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With Congress considering legislative options to providing oversight of laboratory-developed tests (LDTs), the CAP welcomes the Association of Pathology Chairs' (APC) endorsement of the CAP’s legislative proposal for LDT oversight.

The APC serves as the voice of academic departments of pathology in the United States, Canada, and Puerto Rico. After analyzing the CAP legislative proposal, APC leaders determined the CAP's approach was more aligned with its position on LDTs. The APC Council then voted in favor of endorsing the CAP’s legislative proposal. The endorsement was announced to APC's membership on October 16.

The CAP welcomes the APC endorsement of the legislative proposal. In September 2015, the CAP released its legislative proposal, based on a 2009 framework, which strikes the right balance to LDT oversight through a public-private approach. In addition to the APC, the American Medical Association (AMA), the largest association of physicians in the United States, supports the CAP's framework for LDT oversight by raising standards to ensure quality testing without overburdening laboratories.

Read the full details of the CAP legislative proposal.

The CAP proposal is one of several proposals currently being discussed in Washington. On Capitol Hill, the House Energy & Commerce (E & C) Committee is planning to release a second LDT legislative draft based off a revised Diagnostic Testing Work Group (DTWG) proposal. The DTWG is comprised of diagnostic manufacturers and clinical laboratories. The CAP also anticipates the E & C Committee will hold a hearing on LDTs in late October.

The Senate (HELP) committee is also speaking with stakeholders and continuing its work on an alternative LDT proposal. The CAP remains engaged with congressional committees and continues to strongly advocate for its legislative proposal as the best approach to LDT oversight.

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The Centers for Medicare & Medicaid Services (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 launched its new Local Coverage Determination (LCD) Advisory Panel to help ensure that all pathologists are appropriately reimbursed for medically reasonable and necessary services provided to Medicare patients and to establish a systemic process for assessing the dozens of draft LCDs subject to review each month.

When a Medicare Administrative Contractor (MAC) develops a LCD or significantly revises an existing LCD, the CMS requires that MACs provide the physician community and the public an opportunity to contribute though a public comment period before an LCD is implemented. The CAP actively reviews and comments on LCDs affecting pathology services. The CAP's new panel plays a key role in this process.

The LCD Advisory Panel, consisting of members of the CAP Economic Affairs Committee and Council on Scientific Affairs, coordinates and conducts reviews of new draft LCDs and writes formal comment letters to MACs. Pathologists on the Carrier Advisory Committee (CAC) continue to be the primary representatives for all communications with MAC medical directors. CAP members can track the status of Medicare LCDs that the CAP has reviewed and/or advocated for fair reimbursement policies at the local Medicare level.

The CAP provides its members with a table consisting of the Medicare LCDs (CAP-member login required) that the CAP is reviewing or has reviewed for comment. The procedures for the CAP review and comment are explained in the Local Medicare Payment and CAP Coverage Program. The CAP's comments on the LCDs can also be downloaded for review.

The CAP may decide to comment individually, in collaboration with other associations, or through the network of state pathology CAC representatives.

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The CMS released the 2014 Quality and Resource Use Reports (QRURs) and Physician Quality Reporting System (PQRS) Feedback Reports for physicians and their practices to download, review, and request corrections, if needed. Any corrections are due to the CMS by November 9.

Information contained in the reports has a direct impact on physician Medicare payments in 2016. And, any errors contained in the reports could negatively affect reimbursements that year.

The 2014 QRURs show how groups and solo practitioners performed in 2014 on the quality and cost measures used to calculate the 2016 value-based modifier. For groups with 10 or more eligible professionals that are subject to the 2016 value modifier, the QRUR shows how the modifier will apply to physician payments under the Medicare Physician Fee Schedule for physicians who bill under the group's tax identifier number (TIN) in 2016.

For all other groups and solo practitioners, the QRUR is for informational purposes only and will not affect their payments under the Medicare PFS in 2016. Authorized representatives of group and solo practitioners can access the 2014 QRURs on the CMS Enterprise Portal using an Enterprise Identify Data Management (EIDM) account with the correct role. For more information on how to access the 2014 QRURs, please read the CMS's guidance on How to Obtain a QRUR.

For groups with 10 or more eligible professionals that are subject to the 2016 Value Modifier, the CMS established a 60-day informal review period that begins after the release of the 2014 QRURs, to request a correction of a perceived error in their 2016 value modifier calculation. The informal review period for the 2016 modifier is open from September 9 through November 9. Information about how to request an informal review is available from the CMS.

Groups and solo practitioners are identified in the QRURs by their TIN. The QRURs are also available for groups and solo practitioners that participated in the Medicare Shared Savings Program, the Pioneer Accountable Care Organization (ACO) Model, or the Comprehensive Primary Care initiative in 2014, in addition to those TINs consisting only of non-physician eligible professional.

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Information blocking practices through electronic health record (EHR) donation arrangements may adversely affect anti-kickback statute safe harbor protection, the Health and Human Services Office of Inspector General (OIG) reminded in an agency alert to health information technology vendors, hospitals, and physicians recently.

The CAP has communicated its concerns about anticompetitive business practices, including excessive interface fees, involving EHR vendors and systems in the past. And, the OIG Alert on October 6 reminds vendors and providers that such practices affect safe harbor protection.

The OIG Alert details that the intent of the safe harbor is to protect beneficial arrangements that would eliminate barriers to the adoption of EHRs without creating undue risk of inducing rewards of extra business. The OIG warned against any action taken by a company to limit the use of donated items by charging fees to deter non-recipient providers and the donor's competitors from interfacing with the donated system. Such arrangements “would pose legitimate concerns that the parties were improperly locking in data” and not qualify for safe harbor protection.

"OIG remains committed to investigating potentially abusive arrangements that purport to, but do not actually, meet the conditions of the EHR safe harbor," the OIG stated. "OIG continues to encourage the public to report instances when a donor (or someone on their behalf) acts to limit the interoperability of donated items or services, because OIG believes that, when such lock-in has occurred, investigation may establish that safe harbor conditions have not been met."

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