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The CAP advocated for the Centers for Medicare & Medicaid Services (CMS) to further extend its “14-day rule” policy to allow laboratories to directly bill for molecular pathology tests and advanced diagnostic laboratory tests (ADLTs) regardless of the place of service.

Despite 2018 revisions to improve the 14-day rule laboratory date of service (DOS) billing policy in the hospital outpatient setting starting this year, these changes did not address tests performed on hospital inpatients and obtaining payment for some laboratory tests remains problematic. The CAP, in a March 21 letter to the CMS, called for the changes made under the Hospital Outpatient Prospective Payment System (HOPPS) to be applied to hospital inpatient settings. The CAP also advocated for expanding the exclusions from the HOPPS packaging policy to include fluorescence in situ hybridization (FISH) technical component services in outpatient and inpatient hospital settings. Excluding FISH from packaging policy would allow for the direct billing of these tests provided at hospitals.

Apply recent 14-day rule revisions to hospital inpatients

For 2018, the CMS implemented modifications to its date of service policy for hospital outpatients to allow laboratories to bill Medicare directly for molecular pathology tests and ADLTs. “Regardless of the location or date of the testing, the services performed during an inpatient or outpatient encounter are typically unrelated to those driven by molecular testing,” the CAP said. “For example, if blood is drawn at the same time a cancer patient receives chemotherapy during an outpatient encounter (eg, for the purposes of determining potential metastasis or minimal residual disease) the results of testing completed on that specimen will inform treatment during a future, not the current, encounter.”

“Thus, regardless of the place of service, a revised DOS policy that allows the performing laboratory to bill directly for molecular pathology tests and ADLTs, rather than receiving payment from the hospital, would reduce administrative and billing complexity for hospitals, clinical laboratories, treating physicians and Medicare beneficiaries, and promote timely access to patient testing,” the CAP said.

Exclude FISH services from packaging policy

“Tests on tissue samples acquired from patients during inpatient and outpatient visits are critically important for determining follow-up treatment plans and responsible patient care,” the CAP stated in its letter. “The goal is to have all test results in hand prior to the oncologist (or other physicians) making the treatment decision to explore the best quality- and value-based options for the patients.” Excluding one would limit capabilities, as well as create unmanageable scenarios within laboratories, to provide comprehensive, guideline-based results in a cohesive and timely manner.

The CAP urged the CMS to exclude FISH technical component services (CPT codes 88364, 88365, 88366, 88367, 88368, 88369, 88373, 88374, and 88377) from the HOPPS packaging policy as the services have unique clinical utilization distinct from conventional laboratory tests.

Stay tuned for more updates in STATLINE.

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n a victory for the CAP, Wyoming Governor Matthew Mead has signed into law a genetic information privacy BILL (HB 119) that ensures clinical laboratories and pathologists will not be inadvertently impeded by the protections afforded to patients.

The new law (Public Act 60) prohibits the collection, retention, and disclosure of genetic information without the informed consent of the individual or an authorized representative, with some exceptions. The same measure was passed last year but was vetoed by Mead over concerns that an amendment added late in the process could be interpreted to prohibit genetic testing facilities, research facilities, and universities from using a third party to store or back up their genetic testing data.

The measure signed into law on March 14 includes an amendment advocated by the CAP that provides an exemption from obtaining informed consent, which otherwise would have been a requirement on a laboratory or pathologist. The CAP argued that the bill should differentiate genetic testing for diagnosis and treatment from the predictive testing that is the subject of the bill’s protection and control. Without inclusion of the amendment, the bill would have the unintended consequence of impeding standards of care in cancer diagnosis and treatment and other types of now standard medical practice activities.

Specifically, the amendment provides an exception to the requirement for informed consent for the diagnosis or treatment of the individual if performed by a clinical laboratory that has received a specimen referral from the individual’s treating physician or another clinical laboratory. Nothing in the amendment waives the requirement that a treating physician obtain specific informed consent for the taking of a specimen when required.

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Oregon Gov. Kate Brown signed into law legislation projected to limit out-of-network insurance payment for certain pathology services to as low as 75% of Medicare, according to data calculations made available from the Oregon All-Payer Claims Database. The CAP and Oregon Pathologists Association had strongly opposed the legislation and urged the governor to veto the bill as it favors insurance companies and adversely affects patients.

“It is our belief that as a consequence of this legislation, patients in Oregon may not have access to certain out-of-network services in diagnostic pathology that may not be economical to provide under Senate Bill 1549,” wrote CAP President R. Bruce Williams, MD, FCAP in a February 28 veto letter to Gov. Brown. “In general, this legislation undermines the health care delivery system for the financial benefit of the health insurance industry.”

The law establishes out of network payment at the “median” of the in-network rate, excluding the patient’s financial responsibility, determined at a 2015 baseline year. This will result in many pathology services receiving insurance company payment less than 100% of Medicare rates. Under the law, the baseline will be determined from commercial insurance data generated in the Oregon All-Payer Claims Database and payment will be annually adjusted for inflation using the National Consumer Price Index.

Enactment of the new law was supported by the Oregon Medical Association, the Oregon Chapter of the American College of Emergency Physicians, and the Oregon Society of Anesthesiologists.

In 2017, a ban on balance billing for services provided out-of-network was enacted with an effective date of March 1, 2018. During the summer of 2017, the CAP was among several state-designated medical specialty stakeholders who participated in a process for determining appropriate out-of-network payment to be considered by the legislature before the March 1 deadline for the balance billing ban. The stakeholder process deadlocked with opposition from the insurance industry. At no time did the formal stakeholder process and its final report consider the payment formula advanced by the physician groups in the legislation.

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Anthony Simonetti, MD, FCAP

Each month, STATLINE features one of the many CAP members who are champions for pathology in Washington and at the state level through our grassroots and PAC programs. This month, STATLINE caught up with Anthony Simonetti, MD, FCAP, who is the chair of Pathology and Laboratory Medicine at Tower Health-Reading Hospital in West Reading, Pennsylvania. If you would like to get involved, you can join PathNETcontribute to PathPAC, or join your state pathology society.

How did you first get involved in advocacy?

The CAP introduced me to advocacy when I joined as a resident, by underscoring its importance and providing a foundation. Perhaps I am dating myself, but I was first involved in the CAP’s key contact program in the 1990s. At the time, my pathology group supported these activities, and senior pathologists in the practice encouraged me to get involved. I was also a member of the Young Physicians Section of the American Medical Association and later joined the CAP House of Delegates. I now serve on the board of PathPAC, our specialty’s political action committee.

Do you have a favorite memory or experience that stands out in your advocacy work?

My favorite memory is from participating in the Policy Meeting and Hill Day for the first time. I wanted to get back into advocacy after taking a break to avoid a conflict of interest issue, and this seemed like a good way to do that. It was a great feeling to be a part of the democratic process and to visit our elected officials and advocate for patients and our specialty.

What was your greatest fear or concern about becoming an advocate for the profession before you got involved? Was your fear/concern justified?

Initially, visiting senators and representatives can be intimidating, for fear of being blindsided by a question I did not know the answer to. In reality, we are the experts and the CAP’s preparation was professionally done and thorough. After Hill Day, I felt ready to meet and introduce myself to my congressman, Rep. Ryan Costello, at a local fundraiser. I am new to the district, and Rep. Costello serves on the House Energy and Commerce Committee, which oversees many CAP issues. At the event, I thanked him for cosponsoring the Local Coverage Determination Clarification Act (HR 3635/S 794), one of the CAP’s key legislative priorities. I also had a chance to introduce myself to his staff and to network with others in my community, including a local politician and a dermatologist who serves on their association’s PAC board.

Register Today.

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Donald Karcher, MD, FCAP

Wednesday, April 4, 2018 1:00 PM ET/ Noon CT

If you are one of the many pathologists concerned about practice or patient care implications from emerging policies and regulations, join us in this 60-minute webinar to learn the most effective ways you can ensure your voice is heard in Washington on issues that matter to you.

Gain insight on best practices and understand the difference you can make by engaging with your colleagues in protecting scope of practice and the quality of care for patients.

Joe Saad, MD, FCAP

Already registered to attend this year’s Policy Meeting? This is a great webinar for CAP members who are attending the Policy Meeting, especially those attending for the first time, as you’ll gain a general understanding of grassroots advocacy before you arrive in Washington.

Whether you are DC bound or looking to get involved in your district, you’ll want to hear from experienced advocates Donald Karcher, MD, FCAP, Chair of the Committee of Government and Professional Affairs, Joe Saad, MD, FCAP, Federal and State Affairs Committee Chair, and moderator Michael Giuliani, CAP Advocacy Senior Director.

Register Today.

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