Ohio Admin. Code 5160-10-06 - DMEPOS: wearable cardioverter-defibrillators
(A)
Prescribing
provider. Only a physician experienced in the management of patients at risk
for sudden cardiac death (SCD), such as a cardiologist, electrophysiologist, or
cardiac surgeon, may prescribe a wearable cardioverter-defibrillator
(WCD).
(B)
Coverage.
(1)
Separate payment may be made for a WCD furnished to a
resident of a long-term care facility (LTCF).
(2)
Payment may be
made for a WCD on a rental basis only.
(3)
The default
certificate of medical necessity (CMN) is form ODM 10275, "Certificate of
Medical Necessity: Wearable Cardioverter-Defibrillators"
(9/2021).
(4)
A completed CMN confirms that the following criteria
are met:
(a)
The individual is at high risk of SCD, established by the
occurrence or presence of medically indicated factors including but not limited
to the following examples:
(i)
A documented episode of ventricular fibrillation or
sustained ventricular tachyarrhythmia lasting at least thirty seconds, either
spontaneous or induced during an electrophysiologic (EP) study but not
attributable to a transient or reversible cause and not occurring within the
first forty-eight hours after an acute myocardial infarction;
(ii)
Familial or
hereditary conditions with a high risk of life-threatening ventricular
tachyarrhythmia, such as long QT syndrome or hypertrophic cardiomyopathy;
or
(iii)
Recent myocardial infarction, dilated cardiomyopathy,
newly diagnosed non-ischemic cardiomyopathy, coronary artery bypass graft
(CABG), or percutaneous coronary intervention (PCI), with a left ventricular
ejection fraction (measured during either the acute or post-acute phase) of not
greater than thirty-five per cent; and
(b)
Treatment of the
individual with an implantable cardioverter-defibrillator (ICD) is precluded by
any of the following considerations:
(i)
A currently implanted ICD needs to be
explanted;
(ii)
An infection prevents initial implantation of an ICD;
or
(iii)
Some condition or circumstance, either temporary or
permanent, contraindicates ICD implantation surgery.
(c)
The individual is
able to wear a properly fitted WCD at least ninety per cent of the time (an
average total of at least twenty-one and a half hours per day).
(5)
A WCD
is generally covered for a period of ninety days at a time. Additional
ninety-day coverage periods may be authorized if the provider submits
documentation, such as a detailed statement signed by the treating physician
that the WCD continues to be medically necessity and the individual continues
to use it correctly. Authorization may be given for indefinite (lifetime)
coverage if the provider submits appropriate documentation, such as a detailed
statement signed by the treating physician and a description of the
circumstances that preclude future implantation of an ICD.
(6)
Rental payment
includes necessary replacement of batteries, electrodes, and the cover
garment.
Notes
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5164.02
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