Billing Non-Chemotherapy Drugs, continued
These claims must be submitted to the fiscal agent. Fee-for-service claims are entered into the claims system for the Agency for Health Care Administration (AHCA) review and pricing. Please include the name of the drug on the CMS-1500 form, so that the AHCA reviewer can quickly identify the drug being billed and expedite processing of the claim.
Reimbursement for non-chemotherapy medications is determined according to the same pricing methodology used by Medicaid pharmacy services.
The non-specific drug codes (J3490, J3590) will still be required for Medicare B billing and subsequent crossover to Medicaid.
Note: See the Florida Medicaid Prescribed Drug Services Coverage and Limitations Handbook.
Non-FDA Approved Medications
Medicaid does not reimburse for non-FDA approved medications.
Medicaid does not reimburse procedures that are experimental or when non-FDA approved medications are included in the procedures.
Evaluation and Management (E&M) Services
The cost of the injectable medication, if it is covered under Florida Medicaid, is reimbursable in addition to an E&M service. E&M services are reimbursable in addition to the administration of an injectable medication, provided the visit is for a separate and identifiable service and the services are documented in the medical record.
Federal Rebate Agreement
Medicaid will only reimburse drugs for which the manufacturer has a federal rebate agreement per Sec. 1927 [42 U.S.C. 1396r-8]. The current list of manufacturers who have drug rebate agreements is available on AHCA’s Web site at www.ahca.myflorida.com. From the Site Menu, under Division of Medicaid, select Pharmacy Services.
Chelation Therapy Medicaid only reimburses medically necessary chelation therapy for recipients with known diagnosis of toxic substances. Laboratory documentation of the toxic substance must be maintained in the recipient’s medical record.
Injectable Medication Services
, continuedMedically Accepted Indications
To be reimbursed by Medicaid, a drug must be medically necessary and either:
Prescribed for medically accepted indications and dosages found in the drug labeling or drug compendia in accordance with Section 1927(k)(6) of the Social Security Act.
Prior authorized by a qualified clinical specialist approved by the Agency.
The Agency may exclude or otherwise restrict coverage of a drug in accordance with Section 1927 of the Social Security Act.
Outpatient-administered drugs fall under the jurisdiction of the Pharmaceutical and Therapeutics Committee and their recommendations, and Agency
decisions associated with the Preferred Drug List (PDL). See the Florida Medicaid Prescribed Drug Services Coverage and Limitations Handbook for discussion of PDL.
Note: See the Prescribed Drug Services Coverage and Limitations Handbook.
Service Limitations
Medicaid does not reimburse for investigational or experimental drugs as defined in Rule 59G-1.010, F.A.C.
Investigational use, for the purposes of Medicaid reimbursement, is defined as the use of a drug, whether an FDA approved drug or not, when that drug is used as an approved product in the context of a clinical study protocol, or the use of a product for an indication that is not supported by the current body of medical literature.
Medicaid does not cover any aspect of clinical trials, including radiology follow-up scans, laboratory procedures and any other medical testing, if the drugs are provided free of charge to the recipient.
National Drug Code (NDC) Requirement
The National Drug Code (NDC) is required on all claims for drugs, including Medicare-Medicaid crossover claims. The NDC is required on the CMS-1500 claim form with the N4 qualifier on the appropriate electronic field. Claims received without the NDC will result in a denial. Submission of a valid NDC, metric unit, and metric quantity are required. The NDC number can be found on the product that is being administered to the patient. Medicaid utilizes the 11 digit format, and this may require insertion of leading zeros if they do not appear on the package (i.e., 00001-0234-05).
Note: Please see the Florida Medicaid Provider Reimbursement Handbook, CMS-1500, for instructions on entering the NDC on the claim.
Injectable Medication Services
, continuedNational Drug Code Crosswalk
The HCPCS to NDC crosswalk is published and updated quarterly by the Centers for Medicare and Medicaid (CMS). The crosswalk is accessible via the CMS Web site at www.cahabagba.com or at the following web address, www.cms.hhs.gov/McrPartBDrugAvgSalesPrice/02.
Not all drugs listed on the CMS crosswalk are eligible for reimbursement by Florida Medicaid.
Drug Wastage Medicaid will reimburse for wastage of the unused portion of a single use vial, when the dosage and wastage is clearly documented in the medical record.
Medicaid will not reimburse medication wastage without proper documentation.
Medicaid will not reimburse for wastage for multi-dose vials.
Prior
Authorization Requirements for IVIG
Intravenous Immune Globulin (IVIG) requires prior authorization. IVIG prior authorizations are managed through the Bureau of Pharmacy Services. The pharmacy clinical criteria for IVIG and the necessary prior authorization form can be found on the AHCA Web site at www.ahca.myflorida.com. From the Site Menu under the Division of Medicaid, select Pharmacy Services, next select Florida Medicaid Preferred Drug Program, and then Prior Authorization Requirements and Forms.
Botulinum Toxins Botulinum toxins are reimbursed on a per unit basis.
Evaluation and Management in Addition to Botulinum Toxin
Intramuscular and subcutaneous injections are not reimbursable in addition to an evaluation and management procedure code.
Evaluation and management services are reimbursable in addition to the botulinum toxin treatment, provided that the visit is for a separate and identifiable service, and the services are documented in the medical record.
Injection of Botulinum Toxins
Injections must be reported one time per procedure, even if multiple injections are performed in sites along a single muscle or if several muscles in a functional muscle group are injected. Bilateral procedures will be considered for
reimbursement when the documentation clearly indicates bilateral anatomical sites (i.e., right arm, left arm).
Injectable Medication Services
, continuedUse of CPT codes 95869 or 95870 (limited EMG studies) may be considered for EMG guidance if the injection site is difficult to determine. Only one procedure per visit will be reimbursed based on sufficient, clear and concise medical documentation.
A routine electromyography (EMG) is not covered. For consideration of coverage, the physician must document in the medical notes that he had difficulty in determining the proper injections site(s) for botulinum toxin.
Excluded Services Medicaid does not reimburse injectable medication services for intra-operative services. Intra-operative services are a usual and necessary part of a surgical procedure. Examples are local anesthetic, digital block, or topical anesthesia.
These services are included in the payment for a global surgery and are not reimbursable in addition to the surgical procedure(s) 10000-69999.
Medicare
Crossover Claims for J3490, J3590, and J9999
Medicare crossover claims for J-codes J3490, J3590, and J9999 are submitted from Medicare directly to the fiscal agent and are automatically paid by the system. Crossover claims for unclassified drugs do not come to AHCA for review and pricing.
Intrathecal Baclofen Therapy
Procedure
Description
Intrathecal baclofen therapy (ITB) is used to manage severe spasticity of spinal cord or cerebral origin. The drug baclofen is infused through a surgically placed neuraxial catheter to a subcutaneously implanted infusion pump designed specifically for the administration of baclofen into the intrathecal space for continued therapy.
Indications for ITB Eligibility
The following criteria must be met before placing a recipient on ITB therapy:
As indicated by at least a six week trial, the recipient cannot be maintained on non-invasive methods of spasm control, such as oral anti-spasmodic drugs (baclofen). These methods fail to control the spasticity adequately or produce intolerable side effects.
Prior to implantation of the pump, the recipient has to respond favorably to a trial intrathecal dose of the anti-spasmodic drug baclofen.
The recipient must have a positive response to a test bolus (by barbotage over not less than one minute) of intrathecal baclofen by spinal catheter or lumbar puncture before initiating long term therapy.
The intrathecal baclofen must be administered via an implantable pump that has been approved by the FDA specifically for the administration of
baclofen into the intrathecal space for continued therapy.