Who worries about physician behavior? Who is ultimately responsible?

There is a true story of a 30 yo woman who has a history of rheumatoid arthritis, and who developed unusual eye symptoms. She went to a physician who referred her to a neurologist (both were “independent medical practitioners”). The neurologist diagnosed Myasthenia Gravis and ordered a CT scan of the thymus. When there was a report of an unusual density in the thymus, a thymectomy was recommended. The patient was told that the alternative therapy was potentially long term corticosteroids. She sought, and received, a second opinion from a nearby Academic Medical Center by a neurologist, specializing in neuromuscular diseases and especially in Myasthenia Gravis. The specialist at the AMC could not confirm the diagnosis of MG. The young woman then went to Mayo clinic, where again the diagnosis of MG was not confirmed and the diagnosis of thymus tumor was also unable to be verified. To date there is no clear diagnosis of this woman’s problem, but neither the diagnosis of Myasthenia Gravis, or of Thymus tumor was confirmed.

Questions:

  1. The AMA has long had a prohibition on disagreements with prior diagnoses by other physicians dating to a 1903 code of ethics. When is it ethical to discuss a disagreement in a diagnosis with a patient?
  2. What is the obligation of a hospital/system, if the surgery was done?
    1. The OR is clean, anesthetic gasses and drugs are appropriately labeled and dispensed.
    2. The Surgeon removes Thymus and there are no complications from the surgery.
    3. The Pathologist (a hospital employee in most instances) reports a non-diseased thymus.
    4. The Patient’s symptoms remain stable.
  3. If we assume A – D then does the hospital have an obligation to question the appropriateness of the therapy in a case like this?
  4. The referring physician and the neurologist believe that they have performed a valuable service to the patient. Did they?
    Is there a mandatory case review of a specific number of cases and what is
    the censure if reviews are not attended?
  5. What is the responsibility of the payer?
    1. The treatment was not for a diagnosis that was confirmed.
    2. There will be follow up visits.
    3. How can we incentivize doctors to make time to “go to the literature” when they don’t know the answer to a patient problem from their experience base?
    4. How can we incentivize doctors to find the person who may be best able to help this patient, without destroying the physician patient relationship?
  6. What is the responsibility of the Medical Society/State Licensing Board?

This was not quite “Malpractice”, but it wasn’t good medical practice. There are probably no “right” answers to most of these questions. They may, however, be a place to start.

I would encourage you, the reader, to comment as you see fit.

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Who is responsible? Is there Enough Accountability in Medicine?

The Alligator Allegory reads:

The objective of all dedicated employees should be:
To thoroughly analyze all situations,
Anticipate all problems prior to their occurrence,
Have answers for these problems,
And
Move swiftly to solve these problems when called upon.

However, when you are up to your ass in alligators, it is difficult to remind yourself that your initial objective was to drain the swamp.”

Steven Spears in “Chasing the Rabbit” makes the point that in high velocity organizations senior staff must exhibit an openness to acknowledging when a system isn’t working and when mistakes are made. We don’t do this at all well in medicine. Hospitals and professional staffs are discouraged from looking for and reporting errors. There are many reasons for these behaviors, which, in the long run, will hinder our attempts to improve quality, safety and efficiency of health care. One of the most quoted hindrances to transparency in looking at errors is the fear of legal reprisal, in the form of “Medical Malpractice” exposure. However, the culture in medicine where the physician and, increasingly, the nurse are expected to “analyze all situations and have solutions to all problems before they arise” makes finding an error an admission of incompetence. Reporting an error may bring a torrent of blame from supervisors or teachers.

“Fix the Problem, not the Blame”, read a plaque above the head of one of the most revered hospital administrators in Chicago. To date, we haven’t been able to internalize that sentiment. There are also time constraints. Almost uniformly when an error is reported, the reporter has to make time to follow up and help with investigation of the incident. What should systems do to try to help undo the “code of silence”? There is no “easy” solution. The legal climate isn’t likely to be changed. However, in many states there is a way around discovery, because minutes of quality improvement committees are not “discoverable”. The Federal Patient Safety and Quality Improvement Act of 2005 – PL 109-41 includes protections in this area. However, some state laws also apply to these activities. AHRQ has a website devoted to Patient Safety Organizations and associated federal regulations..  Institutions or systems can encourage an atmosphere of openness, acknowledge that the system is NOT perfect and reward the reporting of inefficiencies or errors in the system. The enterprise can also authorize people to bring solutions to problems to supervisors, experts, or committees. (What ever happened to the suggestion box? It could even be a virtual suggestion box in the employee portal for most enterprises). Institutions can hold blameless people who do commit an error and acknowledge the error promptly. Clearly this wouldn’t hold for repeated instances of similar errors by the same person.

If organizations don’t develop a culture of real process improvement, we will continue to do the same thing over and over again. Three levers for improvement are:

  1. Acknowledge that errors can and do occur
  2. Authorize staff to look for and report errors
  3. Hold staff blameless when occasional errors are found and reported.

A corollary to this last lever is that staff should be held accountable for repeated errors that are not addressed and corrected.

Solving problems by transparency and openness will only help align staff, physicians and institutions into a more effective system and improve patient outcomes These outcomes would include mortality, readmissions, cost and patient satisfaction.

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Medical Ethics should address more than the individual patient encounter

George Lundberg, reviewed what he called the Principles of medical ethics in his blog on  MedPageToday.com on December 20, 2010. He’s done us a service by bringing this up as the season for reflection is upon us.

The AMA’s Code of Medical ethics as revised in June 2001 is separate from the Hippocratic Oath, which most medical students recite on graduation. The AMA’s Code, which is less widely known, also reads like much of what should be noble in the profession, as it relates to an individual physician-patient encounter.

However, the code is fuzzy when it talks about the patient as paramount. There is nothing in these principles that relates to stewardship of health resources that are not limitless. There are multiple examples where physicians have done what they may have thought were in the patient’s best interest, but actually hurt them. One of the most egregious examples of this was in the 1990s when there was benefit presumed from bone marrow transplant based therapies for women with stage IV breast cancer. Physicians sent women for this therapy believing that it would help prolong their lives. Most often this was based on thinking of the patient as paramount, even if the therapy actually didn’t help most patients who had been studied. Where does the physician’s responsibility for evaluating the mountain of medical literature and for reaching a valid independent conclusion about an individual patient’s likelihood of benefiting from a therapy begin or end. In 2010 there were approximately 4600 journals catalogued in the Medline Database at the National Center for Biotechnology Information (NCBI). What a physician does for an individual patient must clearly be in the best interest of that patient. However, an individual physician’s “clinical judgment” may often be colored by his heuristics and individual biases. We need to work on ways of allowing us to be better informed and generally work in the patient’s as well as society’s best interests. We simply cannot do everything possible for an individual patient without taking into account the incremental benefit of individual diagnostic tests or therapeutic adventures.  There multiple examples of where a “it can’t hurt” to do a diagnostic or therapeutic procedure has led to catastrophic outcomes.

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What is “CE Research/Analysis”? Who should be responsible for it’s implementation?

“CE” in medical parlance stands for either Comparative Effectiveness or Cost Effectiveness analysis. Both types of analyses are intended to allow health care providers (physicians, health systems, physician extenders) and patients reach rational decisions about choices in the treatment of specific clinical conditions. Most of the discussion today is on Comparative Effectiveness analysis, without a specific cost component. Comparative effectiveness analysis is critically important in today’s environment when there are often multiple therapeutic options. In the current practice, a practitioner who is familiar with a single modality is more likely to believe in that technique and will frequently, in good faith, recommend his/her most familiar therapy to most of her/his patients. Two examples come immediately to mind:

  • Treatment of a patient with coronary disease and mild stable angina: –
    a.  An interventional cardiologist is likely to believe that angioplasty, usually with a stent, is optimal
    b.  A cardiac surgeon is likely to recommend CABG, especially if the patient has multi vessel disease
    c.  Finally, the medical cardiologist will recommend pharmacotherapy in conjunction with exercise training in cardiac rehabilitation.

The results of the COURAGE trial, released in 2007, suggest that from the vantage of trying to prevent myocardial infarction or death, the three therapies are equivalent.

  • Treatment of a middle aged man with localized low risk prostate cancer:
    a.  A urologic surgeon has two potential procedures to offer: open or robotically assisted prostatectomy
    b.  A radiation oncologist has external beam radiation (IMRT, proton beam, or others) or implantation of “seeds” in the gland.
    c.  A third option would be watchful waiting.

Again from the vantage point of survival it appears that none of these have a clear advantage (see Watchful Waiting Wins Better Life).

One study identified five hundred potential screening measures for a general population of patients. A busy generalist cannot/should not be expected to be familiar with all potential therapies and come up with his/her reasoned preferences to all clinical conditions that might be seen in any month of practice.

Recognizing that there were few data sets to help with decision-making when competing therapies are present, a Democratic Congress authorized, and Ronald Regan signed, legislation creating and funding the Agency for Health Care Policy & Research. The charge to this agency was to encourage “Health Services Research”. In 1999, a Republican Congress and President Bill Clinton, extended the charge to the agency, but changed the name to the Agency for Healthcare Research and Quality (AHRQ). In 2003, the 108th Congress, with Republican majorities in both houses, and President G. W. Bush, passed the “Medicare Prescription Drug Improvement and Modernization Act” (MMA 11/25/03 PL 108-73), which authorized $50MM on outcomes and clinical effectiveness research (sect 1013). At this time there was a shift in terminology, calling CE research “Patient Centred Outcomes Research” (PCOR). In 2009, as part of the American Recovery & Reinvestment Act, Congress authorized $1.1BB for PCOR, $600MM of which went to directly fund or be administered by AHRQ. Finally, in 2010, as part of the Patient Protection and Affordable Care Act (PPACA, PL 111-148), further funding to PCOR was made into law. Clearly, the history of Comparative Effectiveness research has been non-partisan and supported by Congresses and presidents of both parties.

As currently configured, the goal of PCOR is to encourage thoughtful analysis of various ways of delivering care so that a patient in one part of the country should receive care that is not dissimilar to that from another. It is also intended to help with informed discussion between providers and patients. The PPACA has clear language that the results of CE analysis are not to be used to make guidelines or to limit payment. PCOR results are to be “descriptive not proscriptive”. The results of these analyses are to identify what is known and what is not (shades of Rumsfeld’s – known unknowns and unknown unknowns). There are gaps in what we know about effectiveness as opposed to efficacy, and we need to look at therapies in the light of potential benefits and harms. Many of these data will come from registries (a few of which are already active). While registries don’t have the scientific rigor of a randomized clinical trial, if done well, they can give useful information. Some data should always be better than none. As we get more registry data, our ability to do a better job of data collection will improve.

Why then, is there so much anxiety over government sponsored health systems research while there is almost none over NIH funding for “basic biomedical research”? Many stakeholders may find the reasons in a feeling, that further research is simply not needed. Some people, especially physicians, are afraid that the data will be imperfect and may be misleading. Others are anxious that once the data are available, they will be used to limit payment for some forms of therapies that have been found to be less effective. They believe that even though the current legislation prohibits this, future congresses or executive departments (CMS) may “misuse” the results of the analyses. There is certainly precedent for this feeling. On the other hand, in the absence of CE analysis, some therapies with a large potential for real harm and little return may be used with the best of intentions. Finally, individual providers (health systems and physicians at least) may feel anxiety that something they have invested dollars or training in may be found to be no more effective than another treatment. The more effective treatment may be either less costly or provided by another specialist or institution. Thus, there may be a need for an institution to reconsider use of a facility that has already been built. A physician may need to re-train in another medical field.

It would appear that with both the knowns and the unknowns that exist in medicine in the early 21st century, we should do as much as possible to understand the relative merits of differing therapies. CE research/analysis is clearly one technique to help gain such insight. If the private sector (industry, professional organizations) won’t do it in an unbiased manner, then perhaps an agency such as AHRQ should have our support, counsel and thought.

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What does the Patient Protection and Affordable Care Act (PP ACA; PL 111-148) say about Alignment?

The PP ACA, stored as HR 3590 and signed into law on March 23, 2010, is 906 pages long. Most of the bill consists of amendments to other portions of the Laws of the United States as enumerated in the United States Code (USC). The first 12 pages of the law are the table of contents and the last 141 pages are amendments. This leaves 753 pages of the initial law as proposed. Believe me, the act is not riveting reading. (If you are interested, send me an e-mail or comment and I will forward a copy of the table of contents with page references to the bill referred to above.)  Part III of Title III (from page 271 -297 or 3% of the bill) refers to “Encouraging Development of New Patient Care Models”. One of these models is the Shared Savings Program, which refers to the beginning of the definition of Accountable Care Organizations. Contracts for ACOs are to be initiated by January 2012. ACOs must be responsible for costs of both Part A (Hospital Care) and Part B (Supplementary Medical Insurance Benefits….) which include: Physician Fees, services of Nurse-Midwives, Psychologists, and Nurse Anesthetists as well as Nurse Practitioners or Clinical Nurse Specialists and provision of prosthetics. (There is nothing in this version of the bill on Physician Assistants) The bill also precludes participation in an ACO if the group is also participating in other programs that may include shared savings programs. Such programs may be proposed by the Center for Medicare and Medicaid Innovation, which will also be established under this legislation. These programs leave a great deal of uncertainty as to which model one wants to initially explore.

In the ACO portion of the law there are sets of requirements that ACOs should meet:

(1)  There are 5 groups of requirements for providers who may participate

(2)  There are 8 groups of requirements for financial arrangements including:

a.      A three-year commitment for the ACO to remain in the program.

b.     Minimum provider and patient (beneficiary) numbers

c.     Leadership structure including both administrative and clinical representation

(3)  There is a group of 4 reporting requirements including quality measures

(4)  There is a specific provision that forbids duplication of participation with other SSPs (see above)

The amendment section of the bill also allows the secretary to explore other payment models, including not being responsible for ALL of the components of Part B. In addition the amendments allow ACOs to work with “other third party arrangements”.  In fact, the Secretary may give preference to ACOs that work with both CMS and other payers.

One must also keep in mind that the Secretary of Health and Human Services (currently Mrs. Sebelius) is obligated to explore other models. These include programs to reduce hospital readmissions, an extension of gainsharing initiatives, as well as pilot programs on payment bundling. The latter is also to begin in 2013.

Bundling projects have been around since at least 1996 when the CABG Program involving 7 hospitals resulted in savings to Medicare of approximately $42,000,000 (Almost $73MM in today’s dollars).  At the same time these hospitals had an approximately 20% risk adjusted reduction in mortality while maintaining higher patient satisfaction. The Acute Care Episode Project that is currently underway is also demonstrating savings in some of the hospitals that have contracted with CMS.

Are there opportunities for systems that are better aligned with their medical providers to excel in the era of PP ACA? The above summary of some of the provisions of Title III would suggest that there are many. Those systems that have closely aligned with their physicians or who are now attempting to working with their physicians will have a leg up on others in their geography when it comes to providing services within the parameters of the new law.

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Are We Ready for Change in Our Systems?

Innovation in any field involves change.  Medicine or health care is no exception.  However, not all change involves innovation. With the passage of the Patient Protection and Affordable Care Act (PL 110-148) in March of 2010 there will be change in the way medical care is paid for or purchased, and in the way it is delivered in the acute care facility as well as in the outpatient arena. Payment changes are already underway. CMS has demonstration projects on ways of sharing the cost risk with systems (e.g.: Physicians’ Group Practice and the Acute Care Episode Project) and is rushing to create Accountable Care Organization (ACO) models. The projects that are ongoing or have been finished show that care can be delivered more effectively and efficiently than at present. Patient acceptance of these models of care delivery and patient satisfaction with their care have improved in these projects. As payment models change, systems and physicians will have to work together to be effective in the new marketplace. There will be groups within the stakeholder groups – systems, physicians, ancillary staffs, and patients as well as payers – that will not want to embrace this change. They will be the losers in the “new healthcare” landscape. Change WILL happen. Are we ready to manage this?

It is said that 50-70% of attempts to bring about change in an organization fail.  This need not be an inevitable outcome of a change initiative. If there is no organized change initiative, the likelihood of failure will be great. If the potential disruption that change can bring about is anticipated and systems actively manage the process, then success is more likely.

John Kotter the Professor of leadership and change at Harvard Business School, outlined in HBR (March-April 1995) why change efforts fail. He posits 8 steps to initiating, implementing and maintaining change:

  1. Establish a sense of urgency
  2. Form a Coalition to guide the process
  3. Create a Vision that is understandable by all stakeholders
  4. Communicate the Vision
  5. Empower others to act on the Vision
  6. Plan for and Create “Short Term Wins”
  7. Consolidate Improvements and Produce more wins
  8. Institutionalize these New Approaches

We will need to be cognizant of the opportunity for managing change in a proactive manner so that 70% of our change initiatives to help implement innovation will NOT fail, but we will have a running start at success.

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