TCAR Reimbursement

The latest resources and information concerning coding, payment and coverage of TransCarotid Artery Revascularization (TCAR).

Understanding TCAR Reimbursement

Silk Road Medical is pleased to provide the latest resources and information concerning coding, payment and coverage of TransCarotid Artery Revascularization (TCAR). Please use the tabs above to navigate through the information and resources.

The information provided herein is for informational purposes only and is intended to explain coverage, coding, and payment policies potentially applicable to TCAR using Silk Road Medical’s ENROUTE Transcarotid Neuroprotection (NPS) and Stent System.

TCAR may be described by the same Current Procedural Terminology (CPT®)1 codes and International Classification of Diseases, codes (10th revision, clinical modification) (ICD-10-CM) as Carotid Artery Stenting (CAS). Reimbursement policies and rates applicable to TCAR may be similar to those applicable to CAS.

The ENROUTE Transcarotid NPS and the ENROUTE Transcarotid Stent have been cleared and approved by the U.S. Food and Drug Administration (FDA) for use in the treatment of certain medical conditions. These conditions can be identified by specified ICD-102 diagnosis and procedure codes. The ICD-10 Clinical Modification (ICD-10-CM) codes crosswalk to Medicare Severity Diagnosis Related Groups (MS‐DRG) for the purposes of hospital inpatient reimbursement. Medicare and most other insurers typically make payment for services based on fee schedules tied to CPT codes or MS-DRGs.

 

TCAR Reimbursement Questions:

Please contact your Silk Road Medical representative or call 1-855.410.TCAR (8227) – Option 5

 

1 CPT copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
2 10th revision of the International Statistical Classification of Diseases and Related Health Problems

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.  Please refer to package inserts for indications, contraindications, warnings, precautions, and instructions for use.

Silk Road Medical provides this content for informational purposes only. The information contained herein is gathered from various publicly available sources and is subject to change without notice. Silk Road Medical cannot guarantee (either implicitly or explicitly) success in obtaining coverage or payment. Reimbursement for medical products and services is affected by numerous factors. It is always the provider’s responsibility to determine and submit appropriate codes, charges, and modifiers for services that are rendered. Actual codes and/or modifiers used are at the sole discretion of the treating physician and/or facility. Providers should contact their third-party payers for specific information on their coding, coverage, and payment policies. This guide is in no way intended to promote the off‐label use of any medical device. Information last reviewed October 23, 2020.

 

TCAR Physician Coding and Payment Summary

Physicians may report TCAR procedures using CPT® codes 37215 and 76937-26:

CPT 37215: Transcatheter placement of intravascular stent(s), cervical carotid artery, open or percutaneous, including angioplasty, when performed, and radiological supervision and interpretation; with distal embolic protection

2020
Relative Value Unit (RVU)3 29.04
National Payment4 $1,048
Global period 90 days
Bilateral procedure (modifier 50) Yes
Multiple procedure (modifier 51) Yes
Co-Surgeon (modifier 62) No
Team Surgery No
Assistant surgeon (modifiers 80 – 82) Yes (supporting documentation required)

 

CPT 76937-26: Ultrasound guidance for vascular access requiring ultrasound evaluation of potential access sites, documentation of selected vessel patency, concurrent realtime ultrasound visualization of vascular needle entry, with permanent recording and reporting

2020
Relative Value Unit (RVU)3 0.41
National Payment4 $14.80
Global period 90 days

 

ICD-10-CM diagnosis codes that may support utilization of the TCAR procedure include:
I65.(21,22,23,29) Occlusion and stenosis of (right, left, bilateral, unspecified) carotid artery, not resulting in cerebral infarction
I65.(8,9) Occlusion and stenosis of (other, unspecified) precerebral artery(ies)
I63.(131,132,139) Cerebral infarction due to embolism of (right, left, unspecified) carotid artery
I63.(031,032,039) Cerebral infarction due to thrombus of (right, left, unspecified) carotid artery
I63.(231,232,239) Cerebral infarction due to unspecified occlusion or stenosis of (right, left, unspecified) carotid arteries)
Z00.6 Examination for participant or control in clinical research program

TCAR Surveillance Project National Clinical Trial (NCT): NCT02850588.

Notes:
  • For billing instructions related to clinical studies, e.g. the TCAR Surveillance Project or ROADSTER 2, see TCAR Coverage
  • Some payors require that ICD-10-CM diagnosis codes accompany reported CPT codes for proper claims processing.
  • CPT 37215 describes “distal embolic protection.” This refers to protection of the brain distal to the stent placement. CMS guidance confirms that proximally placed retrograde flow embolic protection systems qualify as distal embolic protection.
  • CPT 37215 includes: Moderate (conscious) sedation (99143-99145), All ipsilateral carotid imaging including completion angiography, Ipsilateral selective carotid catheterization, Placement of embolic protection device, Pre- and post-stenting balloon angioplasty, Completion angiogram. Such services should not be separately reported.5
  • Coverage and payment for CPT code 37215 is:
    • Only available from Medicare in the Inpatient setting;
    • Subject to the terms of the National Coverage Determination Manual Section 20.7; and
    • Only available in facilities certified to have met CMS’s minimum facility standards for performing carotid artery stenting, which include local credentialing requirements. A list of certified facilities is viewable here and more information on the certification process is here.
  • CPT 37216 (Transcatheter placement of intravascular stent(s), cervical carotid artery, open or percutaneous, including angioplasty, when performed, and radiological supervision and interpretation; without distal embolic protection) is not covered by Medicare. This code does not appropriately describe the use of the ENROUTE Transcarotid NPS which is required for both transcarotid access and embolic protection.
  • CPT codes 37217 and 37218 describe carotid stenting in the intrathoracic common carotid and innominate arteries. CPT codes 37217 and 37218, therefore, do not appropriately describe TCAR procedures targeting lesions at the cervical level (at or near the carotid bifurcation).
  • CPT 36625 may be used to describe an additional surgical exposure: Arterial catheterization or cannulation for sampling, monitoring or transfusion (separate procedure); cutdown. According to Medicare’s Correct Coding Policy Edits, when CPT code 36625 is reported with 37215, modifier -59 must also be reported. For the TCAR procedure (37215), modifier 59 would be appropriate with CPT 36625 only if the additional cutdown is performed in a different session or surgery, on a different site, or with a separate incision. If the cutdown is performed on the same artery as the TCAR incision, it would not be reported with modifier 59.
Further information:

Medicare and most payers typically identify services rendered by physicians and other healthcare practitioners according to reported CPT codes.  Payment for services, when appropriate, is generally made according to established fee schedules.  In some instances, reported CPT codes must be supported by reporting an appropriate ICD-10-CM diagnosis code.

Current Procedural Terminology (CPT)
CPT codes are published by the American Medical Association and are used to report medical services and procedures performed by or under the direction of physicians.  Physician payment for procedures may vary according to site of service.  A hospital outpatient department, inpatient department, or ambulatory surgical center (ASC) are considered to be facility settings and services rendered in those settings are payable under the Medicare Physician Fee Schedule at the facility rate.  Physician services provided in the physician office are payable under the Medicare Physician Fee Schedule at the non-facility rate.

Relative value units (RVUs)
RVUs are a measure of relative value used to identify the relative resource intensity of physician services. The Omnibus Budget Reconciliation Act of 1989 required the implementation of a Medicare fee schedule with a listing of distinct physician services. The services are classified using the Current Procedural Terminology, which is owned and maintained by the American Medical Association. Each service in the fee schedule is scored under the resource-based relative value scale (RBRVS) and assigned RVUs which ultimately determine payment for the service.

CPT Modifiers:
According to the CPT, “A modifier provides the means to report or indicate that a service or procedure that has been performed has been altered by some specific circumstance but not changed in its definition or code. Modifiers enable health care professionals to effectively respond to payment policy requirements established by other entities.” A complete listing of modifiers is in Appendix A of the CPT coding book. Not all modifiers can be reported with all CPT codes or with other modifiers. Modifiers may be used to indicate to the recipient of a report that:

  • A service or procedure had both a professional and technical component
  • A service or procedure was performed by more than one physician or other health care professional and/or in more than one location
  • A service of procedure was increased or reduced
  • Only part of a service was performed
  • An adjunctive service was performed
  • A bilateral service was performed
  • A service or procedure was provided more than once
  • Procedure was performed in conjunction with a clinical study

The -62 (co-surgeon) modifier may not be appended to CPT code 37215 (Transcatheter placement of intravascular stent(s), cervical carotid artery, open or percutaneous, including angioplasty, when performed, and radiological supervision and interpretation; with distal embolic protection).

Modifiers ensure that provider services are properly reimbursed. For example, the -80 (assistant surgeon) modifier increases the payment for the CPT code by approximately 16% to account for the additional resources of the assistant surgeon.

  • 80 — Assistant Surgeon: Surgical assistant services may be identified by adding modifier 80 to the usual procedure number(s).
  • 81 — Minimum Assistant Surgeon: Minimum surgical assistant services are identified by adding modifier 81 to the usual procedure number.
  • 82 — Assistant Surgeon (when qualified resident surgeon not available): The unavailability of a qualified resident surgeon is a prerequisite for use of modifier 82 appended to the usual procedure code number(s).

The -50 (bilateral procedure) modifier increases the payment for the CPT code amount by 50% to account for the additional resources required to furnish a bilateral service.

ICD‐10‐CM:
The International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10) is a coding of diseases, signs and symptoms, abnormal findings, complaints, social circumstances and external causes of injury or diseases, as classified by the World Health Organization (WHO). The code set allows more than 69,800 different codes and permits the tracking of many new diagnoses.

For example, when CPT code 37215 is reported to a payer, an appropriate ICD-10-CM diagnosis code may be required for proper claims processing and payment. A given CPT code may be supported by many different ICD-10-CM diagnoses. Providers should refer to Local and National Coverage Determinations (LCDs and NCDs) from CMS and Local Medicare Carriers as well as coverage policies from private insurance payers in order to determine which ICD-10-CM diagnosis codes support which CPT codes.

 

 

3 The 2020 physician relative value units (RVUs) are from the 2020 RVU file available on the CMS website here.

4 The national average 2020 Medicare rates to physicians shown are based on the 2020 conversion factor of $36.09 and do not reflect payment cuts due to sequestration. Medicare payment for a given procedure in a given locality in 2020 should be available on the Medicare Physician Fee Schedule Look-up file accessible through the CMS website at http://www.cms.gov/apps/physician-fee-schedule/overview.aspx. Any payment rates listed may be subject to change without notice. Actual payment to a physician will vary based on geographic location and may also differ based on policies and fee schedules outlined as terms in your health plan and/or payer contracts.

5 American Medical Association (AMA), 2020 Current Procedural Terminology (CPT), Professional Edition.

Silk Road Medical provides this content for informational purposes only. The information contained herein is gathered from various publicly available sources and is subject to change without notice. Silk Road Medical cannot guarantee (either implicitly or explicitly) success in obtaining coverage or payment. Reimbursement for medical products and services is affected by numerous factors. It is always the provider’s responsibility to determine and submit appropriate codes, charges, and modifiers for services that are rendered. Actual codes and/or modifiers used are at the sole discretion of the treating physician and/or facility. Providers should contact their third-party payers for specific information on their coding, coverage, and payment policies. This guide is in no way intended to promote the off‐label use of any medical device. Information last reviewed November 15, 2019

TCAR Hospital Coding and Payment

Hospitals are reimbursed for TCAR procedures based on MS-DRG classifications derived from ICD-10-CM diagnosis and ICD-10-PCS codes that describe the patient’s diagnoses and procedure(s) performed during the hospital stay.

 

Appropriate ICD-10-CM diagnosis codes for the TCAR procedure include:

 

I65.(21,22,23,29) Occlusion and stenosis of (right, left, bilateral, unspecified) carotid artery, not resulting in cerebral infarction
I65.(8,9) Occlusion and stenosis of (other, unspecified) precerebral artery(ies)
I63.(131,132,139) Cerebral infarction due to embolism of (right, left, unspecified) carotid artery
I63.(031,032,039) Cerebral infarction due to thrombus of (right, left, unspecified) carotid artery
I63.(231,232,239) Cerebral infarction due to unspecified occlusion or stenosis of (right, left, unspecified) carotid arteries)

 

CMS APPROVED CAROTID ARTERY STUDY:
SVS VQI TransCarotid Revasculariization Surveilance Project (VQI-TSP) NATIONAL CLINICAL TRIAL # 02850588

 

 

 

 
C-Codes for the TCAR Procedure

C-Codes are generally used only for the outpatient setting.  TCAR and transfemoral carotid artery stenting procedures only receive CMS coverage when performed on an in-patient basis.  The following C-codes are therefore used primarily for internal tracking purposes only.

  • C1884: Embolization Protection System
    ENROUTE® Transcarotid Neuroprotection System
  • C1876: Stent Non-Coated/Non-Covered with Delivery System
    ENROUTE® Transcarotid Stent System
  • C1894: Introducer/Sheath, Non-Laser
    Silk Road Medical Micro-Introducer Kit
  • C1769: Guide wire
    ENROUTE® .014” Guidewire

 

Notes:
  • For billing instructions related to clinical studies, e.g. the TCAR Surveillance Project or ROADSTER 2, see TCAR Coverage
  • ICD-10 defines “Percutaneous” as entry, by puncture or major incision, of instrumentation through the skin or mucous membrane and/or any other body layers necessary to reach the site of the procedure. TCAR is considered “percutaneous” by this definition.

Further information:

Medicare reimburses hospital inpatient procedures according to Medicare Severity Diagnosis Related Group (MS‐DRG) that are determined by reported ICD-10-CM and/or ICD-10-PCS codes.

 

Medicare Severity Diagnosis Related Group (MS‐DRG)

The MS‐DRG is a system of classifying patients based on their diagnoses and the procedures performed during their hospital stay. MS‐DRGs closely calibrate payment for groups of services based on the severity of a patient’s illness. One single MS‐DRG payment is intended to cover all hospital costs associated with treating an individual during his or her hospital stay, with the exception of “professional” (e.g., physician) charges associated with performing medical procedures.  In some instances, commercial payers also use the MS‐DRG system or other payer‐specific system to pay hospitals for providing inpatient services.

The MS-DRGs are assigned using the principal ICD-10-CM diagnosis and additional or secondary ICD-10-CM diagnoses, the principal ICD-10-PCS procedure and additional ICD-10-PCS procedures, sex, and discharge status.

Clearly documenting procedures has become increasingly more important for both physicians and hospitals, especially with the much greater specificity of ICD-10 when compared to ICD-9.  A thorough description of a patient’s primary and all secondary diagnoses in that patient’s history and physical (H&P) along with detailed procedure dictation is the only way to ensure that a hospital will receive the appropriate MS-DRG assignment for that patient discharge as well as to ensure that the physician is reimbursed properly.  Documentation is also critical for any post-procedure audit by a payer such as CMS with the Recovery Audit Contractors (RACs).  A sample dictation for a TCAR case can be found here.

 

Complications or Comorbidities

In the MS-DRG system, many DRGs are split into one, two or three MS-DRGs based on whether any one of the secondary diagnoses has been categorized as a major complication or comorbidity (MCC), a complication or comorbidity (CC), or no complication or comorbidity (no CC).

An example of an MS-DRG with a three way split is “Carotid Artery Stent Procedure”:

  • 034, Carotid Artery Stent Procedure with major complication/comorbidity (MCC)
  • 035, Carotid Artery Stent Procedure with complication/comorbidity (CC)
  • 036, Carotid Artery Stent Procedure without CC or MCC

Under MS-DRGs, CMS identified those diagnoses whose presence as a secondary diagnosis leads to substantially increased hospital resource use. They then categorized this list into two different levels of severity.

 

MCCs reflect the highest level of severity. Examples:

  • N18.6, End Stage Renal Disease
  • I63.50, Cerebral artery occlusion, unspecified with cerebral infarction.

 

CCs represent the next level of severity. Examples:

  • J96.10, Chronic Respiratory Failure
  • N17.9 Acute Kidney Failure unspecified

 

A full list of MCCs and CCs can be found in Final Rule Tables 6I and 6J on CMS.gov.

Some MCCs and CCs are excluded because they are too closely related to the principal diagnoses. This is called the CC Exclusion List and identifies conditions that will not be considered a CC or MCC for a given principal diagnosis. For example, other restrictive cardiomyopathy (I42.5) is not a CC for congestive heart failure unspecified (I50.9).

 

ICD‐10‐CM (Clinical Modification)

The International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10) is a coding of diseases, signs and symptoms, abnormal findings, complaints, social circumstances and external causes of injury or diseases, as classified by the World Health Organization (WHO). The code set allows more than 14,400 different codes and permits the tracking of many new diagnoses.

ICD-10 is an updated version of the ICD-9 code sets. Several countries have taken the ICD-10 code set and modified it for use in their medical systems. The United States, through the National Center for Health Statistics, has developed the ICD-10-CM (or Clinical Modification) version of the code set for use in the US.

 

ICD-10-PCS (Procedure Code Set)

For detailed information, please refer to CMS’s Development of the ICD-10 Procedure Coding System.

The development of ICD-10-PCS was funded by the U.S. Centers for Medicare and Medicaid Services (CMS). ICD-10-PCS has a multiaxial seven character alphanumeric code structure that provides a unique code for all substantially different procedures, and allows new procedures to be easily incorporated as new codes.

ICD-10-PCS has a seven character alphanumeric code structure. Each character contains up to 34 possible values. Each value represents a specific option for the general character definition (e.g., stomach is one of the values for the body part character). The ten digits 0-9 and the 24 letters A-H, J-N and P-Z may be used in each character. The letters O and I are not used in order to avoid confusion with the digits 0 and 1. Procedures are divided into sections that identify the general type of procedure (e.g., medical and surgical, obstetrics, imaging).

National Unadjusted Payment Amounts for MS-DRGs 034, 035, and 036 “Carotid Artery Stent Procedure” (inclusive of TCAR) are: 6

  FY 2021
034 with major complication or comorbidity (MCC) $25,546
035 with complication or comorbidity (CC) $15,022
036 without CC/MCC $11,898

 

 

6 The national average FY2021 Medicare rates for the hospital inpatient setting are calculated from the Inpatient Prospective Payment System (IPPS), effective October 1, 2020. Any payment rates listed are Medicare national averages that may be subject to change without notice. Actual payment to a hospital will vary based on geographic location and may also differ based on policies and fee schedules outlined as terms in your health plan and/or payer contracts.

Silk Road Medical provides this content for informational purposes only. The information contained herein is gathered from various sources and is subject to change without notice. Silk Road Medical cannot guarantee success in obtaining coverage or payment. Reimbursement for medical products and services is affected by numerous factors. It is always the provider’s responsibility to determine and submit appropriate codes, charges, and modifiers for services that are rendered. Actual codes and/or modifiers used are at the sole discretion of the treating physician and/or facility. Providers should contact their third-party payers for specific information on their coding, coverage, and payment policies. This guide is in no way intended to promote the off‐label use of any medical device. Information last reviewed October 23, 2020.

Carotid Artery Stenting Coverage Policies

Commercial and Other Third Party Payor Coverage Policies
Coverage varies regionally and providers should verify insurance coverage before performing procedures. Please contact individual insurance carriers to determine eligibility.

 

Medicare (CMS) Coverage

Medicare’s National Coverage Decision (NCD Manual Section 20.7) covers inpatient carotid artery stenting procedures including TCAR in select patient populations as follows:

Patients who are at high risk for CEA and have

  1. symptomatic carotid artery stenosis ≥70%, or
  2. symptomatic carotid artery stenosis 50-70%*, or
  3. asymptomatic carotid artery stenosis ≥80%*.

*Patients in categories 2 and 3 above are only covered if procedures are performed:

 
CMS Definition of Symptomatic

Symptoms of carotid artery stenosis include carotid transient ischemic attack (distinct focal neurological dysfunction persisting less than 24 hours), focal cerebral ischemia producing a nondisabling stroke (modified Rankin scale < 3 with symptoms for 24 hours or more), and transient monocular blindness (amaurosis fugax). Patients who have had a disabling stroke (modified Rankin scale ≥ 3) shall be excluded from coverage.

 
CMS Definition of Stenosis Measurement

The degree of carotid artery stenosis shall be measured by duplex Doppler ultrasound or carotid artery angiography and recorded in the patient’s medical records. If the stenosis is measured by ultrasound prior to the procedure, then the degree of stenosis must be confirmed by angiography at the start of the procedure. If the stenosis is determined to be <70% by angiography, then CAS should not proceed.

 
CMS Definitions of High Surgical Risk

Patients at high risk for CEA are defined as having significant comorbidities and/or anatomic risk factors (i.e., recurrent stenosis and/or previous radical neck dissection), and would be poor candidates for CEA.  The determination that a patient is at high risk for CEA and the patient’s symptoms of carotid artery stenosis shall be available in the patient medical records prior to performing any procedure.

The definitions used to determine patients at high risk for CEA include those criteria used in the prior carotid artery stenting trials and studies. An amalgamation of the “High Risk for CEA” inclusion criteria of those studies is as follows7; patients must have one or more criteria:

 

Comorbid conditions:
1. Age ≥75
2. Congestive Heart Failure
3. Left Ventricular Ejection Fraction ≤35%
4. Two or more diseased coronary arteries with ≥70% stenosis
5. Unstable angina
6. Myocardial infarction within 6 weeks
7. Abnormal stress test
8. Need for open heart surgery
9. Need for major surgery (including vascular)
10. Uncontrolled diabetes
11. Severe pulmonary disease
12. History of liver failure with elevated prothrombin time
Anatomic conditions
1. Prior head/neck surgery or irradiation
2. Spinal immobility
3. At risk for wound infection
4. Restenosis post CEA
5. Tracheostomy or tracheostoma
6. Surgically inaccessible lesion
7. Laryngeal palsy; Laryngectomy; Permanent contralateral cranial nerve injury
8. Contralateral occlusion
9. Severe tandem lesions
10. Bilateral stenosis requiring treatment
11. Dissection

 

Notes:
  • TCAR is only reimbursed by Medicare when performed in the Inpatient setting.
  • Carotid artery stenting without embolic protection is not covered by Medicare. The ENROUTE Transcarotid NPS used in TCAR procedures provides flow reversal embolic protection, and therefore is defined as carotid artery stenting with embolic protection.
  • Medicare will only cover TCAR in facilities that have met CMS’s minimum facility standards for performing carotid artery stenting. A list of certified facilities is viewable here and more information on the certification process is here.
  • Claims billed under a Category B IDE (identified by a six-digit IDE number preceded by a “G,” e.g., G123456); or a billed under an FDA-approved post-approval study (identified by a six digit PMA number preceded by a “P,” e.g., P123456) are not subject to the approved facility list.
  • Coverage is limited to procedures performed using FDA-approved carotid artery stents and FDA-approved or cleared embolic protection devices.
TCAR Coverage⁸

TCAR Surveillance Project https://clinicaltrials.gov/ct2/show/study/NCT02850588

Effective September 1, 2016, hospitals participating in the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) receive CMS coverage for Transcarotid Artery Revascularization (TCAR) procedures entered into the VQI Carotid Artery Stenting module.  According to the National Coverage Determination (NCD) 20.7 for Percutaneous Transluminal Angioplasty, the TCAR Surveillance Project is an FDA-approved post approval carotid stenting study.  CMS will reimburse hospitals and physicians for symptomatic and asymptomatic patients at high risk for traditional carotid artery surgery who participate in the TCAR Surveillance Project.

The Patient Safety Organization (PSO) for the SVS has made public the CMS letter detailing the approval of the TCAR Surveillance Project. The Project Coverage Letter can now be found on the VQI website with the following link: http://www.vascularqualityinitiative.org/vqi-resource-library/tcar-surveillance-project/

Under NCD 20.7, the TCAR Surveillance Project does not require the study sites to get approval from the Medicare Administrative Contractors. For billing purposes, facilities and providers will submit claims for the TCAR Surveillance Project using National Clinical Trial (NCT) identifier NCT02850588.

 

Post-Approval Study # / PMA #: NCT02850588
Study Name: The TCAR Surveillance Project
Study Procedure: Transcarotid Artery Revascularization (TCAR)
Direct implantation of a stent into the carotid artery via surgical incision in the neck combined with blood flow reversal in the carotid artery during stent placement.
Study Products: ENROUTE® Transcarotid Neuroprotection System
ENROUTE® Transcarotid Stent System
Any FDA-cleared proximal embolic protection device and FDA-approved carotid artery stent system indicated for the transcarotid approach

 

CREST-2 Registry https://clinicaltrials.gov/ct2/show/NCT02240862

TCAR and the ENROUTE Neuroprotection and Stent System are included in the CREST-2 Registry. Providers can bill Medicare for TCAR patients enrolled in this registry using NCT02240862.

CREST-2 Randomized Trial https://clinicaltrials.gov/ct2/show/NCT02089217

TCAR and the ENROUTE Neuroprotection and Stent System are excluded from the CREST-2 randomized trial.

 

 

7 National Coverage Determination (NCD) for PERCUTANEOUS TRANSLUMINAL Angioplasty (PTA) (20.7)
Stenting and Angioplasty With Protection in Patients at High Risk for Endarterectomy (SAPPHIRE)
ACCULINK for Revascularization of Carotids in High-Risk patients (ARCHER)
Protected Carotid Artery Stenting in Subjects at High Risk for Carotid Endarterectomy (CEA) (PROTECT)
A Carotid Stenting Trial for High-Risk Surgical Patients (BEACH)
Carotid Revascularization With ev3 Arterial Technology Evolution (CREATE)
Carotid Artery Revascularization Using the Boston Scientific EPI Filter Wire EZ™ and the EndoTex™ NexStent™ (CABERNET)
FiberNet® Emboli Protection Device in Carotid Artery Stenting (EPIC)
Proximal Protection With The Mo.Ma Device During Carotid Stenting (ARMOUR)
GORE Embolic Protection With Reverse Flow (EMPiRE)
Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER)
Stroke. 2010;41:e102-e109. (The MAVERIC I and II trials were completed before July 2005 and therefore they not registered in a public clinical trials database.)

8 See CMS, Medicare Claims Processing Manual Ch. 32 §§ 68.2, 69.6, 160.2 available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c32.pdf

Silk Road Medical provides this content for informational purposes only. The information contained herein is gathered from various publicly available sources and is subject to change without notice. Silk Road Medical cannot guarantee (either implicitly or explicitly) success in obtaining coverage or payment. Reimbursement for medical products and services is affected by numerous factors. It is always the provider’s responsibility to determine and submit appropriate codes, charges, and modifiers for services that are rendered. Actual codes and/or modifiers used are at the sole discretion of the treating physician and/or facility. Providers should contact their third-party payers for specific information on their coding, coverage, and payment policies. This guide is in no way intended to promote the off‐label use of any medical device. Information last reviewed January 15, 2019.

Documentation

Clearly documenting procedures has become increasingly more important for both physicians and hospitals.  A thorough description of a patient’s primary and all secondary diagnoses in that patient’s history and physical (H&P) along with detailed procedure dictation is the only way to ensure that a patient’s discharge is assigned to the appropriate MS-DRG and to ensure appropriate reimbursement.  Documentation is also critical for any post-procedure audit by a payer such as CMS with the Recovery Audit Contractors (RACs).

 
Request for Prior Authorization

While both carotid artery stenting and the TCAR procedure are covered under Medicare’s NCD Manual Section 20.7 if the appropriate coverage criteria are met, some non-Medicare commercial payers may have additional coverage requirements. Such payers may also require prior authorization before carotid artery revascularization can be performed. Sample letters requesting prior authorization for the TCAR procedure can be found here:

 
Denials from Payers

Some non-Medicare commercial payers will deny coverage for either carotid artery stenting or the TCAR procedure. A request for reconsideration should be sent. Such requests should always include a detailed explanation of the medical necessity for the individual patient and any other supporting material such as information about the TCAR procedure itself.

 
Links to Reimbursement Related Resources

 

CMS Resources
CMS.gov
CMS Carotid Artery Stenting Facility Certification Process
CMS Carotid Artery Stenting Certified Facilities
CMS Approved Carotid Artery Stenting Studies
Percutaneous Transluminal Angioplasty (including Carotid Artery Stenting) National Coverage Determination Manual Section 20.7
National Correct Coding Initiative
Physician Fee Schedule
Physician Fee Schedule Look-up

Silk Road Medical Resources
FDA Approval Letter: ENROUTE Transcarotid Neuroprotection System
FDA Approval Letter: ENROUTE Transcarotid Stent System

General Reimbursement Resources
International Classification of Diseases (ICD)
American Medical Association (AMA) Current Procedural Terminology (CPT)