2014 Legislative Session Report

During the 2014 Legislative Session, the Legislature passed a $77.1 billion state budget, and filed 1,812 bills while only passing 264. The number of bills passed this session is almost 22 percent fewer than the ten-year average of 338 bills. The Florida Pharmacy Association along with their legislative advocacy team, Adams St. Advocates (see end of report) were successful in accomplishing all four of FPA’s legislative priorities: fair and uniform pharmacy audit practices, mail order reform, pharmacy technician ratio, and funding for the Prescription Drug Monitoring Program.

SB 702 (Pharmacy Audits), passed both chambers requiring fair and uniform pharmacy audit rules by pharmacy benefit managers’ (PBMs). This new law will provide predictability and common sense business practices for pharmacies to prepare and respond to audits by increasing efficiency and productivity.

Through budget proviso language, state employees will now have the option to purchase their 90 day maintenance drugs from retail pharmacies, instead of being required to only use mail order. This ability to visit and purchase from a retail pharmacy will allow employees better access to care and proper medication counseling.

HB 323 (Pharmacy Technician Ratio), passed both chambers, removing an arbitrary cap and allows the Board of Pharmacy to approve the proper ratio. The Board of Pharmacy makeup was also revised by increasing the number of actively practicing pharmacists to ensure patient safety is a priority in this process. The Board will now include 2 Community Pharmacists (currently practicing), 2 Institutional Pharmacists (currently practicing), 4 at-large pharmacists (any type of practice setting), and 2 consumers (in no way connected to pharmacy).

Due to political dynamics, the House and Senate differed on their approach on how the Prescription Drug Monitoring Program (PDMP) should be accessed. The House and Senate both agreed to fund the PDMP program, however the vehicles in which the funding was included did not pass in the final hours of session. The Attorney General did announce that she will be using $2 million from a past settlement with Caremark to fund the PDMP for four years!

Session began with a series of bills that would have addressed the physician shortage reported across the state. Two separate bills, SB 1352 and HB 1275 (Health Care Practitioners), would have expanded the powers of nurses and physician assistants to allow more independence from supervising physicians. Two other bills, SB 1646 and HB 751 (Telemedicine) would have provided regulation to the state’s budding telemedicine industry and provided health care companies with ways to charge for it. In the last days of the session, the House incorporated all three lower chamber companions into HB 7113 (Health Care Trauma Train), which would have settled a legal dispute that could lead to the closure of three trauma centers.

The massive health care train bill cleared the House and was heavily amended by the Senate to remove any changes to the roles of nurses, physician assistants or the state’s telemedicine industry. Time ran out before the House could take up an amended HB 7113 but in the last hours of the session, the House placed a trauma center provision in an amendment of HB 7105 (Health Care Services Rulemaking) which was rejected in the last moments by the Senate.

Now, the trauma centers dispute will be addressed by the state Department of Administrative Hearings later this month.

OTHER BILLS OF INTEREST THAT WERE ADOPTED BY THE FLORIDA LEGISLATURE:

HB 7177- Relating to OGSR/Department of Health

• Passed unanimously in both House & Senate Chambers
• Open Government Sunset Review Act (OGSR)/Prescription Drug Monitoring Program: Revises provisions relating to public record exemption for certain information held by DOH pursuant to prescription drug monitoring program; specifies that certain entities may disclose confidential & exempt information in certain instances if such information is relevant to active investigation; requires certain steps to ensure continued confidentiality of nonrelevant confidential & exempt information before disclosure of such information; authorizes DOH to disclose relevant information, rather than requiring DOH to disclose confidential & exempt information; saves exemption from repeal. Effective Date: October 1, 2014

HB 7077 – Relating to Nonresident Sterile Compounding Permits

• Passed unanimously in both House & Senate Chambers
• Nonresident Sterile Compounding Permits: Expands penalties to apply to injury to nonhuman animal; deletes requirement that Board of Pharmacy refer regulatory issues affecting nonresident pharmacy to state where pharmacy is located; provides that pharmacy is subject to certain health care fraud provisions; requires registered nonresident pharmacies & outsourcing facilities to obtain permit in order to ship, mail, deliver, or dispense compounded sterile products into this state; authorizes board to deny, revoke, or suspend permit, or impose fine or reprimand for certain actions; provides dates by which certain nonresident pharmacies must obtain permit; authorizes board to adopt rules; authorizes department to inspect nonresident pharmacies & nonresident sterile compounding permittees; requires such pharmacies & permittees to pay for costs of such inspections. Effective Date: October 1, 2014

SB 360 – Relating to Sentencing for Controlled Substance Violations

• Passed unanimously in the Senate and 113 yeas and 2 nays in the House.
• Sentencing for Controlled Substance Violations: Providing that a person who knowingly sells, purchases, manufactures, delivers, or brings into this state, or who is knowingly in actual or constructive possession of, specified quantities of hydrocodone, or any salt, derivative, isomer, or salt of an isomer thereof, or any mixture containing any such substance, commits the offense of trafficking in hydrocodone; providing that a person who knowingly sells, purchases, manufactures, delivers, or brings into this state, or who is knowingly in actual or constructive possession of, specified quantities of oxycodone, or any salt, derivative, isomer, or salt of an isomer thereof, or any mixture containing any such substance, commits the offense of trafficking in oxycodone, etc. Effective Date: 7/1/2014

HB 517 – Relating to Fraudulent Controlled Substance Prescriptions

• Passed unanimously in both House & Senate Chambers
• Fraudulent Controlled Substance Prescriptions: Revises provisions prohibiting possession of incomplete prescription forms; provides enhanced criminal penalties for violations involving incomplete prescription forms. Effective Date: October 1, 2014

SB 836- Relating to Medical Gas

• SB 836 passed the House with 115 yeas and 1 nay, and passed in the Senate with 36 yeas and 0 nays.
• The bill creates part III of ch. 499, F.S., which separates the regulation, including permit requirements, of manufacturers and wholesale distributors of medical gases, as well as medical oxygen retail establishments, from the provisions of part I and part II of the chapter, which regulate the manufacturers and distributors of other drugs, devices, and cosmetics. The bill includes many provisions governing medical gases that are substantially similar to existing provisions in part I, but revises those provisions for applicability to medical gases.

The provisions of new part III require:
o Permits for medical gas manufacturers and wholesale distributors and medical oxygen retail establishments;
o Minimum qualifications for obtaining a permit to deal in medical gases;
o Certain procedures to change a permit;
o Security and storage of medical gases;
o Returned, damaged, and outdated medical gases to be handled in a certain manner;
o Penalties for committing prohibited and criminal acts associated with medical gases; and
o Inspections of facilities that manufacture medical gases.

• The bill requires rules adopted under part III to be consistent with the law and rules governing the possession and use of medical oxygen by emergency medical service providers in part III of ch. 401, F.S.

SB 1030- Relating to Cannabis

• SB 1030 passed the House Chamber with 111 yeas and 7 nays, and the Senate Chamber with 30 yeas and 9 nays.
• SB 1030 names the act, the “Compassionate Medical Cannabis Act of 2014.” This bill changes the definition of low-THC cannabis to mean a plant of the genus Cannabis, the dried flowers of which contain 0.8 percent or less of tetrahydrocannabinol (THC) and more than 10 percent of cannabidiol (CBD) weight for weight; the seeds thereof; the resin extracted from any part of such plant; or any compound, manufacture, salt, derivative, mixture, or preparation of such plant or its seeds or resin that is dispensed only from a dispensing organization.
• The bill expands who may be ordered low-THC cannabis under the act to include a patient suffering from cancer. As a condition of prescribing low-THC cannabis, the physician must determine that no other satisfactory treatment options exist and obtain a voluntary informed consent. The final version of the bill does not include the Senate’s requirement that the physician must have treated the patient for at least 2 months and does not provide for the issuance of a patient identification card.
• Criminal misdemeanor penalties are created for a physician who orders low-THC cannabis for a patient without a reasonable belief that the patient is suffering from a qualifying condition and for any person who fraudulently represents himself or herself as having a qualifying condition for the purpose of obtaining an order for low-THC cannabis.
• A dispensing organization is required to employ a medical director, who must be a physician and have successfully completed a course and examination that encompasses appropriate safety procedures and knowledge of low-THC cannabis. One dispensing organization is authorized in northwest Florida, northeast Florida, central Florida, southeast Florida and southwest Florida, for a total of five statewide. Additional criteria for approval as a dispensing organization include: possessing a certificate of registration for the cultivations of more than 400,000 plants that is issued by the Department of Agriculture and Consumer Services, be operated by a nurseryman, have been operating as a registered nursery in this state for at least 30 years, and provide certified financials. Upon approval, a dispensing organization must post a $5 million performance bond.
• The bill excludes “low-THC cannabis from the definition of cannabis in s. 893.02, F.S.
• Additional emphasis is placed on research in the final version. Medical centers that are recognized as a Cancer Center of Excellence are authorized to conduct research on CBD and low-THC cannabis. The Department of Health’s Office of Compassionate Use is directed to enhance access to investigational new drugs for Florida patients through approved clinical treatment plans or studies, with specific authorities to accomplish this directive. One million dollars is appropriated in nonrecurring general revenue to the James and Esther King Biomedical Research Program for research of CBD and its effect on intractable childhood epilepsy.
• A constitutional amendment allowing doctors to prescribe marijuana to ease the side effects of some debilitating illnesses will be up to Florida voters in November. The ballot initiative is unrelated to SB 1030.

BILLS OF INTEREST THAT WERE NOT ADOPTED BY THE FLORIDA LEGISLATURE:

SB 1014/ HB 765 – Relating to Pharmacy Benefit Managers (MAC Pricing)

• SB 1014 passed through three of the four committees unanimously. There was great discussion and we hope to have this brought up again in the 2015 Legislative Session.
• Pharmacy Benefit Managers; Specifying contract terms that must be included in a contract between a pharmacy benefit manager and a pharmacy; providing restrictions on the inclusion of prescription drugs on a list that specifies the maximum allowable cost for such drugs; requiring a contract between a pharmacy benefit manager and a pharmacy to include an appeal process, etc. Effective Date: 7/1/2014

SB 1266/HB 1361 – Relating to State Employees’ Prescription Drug Program

• Although SB 1266 and HB 1361 failed, we were successful in accomplishing changing the requirement for state employees to use mail order to making it an option between retail pharmacies or mail order through budget proviso language.
• CS/SB 1266 amends s. 110.12315(2), Florida Statutes, relating to the state employees’ prescription drug program, to allow the Department of Management Services to negotiate a dispensing fee for 90-day maintenance drugs at retail, and to authorize a 90-day supply of maintenance prescriptions to be filled at retail. The bill also limits the reimbursement for retail and mail order purchases to the amount contracted by the department for prescriptions fulfilled by mail order.

SB 1646 – Relating to Telemedicine /HB 751 – Relating to Telehealth

• Both SB1646 & HB 751 failed.
• CS/SB 1646 would have created the Florida Telemedicine Act (the act) and defined the key components for the practice of telemedicine. The act establishes telemedicine as the practice of medicine through advanced communications technology by a telemedicine provider at a distant site. A telemedicine provider would be a physician or physician assistant licensed under ch. 458 or ch. 459, F.S., an advanced registered nurse practitioner licensed under ch. 464, F.S., or a pharmacist licensed under ch. 465, F.S., who provides telemedicine services or an out-of-state physician who meets the specific requirements for an exemption from Florida licensure. The standard of care for telemedicine service coincides with health care services provided in- person. A controlled substance may not be prescribed through telemedicine for chronic non- malignant pain. Regulatory boards, or the Department of Health (DOH) if there is not an applicable board, may adopt rules to administer the act. Rules prohibiting telemedicine that are inconsistent with this act must be repealed.
• The bill’s fiscal impact was indeterminate.

SB 1384- Relating to Pharmaceutical Services

• SB 1384 was referred to three committees: Banking and Insurance; Governmental Oversight and Accountability; Appropriations, and later withdrawn from consideration.
• SB 1384 would have created provisions relating to health insurers, and amended provisions relating to health maintenance organizations, to provide that an insured or subscriber may not be required to obtain pharmaceutical services from a mail order pharmacy; providing that a pharmacy that is not a mail order pharmacy is subject to the same terms and conditions as a mail order pharmacy, etc. Effective Date: 7/1/2014