External Counterpulsation (ECP) is a non-invasive outpatient treatment for coronary artery disease refractory to medical and/or surgical therapy. The patient is placed on a treatment table where their lower extremities are wrapped in a series of three compressive cuffs that inflate and deflate in synchronization with the patient’s cardiac cycle.
During diastole, the three sets of air cuffs are inflated sequentially (distal to proximal), compressing the vascular beds within the muscles of the calves, lower thighs and upper thighs. The action results in an increase in diastolic pressure, generation of retrograde arterial blood flow and an increase in venous return. The cuffs are deflated simultaneously just prior to systole, producing a rapid drop in vascular impedance, a decrease in ventricular workload and an increase in cardiac output.
Similar devices are cleared by the FDA for use in treating a variety of conditions, including stable or unstable angina pectoris, acute myocardial infarction and cardiogenic shock. Medicare coverage is limited to its use in patients with stable angina pectoris.
Coverage is provided for the use of ECP for patients who have been diagnosed with disabling angina (Class III or IV, Canadian Cardiovascular Society Classification or equivalent classification) who, in the opinion of a cardiologist or cardiothoracic surgeon, are not readily amenable to surgical intervention, such as Percutanerous Transluminal Coronary Angioplasty (PTCA) or cardiac bypass, because:
- Their condition is inoperable, or at high risk of operative complications or post-operative failure.
- Their coronary anatomy is not readily amenable to such procedures.
- They have co-morbid states that create excessive risk.
Coverage is further limited to those enhanced external counterpulsation systems that have sufficiently demonstrated their medical effectiveness in treating patients with severe angina in well designed clinical trials. A 510(k) Clearance by the Food and Drug Administration does not, by itself, satisfy this requirement.
This procedure must be performed under the direct supervision of a physician.
The use of the hydraulic version of these types of devices has been and will remain non-covered.
Notice: This LCD imposes diagnosis limitations that support diagnosis to procedure code automated denials. However, services performed for any given diagnosis must meet all of the indications and limitations stated in this policy, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.
As published in CMS IOM 100-08, Section 13.5.1, to be covered under Medicare, a service shall be reasonable and necessary. When appropriate, contractors shall describe the circumstances under which the proposed LCD for the service is considered reasonable and necessary under Section 1862(a)(1)(A). Contractors shall consider a service to be reasonable and necessary if the contractor determines that the service is:
- Safe and effective.
- Not experimental or investigational (exception: routine costs of qualifying clinical trial services with dates of service on or after September 19, 2000, which meet the requirements of the clinical trials NCD are considered reasonable and necessary).
- Appropriate, including the duration and frequency that is considered appropriate for the service, in terms of whether it is:
- Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function of a malformed body member.
- Furnished in a setting appropriate to the patient’s medical needs and condition.
- Ordered and furnished by qualified personnel.
- One that meets, but does not exceed, the patient’s medical need.
- At least as beneficial as an existing and available medically appropriate alternative.
Bill Type Codes
Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.
12X, 13X, 71X, 73X, 77X, 85X
Bill Type Note (above): Code 73X end-dated for Medicare use March 31, 2010; code 77X effective for dates of service on or after April 1, 2010.
Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.
Note: TrailBlazer has identified the Bill Type and Revenue Codes applicable for use with the CPT/HCPCS codes included in this LCD. Providers are reminded that not all CPT/HCPCS codes listed can be billed with all Bill Type and/or Revenue Codes listed. CPT/HCPCS codes are required to be billed with specific Bill Type and Revenue Codes. Providers are encouraged to refer to the CMS Internet-Only Manual (IOM) Pub. 100-04, Claims Processing Manual, for further guidance.
Providers are reminded to refer to the long descriptors of the CPT codes in their CPT book. The American Medical Association (AMA) and the Centers for Medicare & Medicaid Services (CMS) require the use of short CPT descriptors in policies published on the Web.
External counterpulsation, per treatment session
ICD-9-CM Codes That Support Medical Necessity
The CPT/HCPCS codes included in this LCD will be subjected to “procedure to diagnosis” editing. The following lists include only those diagnoses for which the identified CPT/HCPCS procedures are covered. If a covered diagnosis is not on the claim, the edit will automatically deny the service as not medically necessary.
Medicare is establishing the following limited coverage for CPT/HCPCS code G0166:
Other and unspecified angina pectoris
Note: Providers should continue to submit ICD-9-CM diagnosis codes without decimals on their claim forms and electronic claims.
Diagnoses That Support Medical Necessity
ICD-9-CM Codes That DO NOT Support Medical Necessity
Diagnoses That DO NOT Support Medical Necessity
All diagnoses not listed in the “ICD-9-CM Codes That Support Medical Necessity” section of this LCD.
Documentation supporting medical necessity should be legible, maintained in the patient’s medical record and made available to Medicare upon request.
A full course of therapy usually consists of 35 one-hour treatments, which may be offered once or twice daily, usually five days per week.
Evidence has been presented that the beneficial effect of this treatment lasted well beyond the immediate post-treatment phase. A course of ECP cannot be repeated within 24 months of the previous course without submission of information supporting medical necessity for the repeat course.
Notice: This LCD imposes utilization guideline limitations. Despite Medicare’s allowing up to these maximums, each patient’s condition and response to treatment must medically warrant the number of services reported for payment. Medicare requires the medical necessity for each service reported to be clearly demonstrated in the patient’s medical record. Medicare expects that patients will not routinely require the maximum allowable number of services.
Sources of Information and Basis for Decision
J4 (CO, NM, OK, TX) MAC Integration
TrailBlazer adopted the Arkansas BlueCross BlueShield (Pinnacle) LCD, “External Counterpulsion (ECP)”, for the Jurisdiction 4 (J4) MAC transition.
Full disclosure of sources of information is found with original contractor LCDs.
Why is the cost of enhanced external counter pulsation such a secret? I can find nothing on the cost to patients of the procedure anywhere.