Beyond Informed consent

The Patient Protection and Affordable Care Act includes a program called “shared decision-making,”¹ which provides funding to non-governmental organizations to develop “patient decision aids” that are to help “patients, caregivers or authorized representatives…decide with their health care provider what treatments are best for them based on their treatment options, scientific evidence, circumstances, beliefs, and preferences.”² Even further, states such as Washington passed a bill (ESSB 5930) that creates a presumption of informed consent if a practitioner uses shared decision-making aids. Using Washington as a guiding post, Massachusetts should pass a bill that provides immunity from suit under state informed consent law for physicians who use PPACA-certified patient decision-making aids.

For purposes of background, informed consent often serves various functions including protecting individual autonomy, protecting the patient’s status as a human being, avoiding fraud or duress, encouraging doctors to be diligent in decision-making, foster rational decision-making by the patient, and involve the public into the field of medicine.³ There are generally two types of standards for informed consent – the physician-based standard and the patient-based standard. Physician-based standards generally require physicians to inform a patient of the risks, benefits and alternatives to a treatment in the same manner that a reasonable doctor under the circumstances would inform.⁴ On the other hand, patient-based standards hold physicians responsible for providing patients with all information on the risks, benefits and alternatives to a treatment that a “reasonable patient” would attach significance to in making a treatment decision.⁵ Both standards contain flaws in that patient’s needs and preferences vary and that doctors possess different understandings of the best course of treatment. As such, the standard of shared decision-making aids has taken form.

Such shared medical decision-making is defined as “a process in which the physician shares with the patient all relevant risk and benefit information on all treatment alternatives and the patient shares with the physician all relevant personal information that might make one treatment or side effect more or less tolerable than others. Then, both parties use this information to come to a mutual medical decision.”⁶ Proponents of shared decision-making could argue better quality of care through increased patient autonomy and comprehension, decreased unwanted medical procedures, and increased patient and physician communication. Essentially, shared decision-making would aid in ensuring that patients can meaningfully participate in their health care. On the other hand, many may argue that such decision-making will take too much time and that there are not enough resources for physicians to provide all evidence needed for a willing patient to understand.

With regards to the issue of immunity for implementing patient decision-making aids, there will likely be varying schools of thoughts. Some will argue that immunity gives physicians too much protection from potential liability for basic negligence. Others may suggest that immunity would shift the focus from what a reasonable patient needs to know to what doctors believe a patient should be told. Further, if a competent patient signs an acknowledgement of shared decision-making, it constitutes evidence that the patient has given his or her informed consent, that can only be rebutted by clear and convincing evidence, which acts as a higher standard of defense for physicians. This higher standard of defense could potentially lead to physician neglect, whether intentional or unintentional as a seemingly more simple patient decision-making aid could take the place of real conversation.

On the other hand, when a physician and patient collaborate in the treatment decision, they are prioritizing patient autonomy as the physician is taking action that serves the best interests of the patient. In instances of disagreement after discussion, the patient’s preference should determine the treatment, since the patient has to live with the decision and its implications. By protecting patient autonomy and acknowledging the importance of the physician’s opinion and analysis, such immunity provides an effective method of enabling physicians to satisfy their ethical obligations to patients.⁷

Ideally, patients and physicians should communicate with one another regarding treatment options in order to mutually define the best course of treatment. In many ways, our current legal standards inhibit such a discussion as physicians are constantly worried about liability and patients do not always make decisions based on their beliefs. Rather than requiring patients to have blind faith in their physicians or requiring physicians to only provide statistical information but not their professional opinion, an informed consent standard that encourages open communication, shares input and responsibility between physician and patient, and reestablishes the physician patient relationship should be instituted.

Accordingly, a bill giving immunity to physicians who use patient decision-making aids appears a natural progression for both better patient care as well as greater time and flexibility for physicians. If providing immunity or partial immunity for physicians using patient decision-making aids allows (1) patients more autonomy in their medical decisions and more opportunity to consider their own value systems in their treatment options and (2) physicians greater confidence and flexibility regarding their legal liability so that they can generally improve the health outcomes of their patients by enabling them to be more invested in the treatment choice, such a bill should be implemented.

Namita Agarwal is AyerHoffman's Health Law & Policy Contributor. Ms. Agarwal is currently a J.D. candidate at Northeastern University School of Law where she concentrates her studies on domestic and international health care, welfare, and immigration law.