MYOBLOC is available in three vial sizes for dosing flexibility
The MYOBLOC Reimbursement Services team provides information and assistance as requested by the Healthcare Provider
Enroll in MYOBLOC Reimbursement Services by completing the reimbursement support program enrollment form or signing up using the Circle of Care Provider Portal.
To provide administrative assistance in your practice, the following billing and coding tools are available:
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-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.
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
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.
MYOBLOC is available at no charge to eligible patients who are approved for the Patient Assistance Program.
For patients who are approved for the Patient Assistance Program:
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.
MYOBLOC® (rimabotulinumtoxinB) injection is indicated for:
WARNING: DISTANT SPREAD OF TOXIN EFFECT
See full prescribing information for complete boxed WARNING.
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 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, particularly in those patients who have an underlying condition that would predispose them to these symptoms.
MYOBLOC is contraindicated in patients with:
Lack of Interchangeability Between Botulinum Toxin Products
The potency units of MYOBLOC are specific to the preparation and biological activity assay method utilized. Due to differences in the aspects of this assay such as the vehicle, dilution scheme, and laboratory protocols for various potency assays, potency units 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.
Serious hypersensitivity reactions have been reported with botulinum toxin products. Angioedema, urticaria, and rash have occurred with MYOBLOC treatment. Hypersensitivity reactions can also include anaphylaxis, serum sickness, soft tissue edema, and dyspnea. If serious and/or immediate hypersensitivity reactions occur, discontinue further injection of MYOBLOC and institute appropriate medical therapy immediately. The use of MYOBLOC in patients with a known hypersensitivity to any botulinum neurotoxin or to any of the excipients (human albumin, sucrose), could lead to a life-threatening allergic reaction.
Dysphagia and Breathing Difficulties
Treatment with MYOBLOC and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with pre-existing 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.
Pre-Existing Neuromuscular Disorders
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.
Human Albumin and Transmission of Viral Diseases
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 and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would be considered extremely remote. No cases of transmission of viral diseases, CJD, or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products.
Cervical Dystonia: dry mouth, dysphagia, injection site pain, headache
Sialorrhea: dry mouth, dysphagia
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. Use of anticholinergic drugs after administration of MYOBLOC may potentiate systemic anticholinergic effects. The effect of administering different botulinum toxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin. Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of MYOBLOC.
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.