BOSTON – Though criteria for insurance approval for direct-acting antivirals (DAAs) for hepatitis C virus (HCV) are loosening, many patients are still denied by both public and private carriers. Providers and patients should know that it’s worthwhile to appeal these denials; 78.1% (115 of 145) of initial DAA denials were approved on appeal, according to a recent study.
Jane Giang, PharmD, a clinical pharmacist at the University of North Carolina Health System, Chapel Hill, worked with colleagues to conduct a retrospective study of patients at her facility who were prescribed a DAA for HCV between October 2014 and April 2016.
Dr. Giang, in a video interview at the annual meeting of the American Association for the Study of Liver Diseases, said that she works alongside physicians in her clinic to craft appeals, tailoring appeal letters to individual patients’ circumstances.
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In a poster presentation, Dr. Giang and her colleagues presented results from a total of 1,017 patients who were prescribed DAAs for HCV during the study time frame. Of these, three-quarters (n = 794, 78.1%) received initial approval for their medication, while one in five patients (n = 206, 20.2%) had their initial applications denied. The remaining patients either had their cases closed for a variety of reasons, or had pending applications at the time of data analysis.
About half of the patients (n = 496, 48.8%) had commercial insurance. Medicare was the primary insurance for another 207 (n = 20.4%), and Medicaid for 140 (13.8%).
Of the patients whose DAAs were initially denied, 65 (31.6%) of the denials were for fibrosis less than stage F2. Another quarter of patients (n = 57, 27.7%) did not meet approval criteria, and 41 (19.9%) of denials said that the DAA was nonformulary or excluded by the plan. The remaining denials were for missing information or a variety of other reasons.
Half of the patients (n = 504, 49.6%) had F4 fibrosis at the time of application for DAA treatment; 241 (23.7%) had F0 or F1 fibrosis, and the remainder were approximately evenly split between F3 and F4 fibrosis.
When a subset of these denials went through an appeals process, most were eventually approved. Of the 42 denials for less than F2 fibrosis that were appealed, 20 (47.6%) were eventually approved. Of the 40 patients whose applications for DAAs were based on not meeting criteria, 37 (92.5%) were approved on appeal, and of the 32 denials based on plan exclusions or DAAs being nonformulary, 29 (90.6%) were approved on appeal.
When Dr. Giang and her colleagues broke down the numbers by type of insurance, they found that of the 496 patients who had commercial insurance, only 44 (8.9%) eventually received a final denial. Medicare patients had a 3.9% final denial rate, while just one of the 172 patients (0.6%) without insurance who received medication through programs directly from the manufacturer had a final denial.
The largest number of final denials occurred in the group of patients with Medicaid. Of these 140 patients, 25 (17.9%) had a final denial. Dr. Giang said that in North Carolina, providers cannot file appeals for DAA approval on behalf of patients; the paperwork is sent directly to the patient’s home, and patients have to complete and file the forms. She said that she and her colleagues learned to alert these patients to be on the lookout for paperwork, and counseled them to bring the appeal forms into the clinic so that staff could assist them in completing the appeal.
Though Dr. Giang said that her study showed that payer type matters when it comes to reimbursement for HCV care, the “impact of payer type on access to care remains incompletely explored, especially among noninsured patients,” she said.
Dr. Giang reported no outside sources of funding, and no conflicts of interest.
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