WPS Medicare- Iowa, Kansas, Missouri and Nebraska-Billing for Compounded Drugs

Billing for Compounded Drug Refills Used in Implantable Epidural/Subarachnoid Pain Pumps

The use of infusion pumps is covered by a National Coverage Decision (NCD) (Publication 100-03, Chapter 1, Section 280.14).

Implantable epidural/subarachnoid pain pumps need to be refilled approximately every 30 days. The capacity of these pumps is small (~18 milliliters); therefore, a highly concentrated, sterile, preservative-free solution is needed for these pump refills. A compounding pharmacy usually compounds these solutions from a powdered drug or a highly concentrated solution based on each patient's prescription, then delivers the compounded drug to the physician for pump refilling in the office/clinic setting. Some hospitals and medical centers also have the necessary equipment and sterilization facilities to prepare these solutions.

There has been some confusion regarding the billing and reimbursement for the medications used for these pain pump refills. WPS Medicare will use the guidelines listed below to reimburse providers for compounded drugs and the associated services.

Guidelines

1. When drugs are compounded for these refills, they will be paid using the method described below: baclofen (Lioresal), bupivacaine (Marcaine, Sensorcaine), clonidine (Duraclon), fentanyl (Sublimaze), hydromorphone (Dilaudid), morphine (Astramorph, Duramorph, Infumorph), sufetanil (Sufenta), and ziconotide (Prialt). Note that this is not an all inclusive list of such medications.
2. Use HCPCS code J3490 (Unclassified drugs) with one unit of service and with the KD modifier ("Drug or biological infused through DME [durable medical equipment]") for the entire compounded drug refill. Each subsequent ingredient of the compound would have one (1) unit of service and zero charges. A description for all J3490 NOC must be included in the SV101-7 data element. NDC code reporting is not required by Medicare; however, may be reported in the 2410/LIN03.
3. Drug-specific "J" codes should not be billed for these compounded drug mixtures used in epidural/subarachnoid pain pump refills. These true codes do not specifically describe the actual formulations of the drugs used in this compounding process.
4. An invoice is required for each claim. Electronic submitters should indicate that they have an invoice available upon request by putting "Documentation Available Upon Request" in the electronic equivalent of Item 19 of the CMS 1500 claim form. WPS Medicare will send an ADS (development) letter requesting the invoice, which is needed to make the payment determination. If you do not indicate the availability of the invoice, or if it you do not return it in a timely fashion, the claim may be denied as unprocessable.
5. In addition to indicating the availability of an invoice in Item 19 of the CMS 1500 form (or its electronic equivalent), include:
   1. Name of the drug;
   2. Exact total dosage (number of milligrams or micrograms) for that patient;
   3. Route of administration (i.e., "internal pump") or the brand name of the pump.
6. The correct CPT code for an implantable epidural/subarachnoid pain pump refill and maintenance without reprogramming is 95990 when performed "incident to" a physician's services, or 95991 when administered by a physician. These codes should be billed on the same claim as the compounded drug.
7. The correct code for refill with reprogramming is 62369 when performed "incident to" a physician's services, or 62370 reprogramming and refill requiring a physicians skill.
8. The correct CPT code for pump analysis without refill is 62367. The correct code for analysis with reprogramming without refill is 62368.
9. When furnished on the same day as a physician service, A4220 (Refill kit for implantable infusion pump) is considered incident to the physician service, and payment is bundled into the payment for that physician service.
10. When performed at the same time as the pump refill, an E/M service is allowed if it is provided for a significant, separately identifiable reason. The appropriate E/M code should be billed with the -25 modifier ("Significant, separately identifiable E/M service by the same physician on the day of a procedure"). The medical record must support the use of the modifier.
11. In rare situations, a compounding pharmacy may supply epidural/subarachnoid pain pump refills directly to a patient's home (POS 12) and be reimbursed by WPS Medicare. Pharmacies may not bill Medicare Part B for drugs dispensed directly to a beneficiary for administration incident to a physician's service; therefore, WPS Medicare could only make payment to a pharmacy for the compounded drug mixture if a physician's service is NOT utilized to fill the pain pump. For more information, see MLN Matters article MM 7397.

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