Recent decisions by CMS and a Maryland professional board demanding significantly more specific disclosures in informed consent forms have potentially raised the stakes in the ongoing effort to balance patient autonomy with the practical concerns of providers in an effective consent process. Facilities should be aware of current requirements and stay abreast of developments that may create new or unexpected liabilities.

In May 2004, CMS issued a revision of its Internet-only State Operations Manual (SOM) that provided new requirements for informed consent applicable to hospitals complying with the Medicare Conditions of Participation. While the underlying regulation at 42 C.F.R. § 482.24(c)(2)(v) remained unchanged, the new SOM guidelines require that informed consent forms list both the physician who will perform the procedure, the "primary physician," and the names and specific surgical tasks that will be performed by practitioners other than the primary physician. Hospitals may be in violation for failing to identify in advance both the name of practitioners who will assist in surgery and their specific duties during the procedure.

It has not taken long for state authorities to follow in CMS's footsteps. In May of last year a Maryland professional board made several decisions implying that CMS's demand for increased consent form specificity was not falling on deaf ears. The board required, as a licensing prerequisite, that certain practitioners use a consent form that identifies, by name, both the primary physician prescribing the procedure and the practitioner who will perform it. Increasing the specificity of information provided to patients may be ethically desirable, but it may have an unintended impact on physician and facility liability and, as a result, overall health care costs.

Informed consent law is state law. Maryland's law, for example, is founded in Sard v. Hardy, 281 Md. 432 (1977). Mrs. Sard claimed that her physician failed to disclose to her important information, including the failure rate of the operation and other, potentially more reliable, treatment options. In announcing its decision, the Court of Appeals also announced the legal standard that still governs informed consent in Maryland and many other states: patients must be told that information which a physician knows, or should know, would be material to a person in the patient's position in deciding whether or not to proceed with treatment.

Dingle v. Belin recently clarified that in Maryland, as in many other states, a physician may be liable under theories of contract if he or she diverges from a specific, negotiated informed consent. Dingle v. Belin, 358 Md. 354 (2000). Ms. Belin claimed that Dr. Dingle had agreed that he himself, not any resident, would perform both the retraction and cutting required to remove her gallbladder, even though it would be impossible for a single physician to perform both tasks. The cutting was in fact performed by a resident, while Dr. Dingle observed, directed, and performed the necessary retraction. Following complications, Ms. Belin believed she had a claim for failure to obtain informed consent because a resident, not the physician, did the cutting. The Court of Appeals agreed, noting;

A physician who agrees to a specific allocation of responsibility or a specific limitation on his or her discretion in order to obtain the consent of the patient to the procedure and then .proceeds in contravention of that allocation or limitation has not obtained the informed consent of the patient .. [V]iolation of an understanding so reached may constitute the lack of informed consent, negligent delegation, and a breach of the contract, not to mention the risk of a claim of misrepresentation or fraud.

Dingle, 358 Md. at 370-371; 377. The court noted that this kind of contractual informed consent liability had already been recognized by the First Circuit (applying Massachusetts law in Alexandridis v. Jewett, 388 F.2d 829 (1st Cir. 1968)), Massachusetts (Forlano v. Hughes, 471 N.E.2d 1315 (Mass. 1984)), New Jersey (Perna v. Pirozzi, 457 A.2d 431 (1983)), and Pennsylvania (Grabowski v. Quigley, 684 A.2d 610 (1996)).

The new policies of CMS and the Maryland professional board may or may not be in the best interests of patients, but they will likely expand the basis for malpractice liability, at least in Maryland and perhaps in other states as well. This shouldn't come as a surprise — studies in both Canada and the United States have come to the conclusion that increasing the specificity of informed consent forms also increases the frequency of malpractice suits. See Donald N. Dewees, et al., The Medical Malpractice Crisis: A Comparative Empirical Perspective, 54 Law & Contemp. Probs., 217, 242-243 (1991). When these suits are brought, they will be brought not only against individual physicians, but also against hospitals and other facilities, under theories of "corporate liability" or respondeat superior.

Hospitals and other facilities should become active participants in the development of guidelines governing informed consent procedures and facility liability before they find themselves facing malpractice accusations as a result of policies and procedures they believed to be both legal and ethical. The American Medical Association has already released a resolution from its House of Delegates, advocating against both the application of the new SOM to teaching hospitals and the adoption of any similar language by JCAHO. CMS has indicated that it will mitigate the effect of the SOM on teaching hospitals when it next revises its Internet-only SOM, but that is only a temporary solution to an overarching conflict between providers' practical need for flexibility and the recent ethical thinking that demands greater and greater specificity. Hospitals should advocate with state and federal authorities against excessive increased consent form specificity when specificity will likely only increase liability and overall health care costs. Taking the time to explain the facility point of view now may mean avoiding a costly regulatory fight later.

More importantly, facilities should ensure that they are not already at risk. Any facility that uses consent forms should ensure that those forms meet current legal requirements and are amenable to revisions, as necessary, to meet the requirements of increased specificity that may be forthcoming. Facilities should begin the process of identifying procedures ripe for change now, before they are required to do so. Perhaps most importantly, facilities should meet with their physicians to make sure that they are aware of the liability that may be created by a well-intentioned promise of special attention, specific service, or even specific information to a patient.

Increased patient knowledge is a laudable goal, but it need not unnecessarily increase facility costs and liability. A practical consent process should recognize the role of physicians, residents, and non-physician practitioners without allowing that recognition to become the basis for additional liability. With a combination of advocacy and preparedness, facilities can help government agencies inform and educate patients while ensuring that new requirements are not so broad and invasive as to impede physicians' ability to administer the health care system on which we have come to rely.