Friday, March 7, 2014

CCE and the Road to Hell

In a recent law proposed in Congress the intent is to eliminate liability if the physician follows a standard method of care[1]. Thus there is a “Safe Harbor” established. The article states:

Physicians who are Medicare and Medicaid providers would be granted increased liability protection if they can demonstrate that they followed established clinical guidelines, according to a bill introduced in Congress this week. The Saving Lives, Saving Costs Act, introduced by Reps. Andy Barr (R-KY) and Ami Bera (D-CA), would create a "safe harbor" for physicians who follow best practice guidelines. Physicians also could request that state-level malpractice suits be moved to federal courts.

The concern is that the Safe Harbor is established by following a Comparative Clinical Effectiveness standard established by the Government. The article states:

"Rather than being directed by Washington, the guidelines will be developed by the physician community based on the best available scientific evidence," according to a joint statement by the legislators. "Guidelines should be developed through a transparent process by a knowledgeable, multidisciplinary panel of experts." A physician who is being sued could "argue that he or she adhered to the relevant practice guidelines, which would cause a suspension in the proceedings while an independent medical review panel investigates." If the panel determines that the physician conformed to the guidelines, or that failure to conform was neither the cause nor the proximate cause of the alleged injury, the case would be dismissed pending clear and convincing evidence that the medical review panel was in error, the statement said.

Now this has certain concerns. Specifically those relating to CCE Standards. The problem with them are:

1. They are not patient specific. They are patient general and the fact of the matter is patients are all different. Thus by following the “Standard” it may actually cause harm to the patient.

2. The development of a consensus for Standards is a timely process. It also is one that all too often reaches a least common denominator. It also, if one see the results of the ACA, may be driven by both non-physicians and worse, physicians having no expertise in the area of the “Standard”. One need look no further than the USPTF and the Prostate Cancer debate as well as the proposed standards emanating from PCORI, where “patients” get to opine on what is correct.

3. Standards when delivered often are reached after extensive developments may have occurred in the treatment and studies. Thus Standards reflect a substantial time lag in the process. The adherence to “old” practices again may result in poorer levels of care.

4. Standards are also now used to manage the physician. The physician, if in fear of a law suit, will be forced to adhere to the Standard and thus not use their own judgment and patient specific information.

5. Standards can be used to penalize the physician as well as set limits on care. It can in a way be a back door way of rationing health care. Standards developed by Government bodies of political appointees are clearly a mechanism under the current Administration to delimit care and reduce costs.

Thus this Bill, with possibly some good intentions, will reduce the level of health care. One must remember that the road to Hell is lined with such “good intentions”.