Local Coverage Determination (LCD)

Percutaneous Coronary Interventions

L34761

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Proposed LCD
Proposed LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Proposed LCDs are not necessarily a reflection of the current policies or practices of the contractor.

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Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L34761
Original ICD-9 LCD ID
Not Applicable
LCD Title
Percutaneous Coronary Interventions
Proposed LCD in Comment Period
N/A
Source Proposed LCD
N/A
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 12/28/2023
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
N/A
Notice Period End Date
N/A

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Issue

Issue Description

Review completed with no change in coverage.

Issue - Explanation of Change Between Proposed LCD and Final LCD

CMS National Coverage Policy

Italicized font represents CMS national language/wording copied directly from CMS Manuals or CMS transmittals. Contractors are prohibited from changing national language.

CMS Pub 100-03, Medicare National Coverage Determination (NCD) Manual, Chapter 1- Coverage Determinations, Section 20.7 - Percutaneous Transluminal Angioplasty (PTA).

CMS Pub 100-04 Medicare Claims Processing Manual, Chapter 4 – Part B Hospital (Including Inpatient Hospital Part B and OPPS), Section 61.5 - Billing for Intracoronary Stent Placement.

CMS Pub 100-04 Medicare Claims Processing Manual, Chapter 13 – Radiology Services and Other Diagnosis Procedures, Section 20 - Payment Conditions for Radiology Services.




Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

Overview

Percutaneous coronary intervention (PCI), commonly known as coronary angioplasty or simply angioplasty, is a non-surgical procedure used to treat the stenotic (narrowed) coronary arteries of the heart found in coronary heart disease. These stenotic segments are due to the buildup of the cholesterol-laden plaques that form due to atherosclerosis. During PCI, a cardiologist feeds a deflated balloon or other device on a catheter from the inguinal femoral artery or radial artery up through blood vessels until they reach the site of blockage in the heart. X-ray imaging is used to guide the catheter threading. At the blockage, the balloon is inflated to open the artery, allowing blood to flow. A stent is often placed at the site of blockage to permanently open the artery.

Percutaneous transluminal coronary angioplasty (PTCA) is a minimally invasive procedure to open blocked coronary arteries, allowing blood to circulate unobstructed to the heart muscle.

Indications:
Percutaneous coronary intervention (PCI) may be indicated in the management of patients with:

  • acute coronary syndrome (e.g., acute myocardial infarction, unstable angina);
  • a history of significant obstructive atherosclerotic disease;
  • restenosis of a coronary artery previously treated with intracoronary stent or another revascularization procedure;
  • chronic angina; or
  • silent ischemia

Intracoronary ultrasound (IVUS) may be separately covered when needed to assess the extent of coronary stenosis if equivocal on angiography, or when needed to assess the patency and integrity of a coronary artery during percutaneous coronary intervention. Alternatively, intravascular Doppler velocity and/or pressure derived coronary flow reserve measurement may be performed to assess the degree of stenosis within a vessel. Intracoronary ultrasound or fractional flow reserve measurement should be performed on an individual artery as clinically indicated. Both procedures are not considered medically necessary unless written documentation is submitted to support medical necessity. Intracoronary ultrasound and Doppler fractional flow reserve studies can be required in multivessel coronary artery disease (CAD).

A diagnostic cardiac catheterization to assess the nature of the lesion(s) prior to the intervention is a covered service. The diagnostic cardiac catheterization may be performed at any time prior to the PCI, including the same day as the PCI. Performance of a diagnostic cardiac catheterization and interventional procedure on the same day is increasingly the standard of practice. If the diagnostic catheterization is done within 30 days of the PCI, it is usually not necessary to repeat the catheterization unless there is a documented change in the patient’s condition. While there may be reasons for delaying the interventional procedure (e.g., transfer from a community hospital to a tertiary center, excessive dye load, further treatment planning or evaluation of angiography, etc.), it is recommended that both procedures be performed during the same encounter when medically appropriate, with detailed discussion of benefits and risks of PCI. Separation of these procedures for the purpose of circumventing the multiple surgery pricing, or for the convenience of physician or hospital scheduling, is considered an inappropriate practice and may subject the services to review and denial for medical necessity. The decision to stage these procedures is deferred to the judgment of the interventional cardiologist and individualized only to the clinical needs of the patient. (e.g., dye load already received; need to correlate findings with other test results, etc.). Reasons for delaying an indicated percutaneous coronary intervention should be documented in the medical record. Unless there is a new clinical event, a change in symptomatology, abnormal examination or other test results, a repeat diagnostic catheterization within three months of the last diagnostic catheterization and prior to the percutaneous coronary intervention is generally not reimbursable and is considered not reasonable and necessary.

Limitations:
Generally, PCI is not indicated for:

  1. Patients that can be managed medically.
  2. Right heart catheterization and insertion of a Swan - Ganz catheter are not generally medically necessary for a PCI and will be denied, unless medically necessary when performed incident to a diagnostic catheterization prior to the intervention.
  3. Standby services of a surgeon or anesthesiologist are not covered services.
  4. Patient with stable CAD.
Summary of Evidence

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Analysis of Evidence (Rationale for Determination)

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Proposed Process Information

Synopsis of Changes
Changes Fields Changed
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Associated Information
Sources of Information
Bibliography
Open Meetings
Meeting Date Meeting States Meeting Information
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Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
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MAC Meeting Information URLs
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Proposed LCD Posting Date
Comment Period Start Date
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Reason for Proposed LCD
Requestor Information
This request was MAC initiated.
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Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code Description

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Revenue Codes

Code Description

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CPT/HCPCS Codes

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ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph:

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Group 1 Codes:

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ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

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Group 1 Codes:

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Additional ICD-10 Information

General Information

Associated Information

Documentation Requirements
The patient’s medical record must contain documentation that fully supports the medical necessity for coverage as stated in the Indications, Limitations, and/or Medical Necessity section of the policy. This documentation includes but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures. There should be a permanent record of the procedure. The documentation should include a description of the procedure(s) performed and any contrast media, medications, catheters, stents, or devices used. Any known significant patient reaction or complication should be recorded. Comparison with prior relevant studies or procedure(s) needs to be addressed in the documentation. The report should address or answer any specific clinical questions or findings. If there are factors that prevent answering the clinical questions, this should be explained in the documentation. If there are factors that prevent the completion of the procedure, this should be explained in the documentation. Retention of angiographic documentation (film or digital) as well as intravascular sonographic recording(s) should be consistent both with clinical need and with relevant legal and local health care facility requirements.

If the provider performing the procedure is other than the ordering/referring physician/nonphysician practitioner, that provider must maintain a copy of the procedure report and interpretation, along with copies of the ordering/referring physician/nonphysician practitioner’s order for the procedure. The physician/nonphysician practitioner must state the clinical indication/medical necessity for the procedure in his/her order for the procedure. Results of all procedures must be shared with the referring physician.

Each claim must be submitted with diagnosis codes that reflect the condition of the patient and indicate the reason(s) for which the test was performed. Note: A payable diagnosis alone does not support medical necessity of ANY service.

The medical record must include documentation of the need for repeat diagnostic angiography when previously performed, in the absence of any new clinical symptoms or signs of disease progression, within the preceding three months.

All documentation must be maintained in the patient’s medical record and made available to Medicare upon request.

The HCPCS/CPT code(s) may be subject to Correct Coding Initiative (CCI) edits. This policy does not take precedence over CCI edits. Please refer to the CCI for correct coding guidelines and specific applicable code combinations prior to billing Medicare.

When the documentation does not meet the criteria for the service rendered or the documentation does not establish the medical necessity for the services, such services will be denied as “not reasonable and necessary” under Section 1862(a)(1) of the Social Security Act.

Utilization Guidelines
It is expected that these services would be performed as indicated by current medical literature and/or standards of practice for the patient’s condition. PCI testing which exceeds the frequency or duration indicated by the accepted standards of medical practice are not covered unless there are special circumstances which justify the medical necessity for the additional PCI. The routine and repetitive monitoring of patients in the absence of a documented change in condition (i.e., new symptoms or progression of existing symptoms) is not considered medically necessary.

An overnight inpatient stay is not anticipated for routine recovery of a PCI procedure and should not be billed as inpatient services. The routine recovery period should not be billed as observation hours in addition to the PCI unless the patient has sustained untoward complications necessitating the continued monitoring. An inpatient stay following a routine PCI would not be considered medically necessary. It is important to submit written documentation of complications or additional concerns about risk factors for those who have inpatient admission or observation after PCI.

Preventive and/or screening services unless covered in Statute are not covered by Medicare.

Sources of Information
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Bibliography
  1. Amsterdam EA, Wenger NK. The 2014 American College of Cardiology ACC/American Heart Association guideline for the management of patients with non-st-elevation acute coronary syndromes. Clinical Cardiology. 2015;38(2):121-123.
  2. Anderson HV, Shaw RE, Brindis RG, et al. Relationship between procedure indications and outcomes of percutaneous coronary interventions by American College of Cardiology/American Heart Association Task Force Guidelines. Circulation. 2005;112(18):2786-2791.
  3. Angiolillo DJ, Bass TA. Percutaneous coronary interventions in st-segment–elevation myocardial infarction. Circulation: Cardiovascular Interventions. 2013;6(6):593-595.
  4. Blankenship JC, Gigliotti OS, Feldman DN, et al. Ad hoc percutaneous coronary intervention: A consensus statement from the Society for Cardiovascular Angiography and Interventions. Catheterization and Cardiovascular Interventions. 2012;81(5):748-758.
  5. Boden WE, O’Rourke RA, Teo KK. Optimal Medical therapy with or without PCI for stable coronary disease. The New England Journal of Medicine. 2007; 356:1503-1516.
  6. Chambers CE, Dehmer GJ, Cox DA, et al. Defining the length of stay following percutaneous coronary intervention. Catheterization and Cardiovascular Interventions. 2009;73(7):847-858.
  7. Farkouh ME, Domanski M, Sleeper LA, et al. Strategies for multivessel revascularization in patients with diabetes. New England Journal of Medicine. 2012;367(25):2375-2384.
  8. Hillis LD, Smith PK, Anderson JL, et al. 2011 ACCF/AHA guideline for coronary artery bypass graft surgery. Circulation. 2011;124(23).
  9. Levine GN, Bates ER, Blankenship JC, et al. 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention. Circulation. 2011;124(23):574-651.
  10. Magnuson EA, Farkouh ME, Fuster V, et al. Cost-effectiveness of percutaneous coronary intervention with drug eluting stents versus bypass surgery for patients with diabetes mellitus and multivessel coronary artery disease. Circulation. 2013;127(7):820-831.
  11. Medical Advisory Secretariat. Intravascular ultrasound to guide percutaneous coronary interventions: an evidence-based analysis. Ont Health Technol Assess Ser. 2006;6(12):1-97.
  12. O’Gara PT, et al. 2013 ACCF/AHA guideline for the management of st-elevation myocardial infarction. Circulation. 2012;127(4):362-425.
  13. Park S-J, Ahn J-M, Kang S-J. Paradigm shift to functional angioplasty. Circulation. 2011;124(8):951-957.
  14. Patel MR, Bailey SR, Bonow RO, et al.
    ACCF/SCAI/AATS/AHA/ASE/ASNC/HFSA/HRS/SCCM/SCCT/SCMR/STS 2012 appropriate use criteria for diagnostic catheterization: a report of the American College of Cardiology Foundation Appropriate Use Criteria Task Force, Society for Cardiovascular Angiography and Interventions, American Association for Thoracic Surgery, American Heart Association, American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Failure Society of America, Heart Rhythm Society, Society of Critical Care Medicine, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2012;59(22):1995-2027.
  15. Patel MR, Dehmer GJ, et al. ACCF/SCAI/STS/AATS/AHA/ASNC 2009 appropriateness criteria for coronary revascularization. Circulation. 2009;119(9):1330-1352.
  16. Peterson ED, Dai D, DeLong ER, et al. Contemporary mortality risk prediction for percutaneous coronary intervention: results from 588,398 procedures in the National Cardiovascular Data Registry. J Am Coll Cardiol. 2010;55(18):1923-1932.
  17. Shaw LJ, Berman DS, Maron DJ, et al. Optimal medical therapy with or without percutaneous coronary intervention to reduce ischemic burden: results from the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial nuclear substudy. Circulation. 2008;117(10):1283-1291.
  18. Smith SC, Dove JT, Jacobs AK, et al. ACC/AHA Guidelines for percutaneous coronary intervention (revision of the 1993 PTCA guidelines)—executive summary. Circulation. 2001;103(24):3019-3041.

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
12/28/2023 R12

Posted 12/28/2023 Review completed with no change in coverage. Numbering added to Bibliography sources.

  • Other (Review)
12/30/2021 R11

12/30/2021 Review completed 10/13/2021. Sources of Information moved to Bibliography and format updated. Minor grammatical errors corrected.

  • Other (Compliance with CR 10901)
10/31/2019 R10

10/31/2019 Change Request 10901 Local Coverage Determinations (LCDs): it will no longer be appropriate to include Current Procedure Terminology (CPT)/Health Care Procedure Coding System (HCPCS) codes or International Classification of Diseases Tenth Revision-Clinical Modification (ICD-10-CM) codes in the LCDs. All CPT/HCPCS, ICD-10 codes, and Billing and Coding Guidelines have been removed from this LCD and placed in Billing and Coding: Percutaneous Coronary Interventions article linked to this LCD. Review done 10/11/2019. 

  • Other (Compliance with CR 10901)
03/01/2018 R9

03/01/2018 Annual review done 02/02/2018. Punctuation corrections made. No change in coverage.

  • Other (Annual Review)
01/01/2018 R8

01/01/2018: CPT/HCPCS code updates: description change to Group 1 codes: C9600, C9601, C9602, C9603, C9604, C9605, C9607, and C9608.

  • Revisions Due To CPT/HCPCS Code Changes
10/01/2017 R7

 10/01/2017 ICD-10 Code update: To Group 1 added the following diagnosis codes: I21.9, I21.A1 and I21.A9. At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

 

  • Revisions Due To ICD-10-CM Code Changes
03/01/2017 R6 03/01/2017 Annual review done 02/02/2017. Formatting changes made. No change in coverage.
  • Other (Annual Review)
01/01/2017 R5 01/01/2017 Annual code updates: description change to Group 1 codes: 92978 and 92979.
  • Revisions Due To CPT/HCPCS Code Changes
10/01/2016 R4 10/01/2016 Per ICD-10 code updates: In Group 1: description change for codes T82.817A, T82.827A, T82.837A, T82.847A, T82.857A, and T82.867A, effective 10/01/2016.

  • Revisions Due To ICD-10-CM Code Changes
03/01/2016 R3 03/01/2016: Annual review done 02/02/2016; updated Sources of Information and corrected typos.
  • Other (Maintenance-annual review)
12/01/2015 R2 12/01/2015: Under Limitations section removed #4 per Reconsideration Request. Removed CAC information per CMS guidance. Removed L34530 under related local coverage documents as it was retired.
Added italicized font statement and removed unnecessary sources under CMS section.

  • Reconsideration Request
10/01/2015 R1 03/01/2015 Annual review completed 02/02/2015. The following clarifications are effective 04/15/2015 following a 45 notice. Added the Overview section and information on diagnostic cardiac catheterization and PCI to the Indications section. Under the Limitations section, moved all the billing and coding information to the newly created Billing and Coding Guidelines. Clarified documentation requirements and utilization guidelines. Updated the sources of information. Reformatted and corrected typos.

  • Typographical Error
  • Other
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Associated Documents

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Related National Coverage Documents
NCDs
20.7 - Percutaneous Transluminal Angioplasty (PTA)
Public Versions
Updated On Effective Dates Status
12/20/2023 12/28/2023 - N/A Currently in Effect You are here
12/20/2021 12/30/2021 - 12/27/2023 Superseded View
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