CMS-10224 CMS Response to Comments

eMS received a total of 3 comments in reaction to the HepeS information collection
posted in the December 10,2010 Federal Register. eMS received 1 comment regarding
the durability of products (question #4), FDA 510K requirement (question #11), and
estimated time burden. The other 2 comments were suggestions for an electronic
application process.
Responses to Comments
Question 4
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.
Comment
eMS received 1 comment that there has been limited direction on what is required for a
product to be considered "durable" under the Medicare program. The commenter
suggested that eMS avoid any changes until the terms used in expanded question 4 are
defined with specificity.
Response
The original text of item 4 on the 2011 HepeS application requests the applicant to
explain if the item is durable and elaborate on how the item can withstand repeated use ..
We are not proposing to remove or revise the existing, general question about whether an
item is durable and can withstand repeated use because it is relevant in determining
whether there is a Medicare program need for a change to the HepeS. The comments
indicate that there is limited direction on what is required of a product to be considered
durable. We are grateful to receive these comments because they underscore the need to
add secondary questions related to durability of items coded under the HepeS. Durable
medical equipment is one of the main categories of Medicare covered items that are
classified under the HepeS, and therefore, information regarding durability of items
classified under the HepeS is critical in determining whether a change in the HepeS is
needed.

Information in response to the proposed, additional questions under item 4 on the 2011
HepeS application is needed in order to support an applicant's claim that an item is
durable. The information obtained from the answers to the secondary questions would
include factual and readily available data about the product specifications and warranty
which should remain consistent regardless of the criteria used by eMS to classify items
as durable or nondurable. This information is necessary in determining whether there is a
program operating need to establish a new HepeS code or make coding changes for
different categories of items. In most cases, applications for changes to the HepeS that
are related to equipment or supplies are submitted from manufacturers or on behalf of
manufacturers of the equipment or supplies. We therefore believe that the burden for
obtaining this additional information is insignificant since manufacturers of equipment or
supplies are already very familiar with the equipment or supplies that they manufacturer.

Question #11
lla.) 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 51O(k) summary for those items
that are approved using the 510(k) process. Also, if an item is cleared using the
51O(k)process, identify the HepeS codes, if applicable, that describe the
predicate products listed in the 51O(k) submission and explain why these codes do
not adequately describe the item that is the subject of the HepeS
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?
Comment
eMS received 1 comment that question 11 has been expanded in a way that creates an
unreasonable expectation that the applicant undertake a burdensome search of how
predicate devices have been treated. The commenter suggested the deletion of the
expanded question.

Response
The revision of question 11 incorporates part of the answers provided to questions 7A
(Identify similar products and their manufacturers.) and 8e (Explain why existing code
categories are inadequate to describe the item.). As such, this is not a new requirement
and it should not create any undue burden to applicants. In fact, manufacturers that
request clearance under the 510(k) process must list predicate products in their 510(k)
summary when submitting their request to the FDA for marketing clearance. What is
new here is that eMS is requesting the applicant to provide an explanation as to why
items classified as equivalent by the FDA should not be identified in the same coding
category.

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