2016 Legislative Session Report
By Michael Jackson, BPharm
Executive Vice President and CEO
|L to R: Representative Travis Cummings, Representative Matt Hudson, FPA’s Michael Jackson and Representative Cary Pigman|
We are again pleased to report another winning legislative session with a number of pharmacy projects presented to members of the Florida legislature for their consideration. With this being a significant election year the possibility to get bills to the Governor’s desk was quite a challenge. There were 937 bills filed in the Florida Senate and 877 bills that were filed in the House. 196 bills passed the Florida Senate and of those bills 116 passed the House as well. The House passed 251 bills and of those 163 passed the Senate as well. This means that of the 1,814 bills that were filed in the House and Senate 279 (15%) were approved in both chambers. As this report is being prepared most of these bills have been signed into law by Governor Rick Scott.
The FPA has been working with the advocacy team of Adams Street Advocates under the leadership of Claudia Davant for the past several years. We have been successful in advancing our proactive policies presented by the Governmental Affairs Committee chaired by FPA member William Garst and approved by the FPA Board of Directors. For 2015-2016 our approved advocacy plan by your Board of Directors was the following:
Advocate for standalone legislation and rulemaking
- FPA should advocate for changes to F.S. 499.0121 that would help to provide relief to pharmacies that are struggling with getting adequate supplies of pain medications to treat their patients.
- Advocate for changes to Florida laws that clarify enforcement and compliance with MAC pricing laws.
- Consider recommended changes to the pharmacy practice act as identified in the draft revisions to F.S. 465.0125 to help pharmacists with patient health and wellness issues and advocate for if an opportunity is presented.
- Continue with efforts to support the national provider status initiatives
- The 3 hour vaccine safety requirements in F.S. 465.009 should allow ACPE providers to deliver this program.
- Advocate for changes in Florida laws to allow pharmacists to dispense a 30 day supply of maintenance medications as current allowed for a 3 day supply when the prescriber cannot be contacted.
Advocate for if opportunity presented
- Registered pharmacy interns should have a designated expiration date. When intern registrations are issued by the Department of Health there is no mechanism in place for them to expire.
Florida currently has laws that low for the limited medical use of cannabis. Current laws and rules to not have a role for Florida licensed pharmacists. Continue to monitor for the development of Florida’s medical marijuana initiatives.
|Michael Jackson Testifies in Senate Health Policy Committee on Network Closures
One of the very critical issues raised by the FPA during the session was related to recent trends where pharmacies were being excluded from provider networks. There were several bills introduced that created a lot of good debate at the Capitol. The Association also published an opinion letter in the Tallahassee Democrat as well as making available to the FPA membership media talking points for both pharmacy owners and consumers on the Pharmview.com web site’s legislative action center. The FPA wishes to thank Senator Aaron Bean for his support in allowing for open public testimony on this issue in a special hearing.
Many of the above initiatives were carefully reviewed by FPA leadership and placed on the action list based upon the available resources of the FPA and the available legislative support that we can get from members of the House and Senate as well as how active our grassroots members get engaged on the issues. The leadership welcomes any opportunity to aggressively go after all pharmacy issues that need changes in policy however the reality of our limited resources and the amount of support of pharmacy stakeholders in the Florida Pharmacist Political Committee fundraising efforts define the reach of our advocacy program. Below is a report of the results of the 2016 session.
Important Bills that Passed
SB1604 (Revisions to the Florida Drug and Cosmetic Act) – One the issues advocated for by the FPA in SB1604 was a proposal to change the threshold where wholesalers must review orders for controlled substances. Current laws require wholesalers to assess orders greater than 5,000 unit doses of any one controlled substance. That threshold has now been raised to 7,500 unit doses. This threshold is not written in law that may cause a wholesaler to halt shipments to pharmacies rather it is a guide on when a distributor should determine whether the purchase by the pharmacy is reasonable. The FPA believes that this “number” may be contributing to pharmacies being denied shipments.
With new federal track and trace laws in place a number of changes were necessary to bring Florida laws in compliance with federal laws. This legislation replaced provisions related to pedigree with federal requirements for a transaction history (TH), transaction information (TI) or transaction statement (TS) for certain record keeping necessary for the manufacture and distribution of prescription drugs. In Florida under F.S. 499 drugs that do not have a TH, TI or TS could be designated as a “contraband prescription drug”. This language is replacing the references to Florida pedigree which means that pharmacies must be able to produce TH, TI or TS records to Department inspectors upon request. These records should be kept for 6 years.
Included in this bill were a number of new exclusions from the definition of wholesale distribution which include but are not limited to:
- Intracompany distribution between members of an affiliate or within a manufacturer;
- Distribution of a prescription drug by the manufacturer of that prescription drug
- The purchase or other acquisition by a dispenser, hospital, or other health care entity for use by that dispenser, hospital, or other health care entity
- Distribution of a prescription drug for the purpose of repacking the drug owned by a hospital for the hospital’s use or other health care entity that is under common control with the hospital
- Distribution of minimal quantities of prescription drugs by a retail pharmacy to a licensed practitioner for office use in compliance with the Florida Pharmacy Act and its rules (minimal quantities to be defined by DBPR rules)
- Distribution of an intravenous prescription drug that is intended for replenishment of fluids and electrolytes, or to maintain the equilibrium of water and minerals in the body
- Distribution of a prescription drug that is intended for irrigation or sterile water
- Distribution of exempt medical convenience kits
- Saleable returns when conducted by a dispenser
|Representative Matt Hudson meet with FPA’s
Tim Rogers and Scott Tomerlin
There was a clarification inserted into SB1604 that changed the definition of distribution of prescription drugs for emergency medical reasons. In the current law a retail pharmacy can transfer a prescription drug to another retail pharmacy to alleviate a temporary shortage for emergency medical reasons (EMR). Added to the definition is clarifying language that states that a drug shortage that is not caused by a public health emergency is not an EMR.
Nonresident prescription drug repackagers must now get a permit from the Florida Department of Business and Professional Regulations, Division of Drugs, Devices and Cosmetics.
SB1604 also clarifies that pharmacies within free standing end-stage renal dialysis clinics are not required to have a restricted prescription drug distributor permit if drug distributions are made to meet the immediate medical needs of specifically identified patients and are not occurring at a frequency where these transfers could be considered “systematic” supplying of a drug between pharmacies. The Department will be writing rules on this law change.
Prescription drug distributors that repackage and distribute prescription drugs to not-for-profit rural
|Pharmacists and Students Visit with
Rep Clovis Watson
hospitals are not required to comply with state and federal good manufacturing practices or state and federal rules on labels. These drug distributors will be required to comply with Department rules designed to ensure the safety and integrity of prescription drugs distributed and repackaged.
SB1604 allows DBPR to issue a retail pharmacy wholesaler permit to the same address of a community pharmacy or nuclear pharmacy that has a special sterile compounding permit so long as those nuclear pharmacies are manufacturing prescription drugs for use in PET or other radiopharmaceuticals and also the community pharmacy is not defined as a “closed” pharmacy.
This bill also creates F.S. 893.30 that requires the Florida Department of Health to develop a written pamphlet relating to controlled substances and the precautions regarding the use of pain management medications. The pamphlet should also include the following:
- The potential for misuse and abuse of controlled substances by adults and children
- The risk of controlled substance dependency and addiction
- The proper storage and disposal of controlled substances
- Controlled substance addiction support and treatment resources
- Telephone help lines and website links that provide counseling and emergency assistance for individuals dealing with substance abuse
Included in this section of 893.04 is a requirement for the Department to encourage health care providers to disseminate and display information about controlled substance safety and to encourage consumers to discuss the risks of controlled substance use with their health care providers. The Surgeon General must make the pamphlet publicly available on the Department’s web site and must fund the project with grants from private or federal sources.
HB1241 (Dispensing of Opioid Antagonists by Pharmacists) – During the 2015 legislative session new language was added to Florida laws that allowed for the dispensing of patient specific prescriptions of narcotic antagonist drugs to patients or the patient’s caregiver. This legislation revised Florida Statutes 381.887 allowing for pharmacists to dispense emergency opioid antagonistic drugs not only based upon a patient specific prescription but also allows a pharmacist to dispense opioid antagonists that are administered via autoinjection delivery system or intranasal application via a non patient-specific standing order. This dispensing must be appropriately labeled.
Included in this legislation is language that clarifies that a physician assistant under the delegated authority of a supervisory physician to order medications (including controlled substances) in licensed facilities such as hospitals and nursing homes. The bill also clarifies that an advanced registered nurse practitioner may also order medications (including controlled substances) in licensed facilities such as hospitals and nursing homes.
HB941 (General Health Department Revisions) – This bill is the Department of Health legislation that includes a number of issues of interest for pharmacy.
One of the policy statements adopted by the FPA House of Delegates was to give pharmacists the ability to provide a 30 day supply of maintenance medications when there are no refills remaining and the prescriber cannot be contacted. Pharmacists are granted this authority when the Governor declares a state of emergency. The FPA went to work on this proposal and had several opportunities to make this change though there was much resistance in the Florida House of Delegates. We were able to change 465.0275 and 893.04 regarding the pharmacy statutes on emergency refills which allows for a pharmacist to provide a one-time emergency refill of one vial of insulin to treat diabetes mellitus. This will permit pharmacists to provide more than a 72 hour resupply as permitted by current Florida law. There is interest in the legislature to revisit this issue next year.
The Office of Minority Health now includes in its title Health Equity. Included in this change is the addition of a Senior Health Equity Officer who will be responsible for administering grant programs that maximize the impact of funding to achieve health equity in Florida.
Revisions were made to Florida’ laws on sexually transmitted diseases (F.S. 384). A Florida statute 384.27 was revised that facilitates what is known as expedited partner therapy. The ability to provide expedited partner therapy under this statute may occur if the following are met:
- The patient has a laboratory-confirmed or suspected clinical diagnosis of a sexually transmissible disease
- The patient indicates that he or she has a partner with whom he or she engaged in sexual activity before the diagnosis of the sexually transmissible disease and
- The patient indicates that his or her partner is unable or unlikely to seek clinical services in a timely manner
This change in Florida laws allows a pharmacist to dispense medication to a person diagnosed with a STD for the purpose of treating that person’s partner regardless of whether the person’s partner has been personally examined by the prescribing health care practitioner. Pharmacists providing these dispensing services must check for potential allergic reactions before the prescription is dispensed. It is unknown if the Department of Health will adopt rules to implement this new law change.
EDITOR’S NOTE: It is unknown at press time how rulemaking is to move forward on this issue as this is not a change to Florida statutes 465 that governs the practice of pharmacy or whether the Board of Pharmacy has rulemaking authority. It is also believed that in order to comply with the section on allergic reactions that the pharmacist may need to create a record of the patient’s partner to be in compliance with the law.
Included in SB941 is language that provides alternative eligibility criteria for military members, and their spouses, seeking licensure as a health care practitioner in this state. The bill allows military health care practitioners who are practicing under a military platform, which is a training agreement with a nonmilitary health care provider, to be issued a temporary certificate to practice in this state.
Sections in SB941 prohibit the Department of Health from renewing any health care provider’s license who has not met continuing education requirements which is verified through the state’s CE tracking system. Created under the general health professions laws was F.S. 456.0361 that authenticate the Department of Health’s current practices utilizing CEBroker.
The bill removes a provision that allows candidates or applicants who had certain disqualifying offenses in their record and were enrolled in Board approved educational or training programs from becoming licensed in Florida.
A new exception to the pharmacy practice act was added to Florida statute 465.027. This exception allowed for manufacturers with a Florida permit under F.S. 499 to provide dialysate, drugs or devices necessary to perform home renal dialysis on patients with chronic kidney failure provided that the drugs are approved by the FDA, delivered in the original sealed packaging pursuant to the receipt of a physician’s order. The drug can be dispensed to either the patient or the patient’s designee for self administration. The drug can also be dispensed to the health care practitioner or to an institution for administration or delivery of the dialysis therapy.
Current law under 465.0276 requires the Department of Health to inspect dispensing practitioner facilities at the same frequency as pharmacies are to be inspected. House bill 941 removed that requirement which means that dispensing practitioner facilities will be randomly inspected. The Departments justification for this change is the need to concentrate resources where most of the activity is located. Since the ability to dispense certain controlled substances had been removed from dispensing practitioners the Department has determined that the volume of dispensing is lower.
Included in this bill is also a minor change on the initial licensure requirements for health care practitioners. Florida statutes 456.013 was changed in HB941 that removed a requirement for licensure candidates to have to complete the 2 hour medical errors CE before being issued their initial license. The requirement to take the 2 hour medical errors CE will remain for purposes of licensure renewal.
SB964 (Prescription Drug Monitoring Program) – SB964 made changes to Florida Statutes 893.055 by removing the requirements for rehabilitative hospitals, assisted living facilities nursing homes dispensing controlled substances from having to report to the prescription drug monitoring program. This bill also grants the authority for pharmacy technicians or the designee of a prescriber to query the PDMP database. The bill also grants the Department of Health impaired practitioner consultant access to the database for reviewing information on an impaired practitioner.
SB422 (Health Insurance Coverage for Opioid Drugs) – This bill passed by the House and Senate is allowing prior authorization programs for opioid drugs abuse deterrent properties so long as these prior authorization programs impose the same conditions for those drugs with without abuse deterrent properties.
HB691 (Retail Sale of Dextromethorphan) – This legislation prohibits a manufacturer, distributor or retailer from selling a finished product containing dextromethorphan to persons younger than 18 years of age. Proof of age must be presented unless the outward appearance of the purchaser is presumed to be 25 years of age or older. A violation could be a civil penalty of not more than $100. Individuals who possess or receive dextromethorphan products with intent to distribute to a person younger than 18 could receive up to a $100 fine. This language does not require special placement of dextromethorphan products behind the pharmacy counter. Local municipalities cannot write ordinances on the sale, distribution, receipt or possession of dextromethorphan.
HB423 (Prescribing of Controlled Substances by ARNPs and PAs) – For a number of years advanced registered nurse practitioners and physician assistants had been seeking prescribing authority for controlled substances. HB423 opens the doorway for that authority in Florida. This bill also makes changes to the state employee prescription benefit plan by authorizing payment for brand name drugs when prescribed as medically necessary by ARNPs and PAs. The bill also requires ARNPs and PAs to comply with the same controlled substance prescribing standards similar to what physicians must do under Florida statutes 456.44. The bill appears to limit the prescribing and dispensing of controlled substances in pain clinics only to medical doctors and doctors of osteopathic medicine.
Physician assistants would be required to take special CE on the safe and effective prescribing of controlled substances. The CE has to be provided by the Florida Medical Association. Physician assistants that prescribe schedule II controlled substances are limited to a 7 day supply and are restricted from prescribing psychiatric mental health controlled substances for children younger than 18.
This bill creates a special formulary committee that will be housed within the Board of Nursing to recommend a formulary of controlled substances that an advanced registered nurse practitioner “CANNOT” prescribe. A Florida licensed pharmacist with a PharmD will have a seat on this committee. This formulary must restrict the prescribing of psychiatric mental health controlled substances for children younger than 18 years of age and must also limit the prescribing of schedule II controlled substances to a 7 day supply. The exception to this would be psychiatric controlled substances that are prescribed by psychiatric nurses that are defined in F.S. 394.455. These prescribing restrictions do not apply to orders that are dispensed for purposes of administration to patients. ARNPs like physician assistants must complete continuing education provided by the Florida Medical Association.
Standardization of Prior Authorization – Included in HB423 is a provision that requires the insurance plans or their PBM that are not using an electronic prior authorization form on or after January 1, 2017 to use only a form approved by a collaboration of Florida’s Financial Services Commission and the Agency for Health Care Administration. This is designed to create a standardization of prior authorization programs through the PBMs.
HB242 Infectious Disease Elimination Pilot Program – This bill creates the Miami-Dade infectious Disease Elimination Act (IDEA) under Florida statutes 381.0038. Created within this new law is a sterile needle and syringe exchange pilot program through the University of Miami and its affiliates. The intent of the program is to try to prevent the spread of HIV, AIDS, viral hepatitis or other blood-borne diseases among IV drug users, their sexual partners and offspring. The program includes the one to one exchange of used needles and syringes for sterile ones. Educational materials must be provided. Quarterly reports must be reported to the Department of Health in Miami-Dade County by the 15th of October, January, April and July of each year with an annual report due each August 1st. A final report will be due on August 1, 2021. The program must be funded with grants.
HB1175 (Health Care Transparency) – In this bill licensed facilities such as hospitals and clinics will be required to provide financial information and quality of service measures to both current and potential patients. The financial information which must be made available on the facilities web site must include information on bundled payments for services and procedures. This information should include payments that the facility received except for those from Medicaid and Medicare. In general this bill is seeking to make public disclosure of the various relationships that a licensed hospital or clinic may have with health care practitioners and medical practice groups that the facility contracts with. The bill also is attempting to help consumers understand what services that they are being charged for. There are also provisions in the bill to create more transparency of health plan coverage however that transparency does not extend to any disclosures to providers such as MAC pricing methodology or reimbursement.
HB7087 (Telehealth) – This bill approved by the House and Senate creates a process to evaluate the feasibility of telehealth services in Florida. A telehealth advisory council has been created within the Agency for Health Care Administration to survey, research and make recommendations on telehealth services. The bill requires all health care providers defined under Florida statutes 456.001 (which includes pharmacists) to be surveyed on this issue as a condition of relicensure. A report of the results of this survey has to be submitted by October 31, 2017. There is also a provision that gives the Department of Health the authority to assess a fine against a health care facility, health maintenance organization, health care practitioner, and health insurer for failure to complete the surveys on telehealth.
HB1347 (Revisions to the Controlled Substance Act) – This bill seeks to create a new way of regulating emerging formulas of controlled substances in Florida. Instead of specifically naming the chemical formula of drugs that are abused, this change in law created an “analog statute” which means that a substance could be categorized as a controlled substance in schedule I if it is substantially similar to one currently listed in schedule I or schedule II, has a hallucinogenic, stimulant or depressant effect on the central nervous system similar or greater than that listed in schedule I or schedule II.
HB307 Medical Use of Cannabis – This legislation allows dispensing organizations to cultivate, transport and dispense medical cannabis in addition to the low THC cannabis approved by the legislature a few years ago. This legislation also creates additional regulatory standards under Florida’s Compassionate Medical Cannabis Act that passed in 2014 for the 5 dispensing organizations approved by the Department of Health. There are also strengthened criteria for the physicians who wish to become the medical directors of dispensing organizations. There is also increased accountability for those who have access to Low-THC or medical cannabis and additional security of premises and personnel. Some 47 amendments were tossed at this bill with most either rejected or withdrawn. This legislation which has been signed into law by Governor Scott does not have a role for pharmacists or pharmacies.
Other Bills of Interest that Did Not Pass
SB780/HB583 (Exclusive Pharmacy Services) – These two FPA supported bills were filed to address patient access to prescription drugs restricted by their health plans. The Senate version was designed to create a level playing field between mail order and community pharmacy by making the copays the same and prohibiting HMOs or group health plans from requiring patients to get their medications exclusively by mail. Pharmacies would have to agree to the contract terms that the mail order pharmacy would receive. The House version had a slightly different approach in that the original version of this legislation allowed patients who are being treated for diabetes, hypertension HIV and epilepsy to get their maintenance medications from mail order or from community pharmacies that agree to the terms and conditions of the contract. While the Senate version of this bill moved along house version was greatly restricted to only apply to HIV patients. Both bills eventually died in committee.
HB547/SB692 (Access to Pharmacist Services Act) – This bill filed as a priority by FSHP and supported by the FPA would have revised the definition of the practice of the profession of pharmacy to allow a pharmacist to:
- Consult on the therapeutic values and interactions of patent or proprietary products and health and wellness assessments and patient care relating to medication therapy management;
- Manage, in addition to monitor and review, a patient’s drug therapy;
- Collaborate with a patient’s health care provider, the provider’s authorized agent, or other persons specifically authorized by the patient regarding the patient’s health care status, in addition to the patient’s drug therapy; and
- Dispense medications, including vaccines, in addition to the administration of such medications.
This bill would have expanded the abilities that consultant pharmacists and doctors of pharmacy have by allowing them to perform medication management, patient health and wellness assessments, counseling and referrals relating to medications and health care services in accordance with the current laws and standards. Under this bill consultant pharmacists and doctors of pharmacy would:
- Have the ability to order and evaluate diagnostic, laboratory, or clinical testing without authorization by a physician.
- Initiate, modify, discontinue, and administer drugs within the context of a drug therapy management protocol or order in collaboration with one or more health care providers.
The bill also would have allowed for the reimbursement for patient care services apart from medication prescriptions by health benefit plans or insurers. The House version was introduced in its first committee but was eventually withdrawn due to concerns from the medical associations. The Senate version was withdrawn without a hearing.
SB1378/HB1329 (Drug Safety) – This legislation entitled “Victoria’s Law would have required pharmacies to offer for sale prescription lock boxes. These bills also included a requirement for the Department of Health to create and distribute a consumer pamphlet on controlled substances. In these bills the pharmacists would have been required to issue these pamphlets to patients for each prescription filled or refilled. This bill passed the Senate but died in House messages. The House version never was heard in committee. The pamphlet however still must be created by the Department of Health (see SB1604) however pharmacists would not be required to provide them with each prescription dispensed.
SB7038 (Review of Orders for Controlled Substances) – This bill included one of the provisions advocated for by the FPA. In Florida statutes 499.0121 prescription drug wholesalers are required to evaluate orders for more than 5,000 unit doses of any one controlled substance to determine of the order is suspicious. The FPA felt that this is one of the causes of pharmacy orders being denied or perhaps a reason why pharmacies were unable to maintain enough supply for help their customers. The language in 7038 removed the 5,000 dosage language however the bill ultimately passed in SB964 raising the 5,000 dosage units to 7,500 dosage units before a wholesaler would be required to conduct a review.
SB1142/HB915 (Treatments for Stable Patients) – These bills would have prohibited any pharmacy benefit manager (PBM) and any individual or group health insurance policy or HMO contract providing major medical coverage from limiting or excluding coverage for a drug for an insured with a complex or chronic medical condition or a rare disease if:
- The drug was previously approved for coverage by the insurer for a medical condition or disease of the insured,
- The prescribing provider continues to prescribe the drug for the medical condition or disease, and
- The drug is appropriately prescribed and considered safe and effective for treatment of the insured’s medical condition or rare disease.
In addition, for any drug prescribed to an insured with a complex or chronic medical condition or a rare disease, the bill would have prohibited a health insurer, HMO or PBM from engaging any of the following actions, except during open enrollment periods:
- Placing limitations on the maximum coverage of prescription drug benefits,
- Increasing the out-of-pocket costs paid by the insured for the drug, and
- Moving the drug to a disadvantaged tier.
The Senate version sponsored by Senator Hayes passed two of its three committee references with no objection however the House version was never heard.
SB1472/HB1161 (Requirement for Information on a Prescription Label) – These bills would have amended F.S. 456.42 and would have required prescribing practitioners who issue prescriptions for controlled substances to include the medical condition on the prescription if requested by the patient. The pharmacist or dispensing practitioner would be required to include this medical condition on the prescription label. The prescribing practitioner would have to get a waiver from the patient. The Senate version passed one committee. The House version was never heard in committee.
HB1093 (Prescription Drug Coverage) – This bill sponsored by Representative Larry Lee was designed to stop health insurance plans from excluding pharmacies from participating if those pharmacies were willing to agree to the terms and conditions of a contract. There was no Senate version of this bill and it died without a hearing.
We are again pleased to report that even with a very active legislative agenda and the approaching election season we were successful in getting several pharmacy friendly initiatives through the House and Senate and on to the Governor’s desk for his signature. This is not by any means an easy task and it is through the tenacious efforts of your leadership that we were able to say that we made good things happen and successfully defended against the bad stuff. We have a great advocacy team at Adams Street Advocates and the Lockwood Law Firm. Together with our communications engine the FPA is working hard on your behalf to keep you informed and aware of what is changing around us.
There is still much work to be done and a great opportunity to get on board with a host of new legislative campaigns under way. As a member you have a stake on where this profession is going which means that you are either at the table or you are on the menu. Don’t let someone else chow down on your future. A final version of this report will be available during the 126th FPA Annual Meeting and Convention in Ft. Lauderdale. June 30 – July 3, 2016. Mark your calendars.