Injections Drugs M Z Policy inject drug m z Sodium Hyaluronate

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Injections: Drugs M-Z Policy                                                                                  1
This section outlines policy related to billing for injection services, listed in alphabetical order by generic
drug name or drug type. For general billing policy information regarding injections services, refer to the
Injections: An Overview section in this manual. Additional policy information for injection services can be
found in the Injections: Drugs A─L Policy, Injections: Hydration and Immunizations sections in this
manual.


Medroxyprogestereone                 HCPCS injection code X6051 (medroxyprogestereone,
             ®
(Depo-Provera )                      C-150 mg/ml; 1 ml vial) is used specifically as an injectable
                                     contraceptive. For billing information, refer to the Family Planning
                                     section in the appropriate Part 2 manual.

                                     For HCPCS injection codes X6046 and X6048, refer to the
                                     Chemotherapy section in the appropriate Part 2 manual.



Mesna                                Mesna (HCPCS code X7586), a synthetic sulfhydryl compound, is
                                     used in conjunction with ifosfamide (HCPCS code X7584) to prevent
                                     hemorrhagic cystitis.


Dosage                               Mesna is given in three separate intravenous boluses, with the dosage
                                     of each bolus equal to 20 percent of the ifosfamide dosage. Mesna is
                                     given at the time of ifosfamide administration and at four and eight
                                     hours after ifosfamide administration. The total daily mesna dosage is
                                     60 percent of the ifosfamide dosage.


Billing                              Mesna is reimbursable only if billed in conjunction with ifosfamide.
                                     Providers must state in the Remarks field (Box 80)/Reserved for Local
                                     Use field (Box 19) that mesna was used in conjunction with ifosfamide.
                                     CPT-4 code 96375 (therapeutic, prophylactic or diagnostic injection;
                                     each additional sequential intravenous push of a new substance/drug)
                                     may be reimbursed when billed in conjunction with mesna.




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Methotrexate                       Injectable methotrexate is reimbursable when used in the treatment of
                                   both malignant and non-malignant diseases.


Dosage                             Due to the wide variety of diseases and dosages in which
                                   methotrexate is used, a usual, recommended or maximum dose
                                   cannot be stated.


Billing                            HCPCS code J9260 (methotrexate sodium, 50 mg);
                                   one (1) unit = 50 mg.

                                   Note: If less than 50 mg is administered, one unit may be submitted
                                         on the claim form.



Methylene Blue                     Methylene blue, 1 ml, is billed with HCPCS injection code A9535.
                                   Claims must include documentation to justify medical necessity when
                                   billed in excess of 20 ml.




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                               ®
Micafungin (Mycamine )             Micafungin is a semi-synthetic water-soluble lipopeptide of the
                                   echinocandin class of antifungal agents. It inhibits the synthesis
                                   of 1, 3 beta-D-glucan, an integral component of fungal cell wall
                                   synthesis. It exhibits fungicidal activity against Candida species
                                   and fungistatic activity against Aspergillus species.


Indications                        Micafungin is indicated for:

                                        Treatment of patients with candidemia, acute disseminated
                                         candidiasis, candida peritonitis and abscesses
                                        Treatment of patients with esophageal candidiasis
                                        Prophylaxis of candida infections in patients undergoing
                                         hematopoietic stem cell transplantation
                                        Treatment or prophylaxis of other cancer related fungal
                                         infections such as but not limited to patients who have received
                                         a bone marrow transplant


Authorization                      Not required.


Dosage                             The usual dose is 50 – 150 mg daily for the duration of treatment or
                                   prophylactic therapy.


Billing                            HCPCS Code
                                   J2248 Injection, micafungin sodium, 1 mg



                           ®
Natalizumab (Tysabri )             Natalizumab, 1 mg (HCPCS injection code J2323), is reimbursable for
                                   the treatment of multiple sclerosis (ICD-9-CM diagnosis code 340) or
                                   regional enteritis (ICD-9-CM diagnosis code range 555.0 – 555.9).
                                   The maximum daily dosage is 300 mg. Claims billed for quantities
                                   exceeding the daily limitation require appropriate documentation for
                                   payment.




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                         ®
Omalizumab (Xolair )               Omalizumab, 5 mg injection (HCPCS code J2357) is reimbursable for
                                   the treatment of asthma with an approved Treatment Authorization
                                   Request (TAR). Documentation showing the following must be
                                   submitted with the TAR:
                                       Recipient is 12 years of age or older and has a diagnosis of
                                        moderate or severe persistent asthma for more than one year
                                       Recipient is symptomatic despite combination therapy with
                                        inhaled corticosteroid and long-acting beta2-agonist, with or
                                        without additional medications, or is on chronic or recurrent oral
                                        corticosteroid therapy
                                       Recipient has a positive testing for a perennial aeroallergen and
                                        a serum IgE level greater than 30 but less than 700 IU/ml
                                       Patient evaluation, preparation of management plan, and
                                        monitoring of asthma treatment for omalizumab have been
                                        done by a physician who is board-eligible or board-certified in
                                        any specialty and is experienced in the diagnosis and treatment
                                        of asthma and allergic diseases.




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OnabotulinumtoxinA                 OnabotulinumtoxinA (BOTOX) is reimbursable for the treatment of any
(BOTOX)                            of the following:

                                          Adults with cervical dystonia
                                          Achalasia (see Authorization below)
                                          Anal fissure *
                                          Detrusor sphincter dyssynergia *
                                          Frey’s Syndrome *
                                          Hemifacial spasm
                                          Neurogenic overactive bladder muscle dysfunction *
                                          Severe primary axillary hyperhidrosis that is inadequately
                                           managed with topical agents * (see following “Authorization”
                                           information)
                                          Spasticity
                                          Spasmodic dysphonia
                                          Sialorrhea *
                                          Strabismus and blepharospasm associated with dystonia,
                                           including benign essential blepharospasm or VII nerve
                                           disorders in patients 12 years of age and older

                                           Note: The efficacy of onabotulinumtoxinA treatment in
                                                 deviations over 50 prism diopters, in restrictive
                                                 strabismus, in Duane’s syndrome with lateral rectus
                                                 weakness, and in secondary strabismus caused by prior
                                                 surgical over-recession of the antagonist has not been
                                                 established. OnabotulinumtoxinA is ineffective in chronic
                                                 paralytic strabismus except when used in conjunction
                                                 with surgical repair to reduce antagonist contracture.

                                   * Establishing medical necessity is critical and the TAR should clearly
                                     state that the patient has been unresponsive to conventional
                                     methods of treatments such as medication, physical therapy and
                                     other appropriate methods used to control or treat this condition.




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                                   The botulinum toxins are a family of neurotoxins produced by various
                                   toxigenic strains of the gram-positive anaerobic bacterium Clostridium
                                   botulinum and are comprised of seven antigenically distinct serotypes
                                   (A to G). All botulinum neurotoxin serotypes produce their clinical
                                   effect of flaccid paralysis by blocking the release of acetylcholine from
                                   nerve endings.

                                   Three botulinum toxin products have been approved by the U.S. Food
                                   and Drug Administration (FDA).

                                   Two botulinum toxin serotype A products:

                                        AbobotulinumtoxinA (DYSPORT)
                                        OnabotulinumtoxinA (BOTOX)

                                   One botulinum toxin serotype B product:

                                        RimabotulinumtoxinB (Myobloc)

                                   A significant difference within botulinum toxin type A serotypes is that
                                   the units are not interchangeable between the two FDA-approved
                                   products as there is no common international standard methodology
                                   for assaying units within the botulinum toxin serotypes. Therefore one
                                   unit of abobotulinumtoxinA is not equivalent to one unit of
                                   onabotulinumtoxinA. Similarly the units of one botulinum toxin
                                   serotype cannot be converted into units of any other botulinum toxin
                                   serotype as there is no common international standard methodology
                                   for assaying units among the different botulinum toxin serotypes.
                                   Consequently neither the units of abobotulinumtoxinA nor
                                   onabotulinumtoxinA are interchangeable with rimabotulinumtoxinB.
                                   The dosing of any botulinum toxin product must be individualized to
                                   each specific patient based upon many factors including but not limited
                                   to size of the muscles to be injected, the number of muscles to be
                                   injected, body weight, the condition being treated, expected patient
                                   response and general health of the patient. Standard doses do not
                                   exist.




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Authorization                      Medical necessity must be established and an approved TAR is
                                   required for reimbursement.

                                   If the request is for the treatment of primary axillary hyperhidrosis, the
                                   TAR must document that there is significant impairment of daily
                                   activities and the episodes occur at least once per week.

                                   If the request is for the treatment of achalasia, the TAR must
                                   document any of the following:

                                          Failed pneumatic dilation or myotomy
                                          Poor surgical candidate
                                          High risk for complications such as perforation
                                          History of hiatal hernia or epiphrenic diverticulum
                                          History of perforation


Dosing                             The dose of onabotulinumtoxinA is highly variable dependent upon
                                   which condition is being treated and individual patient response. The
                                   initial recommended dose for the treatment of:

                                        Blepharospasm or strabismus is 1.25 – 2.5 units
                                        Primary axillary hyperhidrosis is 50 units
                                        Cervical dystonia is variable


Billing                            HCPCS Code
                                   J0585 Injection, onabotulinumtoxinA, 1 unit
                                   One (1) unit = 1 unit of onabotulinumtoxinA

                                   Due to the short half life of onabotulinumtoxinA, Medi-Cal will
                                   reimburse the unused portion of the drug only when vials are not split
                                   between patients. Scheduling of more than one patient is encouraged
                                   to prevent wastage of onabotulinumtoxinA. If a vial is split between
                                   two or more patients, the billing must be for the exact amount of drug
                                   administered to each individual patient.




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Ondansetron HCl (Zofran)           Ondansetron HCl injections, 1 mg (HCPCS code J2405), is used for
                                   the prevention of nausea and vomiting associated with the initial and
                                   repeated courses of emetogenic cancer chemotherapy (including
                                   high-dose cisplatin) and the prevention of postoperative nausea and/or
                                   vomiting. Because this injection is most effective on the first day of a
                                   course of chemotherapy, its use is reimbursable only one calendar day
                                   per week.


Dosage                             The usual and maximum dose for one calendar day is either a single
                                   dose of 32 mg, or three (3) separate doses of 0.15 mg/kg taken at
                                   four-hour intervals (for example, one dose at “0” hours; a second dose
                                   at “4” hours; and a third dose at “8” hours).


Billing                            When billing code J2405 for more than 61 mg, providers must
                                   document in the Remarks field (Box 80)/Reserved for Local Use field
                                   (Box 19) that the patient weighs more than 136 kg.




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                            ®
Palifermin (Kepivance )            Reimbursement for palifermin, 50 mcg, (HCPCS injection code J2425)
                                   is allowed up to a maximum of 140 units.



Palonosetron                       Palonosetron (Aloxi) 25 mcg (HCPCS code J2469) is reimbursable for
                                   acute and delayed emesis due to emetogenic chemotherapy.
                                   Palonosetron may be combined with aprepitant and dexamethasone
                                   for maximal patient benefit for both acute and delayed emesis due to
                                   highly emetogenic chemotherapy.


Dosage                             A single intravenous dose of 0.25 mg delivered over 30 seconds is
                                   given 30 minutes before chemotherapy. CPT-4 code 96375
                                   (therapeutic, prophylactic or diagnostic injection; each additional
                                   sequential intravenous push of a new substance/drug) may be
                                   reimbursed when billed in conjunction with palonosetron.




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                          ®
Pamidronate (Aredia )              Pamidronate (Aredia), 30mg, an aminohydroxypropylidene
                                   biphosphonate, is reimbursable for the outpatient treatment of
                                   hypercalcemia of malignancy with or without bone metastases,
                                   Paget’s disease, and osteolytic bone lesions of breast and prostate
                                   cancer and osteolytic bone lesions of multiple myeloma.


Required Codes                     Pamidronate must be billed in conjunction with CPT-4 codes 96365
                                   (intraveous infusion for therapy prophylaxis or diagnosis; initial, up to
                                   1 hour) and 96366 (…each additional hour) when billed for outpatient
                                   treatment with one of the following ICD-9-CM diagnosis codes:
                                   174.0 – 175.9, 185, 198.5, 203.00 – 203.02, 203.12, 275.42 or 731.0.


Billing                            For billing, use HCPCS code X7444 (pamidronate, 30 mg).




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                           ®
Paricalcitol (Zemplar )            Paricalcitol is reimbursable for the prevention and treatment of
                                   secondary hyperparathyroidism in patients with chronic kidney
                                   disease on dialysis.


Dosage                             The recommended initial dose of paricalciferol is 0.04 mcg/kg to
                                   0.1 mcg/kg administered intravenously as a bolus dose no more
                                   frequently than every other day at any time during dialysis. The
                                   maximum dose should not exceed 30 mcg weekly.


Billing                            HCPCS code J2501 Injection, paricalcitol, 1 mcg;
                                   one unit = 1 mcg



Pegademase Bovine                  Claims for pegademase bovine, 25 IU, (HCPCS injection code J2504)
       ®
(Adagen )                          must be billed with ICD-9-CM codes 277.2 (other disorders of purine
                                   and pyrimidine metabolism) or 279.2 (combined immunity deficiency).



                               ®
Pegaptanib (Macugen )              Pegaptanib sodium, 0.3 mg, (HCPCS injection code J2503) is covered
                                   for the treatment of macular degeneration. Authorization is required.




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                              ®
Pegfilgrastim (Neulasta )          Pegfilgrastim is reimbursable for the management of neutropenia
                                   associated with chemotherapy in patients who have non-myeloid
                                   malignancies and are at high risk for infection.


Dosage                             The recommended dosage of pegfilgrastim is a single 6 mg
                                   subcutaneous injection. The injection should not be given between
                                   14 days before and 24 hours after each chemotherapy cycle because
                                   stimulation of myeloid cells during that time might increase
                                   chemotherapy-related myelosuppression. Pegfilgrastim should not be
                                   given to recipients who weigh less than 45 kg.


Required Codes                     Pegfilgrastim is reimbursable when billed with ICD-9-CM codes
                                   288.03, V07.8, V58.11 or V66.2.


Billing                            HCPCS code J2505 (pegfilgrastim, 6 mg);
                                   one (1) unit = 6 mg.




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                        ®
Plerixafor (Mozobil )              Plerixafor may be reimbursed for the treatment of patients
                                   with non-Hodgkin’s lymphoma or multiple myeloma undergoing
                                   autologous hematopoietic stem cell transplantation.


Indications                        Plerixafor is indicated in combination with granulocyte-colony
                                   stimulating factor (G-CSF) to mobilize hematopoietic stem cells to the
                                   peripheral blood for collection and subsequent autologous
                                   transplantation in patients with non-Hodgkin’s lymphoma or multiple
                                   myeloma.


Dosage                             The recommended dose is 0.24 mg/kg body weight by subcutaneous
                                   injection. The maximum dose is 40 mg per day without exception.
                                   Providers must use the patient’s actual body weight in calculating the
                                   dose. G-CSF should be administered in the morning daily for four
                                   days prior to the first evening dose of plerixafor and on each day prior
                                   to apheresis. Plerixafor should be administered approximately
                                   11 hours prior to the initiation of apheresis for up to four consecutive
                                   days.


Required Codes                     Plerixafor is reimbursable only with ICD-9-CM codes 200.00 – 200.89
                                   and 202.00 – 203.02.


Billing                            HCPCS code C9252 injection, plerixafor, 1 mg



Protein C Concentrate              Protein C concentrate, intravenous, human, 10 IU (HCPCS code
(Ceprotin)                         J2724) is reimbursable when billed with ICD-9-CM diagnosis
                                   code 289.81 and has a maximum daily dosage of 16,360 IU.




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Ranibizumab (Lucentis™)            Policy for intravitreal ranibizumab (HCPCS code J2778) is located in
                                   the Ophthalmology section of the provider manual.



RimabotulinumtoxinB                RimabotulinumtoxinB is reimbursable for the treatment of any of
(Myobloc)                          the following:

                                          Adults with cervical dystonia
                                          Overactive bladder muscle dysfunction *
                                          Sialorrhea *
                                          Spasticity

                                       * Establishing medical necessity is critical and it should be made
                                         clear that the patient has been unresponsive to conventional
                                         methods of treatments such as medication, physical therapy
                                         and other appropriate methods used to control or treat this
                                         condition.

                                   The botulinum toxins are a family of neurotoxins produced by various
                                   toxigenic strains of the gram-positive anaerobic bacterium Clostridium
                                   botulinum and are comprised of seven antigenically distinct serotypes
                                   (A to G). All botulinum neurotoxin serotypes produce their clinical
                                   effect of flaccid paralysis by blocking the release of acetylcholine from
                                   nerve endings.

                                   Three botulinum toxin products have been approved by the U.S. Food
                                   and Drug Administration (FDA).

                                   Two botulinum toxin serotype A products:

                                        AbobotulinumtoxinA (DYSPORT)
                                        OnabotulinumtoxinA (BOTOX)

                                   One botulinum toxin serotype B product:

                                        RimabotulinumtoxinB (Myobloc)




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                                   A significant difference within botulinum toxin type A serotypes is that
                                   the units are not interchangeable between the two FDA-approved
                                   products as there is no common international standard methodology
                                   for assaying units within the botulinum toxin serotypes. Therefore one
                                   unit of abobotulinumtoxinA is not equivalent to one unit of
                                   onabotulinumtoxinA. Similarly the units of one botulinum toxin
                                   serotype cannot be converted into units of any other botulinum toxin
                                   serotype as there is no common international standard methodology
                                   for assaying units among the different botulinum toxin serotypes.
                                   Consequently neither the units of abobotulinumtoxinA nor
                                   onabotulinumtoxinA are interchangeable with rimabotulinumtoxinB.
                                   The dosing of any botulinum toxin product must be individualized to
                                   each specific patient based upon many factors including but not limited
                                   to size of the muscles to be injected, the number of muscles to be
                                   injected, body weight, the condition being treated, expected patient
                                   response and general health of the patient. Standard doses do not
                                   exist.


Authorization                      Medical necessity must be established and an approved TAR is
                                   required for reimbursement.


Dosing                             The recommended initial dose of rimabotulinumtoxinB is 2,500 to
                                   5,000 units divided among affected muscles. Subsequent dosing
                                   should be optimized according to the patient’s individual response.


Billing                            HCPCS Code
                                   J0587 Injection, rimabotulinumtoxinB, 100 units
                                   One (1) unit = 100 units of rimabotulinumtoxinB

                                   Due to the short half life of rimabotulinumtoxinB, Medi-Cal will
                                   reimburse the unused portion of the drug only when vials are not split
                                   between patients. Scheduling of more than one patient is encouraged
                                   to prevent wastage of rimabotulinumtoxinB. If a vial is split between
                                   two or more patients, the billing must be for the exact amount of drug
                                   administered to each individual patient.




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                         ®
Rituximab (Rituxan )               Rituximab (HCPCS code J9310) in combination with methotrexate, is
                                   indicated to reduce the signs and symptoms and to slow the
                                   progression of structural damage in patients with moderately to
                                   severely active rheumatoid arthritis who have had an inadequate
                                   response to one or more tumor necrosis factor antagonist therapies.
                                   Refer to “Rituximab” in the Chemotherapy section of this manual for
                                   the use of rituximab in malignant disease.


Documentation                      Rituximab does not require a TAR. Providers must document on the
Requirements                       claim form in the Remarks field (Box 80)/Reserved for Local Use field
                                   (Box 19), or on an attachment to the claim, all of the following:
                                        Documentation that the patient has had an inadequate
                                         response after treatment with the following:
                                         – One or more non-biologic Disease-Modifying
                                           Anti-Rheumatic Drugs (DMARDs) and
                                         – At least one or more tumor necrosis factor (TNF)
                                           antagonists (infliximab, etanercept or adalimumab)
                                           or the interleukin-1 receptor antagonist anakinra.


Required Codes                     A diagnosis code of 714.0 – 714.9 is required.


Medical Considerations             Providers should consider the following when administering rituximab
                                   for rheumatoid arthritis:
                                        In combination with methotrexate, the usual dose of rituximab
                                         for rheumatoid arthritis is 1000 mg by infusion, given in two
                                         doses that are separated by two weeks.
                                        In order to reduce the incidence and severity of infusion
                                         reactions, it is advised that most patients receive
                                         methylprednisolone, 100 mg intravenously , or equivalent
                                         glucocorticoid, 30 minutes prior to each infusion.
                                        Rituximab should never be administered as an intravenous
                                         push or bolus. Re-treatment for rheumatoid arthritis should not
                                         be sooner than 16 weeks, and in the clinical trials, most of the
                                         patients who received additional courses received such 24
                                         weeks after the previous course.


Billing                            HCPCS code J9310 (rituximab, 100 mg);
                                   one (1) unit = 100 mg.




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                              ®
Sargramostim (Leukine )            Sargramostim is reimbursable when used for the following
                                   medical conditions:

                                        Following induction chemotherapy in acute myelogenous
                                         leukemia
                                        Mobilizing and following transplantation of autologous peripheral
                                         blood progenitor cells
                                        Following autologous bone marrow transplantation in myeloid
                                         reconstitution
                                        Following allogeneic bone marrow transplantation in myeloid
                                         reconstitution
                                        In bone marrow transplantation failure or engraftment delay
                                        Neutropenia induced by chemotherapy
                                        Neutropenia associated with myelodysplastic syndromes
                                                                                                   2
                                   The usual recommended dosage of sargramostim is 250 mcg/m
                                   administered intravenously over two hours. It may also be given as a
                                   subcutaneous injection. When billing for sargramostim, providers
                                   must document the chemotherapeutic agent, if used, including the
                                   dosage and duration of use.


Procedure Codes                    The following HCPCS codes are used to bill sargramostim.

                                       HCPCS
                                       Code             Dosage
                                       X7364            Sargramostim 250 mcg/vial
                                       X7366            Sargramostim 500 mcg/vial




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Required Codes                     Sargramostim (X7364 or X7366) is reimbursable when billed in
                                   conjunction with one of the following ICD-9-CM codes:
                                       140.0 – 149.9       190.0 – 199.1
                                       150.0 – 159.9       200.00 – 208.91
                                       160.0 – 165.9       230.0 – 234.9
                                       170.0 – 175.9       235.0 – 239.9
                                       179.0 – 189.9

                                   When billing sargramostim for any other than the above diagnosis
                                   codes, providers must include documentation that it was used to treat
                                   severe neutropenia induced by a course of chemotherapy or that it
                                   was used in conjunction with a bone marrow transplant.

                                   Sargramostim may be billed in conjunction with CPT-4 codes
                                   96401 (chemotherapy administration, subcutaneous or intramuscular;
                                   non-hormonal anti-neoplastic), 96402 (…hormonal anti-neoplastic),
                                   96413 (chemotherapy administration, infusion technique; up to one
                                   hour) and 96415 (…each additional hour, one to eight hours).



                        ™
Secretin (SecreFlo )               Secretin is indicated for use in secretin stimulation testing:

                                   (1) to aid in the diagnosis of pancreatic exocrine dysfunction
                                   (2) to aid in the diagnosis of gastrinoma
                                   (3) to facilitate the identification of the ampulla of Vater and accessory
                                       papilla during endoscopic retrograde cholangiopancreatography.


Dosage                             The maximum allowable dosage is 48 mcg.


Billing                            HCPCS code J2850 (injection, secretin, synthetic, human, 1 mcg)




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Sermorelin Acetate                 Sermorelin acetate, 1 mcg (HCPCS code Q0515) is covered,
                                   subject to authorization, for disorders of the pituitary gland and its
                                   hypothalamic control.


Required Codes                     Providers must submit the appropriate ICD-9-CM code
                                   (253.0 – 253.9) on the TAR.



Sodium Hyaluronate                 Sodium hyaluronate (Euflexxa) for intra-articular injection is
(Euflexxa)                         reimbursable for treatment of the knees. Authorization is required and
                                   documentation must be submitted with the TAR that satisfies all of the
                                   following conditions:
                                        Painful osteoarthritis of one or both knees
                                        Inadequate response to conservative nonpharmacologic
                                         therapy
                                        Inadequate response to simple analgesics (for example,
                                         acetaminophen) and non-steroidal anti-inflammatory drugs


Dosage                             The usual dose is 2 ml of sodium hyaluronate (Euflexxa) into the
                                   affected knee at weekly intervals for three weeks for a total of three
                                   injections per affected knee.


Billing                            HCPCS code J7323 Hyaluranon or derivative, Euflexxa, for
                                   intra-articular injection, per dose




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Sodium Hyaluronate                 Sodium hyaluronate (Hyalgan) for intra-articular injection is
(Hyalgan)                          reimbursable for treatment of the knees. Authorization is required and
                                   documentation must be submitted with the TAR that satisfies all of the
                                   following conditions:
                                        Painful osteoarthritis of one or both knees
                                        Inadequate response to conservative nonpharmacologic
                                         therapy
                                        Inadequate response to simple analgesics (for example,
                                         acetaminophen) and non-steroidal anti-inflammatory drugs


Dosage                             The usual dose is 2 ml of sodium hyaluronate (Hyalgan) into the
                                   affected knee at weekly intervals for up to five weeks for a total of five
                                   injections per affected knee. Some patients may experience benefit
                                   with three injections at weekly intervals.


Billing                            HCPCS code J7321 Hyaluranon or derivative, Hyalgan or Supartz, for
                                   intra-articular injection, per dose




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Sodium Hyaluronate                 Sodium hyaluronate (Supartz) for intra-articular injection is
(Supartz)                          reimbursable for treatment of the knees. Authorization is required and
                                   documentation must be submitted with the TAR that satisfies all of the
                                   following conditions:
                                        Painful osteoarthritis of one or both knees
                                        Inadequate response to conservative nonpharmacologic
                                         therapy
                                        Inadequate response to analgesics (for example,
                                         acetaminophen) and non-steroidal anti-inflammatory drugs


Dosage                             The usual dose is 2.5 ml of sodium hyaluronate (Supartz) into the
                                   affected knee at weekly intervals for up to five weeks for a total of five
                                   injections per affected knee. Some patients may experience benefit
                                   with three injections at weekly intervals.


Billing                            HCPCS code J7321 Hyaluranon or derivative, Hyalgan or Supartz, for
                                   intra-articular injection, per dose




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Somatropin (Serostim)             Somatropin is used for the treatment of HIV-associated wasting and
for HIV-Associated Wasting         is reimbursable only with an approved TAR. A TAR will be granted
                                   in four-week intervals to a maximum of 12 continuous weeks of
                                   therapy. Treatment must be reevaluated after four weeks and eight
                                   weeks of therapy.


Initial Therapy: Criteria          Criteria for the initial 28 days of treatment of HIV-associated wasting
                                   with somatropin:

                                        Documentation in the medical record of complete history and
                                         physical examination including:
                                          – History of nutritional status including appetite, estimation of
                                            caloric intake, gastrointestinal function including presence of
                                            diarrhea and number of daily stools, and history of
                                            endoscopic procedures
                                          – Psychosocial evaluation, including presence of significant
                                            anxiety and/or depression affecting food intake
                                        Record of the following measurements:
                                             Height, weight, ideal body weight, body mass index (BMI)
                                             Body cell mass (BCM) by bioelectrical impedance analysis
                                              (BIA)
                                             Serial measurements – weekly
                                        Recipients must meet one of the following criteria for
                                         HIV-associated wasting:
                                             5 percent BCM loss within the preceding six months
                                             In men: BCM less than 35 percent of total body weight and
                                                                    2
                                              BMI less than 27 kg/m
                                             In women: BCM less than 23 percent of total body weight
                                                                        2
                                              and BMI less than 27 kg/m
                                                                      2
                                             BMI less than 20 kg/m
                                                                          2                     2
                                             BMI greater than 20 kg/m and less than 25 kg/m
                                              and
                                               10 percent unintentional weight loss within the preceding
                                                12 months
                                              or
                                               7.5 percent unintentional weight loss within the preceding
                                                six months




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                                    Recipients should have an evaluation of gastrointestinal
                                     function with attention to the presence of malabsorption, a
                                     review of food intake, amount of daily calories and estimate of
                                     physical activity level.
                                    An active malignancy other than Kaposi’s sarcoma has been
                                     excluded clinically, through diagnostic laboratory examination,
                                     and/or radiographically.
                                    Male recipients should have a serum testosterone level and, if
                                     low, a trial of testosterone replacement therapy.
                                    Recipients must have a viral load assay and a CD4 count and
                                     must be undergoing treatment with an appropriate antiretroviral
                                     therapy regimen.
                                    Recipients should have a trial with an appetite stimulant if the
                                     recipient has inadequate caloric intake and anorexia.
                                    For male recipients, an initial trial of androgen is recommended
                                     for HIV-associated wasting. If this is omitted, a statement
                                     should be provided documenting the clinical decision to proceed
                                     directly with somatropin therapy.
                                    Recipients must receive somatropin within recommended
                                     dosing guidelines for body weight.




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Reassessment of Therapy            Criteria for reassessment of therapy through 12 weeks:
Through 12 Weeks: Criteria
                                        Treatment must be re-evaluated after four weeks and eight
                                         weeks of therapy. Repeat weight assessment and
                                         documentation is required at four weeks and eight weeks of
                                         therapy to assure weight stabilization.
                                        Therapy must be discontinued in recipients who continue to
                                         lose weight in the first four weeks of treatment.
                                        If, after four weeks of therapy, weight loss has stopped or if the
                                         recipient is gaining weight, somatropin may be continued for
                                         another 28 days.
                                        If, after eight weeks of therapy, the recipient is losing or has
                                         failed to gain weight from the original measurement,
                                         somatropin must be stopped.
                                        If the recipient had initially gained weight at four weeks, but has
                                         neither gained nor lost weight at the eight-week re-evaluation,
                                         somatropin may be continued for another 28 days.
                                        A maximum of 12 weeks of treatment is allowed with
                                         authorization. Claims without authorization will be denied.
                                         Note: Authorization is limited to four-week intervals.




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Continued Therapy Beyond           Criteria for continued therapy beyond the initial 12 weeks:
12 Weeks: Criteria
                                        All recipients must stop somatropin following the initial 12-week
                                         treatment for an eight-week period of observation unless there
                                         is documentation that HIV-associated wasting is still present.
                                         During the eight-week observation period, body weight, BMI and
                                         BCM should be monitored on a weekly basis.
                                        Therapy beyond 12 weeks may be continued with a recipient
                                         who has demonstrated a beneficial response to somatropin
                                         during the initial 12 weeks of therapy (defined as a 2 percent or
                                         greater increase in body weight or BCM)
                                          and
                                                                                                        2
                                             Still exhibits evidence of wasting (BMI less than 20 kg/m )
                                              or
                                             Has a BCM not yet normalized (BCM less than 40 percent in
                                              non-obese men or less than 28 percent in non-obese
                                              women).
                                        As long as the recipient continues to gain weight or BCM,
                                         somatropin may be extended every 28 days, with authorization,
                                         until BCM and/or weight are normalized.
                                        Once BCM and/or weight have normalized, somatropin should
                                         be stopped.



Reinitiating Somatropin Therapy    Criteria for reinitiating somatropin therapy within six months:
Within Six Months: Criteria
                                        Recipients may resume somatropin therapy within six months
                                         of initial therapy if there is documentation of an unintentional
                                         5 percent loss of body weight or BCM loss of greater than
                                         5 percent or any of the criteria for HIV-associated wasting within
                                         six months after completion of an uninterrupted 12-week
                                         course of somatropin therapy.
                                        Reinitiating somatropin is allowed for up to an additional
                                         12 weeks, with reassessments required at the same four and
                                         eight week intervals during the second 12-week course of
                                         therapy. A recent copy of the recipient’s BIA documenting the
                                         BCM loss is required with TAR submission.




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Repeat Somatropin Therapy          Criteria for repeat somatropin therapy six months after cessation of
After Cessation: Criteria          treatment:

                                        If the recipient has not re-initiated somatropin six months after
                                         completing an uninterrupted 12-week course of therapy,
                                         somatropin may be repeated, provided the criteria for initial
                                         28 days of therapy are met. Reinitiating somatropin is allowed
                                         for up to an additional 12 weeks, with reassessments required
                                         at the same four- and eight-week intervals during the second
                                         12-week course of therapy. A recent copy of the recipient’s BIA
                                         is required with TAR submission.
                                        Trials of alternate treatment may be omitted if previous use in
                                         the recipient was unsuccessful. The use of somatropin beyond
                                         the initial 12-week course must meet the criteria stated above
                                         for continued treatment.




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Streptokinase                      When intravenous thrombolytic agents are used in Acute Myocardial
                                   Infarction (AMI) cases, Medi-Cal only reimburses the cost of the agents.
                                   Streptokinase is a commonly used agent in AMI cases.


Place of Service Restrictions      Streptokinase use is separately reimbursable when treatment is
                                   initiated in an organized outpatient clinic or physician’s office prior to
                                   hospital admittance and the appropriate code is used. However,
                                   treatment initiated in a hospital emergency room is not separately
                                   reimbursable as it is included in the hospital reimbursement, regardless
                                   of whether the hospital is a contract or non-contract hospital.


Investigational Services           Investigational services (such as I.V. thrombolytics) other than
                                   streptokinase or alteplase are not Medi-Cal covered and are considered
                                   for authorization only under special circumstances by a Medi-Cal
                                   physician consultant.




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Therapeutic Injection              Therapeutic injections are billed with CPT-4 codes 96369  96379.
Benefits


Required Codes                     CPT-4 codes 96370 and 96371 must be billed with primary procedure
                                   code 96369.


Billing                            Providers may bill for CPT-4 code 96375 in conjunction with codes
                                   96365, 96374, 96409 and 96413. CPT-4 code 96379 requires a TAR.



Thyrotropin Alfa                   Thyrotropin alfa is reimbursable for use in the following groups:
(Thyrogen)                         (1) as a diagnostic tool for serum thyroglobulin testing with or without
                                   radioiodine imaging in the follow-up of patients with well-differentiated
                                   thyroid cancer and (2) as an adjunctive treatment for radioiodine
                                   ablation of thyroid tissue remnants in patients who have undergone a
                                   near-total or total thyroidectomy for well-differentiated thyroid cancer
                                   and who do not have evidence of metastatic thyroid cancer.

Dosage                             A two-injection regimen is recommended. The two-injection regimen
                                   is thyrotropin alfa 0.9 mg intramuscularly (IM) followed by a second
                                   0.9 mg IM injection 24 hours later.

                                   For imaging or remnant ablation, radioiodine administration should
                                   be given 24 hours following the final thyrotropin alfa injection.
                                   A post-ablation scan should be performed three to five days after
                                   radioiodine administration. A diagnostic serum thyroglobulin with or
                                   without scanning should be performed 48 hours after radioiodine
                                   administration.


Authorization                      An approved Treatment Authorization Request (TAR) is required for
                                   reimbursement.


Billing                            HCPCS code J3240 injection, thyrotropin alpha, 0.9 mg, provided in
                                   1.1 mg vial.




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                          ®
Tigecycline (Tygacil )             Tigecycline, 1 mg (HCPCS code J3243) has a maximum daily dosage
                                   of 100 mg.



Tinzaparin Sodium                  Tinzaparin sodium 1000 IU/cc (HCPCS code X5509) is used in the
        ®
(Innohep )                         treatment of deep vein thrombosis and can be administered as a
                                   subcutaneous injection on an outpatient basis. When tinzaparin
                                   sodium is administered to an inpatient, the reimbursement is included
                                   in the hospital’s negotiated contract rate and is therefore not
                                   separately reimbursable.


Billing                            Providers should bill a quantity of “1” when any amount (up to 1000 IU)
                                   is injected. For example: If 1000 IU are given, then 1 unit is billed and
                                   if 3500 IU are given, 4 units are billed.



Treprostinil                       Treprostinil, 1 mg, (HCPCS code J3285) is reimbursable for patients
             ®
(Remodulin )                       16 years of age or older with pulmonary hypertension. Claims require
                                   authorization.




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Vancomycin                         Vancomycin is a glycopeptide antibiotic that is reimbursable when
                                   used for the treatment of serious or severe infections caused by
                                   susceptible strains of gram positive bacteria.

Dosage                             The initial intravenous dose should be based on actual body weight;
                                   with subsequent dosing based on serum trough vancomycin
                                   concentrations.

Billing                            HCPCS code
                                   J3370 Injection, vancomycin HCL, 500 mg
                                   One (1) unit = 500 mg



                            ®
Verteporfin (Visudyne )            Verteporfin 0.1 mg injection (HCPCS code J3396) is used in
                                   conjunction with retinal photodynamic therapy (CPT-4 code 67221)
                                   and must be billed in conjunction with ICD-9-CM code 362.52
                                   (exudative senile macular degeneration). Providers must document in
                                   the Remarks field (Box 80)/Reserved for Local Use field (Box 19) of
                                   the claim both the Body Surface Area (BSA) of the recipient and the
                                   dose administered.
                                   Verteporfin is supplied in vials of 15 mg and must be used within four
                                   hours of being opened.


Billing                            Providers must bill code J3396 in quantities of either 150 or 300.
                                   Note:   Since the Quantity field on the UB-04 claim is limited to two
                                           digits, providers will need to bill using multiple lines on the
                                           same claim. The total quantity billed must equal either 150 or
                                           300.



Vitamin B-12                       Vitamin B-12 injection is billed with HCPCS code X5752.


Required Codes                     Code X5752 must be billed in conjunction with one or two of the
                                   following ICD-9 codes documented in the Diagnosis field of the claim:
                                      123.4       281.9       357.5         555.1         579.1
                                      266.2       336.2       357.6         555.2         579.2
                                      281.0       357.0       357.7         555.9         579.3
                                      281.1       357.1       357.8         556.1         579.4
                                      281.2       357.2       357.89        564.2         579.9
                                      281.3       357.3       357.9         577.8         648.2
                                      281.4       357.4       555.0         579.0         782.0
                                      281.8




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                           ®
Ziprasidone (Geodon )              Ziprasidone is reimbursable for acute and long-term treatment of
                                   adult schizophrenia.

                                   Ziprasidone has been shown to be effective for the acute and
                                   long-term management of agitation experienced by patients with
                                   schizophrenia.
                                   Note: There is a Food and Drug Administration warning on
                                         ziprasidone about its greater capacity to prolong the QT/QTc
                                         intervals as opposed to other antipsychotic drugs. Prolongation
                                         of the QTc interval has been associated with the development
                                         of a potentially fatal condition of ventricular tachycardia and
                                         sudden death.


Required Codes                     Ziprasidone is reimbursable to the maximum U/V/S of four units when
                                   billed in conjunction with one of the following ICD-9-CM diagnosis
                                   codes: 295.3, 295.4 or 295.8.



Billing                            For billing ziprasidone, 20 mg injection, use HCPCS code X7498.




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                               ®
Zoledronic Acid (Reclast )         Zoledronic acid is indicated for the treatment of osteoporosis
                                   in postmenopausal women, prevention of osteoporosis in postmenopausal
                                   women, treatment to increase bone mass in men with osteoporosis,
                                   treatment and prevention of glucocorticoid-induced osteoporosis in patients
                                   expected to be on glucocorticoids for at least 12 months, and the treatment
                                   of Paget’s disease of bone in men and women.


Required Codes                     Code J3488 is reimbursable when billed in conjunction with the following
                                   diagnosis codes:

                                   ICD-9-CM Code        Description
                                   256.2                Postablative ovarian failure
                                   256.31               Premature menopause
                                   627.0 – 627.9        Menopausal and postmenopausal disorders
                                   731.0                Osteitis deformans without mention of bone tumor
                                   733.0 – 733.09       Osteoporosis
                                   V07.4                Hormone replacement therapy (postmenopausal)
                                   V49.81               Asymptomatic postmenopausal status
                                                        (age-related) (natural)



Billing                            For billing zoledornic acid, 1 mg, use HCPCS code J3488. Coverage is
                                   limited to one 5 mg injection, once in 12 months.




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Zoledronic Acid (Zometa)           Zoledronic acid is reimbursable for the treatment of hypercalcemia
                                   associated with malignancy, multiple myeloma, and documented
                                   bone metastases from solid tumors, in conjunction with standard
                                   anti-neoplastic therapy. Zoledronic acid is also reimbursable for
                                   the prevention of androgen deprivation-induced bone loss in
                                   non-metastatic prostate cancer.


Dosage                             The usual dose is 4 mg as a single dose intravenous infusion.


Required Codes                     Appropriate ICD-9-CM codes include 185, 203.00, 203.01, 203.02 or
                                   275.42, and any other code that specifically describes a solid tumor.


Billing                            HCPCS code J3487 Injection, zoledronic acid (Zometa), 1 mg




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Description: Injections Drugs M Z Policy inject drug m z Sodium Hyaluronate