The Massachusetts Board of Registration in Medicine ("BORIM") recently finalized revisions to 243 CMR 2.00 (Licensure and the Practice of Medicine). These changes took effect on August 9, 2019. Because of the uncertainty resulting from certain of those changes, on September 6, 2019, BORIM issued guidance in the form of responses to "Frequently Asked Questions" ("FAQs").

We highlight below some of the key provisions in BORIM's updated regulations concerning the practice of medicine as augmented by the recent FAQs.

Informed Consent

Perhaps the most significant change concerns the new and expanded requirements concerning patient informed consent for any diagnostic, therapeutic or invasive procedure, medical intervention or treatment. The regulations require written consent signed by the patient where disclosure of significant medical information, including the risks involved, would assist the patient in making an informed decision whether to undergo the proposed procedure, medical intervention or treatment. Attending physicians not only are required to obtain and record a patient's written informed consent prior to any such procedure, intervention or treatment, but now must also inform the patient of the names of all of the individuals participating in the procedure, intervention, or treatment prior to the start time. This includes not only the names of other physicians such as the anesthesiologist or assistant surgeon but all physician extenders, such as a resident, fellow, physician assistant, advanced practice registered nurse, or other person authorized by the health care facility to participate in the procedure. Moreover, the attending physician or primary operator of a medical procedure must note in the patient's medical record if they were absent for any part of the procedure, noting the time of the absence(s) and who was the attending physician or primary operator during the absence(s).

The FAQs address a number of questions raised by the physician community about the new regulation requiring written consent:

• The regulation does not change when informed consent is needed. If informed consent was/was not required previously, it remains required/not required. However, if required, it now must be in writing.
• The regulation applies to all active physicians in Massachusetts, in any practice setting, including in the office.
• The informed consent requirement applies equally to the anesthesiologist providing routine operating room care as well as the surgeon. If the anesthesiologist needed to obtain informed consent before the new regulation, s/he will need to obtain the written consent and ensure that it complies with all the data requirements detailed in the regulation as well.
• Even if it is not known who will participate in a procedure when the informed consent is given, (such as several weeks before procedure) if before the surgery those persons become known, the new information should be added to the written informed consent and signed or initialed by the patient. While the written informed consent cannot be revised after the procedure, any new information or changes must be reflected in the patient's medical record as well as the reason for the changes, and this new information must be shared with the patient.
• It is not sufficient to provide a general disclosure, such as "we are a teaching institution and residents, physician assistants and advanced practice registered nurses or fellows will likely assist the attending physician during the procedure."
• It is not acceptable for the consent form to simply state that the attending physician will be assisted by other physicians nor to state that the attending physician may step out of the room during the procedure.
• If the names of residents or trainees participating or assisting during a procedure are not known prior to the start of the case, the written informed consent should identify the position and level of training of the individual who will be participating. After the procedure, the medical record must be updated and identify the names of everyone who participated in the procedure, and this information must be shared with the patient.
• In the situation where the attending physician leaves the operation during the surgery:
  • If the absence is anticipated, it should be part of the informed consent.
  • If the absence is unexpected, it should be recorded in the medical record and discussed post-operatively with the patient.
• In a particularly convoluted FAQ response to the question of whether written informed consent is required for such routine tests such as a hearing, balance, blood, or urine test, BORIM only stated "The regulation does not change or expand the circumstances requiring informed consent of the patient; rather, the regulation requires the informed consent be in writing" [with the various requirements detailed in the regulation]. The only concession made by BORIM was that "informed consent" was not required to obtain a patient's blood pressure.

These new requirements will likely create undue administrative burdens on physicians and hospitals, as often the identity of other practitioners (such as an anesthesiologist) is not known in advance of the procedure.

Delegation of Medical Services

The updated regulations also expressly prohibit physicians from delegating medical services to individuals who are not licensed to perform such services in Massachusetts. Important to note here, medical assistants are not licensed in Massachusetts, but they have historically provided medical care to patients when and how a physician authorizes. This requirement was confusing and caused a lot of concern in the physician community; in the FAQs, BORIM stated that medical assistants and other skilled assistants can be involved in patient care under the supervision of a licensed physician as long as they are not performing a task that requires a license (e.g., MD, PA or NP). BORIM continued that the intent of the regulation was to prohibit unlicensed persons from performing activities requiring a license to practice medicine.

Unanswered Questions

In its final FAQ, "You didn't answer, my question, what can I do now," BORIM replied that it would "continue to field questions on the new regulatory changes. If you have questions, please call our Call Center at 781-876-8230: Press 1, then Press 5." We encourage all physicians who are still confused or have questions to make that call.

Verrill has been analyzing BORIM's updated regulations and FAQs, and will continue to monitor developments in this area. For assistance with questions regarding these approved revisions, please reach out to Gary Rosenberg, Paul Shaw, or your regular Verrill attorney.