ACLA Uses Cancer Initiative to Lobby on PAMA, LDTs

The American Clinical Laboratory Association (ACLA) has applauded the Obama Administration’s proposal for a $1 billion cancer “Moon Shot Task Force” that would drive researchers closer to a cure for the disease. But the lobbying organization also asked that more earthly matters not be ignored at the expense of the new initiative.

According to a Feb. 9 letter sent to Vice President Joe Biden by ACLA President Alan Mertz, the lobbying group asks specifically for more attention regarding regulatory intrusion into the way labs conduct business and how they are reimbursed from government payers.

Specifically, the ACLA asked that the U.S. Food and Drug Administration (FDA) not be allowed to regulate laboratory-developed tests—a contentious issue in the laboratory sector. The FDA has issued draft guidance on regulation, to which labs have objected. “Often LDTs are the only available options for clinicians and patients, particularly when it comes to cancer. Additional FDA oversight through the proposed Guidance would institute an arduous and unnecessary regulatory barrier,” Mertz wrote. “Therefore, in order to support the goals of the Cancer Moonshot Task Force and facilitate the continued unfettered development of new diagnostics, the FDA should withdraw” the draft guidance.

Specifically, the ACLA asked that the U.S. Food and Drug Administration (FDA) not be allowed to regulate laboratory-developed tests—a contentious issue in the laboratory sector. The FDA has issued draft guidance on regulation, to which labs have objected. “Often LDTs are the only available options for clinicians and patients, particularly when it comes to cancer. Additional FDA oversight through the proposed Guidance would institute an arduous and unnecessary regulatory barrier,” Mertz wrote. “Therefore, in order to support the goals of the Cancer Moonshot Task Force and facilitate the continued unfettered development of new diagnostics, the FDA should withdraw” the draft guidance.

“ACLA supported the legislative changes and has sought to collaborate with the Centers for Medicare & Medicaid Services since the enactment of PAMA,” Mertz wrote. “We are hopeful that a predictable market-based payment model, which reflects the broad scope of the laboratory market, will encourage continued advancements in diagnostic innovation.”

Takeaway: Labs are using the Obama administration’s desire to fund cancer eradication efforts to support their own agenda.