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ePolicy News April, 2012

Wednesday, April 4, 2012



ASCP Initiative to Address Workforce Garners Media Attention

ASCP’s Commitment to Action in the Clinton Global Initiative (CGI) to create more job opportunities in the medical laboratory has caught the attention of media. An overview of ASCP’s initiative to expand educational access to laboratory science programs in New York was recently reported by WNYT-TV in Albany, N.Y. The plan will develop classrooms and distance learning curricula, a coordinated network of clinical rotation sites, an accelerated technician to technologist program, and an electronic instrumentation simulation laboratory.

ASCP’s five-year commitment to CGI includes a long-term goal of using New York as a model to be implemented in states across the country.

Other coverage has included the Boston Globe, San Francisco Chronicle, and Yahoo News. To view the WNYT-TV broadcast, visit

Money Matters: ASCP 2012 Wage and Vacancy Surveys Update

The American Society for Clinical Pathology’s (ASCP) biennial Wage and Vacancy Surveys have arrived. These surveys, which have been conducted for the past 22 years, have become the primary source of information for academic, governmental, and industry experts in defining the state of the nation’s laboratory workforce.

The surveys include partnerships with:

  • AABB
  • American Association of Pathologists’ Assistants (AAPA)
  • American Society for Clinical Laboratory Science (ASCLS)
  • American Association for Clinical Chemistry (AACC)
  • American Medical Technologists (AMT)
  • American Society of Cytopathology (ASC)
  • American Society for Cytotechnology (ASCT)
  • American Society for Microbiology (ASM)
  • Clinical Laboratory Management Association (CLMA)
  • ARUP
  • LabCorp
  • Quest

New questions were added to the Wage survey such as determining the difference in wages between licensed and non licensed states and overall length of time a laboratory professional has worked in the clinical laboratory profession. Traveling professionals and subcontractors/contract laboratory professionals will also be surveyed this year to examine their salaries compared to permanent, part-time, per diem, and on call laboratory professionals.

The Wage survey was launched on March 22, 2012, and will remain open until April 30, 2012.

The target launch for the Vacancy Survey is mid-April 2012 and it will remain open until May 31, 2012. Some of the questions added in the vacancy survey address the effect of vacancies on new testing technologies and what happens to an unfilled position, whether or not it is eliminated or left open until filled.

The publication date for both the Wage and Vacancy survey reports will appear in an upcoming issue of ASCP’s LabMedicine. Please visit the ASCP website for the link to the survey.



Congress Reconsiders Workforce Investment Act

Last month, as the House Committee on Education and the Workforce began to look at reauthorizing the Workforce Investment Act (WIA), Congressmen John Tierney (D-Mass.), Rubén Hinojosa (D-Texas), and George Miller (D-Calif.) introduced sweeping legislation (H.R. 4227, or WIA of 2012) to expand opportunities for workers, help businesses staff high-skilled and open positions, and assure that tax-payer dollars are being spent wisely and efficiently. WIA is the preeminent federal employment service and job training law.

According to the Bureau of Labor Statistics, there are 3.5 million open positions nationwide, many that cannot be filled due to a lack of qualified candidates. This is certainly the scenario in laboratory medicine, with a growing need for laboratory professionals, yet laboratory training programs are unable to train a sufficient number of qualified personnel to fill the gap. ASCP has long championed WIA as a mechanism to fill that void.

In an effort to solve this job crisis, the WIA of 2012 is designed to strengthen the existing system by streamlining and increasing access to training, promoting innovation, and ensuring accountability and transparency.

This bill authorizes increased investments in technology and digital literacy, and enhances online training and other technological improvements that allow rural residents to receive training in high-growth, high-demand occupations.

“Workforce development programs are an important part of the nation’s economic recovery and job creation efforts,” said Rep. Miller, the senior Democrat on the Education and the Workforce Committee. “The bill introduced today creates a modern workforce investment system. While the economy is turning around, there is much more work to be done to help the millions of Americans without jobs, especially for the long-term unemployed.

The WIA was enacted in 1998 to establish a framework for delivering federally funded employment and training services in this country. The law created local workforce investment boards comprised of business representatives, labor organizations, educational institutions, economic development agencies, and community-based organizations.

A summary of the WIA of 2012 can be found here and here.

Brain Injury Legislation Generates Congressional Hearing

On March 19, the House Energy and Commerce Subcommittee on Health held a hearing pertaining to traumatic brain injury (TBI). The hearing, “A Review of Efforts to Prevent and Treat Traumatic Brain Injury,” examined the effect of federal, state, and private efforts to prevent and effectively treat TBI and resulting disabilities.

TBI occurs when an external force injures the brain. According to data collected by the Centers for Disease Control and Prevention, approximately 1.7 million people, both children and adults, sustain a traumatic brain injury annually. Of these, 52,000 die, 275,000 are hospitalized, and 1.3 million are treated and released from an emergency room.

ASCP began to follow the issue of brain injuries after lending its support to H.R. 2600, National Pediatric Acquired Brain Injury Plan Act of 2011, at the request of the Sarah Jane Brain Foundation, which is working to reduce the effect of abusive head trauma on children and families.


Capitol Hill Prospective: Lobbying Lawmakers
A Resident’s View

Hurrying up the marble steps of the Russell Senate building, I felt a twinge of excitement and apprehension. It had been eight years since I last visited Capitol Hill to advocate for issues that I cared about. Through the Resident Council Hill Day Grant, ASCP gave me a chance to reconnect with my pre-medicine roots in public policy and advocacy.

I should have been more nervous in my meetings with Congressional aides, but I had been well prepared the day before by Jeff Jacobs, ASCP Vice President for Public Policy and Advocacy, and his equally knowledgeable staff and armed with fact sheets on the legislative priorities for the day.

Also reassuring was to be greeted by friendly staff in the Senators’ and Congressmen’s offices as well as familiar symbols of my adopted home, the Commonwealth of Massachusetts, including an old Boston Globe newspaper dispenser in a Senator’s office and a pair of New Balance sneakers perched on the shelves of both a Senator and a Congressman’s office.

I discovered a local connection with one staffer, whose spouse was raised in a city near where I grew up in Southern California.

Another staffer revealed a positive personal experience with pathologists, who were involved in his young child’s health care.

One of many highlights of the weekend was the chance to promote pathology with lawmakers; I think it’s important that voices for our subspecialty connect to the larger public, to remind and educate about the impact we have in health care.

That’s why another highlight of Hill Day weekend was meeting passionate and engaged members of ASCP, particularly those serving on the Commission on Public Policy. It was inspiring as a pathologist-in-training to witness the collaboration and discourse among all the stakeholders in pathology, including pathologists, technicians, and medical laboratory scientists.

Hill Day was a fantastic experience. With health care at the top of the public discourse these days, I hope more residents get a chance like I did to participate and be a voice for our profession.

Tobi Quinto, MD, MPH, Tufts Medical Center
(The Views Expressed in this Editorial are those of Dr. Quinto and do not reflect any organization or entity.)

Melissa C. Austin, MD of University of Washington, Seattle, WA was the other "Hill Day" grant recipient.



New IOM Report Examines Clinical Use of Genome-Based Diagnostics

The Institute of Medicine (IOM) has released a report examining issues that are preventing the development of evidence and innovative approaches for establishing evidence necessary to enable the adoption of genomic diagnostic tests in clinical care. The lack of data showing that use of these tests leads to improved outcomes has stifled their translation to clinical practice. The report, Genome-Based Diagnostics: Clarifying Pathways to Clinical Use–Workshop Report, summarizes the discussions at two recently convened meetings organized by the IOM’s Roundtable on Translating Genomic-Based Research for Health. The purpose of the workshops was to examine how evidence is viewed by different stakeholders, as well as current approaches for generating evidence. Participants considered evidence required for clinical use, regulatory oversight, guideline inclusion, and coverage and reimbursement of genomic diagnostic tests. The goal of the workshop was to clarify pathways for using such tests in clinical practice.


ASCP Protests Palmetto’s MolDx LCD

On March 27, ASCP wrote the Centers for Medicare and Medicaid Services (CMS) urging the agency to instruct Palmetto GBA to cancel its recent Local Coverage Determination (LCD) for Molecular Diagnostic Tests (MolDX). Though ASCP urged the cancellation of the Palmetto LCD, the Society expressed its appreciation for Palmetto’s attempt to address the complicated billing environment for molecular assays. Payers often do not know what the laboratory is testing for or whether the testing is appropriate and require laboratories to provide additional information before payment will be provided.

However, CMS is reviewing and may soon approve, a new Current Procedural Terminology (CPT) coding taxonomy of approximately 100 new molecular codes, developed by the American Medical Association with input from CMS. ASCP is concerned that the Palmetto LCD could unnecessarily delay nationwide adoption of a coding set that could reduce the complication for laboratories to receive payment for the molecular services they perform. The new program also adds an unnecessary burden on clinical laboratories affected by the Palmetto LCD as that they would have to learn a new coding requirement that would likely be replaced in the near future with another (national) coding taxonomy. ASCP is also upset that the Palmetto LCD did not accept stakeholder input on the development of many aspects of the LCD. ASCP noted in its letter that a well thought out coding structure needs the perspectives of all key stakeholders.


ASCP Secures Changes to CMS Medicare Place of Service Transmittal

On March 30, CMS issued a new Place of Service Transmittal in response to a request from the ASCP. The new document, Transmittal 2435, replaces Transmittal 2407. Though overall we expressed support for Transmittal 2407, ASCP raised several concerns about its unintended impact on the laboratory industry. ASCP urged in its letter that implementation of Transmittal 2407 be delayed from April 1 to at least July 1 to ensure that laboratories have sufficient time to deal with the operational and data systems changes need to ensure compliance. This would also eliminate potential complications that could arise for independent laboratories performing the technical component (TC) anatomic pathology services for patients at grandfathered hospital. The TC grandfathering provisions are set to sunset on July 1. In response to the ASCP request, CMS specified an implementation date on October 1 for the new transmittal.

ASCP also requested a change in Transmittal 2407’s language regarding the place of service for pathology or other services. The change is necessary to ensure that pathologists and laboratories not meeting the definition of an independent laboratory would be able to bill for their services without complication. Additionally, ASCP informed CMS that Transmittal 2407 overlooked how laboratories would bill for archived services, which could conceivably result in nonpayment. ASCP urged that place of service -11 (office) be designated to ensure payment.

Transmittal 2435 does not address these latter concerns; however, CMS indicated in this new transmittal that there are other issues, such as the issues affecting pathology and laboratory medicine that still must be addressed. As a result, ASCP anticipates that Transmittal 2435 will be revised later in 2012.


Grassroots Initiative Targets White House for Increased NIH Funding

The last White House petition to increase the National Institutes of Health (NIH) funding failed by fewer than 500 votes to reach the necessary 25,000 vote threshold. A new petition has been started with a deadline of April 17. If you agree with an increase in NIH funding, please go the website and sign the petition now. Go to




Supreme Court Sends Myriad Gene Patent Ruling Back to Lower Court

The U.S. Supreme Court has set aside last year’s ruling by the U.S. Court of Appeals for the Federal Circuit that granted Myriad Genetics, Inc. patents on the BRAC1 and BRAC2 genes linked to breast and ovarian cancers, and ordered further review by the lower court in light of a conflicting ruling in a similar case. In that case, Mayo Collaborative Services v. Prometheous Laboratories, Inc., the Supreme Court unanimously ruled that companies cannot patent observations about a natural phenomenon.

With the Myriad judgment vacated, the case now returns to the same three-judge panel that issued the decision for reconsideration as to how the case may or may not relate to the Prometheous decision. The Federal Circuit could issue a decision with the same or a different outcome, or the case could be reviewed by the full-judge panel. Once a new judgment is issued, either side would again have the opportunity to petition for a Supreme Court review. The move is expected to delay an ultimate verdict in the Myriad case by as much as several years.

ASCP is among the plaintiffs in the landmark lawsuit challenging patents held by Myriad Genetics and the University of Utah Research Foundation on the BRAC1 and BRAC2 breast cancer genes.



Colorado State Pathology Society Victorious in Direct Billing Legislation

The Colorado Society of Clinical Pathologists (CSCP) as well as the College of American Pathologists (CAP) has been successful in advocacy efforts on behalf of direct billing legislation in the state. Gov. John Hickenlooper (D) is expected to sign into law legislation ensuring that patients are billed for anatomic pathology (AP) services only by the physician performing or supervising the service to protect the patient from unnecessary mark-ups by ordering physicians.

CAP and CSCP worked collaboratively to pass H.B. 1221, which unanimously passed the state’s House of Representatives by a vote of 62-0, as well as the Senate by a vote of 34-0.

Once Gov. Hickenlooper signs the bill into law, Colorado will be the 19th state to pass a direct billing law for AP services. Currently, more than two-thirds of the U.S. population is billed directly for anatomic pathology services under federal and state law. See also:



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