L11560-LCD

LCD/NCD Portal

Automated World Health

Local Coverage Determination (LCD) for Oral Antiemetic Drugs

(Replacement for Intravenous Antiemetics) (L11560)

Contractor Information

Contractor Name CGS Administrators, LLC

LCD Information

Document Information

LCD ID Number L11560

LCD Title Oral Antiemetic Drugs (Replacement for Intravenous Antiemetics)

Contractor's Determination Number OEMT

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 01/01/2012

Revision Ending Date

CMS National Coverage Policy

Pub. 100-3, Medicare National Coverge Deteminations Manual, Chapter 1, Section 110.18 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 local coverage determination, the criteria for "reasonable and necessary", based on Social Security Act §1862(a)(1)(A) provisions, are defined by the following indications and limitations of coverage and/or medical necessity.

The statutory coverage criteria for oral antiemetics drugs addressed in this policy are specified in the related Policy Article.

Aprepitant (J8501) and dexamethasone (J8540) are covered if, in addition to meeting the statutory coverage criteria specified in the related Policy Article, they are administered to beneficiaries who are receiving one or more of the following anti-cancer chemotherapeutic agents:

• Carmustine

• Cisplatin

• Cyclophosphamide

• Dacarbazine

• Mechlorethamine

• Streptozocin

• Doxorubicin

• Epirubicin

• Lomustine

If aprepitant and dexamethasone meet the statutory coverage criteria, but are not used with one of the preceding chemotherapeutic agents, they will be denied as not reasonable and necessary.

The supplier may dispense only a single course of oral antiemetic drugs at one time unless it is known there will be more than a single course of therapy in the month, in which case the supplier may dispense no more than a single month’s supply.

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 for 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 reasonable and necessary, the supply fee will be denied as not reasonable and necessary.

Refer to the Oral Anticancer Drugs policy for information on coverage of antiemetic drugs used in conjunction with oral anticancer drugs.

REFILL REQUIREMENTS

For DMEPOS items and supplies provided on a recurring basis, billing must be based on prospective, not retrospective use. For DMEPOS products that are supplied as refills to the original order, suppliers must contact the beneficiary prior to dispensing the refill and not automatically ship on a pre-determined basis, even if authorized by the beneficiary. This shall be done to ensure that the refilled item remains reasonable and necessary, existing supplies are approaching exhaustion, and to confirm any changes or modifications to the order. Contact with the beneficiary or designee regarding refills must take place no sooner than 14 calendar days prior to the delivery/shipping date. For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the end of usage for the current product. This is regardless of which delivery method is utilized. (CMS Program Integrity Manual, Internet-Only Manual, CMS Pub. 100-8, Chapter 5, Section 5.2.6).

For all DMEPOS items that are provided on a recurring basis, suppliers are required to have contact with the beneficiary or caregiver/designee prior to dispensing a new supply of items. Suppliers must not deliver refills without a refill request from a beneficiary. Items delivered without a valid, documented refill request will be denied as not reasonable and necessary.

Suppliers must not dispense a quantity of supplies exceeding a beneficiary's expected utilization. Suppliers must stay attuned to changed or atypical utilization patterns on the part of their clients. Suppliers must verify with the ordering physicians that any changed or atypical utilization is warranted. Regardless of utilization, a supplier must not dispense more than a 1-month quantity at a time.

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.

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 GA – Waiver of liability statement issued as required by payer policy, individual case GZ – Item or service expected to be denied as not reasonable and necessary

KX - Requirements specified in the medical policy have been met

HCPCS CODES:

J8501 APREPITANT, ORAL, 5 MG

J8540 DEXAMETHASONE, ORAL, 0.25 MG J8650 NABILONE, ORAL, 1 MG

Q0162 ONDANSETRON 1 MG, ORAL, FDA APPROVED PRESCRIPTION ANTI-EMETIC, FOR USE AS A COMPLETE THERAPEUTIC SUBSTITUTE FOR AN IV ANTI-EMETIC AT THE TIME OF CHEMOTHERAPY TREATMENT, NOT TO EXCEED A 48 HOUR DOSAGE REGIMEN

DIPHENHYDRAMINE HYDROCHLORIDE, 50 MG, ORAL, FDA APPROVED PRESCRIPTION ANTI-EMETIC, FOR Q0163 USE AS A COMPLETE THERAPEUTIC SUBSTITUTE FOR AN IV ANTI-EMETIC AT TIME OF CHEMOTHERAPY

TREATMENT NOT TO EXCEED A 48 HOUR DOSAGE REGIMEN

PROCHLORPERAZINE MALEATE, 5 MG, ORAL, FDA APPROVED PRESCRIPTION ANTI-EMETIC, FOR USE AS Q0164 A COMPLETE THERAPEUTIC SUBSTITUTE FOR AN IV ANTI-EMETIC AT THE TIME OF CHEMOTHERAPY

TREATMENT, NOT TO EXCEED A 48 HOUR DOSAGE REGIMEN

PROCHLORPERAZINE MALEATE, 10 MG, ORAL, FDA APPROVED PRESCRIPTION ANTI-EMETIC, FOR USE AS Q0165 A COMPLETE THERAPEUTIC SUBSTITUTE FOR AN IV ANTI-EMETIC AT THE TIME OF CHEMOTHERAPY

TREATMENT, NOT TO EXCEED A 48 HOUR DOSAGE REGIMEN

GRANISETRON HYDROCHLORIDE, 1 MG, ORAL, FDA APPROVED PRESCRIPTION ANTI-EMETIC, FOR USE Q0166 AS A COMPLETE THERAPEUTIC SUBSTITUTE FOR AN IV ANTI-EMETIC AT THE TIME OF CHEMOTHERAPY

TREATMENT, NOT TO EXCEED A 24 HOUR DOSAGE REGIMEN

DRONABINOL, 2.5 MG, ORAL, FDA APPROVED PRESCRIPTION ANTI-EMETIC, FOR USE AS A COMPLETE Q0167 THERAPEUTIC SUBSTITUTE FOR AN IV ANTI-EMETIC AT THE TIME OF CHEMOTHERAPY TREATMENT, NOT

TO EXCEED A 48 HOUR DOSAGE REGIMEN

DRONABINOL, 5 MG, ORAL, FDA APPROVED PRESCRIPTION ANTI-EMETIC, FOR USE AS A COMPLETE Q0168 THERAPEUTIC SUBSTITUTE FOR AN IV ANTI-EMETIC AT THE TIME OF CHEMOTHERAPY TREATMENT, NOT

TO EXCEED A 48 HOUR DOSAGE REGIMEN

PROMETHAZINE HYDROCHLORIDE, 12.5 MG, ORAL, FDA APPROVED PRESCRIPTION ANTI-EMETIC, FOR Q0169 USE AS A COMPLETE THERAPEUTIC SUBSTITUTE FOR AN IV ANTI-EMETIC AT THE TIME OF

CHEMOTHERAPY TREATMENT, NOT TO EXCEED A 48 HOUR DOSAGE REGIMEN

PROMETHAZINE HYDROCHLORIDE, 25 MG, ORAL, FDA APPROVED PRESCRIPTION ANTI-EMETIC, FOR USE Q0170 AS A COMPLETE THERAPEUTIC SUBSTITUTE FOR AN IV ANTI-EMETIC AT THE TIME OF CHEMOTHERAPY

TREATMENT, NOT TO EXCEED A 48 HOUR DOSAGE REGIMEN

CHLORPROMAZINE HYDROCHLORIDE, 10 MG, ORAL, FDA APPROVED PRESCRIPTION ANTI-EMETIC, FOR Q0171 USE AS A COMPLETE THERAPEUTIC SUBSTITUTE FOR AN IV ANTI-EMETIC AT THE TIME OF

CHEMOTHERAPY TREATMENT, NOT TO EXCEED A 48 HOUR DOSAGE REGIMEN

CHLORPROMAZINE HYDROCHLORIDE, 25 MG, ORAL, FDA APPROVED PRESCRIPTION ANTI-EMETIC, FOR Q0172 USE AS A COMPLETE THERAPEUTIC SUBSTITUTE FOR AN IV ANTI-EMETIC AT THE TIME OF

CHEMOTHERAPY TREATMENT, NOT TO EXCEED A 48 HOUR DOSAGE REGIMEN

TRIMETHOBENZAMIDE HYDROCHLORIDE, 250 MG, ORAL, FDA APPROVED PRESCRIPTION ANTI-EMETIC, Q0173 FOR USE AS A COMPLETE THERAPEUTIC SUBSTITUTE FOR AN IV ANTI-EMETIC AT THE TIME OF

CHEMOTHERAPY TREATMENT, NOT TO EXCEED A 48 HOUR DOSAGE REGIMEN

THIETHYLPERAZINE MALEATE, 10 MG, ORAL, FDA APPROVED PRESCRIPTION ANTI-EMETIC, FOR USE AS Q0174 A COMPLETE THERAPEUTIC SUBSTITUTE FOR AN IV ANTI-EMETIC AT THE TIME OF CHEMOTHERAPY

TREATMENT, NOT TO EXCEED A 48 HOUR DOSAGE REGIMEN

PERPHENAZINE, 4 MG, ORAL, FDA APPROVED PRESCRIPTION ANTI-EMETIC, FOR USE AS A COMPLETE Q0175 THERAPEUTIC SUBSTITUTE FOR AN IV ANTI-EMETIC AT THE TIME OF CHEMOTHERAPY TREATMENT, NOT

TO EXCEED A 48 HOUR DOSAGE REGIMEN

PERPHENAZINE, 8MG, ORAL, FDA APPROVED PRESCRIPTION ANTI-EMETIC, FOR USE AS A COMPLETE Q0176 THERAPEUTIC SUBSTITUTE FOR AN IV ANTI-EMETIC AT THE TIME OF CHEMOTHERAPY TREATMENT, NOT

TO EXCEED A 48 HOUR DOSAGE REGIMEN

HYDROXYZINE PAMOATE, 25 MG, ORAL, FDA APPROVED PRESCRIPTION ANTI-EMETIC, FOR USE AS A Q0177 COMPLETE THERAPEUTIC SUBSTITUTE FOR AN IV ANTI-EMETIC AT THE TIME OF CHEMOTHERAPY

TREATMENT, NOT TO EXCEED A 48 HOUR DOSAGE REGIMEN

HYDROXYZINE PAMOATE, 50 MG, ORAL, FDA APPROVED PRESCRIPTION ANTI-EMETIC, FOR USE AS A Q0178 COMPLETE THERAPEUTIC SUBSTITUTE FOR AN IV ANTI-EMETIC AT THE TIME OF CHEMOTHERAPY

TREATMENT, NOT TO EXCEED A 48 HOUR DOSAGE REGIMEN

DOLASETRON MESYLATE, 100 MG, ORAL, FDA APPROVED PRESCRIPTION ANTI-EMETIC, FOR USE AS A Q0180 COMPLETE THERAPEUTIC SUBSTITUTE FOR AN IV ANTI-EMETIC AT THE TIME OF CHEMOTHERAPY

TREATMENT, NOT TO EXCEED A 24 HOUR DOSAGE REGIMEN

UNSPECIFIED ORAL DOSAGE FORM, FDA APPROVED PRESCRIPTION ANTI-EMETIC, FOR USE AS A Q0181 COMPLETE THERAPEUTIC SUBSTITUTE FOR A IV ANTI-EMETIC AT THE TIME OF CHEMOTHERAPY

TREATMENT, NOT TO EXCEED A 48 HOUR DOSAGE REGIMEN

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.

Printed on 1/26/2013. Page 4 of 13

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 beneficiary's medical records will reflect the need for the care provided. The beneficiary'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.

PRESCRIPTION (ORDER) REQUIREMENTS

GENERAL (PIM 5.2.1)

All items billed to Medicare require a prescription. 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 dispensed and/or billed that do not meet these prescription requirements and those below must be submitted with an EY modifier added to each affected HCPCS code.

DISPENSING ORDERS (PIM 5.2.2)

Equipment and supplies may be delivered upon receipt of a dispensing order except for those items that require a written order prior to delivery. A dispensing order may be verbal or written. The supplier must keep a record of the dispensing order on file. It must contain:

• Description of the item

• Beneficiary's name

• Prescribing Physician's name

• Date of the order and the start date, if the start date is different from the date of the order

• Physician signature (if a written order) or supplier signature (if verbal order)

For the “Date of the order” described above, use the date the supplier is contacted by the physician (for verbal orders) or the date entered by the physician (for written dispensing orders).

Signature and date stamps are not allowed. Signatures must comply with the CMS signature requirements outlined in PIM 3.3.2.4.

The dispensing order must be available upon request.

For items that are provided based on a dispensing order, the supplier must obtain a detailed written order before submitting a claim.

DETAILED WRITTEN ORDERS (PIM 5.2.3)

A detailed written order (DWO) is required before billing. Someone other than the ordering physician may produce the DWO. However, the ordering physician must review the content and sign and date the document. It must contain:

• Beneficiary's name

• Physician's name

• Date of the order and the start date, if start date is different from the date of the order

• Detailed description of the item(s) (see below for specific requirements for selected items)

• Physician signature and signature date

For items provided on a periodic basis, including drugs, the written order must include:

• Item(s) to be dispensed

• Dosage or concentration, if applicable

• Route of Administration

• Frequency of use

• Duration of infusion, if applicable

• Quantity to be dispensed

• Number of refills

For the “Date of the order” described above, use the date the supplier is contacted by the physician (for verbal orders) or the date entered by the physician (for written dispensing orders).

Frequency of use information on orders must contain detailed instructions for use and specific amounts to be dispensed. Reimbursement shall be based on the specific utilization amount only. Orders that only state “PRN” or “as needed” utilization estimates for replacement frequency, use, or consumption are not acceptable. (PIM 5.9)

The detailed description in the written order may be either a narrative description or a brand name/model number.

Signature and date stamps are not allowed. Signatures must comply with the CMS signature requirements outlined in PIM 3.3.2.4.

The DWO must be available upon request.

A prescription is not considered as part of the medical record. Medical information intended to demonstrate compliance with coverage criteria may be included on the prescription but must be corroborated by information contained in the medical record.

MEDICAL RECORD INFORMATION

GENERAL (PIM 5.7 -5.9)

The Indications and Limitations of Coverage and/or Medical Necessity section of this LCD contains numerous reasonable and necessary (R&N) requirements. The Nonmedical Necessity Coverage and Payment Rules section of the related Policy Article contains numerous non-reasonable and necessary, benefit category and statutory requirements that must be met in order for payment to be justified. Suppliers are reminded that:

• Supplier-produced records, even if signed by the ordering physician, and attestation letters (e.g. letters of medical necessity) are deemed not to be part of a medical record for Medicare payment purposes.

• Templates and forms, including CMS Certificates of Medical Necessity, are subject to corroboration with information in the medical record.

Information contained directly in the contemporaneous medical record is the source required to justify payment except as noted elsewhere for prescriptions and CMNs. The medical record is not limited to physician’s office records but may include records from hospitals, nursing facilities, home health agencies, other healthcare professionals, etc. (not all-inclusive). Records from suppliers or healthcare professionals with a financial interest in the claim outcome are not considered sufficient by themselves for the purpose of determining that an item is reasonable and necessary.

CONTINUED USE

Continued use describes the ongoing utilization of supplies or a rental item by a beneficiary.

Suppliers are responsible for monitoring utilization of DMEPOS rental items and supplies. No monitoring of purchased items or capped rental items that have converted to a purchase is required. Suppliers must discontinue billing Medicare when rental items or ongoing supply items are no longer being used by the beneficiary.

Beneficiary medical records or supplier records may be used to confirm that a DMEPOS item continues to be used by the beneficiary. Any of the following may serve as documentation that an item submitted for reimbursement continues to be used by the beneficiary:

1. Timely documentation in the beneficiary's medical record showing usage of the item, related option/accessories and supplies.

2. Supplier records documenting the request for refill/replacement of supplies in compliance with the Refill Documentation Requirements This is deemed to be sufficient to document continued use for the base item, as well.

3. Supplier records documenting beneficiary confirmation of continued use of a rental item

Timely documentation is defined as a record in the preceding 12 months unless otherwise specified elsewhere in this policy.

CONTINUED MEDICAL NEED

For all DMEPOS items, the initial justification for medical need is established at the time the item(s) is first ordered; therefore, beneficiary medical records demonstrating that the item is reasonable and necessary are created just prior to, or at the time of, the creation of the initial prescription. For purchased items, initial months of a rental item or for initial months of ongoing supplies or drugs, information justifying reimbursement will come from this initial time period. Entries in the beneficiary’s medical record must have been created prior to, or at the time of, the initial DOS to establish whether the initial reimbursement was justified based upon the applicable coverage policy.

For ongoing supplies and rental DME items, in addition to information described above that justifies the initial provision of the item(s) and/or supplies, there must be information in the beneficiary’s medical record to support that the item continues to be used by the beneficiary and remains reasonable and necessary. Information used to justify continued medical need must be timely for the DOS under review. Any of the following may serve as documentation justifying continued medical need:

A recent order by the treating physician for refills

A recent change in prescription

A properly completed CMN or DIF with an appropriate length of need specified

Timely documentation in the beneficiary's medical record showing usage of the item.

Timely documentation is defined as a record in the preceding 12 months unless otherwise specified elsewhere in the policy.

REFILL DOCUMENTATION (PIM 5.2.5-6)

A routine refill prescription is not needed. A new prescription is needed when:

• There is a change of supplier

• There is a change in the item(s), frequency of use, or amount prescribed

• There is a change in the length of need or a previously established length of need expires

• State law requires a prescription renewal

For items that the beneficiary obtains in-person at a retail store, the signed delivery slip or a copy of the itemized sales receipt is sufficient documentation of a request for refill.

For items that are delivered to the beneficiary, documentation of a request for refill must be either a written document received from the beneficiary or a contemporaneous written record of a phone conversation/contact between the supplier and beneficiary. The refill request must occur and be documented before shipment. A retrospective attestation statement by the supplier or beneficiary is not sufficient. The refill record must include:

• Beneficiary's name or authorized representative if different than the beneficiary

• A description of each item that is being requested

• Date of refill request

• Information documenting that the beneficiary's remaining supply is approaching exhaustion by the expected delivery date

PROOF OF DELIVERY (PIM 4.26, 5.8)

Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are required to maintain POD documentation in their files. For medical review purposes, POD serves to assist in determining correct coding and billing information for claims submitted for Medicare reimbursement. Regardless of the method of delivery, the contractor must be able to determine from delivery documentation that the supplier properly coded the item(s), that the item(s) delivered are the same item(s) submitted for Medicare reimbursement and that the item(s) are intended for, and received by, a specific Medicare beneficiary.

Suppliers, their employees, or anyone else having a financial interest in the delivery of the item are prohibited from signing and accepting an item on behalf of a beneficiary (i.e., acting as a designee on behalf of the beneficiary). The signature and date the beneficiary or designee accepted delivery must be legible.

For the purpose of the delivery methods noted below, designee is defined as "Any person who can sign and accept the delivery of durable medical equipment on behalf of the beneficiary."

Proof of delivery documentation must be available to the Medicare contractor on request. All services that do not have appropriate proof of delivery from the supplier will be denied and overpayments will be requested. Suppliers who consistently fail to provide documentation to support their services may be referred to the OIG for imposition of Civil Monetary Penalties or other administrative sanctions.

Suppliers are required to maintain POD documentation in their files. There are three methods of delivery:

1. Delivery directly to the beneficiary or authorized representative

2. Delivery via shipping or delivery service

3. Delivery of items to a nursing facility on behalf of the beneficiary

Method 1—Direct Delivery to the Beneficiary by the Supplier

Suppliers may deliver directly to the beneficiary or the designee. In this case, POD to a beneficiary must be a signed and dated delivery slip. The POD record must include:

• Beneficiary's name

• Delivery address

• Sufficiently detailed description to identify the item(s) being delivered (e.g., brand name, serial number, narrative description)

• Quantity delivered

• Date delivered

• Beneficiary (or designee) signature and date of signature

The date of signature on the delivery slip must be the date that the DMEPOS item was received by the beneficiary or designee. In instances where the supplies are delivered directly by the supplier, the date the beneficiary received the DMEPOS supply must be the date of service on the claim.

Method 2—Delivery via Shipping or Delivery Service Directly to a Beneficiary

If the supplier utilizes a shipping service or mail order, the POD documentation must be a complete record tracking the item(s) from the DMEPOS supplier to the beneficiary. An example of acceptable proof of delivery would include both the supplier's own detailed shipping invoice and the delivery service's tracking information. The supplier's record must be linked to the delivery service record by some clear method like the delivery service's package identification number or supplier's invoice number for the package sent to the beneficiary. The POD record must include:

• Beneficiary's name

• Delivery address

• Delivery service's package identification number, supplier invoice number or alternative method that links the supplier's delivery documents with the delivery service's records.

• Sufficiently detailed description to identify the item(s) being delivered (e.g., brand name, serial number, narrative description)

• Quantity delivered

• Date delivered

• Evidence of delivery

If a supplier utilizes a shipping service or mail order, suppliers must use the shipping date as the date of service on the claim.

Suppliers may also utilize a return postage-paid delivery invoice from the beneficiary or designee as a POD. This type of POD record must contain the information specified above.

Method 3—Delivery to Nursing Facility on Behalf of a Beneficiary

When a supplier delivers items directly to a nursing facility, the documentation described for Method 1 (see above) is required.

When a delivery service or mail order is used to deliver the item to a nursing facility, the documentation described for Method 2 (see above) is required.

Regardless the method of delivery, for those beneficiaries that are residents of a nursing facility, information from the nursing facility showing that the item(s) delivered for the beneficiary's use were actually provided to and used by the beneficiary must be available upon request.

POLICY SPECIFIC DOCUMENTATION REQUIREMENTS

The supplier must enter an ICD-9 diagnosis code corresponding to the beneficiary's cancer diagnosis on each claim.

The oral antiemetic 3-drug combination of aprepitant (J8501), a 5-HT3 antagonist (Q0162, Q0166, Q0180), and dexamethasone (J8540) should be submitted on the same claim.

Claims for code Q0181 must be accompanied by the name of the drug, the manufacturer, the dosage strength dispensed, the number of tablets and frequency of administration during the covered time period (24-48 hours) as specified on the order. This information should be entered in the narrative field of an electronic claim.

KX, GA AND GZ MODIFIERS

If aprepitant (J8501) and dexamethasone (J8540) are used in conjunction with one of the anticancer chemotherapeutic agents listed in the Indications and Limitations of Coverage section of this policy, a KX modifier must be added to each code.

If aprepitant and dexamethasone are not used in conjunction with one of the anticancer chemotherapeutic agents listed in the Indications and Limitations of Coverage section of this policy the GA or GZ modifier must be added to a claim line for aprepitant or dexamethasone. When there is an expectation of a denial as not reasonable and necessary, suppliers must enter the GA modifier on the claim line if they have obtained a properly executed Advance Beneficiary Notice (ABN) or the GZ modifier if they have not obtained a valid ABN.

Claim lines billed without a KX, GA, or GZ modifier will be rejected as missing information.

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

Appendices PIM citations above denote references to CMS Program Integrity Manual, Internet Only Manual 100-8.

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

Sources of Information and Basis for Decision

Reserved for future use. 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 010

Revision History Explanation Revision History Effective Date: 01/01/2012 Documentation Requirements:

Changed: HCPCS Codes: Q0179 to Q0162

Revision History Effective Date: 01/01/2012

INDICATIONS AND LIMITATIONS OF COVERAGE AND MEDICAL NECESSITY:

Revised: Order requirement language to specify a “detailed written order” Added: Refill requirements per PIM 5.2.6 (effective 08/02/2011 per CR7452) HCPCS CODES:

Added: Q0162

DOCUMENTATION REQUIREMENTS:

(Note: The effective date above is not applicable to this section. These revised and added requirements are existing Medicare requirements which are now included in the LCD for easy reference)

Revised: Prescription requirements

Added: Refill requirements, general medical record information requirements and proof of delivery requirements

11/21/2011 - The following CPT/HCPCS codes were deleted: Q0179 was deleted from Group 1

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.

Revision Effective Date: 01/01/2011 INDICATIONS AND LIMITATIONS OF COVERAGE:

Revised: Preamble language HCPCS CODES AND MODIFIERS:

Revised: GA modifier

Revision Effective Date: 12/01/2009 HCPCS CODES AND MODIFIERS:

Added: GA and GZ modifiers Revised: KX modifier DOCUMENTATION REQUIREMENTS:

Added: Instructions for use of the GA and GZ modifiers

11/09/2008 - The description for CPT/HCPCS code Q0179 was changed in group 1

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.

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).

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

Revised: DMERC reference to DME MAC HCPCS CODES AND MODIFIERS:

Added: J8650

DOCUMENTATION REQUIREMENTS:

Removed: DMERC references

Revision Effective Date: 03/01/2006 (June 2006 Publication) DOCUMENTATION REQUIREMENTS:

Added: J8540 to KX requirement

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).

Printed on 1/26/2013. Page 11 of 13

Revision Effective Date: 01/01/2006 INDICATIONS AND LIMITATIONS OF COVERAGE:

Added: J8540 Deleted: Q0181

HCPCS CODES AND MODIFIERS: Added: J8540, Q0511, Q0512

Deleted: G0370

DOCUMENTATION REQUIREMENTS:

Added: J8540 Deleted: Q0181

Revised: Q0181 requirements

Revision Effective Date: 04/04/2005 INDICATIONS AND LIMITATIONS OF COVERAGE:

Added coverage criteria for aprepitant and dexamethasone HCPCS CODES AND MODIFIERS:

Added KX modifier DOCUMENTATION REQUIREMENTS:

Added KX modifier requirement and other claims submission requirements for aprepitant.

Revision Effective Date: 04/01/2005 LMRP converted to LCD and Policy Article HCPCS CODES AND MODIFIERS:

Added: G0370, J8501

Revision Effective Date: 07/01/2003 INDICATIONS AND LIMITATION OF COVERAGE:

Corrects reference to immunosuppressive drug which should be oral antiemetic drugs.

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.

04/01/2001 - The revision language reflects a change in jurisdiction for claim submission by physicians who are also DMEPOS suppliers. In addition, the policy incorporates instructions from the Centers for Medicare & Medicaid Services (CMS), formerly the Health Care Financing Administration, regarding entities qualified to dispense and bill for Medicare-covered drugs.

Reason for Change Typographical Correction