Intravenous vs Oral Drug Questions & Answers

Disclaimer:  The answers to these questions were prepared by National Government Services, to assist the provider community in understanding the coverage and reimbursement for oral and parenteral drugs.  These responses reflect NGS’s understanding and implementation of CMS’ instructions, and may or may not reflect the interpretations of other contractors or agencies reviewing claims.

We have received many questions regarding CMS’ policy on the medical necessity and payment for intravenous (IV) preparations of drugs when an oral preparation of the same drug is available and in common use.  The following Q&As may provide guidance for correct billing in situations when both preparations of a drug are available.

1. If an oral anti-emetic drug fails to prevent intra- or post-treatment chemotherapy induced nausea and vomiting (CINV), would an intravenous anti-emetic drug administered at the time of the next treatment session be considered medically necessary? 

If the oral anti-emetic drug was chosen appropriately and administered in an adequate dosage and failed, we would allow the intravenous form during subsequent treatments.  Such claims may be subject to medical review. 

2. Would reimbursement be contingent upon the response to the intravenous anti-emetic medication as compared to the response to the previous oral anti-emetic therapy? 

No, the reimbursement is not dependent on the result.  However, future use of the intravenous medication would require at least a better response to the intravenous anti-emetic than was achieved with the oral formulation. 

3. Would subsequent intravenous treatments be covered based upon a poor initial response to the oral formulation and an improved subsequent response to the intravenous formulation?  That is, does the provider need to re-establish that the oral anti-emetic is still ineffective after the initial failure and before each start of the intravenous drug?

The patient does not need to fail the oral form with each course of therapy.   Subsequent IV courses would be covered. 

4. If a patient has a positive response to intravenous treatment after failure of the oral preparation, does that support medical necessity of the intravenous formulation for that patient only, or for all similar patients? 

Medical necessity is supported only for the individual patient.  Because the intravenous form was necessary in one patient, that does not provide clinical evidence that the IV form will be necessary in all such patients. 

5. If a patient has taken oral anti-emetics prior to presenting for treatment and still experiences pre-treatment nausea, would the provider be reimbursed for intravenous administration of additional anti-emetics at that time? 

Yes, if the nausea prevented the administration of the additional dose in the oral form.   The inability to take oral medication at the time of treatment is considered a medically necessary reason to administer intravenous preparations.

6. If the IV form of an anti-emetic is medically necessary, would concomitant prophylactic Benadryl and Decadron also be covered if administered intravenously? 

No, not necessarily.  The parenteral administration of any particular drug in place of its oral formulation would not be covered unless it was medically necessary.  If the patient were on intravenous anti-emetics without concomitant nausea and/or vomiting, and there was no other medically necessary indication for the use of parenteral Benadryl or Decadron, then the parenteral form of Benadryl and Decadron would not be covered.

7. Can IV Benadryl be covered in the absence of nausea/vomiting? 

The IV form can be covered only if the oral form was unable to be ingested or was medically contraindicated for some other reason, or if needed to treat an acute allergic reaction, or recommended in the FDA labeling for the chemotherapy drug, or the scientific medical literature for the administered chemotherapy drug documents that intravenous administration is preferred or required.

8. Can IV Decadron be covered in the absence of nausea/vomiting? 

The IV form can be covered only if the oral form was unable to be ingested or was medically contraindicated for some other reason, or if needed to treat an acute allergic reaction, or recommended in the FDA labeling for the chemotherapy drug, or the scientific medical literature for the administered chemotherapy drug documents that intravenous administration is preferred or required.

9. Under which specific circumstances, other than inability to ingest or swallow oral medications (e.g., physical obstruction of the esophagus or active nausea or vomiting) at the time of, or prior to, chemotherapy treatment can anti-emetics, antihistamines, steroids, or other medications be covered when administered intravenously?  Please identify the specific conditions that would be considered “medically necessary.” 

It is impractical to list every possible medical reason that IV medication would be necessary. It is expected that the attending clinician would be able to determine whether the reason for IV administration is medically necessary rather than for convenience, patient preference, or for financial considerations.

10.  If a patient fails on an oral anti-emetic drug, can the provider be reimbursed if a patient is administered intravenous drugs or must another, different oral drug be tried? 

The provider may be reimbursed for using the intravenous formulation of the same drug.  However, if the provider wishes to use the intravenous formulation of a different drug, then the oral formulation of that different drug must be shown to be ineffective or contraindicated before the IV form is covered.

11.    Will scientific studies of chemotherapy regimens utilizing only intravenous formulations be sufficient to document the medical necessity for IV forms of chemotherapy drugs that exist in both oral and intravenous forms? 

If studies of chemotherapy treatment regimens were performed using only IV forms of the chemotherapy drug, then the IV form would be covered, since the oral form had not been proven to be effective.  However, if studies show that both oral and IV forms are effective, then the IV vs. oral rules would apply. 

12.  If the patient develops CINV after administration of an oral anti-emetic (other than Emend), can they receive IV Emend at the next treatment without having first tried oral Emend? 

No, oral Emend may be more effective in a particular instance than other oral anti-emetics, so the oral formulation of the Emend must be tried before using the intravenous formulation.

13.  If a patient develops uncontrolled CINV while receiving IV Aloxi, can they receive a stat dose of IV Emend?

Yes, concurrent CINV that prevents oral ingestion is a medically acceptable reason for the intravenous formulation of an anti-emetic.

14.  If a patient has gastritis, or history of gastritis, can they receive subsequent doses of Decadron intravenously?

We are currently researching this issue to determine whether gastritis, or a history of gastritis, is significantly affected by the route of administration, or whether the patient should be treated with an appropriate H2 blocker or proton pump inhibitor.

15.  Can a patient receive Decadron, Benadryl or Tagamet intravenously for preventative treatment when administering chemotherapies with a high incidence of reactions, such as Taxol, Taxotere or Rituxan?

No, there has to be a medically necessary indication for use of the parenteral route of administration. That is, the oral form has to have been shown to be ineffective or otherwise contraindicated for a particular indication before the intravenous route of administration is covered.