08/14/2023
United Healthcare
United Healthcare Managed Care Committee Member
Shelby Jensen, CHONC - Newland Medical Associates
Category III CPT Codes
The American Medical Association (AMA) develops temporary Current Procedural Terminology (CPT) Category III codes to track the utilization of emerging technologies, services, and procedures. The Category III CPT code description does not establish a service or procedure as safe, effective, or applicable to the clinical practice of medicine.
READ MORE to view a list of applicable codes.
Intravenous Iron Replacement Therapy
This policy refers to the following intravenous iron replacements:
- Feraheme® (ferumoxytol)
- Injectafer® (ferric carboxymaltose)
- Monoferric® (ferric derisomaltose)*
The following intravenous iron replacements are not subject to the coverage criteria in this section:
- Ferrlecit (sodium ferric gluconate complex)
- Infed® (iron dextran)
- Venofer® (iron sucrose)
*Medical Necessity Plans
Monoferric is not medically necessary for the treatment of any diagnosis addressed within this policy (for Medicare reviews, refer to the CMS section**).
Published clinical evidence does not demonstrate superiority in the efficacy and safety of this product to other available intravenous iron replacement products.
Feraheme (ferumoxytol), Injectafer (ferric carboxymaltose), and Monoferric (ferric derisomaltose) are proven for the following indications:
Magnetic Resonance Imaging (MRI) and Computed Tomography (CT) Scan – Site of Service
A magnetic resonance imaging (MRI) or computed tomography (CT) imaging procedure in the hospital outpatient department is considered medically necessary for individuals who meet any of the following criteria:
- Under 18 years of age
- Require obstetrical observation
- Require perinatology services
- Have a known allergy to a contrast agent used for the procedure
- Have a known chronic disease undergoing active treatment, when direct comparison to prior studies requires the same imaging protocol or equipment obtained at the same hospital-based facility where the procedure is requested
- Have a systemic cancer on active treatment, when restaging studies require the same imaging protocol or equipment used for prior studies obtained at the same hospital-based facility where the procedure is requested
- Pre-procedure imaging which is done within 24 hours of the interventional or surgical procedure and is an integral part of the planned procedure
- Are scheduled for the MRI/CT imaging procedure within 24 hours of a hospital specialist appointment at the same hospitalbased facility where the procedure is requested
- Are participating in a clinical trial that requires a specific imaging protocol or equipment not available in a freestanding facility
Implantable Beta-Emitting Microspheres for Treatment of Malignant Tumors
Transarterial radioembolization (TARE) using yttrium-90 (90Y) microspheres is proven and medically necessary for the following:
- When used for the following indications:
- Primary hepatocellular carcinoma (HCC) that is unresectable and limited to the liver
- Primary hepatocellular carcinoma as a bridge to liver transplantation
- Unresectable liver metastases from neuroendocrine tumors when systemic therapy has failed to control symptoms
- Unresectable liver metastases from colorectal carcinoma in individuals with Limited Extra-Hepatic Disease who are Refractory to or relapsed following systemic chemotherapy
- Unresectable intrahepatic cholangiocarcinoma
and
- When the following criteria are met:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0,1, or 2
Transarterial radioembolization (TARE) using yttrium-90 (90Y) microspheres is unproven and not medically necessary for all other indications due to insufficient evidence of efficacy.
Durable Medical Equipment, Orthotics, Medical Supplies and Repairs/Replacements
Durable Medical Equipment (DME): Medical Equipment that is all of the following:
- Ordered or provided by a Physician for outpatient use primarily in a home setting
- Used for medical purposes
- Not consumable or disposable except as needed for the effective use of covered DME
- Not of use to a person in the absence of a disease or disability
- Serves a medical purpose for the treatment of a Sickness or injury
- Primarily used within the home
Carrier Testing Panels for Genetic Diseases
Pre-test genetic counseling is strongly recommended in order to inform persons being tested about the advantages and limitations of the test as applied to a unique person.
Breast Imaging for Screening and Diagnosing Cancer
The following are proven and medically necessary:
- Diagnostic Breast Ultrasound
- Digital mammography for individuals with dense breast tissue
- Magnetic Resonance Imaging (MRI) of the breast for individuals who are high risk for breast cancer as defined as having any of the following:
- Prior thoracic radiation therapy between the ages 10 and 30
- Lifetime risk estimated at greater than or equal to 20% as defined by models that are largely dependent on family history (e.g., Gail, Claus, Tyrer-Cuzick or BRCAPRO)
- Personal history of breast cancer (not treated with bilateral mastectomy)
- Personal history with any of the following:
- Li-Fraumeni Syndrome (TP53 mutation)
- Confirmed BRCA 1 or BRCA 2 gene mutations
- Peutz-Jehgers Syndrome (STK11, LKB1 gene variations)
- PTEN gene mutation
- Family history with any of the following:
- At least one first-degree relative who has a BRCA1 or BRCA2 mutation
First-degree relative who carries a genetic mutation in the TP53 or PTEN genes (Li-Fraumeni syndrome and Cowden and Bannayan-Riley-Ruvalcaba syndromes, or Peutz-Jehgers Syndrome) - At least two first-degree relatives with breast or ovarian cancer
- One first-degree relative with bilateral breast cancer, or both breast and ovarian cancer
- First or second-degree male relative (father, brother, uncle, grandfather) diagnosed with breast cancer
- At least one first-degree relative who has a BRCA1 or BRCA2 mutation
The following are unproven and not medically necessary due to insufficient evidence of efficacy:
- Automated Breast Ultrasound system
- Computer-Aided Detection (CAD)
- Computer-Aided Tactile Breast Imaging
- Computed Tomography (CT) of the breast
- Electrical Impedance Scanning (EIS)
- Magnetic Resonance Elastography (MRE)Magnetic Resonance Imaging (MRI) of the breast for individuals with dense breast tissue not accompanied by defined risk
factors as described above - Molecular Breast Imaging (e.g., Breast Specific Gamma Imaging, Scintimammography, Positron Emission Mammography)
Medications/Drugs (Outpatient/Part B)
Outpatient/Part B medications/drugs are covered when Medicare coverage criteria are met.
DME Face-to-Face Requirement: Section 6407 of the Affordable Care Act (ACA) established a face-to-face encounter requirement for certain items of DME (including implantable infusion pumps; implantable programmable infusion pump; external ambulatory infusion pump and nebulizers). For DME Face-to-Face Requirement information, refer to the Coverage Summary titled Durable Medical Equipment (DME), Prosthetics, Corrective Appliances/Orthotics (Non-Foot Orthotics), Nutritional Therapy, and Medical Supplies Grid.
Immune Globulin (IVIG and SCIG)
Asceni (IV), Cutaquig (SC), Cuvitru (SC), and Panzyga (IV) are typically excluded from coverage. Coverage reviews may be in place if required by law or the benefit plan. Refer to the Medical Benefit Drug Policy titled Medical Benefit Therapeutic Equivalent Medications – Excluded Drugs and the corresponding excluded drug list with preferred alternatives.
Coverage for Bivigam (IV), Carimune NF (IV), Flebogamma DIF (IV), Gammagard Liquid (IV, SC), Gammagard S/D (IV), Gammaked (IV, SC), Gammaplex (IV), Gamunex-C (IV, SC), Hizentra (SC), HyQvia (SC), Octagam (IV), Privigen (IV), and Xembify (SC) is contingent on criteria in the General Requirements and Diagnosis-Specific Criteria section.
In absence of a product listed, and in addition to applicable criteria outlined within the drug policy, prescribing and dosing information from the package insert is the clinical information used to determine benefit coverage.