Hepatitis C Treatment: Most Medicare Beneficiaries Are Not Getting Authorized Generics
The Office of the Inspector General finds that large rebates for higher-cost hepatitis C drugs and lack of formulary inclusion of authorized generics may be influencing the use of higher cost treatments in Medicare.
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Hepatitis C Treatment Restrictions In Spotlight After HHS Report
Study finds one-third of insured adults have access to hepatitis C treatment within 360 days of the first positive test. CDC suggests treating all eligible patients without restrictions and eliminating preauthorization requirements. For state Medicaid programs, 38 states require prior authorization and 12 states have substance use restrictions.
DOJ Enforcement: Talking With US FDA Is Not Enough To Get Credit For Self-Disclosure
Remediation of a problem with FDA is one factor the DOJ considers in assessing whether a company gets credit for self-disclosure of misconduct prior to a criminal investigation, but it wants companies to come directly to the department to divulge wrongdoing.
What Would US FDA Do If Supreme Court Eliminates Or Curtails Chevron Deference?
Lawyers say agency will have to bolster its administrative record as judges tackle complex policy and scientific issues previously left to FDA. Some cases, such as challenges to exclusivity decisions, may be reopened.