(Medicare Claims Processing Manual)

160.3  Carotid Artery Stenting (CAS) With Embolic Protection Coverage  (Rev. 1925; Issued:  03- 05-10; Effective Date:  12 -09-09; Implementation Date:  04 -05-10)  Effective March 17, 2005, Medicare covers 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 is 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 is not technically possible, and not performed, then the procedure is not covered.   In addition to the specific patient indications, CMS determined that CAS with embolic protection is reasonable and necessary only if performed in facilities that have been determined to be competent in performing the evaluation, procedure, and follow -up ne cessary to ensure optimal patient outcomes.  CMS created a list of minimum standards modeled in part on professional society statements on competency.  All facilities must at least meet CMSs standards in order to receive coverage for CAS for high -risk pat ients.  Facilities must recertify every 2 years in order to maintain coverage of CAS procedures.   160.4  510k Post -Approval Extension Studies using 510k -Cleared Embolic Protection Devices during Carotid Artery Stenting (CAS) Procedures  (Rev. 11021; Issued: 10- 01-21; Effective: 10 -29-21; Implementation: 10 -29-21)  A. Background   As explained above in section 160.2, the Centers for Medicare & Medicaid Services (CMS) issued instructions in 2004 for processing claims for carotid artery stenting (CAS) procedures performed in Food and Drug Administration (FDA) -approved post -approval st udies. As the post -approval studies began to end, CMS received requests to extend coverage for the post -approval studies. As explained above in section 160.2.1, CMS reviewed the extension requests and determined that patients participating in post -approval  extension studies were also included in the covered population of patients participating in FDA -approved post-approval studies.   Recently, the FDA issued 510k approvals for proximal embolic protection devices (EPDs) which are utilized in CAS procedures. Utilization of an EPD is required in the Percutaneous Transluminal Angioplasty (PTA) national coverage determination (NCD) at Pub. 100- 03, chapter 1, section 20.7. However the 510k process does not involve a post - approval study requirement as traditional FDA marketing approvals require. CMS received requests to include patients participating in studies following the FDA 510k approval  of these devices under NCD 20.7. CMS subsequently determined that these patients, similar to patients covered in traditional post -approval extension studies, are eligible for coverage under the current coverage policy at NCD 20.7.  The FDA does not require devices approved through the 510k process to undergo further study following clearance. As such, 510k post -approval extension studies are neither required by the FDA or subject to FDA approval. However, for the purposes of study re view, the FDA evaluates traditional post -approval extension studies and 510k post - approval extension studies via the Pre -Investigational Device Exemption (IDE) process. As a result of the Pre- IDE process, each study is assigned and identified by a single, 6 -digit pre-IDE number, preceded by the letter I (i.e. I123456).  B. Policy   Effective October 22, 2010, CMS has determined that all 510k post -approval 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 510k post -approval extension study protocol, CMS will issue a letter to the study sponsor indicating that the study under review will be covered by Medicare. Since the FDA evaluates thes e studies via the Pre- IDE process, each 510k post -approval extension study will be identified by the I number assigned to the study when submitted to the FDA for review (i.e., the FREEDOM study examining the 510k- cleared Gore Flow Reversal System was ass igned I090962 and will be identified as such on all claims).  C. Billing   In order to receive Medicare coverage for patients participating in 510k post -approval extension studies, providers shall follow the same processes as explained above in section 160.2.1 (CAS for Post -Approval Studies). The only difference is that providers must report 510k- cleared devices with a pre- IDE number beginning with an I, instead of an IDE number beginning with a P (post -market approval).   Contractors will issue a letter assigning an effective date for each facilitys 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 utilizing  the most current ICD -10 CM procedure codes.   161 - Intracranial Percutaneous Transluminal Angioplasty (PTA) With Stenting  (Rev. 11021; Issued: 10- 01-21; Effective: 10 -29-21; Implementation: 10 -29-21)  A. Background   In the past, PTA to treat obstructive lesions of the cerebral arteries was non -covered by Medicare because the safety and efficacy of the procedure had not been established. This national coverage determination (NCD) meant that the procedure was also non -covered for beneficiaries participating in Food and Drug Administration (FDA) -approved investigational device exemption (IDE) clinical trials.   B. Policy   On February 9, 2006, a request for reconsideration of this NCD initiated a national coverage analysis. CMS reviewed the evidence and determined that intracranial PTA with stenting is reasonable and necessary under 1862(a)(1)(A) of the Social Security Act for the treatment of cerebral vessels (as specified in The National Coverage Determinations  Manual, Chapter 1, part 1, section 20.7 ) only when furnished in accordance with FDA - approved protocols governing Category B IDE clinical trials. All other indications for intracranial PTA with stenting remain non -covered.     Billing   Providers of covered intracranial PTA with stenting shall use Category B IDE billing requirements, as listed above in section 68.4. In addition to these requirements, providers must bill the appropriate procedure and diagnosis codes for the date of service to receive payment.   See the below ICD -10-CM diagnosis codes list applies, depending on the date of service. Indications for PTA and Stenting of Intracranial Arteries (must bill I67.2 and one of these primary codes to meet coverage under 20.7B5)  If ICD -10-CM is applicable: I67.2  Cerebral atherosclerosis  I66.01  Occlusion and stenosis of right middle cerebral artery  I66.02  Occlusion and stenosis of left middle cerebral artery  I66.03  Occlusion and stenosis of bilateral middle cerebral arteries  I66.11  Occlusion and stenosis of right anterior cerebral artery  I66.12  Occlusion and stenosis of left anterior cerebral artery  I66.13  Occlusion and stenosis of bilateral anterior cerebral arteries  I66.21  Occlusion and stenosis of right posterior cerebral artery  I66.22  Occlusion and stenosis of left posterior cerebral artery  I66.23  Occlusion and stenosis of bilateral posterior cerebral arteries  I66.8  Occlusion and stenosis of other cerebral arteries  I63.59  Cerebral infarction due to unspecified occlusion or stenosis of other cerebral artery    If ICD -10-PCS is applicable, ICD-10- PCS procedure codes.  That is, under Part A, providers must bill intracranial PTA using if ICD-10- PCS procedure codes is applicable.