Mar 20, 2017 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
Critics claim the bill would remove genetic privacy and discrimination protections provided by the 2008 GINA Act and other federal laws and might cause medical laboratories performing these tests to become embroiled in employee-employer disputes
Pathology groups and clinical laboratories are closely watching how society reacts to information that comes from genetic testing. Thus, the groundswell of opposition against a House bill that would require employees participating in workplace wellness programs to undergo genetic testing, and to share the results with their employers or face higher healthcare premiums, will be of particular interest and could impact the pathology industry as a whole.
Could Clinical Laboratories Become Entangled in Employee-Employer Disputes?
The fast-forming public outcry against lifting privacy protections for genetic testing in the workplace provides the medical laboratory testing industry with more evidence that concerns over genetic discrimination remain at the forefront among healthcare consumers, scientists, and medical professionals, despite growing understanding about the medical applications of genetics tests.
“What this bill would do is completely take away the protections of existing laws,” said Jennifer Mathis, JD, Director of Policy and Legal Advocacy at the Bazelon Center for Mental Health Law, in an article published in STAT, a Boston-based life science news site. She says protections provided by the 2008 Genetic Information Nondiscrimination Act (GINA), as well as those included in the 1990 Americans with Disabilities Act (ADA), “would be pretty much eviscerated.”
Privacy versus Healthcare Control
The Preserving Employee Wellness Programs Act (HR 1313¬) is part of the effort by the Republican-led Congress to repeal and replace the Patient Protection and Affordable Care Act (ACA), also known as Obamacare.
The House Committee on Education and the Workforce, which passed the bill on a straight party-line vote on March 8, 2017, said in a statement that HR 1313 would “bring uniformity to the regulation of wellness programs and clarify” that such programs are consistent with existing federal laws.
“All these proposals reflect the principle that individuals should have greater control over their healthcare and the freedom to do what’s best for their families,” Committee Chairperson Rep. Virginia Foxx (R-NC) said in a statement.
Jennifer Mathis, JD, Deputy Legal Director and Director of Policy and Legal Advocacy at the Bazelon Center for Mental Health Law, charges that privacy and other protections for genetic and health information provided by the 2008 Genetic Information and Nondiscrimination Act (Gina) and the 1990 Americans with Disabilities Act (ADA) “would be pretty much eviscerated” by HR 1313. (Photo copyright: Center for Disabilities Studies, University of Delaware.)
Opponents of the legislation claim the bill undermines GINA—which when enacted in 2008 was celebrated as the “first major new civil rights bill of the new century”—by removing genetic privacy and nondiscrimination protections. GINA prohibits employers from using genetic information to hire, fire, or promote an employee. And it bars health plans and insurers from using results to deny coverage or charge higher premiums.
Sixty-nine consumer, health, and medical advocacy organizations¬ have banded together to oppose HR 1313 and ask that “the nondiscrimination protections afforded to all Americans by GINA and the ADA” be preserved. They include:
• The American Academy of Pediatrics (AAP);
• The Association for Molecular Pathology (AMP); and
• The Genetics Society of America (GSA).
“We strongly oppose any legislation that would allow employers to inquire about employees’ private genetic information, or medical information unrelated to their ability to do their jobs, and to impose draconian penalties on employees who choose to keep that information private,” the organizations stated in their March 7 letter to the House Committee.
Prior to the committee approving the bill, The American Society of Human Genetics (ASHG) also went on record opposing HR 1313 for “fundamentally undermining the privacy provisions” of GINA and the ADA.
Law Would Allow Penalties on Employees for Not Cooperating
Privacy concerns are just one issue dogging the legislation. The bill also would allow employers to impose financial penalties of up to 30% of the total cost of an employee’s health insurance plan on workers who do not participate in genetic testing required by their workplace wellness program. Using the Kaiser Family Foundation’s 2016 Employer Health Benefits Survey as a guide, in a press release the ASHG estimated employees could be charged an extra $5,443 in annual premiums if they chose not to share their genetic information.
“If enacted, this bill would force Americans to choose between access to affordable healthcare and keeping their personal genetic and health information private,” Derek Scholes, PhD, Director of Science Policy at ASHG, said in the press release. “Employers would be able to coerce employees into providing their genetic and health information and that of their families, even their children.”
A unnamed spokesperson for the House Committee on Education and the Workforce defended the legislation in an interview with CNBC, claiming opponents were intentionally misrepresenting the bill’s intent.
“Those who are opposed to the bill are spreading false information in a desperate attempt to deny employees the choice to participate in a voluntary program that can reduce health insurance costs and encourage healthy lifestyle choices,” she told CNBC. She pointed to the HR 1313 fact sheet, which states the legislation “reaffirms existing law to allow employee wellness programs to be tied to responsible financial incentives.”
The “existing law” the source is referring to is the Patient Protection and Affordable Care Act (ACA), which the Obama administration made law in 2010 in support of employer wellness programs as part of its push to encourage American’s to take responsibility for their healthcare. As written, the ACA already empowers employers to require employees who wish to participate in their company’s wellness programs to undergo genetic testing, the spokesperson reiterated.
Why Medical Laboratories Should Track the Progress of This Proposed Law
Clinical laboratory managers will want to watch the progress of this proposed legislation. The possibility exists that, if a lab performed a genetic test for a patient, and that patient later got into a dispute with the employer wanting access to those genetic test results, the lab could find itself embroiled in that dispute if the employer took legal action to compel the laboratory to reveal those test results. That scenario is a long way from becoming reality, but it does illustrate why this law, if enacted, could prove troublesome for the nation’s medical laboratories.
At this year’s Executive War College (EWC), which takes place on May 2-3 in New Orleans, a special panel discussion with four attorneys experienced in lab and pathology law will discuss emerging legal and compliance issues that involve medical laboratory testing. This proposed bill and other new genetic testing issues will be among the topics addressed by the attorneys on this panel.
—Andrea Downing Peck
Related Information:
Executive War College Conference on Laboratory and Pathology Management Agenda
H.R.1313-Preserving Employee Wellness Programs Act
Preserving Employee Wellness Programs Act Fact Sheet
Group Opposition Letter
Committee Advances Reforms to Expand Affordable Health Care Coverage for Working Families
House Republicans Would Let Employers Demand Workers’ Genetic Test Results
ASHG Opposes HR 1313, the Preserving Employee Wellness Programs Act Bill would Undermine Genetic Privacy Protections
2016 Employer Health Benefits Survey
Employers Could Demand Genetic Testing Under Congressional Bill
May 4, 2016 | Compliance, Legal, and Malpractice, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations
The Wall Street Journal examines the FDA’s position on LDTs and looks at the pros and cons of LDT regulation by the federal agency
National news coverage over the deficiencies uncovered by Clinical Laboratory Improvement Amendments (CLIA) inspections of the clinical laboratory operated by Theranos in Newark, Calif., may have an interesting consequence that affects all medical laboratories and pathology groups.
Over the past 30 months, Theranos has regularly asserted that its laboratory-developed tests (LDTs) were under review by the Food and Drug Administration (FDA). For example, in an interview published in the December 14, 2014, issue of The New Yorker, Theranos Founder and CEO Elizabeth Holmes stated, “We believe that to realize our vision we must operate at the highest levels of excellence… And the FDA’s stamp of approval is seen as an indicator of the quality of a product.”
Thus, it would be ironic if the problems in the quality of clinical laboratory tests uncovered by federal CLIA inspectors at the Theranos lab facility in Newark was used by the FDA to justify their intent to regulate LDTs. The FDA has already released a report to the public that identified instances where laboratories running LDTs were alleged to have reported inaccurate lab test results to patients and their physicians. (more…)
Apr 14, 2014 | Compliance, Legal, and Malpractice, Laboratory Hiring & Human Resources, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
Leaders from ACLA, AdvaMedDx, CAP, NILA will be at Executive War College on April 29-30 for first medical lab industry debate about the best and worst of the new law
Clinical laboratories will face new financial challenges following passage of a new federal law two weeks ago that makes deep changes in the way Medicare officials will establish prices for the Medicare Part B Clinical Laboratory Fee Schedule (CLFS). Many medical laboratory administrators, hospital lab managers, and pathologists remain unaware of the significant negative financial impact this law will have on their lab’s revenue and fiscal stability.
On April 1, President Barack Obama signed H.R. 4302: Protecting Access to Medicare Act of 2014. The law’s primary purpose is to extend the Sustainable Growth Rate (SGR) formula for 12 months. The House had passed the bill on the previous Thursday and the Senate passed the bill on the following Monday, March 31. (more…)
Jan 21, 2013 | Compliance, Legal, and Malpractice, Digital Pathology, Laboratory News, Laboratory Pathology
Pathologists and clinical laboratory managers will likely learn next year whether Myriad’s gene patents will stand
In the ongoing debate about gene patents, the nation’s highest legal authority is about to weigh in on the question. The Supreme Court has agreed to hear the Myriad Genetics patent case in the upcoming term. The case turns on whether human genes can be patented.
Will Clinical Labs Need to Pay Royalties for Using Human Gene Patents?
How the high court rules on this matter has significant implications for clinical laboratories and pathology groups throughout the United States. That’s because holders of patents on human genes require medical laboratories to pay royalties for the clinical testing they perform. (more…)
Jul 11, 2012 | Compliance, Legal, and Malpractice, Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations, News From Dark Daily
Both pathology profession and biotech industry have much at stake in how Supreme Court rules in this important case involving the patentability of genes
Legal challenges to gene patents are a high interest topic among pathologists and clinical laboratory scientists who perform genetic testing. Two high profile cases involving gene patents were accepted by the Supreme Court. A ruling was made in one case and the second case is continuing.
The Supreme Court issued a ruling in one case, titled Mayo Collaborative Services v. Prometheus Laboratories, Inc. (Prometheus). The dispute centered upon Prometheus’ method patents to testing for metabolites of the drug thiopurine in patients with gastrointestinal disease.
In a unanimous opinion, the Supreme Court ruled that these patents were invalid. Some medical laboratory scientists believe that the ruling could ultimately result in the invalidation of the even more significant gene patents, including those gene patents at issue in Association for Molecular Pathology, et al. v. Myriad Genetics (Myriad)..
New Ruling Has Huge Significance for Pathology and Lab Medicine
According to a story in CAP Today, in the Prometheus case, the court reasoned that a process of recognizing and reciting a law of nature is not patentable because laws of nature are not patentable.
This summer, the Supreme Court will hear oral arguments in the case of Association of Molecular Pathology vs. Myriad Genetics. At issue is the patentability of genes. In March, the Supreme Court ruled unanimously against Prometheus in another case involving gene patents. (Image by PSmag.com)
“We have the first clear statement by the Supreme Court—and by a unanimous Supreme Court—that laboratory testing really amounts to nothing more than an observation about the correlation between an analyte and a particular medical condition is not patentable,” stated Jack Bierig, JD, Partner with Sidley Austin in Chicago, in the CAP Today article.
Bierig observed that the key question presented by Prometheus is where to draw the line between a law of nature and an application of the law. “There is a well-known distinction between laws of nature—which are not patentable; and applications of laws of nature—which are patentable,” he stated. “This is the first Supreme Court case that has addressed that question in the context of laboratory testing.”
The ruling overturned the U.S. Court of Appeals for the Federal Circuit (CAFC) decision which upheld the Prometheus patents.
Prometheus Decision May Render Myriad Gene Patent Claims Invalid
Important questions still remain about the patentability of genes. Just six days following the March 20, 2012, ruling in Prometheus, the Court remanded Myriad to the CAFC for reconsideration under the new ruling. In 2011, the CAFC found in favor of Myriad.
The Myriad case originated in 2009 when several plaintiffs, including the American Civil Liberties Union, filed a lawsuit challenging seven of Myriad Genetics’ (NASDAQ: MYGN) patents on the BRCA1 and BRCA2 genes and methods for interrogating the genes.
The question of gene patentability is of critical importance to pathologists, according to Roger D. Klein, M.D., J.D., a molecular pathologist and Chair of the Professional Relations Committee of the Association for Molecular Pathology (AMP). Klein observed in CAP Today that enforcement of gene patents in Myriad has interfered with pathologists’ ability to provide comprehensive interpretations involving multiple diagnostic test procedures. He asserted that the patents have also prevented pathologists from implementing cost-saving algorithms that reduce unnecessary testing.
“It’s the gene patents that are so universal,” agreed Wayne W. Grody, M.D., Ph.D., Professor of Pathology and Laboratory Medicine, Pediatrics, and Human Genetics at the University of California School of Medicine. “We really care much more about the impact of this case on Myriad and other cases that may come later,” stated Grody, who is also President of the American College of Medical Genetics and Genomics.
Biotechnology in a “Minor Panic” Following Prometheus Ruling
According to a story in The Economist, the biotechnology industry is in a “minor panic” at the implications of the high court’s unexpected ruling in Prometheus.
Klein rejects the biotechnology industry’s argument that patent invalidation will jeopardize the advancement of personalized medicine. “I think it will produce tremendous advancement and accelerate progress,” he stated.
John H. Noseworthy, M.D., President and Chief Executive Officer of Mayo Clinic, agreed. “[The new ruling] will favorably impact patient care because it provides broad access to good-quality bedside testing,” he stated in a story published by The Wall Street Journal.
At this point, oral arguments in the Myriad case are scheduled for this summer. In reconsidering the Myriad case, the CAFC may reverse its previous ruling upholding the BRCA gene patents, Bierig speculated. Or, the case may end up in the Supreme Court for final determination.
“I think there’s a chance that the Supreme Court could now rule that the product of the genome is basically a natural phenomenon,” observed Bierig. Klein agreed, suggesting that the Prometheus decision probably renders the Myriad patent claims invalid.
Pathologists and clinical laboratory managers will want to continue to follow the surprising developments in these clinically-relevant patent cases. The Prometheus decision sent a clear message that the Supremes are positioned on the side of the “medical” rather than “commercial” ethic in the area of genetic patents.
For its part, the biotechnology industry may ultimately have to resort to seeking relief through congressional revision of patent law as it pertains to genes. Of course, it can be expected that the clinical laboratory testing profession would be actively educating Congressman should there be consideration of such legislation.
—Pamela Scherer McLeod
Related Information:
For background on the patent cases:
Decisions in Prometheus, Myriad, and Classen Cases Help Clarify Patent Eligibility Requirements for Genetic Lab Tests and Molecular Diagnostics
By Zeus! Prometheus ruling checks patents
Prometheus unsound: America’s Supreme Court wallops the biotech industry
Top Court’s Patent Rejection Alarms the Biotech Industry
