Provider coding & billing information

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Provider coding & billing information

A guide to coding & reimbursement for NovoSeven

®

_RT

2012-2013

Models are for illustrative purposes only.

Includes new ICD-9 codes for acquired

hemophilia and ICD-10 codes for 2013

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Please see additional Important Safety Information on pages 19 and 20. Please see accompanying Prescribing Information.

Indications and Usage

NovoSeven®_{RT (Coagulation Factor VIIa [Recombinant]}

Room Temperature Stable) is indicated for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to FVIII or FIX and in patients with acquired

hemophilia; prevention of bleeding in surgical interventions or invasive procedures in hemophilia A or B patients with inhibitors to FVIII or FIX and in patients with acquired

hemophilia; treatment of bleeding episodes in patients with congenital FVII deficiency and prevention of bleeding in surgical interventions or invasive procedures in patients with congenital FVII deficiency.

Important Safety Information

Warning: Serious thrombotic adverse events are associated with the use of NovoSeven®_{RT outside labeled indications.}

Arterial and venous thrombotic and thromboembolic events following administration of NovoSeven®_{RT have been}

reported during postmarketing surveillance. Clinical studies have shown an increased risk of arterial thromboembolic adverse events with NovoSeven®_{RT when administered}

outside the current approved indications. Fatal and non-fatal thrombotic events have been reported. Discuss the risks and explain the signs and symptoms of thrombotic and thromboembolic events to patients who will receive NovoSeven®_{RT. Monitor patients for signs or symptoms of}

activation of the coagulation system and for thrombosis. Safety and efficacy of NovoSeven®_{RT has not been}

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2 Introduction

The lives of healthcare providers can be hectic. That’s why Novo Nordisk aims to bring ease to the administration challenges of insurance reimbursement—so you can spend more time providing quality care.

This guide is designed to help you secure maximum

reimbursement for NovoSeven®_{RT by carefully navigating}

the coding and billing process. It includes:

• Coding NovoSeven®_{RT reimbursement claims}

• Applying for prior authorization

•Reimbursement considerations

• Responding to denial of coverage

4 Coding for NovoSeven

®

_RT

Note: For the purposes of this guide, the term ‘provider office’ will refer to any setting in which NovoSeven®_{RT is}

administered (hospital, hemophilia treatment center, etc).

Coverage

Bypassing agents such as NovoSeven®_{RT can be covered as}

a medical benefit through a health plan, or a pharmacy or specialty benefit through a drug plan.

Medicare, Medicaid, and almost all private insurance plans should cover NovoSeven®_{RT for patients who meet}

coverage criteria. Some insurers may require a prior authorization or ask for additional information before making a coverage decision.

Coverage criteria for Medicare and Medicaid are dictated by federal and state requirements. Coverage rules and payment methods vary by insurer and type of healthcare provider. For more information regarding reimbursement for NovoSeven®_{RT, refer to page 12.}

Claim forms

There are 2 forms that may be used to submit a claim for NovoSeven®_{RT reimbursement. The type of form depends on}

the provider office administering treatment:

Form Provider office

HCFA 1450 (UB-04) Hospital, hemophilia treatment center, _{other specialty clinic} HCFA 1500 Physician’s office, home health agency

To secure reimbursement for NovoSeven®_{RT, a properly}

coded claim form must be submitted. Claims must include the following:

• Patient diagnosis codes: these codes have been revised recently to better facilitate reimbursement for patients with hemophilia - see Diagnosis codes, pages 5 and 6

• Physician procedure codes

• Drug codes

• Units of NovoSeven®_{RT used (micrograms}

or milligrams)

• Revenue codes (if applicable)

The next several pages contain reimbursement codes that are applicable to NovoSeven®_{RT. However, many insurers}

have unique coding and claims submission requirements. Check individual plan requirements before coding and submitting a claim form.

For guidance inputting codes on your claim form, refer to the fold-out page inside the back cover of this guide

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Please see Important Safety Information on pages 19 and 20.

Please see accompanying Prescribing Information.

Diagnosis codes

Currently, claim forms must include an International Classification of Diseases, Ninth Revision, Clinical

Modification (ICD-9-CM) diagnosis code. Prior ICD-9-CM versions had no specific code for acquired hemophilia. Pursuant to the efforts of a partnership including Dr. Craig Kessler of Georgetown University Medical Center, Dr. Ellinor Peerschke of Mount Sinai Hospital and Medical Center, and Novo Nordisk, the ICD-9-CM codes have been revised to address patients with acquired hemophilia.

These specifications will carry over into the next generation of ICD-10-CM codes, scheduled to become effective on October 1, 2013.

Other congenital factor deficiencies, including Factor VII, continue to be grouped in ICD-9-CM and ICD-10-CM coding. At right are the new ICD-9-CM codes that may be most appropriate for patients treated with NovoSeven®_RT:

ICD-9-CM

diagnosis code Description

286.0* Hemophilia A (Factor VIII deficiency) 286.1* Hemophilia B (Factor IX deficiency) 286.2 Hemophilia C (Factor XI deficiency) 286.3* Other hereditary factor deficiency _{(including Factor VII)}

286.52*

Acquired hemophilia

• Autoimmune hemophilia

• Autoimmune inhibitors to clotting factors

• Secondary hemophilia

286.53 Antiphospholipid antibody with hemorrhagic disorder

• Lupus anticoagulant (LAC) with hemorrhagic disorder

• Systemic lupus erythematosus (SLE) inhibitor with hemorrhagic disorder

• Excludes:

- antiphospholipid antibody, finding without diagnosis (795.79)

- antiphospholipid antibody syndrome (289.81) - antiphospholipid antibody with

hypercoagulable state (289.81) - LAC finding without diagnosis (795.79) - LAC with hypercoagulable state (289.81) - SLE inhibitor finding without diagnosis (795.79) - SLE inhibitor with hypercoagulable state (289.81) *NovoSeven®_{RT indication.}

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ICD-9-CM

286.59 Other hemorrhagic disorder due to intrinsic circulating anticoagulants, antibodies, or inhibitors • Antithrombinemia • Antithromboplastinemia • Antithromboplastino genemia • Hyperheparinemia • Increase in: - anti-II (prothrombin) - anti-VIIIa - anti-IXa

Diagnosis codes (cont’d)

If none of these codes specifically apply to your patient, select the code that best describes your patient’s condition. Also consider diagnosis codes that are specific to the

hemorrhage site.

A new generation of International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) diagnosis codes are scheduled to go into effect on October 1, 2013. These codes will carry over the new improved hemophilia-related classifications recently created for ICD-9-CM.

6

For a quick-reference card of NovoSeven®_{RT codes, refer}

to the fold-out page inside the back cover of this guide

ICD-10-CM

D66* Hemophilia A (Factor VIII deficiency) D67* Hemophilia B (Factor IX deficiency) D68.1 Hemophilia C (Factor XI deficiency) D68.2* Other hereditary factor deficiency _{(including Factor VII)} D68.31

Hemorrhagic disorder due to intrinsic circulating anticoagulants, antibodies, or inhibitors D68.311 Acquired hemophilia • Autoimmune hemophilia • Autoimmune inhibitors to clotting factors • Secondary hemophilia

D68.312 Antiphospholipid antibody with hemorrhagic disorder

D68.318

Other hemorrhagic disorder due to intrinsic circulating anticoagulants, antibodies, or inhibitors

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Physician procedure codes

When NovoSeven®_{RT is administered as part of a procedure}

performed by a physician, a Current Procedural Terminology (CPT-4)* code must be included.

The following procedure codes may apply to administration of NovoSeven®_RT:

Drug codes

Use the following Healthcare Common Procedural Coding System (HCPCS) code to bill for NovoSeven®_RT:

Procedure CPT code Description

Infusion

of drug 96364

Therapeutic, prophylactic, or diagnostic injection of drug; intravenous, single or initial substance (specify NovoSeven®_RT)

Infusion

of drug 96369

Unlisted therapeutic, prophylactic, or diagnostic injection or infusion (specify NovoSeven®_RT)

Drug HCPCS

code Description

NovoSeven®_RT _J7189

Factor VIIa (Coagulation Factor, Recombinant) per 1-µg equivalent

* 5-digit CPT codes, nomenclature, and other data are copyright 2001 of the American Medical Association (AMA). All rights reserved. No fee schedules, basic unit, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein.

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8 Additional codes for hospital-based

procedures

If NovoSeven®_{RT is administered in the hospital inpatient}

or outpatient setting, claims should also include ICD-9-CM procedure codes and revenue codes as described below. Note: These codes should be used on form HCFA-1450 (UB-04) only.

The ICD-9-CM procedure codes most commonly used for the administration of NovoSeven®_{RT are:}

Insurers may require NovoSeven®_{RT to be billed with one of}

the following revenue codes to cover supplies and services provided in the inpatient and outpatient settings:

Hospital-based procedure ICD-9-CM procedure code Description Infusion of drug 99.06 Transfusion of coagulation factors/transfusion of antihemophilic factor Infusion of drug 99.29 Injection or infusion of other therapeutic or prophylactic substance Charge

category Revenue code Description

Pharmacy 250 Pharmacy: general classification

Hospital blood

service 380 Blood: general classification

Hospital blood

service 387 Blood: other derivatives

Drugs that require specific identifica-tion 636

Use of this code is reserved for drugs that require specific identification. This code is necessary when submitting Medicare claims for NovoSeven®_{RT provided}

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Avoiding coding errors

The coding instructions on pages 4-8 should help limit the number of coding errors associated with NovoSeven®_RT

reimbursement claims.

Use these additional tips to double-check all claim forms before submitting:

• Ensure that HCPCS drug codes match up with diagnosis codes

— The NovoSeven®_{RT drug code (J7189) usually requires}

an ICD-9-CM code of 286.X (ICD-10-CM codes will be D66-D68.X)

• Ensure that HCPCS drug codes have an associated procedure code

• Be aware of codes that have time components and other requirements associated with them

• Get any questions regarding coding or time components answered at the time of prior authorization

• Document the answers to your questions to avoid coding errors in the future

The next generation of ICD codes (ICD-10-CM) are scheduled to take effect on October 1, 2013

Billing and coding are extremely important administrative issues for hospitals, clinics, and physicians. To help ease the challenges associated with the billing and coding process, stay abreast of procedure codes associated with healthcare charges.

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10 Prior authorization

Prior authorization is a process used by insurers to validate that there is a medical need for a specific product or service. When prior authorization is required, additional information must be provided to determine if the insurer will agree to coverage.

Prior authorization may be required for NovoSeven®_RT,

depending on the terms of the patient’s insurance coverage.

When contacting your patient’s insurer for prior

authorization, have the following information available:

• Patient’s name

• Insurance identification number/group number

• Patient’s date of birth

• Physician’s provider number (if physician is a participating provider)

• Date(s) of service

• ICD-9-CM/ICD-10-CM and CPT codes for the procedure(s) performed

See pages 5-8 for codes applicable to NovoSeven®_RT

• HCPCS and NDC codes for the drug(s) administered

See page 7 for the HCPCS code applicable to NovoSeven®_RT

Medical/utilization review

Prior authorization is usually a simple process, requiring only a phone call, fax, or form.

However, sometimes an insurer may request additional information for a medical/utilization review. The medical/ utilization review department will then review the requested information to ensure one of the following requirements for NovoSeven®_{RT is met:}

• Treatment of bleeding episodes in hemophilia A and B with inhibitors

Patients with inhibitors to Factor VIII or Factor IX, or those with acquired hemophilia

• Prevention of bleeding in surgical interventions or invasive procedures

Patients with inhibitors to Factor VIII or Factor IX, or those with acquired hemophilia

• Treatment of bleeding episodes in congenital Factor VII deficiency

Patients with congenital/hereditary Factor VII deficiency, and prevention of bleeding in surgical interventions or invasive procedures in those patients

Failure to obtain prior authorization when required may result in denied claims for the provider office and/or higher out-of-pocket costs for the patient Prior authorization

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12 Reimbursement considerations

Hospital inpatient

Medicare

In addition to reimbursement for hospital services, Medicare provides a separate reimbursement for blood clotting factors administered in the hospital inpatient setting.

These clotting factors are reimbursed at 106% of the average sale price (ASP).

To secure payment, inpatient Medicare claims for NovoSeven®_{RT must contain the following:}

• Patient diagnosis code

• Revenue code (NovoSeven®_{RT revenue code: 636)}

• Drug code (NovoSeven®_{RT drug code: J7189)}

Medicaid and private insurance plans

Some Medicaid agencies and many private insurance plans also provide separate reimbursements for clotting factors in the inpatient setting. Those payments are typically based on the published average wholesale price (AWP).

Coding requirements may vary by insurer.

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Hospital outpatient/hemophilia

treatment center

Medicare

Under Medicare’s outpatient prospective payment system (OPPS), hospitals receive fixed payments for outpatient services provided. However, clotting factors are considered separately payable drugs and are reimbursed separately at a percentage of ASP.

Additionally, clotting factors covered by Medicare Part B are subject to a furnishing fee that is reimbursed on top of the ASP-based payment.

Private insurance plans

Most private insurance plans reimburse for outpatient services based on charges, discounted charges, costs, or per diem payments.

Some private insurance plans will reimburse for NovoSeven®_{RT in addition to payment for services}

provided. Refer to the individual plan for specific terms and conditions.

Infusion at home

Most Medicare, Medicaid, and private insurance plans reimburse for clotting factors used in the home.

Every plan is different. Carefully check each plan before advising a patient on reimbursements for clotting factors administered in the home.

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14 Reimbursement tips

Submitting accurate reimbursement claims can help limit the number of delayed and denied claims. Use the tips below to help ensure the accuracy of claims for NovoSeven®_RT:

• Benefit plans vary, so always be sure to verify each patient’s insurance benefit

• Always verify prior authorization requirements with insurers

— Confirm the preferred method for claims submission — Confirm where the claim should be submitted — Determine the amount of time required to process

prior authorization

• File claims promptly and be sure all coding is accurate

• Consider supplying a letter of medical necessity

• Follow up with insurers to encourage timely claims processing

• Monitor and identify reasons for denied claims through explanations of benefits

• Document all communications with insurers regarding prior authorization and denied claims

• Be familiar with the appeals process and be prepared to provide supporting documentation

For further assistance, call 1-877-NOVO-777 (1-877-668-6777) or talk to your NovoSeven®_{RT representative.}

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16 Appeals and denials

When a reimbursement claim is denied, an appeal may be filed to persuade the insurance company to reverse its decision and provide coverage. The first step to filing an appeal is to determine the reason it was denied.

Reviewing the explanation of benefits

After a claim is submitted to the patient’s insurance plan, the provider office will receive an explanation of benefits, which contains information regarding approved and denied payments.

Review the explanation of benefits to determine the reason for the denial; it will include a coded description of the reason for the denial.

Common causes of denied claims from private insurers include:

• Failure to obtain prior authorization

• Improper coding or missing information (patient ID number, signatures, etc)

• Lack of documentation to support medical necessity

• Confusion around dosing (submitting dosages in incorrect units)

If you determine that the denial was not due to a claim submission error, you may need to resubmit the claim with materials to document medical necessity.

To help limit denied claims, refer to page 9 for tips on avoiding coding errors

If the cause of the denial is still unclear after reviewing the explanation of benefits, call the insurer for

more information.

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Writing an appeal letter

When filing an appeal, it may be necessary to include an appeal letter to validate the patient’s medical necessity. To streamline your appeals process, Novo Nordisk offers several pre-written appeal letters for responding to denial of NovoSeven®_{RT coverage.}

Refer to page 18 to see these sample letters, which you can use as a guide when you are writing your own appeal letters.

Appeals tips

Proper and complete documentation is essential to a successful appeal. Use the following tips to help navigate the appeals process:

• Be familiar with the rules and appropriate procedures to follow

• Document events as they occur

• Refer to the sequence of events when writing a summary of the situation

• Communicate clearly and precisely

• Don’t give up—if the appeal is not reviewed to your satisfaction, continue to pursue it

An insurer that receives a number of appeals for the same reason may re-evaluate its process to align with new customer needs

For questions regarding denied claims and additional help with the appeals process, call 1-877-NOVO-777 (1-877-668-6777).

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18

[Office Letterhead Provider Name and Address Date

Payer Name Payer Address

Attn: Appeals Department Re: Patient Name

Policy ID/Group Number Date of Service Disputed Amount] Dear Sir/Madam:

The claim for our patient referenced above was denied on [date]. The reason for denial, as indicated on the Report to Provider, was [list reason(s) for denial]. I disagree with this determination and request an appeal of the denied claim.

NovoSeven®_{RT is indicated for the treatment of bleeding episodes in hemophilia}

A or B patients with inhibitors to FVIII or FIX and in patients with acquired hemophilia; prevention of bleeding in surgical interventions or invasive procedures in hemophilia A or B patients with inhibitors to FVIII or FIX and in patients with acquired hemophilia; treatment of bleeding episodes in patients with congenital FVII deficiency and prevention of bleeding in surgical interventions or invasive procedures in patients with congenital FVII deficiency.

[Patient name] was treated with NovoSeven®_{RT for [indication/date of service].}

In my opinion, NovoSeven®_{RT was medically necessary for the treatment of my}

patient’s condition. Enclosed is clinical documentation supporting the use of NovoSeven®_{RT. I request that you reconsider and reverse the claim denial.}

Sincerely, [Physician Name]

Response letter for claim denial after infusion

Sample appeal letters

[Office Letterhead Provider Name and Address Date

Payer Name Payer Address

Attn: Appeals Department Re: Patient Name

Policy ID/Group Number Precertification Denial] Dear Sir/Madam:

The precertification for our patient referenced above was denied on [date]. The reason for denial, as indicated on the Report to Provider, was [list reason(s) for denial]. I disagree with this determination and request an appeal of the denied precertification.

NovoSeven®_{RT is indicated for the treatment of bleeding episodes in hemophilia}

A or B patients with inhibitors to FVIII or FIX and in patients with acquired hemophilia; prevention of bleeding in surgical interventions or invasive procedures in hemophilia A or B patients with inhibitors to FVIII or FIX and in patients with acquired hemophilia; treatment of bleeding episodes in patients with congenital FVII deficiency and prevention of bleeding in surgical interventions or invasive procedures in patients with congenital FVII deficiency.

In my opinion, NovoSeven®_{RT is medically necessary for the treatment of my}

patient’s condition. Enclosed is clinical documentation supporting my choice of NovoSeven®_{RT. I request that you reconsider and reverse the precertification denial.}

Sincerely, [Physician Name]

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Indications and Usage

NovoSeven®_{RT (Coagulation Factor VIIa [Recombinant]}

Room Temperature Stable) is indicated for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to FVIII or FIX and in patients with acquired

hemophilia; prevention of bleeding in surgical interventions or invasive procedures in hemophilia A or B patients with inhibitors to FVIII or FIX and in patients with acquired

hemophilia; treatment of bleeding episodes in patients with congenital FVII deficiency and prevention of bleeding in surgical interventions or invasive procedures in patients with congenital FVII deficiency.

Important Safety Information

Warning: Serious thrombotic adverse events are associated with the use of NovoSeven®_{RT outside labeled indications.}

Arterial and venous thrombotic and thromboembolic events following administration of NovoSeven®_{RT have been}

reported during postmarketing surveillance. Clinical studies have shown an increased risk of arterial thromboembolic adverse events with NovoSeven®_{RT when administered}

outside the current approved indications. Fatal and non-fatal thrombotic events have been reported. Discuss the risks and explain the signs and symptoms of thrombotic and thromboembolic events to patients who will receive NovoSeven®_{RT. Monitor patients for signs or symptoms of}

activation of the coagulation system and for thrombosis. Safety and efficacy of NovoSeven®_{RT has not been}

established outside the approved indications. Thrombotic events following the administration of NovoSeven®_{RT occurred in 0.28% of bleeding episodes}

treated, with the incidence in acquired hemophilia of 4% and in hemophilia patients of 0.20% in clinical trials within the approved indications. Fatal and non-fatal thrombotic events have been identified through postmarketing surveillance following NovoSeven®_{RT use for each of the}

approved indications.

Please see additional Important Safety Information on page 20. Please see accompanying Prescribing Information.

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1a. INSURED’S I.D. NUMBER (FOR PROGRAM IN ITEM 1) 4. INSURED’S NAME (Last Name, First Name, Middle Initial) 7. INSURED’S ADDRESS (No., Street)

CITY STATE

ZIP CODE TELEPHONE (INCLUDE AREA CODE) 11. INSURED’S POLICY GROUP OR FECA NUMBER a. INSURED’S DATE OF BIRTH b. EMPLOYER’S NAME OR SCHOOL NAME c. INSURANCE PLAN NAME OR PROGRAM NAME d. IS THERE ANOTHER HEALTH BENEFIT PLAN? 13. INSURED’S OR AUTHORIZED PERSON’S SIGNATURE I authorize

payment of medical benefits to the undersigned physician or supplier for services described below.

SEX

F

HEALTH INSURANCE CLAIM FORM

OTHER 1. MEDICARE MEDICAID CHAMPUS CHAMPVA

READ BACK OF FORM BEFORE COMPLETING & SIGNING THIS FORM.

12. PATIENT’S OR AUTHORIZED PERSON’S SIGNATURE I authorize the release of any medical or other information necessary to process this claim. I also request payment of government benefits either to myself or to the party who accepts assignment below.

SIGNED DATE

ILLNESS (First symptom) OR INJURY (Accident) OR PREGNANCY(LMP)

MM DD YY 15. IF PATIENT HAS HAD SAME OR SIMILAR ILLNESS.GIVE FIRST DATE MM DD YY 14. DATE OF CURRENT:

17. NAME OF REFERRING PHYSICIAN OR OTHER SOURCE 19. RESERVED FOR LOCAL USE

21. DIAGNOSIS OR NATURE OF ILLNESS OR INJURY. (RELATE ITEMS 1,2,3 OR 4 TO ITEM 24E BY LINE) 17a. I.D. NUMBER OF REFERRING PHYSICIAN

From MM DD YY MM DD YYTo 1 2 3 4 5 6

25. FEDERAL TAX I.D. NUMBER SSN EIN 26. PATIENT’S ACCOUNT NO. 27. ACCEPT ASSIGNMENT?_{(For govt. claims, see back)} 31. SIGNATURE OF PHYSICIAN OR SUPPLIER

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

SIGNED DATE

32. NAME AND ADDRESS OF FACILITY WHERE SERVICES WERE RENDERED (If other than home or office)

SIGNED MM DD YY FROM TO FROM TO MM DD YY MM DD YY MM DD YY MM DD YY

CODE ORIGINAL REF. NO.

$ CHARGES EMG COB RESERVED FORLOCAL USE

28. TOTAL CHARGE 29. AMOUNT PAID 30. BALANCE DUE

$ $ $

33. PHYSICIAN’S, SUPPLIER’S BILLING NAME, ADDRESS, ZIP CODE & PHONE #

PIN# GRP#

PICA PICA

2. PATIENT’S NAME (Last Name, First Name, Middle Initial) 5. PATIENT’S ADDRESS (No., Street)

CITY STATE

ZIP CODE TELEPHONE (Include Area Code) 9. OTHER INSURED’S NAME (Last Name, First Name, Middle Initial) a. OTHER INSURED’S POLICY OR GROUP NUMBER b. OTHER INSURED’S DATE OF BIRTH c. EMPLOYER’S NAME OR SCHOOL NAME d. INSURANCE PLAN NAME OR PROGRAM NAME

(APPROVED BY AMA COUNCIL ON MEDICAL SERVICE 8/88)

YES NO

( )

If yes, return to and complete item 9 a-d.

16. DATES PATIENT UNABLE TO WORK IN CURRENT OCCUPATION 18. HOSPITALIZATION DATES RELATED TO CURRENT SERVICES 20. OUTSIDE LAB? $ CHARGES 22. MEDICAID RESUBMISSION 23. PRIOR AUTHORIZATION NUMBER MM DD YY

CARRIER

PATIENT

AND INSURED INFORMATION

PHYSICIAN OR SUPPLIER INFORMATION M F YES NO YES NO 1. 3. 2. 4.

DATE(S) OF SERVICE Type of Service Place

of Service

PROCEDURES, SERVICES, OR SUPPLIES (Explain Unusual Circumstances) CPT/HCPCS MODIFIER DIAGNOSIS CODE PLEASE DO NOT STAPLE IN THIS AREA F M SEX MM DD YY YES NO YES NO YES NO PLACE (State) GROUP

HEALTH PLAN FECABLK LUNG

Single Married Other 3. PATIENT’S BIRTH DATE 6. PATIENT RELATIONSHIP TO INSURED 8. PATIENT STATUS

10. IS PATIENT’S CONDITION RELATED TO: a. EMPLOYMENT? (CURRENT OR PREVIOUS) b. AUTO ACCIDENT? c. OTHER ACCIDENT? 10d. RESERVED FOR LOCAL USE

Employed Full-Time Part-Time Student Student Self Spouse Child Other (Medicare #) (Medicaid #) (Sponsor’s SSN) (VA File #) (SSN or ID) (SSN) (ID)

( ) M SEX DAYS OR UNITS EPSDT Family Plan F G H I J K 24. A B C D E

PLEASE PRINT OR TYPE FORM HCFA-1500 (12-90), FORM RRB-1500, FORM OWCP-1500 APPROVED OMB-0938-0008 __ __ __ __ 1 2 4 TYPE OF BILL FROM THROUGH 5 FED. TAX NO.

a b c d DX ECI 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 A B C A B C D E F G H I J K L M N O P Q a b c a b c a b c d

ADMISSION CONDITION CODES DATE

OCCURRENCE OCCURRENCE OCCURRENCE OCCURRENCE SPAN OCCURRENCESPAN CODE DATE CODE CODE CODE DATE CODE THROUGH

VALUE CODES VALUECODES VALUE CODES CODE AMOUNT CODE AMOUNT CODE AMOUNT

TOTALS

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

FIRST

c. CODE DATE d. DATE e. OTHER PROCEDURE NPI

FIRST NPI b LAST FIRST c NPI d LAST FIRST UB-04 CMS-1450 7

10 BIRTHDATE 11 SEX 12 13 HR 14 TYPE 15 SRC DATE 16DHR 18 19 20 FROM 21 22 23 25 26 27 28 CODE FROM DATE OTHER PRV ID

THE CERTIFICATIONS ON THE REVERSE APPLY TO THIS BILL AND ARE MADE A PART HEREOF. b . INFO BEN. CODE OTHER PROCEDURE THROUGH 29 ACDT 30 32 31 33 34 35 36 37 38 39 40 41

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

52 REL

51 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 CREATIONDATE 3a PAT. CNTL # 24 b. MED. REC. #

44 HCPCS / RATE / HIPPS CODE

PAGE OF

OMB APPROVAL PENDING

e a

8 PATIENT NAME

50 PAYER NAME

63 TREATMENT AUTHORIZATION CODES

6 STATEMENT COVERS PERIOD 9 PATIENT ADDRESS 17STAT STATE DX REASON DX 71 PPS CODE QUAL LAST LAST National Uniform Billing Committee NUBC™ 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 © 2005 NUBC F245-367-000 _RESET

ICD-9-CM*_{diagnosis code}

Field 21 and 24E Revenue codeField 42 HCPCS drug code (J7189) _{and CPT procedure code} Field 44 HCPCS drug code (J7189) Field 24D 1. CPT procedure code Field 24D ICD-9-CM *_{procedure code} Field 74

Field 66

67

20 Important Safety Information (cont’d)

Patients with disseminated intravascular coagulation (DIC), advanced atherosclerotic disease, crush injury, septicemia, or concomitant treatment with activated or nonactivated prothrombin complex concentrates (aPCCs/PCCs) have an increased risk of developing thrombotic events in association with NovoSeven®_{RT treatment. Caution should be exercised}

when administering NovoSeven®_{RT to patients with an}

increased risk of thromboembolic complications. These include, but are not limited to, patients with a history of coronary heart disease, liver disease, post-operative immobilization, elderly patients, and neonates. In each of these situations, the potential benefi t of treatment with NovoSeven®_{RT should be weighed against the risk}

of these complications.

NovoSeven

®

_{RT reimbursement codes}

Quick-reference card

ICD-9-CM diagnosis codes

286.0 - Hemophilia A (Factor VIII defi ciency) 286.1 - Hemophilia B (Factor IX defi ciency)

286.3 - Other factor defi ciency (includes Factor VII)

286.52 - Acquired, autoimmune, or secondary hemophilia

D66 - Hemophilia A (Factor VIII defi ciency) D67 - Hemophilia B (Factor IX defi ciency)

D68.2 - Other factor defi ciency (includes Factor VII)

D68.311 - Acquired, autoimmune, or secondary hemophilia

CPT-4 codes

96364 - Therapeutic, prophylactic, or diagnostic injection of drug; intravenous, single or initial substance

96369 - Unlisted therapeutic, prophylactic, or diagnostic injection or infusion

ICD-9-CM procedure codes (hospital only)

99.06 - Transfusion of coagulation factors/transfusion of antihemophilic factor

99.29 - Injection or infusion of other therapeutic or prophylactic substance

Revenue codes (hospital only) 250 - Pharmacy: general classifi cation 380 - Blood: general classifi cation 387 - Blood: other derivatives

636 - NovoSeven®_{RT drug identifi cation code}

for hospital Medicare claims

NovoSeven®_{RT HCPCS code: J7189}

Development of antibodies against FVII has been reported in FVII-defi cient patients after treatment with NovoSeven®

RT. FVII-defi cient patients should be monitored for prothrombin time (PT) and FVII coagulant activity before and after administration of NovoSeven®_RT.

Use with caution in patients with known hypersensitivity to NovoSeven®_{RT, its components, or mouse, hamster, or}

bovine proteins.

Laboratory coagulation parameters (PT/INR, aPTT, FVII:C) have shown no direct correlation to achieving hemostasis. In clinical trials, the most common adverse events of NovoSeven®_{RT therapy are pyrexia, hemorrhage,}

injection site reaction, arthralgia, headache, hypertension, hypotension, nausea, vomiting, pain, edema, and rash.

HCFA 1500

HCFA 1450 (UB-04)

(22)

the reimbursement codes that apply to NovoSeven®_{RT. It is}

perforated and removable for your convenience.

(1-877-668-6777)

NovoSeven®_{is a registered trademark of Novo Nordisk Health Care AG.}

(23)

CITY STATE

SEX

F

SIGNED DATE

$ $ $

PIN# GRP#

PICA PICA

CITY STATE

YES NO

( )

CARRIER

PATIENT

of Service

TOTALS

FIRST

52 REL

PAGE OF

e a

8 PATIENT NAME

50 PAYER NAME

Field 21 and 24E Revenue codeField 42 HCPCS drug code (J7189) _{and CPT procedure code} Field 44 HCPCS drug code (J7189) Field 24D 1. CPT procedure code Field 24D ICD-9-CM *_{procedure code} Field 74

Field 66

67

20 Important Safety Information (cont’d)

NovoSeven

®

_{RT reimbursement codes}

Quick-reference card

CPT-4 codes

bovine proteins.

HCFA 1500

HCFA 1450 (UB-04)

(24)

CITY STATE

SEX

F

SIGNED DATE

$ $ $

PIN# GRP#

PICA PICA

CITY STATE

YES NO

( )

CARRIER

PATIENT

of Service

TOTALS

FIRST

52 REL

PAGE OF

e a

8 PATIENT NAME

50 PAYER NAME

Field 21 and 24E Field 42 _{and CPT procedure code} Field 44 HCPCS drug code (J7189) Field 24D 1. CPT procedure code Field 24D ICD-9-CM *_{procedure code} Field 74

Field 66

67

Important Safety Information (cont’d)

CPT-4 codes

bovine proteins.

(25)

Flip open this page for direction on where to input codes for forms HCFA 1500 and HCFA 1450 (UB-04).

Also, refer to the attached Quick-reference card to quickly find the reimbursement codes that apply to NovoSeven®_{RT. It is}

perforated and removable for your convenience.

For questions or assistance regarding NovoSeven

®

_RT

billing, coding, or reimbursement, call 1-877-NOVO-777

(1-877-668-6777)

NovoSeven®_{is a registered trademark of Novo Nordisk Health Care AG.}

Provider coding & billing information