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The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case.
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101.
The rules say that medically necessary services are those that are reasonable and necessary for the diagnosis or
treatment of an illness or injury. Medically necessary services include services to improve the functioning of a
malformed body member. You can find this rule in the Social Security Act, Section 1862(a)(1)(A).
The rules say that services that are not medically necessary are not covered. The rules also say that
experimental and investigational devices are not covered. You can find this rule at 42 CFR Sections 411.15 and
411.15(o).
The Centers for Medicare & Medicaid Services (CMS) National Coverage Determinations Manual (Internet-
Only Manual, Publ. 100-03) in Chapter 1, Part 4, Section 280.1 stipulates that ventilators (E0465, E0466) are
covered for the following conditions:
"[N]euromuscular diseases, thoracic restrictive diseases, and chronic respiratory failure consequent to chronic
obstructive pulmonary disease."
Each of these disease categories are comprised of conditions that can vary from severe and life-threatening to
less serious forms. These ventilator-related disease groups overlap conditions described in this Respiratory
Assist Devices LCD used to determine coverage for bi-level PAP devices. Each of these disease categories are
conditions where the specific presentation of the disease can vary from patient to patient. For conditions such
as these, the specific treatment plan for any individual patient will vary as well. Choice of an appropriate
treatment plan, including the determination to use a ventilator vs. a bi-level PAP device, is made based upon
the specifics of each individual beneficiary's medical condition. In the event of a claim review, there must be
sufficient detailed information in the medical record to justify the treatment selected.
Ventilators fall under the Frequent and Substantial Servicing (FSS) payment category, and payment policy
requirements preclude FSS payment for devices used to deliver continuous and/or intermittent positive airway
pressure, regardless of the illness treated by the device. (Social Security Act 1834(a)(3)(A)) This means that
products currently classified as HCPCS code E0465 or E0466 when used to provide CPAP or bi-level PAP
(with or without backup rate) therapy, regardless of the underlying medical condition, shall not be paid in the
FSS payment category. A ventilator is not eligible for reimbursement for any of the conditions described in this
RAD LCD even though the ventilator equipment may have the capability of operating in a bi-level PAP
(E0470, E0471) mode. Claims for ventilators used to provide CPAP or bi-level CPAP therapy for conditions
described in this RAD policy will be denied as not reasonable and necessary.
General principles of correct coding require that products assigned to a specific HCPCS code only be billed
using the assigned code. Thus, using the HCPCS codes for CPAP (E0601) or bi-level PAP (E0470, E0471)
devices for a ventilator (E0465, E0466) used to provide CPAP or bi-level PAP therapy is incorrect coding.
Claims for ventilators billed using the CPAP or bi-level PAP device HCPCS codes will be denied as incorrect
coding.
You can find this information in the Local Coverage Determination (LCD): Respiratory Assist Devices
(L33800).
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com.
The Plan contract says that the Plan covers items and services in accordance with Medicare rules.