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House of Representatives
Session of 2021 - 2022 Regular Session


Posted: January 4, 2021 03:07 PM
From: Representative Paul Schemel
To: All House members
Subject: Informed consent under MCare (Prior HB 1580)
In the near future, I plan to reintroduce legislation that seeks a legislative fix to address the Pennsylvania Supreme Court’s interpretation of the Medical Care Availability and Reduction of Error (MCare) Act regarding a physician’s ability to delegate the duty to obtain the informed consent of a patient prior to specified procedures.  Under section 504 of MCare, a physician has a duty to obtain the informed consent of a patient or a patient’s authorized representative prior to conducting the following procedures:
(1) Performing surgery, including the related administration of anesthesia.
(2) Administering radiation or chemotherapy.
(3) Administering a blood transfusion.
(4) Inserting a surgical device or appliance.
(5) Administering an experimental medication, using an experimental device or using an approved medication or device in an experimental manner.
In June 2017, the Pennsylvania Supreme Court ruled, in a 4-3 decision in the case of Shinal v. Toms, that physicians have a non-delegable duty under MCare to obtain a patient’s informed consent.  Additionally, the Court ruled that communications between a physician’s qualified staff members and patients will no longer be admissible at trials as to the issue of whether the physician obtained informed consent.
This ruling severely hampers the concept of team-based care and ignores the realities of present-day health care.  It further takes away a physician’s medical expertise and judgment in determining how best to serve his or her patients.  As the dissent noted, “For fear of legal liability, physicians now must be involved with every aspect of informing their patients’ consent, thus delaying seriously ill patients access to physicians and the critical services that they provide.” Shinal v. Toms, 162 A.3d 429, 459 (Pa. 2017) (Baer, J., dissenting).  This ruling now precludes health care facilities and physicians from utilizing qualified practitioners in the informed consent process, which means that qualified staff can no longer assist with providing information, answering questions, or following up with patients prior to surgical procedures for fear of legal liability.  This ruling inhibits much of the team-based care that facilities and physicians rely on in an ever-demanding health care world.
My legislation will:
  • Clarify that while physicians remain responsible for the overall care of their patients, the task of obtaining a patient’s informed consent may be delegated by a physician to qualified practitioners.
  • Allow health care facilities and physicians to develop policies and procedures regarding informed consent concerning when qualified practitioners other than physicians may obtain informed consent.
  • Allow physicians and other qualified practitioners to rely on information provided by another qualified practitioner to obtain the informed consent of the patient and allow this information to be used as evidence in a proceeding in which it is alleged that the physician or other qualified practitioner failed to obtain informed consent.
  • Clarify informed consent requirements in human research conducted pursuant to approval by an institutional review board (IRB) or similar entity.
  • Clarify when a physician or qualified staff person is required to obtain a separate or new informed consent from a patient when informed consent was already obtained.
This legislation was drafted by the Pennsylvania Medical Society (PAMED) and The Hospital and Healthsystem Association of Pennsylvania (HAP) and has the support of both organizations.
Physicians are highly valued members of the medical community.  While they should be held to very high standards, we must provide them with the ability to determine when to employ the assistance of other qualified practitioners within a framework that still ensures patients are protected and have access to information they need to make informed decisions about very important health care matters.
Please join me in sponsoring this important piece of legislation that will reinstate a team-based approach to health care and ensure that physicians and other health care practitioners can focus more time on patient care and provide patients access to physicians and the critical services they provide.

Introduced as HB1022