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Working to ensure patient care is guided by the best test available, the CAP engaged with the Food and Drug Administration (FDA) in support of broader labeling of companion diagnostics.

In a February 4 letter to the FDA, the CAP stated that labels should indicate the biological pathway or target of testing rather than a specific test or test process. The label should not restrict testing methodologies to only FDA-approved or FDA-cleared devices but specify the analyte to be tested.

“Broadening the label will allow patient access to valuable tests and ensure the pathologists’ ability to provide the most thorough evaluations for their patients,” the CAP said. “Further, implementation of the guidance may allow the incorporation of new scientific evidence of disease pathobiology and technical advances in device methodology.”

The FDA proposed the draft guidance in December of 2018 with the goal of making easier to get class labeling on diagnostic tests for oncology therapeutic products. The FDA said the policy, once finalized, would make it easier for providers to use the same test in helping guide the use of a class of oncology therapeutic products, rather than one specific oncology therapeutic product within that class.

In its comments, the CAP stated that one challenge for oncology therapeutics within the same group or class is of having different performance characteristics and potentially different interactions. For instance, osimertinib is approved for T790M-positive NSCLC, whereas erlotinib, gefitinib, and afatinib are not. Likewise, erlotinib is recommended for patients with leptomeningeal involvement by NSCLC.

The CAP said the package insert may have to account for the varying performance characteristics and indications for each of the drugs.

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If you are a pathologist billing Medicare Part B charges under more than one Tax Identification Number (TIN) and have multiple or National Provider Identifier (NPI) combinations, you may be at risk for a penalty in 2020.

It is possible that one or more of the TIN/NPI combinations may be exempt from MIPS participation due to the low-volume threshold if pathologists do not report for all MIPS-eligible TIN/NPI combination. However, pathologists are at risk to receive the maximum negative payment adjustment for that TIN/NPI. The CAP has guidance on how to avoid the potential penalty before the April 2 Medicare reporting deadline.

To avoid a Medicare penalty, which amounts to -5%, MIPS-eligible pathologists need to ensure that each TIN/NPI combination has reported. Moreover, pathologists should confirm that their 2018 MIPS reporting data is being submitted for the practice’s TIN locations. Otherwise, pathologists will be at risk for the penalties.

To check that your NPI is associated with the correct practice TIN in 2018, visit the CMS Quality Payment Program website. This is a valuable resource to determine pathologist specific program requirements, as well as ensure that the CMS has the correct information regarding your practice.

The deadline to submit 2018 MIPS data to the CMS is April 2, 2019. If you have questions for 2018 MIPS reporting, please email the CAP’s quality reporting experts

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To help reduce reporting burdens, the CAP asked the Office of the National Coordinator for Health Information Technology (ONC) to simplify quality measures, and reform health information and electronic health records (EHR) requirements for pathologists.

The CAP urged both the ONC and the Centers for Medicare & Medicaid (CMS) to align and simplify “quality measures across federal quality initiatives, including EHR reporting for the Merit-Based Incentive Payment System (MIPS) and Alternative Payment Models (APMs),” in a January 28 letter.

Also, the CAP asked the ONC “to acknowledge the value of clinical data registries, particularly the important role that Qualified Clinical Data Registries (QCDRs) play in enhancing quality improvement activities and reducing the administrative burden for pathologists.” The CAP wants the CMS to allow pathologists, who submit quality measures through a QCDR, to earn full credit in the Improvement Activities and Promoting Interoperability categories of MIPS.

For pathologists to fully comply with Medicare quality reporting requirements, the CAP needs a more comprehensive understanding of the agencies’ certified EHR criteria so that LISs can be deemed Certified EHR Technology (CEHRT). “This would go a long way in supporting pathologists’ efforts in promoting the electronic exchange of health information across LIS and EHRs” Further, if LIS were deemed CEHRT, pathologists would not be penalized in federal quality reporting programs, allowing them to comply in Medicare reporting requirements fully, and further reducing physician reporting burdens.

The CAP will continue to engage with the ONC and the CMS on these issues to reduce reporting burdens for pathologists.

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The CAP and the West Virginia Association of Pathologists (WVAP) opposed out-of-network (OON) billing legislation that fails to address the fundamental cause of balance billing – inadequate insurance networks.

The West Virginia House Bill legislation, HB 2380, introduced on January 14, is similar to a 2017 bill that died in committee. The measure defines “surprise” bills, adds new disclosure requirements for health care providers, and adds a requirement that insurers develop a process to handle surprise bills.

The concerns raised by the CAP and the WVAP are the same as those voiced in 2017. For example, the legislation directs that before providing non-emergency services (including pathology services), a patient must be informed of the availability of a written estimate. However, the current proposed measures does not recognize that pathology services cannot be delayed pending evaluation of the patient’s health insurance without jeopardizing the care of the patient.

“Physicians have an ethical obligation to perform services without delay when patient care and quality can be impaired,” the CAP and the WVAP stated in a January 28 letter to WV Rep. Barbara Evans Fleischauer, the bill’s sponsor. “For these reasons, both the National Conference of Insurance Legislators and the National Association of Insurance Commissioners, in their respective model bills on network adequacy, did not place any written estimate requirement on physicians to be provided as a prerequisite to performance of services.”

The legislation fails to establish strict network-adequacy standards to assess health plans seeking state approval for network adequacy of hospital-based physicians and fails to provide fundamental protections to patients by ensuring health plan network adequacy.

“Given these aforementioned deficiencies and the failure of the bill to cite the 80th percentile of FAIR Health Inc. database for determining ‘usual and customary’ rates upon which out-of-network physicians would be paid by health insurance plans, we oppose the legislation,” the letter said.

STATLINE will monitor the progress of this legislation.

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Date. February 26, 2019
Time: 1 PM ET- 2 PM ET

With the 2018 mid-term election, almost 100 new members of Congress have started and need your help to learn more about the importance and impact that Pathology has in health care. Join Donald Karcher, MD, FCAP, chair of the CAP Council on Government and Professional Affairs, David Gang, MD, FCAP, chair of the Federal and State Affairs Committee, and Jennifer Forsyth, MD, FCAP, a member of the Federal and State Affairs Committee, to learn about how your voice matters to help educate the new Congress on health care issues important to pathologists. Register today for this complimentary webinar hosted by the CAP.

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STATLINE will take a scheduled break on February 18 due to the President’s Day holiday. You will receive the next edition of STATLINE in your email inbox on February 27. Please continue to check the CAP Twitter and Facebook accounts for updates from the CAP.

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