AdvaMed

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.

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.

Donal Quinn, Duncan Whitney