STATLINE

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In This Issue:

• CAP Expects Release of Major Medicare Regulations Over Next Several Weeks
• Pathologists to Engage With FDA at Meeting on Liquid Biopsies
• Editor's Note to STATLINE Readers

New regulations affecting payment for pathology and clinical laboratory services are currently under the review of the White House Office for Management and Budget (OMB), which is a final step before rules are published. The CAP is watching for these rules, and will notify CAP members and provide an initial analysis once the rules are published.

The rules at OMB that the CAP are currently monitoring include:

• Medicare Clinical Diagnostic Laboratory Test Payment System. The Centers for Medicare & Medicaid Services (CMS) will finalize a regulation that revamps the clinical laboratory fee schedule (CLFS) as mandated by the Protecting Access to Medicare Act (PAMA) of 2014. Since 2014, the CAP has engaged with the CMS on its implementation of PAMA and reforms to the CLFS. In September 2015, the CMS released its proposed PAMA rule to detail requirements for applicable laboratories to collect and report private payer rates for clinical laboratory services. The data would be used to calculate Medicare reimbursements for clinical laboratory services. The CAP submitted its formal comments in a November 24 comment letter. In its comments, the CAP expressed concern about the limited scope of the entities required to submit data and on which market rates, as well as the reporting requirements overall.
• Proposed 2017 Medicare Physician Fee Schedule. The proposal is expected to be published in July. Under a new requirement, the CMS will provide additional detail on its intention to revalue certain pathology services targeted as potentially misvalued. The CAP will review proposed changes and provide an impact table showing how the rule affects Medicare reimbursement for pathology services. The CAP also will provide comment and engage with the CMS on the issues impacting pathology. The final version of the rule is expected in early November and will affect reimbursement rates for physician services provided to Medicare beneficiaries in 2017.

In Case You Missed It: MACRA Proposed Rule

The CMS published the proposed regulation implementing Medicare payment reform under the 2015 Medicare Access and CHIP Reauthorization Act (MACRA) on April 27. The Merit-based Incentive Payment System (MIPS) program under MACRA is expected to have a $1.5 billion impact on Medicare payments to pathologists beginning in 2019.

The CAP is engaged on behalf of pathologists on the proposed regulation and is providing comments to the CMS.

MIPS will combine the current Medicare quality programs—the Physician Quality Reporting System, Electronic Health Record Meaningful Use, the Value-Based Modifier—as well as a new performance category termed "Clinical Practice Improvement Activities." The CAP is working to ensure pathologists can comply with MIPS, which is the default pathway under MACRA, when the program starts impacting Medicare reimbursements in 2019. The CMS has proposed to use the 2017 calendar year as its first year for measurement for MIPS.

MIPS payment adjustments, which are based on scores in the system's performance categories, range from +/- 4% starting in 2019 to +/- 9% in 2022 and beyond. A MIPS eligible clinician would receive no payment adjustment if the score is at the performance threshold, a negative adjustment if the score is below the performance threshold, and a positive adjustment if the score is above the performance threshold.

Physicians participating in eligible alternative payment models (APMs) are not subject to MIPS requirements and will receive a 5% bonus from 2019-2024.

Read more about the MACRA proposed rule.

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The CAP will provide a statement during a Food and Drug Administration (FDA) public workshop titled "Liquid Biopsies in Oncology Drug and Device Development" on July 19.

The FDA and American Association for Cancer Research (AACR) are cosponsoring the workshop to discuss liquid biopsies. With liquid biopsy technologies advancing quickly, some tests are being incorporated into drug development programs and are likely to be included in clinical care, an FDA announcement about the workshop said.

The workshop will provide a forum to discuss relevant scientific advances in the field of liquid biopsies in oncology and a regulatory environment that will support rapid translation of this emerging technology into improved patient care.

The workshop aims to:

• Provide a state of the science overview of liquid biopsies in oncology
• Discuss the use of tumor-derived cfDNA in drug development and clinical use, focusing on the treatment of lung cancer as a case study
• Discuss current approaches to validation of in vitro diagnostic devices (or tests)
• Discuss with diverse stakeholders ways to accelerate development of these technologies to advance cancer care

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Due to the Memorial Day holiday, the CAP's weekly edition of STATLINE is taking a scheduled break on May 31. The next regular edition of STATLINE will be published on June 7. If major news breaks before June 7, CAP members will receive a STATLINE Special Report with news also published on the CAP's Twitter and Facebook feeds.

Please email STATLINE's editor if you have questions or comments.

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