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ORDERING & SUPPORT


MYOBLOC is available in three vial sizes for dosing flexibility

MYOBLOC is ready to use and requires no mixing.

Storage

  • MYOBLOC must be refrigerated (2°-8°C or 36°-46°F)
  • Do not freeze or shake (pH=5.6)
  • Protect from light
To order MYOBLOC, call 1-888-461-2255, option 1.
To order MYOBLOC, call 1-888-461-2255, option 1.
All orders are shipped in a specially-designed box packaged to maintain the required temperature between 36° and 46° F (2–8° C) during shipment.

MYOBLOC REIMBURSEMENT SERVICES


The MYOBLOC Reimbursement Services team provides information and assistance as requested by the Healthcare Provider

GENERAL BILLING AND CODING ASSISTANCE
PATIENT-SPECIFIC INSURANCE BENEFIT INVESTIGATIONS
Provide a summary of benefits obtained from the insurance company to the Healthcare Provider
Benefits investigated for medical coverage and, where permitted under policy, specialty pharmacy coverage
  • Specialty Pharmacy form is provided to the Healthcare Provider
Prior Authorization assistance
  • Identification of payor requirements for approval
  • Obtaining and providing the payors required form to the Healthcare Provider
GENERAL ASSISTANCE WITH CLAIMS AND APPEALS OF DENIED CLAIMS
General coding
Protocols for requesting appeals and/or review of claims
Answering questions from the healthcare provider’s office concerning claim denial

BILLING & CODING TOOLS


To provide administrative assistance in your practice, the following billing and coding tools are available:

J-code for MYOBLOC
CODE
DESCRIPTION
J‍0587

JW Modifier - Required to be reported on a Medicare Part B drug claim for discarded drugs and biologicals. Providers must also document the amount of discarded drugs or biologicals in the Medicare beneficiaries' medical records.

For J0587, a billing unit is per 100 Units of MYOBLOC. For example, injecting 2,500 Units into a patient would allow for 25 billable Units.

I‍CD-10-CM code for spasmodic torticollis (CD)*
G24.3
 
CPT codes for chemodenervation of muscle(s), cervical spinal muscles(s) (e.g., for spasmodic torticollis)
6‍46‍16
50 Modifier - Bilateral Procedure
EMG codes from chemodenervation
9‍58‍73
Electrical stimulation for guidance in conjunction with chemodenervation
9‍58‍74
Needle electromyography for guidance in conjunction with chemodenervation
7‍69‍42
Ultrasonic guidance for needle placement (e.g., biopsy, aspiration, injection, localization device), imaging supervision and interpretation
National Drug Codes (NDCs)
Vial Size
NDC Numbers§
2,500 Units/0.5 mL
1‍045‍4-710-10
5,000 Units/1 mL
1‍0454‍-711-10
10,000 Units/2 mL
1‍045‍4-712-10


* ICD-CM codes are based on the World Health Organization (WHO) International Classification of Diseases, 10th edition. Solstice Neurosciences, LLC assumes no liability for information contained herein. Solstice claims no ownership or other interest in the ICD-CM codes. ICD-CM codes are provided herein for reference only. Only a patient’s healthcare provider may determine the appropriate ICD-CM code.

CPT® codes are copyrighted property of the American Medical Association (AMA). Solstice assumes no liability for any of the information contained herein. Solstice claims no ownership or other interest in the CPT codes. CPT codes are provided herein for reference only and are not intended to convey any endorsement or sponsorship by, or affiliation with, the AMA.

CPT code 64616 is the usual CPT code for administration of MYOBLOC for the treatment of spasmodic torticollis (otherwise known as cervical dystonia). Other administration codes may be appropriate as determined by the patient’s healthcare provider.

§ Please note that for billing purposes, some payers may require an 11-digit code based on the NDC number. Therefore, a zero must be entered into the 6th position (e.g., “10454-0710-10”). This is consistent with the Red Book and First DataBank listings.

MYOBLOC PATIENT PROGRAMS


For eligible patients who need financial assistance in obtaining MYOBLOC treatment, we offer the following patient programs:

The MYOBLOC Copay Program assists eligible patients with cervical dystonia with their out-of-pocket expenses associated with MYOBLOC and the related administration expenses. With no limit per injection, eligible patients may receive up to $4,000 per year of assistance with permitted out-of-pocket expenses.1

Patients who are 18 years or older, diagnosed with cervical dystonia (G24.3), a legal US resident, who have commercial insurance coverage according to the terms and conditions of the program and are NOT enrolled in a government insurance plan (e.g. Medicare, Medicaid, TRICARE, and other federal or state-funded programs).2

HCP staff may enroll patients by using the MYOBLOC Copay Portal or calling 1-877-268-7697. Or patients may enroll themselves by calling 1-877-268-7697 — No enrollment forms needed.

Once eligible for participation, the patient’s eligible out-of-pocket expenses may be paid directly to the site of care (administering office or pharmacy) on the patient’s behalf, or to the patient as a reimbursement for out-of-pocket expenses they paid to the site of care.

Irrespective of who will receive the copay payment, the site of care must first file a claim for MYOBLOC and the related injection-administration expenses with the patient’s private insurance carrier(s). An Explanation of Benefits that shows payment for MYOBLOC and the related injection expenses is required with supporting evidence to establish out-of-pocket expenses before any such reimbursement is authorized by the MYOBLOC Copay Program [See Reference 1 for Michigan, Rhode Island, and Minnesota residents].

Upon approval into the program, eligible costs for the patient’s MYOBLOC injections may be submitted for payment. The program administrator will verify that the costs are eligible for payment. Payment for eligible costs will be issued to the site of care via a virtual Mastercard number within two business days of the receipt of information validating eligible out-of-pocket expenses.

If the site of care requires a check reimbursement, that check will be issued and mailed within 3-4 weeks. Any pharmacy using the Copay Program may use the patient’s card ID, Rx and BIN to process and receive payment on claims.

Terms and Conditions for Healthcare Providers

1. This offer is valid for commercially-insured patients only and is good for use only with a MYOBLOC prescription at the time the prescription is filled or after the product is administered to the patient. 2. Depending on insurance coverage, eligible insured patients may pay no more than zero dollars ($0) for MYOBLOC and the administrative services associated with MYOBLOC, up to a maximum savings limit of four thousand dollars ($4,000) per year. Patient out-of-pocket expense may vary. 3. This offer is not valid for patients enrolled in Medicare, Medicaid, or other federal or state healthcare programs, or private indemnity or HMO insurance plans that reimburse you for the entire cost of your prescription drugs. Patients may not use this Program if they are Medicare-eligible and enrolled in an employer-sponsored health plan or medical or prescription drug benefit program for retirees. 4. The offer is valid for one (1) year. 5. US WorldMeds reserves the right to rescind, revoke, or amend this offer without notice. 6. Offer good only in the USA, including Puerto Rico, at participating pharmacies or healthcare providers. 7. Void if prohibited by law, taxed, or restricted. 8. Residents of Michigan, Rhode Island, and Minnesota are not eligible for assistance with payment for injection or injection guidance-related costs, but may receive assistance with MYOBLOC. 9. This Program is not transferable. The selling, purchasing, trading, or counterfeiting of this Program is prohibited by law. 10. This Program is not insurance. 11. By redeeming this assistance, you represent that, to the best of your knowledge, the patient is eligible to participate in the Program and that you understand and agree to comply with the terms and conditions of this offer.

*Patients are free, at any time, to switch healthcare providers, practitioners, pharmacies, commercial insurers, or suppliers without affecting continued eligibility for assistance. If patients begin receiving benefits from a government program, they would become ineligible for the Co-Pay Assistance Program for MYOBLOC.

Submitting an application for assistance does not guarantee funding will be available. If financial assistance is awarded, it will be provided on an annual basis. Applicants must reapply for assistance each year. Funding in any subsequent year(s) or timeframes is not guaranteed. The Co-Pay Assistance Program for MYOBLOC may be modified or discontinued at any time.

NOTE: Reimbursement services are available only for those patients being treated with MYOBLOC for a therapeutic condition for which there is a reasonable expectation of reimbursement from a third-party payer. Physicians are responsible for identifying the clinical indication and documenting medical necessity for use of MYOBLOC. Questions regarding the clinical use of MYOBLOC should be directed to 1-888-461-2255, Option 2.

References:

  1. Including MYOBLOC drug co-insurance [J0587], injection co-insurance [CPT Code: 64616,] and injection guidance (such as EMG) co-insurance [CPT Codes: 95873, 95874]. Patients residing in Michigan, Rhode Island, and Minnesota are not eligible for assistance with payment for injection or injection guidance-related costs, but may receive assistance with MYOBLOC.
  2. Government insured patients, such as Medicare, Medicaid, TRICARE®, Department of Veterans Affairs, and other federal or state funded programs are not eligible for participation in the Co-Pay Assistance Program for MYOBLOC. Massachusetts residents are not eligible to participate in the Co-Pay Assistance Program for MYOBLOC. Patients residing in Michigan, Rhode Island, and Minnesota are not eligible for assistance with payment for injection or injection guidance-related costs, but may receive assistance with MYOBLOC.

MYOBLOC is available at no charge to eligible patients who are approved for the Patient Assistance Program.

Eligibility Criteria:

  • Patients for whom MYOBLOC is prescribed by a licensed physician to treat cervical dystonia
  • Patients who have no health insurance benefits for MYOBLOC
    • Insured - No benefits
    • Uninsured
  • Patient cannot otherwise afford MYOBLOC therapy
  • Patient is a legal United States resident
  • Patient is injected with J-Code J0587 accompanied with ICD-10 code G24.3

For patients who are approved for the Patient Assistance Program:

  • MYOBLOC is provided at no charge
  • MYOBLOC is shipped directly to the healthcare provider marked for patient use
  • Qualified patients are eligible to receive MYOBLOC injections for two (2) dates of services provided that they do not subsequently gain health insurance benefits
    • Patient may re-apply for additional dates of service
  • Patient is responsible for any charges related to physician services

Solstice Neurosciences, LLC (“Solstice Neurosciences”), a wholly-owned subsidiary of US WorldMeds, LLC, sets the criteria for the Patient Assistance Program. Acceptance into the program at any time is not a guarantee that patients are entitled to receive assistance indefinitely.

Solstice Neurosciences reserves the right at any time, and without notice, to modify or discontinue any or all of the aspects of the Program; or to terminate assistance under the Program at any time.


INDICATION

MYOBLOC® (rimabotulinumtoxinB) Injection is indicated for the treatment of adults with cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia.

IMPORTANT SAFETY INFORMATION FOR MYOBLOC

WARNING: DISTANT SPREAD OF TOXIN EFFECT

Postmarketing reports indicate that the effects of MYOBLOC and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including spasticity in children and adults, and in approved indications, cases of spread of effect have occurred at doses comparable to those used to treat cervical dystonia and at lower doses [see Warnings and Precautions].

MYOBLOC is contraindicated in patients with a known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.

MYOBLOC is contraindicated for use in patients with infection at the proposed injection site(s).

The potency Units of MYOBLOC are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of MYOBLOC cannot be compared to or converted into units of any other botulinum toxin products assessed with any other specific assay method.

Treatment with MYOBLOC and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with preexisting swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or swallowing. When distant effects occur, additional respiratory muscles may be involved.

Deaths as a complication of severe dysphagia have been reported after treatment with botulinum toxin. Dysphagia may persist for several months and require use of a feeding tube to maintain adequate nutrition and hydration. Aspiration may result from severe dysphagia and is a particular risk when treating patients in whom swallowing or respiratory function is already compromised.

Treatment of cervical dystonia with botulinum toxins may weaken neck muscles that serve as accessory muscles of ventilation. This may result in a critical loss of breathing capacity in patients with respiratory disorders who may have become dependent upon these accessory muscles. There have been postmarketing reports of serious breathing difficulties, including respiratory failure, in cervical dystonia patients. Patients treated with botulinum toxin may require immediate medical attention should they develop problems with swallowing, speech or respiratory disorders. These reactions can occur within hours to weeks after injection with botulinum toxin.

Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) should be monitored particularly closely when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including severe dysphagia and respiratory compromise from typical doses of MYOBLOC.

This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for albumin.

Only 9 subjects without a prior history of tolerating injections of type A botulinum toxin have been studied. Treatment of botulinum toxin naïve patients should be initiated at lower doses of MYOBLOC.

Co-administration of MYOBLOC and aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated.

The effect of administering different botulinum neurotoxin serotypes at the same time or within less than 4 months of each other is unknown. However, neuromuscular paralysis may be potentiated by co-administration or overlapping administration of different botulinum toxin serotypes.

It is not known whether MYOBLOC can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. MYOBLOC should be given to a pregnant woman only if clearly needed.

The most commonly reported adverse events associated with MYOBLOC treatment in all studies were dry mouth, dysphagia, dyspepsia, and injection site pain. Dry mouth and dysphagia were the adverse reactions most frequently resulting in discontinuation of treatment. There was an increased incidence of dysphagia with increased dose in the sternocleidomastoid muscle. The incidence of dry mouth showed some dose-related increase with doses injected into the splenius capitis, trapezius and sternocleidomastoid muscles.

To report SUSPECTED ADVERSE REACTIONS or product complaints, contact US WorldMeds at 1-888-461-2255, Option 2. You may also report SUSPECTED ADVERSE REACTIONS to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see the full Prescribing Information, including Boxed WARNING and Medication Guide.