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Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

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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

Study Finds Occupying Hospital Bed Previously Used by Patient Receiving Antibiotics Increases Odds of Developing C. diff Infection

Latest research provides new opportunities for clinical laboratories to demonstrate how testing can help curb hospital-acquired infections

Pathologists, microbiologists, and other healthcare providers have long been aware that hospital patients taking antibiotics are at higher risk of contracting the potentially deadly Clostridium difficile infection (C. diff). But new research adds an interesting twist to this issue.

Recent research indicates that being a “second user” of a bed may be another risk factor for acquiring the disease. This will give clinical laboratory professionals, microbiologists, and others on the front lines of hospital infection control programs another factor to consider when working to halt the spread of hospital-acquired infections (HAIs).

The recent study was published online in JAMA Internal Medicine. It shows that patients put in a hospital bed previously occupied by someone given antibiotics are 22% more likely to develop the C. difficile infection, even if they do not themselves receive antibiotics. (more…)

Hospitals with Lowest 30-Day Readmission Rates Succeed at Reducing Rates by Improving Care Coordination and Monitoring of Patients After Discharge

Recent studies indicate that high readmission rates often may be due to patient demographics, giving clinical laboratories an opportunity to use lab test results in ways that minimize the need for specific patients to be readmitted

Medicare’s efforts to reduce hospital readmission rates have left most hospitals facing reductions in Medicare payments. However, a recent ranking of hospitals by the Modern Healthcare Data Center indicates that influences other than inferior care—such as patient demographics—can affect 30-day readmission rates.

These findings are noteworthy for pathologists and clinical laboratory managers operating medical laboratories in hospitals and health systems. That’s because readmission rates impact a hospital’s budget. Thus, less revenue can cause hospital administrators to reduce spending for clinical laboratory and anatomic pathology services. (more…)

Patient Healthcare Costs in High-cost States Can Be Double Those in Low-cost States; Clinical Laboratory Tests Are Among Procedures with Greatest Price Fluctuations

Findings of this HCCI study, may increase pressure for more transparency in clinical laboratory and pathology test prices

Consumers in states with high healthcare costs may spend more than twice as much for common medical procedures as patients in other states. That’s a surprise finding in a milestone report from the Health Care Cost Institute (HCCI). The report also revealed that pathology and clinical laboratory tests are among the services with the widest price fluctuations. Prices also were shown to vary significantly within individual states.

The HCCI study is the latest salvo in the battle to provide consumers with healthcare price transparency and likely will increase demands on clinical laboratories and pathology groups to make lab test prices easy to find and understand.

HCCI Report Identifies Wide Variance in Prices of Clinical Laboratory Tests (more…)

New Study Indicates Shopping Tools Alone Might Not Lower Medical Spending, Even Though More Patients Want to Know Prices for Clinical Laboratory Tests and Other Procedures

JAMA study finds that most workers with access to web-based price comparison tools did not use them, nor did they spend less on medical care than other workers

Can shopping tools designed to help patients compare providers (including medical laboratories), quality, and prices, make a contribution to reducing the increase in healthcare costs? A new study suggests that such shopping tools make only modest contributions to controlling the cost of care.

Published May 3 in the Journal of the American Medical Association (JAMA), the study found that only 10% of the 150,000 employees at two large companies offering web-based transparency tools logged on to compare healthcare costs during the calendar year. In addition, providing workers with the ability to shop for healthcare services did not bring down employees’ average outpatient spending. Instead, employees with access to transparency tools spent slightly more than workers who could not price shop.

“Our findings temper the enthusiasm around the idea that price transparency is some sort of panacea … that price transparency alone, coupled with high deductible health plans, are going to lead to reduced spending,” stated Sunita Desai, PhD, a Seidman Fellow in Healthcare Policy at Harvard Medical School who led the study. She was quoted in a Washington Post article. (more…)