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S.794 would require Medicare contractors to hold public meetings and disclose the rationale and evidence underlying an LCD at the start of the process.

The law contains provisions that proponents say will advance precision medicine and speed new tests to market, but critics worry if this will come at a cost to public health.

Originally published Oct. 1.
A new bill strongly supported within the diagnostics industry could put pressure on the Centers for Medicare & Medicaid Services to alter its procedures for setting reimbursement rates for molecular diagnostics.

NEW YORK (GenomeWeb News) – US President Barack Obama yesterday signed a bill into law that will expand the amount of user fees that the Food and Drug Administration collects from industry in the coming years, enact measures to shore up the agency's review resources, and streamline and speed up s

Since genetic tests were not discussed at a public meeting held this week on payment for new codes under the clinical lab fee schedule, "they cannot be priced under the laboratory fee schedule for 2012," a CMS spokesperson said.

Agency officials said during a recent MDUFA meeting that there will be "three guidance documents coming out together that will detail the proposed road forward in oversight of laboratory-developed tests."

FDA Commissioner Margaret Hamburg has hired Steven Spielberg, director of the Center for Personalized Medicine and Therapeutic Innovation at Children’s Mercy Hospital in Kansas City, for the newly created position of deputy commissioner for medical products and tobacco.

"CMS is the decision-maker here regarding fee schedule placement [of genetic tests] and we are pleased they are recognizing the importance … of having stakeholders provide input on the questions they've asked," said David Mongillo, vice president for policy and medical affairs at the American Clinical Laboratory Association.

The two-day meeting held by the agency in Hyattsville, Md., drew comments from numerous LDT developers and in vitro diagnostic companies, each side presenting their views on the current bifurcated regulatory pathway and FDA's stated intent to regulate all LDTs.

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The US Food and Drug Administration has new guidelines that enable some gene and cell therapies to undergo expedited review, according to the New York Times.

Using gene drives to control invasive species might be too risky, an initial advocate of the approach says.

Researchers have grown tumors in 3D cell cultures to better understand cancer, the Economist reports.

In Science this week: intellectual property experts argue patent battles such as the one over CRISPR are wasteful, and more.