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ePolicy News August, 2011

Monday, August 1, 2011



Federal Appeals Court Upholds Patenting of Genes in Myriad Lawsuit

In a split decision, the U.S. Federal Circuit Court of Appeals ruled late last month to partially reverse a lower court ruling challenging patents on two human genes associated with hereditary breast cancer and ovarian cancer. The ruling upholds the right of Myriad Genetics, to patent two “isolated” human genes, BRCA1 and BRCA2, thus granting the company the exclusive right to perform diagnostic tests on the genes and preventing other researchers from even looking at the genes without first getting permission from Myriad. The decision permits the continuation of Myriad's monopoly on the BRCA genes, making it impossible for women to access alternate tests or get a comprehensive second opinion about their results. It also allows Myriad to continue charging a high price for its tests.   

“ASCP is disappointed in the court’s ruling, the patenting of human genes harms patients and places a stronghold on research, but we remain hopeful the case will continue to make its way through the court system so that our nation’s patients will prevail,” said ASCP President John Tomaszewski, MD, FASCP, and Professor and Interim Chair of the Department of Pathology and Laboratory Medicine at the University of Pennsylvania, Philadelphia.

“Today’s ruling is a blow to the idea that patent law cannot impede the free flow of ideas in scientific research,” said Chris Hansen, a staff attorney with the ACLU Speech, Privacy and Technology Project. “Human DNA is not a manufactured invention, but a natural entity like air or water. To claim ownership of genetic information is to unnecessarily block the free exchange of ideas.”

After obtaining the patents in 1998, Myriad issued “cease and desist” warnings to researchers at the University of Pennsylvania and others who were conducting BRCA research. Those researchers, along with patient advocacy groups and several scientific societies, including ASCP, filed suit in 2009 to invalidate the patents. The lawsuit charged that the BRCA patents are illegal and restrict both scientific research and patients’ access to medical care, and that patents on human genes violate both the First Amendment and patent law because genes are “products of nature.” The impact of the lawsuit’s ultimate outcome could reach far beyond the patents on the BRCA genes as it challenges the whole notion of gene patenting. Approximately 20 percent of all human genes are patented, including genes associated with Alzheimer's disease, muscular dystrophy, colon cancer, asthma, and many other illnesses.

While products of nature are not patentable, the Federal Circuit, a specialized court that hears patent appeals, ruled by a 2-to-1 vote that “isolated” DNA is patent-eligible because, as Judge Alan Lourie wrote, “the claims cover molecules that are markedly different—have a distinctive chemical identity and nature—from molecules that exist in nature.”

Judge Kimberly A. Moore agreed that genes were patentable, but for different reasons, including that only Congress should change Patent Office policy regarding the patent eligibility. Judge Moore wrote, “Judicial restraint is particularly important here because an entire industry developed in the decades since the Patent Office first granted patents to isolated DNA. Disturbing the biotechnology industry’s settled expectations now risks impeding, not promoting, innovation.”

However, one of the judges on the panel disagreed in part with the decision, writing that patents on the genes should be invalid. “Extracting a gene is akin to snapping a leaf from a tree,” wrote Judge William C. Bryson. “Like a gene, a leaf has a natural starting and stopping point. It buds during spring from the same place that it breaks off and falls during autumn. Yet prematurely plucking the leaf would not turn it into a human-made invention.”

The ruling rejects the arguments made earlier this year by the U.S. Department of Justice (DOJ), which had filed a brief arguing that isolated DNA should not be patented. The DOJ position is a dramatic departure from the long-standing policy of the U.S. Patent and Trademark Office to grant such patents.

The highly controversial and precedent-setting case will most likely be appealed either to the full bench of the appeals court or to the U.S. Supreme Court.



ASCP Provides Recommendations to CMS on New CLFS Codes, MoPath Code Proposal

On July 18, ASCP submitted its recommendations for new codes to the Centers for Medicare & Medicaid Services (CMS) that will be added to the clinical laboratory fee schedule (CLFS) for 2012. ASCP also attended CMS’s public information session on a new coding proposal for molecular pathology procedures.

During the molecular pathology coding session, CMS announced that it has not made a decision regarding placing the codes on the physician fee schedule (PFS) or CLFS. CMS did mention that it does not plan to place the codes on the CLFS for 2012. CMS did not indicate whether the codes would appear on the CLFS for 2013 or the PFS for 2012. ASCP supports assigning these new codes to the PFS.

During the session devoted to new CLFS for 2012, ASCP recommended that new CPT code 863XX, Nuclear Matrix Protein 22 (NMP22), qualitative, be cross walked to 86294 Immunoassay for tumor antigen, qualitative or semi-quantitative (e.g., bladder tumor antigen). ASCP suggested that new CPT code 873XX. Infectious agent antigen detection by enzyme immunoassay technique, qualitative or semi-quantitative, multiple-step method; HIV-1 antigen(s), with HIV-1 and HIV-2 antibodies, single result, be cross walked to 87390, Infectious agent antigen detection by enzyme immunoassay technique, qualitative or semi-quantitative, multiple-step method; HIV-1 plus one-half 86703 Antibody; HIV-1 and HIV-2, single assay.  



Move over Washington, There's a New Debt Ceiling Proposal in Town
SGR Fix, Provider Payments May Be Exposed to Across the Board Cuts

On July 31, Congressional leaders announced a possible deal on the debt ceiling and are poised to vote Monday or Tuesday on the proposal. The proposal aims to reduce the national debt by as much as $2.4 trillion over 10 years. The proposal would extend the debt ceiling through 2012. Unfortunately for providers, the deal may expose those participating in Medicare to cuts in reimbursement rates.

The spending cuts would occur in two stages. The first round of cuts would require $900 billion in spending cuts over the next 10 years. Most of these cuts would likely occur in future years. The second stage would require a bipartisan Congressional committee to identify $1.2 to $1.5 trillion in cuts by late November. If Congress adopts the Committee’s recommendation, then the debt ceiling will be raised by the amount cut by Congress—up to $1.5 trillion—but if the Committee is unable to agree on a compromise or if Congress does not approve the committee’s recommendation, $1.2 trillion in across-the-board cuts would be imposed, beginning in 2013.

Only a few programs, such as Medicaid, Social Security, veteran’s benefits, etc., are exempt from the $1.2 trillion in across-the-board cuts. As a result, Medicare reimbursement rates could be subject to the across-the-board cuts. The proposal would cap any cuts in Medicare provider reimbursement rates at 2 percent.

The demise of a previous plan proposed by the “gang of six”—a bipartisan group of six Republican and Democratic Senators—is a blow to physicians in that their plan had proposed a 10-year fix to the physician fee schedule’s sustainable growth rate, which is responsible to the annual proposed cuts in reimbursement rates. As a result of the debt debate a permanent fix to the SGR seems even more challenging, possibly requiring that any reverses of SGR-triggered cuts may have to be dealt with through annual fixes.



Political Scientist Comments on the Future of Genomics

While the fight over patents for the BRCA1 and BRCA2 genes continues, the field of genomics may be facing even more political turmoil. Jennifer Hochschild, founding editor of Perspective on Politics, worries that by breaking down genetic code, we may be building up walls of discrimination.

At her July 7 presentation, “The Political Implications of Human Genomics,” Hochschild spoke about her research on the social perceptions of genomics. Hochschild, with her research assistant Maya Sen, has been conducting national surveys to determine the potential impact of increased access to genetic information. Hochschild believes that as the science of genomics emerges onto the public’s radar, whether it’s used to track down potential criminals or to trace a person’s lineage, some may interpret the findings as a new form of racial classification.

Will the use of genetic information in law enforcement be seen as a way to improve investigations or as a way to racially profile? Hochschild has spent a year at the Kluge Center at the Library of Congress conducting surveys and interviews to gain insight on people’s reaction to the use of genomics in areas such as law enforcement and diagnostics. Hochschild worries that genomics will be a politically divisive issue, opening the floodgates for even more debate over the ownership of genetic information.

NCCN Examines Oncology-Related Molecular Testing

Last month, the National Comprehensive Cancer Network (NCCN), an alliance of 21 of the world’s leading cancer centers, hosted a policy summit focused on molecular testing in oncology. The all-day forum featured in-depth discussions of the scientific, clinical, regulatory, and coverage policy issues identified by the NCCN Molecular Testing Work group as “challenges” regarding the utilization and incorporation of molecular testing into clinical practice. The charge of the work group, comprised of multidisciplinary thought leaders representing providers, patients, manufacturers, payers, and government, is to provide guidance to healthcare providers and other stakeholders regarding the challenges of molecular testing.

The overwhelming topic of concern for many of the attendees is the Food and Drug Administration’s (FDA) recently announced plans for oversight of laboratory developed tests (LDTs). The increasing complexity of these assays coupled with an increasing commercial interest in oncology-related LDTs in general, has prompted the FDA to consider whether its longstanding policy of exercising “enforcement discretion” is still appropriate. Elizabeth Mansfield, PhD, Director of the Personalized Medicine in the Office of In Vitro Diagnostic Devices (OIVD) in the Center for Devices, FDA, reported at the summit that the FDA is continuing to look at the ramifications of stepped up regulation very carefully but indicated that “some caveats will remain under enforcement discretion.”

The NCCN work group encourages regulations that will ensure patient access to safe, effective, and efficient molecular test, without limiting the ability of CLIA-certified laboratories to meet the need to develop test for new targeted cancer therapies. In addition, the work group believes that increased education regarding molecular testing in oncology is needed for patients, clinicians, pathologists, industry, payers, and policy makers to help ensure these test are being employed safely, effectively, and efficiently in oncology, and their limitations and the clinical impact of their results are understood.

As a result of the summit, the NCCN plans to publish a white paper that will further detail the challenges and recommendations of the NCCN Molecular Testing Work Group.

Health Professions Coalition Discuss Funding, Advocacy

The Health Professions and Nursing Education Coalition (HPNEC), of which the ASCP is a member, met recently to discuss the budget and appropriations updates from Capitol Hill. According to Tannaz Rasouli of the Association of American Medical Colleges (AAMC), there is a lot going on and nothing happening.

HPNEC is planning to write a letter to the House of Representatives endorsing President Obama’s proposed budget and ask for a substantial increase in funding for nursing and allied health profession training programs. The agenda also covered advocacy activities to take place during the Congressional August recess such as town hall meetings to advocate for and answer questions about healthcare funding in local communities.

The meeting also covered the Health Resources and Services Administration data collection efforts. HPNEC member organizations have begun collecting data about success in programs that are funded by Title VII and Title VIII of the Public Health Services Act. The hope is that an aggregation of this information will provide a persuasive argument for the continuation of funding for these health profession programs.



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