MIR-2006-8AB, August 2006

Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting

The Centers for Medicare & Medicaid Services (CMS) has expanded the National Coverage Determination (NCD) on Percutaneous Trans-luminal Angioplasty pertaining to carotid artery stenting.

For complete details on coverage, refer to the “MedLearn” articles posted on our Web site on 05/11/2005, 09/26/2005, and 05/23/2006, as well as in the Medicare National Coverage Determina-tions Manual, Pub. 100-3, Chapter 1, Part 1, Section 20.7; available at http://www.cms.hhs.gov/manuals/downloads/ncd103c1_Part1.pdf on the CMS Web site.

In order to place the coding instructions in context, it is helpful to review the chronological evolution of the coverage for this service.

• Percutaneous transluminal angioplasty of the carotid artery with concomitant stent place-ment became a covered service on July 1, 2001, if performed in accordance with an FDA-approved protocol for Category B Investigation Device Exemption (IDE) trial.
• For dates of service October 12, 2004 and after, the coverage was expanded to include FDA-approved devices that were utilized for services rendered in accordance with an FDA protocol for post-approval studies.
• For dates of service March 17, 2005 and after, the coverage is further expanded to allow PTA of the carotid artery concurrent with placement of an FDA-approved carotid stent with embolic protection for patients who are considered to be at high-risk, provided the services are rendered at a CMS-approved facility.
• For dates of service February 28, 2006 and after, the Centers for Medicare & Medicaid Services (CMS) has determined that all post-approval extension studies must be reviewed by the Food and Drug Administration (FDA).

Coverage of services rendered in accordance with an investigational device exemption (IDE), an FDA protocol for post-approval studies, and the FDA-reviewed post-approval extension studies will be considered based on information concern-ing the device, the clinical study, and the partici-pating Medicare providers.

All of the following information must be provided to the carrier before approval can be considered for the Category B IDE clinical trials and the FDA-required post-approval studies:

1. A cover letter requesting the coverage for both Part A and Part B. The letter must identify the name of the study, the IDE#, the list of partici­pating providers with provider numbers, and the name and PIN number of the institution at which the study will be conducted. The letter must be cosigned by the clinical investigator or research coordinator and an official representing the institution (hospital).
2. A copy of the FDA approval letter provided to the sponsor or manufacturer of the device. The approved IDE number must be on the letter.
3. Clinical protocol containing:

• Reports of prior investigations
• Brief description of the study design
• Number of patients and duration of study
• Criteria for patient selection
• Description of the control group
• The total number of institutions or centers included in the study
• Primary outcome measures
• Principal results
• A copy of the actual protocol
• Copies of supporting articles published in peer reviewed literature.

4. An outline or schedule of services which includes:

• Places of service
• Suggested ICD-9-CM codes
• Listing of all services that will be billed to Medicare (CPT and HCPCS codes)
• Expected frequency of services

5. A sample of the informed consent presented to participating beneficiaries.
6. Investigation agreement:

• A copy of the sponsor’s investigation agreement
• The curriculum vitae of each investigator in printed form

7. Institutional Review Board (IRB) information, which includes:

• IRB study approval information
• Identity of the chair of the IRB
• IRB protocol
• Expiration date of the IRB approval

8. Manufacturing information:

• Name of device, both trade and common, or usual classification name
• Packaging and storage information
• Installation information

9. Sales information, which includes:

• A statement from the sponsor as to whether the device is sold discounted, or donated to the institution
• A statement from the sponsor disclosing any administrative fees given to the institution
• A statement from the sponsor disclosing any fees given to the participating provider, itemizing the specific reason for each fee
• A statement from the sponsor disclosing any fees given to the participating beneficiary

10. Statement from the institution (hospital) acknowledging participation in the study.
11. Other information (if applicable).

In addition, the following items must also be submitted to the carrier when requesting approval of the Post-Approval Extension Studies:

1. A copy of the FDA acknowledgement letter for the extension study.
2. A copy of the letter from CMS providing coverage for the extension study.
3. The effective date for each facility’s participa-tion in the extension study.

The following are coverage and coding instructions:

Appropriate CPT/HCPCS Codes

ICD-9-CM Codes that Support Medical Necessity

Other Coding Guidelines:

1. Imaging studies that are an intricate part of the procedure or done in conjunction with the procedure are not separately payable as diagnostic studies and should not be coded.
2. The services may not be done in conjunction with any cardiac catheterization unless there are cardiac symptoms or indications that justify simultaneous evaluation.
3. The listed HCPCS codes describe the angioplasty, stenting, stenting with distal protection, radiological supervision accompanying the procedure, or a range code combing both the stenting and radiological supervision. All of these codes may be reported with an appropriate introduction code (36216). All codes must have the RT or LT modifier appended. However, the selection of reportable codes is dependent on the date of service and the FDA status of the trial.
4. Services furnished in an IDE clinical trial for dates of service on or after July 1, 2001.

• Registration as a provider utilizing a Category B device in an IDE trial must be submitted and approval must be obtained prior to the submission of claims for this procedure.
• Use ICD-9-CM code 433.10.
• Claims must be reported with the QA modifier. The QA modifier is appended only to the codes specifically associated with the application of the device.
• Claims must be reported with the IDE number (preceded by a “G” plus six digits), assigned by the FDA. This number must be entered in Item 23 of the CMS-1500 claim form or in the elec­tronic equivalent.
• Use CPT codes 0075T and 0076T to report the transcatheter placement of the INTRATHO­RACIC CAROTID ARTERY stent(s) and the supervision and interpretation when performed as part of an IDE clinical trial on or after 01/01/2005.
• Use CPT codes 37215 and 37216 (code 37216 is covered only for dates of service prior to 03/17/2005) to report the transcatheter placement of the CERVICAL CAROTID ARTERY stent(s) and the supervision and interpreta­tion when performed as part of an IDE clinical trial on or after 01/01/2005.
• CPT codes 0075T, 0076T, 37215, and 37216 (code 37216 is covered only for dates of service prior to 03/17/2005) include the radiological supervision and interpretation. Therefore, supervision and interpretation codes 75671 and 75680 must NOT be reported separately.

5. Services furnished in accordance with FDA-approved protocols governing post-approval studies for dates of service on or after October 12, 2004.

• Registration as a provider placing an FDA-approved carotid stent furnished in accordance with FDA-approved protocols governing post-approval studies must be submitted and approval must be obtained prior to the submission of claims for this procedure.
• Claims reporting CPT code 37799 must include the statement “carotid artery stenting–post-approval studies” in Item 19 of the CMS-1500 claims form, and for electronic claims submissions, this statement must be entered in either the 2300 (claim) or the 2400 (line) Loop in the NTE Segment.
• Use ICD-9-CM code 433.10.
• Claims must be reported with the QA modifier. The QA modifier is appended only to the codes specifically associated with the application of the device.
• Claims must be reported with the post-approval number (preceded by a “P” plus six digits) assigned by the FDA. This number must be entered in Item 23 of the CMS-1500 claim form or in the electronic equivalent.
• Use CPT code 37799 on or after 10/12/2004 to report the angioplasty and placement of an FDA-approved carotid stent, including supervision and interpret-tation, done under FDA protocol for post-approval studies.
• CPT code 37799 includes the radiological supervision and interpretation. Therefore, supervision and interpretation codes must NOT be reported separately.
• Services rendered for this coverage and billed with CPT code 37799 include a 90-day global period.
• Services rendered for this coverage and billed with CPT code 37799 will be reimbursed at an allowance equal to that of CPT code 37215.

6. Services for PTA of the carotid artery
   concurrent with the placement of an FDA-approved carotid stent with embolic
   protection for patients who are at high-risk when services are performed at a CMS-approved facility, effective 03/17/2005.

• Use CPT codes 37215, 37216 (code 37216 is covered only prior to date of service on or after 03/17/2005), 0075T and 0076T.
• Do NOT report a supervision and interpretation code.
• Use ICD-9-CM code 433.10.
• The name of the facility must be entered in Item 32 of the CMS-1500 claim form.
• Services will only be allowed when dates of service are on or after the date that the facility is added to the approved list on CMS’s Web site.

7. Services furnished in accordance with FDA-approved protocols governing post-approval EXTENSION studies for dates of service on or after February 28, 2006.

• In addition to registration as a provider utilizing a Category B device in an IDE trial, all of the following information must also be submitted to the carrier for approval prior to the submission of claims for this procedure:
  • A copy of the FDA acknowledgement letter for the extension study.
  • A copy of the letter from CMS provid-ing coverage for the extension study.
  • The effective date for each facility’s participation in the extension study.
• Claims reporting CPT code 37799 must include the statement “carotid artery stenting – EXTENSION studies” in Item 19 of the CMS-1500 claim form, and for electronic claims submissions, this statement must be entered in either the 2300 (claim) or the 2400 (line) Loop in the NTE Segment.
• Use ICD-9-CM code 433.10.
• Claims must be reported with the QA modifier. The QA modifier is appended only to the codes specifically associated with the application of the device.
• Claims must be reported with the post-approval number (preceded by a “P” plus six digits) assigned by the FDA. This number must be entered in Item 23 of the CMS-1500 claim form or in the electronic equivalent.
• Use CPT code 37799 on or after 02/28/2006 to report the angioplasty and placement of an FDA-approved carotid stent, including supervision and interpret-tation, done under FDA protocol for post-approval studies.
• CPT code 37799 includes the radiological supervision and interpretation. Therefore, supervision and interpretation codes must NOT be reported separately.
• Services rendered for this coverage and billed with CPT code 37799 include a 90-day global period.
• Services rendered for this coverage and billed with CPT code 37799 will be reimbursed at an allowance equal to that of CPT code 37215.

8. All services with their applicable CPT codes must be submitted on the same claim.
9. The service may be performed only in the hospital (21).

This article supersedes the previous article posted on Empire Medicare Services’ Web site on 09/26/2005 and published in the Medicare News Brief issue MNB-2006-1 (January 2006).

Reference:
CMS Change Request (CR) 3489 (Transmittal 314, dated October 12. 2004)
CMS Change Request (CR) 5022 (Transmittal 53, dated April 21, 2006)
CMS Change Request (CR) 5088 (Transmittal 951, dated May 12, 2006)