Three months after the state medical board voted to tighten regulations on how doctors practice medicine, the rules are facing stiff resistance from Massachusetts hospitals and physicians, and it’s unclear to what extent they are being obeyed.
The regulations, which medical experts describe as among the most-far reaching in the country, require doctors to provide more information to patients who are considering surgery and to document each time a lead surgeon enters and leaves the operating room. They also take a hard line on doctors who come to work impaired by alcohol or drugs and who delegate duties to unlicensed practitioners.
The board approved the regulations in a 4-0 vote on July 17, and they took effect Aug. 9. But lobbyists for hospitals and doctors have urged the agency and Governor Charlie Baker’s administration to shelve or clarify them, saying the board rammed through confusing and burdensome requirements.
Although hospitals want to comply, “many practical concerns remain, and the non-transparent nature of the process leading to these regulations is highly problematic,” the Massachusetts Health & Hospital Association said in an e-mail to the Globe.
The association and the Massachusetts Medical Society, which represents 25,000 doctors and medical students, are especially upset about a requirement that doctors disclose who will participate in surgeries prior to obtaining written consent from patients. On Sept. 20, the two lobbying groups urged the board to delay the effective date of all the rules for a year.
The board’s executive director, George Zachos, rejected that request in a letter to the groups Friday but offered to meet with the lobbyists, saying “our lines of communication are open.”
Dr. Candace Lapidus Sloane, a pediatric dermatologist who chairs the medical board, was more blunt.
“These regulatory enhancements have been in development for three years,” she said in an interview. “I struggle to understand the motivation for second-guessing these regulatory enhancements at this late stage.” To put them on hold, she added, “makes no sense.”
Although the rules address a variety of concerns, they were largely galvanized by heightened scrutiny of surgeons who perform more than one operation at a time.
A Globe Spotlight Team series in 2015 found that disputes over surgeons running multiple operating rooms simultaneously had erupted at several teaching hospitals across the country, including Massachusetts General Hospital in Boston.
A bitter disagreement about the practice among a handful of orthopedic surgeons at Mass. General led to the dismissal that year of the hospital’s leading critic of so-called double-booking. The dispute also prompted a federal whistle-blower lawsuit by a former MGH anesthesiologist and a wrongful-termination lawsuit by the vocal critic, a surgeon who was fired.
Defenders of concurrent surgery say it enables doctors in high demand to perform key parts of surgeries on more patients and to delegate more-routine aspects to surgeons in training. Critics counter that the practice is dangerous and that surgeons rarely, if ever, inform patients that they will be sharing their surgeon.
Among the cases featured in the Spotlight Team series was a 2011 spine operation at Mass. General on Boston Red Sox pitcher Bobby Jenks. In May of this year he settled a lawsuit against the hospital and his spine surgeon for $5.1 million, alleging that Jenks suffered a career-ending injury because his doctor was overseeing a second simultaneous operation.
In response to such cases, the medical board in January 2016 overwhelmingly gave preliminary approval to requirements that surgeons document each time they enter and leave the operating room, as nurses sometimes do; identify junior surgeons and other medical staffers who will assist in operations before patients consent to surgery; and obtain the patient’s consent in writing. The proposed changes then went to the state Executive Office of Health and Human Services for review, where they appeared to languish.
In the meantime, several groups, including the medical society and the Conference of Boston Teaching Hospitals, criticized the proposed revisions as confusing and impractical at a public hearing and in written submissions.
In July, Health and Human Services referred the proposals back to the board, which approved them without debate. The goal of the new rules on surgery, Sloane said at the time, was “to ensure that patients have knowledge about who’s going to be operating on them.”
A spokesman for the Federation of State Medical Boards, which represents the nation’s 70 state medical and osteopathic regulatory boards, said afterward that it was unaware of other states with similar surgical rules. The federation has invited board officials to speak in a webinar next month so other states can consider whether to follow suit.
Soon after the rules won final approval, representatives of hospitals and doctors began complaining to the board and state officials, according to e-mails recently obtained by the Globe.
“We’re getting pummeled here — physicians have no idea what to do with these regs,” Brendan Abel, the medical society’s legislative counsel, wrote on Aug. 15 to a state health official. “The sloppiness of these regs is becoming more apparent by the day.”
The hospital association, in its e-mail Monday to the Globe, contended that the board hastily approved rules “without sufficient notice to stakeholders and without all of the voting members present.” Three of the board’s seven members were absent.
But Sloane denied that the board acted in haste.
“Drafts were circulated, years ago, to all parties, and hearings were held and the regulations were approved by all levels of state government,” she said in an interview.
Dr. George Abraham, another board member who voted for the new rules, said a draft of the proposed revisions was on the board’s website for two years.
Critics have aimed much of their fire at the new surgical rules.
Dr. Thomas Sequist, chief quality and safety officer at Partners HealthCare, the state’s largest health system, wrote Abel on Aug. 20 complaining that it was unclear whether the rules required patients to give written consent to minor procedures, such as the removal of a wart or a Pap smear.
He also complained that patients often agree to operations a few weeks beforehand and that surgeons don’t know which residents and fellows will participate until shortly before the operation.
To clarify the rules, the medical board issued seven pages of “frequently asked questions.”
The document said the new regulations don’t change the type of procedures that need a patient’s informed consent; if a minor procedure didn’t require it before, it still doesn’t. The only difference, said the board, is that if doctors need to get informed consent, they must provide more information about who will be participating in the surgery, and it must be in writing.
As for identifying members of the surgical team, the board said that if a surgeon doesn’t know who else will participate, he or she can at least tell the patient that a resident will likely be on the team and how many years of training that doctor is expected to have. After the operation, the surgeon can update the medical record to include the junior surgeon’s name.
Coincidentally, Sloane said, her 20-year-old son underwent surgery at Mass. General Wednesday to repair his broken nose and received all the information required by the new rules before he gave written consent. “It took less than a minute,” she said.
Nonetheless, some critics said the rules should be shelved.
“I don’t think a hundred FAQs could fix things,” Abel, of the medical society, wrote on Aug. 15 to Leslie Darcy, chief of staff for Health and Human Services.
A spokeswoman for MaryLou Sudders, secretary of Health and Human Services, said the medical board considered the concerns of critics before voting. Her agency can “provide feedback,” the statement said, but the board makes “the final decision.”
A spokesman for Boston Medical Center said the hospital was “actively working on implementing the new regulations” but had concerns about “unintended consequences.” Partners HealthCare, which includes MGH and Brigham and Women’s Hospital, and Beth Israel Deaconess Medical Center, referred questions to the hospital association.
The association said it’s the “collective intent of the hospital community to comply” with the rules but many problems remain.
Jonathan Saltzman can be reached at firstname.lastname@example.org