CMS Pub. 100-04, ch. 32, § 160.2.1

A. Background

As the post-approval studies began to end, CMS received requests to extend coverage for the post-approval studies. CMS has reviewed the extension requests and has determined that patients participating

in post-approval extension studies are also included in the currently covered population of patients

participating in FDA-approved post-approval studies.

B. Policy

To grant approval for post-approval studies, the FDA reviews each study protocol. Once approval is

granted, the FDA issues a formal approval letter to the study sponsor.

Extensions of post-approval studies are not subject to approval by the FDA because they surpass the post-approval study requirements identified in the conditions of approval for post-approval studies. Since the

FDA cannot approve these extension studies, individual Post-Market Approval (PMA) numbers cannot be

issued to separately identify each study. Currently, in order to receive reimbursement for procedures

performed as part of a carotid artery stenting post-approval study, providers must include the FDA-issued

PMA number on each claim to indicate participation in a specific study.

CMS has determined that all extension studies must be reviewed by the FDA. The FDA will issue an

acknowledgement letter stating that the extension study is scientifically valid and will generate clinically

relevant post-market data. Upon receipt of this letter and review of the extension study protocol, CMS will

issue a letter to the study sponsor indicating that the study under review will be covered by Medicare. Since

an individual PMA number cannot be assigned by the FDA to each extension study, these studies will use

the PMA number assigned to the original FDA-approved post-approval study (i.e., CAPTURE 2 shall use

the PMA number assigned to CAPTURE 1).

C. Billing

In order to receive Medicare coverage for patients participating in post-approval extension studies,

providers shall submit both the FDA acknowledgement letter and the CMS letter providing coverage for

the extension study to their contractor. Additionally, providers shall submit any other materials contractors

would require for FDA-approved post- approval studies.

In response, contractors will issue a letter assigning an effective date for each facility’s participation in the

extension study. Providers may bill for procedures performed in the extension study for dates of service on

and after the assigned effective date. Providers billing A/B MACs (A) must bill using the most current

ICD-10-CM is applicable, Indications for PTA of the Carotid Artery Concurrent with Stenting (must bill

one of these primary codes to meet coverage under 20.7B2, 20.7B3, 20.7B4)

I63.031 Cerebral infarction due to thrombosis of right carotid artery

I63.032 Cerebral infarction due to thrombosis of left carotid artery

I63.033 Cerebral infarction due to thrombosis of bilateral carotid arteries

I63.131 Cerebral infarction due to embolism of right carotid artery

I63.132 Cerebral infarction due to embolism of left carotid artery

I63.133 Cerebral infarction due to embolism of bilateral carotid arteries

I63.231 Cerebral infarction due to unspecified occlusion or stenosis of

right carotid arteries

I63.232 Cerebral infarction due to unspecified occlusion or stenosis of

left carotid arteries

I63.233 Cerebral infarction due to unspecified occlusion or stenosis of

bilateral carotid arteries

I65.21 Occlusion and stenosis of right carotid artery

I65.22 Occlusion and stenosis of left carotid artery

I65.23 Occlusion and stenosis of bilateral carotid arteries

ICD-10-PCS codes may be used.

037G34Z Dilation of Intracranial Artery with Drug-eluting Intraluminal Device, Percutaneous Approach

037G35Z Dilation of Intracranial Artery with Two Drug-eluting Intraluminal Devices, Percutaneous Appro

037G36Z Dilation of Intracranial Artery with Three Drug-eluting Intraluminal Devices, Percutaneous Appr

037G37Z

Dilation of Intracranial Artery with Four or More Drug-eluting Intraluminal Devices, Percutaneo

Approach

037G3DZ Dilation of Intracranial Artery with Intraluminal Device, Percutaneous Approach

037G3EZ Dilation of Intracranial Artery with Two Intraluminal Devices, Percutaneous Approach

037G3FZ Dilation of Intracranial Artery with Three Intraluminal Devices, Percutaneous Approach

037G3GZ Dilation of Intracranial Artery with Four or More Intraluminal Devices, Percutaneous Approach

037G44Z

Dilation of Intracranial Artery with Drug-eluting Intraluminal Device, Percutaneous Endoscopic

Approach

037G45Z

Dilation of Intracranial Artery with Two Drug-eluting Intraluminal Devices, Percutaneous Endos

Approach

037G46Z

Dilation of Intracranial Artery with Three Drug-eluting Intraluminal Devices, Percutaneous

Endoscopic Approach

037G47Z

Dilation of Intracranial Artery with Four or More Drug-eluting Intraluminal Devices, Percutaneo

Endoscopic Approach

037G4DZ Dilation of Intracranial Artery with Intraluminal Device, Percutaneous Endoscopic Approach

037G4EZ Dilation of Intracranial Artery with Two Intraluminal Devices, Percutaneous Endoscopic Approa

037G4FZ Dilation of Intracranial Artery with Three Intraluminal Devices, Percutaneous Endoscopic Appro

037G4GZ

Dilation of Intracranial Artery with Four or More Intraluminal Devices, Percutaneous Endoscopic

Approach

037H34Z

Dilation of Right Common Carotid Artery with Drug-eluting Intraluminal Device, Percutaneous

Approach

037H35Z

Dilation of Right Common Carotid Artery with Two Drug-eluting Intraluminal Devices, Percutan

Approach

037H36Z

Dilation of Right Common Carotid Artery with Three Drug-eluting Intraluminal Devices,

Percutaneous Approach

037H37Z

Dilation of Right Common Carotid Artery with Four or More Drug-eluting Intraluminal Devices,

Percutaneous Approach

037H3DZ Dilation of Right Common Carotid Artery with Intraluminal Device, Percutaneous Approach

037H3EZ Dilation of Right Common Carotid Artery with Two Intraluminal Devices, Percutaneous Approa

037H3FZ Dilation of Right Common Carotid Artery with Three Intraluminal Devices, Percutaneous Appro

037H3GZ

Dilation of Right Common Carotid Artery with Four or More Intraluminal Devices, Percutaneous

Approach

037H44Z

Dilation of Right Common Carotid Artery with Drug-eluting Intraluminal Device, Percutaneous

Endoscopic Approach

037H45Z

Dilation of Right Common Carotid Artery with Two Drug-eluting Intraluminal Devices, Percutan

Endoscopic Approach

037H46Z

Dilation of Right Common Carotid Artery with Three Drug-eluting Intraluminal Devices,

Percutaneous Endoscopic Approach

037H47Z

Dilation of Right Common Carotid Artery with Four or More Drug-eluting Intraluminal Devices,

Percutaneous Endoscopic Approach

037H4DZ

Dilation of Right Common Carotid Artery with Intraluminal Device, Percutaneous Endoscopic

Approach

037H4EZ

Dilation of Right Common Carotid Artery with Two Intraluminal Devices, Percutaneous Endosc

Approach

037H4FZ

Dilation of Right Common Carotid Artery with Three Intraluminal Devices, Percutaneous Endos

Approach

037H4GZ

Dilation of Right Common Carotid Artery with Four or More Intraluminal Devices, Percutaneous

Endoscopic Approach

037J34Z

Dilation of Left Common Carotid Artery with Drug-eluting Intraluminal Device, Percutaneous

Approach

037J35Z

Dilation of Left Common Carotid Artery with Two Drug-eluting Intraluminal Devices, Percutane

Approach

037J36Z

Dilation of Left Common Carotid Artery with Three Drug-eluting Intraluminal Devices, Percutan

Approach

037J37Z

Dilation of Left Common Carotid Artery with Four or More Drug-eluting Intraluminal Devices,

Percutaneous Approach

037J3DZ Dilation of Left Common Carotid Artery with Intraluminal Device, Percutaneous Approach

037J3EZ Dilation of Left Common Carotid Artery with Two Intraluminal Devices, Percutaneous Approach

037J3FZ Dilation of Left Common Carotid Artery with Three Intraluminal Devices, Percutaneous Approa

037J3GZ

Dilation of Left Common Carotid Artery with Four or More Intraluminal Devices, Percutaneous

Approach

037J44Z

Dilation of Left Common Carotid Artery with Drug-eluting Intraluminal Device, Percutaneous

Endoscopic Approach

037J45Z

Dilation of Left Common Carotid Artery with Two Drug-eluting Intraluminal Devices, Percutane

Endoscopic Approach

037J46Z

Dilation of Left Common Carotid Artery with Three Drug-eluting Intraluminal Devices, Percutan

Endoscopic Approach

037J47Z

Dilation of Left Common Carotid Artery with Four or More Drug-eluting Intraluminal Devices,

Percutaneous Endoscopic Approach

037J4DZ

Dilation of Left Common Carotid Artery with Intraluminal Device, Percutaneous Endoscopic

Approach

037J4EZ

Dilation of Left Common Carotid Artery with Two Intraluminal Devices, Percutaneous Endoscop

Approach

037J4FZ

Dilation of Left Common Carotid Artery with Three Intraluminal Devices, Percutaneous Endosco

Approach

037J4GZ

Dilation of Left Common Carotid Artery with Four or More Intraluminal Devices, Percutaneous

Endoscopic Approach

037K34Z

Dilation of Right Internal Carotid Artery with Drug-eluting Intraluminal Device, Percutaneous

Approach

037K35Z

Dilation of Right Internal Carotid Artery with Two Drug-eluting Intraluminal Devices, Percutane

Approach

037K36Z

Dilation of Right Internal Carotid Artery with Three Drug-eluting Intraluminal Devices, Percutan

Approach

037K37Z

Dilation of Right Internal Carotid Artery with Four or More Drug-eluting Intraluminal Devices,

Percutaneous Approach

037K3DZ Dilation of Right Internal Carotid Artery with Intraluminal Device, Percutaneous Approach

037K3EZ Dilation of Right Internal Carotid Artery with Two Intraluminal Devices, Percutaneous Approach

037K3FZ Dilation of Right Internal Carotid Artery with Three Intraluminal Devices, Percutaneous Approac

037K3GZ

Dilation of Right Internal Carotid Artery with Four or More Intraluminal Devices, Percutaneous

Approach

037K44Z

Dilation of Right Internal Carotid Artery with Drug-eluting Intraluminal Device, Percutaneous

Endoscopic Approach

037K45Z

Dilation of Right Internal Carotid Artery with Two Drug-eluting Intraluminal Devices, Percutane

Endoscopic Approach

037K46Z

Dilation of Right Internal Carotid Artery with Three Drug-eluting Intraluminal Devices, Percutan

Endoscopic Approach

037K47Z

Dilation of Right Internal Carotid Artery with Four or More Drug-eluting Intraluminal Devices,

Percutaneous Endoscopic Approach

037K4DZ

Dilation of Right Internal Carotid Artery with Intraluminal Device, Percutaneous Endoscopic

Approach

037K4EZ

Dilation of Right Internal Carotid Artery with Two Intraluminal Devices, Percutaneous Endoscop

Approach

037K4FZ

Dilation of Right Internal Carotid Artery with Three Intraluminal Devices, Percutaneous Endosco

Approach

037K4GZ

Dilation of Right Internal Carotid Artery with Four or More Intraluminal Devices, Percutaneous

Endoscopic Approach

037L34Z

Dilation of Left Internal Carotid Artery with Drug-eluting Intraluminal Device, Percutaneous

Approach

037L35Z

Dilation of Left Internal Carotid Artery with Two Drug-eluting Intraluminal Devices, Percutaneo

Approach

037L36Z

Dilation of Left Internal Carotid Artery with Three Drug-eluting Intraluminal Devices, Percutane

Approach

037L37Z

Dilation of Left Internal Carotid Artery with Four or More Drug-eluting Intraluminal Devices,

Percutaneous Approach

037L3DZ Dilation of Left Internal Carotid Artery with Intraluminal Device, Percutaneous Approach

037L3EZ Dilation of Left Internal Carotid Artery with Two Intraluminal Devices, Percutaneous Approach

037L3FZ Dilation of Left Internal Carotid Artery with Three Intraluminal Devices, Percutaneous Approach

037L3GZ

Dilation of Left Internal Carotid Artery with Four or More Intraluminal Devices, Percutaneous

Approach

037L44Z

Dilation of Left Internal Carotid Artery with Drug-eluting Intraluminal Device, Percutaneous

Endoscopic Approach

037L45Z

Dilation of Left Internal Carotid Artery with Two Drug-eluting Intraluminal Devices, Percutaneo

Endoscopic Approach

037L46Z

Dilation of Left Internal Carotid Artery with Three Drug-eluting Intraluminal Devices, Percutane

Endoscopic Approach

037L47Z

Dilation of Left Internal Carotid Artery with Four or More Drug-eluting Intraluminal Devices,

Percutaneous Endoscopic Approach

037L4DZ Dilation of Left Internal Carotid Artery with Intraluminal Device, Percutaneous Endoscopic App

037L4EZ

Dilation of Left Internal Carotid Artery with Two Intraluminal Devices, Percutaneous Endoscopi

Approach

037L4FZ

Dilation of Left Internal Carotid Artery with Three Intraluminal Devices, Percutaneous Endoscop

Approach

037L4GZ

Dilation of Left Internal Carotid Artery with Four or More Intraluminal Devices, Percutaneous

Endoscopic Approach

037M34Z

Dilation of Right External Carotid Artery with Drug-eluting Intraluminal Device, Percutaneous

Approach

037M35Z

Dilation of Right External Carotid Artery with Two Drug-eluting Intraluminal Devices, Percutan

Approach

037M36Z

Dilation of Right External Carotid Artery with Three Drug-eluting Intraluminal Devices,

Percutaneous Approach

037M37Z

Dilation of Right External Carotid Artery with Four or More Drug-eluting Intraluminal Devices,

Percutaneous Approach

037M3DZ Dilation of Right External Carotid Artery with Intraluminal Device, Percutaneous Approach

037M3EZ Dilation of Right External Carotid Artery with Two Intraluminal Devices, Percutaneous Approac

037M3FZ Dilation of Right External Carotid Artery with Three Intraluminal Devices, Percutaneous Approa

037M3GZ

Dilation of Right External Carotid Artery with Four or More Intraluminal Devices, Percutaneous

Approach

037M44Z

Dilation of Right External Carotid Artery with Drug-eluting Intraluminal Device, Percutaneous

Endoscopic Approach

037M45Z

Dilation of Right External Carotid Artery with Two Drug-eluting Intraluminal Devices, Percutan

Endoscopic Approach

037M46Z

Dilation of Right External Carotid Artery with Three Drug-eluting Intraluminal Devices,

Percutaneous Endoscopic Approach

037M47Z

Dilation of Right External Carotid Artery with Four or More Drug-eluting Intraluminal Devices,

Percutaneous Endoscopic Approach

037M4DZ

Dilation of Right External Carotid Artery with Intraluminal Device, Percutaneous Endoscopic

Approach

037M4EZ

Dilation of Right External Carotid Artery with Two Intraluminal Devices, Percutaneous Endosco

Approach

037M4FZ

Dilation of Right External Carotid Artery with Three Intraluminal Devices, Percutaneous Endosc

Approach

037M4GZ

Dilation of Right External Carotid Artery with Four or More Intraluminal Devices, Percutaneous

Endoscopic Approach

037N34Z

Dilation of Left External Carotid Artery with Drug-eluting Intraluminal Device, Percutaneous

Approach

037N35Z

Dilation of Left External Carotid Artery with Two Drug-eluting Intraluminal Devices, Percutaneo

Approach

037N36Z

Dilation of Left External Carotid Artery with Three Drug-eluting Intraluminal Devices, Percutane

Approach

037N37Z

Dilation of Left External Carotid Artery with Four or More Drug-eluting Intraluminal Devices,

Percutaneous Approach

037N3DZ Dilation of Left External Carotid Artery with Intraluminal Device, Percutaneous Approach

037N3EZ Dilation of Left External Carotid Artery with Two Intraluminal Devices, Percutaneous Approach

037N3FZ Dilation of Left External Carotid Artery with Three Intraluminal Devices, Percutaneous Approac

037N3GZ

Dilation of Left External Carotid Artery with Four or More Intraluminal Devices, Percutaneous

Approach

037N44Z

Dilation of Left External Carotid Artery with Drug-eluting Intraluminal Device, Percutaneous

Endoscopic Approach

037N45Z

Dilation of Left External Carotid Artery with Two Drug-eluting Intraluminal Devices, Percutaneo

Endoscopic Approach

037N46Z

Dilation of Left External Carotid Artery with Three Drug-eluting Intraluminal Devices, Percutan

Endoscopic Approach

037N47Z

Dilation of Left External Carotid Artery with Four or More Drug-eluting Intraluminal Devices,

Percutaneous Endoscopic Approach

037N4DZ

Dilation of Left External Carotid Artery with Intraluminal Device, Percutaneous Endoscopic

Approach

037N4EZ

Dilation of Left External Carotid Artery with Two Intraluminal Devices, Percutaneous Endoscop

Approach

037N4FZ

Dilation of Left External Carotid Artery with Three Intraluminal Devices, Percutaneous Endosco

Approach

037N4GZ

Dilation of Left External Carotid Artery with Four or More Intraluminal Devices, Percutaneous

Endoscopic Approach

160.3 – Carotid Artery Stenting (CAS) With Embolic Protection Coverage

(Rev. 12571; Issued: 04-11-24) Effective: 10-11-23; Implementation: 05-13-24)

On October 11, 2023, CMS issued a reconsideration of NCD 20.7. The updated NCD covers PTA of the

carotid artery concurrent with stenting with the placement of an FDA-approved carotid stent with an FDA-approved or cleared embolic protection device, for Medicare beneficiaries with symptomatic carotid artery

stenosis ≥50% and asymptomatic carotid artery stenosis ≥70%. The NCD also sets forth requirements

regarding neurological assessments, imaging, shared decision-making, and retains institutional and physician

standards but removes the requirement that facilities that perform CAS procedures must be approved by CMS.

Additionally, CMS revised section D of NCD 20.7 to allow MACs to make reasonable and necessary

determinations under section 1862(a)(1)(A) for any other beneficiary seeking coverage for PTA of the carotid

artery concurrent with stenting.

A. Billing

Effective for claims with dates of services on or after October 11, 2023, contractors shall cover PTA of the

carotid artery concurrent with stenting with the placement of an FDA-approved carotid stent with an FDA-approved or cleared embolic protection device, for Medicare beneficiaries under the following conditions:

A. Patients with symptomatic carotid artery stenosis ≥50%; and,

B. Patients with asymptomatic carotid artery stenosis ≥70%.

Also effective for claims with dates of service on or after October 11, 2023, beneficiaries no longer have to be

enrolled in a clinical trial for this service. Contractors may also pay for claims for PTA of the carotid artery

concurrent with stenting not otherwise addressed in The National Coverage Determinations Manual, Chapter

1, part 1, section 20.7 at local discretion.

Effective March 17, 2005, through October 10, 2023, Medicare covered PTA of the carotid artery concurrent

with the placement of an FDA-approved carotid stent with embolic protection under specific patient

indications found in Pub. 100-03, Medicare National Coverage Determinations Manual, part 1, section 20.7.

Coverage was limited to procedures performed using FDA-approved CAS systems and FDA-approved or –

cleared (effective December 9, 2009) embolic protection devices (EPDs). If deployment of the EPD was not

technically possible, and not performed, then the procedure was not covered.

In addition to the specific patient indications, CMS determined that CAS with embolic protection was

reasonable and necessary only if performed in facilities that had been determined to be competent in

performing the evaluation, procedure, and follow-up necessary to ensure optimal patient outcomes. CMS

created a list of minimum standards modeled in part on professional society statements on competency. All

facilities were required to at least meet CMS’s standards in order to receive coverage for CAS for high-risk

patients. Facilities were required to recertify every 2 years in order to maintain coverage of CAS procedures.