By Stephanie Murg, Managing Director, G2 Intelligence
What a difference a year makes. That was the prevailing sentiment at the opening sessions of the 20th annual meeting of the American Clinical Laboratory Association (ACLA), which runs through today at the Grand Hyatt in Washington, D.C. In the months since the trade group last convened, the Protecting Access to Medicare Act of 2014 (PAMA) became law, the FDA issued draft guidance on laboratory-developed tests (LDTs), and, just weeks ago, the sustainable growth rate (SGR)-based formula for setting Medicare physician payment rates was scrapped. These major policy changes set the stage for a lively ACLA meeting focusing on key reimbursement and regulatory challenges for the laboratory industry.
“The beginning of the twenty-first century has seen an explosion of diagnostic innovation that is rapidly changing the practice of medicine,” said Quest Diagnostics CEO and ACLA chairman Steve Rusckowski in his welcome address. “Clinical labs are at the forefront of this new era and are taking a leadership role in ensuring smart public policy keeps pace with innovation.”
Lauding the recent decrease in government pressure on the Clinical Laboratory Fee Schedule, the Centers for Medicare and Medicaid Services (CMS)’s pledge to shift to value-based pricing, and the permanent SGR fix, Rusckowski turned to the FDA’s proposed approach to regulating LDTs: it is a case of “agency overreach” that has to be stopped, he said.
The regulatory fate of LDTs was also the topic of a dynamic panel discussion moderated by ACLA president Alan Mertz and featuring ACLA’s legal counsel on the matter: former Solicitor General Paul D. Clement, a partner with Bancroft PLLC; Harvard Law School professor Laurence H. Tribe; and Viet Dinh, a partner with Bancroft and professor of law at Georgetown.
For Tribe, LDTs are “services, not articles introduced into commerce.” As for the “enforcement discretion” that the FDA has long purported to have in this area, it is “a fairy tale” and “a desperate move” on the part of the agency, he said, noting his confidence that if the matter should come to litigation, the court would strike down an FDA regulatory scheme. “It is very hard to conceptualize LDTs as devices,” concurred Clement. “What LDTs do is much closer to the practice of medicine.”
On a brighter note, a presentation by Chris Dawe, managing director of Evolent Health, highlighted recent developments in value-based care, which is now garnering support from both sides of the aisle. “It feels like there really is bipartisan momentum in health policy,” he said, looking ahead to the ongoing efforts of CMS to develop and refine alternative payment models as well as the tremendous activity at the state level, including significant expansion of Medicaid.
Keynote speaker Candy Crowley, former chief political correspondent for CNN, also offered the audience a glimpse into her crystal ball. Those expecting any major changes in health care between now and the election will almost certainly be disappointed. “Start looking to 2017 for that kind of thing,” she advised. In the meantime, Crowley suggested savoring what is sure to be a wild ride to the White House. “I think it’s going to be a great race—fierce, exciting, crazy—particularly on the Republican side,” she said, tallying the day’s throwing of hats into the ring. “I count nobody out at this point.”