The Centers for Medicare and Medicaid Services (CMS) March 4 proposed covering screenings for hepatitis C virus (HCV) in adults eligible for Medicare Part A or enrolled in Part B. The agency said it is seeking comments by April 3 on the proposal, and it expects to complete a national coverage analysis by June 2. In the proposed coverage decision, CMS said screening adults “is reasonable and necessary for the prevention or early detection of an illness or disability.” Currently, HCV screening isn’t covered by Medicare. The coverage analysis was generated internally, the agency said. CMS said screenings would need to be conducted with the appropriate Food and Drug Administration-approved or -cleared laboratory tests “used consistent with FDA approved labeling and in compliance with the Clinical Laboratory Improvement [Amendments] (CLIA) regulations.” The agency said it would cover a screening only if a beneficiary was at “high risk” for infection. If the beneficiary wasn’t considered “high risk,” a single screening test would be covered for adults who were born from 1945 through 1965. CMS defined those at “high risk” as persons with a current or past history of illicit injection drug use and persons who have a history of receiving a […]
The Centers for Medicare and Medicaid Services (CMS) March 4 proposed covering screenings for hepatitis C virus (HCV) in adults eligible for Medicare Part A or enrolled in Part B.
The agency said it is seeking comments by April 3 on the proposal, and it expects to complete a national coverage analysis by June 2.
In the proposed coverage decision, CMS said screening adults “is reasonable and necessary for the prevention or early detection of an illness or disability.” Currently, HCV screening isn’t covered by Medicare. The coverage analysis was generated internally, the agency said.
CMS said screenings would need to be conducted with the appropriate Food and Drug Administration-approved or -cleared laboratory tests “used consistent with FDA approved labeling and in compliance with the Clinical Laboratory Improvement [Amendments] (CLIA) regulations.”
The agency said it would cover a screening only if a beneficiary was at “high risk” for infection. If the beneficiary wasn’t considered “high risk,” a single screening test would be covered for adults who were born from 1945 through 1965.
CMS defined those at “high risk” as persons with a current or past history of illicit injection drug use and persons who have a history of receiving a blood transfusion prior to 1992. Repeat screening for high-risk persons is covered annually only for those who have had continued illicit injection drug use since the prior negative screening test, the agency said.
According to the agency, hepatitis C is an infection that attacks the liver and leads to inflammation. It is often asymptomatic and can go undiagnosed for decades. It is difficult for the human immune system to eliminate the HCV, and it is a major cause of chronic liver disease. HCV is a bloodborne infection, and risks for transmission are primarily associated with exposure to contaminated blood or blood products via transfusions, shared needles, and reused medical supplies, the agency said.
In the United States, for the population already infected with HCV, veterans and baby boomers (those born between 1946 and 1964) are most at risk for becoming symptomatic. Veterans have an infection rate at least three times that of the general population, and baby boomers, who make up about 30 percent of the U.S. population, account for two-thirds of the people with HCV in the United States, CMS said.
FDA-Approved Tests, Treatments
Numerous laboratory tests that can detect the presence of HCV antibody, as well as HCV polymerase chain reaction tests, are FDA-approved or -cleared and available, CMS said.
In terms of hepatitis C treatment, FDA in the past several years has approved two protease inhibitors, Victrelis (boceprevir) and Incivek (telaprevir), for the treatment of genotype 1 infection, CMS said. These anti-virals are commonly referred to as direct acting anti-virals (DAAs). The use of a DAA in combination with interferon and ribavirin is commonly referred to as triple therapy, CMS said.
In November 2013, the FDA approved a third anti-viral called Olysio (simeprevir), which is a protease inhibitor indicated for HCV genotype 1 infection. Olysio is marketed by Raritan, N.J.-based Janssen Pharmaceuticals, part of Johnson & Johnson.
The FDA in December 2013 also approved Sovaldi (sofosbuvir) to treat chronic hepatitis C virus infection. Sovaldi is the first drug that has demonstrated safety and efficacy to treat certain types of HCV infection without the need for coadministration of interferon, the agency said. The drug is marketed by Foster City, Calif.-based Gilead Sciences Inc.
Takeaway: Medicare may soon begin covering screening of certain high-risk eligible adults for the hepatitis C virus.
