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ePolicy News May 2013

Wednesday, May 1, 2013



Supreme Court Considers Validity of Gene Patents

The United States Supreme Court heard arguments last month in Association for Molecular Biology v. Myriad Genetics, Inc., et al, the landmark lawsuit challenging whether isolated human genes are patentable. The case questions Myriad Genetics’ right to patent BRCA1 and BRCA2, two genes that correlate to increased rates of breast and ovarian cancer. The patents allow Myriad to be the exclusive U.S. commercial provider of screening assays for these genes and permit the company to determine the terms and price for testing, making it impossible for women to access alternative tests or obtain a second opinion about their results. Last fiscal year, Myriad made $405.5 million from BRCA testing, accounting for more than 80 percent of its revenue. The patents also give Myriad the authority to prohibit researchers from investigating these genes without first gaining permission.

During the hearing, the justices posed questions that may indicate some skepticism as to whether an individual or company should be granted a patent on a human gene. Numerous analogies were offered by both the attorneys and the justices in attempts to clarify the central issue: Is a human gene that has been isolated and extracted from the body a product of nature and, therefore, ineligible for patenting? Or, is the isolated gene a new and different material?

A Supreme Court ruling would bring to an end the ongoing legal battle regarding the legality of gene patents that commenced in 2009 when the American Civil Liberties Union (ACLU), representing numerous clients, including medical societies, researchers, patient advocates, and patients, sued Myriad Genetics and the United States Patent and Trademark Office (USPTO). The plaintiffs in the case, which include ASCP, argue that patents on human genes, which are “products of nature,” violate the First Amendment and patent law. Furthermore, such patents interfere with medical treatment and stifle scientific research. The U.S. Patent and Trademark Office has granted patents on at least 4,000 human genes to companies, universities, and researchers that discovered and sequenced them.

The plaintiffs in the case petitioned the Supreme Court after a divided federal appeals court reaffirmed its ruling last year upholding Myriad Genetics’ right to patent BRCA1 and BRCA2. It is important to note, however, that the Court has limited its grant of the appeal to the patentability of human genes. The Court did not address issues surrounding method claims or standing to sue.

A decision in the case is expected by the end of June.



ASCP Applauds President’s Proposal to Reform the Stark Self-Referral Law

ASCP joined with other members of the Alliance for Integrity in Medicare (AIM) in applauding President Obama’s proposal to reform the Stark Self-Referral Law’s In-Office Ancillary Services (IOAS) Exception. AIM is a broad coalition of medical specialty, laboratory, radiation oncology, and medical imaging groups committed to ending the practice of inappropriate physician self-referral, such as those involving physician in-office anatomic laboratory arrangements.

On April 9, President Obama energized efforts to reform the Stark Law when he proposed excluding radiation therapy, advanced imaging, and physical therapy services from the IOAS Exception. In a statement, AIM members said, “AIM has long supported restrictions on physician self-referral, and we would strongly recommend adding anatomical pathology services to the proposed list of excluded services, as the same overutilization and patient care concerns exist.”

ASCP and other members of AIM have argued that the IOAS loophole “results in increased spending, unnecessary utilization of medical services, and potentially compromised patient choice and care, thusly eroding the integrity of the Medicare program.” Most important, the Obama proposal puts a price on the cost of inappropriate self-referral arrangements. The AIM statement noted that “the Office of Management and Budget estimates that closing the loophole for these services would provide a savings of $6.1 billion over the standard 10-year budget window. Even more savings could be achieved by adding anatomic pathology services to this list.”

“Reforming this policy will ensure that Medicare patients receive the highest quality and safest health care most appropriate to their needs and that Medicare policy incentives are properly aligned—a positive for beneficiaries, providers, and all other Americans.”

ASCP Urges CMS to Restore Cuts to 88305, Surgical Pathology Codes

On April 25, ASCP wrote the Centers for Medicare and Medicaid Services (CMS) urging the agency to restore cuts it made in the technical component payment for 88305 and other surgical pathology CPT codes. ASCP’s letter questions the agency’s rejection of some of the practice expense inputs that resulted in a sharp decrease in reimbursement for the technical component of CPT code 88305 and other surgical pathology codes.

These changes are due, in part, to CMS’s refusal to accept a number of direct practice expense inputs that were approved and recommended by the Resource-based Relative Value Scale Utilization Committee (RUC). CMS’s “refinements” to the RUC recommendations resulted in staggering cuts to most of these codes. With the exception of CPT codes 88307 and 88309, most of these codes experienced more than a 50-percent reduction in reimbursement of the technical component. As seen in the chart below, the technical component (TC) of 88305 (Level IV–Surgical pathology and gross and microscopic examination) was reduced from $69.78 to $33.70, a 52-percent cut in reimbursement.

Surgical Pathology TC Reimbursement

CPT Code

















$69.78 $33.70










ASCP argued that rejection of these costs was done erroneously and noted that many items recommended by the RUC are outlined as commonly acceptable direct practice expense inputs in CMS’s Direct Input List. For example, CMS rejected courier transportation costs as a direct practice expense input; however, the agency’s own documentation allows for recognizing transportation costs, such as Federal Express and device shipping costs, as direct inputs.

ASCP wrote that “we believe that the CMS Direct Inputs Code List offers important insight into the issue of direct inputs, as it speaks to the fact that these costs are not only legitimate costs that should be allowed, but that there is precedent for recognizing these cost inputs as direct inputs, not indirect inputs.” ASCP concluded its letter by urging CMS to “accept all of RUC-recommended direct inputs for the 88300-88309 coding family.”



Tennessee Governor Signs Exemption from State Laboratory Personnel Law

ASCP recently urged Tennessee Gov. Bill Halsam to veto legislation approved by the state legislature that would broaden an exemption from the state laboratory personnel licensure requirement. ASCP had urged a veto of the flawed legislation, citing its conflicts with federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) requirements and that the legislation creates an uneven playing field for hospital and reference laboratories. Ultimately, however, this misunderstood legislation was signed into law.

The legislation, SB1269, would broaden an exemption to the state laboratory personnel licensure law for laboratories that perform “advanced” biochemical, forensic, or toxicological testing. Several of the sponsoring organizations seeking the legislation sought to broaden the old exemption provided for forensic and compliance drug testing laboratories so that they could expand into the patient testing market. One of the entities reportedly involved with the bill, an oncology group practice, was seeking the exemption so that its Laboratory Developed Test would not have to use licensed laboratory personnel.

ASCP noted in its letter to the Governor that the measure would seemly allow exempt clinical laboratories to use laboratory personnel that did not satisfy the CLIA standards for high complexity testing. Opponents of the measure noted that the exemption was intended to benefit laboratories performing high complexity testing. ASCP noted that the personnel standards mandated by the bill would not require testing personnel to complete a baccalaureate degree with a major in a CLIA-recognized science, only a bachelor’s degree and 16 semester hours of academic science. As a result, the bill’s personnel standards fall below the CLIA high complexity testing requirements.

But because of the way the measure was crafted, it is unclear that these laboratories could be held to the CLIA requirement. Several of the accrediting agencies that the state recognized are not recognized by CLIA as recognized accrediting bodies. It was unclear whether the Tennessee Department of Health or the Tennessee Medical Laboratory Board have the authority to require exempt laboratories to satisfy the appropriate CLIA requirements.

ASCP also raised a concern that the legislation “[creates] an uneven playing field for clinical laboratory services in Tennessee by allowing exempt laboratories to meet a lower regulatory threshold than testing services provided by reference laboratories, such as Quest Diagnostics and LabCorp, as well as Tennessee’s hospital and independent laboratories.”



Humanitarian Projects Hailed for Cultural Sensitivity

ASCP participated in the inaugural conference of the Center for Cuturally Responsive Evaluation and Assessment (CREA) in Chicago last month. Hosted by the University of Illinois College of Education, the conference brought together scholars, administrators, researchers, and policymakers from around the globe to discuss how they incorporate cultural awareness in assessments and evaluations of their humanitarian projects. CREA’s mission is to encourage organizations and individuals to exercise cultural sensitivity in projects undertaken in the United States and around the globe.

ASCP submitted an abstract on how it assesses needs for pathology laboratories that provide testing for HIV/AIDS in sub-Saharan Africa. Asma Ali, MA, ASCP Manager of Measurement and Evaluation, and Edna Garcia, MPH, ASCP Manager of Scientific Engagement and Research, presented on the implications of a “Scope of Practice” needs assessment survey used to determine the current state of practice for HIV/AIDS and malaria laboratories in sub-Saharan Africa. The research examines the cultural factors and values that will influence the survey development and deployment process. Attendees expressed considerable interest in the topic because cultural responsiveness in a laboratory medicine survey is a unique approach to the conference topic. As a scientific organization, ASCP is dedicated to promoting health by incorporating “culturally responsive” and “culturally relevant” practices in its assessments and evaluations.

For more information on the conference, click: 


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