Diagnosis for 1.3.23: Checking the pulse of Florida health care news and policy

Welcome back to Diagnosis, a vertical that focuses on the crossroads of health care policy and politics.

— So Ladapo —

State Surgeon General Joseph Ladapo on Wednesday called for the halt in the use of COVID-19 mRNA vaccines and told health care providers they should seek out non-mRNA vaccines and treatment for patients they deem to have COVID-related health risks.

His boss, Gov. Ron DeSantis, supported the statement on the campaign trail in Iowa saying “There’s huge issues with it. They haven’t been with the public on it.” DeSantis added that the Food and Drug Administration is “basically a rubber stamp for the pharmaceutical industry.”

Ladapo issued the statement following an exchange he had with the FDA as to whether the government followed regulatory limits for DNA vaccines in the Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications.

Ladapo sent the FDA a letter in early December citing an Oct. 19 analysis of 27 mRNA vials of Pfizer and Moderna that showed the presence of billions to hundreds of billions of DNA molecules per dose. The 2023 report also included an “exploratory analysis” of the relationship between the residual DNA content and serious adverse conditions reported to the Vaccine Adverse Event Reporting System. Though the sample size was limited, the authors conclude the findings warrant further examination.

Ladapo said in a prepared release that the FDA did not provide evidence that it adhered to its own policies on DNA integration into human DNA. He also accused the government of “obfuscating” scientific facts in its response, sent just eight days after Ladapo’s inquiry.

“DNA integration poses a unique and elevated risk to human health and to the integrity of the human genome, including the risk that DNA integrated into sperm or egg, gametes could be passed onto offspring of mRNA COVID-19 vaccine recipients. If the risks of DNA integration have not been assessed for mRNA COVID-19 vaccines, these vaccines are not appropriate for use in human beings,” he said.

Worth noting: the 2023 analysis Ladapo cited in his letter was conducted on vaccines from Ontario, Canada.

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— Canadian Drugs —

Speaking of Canadian drugs, Agency for Health Care Administration Secretary Jason Weida said the state expects to hear by Friday whether its plan to import cheaper prescription drugs from Canada will be approved.

Weida told members of a House health care spending panel that he was “cautiously optimistic” that the FDA would approve the plan.

“They have set up a number of hoops. We have jumped through them all,” he said.

The DeSantis administration submitted its proposal for approval in November 2020, while former President Donald Trump was still in office.

The DeSantis administration has filed a trio of lawsuits around the request, one accusing the government of illegally slowing down the decision, and two others alleging violations of the Freedom of Information Act stemming from unfulfilled public records requests the state made to the FDA.

With no success on the Canadian Drug importation program front, DeSantis in 2023 made regulating pharmacy benefit managers (PBMs) — which negotiate the costs of drugs with pharmaceutical manufacturers — a top priority.

— Is Florida next? —

Florida is one of 11 states that currently doesn’t participate in an interstate compact or licensing agreement to streamline the licensing process for physicians who want to practice in multiple states.

But Senate President Kathleen Passidomo wants to change that and included in her ambitious Live Healthy plan is a provision that would lay the groundwork for Florida to participate in the agreement, officially known as the Interstate Medical Licensure Compact, or IMLC, to help bolster the state’s physician workforce.

The 2023 Physician Workforce Annual Report prepared by the Department of Health shows that more than 98% of the physicians work in urban counties while the remainder work in one of 31 rural counties.

Interest in IMLC licensing has grown exponentially since its inception in April 2017 when the IMLC Commission processed 125 licensure applications in its first eight months of operations. Six years later, the Commission processed 19,147 applications.

A recently released report conducted by the IMLC Commission shows that in calendar year 2022 over 17% of all the new licenses obtained by physicians in the United States were through the IMLC process and over 31% of the new licenses issued by member-participating states were through the IMLC process

Moreover, according to Marschall Smith, the executive director of the IMLCC, which regulates the terms of the compacts, more than 35% of the licenses obtained are used by physicians in rural and underserved areas.

IMLC licensure is not inexpensive, though. According to the IMLC Commission website, the initial cost of IMLC licensure is $700. That cost is in addition to the licensure fees levied within the compact state where a physician wants to operate.

— Not universally loved  —

While some people like the IMLC approach, it’s not for everyone. And at least one naysayer is physician and state Rep. Joel Rudman.

Born and raised in Mississippi, Rudman, who practices in Navarre, graduated from the University of Mississippi with a medical degree in 1996. He completed his residency in Daytona Beach and says his Florida medical license is one of his “shining accomplishments.”

“I know doctors in Mississippi and there’s no doubt that the doctors in Florida are held to a higher standard. It’s because we practice under a microscope. We have people looking over our shoulders — for better or for worse — just given the nature of Florida’s system. In other words, Florida’s a little bit more litigious. Florida doesn’t let things go as easily as perhaps a state like Mississippi or Alabama,” Rudman told Florida Politics.

“I can tell you that during my residency in Florida, we crossed our T’s and dotted our I’s. We were very, very careful to watch each and everything we did. And I can tell you, I don’t think you have that level of scrutiny in other states.”

Instead of interstate medical compacts, Rudman says Florida should focus on ways of keeping Florida-trained physicians working in Florida.

“We are good at recruiting the very best and most capable physicians to the state my advice would be let’s try like hell to retain them in the state,” he said, plugging HB 11, a proposal that would amend the state’s commerce and trade laws to make clear that contracts with no-compete clauses that prevent medical doctors and osteopathic physicians who leave their employment from practicing in certain geographic areas do not serve a legitimate business interest and are not enforceable.

There have been 50 lobbyist registrations on the proposal. The Senate counterpart, SB 458 has drawn 20 lobbyist registrations to date.

“I think we have plenty of doctors in training in Florida. Let’s do whatever we need to keep them here,” he said.

— Hearing set —

The Florida Supreme Court will hold oral arguments next month on whether an abortion rights amendment should be allowed on the 2024 ballot.

The court announced this week that it had signed off on holding a Feb. 7 hearing on the measure that would ban Florida legislators from restricting abortion before about 24 weeks of pregnancy.

Organizers backing the amendment are close to gathering enough signatures to qualify for the ballot, but the court is required to review citizen initiatives to make sure they are not misleading and stick to a single subject.

Attorney General Ashley Moody wants the court to block the measure from the ballot. She and her attorneys have maintained that the abortion rights amendment could confuse voters because it bans abortion restrictions before viability. Supporters of the amendment contend Moody is opposing the measure for political reasons and that she is “distorting” the language.

Floridians Protecting Freedom, the group pushing the proposed amendment, has had nearly 864,000 voter signatures verified by election officials. The group must have more than 891,000 valid signatures by Feb. 1 to qualify for the ballot. The abortion rights initiative must be approved by 60% of voters to pass.

— RULES  —

AHCA issued a correction to its Rule 59A-8.0099 on home health aides and musically fragile children. More here. It’s holding a workshop on the proposed rule Thursday, Jan. 11 at AHCA’s headquarters at 2 p.m. More here.

— LOBBYISTS —

Sara Clements, Rhett O’Doski, Sean Stafford, McGuireWoods Consulting: ShiftMed

Lenny Curry, Jordan Elsbury, Ballard Partners: North Florida Medical Center

Kaley Flynn, Capital City Consulting: Community Care Plan

— ETC —

— AHCA is expected to post ITN Dental Respondent Names on Monday. The posting of the information allows dentists to submit to the state any experiences they have had with the companies under consideration for a state contract.

— AHCA approved PruittHealth’s request to transfer its certificate need for a 119-bed nursing home from Brandon to a different facility in Hillsborough County. More here.

— Memorial Healthcare System in Broward County and Cigna have struck an agreement that allows the physicians to remain “in-network” for its commercial products. The new agreement took effect Jan. 1.

— Kristin A. Heath, DBA, MBA, MHA has been appointed as executive director of the UF Health Proton Therapy Institute. Heath joins the Institute from the Miami Cancer Institute at Baptist Health South Florida where she has led as director of operations, radiation oncology since 2019. The UF Health Proton Therapy Institute is a nonprofit 501(c) 3 organization affiliated with the UF College of Medicine and the UF Health Cancer Center, a Florida Cancer Center of Excellence and an NCI-Designated Cancer Center.

— ROSTER —

— Six Florida hospital executives made a list of 60 hospital and health system chief marketing officers to know in 2023 published by Becker’s Hospital Review. Those making the list are Melanie Husk, senior vice president and chief consumer officer of Baptist Health Jacksonville; Stacey Brandt, executive vice president and chief administrative officer at Tampa General Hospital; Sharon Line Clary, vice president of strategic marketing and communications at AdventHealth Central Florida in Orlando; Christine Kotler, vice president and chief marketing and communications officer at Baptist Health South Florida in Miami; Matthew Pinzur, senior vice president and chief marketing officer at Jackson Health System in Miami; and Andrew Snyder, senior vice president of marketing and communications at Orlando Health.

— Jordan Fulkerson was named Chief Financial Officer of HCA Florida Citrus Hospital. He previously served as the CFO of HCA Florida St. Petersburg Hospital.

— DeSantis appointed made seven appointments to the Florida Trauma System Advisory Council this week. Peter Powers at Memorial Healthcare System, Jennifer Sweeney at Sarasota Memorial Hospital and Dr. Tracy Zito at Orlando Health work at health systems that are members of the Safety Net Hospital Alliance of Florida (SNHAF).

— Justin Senior, CEO of the SNHAF, and Lindy Kennedy, chief operations officer for the association, released a joint statement calling the appointees game changers. and said the appointments are game-changing. “These systems have some of the leading trauma research, equipment, and personnel in the world.”

— Those aren’t the only hospital representatives on the advisory council. DeSantis appointed Dr. Darwin Ang, trauma medical Director at HCA Florida Ocala and a professor of surgery and a program director of general surgery residency at the University of Central Florida; Dr. Mark McKenney, chief of trauma surgery and program director for the general surgery program at HCA Florida Kendall Hospital; Madonna Stotsenburg, director of trauma and emergency services at St. Mary’s Medical Center to the council also. The governor also appointed Dr. Angus Jameson, Florida’s emergency medical services medical director and former associate professor of emergency medicine at the University of South Florida.

— ICYMI —

In case you missed them, here is a recap of other critical health care policy stories covered in Florida Politics this past week.

Shhhh: The DeSantis administration quietly announced last week its plans to comply with new Medicaid policies to extend health care coverage to poor and low-income children and to ensure federally approved vaccines are covered. State Medicaid officials announced on Dec. 26 that they were sending the amendments to the Centers for Medicare & Medicaid Services (CMS) for approval. One amendment ensures that effective Jan. 1, children under 19 years old who qualify for Medicaid will have coverage for 12 months without having to take steps to requalify for the safety net program. Before the change, Florida policy was to provide 12 months of Medicaid eligibility for children under 5 years old. Eligibility for older children (5 through 19) has been limited to six months.

Wish list: In Boca Raton Sen. Tina Polsky’s ambitious slate of bills for the coming 2024 Legislative Session, there’s no shortage of variety, from protections for public employees who use medical marijuana to easing property insurance claim resolutions. But of all the measures she’s carried into the New Year, three aimed at shoring up Florida’s shortage of mental health care specialists, providing clarity to re-enfranchised voters and expanding neonatal screenings take precedence. The first measure (SB 164) is Polsky’s No. 1 priority. It would simply add people seeking mental health counseling degrees to the Florida Reimbursement Assistance for Medical Education (FRAME) Program, a state scholarship initiative that currently benefits doctors, physician assistants and nurses.

Stop right there: The DeSantis administration is going to delay work on a $154 million information technology contract that is the central part of an overhaul of the state’s Medicaid management information system. The decision was made by the Florida Health Care Connections (FX) Executive Steering Committee. The body voted unanimously this week to halt for at least 12 months work on its contract with Gainwell Technologies LLC for “core” services and to complete work on two other IT-related contracts by December 2024.

FP Top 5 health care stories of 2023: Florida was at the center of ongoing debates and controversies dealing with health care in 2023, ranging from abortion restrictions to transgender health care to COVID-19. There were some honorable mentions that narrowly missed the cut such as AHCA releasing three Medicaid managed care ITNs, Florida’s ongoing physician shortage, and passage of a sweeping law regulating pharmacy benefit managers, or PBMs.

— FOR YOUR RADAR —

Aside from coverage by Florida Politics, these stories are worth your time.

“If ‘dry’ January sounds daunting, try ‘damp’ January instead” via Anahad O’Connor of The Washington Post — Every year thousands of people take part in the Dry January sobriety challenge to improve their health and regain control of their drinking. But if you can’t commit to a full month of abstinence, take heart: You don’t have to go cold turkey to improve your relationship with alcohol. A semi-dry ritual dubbed “Damp January” has become an annual event for people who want to cut back on alcohol without giving it up entirely. Studies show that even a modest reduction in drinking can lead to improvements in blood pressure, mental health and liver health. It can lower the risks of cancer and heart disease. You may even notice improvements in your sleep, energy levels and skin.

“Clinic billed Allstate millions for unnecessary, life-threatening surgeries, suit says” via Ron Hurtibise of the South Florida Sun-Sentinel — Allstate Insurance Company is accusing a Florida-based medical clinic of fraudulently performing unnecessary, life-threatening spinal surgeries and billing for surgeries not performed, then justifying them on invoices with falsified medical records. The defendant, Florida Anesthesiology & Pain Clinic, is accused of violating laws originally created to fight organized crime. The clinic has offices in six Florida locations. Allstate, in a lawsuit filed Thursday in U.S. District Court in West Palm Beach, accused the clinic and its owner, Dr. Ravi Xavier, of perpetrating an “insurance fraud scheme” designed to elicit payments from the insurer. The insurer says it paid millions of dollars to resolve insurance claims “that were based on the false, fabricated, unlawful, and improper medical services” described in the lawsuit.

“Florida is pulling out all stops to block voters from deciding on abortion” via the Miami Herald editorial board — The ballot measure is not a done deal yet. The state is trying to block voters from having their say. Attorney General Ashley Moody has filed a court challenge regarding the wording of the summary that would appear on the ballot. Getting the signatures is a crucial step. It’s a milestone in the fight to let voters decide in a state where Republicans have primarily succeeded in locking down control of government. But there’s another significant hurdle looming: the state itself. Moody’s brief, filed with the state Supreme Court, argues, essentially, that Floridians will be confused by the wording of the ballot summary. There’s no confusion in Florida, no matter what Moody — “the people’s lawyer” — says. Floridians aren’t unclear what it means to specify that right in the state constitution. Moody and the state need to get out of the way and let the people speak.

— PENCIL IT IN —

Monday

9 a.m. — The Social Services Estimating Conference meets. Room 117, Knott Building.

3 p.m. — The Health & Human Services Committee meets and will hear presentations on International Drug Reference Pricing from Andrew Mulcahy, Ph.D., a senior policy researcher at RAND Corporation, and Drew Gattine, senior policy fellow at the National Academy for State Health Policy.

Tuesday

It’s the start of the 60-day 2024 Legislative Session.

It’s Tech Day at the Capitol.

10 a.m. — Opening Day Events in the House.

11 a.m. — DeSantis delivers his State of the State address to a joint session of the Florida Legislature.

2:30 p.m. — The House meets in Session.

Wednesday

8:30 a.m. — The Senate Health Policy Committee meets. Room 412, Knott Building.

10:30 a.m. — The Senate Children, Families, and Elder Affairs Committee meets. Room 412, Knott Building.

11 a.m. — The House Health Care Appropriations Subcommittee meets. Room 17, House Office Building.

1:30 p.m. — The House Children Families & Seniors Subcommittee meets. Room 102, House Office Building.

3 p.m. — The Senate meets in Session.

Diagnosis is written by Christine Jordan Sexton and edited by Drew Wilson.