Product Access Support

Helping patients gain access to treatment

If your patient with CTCL skin manifestations does not have public or private prescription coverage, meets certain income requirements, and lives in the United States, he or she may be able to receive help accessing treatment.

A program sponsored by Mallinckrodt and administered by the National Organization for Rare Disorders (NORD) may provide support for qualifying patients who cannot afford the photopheresis therapy prescribed to them. NORD is responsible for making all determinations of patient eligibility under this program. Participation in this program is available by request only and is subject to verification of financial need by NORD.

To learn more about the program and if your patient may qualify, you can send an email to photopheresis@rarediseases.org or call 1-877-241-7220 between 9:00 AM and 7:00 PM Eastern Time Monday through Thursday, and between 9:00 AM and 6:00 PM Eastern Time, on Fridays.

You can also visit www.rarediseases.org for more information.

Download this brochure for more details

Reimbursement Reference Guide

Billing and coding support for informational purposes only

The following, including all CPT* and HCPCS codes, is provided for informational purposes only, is not intended to serve as reimbursement or legal advice, and represents no statement, promise, or guarantee by Mallinckrodt that the codes are appropriate, or concerning levels of reimbursement, payment, or charge. This information is not intended to increase or maximize reimbursement by any payer. Reimbursement information is subject to change at any time and any such changes may not be reflected on this website. You should check with your specific payers to ensure that you have the most up-to-date information applicable to them, including their reimbursement policies.

It is each provider’s responsibility to determine whether the services are accurately described by any specific code(s) and to report those services consistent with specific payer requirements. In all cases, services billed must be medically necessary, actually performed as reported, and appropriately documented. You are ultimately responsible for determining the appropriate reimbursement processes and billing codes.

Outpatient payment

Medicare assigns extracorporeal photopheresis (CPT 36522) to Ambulatory Payment Classification (APC) 5243.

  • The 2020 US unadjusted Medicare payment rate is $3817.93 (actual payment rate varies by geographic locality)

Commercial insurer payment is generally based on either:

  • A flat, comprehensive rate per treatment session based on the CPT or APC

  • A fixed percentage of the hospital’s submitted charges

*CPT copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association (AMA).

Per 2020 CMS Final Rule.

Applicable Defense Federal Acquisition Regulation Supplement (DFARS) restrictions apply to government use.

Inpatient payment

Medicare payment for THERAKOS Photopheresis is subsumed under one of several Medicare Severity-Adjusted Diagnosis Related Groups (MS-DRGs) with a predetermined payment rate.
  • The MS-DRG is dictated by (1) the Cutaneous T-Cell Lymphoma (CTCL) diagnosis code (or other principal diagnosis code) and (2) the presence or absence of complications or comorbidities (CCs) or major complications and comorbidities (MCCs)

  • Your hospital’s actual payment rate under the assigned MS-DRG is influenced by a number of variables, including your area wage index, medical residency teaching activity, and volume of care to low-income patients

Commercial insurers most commonly pay for inpatient THERAKOS Photopheresis on the basis of a percentage of charges, included in a DRG rate, or included in a per diem rate.

Diagnosis and billing codes

Procedure Code Descriptor Code Type of Code
Extracorporeal photopheresis 36522 CPT-4 procedure code
Phototherapy, Circulatory, Single 6A650ZZ ICD-10 procedure code
Phototherapy, Circulatory, Multiple 6A651ZZ ICD-10 procedure code

You are ultimately responsible for determining the appropriate reimbursement strategies and billing codes.

  ICD-10 Code Fifth-Digit Subclassifications
Mycosis Fungoides C84.0
  • Unspecified site

  • Lymph nodes of head, face, and neck

  • Intrathoracic lymph nodes

  • Intra-abdominal lymph nodes

  • Lymph nodes of axilla upper limb

  • Lymph nodes of inguinal region and lower limb

  • Intrapelvic lymph nodes

  • Spleen

  • Lymph nodes of multiple sites

  • Extranodal and solid organ sites

Sézary Syndrome C84.1
 

Example: C84.18 represents Sézary syndrome with lymph node involvement in multiple sites.

 

THERAKOS Photopheresis is covered by most public and private insurers

For additional information, download the Reimbursement Reference Guide.

INDICATIONS AND USAGE

UVADEX® (methoxsalen) Sterile Solution is indicated for extracorporeal administration with the THERAKOS® UVAR XTS® or THERAKOS® CELLEX® Photopheresis System in the palliative treatment of the skin manifestations of Cutaneous T-Cell Lymphoma (CTCL) that is unresponsive to other forms of treatment.

IMPORTANT SAFETY INFORMATION

CAUTION: READ THE THERAKOS UVAR XTS or THERAKOS CELLEX PHOTOPHERESIS SYSTEMS’ OPERATOR’S MANUAL PRIOR TO PRESCRIBING OR DISPENSING THIS MEDICATION.
UVADEX (methoxsalen) Sterile Solution should be used only by physicians who have special competence in the diagnosis and treatment of Cutaneous T-Cell Lymphoma and who have special training and experience in the THERAKOS UVAR XTS or THERAKOS CELLEX Photopheresis System. Please consult the appropriate Operator's Manual before using this product.

CONTRAINDICATIONS

UVADEX is contraindicated in patients exhibiting idiosyncratic or hypersensitivity reactions to methoxsalen, other psoralen compounds, or any of the excipients. Patients possessing a specific history of a light-sensitive disease state should not initiate methoxsalen therapy.

Diseases associated with photosensitivity include lupus erythematosus, porphyria cutanea tarda, erythropoietic protoporphyria, variegate porphyria, xeroderma pigmentosum, and albinism.

UVADEX is contraindicated in patients with aphakia because of the significantly increased risk of retinal damage due to the absence of lenses.

Patients should not receive UVADEX if they have any contraindications to the photopheresis procedure.

WARNINGS AND PRECAUTIONS

  • Patients who are receiving concomitant therapy (either topically or systemically) with known photosensitizing agents such as anthralin, coal tar or coal tar derivatives, griseofulvin, phenothiazines, nalidixic acid, halogenated salicylanilides (bacteriostatic soaps), sulfonamides, tetracyclines, thiazides, and certain organic staining dyes such as methylene blue, toluidine blue, rose bengal, and methyl orange may be at greater risk for photosensitivity reactions with UVADEX

  • Oral administration of methoxsalen followed by cutaneous UVA exposure (PUVA therapy) is carcinogenic. Methoxsalen also causes DNA damage, interstrand cross-links and errors in DNA repair

  • Methoxsalen may cause fetal harm when given to a pregnant woman. There are no adequate and well-controlled studies of methoxsalen in pregnant women. If UVADEX is used during pregnancy, or if the patient becomes pregnant while receiving UVADEX, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant. It is not known whether this drug is excreted in human milk

  • After methoxsalen administration, exposure to sunlight and/or ultraviolet radiation may result in "premature aging" of the skin

  • Since oral psoralens may increase the risk of skin cancers, monitor closely those patients who exhibit multiple basal cell carcinomas or who have a history of basal cell carcinomas

  • Serious burns from either UVA or sunlight (even through window glass) can result if the recommended dosage of methoxsalen is exceeded or precautions are not followed

  • Patients should be advised to avoid all exposure to sunlight during the 24 hours following photopheresis treatment

  • Exposure to large doses of UVA light causes cataracts in animals. Oral methoxsalen exacerbates this toxicity. Serum methoxsalen concentrations are substantially lower after extracorporeal UVADEX treatment than after oral methoxsalen treatment. Nevertheless, if the lens is exposed to UVA light while methoxsalen is present, photoactivation of the drug may cause adducts to bind to biomolecules within the lens

  • Instruct patients emphatically to wear UVA-absorbing, wrap-around sunglasses for 24 hours after UVADEX treatment

  • Safety in children has not been established

  • Thromboembolic events, such as pulmonary embolism and deep vein thrombosis, have been reported with UVADEX administration through photopheresis systems for treatment of patients with graft-versus-host disease, a disease for which UVADEX is not approved.

ADVERSE REACTIONS

Side effects of photopheresis (UVADEX used with the THERAKOS Photopheresis System) were primarily related to hypotension secondary to changes in extracorporeal volume (>1%)
For the THERAKOS® UVAR XTS®/CELLEX® Photopheresis Procedure:

INDICATIONS

The THERAKOS UVAR XTS Photopheresis System/THERAKOS CELLEX Photopheresis System is indicated for use in the ultraviolet-A (UVA) irradiation, in the presence of the photoactive drug 8-methoxypsoralen (8-MOP®), of extracorporeally circulating leukocyte-enriched blood, in the palliative treatment of the skin manifestations of Cutaneous T-Cell Lymphoma (CTCL), in persons who have not been responsive to other forms of treatment.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

The THERAKOS UVAR XTS or THERAKOS CELLEX Photopheresis Systems are not designated, sold, or intended for use except as indicated.

Certain underlying medical conditions contraindicate THERAKOS Photopheresis, including patients:

  • who cannot tolerate extracorporeal volume loss during the leukocyte-enrichment phase

  • exhibiting idiosyncratic or hypersensitivity reactions to 8-methoxypsoralen/psoralen compounds

  • with coagulation disorders

  • who have had previous splenectomy

WARNINGS AND PRECAUTIONS

  • THERAKOS Photopheresis treatments should always be performed in locations where standard medical emergency equipment is available. Volume replacement fluids and/or volume expanders should be readily available throughout the procedure

  • Patients who may not be able to tolerate the fluid changes associated with extracorporeal photopheresis should be monitored carefully

  • Procedures, such as renal dialysis, which might cause significant fluid changes (and expose the patient to additional anticoagulation) should not be performed on the same day as extracorporeal photopheresis

  • Individual patients may require a heparin dosage that varies from the recommended dose to prevent post-treatment bleeding or clotting during a treatment

ADVERSE REACTIONS

  • Hypotension may occur during any treatment involving extracorporeal circulation. Closely monitor the patient during the entire treatment for hypotension

  • Transient pyretic reactions, 37.7-38.9°C (100-102°F), have been observed in some patients within six to eight hours of reinfusion of the photoactivated leukocyte-enriched blood. A temporary increase in erythroderma may accompany the pyretic reaction

  • Treatment frequency exceeding labeling recommendations may result in anemia

  • Venous access carries a small risk of infection and pain

Please see accompanying Full Prescribing Information, including the BOXED WARNING for UVADEX, and see the appropriate THERAKOS Photopheresis System Operator’s Manual.
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