ACLA represents the interests of the clinical lab in an uncertain regulatory climate

By: Alan Lenhoff   
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Julie Khani
Julie Khani
Executive Vice President,
American Clinical Laboratory Association



Professional:

I joined ACLA as a senior vice president in July 2013, and was promoted to executive vice president in March 2016. Prior to joining ACLA I was vice president, public policy, for the National Association of Chain Drug Stores (NACDS).

Education:
BA, New York University; MPA, George Washington University

For readers who are unfamiliar with the organization, how would you characterize the mission of the American Clinical Laboratory Association? ACLA advocates for laws and regulations recognizing the essential role that laboratory services play in delivering cost-effective healthcare; encourages the highest standards of quality, service and ethical conduct among its members; and promotes public awareness about the value of laboratory services in preventing illness, diagnosing disease, and monitoring medical treatment.

Who is eligible to be a member of ACLA, and what benefits does membership confer? CLIA-certified, CAP-accredited labs are eligible to be considered for ACLA membership. We also have an associate membership for diagnostic manufacturers, suppliers, and others. Membership information is available at www.acla.com.

How does ACLA play a role in advocating for the interests of the profession in terms of public health policy, legislation, and regulatory concerns? What are some current issues on which ACLA is taking the lead? There are several critical issues facing our industry, and ACLA is leading aggressive campaigns to achieve the best outcomes on government policies that impact laboratories and the patients they serve. The laboratory community is working together closely on implementation of the Clinical Laboratory Fee Schedule provisions of the Protecting Access to Medicare Act (PAMA), which changes how laboratories are reimbursed for providing clinical laboratory services to Medicare patients. Reimbursement will be based on private payor data submitted by “applicable laboratories.” A top priority is ensuring that the full laboratory market—hospital laboratories, independent laboratories, and physician office laboratories—is part of the reporting process, so the resulting rates are market-based and Medicare beneficiary access is maintained. We’ve also focused our efforts on the definition of Advanced Diagnostic Laboratory Test (ADLT), making sure the definition in the final rule is consistent with the statute, and includes protein-based biomarkers. Finally, we’re working with the Centers for Medicare and Medicaid Services (CMS), the U.S. Congress, and other stakeholders on a reasonable implementation timeline. The PAMA statute required CMS to publish a final rule by June 30, 2015, with the new rates becoming effective on January 1, 2017. At this point we’re still waiting for the final rule, so the January 1, 2017, effective date is no longer feasible. We want to be sure labs have the necessary time to collect, certify, and submit data, and CMS has sufficient time to analyze the data and calculate accurate reimbursement rates. ACLA recently learned that the final PAMA rule is being reviewed by the Office of Management and Budget, the final step before publication, so we are expecting the rule soon.

Equally important, ACLA is engaged in efforts to reform oversight of laboratory-developed tests (LDTs). We are strongly opposed to the draft guidance issued last fall by the Food and Drug Administration (FDA), which incorrectly classifies LDTs as medical devices and would regulate LDTs through the medical device framework. We believe that, if finalized, the draft guidance would have a chilling effect on the ability of laboratories to innovate and meet the needs of physicians and patients. Instead, we support a legislative pathway, and we are working closely with Congress, FDA, patient groups, diagnostics manufacturers, and other stakeholders on strengthening LDT oversight in a manner that avoids duplicative regulation, encourages innovation, and meets the needs of physicians and patients. We think there is real momentum, and given sufficient time, believe Congress can enact true reform. Finalizing the LDT guidance now would not give Congress the time to advance a new framework, and would not lead to better diagnostics or improved patient care. Furthermore, the House Appropriations Committee has recently gone on record, instructing the FDA to suspend efforts to finalize the LDT guidance, and allow Congress the necessary time to pass legislation that addresses a new pathway for regulation of LDTs.

What does the ACLA see as the greatest challenge facing clinical laboratories today? The legislative and regulatory landscape I’ve just described certainly poses tremendous challenges for laboratories. We continue to advocate for ACLA members and the broader laboratory community for reimbursement that recognizes the value of laboratory services, and a regulatory framework that does not stifle innovation.

You joined ACLA as Senior Vice President in 2013. Tell readers about the career path that led you to ACLA. I began my career in government affairs in Pennsylvania, where I’m from. For me state level advocacy was a great starting point, as I was able to jump in with very little experience and make a measurable impact. I’ve always focused on health issues, working for several provider organizations as well as handling health and labor issues for Ford Motor Company. I feel very fortunate to work for ACLA, representing laboratories whose services influence so many healthcare decisions and have such a broad impact on preventing, treating, and curing disease.

You assumed the position of Executive Vice President in March. What new duties will your new position entail? We have a great team at ACLA! In addition to working with my colleagues on our lobbying, policy, and communications initiatives, I’m also taking on additional responsibilities with our board of directors, budgeting, membership outreach and recruitment, and day-to-day management of the association.

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