Breaking the Guidelines for Better Care

Two events happened this past week that inspired this editorial. First, on Wednesday morning I read the editorial titled “Breaking the Rules for Better Care” by Don Berwick et al. in JAMA (1). Berwick reports a survey of about 40 hospitals done by The Institute of Healthcare Improvement (IHI). The survey asked the question “If you could break or change any rule in service of a better care experience for patients or staff, what would it be?”. The answers were not surprising. Most centered on annoying hospital rules such as visiting hours, not waking patients, correct HIPPA interpretation, and eliminating the 3-day rule. Although these are correct, in the whole they have minimal effect on healthcare. Other suggestions more likely to improve patient care included improving access, reducing wait times and earlier patient mobility. From the suggestions, it seems likely that most were from administrators. In the editorial Berwick decried, “Habits embedded in organizational behaviors, based on misinterpretations and with little to no actual foundation in legal, regulatory, or administrative requirements”. He goes on to say, “Health care leaders may be well advised to ask their clinicians, staffs, and patients which habits and rules appear to be harming care without commensurate benefits and, with prudence and circumspection, to change them.” As a clinician, I thoroughly agree with both of Berwick’s points.

Later that afternoon, I listened to a lecture by Clement Singarajah on sepsis guidelines. He reviewed the severe sepsis bundles promoted by the Surviving Sepsis Campaign and IHI, the latter being Berwick’s organization who wrote the editorial noted above (Table 1) (2,3).

Table 1.  Severe Sepsis Bundles.

The Severe Sepsis 3-Hour Resuscitation Bundle contains the following elements, to be completed within 3 hours of the time of presentation with severe sepsis:

• Measure Lactate Level
• Obtain Blood Cultures Prior to Administration of Antibiotics
• Administer Broad Spectrum Antibiotics
• Administer 30 mL/kg Crystalloid for Hypotension or Lactate ≥4 mmol/L

The 6-Hour Septic Shock Bundle contains the following elements, to be completed within 6 hours of the time of presentation with severe sepsis:

• Apply Vasopressors (for Hypotension That Does Not Respond to Initial Fluid Resuscitation to Maintain a Mean Arterial Pressure (MAP) ≥65 mm Hg)
• In the Event of Persistent Arterial Hypotension Despite Volume Resuscitation (Septic Shock) or Initial Lactate ≥4 mmol/L (36 mg/dL):
  • Measure Central Venous Pressure (CVP)
  • Measure Central Venous Oxygen Saturation (ScvO2)
• Remeasure Lactate If Initial Lactate Was Elevated

We carefully reviewed each of the metrics, and concluded most were non-evidence based, outdated, or contradicted by more recent and better trials. The only exception was early antibiotic administration. Most of us reaffirmed our belief in the germ theory and felt that early administration of the correct antibiotics was probably mostly evidence-based and reasonable (4).

Is it possible that most of the metrics in the bundle are merely a waste of time as we concluded or could some be harmful? First, a recent meta-analysis examined a conservative fluid strategy in sepsis compared with a liberal strategy (the goal-directed therapy as advocated by the sepsis bundles) (5). Although there was no change in mortality, a conservative strategy resulted in increased ventilator-free days and reduced length of ICU stay. The meta-analysis concluded that the studies were underpowered to show a mortality benefit. Second, most of us had experienced delays in initiating antibiotics, the only guideline that makes a difference, while waiting for blood cultures to be drawn. None of us knew data that drawing blood cultures makes a difference in patient outcomes.

Berwick recommended asking clinicians which rules may be harming care. Rather than chiding others to do something, a good place to start might be IHI’s sepsis guidelines. The issue of continued support for non-evidence based or outdated guidelines points out the rigid dichotomy between self-delusional beliefs and science. Many (some would say most) guidelines are based on opinions and not science (6). Healthcare would be better if groups such as the Surviving Sepsis Campaign, IHI and the Centers for Medicare and Medicaid Services would follow their own advice and not burden healthcare providers with non-evidence based guidelines. Instead, they should only issue guidelines after carefully conducted, randomized, controlled trials establish a guideline rather than mandating the self-delusional beliefs of a few.

Richard A. Robbins, MD

Editor, SWJPCC

References

1. Berwick DM, Loehrer S, Gunther-Murphy C. Breaking the rules for better care. JAMA. 2017 Jun 6;317(21):2161-2. [CrossRef] [PubMed]
2. Surviving Sepsis Campaign. Updated bundles in response to new evidence. Available at: http://www.survivingsepsis.org/SiteCollectionDocuments/SSC_Bundle.pdf (accessed 6/9/17).
3. Institute for Healthcare Improvement. Severe sepsis bundles. Available at: http://www.ihi.org/resources/Pages/Tools/SevereSepsisBundles.aspx (accessed 6/9/17).
4. Seymour CW, Gesten F, Prescott HC, et al. Time to treatment and mortality during mandated emergency care for sepsis. N Engl J Med. 2017 Jun 8;376(23):2235-44. [CrossRef] [PubMed]
5. Silversides JA, Major E, Ferguson AJ, et al. Conservative fluid management or deresuscitation for patients with sepsis or acute respiratory distress syndrome following the resuscitation phase of critical illness: a systematic review and meta-analysis. Intensive Care Med. 2017 Feb;43(2):155-170. [CrossRef] [PubMed]
6. Lee DH, Vielemeyer O. Analysis of overall level of evidence behind Infectious Diseases Society of America practice guidelines. Arch Intern Med. 2011;171:18-22. [CrossRef] [PubMed]

Cite as: Robbins RA. Breaking the guidelines for better care. Southwest J Pulm Crit Care. 2017;14(6):285-7. doi: https://doi.org/10.13175/swjpcc072-17 PDF 

IOM Releases Report on Graduate Medical Education

On July 29 the Institute of Medicine (IOM) released a report on graduate medical education (GME) (1). This is the residency training that doctors complete after finishing medical school. This training is funded by about $15 billion annually from the Federal government with most of the monies coming from the Center for Medicare and Medicaid Services (CMS). The report calls for an end to providing the money directly to the teaching hospitals and to dramatically alter the way the funds are paid. Instead payments would be made to community clinics phased in over about 10 years. To administer the program, the report recommends the formation of two committees: 1. A GME Policy Council in the Office of the Secretary of the U.S. Department of Health; and 2. A GME Center within the Centers for Medicare & Medicaid Services to manage the operational aspects of GME CMS funding. The later committee would administer two funds: 1. A GME Operational Fund to distribute ongoing support for residency training positions that are currently approved and funded; and 2. A GME Transformation Fund to finance initiatives to develop and evaluate innovative GME programs, to determine and validate appropriate GME performance measures, to pilot alternative GME payment methods, and to award new Medicare-funded GME training positions in priority disciplines and geographic areas.

If adopted, the plan would end decades of attempts by CMS to coerce medical school graduates into primary care, especially in rural, underserved areas. By controlling funding for GME training, CMS would be able to dictate how physician training. Negative reaction was expected and swift from the American Hospital Association, the American Medical Association and the American Council on Graduate Medical Education, whose members would lose CMS money (2-4). Also expected, the proposal was supported by the American Academy of Family Physicians whose members who would gain under the proposal (5).

The IOM committee has a point. Despite a growing public investment in GME, there are persistent problems with uneven geographic distribution of physicians, too many specialists, not enough primary care providers, and a lack of cultural diversity in the physician workforce. Furthermore, according to the report "a variety of surveys indicate that recently trained physicians in some specialties cannot perform simple procedures often required in office-based practice.”

However, can a committee formed by CMS be expected to improve the health of America? Based on the composition of the committee and their past performance we think not. First, the committee was co-chaired by Don Berwick who was head of the Institute for Healthcare Improvement (IHI), CMS Administrator and presently a candidate for Massachusetts governor (6). During Berwick's tenure, the IHI proposed a number of non- or weakly evidence-based metrics. Many of these have been found to make no impact on patient-centered outcomes such as mortality, length of stay, readmission rates, morbidity, etc. (7). An example was the 18 month 100,000 Lives Campaign which according to Berwick prevented 122,300 avoidable deaths. However, the methodology, incomplete data and sloppy estimation of the number of deaths makes Berwick's claim dubious. Furthermore, when the campaign was expanded to the 5,000,000 Lives Campaign the "results" could not be reproduced. Also during Berwick's tenure, IHI prematurely championed tight control of blood sugar in the ICU, an intervention which resulted in a 14% increase in ICU mortality when properly studied (8). Undaunted, Berwick put many of these same meaningless metrics in place when he became administrator of CMS. One of these metrics, readmission rates, has been associated with a higher mortality (9). Now Berwick is running for Massachusetts governor. One wonders how politics might have affected the report.

Other members of the committee include the committee co-chair, Gail Wilensky, who was administrator of HCFA (the precursor of CMS), nurses, physician assistants, economists, a representative from industry and a number of academics. Missing were members of the large community of practicing physicians. It seems the IOM committee was assembled to produce a political rather than an evidence-based answer of how to solve patient care disparities. To paraphrase a well-known quote, the first casualty of politics is usually the truth. It seems likely that the proposed GME Center within CMS would have a similar composition to Berwick's present IOM committee and would likely offer political rhetoric rather than meaningful reform to GME. Similarly to those championed by Berwick at IHI and later CMS, we suspect that a series of meaningless metrics would be required that would do nothing other than add a paper burden to a medical system already drowning in paperwork. By removing local control, CMS will likely ignore local strengths. For example, the University of Colorado has an extremely strong pulmonary and critical care division. Although America needs this physician expertise, especially critical care, it seems likely that CMS might move these residency slots to family practice or general medicine. We believe that local control with appropriate incentives, is more likely to solve these problems than a centralized bureaucracy in Washington.

Lastly, a word about the report's claim graduates lack the skills to perform basic procedures. Our observations are similar and we are inclined to accept the claim. However, we point out that it was decisions of committees such as those proposed that required attending physicians to perform procedures in order to be reimbursed and that residents have fewer opportunities to perform procedures due to work hour restrictions. The committee's implication that somehow physician trainers are to blame seems quite disingenuous. Not identified in the report but crucial to physician development is developing skills to critically evaluate medical literature, rather than blindly follow the guidelines proposed by CMS, IHI or others of a similar ilk. 

The proposals in the IOM report are a bad idea from a committee whose head has been rife with bad ideas. The committee's report is not the "New Flexner Report" but will be the coffin nail in the death of quality, caring physicians if adopted.

Richard A. Robbins, MD

Clement U. Singarajah, MD

Phoenix Pulmonary and Critical Care Research and Education Foundation

Gilbert, AZ

References

1. Institute of Medicine. Graduate medical education that meets the nation's health needs. July 29, 2014. Available at: http://www.iom.edu/Reports/2014/Graduate-Medical-Education-That-Meets-the-Nations-Health-Needs.aspx (accessed 8/5/14).
2. American Hospital Association. IOM panel recommends new financing system for physician training. July 29, 2014. Available at: http://www.ahanews.com/ahanews/jsp/display.jsp?dcrpath=AHANEWS/AHANewsNowArticle/data/ann_072914_IOM&domain=AHANEWS (accessed 8/5/14).
3. Hoven AD. AMA urges continued support for adequate graduate medical education funding to meet future physician workforce needs. July 29, 2014. Available at: http://www.ama-assn.org/ama/pub/news/news/2014/2014-07-29-support-graduate-medical-education-funding.page (accessed 8/5/14).
4. Kirch DG. IOM’s vision of GME will not meet real-world patient needs. July 29, 2014. Available at: https://www.aamc.org/newsroom/newsreleases/381882/07292014.html (accessed 8/5/14).
5. Blackwelder R. Recommended GME overhaul will support a physician workforce to meet nation’s evolving health needs. July 29, 2014. Available at: http://www.aafp.org/media-center/releases-statements/all/2014/gme-physician-workforce.html (accessed 8/5/14).
6. About Don. Available at: http://www.berwickforgovernor.com/about-don (accessed 8/5/14).
7. Robbins RA. The unfulfilled promise of the quality movement. Southwest J Pulm Crit Care. 2014;8(1):50-63. [CrossRef]
8. NICE-SUGAR Study Investigators. Intensive versus conventional insulin therapy in critically ill patients. N Engl J Med 2009;360:1283-97. [CrossRef] [PubMed]

Reference as: Robbins RA, Singarajah CU. IOM releases report on graduate medical education. Southwest J Pulm Crit Care. 2014;9(2):123-5. doi: http://dx.doi.org/10.13175/swjpcc107-14 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: http://www.swjpcc.com/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: http://www.swjpcc.com/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: http://www.swjpcc.com/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: http://www.swjpcc.com/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