Who Will Benefit and Who Will Lose from Obamacare?

The debate continues over the Patient Protection and Affordable Care Act (ACA, Obamacare) (1). One the one hand the White House and their Democratic supporters say the law will: 1. Expand coverage to the poor; 2. Control costs; and 3. Improve care. On the other hand, opponents say the law is a job killer. Employers will be forced to eliminate positions, or reduce staffers to part-time hours to save costs. A recent article stated that Obamacare is certain to create a number of new positions but that seemed to be only part of the story (2). Below we offer our short lists of who will benefit and who will lose under Obamacare.

Who Will Benefit

1. Uninsured patients. Many patients who are uninsured or underinsured will benefit because their lack of health insurance results in delays in diagnosis and treatment. Uninsured patients often seek care in the hospital emergency department. Included in the uninsured are the poor and those with preexisting conditions.
2. Hospitals. Most hospitals are not-for-profit and as part of their community service provide free or undercompensated care to patients without health insurance. However, under Obamacare, hospitals will now receive payment improving profitability (3). However, the Center for Medicare and Medicaid Services (CMS) has shown a tendency to punish hospitals that underperform on certain performance measures such as 30 day readmission rate. It is possible that the initial increase in payments may be eventually be offset by reduction in payments for noncompliance.
3. Insurance Companies. Everyone will be required to purchase health insurance and that is great for the insurance business. Because there is some uncertainty regarding the eventual costs, insurance companies will generously estimate any increase in costs and pass this along to the consumer. Overall premiums will likely increase.
4. Lawyers. Obamacare rules and regulations are highly detailed, complex, confusing and changing. This will require increased numbers of lawyers to interpret the law and decide how it should be followed. It has been estimated that companies will spend $6 billion on legal services relating to government regulations this year, up 5% from 2012 (2). This will likely continue to increase under Obamacare.
5. Administrators and Bureaucrats.
   • The complicated rules and regulations of Obamacare will be policed at several levels. This will require increased manpower to maintain compliance from the hospital quality assurance department to the state and Federal government.
   • Payroll employees will need to increase. Obamacare requires employers to offer insurance to employees who work an average of 30 hours a week or more, at a cost for workers of not more than 9.5% of their annual salary. The responsibility of tracking work hours and health spending will fall to payroll departments.
   • Under Obamacare, doctors and hospitals must use electronic medical records, replacing paper systems with digital records and billing. According to the Bureau of Labor Statistics (BLS) the number of medical records and health information technicians employed in the U.S. has grown 7% to more than 182,000 since 2009, before Obamacare was enacted (4). Employers will also have to build new electronic systems to report the costs of their employees’ health coverage to the government, although they will have more time to do it, since the 2014 deadline has been extended.
   • Medical billing coders to submit the new electronic payments will be needed. The estimated 25-30 million new patients will bring many new bills. This will include coders not only for physician offices and hospitals, but also coding jobs for insurance companies. 
   • Navigating Obamacare will likely require a huge increase customer support staff known as “navigators”. The Centers for Medicare and Medicaid Services recently announced it would provide $54 million to fund the positions, and virtually any individual or entity could apply to serve as navigators.
   • Consultants will be needed to advise administrators how to reduce costs and increase profits. These consultants will cost money.
   • Administrators will likely seize the opportunity to increase their control over medical practice and increase their pay by claiming increased responsibilities supervising more employees. Over the past 20 years there has been a decrease in administrative efficiency and an accompanying increase in administrators and administrative costs (5). Obamacare will likely continue this trend.
6. Fitness Clubs & Health Education Providers. The law pressures employers to reduce their health spending by making workers healthier. Companies will likely hire health education providers to help employees design personalized nutrition and fitness programs, and offer workers incentives to participate. The field will grow 24% to over 300,000 positions by 2020, according to the BLS (6).
7. Nurse Practitioners and Physician Assistants. The increase numbers of people with health coverage through Obamacare is expected to increase the demand for physician services by at least 2% to 3% (2). Because Obamacare emphasizes preventive care, the increase will be especially high for primary care for services such as regular checkups and other preventive medicine. However, the relatively sudden increase in patients will not be matched by a sudden increase in physicians. Doctors, especially primary care physicians, are already in short supply and take years to educate before entering the workforce (1). The physician workforce cannot possibly be expected to expand sufficiently to handle the increase in patients. Rather, physician assistants and nurse practitioners will be needed to perform many of the same services. BLS forecasts PA jobs will grow 30% to more than 108,000 from 2010 to 2020 (7); registered nurses will increase 26% to more than 3 million (8).
8. Occupational therapists. Under Obamacare, patients with disabilities can no longer be denied health insurance. This will likely increase the demand for occupational therapists, which help optimize disabled people’s homes and workplaces to meet their mobility needs. However, like physicians, this profession is already in short supply with an unemployment rate of just 1% and a forecast for 43% growth in jobs by 2020 (9).

But what about the losers? Here’s our short list of losers under Obamacare.

Who Will Lose

1. Unemployed and small business. Small business owners' fear of the effect of the new health-care reform law on their bottom line is prompting many to hold off on hiring and even to shed jobs in some cases, a recent Gallup poll found (10). Forty-one percent of the businesses surveyed have frozen hiring because of Obamacare. Nineteen percent answered "yes" when asked if they had "reduced the number of employees you have in your business as a specific result of the Affordable Care Act” (10).
2. Physicians. Increased demand for physician services, which are already in short supply, should increase physician reimbursement. However, it has been clear for some time that the law of supply and demand does not apply to healthcare. Instead, Obamacare will further reduce fees to health care providers, by $415 billion over 2013-2022 (11). As these reductions go into effect, more and more physicians are certain to stop taking new patients whose insurance offers low reimbursement. This is already happening with Medicare and Medicaid patients. This may lead to poorer health outcomes especially in the poor, the very people Obamacare was intended to help the most (11).
3. The Poor in Some States. The poor should finally have access to affordable insurance under Obamacare, but millions will most likely remain uninsured (12). Low-income adults in the 21 states that aren't expanding Medicaid will not be eligible. Some 4.9 million people will not be covered in 2016 if these states don't expand, according to the Urban Institute. Another 1.5 million uninsured are in six states that are considering expansion, but have yet to approve it. The three states in the Southwest, Arizona, New Mexico and Colorado are all expanding.
4. Safety-Net Hospitals. Hospitals that serve the most vulnerable patients, so called safety-net hospitals, may be hurt by Obamacare (13). These hospitals receive “disproportionate share payments” through the Medicare and Medicaid programs, money to cover high levels of uninsured patients. These payments will be cut by more than $30 billion over the next decade. Under Obamacare, the safety-net hospitals will gain a new source of revenue when millions of the uninsured gain coverage but the law’s spending cuts could result in a net decrease in reimbursement. This may be especially true in those states that are not expanding Medicaid. Safety-net hospitals in these states may end up with the same number of uninsured patients but with less reimbursement.
5. Lightly-Regulated States. Some states allow insurers to sell bare-bones plans excluding the sick, which keeps costs down (14). Under Obamacare, insurers must offer a package of essential benefits -- including maternity, mental health and medications -- and must cover all who apply. States including Indiana, Ohio, Florida and South Carolina, have recently released preliminary rate information highlighting steep price increases. In contrast, states such as California and New York will likely see price reductions since they already require insurers to provide comprehensive coverage. Rates there could fall by half since the pool will expand to include many younger, healthier residents under Obamacare.
6. Young Men. Obamacare requires that women pay the same amount as men. Furthermore, Obamacare does not allow insurers to charge older participants more than three times the young. One analysis found that 21-year-old men will pay more, but older women and men will pay less (14). A young man's increase would be 63% while older men and women will pay about 6-7% less.
7. Healthy Patients. Healthy patients will likely pay more for less care. One example is healthy young men (see above), but also included are people who do not need many of the preventative services offered such as smoking cessation, weight reduction, etc.

Obamacare promises improved, cheaper healthcare. The logic is that costs would be reduced and healthcare would be improved by paying only for value- and evidence-based care. However, this approach has been in place for some time at CMS and has yet to reduce costs or improve care. For example, President Obama promised that electronic healthcare records would “…cut waste, eliminate red tape and reduce the need to repeat expensive medical tests”. However, rather than reduce costs, the opposite happened. With better documentation, physicians billed at higher levels actually increasing costs (15). Response blaming physicians was swift implying physician malfeasance rather than administrative mismanagement (16). To date no evidence of widespread fraud has been produced. Even CMS’ highly touted hospital infection reduction program fails to pass muster on close inspection. The incidence of hospital infection relies on hospitals self-reported data. Faced with a financial penalty, many hospitals have chosen to be less than truthful about their infection rates rather than accept a reduction in payments (17).

Most of the deficiencies of Obamacare can be corrected. Correction can only occur when programs are tested and then observationally evaluated to identify problems that may arise. Elements of programs that are beneficial should be continued and improved. Bad ones should be dropped. The political game of continuing costly programs that do not improve healthcare and spinning the results will jeopardize everyone’s future. Even with the most perfect programs (and Obamacare is far from that), Obamacare insures 30 million additional people and that costs more. The money to pay for it will have to come from healthy workers. There is no such thing as a free lunch.

Richard A. Robbins, MD*

Manoj Mathew, MD*

References

1. Kaiser Family Foundation. Summary of the affordable healthcare act. Available at: http://kff.org/health-reform/fact-sheet/summary-of-new-health-reform-law/ (accessed 8/12/13).
2. Wieczner J. 10 Careers Boosted by Obamacare. Available at: http://finance.yahoo.com/news/10-careers-boosted-obamacare-150410654.html?page=2. (accessed 8/12/13). 
3. Patton W. Obamacare, part III: who will benefit the most? Forbes. Available at: http://www.forbes.com/sites/mikepatton/2012/11/30/obamacare-part-iii-who-will-benefit-the-most/ (accessed 8/12/13).
4. Bureau of Labor Statistics. Occupational outlook handbook: medical records and health information technicians. Available at: http://www.bls.gov/ooh/Healthcare/Medical-records-and-health-information-technicians.htm (accessed 8/12/13).
5. Woolhandler S, Campbell T, Himmelstein DU. Health care administration in the United States and Canada: micromanagement, macro costs. Int J Health Serv. 2004;34(1):65-78. [CrossRef] [PubMed]
6. Bureau of Labor Statistics. Occupational outlook handbook: fitness trainers and instructors. Available at: http://www.bls.gov/ooh/personal-care-and-service/fitness-trainers-and-instructors.htm (accessed 8/12/13).
7. Bureau of Labor Statistics. Occupational outlook handbook: physician assistants. Available at: http://www.bls.gov/ooh/Healthcare/Physician-assistants.htm (accessed 8/12/13).
8. Bureau of Labor Statistics. Occupational employment statistics: occupational employment and wages, May 2012, 29-1171 nurse practitioners. Available at: http://www.bls.gov/oes/current/oes291171.htm (accessed 8/12/13).
9. Bureau of Labor Statistics. Occupational outlook handbook: occupational therapists. Available at: http://www.bls.gov/ooh/healthcare/occupational-therapists.htm (accessed 8/12/13).
10. Mangan D. Will Obamacare hurt jobs? it's already happening, poll finds. CNBC. Available at: http://www.cnbc.com/id/100825782 (accessed 8/12/13).
11. Robbins RA. What to expect from Obamacare. Southwest J Pulm Crit Care. 2013;6(1):23-8.
12. Luhby T. Who loses out under Obamacare? CNNMoney. Available at: http://money.cnn.com/2013/07/25/news/economy/obamacare-medicaid/index.html (accessed 8/12/13).
13. Kliff S. Hospitals serving the uninsured face challenge under Obamacare. Washington Post. Available at: http://www.washingtonpost.com/blogs/wonkblog/wp/2013/04/16/hospitals-serving-the-uninsured-face-challenge-under-obamacare/ (accessed 8/12/13).
14. Luhby T. Where Obamacare premiums will soar. CNNMoney. Available at: http://money.cnn.com/2013/08/06/news/economy/obamacare-premiums/index.html?iid=obinsite (accessed 8/12/13).
15. Haig S. Electronic medical records: will they really cut costs? Time 2009. Available at: http://www.time.com/time/health/article/0,8599,1883002,00.html#ixzz2FF0XBf5d (accessed 8/12/13).
16. Carlson J. HHS inspector general's office quizzes providers about EHR use. Modern Healthcare 2012. Available at: http://www.modernhealthcare.com/article/20121023/NEWS/310239946  (accessed 8/12/13).
17. Meddings JA, Reichert H, Rogers MA, Saint S, Stephansky J, McMahon LF. Effect of nonpayment for hospital-acquired, catheter-associated urinary tract infection: a statewide analysis. Ann Intern Med 2012;157:305-12. [CrossRef] [PubMed]

*The views expressed are those of the authors and do not necessarily represent those of the Arizona, New Mexico or Colorado Thoracic Societies or the Mayo Clinic.

Reference as: Robbins RA, Mathew M. Who will benefit and who will lose from Obamacare? Southwest J Pulm Crit Care. 2013;7(2):103-8. doi: http://dx.doi.org/10.13175/swjpcc106-13 PDF

Smoking, Epidemiology and E-Cigarettes

"The true face of smoking is disease, death and horror - not the glamour and sophistication the pushers in the tobacco industry try to portray." - David Byrne

In our fellows’ conference we recently reviewed the evolution of the science of clinical epidemiology as it relates to the association of smoking and lung cancer and the concurrent history of tobacco marketing in the United States. 

This story begins in 1950, when Richard Doll and Austin Bradford Hill published their landmark case control study demonstrating the association between smoking and lung cancer (1). This study was performed with methodological standards that have rarely been matched in the 63 years since.  Exhaustive analysis of possible confounders, a multi-stage evaluation of study blinding, determination of dose-effect, and the use of multiple analyses to establish consistency are among many examples of superb attention to detail exercised by Doll and Hill in this study.  The results showed that patients with lung cancer were about 15 times more likely than matched control patients to have smoked tobacco (Odds ratio 15).  The p-value was 0.00000064  - indicating that the probability of calculating such a result by chance alone is less than one-in-a-million.  In comparison, many modern case control trials are characterized by weak associations (odds ratios of 1-3) with p-values that are barely significant.  Yet the phenomenal and nearly unparalleled results of this study had practically no discernable effect on the increasing rate of smoking in the following decade.

Many factors opposed the conclusions of Doll and Hill.  Atmospheric pollution – perhaps emanating from motor car exhaust or asphalt tarmac – was felt to be the leading suspect in the increasing incidence of lung cancer.  At the time, it seemed inconceivable to most people that smoking could cause cancer.  Two thirds of British men smoked.  Smoking was widely endorsed by the medical profession – Doll and Hill themselves had both previously been smokers.  The British Department of Health did not endorse their findings, amid worries that the study might start a panic.  Several prominent statisticians, including Sir Ronald Fisher, publicly criticized their study design and conclusions.  Fisher was a polymath – a genius with significant accomplishments in multiple disciplines, widely recognized as the founder of modern statistics, having invented Fisher’s exact test, and ANOVA and having collaborated in the development of the Student’s T test.  Fisher was also an avid smoker.  It was later disclosed that Fisher had lucrative financial ties to the tobacco industry, raising questions whether Fisher’s criticisms of Doll and Hill were bought and paid for.

Doll and Hill followed up with a stronger study design – performing one of the finest cohort studies ever – the British Physician’s study.  They enrolled over 40,000 British Physicians – almost 70% of all registered in Britain.  Outcomes in this cohort were eventually evaluated over 50 years, and contributed to our knowledge in many areas of medicine.  But the results in regards to the relationship between smoking and lung cancer were objectively convincing within the first decade of follow-up.  In an interim analysis in 1961 (2), the relative risk for lung cancer in smokers was found to be increased 18 times – consistent with the findings of their case control trial.  Fisher’s exact test was incalculable in 1961 since it required the quantization of enormous factorials, but I calculated a p-value of 0.0000000000000001 (one in 100-quadrillion) using their data and an on-line Microsoft statistics program.  It’s satisfying to find that Fisher’s namesake statistic so convincingly validates the conclusions that he personally refuted.  Sir Austin Bradford Hill is famous for his contention that we often over-focus on achieving a p-value < 0.05 in modern medical research – the incomparable statistical significance of this study illustrates his point.  

Despite increasing scientific evidence against smoking, cigarette consumption in the U.S. continued to rise, and did not fall below pre-1950 levels until the early eighties.  A further generation of young men took on the habit, many of which were introduced to smoking in the armed services - cigarettes having been routinely included in C-rations of US soldiers who fought in WWII, Korea and Viet Nam.  Cigarette smoking was endorsed by everyone from movie stars, to sports stars to doctors – Bob Hope, Mickey Mantle and Ronald Reagan among them.  Santa Claus appeared in multiple ads with a cigarette in one hand, and his red toy bag in the other – fecklessly endorsing multiple different brands including Lucky Strikes and Pall Malls. 

Several tobacco advertisement campaigns were particularly influential.  Philip Morris introduced the “Marlboro Man”, considered one of the most brilliant ad campaigns in history, in 1954.  Marlboro cigarettes were filtered.  The implied (but factitious) protective benefits of the filter were not explicitly marketed, but filtered cigarettes were considered “feminine” at the time.  The use of real rodeo cowboys in the Marlboro ads dramatically changed that impression – particularly in the minds of post adolescent boys.  One indication of the success of the Marlboro Man is that Philip Morris is said to have spent $300 million dollars finding a replacement when Darrell Winfield, the most famous of the Marlboro men, retired.

In the late sixties, Philip Morris also marketed smoking to young women with a brand designed specifically for women called Virginia Slims.  Riding the wave of women’s liberation, the slogan “You’ve come a long way baby” promoted smoking as a way to express emancipation and empowerment.   RJ Reynolds introduced the “Joe Camel” ad campaign in 1987, allegedly targeting children with a cool-looking cartoon of an anthropomorphic camel.  Sounds silly, I know, but it worked.  In 5 short years after starting this campaign, the annual sales of Camel cigarettes to teenagers rose from 6 million to 470 million dollars.  At its peak, it was shown that six-year-old children could associate the character of “Joe Camel” with Camel cigarettes about as frequently as they could associate Mickey Mouse with Disney.  A study published in JAMA concluded that tobacco experimentation by 700,000 adolescents per year could be attributed to targeted advertising (3). 

Although public education had already made great inroads in reducing smoking in the US by the 80’s, legal and governmental anti-smoking pressure began to build thereafter.  In 1988, Rose Cipollone  posthumously won the first successful wrongful harm lawsuit of a smoker against a tobacco manufacturer.  Mangini sued RJ Reynolds on behalf of children in regards to the Joe Camel ad campaign.  In the 1988 Report of the Surgeon General, C Everett Koop concluded that nicotine has an addictiveness similar to that of heroin.  C Everett Koop’s continuing efforts to raise public awareness initiated some of the first public discourse in regards to the dangers of second-hand smoke (subsequently found to cause 50,000 deaths per year in the U.S.).  Smoking rates in the United States declined from 38% to 27% during his tenure.

In the 1990s, the tobacco lobby engaged in a comprehensive and aggressive political effort to neutralize clean indoor air legislation, minimize tobacco tax increases, and preserve the industry's marketing strategies.  However the famous Waxman congressional hearings intervened in 1997.  In sworn testimony before congress, the CEOs of seven major tobacco companies famously asserted that smoking tobacco was not addictive, contrary to incontrovertible scientific evidence.  Two sources revealed their insincerity.  The first was testimony of previous employees of the tobacco industry, such as Jeffrey Wigman and Victor DeNoble, who testified that the addictive and carcinogenic properties of cigarette tobacco had been artificially manipulated by the industry.   The second was the discovery of internal tobacco industry memos, which revealed that the addictive properties of tobacco were well recognized within the industry as early as 1960s.  A few excerpts follow:

“… nicotine is addictive. We are, then, in the business of selling nicotine, an addictive drug” July 17, 1963 report by then Brown & Williamson general counsel/vice president Addison Yeaman.

 “The cigarette should be conceived not as a product but as a package. The product is nicotine. …Think of a cigarette as a dispenser for a dose unit of nicotine…”  1972 William Dunn, Jr., of the Philip Morris Research Center, “Motives and Incentives in Cigarette Smoking.”

“Within 10 seconds of starting to smoke, nicotine is available in the brain. . . giving an instantaneous catch or hit . . . Other “drugs” such as marijuana, amphetamines, and alcohol are slower”  Circa 1980  C.C. Greig in a BAT R&D memo

The Waxman hearings resulted in a $368 billion dollar assessment against the tobacco industry, and increased restrictions on advertising and lobbying.  Shortly thereafter, the Joe Camel and Marlboro Man ad campaigns were terminated.  With the public revelation that three previous Marlboro Men had died from lung cancer, that ad campaign had lost its appeal.  

In the late 90s/early 2000s, the nicotine content of all major brands of cigarettes was progressively increased on average by 1.8% per year.  This might theoretically make it harder for smokers to kick the habit.  Sales promotions totaling about $400 per year per smoker were directed at loyal smokers.  Despite restrictions, the tobacco industry continued to invest $25 million dollars per year in lobbying.  Upon further negotiation, the tobacco master settlement was reduced to 200 billion – only 12.7 billion to be paid up front.  The full details of this settlement have become increasingly legally obfuscated over time in my opinion; some states are actually selling tobacco settlement bonds now to protect themselves against loss of future return from the settlement.   

Although US cigarette consumption has dramatically fallen, worldwide sales are peaking, and the international rates of women smokers are still on the rise.  Philips Morris restructured and rebranded their corporation as Altria (sounds like the word “altruistic”).  They subsumed Kraft and Nabisco foods, but the majority of their >100,000 million dollars in annual revenue are derived from tobacco sales, about two-thirds of which are international. 

Many US tobacco firms are rapidly investing in production and marketing of electronic cigarettes that vaporize nicotine for inhalation.  It is likely that inhaling vaporized nicotine is less dangerous than smoking tobacco.  However, the health effects of inhaling vaporized nicotine are not well studied yet.  The purported benefits of vaping over smoking have already been publicly aired as an argument to turn back current restrictions on public smoking.  Electronic cigarettes are being advertised as glamorous again in advertisements reminiscent of tobacco ads seen in the 1970s.  E-cigs in which nicotine is flavored with chocolate, or various fruit flavors, seem to once-again target children.  The promotion of a highly addictive drug to children and young adults cannot be beneficial to society in the long term, even if vaping doesn’t lead to lung cancer.  But the rapid increase in vaping promises that another round in the societal struggle against nicotine addiction is about to begin again.

Doll and Hill’s work played a tremendous beneficial role in this story.  Their case control and cohort studies set the methodological standard by which all subsequent observational trials should be measured – although our experience in journal club is that modern observational trials don’t even come close.  Furthermore, their work became the basis for the subsequent formulation of the “Bradford Hill Criteria” for establishing causation, which still plays a dominant role in medical and medicolegal reasoning.   

Robert A. Raschke, MD

Associate Editor 

References

1. Doll R, Hill AB. Smoking and carcinoma of the lung; preliminary report. Br Med J. 1950;2(4682):739-48. [CrossRef]
2. Doll R, Hill AB. The mortality of doctors in relation to their smoking habits; a preliminary report. Br Med J. 1954;1(4877):1451-5. [CrossRef]
3. Pierce JP, Choi WS, Gilpin EA, Farkas AJ, Berry CC. Tobacco industry promotion of cigarettes and adolescent smoking. JAMA. 1998;279(7):511-5. [CrossRef] [PubMed]   

Reference as: Raschke RA. Smoking, epidemiology and e-cigarettes. Southwest J Pulm Crit Care. 2013;7(1):41-5. doi: http://dx.doi.org/10.13175/swjpcc092-13 PDF

Treatment after a COPD Exacerbation

A couple of years ago I was consulted about a patient at the Phoenix VA who had been admitted for the third time for a COPD exacerbation in two months. Each time the patient was treated with inhaled short-acting bronchodilators, corticosteroids and an antibiotic; rapidly improved; and was discharged after only one or two days in the hospital.  The discharge medications were albuterol, ipratropium, and rapidly tapering doses of prednisone. Apparently, no consideration was given to adding long-acting beta agonists (LABA), long-acting muscarinic antagonists (LAMA), and/or inhaled corticosteroids (ICS). These later medications have been shown to reduce exacerbations in most studies (1,2).

I was reminded of this incident by a recent article published by Melzer et al. in the Journal of Internal Medicine (3). The authors examined 2760 patients with exacerbations of COPD admitted to hospitals in the VA Northwest Health Network (VISN 20) to determine if a LABA and/or glucocorticoid were prescribed at discharge. These medications reduce exacerbations and the best predictor of a future exacerbation is a history of exacerbations (1,2,4). Of the 2760 patients 93% were not receiving a LABA or an ICS at the time of their exacerbation. Of this 93%, two-thirds of the patients had no change in therapy after their exacerbation. The authors state that “among patients treated for COPD exacerbations, there were missed opportunities to potentially reduce subsequent exacerbations by adding treatments known to modify exacerbation risk”. The authors go on to suggest that the VA could develop a Quality Enhancement Research Initiative (QUERI) program to improve delivery of care for some chronic conditions.

So why did the patient at the Phoenix VA and 2/3 of the patients in VISN 20 not receive a LABA, LAMA and/or inhaled corticosteroid after their exacerbations as recommended by the GOLD and ATS guidelines? Are the doctors in the Pacific Northwest and Phoenix unaware of the guidelines as the article and its accompanying editorial imply (5)? The answer probably lies elsewhere. First, the VA does not use the GOLD or ATS guidelines but has developed their own guidelines (6). These guidelines specifically mention consideration of the addition of inhaled corticosteroids and a LAMA but make no mention of a LABA. Rather than encouraging use of these medications, programs were created at the Phoenix VA which restricted Veterans’ access to these more expensive medications. The VA administration empowered the pharmacy to make unilateral decisions based on fiscal considerations with inadequate expert clinician input. These include a requirement to refer all patients for pulmonary consultation for long-acting bronchodilator therapy. This overloaded the pulmonary clinics with patients that did not necessarily need to be seen. In addition, there was a requirement for a trial of ipratropium before beginning tiotropium which took multiple visits further overloading the clinics.

This is another example of administrators meddling in clinical care only to have it blow up in their face and cause something else to go awry wasting money. In this case, the low use of long-acting bronchodilators likely led to an increase in admissions for exacerbation of COPD which are a major determinant of the costs of COPD care (7). Ignorance of the providers is blamed and another program to correct the harm caused by the initial blunder is created. Another example is the control of blood sugar in the ICU. After pushing for tight control of blood sugar for several years, the VA Inpatient Evaluation Center (IPEC) seamlessly converted their program to one examining hypoglycemia when tight control resulting in hypoglycemia was found to be harmful with the publication of the NICE-SUGAR study (8,9).

A QUERI program examining whether a LABA and/or corticosteroid was prescribed at discharge for a COPD patient does not need to be created. What needs to be done is to allow the physicians in the Pacific Northwest and Phoenix to use their best skills and judgment in caring for the patients without interference. If something must be measured, readmissions for exacerbation of COPD could be considered but should be part of a comprehensive program that measures outcomes such as mortality, length of stay, and morbidity. Otherwise, administrative blunders to correct past mistakes will continue.

Richard A. Robbins, M.D.*

References

1. Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2010. Available at: http://www.goldcopd.org/Guidelines/guidelines-resources.html  (accessed 7/7/13)
2. Qaseem A, Wilt TJ, Weinberger SE, Hanania NA, Criner G, van der Molen T, Marciniuk DD, Denberg T, Schünemann H, Wedzicha W, MacDonald R, Shekelle P; American College of Physicians; American College of Chest Physicians; American Thoracic Society; European Respiratory Society. Diagnosis and management of stable chronic obstructive pulmonary disease: a clinical practice guideline update from the American College of Physicians, American College of Chest Physicians, American Thoracic Society, and European Respiratory Society. Ann Intern Med. 2011;155(3):179-91. [CrossRef] [PubMed]
3. Melzer AC, Feemster LM, Uman JE, Ramenofsky DH, Au DH. Missing potential opportunities to reduce repeat COPD exacerbations. J Gen Intern Med. 2013;28(5):652-9. [CrossRef] [PubMed]
4. Hurst JR, Vestbo J, Anzueto A, Locantore N, Müllerova H, Tal-Singer R, Miller B, Lomas DA, Agusti A, Macnee W, Calverley P, Rennard S, Wouters EF, Wedzicha JA; Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) Investigators. Susceptibility to exacerbation in chronic obstructive pulmonary disease. N Engl J Med 2010;363:1128-38. [CrossRef] [PubMed]
5. Jubelt LE. Capsule Commentary on Melzer et.al., Missing Potential Opportunities to Reduce Repeat COPD Exacerbations. J Gen Intern Med. 2013;28(5):708. [CrossRef] [PubMed]
6. The Management of COPD Working Group. VA/DOD clinical practice guideline for management of outpatient chronic obstructive pulmonary disease. Available at: http://www.healthquality.va.gov/copd/copd_20.pdf (accessed 7/7/13)
7. Hilleman DE, Dewan N, Malesker M, Friedman M. Pharmacoeconomic evaluation of COPD. Chest. 2000;118(5):1278-85. [PubMed] [PubMed]
8. Falciglia M, Freyberg RW, Almenoff PL, D'Alessio DA, Render ML. Hyperglycemia-related mortality in critically ill patients varies with admission diagnosis. Crit Care Med. 2009;37(12):3001-9. [CrossRef] [PubMed]
9. 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;360(13):1283-97. [CrossRef] [PubMed]

*The opinions expressed are those of the author and not necessarily the Southwest Journal of Pulmonary and Critical Care or the Arizona, New Mexico or Colorado Thoracic Societies.  

Reference as: Robbins RA. Treatment after a COPD exacerbation. Southwest J Pulm Crit Care. 2013;7(1):28-30. doi: http://dx.doi.org/10.13175/swjpcc089-13 PDF

Executive Pay and the High Cost of Healthcare

Two recent articles examined hospital executive pay. One was “Bitter Pill: Why Medical Bills Are Killing Us” from Time magazine (1). We reviewed this article in our “March 2013 Critical Care Journal Club” (2). The other is a more recent article from Kaiser Health News (3). The later is particularly intriguing since it discusses healthcare executive compensation. We thought it might be of interest to examine executive compensation from selected nonprofit hospital tax returns from Arizona, New Mexico and Arizona. (Table 1). [Editor's note: It may be necessary to enlarge the view on your browswer to adquately visualize the tables.]

Table 1. Financial information from Southwest hospitals latest year tax return as listed by GuideStar (4).

*Includes Scottsdale Healthcare Corporation

These Southwest hospitals appear to be doing quite well. Overall they had combined incomes of $19,831,088,546, assets of $ 10,228,640,923 and profits of $1,145,888,944. None lost money. Although the data from organizations such as Dignity, Banner, Scottsdale Healthcare, Exempla, and Presbyterian Healthcare include several hospitals, they are doing well, especially for “nonprofit” hospitals.

The CEOs were also doing well (Table 2).

Table 2. CEO and executive compensation from Southwest hospitals latest year tax return as listed by GuideStar (4).

*Includes employees listed on Form 990.

**Includes Scottsdale Healthcare Corporation

The CEOs were paid an average of $1,718,484 and the average executive made $591,618. Not bad for being paid by a “nonprofit” organization. The CEO pay is nearly 8 times and the executive pay is nearly 3 times the slightly over $200,000 average Southwest pulmonary and critical care physician received in 2011 (5).

The Kaiser Healthcare News article went on to point out that boards at nonprofit hospitals are often paying hospital administrators much more for boosting volume than delivering healthcare value (3). Hospital administrators agreed but were quick to point out that compensation is increasingly being determined by healthcare performance incentives. However, James Guthrie, a hospital compensation consultant for Integrated Healthcare Strategies stated about administrative compensation, "What you're seeing is incentive plans that look pretty similar to what they looked like five years ago or ten years ago…they're changing, but they're changing fairly slowly."

Two of the local executives mentioned in the Kaiser Healthcare News article were Lloyd Dean and Peter Fine, heads of Dignity Health and Banner Health respectively. Incentive goals for Dean included unspecified "annual and long-term financial performance” (4). Dean's bonus for 2011 was $2.1 million. Fine speaks of "an unwavering commitment to improve clinical quality and efficiency" but Fine's long-term incentive goals included profits and revenue growth (4).

"Boards of trustees in health care are oriented around top-line, revenue goals," said Dr. Donald Berwick, who was CEO of the Institute of Healthcare Improvement (IHI) and later the Administrator for the Centers for Medicare and Medicaid Services (CMS) (Figure 1).

Figure 1. Dr. Donald Berwick

"They celebrate the CEO when the hospital is full instead of rewarding business models that improve patients' care." Such deals undermine measures in the 2010 health law that aim to cut unnecessary treatment and control costs, say economists and policy authorities (3).

An explosion of medical regulatory groups have arisen to improve quality, including Berwick’s IHI. These regulatory groups have often produced guidelines embraced by hospital administrators as improving healthcare. However, the administrators are often self-servingly paid bonuses for guideline compliance. Because nearly all the regulatory organizations are “nonprofit” like the hospitals, surely they would have more modest profits (Table 3).

Table 3. Financial information of healthcare regulatory organizations from latest year tax return as listed by GuideStar (4).

We are happy to report that the regulatory organizations had much more humble finances compared to the Southwest hospitals. Overall the four we examined totaled incomes of $589,724,293, assets of $563,032,211 and profits of $30,489,739. Only the American Board of Internal Medicine lost money with a loss of $-1,733,146 on income of nearly $50 million. For comparison, we added the Phoenix Pulmonary and Critical Care Research and Education Foundation to Table 3. It is the financial source behind the Southwest Journal of Pulmonary and Critical Care.

Executive pay was also more modest than Southwest hospital administrators (Table 4).

Table 4. CEO and executive compensation from healthcare regulatory organizations latest year tax return as listed by GuideStar (4).

*Includes employees listed on Form 990.

The CEOs were paid an average of $885,938 and the average executive made $382,009. Although much lower than the average $1,718,484 and the $591,618 paid to Southwest hospital CEO and executives, these salaries are still not bad for a “nonprofit” organization.

The only regulatory organization to lose money was the American Board of Internal Medicine. Either an increase or revenue or a decrease in expenses will eventually be necessary. The major source of income for the American Board is test revenue and increasing the fee for certification or the frequency and/or fees for maintenance of certification may be necessary. Alternatively, they could pay their CEO less than $786,751, eliminate the CEO’s spousal travel benefits, or lower the compensation for general internists such as Eric Holmboe from $417,945 to be more in line with the $161,000 average income of general internists in the mid-Atlantic region (4,5).

Donald Berwick has a good point and is correct. Hospital administrators need to be rewarded more for improving healthcare and less for keeping the hospital full and profits high. However, in 2009 while CEO at IHI Berwick was compensated $920,952 (4). This is almost 7 times the compensation of the average pediatrician in New England (5). Included were $88,200 in bonuses. It is unclear from the tax return what justified these bonuses (4).

Executive pay for both hospital and regulatory administrators is too high and contributes to the high cost of healthcare. We find no evidence that either type of administrator contributes much to improved patient-centered outcomes. Quality care continues to rely on an adequate number of good doctors, nurses and other healthcare providers. If anyone should be paid bonuses for healthcare, it is those providing care, not administrators.

Present bonus systems for healthcare administrators are perverse. As noted above these include bonuses for keeping the hospital full and profits high, neither consistent with what should be the goals of a nonprofit organization. Furthermore, increasing pay for supervising an increased number of administrative personnel will only add to the increasing costs. If administrators must be paid a bonus let them be paid for performance directly under their control. This could include ensuring that adequate numbers of good doctors and nurses are caring for the patients and improving administrative efficiency. These should result in better care but lower numbers of administrators consuming fewer healthcare dollars.

Last Friday, June 14, the Medicare Payment Advisory Commission, or MedPAC released their recommendations to Congress (8). These include recommendations that may be relative to hospital administrative pay. One is for “site-neutral payment”. Currently Medicare pays hospitals more than private physician offices for many services. MedPAC recommended that Congress “move immediately to cut payments to hospitals for many services that can be provided at much lower cost in doctors’ offices.” The commission said that “current payment disparities had created incentives for hospitals to buy physician practices, driving up costs...” This will increase the hospital’s bottom line, and therefore, the administrators’ bonuses. We agree with MedPAC’s recommendation.

MedPAC also told Congress that “the financial penalties that Medicare imposes on hospitals with high rates of patient readmissions are too harsh for hospitals serving the poor and should be changed.” Based on this and data that higher mortality is associated with lower readmission rates, we agree (9). Rewarding hospitals for potentially harmful patient practices that increase the hospital’s bottom line are not appropriate. Financial incentives for reducing readmissions should only be part of a more global assessment of patient outcomes including mortality, length of stay and morbidity. Regulatory administrators need to become more focused on patients and less on an endless array of surrogate markers that have little to do with quality of care.

Richard A. Robbins, M.D.*

Clement U. Singarajah, M.D.*

References

1. Brill S. Bitter Pill: Why Medical Bills Are Killing Us. Time. February 20, 2013. PDF available at: http://livingwithmcl.com/BitterPill.pdf (accessed 6/17/13).
2. Stander P. March 2013 critical care journal club. Southwest J Pulm Crit Care. 2013;6(4):168-9. Available at: /critical-care-journal-club/2013/4/2/march-2013-critical-care-journal-club.html (accessed 6-17-13).
3. Hancock J. Hospital CEO Bonuses Reward Volume And Growth. Kaiser Health News. June 16, 2013. Available at: http://www.kaiserhealthnews.org/Stories/2013/June/06/hospital-ceo-compensation-mainbar.aspx (accessed 6-17-13).
4. http://www.guidestar.org/ (accessed 6-17-13).
5. http://www.medscape.com/sites/public/physician-comp/2012 (accessed 6-17-13).
6. Robbins RA, Thomas AR, Raschke RA. Guidelines, recommendations and improvement in healthcare. Southwest J Pulm Crit Care 2011;2:34-37. Available at: /editorial/2011/2/25/guidelines-recommendations-and-improvement-in-healthcare.html
7. Robbins RA. Why is it so difficult to get rid of bad guidelines? Southwest J Pulm Crit Care 2011;3:141-3. Available at: /editorial/2011/11/1/why-is-it-so-difficult-to-get-rid-of-bad-guidelines.html
8. http://www.medpac.gov/documents/Jun13_EntireReport.pdf (accessed 6-17-13).
9. Robbins RA, Gerkin RD. Comparisons between Medicare mortality, morbidity, readmission and complications. Southwest J Pulm Crit Care. 2013;6(6):278-86. Available at: /general-medicine/2013/6/13/comparisons-between-medicare-mortality-readmission-and-compl.html

*The opinions expressed are those of the authors and not necessarily the Southwest Journal of Pulmonary and Critical Care or the Arizona, New Mexico or Colorado Thoracic Societies.

Reference as: Robbins RA, Singarajah CU. Executive pay and the high cost of healthcare. Southwest J Pulm Crit Care. 2013;6(6):299-304. doi: http://dx.doi.org/10.13175/swjpcc080-13 PDF

Choosing Wisely-Where Is the Choice?

A little over a year ago an editorial was posted in the Southwest Journal about the Choosing Wisely campaign from the American Board of Internal Medicine and Consumer Reports (1). You may remember that Choosing Wisely announced a list of procedures or treatments that patients should question (2). In the editorial we wondered why pulmonary organizations such as the American Thoracic Society (ATS) and the American College of Chest Physicians authored none of the recommendations and offered 10 suggestions. We also openly questioned if the recommendations were intended to improve patient care or reduce costs, and thus improve the profits of third party carriers.

We can now report that recommendations were announced at the recent ATS meeting in Philadelphia. Seven recommendations were made for critical care and seven for pulmonary disease. Five from the critical care list and five from the pulmonary list will eventually be chosen for inclusion in Choosing Wisely. The recommendations are listed below:

Critical Care

1. Thou shalt not order diagnostic tests at regular intervals (e.g., daily) but instead order tests based on needs.
2. Thou shalt not use parenteral nutrition in the first 7 days of an ICU admission in patients adequately nourished.
3. Thou shalt not transfuse red blood cells in hemodynamically stable patients with a hemoglobin > 7 gm/dL.
4. Thou shalt not sedate mechanically ventilated patients without an indication.
5. Thou shalt not continue life support for at patients at high risk for death.
6. Thou shalt not initiate or continue antimicrobials without an indication.
7. Thou shalt not place or maintain an arterial or central venous catheter without an indication.

Pulmonary

1. Thou shall not perform thoracic CT scans for follow up of pulmonary nodules more frequently than the guidelines (Fleishner Society) suggest.
2. Thou shalt not discontinue oxygen from recently discharged patient prescribed oxygen without checking for hypoxemia.
3. Thou shalt not routinely administer intravenous corticosteroids for exacerbations of asthma or chronic obstructive pulmonary disease when the patient is able to take oral steroids.
4. Thou shalt not do thoracic CT scan screening for patients at low risk for lung cancer.
5. Thou shalt not do chest x-rays on asymptomatic patients routinely.
6. Thou shalt not offer vasoactive agents for groups 2 (left heart disease) and 3 (hypoxia) pulmonary artery hypertension (PAH).
7. Thou shalt not perform thoracic CT angiography for pulmonary embolism on patients with low probability and a negative d-dimer.

In the question and answer session after the recommendations were presented, a member of the audience noted that most of the recommendations were negative, directing physicians what not to do. We confess that we added the “Thou shalt not …” to emphasize this point but cannot overlook the fact that these recommendations look suspiciously like commandments. The negativity implicit in the ATS recommendations is consistent with the recommendations by other subspecialties listed on the Choosing Wisely website (2).  While the recommendations are reputedly about reducing the use of unnecessary or potentially dangerous testing, both worthy goals, the tone suggests there will be consequences for failure to comply.

What we find offensive is the Choosing Wisely and ultimately the ABIM foundation assertion that this is an initiative “focused on encouraging physicians, patients and other health care stakeholders to think and talk about medical tests and procedures that may be unnecessary” (2). Where is the encouragement and where is the choice in a series of DO NOT commandments?  It seems an even-handed approach of an objective statement would be much more appropriate and yet carry the same information, e.g. Chest CT scans are rarely required for screening patients at low risk for lung cancer rather than “Do not do thoracic CT scan screening for patients at low risk for lung cancer”.  It seems that rather than encouraging conversation the Choosing Wisely statement puts doctor and patient in an adversarial relationship especially if the doctor feels something is needed which is expressly stated with a “Do not”.

Rather than a laundry list of no-no’s a guiding principle might be better. The American College of Physicians (ACP) has offered, “The physician should always act in the best interests of the patient” (3). Despite objections to the profession of the author of the ACP statement, a lawyer, the overall sentiment is a good one (4). It removes the adversarial relationship the Choosing Wisely campaign encourages and places physicians where they belong-on the side of the patient.

In our view the present Choosing Wisely campaign has fundamental flaws-not because it is medically wrong but because it attempts to replace choice and good judgment with a rigid set of rules that undoubtedly will have many exceptions. Based on what we have seen so far, we suspect that Choosing Wisely is much more about saving money than improving patient care. We also predict it will be used by the unknowing or unscrupulous to further interfere with the doctor-patient relationship.  When the recommendations of an authoritarian body take the form of commandments and preempt clinical decision making, then it seems the wise choice of a wary clinician is to tacitly comply - in other words there is no choice.

Richard A. Robbins, M.D.*

Allen R. Thomas, M.D.*

References

1. Robbins RA, Thomas AR. Will fewer tests improve healthcare or profits? Southwest J Pulm Crit Care 2012;4:111-3.
2. http://www.choosingwisely.org/ (accessed 6/3/13).
3. Snyder L.  American College of Physicians Ethics Manual.  Sixth Edition.  Ann Intern Med. 2012:156;1:suppl 73-101.
4. Raschke RA. February 2012 critical care journal club. Southwest J Pulm Crit Care 2012;4:51-2.

*The opinions expressed in this editorial are the opinions of the authors and not necessarily the opinions of the Southwest Journal of Pulmonary and Critical Care or the Arizona, New Mexico or Colorado Thoracic Societies.

Reference as: Robbins RA, Thomas AR. Choosing wisely-where is the choice? Southwest J Pulm Crit Care. 2013;6(6):272-4. PDF

The State of Pulmonary and Critical Care in the Southwest

Sunday afternoon at the American Thoracic Society International Conference has two sessions we usually attend – the Great Cases Conference and the Awards Session. These are fun sessions. The Great Cases Conference is a chance to test your diagnostic acumen against master clinicians. The awards session is when leaders in pulmonary, critical care and sleep are acknowledged for their accomplishments and/or public service.

The Great Cases Conference was co-chaired by Dona Upson from New Mexico. The master clinicians included Marvin Schwarz from Colorado, Tom Colby from Arizona, and John Newell, who until recently was from Colorado. Sharon Rounds from Brown was another of the master clinicians and did her pulmonary/critical care training in Colorado.

The awards session was chaired by Monica Kraft, who was a pulmonary fellow and later faculty member at the University of Colorado and National Jewish Health (NJH). Jonathan Samet, a former resident, faculty member and division chief at the University of New Mexico, was presented the Edward Livingston Trudeau Medal. The Amberson Lecturer was David Schwartz from the University of Colorado. Polly Parsons, a graduate of the University of Arizona College of Medicine, who did her residency and pulmonary fellowship at Colorado, and later was a faculty member at Colorado, was presented the ATS distinguished service award. Allen Thomas was a resident and pulmonary fellow in Phoenix and practices at the Phoenix VA, and was presented the ATS Clinician of the Year. Abderrahmane E. Amine Temmar from Albuquerque was one of the other two finalists for clinician of the year. Kay Kreiss, the recipient of the Public Health Service award, was on faculty at NJH /University of Colorado for more than 14 years.  Paul Noble, a former University of Colorado fellow, was presented with a recognition award for scientific accomplishments. Although not presented until the Women’s Forum on Monday, the list is not complete without acknowledging the Elizabeth A. Rich, MD Award to Suzanne Lareau of the University of Colorado, having moved there from the Albuquerque VA.

Arizona, New Mexico and Colorado’s 13.9 million residents represent only 4.4% of the United States’ 313.9 million inhabitants. Why so many good physicians, and other clinicians, trained or reside in the Southwest is unclear. Perhaps it was pioneers in the field such as Tom Petty in Denver, Benjamin Burrows in Tucson and William and Randy Lovelace in Albuquerque who inspired so many young physicians. Regardless, the Southwest seems to be overly blessed with great pulmonary, critical care and sleep physicians. We at the Southwest Journal of Pulmonary and Critical Care wish to recognize their accomplishments and note that the state of pulmonary, critical care and sleep in the Southwest appears very good indeed.

Richard A. Robbins, M.D.

Dona J. Upson, M.D.

Carolyn H. Welsh, M.D.

Reference as: Robbins RA, Upson DJ, Welsh CH. The state of pulmonary and critical care in the Southwest. Southwest J Pulm Crit Care. 2013;6(5): 246. PDF

Doxycycline and IL-8 Modulation in a Line of Human Alveolar Epithelium: More Evidence for the Anti-Inflammatory Function of Some Antimicrobials

Beta blockers for severe systolic dysfunction; antibiotics for peptic ulcer disease.  These are just a few examples of the many unpredicted consequences of medication intervention.  Rheumatology has known of the disease modifying anti-rheumatic drug (DMARD) capacity of second generation tetracyclines including doxycycline (1). This has actually led to investigations attempting to identify organisms possibly serving as substrates for inflammatory processes including rheumatoid arthritis and even atherosclerosis. Generally, this has been unsuccessful and the conclusion that doxycycline has intrinsic anti-inflammatory properties has become suspect (2,3).

Experience with higher generation macrolides like azithromycin further lends credence to this concept of antibiotics as intrinsically anti-inflammatory (4). There is a body of data suggesting inhibition of cytokine expression by this drug. In diseases like cystic fibrosis where even very high intracellular concentrations of macrolide have no significant activity against pseudomonas species but the drug therapy does appear to modify disease course further supports this anti-inflammatory contention (5). 

Published work has suggested the beneficial anti-inflammatory effect in COPD relating this broadly to doxycycline’s inhibition of matrix metalloproteinases, MMP(s) (6).  MMP(s) have been postulated to rise as a function of the oxidative stress recurrently demonstrated in chronic obstructive pulmonary disease (COPD).  Additionally, doxycycline has demonstrated the ability to impair neutrophil migration in LPS stimulated alveolar macrophages harvested from bronchoalveolar lavage. Hoyt et al. (7) have now nicely demonstrated ex-vivo that doxycycline is capable of inhibiting IL-8 expression in a line of human lung epithelial cells stimulated by a cytomix, a potent combination of inflammatory stimulators. Importantly, this is a demonstration of measureable inhibition of an inflammatory cytokine by the tetracycline in mammalian cells.

The biologic significance of this still remains to be fully determined. In the large ECLIPSE TRIAL, the major discriminator of inflammatory modulators in COPD with inflammation was IL-6 and not IL-8 which actually decreased in the cohort of individuals with evidence of inflammation (8). Further study may reveal that doxycycline also has a suppressive effect on the former cytokine.

Broadly, MAP kinases are a group of protein kinases that participate in the signaling of stress related mediators like cytokines. A finding reported by Hoyt et al. (7) that will require further investigation concerns the decrease in p38 mitogen-activated protein kinase (p38 MAPK) in response to doxycycline. The data in this regard remains conflicting with reports suggesting p38 MAPK is involved in IL-8 transcription in a human monocyte model with exposure to Clostridium difficile toxin (9). Hoyt et al. (7) found a decrease in p38 MAPK along the absence of change in mRNA by reverse transcription-polymerase chain reaction (RT-PCR) suggesting that effect of doxycycline on IL-8 elaboration is post transcriptional. Others have reported data supporting the concept of post transcription modulation of IL-8 by doxycycline as suggested by Hoyt et al. (10). While validation with repeat studies will be necessary, the finding that IL-8 mRNA by RT-PCR was not affected by levels of doxycycline that inhibited IL-8 is noteworthy. One may conclude that IL-8 assembly at the level of the ribosome could be operative.  While it was previously presumed that the tetracyclines specifically targeted bacterial ribosomes, Robbins et al along with all the other studies support the anti-inflammatory effect of tetracyclines in human disease and demonstrates that mammalian cells are also affected by this moiety.

So Hoyt et al. (7) have added to the knowledge base by definitively demonstrating the non-antimicrobial properties of doxycycline by ex-vivo inhibition of IL-8 production in a line stimulated mammalian alveolar epithelial cells. If the RT-PCR data can be further confirmed, this inhibition of IL-8 by doxycycline appears to be a post-transcriptional mechanism. Whether p38 MAPK is a transcriptional or post-transcriptional cytokine modifier remains to be determined.

Jay E. Blum, M.D.

Chief, Pulmonary and Critical Care

Phoenix VA Medical Center

References

1. Stone M, Fortin PR, Pacheco-Tena C, Inman RD. Should tetracycline treatment be used more extensively for rheumatoid arthritis Metaanalysis demonstrates clinical benefit with reduction in disease activity. J Rheumatol. 2003;30:2112-22.
2. Anderson JL, Muhlestein JB, Carlquist J, et al. Randomized secondary prevention trial of azithromycin in patients with coronary artery disease and serological evidence for Chlamydia pneumoniae infection: The Azithromycin in Coronary Artery Disease: Elimination of Myocardial Infection with Chlamydia (ACADEMIC) study. Circulation.1999;99:1540-7.
3. Webster G, Del Rosso JQ. Anti-inflammatory activity of tetracyclines. Dermatol Clin. 2007;25:133-5.
4. Kanoh S, Rubin BK. Mechanisms of action and clinical application of macrolides as immunomodulatory medications. Clin Microbiol Rev. 2010;23:590-615.
5. Equi AC, Davies JC, Painter H, Hyde S, Bush A, Geddes DM, Alton E. Exploring the mechanisms of macrolides in cystic fibrosis.  Respir Med. 2006;100:687-97.
6. Greenwald RA, Moak SA, Ramamurthy NS, Golub LM. Tetracyclines suppress matrix metalloproteinase activity in adjuvant arthritis and in combination with flurbiprofen, ameliorate bone damage. J Rheumatol. 1992;19:927-38.
7. Hoyt JC, Ballering JG, Hayden JM, Robbins RA. Doxycycline decreases production of interleukin-8 in a549 human lung epithelial cells. Southwest J Pulm Crit Care. 2013;6:130-42.
8. Celli BR, Locantore N, Yates J, Tal-Singer R, Miller BE, Bakke P, Calverley P, Coxson H, Crim C, Edwards LD, Lomas DA, Duvoix A, MacNee W, Rennard S, Silverman E, Vestbo J, Wouters E, Agustí A; ECLIPSE Investigators. Inflammatory biomarkers improve clinical prediction of mortality in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2012;185:1065-72.
9. Warny M,  Keates AC, Keates S, Castagliuolo I,  Zacks J,  Aboudola S et al. p38 MAP kinase activation by Clostridium difficile toxin A mediates monocyte necrosis, IL-8 production, and enteritis. J Clin Invest. 2000;105:1147–56.
10. Li J, Kartha S, Iasvovskaia S, Tan A, Bhat RK, Manaligod JM, Page K, Brasier AR and Hershenson MB.  Regulation of human airway epithelial cell IL-8 expression by MAP kinases.  Am J Physiol Lung Cell Mol Physiol. 2002;283:L690-L699.

Reference as: Blum JE. Doxycycline and IL-8 modulation in a line of human alveolar epithelium: more evidence for the anti-inflammatory function of some antimicrobials. Southwest J Pulm Crit Care. 2013;6(4):184-6. PDF 

What to Expect from Obamacare

“I predict future happiness for Americans if they can prevent the government from wasting the labors of the people under the pretense of taking care of them.”

-Thomas Jefferson

The Supreme Court decision is in and the election is over. Obamacare, or the Patient Protection and Affordable Care Act (ACA), will become reality, but questions remain on what it will look like. ACA had three goals: 1. Expand coverage to the poor; 2. Control costs; and 3. Improve care. These are all laudable goals but it is unclear if they can be achieved. Experience from Federal-run health systems such as Center for Medicare and Medicaid Services (CMS) and the Veterans Administration (VA) provide some clues as do recent Federal actions and the Massachusetts health care system.

Expand Coverage to the Poor

The US has about 60 million uninsured and one of the ACA goals is to come as close as possible to achieving universal healthcare coverage. In order to do this, the ACA depends heavily on Medicaid, a joint Federal-state health benefits program, to reach the goal of near-universal health care. If every state participated, 17 million uninsured people would gain coverage through Medicaid and the Children's Health Insurance Program between 2014 and 2022, according to the Congressional Budget Office (CBO). These are often the poorest of the poor. The Federal government usually pays for about half to two-thirds of the cost of Medicaid. To encourage states to participate in the ACA, the Federal government upped payment to 100 percent of the cost of covering newly eligible people from 2014-6, after which the share will gradually go down to 90 percent in 2022 and later years.

However, the Supreme Court decision in June, which mostly upheld the ACA, gave states the right to opt out of the Medicaid expansion. At the time of this writing, roughly a third of the states have decided not to participate, a third will participate and a third are undecided (Figure 1).

 

Figure 1. State commitment to expand Medicaid eligibility as of 12/12/12.

Some governors have asked Health and Human Services if they partially expand Medicaid will the Federal Government still pay for the expansion. In response, Health and Human Services Secretary, Kathleen Sebelius, has written a letter to the Nation’s governors saying it is all or nothing. According to the CBO this lack of participation leaves up to 3 million of the poorest Americans without health coverage. Placement of bureaucratic obstacles to discourage eligible persons not to sign up as well as political bickering and their inevitable subsequent lawsuits are likely to further delay care for the eligible. Therefore, it is unclear to what extent the ACA will increase coverage to the poor but it seems unlikely to bring the US any where close to universal healthcare.

Reduce Costs

Clearly medical care costs too much. In order to control the growth in costs it is necessary to know where the growth in spending has occurred. The latest data available is from 2010 and has been the subject of a previous editorial (2). Although there are many categories of health care expenditures, the four largest and their percentages of healthcare expenditures are hospital care (31.4%), physicians (16.1%), pharmaceuticals (10.0%), and net cost of insurance (5.6%). The largest increase in absolute costs was in hospitals which accounted for 39.4% of the increase of the $101.15 billion increase compared to 2009. The largest percentage increase was in net cost of insurance at 8.4% which was much higher than the 3.9% increase overall. Drug costs were not markedly increased at a1.2% increase but the top 12 companies had 310.8 billion in sales and 49.3 billion in profits in 2012 suggesting that the pharmaceutical industry is healthy and profitable (3). Although the Obama Administration often talks tough about reducing costs, especially insurance company costs, it seems unlikely based on their history that there will be a reduction in any of these three categories.

On the other hand, physician salaries have fallen. While the income of dentists, pharmacists, registered nurses, physician assistants, and health care and insurance executives rose by an average 10.2% in 2005-10 compared 2000-4, the income of physicians decreased by 5.8% (4). Although the hourly wage of physicians remains high ($80.00/hr) and remains higher than dentists ($70.64/hr) and lawyers ($54.21/hr), the gap is closing (5-7). This is despite a shortage of physicians (5). Even though the greatest physician need is in primary care physicians, pediatricians, family practioners and general internists remain the lowest paid physicians (8).  

Based on these trends, it seems likely medical costs will continue to rise. However, payments to physicians will probably remain static or decrease. Although the consequences are unclear, the cuts in payment to physicians are not sustainable and will likely drive many physicians, especially primary care physicians, out of private practice. The other consequence may be that some physicians, most likely specialists, may not take insurance with low reimbursement such as Medicare and Medicaid. This would mean that those that can afford to pay out of pocket will receive health care while the poor, the very people the ACA was intended to help, may not. Regardless, it is unlikely that the continual focus on physician reimbursement to control costs will be successful in controlling overall medical expenditures. The 16.1% of healthcare costs attributable to physicians is simply not large enough to reduce the overall costs, especially since physicians have born the brunt of the cuts for the past few years.

The ACA also proposes to reduce costs by paying only for value- and evidence-based care based more for outcomes than procedures. However, this is the approach that has been in place for some time at CMS and has yet to reduce costs. Committees far removed from medical practice have often made poor decisions. For example, patients who need self-catherization were at one time allowed only 4 catheters per month. Some patients had excessive and expensive hospital admissions for urinary tract infections. Presumably the catheters were not properly cleaning their catheter prior to reuse which resulted in the excess hospitalizations. The policy has now been changed to allow up to 200 catheters per month.

Another example is computerized healthcare records. In a January speech, President Obama evoked the promise of new technology: “This will cut waste, eliminate red tape and reduce the need to repeat expensive medical tests," he said. However, rather than reduce costs, the opposite happened. With better documentation, physicians billed at higher levels actually increasing costs (9). Response blaming physicians was swift implying physicians committed fraud (10).

Physicians and their patients may find themselves directed to cheaper care even when evidence points to a better but more expensive alternative. As a personal example, I have congestive heart failure and take carvedilol. My insurance company, Blue Cross and Blue Shield, has denied payment for the carvedilol despite evidence that it is superior to their recommended alternative, metropolol (11). The VA and Medicare have had similar policies in place. The difference in cost is about $1/day. I pay for my carvedilol out-of-pocket because in the COMET trial it reduced mortality from 40% to 34% (11). My judgment was that a 6% increase in survival was worth the extra cost. Patients are likely to find themselves in similar situations where if they want care that is not in the guidelines, they will need to pay for it themselves whether it is evidence-based or not.

Improvement in Care

A clue to how the Obama administration plans to improve care was in the 2010 summer recess appointment of Don Berwick as Administrator of the Centers for Medicare and Medicaid Services. Prior to his appointment he was President and Chief Executive Officer of the Institute of Healthcare Improvement (IHI). IHI was a group who convinced many hospitals to adopt a number of their guidelines. These guidelines had two common themes-most were physician focused and many very weakly evidence-based (12,13). CMS began tying reimbursement and compliance with the guidelines. The financial disincentive to accurately report data induced many hospitals to lie about their data (14). Not surprisingly, compliance improved but there has been little evidence for an accompanying improvement in outcomes (14,15). Witness the recent example of central line associated blood stream infections (CLABSI). Based on hospital self-reported data, CMS announced its program reduced the rate of CLABSI (16). Within a month an article appeared in the New England Journal of Medicine reporting the program did nothing to reduce infections or any other outcomes (17).

However, there may be a glimmer of hope. Although there is a continued reliance on weakly evidence-based surrogate markers, CMS has begun looking at mortality, morbidity, length of stay and readmission rates. These patient-centered outcomes have real meaning to patients as well as affecting costs. This may finally force health care administrators to address real care issues rather than performance of surrogate, weakly evidence based guidelines such as administration of pneumococcal vaccine to adults, telling smokers not to smoke without any follow up and providing discharge instructions.

Conclusions

Overall it appears that the ACA will have minimal impact on its goals of expanding care to the poor, reducing costs or improving care for the foreseeable future. It will likely continue to cost shift reimbursement away from physicians while costs continue to rise. Almost certainly it will be entangled in political bickering, eligibility challenges and lawsuits reducing many of the benefits of the law. However, we can probably be assured that CMS will continue to rely on inaccurately reported data, quickly declare their programs successful and stay their course, despite the programs doing little to nothing for patients. When their programs focus on outcomes such as mortality, morbidity, length of stay and readmission rates, real progress can be made in improving patient care rather than “spinning” dubious results.

Richard A. Robbins, MD*

References

1. Kliff S. White House to states: on Medicaid expansion, it’s all or nothing. Available at http://www.washingtonpost.com/blogs/wonkblog/wp/2012/12/10/white-house-to-states-on-medicaid-expansion-its-all-or-nothing/  (accessed 12-13-12).
2. Robbins RA. Follow the money. Southwest J Pulm Crit Care 2012;4:19-21.
3. Fortune. Available at: http://money.cnn.com/magazines/fortune/fortune500/2012/industries/21/ (accessed 12-13-12).
4. Seabury SA, Jena AB, Chandra A. Trends in the earnings of health care professionals in the United States, 1987-2010. JAMA 2012;308:2083-5.
5. US Bureau of Labor Statistics. Avaiable at: http://www.bls.gov/ooh/healthcare/physicians-and-surgeons.htm (accessed 12-13-12).
6. US Bureau of Labor Statistics. Available at: http://www.bls.gov/ooh/healthcare/dentists.htm (accessed 12-13-12).
7. US Bureau of Labor Statistics. Available at http://www.bls.gov/ooh/legal/lawyers.htm (accessed 12-13-12).
8. Medscape. Physician compensation report 2012. Avaiable at: http://www.medscape.com/sites/public/physician-comp/2012 (accessed 12-13-12).
9. Haig S. Electronic medical records: will they really cut costs? Time 2009. Available at: http://www.time.com/time/health/article/0,8599,1883002,00.html#ixzz2FF0XBf5d (accessed 12-16-12).
10. Carlson J. HHS inspector general's office quizzes providers about EHR use. Modern Healthcare 2012. Available at: http://www.modernhealthcare.com/article/20121023/NEWS/310239946 (accessed 12-13-12).
11. Poole-Wilson PA, Swedberg K, Cleland JG, Di Lenarda A, Hanrath P, Komajda M, Lubsen J, Lutiger B, Metra M, Remme WJ, Torp-Pedersen C, Scherhag A, Skene A; Carvedilol Or Metoprolol European Trial Investigators. Comparison of carvedilol and metoprolol on clinical outcomes in patients with chronic heart failure in the Carvedilol Or Metoprolol European Trial (COMET): randomised controlled trial. Lancet. 2003 ;362:7-13.
12. Padrnos L, Bui T, Pattee JJ, Whitmore EJ, Iqbal M, Lee S, Singarajah CU, Robbins RA. Analysis of overall level of evidence behind the Institute of Healthcare Improvement ventilator-associated pneumonia guidelines. Southwest J Pulm Crit Care 2011;3:40-8.
13. Hurley J, Garciaorr R, Luedy H, Jivcu C, Wissa E, Jewell J, Whiting T, Gerkin R, Singarajah CU, Robbins RA. Correlation of compliance with central line associated blood stream infection guidelines and outcomes: a review of the evidence. Southwest J Pulm Crit Care 2012;4:163-73.
14. Meddings JA, Reichert H, Rogers MA, Saint S, Stephansky J, McMahon LF. Effect of nonpayment for hospital-acquired, catheter-associated urinary tract infection: a statewide analysis. Ann Intern Med 2012;157:305-12.
15. Robbins RA. The emperor has no clothes: the accuracy of hospital performance data. Southwest J Pulm Crit Care 2012;5:203-5.
16. Agency for Healthcare Quality and Research. Available at: http://www.ahrq.gov/qual/clabsiupdate/ (accessed 12-13-12).
17. Lee GM, Kleinman K, Soumerai SB, Tse A, Cole D, Fridkin SK, Horan T, Platt R, Gay C, Kassler W, Goldmann DA, Jernigan J, Jha AK. Effect of nonpayment for preventable infections in U.S. hospitals. N Engl J Med 2012;367:1428-37.

*The views expressed are those of the author and do not necessarily represent those of the Arizona, New Mexico or Colorado Thoracic Societies.

Reference as: Robbins RA. What to expect from Obamacare. Southwest J Pulm Crit Care. 2013;6(1):23-28. PDF 

The Terrific Twos! Annual Report from the Editor

With the end of 2012, the Southwest Journal of Pulmonary and Critical Care (SWJPCC) completed its second year of operation. Our first manuscript was posted on November 11, 2010. We posted 8 manuscripts our first year, 68 during 2011, and 113 during 2012 (Table 1).  

Table 1. Postings by SWJPCC 2010-2.

 

Accompanying our increase in manuscripts, our readership has steadily grown to about 3000/month unique IP addresses and about 9000/month page views (the number of files that are requested from a site, also known as “hits”) (Figure 1).

Figure 1. Growth of unique IP addresses and page views by month during 2012.

We had some big changes in 2012. Some of which are listed below:

• New Mexico and Colorado Thoracic Societies partnered with Arizona in SWJPCC.
• SWJPCC is listed in the Directory of Open Access Journals.
• The Case of the Month was expanded to cases by including a Pulmonary and Critical Care Case of the Month in addition to Imaging.
• A Sleep Board Review Question section was added.
• A “News” section was launched.
• A Medical Image of the Week section was inaugurated.

Many need to be thanked. First, thanks to our authors. You took a chance on a new journal and we appreciate the opportunity to publish your work. Second, thanks to our reviewers.  SWJPCC, like all journals, relies upon expert reviewers in order to publish the highest quality manuscripts. We thank the reviewers for their time and effort in the prompt submission of their reviews. A list of reviewers for 2012 is below.

• David Baratz
• Lee Brown
• Richard Carlson
• John Costantino
• Steven Curry
• Thomas Daniels
• Venu Gopal
• Michael Garrett
• Mark Gotfried
• Michael Habib
• Michelle Harkins
• Steve Klotz
• Kenneth Knox
• Manoj Mathew
• Rakesh Nanda
• Huw Owen-Reece
• James Parish
• George Parides
• Lillibeth Pineda
• Stuart Quan
• Robert Raschke
• Richard Robbins
• Clement Singarajah
• Allen Thomas
• Dona Upson
• Laszlo Vaszar
• Zahid Virk
• Carolyn Welsh
• Lewis Wesselius

Our gratitude goes to the Arizona, New Mexico, and Colorado Thoracic Societies for their support. Thanks to our associate editors who have put in much more work than we had the right to ask. A special note of thanks to those who continue to do regular features in SWJPCC-Bob Raschke and Manoj Mathew for the critical care and pulmonary journal clubs; Mike Gotway, Lew Wesselius and Bob Raschke for the cases of the month; Rohit Budhiraja for the Sleep Question of the Month; and Ken Knox for the Medical Image of the Week; and Peter Wagner for his wine column, Slurping Around with PDW. SWJPCC acknowledges the Phoenix Pulmonary and Critical Care Research and Education Foundation which has provided the monetary support for SWJPCC. Last, and most importantly, thanks to our readers. Please visit as often as you can and feel free to provide us with your input.

What’s ahead for 2013? Yogi Berra was probably right, “It's tough to make predictions, especially about the future.”  We hope to improve the content, especially the scientific content, for 2013, but we will continue to emphasize clinical medicine and education. With the help of Ken Knox, Skip Harris, Mike Gotway, Lewis Wesselius and Clement Singarajah, we hope to begin offering Continuing Medical Education (CME) in the early part of 2013. Although we have learned that the is future hard to predict, we sincerely believe that with your help the SWJPCC will continue to grow and improve.

Richard A. Robbins, MD

Editor, SWJPCC

Reference as: Robbins RA. The terrific twos! annual report from the editor. Southwest J Pulm Crit Care 2013;6(1):1-3. PDF 

Maintaining Medical Competence

“I am free, no matter what rules surround me…because I know that I alone am morally responsible for everything I do.”― Robert A. Heinlein

I recently renewed my Arizona medical license and meet all the requirements. I far exceed the required CME hours and have no Medical Board actions, removal of hospital privileges, lawsuits, or felonies. None of the bad things are likely since I have not seen patients since July 1, 2011 and I no longer have hospital privileges. However, this caused me to pause when I came to the question of “Actively practicing”? A quick check of the status of several who do not see patients but are administrators, retired or full time editors of other medical journals revealed they were all listed as “active”. I guess that “medical journalism” is probably as much a medical activity as “administrative medicine” which is recognized by the Arizona Medical Board. This got me to thinking about competence and the Medical Board’s obligation to ensure competent physicians.

Medical boards focused on preventing the unlicensed practice of medicine by “quacks” and “charlatans” in the first half of the Twentieth Century. The Boards evolved over time to promote higher standards for undergraduate medical education; require assessment of knowledge and skills to qualify for initial licensure; and develop and enforce standards for professional practice. Beginning with New Mexico in 1971, nearly all state medical boards require a prescribed number of continued medical education (CME) hours with Colorado being a notable exception. Colorado’s lack of CME requirements goes against the recent trends. In 2010 the Federation of State Medical Boards (FSMB) House of Delegates voted to adopt a framework for maintenance of licensure to address concerns among policymakers and regulators (1). The FSMB’s framework contains three components: 1. reflective self assessment; 2. assessment of knowledge and skills; and 3. performance in practice.

Self-reflection has long been a mainstay of good medical practice. However, the requirement is vague and most evidence suggests that physicians are not very good at it (2). Assessment and reassessment of knowledge and skills has been present in most medical specialty and subspecialty boards for some time. Furthermore, actively practicing physicians are required to undergo periodic peer review and reapplication for hospital privileges. Further testing and assessment seems costly and largely unneeded. However, medical licensure is above all about seeing and treating patients. What is new is FSMB’s recognition of the importance of active medical practice in determining medical competence. In many instances, policymakers such as chiefs of staff, hospital board members, administrators or members of guideline writing committees have been non- or very limited practicing physicians. Their decisions have often been fundamentally flawed. Quality has been frequently politically defined rather than patient centered and evidence based. In too many cases, hastily adopted guidelines are proven wrong and even potentially dangerous to patients (3).

A physician who directs care should be subject to the “Continued Competency Rule” which is used in Colorado (4). This rule requires that a physician, “if not having engaged in active practice for two or more years…be able to demonstrate continued competency”. It needs to be recognized that those who meet this standard are only competent in their own area of practice. For example, a pulmonary and critical care physician has no business directing neurosurgical care or formulating orthopedic guidelines. Administrative medicine, and for that matter, medical journalism, would do not meet this standard of competency since neither involves taking responsibility for the care of patients. The requirement for physician administrators to be really active in the practice of medicine may be one key to improved medical care and competence. At least it should make them think about directing care or mandating a guideline that they, themselves have to follow.

Richard A. Robbins, MD*

References

1. Chaudhry HJ, Talmage LA, Alguire PC, Cain FE, Waters S, Rhyne JA. Maintenance of licensure: supporting a physician's commitment to lifelong learning. Ann Intern Med 2012;157:287-9.
2. Davis DA, Mazmanian PE, Fordis M, Van Harrison R, Thorpe KE, Perrier L. Accuracy of physician self-assessment compared with observed measures of competence: a systematic review. JAMA 2006;296:1094-102.
3. Robbins RA, Thomas AR, Raschke RA. Guidelines, recommendations and improvement in healthcare. Southwest J Pulm Crit Care 2011;2:34-37.
4. http://www.dora.state.co.us/medical/ (accessed 11/5/12).

* The views expressed are those of the author and do not necessarily represent the views of the Arizona, New Mexico or Colorado Thoracic Societies.

Reference as: Robbins RA. Maintaining medical competence. Southwest J Pulm Crit Care 2012;5:266-7. PDF

Interference with the Patient–Physician Relationship

“Life is like a boomerang. Our thoughts, deeds and words return to us sooner or later, with astounding accuracy.”-Brant M. Bright, former project leader with IBM

A recent sounding board in the New England Journal of Medicine discussed legislative interference with the patient-physician relationship (1).  The authors, the executive staff leadership of the American Academy of Family Physicians, the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, the American College of Physicians, and the American College of Surgeons believe that legislators should abide by principles that put patients’ best interests first. Critical to achieving this goal is respect for the importance of scientific evidence, patient autonomy, and the patient-physician relationship. According to the authors, lawmakers are increasingly intruding into the realm of medical practice, often to satisfy political agendas without regard to established, evidence-based guidelines for care.

The article goes on to cite examples including:

1. The Florida Firearm Owners’ Privacy Act, which substantially impaired physicians’ ability to deliver gun-safety messages to patients.
2. New York legislation requiring physicians to offer terminally ill patients information and counseling regarding palliative care and end-of-life options.
3. A Virginia bill requiring women to undergo ultrasonography before an abortion including mandated transvaginal ultrasonography in some instances.
4. Pennsylvania, Ohio, Colorado, and Texas legislation limiting a physician’s ability to disclose information about exposure to chemicals such as benzene, toluene, ethylbenzene, and xylene used in the process of hydraulic fracturing (“fracking”).

The authors condemn these actions that undermine physician autonomy and the fundamental principles of respect for patient autonomy, beneficence, nonmaleficence, and justice that shape physicians’ actions and behavior. The authors go on to state that “laws and regulations are blunt instruments… that reduce health care decisions to a series of mandates …for political or other reasons unrelated to the scientific evidence and counter to the health care needs of patients”. However, these legislative actions are an extension of the trend where multiple individuals and groups have increasingly dictated patient care.

It would be remiss not to point out that those clinician groups have been as guilty of dictating healthcare as some of the politicians by publishing or endorsing mandates for care. As the authors state mandates “do not allow for the infinite array of exceptions-cases in which the mandate may be unnecessary, inappropriate, or even harmful to an individual patient”. Although the authors would likely argue that they publish guidelines rather than mandates, their guidelines have as much authority as laws given that both threaten a physician’s ability to practice. Penalties for noncompliance with guidelines such as removing hospital privileges, reducing payments or listing physicians in the National Practioner Database are as much a threat to physicians as legislative action.

These clinician groups would also likely argue that their guidelines are evidence-based and in the patient’s best interests. However, there are multiple instances where the mandates are not evidence based and ineffective (e.g., pneumococcal 23 polyvalent vaccine in adults) (2-4) or even harmful (e.g., tight control of glucose in the ICU) (5). Patient autonomy and individual needs, values, and preferences must be respected. Physicians must have the ability and freedom to treat their patients “freely and confidentially, to provide patients with factual information relevant to their health, to fully answer their patients’ questions, and to advise them on the course of best care without the fear of penalty” (1).

These clinician groups should speak out against political mandates or when the scientific evidence is premature, weak or contradictory regardless of the source. Medical guidelines should have patients' best interests at heart and not political agendas whether from politicians or others. Importantly, these clinician groups should “recognize the infinite array of exceptions” to each mandate or guideline. Finally, they should condemn the practice of allowing regulatory agencies to promote a political or financial agenda by threatening physicians to conform to the ever increasing numbers of mandates and guidelines that are based on poor quality evidence. Those that are members of the American Academy of Family Physicians, the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, the American College of Physicians, or the American College of Surgeons who agree that mandates undermine the physician-patient relationship and ultimately adversely affect patient care should speak loudly to their executive staff leaders to ensure their voices are heard. Better ways of informing clinicians of best current practice are needed, but also needed are ways of making the accomplishment of best practices easy and rewarding, rather than punitive.

Richard A. Robbins, MD*

Editor, SWJPCC

References

1. Weinberger SE, Lawrence HC 3rd, Henley DE, Alden ER, Hoyt DB. Legislative interference with the patient-physician relationship. N Engl J Med 2012;367:1557-9.t
2. Fine MJ, Smith MA, Carson CA, Meffe F, Sankey SS, Weissfeld LA, Detsky AS, Kapoor WN. Efficacy of pneumococcal vaccination in adults. A meta-analysis of randomized controlled trials. Arch Int Med 1994;154:2666-77.
3. Dear K, Holden J, Andrews R, Tatham D. Vaccines for preventing pneumococcal infection in adults. Cochrane Database Sys Rev 2003:CD000422.
4. Huss A, Scott P, Stuck AE, Trotter C, Egger M. Efficacy of pneumococcal vaccination in adults: a meta-analysis. CMAJ 2009;180:48-58.
5. Robbins RA, Singarajah CU. Critical care review: the high price of sugar. Southwest J Pulm Crit Care 2011;3:78-86

The views expressed in this editorial are those of the author and not necessarily the views of the Arizona, New Mexico or Colorado Thoracic Societies.

Reference as: Robbins RA. Interference with the patient-physician relationship. Southwest J Pulm Crit Care 2012;5:253-5. PDF 

Guidelines for Starting Today’s Private Practice

Starting a new practice may seem like a daunting task. The purpose of this editorial is to demystify the process of creating a new practice from the beginning. The cardinal rule is to keep costs low and not to outsource work that can easily be performed by any competent physician and staff. You do not need a manager, lawyer, business partner, coder or biller individually; you may be able to perform many of these services yourself. What you do need is a commitment to making your practice a success. 

Do not spend too much on your office space, furnishings or equipment. Start with the bare essentials. Immediately start applying to all insurance companies especially Medicare. Request an employer identification number. Set up a basic business banking account and submit the account number to the insurance companies you plan to work with.

You can purchase an entire electronic healthcare record (EHR) system or you can create your own EHR using basic word processing software, a free electronic prescription account and inexpensive billing software. Purchase malpractice, business and personal health insurance. Consider using a temp agency for staffing. 

High quality notes and good physician communication is paramount to success. Give community lectures and grand rounds at local hospitals. Introduce yourself to physicians by joining the local medical society, visiting other practices, applying for medical staff privileges and mailing an introduction letter. With the help of this paper you will be able to create your own private practice without delay.

Evan D. Schmitz, MD (evandschmitz@gmail.com)*

April Y. Schmitz, RN*

Hoan P. Tran, MD**

* The authors are in private practice in Richland, Washington and have no conflict of interest to declare.

** The author is in private practice in Yakima, Washington and has no conflict of interest to declare.

The views expressed are those of the authors and do not necessarily represent the views of the Arizona, New Mexico or Colorado Thoracic Socieities.

Reference as: Schmitz ED, Schmitz AY, Tran HP. Guidelines for starting today's private practice. Southwest J Pulm Crit Care 2012;5:229. PDF

The Emperor Has No Clothes: The Accuracy of Hospital Performance Data

Several studies were announced within the past month dealing with performance measurement. One was the Joint Commission on the Accreditation of Healthcare Organizations (Joint Commission, JCAHO) 2012 annual report on Quality and Safety (1). This includes the JCAHO’s “best” hospital list. Ten hospitals from Arizona and New Mexico made the 2012 list (Table 1).

Table 1. JCAHO list of “best” hospitals in Arizona and New Mexico for 2011 and 2012.

This compares to 2011 when only six hospitals from Arizona and New Mexico were listed. Notably underrepresented are the large urban and academic medical centers. A quick perusal of the entire list reveals that this is true for most of the US, despite larger and academic medical centers generally having better outcomes (2,3).

This raises the question of what criteria are used to measure quality. The JCAHO criteria are listed in Appendix 2 at the end of their report. The JCAHO criteria are not outcome based but a series of surrogate markers. The Joint Commission calls their criteria “evidence-based” and indeed some are, but some are not (2). Furthermore, many of the Joint Commission’s criteria are bundled. In other words, failure to comply with one criterion is the same as failing to comply with them all. They are also not weighted, i.e., each criterion is judged to be as important as the other. An example where this might have an important effect on outcomes might be pneumonia. Administering an appropriate antibiotic to a patient with pneumonia is clearly evidence-based. However, administering the 23-polyvalent pneumococcal vaccine in adults is not effective (4-6). By the Joint Commission’s criteria administering pneumococcal vaccine is just as important as choosing the right antibiotic and failure to do either results in their judgment of noncompliance.

Previous studies have not shown that compliance with the JCAHO criteria improves outcomes (2,3). Examination of the US Health & Human Services Hospital Compare website is consistent with these results. None of the “best” hospitals in Arizona or New Mexico were better than the US average in readmissions, complications, or deaths (7).

A second announcement was the success of the Agency for Healthcare Quality and Research’s (AHRQ) program on central line associated bloodstream infections (CLABSI) (8). According to the press release the AHRQ program has prevented more than 2,000 CLABSIs, saving more than 500 lives and avoiding more than $34 million in health care costs. This is surprising since with the possible exception of using chlorhexidine instead of betadine, the bundled criteria are not evidence-based and have not correlated with outcomes (9). Examination of the press release reveals the reduction in mortality and the savings in healthcare costs were estimated from the hospital self-reported reduction in CLABSI.

A clue to the potential source of these discrepancies came from an article published in the Annals of Internal Medicine by Meddings and colleagues (10). These authors studied urinary tract infections which were self-reported by hospitals using claims data. According to Meddings, the data were “inaccurate” and “are not valid data sets for comparing hospital acquired catheter-associated urinary tract infection rates for the purpose of public reporting or imposing financial incentives or penalties”. The authors propose that the nonpayment by Medicare for “reasonably preventable” hospital-acquired complications resulted in this discrepancy. There is no reason to assume that data reported for CLABSI or ventilator associated pneumonia (VAP) is any more accurate.

These and other healthcare data seem to follow a trend of bundling weakly evidence-based, non-patient centered surrogate markers with legitimate performance measures. Under threat of financial penalty the hospitals are required to improve these surrogate markers, and not surprisingly, they do. The organization mandating compliance with their outcomes joyfully reports how they have improved healthcare saving both lives and money. These reports are often accompanied by estimates, but not measurement, of patient centered outcomes such as mortality, morbidity, length of stay, readmission or cost. The result is that there is no real effect on healthcare other than an increase in costs. Furthermore, there would seem to be little incentive to question the validity of the data. The organization that mandates the program would be politically embarrassed by an ineffective program and the hospital would be financially penalized for honest reporting.

Improvement begins with the establishment of guidelines that are truly evidence-based and have a reasonable expectation of improving patient centered outcomes. Surrogate markers should be replaced by patient-centered outcomes such as mortality, morbidity, length of stay, readmission, and/or cost. The recent "pay-for-performance" ACA provision on hospital readmissions that went into effect October 1 is a step in the right direction. The guidelines should not be bundled but weighted to their importance. Lastly, the validity of the data needs to be independently confirmed and penalties for systematically reporting fraudulent data should be severe. This approach is much more likely to result in improved, evidence-based healthcare rather than the present self-serving and inaccurate programs without any benefit to patients.

Richard A. Robbins, MD*

Editor, Southwest Journal of Pulmonary and Critical Care

References

1. Available at: http://www.jointcommission.org/assets/1/18/TJC_Annual_Report_2012.pdf (accessed 9/22/12).
2. Robbins RA, Gerkin R, Singarajah CU. Relationship between the Veterans Healthcare Administration hospital performance measures and outcomes. Southwest J Pulm Crit Care 2011;3:92-133.
3. Rosenthal GE, Harper DL, Quinn LM. Severity-adjusted mortality and length of stay in teaching and nonteaching hospitals. JAMA 1997;278:485-90.
4. Fine MJ, Smith MA, Carson CA, Meffe F, Sankey SS, Weissfeld LA, Detsky AS, Kapoor WN. Efficacy of pneumococcal vaccination in adults. A meta-analysis of randomized controlled trials. Arch Int Med 1994;154:2666-77.
5. Dear K, Holden J, Andrews R, Tatham D. Vaccines for preventing pneumococcal infection in adults. Cochrane Database Sys Rev 2003:CD000422.
6. Huss A, Scott P, Stuck AE, Trotter C, Egger M. Efficacy of pneumococcal vaccination in adults: a meta-analysis. CMAJ 2009;180:48-58.
7. http://www.hospitalcompare.hhs.gov/ (accessed 9/22/12).
8. http://www.ahrq.gov/news/press/pr2012/pspclabsipr.htm (accessed 9/22/12).
9. Hurley J, Garciaorr R, Luedy H, Jivcu C, Wissa E, Jewell J, Whiting T, Gerkin R, Singarajah CU, Robbins RA. Correlation of compliance with central line associated blood stream infection guidelines and outcomes: a review of the evidence. Southwest J Pulm Crit Care 2012;4:163-73.
10. Meddings JA, Reichert H, Rogers MA, Saint S, Stephansky J, McMahon LF. Effect of nonpayment for hospital-acquired, catheter-associated urinary tract infection: a statewide analysis. Ann Intern Med 2012;157:305-12.

*The views expressed are those of the author and do not necessarily represent the views of the Arizona or New Mexico Thoracic Societies.

Reference as: Robbins RA. The emperor has no clothes: the accuracy of hospital performance data. Southwest J Pulm Crit Care 2012;5:203-5. PDF

Getting the Best Care at the Lowest Price

“Computers make it easier to do a lot of things, but most of the things they make it easier to do don't need to be done.”- Andy Rooney

A recent report from the IOM Institute of Medicine (IOM) claims that $750 billion, or about 30% of healthcare expenditures is wasted each year (1). This attention-grabbing statistic is reminiscent of the oft-quoted figure of 44,000-98,000 deaths attributable to medical errors annually from the 2000 IOM report titled “To Err Is Human: Building a Safer Health System” (2). The IOM estimate of deaths was based on two studies that used the Harvard Medical Practice Study methodology (3-6). Nurses reviewed charts and using preset criteria cases referred charts to physicians who had undergone a short training course. The physicians judged whether the adverse event was due to a medical error and whether the error contributed to the patient’s death. The incidence of deaths from medical errors was double in New York compared to Utah and Colorado resulting in the IOM’s high and low estimate. I remember reading the studies and thinking that both had problems. The physician reviewers were often outside the specialty area involved (e.g., nonsurgeons reviewing surgical cases); the criteria for error and whether it contributed to death were not clearly defined; and the results were inconsistent (were physicians from New York really twice as negligent as those from Utah and Colorado?). My impression was that no one would believe these flawed studies. I was very wrong. The IOM report helped spark an ongoing campaign for patient safety resulting in a number of interventions. Most were focused on physicians, some were expensive, and to date, it is unclear whether they have improved outcomes or wasted resources.

Now the IOM has published that an inefficient, extraordinarily complex, and slow-to-change US healthcare system wastes huge amounts of money (Table 1) (1).

Table 1. IOM estimates of wasted healthcare dollars.

Although the validity of the estimates is uncertain, most in healthcare would agree that a large portion of healthcare dollars are wasted. The report implies much of this inefficiency is due to clinicians because they are slow-to-change, inefficient and unable to keep up with the explosion in healthcare knowledge. Because of these limitations, physicians often mismanage the patient resulting in the waste of dollars noted above. In the healthcare system envisioned by the IOM, electronic health records (EHRs) would bring the research contained in more than 750,000 journal articles published each year to the point of care. Since it would be impossible for a clinician to read all 750,000 articles these would be communicated to the clinicians as guidelines.

Over the past decade, a remarkable number of laws, rules, regulations, and new ways of doing business have hit physicians (7). Each, when viewed alone, looks very reasonable, but, taken in aggregate, they are undermining the profession and medical care. Healthcare has become more expensive and physicians have shouldered this blame despite losing much of their autonomy. The IOM recommendations on computers may be another in the death by a thousand cuts that independently thinking physicians are receiving.

Although I’m resentful of the IOM report’s implications, bringing computers and EHRs to the clinic is a good idea. However, as a retired VA physician I have repeatedly heard how the “magic” of the computer can solve problems. The VA long ago installed an electronic health record with a set of guidelines that anyone could follow. Certainly improved efficiency and reduced costs would shortly follow. Unfortunately, this does not appear to be the case. When the VA EHR was instituted the numbers of physicians and nurses within the VA declined although the numbers of total employees increased (8). At least part of the increase was due to installation and maintenance of an EHR. At the same time an ever increasing number of guidelines were placed on the computer. Costs to ensure compliance and bonuses paid to administrators for compliance further escalated expenses. Furthermore, the guidelines caused a marked consumption of clinician time. According to one estimate, compliance with the source of many of the VA guidelines, the US Preventative Services Task Force, would require 4-7 hours of additional clinician time per day (9). Clearly, this was unsustainable so further money was allocated to hire healthcare technicians to comply with many of the guidelines. Compliance improved but efficiency, costs, morbidity or mortality did not (10). Furthermore, an unexpected increase in healthcare expenditures occurred outside the VA as a consequence of EHRs. A recent report from the Office of Inspector General of Health and Human Services notes an increase in higher level billing codes in Medicare patients (11). Experts say EHR technology resulted in the increase because of its super-charting capabilities (12). Therefore, it seems unlikely that EHRs as currently utilized will improve efficiency or lower costs.

Much to their credit, the IOM seems to recognize these limitations when they say, "Given such real-world impediments, initiatives that focus merely on incremental improvements and add to a clinician's daily workload are unlikely to succeed” (1). The report goes on to say that instead, the entire infrastructure and culture of healthcare must be reconfigured for significant change to occur. I would agree. Previous changes to improve healthcare have done nothing more than shift monies away from clinical care which will not improve patient outcomes (13). This occurred at the VA and will occur again if left unchecked. A meaningful partnership between clinicians and payers achieving and rewarding high-value care is needed. To do this physicians need considerable input, and perhaps more importantly, control of any EHR. Second, physicians need to be rewarded for good care which is centered on improved patient outcomes and not endless checklists that do little more than consume time. Failure to do so will result in inefficient and more costly care and not in the improvements promised by the IOM.

Richard A. Robbins, MD*

Editor, SWJPCC

References

1. Smith M, Saunders R, Stuckhardt L, McGinnis JM. Best Care at Lower Cost: The Path to Continuously Learning Health Care in America. Washington, DC: National Academy Press. 2000. Available at: http://www.iom.edu/Reports/2012/Best-Care-at-Lower-Cost-The-Path-to-Continuously-Learning-Health-Care-in-America.aspx (accessed 9/8/12). 
2. Kohn LT, Corrigan JM, Donaldson MS.  To Err Is Human: Building A Safer Health System.  Washington, DC: National Academy Press. 2000. Available at: http://www.nap.edu/openbook.php?isbn=0309068371 (accessed 9/8/12). 
3. Hiatt HH, Barnes BA, Brennan TA, et al. A study of medical injury and medical malpractice. N Engl J Med 1989;321:480-4.
4. Brennan TA, Leape LL, Laird NM, Hebert L, Localio AR, Lawthers AG, Newhouse JP, Weiler PC, Hiatt HH. Incidence of adverse events and negligence in hospitalized patients. Results of the Harvard Medical Practice Study I. N Engl J Med 1991;324:370-6.
5. Leape LL, Brennan TA, Laird N, Lawthers AG, Localio AR, Barnes BA, Hebert L, Newhouse JP, Weiler PC, Hiatt H. The nature of adverse events in hospitalized patients. Results of the Harvard Medical Practice Study II. N Engl J Med 1991;324:377-84.
6. Thomas EJ, Studdert DM, Burstin HR, Orav EJ, Zeena T, Williams EJ, Howard KM, Weiler PC, Brennan TA. Incidence and types of adverse events and negligent care in Utah and Colorado. Med Care 2000;38:261-71.
7. Kellner KR. Physician killed by ducks. Chest 2005;127:695-6.
8. Robbins RA. Profiles in medical courage: of mice, maggots and Steve Klotz. Southwest J Pulm Crit Care 2012;4:71-7.
9. Yarnall KS, Pollak KI, Østbye T, Krause KM, Michener JL. Primary care: is there enough time for prevention? Am J Public Health 2003;93:635-41.
10. Robbins RA, Gerkin R, Singarajah CU. Relationship between the Veterans Healthcare Administration hospital performance measures and outcomes. Southwest J Pulm Crit Care 2011;3:92-133.
11. Office of Inspector General. Coding trends of Medicare evaluation and management services. Available at: http://oig.hhs.gov/oei/reports/oei-04-10-00180.asp (accessed 9-8-12).
12. Lowes R. Are Physicians Coding Too Many 99214s? Medscape Medical News. Available at: http://www.medscape.com/viewarticle/767732 (accessed 9-8-12).
13. Robbins RA, Gerkin R, Singarajah CU. Correlation between patient outcomes and clinical costs in the VA healthcare system. Southwest J Pulm Crit Care 2012;4:94-100.

*The views expressed in this editorial are those of the author and do not necessarily represent the views of the Arizona or New Mexico Thoracic Societies.

Reference as: Robbins RA. Getting the best care at the lowest price. Southwest J Pulm Crit Care 2012;5:145-8. (Click here for a PDF version of the editorial)

A New Paradigm to Improve Patient Outcomes

A Tongue-in-Cheek Look at the Cost of Patient Satisfaction

A landmark article entitled “The cost of satisfaction: a national study of patient satisfaction, health care utilization, expenditures, and mortality” was recently published in the Archives of Internal Medicine by Fenton et al. (1). The authors conducted a prospective cohort study of adult respondents (n=51,946) to the 2000 through 2007 national Medical Expenditure Panel Survey. The results showed higher patient satisfaction was associated with higher admission rates to the hospital, higher overall health care expenditures, and increased mortality.

The higher costs are probably not surprising to many health care administrators. Programs to improve patient satisfaction such as advertising, valet parking, gourmet meals for patients and visitors, massages, never-ending patient and family satisfaction surveys, etc. are expensive and would be expected to increase costs. Some would argue that these costs are simply the price of competing for patients in the present health care environment. Although the outcomes are poorer, substituting patient satisfaction as a surrogate marker for quality of care is probably still valid as a business goal (2). Furthermore, administrators and some healthcare providers are paid bonuses based on patient satisfaction. These bonuses are necessary to maintain salaries at a level to attract the best and brightest.

Although it seems logical that most ill patients wish to live and get well as quickly and cheaply as possible, the Archives article demonstrates that this is a fallacy. Otherwise, higher patient satisfaction would clearly correlate with lower mortality, admission rates and expenses. Since the hospitals and other health care organizations are here to serve the public, some would argue that giving the patients what they want is more important that boring outcomes such as hospital admission rates, costs and mortality.

The contention of this study – that dissatisfaction might improve patient survival – may have biological plausibility.  Irritation with the healthcare process might induce adrenal activation, with resulting increases in beneficial endogenous catecholamines and cortisol.  The resulting increase in global oxygen delivery might reduce organ failure.  Furthermore, the irritated patient is less likely to consent to unnecessary medical procedures and is therefore protected from ensuing complications.  An angry patient is likely to have less contact with healthcare providers who are colonized with potentially dangerous multi-drug resistant bacteria.

Specific bedside practices can be implemented in order to increase patient dissatisfaction, and thereby benefit mortality.   Nurses can concentrate on techniques of sleep deprivation such as waking the patient to ask if they want a sleeping pill.  Third year medical students can be employed to start all IVs and perform all lumbar punctures.  Attending physicians can do their part by being aloof and standoffish.  For instance, a patient suffering an acute myocardial infarction might particularly benefit from hearing about the minor inconveniences the attending suffered aboard a recent south Pacific cruise ship – “I ordered red caviar, and they brought black!”  During the medical interview, non-pregnant women should always be asked “when is the baby due?”  Repeatedly confusing the patient’s name, or calling them by multiple erroneous names on purpose, can heighten their sense of insecurity.  Simply making quotation signs with your fingers whenever the physician refers to themselves as their “doctor” can be quite off-putting. 

Simple props can be useful.  Wads of high-denomination cash, conspicuously bulging from all pockets of the attending’s white coat, can promote a sense of moral outrage.  Conspicuously placing a clothespin on your nose upon entering the patient’s room can be quite effective.  Simply placing your stethoscope in ice water for a few minutes before applying it to the patient’s bare chest can make a difference   

Other more innovative techniques might arise.  Charging the patient in cash for each individual medical intervention might be quite useful, emphasizing the magnitude of overcharging.  This would be made apparent to the patient who for instance might be asked to pay $40 cash on the barrelhead for a single aspirin pill.

Often the little things make a big difference – dropping a pile of aluminum food trays on the floor at 4 AM, clamping the Foley tube, purposely ignoring requests for a bedpan, or making the patient NPO for extended periods for no apparent reason can be quite effective. 

However, we fear that health care professionals may have difficulty overcoming their training to be responsive to patients. Therefore, we suggest a different strategy to National health care planners seeking to reduce costs and improve patient mortality, what we term the designated institutional offender (DIO). A DIO program where an employee is hired to offend patients would likely be quite cost effective. The DIO would not need expensive equipment or other resources. The DIO role is best suited for someone with minimal education and a provocative attitude. Only the most deficient and densest (as opposed to the best and brightest) should be hired.

Clearly, an authoritative group must be formed to establish guidelines and bundles for both the DIO and healthcare providers. We suggest formation of the Institute of Healthcare Irritation, or IHI.  They could certify DIOs to insure that the 7 habits of highly offensive people are used (3).  IHI can also establish clinical practice bundles like the rudeness bundle, the physical discomfort bundle, the moral outrage bundle, etc.

We suggest the following as an example to muster compliance with the physical discomfort bundle. The patient must be documented to be experiencing:

• Hunger
• Thirst
• Too cold (or too hot)
• Sleep deprivation
• Drug-related constipation
• And the inability to evacuate their bladder

Patient satisfaction with even a single component indicates failure of bundle compliance. Of course a cadre of personnel will need to be hired to ensure compliance with the bundles.

Based on the evidence from the Archives article, there was a 9.1% cost differential between the highest and the lowest satisfaction quartile. Shifting patients to lower satisfaction quartiles could result in huge cost savings. If the DIO and IHI strategies to offend are particularly effective, many patients will not return for health care at all, resulting in further savings. Targeting those who are the largest consumers of care could result in even larger savings.

The DIO and IHI would also save lives. Those patients in the highest satisfaction quartile had a 26% higher mortality rate than the lowest quartile. If patients who have poor self-related health and > 3 chronic diseases are excluded, the mortality rate is 44% higher in the highest satisfaction quartile.

Administrators could now be paid bonuses for not only compliance with the IHI bundles, but also lower patient satisfaction scores, since they can argue that lower satisfaction is actually good for patients. Furthermore, the administrators should receive higher compensation since the DIO and the personnel hired to ensure compliance with the IHI guidelines would be additional employees in their administrative chain of command and administrative salaries are often based on the number of employees they supervise.   

Richard A. Robbins, MD

Robert A. Raschke, MD

References

1. Fenton JJ, Jerant AF, Bertakis KD, Franks P. The cost of satisfaction: a national study of patient satisfaction, health care utilization, expenditures, and mortality. Arch Intern Med 2012;172:405-11.
2. Browne K, Roseman D, Shaller D, Edgman-Levitan S. Analysis & commentary. Measuring patient experience as a strategy for improving primary care. Health Aff (Millwood). 2010 May;29(5):921-5
3. Bing S. The seven habits of highly offensive people. Fortune magazine available at http://money.cnn.com/magazines/fortune/fortune_archive/1995/11/27/208025/index.htm (accessed 7-7-12).

Reference as: Robbins RA, Raschke RA. A new paradigm to improve patient outcomes: a tongue-in-cheek look at the cost of patient satisfaction. Southwest J Pulm Crit Care 2012;5:33-5. (Click here for a PDF version of the editorial) 

A Little Knowledge is a Dangerous Thing

An article entitled “A Comprehensive Care Management Program to Prevent Chronic Obstructive Pulmonary Disease Hospitalizations: A Randomized, Controlled Trial” from the VA cooperative studies program was recently published in the Annals of Internal Medicine (1).  This article describes the BREATH trial mentioned in a previous editorial (2). BREATH was a randomized, controlled, multi-center trial performed at 20 VA medical centers comparing an educational comprehensive care management program to guideline-based usual care for patients with chronic obstructive pulmonary disease (COPD). The intervention included COPD education during 4 individual and 1 group sessions, an action plan for identification and treatment of exacerbations, and scheduled proactive telephone calls for case management. After enrolling 426 (44%) of the planned total of 960 the trial was stopped because there were 28 deaths from all causes in the intervention group versus 10 in the usual care group (hazard ratio, 3.00; 95% CI, 1.46 to 6.17; p = 0.002). Deaths due to COPD accounted for the largest difference (10 deaths in the intervention group versus 3 in usual care; hazard ratio, 3.60; 95% CI, 0.99 to 13.08). This trial led us to perform a meta-analysis of educational interventions in COPD (3). In this meta-analysis of 2476 subjects we found no difference in mortality between intervention and usual care groups and that the recent Annals study was heterogenous compared to the other studies.

Should the recent VA study have been stopped early? Several reports demonstrate that studies stopped early usually overestimate treatment effects (4-7). Some have even suggested that stopping trials early is unethical (7). A number of articles suggest that trials should only be stopped if predetermined statistical parameters are exceeded, with the p value for stopping set at a very low level (4-7).  There was no planned interim analysis for any outcome in the recent VA trial. The rationale for stopping a study for an adverse effect when there is no a priori reasonable link between the intervention and the adverse effect is missing in this instance.  It seems unlikely that education would actually lead to increased deaths in COPD patients.  Any effect should logically have impacted the COPD related mortality, yet there was no significant increase for COPD related deaths in the intervention group. An accompanying editorial by Stuart Pocock makes most of these points and suggests that chance was the most likely cause of the excess deaths (8).

The VA Coop Trials coordinating center told the investigators that the reason for stopping the trial was that there were “significant adverse events” in the intervention group. Inquires regarding what adverse events went unanswered. This would seem to be a breakdown in VA research oversight. The information provided to both investigators and research subjects was incomplete and would seem to be a violation of the informed consent, which states the subject would be notified of any new information that significantly altered their risk.

Lastly, investigators were repeatedly warned by the VA coordinating center that “all communications with the media should occur through your facility Public Affairs office”. It seems very unlikely that personnel in any public affairs office have sufficient research training to answer any medical, statistical or ethical inquiries into the conduct of this study.

In our meta-analysis we have shown that self-management education is associated with a reduction in hospital admissions with no indication for detrimental effects in other outcome parameters. This would seem sufficient to justify a recommendation of self-management education in COPD. However, due to variability in interventions, study populations, follow-up time, and outcome measures, data are still insufficient to formulate clear recommendations regarding the form and content of self-management education programs in COPD.

Richard A. Robbins, M.D.*

Editor, Southwest Journal of Pulmonary

   and Critical Care

References

1. Fan VS, Gaziano JM, Lew R, et al. A comprehensive care management program to prevent chronic obstructive pulmonary disease hospitalizations: a randomized, controlled trial. Ann Intern Med 2012;156:673-683.
2. Robbins RA. COPD, COOP and BREATH at the VA. Southwest J Pulm Crit Care 2011;2:27-28.
3. Hurley J, Gerkin R, Fahy B, Robbins RA. Meta-analysis of self-management education for patients with chronic obstructive pulmonary disease. Southwest J Pulm Crit Care 2012;4:?-?.
4. Pocock SJ, Hughes MD. Practical problems in interim analyses, with particular regard to estimation.Control Clin Trials 1989;10:209S-221S.
5. Montori VM, Devereaux PJ, Adhikari NK, et al. Randomized trials stopped early for benefit: a systematic review. JAMA 2005;294:2203-9.
6. Bassler D, Briel M, Montori VM, et al. Stopping randomized trials early for benefit and estimation of treatment effects: systematic review and meta-regression analysis. JAMA 2010;303:1180-7.
7. Mueller PS, Montori VM, Bassler D, Koenig BA, Guyatt GH. Ethical issues in stopping randomized trials early because of apparent benefit. Ann Intern Med. 2007;146:878-81.
8. Pocock SJ. Ethical dilemmas and malfunctions in clinical trials research. Ann Intern Med 2012;156:746-747.

*Dr. Robbins was an investigator and one of the co-authors of the Annals of Internal Medicine manuscript (reference #1).

Reference as: Robbins RA. A little knowledge is a dangerous thing. Southwest J Pulm Crit Care 2012;4:203-4. (Click here for a PDF version of the editorial) 

VA Administrators Gaming the System

On 4-23-12 the Department of Veterans Affairs (VA) Office of Inspector General (OIG) issued a report of the accuracy of the Veterans Healthcare Administration (VHA) wait times for mental health services. The report found that “VHA does not have a reliable and accurate method of determining whether they are providing patients timely access to mental health care services. VHA did not provide first-time patients with timely mental health evaluations and existing patients often waited more than 14 days past their desired date of care for their treatment appointment. As a result, performance measures used to report patient’s access to mental health care do not depict the true picture of a patient’s waiting time to see a mental health provider.” (1). The OIG made several recommendations and the VA administration quickly concurred with these recommendations. Only four days earlier the VA announced plans to hire 1900 new mental health staff (2).

This sounded familiar and so a quick search on the internet revealed that about a year ago the United States Court of Appeals for the Ninth Circuit issued a scathing ruling saying that the VA had failed to provide adequate mental health services to Veterans (3). A quick review of the Office of Inspector General’s website revealed multiple instances of similar findings dating back to at least 2002 (4-7). In each instance, unreliable data regarding wait times was cited, VA administration agreed, and no or inadequate action was taken.

Inadequate Numbers of Providers

One of the problems is that inadequate numbers of clinical physicians and nurses are employed by the VA to care for the patients. In his “Prescription for Change”, Dr. Ken Kizer, then VA Undersecretary for Health, made bold changes to the VA system in the mid 1990’s (8). Kizer cut the numbers of hospitals but also the numbers of clinicians while the numbers of patients increased (9). The result was a marked drop in the number of physicians and nurses per VA enrollee (Figure 1).

Figure 1. Nurses (squares) and physicians (diamonds) per 1000 VA enrollees for selected years (10,11).

This data is consistent with a 2011 VA survey that asked VA mental health professionals whether their medical center had adequate mental health staff to meet current veteran demands for care; 71 percent responded no. According to the OIG, VHA’s greatest challenge has been to hire psychiatrists (1). Three of the four sites visited by the OIG had vacant psychiatry positions. One site was trying to replace three psychiatrists who left in the past year. This despite psychiatrists being one of the lowest paid of the medical specialties (12). The VA already has about 1,500 vacancies in mental-health specialties. This prompted Sen. Patty Murray, Chairman of the Senate Committee on Veterans Affairs to ask about the new positions, "How are you going to ensure that 1,600 positions ... don't become 1,600 vacancies?" (13).

Administrative Bonuses

A second problem not identified by the OIG is administrative bonuses. Since 1996, wait times have been one of the hospital administrators’ performance measures on which administrative bonuses are based. According to the OIG these numbers are unreliable and frequently “gamed” (1,4-7). This includes directions from VA supervisors to enter incorrect data shortening wait times (4-7).

At a hearing before the Senate Committee on Veterans' Affairs Linda Halliday from the VA OIG said "They need a culture change. They need to hold facility directors accountable for integrity of the data." (13). VA "greatly distorted" the waiting time for appointments, Halliday said, enabling the department to claim that 95 percent of first-time patients received an evaluation within 14 days when, in reality, fewer than half were seen in that time. Nicholas Tolentino, a former mental-health administrative officer at the VA Medical Center in Manchester, N.H., told the committee that managers pressed the staff to see as many veterans as possible while providing the most minimal services possible. "Ultimately, I could not continue to work at a facility where the well-being of our patients seemed secondary to making the numbers look good," he said.

Although falsifying wait times has been known for years, there has been inadequate action to correct the practice according to the VA OIG. Sen. Murray said the findings show a "rampant gaming of the system." (13). This should not be surprising. Clerical personnel who file the data have their evaluations, and in many cases pay, determined by supervisors who financially benefit from a report of shorter wait times. There appears no apparent penalty for filing falsified data. If penalties did exist, it seems likely that the clerks or clinicians would be the ones to shoulder the blame.

The Current System is Ineffective

A repeated pattern of the OIG being called to look at wait times, stating they are false, making recommendations, the VA concurring, and nothing being done has been going on for years (1, 3-7). Based on these previous experiences, the VA will likely be unable to hire the numbers of clinicians needed and wait times will continue to be unacceptably long but will be “gamed” to “make the numbers look good”. Pressure will be placed on the remaining clinicians to do more with less. Some will become frustrated and leave the VA. The administrators will continue to receive bonuses for inaccurate short wait times. If past events hold true, in 2-5 years another VA OIG report will be requested. It will restate that the VA falsified the wait times. This will be followed by a brief outcry, but nothing will be done.

The VA OIG apparently has no real power and the VA administrators have no real oversight. The VA OIG continues to make recommendations regarding additional administrative oversight which smacks of putting the fox in charge of the hen house. Furthermore, the ever increasing numbers of administrators likely rob the clinical resources necessary to care for the patients. Decreased clinical expenses have been shown to increase standardized mortality rates, in other words, hiring more administrators at the expense of clinicians likely contributes to excess deaths (14). Although this might seem obvious, when the decrease of physicians and nurses in the VA began in the mid 1990’s there seemed little questioning that the reduction was an “improvement” in care.

Traditional measures such as mortality, morbidity, etc. are slow to change and difficult to measure. In order to demonstrate an “improvement” in care what was done was to replace outcome measures with process measures. Process measures assess the frequency that an intervention is performed.  The problem appears that poor process measures were chosen. The measures included many ineffective measures such as vaccination with the 23 polyvalent pneumococcal vaccine in adult patients and discharge instructions including advice to quit smoking at hospital discharge (15). Many were based on opinion or poorly done trials, and when closely examined, were not associated with better outcomes. Most of the “improvement” appeared to occur in performance of these ineffective measures. However, these measures appeared to be quite popular with the administrators who were paid bonuses for their performance.

Root Causes of the Problems

The root causes go back to Kizer’s Prescription for Change. The VA decreased the numbers of clinicians, but especially specialists, while increasing the numbers of administrators and patients. The result has been what we observe now. Specialists such as psychiatrists are in short supply. They were often replaced by a cadre of physician extenders more intent on satisfying a checklist of ineffective process measures rather than providing real help to the patient. Waiting times lengthened and the administrative solution was cover up the problem by lying about the data.

VA medical centers are now usually run by administrators with no real medical experience. From the director down through their administrative chain of command, many are insufficiently medically trained to supervise a medical center. These administrators could not be expected to make good administrative decisions especially when clinicians have no meaningful input (10).

The present system is not transparent. My colleagues and I had to go through a FOIA request to obtain data on the numbers of physicians and nurses presented above. Even when data is known, the integrity of the data may be called into question as illustrated by the data with the wait times. 

The falsification of the wait times illustrates the lack of effective oversight. VA administration appears to be the problem and hiring more administrators who report to the same administrators will not solve the problem as suggested by the VA OIG (3-7). What is needed is a system where problems such as alteration of wait times can be identified on the local level and quickly corrected.

Solutions to the Problems

The first and most important solution is to provide meaningful oversight by at the local level by someone knowledgeable in healthcare. Currently, no system is in place to assure that administrators are accountable.  Despite concurring with the multitude of VA OIG’s recommendations, VA central office and the Veterans Integrated Service Networks have not been effective at correcting the problem of falsified data. In fact, their bonuses also depend on the data looking good. Locally, there exists a system of patient advocates and compliance officers but they report to the same administrators that they should be overseeing. The present system is not working. Therefore, I propose a new solution, the concept of the physician ombudsman. The ombudsman would be answerable to the VA OIG’s office. The various compliance officers, patient advocates, etc. should be reassigned to work for the ombudsman and not for the very people that they should be scrutinizing.

The physician ombudsman should be a part-time clinician, say 20% at a minimum. The latter is important in maintaining local clinical knowledge and identifying falsified clinical data. One of the faults of the present VA OIG system is that when they look at a complaint, they seem to have difficulty in identifying the source of the problem (16). Local knowledge would likely help and clinical experience would be invaluable. For example, it would be hard to say waiting times are short when the clinician ombudsman has difficulty referring a patient to a specialist at the VA or even booking a new or returning patient into their own clinic.

The overseeing ombudsman needs to have real oversight power, otherwise we have a repeat of the present system where problems are identified but nothing is done. Administrators should be privileged similar to clinicians. Administrators should undergo credentialing and review. This should be done by the physician ombudsman’s office.  Furthermore, the physician ombudsman should have the capacity to suspend administrative privileges and decisions that are potentially dangerous. For example, cutting the nursing staffing to dangerous levels in order to balance a budget might be an example of a situation where an ombudsman could rescind the action.

The paying of administrative bonuses for clinical work done by clinicians should stop. Administrators do not have the necessary medical training to supervise clinicians, and furthermore, do nothing to improve efficiency or clinically benefit Veterans (14). The present system only encourages further expansion of an already bloated administration (17). Administrators hire more administrators to reduce their workload. However, since they now supervise more people, they argue for an increase in pay. If a bonus must be paid, why not pay for something over which the administrators have real control, such as administrative efficiency (18). Perhaps this will stop the spiraling administrative costs that have been occurring in healthcare (17).

These suggestions are only some of the steps that could be taken to improve the chronic falsification of data by administrators with a financial conflict of interest. The present system appears to be ineffective and unlikely to change in the absence of action outside the VA. Otherwise, the repeating cycle of the OIG being called to look at wait times, noting that they are gamed, and nothing being done will continue.

Richard A. Robbins, M.D.*

Editor, Southwest Journal of Pulmonary

            and Critical Care

References

1. http://www.va.gov/oig/pubs/VAOIG-12-00900-168.pdf  (accessed 4-26-12).
2. http://www.va.gov/opa/pressrel/pressrelease.cfm?id=2302 (accessed 4-26-12).
3. http://www.ca9.uscourts.gov/datastore/opinions/2011/07/12/08-16728.pdf (accessed 4-26-12).
4. http://www.va.gov/oig/52/reports/2003/VAOIG-02-02129-95.pdf (accessed 4-26-12).
5. http://www.va.gov/oig/54/reports/VAOIG-05-03028-145.pdf (accessed 4-26-12).
6. http://www.va.gov/oig/54/reports/VAOIG-05-03028-145.pdf (accessed 4-26-12).
7. http://www.va.gov/oig/52/reports/2007/VAOIG-07-00616-199.pdf (accessed 4-26-12).
8. www.va.gov/HEALTHPOLICYPLANNING/rxweb.pdf (accessed 4-26-12).
9. http://veterans.house.gov/107th-congress-hearing-archives (accessed 3/18/2012).
10. Robbins RA. Profiles in medical courage: of mice, maggots and Steve Klotz. Southwest J Pulm Crit Care 2012;4:71-7.
11. Robbins RA. Unpublished observations obtained from the Department of Veterans Affairs by FOIA request.
12. http://www.medscape.com/features/slideshow/compensation/2012/psychiatry (accessed 4-26-12).
13. http://seattletimes.nwsource.com/html/localnews/2018071724_mentalhealth26.html (accessed 4-26-12).
14. Robbins RA, Gerkin R, Singarajah CU. Correlation between patient outcomes and clinical costs in the VA healthcare system. Southwest J Pulm Crit Care 2012;4:94-100.
15. Robbins RA, Klotz SA. Quality of care in U.S. hospitals. N Engl J Med 2005;353:1860-1 [letter].
16. Robbins RA. Mismanagement at the VA: where's the problem? Southwest J Pulm Crit Care 2011;3:151-3.
17. Woolhandler S, Campbell T, Himmelstein DU. Health care administration in the United States and Canada: micromanagement, macro costs. Int J Health Serv 2004;34:65-78.
18. Gao J, Moran E, Almenoff PL, Render ML, Campbell J, Jha AK. Variations in efficiency and the relationship to quality of care in the Veterans health system. Health Aff (Millwood) 2011;30:655-63.

*The author is a former VA physician who retired July 2, 2011 after 31 years.

The opinions expressed in this editorial are the opinions of the author and not necessarily the opinions of the Southwest Journal of Pulmonary and Critical Care or the Arizona Thoracic Society.

Reference as: Robbins RA. VA administrators gaming the system. Southwest J Pulm Crit Care 2012;4:149-54. (Click here for a PDF version of the editorial)

Will Fewer Tests Improve Healthcare or Profits?

Earlier this month, the American Board of Internal Medicine (ABIM) Foundation, in partnership with Consumer Reports, announced an educational initiative called Choosing Wisely (1). Nine medical organizations were asked to name five things physicians and patients should question. The initiative lists specific, evidence-based recommendations physicians and patients should discuss to make wise decisions on their individual situation. The list of tests and procedures Choosing Wisely advises against include common procedures and treatments such as EKGs done routinely during a physical examination, routine MRI’s for back pain, antibiotics for mild sinusitis, and routine EKG and chest X-rays preoperatively. Some experts estimate that up to one-third of the $2 trillion of annual health care costs in the United States each year is spent on unnecessary hospitalizations and tests, unproven treatments, ineffective new drugs and medical devices, and futile care at the end of life (2). We at the Southwest Journal of Pulmonary and Critical Care (SWJPCC) applaud the use of evidence-based medicine in determining testing and treatment. Any information that can inform medical decision making is welcome.

With most of the Choosing Wisely recommendations there is solid evidence that the procedures do not improve patient outcomes (1). Nevertheless several previous efforts to limit testing have failed and even provoked backlashes. For example, in November 2009, new mammography guidelines issued by the U.S. Preventive Services Task Force advised women to be screened less frequently for breast cancer, stoking fear among patients about increasing government control over personal health care decisions and the rationing of treatment (2). An area of further concern is that the Choosing Wisely recommendations will be used not just to make informed decisions, but by payers to limit decisions that a patient and physician can make. This is especially true since the motivation for these recommendations may not be to improve care but to decrease expenses and increase profits by insurers and other payers.

Several of the quality improvement and training organizations affiliated with the ABIM have recommendations and guidelines that are either non- or weakly-evidence based and have not been shown to improve patient outcomes. Surely, these should also be questioned. These include most of the hospital performance measures for acute myocardial infarction, congestive heart failure, pneumonia and surgical process of care, the ventilator-associated pneumonia guidelines, and the central line associated bloodstream infection guidelines (3-5).  Furthermore, in examining the requirements for recertification by the ABIM, the parent organization that sponsored the Choosing Wisely initiative, the evidence basis for the ever increasing frequency of examinations for ever increasing fees and the quality improvement initiative in individual practices is unclear (6).

The recommendations number only 5 from each society (with several overlapping) and come from only 9 of the over 50 medical societies, organizations and boards affiliated with the ABIM. Why recommendations from other medical societies including pulmonary and critical care organizations such as the American Thoracic Society (ATS)* and the American College of Chest Physicians (ACCP) were not included was not stated. In order to help the ABIM, ATS and ACCP, we list some procedures and treatments below that pulmonary and critical care physicians might consider for inclusion in the Choosing Wisely recommendations:

1. Pneumococcal vaccination with the 23 polyvalent vaccine in adults
2. Chest X-ray after bronchoscopy or needle biopsy in the absence of symptoms
3. Routine use of heparin for deep venous thrombosis prophylaxis 
4. Routine chest X-ray in the absence of clinical suspicion of intrathoracic pathology
5. Pulmonary consultation for bronchoscopy for nonobstructive atelectasis
6. Ordering blood troponin levels in the absence of a clinical suspicion of myocardial infarction
7. Admission of a patient to the ICU who has chosen not to be resuscitated (DNR) and without clear goals of what is be accomplished in the ICU
8. Provision of powered mobility devices where there is not a clear medical necessity. 
9. Diagnosis and management of  COPD without spirometry
10. Developing and calling guidelines “evidence-based” when they are opinion or developed from nonrandomized trials.

Overall, the Choosing Wisely recommendations are a welcome start provided they are put to the use intended by the ABIM and contributing organizations. These should be expanded by contributions from other specialty groups and societies, but only if the evidence basis for each recommendation is clearly stated and based on adequate trials. Efforts to use these recommendations to control physician practice by proxy for financial gain are unethical and should be prominently noted and publicized if found to occur.

Richard A. Robbins, MD

Allen R. Thomas, MD

References

1. http://choosingwisely.org/?page_id=13
2. http://www.nytimes.com/2012/04/04/health/doctor-panels-urge-fewer-routine-tests.html?_r=1&permid=67
3. Robbins RA, Gerkin R, Singarajah CU. Relationship between the Veterans Healthcare Administration hospital performance measures and outcomes. Southwest J Pulm Crit Care 2011;3:92-133.
4. Padrnos L, Bui T, Pattee JJ, Whitmore EJ, Iqbal M, Lee S, Singarajah CU, Robbins RA. Analysis of overall level of evidence behind the Institute of Healthcare Improvement ventilator-associated pneumonia guidelines. Southwest J Pulm Crit Care 2011;3:40-8.
5. Hurley J, Garciaorr R, Leudy H et al. Correlation of compliance with central line associated blood stream infection guidelines and outcomes: a review of the evidence. (Submitted)
6. http://www.abim.org/research/seminal-bibliography/certification.aspx

*The Southwest Journal of Pulmonary and Critical Care is the official publication of the Arizona Thoracic Society which is the Arizona state affiliate of the  American Thoracic Society.

The opinions expressed in this editorial are the opinions of the authors and not necessarily the opinions of the Southwest Journal of Pulmonary and Critical Care or the Arizona Thoracic Society.

Reference as: Robbins RA, Thomas AR. Will fewer tests improve healthcare or profits? Southwest J Pulm Crit Care 2012;4:111-3. (Click here for a PDF version of the editorial)

Identification of a Biomarker of Sleep Deficiency—Are We Tilting Windmills?

The amount of time spent asleep by adults in the United States and other developing countries is decreasing. It is estimated that over 40 years ago, adults slept in excess of 8 hours per night, but now sleep barely 7 hours per night (1) During this time frame, there has been a corresponding increase in obesity and diabetes mellitus which in part has been attributed to a reduction in time sleeping (2). In addition, sleep deficiency and other sleep disorders have been implicated as risk factors for hypertension, cardiovascular disease and cancer (3-5). Consequently, billions of excess health care dollars are spent on medical conditions associated with sleep deficiency or sleep disorders (6,7). Their impact also include substantial costs resulting from lost productivity as well as increased absenteeism, presenteeism and motor vehicle or industrial accidents (6,7).  Thus, sleep disorders and sleep deficiency are significant threats to public health and productivity in the United States and worldwide and no evidence of a decline is on the horizon. One barrier to reducing their impact is the difficulty in identifying on a societal and personal level the major consequence of sleep deficiency, sleepiness.

Despite the extraordinary progress made by sleep and circadian science in recent years, developing an accurate and easy to use biomarker for sleepiness and/or sleep deficiency has been elusive. Currently used objective assessments of sleepiness such as the multiple sleep latency test or the psychomotor vigilance test are either difficult to use outside the laboratory environment or do not evaluate all domains of sleep deficiency. Subjective assessments of sleepiness are unreliable because many individuals cannot recognize their impairment (8) and in some occupational scenarios (e.g., truck drivers, railroad engineers); there is personal incentive to deny its presence because of the fear of losing employment or income (9).

If developed, there would be several uses for a sleepiness or sleep deficiency biomarker. These include:

• Research: especially in field studies of the impact of sleep deficiency and/or sleepiness in both small and large size cohorts;
• Fitness for duty: in clinical and occupational settings (e.g., operating a motor vehicle, aircraft pilot) where objective assessment of sleepiness would be important in determining whether an individual could perform their job;
• Personal health: such testing might ultimately provide a means for an individual to determine his/her level of sleepiness and allow self adjustment of medication or positive airway pressure in the case of obstructive sleep apnea patients, analogous to currently used home glucose testing in persons with diabetes mellitus;
• Disease risk stratification: level of sleep deficiency might identify individuals with a greater likelihood of developing other medical conditions such as cardiovascular disease or diabetes.

In an attempt to “jumpstart” interest and research into developing a sleepiness or sleep deficiency biomarker, the Division of Sleep Medicine at Harvard Medical School hosted a conference on September 21-22, 2010 supported by the National Heart, Lung and Blood Institute and commercial entities entitled “Finding a Research Path for the Identification of Biomarkers of Sleepiness” (10). A number of prominent national and international speakers presented possible approaches to achieving this goal including behavioral, physiologic, genomic and proteomic solutions. This conference was followed by a panel discussion on this same topic at the annual Sleep 2011 international conference. Despite these high profile public discourses, there has been little progress in finding a sleepiness/sleep deficiency biomarker. A brief search of PubMed identified only one paper published since the conference directly relevant to this area (11).

Why has there been so little progress? I would propose the major reason is lack of a public “outcry”. Despite high profile incidences such as the crash of Colgan Air Flight #3407 (12) and the grounding of the Exxon Valdez (13), and a report from the Institute of Medicine (6) the general public has not adopted sleep issues as a major public health concern. In contrast, cancer, heart disease, obesity and diabetes, all of which may in part be consequences of sleep deficiency or a sleep disorder, are higher in the public consciousness. As a result, it is unlikely that funding initiatives such as a RFA on research into sleepiness or sleep deficiency biomarkers from the National Institutes of Health will be forthcoming.

What can be done? It should be the mission of all of us who are involved in sleep research and clinical Sleep Medicine to promote to the public the importance of sleep deficiency and sleep disorders in adversely impacting public health. Until there is a ground swell of public support, I fear attempts to identify biomarkers for sleepiness or sleep deficiency may be similar to “tilting at windmills.”

Stuart F. Quan, M.D.

Division of Sleep Medicine,

Brigham and Women’s Hospital and Harvard Medical School

401 Park Dr., 2^nd Floor East

Boston, MA 02215

Voice: 617-998-8842

Fax: 617-998-8823

Email: Stuart_Quan@hms.harvard.edu

References

1. McAllister EJ, Dhurandhar NV, Keith SW, et al. Ten putative contributors to the obesity epidemic. Crit Rev Food Sci Nutr 2009;49:868-913.
2. Spiegel K, Tasali E, Leproult R, Van Cauter E. Effects of poor and short sleep on glucose metabolism and obesity risk. Nat Rev Endocrinol 2009;5:253-261.
3. Budhiraja R, Sharief I, Quan SF. Sleep disordered breathing and hypertension. J Clin Sleep Med 2005; 1:401-4.
4. Kakizaki M, Kuriyama S, Sone T, et al. Sleep duration and the risk of breast cancer: the Ohsaki Cohort Study. Br J Cancer 2008; 99:1502-5.
5. Quan SF. Sleep Disturbances and their Relationship to Cardiovascular Disease. Am J Lifestyle Med 2009; 3:55s-59s.
6. Colten HR, Altevogt BM, Institute of Medicine. Committee on Sleep Medicine and Research. Sleep disorders and sleep deprivation: an unmet public health problem. Washington, DC: Institute of Medicine: National Academies Press, 2006; 404.
7. Anonymous. The Price of Fatigue: the surprising economic costs of unmanaged sleep apnea. 2010. https://sleep.med.harvard.edu/what-we-do/public-policy-research
8. Durmer JS, Dinges DF. Neurocognitive consequences of sleep deprivation. Semin Neurol 2005;25:117-129.
9. Smith B, Phillips BA. Truckers drive their own assessment for obstructive sleep apnea: a collaborative approach to online self-assessment for obstructive sleep apnea. J Clin Sleep Med 2011;7:241-245.
10. Anonymous. Harvard Biomarkers of Sleepiness Conference. 2011. https://sleep.med.harvard.edu/what-we-do/biomarkers-conference
11. Goel N, Banks S, Lin L, Mignot E, Dinges DF. Catechol-O-methyltransferase Val158Met polymorphism associates with individual differences in sleep physiologic responses to chronic sleep loss. PLoS One 2011;6:e29283.
12. Anonymous. Colgan Air Flight 3407. 2012. http://en.wikipedia.org/wiki/Colgan_Air_Flight_3407#cite_note-ntsb.2Faar-10.2F01-20
13. Anonymous. Details about the Accident SPILL: The wreck of the Exxon Valdez Final Report, Alaska Oil Spill Commission. 1990. http://www.evostc.state.ak.us/facts/details.cfm

Reference as: Quan SF. Identification of a biomarker of sleep deficiency-Are we tilting windmills? Southwest J Pulm Crit Care 2012;4:58-60. (Click here for a PDF version of the editorial) 

Competition or Cooperation?

One of our local institutions, the Mayo Clinic Arizona, was mentioned in a recent op-ed in the New York Times. The editorial entitled, “It Costs More, but Is It Worth More?” by Ezekiel J. Emanuel and Steven D. Pearson (1), criticizes the Mayo Clinic in Rochester and Arizona for building two new proton beam treatment facilities at a cost of more than $180 million dollars each.  It accuses the Mayo Clinic of participating in “…a medical arms race for proton beam machines, which could cost taxpayers billions of dollars for a treatment that, in many cases, appears to be no better than cheaper alternatives”. The editorial states that except for a handful of rare pediatric cancers, the evidence is lacking for treatment of other types of cancer such as lung, esophageal, breast, head and neck, and prostate cancers.

John Noseworthy MD, President and Chief Executive of the Mayo Clinic, replied that the Mayo Clinic “will carefully study proton therapy and other new therapies, compare clinical outcomes and offer high-quality, cost-effective, proven and safer treatments for patients”. In another letter to the Minneapolis StarTribune, Nosewothy goes on to say, “Mayo Clinic takes serious issue with the authors' use of Mayo Clinic and its programs in this manner. As a not-for-profit institution, we are motivated by the best interests of our patients, not ‘profit’ or competitiveness. With the facility costs, start-up expenses and the extensive training required to offer this therapy, we do not expect to break even, much less earn a ‘profit,’ on our proton therapy program for years”.

I am not an expert in either cancer treatment or proton beam therapy, but a weekend search of the medical literature largely confirms that the therapy is unproven for most cancers, although there was no evidence that proton beam is inferior to more traditional means of delivering radiation therapy. Second, the cost of proton beam therapy is high. Costs are about $55,000 plus $15,000 in physician fees per patient for the therapy alone, twice as much as a linear accelerator. This sounds like a lot of money but you still need an estimated volume of about 2,000-3,500 patients per year to cover an investment of over $180 million investment.

So why are the Mayo Clinic and others constructing these centers since they are expensive; mostly of unproven superiority over existing therapies; and reimbursement, although generous, may not cover the cost of the facility? The answer is likely competition. Competition for patients largely drives tertiary referral centers. Locally, there is a small war going on between the Mayo Clinic Arizona and the new Banner MD Anderson Cancer Center. Mayo Clinic is concerned about MD Anderson having greater name recognition and losing its patients to the new center. Banner in partnership with MD Anderson sees an opportunity to compete in a large metropolitan center without a strong university medical center. Mayo Clinic Arizona undoubtedly feels that new technologies such as proton beam are necessary to compete with MD Anderson, especially since MD Anderson has a proton beam therapy unit in Houston.  

All this is probably not good for patients and illustrates that competition in medicine does not necessarily lead to cheaper, more effective care. Patients will be easily persuaded to receive the latest and greatest therapy when their life is on the line, especially when the bulk of the cost is covered by a third party. Whether proton beam therapy is the latest and greatest is fairly difficult to determine at this time, given the absence of well designed, randomized studies. The Center for Medicare and Medicaid Services (CMS) process of determining reimbursement costs is largely a mystery but needs to show some restraint. Large reimbursements for unproven therapies such as proton beam while underfunding areas with well demonstrated benefits is not in the best public interest. Furthermore, instead of directly or indirectly encouraging competition, CMS needs to foster cooperation. Perhaps requiring hospitals to work together to study the effectiveness of proton beam to get reimbursed would be a good first step. As Franklin D. Roosevelt said, “Competition has been shown to be useful up to a certain point and no further, but cooperation, which is the thing we must strive for today, begins where competition leaves off” (5).

Richard A. Robbins, MD

Editor, Southwest Journal of Pulmonary and Critical Care

References

1. Emanuel EJ, Pearson SD. It costs more, but is it worth it? New York Times. http://opinionator.blogs.nytimes.com/tag/proton-beam-therapy/ (accessed 1-23-12).
2. Noseworthy J. Mayo clinic’s investment. New York Times. http://www.nytimes.com/2012/01/06/opinion/mayo-clinics-investment.html (accessed 1-23-12).
3. Nosewothy J.  Mayo CEO defends use of proton beam therapy. Minneapolis StarTribune http://www.startribune.com/opinion/otherviews/136758278.html (accessed 1-23-12).
4. Clark C. What would super committee say about $430m proton beam center war? http://www.healthleadersmedia.com/page-1/QUA-272912/What-Would-Super-Committee-Say-About-430M-Proton-Beam-Center-War (accessed 1-23-12).
5. http://www.brainyquote.com/quotes/authors/f/franklin_d_roosevelt.html (accessed 1-23-12).

Reference as: Robbins RA. Competition or cooperation? Southwest J Pulm Crit Care 2012;4:30-1. (Click here for a PDF version of the editorial)