The 2011 Legislative Session was one of the Florida Medical Association’s most challenging in many years. The sheer number and intensity of legislative proposals affecting the practice of medicine exceeded our expectations. The battles began with the very first committee on the first day of session, and they didn’t end until the Legislature adjourned at 3:30 a.m. on May 7. In spite of those challenges, the FMA achieved a major victory for Florida physicians with the overwhelming passage of our medical malpractice reform bill, HB 479. We also were successful in extending sovereign immunity protection to physicians at teaching hospitals, defeating inappropriate scope-of-practice expansion attempts, limiting noneconomic damages for physicians sued by Medicaid patients, and much more. The following is a comprehensive breakdown of bills the FMA pushed through and defeated this session. SUCESSFUL LEGISLATION SUPPORTED BY THE FMA The FMA’s medical malpractice bill, HB 479 by Rep. Mike Horner (SB 1590 by Sen. Alan Hays), was our signature legislation for the session. After a decade of effort, the FMA was finally successful in passing legislation containing expert witness reform and several other important provisions. This resulted in the most important tort reform legislation since the caps on noneconomic damages were enacted in 2003. The bill that now goes to Gov. Rick Scott for approval contains the following provisions: • Requires an M.D., DO, or D.D.S licensed in another state to obtain an expert witness certificate before being able to provide expert testimony in Florida. • Gives the Boards of Medicine, Osteopathic Medicine, and Dentistry the specific authority to discipline any expert witness, both those licensed in state and those with an expert witness certificate, who provide deceptive or fraudulent expert witness testimony. • Requires the Board of Medicine and the Board of Osteopathic Medicine to create a standard informed consent form that sets forth the recognized risks related to cataract surgery. Provides that an incident resulting from a recognized specific risk is not considered an adverse incident. • Deletes the provision in current law that prohibits an insurance company from selling a malpractice insurance policy to a physician that gives the physician the authority to control settlement decisions. 1 • Excludes from evidence in any medical negligence action any information regarding an insurer’s reimbursement policies or reimbursement determinations. The prime example would be a Medicare "never event." If Medicare denied reimbursement for a hospitalacquired infection because it never should have happened, that payment decision is not admissible to show a breach of the standard of care. • Provides that the breach of, or failure to comply with, any federal requirement is not admissible as evidence in a medical negligence case. • Provides that the expert witness who submits the pre-suit verified expert medical opinion is no longer immune from discipline. • Creates a new pre-suit form, the “authorization for release of protected health information.” This will make it easier for a physician to obtain the patient’s health care information in a malpractice suit, and will eventually make it easier to pass legislation allowing equal access to treating physicians. • Provides that volunteer team physicians are immune from suit when gratuitously rendering care at a school athletic event. SB 1676 by Sen. Thrasher (HB 1393 by Rep. Frank Artiles), the “University of Miami sovereign immunity” bill, provides that any nonprofit independent college or university located and chartered in Florida and that owns or operates an accredited medical school and has a contract to provide patient services as agents of a teaching hospital, is considered an agent of the teaching hospital while acting within the scope of the contract. While potentially broader, this bill’s main effect will be to confer sovereign immunity on the University of Miami medical school while providing services for Jackson Memorial. HB 395 by Rep. O’Toole (SB 626 by Sen. John Thrasher) gives the Shands hospital system, both the Jacksonville and Gainesville facilities, sovereign immunity and will potentially save Shands $12 million a year in insurance premiums. HB 1319 by Rep. Gayle Harrell (SB 1228 by Sen. Thad Altman) provides that a health care professional board may issue a temporary professional license to the spouse of an active duty member of the Armed Forces, under certain conditions. The chief condition is that the applicant must hold a valid license to practice issued by another state, and is not the subject of any disciplinary proceeding. SJR 2 by Sen. Mike Haridopolos (HB 1 by Rep. Scott Plakon) is a proposed constitutional amendment to be submitted to voters for approval or rejection in the next general election. This 2 resolution, which the FMA supports, is designed to undo the mandatory insurance provision of the Patient Protection and Affordable Care Act (PPACA), and would make it unconstitutional for any law or rule to compel any person or employer to purchase, obtain, or otherwise provide for health care coverage. The resolution also would provide that a health care provider may accept direct payment for lawful health care services and may not be required to pay penalties or taxes for doing so. To pass, this resolution will need 60-percent of voters to approve it Closely related is HB 1193 by Rep. Matt Hudson (SB 1754 by Sen. Rene Garcia), which enacts a statutory prohibition against the mandatory purchase of health insurance, with certain exceptions. HB 137 by Rep. Ronald Renuart (SB 414 by Sen. Steve Oelrich) removes the Prostate Cancer Awareness Program from the Department of Health and provides that the University of Florida Prostate Cancer Disease Center shall establish the UFPDC Prostate Cancer Advisory Council and lead the council in developing and implementing strategies to improve outreach and education, thereby reducing the number of patients who develop prostate cancer. LEGISLATION THE FMA WAS ABLE TO MODIFY HB 7095 by Rep. Robert Schenck, House Health and Human Services Committee Chair, (SB 818 by Sen. Mike Fasano) proved to be this session’s most vexing bill. Despite the passage of legislation designed to address the pill mill problem during the 2009 and 2010 legislative sessions, there was tremendous pressure on legislators to “do something” about the pill mill scourge and controlled substance medication abuse. The Senate preferred a more measured approach, adopting the Attorney General’s recommendations, which called for harsher penalties on those who break the law. The House, on the other hand, adopted a more radical approach and backed legislation that would have banned physicians and small pharmacies from dispensing any controlled substances. The House bill also would have required all physicians who dispense controlled substances for the treatment of chronic, nonmalignant pain to register with the state, pay a fee, and follow certain guidelines for which the failure to comply would have been a mandatory six-month suspension and $10,000 fine. Up until the last day of session, it appeared the more moderate Senate approach would prevail. At the last minute, however, The Attorney General, House, and Senate worked out a compromise. The compromise language was released mere minutes before the Senate took up the bill on the floor. Despite the FMA’s aggressive lobbying and attempts to amend the final product, the bill passed out of both chambers and will certainly be signed by the governor. As passed, HB 7095 does the following: 3 Provides that the failure to comply with the newly created controlled substance prescribing requirements is grounds for discipline. Provides that prescribing or dispensing a controlled substance in a manner that violates existing standards of practice will result in a suspension of at least six months and a fine of at least $10,000 per count. Provides that a controlled substance prescription must have the quantity of the drug prescribed in both textual and numerical formats, and must be either written on a standardized counterfeit-proof prescription pad or electronically prescribed. Provides that effective Jan. 1, 2012, a physician who prescribes any controlled substance for the treatment of chronic nonmalignant pain must designate himself/herself as a controlled substance prescribing practitioner on the physician’s practitioner profile, and must comply with the newly created standards of practice. Creates new standards of practice. While this section is poorly written, it presumably applies to physicians who have to register as a controlled substance prescribing practitioner. The standards are more than four pages long, resembling the requirements promulgated by the Board of Medicine. It is interesting to note that the registration requirements and the standards of practice do not apply to the following: o Board-certified anesthesiologists, physiatrists, or neurologists. o A board-certified physician who has surgical privileges at a hospital or ambulatory surgery center and primarily provides surgical services. o A board-certified medical specialist who also has completed a fellowship in pain medicine approved by the Accreditation Council for Graduate Medical Education (ACGME ) or the American Osteopathic Association (AOA). o A board-certified medical specialist who is board-certified in pain medicine by a board approved by the American Board of Medical Specialties or the AOA, and performs interventional pain procedures of the type routinely billed using surgical codes. Changes the definition of a pain management clinic to a facility that advertises in any medium for any type of pain management services, or where in any month a majority of patients are prescribed opioids, benzodiazepines, barbiturates, or carisoprodol for the treatment of chronic nonmalignant pain. The FMA secured an agreement to delete the advertising component, but that agreement was inadvertently left out of the final compromise language. An effort to put the language in another bill was unsuccessful. Exempts the following from having to register as a pain management clinic: o A clinic wholly owned and operated by one or more board-certified anesthesiologists, physiatrists, or neurologists. 4 o A clinic wholly owned and operated by one or more board-certified medical specialists who also have completed fellowships in pain medicine approved by the ACGME, or who are also board-certified in pain medicine by an ABMS board and perform interventional pain procedures of the type routinely billed using surgical codes. Deletes the requirement that effective July 1, 2012, to practice in a pain management, a physician must have successfully completed an ACGME-accredited pain medicine residency or fellowship. Changes the requirement that a physician must perform a physical examination on the same day that he/she prescribes a controlled substance to allow the physical exam to also be done by a PA or ARNP. Provides for a number of facility and physical operating requirements for painmanagement clinics. These were taken from the rules promulgated by the Board of Medicine. Makes it a third-degree felony and grounds for administrative discipline for a physician to dispense a controlled substance listed in Schedule II or III, with certain exceptions. A physician who is a dispensing practitioner may still dispense Schedule II and III controlled substances as follows: o That are complimentary packages of medicinal drugs (drug samples). o In the health care system of the Department of Corrections. o In connection with the performance of a surgical procedure, not to exceed a 14-day supply and not to occur more than 14 days after the surgical procedure. The definition of a “surgical procedure” tracks the rules for level II and III office surgeries but applies to any setting. o Pursuant to an approved clinical trial. o In a methadone facility licensed under s. 397.427. o To a patient of a nursing home facility. Enacts a number of requirements for pharmacies and pharmacists. Enacts new regulations on prescription drug wholesalers and re-packagers. Adds additional criminal penalties for controlled substance theft in a structure or conveyance. Requires fingerprints and a background check of the program manager and support staff who have access to the prescription drug-monitoring database. Prohibits the use of funds from prescription drug manufacturers to implement the prescription drug database program. 5 Adds Schedule V controlled substances to the list for which a counterfeit-resistant prescription blank must be used. Requires each person who engages in the compounding, mixing, dispensing, etc., of a controlled substance to report the theft or significant loss of controlled substances to the sheriff within 24 hours after discovery. A person who fails to do so commits a seconddegree misdemeanor (for Schedule III, IV or V) and first-degree misdemeanor (for Schedule II). Makes it unlawful to obtain or attempt to obtain a prescription for a medically unnecessary controlled substance by misrepresentation, fraud, forgery, deception, subterfuge, or concealment of a material fact. Makes it unlawful for a health care practitioner to provide a medically unnecessary prescription for a controlled substance by misrepresentation, fraud, forgery, deception, subterfuge or concealment of a material fact. Provides grounds for declaring a pain-management clinic a public nuisance. Provides that dispensing practitioners shall ensure that the un-dispensed inventory of Schedule II and III controlled substances is returned to the wholesale distributor or given to local law enforcement agencies, and abandoned. Provides that wholesale distributors shall buy back the un-dispensed inventory of Schedule II and III controlled substances that are in the manufacturer’s original packing, unopened, and in date in accordance with the wholesaler’s policies. Provides that 30 days after July 1, 2011, the only legal way for a dispensing practitioner to sell or otherwise transfer a Schedule II or III controlled substance is through abandonment procedures or pursuant to a dispensing exception. Requires the State Health Officer to declare a public health emergency on July 1, 2011, and for various state agencies to identify dispensing practitioners who purchased a large amount of controlled substances in the previous six months, and identify those who pose the greatest threat to public health. On July 4, law enforcement agencies shall enter the premises of dispensing practitioners who pose the greatest threat to public health and quarantine any remaining inventory of Schedule II and III controlled substances. Law enforcement is required to ensure the security of this inventory until it can be seized as contraband or deemed to be lawfully possessed for dispensing by the physician. This poorly written bill then provides that on the 31st day after July 1, 2011, any remaining inventory of Schedule II or III controlled substances purchased for dispensing by practitioners is deemed contraband and seized. The foundation for this year’s Medicaid reform legislation was laid last session, when both chambers agreed that Medicaid recipients should be placed in managed care plans, but could not 6 agree on the details. This session, they were able to come up with a plan acceptable to both sides, and passed HB 7107 and 7109, the “Medicaid Managed Care” act. This legislation establishes the Medicaid program as a statewide, integrated managed care program for all covered services. All Medicaid recipients (with a few exceptions) shall receive covered services through an “eligible” managed care plan. “Eligible” plans include health insurers, exclusive provider organizations, health maintenance organizations, provider service networks PSNs), accountable care organizations (ACOs), and (for the managed medical assistance program) the Children’s Medical Services Network. This legislation also establishes a long-term care managed care program, which is not dealt with in this summary. With the exception of a two-year phase-in period in which ACOs and PSNs may receive fee-for-service rates, all eligible plans must be licensed or certified as a riskbearing entity and shall be paid a prospective per-member, per-month, risk-adjusted payment by the Agency for Health Care Administration (AHCA). It will be necessary for the state to obtain a federal waiver for this new Medicaid managed care plan before it can take effect. Perhaps of most interest to physicians who see Medicaid patients is the section titled “LIMITATION ON NONECONOMIC DAMAGES FOR NEGLIGENCE OF A PRACTITIONER PROVIDING SERVICES AND CARE TO A MEDICAID RECIPIENT.” The FMA worked hard to craft this provision and ensure its inclusion in the final product. This provision establishes a $200,000 cap on the amount of noneconomic damages that any one physician (dentist, hospital, etc.) may be liable for in a lawsuit brought by a Medicaid recipient. If there are multiple defendants, noneconomic damages may not exceed $300,000 per claimant. This cap can be exceeded only by proving, by clear and convincing evidence, that the physician acted in a “wrongful manner.” The term “wrongful manner” is purposely defined to mean “in bad faith or with malicious purpose or in a manner exhibiting wanton and willful disregard of human rights, safety, or property.” Following is a summary of the new program’s key provisions: The number of eligible plans selected to participate in the Medicaid program shall be limited. The state is divided into 11 different regions. The number of eligible plans is fixed for each region, ranging from a maximum of two in the region that includes Leon County, to a maximum of 10 in the region that includes Dade County. AHCA shall select the plans in each region using an invitation to negotiate, and in addition to the criteria it develops, AHCA must consider a number of statutory factors. Of note is the requirement to consider the availability and accessibility of primary care and specialty physicians in the provider network, and evidence that an eligible plan has written agreements or has made substantial progress in establishing relationships with providers. 7 Each region must have at least one PSN (if a qualified PSN bids). Preference must be given to plans that meet certain criteria, such as having a well-defined program for recognizing and providing increased compensation for patient-centered medical homes. Another is having a claims payment process ensuring that claims that are not contested or denied will be paid promptly, pursuant to the commercial HMO prompt pay statute. The agency shall exercise a preference for plans with a provider network in which over 10 percent of the providers use electronic health records. When all other factors are equal, the agency shall consider whether the organization has a contract to provide managed long-term care services in the same region. The agency shall contract with a single provider service network to function as a managing entity for the Medipass program in all counties with fewer than two prepaid plans. This provision expires Oct. 1, 2014, or upon full implementation of the managed medical assistance program. Upon federal approval, the agency shall contract with a single provider service network to function as a third-party administrator and managing entity for the Medically Needy program in all counties. This provision expires same as above. For the first year, the capitation rates or fee-for-service payments must guarantee an aggregate savings of at least 5 percent. While physician reimbursement is not directly increased, the legislation does provide that managed care plans are expected to coordinate care, manage chronic disease, and prevent the need for more costly services. Effective care management should enable plans to redirect available resources and increase physician compensation. This performance standard is achieved when payment rates equal or exceed Medicare rates. AHCA may impose fines on plans that fail to meet this standard after two years of operation. Managed care plans must pay non-contracted providers for emergency services and must comply with the commercial HMO prompt payment statute. Each managed care plan must maintain a region-wide network of providers in sufficient numbers to meet the access standards for specific medical services for all recipients. With a few exceptions, managed care plans may limit the providers in their networks based on credentials, quality indicators, and price. The legislation creates a category called “essential Medicaid providers” for which special rules apply. Thankfully, in this instance, physicians and other practitioners may not be classified as essential Medicaid providers. The agency is to determine which providers are essential Medicaid providers out of the following categories: o Federally qualified health centers. 8 o Statutory teaching hospitals. o Hospitals that are trauma centers. o Hospitals located at least 25 miles from any other hospital with similar services. Plans must include all essential Medicaid providers in the region, unless the agency approves an alternative arrangement. If a managed care plan has not contracted with all essential providers in the region, the plan must negotiate in “good faith” for one year or until an agreement is reached. Payments for services rendered by a non-participating essential provider shall be made at the applicable Medicaid rate as of the first day of the contract between the agency and the plan. After one year, managed care plans that are unable to contract with essential providers must notify the agency and propose an alternative arrangement. If the arrangement is approved by the agency, payments to non-participating essential providers shall equal 90 percent of the applicable Medicaid rate. If the arrangement is not approved, payments shall equal 110 percent of the applicable Medicaid rate. Certain providers are considered statewide resources and essential providers for all managed care plans in all regions. All managed care plans are required to include the following essential providers in their networks: o Faculty plans of Florida medical schools. o Regional perinatal intensive care centers. o Hospitals licensed as specialty children’s hospitals. o Accredited and integrated systems serving medically complex children that are comprised of separately licensed, but commonly owned, health care providers delivering at least the following services: Medical group home. In-home and outpatient nursing care and therapies. Pharmacy services. Durable medical equipment. Prescribed pediatric extended care. A managed care plan that has not contracted with all statewide essential providers must continue to negotiate in good faith. Payments to physicians on the faculty of non-participating Florida medical schools shall be made at the applicable Medicaid rate. Payments for services rendered by a regional perinatal intensive care center shall be made at the applicable Medicaid rate as of the first day of the contract between the agency and the plan. 9 Payments to non-participating specialty children’s hospitals shall equal the highest rate established by contract between the provider and any other Medicaid managed care plan. After 12 months, a plan can exclude any essential provider that does not meet the plan’s quality or performance standards. The agency shall establish a base reimbursement rate for each hospital, calculated annually. Hospitals lobbied hard to have rates calculated twice a year. The agency is required to develop a plan to convert inpatient hospital rates to a prospective payment system that categorizes each case into diagnosis-related groups and assigns a payment weight based on the average resources used to treat Medicaid patients in that DRG. The agency shall contract with a single organization representing medical schools and GME programs in the state for the purpose of establishing an active and ongoing program to improve clinical outcomes in all managed care plans. Each managed care plan shall monitor the quality and performance of each participating provider, and notify all network providers of the metrics used by the plan. The agency shall contract with an administrative services organization representing all Healthy Start coalitions providing risk-appropriate care coordination. Each managed care plan shall establish specific programs and procedures to improve pregnancy outcomes and infant health. After the end of the second contract year, each managed care plan shall achieve an annual early and periodic screening, diagnosis, and treatment service-screening rate of at least 80 percent. Each managed care plan must accept any medically needy recipient who selects or is assigned to the plan, and provide the recipient with continuous enrollment for 12 months. Each plan shall establish and maintain an accurate and complete electronic database of contracted providers. This database must be available online to the public. Each plan’s prescribed drug formulary or preferred drug list must be on the plan’s website and accessible to and searchable by enrollees and providers. Managed care plans must accept prior authorization requests for any service electronically. AHCA must maintain and operate a Medicaid Encounter Data System regarding covered services provided to all Medicaid recipients. AHCA shall analyze the data to identify possible instances of inappropriate denial of claims, overutilization, etc. The agency shall establish specific performance standards and timelines for improving performance. Each managed care plan shall establish an internal health care quality improvement system, including enrollee satisfaction and disenrollment surveys. 10 Each plan shall establish program integrity functions and activities to reduce the incidence of fraud and abuse, including: (1) a provider credentialing system and ongoing monitoring; (2) an effective pre-payment and post-payment review process; (3) procedures for reporting instances of fraud and abuse; (4) a mandatory compliance plan; and (5) designation of a program integrity compliance officer. Managed care plans that reduce enrollment levels or leave a region before the end of the contract term must reimburse the agency for the cost incurred and pay a per-enrollee penalty of up to three months’ payment. The plan must continue to provide services for 90 days, or until the enrollee joins another plan. The plan must provide 180-day notice before withdrawing from a region. The FMA was successful in inserting a provision that requires all Medicaid managed care plans to comply with the prompt payment provisions the FMA passed several years ago in the commercial HMO context. A PSN must ensure that a hospital with a controlling interest in the PSN does not charge a managed care plan more than the amount paid to the hospital by the PSN. Provides that disputes between a provider and a managed care plan may be resolved by the statewide provider and health plan claim dispute resolution program. AHCA shall conduct a full financial audit of each managed care plan in order to verify the achieved savings rebate. An achieved savings rebate is payable as follows: o One hundred percent of income up to and including 5 percent of revenue shall be retained by the plan. o Fifty percent of income above 5 percent and up to 10 percent shall be retained by the plan, and the other 50 percent refunded to the state. o One hundred percent of income above 10 percent of revenue shall be refunded to the state. A plan that exceeds agency-defined quality measures may retain an additional 1 percent of revenue. A number of items may not be included as allowable expenses in calculating income, such as lobbying expenses. Each Medicaid recipient shall have a choice of plans and may select any available plan not restricted by contract to a specific population. Recipients have 30 days in which to make a choice of plans. After enrolling, a recipient has 90 days to dis-enroll and select another plan. After 90 days, no further changes can be made except for good cause. Medicaid recipients who do not choose a plan shall be enrolled automatically into a managed care plan by the agency, using set criteria. 11 The agency is required to develop a process to enable a Medicaid recipient with access to employer-sponsored health care coverage to opt out of all managed care plans, and to use Medicaid financial assistance to pay for the recipient’s share of the cost. If federally approved, the agency shall let other recipients with access to other insurance (including the Florida Health Choices program) opt out, as long as the financial assistance provided does not exceed the amount of the Medicaid premium that would have been paid to a managed care plan. The agency is required to seek federal approval to develop a cost-sharing system or premium payment requirement for certain patients whose household income is greater than 100 percent of the FPL. The agency is also required to seek federal approval for a requirement that Medicaid recipients pay a $100 co-payment for non-emergency services and care furnished in a hospital emergency department. Beginning with the 2014-2015 fiscal year, AHCA may accept voluntary transfers of local taxes and other qualified revenue from counties, municipalities, and special taxing districts (Intergovernmental Transfers or IGTs). These funds may be used for the Low-Income Pool (LIP), which is created to compensate a certain network of providers, and must be used to support enhanced access to services by offsetting shortfalls in Medicaid reimbursement, paying for otherwise uncompensated care, and financing coverage for the uninsured. Persons eligible for the “Medically Needy” program shall enroll in managed care plans. Certain individuals are exempt from mandatory managed care enrollment. They include: o Medicaid recipients who have other creditable health coverage, excluding Medicare. o Medicaid recipients residing in residential commitment facilities or mental health treatment facilities. o Persons eligible for refugee assistance. o Medicaid recipients who are residents of a developmental disability center. o Medicaid recipients enrolled in the home and community based services waiver. Those who choose not to enroll shall be served in the Medicaid fee-for-service program. Each plan shall establish a program to encourage and reward healthy behaviors (smoking cessation, weight loss, etc.). Each plan shall establish a program to encourage enrollees to establish a relationship with their primary care provider. The agency may not pay for psychotropic medication prescribed for a child in the Medicaid program without the express and informed consent of the child’s parent or legal guardian. 12 Medicaid recipients diagnosed with HIV/AIDS residing in Broward, Miami-Dade, or Palm Beach Counties shall be assigned to a specific Medicaid HMO. Medicaid eligibility is restricted to U.S. citizens and certain lawfully admitted non-citizens. State funds may not be used to provide services for non-eligible individuals unless the services are necessary to treat an emergency medical condition or are provided for pregnant women. The agency may establish a per-member, per-month payment for Medicare Advantage Special Needs members who are also eligible for Medicaid. The agency may also develop a per-member, per-month payment only for Medicaid covered services for which the state is responsible. On a case-by-case basis, the agency may exempt a recipient from mandatory enrollment in a managed care plan when the recipient has a unique, time-limited disease and managed care enrollment will interfere with ongoing care because the recipient’s provider does not participate in the managed care plans in the area. AHCA shall begin implementation of the statewide managed medical assistance program by Jan. 1, 2013, with full implementation in all regions by Oct. 1, 2014. Out of left field, the FMA was hit early in the session with a legislative bomb backed by the National Rifle Association, one of the most powerful lobbying organizations in Tallahassee. As initially filed, HB 155 by Rep. Jason Brodeur (SB 432 by Sen. Greg Evers) would have made any inquiry of a patient regarding the ownership of a firearm a violation of the patient’s right to privacy, and would have prohibited the condition of providing medical treatment on a patient’s willingness to disclose personal and private information unrelated to medical treatment. Furthermore, a physician would have been prohibited from putting information concerning firearms into the patient’s medical records, or disclosing such information to any other source. A physician who violated any of these provisions would have been guilty of a third-degree felony and subject to a $5 million fine. The FMA strongly opposed this bill as filed, and worked relentlessly to kill it in committee. After losing in the House Criminal Justice Subcommittee, and at the urging of House and Senate leadership, the FMA reached a compromise with the NRA that provided a measure of comfort for gun owners while preserving the physician-patient relationship. This compromise represented a significant victory for the FMA and the physicians of Florida. While a few physician groups opposed the compromise, misinformation has been circulating, and it is important to clarify what the final version of the bill does and does not do. The bill does: 13 Prohibit any health care practitioner or hospital from intentionally entering non-relevant information concerning firearm ownership into a patient’s medical record. The bill does NOT: Prevent a physician from entering information concerning firearm ownership into the patient’s medical record if, according to the physician, the information is relevant to the patient’s medical care or safety, or the safety of others. For example, a physician who treats a suicidal patient would be able to note in the medical record that the patient was asked and admitted to owning a gun. The bill does: Provide that a health care practitioner and hospital shall respect a patient’s right to privacy and should refrain from asking or making a written inquiry about whether the patient owns a firearm, or whether there is a firearm in the patient’s or family member’s house. However: The FMA inserted language that significantly modifies the general rule above, and provides that a physician who, in good faith, believes that information regarding firearm ownership or the presence of a firearm in the home is relevant to the patient’s medical care or safety, or the safety of others, may make such a verbal or written inquiry. This will allow pediatricians to engage in anticipatory guidance with their patients about firearm safety. Physicians will be able to ask patients if they own firearms in order to counsel them about gun safety. Psychiatrists and other physicians treating patients with suicidal tendencies will be able to ask whether a patient owns a firearm. Simply put, if the physician believes that firearm ownership information is relevant to the patient’s medical care and safety, the physician can ask all the questions he or she wishes. The bill does: Allow a patient to decline to answer or provide any information regarding gun ownership. The bill does NOT: Alter existing law regarding a physician’s authorization to choose his or her patients. If the physician decides that the failure to answer firearm-related questions is detrimental to the patient’s care, the physician can choose not to see the patient. The bill does: 14 Provide that a health care practitioner and a hospital may not discriminate against a patient based ONLY on the patient’s exercise of the constitutional right to own and possess a firearm. Provide that health care practitioners and hospitals shall respect a patient’s right to own a firearm. The bill does NOT: Make it a felony (or any criminal penalty whatsoever) to ask about firearms or document such in the patient’s medical records. Impose large civil fines for any violation of any provision in the legislation. The bill does: Give the sole authority to the Board of Medicine to enforce the provisions of this legislation. HB 935 by Rep. Richard Corcoran (SB 1410 by Sen. Joe Negron) is referred to as the “health care price transparency bill,” and sets forth different requirements for various health care providers relating to the posting of prices for health care services. Primary care physicians are not required to but may publish a schedule of charges for their 50 most frequently provided services. If a physician chooses to do so, the posting must be at least 15 square feet in size and include the prices charged to an uninsured cash pay patient. Physicians who choose to post their prices receive a one-time exemption from having to pay the license renewal fee and receive a single two-year exemption from all CME requirements. Accepting these exemptions will require the physicians to continually post their prices for as long as they are in active practice. Those who fail to do so will have to pay the exempted fee and make up the skipped CMEs. Urgent care centers, defined as facilities or clinics that provide immediate but not emergent ambulatory medical care to patients with or without an appointment, must publish a schedule of charges for cash pay patients. Failure to do so shall result in a fine of not more than $1,000 per day, until the schedule is published and posted. Unlike primary care physicians, urgent care centers receive nothing for posting their prices. While an “urgent care center” is defined in statute, there is no requirement that such an entity obtain a separate license. Thus, it is unclear as to what entity will enforce this requirement. 15 Health care clinics that are licensed under part X of chapter 400 also must post their prices for cash pay patients. The fine is the same as for urgent care centers, and no benefit is provided. In addition, an entity that meets an exemption from having to be licensed as a health care clinic, and applies for a certificate of exemption, must also post prices for cash pay patients. The mandatory requirements for urgent care centers and health care clinics make no sense, but unfortunately were slipped into the bill during the last week of session, after the FMA had agreed to different language that would not have made it a mandatory obligation for health care clinics and non-hospital owned urgent care centers. OTHER SUCCESSFUL LEGISLATION MONITORED BY THE FMA HB 1085 by Rep. Scott Plakon (SB 1282 by Sen. Ronda Storms) is the “Kelly Smith Gynecologic and Ovarian Cancer Education and Awareness Act.” This bill encourages all health care providers to disseminate and display information about gynecologic cancers, including the signs and symptoms, risk factors, benefits of early detection through appropriate diagnostic testing, and treatment options. It also requires the Surgeon General to make gynecologic cancer information publicly available. There were several abortion-related bills that passed this session. HB 1127 by Rep. Elizabeth Porter (SB 1744 by Sen. Ronda Storms) provides that the probable gestational age of the fetus must be verified by an ultrasound, performed by the physician who is to perform the abortion, and an opportunity to view the ultrasound must be offered to the woman along with an explanation of the ultrasound images. There are exceptions for victims of rape, incest, etc. Failure to comply is grounds for discipline by the Board of Medicine. HJR 1179 by Rep. Dennis Baxley (SB 1538 by Sen. Anitere Flores) proposes a constitutional amendment, to be approved by the voters, that would prohibit the use of public funds for any abortion or for health-benefits coverage that includes coverage of abortion (with certain exceptions). HB 97 by Rep. Matt Gaetz (SB 1414 by Sen. Stephen Wise) provides that a health insurance policy purchased with any state or federal funds through an exchange created by the Patient Protection and Affordable Care Act may not provide coverage for an abortion except in certain circumstances. 16 HB 5303, a conforming bill, reduced the amount of revenue from the Health Care Trust Fund reserved for research of tobacco-related or cancer-related illnesses from $50 million to $25 million. Of this amount, $5 million is to be appropriated to each of the following: James and Esther King Biomedical Research Program William G. “Bill” Bankhead, Jr., and David Coley Cancer Research Program H. Lee Moffitt Cancer Center and Research Institute Sylvester Comprehensive Cancer Center of the University of Miami University of Florida Shands Cancer Center SB 702 by Sen. Anitere Flores (HB 471 by Rep. Jeanette Nuñez) requires the Department of Health to make publicly available on its website materials relating to umbilical cord blood developed by the Parent’s Guide to Cord Blood Foundation. The Department shall encourage physicians who provide pregnancy services to make available information on the options regarding umbilical cord blood banking. Health care providers who comply with this bill’s provisions are not liable for civil damages, criminal penalties, or administrative discipline. HB 445 by Rep. Clay Ingram (SB 1522 by Sen. Don Gaetz) allows health insurers and HMOs to offer a voluntary wellness or health improvement program and to encourage participation in the program by offering rewards or incentives to members. SB 450 by Sen. Mike Bennett (HB 215 by Rep. Joe Abruzzo) is the “Post-disaster Relief Assistance Act.” This act provides that anyone who gratuitously provides temporary housing, food, water, or electricity to emergency first responders (which, by definition, includes physicians) in a declared state of emergency may not be held liable for civil damages unless the person acts in a manner that demonstrates a reckless disregard for the consequences of another. Unfortunately, “reckless disregard” is given the standard trial bar-approved definition, and provides little actual protection. BILLS OPPOSED BY THE FMA THAT DID NOT PASS SB 1892 Relating to Health Care by Sen. Mike Bennett – This bill purposely combined a scope-ofpractice expansion for optometrists and ARNPs with medical liability reforms sought by the FMA. While the FMA certainly appreciates Sen. Bennett’s efforts to assist with medical liability reform, allowing optometrists to prescribe oral medications and allowing ARNPs to prescribe controlled substances is inimical to public safety. The FMA was successful in defeating the bill in the Senate Health Regulation Committee and was able to pass many of the medical liability reform provisions in HB 479. 17 HB 4103 Relating to Medical Practice by Rep. Daphne Campbell (SB 2038 by Sen. Oscar Braynon) – This bill would have repealed the physician supervision requirements of ARNPs, undoing important legislation the FMA passed in 2006. HB 4207 Relating to Damages for Wrongful Death by Rep. Darryl Rouson – This bill would have repealed the provisions relating to the prevention of recovery of damages for wrongful death by adult children of a decedent. HB 967 Relating to Personal Injury Protection Insurance by Rep. Mike Horner; HB 1411 Relating to Motor Vehicle Personal Injury Protection Insurance by Rep. Jim Boyd – The automobile insurance industry has worked for years to pass legislation that would skew the rules regarding personal injury protection insurance in their favor under the rationale that their legislation would address the fraud and abuse problem in PIP. The FMA has supported numerous anti-fraud provisions in PIP throughout the years that were truly anti-fraud. Unfortunately, the original provisions in HB 967 and HB 1411 did not just address fraud, but would have made it extremely difficult for a physician to receive fair compensation for treating an auto accident patient, and thus, both bills were opposed by the FMA. Reps. Horner and Boyd worked extremely hard to come up with a compromise that would fight fraud without giving the auto insurance companies carte blanche to engage in abusive payment practices without recourse. The two bill sponsors merged the acceptable provisions in their bills, along with provisions requested by the FMA, into a proposed committee substitute that wound up failing in the House Health and Human Services Committee by an 8-9 vote. SB 1694 Relating to Motor Vehicle Personal Injury Protection Insurance by Sen. Garrett Richter; SB 1930 Relating to Motor Vehicle Personal Injury Protection Insurance by Sen. Ellyn Bogdanoff – These bills would have enacted limits on the attorney’s fee awards related to disputes under the Florida Motor Vehicle No-Fault law and would have placed burdensome new provisions on physicians who treat auto accident patients. (See the explanation of HB 967.) HB 1067 Relating to Death and Fetal Death Registration by Rep. Debbie Mayfield (SB 1544 by Sen. Dennis Jones) – This bill, defeated by the FMA, would have allowed physician assistants and advanced registered nurse practitioners to provide certification of death or fetal death under certain conditions. HB 25 Relating to Mammogram Reports by Rep. Elaine Schwartz (SB 96 by Sen. Jeremy Ring) – This bill would have required that all mammography reports include information and notice about breast density. 18 HB 115 Relating to the Creation of the Department of Health and Human Services by Rep. Janet Adkins (SB 528 by Sen. Steve Oelrich) – This bill would have created the Florida Department of Health and Human Services (DHHS), thereby repealing provisions relating to DCFS, AHCA, DOH, and related trust funds and transferring those agencies’ related functions and responsibilities to DHHS. SB 356 Relating to the Practice of Optometry by Sen. Larcenia Bullard – This bill would have authorized certified optometrists to administer and prescribe oral medications. HB 497 Relating to Pharmacy by Rep. Patrick Rooney, Jr. – This bill would have prohibited the opening, etc., of a pharmacy within a 10-mile radius of a pain-management clinic, and would have prohibited dispensing practitioners who own, operate, or are employed by certain painmanagement clinics from dispensing at certain locations specified controlled substances prescribed for patients at such clinics. HB 585 Relating to Pharmacy by Rep. Doug Broxson (SB 1268 by Sen. Steve Oelrich) – This bill, defeated by the FMA, would have permitted pharmacists to administer additional vaccines including influenza vaccines, varicella zoster vaccine, pneumococcal vaccine, and epinephrine, via an autoinjector delivery system. HB 793 Relating to Infant Eye Care by Rep. Mark Pafford (SB 1056 by Sen. Maria Sachs) – This bill would have required certain eye examinations for all infants born in a Florida hospital. OTHER BILLS THAT DID NOT PASS HB 21 Relating to Health Insurance by Rep. Ari Porth (SB 180 by Sen. Eleanor Sobel) – This bill would have required all antiretroviral agents to be included on health plan formularies while also prohibiting access-limiting procedures used to restrict antiretroviral agents prescribed to treat persons with HIV and including reference to such requirements on policies issued by out-of-state groups. HB 79 Relating to the Use of Wireless Communications Devices While Driving by Rep. Ari Porth (SB 158 by Sen. Nancy Detert) – This bill would have created the “Florida Ban on Texting While Driving Law," which would prohibit the operation of a motor vehicle while using wireless communications. SB 100 Relating to Autism by Sen. Ring (HB 1431 by Rep. Bill Hager) – This bill would have required a physician to refer a minor to an appropriate specialist for screening for autism spectrum disorder under certain circumstances, and would have required that certain insurers and health maintenance organizations provide direct patient access to an appropriate specialist for screening 19 for or evaluation or diagnosis of autism spectrum disorder, and provide a minimum number of visits per year for screening for, or evaluation or diagnosis of autism spectrum disorder, etc. HB 111 Relating to Cadmium in Children’s Products by Rep. Geraldine Thompson (SB 272 by Sen. Arthenia Joyner) – This bill would have prohibited a person from using or applying cadmium in excess of the specified amount on any item of children's jewelry, toy, or child care article sold in this state while also providing exceptions and criminal penalty. SB 118 Relating to Bicycle Safety by Sen. Larencia Bullard (HB 981 by Rep. Janet Cruz) – This bill would have revised the safety standard requirements for bicycle helmets that must be worn by certain riders and passengers. HB 119 Relating to Health Care by Rep. Matt Hudson (SB 1736 by Sen. Jack Latvala) – This bill became the health care “train” bill, which contained numerous unrelated health care provisions such as amending the Health Care Clinic Act to provide additional exemptions, adding orthotic, pedorthic, and prosthetic licensees to the list of “health care providers” for purposes of medical malpractice lawsuits, and revising self-referral exceptions for nurse registries, home health agencies, and group practices. This bill was the vehicle for an extremely controversial provision that would have changed the definition of a “group practice” for purposes of Florida’s self-referral act. This change would have put several urology groups that treat prostate cancer out of business. The FMA, working with the affected group practices, was successful in removing this provision from the bill. SB 152 Relating to Congenital Craniofacial Anomalies by Sen. Larencia Bullard – This bill would have required AHCA, in consultation with the Office of Insurance Regulation, to conduct a study concerning the medical necessity, costs, and efficacy of mandating coverage for certain treatments and therapies and report its findings back to the Legislature. SB 162 Relating to Tanning Facilities by Sen. Eleanor Sobel (HB 1265 by Rep. Elaine Schwartz) – This bill would have prohibited a minor younger than a certain age from using a tanning device at a tanning facility. SB 238 Relating to Child Safety Devices in Motor Vehicles by Sen. Thad Altman (HB 11 by Rep. Richard Steinberg) – This bill would have changed the child-restraint requirements in motor vehicles for children ages 4-7 who are less than a specified height. HB 257 Relating to Financial Responsibility for Medical Expenses of Arrestees, Pretrial Detainees, or Sentenced Inmates by Rep. Ed Hooper (SB 490 by Sen. Dennis Jones) – This bill would have allowed a county or municipality to pay the medical costs of an arrestee, pretrial detainee, or sentenced inmate at 110 percent of the Medicare allowable rate if no formal written agreement 20 exists between the county or municipality and the third-party medical care provider, but exempted payments to physicians for emergency services provided within a hospital emergency department from the maximum allowable rate. HB 301 Relating to Youth Athletes by Rep. Ronald Renuart (SB 730 by Sen. Anitere Flores) – This bill would have required the independent sanctioning authority and the FHSAA to adopt bylaws or policies that require an athlete who is suspected of sustaining a concussion or head injury to be removed from practice or competition until the athlete receives written clearance to return from a physician or osteopathic physician. Rep. Renuart, strongly supported by the FMA, refused to accept changes made by the Senate on the last day of session that would have allowed chiropractors to clear students with a head injury to return to play. HB 321 Relating to Abortion by Rep. Carlos Trujillo – This bill would have required a physician to offer to administer anesthetic or analgesic to a fetus if an abortion is to be performed on a fetus whose gestational age is 22 weeks or more. HB 323 Relating Breast Cancer Early Detection and Treatment Referral Program by Rep. Janet Cruz (SB 802 by Sen. Maria Sachs) – This bill revises the criteria of a breast cancer early detection and treatment referral programs to require that public education, outreach initiatives, and professional education programs use guidelines currently employed by the U.S. Centers for Disease Control and Prevention rather than U.S. Preventive Services Task Force. SB 334 Relating to Controlled Substances by Sen. Mike Fasano – This bill would have required a person who knows, or has reasonable cause to suspect, that a health care practitioner who prescribes or dispenses controlled substances is stealing or abusing controlled substances that have been prescribed or dispensed for another to report such knowledge or suspicion to a law enforcement agency, etc. The FMA worked with Sen. Fasano to soften the impact of this bill, but it never received a hearing. SB 350 Relating to Insurance Coverage for Colorectal Cancer Screening by Sen. Eleanor Sobel – This bill would have required certain health insurance policies, health maintenance organization contracts, health insurance programs, group arrangements, and managed health care delivery entities providing coverage to state residents to provide coverage for certain colorectal cancer examinations and laboratory tests for colorectal cancer. HB 391 Relating to Expert Testimony by Rep. Larry Metz (SB 822 by Sen. Ellyn Bogdanoff) – This bill would have changed the standard for the admission of expert testimony in Florida from the current Frye standard to the Daubert standard used in federal cases and many states. 21 HB 393 Relating to the Regulation of Professions by Rep. Daniel Davis (SB 1742 by Sen. John Thrasher) – This bill was the PRN reviser bill. HB 415 Relating to Abortion by Rep. Charles Van Zant – This bill would have regulated the practice of abortions in various ways, including prohibiting induced abortions, prohibiting the termination of pregnancy unless specified conditions are met, requiring consent, providing that a woman's life is superior to concern for life of fetus, and requiring that fetal remains be disposed of according to specified standards. HB 505 Relating to Health Care Coverage by Rep. Dennis Jones (SB 1882 by Sen. Rene Garcia) – This bill would have required health insurers, corporations, and health maintenance organizations to issue certain health policies to provide coverage for telemedicine services. HB 549 Relating to Eye Care Professionals by Rep. John Tobia (SB 868 by Sen. Eleanor Sobel) – This bill would have revised the membership requirements for the Board of Optometry and revised the duties of and restrictions on the practice of optometry by non-licensed supportive personnel. HB 623 Relating to Emergency Health Care Providers by Rep. Ronald Renuart – This bill would have provided sovereign immunity to certain health care providers. SB 742 Relating to Surgical First Assistants by Sen. Eleanor Sobel – This bill would have established the duties, scope, and location of practice for certified surgical first assistants. HB 763 Relating to High School Athletic Trainers by Rep. Patrick Rooney, Jr. (SB 1176 by Sen. Jeremy Ring) – This bill would have required certain continuing education for licensed athletic trainers on the prevention and emergency management of concussions, catastrophic spinal cord, neck, and brain injuries, and also would have required school districts to employ at least one fulltime certified athletic trainer at each high school in the state. HB 779 Relating to Restraint of Incarcerated Pregnant Women by Rep. Betty Reed (SB 1086 by Sen. Tony Hill) – This bill would have prohibited the use of restraints on prisoners known to be pregnant during labor, delivery, and postpartum recovery unless corrections officials made individualized determinations that a prisoner presented extraordinary circumstances requiring restraints. SB 810 Relating to Pain-Management Clinics by Sen. Mike Fasano (HB 1147 by Rep. Luis Garcia) – This bill would have created specific standards of practice in pain-management clinics with 22 regards to evaluations of a patient's medical diagnosis, treatment plans, informed consent, agreements for treatment, a physician's periodic review of a patient, consultation, patient drug testing, patient medical records, denial or termination of controlled-substance therapy, facility and physical operations, infection control, health and safety, quality assurance, and data collection and reporting. SB 892 Relating to Pain-Management Clinics by Sen. Charles Dean – This bill would have authorized counties and municipalities to adopt certain regulations of pain-management clinics. SB 1064 Relating to Practice of Surgical Technology by Sen. Evelyn Lynn (HB 1197 by Rep. Ronald Renuart) – This bill would have prohibited a person from practicing surgical technology in a health care facility unless he or she met certain criteria. HB 1185 Relating to Pain-Management Clinics by Rep. Paige Kreegel (SB 1238 by Sen. Mike Fasano) – This bill would have provided that persons who are convicted of, enter plea of guilty or nolo contendere to, or have adjudication withheld for knowingly operating, owning, or managing unregistered pain-management clinic are subject to the Florida Contraband Forfeiture Act. HB 1187 Relating to Civil Remedies Against Insurers by Rep. Dennis Baxley (SB 1592 by Sen. John Thrasher) – This bill would have changed the laws regarding “bad faith” actions against insurance companies. SB 1200 Relating to Treatment of Stroke by Sen. Dennis Jones (HB 1061 by Rep. James Waldman) – This bill would have required AHCA to establish the Stroke Task Force and would have required primary and comprehensive stroke centers and certain medical facilities to report certain data regarding stroke patients to a private, tier-one research university in this state. HB 1237 Relating to Legal and Medical Referral Service Advertising by Rep. Rick Kriseman (SB 1918 by Sen. Gwen Margolis) – This bill would have required advertising from medical or lawyer referral services related to motor vehicle accidents to comply with certain requirements regarding content, etc. HB 1338 Relating to Contraception by Sen. Nancy Detert – This bill would have required that health insurers and health maintenance organizations provide health insurance coverage for prescription contraceptive drugs and devices approved by the Food and Drug Administration, and other related outpatient contraceptive services. SB 1748 Relating to Abortions by Sen. Anitere Flores (HB 1397 by Rep. Rachel Burgin) – This bill would have restricted the circumstances in which an abortion may be performed in the third trimester or after viability. It also would have required an abortion clinic to provide conspicuous 23 notice on any form or medium of advertisement that the abortion clinic is prohibited from performing abortions in the third trimester or after viability. The Florida Medical Association – particularly the legislative team – put a tremendous amount of work this session into significantly improving and protecting your ability to practice. These victories would not have come to pass without the FMA PAC’s efforts throughout the year to help pro-medicine candidates get elected to the Legislature. The proof is in the results. 24