How physicians not adhering to clinical guidelines may be punished

The Justice Department decided to weigh in on the topic of clinical guidelines.

As if to underscore Dr. Rich’s assertion that “guidelines are no longer guidelines,” the Federal government has raised the prospect of fining your doctor and/or sending her to prison for the crime of not strictly following guidelines of care.

As reported by MedPage Today:

“Federal prosecutors are looking into physicians’ prescribing practices relating to implantable cardioverter defibrillators (ICDs), the Heart Rhythm Society has told its members.

In a mailing sent to HRS members, the group said it had been contacted by the Department of Justice to assist in a probe of ICD prescribing.

“[HRS] has agreed to assist in an advisory role to lend expertise concerning proper guidelines for clinical decision making,” according to a copy of the notice posted by two members on the Internet.

The notice indicated that the society was prohibited from commenting further on its role in the investigation. Justice Department officials could not be reached for comment.

It was therefore unclear whether the probe is related directly to a report in the Journal of the American Medical Association recently indicating that ICDs are often prescribed for patients who don’t qualify for the devices under published guidelines…

The HRS notice appears to raise the possibility that the Justice Department may be considering prosecution of individual clinicians, in addition to its already disclosed investigation into alleged payola schemes by ICD manufacturers.”

If the Justice Department investigation is, in fact, going to target clinicians based upon their adherence to guidelines, the American healthcare system is headed down a very slippery slope.  Government regulators and prosecutors will, of course, contend that they’re simply looking for “waste, fraud and abuse”, and that looking for non-adherence to guidelines is a reasonable screening tool when looking for criminals.  But let’s not kid around.  Any such policy is going to have a chilling effect on treating patients as individuals rather than statistically average widgets.  You may need a test or procedure as a part of good medical care, but your doctor is going to be too scared to order it if her record of “guideline compliance” is at stake.

Think about it.  For the first time your doctor may have a real choice to make if your medical condition doesn’t happen to fit neatly into some academic cookbook.  Adhere to the guideline and commit malpractice, or violate the guidelines and risk jail time.

Using guidelines in this way is unscientific, unethical and just plain wrong.

Doug Perednia is an internal medicine physician and dermatologist who blogs at Road to Hellth.

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  • mrpickles

    Never underestimate the unintended and intended consequences of both well meaning and not-so-well meaning individuals or entities actions to substantiate their rally cry for rooting out waste, corruption, or injustice.

  • Steven Reznick MD

    A few years back a ” teaching institution” in California was found to be performing numerous cardiac catheterizations and interventional procedures on individuals with normal coronary arteries. It was alleged that this was an institutional policy and both physicians and hospital staff were disciplined by authorities. If in fact a similar pattern is occurring repeatedly at certain institutions and the government is paying the fees through Medicare or Medicaid then it is certainly reasonable to look at the reasons behind the decision making. This is in marked contrast to individual practitioners making a clinical decision to insert a device in a patient at a particular time based on the clinical situation. This one needs to play out before we all get up in arms over additional governmental invasion of the clinical arena. In most cases of insertion of an AICD there is a generalist, a cardiologist and an electrophysiologist involved in addition to the patient granting consent. No clinician will want to have to gain approval of the Justice Department to care for a patient in an ” off label” clinical situation .

  • Dr Alex Concorde BSc MBBS PhD MBA

    Given that safety is amply covered by existing practices and by inherent professionalism within Medicine, this has to be a chilling step in the wrong direction… taking us yet further away from a more evolved paradigm in which clinicians may judiciously interpret clinical guidelines in light of a given individual’s own presentation and their experience – rather than being forced to make robotic ‘decisions’ based of weighted averages, and inadequately utilising/merely citing ‘clinical acumen’.

    • Dr. Niroshan Sivathasan (BSc, MB,BS, DipAesthMed, MRCS(Eng), MBA)

      I very much agree with your sentiments. It appears that loss of autonomy and deprofessionalization are creeping-in on numerous fronts. I fear that this is a slippery slope down, and once such strengths are lost, they shall be lost forever. It sometimes feels as if there is a push (read as ‘democratization’) to make doctors into ‘nurse practitioners’ and technicians – people who just follow protocols – and that independent, lateral thinking (read as ‘thinking outside of the box’) is being suppressed.

  • Barbara Hales, M.D.

    These actions should come as no surprise. The writing is on the wall.

    Part of the electronic health system is to have “suggested” protocols when the diagnosis and symptoms are keyed in.
    If the doctor veers from the protocols, he/she must enter the reasoning behind it in the notes. These notes will be monitored by the government.

    Questions to ask are:
    *Who is devising this set of protocols?
    *Are the guidelines based on cost or the best option?
    *Will physicians lose the right or ability to devise protocols that are individualized for each patient and ones that the provider feels is in the best interest of the patient?
    *Will the doctor become unable to offer various options if they are more expensive?

    As the medical community moves forward and transitions to electronic records, it will be much easier for “big brother” to monitor treatments. Good for some (protective), bad for many.
    Incidentally, what will the government do with all the “personal” information?

  • mrpickles

    He who pays makes the rules. If you accept the money, you’re unofficially employed, and thus must follow their rules regardless of who makes them.

  • paul

    ahh… but the question is, who will be on the hook for personal financial ruin if the guidelines are followed and turn out to be wrong for that individual patient?
    the person who wrote the guidelines?

  • Matthew Bowdish

    This is hardly surprising given CMS Director Berwick’s own ideas on the patient-physician relationship, which he seems to believe is a problem.

    “Traditional medical ethics, based on the doctor- patient dyad must be reformulated to fit the new mold of the delivery of health care…Regulation must evolve. Regulating for improved medical care involves designing appropriate rules with authority… Health care is being rationalized through critical pathways and guidelines. The primary function of regulation in health care, especially as it affects the quality of medical care, is to constrain decentralized decision making.”

    As for Mr. Pickles’ assertion that because you take money from someone, you have to do everything they want you to, even if that is morally wrong, we physicians know the dangers of such a cynical attitude. But Pickles does make an important point that real health care reform should be patient-centered, not CMS-centered, not HHS-centered, not AARP-centered, not waiver-centered, and not Big Insurance centered. Berwick falsely claims that destroying the doctor-patient dyad and turning decisions over to ACOs, the IPAB, etc., is ‘patient-centered.’ He is wrong and growing public opposition to this health control law will eventually lead to real reform.

  • Jeff Taylor

    This is a scaremongering post. It’s clear that there is a large ‘industry’ going on in kickbacks to doctors for becoming ‘consultants’ in using new medical devices and drugs, and we’re seeing some massive fines as a result. I see no reason why we can’t use guidelines to expose outlying patterns of non-evidence based medicine. Those who oppose guidelines must show how they would tackle the problem.

    • elmo

      The problem with your argument is that most guidelines are NOT level 1 (randomized control trial), they are level 2 or 3 which is by and large expert opinion. Expert opinion is not “evidence-based”. Also those academic “experts” who may (or may not) be taking money from industry are writing those same guidelines. See the conflict of interest here?

      • Jeff Taylor

        We usually have level 1 evidence for the gold standard of care. What we should not be doing is rushing to implement new technologies with poor evidence of effectiveness, and even more so we should be looking at whether the standard of care is actually being followed.

        And on this last point see this story in the LA Times on excess cardiac deaths owing to physicians not following guidelines –

        • elmo

          Jeff respectively you are missing the point and I will give you an example. In the JCO in 12/2010 Poonacha et al published a paper that systematically looked at the evidence behind the NCCN guidelines (National Comprehensive Care Network a consortium of the largest NCI-designated comprehensive cancer centers in the USA). The results (from the paper) :”Of the 1,023 recommendations found in the 10 guidelines, the proportions of category I, IIA, IIB, and III EC were 6%, 83%, 10%, and 1%, respectively” . Granted cardiology is not oncology BUT randomized controlled trials are expensive and time consuming either way. Guidelines based on e level 1 evidence are by and large a small minority of guidelines out there. Conclusion: Docs shouldn’t be “punished” for not adhering to non level 1 (the vast majority) of guidelines, though on level 1 guidelines not followed there should be an explanation as to why in the chart.

  • Peter English

    Given that real world patients and situations are far to complex and varied for any set of guidelines to cover them, the logical conclusion of courts deciding that guidelines have to be followed slavishly, even against the best interests of patients, is that we should stop producing guidelines.

    I do wonder, however, whether the guidelines that the courts have attempted to misapply were written in overly prescriptive terms.

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