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CAP Home > CAP Advocacy > STATLINE – CAP’s Biweekly Federal and State Advocacy E-Newsletter
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  STATLINE — CAP’s Biweekly Federal and
  State Advocacy E–Newsletter

August 28, 2014  •  Volume 30, Number 18
Next Issue: September 11, 2014
© 2014 College of American Pathologists

In This Issue:

Special Report:
Analysis of FDA LDT Draft Guidance; Register for CAP Webinar September 3

Citing increased complexity and expansion of laboratory developed test (LDTs) in the health care system, the US Food and Drug Administration (FDA) will exercise its enforcement authority and increase oversight of LDTs.

On September 3, the FDA will review its draft guidance for regulating LDTs during a webinar hosted by the CAP. The presentation, “FDA’s Plan to Regulate Laboratory Developed Tests,” will feature FDA Director of the Office of In Vitro Diagnostics and Radiological Health Alberto Gutierrez, PhD; CAP Council on Government and Professional Affairs Chair George F. Kwass, MD, FCAP; and CAP Council on Scientific Affairs Chair R. Bruce Williams, MD, FCAP. CAP members are invited to register for the webinar and participate on September 3 from 1-2 pm EDT.

The main elements of the framework, released on July 31, include notification to the FDA of LDTs manufactured by a laboratory; continued enforcement discretion regarding low-risk LDTs, traditional LDTs, LDTs used for rare diseases, and LDTs for unmet needs; and, a risk-based, phased-in approach to enforcing review requirements for high-risk and moderate-risk LDTs. Oversight also would involve the use of clinical literature to support clinical validity.

Over the past decade, the number, complexity, and importance of LDTs in diagnosing and treating disease have increased dramatically, creating the need for strengthened oversight that will ensure public safety. Responding to this need, the CAP had proposed a risk-based model employing a public-private partnership to address oversight of LDTs in an inclusive, systematic way. The CAP’s proposal relied on third-party accreditors and inspectors to oversee and monitor standards for low- and moderate-risk LDTs; high-risk LDTs would be reviewed directly by the FDA. The CAP had presented this model to the FDA, and now continues to be engaged with the agency.

“The CAP has already spoken with the FDA to gain more clarity on the draft guidance,” Dr. Kwass said. “We will provide comments on the proposed framework during the open comment period and public meetings, and work with the FDA and other stakeholders to develop workable LDT regulations.”

Draft LDT Regulatory Framework

The FDA in the draft guidance defines an LDT as a diagnostic device “intended for clinical use and designed, manufactured, and used within a single laboratory.” For instance, a laboratory develops a new diagnostic test using peer reviewed articles. The laboratory then develops a testing protocol that is verified and validated within the laboratory. The test is then used to provide clinical diagnostic results.

LDTs have evolved rapidly over the last several decades. In 1976, the FDA observed, LDTs were mostly manufactured by local laboratories and were utilized in small numbers. But over time, the landscape changed dramatically with LDTs “frequently manufactured with components and instruments that are not legally marketed for clinical use and also rely more heavily on high-tech instrumentation and software to generate results and clinical interpretations.”

“Moreover, technological advances have increased the use of diagnostic devices in guiding critical clinical management decisions for high-risk diseases and conditions, particularly in the context of personalized medicine,” the FDA stated.

Proposed Notification Requirement

The draft oversight framework would require laboratories to engage in new activities with the FDA. Laboratories would be required to notify the FDA of the LDTs they produce as the agency implements its risk-based framework. The notification data would help the FDA advisory panels make recommendations on LDT risks, classification, and prioritization of enforcement, the agency said. In addition, the data collected from the notification process would be made publically available.

Within six months of the publication of the FDA’s final guidance document, laboratories would notify the agency that they manufacture LDTs or else be required to go through the agency’s registration and listing requirements. Instructions for how laboratories notify the FDA were printed in the draft guidance document, “FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTS).”

“The notification system described above will be a critical element of the LDT oversight framework, as it will provide the agency with the necessary information on the LDTs being currently manufactured by clinical laboratories to assist the agency in implementing the enforcement of premarket requirements for LDTs based on their risk,” the FDA said.

Laboratories would submit LDT information online in order to meet the notification requirement. Notification is expected to occur once for each LDT, but laboratories should resubmit notification information when significant changes are made to an LDT, the agency said.

Risk-Based Approach Toward Oversight

The FDA’s oversight framework aims to assure that LDTs are safe and effective, agency officials said. In simple terms, the level of oversight will depend on the type and scope of LDT.

“Ensuring that doctors and patients have access to safe, accurate and reliable diagnostic tests to help guide treatment decisions is a priority for the FDA,=” said FDA Commissioner Margaret A. Hamburg, MD. “Inaccurate test results could cause patients to seek unnecessary treatment or delay and sometimes forgo treatment altogether. Today’s action demonstrates the agency’s commitment to personalized medicine, which depends on accurate and reliable tests to get the right treatment to the right patient.”

LDTs would be classified as low-risk, medium-risk, or high-risk under the tiered framework. The FDA would consider several factors when determining the category for each LDT. For instance, regulators would determine if it’s “intended for use in high risk disease/conditions or patient populations, whether the device is used for screening or diagnosis, the nature of the clinical decision that will be made based on the test result, whether a physician/pathologist would have other information about the patient to assist in making a clinical decision (in addition to the LDT result), alternative diagnostic and treatment options available to the patient, the potential consequences/impact of erroneous results, number and type of adverse events associated with the device, etc.” The FDA plans to issue draft guidance regarding the risk levels within 18 months of finalizing its overall framework.

“FDA intends to focus its efforts on the highest risk devices first and gradually phase in enforcement for other devices over time,” the agency said. “In this manner, it is FDA’s intention to avoid undue disruption of medical testing while seeking to assure patient safety and to assure that health care practitioners are relying on device results that are meaningful and accurate when making medical decisions.”

High-risk LDTs would go through the FDA’s registration and listing process, which involves agency review and approval. Devices would remain on the market as the FDA considers applications.

Moderate-risk LDTs would go through registration and listing, but also would have the notification process option. The FDA intends to utilize FDA-accredited third party review of premarket submission for this category.

As for low-risk LDTs, the FDA will exercise enforcement discretion regarding additional regulatory oversight. In addition, enforcement discretion will be applied to traditional LDTs and LDTs to diagnose rare disease. The FDA considers tests developed to diagnose a disease or condition with an incidence of fewer than 4,000 patients a year to be in the rare disease category. Traditional LDTs are those that reflect the types of LDTs available when the FDA began its policy of enforcement discretion in 1976.

Traditional LDTs meet the FDA’s LDT definition, are developed within a facility’s health system to ensure patient outcomes, and ensure a level of quality through the use of only legally marketed components and instruments.

Adverse Events Reporting

Laboratories will be subject to medical device reporting requirements to identify and monitor for adverse events.

Clinical laboratories must report individual adverse events within 30 calendar days after they become aware of information that suggests an LDT:

  • May have caused or contributed to a death or serious injury,
  • Malfunctioned and it, or a similar LDT, they manufacture likely caused or contributed to death or serious injury.

The FDA guidance also details requirements regarding the submission of reports of individual adverse events no later than five working days after the laboratory becomes aware of a reportable event that necessitates remedial action to prevent harm to public health. Supplemental reports would be required within one month from the day the laboratory receives reportable information that was not submitted in an initial report.

Timeline for Implementation

The implementation of the regulatory framework involves several steps and will take years, if not a full decade, to complete.

The FDA’s July 31 release of the draft framework was the start of a 60-day notification period, which will be followed by a six-month public comment period. The final LDT guidance would come after the FDA reviews the comments.

Once the guidance is final, laboratories will have six months to notify the FDA that they are developing LDTs. Adverse events also must be reported during the first six months.

The LDT categories will be phased-in based on risk, starting with the highest of the high-risk LDTs for premarket review, a year after the guidance becomes final. The FDA plans to create a priority list of the remaining high-risk LDTs within 24 months from the final guidance. The FDA expects phased-in enforcement of Class III LDTs will be completed within 5 years. Phased-in enforcement of premarket regulatory requirements for Class II devices would be completed within 9 years.

New PathNET System Will Help CAP Members Advocate for Pathology

The CAP has revamped its PathNET program to build a stronger grassroots network of well-trained and active members.

The College implemented the changes and informed current PathNET members about new enhancements earlier this month. The new PathNET will further assist pathologists who are engaging with elected officials, and building relationships with their legislators, in advancing the practice of pathology.

The new PathNET will include training and resources to create active, engaged PathNET members. For instance, the CAP is developing templates, sample presentations, and “How To” guides for grassroots activities. Further, the CAP will develop a series of webinars and conference calls to help train grassroots advocates.

PathNET also will introduce a membership system that will be divided into tiers, based on level of activity. The tiers are:

  • Tier 1: Grassroots Advocate Level, for members who take action in at least three different types of engagement annually—Action Alerts, social media, Letters to the Editor, PathNET recruitment, and state pathology society membership.
  • Tier 2: Grassroots Activist Level, for members who participate in the Tier 1 activities as well as meet with their member of Congress at least twice annually. Members can do so by leading a lab tour if they have not done so in the last three years, participating in an in-district meeting with their legislators, or attending legislator town hall meetings to raise issues of concern to pathologists.
  • Tier 3: Grassroots Ambassador Level, for members who participate in Tiers 1 and 2 activities and serve as a member of a legislator’s health care advisory committee, participate in a “fly-in” to meet with legislators in Washington, DC, attend the CAP’s annual Policy Meeting and participate in Hill Day, or attend a political fundraising event on behalf of CAP.

If you are a current PathNET member or interested in joining PathNET, please complete this short, 5-minute survey to let us know your level of interest in the new program.

The CAP will assist members on utilizing the PathNET system. For more information or questions, please contact Laura Brigandi at 202-354-7128 or

Strengthen Pathology Representation at the AMA

CAP President Gene N. Herbek, MD, FCAP, urged CAP members to join or renew their American Medical Association (AMA) membership to ensure pathologists have a strong voice and vote as the national physician and medical student resident organization debates and decides health care policy.

“The size of our delegation is determined by the number of CAP members who are also AMA members,” Dr. Herbek wrote in his August column for CAP TODAY. “The House of Delegates is medicine’s policymaking body, and your AMA membership is a vote for pathology.”

This underscores the importance of CAP members joining the AMA. Further, Dr. Herbek highlighted several recent examples where pathologists engaged in important issues affecting the specialty and quality of patient care. For instance, the AMA Council on Ethical and Judicial Affairs recommended changes to the association’s Code of Medical Ethics. Specifically, proposed changes would remove language that supports direct billing and anti-markup of laboratory or pathology services. The CAP spoke in opposition to the changes as they would have huge unintended consequences that are not in patients’ best interests.

“This discussion will continue when CEJA reports on progress at the interim meeting in November,” Dr. Herbek said. “The opportunity to make your voice heard on such matters is an excellent reason to keep your AMA membership current.”

Information about joining or renewing AMA membership is available online.

New Deadlines Set for ‘Sunshine Act’ Data Review

Pathologists now have until September 8 to review data on payments and gifts from industry groups reported on the CMS’ Open Payments system.

The Open Payments system had been taken offline to investigate a reported data integrity issue earlier in August. With the system down temporarily, physicians, teaching hospitals, and authorized representatives could not register and review the disclosure data reported by industry groups. The website reopened on August 15 and can again be accessed online.

On June 1, manufacturers and group purchasing organizations began sending data to the CMS on payments to physicians and teaching hospitals for the last five months of 2013. These industry groups are required by law to disclose certain payments under the Physician Sunshine Act.

As a result of the system being unavailable for about 12 days, the CMS extended the time for physicians and teaching hospitals to review their records to September 8. The records will be publicly available on September 30.

The CAP has joined the AMA, and more than 100 physician specialty and state society organizations, in calling for delaying the data release until March 31, 2015, in order to ensure accuracy by giving physicians enough time to review and dispute data.

Pathologists can submit questions about the Open Payments site in an email to a CMS help desk at Live Help Desk support is available by calling 1-855-326-8366, Monday through Friday, from 7:30 am to 6:30 pm CT.

Massachusetts Enacts Disclosure of Laboratory Ownership Law

A Massachusetts law now requires clinical laboratories to report to state officials its ownership interests or pay civil penalties of up to $5,000.

The new disclosure requirement was included in the 2015 state budget signed into law by Governor Deval Patrick. It requires disclosure of ownership interests by clinical laboratories in writing to the state Department of Public Health and Attorney General’s Office every two years.

Effective July 1, the law allows for the state to levy fines up to $5,000 when entities violate the disclosure law.

State officials sought to enact the disclosure law following settlements with seven laboratories through the Attorney General’s Medicaid Fraud Division, which recouped more than $30 million to the state MassHealth system. A majority of cases involved false claims and kickbacks, but several of clinical laboratories began their businesses by performing frequent testing on residents of sober houses owned, directly or indirectly, by clinical laboratories.


202-354-7100  •  202-354-8101 (fax)  •  800-392-9994


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