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.