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As the CAP continues to engage with Congress and other stakeholders on laboratory-developed test (LDT) oversight, the House Energy and Commerce Committee released a second discussion draft of legislation to reform and provide oversight on in vitro diagnostic testing, including LDTs.

The revised plan was released ahead of an Energy and Commerce Health Subcommittee hearing to examine the regulation of diagnostic tests and laboratory operations, which was later rescheduled to November 17. The subcommittee will gather testimony from officials at the Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) regarding each agency's responsibilities and areas of expertise in the regulation of diagnostic tests.

The new Energy and Commerce discussion draft calls for the creation of a new center within the FDA to oversee in vitro diagnostics. Through reclassifying LDTs, the proposal separates what the FDA and CMS regulates under CLIA. Through CLIA modernization provisions, the draft proposes a definition for laboratory operations that includes performing pre-analytical processes for in vitro clinical test and collection, transportation, disposition, and storage of patient specimens. It also proposes new standards for quality systems for all phases of the total testing process.

The discussion draft is based on input from a Diagnostic Testing Work Group (DTWG), which is comprised of diagnostic manufacturers and clinical laboratories.

The CAP has advocated for its legislative proposal on LDT oversight to ensure quality testing without overburdening laboratories with regulation. Read the full details of the CAP's proposal. The CAP legislative proposal was recently endorsed by the Association of Pathology Chairs and has the support of the American Medical Association.

The CAP will continue to report information on this issue in future editions of STATLINE.

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The national insurer Humana will not move forward with a policy to deny reimbursement for the technical component (TC) of pathology services provided to hospital patients when billed by a pathologist or independent laboratory.

The policy, dated June 2015, was to affect both Humana's commercial and Medicare Advantage plans on January 1. Under the policy, "when a facility is expected to bill for the TC," Humana would have only made payment for a charge submitted by the associated hospital when the TC of a pathology service is provided to a hospital patient.

The CAP began to engage with Humana regarding the policy in September. The CAP then learned on October 20 that Humana decided not to roll forward with implementation on January 1. Humana has removed the policy from its website.

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The CMS is poised to finalize new reimbursements for pathology services and other policy changes in the 2016 Medicare Physician Fee Schedule on or around October 30.

The White House Office of Management and Budget received on October 13 the 2016 Medicare Physician Fee Schedule for review, which is a final step before the document is released publically. The CMS does not say when the final rule will be published, but the CAP expects the fee schedule to be finalized within the next two weeks.

Once the fee schedule is released, the CAP will analyze the rule and provide its initial analysis in a STATLINE Special Report to CAP members. Members also are encouraged to register for the November 5 webinar, "The 2016 Medicare Physician Fee Schedule's Impact on Pathology Services." Throughout this hour-long panel discussion, CAP experts will explain reimbursement and policy changes by the CMS in the 2016 fee schedule. Some of the key Medicare reimbursement changes are expected for immunohistochemistry, immunofluorescence, and prostate biopsy services in 2016. The webinar will begin at 2 PM ET on November 5.

Register for this webinar today.

Presenters for the webinar will be CAP Economic Affairs Committee (EAC) Chair Jonathan L. Myles, MD, FCAP; EAC Vice Chair W. Stephen Black-Schaffer, MD, FCAP; and EAC Measures & Performance Assessment Subcommittee Chair Diana M. Cardona, MD, FCAP. CAP Policy and Advocacy Vice President John H. Scott will be the webinar moderator. During the presentation, the panel will answer questions from CAP members.

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The CAP is inviting stakeholders to provide comments on draft quality measures for pathologists through a short survey. Your comments are important as CAP leaders work to ensure pathologists can participate in Medicare value-based initiatives.

The CAP convened its Measures & Performance Assessment (M&PA) Subcommittee to assess opportunities for the development of evidence-based performance measures for pathologists. The CAP M&PA Subcommittee, which is part of the CAP Economic Affairs Committee, proposes these measures to promote the highest quality of care.

Please see below an overview of the measures. You may access detailed measure specifications by clicking on the individual measures below. The three new measures are for registry reporting only. Hence, the measure descriptions do not include coding that is required for measures specified for claims and registry reporting. The CAP is recommending that the two existing measures on breast and colon cancer reporting be modified with the intent of including the modifications beginning in 2017. These two measures are specified for both claims and registry reporting and have the requisite coding included in the measure specifications.

Three new measures

  1. Amended Reports with Change in Categorical Interpretation
  2. Amended Reports with Changes to Secondary Diagnostic Information
  3. Cancer Checklist Elements Completed

Modification of Existing Measures (Please see highlighted modifications in the detailed measure specifications links below):

  1. Breast Cancer Resection Pathology Reporting with Margin Status
  2. Colorectal Cancer Resection Pathology Reporting with Margin Status

The four week comment period begins on October 27 and will close at 5:00 PM ET on November 24. All comments are welcome and will be compiled and shared with the M&PA Subcommittee for consideration.

Please feel free to forward this link to others within your organization or constituency who may offer insight and expertise.

Please do not hesitate to contact Fay Shamanski at or Loveleen Singh at if you have any questions. Thank you for your participation in this public comment.

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As a result of CAP advocacy, pathologists will receive an automatic hardship exception from Medicare penalties under the Electronic Health Record (EHR) Meaningful Use initiative in 2016 following the release of the program's Stage 3 regulation.

The CAP will continue to engage with the CMS on providing penalty relief to pathologists in future years and will submit formal comments in response to the Meaningful Use final rule published October 6. The American Medical Association (AMA) also is inviting physicians to send comments regarding the Meaningful Use program to the CMS through its Break the Red Tape website.

The CMS is continuing the 2015 automatic hardship exception through 2016, which means pathologists won't receive penalties that lower Medicare payments by 1% in 2015 and 2% in 2016. The CAP advocates for relief from the penalties because pathologists use laboratory information systems, and not EHRs, and are unable to meet EHR Meaningful Use requirements. Although the CAP has a minority of members that have successfully attested to Meaningful Use, it is because they are likely part of larger practice organizations, the leaders of whom may be making practice-wide attestations on behalf of all of their physicians, including their pathologists.

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Register for a CMS national provider call on November 10 that will review the proposed changes to the Medicare Clinical Diagnostic Laboratory Test Payment System stemming from the Protecting Access to Medicare Act (PAMA).

On September 25, the Medicare agency published its proposed PAMA regulation to implement reforms to the Medicare Clinical Laboratory Fee Schedule (CLFS). Under PAMA, clinical laboratory fee schedule (CLFS) payment, beginning in 2017, will be the weighted median of private payer rates based on data collected from applicable laboratories. The CMS rule proposes laboratories that receive at least $50,000 a year in Medicare revenues from payments under the CLFS and organizations that derive more than 50% of their Medicare revenues from CLFS and physician fee schedule services during a data collection period would be subject to new private payer reporting requirements. The CMS proposed a deadline of March 31, 2016 for the initial collection period.

On the national provider call, the CMS will discuss the proposed policy changes in the Clinical Diagnostic Laboratory Test Payment System proposed rule on November 10 at 2 PM ET.

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