American Journal of Law & Medicine

Managing Our Microbial Mark: What We Can Learn about Pay for Performance from Ebola's Arrival at Our Shores

The narrative of Ebola's arrival in the United States has been overwhelmed by our fear of a West African-style epidemic. The real story of Ebola's arrival is about our healthcare system's failure to identify, treat, and contain healthcare associated infections. Having long been willfully ignorant of the path of fatal infectious diseases through our healthcare facilities, this paper considers why our reimbursement and quality reporting systems made it easy for this to be so. West Africa's challenges in controlling Ebola resonate with our own struggles to standardize, centralize, and enforce infection control procedures in American healthcare facilities.

I.   INTRODUCTION
II.  EBOLA AND MRSA
     A. OUR FEAR OF EBOLA
     B. ANTIBIOTIC RESISTANCE AND MRSA
     C. THE EPIDEMIC OF HEALTHCARE-RELATED INFECTIONS
     D. EBOLA HAS SHINED A LIGHT ON PREVIOUSLY-DARK CORNERS
III. NOT EBOLA BUT MRSA IS THE DISEASE AGENT OF THE DECADE
     A. THE HEALTHCARE-ASSOCIATED INFECTIONS EPIDEMIC
     B. RECOGNIZING THE MAGNITUDE OF THE PROBLEM
IV. DEALING WITH HACS
    A. WHAT ARE HACS?
    B. IN THE UNITED KINGDOM
    C. PAY FOR PERFORMANCE?
    D. DON'T ASK, DON'T TELL: A CODE OF SILENCE
    E. WE COULD KNOW SO MUCH MORE
    F. IF IGNORANCE IS BLISS, 'TIS FOLLY TO BE WISE
V.  MOVING AWAY FROM DON'T ASK DON'T TELL
    A. HIGH-TECH MOLECULAR DETECTION
    B. CLINICAL HYGIENE
    C. WHO MEASURES PERFORMANCE? WHO DECIDES TO PAY?
    D. THE PROBLEM OF METRICS
VI. CONCLUSION

I. INTRODUCTION

The ebbing of the Ebola virus outbreak in West Africa is very good news. The incidence of new reported cases is greatly reduced, (1) and, unlike under-reported incidence numbers that have been seen in other epidemics, public health officials appear to have confidence in these reported numbers. (2) It is still difficult to say exactly which combination of domestic, international, and community efforts did the most to reduce the number of new cases. In some places, habits and customs changed faster than in others. (3) The speed at which countries were able to improve both health and sanitation, as well as education regarding both those issues, corresponded to a faster reduction in Ebola cases. (4) Those countries able to faster track both incidence and transmission from the healthcare context to the community context were able to rapidly target transmission on all fronts. (5)

This Article focuses on what is, in the big picture, a side issue: what the developed world can learn from the control of Ebola. What is true, at least in part, about control of Ebola may also apply to the epidemics the developed world faces, specifically the ongoing epidemic of healthcare-associated infections. Thus, the lessons of Ebola should be writ large on the American healthcare landscape, for example:

* that hand washing matters in disease incidence and transfer;

* that communal pressure to improve things like hand hygiene can actually make a difference, even among the less aware and less motivated;

* that Ebola needed to be brought out of the shadows before incidence and transfer could be fully addressed; and

* that reporting and reducing infectious disease incidence and transmission are intimately intertwined even while false reporting or systematic underreporting may be the norm.

This Article examines what the United States' minor brush with Ebola as compared to West Africa's much more major crisis indicates about the American healthcare system, and the United States' capacity to learn lessons from the developing world. Ebola's presence, however limited, in American acute care facilities has illuminated limitations in current infection-control procedures in American hospitals and healthcare facilities. (6) Yet little has been done to extend lessons learned from Ebola transmission to non-Ebola infectious disease control. (7)

In this way, America has more in common with West Africa than many may think.

The World Health Organization ("WHO") has argued that focusing on a single disease often disrupts health systems in the developing world. (8) Similarly, this Article argues that while focusing on one disease allows provision of specialty care for that particular disease alone, that singular focus also fails to place that disease's spread in the larger context of infection control failures in America's healthcare facilities.

The public is somewhat persuaded that the proliferation of hand sanitizer dispensers in places public and private will immunize them. (9) Thus, we alternately confront our own worst fears of a "super bug," and by doing so, push concerns about system weaknesses to the periphery, allowing us to manage to continue to participate in our communal lives. Part of a communal life includes the experiences of acute care hospitalization and nursing home residence, but these facilities are organized much as they have been for decades. (10)

And, yet, everything in our perception of infection control practices has changed with the arrival of Ebola. The organization of infectious disease control in American healthcare institutions needs to be standardized, centralized, and enforced if America is going to battle its own epidemics successfully.

When the Centers for Disease Control and Prevention ("CDC") announced that any acute care facility capable of implementing strict infection control procedures should be capable of caring for an Ebola case, (11) this announcement should have given many in infection-control circles pause. There are, and have been, significant challenges to infection-control success at United States acute-care hospitals. (12) The protocols to strictly control infections have failed. (13) Whatever caused these failings, the assertion that the issues were simple and known should have given any listener pause. Strict infection control in United States acute care facilities has not been our strong suit. (14)

Perhaps the group least informed about biology and public health are those who think the Ebola virus is naturally spread by airborne transmission. (15) Fear that we may be unable to control the spread of an infection like Ebola might be found on either end of the spectrum. (16) Those best informed about healthcare infectious disease control in American hospitals are cognizant of the astonishingly poor record for implementing infection-control protocols. (17) These two groups may share a common fear: that domestic infectious disease control practices are not up to the task, even though they may not share a common understanding of the assignment. The Ebola virus certainly makes for some interesting bedfellows.

The CDC's assertion that hospitals could manage Ebola infection highlights our need to acknowledge and manage our microbial mark if our goal is to attain a "normal, healthy microbiome" (18) in healthcare settings. The federal government is gearing up to use pay-for-performance as its lever to motivate an attack on healthcare-associated infections. (19) Yet, in the end, we will need to blur the line between the individual, clinical encounter for which performance is evaluated and pay issued, and public health's population-based approach to infectious disease control in order to succeed.

II. EBOLA AND MRSA

A. Our Fear of Ebola

West Africa's 2014-2015 Ebola epidemic provoked fear here in the United States. (20) Americans were, and still are, palpably afraid of what such epidemics may mean for the United States in a world with open borders. (21) Yet Americans are not afraid of what the first arrival of Ebola (22) might mean for our nation's hospitals, (23) where some thirty-five million people are admitted to roughly 5000 different hospitals each year. (24) Ebola has already arrived. (25) Americans are more afraid of what it might mean were Ebola to arrive in wholesale numbers. (26)

Ebola, a zoonotic anomaly, (27) can be a visually arresting killer, as it is a hemorrhagic fever. (28) The voluminous diarrhea and vomiting of Ebola victims arrests the human gaze, and provokes fear. (29)

Some of this fear is based on widespread misinformation about Ebola's transmission rate and method of transmission. (30) Almost all of this fear is steeped in ignorance about how viruses and infections mutate, (31) and some of this fear is driven by actual information about infection and bacterial transmission in hospitals in the United States. (32)

Current best estimates are that one in twenty-five patients experiences a hospital-acquired infection. (33) Those in the middle of the infectious disease knowledge continuum know enough not to fear airborne transmission, but do not know enough to fear hospital transmission. Both the most ignorant and the most knowledgeable among us are most fearful of what the large-scale arrival of Ebola in American healthcare settings (34) might lead to. (35)

Remarkably, the general public appears to have become experts on infectious disease through media coverage. Many have acquired a basic understanding or misunderstanding of how infectious diseases are spread: isolating and treating patients, and tracing and monitoring their contacts. (36) Many are so afraid that they stigmatize healthcare workers who treat Ebola patients, or those who are employed at healthcare facilities that treat Ebola patients. (37) A national debate has begun--a genuine teachable moment--about whether epidemics are best controlled at the source or by internal quarantine. (38) Inevitably, this leads to comparisons of Ebola characteristics with those of other infectious diseases. (39) But, even there, people tend to focus on diseases where epidemic-control protocols have had some success, like tuberculosis, malaria, and HIV. (40)

There is an irony to our obsession with diseases and conditions that have high visibility, despite having relatively low incidence. We focus on conditions less likely to kill Americans in large numbers than on healthcare-associated infections. (41) For every front page article in the Kansas City Star that tracked America's feared Ebola epidemic in 2014, (42) this author could locate only one article discussing healthcare-associated infections in local facilities (43) or the dangers of wide-scale bacterial infections resistant to most known antibiotics overseas. (44) Deaths from superbugs, although on a vastly larger scale than deaths from Ebola, are distinctly less florid than Ebola, often quicker, and leave a residue hidden from the human gaze, accounting for much less public interest and scrutiny.

B. Antibiotic Resistance and MRSA

Antibiotic resistance has been described as everything from "the rise of bacteria impervious to the new 'cure,'" (45) to staphylococcus aureaus ("staph") strains that are "essentially untreatable." (46) Resistance to Methicillin-resistant Staphylococcus aureus ("MRSA") specifically has been described as "the bacteria of the decade" for responding only to very advanced antibiotics that were never meant to be a first-line defense. (47) "Superbugs," (48) drug-resistant bacteria, (49) the problem of "antimicrobial resistance," (50) and the description of the modern world as living in a "post-antibiotic era" (51) are descriptors that capture an aspect of the epidemic, but few place it in its historical context.

Infectious diseases were far from unknown in the early years of the American republic. As early as 1764, the town of Swansea, Massachusetts was petitioning the legislature for ninety pounds (52) to offset "great suffrance in the smallpox." (53) Smallpox flared again in 1778 (54) producing a lively public debate about the wisdom of town sponsored smallpox inoculation. (55) New York City's 1832 cholera outbreak offers a further example (56) of early public discourse on infectious disease transmission.

The coming of antibiotics transformed bacterial infections from a scourge to a largely-manageable and successfully-managed problem. (57) But antimicrobial resistance has been developing since the very invention of antibiotics. (58) Penicillin was discovered in 1928. (59) By 1945, the New York Times quoted Alexander Fleming predicting the development of drug-resistant bacterial strains. (60) "Penicillin-resistant strains of S. aureus began appearing in hospitals just years after the drug was introduced." (61) Multiple drug resistance developed later, but was observed in Japan as early as the 1950s. (62) Since then, the race has not been to squelch bacterial infections altogether but to remain one antibiotic ahead of the ever-morphing foe.

And, for decades now, we have been one antibiotic ahead of staph infections. (63)

MRSA is a form of staph infection that does not respond to first-line antibiotics, meaning it is antibiotic resistant. (64) Some people carry staph on their skin without any danger, but these people are carriers of sorts, a status known as "being colonized." (65) The CDC estimates that one percent of the American population is colonized with MRSA. (66)

MRSA is spread by skin-to-skin contact, and its danger is activated once it enters the colonized individual's skin or someone else's skin. (67) Although we understand how MRSA can be transmitted between individuals in society, "[o]ne of the major knowledge gap[s] of infection control is the degree to which the inanimate environment ... actually drives the hospital infection process." (68) MRSA is able to live on the surface of hospital equipment for as long as nine months. (69) This means infection preventionists ought to be just as interested in how MRSA lives in a hospital as they are in how it enters the hospital. It also means that America's healthcare facilities may have an incomplete disinfection problem. Experiments with the use of ultra violet light and the use of hydrogen peroxide fogging agents have been able to reduce MRSA rates considerably (70) but both approaches take careful effort and, most importantly, substantial time.

Once the staph enters the body, it can find a home in bone, blood, joint, or organ. (71) Staph in each of these locations is a very different matter from staph present on the skin. Those with compromised immune systems are far more likely to have staph present on the skin turn into one of these diseases. (72) MRSA is a story of staph amplified from a benign skin condition to a deadly internal infection. (73)

By 2002, a strain of MRSA had been identified as resistant to Vancomycin. (74) By June 2007, the Committee to Reduce Infection Deaths ("RID") declared MRSA as endemic. (75) Although acknowledging MRSA screening as the key to MRSA control, universal screening for MRSA was delayed. (76) In retrospect, it is estimated that in the 1970s, two million Americans acquired nosocomial (77) infections and an estimated 100,000 deaths annually could be attributed to these hospital causes. (78)

Between 2008 and 2014 the CDC reported "progress" on healthcare-associated infection rates, (79) though the annual cost hovered at $9.8 billion per year. (80) Further, healthcare-associated infections were linked to higher hospital re-admission rates (81) which themselves were linked to higher mortality rates, (82) raising the question of whether hospital-acquired infections were the cause or the symptom of increased mortality.

The difference between then and now is that it is no longer clear that we are--or can--stay ahead. The multi-drug resistant infections endemic has been a long time coming. (83) But we have entered an era that might be described as one marked by "the end of antibiotics." (84) "In recent years, the rise of drug-resistant microbes has made the antibiotics we use less effective and has increased the risk that an infectious disease could get out of control." (85)

Much of the healthcare discussion of antibiotic resistance has been pharmaceutical lab focused, and, as a result, centered on understanding industrial and social forces that have drawn large pharmaceutical companies away from antibiotic discovery. (86) "Even so, treatments for some pathogens remain worryingly sparse, and the continually evolving nature of bacteria means that constant cycles of drug discovery will be necessary for the foreseeable future if medical care is to remain ahead of antibiotic resistance." (87)

The focus on an as-needed fix has necessarily precluded a "fix it first" approach targeting the sources and transmittal of bacterial infections themselves. And, the recent spread of new generation antibiotics to widespread use in the food supply compounded the pressure to develop ever more new antibiotics suitable for deployment against multi-drug resistant infections in humans. (88) Resistance to antibiotics has historically developed within three years of a product's introduction. (89) This means our human fixes must be developed at an exponentially faster pace, in an attempt to outstrip the abbreviated lifespan of each successive antibiotic fix. (90)

The biggest problem with this model of antibiotic development is that it is contrary to the financial incentives built into our drug development system. Our drug development system's financial incentives are focused on promoting drugs that will be taken for long periods of time and by large numbers of people, (91) rather than those to be taken for time-limited periods by relatively small numbers of individuals. However, those few individuals may represent the point of disease entry into the larger group. From a communicable disease perspective, this is similar to the interest we all have in seeing the relatively few Americans among us with tuberculosis receive the treatment they need, precisely so that tuberculosis case numbers remains relatively low. (92)

The new antibiotic development system design is focused on the clinical encounter when the risk to anyone can only be best understood by a public or group health analysis. Even more troubling, the relevant group for the group health analysis may extend far beyond American borders. (93)

C. THE EPIDEMIC OF HEALTHCARE-RELATED INFECTIONS

As a nation, Americans are aware of the transmission of viruses and infections. Although the country has not reached a consensus on the role of government compared to the role of free markets in promoting something as basic as better hand hygiene among food handlers, for instance, (94) there is an ongoing debate.

An entire industry built around Purell[R] and alcohol-based cleaners (95) has grown up to assuage our fears of acquiring communicable diseases and viruses in public spaces. (96) All of this occurs in the face of the fact that it is widely publicized that the problem may be with our sterilization and cleaning protocols, when "clean enough" stops being just that. (97) As Lawrence Gostin has noted, "[y]ou can't put a cellophane wrapper around a whole region and expect to keep germs out." (98) Indeed, even where the risk is not substantial, we obsess over what are popularly known as "germs" (99) or, less commonly, microbes.

Recent outbreaks of Carbapenem-resistant Enterobacteriacease ("CRE") in California attracted public attention, however briefly, about the potential for contamination of medical equipment. (100) But even there, the focus was on "inadequately sterilized medical scopes" (101) and on the surely anomalous nature of the outbreak. Eventually, the Food and Drug Administration ("FDA") asked device makers about the risk of drug-resistant bacteria outliving device maker-approved cleaning methods. (102) The agency thus acknowledged that duodenoscopes have been implicated in outbreaks at hospitals in Park Ridge, Illinois and Seattle long before the attention-rousing outbreak at Ronald Reagan U.C.L.A. Medical Center. (103) Indeed, CRE outbreaks associated with hard-to-clean duodenoscopes continue to be reported, even more recently at Cedars-Sinai Medical Center in Los Angeles. (104) But the device makers' responses were not so widely reported, nor was the FDA's recent requirement that some duodenoscope manufacturers conduct post-market research on how the duodenoscope disinfection process actually works in medical settings as opposed to in the lab. (105)

Perhaps the longer denouement of the story exceeds the attention span of the news cycle. It may also reflect an accurate assessment of actual risk. It is worth noting, though, that the underlying discussion of antibiotic resistance also fades with the fade of the focus on the outbreak. (106) We are crisis-driven in our outlook and short-sighted in our calculation of risk.

Inevitably, the question arises about how widespread the problem of health-care-associated infections is. Just as predictably, the consensus answer is that "we do not know with any certainty." (107) Moreover, we do not know whether our latest movement toward mandated reporting of things like CRE cases to the CDC is the answer, (108) or whether assigning "superbug" reporting decisions and regimens to the discretion of the states raises or reduces incidence or transmission. (109)

We are also not entirely clear on the causes of the epidemic. (110) As an epidemic without borders, healthcare-associated infections are hard to define, track, and eliminate. (111) In short, as Bernard Black and David Hyman have made clear, not all change is progress. (112)

Ebola epidemics may best be characterized as epidemics driven by poverty. (113) Our healthcare-associated infections epidemic might best be understood as an epidemic driven by wealth. (114) Ebola originated in the bush and, most probably, it leapt from fruit bats--who are lifelong hosts of Ebola as a chronic disease--to humans and primates--who serve as relatively short-lived, and therefore inefficient, hosts. (115) Ebola epidemics are thus products of war and poverty because increasing numbers of West Africans are driven to live in closer proximity to bush meat. (116)

Americans, by contrast, are increasingly estranged from our food supply, living further, physically and mentally, from the sources of our meat. (117) Americans are astonished to learn that our meat sources receive massive doses of antibiotics to promote growth as well as health. (118) And it is in the matrix created by those antibiotics that the drug-resistant superbugs of hospital-acquired infections evolve. (119) From this perspective, the Ebola story and the story surrounding healthcare-associated infections are both stories about modernity and its effect on food supply. (120)

Acknowledging the guide post of "primum non nocere" ("first, do no harm") (121) clarifies the problem of defining harm, the chances of inflicting harm, and the duty we impose on someone to minimize the risk of that harm. …

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