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April 16, 2019

In This Issue:

As part of legislation enacted in 2018 to address the opioid crisis, Congress included the Eliminating Kickbacks in Recovery Act (EKRA) in the final bill late in the legislative process. As it’s now law, EKRA authorized criminal penalties for laboratories that pay sales commissions to employees. The new law applies to laboratories that serve all payers, not just Medicare.

The CAP was engaged on the opioid legislation, including adding a provision to allow autopsy report data to be collected by the Centers for Disease Control and Prevention, but the EKRA language was added to the bill at the last minute with little transparency adding to concerns that EKRA was not properly vetted and may have unintended consequences.

EKRA, which falls under the jurisdiction of the Department of Justice (DOJ), amended the criminal code to make it a crime to solicit, receive, pay, or offer payment for referrals to laboratories. The CAP will engage with the DOJ to seek clarification and/or guidance regarding compliance with the statute. Moreover, the CAP has and will further engage with other stakeholders to ensure the concerns of pathologists and laboratories are addressed.

EKRA initially intended to target providers of substance abuse services. However, the definition used for laboratories in the statute does not specifically target those providing substance abuse services. Potential criminal conduct may include:

  • Donating of free testing services and/or testing supplies that could be considered paying or offering in-kind renumeration.
  • Paying an administrative fee to a group purchasing organization for recommending or arranging for the provision of laboratory services to the organization’s members.
  • Providing a phlebotomist to a physician office to draw blood specimens being sent to the laboratory.

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Reps. Jackie Speier (D-CA) and Dina Titus (D-NV) introduced legislation, supported by the CAP, that would close Medicare’s self-referral loophole on April 9. The newly reintroduced Promoting Integrity in Medicare Act (PIMA) would prevent physicians in certain specialties from referring patients to ancillary medical services in which they have an ownership interest and are offered in their offices.

Closing the loophole would save an estimated $3.3 billion, according to a 2017 analysis conducted by the nonpartisan Congressional Budget Office (CBO). The CAP has advocated for closing the loophole and passing other laws that protect pathologists’ ability to provide high-quality services in a fair competitive environment, by requiring direct billing of pathology services or prohibiting markups of services.

Several studies provide evidence and show overutilization of services and increased costs under the in-office ancillary services (IOAS) exception loophole to the current Stark self-referral law. The exception has fostered over-ordering of anatomic pathology services by self-referring physicians to maximize profits. The IOAS exception was intended to afford patient convenience yet anatomic pathology services are rarely ever done at the time of an office visit.

The new legislation would ensure that incentives driving medical decisions would be based solely on patients’ best interests, thereby reducing unnecessary and inappropriate services and costs to Medicare. The bill is supported by the Alliance for Integrity in Medicare, which includes the CAP, American Clinical Laboratory Association, American Physical Therapy Association, Association for Quality Imaging, American Society for Radiation Oncology, American Society for Clinical Pathology, and Private Practice Section of the American Physical Therapy Association.

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A former official from the Centers for Medicare & Medicaid Services (CMS) will join CAP leaders for a discussion on the Protecting Access to Medicare Act of 2014 (PAMA) during the 2019 Policy Meeting April 29-May 1.

PAMA was designed to develop an accurate, market-based payment system for laboratories paid through the Clinical Laboratory Fee Schedule (CLFS). However, the data collected thus far does not accurately reflect all sectors of the clinical laboratory market.

During an exclusive panel discussion at the 2019 Policy Meeting, experts will review the current PAMA scope, the reporting burden that the requirements have on laboratories, and discuss the improvements needed to ensure that the data collected by the CMS accurately reflect all sectors of the clinical laboratory market. The panel will include W. Stephen Black-Schaffer, MD, FCAP, the chair of the CAP Economic Affairs Committee; and Marc Hartstein, a former CMS official who is now a principal at Health Policy Alternatives. The panel will review what pathologists need to understand about PAMA data collection and discuss the importance of validating data. Donald S. Karcher, MD, FCAP, the chair of the Council on Government and Professional Affairs, will moderate this important discussion.

There is still time to register for the 2019 Policy Meeting April 29-May 1 in Washington, DC. In addition to unique opportunities to hear from leaders and newsmakers in US politics, the 2019 Policy Meeting is your chance to speak directly to members of Congress and their staff during the CAP’s annual Hill Day on May 1. The Policy Meeting is the pathologist’s opportunity to educate legislators and policy experts on the value that pathology brings to the health care continuum.

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The Food & Drug Administration (FDA) announced on April 2 steps to consider a new regulatory framework to promote the development of safe and effective medical devices that use advanced artificial intelligence (AI). The CAP remains actively engaged with the FDA on artificial intelligence issues related to diagnostic medicine and new innovative regulatory parameters.

The FDA released a discussion paper on artificial intelligence on April 2. The CAP is reviewing the discussion paper and plans to comment on parameters as it applies to the practice of pathology. The CAP will provide its feedback by June 3. The FDA would then issue draft guidance that incorporates feedback that the agency receives.

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To ensure safe testing for patients and minimize burdens on laboratories, the CAP engaged with three federal workgroups concerning oversight of clinical laboratory testing during a meeting on April 10.

At the Clinical Laboratory Improvement Advisory Committee (CLIAC) April meeting, the CAP provided its comments for workgroup summary reports on next-generation sequencing (NGS), CLIA personnel regulations, and a nontraditional testing workflow model. As an advisory committee, CLIAC offers recommendations and guidance to federal oversight agencies to improve clinical laboratory quality and laboratory medicine practice.

Previously, CLIAC also recommended the development of a workgroup to address nontraditional testing models. The workgroup would provide input regarding the need for optimal oversight by CLIA and best methods for oversight in nontraditional testing, such as telemedicine, bioinformatics, and NGS. Regarding nontraditional testing workforce model, the CAP recommended additional input from stakeholder is needed to ensure regulatory oversight is not overly burdensome to clinical laboratories. The CAP will further engage with CLIAC on the workflow model.

In addition, CLIAC had recommended the formation of a separate NGS workgroup to develop recommendations and prioritize regulatory gaps for assuring the quality of NGS in clinical laboratory setting. To ensure the accuracy and reliability of NGS testing, the CAP said CLIAC should prioritize three areas: bioinformatics, quality control and assurance, and personnel competency.

The CAP also engaged on CLIA personnel regulations and requirements contained in a summary report. The CAP advocated for more engagement with stakeholders to appropriately update CLIA personnel requirements and address advancing or emerging technology while not exacerbating the clinical laboratory testing personnel shortages. The CAP proposed that CLIAC focus on personnel requirements for point-of-care testing, allowance of supervisors to perform competency assessments of moderate- and high-complexity personnel, retaining current level of experience and training required to determine potential personnel eligibility, and consideration of physical and non-traditional degrees that include human biology coursework, with robust personnel experience and training requirements to ensure these individuals have enough knowledge base to perform clinical laboratory testing.

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The CMS will host a webinar on April 18 to review requirements for the facility-based measurement for the 2019 Merit-based Incentive Payment System (MIPS) reporting. In 2019, the CMS will automatically assign scores for the Quality and Cost categories of MIPS based on the Hospital Value Based Purchasing (VBP) program to those clinicians defined as facility-based.

The CMS defined facility-based MIPS eligible clinicians as those who furnish 75% or more of their covered professional services in sites identified with place of service (POS) codes 21 (inpatient hospital), 22 (on campus outpatient hospital), or 23 (emergency room). In addition, clinicians must have at least one service billed with POS 21 or 23 (inpatient or emergency room).

The CMS is making available a facility-based preview which is based on earlier data from the Hospital VBP and should give an idea of what facility-based scores for the Quality and Cost performance categories may resemble. For pathologists eligible for facility-based measurement, the preview period will enable them to determine if additional Quality data submission is necessary.

If interested, register for the webinar to secure your spot:

Title: Facility-based Preview Live Demo and Office Hours Session
Date: Thursday, April 18, 2019
Time: 1:00 PM ET

You can check your facility-based status on the CMS Quality Payment Program participation look-up tool. A facility-based clinician is attributed to the hospital at which he or she provides services to the most Medicare patients, which will also be indicated on the CMS’s look-up tool. The CMS also has released a 2019 Facility-based measurement fact sheet and the facility-based preview FAQs.

As always, the CAP has MIPS experts available to answer your reporting and data questions. Please email for answers to your MIPS questions.

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