The Florida Senate BILL ANALYSIS AND FISCAL IMPACT STATEMENT (This document is based on the provisions contained in the legislation as of the latest date listed below.) Prepared By: The Professional Staff of the Committee on Health Policy BILL: SB 1320 INTRODUCER: Senator Calatayud SUBJECT: HIV Infection Prevention Drugs DATE: January 29, 2024 ANALYST STAFF DIRECTOR REFERENCE ACTION 1. Rossitto-Van Winkle Brown HP Pre-meeting 2. AHS 3. RC I. Summary: SB 1320 creates s. 465.1861, F.S., authorizing a pharmacist to order and dispense HIV drugs under a collaborative practice agreement (CPA) with a medical or osteopathic physician. The bill defines the following terms: HIV, HIV infection prevention drug, postexposure prophylaxis, and preexposure prophylaxis. The bill authorizes a pharmacist to screen an adult for HIV and provide the results to that adult without a CPA. If the results are positive, the pharmacist is required to advise the patient that he or she should seek further medical consultation or treatment from a physician. The bill authorizes a pharmacist to order or dispense HIV prevention or treatment drugs under a CPA and also requires the pharmacist to be certified by the Board of Pharmacy (BOP) before he or she may do so. Certification under the bill requires the pharmacist to meet specified criteria. The bill provides an effective date of July 1, 2024. REVISED: BILL: SB 1320 Page 2 II. Present Situation: Pharmacist Licensure Pharmacy is the third largest health profession behind nursing and medicine. 1 The BOP, in conjunction with the Department of Health (DOH), regulates the practice of pharmacists pursuant to ch. 465, F.S. 2 To be licensed as a pharmacist, a person must: 3 Complete an application and remit an examination fee; Be at least 18 years of age; Hold a degree from an accredited and approved school or college of pharmacy; 4 Have completed a BOP-approved internship; and Successfully complete the BOP-approved examination. A pharmacist must complete at least 30 hours of BOP-approved continuing education during each biennial renewal period. 5 Pharmacists who are certified to administer vaccines or epinephrine auto-injections must complete a three-hour continuing education course on the safe and effective administration of vaccines and epinephrine auto-injections as a part of the biennial licensure renewal. 6 Pharmacists who administer long-acting antipsychotic medications must complete an approved eight-hour continuing education course as a part of the continuing education. 7 Pharmacist Scope of Practice In Florida, the practice of the profession of pharmacy includes: 8 Compounding, dispensing, and consulting concerning the contents, therapeutic values, and uses of any medicinal drug; Consulting concerning therapeutic values and interactions of patent or proprietary preparations; Monitoring a patient’s drug therapy and assisting the patient in the management of his or her drug therapy, including the review of the patient’s drug therapy and communication with the patient’s prescribing health care provider or other persons specifically authorized by the patient; Transmitting information from prescribers to their patients; 1 American Association of Colleges of Pharmacy, About AACP, available at https://www.aacp.org/about-aacp (last visited Jan. 24, 2024). 2 Sections 465.004 and 465.005, F.S. 3 Section 465.007, F.S. The DOH may also issue a license by endorsement to a pharmacist who is licensed in another state upon meeting the applicable requirements set forth in law and rule. See s. 465.0075, F.S. 4 If the applicant has graduated from a 4-year undergraduate pharmacy program of a school or college of pharmacy located outside the U.S., the applicant must demonstrate proficiency in English, pass the board-approved Foreign Pharmacy Graduate Equivalency Examination, and complete a minimum of 500 hours in a supervised work activity program within Florida under the supervision of a DOH licensed pharmacist. 5 Section 465.009, F.S. 6 Section 465.009(6), F.S. 7 Section 465.1893, F.S. 8 Section 465.003(13), F.S. BILL: SB 1320 Page 3 Administering specified vaccines to adults and influenza vaccines to persons seven years of age or older; 9 Administering epinephrine autoinjections; 10 and Administering antipsychotic medications by injection. 11 A pharmacist may not alter a prescriber’s directions, diagnose or treat any disease, initiate any drug therapy, or practice medicine or osteopathic medicine, unless permitted by law. 12 Pharmacists may order and dispense drugs that are included in a formulary developed by a committee composed of members of the Board of Medicine, the Board of Osteopathic Medicine, and the BOP. 13 The formulary may only include: 14 Any medicinal drug of single or multiple active ingredients in any strengths when such active ingredients have been approved individually or in combination for over-the-counter sale by the U.S. Food and Drug Administration (FDA); Any medicinal drug recommended by the FDA Advisory Panel for transfer to over-the- counter status pending approval by the FDA; Any medicinal drug containing any antihistamine or decongestant as a single active ingredient or in combination; Any medicinal drug containing fluoride in any strength; Any medicinal drug containing lindane in any strength; Any over-the-counter proprietary drug under federal law that has been approved for reimbursement by the Florida Medicaid Program; and Any topical anti-infectives, excluding eye and ear topical anti-infectives. A pharmacist may order the following, within his or her professional judgment and subject to the following conditions: Certain oral analgesics for mild to moderate pain. The pharmacist may order these drugs for minor pain and menstrual cramps for patients with no history of peptic ulcer disease. The prescription is limited to a six-day supply for one treatment of: o Magnesium salicylate/phenyltoloxamine citrate; o Acetylsalicylic acid (zero order release, long acting tablets); o Choline salicylate and magnesium salicylate; o Naproxen sodium; o Naproxen; o Ibuprofen; o Phenazopyridine, for urinary pain; and o Antipyrine 5.4%, benzocaine 1.4%, glycerin, for ear pain if clinical signs or symptoms of tympanic membrane perforation are not present; Anti-nausea preparations; Certain antihistamines and decongestants; 9 See s. 465.189, F.S. 10 Id. 11 Section 465.1893, F.S. 12 Section 465.003(13), F.S. 13 Section 465.186, F.S. 14 Id. BILL: SB 1320 Page 4 Certain topical antifungal/antibacterials; Topical anti-inflammatory preparations containing hydrocortisone not exceeding 2.5%; Certain otic antifungal/antibacterial; Salicylic acid 16.7% and lactic acid 16.7% in flexible collodion, to be applied to warts, except for patients under 2 years of age, and those with diabetes or impaired circulation; Vitamins with fluoride, excluding vitamins with folic acid in excess of 0.9 mg.; Medicinal drug shampoos containing lindane for the treatment of head lice; Ophthalmic. Naphazoline 0.1% ophthalmic solution; Certain histamine H2 antagonists; Acne products; and Topical antiviral for herpes simplex infections of the lips. 15 Collaborative Pharmacy Practice Agreements Under s. 465.1865, F.S., a collaborative pharmacy practice agreement (CPPA) is a formal agreement in which a physician licensed under ch. 458 or 459, F.S., makes a diagnosis, supervises patient care, and refers patients to a pharmacist under a protocol that allows the pharmacist to provide specified patient care services for certain chronic medical conditions. A CPPA specifies what functions beyond the pharmacist’s typical scope of practice can be delegated to the pharmacist by the collaborating physician. 16 Common tasks include initiating, modifying, or discontinuing medication therapy and ordering and evaluating tests. 17 Pharmacist Training for Collaborative Practice To provide services under a CPPA, a pharmacist must be certified by the BOP. To obtain certification a pharmacist must complete a 20-hour course approved by the BOP, in consultation with the Board of Medicine (BOM) and the Board of Osteopathic Medicine (BOOM), and: Hold an active and unencumbered license to practice pharmacy; Have a Ph.D. in pharmacy or have five years of experience as a licensed pharmacist; Have completed the BOP-approved, 20-hour course, eight hours of which must be live or live video conference that includes instruction in: o Performance of patient assessments; o Ordering, performing, and interpreting clinical and laboratory tests; o Evaluating and managing diseases and health conditions in collaboration with other health care practitioners; and o Writing and entering into a CPPA. Maintains at least $250,000 of professional liability insurance coverage; and Has established a system to maintain patient records of patients receiving services under a CPPA for five years from the patient’s most recent service. 18 15 Fla. Admin. Code R. 64B16-27.220 (2023). 16 U.S. Center for Disease Control and Prevention, Advancing Team-Based Care Through Collaborative Practice Agreements: A Resource and Implementation Guide for Adding Pharmacists to the Care Team, (2017) available at https://www.cdc.gov/dhdsp/pubs/docs/CPA-Team-Based-Care.pdf (last visited Jan. 25, 2024). 17 Id. 18 Section 465.1865(2), F.S. and Fla. Admin. Code R. 64B-31.007 (2023). BILL: SB 1320 Page 5 Required Contents of CPPA The terms and conditions of the CPPA must be appropriate to the pharmacist’s training, and the services delegated to the pharmacist must be within the collaborating physician’s scope of practice. A copy of the certification received from the BOP must be included as an attachment to the CPPA. A CPPA must include the following: The name of the collaborating physician’s patient(s) for whom a pharmacist may provide services; Each chronic health condition to be collaboratively managed; The specific medicinal drug(s) to be managed for each patient; Material terms defined as those terms enumerated in s. 465.1865(3)(a), F.S.; Circumstances under which the pharmacist may order or perform and evaluate laboratory or clinical tests; Conditions and events in which the pharmacist must notify the collaborating physician and the manner and timeframe in which notification must occur; The start and ending dates of the CPPA and termination procedures, including procedures for patient notification and medical records transfers; A statement that the CPPA may be terminated, in writing, by either party at any time; and In the event of an addendum to the material terms of an existing CPPA, a copy of the addendum and the initial agreement. A CPPA will automatically terminate two years after execution if not renewed. The pharmacist, along with the collaborating physician, must maintain the CPPA on file at his or her practice location and must make the CPPA available to the DOH or BOP upon request or inspection. A pharmacist who enters into a CPPA must submit a copy of the signed agreement to the BOP before the agreement may be implemented. 19 Allowable Chronic Health Conditions for Pharmacist CPPAs CPPAs in Florida allow a pharmacist to provide specific patient care services for the following chronic health conditions: Anti-coagulation management; Arthritis; Asthma; Chronic obstructive pulmonary disease (COPD); Human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS); Hyperlipidemia; Hypertension; Nicotine dependence; Obesity; Opioid use disorder; Type 2 diabetes; Hepatitis C; and 19 Section 465.1865(3), F.S. and Fla. Admin. Code R. 64B-31.003 (2023). BILL: SB 1320 Page 6 Any other chronic condition adopted in rule by the BOP, in consultation with the Board of Medicine and the Board of Osteopathic Medicine. 20 Prohibited Acts Regarding a CPPA A pharmacist may not: Modify or discontinue medicinal drugs prescribed by a health care practitioner with whom he or she does not have a CPPA; or Enter into a CPPA while acting as a pharmacy employee without the written approval of the owner of the pharmacy. A physician may not delegate the authority to initiate or prescribe a controlled substance listed in s. 893.03, F.S. or 21 U.S.C. s. 812, to a pharmacist. Continuing Education A pharmacist who practices under a CPPA must complete an eight-hour continuing education (CE) course approved by the BOP that addresses CPPA-related issues each biennial licensure renewal, in addition to the CE requirements under s. 465.009, F.S. A pharmacist wishing to maintain CPPA certification must submit confirmation of having completed such course when applying for licensure renewal. A pharmacist who fails to complete this CE is prohibited from practicing under a CPPA. CPPAs in Effect According to the DOH 2022 - 2023 Annual Report there are 39,337 licensed pharmacists in Florida. 21 There are 120 pharmacists certified to provide care under a CPPA. There are 37 pharmacists and 37 physicians actively engaged in collaborative practice. The BOP has received 97 CPPAs, 47 of which contain more than one chronic health condition that can be collaboratively managed. 22 The chart below illustrates the composition of chronic conditions treated by CPPA as of March 31, 2023. 23 20 Section 465.1865, F.S. and Fla. Admin. Code R. 64B-31.005 (2023). The statute provides for arthritis, asthma, COPD, Type 2 diabetes, HIV/AIDS, and obesity. The other items in the list (anti-coagulation management, hyperlipidemia, hypertension, nicotine dependence, opioid use disorder, and hepatitis C) were added under BOP rule. 21 Florida Department of Health, Division of Medical Quality Assurance, Annual Report and Long-Range Plan, Fiscal Year 2022-2023, at pg. 4, available at https://www.floridahealth.gov/licensing-and-regulation/reports-and-publications/annual- reports.html (last visited Jan. 26, 2024). 22 Florida Department of Health, Division of Medical Quality Assurance, Pharmacy Collaborative Practice Agreements, Report to Senate Health Policy Committee, Aug, 1, 2023, (on file with the senate Committee on Health Policy). While the number of participating pharmacists and physicians are identical, this does not represent a one-to-one ratio; a pharmacist may have multiple agreements with more than one physician just as multiple physicians may have multiple agreements with more than one pharmacist. 23 Id. BILL: SB 1320 Page 7 Condition Count Anti-Coagulation Management 48 Arthritis 46 Asthma 46 COPD 46 HIV/AIDS 85 Hyperlipidemia 45 Hypertension 50 Nicotine Dependence 44 Obesity 48 Opioid Use Disorder 1 Type 2 Diabetes 48 Human Immunodeficiency Virus (HIV) The human immunodeficiency virus (HIV) attacks and destroys the infection-fighting CD4 cells (CD4 T lymphocyte) of the immune system. The loss of CD4 cells makes it difficult for the body to fight off infections, illnesses, and certain cancers. Without treatment, HIV can gradually destroy the immune system, causing health decline and the onset of AIDS. With treatment, the immune system can recover. 24 If untreated, an HIV infection may cause acquired immunodeficiency syndrome (AIDS), the most advanced stage of HIV infection. People with HIV who are not on medication and do not have consistent control of their HIV can transmit HIV through bodily fluids exchanged via sex, sharing of needles, pregnancy, and/or breastfeeding. If HIV is controlled, the risk of transmission can be close to zero. 25 For people without HIV, there are several ways to reduce the risk of becoming infected with HIV. Using condoms correctly with every sexual encounter, particularly with partners that are HIV positive with a detectable viral load or with partners whose HIV status is unknown, can reduce the risk of acquiring HIV. Reducing HIV risk also involves limiting and reducing sexual partners and avoiding sharing needles. 26 Pre-exposure Prophylaxis (PrEP) PrEP is an HIV prevention option for people who do not have HIV but who are at risk of becoming infected. PrEP involves taking a specific HIV medicine every day or a long-acting injection. 27 24 U.S. National Institute of Health, Understanding HIV, available at https://hivinfo.nih.gov/understanding-hiv/fact- sheets/hiv-and-aids-basics (last visited Jan. 25, 2024). 25 Id. 26 Id. 27 Id. BILL: SB 1320 Page 8 HIV Testing Certain health care providers can give an HIV test. HIV testing is also available at many hospitals, medical clinics, substance abuse programs, and community health centers. Getting tested through a professional health care provider is recommended; however, there are HIV self- testing kits available. 28 A rapid self-test is an oral fluid test done entirely at home or in private. A mail-in self-test requires a person to provide a blood sample from a finger-stick, which is then sent to a lab for testing. 29 The federal Centers for Disease Control and Prevention (CDC) recommends that everyone age 13 to 64 get tested for HIV at least once as part of routine health care and that people at higher risk for HIV get tested more often. HIV testing can detect if a person has an HIV infection, but it cannot tell how long the person has had the infection or if the person has AIDS. 30 There are three types of tests used to diagnose HIV infection: antibody tests, antigen/antibody tests, and nucleic acid tests: Antibody tests check for HIV antibodies in blood or oral fluid. HIV antibodies are disease- fighting proteins that the body produces in response to HIV infection. Most rapid tests and home use tests are antibody tests; Antigen/antibody tests can detect both HIV antibodies and HIV antigens (a part of the virus) in the blood; and Nucleic acid tests look for HIV in the blood. How soon each test can detect HIV infection differs, because each test has a different window period. The window period is the time between when a person may have been exposed to HIV and when a test can accurately detect HIV infection. A person’s initial HIV test will usually be either an antibody test or an antigen/antibody test. Nucleic acid tests are very expensive and not routinely used for HIV screening unless the person had a high-risk exposure or a possible exposure with early symptoms of HIV infection. When an HIV test is positive, a follow-up test will be conducted. Sometimes people will need to visit a health care provider to take a follow-up test. Other times, the follow-up test may be performed in a lab using the same blood sample that was provided for the first test. A positive follow-up test confirms that a person has HIV. 28 U.S. National Institute of Health, HIV Testing, Where can someone get tested for HIV?, https://hivinfo.nih.gov/understanding-hiv/fact-sheets/hiv-testing (last visited Jan. 25, 2024). 29 Id. 30 U.S. National Institute of Health, HIV Testing, available at https://hivinfo.nih.gov/understanding-hiv/fact-sheets/hiv-testing (last visited Jan. 25, 2024). BILL: SB 1320 Page 9 HIV Treatment People with HIV should start taking HIV medicines as soon as possible after HIV is diagnosed. For people with HIV who have the following conditions, it is especially important to start taking HIV medicines right away: 31 Pregnancy; AIDS-defining conditions; and Early HIV infection. 32 Antiretroviral therapy (ART) is the use of HIV medicines that reduce the level of HIV in the blood (called viral load). ART is recommended for everyone who has HIV. ART cannot cure HIV infection, but HIV medicines help people with HIV have about the same life expectancy as people without HIV. ART can eliminate the risk of HIV transmission. For mothers with HIV who want to breastfeed, the risk of transmitting HIV through breast milk is less than one percent with the consistent use of ART and an undetectable viral load. People on ART take a combination of medicines (called an HIV treatment regimen) every day (pills) or by schedule (injections). In many cases oral medicines may be combined into a single pill or capsule. There are newer long-acting medicines given by an injection every two months that may be used for some people. 33 FDA Approved HIV Medications The following is a list HIV medicines, by category, recommended for the treatment of HIV infection in the U.S., based on the U.S. Department of Health and Human Services (HHS) HIV/AIDS medical practice guidelines: 34 Nucleoside Reverse Transcriptase Inhibitors (NRTIs): These drugs block reverse- transcriptase, an enzyme HIV needs to make copies of itself. o Abacavir; o Emtricitabine; o Lamivudine; o Tenofovir disoproxil; o Fumarate; and o Zidovudine. Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs): These drugs bind to and later alter reverse-transcriptase. o Doravirine; o Efavirenz; o Etravirine; o Nevirapine; and o Rilpivirine. 31 U.S. National Institute of Health, When to Start HIV Medicines (rev, Aug. 16, 2021) available at https://hivinfo.nih.gov/understanding-hiv/fact-sheets/when-start-hiv-medicines (last visited Jan. 25, 2024). 32 Id. Early HIV infection, also known as acute HIV infection, is the period up to six months after a person is infection with HIV. 33 Id. 34 U.S. National Institute of Health, FDA-Approved HIV Medicines, available at https://hivinfo.nih.gov/understanding- hiv/fact-sheets/fda-approved-hiv-medicines (last visited Jan. 25, 2024). BILL: SB 1320 Page 10 Protease Inhibitors (PIs): These drugs block HIV protease, an enzyme HIV needs to make copies of itself. o Atazanavir; o Darunavir; o Tosamprenavir; o Ritonavir; and o Tipranavir. Fusion Inhibitors: These drugs block HIV from entering the CD4 T lymphocyte (CD4 cells) of the immune system. o Enfuvirtide. CCR5 Antagonists: These drugs block the CCR5 co-receptor on the surface of certain immune cells that HIV utilizes to enter the cells. o Maraviroc. Integrase Strand Transfer Inhibitor (INSTIs): These drugs block HIV integrase, an enzyme HIV needs to make copies of itself. o Cabotegravir; o Dolutegravir; and o Raltegravir. Attachment Inhibitors: These drugs bind to the gp120 protein on the outer surface of HIV, preventing HIV from entering CD4 cells. o Fostemsavir. Post-attachment inhibitors: These drugs block CD4 receptors on the surface of certain immune cells that HIV utilizes to enter the cells. o Ibalizumab-uiyk. Capsid Inhibitors: These drugs interfere with the HIV capsid, a protein shell that protects HIV's genetic material and enzymes needed for replication. o Lenacapavir. Pharmacokinetic Enhancers: These drugs are used in HIV treatment to increase the effectiveness of an HIV medicine included in an HIV treatment regimen. o Cobicistat. Combination HIV Medicines: These medicines contain two or more HIV medicines from one or more drug classes. Side Effect of HIV Medication Adverse effects have been reported with all ART antiretroviral (ARV) drugs. As ART is recommended for all patients regardless of CD4 T lymphocyte (CD4) cell count, and because therapy must be continued indefinitely, the focus of patient management has evolved from identifying and managing early ARV-related toxicities to individualizing therapy to avoid long- term adverse effects, including: Diabetes and other metabolic complications; Atherosclerotic cardiovascular disease; Kidney dysfunction; Bone loss; and Weight gain. BILL: SB 1320 Page 11 To achieve and sustain viral suppression over a lifetime, both long-term and short-term ART toxicities must be anticipated and managed. When selecting an ARV regimen, clinicians should consider potential adverse effects, as well as the patient’s comorbidities, concomitant medications, and prior history of drug intolerances. 35 HIV and Opportunistic Infections, Coinfections, and Conditions Opportunistic infections (OIs) are infections that occur more often or are more severe in people with weakened immune systems than in people with healthy immune systems. People with weakened immune systems include people living with HIV, as HIV damages the immune system. A weakened immune system makes it harder for the body to fight off OIs. HIV-related OIs include: Pneumonia; Salmonella infection; Candidiasis; Toxoplasmosis; and Tuberculosis. For people with HIV, the best protection against OIs is to take HIV medicines every day. HIV medicines prevent HIV from damaging the immune system. Because HIV medicines are now widely used in the United States, fewer people with HIV get OIs. 36 III. Effect of Proposed Changes: SB 1320 creates s. 465.1861, F.S., authorizing a pharmacist to order and dispense HIV drugs under a “collaborative practice agreement,” or CPA, with a medical or osteopathic physician. The bill defines the following terms: “HIV” means the human immunodeficiency virus; “HIV infection prevention drug” means preexposure prophylaxis, postexposure prophylaxis, and any other drug approved by the U.S. Food and Drug Administration for the prevention of HIV infection as of March 8, 2024; “Postexposure prophylaxis” to mean a drug or drug combination that meets the clinical eligibility recommendations of CDC guidelines for antiretroviral treatment following potential exposure to HIV issued as of March 8, 2024. “Preexposure prophylaxis” means a drug or drug combination that meets the clinical eligibility recommendations of CDC guidelines for antiretroviral treatment for the prevention of HIV transmission issued as of March 8, 2024. The bill authorizes a pharmacist to screen an adult for HIV and provide the results to that adult without a CPA. If the results of the screening are positive, the pharmacist must advise the patient that he or she should seek further medical consultation or treatment from a physician. 35 U.S. National Institute of Health, Do all HIV medicines cause the same side effects?, Limitations to Treatment Safety and Efficacy, Adverse Effects of Antiretroviral Agents, available at https://hivinfo.nih.gov/understanding-hiv/fact-sheets/hiv- medicines-and-side-effects (last visited Jan. 26, 2024). 36 U.S. National Institute of Health, HIV and Opportunistic Infections, Coinfections and Conditions, What is an Opportunistic Infection? available at https://hivinfo.nih.gov/understanding-hiv/fact-sheets/what-opportunistic-infection (last visited Jan. 25, 2024). BILL: SB 1320 Page 12 The bill requires that for a pharmacist to order or dispense HIV prevention or treatment drugs under a CPA, the pharmacist must be certified by the BOP to: Hold an active and unencumbered license to practice pharmacy; Be engaged in the active practice of pharmacy; Have a Ph.D. degree in pharmacy or have completed at least 5 years of experience as a licensed pharmacist; Maintain at least $250,000 of liability coverage, or liability coverage. Have completed a course approved by the BOP, in consultation with the Board of Medicine and the Board of Osteopathic Medicine, which includes, at a minimum, instruction on all of the following: o Performance of patient assessments: o Point-of-care testing procedures: o Safe and effective treatment of HIV exposure with HIV infection prevention drugs, including, but not limited to: Consideration of the side effects. The patient’s diet and activity levels. o Identification of contraindications; o Identification of comorbidities in individuals with HIV requiring further medical evaluation and treatment, including: Cardiovascular disease; Lung and liver cancer; Chronic obstructive lung disease; and Diabetes. The bill requires the BOP to adopt rules to implement the bill’s provisions. The bill provides an effective date of July 1, 2024. IV. Constitutional Issues: A. Municipality/County Mandates Restrictions: None. B. Public Records/Open Meetings Issues: None. C. Trust Funds Restrictions: None. D. State Tax or Fee Increases: None. BILL: SB 1320 Page 13 E. Other Constitutional Issues: None. V. Fiscal Impact Statement: A. Tax/Fee Issues: None. B. Private Sector Impact: To the extent that pharmacists provide HIV testing or become certified and enter into CPAs with physicians under the bill, HIV testing and treatment might become more accessible. C. Government Sector Impact: None. VI. Technical Deficiencies: None. VII. Related Issues: Unlike the current statutory provisions for a “collaborative pharmacy practice agreement” relating to treatment of chronic conditions found in s. 465.1865, F.S., the bill does not define a “collaborative practice agreement” nor provide requirements for what the agreement must contain or what form it must take. Notable differences can be found between the two agreements in the following examples of requirements for a CPPA that are not required for a CPA: Must be in writing and signed by both practitioners. Applies only to the collaborating physician’s patients who are named in the agreement. Mandatory terms-and-conditions and contents. Duration limitations unless renewed. Provisions for termination of the agreement. Certain actions prohibited. Employer permission (if applicable). Continuing education. Record-keeping. VIII. Statutes Affected: This bill creates section 465.1861 of the Florida Statutes. BILL: SB 1320 Page 14 IX. Additional Information: A. Committee Substitute – Statement of Changes: (Summarizing differences between the Committee Substitute and the prior version of the bill.) None. B. Amendments: None. This Senate Bill Analysis does not reflect the intent or official position of the bill’s introducer or the Florida Senate.