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Centers for Medicare & Medicaid Services (CMS)

Healthcare Common Procedure Coding System (HCPCS)


Public Meeting Summary Report
Durable Medical Equipment (DME)
Thursday, May 3, 2007

Introduction and Overview

Approximately 70 people attended. The agenda included 16 items.

Joel Kaiser of CMM presented an educational overview of the methods used for setting
the payment amount for items, and when the different methods are used. The overview
was also provided as a written attachment to the agenda and is also attached to this
summary. For additional information, the DME payment rules are located at Section
1834 (a) of the Social Security Act. The Medicare fee schedule for DME, Prosthetics,
Orthotics and Supplies, and background information, can be accessed and downloaded
free of charge at: www.cms.hhs.gov/feeschedulegeninfo.

Cindy Hake provided an overview of the HCPCS public meeting process as it relates to
the overall HCPCS coding process.

Prior to the Public Meetings, the CMS HCPCS workgroup meets to review all HCPCS
code applications, and to make preliminary coding recommendations. CMS also makes
preliminary recommendations regarding the applicable Medicare payment category and
methodology that will be used to set a payment amount for the items on the agenda. The
preliminary coding and payment recommendations are posted on the HCPCS website at:
www.cms.hhs.gov/medhcpcsgeninfo, as part of the HCPCS public meeting agendas.

Following the public meetings, the CMS HCPCS workgroup reconvenes, and considers
all the input provided at the Public Meetings regarding its preliminary coding
recommendations. CMS also reconsiders its Medicare payment recommendations. The
CMS maintains the permanent HCPCS level II codes, and reserves final decision making
authority concerning requests for permanent HCPCS codes. Final decisions regarding
Medicare payment are made by CMS and must comply with the Statute and Regulations.
Payment determinations for non-Medicare insurers, (e.g., state Medicaid Agencies or
Private Insurers) are made by the individual state or insurer.

Public Meetings are not CMS HCPCS workgroup meetings. Final decisions are not made
at the public meetings. All requestors will be notified in writing, in November, of the
final decision regarding the HCPCS code request(s) they submitted.

The process for developing agendas and speaker lists for the public meetings, and
Guidelines for Proceedings at CMS’ Public Meetings are posted on the official HCPCS
world wide web site at:
http://cms.hhs.gov/medhcpcsgeninfo/downloads/2007guidelines.pdf . The standard
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application format for requesting a modification to the HCPCS Level II Coding System,
along with instructions for completion and background information regarding the HCPCS
Level II coding process is available at:
http://cms.hhs.gov/medhcpcsgeninfo/downloads/2008_alpha.pdf. A decision tree,
outlining CMS’ decision-making criteria is also available at:
http://cms.hhs.gov/medhcpcsgeninfo/downloads/decisiontree.pdf.
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Centers for Medicare & Medicaid Services (CMS) Healthcare Common Procedure
Coding System (HCPCS) Public Meeting Agenda
For Durable Medical Equipment (DME)
Thursday, May 3, 2007, 9:00 a.m. – 5:00 p.m.
CMS Auditorium
7500 Security Boulevard
Baltimore (Woodlawn), Maryland 21244-1850

8:15 a.m. Arrival and sign-in

9:00 a.m. Welcome


Background and purpose of meeting
Meeting Format and Ground Rules

For each agenda item, a written overview of the request and CMS’s preliminary
coding decision is provided. An overview of Medicare pricing/payment,
methodology is also attached to this agenda. Preliminary decisions are not final or
binding upon any payer, and are subject to change. Meeting participants will hear
presentations about the agenda item from the registered primary speaker and other
speakers (if any). Presentations will be followed by an opportunity for questions
regarding that particular agenda item. The public meetings provide an opportunity
for the general public to provide additional input related to requests to modify the
HCPCS code set. Final decisions are not made at the public meetings. Applicants
will be notified of final decisions in November.

The agenda includes a summary of each HCPCS code application on the agenda.
The information provided in each summary reflects claims made by the applicant
and should not be construed as a statement of fact or an endorsement by the federal
government.

AGENDA ITEM #1
Attachment #07.63
Request to discontinue code E2101 BLOOD GLUCOSE MONITOR WITH
INTEGRATED LANCING/BLOOD SAMPLE.

AGENDA ITEM #2
Attachment #07.09
Request to establish a code to identify a device for treating Otitis Media with Effusion,
Aerotitis/Barotitis and Eustachian Tube Dysfunction, trade name: EarPopper®.
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AGENDA ITEM #3
Attachment #07.96
Request to establish a new code to identify a nasal cushion, pillow-style integrated
ventilation system, trade name: A.) ComfortLite™ 2 Pillows Cushion, B.)
ComfortLite™ 2 Direct Seal™ Cushion, and C.) ComfortLite™ Direct Seal™ Cushion.

AGENDA ITEM #4
Attachment #07.98
Request to establish a new code to identify a combination oral/nasal mask, trade name:
Hybrid Universal Interface.

AGENDA ITEM #5
Attachment #07.33A-G
Request to establish (7) codes to identify the WalkAide® External Functional
Neuromuscular Stimulator and replacement parts.

AGENDA ITEM #6
Attachment #07.36
Request to establish 3 new codes to identify segmental pneumatic appliances for the
trunk or chest, trade name: Flexitouch® Chest Garment, Flexitouch® Trunk Garment –
Lower Extremity, and Flexitouch® Trunk Garment – Upper Extremity.

AGENDA ITEM #7
Attachment #07.113
Request to establish 2 new codes to identify canes, trade names: Pilot Rolling Cane and
Pilot Step Platform.

AGENDA ITEM #8
Attachment # 07.52
Request to establish a code to identify a powered breast pump, trade name: Medela®
Symphony® Breastpump and Medela® Symphony® Breastpump Plus.

AGENDA ITEM #9
Attachment #07.34
Request to establish a code to identify an integrated wheelchair handrim assembly, brand
name: Natural-Fit™.

AGENDA ITEM #10


Attachment #07.85
Request to establish a code to identify a 2-gear manual wheelchair drive, trade name:
MAGICWHEELS™.

AGENDA ITEM #11


Attachment #07.76
Request to establish a new code to identify an automatic safety-lock braking system,
trade name: Jerry-Lock Brake System.
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AGENDA ITEM #12


Attachment #07.92
Request to establish a code to identify wheelchair disc brake and lock system with quick
release hub, Trade name: Wheelchair Disc Brakes.

AGENDA ITEM #13


Attachment #07.107
Request to establish a new code to identify a for long cycle life, safe, environmentally
friendly battery technology for powered mobility power chairs and power operated
vehicles, trade name: Envirofriendly™ Battery LifePO4.

AGENDA ITEM #14


Attachment #07.35
Request to establish a code to identify a portable knee extension device, Brand name:
Elite Seat® Portable Knee Extension Device

AGENDA ITEM #15


Attachment #07.67
Request to establish a code for a patient activated, serial stretch knee/ankle machine,
trade name: Knee/Ankle Flexionater.

Attachment #07.103
Request to establish a code for a patient actuated serial stretch shoulder machine, trade
name: Shoulder Flexionater.

Attachment #07.104
Request to establish a code for a patient actuated serial stretch knee extension device,
trade name: Knee Extensionater II.

Attachment #07.105
Request to establish a code for a patient actuated serial stretch MPJ (Metatarsophalangeal
Joint) Extension/Flexion device, trade name: MPJ Extensionater.

Attachment #07.106
Request to establish a code for a patient actuated serial stretch elbow extension/flexion
device, trade name: Elbow Extensionater.

AGENDA ITEM #16


Attachment # 07.134
Request to establish a code for a cervical support brace, trade name: Seattle Pneu-Trac
Traction Collar.
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HCPCS Public Meeting Agenda Item #1


May 3, 2007

Attachment: #07.63

Topic/Issue:
Request to discontinue code E2101 BLOOD GLUCOSE MONITOR WITH
INTEGRATED LANCING/BLOOD SAMPLE.

Background/Discussion:
According to the requestor, code E2101 was created and was used only to report the
mediSense Sof-Tact blood glucose monitor with integrated lancing and blood sample
application. Manufacturing and marketing of the Sof-Tact device was discontinued
effective June 2004. Abbott is not aware of any other products that fit into this code.
According to the requester, since there is no products currently available using code
E2101, there is no national program operating need to maintain the code. Maintenance of
the code causes confusion among suppliers and providers. Moreover, retaining the code
presents the possibility of inadvertently selecting an inappropriate code with a higher
Medicare fee schedule amount, which would lead to unnecessarily high Medicare
reimbursement and beneficiary copayment levels. Therefore, code E2101 should be
deleted.

CMS HCPCS Workgroup Preliminary Decision:


Keep existing code E2101 BLOOD GLUCOSE MONITOR WITH INTEGRATED
LANCING/BLOOD SAMPLE. Medicare is still receiving claims. There may be other
products on the market or potential new market entrants.

Medicare Payment:
The fee schedule and payment rules associated with existing code apply to this product.
Pricing =32

Summary of Primary Speaker Comments at the Public Meeting:


The primary speaker disagreed with CMS’ preliminary decision to keep code E2101.
The speaker claimed that the manufacturer has discontinued the device for which the
code was originally created, and that there are no products on the market that fit into this
code category. The speaker also claimed that keeping the code for potential new market
entrants is an insufficient reason to keep the code, and that the existing code encourages
inaccurate billing, and could potentially restrict access to new market entrants.
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HCPCS Public Meeting Agenda Item #2


May 3, 2007

Attachment: #07.09

Topic/Issue:
Request to establish a code to identify a device for treating Otitis Media with Effusion,
Aerotitis/Barotitis and Eustachian Tube Dysfunction, trade name: EarPopper®.

Background/Discussion:
According to the requester, the EarPopper is a safe, simple non-surgical, non-drug related
prescription device for treating common conditions such as Otitis Media with Effusion,
Aerotitis/Barotitis caused by rapid elevation changes, and Eustachian Tube Dysfunction.
EarPopper is a hand-held, battery operated device that delivers a constant, controlled
stream of air pressure and flow into the nasal passages diverting air up the Eustachian
tube when the patient swallows. This action clears and ventilates the middle ear and
immediately restores hearing. Current treatments for middle ear fluid or Otitis Media
with Effusion (OME) include “watchful waiting” and antibiotic prescriptions. Persistent
OME is often treated with surgical implantation of ear ventilation tubes. According to
the requester, both antibiotics and surgery have proven problematic and often
unsuccessful. Use of the EarPopper device could negate the need for antibiotic or
surgical treatments in patients suffering from ear related issues.

CMS HCPCS Workgroup Preliminary Decision:


No insurer (i.e., Medicare, Medicaid, or Private Insurance Sector), identified a national
program operating need to establish a code to identify this product. For coding guidance,
contact the insurer in whose jurisdiction a claim would be filed. For private insurers,
contact the individual private insurance contractor. For Medicaid, contact the Medicaid
Agency in the state in which a claim would be filed. For Medicare, contact the Medicare
contractor.

Medicare Payment:
Based on guidance contained in an informal benefit category determination, we believe
that there would be no Medicare payment for this item.

Summary of Primary Speaker Comments at the Public Meeting:


There was no primary speaker for this item.
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HCPCS Public Meeting Agenda Item #3


May 3, 2007

Attachment: #07.96

Topic/Issue:
Request to establish a new code to identify a nasal cushion, pillow-style integrated
ventilation system, trade name: A.) ComfortLite™ 2 Pillows Cushion, B.)
ComfortLite™ 2 Direct Seal™ Cushion, and C.) ComfortLite™ Direct Seal™ Cushion.
Suggested Language:
“Nasal Cushion, Pillows-Style with Integrated Ventilation System, Each”

Background/Discussion:
According to the requestor, the ComfortLite™ pillow-style cushions are integrated, one-
piece cushions with pliable, nasal pillows that contact the patient in or under the nasal
openings. A defining characteristic is the integration of a ventilation system within the
cushion itself. Ventilation is necessary to prevent the build-up of deadly CO2 during
CPAP or RAD therapy. Integrating the ventilation openings into the cushion optimizes
the rapid removal of CO2 , thereby optimizing CPAP and RAD therapy.

Within the current code for nasal pillows (A7033 “Pillow for use on nasal cannula type
interface, replacement only, pair”), there is a wide range of products that differ in both
structure and function from the Respironics’ pillow-style cushions with integrated
ventilation systems, including two-piece “cap-style” pillows and one-piece products that
lack ventilation within the cushion itself. The requestor claims that “if the more
sophisticated pillow-style cushions are lumped within the same code as less sophisticated
“pillows”, there is a significant risk that patients may not have access to them in the
future. A7033 was established originally for simpler cap-style pillows, which are readily
distinguishable on the basis of structure, function, and cost.”

CMS HCPCS Workgroup Preliminary Decision:


Existing code A7033 PILLOW FOR USE ON NASAL CANNULA TYPE INTERFACE,
REPLACEMENT ONLY, PAIR adequately describes a category of items similar to the
item that is the subject of this request. Inquiries regarding the fee associated with this
code are not within the jurisdiction of the HCPCS workgroup and should be submitted to
the insurer in whose jurisdiction a claim would be filed.

Medicare Payment:
The fee schedule and payment rules associated with existing code apply to this product.
Pricing =32

Summary of Primary Speaker Comments at the Public Meeting:


The primary speaker disagreed with CMS’ preliminary decision. The speaker claimed
that these newer products are not described by code A7033 and reiterated the request to
establish new codes for ComfortLite products. The speaker proposes reassignment of
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products across codes A7032 and A7033 based on the exhalation port, as opposed to fit
in-or under the nose.
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HCPCS Public Meeting Agenda Item #4


May 3, 2007

Attachment: #07.98

Topic/Issue:
Request to establish a new code to identify a combination oral/nasal mask, trade name:
Hybrid Universal Interface. Suggested Language: “Combination oral/nasal mask, used
with continuous positive airway pressure device, each”

Background/Discussion:
According to the requestor, the Hybrid is used with continuous positive airway (CPAP)
devices to treat sleep apnea and other respiratory disorders. The Hybrid unites the
comfort and proven reliability of nasal pillows and the efficiency of a dual airway mask.
It serves as a nasal interface, an oral interface, and a combination of both. It is connected
to tubing and a swivel connector and then to the positive air pressure machine. In
addition to the headgear, the Hybrid consists of three main components: a polycarbonate
shell, a silicone cushion to be placed over the lower face and mouth, and a pair of nasal
pillows that deliver positive air pressure to the nasal cavities. This design feature of
having nothing on the bridge of the nose or forehead reduces facial sores and allows
patients also to wear glasses. According to the requester, there are fewer air leaks with
the Hybrid’s design, significantly alleviating the problem of dry eyes caused by other full
face masks. The Hybrid’s design has virtually eliminated air blowing into the eyes.
Further, patients experience less noise and leaks with the Hybrid, creating lower
incidence of patients awakening during the night. Because the oral cushion and the nasal
pillows are separate components, the Hybrid offers a patient nine different size
combinations instead of the three size options of other full face masks. The nasal pillows
come in small, medium, and large, as does the oral cushion. Because of these added
design features, the Hybrid is more expensive to manufacture than other full face masks
currently on the market.

CMS HCPCS Workgroup Preliminary Decision:


Use newly established codes:
K0553 COMBINATION ORAL/NASAL MASK, USED WITH CONTINUOUS
POSITIVE AIRWAY PRESSURE DEVICE, EACH
K0554 ORAL CUSHION FOR COMBINATION ORAL/NASAL MASK,
REPLACEMENT ONLY, EACH
K0555 NASAL PILLOWS FOR COMBINATION ORAL/NASAL MASK,
REPLACEMENT ONLY, PAIR

Medicare Payment:
Based on guidance contained in an informal benefit category determination, we believe
that the items would be paid in accordance with the payment rules that apply to
Inexpensive and Other Routinely Purchased Items.
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Summary of Primary Speaker Comments at the Public Meeting:


The primary speaker agreed with CMS’ preliminary decision to establish codes K0553,
K0554, and K0555. The speaker supported continued use of these newly established
temporary codes.
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HCPCS Public Meeting Agenda Item #5


May 3, 2007

Attachment: #07.33 A-G

Topic/Issue:
Request to establish (7) codes for the WalkAide® External Functional Neuromuscular
Stimulator, and replacement parts, Brand name: The WalkAide® System: A)
WalkAide® System Patient Kit (includes patient evaluation, fitting, instruction,
supervision, training and follow-up for 90 days), B) WalkAide® Control Unit, C)
WalkAide® Electrode Lead Cable, D) WalkAide® System Cuff, E) WalkAide®
Electrodes (Pkg. 4), F) WalkAide® System Electrodes (Case of 10 packages of 4), and
G) WalkAide® System Patient Foot Sensor

Background/Discussion:
According to the requester, the WalkAide System is a combination of Programmable FES
(Functional Electrical Stimulation) and a unique patented tilt sensor process which
analyzes leg movement using embedded software. The WalkAide sends electrical signals
to a common peroneal nerve which activates the muscles in the lower extremity to raise
the foot at the appropriate time during the gait cycle. The WalkAide System is a small
and discreet device designed for repetitive daily use through placement directly on the leg
under any type of clothing. The system has undergone a comprehensive verification and
validation process according to the USA FDA and international standards. The testing
includes drop and splash testing, electromagnetic compatibility testing, and performance
testing to ensure that the WalkAide is durable and can withstand repeated use. The
WalkAide System utilizes an optimized Tilt Sensor to trigger stimulation, eliminating the
need for external wires or conscious input form the wearer.

CMS HCPCS Workgroup Preliminary Decision:


Existing code E1399 “DURABLE MEDICAL EQUIPMENT, MISCELLANEOUS” is
available for assignment by insurers (if they deem appropriate) to identify the WalkAide
system on including all components on initial issue. Existing code A9999
“MISCELLANEOUS DME SUPPLY OR ACCESSORY, NOT OTHERWISE
SPECIFIED” is available for assignment by insurers (if they deem appropriate) to
identify the control unit, electrode lead cable, cuff, electrodes and foot sensor for
replacement only, after initial issue. Reported sales volume was insufficient to support
the establishment of a new national code. In accordance with HCPCS coding criteria as
published on CMS’ HCPCS website, there must be sufficient claims activity or volume,
as evidenced by 3 months of marketing activity, so that the adding of a new or modified
code enhances the efficiency of the system and justifies the administrative burden of
adding or modifying a code. CMS will be happy to consider an application in a later
coding cycle if sales volume increases substantially.

Medicare Payment:
The fee schedule and payment rules associated with existing code apply to this product.
Pricing = 46
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Summary of Primary Speaker Comments at the Public Meeting:


The primary speaker disagreed with CMS’ preliminary decision. The speaker claimed
that there has been a significant increase in sales since the application submission date.
The speaker also claimed that the FDA considers the Walk Aide a “neuroprosthetic”; and
that Walk Aide replaces damaged Central Nervous System mechanism that decides when
to elevate the foot during the gait cycle.
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HCPCS Public Meeting Agenda Item #6


May 3, 2007

Attachment: #07.36

Topic/Issue:
Request to establish 3 new codes for segmental pneumatic appliances for the trunk or
chest, trade name: Flexitouch® Chest Garment, Flexitouch® Trunk Garment – Lower
Extremity, and Flexitouch® Trunk Garment – Upper Extremity. Requester suggested
language: (1)“Segmental Pneumatic Appliance for use with Pneumatic Compressor,
Chest Appliance”; (2)“Segmental Pneumatic Appliance for use with Pneumatic
Compressor, Trunk Appliance – Upper Extremity” and (3) “Segmental Pneumatic
Appliance for use with Pneumatic Compressor, Trunk Appliance – Lower Extremity”

Background/Discussion:
According to the requester, the Flexitouch Lymphedema System, is a segmented
pneumatic compression system with calibrated gradient pressure, consists of a controller
that attaches to segmental appliances which cover the limb, trunk and chest. The
Flexitouch chest and trunk appliances are multi-layer inflatable appliances consisting of a
proprietary composite of materials designed to provide a gentle stretch against the skin to
stimulate the superficial lymphatics. They are adjustable to each individual patient using
hook and loop fasteners. The appliances are attached by hoses to the Flexitouch
pneumatic controller. Appliance chambers inflate and deflate in a sequential pattern
based on well-established manual lymphatic drainage protocol; this sequential pattern
together with the gentle stretch of the skin is known to further stimulate the lymphatics.
The shape of each chamber is curved so as to be approximately perpendicular to those
lymphatic vessels in the chest or trunk to promote routing of the fluid in the desired
direction. The therapeutic result is lymph vascular transport (i.e. movement of fluid).

CMS HCPCS Workgroup Preliminary Decision:


No insurer (i.e., Medicare, Medicaid, or Private Insurance Sector), identified a program
operating need to establish a code to identify these pneumatic compression garments.
Your reported sales volume was insufficient to support the establishment of a new
national code. In accordance with HCPCS coding criteria as published on CMS’ HCPCS
website, there must be sufficient claims activity or volume, as evidenced by 3 months of
marketing activity, so that the adding of a new or modified code enhances the efficiency
of the system and justifies the administrative burden of adding or modifying a code.
CMS will be happy to consider an application in a later coding cycle if sales volume
increases substantially. Existing code E1399 DURABLE MEDICAL EQUIPMENT,
MISCELLANEOUS is available for assignment by insurers, as they deem appropriate.
For coding guidance, contact the insurer in whose jurisdiction a claim would be filed.
For private insurers, contact the individual private insurance contractor. For Medicaid,
contact the Medicaid Agency in the state in which a claim would be filed.
15

Medicare Payment:
The fee schedule and payment rules associated with existing code apply to this product.
Pricing = 46

Summary of Primary Speaker Comments at the Public Meeting:


The primary speaker disagreed with CMS’ preliminary decision. The speaker questioned
the 3% volume threshold and asked for an exception because the requested code is for an
accessory to established therapy. The speaker would like the workgroup to view this
request as an extension to existing codes.
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HCPCS Public Meeting Agenda Item #7


May 3, 2007

Attachment: #07.113

Topic/Issue:
Request to establish 2 new codes for canes, trade names: Pilot Rolling Cane and Pilot
Step Platform. Requester Suggested Language: (1) “Cane, 4 wheels, braking
mechanism, adjustable, each”; and (2) “Platform attachment, quad cane, each”

Background/Discussion:
According to the requestor, the Pilot Rolling Cane provides the support of a quad cane
with a unique wheeled base, which gives constant ground contact. This allows the
patient’s weight to be continuously applied, improving gait cycle. The rolling cane
prevents the patient from having to lift the cane with each step, requiring less
coordination and cognitive energy while walking. For some patients, the use of the Pilot
rolling cane can delay the move to a full walker as they deteriorate. Rolling cane has a
built-in brake in the handle for additional control on inclines and declines. It also has an
additional set of lower handles, which assists the user in rising from seats and toilets
using less arm strength; and a built-in hook, which allows the user to hook the cane onto
a shopping cart, etc. The rolling cane is indicated for patients with impaired ambulation.

According to the requester, the Pilot platform is an add-on for a quad cane that provides
extra stability. The unique flip-up platform allows patients with limited range of motion
in their hips and/or knees to step up on stairs, curbs and provide assistance to step into a
car. With the push of a button, the hinged platform can be flipped open to allow users to
safely step half the distance of conventional steps and curbs, requiring less than half the
energy of stepping a whole stair height. The Step Platform should be considered as an
accessory to the quad cane.

CMS HCPCS Workgroup Preliminary Decision:


Existing code E0105 CANE, QUAD OR THREE PRONG, INCLUDES CANES OF
ALL MATERIALS, ADJUSTABLE OR FIXED, WITH TIPS is available for assignment
by insurers to identify the Pilot Rolling Cane as they deem appropriate. No insurer (i.e.,
Medicare, Medicaid, or Private Insurance Sector), identified a national program operating
need to establish a code to identify the step up accessory. For coding guidance, contact
the insurer in whose jurisdiction a claim would be filed. For private insurers, contact the
individual private insurance contractor. For Medicaid, contact the Medicaid Agency in
the state in which a claim would be filed. For Medicare, contact the Medicare contractor.

Medicare Payment:
Fee schedule and payment rules associated with existing code apply to this product.
Pricing = 32
17

Summary of Primary Speaker Comments at the Public Meeting:


The primary speaker disagreed with CMS’ preliminary decision. The speaker stated that
the Rolling Cane is not a quad cane. The speaker also claimed that codes for wheeled
walkers set a precedent for the establishment of a code to identify wheeled canes. The
speaker stated that this product is different and superior because the “rehabilitation
process is significantly reduced as a result of the use of the Rolling Cane”.
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HCPCS Public Meeting Agenda Item #8


May 3, 2007

Attachment: #07.52

Topic/Issue:
Request to establish a code to identify a powered breast pump, trade name: Medela®
Symphony® Breastpump and Medela® Symphony® Breastpump Plus. Requester
Suggested Language: “Breastpump, heavy duty, hospital grade, membrane operated,
programmable automatic multi-phase vacuum”.

Background/Discussion:
According to the requestor, the Medela® Symphony® Breastpump and Medela®
Symphony® Breastpump Plus provide the means to express breast milk using multiple
different milk extraction patterns. The only difference in the two Symphony model
pumps is that the Plus is equipped with two internal rechargeable batteries. The pumps
provide the ability to change the pumping pattern by changing the programming that
controls the vacuum level and cycles/minute, and can vary these functions throughout the
pumping session. The programming is controlled by a microchip card that can be
changed every time a different pumping pattern is desired. The Symphony is capable of
providing vacuum levels from 0 to 250 mm Hg, with cycling rates up to 130 cycles per
minute. The programmability provides the potential for the healthcare professional to
prescribe the pattern best suited to each patient’s medical need. The pump will maintain
milk supply in mothers who have delivered their baby prematurely, when the baby is
unable to nurse normally, or during long periods of separation between the mother and
baby because it removes as much milk as a breastfed baby. E0604 “Breast pump, heavy
duty, hospital grade, piston operated, pulsatile vacuum suction/release cycles, vacuum
regulator, supplies, transformer, electric (AC and/or DC)” has been used to describe this
product. According to the requestor, this code is not adequate to describe this product
because 1) pulsatile vacuum only describes a constant vacuum setting and cycles/minute,
(as opposed to Symphony’s multiphase capability); 2) the Symphony models are not
piston operated pumps; they are membrane operated pumps; and 3) the existing fee
schedule for breast pumps is too low to cover the costs of this new generation of higher
technology breast pumps.

CMS HCPCS Workgroup Preliminary Decision:


Revise code E0604 which currently reads: BREAST PUMP, HEAVY DUTY,
HOSPITAL GRADE, PISTON OPERATED, PULSATILE VACUUM
SUCTION/RELEASE CYCLES, VACUUM REGULATOR, SUPPLIES,
TRANSFORMER, ELECTRIC (AC AND/OR DC), to instead read: BREAST PUMP,
HEAVY DUTY, ELECTRIC (AC AND/OR DC), ANY TYPE
19

Medicare Payment:
Fee schedule and payment rules associated with existing code apply to this product.
Pricing = 00

Summary of Primary Speaker Comments at the Public Meeting:


The primary speaker accepted CMS’ decision not to establish a code, but disagreed with
the proposed revision of code E0604, and instead suggested the following language:
“Breast pump, hospital grade multi-use pump, suction/release cycle, supplies, electric
(AC and/or DC)”. According to the speaker, CMS’ proposed language using the words
“heavy duty” permits blurring of the distinction between products coded at E0603 and
E0604, and sets up the possibility of provision of E0603 categorized pumps in non-
hospital settings to mothers who need E0604 categorized pumps. The speaker also
claimed that this breast pump is a “medical necessity” for “pump dependent mothers”.
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HCPCS Public Meeting Agenda Item #9


May 3, 2007

Attachment: #07.34

Topic Issue:
Request to establish a code to identify an integrated wheelchair handrim assembly, brand
name: Natural-Fit™. Requester’s suggested language: “Manual wheelchair accessory,
integrated two-piece handrim system; contoured thumb slot and contoured oval and
multi-friction surfaces”.

Background/Discussion:
According to the requester, the Natural-Fit is ergonomically designed to relieve stress on
the hands and wrists during the repetitive strain of manual wheelchair propulsion, and to
reduce pain associated with Carpal Tunnel Syndrome (CTS). The intended patient
population is manual wheelchair users who report CTS-related pain in the hand and wrist.
This population requires a non-invasive option (in contrast to surgery or prescription of a
power wheelchair) for treating CTS-related pain. According to the requester, existing
code E2205 “MANUAL WHEELCHAIR ACCESSORY, HANDRIM WITHOUT
PROJECTIONS, ANY TYPE, REPLACEMENT”, describes a manual wheelchair
accessory used for mobility because of lower-extremity impairment and that do not treat
pain associated with CTS (an upper-extremity impairment). Instead, the pinch grip
required by the small tube of “E2205 handrims” exacerbates CTS-related pain. Thus, the
requester feels that the E2205 descriptor is overly broad and fails to recognize the
different functions that handrims serve for different sub-populations such as those
experiencing CTS. The applicant cites a 3-study paper published in 2006 and claims that
the studies “demonstrated that use of the Natural Fit results in improved clinical
outcomes related to CTS”, specifically: 1) “reduced pain in hands and wrists”; and 2)
“improved function across a variety of activities of daily living”. The applicant also
expressed concern that assignment of the Natural Fit handrim to existing code E2205
ignores “an effective non-invasive treatment of CTS” and denies access to Medicare
beneficiaries because the Natural Fit cannot be produced and sold under the Medicare
“fee limits” for E2205.

CMS HCPCS Workgroup Preliminary Decision:


Existing code E2205 MANUAL WHEELCHAIR ACCESSORY, HANDRIM
WITHOUT PROJECTIONS, ANY TYPE, REPLACEMENT ONLY, EACH adequately
describes a category of items with the same or similar function. Clinical information
provided by the applicant does not include peer-reviewed evidence that would support a
claim of superior clinical outcome when using this device, as compared with other
devices categorized at E2205. No insurer identified a national program operating need to
differentiate this item based on a contoured thumb slot and contoured oval and mult-
friction surfaces.
21

Medicare Payment:
Fee schedule and payment rules associated with existing code apply to this product.
Pricing = 32

Summary of Primary Speaker Comments at the Public Meeting:


The primary speaker disagreed with CMS’ preliminary decision. The speaker stated that
Natural-Fit is a “unique treatment option for individuals with carpal tunnel syndrome”.
The speaker claimed that the application includes substantial clinical evidence including
direct test, supporting superior clinical outcomes, (supports ergonomics in the treatment
of pain and injury). The speaker specifically cited the Koontz, Yang, Boninger, Kanaly,
Cooper, Boninger, Dieruf and Ewer study: “Investigation of the Performance of an
Ergonomic Handrim as a Pain-Relieving Intervention for Manual Wheelchair Users”,
Assistive Technology, Vol. 18, Nov 2, 2006. The speaker requested that the workgroup
consider the added value of converging evidence.
22

HCPCS Public Meeting Agenda Item #10


May 3, 2007

Attachment: #07.85

Topic/Issue:
Request to establish a code to identify a 2-gear manual wheelchair drive, trade name:
MAGICWHEELS™. Requester Suggested Language: “Manual wheelchair accessory,
push-rim driven 2-gear reduction drive wheel with automatic hill hold and override,
pair”.

Background/Discussion:
According to the requester, the MAGICWHEELS™ technology is the hypocycloidal
reduction drive-a patented gear mechanism which creates unique loading and friction
characteristics. It provides a user with additional assistance by providing “leverage”
through gearing. The two-gear wheels offer two power ratios – 1:1 (no help, no extra
friction) and 2:1, providing 100 percent more hill-climbing force with automatic hill
holding. In the 2:1 ratio 50 percent less effort (force on the push-rim) is required to stop
the wheelchair. They’ll fit on any wheelchair, including those that don’t have quick
release wheels; will add approximately 10 pounds per chair, and won’t normally affect
width or folding.

The 2-gear wheels were developed to assist a wheelchair user with varying forms of
mobility disorders ranging from arthritis, multiple sclerosis, and muscular dystrophy,
paraplegia, and quadriplegia/tetraplegia, and have been shown in an independent
university based clinical study to relieve or reduce “manual wheelchair syndrome”. This
syndrome, caused by propelling a manual wheelchair, consists mainly of repetitive stress
injuries such as rotator cuff and carpal tunnel syndrome which are common problems
among manual wheelchair users.

Third party payers (private health insurance, auto liability insurance, workman’s
compensation, Department of Vocational Rehab and private pay) are currently being
billed under codes K0108 – “wheelchair component or accessory, not otherwise
specified”

CMS HCPCS Workgroup Preliminary Decision:


No insurer (i.e., Medicare, Medicaid, or Private Insurance Sector), identified a national
program operating need to establish a code to identify this product. Reported sales
volume was insufficient to support the establishment of a new national code. In
accordance with HCPCS coding criteria as published on CMS’ HCPCS website, there
must be sufficient claims activity or volume, as evidenced by 3 months of marketing
activity, so that the adding of a new or modified code enhances the efficiency of the
system and justifies the administrative burden of adding or modifying a code. CMS will
be happy to consider an application in a later coding cycle if sales volume increases
substantially. Existing code K0108 WHEELCHAIR COMPONENT OR ACCESSORY,
NOT OTHERWISE SPECIFIED, is available for assignment by insurers as they deem
23

appropriate. For coding guidance, contact the insurer in whose jurisdiction a claim would
be filed. For private insurers, contact the individual private insurance contractor. For
Medicaid, contact the Medicaid Agency in the state in which a claim would be filed. For
Medicare, contact the Medicare contractor.

Medicare Payment:
Fee schedule and payment rules associated with existing code apply to this product.
Pricing = 46

Summary of Primary Speaker Comments at the Public Meeting:


The primary speaker disagreed with CMS’ preliminary decision. The primary speaker
stated that 23 engineering changes have been implemented, since the product was first
marketed, based on direct feedback from consumers, therapists, and providers. The
speaker also documented an increase in sales activity, since the application was
submitted.
24

HCPCS Public Meeting Agenda Item #11


May 3, 2007

Attachment: #07.76

Topic/Issue:
Request to establish a new code to identify an automatic safety-lock braking system,
trade name: Jerry-Lock Brake System. Requester suggested language: “Wheelchair
accessory, automatic safety brake system, each”

Background/Discussion:
According to the requester, the Jerry-Lock Brake System is an integrated safety lock
braking system that automatically engages the add-on brakes when the wheelchair user
attempts to exit the chair. This helps to prevent the chair from moving during transfers,
thus preventing falls and injuries. In contrast to anti-roll back devices described by
existing codes, the Jerry-Lock Brake System prevents the wheelchair from moving
backward and forward, functioning as a true brake and not simply a directional control
while propelling the chair up an incline. Currently there are no codes to describe any
form of auxiliary brakes.

The Jerry-Lock Brake System is a heavy duty brake system that is designed to last the life
of the wheelchair that it is mounted on. The system is designed to be mounted to a
standard wheelchair as an add-on accessory. The standard, factory installed brakes still
remain in place and operational, although not necessary for safe operation.

The accessory safety brake system is intended for use by individuals with cognitive
impairment that prevents them from safely using standard brake systems, or those who
cannot manually operate them due to limited mobility, dexterity or strength.

CMS HCPCS Workgroup Preliminary Decision:


No insurer (i.e., Medicare, Medicaid, or Private Insurance Sector), identified a national
program operating need to establish a code to identify this product. For coding guidance,
contact the insurer in whose jurisdiction a claim would be filed. For Private Insurance,
contact the individual private insurance contractor. For Medicaid, contact the Medicaid
Agency in the state in which a claim would be filed. For Medicare, contact the Medicare
contractor.

Medicare Payment:
Based on guidance contained in an informal benefit category determination, we believe
that there would be no Medicare payment for this item.

Summary of Primary Speaker Comments at the Public Meeting:


There was no primary speaker for this item.
25

HCPCS Public Meeting Agenda Item #12


May 3, 2007

Attachment: #07.92

Topic/Issue:
Request to establish a code to identify wheelchair disc brake and lock system with quick
release hub, Trade name: Wheelchair Disc Brakes.

Background/Discussion:
According to the requester, the Wheelchair Disc Brake and Lock System with Quick
Release Hub technology enable near effortless wheelchair braking, as well as a full lock,
for those who rely on a wheelchair for primary mobility. Disc brake systems require only
light pressure application of less than 1 lb. on a single lever to fully manage both braking
and locking functions. Forces exerted through wrist, elbow and shoulder during
repetitive tasks such as transfers and deceleration are thus greatly reduced. This product
is presently prescribed for patients with quadriplegia and paraplegia, to increase safety
and function, to reduce low back, wrist and shoulder pain, and eliminate repetitive
twisting and stabilizing motions needed to engage traditional wheel locks. Some
individuals, who would otherwise be limited to power mobility, would now be able to
perform safe, independent transfers, propulsion, and ramp/hill management from manual
wheelchairs. The brakes require only one (out of the way for transfers) lever for
operation, are easily engaged/disengaged (or set in increments of braking) to assist chair
stability on uneven flooring, and function without constant adjustment, regardless of tire
condition/pressure or wet conditions (bath/shower safety). The 2-piece hub is a critical
component of the system, enabling installation on most prescribed manual wheelchairs to
retain quick release/removal function of the wheel during chair storage/transportation.

CMS HCPCS Workgroup Preliminary Decision:


Existing code E2206 MANUAL WHEELCHAIR ACCESSORY, WHEEL LOCK
ASSEMBLY, COMPLETE, EACH adequately describes the item that is the subject of
your request. No insurer (i.e., Medicare, Medicaid, or the Private Insurance Sector),
identified a national program operating need to separately or uniquely code the features
of this product that may not be part of other wheel lock assemblies included in E2206.

Medicare Payment:
Fee schedule and payment rules associated with existing code apply to this product.
Pricing = 32

Summary of Primary Speaker Comments at the Public Meeting:


The primary speaker disagreed with CMS’ preliminary decision. The speaker claimed
that there is a difference in functionality, technology and clinical applications. The
speaker stated that although this product does lock, a new code is warranted because the
“primary function” of this product is to provide a braking system for manual wheelchairs
that helps to descend ramps, hills and driveways. The speaker refuted CMS’ preliminary
decision that insurers “don’t need a code” on the basis that this technology is so new that
26

insurers don’t know or understand it. The speaker also stated that a new code
classification system is needed to identify wheelchair braking systems and advanced
accessory systems for products that serve a dynamic function.
27

HCPCS Public Meeting Agenda Item #13


May 3, 2007

Attachment: #07.107

Topic/Issue:
Request to establish a new code to identify a for long cycle life, safe, environmentally
friendly battery technology for powered mobility power chairs and power operated
vehicles, trade name: Envirofriendly™ Battery LifePO4. Requester suggested language:
“Phosphate Based Lithium Iron Battery”

Background/Discussion:
According to the requestor, Envirofriendly Battery is the next generation in battery
technology, safe, cost effective, lightweight, and high energy. Envirofriendly is a
phosphate based lithium iron battery that is inherently safe and environmentally friendly.
Its active ingredient, LiFePO4 is a safe large format battery chemistry for lithium based
battery for use in power mobility devices and oxygen concentrators. Envirofriendly has a
charge-discharge cycle of 2000 cycles and average charge time is 2-4 hours. According
to the requester, Envirofriendly has many features and benefits including:
- virtually zero maintenance over the long life of the battery
- long life of battery eliminating annual cost of replacement
- lightweight, high performance, high energy
- outstanding charging cycles ability
- no battery memory effect
- no battery damage on full depth of discharge
- sleep mode
- no explosive hydrogen gassing
- environmentally friendly

CMS HCPCS Workgroup Preliminary Decision:


Establish the following code:
Exxxx POWER WHEELCHAIR ACCESSORY, LITHIUM IRON PHOSPHATE
BATTERY, EACH

Medicare Payment:
Based on guidance contained in an informal benefit category determination, we believe
that the items would be paid in accordance with the payment rules that apply to
Inexpensive and Other Routinely Purchased Items.

Summary of Primary Speaker Comments at the Public Meeting:


The primary speaker supported CMS’ preliminary decision and corresponding Medicare
payment determination.
28

HCPCS Public Meeting Agenda Item #14


May 3, 2007

Attachment: #07.35

Topic/Issue:
Request to establish a code to identify a portable knee extension device, Brand name:
Elite Seat® Portable Knee Extension Device

Background/Discussion:
According to the requester, LLC, the Elite Seat® is a passive, patient controlled static
progressive knee extension device that is used while in a supine position. The Elite
Seat® is intended for patients with indications such as an arthritic knee joint with a
flexion contracture, deconditioned knee with a flexion contracture, arthrofibrosis, total
knee arthroplasty, acute ACL injury, post-operative ACL rehabilitation, or similar
conditions resulting in a flexion contracture, or “bent” knee. Currently, there is no code
that encompasses all the key functions of the Elite Seat® as it applies to knee extension.

According to the requester, The Elite Seat is not well described by current HCPCS codes
for adjustable knee extension devices, for four important reasons:
(1) The Elite Seat is a “static” stretching device. The knee stretches toward full
extension by applying an equally distributed static force both above and below the knee.
(2) The patented design requires the patient to be in a supine position during use. Being
in a supine position is the only way to keep the hamstring relaxed and allow the knee to
reach extension equal to the unaffected knee.
(3) As extension is regained, the patient progressively applies greater levels of static
force to increase the devices propensity to stretch the knee using the patient-controlled
crank device.
(4) The Elite Seat provides a safe and effective way to passively stretch the knee into full
extension or symmetry between knees to correct a flexion contracture which effectively
increases extension and function and decreases pain.

CMS HCPCS Workgroup Preliminary Decision:


Revise code E1811 which currently reads: “BI-DIRECTIONAL STATIC
PROGRESSIVE STRETCH KNEE DEVICE WITH RANGE OF MOTION
ADJUSTMENT, INCLUDES CUFFS” to instead read: “STATIC PROGRESSIVE
STRETCH KNEE DEVICE, EXTENSION/FLEXION WITH OR WITHOUT RANGE
OF MOTION ADJUSTMENT, INCLUDES CUFFS”. Revised code E1811 adequately
describes the product that is the subject of this request.

Medicare Payment:
The fee schedule and payment rules associated with existing code apply to this product.
Pricing = 36
29

Summary of Primary Speaker Comments at the Public Meeting:


The primary speaker disagreed with CMS’ preliminary decision. The speaker claimed
that revised E1811, as proposed by CMS, is appropriate due to the unique design and
application of the technology as it operates by non-invasive means. The speaker
reiterated the request for a new code based on new evidence and clarification of
information, along with a more detailed product description. The speaker stated that key
differences in the product are:
1) it is designed for hyper-extension
2) is used while in a supine position
3) straps and cabling system allows evenly distributed static force to increase the
devices propensity to stretch the knee to hyper-extension
4) a quick-release button and auxiliary handle are included for patient comfort and
control.
30

HCPCS Public Meeting Agenda Item #15


May 3, 2007

Attachment: #07.67

Topic/Issue:
Request to establish a code for a patient activated, serial stretch knee/ankle machine,
trade name: Knee/Ankle Flexionater. Suggested Language: “Patient actuated serial
stretch knee/ankle machine, variable load/variable position, patient controlled, with
hydraulic pump.”

Background/Discussion:
According to the requestor, the Knee/Ankle Flexionater is used to treat patients with
arthrofibrosis or similar conditions that impair knee or ankle joint range of motion. It
facilitates and accelerates recovery from decreased range of motion of the knee and/or
ankle joints due to arthrofibrosis, a complication of injury or surgery where an excessive
scar tissue response leads to painful restriction of motion. It is fully patient controlled,
variable load/variable position medical equipment that utilizes a hydraulic pump and
quick-release mechanism that allows patients to perform stretching therapy sessions,
alternately stretching and relaxing the scar tissue and adhesions surrounding the affected
joints. This technique is referred to as the Patient Actuated Serial Stretch (PASS)
protocol, which is unique to the product line, and follows the well established principles
of Total End Range Time (TERT) for stretching soft tissues. The Knee/Ankle
Flexionater utilizes patient controlled, variable loading forces to stretch the scar tissue
gradually and increase joint range of motion over the course of therapy following the
TERT formula. E1810 “Dynamic adjustable knee extension/flexion device, includes soft
interface material”, E1812 “Dynamic knee, extension/flexion device with active
resistance control”, and E1399 “Durable Medical Equipment, Miscellaneous have been
used to describe this product; however, the requestor claims that the Knee/Ankle
Flexionater and the devices described by these codes are very different devices.

CMS HCPCS Workgroup Preliminary Decision:


Revise code E1811 which currently reads: “BI-DIRECTIONAL STATIC
PROGRESSIVE STRETCH KNEE DEVICE WITH RANGE OF MOTION
ADJUSTMENT, INCLUDES CUFFS” to instead read: “STATIC PROGRSSIVE
STRETCH KNEE DEVICE, EXTENSION/FLEXION WITH OR WITHOUT RANGE
OF MOTION ADJUSTMENT, INCLUDES CUFFS”. Revised code E1811 adequately
describes the product that is the subject of this request.

Medicare Payment:
The fee schedule and payment rules associated with existing code apply to this product.
Pricing = 36
31

Summary of Primary Speaker Comments at the Public Meeting:


The primary speaker disagreed with CMS’ preliminary decision. The speaker claimed
that these devices are used for patient actuated serial stretch (PASS) treatment, which is
different from static progressive stretch (SPS) treatment systems. The speaker stated that
the differences in PASS and SPS include magnitude, timing; application of load to the
joint; point of use considerations of the patient population; and differences in design,
manufacturing, maintenance and clinical application demands. The speaker requested
that PASS be specified in code language.
32

HCPCS Public Meeting Agenda Item #15


May 3, 2007

Attachment: #07.103

Topic/Issue:
Request to establish a code for a patient actuated serial stretch shoulder machine, trade
name: Shoulder Flexionater. Suggested Language: “Patient actuated serial stretch
shoulder machine, variable load/variable position, patient controlled, with hydraulic
pump”.

Background/Discussion:
According to the requestor, the Shoulder Flexionater® is a self-contained machine that
facilitates and accelerates recovery from decreased range of motion of the shoulder by
isolating and treating decreased glenohumeral abduction and external rotation without
stressing the other joints of the shoulder. The device is designed to address the needs of
patients with arthrofibrosis, a condition in which an excessive scar tissue response leads
to painful restriction of shoulder mobility. The shoulder flexionater is a fully patient
controlled, variable load/variable position medical device that utilizes a hydraulic pump
and quick-release mechanism that allows patients to perform stretching therapy sessions,
alternately stretching and relaxing the scar tissue and adhesions surrounding the affected
joints. This technique is referred to as the Patient Actuated Serial Stretch (PASS)
protocol, which is unique to the product line, and follows the well established principles
of Total End Range Time (TERT) for stretching soft tissues.

CMS HCPCS Workgroup Preliminary Decision:


Revise existing code E1841 which currently reads: “MULTI-DIRECTIONAL STATIC
PROGRESSIVE STRETCH SHOULDER DEVICE, WITH RANGE OF MOTION
ADJUSTABILITY, INCLUDES CUFFS” to instead read: “STATIC PROGRESSIVE
STRETCH SHOULDER DEVICE, WITH OR WITHOUT RANGE OF MOTION
ADJUSTMENTS, INCLUDES CUFF”. Revised code E1841 adequately describes the
product that is the subject of this request.

Medicare Payment:
The fee schedule and payment rules associated with existing code apply to this product.
Pricing = 36

Summary of Primary Speaker Comments at the Public Meeting:


The primary speaker disagreed with CMS’ preliminary decision. The speaker claimed
that these devices are used for patient actuated serial stretch (PASS) treatment, which is
different from static progressive stretch (SPS) treatment systems. The speaker stated that
the differences in PASS and SPS include magnitude, timing; application of load to the
joint; point of use considerations of the patient population; and differences in design,
manufacturing, maintenance and clinical application demands. The speaker requested
that PASS be specified in code language.
33

HCPCS Public Meeting Agenda Item #15


May 3, 2007

Attachment: #07.104

Topic/Issue:
Request to establish a code for a patient actuated serial stretch knee extension device,
trade name: Knee Extensionater II. Suggested Language: “Patient actuated serial stretch
knee extension device, variable load/variable position, patient controlled, with pneumatic
pump.

Background/Discussion:
According to the requestor, the Knee Extensionater II is used to treat patients with
decreased range of motion due to arthrofibrosis, a complication of injury or surgery
where an excessive scar tissue response leads to painful restriction of knee motion. It is a
self-contained machine that facilitates and accelerates recovery from decreased range of
motion of the knee joint. It is fully patient controlled, variable load/variable position
medical equipment that utilizes a pneumatic hand pump, air bladder and quick-release
mechanism to allow patients to perform stretching therapy sessions, alternately stretching
and relaxing the scar tissue and adhesions surrounding the affected joints. This technique
is referred to as the Patient Actuated Serial Stretch (PASS) protocol, which is unique to
the product line, and follows the well established principles of Total End Range Time
(TERT) for stretching soft tissues. The Knee Extensionater II utilizes patient controlled,
variable loading forces to stretch the scar tissue gradually and increases joint range of
motion over the course of therapy following the TERT formula.

CMS HCPCS Workgroup Preliminary Decision:


Revise code E1811 which currently reads: “BI-DIRECTIONAL STATIC
PROGRESSIVE STRETCH KNEE DEVICE WITH RANGE OF MOTION
ADJUSTMENT, INCLUDES CUFFS” to instead read: “STATIC PROGRESSIVE
STRETCH KNEE DEVICE, EXTENSION/FLEXION WITH OR WITHOUT RANGE
OF MOTION ADJUSTMENT, INCLUDES CUFFS”. Revised code E1811 adequately
describes the product that is the subject of your request.

Medicare Payment:
The fee schedule and payment rules associated with existing code apply to this product.
Pricing = 36

Summary of Primary Speaker Comments at the Public Meeting:


The primary speaker disagreed with CMS’ preliminary decision. The speaker claimed
that these devices are used for patient actuated serial stretch (PASS) treatment, which is
different from static progressive stretch (SPS) treatment systems. The speaker stated that
the differences in PASS and SPS include magnitude, timing; application of load to the
joint; point of use considerations of the patient population; and differences in design,
manufacturing, maintenance and clinical application demands. The speaker requested
that PASS be specified in code language.
34

HCPCS Public Meeting Agenda Item #15


May 3, 2007

Attachment: #07.105

Topic/Issue:
Request to establish a code for a patient actuated serial stretch MPJ (Metatarsophalangeal
Joint) Extension/Flexion device, trade name: MPJ Extensionater. Suggested Language:
“Patient actuated serial stretch MPJ extension/flexion device, variable load/variable
position, patient controlled, with pneumatic pump.”

Background/Discussion:
According to the requestor, the MPJ Extensionater is used to treat patients with decreased
range of motion due to arthrofibrosis, a complication of injury or surgery where an
excessive scar tissue response leads to painful restriction of motion of the
metatarsophalangeal joint. The MPJ Extensionater is a self contained machine that
facilitates and accelerates recovery from decreased range of motion of the first
metatarsophalangeal joint (MPJ). The MPJ Extensionater is a full patient controlled,
variable load/variable position medical equipment that utilizes a pneumatic hand pump,
air bladder and quick-release mechanism to allow patients to perform stretching therapy
sessions, alternately stretching and relaxing the scar tissue and adhesions surrounding the
affected joints. This technique is referred to as the Patient Actuated Serial Stretch
(PASS) protocol, which is unique to the product line, and follows the well established
principles of Total End Range Time (TERT) for stretching soft tissues. The requestor
also notes that studies indicate short periods of intermittent joint loading, as prescribed by
the PASS protocol, pose less threat to the health of the articular and fibro-cartilage of the
joint than longer periods of continuous loading.

CMS HCPCS Workgroup Preliminary Decision:


Existing code E1399 “DURABLE MEDICAL EQUIPMENT, MISELLANEOUS” is
available for assignment by insurers if they deem appropriate. Your reported sales
volume was insufficient to support the establishment of a new national code. In
accordance with HCPCS coding criteria as published on CMS’ HCPCS website, there
must be sufficient claims activity or volume, as evidenced by 3 months of marketing
activity, so that the adding of a new or modified code enhances the efficiency of the
system and justifies the administrative burden of adding or modifying a code. CMS will
be happy to consider an application in a later coding cycle if sales volume increases
substantially.

Medicare Payment:
The fee schedule and payment rules associated with existing code apply to this product.
Pricing = 46
35

Summary of Primary Speaker Comments at the Public Meeting:


The primary speaker disagreed with CMS’ preliminary decision and stated that HCPCS
codes do not adequately describe this device.
36

HCPCS Public Meeting Agenda Item #15


May 3, 2007

Attachment: #07.106

Topic/Issue:
Request to establish a code for a patient actuated serial stretch elbow extension/flexion
device, trade name: Elbow Extensionater. Suggested Language: “Patient actuated serial
stretch Elbow extension/flexion device, variable load/variable position, patient
controlled, with pneumatic pump.”

Background/Discussion:
According to the requestor, the Elbow Extensionater is used to treat patients with
decreased elbow range of motion due to arthrofibrosis, a complication of injury or
surgery where an excessive scar tissue response leads to painful restriction of elbow
motion. The Elbow Extensionater is a self contained device that facilitates and
accelerates recovery from decreased range of motion of the elbow joint. The Elbow
Extensionater, which works both extension and flexion, is a total patient controlled,
variable load/variable position medical equipment that utilizes a pneumatic hand pump,
air bladder and quick-release mechanism to allow patients to perform stretching therapy
sessions, alternately stretching and relaxing the scar tissue and adhesions surrounding the
affected joints. This technique is referred to as the Patient Actuated Serial Stretch
(PASS) protocol, which is unique to the product line, and follows the well established
principles of Total End Range Time (TERT) for stretching soft tissues. The requestor
also notes that studies indicate short periods of intermittent joint loading, as prescribed by
the PASS protocol, pose less threat to the health of the articular and fibro-cartilage of the
joint than longer periods of continuous loading. L3740 “Elbow orthoses, double upright
with forearm/arm cuffs, adjustable position lock with active control, custom-fabricated”
has been used to describe this product. The requestor believes that this code is not
adequate because it describes orthotics or brace-like devices, which are not designed to
address motion loss or to improve range of motion.

CMS HCPCS Workgroup Preliminary Decision:


Revise code E1801, which currently reads: “BI-DIRECTIONAL STATIC
PROGRESSIVE STRETCH ELBOW DEVICE WITH RANGE OF MOTION
ADJUSTMENT, INCLUDES CUFFS” to instead read: “STATIC PROGRESSIVE
STRETCH ELBOW DEVICE, EXTENSION/FLEXION, WITH OR WITHOUT
RANGE OF MOTION ADJUSTMENT, INCLUDES CUFF”. Revised code E1811
adequately describes the product that is the subject of your request.

Medicare Payment:
The fee schedule and payment rules associated with existing code apply to this product.
Pricing = 36
37

Summary of Primary Speaker Comments at the Public Meeting:


The primary speaker disagreed with CMS’ preliminary decision. The speaker claimed
that these devices are used for patient actuated serial stretch (PASS) treatment, which is
different from static progressive stretch (SPS) treatment systems. The speaker stated that
the differences in PASS and SPS include magnitude, timing; application of load to the
joint; point of use considerations of the patient population; and differences in design,
manufacturing, maintenance and clinical application demands. The speaker requested
that PASS be specified in code language.
38

HCPCS Public Meeting Agenda Item #16


May 3, 2007

Attachment: #07.134

Topic/Issue:
Request to establish a code for a cervical support brace, trade name: Seattle Pneu-Trac
Traction Collar. Requester’s suggested language: “Cervical Collar, two-part system,
provide immobilization and ambulatory traction to the cervical spine”

Background/Discussion:
According to the requester, the Pneu-Trac traction collar is a lightweight, pneumatic
controlled orthosis that provides traction during the patient’s normal activities. It is an
inflatable collar that allows the patient to vary air pressure to provide the desirable level
of cervical distraction. The Pneu-Trac relieves discomfort in the neck and shoulders
caused by cervical spine/disc abnormality. Since it is mobile the cervical traction can be
worn anywhere. The Pneu-Trac can be used for immobilization, traction, and ongoing
physical therapy in the home.

According to the requestor, there are no existing codes to describe a free-standing,


pneumatic traction device that applies pressure to the shoulders/mandible. Existing code
E0849 “Traction equipment, cervical, free-standing stand/frame, pneumatic, applying
traction force to other than mandible” would describe the Pneu-Trac except for the
verbiage, “applying traction force to other than mandible”. The Pneu-Trac is also an
ambulatory traction device, whereas the product that the E0849 code describes is used in
a recumbent position.

CMS HCPCS Workgroup Preliminary Decision:


Establish code EXXXX “CERVICAL TRACTION DEVICE, CERVICAL COLLAR
WITH INFLATABLE AIR BLADDER”.

Medicare Payment:
Based on guidance contained in an informal benefit category determination, we believe
that the items would be paid in accordance with the payment rules that apply to
Inexpensive and Other Routinely Purchased Items.

Summary of Primary Speaker Comments at the Public Meeting:


There was no primary speaker for this item.
39

PAYMENT FOR DMEPOS

DMEPOS

The term DMEPOS, which stands for durable medical equipment (DME), prosthetics,
orthotics and supplies, is used in the Medicare program to describe a set of Medicare Part
B device and supply benefits for which claims are processed by four DME Regional
Carriers (DMERCs). The Part B device benefits covered by this term include:

• DME – equipment used in the home which can withstand repeated use, is
primarily and customarily used to serve a medical purpose, and is generally not
useful in the absence of an illness or injury;
• Prosthetic Devices – devices that replace all or part of an internal body organ,
including ostomy, tracheostomy and urological supplies, parenteral and enteral
nutrients, equipment and supplies (PEN), intraocular lenses (IOLs), and one pair
of conventional eyeglasses or contact lenses after each cataract surgery;
• Prosthetics – artificial legs, arms, and eyes;
• Orthotics – rigid or semi-rigid leg, arm, back, and neck braces;
• Home Dialysis Supplies and Equipment
• Surgical Dressings
• Therapeutic Shoes and Inserts

Depending on the item or the setting in which the item is furnished, Medicare claims for
some of these items may also be processed by local carriers and fiscal intermediaries
(e.g., claims for DME implanted in an ambulatory surgical center are processed by local
carriers). Claims for DME and ostomy, tracheostomy and urological supplies furnished
by a home health agency are processed by Regional Home Health Intermediaries
(RHHIs).

Fee Schedule Payments

Prior to January 1, 1989, payment for most DMEPOS items and services was made on
the basis of the reasonable charge methodology. Reasonable charges are calculated using
suppliers’ charges and are limited by an inflation adjustment factor. Payment is still
made on a reasonable charge basis for home dialysis supplies and equipment and for
IOLs inserted in a physician’s office. There is a monthly limit per beneficiary on
payments for home dialysis supplies and equipment. Payment for most of the other
DMEPOS items and services is based on the lower of the actual charge for the item or a
fee schedule amount. The Part B deductible and 20 percent coinsurance both apply to the
DMEPOS items and services described above.

The Social Security Act requires that the DMEPOS fee schedule amounts be established
based on average reasonable charges made during a base period (e.g., July 1, 1986 thru
June 30, 1987 for prosthetic devices, prosthetics and orthotics). The fee schedule
amounts are increased by annual update factors. Because the reasonable charge data
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required by the law in establishing fee schedule amounts does not exist for new
DMEPOS items, the fee schedule amounts for new DMEPOS items are “gap-filled”
using fees for comparable items, supplier price lists, manufacturer suggested retail prices,
or wholesale prices plus a markup. The gap-filling methodology is used to estimate the
average reasonable charge for the item from the base period.

DMEPOS Payment Categories/HCPCS Pricing Indicators

The Social Security Act separates DMEPOS into different Medicare payment categories,
each with its own unique payment rules. The pricing indicators in the HCPCS identify
which major payment category a code falls under. The pricing indicators applicable to
DMEPOS are as follows:

• Pricing = 00 Service Not Separately Priced


Items or services described by the HCPCS codes that are either not covered under
Medicare Part B or for which payment is bundled into the payment some other
Medicare service or procedure.

• Pricing = 31 Frequently Serviced Items


Payment is generally made on a monthly rental fee schedule basis for items such
as ventilators that require frequent and substantial servicing in order to avoid risk
to the patient’s health.

• Pricing = 32 Inexpensive and Other Routinely Purchased Items


Payment is made on a purchase or rental fee schedule basis. This category
includes items that have a purchase price of $150 or less, are generally purchased
75 percent of the time or more, or which are accessories used in conjunction with
a nebulizer, aspirator, continuous airway pressure device, or intermittent assist
device with continuous airway pressure device. The beneficiary has the option to
acquire the item on a purchase or monthly rental basis. Total payments for the
item cannot exceed the purchase fee schedule amount for the item.

• Pricing = 33 Oxygen and Oxygen Equipment


Monthly fee schedule payments are made for furnishing oxygen and oxygen
equipment. An additional payment is made for those beneficiaries who require
portable oxygen. The beneficiary takes over ownership of the equipment after the
36th monthly payment is made, after which payment for delivery of contents
continues for patient owned gaseous or liquid systems.

• Pricing = 34 Supplies Necessary for the Effective Use of DME


Payment is made on a purchase fee schedule basis for supplies necessary for the
effective use of DME (e.g., lancets that draw blood for use in blood glucose
monitor).

• Pricing = 35 Surgical Dressings


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Payment is made on a purchase fee schedule basis for surgical dressings.

• Pricing = 36 Capped Rental Items


Payment is made on a monthly rental fee schedule basis. For items furnished on
or after January 1, 2006, the beneficiary takes over ownership of the item after the
13th rental payment is made. The rental fee for capped rental items for each of the
first 3 months of rental is equal to 10 percent of the purchase fee for the item.
The rental fee for months 4 through 13 is equal to 7.5 percent of the purchase fee
for the item. Power wheelchairs can be purchased in the first month.

• Pricing = 37 Ostomy, Tracheostomy and Urological Supplies


Payment is made on a purchase fee schedule basis for ostomy, tracheostomy and
urological supplies.

• Pricing = 38 Orthotics, Prosthetics, Prosthetic Devices, and Vision Services


(Prosthetic Lenses)
Payment is made on a purchase fee schedule basis for orthotics, prosthetics, and
prosthetic devices & lenses.

• Pricing = 39 Parenteral and Enteral Nutrition (PEN)


Payment is made on a purchase fee schedule basis for parenteral and enteral
nutrients and supplies. Payment is made on a purchase or rental fee schedule
basis for parenteral and enteral equipment. The beneficiary has the option to
acquire the item on a purchase or monthly rental basis.

• Pricing = 45 Customized DME


Payment is made for lump-sum purchase of DME that meets the Medicare
regulatory definition of customized DME at 42 CFR 414.224. The payment
amount is based on the carrier’s individual consideration of the item.

• Pricing = 46 Carrier Priced Item


For items falling under codes for miscellaneous or not otherwise classified items,
the fee schedule or reasonable charge payment amount, whichever is applicable,
is based on the carrier’s individual consideration of the item.

• Pricing = 52 Reasonable Charges


Payment continues to be made on a reasonable charge basis in accordance with
Medicare regulations at 42 CFR 405.500 for splints, casts, and other devices used
to reduce a fracture or dislocation, dialysis supplies and equipment, and
intraocular lenses (IOLs) inserted in physician’s offices.