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Following opposition from the CAP and other pathology and laboratory organizations, the Department of Veterans Affairs (VA) significantly modified a proposed regulation and struck language that would have granted registered nurses within the VA system full practice authority with regards to laboratory services. Overall, the CAP, the American Medical Association (AMA), and other physician organizations remain concerned with VA's final regulation.

While the regulation does establish a carve out for laboratory, radiology, and anesthesiology services, the AMA stated its disappointment that the VA final rule grants most APRNs authority to practice independently of a physician's clinical oversight regardless of individual state law within their VA employment. The AMA stated "the new APRN policy rewinds the clock to an outdated model of care delivery that is not consistent with the current direction of the health care system."

In the CAP's advocacy with the VA, the College stated its deep concerns with a proposed regulation to allow advanced practice registered nurses (APRNs) to supervise the performance of laboratory tests. The current CLIA Clinical Laboratory Personnel Requirements for General Supervisor requires specific laboratory training in laboratory science or medical laboratory technology and previous training and/or experience in high complexity testing. The CAP stated in a July 25 letter to the VA that nursing education and training are not an equivalent or appropriate substitute for laboratory science education and training and do not adequately prepare individuals for a technical or general supervisor role in a CLIA certified laboratory. The CAP had urged the VA to not proceed with the proposal, released on May 25, as written.

"The CAP is concerned that the proposed rule would allow APRNs with full practice authority to perform and supervise laboratory studies," the CAP said. "APRNs do not have the knowledge, training, and clinical expertise to perform these functions. The field of laboratory medicine is complex from manual procedures to the use of sophisticated automated analytical instruments. Laboratory professionals are trained to make decisions about the validity of data to be used by physicians in medical decisions. This type of analysis requires extensive knowledge of normal and abnormal physiology, correlation of laboratory data to specific disease as well as extensive knowledge of instrumentation and individual test principles."

In the final rule, the VA made other changes sought by the CAP. Regarding diagnostic services, certified nurse practitioners will be limited to ordering laboratory and image studies and can then integrate the diagnostic results into clinical decision making. The proposed rule would have allowed nurses to order, perform, supervise, and interpret laboratory and imaging studies.

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The CAP advocated that the Centers for Medicare & Medicaid Services (CMS) continue to provide pathologists with flexibility as the Medicare program transitions to a new reimbursement system in 2017.

With federal officials working to implement Medicare Access and CHIP Reauthorization Act (MACRA) that reforms how physicians are reimbursed, the CAP has advocated for changes to regulations that implement the Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) initiatives under the CMS' Quality Payment Program. To date, the CAP has been successful in its advocacy efforts on MACRA. The 2017 program year will be a transition period for eligible clinicians.

In a December 19 letter to the CMS, the CAP reemphasized its calls for flexibility and several other changes impacting pathologists. The CAP approved of the CMS’s designation of 2017 as a transition year for MIPS. The CMS states that eligible clinicians (EC) can submit a minimum amount of data in 2017 in order to avoid Medicare penalties in 2019. This provides CAP members an opportunity to familiarize themselves with the rules of the new Quality Payment Program.

In its final MACRA regulation, the CMS designated three of the CAP's quality measures as outcomes measures for pathologists. The CAP recommended the CMS designate four additional measures as outcomes measures in the pathology-specific measure set to be consistent and to avoid confusion among pathologists.

The CAP also sought confirmation that the MIPS payment adjustments will only apply to the physician Part B services. Most pathologists, including those practicing at independent laboratories, will be eligible for the MIPS and must meet program criteria to avoid a negative payment adjustment.

Defining Non-Patient-Facing Physicians

In the final regulation, the CMS changed its threshold for determining whether a physician is a "non-patient-facing eligible clinician." Those physicians with less than 100 patient-facing encounters will meet the non-patient-facing clinician definition. The definition is dependent on the codes that define patient-facing encounters, although the code list has not yet been published. For example, previously the CMS has included CPT codes for Fine-Needle Aspiration (10021 and 10022) as a face-to-face encounter. Instead of setting a threshold, the CAP requested that pathologists (as identified by their Medicare enrollment records) be automatically identified as non-patient-facing ECs at the beginning of each year.

Eligible clinicians who meet the non-patient-facing definition are provided with additional flexibility under MIPS.

With regards to the term non-patient-facing clinician, the CMS asked for input on creating a better term. The CAP prefers the term “clinician-facing” physicians.

Read the CAP's full comment letter to the CMS on MACRA.

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STATLINE will take a scheduled break on December 27. If major news breaks, 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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