College of American Pathologists
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December 8, 2011  •  Volume 27, Number 25
Next Issue: December 22, 2011
© 2011 College of American Pathologists

In This Issue:

CAP Continues Hill Pressure as Time Draws Short on SGR, TC Grandfather Deadlines
CAP Hosts PQRS Webinar for Pathologists
Tavenner in “Good Position” for CMS Administrator Confirmation
Rep. Lance (R-NJ) Looks to Overhaul IVDx Approval in MODDERN Cures Act
JAMA Commentary Calls for More Research on Direct Patient Access to Test Results
OIG Advisory Opinion Scrutinizes Laboratory Mgmt Service Agreement
HHS Delays Stage 2 Meaningful Use Compliance for Early Adopters
Keep Up with the Latest CAP Advocacy News on Twitter

CAP Continues Hill Pressure as Time Draws Short on SGR, TC Grandfather Deadlines

With less than a month to go before key Medicare provisions expire, CAP continues its lobbying campaign urging Congress for a permanent fix of the flawed sustainable growth rate (SGR) for physician payments under Medicare, as well as the technical component (TC) “grandfather” provision. Medicare physician payments are set to be cut by 27.4% on Jan. 1 unless Congress takes action.

But these Medicare provider payment “extenders” are just some of the high priority year-end provisions—such as the expiring payroll tax reduction and unemployment benefits—attracting broad public interest that Congress is grappling to address. Republicans are pushing for one legislative package that combines the SGR and the TC Grandfather provision with the payroll tax cut and unemployment insurance extension, among other reforms.

While the AMA, along with other health care providers groups including the College, continues to advocate to repeal SGR, a one- or two-year fix (at current rates) is a more likely scenario. Members of the House GOP Doctors Caucus are strongly pushing for a two-year fix. While a one-year fix is estimated to cost $22 billion, a two-year fix is estimated to tally $38 billion, making a longer patch the more fiscally sound option.

While there has reportedly been a push to vote on some of these measures separately, House Speaker John Boehner (R-OH) wants them to remain as a package, believing that it gives the legislation the best opportunity to win passage by 218 votes.

But time is running short for negotiations, as Rep. Boehner is pushing for this extender legislation to be passed in time for Congress to leave town by Dec. 16. House Majority Leader Eric Cantor (R-VA) has set a similar timeline, stating that the House would not adjourn until this legislation is resolved. He is hoping for a vote to be held the weekend of Dec. 17.

TC Advocacy

CAP member Robert Zirl, MD, FCAP, met with Rep. Kevin Brady (R-TX) of the House Ways and Means Committee, regarding extending the TC grandfather provision.To communicate the impact of the TC Grandfather provision on local providers, and shore up support for extending the provision, Texas CAP member Robert Zirl, MD, FCAP, met with members of the Texas delegation in Congress earlier this week in Washington, D.C. The TC Grandfather provision allows independent laboratories, under certain conditions, to bill Medicare for the technical component of surgical pathology services for hospital patients. By the CAP’s estimates, Texas has a large majority of TC Grandfathered hospitals.

At his Hill meetings, Dr. Zirl and the CAP staff continued to gather support for The Physician Pathology Services Continuity Act of 2011 (H.R. 2461), which would permanently extend the TC Grandfather. In addition, two co-sponsors were added to the bill this week: Rep Pedro R.Pierluisi (D-PR) and Rep David Loebsack (D-IA).

If this provision expires, Dr. Zirl said that his practice—Tejas Pathology in Tomball, Texas—will definitely feel an adverse impact. In his meetings with members of Congress and their staff, he told them that without the TC grandfather, the pathologists’ ability to provide patient care at the current level will certainly be compromised and patient access to certain tests could be in jeopardy.

Dr. Zirl met with the staff from the offices of Rep. Sam Johnson (R-TX) and Rep. Kevin Brady (R-TX), both of whom are on the House Ways and Means Committee. He also met with staff of both Sen. John Cornyn (R-TX) and Rep. Pete Session’s (R-TX) offices. Rep. Sessions is a member of the House Rules Committee, while Sen. Cornyn is a member of the Senate Finance Committee.

CAP Hosts PQRS Webinar for Pathologists

With the threat of pay cuts looming for all physicians, pathologists have been anxious to learn about the five pathology measures approved for reporting in the CMS’s 2012 Physician Quality Reporting System (PQRS) program. Over 800 pathologists registered for a webinar featuring experts from CAP and CMS, who shared insights into participating in the program and details on the pathology measures.

CMS Hosting Dec. Provider PQRS Call

CMS is holding a Dec. 20 National Provider Call with a question and answer session on 2011 Physician Quality Reporting System and Electronic Prescribing (eRx) Incentive Program from 1:30 – 3:00pm ET. More information is available on CMS’s PQRS Web site.

The 2012 Physician Fee Schedule included three new pathology measures—radical prostatectomy pathology reporting, immunohistochemical (IHC) evaluation of HER2 for breast cancer patients, and Barrett’s esophagus. Pathology-related measures continuing from the 2011 PQRS program are breast cancer resection reporting and colorectal cancer resection reporting.

The webinar entitled “Understanding CMS PQRS New Pathology Measures: How CAP Members Can Participate”, was hosted by the CAP Advocacy division, and featured two pathologists, and CAP leaders, Dr. Jonathan Myles, MD, FCAP, of Cleveland Clinic, and Emily Volk, MD, FCAP, of the Baptist Health System in San Antonio. Drs. Myles and Volk explained the pathology performance measures approved for the program, and supplied case studies. Nurse Consultant, Kimberly Schwartz, of the CMS Quality Measurement and Health Assessment Group in the Office of Clinical Standards and Quality, addressed general information about the PQRS program, including reporting through registries, who qualifies, and how physicians can participate.

All of the information in the experts’ presentations, including links to helpful information and other resources, is available on the CAP Advocacy website. A recording of the webinar will also be available soon.

Please note that at press time, a typo was reported on page 30 of the presentation PDF, misidentifying two of the colorectal cancer reporting codes. Colorectal cancer reporting codes are G8722 and G8724, along with G8721 and G8723. The corresponding slide has been corrected on the downloadable slide set.

Tavenner in “Good Position” for CMS Administrator Confirmation

The current nominee for CMS Administrator, Marilyn Tavenner, is in a good position to be confirmed by the Senate, given her balanced relationship with both Republican and Democratic members of Congress, a leading health care policy expert recently told Statline. As the agency’s Deputy Administrator, Tavenner was second to Donald Berwick, MD, who resigned as Administrator on Dec. 2.

“She has proven herself internally in the agency, but also externally among some key members of Congress,” said S. Lawrence Kocot, Deputy Director of Brookings Institution’s Engelberg Center for Health Care Reform. “During the confirmation hearings, the trick will be to separate her depth of professional experience from the Administration’s positions on some health care issues she has handled over the past two years that some members may take issue with.”

Early reaction from House Majority Leader Eric Cantor (R-VA) appears to indicate a positive reception from Congress. Rep. Cantor reportedly praised Tavenner’s nomination to the Washington Post, stating that he could “absolutely work with her.” Cantor worked with the nominee when he was a state legislator and she was CEO of the for-profit Richmond, Va.-based Hospital Corporation of America (HCA). Although as a House member, Rep. Cantor will not have a vote on her confirmation, his sentiments are indicative of broader bipartisan support among members of Congress, said Kocot.

Tavenner’s experience in the private sector as head of HCA for 25 years is also in her favor, especially heading into an election year, said Kocot. “With deep experience in the private sector, as well as the public sector as Virginia HHS Secretary under former Gov. Tim Kaine (D), she understands the needs of both agency and business leaders,” he explained. “There are many out there in the field who have confidence she can balance both the needs of the private and public sector, which is especially important in this political environment.”

Rep. Lance (R-NJ) Looks to Overhaul IVDx Approval in MODDERN Cures Act

New Jersey Congressman Leonard Lance (R) is looking to change regulatory approval and reimbursement determination of in vitro diagnostic tests, including companion diagnostics, through his recently introduced H.R. 3497, the “Modernizing Our Drug & Diagnostics Evaluation and Regulatory Network Cures Act of 2011”, also known as the MODDERN Cures Act. The bill also proposes certain periods of patent exclusivity when drug and diagnostic test makers collaborate on companion diagnostics.

Specific to diagnostic test development, this bill would establish the Advanced Diagnostics Education Council (ADEC) under the jurisdiction of the HHS. The ADEC would establish a “common lexicon” of standard terms and definitions of diagnostic testing and companion diagnostics.

Related to reimbursement for diagnostic tests, the bill proposes to change the process for determining fee schedule amounts by directing rate setting under gap-filling procedures and by creating an independent advisory panel. Furthermore, this panel will identify changes needed to improve the accuracy and appropriateness of rate-setting that takes into account openness, and predictability of the process.

The College is currently analyzing the impact that this proposed legislation could have on pathologists. Watch for continuing coverage in future issues of Statline.

JAMA Commentary Calls for More Research on Direct Patient Access to Test Results

Additional research and evidence for best practices is needed to guide the recent HHS Notice of Proposed Rulemaking (NPRM) that would release laboratory test results directly to patients upon request, according to a recent commentary in the Journal of the American Medical Association.

“While there is no doubt that patient engagement is important, we don’t quite know the precise impact of patients having direct access to test results without physician interpretation and before physicians have had the chance to see them,” lead author Hardeep Singh, MD, MPH of Baylor College of Medicine told Statline. “Test results often have different implications for different patients and it’s unclear how these variances would be individualized or communicated to patients. We really need to establish best practices, based on sound research, on issues such as how certain types of sensitive or abnormal results would be communicated to patients.” Dr. Singh’s co-author on the Nov. 28 article was Traber Giardina, a University of Houston PhD student.

In addition, research should focus on how providing direct access to test results impacts patient follow-up. “What we don’t know from the current state-of-the-science is if releasing test results to patients will improve follow-up outcomes and if patients will always know what to do next,” explained Dr. Singh, who is also the Chief of Health Policy and Quality at the Houston Veterans Affairs Health Services Research and Development Center of Excellence. “For example, we still hear about cases of missed abnormal mammogram despite direct patient notification of all mammograms for more than a decade.”

The CAP commented on the NPRM in mid-November, emphasizing that test results should not be released to the patient in advance of release to the ordering clinicians except in emergency circumstances. The College also recommended that HHS not mandate a specific time lag for the release of laboratory results to the patients once the laboratory has released the results to the ordering physician, so as to not undermine the relationship between the physician and patient.

OIG Advisory Opinion Scrutinizes Laboratory Mgmt Service Agreement

A recent advisory opinion from the HHS Office of Inspector General (OIG) weighed in against a proposed third party laboratory management service agreement, indicating that the arrangement could generate prohibited remuneration under the Federal anti-kickback statute. This opinion also highlighted the arrangement’s potential for overutilization and ordering of medically unnecessary testing services.

Under the proposed arrangement, the laboratory management company would provide in-office allergy testing and immunotherapy testing services under exclusive agreements with primary care physician (PCP) practices. In addition, the company would assist the PCPs in marketing the testing services not only through educational materials, but also by reviewing patient files to identify candidates for the services. The PCPs would provide office space, administrative staff, insurance, physician supervision, and interpretation of the laboratory results, and billing. The PCPs would bill for laboratory services, and then pay the management company 60% of their gross collections.

OIG Analysis

But according to OIG’s analysis, this arrangement would not be protected under current applicable anti-kickback safe harbors—such as those pertaining to space rental, as well as personal services and management contracts—because the services would be provided on an as-needed basis, rather than at specific intervals. Furthermore, the proposed arrangement did not meet certain compensation requirements—that it be set in advance and not take into account the volume or value of business generated between the parties.

In addition, the OIG found that the management services company’s proposed review of patient files to identify candidates for receipt of services to be “a suspect marketing activity” that could encourage the PCPs to order “medically unnecessary tests that could pose a risk of patient harm.” The “fee structure would create a risk of overutilization,” the advisory opinion stated.

This most recent OIG advisory opinion follows a similarly unfavorable opinion related to a third party laboratory business arrangement released by the agency in October, as detailed in Statline.

HHS Delays Stage 2 Meaningful Use Compliance for Early Adopters

Earlier this week HHS Secretary Kathleen Sebelius announced that hospitals and eligible providers who attested to Stage 1 of the agency’s “Meaningful Use” EHR incentive program in 2011 would not have to meet Stage 2 criteria until 2014, rather than 2013. The delay is to allow faster and easier adoption of health information (IT) criteria outlined in Stage 2.

This delay was first proposed in March by the Office of the National Coordinator for Health Information Technology’s HIT Policy Committee’s workgroup on Meaningful Use.

CAP’s Advocacy efforts related to Meaningful Use can be found on the “Comments to Regulatory Agencies” Web site under “Health Information Technology.” For more information on the CMS Meaningful Use EHR Incentive Program, visit the agency’s Web site.

CAP Concerns

The CAP continues to be concerned about numerous aspects of the Meaningful Use program, as outlined in Stage 2 criteria comments submitted over the summer. Specifically, because the rule is targeted toward office-based physicians—especially primary care providers—pathologists will face penalties for mandates that they cannot comply with for a number of reasons, including their scope-of-practice, typical interactions with patients (not usually face-to-face), and their use of laboratory information systems instead of certified EHRs.

The College is addressing some of these concerns through the Office of the National Coordinator’s (ONC) HIT Policy Committee’s Meaningful Use Workgroup Specialty Subgroup. At a recent hearing, the Subgroup appeared to be inclined to recommend that ONC and/or CMS deal with specialists’ challenges, such as certain certification issues, either through exemptions or other means. Looking ahead, the group also indicated that for proposed Stage 3 criteria, it may recommend a requirement that test results are sent back to the referring physician. This specialist subgroup is planning on moving these and other recommendations to the larger Meaningful Use Workgroup for consideration. All positive developments to be sure, although the ONC and CMS have ultimate authority for the program.

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.


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