L11559-LCD

LCD/NCD Portal

Automated World Health

Local Coverage Determination (LCD) for Oral Anticancer Drugs (L11559)

Contractor Information

Contractor Name CGS Administrators, LLC

LCD Information

Document Information

LCD ID Number L11559

LCD Title Oral Anticancer Drugs

Contractor's Determination Number OACD

AMA CPT/ADA CDT Copyright Statement

Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

Alabama Arkansas Colorado Florida Georgia Louisiana Mississippi North Carolina New Mexico Oklahoma Puerto Rico South Carolina Tennessee Texas Virginia Virgin Islands West Virginia

Oversight Region Region IV

DME Region LCD Covers Jurisdiction C

Original Determination Effective Date

For services performed on or after 01/01/1999 Original Determination Ending Date

Revision Effective Date

For services performed on or after 08/05/2011

Revision Ending Date

CMS National Coverage Policy

CMS Benefits Policy Manual (IOM 100-02), Chapter 15, Section 50 - Drugs and Biologicals Social Security Act, Sec. 1861(s)(Q)

Indications and Limitations of Coverage and/or Medical Necessity

For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. For the items addressed in this medical policy, the criteria for reasonable and necessary are defined by the following indications and limitations of coverage and/or medical necessity.

Statutory coverage criteria for oral anticancer drugs are specified in the related Policy Article. In addition, the drug must be reasonable and necessary for the individual patient. If the statutory coverage criteria are met but the drug is not reasonable and necessary for the individual patient it will be denied as not medically necessary.

Drugs may be covered only if dispensed and billed to Medicare by the entity that actually dispenses the drug to the Medicare beneficiary, and that entity must be permitted under all applicable federal, state, and local laws and regulations to dispense drugs. Only entities licensed in the state where they are physically located may bill the DME MAC for oral anticancer and oral antiemetic drugs. Physicians may bill the DME MAC for drugs if all of the following conditions are met: the physician is 1) enrolled as a DMEPOS supplier with the National Supplier Clearinghouse, and 2) dispensing the drug(s) to the Medicare beneficiary, and 3) authorized by the state to dispense drugs as part of the physician's license. Claims submitted by entities not licensed to dispense drugs will be denied for lack of medical necessity.

If the drug on the claim is denied as not medically necessary, the related supply fee will also be denied as not medically necessary.

Coding Information

Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

99999 Not Applicable

CPT/HCPCS Codes

The appearance of a code in this section does not necessarily indicate coverage. HCPCS MODIFIERS:

EY - No physician or other licensed health care provider order for this item or service NATIONAL DRUG CODES (NDC):

The National Drug Code (NDC) is a number, which uniquely identifies a manufacturer's product in terms of the strength of each tablet/capsule, quantity of tablets/capsules in a package, and other packaging details. Suppliers must use the NDC that matches the product dispensed.

The oral anticancer drugs that are addressed in this policy are:

Busulfan Capecitabine Cyclophosphamide Etoposide

Fludarabine phosphate Melphalan Methotrexate Temozolomide Topotecan

HCPCS CODES:

A9270 NON-COVERED ITEM OR SERVICE

J8498 ANTIEMETIC DRUG, RECTAL/SUPPOSITORY, NOT OTHERWISE SPECIFIED J8597 ANTIEMETIC DRUG, ORAL, NOT OTHERWISE SPECIFIED

J8999 PRESCRIPTION DRUG, ORAL, CHEMOTHERAPEUTIC, NOS

Q0511 PHARMACY SUPPLY FEE FOR ORAL ANTI-CANCER, ORAL ANTI-EMETIC OR IMMUNOSUPPRESSIVE DRUG(S); FOR THE FIRST PRESCRIPTION IN A 30-DAY PERIOD

Q0512 PHARMACY SUPPLY FEE FOR ORAL ANTI-CANCER, ORAL ANTI-EMETIC OR IMMUNOSUPPRESSIVE DRUG(S); FOR A SUBSEQUENT PRESCRIPTION IN A 30-DAY PERIOD

ICD-9 Codes that Support Medical Necessity Not specified

For ICD-9 codes relating to statutory coverage, see Policy Article.

AsteriskNoteText

Diagnoses that Support Medical Necessity Not specified

ICD-9 Codes that DO NOT Support Medical Necessity Not specified

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity Not specified

General Information

Documentations Requirements

Section 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider". It is expected that the patient's medical records will reflect the need for the care provided. The patient's medical records include the physician's office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.

An order for each item billed must be signed and dated by the treating physician, kept on file by the supplier, and made available upon request. Items billed before a signed and dated order has been received by the supplier must be submitted with an EY modifier added to each affected HCPCS code.

A new detailed written order is required whenever there is a change in dosage or in the directions for administering the drug.

The ICD-9 diagnosis code describing the condition for which the drug is used must be included on each claim.

Claims for codes J8498 or J8597 must identify the name of the drug, the manufacturer, and the dosage strength of each tablet/suppository/etc. Only quantities of these drugs which meet the coverage criteria listed in the related Policy Article may be billed using these codes. The claim must also indicate which oral anticancer drug is being used and the prescribed frequency of administration of the anticancer drug. This information should be entered in the narrative field of an electronic claim.

Claims using code J8999 must include the name of the drug, the manufacturer, the NDC number, and the number of tablets or capsules dispensed. This information must be entered in the narrative field of an electronic claim.

Refer to the Supplier Manual for more information on documentation requirements.

Appendices

Utilization Guidelines Refer to Indications and Limitations of Coverage and/or Medical Necessity.

Sources of Information and Basis for Decision Advisory Committee Meeting Notes

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 09/01/1999

Revision History Number 009

Revision History Explanation Revision Effective Date: 01/01/2010 CMS NATIONAL COVERAGE POLICY

Added: References to IOM & SSA HCPCS CODES AND MODIFIERS:

Added: Fludarabine phosphate

Revision Effective Date: 04/01/2008 HCPCS CODES AND MODIFIERS:

Added: Topotecan.

03/01/2008 - In accordance with Section 911 of the Medicare Modernization Act, this policy was transitioned to DME MAC CIGNA Government Services (18003) LCD L11517 from DME PSC TrustSolutions (77012) LCD L11517.

Revision Effective Date: 07/01/2007 INDICATIONS AND LIMITATIONS OF COVERAGE:

Removed: DMERC references DOCUMENTATION REQUIREMENTS:

Removed: DMERC references

06/01/2007 - In accordance with Section 911 of the Medicare Modernization Act of 2003, Virginia and West Virginia were transitioned from DME PSC TriCenturion (77011) to DME PSC TrustSolutions (77012).

03/01/2006 - In accordance with Section 911 of the Medicare Modernization Act of 2003, this policy was transitioned to DME PSC TrustSolutions (77012) from DMERC Palmetto GBA (00885).

Revision Effective Date: 01/01/2006 HCPCS CODES AND MODIFIERS: Added: Q0511, Q0512, J8498, J8597. Deleted: G0370, K0415, K0416.

DOCUMENTATION REQUIREMENTS:

Edited: For code changes.

Revised: J8498, J8597, J8999 instructions

Revision Effective Date: 04/01/2005 LMRP converted to LCD and Policy Article

HCPCS CODES AND MODIFIERS:

Added: G0370

Removed: NDC numbers

INDICATIONS AND LIMITATIONS OF COVERAGE:

Added: A statement about denial of supply fees.

Revision Effective Date: 04/01/2004 INDICATIONS AND LIMITATIONS OF COVERAGE:

Added: standard language about who is authorized to dispense drugs and bill Medicare. HCPCS CODES AND MODIFIERS:

Added NDC codes: 00004-1100-20,00004-1101-50

Deleted invalid NDC codes: 00004-1100-13, 00004-1100-22, 00004-1101-13, 00004-1105-51, 00054-8550-03,

00054-8550-05, 00054-8550-06, 00054-8550-07, 00054-8550-10, 00182-1539-01, 00182-1539-95, 00364-

2499-01, 00364-2499-36, 00536-3998-01, 00536-3998-36, 00603-4499-21, 00677-1610-01, 00781-1076-01,

00781-1076-36, 00904-1749-73, 51285-0509-02, 59911-5874-01, 62701-0940-36, 62701-0940-99

Revision Effective Date: 04/01/2003 HCPCS CODES AND MODIFIERS:

Added: EY modifier

INDICATIONS AND LIMITATIONS OF COVERAGE:

Adds standard language concerning coverage of items without an order DOCUMENTATION REQUIREMENTS:

Adds standard language concerning use of EY modifier for items without an order.

The revision date listed below is the date the revision was published and not necessarily the effective date for the revision.

10/01/2002 - Updated list of National Drug Codes. Added codes A9270 and J8999 and instructions for their use.

08/05/2011 - The Jurisdiction C contractor adopted a new business name. This LCD revision only includes the change from CIGNA Government Services to CGS Administrators, LLC. No coverage information was included in this revision and no provider action is needed regarding this revision.

Reason for Change Maintenance (annual review with new changes, formatting, etc.)