Billing and Coding: Proton Beam Therapy

This article gives guidance for billing, coding, and other guidelines in relation to local coverage policy L36658-Proton Beam Therapy.

Documentation Requirements

• All documentation must be maintained in the patient’s medical record and available to the contractor upon request.
• Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service(s)). The record must include the physician or non-physician practitioner responsible for and providing the care of the patient.
• The submitted medical record should support the use of the selected diagnosis code(s). The submitted CPT/HCPCS code should describe the service performed.
• Each claim must be submitted with diagnosis codes that reflect the condition of the patient, and indicate the reason(s) for which the service was performed. Claims submitted without diagnosis codes will be returned.
• Documentation in the patient medical record must support the reasonable and necessary requirements as outlined under the Coverage Indication, Limitations, and/or Medical Necessity section of this LCD.
• Documentation must include the planned course of therapy, type and delivery of treatment, level of clinical management involved and ongoing documentation of any changes in the course of treatment, and DHV as noted in the covered indications section.

Coding
1. The proton delivery codes are technical component only codes and can only be billed by the facility delivering the treatment.
2. Selection of the correct code is based on the complexity and compensation of the treatment.
Simple - Proton treatment delivery to a single treatment area utilizing a single nontangential/oblique port, custom block with compensation (CPT 77522) and without
compensation (CPT 77520).
Intermediate - Proton treatment delivery to one or more treatment areas utilizing two or more ports or one or more tangential/oblique ports with custom blocks and compensators (CPT 77523).
Complex - Proton treatment delivery to one or more treatment areas utilizing two or more ports per treatment area with matching or patching fields and/or multiple isocenters, with custom blocks and compensators (CPT 77524).

3. The physician work is billed under treatment planning and treatment management codes.

4. CMS Pub 100-04 Medicare Claims Processing Manual, Chapter 32 – Billing Requirements for Special Services, Section 69.6 – Requirements for Billing Routine Costs of Clinical Trials.
Routine Costs Submitted by Practitioners/Suppliers:
Services furnished to Medicare beneficiaries, who are control group volunteers participating in qualifying clinical trials, are to be coded/billed in the following manner:
Effective for claims with dates of service on or after January 1, 2014 it is mandatory to report a clinical trial number on claims for items/services provided in clinical trials/studies/registries, or under CED. Provides report the 8-digit number on the following claims locators:

• CMS-1500 paper form-place in Field 19 (preceded by ‘CT’);or
• 837 P—Loop 2300, REF02, REF01-P4 (do not use “CT’ on the electronic claim).

In addition to the clinical trial number, claims should include:

• Diagnosis code Z00.6 (in either the primary/secondary positions)
• HCPCS modifier Q0 or Q1 as appropriate

5. The associated IDE/NCT numbers MUST be included on each claim. The below applies to both Institutional and Professional claims:

• The 7-digit alpha numeric IDE number should be placed in REF02 (REF01=LX)
• 8 Digit NCT Registry Number must be on the claim as follows:
• For institutional claims that are submitted on the electronic claim 837I, the 8-digit number should be placed in Loop 2300 REF02 (REF01=P4) when a clinical trial claim includes:
  • Condition code 30; ICD-9 code of V70.7/ICD-10 code Z00.6 (in either the primary or secondary positions) and
  • Modifier Q0 and/or Q1, as appropriate (outpatient claims only).
• For professional claims:
  
  • For electronic claims the 8-digit clinical trial number is listed as; the electronic equivalent 837P in Loop 2300 REF02(REF01=P4) (do not use CT on the electronic claim, e.g., 12345678)
  • The 8-digit clinical trial number preceded by the 2 alpha characters of CT (use CT only on paper claims) must be placed in Field 19 of the paper claim Form CMS-1500 (e.g., CT12345678) or when a clinical trial claim includes: 
• ICD-9 code of V70.7/ICD-10 code Z00.6 (in either the primary or secondary positions) and Modifier Q0 and/or Q1, as appropriate (outpatient claims only)

Routine Costs Submitted by Institutional Providers:
Services furnished to Medicare beneficiaries, who are control group volunteers participating in qualifying diagnostic clinical trials, are to be coded/billed in the following manner:

All Institutional Clinical Trial Claims

Effective for claims with dates of service on or after January 1, 2014, it is mandatory to report a clinical trial number on claims for items/services provided in clinical trials/studies/registries, or under CED. Institutional claims submitted without a clinical trial number shall be returned to providers.

NOTE: The Q1 modifier is line item specific and must be used to identify items and services that constitute medically necessary routine patient care or treatment of complications arising from a Medicare beneficiary’s participation in a Medicare –covered clinical trial. Items and services that are provided solely to satisfy data collection and analysis needs and that are not used in the clinical management of the patient are not covered and may not be billed using the Q1 modifier. Items and services that are not covered by Medicare by virtue of a statutory exclusion or lack of a benefit category also may not be billed using the Q1 modifier. When billed in conjunction with the Z00.6 diagnosis code, the Q1 modifier will serve as the providers’ attestation that the service meets the Medicare coverage criteria (i.e., was furnished to a beneficiary who is participating in a Medicare qualifying clinical trial and represents routine patient care, including complications associated with qualifying trial participation).

Inpatient Clinical Trial Claims

Institutional providers billing clinical trial service(s) must report diagnosis code Z00.6 in either the primary or secondary position and a condition code 30 regardless of whether all services are related to the clinical trial or not.
NOTE: HCPCS codes are not reported on inpatient claims. Therefore, the HCPCS modifier requirements (i.e., Q0/Q1) as outlined in the outpatient clinical trial section immediately below, are not applicable to inpatient clinical trial claims.

Outpatient Clinical Trial Claims

On all outpatient clinical trial claims, providers need to do the following:

• Report condition code 30,
• Report Diagnosis code Z00.6, if ICD-10-CM is applicable, in the primary or secondary position: and
• Identify all lines that contain an investigational item/service with a HCPCS modifier of: Q0 for dates of service on or after 1/1/08
• Identify all lines that contain a routine service with a HCPCS modifier of:Q1 for dates of service on or after 1/1/08.

If the patient cannot clearly meet the criteria for coverage but desires Proton beam radiotherapy based on a marketed theoretical advantage, an ABN should be signed and the claim should be billed with the GA modifier appended to the treatment delivery code. The patient is then liable for payment of the procedure.

Definitions:
Q0 - Investigational clinical service provided in a clinical research study that is in an approved clinical research study. Investigational clinical services are defined as those items and services that are being investigated as an objective within the study. Investigational clinical services may include items or services that are approved, unapproved, or otherwise covered (or not covered) under Medicare.
Q1 - Routine clinical service provided in a clinical research study that is in an approved clinical research study. Q1 replaces QV. Routine clinical services are defined as those items and services that are covered for Medicare beneficiaries outside of the clinical research study; are used for the direct patient management within the study; and, do not meet the definition of investigational clinical services. Routine clinical services may include items or services required solely for the provision of the investigational clinical services (e.g.,
administration of a chemotherapeutic agent); clinically appropriate monitoring, whether or not required by the investigational clinical service (e.g., blood tests to
measure tumor markers); and items or services required for the prevention, diagnosis, or treatment of research related adverse events (e.g., blood levels of various
parameters to measure kidney function).
GA – Item or service is expected to be denied as not reasonable and necessary.

General Guidelines for Claims submitted to Part A or Part B MAC:

Procedure codes may be subject to National Correct Coding Initiative (NCCI) edits or OPPS packaging edits. Refer to NCCI and OPPS requirements prior to billing Medicare. For services requiring a referring/ordering physician, the name and NPI of the referring/ordering physician must be reported on the claim. A claim submitted without a valid ICD-10-CM diagnosis code will be returned to the provider as an incomplete claim under Section 1833(e) of the Social Security Act. The diagnosis code(s) must best describe the patient's condition for which the service was performed. For diagnostic tests, report the result of the test if known; otherwise the symptoms prompting the performance of the test should be reported.

Advance Beneficiary Notice of Non-coverage (ABN) Modifier Guidelines

An ABN may be used for services which are likely to be non-covered, whether for medical necessity or for other reasons. Refer to CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 30, for complete instructions.

Effective from April 1, 2010, non-covered services should be billed with modifier –GA, -GX, -GY, or –GZ, as appropriate.

The –GA modifier (“Waiver of Liability Statement Issued as Required by Payer Policy”) should be used when physicians, practitioners, or suppliers want to indicate that they anticipate that Medicare will deny a specific service as not reasonable and necessary and they do have an ABN signed by the beneficiary on file. Modifier GA applies only when services will be denied under reasonable and necessary provisions, sections 1862(a)(1), 1862(a)(9), 1879(e), or 1879(g) of the Social Security Act. Effective April 1, 2010, Part A MAC systems will automatically deny services billed with modifier GA. An ABN, Form CMS-R-131, should be signed by the beneficiary to indicate that ‎he/she accepts responsibility for payment.‎ The -GA modifier may also be used on assigned claims when a patient refuses to sign the ABN and the latter is properly witnessed. For claims submitted to the Part A MAC, occurrence code 32 and the date of the ABN is required.

Modifier GX (“Notice of Liability Issued, Voluntary Under Payer Policy”) should be used when the beneficiary has signed an ABN, and a denial is anticipated based on provisions other than medical necessity, such as statutory exclusions of coverage or technical issues. An ABN is not required for these denials, but if non-covered services are reported with modifier GX, will automatically be denied services.

The –GZ modifier should be used when physicians, practitioners, or suppliers want to indicate that they expect that Medicare will deny an item or service as not reasonable and necessary and they have not had an ABN signed by the beneficiary. ‎If the service is statutorily non-covered, or without a benefit category, submit the ‎appropriate CPT/HCPCS code with the -GY modifier. An ABN is not required for these denials, and the limitation of liability does not apply for beneficiaries. Services with modifier GY will automatically deny.