LDT Oversight Framework Debated During Congressional Hearing
The Food and Drug Administration (FDA) provided Congress with more details regarding its draft oversight framework for laboratory-developed tests (LDTs) during a September 9 hearing on Capitol Hill.
The House Energy and Commerce Subcommittee on Health examined the FDA’s risk-based framework for LDT oversight, which the agency sent to Congress on July 31, and gathered testimony at the hearing. The FDA was required to tell Congress when it intends to propose LDT oversight guidance. The proposal, which may not differ much from the oversight framework released in July, may be published on or around October 1.
“Because of the critical role they can play in the decisions patients make with their doctors, these tests—regardless of who develops or manufactures them—must be accurate and reliable,” said Rep. Joseph R. Pitts (R-PA), the subcommittee’s chair. “Any framework adopted must not only prioritize patient safety—which should always be paramount—but also encourage robust investment and allow for continued innovation.”
The hearing was part of the full committee’s broader 21st Century Cures Initiative, which is examining advances in science and technology in the field of medicine. The subcommittee held the hearing on LDTs to better understand the FDA guidance and its impact on LDTs and innovation. The committee heard testimony from the FDA, as well as a number of stakeholders, including those representing laboratories, device manufacturers and patient groups.
The full hearing can be viewed online at the committee’s website. Officials representing the American Heart Association, AdvaMed Diagnostics, American Clinical Laboratory Association, American Association for Cancer Research, and Coalition for 21st Century Medicine also testified before House members during the second half of the hearing.
Once the guidance is proposed, the FDA will gather public comments. The CAP will provide comments on the proposal during the comment period and subsequent public meetings. Already, the CAP has met with the FDA to clarify parts of the oversight framework. The College will work with the FDA and other stakeholders to develop workable LDT guidance documents.
At the hearing, the FDA Center for Devices and Radiological Health Director Jeffrey Shuren, MD, provided initial testimony to the panel. The FDA intends to exercise enforcement discretion for many LDTs. The upcoming proposal also would incentivize innovation, while assuring that patients and physicians can rely on LDT results for making major medical decisions, Dr. Shuren said.
“We believe that LDTs serve an important role in health care and that there are many good tests on the market,” Dr. Shuren said. “Unfortunately, FDA is also aware of faulty or unproven LDTs, including problems with several high-risk LDTs such as: claims for diagnosing ovarian cancer that are not adequately supported with evidence; lack of appropriate controls yielding erroneous results; and falsification of data for determining which breast cancer therapy would be most beneficial. FDA is concerned that people could initiate unnecessary treatment or delay or forego treatment altogether for a health condition, which could result in illness or death.”
Questions, Answers on LDT Draft Oversight Framework
During the CAP’s recent webinar on LDTs, the FDA’s Alberto Gutierrez, PhD, answered questions from CAP members. An archived version of the webinar is available along with the presentation slides to view or download.
Below is a brief overview of the question-and-answer session. Please note that the questions and answers have been edited and shortened for clarity. The full dialogue appears in the archived version of the webinar.
Question: How will laboratories know how to determine the risk categories for LDTs as the FDA implements new guidance?
Answer: In general, the risk categories will depend on the clinical use of the test. In the case of in vitro diagnostic devices regulated over the last 30 years, about half were in the low-risk category, 45% were medium-risk, and 5% were in high-risk. Several factors will determine the level of risk. For instance, what are the consequences of an erroneous result, whether it be a false positive or false-negative, etc.?
Question: During the regulation process, can LDTs still be performed by laboratories if they are moderate- or low-risk tests?
Answer: Absolutely, yes. Everything else is under enforcement discretion when a test is not “called in” to the FDA. As long as it is not called in to the FDA, the test is under enforcement discretion.
Question: If we have an LDT that we can set up in a year, may we proceed with marketing the test or are we on hold until the guidance is final?
Answer: The agency is not changing its policies until the final guidance is issued. Laboratories may still offer new tests that are clinically valid and of high quality.
Question: Does Congress have final approval over the guidance and implementation plan?
Answer: We believe the Food, Drug, and Cosmetic Act 1976 is broad enough and what will be proposed will fit in the definition of the law. That doesn’t mean that Congress cannot change the law. Congress will opine on the guidance and they may decide that there is another way to go—that is their prerogative.
Question: What will notification process look like?
Answer: The notification process will include providing the name of the laboratory, intended use for the test, clinical use of test, and intended patient population. Laboratories should be able to provide notification without too much trouble.
Tricare Again Will Cover Certain LDTs
LDTs again will be covered by Tricare, the federal health care program for the active military, retirees, and their families.
Tricare stopped paying for more than 100 LDTs in 2014. The CAP and several organizations representing pathology and laboratory medicine opposed the move and worked with the Defense Health Agency, which oversees the program, to reinstate coverage.
In July, the Defense Health Agency announced it would cover about 35 LDTs under a new pilot program. The tests are a first wave of assays that the agency considered for coverage. More tests likely will be approved by the end of the year.
Pathologists and geneticists are part of a Tricare laboratory workgroup of experts reviewing coverage issues.
CAP Continues Engagement Regarding Beacon Program in Florida
The CAP remains engaged with UnitedHealthcare regarding the insurer’s implementation of a laboratory benefits management pilot program in Florida, as UnitedHealthcare has expanded the pilot to accept The Joint Commission as an accreditor in addition to the CAP where required under the program.
The pilot requires ordering and rendering physicians to use a decision-support system for laboratory services. It also in some instances requires second reviews, subspecialty certification, and accreditation. The UnitedHealthcare pilot program requires use of the Beacon Laboratory Benefits Solutions Physician Decision Support. Beacon is wholly owned by Labcorp.
Under the pilot that begins in October, physicians must utilize the system and adhere to the pilot’s other requirements. Per United’s communications, physicians who do not do so may face lower fee schedule payments and contract termination.
The program will require Florida physicians and those who receive specimens from Florida ordering physicians for patients enrolled in certain fully-insured UnitedHealthcare products to use Beacon to provide notification for over 80 tests.
UnitedHealthcare is deploying the technology to “make it easier to choose the right tests and laboratories for members using evidence-based guidelines and industry best practices,” the insurer states. In order to perform and bill for any laboratory services under the pilot, CLIA certification is required as is the CAP or, the recently added, The Joint Commission certification for certain complex pathology tests. The advance notification requirement applicable to the greater than 80 tests is to place of service (POS) 11 for office-based services or POS 81 for services provided in an independent laboratory.
Minnesota Delays Medicaid Compliance Date to January 1
The state of Minnesota has delayed the deadline to comply with Medicaid regulations that mandate ordering physicians cannot bill for laboratory and pathology services sent to a hospital or free-standing laboratory.
Physicians and laboratories in the state now have until January 1, 2015 to comply with federal and state law. Previously, the compliance date was October 1, 2014.
Earlier this year, Minnesota health officials corrected a long-standing policy on billing laboratory and pathology services in response to a formal inquiry by the CAP and the Minnesota Society of Pathologists (MSP). The Minnesota Department of Human Services (MDHS) acknowledged the error in a May 30 letter to MSP President Lawrence J. Burgart, MD, FCAP.
Specifically, the policy violated federal Medicaid rules banning one provider from receiving payment for a service another provider completed, state officials said. After working with the CAP, which first identified the error, the MSP questioned a section that stated ordering physicians can choose to bill Medicaid for laboratory and pathology services sent out to a hospital or a free-standing laboratory. However, the policy contradicted the state’s administrative rules stipulating “payment must be made to the provider who performed the service.”
The CMS also stated Minnesota’s Medicaid program cannot pay one provider for a service that another provider completed.
How Pathologists Drive Value in ACOs Discussed at CAP ’14
With more than 650 accountable care organizations (ACOs) now covering 20 million Americans, pathologists are ensuring that their laboratories are integrated in these coordinated care models, said panelists at the September 8 CAP ’14 session, “How Pathologists Bring Value to an ACO.”
The CAP ACO network held a panel discussion on which four of its members presented. Pathologists spoke about their successes and lessons learned in demonstrating value, exercising leadership, and influencing patient and population management within a team-based model.
The CAP has extensive information on coordinated care programs in its ACO/Coordinated Care Resource Center, including tools to assist pathologists. If you work at one of the new Medicare Shared Savings Program ACOs or work at an organization that is currently, or will be part of an ACO, we encourage you to join the CAP’s ACO network by sending us an email. The CAP ACO network provides pathologists with a forum to connect about their ACO experiences and best practices, and to learn from each other and the College about ACO participation.
One panelist, James Crawford, MD, PhD, FCAP, serves as executive director and senior vice president of Laboratory Services for New York’s North Shore Long Island Jewish Health System (NSLIJH). Dr. Crawford said that to be a part of an ACO is an “all in” exercise. All your employees must be on board with leadership and owning all aspects of laboratory services, he emphasized. Panelist Patrick Twomey, MD, FCAP, chief medical officer and chief quality officer of Essentia Health, one of two ACOs in the country with level 3 ACO accreditation by the National Committee for Quality Assurance, underscored that the ACO is not just a division of his organization. The organization is “all in” as an ACO.
NSLIJ currently has 265,000 patients under full or shared risk (40% are under full risk and 60% shared). The system’s laboratory is focused on the overall performance of the health system as that’s what will generate value for the pathologists and laboratory.
NSLIJ’s strategy is to be the laboratory of choice—included in all contracts and products. The laboratory’s value will be driven by three things: 1) integrated laboratory network service delivery, 2) integrated laboratory informatics, and 3) laboratory support of clinical champions.
As to pathologists’ value-added roles in coordinated care arrangements, the panel’s moderator and chair of CAP’s ACO network, Donald Karcher, MD, FCAP, Professor and Chair of Pathology at The George Washington University Hospital in Washington, DC said, “Our challenge is to gain recognition for these roles and get paid fairly for these roles” adding that it’s also key for pathologists to be involved in ACO leadership. This sentiment was shared by other members of the panel including Dr. Crawford, Dr. Twomey and Debra G.B. Leonard, MD, PhD, FCAP, chair and professor, Department of Pathology and Laboratory Medicine, University of Vermont College of Medicine, Fletcher Allen Health Care.
“It’s a question of—are we going to be at the table or on the menu?” Dr. Karcher concluded.
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