Weekend update

10 days are left in the current Federal Benefits Open Season which ends on December 11.

Congress is in session this coming week. Here’s a link to the Week in Congress’s report on last week’s activities on Capitol Hill.  The report does not reflect the approval of the Senate’s tax reform bill which occurred overnight on Friday. The leadership in the House of Representatives and the Senate now will appoint members of Conference Committee that we seek to reconcile the House and Senate tax reform bills. If successful, the Conference Committee will produce a report that will be sent to the House and Senate for their approval.

The Senate Health Education Labor and Pensions Committee will hold two hearings this week on the implementation of the 21st Century Cures Act which was voted into law last December.

The current continuing resolution funding the federal government expires on this coming Friday December 8. The FEHBlog has every expectation that Congress will extend the resolution for two weeks or into January. There will be no government shutdown.

In an encouraging development,

The U.S. Food and Drug Administration [on Friday November 30] approved the FoundationOne CDx (F1CDx), the first breakthrough-designated, next generation sequencing (NGS)-based in vitro diagnostic (IVD) test that can detect genetic mutations in 324 genes and two genomic signatures in any solid tumor type. The Centers for Medicare & Medicaid Services (CMS) at the same time proposed coverage of the F1CDx. The test is the second IVD to be approved and covered after overlapping review by the FDA and CMS under the Parallel Review Program, which facilitates earlier access to innovative medical technologies for Medicare beneficiaries. 

“By leveraging two policy efforts aimed at expediting access to promising new technologies, we’ve been able to bring patients faster access to a breakthrough diagnostic that can help doctors tailor cancer treatments to improve medical outcomes and potentially reduce health care costs,” said FDA Commissioner Scott Gottlieb, M.D. “The FDA’s Breakthrough Device Program and Parallel Review with CMS allowed the sponsor to win approval for this novel diagnostic and secure an immediate proposed Medicare coverage determination within six months of the FDA receiving the product application.” 

Compared to other companion diagnostics previously approved by the FDA that match one test to one drug, the F1CDx is a more extensive test that provides information on a number of different genetic mutations that may help in the clinical management of patients with cancer. Additionally, based on individual test results, the new diagnostic can identify which patients with any of five tumor types may benefit from 15 different FDA-approved targeted treatment options. Its results provide patients and health care professionals access to all of this information in one test report, avoiding duplicative biopsies.

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