Zoledronic Acid Infusions _Reclast_

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					                                     Zoledronic Acid Infusions
                                       Approved diagnosis/ ICD-9 Codes:
      733.01                   Senile Osteoporosis (men and post-menopausal women)
      733.01 + 733.14          (patho) fracture: Neck of Femur
      733.01 + 733.15          (patho) fracture: Other specified part of Femur
      733.01 + 820.0-820.9 fracture due to injury: Neck of Femur
      733.09 + E932.06         Glucocorticoid induced Osteoporosis
      Primary dx code + V58.65 Prevention of glucocorticoid-induced osteoporosis
       733.90                  Disorders of Bone and Cartilage (Commercial Insurance only -BCBS/United
                               HealthCare/Cigna/NC State Health Plan covers Zoledronic Acid)
      731.0                    Paget’s disease of bone
      733.09                   Osteopenia or prevention indication (T-score 1.0-2.5 low bone mass)-infuse once
      every 2 years.
                                               Steps to follow:
  1.) MD must document the patient’s diagnosis in the chart.
      *Medicare requires documentation of medical necessity for infusion (including, but not limited to one
  of the following):
           the patient failed the first oral bisphosphonate or
           was GI intolerant ( severe esophageal disease, dysphagia); inability to take anything by mouth;
              inability to sit or stand for 30 minutes or intestinal malabsorption or
           noncompliant with oral bisphosphonates for at least 3 months.
           documented allergy to shellfish or salmon derivatives
      BCBS/United Health Care/Cigna/NC State Health Plan covers Zoledronic Acid first line
  2.) MD will give order for Zoledronic Acid infusion 5mg/100ml x1, to nurse.
  3.) Order will also be written for the patient to have labs done prior to receiving infusion. (Serum Calcium
      level must be within the normal range and calculated Creatinine clearance >35mL/min)-must be within
      2 months of the infusion.(If MD did not order labs, the nurse can write the lab order per Standing Order
      of Dr. Thomas Miller)
  4.) Nurse will give the order to Jasmine Levy, RN or Robin LaVerdure, LPN.
  5.) Jasmine or Robin will verify that the MD has charted the above information in the patient’s chart
      (WEBCIS). If it is not charted, the MD will be notified and asked to copy Jasmine or Robin with the
      completed information so they can go forward.
  6.) Jasmine or Robin will complete the necessary benefit verification forms and give them to Hilda (FC) to
      verify insurance coverage.
  7.) When the patient has been approved, Jasmine or Robin will call the patient to set up labs if not already
      done and set up infusion appointment.
  8.) After the infusion has been completed, the patient’s information will be placed in the “completed” book
      and updated on the Zoledronic Acid “Patient List” in WEBCIS to be contacted again next year for
      reinfusion. (Must be at least 366 days apart).
                                              Managed care coverage
  o Medicare Part B and Medicare/Medicaid dual eligible-must have documentation of non-compliance
or intolerance with oral biphosphonates. The MD MUST have this documented in the pt’s chart prior to
ordering the infusion.
  o Straight Medicaid patients are covered for All indications/diagnosis codes above. At most, the pt will
  pay $3.00.
  o If the patient is Medicare/ Medicaid (dual)-you know it is covered and nurses do not have to verify
  insurance coverage. The patient may have $3.00 co-pay. Patients with Medicare and a supplemental or
  secondary insurance plan may have low co-pay or none at all.
  o All patients under Medicare Advantage plans require a prior authorization.
  o Commercial Insurance patients- Zoledronic Acid can be prescribed first line for BCBS/United
  HealthCare/Cigna/NC State Health Plan.
  o Cash pay-(no insurance) can get patient assistance through Novartis.
                                        Per PI Warnings and Precautions
•       Patients receiving Zometa should NOT receive Zoledronic Acid (5.1)
•       Patients must be adequately supplemented with calcium and vitamin D (5.2)
•       A single dose should not exceed 5 mg and the duration of infusion should be no less than 15 minutes.
Renal toxicity may be greater in patients with underlying renal impairment or with other risk factors. Patients
with Creatinine clearance <35 mL/min should not receive Reclast. Monitor serum Creatinine before each dose
(2.1, 2.2, and 5.3)
•      Osteonecrosis of the jaw has been reported. All patients should have a routine oral exam by the prescriber
prior to treatment (5.4)
•      Atypical femur fractures have been reported. Patients with thigh or groin pain should be evaluated to rule
out a femoral fracture (5.5)
•      Reclast can cause fetal harm. Women of childbearing potential should be advised (5.6, 8.1)
•      Severe incapacitating bone, joint, and/or muscle pain may occur. Withhold future doses of Zoledronic
Acid if severe symptoms occur (5.7)
                                  UNC IM Zoledronic Acid Information Sheet
o Patient must have labs completed prior to day of infusion –preferred, but can be done on same day; this will
    add time to their appointment waiting on lab results and could possibly be changed based on results.
            Serum Calcium must be within normal limits
            Calculated Creatinine Clearance must be > to 35mL/min
o Patient should be taking adequate Calcium and Vitamin D supplements daily to prevent hypocalcaemia.
o Labs should be no more than two months old to be valid for infusion.
o Patient must be screened for previous Osteoporosis treatments. Give Zoledronic Acid at time of next
    bisphosphonate dose. Example: ibandronate sodium (Boniva): one month; alendronate sodium (Fosamax):
    one week
o There have been reports of bronchoconstriction in aspirin-sensitive patients receiving bisphosphonates,
    including Zoledronic Acid. Before being given Zoledronic Acid, patients should tell their doctor if they are
    aspirin-sensitive. Patient should pre-hydrate with two glasses of water and 1000mg of Acetaminophen.
o Each insurance company reimburses differently, these issues should be researched before any infusion is
o Zoledronic Acid and Zometa contain the same ingredient. Patients receiving Zometa should not receive
    Zoledronic Acid.
                                       Reclast Patient Information Guide:
     You may experience potential side effects: fever, tenderness or pain in muscles or joints, headache, flu-
        like symptoms, nausea, vomiting, diarrhea, and eye inflammation.
     These symptoms can be treated with 1000 mg acetaminophen (2 extra strength Tylenol) every eight
        hours as needed.
     If these symptoms do not resolve within three days contact your physician.
     Remember to hydrate on the day of infusion by drinking at least 2-8 ounce glasses of water and pre-treat
        with 1000 mg of acetaminophen before coming to your appointment.
     You should be taking two vitamin supplements:
             o 1000 – 1500 mg daily of Calcium
             o 800 – 1000 IU daily of Vitamin D
     There is no need to change any daily habits related to eating or exercise.

Created by R. LaVerdure 7-11-2011