3120doc.fm

Florida Administrative Weekly
Volume 31, Number 20, May 20, 2005
5. Subsection 64B16-27.104(5), F.A.C., is amended to read: The Board shall not register a prescription departmentmanager as the manager of more than one pharmacy. The Board shall grant an exception to this requirement upon (1) In accordance with the provisions set forth in this rule, application by the permittee and the prescription department a business may purchase books of instant lottery tickets manager showing circumstances such as proximity of permits directly from the Florida Lottery at a discounted price. For and limited pharmacist workload that would allow the manager purposes of this rule, the term “business” shall include, but not to carry out all duties and responsibilities required of a be limited to, the following: for-profit businesses; non-profit, charitable and civic organizations; trade or other associations.
6. Rule 64B16-27.210, F.A.C., introductory paragraph is Businesses that participate in the program shall be known as amended to read: Pursuant to the authority of the Formulary Committee in Section 465.186, F.S., a pharmacist may order (2) To be eligible to receive a discounted price, the the medicinal drug products listed in Rule 64B16-27.220, F.A.C., subject to the following terms and limitations: (a) Must not be a current Florida Lottery retailer; (b) Must purchase and use the tickets within the state of PROPOSED RULE IS: Lucy Gee, Acting Executive Director, Board of Pharmacy /MQA, 4052 Bald Cypress Way, Bin #C04, (c) Must use the tickets only for incentive programs or other stated promotional purposes subject to approval by theLottery. Upon placing an order with the Lottery, the business DEPARTMENT OF HEALTH
partner shall describe the promotional purposes for which the Board of Respiratory Care
ordered tickets will be used on Order Form DOL-466, Effective 05/05, for review and approval or disapproval by the Lottery. Order Form DOL-466 is hereby incorporated by reference and may be obtained from the Florida Lottery, Business Development Unit, 250 Marriott Drive, Tallahassee, Notice is hereby given that the above proposed rule (3) The percentage discount applied to the retail value of a development, as noticed in Vol. 31, No. 14 of the April 8, 2005 book of instant lottery tickets shall be based on the total retail issue, Florida Administrative Weekly, has been withdrawn.
value of full books purchased by the business partner asfollows: Total Retail Value of Books Percentage Discount applied to BOARD OF TRUSTEES OF THE INTERNAL
IMPROVEMENT TRUST FUND
Pursuant to Chapter 2003-145, Laws of Florida, all notices for the Board of Trustees of the Internal Improvement Trust Fundare published on the Internet at the Department of In January of each year, the Florida Lottery will begin tracking Environmental Protection’s home page at http://www.dep.
the total retail value of books of instant lottery tickets state.fl.us/ under the link or button titled “Official Notices.” purchased by a business partner during the calendar year. Asnew orders are placed by the business partner, the Florida DEPARTMENT OF THE LOTTERY
Lottery will apply the applicable percentage discount shown in the table above to the cumulative retail value of books SUMMARY OF THE RULE: This emergency rule sets forth (4) Upon placing its first order with the Lottery, each the provisions for the Business Partner Program in which business partner shall execute a Business Partner Program Florida businesses may purchase books of instant tickets Participation Form DOL-465, Effective 05/05, acknowledging directly from the Florida Lottery at a discounted price.
its understanding of the terms of the Business Partner Program and designating persons authorized to purchase Florida Lottery EMERGENCY RULE IS: Faith L. Schneider, Legal Analyst, products. Business Partner Program Participation Form Department of the Lottery, 250 Marriott Drive, Tallahassee,Florida 32399-4011 Florida Administrative Weekly
Volume 31, Number 20, May 20, 2005
DOL-465 is hereby incorporated by reference and may be Capsules; Valcyte; OxyContin; and IVIG. AHCA may add obtained from the Florida Lottery, Business Development Unit, other drugs to the list of drugs requiring prior authorization if 250 Marriott Drive, Tallahassee, Florida 32399-4047.
abuse or misuse has been identified or if AHCA evaluation (5) Lottery tickets sold by the Lottery to a business partner indicates that a newer more, expensive drug has no substantive additional value over existing therapies. With a few exceptions (6) Full payment is due to the Lottery upon delivery of prior authorization requests are made by telephone to the Prior lottery tickets to the business partner. Payment may be made Authorization Help Desk of Affiliated Computer Services by Cashier’s check or business check for tickets delivered to (ACS) in Atlanta at (877)553-7481. The Help Desk approves the business partner by the Lottery. Payment may be made by or denies the request based on Florida Medicaid protocol.
cash if ordered lottery tickets are picked up by the business Forms must be faxed or mailed to ACS Prescription Benefits Manager, Florida Medicaid Clinical Services, 365 Northridge (7) The Lottery assumes no responsibility for tickets that Road, Suite 400, Atlanta, Georgia 30350. The Fax number is are lost, stolen or damaged after purchase.
(8) Business partners are prohibited from distributing A few drugs are prior authorized by the Medicaid Bureau of Florida Lottery tickets outside the state of Florida.
Pharmacy Services. These are Botox, Cytogam, Growth (9) Business partners shall comply with all provisions of Hormone for treatment of HIV/AIDS wasting in Chapter 24, Florida Statutes, as well as rules and regulations adults-Serostim, Myobloc, Panretin, Proleukin, Regranex in heretofore or hereafter promulgated by the Lottery.
long term care facilities, and Targretin Gel and Capsules. Priorauthorization for these drugs may be obtained by calling Specific Authority 24.105(9)(b),(h), 24.109(1) FS. Law Implemented 24.105(9)(b),(h) FS. History–New 5-10-05, Replaces 53ER04-56.
(850)487-4441, faxing the forms to (850)922-0685 or mailingthem to Medicaid Bureau of Pharmacy Services, 2727 E.
Mahan Drive, Mail Stop 38, Tallahassee, FL 32308.
For Regranex, use Pharmacy – Miscellaneous – Prior Authorization Form. When requesting prior authorization, the provider must provide recipient data consisting of therecipient’s name, ten-digit Medicaid identification number, and AGENCY FOR HEALTH CARE ADMINISTRATION
date of birth; prescriber data consisting of prescriber’s name, Medicaid
mailing address, telephone and fax numbers and professional license number; pharmacy data consisting of the pharmacy’s Prescribed Drug Prior Authorization Process provider number, address, and telephone and fax numbers; SPECIFIC REASONS FOR FINDING AN IMMEDIATE drug data consisting of the drug name, strength, dosage form, NDC code, and quantity needed; and drug justification WELFARE: The immediate implementation of this rule consisting of required justification of the patient’s need for the provides procedures for the prior authorization process which is necessary for the Agency to manage the prescribing of Actiq is approved for the treatment of acute pain, secondary to certain dangerous drugs to avoid harm to patients.
cancer in opioid tolerant patients. The Food and Drug Administration required the manufacturer of Actiq to include a IS FAIR UNDER THE CIRCUMSTANCES: Patient safety is black box warning before any other information stating that Actiq is indicated only for breakthrough cancer pain.
SUMMARY OF THE RULE: This rule establishes a Life-threatening hypoventilation can occur at any dose in mechanism to ensure that certain drugs are prescribed patients not also taking chronic opiates.
according to established clinical guidelines and protocols in Albumin use is approved for the diagnoses of hypoalbuminemia due to acute liver failure, hepatic cirrhosis,nephrotic syndrome, tuberculosis, trauma, or burns. Albumin use will not be approved for caloric supplement or as anadditive to TPN admixture. Approved indications for Aranesp 59GER05-2 Prescribed Drug Prior Authorization Process.
are anemia with renal failure; anemia associated with Drugs requiring a clinical prior authorization are Actiq; chemotherapy. Clinical studies have demonstrated that using Albumin; Aranesp; Botox; Cytogam; Food Supplements; Aranesp to increase the hematocrit above 36 percent increased Fuzeon, Growth Hormone for HIV/AIDS Wasting in the incidence of cardiac events, particularly myocardial Adults-Serostim; Leukine; Myobloc; Neupogen; Neurontin; infarction among renal dialysis patients. For initial therapy Neutrexin; Nexium; Panretin; Procrit; Proleukin; Provigil; patients must meet all three of the following requirements: no Regranex in long term care facilities; Somatropin, rh-GH for active gastrointestinal bleeding; hematocrit less than 33 Growth Hormone Deficient Adults; Targretin Gel and Florida Administrative Weekly
Volume 31, Number 20, May 20, 2005
percent and hemoglobin less than 11; and lab data within two therapy is twelve weeks according to the manufacturer’s months of prior authorization. For continuation of therapy package insert, with a break of eight weeks before patients must meet all three of the following requirements: no re-certification can be considered for approval. A current BIA active gastrointestinal bleeding; hemoglobin of less than 13 must be performed and a copy submitted with all requests for and hematocrit of less than 36 percent; and lab data within 2 renewals. Alternatively, recipient must have a Body Cell Mass (BCM) less than 35 percent for a male or less than 23 percent Medicare covers Botox. Medicaid coverage of Botox is for a female and a Body Mass Index less than 24 or a five approved for children being treated by the Shriner’s clinic only.
percent BCM loss in six months. Dosage must be adjusted It must be prior authorized by AHCA, Bureau of Pharmacy according To recipient’s weight. The recipient must not be Services. Cytogam is approved for the maximum length of pregnant. Medical justification for continuing human growth therapy of sixteen weeks. It will only be approved for hormone for adults can be requested from the physician to recipients who are cytomegalous-seronegative and have had a support additional therapy. For initial therapy or request for transplant from a cytomegalous-seropositive donor.
additional therapy the physician must submit a new prior Nutritional supplements reimbursement is justified as an authorization form with the recipient’s weight chart for the past alternative to admission to a nursing facility or hospital, and six months signed and dated by the physician. Medicaid will will not be approved to augment normal dietary sources of reimburse up to $36,000 per calendar year per recipient.
nutrition. Medicaid will not reimburse for standard infant Subsequent prescriptions must be billed to the National formulas or other supplements without documented medical Organization for Rare Disorders. Fuzeon in combination with need. Before requesting prior authorization for food other antiretroviral agents is indicated for the treatment of supplements, the provider must obtain a written statement from HIV-1 infection in treatment-experienced patients with the physician that includes the recipient’s diagnosis and evidence of HIV-1 replication despite ongoing antiretroviral prognosis; the recipient’s height and weight, and date therapy. Clinical experience with Fuzeon indicates that the measured; the medical justification for using a food overuse of an antiretroviral drug will result in an early supplement over other dietary regimens such as blended or development of viral resistance. Consensus of medical opinion pureed food, fortified milk shakes, puddings, custards, high is that Fuzeon should be reserved for those patients with only a calorie and high protein meals, etc.; and a statement that few choices of antiretroviral drugs left, delaying the without the food supplement the recipient will require development of viral resistance. Leukine is indicated for use institutionalization. If the recipient is younger than five years following induction of chemotherapy in acute Myelogenous of age, the Women, Infants and Children (WIC) program must Leukemia, in mobilization and following transplantation of be used first. This documentation must also be kept on file in autologous peripheral blood progenitor cells in Myeloid the provider’s patient records. This therapy must be prior reconstitution after autologous and allogeneic bone marrow authorized by ACS. Coordination of benefits with the WIC transplantation, and in bone marrow transplantation failure or program is required for children under five years of age and engraftment delay. Myobloc therapy will only be approved if pregnant women. Medicaid authorizations for nutritional the recipient has a diagnosis of cervical dystonia (CD), a supplements can be approved for requirements in excess of neurological disorder that forces a person’s neck and shoulder WIC allocations or if WIC cannot supply the required product muscles into abnormal and sometimes painful movements or and WIC documentation is attached to the prior authorization positions. The physician must provide a written prescription.
request. WIC eligible authorizations are approved for six Each prior authorization request can be approved for a maximum of 16 weeks. It must be prior authorized by AHCA, Growth hormone therapy is currently approved for the Bureau of Pharmacy Services. Neupogen is covered diagnosis of HIV wasting and cachexia in recipients over 18 exclusively for cancer patients receiving myelosuppressive years of age and over. The recipient’s physician must chemotherapy, cancer patients receiving bone marrow coordinate approval for growth hormone therapy for adults.
transplants, acute myeloid leukemia receiving induction or The recipient’s physician must complete, sign and date the consolidated chemotherapy, peripheral blood progenitor cell Serostim Growth Hormone for HIV/AIDS Wasting Prior collection and therapy in cancer patient, severe chronic Authorization (PA) form, including the required test results. A neutropenia, either congenital, cyclic, or idiopathic severe current bioelectric impedance analysis (BIA) test must be neutropenia in AIDS patients on antiretroviral therapy. A lab performed and copy submitted with all requests for renewals.
test (date) and an absolute neutrophil count are required.
The recipient must have experienced at least a 7.5 percent Neurontin is approved for partial/partial complex seizure unintentional weight loss within the past six months for initial disorders, post-herpetic neuralgia, diabetic neuropathy of the approval. The recipient must be currently receiving AIDS lower extremities, and treatment of amyotrophic lateral anti-retroviral therapy. The approval period is for a total of sclerosis (ALS). Unchallenged off-label use of Neurontin ninety (90) days from the start date of therapy. The length of means that patients may have unnecessary delays in receivingdrug therapy that is proven safe and effective for a variety of Florida Administrative Weekly
Volume 31, Number 20, May 20, 2005
diseases. In addition, there have been reports in the lay press of Regranex in long-term care facilities is limited to diabetic increased incidence of suicides associated with the off-label recipients diagnosed with a lower extremity diabetic use of Neurontin. Section 409.912(39)(a)14., F.S.
neuropathic ulcer, and who are taking diabetic medications.
Neutrexin® therapy is approved for the diagnoses of metastatic Regranex® is limited to 15gm per prescription for a maximum carcinoma of head and neck, metastatic colorectal of 140 days per year. Somatotropin approval requires growth adenocarcinoma, and refractory pneumocystis carinii hormone deficiency confirmed by a growth hormone pneumonia (PCP) and a failure of or intolerance to stimulation test or insulin tolerance test. When a dose sulfamethoxazole-trimethoprim. The provider must document adjustment is requested, a recent IgF level must be provided.
previous dosages and clinical response of all previous Growth hormone is contraindicated in the presence of active therapies. Neutrexin will not be approved for prophylactic use.
malignancy. Abrupt cessation of this drug can cause extreme Each prior authorization request can be approved for three swings of the patient’s blood glucose and cortisol levels. To months. The documentation must be kept on file in the ensure continuing coverage growth hormone should be provider’s patient record. Nexium will be approved if a failure approved for growth hormone deficient adults.
of existing therapy is documented and submitted to ACS’s Targretin Gel 1% and capsules coverage is limited to the topical treatment of cutaneous T-cell lymphoma (CTCL) in Panretin is indicated for the topical treatment of Kaposi patients refractory to at least one prior systemic therapy. It is Sarcoma (KS) lesions. It is recommended for use where the not covered for pregnant women and is not indicated for total number of lesions is less than ten and is between two and women who might become pregnant. Height and weight three centimeters (cm) in size. Recipients whose lesions information is required. Vitamin A intake is limited to no more number greater than ten should be on systemic therapy. The than 15,000 IU per day. Valcyte is approved for use in concurrent use with systemic KS treatment is not cytomegalovirus retinitis and cytomegalovirus treatment or prophylaxis in organ transplantation. Valcyte is contraindicated Procrit is covered for anemia associated with renal failure if in peritoneal dialysis, hemodialysis, when the patient’s platelet patient is not on dialysis, anemia associated with HIV infection count of 25,000 or less, hemoglobin is 8 gm/dl or less, or the therapy, anemia associated with chemotherapy, and blood absolute neutrophil count is 500 cells/mm or less. The clinical transfusions, allogeneic, in anemic surgery patients. Lab tests prior authorization helps ensure that recipients do not receive with dates and results are required. It is contraindicated for the drug if the patient’s bone marrow is significantly patients with gastrointestinal bleeding.
Proleukin therapy is currently approved for the diagnoses of Florida Medicaid will allow one strength of Oxycontin per renal cell carcinoma, metastatic melanoma, non-Hodgkin’s 30-day period and a maximum of four tablets per day within a lymphoma, and acute myelogenous leukemia. Dosage and 30-day period of the following strengths: 10mg, 20mg, 40mg frequency of dosing must be provided. Each prior authorization and 80mg. Doses greater that four tablets per day of these request can be approved for a maximum of three months.
strengths will require prior authorization. Doses greater than Provigil will only be approved if the recipient is 15 years of two tablets per day of the 160mg within a 30-day period will age or older and has a diagnosis of narcolepsy or has one of the require prior authorization. Changes in strengths within a two new FDA approved conditions for use: obstructive sleep 30-day period will require prior authorization. Prior apnea/hyponea syndrome or shift work sleep disorder.
authorizations will be given up to six months depending on Approval for treatment of narcolepsy is based upon the clinical medical diagnosis. Therapy exceeding these limits must be interpretation of either of these tests, Multiple Sleep Latency or Maintenance of Wakefulness. The physician must submit Intravenous immunoglobulin therapy (IVIG) will be covered clinical interpretation of either test. Approval for obstructive effective January 2, 2002, by Florida Medicaid for the sleep apnea/hyponea syndrome is based upon the clinical following conditions based specific requirements: interpretation of either Multiple Sleep Latency/Maintenance of immunodeficiency disorders, primary humoral Wakefulness Test or Psychomotor Vigilance Task or Steer immunodeficiency syndromes identified as CVID (common Clear Performance and concurrent use of continuous positive variable) immunodeficiency, X-linked agammaglobulinemia, airway pressure (CPAP) with significant compliance. The SCID (severe combined immunodeficiency), IgM (X-linked physician must submit clinical interpretation of either battery immunodeficiency with hyperimmunoglobulin), of tests and documentation of usage of CPAP. Approval of shift Wiskott-Aldrich Syndrome; and other immunodeficiency work sleep disorder is based upon the clinical interpretation of disorders including idiopathic thrombocytopenic purpura either Multiple Sleep Latency/Maintenance of Wakefulness (ITP), Pediatric Human Immunodeficiency Virus (HIV) and the patient’s night shift work schedule.
Infection. Approved neurological disorders for treatment withIVIG are Guillian-Barre’ Syndrome, relapsing-remittingMultiple Sclerosis, chronic inflammatory demyelinating Florida Administrative Weekly
Volume 31, Number 20, May 20, 2005
polyneuropathy, Myasthenia Gravis, polymyositis and dermatomyositis. Other approved disorders for treatment with Petitions and Dispositions Regarding Rule IVIG are chronic lymphocytic leukemia, bone marrowtransplantation (BMT), Kawasaki Disease (Mucocutaneous Lymph Node Syndrome) autoimmune Hemolytic Anemia andAutoimmune Neutropenia. If a prior authorization request is DEPARTMENT OF LAW ENFORCEMENT
approved, a prior authorization number will be assigned to the The Department of Law Enforcement, Criminal Justice recipient for a specified period of time, based on the prior Standards and Training has taken action on a petition for authorization protocol or the written prescription, whichever is waiver received from William Markham and Bradley Linville.
less. The beginning and ending date of the prior authorization Notice of receipt of this petition was published in the Florida will be provided to the requesting provider, who must record Administrative Weekly, Vol. 31, No. 19, May 13, 2005.
the approved time period for reference purposes. The providerand the recipient must be eligible on the date of service and, should this drug exceed the four-brand limit, the prescriber The petition requested a waiver of subparagraph must have received the exception from the Therapeutic 11B-20.0014(1),(2)(d), F.A.C., pursuant to Section 120.542, Consultation Program (TCP). If a prior authorization is F.S. Petitioner has requested that the Department waive certain approved, the TCP help desk should automatically enter a reporting requirements for instructors.
four-brand over-ride, if applicable. The prior authorization For a copy of the final order write or call: Grace A. Jaye, number will be used by Medicaid to authorize payment for the Florida Department of Law Enforcement, Box 1489, prescription during the approved period. The provider does not Tallahassee, FL 32302-1489, Telephone (850)410-7687.
need to enter the number on the claim. Requests for renewal ofprior authorization must be submitted before an existing prior DEPARTMENT OF HIGHWAY SAFETY AND MOTOR
authorization expires. Medicaid may not reimburse for VEHICLES
prescriptions without an approved renewal. Prior authorization Notice is hereby given that the Department of Highway Safety renewals are obtained by providing current recipient and Motor Vehicles has approved petitions for variance of Rule assessments, updated information (including dosage), and a 15A-10.014, F.A.C., submitted by the following programs: new Prior Authorization Form and written prescription from Northeast Florida Safety Council, filed on March 15, 2005, and DUI Counterattack Hillsborough, filed on March 16, 2005. The Specific Authority 409.919 FS. Law Implemented 409.906(20), 409.908, Department approved the above variances on May 3, 2005.
409.912 FS. History–New 1-1-77, Amended 6-30-77, 10-1-77, 2-1-78, 4-1-78, 9-28-78, 6-1-79, 2-28-80, 11-11-81, 7-3-84, Formerly 10C-7.42, Amended The petitioners were seeking to contribute to their programs’ 3-11-86, 12-5-88, 6-4-90, 10-29-90, 5-20-92, 4-11-93, Formerly 10C-7.042, retirement plan in excess of the percentage of gross Amended 12-28-95, 8-3-97, 2-11-98, 9-13-99, 7-20-00, 1-29-01, 4-24-01, compensation contributed for members of the regular class ofthe Florida Retirement System (FRS). The petition was approved on the basis that the FRS contribution rate for the regular class is at 6.20% this fiscal year due to positive investment performance and the legislature’s decision to spend down the FRS trust fund surplus. There are inherent andsignificant differences in how the FRS fund functions as DEPARTMENT OF ENVIRONMENTAL PROTECTION
compared to the DUI programs’ retirement plans. Therefore, Pursuant to Chapter 2003-145, Laws of Florida, all notices for application of this rule would create a substantial hardship for the Department of Environmental Protection are published on the DUI programs and their employees. Notice of the petitions the Internet at the Department of Environmental Protection’s was published in the FAW on April 15, 2005.
home page at http://www.dep.state.fl.us/ under the link or A copy of the order(s) can be obtained from: Bureau of Driver Education and DUI Programs, Department of Highway Safetyand Motor Vehicles, 2900 Apalachee Parkway, MS 88,Tallahassee, Florida 32399-0571.
Section V - Petitions and Dispositions Regarding Rule Variance or Waiver 1879

Source: https://www.flrules.org/Faw/FAWDocuments/FAWVOLUMEFOLDERS2005/3120/SECTIV.pdf