2020 CardioGen-82 (Rubidium Rb 82 Generator) …

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DISCLAIMERS The information provided here is general reimbursement information for CARDIOGEN-82 ® . It is not legal advice, nor is it advice about how to code, complete, or submit any particular claim for payment. Although we supply this information based on our current knowledge, it is always the provider’s responsibility to determine and submit appropriate codes, modifiers, and bills for the ser vices that were rendered. This coding and reimbursement information is subject to change without notice. Payer or their local branches may have their own coding and reimbursement requirements and policies. Before filling claims, provides should verify current requirements and policies with the payer. CPT ® copyright 2019 American Medical Association (AMA). All rights reserved. Fee schedules, relative value units, conversion factors, and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. CPT is a registered trademark of the American Medical Association. 2020 CardioGen-82 ® (Rubidium Rb 82 Generator) REIMBURSEMENT RESOURCE KIT TM

Transcript of 2020 CardioGen-82 (Rubidium Rb 82 Generator) …

Page 1: 2020 CardioGen-82 (Rubidium Rb 82 Generator) …

DISCLAIMERS

The information provided here is general reimbursement information for CARDIOGEN-82®. It is not legal advice, nor is it advice about how to code, complete, or submit any particular claim for payment. Although we supply this information based on our current knowledge, it is always the provider’s responsibility to determine and submit appropriate codes, modifiers, and bills for the ser vices that were rendered. This coding and reimbursement information is subject to change without notice. Payer or their local branches may have their own coding and reimbursement requirements and policies. Before filling claims, provides should verify current requirements and policies with the payer.

CPT® copyright 2019 American Medical Association (AMA). All rights reserved. Fee schedules, relative value units, conversion factors, and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly

or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

CPT is a registered trademark of the American Medical Association.

2020 CardioGen-82® (Rubidium Rb 82 Generator)

REIMBURSEMENT RESOURCE KIT

TM

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CONTENTS

CardioGen-82® (Rubidium Rb 82 Generator) Indications ................................................................................. 3

New for 2020 ............................................................................................................................................................ 4

Coding Nomenclature ..........................................................................................................................................5-6

Hospital Setting Billing ........................................................................................................................................... 7

Sample Hospital Setting Billing ............................................................................................................................ 8

Non-Hospital Outpatient Setting Billing .............................................................................................................. 9

Physician Office & IDTF Accreditation Information ......................................................................................... 10

Calculating The Cost Per Dose of Rubidium-82 ............................................................................................... 11

Sample Physician Billing Global Non-Hospital Outpatient Setting ............................................................... 12

Billing and Submitting Charges .......................................................................................................................... 13

Coverage ................................................................................................................................................................. 14

Coverage and Appropriate Use Information ..................................................................................................... 15

Reimbursement Hotline ........................................................................................................................................ 16

References ............................................................................................................................................................. 17

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CardioGen-82® INDICATIONS

TM

Indications and Usage:1 CARDIOGEN-82® (Rubidium Rb 82 Generator) is a closed system used to produce rubidium Rb 82 chloride injection for intravenous administration. Rubidium Rb 82 chloride injection is a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate regional myocardial perfusion in adult patients with suspected or existing coronary artery disease.

IMPORTANT SAFETY INFORMATION:

WARNING: HIGH LEVEL RADIATION EXPOSURE WITH USE OF INCORRECT ELUENT AND FAILURE TO FOLLOW THE ELUATE TESTING PROTOCOL

Please see full prescribing information for complete boxed warning

High Level Radiation Exposure with Use of Incorrect EluentUsing the incorrect eluent can cause high Strontium (Sr) 82 and Sr 85 breakthrough levels (5.1)• Use only additive-free 0.9% Sodium Chloride Injection USP to elute the generator (2.4)• Immediately stop the patient infusion and permanently discontinue the use of the affected CARDIOGEN-82® generator if the

incorrect solution is used to elute the generator (4)• Evaluate the patient’s radiation absorbed dose and monitor for the effects of radiation to critical organs such as bone

marrow (2.7)

Excess Radiation Exposure with Failure to Follow the Eluate Testing ProtocolExcess radiation exposure occurs when the levels of Sr 82 or Sr 85 in the rubidium Rb 82 chloride injection exceed limits. (5.2)• Record eluate volume, including waste and test volumes (2.4)• Strictly adhere to the generator eluate testing protocol (2.5)• Stop using the generator if it reaches any of its Expiration Limits (2.6)

Please see full Prescribing Information for CARDIOGEN-82® (Rubidium Rb 82 Generator) including boxed WARNING by clicking HERE.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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NEW for 2020

New CPT Codes2 – These codes apply to procedures performed with a PET/CT scannerCPT / HCPCS Code

Description

78429 Myocardial imaging, positron emission tomography (PET) metabolic evaluation study (including ventricular wall motion[s], and/or ejection fraction[s], when performed), single study; with concurrently acquired computed tomography transmission scan

78430 Myocardial imaging, positron emission tomography (PET), perfusion study (including ventricular wall motion[s], and/or ejection fraction[s], when performed) single study; at rest or stress (exercise or pharmacologic) with concurrently acquired computed tomography transmission scan

78431 Myocardial imaging, positron emission tomography (PET), perfusion study (including ventricular wall motion[s], and/or ejection fraction[s], when performed); multiple studies at rest and stress (exercise or pharmacologic), with concurrently acquired computed tomography transmission scan

78432 Myocardial imaging, positron emission tomography (PET), combined perfusion with metabolic evaluation study (including ventricular wall motion[s], and/or ejection fraction[s], when performed), dual radiotracer (eg, myocardial viability)

78433Myocardial imaging, positron emission tomography (PET), combined perfusion with metabolic evaluation study (including ventricular wall motion[s], and/or ejection fraction[s], when performed), dual radiotracer (eg, myocardial viability) with concurrently acquired computed tomography transmission scan

Existing codes 78491, 78492, and 78459 have new, expanded code descriptions. See pages 5 and 6.

New Add-On Code +784342

+78434

Absolute quantitation of myocardial blood flow (AQMBF), positron emission tomography (PET), rest and stress (List separately in addition to code for primary procedure) (Use 78434 in conjunction with 78431, 78492)

*New CPT Category 1 add-on code *Please note that +0482T has been deleted and replaced by this code

Medicare National Average Payment for New CodesCPT / HCPCS Code Description Payment4 Professional RVU (26)5

78429 PET/CT – Metabolic (FDG) $1,443.16 RVU 2.37

78430 PET/CT – Perfusion Single (Rb/Am) $1,443.16 RVU 2.25

78431 PET/CT Perfusion Multiple (Rb/Am) $2,250.50 RVU 2.62

78432 PET Perfusion single or multiple & Metabolic $2,750.50 RVU 2.79

78433 PET/CT Perfusion single or multiple & Metabolic $2,750.50 RVU 3.05

+78434 AQMBF PET rest & stress

Packaged into APC rate, rate is part of new technology payment * Providers should code and bill so costs are realized for future rates

RVU 0.88

What is AQMBF?3 Also known as myocardial blood flow, this is a specific measurement of the amount of blood that reaches a portion of the heart muscle in a specified amount of time.What is Coronary Flow Reserve (CFR)? This is the ratio of Stress MBF to Rest MBF. The MBF data must be generated before getting the CFR.What is the importance of AQMBF? Objective identification of patients with physiologically severe coronary artery disease of sufficient risk levels that support intervention.

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CODINGProcedure must be coded correctly in order to obtain appropriate reimbursement from both CMS and commercial payers. The following describes the types of codes that may be applied when submitting claims for a Myocardial Perfusion PET imaging study:

• CPT® – Current Procedural Terminology: Codes used to report the service or procedure that was performed and reported.

• HCPCS – Healthcare Common Procedure Coding System: Codes used to report the provision of supplies, materials, injections, and certain services and procedures. For example, the HCPCS code for Rubidium 82 is A9555.

• ICD-10 – International Classification of Disease: Codes used to describe signs or symptoms of the patient that would represent a medically necessary reason for performing the procedure.

• NDC – National Drug Code CardioGen-82®: 00270-0091-01

CODING NOMENCLATURE

* The description for these codes has been expanded for 2020

CPT / HCPCS Code Description

PROCEDURE2

*78491 Myocardial Imaging, positron emission tomography (PET), perfusion study (including ventricular wall motion[s] and/or ejection fraction[s], when performed); single study, at rest or stress (exercise or pharmacologic)

78430 Myocardial Imaging, positron emission tomography (PET), perfusion study (including ventricular wall motion[s], and/or ejection fraction[s], when performed) single study; with concurrently acquired computed tomography transmission scan

*78492 Myocardial Imaging, positron emission tomography (PET), perfusion study (including ventricular wall motion[s] and/or ejection fraction[s], when performed); multiple studies at rest and stress (exercise or pharmacologic)

78431Myocardial Imaging, positron emission tomography (PET), perfusion study (including ventricular wall motion[s], and/or ejection fraction[s], when performed); multiple studies at rest and stress (exercise or pharmacologic), with concurrently acquired computed tomography transmission scan

78432 Myocardial Imaging, positron emission tomography (PET), combined perfusion with metabolic evaluation study (including ventricular wall motion[s], and/or ejection fraction[s], when performed), dual radiotracer (eg, myocardial viability)

78433Myocardial Imaging, positron emission tomography (PET), combined perfusion with metabolic evaluation study (including ventricular wall motion[s], and/or ejection fraction[s], when performed), dual radiotracer (eg, myocardial viability) with concurrently acquired computed tomography transmission scan

+78434 Absolute quantitation of myocardial blood flow (AQMBF), positron emission tomography (PET), rest and stress (List separately in addition to code for primary procedure) (Use 78434 in conjunction with 78431 and 78492)

*78459 Myocardial imaging, positron emission tomography (PET), metabolic evaluation study (including ventricular wall motion[s] and/or ejection fraction[s], when performed), single study

78429 Myocardial Imaging, positron emission tomography (PET), metabolic evaluation study (including ventricular wall motion[s], and/or ejection fraction[s], when performed) single study; with concurrently acquired computed tomography transmission scan

STRESS TEST2

93015 Cardiovascular Stress Test Using Maximal or Sub-Maximal Treadmill or Bicycle Exercise, Continuous Electrocardiographic Monitoring, and/or Pharmacological Stress; With Physician Supervision, With Interpretation and Report

93016 Cardiovascular Stress Test Using Maximal or Sub-Maximal Treadmill or Bicycle Exercise, Continuous Electrocardiographic Monitoring, and/or Pharmacological Stress; Physician Supervision Only, Without Interpretation and Report

93017 Cardiovascular Stress Test Using Maximal or Sub-Maximal Treadmill or Bicycle Exercise, Continuous Electrocardiographic Monitoring, and/or Pharmacological Stress; Tracing Only, Without Interpretation and Report

93018 Cardiovascular Stress Test Using Maximal or Sub-Maximal Treadmill or Bicycle Exercise, Continuous Electrocardiographic Monitoring, and/or Pharmacological Stress; Interpretation and Report Only

NEW for 2020

NEW for 2020

NEW for 2020

NEW for 2020

NEW for 2020

NEW for 2020

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CODINGProcedure must be coded correctly in order to obtain appropriate reimbursement from both CMS and commercial payers. The following describes the types of codes that may be applied when submitting claims for a Myocardial Perfusion PET imaging study:

• CPT® – Current Procedural Terminology: Codes used to report the service or procedure that was performed and reported.

• HCPCS – Healthcare Common Procedure Coding System: Codes used to report the provision of supplies, materials, injections, and certain services and procedures. For example, the HCPCS code for Rubidium 82 is A9555.

• ICD-10 – International Classification of Disease: Codes used to describe signs or symptoms of the patient that would represent a medically necessary reason for performing the procedure.

• NDC – National Drug Code CardioGen-82®: 00270-0091-01

CODING NOMENCLATURE (continued)

CPT / HCPCS Code Description

RADIOPHARMACEUTICAL DRUG6

A9555 Rubidium Rb-82, Diagnostic, Per Study Dose, Up to 60 mCi

PHARMACOLOGICAL STRESS AGENTS6

J0153 Injection, Adenosine for Diagnostic Use, 1 mg (Not to be Used to Report Any Adenosine Phosphate Compounds)

J1245 Injection, Dipyridamole, Per 10 mg

J1250 Injection, Dobutamine Hydrochloride, Per 250 mg

J2785 Injection, Regadenoson, 0.1 mg

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HOSPITAL SETTING BILLING

MEDICARE• Hospital Outpatient Prospective Payment System (HOPPS)

The Medicare HOPPS applies to almost all hospital outpatient departments and is based on previous years’ claims data. For example, HOPPS payment rates for 2019 are based on 2017 hospital claims data. The HOPPS payments cover only facility or technical fees and are geographically adjusted.

It is essential that hospitals continue to code and apply appropriate charges to items and services that may be packaged or bundled into the procedural payment. For example, diagnostic radiopharmaceuticals are packaged but still should be coded and charged in order for the cost to be represented in the claims data.

Hospital Revenue Codes for Chargemaster – Hospital Outpatient Department7

Revenue Codes Imaging Procedures

0404 Other Imaging Services – Positron Emission Tomography

0340 Nuclear Medicine – General Classification

0341 Nuclear Medicine – Diagnostic

Revenue Code Radiopharmaceuticals & Non-Radioactive Materials

0343 Nuclear Medicine, Diagnostic Radiopharmaceutical Drugs (use only if payer requests for Dx Rps)

Revenue Code Cardiac Stress Testing

0482 Cardiology – Stress Test

Revenue Code Cardiac Stress Testing- pharmacologic stress agent/drug

0636 Drugs required detailed coding

HOPPS Medicare National Average Payment4

CPT Code APC 2015 2016 2017 2018 2019 2020

78459: PET, Metabolic Evaluation 5593 $1,286.23 $1,285.17 $1,138.44 $1,202.60 $1,229.38 $1,272.19

78491: PET MPI, Single 5594 $1,286.23 $1,285.17 $1,320.97 $1,377.12 $1,375.54 $1,443.16

78492: PET MPI, Multiple 5594 $1,286.23 $1,285.17 $1,320.97 $1,377.12 $1,375.54 $1,443.16

CONSIDERATIONS FOR DEVELOPING CHARGES:• Discuss the professional and technical work with your chargemaster team• Look for other services that may have similar costs that are already established• Take into account the cost of new equipment or software including the time for the technologists/physician• Include the acquisition cost of drugs/pharmaceuticals and devices used in the procedure

HOPPS Medicare National Average Payment for New Codes4

CPT / HCPCS Code Description Payment78429 PET/CT – Metabolic (FDG) $1,443.16

78430 PET/CT – Perfusion Single (Rb/Am) $1,443.16

78431 PET/CT Perfusion Multiple (Rb/Am) $2,250.50

78432 PET Perfusion single or multiple & Metabolic $2,750.50

78433 PET/CT Perfusion single or multiple & Metabolic $2,750.50

+78434 AQMBF PET rest & stressPackaged into APC rate, rate is part of new technology payment *Providers should code and bill so costs are realized for future rates

NEW for 2020

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Sample Hospital Setting BillingUB-04 CMS-1450

MPI PET MULTIPLE STUDY WITH PHARMACOLOGIC STRESS

1 2 4 TYPEOF BILL

FROM THROUGH5 FED. TAX NO.

abc

d

DX

ECI

1

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A

B

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A B C D E F G HI J K L M N O P Q

a b c a b c

a

b c d

ADMISSION CONDITION CODESDATE

OCCURRENCE OCCURRENCE OCCURRENCE OCCURRENCE SPAN OCCURRENCE SPANCODE DATE CODE CODE CODE DATE CODE THROUGH

VALUE CODES VALUE CODES VALUE CODESCODE AMOUNT CODE AMOUNT CODE AMOUNT

TOTALS

PRINCIPAL PROCEDURE a. OTHER PROCEDURE b. OTHER PROCEDURE NPICODE DATE CODE DATE CODE DATE

FIRST

c. d. e. OTHER PROCEDURE NPICODE DATE DATE

FIRST

NPI

b LAST FIRST

c NPI

d LAST FIRSTUB-04 CMS-1450

7

10 BIRTHDATE 11 SEX 12 13 HR 14 TYPE 15 SRC

DATE

16 DHR 18 19 20

FROM

21 2522 26 2823 27

CODE FROM

DATE

OTHER

PRV ID

THE CERTIFICATIONS ON THE REVERSE APPLY TO THIS BILL AND ARE MADE A PART HEREOF.

b

.INFO

BEN.

CODEOTHER PROCEDURE

THROUGH

29 ACDT 30

3231 33 34 35 36 37

38 39 40 41

42 REV. CD. 43 DESCRIPTION 45 SERV. DATE 46 SERV. UNITS 47 TOTAL CHARGES 48 NON-COVERED CHARGES 49

52 REL51 HEALTH PLAN ID 53 ASG. 54 PRIOR PAYMENTS 55 EST. AMOUNT DUE 56 NPI

57

58 INSURED’S NAME 59 P.REL 60 INSURED’S UNIQUE ID 61 GROUP NAME 62 INSURANCE GROUP NO.

64 DOCUMENT CONTROL NUMBER 65 EMPLOYER NAME

66 67 68

69 ADMIT 70 PATIENT 72 73

74 75 76 ATTENDING

80 REMARKS

OTHER PROCEDURE

a

77 OPERATING

78 OTHER

79 OTHER

81CC

CREATION DATE

3a PAT.CNTL #

24

b. MED.REC. #

44 HCPCS / RATE / HIPPS CODE

PAGE OF

APPROVED OMB NO. 0938-0997

e

a8 PATIENT NAME

50 PAYER NAME

63 TREATMENT AUTHORIZATION CODES

6 STATEMENT COVERS PERIOD

9 PATIENT ADDRESS

17 STAT STATE

DX REASON DX 71 PPS

CODE

QUAL

LAST

LAST

National UniformBilling CommitteeNUBC

OCCURRENCE

QUAL

QUAL

QUAL

LIC9213257

CODE DATE

A

B

C

A

B

C

A

B

C

A

B

C

A

B

C

a

b

a

b

Hospital NameOne Hospital PlaceCity, State 00000

0404 PET/CT, Perfusion Multiple (Rb/Am)

0343 Rubidium per Dose0482 Cardiac Stress Test0636 Pharmacologic Stress Agent

78431+78434A955593017

XXXX XXXXX XXXXX XXXXX XX

1121

01/14/202001/14/202001/14/202001/14/2020

Pay - To NamePay - To Address(if different from billing provider in FL1)

Payer NamePayer Address

41000

Form Locator 46 (Units of Service)Enter the number of units based on the HCPCS code descriptor

Form Locator 44 (HCPCS/Rates/HOPPS Code)Enter the CPT of HCPCS code for the procedure, radiopharmaceutical and drug78431 PET/CT Perfusion Multiple (Rb/Am)A9555 Rubidium Rb-82, diagnostic, per study dose, up to 60 mCi

Form Locator 42 (Rev. CD.)Enter Revenue Code – For Example:0308 PET or 0341 Nuclear Medicine Diagnostic (Verify Revenue Coding with Hospital Finance Dept.)0343 Diagnostic Radiopharmaceutical 0482 Cardiac Stress Test0636 Drugs requiring detailed coding

Bracco Diagnostics Inc. cannot guarantee coverage or payment for products or procedures at any particular level. For more specific information please contact your Medicare contractor or the patient’s insurer.

Form Locator 67 (Principle Diagnosis Code)Enter the ICD-10 code for the principal diagnosesFor Example:R94.3 Abnormal electrocardiogram [ECG] [EKG] I24.9 Acute Ischemic disease, unspecified.Special note: Do not use the decimal place on the claim form, it may cause rejection of the claim form. Up to eight other diagnoses that co-exist in addition to theprinciple diagnosis can be reported in FL 67 A-H.

0404 AQMBF PET rest & stress

JXXX 01/14/2020 1

+78434 Absolute quantitation of myocardial blood flow, PET, rest and pharmacologic stress93017 Cardiovascular Stress Test, tracing only, without interpretation and reportUse the appropriate HCPCS code for the pharmacological stress used to perform the study

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NON-HOSPITAL OUTPATIENT SETTING BILLING

IDTF/PHYSICIAN OFFICE SETTING

The Medicare Physician Fee Schedule (MPFS) applies to procedures, products, and services performed in the Independent Diagnostic Testing Facility (IDTF) or office setting as well as the professional component. CMS sets payment rates for procedures and physician services based on assigned Relative Value Units (RVU). These RVU are multiplied by a conversion factor and the payments are then geographically adjusted.

CMS has not accepted or published the American Medical Association (AMA) Relative Value Update Committee (RUC) approved RVU for the technical component of MPI PET procedures. The technical component of these procedures is priced by the Medicare Administrative Contractor (MAC) under the MPFS. However, due to the Deficit Reduction Act (DRA), any rate a contractor could set would be capped at the HOPPS calculated technical rate. The rate can be lower but can be no higher than the wage-adjusted HOPPS CAP rate.

To find the reimbursement for your locality you can access your MAC (Medicare Administrative Contractor) website at: https://www.cms.gov/Medicare/Medicare-Contracting/Medicare-Administrative-Contractors/Who-are-the-MACs.html or use the CMS Physician Fee Schedule Look-Up Tool at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PFSlookup/index.html

Diagnostic radiopharmaceuticals are paid separately in the IDTF/office setting. Some MACs pay a set fee per dose, some pay based on an invoice. Check your local MAC to determine their method of payment.

PROFESSIONAL COMPONENTThe MPFS applies to the professional component of procedures performed in both the outpatient hospital and IDTF/office settings.

CPT Code 2015* 2016* 2017* 2018* 2019* 2020*78459-26: PET, Metabolic Evaluation

RVU 2.06 RVU 2.00 RVU 2.00 RVU 2.01 RVU 2.01 RVU 2.15

78491-26: PET, MPI, Single

RVU 2.07 RVU 2.02 RVU 2.03 RVU 2.02 RVU 2.02 RVU 2.09

78492-26: PET, MPI, Multiple

RVU 2.60 RVU 2.54 RVU 2.55 RVU 2.55 RVU 2.55 RVU 2.46

* Centers for Medicare & Medicaid Services. Physician Fee Schedule Look-Up Tool. Centers for Medicare & Medicaid Website. www.cms.gov/Medicare/Medicare-Fee-For-Service-Payment/PFSlookup/index.html. Accessed January 11, 2019.

CONSIDERATIONS FOR DEVELOPING CHARGES:• Discuss the professional and technical work with your chargemaster team• Look for other services that may have similar costs that are already established• Take into account the cost of new equipment or software including the time for the technologists/physician• Include the acquisition cost of drugs/pharmaceuticals and devices used in the procedure

Professional Component (26)CPT / HCPCS Code Description RVU5

78429 PET/CT – Metabolic (FDG) RVU 2.37

78430 PET/CT – Perfusion Single (Rb/Am) RVU 2.25

78431 PET/CT Perfusion Multiple (Rb/Am) RVU 2.62

78432 PET Perfusion single or multiple & Metabolic RVU 2.79

78433 PET/CT Perfusion single or multiple & Metabolic RVU 3.05

+78434 AQMBF PET rest & stress RVU 0.88

NEW for 2020

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PHYSICIAN OFFICE & IDTF ACCREDITATION INFORMATION

Updating Medicare Forms:

Physician Offices:

• Update PECOS – form 855i More information is available at: https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/Downloads/cms855i.pdf

Independent Diagnostic Imaging Centers:

• Update PECOS: IDTF: Independent Imaging Centers – update from: 855b More information available at: https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/Downloads/cms855b.pdf

Accreditation:

Intersocietal Accreditation Commission IAC-Nuclear/PET and ACR: American College of Radiology

• For more information visit the websites:

IAC: https://www.intersocietal.org/nuclear/

ACR: https://www.acraccreditation.org/modalities/nuclear-medicine-and-pet

Billing and Accreditation:

• The conditions under which you can bill during your accreditation process varies for both Medicare and Commercial payers.

• Contact the accreditation body for more information by calling or accessing their websites: IAC: https://www.intersocietal.org/nuclear/main/payment_policies.htm or phone: % 1-800-838-2110 ACR: https://www.acraccreditation.org/modalities/nuclear-medicine-and-pet

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Rubidium Rb-82 is supplied to the imaging department in the form of CARDIOGEN-82® (Rubidium Rb 82 Generator). The generator is used by the department to dispense doses of Rb-82 over a specific period of time.

Calculating the Cost Per Dose of Rubidium Rb 82: NDC number: 00270-0091-01The cost of a single dose of the product is determined by dividing the cost of the generator by the number of doses dispensed from the generator over the life cycle of the specific generator. Document your process and review on a regular basis as your practice evolves.

CALCULATING THE COST PER DOSEOF RUBIDIUM-82

($X) / (Y) = Cost per dose

X = $ for the generator Y = # of doses dispensed

Indications and Usage: CARDIOGEN-82® (Rubidium Rb 82 Generator) is a closed system used to produce rubidium Rb 82 chloride injection for intravenous administration. Rubidium Rb 82 chloride injection is a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate regional myocardial perfusion in adult patients with suspected or existing coronary artery disease.

IMPORTANT SAFETY INFORMATION:

WARNING: HIGH LEVEL RADIATION EXPOSURE WITH USE OF INCORRECT ELUENT AND FAILURE TO FOLLOW THE ELUATE TESTING PROTOCOL

Please see full prescribing information for complete boxed warning

High Level Radiation Exposure with Use of Incorrect EluentUsing the incorrect eluent can cause high Strontium (Sr) 82 and Sr 85 breakthrough levels (5.1)• Use only additive-free 0.9% Sodium Chloride Injection USP to elute the generator (2.4)• Immediately stop the patient infusion and permanently discontinue the use of the affected CARDIOGEN-82® generator if the

incorrect solution is used to elute the generator (4)• Evaluate the patient’s radiation absorbed dose and monitor for the effects of radiation to critical organs such as bone

marrow (2.7)

Excess Radiation Exposure with Failure to Follow the Eluate Testing ProtocolExcess radiation exposure occurs when the levels of Sr 82 or Sr 85 in the rubidium Rb 82 chloride injection exceed limits. (5.2)• Record eluate volume, including waste and test volumes (2.4)• Strictly adhere to the generator eluate testing protocol (2.5)• Stop using the generator if it reaches any of its Expiration Limits (2.6)

Please see full Prescribing Information for CARDIOGEN-82® (Rubidium Rb 82 Generator) including boxed WARNING by clicking HERE.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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Sample Physician Billing Global Non-Hospital Outpatient Setting CMS-1500MPI PET MULTIPLE STUDY WITH PHARMACOLOGIC STRESS

www.nucc.org

APPROVED BY NATIONAL UNIFORM CLAIM

PICA PICA

123

4

56

NPI

NPI

( )

17a.

I.

17b. NPI

M

payment of medical benefits to the undersigned physician or supplier for services described below.to process this claim. I also request

below.

18. HOSPITALIZATION DATES RELATED TO CURRENT SERVICES

16. DATES PATIENT UNABLE TO WORK IN CURRENT OCCUPATION15. OTHER DATE

DATE

c. OTHER ACCIDENT?

YES NO PLACE (State)b. RESERVED FOR NUCC USE

Self

M F MM DD YY

J.

PROVIDER ID. #

YES NO If yes, complete items 9, 9a, and 9d.

YES NO

YES NO

1. MEDICARE MEDICAID

c. RESERVED FOR NUCC USE

6. PATIENT RELATIONSHIP TO INSURED

( )

b. OTHER CLAIM ID (Designated by NUCC)

d. IS THERE ANOTHER HEALTH BENEFIT PLAN?

READ BACK OF FORM BEFORE COMPLETING & SIGNING THIS FORM.

22. RESUBMISSION

23. PRIOR AUTHORIZATION NUMBER

F.

19. ADDITIONAL CLAIM INFORMATION (Designated by NUCC)

24. A. B. C. D. PROCEDURES, SERVICES, OR SUPPLIES (Explain Unusual Circumstances)

MODIFIERCPT/HCPCS

E.

POINTER

For govt. claims, see back$

(I certify that the statements on the reverse apply to this bill and are made a part thereof.)

a. EMPLOYMENT? (Current or Previous)

( )

b. AUTO ACCIDENT?

A.

PLEASE PRINT OR TYPE

HEALTH INSURANCE CLAIM FORM

(Medicare#) (Medicaid#) (ID#/DoD#) (Member

TRICARE CHAMPVA

(ID#)ID#)

FECA OTHER(ID#) (ID#)

Spouse Child Other

ZIP CODE TELEPHONE (Include Area Code)

MM YY DD

STATE 8. RESERVED FOR NUCC USE

(Include Area Code) ZIP CODE

CITY

TELEPHONE

I authorize the release of any medical or other information necessarypayment of government benefits either to myself or to the party who accepts assignment

MM YY DD

10d. CLAIM CODES (Designated by NUCC)

DATE(S) OF SERVICEFrom

MM DDTo

YY MM DD YY

I authorize

MM YY DD MM YYDDFROM

MM YYDDTO

MM YYDDFROM

MM YYDDTO

20. OUTSIDE LAB?

CODE

YES NO

L REF. NO.

PLACE OFSERVICE

DAYS

UNITSOR

H.EPSDT

PlanFamily

QUAL.ID.

NPI

NPI

NPI

NPI

NPI

DATE

25. FEDERAL TAX I.D. NUMBER SSN EIN

YES NO $

29. AMOUNT PAID 30. Rsvd.for NUCC Use

32. SERVICE FACILITY LOCATION INFORMATION

a. b.

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78492

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93015

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STATE CITY

Rubidium Rb-82 per dose (Only if required by MAC or payoff)Unlisted Procedure Wall Motion and Election Fraction (See pg. 2)

41400 78650 49320

Form Locator 19 & 24D: Global Billing ExampleFL 19 - In order to facilitate coverage and payment, provide a description of the radiopharmaceutical (if required), and a description of unlisted procedures if necessary.See Medicare contractors or private payer instructions for information required.FL 24D - Enter CPT or HCPCS code for procedures performed and interpreted by the physician.78434 Absolute quantitation of myocardial blood flow, PET, rest and pharmacologic stress

Form Locator 21 & 24EEnter ICD-10 code for principal diagnosis in FL 21.For example: CR94.3 Abnormal electrocardiogram [ECG] [EKG]I24.9 Acute Ischemic disease, unspecified.

Special note: Do not use the decimal place on the claim form, it may cause rejection of the claim form.

Enter the letter corresponding to the diagnosis code for the procedure in FL 24E

Form Locator 24G Enter the number of units based on the CPT or HCPCS code description.

Note: Rb-82 description is per dose. For multiple studies, two doses are administered; place (2) in units. *Also check units for stress agent, utilizing the HCPCS code long description.

Bracco Diagnostics Inc. cannot guarantee coverage or payment for products or procedures at any particular level. For more specific information please contact your Medicare contractor or the patient’s insurer.

78492 Myocardial Imaging, PET, perfusion; multiple studies at rest and/or stress93015 Cardiovascular Stress Test; supervision, interpretation and reportG0235 / 78499 - Unlisted Cardiovascular Procedure, diagnostic nuclear medicine A9555 Rubidium Rb-82 diagnostic, per study dose, up to 60 millicuriesJxxxx Injection. Pharmacologic Stress Agent - *Select HCPCS code to represent agent used.

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BILLING AND SUBMITTING CHARGES

The provider has included the…

✓ PET procedure code

✓ Cardiac Stress Test code

✓ Radiopharmaceutical agent

✓ Pharmacologic stress agent

✓ Proper service units

✓ Principal diagnostic code (and secondary if applicable)

✓ Applicable revenue codes (hospital only)

✓ Documentation providing the medical necessity for all codes billed (including add-on codes)

✓ Use of Clinical Decision Support Mechanism (CDSM) for appropriate use criteria (AUC) https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/index

Checks to Success

Properly submitted bills and charges are used in creating Medicare Fee Schedules. Ensuring that all aspects of the procedure are accounted for is necessary to support appropriate payment rates in the future.

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Medicare

National Coverage Determination: The Centers for Medicare and Medicaid Services (CMS) has a National Coverage Determination (NCD) in place for cardiac PET imaging. This NCD is available on the CMS site at: https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R31NCD.pdf

The NCD states that cardiac PET procedures, performed at rest or with pharmacologic stress, used for noninvasive imaging of the perfusion of the heart for the diagnosis and management of patients with known or suspected coronary artery disease using the FDA-approved radiopharmaceutical Rubidium-82 (Rb-82) are covered, provided the requirements below are met:

• The PET scan, whether at rest alone or rest with stress, is performed in place of, but not in addition to, a single photon emission computed tomography (SPECT); or

• The PET scan, whether at rest alone or rest with stress, is used following a SPECT that was found to be inconclusive.

In these cases, the PET scan must have been considered necessary in order to determine what medical or surgical intervention is required to treat the patient. (For purposes of this requirement, an inconclusive test(s) whose results are equivocal, technically uninterpretable, or discordant with a patient’s other clinical data must be documented in the beneficiary’s file.)

Local Coverage Decision and Local Coverage Article: LCD/ LCAIn addition to the NCD, Local Coverage Determinations (LCD) and Local Coverage Articles (LCA) may be issued by the Medicare Administrative Contractors (MAC). The LCD and LCA specify under what clinical circumstances a service is considered to be reasonable and medically necessary. They often provide the list of ICD-10 codes by procedure or group of procedure codes. It is important to identify if your regional MAC has issued an LCD or LCA related to cardiac PET studies. These policies are available at: https://www.cms.gov/medicare-coverage-database/overview-and-quick-search.aspx , using Advanced Search is recommended.

To find your Medicare Administrative Contractor (MAC) go to: https://www.cms.gov/Medicare/Medicare-Contracting/Medicare-Administrative-Contractors/MedicareAdministrativeContractors.html

Private/Commercial Payers

Private or commercial insurance plans may publish coverage policies and many will utilize a Radiology Benefit Management (RBM) company to pre-authorize claims. The following is a list of several of the RBM companies:

COVERAGE

Clinical guidelines for each of these RBM companies are provided on the web at the addresses shown or via the commercial insurer. Unlike Medicare, Commercial payers require pre-authorization most of the time. Make sure you use the forms designated by the payer or RBM. Medicare Advantage often have their own specific plans and pre-authorization requirements that may differ from other commercial plans.

Medicaid: Medicaid is administered at the state level. Each state determines their coverage and pre-authorization requirements.

EviCore www.evicore.com

American Imaging Management (AIM) www.americanimaging.net

National Imaging Associates (NIA) www.niahealthcare.com

Health Help www.healthhelp.com

Care to Care www.caretocare.com

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Medicare and several insurance companies recognize that cardiac PET is covered in place of cardiac SPECT in patients with conditions that may cause attenuation problems. It is important to recognize these conditions and discuss them with the insurance payer if coverage of the cardiac PET study is questioned. These conditions should be clearly indicated in the patient report and taken into consideration when ordering a cardiac PET study.

Cardiac PET has a greater ability to avoid attenuation artifacts that degrade image quality and increase the risk of an inconclusive cardiac SPECT study. Several factors may increase photon attenuation and result in image artifacts including, but not limited to, the following6:

COVERAGE AND APPROPRIATE USE INFORMATION

• Diaphragmatic attenuation

• Breast tissue

• Previous mastectomy

• Breast implants

• Patient position

• Chest wall deformity

• Bowel loop

• Pleural or pericardial effusion

• Body size

• Scar tissue

When compared to Single Photon Emission Computed Tomography (SPECT) myocardial perfusion imaging, cardiac PET offers the following benefits:

• Greater diagnostic accuracy resulting in reduced serial testing9,10

• More rapid imaging protocols11,12

• Lower patient and occupational staff radiation exposure13-15

• Fewer soft-tissue attenuation issues for improved imaging and reduced serial testing9-12

Appropriate Use ReferencesThe following are articles that review the appropriate use of Cardiac Radionuclide and Cardiac PET Imaging:

• ACCF/ASNC/ACR/AHA/ASE/SCCT/SCMR/SNM 2009 Appropriate Use Criteria for Cardiac Radionuclide Imaging, Journal of the American College of Cardiology, June 9, 2009, Hendel et al. (https://www.asnc.org/files/AUC%20for%20Cardiac%20Radionuclide%20Imaging.pdf)

• ASNC Model Coverage Policy: Cardiac positron emission tomographic imaging, Journal of Nuclear Cardiology, Sept/Oct 2013, Heller et al. (https://www.asnc.org/files/Model%20Coverage%20Policy-PET%202014.pdf)

• Bateman TM, Dilsizian V, Beanlands RS, DePuey EG, Heller GV, Wolinsky DA. American Society of Nuclear Cardiology and Society of Nuclear Medicine and Molecular Imaging joint position statement on the clinical indications for myocardial perfusion PET. J Nucl Cardiol. 2016;23(5):1227-1231. Can be accessed on line at: https://www.asnc.org/files/Guidelines%20and%20Quality/ASNCandSNMMIJointPETPositionPaper2016.pdf

The American Society of Nuclear Cardiology (ASNC) and the Society for Nuclear Medicine and Molecular Imaging (SNMMI) have issued a joint statement on the clinical indications for myocardial perfusion PET8:

According to the ASNC/SNMMI, myocardial perfusion PET is:

• First line preferred for patients with known or suspected CAD undergoing pharmacologic stress testing

• Recommended for patients who meet appropriate criteria for stress imaging such as:

– Patients with body characteristics that commonly affect image quality (ex. Large breasts, obesity)

– High-risk patients such as those with diabetes or kidney disease

– Patients with body positioning challenges

– Patients who may benefit from revascularization

– Young patients with established CAD

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REIMBURSEMENT HOTLINE

[email protected]

1-800-349-1388

How we support youThe Bracco Reimbursement Hotline is here to support you for all your reimbursement needs.

Ask coding and billing questions regarding Bracco Diagnostics products and procedures related to those products.

HCPCS codes for products

CPT and HCPCS codes for procedures

Medicare payments

Monday-Friday: 9:00 AM-6:00 PM Eastern Time

✓✓✓✓

For more information on reimbursement, contact the Bracco Reimbursement Hotline at:

Access a Q&A Searchable Database:

✓ Search by topics and gain access to the archived Q&A

✓ Reach the hotline from the webpage

✓ Organized by Radiology, Nuclear Medicine, Ultrasound, Cardiology, and Documentation

Receive Bi-monthly Reimbursement/Compliance Question & Answers

Sign up to automatically receive our Q&As

To get the most benefit from this service as a Bracco customer, we encourage you to:

✓ Bookmark the Q&A webpage to search for topics of interest Q&A on specific topics

✓ Sign up and receive the Q&A every two weeks

Go to the Q&A webpage below at: http://bracco.panaceainc.com/

Sign up today at: http://bracco.panaceainc.com/

bracco-qa-signup-form/

PLUS you will receive email invitations for accredited reimbursement webinars throughout the year!

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REFERENCES

CardioGen-82 is manufactured for Bracco Diagnostics Inc., Monroe Township, NJ 08831, by GE Healthcare, Medi-Physics, Inc., South Plainfield, NJ 07080.

CARDIOGEN-82 is a registered trademark of Bracco Diagnostics Inc.

Bracco Diagnostics Inc.259 Prospect Plains Road, Building HMonroe Township, NJ 08831 USA Phone: 609-514-2200Toll Free: 1-877-272-2269 (U.S. only)Fax: 609-514-2446

©2020 Bracco Diagnostics Inc. All Rights Reserved.

References: 1. Cardiogen-82 (Rubidium Rb 82 Generator) for Positron Emission Tomography Myocardial Perfusion Imaging, full Prescribing Information. Monroe Twp, NJ: Bracco Diagnostics Inc. April 2019. 2. American Medical Association. 2020 Professional Edition CPT® current procedural terminology. Chicago, IL: American Medical Association; 2019: 515, 516, 670. 3. Hurst The Heart. 4. CMS-1717-FC: Hospital Outpatient Prospective Payment- Notice of Final Rulemaking (NFRM) with Comment Period Year 2019. Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs. https://www.cms.gov/newsroom/fact-sheets/cy-2020-medicare-hospital-outpatient-prospective-payment-system-and-ambulatory-surgical-center-0 - Addendum B. 5. CMS 1715-F Revisions to Payment Policies under Medicare Physician Fee Schedule, Payment Program and Other Revisions to Pay B for CY 2020 https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices-Items/CMS-1715-F - Addendum B. 6. American Medical Association. HCPCS Level II Professional 2020. Chicago IL: American Medical Association; 2020: 138, 296, 302, 303, 311. 7. Hospital Revenue Codes 2020 https://med.noridianmedicare.com/web/jea/topics/claim-submission/revenue-codes -accessed Jan 2, 2020. 8. Bateman TM, Dilsizian V, Beanlands RS, DePuey EG, Heller GV, Wolinsky DA. American Society of Nuclear Cardiology and Society of Nuclear Medicine and Molecular Imaging joint position statement on the clinical indications for myocardial perfusion PET. J Nucl Cardiol. 2016;23(5):1227-1231. Can be accessed on line at: https://www.asnc.org/files/Guidelines%20and%20Quality/ASNCandSNMMIJointPETPositionPaper2016.pdf 9. Bateman TM, Heller GV, McGhie AI, et al. Diagnostic accuracy of rest/stress ECG-gated Rb-82 myocardial perfusion PET: comparison with ECG-gated Tc-99m sestamibi SPECT. J Nucl Cardiol. 2006;13(1):24-33. 10. Merhige. 11. Schwaiger M, Ziegler S, Nekolla SG. PET/ CT: challenge for nuclear cardiology. J Nucl Med. 2005;46(10):1664-1678. 12. Yoshinaga K, Chow BW, Williams K, et al. What is the prognostic value of myocardial perfusion imaging using rubidium-82 positron emission tomography. J Am Coll Cardiol. 2006;48(5):1029-1039. 13. Benthamizhchelvan S, Bravo PE, Esaias C, et al. Human biodistribution and radiation dosimetry of 82Rb. J Nucl Med. 2010;51(10):1592-1599. 14. Senthamizhchelvan S, Bravo PE, Lodge MA, et al. Radiation dosimetry of 82Rb in humans under pharmacologic stress. J Nucl Med. 2011;52(3):485-491. 15. Schleipman AR, Castronovo FP Jr, Di Carli MF, Dorbala S. Occupational radiation dose associated with Rb-82 myocardial perfusion positron emission tomography imaging. J Nucl Cardiol. 2006;13(3):378-384.