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Pre-market approval (PMA), PMA post-approval studies, pre-market notification (PMN) 510(k), and 510(k) post-approval extension studies
Last Modified: 7/24/2024
Location: FL, PR, USVI
Business: Part A, Part B
Note: No PMA, post-approval studies, or PMNs should be submitted to the Medicare Administrative Contractor (MAC) for approval.
The information provided below is related only to percutaneous transluminal angioplasty (PTA) with carotid artery stenting (CAS) procedures.
Please refer to the following CMS guidelines for more information:
Medicare covers percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stent placement when furnished in accordance with the Food and Drug Administration (FDA) protocols governing Category B Investigational Device Exemption (IDE) studies.
The billing for this procedure is based upon how the service is delivered. There are several CPT codes that may be billed depending upon how the procedure is performed.
MACs must ensure that payment is provided for claims for PTA in an FDA-approved clinical study and deny any claims for services for PTA of the carotid artery when provided outside of an FDA-approved clinical study in accordance with National Coverage Determination (NCD) 20.7.
As a requirement for Category B IDE coverage, providers must bill a six-digit IDE number that begins with a “G” (e.g., G123456). To identify the line as an IDE line, institutional (Part A) providers must bill this IDE number on a 0624 Revenue Code line while practitioners (Part B) must bill this IDE number along with a Q0 modifier. Please refer to
Billing and Coding of Routine Costs (JN) for more information on billing IDEs.
Additional information on IDEs and clinical trials can also be found in:
PMA (Pre-market approval)
• PMA is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of Class III devices.
• PMA is the most stringent type of device marketing application required by FDA. The applicant must receive FDA approval of its PMA application prior to marketing the device.
• The PMA applicant is usually the person who owns the rights, or otherwise has authorized access, to the data and other information to be submitted in support of FDA approval.
• billing and coding guidelines
• FDA-approved PMA device is assigned an identification code by the FDA, which enables MACs to establish special claims processing procedures associated with each study.
General claim submission
Part A billers:
• no more than one PMA number in form locator 43 of the CMS-1450 paper form or in 2300 IDE Number Ref Segment, data element REF02 (REF01=LX) of the 837i;
• revenue code 0624 for post-approval study devices in form locator 42 of the CMS-1450 paper claim form or 2400 Institutional Service Line SV201 Segment, data element 234 of the 837i;
• an appropriate ICD-10 diagnosis code; and
• the inpatient procedure codes.
• Providers must bill the appropriate procedure and diagnosis codes to receive payment. That is, under Part A, Providers must always ensure they are using the latest and most appropriate codes. Please refer to:
• Claims Processing Manual Chapter 32 
, section 160 – PTA for implanting the carotid stent and section 161-Intracranial Percutaneous Transluminal Angioplasty (PTA) with stenting.
Note: Providers billing Part A must bill using the most current HCPCS and ICD-10 diagnosis code(s).
• revenue code is 0624.
• PMA device must have a related HCPCS code for pricing purposes. The related PMA device number and HCPCS submitted on a claim will be edited against a master file which is furnished by CMS.
• PMA device number and the ICD-10 diagnosis codes should relate.
• PMA device number should be placed on the 837i electronic claims format 2300 Investigational Device Exemption Number REF Segment, data element REF02 (REF01=LX).
• for a PMA device provided to a hospital patient is no different than payment for a FDA approved device. Deductible and Co-insurance apply.
• for a PMA device in an inpatient setting is included in the DGR payment.
Part B billers:
• no more than one PMA number (that begins with a “P” followed by six digits) in either item 23 of the CMS-1500 paper claim format or in the 2300 IDE (Investigational Device Exemption) Number Ref Segment, data element REF02 (REF01=LX) of the 837p claim format;
• the QA modifier to reflect PTA post-approval study devices claim;
• HCPCS code 37799, unlisted procedure, vascular surgery, as the procedure code; and
• appropriate ICD-10 diagnosis code.
Post-approval studies
• covers PTA of the carotid artery concurrent with the placement of an FDA-approved carotid stent and an FDA-approved or cleared embolic protection device for an FDA-approved indication when furnished in accordance with FDA-approved protocols governing post-approval studies.
• post-approval studies is similar to normal Category B IDE billing procedures, except that under post-approval coverage, providers must bill the PMA number assigned to the stent system by the FDA. PMA numbers related to CAS procedures are like typical IDE numbers in that they have six digits, but they begin with a “P” (e.g., P123456) instead of a “G.
Post-approval studies billing and coding guidelines
In order to receive Medicare coverage for patients participating in post-approval studies, providers should refer to CMS Intranet-Only Manual (IOM), Publication 100-04, Medicare Claims Processing Manual, Chapter 32 – Billing Requirements for Special Services, Section 160.2.1-Carotid Artery Stenting (CAS) for Post-Approval Studies for billing information and the general claim submission guidelines below.
General claim submission
• billing A/B MACs (A) must bill using the most current ICD-10-CM applicable, Indications for PTA of the Carotid Artery Concurrent with Stenting (must bill one of the primary codes listed in IOM Medicare Claims Processing Manual, Chapter 32, Section 160.2.1 referenced above to meet coverage under NCD 20.7B2, 20.7B3, 20.7B4); and
• appropriate TOB (Type of Bill);
• appropriate procedure code;
• Modifier Q0 and/or Q1 as appropriate (outpatient claims only);
• Condition code 30 (qualifying clinical trial);
• value code D4 which indicates you are reporting a NCT (National Clinical Trial) number;
• the appropriate valid 8-digit NCT number; and
• revenue code 0278 (Medical/surgical supplies and devices – Other Transplant), along with the billed charge.
PMN (Pre-market notification) is also called a 510(k)
• is a pre-market submission to FDA described under 21 CFR 807 Subpart E in which the applicant must establish that their device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807) that is not subject to premarket approval. This type of submission is used for most Class II devices and some Class I devices.
• 510(k) post-approval extension studies related to embolic protection devices during CAS procedures is identified by a “K”, “I”, or “Q” followed by a six-digit study number. For example: K110838, I234567, or Q123456.
• has determined that the FDA must review all 510(k) post-approval extension studies through its Pre-IDE process. As a result of this process, each study is assigned and identified by a single, six-digit number preceded by the letter ‘I’ (e.g., I123456). (For example, the FREEDOM study, examining the 510(k)-cleared Gore Flow Reversal System, was assigned I090962 and must be identified as such on all claims.)
• Sometime in 2012 the FDA changed the “I” to a “Q” for Pre-IDE clinical studies. The “I” is still valid, however moving forward the “I” will no longer be assigned to a Pre-IDE. At this time there is no “Draft Guidance” documentation on pre-submissions. The “Draft Guidance” is in the process of being finalized. If you have any questions please call 800-638-2041.
• note that if you perform clinical trials with your 510(k) device, you are subject to the IDE Regulation (
21 CFR 812)
.
• Post-approval extension studies billing and coding guidelines
In order to receive Medicare coverage for patients participating in 510K post-approved extension studies, you will need to follow the billing guidelines outlined in the Medicare Claims Processing Manual, Chapter 32, Section 160.2.1 and report the 510K cleared device with a pre-IDE number beginning with an ‘I’, instead of an IDE number beginning with a ‘P’.
General claims submission
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 PMA billing and coding guidelines.
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).
• A billers:
• Use the most current procedure code(s);
• Place no more than one IDE number (that begins with an ‘I’) in form locator 43 of the CMS-1450 paper claim form or in 2300 IDE Number REF Segment, data element REF02 (REF=LX) of the 837i electronic format;
• Use revenue code 0624 for post-approval study devices in form locator 42 of the CMS-1450 paper claim form or 2400 Institutional Service Line SV201 Segment, data element 234 of the 837i electronic format; and
• Use the most current ICD-10 diagnosis code(s).
• B billers:
• Place the IDE number (that begins with an ‘I’) in either item 23 of the CMS 1500 claim form or in the 2300 IDE Number REF Segment, data element REF02 (REF=LX) of the 837p electronic format;
• Use the Q0 modifier; and
• Use the most current procedure and diagnosis codes.
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