Updated on: January 22, 2014

Drill Down: DME Providers: Automatic External Defibrillator Medical Necessity

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Original story posted on: January 20, 2014

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EDITOR’S NOTE: A major formatting error occurred in the  Drill Down article  posted on January 21, 2014,after paragraph 2. Here is the original article from Margaret Klasa. RACmonitor apologizes for the inconvenience.

Since my last regular Drill Down column in December 2013, RAC Region A contractor Performant posted a complex review type for DME providers in regards to Automatic External Defibrillators. At issue is that there seems to be a potential risk for inappropriate billing when claims for the Automatic External Defibrillators were billed without supporting Medical Necessity.  Per DME MAC Jurisdiction A contractor NHIC, the Local Coverage Determination (L13613) defines medical necessity as follows:

“Automatic external defibrillators are covered for beneficiaries at high risk for sudden cardiac death (SCD) due to one of the conditions described under I or II. It is expected the ordering physician be experienced in the management of beneficiaries at risk for SCD. 

  1. A wearable defibrillator (K0606) is covered for beneficiaries if they meet one of the criteria (1-4), described below:
    1. A documented episode of ventricular fibrillation or a sustained, lasting 30 seconds or longer, ventricular tachyarrhythmia. These dysrhythmias may be either spontaneous or induced during an electrophysiologic (EP) study, but may not be due to a transient or reversible cause and not occur during the first 48 hours of an acute myocardial infarction (ICD-9 427.1, 427.42, 427.5); or
    2. Familial or inherited conditions with a high risk of life-threatening ventricular tachyarrhythmia such as long QT syndrome (ICD-9 426.82) or hypertrophic cardiomyopathy (ICD-9 425.1); or
    3. Either documented prior myocardial infarction (ICD-9 410.00-410.92, 412) or dilated cardiomyopathy (ICD-9 425.0-425.9) and a measured left ventricular ejection fraction less than or equal to 0.35; or
    4. A previously implanted defibrillator now requires explantation (ICD-9 996.04, 996.61)
  2. A non-wearable automatic defibrillator (E0617) is covered for beneficiaries in two circumstances. They meet either (1) both criteria A and B or (2) criteria C, described below
  1. The beneficiary has one of the following conditions (1-8):
    1. A documented episode of cardiac arrest due to ventricular fibrillation, not due to a transient or reversible cause (ICD-9 427.41, 427.42, 427.5).
    2. A sustained, lasting 30 seconds or longer, ventricular tachyarrhythmia, either spontaneous or induced during an electrophysiologic (EP) study, not associated with acute myocardial infarction, and not due to a transient or reversible cause (ICD-9 427.1).
    3. Familial or inherited conditions with a high risk of life-threatening ventricular tachyarrythmias such as long QT syndrome (ICD-9 426.82) or hypertrophic cardiomyopathy (ICD-9 425.1).
    4. Coronary artery disease with a documented prior myocardial infarction, (ICD-9 410.00 – 410.92, 412) with a measured left ventricular ejection fraction less than or equal to 0.35, and inducible, sustained ventricular tachycardia (VT) or ventricular fibrillation (VF) during an EP study. To meet this criterion;
      1. The myocardial infarction must have occurred more than 4 weeks prior to the external defibrillator prescription; and, 
      2. The EP test must have been performed more than 4 weeks after the qualifying myocardial infarction.
    5. Documented prior myocardial infarction (ICD-9 410.00-410.92, 412) and a measured left ventricular ejection fraction less than or equal to 0.30. Beneficiaries must not have:
      1. Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm; or,
      2. Had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within past 3 months; or,
      3. Had an enzyme-positive MI within past month; or,
      4. Clinical symptoms or findings that would make them a candidate for coronary revascularization; or,
      5. Irreversible brain damage from preexisting cerebral disease; or,
      6. Any disease, other than cardiac disease (e.g. cancer, uremia, liver failure), associated with a likelihood of survival less than one year.
    6. Beneficiaries with ischemic dilated cardiomyopathy (IDCM), documented prior myocardial infarction (MI), New York Heart Association (NYHA) Class II and III heart failure, and measured left ventricular ejection fraction (LVEF) ≤ 35%.
    7. Beneficiaries with nonischemic dilated cardiomyopathy (NIDCM) > 3 months, NYHA Class II and III heart failure, and measured LVEF ≤ 35%.
    8. Beneficiaries who meet one of the previous criteria (1-7) and have NYHA Class IV heart failure.
  2. Implantation surgery is contraindicated.
  3. A previously implanted defibrillator now requires explantation (ICD-9 996.04, 996.61).

Claims for defibrillators for other indications will be denied as not reasonable and necessary.”

Documentation Requirements

All items billed to Medicare require a prescription, signed and dated by the treating physician and kept on file by the supplier.  If no prescription order is on file but the items are dispensed and or billed that do not meet the prescription requirements then modifier EY must be submitted with the affected HCPCS code on the claim.

Equipment may be delivered upon receipt of a dispensing order except those that require a written order prior to delivery. A dispensing order can be verbal or written and must be on file with the supplier.

In order for the defibrillator to be covered under Medicare a Detailed Written Order (DWO) must be received by the supplier before you submit the claim.  So if the supplier bills for this item before getting the (DWO) from the provider, this item will be denied for not meeting medical necessity.

RAC Issues for the Week of January 20 – January 24, 2014:

RAC Region A Performant

DME Supplier

  • Automatic External Defibrillators - Jurisdiction A - Potential incorrect billing occurred when claims for automatic external defibrillators were billed without an indication supporting Medical Necessity as described in the NHIC Local Coverage Determination (LCD) L13613 and related article (A23905).

RAC Region B CGI

DME

  • DME CPAP Without OSA Diagnosis—NGS DME MAC B - The use of a CPAP device is covered under Medicare for adult patients with a diagnosis of Obstructive Sleep Apnea (OSA) based upon clinical findings and an appropriate sleep test that meets the Medicare coverage criteria. Only the diagnosis OSA supports the medical necessity for a CPAP device.

Inpatient

  • Cancelled Elective Surgeries--OIG (Medical Necessity) - When an inpatient hospital admission is based on the expectation that a patient will have elective surgery, but that surgery does not occur, the hospital may bill for the admission only if it remains reasonable and necessary despite the surgery’s cancellation.

RAC Region D HDI

Outpatient Hospital

  • Rituximab (Rituxan), 100 mg - Dose vs. Units Billed – Prepayment - Rituximab (Rituxan), 100 mg (J9310) should be billed one (1) unit for every 100 mg per patient administered. Hospitals need to ensure that units of drugs administered to patients are accurately reported in terms of dosage specified in the full HCPCS code descriptor.
  • Trastuzumab (Herceptin), Multi-dose vial waste - Outpatient – Prepayment - Per its Package Label, Trastuzumab (Herceptin) is supplied by the manufacturer in a 440 mg multi-dose vial. Per Medicare Claims Processing Manual (100-04) Chapter 17, Section 40: "When a physician, hospital or other provider or supplier must discard the remainder of a single use vial or other single use package after administering a dose/quantity of the drug or biological to a Medicare patient, the program provides payment for the amount of drug or biological discarded as well as the dose administered, up to the amount of the drug or biological as indicated on the vial or package label...Note: Multi-use vials are not subject to payment for discarded amounts of drug or biological."

Professional Services (Physician/Non-Physician Practitioner)

Trastuzumab (Herceptin), Multi - dose vial waste – Prepayment - Per its Package Label, Trastuzumab (Herceptin) is supplied by the manufacturer in a 440 mg multi-dose vial. Per Medicare Claims Processing Manual (100-04) Chapter 17, Section 40: "When a physician, hospital or other provider or supplier must discard the remainder of a single use vial or other single use package after administering a dose/quantity of the drug or biological to a Medicare patient, the program provides payment for the amount of drug or biological discarded as well as the dose administered, up to the amount of the drug or biological as indicated on the vial or package label...Note: Multi-use vials are not subject to payment for discarded amounts of drug or biological."

Professional Services (Physician/Non-Physician Practitioner)

Trastuzumab (Herceptin), Multi - dose vial waste – Prepayment - Per its Package Label, Trastuzumab (Herceptin) is supplied by the manufacturer in a 440 mg multi-dose vial. Per Medicare Claims Processing Manual (100-04) Chapter 17, Section 40: "When a physician, hospital or other provider or supplier must discard the remainder of a single use vial or other single use package after administering a dose/quantity of the drug or biological to a Medicare patient, the program provides payment for the amount of drug or biological discarded as well as the dose administered, up to the amount of the drug or biological as indicated on the vial or package label...Note: Multi-use vials are not subject to payment for discarded

About the Author

Dr. Margaret Klasa is the medical director for Context4 Healthcare. She is responsible for the company’s business knowledge discovery unit for medical context as it relates to the daily development of data products and software for medical claims editing and coding, with an emphasis on clinical and regulatory guidelines for Medicare, Medicaid and commercial payers.

Contact the Author

Margaret.Klasa@context4.com

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Margaret Klasa, DC, APN, Bc

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