Local Coverage Determination (LCD)

Tumor Treatment Field Therapy (TTFT)

L34823

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Contractor Information

Contractor Name	Contract Type	Contract Number	Jurisdiction	States
CGS Administrators, LLC	DME MAC	17013 - DME MAC	J-B	Illinois Indiana Kentucky Michigan Minnesota Ohio Wisconsin
CGS Administrators, LLC	DME MAC	18003 - DME MAC	J-C	Alabama Arkansas Colorado Florida Georgia Louisiana Mississippi New Mexico North Carolina Oklahoma Puerto Rico South Carolina Tennessee Texas Virgin Islands Virginia West Virginia
Noridian Healthcare Solutions, LLC	DME MAC	16013 - DME MAC	J-A	Connecticut Delaware District of Columbia Maine Maryland Massachusetts New Hampshire New Jersey New York - Entire State Pennsylvania Rhode Island Vermont
Noridian Healthcare Solutions, LLC	DME MAC	19003 - DME MAC	J-D	Alaska American Samoa Arizona California - Entire State Guam Hawaii Idaho Iowa Kansas Missouri - Entire State Montana Nebraska Nevada North Dakota Northern Mariana Islands Oregon South Dakota Utah Washington Wyoming

LCD Information

Document Information

LCD ID
L34823

LCD Title
Tumor Treatment Field Therapy (TTFT)

Proposed LCD in Comment Period
N/A

Source Proposed LCD
DL34823

Original Effective Date
For services performed on or after 10/01/2015

Revision Effective Date
For services performed on or after 01/01/2020

Revision Ending Date
N/A

Retirement Date
N/A

Notice Period Start Date
07/18/2019

Notice Period End Date
08/31/2019

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CMS National Coverage Policy

N/A

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements.

The purpose of a Local Coverage Determination (LCD) is to provide information regarding “reasonable and necessary” criteria based on Social Security Act § 1862(a)(1)(A) provisions.

In addition to the “reasonable and necessary” criteria contained in this LCD there are other payment rules, which are discussed in the following documents, that must also be met prior to Medicare reimbursement:

The LCD-related Standard Documentation Requirements Article, located at the bottom of this policy under the Related Local Coverage Documents section.
The LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.
Refer to the Supplier Manual for additional information on documentation requirements.
Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.

For the items addressed in this LCD, the “reasonable and necessary” criteria, based on Social Security Act § 1862(a)(1)(A) provisions, are defined by the following coverage indications, limitations and/or medical necessity.

INITIAL COVERAGE FOR NEWLY DIAGNOSED GLIOBLASTOMA MULTIFORME:

Tumor treatment field therapy (E0766) is covered for the treatment of newly diagnosed Glioblastoma Multiforme (GBM) only when all of the following criteria are met:

The beneficiary has histologically confirmed (World Health Organization (WHO) grade IV astrocytoma), newly diagnosed, supratentorial GBM; and,
The beneficiary has received initial treatment with maximal debulking surgery (when feasible), followed by chemotherapy and radiotherapy; and,
Tumor treatment field therapy is initiated within 7 weeks from the last dose of concomitant chemotherapy or radiotherapy, whichever is later; and,
The beneficiary has no evidence of progression by Response Assessment in Neuro-Oncology (RANO) criteria; and,
The beneficiary has a Karnofsky Performance Score (KPS) of at least 70; and,
The beneficiary will use TTFT for an average of 18 hours per day.

If all of the coverage criteria above are not met, claims for code E0766 will be denied as not reasonable and necessary.

CONTINUED COVERAGE FOR NEWLY DIAGNOSED GBM BEYOND THE FIRST THREE MONTHS OF THERAPY:

Continued coverage of TTFT (E0766) beyond the first three months of therapy requires that no sooner than the 60th day but no later than the 91st day after initiating therapy, the treating practitioner must conduct a clinical re-evaluation and document that the beneficiary is continuing to use and is benefiting from TTFT.

Documentation of clinical benefit is demonstrated by:

In-person clinical re-evaluation by the treating practitioner; and,
Objective evidence of adherence to therapy, reviewed by the treating practitioner.

Adherence to therapy is defined as the use of TTFT for an average of 18 hours per day (excluding days the treating practitioner has documented a medical need to limit or interrupt treatment).

If the above criteria are not met, continued coverage of TTFT will be denied as not reasonable and necessary.

If the practitioner re-evaluation does not occur until after the 91st day but the evaluation demonstrates that the beneficiary is benefiting from TTFT as defined in criteria 1 and 2 above, continued coverage of TTFT will commence with the date of that re-evaluation. See Policy Specific Documentation Requirements in the LCD-related Policy Article, located in the Related Local Coverage Documents section of this LCD, for information about KX modifier use.

RECURRENT GBM

Tumor treatment field therapy (E0766) will be denied as not reasonable and necessary for the treatment of recurrent GBM.

OTHER USES

The use of TTFT for any indications other than newly diagnosed GBM will be denied as not reasonable and necessary.

BENEFICIARIES ENTERING MEDICARE

For beneficiaries who are undergoing treatment with TTFT for newly diagnosed, supratentorial GBM prior to enrollment in Fee-For-Service (FFS) Medicare and are seeking Medicare coverage of TTFT, coverage will be provided if all of the following coverage requirements are met:

The beneficiary has been receiving TTFT following initial maximal debulking surgery (if feasible) followed by chemotherapy/radiotherapy for histologically confirmed newly diagnosed GBM; and,
Clinical Evaluation – Following enrollment in FFS Medicare, the beneficiary must have an in-person evaluation by their treating practitioner who documents in the beneficiary’s medical record that:
1. The beneficiary is adherent with the use of TTFT for an average of 18 hours per day; and,
2. The beneficiary is deriving benefit from the therapy.

If all of the above are not met, the claim will be denied as not reasonable and necessary.

GENERAL

A Standard Written Order (SWO) must be communicated to the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving a completed SWO, the claim shall be denied as not reasonable and necessary.

For Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) base items that require a Written Order Prior to Delivery (WOPD), the supplier must have received a signed SWO before the DMEPOS item is delivered to a beneficiary. If a supplier delivers a DMEPOS item without first receiving a WOPD, the claim shall be denied as not reasonable and necessary. Refer to the LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.

For DMEPOS base items that require a WOPD, and also require separately billed associated options, accessories, and/or supplies, the supplier must have received a WOPD which lists the base item and which may list all the associated options, accessories, and/or supplies that are separately billed prior to the delivery of the items. In this scenario, if the supplier separately bills for associated options, accessories, and/or supplies without first receiving a completed and signed WOPD of the base item prior to delivery, the claim(s) shall be denied as not reasonable and necessary.

An item/service is correctly coded when it meets all the coding guidelines listed in CMS HCPCS guidelines, LCDs, LCD-related Policy Articles, or DME MAC articles. Claims that do not meet coding guidelines shall be denied as not reasonable and necessary/incorrectly coded.

Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are required to maintain POD documentation in their files. Proof of delivery documentation must be made available to the Medicare contractor upon request. All services that do not have appropriate proof of delivery from the supplier shall be denied as not reasonable and necessary.

Summary of Evidence

Support for TTFT in the treatment of newly diagnosed GBM stems from a study by Stupp et al. (2017), also referred to as the EF-14 study. The EF-14 study was a randomized, open-label trial of 695 patients with histologically-confirmed glioblastoma multiforme (World Health Organization (WHO) grade IV astrocytoma) whose tumor was resected or biopsied and had completed concomitant radiochemotherapy and TTFT. Of the 695 randomized patients, 637 (92%) completed the trial. Median progression-free survival from randomization was 6.7 months in the TTFT-temozolomide group vs 4.0 months in the temozolomide-alone group (HR, 0.63; 95% CI, 0.52-0.76; P < .001). Median overall survival was 20.9 months in the TTFT-temozolomide group vs 16.0 months in the temozolomide-alone group (HR, 0.63; 95% CI, 0.53-0.76; P < .001). Systemic adverse events were similar between the two study arms. Mild to moderate skin toxicity underneath the transducer arrays occurred in 52% of patients who received TTFT-temozolomide vs no patients who received temozolomide alone.

The National Comprehensive Cancer Network assigns TTFT a Category 1 recommendation as a treatment option for newly diagnosed GBM, following initial maximal debulking surgery (when feasible), chemotherapy, and radiation therapy.

Analysis of Evidence (Rationale for Determination)

Background

Glioblastoma, also known as glioblastoma multiforme (GBM) is an aggressive type of brain cancer. It is rare, with an incidence of 3.21 cases per 100,000 population per year in the US.

Alternating electric fields are produced by a pulse generator and transmitted by ceramic transducers placed on a patient’s head. Tumor Treatment Field Therapy (TTFT) uses alternating electric fields to target cancer cells. The electric fields reportedly attract and repel charged proteins during cancer cell division. Cellular proteins, because they are highly polarized, are presumed to be prevented from moving to their correct locations thus disrupting cancer cell division.

NEWLY DIAGNOSED GBM

In October 2015 the FDA expanded the marketing indications for TTFT to include newly diagnosed GBM (see https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100034S013). In 2018 the DME MACs received a request to cover TTFT for newly diagnosed GBM.

Contractor Advisory Committee (CAC)

Following an independent review of the literature, the DME MACs assembled a 13-member specialty-focused CAC, comprised of a national panel of neuro-oncologists, neurosurgeons and experts in the field of oncologic treatment. The CAC meeting was held on March 6, 2019 in Baltimore, Maryland. Five (5) Key Questions were discussed by the CAC members, and confidence in each Key Question scored (Chair and Industry Representative were excluded from scoring). Confidence was rated on a scale of 1-5, with 1 indicative of low confidence and 5 indicating high confidence.

The following is a summary of the CAC Panel scoring for each Key Question and the related discussion.

1.	How confident are you that there is sufficient evidence to determine that TTFT for newly diagnosed GBM can provide net positive health outcomes in the Medicare-eligible population?	Scoring Member Average
	1 Low Confidence — 2 — 3 Intermediate — 4 — 5 High Confidence	3.82
The members noted that both Progression Free Survival (PFS) and Overall Survival (OS) were both increased in the EF-14 treatment arm, and migrated together, for both Medicare age eligible and non-eligible populations, in spite of the small group of the latter. Comments were made as to what constitutes adequate PFS and OS, and there was acknowledgement that additional months of improved quality of life in a disease such as GBM is a desirable outcome. Several substantial concerns were raised in regard to net positive health outcomes. Two were related to study design, one to the philosophical approach to assessment of a new technology, and one to concerns related to conflicts of interest. In spite of the relative consensus on the goodness of metrics to reflect positive health outcomes, significant concerns were expressed at the study design, lack of sham control group and data gaps regarding volume of study subjects, subset analyses and the lack of corroborative additional clinical study. There was also discussion but not consensus as to whether or not the bar should be higher for net positive health outcomes for such a new technology. Additional concerns were related to the lack of clarity regarding clinical mechanism of action and concerns regarding delivery and dose effect, and geographical localization of the treatment field. Concerns related to potential conflict of interest in study funding and analyses were also discussed.
2.	How confident are you that the available evidence demonstrates adequate predictors of success in Medicare-eligible population?	Scoring Member Average
	1 Low Confidence — 2 — 3 Intermediate — 4 — 5 High Confidence	3.45
When considering this question, there was repeated discussion of volume and data gaps. The most substantial concern revolved around the smallness of the Medicare age eligible subpopulation. There was consensus that predictors of response in the age eligible Medicare population were sparse.
3.	How confident are you that TTFT is generally accepted by the medical community for newly diagnosed GBM?	Scoring Member Average
	1 Low Confidence — 2 — 3 Intermediate — 4 — 5 High Confidence	2.91
This question generated the most concerns regarding how the standard of care was established, how the provider community was defined and segmented, and what conflicts may contribute to drive adoption. There was consensus that guidelines are just one factor in the determination as to whether TTF is generally accepted in the medical community. In balance the group did think that regardless of how practitioners were notified of the availability of TTF for GBM, there was broad superficial penetration in the USA community, but that its acceptance as standard of care or generally accepted practice was not clear.
4.	How confident are you that scientific evidence supports mitotic spindle disruption and cellular apoptosis as the mechanism of action of TTFT?	Scoring Member Average
	1 Low Confidence — 2 — 3 Intermediate — 4 — 5 High Confidence	3.27
There was discussion here as to the lack of actual human data to demonstrate the mechanism of action, but consensus that there was a plethora of preclinical data did uniformly seem to demonstrate mitotic spindle disruption and apoptosis as a mechanism of action of tumor cell death.
5.	How confident are you that there are no significant evidence gaps that may impact positive health outcomes in the Medicare-eligible population?	Scoring Member Average
	1 Low Confidence — 2 — 3 Intermediate — 4 — 5 High Confidence	2.91
There was consensus in the group that there remained significant gaps in evidence that the CAC members would like to see explored, either through controlled trials or in a real world evidence study paradigms. There was consensus that more data is needed to identify the place of TTFT in therapy across a more broad range of patient population and within the treatment algorithm for GBM and to further explore its mechanism of action, prognostic features, and predictors of response. There was discussion of the need to review the evolving evidence rapidly since the standard of care evolves so rapidly in this area. There was consensus that more data is needed to identify the place of TTFT in therapy across a more broad range of patient population and within the treatment algorithm for GBM and to further explore its mechanism of action, prognostic features, and predictors of response. Specific additional areas recommended for study included: Dose density and power Demographic diversity of subjects Prognostic indicators Impact on caretakers More on quality of life Medical economic assessment The best sequencing of treatment including where in the algorithm is TTFT best placed Exploration of the human mechanism of action

CONCLUSION

The use of TTFT for the treatment of newly diagnosed GBM appears to be gaining acceptance in the neuro-oncology community in the United States. The coverage requirements outlined above reflect the currently published literature with regard to criteria that best ensure optimal outcomes for Medicare beneficiaries with newly diagnosed GBM.

RECURRENT GBM

In April 2011 the Food and Drug Administration (FDA) approved the marketing of the NovoTTF-100A (later rebranded Optune^®) for the treatment of recurrent GBM. The original LCD for TTFT was effective in August 2014, following an Open Meeting and solicitation of public comments. The DME MACs determined that, based on the strength and quality of the evidence available at that time, TTFT was not reasonable and necessary for the treatment of GBM.

In 2018 the DME MACs received a request to reconsider the decision on recurrent GBM. The requestor, Novocure, did not submit new evidence in support of revised coverage for recurrent disease. Consequently, pursuant to Chapter 13 of the CMS Program Integrity Manual (CMS Pub. 100-08), the DME MACs determined that the request was invalid.

Proposed Process Information

Synopsis of Changes

Changes	Fields Changed
	N/A

Associated Information

Sources of Information

Bibliography

Open Meetings

Contractor Advisory Committee (CAC) Meetings

MAC Meeting Information URLs

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	View Letter

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Coding Information

Bill Type Codes

Code	Description
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Revenue Codes

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General Information

Associated Information

DOCUMENTATION REQUIREMENTS

Section 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider.” It is expected that the beneficiary's medical records will reflect the need for the care provided. The beneficiary's medical records include the treating practitioner's office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.

GENERAL DOCUMENTATION REQUIREMENTS

In order to justify payment for DMEPOS items, suppliers must meet the following requirements:

SWO
Medical Record Information (including continued need/use if applicable)
Correct Coding
Proof of Delivery

Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information regarding these requirements.

Refer to the Supplier Manual for additional information on documentation requirements.

Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.

POLICY SPECIFIC DOCUMENTATION REQUIREMENTS

Items covered in this LCD have additional policy-specific requirements that must be met prior to Medicare reimbursement.

Refer to the LCD-related Policy article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information.

Appendices

Utilization Guidelines

Refer to Coverage Indications, Limitations and/or Medical Necessity

Sources of Information

Food and Drug Administration. Summary of Safety and Effectiveness Data. PMA P100034/S013. Novocure TTF-100A. October 5, 2015.

National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Central Nervous System Cancers. Version 2.2018 November 26, 2018. Accessed January 3, 2019.

National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Central Nervous System Cancers. NCCN Evidence Blocks™. Version 2.2018 November 26, 2018. Accessed January 3, 2019.

Stupp R, Taillibert S, Kanner A, et al. Effect of Tumor-Treating Fields Plus Maintenance Temozolomide vs Maintenance Temozolomide Alone on Survival in Patients With Glioblastoma: A Randomized Clinical Trial. JAMA. 2017;318(23):2306-2316.

Bibliography

The following bibliography was provided to the Contractor Advisory Committee (CAC) for their consideration of Tumor Treatment Field Therapy for the treatment of newly diagnosed glioblastoma multiforme.

Submitted by Novocure with Reconsideration Request

National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Central Nervous System Cancers. NCCN Flash Card™. Version 1.2018 March 20, 2018.

Stupp R, Taillibert S, Kanner AA, et al. Maintenance Therapy With Tumor-Treating Fields Plus Temozolomide vs Temozolomide Alone for Glioblastoma: A Randomized Clinical Trial. JAMA. 2015;314(23):2535-2543.

Taphoorn MJB, Dirven L, Kanner AA, et al. Influence of Treatment With Tumor-Treating Fields on Health-Related Quality of Life of Patients With Newly Diagnosed Glioblastoma: A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2018;4(4):495-504.

Provided by DME MACs

Batchelor T, Shih HA, Wen PY. Management of glioblastoma in older adults UpToDate. Waltham, Ma.: UpToDate; 2017. https://www.uptodate.com/contents/management-of-glioblastoma-in-older-adults. Accessed April 23, 2018

Bhandari M, Gandhi AK, Devnani B, Kumar P, Sharma DN, Julka PK. Comparative Study of Adjuvant Temozolomide Six Cycles Versus Extended 12 Cycles in Newly Diagnosed Glioblastoma Multiforme. J Clin Diagn Res. 2017;11(5):XC04-XC08.

Cloughesy TF, Lassman AB. NovoTTF: where to go from here? Neuro Oncol. 2017;19(5):605-608.

Food and Drug Administration. Novocure Submission to Neurological Devices Panel. NovoTTF-100A. March 17, 2011.

Food and Drug Administration. Summary of Safety and Effectiveness Data. PMA P100034. Novocure TTF-100A. April 8, 2011.

Food and Drug Administration. Summary of Safety and Effectiveness Data. PMA P100034/S013. Novocure TTF-100A. October 5, 2015.

Kesari S, Ram Z, Investigators EFT. Tumor-treating fields plus chemotherapy versus chemotherapy alone for glioblastoma at first recurrence: a post hoc analysis of the EF-14 trial. CNS Oncol. 2017;6(3):185-193.

Kirson ED, Dbaly V, Tovarys F, et al. Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors. Proc Natl Acad Sci U S A. 2007;104(24):10152-10157.

Kirson ED, Gurvich Z, Schneiderman R, et al. Disruption of cancer cell replication by alternating electric fields. Cancer Res. 2004;64(9):3288-3295.

Martinez-Garcia M, Alvarez-Linera J, Carrato C, et al. SEOM clinical guidelines for diagnosis and treatment of glioblastoma (2017). Clin Transl Oncol. 2018;20(1):22-28.

Mehta M, Wen P, Nishikawa R, Reardon D, Peters K. Critical review of the addition of tumor treating fields (TTFields) to the existing standard of care for newly diagnosed glioblastoma patients. Crit Rev Oncol Hematol. 2017;111:60-65.

Mittal S, Klinger NV, Michelhaugh SK, Barger GR, Pannullo SC, Juhasz C. Alternating electric tumor treating fields for treatment of glioblastoma: rationale, preclinical, and clinical studies. J Neurosurg. 2018;128(2):414-421.

National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Central Nervous System Cancers. Version 2.2018 November 26, 2018. Accessed January 3, 2019.

Palmer JD, Bhamidipati D, Mehta M, et al. Treatment recommendations for elderly patients with newly diagnosed glioblastoma lack worldwide consensus. J Neurooncol. 2018;140(2):421-426.

Sampson JH. Alternating Electric Fields for the Treatment of Glioblastoma. JAMA. 2015;314(23):2511-2513.

Sulman EP, Ismaila N, Armstrong TS, et al. Radiation Therapy for Glioblastoma: American Society of Clinical Oncology Clinical Practice Guideline Endorsement of the American Society for Radiation Oncology Guideline. J Clin Oncol. 2017;35(3):361-369.

Toms SA, Kim CY, Nicholas G, Ram Z. Increased compliance with tumor treating fields therapy is prognostic for improved survival in the treatment of glioblastoma: a subgroup analysis of the EF-14 phase III trial. J Neurooncol. 2019;141(2):467-473.

Weller M, van den Bent M, Tonn JC, et al. European Association for Neuro-Oncology (EANO) guideline on the diagnosis and treatment of adult astrocytic and oligodendroglial gliomas. Lancet Oncol. 2017;18(6):e315-e329.

Wick W. TTFields: where does all the skepticism come from? Neuro Oncol. 2016;18(3):303-305.

Wick W, Osswald M, Wick A, Winkler F. Treatment of glioblastoma in adults. Ther Adv Neurol Disord. 2018;11:1756286418790452.

Wick W, Platten M. Understanding and Treating Glioblastoma. Neurol Clin. 2018;36(3):485-499.

Provided by CAC Members

Chang E, Patel CB, Pohling C, et al. Tumor treating fields increases membrane permeability in glioblastoma cells. Cell Death Discov. 2018;4:113.

Kim EH, Kim YH, Song HS, et al. Biological effect of an alternating electric field on cell proliferation and synergistic antimitotic effect in combination with ionizing radiation. Oncotarget. 2016;7(38):62267-62279.

Kim EH, Song HS, Yoo SH, Yoon M. Tumor treating fields inhibit glioblastoma cell migration, invasion and angiogenesis. Oncotarget. 2016;7(40):65125-65136.

Revision History Information

Revision History Date	Revision History Number	Revision History Explanation	Reasons for Change
01/01/2020	R8	Revision Effective Date: 01/01/2020 COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY: Revised: “face-to-face” to “in-person”, where applicable Revised: Order information as a result of Final Rule 1713 CODING INFORMATION: Removed: Field titled “Bill Type” Removed: Field titled “Revenue Codes” Removed: Field titled “ICD-10 Codes that Support Medical Necessity” Removed: Field titled “ICD-10 Codes that DO NOT Support Medical Necessity” Removed: Field titled “Additional ICD-10 Information” DOCUMENTATION REQUIREMENTS: Revised: “physician’s” to “ treating practitioner’s” GENERAL DOCUMENTATION REQUIREMENTS: Revised: Prescriptions (orders) to SWO 02/27/2020: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because they are due to non-discretionary coverage updates reflective of CMS FR-1713.	Provider Education/Guidance Other
09/01/2019	R7	Revision Effective Date: 09/01/2019 COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY: Added: Criteria for Initial Coverage for Newly Diagnosed Glioblastoma Multiforme Added: Criteria for Continued Coverage for Newly Diagnosed GBM Beyond the First Three Months of Therapy Added: Coverage statement for Recurrent GBM Added: Coverage statement for Other Uses Added: Beneficiaries Entering Medicare FFS requirements SUMMARY OF EVIDENCE: Added: Summary of evidence reviewed ANALYSIS OF EVIDENCE (RATIONALE FOR DETERMINATION): Added: Background, CAC and key question information, and Conclusion HCPCS CODES: Added: HCPCS Modifiers GA, GZ, KF, and KX SOURCES OF INFORMATION: Added: References to sources of information BIBLIOGRAPHY: Added: Bibliography information RELATED LOCAL COVERAGE DOCUMENTS: Added: Response to Comments: Tumor Treatment Field Therapy (TTFT) – DL34823	Reconsideration Request
01/01/2017	R6	No changes have been made to this LCD. 03/29/2018: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.	Other
01/01/2017	R5	Revision Effective Date: 01/01/2017 COVERAGE INDICATIONS, INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY: Added: New reference language and directions to Standard Documentation Requirements Added: General Requirements DOCUMENTATION REQUIREMENTS: Added: General Documentation Requirements Added: New reference language and directions to Standard Documentation Requirements POLICY SPECIFIC DOCUMENTATION REQUIREMENTS: Added: Direction to Standard Documentation Requirements Removed: PIM reference from Appendices SOURCES OF INFORMATION AND BASIS FOR DECISION: Removed: Sources of Information RELATED LOCAL COVERAGE DOCUMENTS: Added: LCD-related Standard Documentation Requirements article	Provider Education/Guidance
07/01/2016	R4	Revision Effective Date: 07/01/2016 Links for Sources of Information and Basis for Decision updated.	Typographical Error
07/01/2016	R3	Revision Effective Date: 07/01/2016 Links for Sources of Information and Basis for Decision updated.	Typographical Error
07/01/2016	R2	Effective July 1, 2016 oversight for DME MAC LCDs is the responsibility of CGS Administrators, LLC 18003 and 17013 and Noridian Healthcare Solutions, LLC 19003 and 16013. No other changes have been made to the LCDs.	Change in Assigned States or Affiliated Contract Numbers
10/01/2015	R1	Draft promoted to final.	Other (Draft LCD promoted to final.)

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License For Use of National Uniform Billing Committee (NUBC) UB-04

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Subject to the terms and conditions contained in this Agreement, you, your employees, and agents are authorized to use UB-04 Data only as contained in the following authorized materials and solely for internal use by yourself, employees and agents within your organization within the United States and its territories. Use of UB-04 Data is limited to use in programs administered by Centers for Medicare & Medicaid Services (CMS). You agree to take all necessary steps to ensure that your employees and agents abide by the terms of this Agreement. You acknowledge that the AHA holds all copyright, trademark, and other rights in UB-04 Data. You shall not remove, alter, or obscure any AHA copyright notices or other proprietary rights notices included in the materials.
Any use not authorized herein is prohibited, including, by way of illustration and not by way of limitation, making copies of UB-04 Data for resale and/or license, transferring copies of UB-04 Data to any party not bound by this agreement, creating any modified or derivative work of UB-04 Data, or making any commercial use of UB-04 Data. License to use UB-04 Data for any use not authorized herein must be obtained through the American Hospital Association, 155 N. Wacker Drive, Suite 400, Chicago, Illinois, 60606. Applications are available at the NUBC website, http://www.nubc.org/ http://www.nubc.org/.
The UB-04 Data included in this product is commercial technical data and/or computer databases and/or commercial computer software and/or commercial computer software documentation, as applicable, which was developed exclusively at private expense by the American Hospital Association, 155 N. Wacker Drive, Suite 400, Chicago, Illinois 60606. U.S. Government rights to use, modify, reproduce, release, perform, display, or disclose these technical data and/or computer data bases and/or computer software and/or computer software documentation are subject to the limited rights restrictions of DFARS 252.227-7015(b)(2) (November 1995) and/or subject to the restrictions of DFARS 227.7202-1(a) (June 1995) and DFARS 227.7202-3(a) (June 1995), as applicable for U.S. Department of Defense procurements and the limited rights restrictions of FAR 52.227-14 (December 2007) and FAR 52.227-19 (December 2007), as applicable, and any applicable agency FAR Supplements, for non-Department of Defense Federal procurements.
AHA DISCLAIMER OF WARRANTIES AND LIABILITIES. UB-04 Data is provided "as is" without warranty of any kind, either expressed or implied, including but not limited to, the implied warranties of merchantability and fitness for a particular purpose. The sole responsibility for the software, including any UB-04 Data and other content contained therein, is with the Medicare/Medicaid Contractor or the CMS; and no endorsement by the AHA is intended or implied. The AHA expressly disclaims responsibility for any consequences or liability attributable to or related to any use, non-use, or interpretation of information contained or not contained in this file/product. This Agreement will terminate upon notice to you if you violate the terms of this Agreement. The AHA is a third-party beneficiary to this Agreement.
CMS DISCLAIMER. The scope of this license is determined by the AHA, the copyright holder. Any questions pertaining to the license or use of the UB-04 Data should be addressed to the AHA. End users do not act for or on behalf of the CMS. CMS DISCLAIMS RESPONSIBILITY FOR ANY LIABILITY ATTRIBUTABLE TO END USER USE OF THE UB-04 DATA. CMS WILL NOT BE LIABLE FOR ANY CLAIMS ATTRIBUTABLE TO ANY ERRORS, OMISSIONS, OR OTHER INACCURACIES IN THE INFORMATION OR MATERIAL COVERED BY THIS LICENSE. In no event shall CMS be liable for direct, indirect, special, incidental, or consequential damages arising out of the use of such information or material.

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Tumor Treatment Field Therapy (TTFT)

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Page Help for LCD - Tumor Treatment Field Therapy (TTFT) (L34823)

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