Read the latest ASCP policy news from Washington, DC.
Judge Rejects ACLA Request for Expedited PAMA Lawsuit
On May 30, U.S. District Court Judge Amy Berman Jackson denied a motion from the American Clinical Laboratory Association (ACLA) to expedite its lawsuit against the U.S. Department of Health and Human Services over its new laboratory payment rates. ACLA maintains that when CMS created its new Clinical Laboratory Fee Schedule (CLFS) it erred in its payment rate determinations by not seeking out the market rates for laboratory services, as required by statute. CMS’s data collection methodology ignores data from the vast majority of clinical laboratories, particularly hospital and physician office labs, which skews the new payment rates towards the rates received by large reference labs. ASCP supports the ACLA lawsuit and is disappointed with the judge’s decision. As a result, a decision on the ACLA lawsuit may not occur before late summer.
Pathology Section Council Visibility Increased at AMA Annual Meeting
For the first time in recent history, pathologists were seated together at the American Medical Association’s (AMA) House of Delegates (HOD) meeting in Chicago in June 2018. ASCP, the College of American Pathologists (CAP), United States and Canadian Academy of Pathology (USCAP), and National Association of Medical Examiners (NAME) were seated as a group to help increase the visibility that pathology has in the HOD. ASCP and CAP each have three delegates and three alternate delegates while USCAP has two delegates and two alternates who attend the meeting. The NAME is represented by one delegate and one alternate. ASCP, CAP and USCAP also have member representation in the Young Physician Section and the Resident and Fellow Section at the AMA.
A variety of resolutions and issues were discussed at the AMA meeting. The pathology delegation was able to stop a CLIA-Waived Test resolution that would have removed a CLIA certification mandate requirement for physicians who only use CLIA-waived tests and physician performed microcopy. ASCP representatives James Wisecarver, MD, PhD, FASCP (current ASCP President) and alternate William Finn, MD, FASCP (ASCP Past President) both testified at the Reference Committee considering the resolution and helped ensure that the resolution was referred to the AMA Board of Trustees (BOT) for further deliberation. This outcome will allow us to educate the BOT about the importance of this particular CLIA certification mandate.
The AMA adopted a resolution advanced by CAP to curb laboratory benefits management programs that have the potential to deny patients access to pathology and laboratory medicine services.
VHA Subcommittee Endorses Additional Pharmacological Testing
~ This article was written by ASCP Carter Stephen Ainsworth Fellow Deanna Marie Giraldi ~
The Veterans Health Administration (VHA), the largest integrated healthcare system in the United States, recently charged its Clinical Pharmacogenetics Subcommittee, comprised of VHA and non-VHA experts in pharmacology, laboratory medicine, medical genetics, and health services research, with making recommendations on whether specific pharmacogenetic tests should be utilized by VHA healthcare facilities. In a paper published in the Journal Genetics in Medicine, the subcommittee identified 30 drug-gene pairs, all with Clinical Pharmacogenetics Implementation Consortium (CPIC) recommendations of Level A strength and classified each as strongly recommended, recommended, or not routinely recommended before drug initiation. Four drug-gene pairs (13%) have been classified as strongly recommended while twelve (40%) were classified as recommended.
HLA-B*57:01 genotyping before abacavir use, often utilized in HIV treatments, is one of the strongly recommended tests as the presence of the allele, in conjunction with abacavir, increases the risk of hypersensitivity and results in severe and potentially fatal reactions in patients. CYP2C19 genotyping, however, is not routinely recommended as the subcommittee contends alternate tests produce similar clinical information, and no randomized trial demonstrated improved clinical outcomes, such as lower cardiovascular event rates, as a result of the CYP2C19 genotyping. Continual review and rigorous research will aid in the translation of pharmacogenetic advances into tangible patient care.
The increase in pharmacogenetic testing will span beyond the confines of the VHA to affect patients more globally. The Centers for Disease Control and Prevention continuously execute scans of FDA policies, and the Centers for Medicare and Medicaid Services prepare coverage decisions, clinical guidelines, and review to rank evidence supporting the clinical use of pharmacogenetic testing. Currently, all four of the subcommittee’s strongly recommended drug-gene pairs are categorized as "Tier 1" by the CDC, indicating clinical implementation readiness. The VHA recommendations highlight the need for improvements in patient outcomes before pharmacogenetic testing is implemented by large healthcare systems beyond a research context.
Pathologist from NPQR Beta-Site Helps Develop CDC App for Hematologic Disorders
Pathologists who treat patients with varying thrombotic diagnoses or risks now have access to a free, innovative app called the Anticoagulation Manager (ACM). The app was developed by a multidisciplinary team with technical assistance from the Centers for Disease Control and Prevention and the Georgia Institute of Technology. The goal of the app is to assist clinicians in making appropriate decisions when ordering laboratory tests and managing their patients’ anticoagulation treatment.
A notable member of the multidisciplinary team that helped develop the ACM is Marisa B. Marques, MD, FASCP, from the University of Alabama at Birmingham (UAB). UAB is one of the first National Pathology Quality Registry (NPQR) beta-sites and has data actively flowing from its Laboratory Information System to the NPQR dashboard.
ASCP is supportive of technological innovations that serve pathologists and laboratory professionals in their mission to provide high-quality care to patients. We are pleased that a pathologist from an NPQR beta-site is working on technological solutions to address effective use in the laboratory.
National Academies Meeting Urges Development of a National Strategy for Cancer Control
~~ This article was written by ASCP Carter Stephen Ainsworth Fellow Mollie Davidson ~~
The National Academies of Sciences, Engineering and Medicine convened its Committee on a National Strategy for Cancer Control in the United States on June 7, 2018. This meeting focused on two objectives for the committee, which included reflective efforts on the previous decade as well as analyses of productive future strategies.
Speakers at the event recommended that there is a need to develop an evidence-based national plan regarding cancer prevention, diagnosis and treatment. During the committee’s discussions, an emphasis was placed on the need for cost effective practices evolving with recent findings, as well as the need to better communicate these practices with the public. The sharing of data and support from patient care communities, research organizations, and cancer coalitions was also a prominent point of the workshop. As the population is aging and the number of cancer survivors is increasing, the importance of a national strategy is certainly pertinent. The committee closed by promoting collaborative thinking and the unification of a variety of schools of thoughts to accomplish the goal of a national strategy.
CMS to Release Slate of Medicare Proposed Rules
The proposed rule for the Centers for Medicare and Medicaid Services’ (CMS) Quality Payment Program (QPP) is expected within the next two weeks. The QPP was implemented in 2017 and created two tracks for Medicare physician payment: The Merit-based Incentive Payment System (MIPS) and Advanced Alternative Payment Models (APMs). In 2017, ASCP submitted comments on the QPP proposed rule and was pleased that CMS included recommendations from ASCP in its final rule. When the 2018 QPP proposed rule is released, ASCP will review and make recommendations to continue promoting quality patient care and assisting pathologists in satisfying the QPP’s requirements.
Additionally, CMS is also expected to release the proposed rules for the Medicare Physician Fee Schedule and the Medicare Outpatient Prospective Payment System. In previous years, these rules have included provisions to address the opioid epidemic which has an impact on forensic pathologists. We will monitor these rules as they become available and keep our members informed on these matters.
Threats to Certification Materialize, and ASCP Responds
A new threat to certification appears to have emerged at the state level. Recently, the Louisiana and Missouri legislatures have considered legislation that would pose various challenges to certification. Both involved the idea of preventing individuals who were certified from including this term in their professional titles, unless certification is required for the state licensure of that profession. But legislation under consideration in Louisiana took this further by requiring that in order for private certification examinations to be used for licensure purposes, these credentials would have to provide empirical evidence of systemic harm to consumers from the absence of a certification requirement, an exceedingly high bar to meet for any licensed profession. While ASCP and a coalition of like-minded organizations succeeded to amending the Louisiana bill such that it no longer harmed certification, the Missouri bill was signed into law by outgoing Governor Eric Greitens, despite ASCP’s veto request. While Missouri does not license laboratory personnel, it does not appear the legislation will directly affect laboratory personnel there. Still, ASCP is monitoring how the state will interpret this new law.
For more information regarding ASCP's advocacy initiatives and policy positions, please contact ASCP's Center for Public Policy at (202-408-1110).
ASCP ePolicy News is supported by
an unrestricted grant from Hologic.