MNB-99-7 September 1999

New York State Medicare Local Medical Review Policy

POLICY NUMBER: RD001E00

DESCRIPTION:
This policy describes mammography, magnetic resonance imaging of the breast, ultrasonic evaluation of the breast, and ductography.

Screening mammography (76092) is a radiological procedure furnished to a woman without signs or symptoms of breast disease, for the purpose of early detection of breast cancer and includes a physician’s interpretation of the results. It is inherently bilateral. The minimum requirements of a screening mammogram are cranio-caudal (CC) and medio-lateral oblique (MLO) views.

Diagnostic mammography (76090, 76091) is the specific evaluation of a patient with signs or symptoms of a breast disorder, or with screening-detected abnormalities. The goal of this radiographic evaluation is to arrive at precise management decisions, such as sonography, magnetic resonance imaging (MRI), biopsy, etc. Diagnostic mammography is to be distinguished from screening mammography in that the latter is done on patients who are asymptomatic. The minimum requirements for a diagnostic mammogram are cranio-caudal (CC) and medio-lateral oblique (MLO) views. Additional views may be required, but are considered part of the complete diagnostic examination.

The components of a screening mammogram include the radiographic test (the mammogram itself), interpretation and report, and the communication of the results to the patient.

The components of a diagnostic mammogram include a brief history (reason for the exam), palpation of the breasts, the radiographic test (the mammogram itself), interpretation and report, and the communication of the results to the patient.

Breast sonography (76645) is the ultrasonic evaluation of an abnormal breast lesion.

Breast MRI (76093, 76094) is the application of magnetic resonance principles to breast imaging.

Ductography (galactography) (76086, 76088) is a contrast enhanced visualization of the breast ducts.

POLICY TYPE:
Local medical necessity policy
An operational statement of national coverage policy
Local coding instructions

CPT/HCPCS SECTION BENEFIT CATEGORY:
Radiology

CPT/HCPCS CODES: ã

   © CPT codes and descriptions only are copyright 1998 American Medical Association (or such other date publication of CPT).

Revenue Codes (Part A only):
400     Imaging Services
409     Other Imaging Services
614     MRI Other

HCFA’S NATIONAL POLICY:

• Title XVIII of the Social Security Act, Section 1862(a)(7)
  This section excludes routine physical checkups.
• Title XVIII of the Social Security Act, Section 1862(a)(1)(A)
  This section states that no Medicare payment shall be made for items or services that are not  reasonable and necessary for the diagnosis or treatment of illness or injury.
• Title XVIII of the Social Security Act, Section 1833(e)
  This section prohibits Medicare payment for any claim that lacks the necessary information to process the claim.
• 21 CFR part 900, subpart B
  This section specifies FDA certification requirements for suppliers of mammography services.
• Balanced Budget Act of 1997, Section 4101
  This section provides coverage for annual screening mammograms for all women age 40 and over and waives the Part B deductible for screening mammography.
• Medicare Carriers Manual, Section 4601
  This section outlines coverage of screening mammography and special billing instructions when radiologist interpretation results in additional films.
• Medicare Carriers Manual, Section 5266
  This section addresses the payment of screening mammography.
• Medicare Carriers Manual, section 5113
  This section provides rules for physicians’ billings for diagnostic tests.
• Medicare Coverage Issues Manual,Section 50-7
  This section outlines coverage of ultrasound diagnostic procedures.
• Medicare Carriers Manual, Section 4131
  This section outlines coverage of transportation costs in connection with the furnishing of diagnostic tests.
• 42CFR 410.32
  This section of the Code of Federal Regulations presents the conditions supporting diagnostic testing.

INDICATIONS AND LIMITATIONS OF COVERAGE AND/OR MEDICAL NECESSITY:
Screening Mammography
For dates of service on and after January 1, 1998, Medicare covers annual screening mammography for all women age 40 and over, and one baseline screening mammography for women between the ages of 35-39. As of this date, screening mammography is no longer subject to the Part B deductible, however, coinsurance does apply. Diagnostic mammograms are still subject to the deductible.

Medicare Part B covers screening mammography services if they are furnished by a supplier that meets the certification requirements of section 354 of the PHS Act, as implemented by 21 CFR part 900, subpart B. As of October 1, 1994, the Mammography Quality Standards Act requires that all mammography centers that bill Medicare be certified by the Food and Drug Administration (FDA). Medicare will only reimburse FDA-certified mammography centers. A physician’s referral is not required for a screening mammography.

A screening mammogram may detect a radiographic abnormality, prompting the interpreting radiologist to order additional views on the same day. When this is the case, the mammography is no longer considered to be a screening exam and should be reported as a diagnostic mammogram (see coding guideline # 3 for instructions on the appropriate billing of these services). Radiologists who order additional views (diagnostic mammogram) must refer to the treating physician or qualified non-physician practitioner for his/her UPIN and report the condition of the patient back to the treating physician. If there is no treating/referring physician, the radiologist must report the exam results directly to the patient. The cost for additional views is included in the cost of the diagnostic mammography service.

The following limitations apply:

1. The service must be, at a minimum, a two-view exposure (cranio-caudal and a medial-lateral oblique view) of each breast.

2. Payment may not be made for screening mammography performed on a woman under age 35.

3. Payment may only be made for a screening mammography when performed after at least 11 months have passed following the month in which the last screening mammography service was rendered.

4. Mammography facilities that perform screening mammography services may not release screening mammography x-rays for interpretation to physicians who are not approved under the facilities certification number unless:

5. • The patient has requested a transfer of the films from one facility to another for a second opinion, or
   • The patient has moved to another part of the country where the next screening mammography will be performed.

Diagnostic Mammography
Diagnostic mammography is indicated when:

• there are signs or symptoms suggestive of malignancy (e.g., mass, some types of spontaneous nipple discharge, skin changes, unilateral breast pain, or unilateral axillary lymph nodes);
• there are radiographic abnormalities detected on screening mammography;
• there is short interval follow-up(at six month intervals, for 2 years) necessary for unresolved clinical/radiographic concerns; or
• follow-up of an established history of a breast malignancy (primary or secondary) is necessary.

Diagnostic breast evaluation may be indicated in cases of a personal history of malignancy and in cases of benign biopsy-proven breast disease. Once clinical stability has been established, the routine use of diagnostic mammography over screening mammography is not warranted.

A breast implant does not imply that a mammogram is diagnostic in nature. Although additional views may be needed, a screening mammogram should be billed unless there are specific findings that require investigation (see "converting screening mammogram to diagnostic mammogram" in previous paragraph).

Medicare Part B covers diagnostic mammography services if they are furnished by a facility that meets the certification requirements of section 354 of the PHS Act, as implemented by 21 CFR part 900, subpart B. As of October 1, 1994, the Mammography Quality Standards Act requires that all mammography centers that bill Medicare be certified by the Food and Drug Administration (FDA). Medicare will only reimburse FDA-certified mammography centers.

A treating provider (physician or qualified non-physician practitioner) referral is required for diagnostic mammography. The referral should specify the diagnosis prompting the request for a diagnostic mammogram. When a screening mammogram is converted to a diagnostic mammogram, a note in the radiologist’s report will fulfill this provision. Please note other coding requirements for this situation described elsewhere.

Diagnostic mammography must be performed under the direct, on-site supervision of an interpreting physician qualified in mammography.

Breast Sonography
Breast ultrasonography should not routinely be used along with diagnostic mammography. Ultrasonography may be indicated in addition to diagnostic mammography for the evaluation of some ambiguous mammographic or palpable masses or focal asymmetric densities that may represent or mask a mass.

A treating provider (physician or qualified non-physician practitioner) referral is required for breast ultrasound.

Breast sonography should be performed under the general supervision of a physician qualified in breast ultrasonography.

Breast MRI
Breast MRI studies are to be used very selectively. The modality should be restricted to:

• cases where diagnosis is inconclusive, even after standard work-up;
• evaluation of the post-operative patient when scar tissue cannot be differentiated from tumors;
• patients with positive axillary nodes but no known primary;
• patients with rupture of a breast implant; or
• determination of the extent of disease in patients with known malignancy, prior to treatment (to assure confinement to one segment of the breast).

Breast MRI should be performed under the general supervision of a physician qualified in magnetic resonance imaging.

A treating provider (physician or qualified non-physician practitioner) referral is required for breast MRI.

Ductogram (Galactogram)
Ductography is useful as an aid in diagnosing the cause of an abnormal nipple discharge and is valuable in diagnosing intraductal papillomas.

Ductography should be performed under the personal supervision of a physician qualified in ductography.

A treating provider (physician or qualified non-physician practitioner) referral is required for ductography.

General Limitations:
A diagnostic mammogram, a breast sonogram, or a breast MRI for a diagnosis of neoplasm of unspecified nature of bone, soft tissue and skin (239.2), is acceptable only when related to the breast (i.e., metastasis).

An evaluation and management (E&M) service (e.g., 99201-99275) should not be coded in addition to the mammogram on the same date or on a subsequent date, by a provider whose sole responsibility is the performance of the mammogram (e.g., a radiologist).

A physician such as an obstetrician, gynecologist, or breast surgeon may perform an E&M service in addition to the mammogram if there are separately identifiable services rendered other than the components of the mammogram.

For Part B only: Global, technical and/or professional screening mammography, diagnostic mammography, breast sonography, breast MRI and ductography services are payable in office (11) and certified mobile unit (99). In addition, the professional component is payable in places of service inpatient hospital (21), outpatient hospital (22), and emergency room (23).

Global billing (i.e., for the combined professional and technical services) for diagnostic tests is allowed only when the billing physician personally performed or supervised the test, and then only when both the technical and professional components are done in the same facility (location). The service should not be billed globally when the physician purchases the test from an outside supplier. When diagnostic tests are purchased, the physician must identify the supplier by name and address, provide the supplier’s provider number and provide the supplier’s charge for the test.

Transportation costs are associated with mobile units for diagnostic mammography tests only. There is no separate transportation cost allowed for screening mammography, or other breast imaging procedures. To receive transportation payments, the approved portable x-ray supplier must also meet the certification requirements of section 354 of the Public Health Service Act.

ICD-9-CM DIAGNOSIS CODES THAT SUPPORT MEDICAL NECESSITY:
TRUNCATED DIAGNOSIS CODES ARE NOT ACCEPTABLE.
ICD-9-CM code listings may cover a range and include truncated codes. It is the provider’s responsibility to avoid truncated codes by selecting a code(s) carried out to the highest level of specificity and selected from the ICD-9-CM code book appropriate to the year in which the claim is submitted.

It is not enough to link the procedure code to a correct, payable ICD-9-CM diagnosis code. The diagnosis or clinical suspicion must be present for the procedure to be paid.

For screening mammography (76092):

For screening mammography that converts to diagnostic mammography (76090GH or 76091GH):

For diagnostic mammography (76090 or 76091):

For breast echography/sonography (76645) and breast MRI (76093 or 76094):

For ductography (galactography) (76086,76088 and 19030):

REASONS FOR DENIAL:

• A claim submitted without a valid ICD-9-CM diagnosis code will be returned as an incomplete claim under 1833(e).

• A claim submitted without one of the ICD-9-CM diagnosis codes listed in the "ICD-9-CM Diagnosis Codes That Support Medical Necessity" section of this policy will be denied under 1862(a)(1)(A).

• A claim for services rendered in any place of service other than those indicated as payable in the "Limitations" section of this policy will be denied (applies to Part B only).

• It is understood that any claim for mammography/breast sonography/breast MRI/ductography must have (in the patient record) medical justification for the test. A determination that the medical record is lacking such justification will result in a denial under Section 1862 (a)(1)(A).

• A diagnostic mammography, breast ultrasound, breast MRI, or ductogram claim submitted without the UPIN of the treating/ordering physician or qualified non-physician practitioner, will be returned as an incomplete claim under 1833 (e).

• An evaluation and management (E&M) service or consultation by the radiologist, reported on the same day (or subsequent days) as a mammogram, breast sonogram, MRI, or ductogram or their components will be denied.

• An evaluation and management (E&M) service or consultation by a non-radiologist, reported on the same day (or subsequent day) as a mammogram, breast sonogram, breast MRI or ductogram by the same non-radiologist, without documentation indicating that the visit/consult was a separate and distinct service, will be denied.

• The interpretation of a mammogram (76090-76092 with -26 modifier) may not be billed by the provider reviewing the test as part of another service (e.g., E&M service) if the interpretation has already been billed by the mammographer.

• Additional views are part of the mammography service and will be denied when billed separately.

• A claim submitted for mammography without a valid FDA facility certification number will be returned as unprocessable under 1833(e).

• If CPT procedure codes 76091 and 76092 are billed together on the same day by the same provider, CPT procedure code 76092 will be denied.

• If CPT procedure codes 76090 and 76091 are billed together on the same day by the same provider, CPT procedure code 76090 will be denied.

• If CPT procedure codes 76093 and 76094 are billed together on the same day by the same provider, CPT procedure code 76093 will be denied.

• If CPT procedure codes 76086 and 76088 are billed together on the same day by the same provider, CPT procedure code 76086 will be denied.

• A screening mammography claim submitted for a beneficiary under the age of 35 will be denied.

• A screening mammography claim submitted for a beneficiary under the age of 40 who already had a baseline screening mammogram will be denied.

• A screening mammography claim for a beneficiary over the age of 39 that exceeds the yearly screening mammography benefit will be denied.

• A screening mammography claim submitted for a male beneficiary will be denied.

NON-COVERED ICD-9-CM CODES:
Use of any ICD-9-CM diagnosis code not included in the appropriate section of the "ICD-9-CM Diagnosis Codes That Support Medical Necessity" section of this policy will be cause for denial of claims.

SOURCES OF INFORMATION:

• Cancer Medicine, Third Edition, editors Holland, Frei, Best and Morton, Lea and Febiger Publishing, 1993.

• Standards, American College of Radiology, Reston, VA, 1997.

• National Guideline Clearinghouse. "Recommended Breast Cancer Surveillance Guidelines." 1999.

• "Screening vs. Diagnostic mammography." CPT Assistant, Volume 6, Issue 7, July 1996.

• Adams, Song, and Kantorovich, "Breast Symptoms Among Women Enrolled in a Health Maintenance Organization," Annals of Internal Medicine, Vol. 130, No. 8, April 1999.

• "Ductogram (Galactogram): Imaging the Breast Ducts," Breast Health, Imaginiscorp.com, August 5, 1999.

• "What is Breast MRI?" Department of Radiology, Magnetic Resonance Science Center at UC San Francisco.

• "Expanded Role of Ultrasound in Breast Masses," Radiology, Vol. 196, 1995.

• "High Definition Imaging: The role of Ultrasound in the Diagnosis of Breast Cancer (Summary of an International Multicenter Clinical Study)," ATL Ultrasound Reference Library.

• Carrier Medical Directors (Group Health Incorporated, Empire Medicare Services and Blue Shield of Western New York).

• New York State Radiological Society Carrier Advisory Committee representative.

CODING GUIDELINES:

1. Screening Mammogram

   Part B-Use CPT procedure code 76092 when reporting a screening mammogram. This procedure is inherently bilateral. When the facility provides only the technical component, report 76092 with the TC modifier. When only the professional component is provided, report 76092 with the 26 modifier.

   For Part A billing of a screening mammogram use the following:

   • Bill type 14X, 22X, 23X and 85X
   • Revenue code 403-Screening Mammography
   • HCPCS code 76092
   • ICD-9-CM principle diagnosis code V7612-Other Screening Mammography
   • No modifier is required
2. Diagnostic Mammogram

   Part B-Use CPT procedure code 76090 when reporting unilateral diagnostic
   mammography and CPT procedure code 76091 when reporting bilateral diagnostic mammography. Only one of these codes may be reported for any given date of service. When the facility provides only the technical component, report 76090 or 76091 with the TC modifier. When only the professional component is provided, report 76090 or 76091 with the 26 modifier.

   For Part A billing of diagnostic mammogram use the following:

   • Bill type 11x, 12x, 13x, 14x, 18x, 21x, 22x, 23x, 83x and 85X
   • Revenue codes 401- Diagnostic Mammography
   • HCPCS code 76090 or 76091(only one may be reported for any given date of service)
   • ICD-9-cm diagnosis code that supports medical necessity
   • No modifier is required

   NOTE: On bill types 12x, 18x, 21x, 22x and 23x, a diagnostic mammography may be billed without a HCPCS code.

3. Special billing instructions when radiologist interpretation results in additional views:

   Part B-Use the diagnostic code 76090 or 76091 with the GH modifier when a screening mammogram detects a radiographic abnormality and additional views are required. The mammography is no longer considered a screening exam and is reported as a diagnostic mammogram with modifier -GH (diagnostic mammogram converted from screening mammogram on the same day). The screening mammography is not to be separately billed. If additional views are ordered after a screening mammogram in the absence of an abnormal radiographic finding, it would be inappropriate to code the diagnostic code with the GH modifier. In this case, the extra views would not be separately reimbursable.

   Part A-A screening mammogram converted to a diagnostic mammogram should be billed as follows:

4. • Bill type 14x, 22x, 23x and 85x
   • Revenue code 401- Diagnostic Mammography
   • ICD-9-CM diagnosis code that supports medical necessity
   • GH modifier is required
5. Part B-Use CPT procedure code 76645 when reporting breast sonography, unilateral or bilateral. It would be inappropriate to use a 50 modifier or to increase the units field as reimbursement for this code is already based on the procedure being performed bilaterally. Report 76645 with the TC modifier when only the technical component is provided. Report 76645 with the 26 modifier when only the professional component is provided.

   For Part A billing of breast sonography use the following:

   • Bill type 11x, 12x, 13x, 14x, 18x, 21x, 22x, 23x, 28x, 71x, 72x, 83x and 85x.
   • Revenue code 402
   • HCPCS code 76645
   • ICD-9-CM diagnosis code that supports medical necessity
   • No modifier is required
6. Part B-Use CPT procedure code 76093 when reporting a unilateral breast MRI and CPT procedure code 76094 when reporting a bilateral breast MRI. Only one of these codes may be reported for any given date of service. When only the technical component is provided, report 76093 or 76094 with the TC modifier. When only the professional component is provided, report 76093 or 76094 with the 26 modifier.

   For Part A billing of a breast MRI use the following:

   • Bill type 11x, 12x, 13x, 14x, 18x, 21x, 22x, 23x, 28x, 72x, 83x and 85x
   • Revenue code 614
   • HCPCS code 76093 or 76094
   • ICD-9-CM diagnosis code that supports medical necessity
   • No modifier is required
7. Part B-Use CPT procedure code 76086 when reporting a mammary ductogram or galactogram of a single duct and CPT procedure code 76088 when reporting a mammary ductogram or galactogram of multiple ducts. Only one of these codes may be reported for any given date of service. When only the technical component is provided, report 76086 or 76088 with the TC modifier. When only the professional component is provided, report 76086 or 76088 with the 26 modifier. Use CPT procedure code 19030 for the injection of contrast.

   For Part A billing of ductography, use the following:

   • Bill type 11x, 12x, 13x, 14x, 18x, 21x, 22x, 23x, 28x, 71x, 83x and 85x
   • Revenue code 409
   • HCPCS code 76086 or 76088
   • ICD-9-CM diagnosis code that supports medical necessity
   • No modifier is required
8. Where more than one modifier is necessary (e.g., if the service was performed in a rural Health Professional Shortage Area facility and a component modifier is needed), put the mammography modifier (26, TC, or GH) in modifier position 1 and the rural (or other) modifier in modifier position 2. Where more than two modifiers are necessary (e.g., QU, TC, and GH) use the multiple modifier (modifier 99) on the line of coding and place all appropriate modifiers in box 19 when billing on the HCFA 1500 form or in the HA0 record (narrative note) when billing electronically.
9. Claims for screening and diagnostic mammograms must include the 6-digit FDA-assigned certification number of the center/facility in box 32 of the HCFA-1500 form or in the FA0 record, field 31.0 on the electronic National Standard Format (NSF).
10. For diagnostic mammography, breast sonography, breast MRI, and ductograms, the UPIN of the treating/ordering physician or qualified non-physician practitioner is required on the claim. Report this number in box 17a of the HCFA-1500 form or in the EA0 record, field 20.0.
11. For Part B only: Global, technical and/or professional screening mammography, diagnostic mammography, breast sonography, breast MRI and ductography are payable in the following places of service: office (11) and certified mobile unit (99). In addition, the professional component is payable in the following places of service: inpatient hospital (21), outpatient hospital (22), and emergency room (23).
12. When the technical and professional components of mammography are billed separately, they should be billed to the carrier in whose jurisdiction each individual component was performed.
13. The correct coding initiative (CCI for Part B) precludes the billing of the following services on the same day by the same provider:

    • A screening mammogram and a diagnostic mammogram
    • A bilateral diagnostic mammogram and a unilateral diagnostic mammogram
    • A bilateral breast MRI and a unilateral breast MRI
    • A ductogram of a single duct and a ductogram of multiple ducts

14. An evaluation and management (E&M) service by a non-radiologist, performing the components of a mammogram, may be reported on the same day as the mammogram if it is clearly a separate and distinct service and is documented as such in the medical record. The E&M service should be coded with modifier -25 (Part B only).
15. Transportation costs for mammography-certified portable x-ray suppliers providing diagnostic mammography services may be reported with HCPCS procedure code R0070 or R0075. Transportation must be reported on the same claim as the diagnostic mammography test.

DOCUMENTATION REQUIREMENTS:

• Documentation supporting the medical necessity, such as ICD-9-CM diagnosis codes, must be submitted with each claim. Claims submitted without such evidence will be denied as not medically necessary.
• A clear, clinical indication for the diagnostic mammogram/breast sonogram/breast MRI/ductogram must be documented in the medical record, as well as in the referral order. A written referral is required.
• The medical record must include a formal written report describing all the views completed. The formal written report must include the reason for the test, a description of the test, and the interpretation and results of the test, and the name of the physician to whom the report is being sent.
• If the examination began as a screening mammogram and additional films were ordered based on abnormal results, the specific abnormality must be documented in the record and the -GH modifier must be documented on the claim line with the CPT procedure code for a diagnostic mammogram.
• Documentation must be available to Medicare upon request.

OTHER COMMENTS:

• For services that exceed the accepted standard of medical practice and may be deemed not medically necessary, the provider/supplier must provide the patient with an acceptable advance notice of Medicare’s possible denial of payment and a waiver of liability should thus be signed when a provider/supplier does not want to accept the financial responsibility of the service.
• This policy supersedes the following policies:

Empire:     Diagnostic Mammography          - YRad # 02 (Revision #5) as published inThe Medicare News Brief, MNB-98-8, October 1998                                                                       issue, page 27
                Screening Mammography            - Rad # 93 (Revision #1)
GHI:        Mammography -                          - RT-805 
Empire Part A:  Diagnostic Mammography

• This policy was revised and brought back to the Carrier Advisory Committee to address new Health Care Financing Administration (HCFA) regulations regarding a screening mammogram that turns into a diagnostic mammogram and to require more specific record documentation; correct billing procedures for diagnostic mammograms and Evaluation and Management services on the same day; and to address the 1999 focused medical review (FMR) aberrancies of CPT procedure codes 76090, 76091, and 76645. Screening and diagnostic mammography, breast MRI, breast sonography, and ductography services were all combined into one comprehensive policy.

CAC NOTES:

• This policy was presented at the June 9, 1999, Carrier Advisory Committee meeting by Empire Medicare Services.
• This policy does not reflect the sole opinion of the carrier and fiscal intermediary Medical Directors. Although the final decision rests with the carriers or fiscal intermediary, this policy was developed in cooperation with the Carrier Advisory Committee, which includes representatives from the New York State Radiological Society, The New York State Society of Surgeons, the New York State Chapter of the American Society of Internal Medicine-American College of Physicians, the American College of Obstetricians and Gynecologists,the New York State Society of Hematology and Onocology and the Medical Society of the State of New York.

EFFECTIVE DATE: 11/01/99