Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Low Osmolar Contrast Agents
Policy #:MA09.008a

This policy is applicable to the Company’s Medicare Advantage products only. Policies that are applicable to the Company’s commercial products are accessible via a separate commercial policy database.


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.


This Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.

Low osmolar contrast agents are covered and eligible for reimbursement consideration by the Company when used in conjunction with a covered diagnostic or therapeutic procedure performed by a professional provider in the office setting.

Low osmolar contrast agents administered in the facility setting are not eligible for separate reimbursement from the diagnostic or therapeutic procedure and are included in the claim payment for the procedure.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to, records from the professional provider's office, hospital, nursing home, home health agencies, and therapies, as well as test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Policy Guidelines

This policy is consistent with Medicare's coverage criteria. The Company's payment methodology may differ from Medicare.

Description

Low osmolar contrast agents, also known as contrast media, are chemicals that enable visualization of tissues or organs by enhancing density differences between lesions and surrounding tissue during radiography or other imaging techniques.


Iodine is the only element that has proven satisfactory for general use as an intravascular contrast medium for radiography. All iodinated contrast agents have a chemical structure that is based on a benzene ring containing three iodine atoms. Reductions in osmolality, in comparison to high osmolar contrast agents, are achieved by making compounds that are nonionic monomers (i.e., iopamidol, iohexol, iversol), nonionic dimers (i.e., iodixanol, ioxilan), or monoacidic dimers (i.e., ioxaglate). Iodixanol is iso-osmolar. Low osmolar contrast agents have been used in radiological diagnosis studies when the use of other contrast material could be detrimental to an individual's health (e.g., a history of adverse reactions to contrast material; a history of asthma or allergy; significant cardiac dysfunction; generalized severe debilitation; or sickle cell disease). Low osmolar contrast agents, which include iso-osmolar agents, have a lower risk of adverse reaction than high osmolar contrast agents.


References

Adam, Andy. Grainger & Allison's Diagnostic Radiology, 2-Volume Set: A Textbook of Medical Imaging. Sixth edition.

Barrs T. Establishing safeguards for the use of imaging-related drugs. American Journal of Health-System Pharmacy. 2002;59(15):1449-1453. Available at: http://www.medscape.com/viewarticle/442004. Accessed August 15, 2019.

Brant M.D., William E, Helms M.D., Clyde A., Klein M.D. FACR, Jeffrey, Vinson M.D., Emily N. Fundamentals of Diagnostic Radiology, Fifth edition. Philadelphia: LWW; Lippincott, Williams & Wilkins, 2018.

Centers for Medicare & Medicaid Services (CMS). CMS Manual System. Transmittal 502. Pub. 100-04: Medicare claims processing: New contrast agents Healthcare Common Procedure Coding System (HCPCS) codes. [CMS Web site]. 01/13/2012. Available at: https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/R2386CP.pdf. Accessed August 15, 2019.

Centers for Medicare & Medicaid Services (CMS). Medicare Claims Processing Manual. Chapter 13: Radiology Services and Other Diagnostic Procedures. [CMS Web site]. Revised 03-27-2019. Available at:https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c13.pdf. Accessed August 15, 2019.

Centers for Medicare & Medicaid Services (CMS). MLN Matter. 3748: New Contrast Agents Healthcare Common Procedure Coding System (HCPCS) Codes. [CMS Web site]. 04/01/2005. Available at: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM3748.pdf. Accessed August 15, 2019.


Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

N/A


HCPCS Level II Code Number(s)

Q9951 Low osmolar contrast material, 400 or greater mg/ml iodine concentration, per ml


Q9965 Low osmolar contrast material, 100-199 mg/ml iodine concentration, per ml

Q9966 Low osmolar contrast material, 200-299 mg/ml iodine concentration, per ml

Q9967 Low osmolar contrast material, 300-399 mg/ml iodine concentration, per ml



Revenue Code Number(s)

N/A

Coding and Billing Requirements






Policy History

Revisions from MA00.038a:
10/09/2019This policy has been reviewed and reissued to communicate the Company’s continuing position on Low Osmolar Contrast Agents.
12/30/2015This is a policy update.

Revisions from MA00.038:
01/01/2015This is a new policy.




Version Effective Date: 12/30/2015
Version Issued Date: 12/30/2015
Version Reissued Date: 10/09/2019