Put It on the Board, 8/14

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For AP2, the overarching goal is to give patients access to their results in as seamless a way as possible while maintaining solid relations with clinicians.

Tilton

“We wanted to make sure that we weren’t, in any way, complicating or disrupting a very successful report-delivery mechanism when we are servicing our physician customers directly,” Tilton said.

As labs consider how they will comply with the patient-access rule, the $63 million question is how often patients will make these kinds of requests. That sum is the HHS estimate of how much it would cost annually for labs nationwide to comply with the rule if one in every 200 patients makes a test-report request. If only one in 200,000 asks for test reports, the nationwide tally for labs is tabbed at $3 million.

Neither AP2 nor PAML plans to charge patients for their test reports, as allowed under the rule. Busch, however, said PAML may consider billing a patient who makes a sweeping request—a decade’s worth of test reports, for example.

Busch said she is “not expecting a huge influx of requests” this fall.
“I don’t think the average patient, or the average member of the public, is even aware of these changes in the regulations,” she added. “But you need to be prepared.” —Kevin B. O’Reilly

FDA’s LDT framework draws mixed reviews

The FDA has notified Congress that it will issue draft guidance on laboratory-developed tests. As part of that notice, the FDA outlined a risk-based framework for regulating LDTs that would be phased in over several years.

“The agency’s oversight would be based on a test’s level of risk to patients, not on whether it is made by a conventional manufacturer or in a single laboratory, while still providing flexibility to encourage innovation that addresses unmet medical needs,” Jeffrey Shuren, MD, director of the FDA Center for Devices and Radiological Health, said in a statement.

Laboratories would have to notify the FDA of all their LDTs—except those used in forensics and histocompatibility—and file adverse event reports related to them, said the agency’s July 31 document, which is available at http://j.mp/ldtnotice.

Tests deemed to be low risk would not be required to get premarket review. This category includes LDTs for forensics, histocompatibility, rare diseases, those performed using class one devices, or tests for which there is no equivalent FDA-approved or cleared device. Traditional LDTs—those used at a single institution in the care of a patient and that require nonautomated interpretation—also would fall into the low-risk category.

High-risk LDTs would include tests performed with class three devices, and these would have to meet premarket review requirements within one to four years of the FDA’s guidance being finalized. Premarket review for moderate-risk LDTs performed on class two medical devices would start in five years, after the high-risk reviews are done.

The FDA’s tiered, risk-based framework is similar to the oversight approach the CAP outlined in April 2010. The College’s regulatory model (http://j.mp/cap-ldtapproach) seeks “targeted FDA review and approval of clinical claims for only high-risk LDTs, with oversight of compliance by laboratories performing high-risk LDTs by CMS and CMS-deemed accreditors.”

The CAP has discussed its oversight proposal with the FDA and will continue to engage with the agency and key stakeholders. It will detail its advocacy on the matter in future editions of “Statline.”

AdvaMedDx voiced support for the FDA’s harder line on LDTs. “FDA oversight of higher-risk diagnostic tests, including companion diagnostics, regardless of the manufacturer, is essential to patient safety,” AdvaMedDx executive director Andrew Fish said in a statement.

Other stakeholders expressed reservations about the agency’s impending action. American Clinical Laboratory Association president Alan Mertz said in a statement that LDTs should be addressed under the CLIA ’88 regulatory framework “rather than impose an additional layer of regulation.” Similarly, AMA board chair Barbara L. McAneny, MD, said in a statement that new regulatory requirements “may result in patients losing access to timely, life-saving diagnostic services and hinder advancements in the practice of medicine.”

The Association for Molecular Pathology, meanwhile, has said that lab-developed tests ought to be considered medical procedures instead of being regulated the way the FDA oversees other tests.

“We are deeply concerned that attempts to regulate providers of these vital medical services as manufacturers will harm patients by reducing access, decreasing innovation, and substantially raising the costs of essential diagnostic testing,” Roger D. Klein, MD, chair of the AMP’s Professional Relations Committee, said in a statement.

The FDA will release its draft guidance sometime after Sept. 29. The public will have a chance to comment and the agency indicated that a public hearing will be held before final guidance is published. —Kevin B. O’Reilly