Medical Oncology Services and External Infusion Pumps. Part B Provider Outreach and Education February 2016

Medical Oncology Services and External Infusion Pumps Part B Provider Outreach and Education February 2016

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 http://www.noridianmedicare.com and the CMS website at http://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 2016 American Medical Association. All rights reserved. Applicable FARS/DFARS apply. February 2016 2

Agenda Overview Drugs and Biologicals Evaluation and Management Services Administration Hydration Therapeutic, prophylactic, diagnostic injections and infusions Chemotherapy External Infusion Pumps Durable Medical Equipment Minimize Common Errors CERT Reminders Resources February 2016 3

Helpful Acronyms ABN CERT ESA IOM LCD MPFS NCCI OCM RA SADs Advance Beneficiary Notice of Noncoverage Comprehensive Error Rate Testing Erythropoiesis-Stimulating Agents Internet Only Manual Local Coverage Determination Medicare Physician Fee Schedule National Correct Coding Initiative Oncology Care Model Recovery Auditor Self-Administered Drugs February 2016 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 February 2016 6

Oncologist Role 125 Treatment Counseling Diagnosis Disease dynamics Treatment options Recommended course of treatment February 2016 7

Oncology Disciplines Surgical oncology Radiation oncology Medical oncology February 2016 8

Medical Oncology Drugs and Biologicals

Office Chemotherapy Charges 126 Cost of drug(s) Incident to guidelines Administration cost Other covered services February 2016 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 Pharmacies can not bill Medicare Part B for drugs furnished to a physician for administration to a Medicare beneficiary Pharmacies, suppliers and providers can not bill Medicare Part B for drugs dispensed directly to a beneficiary for administration incident to a physician service, such as refilling an implanted drug pump February 2016 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 (Narrative) Drug Donated with description, strength and dosage when billing Not Otherwise Classified (NOC) HCPCS 24D Drug (J code) HCPCS 28 Billed amount of $0.00 or $0.01 February 2016 12

Medicare Drug Benefit 127 Not self administered Incident to physician service Reasonable and necessary Not excluded FDA approved February 2016 13

Medicare Drug Pricing 128 106 Percent of the Average Sales Price (ASP) Updated quarterly (CR9351) March 2015 February 2016 14

Top Adjudication Issues Unlisted codes or NOC J3490, J9999, and J3590 Name of the drug, NDC number and dosage Block 19 Electronic equivalent Bill the correct number of units Claims not providing adequate information deny unprocessable February 2016 15

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 129 February 2016 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 February 2016 17

ESA for Cancer Patients 132 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 February 2016 18

Billing Erythropoietin (EPO) 133 J0881 = Darbepoetin alfa J0885 = Epoetin Alfa ICD-10: Review Local Coverage Determinations: JE: JF: https://med.noridianmedicare.com/web/jeb/policies/lcd/active https://med.noridianmedicare.com/web/jfb/policies/lcd/active February 2016 19

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/R1/10.5 (hemoglobin) or TR/RT/32.3 (hematocrit) 133 February 2016 20

Medical Oncology & Evaluation & Management Services

Established Patient 99212-99215 Office or other outpatient visit for E/M of an established patient, which requires at least two of these three key components History Exam Decision making Levels depend on problems presented Records should tell a complete story of the patients condition February 2016 22

E /M Code Based on Time 136 50% of time or more Counseling Coordination of care Select code level by time Medical record Note counseling time Note total time of visit February 2016 23

Medical Record 136 Document Diagnosis Prognosis Treatment options Treatment plan Side effects Recovery February 2016 24

Administration Coding

Administration Services 139 Hydration Therapeutic, prophylactic, and diagnostic injections and infusions (excluding chemotherapy) Chemotherapy administration February 2016 26

Administration Coding Hydration

Hydration 140 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 February 2016 28

Hydration Time Billing Total Time of Hydration Infusion Billing Example 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 February 2016 29

Administration Coding Therapeutic, prophylactic diagnostic injections and infusions (excluding chemotherapy)

Infusion Codes Other than Chemotherapy 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 February 2016 31

Injections Codes Other than Chemotherapy 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) 96379 Unlisted February 2016 32

Included in Administration 142 Local anesthesia IV start Access to indwelling IV, subcutaneous catheter, or port Flush at conclusion of infusion Standard tubing, syringes and supplies Preparation of chemotherapy agent(s) February 2016 33

E/M and Injections/Infusions 142 Modifier 25 on E/M code with 96360 96361 96365 96379 Significant identifiable problem Clearly document February 2016 34

Administration Coding Chemotherapy Administration

96401 Chemotherapy administration, subcutaneous or intramuscular; non-hormonal anti-neoplastic 96402 Chemotherapy administration, subcutaneous or intramuscular; hormonal antineoplastic 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 February 2016 36

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 February 2016 37

Other Chemotherapy Administrations 96542 Injection, subarachnoid or intraventricular via subcutaneous reservoir, single or multiple agents 96549 Unlisted procedure February 2016 38

IV or Intra-Arterial Push 144 Healthcare professional continuously present Administer the drug Observe patient OR Infusion of 15 minutes or less February 2016 39

Bundled into Chemotherapy Administration 144 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) February 2016 40

Additional Services 145 Office visit only for line maintenance Line irrigation & inspection of skin site Bill 99211 IOM 100-4, Chapter 12 30.6.7 Declotting a catheter or port Bill 36593 February 2016 41

CPT 99211 Not allowed with or without the modifier 25 on the 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 February 2016 42

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 February 2016 43

Chemotherapy Billing Tips 145 Specific administration service(s) CPT codes Specific drug(s) or biological(s) used HCPCS codes Dosage Report code(s) for each method of administration Report only 1 initial service code Drugs given independently or sequentially to chemo Use 96360, 96361, 96365, 96379 February 2016 44

Additional Billing Tips 148 Report 1 initial service code Unless protocol requires 2 separate IV sites Modifier 76 if simultaneously Modifier 59 if different encounter Saline, anti-nausea or non-chemo drugs Same day sequentially covered Same day, same time - bundled February 2016 45

External Infusion Pumps Presented by the DME MAC for Jurisdiction D Local Coverage Determination L33794 and Policy Article A52507 National Coverage Determination 280.14

DMEPOS Payment Categories Capped rental item E0779, E0781, E0791 Paid on monthly basis Caps at 13 months Ownership transfers to beneficiary Inexpensive and Routinely Purchased items E0780 Can be rented or purchased February 2016 47

External Infusion Pump Reminders Beneficiary must use same pump during entire rental period Cannot change pumps for each round of chemotherapy Pump cannot be used on multiple beneficiaries Must comply will all supplier standards February 2016 48

Required Documentation Dispensing Order Detailed Written Order (DWO) DME Information Form (DIF) Medical records supporting condition requiring therapy Proof of refill requirements Proof of Delivery (POD) February 2016 49

Basic elements Beneficiary s name Physician s name DWO 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) Physician signature and signature date February 2016 50

DWO Additional Elements 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 February 2016 51

Revised DIF Drug changes Drug added DIF Include existing drugs listed along with all drugs used with pump February 2016 52

DMEPOS Resources LCD/Policy Article https://med.noridianmedicare.com/web/jddme/policies /lcd/active Supplier Manual https://med.noridianmedicare.com/web/jddme/educati on/supplier-manual Documentation Checklist https://med.noridianmedicare.com/web/jddme/policies /documentation-checklists DME Information Form (DIF) https://med.noridianmedicare.com/web/jddme/forms February 2016 53

Minimize Errors, Maximize Revenue Get it done right the first time!

Place of Service Document the 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) February 2016 55

Advanced Beneficiary Notice (ABN) An ABN is required for payment prior to drug administration if the treatment is known to be noncovered by Medicare Remember that completion of an ABN must contain the drug as well as potential cost February 2016 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 February 2016 57

Discarded Drug- Modifier JW If after administering a dose/quantity of the drug or biological to a Medicare patient, a provider must discard the remainder of a single use vial or other single use package, the program provides payment for the amount of drug or biological discarded as well as the dose administered, up to the amount of the drug or biological as indicated on the vial or package label Multi use vials not subject to payment Detailed instructions regarding use of JW modifier on Noridian website www.med.noridianmedicare.com https://www.cms.gov/regulations-and- Guidance/Guidance/Manuals/Downloads/clm104c17.pdf February 2016 58

99213-25 Insufficient Documentation Submitted Does not support beneficiary was seen for a significant, separately identifiable evaluation and management service by the same physician on the same day of the procedure or other service Submitted progress note states: Patient is here for chemo. No new problems. Same as last visit February 2016 59

Common Documentation Error Signature Requirements Legible full signature or first initial and last name Legible signature over typed or printed name Letterhead indicates name of signer Initials over typed or printed name, signature log Stamped signature never acceptable Additional information: http://www.cms.gov/outreach-and- Education/Medicare-Learning-Network- MLN/MLNMattersArticles/downloads/MM6698.pdf Attestation Statement available on our website February 2016 60

Electronic Signatures Providers using electronic systems need to recognize there is potential for misuse or abuse with alternate signature methods The individual whose name is on the alternate signature method and the provider bears the responsibility for authenticity of information being attested Signature Requirements FAQs https://med.noridianmedicare.com/web/jeb/certreviews/signature-requirement-q-a February 2016 61

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 February 2016 63

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/incidentto-services/patients-supplying-own-drugs JF: https://med.noridianmedicare.com/web/jeb/topics/incidentto-services/patients-supplying-own-drugs February 2016 64

E/M Guide 89 pages November 2014 1995/1997 guidelines February 2016 65

Upcoming Part B Webinars Date Time (CT/PT) Webinar Title 2/18/16 1:00 pm/11:00 am Global Surgery Modifiers 2/23/16 1:00 pm/11:00 am Influenza and Pneumonia Roster Billing 2/23/16 3:00 pm/1:00 pm Anesthesia Services 2/24/16 3:00 pm/1:00 pm Outpatient Therapy Services 2/29/16 11:00 am/9:00 am Appeals I The Basics 2/29/16 1:00 pm/11:00 am Chiropractic Basics REGISTER NOW! JE https://med.noridianmedicare.com/web/jeb/education/training-events JF https://www.noridianmedicare.com/partb/train/workshops/index.html February 2016 66

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