This guide provides general information on how to prepare claims for Medicare patients who have been prescribed PERFOROMIST®. Each office remains responsible for properly submitting all claims for medically appropriate patients who have coverage under their Medicare Part B medical benefit.
Information Guide for how to Prescribe PERFOROMIST (formoterol fumarate) Inhalation Solution
Refer to CMS regulations and guidance and applicable MAC documentation requirements.
ICD-10 Diagnosis codes appropriate for PERFOROMIST Inhalation Solution†
Check Medicare Part B documentation requirements are met prior to submitting claims
Make sure your files include complete and accurate records before submitting a claim for PERFOROMIST or a nebulizer12
Refer to CMS regulations and guidance and applicable MAC documentation requirements.
- The prescription (order) should be sufficiently detailed and can be relied on for coverage determination12, 13 (For example, a written prescription that includes a diagnosis code and “For home use—Part B” is sufficient documentation of the use and setting of the drug for Part B coverage)6
- You must have a detailed written order (DWO) on file before you submit the claim12
- Your file must also include detailed medical records supporting that the inhalation solution and nebulizer are medically necessary, and that they continue to be needed and used by the beneficiary12
- Before submitting a claim for a nebulizer, be sure that your records include documentation of a face-to-face evaluation within 6 months prior to the date of the prescription12
- When submitting claims to the DME MAC, ensure proper ICD-10-CM code(s), place of service (POS) code, and HCPCS codes and modifiers are entered10, 11
- Medicare claims must be submitted electronically (837P format) unless the supplier qualifies for a waiver or exception in which case a paper claim (CMS 1500) is allowed10; both electronic and paper claims must contain the required patient information and supporting clinical documentation
- Be sure to file claims no later than 12 months after the date of service10
CMS=Centers for Medicare & Medicaid Services; HCPCS=Healthcare Common Procedure Coding System; MAC=Medicare Administrative Contractor.
Rules for submitting claims to Medicare Advantage (MA) plans generally align with Medicare guidelines
Remember, claims billed to MA plans are submitted directly to the individual plan, not to a DME MAC10
Refer to individual plans to verify coverage and documentation requirements.
- Similar to Medicare, MA plans may require a valid prescription including the prescriber’s NPI
- Some MA plans may require additional documentation verifying the medical necessity of PERFOROMIST and a nebulizer
- Be sure to use proper coding (eg, ICD-10-CM diagnosis code, POS code, and HCPCS codes and modifiers as applicable)
- MA plans may require documentation verifying the use of PERFOROMIST in the home setting
- Check for the correct BIN/PCN combination in order to process the claim appropriately for the individual plan
- For members with MA-PD plans, improper billing of a Part B drug to the Part D benefit may sometimes result in rejection with instructions to bill the Part B carrier
- Some plans may require electronic claim submission (using the 837 format); others may allow paper claims (eg, CMS 1500); submission deadlines may differ among individual plans
MA claims are submitted to the individual plan—not to Medicare or a DME MAC.10 Be sure to use proper coding to facilitate the transaction.
BIN=bank identification number; NPI=National Provider Identifier; PCN=processor control number; PD=prescription drug.
Commercial plans vary in their requirements for filing claims, but generally they align with Medicare
Be sure to check with the individual plan to verify coverage and documentation requirements
- For commercial plans, claims must include the NDC for prescription drugs, including nebulized inhalation medications
- For a carton of 30 individually wrapped unit dose vials of PERFOROMIST,
the NDC is
- Some plans may allow another acceptable form of prescriber identifier in lieu of an NPI
- Claims may require the 2-digit person code (which is not required by Medicare)
- Be sure to use the correct BIN/PCN combination; claims for a nebulizer may be processed under the plan’s medical benefit, whereas claims for PERFOROMIST may be processed by a separate pharmacy benefit manager
- Ensure proper ICD-10-CM diagnosis code(s); person code (2-digit entry code); NDC for PERFOROMIST; and HCPCS codes and appropriate modifiers
- Some plans may require electronic claim submission (using the 837 format) while some may allow submission via paper claim form (eg, CMS-1500); submission deadlines may differ among individual plans
Patients may have separate insurance cards for their health plan and prescription drug plan. Be sure to obtain all the necessary information before submitting a claim for PERFOROMIST or the nebulizer.
†Other codes may apply. The prescribing physician should select the appropriate code based on each individual patient's diagnosis.
Make sure your files include complete and accurate records before submitting a claim for PERFOROMIST
Important Safety Information
Contraindications: Use of a LABA, including PERFOROMIST, without an inhaled corticosteroid is contraindicated in patients with asthma. PERFOROMIST is not indicated for the treatment of asthma.
Serious Asthma-Related Events: Use of long-acting beta2-adrenergic agonists (LABA) as monotherapy [without inhaled corticosteroids (ICS)] for asthma is associated with an increased risk of asthma-related death. Available data from controlled clinical trials also suggest that use of LABA as monotherapy increases the risk of asthma-related hospitalization in pediatric and adolescent patients. These findings are considered a class effect of LABA monotherapy. When LABA are used in fixed-dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS alone. Available data do not suggest an increased risk of death with use of LABA in patients with COPD.
Deterioration of Disease and Acute Episodes: PERFOROMIST Inhalation Solution should not be initiated in patients with acutely deteriorating COPD, which may be a life-threatening condition. PERFOROMIST Inhalation Solution should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm.
Excessive Use and Use with Other LABAs: PERFOROMIST Inhalation Solution should not be used more often, at higher doses than recommended, or in conjunction with other inhaled, long-acting beta2-agonists, as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs.
Paradoxical Bronchospasm: As with other inhaled beta2-agonists, PERFOROMIST Inhalation Solution can produce paradoxical bronchospasm that may be life threatening. If paradoxical bronchospasm occurs, PERFOROMIST Inhalation Solution should be discontinued immediately and alternative therapy instituted.
Cardiovascular Effects: PERFOROMIST Inhalation Solution, like other beta2-agonists, can produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, systolic and/or diastolic blood pressure, and/or symptoms. PERFOROMIST Inhalation Solution should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias and hypertension.
Coexisting Conditions: PERFOROMIST Inhalation Solution, like other sympathomimetic amines, should be used with caution, especially in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to sympathomimetic amines. Doses of the related beta2-agonist albuterol, when administered intravenously, have been reported to aggravate preexisting diabetes mellitus and ketoacidosis.
Hypokalemia and Hyperglycemia: Beta-agonist medications may produce significant hypokalemia in some patients, which has the potential to produce adverse cardiovascular effects. The decrease in serum potassium is usually transient, not requiring supplementation. Beta-agonists can produce transient hyperglycemia.
Immediate Hypersensitivity Reactions: Immediate hypersensitivity reactions may occur after administration of PERFOROMIST Inhalation Solution, as demonstrated by cases of anaphylactic reactions, urticaria, angioedema, rash, and bronchospasm.
Use in Special Populations: PERFOROMIST Inhalation Solution, as with other beta2-agonists, should be used with extreme caution in patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval because the action of adrenergic agonists on the cardiovascular system may be potentiated by these agents.
Drug Interactions: Beta-blockers and formoterol fumarate may inhibit the effect of each other when administered concurrently. Therefore, patients with COPD should not normally be treated with beta-blockers except under certain circumstances e.g., as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-blockers in patients with COPD.
Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate any hypokalemic effect of adrenergic agonists. The EKG changes and/or hypokalemia that may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, so caution is advised in the coadministration.
Most Common Adverse Reactions: The most common adverse reactions (≥2% and more common than placebo) with PERFOROMIST are diarrhea, nausea, nasopharyngitis, dry mouth, vomiting, dizziness, and insomnia.
PERFOROMIST® (formoterol fumarate) Inhalation Solution is indicated for the long-term, twice-daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
Important Limitations for Use:
- It is not indicated to treat acute deteriorations of COPD.
- It is not indicated to treat asthma. The safety and effectiveness of PERFOROMIST Inhalation Solution in asthma has not been established.
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