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CMS recently released a revised CR 6753 (Transmittal 1888  and Transmittal 110) concerning the coverage of PET scans for cervical cancer.  The National Coverage Determination (NCD) was revised effective for claims with dates of service on and after November 10, 2009 to allow coverage of one initial FDG PET study for staging in beneficiaries who have biopsy-proven cervical cancer.  The PET study is covered when it is needed to determine the location and/or extent of the tumor for the following therapeutic purposes related to initial strategy:

• To determine whether or not the beneficiary is an appropriate candidate for an invasive diagnostic or therapeutic procedure; or,
• To determine the optimal anatomic location for an invasive procedure; or
• To determine the anatomic extent of the tumor when the recommended anti-tumor treatment reasonably depends on the extent of the tumor.

The NCD also determined that there is no credible evidence that PET imaging is useful in making initial diagnosis of cervical cancer or in improving health outcomes; therefore, CMS continues to non-cover FDG PET for the initial diagnosis of cervical cancer related to initial treatment strategy.

FDG Pet imaging for initial staging of cervical cancer related to initial treatment strategy was previously covered under the Coverage with Evidence Development (CED) prospective data collection requirements.  This CR removes the CED requirements; NOPR data reporting is no longer necessary and the –Q0 modifier is no longer necessary on claims for FDG PET services for cervical cancer.

Claims for FDG PET for cervical cancer billed to inform initial treatment must include all the following or they will “return to provider.

• PET or PET/CT CPT code (78608, 78811, 78812, 78813, 78814, 78815, or 78816), and
• -PI modifier (PET Tumor initial treatment strategy), and
• ICD-9 cervical cancer diagnosis code.

For more information, please see the Transmittals listed above or view the MLN Matters Article.  The implementation date of this CR was January 4, 2010.

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In Transmittal 1838 released October 28, 2009, CMS published information concerning the requirement for separate claims when both covered and non-covered procedures are performed during an inpatient hospital admission. 

Inpatient hospital MS-DRG assignment is determined by the patient’s principal diagnosis, secondary diagnoses, and any procedures performed, as well as age, gender, and discharge disposition.  When both covered and non-covered procedures are reported during an inpatient hospital admission, the Medicare claims processing system is unable to decipher what procedure code(s) is/are non-covered when grouping to the MS-DRG.  Therefore, effective for inpatient discharges on and after April 1, 2010, hospitals must submit ICD-9 CM codes for non-covered procedures performed in the same inpatient stay with covered procedure(s) on a separate claim. 

Hospitals must separate a hospital stay into two claims when both covered and non-covered procedures are reported. 

• One claim with covered services/procedures unrelated to the non-covered ICD-9-CM procedures on a Type of Bill (TOB) 11X (with the exception of TOB 110), and
• The other claim with the non-covered services/procedures on a TOB 110 (no-pay claim).
  The Statement Covers Period should match on both the covered and the non-covered claims.

Medicare will deny no-pay claims as non-covered with:

• claim adjustment reason code 50 and
• group code CO (Contractual Obligation) if a Hospital Issued Notice of Non-Coverage (HINN) was not issued or
• group code PR (Patient Responsibility) if a HINN was issued.

Note: Hospitals do not have to submit claims for statutorily non-covered services (e.g. cosmetic surgery), but may voluntarily wish to do so; for example, to receive a Medicare denial.  This transmittal requires that ICD-9 CM codes for non-covered procedures not be reported on the same inpatient claim with covered services.  If the hospital wishes to bill non-covered procedure(s) and related non-covered charges for whatever reason (e.g. a Medicare denial), the hospital may submit such services/charges on a TOB 110 (no-pay claim).

Refer to the complete transmittal or MLN Matters Article 6547 for more information.

In 2008, Medicare changed the regulations regarding use of the Advance Beneficiary Notice (ABN) to allow use of the ABN for voluntary notices.  Prior to this change, ABNs were only used to notify beneficiaries of services that were likely to be denied for reasons of medical necessity.  Providers could use the Notice of Exclusion of Medicare Benefits (NEMB) to notify beneficiaries of services that were excluded by statute or for which no Medicare benefit category exists.  The change retired the NEMB and allowed ABNs to be used for both mandatory and voluntary uses.

In Transmittal 1840, Medicare has updated two HCPCS modifiers to distinguish between voluntary and required uses of the ABN, effective April 1, 2010.

• Modifier -GA has been redefined to mean “Waiver of Liability Statement Issued as Required by Payer Policy,” and should be used to report when a required ABN was issued for a service.
• Modifier -GX is a new modifier with the definition “Notice of Liability Issued, Voluntary Under Payer Policy.”  It was created to be used to report when a voluntary ABN was issued for a service.

Modifier -GA should only be used to report when a required ABN was issued.  ABNs are required in order to shift liability to the beneficiary when otherwise covered services are expected to be denied, such as services that are not medically necessary based on coverage determinations.  Line items with the –GA modifier should continue to be submitted with covered charges.  Modifier -GA should not be reported in association with any other liability-related modifiers.  Medicare will deny institutional claims submitted with modifier -GA using claim adjustment reason code 50 and will assign beneficiary liability.

Modifier –GX should be used when beneficiaries are provided voluntary notices of liability for statutorily-excluded services.  Providers are not required to give notification of statutorily-excluded services, but may choose to do so to aid the beneficiary.  The –GX modifier must be submitted with non-covered charges only.  Your claim will be returned if the –GX modifier is reported on a line with covered charges.  It may be reported on the same line as modifiers –GY or –TS that indicate beneficiary liability.  It should not be reported on the same line with modifiers –EY, –GA, -GL, -GZ, -KB, -QL or –TQ.  Medicare will automatically deny lines submitted with modifier –GX and non-covered charges using claim adjustment reason code 50 and will assign beneficiary liability. 

Please refer to Transmittal 1840 or MLN Matters MM6563 for more information.

Medicare will cover the administration of the H1N1 flu vaccine in addition to coverage of the regular seasonal influenza vaccine and its administration.  Two new HCPCS codes have been created for the H1N1 influenza vaccine, effective for dates of service on and after September 1, 2009:

• G9141—Influenza A (H1N1) immunization administration (includes the physician counseling the patient/family)
• G9142---Influenza A (H1N1) vaccine, any route of administration

HCPCS code G9141 has an OPPS payment rate of $24.89 for CY 2009 and beneficiary co-payment and deductible do not apply.  Providers should report one unit of HCPCS code G9141 for each administration of the H1N1 vaccine using diagnosis code V04.81 and revenue code 771.  Providers who normally roster bill for immunizations may submit H1N1 administration claims using the roster billing format.  The same roster billing information is required as for seasonal influenza roster claims.

Payment will not be made for HCPCS code G9142 (status indicator ‘E’ under OPPS) since the H1N1 vaccine will be supplied to providers at no cost.  Providers do not need to submit G9142 on the claim, but if it appears on the claim, only the line item will deny.

Since the H1N1 vaccine was released earlier than anticipated, the October IOCE contained an effective date for the new HCPCS codes of October 1, 2009.  The effective date will be corrected to September 1, 2009 with the January IOCE update.  Claims for H1N1 vaccine administration in September 2009 will be held until the installation of the January IOCE release.

Additional information on Medicare coverage of H1N1 and seasonal influenza vaccines can be found at MLN Matters Article SE0920 and MLN Matters Article MM6626.

Effective April 6, 2009, CMS expanded the coverage of PET scans for initial treatment (diagnosis and staging) and subsequent treatment (restaging and monitoring response to treatment) for most solid tumors.  FDG PET scans for certain cancers, especially for subsequent treatments, must still be provided under the coverage with evidence development/coverage with study participation (CED/CSP) paradigm.  Please see the table at the end of this article for a summary of coverage by tumor type.  Coverage changes are indicated with an asterisk (*).

On July 17, 2009 CMS released two transmittals manualizing the NCDs and providing billing instructions.  However, these transmittals were rescinded and replaced with Transmittal 1817 and Transmittal 106 released September 18, 2009.  The new transmittals added some CPT codes and removed the specification of a diagnosis code range. 

The transmittals introduce two new modifiers and provide billing instructions for reporting PET scans.  Hospitals are required to begin using the new modifiers October 19, 2009 for claims with date of service on or after April 6, 2009.

PI – Positron Emission Tomography (PET) or PET/Computed Tomography (CT) to inform the initial treatment strategy of tumors that are biopsy proven or strongly suspected of being cancerous based on other diagnostic testing.  Short descriptor: PET tumor init tx strat

PS – Positron Emission Tomography (PET) or PET/Computed Tomography (CT) to inform the subsequent treatment strategy of cancerous tumors when the beneficiary’s treatment physician determines that the PET study is needed to inform subsequent anti-tumor strategy. Short descriptor: PET tumor subsq tx strategy

Claims for PET Scans for Initial Treatment Strategy for Covered Cancers must include:

• PET/PET/CT CPT code (78608, 78811, 78812, 78813, 78814, 78815,78816) and
• -PI modifier
• Coverage limited to only (1) one time per cancer type

Claims for PET Scans for Subsequent Treatment Strategy for Covered Cancers must include:

•  PET/PET/CT CPT code (78608, 78811, 78812, 78813, 78814, 78815,78816) and
• -PS modifier and
•  ICD-9 cancer diagnosis code

Claims for PET Scans for Initial or Subsequent Strategy under CED must include:

•  PET/PET/CT CPT code (78608, 78811, 78812, 78813, 78814, 78815,78816) and
• –PI modifier or –PS modifier as appropriate and
• ICD-9 cancer diagnosis code and
• Modifier –QO
• Diagnosis code V70.7 and condition code 30 for institutional claims to denote a clinical trial
• National Oncologic PET Registry (NOPR) data collection required

Hospitals need to develop internal processes to:
- determine the reason for an oncologic PET scan when it is ordered – i.e. diagnosis or staging (initial treatment strategy) or restaging or monitoring response to treatment (subsequent treatment strategy)
- ensure the appropriate modifier(s) are present on the claim
- verify an appropriate diagnosis is provided and coded

Appendix A: Effect of Coverage Changes on Oncologic Uses of FDG PET
See NCD Manual for specific coverage language.

 * Formerly “diagnosis” and “staging”
** Formerly “restaging” and “monitoring response to treatment when a change in treatment is anticipated”
N/C = noncover

(1) Cervix: Covered for the detection of pre-treatment metastases (i.e., staging) in newly diagnosed cervical cancer subsequent to conventional imaging that is negative for extra-pelvic metastasis. All other uses are CED.
(2) Breast: Noncovered for diagnosis and/or initial staging of axillary lymph nodes. Covered for initial staging of metastatic disease.
(3) Melanoma: Noncovered for initial staging of regional lymph nodes. All other uses for initial staging are covered.
(4) Thyroid: Covered for subsequent treatment strategy of recurrent or residual thyroid cancer of follicular cell origin previously treated by thyroidectomy and radioiodine ablation and have a serum thyroglobulin >10ng/ml and have a negative I-131 whole body scan. All other uses for subsequent treatment strategy are CED.

On July 31, 2009, CMS released Transmittal 526 (CR 6518) concerning the correct coding of facet joint injections, especially relating to bilateral injections.  Please see the following excerpts from the MLN Matters Article .

“The primary codes, 64470 and 64475, are used for a single injection in the cervical/thoracic or lumbar/sacral area of the spine, respectively. Each primary code has an associated add-on code for use when injections are provided at multiple spinal levels. The add-on codes are 64472 (cervical/thoracic) and 64476 (lumbar/sacral).

Bilateral injections are performed on the right and left sides of one joint level. The Centers for Medicare & Medicaid Services (CMS) requires physicians to indicate a bilateral injection by using billing modifier 50 and the appropriate CPT code. If a physician performs multiple bilateral injections, modifier 50 should accompany each facet joint injection CPT code.

To summarize, when facet joint injections are performed on both the right and left sides of a level of the spine, physicians must use modifier 50 and the appropriate primary CPT code. When facet joint injections are performed at more than one level, physicians must use add-on codes 64472 or 64476 to represent additional levels of the spine injected.”

This is the fourth in a series of information from government entities concerning the coding and billing of facet joint injections.  Previous information includes: an OIG report that found errors in the billing of facet joint injections; a CMS transmittal that instructed Medicare contractors to strengthen program safeguards to prevent improper payments for facet joint injections; and Cahaba GBA probe review findings that reported issues with missing modifiers and incomplete documentation.  Although some of these articles stress physician billing and coding practices, hospitals should also take necessary actions to ensure they are documenting, coding and billing these services appropriately.

CMS Transmittal 1775 (CR 6478) released July 24, 2009 adds two new point of origin (formerly source of admission) codes for use in Field Locator 15 on the UB-04 (CMS 1450).  Field Locator 15 of the UB-04 and its electronic equivalence is a required field on all institutional inpatient claims and outpatient registrations for diagnostic testing services.  The new codes will be accepted by Medicare’s claims processing systems as of January 4, 2010.

The new codes are:

 E – Transfer from Ambulatory Surgical Center:
- Inpatient: This patient was admitted to this facility as a transfer from an ambulatory surgery center.
- Outpatient: The patient was referred to this facility for outpatient or referenced diagnostic services from an ambulatory surgery center.

 F – Transfer from Hospice and is Under a Hospice Plan of Care or Enrolled in a Hospice Program:
- Inpatient: The patient was admitted to this facility as a transfer from hospice.
- Outpatient: The patient was referred to this facility for outpatient or referenced diagnostic services from a hospice.

Please share this information with the Registration/Admission and Quality Abstraction departments in your hospital.

For more information, you can view the CMS Transmittal 1775 or the MLN Matters Article.

On January 15, 2009, the Centers for Medicare & Medicaid Services (CMS) finalized National Coverage Determinations (NCDs) for non-coverage of three surgical “never events.”  Per the NCDs, Medicare will not cover a particular surgery or invasive procedure if:

1. the wrong procedure is performed on a patient,
2.  the procedure is performed on the wrong body part, or 
3.  the procedure is performed on the wrong patient. 

On June 12, 2009, CMS released two transmittals that manualize the determinations, further define related non-covered services, and provide billing instructions. 

The effective date of the transmittals is for discharges and services on or after January 15, 2009, but the implementation date, including availability of the new HCPCS modifiers is July 6, 2009 for Part B claims and October 5, 2009 for Part A claims.  Contractors will not go back and search for erroneously processed claims prior to the implementation dates but will adjust any claims brought to their attention.

Related Services

Medicare will not cover hospitalizations and other services related to these non-covered procedures as defined in the Medicare Benefit Policy Manual, Chapter 1 , Sections 10 and 120 and Chapter 16, Section 180. 

• Related services do not include performance of the correct procedure
• All services provided in the operating room when an error occurs are considered related and therefore not covered
• All providers in the operating room when the error occurs, who could bill individually for their services, are not eligible for payment
• All related services provided during the same hospitalization in which the error occurred are not covered
• Following hospital discharge, any reasonable and necessary services are covered regardless of whether they are or are not related to the surgical error.

Billing Instructions – Inpatient Admission

If covered services were provided during the same hospitalization in which a surgical error occurred, the hospital should submit two separate claims: one claim with covered services and procedures unrelated to the erroneous surgery on a Type of Bill (TOB) 11X (except not 110) and another claim with the non-covered services and procedures related to the error on a TOB 110 (no-pay claim).  On the claim for the non-covered services (TOB 110), hospitals should enter one of the following 2-digit surgical error codes in the Remarks field.

• MX: wrong surgery on patient
• MY: surgery on wrong body part
• MZ: surgery on wrong patient

Claims submitted on a TOB 110 with one of the surgical error codes will be denied for payment.

Billing Instructions – Hospital Outpatient

On hospital outpatient claims for services where one of the non-covered surgical events occurred, the hospital should append one of the following applicable HCPCS modifiers to all lines related to the surgical error.

• PA: surgery on wrong body part
• PB: surgery on wrong patient
• PC: wrong surgery on patient

All line-items with one of the above HCPCS modifiers will be denied for payment.

CMS cannot envision a scenario in which HINNs or ABNs could be validly delivered in these NCD cases.  Medicare contractors will maintain a list of surgical error occurrences and will review beneficiary history for other claims potentially related to the surgical error.  If the contractor determines that related services should not have been covered, they will deny payment for the related services and recover overpayments when appropriate. 

Links to the CMS transmittals:
http://www.cms.hhs.gov/transmittals/downloads/R1755CP.pdf
http://www.cms.hhs.gov/transmittals/downloads/R101NCD.pdf