A GUIDE TO SPINRAZA REIMBURSEMENT€¦ · access challenges. The RDRM is responsible for helping...

INDICATIONSPINRAZA® (nusinersen) is indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients.

SELECTED IMPORTANT SAFETY INFORMATIONCoagulation abnormalities and thrombocytopenia, including acute severe thrombocytopenia, have been observed after administration of some antisense oligonucleotides. Patients may be at increased risk of bleeding complications.

Please see additional Important Safety Information on page 75 and accompanying full Prescribing Information.

IMPORTANT INFORMATION TO HELP NAVIGATE THE ACCESS AND REIMBURSEMENT PROCESS

A GUIDE TO SPINRAZA REIMBURSEMENT

https://www.spinraza-hcp.com/content/dam/commercial/specialty/spinraza/hcp/en_us/pdf/spinraza-prescribing-information.pdf

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SELECTED IMPORTANT SAFETY INFORMATIONIn the sham-controlled studies for patients with infantile-onset and later-onset SMA, 24 of 146 SPINRAZA-treated patients (16%) with high, normal, or unknown platelet count at baseline developed a platelet level below the lower limit of normal, compared to 10 of 72 sham-controlled patients (14%). Two SPINRAZA-treated patients developed platelet counts <50,000 cells per microliter, with the lowest level of 10,000 cells per microliter recorded on study day 28.


INTRODUCTIONWELCOMESPINRAZA is a US Food and Drug Administration (FDA)–approved treatment indicated for spinal muscular atrophy (SMA) in pediatric and adult patients.1 Biogen is committed to providing detailed information to assist in obtaining reimbursement for SPINRAZA, drug administration, and related ancillary services. We have developed this guide in conjunction with our support service, SMA360°*, to provide you with the information you need to help with the reimbursement process for SPINRAZA. SMA360° offers individualized support to help your patients and their families throughout the treatment process.The information in this guide is intended for informational purposes only and does not represent legal or billing advice. For specific guidance in this area, consult your own legal/billing advisor and billing/coding specialist because it remains your responsibility to ensure the accuracy of the claims your office submits. The content herein is based on information current as of April 2019, and may have changed.Any product, ancillary supplies, or services received free of charge cannot be billed to third-party payers because doing so could be a violation of federal and/or state laws and/or third-party–payer requirements.

SPINRAZA SUPPORT AND RESOURCESSMA360° is here for your patientsBiogen’s SMA360° program offers comprehensive and individualized support to help patients with SMA and their families navigate nonmedical barriers to access. Services include logistical assistance, product education, insurance benefits investigation, and financial assistance. A complete list of the SMA360° offerings can be found at SPINRAZA-hcp.com/support. SMA is a highly variable disease and each patient will have his or her own unique set of needs. Your patients or their caregivers may feel like they could use a helping hand. Biogen has a team that will be there for them throughout the SPINRAZA journey. Please remember that you should be the primary resource for any questions related to SMA and SPINRAZA. Additional information about the services provided by SMA360° are included in this guide.

* SMA360° services from Biogen are available only to those who have been prescribed SPINRAZA. SMA360° is intended for US residents only.


https://www.spinraza.com/en_us/home/patient-support-services/biogen-support-program.html

https://www.spinraza.com/en_us/home/patient-support-services/biogen-support-program.html

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SELECTED IMPORTANT SAFETY INFORMATIONRenal toxicity, including potentially fatal glomerulonephritis, has been observed after administration of some antisense oligonucleotides. SPINRAZA is present in and excreted by the kidney. In the sham-controlled studies for patients with infantile-onset and later-onset SMA, 71 of 123 SPINRAZA-treated patients (58%) had elevated urine protein, compared to 22 of 65 sham-controlled patients (34%).


SMA360° IS AVAILABLE TO ASSIST YOU

SMA360˚ team members, such as Rare Disease Reimbursement Managers (RDRMs), are available to assist your practice or site of care (SOC) by providing nonclinical education and support to help overcome access challenges.

The RDRM is responsible for helping you and your staff navigate the reimbursement and administrative processes for SPINRAZA.

The RDRM can help• Educate you and your staff on SPINRAZA procurement methods• Provide enhanced education on claims forms and coding/billing• Support your team’s interactions with health plans

RARE DISEASE REIMBURSEMENT MANAGER


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SELECTED IMPORTANT SAFETY INFORMATIONLaboratory testing and monitoring to assess safety should be conducted. Perform a platelet count, coagulation laboratory testing, and quantitative spot urine protein testing at baseline and prior to each dose of SPINRAZA and as clinically needed.Severe hyponatremia was reported in an infant treated with SPINRAZA requiring salt supplementation for 14 months.Cases of rash were reported in patients treated with SPINRAZA. SPINRAZA may cause a reduction in growth as measured by height when administered to infants, as suggested by observations from the controlled study. It is unknown whether any effect of SPINRAZA on growth would be reversible with cessation of treatment.


TABLE OF CONTENTS

Overview of the Reimbursement Process for SPINRAZA .......................................................6

Site-of-Care Considerations ......................................................................................................12

Investigating Benefits and Obtaining Authorization ............................................................18

Navigating Financial Assistance Options ...............................................................................35

Ordering SPINRAZA ..................................................................................................................40

Submitting Claims for SPINRAZA and Related Services ......................................................42

Medicare and SMA .....................................................................................................................61

Appendix .....................................................................................................................................72

• Sample SPINRAZA Start Form

• Sample SPINRAZA Copay Reimbursement Form

• Sample Letters of Medical Necessity

• Indication and Important Safety Information

• References


Keeley.Guillerme

Sticky Note

Unmarked set by Keeley.Guillerme

OVERVIEW OF THE REIMBURSEMENT PROCESS FOR SPINRAZA® (nusinersen)

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SELECTED IMPORTANT SAFETY INFORMATIONThe most common adverse reactions (≥20% of SPINRAZA-treated patients and ≥5% more frequently than in control patients) that occurred in the infantile-onset controlled study were lower respiratory infection and constipation. Serious adverse reactions of atelectasis were more frequent in SPINRAZA-treated patients (18%) than in control patients (10%). Because patients in this controlled study were infants, adverse reactions that are verbally reported could not be assessed. The most common adverse reactions that occurred in the later-onset controlled study were pyrexia, headache, vomiting, and back pain. Post-lumbar puncture syndrome has also been observed after the administration of SPINRAZA.


The following pages highlight key phases of the reimbursement process for SPINRAZA, including steps for starting a patient on therapy, as well as the information needed to submit a claim for reimbursement. Biogen is here to support you in the administration of SPINRAZA and timely submission of claims for adjudication.

This overview also informs various stakeholders involved in the care of patients receiving SPINRAZA. Your Biogen representative is available to assist you with any questions you may have about the process.

Benefits Investigation

and authorization

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Financial assistance

and insurance counseling

2

Patient treatment

scheduling

3

SPINRAZA administration and claim submission

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OVERVIEW OF THE REIMBURSEMENT PROCESS FOR SPINRAZA

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SELECTED IMPORTANT SAFETY INFORMATIONCoagulation abnormalities and thrombocytopenia, including acute severe thrombocytopenia, have been observed after administration of some antisense oligonucleotides. Patients may be at increased risk of bleeding complications. In the sham-controlled studies for patients with infantile-onset and later-onset SMA, 24 of 146 SPINRAZA-treated patients (16%) with high, normal, or unknown platelet count at baseline developed a platelet level below the lower limit of normal, compared to 10 of 72 sham-controlled patients (14%). Two SPINRAZA-treated patients developed platelet counts <50,000 cells per microliter, with the lowest level of 10,000 cells per microliter recorded on study day 28.


1Benefits

Investigation and authorization

A Benefits Investigation will help determine payer requirements based on the patient’s specific insurance plan benefits and the individualized care planA. Conduct a Benefits Investigation to help identify the following for SPINRAZA

administration and related services:• Coverage requirements, including precertification and/or medical

documentation; referral restrictions; and observation stay rules• Patient out-of-pocket (OOP) costs such as annual deductible vs amount met

to date, coinsurance and/or copay, and annual OOP maximum vs amount met to date

• State and/or network considerations — Participation status of the institution/practices and participating providers — Coverage restrictions and related exceptions process — OOP costs and related exceptions process — Secondary coverage coordination of benefits and reimbursement/payment

methodology from payers• Billing guidelines

— All documentation required to be submitted with the claim — National Drug Code (NDC) number reporting requirements

Approval of appropriate authorization(s) will provide payer coverage documentation before treatment initiationB. Contact the patient’s payer(s) directly to submit necessary documentation in order

to obtain authorization for SPINRAZA administration and related services, such as• PA/precertification form(s) and/or Letter of Medical Necessity • Out-of-state and/or out-of-network exception request and related

documentationC. If your authorization or exception request has been denied, locate the appeal

process and timeline in the denial letter. Contact the payer for instructions if they are not documented for you.

Your RDRM and Family Access Manager (FAM) are available to assist you with any questions you may have about this process.

For additional details, please refer to pages 18-33 of this guide.

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2Financial

assistance and

insurance counseling

The SMA360°* team will help connect the enrolled patient with appropriate financial assistance programs and provide insurance counseling, if neededA. The SMA360° team identifies appropriate financial assistance options

for eligible patients and assists with program enrollment and any related additional documentation†:• $0 Drug Copay Program• $0 Procedure Copay Program • Third-Party Funding Assistance

B. The SMA360° team offers insurance counseling to the patient’s family (if applicable), including• Summary of current insurance status• Review of potential alternative or supplemental sources of insurance

coverage (eg, Medicaid)

The SMA360° team can coordinate SPINRAZA administration logisticsC. The SMA360° team coordinates logistics with the patient’s family and

the SOC in preparation for the SPINRAZA administration visit



†Other programs may also be available for your patients.

COMPREHENSIVE SUPPORT FOR YOUR PATIENT IS AVAILABLE The SMA360° team will contact the enrolled patient’s family to help set expectations.We understand that for a caregiver or an individual living with SMA, life can be challenging. SMA360° is a support service from Biogen created to help families navigate the following areas of the treatment process with SPINRAZA:• Treatment logistics• Insurance and financial assistance

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3Patient

treatment scheduling

Schedule patient visit for SPINRAZA administration and make appropriate patient coordination arrangements A. Considerations

• Clinic visit for preprocedure exam, if needed• Intrathecal injection procedure scheduled with appropriate department• Notify hospital outpatient admission department of PA approval and

treatment date • Notify correct pharmacy department of PA approval and treatment date• Assist family with local overnight accommodations, if needed

CuraScript Specialty Distributor (SD) and Accredo Specialty Pharmacy (SP) are the exclusive authorized providers of SPINRAZAB. Order SPINRAZA from CuraScript SD or Accredo SP for delivery before the

scheduled patient visit:• The ordering process for SPINRAZA is through your facility’s pharmacy or

procurement department, as it would be for any other treatment

For additional details, please refer to page 40 of this guide.

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4SPINRAZA

administration and

claim submission

Administer SPINRAZA according to the Prescribing Information and individualized care plan• SPINRAZA is administered intrathecally by, or under the direction of,

healthcare professionals (HCPs) with experience performing lumbar punctures1

Following payer billing guidelines can facilitate claim processing and prompt payment A. Submit claim(s) to the patient’s payer(s) for SPINRAZA and related

services according to the billing guidelines identified through the Benefits Investigation


B. Schedule the next patient visit for SPINRAZA administration

Payer remittance monitoring will be critical for ensuring appropriate payment C. Monitor payer remittance for the submitted claim(s)D. Submit appeal with required documentation within filing timelines if the

claim is deniedE. Submit eligible OOP expenses to copay assistance or charitable funding

programs, if applicable


If you have any questions throughout this process, call SMA360°* at 1-844-4SPINRAZA (1-844-477-4672), Monday through Friday, from 8:30 AM to 8:00 PM ET, or contact your Biogen representative.


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SITE-OF-CARE CONSIDERATIONS

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Freestanding ambulatory surgical

center (ASC)

Inpatient hospital facility

Outpatient hospital-based facility*

Physician office

SITE-OF-CARE CONSIDERATIONSSeveral factors can influence the decision to administer SPINRAZA in a particular SOC. In order to ensure that the selected SOC can appropriately address patient needs, it is important that these factors are considered by the key stakeholders involved in patient care, including clinicians, administrators, and the patient’s family.

* Including off-campus clinic, on-campus facility, hospital-based ASC, and other outpatient outlets operated by a hospital.

Administration procedure and ancillary services

• Remember, SPINRAZA is administered intrathecally by, or under the direction of, HCPs with experience performing lumbar punctures

• Ensure the availability of clinical specialists who may need to be involved with SPINRAZA administration (eg, neurologist, anesthesiologist, radiologist)

• Prepare facility or doctor’s office with the necessary equipment (eg, sedation, lumbar puncture, ultrasound, fluoroscopy)

• If needed, ensure that logistical support is in place for the patient’s travel needs, depending on the distance between the SOC and the patient’s home

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SITE-OF-CARE CONSIDERATIONS (cont’d)

Payer reimbursement methodologyYour practice or facility should check directly with the patient’s payer(s) to verify specific coding and billing requirements.

Claim form CMS-1450/UB-04

See page 50 for unique billing considerations

and codes

Claim form CMS-1450/UB-04


and codes

Claim form CMS-1500


and codes

Claim form CMS-1500


and codes

Freestanding ASC

Freestanding ASC





Physician office

Physician office

Coordination of care

• Some patients may require additional monitoring and/or management in a hospital facility

• Ensure facility or doctor’s office can accommodate postinjection monitoring or admit or transfer patient for an inpatient stay

• Some patients may require an inpatient hospital stay for additional monitoring and/or management

• Inpatient administration of SPINRAZA may require a “carve-out” reimbursement agreement with the patient’s payer

• For insight about outpatient observation stays, see page 14

*Including off-campus clinic, on-campus facility, hospital-based ASC, and other outpatient outlets operated by a hospital.

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ADDITIONAL CONSIDERATIONS FOR PAYER REIMBURSEMENT• The facility services may be subject to some form of global payment rule or prospectively set

reimbursement rates (eg, global surgery payment, diagnosis-related group [DRG]–based payment, Enhanced Ambulatory Patient Groups [EAPG] payment)

• The payment for SPINRAZA may be separate or may be bundled within a prospectively set rate (eg, DRG-based rate, EAPG rate per diem rate)

OUTPATIENT OBSERVATION STAY INSIGHTS An observation stay is a hospital outpatient service that can be ordered by physicians to allow for medical evaluation and/or testing in order to determine whether a patient may require an inpatient stay. For example, if a patient experiences a complication after an outpatient surgery, his or her physician may order outpatient observation services to allow for additional monitoring after the postoperative recovery period.

The following are some features of an observation stay that could affect billing:

• A patient may occupy any bed in the hospital, but with outpatient status

• Outpatient status has important implications for hospital reimbursement and patient OOP costs

• The stay is typically completed within 24 to 48 hours, after which time the patient can be admitted as an inpatient or discharged

• Payers may cover different lengths of outpatient observation stays– Medicaid may allow up to 48 hours; other private payers may cover only 23 hours

• It is important to verify the requirements for an outpatient observation stay with each insurance carrier

SOC IMPLICATIONS FOR RELEVANT FINANCIAL ASSISTANCE PROGRAMSThere are several financial assistance programs available to eligible patients to support the administration of SPINRAZA. It is important to note to families that the SOC does not limit the patient’s eligibility for Biogen financial assistance programs. Biogen has several assistance programs for the SPINRAZA administration procedure and drug. See page 36 for more information. For more information on third-party funding assistance, contact SMA360˚* at 1-844-4SPINRAZA (1-844-477-4672), Monday through Friday, from 8:30 AM to 8:00 PM ET.


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PATIENT CARE CHECKLIST Below is a sample checklist for your consideration.

Document the administration plan for the dosing schedule Dates of loading doses

Dates of maintenance doses (if applicable)

Select the setting and the SOC for SPINRAZA administration

Outpatient Setting Inpatient Setting

Hospital outpatient off-campus clinic Inpatient hospital facility Hospital outpatient on-campus facility

Hospital-based ASC Other Setting

Freestanding ASC Other facility

Physician office

Evaluate the need for and the feasibility of an outpatient observation stay post injection

Observation stay as a possibility in lieu of inpatient admission

Determine if any ancillary services may be needed to support SPINRAZA administration via intrathecal injection

Anesthesia Fluoroscopy

Lumbar puncture Other

Ultrasound

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PATIENT CARE CHECKLIST (cont’d)Below is a sample checklist for your consideration.

Coordinate with the patient and his or her caregiver to confirm site selection and logistics and to help set appropriate expectations

Treatment process and related timelines

Current payer coverage situation and any anticipated changes

Potential financial assistance needs

SMA360° support services available for patients and their families

Suggest SMA360°™* support services, which may be available to help the patient’s family understand and navigate the treatment process

Provide the patient’s family with the SPINRAZA Start Form, assist in completing the patient portion, and review caregiver consent (see page 72 of the Appendix for a sample Start Form) • Your practice or facility should complete the HCP portion of the SPINRAZA Start Form.

Be sure to include the provider’s signature in the Prescriber Authorization section. Fax the completed Start Form to 1-888-538-9781 or email it to [email protected]

If signed consent is provided, advise the patient’s family that a FAM from Biogen will assist in coordinating the logistics of treatment, such as insurance and financial considerations, if needed

Identify which providers/provider practice groups will offer professional services related to SPINRAZA administration

Neurology Radiology Anesthesiology Other


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mailto:StartForm%40Biogen.com?subject=

INVESTIGATING BENEFITS AND OBTAINING AUTHORIZATION

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INVESTIGATING BENEFITS AND OBTAINING AUTHORIZATIONA Benefits Investigation is an important step to complete for patients prescribed SPINRAZA to determine drug and ancillary procedure medical coverage. It will help define payer requirements based on the patient’s specific insurance plan benefits and his or her individual needs.

BEGINNING THE BENEFITS INVESTIGATIONA Benefits Investigation is a process that enables a provider to determine benefit design, coverage requirements, and coding guidance. It is important to note that there are many variables associated with each patient’s benefits, and there may be differences by payer, state, general benefit design, and SOC. For SPINRAZA treatment, there may be patients who travel to an SOC that is out of state and/or out of network for his or her payer. It is important to capture this information upfront during the Benefits Investigation process so that your practice or facility can submit the claim to be reimbursed for acquiring SPINRAZA, as well as for its administration.

The following is basic patient and provider information that your practice or facility will need to gather to initiate the Benefits Investigation process.

BASIC PATIENT INFORMATION

Contact information

Patient name Date of birth Phone number

Address

Insurance information

Policyholder name

Policy start and end dates Member number

Group number

Type(s) of plan(s) (eg, HMO, PPO, POS, EPO, Medicaid) Primary, secondary, and tertiary insurance information

(eg, commercial, Medicaid)

COMPREHENSIVE SUPPORT IS AVAILABLE THROUGHOUT THE BENEFITS INVESTIGATION SMA360°* is a support service from Biogen created to help navigate the complexities of treatment logistics, insurance, and financial assistance. We understand that your patients’ needs are unique, and the SMA360° team is here to help.

We can answer any questions you may have about obtaining preauthorization or precertification, and advise you on how to best navigate the complexities of Benefits Investigation or any unforeseen bumps in the road to approval.

EPO=exclusive provider organization; HMO=health maintenance organization; POS=point of service; PPO=preferred provider organization.


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BASIC COVERAGE INFORMATION Contact the payer to gather the following information:

Coverage

Covered PA required Quantity

Patient cost

Office visit copay or coinsurance Drug cost copay or coinsurance Deductible

OOP maximum Pharmacy capitation

KEEPING ACCURATE RECORDS OF A BENEFITS INVESTIGATIONIt is important to document each communication exchange that your practice or facility has with insurance companies. You may be communicating with them several times during the Benefits Investigation. When you do, be sure to record the following:

Date of communication Contact information (direct phone line, email)

Time of communication Communication preference (fax, email)

Person(s) you spoke with Reference number for the call

BASIC PROVIDER INFORMATION

Physician prescribing SPINRAZA

Physician name NPI # Tax ID #

Physician(s) administering SPINRAZA (if different from the prescriber)

Physician name NPI # Tax ID #

Site of care administering SPINRAZA

Practice/facility name NPI # Site of care/place of service

NPI=National Provider Identifier.

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Preauthorization/ precertification

and required documentation

Payers may require an authorization of coverage prior to treatment with SPINRAZA• Determine if preauthorization/precertification is required for SPINRAZA,

administration services, and/or the SOC

• In addition, establish whether or not specific documentation is required before the plan will approve the product, administration services, and/or SOC

Medical exception/appeal

When a patient does not meet SPINRAZA coverage requirements stated in payer policy or no policy is in place, coverage may be obtained through the medical exception (ME) process and/or appeal, which tends to vary among payers• Determine if there is an ME/appeal process and what documentation is

required to demonstrate medical necessity

Referral restrictions

Depending on the patient benefits, a payer may require a referral from the primary care physician for the SOC and/or the specialists involved in the administration of SPINRAZA• If it is determined that the patient will require a referral for the administration

of SPINRAZA, find out who should provide the referral and what specifications may be needed

Observation stay rules

For patients who may require additional monitoring after SPINRAZA administration, payers may allow an outpatient observation stay of up to 48 hours• Clarify the parameters that the payer may cover for length of stay for

outpatient observation

KEY CONSIDERATIONS FOR A BENEFITS INVESTIGATION

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POTENTIAL PROVIDER NETWORK RESTRICTIONSEach payer may have a network of participating providers who have contracted to provide healthcare services under specific terms.2,3 As a result, patients may be restricted or incentivized to seek care from in-network, or preferred, providers, or else OOP costs could be higher or might not be covered at all.2,3

For Medicaid beneficiaries, coverage is generally limited to participating providers in the specific state, and individuals enrolled in Medicaid managed care may also be restricted to care from in-network providers within their state.4 However, coverage exceptions can be granted as long as medical necessity can be established, especially if there are no in-network providers with the required expertise.5

Out-of-state and/or out-of-network

restrictions

Some patients who receive SPINRAZA may face restrictions from their commercial and/or Medicaid payers because the provider and/or the service facility is out of network or out of state. In these instances, waivers or exceptions can be granted on the basis of medical necessity• Verify the state and/or network participation status for the physician(s) and/or

facility involved in the administration of SPINRAZA• Investigate and record the patient OOP cost implications for out-of-state

and/or out-of-network providers• Find out if there is an exception process for patients seeking care out of state

and/or out of network

Coordination of benefits for

multiple payers

There may be cases where your patient has multiple payers that provide benefit coverage, such as a commercial health plan and Medicaid• In the case of multiple payers, your Benefits Investigation must establish which

payer is primary, which is secondary, and if needed, which is tertiary • Once you have established the order of benefits, follow the instructions from

each payer regarding coordination of benefits for reimbursement/payment

KEY CONSIDERATIONS FOR A BENEFITS INVESTIGATION (cont’d)

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Patient financial responsibility

Patient OOP costs may vary based on the specific benefit design, SOC, and out-of-state/out-of-network restrictions• Determine the patient’s annual deductible and how much has been met

to date• Record the coinsurance and/or copay that will apply for SPINRAZA and

related services• Determine the patient’s annual OOP maximum and how much has been

met to date

Coding and claims submission details

Specific coding and billing requirements may vary by payer• Clarify the requirements for reporting an NDC number in

a medical claim• Check if any specific documentation is required to be submitted with the

claim (eg, clinical records, drug invoice)

KEY CONSIDERATIONS FOR A BENEFITS INVESTIGATION (cont’d)

Remember to reverify your patient’s benefits prior to each dose of SPINRAZA, as the insurance coverage may have changed since the patient’s last procedure. Remind your patients of the importance of immediately informing you and SMA360° of any insurance changes or updates to avoid unanticipated delays in therapy.

SMA360°* PATIENT SUPPORT SERVICES AND BENEFITS INVESTIGATIONSMA360° will also investigate the insurance benefits in order to help the patient and/or his or her family understand their current coverage and OOP costs, educate them about the financial assistance options, and offer counseling regarding the possibility of changing or adding insurance benefits, if needed. These services help supplement the Benefits Investigation conducted by your practice or facility. If you have any questions throughout this process, call SMA360° at 1-844-4SPINRAZA (1-844-477-4672), Monday through Friday, from 8:30 AM to 8:00 PM ET, or contact your Biogen representative.


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Preauthorization/ prior authorization

The payer requires that a preauthorization/PA be obtained before the treatment will be approved• Based on the payer’s requirements for authorization, demonstrate that the

treatment is medically necessary based on the patient’s diagnosis, clinical presentation, baseline motor functional testing, duration of symptoms, and current supportive care management

The initial preauthorization/

prior authorization was denied

The payer reviewed your request for a preauthorization/PA and denied it, determining that the treatment was not medically necessary• Determine if the reason for the denial was clerical, clinical, or benefit-driven

• If the denial was for clerical reasons, immediately resubmit the request with the proper information

• If the denial was for clinical reasons, determine what additional information may be required to demonstrate medical necessity

• If the denial was for benefit reasons, call the payer to determine if an exception to the benefit is allowed and the process for such an exception (eg, no out-of-network benefits but only experienced provider is out of network)

• Emphasize in your resubmission that your practice or facility believes the treatment to be medically necessary for your patient

KEY CONSIDERATIONS WHEN MEDICAL NECESSITY IS REQUIRED

The following are situations in which your practice or facility may need to demonstrate medical necessity for SPINRAZA during an appeal. The level of information in the letter will vary based on key areas that the payer requires be addressed to demonstrate medical necessity. Your practice or facility can customize the Letter of Medical Necessity based on the specific needs of the payer and the situation (see page 74 for a sample of a Letter of Medical Necessity).

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Exception based on policy

The payer has a policy for treatment and administration services for SPINRAZA, but your patient does not meet the requirements. However, the prescribing physician feels that the treatment is medically necessary• Point out that the patient requires an exception to the plan’s policy and provide

the clinical rationale demonstrating that treatment with SPINRAZA is clinically appropriate

• Provide documentation or information to demonstrate medical necessity, such as• Diagnostic evidence of SMA, including genetic testing• Clinical presentation and duration of symptoms• Current supportive care management• Expectations of therapy and how efficacy will be measured by the clinician• Other relevant aspects of patient history

Exception based on site-of-care

restrictions

The payer will not cover the treatment and administration services because it will be administered at an out-of-network or out-of-state facility• Emphasize your opinion that the facility is the most appropriate center to deliver the

highly specialized services that may be provided when administering SPINRAZA• Point out that the patient’s plan does not, in your opinion, currently have an

appropriate specialized center to treat SMA in the network and/or state, and that the patient has no other choice but to go out of his or her current network and/or state

• Point out continuity-of-care concerns of switching the patient to a new provider unfamiliar with the patient’s history

• Provide documentation or information to demonstrate medical necessity, such as• Name and specialty area of your practice or facility to demonstrate

its level of expertise• Distance the patient needs to travel to your practice or facility because there are

no other specialized facilities in his or her network and/or state • Areas of medical specialization and years of experience treating patients with SMA

KEY CONSIDERATIONS WHEN MEDICAL NECESSITY IS REQUIRED (cont’d)

When an ME/appeal is denied due to clinical reasons and the submission of an exception to benefit request has been disallowed or denied, the prescribing physician may contact the insurance carrier directly to speak with a clinical representative, who is typically a medical director or someone with a medical background. This is called a peer-to-peer discussion.• A peer-to-peer discussion can be an effective way to help the health plan understand the patient�s unique

medical history, relevant clinical factors, and how those factors support treatment with SPINRAZA• If the HCP is able to obtain the direct contact information for the clinical representative, consider tracking

that information to use for future peer-to-peer discussions

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OBTAINING APPROPRIATE AUTHORIZATIONS

When requesting a preauthorization or PA it is important to understand that each payer has different requirements with which your practice or facility must be familiar.

When obtaining details on the preauthorization or PA process, your practice or facility will need to

Determine if the information can be phoned in, faxed, emailed, or submitted through the insurer’s website

Find out how long it will take for a decision to be made

Identify the SOC for SPINRAZA administration, especially if it is in a different state than the patient lives

Keep a copy of everything that is submitted relevant to the authorization

Log any calls your office makes about the request

Follow up with the payer if your practice or facility does not receive notification of the decision in a timely manner

A PREAUTHORIZATION VS PRECERTIFICATIONA preauthorization or PA is when the insurance company requires approval of the coverage of a drug and/or treatment before the treatment is administered.6

A precertification is similar to a preauthorization/PA in that the insurance company is requiring approval of the drug and/or treatment before it is provided. You may also hear a payer refer to a precertification as a predetermination. In the case of a precertification, the insurer may require documentation that the treatment is medically necessary6; in most cases, this would be included in the form of a Letter of Medical Necessity (see page 74 for a sample of this letter).

The important thing to remember about preauthorization and precertification is that approval is required prior to treatment to indicate there is medical necessity for treatment.

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EXAMPLES OF AUTHORIZATION DOCUMENTATION AND COVERAGE PARAMETERS

REAUTHORIZATION FOR SPINRAZAFor many drugs that treat rare diseases, insurance carriers may require an authorization renewal after a certain period (typically 1 year, but it may be less). This is true regardless of whether the patient is remaining on the same treatment or transitioning to another treatment.• For patients continuing on therapy, medical plans have different intervals for reauthorization

• It is important to become familiar with the medical policy for SPINRAZA at the patient’s health plan• Be mindful of the duration of coverage at the health plan and the patient's start date

• Health plans vary widely in their requirements for reauthorization, but generally include diagnostic criteria and documentation of efficacy• A diagnosis of SMA Type 1, 2, 3, or 4, which would include genetic testing confirming the diagnosis • Efficacy of SPINRAZA is typically documented in terms of maintenance of or improvements in motor

milestones as documented in functional exam testing• Providing documentation of efficacy to health plans in a timely fashion may help enable the patient to continue

treatment uninterrupted• Clinical evaluations, such as evidence of progress in meeting motor milestones, should be conducted

continually, in line with the patient's health plan• Evidence of efficacy, such as maintenance of or improvement in motor function, can provide critical support

for reauthorization • The dosing schedule for SPINRAZA has implications for reauthorization

• Patients treated with SPINRAZA are given a loading dose on approximately days 0, 14, 28, and 58 and a maintenance dose every 4 months thereafter1

• If reauthorization is not achieved in time, the patient’s coverage may end– For plans requiring renewal every 6 months: initial approval coverage may end before maintenance dosing begins– For plans requiring renewal every 12 months: initial approval coverage may end while patient is between

maintenance doses

Identify specific documentation thatmust be submitted with the request

• Letter of Medical Necessity• Chart notes• Specific payer preauthorization/PA form• SPINRAZA Prescribing Information• Relevant literature, including previously published standards of care• Clinical documentation related to the disease, including

• Diagnostic evidence of SMA, such as genetic testing• Clinical presentation and duration of symptoms• Current supportive care management• Baseline motor function measurement• Other relevant aspects of patient history

Determine the preauthorization/PA coverage parameters

• Number of doses• Time limits of authorization• Diagnosis limitations• Submission requirements

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MOTOR MILESTONE ASSESSMENT TESTS FOR SMAThere are a variety of functional tests that can be used to assess patients with SMA. Because motor milestones in infants and children with SMA vary significantly, there is not one standardized functional assessment used in clinical practice.7,8 These tests evaluate a range of motor functions and are appropriate for different populations with SMA.8

SUMMARY OF MOTOR FUNCTIONAL TESTS FOR SMA

The Hammersmith Infant Neurological Examination

(HINE Section 2)9 Ages 2 months to 24 months

Measures neuromuscular development in infants, including voluntary grasp, sitting, ability to kick, crawling, head control, standing, rolling, and walking9

A 1-point increase in HINE score represents increased level of ability10

The Children’s Hospital of Philadelphia Infant Test of Neuromuscular Disorders

(CHOP INTEND)8 Infants and children

The first SMA-specific test to assess patients with limited motor function; can measure response to gains and losses in motor function over time8

Includes 16 items that may be graded between 0 and 4, contributing to a total score of 64 points8

The Hammersmith Functional Motor Scale—Expanded

(HFMSE)7 Ambulatory SMA Type 2 or

Type 3 patients

Assesses gross motor function of ambulatory patients7 A 2-point change is clinically relevant, eg, a child who was previously not able to crawl has increased crawling ability11

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HOW OFTEN DOES FUNCTIONAL TESTING NEED TO BE DONE?Functional testing is extremely important to include with all requests for authorizations and reauthorizations. It is recommended that testing be performed within 60 days of the intended dose, so it is important to remember not to send in authorization requests too early. Furthermore, if there is a delay that affects the date of treatment, be sure to obtain new baseline functional exam scores prior to starting therapy because the patient’s motor skills may have further declined during that period of no treatment. If changes are not documented, reauthorization may be denied because lower, undetected baseline scores could make the patient’s progress appear inadequate according to the plan’s minimum efficacy standard.

SUMMARY OF MOTOR FUNCTIONAL TESTS FOR SMA (cont’d)

The Revised Upper Limb Module (RULM)12 Age >36 months

Assesses upper limb function in ambulatory and nonambulatory patients with SMA12

Nineteen items are graded on a 3-point scale, with a score of 0 (unable), 1 (able with modification), or 2 (able, no difficulty). The maximum total score is 37, which includes a can/cannot score of 1 or 0 for the first item in the assessment12

World Health Organization (WHO) Motor Milestones13

Age 4 months to 24 months

Compares the actual windows of childhood development with those used in assessments of motor skills13 The 6 WHO motor milestones are measured and compared across similar populations in different countries13

6-Minute Walk Test (6MWT)14

Ambulatory patients

Measures the distance in meters a patient can walk unassisted14 Participants walk unaided for 25 meters, and distance walked over 6 minutes, distance covered each minute, and time to complete the 25-meter course are recorded; patients can rest without sitting and falls are recorded14

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CLAIM RECONSIDERATION AND APPEALS CHECKLIST

If a claim has been denied, you can request an appeal. There are several common reasons that claims are denied, such as an incorrect patient identification number or omission of a Letter of Medical Necessity. Another reason that a claim may be denied for SPINRAZA is that the product is not yet being covered under the insurer’s coverage benefit. In each of these cases, it is important to consider an appeal.

The following are some considerations for understanding and filing an appeal.

Review the EOB/RA to understand

the reason for the denial

Some top reasons that claims are denied: Incorrect codes Missing information Incorrect product information Lack of a Letter of Medical Necessity

If additional information is requested, submit the necessary documentation immediately.

Verify the appeals process for the payer

Consider the following to understand the appeals process of each payer: Is there a need for a particular form? How should the form be sent to the payer? Can the appeal take place over the phone via a physician-to-physician call with the payer? Who should receive the appeal (name, title, and contact information)? What must accompany the appeal (eg, supporting documentation)? How long does the appeals process usually take? How will I learn about the appeal decision?

Record the correspondence with the payer at every point of the appeals process

If your claim is denied a second time, determine if a next-level appeal is allowed and carefully submit it within your payer’s timelines. Request assistance from your Biogen representative if needed

EOB=explanation of benefits; RA=remittance advice.

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ME/APPEAL CONSIDERATIONS FOR PEDIATRIC PATIENTS WITH SMA

For continued approval of maintenance therapy with SPINRAZAWhen translating test scores into support for an ME or appeal, highlight all improvements in functional measurements compared with baseline. Because the criteria of the SMA functional tests vary, outline cumulative gain in function that the patient achieved according to earlier tests. For example, if a patient has gained the ability to hold up his/her head according to HINE Section 2, note this even if the patient most recently achieved hand grip according to CHOP INTEND. Other considerations include

Children with advanced SMA may not express improvements from baseline based on the traditional scales, but rather may show • Subtle improvements or preservation of residual distal muscles• Subtle changes that may impact activities of daily living that are relevant to the patient

Any improvement may be significant to the patient and contrary to the natural history of the disease. Therefore, it is important to document these changes for the health plan to support the medical necessity of treatment with SPINRAZA

For initial authorization for SPINRAZAInclude the following to help support medical necessity when an initial authorization request has been denied:

Test scores establishing baseline measurements, eg, HINE Section 2, CHOP INTEND, and WHO

HCP observations not tested, eg, reduction in respiratory infections or lower ventilator setting

The HCP’s opinion of the anticipated course of SMA for the patient with and without treatment

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ME/APPEAL CONSIDERATIONS FOR TEENAGERS AND ADULTS WITH SMA

It is very important to help the payer understand that the available functional tests for SMA may not be robust enough to translate functional improvement or maintenance for teenagers or adults with SMA. Payers need to understand that when a patient achieves a high score on a functional test at baseline, there may not be enough incremental difference on the scale to demonstrate the improvement that may be required by the payer.

However, there are functions that could either be achieved and/or maintained in older patients that may not be demonstrated on a scale at all, but are extremely important and medically necessary to the patient. For example:

Activities of daily living (ADL), including eating, cooking, feeding oneself, and personal hygiene

Mobility-related ADLs, such as working, paying bills, grocery shopping, cleaning, and laundry

School

Employment

Sample Letters of Medical Necessity can be reviewed on page 74 of this guide and are available from your Biogen representative.

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IF AN INTERNAL APPEAL IS DENIED, CONSIDER AN EXTERNAL REVIEWAppeals should follow the individual payer’s requirement(s) and include additional information that continues to emphasize the medical necessity of SPINRAZA for your patient. At the end of the internal appeals process, the health plan must provide you and your patient with a written decision, but this does not mean that the appeals process is over. There may be other courses of action, such as an independent external review.

• In an external review process, an independent, accredited medical professional will review your patient's case. The reviewer does not receive any financial incentives to perform the review. The insurance carrier is required by law to accept the reviewer's decision15

• To request an external review, most plans require that the patient file a written request within 60 days following the insurance carrier�s final determination. The letter sent to you and your patient should describe how to request an external review15

• External review decisions are made as soon as possible, and should take no longer than 60 days from receipt of request

EXPEDITED REVIEWSExpedited reviews can be requested in the case of an urgent situation where a delay in treatment would risk the life of the patient.

• Reviews can be expedited by requesting that an external review be done simultaneously with the internal review. An expedited appeal may be granted if your patient is currently receiving or waiting to start a prescribed treatment and you believe a delay would be life threatening, affect the patient�s ability to regain maximum function, or subject him or her to severe pain. The request for an expedited appeal may be made verbally. The health plan must make a decision within 4 business days after your patient�s request is received16

BEN

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YOUR BIOGEN REPRESENTATIVE IS HERE TO HELP


† The link above will take you to a website that is outside the control of Biogen. Links are provided as a courtesy for informational purposes only. We do not make or imply any endorsement of external websites.†

If you have any questions throughout this process, call SMA360°* at 1-844-4SPINRAZA (1-844-477-4672) or contact your Biogen representative.

For more information about an external claim review, go to healthcare.gov/appeal-insurance-company-decision/external-review/ or talk to your Biogen RDRM for assistance.†

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https://www.healthcare.gov/appeal-insurance-company-decision/external-review/

https://www.healthcare.gov/appeal-insurance-company-decision/external-review/

NAVIGATING FINANCIAL ASSISTANCE OPTIONS

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Patient cost-sharing

considerations

Copay: Typically, a flat fee that patients pay each time they receive medical care. The copay may be in addition to other OOP costs, such as deductibles and coinsurance, and it varies by benefit structure

Coinsurance: A beneficiary cost-sharing amount that begins after the deductible is paid. Coinsurance typically is based on a percentage of the cost of services and varies by payer

Deductible: A predetermined amount of money that the patient must spend before his or her payer benefits take effect

Maximum OOP cost: An annual limitation on all cost sharing that patients are responsible for under a health insurance plan. This limit does not apply to premiums, balance-billed charges from out-of-network HCPs, or services that are not covered by the plan

In addition to the Benefits Investigation conducted by your practice or facility, SMA360° will investigate patient benefits in order to be able to inform the patient’s family about potential cost-sharing responsibility and to discuss potential implications.

NAVIGATING FINANCIAL ASSISTANCE OPTIONSThe SMA360°* team can help your patients’ families navigate the cost of treatment with SPINRAZA. Patients may have a copay or coinsurance for the drug and/or for the administration of SPINRAZA after they meet their annual deductible and until they reach the annual limit for their maximum OOP costs.

Biogen believes that cost should not be a barrier to treatment. SMA360° offers personalized insurance and financial assistance to help your patients’ families understand their insurance benefits for SPINRAZA and to identify the most affordable way to start and stay on treatment as prescribed by their doctor.

PATIENT COST-SHARING STRUCTURE CONSIDERATIONS

During the Benefits Investigation, it is important to determine key elements of the cost-sharing structure under the patient’s insurance benefits, including the following:


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$0 Drug Copay Program From Biogen: Generally, all individuals on nongovernment insurance are eligible, regardless of income, and there is no annual maximum on the amount Biogen will cover as part of the program. Insurance will be billed first and must pay before copay assistance will be applicable

Individuals receiving coverage from Medicare, Medicaid, the VA/DoD, TRICARE®,† or any other governmental or pharmaceutical assistance may not be eligible

$0 Procedure Copay Program From Biogen: In addition to the above criteria, individuals are eligible for this program if they meet the following requirements: • They are not a resident of Massachusetts, Michigan, Minnesota, or Rhode Island• The HCP submits a request for treatment using an approved procedure code for

anesthesia, imaging procedures, and/or surgical procedure/drug administration • The following procedure codes approved by Biogen are eligible for the program

• Anesthesia17,18

– Lumbar region—00635– Extreme age—99100– Revenue Code—370

• Imaging Procedure/Guidance17

– Fluoroscopy—77003– Ultrasound—76942– CT guidance—77012

• Surgical Procedure and Drug Administration17

– Intrathecal drug administration—96450– Lumbar puncture, diagnostic—62270– Lumbar puncture, therapeutic—62272– Injection(s), without imaging guidance—62320– Injection(s), with imaging guidance—62321– Injection(s), without imaging guidance—62322– Injection(s), with imaging guidance—62323

Third-Party Funding Assistance: If it is determined that a family is not eligible for the $0 Copay Program, an SMA Lead Case Manager can help find a charitable organization that may provide third-party assistance

SMA360°* FINANCIAL ASSISTANCE AND INSURANCE COUNSELING SERVICESBiogen provides several comprehensive financial support services to help reduce nonclinical barriers to patient access.

Patients are required to enroll separately in each Biogen financial assistance program. Your Biogen representative is available to provide you with additional information about financial resources for your patients.

See page 73 for a sample of the SPINRAZA Copay Reimbursement Form, which is used for both Biogen copay programs. A copy of the form is available from your Biogen representative.

CT=computed tomography; DoD=Department of Defense; United States Department of Veterans Affairs.* SMA360° services from Biogen are available only to those who have been prescribed SPINRAZA. SMA360° is intended for US residents only.†TRICARE is a registered trademark of the Department of Defense (DoD), DHA. All rights reserved.

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INITIATING THE $0 DRUG COPAY PROGRAM FROM BIOGENThis program generally is available for patients with nongovernmental insurance benefits who have provided consent to Biogen. It covers the amount of cost sharing for SPINRAZA, but does not cover administration-related costs. After conducting a Benefits Investigation, the SMA360° team will contact eligible patients to introduce the program and to complete enrollment.

What your practice or facility needs to do

1

Confirm patient enrollment

Confirm that the patient is enrolled in the $0 Drug Copay Program for SPINRAZA for every treatment dose. At enrollment, the patient and HCP will receive a confirmation letter via fax from Biogen. This information also is available through your Biogen representative

• Keep the confirmation of enrollment in the patient’s file. If the patient withdraws, Biogen will send a withdrawal letter. This information also is available by calling 1-844-4SPINRAZA (1-844-477-4672)

An EOB is a statement sent by a health plan to a member to describe what medical treatments and/or services were paid on his or her behalf. The EOB may also be called remittance advice and usually is used with Medicare and Medicaid payments. Ask your patient for his or her EOB/RA regarding SPINRAZA treatment.

2

Obtain EOB/RA

Locate the EOB/RA demonstrating the patient’s financial responsibility for SPINRAZA

3

Fill out the Copay Reimbursement

Form

Fill out the Copay Reimbursement Form

4

Submit for reimbursement

• Fax the EOB/RA and the completed Copay Reimbursement Form to Biogen at 1-888-656-4343

• Your practice or facility will receive a reimbursement check for plans that cover SPINRAZA under the medical benefit. For plans that cover SPINRAZA under the pharmacy benefit, Accredo SP manages the adjudication via the Rx BIN, PCN, and Group Number

If you have any questions throughout this process, call SMA360° at 1-844-4SPINRAZA (1-844-477-4672) or contact your Biogen representative.SMA360° offers insurance counseling services to help patients’ families understand their current insurance benefits for SPINRAZA and to provide assistance with changing or adding supplemental insurance benefits, such as Medicaid.

BIN=bank identification number; PCN=processor control number.

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INITIATING THE $0 PROCEDURE COPAY PROGRAM FROM BIOGEN

This program generally is available for patients with nongovernmental insurance benefits who have provided consent to Biogen. It covers the amount of cost sharing for the administration procedure that is associated with SPINRAZA, but it does not cover the cost of the drug. After conducting a Benefits Investigation, the SMA360°™* team will contact eligible patients to introduce the program and to complete enrollment.

What your practice or facility needs to do

The eligibility criteria differ for the $0 Drug Copay Program and the $0 Procedure Copay Program. For more information, consult with your Biogen representative.

1

Confirm patient enrollment

Confirm that the patient is enrolled in the $0 Procedure Copay Program for SPINRAZA for every treatment dose. At enrollment, the patient and HCP will receive a confirmation letter via fax from Biogen. This information also is available through your Biogen representative

• Keep the confirmation of enrollment in the patient’s file. If the patient withdraws, Biogen will send a withdrawal letter. This information also is available by calling 1-844-4SPINRAZA (1-844-477-4672)

2

Obtain EOB

Locate the provider/facility RA and/or the patient’s EOB demonstrating the patient’s financial responsibility for SPINRAZA

3

Fill out the Copay Reimbursement

Form

Fill out the Copay Reimbursement Form

4

Submit for reimbursement

Fax the EOB/RA and the completed Copay Reimbursement Form to Biogen at 1-888-656-4343


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ORDERING SPINRAZA® (nusinersen)

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ORDERING SPINRAZAThe SMA360°™* team will contact the enrolled patient’s family to coordinate treatment logistics for each SPINRAZA administration visit. It is important for your office to coordinate with your Biogen representative when ordering SPINRAZA so that the patient’s family can be prepared for the visit.

HOW TO ORDER SPINRAZACuraScript SD and Accredo SP are the exclusive authorized providers of SPINRAZA. Ordering SPINRAZA is done in the same way as any other product that is administered at your SOC, whether it is an outpatient hospital-based facility,* physician office, freestanding ASC, or inpatient hospital facility. SPINRAZA can be ordered directly through CuraScript SD or from Accredo SP. Once the order for SPINRAZA has been submitted to your pharmacy or procurement department, the order for SPINRAZA will be placed.

SPINRAZA ORDERING CHECKLIST

Confirm that your practice or facility is ready to order SPINRAZA

Benefits Investigation has been conducted

Payer approval of appropriate authorizations has been obtained

(Optional) Patient has been enrolled in available financial assistance program(s)

Order SPINRAZA from CuraScript SD or Accredo SP

Follow the standard process for placing a prescription drug order in your practice or facility

• The SPINRAZA Start Form includes a prescription for SPINRAZA. However, some states may require a separate prescription to be sent to Accredo SP

Your pharmacy or procurement department will need to submit the order form to CuraScript SD

• 1-855-778-1510 (phone)• 1-866-579-4655 (fax)

Coordinate SPINRAZA shipment delivery with the scheduled patient treatment visit

CuraScript SD or Accredo SP will ship SPINRAZA in a temperature-controlled container directly to your practice or facility

Make sure there is a staff member available to accept delivery of SPINRAZA and to transfer the product to a refrigerated space in the pharmacy immediately upon receipt of the drug

Coordinate the treatment procedure for SPINRAZA with your site’s care team, including the pharmacy

For assistance with any step in this process, contact your Biogen representative.

* SMA360° services from Biogen are available only to those who have been prescribed SPINRAZA. SMA360° is intended for US residents only.†Including off-campus clinic, on-campus facility, hospital-based ASC, and other outpatient outlets operated by a hospital.

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SUBMITTING CLAIMS FOR SPINRAZA® (nusinersen)AND RELATED SERVICES

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Hospital facilities and hospital-based ASCs may submit a CMS-1450/UB-04 claim form18

Physician office practices may submit a CMS-1500 claim form either for professional services related to drug administration or for the drug and the services related to drug administration19

Freestanding ASCs may submit a CMS-1500 claim form for the medication and the services related to drug administration19

FOLLOWING PAYER BILLING GUIDELINES CAN FACILITATE CLAIM PROCESSING AND PROMPT PAYMENTWhen a patient has been administered the SPINRAZA injection and/or a related service, your practice or facility may submit a claim to the patient’s insurance plan. Items included on your claim may depend on the SOC and the billing entity.

The information within this section reviews some of the billing codes relevant for SPINRAZA and the related administration services, as well as key billing considerations across SOCs. However, coding and billing recommendations may vary by payer. Your practice or facility should check directly with the patient’s payer(s) to verify specific coding and billing requirements. Biogen field representatives are available to answer questions and further support the reimbursement process.

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SUMMARY OF RELEVANT CODES FOR SPINRAZA

ICD-10-CM CODE EXAMPLES

ICD-10-CM Code20 Description20

G12.0 Infantile spinal muscular atrophy, type I [Werdnig-Hoffmann]

G12.1

Other inherited spinal muscular atrophy Adult form spinal muscular atrophyChildhood form, type II spinal muscular atrophyJuvenile form, type III spinal muscular atrophy [Kugelberg-Welander]

HCPCS CODE

HCPCS Code21 Description21

J2326 Injection, nusinersen, 0.1 mg

• Since SPINRAZA has been assigned a permanent J-code, effective January 1, 2018, C9489 should no longer be used.

HCPCS=Healthcare Common Procedure Coding System; ICD-10-CM=International Classification of Diseases, Tenth Revision, Clinical Modification.

NDC NUMBER

NDC Number1

Description1

10-digit format 11-digit format

64406-058-01 64406-0058-0112 mg/5 mL single-dose vial (contains 12 mg of nusinersen solution for intrathecal injection)

Although the FDA uses a 10-digit format when registering NDC numbers, payers often require an 11-digit NDC format on claim forms for billing purposes.22 It is important to confirm with your payer which NDC format is required. In addition, Medicaid requires that all claims for provider-administered drugs include NDC numbers.

This reporting requirement might also be implemented by some commercial payers.23 Guidelines for reporting the NDC number in the appropriate format, quantity, and unit of measure24 vary by state and by payer and should be reviewed prior to submitting a claim.

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CPT® CODE EXAMPLES

Procedure Type17 CPT® Code17

Description17

Drug Administration & Surgical Procedure

96450Chemotherapy administration, into central nervous system (CNS) (eg, intrathecal), requiring and including spinal puncture

62272 Spinal puncture, therapeutic, for drainage of cerebrospinal fluid (by needle or catheter)

62320

Injection(s), of diagnostic or therapeutic substance(s) (eg, anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, interlaminar epidural or subarachnoid, cervical or thoracic; without imaging guidance

62321Injection(s) of diagnostic or therapeutic substance(s) as described in code 62320; with imaging guidance

62322

Injection(s), of diagnostic or therapeutic substance(s) (eg, anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, interlaminar epidural or subarachnoid, lumbar or sacral (caudal); without imaging guidance

62323Injection(s) of diagnostic or therapeutic substance(s) as described in code 62322; with imaging guidance

Imaging Procedure/ Guidance

77003

Fluoroscopic guidance and localization of needle or catheter tip for spine or paraspinous diagnostic or therapeutic injection procedures (eg, epidural or subarachnoid)

76942Ultrasonic guidance for needle placement (eg, biopsy, aspiration, injection, localization device), imaging supervision and interpretation

77012Computed tomography guidance for needle placement (eg, biopsy, aspiration, injection, localization device), radiological supervision and interpretation

CPT=Current Procedural Terminology®.

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CONSIDERATIONS FOR ADMINISTRATIONSPINRAZA is administered intrathecally by, or under the direction of, an HCP with experience performing lumbar punctures. In addition, providers can consider the following services for the administration of SPINRAZA, as needed1:• Sedation as indicated by the clinical condition of the patient• Ultrasound or other imaging techniques to guide intrathecal administration of SPINRAZA

Moderate sedation (MS) is a drug-induced semiconscious state that allows patients to be comfortable during certain surgical or medical procedures. MS requires no interventions to maintain cardiovascular function or a patent airway, and spontaneous ventilation is adequate.17

Coding for MS is based on total intraservice time and the HCP who performs the procedure.17

CPT® CODE EXAMPLES (cont’d)

Procedure Type17

CPT® Code17 Description17

Anesthesia00635

Anesthesia for procedures in lumbar region (eg, diagnostic or therapeutic lumbar puncture)

99100Anesthesia for patient of extreme age, younger than 1 year and older than 70 (list separately in addition to code for primary anesthesia procedure)

Moderate (Conscious) Sedation

99151-99153, 99155-99157

Drug-induced depression of consciousness, during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. Coding is based on total intraservice time and the healthcare professional who is performing the procedure. For descriptions of individual codes, refer to the American Medical Association’s CPT® 2019 Professional

Treatment Observation

99218 -99220

Initial observation care, per day, for the evaluation and management of a patient, which requires these 3 key components: a detailed or comprehensive history, a detailed or comprehensive examination, and varying levels of medical decision-making complexity

99217Observation care discharge is to be utilized to report all services provided to a patient on outpatient hospital observation status if the discharge is on other than the initial date of observation status

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CODING GUIDE FOR MODERATE SEDATION OF LESS THAN 52 MINUTES17

Total intra-service time for MS*

Patient age Code(s) Code(s)

Less than 10 minutes Any age Not reported

separatelyNot reported

separately

10-22 minutes <5 years 99151 99155

10-22 minutes 5 years or older 99152 99156

23-37 minutes <5 years 99151 + 99153 x 1 99155 + 99157 x 1

23-37 minutes 5 years or older 99152 + 99153 x 1 99156 + 99157 x 1

38-52 minutes <5 years 99151 + 99153 x 2 99155 + 99157 x 2

38-52 minutes 5 years or older 99152 + 99153 x 2 99156 + 99157 x 2

* For MS coding of 53 minutes or longer, or for descriptions of individual codes, please refer to page 737 of the CPT coding book CPT® 2019 Professional.

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UNIQUE BILLING CONSIDERATIONS FOR OUTPATIENT HOSPITAL-BASED FACILITIESCPT® CODE MODIFIER EXAMPLES

Modifier17,25 Description17,25

22 Increased procedural services23 Unusual anesthesia services

25 Significant, separately identifiable evaluation and management service by the same physician or other qualified HCP on the same day of procedure or other service

51 Multiple procedures

52 Reduced services

53 Discontinued procedure

59 Distinct procedural service

JG Drug or biological acquired with 340B drug pricing program discount

TB Drug or biological acquired with 340B drug pricing program discount, reported for informational purposes

Appropriate modifier(s) can help report additional circumstances under which a specific procedure and/or ancillary services were provided.

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CPT® CODE EXAMPLES FOR OUTPATIENT OBSERVATION

Procedure Type17

CPT® Code17 Description17

Outpatient Hospital Observation Status

99218 -99220

Initial observation care, per day, for the evaluation and management of a patient, which requires these 3 key components: a detailed or comprehensive history; a detailed or comprehensive examination; and varying levels of medical decision-making

99217Observation care discharge is to be utilized to report all services provided to a patient on outpatient hospital observation status if the discharge is on other than the initial date of observation status

99234 -99236

Observation or inpatient hospital care is used for the evaluation and management of a patient who is admitted and discharged on the same date, which requires these 3 key components: a detailed or comprehensive history; a detailed or comprehensive examination; and varying levels of medical decision-making complexity

Following administration, an additional observational period may be required after treatment administration for patients who have complications or need extended observation (beyond typical recovery time) to determine if a patient can be discharged or if he or she will need inpatient admission. Use the CPT® codes listed above for observational stay.

REVENUE CODE EXAMPLES FOR OUTPATIENT HOSPITAL-BASED FACILITIES*

Service Type18 Revenue Code18 Description18

Drug Product 0636 Pharmacy (ie, drugs requiring detailed coding)

Drug Administration, Surgical Procedure, Recovery, and Observation

0331 Radiology/therapeutic (ie, chemotherapy injected)0361 Operating room services (ie, minor surgery)0499 Ambulatory surgical care (ie, other ambulatory surgical care)

0710 Recovery room permits identification of particular services, if necessary

0760 Treatment/observation room (ie, general classification)0762 Treatment/observation room (ie, observation room)

Anesthesia Services 0370 Anesthesia (ie, general classification)

Imaging Services0402 Other imaging services (ie, ultrasound)0409 Other imaging services (ie, other imaging services)

Revenue codes are required for hospital outpatient billing and will vary depending on the revenue center to which your hospital maps SPINRAZA. Typically, SPINRAZA will be reported using the revenue codes listed above.* Including off-campus clinic, on-campus facility, hospital-based ASC, and other outpatient outlets operated by a hospital.

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CODING SUMMARY FOR ELECTRONIC CLAIM SUBMISSION BY OUTPATIENT HOSPITAL-BASED FACILITIES*The table below provides examples of relevant codes, along with corresponding locations, for paper and electronic claims submitted by outpatient hospital-based facilities for SPINRAZA and related administration services.

Requirements and location of information will vary by payer.

Examples of Relevant Codes for SPINRAZA and Electronic Billing Locations for Outpatient Hospital-Based Facilities26

Information Sample Code(s) or Information

CMS-1450/ UB-04 Locator26

Electronic Loop26

Equivalent Segment26

HCPCS Level II Code J2326 Field 44 2400 SV202-2

HCPCS Level II Code Units 120 Field 46 2400 SV205

Additional Product Information

SPINRAZA 64406-0058-01

12 mg/5 mL, 5 mL intrathecal inj

Field 80 2300 NTE

CPT® Code(s) 96450

Other CPT® codes may apply, as appropriate

Field 44 2400 SV202-2

ICD-10-CM Code (primary) G12.0 Field 67 2300 HI01-2

Bill Type Code Provider specific† Field 4 2300 CLM05-1

Revenue Code(s)

03610636

Other revenue codes may apply, as appropriate

Field 42 2400 SV201

* Including off-campus clinic, on-campus facility, hospital-based ASC, and other outpatient outlets operated by a hospital.† A 4-digit bill type code documents facility type (second digit after the leading zero), care type (third digit), and the bill sequence for the given episode of care (fourth digit). Relevant examples for outpatient facilities include 013X (hospital outpatient), 074X (clinic outpatient physical therapy [OPT]), and 083X (hospital outpatient ASC), where X represents the sequence of the billing in this particular episode of care (eg, “1” for admit through discharge claim).18

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APPROVED OMB NO.

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1 2 4 TYPE OF BILL

FROM THROUGH 5 FED. TAX NO.

a

b

c

d

DX

ECI

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

a b c

a

b c d

ADMISSION CONDITION CODES DATE 12

OCCURRENCE OCCURRENCE33 OCCURRENCE OCCURRENCE SPAN 35 OCCURRENCE SPAN CODE DATE CODE CODE CODE DATE CODEDATE DATE THROUGH

VALUE CODES 39 VALUE CODES VALUE CODES CODE AMOUNT CODE AMOUNT CODE AMOUNT

TOTALS

41

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

FIRST

c. d.OTHER PROCEDURE

75

e. OTHER PROCEDURE NPICODE DATE DATE

FIRST

NPI

b LAST FIRST

c NPI

d LAST FIRST

UB-04 CMS-1450

7

10 BIRTHDATE 11 SEX 16 DHR 18 19 20 21 22 23

CODE

13 HR 14 TYPE 15 SRC

FROM

25 26 2827

CODE FROM

OTHER

PRV ID

b

. INFO BEN.

29 ACDT 30

31

52 REL

THROUGH 32 34 36 37

38 40

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

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 76 ATTENDING

80 REMARKS

OTHER PROCEDURE

a

77 OPERATING

78 OTHER

79 OTHER

81CC

PAGE OF CREATION DATE

3a PAT. CNTL #

24

b. MED. REC. #

44 HCPCS / RATE / HIPPS CODE

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

OCCURRENCE

QUAL

QUAL

QUAL

CODE DATE

1

2

3

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C

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

National Uniform NUBC™

Billing Committee

LIC9213257

G12.0

SAMPLE

SPINRAZA 64406-0058-0112 mg/5 mL, 5 mL intrathecal inj

0636 SPINRAZA 64406005801 J2326 1200361 Minor Surgery 96450 1

013X

SAMPLE CMS-1450/UB-04 CLAIM FORM FOR OUTPATIENT HOSPITAL-BASED FACILITIES*

Field 67: Enter the appropriate primary ICD-10-CM diagnosis code; for example:• G12.0, Infantile spinal

muscular atrophy, type I [Werdnig-Hoffmann]

Field 4: Enter the appropriate type of bill code; for example†:• 013X, Hospital outpatient• 074X, Clinic OPT• 083X, Hospital outpatient

(ASC)† X represents a placeholder for the fourth digit, which indicates the sequence of this bill in this particular episode of care (eg, “1” for admit through discharge claim).

Field 46: Enter the appropriate number of units of service.

Fields 42 and 43: Enter appropriate revenue codes and corresponding description of service; for example:• 0636, Pharmacy (ie, drugs requiring detailed coding)||

• 0361, Operating room services (ie, minor surgery)NOTE: Other revenue codes may apply; for example:• 0331, Radiology/therapeutic (ie, chemotherapy injected)• 0370, Anesthesia (ie, general classification)• 0402, Other imaging services (ie, ultrasound)• 0710, Recovery room||For Field 43, NDC reporting requirements may vary by payer.

Field 44: Enter appropriate CPT®/HCPCS codes and modifiers; for example:• J2326, Injection, nusinersen, 0.1mg• 96450, Chemotherapy administration, into CNS

(eg, intrathecal), requiring spinal punctureNOTE: Other CPT® codes may apply; for example:• 62272, Spinal puncture, therapeutic, for drainage of

cerebrospinal fluid (by needle or catheter)• 76942, Ultrasonic guidance for needle placement (eg,

biopsy, aspiration, injection, localization device), imaging supervision, and interpretation

• 77012, Computed tomography guidance for needle placement (eg, biopsy, aspiration, injection, localization device), radiological supervision and interpretation

*Including off-campus clinic, on-campus facility, hospital-based ASC, and other outpatient outlets operated by a hospital.

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UNIQUE BILLING CONSIDERATIONS FOR PROFESSIONAL SERVICES

CPT® CODE MODIFIER FOR THE PROFESSIONAL COMPONENT

Modifier17 Description17

26 Professional component

For procedure codes with professional and technical components, physician office practices may use the 26 modifier to bill for the professional services component of the procedure performed in the hospital inpatient or outpatient setting.17

CODING SUMMARY FOR ELECTRONIC CLAIM SUBMISSION FOR PROFESSIONAL SERVICESThe table below provides examples of relevant codes, along with corresponding locations, for paper and electronic claims submitted by physician office practices for professional services associated with SPINRAZA administration.


Examples of Relevant Codes for SPINRAZA and Electronic Billing Locations for Professional Services27


CMS-1500 Location27

Electronic Loop27


CPT® Code(s)

964507694200635


Field 24D 2400 SV101

ICD-10-CM Code (primary) G12.0 Field 21A 2300 HI01-2

Place of Service Code Provider-specific* Field 24B 2300 CLM05-1

* A 2-digit place of service code documents site of care. Relevant examples for professional services include 19 (off-campus outpatient hospital), 22 (on-campus outpatient hospital), and 21 (inpatient hospital).28

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SAMPLE CMS-1500 CLAIM FORM FOR PROFESSIONAL SERVICES

SAMPLE

APPROVED OMB-0938-1197 FORM 1500 (02-12) PLEASE PRINT OR TYPE

G12.0

9645022

22

22 00635

76942 26

Field 24D: Enter appropriate CPT®/HCPCS codes and modifiers; for example:• 62272, Spinal puncture, therapeutic, for drainage

of cerebrospinal fluid (by needle or catheter)• 96450, Chemotherapy administration, into CNS

(eg, intrathecal), requiring spinal puncture• 76942, Ultrasonic guidance for needle placement

(eg, biopsy, aspiration, injection, localization device), imaging supervision, and interpretation• 26, Professional component

• 00635, Anesthesia for procedures in lumbar region; diagnostic or therapeutic lumbar puncture

NOTE: Other CPT® codes and modifiers may apply.

Field 24B: Enter the appropriate place of service code; for example:• 19, Off-campus outpatient hospital• 22, On-campus outpatient hospital• 21, Inpatient hospital

Field 21A: Enter the appropriate primary ICD-10-CM diagnosis code; for example:• G12.0, Infantile spinal muscular

atrophy, type I [Werdnig-Hoffmann]

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UNIQUE BILLING CONSIDERATIONS FOR PHYSICIAN OFFICES AND FREESTANDING ASCs

CODING SUMMARY FOR ELECTRONIC CLAIM SUBMISSION BY PHYSICIAN OFFICES AND FREESTANDING ASCs The table below provides examples of relevant codes, along with corresponding locations, for paper and electronic claims submitted by physician office practices or freestanding ASCs for SPINRAZA and related administration services.


Examples of Relevant Codes for SPINRAZA and Electronic Billing Locations for Physician Offices and Freestanding ASCs27


CMS-1500 Location27

Electronic Loop27


HCPCS Level II Code J2326 Field 24D 2400 SV101

HCPCS Level II Code Units 120 Field 24G 2400 SV101


SPINRAZA 64406-0058-01 12 mg/5 mL, 5 mL

intrathecal injField 19 2300 NTE

CPT® Code(s) 96450


Field 24D 2400 SV101

ICD-10-CM Code (primary) G12.0 Field 21A 2300 HI01-2

Place of Service Code Provider-specific* Field 24B 2300 CLM05-1

*A 2-digit place of service code documents site of care. Relevant examples for professional services include 11 (office) and 24 (ASC).28

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SAMPLE

APPROVED OMB-0938-1197 FORM 1500 (02-12) PLEASE PRINT OR TYPE

G12.0

SPINRAZA 64406-0058-01 12 mg/5 mL, 5mL intrathecal inj

J2326

96450

120

1

24

24

SAMPLE CMS-1500 CLAIM FORM FOR PHYSICIAN OFFICES AND FREESTANDING ASCs

Field 21A: Enter the appropriate primary ICD-10-CM diagnosis code; for example:• G12.0, Infantile spinal muscular

atrophy, type I [Werdnig-Hoffmann]

Field 24G: Enter the appropriate number of units of service.

Field 24D: Enter appropriate CPT®/HCPCS codes and modifiers; for example:• J2326, Injection, nusinersen, 0.1mg• 96450, Chemotherapy administration, into CNS (eg, intrathecal), requiring spinal punctureNOTE: Other CPT® codes and modifiers may apply, for example:• 00635, Anesthesia for procedures in lumbar region; diagnostic or therapeutic lumbar puncture• 76942, Ultrasonic guidance for needle placement (eg, biopsy, aspiration, injection, localization

device), imaging supervision, and interpretation

Field 19: Enter additional product information as required by the patient’s payer, such as the drug name, 11-digit NDC number, concentration, amount, and route of administration; for example:• SPINRAZA 64406-0058-01 12 mg/5 mL, 5 mL intrathecal injNOTE: Requirements may vary by payer.

Red shaded areas for fields 24A-D: NDC reporting requirements may vary by payer

Field 24B: Enter the appropriate place of service code; for example:• 11, Office• 24, ASC

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UNIQUE BILLING CONSIDERATIONS FOR INPATIENT HOSPITAL FACILITIESREVENUE CODE EXAMPLES FOR INPATIENT HOSPITAL FACILITIES

Service Type18 Revenue Code18 Description18

Drug Product 0636 Pharmacy (ie, drugs requiring detailed coding)

Room and Board 0101 All-inclusive rate (ie, all-inclusive room and board)

Drug Administration, Surgical Procedure, Recovery, and Observation

0272 Medical/surgical supplies (ie, sterile supply)

0331 Radiology/therapeutic

0360 Operating room services (ie, general classification)

0369 Operating room services (ie, other operating room services)

0710 Recovery room permits identification of particular services, if necessary

Anesthesia Services 0370 Anesthesia (ie, general classification)

Imaging Services0402 Other imaging services (ie, ultrasound)

0409 Other imaging services (ie, other imaging services)

Revenue codes are required for hospital inpatient billing and will vary depending on the revenue center to which your hospital maps SPINRAZA. Typically, SPINRAZA will be reported using the revenue codes listed above.

ICD-10-PCS PROCEDURE CODE EXAMPLES

Procedure Type29 ICD-10-PCS Code29 Description29

Intrathecal Drug Administration 3E0R3GC Introduction of other therapeutic substance into spinal

canal, percutaneous approach

Imaging Procedure/ Guidance

BR13YZZ Fluoroscopy of lumbar disc(s) using other contrast

BR49ZZZ Ultrasonography of lumbar spine

Inhalation Anesthesia 3E0F7BZ Introduction of anesthetic agent into respiratory tract,

via natural or artificial opening

When SPINRAZA is administered in the inpatient setting, appropriate inpatient procedure codes will need to be reported on the claim. Typically, SPINRAZA administration procedures will be reported using the ICD-10-PCS codes listed above.ICD-10-PCS=International Classification of Diseases, Tenth Revision, Procedure Classification System.

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CODING SUMMARY FOR ELECTRONIC CLAIM SUBMISSION BY INPATIENT HOSPITAL FACILITIESThe table below provides examples of relevant codes, along with corresponding locations, for paper and electronic claims submitted by inpatient hospital facilities for SPINRAZA and related administration services (as part of a planned inpatient stay).


Examples of Relevant Codes for SPINRAZA and Electronic Billing Locations for Inpatient Hospital Facilities26


CMS-1450/ UB-04 Locator26

Electronic Loop26


HCPCS Level II Code J2326 Field 44 2400 SV202-2

HCPCS Level II Code Units 120 Field 46 2400 SV205


SPINRAZA 64406-0058-01 12 mg/5 mL, 5 mL

intrathecal injField 80 2300 NTE

ICD-10-PCS Code(s)

3E0R3GCBR13YZZ3E0F7DZ

Other ICD-10-PCS codes may apply, as appropriate

Fields 74-74E 2300HI01-2

through HI05-4

ICD-10-CM Code (primary) G12.0 Field 67 2300 HI01-2

Bill Type Code Provider-specific* Field 4 2300 CLM05-1

Revenue Code(s)

0101, 0272, 0360, 0370, 0409, 0636

Other revenue codes may apply, as appropriate

Field 42 2400 SV201

* A 4-digit bill type code documents facility type (second digit after the leading zero), care type (third digit), and the bill sequence for the given episode of care (fourth digit). Relevant examples for inpatient hospital facilities include 011X (hospital inpatient) and 014X (hospital other), where X represents the sequence of the bill in this particular episode of care (eg, “1” for admit through discharge claim).18

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__ __ __

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APPROVED OMB NO.

__1 2 4 TYPE

OF BILL

FROM THROUGH 5 FED. TAX NO.

a

b

c

d

DX

ECI

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

a b c

a

b c d

ADMISSION CONDITION CODES DATE 12

OCCURRENCE OCCURRENCE33 OCCURRENCE OCCURRENCE SPAN 35 OCCURRENCE SPAN CODE DATE CODE CODE CODE DATE CODEDATE DATE THROUGH

VALUE CODES 39 VALUE CODES VALUE CODES CODE AMOUNT CODE AMOUNT CODE AMOUNT

TOTALS

41

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

FIRST

c. d.OTHER PROCEDURE

75

e. OTHER PROCEDURE NPICODE DATE DATE

FIRST

NPI

b LAST FIRST

c NPI

d LAST FIRST

UB-04 CMS-1450

7

10 BIRTHDATE 11 SEX 16 DHR 18 19 20 21 22 23

CODE

13 HR 14 TYPE 15 SRC

FROM

25 26 2827

CODE FROM

OTHER

PRV ID

b

. INFO BEN.

29 ACDT 30

31

52 REL

THROUGH 32 34 36 37

38 40

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

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 76 ATTENDING

80 REMARKS

OTHER PROCEDURE

a

77 OPERATING

78 OTHER

79 OTHER

81CC

PAGE OF CREATION DATE

3a PAT. CNTL #

24

b. MED. REC. #

44 HCPCS / RATE / HIPPS CODE

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

OCCURRENCE

QUAL

QUAL

QUAL

CODE DATE

1

2

3

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C

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

National Uniform NUBC™

Billing Committee

LIC9213257

SAMPLE

G12.0

SPINRAZA 64406-0058-0112 mg/5 mL, 5 mL intrathecal inj

0101 All-Inclusive Room and Board 0272 Sterile Supply 0360 Operating Room Services/General 0370 Anesthesia/General 0409 Other Imaging Services 0636 SPINRAZA 64406005801 J2326

3E0R3GC BR13YZZ 3E0F7DZ

0111

SAMPLE CMS-1450/UB-04 CLAIM FORM FOR INPATIENT HOSPITAL FACILITIES

Field 67: Enter the appropriate primary ICD-10-CM diagnosis code; for example:• G12.0, Infantile spinal

muscular atrophy, type I [Werdnig-Hoffmann]

Fields 42 and 43: Enter appropriate revenue code and description of service; for example:• 0101, All-inclusive rate (ie, all-inclusive room and board)• 0272, Medical/surgical supplies (ie, sterile supply)• 0360, Operating room services (ie, general classification)• 0370, Anesthesia (ie, general classification)• 0409, Other imaging services (ie, other imaging services)• 0636, Pharmacy (ie, drugs requiring detailed coding†)† For Field 43, NDC reporting requirements may vary by payer.

NOTE: Other revenue codes may apply.

Field 44: Enter the appropriate HCPCS code corresponding to the revenue code 0636 (Pharmacy: drugs requiring detailed coding) in order to provide detailed level coding; for example:• J2326, Injection, nusinersen, 0.1mg

Fields 74-74E: Enter appropriate principal and other ICD-10-PCS procedure codes (along with corresponding dates); for example:• 3E0R3GC, Introduction of other therapeutic

substance into spinal canal, percutaneous approach • BR13YZZ, Fluoroscopy of lumbar disc(s) using other

contrast • 3E0F7DZ, Introduction of inhalation anesthetic into

respiratory tract, via natural or artificial opening NOTE: Other ICD-10-PCS procedure codes may apply; for example:• BR49ZZZ, Ultrasonography of lumbar spine

Field 4: Enter the appropriate type of bill code; for example*:• 011X, Hospital inpatient• 014X, Hospital other* X represents a placeholder for the fourth digit,

which indicates the sequence of this bill in this particular episode of care (eg, “1” for admit through discharge claim).

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CLAIM SUBMISSION AND TRACKING CHECKLISTSCompleting timely and accurate claims can help facilitate prompt payment. In order to help proactively prevent denials and underpayment, it is important to review claims before submitting them to a payer.

CLAIM SUBMISSION CONSIDERATIONS CHECKLIST

Confirm payer requirements

During the Benefits Investigation process, confirm that you have identified the following:

Coverage and any PA restrictions Coding and billing guidelines Required medical documentation

Check claim for accuracy and completeness

When filling out the claim form, please double-check the following:

Patient information (eg, patient name, insurer, subscriber name, date of birth, member ID) Provider information (eg, NPI number, name, address, place of service) Coding (eg, ICD-10, CPT®, revenue, and/or HCPCS codes along with appropriate modifiers) Billing units (consistent with the descriptors for the reported CPT® and/or HCPCS codes) Additional information required by the payer (eg, PA, Tax ID and/or drug NDC number)

Confirm compliance with claim

submission rules

When submitting the claim, be mindful of the following:

Required standards for electronic claims Punctuation and character limit requirements Time frame for submitting claims

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CLAIM TRACKING CONSIDERATIONSTracking payer reimbursement for therapies and treatments is key for facilitating appropriate payment. It is important for offices to check payers’ EOB/RA statements for accuracy in order to detect any claims processing errors or inappropriate adjustments and to monitor for denials.

The following is a list of considerations for tracking claims:

Establish a routine procedure for monitoring the status of claims

Maintain a log of all correspondence with each payer for each claim. This will enable your office to monitor payer contract compliance

Review payer EOB/RA against contracted fee schedules

Evaluate payer responsiveness in addressing reimbursement issues

Establish a procedure for addressing claims denials and submitting appeals

Consider using the Biogen Reimbursement Tracking Log, located at SPINRAZA-hcp.com, to reconcile drug and procedure claims for SPINRAZA.

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http://SPINRAZA-hcp.com

MEDICARE AND SMA

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HOW PATIENTS APPLY FOR MEDICARE• Most people with SMA who are receiving SSDI benefits are automatically enrolled in Original Medicare (Parts A and B)31

— Patients who receive SSDI get Part A at no cost but have to pay a premium for Parts B and D. If patients don’t want the Part B premium automatically deducted from their SSDI, they can call Medicare to opt out of Part B

• Patients will be enrolled by the 25th month of receiving SSDI. They will get their Medicare card in the mail31

• Patients also get a notice in the mail about their Part D drug plan. It will tell them how to review or change it

If patients are not disabled, they will need to enroll in Medicare. They can sign up in 2 ways31:• Call the Social Security office at 1-800-772-1213• Sign up online at https://www.ssa.gov/planners/retire/justmedicare.html

• SMA Types 0 and 1 qualify as compassionate allowance for social security disability (1 of more than 200 conditions); it is automatic in many states33

• State-based qualification parameters also apply• To learn about disability benefits through Social Security, contact 1-800-772-1213 or

https://www.ssa.gov/benefits/disability/

• Children with SMA who are younger than 18 years can qualify for Supplemental Security Income (SSI) if they meet SSDI requirements and their income and resources fall within the eligibility limits30

• Children who were receiving benefits as a minor child on a parent’s Social Security record (via SSI) may be eligible to continue receiving benefits on that parent’s record upon reaching age 18 if they are disabled30

• Marriage of the disabled “adult child” may affect eligibility for this benefit• Medicare covers about 1 in 4 adults with SMA (aged 18 years and older)

MEDICARE ELIGIBILITY FOR PATIENTS WITH SMA*†

People younger than 65 years who have received Social Security Disability Insurance (SSDI) benefits for at least 2 years (24 months)30

• For these patients, enrollment in Medicare is automatic31

People aged 65 years or older30

WHO IS ELIGIBLE?

A PERSON CAN QUALIFY FOR SSDI BENEFITS IF

He or she has a past work history32He or she can no longer work due to his or her disability32

*Please note that Maryland follows the terms of the Maryland All-Payer Model and some of the following information may not apply.† Medicare providers and suppliers are not permitted to bill people enrolled in the Qualified Medicare Beneficiary program for items such as Medicare copays, deductibles, or coinsurance.

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Part A is hospital insurance. It covers inpatient care in a hospital, nursing home care, hospice care, and home healthcare. Part A covers SPINRAZA when patients receive it as an inpatient during a hospital stay.

Part B is medical insurance. Part B covers outpatient care (doctor’s office visits and visits to treatment centers for injections, some home healthcare services, medical equipment, wellness services, lab tests, and select preventive screenings). Part B covers SPINRAZA when patients receive it as an outpatient, for instance, at an SMA treatment center.

Parts A and B are known as “Original Medicare.” Patients will have Original Medicare unless they choose a Medicare Advantage Plan or other type of Medicare health plan.

Part C is also called Medicare Advantage. Part C plans are sold by private insurance companies approved by Medicare. These plans include all services covered under Part A and Part B. Part C may offer additional benefits, as well. Patients usually get prescription drug coverage (Part D) through a Medicare Advantage plan. See the following page for more detailed information about Medicare Advantage plans.

Part D is prescription drug coverage. Part D covers drug costs (pills, self-administered injections, and inhaled treatments). Part D plans are sold by private insurance companies approved by Medicare. These plans do not cover SPINRAZA, but they cover other drugs patients may need.

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B

C

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MEDICARE BASICSHOW DOES MEDICARE WORK?

Medicare has 4 parts to help cover services31:

SMA360° can help patients navigate Medicare options. Patients can call 1-844-4SPINRAZA (1-844-477-4672), Monday through Friday, from 8:30 am to 8:00 pm ET.

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UNDERSTANDING THE DIFFERENT TYPES OF MEDICARE ADVANTAGE PLANS (PART C)There are many types of Medicare Advantage plans. Each type of plan provides varying levels of coverage and operates in a unique way. Medicare Advantage plans offer the same benefits patients get under original Medicare (Part A and Part B), except hospice care. Medicare Advantage plans may also include other benefits such as prescription drug coverage, dental, and vision.31

Medicare Advantage plans may help keep copayments low. Each plan comes with a maximum OOP limit on how much patients will spend on health costs each year. Once patients reach the limit, they will pay nothing for the services covered. Each plan has different limits, and the OOP amount can change each year.31

The different types of Medicare Advantage plans include those outlined in the table below.

How each Medicare Advantage plan works

Types of commercial health plans

Has a network of providers?

Need a referral to see a specialist?

What happens if a patient needs out-of-network care?

HMO34 Yes Yes

HMOs may cover out-of-network care if• The HMO’s network of HCPs does not have the

experience to treat a certain health problem• The patient has an emergency

PPO35 Yes No

PPOs provide out-of-network care, but may not pay for the full cost of treatment. If the patient chooses to see an out-of-network HCP, he or she may have to pay for some of the treatment, even if it is an emergency

Private Fee-for-Service (PFFS)36

Depends on Plan

No

These plans are also offered by private insurance companies. PFFS plans aren’t the same as Original Medicare or Medigap. PFFS plans determine how much they will pay HCPs, other healthcare providers, and hospitals, and how much the patient will pay when receiving care

Special Needs Plan (SNP)37 Yes Yes

These plans limit membership to people with certain characteristics or specific diseases such as SMA. SNPs tailor their benefits, provider choices, and drug formularies to best meet the specific needs of the groups they serve

HMO Point of Service (HMOPOS)38

Yes No HMOPOS plans provide out-of-network care, but patients may have higher costs for out-of-network providers

Medical Savings Account (MSA)39 No No

These plans combine a high-deductible health plan with a bank account. Medicare deposits money into the account (usually less than the deductible). Patients can use the money to pay for healthcare services during the year

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A MEDIGAP POLICY MAY HELP PATIENTS PAY FOR TREATMENT COSTS NOT COVERED BY ORIGINAL MEDICAREMedicare Supplement Insurance policies, also known as Medigap policies, can help pay some of the costs Original Medicare does not. This includes copayments, coinsurance, and deductibles. Medigap policies are sold by private insurance companies. They must follow federal and state laws.31

Facts about Medigap policies

Medigap policies are not available to people covered

by a Medicare Advantage Plan (Part C)31

Patients must have Medicare Part A and Part B to have a Medigap Policy31

Patients cannot purchase a Medigap policy along with

a Medicare MSA40

CONTINUING SPINRAZA TREATMENT WHEN INSURANCE CHANGESIt is important to track and understand changes in health insurance for your patients with SMA, including primary and secondary insurance plans• For example, patients with SMA may transition to Medicare from Medicaid; Medicare becomes the primary

insurer and Medicaid is the secondary insurer• Patients with SMA may require authorization for treatment due to the change in health insurance• Insurance claims submitted to the wrong primary insurer will likely be rejected and will need to be

resubmitted to the correct insurer, causing a significant delay in reimbursement

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THE EXTENT OF WHAT MEDICARE COVERS DEPENDS ON WHETHER IT IS PAYING AS A PRIMARY OR SECONDARY PAYER • Medicare as the primary payer pays up to the limits of its coverage31

• Hospital coverage (Part A) • Physician visits, outpatient services, and physician-administered drugs like SPINRAZA (Part B) • Self-administered prescription drugs, which do not include SPINRAZA (Part C)

• Coverage gaps still exist with Medicare as primary payer31,41

• Patients can cover gaps with secondary payer/supplemental insurance (eg, employer-sponsored health plan, Medigap policy)

• Medicare as the secondary payer • Main role is to close the gap in OOP expenses31

• Pays only if there are costs not covered by the primary insurer31

• Medicare coinsurance will still apply31

• Covers claims when primary payment is delayed or in dispute42

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HOSPITAL REIMBURSEMENT FOR SPINRAZA

SPINRAZA HAS PASS-THROUGH STATUS FOR 340B THROUGH 2020 As of January 1, 2018, Medicare pays an adjusted amount of the average sales price (ASP) minus 22.5% for certain separately payable drugs or biologics acquired through the 340B program and furnished to a Medicare beneficiary by a hospital paid under the Outpatient Prospective Payment System (OPPS) that is not exempt from the payment adjustment policy.25

• However, SPINRAZA has pass-through status through June 30, 2020, and is not subject to this adjusted amount43

• When administered in the outpatient setting, Medicare reimbursement for SPINRAZA is set at ASP+6%25

• The Centers for Medicare & Medicaid Services (CMS) has established the HCPCS informational modifier “TB” for pass-through drugs (assigned status indicator “G”) acquired with a 340B discount at most hospitals25

• On July 1, 2020, if the rule to the 340B program is not revised, SPINRAZA will be reimbursed at ASP minus 22.5% (instead of ASP+6%) for 340B-purchased drugs only for Medicare patients treated at affected sites of care25,43

• For more information about billing 340B-acquired drugs (and use of modifiers), visit https://www.cms.gov/medicare/medicare-fee-for-service-payment/hospitaloutpatientpps/downloads/billing-340b-modifiers-under-hospital-opps.pdf

UNDERSTANDING APCs VS DRGs (BUNDLED PAYMENTS)• Ambulatory Payment Classifications (APCs) are the government’s way to pay facilities for outpatient services

under the Medicare program44

• Hospital-only, OPPS – SPINRAZA is allowed separate payment in the hospital outpatient department setting • No impact on physician payments under the Medicare Physician Fee Schedule • APC payments are made to the hospital when a Medicare outpatient is discharged or is transferred

to another hospital or facility not affiliated with the initial hospital where the patient received outpatient services

• Inpatient stays are paid under DRG methodology rather than APC.44 DRG payments do not allow separate payment for drugs administered during an inpatient stay45

• Medicare inpatient stays are subject to the 3-day rule. All outpatient services during the 3 days prior to an inpatient stay need to be incorporated into the inpatient DRG stay45

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DID YOU KNOW

ORIGINAL MEDICARE PATIENTS’ OOP COSTS ARE CAPPED IN THE HOSPITAL OUTPATIENT SETTING• OOP costs for patients receiving SPINRAZA in this treatment setting may

be limited to the Medicare Part A deductible • Typically, outpatient facility claims process under Part B benefits, so

beneficiaries who do not have supplemental insurance (eg, Medigap) are responsible for a 20% coinsurance (Medicare Part B covers 80%)41

• However, in the outpatient facility setting, if the patient’s coinsurance under Medicare Part B exceeds the Medicare Part A deductible, then the patient pays the Part A deductible and Medicare pays the difference.41,46 This may significantly reduce OOP costs

• Although hospital outpatient department claims for SPINRAZA are still covered under Medicare Part B, the claims are submitted to the Part A Medicare Administrative Contractor (MAC)

?

If your patient has original Medicare and is being treated in the hospital outpatient setting, you cancontact Medicare to find out the current Part A deductible amount he or she would pay. Call 1-800-MEDICARE or 1-800-633-4227.

Resources to determine the actual cost savings for patients treated in the outpatient setting are available from your Biogen representative.

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NATIONAL COVERAGE DETERMINATIONS• CMS contracts with private companies known as MACs to process and pay claims47

• CMS issues National Coverage Determinations (NCDs)47

• An NCD describes the circumstances under which a particular item or service (eg, a drug) is covered nationally under Medicare47

• NCDs apply to all MACs nationwide47

• CMS has not issued an NCD for SPINRAZA

HOW PART A AND PART B BENEFITS ARE ADMINISTERED UNDER ORIGINAL MEDICAREMACs process Medicare Part A and Part B (A/B) claims for a defined geographic area or “jurisdiction.”48

There are 2 types of MACs:• A/B MACs process Part A and Part B claims for a defined geographic area servicing institutional providers,

physicians, practitioners, and suppliers48

• Durable Medical Equipment (DME) MACs process Medicare Durable Medical Equipment, Orthotics, and Prosthetics (DMEPOS) claims for a defined geographic area servicing suppliers of DMEPOS48

There are 7 A/B MACs covering a total of 12 jurisdictions49

• Claims for SPINRAZA are processed by A/B MACs. Each MAC may have its own rules for coverage, billing/coding, etc47

• Healthcare insurers can be awarded more than 1 jurisdiction to process claim49

MACs AND MEDICAL POLICY

• Regional MACs may review SPINRAZA claims on a case-by-case basis until they issue an LCD or CMS issues an NCD with conditions for coverage

CMS-issued NCDs apply to all MACs nationwide47

• If an NCD does not exist or needs to be defined further, MACs can issue a Local Coverage Determination (LCD)

• An LCD is a coverage policy representing the MAC’s decision to cover or exclude a particular item or service and is applicable only within its jurisdiction

MACs can impact medical policy48

• Establish LCDs

• Handle first-stage appeals process

• Review medical records for selected claims

NATIONAL AND LOCAL COVERAGE DETERMINATIONS

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NOVITAS SOLUTIONS: AN EXAMPLE OF AN LCD FOR SPINRAZA• One MAC, Novitas Solutions, has issued an LCD for SPINRAZA• Novitas coverage of SPINRAZA includes Arkansas, Colorado, Louisiana, Maryland, New Jersey, Mississippi,

New Mexico, Oklahoma, Pennsylvania, Texas, and Washington, DC• The Novitas LCD has been effective since September 14, 2018

Coverage details• SPINRAZA is considered reasonable and necessary for intrathecal administration for initial coverage when

all of the following criteria are met50: • The patient is diagnosed with SMA Type 1, 2, or 3

• The SMA diagnosis is confirmed by genetic test result of either – Homozygous deletion of the SMN1 gene, or – Presence of a single copy of the SMN1 gene with coding confirming a mutation to mimic a

homozygous deletion of the SMN1 gene • Treatment is prescribed by a neurologist or physical medicine rehabilitation physician with a subspecialty

certification in neuromuscular medicine

• Dose does not exceed 12 mg every 4 months after the loading doses

Note: These criteria for coverage apply to the initial treatment phase, which is defined as completion of the loading doses followed by 3 maintenance doses administered 4 months apart.

• Continuation of SPINRAZA after completion of the initial treatment phase is considered reasonable when all of the criteria above are met and there is documented improvement or stability in motor function or a slower rate of decline in motor function due to SPINRAZA treatment as measured on a standard scale of SMA-associated symptoms50

SMN1=survival motor neuron 1.

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NOVITAS SOLUTIONS: AN EXAMPLE OF AN LCD FOR SPINRAZA (cont’d)

Utilization guidelines50

• In accordance with CMS ruling 95-1 (V), utilization of these services should be consistent with locally acceptable standards of practice

• For the first 12 months of treatment, no more than 6 doses of SPINRAZA will be considered reasonable and necessary

• After the first 12 months of treatment, no more than 3 doses of SPINRAZA in a rolling 12-month period of time will be considered reasonable and necessary

Medicare Advantage plans• There are separate rules governing Medicare Advantage plans, as indicated below

When there is an LCD (such as Novitas Solutions) and no NCD

Medicare Advantage plans in the same jurisdiction as the MAC must follow the LCD policy.

When there is no LCD and no NCD Medicare Advantage plans may restrict coverage of SPINRAZA as they see fit.➡

➡

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SAMPLE SPINRAZA START FORM

THE FOLLOWING INFORMATION MUST BE COMPLETED BY YOUR HEALTHCARE PROVIDER IN ORDER TO RECEIVE BIOGEN SERVICES.

TREATMENT DATEPlease provide the expected date of the next scheduled SPINRAZA dose.

Date

SITE OF CARE

Facility name

Address

City State ZIP code

Telephone Fax

NPI # Tax ID #

PROCUREMENT Specialty pharmacy— optional prescription below

Direct buy—order must be submitted Unknown

PLACE OF SERVICE (POS) CODE Physician office (11) Outpatient off-campus clinic (19) Inpatient (21) Observation a possibility in lieu of inpatient admission? Yes No Outpatient on campus (ie, infusion, short stay, surgical suite) (22) Ambulatory surgical center (24) Other

Once complete, submit by fax or email: 1-888-538-9781 [email protected]

AUTHORIZATION TO SHARE HEALTH INFORMATION FOR PATIENT SUPPORT SERVICES AND MARKETING/OTHER COMMUNICATIONSI have read and understand the Authorization to Share Health Information for Patient Support Services and Marketing/Other Communications and agree to the terms. A signature is required in order to receive Biogen services.

Signature of patient or parent/guardian (if under 18) Date

In addition, I authorize the disclosure of my health information to the following designated individual(s) (optional):

Name (print) Relationship

Name (print) Relationship

OPT-IN FOR AUTOMATED MARKETING MESSAGES

PATIENT INFORMATION

First name Last name

Male Female Date of birth

Spanish is my primary language

I have read and understand the Opt-In for Automated Marketing Calls and Text Messages and hereby agree to receive these types of communications from Biogen (optional).

Questions? Contact Biogen at: 1-844-4SPINRAZA (1-844-477-4672) START FORM

PRESCRIBER AUTHORIZATION (REQUIRED)I authorize Biogen as my designated agent on behalf of my patient to furnish any information on this form to his/her insurer.I will either administer treatment or supervise the treatment accordingly.

Prescriber signature Date

Signature stamps not acceptable. 11/17 SPZ-US-0266V2


Address

City State ZIP code

Telephone Fax

Email

NPI # State license #

Tax ID # Clinic/hospital affiliation

ADMINISTERING PHYSICIAN INFORMATION


Specialty Care coordinator contact

Telephone Fax

NPI # Tax ID #

MEDICAL INSURANCE INFORMATION*Disease type: 1 2 3 4 Genetic test on file

Primary insurance Policy #

Group # Insurance company telephone

Policyholder’s first name Policyholder’s last name

Secondary insurance Policy #/group #

Medicaid/governmental payer *Please remember to include front and back copy

of insurance card(s) along with this Start Form.

PRESCRIBER INFORMATION

PRESCRIPTION FOR SPECIALTY PHARMACY (OPTIONAL)†

SPINRAZA (nusinersen) injection 12 mg/5 mL (2.4 mg/mL) in a single-dose vial: Loading doses (4 doses) 1 year of SPINRAZA with maintenance doses (3 doses) 1 year of SPINRAZA with loading doses (6 doses)

Refills Inject SPINRAZA treatment with 4 loading doses. The 1st 3 loading doses should be administered at 14-day intervals. The 4th should be administered 30 days after the 3rd dose. A maintenance dose should be administered every 4 months. For more information, please refer to the Prescribing Information. Prescriber signature (dispense as written) Prescriber signature (substitution allowed) Name (print) Date

† In New York, please attach copies of all prescriptions on Official New York State Prescription Forms.

CONTACT INFORMATION

Email address

Home telephone Mobile phone

Address

City State ZIP code

OK to leave message

The SPINRAZA Start Form must always be accompanied by the consent information. Please contact your Biogen representative for a copy of this document or download from SPINRAZA-hcp.com.

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© 2018 Biogen. All rights reserved. SPZ-US-0644 02/18 Effective February 2018

PATIENT INFORMATION

First Name Last Name

□ Male □ Female Date of Birth

PATIENT ASSIGNED Program GROUP # PATIENT ASSIGNED Program ID #

This claim reimbursement form is for:(Please check the appropriate boxes)

□ Drug Copay Program

□ Classified Drug Codes – J2326 or C9489 Requested reimbursement amount: $

□ Unclassified Drug Codes – J3490, J3590, or C9399 Requested reimbursement amount: $

□ NDC 64406-058-01 & 64406-0058-01 Requested reimbursement amount: $

□ Procedure Copay Program

□ Anesthesia

□ Inhalation – 00635 Requested reimbursement amount: $

□ IV Sedation – 99100 Requested reimbursement amount: $

□ REV – 370 Requested reimbursement amount: $

□ Imaging Procedure/Guidance

□ Fluoroscopy – 77003 Requested reimbursement amount: $

□ Ultrasound – 76942 Requested reimbursement amount: $

□ CT Guidance – 77012 Requested reimbursement amount: $

□ Surgical Procedure and Drug Admin

□ Intrathecal drug admin – 96450 Requested reimbursement amount: $

□ Lumbar puncture, diagnostic – 62270 Requested reimbursement amount: $

□ Lumbar puncture, therapeutic – 62272 Requested reimbursement amount: $

□ Injection(s), without imaging guidance – 62322 Requested reimbursement amount: $

□ Injection(s), with imaging guidance – 62323 Requested reimbursement amount: $

CONTACT INFORMATION(For individual submitting this form)

First Name Last Name

Email Address

Primary Phone Fax #

Best time to contact □ Morning □ Afternoon □ Evening

PAYEE INFORMATIONFor reimbursement of the drug and/or procedure indicated here, the check should be sent to:

Clinic/Hospital affiliation

Address

City

State ZIP Code Telephone

NPI # (Required information) State License #

Tax ID # Fax #

EC15601001

*THE SPINRAZA COPAY AND PROCEDURE ASSISTANCE PROGRAM IS TO BE USED ONLY IN CONJUNCTION WITH A COMMERCIAL PAYER*

List name checks payable to. Note: Payments are made to physicians or site of care facilities only on behalf of the patient.

Copay Reimbursement FormPhone: 1-844-477-4672

Date of Service (DOS):! SUBMIT VIA FAX to 1-888-656-4343

Submit EOB or Remittance Advice along with summary of billed charges AND copy of reimbursement claim form

SAMPLE SPINRAZA COPAY REIMBURSEMENT FORM

Please see your Biogen representative for a copy of the Copay Reimbursement Form.

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SAMPLE LETTERS OF MEDICAL NECESSITY

SPZ-US-0309 05/18

[TEMPLATE

Letter of Medical Necessity: Use of SPINRAZA® (nusinersen) for Spinal Muscular Atrophy

(Treatment Naive)]

Date:

[Name of Medical Director] RE: Patient Name [ ]

[Health Plan] Policy Number [ ]

[Address] Claim Number [ ]

[City, State, Zip]

Dear [Health Plan]:

I am writing this letter of medical necessity in support of my request to treat

[patient name] with SPINRAZA® (nusinersen), the only United States Food and Drug

Administration (FDA)–approved treatment for spinal muscular atrophy (SMA) in

pediatric and adult patients.

[Note: Include information about your credentials, specialty, practice, and

number of patients with SMA you follow and treat.]

1. Patient-Specific Rationale for Treatment

[Note: Exercise your medical judgment and discretion when providing a

diagnosis and characterization of the patient’s medical conditions. As a best

practice, provide your clinical rationale for treatment while considering the

health plan’s medical policy criteria for SPINRAZA.] In brief, based on the clinical data available to date, it is my medical opinion that

initiating treatment with SPINRAZA for [patient name] is medically appropriate and

necessary, and the procedures required for its administration should be a covered and

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[TEMPLATE

Letter of Medical Necessity: Use of SPINRAZA® (nusinersen) for Spinal Muscular Atrophy

(Secondary Health Plan After Primary Health Plan Has Denied Coverage)]

Date:


[Secondary Health Plan] Policy ID Number [ ]

[Address] [City, State, Zip]

Secondary Health Plan Policy ID Number [________________________________]

Secondary Health Plan Phone Number [__________________________________]

Dear [Secondary Health Plan]:

This letter is to request prior authorization (PA) of treatment with SPINRAZA®

(nusinersen) for your member, [patient name]. This patient currently has primary

medical coverage with [health plan], which has denied [#] requests for coverage of

SPINRAZA for this patient. Therefore, I am requesting a determination of medical

necessity for SPINRAZA and coverage at full benefits, rather than the usual

coinsurance amounts, due to the primary health plan’s denial.



Primary Health Plan Coverage Attempts Exhausted

I fully appreciate that, as a secondary health plan, you want to ensure that all

coverage possibilities through the primary plan have been exhausted prior to a patient

SAMPL

E

SPZ-US-1470 05/18

[TEMPLATE

Letter of Medical Necessity:

Use of SPINRAZA® (nusinersen) for Spinal Muscular Atrophy (Appealing a Clinical Criteria-Based Denial)]

Date: [Name of Medical Director] RE: Patient Name [__________________________]

[Health Plan] Policy Number [_______________________]

[Address] Claim Number [_______________________]

[City, State, Zip] Diagnosis [_________________________]

ICD-10-CM Code [_____________________]

[Note: This appeal letter should be written after fully reviewing the health plan’s denial letter and medical policy for SPINRAZA.]

Dear [Health Plan]:

I am writing on behalf of [patient name] to request reconsideration of a denial of

coverage for SPINRAZA® (nusinersen), the only United States Food and Drug Administration

(FDA)–approved treatment for spinal muscular atrophy (SMA) in pediatric and adult patients.

As a board certified [field of certification] with [#] years caring for patients with SMA,

I have prescribed SPINRAZA for this patient based on my clinical judgment and expertise.

However, you have indicated that SPINRAZA is not covered by [patient’s health plan] because [reason for denial letter from patient’s explanation of benefits]. The approval of

coverage is requested because I believe that treatment with SPINRAZA is medically

necessary for [patient name]. To illustrate the appropriateness of this treatment, I would like to provide

important details relevant to this particular patient, as well as information about SMA

and SPINRAZA.

SAMPL

E

SPZ-US-1505 05/18

[TEMPLATE

Letter of Medical Necessity:

Use of SPINRAZA® (nusinersen) for Spinal Muscular Atrophy

(Reauthorization)]

Date:


[Health Plan] Policy Number [ ]

[Address] Claim Number [ ]

[City, State, Zip]

Dear [Health Plan]: I am writing this letter of medical necessity to provide information related to

continuing the treatment of [patient name] with SPINRAZA® (nusinersen), the only

US Food and Drug Administration (FDA)–approved treatment for spinal muscular

atrophy (SMA).



1. Summary of Patient’s History [You may want to include]:

• Patient’s diagnosis, condition, and relevant medical history, including observed

functional loss prior to treatment

• Previous treatment history with SPINRAZA

• Brief description of the patient’s symptoms and conditions before SPINRAZA and while

on SPINRAZA treatment

[Patient name] receives a maintenance dose of SPINRAZA via an intrathecal

SAMPL

E

Please contact your Biogen representative for copies of these documents.

For use when requesting an exception to the plan’s published criteria for SPINRAZA, which may be necessary for certain patients to receive SPINRAZA.

For use when requesting coverage for SPINRAZA from a secondary payer when attempts for primary insurance coverage have been exhausted.

For use when appealing a denial of coverage for SPINRAZA.

For use to help achieve reauthorization for patients who have previously received SPINRAZA.

Sample Treatment-Naive Letter

Sample Secondary Payer Authorization Request Letter

Sample Appeal Letter

Sample Reauthorization Letter

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757575

INDICATIONSPINRAZA® (nusinersen) is indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients.

IMPORTANT SAFETY INFORMATIONCoagulation abnormalities and thrombocytopenia, including acute severe thrombocytopenia, have been observed after administration of some antisense oligonucleotides. Patients may be at increased risk of bleeding complications. In the sham-controlled studies for patients with infantile-onset and later-onset SMA, 24 of 146 SPINRAZA-treated patients (16%) with high, normal, or unknown platelet count at baseline developed a platelet level below the lower limit of normal, compared to 10 of 72 sham-controlled patients (14%). Two SPINRAZA-treated patients developed platelet counts <50,000 cells per microliter, with the lowest level of 10,000 cells per microliter recorded on study day 28.Renal toxicity, including potentially fatal glomerulonephritis, has been observed after administration of some antisense oligonucleotides. SPINRAZA is present in and excreted by the kidney. In the sham-controlled studies for patients with infantile-onset and later-onset SMA, 71 of 123 SPINRAZA-treated patients (58%) had elevated urine protein, compared to 22 of 65 sham-controlled patients (34%). Laboratory testing and monitoring to assess safety should be conducted. Perform a platelet count, coagulation laboratory testing, and quantitative spot urine protein testing at baseline and prior to each dose of SPINRAZA and as clinically needed.Severe hyponatremia was reported in an infant treated with SPINRAZA requiring salt supplementation for 14 months.Cases of rash were reported in patients treated with SPINRAZA. SPINRAZA may cause a reduction in growth as measured by height when administered to infants, as suggested by observations from the controlled study. It is unknown whether any effect of SPINRAZA on growth would be reversible with cessation of treatment.The most common adverse reactions (≥20% of SPINRAZA-treated patients and ≥5% more frequently than in control patients) that occurred in the infantile-onset controlled study were lower respiratory infection and constipation. Serious adverse reactions of atelectasis were more frequent in SPINRAZA- treated patients (18%) than in control patients (10%). Because patients in this controlled study were infants, adverse reactions that are verbally reported could not be assessed. The most common adverse reactions that occurred in the later-onset controlled study were pyrexia, headache, vomiting, and back pain. Post-lumbar puncture syndrome has also been observed after the administration of SPINRAZA.

Please see enclosed full Prescribing Information.

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REFERENCES1. SPINRAZA [Prescribing Information]. Cambridge, MA: Biogen. 2. Rapaport C. An Introduction to Health Insurance: What Should a Consumer Know? https://www.fas.org/sgp/

crs/misc/R44014.pdf. Published April 30, 2015. Accessed April 8, 2019. 3. Glossary of health coverage and medical terms. Centers for Medicare & Medicaid Services website.

https://www.cms.gov/CCIIO/Resources/Files/Downloads/uniform-glossary-final.pdf. Accessed April 8, 2019. 4. The Lewin Group, Inc. Medicaid Non-emergency Out-of-Network Payment Study. http://www.lewin.com/

content/dam/Lewin/Resources/Site_Sections/Publications/OutofNetworkStudyReport.pdf. Published July 13, 2009. Accessed April 8, 2019.

5. Biogen, Data on file. SMA payer and channel strategic issues. Published January 28, 2016. 6. Course 3: Medical Billing Terminology. Medical Billing and Coding Online website.

http://www.medicalbillingandcodingonline.com/medical-billing-terminology/. Accessed April 8, 2019. 7. O’Hagen JM, Glanzman AM, McDermott MP, et al. An expanded version of the Hammersmith Functional

Motor Scale for SMA II and III patients. Neuromuscul Disord. 2007;17(9-10):693-697. 8. Glanzman AM, Mazzone E, Main M, et al. The Children’s Hospital of Philadelphia Infant Test of Neuromuscular

Disorders (CHOP INTEND): test development and reliability. Neuromuscul Disord. 2010;20(3):155-161. 9. Haataja L, Mercuri E, Regev R, et al. Optimality score for the neurologic examination of the infant at 12 and

18 months of age. J Pediatr. 1999;135(2 pt 1):153-161. 10. Biogen, Data on file. Nusinersen brand book. Volume 1. 11. SO-SMART: Significant Outcomes-Spinal Muscular Atrophy (SMA) readies for clinical trials workshop.

National Institute of Neurological Disorders and Stroke website. https://www.ninds.nih.gov/News-Events/Workshop-Conference-Proceedings/SO-SMART-Readies-Clinical-Trials-Workshop. Published June 11, 2014. Accessed April 8, 2019.

12. Mazzone ES, Mayhew A, Montes J, et al. Revised Upper Limb Module for spinal muscular atrophy: development of a new module. Muscle Nerve. 2017;55(6):869-874.

13. WHO Multicentre Growth Reference Study Group. WHO Motor Development Study: windows of achievement for six gross motor development milestones. Acta Paediatr Suppl. 2006;450:86-95.

14. Dunaway Young, S, Montes J, Kramer SS, et al. Six-minute walk test is reliable and valid in spinal muscular atrophy. Muscle Nerve. 2016;54(5):836-842.

15. Appealing a health plan decision: external review. Healthcare.gov website. https://www.healthcare.gov/appeal-insurance-company-decision/external-review/. Accessed April 8, 2019.

16. Patient Advocate Foundation. A Patient’s Guide to Navigating the Insurance Appeals Process. http://www.patientadvocate.org/requests/publications/Guide-Appeals-Process.pdf. Accessed April 8, 2019.

17. American Medical Association. CPT® 2019 Professional Edition. Chicago, IL: American Medical Association; 2018.

18. Department of Health & Human Services, Centers for Medicare & Medicaid Services. CMS Manual System: Uniform Billing (UB-04) Implementation. Transmittal 1104. https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/R1104CP.pdf. Published November 3, 2006. Accessed April 8, 2019.

19. Dixon D, Wright P. National Drug Code reporting requirements [presentation]. January 2009. https://files.medi-cal.ca.gov/pubsdoco/ndc/pdf/10060_ndc_powerpoint.pdf. Accessed April 8, 2019.

20. ICD-10-CM tabular list of diseases and injuries. Centers for Medicare & Medicaid Services website. https://www.cms.gov/Medicare/Coding/ICD10/2018-ICD-10-CM-and-GEMs.html. Accessed April 8, 2019.

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REFERENCES (cont’d)21. Centers for Medicare & Medicaid Services (CMS) Healthcare Common Procedure Coding System (HCPCS)

application summaries for drugs, biologicals and radiopharmaceuticals. https://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/Downloads/2017-05-17-HCPCS-Application-Summary.pdf. Published May 17, 2017. Accessed April 8, 2019.

22. Academy of Managed Care Pharmacy. AMCP Guide to Pharmaceutical Payment Methods, 2013 Update. Version 3.0. http://www.amcp.org/pharmaceutical-payment-guide. Accessed April 8, 2019.

23. Butler K, Davis G, Loftis J, Spector N. A “how to” for reporting NDC in health care claims [presentation]. May 1, 2013. https://www.wedi.org/forms/uploadFiles/2B3BC0000001E.toc.5.1_NDC_Webinar.pdf. Published May 1, 2013. Accessed April 8, 2019.

24. UnitedHealthcare. National Drug Code requirements. https://www.uhcprovider.com/content/provider/en/viewer.html?file=https%3A%2F%2Fwww.uhcprovider.com%2Fcontent%2Fdam%2Fprovider%2Fdocs%2Fpublic%2Fclaims%2FNDC-Requirement-FAQ.pdf. Accessed April 8, 2019.

25. Billing 340B modifiers under the Hospital Outpatient Prospective Payment System (OPPS): frequently asked questions. Centers for Medicare & Medicaid Services website. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Downloads/Billing-340B-Modifiers-under-Hospital-OPPS.pdf. Published April 2, 2018. Accessed April 8, 2019.

26. ASC 837I version 5010A2 Institutional Health Care Claim to the CMS-1450 Claim Form Crosswalk. Palmetto GBA website. https://www.palmettogba.com/Palmetto/Providers.Nsf/files/EDI_837I_v5010A2_crosswalk.pdf/$File/EDI_837I_v5010A2_crosswalk.pdf. Accessed April 8, 2019.

27. ASC 837 v5010 to CMS-1500 Crosswalk. Palmetto GBA website. https://www.palmettogba.com/Palmetto/Providers.Nsf/files/CMS1500_837v5010_Crosswalk.pdf/$File/CMS1500_837v5010_Crosswalk.pdf. Accessed April 8, 2019.

28. Place of Service codes for professional claims. Centers for Medicare & Medicaid Services website. https://www.cms.gov/Medicare/Coding/place-of-service-codes/Place_of_Service_Code_Set.html. Updated November 2016. Accessed April 8, 2019.

29. 2019 ICD-10-PCS Codes. ICD10Data.com website. http://www.icd10data.com/ICD10PCS/Codes. Accessed April 8, 2019.

30. Social Security Administration. Benefits for Children With Disabilities. https://www.ssa.gov/pubs/EN-05-10026.pdf. Accessed April 4, 2019.

31. Centers for Medicare & Medicaid Services. Medicare & You – 2019. https://www.medicare.gov/sites/default/files/2018-09/10050-medicare-and-you.pdf. Accessed April 4, 2019.

32. Benefits planner: disability. How you qualify. Social Security Administration website. https://www.ssa.gov/planners/disability/qualify.html. Accessed April 4, 2019.

33. Compassionate allowances conditions. Social Security Administration website. https://www.ssa.gov/compassionateallowances/conditions.htm. Accessed April 4, 2019.

34. The ins and outs of seeking out-of-network care. Patient Advocate Foundation website. https://www.patientadvocate.org/cardio-it-matters-sheets/the-ins-and-outs-of-seeking-out-of-network-care/. Accessed April 9, 2019.

35. Preferred provider organization (PPO). Medicare.gov website. https://www.medicare.gov/sign-up-change-plans/types-of-medicare-health-plans/preferred-provider-organization-ppo. Accessed April 4, 2019.

36. Private fee-for-service (PFFS) plans. Medicare.gov website. https://www.medicare.gov/sign-up-change-plans/types-of-medicare-health-plans/private-fee-for-service-pffs-plans. Accessed April 4, 2019.

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REFERENCES (cont’d)37. Special needs plans (SNPs). Medicare.gov website. https://www.medicare.gov/sign-up-change-plans/types-

of-medicare-health-plans/special-needs-plans-snp. Accessed April 4, 2019. 38. What’s the difference between Medicare HMO-POS and PPO plans? Priority Health website.

https://www.priorityhealth.com/medicare/medicare-explained/extra-credit/difference-between-hmo-pos-ppo#. Accessed April 12, 2019.

39. Different types of Medicare Advantage plans. Medicare.gov website. https://www.medicare.gov/sign-up-change-plans/types-of-medicare-health-plans/medicare-advantage-plans/different-types-of-medicare-advantage-plans. Accessed April 4, 2019.

40. How Medicare MSA plans work with other coverage. Medicare.gov website. https://www.medicare.gov/sign-up-change-plans/types-of-medicare-health-plans/how-medicare-msa-plans-work-with-other-coverage. Accessed April 4, 2019.

41. Medicare costs at a glance. Medicare.gov website. https://www.medicare.gov/your-medicare-costs/medicare-costs-at-a-glance. Accessed April 4, 2019.

42. Congressional Research Service. Medicare Secondary Payer: Coordination of Benefits. Report No. RL33587. https://www.everycrsreport.com/files/20140508_RL33587_a4115c77876940c4301dbae3244c3100d0d926ff.pdf. Published May 8, 2014. Accessed April 4, 2019.

43. Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and quality reporting programs, 81 Federal Register 79562 (2016).

44. APC (Ambulatory Payment Classification) FAQ. American College of Emergency Physicians website. https://www.acep.org/administration/reimbursement/reimbursement-faqs/apc-ambulatory-payment-classifications-faq/. Accessed April 4, 2019.

45. Centers for Medicare & Medicaid Services. Acute Care Hospital Inpatient Prospective Payment System. https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/AcutePaymtSysfctsht.pdf. Published February 2019. Accessed April 8, 2019.

46. Centers for Medicare & Medicaid Services. Chapter 4 – Part B hospital (including inpatient hospital Part B and OPPS). In: Medicare Claims Processing Manual. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c04.pdf. Revised March 15, 2019. Accessed April 4, 2019.

47. MACs Continue to Use Different Methods to Determine Drug Coverage. Department of Health and Human Services. Office of Inspector General. OEI-03-13-00450. https://oig.hhs.gov/oei/reports/oei-03-13-00450.pdf. Published August 2016. Accessed April 8, 2019.

48. What is a MAC. Centers for Medicare & Medicaid Services website. https://www.cms.gov/medicare/medicare-contracting/medicare-administrative-contractors/what-is-a-mac.html. Accessed April 4, 2019.

49. A/B MAC jurisdictions. Centers for Medicare & Medicaid Services website. https://www.cms.gov/Medicare/Medicare-Contracting/Medicare-Administrative-Contractors/Downloads/AB-MAC-Jurisdiction-Map-Oct-2017.pdf. Accessed April 4, 2019.

50. Local Coverage Determination (LCD): Nusinersen (Spinraza) (L37682). Centers for Medicare & Medicaid Services website. https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=37682&ver=6&DocID=L37682&bc=gAAAABAAAAAA&. Accessed April 4, 2019.

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1

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SPINRAZA® safely and effectively. See full prescribing information for SPINRAZA. SPINRAZA (nusinersen) injection, for intrathecal use Initial U.S. Approval: 2016 __________________ INDICATIONS AND USAGE _________________ SPINRAZA is a survival motor neuron-2 (SMN2)-directed antisense oligonucleotide indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients (1) _______________ DOSAGE AND ADMINISTRATION ______________ SPINRAZA is administered intrathecally (2.1)

Dosing Information (2.1) The recommended dosage is 12 mg (5 mL) per administration Initiate SPINRAZA treatment with 4 loading doses: the first three

loading doses should be administered at 14-day intervals; the 4th loading dose should be administered 30 days after the 3rd dose. A maintenance dose should be administered once every 4 months thereafter.

Important Preparation and Administration Instructions (2.2) Allow to warm to room temperature prior to administration Administer within 4 hours of removal from vial Prior to administration, remove 5 mL of cerebrospinal fluid Administer as intrathecal bolus injection over 1 to 3 minutes

Laboratory Testing and Monitoring to Assess Safety (2.3) At baseline and prior to each dose, obtain a platelet count, coagulation

laboratory testing, and quantitative spot urine protein testing

______________ DOSAGE FORMS AND STRENGTHS ______________ Injection: 12 mg/5 mL (2.4 mg/mL) in a single-dose vial (3) ___________________ CONTRAINDICATIONS____________________ None. _______________ WARNINGS AND PRECAUTIONS _______________ Thrombocytopenia and Coagulation Abnormalities: Increased risk for

bleeding complications; testing required at baseline and before each dose and as clinically needed (5.1, 2.3)

Renal Toxicity: Quantitative spot urine protein testing required at baseline and prior to each dose (5.2, 2.3)

____________________ ADVERSE REACTIONS ____________________ The most common adverse reactions that occurred in at least 20% of SPINRAZA-treated patients and occurred at least 5% more frequently than in control patients were:

lower respiratory infection and constipation in patients with infantile-onset SMA (6.1)

pyrexia, headache, vomiting, and back pain in patients with later-onset SMA (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Biogen at 1-844-477-4672 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. _______________ USE IN SPECIFIC POPULATIONS _______________

Pregnancy: Based on animal data, may cause fetal harm (8.1) See 17 for PATIENT COUNSELING INFORMATION.

Revised: 06/2019

FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION

2.1 Dosing Information 2.2 Important Administration Instructions 2.3 Laboratory Testing and Monitoring to Assess Safety

3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS

5.1 Thrombocytopenia and Coagulation Abnormalities 5.2 Renal Toxicity

6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 6.2 Immunogenicity 6.3 Postmarketing Experience

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.4 Pediatric Use 8.5 Geriatric Use

11 DESCRIPTION 12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES 14.1 Infantile-Onset SMA 14.2 Later-Onset SMA 14.3 Presymptomatic SMA 16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied 16.2 Storage and Handling

17 PATIENT COUNSELING INFORMATION *Sections or subsections omitted from the full prescribing information are not listed.

2

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

SPINRAZA is indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients.

2 DOSAGE AND ADMINISTRATION

2.1 Dosing Information SPINRAZA is administered intrathecally by, or under the direction of, healthcare professionals experienced in performing lumbar punctures.

Recommended Dosage

The recommended dosage is 12 mg (5 mL) per administration. Initiate SPINRAZA treatment with 4 loading doses. The first three loading doses should be administered at 14-day intervals. The 4th loading dose should be administered 30 days after the 3rd dose. A maintenance dose should be administered once every 4 months thereafter. Missed Dose

If a loading dose is delayed or missed, administer SPINRAZA as soon as possible, with at least 14-days between doses and continue dosing as prescribed. If a maintenance dose is delayed or missed, administer SPINRAZA as soon as possible and continue dosing every 4 months.

2.2 Important Preparation and Administration Instructions

SPINRAZA is for intrathecal use only.

Prepare and use SPINRAZA according to the following steps using aseptic technique. Each vial is intended for single dose only.

Preparation

Store SPINRAZA in the carton in a refrigerator until time of use. Allow the SPINRAZA vial to warm to room temperature (25o C/77o F) prior to

administration. Do not use external heat sources. Inspect the SPINRAZA vial for particulate matter and discoloration prior to

administration. Do not administer SPINRAZA if visible particulates are observed or if the liquid in the vial is discolored. The use of external filters is not required.

Withdraw 12 mg (5 mL) of SPINRAZA from the single-dose vial into a syringe and discard unused contents of the vial.

Administer SPINRAZA within 4 hours of removal from vial.

Administration

Consider sedation as indicated by the clinical condition of the patient.

3

Consider ultrasound or other imaging techniques to guide intrathecal administration of SPINRAZA, particularly in younger patients.

Prior to administration, remove 5 mL of cerebrospinal fluid. Administer SPINRAZA as an intrathecal bolus injection over 1 to 3 minutes using a

spinal anesthesia needle [see Dosage and Administration (2.1)]. Do not administer SPINRAZA in areas of the skin where there are signs of infection or inflammation [see Adverse Reactions (6.3)].

2.3 Laboratory Testing and Monitoring to Assess Safety Conduct the following laboratory tests at baseline and prior to each dose of SPINRAZA and as clinically needed [see Warnings and Precautions (5.1, 5.2)]:

Platelet count Prothrombin time; activated partial thromboplastin time Quantitative spot urine protein testing

3 DOSAGE FORMS AND STRENGTHS

Injection: 12 mg/5 mL (2.4 mg/mL) nusinersen as a clear and colorless solution in a single-dose vial.

4 CONTRAINDICATIONS

None.

5 WARNINGS AND PRECAUTIONS

5.1 Thrombocytopenia and Coagulation Abnormalities

Coagulation abnormalities and thrombocytopenia, including acute severe thrombocytopenia, have been observed after administration of some antisense oligonucleotides.

In the sham-controlled studies for patients with infantile-onset and later-onset SMA, 24 of 146 (16%) SPINRAZA-treated patients with high, normal, or unknown platelet count at baseline developed a platelet level below the lower limit of normal, compared to 10 of 72 (14%) sham-controlled patients.

In the sham-controlled study in patients with later-onset SMA (Study 2), two SPINRAZA-treated patients developed platelet counts less than 50,000 cells per microliter, with a lowest level of 10,000 cells per microliter recorded on study day 28.

Because of the risk of thrombocytopenia and coagulation abnormalities from SPINRAZA, patients may be at increased risk of bleeding complications.

4

Perform a platelet count and coagulation laboratory testing at baseline and prior to each administration of SPINRAZA and as clinically needed.

5.2 Renal Toxicity

Renal toxicity, including potentially fatal glomerulonephritis, has been observed after administration of some antisense oligonucleotides.

SPINRAZA is present in and excreted by the kidney [see Clinical Pharmacology (12.3)]. In the sham-controlled studies for patients with infantile-onset and later-onset SMA, 71 of 123 (58%) of SPINRAZA-treated patients had elevated urine protein, compared to 22 of 65 (34%) sham-controlled patients. Conduct quantitative spot urine protein testing (preferably using a first morning urine specimen) at baseline and prior to each dose of SPINRAZA. For urinary protein concentration greater than 0.2 g/L, consider repeat testing and further evaluation.

6 ADVERSE REACTIONS

The following serious adverse reactions are described in detail in other sections of the labeling:

Thrombocytopenia and Coagulation Abnormalities [see Warnings and Precautions (5.1)]

Renal Toxicity [see Warnings and Precautions (5.2)]

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of SPINRAZA cannot be directly compared to rates in clinical trials of other drugs and may not reflect the rates observed in practice.

The data described below reflect exposure to SPINRAZA in 260 patients (48% male, 80% Caucasian), including 227 exposed for at least 6 months and 181 exposed for at least 1 year. The safety of SPINRAZA was studied in presymptomatic infants with SMA; pediatric patients (approximately 3 days to 16 years of age at first dose) with symptomatic SMA; in a sham-controlled trial in infants with symptomatic SMA (Study 1; n=80 for SPINRAZA, n=41 for control); in a sham-controlled trial in children with symptomatic SMA (Study 2; n=84 for SPINRAZA, n=42 for control); in open-label studies in presymptomatic and symptomatic infants (n=40); and in open-label studies in later onset patients (n=56). In Study 1, 58 patients were exposed for at least 6 months and 28 patients were exposed for at least 12 months. In Study 2, 84 patients were exposed for at least 6 months and 82 patients were exposed for at least 12 months.

Clinical Trial in Infantile-Onset SMA (Study 1)

In Study 1, baseline disease characteristics were largely similar in the SPINRAZA-treated patients and sham-control patients except that SPINRAZA-treated patients at baseline had a higher percentage compared to sham-control patients of paradoxical breathing (89% vs 66%),

5

pneumonia or respiratory symptoms (35% vs 22%), swallowing or feeding difficulties (51% vs 29%), and requirement for respiratory support (26% vs 15%).

The most common adverse reactions that occurred in at least 20% of SPINRAZA-treated patients and occurred at least 5% more frequently than in control patients were lower respiratory infection and constipation. Serious adverse reactions of atelectasis were more frequent in SPINRAZA-treated patients (18%) than in control patients (10%). Because patients in Study 1 were infants, adverse reactions that are verbally reported could not be assessed in this study.

Table 1. Adverse Reactions that Occurred in at Least 5% of SPINRAZA Patients and Occurred at Least 5% More Frequently or At Least 2 Times as Frequently Than in Control Patients with Infantile-Onset SMA (Study 1)

Adverse Reactions SPINRAZA 12 mg1

N = 80

%

Sham-Procedure Control

N = 41

%

Lower respiratory infection2

55 37

Constipation 35 22

Teething 18 7

Urinary tract infection 9 0

Upper respiratory tract congestion

8 2

Ear infection 6 2

Flatulence 5 2

Decreased weight 5 2

1 Loading doses followed by 12 mg (5 mL) once every 4 months 2 Includes adenovirus infection, bronchiolitis, bronchitis, bronchitis viral, corona virus infection, Influenza, lower respiratory tract infection, lower respiratory tract infection viral, lung infection, parainfluenzae virus infection, pneumonia, pneumonia bacterial, pneumonia influenzal, pneumonia moraxella, pneumonia parainfluenzae viral, pneumonia pneumococcal, pneumonia pseudomonal, pneumonia respiratory syncytial viral, pneumonia viral, and respiratory syncytial virus bronchiolitis.

In an open-label clinical study in infants with symptomatic SMA, severe hyponatremia was reported in a patient treated with SPINRAZA requiring salt supplementation for 14 months. Cases of rash were reported in patients treated with SPINRAZA. One patient, 8 months after starting SPINRAZA treatment, developed painless red macular lesions on the forearm, leg, and foot over an 8-week period. The lesions ulcerated and scabbed over within 4 weeks, and resolved

6

over several months. A second patient developed red macular skin lesions on the cheek and hand ten months after the start of SPINRAZA treatment, which resolved over 3 months. Both cases continued to receive SPINRAZA and had spontaneous resolution of the rash. SPINRAZA may cause a reduction in growth as measured by height when administered to infants, as suggested by observations from the controlled study. It is unknown whether any effect of SPINRAZA on growth would be reversible with cessation of treatment. Clinical Trial in Later-Onset SMA (Study 2) In Study 2, baseline disease characteristics were largely similar in the SPINRAZA-treated patients and sham-control patients except for the proportion of SPINRAZA-treated patients who had ever achieved the ability to stand without support (13% vs 29%) or walk with support (24% vs 33%).

The most common adverse reactions that occurred in at least 20% of SPINRAZA-treated patients and occurred at least 5% more frequently than in control patients were pyrexia, headache, vomiting, and back pain.

7

Table 2. Adverse Reactions that Occurred in at Least 5% of SPINRAZA Patients and Occurred at Least 5% More Frequently or At Least 2 Times as Frequently Than in Control Patients with Later-Onset SMA (Study 2)

Adverse Reactions SPINRAZA 12 mg1

N=84

%

Sham-Procedure Control

N=42

%

Pyrexia 43 36

Headache 29 7

Vomiting 29 12

Back pain 25 0

Epistaxis 7 0

Fall 5 0

Respiratory tract congestion 5 2

Seasonal allergy 5 2 1 Loading doses followed by 12 mg (5 mL) once every 6 months Post-lumbar puncture syndrome has also been observed after administration of SPINRAZA.

6.2 Immunogenicity

As with all oligonucleotides, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to nusinersen in the studies described below with the incidence of antibodies in other studies or to other products may be misleading. The immunogenic response to nusinersen was determined in 249 patients with post-baseline plasma samples evaluated for anti-drug antibodies (ADAs). Sixteen patients (6%) developed treatment-emergent ADAs, of which 3 were transient,13 were considered to be persistent. Persistent was defined as having one positive test followed by another one more than 100 days after the first positive test. In addition, “persistent” is also defined as having one or more positive samples and no sample more than 100 days after the first positive sample. Transient was defined as having one or more positive results and not confirmed to be persistent. There are insufficient data to evaluate an effect of ADAs on clinical response, adverse events, or the pharmacokinetic profile of nusinersen.

8

6.3 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of SPINRAZA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Serious infections associated with lumbar puncture, such as meningitis, have been observed. Hydrocephalus, aseptic meningitis, and hypersensitivity reactions (e.g. angioedema, urticaria, rash) have also been reported.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

There are no adequate data on the developmental risk associated with the use of SPINRAZA in pregnant women. When nusinersen was administered by subcutaneous injection to mice throughout pregnancy and lactation, developmental toxicity (long-term neurobehavioral impairment) was observed at all doses tested (see Data). In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data

Animal Data

When nusinersen (0, 3, 10, or 25 mg/kg) was administered subcutaneously to male and female mice every other day prior to and during mating and continuing in females throughout organogenesis, no adverse effects on embryofetal development were observed. Subcutaneous administration of nusinersen (0, 6, 12.6, or 25 mg/kg) to pregnant rabbits every other day throughout organogenesis produced no evidence of embryofetal developmental toxicity. When nusinersen (1.4, 5.8, or 17.2 mg/kg) was administered to pregnant female mice by subcutaneous injection every other day throughout organogenesis and continuing once every six days throughout the lactation period, adverse neurobehavioral effects (alterations in locomotor activity, learning and memory deficits) were observed when offspring were tested after weaning or as adults. A no-effect level for neurobehavioral impairment was not established.

9

8.2 Lactation

Risk Summary

There are no data on the presence of nusinersen in human milk, the effects on the breastfed infant, or the effects of the drug on milk production.Nusinersen was detected in the milk of lactating mice when administered by subcutaneous injection. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SPINRAZA and any potential adverse effects on the breastfed infant from SPINRAZA or from the underlying maternal condition.

8.4 Pediatric Use

The safety and effectiveness of SPINRAZA in pediatric patients from newborn to 17 years have been established [see Clinical Studies (14.1)].

Juvenile Animal Toxicity Data

In intrathecal toxicity studies in juvenile monkeys, administration of nusinersen (0, 0.3, 1, or 3 mg/dose for 14 weeks and 0, 0.3, 1, or 4 mg/dose for 53 weeks) resulted in brain histopathology (neuronal vacuolation and necrosis/cellular debris in the hippocampus) at the mid and high doses and acute, transient deficits in lower spinal reflexes at the high dose in each study. In addition, possible neurobehavioral deficits were observed on a learning and memory test at the high dose in the 53-week monkey study. The no-effect dose for neurohistopathology in monkeys (0.3 mg/dose) is approximately equivalent to the human dose when calculated on a yearly basis and corrected for the species difference in CSF volume.

8.5 Geriatric Use

Clinical studies of SPINRAZA did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

11 DESCRIPTION

Nusinersen is a modified antisense oligonucleotide, where the 2’-hydroxy groups of the ribofuranosyl rings are replaced with 2’-O-2-methoxyethyl groups and the phosphate linkages are replaced with phosphorothioate linkages. Nusinersen binds to a specific sequence in the intron downstream of exon 7 of the SMN2 transcript. The structural formula is:

10

SPINRAZA is supplied as a sterile, preservative-free, colorless solution for intrathecal use in a single-dose glass vial. Each 1 mL solution contains 2.4 mg of nusinersen (equivalent to 2.53 mg of nusinersen sodium salt). Each 1 mL also contains calcium chloride dihydrate (0.21 mg) USP, magnesium chloride hexahydrate (0.16 mg) USP, potassium chloride (0.22 mg) USP, sodium chloride (8.77 mg) USP, sodium phosphate dibasic anhydrous (0.10 mg) USP, sodium phosphate monobasic dihydrate (0.05 mg) USP, and Water for Injection USP. The product may contain hydrochloric acid or sodium hydroxide to adjust pH. The pH is ~7.2.

The molecular formula of SPINRAZA is C234H323N61O128P17S17Na17 and the molecular weight is 7501.0 daltons.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

SPINRAZA is an antisense oligonucleotide (ASO) designed to treat SMA caused by mutations in chromosome 5q that lead to SMN protein deficiency. Using in vitro assays and studies in transgenic animal models of SMA, SPINRAZA was shown to increase exon 7 inclusion in SMN2 messenger ribonucleic acid (mRNA) transcripts and production of full-length SMN protein.

12.2 Pharmacodynamics

Autopsy samples from patients (n=3) had higher levels of SMN2 messenger ribonucleic acid (mRNA) containing exon 7 in the thoracic spinal cord compared to untreated SMA infants.

Cardiac Electrophysiology

11

Across the sham-controlled studies in 247 patients with spinal muscular atrophy who received either SPINRAZA or sham-control, QTcF values >500 ms and change from baseline values >60 ms were observed in 4 (2.4%) patients receiving SPINRAZA. Compared to the sham-control, there was no increase in the incidence of cardiac adverse reactions associated with delayed ventricular repolarization in patients treated with SPINRAZA.

12.3 Pharmacokinetics

Absorption

Intrathecal injection of SPINRAZA into the cerebrospinal fluid (CSF) allows nusinersen to be distributed from the CSF to the target central nervous system (CNS) tissues. Following intrathecal administration, trough plasma concentrations of nusinersen were relatively low, compared to the trough CSF concentration. Median plasma Tmax values ranged from 1.7 to 6.0 hours. Mean plasma Cmax and AUC values increased approximately dose-proportionally up to a dose of 12 mg. Distribution

Autopsy data from patients (n=3) showed that SPINRAZA administered intrathecally was distributed within the CNS and peripheral tissues, such as skeletal muscle, liver, and kidney.

Elimination

Metabolism

Nusinersen is metabolized via exonuclease (3’- and 5’)-mediated hydrolysis and is not a substrate for, or inhibitor or inducer of CYP450 enzymes.

Excretion

The mean terminal elimination half-life is estimated to be 135 to 177 days in CSF, and 63 to 87 days in plasma. The primary route of elimination is likely by urinary excretion for nusinersen and its chain-shortened metabolites. At 24 hours, only 0.5% of the administered dose was recovered in the urine.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Long-term studies in animals to evaluate the carcinogenic potential of nusinersen have not been performed.

Mutagenesis

Nusinersen demonstrated no evidence of genotoxicity in in vitro (Ames and chromosomal aberration in CHO cells) and in vivo (mouse micronucleus) assays.

Impairment of Fertility

12

When nusinersen (0, 3, 10, or 25 mg/kg) was administered by subcutaneous injection to mice every other day prior to and during mating and continuing in females throughout organogenesis, no adverse effects on male or female fertility were observed.

14 CLINICAL STUDIES

The efficacy of SPINRAZA was demonstrated in two double-blind, sham-procedure controlled clinical trials in symptomatic infantile-onset and later-onset SMA patients (Study 1 and Study 2) and was supported by open-label clinical trials conducted in presymptomatic and symptomatic SMA patients. The overall findings from these trials support the effectiveness of SPINRAZA across the range of SMA patients, and appear to support the early initiation of treatment with SPINRAZA.

14.1 Infantile-Onset SMA

Study 1 was a multicenter, randomized, double-blind, sham-procedure controlled study in 121 symptomatic infants ≤ 7 months of age at the time of first dose, diagnosed with SMA (symptom onset before 6 months of age). Patients were randomized 2:1 to receive either 12 mg SPINRAZA or sham injection as a series of loading doses administered intrathecally followed by maintenance doses administered every 4 months. Patients in this study were deemed most likely to develop Type 1 SMA. A planned interim efficacy analysis was conducted based on patients who died, withdrew, or completed at least 183 days of treatment. Of the 82 patients included in the interim analysis (52 patients in the SPINRAZA-treated group and 30 in the sham-control group), 44% were male, 87% were Caucasian, 2% were Black, and 4% were Asian. Age at first treatment ranged from 30 to 262 days (median 181). Length of treatment ranged from 6 to 442 days (median 261 days). Baseline demographics were balanced between the SPINRAZA and control groups with the exception of age at first treatment (median age 175 vs. 206 days, respectively). The SPINRAZA and control groups were balanced with respect to gestational age, birth weight, disease duration, and SMN2 copy number. Median disease duration was 14 weeks. There was some imbalance in age at symptom onset with 88% of subjects in the SPINRAZA group and 77% in the control group experiencing symptoms within the first 12 weeks of life. The primary endpoint assessed at the time of interim analysis was the proportion of responders: patients with an improvement in motor milestones according to Section 2 of the Hammersmith Infant Neurologic Exam (HINE). This endpoint evaluates seven different areas of motor milestone development, with a maximum score between 2-4 points for each, depending on the milestone, and a total maximum score of 26. A treatment responder was defined as any patient with at least a 2-point increase (or maximal score of 4) in ability to kick (consistent with improvement by at least 2 milestones), or at least a 1-point increase in the motor milestones of head control, rolling, sitting, crawling, standing or walking (consistent with improvement by at least 1 milestone). To be classified as a responder, patients needed to exhibit improvement in more categories of motor milestones than worsening. Of the 82 patients who were eligible for the interim analysis, a statistically significantly greater percentage of patients achieved the

13

definition of a motor milestone responder in the SPINRAZA group (40%) compared to the sham-control group (0%). Results from the final analysis were consistent with those from the interim analysis (Table 3). Fifty-one percent of patients in the SPINRAZA group achieved the definition of a motor milestone responder compared to 0% of patients in the sham-control group. Figure 1 is a descriptive display of the distribution of net change from baseline in the total motor milestone score for Section 2 of the HINE for patients in the final efficacy set who did not die or withdraw from the study. The primary endpoint assessed at the final analysis was time to death or permanent ventilation (≥ 16 hours ventilation/day continuously for > 21 days in the absence of an acute reversible event or tracheostomy). Statistically significant effects on event-free survival and overall survival were observed in patients in the SPINRAZA group compared to those in the sham-control group (Table 4). A 47% reduction in the risk of death or permanent ventilation was observed in the SPINRAZA group (p=0.005) (Figure 2). Median time to death or permanent ventilation was not reached in SPINRAZA group and was 22.6 weeks in the sham-control group. A statistically significant 63% reduction in the risk of death was also observed (p=0.004). At the final analysis, the study also assessed treatment effects on the Children’s Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP-INTEND), which is an evaluation of motor skills in patients with infantile-onset SMA. The CHOP-INTEND results are displayed in Table 3.

Table 3. Motor Milestone Response and CHOP-INTEND Results of the Final Analysis of Patients with Infantile-Onset SMA (Study 1)

Endpoint SPINRAZA-treated Patients (n=73)

Sham-control Patients (n=37)

Motor function Motor milestones1 Proportion achieving pre-defined motor milestone responder criteria (HINE section 2)2,3

37 (51%) P<0.0001

0 (0%)

CHOP-INTEND1 Proportion achieving a 4-point improvement Proportion achieving a 4-point worsening4

52 (71%) p<0.0001

2 (3%)

1 (3%)

17 (46%)1At the final analysis, CHOP-INTEND and motor milestone analyses were conducted using the Efficacy Set (SPINRAZA n=73; Sham-control n=37). 2Assessed at the later of Day 183, Day 302, and Day 394 Study Visit 3According to HINE section 2: ≥2 point increase [or maximal score] in ability to kick, OR ≥1 point increase in the motor milestones of head control, rolling, sitting, crawling, standing or walking, AND improvement in more categories of motor milestones than worsening), defined as a responder for this primary analysis. 4Not statistically controlled for multiple comparisons

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Table 4. Survival Results of Patients with Infantile-Onset SMA (Study 1 ) Endpoint SPINRAZA-treated

Patients (n=80) Sham-control Patients

(n=41) Survival Event-free survival1 Number of patients who died or received permanent ventilation Hazard ratio (95% CI) p-value2

31 (39%)

28 (68%)

0.53 (0.32 -0.89)

p=0.005

Overall survival1 Number of patients who died Hazard Ratio (95% CI) p-value2

13 (16%)

16 (39%)

0.37 (0.18 – 0.77)

p=0.004 1At the final analysis, event-free survival and overall survival were assessed using the Intent to Treat population (ITT SPINRAZA n=80; Sham-control n=41). 2Based on log-rank test stratified by disease duration

Figure 1. Percent of Patients Who Died and Net Change from Baseline in Total Motor Milestone Score (HINE) Among Patients Alive in the Final Efficacy Set of Study 1 *

*For subjects who were alive and ongoing in the study, the change in total motor milestone score was calculated at the later of Day 183, Day 302, or Day 394.

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Figure 2. Event-Free Survival in the Intent to Treat Set

14.2 Later-Onset SMA Study 2 was a multicenter, randomized, double-blind, sham-procedure controlled study in 126 symptomatic children with later-onset SMA (symptom onset after 6 months of age). Patients were randomized 2:1 to either SPINRAZA 12 mg or sham injection as a series of loading doses administered intrathecally followed by maintenance doses administered every 6 months. The median age at screening was 3 years (range 2-9 years), and the median age of onset of clinical signs and symptoms of SMA was 11 months (range 6-20 months). Of the 126 patients included in the study, 47% were male, 75% were Caucasian, 2% were Black, and 18% were Asian. Length of treatment ranged from 324 to 482 days (median 450 days). At baseline, patients had a mean Hammersmith Functional Motor Scale – Expanded (HFMSE) score of 21.6, all had achieved independent sitting, and no patients had achieved independent walking. Patients in this study were deemed most likely to develop Type 2 or 3 SMA. The primary endpoint assessed was the change from baseline score at Month 15 on the HFMSE. The HFMSE evaluates motor function in patients with SMA who have limited ambulation, comprising of 33 scored activities that give objective information on motor ability and clinical progression, such as the ability to sit unassisted, stand, or walk. Each item is scored from 0-2, with a maximum total score of 66. Higher scores indicate better motor function. The primary

16

analysis was conducted in the Intent to Treat (ITT) population, which included all subjects who were randomized and received at least 1 dose of SPINRAZA or at least one sham procedure. At the final analysis, a statistically significant improvement in HFMSE scores from baseline to Month 15 was observed in the SPINRAZA-treated group compared to the sham-control group (Table 5). Table 5: HFMSE Results in Patients with Later-Onset SMA (Study 2) Endpoint SPINRAZA-treated

Patients (n=84) Sham-control Patients

(n=42) HFMSE score Change from baseline in total HFMSE score at 15 months1,2,3 Proportion of patients who achieved at least a 3-point improvement from baseline to Month 151

3.9 (95% CI: 3.0, 4.9) p=0.0000001

56.8% (95% CI: 45.6,

68.1) p=0.00064

-1.0 (95% CI: -2.5, 0.5)

26.3% (95% CI: 12.4, 40.2)

1Assessed using the Intent to Treat population who received at least one dose of SPINRAZA or at least one sham procedure (SPINRAZA n=84; Sham-control n=42); data for patients without a Month 15 visit were imputed using the multiple imputation method 2Least squares mean 3Negative value indicates worsening, positive value indicates improvement. 4Based on logistic regression with treatment effect and adjustment for each subject's age at screening and HFMSE score at baseline

17

Figure 3. Mean Change from Baseline in HFMSE Score Over Time in the Intent to Treat Set1, 2(Study 2)

1Data for patients without a Month 15 visit were imputed using the multiple imputation method 2Error bars denote +/- standard error 14.3 Presymptomatic SMA The results of the sham-controlled trial in infantile-onset and later-onset SMA patients were supported by an open-label uncontrolled trial conducted in presymptomatic SMA patients, who ranged in age from 3 days to 42 days at the time of first dose. Patients received 12 mg SPINRAZA as a series of loading doses administered intrathecally followed by maintenance doses administered every 4 months. Some patients receiving SPINRAZA before the onset of SMA symptoms survived without requiring permanent ventilation beyond what would be expected based on their SMN2 copy number, and some patients also achieved age-appropriate growth and developmental motor milestones such as the ability to sit unassisted, stand, or walk.

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16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

SPINRAZA injection is a sterile, clear and colorless solution supplied as a 12 mg/5 mL (2.4 mg/mL) solution in a single-dose glass vial free of preservatives. The NDC is 64406-058-01.

16.2 Storage and Handling

Store in a refrigerator between 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze.

SPINRAZA should be protected from light and kept in the original carton until time of use. If no refrigeration is available, SPINRAZA may be stored in its original carton, protected from light at or below 30oC (86oF) for up to 14 days.

Prior to administration, unopened vials of SPINRAZA can be removed from and returned to the refrigerator, if necessary. If removed from the original carton, the total combined time out of refrigeration should not exceed 30 hours at a temperature that does not exceed 25oC (77oF).

17 PATIENT COUNSELING INFORMATION

Thrombocytopenia and Coagulation Abnormalities Inform patients and caregivers that SPINRAZA could increase the risk of bleeding. Inform patients and caregivers of the importance of obtaining blood laboratory testing at baseline and prior to each dose to monitor for signs of increased potential for bleeding. Instruct patients and caregivers to seek medical attention if unexpected bleeding occurs [see Warnings and Precautions (5.1)]. Renal Toxicity Inform patients and caregivers that SPINRAZA could cause renal toxicity. Inform patients and caregivers of the importance of obtaining urine testing at baseline and prior to each dose to monitor for signs of potential renal toxicity [see Warnings and Precautions (5.2)].

49655-07

Manufactured for:

Biogen

Cambridge, MA 02142

SPINRAZA is a registered trademark of Biogen.

© Biogen 2016-2019

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