cpt code and description

J3420 - Injection, vitamin b-12 cyanocobalamin, up to 1000 mcg


LCD Description

Vitamin B12 (cyanocobalamin, B12) is an essential vitamin necessary for cell maturation and neurologic function. B12 deficiency may be caused by several pathological and post-surgical conditions and its presence can be assessed by B12 serum assays. This deficiency can lead to profound hematological and neurological damage, and may be corrected by oral B12, intranasal B12 gel, or intramuscular or deep subcutaneous injection. Oral replacement of vitamin B12 is the treatment of choice in most cases of deficiency. Oral administration of vitamin B12 is as effective as parenteral administration in treating deficiency in most cases. This policy will cover only the intramuscular or deep subcutaneous injection of B12 since the other two modes of replacement are both self-administered and so are not Medicare benefits. However, if the B12 deficiency can be adequately treated by other than parenteral means it would not be considered appropriate to bill Medicare for injectable B12.

This policy will briefly discuss certain tests used to determine the cause of the B12 deficiency, but the policy’s focus will be on the injection of B12 to correct the deficiency from whatever cause.

Indications and Limitations of Coverage and/or Medical Necessity

1. Generally, the indication for Vitamin B12 injection that justifies medical necessity is Vitamin B12 deficiency not corrected by oral dosing. While B12 deficiency has many causes, few of these causes will always lead to B12 deficiency. Accordingly, the physician should not give B12 just because the patient has one of the causes, but only after a deficiency has been documented by serum assay. Serum assay is a reliable initial screening test, although it does not reflect tissue status. B12 levels below 100pg/mL suggest deficiency, but discriminate poorly between 100-400pg/mL. Test results in this range may require further testing. Tests to consider include serum homocysteine, serum methylmalonic acid (MMA), and serum HoloTC-II (active vitamin B12) assays (Dharmarajan, et al.). Two causes that are exceptions to this statement are total gastrectomy and total ileal resection, both leading to B12 deficiency.

2 The normal range of serum B12 is 200 to 900 pg/ml (Harrison’s). However, the Laboratory Test Handbook states that "The lower reference limit, which is critical to the diagnosis of B12 deficiency/pernicious anemia, is not clearly established. It is likely in the range of 100-250 pg/ml." Further, Harrison’s states that "Serum methylmalonic acid and homocysteine levels…are elevated in cobalamin deficiency…

These tests measure tissue vitamin stores and may demonstrate a deficiency even when the more traditional but less reliable folate and cobalamin levels are borderline or even normal. Patients (particularly older patients) without anemia and with normal serum cobalamin levels but elevated levels of serum methylmalonic acid may develop neuropsychiatric abnormalities. Treatment of patients with this "subtle" cobalamin deficiency will usually prevent further deterioration and may result in improvement."

But note that neither serum methylmalonic acid (MMA) nor serum homocysteine tests are listed in the AMA’s CPT manual, and neither is inexpensive. Accordingly, when a patient shows neuropsychiatric abnormalities, and the serum B12 is low normal, i.e., below 350 pg/ml, the physician may, in the absence of methylmalonic acid or homocysteine tests, presume a B12 deficiency and treat the patient with B12. Likewise if MMA and /or homocysteine level (s) are available it is also appropriate to justify treatment if these levels are abnormal.

There are exceptions to the above. 

a. Since adequate absorption of dietary B12 requires a functioning stomach and ileum, complete surgical resection of either the stomach or ileum can be presumed to always lead to B12 deficiency, and that diagnosis may be presumed without a serum B12 assay and that parenteral B12 is required in these instances.

b. Utilization of certain chemotherapy drugs (Pemetrexed Disodium (Alimta?) can result in depletion of Vitamin B-12. Prophylactic use of parenteral Vitamin B12 is covered in this instance.

3. Medicare does not cover therapy to achieve supranormal B12 levels.

Other Comments

Limitation of liability and refund requirements apply when denials are likely, whether based on medical necessity or other coverage reasons. The provider/supplier must notify the beneficiary in writing, prior to rendering the service, if the provider/supplier is aware that the test, item, or procedure may not be covered by Medicare. The limitation and refund requirements do not apply when the test, item, or procedure is statutorily excluded, has no Medicare benefit category or is rendered for screening purposes.

Notice to beneficiaries related to discharge and coverage notification, as described in CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 2 sections 80-80.2, applies.

Hospitals have been instructed to provide Hospital-Issued Notices of Noncoverage (HINNs) to beneficiaries prior to admission, at admission, or at any time during an inpatient stay if the hospital determines that the care the beneficiary is receiving, or is about to receive, is not covered because if it not medically necessary, not delivered in the most appropriate setting, or is custodial in nature.

Can an  FQHC bill J3420 without encounter

Ans :

Note : Vaccine payment to FQHCs is bundled into the encounter rate.

Hepatitis B vaccine is paid on an APC basis in a hospital outpatient department. Deductible and coinsurance apply.

Influenza and pneumococcal vaccines are also paid on an APC basis in a hospital outpatient department. Neither deductible nor coinsurance apply.

HHAs cannot bill for vaccines, except on TOB 34X, since vaccines are not part of the HH benefit and cannot be paid under HH PPS.

can a provider collect deductible champva deducts from allowed amount

Ans : No.

Note : Provider should collect applicable copayments, cost-shares, or deductibles from TRICARE beneficiaries. Provider agrees to not require payment from a TRICARE beneficiary for any excluded or excludable service the TRICARE beneficiary received unless the TRICARE beneficiary has been properly informed that the services are excludable and has agreed in advance of receiving the services, in writing, to pay for such services. Any waivers must be specific as to the details of the excluded or non-covered service. If both income withholding and insurance premiums are being deducted from earnings, verification that total deduction does not exceed the maximum amount allowed by State law.

can we bill cervical collar non adjustment(foam) to medicare?

Ans :  Yes.

Note : To qualify as durable medical equipment an item must withstand repeated use, be primarily and customarily used to serve a medical purpose, be generally not useful to a person in the absence of sickness or injury, and be appropriate for use in the home.  The durable medical equipment items are covered without authorization when dispensed from the physician’s office. The identified codes are used for billing. All other codes will be denied because all other covered durable medical equipment must be obtained from a Durable Medical Equipment provider.

In the DME provider letter dated Jan. 28, 2010 - the following correction should be noted: HCPCS code L0120 has not been end-dated and is valid for coverage. The correct end-dated code is L0210.

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