Read the Latest Issue of STATLINE

April 4, 2017

In This Issue:

The CAP Strongly Supports Legislation to Improve Patient's Access to Care

The CAP commended the reintroduction of the Local Coverage Determination Clarification Act of 2017. The bill would improve transparency and accountability when Medicare contractors set local coverage determination (LCD) policies for physician services provided to Medicare beneficiaries. These decisions affect millions of Medicare beneficiaries and impact critical access to innovative technologies and procedures.

Senators introduced this key piece of legislation for physicians and patients on March 30. The Senate bill’s sponsors Sen. Johnny Isakson (R-GA), Sen. Tom Carper (D-DE), Sen. Debbie Stabenow (D-MI) and Sen. John Boozman (R-AR) have long supported this issue and have been working with the CAP on improving the LCD process.

"Reforms in this legislation would ensure that Medicare local coverage determinations do not supersede physician medical judgment and deny patients access to medically necessary care. The Senate bill would ensure that coverage decisions are made by qualified, independent health experts through a transparent process that is based on sound medical evidence," said CAP President Richard C. Friedberg, MD, PhD, FCAP, after the bill was introduced in the Senate. "The CAP thanks Senators Isakson, Carper, Stabenow, and Boozman for sponsoring this important legislation on behalf of patients and the physicians who treat them."

"Medicare's current Local Coverage Determination process is broken, and as a result, senior citizens and people with disabilities are at risk for being denied access to innovative health care services," said bill sponsor Sen. Johnny Isakson (R-GA). "I'm proud to join in this effort to introduce legislation which will help ensure patients get the best possible care by improving the transparency and communication during the coverage determination process."

"Currently the Local Coverage Determination process lacks transparency, accountability, and stakeholder input," said bill sponsor Sen. Tom Carper (D-DE). "The Local Coverage Determination Clarification Act of 2017 will improve the process by including key stakeholder input from doctors and patients, which will provide constructive expertise and guidance for Medicare contractors. This will, in turn, help determine local coverage policies for health care services that are in the best interest for Medicare patients."

"Today, seniors in Michigan lack access to critical treatments and tests that are available in other parts of the country," said bill sponsor Sen. Debbie Stabenow (D-MI). "Our bill ensures that Michigan's seniors and their doctors play a stronger role in determining what options are available through Medicare."

"The Local Coverage Determination process lacks transparency, accountability and key third party input needed to protect American health care," said bill sponsor Sen. John Boozman (R-AR). "The Local Coverage Determination Clarification Act of 2017 incorporates input from doctors and patients, providing much needed expertise for Medicare contractors, and will help to determine local coverage policies for physicians' services that are in the best interest for our nation's seniors."

Key provisions in the Senate bill include:

  • Open Meetings: Medicare Administrative Contractor's (MAC) Carrier Advisory Committee (CAC) meetings must be open, public, and on the record. Minutes should be posted to the MAC’s website for public inspection. The gravity of limiting or precluding coverage for both beneficiaries and practitioners heightens the need for transparency where meetings are currently closed.
  • Upfront Disclosure: MACs should include at the outset a description of the evidence considered when drafting an LCD as well as the rationale they rely on to deny coverage. If this information is not provided until the final LCD, it hinders meaningful stakeholder exchange and makes the MAC's decision to deny coverage almost a foregone conclusion.
  • Meaningful Reconsideration and Options for Appeal: A meaningful LCD reconsideration process gives Medicare providers and suppliers the opportunity to have a secondary review by a qualified disinterested party. Under current Centers for Medicare & Medicaid Services (CMS) rules, MAC LCDs are essentially unreviewable for providers and suppliers without new evidence submitted to the MAC that issued the LCD.
  • Stopping the use of LCDs as a backdoor to National Coverage Determinations (NCDs): Prohibit the CMS from appointing a single MAC, either expressly or in practice, from making determinations to be used on a nationwide basis in a given specialty. The CAP has witnessed the carbon copy adoption of MAC LCDs by other MACs without the benefit of meaningful solicitation or independent assessment of comments and concerns from the public or medical community of the adopting MAC. In doing so, the policy approaches becoming a NCD in practical terms without ever having followed more rigorous requirements.

The CAP, along with coalition members Advanced Medical Technology Association, the Amputee Coalition, the American Society of Clinical Oncology, the American Society of Radiation Oncology, and the US Oncology Network have come together because they believe that LCDs should not limit patient access to needed technologies and services. This legislation would make significant improvements to the LCD process and ensure that medical evidence is not used selectively to deny appropriate coverage to Medicare beneficiaries.

STATLINE will continue to monitor LCD legislation.

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Following advocacy by the CAP with the agency overseeing reforms to the clinical laboratory payment system, the Centers for Medicare & Medicaid Services (CMS) issued what is effectively a 60-day delay of the Protecting Access to Medicare Act (PAMA) data submission period for applicable laboratories. On March 30, the CMS announced that it will exercise enforcement discretion with respect to data reporting and the potential assessment of civil monetary penalties until May 30, 2017.

The CAP recently joined with other laboratory groups to seek a delay in implementation of the new Medicare payment system for clinical laboratory tests scheduled to take effect January 1, 2018, in a recent letter to Health and Human Services Secretary Tom Price, MD. In the letter, the CAP along with several laboratory groups stated that the CMS and laboratories needed additional time to address data collection concerns to collect and ensure accurate submission of all applicable data as this impacts the accuracy of final payment rates for clinical laboratory tests.

The CAP, along with the American Clinical Laboratory Association (ACLA), National Independent Laboratory Association (NILA), and seven others, said they had significant concerns about implementation of the Medicare clinical laboratory fee schedule (CLFS) reform as mandated by PAMA and that applicable laboratories need more time to submit their data. Many laboratories are still in the data collection phase as they struggle with the CMS regulatory requirements, note the signed laboratory organizations. The CMS acknowledged industry feedback in its announcement of the delay.

The data reporting period for PAMA was scheduled to conclude on March 31, 2017, but now applicable laboratories effectively have until May 30, 2017, to submit their required data.

Applicable laboratories must report the required information for all payments received from private health insurers for specific clinical laboratory tests provided between January 1, 2016, and June 30, 2016. The CMS has published a list of 1,300 clinical laboratory servicessubject to data collection and reporting requirements.

To help laboratories gather their data, the CAP developed pathology specific PAMA resources, including an informative infographic and podcast, to help laboratories understand regulatory requirements and upcoming deadlines. These resources and additional tools can be found on the CAP PAMA resources web page.

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Sen. John Boozman, MD, (R-AR)

The CAP is excited to announce that Senator John Boozman, MD, (R-AR) will be the Keynote Breakfast speaker on Tuesday April 25 during the CAP Policy Meeting.

As an ophthalmologist and one of three physicians in the Senate, Sen. Boozman will discuss how Congress will deal 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.

Other confirmed speakers are Julie Khani, President of the American Clinical Laboratory Association (ACLA); Jean D. Moody-Williams RN, MPP, Deputy Director of the Center for Clinical Standards, and Quality, the Centers for Medicare and Medicaid; and Kevin Donnelly, CEO/Executive Director of the Physician Consortium for Performance Improvement (PCPI) who will present at the CAP Policy conference on April 24-26, 2017 in Washington, DC.

On Monday, April 24, Julie Khani will speak on how the repeal and replacement of the Affordable Care Act creates an opportunity for the CAP to address regulatory issues originating from the legislation that negatively impact pathology and subsequent laws, such as Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) and Protecting Access to Medicare Act (PAMA). Ms. Khani leads ACLA's efforts to advance public policies that promote innovation and protect and enhance patient access to life-improving and life-saving diagnostics.

Jean D. Moody-Williams and Kevin Donnelly will bring their unique perspectives regarding the impact on pathology of the implementation of the Merit-based Incentive Payment System and Advanced Alternative Payment Models created by the Medicare Access and CHIP Reauthorization Act on Monday, April 24. As the Deputy Director of the Center for Clinical Standards and Quality at CMS, Ms. Moody-Williams is responsible for Quality Improvement Programs and many of the agency's value-based purchasing and public reporting programs for hospitals, physicians, and ambulatory settings. Mr. Donnelly is the CEP/Executive Director of the PCPI which is a membership organization uniquely focused on improving patient health and safety through the advancement of measurement science, quality improvement, and clinical registries.

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 will be an essential event for pathologists to advocate on behalf of their specialty and patients.

Attendees at the CAP Policy Meeting 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. There is no fee to register.

Join your colleagues—register for the 2017 CAP Policy Meeting, April 24–26, in Washington, DC. Earn 5.25 CME credits.

Want to learn more about advocacy and how to get engaged before attending the CAP Policy Meeting? Register for our complimentary webinar, Essential Tools for Pathologists Engaging in Grassroots Advocacy, on tomorrow, April 5, at 2 PM ET.

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

On or around April 10, pathologists will receive an email from with a link that is unique to the pathologist receiving the invitation. Respondents will be eligible for a drawing for one of four $150 Amazon gift cards. If you have not received your invitation, please contact us at This survey will be 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

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The CAP and state pathology societies are working to prevent enactment of legislation that would require physicians to provide written estimates of services prior to providing them. The requirement for "written estimates" has come up in states considering legislation to address out-of-network balance billing by hospital based physicians.

In a March 21 letter to Richard Smith, chairman of the House Insurance Committee in Georgia, the CAP argued that Senate Bill 8 could potentially result in delays of pathology services being performed, thus jeopardizing patient care. "Some surgical specimens require prompt analysis to be reported to the surgical team while the patient is under anesthesia and undergoing a surgical or diagnostic procedure," wrote CAP President Richard Friedberg, MD, PhD, FCAP. "This analysis cannot be delayed without potential for patient harm."

Dr. Friedberg further noted that pathologists cannot predict the type or number of specimens that will be needed or anticipate what separate studies may be necessary, thus making it impossible to provide a reliable estimate of charges or cost.

"It is for this very reason that this requirement was rejected by both the National Association of Insurance Commissioners (NAIC) and the National Conference of Insurance Legislators (NCOIL) in their consideration of model legislation on this issue," wrote Dr. Friedberg, who urged lawmakers to amend or defeat the bill. Senate Bill 8 died in the Georgia House Rules Committee after passing the Georgia Senate earlier this session. The Georgia bill will be taken up again next year.

Similar Bill Pending in Oklahoma

Meanwhile, similar legislation in Oklahoma (House Bill 2216) has passed the House and is now pending in the Senate. The bill would, in part, require physicians to provide written estimates of out-of-network medical and pathology services 14 days before the medical service is performed. The CAP and the Oklahoma State Association of Pathologists (OSAP) are actively opposing the bill. In a March 27 letter to the chairs of the Senate Health & Human Services Committee and the Retirement & Insurance Committee, OSAP President Michelle Leigh Ehrlich Powers, MD, MBA, FCAP, argued that the requirement for a written estimate "cannot be reconciled with the basic demands of many pathology procedures for which the service is unanticipated."

Ethical and legal standards of care do not allow for the performance of these services to be delayed by insurance considerations, which could be detrimental to quality and to the actual performance of the service, she noted.

"In order to protect the quality of health care in Oklahoma, we urge that the bill be amended to delete this requirement for a written estimate by a health care provider to be provided to the patient 14 days in advance of services; or alternatively, the requirement should be exclusively placed upon the health insurance carrier, or the legislation should be rejected," wrote Dr. Powers. The CAP will continue to oppose legislation that would interfere with patient care by requiring providers to provide advance written estimates of the cost of services.

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Whether you are a seasoned Policy Meeting veteran or a first timer thinking about going to the 2017 CAP Policy Meeting, then the Essential Tools for Pathologists Engaging in Grassroots Advocacy webinar on April 5 at 2 PM ET is for you.

With new regulations taking shape that will impact pathology reimbursements for years to come, grassroots advocacy for pathologists is more important than ever. The Essential Tools for Pathologists Engaging in Grassroots Advocacy webinar will provide a foundational training for CAP members who are attending the 2017 CAP Policy Meeting by covering the basics of how Congress works, why grassroots advocacy matters, and the tools and resources the CAP provides for members. This webinar will help provide a general understanding of grassroots advocacy before you arrive in Washington.

During the webinar you will hear from experienced advocates Joe Saad, MD, FCAP, Federal and State Affairs Committee chair; Al Campbell, MD, FCAP, Grassroots Subcommittee chair of the Federal and State Affairs Committee; and moderator Michael Giuliani, advocacy senior director of the CAP.

Register today for the webinar.

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