Ventura County Grand Jury 2017 - 2018 Final Report Ventura County Medical Center 340B Drug Pricing Program April 26, 2018 This page intentional/y blank Ventura County 2017 – 2018 Grand Jury Final Report Ventura County Medical Center 340B Drug Pricing Program Summary The 2017-2018 Ventura County Grand Jury (Grand Jury) opened an investigation after receiving a complaint about the Ventura County Medical Center’s (VCMC) 340B Drug Pricing Program (340B program). The 340B program requires pharmaceutical companies to provide prescription drugs at significant discounts to hospitals and clinics serving large numbers of low-income patients. In July 2015 an audit of VCMC was conducted by the federal Health Resources and Services Administration (HRSA). The audit discovered that VCMC received duplicate discounts on medications in the 340B program. A total of 107 pharmaceutical companies were affected by the duplicate discount billing. The total duplicate discounts were in excess of $3 million. The Grand Jury concluded there was inadequate oversight of the VCMC 340B program prior to the HRSA audit. This resulted in VCMC being required to reimburse pharmaceutical companies at least $861,000 and potentially as much as $1.6 million. The Grand Jury concluded while VCMC conducts its own in-house audits of the 340B program, more critical audits should be conducted by an independent outside party. The Grand Jury recommends VCMC consider bringing in outside resources with extensive 340B program experience to assist in the supervision of a corrective action plan. The Grand Jury also recommends VCMC request the Ventura County Auditor-Controller conduct regular compliance audits of the 340B program. Background The 340B program was created in 1992 as part of the Public Health Services Act. It requires pharmaceutical companies to provide prescription drugs at significant discounts to hospitals and clinics that serve large numbers of low-income patients. Medicare then reimburses those hospitals and clinics at a higher rate than what they paid, allowing them to keep the difference and pay for expanded patient services. More than 12,000 entities now participate in the multibillion-dollar program. The 340B program allows Disproportionate Share Hospitals (DSH) and Federally Qualified Health Centers (FQHC) to receive discounts on the purchase of selected drugs used for patients at qualifying hospitals and clinics. The 340B program is monitored by the Office of Pharmacy Affairs (OPA) of the HRSA. Following a review by the U. S. House Energy and Commerce Committee, Congress may push for substantial changes to bring transparency and oversight to 340B by expanding the federal government’s authority over the program. The House review VCMC 340B Program 1 Ventura County 2017 – 2018 Grand Jury Final Report found participating hospitals and clinics aren’t required to track how much they’re saving through the program or how they are using the money. (Ref-03) In 2012, VCMC began using Verity Solutions as a split-billing service, while still using another group purchasing organization (GPO) to bill under the 340B program. This resulted in duplicate discounts for the same drugs. Split-billing is the division of a bill for service into two or more parts. Bills may be split to divide work between clients, payers for reimbursement to different service providers, and for performing shared services. In July 2015 an audit of VCMC was conducted by HRSA. The audit discovered that VCMC received duplicate discounts on medications in the 340B program. A total of 107 pharmaceutical companies were affected by the duplicate discount billing. The total duplicate discounts were in excess of $3 million. The HRSA required VCMC to notify the pharmaceutical manufacturers impacted and to set up a repayment plan. Methodology The Grand Jury conducted internet research and witness interviews. The Grand Jury also reviewed: • The HRSA audit of VCMC’s 340B program • The VCMC corrective action plan • The list of pharmaceutical manufacturers and the status of the repayment plan • VCMC’s performance compared to other California hospitals participating in the 340B program • The performance of GPOs in the 340B program Facts FA-01. VCMC was audited by HRSA in 2015. The results of the audit revealed VCMC was in violation of the 340B program in five major areas, including receiving duplicate discounts on 340B program medications. After the HRSA audit, VCMC was required to pay back money to pharmaceutical companies and placed on probation by the OPA. (Ref-01) FA-02. There are approximately 500 hospitals in the state of California in the 340B program, 95% of those hospitals are in compliance. (Ref-02) FA-03. VCMC implemented a corrective action plan in July 2015. VCMC is using the same in-house personnel to monitor and audit the 340B program after the HRSA audit. (Att-02) FA-04. VCMC uses an outside contractor, Verity Solutions, for the billing of 340B drugs. While it was hired in 2012, Verity Solutions was not fully functional until 2015. During this time period, VCMC was also using a GPO for billing. (Att-02) 2 VCMC 340B Program Ventura County 2017 – 2018 Grand Jury Final Report FA-05. The simultaneous use of two billing entities resulted in VCMC claiming duplicate discounts. Duplicate discounts occur when companies sell drugs at a discount under the 340B program to VCMC and then VCMC also claims Medicaid rebates on the same drugs. (Ref-01) FA-06. VCMC has completed negotiations with 23 pharmaceutical companies. The original amount owed these companies was $2.1 million. As a result of the negotiations, VCMC was able to reduce their repayment to $861,000. VCMC is still in negotiation with two other pharmaceutical companies over a potential repayment of $428,000. (Att-01) FA-07. Nineteen pharmaceutical companies forgave the duplicate discounting and are not requiring repayment of $361,000. (Att-01) FA-08. There are 53 pharmaceutical companies who have been unresponsive to date. The potential amount owed is $976,000. (Att-01) FA-09. VCMC had no controls in place to ensure proper accumulation and to avoid improper diversion of 340B drugs. FA-10. With increased Congressional interest, the federal government is likely to scrutinize the 340B program, calling for more audits and justification on how the program money is spent. (Ref-03) Conclusions C-01. The Grand Jury concluded there was not proper oversight of the VCMC 340B program prior to the 2015 HRSA audit. This has resulted in VCMC reimbursing pharmaceutical companies at least $861,000 and potentially as much as $1.6 million. (FA-01, FA-02, FA-03, FA-06, FA-07, FA-08) C-02. The Grand Jury concluded that before the 2015 HRSA audit, there were few controls in place in the 340B program and no checks to see if VCMC was in compliance with HRSA. (FA-01, FA-02) C-03. The Grand Jury concluded that the extensive corrective action plan created for the VCMC 340B program after the 2015 HRSA audit appears to have adequate safeguards to prevent duplicate discounting in the future. (FA-04, FA-05) C-04. The Grand Jury concluded while VCMC conducts its own in-house audits of the 340B program, more critical audits should be conducted by an independent outside party. (FA-03, FA-09) C-05. The Grand Jury concluded the federal government is likely to demand VCMC track its use of 340B money and program savings. (FA-10) Recommendations R-01. The Grand Jury recommends VCMC consider bringing in outside resources with extensive 340B program experience to assist in the supervision of the corrective action plan. (C-01, C-02, C-03) VCMC 340B Program 3 Ventura County 2017 – 2018 Grand Jury Final Report R-02. The Grand Jury recommends VCMC request the Ventura County AuditorController conduct regular compliance audits of the 340B program. (C-03, C-04) R-03. The Grand Jury recommends VCMC continue in-house audits and share all results and recommendations with employees and the public. (C-03, C-04) R-04. The Grand Jury recommends VCMC study the management, personnel, and operational changes necessary to ensure the violation-free operation of the 340B program. (C-01, C-02) R-05. The Grand Jury recommends that VCMC establish a system to track how the money from the 340B program is used, as this is likely to be a subject of future Congressional interest. (C-05) Responses Responses Requested From: Ventura County Health Care Agency, Ventura County Medical Center (C-01, C-02, C-03, C-04, C-05, R-01, R-02, R-03, R-04, R-05) References Ref-01. Health Resources & Services Administration, Program Integrity: FY15 Audit Results. https://www.hrsa.gov/opa/program-integrity/auditresults/fy-15-audit-results.html Accessed April 19, 2018 Ref-02. 340BHealth, 340B Hospitals in California https://www.340bhealth.org/files/CA.pdf Accessed April 19, 2018 Ref-03. Ellen Weaver and Lindsay Boyd. The Hill. June 15, 2016. States tell Congress: stop hospital abuse of federal drug discount program. http://thehill.com/blogs/congress-blog/healthcare/283491-states-tellcongress-stop-hospital-abuse-of-federal-drug Accessed April 19, 2018 Attachments Att-01. Pharmaceutical Company Repayment Att-02. Cover Letter VCMC Corrective Action Plan 4 VCMC 340B Program Ventura County 2017 – 2018 Grand Jury Final Report Glossary TERM DEFINITION DSH Disproportional Share Hospitals FQHC Federally Qualified Health Care GPO Group Purchasing Organization Grand Jury 2017-2018 Ventura County Grand Jury HRSA Health Resources and Service Administration VCMC Ventura County Medical Center VCMC 340B Program 5 Ventura County 2017 – 2018 Grand Jury Attachment 01 Pharmaceutical Company Repayment 6 VCMC 340B Program Final Report Ventura County 2017 – 2018 Grand Jury Final Report Drug manufacturers that confirmed that they do not participate in 340B Drug Pricing Program 5 Drug Manufacturers Amerinet BTG International Cetylite Industries Inc. Gordon Laboratories Nestle Total Amount Owed: $0 No contact information available 5 Drug Manufacturers Claris Lifesciences Inc. $ 838.48 Medimetriks Pharmaceuticals Inc. $ 520.81 Fagron $ 114.75 VI Jon Inc. $ 41.45 nd $ 2.51 22 Century Nutritional Potential total amount owed $1,518.00* *VCMC considers these matters closed. Drug manufacturers who participate in the 340B Drug Pricing Program must register with HRSA. No such registration could be identified and a web browser search resulted in no findings. Complete forgiveness granted or no repayment owed 19 Drug Manufacturers Amount Forgiven Theracom $ 318,807.10 Mallinckrodt LLC $ 27,578.30 Jazz Pharmaceuticals $ 6,210.68 Cumberland Pharma Rx $ 2,537.18 Ferndale Laboratories Inc. $ 2,372.98 Wallace Pharmaceuticals $ 1,460.29 GE Healthcare $ 1,033.54 ECI Pharmaceuticals LLC $ 677.33 Halozyme Inc. $ 531.05 Alvogen Inc. CS $ 217.43 County Line $ 188.91 Prestium Pharma Inc. $ 133.56 Rhodes Pharmaceuticals $ 88.06 Edenbridge Pharmaceuticals $ 70.93 Sigmapharm $ 67.90 Plus Pharma Inc. $ 50.93 Molnlycke Healthcare $ 15.67 Sanofi-Pasteur $ 0 Allergan Inc. $ 0 Total Amount Forgiven: $ 361,008.30 VCMC 340B Program 7 Ventura County 2017 – 2018 Grand Jury Completed Negotiations 23 Drug Manufacturers Original Amount Owed Hospira Eli Lilly and Company Sanofi-Aventis US LLC Baxter Healthcare Corp. AstraZeneca Astellas Chiesi Grifols Biologicals Inc. Sagent Pharmaceuticals Inc. Accord Healthcare Inc. Sandoz Inc. W G Critical Care Johnson & Johnson X-Gen Pharmaceuticals Inc. Perrigo Co. Theravance Bayer Healthcare Nephron Pharmaceuticals Corp. Heritage Pharmaceuticals Inc. Lannett Company Inc. CMP Pharma Inc. Shire Inc. Leadiant (fka Sigma-Tau) Total Amount Final Amount Owed $ 569,088.55 $ 358,590.23 $ 286,294.79 $ 236,292.42 $ 212,553.24 $ 97,577.27 $ 58,679.71 $ 49,766.36 $ 45,540.27 $ 25,872.17 $ 22,211.26 $ 20,560.21 $ 20,309.77 $ 19,900.61 $ 15,878.89 $ 13,719.64 $ 12,357.96 $ 7,068.68 $ 6,585.93 $ 4,971.36 $ 3,501.09 $ 1,277.59 $ 5,939.89 $2,094,537.89 Negotiations in Process 2 Drug Manufacturers Pfizer Inc. GlaxoSmithKline Total Potential Repayment Owed: $ 130,893.65 $ 63,436.65 $ 44,596.95 $ 96,797.79 $ 212,553.24 $ 97,577.27 $ 28,921.22 $ 20,040.00 $ 45,540.27 $ 25,872.17 $ 22,211.26 $ 2,100.00 $ 15,232.33 $ 19,900.61 $ 6,799.98 $ 6,850.00 $ 115.11 $ 7,068.68 $ 3,500.00 $ 3,000.00 $ 1,750.55 $ 765.74 $ 5,939.89 $861,463.36 Potential Amount Owed $ 339,999.59 $ 87,854.71 $ 427,854.30 Drug Manufacturers Unresponsive 53 Drug Manufacturers Akorn CSL Behring Valeant Pharmaceuticals Marathon Pharmaceuticals Inc. American Regent Laboratories West-Ward Pharmaceuticals Teva Pharmaceuticals USA Sun Pharmaceuticals Industries Inc. Par Pharmaceutical Amedra Pharma Novo Nordisk UCB Pharma Inc. 8 Final Report To Date Potential Amount Owed $ 125,696.30 $ 112,617.42 $ 95,236.13 $ 75,566.93 $ 75,399.29 $ 60,770.02 $ 58,997.53 $ 55,791.04 $ 49,881.09 $ 39,724.95 $ 33,188.48 (Unresponsive) $ 31,934.19 VCMC 340B Program Ventura County 2017 – 2018 Grand Jury Dr. Reddy’s Laboratories Inc. Pharmaceutical Associates Inc. AuroMedics Pharma LLC Merck Covis Actavis Pharma Braintree Labs. Warner Chilcott Patriot Pharm B. Braun Taro Pharmaceuticals, USA Amneal Pharmaceuticals Arbor Pharmaceuticals Upsher Smith Labs. Gravis Pharma CS Avkare Inc. Safecor Health Acella Pharmaceuticals Exela Pharma Sciences US Worldmeds LLC Octapharma USA SPD CB Fleet Co. Inc. Arzol Chemical Co. Jacobus Pharmaceuticals Co. Emergent Biosolutions Inc. Global Pharm Impax Labs. Silvergate Pharma Inc. Teligent Iroko Pharmaceuticals Century Pharmaceuticals Watson Actavis OTC HUB Pharmaceuticals Solco Healthcare US Beach Pharmaceuticals Focus Health Group Pharmacarable LLC Camber Pharma CS Graham Field Surgical Boca Pharmaceuticals Mason Vitamins BLU Pharmaceuticals Total Potential Repayment Owed Final Report $ 17,963.54 $ 16,381.87 $ 15,315.04 $ 14,555.65 $ 11,379.78 $ 10,397.95 $ 10,344.21(Unresponsive) $ 8,866.93 $ 7,999.10 $ 7,737.87 $ 5,280.89 $ 4,734.59 $ 4,111.30 $ 3,577.92 (Unresponsive) $ 3,094.26 $ 3,048.75 $ 2,523.63 $ 2,310.96 $ 2,240.31 $ 1,747.20 $ 1,296.74 $ 1,238.24 $ 965.07 $ 774.05 $ 756.05 $ 681.23 $ 456.19 $ 337.26 $ 283.40 $ 280.98 $ 194.24 $ 187.89 $ 131.82 $ 95.22 $ 71.50 $ 34.76 $ 24.79 $ 21.05 $ 7.90 $ 1.22 $ 0.75 $976,258.47 VCMC 340B Program 9 Ventura County 2017 – 2018 Grand Jury Attachment 02 Cover Letter VCMC Corrective Action Plan 10 VCMC 340B Program Final Report Ventura Countv 201 7 2018 Grand JurV Final Report vEriiuan trouuir MEDICAL CENTER Kim Mlleuen Associated with the UCLA School of Medicine A Division of the Ventura County Health Care Agency Bryan lifelong, MD April l1 2W6 MEdIcel Dlrector Grietal Hacker Dr. Krista M. Pharml'J. M5. LISPHS ?"93 Of?cer Director. I{Trflicc of Pharmacy Affairs Michael Basinger, RM Health Resources and Services Administration Interim Chlel Hume Executive Fishers Lane, Mail Stop EWUSA Kathleen Keiterheuae Roukvillo 2085? I{Zhiei Hcauita.'Dueratlens Leticia Rodriguez Ilear Director l'cdicy, enter Hospital Operations serves as a Iiirmai response and corrective action plan {Ch to the final report dated January 2 20 6 of the Drug Program audit conducted July 2? 5 for 1 r?entura County Medical ('Tcnterf?t?tTMC: 340131 If) issued by the Health Resources and Services Administration Office of Pharmacy M'i'airs torn). responses to liRSA?s specific audit ?ndings are set forth below: lilcgartlii'igl ohtrn?mvf cot-cred outpatient (fruga- rt (troop Purchasing firguuizrtti'on VCMC has fully implemented and completed its corrective action plan since November EUIS to maintain compliance with the GPCI prohibition. The VCMC Outpatient Infusion lCenter Pharmacy no longer utilizes a CPU account to purchase coveted drugs and instead utilizes only a 3405 account for all of its purchasing activities. Cardinal Health account #?i4494, GPO account for the VCMC Outpatient Infusion Center Pharmacy, was inactivated en Pchluary 22, 20 I to ensure no GPO medications are purchased by the Outpatient infusion Center Pharmacy in the future. Inpatient chemotherapy drugs purchased through a UFO or WAC account are procured by and physically stored in the 'v't'iMC Inpatient Pharmacy, separate from the drugs purchased for the Outpatient Infusion (.Ieliter. A sepalate physical inventory oflitpatienl chemotherapy drugs {stored in the VCMC inpatient Pharmacy) and outpatient chemotherapy drugs [stored in the Vt?ItvIt? Outpatient Infusion Center Pharmacy} ensures that VCMC is in compliance with the GPO prohibition at all times. VCMC also developed and currently follows Pharmacy Procedure: Supply Chain: for the purchase of chemotherapy for VCMC inpatient Pharmacy and Outpatient Infusion Pharmacy. A copy of the proced one document is included herewith as Attachment A. Additionally, Pharmacy Policy ft 70. Hi MPH Drag Pricing Program has been amended to ensure compliance with the GPO prohibition. Pt copy ?l?tl'lli policy document is included herewith as Attachment 13, page 3 A sample of twenty 3403 transactions in the VCMC Outpatient Infusion Center Pharmacy will be audited on a quarterly basis to ensure compliance with 3408 Program requirements, including but not limited to the GPO prohibition. Individuals responsible for implementation ate: Jason Pharml?l Director of Pharmacy Services Patricia Rl?ii Pharmacy Supervisor, Outpatient Infusion Center Pharmacy .Ioe RPli Pharmacy Operations Supervisor The education strategy regarding 34GB Program compliance will comprise of review of the pharmacy procedure {supply Chain: (Chemotherapy and Policy F?i' 3f}. 38 Drug Pricing Program by all pharmacy staff involved in purchasing and receiving medications. 3291 Lorna Vista Read Venture. CA 93003 - {505] 552-6053 . Fax {305]- 552-5158 1125 N. 10th Street - Santa Paula, CA Qau?o~ teas} ass-Baud ?Fav [505} 933?3491 mm.ventura.eruthea VCMC34OB Program 11 Ventura Countv 201 7 2018 Grand JurV Final Report Pharmacy Prdicy 371* 5?0. 18 3401? Drug Pricing Program has been reviewed and contains language pertaining to 340B Program compliance and oversight activities of coulrtict pharmacies. The individuals responsible for implementation are: loo 1? lynn, Phannacy (Ziperations Supervisor Jason Arimura. PharmD Director of Pharmacy Services Pharmacy stall" lesponsiblc for conducting the self-audits of the 3403 drug pricing program will be educated on how to perform internal aud its on 34GB transactions that occurred within the four walls of the hospital after a pharmacy procedure has been developed. Relevant VCMC staff will be educated immediately regarding any changes to internal audit procedures. Contract pharmacy stall" have already been re-educated on the process of selecting the correct entity when ?lling prescriptions for quali?ed outpatients and the ineligibility of I-lillmont lCounty Mental l-Icalth. Roget-ding Finding 3403 drugs H?Gl?o? not properiy ocrumuirnco?. riiri not have adequate controls in pint-r.- in ensure proper? (ifdivcrsion ofl'Ji?lB drugs, or prohibited by .t'cciion (5N3) ofihe PHSA, identi?ed the root cause: the report that is transferred from our electronic health record system to our accumulation soliwarc system does not account for medication administration events that are In order to account for these reversed medication administration events, has created a report of reversed medication adminislration events. This report will be reviewed weekly and adjustments will he made to accumulations in the accumulation software system accordingly. This process will be implemented by May I. and will adjust the accumulations fortu ['6va medication administration events tinting back December 5, 20] 5. Other audits VCMC will conduct of its accumulation software system include weekly review of unknown items, upd etc of vendor item master ?le, and quarterly audit of? multipliers. These processes will be implemented by May I, 2016. Detailed procedures for each audit are available in Pharmacy Procedure 3403 Drug Pricing Program: Autumn! 3403 Sofhvorc di' Audits. it copy of this procedure is included herewith as Attachment C. Pharmacy Poiicy Pi id. id 34015 Drug Pricing Progmm has been amended to include this process as part of its system to reasonably ensure ongoing compliance with all 34013 Drug Pricing Program VCMC will audit 3 random sample of thirty dispensed 3403 medications from the AutoSplit 3MB accumulation software reports on a quarterly basis. Each randomly selected diSpensed 3408 medication will be reviewed to ensure the patient receiving the 34GB medication is a quali?ed outpatient. VCMC considers patients in an outpatient encounter in one locations registered as a parent or child site for 3403 ID DSHUSOI 59 on 3403 registration database as a quali?ed outpatient. These quarterly audits of diSpenscd 34GB medications will be implemented by May 1, Eli] I5. Pharmacy Poiicy 17! F0. id 3403 Drug Pricing Program has been amended to include this process as part of its system to reasonably ensure ongoing compliance with all 3403 Drug Pricing Program requirements. VCMC is in the process ofcontracting with Verity Solutions Group, inc. for its Autosplit 34GB Fully Managed services to provide additional oversight of existing 34'03 split billing software system, Autosplit 340B. Autosplit 34013 Fully Managed services will be implemented by June 1, 2016. For its 3403 contract pharmacies. VCMC has contracted with 1Verity Solutions Group. Inc. to perform annual independent and its to supplement self?audits. The ?rst annual independent audit with Verity Solutions Group, Inc. will be by June l7, 2W6. Individuals responsible for implementation are: Joe Phannacy Operations Supervisor Jason Arimurs, PharmD Director of Pharmacy Services Pharmacy staff responsible for conducting the self-audits of the 34GB drug pricing program will be educated on how to perform internal audits on 3403 transactions that occurred within the four walls of the hospital by May I, 21] I6. Relevant VCMC staff will be immediately educated as to any changes to internal audit prooedures. 3291 Lorna Vista Road - Ventura. CA 93903 [305} 652-50513 - Fax (805) 652-6163 325 N. [Ull?l Street Santa Paula. CA 930130 - 933-5300 Fali {305} 333-3491 12 VCMC340B Program Ventura Countv 201 7 2018 Grand JurV Final Report Regarding Finding 5: Vt 'Mt tinted or hitting in (Jr-motion on the 3403 Medicaid Erel'm'i'on Fife. this may have Fortified in dopiicm?e dis-counts as prohibited it}: section JJUBl?ojfjji?A) (grim PHSA. VCMC corrected the Medicaid number and National Provider Index ntunbors used to bill Medicaid on the 3403 Medicaid Exclusion File while the surveyor was on site July 7-9. VCMC will review its 3403 database inliirmation annually and any time a change is made to the 3403 database. The OPt?t Will be noti?ed oi" any changes through a change requested submitted through HRSA 3405 website. To ensure duplicate discounts with Medicaid are not occurring. VCMC will conduct quarterly audits oftwenty randomly selected 34013 medicalions dispensed to Medicaid patients and con?rm that the Medicaid number and National Provider Index numbers used to bill Medicaid on the Medicaid [Exclusion File are accurate. Detailed procedures for caeh audil are available in Phi-armory Procedure .3in3 Drug Pricing Program: Quarterly Veri?cation ry'Meci'icoid hicimion File. A copy of this procedure is included herewith as Attachment H. Pharmacy Policy TH 70. ES 3403 Drug to reasonably ensure ongoing Praia-inn ?ruin-run hm: hunt-I tn in?llit'ln ill-lie pimp-(Io or: naut- n'F i+e~ ouch?IIcompliance With all MOB Drug Pricing Program requirements. this individuals responsible For implementation are; lot: Pharmacy Operations Supervisor Jason Phal'ltil) Pharmacy Services An internal has been to the administration of Ambulatory (fare and Fiscal divisions ot'lhe Ventura County Ileallh ("are Agency regarding the necesaily to Communicate any changes that may potentially impact 34GB participation lior any component to Joe or Jason Arimura so that any and all changes are reported to OPA immediately as required to maintain 3403 Program compliance. A copy ofthe internal communication is included herewith as Attachment D. VCMC appreciates l-thfi?s decision to not remove VCMC from the 3403 Program and affording it an opportunity to to ll?llf agency's audit ?ndings. is linpelill that the inlhl?l'natiml included in this letter, along with the allached documents. demon str'alcs a satisfactory corrective aclion plan. Should IIRSA have additional questions about any points raised itt this letter or need additional information From please contact the undersigned. in addition to the foregoing, as discussed in letter that accompanied the linal report. VCMC will work with HRSA to provide public notice oi?any 340a infractions that might have made VCMC liable to drug manufacturers for repayment of? improperly obtained drug discounts. VCMC will await additional guidance from HRSA regarding such public notice alter the agency has approved VCMC's CAP. ?l'hank you. Kathleen Kellerhousc Chief Hospital Operations Ventura County Medical Center 3291 Lorna Vista Road IVentura, CA 93003 (805) 652-6052 Attachments: A. Pharmacy Pl'oeedure: Supply Chain: Chemotherapy B. Pharmacy Policy Ti). 8 34GB Drug Pricing Program (I. Con?rmation Email for Unline talus termination Request D. Memorandum on 3403 Program Registration Changes 3291 Lorna Vista Road - Ventura, CA [305] 652-6053 . Fax {305} 652n61t38 825 N. 10th Street . Santa Paula, GA 93050 - {805] 933-3800 - Fax [305) 933-3491 W.uentura.orgmea VCMC340B Program 13 Ventura Countv 201 7 2018 Grand JurV Final Report E. Pharmacy Procedure: 3413B Drug Pricing Program: Audit of 34GB Medications Dispensed Within the Four Walls of the Hospital F. Pharmacy,f Procedure: 3403 Drug Pricing Program: Contract Pharmacy Oversight G. Pharmacy Procedure: 340B Drug Pricing Program: Autosplit Software Maintenance e, Audits H. Pharmacy Procedure: :34le Drug Pricing Program: cc: Barry R. Fisher, MFPA, Director, Ventura County Health Care Agency Kim Milstien, Chief Executivc Of?cer, Ventura County Medical Center Catherine Rodriguez, Interim Chief Financial Of?cer, Ventura County Health Care Agency Dec Pupa, Deputy Director-Patient Accounting, Ventura County Health Care Agency Jaeon Arimura, Pharm D, BCPS, Director of Pharmacy Scrviccs, Ventura Countyr Medical Center 14 VCMC 3403 Program