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March 31, 2015

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The CAP urged the Medicare contractor Noridian to rescind a draft local coverage determination (dLCD) on special histochemical stains and immunohistochemical (IHC) stains because base evidence is unsubstantiated and the policy encroaches on pathologist medical judgment.

"Most concerning, the dLCD seems to approach the patient's diagnostic evaluation in an arbitrary fashion, potentially adversely affecting not only the efficiency with which care is delivered, but also diagnosis, clinical decisions, and treatment options," the CAP stated in a letter to Noridian. "In some instances, services deemed not necessary under the dLCD are performed to improve diagnostic turnaround time which may be lifesaving. In other instances, the dLCD's provisions could direct pathologists to practices that predispose misdiagnosis, denying patients services from which they may benefit or subjecting them to harmful and unnecessary interventions, particularly in regard to some difficult-to-diagnose malignancies."

The CAP has vigorously opposed the LCD, which was first proposed and finalized by the Medicare contractor Palmetto GBA with little revision despite the CAP’s well-supported comments pointing out specific evidentiary flaws based on the feedback of over 40 pathologist experts. The LCD was implemented in Palmetto's jurisdiction 11, consisting of North Carolina, South Carolina, Virginia, and West Virginia on March 16. The CAP continues to advocate for the policy’s withdrawal.

Noridian has proposed the same LCD for two Medicare jurisdictions and gathered public comments on the policy. If adopted, the coverage policy would affect Medicare beneficiary services in Alaska, Arizona, California, Hawaii, Idaho, Montana, North Dakota, Nevada, Oregon, South Dakota, Utah, Washington, and Wyoming.

The proposal 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.

In many instances, the CAP's experts have found areas in the draft LCD 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 dLCD, on the other hand, comprises assertions about the expected utilization of special stains over the course of time as might be seen on a retrospective analysis of aggregated claims," the CAP said. "This is of no practical use to a pathologist at the point of making any particular diagnosis or determining the billable service(s) for an individual patient. It is also of no practical use to a MAC in adjudicating individual claims. Moreover, LCDs are intended to define when a service is reasonable and necessary whereas the dLCD describes 'scenarios that might be driving medically unnecessary over utilization.'"

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Further consideration of legislation to repeal Medicare's sustainable growth rate (SGR) and implement a CAP provision addressing quality initiatives will continue once the Senate returns to Washington on April 13.

After the House overwhelmingly passed the Medicare Access and CHIP Reauthorization Act (HR 2) on March 26, Senate leaders said a vote on the bill would occur after a two-week recess. The delay means Congress would miss the SGR's April 1 deadline when Medicare rates will be cut by 21%.

However, the Centers for Medicare & Medicaid Services (CMS) is required to hold electronic claims for services for 14 days. In previous years when Congress has missed a deadline, the CMS has used the claims hold to avoid processing Medicare services at the reduced SGR rate. The hold allows for additional time for Congress to finish work on the legislation.

The CAP applauded the House for its passage of HR 2, which included the CAP secured language that gives pathologists much needed flexibility in Medicare's quality initiatives. The CAP language is tied to a new Merit-based Incentive Payment System (MIPS) in the bill. The CAP provision would give the Secretary of Health and Human Services the flexibility to develop measures and activities for pathologists, and other physicians that don't have direct interaction with patients, to enable them to comply with Medicare's quality requirements under the new MIPS incentive program.

The bill increases pay rates for physician services by 0.5% for the final six months of 2015 and then an additional 0.5% each year through 2019. The bill also provides financial incentives for providers participating in alternative payment models such as Accountable Care Organizations.

HR 2 did not include the closing the self-referral loophole protecting physicians who refer anatomic pathology (AP) services to laboratories in which they own or in which they have a financial interest, as a means of partially offsetting the $200 billion cost of the bill. The CAP, along with its Alliance for Integrity in Medicare (AIM) partners, continues to call on Congress to close the self-referral loophole.

The White House has stated that President Obama would sign the SGR-repeal bill once it reaches his desk. The president has called for repealing the SGR in his annual budgets.

"A cut of this magnitude could reduce access to physicians for Medicare beneficiaries throughout the country," according to a March 25 Statement of Administration Policy. "HR 2 would replace this system with one that offers predictability and accelerates participation in alternative payment models that encourage quality and efficiency. The proposal would advance the Administration's goal of moving the Nation's health care delivery system toward one that achieves better care, smarter spending, and healthier people through the expansion of new health care payment models, which could contribute to slowing long-term health care cost growth."

The CAP will continue to keep members informed on the latest SGR developments through STATLINE.

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The College and the Illinois Society of Pathologists (ISP) successfully defended against an attempt to undermine the recently enacted Illinois anti-markup law through changes to statutory language.

A state house representative had proposed a bill to adversely amend the public law prohibiting the markup of anatomic pathology services. The anti-markup measure was enacted in December 2014 after the Illinois General Assembly voted to override former Gov. Pat Quinn's amendatory veto.

Following extensive discussions between the sponsor and pathologists and the Illinois State Medical Society, the bill (HB 3209) was withdrawn from consideration by the sponsor before a scheduled committee hearing on the bill was to occur.

The ISP had communicated in writing to the legislative sponsor that: "In our view, the only apparent purpose of this legislation is to reverse last year's 3/5 majority over-ride vote of the State Legislature."

Legislative efforts by opponents to these laws to repeal or adversely modify direct billing and anti-markup laws have been defeated by the CAP and state pathology societies every time they have been attempted. The efforts highlight the CAP's required legislative vigilance in ensuring that these 26 state laws are not overtly nor surreptitiously amended for deleterious purposes.

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Legislation to fix New Mexico law on genetic testing has passed the State Legislature and now awaits Gov. Susana Martinez' signature.

The "Informed Consent for Genetic Testing" bill (HB 369) would remedy state statute by specifically allowing laboratories to conduct genetic testing and retain DNA samples upon the orders of a health care practitioner. Prior law disallowed such actions without the patient's specific informed consent. The change would be consistent with CAP policy and has the support of the New Mexico Society of Pathologists (NMSP).

The bill passed both houses unanimously.

"Genetic testing has become an integral part of patient care, particularly in the diagnosis and treatment of cancer," wrote NMSP President Michael J. Crossey in a March letter to Gov. Martinez in support of the legislation. "The requirement that laboratories obtain a separate informed consent for medically necessary genetic testing is often burdensome to the laboratory and confusing to the patient given there is written order from their healthcare provider. The requirement can result in delays in diagnosis and treatment."

The CAP will keep members informed on the latest developments regarding this legislation in future editions of STATLINE.

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