RETIRED DRUG POLICY Policy Number 2017D0034A Maximum Drug Dose Policy Annual Approval Date 3/1/2017 Approved By UnitedHealthcare National Pharmacy & Therapeutics Committee United Healthcare Community Plan Payment Policy Committee IMPORTANT NOTE ABOUT THIS REIMBURSEMENT POLICY You are responsible for submission of accurate claims. This reimbursement policy is intended to ensure that you are reimbursed based on the code or codes that correctly describe the health care services provided. UnitedHealthcare Community Plan reimbursement policies uses Current Procedural Terminology (CPT *), Centers for Medicare and Medicaid Services (CMS) or other coding guidelines. References to CPT or other sources are for definitional purposes only and do not imply any right to reimbursement. This reimbursement policy applies to all health care services billed on CMS 1500 forms and, when specified, to those billed on UB04 forms. Coding methodology, industry-standard reimbursement logic, regulatory requirements, benefits design and other factors are considered in developing reimbursement policy. This information is intended to serve only as a general reference resource regarding UnitedHealthcare Community Plan s reimbursement policy for the services described and is not intended to address every aspect of a reimbursement situation. Accordingly, UnitedHealthcare Community Plan may use reasonable discretion in interpreting and applying this policy to health care services provided in a particular case. Further, the policy does not address all issues related to reimbursement for health care services provided to UnitedHealthcare Community Plan enrollees. Other factors affecting reimbursement supplement, modify or, in some cases, supersede this policy. These factors include, but are not limited to: federal &/or state regulatory requirements, the physician or other provider contracts, the enrollee s benefit coverage documents, and/or other reimbursement, medical or drug policies. Finally, this policy may not be implemented exactly the same way on the different electronic claims processing systems used by UnitedHealthcare Community Plan due to programming or other constraints; however, UnitedHealthcare Community Plan strives to minimize these variations. UnitedHealthcare Community Plan may modify this reimbursement policy at any time by publishing a new version of the policy on this Website. However, the information presented in this policy is accurate and current as of the date of publication. (*CPT is a registered trademark of the American Medical Association) Application This drug policy applies to UnitedHealthcare Community Plan Medicaid Product. This reimbursement policy applies to services reported using the 1500 Health Insurance Claim Form (a/k/a ) or its electronic equivalent or its successor form. This policy applies to all products and all network and non-network physicians and other qualified health care professionals, including, but not limited to, non-network authorized and percent of charge contract physicians and other qualified health care professionals. Payment Policies for Medicare & Retirement, UnitedHealthcare Community Plan Medicare and Employer & Individual please use this link. Medicare & Retirement and UnitedHealthcare Community Plan Medicare Policies are listed under Medicare Advantage Reimbursement Policies. Employer & Individual are listed under Reimbursement Policies-Commercial.
Policy Overview This policy provides information about the maximum dosage per administration for certain specialty pharmacy medications administered by a medical professional. Drug Products: Bevacizumab (Avastin ) Infliximab (Remicade ) Infliximab-dyyb (Inflectra ) Pegfilgrastim (Neulasta ) Rituximab (Rituxan ) Trastuzumab (Herceptin ) Ustekinumab (Stelara ) Zoledronic acid (, Reclast and Zometa ) The pharmaceuticals included in this policy all have dosing parameters that support a maximum dosage per body weight or body surface area or a set maximal dosage independent of patient body size. These maximum doses are product-specific, and in some cases, disease state-specific and are defined in the U.S. Food and Drug Administration (FDA) approved product prescribing information and/or in national compendia and other peer reviewed resources. This policy creates an upper dose limit based on the clinical evidence and the 95 th percentile for adult body weight in the U.S. (114 kg or 2.38 meters 2 ). (McDowell, 2008) Clinical evidence supports the use of the medications listed in this policy up to maximum dosages based upon body surface area or patient weight, when used according to labeled indications or when otherwise supported by published clinical evidence. Clinical evidence does not support the use of the medications listed in this policy beyond maximum dosages based upon body surface area or patient weight. Use of these agents beyond such established maximum dosages adds significantly to risk of adverse events without conferring additional clinical benefit. Reimbursement Guidelines Most medications have a maximum dosage based upon body surface area or patient weight or a set maximal dosage independent of patient body size, and are proven when used according to labeled indications or when otherwise supported by published clinical evidence. The medications included in this policy when given beyond maximum dosages based upon body surface area or patient weight or a set maximal dosage independent of patient body size are not supported by package labeling or published clinical evidence and are unproven. J Code Based Maximum Dosage Information: Medication Name Maximum Dosage Brand Generic per Administration HCPCS Code Avastin bevacizumab 15 mg/kg J9035 Herceptin trastuzumab 8 mg/kg J9355 Neulasta pegfilgrastim 6 mg total dose J2505 Reclast Zoledronic Acid 5 mg total dose 5 mg total dose J3489 Maximum Allowed 179 HCPCS units (10 mg 95 HCPCS units (10 mg 1 HCPCS unit (6 mg per unit) 5 HCPCS units (1 mg per unit)
Zometa 4 mg total dose Zoledronic Acid 4 mg total dose Remicade infliximab 10 mg/kg J1745 Inflectra infliximab-dyyb 10 mg/kg Q5102 Rituxan rituximab 1,225 mg total dose J9310 Stelara ustekinumab 90 mg J3357 119 HCPCS units (10 mg 119 HCPCS units (10 mg 13 HCPCS units (100 mg 90 HCPCS units (1 mg per unit) Maximum Allowed Quantities for National Drug Code (NDC) Billing: This information only applies to select providers billing medical claims by National Drug Code (NDC). The allowed quantities in this section are calculated based upon both the maximum dosage information supplied within this policy as well as the process by which NDC claims are billed. This list may not be inclusive of all available NDC s for each drug product and is subject to change. Medication Name Brand Generic Avastin bevacizumab Avastin bevacizumab Herceptin trastuzumab Herceptin trastuzumab Inflectra infliximab-dyyb Neulasta pegfilgrastim Neulasta pegfilgrastim Neulasta pegfilgrastim Reclast Reclast Remicade infliximab Rituxan rituximab Rituxan rituximab Stelara ustekinumab Stelara ustekinumab How Supplied 100 mg/4 ml solution in 400 mg/16 ml solution in 440 mg powder for 440 mg powder for 100 mg powder for 6 mg/0.6 ml prefilled 6 mg/0.6 ml prefilled 6 mg/0.6 ml prefilled with on-body Injector 5 mg/100 ml solution in 5 mg/100 ml solution in 100 mg powder for 100 mg/10 ml solution in 500 mg/50 ml solution in 45 mg/0.5 ml prefilled 45 mg/0.5 ml solution in National Drug Code Maximum Allowed 50242-0060-01 72 ml 50242-0061-01 72 ml 50242-0056-56 3 50242-0134-68 3 32228-0001-01 12 54868-5229-00 0.6 ml 55513-0190-01 0.6 ml 55513-0190-01 0.6 ml 00078-0435-61 100 ml 35356-0351-01 100 ml 57894-0030-01 12 50242-0051-21 130 ml 50242-0053-06 130 ml 57894-0060-03 0.5 ml 57894-0060-02 0.5 ml
Stelara ustekinumab 90 mg/1 ml prefilled 5 mg/100 ml solution in 4 mg/5 ml solution in 4 mg/5 ml lyophilisate for solution for injection in 4 mg/100 ml solution in DRUG POLICY 57894-0061-03 1 ml 25021-0830-82 42023-0163-01 43598-0331-11 23155-0186-31 55111-0688-52 00143-9642-01 47335-0035-40 25021-0801-66 42023-0151-01 43598-0330-11 53150-0871-01 23155-0170-31 55111-0685-07 60505-6110-00 45963-0440-55 100 ml 5 ml 47335-0962-41 5 ml 25021-0826-82 100 ml Zometa 4 mg/5 ml solution in 00078-0387-25 5 ml Zometa 4 mg/100 ml solution in 00078-0590-61 100 ml Centers for Medicare and Medicaid Services (CMS): Medicare does not have a National Coverage Determination (NCD) that address maximum dosage for infliximab, rituximab, bevacizumab, trastuzumab, pegfilgrastim, and. Local Coverage Determinations (LCDs) exist for the following drugs and compliance with these policies is required where applicable. These LCDs are available at http://www.cms.gov/medicare-coverage-database/overview-andquick-search.aspx. Infliximab o Drugs and Biologicals: Infliximab and Remicade o Infliximab (Remicade) Rituximab o Rituximab (Rituxan) o Drugs and Biologicals: Rituximab (Rituxan) Bevacizumab o Drugs and Biologicals: Bevacizumab (Avastin) o Intravitreal Bevacizumab (Avastin) Trastuzumab o Trastuzumab (Herceptin) Pegfilgrastim o Pegfilgrastim (Neulasta) Zoledronic acid o Drugs and Biologicals: Zoledronic Acid (Accessed April 24, 2013)
State Exceptions Arizona This policy is not applicable to this Medicaid plan due to specific state requirements related to Maximum Frequency per Day units. Questions and Answers 1 Q: Will the claim completely deny if the units on the claim exceed the maximum? A: No. The claim will pay for the units up to, and including the maximum number allowed. HCPCS Code J1745 J2505 J3357 J3489 J9035 J9310 J9355 Q5102 Description Injection, infliximab, excludes biosimilar, 10 mg Injection, pegfilgrastim, 6 mg Ustekinumab, for subcutaneous injection, 1mg Injection,, 1 mg Injection, bevacizumab, 10 mg Injection, rituximab, 100 mg Injection, trastuzumab, 10 mg Injection, infliximab, biosimilar, 10 mg National Drug Code Description 50242-0060-01 Avastin 100 mg/4 ml solution in 50242-0061-01 Avastin 400 mg/16 ml solution in 50242-0056-56 Herceptin 440 mg powder for 50242-0134-68 Herceptin 440 mg powder for 32228-0001-01 Inflectra 100 mg powder for 55513-0190-01 Neulasta 6 mg/0.6 ml prefilled 54868-5229-00 Neulasta 6 mg/0.6 ml prefilled 00078-0435-61 Reclast 5 mg/100 ml solution in 35356-0351-01 Reclast 5 mg/100 ml solution in 57894-0030-01 Remicade 100 mg powder for 50242-0051-21 Rituxan 100 mg/10 ml solution in 50242-0053-06 Rituxan 500 mg/50 ml solution in 57894-0060-03 Stelara 45 mg/0.5 ml prefilled 57894-0060-02 Stelara 45 mg/0.5 ml solution in 57894-0061-03 Stelara 90 mg/1 ml prefilled 25021-0830-82 Zoledronic Acid 5 mg/100 ml solution in 42023-0163-01 Zoledronic Acid 5 mg/100 ml solution in 43598-0331-11 Zoledronic Acid 5 mg/100 ml solution in 23155-0186-31 Zoledronic Acid 5 mg/100 ml solution in 55111-0688-52 Zoledronic Acid 5 mg/100 ml solution in 00143-9642-01 Zoledronic Acid 4 mg/5 ml solution in 47335-0035-40 Zoledronic Acid 4 mg/5 ml solution in 25021-0801-66 Zoledronic Acid 4 mg/5 ml solution in
National Drug Code Description 42023-0151-01 Zoledronic Acid 4 mg/5 ml solution in 43598-0330-11 Zoledronic Acid 4 mg/5 ml solution in 53150-0871-01 Zoledronic Acid 4 mg/5 ml solution in 23155-0170-31 Zoledronic Acid 4 mg/5 ml solution in 55111-0685-07 Zoledronic Acid 4 mg/5 ml solution in 60505-6110-00 Zoledronic Acid 4 mg/5 ml solution in 45963-0440-55 Zoledronic Acid 4 mg/5 ml solution in DRUG POLICY 47335-0962-41 Zoledronic Acid 4 mg/5 ml lyophilisate for solution for injection in 25021-0826-82 Zoledronic Acid 4 mg/100 ml solution in 00078-0387-25 Zometa 4 mg/5 ml solution in 00078-0590-61 Zometa 4 mg/100 ml solution in Resources Individual state Medicaid regulations, manuals & fee schedules American Medical Association, Current Procedural Terminology ( CPT ) Professional Edition and associated publications and services Centers for Medicare and Medicaid Services, Healthcare Common Procedure Coding System, HCPCS Release and Code Sets References 1. Constantine S. Tam, Susan O'Brien, William Wierda, Hagop Kantarjian, Sijin Wen, Kim-Anh Do, Deborah A. Thomas, Jorge Cortes, Susan Lerner, and Michael J. Keating. Long-term results of the fludarabine, cyclophosphamide, and rituximab regimen as initial therapy of chronic lymphocytic leukemia. Blood 2008; 112: 975-980. 2. Fryar CD, Gu Q, Ogden CL. Anthropometric Reference Data for Children and Adults: United States, 2007-2010. National Health Statistics Reports; Series 11: Number 252. Hyattsville, MD: National Center for Health Statistics. October 2012. 3. Herceptin [package insert]. South San Francisco, CA: Genentech, Inc.; October 2010. 4. Neulasta [package insert]. Thousand Oaks, CA: Amgen Inc.; June 2011. 5. Reclast [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; August 2011. 6. Remicade [package insert]. Horsham, PA: Janssen Biotech Inc.; October 2011. 7. Rituxan [package insert]. South San Francisco, CA: Genentech, Inc.; October 2012. 8. Zometa [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; November 2012. History 10/1/2017 Policy Retired
7/18/2017 Application Section: Removed UnitedHealthcare Community Plan Medicare products as applying to this policy. Added location for UnitedHealthcare Community Plan Medicare reimbursement policies 3/5/2017 Policy Overview Section: Updated Drug Products Reimbursement Guidelines Section: J Code Based Maximum Dosage Information table updated Removed Codes Section. Added HCPCS and National Drug Code Tables 7/28/16 Annual Approval Date: Revised 3/15/2016 Annual Approval Date: Revised State Exceptions Section: Exception added for Pennsylvania 1/1/2016 Annual Policy Version Change History Section: Entries prior to 1/1/2014 archived 1/1/2015 Annual Version Change History Section: Entries prior to 1/1/13 archived. 8/4/2014 Application Section: Added including, but not limited to verbiage and added verbiage stating this policy applies to UnitedHealthcare Community Plan Medicaid and Medicare products. 3/31/2014 Disclaimer: Revised 1/27/2014 Annual renewal of policy approved 1/1/2014 Annual Version Change Policy updated with code J3489, effective on 1/1/2014. Removed inactive codes J3487 and J3488. 5/13/2012 Policy implemented by UnitedHealthcare Community & State