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DARK Daily Laboratory and Pathology News

DARK Daily is an e-briefing service providing up-to-the minute news of relevance for anyone working in diagnostic medicine, from clinical laboratories and pathology groups to lab industry suppliers and diagnostic technology companies. DARK Daily is part of The Dark Intelligence Group, Inc. and is dedicated to bringing useful business and management intelligence to laboratory managers, pathologists and diagnostic executives. Our recognized expertise in the strategic direction of laboratory medicine and the management of laboratories is available through DARK Daily, The Dark Report, free White Papers, Lab Resource Directory, the Executive War College on Laboratory and Pathology Management, Lab Quality Confab, and strategic consulting services.

Latest E-Briefings

American Clinical Laboratory Association’s Annual Meeting Takes Place in Washington, DC, as Congress Considers First Obamacare Repeal-and-Replace Bill

CMS Director speaks at ACLA meeting; acknowledges that labs are alerting the agency to problems with Protecting Access to Medicare Act (PAMA) private payer market reporting, but did not say whether a delay in implementing either reporting or lab test fee cuts would be possible

WASHINGTON, DC—Last week, it was symbolic that, as members of the American Clinical Laboratory Association (ACLA) assembled for their annual meeting, members of the House of Representatives were preparing to vote on the first of several bills intended to “repeal and replace” the Affordable Care Act.

The symbolism comes from the fact that the nation’s medical laboratories and the United States Congress find themselves at major crossroad. For medical laboratories, the issue is the substantial cuts to Medicare Part B clinical laboratory test fees that are scheduled to take effect on January 1, 2018. Predicted by the federal Centers for Medicare and Medicaid Services (CMS) to be a total cut of $400 million in 2018 alone, many expect these Medicare fee cuts to be the single most financially-disruptive event to hit the medical laboratory profession in 25 years.

There’s a similar make-or-break issue unfolding in Congress. Republicans in the House and Senate are caught up in battles to design and pass a series of bills intended to “repeal and replace” the ACA. At their respective crossroads, it remains unclear which path forward each group will follow. continue reading

Clinical Laboratories Could Soon Diagnose 17 Diseases with a Single Breath Analyzer Test from Israel’s Institute of Technology

The Technion breathalyzer would give pathology groups and medical laboratories unprecedented ability to support physicians in diagnosing and treating cancers, chronic diseases, and other illnesses

Readers of Dark Daily know that several pathology research teams in America and the UK are developing breath analyzer tests that can detect everything from lung cancer to early-stage infections. Clinical laboratories will soon have a plethora of breath-related tests from which to choose. Now there’s a new kid on the block. A breathalyzer test that can detect up to 17 distinct cancerous, inflammatory, and neurological diseases!

Assuming the cost per test was at a competitive level to existing technologies, what would give this new diagnostic system appeal to physicians and patients alike is that it would be a non-invasive way to diagnose disease. Only a sample of the patient’s breath would be needed to perform the assays.

Researchers at the Israel Institute of Technology, or Technion, published the results of their study in ACS Nano, a monthly journal of the American Chemical Society devoted to “nanoscience and nanotechnology research at the interfaces of chemistry, biology, materials science, physics, and engineering.” continue reading

Pathologists and Clinical Laboratories May Soon Have a Test for Identifying Cardiac Patients at Risk from Specific Heart Drugs by Studying the Patients’ Own Heart Cells

Stanford University School of Medicine researchers grew heart muscle cells and used them, along with CRISPR, to predict whether a patient would benefit or experience bad side effects to specific therapeutic drugs

What would it mean to pathology groups if they could grow heart cells that mimicked a cardiac patient’s own cells? What if clinical laboratories could determine in vitro, using grown cells, if specific patients would have positive or negative reactions to specific heart drugs before they were prescribed the drug? How would that impact the pathology and medical laboratory industries?

We may soon know. Researchers at Stanford University School of Medicine (Stanford) have begun to answer these questions. continue reading

House Bill HR 1313 Would Allow Employers to Demand Workers’ Genetic Test Results or Face Up to 30% Increase in Healthcare Premiums

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.)

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

Studies Reveal Workers in HDHPs Pay Significantly Higher Annual Healthcare Costs than Employers and May Utilize Fewer Clinical Laboratory Tests

Consumers respond to high-deductible plans by using less healthcare services, which in turn leads to a decrease in doctor visits and clinical laboratory test orders

Are many Americans avoiding medical treatment because of the high-cost of their health plan deductibles? And if so, will such an underutilization of healthcare affect hospitals, independent medical practices such as pathology groups, and clinical laboratories?

Two separate studies: one a survey co-conducted by the Kaiser Family Foundation and the Healthcare Research and Educational Trust (KFF/HRET), and the other an analysis by the Health Care Cost Institute (HCCI), investigated the dynamics behind trends in the healthcare marketplace leading to these questions. continue reading

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