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February 01, 2018
In early January, the Centers for Medicare & Medicaid Services (CMS) published a Request for Information outlining its interest in receiving input from stakeholders on the regulations governing the Clinical Laboratory Improvement Amendments of 1988 (CLIA). CMS indicated it was interested in receiving public input on the CLIA regulations pertaining to personnel, proficiency testing referral, histocompatibility, fees and other issues of concern. The issue that is most likely of interest to laboratory professionals concerns CMS’ proposal to enable individuals with a bachelor’s degree in nursing to perform high complexity testing and to serve as a technical consultant in a moderate complexity laboratory. ASCP is concerned with this proposal.
In June 2016, the ASCP Board of Certification (BOC), ASCP, and the American Society for Clinical Laboratory Science strongly opposed a policy adopted by CMS that a bachelor’s degree in nursing is the same thing as a bachelor’s degree in biology. In our 2016 letter to CMS, we argued “the nursing degree is not intended to be, nor should it be viewed as, the equivalent of a degree in biological sciences or any other natural science degree required of laboratory testing professionals to perform…high complexity diagnostic testing services.” The ASCP BOC and ASCP plan to submit formal comments on the rule in advance of its March 12 deadline.
On Jan. 17, ASCP submitted formal comments to CMS challenging a proposal to limit Medicare reimbursement for Next Generation Sequencing tests to only those that have been approved by the Food and Drug Administration. A central concern for ASCP is that the policy could later be expanded to prevent Medicare from reimbursing laboratory developed tests (LDTs) more broadly. The CMS proposal was outlined in a National Coverage Determination (NCD) document announcing that Medicare will provide coverage for the FoundationOne CDx (F1CDx) next generation sequencing (NGS)-based test with companion diagnostics.
In its letter to CMS, ASCP noted that “because the NCD imposes a no-coverage policy for tests that do not satisfy the criteria outlined in the NCD, CMS would not reimburse novel NGS LDTs (and possibly other laboratory methodologies) developed by clinical laboratories and academic medical centers for in-house use, even if they are currently provided coverage via a Local Coverage Determination.”
ASCP argued that “CLIA is an appropriate regulatory oversight scheme that focuses on the accuracy and reliability of the testing process, with specific requirements for analytic quality control, proficiency testing, testing personnel qualifications, laboratory test reports, and documentation of standard operating procedures.” Further, ASCP indicated that the proposed NCD could undermine the ability of clinical laboratories to provide patients and their providers with the diagnostic services, such as LDTs, that may be best-suited to their medical needs. It is not known exactly how many LDTs are currently in use today, but several estimates put that number in excess of 30,000.
ASCP is pleased to report that Paul Farmer, MD, PhD, a member of ASCP’s Partners for Cancer Diagnosis and Treatment Steering Committee, has been selected by the National Academy of Sciences to receive its prestigious 2018 NAS Public Welfare Medal. Dr. Farmer, co-founder and chief strategist of Partners In Health (PIH), is being recognized for developing pioneering treatment strategies that demonstrate the delivery of high-quality health care in resource-poor areas. Dr. Farmer firmly believes “tissue is the issue” and that cancer, like all diseases, is disproportionately affecting the impoverished for which diagnostics are a key element in best care. Congratulations to Paul Farmer on earning the National Academy of Sciences Public Welfare Medal! Read more and join us in congratulating Dr. Farmer via your social media channels here!
CMS Administrator Seema Verma indicated that the Agency will establish an interagency task force to examine the regulatory barriers posed by the Stark law and anti-kickback laws. Administrator Verma indicated the Agency is concerned that these and other laws may be slowing down the transition to value-based care. The interagency task force will include CMS, the Health and Human Services Office of Inspector General, the HHS Office of the General Counsel, and the Department of Justice. ASCP is a founding member of the Alliance for Integrity in Medicare, and strongly supports federal and state self-referral prohibitions, anti-markup requirements, and other measures to prevent clinical providers from profiting on their patient referrals for anatomic pathology and clinical laboratory services. As such, we will be providing comments to the CMS Interagency Task Force to apprise them of our concerns, as representatives of patients and a referral-based specialty.
On Jan. 17, HHS suspended implementation of the 2017 revisions to the Federal Policy for the Protection of Human Subjects, also known as the Common Rule. Many of the provisions of the Common Rule were scheduled to be implemented on Jan. 19, 2018. The suspension delays implementation of the Interim Final Rule until July 17, 2018. However, in the Interim Final Rule announcing the delay, HHS indicated that the federal government will be working on developing a proposed rule that may further delay implementation of certain provisions of the 2017 update to the Common Rule. Several stakeholders, such as the Association of American Medical Colleges and the American Medical Informatics Association, have argued that the timetable for implementing the 2017 changes was not feasible. In the meantime, regulated entities will be required to comply with the pre-2018 Common Rule, which was published in the 2016 edition of the Code of Federal Regulations. ASCP had submitted comments stating our concerns of that rule. ASCP’s comments can be retrieved here.
For more information regarding ASCP's advocacy initiatives and policy positions, please contact ASCP's Center for Public Policy at (202-347-4450).
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