Medical Oncology Services

Part B Provider Outreach and Education

January 2018
 DISCLAIMER
This information release is the property of Noridian Healthcare Solutions, LLC. It may be
freely distributed in its entirety but may not be modified, sold for profit or used in
commercial documents.
The information is provided “as is” without any expressed or implied warranty. While all
information in this document is believed to be correct at the time of writing, this
document is for educational purposes only and does not purport to provide legal advice.
All models, methodologies and guidelines are undergoing continuous improvement and
modification by Noridian and CMS. The most current edition of the information
contained in this release can be found on the Noridian website at
https://med.noridianmedicare.com/ and the CMS website at https://www.cms.gov
The identification of an organization or product in this information does not imply any
form of endorsement.
CPT codes, descriptors, and other data only are copyright 2018 American Medical
Association. All rights reserved. Applicable FARS/DFARS apply.

January 2018 2
 Agenda
• Overview
• Drugs and Biologicals
• Evaluation and Management Services
• Administration
• Minimize Common Errors
– CERT Reminders
• Resources

January 2018 3
 Helpful Acronyms
http://www.cms.gov/apps/acronyms
ACRONYM DESCRIPTION
ABN Advance Beneficiary Notice of Non Coverage
ESA Erythropoiesis Stimulating Agents
IOM Internet Only Manual
MLN Medicare Learning Network
MPFS Medicare Physician Fee Schedule
MUE Medically Unlikely Edits
NCCI National Correct Coding Initiative
OCM Oncology Care Model
SADs Self-Administered Drugs

January 2018 4
Overview
 Medical Necessity
• Document medical necessity within medical
records
– Authenticated medical records
• Records must provide clear evidence of the
need for treatments
– Ongoing significant benefit
– Objective measurements
• Complexity of skill required by treating
practitioner must be clear

January 2018 6
 125
Oncologist Role
• Treatment
• Counseling
– Diagnosis
– Disease dynamics
– Treatment options
– Recommended course of treatment

January 2018 7
 Oncology Disciplines
• Surgical oncology
• Radiation oncology
• Medical oncology

January 2018 8
 Medical Oncology
Drugs and Biologicals
 Office Chemotherapy Charges
• Cost of drug(s)
– Incident to guidelines
• Administration cost
• Other covered services

January 2018 10
 Providing Drugs
“Incident To” Provision

• May not instruct patients to purchase drugs then

bring to provider’s office for administration

• Drug charge included in physician’s bill and cost

represents expense to physician

January 2018 11
 Donated or Free of Charge
Patient Supplied Drug
• To avoid drug administration denial, drug code
must be on same or prior claim
• Include the following information:
Item Description
19 “Drug Donated” with description, strength and
(Narrative) dosage when billing Not Otherwise Classified
(NOC) HCPCS
24D Drug (J code) HCPCS
28 Billed amount of $0.00 or $0.01

January 2018 12
 127
Medicare Drug Benefit
• Not self administered
• Incident to physician service
• Reasonable and necessary
• Not excluded
• FDA approved

January 2018 13
 Medicare Drug Pricing
• 106% of the Average Sales Price (ASP)
• Updated quarterly

January 2018 14
 Top Adjudication Issues
• Unlisted codes or NOC
• J3490, J9999, and J3590
– Name of the drug and dosage
– Item 19
– Electronic equivalent
• Bill the correct number of units
• Claims not providing adequate information deny
unprocessable

January 2018 15
 129
Unlabeled Use for Anti-Cancer Drugs
• Use not included as an indication on drug’s label
as approved by the FDA
• May be covered if contractor determines to be
medically accepted
• Consideration include:
– Major drug compendia
– Authoritative medical literature
– Accepted standards of medical practice

January 2018 16
 Off-Label Use in
Anti-Cancer Regimen
• Regimen is a combination of anti-cancer agents
clinically recognized to treat specific cancers
• Supported in compendia or peer-reviewed
medical literature
– Contractor may maintain its own subscriptions for
consideration
– Contractor may request literature supporting off-label
use from the physician

January 2018 17
 1
ESA for Cancer Patients
• Stimulate formation of new red blood cells
• Decrease anemia
• Decrease need for transfusions
• Epoetin Alfa – anemia in patients on
chemotherapy
• Darbepoetin Alfa - anemia due to effects of
chemotherapy in patient with non-myeloid
malignancies

January 2018 18
 ESA Medical Record Documentation
• ICD-10 code alone does not assure coverage
• Medical records must be available, legible,
signed, and include:
– Patient’s weight in kilograms or pounds
– Erythropoietin analog units administered per kilogram
of body weight
– Medical justification for administration of
erythropoietin analogs exceeding usual doses

January 2018 19
 133
Billing Erythropoietin (EPO)
• J0881 = Darbepoetin alfa
• J0885 = Epoetin Alfa
• ICD-10: Review Local Coverage Determinations:
• LCD Retired 01/01/2018
– JE: L34167
– JF: L34107
• NCD 110.21

January 2018 20
 Required Reporting of the
Hematocrit or Hemoglobin Reading
• Administration of an ESA
– J0881, J0882, J0885, J0886 and Q4081
• Administration of Part B anti-anemia drug
• Test Readings in Loop 2400 MEA01 segment
– Hemoglobin: MEA02=R1
– Hematocrit: MEA02=R2
– Test results: MEA03 (3 digit plus decimal point
numeric test result)
• Examples: 2400/MEA/TR/R1/27.5

January 2018 21
 Most Recent Numeric Test Results
• Report as three numbers
• Decimal point between second and third number
– Must be submitted as part of the value
– Examples:
• 4.5 must show 04.5
• 28 must show 28.0
• .9 must show 00.9

January 2018 22
 Medical Oncology &
Evaluation & Management
Services
 Established Patient 99212-99215
• Office or other outpatient visit for E/M of an
established patient
– History
– Exam
– Decision making
• Levels depend on problems presented
– Records should tell a complete story of the patients
condition

January 2018 24
 1
E/M Code Based on Time
• More than 50% of time
– Counseling
– Coordination of care
• Select code level by time
• Medical record
– Note counseling time
– Note total time of visit

January 2018 25
 Medical Record

• Document
– Diagnosis
– Prognosis
– Treatment options
– Treatment plan
– Side effects
– Recovery
– Signature

January 2018 26
Administration Coding
 Administration Services
• Hydration
• Therapeutic, prophylactic, and diagnostic
injections and infusions (excluding
chemotherapy)
• Chemotherapy administration

January 2018 28
Administration Coding

Hydration
 Hydration
• 96360 Infusion, initial, up to 1 hour
– Minimum time duration of 31 minutes is required to
report
• 96361 each additional hour
– List separately in addition to primary service
– Hydration provided secondary or subsequent to initial
service
• Use 96361
• With 96360, 96365, 96374, 96409, 96413

January 2018 30
 Hydration Time Billing

Total Time of Hydration

Billing Example
Infusion
31 – 90 minutes 96360 only

91 – 150 minutes 96360 x 1 and 96361 x 1

151 – 210 minutes 96360 x 1 plus 96361 x 2

211 – 270 minutes 96360 x 1 plus 96361 x 3

January 2018 31
 Medical Documentation
• Medical necessity for hydration supported by
provider involved in clinical assessment
– Usually on the same day
– Describe symptoms warranting hydration
• Dehydration
• Inability to ingest fluids
• Abnormal fluid losses
• Abnormal vital signs
• Abnormal labs
• Nausea itself does not implicate fluid volume depletion

January 2018 32
 Administration Coding

Therapeutic, prophylactic diagnostic

injections and infusions
(excluding chemotherapy)
 Infusion Codes
Other than Chemotherapy
CPT Code Code Description
96365 IV infusion, initial, up to 1 hour
96366 Each additional hour
• List with primary code 96365 or 96367
• For > 30 minutes beyond 1 hour
96367 Additional sequential infusion, ≧ 1 hour

96368 Concurrent infusion

• List with primary code
• 96365, 96366, 96374, 96413, 96415,
96416, 96422, 96423
• Report only once per date of service
January 2018 34
 Infusion Codes
Other than Chemotherapy
CPT Code Code Description
96372 Injection, subcutaneous or intramuscular

96373 Intra-arterial

96374 IV push, single/initial drug

96375 Each additional IV push, new drug

• List with primary code (96365, 96374,
96409, 96413)

January 2018 35
 Included in Administration
• Local anesthesia
• IV start
• Access to indwelling IV, subcutaneous catheter,
or port
• Flush at conclusion of infusion
• Standard tubing, syringes and supplies

January 2018 36
 E/M and
Injections/Infusions
• Modifier 25 on E/M code with
– 96360 – 96361
– 96365 – 96379
• Significant identifiable problem
– Clearly document

January 2018 37
Administration Coding

Chemotherapy Administration
CPT Code Code Description
96401 Chemotherapy administration, subcutaneous or intramuscular; non-hormonal anti-
neoplastic
96402 Chemotherapy administration, subcutaneous or intramuscular; hormonal anti-
neoplastic
96405 Chemotherapy administration; intralesional, up to and including 7 lesions
96406 Chemotherapy administration; intralesional, more than 7 lesions
96409 Chemotherapy administration; intravenous, push technique, single or initial
substance/drug
96411 Chemotherapy administration; intravenous, push technique, each additional
substance/drug (list separately in addition to code for primary procedure)
96413 Chemotherapy administration, intravenous infusion technique; up to 1 hour, single
or initial substance/drug
96415 Chemotherapy administration, intravenous infusion technique; each additional
hour (list separately in addition to code for primary procedure)
96416 Chemotherapy administration, intravenous infusion technique; initiation of
prolonged chemotherapy infusion (more that 8 hours), requiring use of a portable
or implantable pump

January 2018 39
CPT Code Code Description
96417 Chemotherapy administration, intravenous infusion technique; each additional
sequential infusion (different substance/drug), up to 1 hour (list separately in
addition to code for primary procedure
96420 Chemotherapy administration, intra-arterial; push technique
96422 Chemotherapy administration; intra-arterial; infusion technique, up to 1 hour
96423 Chemotherapy administration; intra-arterial; infusion technique, each additional
hour (list separately in addition to code for primary procedure)
96425 Chemotherapy administration; intra-arterial; infusion technique, initiation of
prolonged infusion (more than 8 hours), requiring the use of a portable or
implantable pump
96440 Chemotherapy administration into pleural cavity, requiring and including
thoracentesis
96446 Chemotherapy administration into peritoneal cavity via indwelling port or catheter
96450 Chemotherapy administration, into CNS (e.g. Intrathecal), requiring and including
spinal puncture
G0498 Chemo admin for IV/infusion; initiation in office & continued in home by using
portable pump

January 2018 40
 IV or Intra-Arterial Push
• Defined as:
– Injection which healthcare professional continuously
present to:
• Administer the drug
• Observe patient
OR
– An infusion of 15 minutes or less

January 2018 41
 Bundled into Chemotherapy
Administration
• Local anesthesia
• IV start
• Access to indwelling IV, subcutaneous catheter
or port
• Flush at conclusion of infusion
• Standard supplies
– Tubing, syringes
– Saline used in mixing drug(s)
• Preparation of chemotherapy agent(s)

January 2018 42
 145
Additional Services
• Office visit only for line maintenance
– Line irrigation and inspection of skin site
– Bill 99211
– No other drug administration service that day
• Declotting a catheter or port
– Bill 36593

January 2018 43
 CPT 99211
• Not allowed with or without modifier 25 on same
day as non-chemotherapy or chemotherapy
administration codes
• Not allowed for:
– Phone calls to patients
– Drawing of blood for laboratory analysis or when
performing other diagnostic tests
– Administration of medications when an injection or
infusion code is submitted separately

January 2018 44
 Chemotherapy Documentation
• Patient name, date of birth, and date of service
• Name and dosage of drug administered
• Infusion start and stop times for each drug to
support length of time infusion was administered
• Signed and dated physician order for drug(s)
administered, dosage, frequency and duration of
treatment
• Progress notes to support medical necessity
• Staff documentation matches codes billed
• Staff administering must sign, date/time and
credentials the admin sheet

January 2018 45
 Intramuscular and Subcutaneous
Injections
• Billed using 96372
Generic Trade HCPCS Generic Trade HCPCS
Name Name Code Name Name Code
Abatacept Orencia® J0129 Omalizumab Xolair® J2357

Canakinumab Ilaris® J0638

Tocilizumab Actemra® J3262

Certolizumab
Cimzia® J0717
Pegol Ustekinumab Stelera® J3357
Denosumab Prolia® / J0897
Xgeva®

January 2018 46
 Intramuscular and Subcutaneous
Injections (2)
• Intralesional administration of talimogen
laherparepvec (Imlygic™)
– Drug code J9325
– Administration 96405 or 96406
• Gonadotropin releasing hormone and analogs
used in treatment of cancer
– Including but not limited to J9217
– Administration 96402
• No other administration code
• Only when used for anticancer treatments

January 2018 47
 Infusions Non-Chemotherapy
• Billed using 96365-96379
Generic Trade HCPCS Generic Name Trade HCPCS
Name Name Code Name Code

Abatacept Orencia® J0129 Golimumab Simponi J1602

Aria®
Decitabine Dacogen J0894 Tocilizumab Actemra® J3262
®
Ecolizumab Soliris® J1300 Vedolizumab Entyvio® J3380

January 2018 48
 Infusions Chemotherapy
• Chemotherapy drugs
– J9000-J9999
• Appropriately billed using chemotherapy
administrative codes
– 96401-96549
• Additionally due to documented increased
infusion reactions and/or other reasons,
appropriate chemotherapy administration code
for infusion (or push) of following:

January 2018 49
 Infusions Chemotherapy (2)
Generic Trade HPCPS Generic Name Trade HPCPS
Name Name Codes Name Codes
Alemtuzumab Lemtrada J0202 Trabectedin Yondelis® J9352
1 mg ™ *
Daratumuma Darzalex™ J9145 Infliximab, Inflectra* Q5102-
b biosimilar 10 * ZB**
mg**
Elotuzumab Empliciti™ J9176
Infliximab, 10mg Remicade J1745
Irinotecan Onivyde™ J9205 ®
liposome Doxorubicin Doxil® Q2050
Necitumumab Portrazza J9295 hydrochloride,
™ liposomal, NOS

January 2018 50
 Asterisk Notes
* Infusion of trabectedin (J9352)
– Billed using unlisted chemotherapy code G0498
** Infliximab-dyyb (Q5102-ZB)
– Effective 4/5/16 processed 7/1/16 and after
– Must be billed with ZB modifier to distinguish from
Remicade
• Reminder: if patient returns for significant,
separately identifiable infusion or injection on
same day OR requires two IV lines
– 59 modifier

January 2018 51
 Prolonged Drug and Biological
Infusions Using an External Pump
• Hospital outpatient or physician may:
– Purchase drug for prolonged drug infusion
– Begin drug infusion in care setting
• Using external pump
– Send patient home for portion of infusion
– Have patient return at end of infusion
• A/B MAC is billed for:
– Drug or biological
– Administration
– External infusion pump
• Cannot be billed to the DME MAC
• See MLN Matters Special Edition Article 1609

January 2018 52
 Proper Billing to A/B MAC for Pump
Related to Prolonged Infusion
• Providers should not submit 96416 or another pump
code
• Instead submit this service using:
– G0498:
Chemotherapy administration, intravenous infusion technique; initiation of
infusion in the office/other outpatient setting using office/other outpatient
setting pump/supplies, with continuation of the infusion in the community
setting (e.g., home, domiciliary, rest home or assisted living) using a
portable pump provided by the office/other outpatient setting, includes
follow up office/other outpatient visit at the conclusion of the infusion.
• Local Coverage Article: Chemotherapy
Administration (A52953)
• https://med.noridianmedicare.com/documents/10546
/12461373/Chemotherapy+Administration

January 2018 53
Minimize Errors, Maximize
Revenue
Get it done right the first time!
 Place of Service
• Document place of service
• Reimbursement tied to the place of service; it
varies between the facility outpatient department
(22) and non-facility, such as the physician’s
office (11)
• Work with DME supplier for home (12) infusion
services

January 2018 55
 Advanced Beneficiary Notice (ABN)
• An ABN is required for payment prior to drug
administration if the treatment is known to be
denied by Medicare
• Remember that completion of an ABN must
contain the drug name as well as expected cost

January 2018 56
 Drug Formulation
• Be exact in reporting which drug formulation—
oral or IV—was ordered and billed
– Example: Oral anti-emetic drug Zofran (Q0162) is
ordered but the IV formulation of Zofran (J2405) is
documented and billed on claim
• The reverse is common as well: the IV
formulation is ordered and documented, but the
claim form indicates an oral formulation was
billed
• Verify correct units of service based on code

January 2018 57
 Discarded Drug- Modifier JW
• Detailed instructions regarding use of JW
modifier on CMS and Noridian website
– CMS: https://www.cms.gov/Regulations-and-
Guidance/Guidance/Manuals/Downloads/clm104c17.
pdf
– JE:
https://med.noridianmedicare.com/web/jeb/specialties
/oncology-hematology
– JF:
https://med.noridianmedicare.com/web/jfb/specialties/
oncology-hematology

January 2018 58
 MR Findings
• Insufficient documentation
• Signature requirements not met
• Failure to submit documents
• Wrong date of service
• Wrong provider
• Illegible documentation
• Duplicate billing
• Provider enrollment issues

January 2018 59
Resources
 CMS Resources
• IOM Publication 100-02, Medicare Benefit Policy
Manual, Chapter 15, Sections 50-50.6 and 60
– Incident to, Covered Medical Services, Off-label drugs
• IOM Pub 100-04, Medicare Claims Processing
Manual, Chapter 17, Sections 40, 80.8 and
100.2.9
– Drugs and Biologicals
• IOM Pub 100-04, Medicare Claims Processing
Manual, Chapter 12, Sections 30.5
– Chemotherapy Administration

January 2018 61
 Noridian Resources
• Browse by oncology specialty:
– JE:
https://med.noridianmedicare.com/web/jeb/specialties/onc
ology-hematology
– JF:
https://med.noridianmedicare.com/web/jfb/specialties/onco
logy-hematology
• Patients Supplying Their Own Drugs:
– JE:
https://med.noridianmedicare.com/web/jfb/topics/incident-
to-services/patients-supplying-own-drugs
– JF:
https://med.noridianmedicare.com/web/jeb/topics/incident-
to-services/patients-supplying-own-drugs

January 2018 62
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January 2018 63
Questions?
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