Controversial Issues Related to Coding and Billing for Carotid Interventions Roseanne R. Wholey 2010

Roseanne R. Wholey, MD DISCLOSURES I have no real or apparent conflicts of interest to report.

Carotid Stenting In the U.S. - slowed down due to the reluctance of insurance carriers to reimburse doctors who use them. For many years physicians performing these procedures were scrutinized by carriers with strict policy requirements.

Psalm 23 “Yea, though I walk through the valley of the shadow of death, I will fear no evil”

Who let the dogs out? FDA - Food and Drug Administration IRB - Institutional Review Board CMS - Centers for Medicare & Medicaid

History In the early 1980’s PTA for non-coronary vessels was generally accepted. There was no HCFA national non-coverage policy and as a result Medicare contractors had discretion in determining coverage for these procedures.

1984 The trouble begins In 1984, due to concerns of safety and efficacy, HCFA issued a NATIONAL NON-COVERAGE POLICY for PTA for the treatment of obstructive lesions of the aortic arch vessels.

They subsequently revised the policy that same year to cover obstructive lesions of a single coronary artery, the upper extremity (EXCLUDING HEAD AND NECK VESSELS), the renal artery and AV dialysis fistulas and grafts.

In 1995 HCFA issued regulations related to Medicare coverage of certain devices with an IDE approved by the FDA. For Category B devices HCFA permitted Medicare contractors to consider coverage on a local basis for Cat B devices with an IDE approved clinical trial protocol.

In 1997 HCFA expressed their belief that the non-coverage policy should continue but that a randomized clinical trial would be the best mechanism for compiling clinical data. It was decided that, due to the non-coverage status of the PTA, stents used during carotid PTA should not be covered.

In July 2000 President Clinton issued a memorandum to increase participation of Medicare beneficiaries in clinical trials and authorized Medicare payment for routine patient care costs and costs due to complications associated with participation in clinical trials. On 9-19-00 the Medicare Clinical Trials Policy went into effect.

A decision was made for Medicare to cover PTA of the carotid artery concurrent with stent placement when furnished in accordance with FDA approved protocols governing Category B IDE approved clinical trials, effective July 1, 2001.

2004 codes for physician services performed as part of a clinical trial Category III (emerging technology) Codes at that time were: 0005T Transcatheter placement extracranial cerebrovascular stent(s) initial (includes PTA procedure of the stented vessel & reported one time regardless of the number of stents placed in same ves’l) 0006T Each additional vessel 0007T S&I report separately each vessel

2004 reimbursement 0005T Initial stent $220.65 0006T Stent ea add’l ves’l $0 0007T S&I $ 45.26 No RV units assigned to tracking codes. Payment based on policies of payors and not a yearly fee schedule.

Vertebral/Cerebral PTA of vertebral and cerebral arteries was not covered

Embolic Protection There were no Category I codes to describe the use of embolic protection devices

FDA APPROVAL FOR CAROTID ARTERY STENTING On 8-31-04 the FDA granted approval for carotid artery stenting. This is the first approval the FDA has granted for CAS in the U.S. (for high risk patients who have had symptoms of a stroke or who have a carotid artery blockage of at least 80% and who are not good candidates for endarterectomy.)

On 12-17-04 CMS announced a proposed rule to provide coverage for CAS with DEP reversing their previous national non-coverage policy. But the decision did not immediately change the non-coverage policy and there are conditions to be met for coverage to be provided.

Medicare National Coverage Determination: Medicare limiting coverage to: High Risk symptomatic patients with carotid artery narrowing of 70% or more required use of approved CAS systems use of approved or cleared emb prot devices

Medicare will also cover patients who meet the FDA-labeled criteria for carotid stents, who are at high risk for carotid endarterectomy and have symptomatic carotid artery stenosis between 50-70% and asymptomatic carotid artery stenosis of 80% or more, in Category B IDE clinical trials, as a routine cost under the clinical trials policy, or in post-approval studies.

Diagnosis Requirement Claim data must include the diagnostic code 433.10, carotid stenosis or occlusion without infarct The determination that a patient is at high risk for CEA and the patient’s symptoms of carotid artery stenosis should be available in the patient medical record prior to performing any procedure

Inpatient requirement Carotid artery stenting is only covered as an inpatient service

Physician Services The previous Category III tracking codes for carotid stenting are no longer valid

2005 Category III codes for extracranial, vertebral or intrathoracic CAS Category III emerging technology codes: 0075T Transcatheter placement of extracranial, vertebral or intrathoracic carotid artery stent(s) including S&I percutaneous, initial vessel 0076T “ each additional vessel

2005 Category I CPT codes Codes released in November 2004 for implementation in 2005: 37215 Transcatheter placement of intravascular stent(s) cervical carotid artery, percutaneous w/distal protection 37216 “ without distal protection (as there will be times that distal protection cannot be successfully completed)

BUT... CMS dropped coverage for 37216 (w/o dp) The change was retroactive to 3-17-06 (the same day that CMS expanded national coverage which apparently restricted coverage to stents w/distal protection Carriers don’t have to retract payments already made - unless claims come to their attention

ABN If the pt would benefit by a carotid stent w/o distal protection you can offer an “advance beneficiary notice” explaining that the services are not covered and the patient is responsible for payment

2007 Medicare Reimbursement 37215 - $1,020.11 2008 Medicare Reimbursement 37215 - $914.31 2009 Medicare Reimbursement 37215 – $1077.96 2010 Medicare Reimbursement 37215 - $1137.90

Problem: 37215 = Bundled code If an ipsilateral angiogram confirms the need for CAS, code 37215 includes all ipsilateral selective carotid catheterization, all cervical and cerebral diagnostic imaging and S&I services

THERAPEUTIC INTERVENTION CATH Right common carotid cath DIAGNOSTIC IMAGING Unilateral carotid cervical Unilateral carotid cerebral THERAPEUTIC INTERVENTION Right carotid stenting w/embolic protection

CPT CODE: 37215

However... If a diagnostic study is performed and carotid stenting is not performed then the appropriate codes for carotid catheterization and imaging should be reported instead of code 37215

Interventional Component Coding allows for the separate coding of: Catheter Placement Radiologic imaging services Transcatheter Therapies Radiologic supervision and interpretation

In each vascular family the catheter placement is coded to the highest order branch UPPER EXTREMITY CODES: 36215 - First order upper extremity (ex: normal anatomy-left subclavian, left common carotid, innominate) 36216 - Second order (right subclavian, right common carotid, left internal, left external, left vertebral) 36217 - Third order (right vertebral, right internal, right external)

36218 - Each additional second or third order upper extremity catheter placement within a vascular family (list in addition to the code for the initial second or third order vessel as appropriate)

A non-selective catheter placement into the aorta would not be coded separately in addition to a selective catheter placement Selective catheter placement in different vascular families can be coded separately (modifier -59 is required by most payors to distinguish separate procedures)

Radiologic supervision and interpretation frequently used for carotid procedures: 75650 - Arch 75665 - Unilateral cerebral carotid 75671 - Bilateral cerebral carotids 75676 - Unilateral cervical carotids 75680 - Bilateral cervical carotids 75685 - Unilateral vertebral 75685 X 2 - Bilateral vertebrals

CATHS DIAGNOSTIC IMAGING Right and left common carotid arteries* Cervicocerebral arch Bilateral carotid cervical Bilateral carotid cerebral *do not use -50 bilateral modifier

CPT CODES/MODIFIERS PROCEDURE FEE SCHED/RED 2010 36216-RT Second order cath 283.40 283.40 36215-LT-59 First order cath 251.10 125.55 75680-26 Bilateral carotid cervical 83.96 83.96 75671-26 Bilateral carotid cerebral 83.24 83.24 75650-26 Cervicocerebral arch 74.81 74.81 ________ _______ TOTAL 776.51 650.96

CATHS DIAGNOSTIC IMAGING Right and left vertebral* Right and left common* DIAGNOSTIC IMAGING Bilateral carotid cervical Bilateral carotid cerebral Bilateral vertebral *do not use -50 bilateral modifier

CPT CODES/MODIFIERS PROCEDURE FEE SCHED/RED 2010 36217-RT Third order cath 335.75 335.75 36216-LT-59 Second order cath 283.40 141.70 36215-LT-59 First order cath 251.10 125.55 36218-RT Ea add 2nd/3rd order cath 53.55 53.55 75680-26 Bilateral carotid cervical 83.96 83.96 75671-26 Bilateral carotid cerebral 83.24 83.24 75685-26X2 Bilateral vertebral 66.36 66.36 66.36 66.36 ________ ________ TOTAL 1223.72 956.47

QUESTION Can you ever bill for both a diagnostic carotid procedure along with carotid artery stenting?

LT and Rt common carotid caths, bilateral cerebral and cervical a’gms, LT carotid stenting w/emb protection 37215-LT Stent w/distal protection 36216-RT 2nd order cath placement 75665-26 Unilateral cerebral a’gm 75676-26 Unilateral cervical a’gm

CPT CODES/MODIFIERS PROCEDURE FEE SCHED/RED 2010 37215LT Stent w/dist protection 1137.90 1137.90 36216RT Second order cath 283.40 141.70 75665-26 Unilat carotid cerebral 66.81 66.81 75676-26 Unilat carotid cervical 66.81 66.81 ________ ________ 1554.92 1413.22

Which would you choose? It is obvious!