College of American Pathologists
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February 2, 2012  •  Volume 28, Number 3
Next Issue: February 16, 2012
© 2012 College of American Pathologists

2012 CAP Policy MeetingIn This Issue:

Registration Is Now Open for 2012 CAP Policy Meeting

Engage, Learn, Advocate. Network. Registration is now open for the 2012 CAP Policy Meeting in Washington, DC, May 7 – 9, 2012. The 3-day meeting is a must-attend for CAP members who want to be part of the CAP’s advocacy effort. It is a rare chance to hear from and engage with nationally recognized health policy experts, key decision makers, and CAP’s own leadership and advocacy team on today’s top issues impacting pathologists. Find out what opportunities and threats policies on ACOs, HIT, and personalized medicine pose to pathologists, earn CME, and take this opportunity to meet with your member of Congress as part of the CAP Hill Day. Meeting registration is free and includes all meeting materials, CME, breakfasts, lunches, and cocktail receptions during the meeting. Attendees will be responsible for their travel, hotel and other expenses. Seating is limited. Visit the 2012 CAP Policy Meeting page for more information and registration.

PTO Seeks Public Input on Genetic Diagnostic Testing

The United States Patent and Trademark Office (PTO) last week invited public comment on the issue of independent second opinion genetic diagnostic testing, and published specific questions it hopes to answer through comments and public hearings in February and March this year.

The PTO announcement which appeared in the Federal Register on January 25, 2012, said the public input will be used to prepare a report to Congress by June 15, 2012, as mandated in the America Invents Act, regarding independent second opinion genetic testing where patents and exclusive licenses exist that cover primary genetic diagnostic tests.

Among the questions the public is asked to address are:

  1. The impact that the current lack of independent second opinion testing has had on the ability to provide the highest level of medical care to patients and recipients of genetic diagnostic testing, and on inhibiting innovation to existing testing and diagnoses;
  2. The effect that providing independent second opinion genetic diagnostic testing would have on the existing patent and license holders of an exclusive genetic test;
  3. The impact that current exclusive licensing and patents on genetic testing activity has on the practice of medicine, including but not limited to: the interpretation of testing results and performance of testing procedures; and
  4. The role that cost and insurance coverage have on access to and provision of genetic diagnostic tests.

The College is a plaintiff in the gene patent case against Myriad Genetics, and has been an active opponent of gene patents, particularly when such awards block patients’ access to critical care and medical second opinions. The CAP will submit written comments before the March 26 deadline.

The CAP believes gene patent restrictions on genetic testing infringe on the practice of medicine, particularly for pathologists. “Pathologists are obligated to evaluate, understand, and interpret the biological processes responsible for disease including their genetic underpinnings,” said Jan Nowak, MD, PhD, FCAP, a member of the CAP Personalized Healthcare Committee, and Director of the Molecular Diagnostics Laboratory at North Shore University Health System in Evanston, IL. “Restriction of that professional responsibility is, at best, bad medicine, and at worst, not medicine at all.”

“Independent, second opinion diagnostic testing would assure the quality of test results and improve testing in terms of biological understanding and technical modification,” Dr. Nowak said. “It will expand the usage of existing tests to other clinical conditions where they may be useful, and stimulate increased research and innovation to remain competitive and improve quality and reduce costs.”

The first of two public hearings will be held Thursday, February 16, 2012, 9 am to 5 pm, in Alexandria, VA. The second hearing will be held on Friday, March 9, 2012, 9 am to 5 pm, in San Diego, CA. See the Federal Register announcement for more details as well as testimony and written comment submission deadlines. Contact Saurabh Vishnubhakat, Attorney Advisor, Office of Chief Economist, (571) 272-9300.

Congress Returns to Work on SGR, Other Key Issues

Late last year, Congress passed the Temporary Payroll Tax Cut Continuation Act of 2011, which extends 2011 Medicare physician pay rates and the Technical Component (TC) “Grandfather” provision through February 2012. After passing the temporary legislation, Congress formed a conference committee, charged with fashioning a bill to be considered by the full House and Senate, hopefully before the February 29th deadline.

There are just four weeks until the Temporary Payroll Tax Cut Continuation Act of 2011 is set to expire, and unless Congress passes legislation to replace it, physicians will see their Medicare payments cut by nearly 28% effective March 1, and 160 million workers will face smaller paychecks and another 20 million will lose their unemployment benefits.

Members of Congress from both parties say they want to extend the payroll tax cut and long-term unemployment benefits, and will identify ways to pay for them. Physician payment provisions like fixing the Medicare Sustainable Growth Rate (SGR) formula and extending the technical component (TC) “grandfather” provision are also part of these deliberations.

Congress has passed a series of short term fixes to the SGR in the past few years, in effect compounding the debt as it accrues each year. It is now costly enough that replacing the SGR will take significant political will as well as capital. It doesn’t help matters that the Congressional Budget Office this week revised its estimate for replacing the SGR, from $290 billion in November 2011, to $316 billion in 2012. The American Medical Association, the CAP, and other physician groups continue to urge Congress to bite the bullet and replace it now while there are unspent savings from other programs, such as the Oversees Contingency Operations (OCO) fund to offset it. The OCO fund refers to the nearly $900 billion in discretionary funds previously allocated for the wars in Afghanistan and Iraq, which could be used to offset retiring the SGR debt. A permanent fix would be unlikely without a budget offset to pay for it.

Many in Washington see this as the last major piece of legislation to be considered by Congress before the November elections, making lawmakers wary of decisions that could cost them the election. Despite assurances from Congressional leaders that they will pass a doc fix before the current extension expires, details of a possible fix have not yet been made public.

The TC “grandfather”, which costs $80 million per year to support patient care in rural and underserved areas, is in danger of being eliminated because it is one of many provisions bundled into what is known as the Medicare “extenders”, which House Republicans have scrutinized for maximum savings.

The House bill passed in December 2011 did not extend this program, which would have expired on December 31, 2011. This is the first time the House hasn’t recommended extending the program, raising the alarm that Congress might end the independent labs’ ability to bill Medicare for the technical component.

As a result, CAP grassroots have continued meeting with their Members of Congress to advocate their support.

Rep. Tom Price, MD (R-GA) at a meeting with CAP Governor Patrick Godbey, MD, FCAP.Last week, CAP Governor Patrick Godbey, MD, FCAP, of Southeastern Pathology Associates in Brunswick, Georgia, met with a half-dozen members from the Georgia House and Senate delegations, including Rep. Tom Price, MD (R-GA), a conferee on the congressional conference committee appointed to draft the Medicare legislation.

“The conference committee is looking for a fiscally responsible way to pay for the programs and the extenders,” Godbey said. “Lawmakers were receptive to learning more about the issue.”

Godbey works with 19 rural hospitals in Georgia and northern Florida. His message to lawmakers: “This is a relatively small program but it is crucial for small and rural hospitals. Many of these small and rural hospitals depend on the ability of independent labs to bill the technical component. Eliminating this program will present a burden that some hospitals won’t be able to bear, and if allowed to expire, we’re going to see many of those hospitals stop providing these services.”

Congress has until February 29 to reach agreement and pass a bill that will fund the entitlement programs, set Medicare physician pay, and decide the fate of the Medicare extenders, including the TC Grandfather.

Statline will continue to closely monitor this legislation and the actions of the conference committee.

PCORI Releases Draft Priorities For Comparative Effectiveness Research

The newly launched Patient-Centered Outcomes Research Institute (PCORI), created to help determine the most effective medical treatments, released its draft National Priorities for Research and Research Agenda, last week.

The document, which is open for public comment through March 15, identifies five areas where comparative effectiveness research is needed to support decision-making:

  • Assessment of Options for Prevention, Diagnosis, and Treatment
  • Improving Health Care Systems;
  • Communication and Dissemination Research;
  • Addressing Disparities; and
  • Accelerating Patient-Centered Outcomes Research and Methodological Research.

These areas encompass the patient-centered research that the independent PCORI institute intends to fund, and are inclusive of all diseases and health conditions. PCORI’s draft Research Agenda outlines more specific areas of research for each of the five priorities.

The work PCORI will fund has the potential to impact health care delivery for generations. Some of PCORI’s research priorities align closely with the central, transformational role the CAP envisions pathologists will pursue over the next decade, namely improving patient diagnosis and treatment through outcomes data analysis.

“This type of research and the development of clinical decision support tools will come from a partnership between pathologists as medical test information experts, and the health system informatics team,” said Dr. Emily Volk, MD, FCAP, Chair of the CAP Working Group on Measures & Performance Assessment. “If this program is to be successful, it must support this type of research by community pathologists as well as research pathologists in academic settings.”

Under guidelines outlined the 2010 Patient Protection and Affordable Care Act (PPACA), PCORI’s governing board comprises a broad cross-section of health-care stakeholders, including representatives of drug and device makers, insurers, consumers, researchers and government agencies that will control an estimated $3 billion over the next decade to help fund and oversee comparative effectiveness research.

Part of its funding will come from a new $1 to $2 per-person annual fee on Medicare and most health insurance policies, and the law prohibits its findings from being “construed as mandates for practice guidelines, coverage recommendations, payment, or policy recommendations.”

During the public comment period, PCORI hold will a series of focus groups and sponsor a national forum on Feb. 27 in Washington, DC.

Based on the comments it receives, PCORI will update its research priorities and issue a revised statement of its priorities in April. After that it will invite researchers to propose specific studies with the goal of committing up to $120 million in funding this year.

AMA Lobbies to Delay ICD-10 Implementation

The American Medical Association sent a letter to Speaker of the House John Boehner earlier this month, asking Congress to halt implementation of the ICD-10 coding system.

The changeover to ICD-10 will increase the current billing codes by five-fold from 13,000 in ICD-9, to over 68,000 in ICD-10. According to Madara, it could cost a single medical practice anywhere from $83,290 to more than $2.7 million to make the change.

The AMA’s letter argues that implementing ICD-10 will be costly and burdensome for physician practices, and transition to ICD-10 could temporarily threaten their cash flow at a time when physicians must invest in health IT, and Medicare rates are falling. Plus, physicians face added pressure from potential penalties for non-compliance with the e-prescribing, Meaningful Use, and PRQS programs.

“The timing of the ICD transition that is scheduled for October 1, 2013, could not be worse,” wrote AMA Executive Vice President James L. Madara, MD. The letter includes a table and timeline to illustrate the volume of financial penalties associated with various federal programs that physicians will be facing if they do not successfully participate in these programs.


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