April 21, 2010 DURB Meeting Summary

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Roll Call Present: Dr. Swee, Ms. Olson, Ms. Martinez- Rodriguez, Dr. Barberio, Dr. Gooen, Dr. Gochfeld, Dr. Lichtbroun Absent: Dr. Moore, Dr. Marcus, Mr. Schafer, Dr. Moynihan, Review of Minutes Pages 3-8; Tab 1 Approved Minutes from January 13, 2010 meeting were approved and are posted to the DURB website: http://nj.gov/humanservices/dmahs/boards/durb/meeting/index.html Secretary s Report Page 9-10; Tab 2 Administrative items: Effective immediately Dr. David Condoluci has resigned from the Board. Medical Exception process (MEP) Unit will send medical necessity forms (MNF s) with a reference to the NJDURB website for prescribers seeking information on protocols that are recommended by the Board and approved by the Dept. of Human Services (DHS) and Dept. of Health & Senior Services (DHSS) Commissioners. Newsletters highlighting protocols from quarterly meetings will be posted to the DURB website. One additional correction to the January 13, 2010 transcript was identified by the Board. Page 41, line 13-14 health reforms should read formulations. Clinical items: Both Commissioners of DHS and DHSS approved the Adult Mental Health Protocol recommended by the NJDURB during the October 2009 meeting. Implementation of the protocol will be done in a careful manner so that treatment is not interrupted erroneously.

The NJDURB SFY 2009 Annual Report has been signed by both Commissioners of DHS and DHSS and is in the process of being published in the NJ Register. The NSAID Protocol implementation is on hold until approval is received from both Commissioners of DHS and DHHS. Upcoming DURB meeting dates are scheduled for Wednesday June 23, 2010 and Wednesday October 20, 2010. The meetings will be held from 11 am to 12 pm in Building 7, Conference Rooms 200 A, B, and C at Quakerbridge Plaza Mercerville, NJ 08625. Business A. Tramadol Protocol Pages 11-12; Tab 3 Tabled The Board was provided with an opportunity to review and provide their recommendations regarding the proposed Tramadol Protocol. The protocol was presented by the Division of Medical Assistance & Health Services (DMAHS) to monitor appropriate utilization of tramadol. The Board requested more information such as when are patients prescribed tramadol, number of patients on it, and for how long. A decision was tabled until the Board obtained this information and can be reviewed. B. Familial Dysautonomia (FD) Pages 13-20; Tab 4 Tabled DMAHS is requesting the Board review and provide a recommendation regarding coverage of over-the-counter nutritional supplement green tea capsules for patients with Familial Dysautonomia (FD). EGCG has not been studied in humans to date. The use of this supplement for FD is considered experimental and the indication for its use in FD is not FDA approved. The Board requested more information such as: other States experiences with coverage of this product, studies through NIH involving green tea capsules/egcg, and cost per patient to the State of NJ in order to reach a recommendation.

Pharmaceutical Research and Manufacturers of America (PhRMA)- Informational Highlights 1. Atypical Antipsychotic Use 2. Nicotine Utilization Report 3. Unisys (Fee-for- Service) Clinical Interventions Report No page or tab numbers associated with this action item Approved The Board recommended the following: (1) PhRMA is encouraged to present during the NJDURB meetings upon request of additional information by the Board; (2) in order to obtain all information necessary from presenters no time limit was set nor was there a maximum to the number of presenters; and (3) if PhRMA requested to present on a particular topic (related or unrelated to the agenda items) they could submit the names of the presenters and the information being presented in advance to the Board Chairman and Secretary at which time the topics will be considered and scheduled for the NJDURB meeting. Pages 21-26; Tab 5 Utilization reports for December 2009 for atypical antipsychotic use in the Aged, Blind, and Disabled (ABD) Population were reviewed. Over $80 million is spent annually on antipsychotic medications. Page 27; Tab 6 A report covering January 2008 to January 2010 utilization of nicotine inhalers, patches, chewing gum, and lozenges was reviewed. The report summarized the number of days patients were on nicotine products and the number of patients in 5 duration intervals. (<50 days to >300 days). The report did not seem to demonstrate overutilization. Pages 29-30; Tab 7 A summary report of Clinical Interventions by the Unisys Medical Exceptions Program (MEP) for February 2010 was reviewed. There were 34,339 prior authorization requests and 4,465 (13%) denials. The top five categories of denials were: (1) therapeutic duplication; (2) awaiting return of MNFs from prescribers; (3) prescriber changed to OTC product; (4) incorrect prescription days supply processed by the pharmacists; and (5) excessive dose.

4.Tops Drugs Report Pages 31-36; Tab 8 A report of the top drugs, by dollar amount, for February 2010 was reviewed. Atypical antipsychotics and HIV drugs are among the most frequently prescribed and most expensive products. 5. HMO Denial Reports Pages 37-41; Tab 9 Quarterly reports from AmeriChoice, AmeriGroup, Health Net of N.J., Horizon NJ Health and University Health were reviewed. (DMAHS had previously requested that the HMOs provide clarification regarding their denial categories. The HMOs were asked to list all categories separately such as clinical criteria not met and unacceptable diagnosis.) The denials rates were 28.2%, 37.1%, 31.7%, 43.2, and 45.7% respectively, compared to Unisys MEP at 13%. Follow-up Items from previous NJDURB meetings Mandatory Generic Policy DMAHS will present the exempted list of drugs to the Board for their review & clinical input. DMAHS will request that the Board provide a recommendation as to whether or not the drugs on the current list should be exempted or included from the policy. Reports on Protocols DMAHS will provide the Board with reports pertaining to approved protocols. HMO Denial Reporting DMAHS will request that the HMOs provide the total number of claims processed for each quarter in addition to the report they submit. All of the requested information may not be available to the Board until contractual changes occur between the State and HMOs.

Retro-DUR Compliance The State will be working with Unisys to set up a process by which Notification compliance letters can be sent to patients prescribers concerning specific disease states. The disease states of interest include Asthma, Diabetes, Hypertension, Warfarin, and HIV-AIDS. DMAHS has also requested a Retro-DUR project related to atypical antipsychotics. The Board has requested this be presented as a formal agenda item to prioritize the projects. Medical Diagnosis Data The Division will provide a report consisting of top diagnosis for the FFS Medicaid population based on medical claims data. This information may be useful in comparing to the top drugs utilized within this population.