ePolicy News January 2018

Jan 11, 2018
Read the latest ASCP policy news from Washington, DC.

CMS Grants ASCP’s National Pathology Quality Registry QDCR Status

ASCP is pleased to announce that its National Pathology Quality Registry (NPQR) has been granted Qualified Clinical Data Registry (QCDR) status for 2018 by the Centers for Medicare and Medicaid Services (CMS). With QCDR status, NPQR offers pathologists a way to meet 2018 requirements under CMS’ Merit-based Incentive Payment System (MIPS) so that they can not only avoid penalties, but potentially gain positive payment adjustments.

NPQR, established by ASCP in 2016, offers a wide variety of meaningful, patient-centric measures – a subset of which is designated for MIPS reporting through the QCDR. The measures currently focus on the following topics, and additional topics will be added in the future:

  • Monitoring appropriate utilization of laboratory testing.
  • Improving pre-analytical processes.
  • Optimizing turnaround time and critical value reporting.
  • Assessing analytical and diagnostic accuracy.

“ASCP recognizes the heterogeneity in pathology practices and listened to our members’ feedback on how existing measures suited only a subset of pathologists,” said Ali Brown, MD, FASCP, Medical Director of NPQR. “With these challenges in mind, ASCP developed NPQR to have applicable measures for most labs, with topics suiting both anatomic and clinical pathology.” To learn more about ASCP’s QCDR, click here.

ASCP Applauds ACLA Lawsuit against CMS

On December 11, the American Clinical Laboratory Association filed a lawsuit against CMS, arguing that the federal agency did not fulfill its statutory obligations when it announced new payment rates for the Clinical Laboratory Fee Schedule (CLFS) for 2018. The new payment rates were mandated by the Protecting Access to Medicare Act of 2014 (PAMA). PAMA requires CMS to implement a market-based payment system for all laboratory tests reimbursed under the CLFS. CMS, however, ignored price and volume data from more than 99 percent of clinical laboratories. The ACLA lawsuit argues that by ignoring data from the vast majority of laboratories, it failed to adhere to statutory obligations—resulting in a deeply flawed payment scheme. ASCP has repeatedly voiced these concerns to CMS and congressional policymakers and argued that the new payment rates significantly undervalue laboratory services and threatens patient access to testing services. ASCP last month urged CMS to suspend its new payment rate system until it can address concerns with the effort. ASCP applauds ACLA for its initiative and will continue to work with the Association and others in the laboratory community to address flaws with the CMS revaluation of the CLFS.

CMS Releases CLIA Information Request on Personnel, Other Standards

On Jan. 8, the Centers for Medicare and Medicaid (CMS) released a Notice of Information Request seeking comments on the Clinical Laboratory Improvement Amendments of 1988 (CLIA) personnel requirements. Of note, the proposal outlines the Agency is considering provisions to the CLIA regulations that would allow an individual with a bachelor’s degree in nursing to perform moderate and high complexity testing and serve as a technical consultant for moderate complexity laboratories. In 2016, the BOC and ASCP objected to a CMS interpretation that nursing and biological sciences degrees are the same thing for the purposes of performing high complexity testing. ASCP is currently reviewing the CMS Information Request and will submit formal comments on the proposed policy. Individuals wishing to comment on the proposal can use the link above to do so.  Comments are due by March 12.

ASCP Advocates for Pathologists in Quality Payment Program Final Rule Comments

In a recent comment letter to CMS regarding the Quality Payment Program (QPP) Program Year 2018 Final Rule, ASCP continued to advocate for substantive participation for pathologists. For example, ASCP urged that CMS provide:

  • Continued flexibilities for pathologists included in the transition year;
  • Reduced burden on small practices through Virtual Group implementation;
  • Continued reporting through QCDRs such as the NPQR to encourage participation in the QPP; and
  • Increased applicability of the program for pathology and laboratory medicine

ASCP will continue to advocate on behalf of pathologists to ensure meaningful participation in Medicare payment programs as they continue to evolve.

FREE MIPS Reporting Option for 2017

It’s not too late to participate in 2017 MIPS reporting!  ASCP is offering a FREE and easy 2017 reporting option for pathologists who wish to avoid the 4% payment penalty. Please see here for more information; the submission deadline is Jan. 24, 2018. The NPQR will also be offering reporting options for the 2018 year as a CMS QCDR to help pathologists not only fulfill MIPS requirements, but potentially earn bonuses on their Medicare payments.

MedPAC Recommends Repealing the MIPS Portion of the QPP

On Jan. 11, the Medicare Payment Advisory Commission (MedPAC) voted 12-4 to repeal and replace the Merit-based Incentive Payment System (MIPS) in favor of a voluntary, value-based approach. The Commission wants to repeal MIPS because they believe it is too burdensome for physicians and doesn’t provide meaningful quality improvement. They further criticized the program for focusing on process and not measuring patient outcomes.

The physician community, however, is at odds with proposal as many are still adjusting to the MIPS program and outcomes of the new program have yet to be measured. Additionally, the new program MedPAC proposed may not be meaningful for pathologists as it involves a monetary withhold that can only be gained back by voluntarily joining a group of other clinicians (which wouldn’t necessarily measure individual performance) or join an Advanced Alternative Payment Model (which has not been a viable option for pathologists in the past as it involves taking on significant financial risk for patients they have little control over).

ASCP will track this development and report on its impacts as they arise.

ASCP Requests Changes to CMS DOS Policy

ASCP submitted formal comments last month on the Medicare Outpatient Prospective Payment System Final Rule. ASCP thanked the Agency for adopting ASCP’s policy recommendation to revise the Agency’s Date of Service (DOS) policy, which requires hospitals to bill for laboratory tests ordered within two weeks of a patient discharge. CMS announced in its Final Rule it would allow an exception to the rule for molecular tests and Advanced Diagnostic Laboratory Tests, both of which were supported by ASCP, ordered on patients within 14 days of an outpatient discharge. In its comments on the Final Rule, ASCP urged that CMS extend the exception to other laboratory services, such as Multianalyte Assays with Algorithmic Analyses and that the Agency also extend the exception to inpatients. ASCP also thanked the Agency for extending the exception to liquid specimens, where not included as part of the Proposed Rule. Click here to obtain a copy of ASCP’s comments on the Final Rule.

Lab Community Wins Extension of Deadline on Proposal NCD

ASCP is pleased to report that CMS has agreed to extend the comment deadline for a proposed National Coverage Determination (NCD) on Next Generation Sequencing for Medicare Beneficiaries with Advanced Cancer. The CMS action came in response to a sign-on letter signed by ASCP and authored by the ACLA. The purpose of the NCD was to provide coverage for the FoundationOne-CDx (F1CDx) next generation sequencing (NGS)-based test. The NCD would impose significant constraints on the future coverage of NGS-based testing and the development of future genomic-based testing. The CMS coverage policy would prevent laboratory developed tests from being reimbursed by Medicare. CMS also outlined burdensome evidentiary requirements, which could require laboratories to participate in clinical trials and have access to patient outcomes data. This latter requirement could pose insurmountable as access to patient outcomes data is difficult for laboratories to access. ASCP, ACLA and other stakeholders, such as the Association of American Medical Colleges, Association for Molecular Pathology, Association for Pathology Chairs, California Clinical Laboratory Association, and College of American Pathologists wrote CMS urging that addition time be granted to enable stakeholders to provide appropriate feedback. ASCP will be submitting formal comments on the NCD in advance of the new January 17 deadline.

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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