The Department defines specialty drugs as typically high cost drugs, used to treat acute and chronic conditions. They often require special handling, and can be self-administered in the home or administered by a health care provider in the home or practitioner’s office. Specialty drugs are often associated with complex drug regimens and require patient education, monitoring and clinical support. Many times these drugs are only available through specialty pharmacy networks.
The behavioral health benefit is transitioning from fee-for-service into the Medicaid Managed Care benefit in stages. More information about this transition can be found here: Behavioral Health Transition to Managed Care
A formulary is a list of drugs that are preferred by a health plan. Health plans usually only cover drugs (brand and generic) that are on this "preferred" list. Plans use formularies because there are often many safe and effective drugs used to treat the same conditions and some cost more than others. The development of a formulary ensures that health plan members have access to effective, safe and cost effective drugs.
Generic drugs are copies of brand name drugs and have the same active ingredients. The Food and Drug Administration (FDA) requires that generic drugs be as safe and effective as brand-name drugs. A generic drug will look different than the equivalent brand name drug and may have different inactive ingredients.
Drugs that are not listed on a health plans formulary may be either non-formulary or covered as a medical benefit. Non formulary drugs may be covered if the provider or member requests coverage. The process for submitting a request for covering a drug that is not on the health plan’s formulary or determining if a drug is covered as a medical benefit can be found by contacting the health plan or accessing their web site.
In most health plans, the formulary is developed by a pharmacy and therapeutics committee made up of pharmacists and physicians from various medical specialties. The committee reviews new and existing medications and selects drugs to be in the health plan's formulary based on safety and how well they work. The committee then selects the most cost-effective drugs in each drug class. A drug class is a group of drugs that treat a specific health condition or that work in a certain way.
There are some types of drugs that are not covered. Some examples are drugs used for hair loss, sexual dysfunction or for cosmetic purposes. Even though these drugs are not usually covered, all health plans have processes in place to review requests for these drugs. The process for submitting a request for a drug that is not covered can be found by contacting the health plan or accessing their web site
Yes, health plans may limit quantity and dosage frequency consistent with how the FDA has approved the use of the drug. Some quantity limits will be listed in the Quantity Limit field on the individual drug look up or in the covered drug drop down box under the drug look-up lists. In some instances, for chronic medications, the quantity limit field will say none. In this case the quantity limit will be consistent with the FDA daily dosing recommendation and plan monthly limits.
Step therapy is when the health plan requires that one or more lower cost drugs in the same drug class or in a proven clinical alternative drug class be tried before they will cover the requested drug.
When a drug requires prior authorization it means that the health care provider must ask for approval before the drug can be covered. Drugs may require prior authorization because there is an equally effective low cost alternative, there are safety concerns and/or a potential for inappropriate use. The process for submitting prior authorization requests varies by plan and may be done by phone, fax or electronically. In all cases, providers will need to provide their rationale for covering the drug. The process for submitting a PA request can be found by contacting the health plan or accessing their web site.
The length of the PA process can vary depending on whether the request is fast tracked or standard and if the health plan receives all the required information to evaluate. See the health plan’s website or member handbook for more information PA process time frames.
Call centers take calls from providers and members who have questions regarding benefit information or limitations. A customer service representative should be able to assist in providing formulary alternatives if the drug you are calling about requires PA. If a customer service representative is unable to assist you, then you can ask to speak to a supervisor or a health care professional such as a pharmacist or a physician. You can find the toll free number for your health plan’s call center at: http://pbic.nysdoh.suny.edu
The way health plans handle dose changes, for those drugs in which PA was previously obtained and not expired, varies based on each health plans system capabilities. If a new PA is required, submission of the standardized PA form is helpful, as it addresses issues relating to dose titration and dose adjustments.
Health plans do consider care transitions and life situations in their PA process on a case by case basis. There is a section on the standard PA form which asks for this type of information (homelessness, poly-substance abuse, transition from hospital etc.) and it should be provided with the PA request.
A notice of action is a letter sent to both the provider and member which explains why a drug is not covered or is not medically necessary. The notice may also be called an Initial Adverse Determination. The notice explains what rights the member has to appeal the health plan’s decision. The notice also gives information on the member’s right to a State fair hearing and, if the denial was based on medical necessity, the member’s right to an independent external appeal.
An appeal is a process in which the member may ask to have the plan review a denied request again. The member will have at least 60 business days to file an appeal from the date of the notice of action. The appeal may be expedited if a delay will cause harm to the member’s health. The health plan must make its decision within a specified time. See the health plan’s website or member handbook for more information about the health plan’s appeal process.
A provider may appeal a health plan’s decision on behalf of a member by following the health plan’s process for internal appeals. Go to the health plan’s website or provider manual for information on the Provider appeals process. To find out more information about provider rights please visit the New York State Department of Financial Services website at: http://www.dfs.ny.gov/insurance/hprovrght.htm
A reconsideration is a peer-to-peer (provider-to-provider) discussion between the requesting provider and the health plan’s reviewer. This option is available for providers, if the health plan did not discuss the request with a provider before issuing a medical necessity denial. If the health plan still does not approve the medication, a new notice of action is issued. A reconsideration does not interfere with an member’s right to file an appeal.
An independent external appeal is a review of the drug request by health professionals that do not work for the health plan or the State. When a health plan denies a medication as not medically necessary, the member has a right to external appeal. A provider may act as the member’s designee. A provider also has their own right to an external appeal in certain situations. For more information about when an external appeal may be filed, see the health plan’s website, the member handbook, or the New York State Department of Financial Services website at: http://www.dfs.ny.gov/insurance/extapp/extappqa.htm
A fair hearing is a review of the member’s request for coverage by an Administrative Law Judge. Medicaid managed care, and HIV Special Needs Plan members have a right to a fair hearing from New York State when the health plan decides to deny, reduce or end their health care or does not make a decision in a reasonable amount of time. The decision the member receives from the fair hearing officer will be final. If a member asks for an external appeal and a fair hearing, the decision of the fair hearing officer will be the one that counts. For more information about member rights and how to ask for a fair hearing, see the health plan’s website, the member handbook, or the New York State Office of Administrative Hearings website at: http://otda.ny.gov/oah/
The Medicaid Managed Care Model Contract can be found here: : https://www.health.ny.gov/health_care/managed_care/docs/medicaid_managed_care_fhp_hiv-snp_model_contract.pdf
NYS Department of Health
Bureau of Consumer Services
Office of Health Insurance Programs
Corning Tower – OCP Room 1609
Albany, NY 12237
The New York State Department of Health (NYSDOH) obtains drug formulary information from Medicaid participating managed care plans on a quarterly basis. Please note NYSDOH publishes the drug formulary information as it is received. This information was last updated on 2017-08-23. As a best practice, always contact or visit your managed care plan's website to obtain the most current information regarding drug coverage.