The Massachusetts Board of Registration in Medicine (BORM) recently approved significant changes to regulations governing the licensure and practice of medicine. The new regulations became effective on August 9, 2019. Physicians and health care organizations in Massachusetts would be well-advised to review the updated regulations closely – among the new provisions are regulations that will potentially affect current practices regarding the delegation of services to non-licensed individuals, procedures for obtaining informed consent, and other aspects of medical practice.

BORM’s regulations concerning licensure (and discipline) of physicians and the practice of medicine can be found at 243 Code of Massachusetts Regulations (CMR) Chapter 2. BORM initially proposed changes to its regulations in 2017 that were opposed by groups representing physicians and other providers. Despite this opposition, BORM recently approved the changes.

Delegation of Medical Services

The BORM regulations newly state at 243 CMR 2.07(4) that “[t]here shall be no delegation of medical services to an individual who is not licensed to perform those services in Massachusetts. Nothing in 243 CMR 2.07(4) shall be construed as permitting an unauthorized person to perform activities requiring a license to practice medicine. A full licensee who knowingly permits, aids or abets the unlawful practice of medicine by an unauthorized person is subject to discipline…”

The above provision replaces previous regulatory language that allowed a licensed physician “to permit a skilled professional or non- professional assistant to perform services in a manner consistent with accepted medical standards and appropriate to the assistant’s skill,” while carving out certain non-delegable medical services.

The revised regulations also provide that “[t]he interpretation of blood pressure recordings by any method is the practice of medicine,” which coupled with the new prohibition on delegation of medical services, suggests that medical assistants and other unlicensed individuals may no longer be delegated the task of interpreting a blood pressure recording in Massachusetts.

Informed Consent

The regulations set forth detailed new requirements addressing a physician’s obligation to obtain and record a patient’s written informed consent before procedures and other medical interventions or treatments. Under the regulations, informed consent refers to where a physician “has disclosed and explained to the patient’s satisfaction the process used to arrive at the medically reasonable and recommended procedure, intervention or treatment, based on reliable evidence of the expected benefit and risk of each alternative, free from any impermissible bias.” As part of that process, patients and their representatives must be given an opportunity to ask questions and receive satisfactory answers.

In connection with this new informed consent requirement, the regulations obligate physicians to have written policies and procedures regarding the informed consent process. According to the regulations, at a minimum the policies must address:

(i) the procedures and treatments requiring informed consent;

(ii) the content of information to be provided to patients and representatives;

(iii) the persons responsible for obtaining informed consent;

(iv) how informed consent will be documented; and

(v) who and when someone other than the patient may provide informed consent on the patient’s behalf.

Ultimately, the regulations provide that it is the responsibility of the attending physician/primary operator to obtain written informed consent, and to discuss medical information with the patient to enable the provision of informed consent. Additionally, per the regulations, a patient’s medical record must indicate who will participate in a particular procedure, and any absence of the attending physician/primary operator during a medical procedure, intervention or treatment must be documented in the patient’s medical record. The attending physician/primary operator is a new defined term in the regulations that refers to the physician credentialed by a facility to perform a patient’s procedure, intervention, or treatment, and to supervise participating trainees or physician extenders.

Infection Control

BORM’s regulations require all physicians to implement and maintain infection control policies and procedures tailored to the care setting and the patient population. At a minimum, the regulations require infection prevention techniques that will apply to all settings to include: (i) hand hygiene; (ii) use of personal protective equipment (e.g., gloves, gowns, masks); (iii) safe injection practices; (iv) safe handling of potentially contaminated equipment or surfaces; and (v) respiratory hygiene.

Notice to BORM of Termination or Suspension of Privileges

Health care facilities in Massachusetts – including hospitals, clinics, and nursing homes – are now expressly required by BORM’s regulations to provide BORM two business days’ notice of the suspension or termination of a licensed physician’s privileges. Notice can also be given to BORM by phone or facsimile, with a written report filed 30 days thereafter.

Medical Records

BORM’s final updated regulations do not contain an earlier proposal to extend the mandatory retention period for physician medical records from seven to ten years, and therefore that requirement remains as seven years “from the date of the last patient encounter” or, in the case of a minor patient, seven years “from the date of the last patient encounter or until the patient reaches the age of 18, whichever is the longer retention period.”

BORM implements new requirements for executors or administrators of the estates of deceased physicians. These individuals are required to retain the medical records of the deceased physicians’ patients, and provide reasonable access upon request of the patients, for a minimum period of seven years from the date of the last patient encounter.

Physician Discipline

Currently, there is an exception to mandatory reporting of licensed physicians to BORM in the event of a reasonable belief of substance use disorder impairment, as long as there is no allegation of patient harm and the physician is in compliance with a drug or alcohol treatment program.

The new regulations narrow that exception (now referred to as an “exemption”), requiring compliance with an additional condition and expanding one of the current conditions. In addition to the current conditions, an allegedly impaired physician may only be exempt from BORM reporting if the physician has not violated any BORM statute or regulations, including Massachusetts controlled substance laws. The regulations also now provide that the physician’s involvement with alcohol or drugs cannot involve an allegation of patient harm, or of any impairment occurring at the physician’s workplace or while the physician is “on call,” in order to qualify for the exemption.

Licensing

BORM has also made changes to the requirements for obtaining and renewing a physician’s license. Under the new regulations, in order to obtain a license or renew an existing license, a physician must participate once in a training course in domestic violence and sexual violence, and once in training on child abuse and neglect.

Under the new regulations, all Massachusetts-licensed physicians are now required to apply for participation in MassHealth as a condition of licensure, and can do so either as a provider of services, or as a non-billing provider who orders and refers services provided under the MassHealth program.

Additionally, applicants for licensure will now be required to provide information and documentation on any malpractice claims, and on any criminal proceedings in which the applicant was a defendant (other than minor traffic violations).

Conclusion

BORM’s new regulations contain a number of significant changes that are likely to affect how physicians and other providers currently practice and furnish health care services in Massachusetts. It remains to be seen whether BORM will offer additional guidance to licensees on the new regulations, and particularly whether BORM will allow for flexibility in enforcement of certain provisions. Health care systems and physicians groups would be well-advised to review the new regulations, and their policies and procedures, to ensure that they continue to practice in a compliant manner.

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