College of American Pathologists

  STATLINE — CAP’s Biweekly Federal and
  State Advocacy E–Newsletter

March 27, 2014  •  Volume 30, Number 7
Next Issue: April 10, 2014
© 2014 College of American Pathologists

2014 CAP Policy MeetingIn This Issue:

CAP Opposes 1-Year SGR Patch

The CAP opposed a temporary fix to Medicare’s flawed sustainable growth rate (SGR) formula in a March 27 letter to House leaders. The new legislation would fail to repeal the SGR permanently, while also neglecting critical Medicare reforms such as closing the self-referral loophole, the CAP said.

The House approved the temporary SGR fix, the Protecting Access to Medicare Act of 2014 (HR 4302), by a voice vote on March 27. The CAP, American Medical Association, and state and specialty medical societies actively opposed the bill. The legislation now moves to the Senate.

Before the House vote, the CAP had firmly stated its opposition to the bill in the letter to House Speaker John Boehner (R-OH) and Minority Leader Nancy Pelosi (D-CA). The CAP identified payment cuts and other sections in the bill that would affect pathologists negatively.

“The patch expands CMS’ authority under the ‘misvalued code’ initiative to make devastating cuts to payments for anatomic pathology services, which 113 House members opposed in a letter to the CMS Administrator in September 2013,” the letter stated. “Further, it pays for the short term patch by creating targets for spending cuts that would, over time, erode the long-term stability of the physician payment pool.”

The legislation also would significantly alter the Clinical Laboratory Fee Schedule (CLFS). While there are opportunities to improve CLFS, the impact of HR 4302 is not fully understood. The CAP urged the Congress to give pathologists sufficient time to review the sweeping changes before voting the bill into law.

Better Policy in Permanent SGR Repeal Bill

The CAP maintains its support for legislation that repeals the SGR permanently and gives pathologists options for participating in Medicare pay-for-performance programs. The Medicare Physician Quality Reporting System (PQRS), Value-Based Modifier (VBM) and Meaningful Use programs, do not capture the many contributions pathologists add to patient care and the health system. For instance, pathologists ensure the quality and safety of laboratories, blood banks, and hospitals.

The SGR Repeal and Medicare Provider Payment Modernization Act of 2014 (HR 4015) eliminates the SGR and contains the bipartisan provision addressing pathologist participation in Medicare quality programs. The bill addresses the CAP’s long-held concerns that such quality initiatives were designed for office-based physicians and are problematic for pathologists practicing in the laboratory.

HR 4302 does not include the CAP-supported provision in HR 4015. And, it does not close the self-referral loophole, which would save an estimated $6 billion over the next ten years.

“The proposed patch legislation would not provide stability for physician payments, fails to address the abuse of the self-referral loophole, would not address pathologists’ specific concerns with participation in the current pay-for-performance program, and would drastically alter the payment system for clinical laboratories without giving stakeholders adequate opportunity to engage with policymakers,” the CAP letter stated.

“For all these reasons the CAP believes it’s essential that a permanent fix be implemented and that the legislation include explicit language to address these issues.”

CAP Engages With UnitedHealthcare on IHC Policy

The CAP is engaged with the insurance carrier UnitedHealthcare regarding its new billing policy that severely affects processing of claims for immunohistochemistry (IHC) services.

The CAP began discussions with UnitedHealthcare in early March regarding its policy that establishes the maximum frequency per day for services, including IHC. The insurer has stated it lowered the number of units for IHC code 88342 effective January 1, 2014, based on its understanding of the 2014 American Medical Association Current Procedural Terminology (AMA CPT) code descriptor. United will now only pay one unit per patient, per day, of the IHC code 88342 unless claims are submitted with modifiers -59 or -91. The CAP has stated that this is an incorrect interpretation of CPT guidelines for the service, and it is working with United to address.

AMA CPT states 88342 is billed for each separately identifiable antibody per block, cytologic preparation, or hematologic smear; first separately identifiable antibody per slide.

STATLINE will publish more information as it becomes available through the CAP’s engagement with United.

CAP Advocates for KRAS/NRAS Test Coverage

The CAP urged the Medicare administrative contractor Palmetto GBA (J11; NC, SC, VA, and WV) to cover both KRAS and NRAS tests for colon cancer patients who are candidates for anti-EGFR therapy. Palmetto’s recently released draft coverage decision denied payment for NRAS testing. The CAP regularly provides expertise to Medicare contractors and commercial payers to ensure that they incorporate the latest clinical data when making coverage decisions affecting pathology services.

In a February 24 letter, the CAP commented on draft Palmetto coverage guidelines for the tests used when treating patients with colorectal or thyroid cancer. NRAS test results play an important part in the treatment options for patients with colorectal cancer, the CAP stated. Mutations in certain codons of NRAS predict non-responsiveness to anti-EGFR agents such as cetuximab and panitumumab.

The National Comprehensive Cancer Network (NCCN) has recently updated its guidelines to include NRAS testing. The CAP stated that Palmetto’s coverage policy should reflect this change.

“In this case, the preliminary coverage decision appears to have been based on older data, and did not take into account addition to the NCCN guidelines,” said Roger D. Klein, MD, JD, FCAP, a molecular pathologist at the Cleveland Clinic. “CAP appreciated the opportunity to comment and help educate the contractor about the latest information relating to the clinical usefulness of NRAS testing.”

“NRAS test results play an integral part of the treatment options for patients with metastatic colorectal cancer (mCRC),” the CAP letter stated. The CAP recommended the draft coverage decision be modified to expand coverage to include NRAS testing in patients with mCRC.

CAP Conveys Concerns with CMS

Members of the CAP’s Economic Affairs Committee met with the CMS’ Coverage and Analysis Group. The group is responsible for Medicare’s national coverage decisions and oversight of the MolDx program for molecular pathology tests.

The meeting was in follow up to an October 2013 letter from the multi-stakeholder group and a December 2013 meeting with CMS Deputy Administrator Liz Richter. During the March 20, the CAP was joined by officials from the Association for Molecular Pathology, American College of Medical Genetics, American Medical Association, National Fragile X Foundation, and Wilsons Disease Association.

CMS officials are considering potential changes to the coverage process for molecular pathology tests. Furthermore, Congress has proposed changes to the Clinical Lab Fee Schedule, which could affect coverage and payment for some molecular pathology tests in legislation that addresses the SGR. The CAP also is engaged with lawmakers to discuss the impact of such changes.

Join Your Colleagues at the CAP Policy Meeting

The CAP Policy Meeting is the only national policy meeting for pathologists, making it an essential event for anyone interested in learning about emerging policy trends from nationally recognized experts.

The 2014 CAP Policy Meeting is available exclusively to members of the CAP.

This year’s event will focus on:

  • Adopting and implementing new payment and delivery models
  • Driving value through more efficient use of health care resources
  • Tackling the workforce challenges facing pathology

The stakes have never been higher. Register for the meeting to learn about issues and advocate for pathology personally at our CAP Hill Day on May 7.

FDA Panel Recommends HPV Screening Test for Approval

A US Food and Drug Administration (FDA) panel has recommended approval of an application to grant a first-line indication to an in vitro diagnostic for human papillomavirus (HPV) testing when used as primary screening for cervical cancer.

The CAP provided comments to the FDA Microbiology Devices Panel during a March 12 meeting, where testimony on the application for the expanded indication for the Roche cobas HPV test was heard. As a member of the Cytotechnology Education and Technology Consortium, the CAP presented its concerns about the potential impact on the safety and efficacy for cervical cancer screening if the FDA approved HPV primary screening. The concerns include the identification of HPV negative cervical cancers and the triage of high-risk, HPV-positive patients.

The FDA panel ultimately approved the expansion of the indication, noting that the benefits would outweigh the risks. The panel’s vote was unanimous. It also was noted that the panel believes there are better methods than cytology. The recommendation is nonbinding, but the FDA will consider the panel’s advice during agency review.

The CAP is committed to preventing cervical cancer and working to ensure quality testing for cervical cancer screening for women. The Pap test has been one of the most effective tools to prevent cervical cancer; but the CAP recognizes as technology improves, new technology with supporting evidence should be integrated into screening paradigms to ensure the best chances for early diagnosis of cervical cancer.

Congressman Upton Tours Western Michigan Laboratory

Discussing the SGR and self-referral issues with pathologists, House Energy and Commerce Chairman Fred Upton (R-MI) toured the Western Michigan Pathology Associates laboratory at Holland Hospital and spoke with pathologists on March 18.

Western Michigan Pathology Associates President Edward P. Fody, MD, FCAP, led Rep. Upton’s tour, which lasted about an hour. Dr. Fody demonstrated how the laboratory uses automation for anatomic pathology services—ensuring patients and physicians receive quick turnaround times for tests.

The tour also included a conversation with Congressman Upton. They discussed important health care issues, such as repealing the SGR and closing the self-referral loophole.

Host Your Own Lab Tour

Dr. Fody encouraged CAP members to get involved in hosting congressional representatives for a laboratory tour.

“It’s easy, fun, and important,” Dr. Fody said. “The CAP DC office works with congressional staff to set up the tour. Our representatives are very interested in our work; they ask a lot of good questions, and it is fun to show them around.

“And, finally, it’s important because we need pathologists speaking with members of Congress. This is a chance to establish an ongoing dialogue,” Dr. Fody said.

For information about leading a tour with your representatives, watch this PathNet video. Contact Laura Brigandi if you have questions or need more information about leading a tour.

California Legislation Would Curb Self-Referral

A California state senator introduced legislation that would prohibit self-referral of anatomic pathology services.

The bill (Senate Bill 1215), introduced on March 24 by State Senator Ed Hernandez, would end self-referral of “advanced imaging, anatomic pathology, radiation therapy, or physician therapy for a specific patient performed within a licensee’s office or the office of the group practice.” Senator Hernandez chairs the State Senate Health Committee.

The legislation seeks to amend the existing California law regulating referrals and currently makes it a crime for a licensed healing arts provider to refer patients for specified services if the licensee or his or her immediate family has a financial interest with the person or entity providing the service.

The preamble to the legislation states that “recent studies by the Government Accountability Office (GAO) examining self-referral practices in advanced imaging and anatomic pathology determined that financial incentives were the most likely cause of increases in self-referrals.” The preamble also notes that “for anatomic pathology the GAO found that ‘self-referring providers likely referred over 918,000 more anatomic pathology services’ than they would have if they were not self-referring, costing Medicare approximately $69 million more in 2010 then if self-referral was not permitted.”

The PQRS Information Pathologists Need

Register for the CAP’s upcoming webinar, “PQRS: What You Need to Know (and Do!) in 2014,” on Monday, March 31, at 2:00 PM ET.

The webinar features the CAP’s Economic Affairs Committee experts who will advise you on how to earn 2014 Physician Quality Reporting System (PQRS) incentives and prevent future Medicare penalties. The webinar is free to CAP members.

As a result of the CAP’s advocacy, the CMS has promised not to penalize pathologists who have no PQRS measures that apply to their practice. But to confirm that you’re eligible for this exemption, you must act.

The webinar will discuss who is and is not at risk of the PQRS penalties, as well as how to confirm which PQRS measures apply to your practice.

Register today for “PQRS: What You Need to Know (and Do!) in 2014.”


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