Local Coverage Determination (LCD) for Nebulizers (L11499)

Local Coverage Determination (LCD) for Nebulizers (L11499)

Contractor Information Contract Number Contract Type
Contractor Name 16003 DME MAC
NHIC, Corp.

LCD Information Jurisdiction
Document Information Connecticut
District of Columbia
LCD Database ID Number Delaware
L11499 Massachusetts
Maryland
LCD Title Maine
Nebulizers New Hampshire
New Jersey
AMA CPT/ADA CDT Copyright Statement New York - Entire State
CPT only copyright 2002-2013 American Pennsylvania
Medical Association. All rights reserved. CPT is Rhode Island
a registered trademark of the American Vermont
Medical Association. Applicable FARS/DFARS
Apply to Government Use. Fee schedules, DME Region LCD Covers
relative value units, conversion factors and/or Jurisdiction A
related components are not assigned by the
AMA, are not part of CPT, and the AMA is not Original Effective Date
recommending their use. The AMA does not For services performed on or after 04/01/1997
directly or indirectly practice medicine or
dispense medical services. The AMA assumes Revision Effective Date
no liability for data contained or not contained For services performed on or after 07/01/2013
herein. The Code on Dental Procedures and
Nomenclature (Code) is published in Current Revision Ending Date
Dental Terminology (CDT). Copyright (c) N/A
American Dental Association. All rights
reserved. CDT and CDT-2010 are trademarks
of the American Dental Association.

Retirement Date
N/A

Notice Period Start Date
04/10/2008

Notice Period End Date
N/A

CMS National Coverage Policy
CMS Manual System, Pub. 100-3, Medicare National Coverage Determinations Manual, Chapter
1, Section 200.2, 280.1

Coverage Guidance
Coverage Indications, Limitations and/or Medical Necessity
For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit
category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to
improve the functioning of a malformed body member, and 3) meet all other applicable Medicare
statutory and regulatory requirements. For the items addressed in this local coverage

determination, the criteria for "reasonable and necessary", based on Social Security Act §
1862(a)(1)(A) provisions, are defined by the following coverage indications, limitations and/or
medical necessity.

For an item to be covered by Medicare, a detailed written order (DWO) must be received by the
supplier before a claim is submitted. If the supplier bills for an item addressed in this policy
without first receiving the completed DWO, the item will be denied as not reasonable and
necessary.

For some items in this policy to be covered by Medicare, a written order prior to delivery
(WOPD) is required. Refer to the DOCUMENTATION REQUIREMENTS section of this LCD and to
the NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES section of the related Policy
Article for information about WOPD prescription requirements.

A small volume nebulizer (A7003, A7004, A7005), related compressor (E0570) and FDA-
approved inhalation solutions of the drugs listed below are covered when:

a. It is reasonable and necessary to administer albuterol (J7611, J7613), arformoterol
(J7605), budesonide (J7626), cromolyn (J7631), formoterol (J7606), ipratropium (J7644),
levalbuterol (J7612, J7614), or metaproterenol (J7669) for the management of
obstructive pulmonary disease (Reference ICD-9 Codes that Support Medical Necessity
Group 8 Codes section for applicable ICD-9 diagnoses); or

b. It is reasonable and necessary to administer dornase alpha (J7639) to a beneficiary with
cystic fibrosis (Reference ICD-9 Codes that Support Medical Necessity Group 9 Codes
section for applicable ICD-9 diagnoses); or

c. It is reasonable and necessary to administer tobramycin (J7682) to a beneficiary with
cystic fibrosis or bronchiectasis (Reference ICD-9 Codes that Support Medical Necessity
Group 10 Codes section for applicable ICD-9 diagnoses); or

d. It is reasonable and necessary to administer pentamidine (J2545) to a beneficiary with
HIV, pneumocystosis, or complications of organ transplants (Reference ICD-9 Codes that
Support Medical Necessity Group 4 Codes section for applicable ICD-9 diagnoses); or

e. It is reasonable and necessary to administer acetylcysteine (J7608) for persistent thick or
tenacious pulmonary secretions (Reference ICD-9 Codes that Support Medical Necessity
Group 7 Codes section for applicable ICD-9 diagnoses).

Compounded inhalation solutions (J7604, J7607, J7609, J7610, J7615, J7622, J7624, J7627,
J7628, J7629, J7632, J7634, J7635, J7636, J7637, J7638, J7640, J7641, J7642, J7643, J7645,
J7647, J7650, J7657, J7660, J7667, J7670, J7676, J7680, J7681, J7683, J7684, J7685, and
compounded solutions billed with J7699) will be denied as not reasonable and necessary.

If none of the drugs used with a nebulizer are covered, the compressor, the nebulizer, and other
related accessories/supplies will be denied as not reasonable and necessary.

A large volume nebulizer (A7007, A7017), related compressor (E0565 or E0572), and water or
saline (A4217 or A7018) are covered when it is reasonable and necessary to deliver humidity to
a beneficiary with thick, tenacious secretions, who has cystic fibrosis, bronchiectasis, a
tracheostomy, or a tracheobronchial stent (Reference ICD-9 Codes that Support Medical
Necessity Group 5 Codes section for applicable ICD-9 diagnoses). Combination code E0585 will
be covered for the same indications.

An E0565 or E0572 compressor and filtered nebulizer (A7006) are also covered when it is
reasonable and necessary to administer pentamidine to beneficiaries with HIV, pneumocystosis,
or complications of organ transplants (Reference ICD-9 Codes that Support Medical Necessity
Group 1 Codes section for applicable ICD-9 diagnoses).

A small volume ultrasonic nebulizer (E0574) and related accessories are reasonable and
necessary to administer treprostinil inhalation solution only. Claims for code E0574 used with
other inhalation solutions will be denied as not reasonable and necessary.

Treprostinil inhalation solution (J7686) and iloprost (Q4074) are covered when all of the
following criteria 1-3 are met:

1. The beneficiary has a diagnosis of pulmonary artery hypertension (Reference ICD-9 Codes
that Support Medical Necessity Group 1 Codes section for applicable ICD-9 diagnoses);
and

2. The pulmonary hypertension is not secondary to pulmonary venous hypertension (e.g.,
left sided atrial or ventricular disease, left sided valvular heart disease, etc) or disorders of
the respiratory system (e.g., chronic obstructive pulmonary disease, interstitial lung
disease, obstructive sleep apnea or other sleep disordered breathing, alveolar
hypoventilation disorders, etc.); and

3. The beneficiary has primary pulmonary hypertension or pulmonary hypertension which is
secondary to one of the following conditions: connective tissue disease, thromboembolic
disease of the pulmonary arteries, human immunodeficiency virus (HIV) infection,
cirrhosis, anorexigens or congenital left to right shunts. If these conditions are present,
the following criteria (a-d) must be met:
a. The pulmonary hypertension has progressed despite maximal medical and/or
surgical treatment of the identified condition; and
b. The mean pulmonary artery pressure is > 25 mm Hg at rest or > 30 mm Hg with
exertion; and
c. The beneficiary has significant symptoms from the pulmonary hypertension (i.e.,
severe dyspnea on exertion, and either fatigability, angina, or syncope); and
d. Treatment with oral calcium channel blocking agents has been tried and failed, or
has been considered and ruled out

If the above criteria are not met, code E0574 and the related drug (J7686 for treprostinil) or
code K0730 and the related drug (Q4074 for iloprost) will be denied as not reasonable and
necessary.

A controlled dose inhalation drug delivery system (K0730) is covered when it is reasonable and
necessary to deliver iloprost (Q4074) to beneficiaries with pulmonary hypertension only
(Reference ICD-9 Codes that Support Medical Necessity Group 11 Codes section for applicable
ICD-9 diagnoses). Claims for code K0730 for use with other inhalation solutions will be denied as
not reasonable and necessary.

A large volume ultrasonic nebulizer (E0575) offers no proven clinical advantage over a
pneumatic compressor and nebulizer and will be denied as not reasonable and necessary.

ACCESSORIES:

Accessories are separately payable if the related aerosol compressor and the individual
accessories are reasonable and necessary. The following table lists the compressor/generator,
which is related to the accessories described. Other compressor/generator/accessory
combinations are considered not reasonable and necessary.

Compressor/Generator Related Accessories
E0565 A4619, A7006, A7007, A7010, A7011, A7012,
A7013, A7014, A7015, A7017, A7525, E1372
E0570 A7003, A7004, A7005, A7006, A7013, A7015,
A7525
E0572 A7006, A7014
E0574 A7013, A7014, A7016
E0585 A4619, A7006, A7010, A7011, A7012, A7013,
A7014, A7015, A7525
K0730 A7005

This array of accessories represents all possible combinations but it may not be appropriate to
bill any or all of them for one device.

The following table lists the usual maximum frequency of replacement for accessories. Claims for
more than the usual maximum replacement amount will be denied as not reasonable and
necessary.

Accessory Usual maximum replacement
A4619 One/month
A7003 Two/month
A7004
A7005 Two/month (in addition to A7003)
A7005 One/6 months
A7006
A7007 One/3 months only with K0730
A7010 One/month
A7011 Two/month
A7012
A7013 One unit (100 ft.)/2 months
A7014 One/year
A7015
A7016 Two/month
A7017 Two/month
A7525 One/3 months
E1372 One/month

Two/year
One/3 years
One/month
One/3 years

INHALATION DRUGS AND SOLUTIONS:

The following table represents the maximum milligrams/month of inhalation drugs that are
reasonable and necessary for each nebulizer drug.

Inhalation Drugs and Solutions Maximum Milligrams/Month
Acetylcysteine 74 grams/month
Albuterol 465 mg/month (See below for
exception)
Albuterol/Ipratropium combination 186 units/month
Arformoterol 930 micrograms/month – 62
units/month
Budesonide 62 units/month
Cromolyn sodium 2480 mg/month – 248 units/month
Dornase alpha 78 mg/month
Formoterol 1240 micrograms/month – 62
units/month
Ipratropium bromide 93 mg/month
Levalbuterol 232.5 mg/month – 465 units/month
(See below for exception)
Metaproterenol 2800 mg/month – 280 units/month
(See below for exception)
Pentamidine 300 mg/month
Treprostinil 31 units/month
Sterile saline or water, 10ml/unit 56 units/month
(A4216, A4218)
Distilled water, sterile water, or 18 liters/month
sterile saline in large volume
nebulizer

When albuterol, levalbuterol, or metaproterenol are prescribed as rescue/supplemental
medication for beneficiaries who are taking formoterol or arformoterol, the maximum
milligrams/month that are reasonably billed are:

Inhalation Drugs and Solutions Maximum Milligrams/Month
Albuterol 78 mg/month
Albuterol/Ipratroprium combination 31 units/month
Levalbuterol 39 mg/month – 78 units/month
Metaproterenol 470 mg/month – 47 units/month

Claims for more than these amounts of drugs will be denied as not reasonable and necessary.

When a "concentrated form" of an inhalation drug is covered, separate saline solution (A4216 or
A4218 [metered dose]) used to dilute it will be separately reimbursed. Saline dispensed for the
dilution of concentrated nebulizer drugs must be billed on the same claim as the drug(s) being
diluted. If the unit dose form of the drug is dispensed, separate saline solution (A4216 or A4218
[metered dose]), will be denied as not reasonable and necessary. Water or saline in 500 or 1000
ml quantities (A4217 or A7018) are not appropriate for use by beneficiaries to dilute inhalation
drugs and will therefore be denied as not reasonable and necessary if used for this purpose.
These codes are only reasonable and necessary when used in a large volume nebulizer (A7007,
A7017, or E0585).

Albuterol, levalbuterol, and metaproterenol are all short-acting bronchodilators with beta-
adrenergic stimulatory effect. It is not reasonable and necessary for a beneficiary to use more
than one of these at a time. The use of more than one of these drugs at the same time will be
denied as not reasonable and necessary.

Albuterol, levalbuterol, or metaproterenol is covered if it is used as a rescue/supplemental
medication in addition to the long-acting beta-adrenergic agonist drug, formoterol or
arformoterol.

Formoterol and arformoterol are long-acting bronchodilators with beta-adrenergic stimulatory
effect. It is not reasonable and necessary for a beneficiary to use more than one of these at a
time. The use of more than one of these drugs at the same time will be denied as not reasonable
and necessary.

Code J7620 describes the FDA-approved unit dose combination of albuterol base 2.5 mg and
ipratropium bromide 0.5 mg in unit dose vials. The medical necessity for administering additional
albuterol sulfate (J7611, J7613), levalbuterol (J7612, J7614) and/or ipratropium bromide
(J7644) has not been established. Claims for J7611-J7614 and J7644 billed in addition to J7620
will be denied as not reasonable and necessary.

Charges for the drugs, diluent, and dispensing fees may only be billed by the entity that actually
dispenses the drug to the Medicare beneficiary and that entity must be permitted under all
applicable federal, state, and local laws and regulations to dispense drugs. Only entities licensed
in the state where they are physically located may submit a claim for nebulizer drugs. Physicians
may submit a claim for drugs if all of the following conditions are met: the physician is 1)
enrolled as a Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) supplier
with the National Supplier Clearinghouse, and 2) dispensing the drug(s) to the Medicare
beneficiary, and 3) authorized by the State to dispense drugs as part of the physician’s license.
Claims submitted by entities not licensed to dispense drugs will be denied for lack of medical
necessity.

REFILL REQUIREMENTS

For DMEPOS items and supplies provided on a recurring basis, billing must be based on
prospective, not retrospective use. For DMEPOS products (A4619, A7003-A7017, A7525, all
inhalation medications) that are supplied as refills to the original order, suppliers must contact
the beneficiary prior to dispensing the refill and not automatically ship on a pre-determined
basis, even if authorized by the beneficiary. This shall be done to ensure that the refilled item
remains reasonable and necessary, existing supplies are approaching exhaustion, and to confirm
any changes/modifications to the order. Contact with the beneficiary or designee regarding refills
must take place no sooner than 14 calendar days prior to the delivery/shipping date. For
delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar
days prior to the end of usage for the current product. This is regardless of which delivery
method is utilized. (CMS’ Program Integrity Manual, Internet-Only Manual, CMS Pub. 100-8,
Chapter 5, Section 5.2.6).

For all DMEPOS items that are provided on a recurring basis, suppliers are required to have
contact with the beneficiary or caregiver/designee prior to dispensing a new supply of items.
Suppliers must not deliver refills without a refill request from a beneficiary. Items delivered
without a valid, documented refill request will be denied as not reasonable and necessary.

Suppliers must not dispense a quantity of supplies exceeding a beneficiary's expected utilization.
Suppliers must stay attuned to changed or atypical utilization patterns on the part of their
clients. Suppliers must verify with the ordering physicians that any changed or atypical
utilization is warranted. Regardless of utilization, a supplier must not dispense more than a three
(3)-month quantity at a time.

Coding Information
Bill Type Codes:
Contractors may specify Bill Types to help providers identify those Bill Types typically used to
report this service. Absence of a Bill Type does not guarantee that the policy does not apply to
that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill
Type and the policy should be assumed to apply equally to all claims.

Revenue Codes:
Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically
used to report this service. In most instances Revenue Codes are purely advisory; unless
specified in the policy services reported under other Revenue Codes are equally subject to this
coverage determination. Complete absence of all Revenue Codes indicates that coverage is not
influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue
Codes.

CPT/HCPCS Codes
Group 1 Paragraph: The appearance of a code in this section does not necessarily indicate
coverage.

HCPCS MODIFIERS:

EY - No physician or other licensed health care provider order for this item or service

GA - Waiver of liability statement issued as required by payer policy, individual case

GZ - Item or service expected to be denied as not reasonable and necessary

KO - Single drug unit dose formulation

KP - First drug of a multiple drug unit dose formulation

KQ - Second or subsequent drug of a multiple drug unit dose formulation

KX – Requirements specified in the medical policy have been met

HCPCS CODES:
EQUIPMENT

Group 1 Codes:
E0565 COMPRESSOR, AIR POWER SOURCE FOR EQUIPMENT WHICH IS NOT SELF- CONTAINED

OR CYLINDER DRIVEN
E0570 NEBULIZER, WITH COMPRESSOR
E0572 AEROSOL COMPRESSOR, ADJUSTABLE PRESSURE, LIGHT DUTY FOR INTERMITTENT

USE
E0574 ULTRASONIC/ELECTRONIC AEROSOL GENERATOR WITH SMALL VOLUME NEBULIZER
E0575 NEBULIZER, ULTRASONIC, LARGE VOLUME
E0585 NEBULIZER, WITH COMPRESSOR AND HEATER
K0730 CONTROLLED DOSE INHALATION DRUG DELIVERY SYSTEM

Group 2 Paragraph: ACCESSORIES
Group 2 Codes:
A4619 FACE TENT

A7003 ADMINISTRATION SET, WITH SMALL VOLUME NONFILTERED PNEUMATIC NEBULIZER,
DISPOSABLE

A7004 SMALL VOLUME NONFILTERED PNEUMATIC NEBULIZER, DISPOSABLE

A7005 ADMINISTRATION SET, WITH SMALL VOLUME NONFILTERED PNEUMATIC NEBULIZER,
NON-DISPOSABLE

A7006 ADMINISTRATION SET, WITH SMALL VOLUME FILTERED PNEUMATIC NEBULIZER

A7007 LARGE VOLUME NEBULIZER, DISPOSABLE, UNFILLED, USED WITH AEROSOL
COMPRESSOR

A7008 LARGE VOLUME NEBULIZER, DISPOSABLE, PREFILLED, USED WITH AEROSOL
COMPRESSOR

A7009 RESERVOIR BOTTLE, NON-DISPOSABLE, USED WITH LARGE VOLUME ULTRASONIC
NEBULIZER

A7010 CORRUGATED TUBING, DISPOSABLE, USED WITH LARGE VOLUME NEBULIZER, 100
FEET

A7011 CORRUGATED TUBING, NON-DISPOSABLE, USED WITH LARGE VOLUME NEBULIZER, 10
FEET

A7012 WATER COLLECTION DEVICE, USED WITH LARGE VOLUME NEBULIZER

A7013 FILTER, DISPOSABLE, USED WITH AEROSOL COMPRESSOR OR ULTRASONIC
GENERATOR

A7014 FILTER, NONDISPOSABLE, USED WITH AEROSOL COMPRESSOR OR ULTRASONIC
GENERATOR

A7015 AEROSOL MASK, USED WITH DME NEBULIZER

A7016 DOME AND MOUTHPIECE, USED WITH SMALL VOLUME ULTRASONIC NEBULIZER

A7017 NEBULIZER, DURABLE, GLASS OR AUTOCLAVABLE PLASTIC, BOTTLE TYPE, NOT USED
WITH OXYGEN

A7525 TRACHEOSTOMY MASK, EACH

E0580 NEBULIZER, DURABLE, GLASS OR AUTOCLAVABLE PLASTIC, BOTTLE TYPE, FOR USE
WITH REGULATOR OR FLOWMETER

E1372 IMMERSION EXTERNAL HEATER FOR NEBULIZER

Group 3 Paragraph: INHALATION DRUGS AND SOLUTIONS
Group 3 Codes:
A4216 STERILE WATER, SALINE AND/OR DEXTROSE, DILUENT/FLUSH, 10 ML

A4217 STERILE WATER/SALINE, 500 ML

A4218 STERILE SALINE OR WATER, METERED DOSE DISPENSER, 10 ML

A7018 WATER, DISTILLED, USED WITH LARGE VOLUME NEBULIZER, 1000 ML

G0333 PHARMACY DISPENSING FEE FOR INHALATION DRUG(S); INITIAL 30-DAY SUPPLY AS A
BENEFICIARY

J2545 PENTAMIDINE ISETHIONATE, INHALATION SOLUTION, FDA-APPROVED FINAL
PRODUCT, NON-COMPOUNDED, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER
300 MG

J7604 ACETYLCYSTEINE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED
THROUGH DME, UNIT DOSE FORM, PER GRAM

J7605 ARFORMOTEROL, INHALATION SOLUTION, FDA APPROVED FINAL PRODUCT, NON-
COMPOUNDED, ADMINISTERED THROUGH DME, UNIT DOSE FORM, 15 MICROGRAMS

J7606 FORMOTEROL FUMARATE, INHALATION SOLUTION, FDA APPROVED FINAL PRODUCT,
NON-COMPOUNDED, ADMINISTERED THROUGH DME, UNIT DOSE FORM, 20
MICROGRAMS

J7607 LEVALBUTEROL, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED
THROUGH DME, CONCENTRATED FORM, 0.5 MG

J7608 ACETYLCYSTEINE, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NON-
COMPOUNDED, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER GRAM

J7609 ALBUTEROL, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED
THROUGH DME, UNIT DOSE, 1 MG

J7610 ALBUTEROL, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED
THROUGH DME, CONCENTRATED FORM, 1 MG

J7611 ALBUTEROL, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NON-
COMPOUNDED, ADMINISTERED THROUGH DME, CONCENTRATED FORM, 1 MG

J7612 LEVALBUTEROL, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NON-
COMPOUNDED, ADMINISTERED THROUGH DME, CONCENTRATED FORM, 0.5 MG

J7613 ALBUTEROL, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NON-
COMPOUNDED, ADMINISTERED THROUGH DME, UNIT DOSE, 1 MG

J7614 LEVALBUTEROL, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NON-
COMPOUNDED, ADMINISTERED THROUGH DME, UNIT DOSE, 0.5 MG

J7615 LEVALBUTEROL, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED
THROUGH DME, UNIT DOSE, 0.5 MG

J7620 ALBUTEROL, UP TO 2.5 MG AND IPRATROPIUM BROMIDE, UP TO 0.5 MG, FDA-
APPROVED FINAL PRODUCT, NON-COMPOUNDED, ADMINISTERED THROUGH DME

J7622 BECLOMETHASONE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED
THROUGH DME, UNIT DOSE FORM, PER MILLIGRAM

J7624 BETAMETHASONE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED
THROUGH DME, UNIT DOSE FORM, PER MILLIGRAM

J7626 BUDESONIDE, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NON-
COMPOUNDED, ADMINISTERED THROUGH DME, UNIT DOSE FORM, UP TO 0.5 MG

J7627 BUDESONIDE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED
THROUGH DME, UNIT DOSE FORM, UP TO 0.5 MG

J7628 BITOLTEROL MESYLATE, INHALATION SOLUTION, COMPOUNDED PRODUCT,
ADMINISTERED THROUGH DME, CONCENTRATED FORM, PER MILLIGRAM

J7629 BITOLTEROL MESYLATE, INHALATION SOLUTION, COMPOUNDED PRODUCT,
ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER MILLIGRAM

J7631 CROMOLYN SODIUM, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NON-
COMPOUNDED, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER 10
J7632 MILLIGRAMS
J7634
J7635 CROMOLYN SODIUM, INHALATION SOLUTION, COMPOUNDED PRODUCT,
J7636 ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER 10 MILLIGRAMS
J7637
J7638 BUDESONIDE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED
J7639 THROUGH DME, CONCENTRATED FORM, PER 0.25 MILLIGRAM
J7640
J7641 ATROPINE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED
J7642 THROUGH DME, CONCENTRATED FORM, PER MILLIGRAM
J7643
J7644 ATROPINE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED
THROUGH DME, UNIT DOSE FORM, PER MILLIGRAM
J7645
J7647 DEXAMETHASONE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED
J7650 THROUGH DME, CONCENTRATED FORM, PER MILLIGRAM
J7657
J7660 DEXAMETHASONE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED
J7667 THROUGH DME, UNIT DOSE FORM, PER MILLIGRAM
J7669
DORNASE ALFA, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NON-
COMPOUNDED, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER MILLIGRAM

FORMOTEROL, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED
THROUGH DME, UNIT DOSE FORM, 12 MICROGRAMS

FLUNISOLIDE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED
THROUGH DME, UNIT DOSE, PER MILLIGRAM

GLYCOPYRROLATE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED
THROUGH DME, CONCENTRATED FORM, PER MILLIGRAM

GLYCOPYRROLATE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED
THROUGH DME, UNIT DOSE FORM, PER MILLIGRAM

IPRATROPIUM BROMIDE, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT,
NON-COMPOUNDED, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER
MILLIGRAM

IPRATROPIUM BROMIDE, INHALATION SOLUTION, COMPOUNDED PRODUCT,
ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER MILLIGRAM

ISOETHARINE HCL, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED
THROUGH DME, CONCENTRATED FORM, PER MILLIGRAM

ISOETHARINE HCL, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED
THROUGH DME, UNIT DOSE FORM, PER MILLIGRAM

ISOPROTERENOL HCL, INHALATION SOLUTION, COMPOUNDED PRODUCT,
ADMINISTERED THROUGH DME, CONCENTRATED FORM, PER MILLIGRAM

ISOPROTERENOL HCL, INHALATION SOLUTION, COMPOUNDED PRODUCT,
ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER MILLIGRAM

METAPROTERENOL SULFATE, INHALATION SOLUTION, COMPOUNDED PRODUCT,
CONCENTRATED FORM, PER 10 MILLIGRAMS

METAPROTERENOL SULFATE, INHALATION SOLUTION, FDA-APPROVED FINAL
PRODUCT, NON-COMPOUNDED, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER
10 MILLIGRAMS

J7670 METAPROTERENOL SULFATE, INHALATION SOLUTION, COMPOUNDED PRODUCT,
ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER 10 MILLIGRAMS

J7676 PENTAMIDINE ISETHIONATE, INHALATION SOLUTION, COMPOUNDED PRODUCT,
ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER 300 MG

J7680 TERBUTALINE SULFATE, INHALATION SOLUTION, COMPOUNDED PRODUCT,
ADMINISTERED THROUGH DME, CONCENTRATED FORM, PER MILLIGRAM

J7681 TERBUTALINE SULFATE, INHALATION SOLUTION, COMPOUNDED PRODUCT,
ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER MILLIGRAM

J7682 TOBRAMYCIN, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NON-
COMPOUNDED, UNIT DOSE FORM, ADMINISTERED THROUGH DME, PER 300
MILLIGRAMS

J7683 TRIAMCINOLONE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED
THROUGH DME, CONCENTRATED FORM, PER MILLIGRAM

J7684 TRIAMCINOLONE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED
THROUGH DME, UNIT DOSE FORM, PER MILLIGRAM

J7685 TOBRAMYCIN, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED
THROUGH DME, UNIT DOSE FORM, PER 300 MILLIGRAMS

J7686 TREPROSTINIL, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NON-
COMPOUNDED, ADMINISTERED THROUGH DME, UNIT DOSE FORM, 1.74 MG

J7699 NOC DRUGS, INHALATION SOLUTION ADMINISTERED THROUGH DME

Q0513 PHARMACY DISPENSING FEE FOR INHALATION DRUG(S); PER 30 DAYS

Q0514 PHARMACY DISPENSING FEE FOR INHALATION DRUG(S); PER 90 DAYS

Q4074 ILOPROST, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NON-
COMPOUNDED, ADMINISTERED THROUGH DME, UNIT DOSE FORM, UP TO 20
MICROGRAMS

ICD-9 Codes that Support Medical Necessity
Group 1 Paragraph: The presence of an ICD-9 code listed in this section is not sufficient by
itself to assure coverage. Refer to the section on “Coverage Indications, Limitations and/or
Medical Necessity” for other coverage criteria and payment information.

For HCPCS codes A4619, E0565, E0572:

Group 1 Codes:
011.50 - TUBERCULOUS BRONCHIECTASIS UNSPECIFIED EXAMINATION - TUBERCULOUS
011.56 BRONCHIECTASIS TUBERCLE BACILLI NOT FOUND BY BACTERIOLOGICAL OR

HISTOLOGICAL EXAMINATION BUT TUBERCULOSIS CONFIRMED BY OTHER
METHODS (INOCULATION OF ANIMALS)

042 HUMAN IMMUNODEFICIENCY VIRUS (HIV) DISEASE

136.3 PNEUMOCYSTOSIS

277.02 CYSTIC FIBROSIS WITH PULMONARY MANIFESTATIONS

494.0 BRONCHIECTASIS WITHOUT ACUTE EXACERBATION

494.1 BRONCHIECTASIS WITH ACUTE EXACERBATION

519.19 OTHER DISEASES OF TRACHEA AND BRONCHUS

748.61 CONGENITAL BRONCHIECTASIS

996.80 - COMPLICATIONS OF UNSPECIFIED TRANSPLANTED ORGAN - COMPLICATIONS OF
996.89 OTHER SPECIFIED TRANSPLANTED ORGAN

V44.0 TRACHEOSTOMY STATUS

V55.0 ATTENTION TO TRACHEOSTOMY

Group 1 Asterisk: N/A

Group 2 Paragraph: For HCPCS codes A7015, A7525:
Group 2 Codes:
011.50 - TUBERCULOUS BRONCHIECTASIS UNSPECIFIED EXAMINATION - TUBERCULOUS
011.56 BRONCHIECTASIS TUBERCLE BACILLI NOT FOUND BY BACTERIOLOGICAL OR

HISTOLOGICAL EXAMINATION BUT TUBERCULOSIS CONFIRMED BY OTHER
METHODS (INOCULATION OF ANIMALS)

042 HUMAN IMMUNODEFICIENCY VIRUS (HIV) DISEASE

136.3 PNEUMOCYSTOSIS

277.02 CYSTIC FIBROSIS WITH PULMONARY MANIFESTATIONS

480.0 - PNEUMONIA DUE TO ADENOVIRUS - RESPIRATORY CONDITIONS DUE TO
508.9 UNSPECIFIED EXTERNAL AGENT

519.19 OTHER DISEASES OF TRACHEA AND BRONCHUS

748.61 CONGENITAL BRONCHIECTASIS

786.4 ABNORMAL SPUTUM

996.80 - COMPLICATIONS OF UNSPECIFIED TRANSPLANTED ORGAN - COMPLICATIONS OF
996.89 OTHER SPECIFIED TRANSPLANTED ORGAN

V44.0 TRACHEOSTOMY STATUS

V55.0 ATTENTION TO TRACHEOSTOMY

Group 2 Asterisk: N/A

Group 3 Paragraph: For HCPCS codes A7003, A7004, E0570:
Group 3 Codes:
011.50 - TUBERCULOUS BRONCHIECTASIS UNSPECIFIED EXAMINATION - TUBERCULOUS
011.56 BRONCHIECTASIS TUBERCLE BACILLI NOT FOUND BY BACTERIOLOGICAL OR

HISTOLOGICAL EXAMINATION BUT TUBERCULOSIS CONFIRMED BY OTHER
METHODS (INOCULATION OF ANIMALS)

042 HUMAN IMMUNODEFICIENCY VIRUS (HIV) DISEASE

136.3 PNEUMOCYSTOSIS

277.02 CYSTIC FIBROSIS WITH PULMONARY MANIFESTATIONS

480.0 - PNEUMONIA DUE TO ADENOVIRUS - RESPIRATORY CONDITIONS DUE TO
508.9 UNSPECIFIED EXTERNAL AGENT

748.61 CONGENITAL BRONCHIECTASIS

786.4 ABNORMAL SPUTUM

996.80 - COMPLICATIONS OF UNSPECIFIED TRANSPLANTED ORGAN - COMPLICATIONS OF
996.89 OTHER SPECIFIED TRANSPLANTED ORGAN

Group 3 Asterisk: N/A

Group 4 Paragraph: For HCPCS codes A7006, J2545:
Group 4 Codes:
042 HUMAN IMMUNODEFICIENCY VIRUS (HIV) DISEASE

136.3 PNEUMOCYSTOSIS

996.80 - COMPLICATIONS OF UNSPECIFIED TRANSPLANTED ORGAN - COMPLICATIONS OF
996.89 OTHER SPECIFIED TRANSPLANTED ORGAN

Group 4 Asterisk: N/A

Group 5 Paragraph: For HCPCS codes A4217, A7007, A7010, A7011, A7012, A7017, A7018,
E0585, E1372:
Group 5 Codes:
011.50 - TUBERCULOUS BRONCHIECTASIS UNSPECIFIED EXAMINATION - TUBERCULOUS
011.56 BRONCHIECTASIS TUBERCLE BACILLI NOT FOUND BY BACTERIOLOGICAL OR

HISTOLOGICAL EXAMINATION BUT TUBERCULOSIS CONFIRMED BY OTHER
METHODS (INOCULATION OF ANIMALS)

277.02 CYSTIC FIBROSIS WITH PULMONARY MANIFESTATIONS

494.0 BRONCHIECTASIS WITHOUT ACUTE EXACERBATION

494.1 BRONCHIECTASIS WITH ACUTE EXACERBATION

519.19 OTHER DISEASES OF TRACHEA AND BRONCHUS

748.61 CONGENITAL BRONCHIECTASIS

V44.0 TRACHEOSTOMY STATUS

V55.0 ATTENTION TO TRACHEOSTOMY

Group 5 Asterisk: N/A

Group 6 Paragraph: For HCPCS code A4216:
Group 6 Codes:
042 HUMAN IMMUNODEFICIENCY VIRUS (HIV) DISEASE

136.3 PNEUMOCYSTOSIS

491.0 - SIMPLE CHRONIC BRONCHITIS - RESPIRATORY CONDITIONS DUE TO
508.9 UNSPECIFIED EXTERNAL AGENT

996.80 - COMPLICATIONS OF UNSPECIFIED TRANSPLANTED ORGAN - COMPLICATIONS OF
996.89 OTHER SPECIFIED TRANSPLANTED ORGAN

Group 6 Asterisk: N/A

Group 7 Paragraph: For HCPCS codes J7608:

Group 7 Codes:

480.0 - PNEUMONIA DUE TO ADENOVIRUS - RESPIRATORY CONDITIONS DUE TO

508.9 UNSPECIFIED EXTERNAL AGENT

786.4 ABNORMAL SPUTUM

Group 7 Asterisk: N/A

Group 8 Paragraph: For HCPCS codes J7605, J7606, J7611, J7612, J7613, J7614, J7620,

J7626, J7631, J7644, J7669:

Group 8 Codes:

491.0 - SIMPLE CHRONIC BRONCHITIS - RESPIRATORY CONDITIONS DUE TO

508.9 UNSPECIFIED EXTERNAL AGENT

Group 8 Asterisk: N/A

Group 9 Paragraph: For HCPCS code J7639:
Group 9 Codes:
277.02 CYSTIC FIBROSIS WITH PULMONARY MANIFESTATIONS

Group 9 Asterisk: N/A

Group 10 Paragraph: For HCPCS code J7682:
Group 10 Codes:
011.50 - TUBERCULOUS BRONCHIECTASIS UNSPECIFIED EXAMINATION - TUBERCULOUS
011.56 BRONCHIECTASIS TUBERCLE BACILLI NOT FOUND BY BACTERIOLOGICAL OR

HISTOLOGICAL EXAMINATION BUT TUBERCULOSIS CONFIRMED BY OTHER
METHODS (INOCULATION OF ANIMALS)

277.02 CYSTIC FIBROSIS WITH PULMONARY MANIFESTATIONS

494.0 BRONCHIECTASIS WITHOUT ACUTE EXACERBATION

494.1 BRONCHIECTASIS WITH ACUTE EXACERBATION

748.61 CONGENITAL BRONCHIECTASIS

Group 10 Asterisk: N/A

Group 11 Paragraph: For HCPCS codes A7016, E0574, J7686 K0730, Q4074
Group 11 Codes:
416.0 PRIMARY PULMONARY HYPERTENSION

416.8 OTHER CHRONIC PULMONARY HEART DISEASES

Group 11 Asterisk: N/A

Group 12 Paragraph: For HCPCS code A7005:
Group 12 Codes:
011.50 - TUBERCULOUS BRONCHIECTASIS UNSPECIFIED EXAMINATION - TUBERCULOUS
011.56 BRONCHIECTASIS TUBERCLE BACILLI NOT FOUND BY BACTERIOLOGICAL OR

HISTOLOGICAL EXAMINATION BUT TUBERCULOSIS CONFIRMED BY OTHER
METHODS (INOCULATION OF ANIMALS)

042 HUMAN IMMUNODEFICIENCY VIRUS (HIV) DISEASE

136.3 PNEUMOCYSTOSIS

277.02 CYSTIC FIBROSIS WITH PULMONARY MANIFESTATIONS

416.0 PRIMARY PULMONARY HYPERTENSION

416.8 OTHER CHRONIC PULMONARY HEART DISEASES

480.0 - PNEUMONIA DUE TO ADENOVIRUS - RESPIRATORY CONDITIONS DUE TO
508.9 UNSPECIFIED EXTERNAL AGENT

748.61 CONGENITAL BRONCHIECTASIS

786.4 ABNORMAL SPUTUM

996.80 - COMPLICATIONS OF UNSPECIFIED TRANSPLANTED ORGAN - COMPLICATIONS OF
996.89 OTHER SPECIFIED TRANSPLANTED ORGAN

Group 12 Asterisk: N/A

Group 13 Paragraph: For HCPCS codes A7013, A7014
Group 13 Codes:
011.50 - TUBERCULOUS BRONCHIECTASIS UNSPECIFIED EXAMINATION - TUBERCULOUS
011.56 BRONCHIECTASIS TUBERCLE BACILLI NOT FOUND BY BACTERIOLOGICAL OR

HISTOLOGICAL EXAMINATION BUT TUBERCULOSIS CONFIRMED BY OTHER
METHODS (INOCULATION OF ANIMALS)

042 HUMAN IMMUNODEFICIENCY VIRUS (HIV) DISEASE

136.3 PNEUMOCYSTOSIS

277.02 CYSTIC FIBROSIS WITH PULMONARY MANIFESTATIONS

416.0 PRIMARY PULMONARY HYPERTENSION

416.8 OTHER CHRONIC PULMONARY HEART DISEASES

480.0 - PNEUMONIA DUE TO ADENOVIRUS - RESPIRATORY CONDITIONS DUE TO
508.9 UNSPECIFIED EXTERNAL AGENT

519.19 OTHER DISEASES OF TRACHEA AND BRONCHUS

748.61 CONGENITAL BRONCHIECTASIS

786.4 ABNORMAL SPUTUM

996.80 - COMPLICATIONS OF UNSPECIFIED TRANSPLANTED ORGAN - COMPLICATIONS OF
996.89 OTHER SPECIFIED TRANSPLANTED ORGAN

V44.0 TRACHEOSTOMY STATUS

V55.0 ATTENTION TO TRACHEOSTOMY

Group 13 Asterisk: N/A

ICD-9 Codes that DO NOT Support Medical Necessity
For the specific HCPCS codes indicated above, all ICD-9 codes that are not specified in the
previous section.

For HCPCS codes A7009, E0575, J7604, J7607, J7609, J7610, J7615, J7622, J7624, J7627,
J7628, J7629, J7632, J7634, J7635, J7636, J7637, J7638, J7640, J7641, J7642, J7643, J7645,
J7647, J7650, J7657, J7660, J7667, J7670, J7676, J7680, J7681, J7683, J7684, and J7685, all
ICD-9 codes.

For all other HCPCS codes, ICD-9 codes are not specified.

General Information
Associated Information
DOCUMENTATION REQUIREMENTS

Section 1833(e) of the Social Security Act precludes payment to any provider of services unless
"there has been furnished such information as may be necessary in order to determine the
amounts due such provider.” It is expected that the beneficiary's medical records will reflect the
need for the care provided. The beneficiary's medical records include the physician's office
records, hospital records, nursing home records, home health agency records, records from
other healthcare professionals and test reports. This documentation must be available upon
request.

PRESCRIPTION (ORDER) REQUIREMENTS

GENERAL (PIM 5.2.1)

All items billed to Medicare require a prescription. An order for each item billed must be signed
and dated by the treating physician, kept on file by the supplier, and made available upon
request. Items dispensed and/or billed that do not meet these prescription requirements and
those below must be submitted with an EY modifier added to each affected HCPCS code.

DISPENSING ORDERS (PIM 5.2.2)

Equipment and supplies may be delivered upon receipt of a dispensing order except for those
items that require a written order prior to delivery. A dispensing order may be verbal or written.
The supplier must keep a record of the dispensing order on file. It must contain:

• Description of the item
• Beneficiary's name
• Prescribing Physician's name
• Date of the order and the start date, if the start date is different from the date of the

order
• Physician signature (if a written order) or supplier signature (if verbal order)

For the “Date of the order” described above, use the date the supplier is contacted by the
physician (for verbal orders) or the date entered by the physician (for written dispensing
orders).

Signature and date stamps are not allowed. Signatures must comply with the CMS signature
requirements outlined in PIM 3.3.2.4.

The dispensing order must be available upon request.

For items that are provided based on a dispensing order, the supplier must obtain a detailed
written order before submitting a claim.

WRITTEN ORDERS PRIOR TO DELIVERY (PIM 5.2.3.1)

ACA 6407 requires a written order prior to delivery (WOPD) for the HCPCS codes specified in the
table contained in the Policy Specific Documentation Requirements Section below. The supplier
must have received a complete WOPD that has been both signed and dated by the treating
physician and meets the requirements for a DWO before dispensing the item. Refer the related
Policy Article NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES section for
information about the statutory requirements associated with a WOPD.

DETAILED WRITTEN ORDERS (PIM 5.2.3)

A detailed written order (DWO) is required before billing. Someone other than the ordering
physician may produce the DWO. However, the ordering physician must review the content and
sign and date the document. It must contain:

• Beneficiary's name
• Physician's name
• Date of the order and the start date, if start date is different from the date of the order
• Detailed description of the item(s) (see below for specific requirements for selected items)
• Physician signature and signature date

For items provided on a periodic basis, including drugs, the written order must include:
• Item(s) to be dispensed
• Dosage or concentration, if applicable
• Route of Administration
• Frequency of use
• Duration of infusion, if applicable
• Quantity to be dispensed
• Number of refills

For the “Date of the order” described above, use the date the supplier is contacted by the
physician (for verbal orders) or the date entered by the physician (for written dispensing
orders).

Frequency of use information on orders must contain detailed instructions for use and specific
amounts to be dispensed. Reimbursement shall be based on the specific utilization amount only.
Orders that only state “PRN” or “as needed” utilization estimates for replacement frequency,
use, or consumption are not acceptable. (PIM 5.9)

The detailed description in the written order may be either a narrative description or a brand
name/model number.

Signature and date stamps are not allowed. Signatures must comply with the CMS signature
requirements outlined in PIM 3.3.2.4.

The DWO must be available upon request.

A prescription is not considered as part of the medical record. Medical information intended to
demonstrate compliance with coverage criteria may be included on the prescription but must be
corroborated by information contained in the medical record.

The order for any drug must clearly specify the type of solution to be dispensed to the
beneficiary and the administration instructions for that solution. The type of solution is described
by a combination of (a) the name of the drug and the concentration of the drug in the dispensed
solution and the volume of solution in each container, or (b) the name of the drug and the
number of milligrams/grams of drug in the dispensed solution and the volume of solution in that
container.

Examples of (a) would be: albuterol 0.083% 3 ml; or albuterol 0.5% 20 ml; or cromolyn 20
mg/2 ml. An example of (b) is: albuterol 1.25 mg in 3 ml saline. For compounded inhalation
solutions, the order must include the following statement prior to signature by the physician:
compounded inhalation solution – not FDA-approved.

MEDICAL RECORD INFORMATION

GENERAL (PIM 5.7 - 5.9)

The Coverage Indications, Limitations and/or Medical Necessity section of this LCD
contains numerous reasonable and necessary (R&N) requirements. The Non-Medical Necessity
Coverage and Payment Rules section of the related Policy Article contains numerous non-
reasonable and necessary, benefit category and statutory requirements that must be met in
order for payment to be justified. Suppliers are reminded that:

• Supplier-produced records, even if signed by the ordering physician, and attestation
letters (e.g. letters of medical necessity) are deemed not to be part of a medical record
for Medicare payment purposes.

• Templates and forms, including CMS Certificates of Medical Necessity, are subject to
corroboration with information in the medical record.

Information contained directly in the contemporaneous medical record is the source required to
justify payment except as noted elsewhere for prescriptions and CMNs. The medical record is not
limited to physician’s office records but may include records from hospitals, nursing facilities,
home health agencies, other healthcare professionals, etc. (not all-inclusive). Records from
suppliers or healthcare professionals with a financial interest in the claim outcome are not
considered sufficient by themselves for the purpose of determining that an item is reasonable
and necessary.

CONTINUED MEDICAL NEED

For all DMEPOS items, the initial justification for medical need is established at the time the
item(s) is first ordered; therefore, beneficiary medical records demonstrating that the item is
reasonable and necessary are created just prior to, or at the time of, the creation of the initial
prescription. For purchased items, initial months of a rental item or for initial months of ongoing
supplies or drugs, information justifying reimbursement will come from this initial time period.
Entries in the beneficiary’s medical record must have been created prior to, or at the time of, the
initial DOS to establish whether the initial reimbursement was justified based upon the
applicable coverage policy.

For ongoing supplies and rental DME items, in addition to information described above that
justifies the initial provision of the item(s) and/or supplies, there must be information in the

beneficiary’s medical record to support that the item continues to be used by the beneficiary and
remains reasonable and necessary. Information used to justify continued medical need must be
timely for the DOS under review. Any of the following may serve as documentation justifying
continued medical need:

• A recent order by the treating physician for refills
• A recent change in prescription
• A properly completed CMN or DIF with an appropriate length of need specified
• Timely documentation in the beneficiary's medical record showing usage of the item

Timely documentation is defined as a record in the preceding 12 months unless otherwise
specified elsewhere in the policy.

CONTINUED USE

Continued use describes the ongoing utilization of supplies or a rental item by a beneficiary.

Suppliers are responsible for monitoring utilization of DMEPOS rental items and supplies. No
monitoring of purchased items or capped rental items that have converted to a purchase is
required. Suppliers must discontinue billing Medicare when rental items or ongoing supply items
are no longer being used by the beneficiary.

Beneficiary medical records or supplier records may be used to confirm that a DMEPOS item
continues to be used by the beneficiary. Any of the following may serve as documentation that
an item submitted for reimbursement continues to be used by the beneficiary:

• Timely documentation in the beneficiary's medical record showing usage of the item,
related option/accessories and supplies

• Supplier records documenting the request for refill/replacement of supplies in compliance
with the Refill Documentation Requirements (This is deemed to be sufficient to document
continued use for the base item, as well)

• Supplier records documenting beneficiary confirmation of continued use of a rental item

Timely documentation is defined as a record in the preceding 12 months unless otherwise
specified elsewhere in this policy.

REFILL DOCUMENTATION (PIM 5.2.5-6)

A routine refill prescription is not needed. A new prescription is needed when:
• There is a change of supplier
• There is a change in the item(s), frequency of use, or amount prescribed
• There is a change in the length of need or a previously established length of need expires
• State law requires a prescription renewal

For items that the beneficiary obtains in-person at a retail store, the signed delivery slip or a
copy of the itemized sales receipt is sufficient documentation of a request for refill.

For items that are delivered to the beneficiary, documentation of a request for refill must be
either a written document received from the beneficiary or a contemporaneous written record of
a phone conversation/contact between the supplier and beneficiary. The refill request must occur
and be documented before shipment. A retrospective attestation statement by the supplier or
beneficiary is not sufficient. The refill record must include:

• Beneficiary's name or authorized representative if different than the beneficiary
• A description of each item that is being requested
• Date of refill request

• For consumable supplies, i.e., those that are used up (e.g., ostomy or urological supplies,
surgical dressings, etc.) - the supplier should assess the quantity of each item that the
beneficiary still has remaining, to document that the amount remaining will be nearly
exhausted on or about the supply anniversary date.

• For non-consumable supplies, i.e., those more durable items that are not used up but
may need periodic replacement (e.g., PAP and RAD supplies) - the supplier should assess
whether the supplies remain functional, providing replacement (a refill) only when the
supply item(s) is no longer able to function. Document the functional condition of the
item(s) being refilled in sufficient detail to demonstrate the cause of the dysfunction that
necessitates replacement (refill).

This information must be kept on file and be available upon request.

PROOF OF DELIVERY (PIM 4.26, 5.8)

Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are required to maintain
POD documentation in their files. For medical review purposes, POD serves to assist in
determining correct coding and billing information for claims submitted for Medicare
reimbursement. Regardless of the method of delivery, the contractor must be able to determine
from delivery documentation that the supplier properly coded the item(s), that the item(s)
delivered are the same item(s) submitted for Medicare reimbursement and that the item(s) are
intended for, and received by, a specific Medicare beneficiary.

Suppliers, their employees, or anyone else having a financial interest in the delivery of the item
are prohibited from signing and accepting an item on behalf of a beneficiary (i.e., acting as a
designee on behalf of the beneficiary). The signature and date the beneficiary or designee
accepted delivery must be legible.

For the purpose of the delivery methods noted below, designee is defined as any person who can
sign and accept the delivery of durable medical equipment on behalf of the beneficiary.

Proof of delivery documentation must be available to the Medicare contractor on request. All
services that do not have appropriate proof of delivery from the supplier will be denied and
overpayments will be requested. Suppliers who consistently fail to provide documentation to
support their services may be referred to the OIG for imposition of Civil Monetary Penalties or
other administrative sanctions.

Suppliers are required to maintain POD documentation in their files. For the items addressed in
this policy, there are two methods of delivery:

1. Delivery directly to the beneficiary or authorized representative
2. Delivery via shipping or delivery service

Method 1—Direct Delivery to the Beneficiary by the Supplier

Suppliers may deliver directly to the beneficiary or the designee. In this case, POD to a
beneficiary must be a signed and dated delivery slip. The POD record must include:

• Beneficiary's name
• Delivery address
• Sufficiently detailed description to identify the item(s) being delivered (e.g., brand name,

serial number, narrative description)
• Quantity delivered

• Date delivered
• Beneficiary (or designee) signature and date of signature

The date of signature on the delivery slip must be the date that the DMEPOS item was received
by the beneficiary or designee. In instances where the supplies are delivered directly by the
supplier, the date the beneficiary received the DMEPOS supply must be the date of service on
the claim.

Method 2—Delivery via Shipping or Delivery Service Directly to a Beneficiary

If the supplier utilizes a shipping service or mail order, the POD documentation must be a
complete record tracking the item(s) from the DMEPOS supplier to the beneficiary. An example
of acceptable proof of delivery would include both the supplier's own detailed shipping invoice
and the delivery service's tracking information. The supplier's record must be linked to the
delivery service record by some clear method like the delivery service's package identification
number or supplier's invoice number for the package sent to the beneficiary. The POD record
must include:

• Beneficiary's name
• Delivery address
• Delivery service's package identification number, supplier invoice number or alternative

method that links the supplier's delivery documents with the delivery service's records.
• Sufficiently detailed description to identify the item(s) being delivered (e.g., brand name,

serial number, narrative description)
• Quantity delivered
• Date delivered
• Evidence of delivery

If a supplier utilizes a shipping service or mail order, suppliers must use the shipping date as the
date of service on the claim.

Suppliers may also utilize a return postage-paid delivery invoice from the beneficiary or designee
as a POD. This type of POD record must contain the information specified above.

POLICY SPECIFIC DOCUMENTATION REQUIREMENTS

AFFORDABLE CARE ACT (ACA) 6407 REQUIREMENTS

ACA 6407 contains provisions that are applicable to certain specified items in this policy. In this
policy the specified items are:

E0570 NEBULIZER, WITH COMPRESSOR

E0575 NEBULIZER, ULTRASONIC, LARGE VOLUME

E0580 NEBULIZER, DURABLE, GLASS OR AUTOCLAVABLE PLASTIC, BOTTLE TYPE, FOR USE
WITH REGULATOR OR FLOWMETER

E0585 NEBULIZER, WITH COMPRESSOR AND HEATER

K0730 CONTROLLED DOSE INHALATION DRUG DELIVERY SYSTEM

These items require an in-person or face-to-face interaction between the beneficiary and their
treating physician prior to prescribing the item, specifically to document that the beneficiary was
evaluated and/or treated for a condition that supports the need for the item(s) of DME ordered.
A dispensing order is not sufficient to provide these items. A Written Order Prior to Delivery
(WOPD) is required. Refer to the related Policy Article NON-MEDICAL NECESSITY COVERAGE
AND PAYMENT RULES section for information about these statutory requirements.

The DMEPOS supplier must have documentation of both the face-to-face visit and the completed
WOPD in their file prior to the delivery of these items.

Suppliers are reminded that all Medicare coverage and documentation requirements for DMEPOS
also apply. There must be sufficient information included in the medical record to demonstrate
that all of the applicable coverage criteria are met. This information must be available upon
request.

REPAIR/REPLACEMENT (BPM Ch 15, §110.2)

A new Certificate of Medical Necessity (CMN) and/or physician’s order is not needed for repairs.

The supplier must maintain detailed records describing the need for and nature of all repairs
including a detailed explanation of the justification for any component or part replaced as well as
the labor time.

A physician’s order and/or new Certificate of Medical Necessity (CMN), when required, is needed
to reaffirm the medical necessity of the item for replacement of an item.

KX, GA, AND GZ MODIFIERS:

Suppliers must add a KX modifier to codes for E0574, J7686, K0730 and Q4074 only if all of the
criteria in the Coverage Indications, Limitations and/or Medical Necessity” section of this policy
have been met.

If all of the criteria in the Coverage Indications, Limitations and/or Medical Necessity section
have not been met, the GA or GZ modifier must be added to the code. When there is an
expectation of a medical necessity denial, suppliers must enter GA modifier on the claim line if
they have obtained a properly executed Advance Beneficiary Notice (ABN) or GZ modifier if they
have not obtained a valid ABN.

Claim lines billed without a KX, GA, or GZ modifier will be rejected as missing information.

MISCELLANEOUS

An ICD-9 code describing the condition which necessitates nebulizer therapy must be included
on each claim for equipment, accessories, and/or drugs.

When code E1399 is billed for miscellaneous equipment or accessories, the claim must be
accompanied by a clear description of the item including the manufacturer and the model
name/number if applicable.

When Not Otherwise Classified (NOC) drug code J7699 is billed for miscellaneous inhalation
drugs, the claim must be accompanied by the detailed order information described above and a
clear statement of the number of ampules/bottles of solution dispensed.

Refer to the Supplier Manual for more information on documentation requirements.

Appendices

PIM citations above denote references to CMS Program Integrity Manual, Internet Only Manual
100-8

Utilization Guidelines

Refer to Coverage Indications, Limitations and/or Medical Necessity

Sources of Information and Basis for Decision

Revision History Information
Please note: The Revision History information included in this LCD prior to 1/24/2013
will now display with a Revision History Number of "R1" at the bottom of this table. All
new Revision History information entries completed on or after 1/24/2013 will display
as a row in the Revision History section of the LCD and numbering will begin with
"R2".

Revision Revision
History
History Revision History Explanation Reason(s) for Change
Date
Number Provider
07/01/2013 Education/Guidance
R4 Revision Effective Date: 07/01/2013

COVERAGE INDICATIONS, LIMITATIONS

AND/OR MEDICAL NECESSITY:

Added: Information that item(s) in policy are

subject to ACA 6407 requirements

Revised: Specific ICD-9 diagnosis codes

contained in the narrative are replaced with a

reference to the applicable diagnosis code

tables

POLICY SPECIFIC DOCUMENTATION

REQUIREMENTS:

Added: ACA 6407 information

08/02/2011 R3 Revision Effective Date: 08/02/2011 Revisions Due To
(November 2013 Publication) CPT/HCPCS Code
HCPCS CODES AND MODIFIERS: Changes
Added: HCPCS code A7018

08/02/2011 R2 Revision Effective Date: 08/02/2011 Provider
(March 2013 Publication) Education/Guidance
COVERAGE INDICATIONS, LIMITATIONS
AND/OR MEDICAL NECESSITY:
Revised: Order requirements language to
specify a “detailed written order”
Changed: Word “Patient” to “Beneficiary”
DOCUMENTATION REQUIREMENTS:
(Note: The effective date above is not

Revision Revision
History
History Revision History Explanation Reason(s) for Change
Date
Number

applicable to this section. These revised and

added requirements are existing Medicare

requirements which are now included in the

LCD for easy reference)

Added: Standard Language

08/02/2011 R1 Revision Effective Date: 08/02/2011 Maintenance (annual
INDICATIONS AND LIMITATIONS OF review with new
COVERAGE: changes, formatting,
Revised: Refills information etc.)
DOCUMENTATION SECTION:
Added: Refills documentation information
Deleted: Statement requiring routine
prescription every 12 months.

Revision Effective Date: 02/04/2011

ICD-9 CODES THAT SUPPORT MEDICAL
NECESSITY:
Revised: Diagnosis sets containing A7013 and
A7014 and created separate diagnosis set for
A7013 and A7014
DOCUMENTATION REQUIREMENTS:
Added: Clerical correction to restore prohibition
on “prn” or “as needed” orders

Revision Effective Date: 02/04/2011
INDICATIONS AND LIMITATIONS OF
COVERAGE:
Added: Coverage for treprostinil inhalation
solution
Revised: Coverage of E0574, E0575
Deleted: References to code E0571
HCPCS CODES AND MODIFIERS (Effective
1/1/2011):
Added: J7686
Revised: J7013
Revised: GA modifier
Deleted: E0571
ICD-9 CODES THAT SUPPORT MEDICAL
NECESSITY:
Added: A7013, A7014, A7016, E0574, J7686 to
pulmonary hypertension ICD-9 code
Deleted: Code E0574 from COPD code set
Deleted: Code E0571

Revision Effective Date: 01/01/2010
INDICATIONS AND LIMITATIONS OF
COVERAGE:
Replaced: Q4080 with Q4074 in the Iloprost

Revision Revision
History
History Revision History Explanation Reason(s) for Change
Date
Number

coverage indications.

HCPCS CODES AND MODIFIERS:

Replaced: Q4080 with Q4074

ICD-9 CODES:

Replaced: Q4080 with Q4074 in the ICD-9

requirements.

DOCUMENTATION REQUIREMENTS:

Replaced: Q4080 with Q4074 in the KX, GA

and GZ modifiers requirements.

Revision Effective Date: 12/01/2009
INDICATIONS AND LIMITATIONS OF
COVERAGE:
Added: Language from Program Integrity
Manual on timing of refills and shipping of
supplies/medications.
Revised: Coverage criteria for long-acting
bronchodilators.
HCPCS CODES AND MODIFIERS:
Added: GA and GZ modifiers.
Revised: KX modifier descriptor.
ICD-9 CODES:
Revised: ICD-9 codes that support medical
necessity for J7605, J7606
DOCUMENTATION REQUIREMENTS:
Deleted: KX requirements from J7605 & J7606.
Added: Instructions for use of GA and GZ
modifiers.

Revision Effective Date: 1/01/2009
INDICATIONS AND LIMITATIONS OF
COVERAGE:
Deleted: Least costly alternative statement for
albuterol/ipratropium combination (J7620)
scheduled to become effective November 1,
2008.
Revised: Statement about denial of coverage
when more than one beta-adrenergic agent is
provided.
Added: Maximum amount for
albuterol/ipratropium combination.
Added: Delivery timeframe for shipping of
refills.
HCPCS CODES AND MODIFIERS:
Added: Code J7606 (formoterol fumarate).
Deleted: Code Q4099 (formoterol fumarate).

Revision Effective Date: 07/01/2008
unless otherwise noted (June 2008
Publication)

Revision Revision
History
History Revision History Explanation Reason(s) for Change
Date
Number

INDICATIONS AND LIMITATIONS OF

COVERAGE:

Removed: Least costly alternative statement

for levalbuterol.

Revised: Effective date for implementation of

least costly alternative statement for

albuterol/ipratropium combination (DuoNeb –

J7620).

Removed: Bibliography references to

levalbuterol.

Revision Effective Date: 07/01/2008
(April 2008 Publication)
NATIONAL COVERAGE POLICY:
Added: NCD 200.2
INDICATIONS AND LIMITATIONS OF
COVERAGE:
Substituted: J7611-J7614 for Q4093, Q4094
Added: Q4099 as a new code for formoterol.
Added: Coverage criteria and maximum
covered amount for formoterol.
Added: J7604, J7632, and J7676 to the list of
compounded drugs that are not covered.
Added: Statement about denial if both
formoterol and arformoterol are provided.
Added: Least costly alternative statement for
levalbuterol.
Added: Least costly alternative statement for
unit dose combinations of albuterol and
ipratropium.
Revised: Coverage criteria for arformoterol.
Revised: Statements concerning use of rescue
medication to include use with formoterol.
HCPCS CODES AND MODIFIERS:
Added: J7604, J7605, J7632, J7676 (effective
1/1/08)
Added: J7611, J7612, J7613, J7614, Q4099
(effective 4/1/08)
Revised: J2545, J7608, J7631, J7639, Q4080
(effective 1/1/08)
Deleted: Q4093, Q4094 (effective 1/1/08)
(Note: Codes J7602 and J7603 were effective
1/1/08 – 3/31/08.)
ICD-9 CODES THAT SUPPORT MEDICAL
NECESSITY:
Added: J7605, J7611-J7614, Q4099
Removed: Q4093, Q4094
Added: Covered diagnosis codes for formoterol.
ICD-9 CODES/ DIAGNOSES THAT DO NOT
SUPPORT MEDICAL NECESSITY:

Revision Revision
History
History Revision History Explanation Reason(s) for Change
Date
Number

Added: J7604, J7632, J7676

DOCUMENTATION REQUIREMENTS:

Added: Instructions for use of the KX modifier

with Perforomist (formoterol).

Revised: Instructions for use of the KX modifier

with Brovana (arformoterol).

SOURCES OF INFORMATION/ BASIS FOR

DECISION:

Added: Bibliography

LCD ATTACHMENTS:

Response to Comments – April 2008

03/01/2008 - In accordance with Section 911
of the Medicare Modernization Act, this policy
was transitioned to DME MAC CIGNA
Government Services (18003) LCD L11517
from DME PSC TrustSolutions (77012) LCD
L11517.

Revision Effective Date: 07/01/2007
(June publication)
INDICATIONS AND LIMITATIONS OF
COVERAGE:
Added: Coverage criteria and maximum
covered amount for arformoterol.
Revised: Statement about J7699 to say that it
will be denied when it is used to bill for a
compounded inhalation solution.
Added: Coverage statement and maximum
covered amount for albuterol, levalbuterol, and
metaproterenol when used in addition to
arformoterol.
Substituted: Codes Q4093 and Q4094 for
J7611-J7614.
HCPCS CODES AND MODIFIERS:
Added: Q4093, Q4094
Deleted: J7611, J7612, J7613, J7614
ICD-9 CODES THAT SUPPORT MEDICAL
NECESSITY:
Added: Q4093, Q4094
Deleted: J7611, J7612, J7613, J7614
Added: Covered diagnosis codes for
arformoterol.
ICD-9 CODES/DIAGNOSES THAT DO NOT
SUPPORT MEDICAL NECESSITY:
Removed: J7699 from the list.
DOCUMENTATION REQUIREMENTS:
Added: Instructions for use of the KX modifier
with arformoterol.

Revision Revision
History
History Revision History Explanation Reason(s) for Change
Date
Number

Revision Effective Date: 07/01/2007

(March publication)

INDICATIONS AND LIMITATIONS OF

COVERAGE:

Eliminated: Coverage for atropine,

beclomethasone, betamethasone, bitolterol,

dexamethasone, flunisolide, glycopyrrolate,

isoetharine, terbutaline, triamcinolone, and all

other compounded inhalation solutions.

Changed: ICD-9 code 519.1 to 519.19.

Deleted: The statement concerning providing

information on a claim about the need for a

portable compressor.

Added: Utilization guideline for budesonide.

HCPCS CODES AND MODIFIERS:

(HCPCS code changes were effective

01/01/2007.)

Added: J7607, J7609, J7610, J7615, J7634,

J7640, J7645, J7647, J7650, J7657, J7660,

J7667, J7670, J7685

Revised: J7611, J7612, J7613, J7614, J7620,

J7622, J7624, J7626, J7627, J7628, J7629,

J7635, J7636, J7637, J7638, J7640, J7641,

J7642, J7643, J7644, J7669, J7680, J7681,

J7682, J7683, J7684, Q4080

Removed: J7633, J7648, J7649, J7658, J7659,

J7668

ICD-9 CODES THAT SUPPORT MEDICAL

NECESSITY:

Changed: ICD-9 code 519.1 to 519.19.

Added: 416.0 and 416.8 to covered codes for

A7005.

Removed: J7622, J7624, J7627, J7628, J7629,

J7633, J7635, J7636, J7637, J7638, J7640,

J7641, J7642, J7643, J7648, J7649, J7658,

J7659, J7668, J7680, J7681, J7683, J7684

ICD-9 CODES AND DIAGNOSES THAT DO NOT

SUPPORT MEDICAL NECESSITY:

Added: J7607, J7609, J7610, J7615, J7622,

J7624, J7627, J7628, J7629, J7634, J7635,

J7636, J7637, J7638, J7640, J7641, J7642,

J7643, J7645, J7647, J7650, J7657, J7660,

J7667, J7670, J7680, J7681, J7683, J7684,

J7685, J7699

DOCUMENTATION REQUIREMENTS:

Added: A requirement for a specific statement

on orders for compounded inhalation solutions.

Revision Effective Date: 06/01/2007
In accordance with Section 911 of the Medicare

Revision Revision
History
History Revision History Explanation Reason(s) for Change
Date
Number

Modernization Act of 2003, Virginia and West

Virginia were transitioned from DME PSC

TriCenturion (77011) to DME PSC

TrustSolutions (77012).

03/01/2006 - In accordance with Section 911
of the Medicare Modernization Act of 2003, this
policy was transitioned to DME PSC
TrustSolutions (77012) from DMERC Palmetto
GBA (00885).

Revision Effective Date: 01/01/2006
INDICATIONS AND LIMITATIONS OF
COVERAGE AND MEDICAL NECESSITY:
Inserted new HCPCS Codes A4216,A4218 and
deleted codes J7051 and J7699 where
appropriately.
Added: Coverage statement for code A7007.
Added: A7007 to the related code table for
E0565.
Added: A7007 to usual maximum amount.
Added: Usual maximum amount for A4216 and
A4218.
HCPCS CODES & MODIFIERS:
Added: HCPCS codes A4218, G0333, J7620,
J7627, Q0513, Q0514
Verbiage revision to description of HCPCS
codes A4216, J7626
Deleted: HCPCS codes J7051, J7616, G0371
and G0374.
ICD-9 CODES THAT SUPPORT MEDICAL
NECESSITY:
Added: J7620 and J7627 to the list of codes
requiring ICD-9 code 491.0-508.9, deleted
J7616.
Added: A7007 to the 5th paragraph of HCPCS
codes requiring specific ICD-9 codes.
Added: A4216 and deleted A7051 from the 6th
paragraph of HCPCS codes requiring specific
ICD-9 codes.
DOCUMENTATION REQUIREMENTS:
Revised: E1399 and J7699 documentation
requirements.

Revision Effective Date: 10/01/2005
HCPCS CODES AND MODIFIERS:
Added: K0730 and Q4080 and KX modifier..
INDICATIONS AND LIMITATIONS OF
COVERAGE AND/OR MEDICAL NECESSITY:
Added: Criterion for K0730 and Q4080.

Revision Revision
History
History Revision History Explanation Reason(s) for Change
Date
Number

ICD-9 CODES THAT SUPPORT MEDICAL

NECESSITY:

Added: Diagnoses codes 416.0, 416.8,

necessary for codes K0730 and Q4080.

DOCUMENTATION REQUIREMENTS:

Added: KX modifier requirement for K0730 and

Q4080.

Revision Effective Date: 04/01/2005
LMRP converted to LCD and Policy Article.
HCPCS CODES AND MODIFIERS:
Added: J7611, J7612, J7613, J7614, J7616,
G0371, G0374
Deleted: J7618, J7619, J7621, E0590
INDICATIONS AND LIMITATIONS OF MEDICAL
NECESSITY:
Tobramycin coverage expanded.

Revision Effective Date: 04/01/2004
HCPCS CODES AND MODIFIERS:
Added: A4217, A7525, J7621
Deleted: A4621, A7019, A7020
INDICATIONS AND LIMITATIONS:
Added: References to new HCPCS codes.
CODING GUIDELINES:
Added: References to new HCPCS codes.
Clarified: Use of J7699.
Added: Billing guidelines for J7621.
Removed: Billing guidelines for A4323.
Added: Correct coding guidelines for
compounded albuterol and ipratropium.
Added: Instructions for billing metered dose
sterile saline products.

Revision Effective Date: 04/01/2003
HCPCS CODES AND MODIFIERS:
Added: EY modifier, J7633
Revised: E0574, J7626
INDICATIONS AND LIMITATIONS OF
COVERAGE:
Added: Standard language concerning
coverage of items without an order.
Added: Standard language concerning the
medical necessity for use of a greater quantity
and combinations of usually contraindicated
drugs requirement.
Removed: Language about physician
documenting having considered use of an MDI
prior to prescribing a nebulizer. Added
pneumocystosis and complications of organ

Revision Revision
History
History Revision History Explanation Reason(s) for Change
Date
Number

transplants as coverage criteria for E0565 or

E0572 compressor used with filtered nebulizer

(A7006).

Removed: Specific coverage criteria for

dornase alpha, other than its being used for

treatment of cystic fibrosis. Removed

grandfathering language for aerosol

compressors and small and large volume

ultrasonic generators.

CODING GUIDELINES:

Added: Instructions on how to bill J7626 0.5mg

as one unit of service.

Added: Definitions of equipment and

inhalations drugs to this section of policy.

DOCUMENTATION REQUIREMENTS:

Added: Standard language concerning use of

EY modifier for items without an order;

standard language regarding excess quantity

utilization;

Listed specific codes in which extra

documentation should be attached to claim via

hardcopy or narrative field.

The revision dates listed below are the
dates the revisions were published and
not necessarily the effective dates for the
revisions.

04/01/2002 - Expansion of coverage for large
volume
nebulizers with saline or water for use with
Tracheobronchial stents (519.1). Expansion of
indications for use of pentamidine with added
ICD-9 codes. Expansion of indications for use
of mucolytics with added ICD-9 codes. New
HCPCS E codes replace K codes. New HCPCS
codes for inhaled corticosteroids. Revision of
HCPCS code for albuterol to include
levalbuterol and its proper billing unit.

04/01/2000 – Several K codes crosswalked to
A codes or J codes. Added “reasonable and
necessary” language in Coverage and Payment
Rules section. Revised all references of
previous K codes.

06/01/1997 – Removed E0575 information in
Documentation section. K0171 removed from
covered codes for small volume nebulizer in
Coverage and Payment Rules section. K0171 is

Revision Revision
History
History Revision History Explanation Reason(s) for Change
Date
Number

not medically necessary for the administration

of medications other than pentamidine.

03/01/1997 – Refer to article entitled
“Nebulizer Policy Update” in the March 1997
DMERC Advisory for a detailed report of the
revision.

09/06/2010 - This policy was updated by the
ICD-9 2010-2011 Annual Update.

11/21/2010 - For the following CPT/HCPCS
codes either the short description and/or the
long description was changed. Depending on
which description is used in this LCD, there
may not be any change in how the code
displays in the document:
A7013 descriptor was changed in Group 2

08/27/2011 - This policy was updated by the
ICD-9 2011-2012 Annual Update.

Associated Documents
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A24944 - Nebulizers - Policy Article - Effective July 2013

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Local Coverage Article for Nebulizers - Policy Article -
Effective July 2013 (A24944)

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NHIC, Corp. 16003

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Maryland
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Nebulizers - Policy Article - Effective July 2013 New Hampshire
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Article Guidance
Article Text
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES

For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit
category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to
improve the functioning of a malformed body member, and 3) meet all other applicable Medicare
statutory and regulatory requirements. Information provided in this policy article relates to
determinations other than those based on Social Security Act §1862(a)(1)(A) provisions (i.e.
“reasonable and necessary”).

Nebulizers are covered under the Durable Medical Equipment benefit (Social Security Act
§1861(s)(6)). In order for a beneficiary’s equipment to be eligible for reimbursement, the
reasonable and necessary (R&N) requirements set out in the related Local Coverage

Determination must be met. In addition, there are specific statutory payment policy
requirements, discussed below, that also must be met.

A large volume pneumatic nebulizer (E0580) and water or saline (A4217 or A7018) are not
separately payable and should not be separately billed when used for beneficiaries with rented
home oxygen equipment.

If a large volume nebulizer, related compressor/generator, and water or saline are used
predominantly to provide room humidification it will be denied as noncovered.

A prefilled disposable large volume nebulizer (A7008) is noncovered under the DME benefit
because it is a convenience item. An unfilled nebulizer (A7007, A7017, or E0585) filled with
water or saline (A4217 or A7018) by the beneficiary/caregiver is an acceptable alternative.

Kits and concentrates for use in cleaning respiratory equipment will be denied as noncovered.

Aztreonam lysine is an inhalation solution that is indicated for beneficiaries with cystic fibrosis
with chronic Pseudomonas aeruginosa infection. Because it has been determined that the
nebulizer that is FDA-approved for administration of aztreonam lysine is not sufficiently durable
to meet the statutory requirements for coverage under the DME benefit, claims for that
nebulizer, aztreonam lysine inhalation solution and related accessories will be denied as
noncovered (no Medicare benefit).

Drugs that are not administered through DME (e.g. Foradil Aerolizer® and metered-dose
inhalers (MDI’s)) are statutorily non-covered. If the supplier chooses to submit a claim for drugs
not administered through DME, the drug must be billed using code A9270 (noncovered item or
service).

Disposable equipment or equipment in which a major component required for their function is
disposable do not meet the definition of durable medical equipment and must be billed using
code A9270 (noncovered item or service).

DISPENSING FEE:

An initial dispensing fee (G0333) is payable to a pharmacy for the initial 30 day supply of
covered inhalation drug(s) regardless of the number of drugs dispensed, the number of
shipments, or the number of pharmacies used by the beneficiary during that time. This initial
30-day dispensing fee is a once in a lifetime fee and only applies to beneficiaries who are using
inhalation drugs for the first time as a Medicare beneficiary on or after 01/01/2006. If code
G0333 is billed for a 30 day supply of covered inhalation drugs and it is not the initial 30 day
supply (i.e., G0333 has already been billed to Medicare for that beneficiary), the claim will be
denied as incorrect coding. When code G0333 has been billed once in a beneficiary’s lifetime,
subsequent claims for a 30 day dispensing fee must be billed using code Q0513.

Medicare will only pay for one of the following for covered inhalation drugs regardless of the
number of drugs dispensed, the number of shipments, or the number of pharmacies used by the
beneficiary during that time period-an initial dispensing fee (G0333), a 30 day dispensing fee
(Q0513), or a 90 day dispensing fee (Q0514).

For a refill prescription, payment of a dispensing fee will be allowed no sooner than 14 days
before the end of usage for the current 30 day or 90 day period for which a dispensing fee was

previously paid. Medicare will not pay for more than 12 months of dispensing fees per
beneficiary per 12 month period.

If the dispensing fee is billed sooner than the interval specified above, it will be denied as not
separately payable. For example, if a 90 day fee (Q0514) is billed on 1/30/06 and is covered and
there is a subsequent claim for a 30 day fee (Q0513) on 4/20/06, the dispensing fee on 4/20/06
will be denied as not separately payable.

Both a Q0513 and a Q0514 dispensing fee are not covered on the same date of service. If a
supplier dispenses a 90 day supply of one drug and a 30 day supply of another drug on the
same day, code Q0514 (90 day fee) must be billed.

The dispensing fee must be billed on the same claim as the inhalation drug(s). If it is not, it will
be denied as incorrect billing.

A dispensing fee is not separately billable or payable for saline, whether used as a diluent or for
humidification therapy.

Medicare will not pay for a separate fee for the compounding of inhalation drug(s).

AFFORDABLE CARE ACT (ACA) 6407 REQUIREMENTS

ACA 6407 contains provisions that are applicable to specified items in this policy. In this policy
the specified items are:

E0570 NEBULIZER, WITH COMPRESSOR

E0575 NEBULIZER, ULTRASONIC, LARGE VOLUME

E0580 NEBULIZER, DURABLE, GLASS OR AUTOCLAVABLE PLASTIC, BOTTLE TYPE, FOR USE
WITH REGULATOR OR FLOWMETER

E0585 NEBULIZER, WITH COMPRESSOR AND HEATER

K0730 CONTROLLED DOSE INHALATION DRUG DELIVERY SYSTEM

Face-to-Face Visit Requirements:

As a condition for payment, Section 6407 of the Affordable Care Act (ACA) requires that a
physician (MD, DO or DPM), physician assistant (PA), nurse practitioner (NP) or clinical nurse
specialist (CNS) has had a face-to-face examination with a beneficiary that meets all of the
following requirements:

• The treating physician must have an in-person examination with the beneficiary within the
six (6) months prior to the date of the WOPD.

• This examination must document that the beneficiary was evaluated and/or treated for a
condition that supports the need for the item(s) of DME ordered.

A new face-to-face examination is required each time a new prescription for one of the specified
items is ordered. A new prescription is required by Medicare:

• For all claims for purchases or initial rentals.
• When there is a change in the prescription for the accessory, supply, drug, etc.
• If a local coverage determination (LCD) requires periodic prescription renewal (i.e., policy

requires a new prescription on a scheduled or periodic basis)
• When an item is replaced

• When there is a change in the supplier
• When required by state law

The first bullet, “For all claims for purchases or initial rentals”, includes all claims for payment of
purchases and initial rentals for items not originally covered (reimbursed) by Medicare Part B.
Claims for items obtained outside of Medicare Part B, e.g. from another payer prior to Medicare
participation (including Medicare Advantage plans), are considered to be new initial claims for
Medicare payment purposes.

Prescription Requirements:

A WOPD is a standard Medicare Detailed Written Order, which must be completed, including the
prescribing physician’s signature and signature date, and must be in the Durable Medical
Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) supplier’s possession BEFORE the
item is delivered. The WOPD must include all of the items below:

• Beneficiary's name,
• Physician’s Name
• Date of the order and the start date, if start date is different from the date of the order
• Detailed description of the item(s)
• The prescribing practitioner's National Provider Identifier (NPI),
• The signature of the ordering practitioner
• Signature date

For any of the specified items provided on a periodic basis, including drugs, the written order
must include, in addition to the above:

• Item(s) to be dispensed
• Dosage or concentration, if applicable
• Route of Administration, if applicable
• Frequency of use
• Duration of infusion, if applicable
• Quantity to be dispensed
• Number of refills, if applicable

Note that prescriptions for these specified DME items require the National Provider Identifier to
be included on the prescription. Prescriptions for other DMEPOS items do not have this NPI
requirement. Suppliers should pay particular attention to orders that include a mix of items, to
assure that these ACA order requirements are met.

Date and Timing Requirements

There are specific date and timing requirements:
• The date of the face-to-face examination must be on or before the date of the written
order (prescription) and may be no older than 6 months prior to the prescription date.
• The date of the face-to-face examination must be on or before the date of delivery for the
item(s) prescribed.
• The date of the written order must be on or before the date of delivery.
• The DMEPOS supplier must have documentation of both the face-to-face visit and the
completed WOPD in their file prior to the delivery of these items.

A date stamp (or similar) is required which clearly indicates the supplier’s date of receipt of both
the face-to-face record and the completed WOPD with the prescribing physician’s signature and
signature date. It is recommended that both documents be separately date-stamped to avoid
any confusion regarding the receipt date of these documents.

Claim Denial

Claims for the specified items subject to ACA 6407 that do not meet the requirements specified
above will be denied as statutorily noncovered – failed to meet statutory requirements.

If the supplier delivers the item prior to receipt of a written order, it will be denied as statutorily
noncovered. If the written order is not obtained prior to delivery, payment will not be made for
that item even if a written order is subsequently obtained. If a similar item is subsequently
provided by an unrelated supplier who has obtained a written order prior to delivery, it will be
eligible for coverage.

CODING GUIDELINES

EQUIPMENT:

In this policy, nebulization of inhalation solutions is accomplished by two types of devices.
Pneumatic compressor nebulizers achieve nebulization of liquid by means of air flow. Ultrasonic
or electronic nebulizers produce nebulization of liquid by means of a vibrating mechanism.

Code E0565 describes an aerosol compressor, which can be set for pressures above 30 psi at a
flow of 6-8 L/m and is capable of continuous operation.

A nebulizer with compressor (E0570) is an aerosol compressor, which delivers a fixed, low
pressure and is used with a small volume nebulizer. It may be AC-powered, DC-powered or
both.

Code E0571 (Aerosol compressor, battery powered, for use with small volume nebulizer) is
invalid for claim submission to the DME MACs. Claims for E0571 will be rejected as invalid
coding.

A light duty adjustable pressure compressor (E0572) is a pneumatic aerosol compressor which
can be set for pressures above 30 psi at a flow of 6-8 L/m, but is capable only of intermittent
operation.

Code E0574 describes an ultrasonic/electronic generator used with a small volume chamber for
medication delivery. Aerosolization of the inhalation solution occurs in a nebulization chamber by
means of a vibrating mechanism such as (not all inclusive) a vibrating disk, pizo-electric device
or vibrating mesh.

For dates of service on or after April 1, 2011, products coded E0574 must have received coding
verification review from the Pricing, Data Analysis and Coding (PDAC) contractor. The only
products that may be billed using code E0574 are those that are specified in the Product
Classification List on the Pricing, Data Analysis, and Coding (PDAC) contractor web site.

Code E0575 describes a large volume ultrasonic nebulizer system which is used for medication
and humidification delivery, and which is capable of continuous operation.

Code K0730 describes a controlled dose inhalation drug delivery system. Aerosol is delivered in
pulses during the inspiration. The duration of each pulse is adapted according to the breathing
pattern.

ACCESSORIES:

Code A7003, A7005, and A7006 include the lid, jar, baffles, tubing, T-piece and mouthpiece. In
addition, code A7006 includes a filter.

Code A7004 includes only the lid, jar and baffles.

Code A7012 describes a device to collect water condensation, which is placed in line with the
corrugated tubing, used with a large volume nebulizer.

Code A7016 describes the dome and mouthpiece containing the aerosolization mechanism for an
ultrasonic/electronic nebulizer system.

Code E0585 is used when a heavy-duty aerosol compressor (E0565), durable bottle type large
volume nebulizer (A7017), and immersion heater (E1372) are provided at the same time. If all
three items are not provided initially, the separate codes for the components would be used for
billing. Code A7007 or A7017 is billed when an unfilled large volume nebulizer is used with an
E0572 compressor or a separately billed E0565 compressor. Code A7007 or A7017 would not be
separately billed when an E0585 system was also being billed. Code E0580 (Nebulizer, durable,
glass or autoclavable plastic, bottle type, for use with regulator or flow meter) describes the
same piece of equipment as A7017, but should only be billed when this type of nebulizer is used
with a beneficiary-owned oxygen system.

INHALATION DRUGS:

The following instructions apply to claims billed using J codes. When claims are billed in NCPDP
format using NDC numbers, different instructions may apply. Refer to the NCPDP Companion
Document available through the CMS website.

A compounded inhalation solution is one in which the product that is delivered to the beneficiary
is not an FDA-approved preparation. It is produced by a pharmacy that is not an FDA-approved
manufacturer and involves the mixing, combining, or altering of ingredients for an individual
beneficiary. Even if one the ingredients is an FDA-approved product (e.g., an injectable form of
the drug), if that is mixed by the pharmacy with other ingredients, the solution that is dispensed
to the beneficiary is considered to be a compounded product.

There are distinct codes for FDA-approved final products and for compounded final products. The
appropriate code must be used when a claim is submitted.

Codes J2545 (pentamidine), J7608 (acetylcysteine), J7631 (cromolyn), J7639 (dornase alpha)
and Q4074 (iloprost) may only be used for inhalation solutions which are FDA-approved. If
compounded versions of these drugs are provided, they must be billed using code J7699.

There are no FDA-approved final products that are described by the following codes: J7633
(budesonide, concentrate), J7648 (isoetharine, concentrate), J7649 (isoetharine, unit dose),
J7658 (isoproterenol, concentrate), J7659 (isoproterenol, unit dose),and J7668 (metaproterenol,
concentrate). These codes are invalid for claim submission.

Codes J7602 (Albuterol, all formulations including separated isomers, inhalation solution, FDA-
approved final product, non-compounded, administered through DME, concentrated form, per 1
mg (albuterol) or per 0.5 mg (levalbuterol)) and J7603 (Albuterol, all formulations including
separated isomers, inhalation solution, FDA-approved final product, non-compounded,
administered through DME, unit dose, per 1 mg (albuterol) or per 0.5 mg (levalbuterol)) were

effective for claims with dates of service from 1/1/08 – 3/31/08. They are invalid for claim
submission for dates of service on or after 4/1/08.

Unit dose form of an inhalation drug or a combination of drugs is one in which the medication is
dispensed to a beneficiary (1) in a bottle/vial/ampule which contains the dose usually used for a
single inhalation treatment, and (2) in a concentration which is dilute enough that it may be
administered to a beneficiary without adding any separate diluent.

Concentrated form of a drug used for inhalation is one in which the drug is dispensed to a
beneficiary in a concentration which requires that a separate diluent (usually saline) be added to
the nebulizer when the drug is administered to a beneficiary.

The coding of a unit dose form or a concentrated form of an inhalation drug is determined by the
formulation of the drug as it is dispensed to the beneficiary. For example, if a pharmacist takes a
concentrated form of a single inhalation drug (e.g., 0.5% albuterol) and dilutes it to a ready-to-
use concentration (e.g., 0.083% albuterol), which is then dispensed to the beneficiary in a
single-dose bottles/vials/ampules, the inhalation solution is billed as the compounded unit dose
form, not the concentrated form.

When there is a single drug in a unit dose container, the KO modifier is added to the unit dose
form code. (Exception: The KO modifier is not used with code J2545 or Q4074.)

Except for code J7620, when two or more drugs are combined and dispensed to the beneficiary
in the same unit dose container, each of the drugs is billed using its unit dose form code. The KP
modifier is added to only one of the unit dose form codes and the KQ modifier is added to the
other unit dose code(s).

Whenever a unit dose form code is billed, it must have a KO, KP or KQ modifier. (Exception: The
KO, KP and KQ modifiers should not be used with code J7620.) If a unit dose code does not have
one of these modifiers, it will be denied as an invalid code. The KO, KP, and KQ modifiers are not
used with the concentrated form codes.

The only FDA-approved unit dose preparation containing more than one drug is J7620, the
combination of albuterol and ipratropium. Therefore, if the following FDA-approved unit dose
codes are billed with a KP or KQ modifier, they will be rejected as invalid for claim submission:
J2545, J7608, J7613, J7614, J7626, J7631, J7639, J7644, J7669, J7682, and Q4074.

The billing unit of service for inhalation drug codes varies. Suppliers must be sure that they use
the correct billing unit or the code when calculating the number of units of service to enter on
the claim. The following is guidance on a few codes where errors are commonly seen:

• Code J7620 is used for an FDA-approved combination of albuterol and ipratropium which
contains 3.0 mg of albuterol sulfate (which is 2.5 mg of albuterol base) and 0.5 mg of
ipratropium bromide in each unit dose vial. For these products, 1 unit of service of J7620
equals 1 unit dose vial.

• For code J7626 and J7627 (budesonide, unit dose), bill one unit of service for each vial
dispensed, regardless of whether a 0.25 mg vial or a 0.5 mg vial is dispensed.

The concentration of the drug in the dispensed solution can be converted to mg or gm as
follows: A solution with a labeled concentration of 1% has ten (10) mg of drug in each milliliter
(ml) of solution. Therefore, a 0.083% albuterol solution has 0.83 mg of albuterol in each ml of
solution. Since albuterol 0.083% solution typically comes in a 3 ml vial/ampule, each
vial/ampule contains 2.5mg of albuterol (3 X 0.83 equals 2.5). If a pharmacist provides 120
ampules of an FDA-approved inhalation solution of 0.83% albuterol solution each containing 3

ml, the billed units of service would be 300 (2.5 X 120) units of code J7613 (for albuterol, 1 mg
equals 1 unit).

When a compounded unit dose preparation is billed, the diluent must not be billed separately.

The nebulizer used to administer aztreonam lysine must be coded and billed using HCPCS code
A9270, noncovered item or service.

Code A4218 is used for metered dose sterile saline products that are used to dilute the
concentrated form of inhalation drugs.

When a drug is provided in a concentration which is dilute enough that it may be administered to
the beneficiary without adding any separate diluent and is dispensed in a multidose container,
use J7699.

Code J7699 is also used for an inhalation drug which does not have a valid specific code. Claims
for drugs that are incorrectly coded J7699 instead of the appropriate code will be denied for
invalid coding.

Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) contractor for guidance
on the correct coding of these items.

Coding Information

Revision History Information
Please note: The Revision History information included in this Article prior to
6/20/2013 will now display with a Revision History Number of "R1" at the bottom of
this table. All new Revision History information entries completed on or after
6/20/2013 will display as a row in the Revision History section of the Article and
numbering will begin with "R2".

Revision Revision Revision History Explanation
History Date History
Number Revision Effective Date: 07/01/2013
07/01/2013 NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
R3 Added: ACA 6407 requirements

04/01/2013 R2 Revision Effective Date: 04/01/2013 (November 2013
Publication)
NON-MEDICAL NECESSITY COVERAGE & PAYMENT RULES:
Revised: Refill Information

08/02/2011 R1 Revision Effective Date: 08/02/2011
NONMEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Added: Noncoverage statement for drugs not administered through
DME
Added: Noncoverage statement for disposable equipment

Revision Revision Revision History Explanation
History Date History
Number Revision Effective Date: 02/04/2011
NONMEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Added: Preamble language
Revised: Correct coding instructions for code G0333.

Revision Effective Date: 02/04/2011
NONMEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Added: Preamble language
Added: Noncoverage statement for nebulizer used to administer
aztreonam lysine and related accessories
CODING GUIDELINES:
Added: Coding information for nebulizer used to administer
aztreonam lysine inhalation solution and related accessories.
Added: Coding verification review for E0574 ultrasonic nebulizers
(Effective for DOS on or after 4/1/2011)
Added: Code E0571 invalid for DME MAC submission
Revised: Definition of E0570 to include battery-powered aerosol
compressors

Revision Effective Date: 01/01/2010
CODING GUIDELINES:
Replaced: Q4080 with Q4074 in the Inhalation Drug Requirements.
Deleted: J7649 and J7659 from the Inhalation Drug Requirements.

Revision Effective Date: 01/01/2009
CODING GUIDELINES:
Deleted: References to trademarked name DuoNeb.
Revised: Changed SADMERC to PDAC.

Revision Effective Date: 07/01/2008
CODING GUIDELINES:
Added: Effective dates of codes J7602 and J7603.
Deleted: Coding guidelines that are no longer needed due to
HCPCS code changes.
Substituted: J7613 or J7614 for Q4094. (J7613 and J7614 were
effective 4/1/08.)
Deleted: Billing instructions for Brovana.

03/01/2008 - In accordance with Section 911 of the Medicare
Modernization Act, this policy was transitioned to DME MAC NHIC
(16003) Article A24944 from DME PSC TriCenturion (77011) Article
A24944.

Revision Effective Date: 07/01/2007
CODING GUIDELINES:
Added: Billing instructions for Brovana (arformoterol).
Added: Statement that J7611-J7614 are invalid and that Q4093 or
Q4094 should be used.

Revision Revision Revision History Explanation
History Date History
Number 06/01/2007 - In accordance with Section 911 of the Medicare
Modernization Act of 2003, Virginia and West Virginia were
transitioned from DME PSC TriCenturion (77011) to DME PSC
TrustSolutions (77012).

Revision Effective Date: 01/01/2007
CODING GUIDELINES:
Added: Definition of a compounded inhalation solution.
Added: Instructions for use of codes J7525 (pentamidine), J7608
(acetylcysteine), J7631 (cromolyn), J7639 (dornase alpha), and
Q4080 (iloprost).
Listed: Codes J7633, J7648, J7649, J7658, J7659, and J7668 as
invalid for claim submission.
Revised: Billing instructions for KO, KP, and KQ modifiers.

03/01/2006 - In accordance with Section 911 of the Medicare
Modernization Act of 2003, this article was transitioned to DME PSC
TriCenturion (77011) from DMERC Tricenturion (77011).

Revision Effective Date: 01/01/2006
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES
Deleted: A7007 from statement that this code would be denied as
a convenience item.
Replaced: Deleted G0371 and G0374 with new dispensing fee
HCPCS codes Q0513 and Q0514.
Revised: Guidelines for dispensing fees.
CODING GUIDELINES:
Added: A7007 as equipment that would not be used with oxygen.
Deleted: J7616 and replaced with new HCPCS code J7620.
Added: A4118 to replace J7699 for metered dose dispenser of
sterile saline or water.

Revision Effective Date: 10/01/2005
CODING GUIDELINES:
Added: Definition of K0730.
Deleted: KP/KQ modifier instructions for albuterol/ipratropium and
albuterol/cromolyn.
Revised: Instructions regarding dispensing fee.

Revision Effective Date 04/01/2005
LMRP converted to LCD and Policy Article
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES
Added: Coverage statements relating to dispensing fees and
compounding fees.
CODING GUIDELINES:
Added: Statement about claims filed in NCPDP format.
Updated: HCPCS codes.
Added: Guidelines for dispensing fee for 30 and 90 days.

Associated Documents
Related Local Coverage Document(s)
LCD(s)
L11499 - Nebulizers

Related National Coverage Documents

Statutory Requirements URL(s)

Rules and Regulations URL(s)

CMS Manual Explanations URL(s)

Other URL(s)

Public Version(s)
Updated on 03/07/2014 with effective dates 07/01/2013 - N/A
Updated on 11/08/2013 with effective dates 04/01/2013 - 06/30/2013
Updated on 03/14/2013 with effective dates 04/01/2013 - N/A
Updated on 08/19/2011 with effective dates 08/02/2011 - 03/31/2013
Updated on 04/16/2011 with effective dates 02/04/2011 - 08/01/2011
Updated on 12/10/2010 with effective dates 02/04/2011 - N/A
Updated on 01/29/2010 with effective dates 01/01/2010 - 02/03/2011
Updated on 11/25/2008 with effective dates 01/01/2009 - 12/31/2009
Updated on 04/04/2008 with effective dates 07/01/2008 - 12/31/2008

Keywords
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