CONNECTICUT MEDICAL ASSISTANCE DUR BOARD MEETING MINUTES SUMMARY CMS FFY 2003

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CONNECTICUT MEDICAL ASSISTANCE DUR BOARD MEETING MINUTES SUMMARY CMS FFY 2003 DUR BOARD MEMBERSHIP 10/01/2002 to 09/30/2003 Kenneth Fisher, R.Ph. (Chair), Dennis Chapron, M.S., R.Ph., Richard Gannon, PharmD., Lori Jane Duntz Lord, R.Ph, Keith Lyke, R.Ph., Kathryn Mashey, DPM, Arturo Morales, M.D., Mike Moore, R.Ph., Frederick Rowland, M.D. SUMMARY OF DUR MEETING MINUTES December 12, 2002 Meeting Minutes Summary The meeting opened by welcoming the two new DUR Board members: Richard Gannon and Dennis Chapron. A review of the By-Laws and a reminder to the DUR Board members to submit their signed disclosure statements before the end of the meeting was addressed. Progress report was given on the development of a new DUR Website. The idea of re-instituting subcommittees to perform workgroup-type functions was discussed but received little Board support. Two Board members agreed to review the draft website and make suggestions instead of creating a subcommittee. June 2002 minutes still packed in a box and unavailable for final approval. Sept 2002 minutes approved as is. Monthly RetroDUR activity reports of patient profiles were reviewed. Michelle Laster-Bradley, ACS explained the Lock-In RetroDUR review program including selection of recipient for profile reviewing and possible lock-in to one pharmacy. Recipients with confirmed overuse by a Medical Review Committee are warned, then locked-in. RetroDUR program goals and provider educational materials were discussed. March 14, 2003 Meeting Minutes Summary The State of Connecticut Medical Assistance program website was announced as now being operational: www.ctpharmacyprogram.com ACS State Healthcare will post to and support the website at the direction of the State of Connecticut. The website contains all pharmacy program-related information, a Retrospective DUR section, a separate Prior Authorization section, and disclaimers. The State of CT Department of Social Services emphasized that all DUR functions are federallymandated and will be kept completely separate from the current state-mandated Prior Authorization program or any other new state-mandated initiative. DUR Board members were told that their names, professional degrees, and meeting minutes will be posted to the website. June 2002 DUR Board meeting minutes should be located for the June 2003 meeting. December 2002 minutes were NOT approved. The Board voted to postpone voting on acceptance of December 2002 meeting minutes because DUR Board members wanted more time to review. The DUR Board made the following requests: That they receive meeting packets 2 weeks in advance so that the Board has time to review, study, research and reasonably react to criteria, meeting minutes and other items presented.

continued Meeting Minutes Summary That ACS State Healthcare and DSS privacy attorneys discuss the information that is being sent out to providers to ensure that the letters being sent are in compliance with all relevant privacy and OBRA 90 DUR rules. Especially clarification, in writing, from the DSS and/or ACS privacy attorneys about whether state privacy laws allow disclosure of HIV, drug addiction, and psychotherapy treatment information on recipient profiles mailed with DUR intervention letters to prescribers. The following categories for criteria reviewed were: Overutilization, Drug-Drug Interactions included in Tramadol s black box warning on increased seizure risk with certain drugs; Cost Effectiveness, Overutilization - Inappropriate Duration, Duplication, and. (See Appendix A for specific criteria). One provider profiling criterion was reviewed and approved: Extended Use of PPI s Post-Hospitalization All newsletters will be posted to the website as developed. A Quarterly Newsletter was reviewed and approved with modifications. Newsletter topic: acetaminophen (APAP) Overuse defined as chronic daily doses greater than 4 grams more than 30 days. Target Audience: Prescribers & Pharmacies involved in recipients who hit the criteria for acetaminophen overuse. The Board was given one month to review and send any additional comments for this newsletter by e-mail or fax to Dr. Laster-Bradley. 4 th Quarter 2002 statistical activity summary report was presented. The report contained: Distribution of Cases, Intervention Topics for Regular RDUR & a Prescriber Response Summary. An average of 1,000 patient profiles are reviewed under the regular DUR program and about 500 patient profiles are reviewed under the Lock-In DUR program every month as part of the RetroDUR contract. Top Classes Report was presented Lock-In Selection Report was reviewed and how patients are selected for review for possible Lock-In to a single pharmacy was explained. June, 2003 Meeting Minutes Summary The June 2002 approved minutes were located and were re-approved as is by the DUR Board. September 2002 meeting minutes were approved as is. December 2002 minutes will be presented at the December 2003 Meeting. March 2003 meeting minutes were approved as amended. Jim Zakszewski, pharmacist for CT Dept of Social Services reminded DUR Board members and attendees that the new CT pharmacy program website was available: www.ctpharmacyprogram.com Four On-site statewide provider educational training programs occurred between May 2 and June 4 with 3 hours of live-continuing Education available. There were three 50-minute sections: Retrospective DUR, Medical Audits, and Prior Authorization Training packets were given to each DUR Board member in their meeting packets. Highlights reported included: - Training packets available from ACS State Healthcare if providers couldn t attend - The Medical Auditor told providers at training that: Medicaid law will not permit cash payments by clients. The DUR Board suggested that ACS post this statement on the website. - The Lock-In program was explained to many providers for the first time. Recipients are given warnings before being locked-in to a pharmacy of their choice.

Attachment 4 continued Meeting Minutes Summary Other DUR Educational Intervention Materials Report Three mailings were conducted where retrospective analyses were used. The letter content was presented to the Board as an FYI only. However, it was emphasized that the RetroDUR Board had nothing to do with PA mailings or with the PA program and that only RetroDUR decisions were made in these Board meetings. The mailings were in preparation for the CT Medical Assistance Pharmacy Prior Authorization Program implementation date of July 16, 2003. The mailings were as follows: Announcement Letter about Pharmacy Prior Authorization implementation. Prescribers, pharmacies and recipients who had received greater than 2 prescriptions in the most previous 90 days were mailed a letter describing the Pharmacy Prior Authorization Program. Two Targeted Letter mailings about CT Medical Assistance Pharmacy Prior Authorization Program implementation. Prescribers and pharmacists who had dispensed, and recipients who had taken Brand medications with at least 2 A -rated generics available or who had obtained early refills were identified and mailed letters. RetroDUR Activity Report Statistical Activity Summary Report RetroDUR intervention activity by month for the past several months was reported. Dr. Laster-Bradley explained that ACS, as the contractor, normally reviewed an average of about 1,000 patient profiles under the regular RetroDUR program and about 500-800 patient profiles under the Lock-In DUR program. Due to the DSS attorney s concern about disclosure of prescription and diagnoses information to patient s prescribers, only one RetroDUR intervention had occurred since HIPAA privacy rules went into effect April 15, 2003. The Board was advised that the DSS attorney was aware that RetroDUR interventions (where letters and patient profiles are sent to prescribers identifying potential problems) have been required and conducted for 13 years by OBRA 90. However, the attorney wanted to send limited, partial drug information and no diagnoses. The Board felt very strongly that all prescription and medical history available was necessary and devised a Position Statement to give to DSS. (See Position Statement). The Board also requested that the position statement be included in the CMS Annual Report. The Board specifically asked that the Position Statement be included in Attachment 6 in the section describing Connecticut s RetroDUR program to warn CMS that restricted information may be provided in the near future as a result of HIPAA and how opposed they were to restricted information. CMS Federal Fiscal Year 2002 Annual Report The RetroDUR portion of the annual CMS report for 2002 was presented along with cost savings by month (or each RetroDUR intervention). Savings on each topic of intervention were as follows: Intervention Month Regular RetroDUR Program Topic Savings/ Recip Intervened Jun 02 Inappropriate Use of Long-Acting Benzodiazepines in Elderly (Clonazepam) $219.38 Jul 02 Inapprop. Use of long-acting Benzos in Elderly (CDP, diazepam, flurazepam) -$1.11 Jul 02 Overuse: Chronic xs use of APAP-containing pain relievers (> 4 grams per day) $363.12 Aug 02 Overuse: Long term use of antibiotics with no supporting diagnosis $308.73 Sep 02 Overuse: Chronic overuse of Butalbital-containing products (daily > 3mo) $-387.88 Sep 02 Duplication of Cox-2 Inhibitors $214.65 Sep 02 Chronic Use of carisoprodol & history of alcohol or drug abuse $486.92 Total Savings in 4 months of Regular RetroDUR: $265,920.30

Attachment 4 continued Meeting Minutes Summary September, 2003 Meeting Minutes Summary December 2002 meeting minutes were approved as amended. June 2003 meeting minutes were approved as amended. An update on the HIPAA privacy issues was given by Terry Wheeler, B.S., J.D., ACS State Healthcare. The Board was informed of a conference call that took place in July with ACS and the DSS attorney Phyllis Hyman. Both sides decided to continue working the programs with the distribution of information as it had been prior to HIPAA. Terry Wheeler gave a brief overview of the Prior Authorization (PA) program discussing which situations would warrant a PA as well as what forms or documents are necessary to obtain a PA. A question and answer session followed suit. A listing of previously approved criteria was presented. Ms. Wheeler pointed out that there were still interventions left from that list that could last the retrodur department through the end of the year. Three other possible interventions (new criteria) were then presented and discussed by the Board. The following were approved: o Heart Failure Therapy and the use of beta-blockers as October s intervention cycle. o Use of ACEIs in diabetic patients to prevent kidney damage as November s intervention cycle. o Underutilization of beta-blockers in post MI patients as December s invention cycle. Use of the drug Tarka [verapamil/trandolapril] was introduced for its possible role in the November intervention. Since the clinical evidence does not currently support this indication, it was not included however Board members will be provided with a report as it relates to diabetics in the future. Second quarter Activity Reports and Quarterly Utilization by Program Reports were reviewed Questions from the Board regarding the Lock-In program and guidelines for which physicians could recommend patients to the program were considered resulting in a request for a newsletter containing this information on the website. The Board requested data for drugs with narrow therapeutic indexes such as warfarin and digoxin as well as information on hospitalizations that could have been caused by certain drug combinations resulting in arrhythmias, hyperkalemia, and hypoglycemia such as glyburide/bactrim, digoxin/biaxin, and ACEIs containing potassium-sparing diuretics. Other future intervention possibilities include: o If sudden death occurred in diabetics who were using atypicals o o o Use of warfarin in patients with a diagnosis of atrial fibrillation Potential precipitator effects of nonsteroidal prescriptions patients with CHF or Renal Insufficiency If patients on Prilosec [prior to its OTC status change] were switched to another PPI that is covered by Medicaid Lastly, Evelyn Dudley from DSS verified that the bylaws pulled from ACS P drive with an original date of January 1993 and a revision date of March 2002 is the most current and correct version. A copy of this version was given to all Board members present.

Attachment 4.B Connecticut Retro Additions, Deletions, & Changes FFY2003 September 2002 CMS Category Board Long-Term Use of Antibiotics without diagnosis to support Overutilization Approved Sumatriptan use with diagnosis of hypertension Inappropriate use Tabled Long term use of Proton Pump Inhibitors Overutilization Tabled Dose optimization of Statins, PPI, and COX II Cost Effectiveness Approved Incorrect billing quantities Pharmacy Profiling Approved December 2002 & March 2003 CMS Category Board Long term use of Proton Pump Inhibitors Overutilization Revised Tramadol Overutilization Overutilization Tramadol Use with History of Drug Abuse Overutilization Reject Tramadol/ SSRI Serotonin Syndrome Drug-Drug Interaction Reject Tramadol/CNS Depressants Drug-Drug Interaction Reject Tramadol / Warning of Increased Seizure Threshold Risk Drug-Disease (Black Box Warning) Reject Tramadol/Drugs with Increased Seizure Threshold (Board decided that this criterion was more useful than above) Drug-Drug Interaction Tramadol/Intracranial Disease and Drug Withdrawal Drug-Disease Interaction Reject Tramadol/Drugs which Inhibit CYP2D6 Drug-Drug Interaction Tabled Tramadol/Naloxone Drug-Drug Interaction Reject Tramadol/Digoxin Drug-Drug Interaction Reject Tramadol/Warfarin Drug-Drug Interaction Reject Risperidone/Antihypertensives Drug-Drug Interaction Reject RDUR too late by the time this happens Risperidone/Antihistamines Drug-Drug Interaction Reject Convert Flovent and Serevent to Advair Cost Effectiveness Aciphex/General Medicines/ Single Daily Dose Cost Effectiveness Reject March 2003 Board CMS Category Addition of Zetia to HMG therapy when patient is taking highest recommended dose and does not meet target LDL goal or exceeds recommended dose. Tabled - Table until have better clinical data Indiscriminant use of COX2s in young patients w/ no GI dx history Inappropriate Therapy/ OverUse Dose Optimization of Aricept Cost Effectiveness Clopidogrel / Atorvastatin Drug-Drug Interaction Reject Diabetes /ACE inhibitors Post MI Drugs/ MI (ICD-9 s)/ Beta Blockers Atrial Fib. Drugs &/or Atrial Fib. ICD-9 s / Coumadin Inappropriate Therapy Long Term Use of PPIs After Inpatient Discharge Overutilization Duplicate/Triplicate PPIs or Duplicate or Triplicate COX2 s Duplication

Attachment 4.B - continued - Connecticut Retrospective June 2003 CMS Category Board No Criteria Presented in June 2003 September 2003 Heart Failure Therapy (in general) and the Use of Beta- Blockers Adding ACE Inhibitors in Diabetics to preserve kidney function Adding Beta-Blocker Therapy in Post-MI patients CMS Category Board

CONNECTICUT MEDICAL ASSISTANCE RETROSPECTIVE DUR CRITERIA Attachment 4-B Criteria Bank - Approval Process CMS FFY 2003 INAPPROPRIATE DOSE THERAPEUTIC DUPLICATION DRUG ALLERGY INTERACTION 1. Lipid Lowering Agents/Dose Optimization* 1. (ACS)_Valdecoxib and other Cox II Inhibitors* 1. NONE 2. #566 Sonata & Ambien/Geriatric Dose 2. (ACS) Multiple Narcotics Agents* 2. 3. #571 Mid Range Analgesics/Overuse* 3. _(ACS#3) PPIs and PPIs/H2 Antagonists*_ 3. 4. #585 Diphenoxylate-Atropine/Overuse* 4. 4. 5. #642 Butalbital/Overuse* 5. 5. 6. #569 Buspirone/Overuse* 6. 6. 7. #606 Migraine Specific Meds/Overuse* 7. 7. 8. (ACS) Butalbital Use > QD Average* 8. 8. INAPPROPRIATE DURATION DRUG/DRUG INTERACTION DRUG DISEASE CONTRAINDICATION 1. #564 Sedatives/Duration* 1. #558 Thioridazine/ Certain Beta Blockers* 1. Thioridazine/QT Syndrome* 2. #638 Carisoprodol & Meprobamate/Duration* 2. #559 Thioridazine/SSRI s* 2. Sedative-Hypnotics/Depression* 3. (ACS) Chronic xs APAP Cont. Pain Relievers3. #565 Sonata/Potent Enzyme Inducers* 3. Protease Inhibitors/Diabetes* _ 4. (ACS) Long Term Use Of Antibiotics:NoDx* 4. #584 Triazolam/Rifampin* 4. Famotidine/Renal Insufficiency* 5. (ACS) Long Term Use Of Narcotics: No Dx* 5. HID Protease Inhibitors/Lovastat&Simvastatn* 5. HID Narcotics & Carisoprodol/Drug Abuse* 6. Chronic Overuse of APAP Cont. Pain Relievers 6. HID Controlled Subst/Drug Depdence(add LI crit.)* 7. 7. (ACS) Carisoprodol & Hx of Alcohol/Drug Abuse* 8. 8. (ACS) Narcotics & Hx Alcohol/Drug Abuse/Depnd* OTHER: COST APPROPRIATENESS OTHER: THERAPEUTIC APPROP. OTHER: GENERIC APPROPRIATENESS SPECIFY SPECIFY SPECIFY 1. NONE 1. #586 Clozapine & Olanzapine/Diabetes* 1. NONE 2. 2. #641 Benzo-Anxiolytics/Approp.Geriatric Meds* 2. 3. 3. #590 Barbiturate Sedatives/AppropGeriatric Med* 3. 4. 4. #591 Teritary TCA's/Appropriate Geriatric Meds* 4. 5. 5. #592 Linezolid/Myleosuppression* 5. 6. 6. #604 Famotidine/Appropriate Geriatric Meds* 6. 7. 7. #604 Famotidine/Appropriate Geriatric Meds* 7. FOR EACH PROBLEM TYPE LIST (DRUGS / DRUG CATEGORY / DISEASE COMBINATIONS) FOR WHICH DUR BOARD CONDUCTED IN-DEPTH REVIEWS. PLEASE INDICATE WITH AN ASTERICK THOSE FOR WHICH CRITERIA WERE ADOPTED.