OptumRx pharmacy manual

Transcription

1 OptumRx 2014 pharmacy manual

2 Table of contents Click on any section or page below to go directly to that portion of the document. I. Introduction...4 II. How to contact us and how we contact you....6 Pharmacy help desk / customer service numbers... 7 Prior authorization (PA) department Electronic data interchange (EDI)... 8 Pharmacy network contracting department...8 Provider feedback forms...8 Pharmacy notification...9 III. Customer identification cards...10 Best available evidence (BAE) All pharmacy types EXCLUDING long-term care (LTC) providers Long-term care (LTC) providers ONLY IV. Claims process...15 A. General process...16 B. Required prescription information C. Dispense as written (DAW) D. Electronic remittance advice (ERA) program E. Electronic funds transfer (EFT) program F. Member/insured appeals and grievances G. Utilization management H. Concurrent drug utilization review ( cdur ) I. Retrospective drug utilization review ( rdur )/clinical programs...30 J. MAC review requests...32 V. Products...33 VI. Medicare product information and guidelines...35 Excluded drugs...36 Medicare Part A/B/D coordination of benefits...37 Medicare Part D coverage determinations...37 Time frames...38 OptumRx pharmacy manual: 7th edition 2

3 Table of contents Click on any section or page below to go directly to that portion of the document. Coverage limitations...38 Medication therapy management (MTM) program Medicare Part D transition policy...40 Medicare Part D transitioning long-term care (LTC) facility residents Long-term care facility information to be provided upon termination Short-cycle dispensing (SCD) processing for long-term care Daily cost share (DCS), a CMS requirement Medicare Part D sixty (60) day negative formulary change notice Medicare Part D annual notice of change for continuing members...45 Inform members of advance directives Provide timely notice of demographic changes...45 VII. Other general terms and conditions...46 A. Compliance...47 B. Pharmacy fraud, waste and abuse and general compliance training C. Pharmacy audits D. Credentialing E. Confidentiality and proprietary rights...58 F. Involuntary disenrollment by benefit plan or sponsor...58 G. State medicaid requirements H. Definitions Exhibit A...62 Exhibit B Exhibit C Exhibit D...66 Exhibit E Exhibit F...69 Exhibit G...70 OptumRx pharmacy manual: 7th edition 3

4 I. Introduction OptumRx pharmacy manual: 7th edition 4

5 The OptumRx Pharmacy Provider Manual (Manual) is intended to be a guide regarding the policies of OptumRx for pharmacies, Pharmacists and pharmacy staff (collectively, Network Pharmacy Providers ) who are parties to and serve customers pursuant to the Prescription Drug Services Agreement or the Pharmacy Network Agreement, as amended (the Agreement ) with OptumRx, formerly Prescription Solutions, Inc. Please note: The information in this Manual is current at the time of the Manual s publication. While efforts are made to keep the information current, this Manual is subject to change without notice. This Manual is not designed to cover all circumstances or issues, nor is it a replacement for sound clinical judgment. Online adjudication of Claims will reflect the most current benefit and takes precedence over printed information. For your convenience, the defined terms in this Manual have the same meaning as used in the Agreement and are listed in the last section of this Manual. In the event that this Manual and the Agreement have conflicting language, the Agreement will supersede the Manual. For specific details regarding the governing elements of the relationship between OptumRx and its participating pharmacies, please refer to the Agreement. You may request a copy of the latest version of the Manual by calling or via to [email protected]. While we hope that most of your day-to-day questions concerning the OptumRx pharmacy program are adequately addressed in this Manual, please contact us if you have any questions. The OptumRx Faxblast communications that have been previously sent and sent after the date of receipt of this Manual to Network Pharmacy Providers are hereby incorporated by reference into this Manual, which the Manual is incorporated into the Agreement. OptumRx pharmacy manual: 7th edition 5

6 II. How to contact us and how we contact you OptumRx pharmacy manual: 7th edition 6

7 OptumRx strives to ensure that Pharmacies receive prompt and courteous attention when questions arise. For assistance in processing a claim or questions concerning OptumRx pharmacy programs, please contact us at the telephone number identified on the Member s identification (ID) card or contact us as indicated below. Pharmacy help desk service numbers: Hours of operation: 24 hours a day, 7 days a week For information regarding Benefit Plan exclusions, Disease Therapy Management (DTM) programs, or other customer service issues, please contact us using the following telephone numbers: Pharmacy help desk for members with UnitedHealthcare Medicare Advantage Prescription Drug Plan ( MAPD ): Telephone: TDHI (for the hearing impaired): Pharmacy help desk for members with UnitedHealthcare Medicare Prescription Drug Plan ( PDP ): Telephone: TDHI (for the hearing impaired): Pharmacy help desk for members with UnitedHealthcare Medicaid plans: Telephone: TDHI (for the hearing impaired): Pharmacy help desk for members with UnitedHealthcare commercial plans: Telephone: TDHI (for the hearing impaired): Pharmacy help desk for members with OptumRx commercial plans or plans not listed above: Telephone: TDHI (for the hearing impaired): Website: optumrx.com Prior authorization ( PA ) department: Hours of operation: 7 a.m. 7 p.m., PT, Monday Friday For questions concerning utilization management requirements, Medicare Part D ( Part D ) decisions, coverage limitations and PAs, please contact: Telephone: Fax:(Oral): (Specialty): OptumRx pharmacy manual: 7th edition 7

8 Electronic data interchange (EDI): Hours of operation: 8 a.m. 5 p.m., PT, Monday Friday For questions concerning Electronic Data Interchange (EDI), contact your EDI vendor or call the EDI support line at: Telephone: Pharmacy network contracting department: Hours of operation: 8 a.m. 5 p.m., PT, Monday Friday For information on network participation for a particular OptumRx benefit plan sponsor, please call or contact our pharmacy network contracting department at the following: Pharmacy network contracting department Von Karman MS: CA Irvine, CA Monday through Friday Phone: Fax: address: [email protected] For MAC review requests only: address: [email protected] Provider feedback forms: To facilitate feedback and comments from our Network Pharmacy Providers regarding the OptumRx Prior Authorization ( PA ) Guidelines and Outpatient Drug Formulary, the following forms are available: The Prior Authorization (PA) Guideline Change Request Form: The online submission for recommended change(s) in prior authorization guideline(s). The Formulary Change Request Form: Online submission for providers to submit a request related to recommendations for formulary change(s). Provider Feedback Forms are available at: optumrx.com/rxsolhcpweb/cmscontent.do?pageurl=/hcp/healthcareprovidertools/ FormsAndDocuments. Written requests can be submitted to the following: Prior authorization guideline change request form Clinical Programs OptumRx 2300 Main Street, CA Irvine, CA Fax: OptumRx pharmacy manual: 7th edition 8

9 Formulary change request form Clinical Formulary Management OptumRx 2300 Main Street, CA Irvine, CA Fax: New prescription fax form Fax: Please note: OptumRx is unable to accept incomplete Provider Feedback Forms. In order to avoid a delay in processing your request, please complete these forms in their entirety. Pharmacy notification: Faxblast communications Periodically, OptumRx communicates updates to procedures, formularies, pharmacy Manual, etc., via Faxblast communications. Faxblasts are sent electronically to the contracted network entity (independent pharmacy, retail chain (chain), Group Purchasing Organization (GPO) or Pharmacy Services Administration Organization (PSAO) corporate representative) via facsimile (fax) process. To request copies of previously sent Faxblasts, please contact: [email protected]. OptumRx pharmacy manual: 7th edition 9

10 III. Customer identification cards OptumRx pharmacy manual: 7th edition 10

11 Printed 12/16/13 This card does not guarantee coverage. Present your ID card along with your prescription when ordering your medication. If you have any questions regarding your pharmacy benefit program, please call Customer Service 7 days a week/24 hrs a day or check the website. For Members: optumrx.com Pharmacists: optumrx.com Claims: PO Box 29044, Hot Springs, AR Back The review and approval of health care services, based on medical necessity, does not guarantee coverage under your policy. Also, verification of eligibility for benefits and coverage does not guarantee coverage. Actual benefits and coverage will be determined under the terms and conditions of your policy when a claim is submitted. This Medical ID Card is to be used solely in connection with and is subject to the terms and conditions of your health or medical coverage issued or administered by UnitedHealthcare or its affiliates. UnitedHealthcare and its affiliates reserve all rights in the event of improper use. Gracias por elegirnos como proveedor de su plan de beneficios de atención de la salud. Adjuntamos su tarjeta de identificación del plan de salud de UnitedHealthcare. Empiece a usarla el día en que comience su cobertura. Administre su atención de la salud en línea en myuhc.com. Encontrará información y herramientas personalizadas para ayudarle a administrar reclamos y ver cuánto adeuda, encontrar un médico Gracias por sus elegirnos como proveedor de su plan de beneficios de u hospital, sus Adjuntamos costos de atención de de la salud, investigar de atención calcular de la salud. su tarjeta identificación deltemas plan de salud, y encontrar respuestas a sus preguntas atención la salud.su salud de UnitedHealthcare. Empiece a usarla elde día en que de comience Para obtener más ayuda, llámenosdeallanúmero que se encuentra en el cobertura. Administre su atención salud en línea en myuhc.com. reverso de su tarjeta. y herramientas personalizadas para ayudarle a Encontrará información The review and approval of health careyservices, based onadeuda, medical necessity, does notun guarantee coverage administrar sus reclamos ver cuánto encontrar médico u under your policy. Also, verification of eligibility benefits and coverage does not guarantee coverage. hospital, calcular sus costos de for atención de la salud, investigar temasactual de benefits and coverage will be determined under the terms and conditions ofatención your policy when ala claim is salud, y encontrar respuestas a sus preguntas de de salud. submitted. This Medical ID Card is to be used solely in connection with and is subject to the terms and Para obtener más ayuda, llámenos aladministered número by que se encuentra en el conditions of your health or medical coverage issued or UnitedHealthcare or its affiliates. reverso de su UnitedHealthcare andtarjeta. its affiliates reserve all rights in the event of improper use. Thank you for choosing us as your health care benefit plan provider. Manage your health care online at myuhc.com. You willbegin find using it on Attached is your UnitedHealthcare health plan ID card. personalized tools and starts. information to help you: the day your coverage Manage your claims and see how much you owe Find a doctor or hospital Manage your health care online at myuhc.com. You will find Estimate your health care costs personalized tools and information to help you: Research health topics Manage your claims and see how much you owe Find answers to your health care questions Find a doctor or hospital For more help, please call us at the number on the back of your card. Estimate your health care costs Research health topics Find answers to your health care questions For more help, please call us at the number on the back of your card. This card is for Pharmacy Benefits Administered by OptumRx 0000 A Thank you for choosing us as your health care benefit plan provider. Welcome to UnitedHealthcare Attached is your UnitedHealthcare health plan ID card. Begin using it on the day your coverage starts. Local Employee Benefit Fund Welcome to UnitedHealthcare UnitedHealthcare Ned Ruete CT A 185 Asylum Street Hartford CT UnitedHealthcare Ned Ruete CT A 185 Asylum Street Hartford CT LEBF SAM SAMPLE Download a free QR code reader and scan this code to learn about convenient Smartphone access to benefit and provider information with myuhc.com7 mobile. Rx BIN: Rx PCN: Rx GRP: Issuer (80840): Rx ID: Name: Download a free QR code reader and scan this code to learn about convenient Smartphone access to benefit and provider information with myuhc.com7 mobile. Important: Please register at myuhc.com to view your coverage and manage claims. Important: register myuhc.com to > Please at view your coverage EMPLOYEE SMITHand manage claims. 111 MAIN ST. > ANYTOWN ST EMPLOYEE SMITH 111 MAIN ST. ANYTOWN ST SAMPLE MEMBER ID CARDS: Next *114* *114* Below are samples of Member ID cards representing a couple of our Benefit Plan sponsors. This is a sampling only and is not an all-inclusive list. Member ID cards may be added, deleted or amended at any time. Contents Eligible Members ( Members ) receive an identification (ID) card containing information that helps our Network Pharmacy Providers submit Claims accurately and completely. Information may vary in appearance or location on the card due to employer, Benefit Plan, Sponsor or OptumRx requirements. However, cards display essentially the same information (e.g., Member Name, Subscriber Identification (ID), Group Number, Processor Control Number (PCN), Bank Identification Number (BIN), RxGroup Number (GROUP), and contact telephone numbers). RUN_DATE DATA_SEQ_NO CLIENT_NUMBER UHG_TYPE DOC_SEQ_ID DOC_ID NAME MAILSET_NUMBER CUSTCES_KEY _KEY0 CUSTCES_KEY2 CUSTCES_KEY3 CUSTCES_KEY4 CUSTCES_KEY5 CUSTCES_KEY6 CUSTCES_KEY7 CUSTCES_KEY8 CUSTCES_KEY9 RUN_DATE DATA_SEQ_NO CLIENT_NUMBER UHG_TYPE DOC_SEQ_ID DOC_ID NAME MAILSET_NUMBER CUSTCES_KEY _KEY0 CUSTCES_KEY2 CUSTCES_KEY3 CUSTCES_KEY4 CUSTCES_KEY5 CUSTCES_KEY6 CUSTCES_KEY7 CUSTCES_KEY8 CUSTCES_KEY9 SMITH SMITH DIG2CARD DIG2CARD EMPLOYEE HCAC/Medical ~00CARD ~01CARD ~02CARD ~03CARD ~04CARD ~00CARD ~01CARD ~02CARD ~03CARD ~04CARD ~00CARD ~01CARD ~02CARD ~03CARD ~04CARD ~00CARD ~01CARD ~02CARD ~03CARD ~04CARD EMPLOYEE HCAC/Medical ~00CARD ~01CARD ~02CARD ~03CARD ~04CARD ~00CARD ~01CARD ~02CARD ~03CARD ~04CARD ~00CARD ~01CARD ~02CARD ~03CARD ~04CARD ~00CARD ~01CARD ~02CARD ~03CARD ~04CARD CARD1 CARD :38:01 CARD1 CARD2 14:38:01,EMPLOYEE,EMPLOYEE Be sure to check the member s ID card at each visit especially the first visit of each new benefit year when information is most likely to change. Health Plan Health (80840) Plan (80840) EMPLOYEE EMPLOYEE SMITH SMITH HMO HMO Dependents Dependents SPOUSE SPOUSE SMITH SMITH CHILD1 SMITH CHILD1 SMITH CHILD2 SMITH CHILD2 SMITH CHILD3 SMITH CHILD3 SMITH Payer ID Payer ID Rx Bin: Rx Bin: Rx PCN: 9999 Rx PCN: 9999 Rx Grp: UHEALTH Rx Grp: UHEALTH Office: $30 Office:ER: $30$100 ER: $100 UrgCare: $20 UrgCare: $20 DOI-0501 DOI-0501 UnitedHealthcare UnitedHealthcare Choice Choice Underwritten Underwritten by [Appropriate by [Appropriate Legal Entity] Legal Entity] This card does This card not guarantee does not guarantee coverage.coverage. To verify benefits, To verifyview benefits, claims, view or claims, find or find a provider,a visit provider, the websites visit the or websites call. or call. For Members: For Members: Care24: Care24: Mental Health: Mental Health: For Providers: For Providers: Medical Medical Claims: Claims: PharmacyPharmacy Claims: OptumRx Claims: OptumRx PO Box PO Box Hot29044 Springs, Hot AR Springs, 71903AR For Pharmacists: For Pharmacists: Printed: 09/17/13 Printed: 09/17/13 This card does not guarantee coverage. Present your ID card along with your prescription when ordering your medication. If you have any questions regarding your pharmacy benefit program, please call Customer Service 7 days a week/24 hrs a day or check the website. Health Plan Health (80840) Plan (80840) For members: optumrx.com or Member ID: Member ID: Group Number: Group Number: Member:Pharmacists: Member: optumrx.com or HMO HMO EMPLOYEE EMPLOYEE SMITH SMITH Dependents Dependents Claims: Box 29044, Hot Springs, AR SPOUSE SPOUSE SMITH PO SMITH Payer ID Payer ID CHILD1 SMITH CHILD1 SMITH CHILD2 SMITH CHILD2 SMITH CHILD3 SMITH CHILD3 SMITH Rx Bin: Rx Bin: Rx PCN: 9999 Rx PCN: 9999 Office: $30 Office:ER: $30$100 ER: $100 Rx Grp: UHEALTH Rx Grp: UHEALTH UrgCare: $20 UrgCare: $20 OptumRx pharmacy manual: 7th edition This card does This card not guarantee does not guarantee coverage.coverage. To verify benefits, To verifyview benefits, claims, view or claims, find or find a provider,a visit provider, the websites visit the or websites call. or call. For Members: For Members: Care24: Care24: Mental Health: Mental Health: For Providers: For Providers: Medical Medical Claims: Claims: 11 Pharmacy Claims: OptumRx Claims: OptumRx PO Box PO Box Hot29044 Springs, Hot AR Springs, 71903AR UnitedHealthcare Choiceand Choice The information contained Underwritten in thisunitedhealthcare document isbyproprietary confidential to Pharmacy OptumRx. Underwritten by [Appropriate [Appropriate Legal Entity] Legal Entity] For Pharmacists: For Pharmacists: DOI-0501 DOI-0501 Exit Member ID: Member ID: Group Number: Group Number: Member: Member: Previous Printed: 09/17/13 Printed: 09/17/13

12 For instances when a Member does not have an ID card, please see the following: Situation: member does not have an ID card OptumRx UnitedHealthcare (UHC) skip to step 3 OptumRx UnitedHealthcare (UHC) skip to step 3 OptumRx UnitedHealthcare (UHC) Step 1 Step 2 Step 3 Step 4 UnitedHealthcare (UHC) Person is at the pharmacy, has no proof of coverage but states they are currently enrolled. Member may present generic marketing materials that were provided with the inquiry kits. 1) E1 transaction initiated to determine eligibility; this is done by the Pharmacist (a) Eligibility validated; Pharmacist processes prescription (b) Eligibility not validated or Pharmacist unable to access E1, move to step 2 Note: An E1 transaction can be initiated with the Member s Social Security Number (SSN) or Member s ID. Pharmacist contacts the OptumRx Pharmacy Help Desk using the contact information provided in Section II of this pharmacy Manual. (a) Pharmacy Help Desk validates eligibility and Claim is processed (b) Unable to validate eligibility, move to step 3 Pharmacy Help Desk completes transfer of Pharmacist to the UnitedHealthcare Call Center. Alternatively, the pharmacy may direct the Member to call their plan. 1) Call center confirms eligibility; Member eligibility entered real-time into OptumRx system; Pharmacist fills prescription. 2) Unable to confirm eligibility or eligibility has been denied; person pays retail for drug; fourteen (14) day window to allow for online processing at pharmacy when eligibility issue resolved or person to submit a paper Claim for reimbursement. 3) Person unwilling to pay retail, prescription not filled. Person is at the pharmacy, has an acknowledgement or confirmation letter with an enrollee number and states that they are enrolled. 1) E1 transaction initiated to determine eligibility or Pharmacist attempts to process Claim online; this is done by the Pharmacist (a) Eligibility validated; Pharmacist processes prescription online (b) Eligibility not validated or Pharmacist unable to access E1, move to step 2 Pharmacist contacts the OptumRx Pharmacy Help Desk using the contact information provided in Section II of this pharmacy Manual. (a) Pharmacy Help Desk validates eligibility and Claim is processed (b) Unable to validate eligibility, move to step 3 Pharmacy Help Desk completes transfer of Pharmacist to the UnitedHealthcare Call Center. Alternatively, the pharmacy may direct the Member to call their plan. 1) Call center confirms eligibility; Member eligibility entered realtime into OptumRx system; Pharmacist fills prescription. 2) Unable to confirm eligibility, eligibility pending, eligibility has been denied, or a disenrollment was processed; person pays retail for drug; fourteen (14) day window to allow for online processing at pharmacy when eligibility issue resolved or person to submit a paper Claim for reimbursement. 3) Person unwilling to pay retail, prescription not filled. OptumRx pharmacy manual: 7th edition 12

13 Best available evidence (BAE) All pharmacy types EXCLUDING long-term care (LTC) providers If a Member questions their copayment amount, or states that they qualify for federal subsidy or extra help, they must have valid supporting documentation in order to receive the lower copayment level amount. Any of the following documents are acceptable and meet the criteria as Best Available Evidence (BAE) to support a Member s qualification for federal subsidy: A copy of the beneficiary s Medicaid card that includes the beneficiary s name and eligibility date status during a month which occurred after June 30 of the previous calendar year; A copy of a State document that confirms active Medicaid status during a month which occurred after June 30 of the previous calendar year; A printed document from the State electronic enrollment file showing Medicaid status during a month which occurred after June 30 of the previous calendar year; A screen print from the State s Medicaid systems showing Medicaid status during a month which occurred after June 30 of the previous calendar year; Other documentation provided by the State or Centers for Medicare and Medicaid Services (CMS) showing Medicaid status during a month which occurred after June 30 of the previous calendar year; A copy of the Social Security Administration (SSA) award letter for those individuals who are not deemed eligible, but who apply for and are found to be Low Income Subsidy ( LIS ) eligible. To correct a member s subsidy level utilizing BAE, please secure one (1) of the above documents from the Member and contact Customer Service at the phone number provided on the back of the Member s ID card. Please note: Provided the documentation received meets the BAE criteria, the Member s copayment will be adjusted within forty-eight (48) to seventy-two (72) hours of receipt of BAE documentation. Reprocess the prescription(s) to capture the lower copayment amount. If you have any questions on BAE, please contact Customer Service at the phone number provided on the back of the Member s ID card. OptumRx pharmacy manual: 7th edition 13

14 Long-term care (LTC) providers ONLY If a Member questions their copayment amount, or states that they qualify for the institutional status zero (0) cost sharing, they must have valid documentation supporting this position in order to receive the zero (0) copayment amount. Any of the following documents are acceptable and meet the criteria as Best Available Evidence (BAE) supporting a Member s institutional status and qualification for zero (0) cost sharing: A remittance from the facility showing Medicaid payment for a full calendar month for the beneficiary during a month after June 30 of the previous calendar year; A copy of the state document that confirms Medicaid payment for a full calendar month for the beneficiary during a month after June 30 of the previous calendar year; A screen print from the State s Medicaid systems showing the beneficiary s institutional status for at least a full calendar month stay for Medicaid payment purposes during a month after June 30 of the previous calendar year. To correct a Member s subsidy level utilizing BAE, please secure one (1) of the above documents from the Member and contact Customer Service at the phone number provided on the back of the Member s ID card. Please note: Provided that the documentation received meets the BAE criteria, the Member s copayment will be adjusted within forty-eight (48) to seventy-two (72) hours of receipt of BAE documentation. Reprocess the prescription(s) to capture the lower copayment amount. If you have any questions on BAE, please contact Customer Service at the phone number provided on the back of the ID card. OptumRx pharmacy manual: 7th edition 14

15 IV. Claims process OptumRx pharmacy manual: 7th edition 15

16 A. General process The following describes the OptumRx processes and procedures for processing Claims. Complete claims OptumRx requires the submission of a Clean Claim, as described in pharmacy contract Section: Recitals/Defined Terms. Because a Member s level of coverage under his or her Benefit Plan may vary for different services, it is particularly important to correctly code, according to the National Council for Prescription Drug programs (NCPDP) standards, in order to submit pharmacy Claims for proper payment and application of deductibles, coinsurance or copayments. Pharmacies should use best efforts to submit complete and accurate claims at the point of sale, but must reverse and resubmit Clean Claims electronically within thirty (30) days of the original submission. Please note, for federal programs that we support: Federal regulations prohibit us from paying Claims for medications prescribed by providers that have been excluded from federal program participation as evidenced by listing of the prescriber within the Health and Human Services (HHS) Office of Inspector General (OIG) or General Services Administration (GSA) Excluded and Sanctioned Providers listings. These OIG or GSA lists are checked monthly and Claims for medications by excluded providers will be rejected. The Claim will reject with the NCPDP Rejection Code 71 MD NOT COVERED SANCTIONED PRESCRIBER. Claims may only be paid for prescriptions properly prescribed in accordance with Federal and State prescribing laws and regulations. Please ensure that pharmacy and pharmacy staff maintain up-to-date knowledge of Federal and State prescribing rules and that pharmacy will not submit a claim for a prescription not fully compliant with applicable Federal and State prescribing laws and regulations. Federal regulations for schedule II drugs Pursuant to Federal regulations in Title 21 of the Code of Federal Regulations (CFR) (a), Schedule II prescription drugs may not be refilled. A separate prescription is required if a physician wishes to authorize continuation of a patient s use of a Schedule II drug beyond the amount specified on the first prescription. The regulations at 21 CFR (b) allow for a prescription for a Schedule II drug written for a patient in a long-term care facility or for a patient with a medical diagnosis documenting a terminal illness to be filled in partial quantities to include individual dosage units. Under this provision, a Schedule II drug may be partially filled as long as the total quantity dispensed does not exceed the total quantity prescribed. The prescription is valid for a period not to exceed sixty (60) days from this date. The regulations at 21 CFR (a) also permit the partial filling of a prescription for a Schedule II drug if the pharmacist is unable to supply the full quantity prescribed. The remaining portion of the prescription may be filled within seventy-two (72) hours of the first partial filling; however, if the remaining portion is not or cannot be filled within the seventy-two (72) hour period, the pharmacist may not dispense any further quantity without a new prescription. According to 21 CFR , except in emergency situations or when dispensed directly by a practitioner other than a pharmacist to the ultimate user, Schedule II drugs may not be dispensed without a practitioner s written prescription. In the case of an emergency situation, a pharmacist may dispense Schedule II drugs upon receiving an oral authorization from a prescribing practitioner, provided that, among other things, the prescription is immediately reduced to writing by the pharmacists and contains all information required in 21 CFR , except for the signature of the prescribing practitioner. OptumRx pharmacy manual: 7th edition 16

17 Online Processing Window The Online Processing Window to submit electronic claims is as follows: Medicare Part D claims: One-hundred and eighty (180) days Commercial claims: Sixty (60) days Medicaid claims: Sixty (60) days Please note: OptumRx is unable to extend these time frames. Pharmacies that need to process claims outside the Online Processing Window time frame for submission of electronic claims will be required to submit a Universal Claim Form (UCF) and an explanation for the late submission. Submission of the UCF is not a guarantee claim(s) will be paid. Payment is determined on a case-per-case basis upon review of explanation of late submission and plan approvals. Please mail completed UCF and explanation for late submission request to: OptumRx P.O. Box Hot Springs, AR Pharmacy processing information and notices As a reminder, all claims, including Medicare Part D must be submitted using the Bank Identification Number ( BIN ), Processor Control Number ( PCN ) and Submitted Group ( Group ) that appears on the Member s ID card. Payer sheets The OptumRx D.0 Payer sheets are available on the health care professionals portal via the following: optumrx.com/rxsolhcpweb/cmscontent.do?pageurl=/hcp/healthcareprovidertools/formsanddocuments Submitting compounds A compounded prescription consists of two (2) or more solid, semisolid, or liquid ingredients one of which is a Federal Legend Drug that is weighed, measured, prepared, or mixed extemporaneously according to the prescription order to make a product that is not commercially available. The Network Pharmacy Provider is responsible for compounding preparations with approved ingredients only. Ingredients need to be of an acceptable strength, quantity and purity and must have the appropriate labeling and packaging in accordance with good compounding practices, official standards, and scientific information. The Network Pharmacy Provider is responsible for documenting the drug name, National Drug Code (NDC) of the package size used, and metric quantity of each component used to prepare the compounded prescription. Important points to remember when submitting multi-ingredient compounded prescriptions under version D.0 (applies to ALL BIN s): Single-ingredient compound billing will not be accepted. OptumRx pharmacy manual: 7th edition 17

18 Each individual ingredient should be represented by the NDC of the product(s) used, including: The total quantity of each specific ingredient The cost of each individual ingredient with basis of cost determination Up to twenty five (25) ingredients may be entered for each compounded prescription claim Submit the NDC number (Product/Service Identification) in the claim segment as 0 (zero) and the Product/Service Identification qualifier should be submitted as 00 (two zeros). Use the correct compound segment to identify each individual ingredient. Submit a Compound Code of 2 (two) in field 406-D6 in accordance with National Council for Prescription Drug Programs (NCPDP) standards as defined in the OptumRx payer sheets for Version D.0. A minimum of two (2) and a maximum of twenty-five (25) ingredients will be accepted. Submit the quantity dispensed as the total metric quantity of the finished product, including: Sum of all individual ingredient costs as the Pharmacy s Ingredient Cost Submitted for the compounded prescription Submit the Pharmacy s Usual & Customary (U&C) for the compounded prescription Members should be charged the applicable copayment indicated only. Prescription Drug Compensation for compounded medications dispensed to Members that are Covered Prescription Services will be at the Pharmacy s agreed upon Prescription Drug Contracted Rate for each approved ingredient submitted for the applicable network associated with the claim submission, plus a $7.50 compounding fee that is subject to change by Administrator. Please note the following exclusions: Reconstitution of an oral antibiotic or similar product is not considered to be a compounded prescription. Adding flavorings to a commercial product is not considered to be a compounded prescription. Charges for ancillary supplies, flavoring, equipment depreciation and/or labor are not eligible for reimbursement. Ingredients with missing or invalid NDC numbers are not eligible for reimbursement. Updated Payer Sheets related to Medicare Part D, Commercial and Medicaid can be located at the following: optumrx.com/rxsolhcpweb/cmscontent.do?pageurl=/hcp/healthcareprovidertools FormsAndDocuments National drug code (NDC) number Pharmacies should always submit the exact eleven (11) digit NDC number of the actual package size of the Drug Product dispensed. Vaccines The value of 2Ø in Submission Clarification Code (42Ø-DK) field Indicates that, prior to providing service, the pharmacy has determined the product being billed is purchased pursuant to rights available under Section 34ØB of the Public Health Act of 1992 including sub-ceiling purchases authorized by Section 34ØB (a)(1ø) and those made through the Prime Vendor Program (Section 34ØB(a)(8)). OptumRx pharmacy manual: 7th edition 18

19 National provider identification (NPI) number In compliance with Health Insurance Portability and Accountability Act of 1996 ( HIPAA ), the NPI is the required Pharmacy and Prescriber identifier. The NPI is a unique ten (10) digit identifier assigned to health care providers to use when submitting a HIPAA standard transaction. Pharmacy ID: OptumRx only accepts NPI as the pharmacy identifier for online Claims. Any Claims transmitted with a NCPDP or other ID number will be rejected. Although NPI numbers are required for Claims processing, we strongly encourage pharmacies to continue to register for an NCPDP ID and regularly update their information with NCPDP. Prescriber ID: The NPI of the prescribing physician is required for all Claims. At this time, OptumRx will not reject Claims transmitted with a legacy ID (unless instructed otherwise by a specific client). Although Claims will not be rejected, pharmacies should transmit the NPI whenever it is available. If the pharmacy does not have the prescriber s NPI on file, the pharmacy should make a reasonable attempt to obtain the NPI number. Please note: In order to avoid claims rejections, please ensure you carefully enter the correct prescriber DEA (Drug Enforcement Administration) and NPI numbers. Entering the correct prescriber DEA and NPI numbers also ensures that correspondence sent to providers based on pharmacy claims goes to the correct provider. Permissible prescriber identifiers for Medicare Part D claims For Medicare Part D and medicaid claims: Pharmacies should submit a prescriber ID on all Part D and Medicaid claim submissions. Claim submissions without a prescriber ID will result in a claim rejection with code EZ Missing/Invalid Prescriber ID. Organizational NPIs should not be submitted. NPI should be submitted using an individual NPI that is valid on the Date of Service (DOS) for the claim. Claims submitted without a valid individual prescriber NPI will reject with NCPDP Rejection Code 56 NPI EXISTS. PRESCRIBER ID INVALID/NOT ALLOWED and the corresponding NPI number will be provided for use when resubmitting the claim. We recognize that pharmacies cannot always obtain the prescriber s NPI at the point of service. If a prescriber s NPI absolutely cannot be obtained, a valid non-npi number (see below) will be allowed to prevent Member disruption (see below). However, we do encourage all pharmacies to use the prescriber s NPI when possible. The prescriber s DEA number will be accepted as an alternative to the NPI number only when there is no NPI number on file. If an invalid DEA is submitted, the claim will reject with Point of Service (POS) Messaging or NCPDP Rejection Code 25 MISSING OR INVALID PRESCRIBER ID. Invalid DEA number is defined as any expired DEA number or DEA numbers that are not registered with the DEA (i.e., default or pharmacy constructed DEA numbers). Prescribers with a current Health and Human Services Department (HHS) Office of Inspector General (OIG) sanction will be rejected. Prescriptions written for controlled substances: OptumRx will reject claims where the prescriber being submitted on the claim does not have the authority to write for the schedule drug being prescribed. Please note: In order to avoid claims rejections, please ensure you carefully enter the correct prescriber DEA (Drug Enforcement Administration) and NPI numbers. Entering the correct prescriber DEA and NPI numbers also ensures that correspondence sent to providers based on pharmacy claims goes to the correct provider. OptumRx pharmacy manual: 7th edition 19

20 Claim adjustments Members are responsible for applicable copayments, deductibles and coinsurance associated with their Benefit Plans. Medicare Part D Claim adjustments: Pharmacies will be unable to reverse Medicare Part D (Part D) claims that have been reprocessed internally by OptumRx. This is necessary because claim adjustments have been made and if a financial adjustment was owed to the member or Long-term care (LTC) pharmacy, then a reimbursement process has already been initiated. Pharmacies attempting to submit reversal requests on claims that have been reprocessed by OptumRx will receive a NCPDP Rejection stating CLAIM NOT ELIGIBLE FOR REVERSAL. CONTACT HELP DESK FOR ASSISTANCE. If there is a need to resubmit Claims due to incorrect Medicare Part D Low Income Subsidy (LIS) level, please contact Customer Service using the information provided in Section II of this pharmacy Manual. Manual changes to income subsidy levels may be overwritten by files received from CMS. This process would require monthly Manual updates until the Member s LIS level is transmitted by the appropriate Medicaid or Social Security Administration (SSA) office to CMS. Subrogation and coordination of benefits (COB) Benefit Plans are subject to subrogation and coordination of benefits (COB) rules: 1. Subrogation To the extent permitted under applicable law and the applicable Benefit Plan, we reserve the right to recover benefits paid for a Member s health care services when a third (3rd) party causes the Member s injury or illness. 2. COB Coordination of benefits (COB) is administered according to the Member s Benefit Plan and in accordance with applicable statutes and regulations. OptumRx is able to accept secondary Claims electronically. Retroactive eligibility changes Eligibility under a Benefit Plan may change retroactively if: The Benefit Plan, Sponsor or OptumRx receives information that an individual is no longer a Member; The Member s policy/benefit contract has been terminated; The Member decides not to purchase continuation coverage; or The eligibility information received by OptumRx is later determined to be incorrect. As determined by CMS, with respect to Medicaid, Medicare Prescription Drug Plan (MA-PD) or Prescription Drug Plans (PDP). Covered entities are health plans, health care clearinghouses, and those health care providers who transmit any health data in connection with a transaction for which the Secretary of Health & Human Services has adopted a standard (known as standard transactions). Most Medicare Organization health care providers send electronic Claims to Medicare (they are standard transactions), making them covered health care providers (covered entities). If a Network Pharmacy Provider has submitted Claim(s) that are affected by a retroactive eligibility change, a Claim adjustment may be necessary. OptumRx pharmacy manual: 7th edition 20

21 Average wholesale price ( AWP ), and wholesale acquisition cost ( WAC ) AWP shall mean the average wholesale price of medication drugs or ancillary supplies, as applicable, as dispensed and as set forth in the latest edition of the Medi-Span Prescription Pricing Guide (with supplements) or any other nationally recognized pricing source selected by Administrator (the Pricing Source ), as updated at least monthly. With respect to the term * Average Wholesale Price or * AWP as used in any exhibit or rate sheet that establishes compensation to Company or a Pharmacy, such *Average Wholesale Price or *AWP is derived by Administrator s adjusting AWP as follows to account for the September 26, 2009, rollback of AWP implemented by Medi-Span ( AWP Rollback ): (1) Administrator shall adjust the Medi-Span AWP Pricing Information for each of the Affected NDCs to reflect the markup factors utilized by Medi-Span immediately prior to the AWP Rollback. Affected NDCs shall mean all NDCs with adjusted markup factors by the Pricing Source pursuant to the AWP Rollback. (2) New NDCs with markup factors used by the Pricing Source shall be adjusted by Administrator to reflect a markup factor of New NDCs shall mean those NDCs first issued and listed on the Medi-Span AWP Pricing Information after the effective date of the AWP Rollback. WAC shall mean the average wholesaler acquisition cost of a Covered Prescription Service based on the Medi-Span Prescription Pricing Guide (with supplements) or any other nationally recognized pricing source selected by Administrator (the Pricing Source ), as updated at least monthly. Claims rejecting for high dollar limit Some plans may elect to implement a high cost dollar limit *. If the claim rejects for this reason, please contact the Pharmacy Help Desk using the contact information provided in Section II of this pharmacy Manual. * Amounts vary by plan. Vacation supply Some plans may offer a one-time vacation override. Please contact the Pharmacy Help Desk using the contact information provided in Section II of this pharmacy Manual to determine if the member s plan will allow for an override. B. Required prescription information For each Claim for a covered drug filled and dispensed by a Network Pharmacy Provider for a covered Member, all related Network Pharmacy Providers are required to transmit the following information to OptumRx: NCPDP D.0 format billing transaction. The payer/billing specification sheet which details all of the requirements for submitting a Claim using the NCPDP D.0 format is referred to as the Payer Sheet. Several fields are marked as situational and they will require data as needed under the defined situation in the comment section. Claims submitted that are missing data in mandatory or required fields, or where data is required under situational conditions, will be rejected. OptumRx pharmacy manual: 7th edition 21

22 With the NCPDP D.0 format change being able to handle the exact metric decimal quantity correctly, you will no longer need to adjust the quantity by rounding prior to submitting Claims. All Claims submitted in D.0 format MUST use the PCN of 9999 (or 8888 if a wrap plan Member refer to ID card) and a submitted group. We have not provided specifications for the American National Standards Institute (ANSI) 837 format, as we believe that the NCPDP D.0 is the correct format to use for pharmacy dispensed non-drug items. Other non-prescription products and pharmacy-related supply items should also be billed using the NCPDP or D.0 format. Pharmacy service type (PST) & patient residence code (PRC) requirements Effective January 1, 2014, OptumRx will accept Patient Residence Code (PRC) 01 and Pharmacy Service Type (PST) of 01 on claims from Retail Pharmacies in support of the Centers for Medicare and Medicaid Services (CMS) memo titled 2014 Requirements for Coding Patient Residence and Pharmacy Service Type on Claims Transactions. Below is a table of the PRC that OptumRx will accept based on the patient setting applicable to each circumstance: Patient setting Appropriate codes Not specified PRC of 00 Home PRC of 01 Home infusion (HI) PRC of 01 and place of service (POS) of 12 Skilled nursing facility PRC of 02 For Medicare Part B use only Nursing facility/long-term care (LTC) PRC of 03 Submission clarification code (SCC) required if for short-cycle dispensing Assisted living facility (ALF) PRC of 04 Custodial care facility PRC of 05 For Medicare Part B use only Group home PRC of 06 Intermediate care facility/mentally rtrd (ICFMR) PRC of 09 Hospice PRC of 11 Correctional institution PRC of 15 The pharmacy is required to choose the appropriate PRC and PST based on the circumstance of the point of sale claim. It would not be acceptable for the pharmacy to default to any PRC or leave this field blank. Claims submitted without an appropriate PRC, POS or PST code may be rejected. C. Dispense as Written (DAW) OptumRx supports the NCPDP standard DAW codes. To ensure accurate reimbursement, always include the correct DAW code when you submit a Claim. Claims submitted to OptumRx with DAW codes of three through six (3 thru 6) or eight through nine (8 thru 9) will be adjudicated similarly to a DAW 0. If necessary, contact your software vendor for needed alterations to your pharmacy system. OptumRx pharmacy manual: 7th edition 22

23 DAW codes: DAW 0 NO DISPENSE AS WRITTEN (substitution allowed) (or no product selection indicated) Use the DAW 0 code when dispensing a generic drug; that is, when no party (i.e., neither Prescribing Physician, nor Pharmacist, nor Member) requests the branded version of a multi-source product. Use the DAW 0 code when dispensing a multi-source generic, even if the Prescribing Physician indicates the DAW code for the generic product and does not specify a manufacturer. Use the DAW 0 code when dispensing single-source brands (e.g., Crestor ), because generic substitution is not possible. DAW 1 PHYSICIAN writes DISPENSE AS WRITTEN Use when the Prescribing Physician specifies the branded version of a drug on the hard copy prescription or in the orally communicated instructions. If the Member requests a Brand Name Drug, and it is not a Prescribing Physician-initiated instruction, transmit the DAW 2 code. (See following instructions.) DAW 2 PATIENT REQUESTED Use this code when the Member requests the Brand Name Drug even though the original prescription did not indicate DISPENSE AS WRITTEN. DAW 3 PHARMACIST SELECTED BRAND DAW 4 GENERIC NOT IN STOCK DAW 5 BRAND DISPENSED, PRICED AS GENERIC Use when dispensing a brand as a generic. Claims submitted with DAW 5 will be reimbursed at the generic price. DAW 6 OVERRIDE DAW 7 SUBSTITUTION NOT ALLOWED; BRAND MANDATED BY LAW DAW 8 GENERIC NOT AVAILABLE DAW 9 OTHER Please note: Most Members have a choice between Brand Name and Generic Drugs. However, in some programs the Member will pay the difference between the cost of the Brand Name Drug and the available Generic Drug. Accordingly, correct DAW submissions indicate if a penalty is applicable. D. Electronic remittance advice (ERA) 835 program OptumRx network pharmacy providers have the option to participate in the Electronic Remittance Advice (ERA) 835 program. This service provides improved analysis, reporting, and a cost-effective alternative to the traditional hard copy. OptumRx pharmacy manual: 7th edition 23

24 Enrollment requirements To use the OptumRx pharmacy ERA program, you must meet the following requirements: Be a current OptumRx network pharmacy provider. Have the ability to receive and read the Electronic Remittance Advice (ERA) 835 file. Check with your Information Technology support staff or pharmacy software provider to confirm that you have the ability to receive the encrypted claims information via File Transfer Protocol (FTP). The Centers for Medicare and Medicaid Services (CMS) also offer free software to view and print the Electronic Remittance Advice (ERA) 835 file for professional providers and suppliers. For more information on this software, Medicare Remit Easy Print (MREP), please access the CMS website at: cms.hhs.gov/. When converting from a paper remittance advice to an ERA, the paper remittance advice can be mailed to you upon your request. This can be done for up to thirty one (31) days once you are enrolled in the EFT payment process. Complete the Pharmacy ERA paper enrollment form containing your contact and banking information. Please allow four weeks for your enrollment to be processed. Claims received after your Pharmacy EFT enrollment has been processed will be paid electronically. Please see a copy of the ERA Enrollment Form attached as Exhibit A. Complete the server information section on the enrollment form. To complete the server information you will need to provide your PGP Key. This ensures the delivery of secure data. PGP (Pretty Good Privacy) Encryption is a computer program that provides cryptographic privacy and authentication. PGP and similar products follow the Open PGP standard for encrypting and decrypting data. You will need to get this information from your software vendor. Enrollment steps Follow these simple steps to enroll in the OptumRx pharmacy ERA program: Print, complete and return the enrollment form via fax or U.S. Mail to OptumRx. or Click on the online link (optumrx.com/rxsolhcpweb/cmscontent.do?pageurl=/hcp/healthcareprovidertools/ PharmacyERA) to complete the form online. This form will be used to set up the Electronic Remittance Advice (ERA) 835 file transfer. To Make Changes to or Cancel Your ERA Information: Print and complete the enrollment form. Be sure to circle Change or Cancel on the form. Return the form via fax or U.S. Mail to OptumRx. or Call the OptumRx Pharmacy HelpDesk at Completed forms may be returned via mail or fax: OptumRx P.O. Box 6104 Cypress, CA Fax: Once you are enrolled in the ERA program, you can call the Pharmacy Help Desk at if you have questions about a late or missing ERA. OptumRx pharmacy manual: 7th edition 24

25 E. Electronic funds transfer (EFT) program OptumRx network pharmacy providers have the option to participate in the electronic funds transfer (EFT) program. This service provides improved analysis, reporting, and a cost-effective alternative to the traditional hard copy process. Enrollment requirements To use the OptumRx Pharmacy EFT Program, you must meet the following requirements: Be a current OptumRx Network Pharmacy Provider. Be a current recipient of the Electronic Remittance Advice (ERA) 835. Complete the Pharmacy EFT enrollment form containing contract and banking information. Please allow four (4) weeks for your enrollment to be processed. Claims received after your Pharmacy EFT enrollment has been processed will be paid electronically. Please see a copy of the EFT Enrollment Form attached as Exhibit B. Enrollment steps Follow the simple steps located at the following to enroll in the OptumRx Pharmacy EFT Program: optumrx.com/rxsolhcpweb/cmscontent.do?pageurl=/hcp/healthcareprovidertools/ PharmacyEFT To Make Changes to or Cancel Your EFT Information: Print and complete the enrollment form. Be sure to circle Change or Cancel on the form. Return the form via fax or U.S. Mail to OptumRx to: or OptumRx P.O. Box 6104 Cypress, CA Fax: Call the OptumRx Pharmacy Help Desk at Once you are enrolled in the EFT program the Help Desk at , help is also available if you have questions about a late or missing EFT. Important changes to your EFT and ERA transactions Section 1104 of the Affordable Care Act includes an industry mandate for the use of operating rules for the handling of EFT and ERA transactions. Implementation of the operating rules must be complete by January 1, The operating rules for EFT require the adoption of the CCD+ and the X TR3 TRN Segment as the health care EFT standard. These standards must be used for electronic claims payment initiation by all PBMs that conduct health care EFT. The ERA must be provided in the v5010 X structure. OptumRx pharmacy manual: 7th edition 25

26 Industry research groups identified a significant issue for pharmacies when matching the EFT to the ERA because they each travel separately to the pharmacy. The reassociation of the EFT to the ERA is being solved by the inclusion of a reassociation trace number. The same reassociation trace number will appear in designated fields on the EFT and ERA file. The table below displays the minimum data elements from the CCD+ (EFT) for successful reassociation of the EFT payment with the corresponding v5010 X (ERA). Focus of this rule CORE-required minimum CCD+ Reassociation data elements 10 CCD+ Field # Field name (See 6 glossary for definition record # of these terms) Table Information only Corresponding v5010 X data elements Data element segment position, number & name 5 9 Effective entry date BPR date (EFT effective date) 6 6 Amount BPR monetary amount (tool actual provider payment amount) 7 3 Payment-related information TRN reassociation trace number segment, specifically data elements: TRN trace type code Required TRN reference identification Required (EFT trace number ) TRN originating company identifier Required (payer identifier) TRN reference identification Required (originating company supplemental code) Pharmacies must contact their financial institution to arrange for the delivery of the CORE-required Minimum CCD+ Data Elements necessary for the successful reassociation of the EFT payment with the ERA remittance. Once the financial institution delivers the data elements above, pharmacies will be able to easily match the Reassociation Trace Number provided in the EFT to the Reassociation Trace Number in the ERA. Please note: Once you are enrolled in the OptumRx Pharmacy EFT program, a paper remittance can be mailed for 31 days after your conversion, but you must request it. Electronic Remittance Advice (ERA) 835s will be delivered to pharmacy or payee via OptumRx external client Gateway. File can either be sent via Secure FTP or they can be retrieved from the Gateway. Files cannot be delivered in any other method (e.g., compact disk (CD), , etc.). The link above also contains instructions to cancel or make changes once enrolled in the OptumRx Pharmacy EFT Program. OptumRx pharmacy manual: 7th edition 26

27 F. Member/insured appeals and grievances OptumRx has established mechanisms to ensure all Members and Prescribing Physicians have equal access to, and can fully participate in, the Appeals process. Either the Member or the Member s appointed representative and/or Physician can initiate an appeal. Members should refer to the denial letter for information regarding their appeal and grievances. Member complaints or grievances are a means of continually improving the quality of our services. Grievances requested as directed above will be handled in a timely manner. Please note: Community and State (C&S) and Medicare and Retirement (M&R) handle their own appeals and grievances. Network contracting provider responsibilities The Network Pharmacy Provider will assist, as requested by the Benefit Plan or Sponsor or OptumRx on behalf of a Client, in processing Member grievances and Appeals, consistent with the Benefit Plan s or Sponsor s appeals and grievances procedures. If the Network Pharmacy Provider receives an Appeal or a complaint/grievance from a Member, the Network Pharmacy Provider should redirect the Member to call the Customer Service number listed on his or her Member ID card. G. Utilization management Utilization management requirements for select drugs Some covered medications may have additional requirements or limits that help ensure safe and effective use. Requirements and limits may include: Prior authorization (PA). Select medications may have potential for inappropriate or unsafe use. Therefore, sponsor approval is required to ensure that the medication will be used for indications for which it has been shown to be safe and effective. Medications requiring PA may require confirmation of diagnosis or submission of laboratory and other supporting information. Step therapy (ST). Step therapy promotes the use of safe and cost-effective alternatives prior to receiving approval for the requested medication. The recommended alternatives are considered preferred or first-line medications that are consistent with standard medical care and evidence-based literature. Once members have tried the alternatives without success, the requested medications requiring ST will be approved for coverage. Quantity limits (QL). Quantity limits restrict the amount of medication a member can receive by identifying a maximum quantity that can be dispensed over a specific period of time or per prescription. These restrictions are in place to ensure safe use by preventing excessive dosage amounts or extended periods of therapy without clinical justification. It may also be used to promote dose optimization which encourages members to use the most appropriate strength based on their dosing regimen. Certain drugs may be approved for quantities above the limited amount, if proven to be medically necessary. Prior authorization (PA) review process. A medicare member, member s appointed respresentative and/or a Prescribing Physician may submit a request to initiate the PA review process. Coverage determinations made through the PA review process will be based on Benefit Plan s/client s approved criteria, clinical guidelines approved by the National OptumRx pharmacy manual: 7th edition 27

28 Pharmacy & Therapeutics Committee (National P&T), or other professionally recognized standards of practice. If a Member s medication has step therapy or quantity limit restrictions, or requires prior authorization (PA), the Member or his/her appointed representative should contact OptumRx customer service number located on the back of the Member s ID card. In addition, the prescribing physician may contact our PA Department to start the prior authorization process by providing relevant, patient-specific clinical information to be reviewed by a licensed pharmacist or medical director. Prescribers can also submit a PA request via fax, mail, or online at: optumrx.com/rxsolhcpweb/tools/prior_auth/authorization_request_form_first. html?frmpastptherdrg=true Please note: The only C&S members currently able to submit PA requests online are for Kansas. Our PA process includes the following key steps: The Prescriber Member or Member s appointed representative can submit a PA request (see exceptions above). A pharmacy technician enters the information into our PA system and performs the initial request review. If the request falls outside the established guidelines, a pharmacist reviews the request and contacts the prescriber if additional information is required. If required by state law, the request will be reviewed by a medical director before issuing the final decision. Additionally, where required by law, the prescriber is offered the opportunity for a peer-to-peer consultation prior to the issuance of an adverse medical necessity determination. Once the request is approved or denied, our PA system will automatically generate a written correspondence to both the Member and provider. We comply with all State and Federal regulations for PA turnaround time. Our typical turnaround times are as follows: Non-urgent cases have a turnaround time of fifteen (15) days for commercial Benefit Plans, or seventy-two (72) hours for Medicare Benefit Plans from receipt of all information required to review the case. Urgent cases have a turnaround time of seventy-two (72) hours for commercial Benefit Plans, or twenty-four (24) hours for Medicare Benefit Plans from receipt of all information needed to review the case. Additional information: Our PA department is staffed with licensed pharmacists and pharmacy technicians. They also have access to a contracted physician reviewer when required. After PA requests are reviewed, determinations are rendered in accordance with State and Federal regulations, independent body accreditation standards, such as National Committee for Quality Assurance (NCQA), or Employee Retirement Income Security Act (ERISA), and the clinical guidelines developed by our National Pharmacy and Therapeutic (NP&T) guideline subcommittee. The Prescriber and Member or authorized representative will be notified of the final decision within the required time frame according to State and Federal regulations. H. Concurrent drug utilization review ( cdur ) In order to detect and address clinical quality and safety issues, certain Concurrent Drug Utilization Reviews (cdurs), or clinical edits, are applied at the time the prescription is dispensed. Concurrent screenings are for such things as duplicate therapies, age- or gender-related contraindications, overutilization or underutilization, drug-drug interactions, incorrect drug dosage or duration of drug therapy, drug-allergy contraindications, and clinical abuse or misuse. System thresholds/criteria and accompanying pharmacy messaging are developed and set by Medi-Span and are validated and implemented by OptumRx. Certain clinical edits are set up as messages or rejects depending on the clients cdur program setup. Dispensing pharmacists should exercise their clinical knowledge and expertise in reviewing and overriding warning messages if deemed medically appropriate. OptumRx pharmacy manual: 7th edition 28

29 Override codes for pharmacy Certain clients have allowable overrides for clinical edits. OptumRx also utilizes NCPDP defined DUR/Pharmacy Payment Service (PPS) Coding (Conflict, Intervention and Outcomes Codes) and Submission Clarification Codes. This set up applies to all UnitedHealth Group Clients. The following edits are SOFT REJECT edits, where the claim is rejected but pharmacists will be able to review and override certain DUR rejections/interactions by identifying and entering the appropriate conflict, intervention and outcome codes for each component. Edit name (abbreviation) Drug-drug interaction (DDI) drug therapy monitoring system (DTMS) Screening: reject 88 Dosing screening (DOSECHEK): reject 88 Description of edit DUR/PPS coding and submission clarification codes Checks member s prescription history to detect possible adverse interactions between submitted drug and others being taken by the member. Compares dosage of submitted drug with the maximum recommended dosage for member s age to detect possible conflict. Pharmacists review the patient profile to identify why the reject has occurred, consult with the prescriber, determine if the drug should be dispensed and if appropriate, override the rejection with the following DUR/PPS coding: Drug conflict code Reason for service code ( conflict code ) = DD for drug-drug Interaction DUR intervention code Professional service code ( intervention code ) = M0 for prescriber consulted = R0 for pharmacist consulted (commercial only) or = P0 for patient consulted (commercial only) DUR outcome code Result of service code ( outcome code ) = 1G for filled, with prescriber approval Pharmacists review the patient profile to identify why the reject has occurred, consult with the prescriber, determine if the drug should be dispensed and if appropriate, override the rejection with the following DUR/PPS coding: Drug conflict code Reason for service code ( conflict code ) = HD for high dose alert DUR intervention code Professional service code ( intervention code ) = M0 for prescriber consulted = R0 for pharmacist consulted (commercial only) or = P0 for patient consulted (commercial only) DUR outcome code Result of service code ( outcome code ) = 1G for filled, with prescriber approval = 1B for filled prescription as is OptumRx pharmacy manual: 7th edition 29

30 Too soon: reject 79 Checks member s prescription history to detect possible duplicate prescriptions. Pharmacists review the patient profile to identify why the reject has occurred, consult with the prescriber, determine if the drug should be dispensed and if appropriate, override the rejection with the following submission clarification codes (420-DK) ** : 03 Vacation supply The pharmacist is indicating that the cardholder has requested a vacation supply of medicine. 04 Lost prescription The pharmacist is indicating that the cardholder has requested a replacement of medication that has been lost. 05 Therapy change The pharmacist is indicating that the physician has determined that a change in therapy was required: either that the medication was used faster than expected, or a different dosage form is needed, etc. Please note: the use of each submission clarification code for the purpose of overriding the rejection is based on benefit design. Therefore if the benefit does not allow Vacation override, for example, submission clarification code 03 (corresponding to vacation supply) will not override the rejection. Likewise, if the benefit does not cover lost prescription, submission clarification code 04 (corresponding to lost prescription) will not override the rejection. I. Retrospective drug utilization review ( rdur )/clinical programs The Retrospective Drug Utilization Review (rdur)/clinical Program uses detailed data review and analysis to identify potential problems, implement appropriate interventions, and evaluate the impact of the interventions. rdur programs can yield measurable results, including reduction in emergency room visits, unnecessary and inappropriate drug use, and overall costs. The program s focus on pre-catastrophic populations with high-cost and high-impact conditions that have the greatest potential for improvement via Member and/or provider interventions. Specific program objectives include optimizing the use of certain therapeutic agents to improve health outcomes, reducing the risk for drug-related adverse events, and promoting the use of the most cost-effective medications. rdur program examples include, but are not limited to, the following: Drug-drug interaction alert program (DDIAP) Some medications can have harmful effects when used in conjunction with others. These potentially dangerous drug-drug interactions (DDIs) can negatively impact members health and increase both prescription and medical plan costs. The Drug-Drug Interaction Alert Program (DDIAP) helps to protect members from potential drug-related adverse events by notifying providers when a clinically significant DDI has been identified. Pharmacy claims are reviewed daily to detect clinically significant DDIs which are categorized as a combination of drugs that should always be avoided, or a combination that should usually be avoided. When members who filled medications with potentially serious DDIs are identified, their providers receive a faxed letter and report within twenty-four (24) to seventy-two (72) hours. Each report provides details on the clinically significant DDIs found for Members under the specific provider s care. Geriatric RxMonitor program Certain medications are not recommended for use by people age 65 years and older because of potential side effects or lack of effectiveness. Through the Geriatric RxMonitor Program, pharmacy plans can reduce the use of these potentially inappropriate medications among elderly members while improving quality of care. Using pharmacy claims data, we identify members who are at least sixty-five (65) years old and have filled one or more high-risk medications that should be avoided in the elderly (high-risk medications are determined based on applicable Health Plan Employer Data and OptumRx pharmacy manual: 7th edition 30

31 Information Set (HEDIS criteria). Providers receive a mailing containing an introductory letter, a provider-specific report of identified members, information about medication therapy management options and educational materials. In some cases, members may also receive an educational mailing. Narcotic drug utilization review program While opioid analgesics, benzodiazepines, muscle relaxants, and acetaminophen (APAP)-containing medications are an important part in managing pain and other medical conditions for many patients, these medications are often associated with addiction, dependence and tolerance. The Narcotic Drug Utilization Review Program identifies members who may benefit from having their medication regimens re-evaluated by their health care providers. This program improves the quality of patient care by reducing potentially inappropriate usage of opioids, benzodiazepines, muscle relaxants, and APAP-containing medications. We retrospectively review and analyze pharmacy claims data to identify members who meet at least one (1) criteria: overlapping use of different long-acting opioid medications; multiple providers prescribing opioids, benzodiazepines, or muscle relaxants; multiple pharmacies dispensing opioids, benzodiazepines, or muscle relaxants; high doses of opioids; chronic early refills of oxycodone-containing products; excessive days supply of opioids; and total average daily APAP dose exceeding four (4) grams. Providers receive a mailing containing an introductory letter, a provider specific report of identified members and educational materials. Opioid overutilization drug utilization review (DUR) program The Centers for Medicare and Medicaid Services (CMS) requires all Part D sponsors implement an Opioid Drug Utilization Review (DUR) program to better address potential overutilization of opioids in their prescription drug benefit plans through improved drug utilization controls and member-level case management. The goal of the CMS Opioid program is to identify and case-manage members with excessive use of opioid medications considered to be potentially unsafe, and to reduce fraud, waste and abuse in Part D programs. Members identified as receiving a relatively high dose of opioid medications for a long period of time and receiving these opioid medications from multiple prescribers and pharmacies will have a case manager assigned to conduct physician outreach to confirm if the current dosage of opioids is medically necessary and safe for each member. Based on the results of this retrospective review, a member-level point of sale (POS) edit may be implemented limiting the use of opioids for member safety. Not all members will have a POS edit implemented. Members receiving an opioid restriction will be notified 30 days in advance of the effective date of the restriction to provide time for a coverage determination to be processed. Polypharmacy program Unnecessary or duplicate use of medications, also known as polypharmacy, can lead to serious health complications for members, as well as increased pharmacy and medical costs. To lower the health risks associated with polypharmacy, we offer actionable, provider-based interventions designed to reduce polypharmacy issues. There are two (2) distinct Polypharmacy Programs to identify the following issues: The Duplicate Therapy Program uses pharmacy claims data to identify members taking two (2) or more duplicate medications (i.e., medications with duplicate therapeutic effects and intended to treat the same condition). The Drug-Disease Interaction Program uses pharmacy and/or medical claims data to identify members taking medications that may adversely interact with their existing medical conditions. For both Polypharmacy Programs, providers receive a mailing containing an introductory letter and a report with information they can use to assess their patients polypharmacy issues. OptumRx pharmacy manual: 7th edition 31

32 Generic strategy program The OptumRx Generic Strategy Program is designed to promote the use of clinically appropriate lower-cost generic medications. The program targets newly available and existing generic medications in select therapeutic classes. These classes include, but are not limited to: Angiotensin receptor blockers (ARBs) Bisphosphonates Nasal steroids Proton pump inhibitors (PPIs) Statins Triptans Members will receive letters regarding: Availability of the generic equivalent and alternative medications Safety and efficacy of generic products Cost savings associated with generic products In addition, network providers will receive letters containing the following: Availability of the generic equivalent and alternative medications Safety and efficacy of generic products Cost savings associated with generic products A list of their identified patients who would benefit from switching from brand medications to generic alternatives Maximum dollar edits ( Max ) Claims rejecting for maximum dollar exceeded can be addressed by calling the OptumRx Pharmacy Help Desk using the contact information provided in Section II of this pharmacy Manual. J. MAC review requests OptumRx has implemented a MAC review process that extends the opportunity for participating pharmacies to submit specific claims for review of reimbursement on generic items paid via our MAC pricing list as described in network reimbursement terms of applicable contract addendums. Review requests submitted via the appropriate and approved form (supplied by the OptumRx Pharmacy Network Contracting Department) will be reviewed and responded to in the order received. OptumRx will make every effort to provide a response within 45 (forty-five) business days from the date the review request was successfully submitted on the appropriate form. Review requests will be reviewed to determine the appropriateness of pricing utilized by OptumRx for reimbursement. OptumRx will utilize all available information to deduce the appropriateness of reimbursement. Participating pharmacies must submit their actual acquisition cost (including any rebates) for each item being reviewed. Failure to submit the actual acquisition cost (including rebates) will not result in OptumRx rejecting claims for review, but could diminish the accuracy of review and therefore the likelihood of a successful and complete review. Please contact the Pharmacy Network Contracting Department using the contact information provided in Section II of this pharmacy Manual for more information or to request the form. For MAC review requests only: address: [email protected] OptumRx pharmacy manual: 7th edition 32

33 Exit Previous Next Back Contents V. Products OptumRx pharmacy manual: 7th edition 33

34 As of the date of publication of this pharmacy Manual, the following is a list of the Clients/Sponsors that OptumRx currently serves and their respective Claims processing information: Claims processing information (Note: This list is a sample of some of the 2014 Clients and related processing information and is not meant to be an all-inclusive list). Please contact the Pharmacy Help Desk using the contact information provided in section II of this pharmacy Manual for more information. Required submitted Client / plan name BIN PCN Group Part D and MA-PD plans AMCNJ, AMCTN, COS, BER, GSM, MPDACU, MPDACUAZ, MPDACUNY, MPDACUWI, PDPIND, PIB, PSR, SHAZ, SHCA, SHCO, SHNV, SHOK, SHOR, SHII, SHTX, SHWA, SIE, PDPIND Part D WRAP plans WRAPGR, COS, SHCA, NYCTA 9999 UHEALTH, UHC, OXFRDHP, SRS, UNEVADA, UnitedHealthcare commercial plans UHHP, UVALLEY, NIKE ACUAZ,, ACUFL, ACUMI, ACUNY, ACUOH, ACUPA, ACURI, ACUTX, ACUWA, AMNE, 9999 AMNJ, AOC, BHW24, FOX, FRU, HAWKI, JSN, Commercial and medicaid L301, NCT, OND, PRXDBC, PRXJSL, PRXPHK, PRXTRV, PRXUMK, PUL, SCEET, SLC, SLL, SRPLH, STS, TOC, UHC, VOC, VOP, SHCA, COS PartnersRx PartnersRx coupons PRX1000 PRX PRX2000 Community health HealthESystems Not Not required Required Legacy innoviant commercial , , COSF, GASF, MASF, NCCSI, NCSF, SCCSI, SCSF Raytheon COB , , RETA trust Refer to RETA OptumRx pharmacy manual: 7th edition 34

35 VI. Medicare product information and guidelines OptumRx pharmacy manual: 7th edition 35

36 Excluded drugs As of the date of the printing of this Manual, certain types of drugs or categories of drugs are not normally covered by Medicare Prescription Drug Plans. These drugs are not considered medicare Part D (Part D) drugs and may be referred to as exclusions or non-part D drugs. The following are drug classes or categories of drugs excluded from Part D coverage with examples of drugs within each class. Prescription vitamins and mineral products, with the exception of formulary prenatal vitamins and fluoride preparations. Examples: Ascorbic Acid, Folic Acid, Vitamin B Agents when used for anorexia, weight loss, or weight gain. Examples: Ionamin, Meridia, Phentermine Agents when used to promote fertility. Examples: Clomiphene Citrate, Fertinex, Follistim, Gonal-F, Serophene Agents when used for cosmetic purposes or hair growth. Examples: Botox Cosmetic, Eldoquin, Hydroquinone, Lustra, Propecia, Renova Agents when used for the symptomatic relief of cough and colds. Examples: Benzonatate, Tessalon Nonprescription or over-the-counter drugs (with the exception of Insulin and associated medical supplies). Examples: Aspirin, Sudafed, Tylenol Less-Than-Effective Medicaid Drug Efficacy Study Implementation (DESI) Drugs. Examples: Anucort HC, Tigan Suppositories Agents when used for the treatment of sexual or erectile dysfunction. Examples: Viagra, Cialis, Levitra and Caverject Outpatient drugs for which the manufacturer seeks to require that associated tests or monitoring services be purchased exclusively from the manufacturer as a condition of sale. End-Stage Renal Disease (ESRD) agents furnished to ESRD patients on dialysis. Examples: Iron, Vancomycin, Daptomycin Agents without New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) with the Food and Drug Administration (FDA). Agents that are not discounted for Medicare beneficiaries in the coverage gap. Pain medications furnished to Hospice patients. Compounds that contain at least one ingredient covered under Medicare Part B. Bulk ingredients/powders used in compounds. Self-administered oral anti-cancer agents with the same active ingredients and indications as chemotherapy agents administered as incident to a physician s professional service. Examples: Temodar, Xeloda OptumRx pharmacy manual: 7th edition 36

37 Many of the benefit plans we support may cover Medicare Part D-excluded drugs through enhanced coverage. For more information, please contact Customer Service at the phone number provided on the back of the Member s ID card. Medicare Part A/B/D coordination of benefits Some drugs may be billed to either the Medicare Part A (if a Member is an inpatient), Part B or Part D benefit, depending on the intended use and other factors. Medications may be covered in one (1) of three (3) ways: Under Medicare Part A if Member is an inpatient; or Under Medicare Part B; or The Medicare Prescription Drug Plan (PDP) in conjunction with Medicare Part D. Medications will never be covered through Medicare Parts A, B and the Medicare Part D Prescription Drug Plan at the same time. Online messaging, e.g., COVERED UNDER PART B, BILL MEDICARE, is provided at the point of service. When it is not clear which coverage applies, the prior authorization process should be initiated in order to determine the appropriate coverage. MAPD Plan claim responses will have benefit stage qualifier values that have been approved through the NCPDP External Code List (ECL) process. These qualifier values will allow pharmacies to identify Medicare MAPD Plans that offer additional benefits besides Part D covered drugs: The Medicare Advantage (MA) portion of the MAPD Plan = Benefit Stage Qualifier (393-MV) value of 50 (Not paid under Part D, paid under Part C benefit (for MAPD Plan). Employer Group Waiver Plans (EGWPs) and supplement plans where Part D and non-part D supplemental benefits are co-administered = Benefit Stage Qualifier (393-MV) value of 60 (Not paid under Part D, paid as or under a supplemental benefit only). Negotiated Price Non-formulary Part D drug = Benefit Stage Qualifier (393-MV) value of 70 (Part D drug not paid by Part D plan benefit, paid by the beneficiary under plan-sponsored negotiated pricing). Negotiated Price Non-Part D Drug = Benefit Stage Qualifier (393-MV) value of 80 (Non-Part D drug not paid by Part D plan benefit, paid by the beneficiary under plan-sponsored negotiated pricing). These benefit stage qualifiers are not applicable to standalone MA plans and PDP plans, these plans will have separate 4Rx since they may be sold independently (a beneficiary can choose to use one Company s MA and another Company s Prescription Drug Plan (PDP). Medicare Part D coverage determinations Coverage determinations allow requests for exceptions to waive coverage restrictions or limits applied through prior authorization, step-therapy, quantity limits, and Medicare Part A/B/Part D coordination of benefits. The Member, Member s Authorized Representative, Prescribing Physician or other Authorized Prescriber may request an exception. If the Benefit Plan or Sponsor approves an exception request, the approval is valid for the remainder of the plan year, unless clinically inappropriate or unnecessary, so long as the prescribing physician continues to prescribe the medication and it continues to be clinically appropriate and necessary, safe and effective for treating the Member s condition. If the exception request results in an adverse coverage determination, a Member may appeal the decision. OptumRx pharmacy manual: 7th edition 37

38 Time frames Standard coverage determination requests are generally provided within seventy-two (72) hours of receipt of the request, or, for an exceptions request, 72 hours after receipt of the physician s supporting statement. If the Benefit Plan or Sponsor has not provided an answer within 722 hours after receiving a request, or, for an exceptions request, 72 hours after receipt of the physician s supporting statement, the request will be automatically forwarded to an independent organization called an Independent Review Entity (IRE) for review. Expedited coverage determinations are provided no later than twenty-four (24) hours of receipt of the request, or, for an exceptions request, 24 hours after receipt of the physician s supporting statement. If the Benefit Plan or Sponsor has not provided an answer within 24 hours after receiving a request, or, for an exceptions request, 24 hours after receipt of the physician s supporting statement, the request will be automatically forwarded to an independent organization called an Independent Review Entity (IRE) for review. Coverage limitations A prescription drug is a Medicare Part D drug only if it is for a medically accepted indication as defined in the Medicare regulations and implementing guidance. This definition includes prescribed uses supported by a citation included, or approved for inclusion, in one (1) of the following three (3) compendia: American Hospital Formulary Service Drug Information United States Pharmacopeia Drug Information or its successor publication DRUGDEX Information System National Comprehensive Cancer Network (NCCN) Based on this regulatory definition, indications supported in peer reviewed medical literature are not medically accepted if they are not yet included, or approved for inclusion, in one of the compendia. Therefore, the use of a medication for such indications would not meet the definition of a Medicare Part D medication and the medication would not be covered under the Benefit Plan, even if the Member s prescribing physician states that the medication is medically necessary. The following additional coverage limitations may apply: Early refills for lost, stolen or destroyed medications are not covered except during a declared National Emergency. Early refills for vacation supplies may be limited to a one (1) time fill of up to thirty-one (31) days per calendar year according to Benefit Plan. Medications will not be covered if prescribed by physicians or other providers who are excluded from Medicare program participation (unless they have an approved waiver on file with the OIG. These occurrences are very rare). A Member may refill most prescriptions when a minimum of seventy-five percent (75%) of the quantity is consumed based on the number of days supplied. This minimum quantity consumed amount is seventy percent (70%) for eye drops. Medication therapy management (MTM) program Consistent with the Medicare Modernization Act (MMA) requirements for Medication Therapy Management (MTM) Programs, the Benefit Plan provides an MTM Program at no additional cost for eligible plan Members. This program is designed to ensure that Members get the most medically appropriate, safe and cost effective medications. It focuses on improving medication use and reducing adverse drug events. OptumRx pharmacy manual: 7th edition 38

39 Eligibility CCMS requires that MTM Programs be offered to Members who have multiple chronic diseases, take multiple chronic/ maintenance Medicare Part D covered medications, and are likely to incur annual costs of $3,017 for covered Medicare Part D medications. Each plan is to define the number and type of chronic diseases and number of Medicare Part D medications to include in the MTM Program. The criteria selected for the OptumRx MTM program are: 1. A Member must have at least three (3) of the following target chronic diseases: a. Hypertension b. Chronic heart failure c. Diabetes d. Dyslipidemia e. Osteoporosis f. Rheumatoid arthritis (targeted disease is plan specific) 2. A member must have filled prescriptions for at least eight (8) distinct Medicare Part D covered chronic/maintenance medications during the identification period. 3. A member must be identified as likely to incur annual costs of $3,017 for Medicare Part D covered medications. The benefit plan identifies and invites Medicare Part D plan members who meet the criteria to take part in the MTM program. Scope of MTM program services The scope of the MTM Program services is determined by each plan. In selecting MTM Program services, OptumRx complies with all Centers for Medicare and Medicaid Services (CMS) regulations and also considers the potential impact of each service on maximizing therapeutic outcomes. Therefore, the selected services exemplify the best practices stated in the MMA and can potentially impact clinical outcomes. The MTM Program includes, but is not limited to: Providing patient and physician education. Performing an annual comprehensive medication review which consists of telephonic, interactive, person-to-person consultation with a pharmacist and individualized written summary with action plan and recommendations. Performing quarterly targeted medication reviews on an ongoing basis. Reimbursement As of the date of the printing of this Manual, OptumRx is solely responsible for designing, developing and implementing MTM Program-related clinical services on behalf of its clients. Therefore, there are no plans for reimbursement to health care providers at this time. Enrollment process The MTM Program is offered at no cost to Members. Members who do not want to participate may opt out of the entire MTMP or any of its components. OptumRx reviews the available medical and pharmacy claims data to determine MTMP eligibility. In the absence of medical claims data, a drug proxy tool may be used for verification of diagnosis. OptumRx pharmacy manual: 7th edition 39

40 Medicare Part D transition policy At the time an individual joins a Medicare Part D plan, a new member may be taking a medication that is either not on the benefit plan s formulary or is subject to benefit plan requirements or restrictions. If there are no appropriate alternative therapies on the Formulary, the Member or the physician may request a Formulary exception. During this review process, the Member may be eligible to receive a temporary transition supply of the medication. The maximum days supply allowed is a thirty-one (31) day supply (unless the prescription was written for fewer days) at any time during the first ninety (90) days of Membership in the Member s Medicare Part D Plan. The Benefit Plan or Sponsor provides notice to its Members and their prescriber who receive a transitional supply of a prescription drug. This notice is sent by U.S. mail within three (3) business days of the temporary fill. It includes: An explanation of the temporary nature of the transitional supply. Instructions for working with the Benefit Plan or Sponsor and the Prescriber to identify appropriate Formulary alternatives. An explanation of the Member s right to request an exception. A description of the procedures for requesting an exception. Please note: Not all transactions are automated and requesting an override may require you to contact the Pharmacy Help Desk using the contact information provided in Section II of this pharmacy Manual. Network Pharmacy Providers receive an electronic notice of a temporary transition fill at the Point of Sale (POS). If the exception is approved, the Member will be able to obtain the medication for a specified period of time. After the initial temporary transition supply of up to thirty-one (31) days, the Benefit Plan or Sponsor may not continue to pay for these medications under the transition policy. The Member should discuss appropriate alternative therapies on the Formulary with the Prescribing Physician. If there are no alternatives, the Member and physician may request a Formulary Exception. Medicare Part D transitioning long-term care (LTC) facility residents If the Member is a resident of a long-term care facility, the Benefit Plan or Sponsor will also cover a temporary transition supply. The maximum days supply allowed is a thirty-one (31) day supply (unless the prescription was written for fewer days) with refills provided; and if needed, at least a ninety-one (91) day supply and may be up to a ninety-eight (98) day supply (unless the prescription is written for fewer days) during the first ninety (90) days the individual is a Member of the Benefit Plan. If the Member needs a medication that is not on the Formulary or the Member s ability to get the medication is limited, but the individual has been a Member of the Benefit Plan for more than ninety (90) days, the Benefit Plan may cover a one (1) time, thirty-one (31) day supply of that medication (unless the prescription was written for fewer days) or an extension of the transition period, on a case-by-case basis, while the Member pursues a Formulary Exception. There may be unplanned transitions such as hospital discharges or level-of-care changes that occur after the first ninety (90) days that an individual is a Member of the Benefit Plan. If the Member is prescribed a drug that is not on the Formulary or the ability to get a drug is limited, the Member is required to use the Benefit Plan s Formulary Exception process. The Member may request a one (1) time emergency supply of up to thirty-one (31) days (unless the prescription is written for fewer days) to allow time to discuss alternative treatments with his or her physician or to pursue a Formulary Exception. OptumRx pharmacy manual: 7th edition 40

41 Long-term care facility information to be provided upon termination When a pharmacy provider no longer participates in the OptumRx Pharmacy Network, including, but not limited to, a voluntary or involuntary termination, pharmacy provider shall comply with the Benefit Plan s or Sponsor s transition of care policies and procedures. Within five (5) business days of the termination notice and upon request thereafter, pharmacy provider shall provide to Administrator a list of long-term care facilities with Members receiving Part D benefits through the Benefit Plan or Sponsor. The list shall contain i) Pharmacy Information, including Pharmacy Name, Pharmacy NCPDP #, Pharmacy Address, Long-Term Care Facility Name, Long-Term Care Facility Address and Long-Term Care Facility Phone Number and ii) a Member list by Facility, including each Member s Name, ID# and DOB. The Centers for Medicare & Medicaid Services (CMS) issued a final rule that calls for the dispensing of brand name drugs in 14-day-or-less increments to Medicare Part D members residing in long-term care (LTC) facilities. Short-cycle dispensing (SCD) processing for long-term care The centers for Medicare & Medicaid Services (CMS) issued a final rule that calls for the dispensing of brand name drugs in 14-day-or-less increments to Medicare Part D members residing in long-term care (LTC) facilities. The ruling seeks to reduce waste by minimizing unused drugs for the Medicare Part D program. Solid oral dosage brand drugs are the only formulations affected by this ruling. Antibiotics in all forms, prepackaged drugs and liquid drug formulations are exempt. Beginning in 2014, member cost sharing will be prorated based on the day supply. For example, if the member has a $30 copay for a 30-day supply, the member will pay $14 for a 14-day supply. When submitting claims that are subject to the short-cycle regulations, providers must ensure that all of the following fields are submitted: NCPDP field name NCPDP field ID Appropriate value for SCD claims Patient residence 384-4X 03 Submission clarification code 354-NX See below Pharmacy service type 147-U7 01,03,05 CMS qualified facility 997-G2 Y Special packaging indicator 429-DT See below Following are valid submission clarification code and special packaging indicator combinations Submission clarification code 1 Submission clarification code 2 Special packaging indicator Paid Paid Paid Paid Paid Paid Paid Paid Paid Outcome OptumRx pharmacy manual: 7th edition 41

42 Paid Paid Paid Paid Paid Paid Paid Paid Paid Paid Paid Paid Paid Paid Paid Paid Paid Paid Paid Paid Paid Paid Paid Paid Paid Paid Paid Paid Paid Paid Paid Paid Paid Paid Claims submitted with an invalid clarification code and special package indicator combination will be rejected with one of the following codes: 597 LTC dispensing type does not support packaging type 613 The packaging methodology or dispensing frequency is missing or inappropriate for LTC short-cycle OptumRx pharmacy manual: 7th edition 42

43 The following fields must be completed on the claim submission form: Patient qualification patient residence, place of service Provider qualification pharmacy service type Claim qualification submission clarification code, special packaging type The combination of values for these claim qualifications are defined by CMS and the National Council for Prescription Drug Programs (NCPDP) and are not user-definable. If an NCPDP defined combination is not submitted correctly by the pharmacy, the claim will be rejected with the 613 code. If the LTC has submitted the claim according to the above guidelines and receives a 597 code, then the LTC may resubmit the claim with Submission Clarification Code 21 and SPI 1 or 3 to bypass the edit. Daily cost share is a new CMS requirement, effective January 1, 2014 Effective January 1, 2014, pharmacies will be responsible for costs associated with erroneous claims. Please be sure to submit accurate claims with correct codes. The submission clarification codes for daily cost share for 2014 are 47 and : Overrides Refill Too Soon for prorated claims. 48: Overrides the next claim after the prorated claim that has a shortened supply to less days because of the prior claim. This change is in response to the Centers for Medicare & Medicaid Services requirement pursuant to 42 CFR section (b)(4)(i) that Part D sponsors apply a daily cost-sharing rate when certain prescriptions are dispensed by a network pharmacy for less than a 30-day supply. As a result, Part D plan sponsors will be able to apply a lower, prorated cost-sharing amount when the prescription is dispensed, which may: Lower costs to patients for trial fills for less than 30 days. Facilitate synchronization of prescriptions through reduced cost sharing. Reduce instances of unused medications. The daily cost share requirement applies to the first fills/refill synch and any fill of less than one month, unless the drug is one of the following exempt drugs: Antibiotics and drugs dispensed in their original container as indicated in the Food and Drug Administration prescribing information. Drugs dispensed in their original packaging to help patients with compliance. OptumRx pharmacy manual: 7th edition 43

44 Medicare Part D sixty (60) day negative formulary change notice Notice of Negative Formulary changes will be available online and disseminated periodically through fax broadcast to Network Pharmacy Providers sixty (60) days prior to the removal or adverse change in the preferred or tiered cost-sharing status of a Medicare Part D drug. In certain cases for Food and Drug Administration (FDA) market withdrawals, the notice may or may not be retrospective. The posting will include: The name of the affected covered Medicare Part D drug. Information on whether the covered Medicare Part D drug is being removed from the Formulary, or adversely changing its preferred or tiered cost-sharing status. The reason why the covered Medicare Part D drug is being removed from the Formulary, or changing its preferred or tiered cost-sharing status. Alternative drugs in the same therapeutic category, class or cost-sharing tier, and the expected cost sharing for that drug. The means by which Members may obtain an updated coverage determination or an exception to a coverage determination. Affected Members will also be notified in the Explanation of Benefits (EOB) about a Formulary change sixty (60) days before it takes effect. Changes to the 2014 Medicare Part D formulary, for the following plans, will be posted on the websites listed below (Note: This list is NOT all inclusive but a sample ONLY): Websites aarpmedicarecomplete.com ericksonadvantage.com teamstarpartd.com goldenstatemhp.com hopbenefits.com sierrahealthandlife.com uhccommunityplan.com symphonixhealth.com Plans AARP MedicareComplete AARP MedicareRx Enhanced AARP MedicareRx Preferred Erickson Advantage IBT (International Brotherhood of Teamsters) Golden State Medicare Health Plan PSERS (Pennsylvania Public School Educators Retirement System) Sierra MAPD Plan UnitedHealthcare Community Plan Symphonix Health Plan OptumRx pharmacy manual: 7th edition 44

45 Medicare Part D annual notice of change for continuing members Each fall, members receive a combined Annual Notice of Change (ANOC)/Evidence of Coverage (EOC) packet from their Benefit Plan Sponsor(s). Packet materials identify changes in the drug Benefit Plan for the coming year. Changes explained in the packet become effective January 1 and will apply through December 31 of the upcoming plan year. A Member may notice that a Formulary medication he or she is currently taking is either not on the upcoming year s Formulary, cost sharing has changed, or coverage is limited in the upcoming year. In this case, the Benefit Plan or Sponsor will work to prospectively transition current Members who are affected by negative Formulary changes in the new contract year. If the Member is unable to transition to another product prior to the new benefit year, the Member will be entitled to a one (1) time transition fill during the first ninety (90) days of the new benefit year. Inform members of advance directives The Federal Patient Self-Determination Act (PSDA) gives individuals the legal right to make choices about their medical care in an advance directive. Under the PSDA, physicians and providers including hospitals, skilled nursing facilities, hospices, home health agencies and others must provide written information to Members on State law about advance treatment directives, about Members right to accept or refuse treatment, and about Network Pharmacy Providers own policies regarding advance directives. To comply with this requirement, Benefit Plans or Sponsors also inform their respective Members of state laws on advance directives through Member handbooks and other communications. OptumRx encourages these discussions with Members presenting at a Network Pharmacy Provider for covered services. Provide timely notice of demographic changes A Network Pharmacy Provider must notify OptumRx of changes to demographic information that differs from the information reported with Agreement, including, but not limited to, tax identification (ID) changes, address changes, and new service locations within the timelines described in the Agreement. OptumRx pharmacy manual: 7th edition 45

46 VII. Other general terms and conditions OptumRx pharmacy manual: 7th edition 46

47 A. Compliance All Medicare Advantage Organizations, Part D sponsors, and Medicaid Managed Care Organizations are required to have developed a compliance plan that meets regulatory requirements (Chapter 42 of the Code of Federal Regulations, Parts 422 and 423) and that is reasonably designed, implemented and enforced so that it generally will be effective in preventing and detecting noncompliance with regulatory requirements, including program-specific (for example Medicare Part D) requirements and preventing and detecting potential criminal or fraudulent conduct. OptumRx has a compliance plan in place that is in alignment with Federal Sentencing Guidelines and that, among other things, supports the monitoring and detection of fraud, waste or abuse within federal programs. OptumRx and our client Medicare Advantage Organizations, Medicare Part D Sponsors, and Medicaid Managed Care Organization Compliance Plans include the following recommended elements around which our program has been built: 1. Written policies and procedures: Standards of conduct to assist employees, independent contractors, and agents to comply with applicable laws, including Medicare and Medicaid. 2. Compliance officer/compliance committee: Designation of a compliance officer and compliance committee. 3. Education and training: Education and training programs for appropriate Pharmacy employees that include among other things, the Network Pharmacy Provider s standards of conduct and ethical and compliance expectations. 4. Effective lines of communication: A process to report violations of the standard of conduct. 5. Monitoring and auditing: A system to monitor and audit activities within the Network Pharmacy Provider for compliance with applicable laws. 6. Enforcement and discipline: A system to respond to allegations of violations of the standard of conduct and procedures to enforce appropriate disciplinary action against employees, independent contractors and agents who have violated the standards of conduct. In addition, the Network Pharmacy Provider must have a system to monitor whether employees, independent contractors and agents have been sanctioned by the Medicare or Medicaid Programs upon hire and at least monthly. Network Pharmacy Providers should be aware that OptumRx and/or Benefit Plan Sponsors shall not pay for drugs provided by a Network Pharmacy Provider excluded by either the United States Department of Health and Human Services (HHS) OIG or General Services Administration (GSA) pursuant to 42 C.F.R. (Code of Federal Regulations) a. Pharmacies must check these lists upon hire and at least monthly to ensure employees working with Medicare business have not been excluded from Federal program participation. Pharmacy staff can check these lists by using the following links: OIG: oig.hhs.gov/fraud/exclusions.asp GSA: sam.gov/portal/public/sam/ 7. Responding to detected offenses and developing corrective action initiatives: A system to investigate allegations of noncompliant behavior by employees, independent contractors, or agents. Sponsors, first-tier and downstream entities (including Network Pharmacy Providers) should initiate an investigation immediately, but no less than 2 (two) weeks from the date that a potential fraud matter is identified. If, upon investigation, the Network Pharmacy Provider believes that potential misconduct has occurred, the Network Pharmacy Provider should report the alleged activity to the OptumRx Pharmacy Help Desk using the contact information provided in Section II of this pharmacy Manual. In addition, the Network Pharmacy Provider may report this information to any of the following: a. The customer services number identified on the back of a member s ID card. b. The Medicare integrity contractor (MEDIC) at SAFERX or OptumRx pharmacy manual: 7th edition 47

48 In addition, OptumRx and Benefit Plan Sponsors maintain files on Network Pharmacy Providers who have been the subject of complaints, investigations, violations and prosecutions. Upon notification of potential issues, OptumRx may request information regarding the corrective action initiatives implemented by the Network Pharmacy Provider to identify or prevent the identified misconduct from recurring. 8. Fraud, waste and abuse ( FWA ): A system to identify and prevent fraud, waste and abuse. OptumRx has a zero-tolerance policy on fraud, waste and abuse and will administer corrective action up to and including reclaim of the overpayments associated with FWA, and/or termination of the Agreement as warranted. Network Pharmacy Providers must comply with all applicable laws and rules concerning compliance with federal requirements. To obtain a copy of the CMS Fraud, Waste and Abuse and General Compliance Training Module please click on the link below. cms.gov/outreach-and-education/medicare-learning-network-mln/mlnproducts/providercompliance.html 9. Pharmacy provider marketing activity: CMS has issued instruction, including in the Medicare Marketing Guidelines Manual, on provider marketing activities. CMS is concerned with pharmacy provider marketing activities because pharmacy may not be fully aware of all plan benefits and costs, may confuse the beneficiary if the pharmacy is perceived as acting as an agent of the plan versus acting as the beneficiary s pharmacy provider and Pharmacy may face conflicting incentives when acting as a plan sponsor representative. Therefore, pharmacies are not permitted to specifically market any plan. To the extent that a pharmacy provider can assist a beneficiary in an objective assessment of his/her needs and potential options to meet those needs, they may do so. Therefore, a pharmacy may engage in discussions with beneficiaries, should a beneficiary seek advice. However, pharmacy must remain neutral when assisting with enrollment decisions and may NOT: Offer sales/appointment forms. Accept (including prepare and submit) Medicare enrollment applications. Make phone calls or direct, urge or attempt to persuade beneficiaries to enroll in a specific plan based on financial or any other interests of the provider. Mail marketing materials on behalf of plan sponsors. Offer anything of value to induce plan enrollees to select them as their provider. Offer inducements to persuade beneficiaries to enroll in a particular plan or organization. Conduct health screening as a marketing activity. Accept compensation directly or indirectly from the plan for beneficiary enrollment activities. Distribute materials/applications within an exam room setting. Providers MAY: Provide the names of plan sponsors with which they contract and/or participate. Provide information and assistance in applying for the LIS. Make available and/or distribute plan marketing materials. OptumRx pharmacy manual: 7th edition 48

49 Refer their patients to other sources of information, such as SHIPs, plan marketing representatives, their State Medicaid Office, local Social Security Office, CMS website at medicare.gov/ or MEDICARE. Share information with patients from CMS website, including the Medicare and You Handbook or Medicare Options Compare (from medicare.gov), or other documents that were written by or previously approved by CMS. As a result of the above, it is important that pharmacy establish appropriate consent from Members or their authorized representatives before engaging in permissible marketing activities. Pharmacy should also only provide such assistance with beneficiaries present (in-person) to avoid misunderstandings. B. Pharmacy fraud, waste and abuse and general compliance training An important part of the Medicare program is controlling fraud, waste and abuse (FWA). For this reason, the Centers for Medicare & Medicaid Services (CMS) has required that all Medicare Advantage Organization and Part D Sponsors require fraud, waste and abuse and general compliance training with their first-tier, related, and downstream (FDR) contracted entities. On behalf of all of our Medicare Advantage Organizations and Medicare Part D sponsors, we are providing this training to all of our pharmacy provider partners. Please see the link below to review instructions for completing the training and complying with other compliance requirements. optumrx.com/vgnlive/hcp/assets/pdf/fraud%20waste%20abuse%202013%20attestation%20requirement.pdf Network Pharmacy Providers should be aware that there are schemes perpetrated by Prescribers. The following is a list of types of FWA that could be perpetrated by prescribers. This is included for educational purposes only and is not an all-inclusive list. Illegal remuneration schemes: Prescriber or member is offered, paid, solicited, or receives unlawful remuneration to induce or reward them for inappropriate behavior. An example of an illegal remuneration scheme would be when a Prescriber receives something of value for writing prescriptions for medically inappropriate or unnecessary drugs or products or to induce the Prescriber to prescribe certain medications rather than others. Another example would be when a pharmacy waives a member s copay to encourage their patronage. Prescription drug switching: Drug switching involves the billing for one drug but dispensing a different drug. Script mills: Provider writes prescriptions for drugs that are not medically necessary, often in mass quantities, and often for patients that are not his or hers. Theft of prescriber s drug enforcement administration (DEA) number or prescription pad: Prescription pads and/or DEA numbers can be stolen from Prescribers. In the context of e-prescribing, includes the theft of the provider s authentication (login) information. Inappropriate relationships with health care provider: Potentially inappropriate relationships between pharmaceutical manufacturers and health care providers, such as switching arrangements to induce a health care provider to switch the prescribed drug from a competing product; incentives offered to health care providers to prescribe medically unnecessary drugs; consulting and advisory payments, payments for detailing, business courtesies and other gratuities, educational and research funding; improper entertainment or incentives offered by sales agents. OptumRx pharmacy manual: 7th edition 49

50 Illegal usage of free samples: Providing free samples to health care providers knowing and expecting those health care providers to bill the federal health care programs for the samples. Phantom claims billing: Provider submits claims for services or products not provided. Network Pharmacy Providers should be aware that there are schemes perpetrated by Members. The following is a list of types of FWA that could be perpetrated by members, including beneficiaries enrolled in the Medicare Part D Program: Overutilization and drug-seeking members: The number of persons admitting to abuse of controlled substances has increased in the past decade. The abuse has risen dramatically in prescription drugs. Altered and forged prescriptions: Member alters the quantity and/or strength on a valid prescription or illegally creates prescriptions using stolen or forged prescription pads or by other methods of FWA. Pharmacy hopping and doctor shopping: Persons that visit numerous doctors to obtain prescriptions for prescription drugs and/or controlled substances and visit numerous pharmacies to facilitate the filling of excessive quantities of prescription drugs. Prescription diversion and inappropriate use: Members obtain prescription drugs from a Network Pharmacy Provider and give or sell these medications to someone else. Also can include the inappropriate consumption or distribution of a beneficiary s medications by a caregiver or anyone else. Resale of drugs on black market: Member falsely reports loss or theft of drugs or feigns illness to obtain drugs for resale on the black market. Misrepresentation of status: A Medicare beneficiary misrepresents personal information, such as identity, eligibility or medical condition in order to illegally receive Medicare benefits. The following is a list (not all inclusive) of types of FWA that could be perpetrated by a Network Pharmacy Provider: Billing for Brand Name Drugs and dispensing generic medications. Overbilling of quantity prescribed. Inappropriate billing of compounds. Use of dummy DEA/NPI or Invalid DEA/NPI numbers to obtain a paid response. Billing for Brand Name Drug with DAW 1 when a physician has not specified Do Not Substitute on the prescription, or other inappropriate use of DAW codes. Billing for larger pack sizes when one smaller pack size will meet the directions of the physician and remain within the plan s maximum days supply. Billing for more fills or refills than were authorized. Prescription splitting to obtain multiple dispensing fees, etc. Billing for invalid prescriptions due to lack of a legal Prescriber, forgery, or false or fictitious documents. Dilution of product provided to Member/consumer. Acquisitions of prescription drugs on black market and black market sales. Collusion with Prescribing Physician, wholesaler or others and kickback schemes. Pill shorting to Members/consumer dispensing less than quantity billed. Selling the same medication twice recycling pills. Long-term care pharmacy billing for unused medications and not applying credit to Member. OptumRx pharmacy manual: 7th edition 50

51 Inappropriate, inaccurate or incomplete record-keeping practices related to billed prescriptions. Prospective billing. OptumRx contracted network provider pharmacy fraud, waste and abuse (FWA) and general compliance training attestation OptumRx Contracted Network Provider Pharmacies are required to electronically sign this attestation to satisfy mandatory compliance requirements related to guidance from the Centers for Medicare & Medicaid Services (CMS). CMS has set forth expressed guidance within the Federal Register at Title 42 of the Code of Federal Regulations (CFR), Parts 422 and 423 and other agency guidance requiring Medicare Advantage and Prescription Drug Plan sponsors, or their delegates, first-tier, related, and downstream (FDR) entities to demonstrate compliance with the following: 1. Contracted Network Provider Pharmacy hereby verifies and certifies that it has reviewed and conducted satisfactory annual Fraud, Waste and Abuse (FWA) and general compliance training programs or has utilized the training program provided by CMS and also has provided staff with links to our client sponsor Code of Conduct policies, which is located online at optumrx.com/rxsolhcpweb/fraudabuse/fraudwasteabuse.html. In addition, Contracted Network Provider Pharmacy hereby verifies and certifies that it has not been excluded from participation in federal health care programs by checking its status in Federal programs exclusion lists maintained by the General Services Administration (GSA) and the Department of Health and Human Services Office of Inspector General (HHS-OIG). In turn, Pharmacy has reviewed the Health & Human Services (HHS) Office of Inspector General (OIG) and General Services Administration s (GSA) lists prior to hire/contracting and monthly thereafter for its current employees/contractors, health professionals or vendors that work on MA, Part D or Medicaid programs to ensure that none are excluded from participating in these programs. This information is available at the following sites: Office of Inspector General s (OIG) List of Excluded Individuals/Entities (LEIE) oig.hhs.gov/ General Services Administration (GSA) Excluded Parties List System (EPLS) sam.gov/ General Services Administration (GSA) System for Award Management (SAM) sam.gov/ Note: CMS does not require that first-tier and downstream (FDR) entities adopt client sponsor Code of Conduct policies, but that these sponsors distribute to first-tier and downstream (FDR) contracting entities for the purposes of supporting CMS Fraud, Waste and Abuse and general compliance requirements. 2. Contracted Network Provider Pharmacy hereby verifies and certifies that attendance logs, materials, training documents and other evidence in support of compliance with item 1. above is and shall continue to be made available by Network Contracting Pharmacy for inspection and review by OptumRx or auditor during on-site audits or other review processes. This inspection may also be conducted by the Payer(s) and other federal regulatory agencies as outlined in 42 CFR (e) and (d)(2). The pharmacy will also be required to provide this documentation upon initial credentialing and upon re-credentialing as completed by the OptumRx Pharmacy Network Credentialing team. Note: CMS requires records demonstrating compliance with these requirements be maintained for ten (10) years. This includes all individuals trained be listed along with the date the FWA and general compliance training information is provided/completed, and date of Department of Health and Human Services (HHS)-Office of Inspector General(OIG)/ General Services Administration s (GSA) monitoring review. You can download a form for this purpose and keep on file for future audit purposes. It is not necessary to send this to OptumRx, but it must be made available immediately upon request in the event of an audit. In our experience, auditors expect us to provide this information the same day it is requested, and we greatly appreciate your cooperation. OptumRx pharmacy manual: 7th edition 51

52 You are required to report any suspected or potential fraud, waste and abuse. To report an incident, please contact the OptumRx Pharmacy Network Relations Department at or via to Sponsors, first-tier and downstream entities (including Network Pharmacy Providers) should initiate an inquiry immediately, but no less than two (2) weeks from the date that a potential fraud matter is identified. If, upon investigation, the Network Pharmacy Provider believes that potential misconduct has occurred, the Network Pharmacy Provider should report the alleged activity to the OptumRx Pharmacy Help Desk. In addition, the Network Pharmacy Provider may report this information to any of the following: The Customer Services number identified on the back of a Member s ID card. The Medicare Integrity Contractor (MEDIC) at SAFERX or If you have any questions please contact OptumRx [email protected]. C. Pharmacy audits Policy statement All Claims submitted to OptumRx are subject to Audit. The OptumRx Pharmacy Audit Program helps to ensure that claims are submitted and dispensed in accordance with OptumRx guidelines and that the pharmacy provider complies with those guidelines. The audit program also helps to protect against fraud, waste and abuse. Purpose Audits may take the form of a phone call, on-site visit, or internal claims review (desktop audit) and facility and or compliance reviews. The pharmacy provider will provide OptumRx, or its designee, during normal business hours, access to examine, audit, scan and copy any and all records deemed by OptumRx as necessary to determine compliance with the terms of the Agreement. These audits are necessary for Benefit Plan Sponsors to comply with State and Federal requirements. Any discrepant claims found during an audit will require reimbursement to OptumRx. Audit recoveries will be deducted from future remittances to Pharmacy. Should insufficient funds be available to offset such recoveries, pharmacy will be responsible to submit payment within fifteen (15) days of demand for payment. The purpose of the OptumRx policy is: A. To validate any and/or all of the following: Accuracy of paid Claims, contractual compliance, regulatory compliance, various aspects of medication inventories, presence of required signage and/or documentation, and/or B. To observe any and/or all of the following: Overall facility operations and conditions, and/or C. To monitor for, detect and prevent fraud, waste and abuse activities, or transaction submission errors in the billing of prescription Claims. In-depth audits generally contain a larger number of transactions and include a comprehensive review of prescriptions and their supporting documentation, proofs of delivery, credentialing, licensure review, confirmation work and facility/compliance reviews. OptumRx pharmacy manual: 7th edition 52

53 Procedures for policy compliance OptumRx will notify the Pharmacy Provider no less than two (2) weeks advance written notification of a pending in-depth audit involving claim review. However, if OptumRx suspects that the Pharmacy Provider has engaged in fraudulent activity, OptumRx may conduct an on-site audit without advance notice. Should the Pharmacy Provider refuse to allow OptumRx access to the pharmacy, OptumRx reserves the right to recover the full amount paid or due to the Pharmacy Provider for any claims subject to the audit and may terminate the Pharmacy Provider for cause. On-site audits Auditor staff will call pharmacy to confirm a date and a time. Network Pharmacy Provider will be contacted within seven (7) days prior to on-site audit with written or oral confirmation of date and time. Pharmacy must be adequately staffed to assist in the audit and answer any questions, while limiting disruption in the pharmacy. Pharmacy may not refuse a prescheduled on-site audit at the time of auditor arrival. A denial of this request will be determined to be denial of access. Auditor must be given a safe work space with a sufficient work surface that has adequate lighting and access to an electrical outlet within the confines of the pharmacy. Auditors must be given full access to the books, records, files, lists, signature logs and documentation associated with OptumRx Claims submitted by the Network Pharmacy Provider. A denial of this request will be determined to be denial of access. Auditors must witness the physical extraction of original records from the Network Pharmacy Provider Archives (e.g., Pharmacy records need to be pulled by Pharmacy staff in view of the auditor). A denial of this request will be determined to be a denial of access. Auditor reserves the right to request copies/scanned images of original purchase invoices for medications associated with the submitted Claims. Alternatively, a summary statement of purchases by NDC for the date range requested may be required to be requested of distributors by the pharmacy and be provided directly to OptumRx by the distributor. Upon request, auditor must be provided copies of drug pedigree documentation, and copies of the front and back of all cancelled checks to support purchases. A denial of this request will be determined to be denial of access. Auditor reserves the right for an extension of the original desk audit or on-site audit. A denial of this request will be determined to be denial of access. A denial of access is determined to be a breach of the audit provisions of the Agreement. The Network Pharmacy Provider may be subject to immediate suspension or termination for noncompliance. Auditor may inspect books, records, files, lists, signature logs and documentation pertaining to the provision of Covered Prescription Services during the term of the Agreement and for a period of two (2) years, or as determined under state law, subsequent to the termination of the Agreement. Network Pharmacy Provider must retain an original document of record in its archives as required under State and Federal law and for a period of no less than five (5) years from the date of the applicable transaction, and ten (10) years in the case of Medicare Part D records. OptumRx pharmacy manual: 7th edition 53

54 Original document of record is defined as an original prescription order from a licensed prescriber, or duly authorized health care professional, executed as required under State and Federal laws, a fully compliant fax order, or fully compliant phone-in order slip reduced to writing and noting the date and time of the phone order and the name of the individual authorizing the medication, or a fully compliant e-prescription. Pharmacy must provide a copy of any compound worksheets identifying ingredients used in a compounded medication. Each document as listed above is to be filed as an original document in the archives of the Network Pharmacy Provider, to be retrieved for inspection at the request for audit by auditor. An original or digital image of the signature log will be accepted as audit evidence for receipt of goods. The Network Pharmacy Provider will receive written disclosure of initial/preliminary audit findings subsequent to the field work. The Network Pharmacy Provider (or their pharmacies) will be given the opportunity to dispute any audit findings by filing an appeal within thirty (30) days, or as indicated by state law, from the receipt date of the initial/preliminary audit results letter. Such documentation must be sent via certified mail or other method that evidences tracking such as FedEx, etc., to the attention of the OptumRx Network Audit Manager, or as otherwise instructed in the initial/ preliminary audit results letter. Upon extenuating circumstances, a request for an extension may be granted at the sole discretion of OptumRx. Receipt of such an extension request must be received in writing within the required thirty (30) days appeal time frame or as otherwise instructed in the initial/preliminary audit results letter. Failure to submit appeals by the time frame allowed will subject any applicable discrepancy to recoupment as indicated in the initial/preliminary audit results letter. Post-audit documentation must consist of original hard copies of prescriptions (no verbal orders). Final audit findings will be provided after the dispute period has lapsed, in accordance with any applicable state law, and with consideration of any dispute that was filed timely. Audit findings will indicate where a full or partial recoupment is necessary, or indicate that a finding is educational only. The Network Pharmacy Provider will receive a chargeback against future remittances until paid-in-full for any discrepancies found during the audit. Payments to OptumRx are only necessary if the Network Pharmacy Provider is no longer operating, if there is no current Pharmacy Network Agreement in effect, or if insufficient payment activity is available to offset the chargebacks. OptumRx at its sole discretion may elect to notify a Pharmacy Services Administrative Organization (PSAO) of any significant audit findings, if the pharmacy in question is affiliated with a PSAO. Facility reviews may include review and documentation of all applicable licensures, proof of identification of employees, compliance with all state and federal regulatory requirements, proof of compliance with return to stock policy, various other reviews and inquiries to assure that overall quality assurance measures are implemented. Facility reviews may require proof of compliance in providing the Medicare Prescription Drug Coverage and Your Rights notice to all Medicare Members when a prescription cannot be covered ( filled ) under Medicare Part D ( Part D ) benefit at the point of sale and the coverage determination results in a 569 reject response. Desktop and telephone audits Network Pharmacy Provider is required to answer reasonable telephone inquiries by the Audit Department, as determined solely by OptumRx, to validate a Member being billed, prescription directions, compounding ingredients, quantities being dispensed, etc. All in-depth audits will be directed by written correspondence. All in-depth desktop audits will be directed by written correspondence. OptumRx pharmacy manual: 7th edition 54

55 Where billing agents are utilized by a Network Pharmacy Provider, OptumRx may coordinate audits with the billing agent, but Network Pharmacy Provider remains responsible for all billing outcomes, verification and validation. Network audits may be performed by OptumRx staff, or by an agent authorized solely by OptumRx. Miscellaneous audit information In situations where cumulative errors rise to the level of negligence, fraud or abuse, as determined solely by OptumRx, OptumRx reserves the right to extrapolate audit sample exceptions against the entire population under audit. The following is a partial list of audit violations that could be perpetrated by a Network Pharmacy Provider resulting in Claims being recovered in total and no reimbursement will be forthcoming for what was actually dispensed. In addition, legal or other action may be taken against the Network Pharmacy Provider, including immediate termination from the Network: Billing for Brand Name Drugs and dispensing Generic Drugs. Overbilling of quantity prescribed. Inappropriate billing of compounds. Undocumented substitution. Noncovered item billed as covered. Duplicate claim billed. Submitting Claims for medications not rendered and/or prescribed. Use of dummy DEA/NPI or Invalid DEA/NPI numbers to obtain a paid response. Billing for Brand with DAW 1 when a physician has not specified Do Not Substitute on the prescription, or other inappropriate use of DAW codes. Billing for more fills or refills than were authorized or illegal refill of a schedule II narcotic prescription. Prescriptions filled after their legal time limit. Billing for invalid prescriptions due to lack of a legal prescriber, forgery, or false or fictitious documents. Prescriptions misfilled based on original order. Refills too soon that were paid due to a prior days supply violation. Inability to locate the original prescription (missing). Prescriptions lacking sufficient proof of delivery to Member. Prescriptions where a Member denies receiving medication billed. Prescriptions where physician denies prescribing medication billed. Prescriptions returned to stock but not reversed. Prescriptions missing date written, or filled before date authorized. Prescriptions missing physician signature. Prescription missing any other required information by state or federal government or is otherwise not a legal prescription. Long-term care pharmacy billing for unused medications and not applying credit to Member. Medication to be billed under Medicare Part A or Part B versus under Part D. OptumRx pharmacy manual: 7th edition 55

56 Inappropriate, inaccurate or incomplete record-keeping practices related to billed prescriptions. The following is a partial list of audit violations that could be perpetrated by a Network Pharmacy Provider where Claims will be recovered for a partial reclaim of the prescription or recovered in total if pattern of abuse is evident. In addition, legal or other action may be taken against the Network Pharmacy Provider, including termination from the Network: Overbilling of quantity in relation to days supply that exceeds plan maximums, or not in conformance with that prescribed. Billing for larger pack sizes when one smaller pack size will meet the directions of the physician and remain within the Benefit Plan s maximum days supply. Prescription splitting to obtain multiple dispensing fees, etc. Billing multiple lower strengths when one higher strength medication prescribed. Again, the above is only a partial listing of sample audit violations. A more complete list with expanded descriptions can be found in Exhibit F. OptumRx reserves the right to assess a penalty equal to the entire amount of the Claim (including copayment) for each violation, in addition to the prescription value or difference in billing being recovered. Material repetition or pattern of practice of any given category of audit violation or the material combination of different categories of violations discovered during an audit may subject Network Pharmacy Provider to further disciplinary action potentially including termination from OptumRx Network(s). Instances of alleged FWA discovered during audit shall subject Network Pharmacy Provider to immediate termination. Any network pharmacy provider terminated from OptumRx network(s) for reason(s) other than suspected fraud and abuse must wait a minimum of three (3) years from date of effective termination before applying for reconsideration regarding Network participation. Pharmacy terminations for suspected fraud and abuse are considered permanent. Withheld amounts due to audit findings that are not documented within three (3) months are subject to refunding to clients without further appeal. OptumRx reserves the right to temporarily suspend future payments in cases of suspected FWA pending the outcome of an investigation, or as applicable under state or federal regulations. PRESCRIPTION ORIGIN CODE Claim SUBMISSION: OptumRx ( ORx ) routinely performs audits of pharmacies within the provider network. Discrepancies found during an audit may be subject to recoupments depending on the nature of the findings. This information is intended to educate OptumRx network pharmacies on how to correctly submit Prescription Origin Code in conformance with the National Council for the Prescription Drug Programs (NCPDP) and ORx requirements. Please submit one of the following data elements within Prescription Origin Code (419-DJ): 1 = Written 2 = Telephone 3 = Electronic 4 = Facsimile (Fax) 5 = Pharmacy (Covers situation where a new Rx number needs to be created from an existing valid prescription, such as a traditional transfer) OptumRx pharmacy manual: 7th edition 56

57 Claims submitted for a prescription missing one (1) of these values will reject with the following NCPDP Rejection Code 33 RX ORIGIN CODE CANNOT BE 0 ON NEW CLM. If rejection occurs, please resubmit the Claim with the appropriate value. To reduce processing errors, please confirm the information on member s ID card prior to submitting prescription claims. D. Credentialing In order to become a Network Pharmacy Provider, you must submit a credentialing application, meet the OptumRx credentialing requirements, and be able to comply with the requirements of the Agreement and OptumRx Pharmacy Manual. All Network Pharmacy Providers and Pharmacists shall be credentialed pursuant to the OptumRx credentialing policy prior to submitting any Claims. If you are a PSAO or a pharmacy affiliated with a PSAO: A PSAO must certify that Pharmacies that are affiliated with the PSAO meet the OptumRx requirements and the PSAO must certify the presence of an ongoing policy to ensure the Pharmacies meet these requirements and abide by the Agreement and Pharmacy Manual. If you are a pharmacy that is not affiliated via PSAO: Pharmacies are required to apply for access to the OptumRx Pharmacy Network and are required to meet all of the requirements in the Agreement and Pharmacy Manual, including any supplements and/or additions. You can request a credentialing application from OptumRx via the following: Pharmacy Network Contracting Department Von Karman MS: CA Irvine, CA Telephone: Fax: address: [email protected] Pharmacy Providers requesting mail service and/or specialty network access must be certified with both Verified Internet Pharmacy Practice Sites ( VIPPS ) and URAC (formerly Utilization Accreditation Commission). Additional information regarding these organizations and criteria for certification may be found at the following websites: VIPPS: vipps.nabp.net URAC: urac.org In addition to credentialing, Federal regulations apply to providers, individuals or entities that have been excluded from Federal program participation as evidenced by listing in the Health and Human Services Department (HHS) OIG or General Services Administration (GSA) Excluded and Sanctioned Providers listings. a. Pharmacies must check these lists upon hire and at least monthly to ensure employees working with Medicare business have not been excluded from Federal program participation. Pharmacy staff can check these lists by using the following links: OIG: oig.hhs.gov/fraud/exclusions.asp GSA: epls.gov/epls/search.do OptumRx pharmacy manual: 7th edition 57

58 E. Confidentiality and proprietary rights Network pharmacy providers agree to keep confidential and proprietary the following: Terms of the Agreement and documentation related to the performance of the Agreement, including, and without limitation, the drug Formulary and Maximum Allowable Cost (MAC) list; Methods of doing business, including the operations of the National Pharmacy & Therapeutics Committee and OptumRx utilization review and quality assurance procedures and programs; and Any and all symbols, logos, trademarks, trade names, service marks, patents, inventions, copyrights, copyrightable material, trade secrets, personnel information, operating manuals, memoranda, work marketing programs, plans and strategies, operating agreements, financial information and strategies, and computer software and other computer-related materials developed or used in OptumRx business. F. Involuntary disenrollment by benefit plan or sponsor Network Pharmacy Provider shall cooperate with OptumRx and its Clients in gathering and/or providing information on Members for which the Benefit Plan or Sponsor is seeking involuntary disenrollment for conduct considered abusive and disruptive to the point where service is disrupted for the Member or other Members. If Network Pharmacy Providers encounter abusive and disruptive Members, they should contact OptumRx Customer Service using the contact information provided in Section II of this Pharmacy Manual. As a Network Pharmacy Provider, OptumRx encourages that you keep notes and any documentation concerning abusive and disruptive contact as you may be asked to provide this information at the time you report abusive and disruptive Members. G. State medicaid requirements Particular states have certain Medicaid regulatory requirements, including specific provisions to be included in all Client subcontractor agreements ( State Medicaid Regulatory Requirements ). Such State Medicaid Regulatory Requirements are contained in the state specific appendix, which is attached as Exhibit E ( State Appendix ). Pursuant to the terms of the Agreement, Network Pharmacy Provider shall comply with all applicable requirements in each applicable State Appendix, as determined solely by OptumRx. H. Definitions The following terms are used throughout this document and are derived from Network Provider Agreements, CMS regulations and other program documents: Abuse: Includes actions that may, directly or indirectly, result in unnecessary costs to the Medicare Program. Abuse involves payment for items or services when there is not legal entitlement to that payment and the provider has not knowingly and or/intentionally misrepresented facts to obtain payment. OptumRx pharmacy manual: 7th edition 58

59 Average wholesale price (AWP): Shall mean the average wholesale price of medication drugs or ancillary supplies, as applicable, as dispensed and as set forth in the latest edition of the Medi-Span Prescription Pricing Guide (with supplements) or any other nationally recognized pricing source selected by Administrator (the Pricing Source ), as updated at least monthly. For prescription drug products dispensed somewhere other than a mail service pharmacy, AWP is based on the individual units dispensed or smallest package size available (e.g., per vial, per suppository, etc.). For prescription drugs dispensed by Administrator s mail service pharmacy, AWP is based on a package size of one hundred (100) units for pills, capsules and tablets and 480 ml quantities for liquids (or the next closest package size if such quantities or sizes are not available). Benefit plan: The benefit provided to Members, including under any Medicaid, MAPD Plan or PDP Plan. Benefit Plan coverage shall include, without limitation, any deductible or coverage gap provided for under such coverage, without regard to any subsidy by any third-party of a Member s cost-sharing obligations under the applicable Benefit Plan. Benefit plan sponsor or plan sponsor: The entity that is sponsoring a Benefit Plan. Brand name drug: A drug marketed under a proprietary and trademark-protected name. Claim: A Pharmacy s billing or invoice for a single Prescription for Covered Prescription Services dispensed to a Member. Clean claim: A Claim, prepared in accordance with the standard format promulgated by the National Council for Prescription Drug Programs (NCPDP), electronic, batch, and on paper, which contains all of the information necessary for processing (including, without limitation, the Member ID number, the Member s name and date of birth, Prescription Drug Product NDC number, drug quantity, days supply, health care provider DEA/NPI) number, NCPDP/NPI number date of service, Submitted Cost Amount and the Usual and Customary Charge (U&C)). Claims submitted in non-ncpdp standard format will not be considered a Clean Claim and will be subject to an additional claim processing charge. Client: Any person or entity which has entered into, or in the future enters into, a written agreement with Administrator pursuant to which Administrator provides certain consultative, administrative and/or claims processing services in connection with the operation of one or more Benefit Plans sponsored, issued or administered by such person or entity and/or that person s or entity s customer. Cost sharing or cost-sharing amounts: The coinsurance, copayments or other amounts which Pharmacy is entitled to collect from a Member for Covered Prescription Services in accordance with the terms and conditions of the Member s Benefit Plan. Covered prescription services: The prescriptions and other pharmaceutical products, services and supplies dispensed by a Pharmacy to a Member for which coverage is provided pursuant to the terms and conditions of the Benefit Plan. OptumRx pharmacy manual: 7th edition 59

60 Drug product: The Brand Name Drug or Generic Drug which is (i) required under applicable laws and regulations to be dispensed only pursuant to a Prescription and (ii) is approved by the FDA. Financial institution: The financial institution used by Network Pharmacy Providers. Formulary: The entire list of Drug Products, devices, products and/or supplies covered by the applicable Benefit Plan. Fraud: Knowingly and willfully executing, or attempting to execute, a scheme or artifice to defraud any health care benefit program; or to obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any health care benefit program. (18 United States Code 1347). Generic drug: Shall mean and refer to a drug product, whether identified by its chemical, proprietary or nonproprietary name, which is accepted by the FDA as therapeutically equivalent to an originator Drug Product. Maximum allowable cost ( MAC ): Shall mean the lists developed by Administrator specifying the maximum unit ingredient cost payable to Company/ Pharmacy for dispensing any Drug Product included on such lists. Medicare drug prescription plan member: See Member. Medicare prescription drug plan (MA-PD): The CMS-approved MA-PD plans sponsored, issued or administered by Clients as defined in 42 C.F.R , and includes, but is not limited to, private fee-for-service plans as defined in the Medicare Advantage rules and any CMS demonstration programs that provide prescription drug benefits. For purposes of this Agreement, MAPD Plan also includes any employer-sponsored MA-PD plan referenced in 42 C.F.R Member: An individual who is eligible and enrolled to receive coverage through a Benefit Plan from a Client for Covered Prescription Services. Network pharmacy provider: The entity that is contracted with ORx or indirectly contracted through a Pharmacy Services Administration Organization (PSAO) to provide covered prescriptions to ORx Clients. Pharmacy/network pharmacy provider: The entity that is contracted directly with OptumRx or indirectly contracted through a Pharmacy Services Administration Organization ( PSAO ) to provide covered prescriptions to OptumRx Clients, in accordance with the Agreement, addenda, exhibits, subsequent amendments, etc., and as specified in the Agreement. Pharmacist: An individual appropriately licensed in their respective States to dispense medications to Members of those States. OptumRx pharmacy manual: 7th edition 60

61 Pharmacy services administration organization ( PSAO ): See Pharmacy. Point of sale ( POS ) system: The online or real-time (point-of-sale) telecommunication system used to communication information including, but not limited to, Covered prescription Services. Prescriber: An individual appropriately licensed in their respective States to write prescriptions for Members. Prescribing physician: An individual appropriately licensed in their respective States as a physician. Prescription drug plan ( PDP Plan ): The CMS-approved Medicare Part D prescription drug coverage offered under a policy, contract or plan that is sponsored, issued or administered by Clients pursuant to a contract with CMS, as defined in 42 C.F.R , and includes, but is not limited to, any CMS demonstration programs that provide prescription drug benefits. For purposes of the Agreement, PDP Plan also includes any employer-sponsored group prescription drug plans, as defined in 42 C.F.R Specialty drugs: Includes biotechnology products, orphan drugs used to treat rare diseases, typically high-cost drugs, oral or injectable medications, including infusions in any outpatient setting, drug requiring ongoing frequent management/monitoring of the patient by clinician or drugs used to treat chronic and potentially life-threatening diseases. Sponsor: The sponsor of a Benefit Plan. Usual and customary charge ( U&C ): The price, including all applicable customer discounts, such as special customer, senior citizen and frequent shopper discounts, that a cash paying customer pays Pharmacy for Drug Products, devices, products and/or supplies. Waste: Overutilization of services, or other practices that, directly or indirectly, result in unnecessary costs to the Medicare Program. Waste is generally not considered to be caused by criminally negligent actions but rather the misuse of resources. Wholesale acquisition cost ( WAC ): Shall mean the average wholesaler acquisition cost of a Covered Prescription Service based on the Medi-Span Prescription Pricing Guide (with supplements) or any other nationally recognized pricing source selected by Administrator (the Pricing Source ), as updated at least monthly. OptumRx pharmacy manual: 7th edition 61

62 Exhibit A Pharmacy electronic remittance advice (ERA) The ERA enrollment form is also available at the following: optumrx.com/rxsolhcpweb/cmscontent.do?pageurl=/hcp/healthcareprovidertools/pharmacyera OptumRx pharmacy manual: 7th edition 62

63 Exhibit B Pharmacy electronic funds transfer (EFT) This EFT form is also available at the following: optumrx.com/rxsolhcpweb/cmscontent.do?pageurl=/hcp/healthcareprovidertools/pharmacyeft OptumRx pharmacy manual: 7th edition 63

64 Exhibit C Network pharmacy provider credentials Please note: only complete documents will be accepted. For independent pharmacies (not affiliated via PSAOs/GPOs) OptumRx pharmacy manual: 7th edition 64

65 For chain pharmacies/psaos/gpos OptumRx pharmacy manual: 7th edition 65

66 Exhibit D Pharmacy provider Manual for UnitedHealthcare community plan STAR, STAR+PLUS and CHIP products. Click here for a link to the TX pharmacy provider Manual in this document. Exhibit E State medicaid regulatory requirements The following State Appendices set forth certain State Medicaid Regulatory Requirements that Network Pharmacy Providers shall comply with in their respective states, as applicable. State with linked documents denoted in bold. 1. Alabama (AL) Medicaid regulatory requirements. 2. Alaska (AK) Medicaid regulatory requirements. 3. Arizona (AZ) Medicaid regulatory requirements: a. Medical subcontractor b. Children s rehabilitative services Medical subcontractor c. Medicaid division of developmentally disabled program Medical subcontractor d. LTC Medical subcontractor 4. Arkansas (AR) Medicaid regulatory requirements. 5. California (CA) Medicaid regulatory requirements. 6. Colorado (CO) Medicaid regulatory requirements. 7. Connecticut (CT) Medicaid regulatory requirements. 8. Delaware (DE) Medicaid regulatory requirements. 9. District of Columbia (DC) Medicaid regulatory requirements: a. Regulatory requirements provider b. Medical subcontractor c. Regulatory requirements unison and/or UHN provider 10. Florida (FL) Medicaid regulatory requirements. a. FL Medicaid non-medical subcontractor b. FL FHK Nnon-Medical subcontractor c. FL DOEA non-medical subcontractor d. FL Medicaid subcontractor e. FL Medicaid provider f. FL Requirements HSA g. TPA requirements 11. Georgia (GA) Medicaid regulatory requirements. OptumRx pharmacy manual: 7th edition 66

67 12. Hawaii (HI) Medicaid regulatory requirements. a. Medical subcontractor b. Regulatory requirements downstream provider 13. Idaho (ID) Medicaid regulatory requirements. 14. Illinois (IL) Medicaid regulatory requirements. 15. Indiana (IN) Medicaid regulatory requirements. 16. Iowa (IA) Medicaid regulatory requirements (hawk-i): a. Medical subcontractor 17. Kansas (KS) Medicaid regulatory requirements: a. Medical subcontractor b. KanCare community Plan 18. Kentucky (KY) Medicaid regulatory requirements. 19. Louisiana (LA) Medicaid regulatory requirements. 20. Maine (ME) Medicaid regulatory requirements. 21. Maryland (MD) Medicaid regulatory requirements: a. Medical subcontractor 22. Massachusetts (MA) Medicaid regulatory requirements: a. MassHealth senior Care b. Regulatory requirements downstream provider c. Regulatory requirements provider 23. Michigan (MI) Medicaid regulatory requirements: a. Subcontractor 24. Minnesota (MN) Medicaid regulatory requirements. 25. Mississippi (MS) Medicaid regulatory requirements: a. Regulatory requirements downstream provider b. Regulatory requirements CHIP subcontractor 26. Missouri (MO) Medicaid regulatory requirements. 27. Montana (MT) Medicaid regulatory requirements. 28. Nebraska (NE) Medicaid regulatory requirements: a. Medical subcontractor b. Regulatory requirements provider 29. Nevada (NV) Medicaid regulatory requirements. 30. New Hampshire (NH) Medicaid regulatory requirements. 31. New Jersey (NJ) Medicaid regulatory requirements: a. Medical subcontractor OptumRx pharmacy manual: 7th edition 67

68 32. New Mexico (NM) Medicaid regulatory requirements: a. Medical subcontractor 33. New York (NY) Medicaid regulatory requirements: a. NY requirements a. NYDOH For purposes of doing business in New York, the Prescription Drug Services Agreement, as amended, ( Agreement ) is contracted through OptumRx NY IPA, Inc. b. NY requirements b. NYSDOH c. FHP, CHP- IPA Medical subcontractor d. FHP, CHP- MSA Medical subcontractor 34. North Carolina (NC) Medicaid regulatory requirements. 35. North Dakota (ND) Medicaid regulatory requirements. 36. Ohio (OH) Medicaid regulatory requirements: a. OH requirements 37. Oklahoma (OK) Medicaid regulatory requirements. 38. Oregon (OR) Medicaid regulatory requirements. 39. Pennsylvania (PA) Medicaid regulatory requirements: a. Medical subcontractor b. Government-sponsored programs addendums c. PA requirements 40. Rhode Island (RI) Medicaid regulatory requirements: a. Medical subcontractor 41. South Carolina (SC) Medicaid regulatory requirements: a. Medicaid MCO program and healthy connections kids program b. Medical subcontractor 42. South Dakota (SD) Medicaid regulatory requirements. 43. Tennessee (TN) Medicaid regulatory requirements. 44. Texas (TX) Medicaid regulatory requirements. a. Medical subcontractor 45. Utah (UT) Medicaid regulatory requirements. 46. Vermont (VT) Medicaid regulatory requirements. 47. Virginia (VA) Medicaid regulatory requirements. 48. Washington (WA) Medicaid regulatory requirements: a. Medical subcontractor 49. West Virginia (WV) Medicaid regulatory requirements. 50. Wisconsin (WI) Medicaid regulatory requirements. 51. Wyoming (WY) Medicaid regulatory requirements. OptumRx pharmacy manual: 7th edition 68

69 Exhibit F NCPDP SUBMISSION CLARIFICATION CODE 420-DK Submission clarification code Definition of field Code indicating that the pharmacist is clarifying the submission Field format 9(2) T, P, A Standard/version formats Field limitations Values: Code Description 1 Not specified, default 2 No override 3 Other override 4 Lost prescription The pharmacist is indicating that the cardholder has requested replacement of medication that has become lost. 5 Therapy change The pharmacist is indicating that the physician has determined that a change in therapy was required; either that the medication was used faster than expected, or a different dosage form is needed, etc. 6 Starter dose The pharmacist is indicating that the previous medication was a starter dose and now additional medication is needed to continue treatment. 7 Medically necessary The pharmacist is indicating that this medication has been determined by the physician to be medically necessary. 8 Process compound for approved ingredients 9 Encounters 10 Meets plan limitations The pharmacy certifies that the transaction is in compliance with the program s policies and rules that are specific to the particular product being billed. 11 Certification on file The supplier s guarantee that a copy of the paper certification, signed and dated by the physician, is on file at the supplier s office. 12 DME replacement indicator Indicator that this certification for a DME item replacing a previously purchased DME item. 13 Payer-recognized emergency/disaster assistance request The pharmacist is indicating that an override is needed based on an emergency/disaster situation recognized by the payer. 14 Long-term care leave of absence The pharmacist is indicating that the cardholder requires a short-fill of a prescription due to a leave of absence from the Long-Term Care (LTC) facility. continued next page OptumRx pharmacy manual: 7th edition 69

70 Code Description 15 Long-term care replacement medication Medication has been contaminated during administration in a Long-Term Care setting. 16 Long-term care emergency box (kit) or automated dispensing machine Indicates that the transaction is a replacement supply for doses previously dispensed to the patient after hours. 17 Long-term care emergency supply remainder Indicates that the transaction for the remainder of the drug originally begun from an Emergency Kit. 18 Long-term care patient admit/readmit indicator Indicates that the transaction is for a new dispensing of medication due to the patient s admission or readmission status. 00 Other Carrier UHCACIS01 UHCPRIM01 UHCUHCI01 Platform ACIS PRIME ACIS Alt ID Non-standard Standard Standard Standard Submitted UH+7 digit policy# UHealth1 UHC UHealth1 group BIN PCN DMR mailing address P.O. Box Hot Springs, AR P.O. Box Hot Springs, AR P.O. Box Hot Springs, AR P.O. Box Hot Springs, AR Exhibit G Audit violations Click here for a link to the audit discrepancy descriptions. OptumRx pharmacy manual: 7th edition 70

71 2300 Main Street, Irvine, CA OptumRx specializes in the delivery, clinical management and affordability of prescription medications and consumer health products. We are an Optum TM company a leading provider of integrated health services. Learn more at optum.com. All Optum TM trademarks and logos are owned by Optum, Inc. All other brand or product names are trademarks or registered marks of their respective owners. ORX5979A_ OptumRx, Inc optumrx.com