A client's prescriber or the client with the assistance of the prescriber may request the agency cover a nonformulary drug for the specific client for the treatment of a specific disease or condition. This process is called a nonformulary justification (NFJ).
(1) The medicaid agency only reviews a request for a noncovered service as an NFJ when:
(a) The NFJ is submitted by the prescriber on the form provided by the agency;
(b) The drug is a nonformulary drug; and
(c) The NFJ conforms with the agency's minimum requirements in current published billing instructions, numbered memoranda, provider notices, and any additional requirements in the Washington Administrative Code (WAC) and/or Revised Code of Washington (RCW).
(2) The agency approves, on a case-by-case basis, an NFJ when the agency determines the drug is medically necessary as defined in WAC
182-500-0070. The process the agency uses to assess whether a nonformulary drug is medically necessary is based on evaluation of submitted client-specific information and documentation establishing:
(a) The client's clinical condition is different from the majority of individuals with the same or similar diagnosis whose treatment needs are met within the scope of covered services;
(b) Medical treatment, items of service, and all formulary drugs covered under the client's medical assistance program and which, under accepted standards of medical practice, are indicated as appropriate for the treatment of the illness or condition, have been found to be:
(i) Medically ineffective in the treatment of the client's condition after an adequate trial at the maximum dose approved by the FDA; or
(ii) Medically inappropriate for that specific client.
(c) The requested nonformulary drug can be reasonably expected to successfully treat or improve the client's function and the condition the nonformulary drug is prescribed to treat when other treatments, items of service, and all formulary outpatient drugs covered under the client's medical assistance program have proven to be medically ineffective or inappropriate for the client.
(3)(a) When the agency receives a request for an NFJ, the agency acknowledges receipt within:
(i) Twenty-four hours if the NFJ is received during normal state business hours; or
(ii) Twenty-four hours of opening for business on the next business day if the NFJ is received outside normal state business hours.
(b) Within five business days the agency:
(i) Approves the NFJ if the requested nonformulary drug is medically necessary according to subsection (2) of this section; or
(ii) Denies the NFJ if the requested nonformulary drug is not medically necessary according to subsection (2) of this section; and
(iii) Sends written notification to the client and a facsimile to the client's prescriber of the agency's determination.
(c) The agency's pharmacists or medical consultants have final authority of approval or denial of the NFJ.
(4) Nonformulary drugs which meet all other conditions of coverage with the exception of their nonformulary status are covered services for the specific client for the treatment of a specific disease or condition when approved under subsection (3) of this section.
(5) A client has the right to request an administrative hearing on NFJ denials.
(6) Drugs determined to be noncovered according to WAC
182-530-2100 (1)(a) through (j) will be reviewed according to the exception to rule (ETR) process in WAC
182-501-0160.
[Statutory Authority: RCW 41.05.021 and section 1927 of the Social Security Act. 12-18-062, § 182-530-2300, filed 8/31/12, effective 10/1/12.]