STATLINE

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• Health Care Lawmakers Headline CAP Policy Meeting Next Week
• FDA Approves Whole Slide Imaging System to Use for Primary Diagnosis
• Accommodating Concierge Medicine, Kansas Enacts Change to Direct Billing Law
• Pathologists Oppose Bill to Establish Rates for Private Payer Services in North Carolina
• CAP Opposes Proposed House Legislation to Regulate LDTs, Establish New FDA Center
• Physician-Focused Payment Model Committee Recommends Two Bundled Payment Models
• The 2017 Practice Characteristics Survey Is Now Open

With health care reform still unsure and the pending release of potential legislation impacting the practice of pathology and laboratory medicine, the 2017 CAP Policy Meeting on April 24-26 will be an essential event for pathologists to advocate on behalf of their specialty and patients.

Join your colleagues to hear first-hand from past and current federal lawmakers such as Congressman Michael Burgess, MD, (R-TX), Senator John Boozman (R-AR), and former Senate Majority Leader Tom Daschle on the latest issues facing the healthcare landscape.

During the informative and interactive meeting, Rep. Burgess will provide his insights on the future of health care and the political environment during the Evolving Health Care Landscape discussion on Monday, April 24.

Rep. Burgess previously worked as an OB-GYN in Denton County, Texas, and currently is chairman of the House Energy and Commerce Subcommittee on Health.

Sen. Boozman, (R-AR) will be the Keynote Breakfast speaker on Tuesday April 25 during the CAP Policy Meeting. Sen. Boozman will discuss how Congress deals with the rapidly changing health care environment, review his health care priorities, and give us insight into why it is important to come to Washington, DC, and be engaged in the policymaking process during an engaging breakfast session.

Former Senate Majority Leader Tom Daschle will be the lunch Keynote Speaker on Monday, April 23. As the architect for the Affordable Care Act, Senator Daschle will discuss health care reform and provide a predictive analysis of the political and economic factors likely to influence policy and shape legislation. During his time in the Senate, Senator Daschle established himself as a leading authority on health care reform, climate change, renewable energy policy, financial services reform, and international trade and tax developments.

It's not too late to register for the 2017 CAP Policy Meeting where attendees earn 5.25 CME credits and will receive the latest information and analysis on the implementation of new Medicare and laboratory regulations.

The CAP is actively engaged in the legislative and regulatory arenas on the critical issues facing pathology and laboratory medicine, including physician payment reform, reducing regulatory burdens, and improving health care quality.

The CAP Policy Meeting will also include meetings with members of Congress and their staff during the CAP's Annual Hill Day on April 26, which is the specialty's opportunity to focus on the federal issues most important to pathologists now and in the future.

The CAP Policy Meeting is a benefit of CAP membership and there is no fee to register.

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The US Food and Drug Administration (FDA) cleared the first whole slide imaging (WSI) system to allow pathologists to use digital pathology technology for review and interpretation of slides prepared from biopsied tissue.

The FDA announced on April 12 the Philips IntelliSite Pathology Solution cleared the agency's review. This is the first and only device the FDA has permitted to market as a WSI system for primary diagnosis. In this authorization, the FDA found that the risks associated with the use of this technology to be similar to that of the use of conventional light microscopy, which provided the agency reasonable assurance of safety and effectiveness for this digital imaging system.

The CAP has actively engaged with the FDA on its guidance for how the agency assesses digital pathology whole slide imaging devices. The CAP agreed with the FDA's approach to focus on such parameters as registration of focus errors, stitching errors and completeness of the WSI.

The CAP further agreed with the FDA's approach on focusing its initial regulatory guidance on the technical performance aspects. A WSI system should not and cannot be expected to be validated separately for every diagnostic entity as a "test" measure. The CAP believes categorizing different diagnostic applications for WSI “for each intended diagnostic purpose” would result in a cumbersome regulatory process that would continue to delay adoption of this technology.

The CAP further believes our evidence-based guideline "Validating Whole Slide Imaging for Diagnostic Purposes in Pathology" complements the FDA's approach to assuring safe and effective use of WSI by providing guidance to pathologists on the method for appropriate validation. The validation guidelines were developed in 2013 and serves as a practical guide for pathologists and laboratories to confirm the accuracy and concordance of their own WSI systems for diagnostic work while ensuring the digital tool is being used properly for its intended clinical use.

Currently, there is no indication that coding of and billing for interpretive diagnostic services using transmitted and/or digitized images for anatomic pathology should differ from those using a microscope.

The CAP will continue to engage with the FDA to advocate on digital pathology.

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Kansas Gov. Sam Brownback signed into law on April 12 a provision, with support from pathologists, to amend direct billing statute in order to accommodate concierge medicine.

The CAP and Kansas Society of Pathologists (KSP) negotiated changes to the Kansas anatomic pathology direct bill law with the Kansas Medical Society in 2016. The change to the state's direct billing law satisfies the practice of concierge medicine, which charges patients a retainer fee for all medical services provided by the physician's office. Physicians under the concierge medicine model do not accept insurance.

The direct billing law for anatomic pathology was enacted in Kansas in 2007. The specific changes to the Kansas law now permit patients to be billed by an ordering concierge medicine physician for anatomic pathology services. The ordering physician must still identify the pathologist or laboratory performing the service and the amount charged for the service. In addition, the law empowers the Board of Medical Practice with authority to further regulate concierge medicine billing for such services, potentially in order to prevent markups if they deem such requirements necessary.

Similar changes in Kansas' direct billing law were negotiated in Washington State in 2012. Both Washington and Kansas regulate concierge medicine practice under a distinct set of laws.

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The CAP and North Carolina Society of Pathologists (NCSP) opposed a state Senate bill to establish a government rate payment system for out-of-network physicians in the private market.

If enacted, North Carolina Senate Bill 629 would deny out-of-network physicians in the state the legal authority to negotiate appropriate payment with health insurance plans for medical services that were rendered to their enrollees. The out-of-network care is often the result of a health plan's failure to contract for services that would otherwise be available to the patient from in-network physicians. The CAP and NCSP formally stated its opposition to Senate Bill 629 in an April 18 letter.

"Of great concern, Senate Bill 629 proposes to statutorily tie physician out of network payment to Medicare or the payer's contracted rate," the CAP and NCSP stated in the letter. "This limit on what a health plan can pay to an out of network physician, including pathologists, based upon the Medicare fee schedule or the payer's contracted rate, will devalue certain physician services and encourage the roll-back of private insurance coverage and contract."

The legislation fails to hold health insurance plans accountable for maintaining adequate networks of physicians. The CAP believes states should evaluate the adequacy for in-network pathologist participation and the timeliness, proficiency, and scope of pathology services provided, including genetic analysis, and utilization of pathology services within any insurance plan licensed or approved by a state. Payers who fail to maintain an adequate network should be held responsible for paying out-of-network pathologist providers all billed charges and at no greater out-of-pocket expense to the patient, as would be the case for an in-network provider service.

"The effect of Senate Bill 629 would be the enrichment of insurance plans and the financial undermining of both contracted and non-contracted physicians and hospital-based physician services to the general detriment of health care in North Carolina," the CAP and NCSP said. "In general, the legislation, if enacted, will be a substantial disincentive to health plan contracting for physician services. For these many reasons we urge the North Carolina Senate to reject SB 629."

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Advocating for a simple, streamlined approach to the oversight of laboratory-developed tests (LDTs) that utilizes the current regulatory structure, the CAP stated its opposition to a discussion draft of House legislation proposing a new complex system to oversee clinical laboratories and medical professionals providing quality tests for patients.

The CAP provided its comments in an April 7 letter addressing a discussion draft of a bill entitled The Diagnostic Accuracy and Innovation Act. The discussion draft is being circulated by Rep. Larry Bucschon, MD (R-IN) and Rep. Diana DeGette (D-CO). The CAP believes provisions in the draft would overburden laboratories providing quality laboratory tests.

"Instead, the CAP supports and recommends a regulatory approach for the oversight of LDTs that is flexible and uses existing regulatory structures," the CAP said in the letter. "This framework should allow for coordination between the Centers for Medicare & Medicaid Services (CMS) and the Food and Drug Administration (FDA) in order to ensure a pathway for quality clinical laboratory testing and innovation that is unimpeded and not overly burdensome to laboratories in the process."

The CAP released its principles for LDT oversight in 2009. These principles were based off the need to ensure quality testing and continued innovation that did not overburden laboratories with regulation. The CAP has maintained that enacting enhancements to Clinical Laboratory Improvements Amendments (CLIA) with a targeted role for the FDA is the most effective and least burdensome approach to LDT oversight, the CAP said.

The House discussion draft would reclassify all LDTs as in vitro clinical tests (IVCTs). The draft would place LDTs under a new regulatory paradigm and create a new center under the FDA. "The CAP objects to this regulatory paradigm since laboratories could no longer develop low- or moderate-risk LDTs outside of the purview of the FDA’s regulatory authority," the CAP stated. "We believe for most LDTs, in particular moderate- and low-risk, laboratories can provide innovative and quality laboratory testing under the current CLIA program where pathologists perform laboratory operations and develop LDTs."

Furthermore, the CAP is concerned the discussion draft would stifle innovation and limit tests available to patients. The proposal also would impose new requirements on laboratories extraneous to the purview of LDT oversight, the CAP said.

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The Committee Incorporated CAP's Comments Regarding Bundling Pathology Services into Models

The CAP attended and provided comments outlining specific issues and concerns to the Physician-Focused Payment Model (PFPM) proposals that were submitted to the PFPM Technical Advisory Committee (PTAC). The CAP was actively engaged with the PTAC on the specific models that would impact pathologists.

On April 10-11, the PTAC reviewed three proposed payment models and recommended two of the models, Project Sonar and the ACS-Brandeis Advanced Alternative Payment Model (AAPM), to the Secretary of Health and Human Services (HHS) for limited-scale testing.

During the meeting, Dr. Stephen Black-Schaffer, MD, FCAP and the vice chair of the Economic Affairs Committee for the CAP, attended the meeting and provided comments on the ACS model. PTAC did not recommend a third proposal, the COPD and Asthma Monitoring Project, finding it to have promise, but needing further development before even limited-scale implementation. A fourth proposal, the Comprehensive Colonoscopy Advanced APM for Colorectal Cancer Screening, Diagnosis and Surveillance, was scheduled to be reviewed but was removed from the agenda just before the meeting. The CAP strongly opposed the Comprehensive Colonoscopy Advanced APM for Colorectal Cancer Screening, Diagnosis and Surveillance model.

The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) created the PTAC to make recommendations to the Secretary of Health and Human Services (HHS) on proposals for PFPMs submitted by individuals and stakeholder entities. The PTAC is an independent 11 member committee appointed by the Comptroller General of the United States based on the national recognition for expertise in PFPMs and related delivery of care of its members, both physicians and non-physicians. The PTAC began accepting proposals for PFPMs on December 1, 2016. Since that date five proposed payment models have been submitted and released for public comment. The CAP commented on the Comprehensive Colonoscopy Advanced Alternative Payment Model (AAPM) and the ACS-Brandeis AAPM as both models included pathologists and their services.

PFPMs under MACRA include specialist models and are intended to encourage new alternative payment model (APM) options for Medicare physicians and practitioners especially those who might not have an opportunity to participate in existing APMs. The MACRA final rule also set forth criteria for proposed PFPMs including value over volume, integration and care coordination, patient safety, quality and cost, payment methodology, scope, flexibility, and health information technology.

Comprehensive Colonoscopy AAPM for Colorectal Cancer

In comments submitted on January 25, 2017, the CAP raised significant concerns with the Comprehensive Colonoscopy AAPM related both to some of its very premises, patient protection, and care coordination and also to its handling of pathology services. The model includes endoscopists, radiologists, anesthesiologists and pathologists (and potentially facilities) in a one-year colonoscopy episode. Under the model, the endoscopist determines annual performance targets that do not apply to pathology and for which pathologists are not eligible. It also imposed a limit on the number of pathology services. As a result, the CAP expressed opposition to the model and its inclusion of pathology services without meaningful participation for pathologists. While the PTAC’s preliminary report team released a report on this model, the model was removed from the agenda at which it was scheduled to be deliberated not long before the meeting began on April 10.

ACS-Brandeis AAPM

One of the first PFPMs proposed was the ACS-Brandeis AAPM submitted by the American College of Surgeons (ACS) and Brandeis University on December 13, 2016. The model is episode-based and built on an updated version of the Episode Grouper for Medicare (EGM) software currently used by the Centers for Medicare and Medicaid Services (CMS) for measuring resource use. The model’s logic as proposed is broad covering 54 procedural episodes in 10 clinical areas involving as many as 75 specialties including pathologists categorized under the model as ancillary providers.

In comments submitted January 5, 2017 the CAP acknowledged the intended collaboration amongst clinicians that underpins the model but felt many areas were not sufficiently addressed in the proposal. In addition, the CAP questioned how the proposal met one of the key goals of PFPMs, to expand the existing CMS APM portfolio and extend meaningful opportunities for APM participation to providers for whom it has been limited. The model, on its face, seemed to be applied to those entities that were already alternative payment or extensively integrated models.

Under MACRA, the PTAC's role is to make recommendations to the HHS Secretary. The Secretary, however, is not required to follow the PTAC’s recommendations. A detailed response to the PTAC recommendations will be posted on the Web site of the HHS Assistant Secretary for Planning and Evaluation (ASPE). As directed by MACRA, HHSs Office of the ASPE provides operational and technical support to PTAC.

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The CAP is currently fielding the 2017 Practice Characteristics Survey to gather data from individual pathology practices regarding their economics, demographics, and market trends.

On April 10, pathologists received an email from lvernon@cap.org with a link that is unique to the pathologist receiving the invitation. Respondents are eligible for a drawing for one of four $150 Amazon gift cards. If you have not received your invitation, please contact us at practicesurvey@cap.org. This survey is available to board-certified pathologists who are currently practicing in the US. The survey excludes full-time retirees, pathologists practicing in different countries, and junior members of the CAP.

The survey should take 15 minutes to complete. The CAP will share the survey findings with its members in a full report and provide early access to the data to those who finish the survey.

All responses are kept strictly confidential. Responses will be reported in aggregate form only. No individual practice information will be uniquely identified or shared.

The CAP will use the data in its advocacy efforts with policy influencers, healthcare leaders, and other stakeholders to increase understanding of the significant role and value of the pathologist in the delivery of patient care.

Survey participants are helping the CAP to better serve its members. The survey will capture:

• Vital practice member characteristic data
• Information on the concerns and challenges of the CAP member
• Compensation data, including salary and benefits
• Practice-related data

Complete your survey before it closes on May 12.

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