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The CAP requested that House lawmakers consider the College's proposal to establish a regulatory framework for laboratory-developed tests (LDTs) oversight in order to protect patient safety, allow for continued innovation in diagnostic medicine, and not add regulatory burdens to laboratories.

A June 19 letter signed by CAP President Gene N. Herbek, MD, FCAP to the House Energy and Commerce Committee detailed the College's concerns with a legislative draft for LDT oversight. The proposal would create an entirely new, complex regulatory framework that increases burdens on laboratories. "The CAP believes that such an approach is unnecessary to ensure appropriate oversight of LDTs," the letter said.

"As you know, the CAP has advocated for its longstanding proposal to serve as a template for any regulatory oversight of LDTs," Dr. Herbek wrote. "The CAP respectfully requests the committee to consider our approach as a substitute for any legislative proposal."

Read the entire letter to the Energy and Commerce Committee.

The CAP has been actively engaged in these discussions on LDT oversight with the Congress, Centers for Medicare & Medicaid Services (CMS), and the Food and Drug Administration (FDA). The CAP continues to press the CAP’s 2009 LDT proposal as the best framework for the Congress and administration to move forward should they ultimately decide to legislate on the issue.

In the letter, the CAP disagreed with the draft concept that all LDTs must go through the FDA as devices that laboratories could no longer develop low- or moderate-risk LDTs outside of the FDA’s authority. "This is an unnecessary hurdle laboratories can provide quality laboratory testing under CLIA, particularly for low- and moderate-risk LDTs where pathologists perform laboratory operations and develop LDTs," the CAP said. "For laboratories that perform these activities, this provision creates an unnecessary regulatory burden that is better addressed through the existing CLIA process."

Draft legislation would expand certification and standards for subspecialties and develop new standards for genetic tests in the context of a LDT regulatory framework. The CAP believes this is unnecessary and adds additional regulatory burden.

The CAP also objected to a provision that codifies the practice of medicine at the federal level. The CAP believes the practice of medicine should remain under the jurisdiction of individual states and asked that the provision be removed.

"The CAP is concerned that the current draft is unnecessarily complex and burdensome to laboratories and that our proposal offers a simplified yet practical and balanced risk-based approach for clinical laboratories to provide accurate and reliable test results for clinicians and patients," the letter stated. "The CAP requests that the committee reconsider its draft legislative approach as the CAP cannot support the draft proposal as currently written."

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The CAP is opposing the Medicare Administrative Contractor (MAC) First Coast Service Options, Inc., proposal released last week to adopt a local coverage determination (LCD) policy on special histochemical stains and immunohistochemical (IHC) stains.

The CAP will urge First Coast, which provides Medicare administrative services in Florida and territories of Puerto Rico and US Virgin Islands, to withdraw the LCD. The LCD is similar to one first proposed and finalized by the Medicare contractor Palmetto GBA. Palmetto has implemented the LCD with little revision despite the CAP's objection and well-supported comments pointing out specific evidentiary flaws based on the feedback of over 40 pathologist experts. The Palmetto LCD affects beneficiaries and providers in North Carolina, South Carolina, Virginia, and West Virginia.

The CAP continues to advocate for the policy's withdrawal. The College maintains that evidence purported to support the LCD is unsubstantiated and the policy encroaches on medical judgment.

The Medicare contractors Noridian and CGS also have proposed the same LCD. The CAP submitted comments opposing the Noridian LCDs and will send formal comments opposing the CGS LCD by an August 3 deadline. If adopted, the coverage policy would affect Medicare beneficiary services in Noridian's jurisdictions representing Alaska, Arizona, California, Hawaii, Idaho, Montana, North Dakota, Nevada, Oregon, South Dakota, Utah, Washington, and Wyoming. CGS oversees the Medicare program in Kentucky and Ohio.

In general, the LCD is broad, covering nine clinical areas including breast, gastrointestinal, lung, urogenital, and skin disorders. It would require pathologists to first review hematoxylin and eosin stain prior to ordering special stains in many instances.

The CAPs experts have found areas in the coverage policy that are directly contradicted by medical literature. The LCD also attempts to set coverage criteria in areas of pathology when no consensus has emerged and with terms that cannot be practically applied.

The CAP will continue to keep members informed on the latest developments on this issue in future editions of STATLINE.

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While early examples of accountable care organizations (ACO) focused on primary care, specialty physicians, including pathologists, are establishing significant roles in leading new patient care models that improve care experiences, population health, and patient outcomes.

At the Sixth National ACO Summit in Washington, DC, CAP member Patrick Twomey, MD, FCAP, participated on a panel discussing specialty care challenges and approaches to care coordination models on June 19. Dr. Twomey is chief medical officer and chief quality officer at Essentia Health in Duluth, MN and a member of the CAP ACO Network. Dr. Twomey was the fourth CAP member to speak at the ACO Summit in recent years. The CAP is the only specialty society member of the Brookings-Dartmouth ACO Learning Network, which hosts the summit.

"It's not all about cost reduction or being the gatekeeper in laboratory medicine," Dr. Twomey said. "It's about choosing the right tests for our patients."

The importance of improving patient safety cannot be overlooked, Dr. Twomey said. Pathologists in ACOs and other care models have a "unique lens" for improving quality care and the overall patient care experience.

Dr. Twomey praised the CAP and its members for being engaged in efforts to improve care, improve population health, and lower per capita patient costs. He referenced Donald S. Karcher, MD, FCAP, and the College's work including that of the CAP ACO Network preparing pathologists for value-based care models. CAP members who are part of an ACO or want more information about or want to join the network can email us.

Dr. Karcher, who also attended the ACO summit again this year, said pathologists in his department at the George Washington University Medical Center in Washington, DC will soon use a system that allows ordering physicians to electronically send a message to a pathologist via the electronic medical record system asking, for example, which tests are appropriate for follow-up care or anything about laboratory results received. The pathologists will provide a response within two hours. The information received will help ordering physicians improve quality of care and patient safety, Dr. Karcher said. A similar idea involving radiologists was mentioned during Dr. Twomey's panel discussion.

Some pathologists at Essentia are engaged in care coordination activities at various levels, such as attending cost of care seminars to participating on laboratory utilization boards, Dr. Twomey said. However, he said he also worries too many physicians may continue to not pay attention to new payment and care coordination initiatives.

"I think there is a tsunami coming that a lot of pathologists don't see and they are beginning to get into danger of losing relevance in the value-based world where the laboratory becomes a cost center instead of a profit center. Those days are right around the corner," Dr. Twomey said.

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A controversial and complex bill aimed at addressing out-of-network (OON) health care prices in New Jersey was held from a vote at the Senate Commerce Committee's hearing. In Texas, a new law lowers OON mediation to $500 from $1,000 after state physicians sought a compromise to avert a plan to drop the threshold to $0.

The CAP and pathologists in New Jersey and Texas objected to the state legislation addressing OON billing. The College worked with state pathology societies to oppose bills in the two states.

In New Jersey, pathologists opposed the legislation dubbed the "Out-of-Network Consumer Protection, Transparency, Cost Containment and Accountability Act" (S20/A4444). The legislation was designed to advance the insurance industry's position that their out-of-network costs need to be controlled and limited. Proponents of the bill lauded it as a consumer advocacy measure, but opponents argued the bill threatens to suppress out-of-network physicians’ ability to negotiate fair pay or does nothing to require insurance companies to pay more reasonable rates.

Pathologists opposed the bill because it sought to shift financial responsibility from the insurance payer to the patient for payment of out-of-network costs in excess of in-network coverage. Significantly, provisions of the bill would have voided the current balance billing protection afforded to patients under New Jersey insurance regulations. In addition, the legislation required physicians, including pathologists, to provide a written estimate of charges in advance of services.

Pathologists cannot defer anatomic pathology procedures based on insurance considerations, as this would potentially result in specimen degradation, detrimental delays in diagnosis, extended hospitalizations, increased costs, and diminished patient care.

On June 8, the legislation stalled and was held in Committee at the urging of pathologists and other medical specialties.

In Texas, the CAP opposed legislation (House Bill 3133/Senate Bill 481 ) to reduce the $1,000 minimum amount potentially subject to mediation under that state's out-of-network balance billing law. Patients who received a balanced bill of more than $1,000 by a facility-based, out-of-network physician, including a pathologist, could seek mediation of the bill.

Legislators proposed lowering the minimum to nothing, but a compromise supported by physicians agreed to reduce it to $500. Texas Gov. Greg Abbott signed the bill in to law on June 15.

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The American Medical Association (AMA) is asking all of its members to make sure that they vote for the national medical specialty society that best represents your specialty in the AMA House of Delegates. The CAP urges every pathologist to cast a vote for the CAP, as your support is vital to assuring pathologists have a strong voice in the House of Medicine.

The AMA HOD has over 500 voting members and includes representatives from 116 national medical specialties. Voting for CAP as your specialty society not only ensures the College's ability to lead the delegation of pathology organizations in the AMA House of Delegates, it also helps increase the number of pathologists in our delegation. For every 1,000 votes CAP receives, the specialty is allowed one additional delegate in the AMA HOD.

The AMA HOD is the policy-making arm of the AMA and additional delegates mean a stronger voice for your specialty. Once you cast your initial vote, your ballot will remain in AMA records unless you choose to vote for another society. Cast your ballot now.

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Sign up for the College's July 8 webinar "Understanding the 2016 Medicare Physician Fee Schedule Proposed Rule." Throughout this hour-long panel discussion, CAP experts will explain the changes proposed by the CMS regarding the 2016 fee schedule.

The proposed fee schedule will contain reimbursement changes affecting pathologists. During this session, attendees will learn about the proposed rule's pathology-related policies, the potential impact on pathologists, and the CAP's advocacy efforts to impact the CMS' proposal prior to its finalization.

Sign up for this complementary webinar presentation today.

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