Health Care Reform, Accountable Care Organizations, Practice Guidelines and the Corporate Practice of Medicine
A century ago states began to codify prohibition of the corporate practice of medicine. Some states have statutes, some rely on attorney general opinions, and some rely on case law. In many states, combinations of these instruments and opinions have shaped the legal environment. The prohibition of “corporate practice” stemmed primarily from the ethical concern that corporate profits might influence physician clinical decision making. In fact the impetus seems to have been more aimed at restricting the types of business arrangements in which physicians could engage than at putting a check on excess corporate profits.
Now the health care landscape is far more complex. However the concerns over how external financial pressure might influence the doctor patient relationship should not disappear. Even the most sophistocated consumer of health care services could not be expected to anticipate where these pressures lie and how they might be manifested.
In Illinois, for example, important court cases of the past decade have dealt with the issue of hospital employment of physicians (they can) (Berlin v. Sarah Bush Lincoln Heath Center). This decision extablished the legality of hospital employment of physicians but left standing other prohibitions of the corporate practice of medicine. Most decisions of this type accross the country include the caveat that the employment must not directly influence a physicians clinical decision making.
Another case dealt with how physicians may share fees with corporate managed care (they may not, at least not on a sliding scale basis) (Vine Street Clinic, et al. v. HealthLink Inc). Both of these cases reflect the more general societal unease over how physicians might have their clinical judgement influences by external forces.
Ironically after the passage of health care reform, the next agenda item for congress is prohibition of certain behaviors of bankers who are widely held responsible for the last financial melt down. But has congress shifted its attention too soon? While they scrutinize the banking industry and legislate new ethical standards will the new health law lead to different, yet still huge, financial manipulation in the health care industry? The banks have long been regulated. The new health law will ultimately lead to enormous proliferation of state and federal regulations. Patients are in danger of becoming pawns in a very complex game.
No politician dares to utter the "R" word in the health care debate. Yet an unavoidable component of "controlling costs" will involve rationing of services ala the British system. Lamenting the enormous sums spent in the final weeks of life is one thing. Identifying the exact day each patient begins that count down is another. Prevention only postpones the judgment day. So rationing will occur disguised by euphemisms like "comparative effectiveness" (a research initiative created and funded in the new Act).
We are now just entering that new era of rationing of health care with the passage of the 2010 Healthcare Reform Act in Washington. Literally within minutes of the act being signed into law by the President several states filed legal challenges. Like virtually all legislation from Washington, a subtitle to the bill could read “The Lawyer, Accountant and Bureaucrat Relief Act of 2010”. Likely it will take a least a decade of promulgation of rules and adjudication of administrative law and civil court cases to know what the legal ramifications of the act are.
Among the many issues addressed or mandated in the bill is a pilot to test a prospective payment system with a much more global scope than the current Medicare “DRG” system for hospital acute care episodes. The Act calls for the formation of Accountable Care Organizations (ACO’s) that will receive prospective payment for the care of certain groups of patient. This will require a structure that puts physicians in the same ethical conundrum that led to the various prohibitions of corporate practice a century ago.
Directly or indirectly (but always by a codified scheme that will have to pass legal muster in each state) physicians will share in the profits or losses of the ACO. This will be true whether the ACO is structured as a for-profit or a not-for-profit. To avoid the unbearable ethical dilemma of rationing health care one decision and one patient at a time, practice guidelines will be needed. Some method of corporate enforcement by carrot and stick will also be needed so that the guidelines are applied fairly and uniformly.
When, exactly, does the institutional, corporate implementation of “guidelines” become the corporate practice of medicine? For example, a complicated immune compromised hospital patient had a change in clinical status with fever. Her physician was contacted and she ordered an (expensive) antibiotic to be given immediately (“stat”) according to the FDA approved dosing scheme. But the hospital had a corporate guideline that automatically changed the order from a stat intravenous bolus dose to a slowly infused dose. The corporate guideline resulted in a 25% drug cost savings to the corporation since it results in 3 doses per day instead of the “standard” 4 doses.
This guideline was adopted according to corporate policy and procedures with the input of several hospital employed physicians. However, none of these physicians was directly involved in the patient’s care. The pharmacokinetic “greater area under the curve” rationale for the changed slower dose scheme has some merit. The rationale for immediately achieved high therapeutic antibiotic blood levels in a blood stream infection also has merit. No conclusive “evidence based” prospective clinical trial data exists to resolve the question of when (if ever) one dose scheme is superior to the other.
Even the term "guideline" is a euphemism. A guideline that automatically alters an attending physician's order, even over his written objection, is not a guideline.
Is this an example of the corporate practice of medicine?
Other examples are even more complicated. The hospital has a corporate directive that all patients being admitted have nasal swab screening for “MRSA” (a nasty, antibiotic resistant bacteria that can cause lethal infections but which is most often innocuous to asymptomatic nasal carriers). Patients are not offered the option of refusing the screening test. This example approximates the rationale for public health authority’s strategies for control of epidemics, which can include involuntarily quarantines, etc. But hospital corporations are not legally vested with the same statutory authority as public health officers.
Why would a patient care if he were screened or not? If he screens positive he will received “decolonization” of the nose and skin with antibiotic ointment and disinfecting chemicals. This has not been proven to be beneficial to the carrier (or for that matter to anyone) and is at best inconvenient and modestly uncomfortable. Exposure to the chemicals and antibiotic may also carry a very small risk to the carrier. The carrier will be put into isolation where visitors must don gowns and gloves. Health care providers must do the same. The net result may result in fewer contacts with friends, family and care givers. The carrier state may also lengthen hospital stay as many post hospital care facilities are reluctant to accept MRSA carriers. The carrier label will follow the patient and future hospital admissions will require automatic isolation per corporate guidelines.
Is this an example of the corporate practice of medicine?
These kinds of situations are not rare now and will become common place as guidelines are imposed by corporate authorities. Physicians who now are often self employed and relatively free to disagree with (and sometimes over ride) practice guidelines will become corporate employees. Ironically, corporate providers are hiring “patient care advocates” to smooth the path to implementation of guidelines. “Patient advocate” used to be part of the job description of physicians.
reform