United Healthcare Medicare Solutions

United Healthcare Medicare Solutions Part B Specialty Drug Prior Authorization Program Provider Training

Agenda Program Mission Program Description Implementation Timeline Program Resources Prior Authorization Overview Registration of In-Process Treatment Initiating a Prior Authorization Request Urgent Requests Modifying a Prior Authorization Request Verifying Status of an Existing Prior Authorization Claims - Key Points 2

Program Mission There has been a rapid expansion in the availability and cost of specialty drugs. It is also widely appreciated that utilization of these drugs is steadily increasing in the Medicare population [1] and that significant variations can occur in the use of these drugs, as evidenced by studies comparing treatments for conditions such as rheumatologic diseases [2] and certain cancers. [3], [4] Many of these drug combinations, although costly, do not lead either to improved quality of life or increased longevity for the patients who take them. [1] Leonard CE, Freeman CP, MaCurdy T, et al. Utilization and cost of anticancer biologic products among Medicare beneficiaries, 2006-2009. Anticancer Biologics. Data Points #6 (prepared by the University of Pennsylvania DEcIDE Center under contract no. HHSA29020050041I). Rockville, MD: Agency for Healthcare Research and Quality. 2011. AHRQ Publication No. AHRQ 11-EHC002-EF. [2] Jinoos Yazdany; Catherine H. MacLean, Quality of Care in the Rheumatic Diseases - Current Status and Future Directions Posted: 06/05/2008; Curr Opin Rheumatol. 2008;20(2):159-166. 2008 Lippincott Williams & Wilkins [3] Jacob S, Ng W, Asghari R, Delaney GP, Barton MB. Chemotherapy in rectal cancer: variation in utilization and development of an evidence-based benchmark rate of optimal chemotherapy utilization. Clin Colorectal Cancer. 2011 Jun;10(2):102-7. Epub 2011 Apr 22. [4] Genomic testing and therapies for breast cancer in clinical practice. Haas JS, Phillips KA, Liang SY, Hassett MJ, Keohane C, Elkin EB, Armstrong J, Toscano M. J Oncol Pract. 2011 May;7(3 Suppl):e1s-7s. Program Goals: Help improve the quality of care for the member and ensure proper utilization for these drugs. 3

Program Description The UnitedHealthcare Medicare Advantage Part B Specialty Drug Prior Authorization Program is a Prior Authorization process required for UnitedHealthcare Medicare Advantage-network Providers, health care professionals, facilities and ancillary Providers for certain specialty drugs, prior to administration, with administrative claim denial for non-compliance and clinical claim denial for lack of medical necessity. Services that take place in an emergency room (ER), urgent care center or during an inpatient stay do not require Prior Authorization. Please note that for UnitedHealthcare Medicare Advantage, only select specialty drugs will require Prior Authorization. Failure to complete the Specialty Drug Prior Authorization protocol may result in an administrative denial for non compliance. Failure to meet clinical criteria will result in the Prior Authorization request being denied for lack of medical necessity. Services that are not medically necessary are not covered under UnitedHealthcare Medicare Advantage plans. Upon determination of the denial for lack of medical necessity, the member and Provider will receive a denial notice with the appeal process outlined. Claims denied for failure to request Prior Authorization may not be balance-billed to the patient. 4 For a complete list of specialty drugs that require Prior Authorization, please visit: UnitedHealthcareOnline.com > Clinician Resources > Specialty Drugs

Program Resources Program resources will be updated and maintained for reference at UnitedHealthcareOnline > Clinician Resources > Specialty Drugs Medicare Advantage Specialty Drug Prior Authorization Program This Program coordinates with Providers and members while promoting the application of current scientific clinical evidence for certain Specialty Drugs. Summary of Program: States Effective for Dates of Service on or after: Alabama Jan 2, 2012 Arizona, Florida, Georgia, Illinois, Indiana, Iowa, Missouri, North Carolina, Ohio, Rhode Island, Texas, and Wisconsin Apr 2, 2012 California, Connecticut, Nebraska, New Jersey, New York, Tennessee, and Utah Oct 1, 2012 Prior Authorization is NOT required for services that take place in an emergency room, urgent care facility or during an inpatient stay. For in-scope services rendered in an office or out-patient setting, a Provider or other health care professional may request a Prior Authorization on an urgent or expedited basis in cases where there is a medical need to provide the service sooner than the conventional Prior Authorization process would accommodate. Specialty Drug Evidence Based Guidelines: Specialty Drug Evidence Based Guidelines Reference Materials: 2012 Specialty Drug Prior Authorization Table and CPT Code Crosswalk Medicare Advantage Specialty Drug Authorization QRG Medicare Advantage Specialty Drug Authorization FAQ Medicare Advantage Specialty Drug Authorization Plan Inclusion and Exclusion Grid Medicare Advantage Specialty Drug Prior Authorization Training

Program Resources: In-Scope & Out-of Scope Plans INCLUDED PLANS (All transacted on the UnitedHealthcareOnline.com secure website and subject to the UnitedHealthcare Provider Administrative Guide) Medicare Advantage HMO, HMO-POS, PPO and RPPO plans including AARP MedicareComplete, UnitedHealthcare MedicareComplete UnitedHealthcare Medicare Advantage plans for both individual and employer groups members, and group plans sold under UnitedHealthcare Group Medicare Advantage (PPO). This includes all Medicare Advantage network products insured through UnitedHealthcare, including UnitedHealthcare Plan of the River Valley Inc. 6 UnitedHealthcare Dual Complete (HMO SNP), (HMO-POS SNP), (PPO SNP), (Regional PPO SNP) UnitedHealthcare Chronic Complete (HMO SNP) EXCLUDED PLANS Florida: AARP Medicare Complete Plan 1, HMO and AARP Medicare Complete Plus, HMO-POS Gatekeeper benefit plans Group 26000, Group 26016, Group 26018, Group 26019, Group 26020, Group 26021, and UnitedHealthcare Group Medicare Advantage (HMO) Group 54011 and 54012. Refer to the "UnitedHealthcare Medicare Advantage Gatekeeper Plans Referral/Authorization Protocol for Physicians, Facilities, Ancillaries and Other Health Care Professionals, HMO and HMO-POS Medicare Advantage Gatekeeper Plans in Broward, Miami-Dade and Palm Beach Counties Only" posted at UnitedHealthcareOnline.com > Tools and Resources > Welcome Kit for New Physicians and Providers > Medicare > Florida Medicare. New York: AARP Medicare Complete Plan 1 - Group 66074, AARP Medicare Complete Plan 2 - Group 13012, AARP Medicare Complete Essential - Group 66075, AARP Medicare Complete Mosaic - Group 66076. Existing process of obtaining Authorization from Montefiore Care Management Organization (CMO) will continue. UnitedHealthcare Community and State Medicare Advantage Plans Erickson Advantage Plans UnitedHealthcare Nursing Home Plan (HMO SNP), (HMO-POS SNP), (PPO SNP) UnitedHealthcare Senior Care Options (HMO SNP) UnitedHealthcare MedicareDirect (PFFS) The following benefit plans: UnitedHealthcare West Sierra Spectrum (Sierra Health & Life) Senior Dimensions Medicare Advantage Plans (Health Plan of Nevada) Medicaid and other state government plans Commercial benefit plans UnitedHealthcare Community Plan Medicaid, CHIP & Uninsured

Program Resources: Specialty Drugs Requiring Prior Authorization Generic Name Brand Name Azacitidine Vidaza Bevacizumab* Avastin * Bortezomib Velcade Cetuximab Erbitux Denosumab** Xgeva ** Doxorubicin HCl Lipid Doxil, Caelyz Gemcitabine HCl Gemzar Immune Globulin, Intravenous (Lyphilized) Carimune NF, Panglobulin NF and Gammagard SD 7 Immune Globulin, Intravenous (NonLyophilized) Flebogamma, Gammagard, Gammaplex, Gamunex, Octagam, Privigen Ipilimumab Yervoy Paclitaxel Protein-bound Abraxane Panitumumab Vectibix Pemetrexed Alimta Rituximab Rituxan Sipuleucel -T Provenge *** Trastuzumab Herceptin Topotecan Hycamtin *Prior Authorization is only required when Avastin is prescribed as cancer chemotherapy. ** Prior Authorization is only required for Xgeva. Prior Authorization is not required for the brand name drug Prolia. Please include the National Drug Code (NDC) in addition to the HCPC to distinguish these drugs on the claim. *** Prior Authorization is only required for Provenge. Please include the National Drug Code (NDC) in addition to the HCPC to distinguish these drugs on the claim.

Prior Authorization Overview The Medicare Advantage Part B Specialty Drug Prior Authorization Program is a Prior Authorization process required for UnitedHealthcare network Providers, health care professionals, facilities and ancillary Providers for utilization of certain drugs. A Prior Authorization Number must be obtained, in accordance with the Specialty Drug Prior Authorization process, prior to administering. Prior Authorization is NOT required for services that take place in an emergency room, urgent care center or during an inpatient stay A Prior Authorization Number is Specialty Drug-(JCode) specific The day the Prior Authorization is approved will be the starting point for the period in which the course of treatment must be completed. If the course of treatment is not completed within the approved time period, a new Prior Authorization Number must be obtained The length of time for which a Prior Authorization will be valid will vary upon request: - For drugs in the palliative setting the Authorization will be valid for 90 days from when the request was approved - For drugs in the curative and adjuvant setting the Authorization is valid for the number of days required to complete the requested course of treatment. This is calculated by multiplying the number of cycles requested by the length of each cycle and adding 14 calendar days 8

Prior Authorization Overview - Continued Retrospective Authorization requests must be made within two business days of rendering the service. UnitedHealthcare nurses of various specialties, including Oncology and Home Infusion, will be reviewing Prior Authorization requests. UnitedHealthcare Medical Oncologists are available as needed for peer to peer reviews. If a Prior Authorization is not approved the Provider and member will be informed in writing of the reason for the denial, including the clinical rationale, as well as how to initiate an appeal. Any subsequent inquiries for denials need to be routed through the Medicare Solutions Appeals process. CMS requires UnitedHealthcare to track and report all reconsiderations and appeals for compliance. No determinations will be made outside of the appeals process. Failure to complete the Specialty Drug Prior Authorization process will result in an administrative denial. If the Specialty Drug Prior Authorization process is completed, but the requested procedure is not authorized due to failure to meet clinical criteria, and the Provider renders the unauthorized service, the claim will deny for lack of medical necessity. Members may not be balanced billed for service claims that receive an administrative denial for failure to obtain a Prior Authorization. Please see slide 22 for more information on balance billing. 9

Prior Authorization Overview: Ordering Physician is in Network The Ordering Provider s office requesting the service is responsible for obtaining a Prior Authorization Number prior to administering the specialty drug. Prior Authorization can be requested via: Online: UnitedHealthcareOnline.com > Notifications/Prior Authorization > Specialty Drug Prior Authorization Submission & Status (Medicare Part B) Phone: 866-889-8054, and select the appropriate options for Medicare Advantage members The Ordering Provider may also verify if a Prior Authorization request has been approved by either: Checking the status online at UnitedHealthcareOnline.com > Notifications/Prior Authorization > Specialty Drug Prior Authorization Submission & Status (Medicare Part B) Calling 866-889-8054, selecting Prompt #2 and then selecting the appropriate Option for Medicare Advantage members If a primary care Provider refers a patient to a specialist, who determines that the patient needs a specialty drug that requires Prior Authorization, who is responsible to request the Prior Authorization? The Ordering Provider s office requesting the specialty drug is responsible for obtaining a Prior Authorization Number prior to any rendering of the specialty drug. In this scenario, the specialist would be responsible for obtaining the Prior Authorization. 10

Prior Authorization Overview: Ordering Physician is Non-Network If the Ordering Provider is non-network, the following options are available: Non-Network Providers can still submit a Prior Authorization either through UnitedHealthcareOnline.com, if they are registered, or by calling 866-889-8054 and selecting the option for Medicare Advantage members. The In-Network Rendering Provider may request a Prior Authorization on behalf of the Non-Network Ordering Provider by calling 866-889-8054, selecting the option for Medicare Advantage members and selecting Option 5 to speak with a Customer Care professional. The Customer Care professional will assist with obtaining an Prior Authorization Number on behalf of the Non-Network Ordering Provider. 11

Registration of In-Process Treatment In-process treatments are defined as those with a start date prior to the Specialty Drug Prior Authorization Program s effective date, utilizing one of the drugs listed and treatment is not yet complete. Providers will need to register in-process treatments for their members. Failure to register may result in an administrative claim denial. To register the member and their current treatment, Providers will need to call (866-889-8054) or go online (UnitedHealthcareOnline.com). Some of the information needed for registration is: Member s information Ordering Provider s information ICD-9 code Cancer classification Once registered, Providers will receive approval to complete the current course of treatment. The approval will be sent via fax to the Provider. This approval comes with an expiration date. Continuation of treatment beyond the expiration date or a change in treatment will require a Prior Authorization. 12

13 Initiating a Prior Authorization Request: Online To initiate a request online, go to UnitedHealthcareOnline.com (Log in using your User ID and Password) Select Notifications/Prior Authorizations > Specialty Drug Prior Authorization - Submission & Status (Medicare Part B). The Provider will then select: Corp Tax ID Provider TIN Provider Name You will then hit the Continue button You will be brought to Care Coordination Page Select Submit a Clinical Request Select the appropriate Health plan Then enter the following information: - Provider tax identification (ID) and fax number - Requested Study and/or CPT Code - Patient s ID, Group Number and date of birth (DOB) - Diagnosis Code - In the Service Information Box select Specialty Drug from the drop down menu - Clinical Information pertaining to the requested study

Initiating a Prior Authorization Request: by Phone To initiate a request by phone, call 866-889-8054, select the appropriate option for Medicare Advantage members, and then select prompt #1 Provide the following information: Member s plan name Member s name, date of birth and member ID number Ordering Provider s name, tax ID number, address, telephone and fax numbers Rendering Facility / Provider s name and address Requested test(s) (CPT J code or description) Working diagnosis Signs and symptoms Results of relevant tests Relevant medications Working diagnosis, stage, and previous therapy Member s medical records should be available when obtaining Authorization. 14

Initiating a Prior Authorization Request: Case Numbers versus Prior Authorization Numbers Case Number is assigned to every request. Case Numbers are used for reference purposes only (i.e. calling back with clinical information) The format is a 10-digit numeric value: Example: 1003456789 Case Numbers are not valid for claim payment A Prior Authorization Number will be given immediately for every case determined based off of the evidence-based clinical guidelines. A Prior Authorization Number replaces a Case Number once a determination is completed for the request The format is the letter A followed by a 9-digit numeric value and the CPT code: Example: A09123456-70450 Prior Authorization Numbers are valid for the claim payment process 15

Initiating a Prior Authorization Request: Receiving Prior Authorization Numbers Authorization Numbers are issued for both approved and denied cases/requests. Prior Authorization Numbers are communicated to the Ordering Providers or their designees: For cases initiated online or by phone: For cases that meet medical necessity criteria, Prior Authorization Numbers will be provided immediately upon the completion of the organization determination. For cases initiated online, the Prior Authorization Number will be displayed online. For cases initiated by phone, the Prior Authorization Number will be given by the Customer Care Professional while on the call. For cases that do not appear consistent with medical necessity criteria, Prior Authorization Numbers will be provided after the physician review has completed the organization determination. Once the organization determination is compete, the Prior Authorization Number will also be faxed within 15 minutes to the Ordering Provider/Designee. 16

Urgent Requests: During Normal Business Hours Ordering Providers or their designee may request a Prior Authorization Number on an urgent basis if the Provider determines it to be medically required. Urgent requests should be requested via phone: Call 866-889-8054 Select Option for Medicare Advantage members and then selecting Option 1 The Provider must state the case is clinically urgent and explain the clinical urgency when speaking with a Customer Care Professional. A Prior Authorization Number will be issued for urgent requests within three (3) hours after UnitedHealthcare receives all required information. The amount of required information is the same as the normal process Note: Prior Authorization is not required for services provided in an Inpatient, ER, or Urgent Care Clinic setting. 17

Urgent Requests: Outside of Normal Business Hours Ordering Providers or their designee may request a Prior Authorization Number on an urgent basis if the Provider determines it to be medically required. If a Specialty Drug treatment is required on an urgent basis and Prior Authorization cannot be requested because it is outside of normal business hours, the service may be performed and Authorization requested retrospectively. Services performed outside of normal business hours include services rendered on an urgent basis outside the hours of 7:00 a.m. to 7:00 p.m (all time zones) or on weekends, and or on standard U.S. national holidays. Retrospective Authorization requests must be made within two (2) business days of the provision of the service. Note: Prior Authorization is not required for services provided in an Inpatient, Emergency Room or Urgent Care Clinic setting. 18

Modifying a Prior Authorization Request Are any drug modifications allowed under the Specialty Drug Prior Authorization program? Based upon the CPT J Code Crosswalk Table, for certain specified code combinations, Providers and other health care professionals will not be required to contact the Specialty Drug Prior Authorization program to modify the existing Prior Authorization record. For Example: If J1557 is authorized then during the approved therapy time alternative drug CPT codes J1459, J1561, J1566, J1568, J1569, J1572 or J1599 may be substituted within the approved therapy time. A complete listing of codes is available at UnitedHealthcareOnline.com > Clinician Resources > Specialty Drugs: Reference Materials. What is the process to modify a Prior Authorization where either the CPT J code authorized is not present on the CPT J Code Crosswalk Table, and/or it doesn t match the drug that is needed? If an additional drug is needed the Provider must obtain a new Prior Authorization Number by calling 866-889-8054, selecting the appropriate options for Medicare Advantage members, and selecting phone prompt #2. This must be done within two (2) business days of the drug being rendered. 19 *The Rendering Provider has up to two business days from the date of service to request a modification.

Verifying Status of an Existing Prior Authorization Verify Online: Go to UnitedHealthcareOnline.com Log in with User ID and Password Select Notifications/Prior Authorizations Select Specialty Drug Prior Authorization - Submission & Status (Medicare Part B) Select the owner Provider ID, Tax ID, and name from pull down listing Select Continue and you will be brought to the Care Coordination Page Select Clinical Request Status Look Up A search may be done by using any two of the following criteria: Provider's tax ID Case Number Notification Number Member ID Verify by Phone: Call 866-889-8054 Select Option 1 to verify status using a Case Number Select Option 2 to verify status using member's ID 20

Claims Key Points Receipt of a Prior Authorization Number does not guarantee or authorize payment. Payment of the covered services is contingent upon the Member being eligible for services on the date of service, the Provider being eligible for payment, service billed appropriately, and any claim processing requirements. This requirement will not change where Providers currently submit their claims. There is no need to include the Prior Authorization Number on the claim form; however, the Provider may do so at their discretion. Specialty Drug claims administratively denied for no Prior Authorization are identified. An example would be remark code 0026 Notification Required. Procedures done as part of clinical trial are not subject to this program. Clinical trial procedure claims will need to be sent to Medicare directly. 21

Claims Key Points Continued Is Prior Authorization required when the member has UnitedHealthcare Medicare product as secondary insurance? No, Prior Authorization is not required when UnitedHealthcare Medicare Complete, UnitedHealthcare Dual Complete, UnitedHealthcare Chronic Complete or AARP Medicare Complete is secondary to any other plan. Members may not be balanced billed for service claims that receive an administrative denial for failure to obtain a Prior Authorization. Members may only be balanced billed if: Service was deemed as medically unnecessary following a Prior Authorization request and The Provider has obtained written consent from the member prior to the procedure (written consent must be specific to the service and must explain the costs). For questions about claims call 877-842-3210. 22

Thank you! Doc#: UHC1492f_20120910 23