This LCD explains the coverage criteria for selected drugs and biologicals. The agents discussed in this LCD in no way constitute a complete list of drugs and biologicals covered by Medicare. Contractors implement LCDs to apply the standard of reasonable and necessary in situations not covered by specific national policy. In particular, coverage criteria for drugs used to treat cancer, immune deficiency syndromes, as well as acute and chronic treatments of eye disease are explained in separate LCDs and are not included in this LCD. This LCD has been promulgated to establish the clinical conditions for which the included drugs are considered to be safe and effective and otherwise medically reasonable and necessary and, thus, covered by Medicare.

Note: This LCD and the related Article do NOT describe drug and biological coverage under the Medicare Part D benefit.

Medicare Benefit Policy Manual, Pub. 100-02, Chapter 15, Section 50, describes national policy regarding Medicare guidelines for coverage of drugs and biologicals. The pertinent national policy can be referenced in the attached Article.

Effective for dates of service on or after January 1, 2008, all claims for administration of Part B anti-anemia drugsother than Erythropoiesis Stimulating Agents (ESAs) used in the treatment of cancer that are not self-administered shall require the most recent Hematocrit (HCT) and/or Hemoglobin (Hgb). This requirement will be implemented for claims received on or after April 7, 2008. Refer to Claims Processing Manual Pub. 100-04, Chapter 17, Section 80.8, for further coverage/coding guidance. See the limited coverage below for codes J1750 (use for services provided on or after January 1, 2009; use J1751 and J1752 for services provided January 1 through March 31, 2008; use Q4098 for services provided April 1 through December 31, 2008), J1756 and J2916.

Medicare covers zoledronic acid for certain people with osteoporosis who are unable to take an oral bisphosphonate because of a medical or surgical condition, such as those people:

The person must have osteoporosis as evidenced by a spine, hip or pelvis Bone Mineral Density (BMD) T-score ≤ -2.5 or a low-trauma hip fracture or a 10-year all major osteoporosis-related fracture probability of ≥ 20 percent based on the U.S.-adapted World Health Organization (WHO) absolute fracture risk model (FRAX^®). When intravenous zoledronic acid is used, the medical record must clearly reflect that the parenteral agent, rather than the oral agent, is the medically prudent choice.

Medicare expects that most patients with iron deficiency will not require parenteral iron supplementation. Medicare coverage for parenteral iron products is limited to parenteral iron administered to iron-deficient patients in whom oral and/or enteral (if applicable) iron or enteral iron therapy has been demonstrated to have been ineffective, or in other clinical circumstances (such as the need for large iron doses not possible via oral/enteral administration or the need for more rapid repletion of iron stores than possible via oral/enteral administration in patients with severe symptomatic iron deficiency).

Drugs provided during acute inpatient stays and qualified skilled nursing facility stays are generally covered if Medicare requirements are met. Coverage of drugs and biologicals under Part B is generally limited to the type of drugs that cannot be self-administered and meet “incident to” requirements. One requirement for coverage of drugs and biologicals is that the drug must be of a type that is usually not self-administered. Medicare Benefit Policy Manual, Pub. 100-02, Chapter 15, Section 50.2, gives guidance for determining whether a drug or biological is considered self-administered, or access our Web site at http://www.trailblazerhealth.com/Medicare.aspx, select “Specialty Services,” “Drugs-Biologicals” and then “Self-Administered Drugs.”

Immunizations are not covered unless the medication is directly related to the treatment of an injury or there is direct exposure to a disease or condition. Preventive immunizations are specifically not covered with the exception of influenza, pneumococcal and hepatitis B vaccines. See national reference in attached article and in the “Immunizations – 4I-83” LCD.

Medicare provides payment for the discarded drug/biological remaining in a single-use drug product after administering what is reasonable and necessary for the patient’s condition. If the physician has made good faith efforts to minimize the unused portion of the drug/biological in how patients are scheduled and how he ordered, accepted, stored and used the drug, and made good faith efforts to minimize the unused portion of the drug in how it is supplied, the program will cover the amount of drug discarded along with the amount administered. Documentation requirements are given below. Coding and billing instructions can be referenced in attached article. Refer to national policy: Medicare Claims Processing Manual – Pub. 100-04, Chapter 17, Section 40.

Note: The JW modifier is not used on claims for drugs or biologicals provided under the Competitive Acquisition Program (CAP). Reference to national policy: Medicare Claims Processing Manual, Pub. 100-04, Chapter 17, Section 100.2.9.

Certain unusual uses of certain drugs may be covered on an “LCD Individual Consideration” basis. Such situations are described in the notes under the limited coverage for each drug. Instructions on submitting a redetermination for “LCD Individual Consideration” are given in the attached article.

12X, 13X, 18X, 21X, 22X, 23X, 28X, 71X, 72X, 73X, 75X, 77X, 83X, 85X

Note: TrailBlazer has identified the Bill Type and Revenue Codes applicable for use with the CPT/HCPCS codes included in this LCD. Providers are reminded that not all CPT/HCPCS codes listed can be billed with all Bill Type and/or Revenue Codes listed. CPT/HCPCS codes are required to be billed with specific Bill Type and Revenue Codes. Providers are encouraged to refer to the CMS Internet-Only Manual (IOM) Pub. 100-04, Claims Processing Manual, for further guidance.

025X, 0636

The CPT/HCPCS codes included in this LCD will be subjected to “procedure to diagnosis” editing. The following lists include only those diagnoses for which the identified CPT/HCPCS procedures are covered. If a covered diagnosis is not on the claim, the edit will automatically deny the service as not medically necessary.

Note: The limited coverage for HCPCS code J0894 (injection, decitabine, 1 mg) may be found in the TrailBlazer LCD, “Drugs and Biologicals – Chemotherapeutic – 4I-92AB.

Note: The limited coverage for HCPCS codes for injection, bevacizumab – J9035 (injection, bevacizumab, 10 mg when used for cancer treatment and when treating eye disease) and C9257 (injection, bevacizumab, 0.25 mg) (OPPS and ASC) may be found in the TrailBlazer LCD, “Drugs and Biologicals – Chemotherapeutic – 4I-92AB.”

Medicare is establishing the following limited coverage for HCPCS code J0129:

Medicare is establishing the following limited coverage for HCPCS code J0150:

Medicare is establishing the following limited coverage for HCPCS code J1212:

Medicare is establishing the following limited coverage for HCPCS code J1260:

Medicare is establishing the following limited coverage for HCPCS code J1300:

Medicare is establishing the following limited coverage for HCPCS code J1450:

Note: Medicare expects that most patients with candidal infections limited to mucosal surfaces (including the esophagus) will not require parenteral anti-fungal medications. Clinical necessity for parenteral antifungal medications for such patients must be clearly documented in the patient’s medical record.

Medicare is establishing the following limited coverage for HCPCS code J1645:

Medicare is establishing the following limited coverage for HCPCS code J1650:

Medicare is establishing the following limited coverage for HCPCS code J1652:

Medicare is establishing the following limited coverage for HCPCS code J1655:

Medicare is establishing the following limited coverage for CPT/HCPCS code J1745:

Note: Individual consideration for J1745 will be given if the infliximab is used to treat refractory pyoderma gangrenosum (ICD-9-CM diagnosis code 686.01) and documentation received by Medicare demonstrates that all available, medically appropriate, conventional treatments have been utilized and failed to control the disease. An adequate trial for each treatment must be documented.

Coverage of parenteral iron preparations, HCPCS codes J1750, J1756, J2916 and J3490 (when used to report ferumoxytol)/Q0138, Q0139 (effective January 1, 2010): Medicare expects that most patients with iron deficiency will not require parenteral iron supplementation. Medicare will cover parenteral iron preparations, but coverage is limited to those iron-deficient patients in whom oral iron or enteral iron therapy has been demonstrated to have been ineffective, or in other clinical circumstances (such as the need for larger iron doses not possible to provide through oral administration or the need for rapid repletion of iron stores in patients with severe symptomatic iron deficiency) in which oral or enteral iron therapy is otherwise unacceptable.

See “Coding Guidelines” in associated LCD article for further parenteral iron preparation coding requirements.

Medicare is establishing the following limited coverage for HCPCS code J1750:

Medicare is establishing the following limited coverage for HCPCS code J1756 (requires dual diagnosis):

Medicare is establishing the following limited coverage for HCPCS code J2916 (requires dual diagnosis):

Medicare is establishing the following limited coverage for HCPCS code J3490 (when used to identify ferumoxytol)for claims with dates of service on or after June 30, 2009, to December 31, 2009, and HCPCS codes Q0138 and Q0139 for claims with dates of service on or after January 1, 2010 (requires dual diagnosis):

Medicare is establishing the following limited coverage for HCPCS code J1930:

Medicare is establishing the following limited coverage for HCPCS code J2248:

Medicare is establishing the following limited coverage for HCPCS code J2323:

Medicare is establishing the following limited coverage for HCPCS code J2353:

Medicare is establishing the following limited coverage for HCPCS code J2355:

Medicare is establishing the following limited coverage for HCPCS code J2430:

Note: LCD Individual Consideration for J2430 will be given if the IV pamidronate is being used to treat osteoporosis or osteopenia and documentation is available to document that all available (as medically appropriate) oral agents have been tried and have caused such side effects that the drugs were discontinued. An adequate trial (not less than one month) for each drug must be demonstrated. In this case, side effects (e.g., esophagitis, nausea, etc.) and associated attempts at their amelioration must be properly documented.

Note: The limited coverage for HCPCS code J9035 (injection, bevacizumab, 10 mg) may be found in the TrailBlazer LCD, “Drugs and Biologicals – Chemotherapeutic – 4I-92AB.”

Medicare is establishing the following limited coverage for HCPCS code J2778:

Medicare is establishing the following limited coverage for HCPCS code J2796:

Medicare is establishing the following limited coverage for HCPCS code J2503:

Medicare is establishing the following limited coverage for HCPCS code J3487:

Medicare is establishing the following limited coverage for HCPCS code J3488:

Medicare is establishing the following dual diagnosis limited coverage for HCPCS code J3488 when used in the treatment of osteoporosis:

The following are secondary (dual) diagnoses to be used with 733.01 or 733.09 (primary diagnosis) to meet limited coverage for HCPCS code J3488

Medicare is establishing the following limited coverage for HCPCS code Q3025:

Note: Code Q3025 is covered only when administered under the direct supervision of a physician.

Note: Providers should continue to submit ICD-9-CM diagnosis codes without decimals on their claim forms and electronic claims.

N/A

N/A

All diagnoses not listed in the “ICD-9-CM Codes That Support Medical Necessity” section of this LCD.

Documentation supporting medical necessity should be legible, maintained in the patient’s medical record and made available to Medicare upon request.

When parenteral iron preparations are reported for Medicare payment, the medical record must clearly reflect that oral or enteral (if applicable) administration was insufficient or inadequate. Underlying clinical conditions necessitating parenteral administration of iron and reported diagnoses must be clearly demonstrated in the record.

When intravenous zoledronic acid is used, the medical record must clearly reflect that the parenteral agent, rather than the oral agent, is the medically prudent choice. Medicare covers zoledronic acid for certain people with osteoporosis who are unable to take an oral bisphosphonate because of a medical or surgical condition such as those people with:

Any amount wasted must be clearly documented in the medical record, regardless of whether the JW modifier will be used in billing for the drug/biological, with:

N/A