Oral Anticancer Drugs - Policy Article

**NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES**  
  
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. Information provided in this policy article relates
to determinations other than those based on Social Security Act 1862(a)(1)(A)
provisions (i.e. "reasonable and necessary").  
  
Oral anticancer drugs are covered under the oral anticancer drug benefit
[Social Security Act 1861(s)(2)(Q)]. In order for a beneficiary's oral
anticancer drugs to be eligible for reimbursement, the reasonable and
necessary (R&N) requirements set out in the related Local Coverage
Determination must be met. In addition, there are specific statutory payment
policy requirements, discussed below, that also must be met.  
  
For an item to be covered by Medicare, a written signed and dated order must
be received by the supplier before a claim is submitted. If the supplier bills
for an item addressed in this policy without first receiving the completed
order, the item will be denied as non-covered.  
  
  
 _Oral Anticancer Drugs_  
  
For an oral anticancer drug to be covered, all of the following criteria (1-4)
must be met (CMS Claims Processing Manual, Internet-Only Manual, CMS Pub.
100-4, Chapter 17, Section 80.1).  
  

  1. It is a drug or biological that has been approved by the Food and Drug Administration (FDA), and  
  

  2. It has the same active ingredients as a non-self-administrable anticancer chemotherapeutic drug or biological that is covered when furnished incident to a practitioner's service. The oral anticancer drug and the non-self-administrable drug must have the same chemical/generic name as indicated by the FDA's Approved Drug Products (Orange Book), Physician's Desk Reference (PDR), or an authoritative drug compendium, or it is a prodrug which, when ingested, is metabolized into the same active ingredient which is found in the non-self-administrable form of the drug, and  
  

  3. It is used for the same anticancer chemotherapeutic indications, including unlabeled or "off label" uses, as the non-self-administrable form of the drug, and   
  

  4. It is prescribed by a practitioner licensed under state law to prescribe such drugs as anticancer chemotherapeutic agents.

A drug that is not available in an injectable form does not meet criterion 2.
If an oral anticancer drug is used for immunosuppression (rather than the
treatment of cancer), criterion 3 is not met, and the drug cannot be covered
under the oral anticancer drug benefit. (If the drug is used for
immunosuppression following organ transplant, refer to the Immunosuppressive
Drugs policy.)  
  
If criteria 1-4 are not met, the drug will be denied as non-covered.  
  
A claim denied for the reason that a diagnosis does not fall in the section
below in this Policy Article titled "ICD-10 Codes that Support Medical
Necessity" will receive a statutory denial as non-covered, but may be covered
at appeal if and only if it can be shown to be allowed under CMS IOM 100-02,
Chapter 15, Section 50 - Drugs and Biologicals, and under the Social Security
Act, Sec.1861(s)(Q).  
  
The quantity of oral anticancer drugs that is dispensed should be limited to a
30-day supply. Prescriptions may be refillable.  
  
 _Antiemetic Drugs Used With Oral Anticancer Drugs_  
  
A self-administered antiemetic drug billed with code J8498 or J8597 is covered
if all of the following criteria are met:  
  

  1. It is used in conjunction with a covered oral anticancer drug, and  
  

  2. It is likely that administration of the covered oral anticancer drug will induce emesis if the antiemetic drug is not administered, and  
  

  3. The antiemetic drug is administered within 2 hours before the covered oral anticancer drug is administered.

Antiemetic drugs are covered under the oral anticancer drug benefit for the
sole purpose of allowing the absorption of the covered oral anticancer drug.
Therefore, coverage is limited to doses of antiemetic drugs, which are
administered during the two hours before administration of the covered oral
anticancer drug. Doses of antiemetic drugs administered after the
administration of the oral anticancer drug (e.g., to treat nausea or vomiting
which is caused by the oral anticancer drug or other etiology) are non-
covered.  
  
If all of the criteria are not met, the antiemetic drug will be denied as non-
covered.  
  
For information on the coverage of oral antiemetic drugs when they are used as
a full replacement for intravenous antiemetic drugs used in conjunction with
intravenous cancer chemotherapeutic regimens, refer to the Oral Antiemetic
Drugs (Replacement for Intravenous Antiemetics) policy.  
  
 _Supply Fee_  
  
One unit of service of supply fee code Q0511 is covered for the first covered
oral anticancer drug that is dispensed in a 30-day period. If covered drugs
are dispensed by more than one pharmacy during a 30 day period, one unit of
Q0511 is covered for each pharmacy. One unit of service of supply fee code
Q0512 is covered for each subsequent covered oral anticancer drug that is
dispensed in that 30-day period. If two dosage strengths of the same drug are
dispensed on the same day, one unit of service of the appropriate supply fee
is payable for each one. If more than one unit of service of code Q0511 is
billed per 30 days by a single pharmacy, the excess units of service will be
denied as incorrect coding. If the billed units of service of Q0511 or Q0512
exceed the number of drugs on the claim, the excess units will be denied as
not separately payable.  
  
Supply fees are eligible for coverage only for drugs that are covered under
this LCD. If the drug on the claim is denied as non-covered, the supply fee
will be denied as non-covered.  
  
The supply fee code must be billed on the same claim as the drug(s). If it is
not, the supply fee will be denied as incorrect billing.  
  
J8498 is not eligible for payment of a supply fee.



**REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed.
Reg Vol 217)**

Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a
Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the
DME MACs provide a list of the specified codes, which is periodically updated.
The required Face-to-Face Encounter and Written Order Prior to Delivery List
is available [here](https://www.cms.gov/Research-Statistics-Data-and-
Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Medical-
Review/FacetoFaceEncounterRequirementforCertainDurableMedicalEquipment).

Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol
217) that do not meet the face-to-face encounter and WOPD requirements
specified in the LCD-related Standard Documentation Requirements Article
(A55426) will be denied as not reasonable and necessary.

If a supplier delivers an item prior to receipt of a WOPD, it will be denied
as not reasonable and necessary. If the WOPD is not obtained prior to
delivery, payment will not be made for that item even if a WOPD is
subsequently obtained by the supplier. If a similar item is subsequently
provided by an unrelated supplier who has obtained a WOPD, it will be eligible
for coverage.

  
  
**POLICY SPECIFIC DOCUMENTATION REQUIREMENTS**  
  
In addition to policy specific documentation requirements, there are general
documentation requirements that are applicable to all DMEPOS policies. These
general requirements are located in the DOCUMENTATION REQUIREMENTS section of
the LCD.  
  
Refer to the LCD-related Standard Documentation Requirements article, located
at the bottom of this Policy Article under the Related Local Coverage
Documents section for additional information regarding GENERAL DOCUMENTATION
REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed
below.  
  
The ICD-10 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
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 must be entered in the
narrative field of an electronic claim.  
  
  
  
 **CODING GUIDELINES**  
  
For the instructions below that apply to J codes, when claims are billed in
NCPDP format using NDC numbers, different instructions may apply. Refer to the
NCPDP Companion Document available through the CMS web site.  
  
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.  
  
For all NDC numbers, 1 unit of service = 1 tablet or 1 capsule. Under the
Metric Decimal Quantity and the Billing Unit Standard for NCPDP, solid oral
dosage forms (tablets, capsules, etc.) are billed as "each" i.e., 1 unit of
service = 1 tablet or 1 capsule each. Suppliers must use the NDC that matches
the product dispensed. HCPCS J codes for these drugs must not be used when
billing for these drugs.  
  
For codes J8498 and J8597, 1 unit of service = 1 mg. Under no other
circumstances should the number of grams, milligrams, etc. be used for the UOS
of drugs addressed in this policy.  
  
National Drugs Codes (NDCs) may be billed only when the drug is used as an
oral anticancer drug. If cyclophosphamide or methotrexate are prescribed as an
oral immunosuppressive drug following an organ transplant, code J8530 or J8610
respectively must be used. (Refer to the Immunosuppressive Drugs policy for
additional information.) If, for example, cyclophosphamide or methotrexate is
prescribed as an oral immunosuppressive drug for other conditions (e.g.,
lupus, rheumatoid arthritis, etc.), a claim should not be submitted to
Medicare (unless requested by the beneficiary; and in which case it would be
submitted with a GY modifier) because there is no statutory benefit for oral
immunosuppressive drugs in these conditions.  
  
Code J8498 or J8597 may be billed only when the antiemetic drug is used in
conjunction with a covered oral anticancer drug. Suppliers may bill only for
quantities of antiemetic drugs that are to be used within 2 hours before the
covered oral anticancer drug. Refer to the Oral Antiemetic Drugs (Replacement
for Intravenous Antiemetics) policy for information on billing oral
antiemetics used in conjunction with intravenous cancer chemotherapeutic
regimens.  
  
A list of valid NDC numbers called the "NDC/HCPCS Crosswalk" for covered oral
anticancer drugs can be found on the Pricing, Data Analysis and Coding (PDAC)
Contractor web site. Until a new NDC number is added to the list, suppliers
must submit claims using code J8999.  
  
Oral anticancer drugs which are not covered under the oral anticancer drug
benefit (i.e., those that are not specifically listed in this policy) must be
billed using code A9270 (noncovered item or service) if the supplier chooses
to submit a claim.  
  
Suppliers should contact the PDAC Contractor for guidance on the correct
coding of these items.