LEGISLATIVE UPDATE

The 2004 Session ended on time with the Legislature passing 500 bills. In this year's legislation, all areas of healthcare were impacted including practitioners, hospitals, nursing homes, health clinics, pharmacies, and health maintenance organizations. The following summary highlights significant changes to existing regulation.

Medicinal Drug Prescriptions - House Bill 103

The bill requires a prescription written by a practitioner, who is authorized under the laws of Florida to write prescriptions for drugs that are not controlled substances, but who is not eligible for a federal drug enforcement administration number, to include that practitioner's name and professional license number. The pharmacist or dispensing practitioner must include the practitioner's name on the container of the drug that is dispensed.

A prescription written by a Florida-licensed advanced registered nurse practitioner or physician assistant for a drug that is not a controlled substance is presumed, subject to rebuttal, to be valid and within the parameters of the prescriptive authority delegated to the advanced registered nurse practitioner or physician assistant who is prescribing the drug. For purposes of the presumption, the prescriptive authority must be delegated to the advanced registered nurse practitioner by a Florida-licensed medical physician, osteopathic physician, or dentist, and in the case of a physician assistant, the prescriptive authority must be delegated by the physician assistant's supervising physician.

These provisions were approved by the Governor and take effect July 1, 2004.

Genetic Counseling Practice Act - Senate Bill 506

The bill provides for the regulation of genetic counseling in Florida by the Board of Genetic Counselors in the Department of Health. The practice of genetic counseling means, for remuneration, the communication process that deals with the human problems associated with the occurrence, or the risk of occurrence, of a genetic disorder in a family, including the provision of services to help an individual or family:

 Comprehend the medical facts;

 Appreciate the way heredity contributes to the disorder;

 Choose the course of action which seems appropriate and act in accordance with that decision; and

 Make the best possible psychosocial adjustment.

In providing for the regulation of genetic counseling, the bill provides legislative intent, definitions, requirements for licensure, exemptions, rulemaking authority for the newly created 5-member Board of Genetic Counselors, requirements for membership and appointment to the board, and fees.

Good Samaritan Act - Senate Bill 532

The bill extends immunity from civil liability, under the Good Samaritan Act, to a person who gratuitously provides care, treatment, or service during emergency response activities in connection with a community emergency response team, local emergency management agencies, the Division of Emergency Management of the Department of Community Affairs, or the Federal Emergency Management Agency. The immunity also protects a person from civil liability far damages caused by an act or a failure to act to arrange further care, treatment, or services if such person acts as a reasonably prudent person would have acted under the same or similar circumstances.

Anesthesiologist Assistants - Senate Bill 626

The bill provides for the licensure of anesthesiologist assistants under the regulatory jurisdiction of the Board of Medicine or the Board of Osteopathic Medicine, and for joint rulemaking by these boards for aspects of the practice of this profession. The regulation would allow an anesthesiologist assistant to practice within the framework of a protocol under the direct supervision of a supervising anesthesiologist or group of anesthesiologists. "Direct supervision" is defined to mean the on-site, personal supervision by an anesthesiologist who is present in the office when the procedure is being performed in that office, or is present in the surgical or obstetrical suite when the procedure is being performed in that surgical or obstetrical suite and who is in all instances immediately available to provide assistance and direction to the anesthesiologist assistant while anesthesia services are being performed.

Internet Pharmacies - Senate Bill 1372

The bill requires an "Internet pharmacy" to receive a permit in order to sell medicinal drugs to persons in Florida. The bill requires any person who desires to operate an Internet pharmacy to apply to the Florida Department of Health (DOH) for an Internet pharmacy permit. The bill defines "Internet pharmacy" to include locations not otherwise licensed or issued a pharmacy permit, within or outside Florida, which use the Internet to communicate with or obtain information from consumers in Florida and use such communication or information to fill or refill prescriptions orto dispense, distribute, or otherwise engage in the practice of pharmacy in Florida.

A permit may not be issued to an "Internet pharmacy" unless a licensed pharmacist is designated as the prescription department manager for dispensing medicinal drugs to persons in Florida. The bill requires the Internet pharmacy and the pharmacist designated by that pharmacy to serve as prescription department manager or its equivalent to be licensed in the state of location in order to dispense drugs in Florida. For additional information concerning this bill, see "Internet Pharmacies", Page 5.

Certificate of Need - Senate Bill 182

This bill provides an exemption from certificate-of-need (CON) review for the provision of percutaneous coronary intervention for patients presenting with emergency myocardial infarctions in a hospital that does not have an approved adult open-heart surgery program.

The bill directs the Secretary of Health Care Administration to appoint an advisory group to study the issue of replacing CON review of organ transplant programs and requires the advisory group to submit a report to the Governor, the Secretary of Health Care Administration and the Legislature by July 1, 2005. The legislation also directs the Secretary of Health Care Administration to appoint a work group to study certificate-of-need regulations and changing market conditions related to the supply and distribution of hospital beds and requires the work group to submit a report to the Secretary and the Legislature by January 1, 2005.

Open Heart Surgery/Certificates of Need - House Bill 329

This bill revises various provisions relating to the certificate-of-need (CON) program to decrease the regulation of certain health care services. Significant changes include allowing most hospitals to add acute care beds without CON review and making adult cardiac services a licensed activity not subject to CON review.

The bill directs the Secretary of Health Care Administration to appoint an advisory group to study the issue of replacing CON review of organ transplant program and requires the advisory group to submit a report to the Governor, the Secretary of Health Care Administration and the Legislature by July 1, 2005. The legislation also directs the Secretary of Health Care Administration to appoint a work group to study certificate-of-need regulations and changing market conditions related to the supply and distribution of hospital beds and requires the work group to submit a report to the Secretary and the Legislature by January 1, 2005.

Health Maintenance Organization Provider Contracts - Senate Bill 1088

This bill requires a health maintenance organization (HMO) that has a contract with a health care provider to disclose to the provider the complete schedule of all reimbursements for which the HMO and the provider of health care services have contracted, including any deviations from the contracted schedule of reimbursements requested by the HMO and agreed upon by the provider of the health care services. The bill:

 Establishes two ways that an HMO may provide the schedule of reimbursements to providers--by electro means or in writing.

 Clarifies that the schedule of reimbursements is subjectto the nondisclosure provisions of the contract, and the provider must maintain the confidentiality of the schedule.

Health Care Facilities - Senate Bill 1062

Nursing Homes

The bill creates a procedure for the issuance of an inactive license for a nursing home to permit a home to maintain its license under two circumstances: during a period when it is temporarily not serving residents but will resume doing so, or when the nursing home will use a contiguous portion of its facility for other services to meet the long-term care needs of elderly residents.

Health Care Clinics

Senate Bill 1062 revises licensure requirements for health care clinics to exempt the following entities from licensure:

- End-stage renal disease providers;

- Therapy providers (speech, occupational, and physical) which are Medicare-ce

- Birth centers;

- Clinical laboratories;

- Charitable clinics - 501(c)(3) or (4);

- Entities owned or operated by the federal or state government;

- Hospitals and entities they own;

- A sole proprietorship, group practice, partnership, or corporation that provides health care services by physicians covered under s. 627.419, F.S. (includes dentists, optometrists, podiatrists; chiropractors, physicians);

- Entities that provide only oncology or radiation therapy services by physicians; and

- Entities that provide neonatal or pediatric hospital-based healthcare services.

Mobile clinics and portable equipment providers are included in the definition of clinic.

Assisted Living Facilities

Assisted Living Facilities are required to conduct resident elopement-prevention drills at least two times per year.

Affordable Health Care - House Bill 1629

This legislation may be referred W as "The 2004 Affordable Health Care for Floridians Act." The purpose of the act is to address the underlying cause of the double-digit increases in health insurance premiums by mitigating the overall growth in health cue coos. The bill includes provisions to improve the availability of affordable health insurance, to provide access to health information regarding costs, and to increase patient safety.

The bill creates the Florida Health Insurance Plan as the high risk pool for uninsurable medical risks, to replace the Florida Comprehensive Health Association (FCHA). The Florida Patient Safety Corporation is created as a not-for-profit corporation to assist health care providers improve the quality and safety of health can that is rendered and reduce harm to patients. In the fulfillment of its purpose, the corporation must work with a consortium of patient safety centers and other patient safety programs in universities in Florida.

Health Care Providers - House Bill 1121

The bill amends the Access to Health Care Act, which extends sovereign immunity to health care providers who execute a contract with a governmental contractor and who provide volunteer, uncompensated health care services to low-income individuals as an agent of the state. The definition of "contract" is revised to provide that for a service to qualify as a volunteer, uncompensated service, the health care provider may not receive any compensation from the governmental contractor for any service rendered to low-income persons and the provider may not bill or accept any compensation from the recipient or any third-party payor for services rendered under the contract. The definition of "health care provider" is revised to include a "free clinic" that delivers only medical diagnostic services or non-surgical medical treatment free of charge to all low-income recipients

The bill extends a waiver of biennial license renewal fees and fulfillment of a maximum of 25 percent of continuing education hours to health care practitioners who participate as a health care provider under the Access to Health Care Act.

Medicaid Fraud - Senate Bill 1064

The bill implements the recommendations from the Senate Select Subcommittee on Medicaid Prescription Drug Over-Prescribing. The bill makes several statutory changes broadening the authority of the Agency for Health Care Administration (AHCA) related to combating fraud and abuse in the Medicaid program, particularly focused on prescription drugs. The bill also makes several statutory changes giving the Medicaid Fraud Control Unit (MFCU) in the Department of Legal Affairs broader authority to pursue entities that try to defraud the Medicaid program.

The bill specifies that a provider is not entitled to enrollment in the Medicaid provider network and that AHCA may implement fee for service provider network controls, including, but not limited to, competitive procurement and provider credentialing.

The bill specifies that AHCA can conduct or contract for prepayment review of provider claims to ensure that billing by a provider is in accordance with applicable Medicaid rules, regulations, handbooks, and policies and in accordance with all state and federal laws, and to ensure that appropriate care is rendered to Medicaid recipients.

The bill specifies a provider's obligation with regard to submitting claims to the Medicaid program by providing that AHCA shall not reimburse any person or entity for any prescription for medications, medical supplies, or medical services if the prescription was written by a physician or other prescribing practitioner who is not enrolled in the Medicaid program.

The bill clarifies that suspension or termination from the Medicare program precludes participation in Medicaid during that period, which includes any action that results in a claim for payment to the Medicaid program as a result of furnishing, supervising a person who is furnishing, or causing a person to furnish goods or services.

The bill authorizes AHCA to withhold payment to a provider upon receipt of evidence of fraud, willful misrepresentation, or abuse under Medicaid, or a crime committed while rendering goods or services to Medicaid recipients, regardless of whether there are ongoing legal proceedings related to that evidence. AHCA is also authorized to deny payments or require repayments where the goods or services were furnished, supervised, or caused to be furnished by a provider terminated or suspended from the Medicaid or Medicare program by the Federal government or any state.

The bill authorizes AHCA to limit the number of Schedule 11 and Schedule III refill prescription claims submitted from pharmacy providers if AHCA or MFCU determines that the specific prescription refill was not requested by the Medicaid recipient or authorized representative for whom the refill claim is submitted, or was not prescribed by the recipient's medical provider or physician.

The bill authorizes the Office of Statewide Prosecution to investigate and prosecute any criminal violation of s. 409.920 or s. 409.9201, F.S., which relate to Medicaid baud. The bill establishes new criminal violations relating to Medicaid fraud and dealing in property paid for by the Medicaid program and expands the definition of "racketeering activity" to include crimes committed under s. 409.9201. F.S., relating to Medicaid recipient fraud. The Statewide Grand Jury's jurisdiction is expanded to include any criminal violation of s. 409.920 or s. 409.9201, F.S., relating to Medicaid fraud.

Public Records Exemption/ Medical Facilities-Senate Bill 464

This bill re-enacts and narrows the public records exemption for public hospitals for the home addresses, telephone numbers, photographs, and names and locations of children s schools and day care facilities of employees who provide direct patient care or security services, and for employees who do not provide direct patient care or security services but who have reason to believe, based upon specific circumstances that have been reported, that release of the information could he used to threaten, or harm them or their families. The home addresses, telephone numbers, and places of employment of the spouses and children of those employees are also exempt. This exemption protects personal information of employees held in public hospitals personnel records.

Public Meetings Exemption/Hospital Board Meetings - Senate Bill 468

This bill re-enacts the public meetings exemption for those portions of a public hospital board meeting at which one or more written strategic plans that are confidential under s. 395.3035(2). F.S., are discussed, modified, or approved by the governing board.