Board of Medicine regulations in flux - Winter 2006

Board of Medicine regulations in flux

Feature Story. Massachusetts Medical Law Report, Winter 2006

By Paul Cirel

Imagine if you were a professional baseball player, and you arrived at spring training only to discover that base stealing was no longer allowed, the infield fly rule was abolished and games would now be played in eight innings.

Maybe not as dramatically as that, but some time in the spring the rules that govern what you do for a living are going to change.

In early October, the Massachusetts Board of Registration in Medicine announced its intention to amend its existing regulations and to adopt new ones concerning, among other things, "the licensing of physicians ... the practice of medicine ... the grounds for discipline ... [and] the initiation, investigation and disposition of complaints and reports." In other words, the Board is undertaking a wholesale revision of the regulations that govern just about everything physicians do.

Before addressing the nature of the Board's proposed revisions, a word about the regulatory process might be instructive. Prior to any proposed regulation becoming law - and make no mistake about it, duly promulgated agency regulations have the same force and effect as any law enacted by the legislature - the sponsoring agency must first provide notice of the proposed changes or additions and an opportunity for comments.

Some agencies - including the Board - must schedule and conduct public hearings before making any changes to their regulations. In the usual course, an agency considers the comments it receives over the 30-day period following the hearings and makes any revisions it deems appropriate. The regulations are then certified by the Secretary of State and published in the Code of Massachusetts Regulations (CMR).

Proposal and process

Now, as to the current revisions, the Board issued its initial notice of "proposed amendments to existing regulations and adoption of new regulations" on Oct. 13, 2005 and scheduled public hearings for Oct. 27 in Springfield and for Nov. 30 in Boston.

The proposed regulations were (and remain) posted on the Board's website (www.massmedboard.org). Had the initial schedule been followed, new regulations likely would have taken effect in January 2006.

Apparently, however, the scope and depth of the comments that were presented at the October hearing in Springfield - including, most notably, from the Massachusetts Medical Society (MMS) - were overwhelming.

On Nov. 22, the Board announced a change of plans: the scheduled Nov. 30 public hearing was shelved in favor of an "informal information session." The Board said its purpose in doing so was to "solicit additional comments from interested parties" with an eye toward incorporating that input into a "revised version" of the proposed regulations.

The Board's announcement went on to say, "[F]ollowing consideration of comments received on Nov. 30 ... the formal public hearing process will be re-started. The Board anticipates the formal process to recommence in early January 2006 and conclude in early March 2006."

In other words, the Board has committed to taking the comments it has already received under advisement, not for the usual purpose of issuing final regulations, but rather for the purpose of issuing a second draft of proposed regulations for further review and comment. You should hope that this rather unique departure from the standard regulatory process signals the Board's recognition that some of the proposed changes missed the mark. Regardless, the revised draft will at least provide a telling measure of the Board's willingness to respond to the constructive critique of the profession it governs.

Key areas of concern

It would be impossible to even attempt a summary of either the original 81 pages of proposed regulatory changes and additions, or the extensive comments and testimony those proposals engendered. On that score, I again refer you to the Board's website (for a copy of the proposed regulations) and to the Board's public information office (for copies of the written comments that have been submitted).

That said, many of the comments focused on what is perceived to be a consistent and troubling theme of the Board's initial proposal: a disproportionate focus on discipline.

As the MMS pointed out, the newly created section on Enforcement Provisions ominously begins by recasting the former "Grounds for Complaint" subsection as "Grounds for Discipline." And the list of those "grounds" has grown from eighteen to thirty. Noteworthy examples among the newly created bases for the Board to discipline physicians under the proposed regs include: committing an act that violates recognized standards of care; violating a Board policy; and failing to comply with a Board subpoena. As discussed below, those additions should be grounds for concern.

Subjecting a physician to discipline for an act that violates recognized standards of care - a single instance of negligence - represents a significant departure from both the present regulation and the Board's governing statute, both of which currently require repeated occasions of negligence to justify even a complaint.

As at least one commentator has pointed out, the only sure way to avoid arbitrary or selective enforcement of the revised provision would be to impose discipline uniformly in each and every case of malpractice.

Establishing the violation of a Board policy as a ground for discipline is equally troubling. Unlike the Board's regulations, its policies are not promulgated through any public process and do not have the force of law. Rather, they are simply created by Board fiat - without any notice requirement - and therefore do not necessarily reflect well known or well understood standards of conduct in the medical profession.

Finally, imposing discipline for failing to comply with a subpoena (as opposed to failing to respond to a subpoena) can only have a chilling effect on physicians' willingness to assert legitimate and serious objections to overly broad Board subpoenas (e.g., peer review privilege).

This is especially concerning because another section of the proposed regulations eliminates judicial oversight in the enforcement of Board subpoenas. Currently, motions to quash, modify or vacate subpoenas are brought before a Superior Court judge.

However, under the Board's proposal, such motions would, in the future, be adjudicated by the Board's chair (who happens to be the same person who issued the subpoena).

One-way access to information

In addition to enhancing its subpoena powers, the current proposed regulations also increase the Board's ability to access information in other ways. Indeed, under the pending proposal, the Board could simply demand that a licensee provide it access to "any and all information that [the Board] deems necessary."

As you might have guessed, the refusal to comply with such a request is one of the newly enumerated grounds for discipline. The pending proposal also includes newly created authority to compel production of patient records - both from physicians and institutions - even without patient releases.

In fact, licensees could be compelled to make an "immediate" production of such records, without giving a patient a chance to even assert her confidentiality rights.

Unfortunately, the information exchange highway that the Board proposes moves only in one direction.

As currently drafted, a Board prosecutor would have total discretion to decide what, if any, information is provided to a physician's lawyer during an investigation. Indeed, the Board need not provide the licensee a copy of the complaint; under the proposed regulations, a description of the complaint will suffice.

Concerns have also been expressed regarding the proposed revisions to the Board's summary suspension authority. If adopted, the new regulations would permit the Board to suspend a license - without any notice or opportunity to be heard - if the Board perceives a "serious" threat to the public health.

Again, that reflects a departure from current practice, which allows licensees three days to provide rebutting evidence, and which also limits the Board's summary authority to situations where the perceived threat is both serious and immediate. Also troubling is that under the revised process, a licensee may no longer be entitled to an immediate hearing on the necessity of such a summary suspension.

Going forward

These examples illustrate the stakes at play. As the introductory comments of MMS observe, "the proposed regulations are highly complex and are likely to stand for more than a decade. It is critical that the impacts of the various changes ... are thoroughly reviewed before they are adopted."

To its credit, the Board seems to have recognized the profession's stakeholder status. The tone of the informal information session on Nov. 30 was noticeably collegial and, by adding a second round of proposed regulations, the Board appears amenable to engaging in a substantively interactive process.

But we won't know for sure until early January, when the revised version of the proposed regulations is issued.

Let's hope it's not two strikes and you're out.

Paul Cirel is a partner at Dwyer & Collora in Boston and focuses his practice on the representation of health care professionals including individual physicians, corporate providers and group practices.

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