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The CAP filed an amicus brief in support of the American Clinical Laboratory Association’s (ACLA’s) appeal to overturn a decision to dismiss its lawsuit to correct the Department of Health and Human Services’ (HHS’) execution of reforms to Medicare’s clinical laboratory fee schedule on December 11.

The brief, filed by the CAP, along with AdvaMed and the National Association for Support of Long-Term Care, supports the current ACLA appeal to reverse a US District Court decision. That decision dismissed the ACLA’s efforts to set aside how the HHS implemented the new market-based Medicare pricing for laboratory tests under the Protecting Access to Medicare Act (PAMA) of 2014.

In addition to supporting this current legal challenge to PAMA, the CAP continues to advocate on behalf of its members and work with Congress to amend PAMA to ensure that reimbursements for clinical laboratory tests are accurate and truly reflect the cost of patient care.

Read the full release and the amicus brief.

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The Centers for Medicare and Medicaid Services (CMS) released the final 2019 payment rates for Clinical Laboratory Fee Schedule (CLFS) along with information for mapping payment for new codes for clinical laboratory tests, and updates for laboratory costs subject to the reasonable charge payment. These rates are effective for claims with dates of service on or after January 1, 2019.

Under the 2019 CLFS final regulation, reporting laboratories must report to the CMS certain private payer rate information (applicable information) for their component applicable laboratories. The announcement also includes information regarding the next data collection period which is from January 1, 2019, through June 30, 2019.

From July 1, 2019, through December 31, 2019, laboratories and reporting entities can review and assess whether the applicable laboratory thresholds are met and validate applicable information before it is reported to the CMS.

The CMS has additional information and guidance on the 2019 CLFS rates as well as the 2019 reporting requirements. STATLINE will provide updates during the data collection period.

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New guidance issued by a New Jersey agency on the state’s recently enacted out-of-network (OON) law effectively addresses concerns of the CAP and the New Jersey Society of Pathologists (NJSP) regarding the ability of physicians to waive patient charges in cases where there is a financial need but raises new issues concerning balance billing.

The Out-of-Network Consumer Protection, Transparency, Cost Containment, and Accountability Act passed June 1 and became effective August 30. The act enhances consumer protections from surprise bills for OON health care services, in addition to making changes to several elements of New Jersey’s health care delivery system. Essentially, the law requires carriers to ensure that covered patients are not billed for inadvertent OON services more than what an individual would have incurred with an in-network provider.

On November 20, the Department of Banking and Insurance issued guidance on the act’s implementation pending adoption of final rules. While the CAP and the NJSP had initially requested a veto of the bill over concerns that it could prevent physicians from waiving patient charges, the guidance appears to resolve those issues.

Specifically, the guidance states that it is permissible, on a case-by-case basis, for OON health care providers to waive or rebate all or part of a patient’s deductible, copayment or coinsurance “after determining in good faith that the covered person is in financial need.”

However, the guidance appears to conflict with the actual law on the issue of balance billing. The guidance states that “providers must not balance bill covered persons for inadvertent and/or involuntary out-of-network services even if those covered persons sign waivers for, or consent to, those services.” This conflicts with the law’s provisions that the prohibition on balance billing “does not apply to a covered person who knowingly, voluntarily, and specifically selected an out-of-network provider for health care services.”

Under the law, a bill is not considered a “surprise” bill if the patient chooses to receive services from an OON provider when an in-network provider is available.
The CAP will continue to work with New Jersey regulators on ensuring the guidance implementing the OON Act accurately reflects the intent of the law.

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The rules for the Merit-based Incentive Payment System (MIPS) will be significantly tougher for physicians next year. For instance, practices with 16 or more eligible clinicians can no longer rely on reporting quality measures via Part B claims through a billing company as 2019 rules state these practices must use another mechanism, such as a qualified registry or a qualified clinical data registry (QCDR) like the Pathologists Quality Registry.

The CAP compiled a comparison chart detailing this and other changes, as well as criteria that remains unchanged, affecting MIPS participation next year. The 2018-2019 MIPS comparison chart is available to download at

Other key changes pathology practices, which the CAP first reported in November, should know ahead of the 2019 MIPS performance year, include

  • Eligible clinicians must score at least 30 MIPS points in 2019 to stop a Medicare payment penalty in 2021. This minimum threshold increased from 15 points in 2018. 
  • Maximum payment bonuses and penalties based on 2019 MIPS performance will also increase. The maximum penalty is -7%, which would be levied in 2021, for practices failing to meet the minimum threshold in 2019. While it’s unknown what the maximum bonus will be in 2021, Medicare statute caps positive adjustments at 7% for 2019 performance. The maximum bonus depends on how many eligible clinicians are receive penalties as MIPS is a budget neutral program. 
  • Once the 2018 MIPS performance period ends, the CMS will retire three pathology quality measures for breast cancer resection reporting, colon cancer resection reporting, and quantitation IHC evaluation of HER2 testing in breast cancer patients.

For additional information and resources, visit the MIPS for Pathologists section at

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Individual clinicians using Part B claims to report quality measures can now receive feedback from the CMS on progress toward meeting MIPS criteria for the 2018 performance year.

An eligible pathologist can access his or her 2018 performance feedback by going to the Quality Payment Program website and logging in with an Enterprise Identity Management (EIDM) username and password. The CMS released an instructional video showing how eligible pathologists can view their 2018 MIPS performance feedback for quality performance data submitted via claims. This feedback is available monthly. 

For those pathologists participating in the Pathologists Quality Registry, they receive real-time feedback with a performance dashboard. For questions about 2018 MIPS reporting, please email

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Reports for performance in the 2016 Physician Quality Reporting System (PQRS) will only be available to download from the CMS until December 31.

A pathologist can access his or her PQRS feedback report and The Quality and Resource Use Report through a CMS portal, which requires using an Enterprise Identity Management system account. The CMS has additional instructions on signing up for an account and accessing the reports on its website.

The Quality Payment Program’s MIPS reporting track replaced the PQRS program.

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Emily E. Volk, MD, FCAP

As part of our ongoing commitment to ensure pathologists can successfully participate in new and evolving payment models, the CAP continues to offer MIPS educational webinars. All MIPS webinars are available for download

The final webinar in our Decoding MIPS series is open for registration, Steps to Take Before Reporting MIPS Data, and will take place on January 8, 2019, at 3 PM ET. During the webinar, Emily Volk, MD, MBA, FCAP, will ways of maximizing your scoring for 2018 before submitting results to CMS. Register today.

An accurate diagnosis is perhaps the most critical factor in effective patient care. No one knows this more than you. Connect with and educate legislators and policy experts on the value that pathology brings to the health care continuum.

Register and join us at the:

2019 Policy Meeting
April 29—May 1
Marriott Metro Center, Washington, DC

Make pathology’s impact on patient care heard in Washington.

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STATLINE will take a scheduled break on December 25 and January 1. You will receive the next edition of STATLINE in your email inbox on January 7. Please continue to check the CAP TWITTER, FACEBOOK, and CAPCONNECT accounts for updates from the CAP.

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