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December 07, 2018
The Chair of the ASCP Board of Certification (BOC) Board of Governors, Susan Harrington, PhD, D(ABMM), MLS(ASCP)CM, recently spoke before the Clinical Laboratory Improvement Advisory Committee (CLIAC) in opposition to CMS’s plans to integrate the nursing degree into the Clinical Laboratory Improvement Amendments’ (CLIA) high complexity personnel regulations. ASCP also addressed several other matters related to CLIA’s personnel requirements.
In January, the Centers for Medicare & Medicaid Services (CMS) outlined a proposal to allow a bachelor’s degree in nursing to satisfy the testing personnel standards for high complexity requirements under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). ASCP and the ASCP BOC strongly opposed that proposal out of a concern that lower personnel standards would adversely affect test quality and patient care.
In her statement, Dr. Harrington also noted that if CMS opens up the CLIA rules to nursing, other allied health degrees with limited amounts of science would soon follow. She warned that this “could undermine the traditional pathways to training of laboratory professionals, which could undermine efforts to ensure clinical laboratories are adequately staffed and able to provide quality patient care.”
During the meeting, Dr. Harrington urged CLIAC to support ASCP’s four key recommendations for changing the CLIA high complexity personnel requirements:
CLIAC is a federal advisory body providing recommendations to the Centers for Disease Control and Prevention, and the Food and Drug Administration on matters relating to laboratory medicine and CLIA enforcement to CMS. To see ASCP’s and other organizational comments provided on the CLIA personnel regulations, click here.
On Nov. 19, ASCP warned the Centers for Medicare & Medicaid Services (CMS) against abandoning its autopsy policy. The Agency is proposing to eliminate its Medicare Conditions of Participation (CoP) regulation that encourages hospital medical staffs to secure autopsies in all cases of medical-legal and educational interest, and unusual deaths (See 42 CFR § 482.22(d)). ASCP argued in a letter to the Agency that CMS’s autopsy policy embodies “the goals of safeguarding quality patient care, ensuring the efficient use of medical resources, and reducing the likelihood of medical errors.”
In defense of its proposal, CMS stated that the Medicare autopsy requirement is “redundant” and that “more detailed, specific requirements regarding medical-legal investigative autopsies are required by individual state law,” to which hospitals would be expected to defer. ASCP debunked this argument, however, pointing out that only a handful of states currently have laws or policies requiring or recommending the performance of autopsies under the conditions outlined in the Medicare CoP requirement. CMS proposed eliminating the autopsy requirement as part of Notice of Proposed Rulemaking that included a number of proposals to eliminate or modify existing Medicare regulations the Agency believes are unnecessary, obsolete, or excessively burdensome.
After identifying the Proposed Rule, ASCP reached out to the National Association of Medical Examiners (NAME) and others to raise concern about the rule and begin formulating a response. ASCP staff also spoke on the topic of the Proposed Rule on Oct. 15 at the NAME Annual Meeting in Palm Beach, FL.
In October 2018, the U.S. Preventive Services Task Force (USPSTF) released for public comment a draft research plan on screening for Vitamin D deficiency in adults. In response, ASCP submitted comments in November supporting the USPSTF research plan and suggested that it should include a focus on social determinants of health with respect to access to both testing and interventions (e.g., supplementation, sun exposure). ASCP, in partnership with the ABIM Foundation, has also released a Choosing Wisely recommendation on Vitamin D:
Don’t perform population-based screening for 25-OH-Vitamin D deficiency.
Vitamin D deficiency is common in many populations, particularly in patients at higher latitudes, during winter months and in those with limited sun exposure. Over–the–counter Vitamin D supplements and increased summer sun exposure are sufficient for most otherwise healthy patients. Laboratory testing is appropriate in higher risk patients when results will be used to institute more aggressive therapy (e.g., osteoporosis, chronic kidney disease, malabsorption, some infections, obese individuals).
The President’s Emergency Plan for AIDS Relief (PEPFAR) appears on track to be re-authorized by Congress through 2023. The U.S. House of Representatives passed HR 6551, the PEPFAR Extension Act of 2018, by voice vote on Nov. 13. The Senate approved the measure unanimously on November 28. President Trump is expected to sign the bill into law.
The program is designed to address the global HIV/AIDS epidemic and help save the lives of those suffering from the disease, primarily in Africa. It is a cornerstone of U.S. global health efforts. ASCP has a Cooperative Agreement with the Centers for Disease Control and Prevention to support the Agency’s PEPFAR mission.
The U.S. Government Accountability Office (GAO) released a new report on Nov. 30 arguing that Medicare is overpaying for clinical laboratory tests reimbursed under the Medicare Clinical Laboratory Fee Schedule (CLFS). In 2017, the Centers for Medicare and Medicaid Services (CMS) adopted a new laboratory fee schedule, as required by Sect. 216 the Protecting Access to Medicare Act (PAMA). PAMA requires CMS to develop a new fee schedule based on payment rate data submitted by select clinical laboratories. The new fee schedule has resulted in payment rate cuts for 88 percent of the tests on the CLFS and could impose several economic challenges for clinical laboratories. Now, GAO is arguing that the payment rate methodology Congress imposed on CMS may be costing the Medicare program approximately $733 million more from 2018 through 2020 than is necessary. In addition, GAO raised concern that CMS has stopped paying bundled payment rates for certain panel tests and is reimbursing each test separately. GAO estimates that “Medicare expenditures could increase by as much as $10.3 billion from 2018 through 2020 compared to estimated Medicare expenditures using lower bundled payment rates for panel tests.” As a point of reference, GAO indicates that Medicare paid $7.1 billion for tests reimbursed by the CLFS in 2017. GAO outlines several steps that could result in harsher cuts for laboratory payments. ASCP has concerns with GAO's methodology, findings and conclusions and is currently reviewing options to comment on the report.
For more information regarding ASCP's advocacy initiatives and policy positions, please contact ASCP's Center for Public Policy at (202) 408-1110.
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