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The CAP will collaborate with stakeholders to develop protocols for collection, processing, and analysis of cancer blood samples as part of the Blood Profiling Atlas Pilot project within the national "Cancer Moonshot" initiative.

On October 17, CAP President Richard C. Friedberg, MD, PhD, FCAP, attended the White House event to announce the blood profiling initiative.

Blood profiling measurements are valued by the cancer community because biopsy material can be repeatedly accessed and they allow for easier tracking of the molecular evolution of cancer. Because liquid biopsies are relatively new, questions remain about these assays, and standard protocols have yet to be established. In addition, clinicians are restricted in their ability to perform liquid biopsy analysis in clinical care. The task force is calling for standards to move this research to the forefront.

"Improvement in health care only comes with consistent collaboration. Pathologists know collaboration—we do it every day—and the CAP is the leader in establishing standards in cancer care and research, so we are eager to get to work to improve patient health and to ultimately conquer cancer," said Dr. Friedberg. "Liquid biopsies hold great potential for enormous research and care of cancer, and the CAP is well positioned in these collaborative conversations."

The CAP will be represented by Carolyn Compton, MD, PhD, FCAP, the chair of the organization's Pre-analytics for Precision Medicine Project Team (PPMPT) in upcoming meetings to discuss the Blood Profiling Atlas.

Vice President Joe Biden, who oversees the Moonshot task force, has said that better cancer data sharing will be critical in the group's goal of doubling the rate of progress toward ending cancer as we know it. He's called for the elimination of "silos" in which research tends to be conducted and seldom shared.

During his 2016 State of the Union Address, President Obama called on Vice President Biden to lead a new, national Cancer Moonshot, focused on making a decade's worth of progress in preventing, diagnosing, and treating cancer in five years—ultimately striving to end cancer as we know it. After meeting with experts across the country and the world, Vice President Biden identified areas of focus for the Cancer Moonshot—based on barriers to progress and opportunities for improving patient outcomes—and announced a first wave of accomplishments at the Cancer Moonshot Summit on June 29, 2016 at Howard University in Washington, DC.

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On October 14, the Centers for Medicare & Medicaid Services (CMS) issued its final rulemaking that implemented provisions of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). Following the final rule's release, the CAP sent its members a STATLINE special report with its initial analysis of the regulation.

Measurement for the new quality payment programs will begin in 2017 and affect Medicare reimbursement in 2019. The Medicare payment adjustments to physicians in the program range from +/- 4% starting in 2019 to +/- 9% in 2022 and beyond. One payment pathway, the Merit-based Incentive Payment System (MIPS), is projected to have a $1.5 billion impact on pathology reimbursement between 2019–2024.

Key elements in the final MACRA regulation include:

  • Additional flexibility with four MIPS participation options for physicians. For instance, pathologists may avoid Medicare penalties by reporting one quality measure.
  • For MIPS, the CMS approved the CAP's eight quality reporting measures.
  • As the CAP sought changes to the definition of non-patient-facing physicians, the CMS will now define this category as those with 100 or fewer patient facing encounters. The CMS will notify pathologists about whether they meet this definition before the beginning of the MIPS performance period.
  • Pathologists, including pathologists practicing at independent laboratories, are considered eligible for MIPS and are required to participate in the program.
  • Reduced risk criteria for alternative payment models (APMs).

Read the CAP's initial analysis of the MACRA regulation.

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Diana M. Cardona, MD, FCAP, has been selected to serve on the CMS Quality Measure Development Plan (MDP) Technical Expert Panel (TEP), an advisory committee charged with providing input on future clinician quality development under the Quality Payment Program (QPP).

The CAP nominated Dr. Cardona, Associate Professor of Pathology and the Chief of the Bone and Soft Tissue Pathology Section at the Duke University Medical Center where she is also the Medical Director of the Histology Lab, the Immunopathology Lab and the Pathologist's Assistant Program. In nominating Dr. Cardona, the CAP said it believes her representation on the TEP will be essential to ensuring that pathologists, as non-patient-facing eligible clinicians, are accounted for in the MDP and are able to successfully participate in the QPP.

"As chair of the CAP Measures and Performance Assessment Subcommittee, Dr. Cardona possesses the relevant knowledge and proficiency in the landscape of current measures, measurement gaps and measure development priorities for the CMS QPP," the CAP nominating letter stated, adding that she was instrumental in the CAP development of comments on the draft MDP and has been participating in measure development of pathology measures for the past several years. Dr. Cardona has presented extensively on quality measurement programs, such as the Physician Quality Reporting System (PQRS) and the MACRA. In addition, she is knowledgeable on the priorities and principles described in the National Quality Strategy (NQS), CMS Quality Strategy, CMS Guiding Principles for Measures Development, and the National Quality Forum (NQF) measure evaluation criteria.

Measurement Development Plan

The CMS posted a draft MDP in December 2015 and the CAP engaged with the agency by suggesting changes to the plan. For example, the CAP urged the CMS to take non-patient-facing physicians, such as pathologists, into account as it finalizes the plan. On May 2, the CMS published a revised MDP, which does take non-patient-facing physicians into account.

The TEP will provide expertise and contribute direction and thoughtful input related to future quality measure development to support the QPP. This includes assessing the landscape of current measures, measurement gaps and measure development priorities for the QPP, preparing the annual report on progress in developing quality measures, developing and applying criteria to evaluate the CMS' progress on measure development, and supporting the continuing evolution of the MDP as a strategic framework for clinical quality measure development for the QPP.

The first meeting of the TEP will be November 17.

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Find out what Medicare will pay for pathology services in 2017 by registering and attending the CAP's webinar The Final 2017 Medicare Physician Fee Schedule's Impact on Pathology Services. The CAP will host this presentation for members on November 8 at 2 PM ET/1 PM CT.

Throughout this hour-long panel discussion, CAP experts will explain the changes by the CMS in the 2017 Medicare Physician Fee Schedule. Expected to be published by the CMS in late October, the fee schedule contains Medicare reimbursement and policy changes affecting pathologists.

Register today.

In July, the CMS provided detail on its intention to revalue certain pathology services targeted as potentially misvalued. For 2017, the CMS proposed increases for:

  • Pathology add-on services
  • Microslide consultations
  • Prostate biopsy, any method G-code
  • Tumor immunohistochemistry

The CMS also proposed decreases in the physician work and practice expense for some services, such as flow cytometry.

During the webinar presentation, CAP experts will discuss how the final rule affects Medicare reimbursement for pathology services and the CAP’s advocacy efforts to impact these changes. The second part of the webinar will be a question-and-answer session.

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On November 2 from 2:30–3:30 PM ET, the CMS will host a national provider Clinical Diagnostic Laboratory Test Payment System Data Reporting conference call during which clinical laboratories that are applicable laboratories under PAMA will learn how to report data under PAMA.

The call will cover system registration, a system demonstration, data submission, and data certification. The CMS also will answer questions toward the end of the call.

Register for the CMS conference call today. A link to the slide presentation will be posted to the page prior to the call.

Applicable laboratories must collect private payer rates for clinical laboratory fee schedule services for the first data collection period beginning January 1, 2016, through June 30, 2016. These laboratories then must report their data to the CMS beginning January 1, 2017, through March 31, 2017. The CMS will use this data to calculate CLFS payment rates based on the weighted median of private payer payments for 2018.

Download the list of CLFS codes subject to collection and reporting requirements.

The CMS also updated its list of frequently asked questions (FAQs). The updates are noted in red in the document and focus largely on those scenarios under which a national provider identifier (NPI) is an applicable laboratory for reporting purposes. The agency also confirms in the FAQs that final payments to be reported are determined at the code level rather than entire claim. In addition, CMS clarifies other issues regarding private payer payment including secondary coverage. Download the updated PAMA frequently asked questions document from the CMS.

The CAP will share the instructions provided during the national provider call and continue to keep members informed of additional information as the data submission period that opens on January 1, 2017 nears.

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The American Medical Association (AMA) is urging the Department of Health and Human Services (HHS) to establish policies that will help ensure network adequacy as a way of reducing unanticipated bills from providers, a position that the CAP has long held.

In October 6 comments submitted to HHS on the proposed Notice of Benefit and Payment Parameters for 2018, the AMA said the first line of defense against "surprise" bills should be establishing a regulatory framework that fosters adequate networks to provide patients with timely access to and choice of providers. "Critical to this are strong, measureable network adequacy standards that include evaluation of patients' ability to access participating providers at participating hospitals," said the AMA.

The CAP's Position

The CAP has also been a strong proponent of network adequacy. Specifically, the CAP advocates for state regulators to require health plans to ensure patients at in-network facilities have reasonable access to in-network providers. At the same time, the CAP continues to oppose out-of-network legislation, similar to the bills drafted in Colorado and Tennessee, to limit health plan financial responsibility for balance billing while failing to ensure patient access to in-network hospital-based physicians.

The CAP also encourages members to strengthen pathology's voice at the AMA and support issues, such as network adequacy, by becoming a member of the association. The size of the CAP's delegation at the AMA is representative of the number of CAP members who are also AMA members. View the AMA'S website for more information about becoming a member.

Transparency and Fair Coverage

In its comments, the AMA also called for transparency in out-of-network coverage, saying it is essential to helping patients determine whether it is cost-effective for them to pay higher premiums for out-of-network coverage and if they will truly receive the coverage they anticipate. "To accomplish transparency, insurers should be required to standardize the way in which they market and describe their out-of-network coverage, using a realistic baseline that incorporates data from sources independent of the insurance companies," the AMA said.

In addition to providing transparency in out-of-network coverage, it is important that insurers offer fair coverage for out-of-network care, said the AMA, noting that payments to non-participating providers should reflect the cost of providing that care and allowable should consider charge data from sources independent of the insurance companies. "Such fair coverage will reduce cost-shifting onto patients and maintain reasonable incentives for insurers to create adequate networks that provide access to hospital-based care," said the AMA.

The organization is also calling for transparency in network and benefit design, arguing that restrictive networks are quickly replacing more robust networks and unanticipated patient costs often result when patients access care that is outside the network or beyond the coverage offered by their plan. The AMA advocates for increased transparency about restrictions on the plans' network and benefits in marketing tools, coverage descriptions and provider directories.

The AMA also supports HHS's efforts to require that out-of-network costs count toward out-of-pocket maximums, especially in those situations where the patient did not anticipate the out-of-network costs.

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The New Hampshire Medical Society, the New Hampshire Breast Cancer Coalition, and the New Hampshire Prostate Cancer Coalition have urged the state insurance commissioner to reverse a decision to exclude pathology services from proposed health plan network adequacy rules.

In June, the New Hampshire Commissioner of Insurance Roger Sevigney declined a formal request from the CAP and the New Hampshire Pathology Society to include physician pathology services in his state's proposed health plan network adequacy rules. The purpose of network adequacy rule is to delineate the process by which the Department of Insurance evaluate health plans to ensure that enrollees in New Hampshire health plans have access to in-network medical services. The current proposed network adequacy rules of the department include numerous categories of specialty physicians and a broad array of medical services, including nail trimming and nail debridement, but the physician examination of a biopsy was intentionally omitted.

Patient advocacy and medical groups in New Hampshire urged the commissioner to reconsider the omission and bring clarity to the proposed rules.

"The proposed rules are vague, as they do not state how in-network status for pathology services fits into state requirements for health insurance plans," said an October 14 letter from the NH Breast Cancer Coalition. "Without amending the rules, it is obvious the issue will be left open for broad interpretation by health carriers and will most likely have a negative impact on the insured requiring pathology services."

Prior to the commissioner's decision to reject pathology services from network adequacy consideration, the CAP and the NH Pathology Society pointed out that the physician examination of a biopsy specimen is the eighth most frequently performed service in the state.

Earlier in 2016, New Hampshire lawmakers deferred action on legislation to prohibit balance billing of patients after opposition from pathologists and other stakeholders. The legislation sought to authorize the state Department of Insurance to set all out-of-network payment rates for every hospital-based specialty.

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