Advocacy

    2021 Legislative Session

    Click here for the Week 9 update on bills the FCACC is following. The bills marked “ENROLLED” have passed the Legislature and will be presented to the Governor for final action. Now that Session has ended, once the bill is presented to him, he will have 15 days to sign a bill into law, allow it to become law without his signature or veto the legislation.

    Week 9 Sine Die Highlights

    Lawmakers have concluded their work in Tallahassee for the 2021 Legislative Session and have adjourned SINE DIE!

    Just prior to adjourning, the Legislature approved a $101.5 billion state spending plan which includes $6.7 billion in federal COVID-19 relief money. The budget earmarks $240 million – $89 million in state revenues – to extend the period of Medicaid eligibility for new mothers from 60 days to one year after giving birth, a stated priority of House Speaker Chris Sprowls.

    One of the bills of interest that passed this week is SB 2006 which makes permanent a ban on COVID-19 vaccine “passports.” The bill would also allow the Governor to override local orders during health crises and directs state agencies to plan for future pandemics. In addition to barring COVID-19 passports, the measure would require local emergency orders to be narrowly tailored and to be extended in seven-day increments for a maximum duration of 42 days. Currently, such orders can be issued initially for seven days and extended indefinitely in seven-day increments. The bill would give the Governor power to override local orders if they are determined to “unnecessarily restrict individual rights or liberties.” Among other aspects of the bill, state agencies would be required to develop by the end of 2022 public health emergency plans, and the Division of Emergency Management would have to stockpile personal protective equipment.

    One of the major bills that did not make it through this Session is HB 969 on Data Privacy.  Legislative leaders were unable to reconcile their differences on the ‘private right of action’ and how lawsuits would be handled. The Senate supported giving lawsuit authority only to the Attorney General, while the House maintained allowing any consumer to sue. The legislation is expected to return for the 2022 Session.

    Lawmakers will be back in Tallahassee the week of May 17 for a Special Legislative Session to ratify the recent agreement between the State of Florida and the Seminole Tribe of Florida. If the compact is approved, legal challenges are expected by anti-gambling groups. Federal approval will also be required.

    NEW DEVELOPMENTS

    Cardiac Rules Challenged

    Six rule challenges by some of Florida’s largest health-care entities have been filed during the past two weeks against Florida Agency for Healthcare Administration (AHCA). 

    The challenges which were filed with the Division of Administrative Hearings are against two new proposed Agency rules.  Rule 59A-3.246, FAC regulating organ transplant programs and Rule 59A-3.248 regulating pediatric cardiac services. The proposed new rules will replace the prior Certificate of Need (CON) regulatory program for new hospitals and complex medical services which was repealed by the Florida Legislature two years ago.

    Prior to 2019, organ transplant in Florida was governed by the Certificate Of Need standards.  In 2018, the FL Legislature instructed AHCA to adopt rules and requirements for the organ transplant licensure separate and apart from the CON Requirements.   They also required them to adopt rules establishing standards for pediatric cardiac catheterization and pediatric cardiovascular surgery programs.  As a result of the mandate, the Agency initiated rule development for Rule 59A-3.246 FAC and Rule 59A-3.248 FAC .  In 2019, the Florida Legislature abolished the CON Regulatory Program.

    During March of 2019, the Agency issued the proposed language for the rules for organ transplant.  In February of 2020, AHCA issued notice for the rules workshop and posted a new draft of proposed language for organ transplants on its website.  No formal agency was taken by AHCA until early April 2021 when it published the current versions of rules that are being challenged. For the pediatric cardiac services rule, the Agency initiated rulemaking to align with the Statutory requirements (395.1055) but no rule language was officially proposed until March of 2021.

    One of the argument raised in the petitions is that ACHA’s proposed new rule requires that hospitals maintain minimum volume standards authorized under a federal Medicare rule. In their petition, the healthcare entities raised concerns that the Medicare rule doesn’t contain minimum volume requirements for pediatric organ transplant programs. Additionally, the minimum volume requirements in the  federal rules are only required for initial approval and only have to be followed during the first year of a new transplant program.

    Tampa General Hospital and Adventist Health System filed challenges to the proposed organ-transplant rule (59A.-3.246) , while UF Health Shands and Miami’s Jackson Memorial Hospital joined together to challenge the rule’s  provision regarding patient thresholds that hospitals must meet to offer adult and pediatric transplant services. A hearing on the Adventist Health System /Organ Transplant Rule challenge has been set for June 22nd-23rd while the hearings for Tampa General Hospital and UF Health Shands/Miami Jackson Memorial/ challenges have not.

    Johns Hopkins All Children's Hospital, Nemours Children's Hospitals and Holtz Children’s Hospital at Jackson Memorial also filed challenges to the AHCA proposal rule (59A-3.248) regulating pediatric cardiac-care services. While these hospitals each filed separate challenges, the three cases have been consolidated into one and a hearing has been set for May 18-20th.

    BILLS OF INTEREST ACTED ON BY THE GOVERNOR

    Protecting Consumers Against Pandemic-related Fraud

    HB 9– SIGNED INTO LAW

    The legislation authorizes civil remedies and establishes criminal penalties for those intending to defraud regarding the availability of or access to a COVID vaccine.

    Taxation of Online Sales

    SB 50– SIGNED INTO LAW

    The law, which takes effect on July 1st, requires out-of-state retailers and marketplace providers with no physical presence in the state to collect Florida’s sales tax on sales of taxable items delivered to purchasers in Florida if the out-of-state retailer or marketplace provider makes a substantial number of sales into Florida. Revenue derived from these collections will be used to replenish the Unemployment Compensation Trust Fund depleted by the COVID-19 Pandemic, ensuring necessary compensation is available for Florida workers seeking re employment. When the trust fund reaches pre-pandemic levels, the new law automatically triggers a permanent reduction in the business rent tax.

    Civil Liability for Damages Relating to Covid-19

    SB 72– SIGNED INTO LAW

    Among other measures, the legislation provides immunity from COVID-19 related claims for individuals, businesses, schools, and houses of worship if a good faith effort was made to comply with health standards and guidance related to COVID-19. The bill also creates strong affirmative defenses for health care providers that substantially complied with and relied upon health standards.

    BILLS OF INTEREST THAT HAVE PASSED THE LEGISLATURE

    Rare Disease Advisory Council

    SB 272

    The legislation calls for a twenty member Council to provide recommendations on ways to improve health outcomes for individuals with rare diseases. While we are cautiously optimistic that the bill will ultimately pass, with only one week to go in the session and many other issues in the air, nothing is certain until the gavel falls.

    Practice of Physician Assistants

    HB 431

    The legislation revises how physician assistants can perform their work by allowing them to:

        • Prescribe psychiatric mental health controlled substances to minors under certain circumstances;
        • Procure certain medical equipment and devices;
        • Supervise medical assistants;
        • Sign and certify documents that currently require a physician’s signatures such as Baker Act commitments, do-not-resuscitate orders, school physicals, and death certificates;
        • Expands the number of PAs that a physician can supervise to 10; and
        • Authorizes physician assistants to directly bill for and receive payments from public and private insurance companies for the services they deliver.

    Dispensing Medicinal Drugs

    SB 262 

    The legislation authorizes medicinal drugs to be dispensed by a hospital that operates a Class II or Class III institutional pharmacy to a patient of the hospital’s emergency department or a hospital inpatient upon discharge if a prescriber treating the patient in the hospital determines that:

        • The medicinal drug is warranted; and
        • Community pharmacy services are not readily accessible to the patient, geographically or otherwise.

    If prescribing and dispensing occurs, the bill requires that a supply of the drug must be dispensed that will last for the greater of up to 48 hours or through the end of the next business day, and that during a declared state of emergency, a 72-hour supply may be dispensed by a hospital located in an area affected by the emergency.

    Administration of Vaccines

    SB 768

    The legislation authorizes pharmacists and pharmacy interns to administer any immunization or vaccine that is:

        • Listed in the federal Centers for Disease Control and Prevention’s (CDC) Recommended Immunization Schedule;
        • Listed in the CDC’s Health Information for International Travel;
        • Listed in the Food and Drug Administration’s (FDA) Vaccines Licensed for Use in the United States; or
        • Authorized vaccine for emergency use by the FDA.

    Tobacco and Nicotine Products

    SB 1080

    The legislation relates to the regulation of the retail sale of tobacco products and nicotine products. The bill:

        • Increases the minimum age to lawfully purchase and possess tobacco products and nicotine products from 18 years of age to 21 years of age.
        • Creates a new part of ch. 569, F.S, to regulate the sale of, and create a separate licensing structure for, the sale of “nicotine dispensing devices” and nicotine products.
        • Preempts to the state the establishment of a minimum age for purchasing or possessing tobacco or nicotine products as well as regulation of the marketing, sale, or delivery of tobacco or nicotine products.
        • Prohibits smoking and vaping by any person under 21 years of age on or near school property.
        • Keeps the exemption in current law for underage persons in the military and persons acting in the scope of lawful employment.
        • Requires age verification before a sale or delivery of tobacco products to person who appear to be under 30 years of age.

    Medicaid

    HB 1057

    The Legislation revises a number of provisions regarding the State’s Medicaid program. Among other things, the legislation makes changes to provisions setting reimbursement rates for providers of prescribed drugs.

    Currently, a provider of prescribed drugs must be reimbursed the least of the amount billed by the provider, the provider’s usual and customary charge, or the Medicaid maximum allowable fee established by the agency, plus a dispensing fee. The Medicaid maximum allowable fee for ingredient cost must be based on the lowest of: the average wholesale price minus 16.4 percent, the wholesaler acquisition cost plus 1.5 percent, the federal upper limit, the state maximum allowable cost, or the usual and customary charge billed by the provider.

    Under the bill, a provider of prescribed drugs will be reimbursed in an amount not to exceed the lesser of the actual acquisition cost based on the federal CMS National Average Drug Acquisition Cost pricing files plus a professional dispensing fee, the wholesale acquisition cost plus a professional dispensing fee, the state maximum allowable cost plus a professional dispensing fee, or the usual and customary charge billed by the provider.

    Health Care

    SB 2518

    This legislation, which is one of the bills accompanying the state budget, conforms the law to funding decisions made in the state budget related to income thresholds for residents of state veteran nursing homes, the Medicaid program, Low Income Pool Program payments, the Disproportionate share program, and the Program of All-inclusive Care for the Elderly (PACE) utilized in numerous counties throughout Florida.

    Medicare Transportation Services

    SB 348

    The legislation requires Florida Medicaid to reimburse for Medicare “crossover claims” for nonemergency ambulance services. Currently, Medicaid pays for emergency transportation crossover claims but not for non-emergency transportation crossover claims. A “crossover claim” is a claim for a recipient who is eligible for both Medicare and Medicaid, where Medicare pays a portion of the claim, and Medicaid is billed for any remaining deductible and/or coinsurance. The bill requires Florida Medicaid to pay all deductibles and coinsurance for Medicare-covered services provided to Medicare-eligible recipients by ambulances licensed pursuant to chapter 401, Florida Statutes, according to the corresponding procedure codes for such services. Currently, Medicaid must pay all deductibles and coinsurance for Medicare emergency transportation services provided by ambulances licensed pursuant to chapter 401, Florida Statutes.

    Parents' Bill of Rights

    HB 241

    The bill creates the “Parents’ Bill of Rights” outlining rights of a parent regarding his or her minor child for education, health care, and criminal justice procedures. The bill prohibits the state, its political subdivision, any other governmental entity or any other institution from infringing upon the fundamental right of a parent to direct the upbringing, education, health care, and mental health of his or her minor child. The bill also requires a health care practitioner, or his or her employees, to obtain parental consent before performing health care services on a minor child and subjects health care practitioners and health care facilities to disciplinary action for violation of these parental consent requirements in certain instances.

    Foreign Influence

    HB 7017

    The legislation is aimed at addressing foreign influence in Florida’s state-funded research institutions as a result of the findings of the House Select Committee on Integrity of Research Institutions, which resulted from specific instances of Florida researchers engaging in questionable conduct in conjunction with China. The bill requires state institutions of higher education to disclose foreign gifts above $50,000, more fully screen foreign applicants for research positions and monitor and report on employment-based foreign travel. Furthermore, the legislation prohibits certain agreements with China, Cuba, Iran, North Korea, Russia, Syria and Venezuela that are detrimental to the security of the United States or allow for foreign control of decisions.

    Corporate Espionage

    HB 1523

    The Legislation increases the penalties for intellectual property theft that benefits a foreign nation or agent and creates a trafficking in trade secrets crime for any person who traffics or attempts to traffic in trade secrets they know or should have known was stolen.

    Unlawful Use of DNA

    HB 833

    The bill makes it a criminal offense to extract, retain, analyze or transfer a person’s DNA without the express consent of a person and continues to provide criminal penalties for violation of its provisions. The bill applies to a DNA sample collected from a person in Florida, and to use, retention, maintenance and disclosure of such person’s DNA sample or the results of a DNA analysis after the effective date  of this act.

    Among the exceptions to the crimes established in the bill is the medical diagnosis, the conducting of quality assessments, improvement activities, and treatment of a patient when express consent for clinical laboratory analysis of the DNA sample was obtained by the health care practitioner who collected the DNA sample or when performed by a clinical laboratory certified by the Centers for Medicare and Medicaid Services;

    Further, the bill does not apply to a DNA sample, a DNA analysis, or the results of a DNA analysis used for the purposes of conducting research, and designing and preparing such research, subject to the requirements of, and in compliance with, 45 C.F.R. part 46, 21 C.F.R. parts 50 and 56, or 45 C.F.R. parts 160 and 164; or utilizing information that is de-identified consistent with 45 C.F.R. parts 160 and 164 and that is originally collected and maintained for research subject to the requirements of, and in compliance with, 45 C.F.R. part 46, 21 C.F.R. parts 50 and 56, or 45 C.F.R. parts 160 and 164.  

    Emergency Management

    SB 2006

    The bill prohibits businesses, schools and government agencies from requiring people to show documentation certifying COVID-19 vaccinations or post-infection recovery before gaining entry. It also removes the bill’s express authorization for the State Health Officer to create screening protocols consistent with the bill’s provision prohibiting governmental, educational, and business entities to require proof of COVID-19 vaccination or recovery to receive services.

    Taxation

    HB 7061

    The legislation delivers tax relief with a focus on sales tax holidays that offer a savings for Floridians preparing for the upcoming 2021 Hurricane Season and the 2021-2022 school year, as well as individuals and families enjoying outdoor activities and events. The bill also expands the current tax exemption for affordable housing properties and creates a permanent sales tax exemption for items that support independent living. The bill also:

        • Repeals the hospital community benefit reporting statute, 193.019;
        • Includes a charitable, religious, scientific or literary property exemptions;
        • Includes an Allocation of 7% (from 2021-2024) and 10% (from 2024-2054) of the cigarette tax to Moffitt Cancer Center and Research Institute;
        • Includes an internship tax credit program which allows businesses to take a $2,000 deduction per student intern;
        • Codifies the reduction in commercial lease tax from the current 5.5 to 2.0%;
        • Maintains the state’s research and development tax credit at the base $9 million.

    Autonomous Vehicles

    HB 1289

    The legislation defines the term “low-speed autonomous delivery vehicle” (LSADV) as a fully autonomous vehicle that meets the current federal definition of low-speed vehicle, and is not designed for, or capable of human occupancy. The bill authorizes LSADVs to operate only on streets or roads with a posted speed limit of 35 miles per hour or less but does not prohibit such vehicles from crossing a road or street at an intersection where the road or street has a posted speed limit of more than 35 miles per hour. An LSADV may operate on a street or road with a posted speed limit of more than 35 miles per hour, but no more than 45 miles per hour under limited circumstances. The bill also clarifies that low-speed autonomous delivery vehicles are not subject to certain statutory provisions applicable to low-speed vehicles, including provisions related to seasonal deliveries and driver license requirements. 


      CORONAVIRUS AND YOUR HEART: DON'T IGNORE HEART SYMPTOMS

      ACC CardioSmart recently published the infographic below to emphasize the importance of maintaining heart health through the epidemic. Click here for additional information.

      Heart Health During COVID-19 graphic

      TALLAHASSEE

      The FCACC has a strong presence in the state capital where we meet with lawmakers and work with other like-minded organizations to support legislation. Our goal is to be the source of knowledge for cardiovascular health information.  Updates on bills we follow in session are posted on this page along with update on activities in the Capital.
      Click here to find your Florida Senators and Representatives. WASHINGTON, DC

      Although a state chapter, the FCACC has an impact and voice at the Federal level. Working in concert with the other 49 chapters of the ACC and with Heart House leaders and staff we have a network of contacts with our Congressional delegation. If you would like to serve as a key contact email jennifer@accfl.org. Key contacts sit down with lawmakers in-district and in Washington to explain in detail the impact of bills on our patients and profession and form a relationship with our lawmakers and their staff. 

      ADVOCACY COMMITTEE

      Charge: The Advocacy Committee is charged with advocating for CV medicine and communicating with the lawmakers and regulators of Florida on issues relating to improving the cardiovascular health of all Floridians and to promoting access to quality cardiovascular care in Florida.
       
      David Kenigsberg, MD, FACC, Chair, Plantation


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