Welcome back to Diagnosis, a vertical that focuses on the crossroads of health care policy and politics.
OK, so a new budget is in place — time to begin the annual ritual of preparing for the next one.
State economists will meet over the next few weeks to draw up the all-important forecasts that prove pivotal for long-term budget outlooks — and eventually, the next budget that legislators will work on during the 2023 Session.
The current fiscal year kicked in on July 1 and runs until the end of June 2023.
Economists hold estimating conferences throughout the year, but the summer ones are important since they are the building blocks for the three-year outlook to be submitted to the Legislative Budget Commission in early September.
That’s the all-important planning tool that tells legislators whether they will have a budget surplus or a budget shortfall in the coming year. Several key forecasts are used for that calculation, including estimates for Florida KidCare, Medicaid caseloads and expenditures, federal matching fund rates for Medicaid, tobacco settlement dollars and state employees’ health insurance. These sessions will start Thursday and run to Aug. 16 when economists make a new general revenue forecast — the main source of state money for the budget.
Everyone expects that the bottom line will be good, and the state will have a substantial budget surplus (along with large reserves), although the recession clouds over the economy are hanging in there. One key factor regarding health care expenses is the expectation that President Joe Biden’s administration will extend the public health emergency related to COVID-19, which is set to expire Friday.
An extension means two items of importance for Florida: The state will continue to collect a higher matching rate for Medicaid from the federal government (needing less state money). But also, Florida cannot begin to remove enrollees from Medicaid until the public health emergency, first put in place two years ago, ends.
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— DeSantis vs. PHARMA —
Painting himself as a champion of reforms to hold the “pharmaceutical industrial complex” responsible, Gov. Ron DeSantis announced he was throwing his weight behind a requirement to limit pharmacy benefit managers and their “deceptive” pricing practices.
At a Cape Coral news conference late last week, DeSantis called PBMs a cottage industry, saying the pricing process is “so opaque you can see why money is potentially being skimmed.”
But the EO doesn’t apply to all PBMs, just the ones contracted with the state or subcontracted with entities that have contracts with the state.
That leaves the people with commercial health insurance (other than state employees) without protection from PBMs. According to the Florida Office of Insurance Regulation, there were 3,807,574 people enrolled in commercial policies in 2020.
PBMs represent health insurers, employers, and state government in the selection, purchase, and distribution of pharmaceuticals. They also organize and service pharmacy networks. Customers pay the PBMs to manage prescription drug costs, PBMs negotiate with the drug manufacturer to receive rebates.
PBMs also negotiate reimbursement and dispensing fees with network pharmacies and pharmacists.
The executive order notes that several states have enacted laws that increase reporting requirements to protect consumers and ensure transparency and accountability.
In the order, the Governor directs all agencies that contract for health care services to include language in future contracts that prohibit PBMs from using spread pricing and financial “claw backs.”
Spread pricing occurs when the PBM retains a part of the amount — known as “spread” — between what the employer or health plan pays the PBM for a member’s prescription and the amount that the PBM reimburses the pharmacy.
Claw backs refer to a contractual provision that allows PBMs to keep a part of the money it recoups during pharmacy audits.
The Agency for Health Care Administration and the Department of Management Services, which will obtain the managed Medicaid program and the state group health insurance plan, respectively, did not need the executive order to include the prohibitions in their upcoming contracts.
Agencies can include restrictions in their contracts without the order.
The Governor also notes in the executive order that several states have passed PBM reforms, but that “significant” reforms filed by lawmakers over the last several years “have been met with resistance from special interests.”
It’s worth noting that the DeSantis administration has avoided the PBM legislative debate so far, but with this latest effort it will be worth watching whether the administration continues to stay out of the debate.
AHCA Secretary Simone Marstiller said her agency would use the executive order as a baseline and that AHCA will be working on ways to ensure independent pharmacists “can serve not just the Medicaid population but all the members of (the) community without going out of business at the hands of the PBMs.”
— Keeping up with California? —
After expressing dissatisfaction with PBMs, a key part of the new executive order issued by DeSantis directs the AHCA to move ahead “expeditiously” in hiring a vendor to help the state negotiate prices for insulin and epinephrine.
The Legislature gave the agency authority to hire a vendor to obtain the drugs on behalf of the state as part of the new 2022-2023 budget that just took effect.
However, the Legislature didn’t appropriate any money to the agency to employ a vendor.
Instead, the vendor will be compensated on a contingency basis, paid from a part of the savings achieved by its price negotiation (or purchase) of insulin and epinephrine.
That means the vendor will be doing the work of a PBM, which DeSantis slammed in his news conference Friday.
The budget clarifies that the AHCA must competitively bid for the vendor service and that the agency must announce the bid and hire a vendor before June 30, 2023, when the budget and the agency’s authority negotiate for the costly drugs expire.
DeSantis made the announcement as California Gov. Gavin Newsom declared his state is preparing to produce its own supply of insulin. The California budget allocates $100 million to develop and manufacture biosimilar insulin products for Californians.
Half the $100 million will support the development of low-cost insulin products for residents. The remaining funds will be appropriated to a California-based insulin manufacturing facility to create high-paying jobs and a new insulin supply chain for residents.
— Med mal showdown? —
A centerpiece of Florida’s medical malpractice laws is being put to the test as the state Supreme Court prepares to weigh in on the merits of pre-suit requirements that require plaintiffs to file affidavits from expert medical witnesses qualified in the same specialty as the providers being sued.
In briefs filed with the high court, the University of Florida and Shands Teaching Hospital and Clinics argue that the requirement that a witness must be an expert in the same specialty as the medical provider being sued is a “salient, critical factor in assessing the reasonableness of the grounds to initiate a complex, multiyear cause of action for medical negligence.”
The Supreme Court agreed last week to allow the American Medical Association, the Florida Medical Association, and the Florida Hospital Association to file briefs supporting UF’s arguments.
The underlying case under review stems from a lawsuit filed by Laurie Carmody, alleging neurosurgeon William Friedland and advanced registered nurse practitioner Yolanda Gertsch-Lapcevic were negligent in their follow-up care following a November 2016 cervical disc fusion surgery.
Carmody developed abscesses requiring two follow-up surgeries, which left her disabled, the suit alleges.
In her pre-suit notice, Carmody included an affidavit by James DeStephens, an internal medicine and cardiology physician who worked as a hospitalist.
Shands motioned to dismiss the case, arguing that DeStephens did not meet the expert witness requirements. The court granted the motion to dismiss.
But the plaintiff filed a motion for rehearing, which the court initially denied.
The court did agree to grant an evidentiary hearing on whether DeStephens was qualified to render an expert opinion on the care provided by Gertsch-Lapcevic, the advanced registered nurse practitioner.
Following the evidentiary hearing, a circuit court reversed its motion to dismiss, opining that DeStephens was qualified to corroborate a claim against the ARNP because he had worked as a hospitalist and “currently treats patients post-operatively in his private practice,” which includes complaints of “incisional pain or swelling or redness,”
Shands appealed the decision to the 1st District Court of Appeals in Tallahassee, which in November 2021 ruled it did not have the authority to address non-procedural disputes.
The Tallahassee appellate court did acknowledge that its opinion differed from other appellate courts and certified a conflict to the state Supreme Court.
— Focus on fentanyl —
The Florida Department of Health issued a public health and safety alert reminding first responders that they can request free naloxone through the HEROS (Helping Emergency Responders Obtain Support) program.
Organizations interested in obtaining or managing naloxone for their communities can visit I SAVE FL to find available resources through the Florida Department of Children and Families.
The DOH, DCF and the Florida Department of Law Enforcement announced they are working together to investigate the” exponential” increases in fentanyl and fentanyl-related overdoses.
In 2020, more than 6,150 people died from overdoses involving fentanyl and fentanyl analogs in Florida. For 2021, the latest provisional drug overdose death counts also show an increase in fatal overdoses caused by synthetic opioids.
Nationally, 56,516 overdose deaths reported in 2020 were caused by synthetic opioids, mostly fentanyl.
The public health alert was sent after a spate of deaths occurred in Quincy after the Fourth of July weekend.
— RULES —
AHCA proposes amending Rules 59A-36.019 and 59A-36.025 about emergency environmental control for assisted living facilities. More here.
AHCA proposes amending Rule 59A-8.0095 governing home health agency personnel. More here.
AHCA proposes amending Rule 59A-8.0097 sets up training and validation requirements for home health aides and certified nursing assistants (CNAs); Rule 59A-8.0216 establishes criteria for the delegation of tasks by a registered nurse (RN) and supervisory requirements for home health aides and CNAs and Rule 59A-8.0219 sets up procedures for the administration of medication by home health aides and CNAs to home health agency personnel. More here.
AHCA proposes sending Rule 59A-9.034 about reporting requirements for abortion procedures to reflect the15-week ban. More here.
The Board of Respiratory Care proposes amending Rule 64 32-4.001 to consider and/or delinquency fee reduction or holiday. More here.
The Board of Medicine proposes amending Rule 64B8-9.0092 to add the American Accreditation Commission International (AACI) as an accrediting organization approved by the Board. More here.
— ROSTER —
Dr. Juan C. Cendan has been appointed senior vice president for health affairs and dean of the Florida International University Herbert Wertheim College of Medicine (HWCOM). Cendan, 56, practiced as a general surgeon in Gainesville after completing his medical training. He returned to UF as faculty, where he developed an academic focus on simulation-based medical education. He joined the University of Central Florida College of Medicine as founding faculty in 2010, serving several institutional roles, including assistant dean for Simulation, medical director of the Simulation Laboratory, and chair of the Department of Medical Education. Cendan served as the interim dean and professor of surgery at FIU’s medical school since summer 2021.
— ICYMI —
In case you missed them, here is a recap of other critical health care policy stories covered in Florida Politics this past week.
— Animated crowd: A two-hour meeting on a proposed rule to ban Medicaid from providing genders affirming care for people with gender dysmorphia felt more like a campaign rally than a health care meeting. There were boos and chants of “lock them up” from the crowd when someone spoke against the proposed changes. There were hurrahs, claps, and amens shouted during testimony in support of the ban.
— Not wasting time: Florida’s health care regulators are moving ahead with required rule changes to implement the state’s new law banning abortions after 15 weeks in the wake of the new law. Leon County circuit court judge John Cooper said the law violated a woman’s right to privacy, protected in the state constitution. But the DeSantis administration appealed the decision to the state Supreme Court, and the injunction banning the new law from taking effect has been lifted.
— Long-term COVID: Nearly 5,000 people who filed COVID-19-related workers’ compensation claims in 2020 have cases that remain open, according to the latest available state data.
— New digs, same mission? A state-assembled panel analyzing the harmful effects of harmful algal blooms is moving out of the Department of Health (DOH) and into the Florida Fish and Wildlife Conservation Commission, where it will be absorbed into the Harmful Algal Bloom (HAB) Task Force.
— Getting attention: Following a spree of deaths in Gadsden County this Fourth of July weekend, First Lady Casey DeSantis traveled to Quincy with a message of caution against illicit drugs. Officials are providing first responders with naloxone, also known by the brand name Narcan, which reverses the effects of opioids. Naloxone not only saves the lives of people who overdose but also the lives of emergency responders who come into contact with opioids.
— FOR YOUR RADAR —
Aside from coverage by Florida Politics, these stories are worthy of your time.
—“FSU hopes to address nursing shortage by attracting more students to program” by Regan McCarthy of WFSU — Florida State University has announced new initiatives to attract more students to its nursing program. It’s part of an effort to address the ongoing nursing shortage worsened by the coronavirus pandemic.
—“‘Absolutely be concerned.’ Monkeypox cases are surging in South Florida” via Anuraag Bukkuri and Daniel Chang of the Miami Herald — Less than eight weeks ago, the Florida Department of Health reported the state’s first presumptive case of monkeypox — a viral disease that was once rare in the United States. Now, as the number of new monkeypox cases has risen rapidly in the United States and more than 50 other countries, Florida’s case count is also surging, to 73 as of Thursday, the third most of any state, after California and New York, according to the Centers for Disease Control and Prevention. There were 700 confirmed U.S. cases as of Thursday, the CDC said. And South Florida is the epicenter of the state’s outbreak, with Miami-Dade and Broward counties accounting for more than 70% of all reported cases in Florida.
—“Floating abortion clinic proposed in Gulf to bypass bans” via The Associated Press — A California doctor is proposing a floating abortion clinic in the Gulf of Mexico to maintain access for people in southern states where abortion bans have been enacted. The idea is to provide a clinic aboard a ship in federal waters, and out of reach of state laws that would offer first-trimester surgical abortions, contraception and other care, said Dr. Meg Autry, an obstetrician and gynecologist and a professor at the University of California San Francisco.
—“A Florida nursing home lost its Medicare benefits. Residents lost a home” via Hannah Critchfield of the Tampa Bay Times — Drawers opened and shut. Garbage bags filled with clothes, birthday cards and pocketbooks. They had to go. So did 95-year-old Judith Goodman. Goodman had called Raydiant Health Care of Brandon her home for 13 years. By the next day, she would be gone. “I feel horrible — I don’t want to leave,” she said late last month as she watched her two daughters pack her belongings. “But what can I do?” Residents of the 120-bed Tampa Bay nursing home learned in June that it was closing. They said they were told that they had 30 days to find places to live.
—“UF Health sees 50% increase in vasectomies as Roe v. Wade overturned” via Gershon Harrell of The Gainesville Sun — More men are seeking vasectomies since the overturning of Roe v. Wade, a ruling that long had protected abortion rights for women, University of Florida Health reports. According to UF Health urology consultants, men booking the procedure have increased by about 50% compared to previous months. The UF urology department schedules about 40 vasectomy procedures and consults monthly. When Roe v. Wade was overturned, 26 vasectomies were scheduled that week alone. “There’s a lot of things going on nationally revolving around reproductive autonomy. Whether we’re talking June or July 2022 versus 2021 … a lot of guys have this idea of a vasectomy in the back of their mind as a good way to firmly establish contraception,” said Dr. Kevin Campbell.
The Department of Transportation has approved Sarasota Memorial Hospital North Port ER Helistop, a private airport in Sarasota County, to be owned and operated by Sarasota County Public Hospital Board. More here.
— PENCIL IT IN —
4 p.m. Rep, Carlos Guillermo Smith holds a news conference on preventing the spread of meningococcal disease and monkeypox in communities. It will be streamed live on facebook.com/carlosguillermoforflorida and bit.ly/RepCGSYouTube/
9 a.m. Social Services Estimating Conference meets to discuss Florida KidCare caseload. 117 Knott Office Building, Tallahassee
Noon The state Alzheimer’s Disease Advisory Committee meets. Florida Department of Elder Affairs, 4040 Esplanade Way, Tallahassee. Meeting link here. Meeting ID: 85484909428. Code: 301360
Happy birthday to Rep. Michael Grant
9 a.m. The Florida Board of Hearing Aid Specialists meets. Sheraton Sand Key Resort 1160 Gulf View Blvd., Clearwater Beach.
10 a.m. The Board of Medicine North Probable Cause Panel meets. Meeting link here.