Read the latest ASCP policy news from Washington, DC.
ASCP-CAP-AMP-ASCO Release New Clinical Practice Guideline Focusing on Molecular Biomarker Testing for Patients with Colorectal Cancer
The American Society for Clinical Pathology (ASCP), the College of American Pathologists (CAP), the Association for Molecular Pathology (AMP), and the American Society of Clinical Oncology (ASCO) collaborated to develop the Molecular Biomarkers for the Evaluation of Colorectal Cancer clinical practice guideline, published in early online release format Feb. 6, 2017. Print publication will follow in the respective organizational journals.
This pivotal guideline addresses testing a wide range of molecular biomarkers in patients with early and advanced colorectal cancer. It will help establish standard molecular biomarker testing, guide targeted therapy decisions, and advance personalized care for patients with colorectal cancer, which is the second leading cause of cancer-related death in the U.S. for women and men combined (American Cancer Society, Cancer Facts & Figures 2017).
“While many existing recommendations cover the application of individual molecular biomarkers in colorectal cancer, this guideline fills the need for an overarching set of recommendations spanning the breadth of current knowledge,” said Wayne W. Grody, MD, PhD, FASCP, FCAP, UCLA School of Medicine, project co-chair on behalf of ASCP. “This comprehensive guideline will prove useful for pathologists and oncologists to support decision-making on what molecular tests to order for patients with colorectal cancer.”
Twenty-one guideline statements were established, based on evidence from a comprehensive literature review of over 4,000 articles, by a multi-disciplinary panel of experts, including pathologists, oncologists, methodologists, and patient representatives. Development utilized an evidence-based process following Institute of Medicine standards, and will be reviewed every four years, or earlier in the event of publication of substantive and high-quality evidence that could potentially alter recommendations.
FDA Incorporates ASCP Recommendations on LDT Regulation
On Jan. 13, the Food and Drug Administration (FDA) released a discussion paper regarding an updated regulatory framework for laboratory developed tests (LDTs). The release of this paper comes two months after the Agency declared that it would not issue a final guidance on this topic. The FDA described the paper as a “conversation-starter” and emphasized that it does not reflect any immediate policy changes.
Recall that in 2014, the FDA released a draft guidance that was met with much resistance from the laboratory community, which led various groups to form and/or advocate for alternative plans in 2015. Each plan had its own risk-classification strategy as well as stances on who should regulated LDTs (i.e., FDA or CMS/CLIA). Throughout the year in 2016, the FDA threatened to release their final LDT guidance, but the Presidential election in November brought a new type of uncertainty to the laboratory community, so the Agency shied away from stronger regulation.
Under the proposal outlined in the discussion paper, the FDA generally stands by its position that a complementary risk-based oversight framework that involves both the FDA and the Centers for Medicare & Medicaid Services (CMS) Clinical Laboratory Improvements Amendments (CLIA) program is the preferred alternative to a CMS-only approach. However, the updated proposal generally scales back the FDA’s involvement and emphasizes the need for regulatory flexibility.
Further, the FDA states that approval would generally be required for “new and significantly modified” LDTs that are moderate- or high-risk. Most existing tests would be grandfathered (meaning exempt from FDA oversight except for adverse event and malfunction reporting), and some newer, riskier tests could be exempt if they treat rare diseases or fall into other categories. In a 2015 letter to the Agency, ASCP advocated for grandfathering of any LDT that has been approved or cleared through the State of New York Department of Health Wadsworth Center, which the FDA agreed to in the paper. ASCP also advocated for the FDA to loosen regulatory enforcement with respect to premarket review for unmet medical needs, which they also adopted.
Additionally, the paper proposes a roll-out of four years as opposed to the originally proposed nine; and asserts that the FDA would handle approvals, while CMS would continue to inspect laboratories. The collaborative approach suggested here was “supported by the broadest array of stakeholders,” FDA officials wrote. “This approach may best streamline effective oversight by taking advantage of each federal agency’s existing structure and strengths.” the FDA also hinted that approvals won’t necessarily be that difficult to obtain; saying that the validity of tests can “often be supported through scientific databases and medical literature.”
With regard to current quality system (QS) requirements, the FDA now proposes aligning certification to CLIA requirements, even though these requirements are not fully consistent with the FDA QS requirements. For LDTs made in a CLIA-certified laboratory, the FDA would focus its assessment on only three requirements that address aspects of test development not covered by CLIA: (1) design controls, (2) acceptance activities, and (3) procedures for implementing corrective and preventive actions. Furthermore, the FDA would expand its third-party inspection program for LDTs so that many of these QS inspections could be conducted by FDA-accredited third parties.
Relatedly, on Jan. 25, the American Cancer Society and 32 other healthcare organizations sent a letter to Senate leadership urging them to update rules for oversight for all diagnostic tests, including LDTs. The letter said that they feel the FDA should “play a critical role in a modernized framework that supports patient safety and access to valid tests.”
It is unclear whether the ideas presented in the discussion paper or the letter to Senate leadership would be supported by the new Administration, which has advocated for relaxation of federal regulations on many fronts. ASCP will continue to monitor any developments in LDT oversight policy.
HHS Embraces ASCP Recommendations on Research Protections
The Final Rule includes enhanced patient protections and reduced administrative burden.
A Final Rule released on Jan. 18 by the U.S. Department of Health and Human Services (HHS) and 15 other federal agencies changes the Federal Policy for the Protection of Human Subjects. The rule, known as “the Common Rule,” will go into effect in 2018. HHS stated in a press release that the Department made significant changes to the rule in response to comments, such as those provided by ASCP.
While supportive of the enhanced patient protections, ASCP raised several concerns about some of the proposals outlined in the proposed rule. In formal comments, ASCP urged the Department to create an exclusion from the rule’s informed consent requirements to shield clinical laboratories that use residual, de-identified biospecimens to validate test instrumentation. Per ASCP’s request, HHS indicated that the final rule removed the proposal that would have required informed consent before non-identified biospecimens could be used. The final rule maintains the current practice with respect to oversight of these specimens.
ASCP also raised concern with a proposal to expand the definition of “human specimen” to include biospecimens, regardless of whether the specimens contain identifiable information. The proposal could have made it difficult to use biospecimens for research unrelated to the purposes for which the specimen was originally obtained. ASCP noted that the continuing expansion of regulatory requirements for investigators could add significantly to the administrative burden and costs on research. HHS has clarified that “researchers will still not have to obtain consent for studies on non-identified stored data or biospecimens.”
NQF Releases Conceptual Framework Implementing IOM Improving Diagnosis in Health Care Report
On Feb. 3, National Quality Forum released a draft report outlining a conceptual framework to operationalize the recommendations of a National Academies of Sciences, Engineering, and Medicine (previously known as the Institute of Medicine) report titled Improving Diagnosis in Health Care. The 2015 report, of which ASCP was a sponsor, found that at least five percent of U.S. adults seeking outpatient care each year experience a diagnostic error. These types of errors contribute to nearly 10 percent of deaths each year, and up to 17 percent of adverse hospital events.
The NQF conceptual framework is intended to facilitate systematic identification and prioritization of measure gaps, and to help guide efforts to fill those gaps through measure development and endorsement.
ASCP Expresses Concern about Recent Immigration Executive Order
ASCP joined with other medical specialty societies in expressing concern about President Donald Trump’s Jan. 27 Executive Order restricting admission of certain foreign nationals to the United States. The Order suspends new refugee admissions for 120 days, significantly reduces the numbers refugees allowed into the United States this year to from 110,000 to 50,000, and bars travelers from seven countries for 90 days.
A Feb. 1 letter developed by the American Association of Medical Colleges and signed by ASCP and 50 other groups stated, “Our organizations are dedicated to promoting a diverse and culturally competent health and biomedical workforce—at home and abroad—that supports improvements in health care, access to providers, breakthroughs in medical research, and equitable health for all patients regardless of their backgrounds.” The letter noted that “Our ability to attract top talent from around the world also enriches the research laboratories at American institutions that are working toward cures, and it has helped position the U.S. as a global leader in medical research, strengthening our economy and bolstering the public’s health.” The Association of Pathology Chairs, the Association of Molecular Pathology, and the College of American Pathologists joined with ASCP in signing the letter.
ASCP also supported a statement released by the Council of Medical Specialty Societies, arguing that the Order“will have a negative impact on patient care, medical research, the education of health professionals, and international scientific collaboration.” The AMA sent a letter to President Trump, expressing concern that the Order is "negatively impacting patient access to care and creating unintended consequences for our nation's health care system."
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