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- Who should be registered for Document For Safety?
As of April 2012, any provider who may prescribe the following medications to the NC Medicaid and Health Choice populations should become a registered provider at Document For Safety:
- brand name drug when patient experienced an adverse reaction to the generic,
- Synagis, or
- an antipsychotic to a patient 17 years of age and younger.
- If I am affiliated with multiple organizations or practice locations within one organization, do I have to register separately for each one?
No, registration occurs at the provider level. The provider’s “My Patients” tab within the applications will include all patients who currently have an authorization made by that provider regardless of the practice location where the provider usually sees that patient.
- Is this a secure system for patient information to be entered?
Yes. This is a secure website for documentation of patient specific information. Additionally, the Document For Safety applications contain an automatic time out after 30 minutes of inactivity. If this occurs, there will be a notification that allows for easy re-entry/login.
- How do I register as a provider?
Providers must register for secure access to any of the web-based programs available at Document For Safety. This simple process may be performed online by registering via the My Patients tab on this website.
- What confirmation will I receive upon registration?
The registration process includes an automated pathway that will allow many providers to have their account information activated at the time of the initial registration request. For provider registration requests that have to be manually approved, a communication confirming the registration request will be sent within 5 business days.
- Is there a number to call for technical support?
Technical support is available by calling 855-272-6576. Technical support can assist with provider registration, user name and password issues, patient not found/eligibility messages, and other concerns regarding registry functions.
- What should I do if I am unable to find my patient using the search feature?
Providers who cannot locate a patient using the patient search function should call provider support at 855-272-6576 for assistance.
- Who can I contact to make a suggestion to improve the programs available through Document For Safety?
We welcome your feedback regarding the registry process or ways to make the process work better for providers and patient care. Please submit your feedback electronically here.
- How long has the A+KIDS program been in place?
A+KIDS was originally launched in April 2011 and was most recently expanded in February 2012 to include all NC Medicaid and Health Choice recipients through age 17.
- Do I have to use the web-based registry to enter the safety information?
There is a fax option available here. However, the fax form will require follow up documentation after 3 months, while entry via the registry will require follow up documentation at either 6 or 12 months. Also, entering the information via the web-based registry provides the additional benefit of real time communication to the pharmacy that safety documentation has been completed.
- Why do we have to complete this registry information?
The use of antipsychotic medications by children is an issue confronting parents, other caregivers, healthcare professionals and related organized healthcare agencies across the United States. The use of antipsychotic medications in children and adolescent populations is not as well studied as in adults. It is recognized that many antipsychotic medications do not have Food and Drug Administration (FDA) approved labeling for use in children. Further, children and adolescents appear to be at similar or greater risk than adults for a variety of significant side effects related to the use of antipsychotic medications. This registry is intended for providers to document the use of antipsychotic therapy in the child and adolescent Medicaid population, and by doing so, encourages the use of appropriate baseline and follow-up monitoring parameters to facilitate the safe and effective use of these agents in this population.
- Who put together the registry questions and monitoring parameters?
An advisory panel consisting of child and adolescent psychiatry thought leaders from across North Carolina served to put together the registry and the guidelines for use.
- I do not know how to do a movement disorder assessment. Are there training materials to assist me?
There are training resources on this website to support providers in performing a basic movement disorder assessment.
- What if I do not have all of the answers to the patient registry questions and monitoring parameters when I put in the documentation?
The A+KIDS application provides a “Save for Later” option where partially entered documentation may be saved in a patient’s profile for up to 30 days; this allows for the provider to return to the application and enter the remaining information at a later time. It should be noted that partial saves will not create an authorization or reauthorization until they have been completed. Additionally, due to feedback received from providers, an upcoming version of the registry will allow providers to enter lab data at any time (separate from individual authorizations or reauthorizations of antipsychotic medications).
- Once the safety documentation is submitted, how quickly can the patient receive his/her antipsychotic prescription from the pharmacy?
Using the web-based registry to submit documentation provides the benefit of real time communication of the authorization; a claim should be able to be processed successfully by the pharmacy within minutes of the provider submitting the web-based safety documentation. Submission of fax-based safety documentation requires a 24-48 hour period of time to pass before the pharmacy will be able to successfully process the claim.
- How will I be alerted to upcoming safety documentation that is due?
A weekly reminder will be sent to the email account that the provider used to register for the application. The email will contain a link that takes providers directly to the login page of the Document For Safety website and will also indicate the number of patients with safety documentation due within the next 3 months. The email alerts are an optional feature; if a provider chooses not to receive them, he/she can opt out of them within the Provider Profile (available through the pull down menu in the upper right hand corner of the site after login).
- What should I do if I am receiving reminders about upcoming safety documentation due for patients whom I no longer see?
For patients no longer under a provider’s care who populate the My Patients page and trigger email reminders for upcoming safety documentation, providers can use the Hide button available on both the My Patients and Home tabs. This feature will not remove any information that has been previously entered by the provider for the patient; it only removes the patient from the provider’s active list and email reminders. The provider is able to access the patient again at any time via the Patient Lookup feature as long as the patient is currently enrolled with Medicaid.
- Will my patient be able to have his/her prescription filled if safety documentation is not yet in place?
Two pharmacy overrides per recipient per year are available for occurrences where the prescriber has not provided safety documentation. If a third override is attempted, the pharmacy will receive a message that the override limit has been exceeded. The alert indicates the prescriber must provide the requested documentation for the recipient in order for successful claims processing to result.
- Is there an online authorization for adult antipsychotics like there is for antipsychotics for children through the A+KIDS program?
No, there is not a web-based authorization process available for adult antipsychotics at this time.
- Are there any indications or diagnoses that warrant exemption from this policy?
Per the NC Medicaid policy Off Label Antipsychotic Safety Monitoring in Recipients 18 and Older, patients with the following diagnoses are exempt from the prior authorization requirement for antipsychotics:
- Schizophrenia
- Schizophreniform disorder
- Schizoaffective disorder
- Delusional disorder
- Brief psychotic disorder
- Shared psychotic disorder
- Psychotic disorder NOS
- Bipolar disorder
- Major depressive disorder with psychotic features
- Treatment resistant depression (antipsychotic use for TRD is adjunctive only)
- Tourette syndrome
- Other psychosis
The exemption ensures recipients with these diagnoses are able to obtain antipsychotic medications without documentation.
- How should the prescriber authorize an exemption for one of the above listed diagnoses?
When any of the above diagnoses are present, the prescriber should write on the face of each new and renewal prescription, in his/her own handwriting, “Meets PA Criteria” to authorize the exemption. “Meets PA Criteria” may also be entered in the comment block on e-prescriptions. The pharmacist is authorized to override the documentation requirement when “Meets PA Criteria” is written. If an exempted diagnosis is found in the recipient’s most recent 24 months of Medicaid claims data, an atypical claim can process successfully without any action at all by the prescriber.
- What is the duration of the exemption that is authorized by the use of “Meets PA Criteria”?
The “Meets PA Criteria” exemption is effective for the duration of the prescription on which it is written.
- How does a provider obtain prior approval for a non-exempt off label indication such as sleep or anxiety?
When documentation is required, the information may be submitted by faxing a completed Adult Safety with Antipsychotic Prescribing (ASAP) form to ACS at 866-246-8507 or by calling ACS with the information at 866-246-8505. The form can be found here.
- What information is needed to gain prior approval via fax or phone?
The information requested includes:
- Drug and total daily dosage
- Primary psychiatric diagnosis
- Primary target symptoms
- Whether the recipient has been informed regarding the potential metabolic and neurologic adverse effects with these agents.
- What is the duration of the authorization that is obtained via fax or phone?
Fax or phone-based authorizations have a 12 month approval associated with them.
- What will happen to my patient if documentation is not in place or there is not an exempt diagnosis?
Two pharmacy overrides per recipient per year are available for occurrences where the prescriber has not provided documentation or an exempted diagnosis does not exist. If a third override is attempted, the pharmacy will receive a message that the override limit has been exceeded. The alert indicates the prescriber must provide the requested documentation for the recipient in order for successful claims processing to result.
- Are there any brand name drugs that are exempt from the requirements of this policy?
Brand name medications for the treatment of seizures or designated as Narrow Therapeutic Index (NTI) drugs by the NC Board of Pharmacy are exempt from the requirements of this policy. The current list of NTI medications can be found through the following link: http://www.ncbop.org/faqs/Pharmacist/faq_NTIDrugs.htm
- How should a request for a brand name drug be submitted?
The web-based BRANDS application allows providers to submit a request for a brand name drug when an adverse event occurred related to a generic equivalent. After selecting the patient and the name of the brand name drug being requested, the provider will be asked to submit information about the adverse event that occurred with a generic equivalent similar to the information requested by the FDA on the MedWatch form. Adverse event reports may be submitted to the FDA in addition to NC Medicaid.
- Once a brand name drug is approved, how long does the authorization last?
The authorization does not have an end date associated with it.
- If the provider changes the dose of the authorized brand medication, is a new request needed?
No, an existing authorization should cover all available strengths and dosage forms of the brand medication authorized.
- When does coverage of Synagis take effect?
The coverage period for Synagis is reviewed each year. Indicators predicting RSV prevalence in communities across the state are considered when deciding the coverage period. The start date and end date is provided in the General Medicaid Bulletin and Pharmacy Newsletter communication about coverage of Synagis each season. The bulletin article will be posted on the Resources page. POS processing of Synagis claims begins at least three business days prior to the coverage start date to allow pharmacies to provide the medication by the start date.
- When can providers gain access to the electronic system?
The system always allows access for provider registration requests. Access to submit prior approval request for individual patients begins in early October.
- How do I register as a provider?
Providers must register for secure access to the www.documentforsafety.org website. Go to www.documentforsafety.org and click on the register here link. Providers with a user ID and email address for the A+KIDS (Antipsychotics – Keeping It Documented for Safety) Registry or BRANDS Program may use the same login and password to access the Synagis Program.
- What confirmation will I receive after submitting my registration?
Within five business days of submitting your registration, you will receive a communication containing your user ID (email address) and temporary password which can be used to log into the system. If more immediate access to the system is needed, please contact technical support at 855-272-6576 (local: 919-657-8843).
- I have a new patient to my practice that already has prior approval for Synagis for the season. What should I do?
A new PA request for coverage is not needed because coverage is already approved. If the new provider wants to continue Synagis prophylaxis, log onto the system, search for the patient, and request the next dose. If authorization for the next dose was obtained already by the previous provider, communication between the practices and/or pharmacy may be necessary to ensure the medication is available for administration.
- Do I have to use the electronic registry to request prior approval for Synagis?
The method to request prior approval for Synagis is electronic using the www.documentforsafety.org website. Fax requests are not processed. A fax form will not be available on the DMA website. Forms from past seasons are expired and will not be processed.
- My practice does not have internet access. What should I do?
Contact the Medicaid Pharmacy Program at (919) 855-4300.
- Is there a number to call for technical support?
Technical support is available from 8am to 5pm by calling 855-272-6576 (local: 919-657-8843). Technical support can assist with provider registration, user name and password issues, patient searches, and other registry functions.
- What should I do if I am unable to find my patient using the search feature?
Providers who cannot locate a patient using the patient search function should call technical support at 855-272-6576 (local: 919-657-8843) for assistance.
- Who can I contact to make a suggestion to improve the electronic PA process?
We welcome your feedback regarding the registry process or ways to make the process work better for providers and patient care. Please submit your feedback electronically here.