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Summer 2007

Health Law Bulletin

Massachusetts Board of Registration in Medicine Proposed Regulatory Changes
By Vanessa L. Smith, Esq.

The Massachusetts Board of Registration in Medicine (“BRM”) continues the process of revising its regulations governing the practice of medicine. On March 21, 2007, the BRM approved a new set of proposed regulations (the “Proposed Regulations”), which modify and replace its previous proposals. Below is a summary of some of the changes.

The Proposed Regulations include a section that was suggested by our office, working with other counsel to health care providers, in an effort to improve communications among health care facilities concerning practitioners with clinical privileges at multiple facilities. The Proposed Regulations include language authorizing inquiries and disclosures between and among health care facilities during a practitioner’s appointment (as opposed to just at the time of initial appointment or credentialing, as in the current regulations). We believe that these provisions will strengthen and improve peer review activities and patient care.

Disciplinary Proceedings for Physicians (Proposed 243 C.M.R. 1.00):

  • The regulations currently list 18 grounds for discipline by the BRM. The Proposed Regulations contain 27. Proposed new grounds include failing to comply with professional reporting obligations (e.g., peer reporting obligations) and failing to comply with “accepted research standards, ethics, and principles, or procedures,” or with governmental statutes, regulations, or policies regarding research.

The Practice of Medicine (Proposed 243 C.M.R. 2.00):

  • The Proposed Regulations increase the amount of post-graduate training required for full licensure: U.S. or Canadian medical graduates must have completed 2 years, and foreign medical graduates 3 years, of post-graduate medical training (up from 1 and 2 years, respectively).
  • The duration of a limited license remains 1 year. However, under the Proposed Regulations the BRM may issue a limited license for the duration of a trainee’s enrollment in an ACGME training program (for a maximum of six years) “when a specific and trainee-focused program of quality and safety exists as an integrated element of the sponsoring institution’s Patient Care Assessment Program, and said program provides documentation that it is in compliance with all the provisions of 243 C.M.R. 3.00 et seq.”

Establishment of and Participation in Qualified Patient Care Assessment Programs (Proposed 243 C.M.R. 3.00):

  • The Proposed Regulations change the definition of “Patient Care Assessment Committee” to require that the “Director of Graduate Medical Education or equivalent” shall be a member of the committee in “a health care facility where graduate medical education is given or received.”
  • The Proposed Regulations require that the Patient Care Assessment Plan be submitted every three years to the BRM for approval and that any proposed amendments to a Patient Care Assessment Plan be filed annually with the facility’s annual report (instead of when adopted or amended, as is now required).
  • The Proposed Regulations contain a section governing the credentialing of telemedicine providers.
  • The Proposed Regulations change the health care facility credentialing cycle to a three-year cycle.
  • The Proposed Regulations change the credentialing obligations of health care facilities. The licensee must provide consent to allow the conduct of a criminal background check. As to a reappointment application, the facility must make reasonable inquiry to those facilities where the applicant has had employment, practice, association, or privileges in the prior 2 years (down from 3 currently). Such reasonable inquiry need only be by “written request,” as opposed to “up to three requests in writing” under the current regulations. Added to the areas of “reasonable inquiry” is an assessment of clinical skills, “including an analysis of available complication rates and other performance data.” Health care facilities must have a process for granting disaster privileges.
  • The Proposed Regulations explicitly allow health care facilities to make “reasonable inquiry” concerning a practitioner at other facilities where he or she has privileges at “any time during the three-year credentialing cycle.”
  • The Proposed Regulations add a requirement that health care facilities with Graduate Medical Education programs develop and implement processes “to collect, investigate, analyze and trend patient outcome data in order to assure that medical residents are practicing in an environment that allows them to provide safe and competent care.”
  • The Proposed Regulations change the patient care assessment program requirements for licensee office settings to require the licensee to file an occurrence report “with the health care facility where the licensee office setting or licensee has his primary affiliation” in circumstances where there is (1) an unplanned transfer to a hospital, or (2) an unexpected occurrence from any procedure or treatment that requires sedation or anesthesia, and/or in which the known complications of the procedure may be “serious or life threatening.” The health care facility must review the reported occurrence and file an occurrence report with the BRM. If the licensee has no medical staff affiliation with a health care facility, the report must be sent directly to the BRM.

General Provisions (Proposed 243 C.M.R. 6.00):

  • The Proposed Regulations expand the definition of the practice of medicine to include: (1) the practice of telemedicine; (2) providing an independent medical examination or disability evaluation; and (3) using the designation Doctor, Doctor of Medicine, Doctor of Osteopathy, Physician, Surgeon, Dr., M.D., D.O., or any combination thereof, unless such designation additionally contains the description of another branch of the healing arts for which one holds a valid license in Massachusetts.

Data Repository (Proposed 243 C.M.R. 7.00):

  • The Proposed Regulations add a requirement that a health care facility file a report with the BRM in the case of “a suspension or termination of all privileges” within 48 hours “of the action taken by the health care facility, unless otherwise required by law.” An initial report may be made by telephone or facsimile within 48 hours, followed by a written report within 10 days.
  • The Proposed Regulations shorten from 30 days to 10 the time period for health care facilities (1) to file initial reports of disciplinary action concerning licensees; and (2) to file a final report once a disciplinary action has been completed.
  • The Proposed Regulations add a penalty for violation of reporting obligations: “upon finding a violation of this section, [the BRM shall] assess a fine not in excess of ten thousand dollars.”
  • The Proposed Regulations include a statement that, while not a reportable disciplinary action,” an oral reprimand does not relieve an individual of peer reporting obligations under G.L. c. 112, § 5F.

We continue to monitor the status of the BRM’s consideration of the Proposed Regulations. If you have any questions or comments, please contact us.

Vanessa Smith is a member of the firm’s Health Law Practice Group. She can be reached at 413-272-6213 or at vsmith@bulkley.com.