Infectious Diseases Telemedicine to the Arizona Department of Corrections During SARS-CoV-2 Pandemic. A Short Report.

Stephen A. Klotz MD, Krystal R. Fimbres, Lawrence D. York PharmD

Division of Infectious Diseases, University of Arizona-Tucson

Tucson, Arizona USA

Abstract

The University of Arizona infectious diseases provides telemedicine clinics to the Arizona Department of Corrections (DOC) and Pima County Jail. Beginning in January 2020 there was a sharp drop in the number of monthly consultations following the public health emergency regarding the SARS-CoV-2 pandemic. Only since ending the emergency have the number of consults risen each month to pre-pandemic numbers. However, the nature of consult requests has changed. In this report we document the change from predominately human immunodeficiency virus (HIV) consults to a broader spectrum of infectious-related issues, most noteworthy being infective endocarditis, osteomyelitis, and chronic hepatitis B and C infection, the majority of cases due to intravenous drug injection. Although the DOC and jail underwent major upheavals intramurally due to the pandemic, medical outcomes with the diseases listed above, were excellent. The telemedicine infectious diseases clinics continued to provide timely, effective care for inmates.  

Introduction

A University of Arizona telemedicine clinic for infectious diseases has been held each month for the Arizona Department of Corrections and Pima County jail since 2006. During that time as many as 16 sites within the Arizona prison system and one county jail were served by an infectious diseases specialist and pharmacist. Since the establishment of the clinic, we have consulted on thousands of incarcerated individuals (at any one time, the prison census was approximately 45,000 individuals). Until the onset of the recent pandemic, over 80% of the consultations involved HIV infection in its many stages of presentation and treatment. Beginning in January 2020 there was a sharp drop in the number of monthly consultations from 19/month to 7/month following the public health emergency regarding the SARS-CoV-2 pandemic. Only since ending the emergency have the number of consults risen to now, pre-pandemic numbers. However, the nature of consult requests has changed. In this report we document the change from predominately HIV consults to a broader spectrum of infection-related issues, most noteworthy being infective endocarditis, osteomyelitis, and chronic hepatitis B and C infection, almost all cases due to intravenous drug injection.

Methods

This is a retrospective descriptive study to characterize the number and characteristics of patients seen at the University of Arizona infectious diseases telemedicine clinics to the Arizona Department of Corrections (DOC) and Pima County Jail before, during and after the COVID-19 pandemic.

Record Review. Records of clinic visits from 2019 through April 2023 were obtained from the eMR of Banner University Medical Center, Tucson, AZ. Patient records were searched for age, sex, diagnoses, laboratory values, treatment, number of appointments, and outcomes. All patient data was de-identified.

Results

Telemedicine clinics for 2006-2020 were conducted in the University of Arizona telemedicine Program (ATP) utilizing state-of-the-art telephonic connections, cameras, and computers. It was conducted with an ATP engineer available to trouble shoot connections with the widely dispersed Arizona prison system. A separate connection was established with the Pima County Jail, which was terminated in 2021. With few exceptions a medical assistant or nurse on site controlled the camera link with the prison. The ATP clinic coordinator arranged patient visits with prison sites with Centurion, Sterling, VA through 2022 and in January 2023 onward, with NaphCare Western States Corporate Office, Las Vegas, NV. Patients were assigned to this consult clinic by physicians and nurses on site. The patients were seen in consultation for 20-30 minutes, and a clinic note entered into the medical record. Generally, laboratory values and medical records from the prison were faxed ahead of time. The telemedicine physician, pharmacist, and clinic coordinator were present during the clinic visit. However, at the start of the pandemic in January 2020, access to the hospital and University of Arizona School of Medicine were restricted and non-essential employees (including those of the ATP) were furloughed. The clinic was even cancelled on 5 occasions. Thereafter, HIPAA-compliant programs including Zoom (San Jose, CA) and eVisit (eVisit.com) were used to provide telemedicine patient care. The physician, pharmacist, and clinic director used their home computers to individually communicate with the DOC and jail.

Prior to the pandemic in 2019 there were 228 telemedicine clinic patients (19/month). That total was fairly representative of the yearly clinic visits by inmates prior to the SARS-CoV-2 pandemic. These numbers sharply declined to 7/month (307 total visits during the 40 months of the Public Health Emergency, January 2020 to May 2023). Clinic visit numbers have returned to pre-pandemic numbers only since expiration of the emergency pandemic measures. The drop in clinic numbers was undoubtedly due to a number factors including a change in prison personnel and the organizations providing medical care to the prisons. Masking of all personnel and spacing within the prison became a problem for telemedicine. It was difficult to move prisoners through cell blocks to the medical unit where telemedicine was available and some incarcerated individuals refused to attend telemedicine for this reason.

In addition to fewer patients during the pandemic, there was a change in the patients’ presenting problems. Prior to the pandemic >80% of the visits involved HIV infection, however, during the pandemic only 68 of 169 original patients (40%) had HIV infection and were seen at 213 visits (62.4% of total visits) (Table 1).

Table 1. Six most frequent diseases cared for by telemedicine clinic during SARS-CoV-2 pandemic. ^#: Human Immunodeficiency Virus; *: insufficient data provided to determine which valves were infected.

Similarly, 21 patients (12.4%) had osteomyelitis accounting for 37 total visits (12% of total visits). Of those 21 patients, 17 were admittedly or most likely associated with intravenous drug use (IVDU) while incarcerated and were cured of infection, 4 patients had chronic osteomyelitis (2 with coccidioidomycosis, 1 with diabetes and a foot infection, and one patient with congenital osteitis and recurrent infection of the inner ear). Seven patients were seen for infective endocarditis, all related to IVDU, and all judged clear of infection. The majority were infected with methicillin-sensitive Staphylococcus aureus. Ten patients were seen with hepatitis, 6 with HCV and 4 with HBV. Of those with HCV infection, all were recommended to begin therapy except one patient with cirrhosis and severe portal hypertension and hepatic cell carcinoma. All the HBV-infected individuals were controlled with nucleoside inhibitors.

Although the DOC and the jail underwent major upheavals intramurally due to the pandemic, the medical outcomes judging from the results with HIV patients were excellent. Only 1 of the 68 HIV-infected individuals seen had unaddressed resistance to anti-retroviral therapy (ART). The 67 other HIV patients, including 2 with interrupted therapy and 4 new arrivals to DOC were started on ART, demonstrated sustained viral suppression or are anticipated to do so by the next visit (thus, 98.5% achieved sustained viral suppression).

Discussion

UNAIDS has set a target of 2030 to eradicate HIV and has provided a timeline by which such an event may happen that includes diagnosing 95% of those who are infected with HIV, putting 95% of those on ART and achieving 95% viral suppression of those on ART (1). Similarly, The World Health Organization has announced plans to eliminate HBV and HCV by 2030 (2). Judging by the outcome data of our clinic even with the added stress of the recent SARS-CoV-2 pandemic, the DOC is doing their part in trying to eradicate these three diseases (Table 1). Prisoners are considered a vulnerable group at risk for 3 blood-borne viral infections, however, in the case of HIV at least, the DOC appears to be doing an excellent job in suppressing HIV even during the SARS-CoV-2 pandemic. The arrival of COVID 19 did not negatively affect the care of HIV (3).  We found this to be true as well in our experience. HBV has long been controlled within the DOC using nucleosides, but HCV treatment is only now beginning in earnest in the Arizona DOC. At present we are seeing more HCV infections monthly than other infections. From our recent experience it appears that intravenous drug injection is the greatest infectious health risk among prisoners, not tuberculosis or other communicable diseases.

Telemedicine is an excellent modality for use in consults where the physician and patient are separated by great distances, such as are the many facilities of the DOC. It is more cost-effective for the DOC to use telemedicine than transporting prisoners to brick-and-mortar clinics (4). Specialty telemedicine clinics can be scheduled and the needed medical personnel assembled on video to see the patients (5) The only downside to telemedicine to the DOC was the infrequent occurrence of an inmate who showed for consultation but important laboratory and radiology reports were not available.

In conclusion, we have found that telemedicine clinics improve drug adherence among patients with HIV and may be superior to in-person visits with respect to treating and following patients with HIV (6). In addition, we found telemedicine clinics to be useful for the diagnosis, management and treatment of severe, life-threatening infectious diseases such osteomyelitis, infective endocarditis, HIV, hepatitis B and hepatitis C infections presenting in incarcerated patients.

References

1. UNAIDS alerts countries to an unprecedented opportunity to stop new HIV infections, end AIDS and prepare for future pandemics. https://www.unaids.org/en/resources/presscentre/pressreleaseandstatementarchive/2023/may/20230524_PR_WHA_Prevention_en Accesse11 September 2023.
2. World Health Organization. Global Health Sector Strategies on, respectively, HIV, viral hepatitis and sexually transmitted infections for the period 2022-2030 (GHSS). https://www.who.int/publications/i/item/9789240053779. Accessed 11 September 2023.
3. Hanson HA, Kim E, Badowski ME. A Systematic Review: Impact of SARS-CoV-2 Infection on Morbidity, Mortality, and Viral Suppression in Patients Living With HIV. SN Compr Clin Med. 2023;5(1):144. [CrossRef] [PubMed]
4. Esmaeili ED, Azizi H, Dastgiri S, Kalankesh LR. Does telehealth affect the adherence to ART among patients with HIV? A systematic review and meta-analysis. BMC Infect Dis. 2023 Mar 17;23(1):169. [CrossRef] [PubMed]
5. Klotz SA, Jernberg JB, Robbins RA. Turn Healthcare Workers Loose with Outpatient telemedicine-Let Them Decide Its Fate; No Top-Down Decisions on What It Can and Cannot Do. Am J Med. 2023 May 23:S0002-9343(23)00341-8. [CrossRef] [PubMed]
6. Klotz SA, Chan CB, Bianchi S, Egurrola C, York LD. The Genie Is Out of the Bottle: Telemedicine Is More Effective Than Brick-and-Mortar Clinics in the Care of HIV-Infected Outpatients. Am J Med. 2023 Apr;136(4):360-64. [CrossRef] [PubMed]

Cite as: Klotz SA, Fimbres KR, York LD. Infectious Diseases Telemedicine to the Arizona Department of Corrections During SARS-CoV-2 Pandemic. A Short Report. Southwest J Pulm Crit Care Sleep. 2023;27(3):36-39. doi: https://doi.org/10.13175/swjpccs038-23 PDF

The Potential Dangers of Quality Assurance, Physician Credentialing and Solutions for Their Improvement

Richard A. Robbins, MD

Phoenix Pulmonary and Critical Care Research and Education Foundation

Gilbert, AZ USA

Abstract

The Institute of Medicine defines health care quality as "the degree to which health care services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge”. However, defining which are the desired outcomes and current professional knowledge can be controversial. In this review article the effectiveness of quality assurance is reviewed along with pointing out some of the dangers to physicians. Since deficient quality assurance can affect credentialing, solutions for the problem are offered including an independent medical staff and election rather than appointment of the chief of staff. Solutions to expedite and ensure accuracy in credentialing are offered including use of the Interstate Medical Licensure Compact (IMLC). These solutions should lead to improved and fairer quality assurance, reduced administrative expenses, decreased fraud, and modernization of physician licensing and credentialing.

Introduction

In 2013 the Southwest Journal of Pulmonary and Critical Care published a review of the history of the quality movement and quality improvement programs (quality assurance, QA) by major healthcare regulatory organizations including the Joint Commission, Institute for Healthcare Improvement, Department of Veterans Affairs, Institute of Medicine, and the Department of Health and Human Services (1). The review concluded that their measures were flawed. Although patient-centered outcomes were initially examined, these were replaced with surrogate markers. Many of the surrogate markers were weakly or nonevidence-based interventions. Furthermore, the surrogate markers were often “bundled”, some evidence-based and some not. These guidelines, surrogate markers and bundles were rarely subjected to beta testing. When carefully scrutinized, the guidelines rarely correlated with improved patient-centered outcomes. Based on this lack of improvement in outcomes, the article concluded that the quality movement had not improved healthcare. 

Nearly all quality assurance articles state that playing the “blame game” where blame a person or group of people for a bad outcome is counterproductive. However, most QA programs do exactly that (2). Physicians are often bear the brunt of the blame. Witness the National Practitioner Data Bank which is little more than a physician blacklist (3). Most QA reviews point out the importance of obtaining physician buy in of the process (2). Yet most QA programs are run by nonphysicians and overseen by hospital administrators. Not surprisingly such a process has been used as a means of controlling physicians and squelching any dissent. This manuscript was undertaken as a follow-up and to point out any potential dangers of quality assurance. It seems to reinforce the principle that “not everything that counts can be counted, and not everything that can be counted counts” (4).

New Data on Quality Assurance Leading to Improvements in Patient Outcomes

There are few manuscripts that show definitive improvement in patient outcomes and many continue to use mostly meaningless metrics. However, a recent project by the Mayo Clinic is a notable exception (5). Faced with a six-quarter rise in the observed/expected inpatient mortality ratio, physicians prospectively studied a multicomponent intervention. The project leadership team attempted to implement standardized system-wide improvements while allowing individual hospitals to simultaneously pursue site-specific practice redesign opportunities. System-wide mortality was reduced from 1.78 to 1.53 (per 100 admissions; p = .01). Although the actual plan implemented was somewhat vague, it is clear that the project was physician led and was not associated with affixing blame to any physician or group of physicians. However, it may be that the program did little more than decrease the number of admissions that were at high risk for death which can lead to reduced standardized mortality (5).

Dangers of Quality Assurance

Young physicians need to be aware of the dangers of quality assurance. Although seminal publications such as “To Err Is Human” (2) often point out that efforts to fix blame rather than analyze errors are counter-productive, experience indicates that is often what is done. Medicine is rarely practiced by a sole practitioner and should patient care result in a bad outcome, the physician least valued by administration is probably who will be blamed. I would advise young physicians to be wary of admitting any wrongdoing and seeking legal counsel when appropriate. Chiefs of staff (COS) which used to be elected from the active medical staff are now appointed and serve their administrative masters rather than the medical staff they represent in name only. Furthermore, their lack of understanding of statistics, and in some cases medicine, can make their actions dangerous. In many instances they are not interested in reasoning or explanation but in action to make the “numbers right”. Any explanation is often viewed as a mere excuse for poor performance.

Below are some examples of quality assurance being used for physician control rather than improving care. These dangers are not mentioned in reviews of QA. I personally have witnessed each and remain concerned that we perpetuate the notion that quality assurance is a positive thing that “weeds out” bad physicians. As physicians are increasingly employed by hospitals, this may become more of a problem.

Mortality

Mortality rates, especially in small population areas of the hospital are particularly subject to manipulation. For example, a small ICU might admit some patients more appropriately cared for in a hospice. If this care results in 1 or 2 excess deaths in a month because of these inappropriate admissions, the standardized mortality for a small ICU can easily rise above 1.2 (number of deaths/expected deaths) which is usually used as a cutoff for excess mortality (6,7). If 1 or 2 doctors are responsible for these patients, a superficial review might conclude that poor care resulted in the excess deaths. At the Phoenix VA we were faced with a high mortality  in the ICU. In those days the ICU was used as a hospice because of understaffing of some medicine floors making quality care for dying patients difficult. By denying admission of those patients to the ICU, we were able to reduce ICU mortality to acceptable standards (Robbins RA, unpublished observations).

Similar principles can be applied to surgical or procedure mortality. Administrators have been known to scrutinize surgical mortality or focus on complications which may or may not have arisen from the operation as excuses for replacing or restricting physicians. My personal examples include examining the outcomes of a thoracic surgeon who operated at multiple hospitals. Because one hospital wanted more operations done at their hospital, a review of surgical mortality was initiated with the idea that the physician could be replaced with a physician willing to do the bulk of their operations at the review requesting hospital.

Hospital Readmissions

Reduction in hospital readmission has been touted not only as a quality measure, but also in reducing healthcare costs. The Affordable Care Act (ACA) established the Hospital Readmission Reduction Program (HRRP) in 2012. Under this program, hospitals are financially penalized if they have higher than expected risk-standardized 30-day readmission rates for acute myocardial infarction, heart failure, and pneumonia. The HRRP has garnered significant attention. However, readmissions are sometimes quite appropriate. The HRRP has shown that readmissions have decreased but at the cost of higher mortality at least for some common conditions including pneumonia, myocardial infarction and heart failure (8,9).

Hospital-Acquired Infections

It has long been known that hospital-acquired infections are the final cause of death in many severely ill patients (10). Patients cared for several days to weeks in the ICU often develop line sepsis, ventilator-associated pneumonia, or catheter-associated urinary tract infections. How to prevent these infections is unclear (1). Nevertheless, CMS initiated the Hospital-Acquired Condition Reduction Program. With their usual definiteness, CMS announced that their program had saved 8000 lives and reduced expenditures by 2.9 billion dollars (11). However, these claims are based on extrapolated data and there appears to be no data that inpatient hospital deaths declined or that expenditures decreased. Some explanation illustrated by the following example is probably appropriate. Suppose a patient with advanced lung cancer is admitted to the ICU and intubated while awaiting chemo or immunotherapy. However, the therapy is ineffective and after 7 days the patient succumbs to an apparent ventilator-associated pneumonia (VAP). Under CMS data the patient would not die if they had not developed pneumonia which is clearly not true. This and similar extrapolations make the CMS data unreliable.

At the Phoenix VA ICU, we had a high incidence of VAP almost certainly because we were very aggressive in diagnosis. We would do bronchoscopy with bronchoalveolar lavage and quantitative cultures to diagnose ventilator-associated pneumonia (12). However, rather than our efforts being acknowledged we were threatened because our high incidence of VAP combined with our high mortality only illustrated that we were “bad” physicians according to the then COS, Raymond Chung. He brought in an outside  consultant who advised us to do tight control of glucose which would have further increased our mortality (13). We resolved the problems by decreasing the use of the ICU as a hospice as previously mentioned and by eliminating the diagnosis of VAP in the ICU. We simply quit doing bronchoscopy with BAL for diagnosis of VAP and forbade our students, residents and fellows from mentioning VAP in their notes. Our VAP rate went to zero.

Patient Wait Times

The falsification of wait times by the Department of Veterans Affairs has been well documented (14). What is less well known is that over 70% of Veterans Affairs medical centers participated in this fraud (15). What is not discussed is that VA administrators were well aware that they were falling short and assigning more patients to providers than their guidelines direct. Furthermore, when the scandal became apparent, they tried to blame long wait times on “lazy doctors” (16). At the epicenter of the wait scandal the COS at the Phoenix VA, Raymond Chung, had been aware of long wait times but kept physicians ignorant of the extent of the problem. Furthermore, in the pulmonary and critical care section the percentage of our patients waiting over 14 days was very small (<1%) and most were due to patient requests (Robbins RA, unpublished observations). However, Dr. Chung wanted to hold meetings with me to discuss the poor performance of the pulmonary and critical care section until we were started publishing our results in an email form and comparing them to other sections.

Challenging the Hospital Administration

The sad tale of how the firing of the night time janitor led to a maggot infestation at the Kansas City VA is well documented (17). What is not as well documented is what happened in the aftermath. The hospital director who fired the janitor, Hugh Doran, had already resigned from the VA because of a scandal involving him soliciting prostitution on “John TV”. However, his colleagues apparently took exception to Dr. Steve Klotz publishing his investigation of the maggot infestation in a scientific journal (18). Dr. Klotz’s Merit Review which he held for over 20 years was not renewed and he left the VA heading the HIV clinic at the University of Arizona and eventually becoming head of the infectious disease section.

Solutions

Quality assurance should be the function of an independent medical staff. Businessmen are not trained in medicine, have no practical medical experience and do not have the statistical background to determine sources of problems or the best remedies to care-related problems. The medical staff needs to be independent. A medical staff hired by the hospital most likely serves the financial concerns of the hospital administration.

Chief of Staff

The COS should be involved in the quality assurance process but only if they clearly serve the patient and the medical staff. The COS is now either appointed or approved by the hospital administration. They are no longer the doctors’ representative to the hospital administration but rather the hospital administration’s representative to the doctors. The concept that the COS can work in a “kumbaya” relationship with hospital administrators is a naive remanent of a bygone era. Although a good working relationship may exist in some healthcare organizations, the increasing numbers of suits by physicians suggests it is no longer a given that the doctors and the hospital administration work together. Furthermore, as illustrated by the examples above, the administration cannot be trusted to be fair to the individual physician.

Credentialing

Similar to QA, credentialing should be a function of the medical staff. Credentialing is the process by which the education, training, licensure, registrations and certifications, sanctions, as well as work history, including malpractice litigation, are documented and approved by the medical facility where the physician intends to provide care. In the credentialing process, many of the same documents required for state licensure are reverified; recredentialing must be periodically performed, up to every 3 years, with elements subject to change reverified. The COVID-19 pandemic has shown how that the status of our current state licensure and individual hospital credentialing procedures is unwieldly and painfully slow (19). During the pandemic various states were in desperate need of additional physicians to care for critically ill patients. Because physician licensure is by state, states had to waive this requirement to hire physicians licensed in other states. In addition, hospitals had to implement their disaster plans to streamline credentialing requirements to bring on additional physicians whether from in-state or out-of-state.

By allowing physicians licensed in one state to practice in another, and using disaster credentialing standards, NYC Health + Hospitals was able to staff up to meet urgent needs during the pandemic (20). To strengthen the ability of the US to respond to future crises, better allocate medical personnel to areas of need and also reduce administrative costs, permanent ways of enabling physicians to practice in any state are needed, such as a national physician license. The requirements for obtaining a state license are essentially the same (i.e., graduation from medical school and passage of a federal licensure test) across the country (19). Also, although there are regional differences in medical care, they are not by design. The Department of Veterans Affairs already accepts any valid state license to practice in any of its facilities (federal laws supersede state laws) and the system works well. Nonetheless, state licensure has deep roots in the tenth amendment of the Constitution, provides revenue to state governments and medical boards, and at times seeks to prevent competition from related health professions (19).

Given that a national license is not imminent, Mullangi et al. (20) have proposed a good intermediate step: build on the Interstate Medical Licensure Compact (IMLC). At present, more than 25 states have joined the compact and agreed to the same licensure requirements and to accept each other’s review of the applicants (21). If the federal government were to require all states to join the compact, a licensed physician could expediently obtain a new state license as opposed to each state medical board verifying credentials as well as other requirements).

However, even if the US had a national physician license at the time that COVID-19 hit, hospitals would still have had to invoke their disaster plans to waive usual credentialing processes and immediately employ the physicians needed to staff for the pandemic. A key obstacle with credentialing is the requirement that each entity (hospitals and insurance plans) independently verifies credentials. In practical terms, no matter how many hospitals a physician has worked in, no matter how many states in which he or she holds a medical license in good standing, no matter how many insurance plans have previously enrolled the physician, each hospital or insurance plan must independently verify the credentials. It is this redundancy that causes the long delays between when a physician accepts a position and when he or she can begin work and/or bill for services. Health care networks sharing credentialing elements among its member facilities.

A more robust method for reducing inefficiencies and increasing accountability in medical credentialing is to have a single, National source physician credentialing. At present, there are limited efforts in this direction. There are already a number of repositories to verify medical credentials in full or part including The Federation of State Medical Boards the Drug Enforcement Administration, the American Medical Association, the National Practitioner Data Bank and many credential verification organizations that will check credentials for a price to name just a few.

Implementing these proposals would not necessarily require a government subsidy. Individual physicians could pay to register in exchange for not having to submit their materials and medical education and practice histories multiple times. Hospitals and insurers could pay to access the system. Having a single national repository would not only smooth staffing burdens during either a pandemic or normal operations, but has been estimated to save more than $1 billion annually. Potentially, to be verified physicians would not even need to fill out forms with their professional information. Once their identity was confirmed, information would simply be downloaded onto a common form from the database.

Conclusions

There are numerous dangers to physicians in the QA process because the process is controlled by unqualified administrators unfamiliar with medical practice. Making QA a function of an independent medical staff rather than the hospital administration could potentially resolve many of these dangers. The COVID-19 pandemic has shown that the current US system of state licensure and hospital-based credentialing precludes the rapid hiring and credentialing of physicians. These experiences suggest solutions to more rapidly and flexibly deploy our physician workforce, decrease delays and administrative expenses, reduce fraud, and modernize physician licensing and credentialing.

References

1. Robbins RA. The unfulfilled promise of the quality movement. Southwest J Pulm Crit Care. 2014;8(1):50-63. [CrossRef]
2. Institute of Medicine (US) Committee on Quality of Health Care in America. To Err is Human: Building a Safer Health System. Kohn LT, Corrigan JM, Donaldson MS, editors. Washington (DC): National Academies Press (US); 2000. [PubMed]
3. Health Resources and Services Administration (HRSA), HHS. National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners: reporting on adverse and negative actions. Final rule. Fed Regist. 2010 Jan 28;75(18):4655-82. [PubMed]
4. Mason D. Not Everything That Counts Can be Counted. Nov 12, 2013. Available at: https://medium.com/@visualizechange/not-everything-that-counts-can-be-counted-8cdeb6deafe8 (accessed 10/16/22).
5. Mueller JT, Thiemann KMB, Lessow C, Murad MH, Wang Z, Santrach P, Poe J. The Mayo Clinic Hospital Mortality Reduction Project: Description and Results. J Healthc Manag. 2020 Mar-Apr;65(2):122-132. [CrossRef] [PubMed]
6. Pollock BD, Herrin J, Neville MR, Dowdy SC, Moreno Franco P, Shah ND, Ting HH. Association of Do-Not-Resuscitate Patient Case Mix With Publicly Reported Risk-Standardized Hospital Mortality and Readmission Rates. JAMA Netw Open. 2020 Jul 1;3(7):e2010383. [CrossRef] [PubMed]
7. Nicholls A. The Standardised Mortality Ratio and How to Calculate It. August 26, 2020. Available at: https://s4be.cochrane.org/blog/2020/08/26/the-standardised-mortality-ratio-and-how-to-calculate-it/ (accessed 9/15/22).
8. Robbins RA, Gerkin RD. Comparisons between Medicare mortality, morbidity, readmission and complications. Southwest J Pulm Crit Care. 2013;6(6):278-86.
9. Gupta A, Fonarow GC. The Hospital Readmissions Reduction Program-learning from failure of a healthcare policy. Eur J Heart Fail. 2018 Aug;20(8):1169-1174. [CrossRef] [PubMed]
10. Feingold DS. Hospital-acquired infections. N Engl J Med. 1970 Dec 17;283(25):1384-91. [CrossRef] [PubMed]
11. CMS. Declines in Hospital-Acquired Conditions Save 8,000 Lives and $2.9 Billion in Costs. Jun 05, 2018. Available at: https://www.cms.gov/newsroom/press-releases/declines-hospital-acquired-conditions-save-8000-lives-and-29-billion-costs (accessed 9/24/22).
12. Horonenko G, Hoyt JC, Robbins RA, Singarajah CU, Umar A, Pattengill J, Hayden JM. Soluble triggering receptor expressed on myeloid cell-1 is increased in patients with ventilator-associated pneumonia: a preliminary report. Chest. 2007 Jul;132(1):58-63. [CrossRef] [PubMed]
13. NICE-SUGAR Study Investigators, Finfer S, Chittock DR, Su SY, Blair D, Foster D, Dhingra V, Bellomo R, Cook D, Dodek P, Henderson WR, Hébert PC, Heritier S, Heyland DK, McArthur C, McDonald E, Mitchell I, Myburgh JA, Norton R, Potter J, Robinson BG, Ronco JJ. Intensive versus conventional glucose control in critically ill patients. N Engl J Med. 2009 Mar 26;360(13):1283-97. [CrossRef] [PubMed]
14. Oppel RA Jr, Shear MD. Severe Report Finds V.A. Hid Waiting Lists at Hospitals. NY Times. May 28, 2014. Available at: https://www.nytimes.com/2014/05/29/us/va-report-confirms-improper-waiting-lists-at-phoenix-center.html (accessed 9/30/22).
15. Office of VA Inspector General. Review of alleged patient deaths, patient wait times, and scheduling practices at the Phoenix VA health care system. Available at: http://www.va.gov/oig/pubs/VAOIG-14-02603-267.pdf (accessed 9/30/22).
16. Robbins RA. Patient deaths blamed on long waits at the Phoenix VA. Southwest J Pulm Crit Care. 2014;8(4):227-8. [CrossRef]
17. Robbins RA. Profiles in medical courage: of mice, maggots and Steve Klotz. Southwest J Pulm Crit Care 2012;4:71-7. Available at: https://www.swjpcc.com/general-medicine/2012/3/30/profiles-in-medical-courage-of-mice-maggots-and-steve-klotz.html (accessed 9/26/22).
18. Beckendorf R, Klotz SA, Hinkle N, Bartholomew W. Nasal myiasis in an intensive care unit linked to hospital-wide mouse infestation. Arch Intern Med. 2002 Mar 25;162(6):638-40. [CrossRef] [PubMed]
19. Bell DL, Katz MH. Modernize Medical Licensing, and Credentialing, Too—Lessons From the COVID-19 Pandemic. JAMA Intern Med. 2021;181(3):312–315. [CrossRef] [PubMed]
20. Mullangi S, Agrawal M, Schulman K. The COVID-19 Pandemic-An Opportune Time to Update Medical Licensing. JAMA Intern Med. 2021 Mar 1;181(3):307-308. [CrossRef] [PubMed]
21. Steinbrook R. Interstate medical licensure: major reform of licensing to encourage medical practice in multiple states. JAMA. 2014;312(7):695-696. [CrossRef] [PubMed]

Cite as: Robbins RA. The Potential Dangers of Quality Assurance, Physician Credentialing and Solutions for Their Improvement. Southwest J Pulm Crit Care Sleep. 2022;25(4):52-58. doi: https://doi.org/10.13175/swjpccs044-22 PDF 

Results of the SWJPCC Healthcare Survey

Richard A. Robbins, MD

Phoenix Pulmonary and Critical Care Research and Education Foundation

Gilbert, AZ USA 

Michael B. Gotway, MD

Department of Radiology

Mayo Clinic Arizona

Scottsdale, AZ USA

Julene R. Robbins, PhD, NCSP

Phoenix Pulmonary and Critical Care Research and Education Foundation

Gilbert, AZ USA

Lewis Wesselius, MD

Department of Pulmonary Medicine

Mayo Clinic Arizona

Scottsdale, AZ USA

Abstract

Debate is ongoing on how best to pay for healthcare, with a public option gaining increasing popularity. However, the Southwest US has traditionally been politically conservative and, although population demographics are rapidly shifting towards minorities, this shift is not reflected in the physician population. We conducted a voluntary, anonymous, on-line survey of the Southwest Journal of Pulmonary and Critical Care (SWJPCC) readership to determine if their attitudes differed from the public and/or nationwide surveys of physicians. The respondents, nearly all subspecialty care physicians, were universally consistent in their opinion that healthcare costs too much in the US. About two-thirds felt healthcare is a right. Administrative costs and insurance companies were viewed by most as the culprits for the high costs and hospital administrators and insurance company personnel were perceived as overpaid. Few viewed the electronic medical record as helpful in healthcare. These results seem mostly consistent with other Nationwide physician surveys. 

Introduction

Most Americans continue to see healthcare costs in the U.S. as a major issue, with 79% dissatisfied with healthcare costs (1). Americans who are covered by Medicare or Medicaid are the least dissatisfied (29%), while dissatisfaction is highest among the uninsured (62%) and averages 48% among those with private insurance (2). This dissatisfaction has been reflected in the current political debates with proposals including public options such as “Medicare for All”.

Physicians have also become increasingly dissatisfied with healthcare (3). A variety of factors, such as electronic medical records, income instability and fairness, and the burden of regulations have been identified as affecting physician satisfaction and each is also affected by cost (3). Surveys have reflected this dissatisfaction but none has focused specifically on the Southwest US. The Southwest is undergoing demographic shifting, particularly in Arizona, with an increasing number of minorities, especially Latinos (4). However, this changing racial and ethnic diversity is not reflected in the Southwest physician workforce, with the vast majority remaining Caucasian, although an increasing number are now women (5).

To uncover if attitudes regarding healthcare costs differ amongst the Southwest Journal of Pulmonary and Critical Care (SWJPCC) readership, we conducted an on-line survey. The results suggest that healthcare providers agree that healthcare costs too much. Furthermore, the majority favored administrative costs/insurance expenses as the predominate contributors to the increase in costs.

Methods

Survey

An experienced survey designer (JRR) constructed a survey with the goals of determining US Southwest physician attitudes towards healthcare costs and the possible causes for the high cost. Another goal was to keep the survey brief, since previous experience was that long surveys usually have a poor response. A series of 8 questions was developed (Appendix 1).

Data Collection and Statistical Analysis

Data was collected October 9, 2019 through November 27, 2019. Most results were expressed as a percentage of the responses. There were insufficient respondents between different groups (physicians, nurses, patients, etc.) to allow statistical analysis

Results

Demographics

There were 66 respondents, of which there were 61 subspecialty physicians or residents and 5 others (2 patients,1 nurse,1 technician, and 1 other). This likely reflects the readership of a pulmonary, critical care and sleep subspecialty journal such as the SWJPCC.

Healthcare Costs Too Much in the US.

There was universal agreement (all 66 respondents responding in the affirmative) that this statement is true.

Healthcare is a Right.

Forty-three of 65 responses marked this as true (66%). Twenty-two respondents felt that this statement was false (34%) and 1 with no response.

Causes for the Increase in Healthcare Costs.

The perceived causes for the increase in healthcare costs are shown in Figure 1.

Figure 1. Respondents answers for the causes of the increase in healthcare costs.

Although the answers somewhat differed, the majority felt that administrative costs and insurance companies were important contributors to increasing healthcare costs (39 of 62, 63%). None felt that physicians’ fees contributed to the increase in healthcare costs. Other responses are given in Appendix 2.

Which Healthcare Personnel Are Over- or Underpaid. 

There were 87 answers as regards which personnel are overpaid. The healthcare personnel that were felt to be overpaid are show in Figure 2.

Figure 2. Respondents answers to which personnel are overpaid.

There was consensus that hospital administrators and insurance personnel were overpaid with 78 of 87 (90%) responding that they were overpaid (multiple answers could be accepted). In contrast, only 4 respondents felt specialty care physicians, and only one each, viewed nurses and technicians as being overpaid. None felt primary care physicians were overpaid.

Answers to the question “which personnel are underpaid” mirrored the answers to which healthcare personnel were overpaid (Figure 3).

Figure 3. Respondents answers to which healthcare personnel are underpaid.

Forty-five of the 116 (39%) answers felt that primary care physicians were underpaid. A smaller number felt nurses (37 responses, 32%), technicians (26 responses, 22%), and specialty care physicians (8 responses, 7%) were underpaid. None felt that hospital administrators or insurance personnel were underpaid.

Method for Healthcare Payment

Most (65%) favored keeping private insurance but adding a public option or “Medicare for All” (15%) (Figure 4).

Figure 4. Responses to how to pay for healthcare.

Only 4 (6%) favored keeping the present system and only 2 (3%) favored mandatory managed care plans.

Innovations that Have Improved Quality in Healthcare

Innovations that were felt to improve healthcare are shown in Figure 5.

Figure 5. Innovations that have improved healthcare.

Nearly half of the 126 responses (53 responses, 42%) felt better pharmaceuticals had improved healthcare. Many also felt that internet access for medical education, such as looking up specific questions, on-line education (27 responses, 21%), and clinical decision support (26 responses, 21%) had helped. Interestingly, the most widespread innovation in healthcare in the past few years- electronic medical records- received the least support with only 5 positive responses (4%).

Discussion

This survey of readers of the Southwest Journal of Pulmonary and Critical Care strongly reflects the concern that healthcare costs too much in the US. About two-thirds of respondents felt healthcare is a right. Administrative costs and insurance companies were viewed by many as the reasons for the high costs with hospital administrators and insurance company personnel viewed as overpaid. Few viewed the electronic medical record as helpful in healthcare.

The physician opinion that healthcare costs too much is consistent with the US paying the highest cost for healthcare in the world, at over $10,000 per capita in 2017 (6). The concept that administrative costs account for much of these higher costs has only recently become widely accepted. This late realization is despite rising administrative costs highlighted by multiple articles from Woolhandler and Himmelstein, beginning with a 1991 article in the New England Journal of Medicine (7). They referred to medicine as “a spectator sport” with doctors, patients, and nurses performing before an enlarging audience of utilization reviewers, efficiency experts, and cost managers. Many physicians have watched in horror as the trend pointed out by these authors nearly 30 years ago has steadily worsened. Reports of ultrahigh CEO salaries have recently drawn some attention in both the medical and popular literature accenting the high administrative costs (8,9).

The high costs of healthcare have led to an increasing number of patients and physicians supporting a public option. Previously, physician groups, such as the American Medical Association (AMA), have thwarted public health insurance proposals since the 1930s. However, as the next generation of physicians takes on leadership roles, even groups such as the AMA are now reexamining this question (10). A March 2018 New England Journal of Medicine survey found 61 percent of 607 respondents said single-payer would make it easier to deliver cost-effective, quality health care (11). This is similar to the 80% of our readership favoring a public option. However, in our survey, most (65%) favored keeping private insurance in addition to the public option. This likely represents a physician reaction to increasing regulatory burdens by the Centers for Medicare and Medicaid Services and the Department Veterans of Affairs, two US government agencies involved in healthcare. 

Despite the changing population demographics in the Southwest US, physicians still tend to be Caucasian, although more are now women (4,5). Our data suggests that support for a public option is high among physicians. We did not ask our readers their age, although younger physicians preferentially seem to be more likely to support a public option (10). Furthermore, most pulmonary physicians are now Democrats who tend to support a public option (12). We also did not ask where the physicians practice, although it seems likely most are in the Southwest US.

Our data are consistent with other surveys, although the Southwest US and the Southern US are often viewed as the home of US conservatism. However, even though most favored a public option in our survey, there seems to be sufficient distrust of “big government” to limit the choice to only a public option (13).

References

1. Jones JM, Reinhart RJ. Americans remain dissatisfied with healthcare costs. Gallup Poll. Nov 28, 2018. Available at: https://news.gallup.com/poll/245054/americans-remain-dissatisfied-healthcare-costs.aspx (accessed 12/17/19).
2. Saad L. Four in 10 in U.S. dissatisfied with their healthcare costs. Gallup Poll. Dec 12, 2016. Available at: https://news.gallup.com/poll/199298/four-dissatisfied-healthcare-costs.aspx (accessed 12/17/19).
3. Friedberg MW, Chen PG, Van Busum KR, et al. Factors affecting physician professional satisfaction and their implications for patient care, health systems, and health policy. Rand Health Q. 2014 Dec 1;3(4):1. eCollection 2014 Winter.
4. Cárdenas V, Kerby S, Wilf R. Arizona’s demographic changes. Center for American Progress. 2012. Available at: https://www.americanprogress.org/issues/poverty/news/2012/02/28/11060/arizonas-demographic-changes/ (Accessed 12/17/19).
5. Xierali IM, Nivet MA. The racial and ethnic composition and distribution of primary care physicians. J Healthcare Poor Underserved. 2018;29(1):556-70.     [CrossRef] [PubMed]
6. Sawyer B, Cox C. How does health spending in the U.S. compare to other countries? Peterson KFF Health System Tracker. December 7, 2018. Available at: https://www.healthsystemtracker.org/chart-collection/health-spending-u-s-compare-countries/#item-start (accessed 12/17/19).
7. Woolhandler S, Himmelstein DU. The deteriorating administrative efficiency of the US healthcare system. N Engl J Med. 1991;324(18):1253-8. [CrossRef] [PubMed]
8. Robbins RA. CEO compensation-one reason healthcare costs so much. Southwest J Pulm Crit Care. 2019;19(2):76-8. [CrossRef]
9. Andrzejewski A.  Top U.S. "Non-Profit" hospitals & CEOs are racking up huge profits. Jun 26, 2019. Available at: https://www.forbes.com/sites/adamandrzejewski/2019/06/26/top-u-s-non-profit-hospitals-ceos-are-racking-up-huge-profits/#48c7a4d119df (accessed 12/17/19).
10. Luthra S. Once its greatest foes, doctors are embracing single-payer. Kaiser Health News. August 7, 2018. Available at: https://khn.org/news/once-its-greatest-foes-doctors-are-embracing-single-payer/ (accessed 12/17/19).
11. Serafini M. Why clinicians support single-payer-and who will win and lose. NEJM Catalyst. January 17, 2018. Available at: https://catalyst.nejm.org/doi/full/10.1056/CAT.18.0278 (accessed 12/17/19).
12. Frellick M. Physician specialties correlate with political affiliation. Medscape. October 12, 2016. Available at: https://www.medscape.com/viewarticle/870192 (accessed 12/17/19).
13. Robbins RA, Wang AC. Medicare for all-good idea or political death? Southwest J Pulm Crit Care. 2019;19(1):18-20. [CrossRef]

Cite as: Robbins RA, Gotway MB, Robbins JR, Wesselius LJ. Results of the SWJPCC healthcare survey. Southwest J Pulm Crit Care. 2020;20(1):9-15. doi: https://doi.org/10.13175/swjpcc074-19 PDF 

Who Are the Medically Poor and Who Will Care for Them?

Richard A. Robbins, MD

Phoenix Pulmonary and Critical Care Research and Education Foundation

Gilbert, AZ USA

Introduction

A fundamental healthcare question has been raised in the ongoing Presidential political debates-who will provide healthcare for the poor? Some are advocating “Medicare for All” while others offer other solutions. Regardless, it appears that no one is providing adequate healthcare at the moment. Go back about 60 years and there were a number of excellent public hospitals-Bellevue in New York, Cook County in Chicago, LA County in Los Angeles, Grady in Atlanta, and the aptly named Charity in New Orleans to name a few. Most were affiliated with medical schools and staffed by the medical school staff, residents and students. The poor generally received good care in those hospitals. It has long been known that academically affiliated hospitals have the best outcomes which was recently confirmed by a study from Burke et al. (1).

However, there has been some suggestion that these public (charity) hospitals might not be providing the best care to everyone. Sporadic reports have been received of patients being unable to get their breast cancer resected, not being worked up for cancer, and unable to get expensive medications, such as monoclonal antibodies for immunotherapy. This is due to lack of insurance, or denial by the insurance company or inability to afford co-payments or deductibles. What do these patients have in common? -they  are un- or under-insured, or in other words, medically poor. Apparently, the “hyperfinancializaton” of healthcare has resulted in patients with no or too little insurance unable to receive life-sustaining and appropriate care, even at a public hospital. Government was the answer in the past. Most of the large charity hospitals were locally or state funded, but with the introduction of Medicare and Medicaid in the early 1960’s, the responsibility shifted toward the Federal government. Local financial support waned as the Federal support increased (2).

The Underinsured

Of the 194 million U.S. adults ages 19 to 64, an estimated 87 million, or 45 percent, are inadequately insured (3). This is based on a definition of underinsured if the patient’s:

• out-of-pocket costs, excluding premiums, over the prior 12 months are equal to 10 percent or more of household income; or
• out-of-pocket costs, excluding premiums, over the prior 12 months are equal to 5 percent or more of household income for individuals living under 200 percent of the federal poverty level ($24,120 for an individual or $49,200 for a family of four); or
• deductible medical costs constitute 5 percent or more of household income.

This is truly a staggering number. Given that 12% of the population is uninsured, the 45% underinsured means that over half of the population is  inadequately insured during their prime working years. They can only receive the care that they can pay for, or in other words, minimal care.

Trends

One result of the Affordable Care Act has been a decline in the Nation’s uninsured. The percentage of uninsured has fallen from 20% in 2010 to 12% in 2018 (3). There have also been shorter gaps in patients’ coverage when they lose their insurance (3). However, the bad news is that more patients are underinsured. Of people who were insured continuously throughout 2018, an estimated 44 million were underinsured because of high out-of-pocket costs and deductibles. This is up from an estimated 29 million in 2010. One group likely to be underinsured is not surprisingly people who buy plans on their own through the individual market including the marketplaces. However, the greatest growth in the number of underinsured adults over this 2010-2018 period has occurred among those in employer health plans (3). These plans are increasingly shifting costs to the insured often resulting in ridiculous high deductibles or other ruses to shift costs.

Who Are the Medically Poor?

Those that cannot pay their medical bills are the medically poor. Hospital costs are notoriously hard to nail down. However, in 2005 the average cost of 2 days in the intensive care unit (ICU) in the US was $44,505 (4). Bills for prolonged illnesses could easily reach several hundred thousand dollars. Most of us rely on insurance to pay for these costs but even a percentage of the copayments may be extraordinarily high. What if the insurance decides not to pay for some reason such as the hospital is out of network, the doctors are out of network, or some other often nebulous reason? Jeff Bezos and Bill Gates are probably safe, however, what about the rest of us? In a controversial article, Sen. Elizabeth Warren and coauthors point out that medical costs significantly contribute to 60% of bankruptcies (5,6).

Personally, our family would have difficulty paying several hundred thousand dollars. We lately had a taste of this when a family member was scheduled to have a parotid tumor removed. After assuring us that the operation was covered by our insurance, the hospital where the scheduled surgery was to take place demanded $14,000 up front on the day of the operation. Fortunately, this was an elective surgery, and we were able to cancel the operation and reschedule at another hospital where the procedure was actually covered. But what if the operation was an emergency? Our family would have had little choice but to pay the money up front and then potentially be on the hook for hundreds of thousands of dollars.

Rural and Safety Net Hospitals

Recently, ProPublica ran a series on medical debt in the small rural town of Coffeyville, Kansas (7). The once bustling industrial center has suffered the plight of so many rural towns with a deteriorating economic base, declining population and a poverty rate more than double the national average. ProPublica points out that Coffeyville has a medical debt collection system where the judge has no law degree, debt collectors get a cut of the debt collection, and the medically poor can potentially be imprisoned for failing to pay their medical debts. This is probably not what community leaders envisioned when they founded the Coffeyville Regional Medical Center in 1949 and charged it with the mission “…to serve our patients and families with the highest quality healthcare”.

The ProPublica article also points out the other side of the story. The local hospital has $1.5 million in uncollected debt and the local ambulance service operates at a loss of over $300,000 per year. Most of the other small-town hospitals and ambulance services surrounding Coffeyville have closed. Nevertheless, the hospital seemed to be handling these losses until the Centers for Medicare and Medicaid Services (CMS) cut the hospital’s reimbursement by $1.4 million or about the same as the hospital’s bad debt (8). A majority of the cuts the Coffeyville Regional Medical Center come from the Trump’s administration cancellation of the Low-volume Adjustment Program for Rural Hospitals. This resulted in the hospital cutting about 30 positions mostly through attrition.

Coffeyville is not the only town with a medical center facing financial hardship. Many of the large urban medical centers mentioned earlier are “safety-net hospitals” and have also been under increasing financial pressure (9). Unfortunately, reimbursement from the Federal government has been inconsistent and payment has been difficult to predict under shifting economic and political forces.

Hyperfinancializaton

There was a time when certain aspects of society were not expected to make a profit including schools, utilities, and hospitals. It was realized that each fulfilled a special societal need. Hospitals and schools operate as not-for-profit, tax-exempt entities because of their commitment to educate and care for the public. Here in Arizona the electric companies are under the auspices of the Arizona Corporation Commission who sets their rates. However, under increasing pressure from declining tax revenues, many governments have shifted the cost burden of education, electrical power and healthcare to the private sector. With privatization comes the problem that some customers without the resources to pay are “left out in the cold”. Nowhere has that been more obvious than in Arizona. Public schools struggle while public funds are rechanneled to private charter schools; universities raise tuition and close programs because they are not profitable; private utilities shut off air conditioning when the temperature is over 100° F; and sadly, hospitals deny needed care because neither they or the patient can afford it. Public hospitals who do not deal effectively with these fiscal realities face the very real prospect of going out of business.

Summary

We must ask ourselves who will pay for the care of the poor and other basic services if not government? The private sector has apparently not been the solution and blaming inefficient bureaucrats has become an over-used cliché that obscures the basic problem of lack of funding (10). Governments and hospitals are caught with insufficient resources to provide basic healthcare services. In healthcare, a profit-driven private sector has resulted in marked price increases and pays attention to the poor only when a third-party payer reimburses the cost of care. Regardless of the specifics, the last 50 years have demonstrated that any solution that does not involve adequate government funding will not meet the goal of caring for all. However, a tax base allowing sufficient resources needs to be established. Government was the solution in the past and will need to be solution in the future.

References

1. Burke L, Khullar D, Orav EJ, Zheng J, Frakt A, Jha AK. Do academic medical centers disproportionately benefit the sickest patients? Health Aff (Millwood). 2018 Jun;37(6):864-872. [CrossRef] [PubMed]
2. Gibson RM, Waldo DR. National health expenditures, 1980. Health Care Financing Review. September 1981. Available at: https://www.cms.gov/Research-Statistics-Data-and Systems/Research/HealthCareFinancingReview/Downloads/CMS1191799DL.pdf (accessed 10/26/19).
3. Collins SR, Bhupal HK, Doty MM. Health insurance coverage eight years after the ACA-fewer uninsured Americans and shorter coverage gaps, but more underinsured. Commonwealth Fund. February 7, 2019. Available at: https://www.commonwealthfund.org/publications/issue-briefs/2019/feb/health-insurance-coverage-eight-years-after-aca (accessed 10-26-19).
4. Dasta JF, McLaughlin TP, Mody SH, Piech CT. Daily cost of an intensive care unit day: the contribution of mechanical ventilation. Crit Care Med. 2005 Jun;33(6):1266-71. [CrossRef] [PubMed]
5. Himmelstein DU, Warren E, Thorne D, Woolhandler S. Illness and injury as contributors to bankruptcy. Health Aff (Millwood). 2005 Jan-Jun;Suppl Web Exclusives:W5-63-W5-73. [CrossRef] [PubMed]
6. Himmelstein DU, Thorne D, Warren E, Woolhandler S. Medical bankruptcy in the United States, 2007: results of a national study. Am J Med. 2009 Aug;122(8):741-6. [CrossRef] [PubMed]
7. Presser L. When medical debt collectors decide who gets arrested. Propbulica. October 16, 2019. Available at: https://features.propublica.org/medical-debt/when-medical-debt-collectors-decide-who-gets-arrested-coffeyville-kansas/ (accessed 10/26/19).
8. William A. Hospital faces $1.4 million in reimbursement cuts. The Independence Daily Reporter. January 13, 2018. Available at: https://indydailyreporter.com/Content/News/News/Article/Hospital-faces-1-4-million-in-reimbursement-cuts/1/98/27613 (accessed 10/26/19).
9. Popescu I Fingar KR, Cutler E, Guo J, Jiang HJ. Comparison of 3 safety-net hospital definitions and association with hospital characteristics. JAMA Netw Open. 2019 Aug 2;2(8):e198577.[CrossRef] [PubMed]
10. Milward H, Rainey H. Don't Blame the Bureaucracy! Journal of Public Policy. 1983;3(2):149168. [CrossRef]

Cite as: Robbins RA. Who are the medically poor and who will care for them? Southwest J Pulm Crit Care. 2019;19(6):158-62. doi: https://doi.org/10.13175/swjpcc069-19 PDF 

Tacrolimus-Associated Diabetic Ketoacidosis: A Case Report and Literature Review

Stella Pak, MD¹

Megan Hirschbeck, BS²

Damian Valencia, MD¹

Victor Valencia, BS³

Yusuf Askaroglu, BS²

Dexter Nye, BS²

Adam Fershko, MD²

¹Departments of Medicine, Kettering Medical Center, Kettering, Ohio USA

²Department of Medicine, Boonshoft School of Medicine, Dayton, Ohio USA 

³Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois USA

Abstract

Post-transplant diabetes mellitus is a well-established adverse effect of calcineurin inhibitors, such as tacrolimus and cyclosporine. Failure to identify and manage this side effect in a timely manner could lead to life-threatening complications like diabetic ketoacidosis (DKA). To the best of our knowledge, this is the seventh published case of an uncommon but severe, and potentially fatal, adverse effect from tacrolimus after renal transplantation. The purpose of this case report is to add to the scant body of literature on tacrolimus-induced diabetes following renal transplantation.

Introduction

New-onset diabetes mellitus after transplantation (NODAT) is a well-established adverse effect of calcineurin inhibitors, such as tacrolimus and cyclosporine. NODAT has been reported to occur in 13.4% of patients after solid organ transplantation, with a higher incidence in patients receiving tacrolimus than cyclosporine, 16.6% and 9.8% respectively (1). Failure to identify and manage this side effect in a timely manner could lead to life-threatening complications like diabetic ketoacidosis (DKA). Currently, only seven reported cases, including this report, of NODAT with DKA exist in the English literature. This case report describes a patient who developed tacrolimus-induced diabetic ketoacidosis three months after receiving renal transplantation.

Case Description

The patient is a 44-year-old Caucasian male with no past medical history of diabetes mellitus who presented with diabetic ketoacidosis three months after receiving a deceased-donor kidney transplant for end stage renal disease secondary to autosomal dominant polycystic kidney disease. The patient’s immunosuppressive regimen included tacrolimus, mycophenolate and low dose prednisone (5 mg daily). The patient initially presented with complaints of nausea and polyuria. He did not have a family history of diabetes mellitus. Physical examination was unremarkable except for a body mass index (BMI) of 27 kg/m². Laboratory work-up revealed hyperglycemia with a glucose of 493; an anion gap metabolic acidosis with pH at 7.32 and bicarbonate at 19; significant ketosis; and ketonuria. Glycated hemoglobin (hemoglobin A1c) was 9.8 % compared to 4.8% thirty days post-transplant. Tacrolimus trough level was in the therapeutic range. Glutamic acid decarboxylase (GAD-65) autoantibodies were negative. The patient received intravenous fluids, a bolus of intravenous insulin followed by a continuous insulin infusion which was soon switched to subcutaneous insulin. Upon resolution of the patients DKA, the total daily maintenance insulin requirements were approximately 40 units. The patient received diabetic education and was discharged home.

Discussion

At the time of writing this report, there were only six reported cases of NODAT following the use of cyclosporine inhibitors such as tacrolimus which are summarized in table 1 (2-7).

Table 1. Summary of the seven reported cases focused on clinical presentation and management.

BMI: body-mass-index; M: male; F: female; BM: bone marrow; TAC: tacrolimus; MPL: methylprednisolone; PDL: prednisolone; PDN: prednisone; MPS: mycophenolate sodium; MMF: mycophenolate mofetil; AZT: azathioprine; CYC: cyclosporine; RG: random glucose; FG: fasting glucose; Yr: year; Mo: month; Wk: week; NA: not available; DM: diabetes mellitus; Tx: therapy

Five of the now seven reported cases detail the development of diabetic ketoacidosis at least six months after renal transplantation (2-5, 7). In contrast, our case and the case detailed by Dr. Tuğcu and his colleagues describe the presentation of DKA and new onset diabetes within three months of transplantation (6).

Maintenance immunosuppressive therapy is essential to prevent organ rejection in renal transplant recipients. Calcineurin inhibitors play an integral role in most immunosuppressive regimens, with tacrolimus being the preferred agent over cyclosporine, as several studies show lower incidence of acute rejection with its use (1). Both calcineurin inhibitors are known to cause toxicity to pancreatic islet beta cells and may also directly affect transcriptional regulation of insulin expression (5). Evidence suggests that tacrolimus causes greater incidence of severe swelling-vacuolization, endoplasmic reticulum stress and apoptosis of pancreatic islet beta cells when compared to cyclosporine (8). Tacrolimus associated diabetogenic effects threaten the health and longevity of the allograft by predisposing the recipients to microvascular and macrovascular diabetic complications which subsequently reduce allograft survival.

The development of diabetes mellitus Type 1 with ketoacidosis in patients on therapeutic tacrolimus with no risk factors for diabetes highlights the need for alternative immunosuppressive agents which won’t compromise long-term survival of the patients’ allograft. This case report highlights the importance of regular fasting blood glucose monitoring in patients on a tacrolimus-regimen for immunosuppression in order to prevent the life-threatening complication of diabetic ketoacidosis and subsequent allograft rejection in the setting of uncontrolled diabetes mellitus.

Post-transplant diabetes mellitus is associated with increased mortality, by approximately 10 %, among renal transplant patients. The reduction in survival rate due to post-transplant diabetes mellitus is largely due to cardiovascular disease, such as coronary artery disease and congestive heart failure (9). Given the negative impact of NODAT in the survival of renal transplant patients, preventive efforts should be made to minimize risk factors. Known risk factors for NODAT include obesity, hepatitis C, African American race, Hispanic ethnicity, family history of diabetes mellitus, use of calcineurin inhibitor and/or corticosteroid. Early identification of patients at high risk for NODAT would help tailor immunotherapeutic suppressant regimen and to aggressively manage modifiable risk factors for NODAT (10, 11). The International Diabetes Federation (IDF) recommends proactive prescreening of all post-transplant patients for NODAT, with measurement of fast plasma glucose at least once per week for first 4 weeks post-transplant. Afterwards, post-transplant patients should have fasting plasma glucose test at 3, 6, 12 months, at 1-year intervals thereafter. Glycated hemoglobin (Hemoglobin A1C) is recommended to be check at 3 months following the transplant procedure (12).

Calcineurin inhibitors, including tacrolimus and cyclosporine, inhibit calcineurin in β-cells of the pancreas. Inhibition of calcineurin indirectly suppresses expression of genes involved in insulin production. In particular, adverse glycemic effect occurs with a greater incidence with tacrolimus than cyclosporine. This is thought to be mostly due to tacrolimus-induced changes in the level of β-cell enriched transcription factors, forkhead box protein O1 (FoxO1) and v-maf musculoaponeurotic fibrosarcoma oncogene homolog A (MafA). Tacrolimus selectively promotes nuclear translocation of FoxO1 and cytoplasmic location of MafA. These modulations of transcript factors then cause β-cell dysfunction, attributing to the development of NODAT (13).

Conclusion

Considering the potentially devastating complication of allograft compromise due to undiagnosed NODAT, it is imperative that clinicians monitor patients for signs of impaired glucose metabolism, specifically those who are treated with tacrolimus.

References

1. Heisel O, Heisel R, Balshaw R, Keown P. New onset diabetes mellitus in patients receiving calcineurin inhibitors: a systematic review and meta-analysis. Am J Transplant. 2004;4:583-95. [CrossRef] [PubMed]
2. Cho YM, Park KS, Jung HS, Kim YS, Kim SY, Lee HK. A case showing complete insulin independence after severe diabetic ketoacidosis associated with tacrolimus treatment. Diabetes Care. 2002;25:1664. [CrossRef] [PubMed]
3. Ersoy A, Ersoy C, Tekce H, Yavascaoglu I, Dilek K. Diabetic ketoacidosis following development of de novo diabetes in renal transplant recipient associated with tacrolimus. Transplant Proc. 2004;36:1407-10. [CrossRef] [PubMed]
4. Masood MQ, Rabbani M, Jafri W, Habib M, Saleem T. Diabetic ketoacidosis associated with tacrolimus in solid organ transplant recipients. J Pak Med Assoc. 2011;61:288-90. [PubMed]
5. Toyonaga T, Kondo T, Miyamura N, et al. Sudden onset of diabetes with ketoacidosis in a patient treated with FK506/tacrolimus. Diabetes Res Clin Pract. 2002;56:13-8. [CrossRef] [PubMed
6. Tuğcu M, Kasapoglu U, Boynuegri B, et al. Tacrolimus-Induced Diabetic Ketoacidosis and Effect of Switching to Everolimus: A Case Report. Transplant Proc. 2015;47:1528-30. [CrossRef] [PubMed]
7. Yoshida EM, Buczkowski AK, Sirrs SM, et al. Post-transplant diabetic ketoacidosis--a possible consequence of immunosuppression with calcineurin inhibiting agents: a case series. Transpl Int. 2000;13:69-72. [CrossRef] [PubMed]
8. Rangel EB. Tacrolimus in pancreas transplant: a focus on toxicity, diabetogenic effect and drug-drug interactions. Expert Opin Drug Metab Toxicol. 2014;10: 1585-605. [CrossRef] [PubMed]
9. Shivaswamy V, Boerner B, Larsen J. Post-transplant diabetes mellitus: causes, treatment, and impact on outcomes. Endocr Rev. 2016;37(1):37-61. [CrossRef] [PubMed]
10. Kasiske BL, Snyder JJ, Gilbertson D, Matus AJ. Diabetes mellitus after kidney transplantation in the United States. Am J Transplant. 2003;3:178-85. [CrossRef] [PubMed]
11. Karavelioglu D, Baysal C, Ozdemir N et al. Impact of HCV infection on the development of post transplantation diabetes mellitus in renal allograft recipients. Transplantation Proc. 2000;32;(3):561-2. [CrossRef] [PubMed]
12. Wilkinson A, Davidson J, Dotta F et al. Guidelines for the treatment and management of new onset of diabetes after transplantation. Clin Transplant. 2005;19:291-8. [CrossRef] [PubMed]
13. Trianes J, Rodriguez-Rodriguez AE, Brito-Cassilas Y, et al. Deciphering tacrolimus-induced toxicity in pancreatic β cells. Am J Transplant. 2017;17: 2829-40. [CrossRef] [PubMed] 

Cite as: Pak S, Hirschbeck M, Valencia D, Valencia V, Askaroglu Y, Nye D, Fershko A. Tacrolimus-associated diabetic ketoacidosis: a case report and literature review. Southwest J Pulm Crit Care. 2018;16(2):103-7. doi: https://doi.org/10.13175/swjpcc015-18 PDF