Megan Robertson, Senior Counsel in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, quoted in Law360 Healthcare Authority, in “FDA and CMS Leaders Unite Over Proposed Lab Test Rule,” by Beth JoJack. (Read the full version – subscription required.)
Following is an excerpt:
Leaders at the U.S. Food and Drug Administration and the Centers for Medicare & Medicaid Services joined forces on Thursday, stressing that the two agencies are on the same page regarding the FDA providing increased oversight of laboratory developed tests, or LDTs. …
In a joint statement, Dr. Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, and Dr. Dora Hughes, acting chief medical officer and acting director of the Center for Clinical Standards and Quality at CMS, emphasized that CMS supports the FDA's proposed rule that would allow that agency to regulate LDTs.
"Both CMS and the FDA believe that patients and their doctors need to know that LDTs are valid," Shuren and Hughes said in the statement.
For those who follow the ins and outs of the FDA, the statement was an attention-getter.
Megan Robertson, senior counsel at Epstein Becker Green, quickly posted the missive for her LinkedIn followers to see.
The interesting part of the joint statement wasn't that it provided new information about how the FDA will regulate LDTs in the future, she told Law360 on Thursday. "It's more like FDA is almost adding another stake in its defense of its position by getting CMS on board with its proposed rule," she said. …
Although the joint statement focuses on how the two agencies support the proposed rule, Robertson said it also serves as a "subtle reminder" to industry leaders that, if finalized, the rule might affect reimbursement for LDTs.
"Not to read too much into the weeds, but we try to kind of anticipate all the possible ripple effects," she said.
