James A. Boiani, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in MedTech Dive, in “Testing Overhaul Faces a ‘Narrow Pathway’ to Pass Before Year End, Industry Groups Say,” by Elise Reuter.

Following is an excerpt:

A bill that would create a new, risk-based framework for diagnostic tests has a “narrow pathway” to pass before the end of the year, industry groups told MedTech Dive.

The VALID (Verifying Accurate Leading-edge IVCT Development) Act was initially included in a Senate package to reauthorize the Food and Drug Administration’s user fee programs for the next five years. The act was struck from the final package, along with all other amendments, in a last-minute effort to pass the authorization before the end of the federal fiscal year. Leaders of the Senate Committee on Health, Education, Labor and Pensions and the House Energy and Commerce Committee said they plan to revisit the struck amendments before the end of the year as part of a year-end omnibus spending bill. …

James Boiani, an attorney with New York-based law firm Epstein Becker Green, said in an interview the bill has a “reasonable chance” of passing by the end of year. 

“Even though it has pretty broad support… there have been concerns in the past about disrupting the current LDT framework where lab-developed tests need to be approved,” he added. 

Concerns from academic medical centers

While medtech groups including Advamed have largely supported the proposed regulatory overhaul, some academic medical centers have raised concerns. Several large health systems, the Association for Molecular Pathology and the Association of American Medical Colleges signed a May letter to Congress raising “significant concerns” about the VALID Act. 

“The party that would be impacted most would be the people that are losing the ability to make LDTs,” Boiani said. “The larger clinical labs are probably less concerned about it, maybe in part because New York state manages its own [Clinical Laboratory Improvement Amendments] program and they’ve sort of established their own approval process for evaluating tests.”

Larger testing companies that already had to go through New York might be more comfortable with going through an approval process, he said. 

What will it take to pass the bill? …

The results of mid-term elections in November also may affect what happens with the bill.

“Today, it looks like it has a reasonable chance of passing, but that could change depending on how the elections go,” Boiani said, adding that “the atmosphere on the hill had kind of soured.”  If both houses flip, there would be less incentive to work on the VALID Act, he added. …

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