College of American Pathologists

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March 13, 2014  •  Volume 30, Number 6
Next Issue: March 27, 2014
© 2014 College of American Pathologists

2014 CAP Policy MeetingIn This Issue:

CAP to Congress: Repeal the SGR, Support Bill That Improves Medicare

Legislation to repeal the Medicare sustainable growth rate (SGR) formula is expected to pass the House of Representatives this week, but offsets used to pay for the cost of the bill already have drawn opposition in the Senate.

The SGR Repeal and Medicare Provider Payment Modernization Act of 2014 (HR 4015) offers a provision backed by the College of American Pathologists (CAP) that provides more flexibility for pathologists to meet requirements under Medicare’s quality programs, such as the Physician Quality Reporting System (PQRS) and electronic health record meaningful use requirements. 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.

Repealing the SGR and making other program reforms to Medicare would cost $138 billion, according to the Congressional Budget Office. In a list of offsets, House Republicans have proposed paying for the bill by delaying the Affordable Care Act’s individual mandate requiring Americans to have health insurance. The delay would yield savings because fewer Americans would obtain health insurance and need federal premium subsidies. Senate Democrats and the White House have said the offset is unacceptable.

If the bill stalls in the Senate, Congress is expected to delay the 24% SGR cut that will reduce physician Medicare rates after March 31. Congress has delayed the SGR 16 times since 2003. How long the delay could last was uncertain at this article’s deadline.

The CAP is hopeful a bipartisan agreement on offsets can ultimately be reached so that the House, Senate, and White House can advance and enact a permanent repeal.

The CAP has continued to urge lawmakers to repeal the SGR permanently. On March 5, CAP members demonstrated support HR 4015, and a Senate version of the bill, by writing and calling their representatives in Congress. Members can visit the CAP Action Center for more information on how to contact lawmakers.

Budget Request to Congress Closes Self-Referral Loophole, But Also Cuts Clinical Laboratory Pay

President Obama’s spending plan for fiscal year 2015 recommends excluding anatomic pathology (AP) services from the In-Office Ancillary Services (IOAS) exception to the Stark Law. Closing this self-referral loophole in the president’s budget reflects years of advocacy work by the CAP against the ongoing inclusion of AP services in the IOAS exception as it does not benefit patient care.

The 2015 budget is the first time the president called for the removal of AP services from the IOAS exception. The president’s budget also recommends removing advanced imaging, radiation therapy, and physical therapy services from the IOAS exception. Budget officials estimate removing these services would yield $6.03 billion over 10 years in Medicare savings.

“While there are many appropriate uses for this exception, certain services, such as advanced imaging and outpatient therapy, are rarely furnished on the same day as the related physician office visit,” President Obama’s budget states. “Additionally, there is evidence that suggests that this exception may have resulted in overutilization and rapid growth of certain services.”

Congress Still Must Act on Self-Referral

The CAP applauded the president’s 2015 budget, which serves as a platform for the administration to negotiate with Congress on the budget. The CAP is urging lawmakers to enact legislation that would make the president’s proposal law. The CAP supports passage of the Promoting Integrity in Medicare Act of 2013, which has been introduced by Rep. Jackie Speier (D-CA). The bill would remove AP, physical therapy, advanced diagnostic imaging, and radiation oncology from the list of services that may be self-referred under the current exception.

Laboratory Fee Cuts in 2015 Budget

While the president’s budget takes the right step toward closing the self-referral loophole, the spending plan also would reduce payment rates under the Medicare Clinical Laboratory Fee Schedule (CLFS) by -1.75% from 2016 through 2023. President Obama had proposed the same cut in his budget the previous year.

The reduction to the CLFS first was included in the Affordable Care Act, and it is set to expire in 2015.

Proposal Redirects Medicare Funds for GME Residency Slots

The College is concerned about proposed changes to graduate medical education (GME) funding, which would cut roughly $15 billion, or 10% beginning in 2015, in Medicare Indirect Medical Education.

The budget calls for $5.2 billion in mandatory GME funding over 10 years for a new competitive grant program to teaching hospitals, children’s hospitals, and community-based consortia of teaching hospitals or other entities. The program would focus on primary care.

Additionally, the Health and Human Services Secretary “would be granted the authority to set standards for teaching hospitals receiving Graduate Medical Education payments to encourage training of primary care residents and emphasize skills that promote high-quality and high-value health care.” The administration proposed $14.62 billion to fund three health workforce initiatives, including a $5.23 billion transfer from the Medicare Hospital Insurance Trust Fund to establish a new graduate medical education grant program at the Health Resources and Services Administration (HRSA), a $3.9 billion funding increase for the National Health Service Corps, and $5.4 billion to extend the Medicaid “payment floor” for primary care services.

The College has made significant progress to address the workforce challenges ahead. The CAP’s leaders have worked to significantly increase the CAP’s presence and visibility in GME policy circles, making pathology’s case with key policy stakeholders such as the federal Health Resources and Services Administration and the Association of American Medical Colleges. New investments in graduate medical education should not be funded through other cuts to GME; and while there is an urgent need to increase the primary care workforce, increased funding for residency training is also needed for the pathology workforce.

US District Court Denies Myriad Preliminary Injunction Against Ambry

A federal judge in Utah denied a preliminary injunction by Myriad Genetics, which sought to stop Ambry Genetics from providing BRCA1 and BRCA2 tests during pending litigation.

“The court concludes Plaintiffs are not entitled to the extraordinary remedy of a preliminary injunction to halt Defendant from selling its own BRCA1 and BRCA2 genetic tests,” wrote US District Judge Robert J. Shelby in his March 10 decision. “Although Plaintiffs have shown that they are likely to suffer irreparable harm through erosion of their test pricing structure, loss of their share of the testing market, and loss of their exclusive patent terms if an injunction does not issue, Defendant has raised a substantial question concerning whether Plaintiffs’ Primer and Method Claims are directed toward patent-eligible products of nature and abstract ideas under 35 U.S.C. § 101.”

Genomic medicine achieved a major victory in June 2013 when the Supreme Court, in Association of Molecular Pathology et al, vs Myriad Genetics, Inc., invalidated the patents held by Myriad Genetics on the BRCA1 and BRCA2 genes on the grounds that human genes are products of nature and therefore ineligible to be patented.

The CAP has long opposed the issuing of gene patents and was a co-plaintiff in the Supreme Court case. The landmark unanimous decision invalidated patents held by Myriad on genomic DNA, but upheld patents on cDNA, with the caveat that cDNA patents may not be patent eligible where the cDNA is indistinguishable from natural DNA.

The day after the decision, Ambry Genetics launched a BRCA product line. Myriad then sued Ambry and filed a preliminary injunction to stop them from offering the genetic services.

The CAP’s Personalized Health Care Committee chair and Council on Government and Professional Affairs member, Debra G.B. Leonard, MD, PhD, FCAP, and the CAP provided a joint declaration statement in support of Ambry.

“The CAP has had a policy opposing gene patents for over a decade,” the statement said. “Under CAP’s longstanding policy, CAP affirms that gene patents used to prevent physicians and clinical laboratories from providing gene-based diagnostic test services limit access to medical care, jeopardize its quality, and raise its costs.”

The judge’s ruling in the Ambry case allows the company to continue offering its BRCA-related genetic testing products while the lawsuit is pending.

CAP Policy Meeting Sparks Pathologists to Get Involved

The annual CAP Policy Meeting first sparked Michael J. Misialek, MD, FCAP, into becoming more active on advocating for his patients and his specialty in the political and health policy arenas.

“This is an invaluable experience that everyone should take advantage of,” Dr. Misialek, a Newton, Massachusetts, pathologist, said about the CAP Policy Meeting. “Here I learned in depth about the issues we face. I gained the skills and tools important in lobbying and learned how to deliver that ‘elevator speech.’ I discovered that one person can make a difference.”

And, Dr. Misialek has made a huge difference for his specialty by using the skills he acquired from the meeting. Recently, he hosted a fundraiser for Rep. Joe Kennedy III (D-MA) after meeting with him at his district office and later providing a tour of the Newton-Wellesley Hospital Pathology Department laboratory.

The fundraiser was a big success with about 20 pathologists attending. Many of Dr. Misialek’s colleagues appreciated the opportunity to meet Rep. Kennedy and were impressed with the congressman’s knowledge of the issues. The event demonstrated pathologists and the CAP are united on confronting the challenges ahead.

Register for the Policy Meeting Today

Join your colleagues at the 2014 CAP Policy Meeting, May 5-7, 2014, in Washington, DC. Focus on the issues most important to pathologists now and in the future. Prepare yourself for what’s ahead and advocate on behalf of pathology on Capitol Hill. For pathologists, there’s no other meeting like it.

Expansion of Medicare Physician Compare Draws CAP Concerns

The CAP has urged the CMS to allow pathologists enough time to review data on performance in Medicare quality programs before such information is posted online in order to ensure accuracy.

The Medicare statute required the CMS to create and maintain the Physician Compare website to help Medicare beneficiaries select physicians. Most patients do not select their pathologists, but the specialty is included in the online directory along with all physicians participating in Medicare.

The CMS has proposed providing physicians the opportunity to review and correct information about them prior to publication on Physician Compare. Reducing the timeframe for review of 30 days to two weeks would be too short, the CAP stated in a March 3 letter to the CMS. More time would be needed as a recent poll of CAP members showed half of the entries were inaccurate or incomplete, the College stated.

The CAP has questioned the accuracy of the website in the past. The Department of Health and Human Services (HHS) Office of Inspector General (OIG), which protects the integrity of federal health programs, also is planning to release a study on Physician Compare in 2014.

“In particular, some entries did not note participation in the PQRS when the member had participated,” the CAP stated. “Our member experience reinforces the importance of the ongoing HHS OIG study on the accuracy of Physician Compare data. Accurate information should be the first and highest priority before any additional information is considered for the site.”

The CAP further urged the CMS to develop educational tools for patients using Physician Compare. Categories, such as electronic prescribing and the Physician Quality Reporting System, may not apply and the absence of information could be misleading to patients. The CMS must indicate when programs do not apply to physicians, the CAP said.

In addition to the letter, the CAP also participated in a Medicare Town Hall on Physician Compare on February 24, raising the visibility of the concerns cited in the CAP’s comments.

How to Correct an Inaccurate Profile

The CMS offers instructions on how to correct inaccurate or incomplete information already available online. The Medicare enrollment system—Provider Enrollment, Chain, and Ownership System (PECOS)—is where physicians can correct practice locations, phone numbers, and Medicare assignment status.

Physicians can update their training, residency, hospital affiliation, and foreign language skills by emailing the Physician Compare at The CMS asks physicians to include the correct information along with a name, specialty, practice locations, National Provider Identifier (NPI), and contact information when submitting a correction.

Louisville Laboratory Welcomes Congressman Massie

Pathologists at CPA Laboratory in Louisville, Kentucky, recently provided Rep. Thomas Massie (R-KY) with a tour of their facility and discussed health care-related issues such as repeal of the Medicare SGR.

The tour consisted of walking Congressman Massie through the steps required to transform a patient’s biopsy into histologic sections that can be used to diagnose cancer, said Rebecca Christensen, MD, FCAP, who organized the event. They then examined a slide of breast cancer tissue through a multiheaded scope and reviewed some of the histologic features of this diagnosis—contrasting it with normal breast tissue. They also discussed the role of ancillary testing, such as immunohistochemistry and FISH HER2 analysis, and how treating physicians use this information.

In addition to repeal of the SGR, members of the laboratory discussed legislation to close the Stark self-referral loophole that allows physicians to refer anatomic pathology services to laboratories in which they have a financial interest.

“I believe he left our laboratory with a much broader understanding of laboratory medicine and the role a pathologist plays in directing a patient’s care,” Dr. Christensen said.

Leading the tour was Dr. Christensen; Alvin Martin, MD, FCAP, CPA Medical Director; Mabel Scherzer, AVP, CPA Operations; Sameer Talwalkar, MD, Head of Molecular Pathology Lab; Sheron Lear, HT(ASCP) HTL, QIHC, Histology Supervisor; and Shanna Pollock, MSB, HTL(ASCP)QIHC, PA.

Congressman Massie has posted pictures of the tour on his Facebook page.

How to Host Your Own Lab Tour

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.

Concerned About Payment Penalties? Register for CAP Webinar on PQRS

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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