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DME Drugs And Supplies
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Today’s Presenters
• Charity Bright – Provider Outreach and
Education Consultant
• Stacie McMichel – Provider Outreach and
Education Consultant
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National Government Services, Inc.
Disclaimer
• National Government Services, Inc. has produced this material
as an informational reference for providers furnishing services in
our contract jurisdiction. National Government Services
employees, agents, and staff make no representation, warranty,
or guarantee that this compilation of Medicare information is
error-free and will bear no responsibility or liability for the results
or consequences of the use of this material. Although every
reasonable effort has been made to assure the accuracy of the
information within these pages at the time of publication, the
Medicare Program is constantly changing, and it is the
responsibility of each provider to remain abreast of the Medicare
Program requirements. Any regulations, policies and/or
guidelines cited in this publication are subject to change without
further notice. Current Medicare regulations can be found on the
Centers for Medicare & Medicaid Services (CMS) website at
http://www.cms.gov.
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No Recording
• Attendees/providers are never permitted to
record (tape record or any other method) our
educational events
– This applies to our webinars, teleconferences, live
events, and any other type of National Government
Services educational event
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Acronyms
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ABN – Advance Beneficiary Notice of Noncoverage
ACA – Affordable Care Act
CMN – Certificate of Medical Necessity
CMS – Centers for Medicare & Medicaid Services
CNS – certified nurse specialist
DIF – DME Information Form
DME – durable medical equipment
DME MAC – Durable Medical Equipment Medicare Administrative
Contractor
DMEPOS – durable medical equipment, prosthetics, orthotics
and supplies
ESRD – End Stage Renal Disease
FDA – Federal Drug Administration
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Acronyms
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DO – Doctor of osteopathy
DOS – date of service
DWO – detailed written order
HIV – human immunodeficiency virus
HTN – hypertension
IOM – Internet-Only Manual
LCD – local coverage determination
MD – Doctor of medicine
MDI – metered dose inhaler
NDC – National Drug Code
NP – nurse practitioner
NPI – National Provider Identifier
NSC – National Supplier Clearinghouse
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National Government Services, Inc.
Acronyms
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NTE – note segment
PA – physician assistant
PDAC – Pricing, Data Analysis, and Coding Contractor
PECOS – Provider Enrollment, Chain and Ownership System
PEN – parenteral and enteral nutrition
PMD – power mobility device
POD – proof of delivery
PSC – program safeguard contractor
PTAN – Provider Transaction Access Number
RUL – reasonable useful lifetime
SCIG - Subcutaneous immunoglobulin
UOS – Unit of service
WOPD – written order prior to delivery
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National Government Services, Inc.
Objectives
• To provide an understanding of the coverage
criteria, documentation requirements, and
billing guidelines for DME drugs and supplies.
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National Government Services, Inc.
Agenda
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Program Rules and Regulations
Drugs Administered via DME
Oral Medications
Billing and Coding Guidance
Documentation Errors
Resources
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Program Rules And
Regulations
Program Rules
• CMS IOM Publication 100-02, Chapter 15
• CMS IOM Publication 100-04, Chapter 17
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–
–
Drugs and Biologicals
Meet the definition of drugs and biologicals
Not usually self –administered
Reasonable and necessary for the diagnosis or
treatment of the illness or injury under accepted
standards of medical practice
– Not excluded as noncovered
– FDA has not deemed them to be less than effective
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Supplies And Accessories
• Necessary for the effective use of DME
• Must be put directly into the equipment in order
to achieve therapeutic benefit of the DME
– Drug must be reasonable and necessary for the
treatment of the illness or injury to improve the
functioning of a malformed body member
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Limitations Of Coverage
• Billed by entity dispensing to beneficiary, and
• 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 bill the DME MAC
for DME drugs, oral anticancer and oral
antiemetic drugs
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National Government Services, Inc.
Dispensing Physicians
• May bill the DME MAC for drugs if all of the
following conditions are met:
1. Enrolled as supplier with the NSC, and
2. Dispensing the drug(s) to the Medicare beneficiary,
and
3. Authorized by their state laws
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National Government Services, Inc.
Drugs Administered
Via DME
External Infusion Pump
Covered Pumps
• E0779 – Ambulatory Mechanical Infusion
Pump
– Single infusion cycle of at least 8 hours
• E0780 – Ambulatory Mechanical Infusion
Pump
– Single infusion cycle of less than eight hours
• E0781 – Ambulatory Electrical or Battery
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External Infusion Pump
Covered Pumps
• E0791 – Stationary Electrical Pump
– Single or Multiple Channels
– Larger and typically mounted pole
• E0784 – Ambulatory infusion pump for insulin
– External
• K0455 – Ambulatory electrical infusion pump
– Used for uninterrupted administration of
epoprostenol or trespostrinill
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External Infusion Pumps
• General Coverage
• A DME infusion pump is covered if
– The drug being administered is medically necessary
and
– A durable type of pump is required to safely and
effectively administer the drug
• Only those drugs listed in the policy are
covered
• If the patient owns a pump, the drug and
supplies would be covered, if coverage
criteria are met
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Basic Coverage
I.
II.
III.
IV.
V.
Deferoxamine
Chemotherapy
Morphine
Continuous subcutaneous insulin*
Use of other drugs
I. Anticancer chemotherapy
II. Narcotic analgesics
III. Antifungal or antiviral drugs
IV. Parenteral Inotropic
V. Epoprostenil or tresprostinil
VI. Gallium nitrate
VII. Ziconotide
VIII. Subcutaneous immune globulin
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Subcutaneous Insulin
• Treatment of diabetes mellitus (ICD-9 codes
249.00–250.93) if criterion A or B is met and if
criterion C or D is met:
A. C-peptide testing requirement – must meet criterion 1 or
2 and criterion 3
1. C-peptide level < 110% of the lower limit of normal of the
laboratory's measurement method OR
2. Patients with renal insufficiency and a creatinine clearance
< 50 ml/min, a fasting C-peptide level < 200% of the lower
limit of normal of the laboratory’s measurement method
3. A fasting blood sugar obtained at the same time as the
C-peptide level is < 225 mg/dl
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Subcutaneous Insulin
B. Beta cell autoantibody test is positive, only the
following test would be acceptable:
• Islet Cell Cytoplasmic Autoantibodies (ICA)
• The following tests would not be acceptable
alternatives to justify reimbursement:
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•
•
•
•
Glutamic Acid Decarboxylase Auto Antibodies (GADA)
GAD65 Autoantibodies
ICA512 Autoantibodies
Insulinoma-Associated-2 Autoantibodies (IA-2A)
Insulin Autoantibodies (IAA)
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Subcutaneous Insulin
C. Meets all the following:
• Patient has completed a comprehensive diabetes
education program
• Been on a program of multiple daily injections of insulin
with frequent self-adjustments of insulin dose for at
least six months prior to initiation of the insulin pump
• Documented frequency of glucose self-testing an
average of at least four times per day during the two
months prior to initiation of the insulin pump
• Meets one or more of the following criteria (1–5) while
on the multiple injection regimen:
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Subcutaneous Insulin
1. Glycosylated hemoglobin level (HbA1C) greater than
7 percent
2. History of recurring hypoglycemia
3. Wide fluctuations in blood glucose before mealtime
4. Dawn phenomenon with fasting blood sugars
frequently exceeding 200 mg/dL
5. History of severe glycemic excursions
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Subcutaneous Insulin
D. Patient has been on an external insulin infusion
pump prior to enrollment in Medicare and has
documented frequency of glucose self-testing an
average of at least four times per day during the
month prior to Medicare enrollment
– If criterion A or B or if criterion C or D is not met, the
pump and related accessories, supplies, and insulin
will be denied as not medically necessary
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Subcutaneous Insulin
Continued Coverage
• Patient has been seen and evaluated by the
treating physician at least every six months
• The external insulin infusion pump must be
ordered and follow-up care rendered by a
physician who manages multiple patients on
continuous subcutaneous insulin infusion
therapy
• Subcutaneous insulin is administered using
ambulatory infusion pump E0784, all other
pumps will be denied as not medically
necessary
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National Government Services, Inc.
Subcutaneous Immune Globulin
(J1562, J1559, J1561, J1569)
• SCIG is covered only if criteria 1 and 2 are met
– The SCIG preparation is a pooled plasma derivative
which is approved for the treatment of primary immune
deficiency disease
– Patient has a diagnosis of primary immune deficiency
disease (ICD-9 codes 279.04, 279.05, 279.06,
279.12, 279.2)
• An E0779 infusion pump is covered, if an
E0781 or E0791 pump is used, payment will be
based on the allowance for the least costly
medically appropriate alternative, E0779
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Intravenous Immune Globulin
• An infusion pump is not covered for the
administration of intravenous immune
globulin
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Intravenous Immune Globulin
• Intravenous immune globulin (IVIG) is covered
if all of the following criteria are met:
1. It is an approved pooled plasma derivative for the
treatment of primary immune deficiency disease; and
2. The patient has a diagnosis of primary immune
deficiency disease (ICD-9 codes 279.04, 279.05,
279.06, 279.12, 279.2); and
3. The IVIG is administered in the home; and
4. The treating physician has determined that
administration of the IVIG in the patient’s home is
medically appropriate.
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Not Medically Necessary
• When other drugs (including but not limited to
intravenous antibiotics) are administered
using a DME infusion pump, CMS instruction
is that they should be denied as not medically
necessary
– This is not because the drug itself is not medically
necessary, but because a DME infusion pump is not
medically necessary to administer them
– CMS policy is that if a DME item is denied as not
medically necessary, then accessories, supplies, and
drugs used with the item are also denied as not
medically necessary
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Not Medically Necessary
• Treatment of thromboembolic disease and/or
pulmonary embolism by heparin infusion in
home setting
• An infusion controller device (E1399)
• An IV pole (E0776) billed with an ambulatory
infusion pump (E0779, E0780, E0781,
E0784, or K0455)
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Noncovered
• Disposable drug delivery systems, including
elastomeric infusion pumps (A4305, A4306,
A9274)
– Not meet the Medicare definition of durable medical
equipment
– Drugs and supplies used with disposable drug
delivery systems are also noncovered items
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Supplies – Catheter (A4221)
• Code A4221 includes catheters, cannulas,
needles, infusion sets, catheter insertion
devices, flushing solutions, and any type of
dressing used at the insertion site
• UOS for A4221 is per week
• It is never acceptable to bill > 1 UOS per
week, regardless of the type and/or quantity
of supplies that are dispensed
– Billing for > 1 UOS per week is incorrect coding and
can not be appealed
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National Government Services, Inc.
Supplies – Catheter (A4221)
• Supplies for the maintenance of a parenteral
drug infusion catheter (A4221) are covered
during the period of covered use of an
infusion pump and the weeks in between
covered infusion pump use, not to exceed
four weeks per episode
• Drugs and supplies that are dispensed but
not used for completely unforeseen
circumstances (e.g., emergency admission to
hospital, drug toxicity, etc.) are covered
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Supplies – Bag/Cassette (A4222)
Syringe (K0552)
• Supplies used with an external infusion pump,
A4222 or K0552, are covered during the period
of covered use of an infusion pump
• A4222 is used with pumps E0779, E0780,
E0781, E0791, K0455 (IV
epoprostenol/treprostinil)
• K0552 is used with pumps E0779
(subcutaneous immune globulin), E0784, and
K0455 (subcutaneous treprostinil)
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Supplies – Bag/Cassette (A4221)
Syringe (K0552)
• Allowance is based on the number of
cassettes or bags (A4222) prepared or
syringes (K0552) used
• Intermittent infusions
– One cassette or bag is covered for each dose of drug
• Continuous infusion
– Concentration of the drug, and
– Size of the cassette, bag, or syringe
• Maximize to result in the fewest cassettes, bags, or
syringes
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Supplies/Accessories – Misc.
• Replacement batteries (K0601–K0605) are
not separately payable when billed with a
rented infusion pump
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National Government Services, Inc.
Common Errors
• Orders
– ACA requirements
– Incomplete or missing
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•
•
•
Request for refill for DME drugs
Proof of delivery for Method 2
Continued Use
Continued Need
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National Government Services, Inc.
Nebulizers
Coverage Criteria
• Small volume nebulizer (A7003, A7004,
A7005), related compressor (E0570), and
FDA-approved inhalation solutions of the
drugs are covered for the management of the
covered medical conditions
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Drug Classes
Beta agonists:
• Short-acting beta agonists (SABA)
• Long-acting beta agonists (LABA)
Albuterol, levalbuterol, metaproterenol
Arformoterol, formoterol
Anticholinergic
Ipratropium
Combination drugs
Albuterol and ipratropium
Corticosteroid
Budesonide
Mucolytic – nonspecific
Acetylcysteine
Anti-inflammatory
Cromolyn (almost exclusive for asthma)
Mucolytic enzyme
Dornase alpha
Antibiotic
Tobramycin
Anti-HIV drug
Pentamidine
Pulmonary artery vasodilator
Iloprost
Treprostinil
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Coverage Criteria
• Small volume ultrasonic nebulizer (E0574)
– Reasonable and necessary to administer treprostinil
inhalation solution only
– E0574 used with other inhalation solutions will be
denied as not reasonable and necessary
• Large volume ultrasonic nebulizer (E0575)
– Will be denied as not medically necessary
– Any related accessories and supplies will also
be denied
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Not Medically Necessary
• 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,
– Compounded solutions billed with J7699
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Modifiers
• KO – Single drug unit dose formulation
– Not used with J2545 and Q4074
• KP – First drug of a multiple drug unit dose
formulation
• KQ – Second or subsequent drug of a multiple
drug unit dose formulation
• If a unit dose does not have one of these modifiers
(with the exception of J7620), it will be denied as
an invalid code
• The KO, KP, and KQ modifiers are not to be used
with the concentrated form codes
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KX, GA, GZ
Modifier Requirement
• HCPCS codes E0574, J7686, K0730 and
Q4074 only:
• Append KX modifier only if:
– Requirements specified in the medical policy have
been met
• When policy criteria are not met:
– Execute ABN
– Append GA modifier
– If ABN is not executed, append GZ modifier
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Billing E1399 And J7699
• HCPCS E1399 billed for miscellaneous
equipment or accessories
– Claim must be accompanied by a clear description of the
item including the manufacturer and the model
name/number if applicable
• HCPCS J7699 for miscellaneous inhalation
drugs
– Include the name of the drug, the manufacturer, the NDC
number, the dosage amount (i.e., 50 mg) and the number
ampules/bottles dispensed
• Report in NTE segment of electronic claim or
Item 19 of CMS-1500 paper claim
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Dispensing Fee
• G0333 – Initial dispensing fee
– Once in a lifetime fee for the first time as a Medicare
beneficiary on or after 01/01/2006
• Q0513 – 30 day dispensing fee
• Q0514 – 90 day dispensing fee
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Allowances
Drug Name
HCPCS
Unit of Service
(UOS)
Maximum/
Month
Maximum
UOS/Month
Acetylcysteine
J7608
Per 1 gram
74 grams/month
74
Albuterol
J7611, J7613
Per 1 mg
465 mg/month**
465
Albuterol/Ipratropium combination
J7620
Up to 2.5 mg albuterol and 0.5
mg of ipratropium – 3.0mg total
– 1 vial
558 mg total/month –
186 vials**
186
Arformoterol
J7605
15 mcg
930 mcg/month
62
Budesonide
J7626
Up to 0.5 mg – 1 vial
31 mg/month
62
Cromolyn sodium
J7631
Per 10 mg
2480 mg/month
248
Dornase alpha
J7639
Per 1 mg
78 mg/month
78
Formoterol
J7606
20 mcg
1240 mcg/month
62
Ipratropium bromide
J7644
Per 1 mg
93 mg/month
93
Levalbuterol
J7612, J7614
Per 0.5 mg
232.5 mg/month**
465
Metaproterenol
J7669
Per 10 mg
2800 mg/month**
280
Pentamidine
J2545
Per 300 mg
300 mg/month
1
Treprostinil
J7686
1.74 mg – 1 ampule/vial
31 ampules/vials month
31
Sterile saline or water
A4216, A4218
10 ml – 1 unit
560 ml/month
56
Distilled water, sterile water, or sterile
saline in large volume nebulizer
A4217, A7018
500 ml
18,000 ml – 18
liters/month
36
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Allowances
• When albuterol, levalbuterol, or metaproterenol are
prescribed as rescue/supplemental medication for patients
who are taking formoterol or arformoterol, the maximum
milligrams/month that are reasonably billed are:
Drug Name
HCPCS
Unit of
Service (UOS)
Maximum/
Month
Maximum
UOS/Month
Albuterol
J7611, J7613
1 mg
78 mg/month
78
Albuterol/Ipratropium
combination
J7620
Up to 2.5 mg albuterol
and 0.5 mg of
ipratropium – 3.0 mg
total – 1 vial
93 mg/month – 31
vials
31
Levalbuterol
J7612, J7614
0.5 mg
39 mg/month
78
Metaproterenol
J7669
Per 10 mg
470 mg/month
47
• Claims for more than these amounts will be denied as not
medically necessary
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Accessories
• Table lists the compressor/generator, which
is related to the accessories described
• Other compressor/generator/accessory
combinations are considered medically
unnecessary
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
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Accessories
Accessory
Usual Maximum Replacement
A4619
One/month
A7003
Two/month
A7004
Two/month (in addition to A7003)
A7005
One/6 months
A7005
One/3 months only with K0730
A7006
One/month
A7007
Two/month
A7010
One unit (100 ft.)/2 months
A7011
One/year
A7012
Two/month
A7013
Two/month
A7014
One/3 months
A7015
One/month
A7016
Two/year
A7017
One/3 years
A7525
One/month
E1372
One/3years
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HCPCS A9270
• Drugs that are not administered through DME
(e.g., Foradil Aerolizer® and MDIs) are
statutorily noncovered
• 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
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Common Errors
• Orders
– ACA requirements
– Incomplete or missing
• Continued use
• Continued need
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Oral Medication
Immunosuppressive Drugs
Coverage Criteria
1. Following an organ transplant:
•
•
•
•
•
•
•
V42.0 Kidney
V42.1 Heart
V42.6 Lung
V42.7 Liver
V42.81 Bone Marrow
V42.82 Peripheral Stem Cells
V42.83 Pancreas (for diabetes)
– Whole organ (V42.83), partial (V42.89) organ, islet cell
(V42.89)
• V42.84 Intestines
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Immunosuppressive Drugs
Coverage Criteria
2. Criteria for the transplant met:
–
–
–
–
Approved facility
NCD criteria
LCD criteria
Carrier/fiscal intermediary LCD criteria
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Immunosuppressive Drugs
Coverage Criteria
3. Medicare Part A enrolled during eligible
transplant:
– Medicare paid for transplant, or
– Other primary insurance paid
4. Enrolled in Medicare Part B when drugs
dispensed
5. Drugs furnished on or after the date of
discharge from the hospital
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Specified Coverage
• Parenteral azathioprine (J7501) or
Methylprednisolone (J2920, J2930)
– Medication not tolerated or absorbed if taken
orally, and
– Self-administered by the patient
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Not Medically Necessary
• Parenteral cyclosporine (J7516),
Antithymocyte globulin (J7504, J7511),
Muromonab-CD3 (J7505), Tacrolimus
(J7525), and Daclizumab (J7513) are not
proven safe when
– Administered in the home setting, and
– Therefore will be denied not medically necessary
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Modifiers
• EY – No physician or other licensed health
care provider order for this item or service
• GY – Item or service statutorily excluded
or does not meet the definition of any
Medicare benefit
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KX Modifier
• Beneficiary enrolled in Medicare Part A at the
time of transplant
• Documentation regarding the beneficiary’s
transplant date are on file, and
• The beneficiary’s transplant date precedes
the DOS for furnishing the drug
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Supply Fee
• Q0510 – First month of initial
immunosuppressive drug following transplant
• Q0511 – First prescription in a 30-day period
• Q0512 – Subsequent prescription in a 30-day
period
If drug on claim is denied as noncovered, the
supply fee will be denied as noncovered
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Billing
• Supply fee must be billed on the same claim
as the drug
• Quantity of drugs dispensed should be limited
to a 30-day supply
• Bill a separate claim line if two different
dosage strengths of the same drug are
dispensed
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Billing
• J7599 NOC immunosuppressive drugs
require the following information in the NTE
segment field:
–
–
–
–
Name of the drug,
Dosage strength,
Number dispensed, and
Administration instructions
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Other Points To Remember
• Number of units billed must accurately reflect
the definition of one unit of service
• ICD-9 code(s) that justify the need must be
included on the claim
• Coverage is limited to 36 months for
beneficiaries whose Medicare entitlement is
based solely on ESRD
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Common Errors
• Medical need documentation
• Continued use
• Continued need
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Oral Anticancer Drugs
Oral Anticancer Drug Coverage
• An oral anticancer drug is covered if all of the
following criteria (1–4) are met:
1. FDA approved
2. Has the same ingredients as the comparable IV
chemotherapeutic drug or biological that is covered
when furnished incident to a physician's service
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Oral Anticancer Drug Coverage
• Covered Oral Anticancer Drugs
–
–
–
–
–
–
–
–
Busulfan
Capecitabine
Cyclophosphamide
Etoposide
Melphalan
Methotrexate
Temozolomide
Topotecan
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Oral Anticancer Drug Coverage
3. Used for the same indications, including unlabeled
uses, as the non-self-administrable form of the drug
• All drugs except topotecan, prescribed for the treatment
of cancer (ICD-9 codes 140.0–208.91, 230.0–239.9,
259.2, 273.3, V58.11)
• For topotecan, prescribed for the treatment of relapsed
small cell lung (ICD-9 codes 162.2–162.9)
4. Prescribed by a physician or other practitioner
licensed under state law
If criterion 1–4 are not met, the drug will be denied as
noncovered
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Covered Diagnosis
• The ICD-9 diagnosis code describing the
condition for which the drug is used must be
included on each claim
Drug Name
ICD-9 or Corresponding
Covered Diagnosis Codes
Topotecan
162.2-162.9
Busulfan, Capecitabine,
Cyclophosphamide, Etoposide,
Melphalan, Methotrexate, and
Temozolomide
140.0-208.91, 230.0-239.9, 259.2,
273.3, V58.11
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HCPCS J8999
• HCPCS code J8999 should only be used if the
oral anticancer drug 11-digit NDC number is not
yet in the DME MAC claims processing system
– Currently the only drug that should be billed using the
J8999 is topotecan
• Claims using code J8999 must include the
name of the drug, the manufacturer, the NDC
number, and the number of tablets or capsules
dispensed
– Enter in the NTE segment of an electronic claim or Item 19
for paper submission
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Concurrent Antiemetic
Drugs Coverage
• A self-administered antiemetic drug billed
with code J8498 or J8597 is covered if all of
the following criteria are met
1. Used in conjunction with a covered oral anticancer
drug, and
2. Administration of the covered oral anticancer drug
will likely induce emesis if the antiemetic drug is not
administered, and
3. Administered within two hours before the covered
oral anticancer drug is administered
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Concurrent Antiemetic
Drugs Coverage
• If all of the criteria are not met, the antiemetic
drug will be denied as noncovered
• Doses of antiemetic drugs administered after the
administration of the oral anticancer drug are
noncovered
• Coverage of oral antiemetic drugs (replacement
for intravenous antiemetics) used in conjunction
with intravenous cancer chemotherapeutic
regimens, refer to the oral antiemetic drugs
(replacement for intravenous antiemetics) policy)
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Noncovered Drugs
• Drugs which are not covered under the oral
anticancer drug benefit (i.e., those that are
not specifically listed in this policy) must be
billed using code A9270 (noncovered item or
service) if the supplier chooses to submit a
claim
• Contact the PDAC contractor for guidance on
the correct coding of these items
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Supply Fee
• Q0511 – First covered oral anticancer drug
dispensed in a 30-day period
• Q0512 – Each subsequent covered oral
anticancer drug dispensed in a 30-day period
If drug on claim is denied as noncovered, the
supply fee will be denied as noncovered
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Billing
• Supply fee must be billed on the same claim
as the drug
• Quantity of drugs dispensed should be limited
to a 30-day supply
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Oral Anticancer Drug Billing
• Suppliers must use the 11-digit NDC that
matches the product dispensed
– 1 unit of service = 1 tablet or 1 capsule
• A list of valid NDC numbers for covered
oral anticancer drugs can be found on the
PDAC website http://www.dmepdac.com
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Concurrent Antiemetic
Drugs Billing
• J8498 (Rectal/Suppository) or J8597 (Oral)
• Must identify
–
–
–
–
–
Drug Name
Manufacturer
Dosage strength (each tablet/suppository)
Frequency of administration, and
The concurrent oral anticancer drug being used
• Enter in the NTE segment of an electronic claim
or Item 19 for paper submission
• Do NOT enter corresponding oral antiemetic
drug NDC number
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Common Errors
• Medical need documentation
• Proof of delivery for Method 2
• Request for refill
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Oral Anti-Emetic Drugs
Oral Antiemetic Drug
Coverage Criteria
1. FDA approved
2. Ordered by the treating physician as part of
a cancer chemotherapy regimen
3. Used as a full therapeutic replacement for
an intravenous antiemetic drug prior to IV
chemotherapy
4. Initial dose of the oral antiemetic drug is
administered within two hours before or 48
hours after the administration of the
chemotherapy drug
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Covered Diagnosis
• The ICD-9 diagnosis code describing the
condition for which the drug is used must be
included on each claim
ICD-9 Code
Corresponding Diagnosis Definition
140.0-208.91
230.0-239.9
273.3
V58.0-V58.12
Malignant neoplasm
Carcinoma in situ
Macroglobulinemia
Radiotherapy chemotherapy
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Oral Antiemetic
Drug Coverage
• If all the criteria (1–4) are met, the quantity
covered for each episode of chemotherapy
cannot exceed the initial loading dose plus 48
hours of therapy
– For granisetron (Q0166) and dolasetron (Q0180), the
quantity covered for each episode of chemotherapy is
limited to the initial loading dose plus 24 hours of
therapy
• Quantities of drugs in excess of these
amounts are noncovered
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Aprepitant (J8501) and
Dexamethasone (J8540)
• Are covered only if
– Criterion 1-4 are met, and
– Administered as part of an oral antiemetic three-drug
regimen
• Including a 5-HT3 antagonist
– Granisetron (Q0166), ondansetron (Q0179), or dolasetron
(Q0180)
• The oral antiemetic three-drug combination
should be submitted on the same claim
• If not used as part of this three-drug regimen,
the drugs will be denied as noncovered
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Aprepitant (J8501) and
Dexamethasone (J8540)
• Covered when administered to patients who
are receiving one or more of the following
anti-cancer chemotherapeutic agents
–
–
–
–
–
−
−
−
−
Carmustine
Cisplatin
Cyclophosphamide
Dacarbazine
Mechlorethamine
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Streptozocin
Doxorubicin
Epirubicin
Lomustine
National Government Services, Inc.
HCPCS Q0181
• HCPCS code Q0181 should only be used if the
oral antiemetic drug provided does not have a
specified HCPCS code
• Claims using code Q0181 must include
–
–
–
–
–
Drug Name
Manufacturer
Dosage strength dispensed
Number of tablets, and
Frequency of administration during the covered time period
(24-48 hours) as specified on the order
• Enter in the NTE segment of an electronic claim or
Item 19 for paper submission
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Supply Fee
• Q0511 − First covered oral antiemetic drug
dispensed in a 30-day period
• Q0512 − Each subsequent covered oral
antiemetic drug dispensed in a 30-day period
If drug on claim is denied as noncovered, the
supply fee will be denied as noncovered
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Modifiers
• EY − Items billed before a signed and dated
order has been received by the supplier must be
submitted with an EY modifier added to each
affected HCPCS code
• KX − If aprepitant (J8501) and dexamethasone
(J8540) are used in conjunction with one of the
covered anticancer chemotherapeutic agents, a
KX modifier should be added to each code
– Should be billed with one of the following to be covered as
part of the three-drug regimen; granisetron (Q0166),
ondansetron (Q0179), or dolasetron (Q0180)
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Common Errors
•
•
•
•
Orders
Medical need documentation
Continued use
Continued need
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Questions
Resources
• Centers for Medicare & Medicaid Services
http://www.cms.gov
• National Government Services website
http://www.NGSMedicare.com
•
•
•
•
Local Medical Policies
Dear Physician Letters
Policy Education Page
Tools and Materials Page
• IVR 877-299-7900
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Resources
• Customer Care Contact Center
866-590-6727
• Connex http://www.NGSConnex.com
• Medicare University
http://www.MedicareUniversity.com
• Self-Service Tools
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E-mail Updates
• Subscribe to receive the latest, up-to-date
Medicare information.
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Website Survey
• This is your chance to have your voice
heard—Say “yes” when you see this pop-up
so National Government Services can make
your job easier!
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Medicare University
• http://www.MedicareUniversity.com
• Interactive online system available 24/7
• Educational opportunities available
– Computer-based training courses
– Teleconferences, webinars, live seminars/face-to-face
training
• Self-report attendance
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Medicare University
Self-Reporting Instructions
• Log on to the National Government Services
Medicare University site at
http://www.MedicareUniversity.com
– Topic = 2014 Jurisdiction B Medicare Seminars
– Medicare University Credits (MUCs) = 8
– Catalog Number and Course Code = To Be Given
During Live Presentation
– For step-by-step instructions on self-reporting please
visit the Accessing the Self-Reporting Tool page on
the NGSMedicare.com website
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Thank You!
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