College of American Pathologists
Printable Version

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

October 13, 2011  •  Volume 27, Number 21
Next Issue: October 27, 2011
© 2011 College of American Pathologists

In This Issue:

CAP Members Take to the Hill on Self-Referral as Lobbying Efforts Intensify
MedPAC Recommends SGR Repeal, Physician Fee Reductions to Congress
CAP Comments on FDA’s Companion Diagnostic Draft Guidance
PSA Testing Controversy Highlights Complexities of Prostate Cancer Diagnosis
CMS Official Says Whole Genome Sequencing Coverage is Unlikely
Rep. Harper (R-MS) Tours King’s Daughters Pathology Laboratory
Illinois Clarifies Potential Billing Markup Violations
Tennessee Medical Board Refines Position on Releasing Test Results
Keep Up with the Latest CAP Advocacy News on Twitter

CAP Members Take to the Hill on Self-Referral as Lobbying Efforts Intensify

This week CAP members arrived on Capitol Hill to speak with members of Congress on critical advocacy issues for pathologists—primarily the potential health care savings that could result by curbing self-referral abuses, specifically by removing anatomic pathology (AP) from the in-office ancillary services (IOAS) exception to the Stark Law.

These CAP member “fly-ins” build upon ongoing advocacy efforts by the College on self-referral, as well as other legislative priorities, including the looming 29.5% Medicare physician payment cut under SGR set to take effect as of Jan. 1, 2012, and the year-end expiration of the technical component (TC) of the grandfather provision for pathology testing services.

Extended Statline Coverage Begins Next Week

To keep CAP members updated on key advocacy developments during these important negotiations, weekly Statline alerts and updates will be published beginning next week and continuing through the end of the year.

Saving health care dollars—such as by removing AP services from the IOAS exception—is resonating right now on the Hill, CAP member Kathryn T. Knight, MD, FCAP, told Statline earlier this week when she was in Washington, DC, visiting various members of Congress on these advocacy issues. “The focus right now for Congress appears to be looking at ways to save money, and then ultimately bringing these proposals to the Joint Select Committee on Deficit Reduction,” she explained. “Because of this, Congress and their staff appear more interested in issues such as over-utilization of medical services, which we know occurs in self-referral.”

Tasked with identifying at least $1.2 trillion in savings by Thanksgiving, this Joint Committee is looking hard at entitlement programs like Medicare for cuts. Congress then has to vote on the recommended savings by the end of December. Given this tight timeline and potential impact of spending cuts on pathologists, CAP members need to take advantage of opportunities to advocate directly with their members of Congress, including participating in CAP-sponsored fly-ins such as those occurring this week and over the next several weeks, said Dr. Knight, who is Chair of CAP’s Federal and State Affairs Committee (FSAC).

“This is your College, and these are issues impacting your profession,” she urged CAP members. “You need to be involved.”

CAP members are urged to visit the PathNET Legislative Action Center to sign up for the Self-Referral Action List and find out more about the current Grassroots Fly-In. CAP members are traveling to Washington, DC, now and over the coming weeks to meet with their Members of Congress on this issue.

MedPAC Recommends SGR Repeal, Physician Fee Reductions to Congress

The Medicare Payment Advisory Commission (MedPAC) has finalized recommendations for Congress to repeal the flawed sustainable growth rate (SGR) physician payment formula.

These recommendations include replacing the repeal with a 5.9% payment reduction to specialty physicians under the Medicare Physician Fee Schedule (PFS) for each of the three initial years, followed by a freeze in payment rates for seven years. Medicare payment rates for primary care physicians would be frozen for 10 years, according to the final recommendations approved by the 17 members at the Oct. 6 meeting of the independent Congressional agency.

In addition to these recommendations, MedPAC Commissioners also offered a list of offset options, should Congress decide to offset the costs of the SGR repeal. This list includes reducing clinical laboratory service payments for 10 years, which is estimated to yield $21 billion in savings. These funding offsets were not voted on or discussed, as announced at the beginning of the meeting by Chair Glenn Hackbarth, who emphasized that the Commission was not endorsing the offsets. Rather, the offsets will be presented to Congress as options to pay for the repeal.

At the meeting MedPAC also finalized three other recommendations focused on reducing PFS expenditure growth. These include a call for the HHS to collect data to establish more accurate work and practice expense values, as well as having HHS identify overpriced PFS services and reduce their relative value units (RVUs) accordingly. Finally, MedPAC recommended that HHS increase shared savings opportunities for physicians and health professionals who join or lead accountable care organizations (ACOs).

AMA, CAP Voice Offset Concerns

The CAP, along with the AMA and other physician groups, are staunch opponents of the current Medicare SGR payment formula. However, there is concern about MedPAC’s SGR replacement recommendations that would cut physician payment rates. “We appreciate the Commission’s desire to facilitate enactment of a total SGR repeal,” stated an Oct. 3 AMA letter to MedPAC Chair Hackbarth that was signed by the College. “In view of the very significant payment constraints that physicians have already absorbed over the past decade, however, we respectfully disagree with the suggestion that SGR repeal should be funded in large part by cuts in payments to physicians.”

The CAP also recently joined the AMA and other physician groups in a letter to Joint Select Committee on Deficit Reduction Co-Chair Sen. Patty Murray (D-WA), urging for SGR repeal in the group’s final legislation. “As the Committee begins its deliberations, it is important to note that the current budget baseline assumes that massive physician payment cuts will be implemented,” stated the letter. “In fact, Members of Congress from both sides of the aisle have stated that the current law baseline does not reflect the policies that Congress has operated by in recent years. Any effort to stabilize our nation’s finances must be based on a true assessment of future expenditures.”

CAP Comments on FDA’s Companion Diagnostic Draft Guidance

FDA’s current draft guidance on in vitro companion diagnostic devices could negatively affect pathologists’ ability to provide high quality innovative tests, such as laboratory developed tests (LDTs) to patients, outlined the CAP in comments submitted to the agency on Oct. 12.

Specifically, the draft guidance fails to recognize the pathologist’s role in evaluating tumors and characterizing their biology, CAP member Jan A. Nowak, MD, PhD, FCAP, told Statline. “It’s important not to overstate exactly what these tests do in terms of making a diagnosis,” he explained. “Pathologists, not tests, determine a patient’s diagnosis, and that is not clear in this draft guidance.” Dr. Nowak contributed to the FDA comments.

Indeed, the draft guidance attempts to define a regimented approach for the approval of each companion diagnostic by tying it to every specific clinical indication and specimen type. This is unrealistic in its view of how these tests are used by the pathologist and the oncologist clinician, note the comments. “In rigorously defining and linking clinical indication, test result, and a specific therapeutic, this policy may falsely assure users that a particular test result conveys a greater level of significance than is warranted,” state the comments.

The College’s comments also focus on the FDA’s approach to therapeutic product labeling. The agency indicates that the labeling should identify a type of FDA-approved or cleared IVD companion diagnostic device (i.e., the intended use of the device), rather than a specific manufacturer’s IVD companion diagnostic device.

However, the College asserts that the label should indicate the biological pathway or target of testing, rather than a specific test or test process. Furthermore, the label should not restrict testing methodologies to only FDA approved or cleared devices, which would exclude LDTs. Rather, the analyte to be tested should be specified on the label. “Restricting through labeling of therapeutic products to FDA approved or cleared IVD companion diagnostic tests and their defined limitations will unnecessarily limit patient access to valuable tests, restrict pathologists’ ability to provide the most thorough evaluations for their patients, and affect coverage and reimbursement decisions,” state the comments.

PSA Testing Controversy Highlights Complexities of Prostate Cancer Diagnosis

The U.S. Preventive Services Task Force’s (USPSTF) recent draft recommendations on routine prostate cancer screening of men using the PSA blood test reignited a longstanding debate over this controversial test. Citing patient harm related to false-positive results, as well as potential overdiagnosis and overtreatment, the government panel concluded that current evidence is insufficient to assess the balance of benefits and harms of prostate cancer screening in men younger than age 75 years. The panel also recommended against screening men age 75 or older.

These recent draft recommendations, currently open for comment until Nov. 8, address many of the controversies regarding the diagnosis, treatment and natural history of prostate cancer, Thomas M. Wheeler, MD, FCAP, explained to Statline.

“PSA has never been a great marker for prostate cancer, largely because it is also elevated in common benign conditions such as benign prostatic hyperplasia and prostatitis,” said Dr. Wheeler, a former CAP Governor and current Chairman of the Baylor College of Medicine’s Department of Pathology in Houston, Texas. “When a biopsy is done solely on the basis of an elevated PSA, a substantial number of cancers detected are very small and clinically insignificant. If only one of twelve cores has a small focus of cancer, does this mean it is a very tiny cancer or is this the sampling of the tip of the iceberg?”

Given these issues, however, Dr. Wheeler believes that the USPSTF’s draft recommendations go too far and patients—particularly men over the age of 50—should be offered the test, albeit with appropriate counseling beforehand. Before predicting the full impact of how these draft recommendations will affect clinical practice, Dr. Wheeler says pathologists should wait to see how other medical societies, such as the American Urological Association (AUA) and the American Cancer Society, weigh in about revising their current guidelines.

Following the USPSTF’s announcement, AUA President Sushil S. Lacy, MD, expressed concern that these draft recommendations would do more harm than good, and that when interpreted appropriately, the PSA test provides important information in the diagnosis, treatment, and monitoring of prostate cancer patients. Dr. Lacy’s statement also indicated that the AUA is current preparing a new clinical guideline for the use of the test and early detection of this cancer through new and forthcoming diagnostic tests.

Pathologists’ Role

While Dr. Wheeler supports offering the test to certain patients, he also believes that patients need to be educated about the limitations of the PSA test; for example, to know up front that two-thirds of biopsies performed due to elevated levels are benign. Furthermore, if a patient is diagnosed with limited prostate cancer, immediate radical treatment might not be the best course of action. “If diagnosed with limited prostate cancer, patients should understand that active surveillance of the disease is often a very appropriate course of action,” explained Dr. Wheeler. “That stated, it is often very hard emotionally for some patients to contemplate living with cancer on a wait-and-see basis.”

Dr. Wheeler added that pathologists are in an ideal position to help patients and other health care providers understand the complexities of diagnosing this disease, as well as its progression. “After all, it is a laboratory test and is most commonly elevated in men with no signs or symptoms whatsoever,” he said. “Pathologists who understand the complexity of PSA testing and prostate cancer’s natural history are in an excellent position to interact directly with patients regarding an abnormal PSA test result.”

CMS Official Says Whole Genome Sequencing Coverage is Unlikely

Medicare is not likely to start reimbursing for whole genome sequencing (WGS) soon, if ever, announced Jeffrey Roche, MD, the agency’s Coverage and Analysis Medical Officer at an Oct. 5 Capitol Hill briefing, “Personalized Medicine: From Promise to Practice”, sponsored by Health Affairs and the Center for the Study of the Presidency and Congress.

In terms of evaluating personalized medicine-related tools for coverage, Dr. Roche said that the agency is looking for greater evidence of clinical utility. “We need more evidence from prospective studies about the impact that targeted therapies have on outcomes and more evidence of improved outcomes,” he said. “This is currently the situation with whole genome sequencing...I hope people realize that whole genome sequencing itself is probably something that CMS would never cover.”

FDA’s Obstacles

Also present at the briefing was FDA’s Director of Personalized Medicine Staff Elizabeth Mansfield, PhD, who spoke about the primary challenges facing the agency in advancing personalized medicine. The briefing occurred on the same day that the FDA released a new report, Driving Biomedical Innovation: Initiatives to Improve Products for Patients, outlining the agency’s strategy to drive innovative medical devices, such as personalized medicine tools, into the public health domain.

Dr. Mansfield explained that one of the main challenges for her office is that staff has to consider three different regulatory statutes when drafting guidance, such as the companion diagnostics guidance currently out for comment. “These statutes come from FDA offices dealing with drugs, biologics, and imaging, among others, that were developed before the era of personalized medicine,” Dr. Mansfield explained. “It’s challenging to weave all of these efforts together.”

Rep. Harper (R-MS) Tours King’s Daughters Pathology Laboratory

CAP member Robert B. Britt, MD, FCAP, led Rep. Harper (R-MS) on a recent laboratory tour.Republican Congressman Gregg Harper recently visited the pathology laboratory at King’s Daughters Medical Center in Brookhaven, Mississippi. The tour was led by CAP member Robert B. Britt, MD, FCAP.

Rep. Harper serves on two House Energy and Commerce subcommittees: Environment and Economy and Commerce, Manufacturing and Trade.

Tours like this recent one in Brookhaven, as well as Hill visits, are key ways that relationships develop between CAP members and members of Congress. Check out the recently posted PathNET video on CAP’s Advocacy site for more information on lab tours.

Illinois Clarifies Potential Billing Markup Violations

Physicians in Illinois who “markup” bills for pathology services that they ordered, but for which they did not perform the anatomic pathology component, could be violating certain statutory provisions, according to a Sept. 29 letter to the state pathology society from Associate General Counsel Daniel A. Kebler from the state Department of Financial and Professional Regulation (DFPR).

The letter was in response to a request from the Illinois Society of Pathologists and the CAP to the Medical Board in Illinois asking for clarification on whether physicians who order but do not provide anatomic pathology services could lawfully markup the bill for profit before sending it on to the patient or payer. The DFPR oversees the Medical Board.

“A licensee under the [Illinois Medical Practice] Act may not directly or indirectly divide, share or split any professional fee or other form of compensation for professional services...,” stated Kebler in his response. “The scenario you describe…may constitute a violation of the statutory provisions.”

Kebler goes on to say, however, that this is an informal interpretation and not intended as the state’s official opinion. However, he indicates that state officials will investigate potential violations. “If a patient or physician wishes to file a complaint with the Department regarding this type of activity, it will be fully investigated,” he stated in the letter.

Tennessee Medical Board Refines Position on Releasing Test Results

Laboratories in Tennessee now have the authority to release test results directly to patients with the ordering clinician’s authorization, according to a Sept. 16 correspondence from the Tennessee Medical Laboratory Board (TMLB), which is overseen by the state’s Department of Health (DOH).

The Tennessee Society of Pathologists (TSP), with support from the CAP, recently sought to clarify the TMLB’s position, as a previous communication from the Board indicated that laboratories may not give test results directly to a health care provider’s patient. The TSP and the CAP had concerns that the TMLB’s position appeared to prohibit the laboratory release of test results to patients even with the consent of the ordering physician, and was therefore incongruent with state law.

In response to the request for clarification, the DOH’s assistant general counsel, Diona E. Layden, elaborated on the previous communication, sent on Apr. 15. “The purpose of the…April 15 not to prohibit the release of patient test results to the patient upon authorization from the health care provider who ordered the testing, but to prohibit a laboratory from sending test results directly to a patient without the prior authorization from the healthcare provider who ordered the testing,” wrote Layden in a Sept. 16 letter to TSP President J. Cameron Hall, MD, FCAP.

This recent communication reflects the same position affirmed by the state’s Board of Medical Examiners in July 2010. The Board’s officials came to this position after considering submissions from the TSP and the CAP.

Keep Up with the Latest CAP Advocacy News on Twitter

CAP Advocacy is now on Twitter. Follow CAP Advocacy’s daily “tweets” to keep pace with regulatory and legislative news affecting the pathology industry. For the latest health care news, be sure to check out what we are following on Twitter.


202-354-7100  •  202-354-7155 (fax)  •  800-392-9994


Related Links Related Links




Customize CAP Ads with your laboratory’s logo