Read the Latest Issue of STATLINE

More than 115 CAP members travelled to Washington, DC, to advocate for the pathology specialty and their patients during the 2016 CAP Policy Meeting May 2-4. During the meeting, pathologists engage with health care policymakers and congressional offices to address regulatory and legislative challenges facing the specialty.

The CAP Council on Government and Professional Affairs (CGPA) Chair Emily E. Volk, MD, FCAP, opened the meeting on May 2 by reviewing these challenges, which include implementation of payment reforms under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), Medicare local coverage determinations (LCDs), and the oversight of laboratory-developed tests. Dr. Volk discussed in detail what the CAP is doing to address these challenges.

Since 2012, CAP members have participated in 582 meetings with congressional offices and achieved several victories. For example, physicians successfully advocated for the repeal of the sustainable growth rate (SGR). CAP members also have successfully avoided Medicare payment penalties from the Electronic Health Record (EHR) Meaningful Use program after engaging with members of Congress at previous Policy Meetings and through the CAP's grassroots network PathNET.

"This process works and this advocacy structure has been effective," Dr. Volk said.

CAP to Engage With Lawmakers on LCD Reform

The LCD process continues to be a concern for pathologists and is in need of reform. The CAP, for example, is calling for coverage decisions to be made by qualified health experts through a transparent process based on sound medical evidence.

CAP Economic Affairs Chair Jonathan L. Myles MD, FCAP, led a panel discussion on the evolving Medicare and private sector coverage landscape. Dr. Myles was joined by Mandy K. Cohen, MD, MPH, chief operating officer and chief of staff at the CMS, and John Yao, MD, MPH, MBA, the staff vice president of medical policy at the health insurer Anthem, Inc.

On May 4, 87 CAP members will visit congressional offices to advocate for needed LCD reform. They will spend the day in Senate and House offices explaining the need to reform an LCD process that lacks openness and transparency.

New MACRA, PAMA Regulation

Following the recent release of the proposed rule to implement MACRA, CAP leaders and policymakers in Washington discussed the impact of the new reforms to the Medicare program and the pathology specialty. Diana M. Cardona, MD, FCAP, the chair of the CAP Economic Affairs Measures and Performance Subcommittee, led a panel discussion on MACRA. Dr. Cardona was joined by CMS Medical Officer Lemeneh Tefera, MD, and Robert A. Berenson, MD, a fellow at the Urban Institute.

Dr. Cardona reviewed how the MACRA rule will apply to pathologists and the concerns pathologists have with implementation of the new programs. The proposed MACRA rule detailed how new payment pathways, the MIPS and APMs, will set performance thresholds and affect payment for physician services. For the 2019 payment year, the CAP is working to ensure pathologists can comply with MIPS, which is the default pathway under MACRA. The CMS proposes to use the 2017 calendar year as its first year for measurement for MIPS.

The CAP continues to analyze the proposed MACRA rule and will provide comment on APM and MIPS provisions, Dr. Cardona said. The CAP is also assessing the feasibility of options under MACRA, such as the new physician-focused payment model, for pathologists. The CAP will continue to educate pathologists about implementation of MACRA through STATLINE, webinars, and other platforms.

In MIPS, an eligible clinician would receive no payment adjustment if his or her performance 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. The payment adjustments range from +/- 4% starting in 2019 to +/- 9% in 2022 and beyond. Physicians participating in eligible APMs receive a 5% bonus from 2019–2024 and are not subject to MIPS requirements.

Policy Meeting Keynote Speaker Harold Miller, who is president and CEO of the Center for Healthcare Quality and Payment Reform, highlighted initiatives from across the country that have been successful in payment reform implementation efforts. Miller spoke about effective strategies as well as common obstacles faced by payment and delivery system reform efforts. He encouraged pathologists to design their own APMs. He outlined four steps to successful models designed by physicians:

  • Evaluate the opportunities to improve care and control costs
  • Evaluate barriers in the current payment system
  • Determine changes in payment to improve care
  • Evaluate how physicians will take accountability for results

The CAP is currently assessing the feasibility of specific alternative payment models for pathology.

CAP members received important information about Protecting Access to Medicare Act of 2014 (PAMA) law, which requires the CMS to substantially overhaul the Medicare clinical laboratory fee schedule (CLFS) payments. PAMA also requires collecting data from "applicable laboratories" on payments received from private payers for clinical laboratory services and basing CLFS payments on the weighted median of this information in 2017. Those laboratories subject to the reporting requirement could face significant monetary penalties for non-compliance.

CAP Past President Stephen N. Bauer, MD, FCAP, led a panel discussion with Marc Hartstein, director of the CMS Hospital and Ambulatory Policy Group, and Paul W. Radensky, MD, JD, a partner at the law firm McDermott Will & Emory. The CMS published a proposed PAMA regulation in 2015. The final rule is currently being reviewed by the Office of Budget and Management and is expected to be published within the next couple weeks.

Look for more coverage of the 2016 Policy Meeting in the next issue of STATLINE.

Back to the top

Clinical laboratory advisory boards that help ensure patient access to medically necessary diagnostic testing will now be required for accountable care organizations (ACOs) in Tennessee following the enactment of legislation supported by the CAP and Tennessee Society of Pathologists (TSP).

Tennessee Gov. Bill Haslam signed the CAP-model ACO legislation into law on April 27 following unanimous passage by the Tennessee General Assembly. The new law (HB 1100/S 851) will require an ACO to establish an advisory board to consider and recommend guidelines or protocols for clinical laboratory testing. An advisory board will have at least one physician who is a clinical laboratory director. Similar laws promoting pathologist integration as a clinical advisor role within ACOs have been adopted in Massachusetts and Illinois.

The CAP and TSP strongly advocated for the legislation. Prior to Gov. Haslam signing the bill, CAP President Richard C. Friedberg, MD, PhD, FCAP, sent a letter detailing several reasons in support of enactment.

"The CAP believes that every Accountable Care Organization (ACO) will need to effectively use clinical laboratory/pathology tests to achieve their public policy mandate for control of healthcare costs and improvement of patient outcomes," the letter said. "Clinical laboratory tests now drive more than 70% of medical decision-making. Furthermore, advances in genomic medicine and predictive diagnostic technology will increase the critical use of laboratory testing to enhance patient outcomes, especially for those patients with cancer."

At a March 15 Tennessee House Health Subcommittee hearing, Kathryn T. Knight, MD, FCAP, on behalf of the TSP, provided testimony in support of the bill. Dr. Knight, who is Vice Speaker for the CAP House of Delegates and practices in Nashville, stated the legislation would require advisory boards to make recommendations to ACO governance boards for guidelines or protocol adoption for laboratory testing and ensure appropriate use of testing.

"As legislators you can set ACOs on the right path. We, as pathologists within ACOs, recognize that we have to participate in that journey," Dr. Knight said. "If this legislation is enacted, I believe all physicians will be able to do their part and together we can achieve the best quality in patient care."

In addition to the CAP and TSP's support, the Association of Pathology Chairs and the Association for Molecular Pathology have endorsed the legislation. The following national patient advocacy groups also have endorsed the legislation: the Leukemia and Lymphoma Society, National Brain Tumor Society, Lung Cancer Alliance, and the American Society of Breast Disease.

Back to the top

The CMS declined to adopt standards to promote health plan network adequacy and ensure access to in-network physician specialists at in-network facilities and hospitals in a final regulation addressing Medicaid Managed Care and Children's Health Insurance Program (CHIP) coverage on April 25. The CMS further responded that states should define network adequacy standards.

The CAP and a coalition of hospital-based physicians had stated their concerns over the process of setting adequate insurance network standards and advocated for changes. In a July 2015 letter to the CMS, the coalition recommended additional criteria be set in the section on "Availability of services, Assurances of Adequate Capacity and Services, and Network Adequacy Standards." The letter was signed by the CAP, American College of Radiology, American Society of Anesthesiology, and Society of Hospital Medicine.

The CAP and physician groups believe the CMS should establish a paragon standard to promote a robust in-network provision of physician services at in-network hospitals and facilities regardless of governmental or non-governmental coverage. Doing so will protect patients, minimizing their costs for health care services in the commercial insurance market and in the state and federally sponsored health plan exchanges.

"We decline to list additional provider types and categories as commenters recommended," the CMS stated. "We believe that the proposed list strikes a balance of ensuring access to care and state flexibility. States have the authority to add additional provider types to their network adequacy standards to reflect the intricacies of their Medicaid programs."

In response to comments recommending hospital-based specialists be added to network adequacy standards, the CMS stated it would be inappropriate for such standards to be set at the federal level.

"We also believe that states are in the best position to engage a variety of stakeholders when defining the 'specialist' category and setting appropriate network adequacy standards for such defined 'specialist' providers," the CMS stated. "We specifically encourage states to be transparent in this process."

Back to the top