UnitedHealthcare® Medicare Advantage
Policy Guideline
XOFIGO® RADIOACTIVE THERAPEUTIC AGENT
Guideline Number: MPG356.02
Table of Contents
Page
INSTRUCTIONS FOR USE .......................................... 1
POLICY SUMMARY .................................................... 1
APPLICABLE CODES ................................................. 2
REFERENCES ........................................................... 2
GUIDELINE HISTORY/REVISION INFORMATION ........... 3
Approval Date: February 8, 2017
Related Medicare Advantage Coverage Summary

Chemotherapy, and Associated Drugs and
Treatments
INSTRUCTIONS FOR USE
This Policy Guideline is applicable to UnitedHealthcare Medicare Advantage Plans offered by UnitedHealthcare and its
affiliates for health care services submitted on CMS 1500 forms and, when specified, to those billed on UB04 forms
(CMS 1450), or their electronic comparative. The information presented in this Policy Guideline is believed to be
accurate and current as of the date of publication.
This Policy Guideline provides assistance in administering health benefits. All reviewers must first identify member
eligibility, any federal or state regulatory requirements, Centers for Medicare and Medicaid Services (CMS) policy, the
member specific benefit plan coverage, and individual provider contracts prior to use of this Policy Guideline. When
deciding coverage, the member specific benefit plan document must be referenced. The terms of the member specific
benefit plan document may differ greatly from the standard benefit plan upon which this Policy Guideline is based. In
the event of a conflict, the member specific benefit plan document supersedes this Policy Guideline. Other Policies and
Guidelines may apply. UnitedHealthcare reserves the right, in its sole discretion, to modify its Policies and Guidelines
as necessary.
UnitedHealthcare follows Medicare coverage guidelines and regularly updates its Medicare Advantage Policy Guidelines
to comply with changes in CMS policy. UnitedHealthcare encourages physicians and other healthcare professionals to
keep current with any CMS policy changes and/or billing requirements by referring to the CMS or your local carrier
website regularly. Physicians and other healthcare professionals can sign up for regular distributions for policy or
regulatory changes directly from CMS and/or your local carrier. This Policy Guideline is provided for informational
purposes. It does not constitute medical advice.
POLICY SUMMARY
Overview
Xofigo (radium Ra 223 dichloride) injection is an alpha particle-emitting radioactive therapeutic agent indicated for the
treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known
visceral metastatic disease. The efficacy and safety of Xofigo were evaluated in a double-blind, randomized, placebocontrolled phase 3 clinical trial of patients with castration-resistant prostate cancer with symptomatic bone metastases.
Patients with visceral metastases and malignant lymphadenopathy exceeding 3 cm were excluded. The dose regimen
of Xofigo is 50 kBq (1.35 microcurie) per kg body weight, given at 4 week intervals for 6 injections. Safety and
efficacy beyond 6 injections with Xofigo have not been studied.
Safety and efficacy of concomitant chemotherapy with Xofigo have not been established. Outside of a clinical trial,
concomitant use of Xofigo in patients on chemotherapy is not recommended due to the potential for additive
myelosuppression. If chemotherapy, other systemic radioisotopes, or hemibody external radiotherapy are
administered during the treatment period, Xofigo should be discontinued. Xofigo is contraindicated in women who are
or may become pregnant. Xofigo can cause fetal harm when administered to a pregnant woman. Xofigo was approved
by the FDA on May 15, 2013.
Guidelines
CMS has assigned a product-specific HCPCS code for Xofigo, A9606 (Radium ra-223 dichloride, therapeutic, per
microcurie), effective January 1, 2015. Providers must purchase Xofigo and bill payers based on the number of
microcuries administered to each patient, rather than a patient-ready dose (PRD). CMS will reimburse per microcurie
billed.
Xofigo® Radioactive Therapeutic Agent
Page 1 of 3
UnitedHealthcare Medicare Advantage Policy Guideline
Approved 02/08/2017
Proprietary Information of UnitedHealthcare. Copyright 2017 United HealthCare Services, Inc.
APPLICABLE CODES
The following list(s) of codes is provided for reference purposes only and may not be all inclusive. Listing of a code in
this guideline does not imply that the service described by the code is a covered or non-covered health service.
Benefit coverage for health services is determined by the member specific benefit plan document and applicable laws
that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or
guarantee claim payment. Other Policies and Guidelines may apply.
CPT Code
79101
Description
Radiopharmaceutical therapy by IV administration
CPT® is a registered trademark of the American Medical Association
HCPCS Code
A9606
Modifier
JW
ICD-10 Diagnosis Code
C61
Description
Radium RA-223 dichloride, therapeutic, per microcurie (Effective 01/01/2015)
Description
Drug amount discarded/not administered to any patient
Description
Malignant neoplasm of prostate
AND at least one of the following:
C79.51
Secondary malignant neoplasm of bone
C79.52
Secondary malignant neoplasm of bone marrow
REFERENCES
CMS Local Coverage Determinations (LCDs)
LCD
Medicare Part A
L35053 (Chemotherapy Drugs and
AK, AL, AR, AZ, CT, FL, GA, IA, ID,
their Adjuncts) WPS
IL, IN, KS, KY, LA, MA, ME, MI, MN,
MO, MS, MT, NC, ND, NE, NH, NJ,
OH, OR, RI, SC, SD, TN, UT, VA, VI,
VT, WA, WI, WV, WY
Medicare Part B
IA, IN, KS, MI, MO, NE
CMS Articles
Article
A54559 (Xofigo Billing Instructions)
Palmetto
Medicare Part A
NC, SC, VA, WV
Medicare Part B
NC, SC, VA, WV
CMS Benefit Policy Manual
Chapter 15; § 50 Drugs and Biologicals
CMS Claims Processing Manual
Chapter 12; § 30.5 Payment for Codes for Chemotherapy Administration and Nonchemotherapy Injections and Infusions
Chapter 14; § 10 General Ambulatory Surgical Center
Chapter 17; § 90.2 Drugs, Biologicals, and Radiopharmaceuticals
CMS Transmittals
Transmittal 3163, Change Request 9021, Dated 01/09/2015 (January 2015 Update of the Ambulatory Surgical Center
(ASC) Payment System)
MLN Matters
Article MM9014, January 2015 Update of the Hospital Outpatient Prospective Payment System (OPPS)
Others
CMS HCPCS Codes for which ASP Reporting is in Units of Measure Other Than an NDC, Updated November 14, 2016,
CMS Website
CMS Medicare Hospital Outpatient PPS Addendum B Updates, January 2017, CMS Website
Coverage, Coding, & Billing for Xofigo® (radium Ra 223 dichloride) Injection Effective January 1, 2015, Xofigo Website
Xofigo Package Insert, Bayer Healthcare Pharmaceuticals Website
Xofigo® Radioactive Therapeutic Agent
Page 2 of 3
UnitedHealthcare Medicare Advantage Policy Guideline
Approved 02/08/2017
Proprietary Information of UnitedHealthcare. Copyright 2017 United HealthCare Services, Inc.
GUIDELINE HISTORY/REVISION INFORMATION
Date
02/08/2017
Action/Description

Annual review
Xofigo® Radioactive Therapeutic Agent
Page 3 of 3
UnitedHealthcare Medicare Advantage Policy Guideline
Approved 02/08/2017
Proprietary Information of UnitedHealthcare. Copyright 2017 United HealthCare Services, Inc.