In the News

ePolicy News March 2018

Mar 05, 2018
Read the latest ASCP policy news from Washington, DC.









ASCP Leading the Way on CLIA Nursing Degree Issue

ASCP and ASCP Board of Certification (BOC) are hard at work with our collaborating laboratory partners to respond to a recent regulatory proposal from the Centers for Medicare & Medicaid Services (CMS). On Jan. 12, CMS released a Request for Information (RFI) seeking input from concerned stakeholders about several policy proposals the Agency is considering as changes to the Clinical Laboratory Improvement Amendments regulations. One of the proposed changes would allow individuals with a bachelor’s degree in nursing to perform high-complexity testing and to supervise laboratory operations as a technical consultant. ASCP and the ASCP BOC are responding to the Agency in several ways. First, we have launched a grassroots Action Alert to allow laboratory professionals and other concerned individuals to write directly to CMS about its plans. We have made the alert available to our partnering organizations and, as of March 1, more than 4,000 letters have been sent to CMS on the regulation. We hope to see several thousand more responses from the laboratory community before the comment deadline closes on March 12.

ASCP, the BOC and our partnering organizations are still working on formal comments on the RFI. These comments propose to recognize certain non-traditional bachelor’s degree routes to performing high-complexity testing (provided the degree holder has completed sufficient biological and/or chemical coursework) as well as clarifying the training needed to perform these tests. Our comments will also urge CMS to require laboratory personnel performing high-complexity testing to be certified by an accredited certification agency. Lastly, our comments propose to classify the histologic processing of anatomic pathology specimens as a high-complexity procedure, requiring that the service must be performed under the direction of a board-certified anatomic pathologist and performed by such a pathologist or by a certified histotechnician or histotechnologist.

We will provide access to our comments and our specific recommendation in the April issue of ePolicy. For more background on this issue and work ASCP and the BOC have done to address this issue, click here. If you haven’t do so, we urge you to use the ASCP eAdvocacy Center and Send CMS a Message about its RFI.



Future of MIPS Called into Question

Recently, both the Medicare Payment Advisory Commission (MedPAC) and the Department of Health and Human Services Secretary, Alex Azar, have called into question the effectiveness of the Merit-based Incentive Payment System (MIPS), which is one payment track providers can choose under the Quality Payment Program.

Many clinicians have expressed concern that the MIPS program is overly burdensome and takes time away from patient care. MedPAC members also contend that reporting requirements under MIPS do not actually improve care because participants can cherry-pick the measures on which to be assessed. In January, MedPAC proposed an alternative voluntary program wherein physicians would be evaluated in a group. Additionally, the White House 2019 budget proposal suggests having the government use claims data and patient surveys to evaluate clinicians, as opposed to requiring them to submit data to CMS.

Relatedly, CMS is asking clinicians to enroll in a study to help determine exactly how burdensome is the MIPS program. To compare workflows, clinicians who are not eligible for the program will also be included in the study. A key incentive to join the study is automatic fulfillment of the Improvement Activities category in MIPS, but it remains unclear whether clinicians will participate in the study.

It is unclear what impact eliminating MIPS might have on pathologists as alternative value-based frameworks, such as patient satisfaction surveys and claims data, may not necessarily and accurately reflect quality of care. This is especially true for those who work in a laboratory with limited patient interaction. ASCP will continue to track developments as they arise.



House Passes Legislation to Address Sickle Cell Disease

On Feb. 26, the House of Representatives passed HR 2410, the Sickle Cell Disease Research, Surveillance, Prevention, and Treatment Act, introduced by Representatives Danny Davis (D-IL) and Michael Burgess (R-TX). ASCP is a participating member of the Sickle Cell Disease Coalition, run by the American Society of Hematology, and is helping to shepherd the legislation through Congress. ASCP joined with 66 other organizations in a recent letter to members of Congress, calling on them to support the bill.

This bipartisan measure would provide the Centers for Disease Control and Prevention (CDC) with needed authority to carry out programs related to Sickle Cell Disease (SCD). The measure also supports furthering CDC’s population-based surveillance system for SCD and reauthorizes the SCD treatment grants awarded by the Health Resources and Services Administration (HRSA) to improve access to care and quality of care for individuals with SCD. A similar measure, S.2465, in the Senate was introduced by Sen. Tim Scott (R-SC) on Feb. 26.



CMS Releases QCDR and MIPS Resources

The Centers for Medicare and Medicaid Services (CMS) recently released two resources for providers participating in a Qualified Clinical Data Registry (QCDR) such as the NPQR, and for those participating in the Merit-based Incentive Payment System (MIPS).

On Feb. 22, CMS posted measure specifications for the approved 2018 QCDR measures. This file allows users to see measures grouped by specialty and topic to see which measures might be most applicable to their practice and/or specialty.

On Feb. 21, CMS posted a video that demonstrates a new feature that will allow a user from a group submitting quality measures for MIPS using a claims-based submission method to log in and view their monthly calculation of those claims-based measures. These claims can be viewed before the end of the claims period, giving providers who chose this method a projection and better sense of where they stand in the program.



Chronic Kidney Disease Assessment and Diagnosis

February marked the launch of a collaborative initiative between the National Kidney Foundation (NKF), ASCP, and the nation’s leading laboratories to remove barriers to testing for chronic kidney disease (CKD). The goal is to standardize the tests used to detect CKD, improve comparison of test results among laboratories, increase early recognition of the disease and promote patient awareness of the condition.

Of the almost 75 million Americans at risk for developing CKD, approximately 30 million people will develop CKD with only about 3.6 million aware that they are at risk. CKD is asymptomatic at its onset, and its progression can be slowed or halted in its early stages. Guidelines1 recommend regular CKD testing for people at risk for CKD, which includes those living with diabetes and/or hypertension. Currently, 94% of patients with hypertension and 61% with diabetes are not receiving both tests necessary to detect and assess CKD. As CKD progresses, the risk for cardiovascular events, mortality, and kidney failure dramatically increases. The tests used to diagnose CKD have been shown to be strong predictors of both cardiovascular mortality and kidney failure risk.

To improve CKD diagnosis, a new “Kidney Profile” is being recommended. Laboratories adopting the Kidney Profile will simplify ordering of the tests needed to detect and diagnose CKD by pairing estimated glomerular filtration rate (eGFR) and urine albumin-creatinine ratio (ACR) together under one heading on the laboratory requisition form or electronic health record order. Such streamlining of CKD test ordering could help to eliminate the need to search for each test separately and increases the ease of monitoring results. The “Kidney Profile” also makes it easier for people at risk for CKD to better understand and track their health.

For more information regarding this important collaboration, read the press release and quote sheet, and review the laboratory engagement plan and other professional resources on the ASCP CKD webpage.

1. Inker, L.A., et al., KDOQI US commentary on the 2012 KDIGO clinical practice guideline for the evaluation and management of CKD. American Journal of Kidney Diseases. 2014; 63(5): p. 713-35.



Developing a Formidable Oncologic Pathology Workforce: A Presentation by Ritu Nayar, MD

The National Cancer Policy Forum organized a workshop on improving cancer diagnosis and care, focusing on patient access to oncologic pathology and imaging expertise, and technologies and future directions. Ritu Nayar, MD, Professor and Vice Chair of Pathology, Northwestern University, Feinberg School of Medicine and Trustee of the American Board of Pathology, presented a brief overview on the perspectives of American Board of Pathology, including strategies to develop a workforce for high-quality oncologic diagnosis and care.

ABP’s New-In-Practice survey, done in collaboration with major pathology organizations following the multi-society pathology workforce summit in 2013, is an initiative to determine how pathology residency training and initial ABP certification align with the knowledge and skills required in real-world practice. For most practice areas, residency training was considered “about right” by the respondents. However, five areas that showed a need for realignment include molecular diagnostics, pathology informatics, laboratory administration, medical coding and billing and dermatopathology. Dr. Nayar also mentioned ABP’s participation in, and support to pilot Entrustable Professional Activities (EPA) in pathology training, another step toward a more competency-based education system. Previously, ASCP, the United States and Canadian Academy of Pathology (USCAP) and the ABP had released a joint statement on the value of Maintenance of Certification (MOC). Continuous certification should be relevant and of value to the diplomate- an “assessment of learning, for learning.” Toward that end, ABP recently completed a soft launch of the ABPath CertlinkTM pilot. This will now go into a hard launch in July, 2018 and offer diplomates a longitudinal assessment, focused on practice relevant content, with immediate feedback and resources. In the future, after assessment of this three- to five-year pilot, ABPathCertlinkTM may serve as an alternative to the current MOC Part III 10-year examination.

Talking about improving education and training of pathologists involved in cancer diagnosis, for practice in either academic and community settings, Dr. Nayar stressed the importance of use of synoptic reporting, integration of ancillary studies, clear, timely and concise communication, an interdisciplinary team approach and quality assurance activities to improve diagnostic accuracy and decrease error. Further use and integration of digital pathology and bioinformatics will make expert consultation easier.




CDC ADAPTING GUIDELINES FOR THE DIGITAL AGE MEETING

ASCP was honored to be invited to participate in a new live meeting initiative that took place at the Centers for Disease Control and Prevention (CDC) headquarters in Atlanta for one week in February. This meeting Adapting Clinical Guidelines for the Digital Age is an ongoing CDC initiative centered on improving patient care and health outcomes by working to ensure that clinical guidelines are not just evidence-based, but are used in practice. The initiative focuses on reducing barriers to development and use of clinical guidelines, including concerns that clinical guidelines are:

  • Too slow: Scientific information can take an average of 17 years to apply in patient care. That information lag is a challenge, especially in the case of emergencies or outbreaks.
  • Too difficult to transmit and translate: In order to make guidelines easier for clinicians to use at point of care, they are often transmitted through Clinical Decision Support (CDS) systems, and a resulting “game of telephone” can result in the complexities and nuances being lost.
  • Too disconnected from patient care: Review of new guidelines and updates takes clinicians away from valuable clinical practice time because of their length, complexity and inability to fit into existing patient care workflow.

Stakeholder organizations engaged with CDC personnel in didactic and interactive sessions focused on process improvement using the Kaizen method of continuous process improvement with focus on areas of communication, translation and clinical support tools, as well as more nimble and rapid development. Communications with the CDC will be ongoing to produce tangible improvements in the clinical guideline development, and ASCP is committed to engaging in this process.



For more information regarding ASCP's advocacy initiatives and policy positions, please contact ASCP's Center for Public Policy at (202-347-4450).


  ASCP ePolicy News is supported by
  an unrestricted grant from Hologic.

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