumed each year. Sometimes, shortages of medical personnel help explain the problem: for example, in Sierra Leone, there is only one doctor for every 54,000 people (as opposed to a 1:350 ratio in the US). But Hoffman gives several examples of easily preventable policies and business practices that keep painkillers out of the hands of the world’s poorest individuals. This is a truly neglected global crisis, generating levels of suffering that are rarely encountered or even imagined in the developed world.
Returning to the US, the last two chapters in the book are very interesting contributions to ongoing debates about the nature and role of tort doctrine. Elizabeth Weeks Leonard expertly deconstructs the usual dichotomy between tort law’s individualism and the population focus of public health. As she notes, cases involving asbestos, lead paint, silicone breast implants, the Dalkon shield, hazardous autos, tobacco, firearms, Phen-Fen, OxyContin, and Vioxx have all combined efforts by individuals to secure compensation for injuries with broader strikes against destructive products and practices. Weeks succeeds in demonstrating the “counterintuitive fit between tort law and public health law” (189), arguing that each “offers approaches to addressing inevitable conflicts in organized society between individual interests and community needs.”
Jean Macchiaroli Eggen tries to make the fit better by focusing on punitive damages. Toward the end of her chapter, she proposes that states solve the “plaintiff windfall problem” in punitive damages by requiring that “the portion of the punitive award the plaintiff does not receive [due to split-recovery statutes and other measures] be allocated to a state or private program that will enhance the deterrence of the conduct that gave rise to the warden the particular case.” The contributions of both Weeks Leonard and Macchiaroli Eggen would be of great interest to tort classes and seminars considering the difficult issues raised by judicial efforts to address public health concerns.
John Culhane is to be commended for bringing together such an illustrious group of contributors to address public health, an issue that has been neglected in law schools. Knowing full well that factors like income, race, pollution, and even commute length may have a far greater impact on health than, say, dispute resolution methods used by insurance companies, law professors nevertheless tend to focus on purely legal topics. (I am as guilty of this as anyone, and credit this book (and many interventions by Daniel Goldberg) for pushing me to do more to consider the social determinants of health in my own work.) Well after the sturm und drang surrounding the constitutionality of the ACA has dissolved, we will still face problems of balancing liberty, equality, and welfare that this book’s thoughtful contributors address. Their voices deserve to be heard in those future, more substantive, debates.
As Memorial Day comes to a close and we ready ourselves for a return to work and all that brings, let’s take a moment, after this single day dedicated to the ultimate sacrifices made by American military men and women, to consider our part of the bargain.
These are the opening paragraphs from an Associated Press article which ran two weeks ago:
Noting that an average of 18 veterans a day commit suicide, a federal appeals court on Tuesday ordered the Department of Veterans Affairs to dramatically overhaul its mental health care system.
In the strongly worded ruling, the 9th U.S. Circuit Court of Appeals said it takes the department an average of four years to fully provide the mental health benefits owed veterans.
The court also said it often takes weeks for a suicidal vet to get a first appointment.
The “unchecked incompetence” in handling the flood of post-traumatic stress disorder and other mental health claims is unconstitutional, the court said.
And, one might add, unconscionable. The AP notes that
The court said a 2007 report by the Office of the Inspector General found significant delays in timely referrals from VA doctors for treatment of PTSD and depression. Fewer than half of the patients received same-day mental evaluations while others had to wait as long as two months for a counseling session.
But wait, there’s more. A questioning attempt at cover up in an email from a high ranking VA official–which begins with an imperative for quiet: The AP notes:
“Shhh!” began a Feb. 13, 2008, e-mail from Dr. Ira Katz, a VA deputy chief. “Our suicide prevention coordinators are identifying about 1,000 suicide attempts per month among the veterans we see in our medical facilities. Is this something we should (carefully) address ourselves in some sort of release before someone stumbles on it?”
Katz wrote in another e-mail that 18 veterans kill themselves daily on average.
And then, an attempt to have VA counselors purposefully misdiagnose. AP reports
After the trial another e-mail surfaced that was written by VA psychologist Norma Perez suggesting that counselors in Texas make a point to diagnose fewer post-traumatic stress disorder cases. The veterans’ lawyers argued that e-mail showed the VA’s unwillingness to properly treat mental health issues.
Judge Stephen Reinhardt wrote for the court:
“No more veterans should be compelled to agonize or perish while the government fails to perform its obligations. Having chosen to honor and provide for our veterans by guaranteeing them the mental health care and other critical benefits to which they are entitled, the government may not deprive them of that support through unchallengeable and interminable delays.”
On Memorial Day we rightly honor our dead. But let’s not forget the sacrifices of the living– or our part of the bargain.
On April 29, the Department for Health & Human Services (HHS) announced the launch of the Hospital Inpatient Value-Based Purchasing (Hospital VBP) program under the Medicare Inpatient Prospective Payment System (IPPS). According to HHS, the Hospital HVP program “marks the beginning of an historic change in how Medicare pays health care providers and facilities-for the first time, 3,500 hospitals across the country will be paid for inpatient acute care services based on care quality, not just the quantity of the services they provide.”
As a part of the launch of the Hospital VBP program, authorized under § 3001(a) of the Patient Protection and Accountable Care Act of 2010 (ACA, codified at 42 U.S.C. § 1886(o)), the Centers for Medicare & Medicaid Services published the final rule outlining the measures, performance standards, scoring methodology, and methodology for translating hospitals’ Total Performance Scores into value-based incentive payments.
Why Should I Care?
Value-based purchasing has been called a “fast-approaching, mandatory competition with millions of dollars on the line.” The program is aimed to fix two previously identified problems: (1) preventable medical errors and (2) resulting health care costs. According to CMS:
One in seven Medicare patients will experience some “adverse” event such as a preventable illness or injury while in the hospital. One in three Medicare beneficiaries who leave the hospital today will be back in the hospital within a month. Every year, as many as 98,000 Americans die from errors in hospital care.
In addition to adding to the suffering of patients and their caregivers, these errors lead to significant unnecessary health care spending. Medicare spent an estimated $4.4 billion in 2009 to care for patients who had been harmed in the hospital, and readmissions cost Medicare another $26 billion.
The Hospital VBP program marks a shift in CMS reforms, from “pay-for-reporting” to “pay-for-performance.” In 2003, the Hospital Inpatient Quality Reporting (IQR) Program introduced the core-measures concept. Hospitals that did not successfully report data under the IQR program were penalized by a 2.0 percentage point reduction in their applicable percentage increase. The Hospital VBP program continues using payment incentives and takes the next logical step “in promoting higher quality care for Medicare beneficiaries and transforming Medicare into an active purchaser of quality health care for its beneficiaries.” The Hospital VBP program now directly ties payment amounts to a hospital’s performance score. CMS will begin measuring hospital performance for incentive payments this July.
To fund the Hospital VBP incentive program, CMS will reduce the base operating diagnosis-related group (DRG) payment by 1% in FY 2013 and increase withholding by 0.25% each year until it peaks at 2% in FY 2017. As a result, approximately $850 million will be allocated for the Hospital VBP program in FY 2013. Since overall Medicare spending for inpatient stays at acute care hospitals will remain constant, the new payment scheme will benefit some hospitals and hurt others. As the Hospitalist writes, “[i]t’s also a zero-sum game. That means there will be winners and losers, with the entire cost-neutral program funded by extracting money from the worst performers to financially reward the best.”
How It Works
As summarized by our very own Kate Greenwood:
[§ 3001(a)], which applies to patients discharged on or after October 1, 2012, establishes “value-based purchasing,” meaning that the government will make “value-based incentive payments” to hospitals that provide care to Medicare patients that meets or exceeds certain performance standards to be established by the Secretary of Health and Human Services. Initially the standards must relate to at least the following five conditions: heart attack, heart failure, pneumonia, surgery, and healthcare-associated infections. Eventually (by fiscal year 2014) the standards are to incorporate “efficiency measures,” that is Medicare spending per beneficiary must be a factor.
Beginning in FY 2013 (October 1, 2012), hospitals will receive incentive payments “based on how well they perform on each measure or how much they improve their performance on each measure compared to their performance on the measure during a baseline performance period.” The final rule adopts twelve clinical process of care measures and one patient experience measure, the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey. These measures overlap or align with the Hospital Inpatient Quality Reporting (IQR) Program measures.
FY 2013 Objective Measures
Acute Myocardial Infarction
|AMI-7a||Fibrinolytic Therapy Received Within 30 Minutes of Hospital Arrival|
|AMI-8a||Primary PCI Received Within 90 Minutes of Hospital Arrival|
|PN-3b||Blood Cultures Performed in the ED Prior to Initial Antibiotic Received in Hospital|
|PN-6||Initial Antibiotic Selection for CAP in Immunocompetent Patient|
|SCIP-Inf-1||Prophylactic Antibiotic Received Within One Hour Prior to Surgical Incision|
|SCIP-Inf-2||Prophylactic Antibiotic Selection for Surgical Patients|
|SCIP-Inf-3||Prophylactic Antibiotics Discontinued Within 24 Hours After Surgery End Time|
|SCIP-Inf-4||Cardiac Surgery Patients with Controlled 6AM Postoperative Serum Glucose|
Surgical Care Improvement
|SCIP-Card-2||Surgery Patients on a Beta Blocker Prior to Arrival That Received a Beta Blocker
During the Perioperative Period
|SCIP-VTE-1||Surgery Patients with Recommended Venous Thromboembolism Prophylaxis Ordered|
|SCIP-VTE-2||Surgery Patients Who Received Appropriate Venous Thromboembolism Prophylaxis
Within 24 Hours Prior to Surgery to 24 Hours After Surgery
In FY 2014, CMS will add thirteen more measures.
FY 2014 Objective Measures
Acute Myocardial Infarction
|Mortality-30-AMI||Acute Myocardial Infarction (AMI) 30-day Mortality Rate|
|Mortality-30-HF||Heart Failure (HF) 30-day Mortality Rate|
|Mortality-30-PN||Pneumonia (PN) 30-Day Mortality Rate|
Hospital Acquired Condition Measures
|Foreign Object Retained After Surgery|
|Pressure Ulcer Stages III & IV|
|Falls and Trauma: (Includes: Fracture, Dislocation, Intracranial Injury,
Crushing Injury, Burn, Electric Shock)
|Vascular Catheter-Associated Infections|
|Catheter-Associated Urinary Tract Infection (UTI)|
|Manifestations of Poor Glycemic Control|
AHRQ Patient Safety Indicators (PSIs),
|Complication/patient safety for selected indicators (composite)|
|Mortality for selected medical conditions (composite)|
Hospitals will be scored according to achievement (compared to all other hospitals) and improvement (over each hospital’s baseline) for each applicable measure. Achievement points will be awarded if the hospitals performance during the measurement period (quarterly) exceeds the 50th percentile of hospitals measured during the baseline period (the “threshold”). Improvement points will be awarded to the extent that a hospital’s current performance exceeds baseline period performance.
Baseline scores for improvement measurement have already been set, during the period from July 1, 2009 to June 30, 2010. The FY 2013 performance period for clinical process of care measures will be July 1, 2011 through March 31, 2012. July 1, 2011 will also mark the beginning of a 12-month performance period for the FY 2014 30-day mortality measures.
The Total Performance Score (TPS) is calculated “for each hospital by combining the greater of its achievement or improvement points on each measure to determine a score for each domain, multiplying each domain score by the proposed domain weight and adding the weighted scores together.” In 2013, clinical measures will account for 70% of a hospital’s performance score and the HCAHPS survey for 30%. Over time, scoring methodologies will be “weighted more heavily towards outcome, patient experience, and functional status measures.”
Moving forward, CMS will implement other ACA provisions designed to improve care and reduce costs. For instance, hospitals will begin receiving reduced payments in FY 2015 if they are unable to prevent certain hospital acquired infections or if the hospital fails to “meaningfully use information technology to communicate within the hospital to deliver better, safer, more coordinated care.” Check prior posts to learn more about HITECH’s “Meaningful Use” Rule.
Inspired to act to reduce maternal mortality after she survived a postpartum hemorrhage, renaissance woman Christy Turlington has been making the rounds promoting her documentary No Woman No Cry, which tells the stories of at-risk pregnant women in Bangladesh, Guatemala, Tanzania, and the United States. If you have been in a Starbucks lately you may have seen the compilation compact disc of the same name, the proceeds of which support the advocacy organization Turlington founded, Every Mother Counts. As Turlington writes, “almost all of the hundreds of thousands of maternal deaths that occur each year are preventable. Yes, 90 percent!”
While the developing world bears the brunt of the global burden of maternal mortality and morbidity, the United States is not immune. Women in 49 other countries have a better chance of surviving childbirth. Passage of the Maternal Health Accountability Act of 2011, which was introduced by Representative John Conyers (D-MI) on March 3, 2011 and is currently pending in the House Committee on Energy and Commerce’s Subcommittee on Health, would be an important step towards redressing the problem of maternal mortality and morbidity here at home.
Among other things, the Act would provide funds to states to improve the reporting and tracking of pregnancy-related deaths. In a recently-released report, the Council of State and Territorial Epidemiologists noted that maternal & child health “is the one program area in which overall state-level epidemiology and surveillance capacity increased progressively from 2004 to 2009, bucking the trend of an overall decrease in state-level epidemiology capacity.” On the other hand, “the MCH epidemiology capacity glass is only half full: nearly half of all states lack even substantial MCH epidemiology and surveillance capacity, and in only a minority of jurisdictions do MCH epidemiologists participate substantially in policy development; have access to important data sets; and work with colleagues in substance abuse, mental health, and occupational health.”
The Maternal Health Accountability Act would also direct the National Institutes of Health to “organize a national workshop to identify definitions for severe maternal morbidity and make recommendations for a research plan to identify and monitor such morbidity in the United States.” As the Act’s findings section explains, “[s]evere complications that result in women nearly dying, known as a ‘near miss’ or severe morbidity, according to some estimates, increased by 25 percent between 1998 and 2005, to approximately 34,000 cases a year. However, there is no scientific consensus on uniform definitions of severe maternal morbidity and best practices for data collection, making it difficult to measure the full extent of severe morbidity and developing evidence-based interventions.” Finally, the Act would direct the Secretary of Health and Human Services to conduct research and establish demonstration projects targeting the stark geographic, racial, and socioeconomic disparities in maternal health outcomes. According to Amnesty International’s Spring 2011 Deadly Delivery report, “[n]ew government data shows that for 2005-2007, the maternal mortality ratio (deaths per 100,000 live births) was highest among non-Hispanic black women (34.0), followed by American Indian/Alaska Native women (16.9), Asian/Pacific Islanders (11.0), non-Hispanic whites (10.4), and Hispanics (9.6).”
Importantly, tackling the problem of maternal mortality and morbidity need not wait until Congress acts. In an article in the April issue of the American Journal of Obstetrics & Gynecology, Hospital Corporation of America, a chain of 114 inpatient facilities that claims to be the “largest obstetrical health care delivery system in the United States,” reported on its highly-successful obstetric patient safety program. Among other things, HCA expanded the number of free, online programs it offers on topics such as fetal heart rate monitoring, postpartum hemorrhage, and shoulder dystocia, with the goal of educating providers and ensuring that they use “common terminology and thus avoid potentially hazardous miscommunication.” In addition, HCA engaged in process standardization efforts including the development of checklist-based protocols and supported the development of national quality metrics to facilitate benchmarking. HCA has been effective at reducing elective delivery before 39 weeks gestation and it “instituted a policy of universal perioperative pneumatic compression device use in all patients undergoing cesarean delivery.” (I discussed the latter intervention here.) HCA reports that its efforts have paid off, not just in outstanding perinatal outcomes, but also in reductions in litigation, as reflected by reported claims. In 2009, the company’s losses due to “accidents on hospital grounds” exceeded its losses due to maternal mortality and morbidity. Even more impressive, its “perinatal loss (in dollars) … is rapidly approaching the level of loss seen in the category ‘occupational therapy.’”
HCA opines “that adoption of our approach on a national level could, within 5 years, both dramatically reduce adverse perinatal outcomes and to a large extent eliminate the current national obstetric malpractice crisis. In reality, a relatively small number of repeated errors lead to most preventable adverse outcomes, and may be reduced by the approaches outlined above.” The company is not optimistic that its approach will be widely adopted, however, because it believes that efforts to improve perinatal outcomes have been hindered by “an alternative culture in which physician autonomy and anecdotal experience trump available data and the recommendations of the Institute of Medicine, contributing to a ‘normalization of deviance’ at odds with a safety-based culture.” I wonder how physicians would respond to this interesting and provocative claim. Might they argue that hospital policies and practices are at least in part to blame for our stalled efforts to reduce maternal mortality and morbidity?
Lucia Burgos sued Satiety, Inc. after an experimental stomach stapling device perforated her esophagus. Her first complaint was dismissed on preemption grounds, but she was given permission to “replead her claims as state-law parallel claims.” So called “state-law parallel claims” are state law tort claims where the duty that the defendant manufacturer is alleged to have violated stems from the Food Drug & Cosmetic Act or its implementing regulations. Such claims are not preempted because they do not impose additional duties on defendants, beyond those imposed by Congress and the Food & Drug Administration.
Ms. Burgos amended her complaint to state two new claims, including a state law negligence cause of action founded on Satiety’s alleged failure to manufacture the device in conformance with the requirements of its investigational device exemption (IDE). Ms. Burgos believes that it was the device (as opposed to human error) that caused her injury because of an incident report filed by her treatment team, but, because the documentation supporting the FDA’s grant of an IDE is confidential, her complaint does not specify how the device deviated from the IDE. On April 5, 2011, Judge John Gleeson of the Eastern District of New York held that Ms. Burgos had stated a claim for negligence and that, despite the lack of specifics, her suit could proceed “to a brief and strictly-cabined period of discovery in order to determine the terms of Satiety’s IDE, and to explore whether or not the specific device used in her procedure was manufactured in accordance with the IDE.”
The Burgos case is of interest to civil procedure buffs because of what the BNA Medical Research Law & Policy Report characterized as Judge Gleeson’s “liberal approach” to the pleading of parallel claims, but it is important to the rest of us, too, because of what it tells us about the state of the products liability backstop to FDA’s oversight of medical devices. In the words of Ms. Burgos’ attorney, there is only a “narrow window” for parallel claims.
The limited recourse that those injured by medical devices have in court makes the FDA’s pre-market clearance and approval processes and its post-market surveillance and recall oversight efforts that much more important. Testimony given earlier this month by Marcia Crosse, Health Care Director at the Government Accountability Office, before the Senate’s Special Committee on Aging suggests that there is cause for concern. As Ms. Crosse explained, in January 2009 the GAO issued a report in which it “found that a significant number of high-risk devices-including device types that FDA has identified as implantable; life sustaining; or posing a significant risk to the health, safety, or welfare of a patient-were cleared for the U.S. market through FDA’s less stringent 510(k) review process.” Section 510(k) of the FD&C Act allows for streamlined review and clearance of devices that are shown to be substantially equivalent to devices already on the market. Data from clinical trials is typically not required to make this showing.
The FDA agreed with the GAO’s 2009 recommendations. If the devices at issue did not actually belong in the highest-risk class, Class III, they should be re-classified. On the other hand, if they did belong in Class III, they should be subject to the more stringent premarket approval process, which typically requires clinical data in support of an agency determination that a device is safe and effective for its intended use. In her testimony, Ms. Crosse noted that, to date, the FDA has issued a final rule reclassifying one device — a blood test for herpes — from Class III to Class II. Rules regarding the classification of another five devices are pending. “There are still 26 types of high-risk devices, including, for example, automated external defibrillators and implantable hip joints, that can enter the market via 510(k).” Moreover, since January 2009, “FDA cleared at least 67 individual submissions that fall within 12 of these class III device types through the 510(k) process.”
While the GAO has not completed its review of the FDA’s post-market activities, Ms. Crosse testified that their “preliminary findings suggest that shortcomings in FDA’s oversight of the medical device recall process may limit the agency’s ability to ensure that the highest-risk recalls are being implemented in an effective and timely manner. These shortcomings span the entire range of the agency’s oversight activities-from the lack of a broad-based program to systematically assess trends in recalls, to inconsistencies in the way FDA ensures the effective completion of individual recalls.”