Form CMS-10224 HCPCS LEVEL II CODE MODIFICATION REQUEST PROCESS

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 40page 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.hhs.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 [email protected]/medicare/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.hhs.gov/medhcpcsgeninfo ; 2)
submit an inquiry to [email protected]; 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 2010 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.
CMS needs this information in order to identify categories of new durable medical
equipment subject to the procedures established in accordance with the mandate of
section 531(b) of the Medicare, Medicaid and SCHIP Benefits Improvement and
Protection Act of 2000 (BIPA 2000), Public Law 106-554, for obtaining public
consultation on preliminary coding and payment determinations for these items. This
information is readily available from the manufacturers of these items and other
individuals submitting requests for changes to the HCPCS.
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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please write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer,
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