State of California DEPARTMENT OF HEALTH CARE ... -...

MEDI-CAL DRUG USE REVIEW (DUR) BOARD

State of California DEPARTMENT OF HEALTH CARE SERVICES

Notice is hereby given that the Medi-Cal DUR Board will conduct a public meeting on Tuesday, February 21, 2017, at the following location:

Conduent 840 Stillwater Road, Mendocino Room

West Sacramento, CA 95605

Medi-Cal Drug Use Review Board Meeting Agenda

February 21, 2017 9:30 AM-12:30 PM

Report Type*

Agenda Item Presenter Time

C

1. Welcome/Introduction

Pauline Chan, RPh, MBA 930-935

A 2. Call to Order/Review and Approval of Previous Minutes from November 15, 2016

Robert Mowers, PharmD 935-940

3. Old Business

R/A a. Review of Action Items from Previous Board Meeting: i. Dr. Stafford’s Buprenorphine Study ii. Updates to Section 25 of the DUR Manual iii. Review of HCV medication utilization (November 2017) iv. Prospective DUR review – Additive Toxicity (AT) v. Updated utilization data – CNS Depressants

Pauline Chan, RPh, MBA

940-950

4. New Business

R/A/D a. Board Activities i. Review of Board Goals and Objectives

Robert Mowers, PharmD

950-1000

R/A/D b. Pharmacy Update i. Opioid Quantity Limits ii. Psychotropic Drug Age Restrictions iii. DUR Program Review 2016 iv. Medicaid DUR State Comparison for FFY 2015 v. DUR and Medi-Cal Managed Care Final Rule vi. Quality Strategy 2016 Updates (NQF, CMS, DHCS) vii. 2017 Medicaid Core Measures (Child & Adult) viii. Expanding Pharmacy Practice ix. ADC Affinity Workgroup x. Psychotropic Medications Workgroup xi. Academic Detailing Webpage & Resources xii. HIV Surveillance, Prevention & Care Plan xiii. Improving Access to Pre-natal Vitamins

Pauline Chan, RPh, MBA 1000-1115

R/A/D c. Quarterly Report: 4Q2016 (October – December 2016) d. Review of Physician Administered Drugs: 3Q2016 (July –

September 2016) e. Prospective DUR

i. Review of DUR Alerts for New GCNs: 4Q2016 ii. Review of Prospective DUR Criteria: Additive Toxicity

(AT) Alerts f. Review of DUR Educational Outreach to Providers

i. Update: Buprenorphine ii. Update: Metabolic Monitoring 2016 iii. Update: Asthma 2017

Amanda Fingado, MPH 1115- 1200

R/A/D g. Retrospective DUR i. Review of Retrospective DUR Criteria: Proton-Pump

Inhibitors h. Review of DUR Publications

i. DUR Educational Bulletin (February, 2017): Fluoroquinolones

ii. Discussion/Recommendations for Future Educational Bulletins

Shalini Lynch, PharmD

1200-1225

C 5. Public Comments 1225-1230

I 6. Consent Agenda

a. Meeting feedback b. Next meeting: May 16, 2017

9:30 AM -12:30 PM DHCS Training Rooms A+B 1500 Capitol Avenue Sacramento, CA 95814

c. Future DUR Board Meeting Dates: Tuesday, September 19, 2017 Tuesday, November 21, 2017 Tuesday, February 20, 2018

7. Adjournment 1230

* REPORT TYPE LEGEND: A: Action; R: Report; I: Information; C: Comment; D: Discussion ** Comments from the public are always appreciated. However, comments will be limited to five minutes per individual.

Picture identification is required to gain access into the California Department of Health Services building. However, your security information will not be provided to the DUR Board.

You can obtain the DUR Board agenda from the Medi-Cal DUR Main Menu Web site (http://files.medi-cal.ca.gov/pubsdoco/dur/dur_home.asp).

http://files.medi-cal.ca.gov/pubsdoco/dur/dur_home.asp

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MEDI-CAL DRUG USE REVIEW BOARD MEETING MINUTES

Tuesday, November 15, 2016 9:30 a.m. – 12:30 p.m.

Location: Department of Health Care Services (DHCS) 1500 Capitol Avenue Training Rooms B + C Sacramento, CA 95814

Topic Discussion

1) CALL TO ORDER/ WELCOME/ INTRODUCTION

The meeting was called to order by the Vice Chair of the Board, Dr. Patrick Finley.

Board members present: Drs. Randall Stafford, Patrick Finley, Timothy Albertson, Janeen McBride, and Marilyn Stebbins.

Board members absent: Drs. Robert Mowers and Andrew Wong.

Board members and attendees introduced themselves.

Pauline Chan, RPh and Dorothy Uzoh, PharmD were present from DHCS Pharmacy Benefits Division.

Ms. Chan introduced Hannah Sandy, PharmD, the new DUR pharmacist from Xerox. Ms. Chan also introduced two other members of the DUR team: Thurman Frierson from the California Medicaid Management Information System (CA-MMIS) Division at DHCS and Dr. Rajiv Chopra, the Medical Director for Xerox State Healthcare, LLC.

2) REVIEW AND APPROVAL OF SEPTEMBER 2016 MINUTES

The Medi-Cal Drug Use Review Board (the “Board”) reviewed the September 20, 2016 minutes. There was no discussion. The Board voted unanimously to approve the minutes. ACTION ITEM: Post the September 20, 2016 minutes to the DUR website.

3) OLD BUSINESS

a. Review of Action Items from Previous Board Meeting: i. Opioid Quantity Limit Policy – Ms. Chan stated that a review of the existing opioid

quantity limit policy is underway. ii. State Opioid Workgroup – Ms. Chan reported that Dr. Stafford volunteered to represent

the DUR Board as a member of the state opioid workgroup. His application has been submitted and his appointment is currently under review.

iii. FFY 2015 DUR Annual Report to CMS – Ms. Chan reported the annual report was submitted to the Centers for Medicare & Medicaid Services (CMS) on September 21, 2016.

iv. Educational Outreach: Asthma – Amanda Fingado, MPH (UCSF) reported that the asthma mailing would be the first provider mailing for 2017, and letters would be mailed out most likely in mid-January of 2017.

v. Educational Outreach: Buprenorphine – Ms. Fingado reported that the buprenorphine mailing was recently completed, with more information to be provided later in the meeting.

vi. Educational Outreach: Metabolic Monitoring – Ms. Fingado reported that the second metabolic monitoring mailing was recently completed, with more information to be provided later in the meeting.

vii. Retrospective DUR Review: Proton-pump Inhibitors – Ms. Fingado reported that this review is in-progress and will be presented at the February 20, 2017 Board meeting.

4) NEW BUSINESS

a. Board Activities: Ms. Chan thanked Drs. Andrew Wong and Randall Stafford for their assistance with the Academic Detailing conference, which was held in Sacramento on October 20, 2016.

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i. Buprenorphine Prescribing Initiative – Dr. Stafford presented an outline of a proposed research project aimed at increasing the appropriate prescribing of buprenorphine in the Medi-Cal population. He reported that while there is increasing evidence that buprenorphine is a safer opioid, widespread adoption to its use is impacted by several barriers, including the following:

Stigma associated with maintenance

Invalid distinction between addiction and chronic use for pain

Legal restrictions on prescribing for maintenance

Waiver required for prescribing, which involves a lengthy 8-hour training

Limited number of local prescribers

Off-label use for pain is not well accepted

Dr. Stafford stated that the goals of the project would be to better understand current patterns of opioid prescribing, understand patterns of buprenorphine use, gauge provider reaction to potential policies, evaluate potential policies, conduct clinical trial/demonstration, and increase appropriate buprenorphine use. The study population would include both FFS and Medi-Cal managed care beneficiaries, and would include a survey of prescribers and an analysis of potential policies. For the clinical trial/demonstration, Dr. Stafford proposed a 2x2 randomized design that would include both a provider-oriented intervention and a consumer-oriented intervention. Primary outcomes would be the adoption of buprenorphine treatment in high-risk patients. Dr. Stafford reported that this project would be led by him through an academic/government partnership between Stanford University and DHCS, with opportunities for the DUR Board to add their expertise to project and assist with a formal endorsement of the project to assist with data use agreements and a request for data analytic support from DHCS. Dr. Stafford is currently seeking funding to help support the project. Dr. Albertson asked if Dr. Stafford had considered propensity matching to balance among provider specialties. Dr. Stafford stated they were considering matching by specialty, volume of opioid prescribing, and other practice variables. Dr. Albertson suggested that secondary outcomes could include a decrease in opioid prescribing or other unsafe prescribing like concomitant prescribing of sedatives and opioids.

A motion was made – and seconded – to endorse Dr. Stafford’s buprenorphine study. There was no further discussion. The motion was carried.

ACTION ITEM: The DUR Board recommendation to support DUR Board involvement in Dr. Stafford’s buprenorphine study will be submitted to DHCS.

b. Quarterly Report – 3Q2016 (July – September 2016): Ms. Fingado reported that a

comparison of 2016 Q3 to both the prior quarter and the prior-year quarter showed an across-the-board decrease in total utilizing beneficiaries and total paid claims. She stated that the greatest decrease in utilizing beneficiaries in comparison to both the prior quarter and the prior-year quarter was in the 12 years and under age group, which posted a decrease of 11% from the prior quarter and a decrease of 15% from the prior-year quarter. Ms. Fingado also provided the annual utilization summary of drugs by sourcing status that will be included in the annual report, including the top 10 drugs in each source code category, by total utilizing beneficiaries. She reported total paid claims were down across all three categories, primarily due to migration of utilizing beneficiaries out of the Medi-Cal Fee-for-Service (FFS) program and loss of patent exclusivity among some of the carved-out drugs. Ms. Fingado reminded everyone that source status is determined through National Drug Code (NDC) and that CMS provides the source file (updated quarterly). Among each of the three source categories, the top 10 drugs by total utilizing beneficiaries in Federal fiscal year 2016 (FFY 2016) were almost identical to the previous year (FFY 2015).

c. Review of Physician Administered Drugs (PADs) – 2Q2016 (April – June): Ms. Fingado

showed a summary of paid claims for physician-administered drugs for the 2nd

quarter of

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2016, which includes paid claims with dates of services between April 1, 2016, and June 30, 2016. These data were presented in three tables: 1) the top 20 drugs by total reimbursement paid, 2) the top 20 drugs by utilizing beneficiaries, and 3) the top 20 drugs by reimbursement paid to pharmacies per utilizing beneficiary. Ms. Fingado reported across-the-board decreases in both total utilizing beneficiaries and total paid claims from 1Q2016 to 2Q2016 and from 2Q2015 to 2Q2016. Ms. Fingado stated that these decreases are most likely due to continued migration of Medi-Cal beneficiaries from the fee-for-service program into managed care health plans.

Dr. Stafford questioned whether it was possible to review the temporal relationship between treatment with high-cost drugs such as blood factors and date of death. Dr. Albertson suggested that because these data represent outpatient use by physicians this is most likely for routine use and not being used as a last-line therapy. Dr. Stafford agreed and did not wish to explore any further evaluation at this time.

d. Prospective DUR reports were presented by Amanda Fingado

i. Review of DUR Alerts for New GCNs in 3Q2016 (July – September 2016)

At each DUR Board meeting, a list of new GCN additions with prospective DUR alerts turned on other than ER and DD will be provided to the DUR Board for review. For this meeting, the DUR Board reviewed the alert profiles of the following 23 GCNs: o GCN #076280: FENTANYL/BUPIVACAINE/NS/PF – Drug Allergy (DA), Drug-

Disease (MC), Therapeutic Duplication (TD), Additive Toxicity (AT), Ingredient Duplication (ID), High Dose (HD), Low Dose (LD)

o GCN #076310: DOXYCYCLINE/SKIN CLEANSER #19 – Drug-Pregnancy (PG) o GCN #076321: DOXYCYCLINE HYCLATE – Drug-Pregnancy (PG) o GCN #076244: MORPHINE SULFATE IN 0.9% NACL – Drug Allergy (DA),

Drug-Disease (MC), Therapeutic Duplication (TD), Additive Toxicity (AT), Ingredient Duplication (ID), High Dose (HD), Low Dose (LD)

o GCN #076334: FENTANYL CITRATE/PF – Drug Allergy (DA), Drug-Disease (MC), Therapeutic Duplication (TD), Additive Toxicity (AT), Ingredient Duplication (ID), High Dose (HD), Low Dose (LD)

o GCN #076329: METHOTREXATE/PF – Drug-Pregnancy (PG) o GCN #076353: EVOLOCUMAB – Drug-Pregnancy (PG) o GCN #076361: OXYCODONE HCL – Drug Allergy (DA), Drug-Disease (MC),

Therapeutic Duplication (TD), Additive Toxicity (AT), Ingredient Duplication (ID), High Dose (HD), Low Dose (LD)

o GCN #076092: CPM/PE/DM/ACETAMINOPHEN/GUAIFN – Ingredient Duplication (ID), High Dose (HD)

o GCN #076404: OMBITA/PARITAP/RITON/DASABUVIR – Ingredient Duplication (ID)

o GCN #076088: CIPROFLOXACIN HCL/FLUOCINOLONE – Drug-Disease (MC), Therapeutic Duplication (TD), Ingredient Duplication (ID), High Dose (HD), Low Dose (LD)

o GCN #076442: LISINOPRIL – Drug-Pregnancy (PG) o GCN #076254: NEBIVOLOL HCL/VALSARTAN – Drug-Pregnancy (PG) o GCN #076551: DICLOFENAC SODIUM/CAPSAICIN – Drug Allergy (DA), Drug-

Pregnancy (PG), Drug-Disease (MC), Therapeutic Duplication (TD), Ingredient Duplication (ID), High Dose (HD), Low Dose (LD)

o GCNs #076607 and #076608: ASPIRIN/OMEPRAZOLE – Drug-Pregnancy (PG), Therapeutic Duplication (TD), Ingredient Duplication (ID), High Dose (HD), Low Dose (LD)

o GCN #076262: NITROGLYCERIN – Therapeutic Duplication (TD), Ingredient Duplication (ID), High Dose (HD), Low Dose (LD)

o GCN #070910: NORETHINDRONE-E.ESTRADIOL-IRON – Drug-Pregnancy (PG), Drug-Disease (MC), Therapeutic Duplication (TD), Ingredient Duplication (ID), High Dose (HD), Low Dose (LD)

o GCN #076611: OXYTOCIN/0.9 % SODIUM CHLORIDE – Drug-Pregnancy (PG)

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o GCNs #076620, #076621, #076622, and #076623: CANAGLIFLOZIN/METFORMIN HCL – Drug-Disease (MC), Therapeutic Duplication (TD), High Dose (HD), Low Dose (LD)

A motion was made – and seconded – to accept these alert profile recommendations. There was no discussion. The motion was carried.

ii. Section 25 Update – Therapeutic Categories

The Therapeutic Duplication (TD) alert is generated when a patient receives two or more drugs from the same therapeutic or pharmacologic class, such that the combined daily dose increases the risk of an adverse medical result or incurs additional program costs without additional therapeutic benefit. At the DUR Board meeting in February 2015, the DUR Board motioned to have the reference material for the TD alert listed in Section 25 (DUR Appendix A: Duplicate Therapy) reviewed on an annual basis.

Ms. Fingado reported that Section 25 of the DUR Manual is in need of revisions due to the addition of new target drugs and modifications to drug therapeutic categories. The following changes were recommended to the DUR Board: o The addition of the following drug therapeutic category: ANTINEOPLASTICS

along with the deletion of STEROID ANTINEOPLASTICS as a separate drug therapeutic category

o The addition of the following drug therapeutic categories (under ANTIHYPERLIPIDEMICS): APO B SYNTHESIS INHIBITORS, PCSK-9 INHIBITORS, MTP INHIBITORS

o The addition of GRISEOFULVIN to ANTIFUNGALS and DIFLUNISAL to NON-STEROIDAL ANTI-INFLAMMATORY DRUGS

o Minor formatting updates to combine subcategories

A motion was made – and seconded – to accept the recommended edits to Section 25 of the DUR Manual. There was no discussion. The motion was carried.

ACTION ITEM: The DUR Board recommendations to update Section 25 of the DUR Manual will be submitted to DHCS.

e. Review of DUR Educational Outreach to Providers

i. Update: Metabolic Monitoring Letter - 2016

At the September 20, 2016 DUR Board meeting, the DUR Board recommended educational outreach to providers regarding metabolic monitoring for children and adolescents using antipsychotic medications, using methods similar to the mailing conducted in August 2015. Ms. Fingado described that for this mailing, eligibility criteria was re-reviewed for the 2,272 children and adolescents identified in the policy impact report who were in need of metabolic testing. The final study population for the mailing included a total of 361 prescribers identified for educational outreach letters, representing 578 beneficiaries. Prescribers were mailed a letter with a summary of clinical recommendations, a list of patients (name and date of birth) from the study population linked to this prescriber, the Medi-Cal DUR article on appropriate antipsychotic medication use among children and adolescents, and one response survey per patient.

Ms. Fingado reported that approval was received from DHCS to use National Provider Identifier (NPI) mailing addresses for all providers not listed in the Medi-Cal Provider Master File. All 361 prescriber letters were mailed on November 11, 2016. Ms. Fingado plans to report the 90-day undeliverable rate and the 90-day response rate at the next DUR Board meeting in February.

ii. Update: Buprenorphine Letter

At the September 20, 2016 DUR Board meeting, the DUR Board recommended educational outreach to providers regarding the use of buprenorphine. Ms. Fingado reported that a total of 100 top prescribers of opioids (by volume) without a current

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buprenorphine waiver were sent a letter with more information about buprenorphine training. In addition, a total of 100 top prescribers (by total number of patients) of buprenorphine in the Medi-Cal program were sent a letter thanking them for obtaining the waiver and letting them know that the maximum number of patients that qualified providers can treat has been raised to 275. Each mailing also included the Medi-Cal DUR article on buprenorphine and a provider response survey.

Ms. Fingado reported that approval was received from DHCS to use National Provider Identifier (NPI) mailing addresses for all providers not listed in the Medi-Cal Provider Master File. All 200 prescriber letters were mailed on November 11, 2016. Ms. Fingado plans to report the 90-day undeliverable rate and the 90-day response rate at the next DUR Board meeting in February.

f. Retrospective DUR presented by Shalini Lynch, PharmD (UCSF):

i. Review of Retrospective DUR Criteria: Hepatitis C Virus (HCV) Drugs

Dr. Lynch provided a brief background about regarding chronic hepatitis C virus (HCV) infection, a liver disease that results from infection with the hepatitis C virus. She described current treatment options for hepatitis C virus (HCV) infection, which have been evolving continuously since the first introduction of highly effective HCV protease inhibitor therapies in 2011. Within the Medi-Cal fee-for-service population, Dr. Lynch reported that these drugs are covered with an approved Treatment Authorization Request (TAR). Dr. Lynch also reported that in July 2015, the Department of Health Care Services revised its treatment policy for the management of chronic hepatitis C, expanding eligibility to beneficiaries with hepatitis C and light liver scarring and leading to an increase in approved TARs for HCV medications.

Dr. Lynch mentioned the ongoing discussion and debate regarding the high cost of treating chronic hepatitis C with the newer protease inhibitors. On average, she reported that a 12-week course of treatment may range from $54,000 to $94,500. Dr. Lynch reviewed Medi-Cal FFS pharmacy and medical claims data that show current use of these drugs follows updated clinical guidelines. The DUR Board agreed, and asked to revisit utilization data for these drugs the following year, especially to review any potential HCV retreatment in the Medi-Cal fee-for-service population.

A motion was made – and seconded – to accept the recommendation for an annual retrospective DUR review on HCV medication utilization. The next report will be scheduled for the DUR Board meeting in November 2017. There was no additional discussion. The motion was carried.

ACTION ITEM: The DUR Board recommendation to review utilization of HCV medications on an annual basis will be submitted to DHCS.

ii. Review of Retrospective DUR Criteria: New Additions to the Medi-Cal List of Contract Drugs (FFY 2015)

Dr. Lynch reported that each month there are usually modifications made to the Medi-Cal List of Contract Drugs, including the addition of new drugs. A review of utilization patterns for these drugs is conducted each year in order to determine if there is a need for further evaluation of any of the drugs added to the Medi-Cal List of Contract Drugs during the 2015 Federal Fiscal Year. Dr. Lynch stated that during the Federal Fiscal Year 2015 (between 10/1/14 and 9/30/15), there were a total of 22 new prescription medications added to the Medi-Cal List of Contract Drugs. Utilization data (total number of paid claims and utilizing beneficiaries with at least one paid claim) were reviewed for each of these drugs during the period between 10/1/13 and 08/31/16 to allow at least 11 months of utilization data before and after the drug was added to the Medi-Cal List of Contract Drugs. Twelve of the drugs had low utilization (< 10 utilizing beneficiaries during all of the months reviewed) and were not reported in detail. There were no comments or suggestions for additional evaluation.

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iii. Review of Retrospective DUR Criteria: Concomitant use of Opioids and Benzodiazepines

Dr. Lynch reported that on August 31, 2016, the U.S. Food and Drug Administration (FDA) announced that it will require class-wide changes to drug labeling, including patient information, to help inform health care providers and patients of the serious risks associated with the use of certain opioid medications in combination with benzodiazepines and other central nervous system (CNS) depressants. The FDA will now require boxed warnings and patient-focused Medication Guides for prescription opioids, opioid-containing cough products, benzodiazepines, and other CNS depressants in order to help inform patients about the serious risks associated with concomitant use. To address these updated warnings, First Databank (FDB) is adding several Severity Level 2 and 3 drug-drug interactions for these drugs. However, Dr. Lynch stated that the current Medi-Cal prospective DUR system only has Severity Level 1 drug-drug interactions turned on for the drug-drug interaction (DD) alert. The addition of these drug-drug interactions to Severity Levels 2 and 3 will mean that the proposed changes to the drug-drug interactions cannot be captured in the current system.

Ms. Fingado reported that there is another way to address these interactions through the use of the Additive Toxicity (AT) alert, which would send an alert after the fourth prescription of selected medications. She asked the DUR Board that if this was something they would consider, she could prepare a prospective DUR review on the AT alert and include utilization data for the concomitant use of multiple CNS depressants, in order to evaluate potential alert burden.

ACTION ITEM: The DUR Board recommendation to conduct a prospective DUR review on the potential use of the Additive Toxicity (AT) alert to capture high-risk prescribing of multiple CNS depressants will be submitted to DHCS. ACTION ITEM: The DUR Board recommendation to summarize utilization data regarding high-risk prescribing of multiple CNS depressants will be submitted to DHCS. g. Review of DUR Publications presented by Dr. Lynch

i. Dr. Lynch summarized the DUR educational alert, “2016 Immunization Updates: Influenza, Meningococcal, Tdap, Hib,Rotavirus,” which was published in September 2016 in collaboration with the Immunization Branch. Dr. Lynch reviewed the new federal Advisory Committee on Immunization Practices (ACIP) recommendations for the 2016-2017 influenza season, including that ACIP no longer recommends using live attenuated influenza vaccine (the “nasal spray” flu vaccine). Dr. Lynch also reported on a current meningococcal serogroup C outbreak occurring in Southern California, primarily among adult men who have sex with men (MSM). She stated that since March 2016, at least 24 confirmed cases, including two fatal cases, have been reported among residents of Los Angeles and Orange counties. Updates to treatment guidelines for Haemophilus b (Hib) and rotavirus were also discussed, as well as the most recent pertussis data available in California.

ii. Discussion/Recommendations for Future Educational Bulletins

The calendar for future DUR educational bulletins was reviewed. Ms. Chan suggested using immunization utilization data to accompany future immunization updates. Dr. Stebbins suggested a retrospective DUR review of hormonal contraceptives, in light of new California regulations allowing dispensing of these products by pharmacists. She also suggested a review of the most recent report on antibiotic use published by the CDC within the last week. There was no further discussion.

h. Global Data Sharing and Public Reporting of Psychotropic Medication Use in Foster Care Children & Youth – Dr. Akhtar Khan was unable to make the meeting so Ms. Chan presented a few highlights from his presentation, including the following website for the California Child Welfare Indicators Project: http://cssr.berkeley.edu/UCB_CHILDWELFARE/. Ms. Chan presented handouts that contained preliminary data looking at the use of psychotropic medications and antipsychotic

http://cssr.berkeley.edu/UCB_CHILDWELFARE/

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medications among children in foster care. Ms. Chan wanted to make sure the DUR Board knew about this website and stated that it could be a resource for future DUR projects.

i. Overview of the Institute for Clinical and Economic Review (ICER) – Dr. Steven Pearson, the Founder and President of the Institute for Clinical and Economic Review (ICER) called in and presented an overview of ICER for the DUR Board. ICER is an independent non-profit organization that evaluates the evidence on the value of medical tests, treatments, and delivery system innovations to encourage collaborative efforts to improve patient care and control costs. They provide timely and publicly-available evidence reports and convene independent appraisal committees for public meetings, evidence votes, and policy recommendations. Dr. Pearson described the bulk of the funding for ICER comes from non-profit organizations, with industry allowed to contribute towards the ICER Policy Summit only. He then briefly described the value assessment framework used by ICER and provided some examples of ICER reports and value-based pricing. Dr. Pearson looks forward to collaborating with the DUR Board in the future and would welcome the opportunity to speak with the DUR Board in person someday. There were no further questions for Dr. Pearson, although he did provide a brief introduction to the next speaker, Dr. Drhuv Kazi. Dr. Kazi provided a quick overview of his upcoming presentation to the DHCS Learning Series. He reviewed PCSK-9 inhibitors in order to present a framework of how ICER assesses the value of high-priced specialty pharmaceuticals. Dr. Kazi stated that he hoped to lay the foundation for potential future collaborations between DHCS and the Center for Vulnerable Populations at UCSF.

j. Pharmacy Update i. CMS Update

Antipsychotic Drug Use in Children (ADC) Affinity Group – Ms. Chan briefly updated the recent work of the ADC Affinity Group and the project assignments submitted thus far.

Prescription Opioids Abuse Actions – Ms. Chan presented information from the September 29, 2016 CMS teleconference on the topic “Medicaid State Agencies Pharmacy Programs’ Latest Strategies to Combat the Opioids Epidemic.” Ms. Chan reported on efforts by Georgia, Maryland, Michigan, and Wyoming to combat prescription opioid abuse.

2018 CMS DUR Annual Report Planning Committee – Ms. Chan reported that effective FFY 2018, managed care health plans will be included in the DUR annual report. Ms. Chan stated that CMS has rescheduled their planned call for November 10

th to sometime in 2017.

ii. Academic Detailing Conference – Ms. Chan discussed the October 20, 2016 Academic Detailing conference that was held at DHCS in Sacramento. She provided handouts summarizing very positive feedback from the conference attendees. There were a total of 14 participating organizations and six supporting organizations. The next steps include collation of academic detailing resources and the potential for future collaborations with the National Resource Center for Academic Detailing (NARCAD).

iii. DHCS Quality Strategy annual update – Ms. Chan reported that this year there is a new web-based QI Evaluation System for the annual survey, in which new questions have been added to address health disparities. Ms. Chan stated that this will allow easier and more efficient updates to existing QI projects and addition of new QI projects. Ms. Chan also reported that there are opportunities to include DUR studies in the DHCS Quality Strategy.

iv. SB 238: Foster Care Psychotropic Medication – Ms. Chan reported on this law that was signed into law by Governor Brown in October 2015. It requires certification and training programs for care givers to include psychotropic medication, trauma and behavioral health. To assist with implementation, CDSS and DHCS established the SB 238 Psychotropic Medication Implementation (PMI) Workgroup to develop county-specific monthly reports that will include psychotropic medication data, including up-to-date court authorizations, pharmacy data, the use of psychosocial interventions, and will include indicators that identify each child under five years of age for whom one or more psychotropic medications is prescribed and each child of any age for whom three or more psychotropic medications are prescribed.

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v. Foster Care Psychotropic Medication Quality Improvement Project (QIP) – Ms. Chan provided a brief summary of this QIP, which was initiated in July 2012 by DHCS and CDSS and was made up of the following three workgroups:

Clinical

Data & Technology

Youth and Family Education Ms. Chan reported that all workgroups have now been merged to the SB 238 Psychotropic Medication Implementation workgroup and will continue tracking and trending of improvements and outcomes.

iv. Improving Access to Prenatal Vitamin Use– Ms. Chan reported that there are currently opportunities for the DUR Board to collaborate with California Department of Public Health (CDPH) through outreach programs, including a program to improve access to pre-natal vitamin use.

5) PUBLIC COMMENTS

None

6) CONSENT AGENDA

The next Board meeting will be held from 9:30 a.m. to 12:30 p.m. on February 21, 2017 in the Mendocino room at Conduent, 840 Stillwater Road, West Sacramento, CA 95605.

7) ADJOURNMENT The meeting was adjourned at 12:28 p.m.

Action Items Ownership

Post the September 20, 2016 minutes to the DUR website. Amanda

The DUR Board recommendation to support DUR Board involvement in Dr. Stafford’s buprenorphine study will be submitted to DHCS.

Pauline

The DUR Board recommendations to update Section 25 of the DUR Manual will be submitted to DHCS.

Amanda

The DUR Board recommendation to review utilization of HCV medications on an annual basis will be submitted to DHCS.

Amanda

The DUR Board recommendation to conduct a prospective DUR review on the potential use of the Additive Toxicity (AT) alert to capture high-risk prescribing of multiple CNS depressants will be submitted to DHCS.

Hannah/Amanda

The DUR Board recommendation to summarize utilization data regarding high-risk prescribing of multiple CNS depressants will be submitted to DHCS.

Amanda

Implement the DUR requirements of Medicaid and CHIP Managed Care Final Rule (CMS-2390-F)

Revise the DUR Bylaws

02/21/2017 Medi-Cal DUR Board Meeting Pharmacy Update 1

DUR Board Goals 2017-2018 (1)

Promote dialogue, collaboration and recommend best practices in pharmacy utilization management on drugs that are commonly used in both Medi-Cal Fee-For-Service (FFS) and Managed Care Organizations (MCOs).



Establish a Plan to systematically review prospective DUR alerts

Establish a Plan to systematically develop retroactive DUR criteria

Conduct studies to evaluate various methods in the design of “dear doctor” letters



Conduct learning collaborative with MCOs and other agencies to promote best practices using academic detailing (AD).

Align DUR board goals with DHCS Quality Strategy

o Include one DUR measure in the DHCS quality report



Medi-Cal Drug Utilization Review

Board Meeting

Pharmacy Updates

Pauline Chan, R.Ph., MBA

Pharmacy Policy Branch

2-21-2017

Topics

• Opioid Quantity Limits

• Pharmacy Policy: Psychotropic Drugs Age Restrictions Effective

1/1/2017

• DUR Program Review 2016

• Medicaid DUR State Comparison for FFY 2015

• CMS: Medicaid and CHIP Managed Care Final Rule (CMS 2390-F)

• Quality Strategy 2016 updates (NQF, CMS, DHCS)

• CMS Information Bulletin (IB): 2017 Adult Core Set and Child Core

Set Measures – added measures

• CMS IB: Expanding the Scope of Pharmacy Practice

Medi-Cal DUR Board Meeting 02-21-17

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Topics (cont.)

• CMS Antipsychotic Drugs in Children Affinity Group

– Newsletters, work in progress

• Psychotropic Medications Quality Improvement Project

– Workgroups

– Data sharing, measures and indicators

• Academic Detailing Webpage & Resources

• California’s Integrated HIV Surveillance, Prevention & Care Plan

• Opportunities to improve access to pre-natal vitamin use

Medi-Cal DUR Board Meeting 02-21-17 3

Opioid Quantity Limits (1)

Medicaid DUR state comparison report 2015:

• Opioid quantity limit for short-acting opioids

– 35 states have set quantity limits

– Limits vary by state

• Set number of units/day (14 states)

• Varying number of units/day by individual drug (21 states)

• Set number of days supply (31 states)

• CA quantity limits somewhat unique

– 15 states have not set quantity limits


4

Opioid Quantity Limits (2)

Medicaid DUR state comparison report 2015 (continued):

• Opioid quantity limit for long-acting opioids

– 39 states have set quantity limits

– Limits vary by state

• Set number of units (most either 2 or 3 units/day)

• Set number of days supply at 30 days (21 states)

• Varying number of days supply by individual drugs (17

states)

• CA is somewhat unique

– 11 states have not set quantity limits


5

Opioids Quantity Limits (3)

Best practice from health plans:

• Setting opioids quantity limits is part of a comprehensive plan to curb opioid

epidemic

• Case studies from three health plans

• Smart Care California (January 2017) Check list

– Four priorities areas: Provider Network, Medical Benefit, pharmacy

benefit and Member Services

– Pharmacy benefits interventions includes quantity limits

• California Health Care Foundation (June 2016) Changing course

– Most successful efforts use multifaceted approach

– Action in isolation may be ineffective


http://www.chcf.org/~/media/MEDIA LIBRARY Files/PDF/PDF C/PDF CaseStudiesHealthPlansOpioid.pdf

http://www.chcf.org/~/media/MEDIA LIBRARY Files/PDF/PDF H/PDF HealthPlansOpioidChecklist.pdf

http://www.chcf.org/~/media/MEDIA LIBRARY Files/PDF/PDF H/PDF HealthPlansOpioidChecklist.pdf

http://www.chcf.org/publications/2016/06/changing-health-plans-opioid

Psychotropic Drugs Age Restrictions

• Effective 1/1/2017, age restrictions have been added to

all psychotropic drugs, based on the FDA-approved

minimum age for each drug

• This addition is based on recommendations from the

state auditor’s report State 2015-131 on California’s

foster care system


https://www.auditor.ca.gov/pdfs/reports/2015-131.pdf




Psychotropic Drugs Age Restrictions (cont.)

• If the beneficiary does not meet the FDA-approved

minimum age, an approved Treatment Authorization

Request (TAR) will be needed in order to complete the

transaction

• Medi-Cal DUR to monitor the impact of this new

restriction


DUR Program Review 2016

• Dr. Robert Mowers began two-year term as DUR board chair

• Dr. Patrick Finley began two-year term as DUR vice-chair

• Dr. Marilyn Stebbins co-authored a white paper on Comprehensive Medication

Management (CMM), sponsored by the California Department of Public Health

• Initiated a new project: Academic Detailing, “kick off” conference in October

• Endorsed a new Buprenorphine Study led by Dr. Randall Stafford

• Dr. Hannah Sandy joined as new DUR pharmacist from Conduent (formerly Xerox)

• Published six educational articles

• Mailed a total of 825 provider letters on five educational DUR topics

• Continued outreach with board representation at state-wide opioid workgroup and

Psychotropic Quality Improvement Project (QIP)

• DUR team represented California Medi-Cal in CMS Antipsychotic Drugs for Children

(ADC) Affinity Workgroup

• DUR team presented a poster at the American Drug Utilization Review Society

(ADURS) annual meeting


Medicaid DUR State Comparison for FFY 2015

• State comparison report 2015

• Highlights from the Medicaid Drug Utilization Review State

Comparison/Summary FFY 2015 Annual Report

– How California compares with the rest of the country’s state Medicaid agencies

– What we learned

– What we could improve

– Limitations

– Opportunities


https://www.medicaid.gov/medicaid-chip-program-information/by-topics/prescription-drugs/downloads/2015-dur-summary-report.pdf



CMS: Medicaid and CHIP Managed Care Final Rule

• CMS: Medicaid and CHIP Managed Care Final Rule (CMS 2390-F)

• Refer to slide set from CMS

• Key dates:

– Publication of Final Rule

• On display at the Federal Register on April 25th 2016

• Published in the Federal Register on May 6th, 2016 (81 FR 27498)

– Dates of Importance

• Effective date is July 5th, 2016

• Provisions with implementation date as of July 5th, 2016

• Phased implementation of new provisions primarily over 3 years,

starting with the rating period for contracts starting on or after

July 1, 2017


Quality Strategy

• Aligning DUR to quality strategy of:

– National Quality Forum (NQF)

• National Strategy for Quality Improvement in Health Care

– Centers for Medicare & Medicaid Services (CMS)

– Department of Health Care Services (DHCS)


Quality Strategy (cont.)

NQF Three Aims

1. Better Care

2. Healthy People & Communities

3. Affordable Care

Six Priorities

1.Safer care 2. engaged persons and families 3. care coordination 4. prevention 5. healthy living communities 6.

spread affordable care delivery models

CMS Three Aims

1. Better Care

2. Healthy People & Communities

3. Smarter Spending

Five Goals

1. Safer care 2. engaged persons and families 3. care coordination 4. prevention 5. healthy living communities

DHCS Three linked Goals

1. Enhance quality, including patient care experience

2. Improve health

3. Reduce per capita health care program cost

Seven Priorities

1. Safer care 2. deliver effective, efficient and affordable care 3.

engaged persons and families 4. care coordination 5. prevention

6. health communities 7 eliminate disparities


DHCS Quality Strategy Report

• Released annually

• Includes progress and status of

QIPs

• Organized by the 7 priorities

• Organized by divisions and

programs

• DUR to submit a project for

continuous tracking and

trending


2017 Adult & Core Set Measures (1)

On December 5, 2016 CMS announced new 2017 core measures in

an Informational Bulletin (IB):

• Core sets are tools states can use to monitor and improve the quality of

health care provided to Medicaid and CHIP enrollees

• Under statue, state reporting on these measure sets is voluntary

• Since the core sets were established in 2010 and 2012, states have made

progress reporting on the core measures



• For FFY 2015, all states and the District of Columbia (DC) reported

at least one Child Core Set measure, and 41 states voluntarily

reporting at least 12 of the 23 Child Core Set Measures. The median

number of measures reported was 16

• For FFY 2015, 39 states voluntarily reported adult core set

measures. The median number of measures reported was 16

• CMS works with National Quality Forum (NQF) Measure Application

Partnership (MAP) to continuously reassess and prioritize measures

• Core measure sets are updated annually and reporting cycle follows

federal fiscal year calendar



2017 Child Core Set: Two new measures

• Use of First-Line Psychosocial Care for Children and Adolescents

on Antipsychotics

• Contraceptive Care – Postpartum

2017 Adult Core Set: Three new measures

• Diabetes Care for People with Serious Mental Illness

• Follow-up after Discharge from the Emergency Department for

Mental health or Alcohol or Other Drug Dependence

• Contraceptive Care - Postpartum


Expanding Pharmacy Scope of Practice

• CMS IB: January 17, 2017

– Allowing pharmacists to dispense drugs prescribed

independently, or under collaborative practice agreements,

standing orders, or other predetermined protocols

– Specific examples:

• Naloxone

• Nicotine replacement therapy

• Immunization

• Emergency contraception

– CMS encourages states to consider using methods to promote

access particularly to those drugs that can help address

priority public health issues


CMS Antipsychotic Drugs in Children (ADC)

Affinity Workgroup

• Timeline

– One year commitment, beginning March 2016

• Progress

– Driver diagram

– Implementing small change

– Tracking results

• Information

– Newsletters, reports

• Learning

– Collaborative learning among states

• Technical assistance/support

– Provided by CMS


19

1. Identify Overall Aim /Measure(s) to improve:

Managed

Care Plans

Drug

Utilization

Review Board

DHCS

• Measure HEDIS with

stratifications

• Measure underlying

utilization measures

• Monitor TARs

Measure and/or data

• Conduct DUR evaluation &

issue report of metabolic

monitoring

• HEDIS measures (APM, APP,

APC) and associated

numerators and denominators

State Affinity Group Participant

Levers of Influence

• Educate providers

• Provider feedback on performance

• Coordinate services available

• Medical and Pharmacy director feedback

• Ability to partner with other state and federal agencies

• Benefits and State Plan Requirements (eg. TARs)

• Contracting requirements

• Legislative/ regulatory levers

• Reporting processes

• Share intervention roadmaps (provider letters template,

education bulletins, literature references)

• Offer clinical expertise in psychiatry and primary care

• DUR board provides clinical guidance and conduct DUR

evaluation, recommend next steps

• Increase quality of care HEDIS

measures (APM, APP)

Goals

• Ensure lab monitoring is being

performed when antipsychotics

are prescribed

• Achieve HEDIS goals at the plan

level (APM, APP)

• Coordinate care across providers

Key Stakeholders

2. Who will

take action?

3. How can each

actor/stakeholder

contribute

4. How can you

assess/track how

each stakeholder is

doing?

5. What can the stakeholder do to

drive towards the goals?

By December 2016, improve monitoring and services associated with antipsychotic medication use in Medi-Cal (managed care and FFS) Children and adolescents 0-17

years of age by: i) achieving metabolic monitoring on maintenance antipsychotic medications (HEDIS APM) to 60% and ii) achieving use of psychosocial services prior to

antipsychotic use (HEDIS APP) to 80%. The baseline year is 2014. Measuring period 2015 and 2016.

California Driver Diagram Page 1

Baseline rate (date): Calendar year 2014

APM: 30.8% (52.4% FC); APP 59.1% (78.5% FC); APC 5.5% (5.8% FC) Target rate (date): Calendar Year 2016, interim year 2015

APM: 60% (2016); APP 80% (2016);


20

California Driver Diagram Page 2

Specialty

Mental Health

• HEDIS measures (APM,

APP, APC) and associated

numerators and

denominators

Measure and/or data State Affinity Group Participant

Levers of Influence

• Provider and Clinic education and monitoring

• Achieve HEDIS goals at the

plan level (APM, APP)

• Coordinate care across

providers

Goals Key Stakeholders

2. Who will

take action?

3. How can each

actor/stakeholder

contribute

4. How can you

assess/track how

each stakeholder is

doing?

5. What can the stakeholder do to

drive towards the goals?


Improving Psychotropic Medication for Children & Youth

Quality Improvement Project (QIP) - 1

• Background

– Medi-Cal pharmacy policies, 2006, 2011, 2014, 2017

– 16-State Study, 2008

– Federal Legislation, 2012

– Quality Improvement Project, 2012

– CA State legislation, 2015 & 2016

– CA State Auditor report, 2016




• Clinical, Data and Technology, Youth & Family Education

Workgroups have completed deliverables in 2016

• QIP transitions to Implementation Workgroup:

– Annual revision of California guidelines

– Ongoing data sharing (DHCS, CDSS, counties)

– Ongoing data collection and analyses with quarterly posting on

public website

• Expert Panel

– Continues to convene regularly




• Data Sharing

– Purpose

• Provide information to counties and tribes to effectively

monitor psychotropic medication use among children in foster

care

– Overview

• Matched data between child welfare services/case

management system (CWS/CMS) and Medi-Cal

• Counties or tribes receive matched data in 1 of 2 ways:

– Global Data Sharing Agreement, or

– Psychotropic Medication Data Sharing Agreement




– Data Sharing Overview (continued):

• Parties agree to exchange both confidential and non-

confidential data

1.Demographics

2.Case information

3.Medication

4.Prescriber

5.Pharmacy


25



– Global Data Sharing Agreement

• Available data includes

1.Demographics

2.Medical

3.Mental Health

4.Payment

5.Medication Data

– Psychotropic Medication Data Sharing Agreement

• Available data includes

1. Psychotropic medications


Psychotropic Medication Measures & Indicators

• Measures developed by Data Workgroup (5a-h)

• Reconciliation of court authorization and psychotropic

medication claims

• Senate Bill 238 Data Indicators

• Monthly SafeMeasures Report


Psychotropic Medication Measures

• 5a.1: Use of psychotropic medications

• 5a.2: Use of antipsychotic medications

• 5c: Multiple Concurrent use of antipsychotics

• 5d: Metabolic monitoring during use of antipsychotics

• 5e: Use of First-Line Psychosocial Care

• 5g: Follow-up visits for youth and children

• 5h: Metabolic baseline screening for antipsychotic new

starts


Use of Psychotropic & Antipsychotic Medications

(Measure 5a.1 & 5a.2)

Public Website

13.3% 13.6% 13.3% 13.3% 13.2% 12.7% 7.1% 7.2% 6.7% 6.0% 4.9% 4.4% 0%

2%

4%

6%

8%

10%

12%

14%

2011 2012 2013 2014 2015 2016Q2

Pe

rce

nt

Calendar Year

5a.1 - Use of Psychotropic Medication

5a.2 - Use of Antipsychotic Medication

29

http://cssr.berkeley.edu/ucb_childwelfare/CDSS_5A.aspx

http://cssr.berkeley.edu/ucb_childwelfare/CDSS_5A.aspx

Reconciliation of Court Authorization & Psychotropic

Medication Claims

• Reconciliation data comes from various sources:

– County

• Case ID

– Child Welfare Services/Case Management System

• Court records and authorization/consent dates

– Medi-Cal

• Pharmacy claims


SB 238 Reporting Requirements

• Monthly

• County-specific Measures

– Psychotropic Medications (5a.1)

– Antipsychotic Medications (5a.2)


SB 238 Reporting Requirements (cont.)

• Indicators

– Children five and under on at least one psychotropic medication

– Children of any age on 3+ psychotropic medications

• Indicators in development

– Two or more concurrent medications by class:

1. Antipsychotics 4. Antidepressants

2. Stimulants 5. Mood Stabilizers

3. Antianxiety

– Dosages exceeding recommended guidelines

– Off-label use

– Length of time on medications by class


Academic Detailing

• Resources:

– Academic Detailing

• Ongoing collaboration

– National Resource Center for Academic Detailing

(NaRCAD)

– Veteran’s Administration

– Academic institutions

– Medi-Cal Managed Care Health Plans


http://files.medi-cal.ca.gov/pubsdoco/dur/dur_wnup.asp

California’s Integrated HIV

Surveillance, Prevention & Care Plan

• California's HIV Plan

• Goals

• Objectives

• Strategies

– Specific pharmacy related strategies

– Role of the DUR


http://www.cdph.ca.gov/programs/aids/Pages/GettingtoZeroCalifornia.aspx

Improving Access to Pre-natal Vitamin Use

• There are approximately 500,000 Medi-Cal births throughout the

state each year

• Based on Medi-Cal pharmacy claims data, between July 1, 2015 to

June 30, 2016, the number of unique Medi-Cal beneficiaries on pre-

natal vitamins with folic acid:

– Fee-For-Service 98,302 beneficiaries

– Managed Care 122,779 beneficiaries

• Opportunities to improve access to pre-natal vitamin use

• Opportunities to collaborate with California Department of Public

Health (CDPH) through outreach programs



Questions?

Email:

[email protected]

36

DUR SURVEY COMPARISON REPORT 2015 SUMMARY

1

Highlights from the Medicaid Drug Utilization Review State

Comparison/Summary Report FFY 2015 Annual Report Prescription Fee-For-Service Program

December 2016

I. Demographics All states, including District of Columbia, submitted a 2015 Medicaid DUR annual report, except

Arizona because almost all of its beneficiaries have enrolled in Managed Care Organizations

(MCOs). This summary focuses primarily on fee-for-service DUR activities. States are not

currently required to submit an annual report on the specifics of MCO DUR activities.

II. Prospective DUR A. General

Forty-five states, including California, utilize a vendor to provide prospective DUR. Out of this

group, twenty-two states use the same vendor as the state’s MMIS fiscal agent, and twenty-

three states do not.

Twelve states, including California, contracts with Xerox. The vendor with the second highest

number of state contracts is Hewlett Packard Enterprise Services, with eleven states.

Only five states operate their own prospective DUR.

Forty states use First Data Bank and nine states use Medi-Span; one state, Delaware, uses

Micromedex.

For thirty-one states, the state’s DUR board approves the new prospective DUR criteria. For the

other nineteen states, the approach varies. For California, the Medi-Cal DUR board advices and

makes recommendation. The final decision is from DHCS.

Forty-four states, including California, allow the pharmacist to override the alert using the

“conflict, intervention and outcome” codes.

Fourteen states review reports providing individual pharmacy activity in summary and in detail

every month, twelve states review quarterly, six states, including California, review annually;

and eighteen states never review. The reasons for not review vary, some states do not have the

capability to review, and one state did not find this review valuable.

Fifteen states take follow up actions with individual pharmacy providers who routinely override

with interventions, including contacting the pharmacy or referring to program integrity. Other

methods include using academic detailing (Alabama), referring to office of inspector general

(Maryland), and referring to Program Policy Bureau Utilization Unit (New Mexico). Twenty

states, including California, do not take follow up actions.


2

B. Early Refills

All fifty states reported setting up controls on early refills on both non-controlled and controlled

drugs. The percentage threshold for non-controlled drugs is 70%-90% (average 79%) and for

controlled drugs is 70%-100% (average 84%).

When an early refill message occurs for non-controlled drugs, thirty-five states require prior

authorization; and either the pharmacist or the prescriber, or both, can request prior

authorization. Fifteen states, including California, do not require prior authorization, with

eleven states allowing pharmacist to override. Four states do not allow override.

When an early refill message occurs for controlled drugs, forty-one states require prior

authorization; and either the pharmacist or the prescriber, or both, can request prior

authorization. Nine states, including California, do not require authorization, with six states

allowing pharmacist to override. Three states do not.

Most states do not allow pharmacist to override early refills due to lost/stolen prescription or

vacation. California allows pharmacist to override both as long as the prescriptions are medically

necessary.

Seventeen states have accumulation edit in the system to prevent patients from continuously

filling prescription early. The edit system varies. Some allows for 7 days accumulation over a

120 day look-back period (Arkansas, Alabama), some has specific limitations on therapeutic class

-examples are PPI, skeletal muscle relaxants (Florida), refills too soon carryover days accumulate

from month to moth (Illinois). Thirty-three states, including California, do not have this edit. Out

of the thirty-three states, eleven states plan to implement this edit. Note: Alabama uses Hewlett

Packard, Arkansas and Florida use Magellan, and Illinois is state operated. The current California

system does not have this capability.

C. Auto-Refill

Nineteen states have their state or state board of pharmacy prohibiting auto refill. Thirty-one

states, including California, do not prohibit auto refill.

D. Top 10 Claims Data

Forty-five states’ DUR board, including California, reviewed the top 10 claims data. Five states

did not.

E. Patient Counseling

Section 1927(g) (A) of the Social Security Act requires that the pharmacist offer patient

counseling at the time of dispensing. Either the state’s Medicaid agency or the state’s board of

pharmacy monitors this requirement. Only three states differ: the Illinois Department of

Financial and Professional Regulation (IDFPR) licenses pharmacists and monitors, Missouri

Medicaid Audit and Compliance Unit monitors, and New York Office of Professional Discipline

pays on-site inspections.

Forty-three states, including California, submitted a monitoring report as Attachment I. Seven

states did not.


3

III. Retrospective DUR Thirty-seven states used a vendor to perform retrospective DUR activities.

Eleven states used an academic institution to perform retrospective DUR activities.

Nebraska contracts with the Nebraska Pharmacists Association and Washington State Medicaid

performs its own retrospective DUR activities.

Eight states use the same retrospective DUR vendor as their Medicaid fiscal agent. Forty-two

states use a different vendor.

For forty-two states, the retrospective DUR vendor is also the developer/supplier of the state’s

DUR criteria.

For the rest of the eight states, the approach varies. Some state Medicaid agencies develop their

own criteria; others use a combination of academia and state Medicaid. For California, UCSF and

DHCS jointly develop the criteria, with input and recommendation by the Medi-Cal DUR board.

DHCS approves the criteria.

All fifty states submitted a retrospective DUR report as Attachment II.

IV. DUR Board Activities

A. General

All fifty states submitted a DUR activity report as Attachment III.

B. Disease Management

Seventeen states, including California, have a disease management program. Only five out of the

seventeen states had performed an analysis of the program’s effectiveness. For example, in

Indiana, the Managed Care Entities (MCEs) monitors and evaluates through MCEs quality

improvement processes at the individual health plan level. Massachusetts has educational

outreach interventions to prescribers. Maine was able to abate 1.5 million in inappropriate drug

therapy. The hemophilia management program in Utah results in better clinical and quality of

life outcomes. The Vermont Chronic Care Initiative (VCCI) demonstrates positive impact

especially among members with a history of depression.

In California, the DUR does not perform program effectiveness and board is not involved in this

program.

C. Medication Therapy Management

Six states have an approved CMS Medication Therapy Management (MTM) Program. Forty-four

states, including California, do not.

Only one state, Florida’s DUR performed an analysis of the MTM program’s effectiveness.

Qualitative findings support several benefits based on the members’ responses to open-ended

questions and survey items, including enhanced medication adherence and greater

understanding of their medications.

Two states, Missouri and Wisconsin reported DUR involvement in this program.

Sixteen states, including California, reported future planning to develop and implement a MTM

program.


4

V. Physician Administered Drugs (PAD) Eleven states have incorporated PAD data into prospective DUR criteria.

Thirty-nine states, including California, have not incorporated PAD data into prospective DUR

criteria. Out of this group, twenty states, including California, plan to include this information in

the future.

Twenty states, including California, have incorporated this data into retrospective DUR criteria.

Thirty states have not incorporate this data into retrospective DUR criteria.

VI. Generic Policy and Utilization Data All fifty states are including a description of generic drug use policies as Attachment 4.

In addition to the requirement that the prescriber write in his/her own handwriting “Brand

Medically Necessary” for a brand name drug to be dispensed in lieu of the generic equivalent,

forty-one states, including California, have more restrictive criteria.

States utilize a variety of approach to further restricting the use of brand name drugs, including

requiring submitting a MedWatch Form, documenting medical reasons for override generic, and

preauthorization. For California, if a brand name drug does not appear on the Medi-Cal List of

Contract Drugs, an approved Treatment Authorization Request may be required before

dispensing.

VI-3 listed each state’s generic utilization percentage for all covered outpatient drugs during this

period. CMS has standardized the computation of this data and all states are reporting using

the same specification. The generic utilization percentage for California is at 67%. Compared to

other states, this is low for many reasons: 1) California contracts with manufacturers for

multisource brand/generic name drugs and is able to contract with brand name manufacturers

at a lower cost than a generic; 2) many carved out drugs are single source/ brand name only.

Carved out drugs are included in the computation of this data.

VI-4 listed each state’s generic utilization percentage dollars paid for generic covered outpatient

drugs in relation to all outpatient covered drug claims paid. California is at 10%.

VII. Program Evaluation/Cost Savings/Cost Avoidance Forty-nine states, including California, conducted a DUR program evaluation of the estimated

cost savings/cost avoidance. Only four states conducted evaluation by an academic institution

(California, Massachusetts, Oklahoma and Wyoming).

States are encouraged to identify any cost savings related to the program, and to include

prospective DUR, retrospective DUR or both. California reported cost savings solely from the

Prospective DUR program. California’s grand total estimated avoided costs is $217,545,867.

On average, grand total of state’s cost savings is $91,570,678 per state.

The percent impact of cost savings/avoidance compared to total drug spend for California is at

6%

On average, percent impact is at 22%

CMS does not specify the standards for the cost savings computation, which explains why there

is wide variation of cost savings among the states.


5

Forty-nine states are providing the cost savings report as Attachment 5. Each state also explains

how they calculate savings.

VIII. Fraud, Waste, and Abuse Detection

A. Lock-In or Patient Review and Restrictive Programs

General

All fifty states reported there is a documented process in place that identifies fraud or abuse of

controlled drugs by beneficiaries.

Actions from state include: 1) deny claims and require preauthorization, 2) refer to lock-in

program, and 3) refer to program integrity unit, and others.

For California, 22 CCR 50793 specifies the utilization restrictions. The Audit and Investigation

Branch (IB) of DHCS is responsible for working beneficiary cases. IB has an intake process for

complaints. Subsequent actions are dependent upon the outcome of IB’s investigation.

Forty-eight states, including California, have a “lock-in” program for beneficiaries. Criteria to

identify candidates include the number of controlled substances, different prescribers, multiple

pharmacies, quantity (number of days of supply), exclusivity of short-acting opioids, multiple ER

visits, and others.

For California, identified beneficiaries are restricted to both prescriber and pharmacy access.

The lock-in period is 24 months (22 CCR 50793). The percentage of the FFS population in lock-in

status annually is <1%. California does not report estimate of the savings of this program.

Fraud or Abuse of Controlled Drugs by Prescribers

Forty states, including California, reported there is a documented process in place that identifies

possible fraud or abuse of controlled drugs by prescribers.

Actions taken includes deny claims by the prescriber, refer to program integrity unit, refer to

appropriate Medical Board and other actions. California is taking steps to propose new policy

such as quantity restrictions and further review by IB and Medical Review Board (MRB).

Fraud or Abuse of Controlled Drugs by Pharmacy Providers

Forty states, including California, reported there is a documented process in place that identifies

potential fraud or abuse of controlled drugs by pharmacy providers. California’s action includes

refer to program integrity unit and proposing new policy such as quantity restrictions and

further review by IB and MRB.

Fraud or Abuse of non-controlled drugs by beneficiaries

Twenty-three states, including California, have a documented process in place that identifies

potential fraud or abuse of non-controlled drugs by beneficiaries. California’ action includes

referral to program integrity unit, and IB investigations.

B. Prescription Drug Monitoring Program (PDMP)

Access

Forty-eight states, including California, have a PDMP.


6

California Medicaid has the ability to query state’s PDMP.

The California Department of Justice has a PDMP system called the Controlled Substance

Utilization Review and Evaluation System (CURES). This system is accessible by prescribers, law

enforcement, and regulatory boards with timely patient controlled substance history

information.

Thirty-six states, including California, do not have access to border-states’ PDMP information.

Barriers to Access

California barriers to access to state’s PDMP/CURES include enrollment delays because of

restructuring the CURES program and budgetary restrictions. California has taken steps and

beginning FFY 2016, a streamlined approval process for access (CURES) 2.0 is available and is

now fully operating.

C. Pain Management Control

General

Forty-six states, including California, do not require pain management providers to be certified.

Only four states have this requirement (Mississippi, Ohio, South Carolina and Texas).

Thirty-six states, including California, do not obtain the DEA Action Controlled Substance

Registrant’s File to identify prescribers not authorized to prescribe controlled drugs.

Forty-eight states, including California, does not apply DEA file to RetroDUR reviews. Two states

have this application, Michigan and New Hampshire.

Methadone

Thirty-nine states, including California, have measures in place to either monitor or manage the

prescribing of methadone for pain management. Actions from states include pharmacist

override, deny claims and require prior authorization, quantity limits, intervention letters,

morphine equivalent daily dose program and step therapy or clinical criteria.

Most of the eleven states that have not had measures in place in FFY 2015 are implementing

similar control in FFY 2016 and 2017.

In FFY 2016, California has removed methadone from the Medi-Cal contract drug list. This drug

is by treatment authorization request only.

D. Opioids

Short-acting

Thirty-five states, including California, have Point-of-Service (POS) edits to limit the quantity of

short-acting opioids.

States vary in the allowable number of units per day.

Twenty-one states have a maximum days’ supply per prescription limitation at 30 days’ supply.

Fourteen states, including California, use a variety of POS edits. For California, short-acting

opioids have an established maximum quantity per dispensing and a maximum of three (3)

dispensing within a 75-day period.


7

Long-acting

Thirty-nine states, including California, have POS edits in place to limit the long-acting opioids.

States were evenly split in allowing the maximum of two units/day or three units per day.

Twenty-one states have a maximum days’ supply of 30 days. Only one state, Pennsylvania, has a

maximum of 90 days.

Others, including California, use different quantity limit settings. California uses a maximum of

three dispensings within a 75-day period.

Concurrent use of opioids and benzodiazepines

Eleven states have edits in place to monitor concurrent use of opioids and benzodiazepines.

These edits include: 1) the use of prior authorization for one or both categories of drugs, 2)

asking clinical criteria questions, and 3) use of retrospective DUR to generate a near real time

intervention letter. Kentucky utilizes a standard ProDUR edits within First Data Bank (FDB) and

requires pharmacist intervention before processing combination of drugs.

California performed a retrospective DUR study in FFY 2016 and the study is currently in review.

E. Morphine Equivalent Daily Dose (MEDD)

Thirteen states have set recommended maximum MEDD measure. The lowest maximum MEDD

is North Dakota, at 90, the highest is North Carolina, at 750. Most common maximum MEDD

measure is at 120.

Thirty-seven states, including California, have not set recommended maximum MEDD measure.

Many of these states are taking steps to review data. Some states are at various stages of

implementing MEDD, such as working on a MEDD policy, (Arizona, Florida, Georgia, Missouri,

New Hampshire, South Carolina, and Tennessee). States are looking at establishing guidelines

based on CDC guidelines (Arkansas guidance recommends 100 mg; Ohio has guidelines for

ER/urgent care). States also taking different actions: sending informational alerts as first step

(Connecticut), using FDA approved maximum daily dose (DC, Hawaii), implementing pain

management program (Illinois), using ProDUR alerts (New Jersey), reviewing DUR data quarterly

(Nevada), using prior authorization criteria (Texas), setting up edits to implement MEDD

(Wisconsin, West Virginia). The rest are continuing to utilize quantity limit as a control.

Nineteen states, including California, provide information to prescribers on how to calculate the

MEDD. Nine states posted the calculator on their website. Others provided information in

various ways such as provider notice (Michigan), educational bulletin (California, Indiana),

targeted letters to prescribers (Arizona, Idaho, and Indiana), part of PDMP (Ohio), dose quantity

limit (North Dakota), on the authorization forms (Arkansas, Tennessee, and Virginia).

Nine states have an algorithm in state’s POS system that alerts the pharmacy provider that the

MEDD prescribed has exceeded.

Forty-one states, including California, do not have an algorithm in place.

F. Buprenorphine and Buprenorphine/Naloxone Combinations

Forty-one states have set total mg/day limits on the use of buprenorphine and

buprenorphine/naloxone combination drugs.


8

The total mg/day range from 12mg/day to 32mg/day. Most common mg/day limit is 24 mg/day.

Thirty-two states have no limit on the length of treatment. One state has a 6 month limit

(Georgia), one state has a 3 month limit (Idaho, Louisiana), and one state has a 12 months limit

(Illinois). Some have 2 years limit ( Maine, Wyoming)

California implemented restriction beginning June 1, 2015 with 120 dosage units (regardless of

strength) and a 30-day supply per dispensing.

Thirty-seven states do not require reducing the maximum mg/day allowable after a set period.

Thirteen states require reduction after a set period, reducing to 8mg/day (Florida, Mississippi,

Montana, Tennessee and Wyoming), 12 mg/day (Delaware), and 16mg/day (Idaho, Louisiana,

and Missouri). Four states look at dose tapering plan (Illinois, Maine, Michigan and Utah).

Forty states, including California, has at least one preferred buprenorphine/naloxone

combination product on preferred drug list (PDL). Ten states do not.

Twenty-seven states have edits in place to monitor use of opioids concurrently with any

buprenorphine drug. Only three states allow override (Maryland, Rhode Island, Virginia).

Twenty-three states, including California, do not have edits in place to monitor opioids being

used concurrently with any buprenorphine drug

G. Antipsychotics/Stimulants

Antipsychotics

Forty-one states, including California, have a documented program in place to either manage or

monitor the appropriate use of antipsychotic drugs in children.

Most states monitor all children, except Delaware monitoring children in foster care only. Other

monitoring includes use of edits (Arizona), use prior authorization for children 8 years of age or

less and on atypical antipsychotics and long acting atypical antipsychotics only (Illinois), use prior

authorization for 21 years of age and less (Tennessee), monitoring both adult and children

(Texas) and monitoring children 7 years of age or less (Wisconsin).

Each state includes a brief report to explain the specifics of the antipsychotic program.

Stimulants

Forty-seven states, including California, have documented restrictions or special program in

place to monitor, manage or control the use of stimulants.

Only three states do not (Kansas, Maryland, North Carolina)

Each state includes a brief explanation of the program.

IX. Innovative Practices Thirty-seven states, including California have initiated innovative practices during the reporting

year, in Attachment 6.


9

X. E-Prescribing Twenty-one states’ MMIS or pharmacy vendor have a portal to electronically provide patient

drug history data and pharmacy coverage limitations to a prescriber prior to prescribing, upon

inquiry.

Twenty-nine states, including California, do not.

Eleven states explained their e-prescribing evaluation methodology in Attachment 7 (Arizona,

Connecticut, Delaware, Florida, Louisiana, Michigan, Minnesota, Missouri, New Mexico,

Oklahoma, and Texas).

Forty-one states use NCPDP Origin Code that indicates the prescription source.

Nine states, including California, do not.

XI. Managed Care Organizations (MCOs) Thirty-seven states, including California, have MCOs.

Twenty-one states include pharmacy program in the capitation rate (carved-in)

Five states do not include pharmacy program in the capitation rate (Colorado, Georgia, Missouri,

Nevada and Tennessee)

Eleven states, including California, pharmacy program is partially included in the capitation rate.

There is variations in what is included and not included. For California, the carved out drugs are

selected HIV/AIDS, selected alcohol and heroin detoxification and dependency/treatment drugs,

selected coagulation factors and selected drugs to treatment psychiatric conditions.

Seventeen states, including California, set requirements for the MCO’s pharmacy benefits.

Requirements differ from state to states: Formulary review (California, Delaware, Illinois,

Maryland, Michigan, New Hampshire, New Jersey, New York, Pennsylvania, South Carolina,

Texas, Utah and Washington). Seven states have same preferred drug list (PDL) (Delaware,

Florida, Kansas, Mississippi, New Hampshire, Texas and West Virginia), two states have same

retrospective DUR criteria (Kansas, New Jersey) and four states have same Prospective DUR

(Florida, Kansas, Mississippi, and New Jersey).

QUALITY STRATEGIES 2016 UPDATES

1

National Strategy for Quality Improvement in Health Care

Three Aims:

1. Better Care

2. Health People/Healthy Communities

3. Affordable Care

Six Priorities:

1. Making care safer by reducing harm caused in the delivery of care

2. Ensuring that each person and family are engaged as partners in their care

3. Promoting effective communication and coordination of care

4. Promoting the most effective prevention and treatment practices for the leading causes of

mortality, starting with cardiovascular disease

5. Working with communities to promote wide use of best practices to enable healthy living

6. Making quality care more affordable for individuals, families, employers, and governments by

developing and spreading new health care delivery models.

Centers for Medicare & Medicaid Services (CMS)

Three Aims:

1. Better Care

2. Health People/Healthier Communities

3. Smarter Spending

Five Goals:

1. Make care safer by reducing harm caused by the delivery of care

2. Strengthen person and family engagement as partners in their care

3. Promote effective communication and coordination of care

4. Promote effective prevention and treatment of chronic disease

5. Work with communities to promote best practices of healthy living

DHCS Strategies for Quality Improvement in Health Care

Three linked-goals:

1. Enhance quality, including the patient care experience

2. Improve the health of all Californians

3. Reduce the Department’s per capital health care program cost

QUALITY STRATEGIES 2016 UPDATES

2

Seven Priorities:

1. Improve patient safety

2. Deliver effective, efficient, affordable care

3. Engage persons and families in their health

4. Enhance communication and coordination of care

5. Advance prevention

6. Foster healthy communities

7. Eliminate health disparities

DUR Quarterly Report – Version 1.0: January 24, 2017 2016 Q4 (OCTOBER 2016 – DECEMBER 2016)

1

QUARTERLY SUMMARY DRUG USE REVIEW (DUR) UTILIZATION REVIEW

REPORT PERIOD: 4th QUARTER 2016 (OCTOBER - DECEMBER 2016)

Executive Summary

The DUR quarterly report provides information on both prospective and retrospective drug utilization for the Medi-Cal Fee-for-Service (FFS) program. For this quarterly report, the prospective and retrospective data cover the fourth quarter of 2016 (2016 Q4). All tables can be found in Appendix A and definitions of selected terms can be found in Appendix B. Prospective DUR As shown in Table 1.1, overall drug claims, DUR drug claims, total alerts, total alert overrides, and total alert cancels all decreased in comparison to both the prior-year quarter (2015 Q4). A comparison between 2016 Q4 and 2016 Q3 showed very little change among the alert transactions by therapeutic problem type (Table 1.2) and the top 10 drugs for each of the 12 prospective DUR alerts (Tables 2.1-2.12). Retrospective DUR A comparison of 2016 Q4 to the prior-year quarter showed a 9% decrease in total utilizing beneficiaries and an 13% decrease in total paid claims (Table 3). When overall utilization from 2016 Q4 was compared to the prior quarter there were 3% decreases in both total utilizing beneficiaries and total paid claims. In 2016 Q4, all age groups except the 0-12 year age group posted decreases in total utilizing beneficiaries and total paid claims in comparison to the prior quarter (Table 4). Historically, this age group posts increases in both utilizing beneficiaries and total paid claims from Q3 to Q4, skewed heavily by drugs related to cold and flu season, which peaks in California during in late Q4 and early Q1. Similarly, as shown in Table 5, the four drug therapeutic categories that posted increases in total paid claims and percent of utilizing beneficiaries with a paid claim in comparison to the prior quarter are related to cold and flu season: PENICILLINS, BETA-ADRENERGIC AGENTS, INHALED, SHORT ACTING, ANALGESIC/ANTIPYRETICS, NON-SALICYLATE, and MACROLIDES. Corresponding increases can be seen in the review of the top 20 drugs by total utilizing beneficiaries (Table 6) for the following drugs in the categories listed above: AMOXICILLIN, ALBUTEROL SULFATE, ACETAMINOPHEN, and AZITHROMYCIN. PROMETHAZINE/DEXTROMETHORPHAN also increased in comparison to the prior quarter, with a 67% increase in total paid claims. In addition, Table 6 shows that two years after being re-classified as Schedule II Controlled substances (effective October 6, 2014), HYDROCODONE/ACETAMINOPHEN continues to post decreases in total paid claims in comparison to the prior quarter (decreased by 12%) and to the prior-year quarter (decreased by 24%).


2

Appendix A: Prospective and Retrospective DUR Tables

Tables 1.1-1.2. Summary of Prospective DUR Alert Transactions. Table 1.1 provides summary level data (by volume) on pharmacy claims and DUR alert activities, including data and percent change from the prior quarter and prior-year quarter. Alerts are generated after adjudication of drug claims that exceed or otherwise fall outside of certain prescribed parameters. Please see Appendix B for definitions of terms used in this DUR report.

Table 1.1: Summary of Alert Transactions

Category

Current Quarter 2016 Q4

(Oct – Dec 2016)

Prior Quarter 2016 Q3

(Jul – Sep 2016)

% Change from Prior

Quarter

Prior-Year Quarter 2015 Q4

(Oct – Dec 2015)

% Change from

Prior-Year Quarter

Drug Claims 7,965,586 8,281,627 -3.8% 8,843,583 -9.9%

DUR Drug Claims 3,973,976 4,121,197 -3.6% 4,570,055 -13.0%

Total Alerts 958,615 990,135 -3.2% 1,025,190 -6.5%

Total Alert Overrides 565,900 583,135 -3.0% 596,651 -5.2%

Total Alert Cancels 163 218 -25.2% 269 -39.4%

Note: Drug claims receiving multiple alerts can be adjudicated by pharmacists by responding to only one conflict code, followed by an intervention code and outcome code. The remaining alerts on the claim cannot be tracked as they are overridden by the pharmacist’s response to a single alert. For example, a single claim can generate up to eight different alerts, but the pharmacist can override all eight alerts by choosing to override only one alert. In addition, the number of cancelled alerts may be underrepresented due to the system’s inability to capture claims that were not adjudicated.

Table 1.2 provides a summary of the number of drug claims and alerts generated for each therapeutic problem type (sorted by alert frequency). Total alerts not adjudicated may be overrepresented, as claims with multiple alerts that have been adjudicated under one alert will show up as not adjudicated for the remaining alerts.

Table 1.2: Summary of Alert Transactions by Therapeutic Problem Type – 2016 Q4

Therapeutic Problem Type Total Alerts

Total Alert Over-rides

% Alert Over-rides

Total Alert

Cancels % Alert Cancels

Total Alerts

Not Adjud-icated

% Alerts

Not Adjud-icated

Early Refill (ER) 299,110 95,795 32.0% 67 0.0% 203,248 68.0%

Ingredient Duplication (ID) 213,060 149,356 70.1% 32 0.0% 63,672 29.9%

Therapeutic Duplication (TD) 180,762 130,748 72.3% 23 0.0% 49,991 27.7%

Late Refill (LR) 117,682 89,135 75.7% 14 0.0% 28,533 24.2%

Total High Dose (HD) 50,371 30,982 61.5% 8 0.0% 19,381 38.5%

Additive Toxicity (AT) 35,603 28,159 79.1% 6 0.0% 7,438 20.9%

Total Low Dose (LD) 25,894 16,123 62.3% 1 0.0% 9,770 37.7%

Drug-Pregnancy (PG) 23,500 16,262 69.2% 5 0.0% 7,233 30.8%

Drug-Drug (DD) 9,528 7,174 75.3% 1 0.0% 2,353 24.7%

Drug-Disease (MC) 2,873 2,008 69.9% 0 0.0% 865 30.1%

Drug-Allergy (DA) 184 125 67.9% 0 0.0% 59 32.1%

Drug-Age (PA) 48 33 68.8% 0 0.0% 15 31.3%


3

Tables 2.1-2.12. Prospective DUR Alert Transactions by Therapeutic Problem Type. Each of the following tables provides greater detail of each of the 12 DUR alerts with the top 10 drugs generating each respective alert. For each of the top 10 drugs, data are provided for the total number of adjudicated alerts, alert overrides, alert cancels, paid claims, and the percentage of paid claims with alert overrides. Tables are listed in order of DUR alert priority, which is determined by the DUR Board. Table 2.1: Top 10 Drugs by Therapeutic Problem Type – Drug-Allergy (DA) – 2016 Q4

Rank Drug Generic Name/Ingredient Name

Total Adjudicated

Alerts Total Alert Overrides

Total Alert Cancels

Total Paid

Claims

% of Paid Claims

with Alert Overrides

1 PHENYTOIN SODIUM EXTENDED 74 74 0 2,379 3.1%

2 PHENYTOIN 53 53 0 844 6.3%

3 OXYCODONE HCL/ACETAMINOPHEN 6 6 0 6,790 0.1%

4 AMOXICILLIN 5 5 0 41,418 0.0%

5 IBUPROFEN 4 4 0 87,569 0.0%

6 OXYCODONE HCL 4 4 0 4,320 0.1%

7 SULFAMETHOXAZOLE/TRIMETHOPRIM 3 3 0 18,206 0.0%

8 SOMATROPIN 2 2 0 2,073 0.1%

9 CEPHALEXIN 1 1 0 25,648 0.0%

10 HALOPERIDOL 1 1 0 20,961 0.0%

Table 2.2: Top 10 Drugs by Therapeutic Problem Type – Drug-Pregnancy (PG) – 2016 Q4


Total Adjudicated


Total Alert Cancels

Total Paid

Claims

% of Paid Claims


1 IBUPROFEN 14,535 14,530 5 87,569 16.6%

2 NORETHINDRONE 2,544 2,544 0 8,141 31.2%

3 SULFAMETHOXAZOLE/TRIMETHOPRIM 486 486 0 18,206 2.7%

4 METHYLERGONOVINE MALEATE 379 379 0 211 179.6%

5 ASPIRIN 328 328 0 72,600 0.5%

6 MISOPROSTOL 305 305 0 673 45.3%

7 NAPROXEN 290 290 0 12,781 2.3%

8 DOXYCYCLINE HYCLATE 269 269 0 5,118 5.3%

9 LORAZEPAM 140 140 0 10,895 1.3%

10 LISINOPRIL 128 128 0 32,538 0.4%

Table 2.3: Top 10 Drugs by Therapeutic Problem Type – Drug-Disease (MC) – 2016 Q4


Total Adjudicated


Total Alert Cancels

Total Paid

Claims

% of Paid Claims


1 POTASSIUM CHLORIDE 542 542 0 3,581 15.1%

2 HALOPERIDOL 432 432 0 20,961 2.1%

3 METFORMIN HCL 401 401 0 40,327 1.0%

4 CARBAMAZEPINE 78 78 0 3,688 2.1%

5 METOPROLOL TARTRATE 72 71 1 8,281 0.9%

6 METOPROLOL SUCCINATE 72 72 0 5,117 1.4%

7 HALOPERIDOL DECANOATE 67 67 0 3,893 1.7%

8 ATENOLOL 41 41 0 6,536 0.6%

9 SOMATROPIN 38 38 0 2,073 1.8%

10 TRIFLUOPERAZINE HCL 37 37 0 1,075 3.4%


4

Table 2.4: Top 10 Drugs by Therapeutic Problem Type – Drug-Drug Interaction (DD) – 2016 Q4


Total Adjudicated


Total Alert Cancels

Total Paid

Claims

% of Paid Claims


1 GEMFIBROZIL 605 604 1 2,924 20.7%

2 ELVITEG/COBI/EMTRIC/TENOFO ALA 552 552 0 9,405 5.9%

3 SIMVASTATIN 441 441 0 13,136 3.4%

4 METOCLOPRAMIDE HCL 331 331 0 5,253 6.3%

5 ATORVASTATIN CALCIUM 325 325 0 24,062 1.4%

6 DARUNAVIR ETHANOLATE 312 312 0 6,536 4.8%

7 AMLODIPINE BESYLATE 272 272 0 21,374 1.3%

8 ETRAVIRINE 187 187 0 1,314 14.2%

9 ZIPRASIDONE HCL 183 183 0 19,309 0.9%

10 DARUNAVIR/COBICISTAT 178 178 0 4,477 4.0%

Table 2.5: Top 10 Drugs by Therapeutic Problem Type – Therapeutic Duplication (TD) – 2016 Q4


Total Adjudicated


Total Alert Cancels

Total Paid

Claims

% of Paid Claims


1 QUETIAPINE FUMARATE 24,135 24,132 3 136,732 17.6%

2 OLANZAPINE 15,286 15,282 4 72,911 21.0%

3 RISPERIDONE 14,704 14,703 1 85,337 17.2%

4 LURASIDONE HCL 9,349 9,349 0 35,939 26.0%

5 CLOZAPINE 6,580 6,578 2 18,932 34.7%

6 PALIPERIDONE PALMITATE 5,358 5,358 0 15,234 35.2%

7 TRAZODONE HCL 5,116 5,115 1 11,205 45.6%

8 ZIPRASIDONE HCL 4,566 4,566 0 19,309 23.6%

9 ALBUTEROL SULFATE 4,364 4,364 0 50,294 8.7%

10 PREDNISONE 3,548 3,548 0 17,238 20.6%

Table 2.6: Top 10 Drugs by Therapeutic Problem Type – Overutilization (ER) – 2016 Q4


Total Adjudicated


Total Alert Cancels

Total Paid

Claims

% of Paid Claims



2 ARIPIPRAZOLE 7,530 7,526 4 100,401 7.5%

3 RISPERIDONE 5,422 5,421 1 85,337 6.4%

4 OLANZAPINE 4,726 4,725 1 72,911 6.5%

5 BENZTROPINE MESYLATE 4,519 4,519 0 56,347 8.0%

6 LITHIUM CARBONATE 2,792 2,789 3 30,213 9.2%

7 LURASIDONE HCL 2,480 2,478 2 35,939 6.9%

8 ASPIRIN 2,466 2,463 3 72,600 3.4%

9 METFORMIN HCL 1,952 1,952 0 40,327 4.8%

10 HALOPERIDOL 1,746 1,746 0 20,961 8.3%


5

Table 2.7: Top 10 Drugs by Therapeutic Problem Type – Underutilization (LR) – 2016 Q4


Total Adjudicated


Total Alert Cancels

Total Paid

Claims

% of Paid Claims


1 ARIPIPRAZOLE 17,314 17,312 2 100,401 17.2%


3 RISPERIDONE 10,369 10,368 1 85,337 12.1%

4 OLANZAPINE 7,726 7,726 0 72,911 10.6%

5 BENZTROPINE MESYLATE 7,189 7,189 0 56,347 12.8%

6 LURASIDONE HCL 5,295 5,295 0 35,939 14.7%


8 LEVOTHYROXINE SODIUM 3,074 3,074 0 26,157 11.8%

9 ATORVASTATIN CALCIUM 2,460 2,460 0 24,062 10.2%

10 HALOPERIDOL 2,458 2,455 3 20,961 11.7%

Table 2.8: Top 10 Drugs by Therapeutic Problem Type – Additive Toxicity (AT) – 2016 Q4


Total Adjudicated


Total Alert Cancels

Total Paid

Claims

% of Paid Claims


1 ARIPIPRAZOLE 1,711 1,711 0 100,401 1.7%



4 CLONAZEPAM 1,233 1,233 0 7,917 15.6%

5 HALOPERIDOL 1,132 1,132 0 20,961 5.4%

6 OLANZAPINE 870 870 0 72,911 1.2%

7 ZOLPIDEM TARTRATE 685 685 0 4,388 15.6%

8 RISPERIDONE 626 626 0 85,337 0.7%

9 TRAZODONE HCL 570 570 0 11,205 5.1%

10 CHLORPROMAZINE HCL 535 535 0 5,915 9.0%

Table 2.9: Top 10 Drugs by Therapeutic Problem Type – Ingredient Duplication (ID) – 2016 Q4


Total Adjudicated


Total Alert Cancels

Total Paid

Claims

% of Paid Claims



2 OLANZAPINE 14,239 14,239 0 72,911 19.5%

3 ARIPIPRAZOLE 13,291 13,290 1 100,401 13.2%

4 RISPERIDONE 11,796 11,790 6 85,337 13.8%

5 CLOZAPINE 6,069 6,068 1 18,932 32.1%

6 ALBUTEROL SULFATE 5,958 5,957 1 50,294 11.8%

7 LURASIDONE HCL 5,342 5,341 1 35,939 14.9%

8 ZIPRASIDONE HCL 3,717 3,716 1 19,309 19.2%

9 HALOPERIDOL 3,633 3,633 0 20,961 17.3%

10 LEVOTHYROXINE SODIUM 2,896 2,896 0 26,157 11.1%


6

Table 2.10: Top 10 Drugs by Therapeutic Problem Type – Drug-Age (PA) – 2016 Q4


Total Adjudicated


Total Alert Cancels

Total Paid

Claims

% of Paid Claims


1 PALIVIZUMAB 50 50 0 1,268 3.9%

2 AMITRIPTYLINE HCL 18 18 0 3,570 0.5%

3 DOXEPIN HCL 8 8 0 371 2.2%

4 RISPERIDONE 7 7 0 85,337 0.0%

5 TRIHEXYPHENIDYL HCL 6 6 0 5,617 0.1%

6 AMOXICILLIN 4 4 0 41,418 0.0%

7 DEXMETHYLPHENIDATE HCL 4 4 0 3,407 0.1%

8 HYDROCODONE/ACETAMINOPHEN 4 4 0 39,604 0.0%

9 LEVOTHYROXINE SODIUM 4 4 0 26,157 0.0%

10 PREDNISONE 4 4 0 17,238 0.0%

Table 2.11: Top 10 Drugs by Therapeutic Problem Type – High Dose (HD) – 2016 Q4


Total Adjudicated


Total Alert Cancels

Total Paid

Claims

% of Paid Claims


1 OLANZAPINE 7,919 7,917 2 72,911 10.9%

2 RISPERIDONE 2,733 2,733 0 85,337 3.2%


4 HYDROCODONE/ACETAMINOPHEN 2,158 2,157 1 39,604 5.4%

5 IBUPROFEN 1,378 1,376 2 87,569 1.6%

6 GABAPENTIN 1,262 1,262 0 21,787 5.8%

7 AMOXICILLIN 1,201 1,201 0 41,418 2.9%

8 ARIPIPRAZOLE 1,051 1,050 1 100,401 1.0%

9 AMOXICILLIN/POTASSIUM CLAV 763 763 0 10,637 7.2%

10 FAMOTIDINE 738 738 0 12,878 5.7%

Table 2.12: Top 10 Drugs by Therapeutic Problem Type – Low Dose (LD) – 2016 Q4


Total Adjudicated


Total Alert Cancels

Total Paid

Claims

% of Paid Claims



2 GABAPENTIN 1,638 1,638 0 21,787 7.5%

3 AZITHROMYCIN 817 817 0 26,875 3.0%

4 ALBUTEROL SULFATE 747 747 0 50,294 1.5%

5 AMOXICILLIN 601 601 0 41,418 1.5%

6 ERYTHROMYCIN ETHYLSUCCINATE 579 579 0 1,757 33.0%

7 CLONIDINE HCL 570 570 0 9,056 6.3%

8 DIVALPROEX SODIUM 555 555 0 11,818 4.7%

9 AMOXICILLIN/POTASSIUM CLAV 447 447 0 10,637 4.2%

10 CEPHALEXIN 425 425 0 25,648 1.7%


7

Table 3. Summary of Medi-Cal FFS Pharmacy / Drug Utilization Measures. This table shows pharmacy utilization for the Medi-Cal FFS population, including the percent change from the prior quarter and prior-year quarter. Please note that all retrospective data tables exclude claims from beneficiaries in the Family Planning, Access, Care, and Treatment (Family PACT) program and the California Children's Services/ Genetically Handicapped Persons Program (CCS/GHPP) because they have different guidelines concerning access to prescription drugs than other Medi-Cal FFS beneficiaries.

Table 3: Pharmacy Utilization Measures for the Medi-Cal FFS Population

Category


Prior Quarter 2016 Q3

Prior-Year Quarter 2015 Q4

% Change from Prior

Quarter

% Change from

Prior-Year Quarter

Total Eligible FFS Beneficiaries 2,408,495 2,488,808 2,745,704 -3.2% -10.0%

Total Utilizing FFS Beneficiaries 751,505 772,130 824,497 -2.7% -9.0%

Total Paid Rx Claims 2,526,060 2,607,270 2,887,863 -3.1% -12.9%

Average Paid Rx Claims per Eligible FFS Beneficiary

1.05 1.05 1.05 0.1% -2.9%

Average Paid Rx Claims per Utilizing FFS Beneficiary

3.36 3.38 3.50 -0.5% -4.5%

Total Reimbursement Paid ($) to Pharmacies

$567,660,492 $573,733,431 $717,704,785 -1.1% -20.7%

Average Reimbursement Paid ($) per Eligible FFS Beneficiary

$235.69 $230.53 $261.39 2.2% -11.8%

Average Reimbursement Paid ($) per Utilizing FFS Beneficiary

$755.36 $743.05 $870.48 1.7% -12.9%

Average Reimbursement Paid ($) per Paid Rx Claim

$224.72 $220.05 $248.52 2.1% -8.9%

Table 4. Pharmacy Utilization by Age Group in the Medi-Cal FFS Population. This table presents pharmacy utilization data broken out by age group, including the percent change from the prior quarter and prior-year quarter.

Table 4: Pharmacy Utilization by Age Group in the Medi-Cal FFS Population

Age Group (years)


Total Paid Claims

% Change Total Paid

Claims from

Prior Quarter

% Change Total Paid

Claims from Prior-Year

Quarter


Total Utilizing Beneficiaries

% Change Total Utilizing

Beneficiaries from

Prior Quarter

% Change Total Utilizing

Beneficiaries from

Prior-Year Quarter

0 – 12 239,566 7.3% -18.4% 101,134 3.9% -17.7%

13 – 18 120,446 -7.9% -16.0% 37,201 -10.5% -17.7%

19 – 39 760,662 -4.3% -10.5% 244,269 -4.4% -8.0%

40 – 64 1,141,822 -3.4% -11.3% 278,025 -2.1% -4.6%

65+ 247,297 -4.2% -16.0% 84,210 -2.3% -7.9%

Total* 2,526,060 -3.1% -12.5% 751,505 -2.7% -8.9%

* Unknowns represent less than 1% of total


8

Table 5. Top 20 Drug Therapeutic Categories in the Medi-Cal FFS Population. This table presents utilization of the top 20 drug therapeutic categories, by percentage of utilizing beneficiaries with a paid claim. The current quarter is compared to the prior quarter and prior-year quarter in order to illustrate changes in utilization and reimbursement dollars paid to pharmacies for these top utilized drugs. The prior-year quarter ranking of the drug therapeutic category is listed for reference.

Table 5: Top 20 Drug Therapeutic Categories by Percentage of Utilizing Beneficiaries with a Paid Claim

Rank

Last Year Rank Drug Therapeutic Category Description


Total Paid

Claims

% Change

Total Paid

Claims from Prior

Quarter

% Change

Total Paid

Claims from Prior-Year

Quarter


Total Utilizing Benefici-

aries

% Utilizing Benefici-

aries with a Paid

Claim

% Change Utilizing Benefici-aries with

a Paid Claim from Prior

Quarter

% Change Utilizing Benefici-

aries with a Paid

Claim from Prior- Year

Quarter

1 1 ANTIPSYCHOTIC,ATYPICAL,DOPAMINE,SEROTONIN ANTAGNST

396,078 -1.1% 0.5% 135,905 18.1% 0.4% 1.8%

2 2 NSAIDS, CYCLOOXYGENASE INHIBITOR - TYPE ANALGESICS

105,990 -4.3% -17.1% 91,389 12.2% -0.2% -1.1%

3 3 PENICILLINS 56,187 7.6% -21.0% 50,967 6.8% 0.6% -1.0%

4 5 ANALGESIC/ANTIPYRETICS, SALICYLATES

71,616 -3.6% -7.8% 47,211 6.3% -0.1% 0.1%

5 4 NARCOTIC ANALGESIC AND NON-SALICYLATE ANALGESIC

56,538 -12.2% -25.4% 44,856 6.0% -0.6% -1.2%

6 6 ANTIPSYCHOTICS, ATYP, D2 PARTIAL AGONIST/5HT MIXED

103,239 -1.2% 2.3% 44,718 6.0% 0.1% 0.6%

7 7 LAXATIVES AND CATHARTICS 51,854 -7.7% -14.6% 34,102 4.5% -0.3% -0.4%

8 8 BETA-ADRENERGIC AGENTS, INHALED, SHORT ACTING

45,236 15.4% -18.7% 33,462 4.5% 0.8% -0.4%

9 10 IRON REPLACEMENT 40,600 -11.1% -9.5% 30,634 4.1% -0.4% -0.1%

10 9 ANTICONVULSANTS 78,179 -9.0% -16.9% 30,256 4.0% -0.4% -0.3%

11 12 ANTIHISTAMINES - 2ND GENERATION

45,566 -2.7% -10.5% 29,775 4.0% 0.0% -0.1%

12 11 ANTIHYPERTENSIVES, ACE INHIBITORS

43,090 -7.1% -18.7% 28,232 3.8% -0.2% -0.4%

13 13 ANTIHYPERLIPIDEMIC - HMG COA REDUCTASE INHIBITORS

43,033 -6.9% -14.0% 27,823 3.7% -0.2% -0.1%

14 17 ANTIHYPERGLYCEMIC, BIGUANIDE TYPE

38,194 -5.9% -11.8% 25,390 3.4% -0.1% -0.1%

15 21 ANTIPARKINSONISM DRUGS,ANTICHOLINERGIC

61,794 -2.2% -3.5% 24,479 3.3% 0.0% 0.2%

16 15 ANALGESIC/ANTIPYRETICS,NON-SALICYLATE

25,692 13.0% -18.8% 23,924 3.2% 0.4% -0.4%

17 19 CEPHALOSPORINS - 1ST GENERATION

24,420 -12.0% -15.0% 22,819 3.0% -0.3% -0.2%

18 14 PRENATAL VITAMIN PREPARATIONS 25,148 -15.1% -24.6% 22,277 3.0% -0.4% -0.6%

19 18 TOPICAL ANTI-INFLAMMATORY STEROIDAL

25,948 -13.0% -24.5% 21,351 2.8% -0.3% -0.5%

20 16 MACROLIDES 23,507 27.8% -24.9% 21,292 2.8% 0.7% -0.6%


9

Table 6. Top 20 Drugs in the Medi-Cal FFS Population. This table presents utilization of the top 20 drugs, by percentage of utilizing beneficiaries with a paid claim. The current quarter is compared to the prior quarter and prior-year quarter in order to illustrate changes in utilization for these drugs. The prior-year quarter ranking of each drug is listed for reference. Utilization of drugs for Medi-Cal fee-for-service beneficiaries also includes carved-out drugs utilized by beneficiaries in Medi-Cal managed care plans. Carved-out drugs are listed below in bolded and italicized print.

Table 6: Top 20 Drugs by Percentage of Utilizing Beneficiaries with a Paid Claim

Rank

Last Year Rank Drug Description


Total Paid

Claims

% Change Total Paid

Claims from Prior

Quarter

% Change Total Paid

Claims from

Prior-Year Quarter


Total Utilizing Benefici-

aries

% Utilizing Benefici-aries with

a Paid Claim

% Change of Utilizing Benefici-

aries with a Paid Claim

from Prior

Quarter

% Change of Utilizing Benefici-

aries with a Paid Claim

from Prior-Year

Quarter

1 1 IBUPROFEN 87,045 -3.3% -17.2% 77,433 10.3% -0.1% -1.0%

2 2 QUETIAPINE FUMARATE 136,584 -0.1% 2.1% 53,007 7.1% 0.2% 0.8%

3 3 ASPIRIN 71,598 -3.5% -7.5% 47,193 6.3% -0.1% 0.1%

4 5 ARIPIPRAZOLE 100,171 -1.9% -0.3% 43,596 5.8% 0.1% 0.5%

5 4 AMOXICILLIN 40,893 8.9% -21.6% 37,848 5.0% 0.5% -0.8%

6 6 ALBUTEROL SULFATE 47,069 18.3% -19.2% 35,053 4.7% 0.9% -0.5%

7 9 RISPERIDONE 84,632 -2.2% -5.3% 34,284 4.6% 0.0% 0.2%

8 8 DOCUSATE SODIUM 48,992 -6.5% -13.0% 32,835 4.4% -0.2% -0.3%

9 7 HYDROCODONE/ ACETAMINOPHEN

39,070 -11.7% -23.7% 31,958 4.3% -0.4% -0.8%

10 11 FERROUS SULFATE 40,556 -9.6% -7.4% 30,609 4.1% -0.3% 0.0%

11 10 LORATADINE 45,050 -2.8% -10.4% 29,539 3.9% 0.0% -0.1%

12 16 OLANZAPINE 72,827 -0.2% 3.9% 27,895 3.7% 0.1% 0.5%

13 13 METFORMIN HCL 38,194 -5.6% -11.4% 25,390 3.4% -0.1% -0.1%

14 12 ACETAMINOPHEN 25,692 12.6% -19.1% 23,924 3.2% 0.4% -0.4%

15 14 CEPHALEXIN 24,322 -12.0% -14.8% 22,802 3.0% -0.3% -0.2%

16 18 BENZTROPINE MESYLATE 56,322 -1.5% -2.7% 22,435 3.0% 0.0% 0.2%

17 17 LISINOPRIL 31,553 -5.9% -15.3% 20,830 2.8% -0.1% -0.2%

18 15 AZITHROMYCIN 21,267 34.2% -24.7% 19,771 2.6% 0.7% -0.6%

19 19 PROMETHAZINE/ DEXTROMETHORPHAN

21,118 67.2% -13.9% 18,349 2.4% 1.0% -0.1%

20 20 FOLIC ACID 30,965 -5.1% -9.8% 17,624 2.3% -0.1% -0.1%


10

APPENDIX B: Definition of terms. Adjudicate: To pay or deny drug claims after evaluating the claim for coverage requirements Average Reimbursement ($): A measure of the mean value of the reimbursement in dollars; the sum of the reimbursement divided by the number measured (in dollars). Beneficiary: A person who has been determined eligible for Medi-Cal, as according to the California Code of Regulations 50024 Eligible FFS beneficiary: A Medi-Cal FFS beneficiary that qualifies for drug benefits Quarter: One fourth, ¼, 25% or .25 of a year measured in months. Reimbursement: The reimbursement paid to Medi-Cal pharmacy providers for legend and nonlegend drugs dispensed to Medi-Cal Fee-for-Service (FFS) beneficiaries. Reimbursement is determined in accordance with CA Welfare and Institutions Code Section 14105.45(b)(1). Drug therapeutic category: Drug therapeutic categories are grouping of drugs at various hierarchy levels and characteristics that may be similar in chemical structure, pharmacological effect, clinical use, indications, and/or other characteristics of drug products. Utilizing FFS beneficiary: A Medi-Cal beneficiary with at least one FFS prescription filled during the measurement period

Version 1.0: Last updated January 17, 2017 Page 1 of 4

PHYSICIAN-ADMINISTERED DRUGS: 3RD QUARTER 2016 Utilization of physician-administered drugs during the third quarter of 2016 (July – September 2016) is presented below, stratified by category. In order to show changes in utilization over time, Table 1 shows the comparison to the prior quarter (2016 Q2) and Table 2 shows the comparison to the prior-year quarter (2015 Q3).

Table 1: 2016 Q3 Physician-Administered Drugs: Change from 2016 Q2 (one quarter)

Category Total

Utilizing Beneficiaries

% Change from

2016 Q2

Total Paid Claims

% Change

from 2016 Q2

Total Reimbursement

Dollars Paid

% Change from

2016 Q12

PHYSICIAN ADMINISTERED DRUG - NDC NOT REQUIRED (vaccines, hyaluronate)

21,603 27.5% 32,644 18.9% $869,483 -2.8%

PHYSICIAN ADMINISTERED DRUG - NDC REQUIRED

275,321 -3.2% 633,942 -7.3% $66,951,529 -4.4%

MISCELLANEOUS PRODUCT - REPORTING REQUIRED (supplies, immune globulin, IV solutions)

101,337 -15.0% 209,248 -15.8% $2,390,405 -16.9%

TOTAL 398,261 -5.3% 875,834 -8.8% $70,211,417 -4.9%

Table 2: 2016 Q3 Physician-Administered Drugs: Change from 2015 Q3 (one year)

Category Total


% Change from

2015 Q3

Total Paid Claims

% Change

from 2015 Q3

Total Reimbursement

Dollars Paid

% Change from

2015 Q3

PHYSICIAN ADMINISTERED DRUG - NDC NOT REQUIRED (vaccines, hyaluronate)

21,603 -7.1% 32,644 -7.9% $869,483 6.0%

PHYSICIAN ADMINISTERED DRUG - NDC REQUIRED

275,321 -8.2% 633,942 -12.0% $66,951,529 -6.6%

MISCELLANEOUS PRODUCT - REPORTING REQUIRED (supplies, immune globulin, IV solutions)

101,337 -23.2% 209,248 -25.0% $2,390,405 -26.8%

TOTAL 398,261 -12.5% 875,834 -15.4% $70,211,417 -7.3%

The following three tables show the top 20 physician-administered drugs by total utilizing beneficiaries (Table 3), total reimbursement dollars paid (Table 4), and reimbursement paid per utilizing beneficiary (Table 5). Each table has the comparison to the prior quarter and the prior-year quarter, for reference. In addition, the prior-year ranking is given to show changes in utilization of a drug over time.


Table 3: Top 20 Physician-Administered Drugs by Total Utilizing Beneficiaries

Rank

Last Year Rank

HCPCS Code Drug Description

2016 Q3 Total


% Change Total Utilizing Beneficiaries from 2016 Q2

% Change Total Utilizing Beneficiaries from 2015 Q3

2016 Q3 Total

Reimbursement Dollars Paid

2016 Q3 Total Paid

Claims

1 1 J3490 MEDROXYPROGESTERONE ACETATE

41,145 -4.4% -10.9% $2,661,588 42,027

2 2 J3490 LEVONORGESTREL 30,233 1.1% -11.1% $891,982 31,549

3 5 S4993 LEVONORGESTREL-ETHIN ESTRADIOL

22,485 1.9% -8.1% $2,722,965 22,840

4 4 J2405 ONDANSETRON HCL/PF

21,637 -4.9% -12.6% $120,482 26,299

5 3 J3490 ULIPRISTAL ACETATE

21,599 -1.3% -20.6% $608,237 22,778

6 6 J1885 KETOROLAC TROMETHAMINE

18,309 -4.9% -3.9% $114,260 20,284

7 7 X7700 0.9 % SODIUM CHLORIDE

14,868 -4.9% -3.3% $363,595 24,808

8 8 J2270 MORPHINE SULFATE

12,505 -0.9% -13.0% $82,594 14,927

9 14 Q0144 AZITHROMYCIN 11,132 14.4% 19.1% $96,963 11,635

10 10 J0696 CEFTRIAXONE SODIUM

10,124 -0.8% -8.0% $63,426 11,142

11 13 Z7610 ACETAMINOPHEN 9,590 -4.3% 0.3% $81,983 11,220

12 9 S4993 NORGESTIMATE-ETHINYL ESTRADIOL

9,588 -10.9% -22.2% $1,078,103 9,817

13 12 J7307 ETONOGESTREL 9,050 -7.2% -5.4% $6,554,939 9,050

14 11 J1170 HYDROMORPHONE HCL

7,869 -8.7% -24.6% $65,045 10,602

15 15 Z7610 IBUPROFEN 7,684 -7.9% -12.5% $62,227 7,997

16 16 Z7610 HYDROCODONE/ ACETAMINOPHEN

7,411 -1.6% -15.2% $78,899 8,110

17 17 J3010 FENTANYL CITRATE/PF

6,680 -13.4% -21.2% $34,288 7,367

18 19 J1100 DEXAMETHASONE SOD PHOSPHATE

6,486 -13.1% -10.2% $46,914 8,769

19 18 J7303 ETONOGESTREL/ ETHINYL ESTRADIOL

6,426 -4.0% -20.3% $705,754 6,459

20 22 S0191 MISOPROSTOL 6,139 -4.3% -2.0% $11,873 6,188


Table 4: Top 20 Physician-Administered Drugs by Total Reimbursement Dollars Paid

Rank

Last Year Rank


2016 Q3 Total

Reimburse-ment

Dollars Paid

% Change Total

Reimburse-ment

Dollars from 2016 Q2

% Change Total

Reimburse-ment Dollars from 2015 Q3

2016 Q3 Total


2016 Q3 Total Paid

Claims

1 3 J7189

COAGULATION FACTOR VIIA,RECOMB

(NOVOSEVEN®)1

$8,759,469 61.7% 164.7% 36 197

2 1 J7307 ETONOGESTREL $6,554,939 -7.1% -5.6% 9,050 9,050

3 2 J7302 LEVONORGESTREL $3,422,638 -9.8% -6.2% 4,946 4,964

4 6 S4993 LEVONORGESTREL-ETHIN ESTRADIOL

$2,722,965 2.2% -9.3% 22,485 22,840

5 5 J3490 MEDROXYPROGESTERONE ACETATE

$2,661,588 -6.0% -12.0% 41,145 42,027

6 4 J9355 TRASTUZUMAB $2,596,735 -5.4% -14.6% 283 890

7 11 J1745 INFLIXIMAB $2,249,292 1.1% 13.7% 455 919

8 9 J7300 INTRAUTERINE COPPER CONTRACEPTIVE

$2,055,909 -6.2% -17.7% 3,174 3,182

9 10 Q4081 EPOETIN ALFA (100 UNITS) $1,887,725 -18.0% -14.9% 1,765 36,516

10 8 J7192

ANTIHEMOPH.FVIII,FULL LENGTH (INCLUDES

ADVATE®, HELIXATE®,

AND KOGENATE®)

$1,651,634 -33.2% -35.8% 54 134

11 7 J2505 PEGFILGRASTIM $1,598,817 -24.3% -42.5% 246 461

12 13 J7304 NORELGESTROMIN/ETHIN.ESTRADIOL

$1,457,505 -9.4% -13.5% 4,411 4,474

13 16 J1300 ECULIZUMAB $1,393,173 11.1% -3.5% 27 129

14 12 J9019 ASPARAGINASE (ERWINIA CHRYSAN)

$1,343,214 -42.1% -30.1% 24 171

15 22 J9266 PEGASPARGASE $1,244,327 0.4% 32.8% 120 161

16 23 J9306 PERTUZUMAB $1,125,644 -2.2% 22.1% 110 683

17 14 J9035 BEVACIZUMAB $1,092,999 -12.9% -35.0% 160 401

18 17 S4993 NORGESTIMATE-ETHINYL ESTRADIOL

$1,078,103 -12.3% -21.3% 9,588 9,817

19 26 J7301 LEVONORGESTREL $959,281 6.5% 39.6% 1,486 1,488

20 21 J3490 LEVONORGESTREL $891,982 -2.1% -5.1% 30,233 31,549 1There were a total of 120 paid claims for this drug in 2015 Q3 and 156 paid claims for this drug in 2016 Q2, compared with

197 paid claims in 2016 Q3. Increased utilization is driving some of the increased costs, but does not account for all of the increase in total reimbursement dollars.


Table 5: Top 20 Physician-Administered Drugs by Reimbursement Paid per Utilizing Beneficiary

Rank

Last Year Rank


2016 Q3 Reimburse-

ment Dollars Paid per Utilizing Beneficiary

% Change Reimburse-

ment Dollars Paid per Utilizing

Beneficiary from 2016 Q2

% Change Reimburse-

ment Dollars Paid per Utilizing

Beneficiary from 2015 Q3

2016 Q3 Total

Reimburse-ment

Dollars Paid

2016 Q3 Total


1 9 J7189

COAGULATION FACTOR VIIA,RECOMB

(NOVOSEVEN®)

$243,319 66.2% 230.9% $8,759,469 36

2 4 J7181

FACTOR XIII A-SUBUNIT,RECOMB

(TRETTEN®)

$135,505 -0.6% 18.5% $271,010 2

3 N/A J7199 FACTOR IX RECOM,ALBUMIN

FUSION (INDELVION®)1

$130,230 N/A N/A $130,230 1

4 1 J1322 ELOSULFASE ALFA $108,404 -34.7% -66.0% $542,022 5

5 8 J1743 IDURSULFASE $97,679 -0.4% 23.3% $781,431 8

6 3 J7201 FACTOR IX REC, FC FUSION

PROTN (ALPROLIX®) $88,492 -26.0% -28.5% $442,458 5

7 17 J7185 ANTIHEMOPH.FVIII,B-

DOMAIN DEL (XYNTHA®) $85,157 26.5% 84.4% $425,785 5

8 6 J1458 GALSULFASE $78,122 -27.6% -17.0% $390,611 5

9 N/A J7193 FACTOR IX (ALPHANINE® SD, MONONINE®)

2

$74,290 N/A N/A $74,290 1

10 20 J1786 IMIGLUCERASE $59,512 10.7% 88.6% $119,025 2

11 5 Q9975 ANTIHEMOPH.FVIII REC,FC

FUSION (ELOCTATE®) $58,980 0.4% -48.2% $530,824 9

12 15 J0221 ALGLUCOSIDASE ALFA $56,673 -27.3% 16.2% $170,020 3

13 14 J9019 ASPARAGINASE (ERWINIA CHRYSAN)

$55,967 -25.2% 10.7% $1,343,214 24

14 10 J1300 ECULIZUMAB $51,599 -17.7% -28.5% $1,393,173 27

15 N/A C9449 BLINATUMOMAB3 $49,860 55.9% N/A $99,721 2

16 13 J0180 AGALSIDASE BETA $36,709 -12.9% -39.6% $183,544 5

17 N/A J9307 PRALATREXATE4 $36,478 -66.2% N/A $72,957 2

18 26 J7195 FACTOR IX HUMAN

RECOMBINANT (BENEFIX®) $34,253 78.2% 45.4% $137,013 4

19 N/A J9027 CLOFARABINE5 $34,174 17.5% N/A $34,174 1

20 31 J3385 VELAGLUCERASE ALFA $32,599 -28.9% 76.7% $32,599 1

1This drug was approved in 2016 and was added as a Medi-Cal benefit effective for dates of service on or after April 1, 2016.

2This drug only had one utilizing beneficiary in 2016 Q3, and none in 2016 Q2 or 2015 Q3.

3This drug only had two utilizing beneficiaries in 2016 Q3 and 2016 Q2, and none in 2015 Q3.

4This drug only had two utilizing beneficiaries in 2016 Q3, one utilizing beneficiary in 2016 Q2, and none in 2015 Q3.

5This drug only had two utilizing beneficiaries in 2016 Q3, one utilizing beneficiary in 2016 Q2, and none in 2015 Q3.

Version 1.0: Last updated January 17, 2017 1

PROSPECTIVE DUR REVIEW DATE OF REVIEW: January 17, 2017 FIRST DATABANK DRUG THERAPEUTIC CATEGORIES:

ANALGESICS, NARCOTICS

ANTIHYPERGLY,INSULIN,LONG ACT-GLP-1 RECEPT.AGONIST

ANTIMIGRAINE PREPARATIONS

ERYTHROPOIESIS-STIMULATING AGENTS

GENERAL ANESTHETICS,INJECTABLE

INTRA-UTERINE DEVICES (IUDS)

NSAID AND TOPICAL IRRITANT COUNTER-IRRITANT COMB.

NSAIDS, CYCLOOXYGENASE INHIBITOR - TYPE ANALGESICS

TOPICAL ANTI-INFLAMMATORY, NSAIDS

DRUG PROBLEM TYPES: Drug-Allergy (DA), Drug-Pregnancy (PG), Drug-Disease (MC), Therapeutic Duplication (TD), Underutilization (LR), Additive Toxicity (AT), Ingredient Duplication (ID), Drug-Age (PA), High Dose (HD), Low Dose (LD)

BACKGROUND: Each week new Generic Code Number (GCN) sequence numbers are added. Prospective DUR alerts for Overutilization (ER) and Severity Level 1 Drug-Drug Interactions (DD) are automatically turned on for all new GCNs.

ISSUES: New GCNs are reviewed and cross-referenced to the Medi-Cal target drug list for prospective DUR. If a GCN matches a drug on the Medi-Cal target drug list, the prospective DUR alert profile for the existing GCN is used to set the alert profile for the new GCN. A list of new GCNs with alerts turned on other than ER and DD is provided to the DUR Board for review at each DUR Board meeting.

PROPOSED INTERVENTION RECOMMENDATION TO THE DUR BOARD:

Review list of GCNs with prospective DUR alerts turned on between October 1, 2016 and December 31, 2016 (Table 1).

Any DUR Board recommendations for additions, deletions, and/or changes will be submitted to DHCS for review. Status of recommendations will be reported to the DUR Board at DUR Board meetings, as needed.


Table 1. New GCNs for Existing DUR Target Drugs: Q4 2016 (10/01/16 – 12/31/16).

Date GCN Drug Description Additional Alerts Turned on

10/5/2016

076640 MORPHINE SULFATE IN 0.9 % NACL DA, MC, TD, AT, ID, HD, LD

076571 KETOROLAC/NORFLURANE/HFC 245FA

PG 076641

076610 CHORIONIC GONADOTROPIN, HUMAN

10/12/2016 076650 SUMATRIPTAN SUCC/NAPROXEN SOD DA, PG, MC, TD, ID, HD, LD

10/19/2016 076612 LEVONORGESTREL PG, MC, TD, ID, HD, LD

076654 DICLOFENAC SODIUM DA, PG, MC, TD, ID, HD, LD

11/9/2016 076746 DICLOFENAC SODIUM/CAPSAICIN DA, PG, MC, TD, ID, HD, LD

076707 CLOPIDOGREL BISULFATE DA, MC, TD, ID, HD, LD

11/16/2016 075151 MIDAZOLAM HCL/PF PG

11/23/2016 076825 FENOPROFEN CALCIUM, DIHYDRATE PG

11/30/2016 073919 INSULIN DEGLUDEC/LIRAGLUTIDE PG

12/14/2016 076873 KETOROLAC TROMETHAMINE PG

12/21/2016 076904 DICLOFEN SOD/KINESIOLOGY TAPE DA, PG, MC, TD, ID, HD,

12/28/2016 063133

METHOXY PEG-EPOETIN BETA DA, PG, MC, TD, AT, PA, LD 064736

Version 1.0: Last updated January 17, 2017. 1

PROSPECTIVE DUR REVIEW DATE OF REVIEW: January 17, 2017 FIRST DATABANK DRUG THERAPEUTIC CATEGORIES:

Reviewed all drugs.

DRUG PROBLEM TYPE: Clinical Misuse/Additive Toxicity (AT) BACKGROUND: In the current Medi-Cal DUR system, the additive toxicity (AT) alert is generated when a patient reaches a threshold of four active prescriptions for any combination of drugs in specified therapeutic classes. Section 35 of the Medi-Cal DUR Manual specifies that the AT alert should be on for Scheduled pain medications and/or psychotropics. On August 31, 2016, the U.S. Food and Drug Administration (FDA) announced that it will require class-wide changes to drug labeling, including patient information, to help inform health care providers and patients of the serious risks associated with the use of certain opioid medications in combination with benzodiazepines and other central nervous system (CNS) depressants. At the November 15, 2016 DUR Board meeting, it was suggested that by updating the AT alert to focus on opioids, benzodiazepines, and other CNS depressants, the AT alert could be an effective tool to help providers identify patients who may be at high-risk for serious adverse events. ISSUES: A review of the DUR manual shows the reference material for the AT alert listed in Section 20 (DUR: Prospective Drug Use Review) does not contain a complete list of the drugs that have the AT alert turned on at this time. There are also inconsistencies in alert status within drug class and among drug Generic Code Number (GCN) sequence numbers. Further, several drugs identified as Scheduled pain medications and/or psychotropics do not have the AT alert turned on. REVIEW OF CURRENT MEDI-CAL FEE-FOR-SERVICE PROSPECTIVE DUR CRITERIA:

Table 1. Summary of all drugs to review for the AT Alert

Drug Name On List from

FDA On Target Drug List

On AT Target Drug List

DUR Alert Status

Recommendation

ALFENTANIL Y Turn on (all GCNs)

ALPRAZOLAM Y Y Turn on (all GCNs)

AMITRIPTYLINE Y Y ON Keep on (all GCNs)

ARIPIPRAZOLE Y Y Y ON Keep on (all GCNs)

ASENAPINE Y Y Y ON Keep on (all GCNs)

BACLOFEN Y Turn on (all GCNs)

BUPRENORPHINE Y Turn on (all GCNs)

BUPROPION Turn on (all GCNs)

BUSPIRONE Y Y ON Keep on (all GCNs)

BUTABARBITAL Y Y Turn on (all GCNs)

BUTORPHANOL Y Turn on (all GCNs)

CARIPRAZINE Y ON Keep on (all GCNs)





DUR Alert Status

Recommendation

CARISOPRODOL Y Turn on (all GCNs)

CHLORDIAZEPOXIDE Y Y Turn on (all GCNs)

CHLORPROMAZINE Y Y Y ON Keep on (all GCNs)

CHLORPROTHIXENE ON Turn OFF

CHLORZOXAZONE Y Turn on (all GCNs)

CITALOPRAM ON Keep on (all GCNs)

CLOBAZAM Y Turn on (all GCNs)

CLOMIPRAMINE ON Keep on (all GCNs)

CLONAZEPAM Y Y Y ON Keep on (all GCNs)

CLORAZEPATE Y Turn on (all GCNs)

CLOZAPINE Y Y Y ON Keep on (all GCNs)

CODEINE Y Y Y ON Keep on (all GCNs)

CYCLOBENZAPRINE Y Turn on (all GCNs)

DANTROLENE Y Turn on (all GCNs)

DESIPRAMINE ON Keep on (all GCNs)

DESVENLAFAXINE ON Keep on (all GCNs)

DIAZEPAM Y Y Turn on (all GCNs)

DIHYDROCODEINE Y Turn on (all GCNs)

DOXEPIN ON Keep on (all GCNs)

DROPERIDOL ON Turn OFF

DULOXETINE ON Keep on (all GCNs)

ESCITALOPRAM ON Keep on (all GCNs)

ESTAZOLAM Y Y Turn on (all GCNs)

ESZOPICLONE Y Turn on (all GCNs)

FENTANYL Y Y Y ON Keep on (all GCNs)

FLUOXETINE Y Y ON Keep on (all GCNs)

FLUPHENAZINE Y Y Y ON Keep on (all GCNs)

FLURAZEPAM Y Y Y ON Keep on (all GCNs)

FLUVOXAMINE ON Keep on (all GCNs)

HALOPERIDOL Y Y Y ON Keep on (all GCNs)

HYDROCODONE Y Turn on (all GCNs)

HYDROMORPHONE Y Turn on (all GCNs)

ILOPERIDONE Y Y Y ON Keep on (all GCNs)

IMIPRAMINE Y Y ON Keep on (all GCNs)

LEVOMILNACIPRAN ON Keep on (all GCNs)

LITHIUM Y Y ON Keep on (all GCNs)

LORAZEPAM Y Y Turn on (all GCNs)

LOXAPINE Y Y Y ON Keep on (all GCNs)

LURASIDONE Y Y Y ON Keep on (all GCNs)

MEPERIDINE Y Turn on (all GCNs)

MESORIDAZINE ON Turn OFF

METAXALONE Y Turn on (all GCNs)

METHADONE Y Turn on (all GCNs)

METHOCARBAMOL Y Turn on (all GCNs)

METHOTRIMEPRAZINE ON Turn OFF

METHOXY PEG-EPOETIN BETA

ON Turn OFF

MIRTAZAPINE ON Keep on (all GCNs)

MOLINDONE Y ON Keep on (all GCNs)

MORPHINE Y Y Y ON Keep on (all GCNs)

NORTRIPTYLINE Y Y ON Keep on (all GCNs)

OLANZAPINE Y Y Y ON Keep on (all GCNs)

ORPHENADRINE Y Turn on (all GCNs)

OXAZEPAM Y Y Turn on (all GCNs)

OXYCODONE Y Y Y ON Keep on (all GCNs)

OXYMORPHONE Y Turn on (all GCNs)

PALIPERIDONE Y Y Y ON Keep on (all GCNs)





DUR Alert Status

Recommendation

PAROXETINE Y Y ON Keep on (all GCNs)

PENTAZOCINE Y Turn on (all GCNs)

PENTOBARBITAL Y Y Turn on (all GCNs)

PERPHENAZINE Y Y Y ON Keep on (all GCNs)

PHENOBARBITAL Y Y ON Keep on (all GCNs)

PIMAVANSERIN Y ON Keep on (all GCNs)

PIMOZIDE Y Y ON Keep on (all GCNs)

PROMAZINE ON Turn OFF

QUAZEPAM Y Turn on (all GCNs)

QUETIAPINE Y Y Y ON Keep on (all GCNs)

RAMELTEON Y Turn on (all GCNs)

REMIFENTANIL Y Turn on (all GCNs)

RISPERIDONE Y Y Y ON Keep on (all GCNs)

SECOBARBITAL Y Y Turn on (all GCNs)

SERTRALINE ON Keep on (all GCNs)

SUFENTANIL Y Turn on (all GCNs)

SUVOREXANT Y Turn on (all GCNs)

TAPENTADOL Y Turn on (all GCNs)

TEMAZEPAM Y Y Y ON Keep on (all GCNs)

TESTOSTERONE Y Y ON Turn OFF

THIORIDAZINE Y Y Y ON Keep on (all GCNs)

THIOTHIXENE Y Y Y ON Keep on (all GCNs)

TIZANIDINE Y Turn on (all GCNs)

TRAMADOL Y Y Y ON Keep on (all GCNs)

TRAZODONE Y Y ON Keep on (all GCNs)

TRIAZOLAM Y Y Y ON Keep on (all GCNs)

TRIFLUOPERAZINE Y Y Y ON Keep on (all GCNs)

VENLAFAXINE Turn on (all GCNs)

VILAZODONE ON Keep on (all GCNs)

VORTIOXETINE ON Keep on (all GCNs)

ZALEPLON Y Turn on (all GCNs)

ZIPRASIDONE Y Y Y ON Keep on (all GCNs)

ZOLPIDEM Y Y Y ON Keep on (all GCNs)

Table 2. Recommend turning on AT alert (drugs on list provided by FDA). Drug Name FDA Drug Category Drug Name FDA Drug Category

ALPRAZOLAM

BENZODIAZEPINES

ALFENTANIL

OPIOID PAIN OR COUGH MEDICATIONS

CHLORDIAZEPOXIDE BUPRENORPHINE

CLOBAZAM BUTORPHANOL

CLORAZEPATE DIHYDROCODEINE

DIAZEPAM HYDROCODONE

ESTAZOLAM HYDROMORPHONE

LORAZEPAM MEPERIDINE

OXAZEPAM METHADONE

QUAZEPAM OXYMORPHONE

BACLOFEN

MUSCLE RELAXANTS

PENTAZOCINE

CARISOPRODOL REMIFENTANIL

CHLORZOXAZONE SUFENTANIL

CYCLOBENZAPRINE TAPENTADOL

DANTROLENE BUTABARBITAL

OTHER SLEEP DRUGS AND TRANQUILIZERS

METAXALONE ESZOPICLONE

METHOCARBAMOL PENTOBARBITAL

ORPHENADRINE RAMELTEON

TIZANIDINE SECOBARBITAL

SUVOREXANT

ZALEPLON


Table 3. Recommend keeping on (or turning on) AT alert, even though not on FDA list. Drug Name

AMITRIPTYLINE FLUOXETINE PHENOBARBITAL

BUSPIRONE FLUVOXAMINE PIMOZIDE

BUTALBITAL IMIPRAMINE PROTRIPTYLINE

BREXPIPRAZOLE LEVOMILNACIPRAN SERTRALINE

CITALOPRAM LITHIUM SODIUM OXYBATE

CLOMIPRAMINE LEVORPHANOL TRAZODONE

DESIPRAMINE MIDAZOLAM VENLAFAXINE

DESVENLAFAXINE MIRTAZAPINE VILAZODONE

DOXEPIN NEFAZODONE VORTIOXETINE

DULOXETINE NORTRIPTYLINE

ESCITALOPRAM PAROXETINE

Table 4. Recommend turning off AT alert. Drug Name

CHLORPROTHIXENE METHOTRIMEPRAZINE TESTOSTERONE

DROPERIDOL METHOXY PEG-EPOETIN BETA

MESORIDAZINE PROMAZINE

Table 5. Summary of Paid Claims for Drugs on the Medi-Cal List of Contract Drugs

(between September 1, 2016 and November 30, 2016). Total Utilizing Beneficiaries with a Paid Claim

Drug Name Total Paid

Claims Total Utilizing

Beneficiaries (n) One Drug

Only (n; %) Four or More Drugs (n; %)

AMITRIPTYLINE 3,456 2,311 1,187; 51% 333; 14%

ARIPIPRAZOLE 81,979 36,687 26,710; 73% 391; 1%

ASENAPINE 4,326 1,888 1,067; 57% 110; 6%

BACLOFEN 12,640 7,407 3,339; 45% 0; 0%

BUPRENORPHINE 1,898 1,300 1,057; 81% 14; 1%

BUPROPION 6,362 3,646 1,319; 36% 248; 7%

BUSPIRONE 3,165 1,943 423; 22% 267; 14%

CHLORPROMAZINE 5,470 2,082 714; 34% 402; 19%

CLOMIPRAMINE 118 58 16; 28% 15; 26%

CLONAZEPAM 6,635 3,425 851; 25% 62; 2%

CLOZAPINE 15,875 2,817 1,363; 48% 0; 0%

CODEINE 25,346 20,812 17,291; 83% 996; 5%

DANTROLENE 273 98 18; 18% 40; 41%

DESIPRAMINE 48 27 15; 56%

DIAZEPAM 2,381 1,667 665; 40% 0; 0%

DOXEPIN 361 222 80; 36% 12; 5%

DULOXETINE 3,643 1,997 693; 35% 359; 18%

ESCITALOPRAM 7,749 4,412 1,915; 43% 990; 22%

FENTANYL 586 286 55; 19%

FLUOXETINE 9,791 5,557 2,892; 52% 586; 11%

FLUPHENAZINE 2,644 1,018 377; 37% 119; 12%

FLURAZEPAM 85 43 14; 33% 13; 30%

FLUVOXAMINE 359 168 59; 35% 37; 22%

HALOPERIDOL 20,796 8,084 3,215; 40% 175; 2%

HYDROCODONE 36,395 31,400 24,617; 78% 1,848; 6%

HYDROMORPHONE 1,292 758 237; 31% 192; 25%

ILOPERIDONE 1,872 653 371; 57%

IMIPRAMINE 348 189 116; 61% 13; 7%

LITHIUM 28,354 12,363 4,146; 34% 1,451; 12%

LORAZEPAM 8,660 6,079 2,263; 37% 22; 0%

LOXAPINE 1,069 384 144; 38% 42; 11%

LURASIDONE 34,513 15,051 9,609; 64% 491; 3%

MEPERIDINE


Total Utilizing Beneficiaries with a Paid Claim

Drug Name Total Paid

Claims Drug Name

Total Paid Claims

Drug Name

MIRTAZAPINE 4,035 2,166 710; 33% 104; 5%

MORPHINE 1,288 681 153; 22% 201; 30%

NORTRIPTYLINE 1,079 736 406; 55% 90; 12%

OLANZAPINE 69,901 27,047 17,038; 63% 75; 0%

OXYCODONE 9,238 6,573 3,892; 59% 857; 13%

PAROXETINE 4,161 2,565 1,324; 52% 281; 11%

PERPHENAZINE 3,544 1,428 691; 49% 49; 3%

PHENOBARBITAL 2,428 952 594; 62% 70; 7%

PROTRIPTYLINE

QUETIAPINE 128,227 50,462 34,333; 68% 3,705; 7%

RISPERIDONE 72,509 29,229 19,703; 67% 280; 1%

SERTRALINE 14,316 8,366 4,399; 53% 922; 11%

TEMAZEPAM 1,652 960 208; 22% 29; 3%

THIORIDAZINE 710 270 157; 58% 15; 6%

THIOTHIXENE 1,050 389 183; 47%

TRAMADOL 12,179 9,458 5,638; 60% 261; 3%

TRAZODONE 10,831 6,409 1,756; 27% 767; 12%

TRIAZOLAM 80 51 19; 37%

TRIFLUOPERAZINE 1,062 426 236; 55% 56; 13%

VENLAFAXINE 3,697 1,979 734; 37% 360; 18%

VORTIOXETINE 231 132 44; 33% 43; 33%

ZIPRASIDONE 17,949 6,866 4,219; 61% 335; 5%

ZOLPIDEM 4,168 2,565 784; 31% 736; 29% *Cells with less than 10 utilizing beneficiaries have been blacked out.

Paid claims with an approved Treatment Authorization Request (TAR) on file were excluded from the summary data listed in Table 5 in order to better model the alert burden. Any drug with an approved TAR on file will not trigger DUR alerts. As implemented, the AT alert will have fewer alerts than shown in the summary data, as the date of service and days’ supply for at least four drugs must overlap to trigger the AT alert, while the summary data was created using parameters of at least one paid claim (of any days’ supply) of at least four separate drugs within a 90-day window. Of the 24 drugs in which over 10% of utilizing beneficiaries have paid claims for at least four drugs on the list (shown in italicized and bold print), 14 of these drugs are not on the current list of drugs provided by the FDA. PROPOSED INTERVENTION RECOMMENDATION TO THE DUR BOARD:

Review the tables of drugs and consider each of the following recommendations: o Turn on or keep on the AT alert for all drugs on the list provided by the FDA

(Table 2). o Keep on the AT alert for current drugs on with the AT alert on that are considered

either Scheduled pain or psychotropic medications, regardless of whether they appear on the list provided by the FDA (Table 3). However, a review of claims data (Table 5) show these drugs are more likely to trigger the AT alert.

o Turn off the AT alert for drugs either not approved by the FDA, drugs taken off the market in the United States, and/or all drugs not on the list provided by the FDA nor Scheduled pain or psychotropic medications (Table 4).

Update drug alert profiles for consistency across all GCNs, as needed.

Update the DUR manual and alert profiles, as needed, to reflect that the AT alert now reviews all opioid pain or cough medications, benzodiazepines, muscle relaxants, psychotropic medications, and other sleep drugs and tranquilizers.

Re-evaluate the AT alert data after changes have been implemented for at least a 90-day period, in order to review alert burden.

Version 2.1: Last modified January 30, 2017 1

DUR EDUCATIONAL OUTREACH TO PROVIDERS

UPDATE: METABOLIC TESTING IN CHILDREN AND ADOLESCENTS LETTER - 2016

DATE OF MAILING: November 11, 2016 and January 30, 2017

DATE OF UPDATE: October 26, 2016 and January 30, 2017

BACKGROUND

Effective October 1, 2014, any use of antipsychotics for Medi-Cal beneficiaries 0 – 17 years

of age requires an approved Treatment Authorization Request (TAR). A report on the

impact of this policy was presented to the DUR Board at the September 20, 2016 DUR

Board meeting. At that meeting, the DUR Board recommended DUR educational outreach

to providers regarding metabolic monitoring for children and adolescents using antipsychotic

medications, using methods similar to the mailing conducted in August 2015.

OBJECTIVES

To improve metabolic monitoring rates among children and adolescents in the Medi-

Cal fee-for-service population with ≥ 4 paid claims for an antipsychotic medication

between January 1, 2015 and September 30, 2016

METHODS

The study population identified when writing the policy impact report was used to identify

Medi-Cal fee-for-service (FFS) beneficiaries in need of metabolic testing. This initial study

population was comprised of a total of 2,272 children and adolescents who met the following

criteria:

Between 1 and 17 years of age (between January 1, 2015 and December 31, 2015)

Had at least two paid claims for an antipsychotic medication between January 1,

2015 and December 31, 2015

Did not have a paid claim for either a HbA1C/glucose or LDL-C/cholesterol test

between January 1, 2015 and December 31, 2015

For the mailing, eligibility criteria was re-reviewed for each of these beneficiaries to ensure

they remained continuously enrolled in the Medi-Cal fee-for-service program between

January 1, 2016 (the day after the original data pull for the DUR educational bulletin) and

September 30, 2016.

Further inclusion/exclusion criteria for beneficiaries to be included in the study population:

Beneficiaries < 18 years of age through November 30, 2016


Beneficiaries with ≥ 2 paid claims for an antipsychotic medication between January

1, 2016 and September 30, 2016 (≥ 4 paid claims total between January 1, 2015 and

September 30, 2016)

Beneficiaries currently taking an antipsychotic medication (a paid claim with a days

supply extending past July 31, 2016)

Did not have a paid claim for either an HbA1C/glucose or LDL-C/cholesterol test

between January 1, 2015 and September 30, 2016

Patient/prescriber combinations were excluded if they were already mailed letters in

2015 and a patient survey was received by the DUR program

A total of 578 beneficiaries from the original cohort of 2,272 met the above inclusion/

exclusion criteria. There were two cases where a beneficiary had two prescribers

prescribing different medications concurrently so both prescribers were included in the

mailing. Twenty-five patient/prescriber combinations were included in the 2015 mailing and

had surveys received, although only 24 were excluded for this mailing, as one survey stated

that that prescriber had no knowledge of the patient. Eleven additional prescriptions were

filled from that prescriber since the 2015 mailing, so this patient/prescriber combination was

included again. A total of 361 prescribers were identified for educational outreach letters.

Prescribers were mailed a letter with a summary of clinical recommendations. The mailing

included the following:

List of patients (name and date of birth) from the study population linked to this

prescriber

Medi-Cal DUR article on appropriate antipsychotic medication use among children

and adolescents

Provider response survey(s); one survey per patient

Timeframe of mailing following approval of packet by DHCS:

Prescriber Letters (n=361)

o October 25, 2016: packet submitted to Publications

o October 31, 2016: final, edited packet approved by DHCS

o November 11, 2016: packets printed

o November 11, 2016: packet mailed to providers

OUTCOMES

Direct costs associated with mailing:

o A total of 361 letters were mailed for a total estimated direct cost of $360.67

o Each letter was estimated to have a direct cost of $0.9991, which equals the

cost of two envelopes and postage for two envelopes, as a self-addressed

stamped envelope was included with each letter

Rate of undeliverable letters (within 90 days): o A total of 77 prescribers (out of 361 unique prescribers) had their letters

returned to sender as undeliverable, for an undeliverable rate of 21%.


o A total of 67 undeliverable letters were re-sent to different addresses on January 30, 2017. Undeliverable rate and provider response rate will be updated for these letters 90 days after the re-mailing.

Provider response rate (within 90 days): o A total of 93 prescribers (out of 361 unique prescribers) returned 173 patient

surveys, for a provider response rate of 26%. o If undeliverable letters are removed from the denominator, the response rate

increases to 33% (93 out of 284 unique prescribers) o The 173 patient surveys received thus far represent 30% of patient profiles in

this mailing Survey responses (n=173)

A total of 153 surveys (88%) indicated that the patient was currently under their care, with the following responses (respondents could check more than one option):

o “I have reviewed the information and will order metabolic testing” (n=105; 61%)

o “I have reviewed the information and will continue without change” (n=40; 23%)

o “however, has not seen me recently” (n=8; 5%)

A total of 20 surveys (12%) indicated that the patient was not currently under their care, with the following responses:

o “but has previously been a patient of mine” (n=14; 8%) o “however, I did prescribe medication while covering for other MD or in the

ER” (n=5; 3%) o “and has never been a patient of mine” (n=1; 1%)

A total of 79 patient surveys (46%) contained written comments from providers. o The majority of comments discussed lab testing recently completed or

ordered As stated in the original proposal, the following outcome variables will need to be assessed

at later time points, as medical claims data become available:

The primary outcome variable will be whether or not the beneficiary has a laboratory

test for HbA1C/glucose and/or LDL-C/cholesterol within 90 days of the mailing of the

intervention letter.

The secondary outcome variable will be the percentage of patients with additional

paid claims for antipsychotic medications within 6 months following the mailing of the

intervention letter (stratified by laboratory monitoring status).


DUR EDUCATIONAL OUTREACH TO PROVIDERS

UPDATE: BUPRENORPHINE LETTER

DATE OF MAILING: November 11, 2016 and January 30, 2017

DATE OF UPDATE: November 14, 2016 and January 30, 2017

BACKGROUND

Buprenorphine, both by itself and in combination with naloxone, has emerged as a first-line

treatment for opioid addiction. Several reviews have concluded there is high-quality

evidence to show that medication-assisted treatment with buprenorphine is effective in the

maintenance treatment of opioid addiction and increases retention in treatment. Despite this

success, buprenorphine treatment is highly underutilized and access is often restricted.

Recent efforts at the national level have expanded access and removed restrictions to

buprenorphine, including increasing the number of patients that providers are able to treat

under the DATA 2000 waiver. As of August 8, 2016, qualified prescribers may now treat up

to 275 patients.

A recent analysis by the Medi-Cal Drug Use Review (DUR) program found that 47% of

Medi-Cal fee-for-service beneficiaries with a paid claim for buprenorphine in the past year

continue to be adherent to their treatment regimen. Concomitant use of any opioid among

beneficiaries with at least one paid claim for buprenorphine was also very low (3%), and

even lower among the adherent group (2%).

OBJECTIVES

To inform providers that buprenorphine use among Medi-Cal fee-for-service

beneficiaries is associated with high adherence rates and decreased concomitant

use of high-risk medications, including other opioids

To increase the number of Medi-Cal patients receiving treatment with buprenorphine

To increase the number of Medi-Cal providers able to provide buprenorphine

treatment

METHODS

The top prescribers (by total quantity prescribed) of opioids in the Medi-Cal fee-for-service

program between October 1, 2015 and September 30, 2016 were cross-referenced to the

list of California providers with a current waiver to provide buprenorphine treatment. A total

of 100 of the top prescribers of opioids without a current buprenorphine waiver were sent a

letter with more information about buprenorphine training.


The mailing also included the following:

Medi-Cal DUR article on buprenorphine

Provider response survey for each provider

In addition, the top 100 prescribers (by total number of patients) of buprenorphine in the

Medi-Cal program between October 1, 2015 and September 30, 2016 were sent a letter

thanking them for obtaining the waiver and letting them know that the maximum number of

patients that qualified providers can treat has been raised to 275. The mailing also included

the following:

Medi-Cal DUR article on buprenorphine

Provider response survey for each provider

Timeframe of mailing following approval of packet by DHCS:

Top Opioid Prescriber Letters (n=100) and Top Buprenorphine Prescriber Letters

(n=100)

o October 25, 2016: packet submitted to Publications

o November 1, 2016: final, edited packet approved by DHCS

o November 9, 2016: packet sent to printer

o November 11, 2016: packet mailed to providers

OUTCOMES

Direct costs associated with mailing: o A total of 200 letters were mailed for a total estimated direct cost of $199.82 o Each letter was estimated to have a direct cost of $0.9991, which equals the

cost of two envelopes and postage for two envelopes, as a self-addressed stamped envelope was included with each letter

Rate of undeliverable letters (within 90 days): o A total of 26 prescribers (out of 200 unique prescribers) had their letters

returned to sender as undeliverable, for an undeliverable rate of 13%. o A total of 24 undeliverable letters were re-sent to different addresses on

January 30, 2017. Undeliverable rate and provider response rate will be updated for these letters 90 days after the re-mailing.

Provider response rate (within 90 days): o A total of 37 prescribers (out of 200 unique prescribers) returned surveys, for

a provider response rate of 19%. o If undeliverable letters are removed from the denominator, the response rate

increases to 21% (37 out of 174 unique prescribers) Survey responses (n=37)

A total of 20 surveys (54%) indicated that the provider found the mailing very useful

A total of 13 surveys (35%) indicated that the provider found the mailing somewhat useful

A total of 3 surveys (8%) indicated that the provider did not find the mailing useful

Five providers requested a phone call from the DUR pharmacist on the survey. All were contacted and two of these providers offered to help the DUR program with their buprenorphine expertise, including providing policy suggestions on how to expand access to buprenorphine.


Written comments from top opioid prescribers (n=8)

Our patients haven't misused opioids

Have a Medi-Cal/state-sponsored chronic pain clinic

Does Medi-Cal pay for telemedicine?

I just substitute for other provider groups at this point; would be helpful to see how my prescribing compares to statewide provider data

I recently took the training and have been licensed to prescribe Suboxone and buprenorphine.

Would like more information on opiate dependency.

I’m already waivered.

I am an oncologist/hematologist taking care of very sick cancer and sickle-cell patients that are in constant, severe pain. Is there utility in use of buprenophine in this patient population? I found this information to be very helpful and useful. Thank you!

Written comments from top buprenorphine prescribers (n=14)

As a regular AATOD attendee and ABAM-certified physician i have ample exposure to buprenorphine resources. It is nice to see the emphasis upon respectful treatment of our patients by pharmacists and other treatment providers.

Thank you

When will NPs be allowed to prescribe buprenorphine per data 2000?

I am a retired physician who came back to treat only opioid addicts. Medi-Cal reimbursement is so low that if my partners did not give me a free office and paid secretary and medical assistant I could not continue to treat your patients. No younger doctor in private practice will treat Medi-Cal patients unless fee-for-serivce fees increase!

Is there more advanced training beyond the 8 hour course?

Some of pharmacists are reluctant filling Suboxone prescriptions. They say, "You write too many Suboxone prescriptions." If you can, send information about safety of filling prescriptions.”

I am uneasy when a patient is taking a benzodiazepine concurrently with buprenorphine. So I am recommending that patients taper from benzodiazepines if they wish to continue with buprenorphine. I would greatly appreciate any information you can supply with details about the safety or danger of the benzo/Suboxone combination. Also, more detailed information regarding treatment guidelines for benzos and Suboxone would be helpful.

Thanks for your support for opioid dependent patients and the waivered physicians.

I do not agree with maximum dose of 32 mg/day; this is a very high dose and is not needed. 16 mg/day should be fine. Even during escalation the maximum is 24 mg/day!!!

Some pharmacies do not know how to process medical claims and take 3 days to get Suboxone.

Work with Congress to eliminate the need for a special license to prescribe buprenorphine. This is a barrier to more widespread use by doctors. Why should doctors be able to prescribe unlimited quantities of other more dangerous opioids without a special license, yet require a waiver to prescribe much safer, life-saving buprenorphine?

I could teach a class if you needed.


I’m very interested in cost ($160 for 30 Subutex tablets is a ripoff) and also regarding doses, I’d like to see the mean, standard deviation, median. Finally, when will buprenorphine be available in a MAT clinic with licensed NPs? My 100 patient average 14.2 mg/day with a range of 0.5 to 24 mg with one outlier at 32 mg (an engineer who is doing great!)

Refer providers to other resources: www.pcssmat.org to obtain a mentor, www.aoaam.org for free half and half training courses. There are other organizations sponsoring training: APA, AAAP, ASAM. In addition to pharmacists being welcoming and compassionate, pharmacy techs and other personnel also need education and attitude adjustment if needed. 1st person patient narratives can be helpful to educate all concerned. Understanding addiction as a chronic disease, especially the behavioral aspects that elicit counter transference. Should be a part of provider and employee education. Medi-Cal is the best insurer of all for buprenorphine treatments. Thank you!!! One question to clarify/modify: where you say in your article "prescriptions less than 30 days" you should change to “less than 28 days" to allow greater accountability for patients to prescribers. 30 days for returning in 4 weeks provides 2 extra days and permits stockpiling medications, possible diversion.

As stated in the original proposal, the following outcome variables will need to be assessed

at later time points, as medical claims data become available:

The primary outcome variable will be the percentage increase in the number of

patients (all of Medi-Cal) with paid claims for buprenorphine among all providers who

received the mailing, calculated one year prior to and one year after the mailing of

the letter.

The following secondary outcome variables will also be assessed after one year:

o The number of providers contacted who complete the training and applied for

a waiver

o Percentage change (by total quantity prescribed) of total opioid prescribing in

the Medi-Cal fee-for-service population, by individual provider among

providers contacted.


DUR EDUCATIONAL OUTREACH TO PROVIDERS UPDATE: ASTHMA LETTER

DATE OF MAILING: Scheduled for February 15, 2017 DATE OF UPDATE: January 30, 2017 OBJECTIVES

To improve the quality of asthma care in the Medi-Cal fee-for-service (FFS) population.

METHODS Pharmacy and medical claims were used to identify Medi-Cal FFS beneficiaries with 1) at least four or more dispensing events for asthma rescue medications in 2016 2) no paid claims for an outpatient visit in which asthma was one of the listed diagnoses between October 1, 2015 and January 31, 2017; and 3) an asthma medication ratio (AMR) < 0.50 during the measurement year. Further inclusion criteria for the educational DUR educational outreach to providers included the following:

Continuous eligibility in Medi-Cal FFS between October 1, 2015 and January 31, 2017 (16 months prior to the mailing)

A paid claim for an asthma medication between November 1, 2016 and January 31, 2017 (90 days prior to the mailing)

Further exclusion criteria for the educational DUR educational outreach to providers included the following:

Co-morbid medical conditions beyond those listed in the HEDIS criteria that may impair lung function and breathing ability (includes congenital quadriplegia, pulmonary embolism, muscular dystrophy, spina bifida) and/or beneficiaries with breathing and/or feeding tubes.

A total of 943 beneficiaries with asthma medications prescribed by 987 different providers met all of the above inclusion/exclusion criteria. Each patient profile will be reviewed by a pharmacist and any additional conditions resulting in medical exclusions will be sent to a physician for final review. Prescribers were mailed a packet including the following:

Letter describing the Medi-Cal DUR article on asthma quality-of-care that included the recommendation to schedule an outpatient visit for each patient profile included with the mailing, in order to evaluate asthma control

List of patients, including patient name, date of birth, history of paid pharmacy claims for asthma rescue and asthma controller medications, history of emergency department visits and inpatient hospitalizations where the primary


diagnosis or secondary diagnosis was listed as asthma (dates of service between January 1, 2016, and December 31, 2016)

Medi-Cal DUR article on asthma quality-of-care

Patient survey (one per patient) Timeframe of each mailing following approval of packet by DHCS:

Asthma Quality-of-Care Letters (n=TBD) o Wednesday, February 1, 2017: packet submitted to Publications o TBD: final, edited packet approved by DHCS/Xerox o TBD: packet sent to printer o Wednesday, February 15, 2017: packet mailed to providers

OUTCOMES

Direct costs associated with mailing are to be determined. The rate of undeliverable packets and the provider response rate will be calculated 90-days after the mailing. Provider survey responses will also be collected and presented in aggregate. The following primary outcome variable will be assessed after 90 days following the packet mailing date in a subgroup of continuously eligible Medi-Cal FFS beneficiaries:

Percentage of beneficiaries with an outpatient visit in which asthma was one of the listed diagnoses

The following secondary outcome variables will be assessed for the 12 months following the packet mailing date in a subgroup of continuously eligible Medi-Cal FFS beneficiaries:

Total reimbursement paid to pharmacies for all asthma-related pharmacy claims

Percentage of beneficiaries with an AMR ≥ 0.50 (among beneficiaries still taking any medication for asthma)

The net change in AMR by individual utilizing beneficiary (among beneficiaries still taking any medication for asthma)

Rate of emergency department visits where the primary diagnosis is asthma

Rate of inpatient hospitalizations where the primary diagnosis is asthma


RETROSPECTIVE DUR REVIEW

DATES OF REVIEW: January 17, 2017

FIRST DATABANK DRUG THERAPEUTIC CATEGORIES:

PROTON-PUMP INHIBITORS

HISTAMINE H2-RECEPTOR INHIBITORS

DRUG PROBLEM TYPES: Over Utilization (OU), Therapeutic Appropriateness (O1)

BACKGROUND: Proton pump inhibitors (PPIs), typically used to reduce gastric acid, are one of the

most commonly prescribed medications in the United States.1,2 However, an estimated 25% to 70% of

these prescriptions have no appropriate indication for PPIs, treatment with PPIs often continues well

beyond recommended guidelines, and there is increasing data showing that PPIs are associated with a

number of adverse effects.2,3 Current evidence now suggests PPI use may be associated with an

increased risk of both acute and chronic kidney disease, hypomagnesemia, Clostridium difficile

infection, osteoporotic fractures, and dementia.1-5 A recent comparative study found an increased risk

of chronic kidney disease specific to long-term use of PPI medications, while finding no increased risk

with long-term use of H2 receptor antagonists, which are prescribed for the same indications as PPIs.4

ISSUES: The United States Food and Drug Administration (FDA) has issued several safety alerts for

PPIs dating back to 2007. While recent pharmacy claims data from the Medi-Cal Fee-for-Service (FFS)

program show that PPIs recently dropped out of the top 20 drug therapeutic categories (by the

percentage of utilizing beneficiaries with a paid claim), PPIs remain one of the top 10 most utilized over-

the-counter medications in the FFS program. At the DUR Board meeting on September 20, 2017, the

DUR Board requested a retrospective DUR review of the entire class of PPIs. For this review, the class

of H2 receptor antagonists was included as well, as both medications work by blocking and decreasing

the production of gastric acid.

REVIEW OF CURRENT MEDI-CAL FEE-FOR-SERVICE (FFS) CRITERIA: Paid claims for all proton

pump inhibitor and H2 antagonist medications with dates of service between November 1, 2015 and

October 31, 2016 were reviewed for Medi-Cal fee-for-service beneficiaries. A review of utilizing

beneficiaries is shown below in Figure 1.


Figure 1. Utilization of proton pump inhibitors and H2 antagonists with dates of service between

November 1, 2015 and October 31, 2016).

As shown in Figure 1, when the date of service restriction was added to omeprazole in April 2016, use

went from approximately 5,000 beneficiaries to close to zero beneficiaries. There was a slight increase

in utilizing beneficiaries with a paid claim for other proton-pump inhibitors and H2 antagonists for the

next two months, but after June 2016, utilization for these drugs went back to previous levels. In order

to account for the shift in the Medi-Cal FFS population and to evaluate the change in utilization data

over time, the change in utilizing beneficiaries was calculated (Table 1).

Table 1. Change in Utilizing Beneficiaries between November 2015 and October 2016.

Utilizing Beneficiaries Change

Nov-15 Oct-16

All Age Groups

ALL PROTON-PUMP INHIBITORS 11,330 6,799 -40.0%

ALL H2 ANTAGONISTS 6,362 5,924 -6.9%

TOTAL UTILIZING BENEFICIARIES 429,675 406,123 -5.5%

65 Years and Older Age Group

ALL PROTON-PUMP INHIBITORS 1,326 599 -54.8%

ALL H2 ANTAGONISTS 513 387 -24.6%

TOTAL UTILIZING BENEFICIARIES 48,403 44,676 -7.7%

Overall use of PPIs decreased by 40% during the measurement year, while the population decreased

by only 6%. Among the 65 years and older age group, the decline was even greater (a decrease of

0

Restriction added to allow only claims with

dates of service through April 30, 2016


55%, compared with a population decrease of 8%). Use of H2 antagonists, by comparison, remained

relatively parallel with the overall decrease in total utilizing beneficiaries (decreases of 7% and 6%,

respectively), but showed a much greater decrease in the 65 years and older population, suggesting

that overall use of these medications is decreasing in this population.

PROPOSED INTERVENTION RECOMMENDATION TO THE DUR BOARD:

Review and discuss the utilization data for the PPI and H2 antagonist medications and

determine if there is a need for further evaluation.

Discuss potential areas within this class of medications that might merit a DUR educational alert

or bulletin, for example, information regarding potential adverse events related to the use of

PPIs, as well as current treatment recommendations. Given the association with kidney disease

and low magnesium levels, rates of serum creatinine and magnesium levels monitoring could be

calculated for FFS beneficiaries.

Discuss potential benefits of DUR educational outreach to providers regarding PPIs. Different

subgroups for consideration could include the following:

o Prescribers with patients 65 years of age and older with paid claims for PPIs

o Prescribers with infant patients with paid claims for PPIs

o High-volume prescribers of PPIs

o Prescribers with patients with > 180 days of paid claims for PPIs and no paid claims for

serum creatinine and magnesium monitoring tests within two years

Continuous monitoring of the utilization of proton-pump inhibitors and other top drug therapeutic

categories is recommended on an ongoing basis, and as requested by the DUR Board.

REFERENCES

1. Schoenfeld AJ and Grady D. Adverse effects associated with proton pump inhibitors. JAMA Intern Med. 2016 Feb;176(2):172-4. 2. Forgacs I and Loganayagam A. Overprescribing proton pump inhibitors. BMJ. 2008;336(7634):2-3. Available at:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2174763/pdf/bmj-336-7634-edit-00002.pdf. Accessed: January 20, 2017. 3. Wilhelm SM, Rjater RG, Kale-Pradhan PB. Perils and pitfalls of long-term effects of proton pump inhibitors. Expert Rev Clin

Pharmacol. 2013;6(4):443-451. 4. Lazarus B, Chen Y, Wilson FP, et al. Proton pump inhibitor use and the risk of chronic kidney disease. JAMA Intern Med.

2016;176(2):238-246. 5. Gomm W, von Holt K, Thomé F, et al. Association of proton pump inhibitors with risk of dementia: a pharmacoepidemiological

claims data analysis. JAMA Neurol. 2016 Apr;73(4):410-6.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2174763/pdf/bmj-336-7634-edit-00002.pdf

Update: DUR Publications

February 21, 2017

Shal Lynch, PharmD, CGP Health Sciences Associate Clinical Professor Department of Clinical Pharmacy School of Pharmacy

February 2016: DUR Educational Bulletin (1)

Learning Objectives

• Review the FDA labeling changes for fluoroquinolones, including the updated Boxed Warning

• Describe potential adverse effects associated with use of fluoroquinolones

• Summarize best practices for responsible prescribing of fluoroquinolones

Clinical Review: Fluoroquinolones

02/21/2017 Update: DUR Publications 2


Background

• Fluoroquinolones are a class of broad-spectrum antibiotics, which include ciprofloxacin and levofloxacin

• Important for treatment of serious infections, especially those that are hospital acquired and when resistance to other agents is suspected

• The Infectious Diseases Society of America, the American Thoracic Society, and other professional organizations recommend fluoroquinolones not be used as first-line therapy




FDA News Release – July 26, 2016

• Labeling changes to enhance warnings of disabling and potentially permanent adverse effects associated with fluoroquinolone use

• Risks of fluoroquinolones generally outweigh the benefits for patients with acute sinusitis, acute bronchitis, and uncomplicated urinary tract infections

• Adverse effects may include tendinitis, tendon rupture, peripheral neuropathy, confusion, and hallucinations






Use of fluoroquinolones in the Medi-Cal Fee-for-Service population

• A total of 50,843 beneficiaries had least one paid pharmacy claim for a fluoroquinolone medication between December 1, 2015 and November 30, 2016

• Medical claims were reviewed to determine if the indication was either acute sinusitis (19%), acute bronchitis (10%), or uncomplicated urinary tract infections (39%)

• Approximately 68% of fluoroquinolone use during the measurement year appeared to be potentially inappropriate based on the new FDA recommendations




Clinical Recommendations

• Providers should not prescribe systemic fluoroquinolones to patients who have other treatment options for acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, and uncomplicated urinary tract infections

• Discontinue the fluoroquinolone treatment immediately at the first signs or symptoms of any serious adverse reaction

• Avoid fluoroquinolones in patients who have previously experienced serious adverse reactions associated with fluoroquinolones

Future Topics: Bulletins

Summarize relative risk of QT interval prolongation due to adverse drug reactions (in-progress)

Describe recent FDA labeling changes for opioids and other CNS depressants, including an evaluation of high-risk drug use in the Medi-Cal population

Provide treatment guidelines for managing pain in population with co-morbid mental health conditions, including those with a documented history of substance abuse

Nicotine replacement therapy – to be timed with implementation of pharmacist furnishing of NRT

Topics from today’s meeting: Proton-pump inhibitors

DUR Educational Bulletins:


Future Topics: Alerts/Prospective Reviews

DUR Educational Alerts:

Annual vaccine alert, including any updates on current guidelines (ongoing, published each September)

FDA drug safety communications for drugs on the Medi-Cal List of Contract Drugs (ongoing)

Prospective DUR Reviews:

Top DUR alerts by volume (in-progress for May 2017 meeting)

Annual review of categories for duplicate therapy (Section 25, ongoing)

Discrepancy clean-up (Section 20, ongoing)

Quarterly review of new GCNs (ongoing, quarterly)

Updated therapeutic duplication alert, once implemented

Updated pregnancy alert, once implemented


Future Topics: Retrospective Reviews

Retrospective DUR Reviews:

Hormonal contraceptives, specifically in the pharmacy setting

Assessment of opioid use and mortality, linking death index information with medical/pharmacy claims data

• Concomitant use of benzodiazepines

• Gender disparities

Annual review of drugs added to the Medi-Cal List of Contract Drugs (ongoing, presented each November)

New 2016 Adult Core Set Measures:

• Diabetes Screening for People With Schizophrenia or Bipolar Disorder Who Are Using Antipsychotic Medications (SSD)

• Use of Opioids at High Dosage (OHD)


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