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The CAP applauded the Centers for Medicare & Medicaid Services (CMS) for revising its National Coverage Determination (NCD) on Next Generation Sequencing (NGS) after addressing several issues raised by pathologists.

On March 16, the CMS finalized the NGS NCD after making substantial changes from what was originally proposed in November of last year. Citing several negative impacts to cancer patients, the CAP had opposed the CMS’ draft NCD and advocated for several changes. Those changes were detailed in a January 17, 2018, letter.

“The implementation of the draft NCD criteria for NGS would have had profound adverse and immediate consequences for Medicare beneficiary access to therapies, and negatively impact the treating physician's ability to order medically necessary tests for patients," said CAP President R. Bruce Williams, MD, FCAP. "While the final NCD nationally covers only approved U.S Food and Drug Administration-cleared tests using NGS, the final determination leaves the local Medicare Administrative Contractor with the discretion to cover all other tests as long as specific patient criteria are met. The expanded criteria include recurrent, relapsed, refractory, metastatic, and advanced stage III or stage IV of cancer.”

Key provisions from the CMS decision include:

  • Any diagnostic laboratory test using NGS that is approved or cleared by the Food and Drug Administration (FDA) as a companion diagnostic for any patient that meets the patient criteria recurrent, relapsed, refractory, metastatic, and advanced stages III or IV cancer will be covered nationally under this NCD. The inclusion of stage III cancer represents expansion of coverage in the final NCD.
  • Coverage determinations for any other diagnostic laboratory test using NGS for these same patients would be made by Medicare contractors. Therefore, the final determination leaves the local Medicare Administrative Contractor (MAC) with the discretion to cover all other tests as long as specific patient criteria are met. All NGS tests for patients that meet the patient criteria are left to contractor discretion.
  • The CMS removed coverage with evidence development (CED) requirements in the final NCD. Commenters reported that they are already developing or have developed the evidence to demonstrate that diagnostic laboratory tests using NGS improve health outcomes for Medicare beneficiaries with cancer— or are equipped to conduct their own studies to generate evidence.

The CAP continues to work with the CMS on this matter.

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The CAP continues to engage with the CMS on its Merit Based Incentive Payment System (MIPS) strategy in order to advocate for pathologists’ successful participation in the quality payment program as non-patient facing clinicians. Currently, pathologists are exempt from reporting in the Advancing Care Information and Cost categories of MIPS and are only scored in the Quality and Improvement Activities categories.

The CAP met with the CMS to discuss ways for pathologists to be successful in reporting MIPS, such as:

  • Maximizing scoring points through quality reporting,
  • Creating easier pathways for pathologists to participate in and attest to quality improvement activities,
  • Developing new ways for pathologists to participate in MIPS’s advancing care information category, and
  • Ensuring that pathologists are viewed fairly in measurements that evaluate cost.

Through its continued dialogue with the CMS, the CAP hopes that pathologists can successfully participate in the Medicare Quality Payment Program with less reporting burdens.

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The Connecticut Society of Pathologists (CSP), with the support of the CAP, is seeking to modify legislation backed by the Connecticut Governor that would expand the current law banning balance billing in the hospital setting to all out-of-network (OON) clinical laboratory services referred by in-network physicians.

Under current law, balance billing is prohibited for all hospital-based OON laboratory services. Under that measure, effective since 2016, payment for hospital-based OON services is set at in-network rates, while emergency medicine is paid at the 80th percentile of the FAIR Health charge database. The Fair Health charge database is a substantially favorable payment standard for physicians .The CAP and the CSP have long been fighting for parity in payment for pathology services, as part of coalition of hospital–based specialties seeking parity with emergency medicine payment as well. Last year the coalition effort to secure parity in payment was blocked in the state legislature and was opposed by the Department of Insurance.

This year’s legislation, SB 210 would amend the statutory definition of “surprise billing” to include certain laboratory services. The CSP, however, notes that there are instances where patients might voluntary select an OON laboratory and thus the bill they receive would not be a “surprise.”

“There are two highly feasible reasons patients would select an out-of-network pathology provider,” the CSP says in written testimony. “Patients may need to select an OON provider for specialized pathology testing on a specimen which is not provided in-network, or patients may select an OON provider to secure a pathology second opinion on a specimen.”

In addition, patients who are under anesthesia for a procedure or otherwise incapacitated cannot voluntary select an OON laboratory provider, the CSP adds. These OON pathology services must be performed under routine and urgent standards of care by the OON provider. Accordingly, because of the urgent and immediate nature of the pathology services rendered, such services should be designated “emergency services.” The current definition of emergency services does not include such laboratory and pathology services.

The CSP is urging that SB 210 be amended to exempt OON laboratory services voluntarily selected by the patient and to designate urgently needed pathology and laboratory services provided when the patient is incapacitated as “emergency services.”

STATLINE will continue to follow development on this legislation.

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The CMS wants to learn more about reporting issues and burdens that practices have encountered with MIPS. As part of our MIPS advocacy for pathologists, the CAP continues to ask the CMS to reduce the administrative burden of MIPS reporting. The CMS has responded by asking physicians directly for their feedback. This is the last week to submit applications, as the deadline closes Thursday, March 23, 2018.

Currently the CMS is reviewing the Burdens Associated with Reporting Quality Measures in 2018 study, as outlined in the 2018 Quality Payment Program final regulation. The CMS study will run from April 2018 to March 2019.

In the study, the CMS would like to learn about:

  • Clinical workflows and data collection methods using different submission systems when reporting on MIPS
  • Understand any challenges you have when you collect and report quality data
  • Recommend any changes that would lower your burden, improve quality data collection and reporting, and enhance clinical care

If you are a MIPS eligible pathologist, you can report and participate in this study and may be eligible for a 2018 MIPS Improvement Activities performance category credit. The CMS will consider a limited number of clinicians who are not eligible for MIPS in 2018. To check your MIPS participation status go to HTTPS://QPP.CMS.GOV/.

In order to complete the study and earn full improvement activity credit, you’ll need to do the all of the following:

  • Complete a 2017 MIPS participation survey in April/May 2018.
  • Complete a 2017 MIPS participation survey in April/May 2018.
  • If invited by the study team, you must join a virtual 90-minute focus group between November 2018 and February 2019.
  • You must meet minimum requirements for the MIPS quality performance category by submitting data for at least three measures in the MIPS quality performance category, as required for 2018 MIPS participation. The data submitted must:
    • Include one outcome measure.
    • Be submitted by the March 31, 2019, final MIPS reporting deadline.
    • Be submitted through any method accepted under 2018 MIPS Quality Payment Program.

If you report as a group, your entire group will earn credit. If you report as individuals, only you will earn credit.

You can begin your application here, as the last day to submit applications is March 23, 2018.

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Donald Karcher, MD, FCAP

Wednesday, April 4, 2018 1:00 PM ET/ Noon CT

If you are one of the many pathologists concerned about practice or patient care implications from emerging policies and regulations, join us in this 60-minute webinar to learn the most effective ways you can ensure your voice is heard in Washington on issues that matter to you.

Gain insight on best practices and understand the difference you can make by engaging with your colleagues in protecting scope of practice and the quality of care for patients.

Joe Saad, MD, FCAP

Already registered to attend this year’s Policy Meeting? This is a great webinar for CAP members who are attending the Policy Meeting, especially those attending for the first time, as you’ll gain a general understanding of grassroots advocacy before you arrive in Washington.

Whether you are DC bound or looking to get involved in your district, you’ll want to hear from experienced advocates Donald Karcher, MD, FCAP, Chair of the Committee of Government and Professional Affairs, Joe Saad, MD, FCAP, Federal and State Affairs Committee Chair, and moderator Michael Giuliani, CAP Advocacy Senior Director.

Register Today.

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