News & Updates

L25820 - Drugs and Biologicals, Coverage of, for Label and Off-Label Uses
R6 (Effective February 1, 2009): Internal: The following article has been added: A48420 - Intravenous Iron Sucrose and Iron Dextran. No notice period required and none given.

A46089 - Temsirolimus (Torisel ™) – Related to LCD L25820
Correction (published 01/08/2009): ICD-9-CM code 197.7 has been added to the ICD-9-CM tables and the description for ICD-9-CM code 197.0 has been corrected in the "ICD-9-CM codes that are Covered" section of the article. These were inadvertently missed when the ICD-9-CM codes were added to the article in October. The year “2009” has been corrected in the first guideline under the “For claims submitted to the carrier or Part B MAC” section.

A46095 - Bevacizumab (e.g., Avastin™) - Related to LCD L25820
Correction (published 01/15/2009): the effective date for ICD-9-CM codes 362.07, 362.16 and 362.83 has been changed to 07/18/2008. The terminology for ICD-9-CM codes 191.0-191.9 has been corrected.

A46758 - Paclitaxel (e.g., Taxol®/Abraxane ™) - Related to LCD L25820
Correction (published 01/15/2009): the expanded indication for albumin-bound paclitaxel has been corrected to include recurrent breast cancer.

A46096 - Zoledronic Acid (e.g., Zometa ®, Reclast® ) – Related to LCD L25820
Correction (published 01/15/2009): ICD-9-CM codes 995.29 and V12.79 have been removed from the article on the CMS Medicare Coverage Database. These ICD-9-CM codes should have been removed from the secondary ICD-9 table for the management of osteoporosis as a consequence of the endocrine (including aromatase inhibitors) treatment of malignancy with the last revision.

A46754 - Alteplase Recombinant (e.g., Cathflo® Activase ®) – Related to LCD L25820
Correction (published 01/29/2009): the description for ICD-9-CM code 410.72 has been corrected on the Web site version to match what is listed in the CMS Medicare Coverage Database.

A47582 - Bortezomib (e.g., Velcade®) – Related to LCD L25820 - Correction (published 01/29/2009): the description for ICD-9-CM code 273.3 has been corrected on the Web site version to match what is listed in the CMS Medicare Coverage Database.

A47586 - Etoposide (Etopophos®, Toposar®, Vepesid®, VP-16) – Related to LCD L25820 - Correction (published 01/29/2009): the description for ICD-9-CM codes 183.3 and 183.5 have been corrected on the Web site version to match what is listed in the CMS Medicare Coverage Database.

A46103 - Gemcitabine Hydrochloride (e.g., Gemzar®) – Related to LCD L25820
Correction (published 01/29/2009): the description for ICD-9-CM codes 239.6, 239.8 and 239.9 has been corrected on the Web site version to match what is listed in the CMS Medicare Coverage Database.

A47579 - Ifosfamide (Ifex) - Related to LCD L25820 - Correction (published 01/29/2009): the spelling of the word “brain” has been corrected for ICD-9-CM code 198.3 on the version published on the Web site.

A47381 - Intravenous Immune Globulin (IVIG) - Related to LCD L25820
Correction (published 01/29/2009): a duplicate statement in the “ICD-9-CM Codes that are Covered” section has been removed. The word “Limitations” has been changed to “Indications” in the following statement: “For ICD-9-CM codes: 042, 283.0, 283.10, 283.19, 283.9, 287.30, 287.31 and 996.85 please refer to the “Indications” section for specific age requirements.”

A46105 - for Intravenous Iron Therapy (Sodium Ferric Gluconate) – Related to LCD L25820 - Correction (published 01/29/2009): HCPCS code J1756 has been removed from the article on the CMS Medicare Coverage Database. The description for ICD-9-CM codes 280.1 and V66.2 has been corrected on the Web site version to match what is listed in the CMS Medicare Coverage Database.

A46104 - Micafungin Sodium (e.g., Mycamine™) – Related to LCD L25820
Correction (published 01/29/2009): the description for ICD-9-CM code V07.8 has been corrected on the Web site version to match what is listed in the CMS Medicare Coverage Database.

A46088 - Omalizumab (e.g., Xolair®) – Related to LCD L25820 - Correction (published 01/29/2009): the description for ICD-9-CM code 995.3 has been corrected on the Web site version to match what is listed in the CMS Medicare Coverage Database.

A46756 - Oxaliplatin (e.g., Eloxatin®) - Related to LCD L25820 - Correction (published 01/29/2009): the description for ICD-9-CM codes 183.3 and 183.5 have been corrected on the Web site version to match what is listed in the CMS Medicare Coverage Database.

A46738 - Pamidronate Disodium for Injection (e.g., Aredia®) - Related to LCD L25820
Correction (published 01/29/2009): the description for ICD-9-CM code V58.69 has been corrected on the Web site version to match what is listed in the CMS Medicare Coverage Database.

Injectable drug update
The following policy updates will be effective for all claims
processed on or after March 20, 2009, regardless of the date
of service. In addition to current policy the following updates
and processing changes will be applied.
Palonosetron HCl (J2469) — Claims reporting diagnosis V58.12 will be
reviewed for criteria: Diagnoses 995.2 and V66.2 will be considered not
medically appropriate.
Bortezomib (J9041) — Claims reporting diagnoses 200.20-200.28,
202.80 will be reviewed for criteria.
Pemetrexed Disodium (J9305) — Claims reporting diagnosis 162.0 will be
reviewed for criteria.
Rituximab (J9310) — Claims reporting diagnosis 287.4 will be considered
not medically appropriate: 287.4.
Fulvestrant (J9395) — Claims reporting diagnosis 175.0-175.9 will be
reviewed for criteria: 175.0-175.9.
Zoledronic acid (Zometa) (J3487) — Claims reporting diagnoses 200.00-
202.98, 203.10-203.82, 204.00-208.91 will be reviewed for criteria

National Government Services Medical Policy Revision for: Drugs and Biologicals, Coverage of, for Label and Off Label Uses
LCD and Coverage Articles Part A & B Effective January 1, 2009
LCD for Drugs and Biologicals, Coverage of, for Label and Off-Label Uses (L25820)
R5* (effective 01/01/2009); Internal; the LCD has been revised to include compendia recognized by CMS based on Change Request 6191 (Compendia as Authoritative Sources for Use in the Determination of a Medically Accepted Indication of Drugs and Biologicals Used Off-Label in an Anti-Cancer Chemotherapeutic Regimen. Added Internet Only Manual (IOM) language to the “Limitations” section. The following articles have been added: A48208 - Filgrastim, Pegfilgrastim (e.g., Neupogen®, Neulasta TM), A48339 – Floxuridine, A48211 - Thyrotropin Alfa (Thyrogen®) and A48213 - Vitamin B-12 Injections. The following article has been retired: A46093 – Rituximab (Rituxan®). Minor changes were made to reflect current template language. Although revision R5 is effective 01/01/2009, the addition of the compendia based on Change Request 6191 is effective 11/25/2008. No notice period required and none given.

Clarification of NGS’s policy for coverage of Anti-Emetics effective January 1, 2009.

The following is an excerpt from NGS policy (see link below for full policy).
This policy is effective January 1, 2009 but will not be implemented until March 1, 2009.

…not only does the indication for the use of the drug need to meet medical necessity requirements, but the route of administration is also subject to medical necessity criteria. Contractors must continue to apply the policy that not only the drug is medically reasonable and necessary for any individual claim, but also that the route of administration is medically reasonable and necessary. That is, if a drug is available in both oral and injectable forms, the injectable form of the drug must be medically reasonable and necessary as compared to using the oral form .(Pub 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50.2 - Determining Self-Administration of Drug or Biological (Rev. 91; Issued: 06-20-08; Effective/Implementation Date: 07-21-08)). Medication given by injection (parenterally) is not covered if standard medical practice indicates that the administration of the medication by mouth (orally) is effective and is an accepted or preferred method of administration. (Pub 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50.4.3) Specifically, for anti-emetic medication, CMS states: It is recognized that a limited number of patients will fail on oral anti-emetic drugs. Intravenous anti-emetics may be covered (subject to the rules of medical necessity) when furnished to patients who fail on oral anti-emetic therapy. (Pub 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50.5.4)

Link to full policy:
http://www.ngsmedicare.com/NGSMedicare/lcd/L25820_active_lcd.htm

NGS
Drugs and Biologicals, Coverage of, for Label and Off-Label Uses - Supplemental Instructions Article
Article # A44930

Claims for drug administration services must be submitted on the same claim as that for the drug.

When the drug is purchased by the beneficiary, or when the drug was supplied without charge by the manufacturer, it should NOT be billed to Medicare by the provider, even with a submitted charge of $0.00. However, the name and dosage of the drug may be listed in the narrative record of the claim, to avoid requests for additional information on the claim.

When billing for an IV drug which has an available oral form, please also report one of the following ICD-9 codes (whichever is appropriate).

579.3 OTHER AND UNSPECIFIED POSTSURGICAL NONABSORPTION

579.9 UNSPECIFIED INTESTINAL MALABSORPTION

995.29 UNSPECIFIED ADVERSE EFFECT OF OTHER DRUG, MEDICINAL AND BIOLOGICAL SUBSTANCE

V12.79 PERSONAL HISTORY OF OTHER SPECIFIED DIGESTIVE SYSTEM DISEASES

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Empire Blue Cross Blue Shield

Injectable drug update
The following policy updates will be effective for all claims processed on or after March 20, 2009, regardless of the date of service. In addition to current policy the following updates and processing changes will be applied.
Palonosetron HCl (J2469) — Claims reporting diagnosis V58.12 will be reviewed for criteria: Diagnoses 995.2 and V66.2 will be considered not medically appropriate.
Bortezomib (J9041) — Claims reporting diagnoses 200.20-200.28, 202.80 will be reviewed for criteria.
Pemetrexed Disodium (J9305) — Claims reporting diagnosis 162.0 will be reviewed for criteria.
Rituximab (J9310) — Claims reporting diagnosis 287.4 will be considered not medically appropriate: 287.4.
Fulvestrant (J9395) — Claims reporting diagnosis 175.0-175.9 will be reviewed for criteria: 175.0-175.9.
Zoledronic acid (Zometa) (J3487) — Claims reporting diagnoses 200.00-202.98, 203.10-203.82, 204.00-208.91 will be reviewed for criteria.

Fee schedules are available
If you need a copy of your fee schedule, you can fax a request to the attention of Provider Network Management at 718-312-6240. You can also obtain fee schedule information on our Physician Online Services at empireblue.com.
Click on the “Physicians” tab and then register or log in. From your homepage, select “Searches” then “Fee Schedules.”You can view fees by CPT code and modifier.

MediBlueSM news
Annual benefits changes for Medicare Advantage plan members will be effective January 1, 2009. The changes apply to members enrolled in Empire’s MediBlue HMO, MediBlue PPO and MediBlue Total Solutions plans.

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Coding for Drugs and Biologicals
Information for General Infusion Information, Chemotherapy Infusions and Unlisted Drug Coding

Sections:

General Infusion Information

Chemotherapy Drugs, Monoclonal Antibodies, and Biological Response Modifiers

Unlisted Drug Code Use

General Infusion Information
There are CPT codes for several different types of infusions and injections for drugs and biologicals. These include codes for chemotherapy infusions and injections, therapeutic, prophylactic and diagnostic infusions, and injections and hydration.

The CPT Manual published by the American Medical Association (2008) describes chemotherapy drugs and biologicals infusions and injections as requiring “physician work and/or clinical staff monitoring well beyond that of therapeutic drug agents (90760-90779) because the incidence of severe adverse patient reactions are typically greater.” (p424) These codes are paid at a higher rate to reflect the greater physician work and other resources required to safely administer these substances.

For the therapeutic, prophylactic and diagnostic infusions and injections codes (90760-90779), the CPT states that: “if performed to facilitate the infusion or injection, the following services are included and are not reported separately:
- use of local anesthesia;
- IV start;
- access to indwelling IV, subcutaneous catheter or port;
- flush at conclusion of infusion;
- standard tubing, syringes, and supplies.” (p.383)
The CPT defines hydration as “pre-packaged fluid and electrolytes… not the infusion of drugs or other substances.” “Typically, such infusions require little special handling to prepare or dispose of, and staff that administer these do not typically require advanced practice training. After initial set up, infusion typically entails little patient risk and thus little monitoring.” (p.384)

For additional information on these services, and the rules for billing the initial and subsequent hours, please consult the CPT manual.

Documentation for Infusions
Start and stop times must be evident in the documentation in order to bill units for hours infused. If no start or stop time or total hours infused can be determined from the documentation, the best course is to query the clinician. If, in the circumstance that NO times are evident, an IV push code may be appropriate for billing since no infusion is supported beyond 15 minutes. Upon medical review, these services may be denied for insufficient documentation if billed as hours of infusion.

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Chemotherapy
General Information

Chemotherapy drugs are defined by the HCPCS Level II as drugs occurring in the range of J9000 through J9999.
Drugs in this range are assumed to require the complex drug administration services and physician supervision requirements inherent in CPT codes 96401-96417. The use these codes depends upon the drug administered, not the patient’s diagnosis, since many anti-neoplastic medications are used for treatment of illnesses besides neoplasm.
In addition to non-radionuclide anti-neoplastic drugs, HCPCS Level II codes J9000-J9999 also include biologic response modifiers (BRMs), monoclonal antibodies (MAs), and hormonal anti-neoplastics (HANs), the administration of which may be billed with chemotherapy administration codes.

Biological Response Modifiers

Due to the complexity of their administration, certain other drugs meet the requirements for billing as chemotherapy injection or infusion services. Additional BRMs outside the J9000-J9999 range that are appropriate to use with these codes are listed below.

Biologic Response Modifiers
J0215	Alefacept 0.5 mg
J7516	Cyclosporin Parenteral 250 mg
J7525	Tacrolimus 5 mg
Q3025	Interferon beta 1-a 11 mcg IM

The anti-anemia or anti-emetic drugs used in cancer care do not warrant use of the chemotherapy administration and injection codes. Neupogen, Neulasta, Darbepoetin, Aranesp, Epogen and other similar drugs are not considered biological response modifiers for the purpose of coding drug administration and infusions and should be billed with the appropriate therapeutic injection codes.

Monoclonal Antibodies

Monoclonal antibodies are frequently identified with generic drug names ending in “mab,” such as rituximab (J9310), trastuzumab (J9355), bevacizumab (J3095), etc. All MAs are appropriate for use with the chemotherapy administration codes.

Hormonal Anti-Neoplastic Drugs

Hormonal anti-neoplastic drugs that lay outside the J9000-J9999 HCPCS range that may utilize the chemotherapy infusion or injection codes are listed below.

Hormonal Anti-neoplastics
J0128	Aberelix 10 mg
J0970	Estradiol valerate up to 40 mg
J1000	Depo-estradiol cypionate up to 5 mg
J1380	Estradiol valerate 10 mg
J1390	Estradiol valerate 20 mg
J1410	Estrogen conjugate 25 mg
J1435	Estrone 1 mg
J3315	Triptorelin pamoate 3.75 mg

Note: the lists of drugs and biologicals in this article are subject to change as new drugs are reviewed and evaluated.

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Unlisted Codes for Drugs and Biologicals (J3490, J3590, J9999, and C9399)
Unlisted codes should only be applied when no other code adequately describes the service.

Unlisted codes are commonly used when the:
- drug/biological does not have a specific HCPCS code;
- drug/biological is administered by a route other than stated in the code;
- amount of drug or biological is less than the amount, or of a different concentration, than specified in the HCPCS descriptor.
For example, a 25 mg injection of Demerol is administered from a 25 mg vial. There is currently no HCPCS code for a 25 mg vial of Demerol. It would be appropriate to use J3490 in this instance. The only HCPCS code available for Demerol is J2175; for a 100 mg vial. If a 25mg injection of Demerol is administered from a 100 mg vial, then J2175 should be used with waste reported and documented in the medical record.
- Preparation or make up of the drug or biological is other than specified in the descriptor, such as when billing compounded drugs for an implantable pain pump, or re-packaged drugs.
Unlisted codes J3490, J3590, and J9999 billed to the Part A fiscal intermediary or MAC under the hospital OPPS are paid at a lesser rate or are packaged into the payment for other services on the claim. For non-OPPS facilities such as critical access hospitals (CAHs) and dialysis facilities, the claim is suspended for these codes and drugs are priced according to the remarks on the claim.

Facilities under the hospital OPPS may use code C9399, billed as one unit, when the drug is FDA approved, but does not have an assigned HCPCS or the assigned HCPCS is not yet effective. Claims with C9399 are suspended and the drug is manually priced according to the remarks on the claim.

Unlisted codes J3490, J3590, and J9999 billed to the Part B carrier or MAC are priced manually. For billing these unlisted codes the claim must include in Item 19 of the CMS-1500 or electronic equivalent:
- Unit of service (= 1);
- Name of the drug;
- Dose administered (mg, cc, etc.);
- Amount wasted (if any);
- Route; and
- NDC number (National Drug Code Number).

Claims billed to the carrier with C9399 will be rejected.

References:
Current Procedural Terminology 2008, American Medical Association
CMS Publication 100-4, Claims Processing Manual, Chapter 12, Section 30.5
CMS Publication 100-2, Benefit Policy Manual, Chapter 15, Section 50

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Transcript Now Available – ICD-10-CM/PCS National Provider Conference Call for Other Part A and Part B Providers