Galvanize PEF System 2024 Reimbursement And Coding User Guide

Galvanize PEF System 2024 Reimbursement And Coding User Guide

BACKGROUND

ABOUT ALIYA SYSTEM FOR PULSED FIELD ABLATION OF SOFT TISSUE

The Aliya™ system is designed to ablate soft tissue through the delivery of pulsed electric fields (PEF) energy to target tissue. The high frequency, short duration energy is delivered to the target tissue to induce cell death while maintaining the extracellular matrix.

INDICATIONS FOR USE

The Aliya system is 510(k) cleared in the United States for the surgical ablation of soft tissue.

DISCLAIMER

Galvanize Therapeutics does not promote the off-label use of its products and nothing herein is intended to promote an off-label use of the Aliya System. The Aliya System is a tool for the surgical ablation of soft tissues, and is not intended to treat, cure, prevent or mitigate any specific disease or condition.
The information provided contains general reimbursement information and is presented for illustrative purposes. The information does not constitute reimbursement or legal advice. It is the provider’s sole responsibility to determine medical necessity, the proper site for delivery of any services, and to submit accurate and appropriate codes, charges and modifiers based on the services rendered and the patient’s medical condition.
It is also the provider‘s sole responsibility to understand and comply with Medicare national coverage determinations (NCD), Medicare local coverage determinations (LCD), and any other specific payer billing requirements established by relevant payers. Payer billing, coding and coverage requirements vary from payer to payer, may be updated frequently, and should be verified before treatment for limitations on diagnosis, coding, or service requirements. Galvanize Therapeutics recommends you consult with payers, reimbursement specialists, and/or legal counsel regarding all coding, coverage, and reimbursement matters. All coding and
billing submissions to the federal government and any other payer must be truthful and not misleading, and require full disclosure for the reimbursement of any service or procedure. Galvanize Therapeutics specifically disclaims any responsibility for actions or consequences resulting from the use of this information.

CPT® Copyright 2024 American Medical Association. All rights reserved CPT® is a trademark of the American
Medical Association. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT®, and the AMA is not necessarily recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. All trademarks are the property of their respective owners.

DISCLOSURE

Prior to using the Aliya System, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions and potential adverse events. For full prescribing information, please visit www.galvanizetherapeutics.com.

PHYSICIAN, HOSPITAL OUTPATIENT, AND ASC CODING

Medicare 2024 National Average Payment (Not Adjusted Geographically)

Service Provided| Physician Fee Schedule1|   ASC2Payment/Indicator| Hospital3
CPT®|  Description| Non-Facility (OBL)| Facility (-26)| APC/Indicator APC/ Indicator| OPPSPayment
0600T*| Ablation, irreversible electroporation; 1 or more tumors per organ, including imaging guidance, when performed, percutaneous (Do not report 0600T in conjunction with 76940, 77002, 77013, 77022)| No national payment established| $ 6604| J8| 5362| *** J1| $9808
0601T| Ablation, irreversible electroporation; 1 or more tumors, including fluoroscopic and ultrasound guidance, when performed, open (Do not report 0601T in conjunction with 76940, 77002)| No national payment established| $ 6 4 81| J8| 5362| J1| $9808

*2024 CPT® Professional. Current Procedural Terminology (CPT®) is copyright 1966, 1970, 1973, 1977, 1981, 1983-2022 by the American Medical Association. All rights reserved. CPT® is a registered trademark of the American Medical Association (AMA).

CATEGORY III CPT® CODES

The Aliya PEF procedure may be reported using the Category III CPT® codes in the table above. These codes
specifically describe irreversible electroporation of tumors via a percutaneous or open approach. If any
other type of laproscopic, endoscopic, or bronchoscopic approach is performed an unlisted procedure code
may be reported. Unlisted CPT® codes or “not otherwise specified” CPT® codes allow physicians to report
procedures that do not have a more specific CPT® code. Reporting an unlisted code correctly with appropriate
documentation allows physicians and hospitals to submit coding for a procedure that does not have a specific
CPT® code. The procedures described by CPT® 0600T and 0601T include the imaging guidance procedures. Imaging guidance CPT® codes are not separately submitted on the CMS Form 1500 claim form.

Category III CPT® Codes are temporary codes for emerging technology, services and procedures that allow
for specific data collection associated with those services and procedures. According to the AMA CPT®, if a Category III code is available, it must be reported instead of a Category I unlisted code1 .
There are no assigned RVU’s or established physician payment for these Category III CPT® codes.
Reimbursement to the physician is at the payer’s discretion. Payers may request documentation of clinical efficacy to support coverage. Payers that have implemented the new Category III IRE codes may request documentation of clinical efficacy to support coverage. The following items are recommended to support your claim submissions:

• Copy of operative report
• Letter of medical necessity
• Copy of the FDA clearance letter

When submitting a Category III CPT® code, it is recommended that providers submit a narrative listing a Category I CPT® code that they feel is comparable in time, effort, complexity, and value to the service provided, suggesting that the payer value the service represented by the Category III CPT® code based on the value assigned to this comparable Category I CPT® code. It will be important to document the services provided in terms of resources and time for appropriate payment consideration for the professional component of the procedure.

THE CODES BELOW DO NOT PRESUME, ASSUME, OR INTEND TO PROMOTE THE USE OF THIS GENERAL TOOL IN ANY SPECIFIC ANATOMICAL LOCATION OR FOR ANY SPECIFIC TREAMENT BY THE HEALTHCARE PROVIDER. THIS REIMBURSEMENT GUIDE IS ONLY INTENDED TO IDENTIFY GENERAL SOFT TISSUE LOCATIONS.

KIDNEY ICD-10-PCS CODES AND MS-DRGS

ICD-10-PCS Codes (OCT 1, 2023 to SEPT 30, 2024)

The listed ICD-10-PCS codes are examples of codes that may apply for kidney ablation procedures.4 Each ICD-10-PCS may be grouped under a Medicare Severity-Diagnosis Related Group (MS-DRGs).5

661
0T510ZZ| Destruction of left kidney, open approach| 656 – 661
0T513ZZ| Destruction of left kidney, percutaneous approach| 656 – 661
0T514ZZ| Destruction of left kidney, percutaneous endoscopic approach| 656 – 661
0T530ZZ| Destruction of right kidney pelvis, open approach| 656 – 661
0T533ZZ| Destruction of right kidney pelvis, percutaneous approach| 656 – 661
0T534ZZ| Destruction of right kidney pelvis, percutaneous endoscopic approach| 656 – 661
0T540ZZ| Destruction of left kidney pelvis, open approach| 656 – 661
0T543ZZ| Destruction of left kidney pelvis, percutaneous approach| 656 – 661
0T544ZZ| Destruction of left kidney pelvis, percutaneous endoscopic approach| 656 – 661

Medicare Severity-Diagnosis Related Groups (MS-DRGs)5,6 (OCT 1, 2023 to SEPT 30, 2024)
The following MS-DRGs may apply to kidney ablation procedures for Medicare patients. Other secondary diagnosis codes corresponding to additional conditions at the time of admission or developing subsequently, and having an effect on the procedures performed or length of stay during the same inpatient admission, may also be reported.

MS-DRG 5| MS-DRG Description| Relative Weight Hospital Payment
---|---|---
656| KIDNEY & URETER PROCEDURES FOR NEOPLASM W/ MCC| 3 . 1 3 76| $21,968
657| KIDNEY & URETER PROCEDURES FOR NEOPLASM W/ CC| 1 . 8 4 42| $ 12 ,9 12
658| KIDNEY & URETER PROCEDURES FOR NEOPLASM W/O CC/MCC| 1 . 4 8 04| $10,365
659| KIDNEY & URETER PROCEDURES FOR NON-NEOPLASM W/ MCC| 2 . 58 89| $ 1 8 ,126
660| KIDNEY & URETER PROCEDURES FOR NON-NEOPLASM W/ CC| 1 . 3 4 59| $ 9 , 4 2 3
661| KIDNEY & URETER PROCEDURES FOR NON-NEOPLASM W/O CC/MCC| 1 .0 4 8 4| $ 7, 3 4 0

ICD-10-CM7 Diagnosis Codes (OCT 1, 2023 to SEPT 30, 2024)
The listed ICD-10-CM diagnosis codes are examples of codes that may apply for kidney ablation procedures.

LIVER ICD-10-PCS CODES AND MS-DRGS

ICD-10-PCS Codes (OCT 1, 2023 to SEPT 30, 2024)
The listed ICD-10-PCS codes are examples of codes that may apply for liver ablation procedures.4 Each ICD-10-PCS may be grouped under a Medicare Severity-Diagnosis Related Group (MS-DRGs).5

Medicare Severity-Diagnosis Related Groups (MS-DRGs)5,6 (OCT 1, 2023 to SEPT 30, 2024)
The following MS-DRGs may apply to liver ablation procedures for Medicare patients. Other secondary diagnosis codes corresponding to additional conditions at the time of admission or developing subsequently, and having an effect on the procedures performed or length of stay during the same inpatient admission, may also be reported.

MS-DRG 5| MS-DRG Description| Relative Weight Hospital Payment
---|---|---
356| OTHER DIGESTIVE SYSTEM O.R. PROCEDURES W/ MCC| 4 . 2787| $29,958
357| OTHER DIGESTIVE SYSTEM O.R. PROCEDURES W/ CC| 2 .1 9 6 8| $ 15 , 381
358| OTHER DIGESTIVE SYSTEM O.R. PROCEDURES W/O CC/MCC| 1 . 28 1 1| $ 8 , 9 7 0
405| PANCREAS, LIVER & SHUNT PROCEDURES W/ MCC| 5 . 5052| $38,545
406| PANCREAS, LIVER & SHUNT PROCEDURES W/ CC| 2 . 8 874| $20, 216
407| PANCREAS, LIVER & SHUNT PROCEDURES W/O CC/MCC| 2 . 1 5 1 0| $15,060

ICD-10-CM7 Diagnosis Codes (OCT 1, 2023 to SEPT 30, 2024)
The listed ICD-10-CM diagnosis codes are examples of codes that may apply for liver ablation procedures.

LUNG ICD-10-PCS CODES AND MS-DRGS

ICD-10-PCS Codes (OCT 1, 2023 to SEPT 30, 2024)
The listed ICD-10-PCS codes are examples of codes that may apply for lung ablation procedures.4 0Each ICD-10-PCS may be grouped under a Medicare Severity-Diagnosis Related Group (MS-DRGs).5

– 165
0B553ZZ| Destruction of Right Middle Lobe Bronchus, Percutaneous Approach| 163 – 165
0B563ZZ| Destruction of Right Lower Lobe Bronchus, Percutaneous Approach| 163 – 165
0B573ZZ| Destruction of Left Main Bronchus, Percutaneous Approach| 163 – 165
0B583ZZ| Destruction of Left Upper Lobe Bronchus, Percutaneous Approach| 163 – 165
0B593ZZ| Destruction of Lingula Bronchus, Percutaneous Approach| 163 – 165
0B5B3ZZ| Destruction of Left Lower Lobe Bronchus, Percutaneous Approach| 163 – 165
0B5C3ZZ| Destruction of Right Upper Lung Lobe, Percutaneous Approach| 166 – 168
0B5D3ZZ| Destruction of Right Middle Lung Lobe, Percutaneous Approach| 166 – 168
0B5F3ZZ| Destruction of Right Lower Lung Lobe, Percutaneous Approach| 166 – 168
0B5G3ZZ| Destruction of Left Upper Lung Lobe, Percutaneous Approach| 166 – 168
0B5H3ZZ| Destruction of Lung Lingula, Percutaneous Approach| 166 – 168
0B5J3ZZ| Destruction of Left Lower Lung Lobe, Percutaneous Approach| 166 – 168
0B5K3ZZ| Destruction of Right Lung, Percutaneous Approach| 166 – 168
0B5L3ZZ| Destruction of Left Lung, Percutaneous Approach| 166 – 168
0B5M3ZZ| Destruction of Bilateral Lungs, Percutaneous Approach| 166 – 168
0B5N3ZZ| Destruction of Right Pleura, Percutaneous Approach| 163 – 165
0B5P3ZZ| Destruction of Left Pleura, Percutaneous Approach| 163 – 165
0B5T3ZZ| Destruction of Diaphragm, Percutaneous Approach| 163 – 165
0B5_0ZZ| Destruction of [see above], Open Approach| 163 – 165

Medicare Severity-Diagnosis Related Groups (MS-DRGs)5,6 (OCT 1, 2023 to SEPT 30, 2024)
The following MS-DRGs may apply to lung ablation procedures for Medicare patients. Other secondary diagnosis codes corresponding to additional conditions at the time of admission or developing subsequently, and having an effect on the procedures performed or length of stay during the same inpatient admission, may also be reported.

MS-DRG 3| MS-DRG Description| Relative Weight Hospital Payment
---|---|---
163| MAJOR CHEST PROCEDURES W/ MCC| 4 . 7 13 6| $33,003
164| MAJOR CHEST PROCEDURES W/ CC| 2.5504| $1 7, 85 7
165| MAJOR CHEST PROCEDURES W/O CC/MCC| 1.8 76 4| $ 13 , 13 8
166| OTHER RESP SYSTEM O.R. PROCEDURES W/MCC| 4.0578| $ 2 8 , 41 1
167| OTHER RESP SYSTEM O.R. PROCEDURES W/ CC| 1 . 8198| $ 12 , 742
168| OTHER RESP SYSTEM O.R. PROCEDURES W/O CC/MCC| 1 . 35 5 7| $ 94 9 2

ICD-10-CM7Diagnosis Codes (OCT 1, 2023 to SEPT 30, 2024)
The listed ICD-10-CM diagnosis codes are examples of codes that may apply for lung ablation procedures.

PANCREAS ICD-10-PCS CODES AND MS-DRGS

ICD-10-PCS Codes (OCT 1, 2023 to SEPT 30, 2024)
The listed ICD-10-PCS codes are examples of codes that may apply for pancreas ablation procedures.4 Each ICD-10-PCS may be grouped under a Medicare Severity-Diagnosis Related Group (MS-DRGs).5

Medicare Severity-Diagnosis Related Groups (MS-DRGs)5,6 (OCT 1, 2023 to SEPT 30, 2024)
The following MS-DRGs may apply to pancreas ablation procedures for Medicare patients. Other secondary 0diagnosis codes corresponding to additional conditions at the time of admission or developing subsequently, and having an effect on the procedures performed or length of stay during the same inpatient admission, may also be reported.

MS-DRG 3| MS-DRG Description| Relative Weight Hospital Payment
---|---|---
405| PANCREAS, LIVER, & SHUNT PROCEDURES W/ MCC| 5 . 5052| $38,545
406| PANCREAS, LIVER, & SHUNT PROCEDURES W/ CC| 2 . 8 874| $20,216
407| PANCREAS, LIVER, & SHUNT PROCEDURES W/O CC/MCC| 2 . 1 5 1 0| $15,060
628| OTHER ENDOCRINE, NUTRIT & METAB O.R. PROC W/ MCC| 4 .01 4 5| $28,108
629| OTHER ENDOCRINE, NUTRIT & METAB O.R. PROC W/ CC| 2 . 2628| $15,843
630| OTHER ENDOCRINE, NUTRIT & METAB O.R. PROC W/O CC/MCC| 1 . 39 6 3| $ 9, 7 7 6

ICD-10-CM7Diagnosis Codes (OCT 1, 2023 to SEPT 30, 2024)
The listed ICD-10-CM diagnosis codes are examples of codes that may apply for pancreas ablation procedures.

REIMBURSEMENT SUPPORT

For questions regarding coding, coverage, payment and other reimbursement information, please contacts us at: AliyaReimbursement@galvanizetx.com.

REIMBURSEMENT TERMINOLOGY

packaged with the primary “J1” service for the claim, except services with OPPS status indicator of “F,” “G,” “H,” “L” and “U”; ambulance services; diagnostic and screening mammography; rehabilitation therapy services; services assigned to a new technology APC; self- administered drugs; all preventive services; and certain Part B inpatient services.
J8| Device-intensive procedure; paid at adjusted rate
ICD-10-CM| International Classification of Diseases, 10th Revision, Clinical Modification
ICD-10-PCS| International Classification of Diseases, 10th Revision, Procedure Coding System
IPPS| Inpatient Prospective Payment System
MS-DRG| Medicare Severity Diagnosis Related Group
W/MCC| Major Complications and Comorbidities
W/CC| With Complications and Comorbidities
W/O CC/MCC| Without Complications or Comorbidities, and Without Major Complications and Comorbidities.
Relative Weight| A numeric value that reflects the relative resource consumption for the DRG to which it is assigned

SOURCES

1. CMS Physician Fee Schedule. CMS-1784-F. https://www.cms.gov/medicare/medicare-fee-service payment/physicianfeesched/ puffs-federal-regulation-notices/cms-1784-f

2. CMS ASC Payment. CMS-1786-FC ASC. https://www.cms.gov/medicare/payment/prospective-payment systems/ambulatory surgical-center-ask/ask-regulations-and/cms-1786-fc

3. CMS OPPS Payment. CMS-1786-FC. https://www.cms.gov/medicare/payment/prospective-payment systems/hospitaloutpatient/regulations-notices/cms-1786-fc

4. CMS, 2024 ICD-10 Procedure Coding System (ICD-10-PCS). https://www.cms.gov/medicare/coding billing/icd-10-codes/2024- icd-10-pcs

5. CMS, 2024 ICD-10-CM/PCS MS-DRG v41, Definitions Manual. https://www.cms.gov/icd10m/FY2024 nprmversion41.0-fullcodecms/fullcode_cms/P0001.html

6. CMS, [CMS-1785-F] 2024 Medicare Hospital Inpatient Prospective Payment System (IPPS) Final Rule; Federal Register.
   https://www.govinfo.gov/content/pkg/FR-2023-08-28/pdf/2023-16252.pdf. Payment is calculated based on the national adjusted standardized amount $7,001.60. Actual Medicare payment rates will vary from adjustments by Wage Index and Geographic Adjustment Factor depending on geographic locality. Also note that any applicable coinsurance, deductible, and other amounts that are patient obligations are included in the payment amount shown.

7. Centers for Disease Control and Prevention (CDC), National Center for Health Statistics (NCHS). International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM). https://www.cdc.gov/nchs/icd/icd-10 cm.htm. Updated June 29, 2023.

CAUTION: Federal (US) law restricts this device to sale by or on the order of a physician. Important information: Prior to use, refer to the Instructions for Use that are supplied with this device for indications, contraindications, side effects, suggested procedure, warnings and precautions. Galvanize and Aliya are trademarks and may be registered in the US and/or in other countries.
All rights reserved.
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References

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