HCPCS LEVEL II CODE MODIFICATION REQUEST PROCESS 

RE: The 2013 HCPCS Update 

The Healthcare Common Procedure Coding System (HCPCS) Level II contains alphanumeric codes used to identify items (and sometimes, services) that are not included in the 

HCPCS Level I (American Medical Association's CPT) code set. 

As a preliminary step in the process for recommending a modification to the HCPCS Level 

II coding system, it may be helpful for you to contact 3rd party payers for Medicare, 

Medicaid and private insurers to determine if, in their determination, existing HCPCS codes 

identify the item. 

You may submit a recommendation to establish, revise or discontinue a code, using the 

attached, standard format. Please prepare a cover letter outlining your code request and a 

brief summary of why the code modification is needed. In addition to providing the 

information according to the format, please include descriptive material, which you think 

would be helpful in furthering our understanding of the medical benefits of the item for 

which a coding modification is being recommended. Submit the original request with 

supporting documentation and, to expedite distribution and review, please also include 35 

complete copies of your recommendation information packet. At this time, we are not able 

to accommodate electronic requests, and all originals requests and copies must be submitted 

on paper. 

In order to ensure timely review of your materials, it is necessary to limit your 

recommendations to no more than 40 pages. PLEASE INCLUDE BOTH QUESTIONS 

AND ANSWERS ON YOUR APPLICATION. Applications exceeding 40 pages will not 

be accepted and must be trimmed to no more than 40 pages and resubmitted by the applicant 

by the application deadline. Applicants making a claim of significant therapeutic distinction 

to distinguish a product from an existing code category may find a need to exceed the 40-

page limit in order to submit relevant substantiating clinical information. In these cases 

only, the applicant may provide one reference copy of each article in addition to 35 copies of 

the application. Each side of a page, including brochures, booklets and any other inclusions, 

counts as page in calculating the 40 page limit. The completed, signed and dated format, 

FDA (approval letter or explanation of exemption), supporting documentation, product 

brochures and/or booklets should be bundled securely to ensure that all the information 

submitted is distributed intact to all reviewers. Please note that FDA approval for drug 

coding applications may be submitted after the initial application but no later than March 

31st. Please do not use bulky materials, such as 3-ring binders, to fasten recommendation 

materials, as this may result in difficulties distributing materials to reviewers. To ensure that 

applications are not overlooked, separate applications should be submitted in different 

packages. 

We do not require or ask for samples. However, many applicants ask if they may send 

product samples, video tapes or compact discs as a supplement to their application. If it is 

practical and feasible for an applicant to submit a sample with their application, they may 

voluntarily do so, however, it becomes the property of CMS to keep or dispose of as the 
agency sees fit. If the applicant chooses to send samples, video tapes, or compact discs, 

please send no more than 3.

When the recommendation is received, it is distributed to all reviewers. All timely and 

complete recommendations are placed on HCPCS Meeting Agendas and reviewed at 

regularly scheduled meetings by a panel whose membership includes representatives of 

Medicaid, Medicare, Private Insurers and the Veteran’s Administration health care system. 

All external recommendations, (e.g. requests not generated internally) will be placed on a 

Public Meeting Agenda together with the preliminary HCPCS coding decision. The HCPCS 

Public Meetings provide an open forum for interested parties to make oral presentations or 

to submit written comments in response to published preliminary coding decisions. A 

Federal Register notice will be published to announce dates, times and the location of the 

public meetings. We will also post on CMS’ official HCPCS website at 

www.cms.gov/medhcpcsgeninfo the dates, times, agendas, preliminary coding 

recommendations, registration information and guidelines for participation in HCPCS Public 

Meetings. Although the Public Meetings are not decision-making meetings, they provide an 

opportunity for applicants and the general public to react to preliminary coding decisions 

and share additional information with decision makers, prior to final decisions.

All applicants will be notified, in writing, of the final decision on their application by midNovember 2012, and all modifications to the HCPCS codes set will be incorporated into the 

2013 HCPCS Level II Annual update. The Update will be published on the official HCPCS 

worldwide website at www.cms.gov/medhcpcsgeninfo by mid November, 2012.

To be considered for inclusion in the year 2013 HCPCS update, completed recommendation 

packets must be received no later than close of business (COB) Monday, January 3, 2012. 

The HCPCS coding review process is an ongoing, continuous process. Requests may be 

submitted at anytime throughout the year 2011, and up to January 3, 2012. Early 

submissions are strongly encouraged. Requests that are complete are reviewed and 

processed on a first come, first served basis. At CMS’ discretion, incomplete 

recommendations may be returned or held until required information, as notified, is 

provided and the request is completed. Only complete code requests are entered into the 

review cycle. Applications for products/services that are not yet available on the U.S. market 

will be considered incomplete. Recommendations received or completed on or after 

COB January 4, 2012 and those requiring additional review will be considered for 

inclusion in a later HCPCS update. Applications exceeding the 40-page limit are not 

acceptable with the single exception as noted on page 1 of these instructions and in 

question 7c of this application.

For additional information regarding the HCPCS coding process or the application process, 

you may: 1) review documents on website at www.cms.gov/medhcpcsgeninfo ; 2) submit an 

inquiry to HCPCS@cms.hhs.gov; or 3) contact CMS HCPCS staff; Felicia Eggleston, at 

(410) 786-9287; Jennifer Carver at (410) 786-6610; or Geneva Harkness at (410) 786-6951.
Healthcare Common Procedure Coding System (HCPCS) 

Alpha-Numeric Coding Recommendation Format for the 2013 Update 

Instructions: 

1. Please sign and date each recommendation. Be certain to provide the name, 

complete address and direct telephone number of the person to be contacted 

regarding this recommendation. We use this information to contact applicants 

regarding upcoming meetings, questions regarding applications, and to make 

notifications of the status of applications. Please be sure that your system can 

receive emails from cms.hhs.gov.

2. Please provide documentation of the item's current classification by the Food and 

Drug Administration (FDA). Include a copy of the cover page from the initial 

FDA application and a copy of the FDA's determination, notification/approval 

letter. If the drug/biological/product/service has been subject to an assessment by 

any other agency or recognized medical body, provide a copy of the results of that 

assessment. Note: Documentation of FDA approval of a drug or biological may 

be submitted after the coding application but no later than March 31st, provided all 

other requested information is complete and submitted by the deadline.

3. Please note: All requested information must be supplied before your

recommendation for modifications to the HCPCS coding system can be 

considered. The following questions may be transferred to a word 

processor/computer to allow space to respond fully and completely. All questions 

must be answered. "N/A" is not an acceptable response. If the question does not 

appear to apply, provide a detailed explanation as to why it doesn't apply. 

Incomplete submittals will not be accepted. 

4. Submit Coding Recommendations to: 

Felicia Eggleston, CMS HCPCS Workgroup Coordinator 

Centers for Medicare and Medicaid Services 

C5-08-27 

7500 Security Blvd 

Baltimore, Maryland 21244-1850 
Alpha-Numeric HCPCS Coding Recommendation Format

INFORMATION SUPPORTING CODING MODIFICATION RECOMMENDATION 

1. For the purpose of publication on our request list and public meeting agenda on the 

HCPCS website, please provide a brief summary of your request (not to exceed 300 

words). In this summary, please specify your request to modify the HCPCS code set: 

(e.g. number of new codes requested, recommended language; revise a code (provide old 

language and recommended language), discontinue a code). Include the name of the 

product, description, function, and the reason why existing codes do not adequately 

describe your product. For drugs, include the indications for use, action, dosage and 

route of administration, and how supplied. Text that exceeds the 300-word limit may be 

truncated and not appear on our published summary, therefore, it is important to provide 

a concise summary within the 300-word limit. CMS may edit your summary prior to 

publication.

2. Identify the Item (product or drug/biological) for which a Level II HCPCS Code is 

being requested.

A) Trade or Brand Name: 

B) General Product Name or Generic Drug Name (active ingredient): 

C) FDA classification: 

3. Please check one HCPCS category from the following list, which most accurately 

describes the item identified in question #1: 

__ A) Medical/Surgical Supplies 

__ B) Dialysis Supplies and Equipment 

__ C) Ostomy/Urological Supplies 

__ D) Surgical Dressing 

__ E) Prosthetic

__ F) Orthotic 

__ G) Enteral/Parenteral Nutrition 

__ H) Durable Medical Equipment 

__ I) Blood/Blood Products 

__ J) Drug/Biological

__ K) Radiopharmaceutical 

__ L) Vision 

__ M) Hearing 

__ N) Other (please indicate/provide category)_________________________________ 

4a.) Is the item durable, if so, explain how it can withstand repeated use? 

Specify whether the entire item or only certain components of the item can withstand 

repeated use:
4b.) If the entire item can withstand repeated use, then please specify the length of the 

time that the item can withstand repeated use.

4c.) If only certain components of the device can withstand repeated use, then please 

identify the individual components and the length of the time that the individual 

components can withstand repeated use.

4d.) Please provide detailed information on the warranty of the device such as the parts 

included under the warranty, the length of the warranty and the parts excluded from the 

warranty. In addition, please specify if the device includes any disposable components 

and the expected life or the replacement frequency recommended for the disposable 

components.

5. Describe the item fully in general terminology. What is it? What does it do? How is it

used? Describe the patient population for whom the product is clinically indicated. 

Descriptive booklets, brochures, package inserts, as well as copies of published peerreviewed articles on the item may be included in the information packet submitted for 

review, but they do not replace the requirement to fully respond to this question and fully 

describe the item. 

For drugs and biologicals, include: A) indications for use, B) action, C) dosage and route 

of administration, D) package insert and, E) how supplied. 

6. Describe how the item/product is primarily and customarily used to serve a medical

purpose.

7a) Identify similar products and their manufacturers. 

(If a drug - list other drugs by trade name marketed under the same active ingredient 

category/generic name.) 

7b) Identify significant differences between this item and other products listed above. 

(Include differences in item cost; material; product design; how it is used; different 

mechanism of operation, differences in function/treatment provided to a patient; clinical 

indication; and clinical outcome.) 

7c) Complete item 7C only if you are making a claim of significant therapeutic 

distinction). Claims of significant therapeutic distinction when compared to the use of 

other, similar items, must be described in detail. Articulate the clinical theory behind the 

claim, including differences in the product or its operation as it compares to currently 

coded products. Specify how the product results in a significantly improved medical 

outcome or significantly superior clinical outcome. (Please refer to the HCPCS decision 

tree for additional information.) Provide the best available information related to your 

claim. Include copies of all articles that result from your systematic analysis of the 

available literature. Information submitted should be as complete as possible.

Unfavorable articles should be provided with any appropriate rebuttal or explanation. If 

the articles submitted cause you to exceed the overall 40-page limit, then submit one 

reference copy of each article and 35 copies of the application.

8. Answer each of the questions A), B), and C) below:

A) List any 3rd party payers that pay for this product 

B) List any codes that are currently being billed to those payers for this product.
C) Explain why existing code categories are inadequate to describe the item.

9. A) Is this product prescribed by a health care professional? 

 B) If yes - who prescribes the product and in what setting(s) is the product prescribed?

10. A) Is the item useful in the absence of an illness or injury?

 B) Explain: 

11a.) Provide the date that the item/product was cleared for marketing by the FDA. If the 

product is exempt from FDA review and classification, please explain the basis 

for the exemption.

b.) Attach copy of the FDA approval letter including the 510(k) summary for those items 

that are approved using the 510(k) process. Also, if an item is cleared using the 

510(k) process, identify the HCPCS codes, if applicable, that describe the 

predicate products listed in the 510(k) submission and explain why these codes do 

not adequately describe the item that is the subject of the HCPCS 

recommendation. In other words, if an item is listed as being substantially 

equivalent to another item(s) in an application for FDA marketing clearance, why 

is it not equivalent or comparable for coding purposes? 

c.) For drugs and biologicals only: In order for an application for a code for a 

drug/biological can be considered timely and complete: FDA approval 

documentation may be submitted after the code application, but no later than 

March 31, 2012, provided all other application materials are complete and 

submitted by the deadline of January 3, 2012, and provided the application for 

marketing approval has been submitted to the FDA by September 30, 2011. 

Applicants awaiting FDA clearance for drugs or biologicals at the January 3rd

submission deadline must submit with the application documentation evidencing 

submission for FDA approval, along with the date the application was submitted 

to the FDA. 

12A) When was the item/product marketed in the United States? 

Note For drugs and biologicals, the date of first sale is required. 

12B) For all items that are not drugs and not biologics, the applicant must submit 3 

months of marketing experience following the FDA approval date.

For the 3 months prior to submitting this coding recommendation, what is the total 

number of units sold in the U.S. and the total dollar amount in sales (Medicare, Medicaid 

and private insurance)? Do not estimate or provide projections - the information 

provided must represent actual volume of sales for the product for the period of time 

indicated. Note: For drugs and biologicals, information regarding the number of units 

sold is not required.

13. Identify the percent of use of the item across the following settings. For 

drugs/biologicals, provide the percentage of use for the setting in which this 

product is or would be administered.

 

Physician's Office: _______ 
Freestanding Ambulatory Care Clinics: _______ 

Patient's Home by patient: _______ 

Patient's Home by Health Care Provider: _______ 

Nursing Home/Skilled Nursing Facility: ________ 

Hospital Inpatient Facilities: ________ 

Hospital Outpatient Facility: ________ 

Other- (identify): _________

TOTAL VOLUME OF USE ACROSS ALL SETTINGS SHOULD EQUAL 100%

14. What is the Manufacturer’s Suggested Retail Price (MSRP) or list price of the item? 

This question must be answered for all items, except drugs/biologicals. 

HCPCS Coding Recommendation submitted by: 

* Please provide a complete mailing address and direct dial phone number. We use this 

information to contact applicants regarding upcoming meetings, questions regarding 

applications, and to make notifications of the status of applications.

Name: 

Name of Corporation/Organization: 

Mailing Address (street): 

City, State, Zip

Telephone Number and extension:

FAX Number: 

E-Mail Address: 

I attest that the information provided in this HCPCS coding recommendation is accurate 

and correct to the best of my knowledge. 

____________________________ _________________________Date:_____________ 

Signature of Applicant

Is applicant the manufacturer? Y/N If not, the manufacturer must sign the following 

attestation:

I attest that the information describing the product is accurate. 

____________________________ _________________________Date:_____________ 

Signature of Manufacturer 
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complete this information collection is estimated to average 11 hours per response, 

including the time to review instructions, search existing data resources, gather the data 

needed, and complete and review the information collection. If you have comments 

concerning the accuracy of the time estimate(s) or suggestions for improving this form, 

please write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, 

Mail Stop C4-26-05, Baltimore, Maryland 21244-1850.