AUGUST 2000 PROFESSIONAL 00-3 INDEX

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1 PROFESSIONAL 00-3 PAGE ONE PAGE TWO PAGE THREE PAGE FIVE PAGE FIVE INDEX AIR AMBULANCE SERVICES CLOZAPINE MAC PRICING AND CLOZARIL PRIOR AUTHORIZATION FEDERALLY QUALIFIED HEALTH CENTERS PROVIDER NUMBERS HEART, LUNG, AND HEART/LUNG TRANSPLANTS INFLUENZA THERAPY INJECTIONS PNEUMOCOCCAL VACCINE PRIOR AUTHORIZATION OF LONG-TERM USE OF H2 ANTAGONISTS AND PROTON PUMP INHIBITORS PROFESSIONAL SERVICES PROVIDER MANUAL REVISIONS If you have any questions, please contact the Medicaid Customer Service Center at (in-state providers) or (785) between 7:30 a.m. - 5:30 p.m., Monday through Friday. AIR AMBULANCE SERVICES The following guidelines have been made to help clarify services: Time: If time is a critical factor in the patient s recovery or survival, or duration of ground transport would be excessive and potentially detrimental, air transport may be indicated. In general, if the ground ambulance can arrive at the destination institution within 20 minutes, it is the preferred mode of transport. Expertise: If the health care institution does not possess the expertise to provide the

2 definitive care required to stabilize the patient (i.e., advanced life support) and the ground ambulance providers in the near vicinity cannot provide assistance in providing that care, air transport may be indicated.

3 PAGE TWO Coverage: If ground ambulance utilization leaves the service area without adequate ground coverage and patient outcome will be compromised by arranging other ground transport, air transport may be indicated. Documentation: The above guidelines serve as a guide to documentation which is necessary to determine proper reimbursement and must specify the indication and justification for air transport. If guidelines are not met, or are met but not documented, the billed transportation will be reimbursed at ground ambulance rates or denied altogether. CLOZAPINE MAC PRICING AND CLOZARIL PRIOR AUTHORIZATION A generic clozapine manufactured by Zenith Goldline Pharmaceuticals has been available since November Another generic clozapine was released by Mylan Pharmaceuticals earlier this year. Both products received an AB rating from the FDA which means they have been rated bioequivalent and interchangeable with the brand product, Clozaril, on a mg per mg basis. SRS has spoken with the FDA, providers, and representatives of Zenith Goldline. Based on the data received for 22,000+ patients who have received Zenith s clozapine over the last 2.5 years, we are confident there is no difference in the efficacy of generic clozapine over the brand name product. Additionally, SRS received information from both Novartis and Zenith Goldline regarding their registries and we are satisfied that the generic manufacturer provides a level of service that meets or may exceed the services you have come to rely on in the Novartis Clozaril registry. In order to learn more about the effects of switching from Clozaril to a generic, SRS interviewed Kansas Medicaid providers who have personally switched a total of 124 patients from Clozaril to Zenith s clozapine. All patients were switched on a mg per mg basis, with no reports of decompensation or adverse events. SRS also spoke to a national pharmacy services provider that switched nearly 7,000 patients from Clozaril to Zenith s clozapine. Again, the switches were on a mg per mg basis and there were no reports of decompensation or adverse events due to the switch. While efficacy has been found to be the same between generic clozapine and Clozaril, the most notable advantage of the generic products is the cost. Effective July 1, 2000, there will be a state maximum allowable cost (MAC) for clozapine 25mg and 100mg tablets of $0.90 and $1.90, respectively. We believe that these MACs allow providers an equitable profit margin while achieving needed savings for the Medicaid program.

4 PAGE THREE These savings can help stretch Medicaid dollars farther at a time when significant reductions to the pharmacy budget have been mandated by the Legislature and pharmacy costs are increasing at a rate of 20% annually. Additionally, there is a State program that provides atypical antipsychotics to indigent patients who have no insurance and are not eligible for government assistance. Savings like this will make it possible for the State to assist more individuals in need. Therefore, we are asking that all new Medicaid patients placed on clozapine be started on the generic. On and after July 1, 2000, prescription claims for clozapine will pay at the lessor of the MAC, FUL or EAC cost. In most instances, the State MAC will be the lesser of the three. If the prescriber feels it is medically necessary that their patient receive brand name Clozaril, prior authorization may be obtained to pay the claim at the estimated acquisition cost (EAC) by calling the Prior Authorization Unit at New patients must receive a trial of the generic clozapine before a trial of Clozaril will be approved. In addition, we are asking providers to convert their patients from Clozaril to clozapine. The switch is not required. For patients who have been stabilized on Clozaril, we will be sending providers a separate report in the next several weeks listing those individuals. We will give providers at least 90 days to switch these patients to generic clozapine or obtain prior authorization to continue them on Clozaril. Conversion to generic clozapine is virtually transparent to clinicians. The registration process and WBC reporting process is essentially identical to the Clozaril registry. The generic manufacturers will even accept the data when received on various laboratory forms, including Novartis forms. If you are using the Novartis electronic WBC reporting software, Zenith Goldline provides a very similar program at no cost, with full technical support available 24 hours per day. In regards to the product itself, Zenith s clozapine is very similar in appearance to Clozaril in size, shape and color and is available in both 25mg and 100mg tablets. We emphasize that our research and available published literature show that generic clozapine is interchangeable with Clozaril. Tens of thousands of patients nationwide have been switched from Clozaril to generic clozapine with no reports of decompensation attributable to the switch. We respectfully request your cooperation in this process. If you have questions or concerns, please do not hesitate to contact Karen Braman, SRS Consultant Pharmacist at or ksb@srskansas.org. FEDERALLY QUALIFIED HEALTH CENTER PROVIDER NUMBERS Effective with dates of approval on and after September 1, 2000, Federally Qualified Health Centers (FQHC) will not be allowed to enroll as a Local Health Department provider.

5 HEART, LUNG, AND HEART/LUNG TRANSPLANTS Effective with dates of service on and after October 6, 2000, heart, lung and heart/lung transplants require KAN Be Healthy. Out-of-state transplant services for adults prior authorized before October 6, 2000, will be covered. INFLUENZA THERAPY Effective October 1, 2000, prescription drug claims for neuraminidase inhibitors zanamivir (Relenza ) and oseltamivir (Tamiflu ) will be paid for dates of service during the influenza (flu) season only and will be limited to one course of therapy per beneficiary per flu season. According to the Kansas Department of Health and Environment, the Centers for Disease Control consider the flu season in Kansas to be from mid-october through mid-april. One course of therapy for both Relenza and Tamiflu are defined by the company in the package insert as five days of therapy. INJECTIONS The following injections have been non-covered and are no longer billable to Medicaid. J0695 Z2071 J0810 Z2716 J2970 Z2022 J2640 Z2128 J2330 Cefonicid Sodium (Monocid) Cimetidine (Tagment) Cortisone Dexpanthenol Methicillin Sodium (Staphcillin) Naficillin Prednisolone Sodium (Hydeltrasol) Sincalide Thiothixine (Navane) PNEUMOCOCCAL VACCINE Two new pneumococcal vaccines (Prevnar and Pneumovax) are covered for use in children. The recommended schedule is 2, 4, 6 and 12 months. Use procedure code for Prevnar and for Pneumovax.

6 PAGE FIVE PRIOR AUTHORIZATION OF LONG-TERM USE OF H2 ANTAGONISTS AND PROTON PUMP INHIBITORS Effective with dates of service on and after October 2, 2000, H2 antagonists and proton pump inhibitors at acute (maximum) dosing for greater than sixty (60) days will require prior authorization. The acute daily doses are listed below: H2Antagonists: Cimetidine (Tagamet ) = 1500 to 1600mg per day Famotidine (Pepcid ) = 80mg per day Nizatidine (Axid ) = 300mg per day Ranitidine (Zantac ) = 600mg per day Proton Pump Inhibitors: Lansoprazole (Prevacid ) = 30mg per day Omeprazole (Prilosec ) = 40mg per day Rabeprazole (Aciphex ) = 20mg per day Pantoprazole (Prontonix ) = 40mg per day PROFESSIONAL PROVIDER MANUAL REVISIONS Remove Replace With AI-5 - AI-18 AI-5 - AI-18 Bulletins and manuals constitute proof of notification of program changes to Kansas Medical Assistance Program providers. Please read these publications carefully and keep them for future reference.

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