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
Mar 16, 2017 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
Every medical laboratory ready to begin the move away from fee-for-service payment and towards value-based reimbursement needs to start offering lab tests that support the practice of precision medicine
Nearly every clinical laboratory and pathology group in America today is aware of the opportunity to provide medical laboratory tests that enable physicians to successfully practice precision medicine. The goal of precision medicine is to enable a patient to get a more accurate diagnosis, receive the most appropriate therapy, and have his/her condition monitored with unprecedented insight during the course of treatment.
The good news for the clinical laboratory industry concerning precision medicine is that it is the fastest-growing sector of lab testing and these are the tests that contribute the greatest value in patient care. For example, molecular and genetic tests are revolutionizing the diagnosis and treatment of infectious disease. These are the clinical lab tests that enable a physician to identify the specific subtype of the bacteria or virus, then help him or her select the therapeutic drug that will have maximum benefit for the patient.
Clinical Laboratories Support Cancer Diagnosis with Companion Diagnostic Tests
It is equally true that the diagnosis and treatment of cancer is undergoing a major transformation. Genetic knowledge is being used to develop both diagnostic tests and new therapies that enable physicians to better diagnose cancer, and then treat it with the drugs identified by a companion diagnostic test as having the best potential to cure the patient or slow the progression of the disease.
But if there is an area of precision medicine with immense potential, it is pharmacogenomics and its associated testing.
In 2015, the Kaiser Family Foundation reported that more than four billion prescriptions were filled in the United States. As science understands more about the human genome, proteome, metabolome, and microbiome (to name just a few of the “omes”), it becomes possible to design clinical laboratory tests that:
1. Contribute to a more accurate diagnosis;
2. Identify which prescription drugs will be of the greatest benefit; and
3. Inform the physician as to which drugs will not be effective and may even be harmful to the patient.
More Good News for Medical Laboratories
There is even more good news. Many clinical laboratories, hospital labs, and pathology groups already have lab instruments capable of performing the tests used in precision medicine. For these labs, no major up-front investment is needed to begin offering tests that allow physicians to practice precision medicine.
“Many of our lab clients got started in this way,” stated Don Rule, MBA, Founder and Chief Executive Officer of Translational Software in Bellevue, Wash. “They realized that their existing lab instruments could run some of the lab tests physicians use when practicing precision medicine. This would be a low-cost way to enter the precision medicine field and they could, on a small scale with minimal risk, begin offering these tests to gain experience, learn more about the market, and identify which such tests would have highest value to the physicians in the communities they serve.”
Is Your Pathology Group Interested in Supporting Precision Medicine?
“For a lab that is serious about understanding the current and future clinical demand for precision medicine tests, several careful steps are recommended,” he continued. “One step is to build demand by educating clinicians and their staffs about the best ways to use these tests to improve patient care. Keep in mind that more of a physician’s reimbursement is now keyed to the patient outcomes they deliver. These doctors recognize that labs helping them do a better job with precision medicine are also helping them demonstrate greater value in the patient care they provide.
“There are other steps required to launch an effective, clinically successful precision medicine testing program,” Rule noted. “For example, labs need to understand how to be paid by the health insurers in their region. That includes getting in-network and teaching physicians and lab staff how to follow each payer’s clinical and coding criteria so that clean claims will be paid in a timely manner.
“Another step is to build the market in a careful fashion,” he emphasized. “For example, labs should identify the thought leaders among their clients and work with them to demonstrate the clinical utility of tests performed in support of precision medicine. And above all, it’s important to focus on patients that are most likely to get some insight from testing. When your lab starts with the right population, it’s remarkable how often you will uncover actionable issues.”
Clinical Labs Can Enter Precision Medicine by Initially Referring Tests
“It’s also feasible for a lab to start its precision medicine strategy by referring out testing in the early stages and using third-party experts to do the interpretations,” Rule advised. “Then, as specimen volume increases, and the lab’s clinical team gains more experience with these molecular and genetic tests, it becomes easy to bring that testing in-house to develop the market further with faster turnaround times and in-house expertise that local physicians appreciate.”
Every clinical lab, hospital lab, and pathology group that is considering how to support precision medicine will want to participate in a special webinar, titled, “What Molecular and Genetic Testing Labs Need to Know to Succeed with Commercialization of Their Precision Medicine Products.” It will take place on Wednesday, March 22, 2017 at 1 PM EDT.
Two expert speakers will cover the essentials that all labs should know about building a market presence in precision medicine. First to present is Don Rule of Translational Software. Rule currently provides a variety of services to more than 80 lab clients, which includes the annotation and interpretation of gene sequences. In addition, Rule and his team provide consulting expertise to help labs develop their strategies for precision medicine, identify the best tests to offer physicians, and develop the steps needed to obtain network status with payers.
Webinar Will Present the Best Successes of Molecular, Genetic Testing Labs
Rule will share the experiences and best successes of the molecular and genetic testing labs he has worked with since 2009. He will discuss the types of lab tests used in precision medicine in different specialties, identify the fastest-growing sectors, and note which instruments already found in most clinical laboratories can be used to provide lab tests used for precision medicine.
Don Rule (above left), Founder and CEO of Translational Software, and Kyle Fetter (above right), Vice President of Advanced Diagnostics at XIFIN, will share their unique insights, knowledge, and experience at developing a precision medicine lab testing program for clinical laboratories that want to build more market share, make the billing/collections team more effective, and increase revenue. (Photo copyright: Dark Daily.)
As one example, a growing number of long-term care facilities are using tests to practice precision medicine—and paying for these tests under value-based arrangements—because so many of their patients are taking from 10 to 15 prescriptions each day. If a lab test indicates that the patient may not be getting therapeutic benefit from a specific drug (or that there are negative side effects from the polypharmacy), then the long-term care facility is money ahead because of less spending on drugs and the decreased care costs from patients who remain healthier. In the extreme case, the care facility might lose a patient to a skilled nursing facility due to mental fog or a fall that is precipitated by adverse drug effects.
Making the Case for a Precision Medicine Lab Testing Program
Additional topics to be discussed are:
• How to make the case to administration and the clinicians;
• How to build demand; and
• How to identify thought leaders and work with them to educate the physicians in the lab’s service region.
The second speaker will address the important topic of how to get paid. Kyle Fetter, MBA, is Vice President of Advanced Diagnostics at XIFIN, Inc., based in San Diego. XIFIN provides revenue cycle management (RCM) services to more than 200 labs and handles as many as 300 million lab test claims annually. What this means is that Fetter sees which labs are most successful with their coding, billing, and collections for molecular and genetic tests. He also sees how different payers are handling these claims.
During his presentation, Fetter will provide you and your lab team with valuable knowledge about the best ways to collect the information needed to submit clean claims and be paid promptly. He will illustrate ways to optimize the process of gathering this data and the different software tools that not only make the job easier, but help ensure that a higher proportion of claims are clean and paid at first submission.
Secrets of Preparing for Payer Challenges, Denials, and Audits
But the single best element of Fetter’s presentation will be how labs performing molecular and genetic testing should prepare, as part of the normal course of business, for the inevitable challenges, denials, and audits. He will describe the elements of a system that helps labs be ready to make the case that claims are properly documented, and that they represent appropriate and necessary tests for the patient.
You can find details for this important webinar at this link. (Or copy this URL and paste it into your browser: https://www.darkdaily.com/webinar/what-molecular-and-genetic-testing-labs-need-to-know-to-succeed-with-commercialization-of-their-precision-medicine-products.)
This webinar is perfect for any lab that is already performing molecular and genetic tests, and which is interested in building more market share, making the billing/collections team more effective, and increasing revenue.
For every lab watching the precision medicine space, this webinar is a “must attend” because it delivers to you and your lab team the collective knowledge and insights from two experts who are working with hundreds of the nation’s most successful labs. It is your guaranteed way to get the accurate, relevant information you need to craft your own lab’s strategy for expanding its molecular and genetic testing opportunities.
—Michael McBride
Related Information:
Genetic Tests and Precision Medicine Start to Win Acceptance by Some Payers; Pathologists and Clinical Laboratories Have Opportunity as Advisors
Dec 30, 2016 | Compliance, Legal, and Malpractice, Laboratory News, Laboratory Operations, Laboratory Pathology, Managed Care Contracts & Payer Reimbursement
In this second installment of a two-part briefing, the impact of the Affordable Care Act on healthcare spending by businesses and consumers during the past eight years is assessed
No single piece of legislation during the Obama Administration generated more controversy than the Affordable Care Act (ACA), which became law in 2010. It was touted by proponents within and without the administration as the needed solution to the nation’s healthcare problems.
The two biggest problems with healthcare in the United States are probably the sustained year-over-year growth in total healthcare spending and the large number of Americans who lack adequate health insurance. At the time that the ACA was signed into law by President Obama, there were assurances that this law would help solve both problems.
Thus, at the end of the Obama Administration’s eight years in office, both academic experts and journalists are writing their assessment about how the ACA has changed healthcare in the United States. This is a high-interest subject for medical laboratories and pathology groups, hospitals and health systems, and physicians. (more…)
