Drug Pricing

CMS Administrator Seema Verma said Tuesday (May 1) that agency staff are working through legal issues in an effort to let states use restricted Medicaid formularies that would give them more leverage in price negotiations with brand drug makers.

The Health Resources and Services Administration withdrew Monday (April 30) a proposed rule to modify an Obama-era regulation on 340B ceiling prices and penalties, according to the White House Office of Management and Budget, which had been reviewing the proposed rule since October.

The Congressional Black Caucus is throwing its support behind 340B hospitals and health clinics, coming as Rep. Doris Matsui (D-HI) also seeks to boost the hospitals by drafting a bill that requires audit parity between 340B hospitals and drug makers.

Rep. Buddy Carter (R-GA) introduced a bill Tuesday (April 24) that would make 340B hospitals report on how many low-income patients are cared for as inpatients and outpatients -- including patients at off-campus pediatric sites.

The U.S Supreme Court decided 5-4 Tuesday (April 24) that the Patent Trial and Appeal Board may not choose to decide the validity of a subset of patents challenged in an inter partes review, and instead must make a determination as to all of the patents challenged.

FDA Commissioner Scott Gottlieb provided the first indications Thursday (April 19) as to what policies are likely to be included in his upcoming plan to boost biosimilar development, namely lowering the bar for demonstrating interchangeability and making it easier for biosimilars to extrapolate across indications -- moves that track with a White House drug pricing report put out earlier this year.

The newly appointed top HHS official on opioid policy faced tough questions Thursday (April 19) from Democrats on the Senate Finance Committee about whether he would take aggressive action against opioid manufacturers and distributors, and the committee’s ranking Democrat, Sen. Ron Wyden (OR), said the committee should summon the executives of those companies to testify about their role in the opioid crisis.

Brand drug maker representatives met with CMS and White House budget officials to push for higher Medicare hospital inpatient reimbursement through changes to the MS-DRG system and the New Technology Add-on Payments, about which industry has raised concerns for years.

The ongoing battle between the insurance industry and a charity that supports end-stage renal disease patients by covering their commercial insurance payments heated up Tuesday (April 17) with both parties seeking immediate action by HHS Secretary Alex Azar.