2015 Legislative Session Report
FPA Advocacy Efforts for 2014-2015
For the second year in a row the FPA working with our advocacy team of Adams Street Advocates have been successful in proactively advancing nearly all of our Association approved policy issues at the Florida Capitol. This is truly remarkable when the ability to make changes to the practice act or revise other health related laws that define what pharmacists can or cannot do is nearly impossible. Revising Florida laws is an extensive, time consuming process and utilizes vast amounts of financial resources and a dedicated volunteer network. It is not a process for the weak or the meek. This year’s legislative session was rather unique in that the House of Representatives unexpectedly adjourned 3 days prior to the end of the session due to an impasse with the Florida Senate over the state’s budget. This will mean that the House and Senate had to come back to Tallahassee in a special session to debate Florida’s 2015-2016 funding plan. This action by the House resulted in a number of legislative bills unresolved. Our FPA advocates worked quickly to get our issues out of the House and Senate and avoided the blowup between the two chambers.
Planning for legislative campaigns began as soon as the previous legislative session ended. In July of 2014 after the annual meeting in Ft. Lauderdale the FPA’s Governmental Affairs Committee met in Orlando to begin crafting our advocacy plan. The FPA does not have an unlimited checking account balance and our resources in our political committee have limits. As such we have to evaluate and prioritize the needs of the profession and match them our available war assets. For the past two years our PAC Board of Directors had been strategically authorizing political campaign support their efforts is beginning to bear fruit on the vine.
The Governmental Affairs Committee appointed by President Suzanne Kelley and chaired by FPA member Preston Mcdonald crafted the 2015 advocacy plan which consisted of the following:
Advocate for standalone legislation
- Expansion of current immunizations administered by pharmacists to the CDC recommendations.
- Advocate for relief of MAC pricing issues.
- Advocate for MTM payments in the Medicaid program
Advocate for if opportunity presented
- Monitor for opportunities for allowing interns to provide immunizations under the supervision of a registered immunizing pharmacist
- Advocate for patient access to their pharmacy of choice
Monitor and Educate Legislators
- Permanent funding of the prescription drug monitoring program. It was recommended that we continue to educate members of the House and Senate on PDMP and the need for a sustainable funding source.
- Monitor proposed legislation on medical marijuana.
This proposed plan was presented to the FPA Board of Directors that includes the elected officers of the FPA, 9 regional directors from across the state and the president of the Florida Society of Health-System Pharmacists. The Board adopted the proposed advocacy plan with the addition of working to support the national initiatives on provider status. Below is a summary of the pharmacy issues the FPA has advocated for your behalf.
ISSUES PASSED THE FLORIDA HOUSE AND SENATE
Expansion of immunization Authority (HB279) – Currently Florida laws allows pharmacists to administer 4 vaccines (influenza, pneumococcal, meningococcal and shingles vaccines). House bill 279 sponsored by Representative Pigman and its Senate companion sponsored by Senator Aaron Bean was found favorable by the Florida Legislature. The bill is currently headed to the Governor’s office for his signature. House bill 279 which was signed into law by Scott:
- Revise the list of vaccines that a pharmacist could administer by adding all immunizations or vaccines recommended by the Center for Disease Control (CDC) for adults published as of February 1, 2015.
- Allow registered interns under the supervision of a certified immunizing pharmacist to administer immunizations or vaccines recommended by the CDC to adults
- Permit pharmacists and interns to administer immunizations or vaccines recommended by the CDC for international travel starting July 1, 2015. The Board of Pharmacy has been given rulemaking authority to revise the list of international travel vaccines when recommended by the CDC.
- Allow for additional immunizations or vaccines approved by the Board of Pharmacy in response to a state of emergency declared by the Governor as described in Florida Statutes 252.36.
- Limit the number of interns administering immunizations or vaccines that a pharmacist could supervise to one.
- Requires registered pharmacy interns to complete the 20 hour initial certification training program approved by the Board of Pharmacy prior to immunizing patients.
EDITOR’S NOTE: One of the vaccines that is on the CDC’s list for travel vaccines is for the prevention of yellow fever. Yellow fever is caused by infection with yellow fever virus (YFV), a flavivirus in the same family as west nile virus and dengue virus. Yellow fever was previously a major public health concern in the United States and was responsible for several large outbreaks in Florida during the 1700's and 1800's. Yellow fever currently occurs only in tropical regions of Africa and parts of South America. The last epidemic in North America occurred in New Orleans in 1905. Members may need to be aware that if considering the administration of travel related vaccines that you may have to received a designation from the Florida Department of Health. There is a questionnaire for yellow fever immunizing practitioners available from the Department of Health Disease Control Bureau of Epidemiology.
Maximum Allowable Cost Standards (MAC) HB1049 – New language was added Florida Statutes 465.1862 to the pharmacy practice act the defined what a PBM is and created MAC pricing standards. House bill 1049 signed into law by Governor Scott will created F.S. 465.1862 and:
- Defines “maximum allowable cost” (MAC) as the per unit amount that a pharmacy benefits manager reimburses a pharmacist for a prescription drug, excluding dispensing fees and prior to the application of copayments, coinsurance and other cost-sharing charges if any
- Defines a pharmacy benefits manager (PBM) as a person or entity doing business in Florida which contracts to administer or manage prescription drug benefits on behalf of a health insurance plan defined in Florida statutes to residents of this state.
- Requires that each PBM contract or contract renewal between the PBM and the pharmacy have certain requirements which include the following:
o MAC pricing must be updated every 7 days
o Have in place a process to timely eliminate drugs from the MAC list or modify drug prices to remain consistent with pricing data which is used in formulating MAC pricing and product availability.
EDITOR’S NOTE: The bill was originally filed to address some concerns within the veterinary health profession over an adopted pharmacy rule related to compounding. Florida statutes 465.026 was revised in this bill to clarify that the pharmacy practice act and its rules would not prohibit a veterinarian from administering a compounded drug to an animal or dispensing a compounded drug to the animal’s owner or caretaker.
Pharmacist Provider Status (HB655) – This legislation is the first step in a number of initiatives needed to clarify pharmacist provider status. There are currently sections of existing Florida laws that allow Pharm.D and consultant pharmacists to order and evaluate laboratory tests in certain settings. While this authority is granted in F. S. 465.0125 the statutes where clinical laboratories are regulated under only list physicians, chiropractors, podiatrists, naturopaths, optometrists, dentists or ARNPs as practitioners that send specimens for testing. HB655 signed into law by Governor Scott added pharmacists licensed under 465 to that list of practitioners. The clinical laboratories will not be able to charge different prices for services based upon whether or not the ordering practitioner is a pharmacist.
Emergency Treatment for Opioid Overdose (HB751) – This legislation approved by the House and Senate is entitled the “Emergency Treatment and Recovery Act” (ETRA). There has been significant amount of attention given to opioid overdoses recently. The issue that this legislation is trying to fix is access to opioid antagonists when there is a need for emergency treatment. HB751 which was signed into law by Governor Scott:
- Increases access to opioid antagonists to patients and caregivers
- Encourages the prescribing of emergency opioid antagonists by authorized health care practitioners
- Allows pharmacists to dispense emergency opioid antagonist from prescriptions written in the name of the patient or the caregiver of the patient
- Allows patients or caregivers to store and possess approved emergency opioid antagonists
- Allows for the administration of an opioid antagonist to a person believed (in good faith) to be experiencing an opioid overdose when a physician is not immediately available
- Grants authority for emergency responders such as law enforcement officers, paramedics and EMTs to possess, store and administer opioid antagonists when clinically indicated
- Grants civil liability immunity to prescribing practitioners, dispensing practitioners and pharmacists who are acting under the “Emergency Treatment and Recovery Act”
- Limits the ability to for the Department to discipline an authorized health care practitioner acting under the “Emergency Treatment and Recovery Act” provided that they do so exercising reasonable care and acting in good faith.
- Creates immunity from criminal liability from prescribing or dispensing an emergency opioid antagonist under the ETRA.
- Would not limit existing immunities for emergency responders or practitioners
- Would not create a duty or standard of care for a person who prescribes or administers an emergency opioid antagonist
Diabetes Advisory Council (SB296) – For quite some time there has been a group in Florida called the Diabetes Advisory Council. The purpose of the Council is to guide a statewide comprehensive approach to diabetes prevention, diagnosis, education, care, treatment, impact, and costs. The Diabetes Advisory Council serves as the advisory unit to the Department of Health, other governmental agencies, professional and other organizations, and the general public. There are currently 26 members of which 5 are interest citizens. Three of these citizens are affected by diabetes. The 21 other members include representatives from the various health professions including pharmacy, are appointed by the governor and serve 4 year terms. In 2013 diabetes was the 6th leading cause of death in Florida. Senate bill 296 signed into law by Governor Scott:
- Directs the Diabetes Advisory Council to work with the Department of Health, the Agency for Health Care Administration and the Department of Management Services to prepare and submit a report by January 10th in each odd numbered year to the Governor, Senate President and Speaker of the House the impact that diabetes has on state funded or operated programs such as Medicaid and the state employee benefit plan
- Requires the report to include a description and assessment of the effectiveness of diabetes programs and activities that have been implemented by the various state agencies
- Requires that the above report should include the source and funding of the programs and activities and the cost savings realized.
- Directs the Council to submit a description of the coordination among the various state agencies of their respective programs, activities and communications that are designed to manage, treat and prevent all types of diabetes.
- Directs the Council to develop and or propose revisions to a detailed action plan for reducing and controlling the number of new diabetes cases. The plan should include action steps to reduce the impact of all types of diabetes, identification of expected outcomes if the plan is implemented and the establishment of benchmarks for prevention and control.
- Retains the opportunity for pharmacist representation on the Council
Pharmacists Training of TLF Staff (SB682) – Transitional living Facilities provide specialized health care services, including, but not limited to rehabilitative services, community reentry training, aids for independent living, and counseling to persons with spinal cord or head injuries. There are currently 14 facilities located in Florida. New Florida laws (400.997 through 400.9985) have been created for the regulation of these facilities. These facilities originally existed under other sections of Florida laws. Included in SB682 was language requiring training of unlicensed direct care services staff who administer prescribed, prepackaged and premeasured medications. In this bill the training can be performed by a Florida licensed registered nurse, physician or pharmacist.
Revision of the Florida Controlled Substance Act (HB897) – The Florida controlled substance act (F.S. 893 has listed in Schedule I about 175 chemical substances that have a high potential for abuse and have no currently accepted medical use in the United States. Each year this list is revised in an effort to recognize new formulas of synthetic cannabinoids that are being produced in the illicit market. Synthetic cannabinoids (also known as “K2” or “Spice”) are chemically engineered substances that have a similar structure to tetrahydrocannabinol (THC) and produce a high similar to marijuana when ingested. HB897 has been signed into law by the Governor and adds the following chemicals to F.S. 893.03 (1) (c):
- AB-CHMINACA: N-[1-(aminocarbonyl)-2-methylpropyl]-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide;
- FUB-PB-22: Quinolin-8-yl-1-(4-fluorobenzyl)-1H-indole-3-carboxylate;
- Fluoro-NNEI: 1-(Fluoropentyl)-N-(naphthalen-1-yl)-1H-indole-3-carboxamide;
- Fluoro-AMB: Methyl 2-(1-(fluoropentyl)-1H-indazole- 3-carboxamido)-3-methylbutanoate; and
- THJ-2201: [1-(5-Fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone.
Self Administration of Insulin in ALFs * Training of Medication Administration Staff (HB1001) – There are two items of interest in this legislation that passed the House and Senate and was signed into law by Governor Scott.
- In assisted living facilities patients can receive assistance with the administration of their medications. New language was added to Florida Statutes 429.256 that clarifies that insulin syringes that are prefilled with the proper dosage by a pharmacist and an insulin pen that is prefilled by the manufacturer can be brought to a patient residing in an ALF.
- Currently staff of ALFs that are involved in the management of medications and assisting with the self-administration of mediations in an ALF must complete a minimum of 4 hours of training that can be provided by a registered nurse, licensed pharmacists or department staff. That training requirement now has been increased to 6 hours.
Experimental Treatments for Terminal Conditions (HB269) – This bill creates within Florida Statutes 499.0295 the “Right to Try Act” and allows for the use of investigational drugs to be provided by prescription drug manufacturers and administered to patients with a terminal condition and where there is documentation of informed consent. HB269 protects the licenses of physicians from discipline who recommend the use of investigational drugs. This legislation allows for payment by insurance plans but does not require that payment. There is also liability protection for manufacturers and other persons involved in the patient’s care. If a patient dies while using an investigational drug, biological product or device described in F.S. 499.0295 the patient’s heirs are not liable for any outstanding debt from the use of these drugs or devices.
Freedom for Patients to Choose Their Pharmacy – While not a subject on the table for the 2015 legislative session this issue is worthy of a reminder that state employees now have the option to have their 90 day maintenance medications dispensed at their community pharmacy rather than mandatory mail. FPA advocates and staff met repeatedly with the Department of Management Services on this issue. Pharmacies that wish to participate in the 90 day maintenance at retail program can contact Caremark Retail Services at 1-866-488-4708. Additional information was published in the September 25, 2014 issue of Stat News.
National Provider Status Initiative – On a national level the FPA is working with a host of pharmacy organizations to advocate for pharmacist provider status recognition. S314 has been filed in the Senate during the 114th Congress. This bill has 28 Senate cosponsors however neither of our state Senators has signed onto this bill yet. The House version HR592 has 185 cosponsors with 10 of them from Florida as this article is being published. These bills if passed by Congress and signed into law by President Barack Obama would recognize pharmacists in the Social Security act as health care providers in underserved areas. This is an ongoing advocacy program with a tremendous amount of outreach and collaboration with our national partners.
ISSUES OF INTEREST THAT DID NOT PASS
2015-2016 Budget Plan – The only thing that the Florida legislature is obligated to do during the session is to review and pass an annual budget. Unlike Congress the State of Florida must pass a budget that is balanced. Very late during the session it became clear that the House and Senate were very far apart on their funding plan. The Senate’s proposal suggested the use of Federal money to cover the cost of the indigent care in this state while the House as locked in on rejecting the use of those funds for fear that Washington may eventually back off of their offer. This legislative session ended without an approved budget. The legislature had to come back into special session to finally prepare and pass the state of Florida spending plan for 2015-2016.
Advance Registered Nurse Practitioners and Physician Assistant Prescribing – There were numerous bills filed during the 2015 legislative session designed to give controlled substance prescribing authority to advanced registered nurse practitioners and physician assistants. One proposed bill (HB547) sought to give ARNPs independent practice authority from physicians and change their designation to “Independent Advance Practice Registered Nurse”. Preliminary analysis of the 2015 legislative session appears to reveal that none of these bills were able to get out of the House and Senate. While several of the bills made it through the Committee process with not a lot of objections, the House leaving early did not give an opportunity for the Senate and the House of Representatives to reconcile their bills which must match before they are sent to the Governor for signature.
Medical Use of Marijuana – Similar to last year a host of bills were filed this year to modify changes or create new laws allowing for the use of medical marijuana. Members may recall a ballot initiative last fall that nearly received enough votes to legalize marijuana. A bill passed during the 2014 legislative session to allow for the use of non-euphoric medical cannabis. The Department of Health has been working on rule making but has been hampered by rule challenges. As directed by the 2014 House of Delegates the FPA has been actively talking with the issue’s interested parties as policy making was being developed. No bills related to the use of marijuana appear to have passed the 2015 legislative session.
Telehealth – Two bills were filed during the 2015 session that would authorize Florida licensed health care professionals including pharmacists to use telehealth to deliver health care services that are within their scope of practice. The bill would have allowed the use of telehealth to prescribe for controlled substances with the exception of medications used to treat chronic nonmalignant pain. Neither the House nor Senate bill made it to the floor.
Summary – This year will be a memorable event in pharmacy advocacy in Florida. Look at the list of issues that crossed the finish line in this report and compare them to the advocacy work plan approved by FPA leadership. It is not often we have an opportunity to say that nearly everything we set out to do we accomplished. This was a phenomenal campaign that together we must continue working to keep the momentum. Our state’s pharmacy students were highly engaged and got involved like never before. Next year’s legislative session will begin on January 12th so we will begin preparing for that at convention.
| Adams Street Advocates Team