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 50^th 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 2^nd, 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.

Recommended Reading: Recent Scholarship with Implications for Pharmaceutical Pricing and Access

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.”

Medical Malpractice Settlement Negotiations: Early and Often in the Bronx

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.

Glaberson writes:

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.

Review of Reconsidering Law and Policy Debates: A Public Health Perspective

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.

Veterans and Mental Health Care, The Court Speaks

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.

Final Value-Based Purchasing Rule Released

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
Heart Failure
HF-1	Discharge Instructions
Pneumonia
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
Healthcare-associated Infections
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
	Air Embolism
	Blood Incompatibility
	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), Inpatient Quality Indicators (IQIs), and Composite Measures
	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 50^th 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.”

Future Changes

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.

Mother’s Day Maternal Health Update

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?

Left to Our Own Devices?

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.”

“The King Has No Clothes!” and Other Useful Truths in the Health Care Setting

Two recent  articles in the Wall Street Journal’s Health Blog are well worth considering. The one article discusses the efficacy of the “aviation model” for medical practice safety. Noting that the surgical checklist is itself cockpit inspired, the article considers a report which questions whether other aviation safety models might be also effective in a health care setting. WSJ writes:

A paper published recently in the Milbank Quarterly, a peer-reviewed population-health and health-policy journal, suggests extracting even more lessons from the aviation world, offering 15 examples of error-reduction policies that aren’t always routinely used in the health-care setting.

The surgical checklist has proved effective. In a post entitled Surgical Checklist Said to Save Lives & Money, we noted the following:

The use of a basic checklist was shown to be associated with a substantial decrease in surgical deaths and complications. In what the A.P. referred to as a “a large international study of how to avoid blatant operating room mistakes,” researchers found a 47 per cent decrease in death and a more than one third decrease in complications-from 11% to 7%- concomitant with the use of a 19 point checklist designed by the World Health Organization.

A few aviation examples the WSJ noted in the article mentioned above involve communication and they, I believe, are worth considering for a moment:

The “sterile cockpit” rule. During certain critical phases of flight, pilots and crew aren’t supposed to chat idly or do anything else not essential to their jobs. Similarly, nonessential activities might be prohibited during certain phases of medical practice, which would depend on the practice (incision during surgery, for example.)

First-names only rule. Regardless of rank or seniority, cockpit personnel address each other by their first names in order to “flatten the social hierarchy” and “foster a culture in which colleagues feel more comfortable questioning one another,” the authors write. Doing the same for surgical or medical teams might promote a similar culture, though the issue is made “complex” by the fact that patients prefer “formality” in their relationships with their doctors.

These examples, much like the surgical checklist, stand out for being common sensical and one would imagine, relatively easy to implement.

Anyone involved in a moderately complex task should be able to relate to the benefit of a “no chatter zone” during the portions of the task which require greater concentration or present greater risk or more dire ramifications. Much of what I do on any given day, because I do it so often, is largely rote. But some moments are crucial; it helps to then not be listening to a co-worker recount the latest misadventure involving cute children, a puppy and some potato salad.

The First-names only rule is perhaps a bit more attenuated, but perhaps even more important. People make mistakes; it is crucial that one has colleagues or friends willing to point them out. The failure to be informed of one’s own errors can have critical impact. History and literature are filled with examples. Think of King Lear and his Fool–someone at court able to tell the King the truth– lest the ruler find himself, like that other famously fabled King, parading through town without clothes. A more modern, and real, example is President Kennedy, his Cabinet and the Bay of Pigs fiasco–a room full of men who thought better but engaged in “groupthink” to the point that they ultimately functioned as rubber stamp sycophants to the President– keeping their misgivings to themselves. After the disaster which was the Bay of Pigs, Kennedy removed himself from Cabinet meetings to allow his counsel to do just that. And for the boxing afficianado (boxing is not sport so much as life distilled– Classical Tragedy, with only the how and when to be resolved) it is an oft repeated tale in which after years of hard and driven work with a dedicated trainer a new Champion with new money is found by new friends–or “hangers-on” as they are most often called in the trade. These omnipresent “friends” with no visible means of support beyond the boxer tend to say things like “You’re right Champ” and  ”You’re the Champion Of The Entire World! You don’t have to train if you don’t want to.” The results are often brutal in their reckoning. Ask Mike Tyson.

But in a more recent article, “Report: Communication Breakdowns Lead to Hospital Errors,” the Wall Street Journal gives us other cause for concern–more concrete, more direct to the topic at hand. The Journal writes:

According to a two-pronged survey of operating-room and critical-care nurses conducted by their professional associations and VitalSmarts, a global training and consulting firm, 85% of 2,383 nurses surveyed said they’d been in a situation where measures put in place to reduce errors -  including checklists or hand-off protocols - warned them of a problem that would have otherwise harmed a patient.

That’s the good news. The bad is that 58% of the nurses said they’d been in situations where it was “either unsafe to speak up or they were unable to get others to listen.”

The report focuses on what causes this type of communication breakdown, including three concerns that are rarely discussed by health-care teams: dangerous shortcuts, incompetence and disrespect. Among respondents to a separate survey of 4,235 nurses, 84% reported working with people who take potentially dangerous shortcuts, such as not washing hands for long enough, with 34% saying shortcuts had led to near misses and 26% saying they caused harm to patients. Some 19% say incompetence or lack of required skills have harmed patients and 20% say that disrespect is making them seriously consider leaving their profession.

Despite all this, concerns “are often left undiscussed,” the report says.

Do I Need 9 Lives Just to Get a Cat Scan?

Tonight’s post will be relatively brief, as I wish only to call attention to another post and a particularly disturbing number contained therein. The post was published over at The Health Care Blog by Robert Wachter, MD, a leading figure in the modern patient safety movement. It is entitled “A Game-Changing Statistic: 1 in 250.” It is. Or at least it should be. You should take a minute or two to read it– it’s provoking, and not in a good way.

The 1 in 250 refers to the odds of getting cancer from a single CT scan.

Wachter writes:

Last month, my colleague Rebecca Smith-Bindman, professor of radiology, epidemiology, and ob/gyn at UCSF and one of the nation’s experts in the risks of radiographs, gave Medical Grand Rounds at UCSF. Her talk was brimming with amazing statistics, but this is the one that took my breath away:

A 20-year old woman who gets an abdominal-pelvic CT scan (i.e., just about any young woman coming to the ED with belly pain) has a 1 in 250 chance of getting cancer from that single scan.

Did that fully register? One CAT scan, which until recently most of us ordered with no more restraint than we exhibit when asking the Starbucks barista for a tall latte, will cause cancer in one out of every 250 patients. Two-hundred fifty: that’s the number of students in my college Bio 101 class. Wow.

Wachter adds fuel to that disturbing fire and reports that his above mentioned colleague found both increased radiation dosage (66% greater than that which is the usually quoted dose) and wide variation in dosage among different scanners in 4 Bay area hospitals.

If the variation and increased dosage isn’t scary enough, perhaps this nugget from Wachter regarding the usual dose is:

• A multiphase abdominal/pelvic CT scan has the same radiation wallop as 500 transcontinental flights, 450 chest radiographs, and 74 mammograms.

The effects? Well, there’s the 1 in 250 number, but Wachter is kind enough to give us an aggregate estimate:

• The best estimates are that radiation from CT scans causes 29,000 excess cancers each year in the U.S., mostly in women.
• Researchers estimate that 15,000 people will die from the direct effects of the 72 million CT scans performed in 2007 alone.

And if that weren’t enough, it seems the death and danger are accompanied by widespread ignorance–

• A 2004 study found that less than 50 percent of radiologists, and 9 percent of ER docs, were aware that CT scans could increase the subsequent risk of cancer.

Unfortunately, quite a few CT scans are done each year. And the number has risen dramatically over the last few decades–a more cynical man (or perhaps just a man who has read Atul Gawande and Adam Smith) might think the increase in usage might bear some relationship to the high cost of purchase for a CT scan machine-Buy it and they will come. Wachter tells us that

• One in five Americans will receive a CT scan in any given year; some experts suggest that at least one-third of those scans are unnecessary.

Even if only one-fifth were unnecessary, with a 1 in 250 chance of getting cancer from a single scan, the odds are ugly– and at least in some cases, amount to a dire risk without any merit whatsoever. In other cases, we risk greatly for minimal gain–and, perhaps, most disturbingly, that risk is often called for by doctors and radiologists who are sans knowledge of the risk. Yes,  a 1 in 250 chance of getting cancer from a single scan–when you perform 72 million of them per year–should be a game changer.

Michael Millenson on Medical Error and “Letting Children Die Unneccesarily”

Sometimes misery neither loves, nor is especially reassured by, company.  Acclaimed author and president of Health Quality Advisors LLC, Michael Millenson, recently published an article over at Health Affairs and The Health Care blog well worth considering. It’s entitled “Why We Still Kill Patients.” And no, that’s not a question.

My recent articles examining the Medicare “errors contributing to death” (at a rate of 180,000 per year according to the Inspector General of the Department of Health and Human Services, Daniel R. Levinson), and my personal experience lately and prior (Thanksgiving & Medical Malpractice), have left me less than sanguine with regard to the doctor’s art as practiced in hospitals. Granted, I wasn’t particularly sanguine before– having long held the view that before we talk about malpractice reform, perhaps we could get hospital employees to at least wash their hands.

But there’s something even more disturbing about Millenson’s article. I’ll let this portion speak for itself– though the benefit analysis of “complications” which follows is, in its own right, equally disturbing. Millenson writes:

Letting Children Die Unnecessarily

There are many examples of the inertia these beliefs produce, but one I cannot get out of my mind concerns sick children. At the 2009 AcademyHealth meeting, Dr. Richard Brilli of Nationwide Children’s Hospital presented data showing how a collaborative backed by some of the most respected organizations in pediatric care had slashed the rate of catheter-associated bloodstream infections (CA-BSIs). CA-BSIs are relatively common, very expensive and can be quite deadly (up to one quarter of victims die). Brilli said his collaborative had tried to recruit 330 pediatric intensive care units to join the initial participants, but after three years, just sixty had accepted. The reasons Brilli said he’s been given indicated to me that few had taken the time to examine the collaborative’s methodology or results. Instead, respondents asserted that their patients were sicker, their hospital was busier than the others in the study, that joining would make them look bad to others, or that the mortality reduction didn’t apply because “I am in a world famous center.”

Now fast-forward to the February, 2010 issue ^[10] of Pediatrics, in which the collaborative concluded: “CA-BSIs are a preventable cause of patient harm to critically ill children.” What you can’t see in the peer-reviewed literature is this context: at literally scores of hospitals which declined to participate in the collaborative, hundreds of sick children likely were injured or killed who probably would not have been harmed had the hospital been a collaborative member. Those harmed were tended to by dedicated staff who thought they were doing everything they could to help the kids in their care. They were dead wrong, but even today they may not know it. Certainly, their patients and the public do not.

You can find the rest of the article here.

Thanksgiving & Medical Malpractice

It is the verge of Thanksgiving and I find myself forced to consider medical malpractice again. Readers of this blog are well familiar with my stance on medical malpractice reform, which is often preceded by a disclosure that the J.D after my name means I have somewhat of a vested interest. But in addition to my ties to the law, like everyone else I have family ties as well. I’ll disclose that as well. I am both a son and a father, once a husband and a grandson, still a cousin and an uncle. And a nephew. I am 48 years old and have now lived to see serious medical malpractice up close and personal at least 4 times.

Last night I sat in a waiting room and listened to my 80 year old aunt scream and cry as her 50-something year old daughter died from a massive brain hemorrhage. I listened to my cousin’s children crying as they tried to figure out how they were going to tell their children that their “Ama” had died. I held my cousins as they cried. I held my brother. I smoked with my cousin’s husband–shellshocked, lost and aghast.  And 25 of us more or less crammed the waiting room over a period of 12 or 14 hours or so, wandering, hoping and praying that my cousin would come back from a doctor’s generally admitted error. It did not happen, and November 23rd was her last day on earth. I am an articulate man. But I do not think I can even come close to describing the pain and anguish I witnessed the last few days– or that which is to come as we prepare to bury my cousin Michelle.

A short time ago a doctor had drilled through my cousin’s skull in order to place a chemo port to treat her lymphoma– eschewing the use of a depth guide, he drilled too deep. And here we are. Again.

25 years ago I sat in a similar waiting room with the same aunt who was mourning last night and loads of other family after my 80 year old grandmother– a matriarch if ever there was one– had been hit by a car while crossing the road. After the first day, we were told that my grandmother would be fine and that she was stable and would need only an operation in a few days to fix her legs. I sat in my grandmother’s room and convinced her that although Jesus alone had fixed her in the past, that maybe sometimes God works through doctors too– and that this time they said that if she didn’t have the operation she would never walk again. We talked. I read her Bible verses. She relented. But a day before the scheduled surgery she suddenly died. From the impact of the collision, her head had swollen. When the swelling went down, a damaged blood vessel burst. The swelling had been keeping that vessel in tact. None of the doctors had thought to check. The doctor apologized; the hospital paid some small settled amount– my family too traumatized to carry on a protracted battle.

When my father passed away a few years back from an extremely rare (1 in a million), 100% fatal, organic brain disease with a sudden onset, I watched more serious errors made. By that time I was in my second year of law school.  I asked questions. I monitored. I pressed. My first battle was the day after his initial admittance with a weekend resident who was going to discharge my father with a patently erroneous and perfunctory diagnosis of Alzheimers, saying “there’s only so many tests we can run.” This despite the sudden onset of his symptoms, a number of which do not occur in Alzheimers. I won, he stayed– and he puzzled physicians of every stripe for weeks. The next error revolved around one doctor telling others that a very important portion of a series of tests had been run when they had not. The tests, measuring particular proteins and antibodies, would determine whether my father had something about as rare, which presents in a manner very similar to the 100% fatal disease, but can be treated– if caught promptly–by, believe it or not– steroids. Forced to prove the error to the neuroscience team at a conference table with the hospital liaison seated, I did. It was arduous, the chief of neurosurgeon nearly choked on his own hubris, and I received an apology, while my father received the omitted portions of the critical tests.

The results of the test were not what we had hoped for, and my father passed away around two weeks later. But that, I suppose, is not the point. Had he had the much hoped for disease which can be treated with steroids, and had I not discovered the omission and false reporting, my father would have lost his life from a treatable disease due to a wrong diagnosis and a failure to treat– along with a false report.

About 15 years ago my wife at the time bled heavily after a same day gynocological procedure. I contacted the doctors office and explained in detail the situation to the doctor’s receptionist because “the doctor was busy” and would not come to the phone. The doctor relayed through the receptionist that my  wife should take pain pills and relax. I  stressed again the severity of the bleeding and the pain. I was dismissed again out of hand– until I told the receptionist that she should tell that doctor that she had better be very sure of this diagnosis she had just made over the phone because if she’s wrong– and I somehow lost the mother of my children on account of it– I would take every single thing she owns– not because I want them– but because I would live to make her pay. The doctor agreed to see my wife, which was fortunate– because she had hemorrhaged, but lived.

Which is more than I can say for my cousin.

Last week I wrote a post here derived from an HHS study on medical mistakes. Largely taken from an article by the Inspector General of the Department of Health and Human Services, Daniel R. Levinson,

Physicians determined that about one in seven patients (13.5%) experienced at least one serious instance of harm from medical care that prolonged their hospital stay, caused permanent harm, required life-sustaining intervention, or contributed to their deaths. Projected to the entire Medicare population, this rate means an estimated 134,000 hospitalized Medicare beneficiaries experienced harm from medical care in one month, with the event contributing to death for 1.5%, or approximately 15,000 patients.

That’s per month. Some quick math will give us the yearly death figure: 15,000 x 12 months = 180,000 per year. And that’s just Medicare patients.

The “seriously harmed” equals 1,608,000 per year. Again, just Medicare.

Rest in Peace Michelle

Medicare, Hospitals, Serious Harm and Death

The Inspector General of the Department of Health and Human Services, Daniel R. Levinson, published an Op-ed in USA Today that is well worth considering.  The column, entitled “Medical mistakes plague Medicare patients,” speaks volumes. Levinson writes:

Today’s hospitals are modern-day marvels of healing, and we expect them to be models of patient safety as well. But a just-released report from my office shows that medical care is falling short for too many hospitalized Medicare patients. A decade after an Institute of Medicine study placed preventable medical errors among the leading causes of death in the United States, our latest study found that a disturbing number of hospitalized patients still endure harmful consequences from medical care, 44% of them preventable. These instances, which the report calls “adverse events,” include infections, surgical complications and medication errors

Such occurrences are not always preventable, particularly since many Medicare patients are elderly and have complicated health problems. But enough patient harm is avoidable to make a strong case for action. Hospitals must improve, but they need the help of lawmakers, medical professionals and patients to do so.

We’ve written about this issue before here on HRW (in the context of various calls for medical malpractice reform as part of health care reform and studies that show hospital staff neither washing their hands regularly nor utilizing the simple but effective surgical checklist). The Institute of Medicine study Inspector General Levinson referred to estimated 98,000 deaths per year. Last year I wrote:

Bloomberg reports that “The U.S. Institute of Medicine found a decade ago that medical errors kill 98,000 Americans a year” according to Les Weisbrod, president of the Washington-based trial lawyers’ group, the American Association of Justice.

According to Medical News Today, the medical error fatality figures above were supported by “Dr. Chunliu Zhan and Dr. Marlene R. Miller in a research study published in the Journal of the American Medical Association (JAMA) in October of 2003. The Zhan and Miller study supported the Institute of Medicine’s (IOM) 1999 report conclusion, which found that medical errors caused up to 98,000 deaths annually and should be considered a national epidemic.

A study by HealthGrades found more than twice that number in “potentially preventable deaths.”

And now this study. Look at the numbers; they aren’t pretty–and they cast some present doubt on the 98,000 number if one considers the rubric, “contributed to their deaths.” Levinson writes:

Errors prolonged hospital stays

This study began in response to a congressional mandate to determine the number of harmful medical events Medicare patients experienced, and the cost to taxpayers. My office arranged for physician reviewers to examine a random sample of 780 Medicare patients discharged from hospitals around the country during the month of October 2008.

Physicians determined that about one in seven patients (13.5%) experienced at least one serious instance of harm from medical care that prolonged their hospital stay, caused permanent harm, required life-sustaining intervention, or contributed to their deaths. Projected to the entire Medicare population, this rate means an estimated 134,000 hospitalized Medicare beneficiaries experienced harm from medical care in one month, with the event contributing to death for 1.5%, or approximately 15,000 patients.

That’s per month. Some quick math will give us the yearly death figure: 15,000 x 12 months = 180,000 per year. And that’s just Medicare patients.

The “seriously harmed” equals 1,608,000 per year. Again, just Medicare.

Levinson continues:

Strikingly, medication errors factored in more than half the patient fatalities in our sample, including use of the wrong drug, giving the wrong dosage, or inadequately treating known side effects. Such events were commonly caused by hospital staff diagnosing patients incorrectly or failing to closely monitor their conditions.

Less serious harm also occurred. An additional one in seven hospitalized Medicare patients experienced temporary problems, such as allergic reactions or injuries from falls. And many experienced multiple events, including an elderly heart patient who had six separate events during a single hospital stay. Obviously, this situation is unacceptable — and expensive, costing taxpayers more than $4 billion a year due to the need for additional treatment or longer hospitalizations (and even more if you add costs for follow-up care).

I’ve said it before and I’ll say it again. “Seemingly, one would define “defensive medicine” as that which a doctor [or hospital] does, which he or she would not do, if solely exercising his or her [or its] discretion without the fear of being sued. Therefore, might I suggest that “defensive medicine” is only excessive if the doctor’s [or hospital's] best estimation of the situation is correct.”

You can read the rest of Inspector General Levinson’s Op-ed here. He offers some direction– much needed direction.

Orszag Proposes Evidence-Based Standards for Malpractice Reform

On October 20, the New York Times published an op-ed piece Peter Orszag, the director of the White House Office of Management and Budget from 2009 to 2010.  According to Orszag, the threat of medical malpractice liability leads to the practice of defensive medicine and a departure from the use of evidence-based guidelines.  To correct this pattern, Orszag proposes that medical liability laws be reformed to create a safe harbor for physicians who follow evidence-based guidelines.  Let’s break it down.

Defensive Medicine

Orszag posits that “too many doctors order unnecessary tests and treatments only because they believe it will protect them from a lawsuit.”  But what impact to defensive spending have on the bottom line?  Researchers and economists question the financial impact of medical malpractice litigation and defensive medicine.  As the HealthReformBlog published, Bloomberg reported the following:

[A] March 2003 study by the U.S. Department of Health and Human Services that estimated the direct cost of medical malpractice was 2 percent of the nation’s health-care spending… A 2004 report by the Congressional Budget Office also pegged medical malpractice costs at 2 percent of U.S. health spending and “even significant reductions” would do little to reduce the growth of health-care expenses.

Malpractice is “a big issue for doctors but whether it’s a big issue for the American health-care system is another question,” [Robert Laszewski, an Alexandria, Virginia, consultant to health insurers and other companies], said in a telephone interview. “There are studies that indicate that medical malpractice reform would not have a huge impact on costs, but that is not what doctors think.”…

However, Orszag focuses not on the waste created from litigation, but the waste created from perceived threat of litigation.  He states, “[t]he academic literature tends to play down the role of medical liability laws in driving up health care costs. Doctors themselves, however, almost universally state that malpractice statutes lead to extraneous testing and treatment.”

Could physician fear be a larger problem than the perceived threat?  According to the same March 2003 study (as reported by Bloomberg), “defensive medical practices accounted for 5 percent to 9 percent of the overall expense.”  However, more recent research (nod to Jordan Cohen’s Reform Rodeo) reports that “annual medical liability system costs, including defensive medicine, are estimated to be $55.6 billion in 2008 dollars, or 2.4 percent of total health care spending.”

Therefore, reductions in defensive medical practices may, but will likely not, make a significant impact on health care spending.

Evidence-Based Safe Harbor

Orszag then argues, “[w]hat’s needed is a much more aggressive national effort to protect doctors who follow evidence-based guidelines. That’s the only way that malpractice reform could broadly promote the adoption of best practices.”  He explains the current problem with the law, and proposes a solution:

It is also conceivable that because [medical liability] laws usually focus on “customary practice” — that is, a doctor who has treated a patient the way most other doctors in the area would is considered safe from accusations of malpractice — they create a strong contagion effect among doctors. The laws, no matter how weak or stringent, may therefore explain why doctors in some parts of the country generally adopt much more intensive approaches than those in other areas do.

The traditional way to reform medical malpractice law has been to impose caps on liability — for example, by limiting punitive damages to something like $500,000. A far better strategy would be to provide safe harbor for doctors who follow evidence-based guidelines. Anyone who could demonstrate that he has followed the recommended course for treating a specific illness or condition could not be held liable.

This proposal raises many questions and issues with regard to implementation.

Issues of Implementation

What happens when the recommended course of treatment is inappropriate? No two patients are alike.  Feinstein & Horowitz raise the issue that “the results show comparative efficacy of treatment for an ‘average’ randomized patient, not for pertinent subgroups formed by such cogent clinical features as severity of symptoms, illness, co-morbidity, and other clinical nuances.”  In addition to the variation between patients and their unique combination of health problems, guidelines neglect to take into account patient preferences.  Also, many guidelines presuppose accurate diagnosis.

Timmermans & Mauck describe the problems associated with “cookbook” medicine put forth by critics of evidence-based medicine:

“Ironically, EBM may also result in a lower standard of safety by deskilling practitioners. Instead of using clinical judgment, practitioners will be encouraged to follow protocols that treat all patients as essentially interchangeable. Providers will therefore be poorly equipped to contend with the variations between patients they will encounter in actual clinical circumstances.”

What if the recommended course of treatment is wrong? Orszag explains the selection of evidence-based guidelines very simply.  “Organizations like the American Medical Association and the Institute of Medicine could also be called upon to issue the needed evidence-based standards for malpractice immunity.”  However, the consensus that surrounds guidelines is more complicated than that.

For instance, what if the American Medical Association and Institute of Medicine disagree over the recommended course of action?   According to David Atkins, et al., “[a]n evidence-based approach to health care policy decisions will neither eliminate controversy nor relieve policymakers of the difficult task of making decisions in the absence of clear scientific consensus… Differing values and resource constraints can produce conflict even when there is good evidence and the policy outcomes are clear.”

Additionally, Mendelson & Carino report that evidence based medicine “cannot be meaningfully practiced in the absence of good clinical studies. Lack of evidence is a major limitation of applying such principles–especially for technologies and medical practices that are not new and might not have been thoroughly tested.”

However, Orszag argues that PPACA will tackle other problems raised by critics.  For instance, Mendelson & Carino point out that “A second barrier to achieving evidence-based clinical practice is the lack of automation in the practice setting. It is unrealistic to expect doctors to be able to easily reference a clinical guideline in a busy practice setting.”  However these authors concede that the “[a]doption of computerized decision-support systems paired with EMRs have been shown to improve compliance with clinical guidelines for patients with diabetes and depression.”  Orszag believes “[s]ubsidies in the stimulus act help doctors pay for this kind of technology.”

In Conclusion…

Orszag’s proposal is intriguing, despite the questions raised regarding the effects of defensive medicine and the proposal’s implementation.  If defensive medicine is a race to the top — to see which physician can do the most to mitigate liability — any strategy to reduce waste is laudable.  Although the introduction of evidence-based guidelines as a legal standard for physicians may appear logical, there are still several hurdles to be overcome.

Petitioners Ask OSHA to Regulate Resident Physician Work Hours

On September 2, Assistant Secretary David Michaels for Occupational Safety and Health received a petition requesting that OSHA regulate resident physician and subspecialty resident physicians.  “Depending on the type of residency, physicians-in-training can work anywhere from 60 to 100 or more hours a week, sometimes without a day off for two weeks or more.”  The petition requests that OSHA exercise the authority granted under §3(8) of the Occupational Safety and Health Act to implement the following federal work-hour standard:

(1)   A limit of 80 hours of work in each and every week, without averaging;

(2)   A limit of 16 consecutive hours worked in one shift for all resident physicians and subspecialty resident physicians;

(3)   At least one 24-hour period of time off work per week and one 48-hour period of time off work per month for a total of five days off work per month, without averaging;

(4)   In-hospital on-call frequency no more than once every three nights, no averaging;

(5)   A minimum of at least 10 hours off work after a day shift, and a minimum of 12 hours off after a night shift;

(6)   A maximum of four consecutive night shifts with a minimum of 48 hours off after a sequence of three or four night shifts.

More information about the petition can be found at the Public Citizen-run website, WakeUpDoctor.org.

Present Accreditation Standards

The Accreditation Council for Graduate Medical Education (ACGME), “[a]s the accrediting body for more than 8,800 medical residency programs,… is charged with setting and enforcing standards for supervision and resident duty hours for graduate medical education.”  In 2002, OSHA denied a petition by Public Citizen, the Committee of Internists and Residents (CIR), and American Medical Student Association, citing the voluntary adoption of standards by ACGME.  In 2003, the ACGME set standards that restricted resident work hours to 80 hours per week when averaged over four weeks and no more than 30 consecutive hours of work.  (A breakdown of the differences between the OSHA petition and ACGME 2003 standards can be found here.)

In 2007, the Institute of Medicine (IOM) evaluated resident work standards pursuant to a request from Congress. The resulting report, “Resident Duty Hours: Enhancing Sleep, Supervision, and Safety” found, among other things, that considerable scientific evidence demonstrates that “30 hours of continuous time awake, as is permitted and common in current resident work schedules, can result in fatigue, and that adjustments to the 2003 rules are needed.”  In response, the ACGME proposed revised standards for resident work hours and supervision.  The comment period ended on August 9 and the changes will be implemented after July 2011.

The Substance of the Petition

According to petitioners, the ACGME revised standards are not sufficient.  A study by Landrigan et al. found that even after implementation of the ACGME’s 2003 standards:

• The average work week was 66.6 hours (95% confidence interval [CI] 66.3-66.9);
• The mean length of an extended shift was 29.9 hours (95% CI, 29.8-30);
• 29% of all work weeks were more than 80 hours in duration, 12.1% were 90 or more, and 3.9% were 100 hours or more;
• 83.6% of all interns reported hours of work in violation of the professional self-regulations that were established and are being monitored by the ACGME. This number far exceeds the rates of violations reported by resident physicians and residency programs to the ACGME, indicating both that widespread under-reporting exists, and that the ACGME’s enforcement has been ineffective.

According to the petition, these numbers of hours are among the highest in the professional world and negatively affect personal health and safety.  Despite the previous rejection of a similar petition in 2002, the petitioners have changed their strategy in appealing to OSHA:  “Whereas previous appeals to limit resident physicians’ work hours have focused on the well-documented risks patients face due to tired physicians, this petition concentrates on the often-overlooked health risks faced by the resident physicians who endure those long hours.”  These risks include:

• Motor Vehicle Accidents — In addition to anecdotal evidence that resident fatigue after long work hours has resulted in physical injury and death, the petition offered the following research:
  • A Journal of the American Medical Association (JAMA) informal survey found that “[o]f seven surgical residents in our hospitals who we interviewed, six fell asleep while driving to or from work during their internships and three were involved in motor vehicle accidents.”
  • A New England Journal of Medicine (NEJM) study found that “risk of a motor vehicle crash was increased significantly following a work shift of 24 hours or greater,” as well as the risk of a near miss.
  • Sleep deprivation researchers at John Hopkins Hospital found that “[f]orty-nine percent of resident physicians [questioned] reported falling asleep at the wheel (not necessarily at a stop light), and 90% of these events occurred after the resident physicians had worked an extended duration (> 24-hour) shift.”
  • An Anesthesiology abstract reported that 17% of survey respondents reported post-call automobile accidents and 72% reported near misses.
• Mental Health

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    Capricho No 43, "The sleep of reason produces monsters." Francisco de Goya (1746–1828)

    One study described “house officer stress syndrome.” Caused in large part by sleep-deprivation and excessive work load, physicians-in-training may suffer from (1) episodic cognitive impairment, (2) chronic low-grade anger with outbursts, (3) pervasive cynicism, (4) family discord, (5) depression, (6) suicidal ideation and suicide, and (7) substance abuse.

  • Four studies demonstrated that residents are unhappy, face high levels of stress, and suffer “major problems” in their personal relationships with others.
  • Three studies demonstrated that on-call residents reported greater mood disturbance and increased negative mood than those who were rested.
  • One study found that as many as 30% of residents experience depression during their residencies.
  • A study published in the Archives of Internal Medicine found that 21% of residents reported depressed scores on the Center for Epidemiological Studies-Depression (CES-D) scale and that depressed responses increased with longer work weeks. Two other studies also found increased rates of depression among residents that correlated with high work hours.
• Pregnancy
  • A NEJM study reported that premature labor and preeclampsia or eclampsia was twice as common among pregnant residents as the wives of male residents and that residents working more than 100 hours per week in the third trimester were twice as much at risk for preterm delivery than those that worked fewer than 100 hours.
  • The pre-term labor and preeclampsia risk was validated by a study published in Obstetrics and Gynecology.
  • One study found that infants born during residency significantly more likely to be born with intrauterine growth restriction.
• Percutaneous Injuries (such as needlestick injuries)

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    Saint Sebastian, Carlo Crivelli (1490-91)

    A JAMA study of self-reported percutaneous injuries in residents found that substantially increased risk during day shifts after overnight call as compared with day shifts not preceded by overnight call.

  • “An Annals of Surgery study from 2005 found that 20 to 38% of all procedures in one urban academic teaching hospital involved exposure to HIV, HBV or HCV.”
  • A NEJM study found that 99% of all residents had suffered a needlestick injury by their final year of study. Fatigue was the second most common reason given for the injury.

Additionally, this petition has more public support than the one submitted in 2002.  Petitioners include:

• Public Citizen, a consumer and health advocacy group with 150,000 members and supporters;
• the Committee of Interns and Residents/SEIU Healthcare (CIR/SEIU), a housestaff union, part of SEIU, representing over 13,000 resident physicians;
• the American Medical Student Association (AMSA), a national organization representing over 33,000 physicians-in-training;
• Bertrand Bell, M.D., Professor of Medicine at Albert Einstein College of Medicine and author of New York State Health Code 405 restricting resident physician work hours;
• Charles A. Czeisler, Ph.D., M.D., Baldino Professor of Sleep Medicine, Harvard Medical School;
• Christopher P. Landrigan, M.D., M.P.H., Assistant Professor of Pediatrics and Medicine, Harvard Medical School;
• Plus forty-five health-related organization and over 1,000 individuals.

Response to the Petition

In order to fulfill OSHA’s mission “to send every worker home whole and healthy every day,” the petition argues that OSHA must “act now to address the dangers that extreme work hours pose for resident physicians and subspecialty resident physicians.”

In a statement released the same day, Assistant Secretary Dr. David Michaels recognized the concerns raised by the petition:

We are very concerned about medical residents working extremely long hours, and we know of evidence linking sleep deprivation with an increased risk of needle sticks, puncture wounds, lacerations, medical errors and motor vehicle accidents. We will review and consider the petition on this subject submitted by Public Citizen and others.

The relationship of long hours, worker fatigue and safety is a concern beyond medical residents, since there is extensive evidence linking fatigue with operator error… All employers must recognize and prevent workplace hazards. That is the law. Hospitals and medical training programs are not exempt from ensuring that their employees’ health and safety are protected.

However, ACGME believes that the revised rules under development are adequate.  According to medpagetoday.com, the ACGME said the following in a prepared statement:

As the Occupational Safety and Health Administration reviews a petition from three special interest groups requesting federal regulation of resident duty hours, the Accreditation Council for Graduate Medical Education stands ready to share with OSHA the many studies, evidence, and documentation that substantiate the standards proposed by the ACGME Task Force on Quality Care and Professionalism.

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