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a guide toReimbursement of Intermittent Catheters

Know your options

Coloplast Corp.Minneapolis, MN 554111.800.533.0464 usmedweb@coloplast.com www.us.coloplast.com

M2116N 04.08

© 2008-04. All rights reserved. Coloplast Corp., Minneapolis, MN USA.

® is a registered trademark of Coloplast A/S or related companies.

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Intermittent catheterization is a covered Medicare benefit when basic coverage criteria are met and the individual or caregiver can perform the procedure. This booklet is provided by Coloplast to answer some basic questions about coding and reimbursement of intermittent catheters.

Disclaimer: The information in this document is informational only, general in nature, and does not cover all payers’ rules or policies. This information was obtained from third party sources and is subject to change without notice as a result of changes in reimbursement regulations and payer policies. This document represents no promise or guarantee by Coloplast Corp. regarding coverage or payment for products or procedures by CMS or other payers. Providers are responsible for reporting the codes that most accurately describe the patient’s medical condition, procedures performed and products used. Providers should check Medicare bulletins, manuals, program memoranda, and Medicare guidelines to ensure compliance with Medicare requirements. Inquiries should be directed to the appropriate other payer for non-Medicare coverage situations.

Coverage CriteriaIntermittent catheters are considered under Medicare to be a Prosthetic Benefit. That is, they replace all or part of an internal body organ or part of the function of a permanently inoperative or malfunctioning internal body organ. In order to meet the basic coverage criteria an individual must have permanent urinary incontinence or urinary

retention.

Utilization GuidelinesIntermittent catheterization is covered when basic coverage criteria are met and the patient or caregiver can perform the procedure.

For each episode of covered catheterization,

Medicare will cover:

One catheter (A4351, A4352) and an •

individual packet of lubricant (A4332); or

One sterile intermittent catheter kit (A4353) if •

additional coverage criteria (see below) are met.

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Intermittent catheterization using a sterile

intermittent catheter kit (A4353) is covered when

the patient requires catheterization and the patient

meets one of the following criteria (1-5):

The patient resides in a nursing facility, 1.

The patient is immunosuppressed, 2.

for example (not all-inclusive):

on a regimen of immunosuppressive •

drugs post-transplant,

on cancer chemotherapy, •

has AIDS, •

has a drug-induced state such as •

chronic oral corticosteroid use

The patient has radiologically documented 3.

vesico-ureteral reflux while on a program

of intermittent catheterization,

The patient is a spinal cord injured female 4.

with neurogenic bladder who is pregnant

(for duration of pregnancy only),

The patient has had distinct, recurrent urinary 5.

tract infections, while on a program of sterile

intermittent catheterization with A4351/

A4352 and sterile lubricant A4332, twice

within the 12-month prior to the initiation

of sterile intermittent catheter kits.

A patient would be considered to have a urinary

tract infection if they have a urine culture with

greater than 10,000 colony forming units of a

urinary pathogen AND concurrent presence of

one or more of the following signs, symptoms or

laboratory findings:

Fever (oral temperature greater •

than 38º C [100.4º F])

Systemic leukocytosis •

Change in urinary urgency, •

frequency, or incontinence

Appearance of new or increase in •

autonomic dysreflexia (sweating,

bradycardia, blood pressure elevation)

Physical signs of prostatitis, epididymitis, orchitis •

Increased muscle spasms •

Pyuria (greater than 5 white blood cells •

[WBCs] per high-powered field)

Documentation RequirementsA doctor’s order or prescription is required to get

your intermittent catheter supplies and to begin the

claims process. This would include the beneficiary’s

name, detailed description of the item including

brand name, approximate quantity used per month,

start date of order, signature of treating physician,

and date the order was signed.

Additional medical records which support

permanent urinary incontinence or urinary retention

or information supporting medical necessity for

higher utilization than described may also be

necessary. A medical supplies dealer or pharmacy

should be able to assist you in the collection of this

information.

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Categories and Healthcare Common Procedure Coding System (HCPCS) CodesIntermittent catheters are classified into generic

descriptive categories and are assigned an

alphanumeric code. These HCPCS codes are used

when billing for your catheter supplies.

HCPCS Description

A4351 Intermittent urinary catheter; straight •

tip, with or without coating, each

A4352 Intermittent urinary catheter; coude •

(curved) tip, with or without coating, each

A4353 Intermittent urinary catheter, •

with insertion supplies

A4332 Lubricant, individual sterile •

packet, for insertion of urinary

catheter with sterile technique

The following table represents the usual maximum number of supplies:

Code (#/mo) A4332 (200)

A4351 (200)

A4352 (200)

A4353 (200)

Frequently Asked Questions:Q: How many intermittent catheters am I allowed each month under current Medicare guidelines?

A: As of April 1, 2008, Medicare will allow for the

usual maximum of 200 catheters per month or

one catheter for each episode of catheterization.

Intermittent catheters are a one-time use device that

should be discarded after each use.

Q: The policy contains a table describing the usual maximum number of supplies. Does this mean that every beneficiary should get 200 per month?

A: No. The usual maximum number represents

a determination of the number of items that

beneficiaries with extreme utilization requirements

will actually need. The typical beneficiary will require

a much lower amount. The beneficiary’s utilization

should be determined by the treating physician

based upon the patient’s medical condition. There

must be sufficient information in the medical record

to justify the amount ordered.

A beneficiary or caregiver must specifically

request refills of urological supplies before

they are dispensed. The supplier must not

automatically dispense a quantity of supplies on a

predetermined regular basis, even if the beneficiary

has “authorized” this in advance. The supplier

should check with the patient or caregiver prior to

dispensing a new supply of intermittent catheters

to determine that previous supplies are nearly

exhausted.

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Q: My Medicare supplier is working with me since I have a history of urinary tract infections (UTI), I am currently washing and reusing catheters (A4351, A4352) - i.e., using clean technique. I am just waiting for my doctor to send the lab results along with the UTI dates. Sometimes it takes 3 to 4 weeks for the doctors to respond to these requests. Are sterile catheter kits (A4353) covered for people in my situation?

A: No. If the beneficiary was not using sterile

catheter kits (A4353) prior to 4/1/2008, he/she

must meet the current criteria in order to be eligible

for reimbursement. Beneficiaries who have been

reusing intermittent catheters (A4351, A4352) with

clean technique at the rate of one catheter per

week are eligible to use a sterile catheter (A4351,

A4352) and a packet of sterile lubricant (A4332) for

each catheterization. The number of items needed

must be determined by the treating physician and

information in the medical record must justify the

need for the number of items prescribed.

Q: What if I do not have Medicare coverage but private insurance? How will this policy change affect me?

A: Please call your insurance provider to see if they

will follow the Medicare policy. Most insurance

companies do follow the guidelines set forth by

CMS (Centers for Medicare and Medicaid services).

Q: I have been unable to catheterize using a straight tip catheter and now require a coude tip, is there additional documentation necessary for coverage?

A: Yes, medical documentation is required to

support the necessity for a coude tip rather than

a straight tip. This should be documented in your

medical history file with your physician and can

be descriptive of your inability to successfully pass

a straight tip catheter or as the result of urethral

strictures.

The current Medicare guidelines indicate that a

coude tip is rarely medically necessary in female

patients, however, many female patients are

unable to pass a straight tip catheter and may find

benefit through the use of a coude tip catheter.

This experience should be documented in your

medical history file. Additionally, some clinicians

have determined that using an olive tip coude may

be helpful to women in the early learning stages of

intermittent self-catheterization.

Q: What if I need more supplies than are allowed in the Medicare guidelines?

A: If you need more supplies than are currently

allowed under Medicare guidelines your physician

will need to provide a letter explaining the need for

the additional supplies. Your medical supplier will

keep this letter on file.

Also, through the establishment of a history of

symptomatic recurrent urinary tract infections while

on a program of intermittent catheterization you are

eligible for a higher quantity of catheters or catheter

kits with insertion supplies.

Q: I am currently using straight intermittent catheters but am still having some problems with urinary tract infections. What can I do?

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A: You should talk to your physician/clinician and

discuss trying a Closed System intermittent catheter.

These products are “touchless” meaning your hands

do not have to touch the catheter. These products

are reimbursed under an A4353 HCPCS code and

require additional documentation.

Q: The policy on intermittent catheterization has been revised. The criteria for coverage of sterile kits, A4353, are slightly different from the previous criteria. The previous criteria required two infections while using “clean technique”. This revision requires two infections while using sterile, single-use catheters (A4351, A4352). Are current A4353 patients that qualified under clean technique grandfathered under this new policy?

A: Beneficiaries who were using A4353 sterile

catheter kits prior to April 1, 2008 and who met

the requirements for A4353 in the previous version

of the Urological Supplies LCD continue to be

eligible to receive sterile intermittent catheterization

kits. The medical record must contain sufficient

information to demonstrate that the applicable

coverage criteria were met.

Q: I don’t have a medical supplier. Can Coloplast help me locate one?

A: Yes, the Coloplast Customer Help Line at

800-525-8161 can introduce you to an authorized

supplier in your local area or an authorized national

supplier who will ship your supplies directly to your

home often at no charge to you.

Also, we can direct you to a supplier that accepts

assignment. A supplier that “accepts assignment”

will file a claim on your behalf directly with

Medicare. You will be responsible for the 20% co-

insurance and Medicare will pay its share of the bill

directly to the supplier.

Using a supplier that accepts assignment may result

in a significant out of pocket savings to you.

Q: I am having difficulty getting my particular Coloplast brand of catheters. What can I do?

A: All brands of intermittent catheters are

reimbursed under Medicare at the same $ allowable.

If you ever have problems getting our products,

please contact the Coloplast Help Line.

Q: My supplier bills Medicare for my product do I have to pay anything?

A: Yes. A supplier that accepts assignment for

Medicare will collect the 20% co-insurance of the

Medicare allowable amount for the product you are

purchasing.

A supplier that does not accept assignment may

require that you pay most of the entire bill at the

time you receive your supplies. However, the

supplier is still required to file a Medicare claim on

your behalf. Medicare then pays its share of the bill

directly to you.

Q: My supplier is telling me my catheters are not covered and I must pay for them. What can I do?

A: Intermittent catheters are a covered benefit under

Medicare (see Question1). There are many suppliers

that will help you with coverage to reduce your out

of pocket expenses.

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Q: Where is the best place to get my product if I don’t have insurance?

A: There are cash based suppliers that offer lower

prices for paying cash. They can offer lower prices

since they do not have the added administrative

expenses that go along with submitting insurance

claims.

Q: In an audit of a medical supplier, what information must be contained in the medical record to justify payment for both the type and quantity of urological supplies ordered by the treating physician?

A: For urological supplies to be covered by

Medicare, the patient’s medical record must contain

sufficient documentation of the patient’s medical

condition to substantiate the necessity for the

type and quantity of items ordered and for the

frequency of use or replacement. The information

should include the patient’s diagnosis and other

pertinent information including, but not limited to,

duration of the patient’s condition, clinical course

(worsening or improvement), prognosis, nature and

extent of functional limitations, other therapeutic

interventions and results, past experience

with related items, etc. Neither a physician’s

order nor a supplier-prepared statement nor a

physician attestation by itself provides sufficient

documentation of medical necessity, even though

it is signed by the treating physician. There must be

clinical information in the patient’s medical record

that supports the medical necessity for the item and

substantiates the information on a supplier-prepared

statement or physician attestation.

For intermittent catheterization, in addition to the

general information described above, the patient’s

medical record must contain a statement from

the physician specifying how often the patient (or

caregiver) performs catheterizations.

The patient’s medical record is not limited to the

physician’s office records. It may include hospital,

nursing home, or home health agency (HHA)

records, and records from other professionals

including, but not limited to, nurses, physical or

occupational therapists, prosthetists, and orthotists.

Q: I heard that the Department of Veterans Affairs recently changed their policy regarding intermittent catheterization and the use of sterile catheters. Is this true?

A: Yes. A December 13, 2007 informational letter

from the Under Secretary for Health of Department

of Veterans Affairs provides new guidance to

clinicians on the re-use of urinary catheters for those

who use intermittent catheterization for bladder

management.

VA clinicians under the new recommendations

should follow the manufacturer’s instructions for

catheter use. Catheters identified as single-use

devices should not be re-used in any setting. Users

should be provided with an adequate number

of catheters to use a new sterile catheter each

catheterization.

If you have any questions, call the Coloplast Help Line at 1-800-525-8161.

Notes

Disclaimer

The information in this document is informational only, general in nature, and does not cover all payers’ rules or policies. This information was obtained from third party sources and is subject to change without notice as a result of changes in reimbursement regulations and payer policies. This document represents no prom-ise or guarantee by Coloplast Corp. regarding coverage or payment for products or procedures by CMS or other payers. Providers are responsible for reporting the codes that most accurately describe the patient’s medical condition, procedures performed and products used. Providers should check Medicare bulletins, manuals, program memoranda, and Medicare guidelines to ensure compliance with Medicare requirements. Inquiries should be directed to the appropriate other payer for non-Medicare coverage situations.