Welcome back to Diagnosis, a vertical that focuses on the crossroads of health care policy and politics.
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Florida Gov. Ron DeSantis is poised to get a ban on gender-affirming care for minors in place just as voters will decide whether to give him a second term in office.
The Boards of Medicine and Osteopathic Medicine are meeting this Friday in Orlando where they are expected to consider a draft rule on gender-affirming care that was crafted and approved last week by a joint rules committee.
That rule, which has drawn sharp criticism from LGBTQ advocates, would bar physicians from providing their patients under the age of 18 with hormone and puberty blockers unless they are taking part in an institutional independent review board clinical trial affiliated with a university.
The proposed rule is silent on what will happen to patients younger than 18 who are currently being treated with hormone blockers, though the board is expected to make accommodations for existing patients.
The two medical boards are acting at the request of State Surgeon General Joseph Ladapo, but it also comes as DeSantis has made his opposition to gender-affirming care a recurring point in campaign stump speeches.
The Governor did it again Wednesday during a late afternoon stop in Pasco County where DeSantis asserted it is wrong to give gender-affirming care to minors, contending gender dysphoria “will resolve itself” for many teenagers once they become adults.
He said the term “gender-affirming care” is “a euphemism to try to hide the grotesqueness of what they are doing.”
“If a 15-year-old can’t get a tattoo, is it really appropriate that they can have their body parts taken off?” DeSantis asked.
National medical organizations support gender-affirming care for adults and adolescents and those opposed to the proposed rules point out that surgery is rare. Supporters of procedures also say such care leads to lower rates of depression and suicide risk for transgender youth.
Florida has already moved ahead with a rule that bars Medicaid from reimbursing for gender-affirming care, a decision that sparked a legal challenge in federal court.
Florida Medicaid Director Tom Wallace released a report June 2 showing the standard medical care for gender dysphoria does not meet generally accepted medical standards and is experimental and investigational. The “findings” led the agency to pass a rule banning Medicaid from reimbursing providers for gender-affirming care. The rule is being challenged in federal court.
Meanwhile, Yale physician Meredithe McNamara joined six other scientists and a lawyer to review the June 2 report. McNamara was one of a handful of providers who testified before a joint legislative and rules committee last week.
“We are alarmed that Florida’s health care agency has adopted a purportedly scientific report that so blatantly violates the basic tenets of scientific inquiry. The report makes false statements and contains glaring errors regarding science, statistical methods and medicine. Ignoring established science and long-standing, authoritative clinical guidance, the report instead relies on biased and discredited sources, including purported ‘expert’ reports that carry no scientific weight due to lack of expertise and bias,” the group wrote. “So repeated and fundamental are the errors in the June 2 Report that it seems clear that the report is not a serious scientific analysis but, rather, a document crafted to serve a political agenda.”
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— From defense to offense —
Tallahassee physician Dr. Joseph Dorn has been on the winning side of a legal tussle with state health care regulators who have tried to temporarily rescind his license, fine him and ban him from ordering medical marijuana for patients.
And now he wants the state to fork over hundreds of thousands of dollars to cover legal fees he incurred defending his license.
Dorn’s attorney, Ryan Andrews, filed a motion asking for a determination that Dorn is entitled to an award of reasonable attorneys’ fees and costs incurred and that a hearing is held to decide the proper amount of fees and costs.
According to the motion, Dorn had, as of Nov. 2, “incurred a total of $316.613.08 in attorneys’ fees and costs in connection with this action.”
Dorn also is contemplating suing the Department of Health (DOH) and/or some of its employees and former employees for negligence, fraud, civil conspiracy and tortious interference.
In addition to sending a notice to the DOH, Dorn’s attorneys have sent notice to former DOH General Counsel Louise St. Laurent; Office of Medical Marijuana Use Director Chris Ferguson; Medical Quality Assurance Chief Andre Moore; and Brent Johnson and Ben Lanier, the two investigators who posed as patients with post-traumatic stress disorder seeking care.
“This claim against DOH and others is predicated on the negligence of DOH, including specifically the negligent training and negligent supervision of its employees in connection with its actions against Dr. Dorn as outlined in the attached documents,” the legal notice reads.
— Back to the beginning —
One of the first physicians to be qualified to certify patients for medical marijuana, Dorn’s most recent legal victory comes in the form of a 15-page recommended order issued by state administrative Judge W. David Watkins.
Though Watkins in March issued a recommended order for the DOH to dismiss its administrative complaint against Dorn, the Florida Board of Medicine (BOM) took exception to the recommended order at its June meeting.
Members of the BOM voted to remand the recommended order back to Watkins alleging the judge failed to issue “findings of fact” on three specific issues: whether Dorn performed a physical examination on patients; checked the prescription drug monitoring program for the patients; and/or engaged in a trick or scheme by charging 3,000 new patients $299 for a medical marijuana certification without having any necessary medical equipment in his office.
To that end, Watkins issued a 15-page supplemental findings of fact Oct. 22 making clear Dorn’s time and exchanges with the patients amounted to a physical examination and that the Board of Medicine has not provided a definition of a physical examination in its rules.
“The Department argues that the term ‘physical examination’ is not confusing or ambiguous. The competent substantial evidence of record does not support this claim. Indeed, at (the) hearing, no Department witness articulated the specific components of the physical exam that it contends Dr. Dorn failed to perform. Had the term been as clear and unambiguous as the Department contends, then one of its witnesses certainly could have specified the required components of the exam. This it did not do.”
Moreover, in the supplemental findings of fact, Watkins argued the DOH’s position that Dorn was required to physically examine patients who suffer from PTSD by taking vital signs or otherwise laying hands on the patient, is “not supported by the persuasive evidence of record.”
Watkins wrote that Dorn’s “visual physical examination of the two “patients,” in conjunction with his review of the patient intake forms, review of the available medical records and face-to-face interview, satisfied Dr. Dorn’s obligation to conduct a physical examination of the two patients.”
The department alleged Dorn did not have the necessary medical equipment in his office to conduct the appropriate physical examinations that are required by statute. The department also stated that charging each new patient $299 to get registered in the medical marijuana use registry was an abuse of his authorization as a qualifying physician and that he registered more than 3,000 patients in a year.
But in his Oct. 22 supplemental findings of facts, Watkins said there was no evidence presented during the hearing that supported the department’s argument about lack of equipment or the $299 charges. Additionally, Watkins noted in the ruling the department did not make an issue of Dorn’s patient load during the administrative hearing.
“DOH also conceded that Dr. Dorn was not the top prescriber of medical marijuana in Florida for that same time period,” Watkins wrote. “Assuming normal working hours and that Dr. Dorn took a two-week vacation during the period at issue, he would still have had the ability to see 4,000 patients, each with a 30-minute appointment. There is nothing in this record to suggest that there was anything inappropriate in the sheer volume of medical marijuana certifications issued by Dr. Dorn.”
According to a Board of Medicine transcript, board members briefly discussed whether it should take exceptions with three other portions of the March recommended order but decided against it.
Watkins said he reviewed the transcript and, “in order to avoid another remand from the board,” he addressed the three outstanding provisions finding that the DOH failed to establish by clear and convincing evidence that Dorn’s physical examination failed to meet the requirements in the medical marijuana law or that Dorn made deceptive, untrue, or fraudulent representations in or related to the practice of medicine or employing a trick or scheme in the practice of medicine.
The BOM will review Watkins’ supplemental findings of facts and decide whether to accept the recommendations or appeal them to the 1st District Court of Appeal.
— Court: Hospital staff texts not private —
Noting there is no absolute right to privacy, a Tallahassee appeals court refused to intervene in a medical malpractice case in which hospital employees were ordered to turn over copies of text messages to the former patients of a surgeon they worked with.
A three-member panel of the 1st District Court of Appeal denied a request from seven employees at Ascension St. Vincent’s for the appellate court to take jurisdiction in the lawsuit filed by scores of former patients and orthopedic surgeon R. David Heekin.
Writing for the three-member panel, Judge Thomas Winokur noted the state constitution does provide protections and the Florida Supreme Court has determined the privacy clause in the constitution applies to “informational privacy.”
“However, the Supreme Court has also held that our state constitution’s privacy right is not absolute … recognizing that Florida’s right to privacy ‘was not intended to be a guarantee against all intrusion into the life of an individual,” Winokur wrote in an opinion that was agreed to by Judges Timothy Osterhaus and Judge Robert Long Jr.
Heekin, who is suffering from a progressive neurological condition that caused him to lose his balance and slur his speech, is being accused of botching surgeries, according to Jacksonville media following the case.
The patients allege Heekin and Ascension St. Vincent’s knew or should have known he was unfit to practice medicine but allowed him to continue anyway.
The patients filed suit in Jacksonville and sought to obtain text messages with observations about Heekin’s purported behavior from the seven hospital employees.
Under Florida’s broad discovery rules, any non-privileged information, including electronically stored information such as text messages, is discoverable so long as it is relevant to the subject matter of the action.
The seven hospital employees sought a protective order, arguing the state constitution provides them a global right to privacy, which includes the text messages sent from and received by their personal phones. They also argued producing the information would constitute an undue burden and cost.
The trial court ruled the text messages were generally discoverable. The judge then directed the employees to compile privacy and privilege logs containing the individual text messages they intended to argue should be excluded.
The employees subsequently submitted a privacy log withholding thousands of pages of text messages and images that were identified as “private conversations on personal cellular phones re: Heekin.” They also filed a privilege log that identified around 20 text messages they alleged were subject to various other privileges and protections.
After submitting the logs, the employees filed a motion in circuit court for a protective order, again arguing the state constitution protects their right to privacy. The motion also requests that the text messages, if ordered to be produced, be treated as confidential and filed under seal.
The circuit court judge denied the employees’ petitions and opined that producing the information wouldn’t be an undue burden or cost because St. Vincent’s Medical Center was paying the costs.
The employees appealed the rulings to 1DCA in Tallahassee, filing for a “writ of certiorari” review that, if approved, would have allowed the appellate court to take jurisdiction of the case.
Considered an extraordinary step, to grant the request, the petitioner must prove that the judge’s discovery order departed from the essential requirements of the law and that the impending result caused a material injury for the rest of the case that cannot be remedied on direct appeal.
“Under the particular facts of this case, (St. Vincent’s Medical Center employees) have failed to show that they have a clearly established global right to privacy in personal text messages that is sufficient to outweigh the tailored need for discovery. Certiorari review should not be used to create new law where the law at issue is not clearly established,” the opinion notes. “No Florida court has ever recognized an absolute right to privacy in text messages.”
— Looking for answers —
Florida Republicans are pushing the Biden administration for an update on the state’s proposal to create a Canadian Prescription Drug Importation Program.
U.S. Sen. Marco Rubio and U.S. Reps. Mario Díaz Balart, John Rutherford, Gus Bilirakis, Neal Dunn, and Brian Mast sent a letter to Food and Drug Administration Commissioner Robert Califf requesting an update on the state’s Section 804 Importation Program (SIP) application Florida sent to the federal government in 2020.
“It has been more than 700 days since AHCA submitted their proposal, yet the state has received no update or timeline from the FDA on the latest SIP proposal. As such, we ask for an update on Florida’s SIP application and that the FDA work with Gov. DeSantis to expeditiously approve Florida’s proposal to safely import certain prescription drugs from Canada,” the letter reads.
AHCA allegedly has been reaching out to the FDA for months to get an update on the status of the application but to no avail.
“This situation is particularly frustrating as information has come to light that the FDA is actively working with other states on developing their SIP proposals while Florida’s program remains stalled,” the letter reads, noting that Florida was the first state to submit a SIP application.
DeSantis made the creation of a drug-importation program a top health care priority since taking office in January 2019. He worked closely with former House Speaker Jose Oliva on the proposal, HB 19.
— Florida’s opioid settlements —
This week, two of the nation’s largest pharmacy owners, CVS Health and Walgreens Boots Alliance, announced they had agreed to pay $10 billion to settle lawsuits filed by states and cities, and others over the opioid crisis.
Florida wasn’t part of that litigation. That’s because Attorney General Ashley Moody and her office already have reached their own settlements with 12 separate defendants, including the two drugstore chains and Walmart.
The state’s legal foray into the opioid crisis started more than four years ago when then-Attorney General Pam Bondi filed a lawsuit against drug manufacturers and distributors in May 2018. Bondi left office in early 2019 and Moody picked up the battle and expanded the list of defendants.
Just as important, Moody, weathering significant pushback behind the scenes, was able to win a big legislative victory in her first year in office that aided her effort. She convinced the Florida Legislature to pass a bill that gave her permission to access the state’s prescription drug monitoring program database. That gave the state the ability to obtain information that it could use in its lawsuits.
At one point it appeared the legislation was going to stall over privacy concerns but passed both chambers unanimously.
“The destruction caused by opioid abuse is undeniable and this epidemic is ravaging our communities. Those who helped fuel this man-made crisis must be held accountable and this new law will help us do that,” Moody said at the time the bill passed.
Fast forward and the state now has managed to reach settlements totaling more than $3.2 billion, including one in March with CVS Health worth $440 million and one in May with Walgreens worth more than $680 million. Much of the money won in the settlements will go toward opioid abatement efforts, including for cities and counties.
— LOBBYISTS —
Here’s a rundown of lobbyist registrations between Oct. 23 and Nov. 3:
— Roger Fitzgerald Harris has registered to lobby for AARP
— Rebekah Hurd had registered to lobby for Advent Health
— Jason Weida has registered to lobby for the State Agency for Health Care Administration
— Jason Maine has registered to lobby for Angels of Care Pediatric Home Health and Team Select Home Care
— Christopher Berg has registered to lobby for Camelot Community Care
— Caleb Hawkes has registered to lobby for Florida Coalition for Children
— ROSTER —
— Carol Mathews, M.D., an internationally known clinician and translational researcher in the areas of obsessive-compulsive disorder, tic disorders and anxiety disorders, has been named chair of the UF College of Medicine’s department of psychiatry.
— Michael Gallo, M.D., joins Baptist Health as a sleep medicine physician with the cardiology team after completing his fellowship at the University of Michigan in Ann Arbor, Michigan.
— Alexander Greenwood, MBA, has been appointed as the new Chief Operating Officer for Cleveland Clinic Indian River Hospital. Greenwood joins Cleveland Clinic Indian River Hospital from Lee Health in Fort Myers, where he served in various leadership roles during his 16-year tenure.
— Michelle Canale was sworn in as president of the Florida Association of Nurse Anesthesiology at the group’s recent annual meeting in Clearwater. Karla Maldonado, DrAP, CRNA, APRN, was sworn in as serve as president-elect; and Jorge Valdes, DNP, CRNA, APRN, FAANA, was sworn in as secretary/treasurer.
— ETC —
— Heather Flynn, professor and chair of the Department of Behavioral Science and Social Medicine at the Florida State University College of Medicine, has co-authored an article in the “Substance Use and Misuse Journal” analyzing self-reported responses from more than 2,000 patients enrolled in Florida’s medical marijuana program. The finding of the self-report responses, according to the university, show that more than three-quarters said they eliminated or significantly reduced their opioid use after beginning cannabis treatment.
— A research team at the University of Miami Miller School of Medicine, led by Claude-Henry Volmar, Ph.D., and Claes Wahlestedt, M.D., Ph.D., has received a $1.86 million National Institutes of Health/National Institute on Aging (NIH/NIA) grant to study how menopause generates DNA damage and whether that increases a woman’s risks of developing Alzheimer’s disease. The ultimate goal is to identify biomarkers that could detect increased Alzheimer’s risk at an early age.
— The University of Central Florida has been accepted into the Consortium of Universities for Global Health (CUGH), an organization of 170 academic institutions and organizations worldwide that are committed to addressing global health challenges, according to the UCF College of Medicine.
— ICYMI —
In case you missed them, here is a recap of other critical health care policy stories covered in Florida Politics this past week.
— Going for gold: Members of a blue-ribbon, long-term care panel agreed to schedule on-site visits to six nursing homes and to reconvene at the end of November to decide which facilities should be recommended for the “Gold Seal” designation. “The Gold Seal to me is a very precious Governor’s panel as we are reviewing the best of the best in long-term care in Florida,” Governor’s Panel on Excellence in Long-Term Care Chair Bobby Rosenthal said.
— Growing like a weed: Florida’s medical marijuana market continues to grow as more and more residents qualify for access. Not only has the number of patients qualifying for medical marijuana increased in the last year, but daily dose amounts ordered have also, according to the Physician Certification Pattern Review 2023 Annual Report, which shows 546 million ounces of smokable marijuana was certified for patients between July 1, 2021, and June 30, 2022.
— Telling data: Nearly $1 billion was paid last year to close out nearly 3,000 medical malpractice claims leveled against health providers in Florida, a newly released report from state regulators shows. The report, prepared by the Office of Insurance Regulation (OIR), showed that about one-third of those claims were filed because of patients who had died.
— In with the new: The Florida Association of Community Health Centers has selected Jonathan Chapman as its next president and CEO, effective Dec. 1. In his new role, Chapman will work to further FACHC’s mission of safeguarding the stability of the state’s Community Health Centers and ensuring equitable access to primary care for all Floridians.
— TGH named Center of Excellence in Robot-Assisted Surgery: The surgeons at Tampa General Hospital recently performed the 10,000th robot-assisted surgery using the da Vinci Surgical System. This surgical milestone earned the academic medical center accreditation as a Center of Excellence in Robot-Assisted Surgery from the Surgical Review Corporation (SRC).
— FOR YOUR RADAR —
Aside from coverage by Florida Politics, these stories are worth your time.
—“Strike at health care call centers marred opening day of ACA enrollment,” via Cindy Krischer Goodman of the South Florida Sun-Sentinel — Floridians became eligible to enroll in Affordable Care Act health insurance coverage starting Tuesday, just as workers at some of the largest call centers went on strike. The target of the one-day protest was Maximus, a federal contractor that operates 10 call centers handling enrollment for Medicare and the ACA’s federal marketplace. Two are in Florida, in Tampa and Lynn Haven.
—“BayCare names new president for St. Joseph’s Hospital in Tampa,” via Christopher O’Donnell of the Tampa Bay Times — BayCare Health System on Monday named Nate Malcolm the new president of St. Joseph’s Hospital, the nonprofit’s largest Hillsborough County facility. Malcolm’s tenure took effect immediately. He previously worked as a vice president of operations for Advocate Aurora Health and has two decades of hospital leadership experience, according to BayCare. His tenure in Chicago included the management of three hospitals with Level 1 trauma centers totaling 1,300 beds, a Level 3 neonatal intensive care unit, and a comprehensive stroke center. He will replace Kimberly Guy, who in addition to leading St. Joseph’s is already serving as senior vice president and market leader for BayCare’s Hillsborough County hospitals.
— “Florida’s seniors lead nation in COVID-19 deaths since April 2021; population can’t explain it,” via Chris Persaud of the Palm Beach Post — As far as Joanne Tinsley is concerned, her 87-year-old father, Raymond Barber, did not have to die of COVID-19. A retired engineer, he regularly wrote code on his computer at a nursing home where he lived in Poinciana, about halfway between Orlando and Lakeland, Tinsley said. Then in December 2021 he fell ill and had to be hospitalized. After he left the hospital, she said, he was put in a crowded rehabilitation facility to recover in St. Cloud, where he developed a cough and tested positive for respiratory disease. He was triple vaccinated but didn’t make it. On Feb. 15, Barber became one of tens of thousands of elderly Floridians whose lives were cut short by COVID-19.
— “Six months later, UnitedHealthcare members regain in-network access to Broward Health,” via Ron Hurtibise of the South Florida Sun-Sentinel — Six months after forcing members to seek care with other providers, Broward Health and UnitedHealthcare have announced a new long-term contract. The contract reinstates in-network access to Broward Health’s hospitals, facilities and physicians, according to a joint news release from the two entities Monday. The new agreement, which affects enrollees in UnitedHealthcare’s employer-sponsored, individual, Medicare Advantage and Medicaid plans, went into effect Tuesday.
— “Will a winter COVID-19 surge hit Florida? Researchers are using artificial intelligence to figure it out,” via Cindy Krischer Goodman of the South Florida Sun-Sentinel — Now, Florida researchers believe they can get ahead of COVID waves by building an algorithm to spot new variants of concern before they spread. “Imagine if we could get ahead of the curve,” said Marco Salemi, a professor of experimental pathology at the University of Florida. “Using artificial intelligence, we can learn patterns from a massive amount of data that are not easily distinguishable to the human observer.” The researchers are taking publicly available information from a global database where scientists upload the sequences of the COVID virus from positive test samples. Their goal is to design an algorithm — a set of computerized instructions or rules — that would comb the data and find new variants that pose a threat.
— PENCIL IT IN —
Thursday
2 p.m. AHCA holds a public meeting on proposed Rule 9A-8.0248 that will outline guidelines for the Excellence in Home Health award designation. Place: 2727 Mahan Drive, Building 3, Conference Room C, Tallahassee. Or call (888) 585-9008; participant code: 998518088#.
3 p.m. AHCA hosts a public meeting on proposed Rule 59A-18.0145 which outlines the guidelines for the Nurse Registry Excellence Program award designation. Place: 2727 Mahan Drive, Building 3, Conference Room C, Tallahassee. Or call (888) 585-9008; participant code: 998518088#.
Friday
Happy birthday to Rep. Demi Busatta Cabrera.
Happy birthday to Rep. Felicia Simone Robinson.
2 p.m. The Florida Board of Medicine and the Florida Board of Osteopathic Medicine meet in Orlando to discuss a proposed rule on gender-affirming health care. Place: 1805 Hotel Plaza Boulevard Lake Buena Vista. Agenda here.
Tuesday
Election Day
9 a.m. Health Information Exchange Coordinating Committee (HIECC) meets via webinar. Email Crystal Ritter at [email protected] for more information.