FDA approval of Gilead Sciences' Sovaldi—which can cure the ailment but costs about $84,000 for a full 12-week course of treatment—has focused healthcare attention on the cost issue. If all 300,000 Medicare patients projected to be diagnosed by 2015 were to seek treatment with the latest drug after being screened in the new program, the total expenditure could exceed $25 billion. That does not include the cost of screening, doctor visits and other fees.
Hepatitis C is an infection that attacks the liver and leads to inflammation. About 80% of people exposed to the disease develop chronic infection. Of these, 3% to 11% will develop liver cirrhosis within 20 years. In 2010, the Centers for Disease Control and Prevention estimated that 2.7 million to 3.9 million persons in the United States were living with hepatitis C.
The CMS said it will only reimburse for screening for beneficiaries who fall into two categories. The first are those individuals who are considered at high risk for the disease, including individuals who have a current or past history of illicit injection drug use or those who had received a blood transfusion prior to 1992.
The second is for those individuals who were born from 1945 through 1965. This group was singled out since about two-thirds of patients with hepatitis C were born between these years, according to the U.S. Preventive Services Task Force.
The coverage determination brings Medicare into alignment with private insurers who have already been reimbursing for screenings for these individuals.
The decision follows the release of a proposed coverage determination and subsequent comment period.
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