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Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

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XPRIZE Founder Diamandis Predicts Tech Giants Amazon, Apple, and Google Will Be Doctors of The Future

Strategists agree that big tech is disrupting healthcare, so how will clinical laboratories and anatomic pathology groups serve virtual healthcare customers?

Visionary XPRIZE founder Peter Diamandis, MD, sees big tech as “the doctor of the future.” In an interview with Fast Company promoting his new book, “The Future Is Faster Than You Think,” Diamandis, who is the Executive Chairman of the XPRIZE Foundation, said that the healthcare industry is “phenomenally broken” and that Apple, Amazon, and Google could do “a thousandfold” better job.

Diamandis, who also founded Singularity University, a global learning and innovation community that uses exponential technologies to tackle worldwide challenges, according to its website, said, “We’re going to see Apple and Amazon and Google and all the data-driven companies that are in our homes right now become our healthcare providers.”

If this prediction becomes reality, it will bring significant changes in the traditional ways that consumers and patients have selected providers and access healthcare services. In turn, this will require all clinical laboratories and pathology groups to develop business strategies in response to these developments.

Amazon Arrives in Healthcare Markets

Several widely-publicized business initiatives by Amazon, Google, and Apple substantiate these predictions. According to an Amazon blog, healthcare insurers, providers, and pharmacy benefit managers are already operating HIPAA-eligible Amazon Alexa for:

  • Appointments at urgent care facilities,
  • Tracking prescriptions,
  • Employee wellness incentive management, and
  • Care updates following hospital discharge.

For example, the My Children’s Enhanced Recovery After Cardiac Surgery (ERAS Cardiac) program at Boston Children’s Hospital uses Amazon Alexa to share updates on patients’ recovery, the blog noted.

Alexa also enables HIPAA-compliant blood glucose updates as part of the Livongo for Diabetes program. “Our members now have the ability to hear their last blood glucose check by simply asking Alexa,” said Jennifer Schneider, MD, President of Livongo, a digital health company, in a news release.

And Cigna’s “Answers By Cigna” Alexa “skill” gives members who install the option responses to 150 commonly asked health insurance questions, explained a Cigna news release

Google Strikes Agreements with Health Systems 

Meanwhile, Google has agreements with Ascension and Mayo Clinic for the use of Google’s cloud computing capability and more, Business Insider reported.

“Google plans to disrupt healthcare and use data and artificial intelligence,” Toby Cosgrove, Executive Advisor to the Google Cloud team and former Cleveland Clinic President, told B2B information platform PYMNTs.com.

PYMNTs speculated that Google, which recently acquired Fitbit, could be aiming at connecting consumers’ Fitbit fitness watch data with their electronic health records (EHRs).

“Ultimately what’s best is human and AI collaboratively,” Peter Diamandis, MD, founder of XPRIZE Foundation and Singularity University told Fast Company. “But I think for reading x-rays, MRIs, CT scans, genome data, and so forth, that once we put human ego aside, machine learning is a much better way to do that.” (Photo copyright: SALT.)

Apple Works with Insurers, Integrating Health Data

In “UnitedHealthcare Offers Apple Watches to Wellness Program Participants Who Meet Fitness Goals; Clinical Laboratories Can Participate and Increase Revenues,” Dark Daily noted that by “leveraging the popularity of mobile health (mHealth) wearable devices, UnitedHealthcare (UHC) has found a new way to incentivize employees participating in the insurer’s Motion walking program.” UHC offered free Apple Watches to employees willing to meet or exceed certain fitness goals.

The Apple Watch health app also enables people to access medical laboratory test results and vaccination records, and “sync up” information with some hospitals, Business Insider explained.

Virtual Care, a Payer Priority: Survey

Should healthcare providers feel threatened by the tech giants? Not necessarily. However, employers and payers surveyed by the National Business Group on Health (NBGH), an employer advocacy organization, said they want to see more virtual care solutions, a news release stated.

“One of the challenges employers face in managing their healthcare costs is that healthcare is delivered locally, and change is not scalable. It’s a market-by-market effort,” said Brian Marcotte, President and CEO of the NBGH, in the news release. “Employers are turning to market-specific solutions to drive meaningful changes in the healthcare delivery system.

“Virtual care solutions bring healthcare to the consumer rather than the consumer to healthcare,” Marcotte continue. “They continue to gain momentum as employers seek different ways to deliver cost effective, quality healthcare while improving access and the consumer experience.”

More than 50% of employers said their top initiative for 2020 is implementing more virtual care solutions, according to NBGH’s “2020 Large Employers Health Care Strategy and Plan Design Survey.”

AI Will Affect Clinical Laboratories and Pathology Groups

Diamandis is not the only visionary predicting big tech will continue to disrupt healthcare. During a presentation at last year’s Executive War College Conference on Laboratory and Pathology Management in New Orleans, Ted Schwab, a Los Angeles-area healthcare strategist and entrepreneur, said artificial intelligence (AI) will have a growing role in the healthcare industry.

“In AI, there are three trends to watch,” said health strategist Ted Schwab (above) while speaking at the 2019 Executive War College. “The first major AI trend will affect clinical laboratories and pathologists. It involves how diagnosis will be done on the Internet and via telehealth. The second AI trend is care delivery, such as what we’ve seen with Amazon’s Alexa—you should know that Amazon’s business strategy is to disrupt healthcare. And the third AI trend involves biological engineering,” he concluded. (Photo copyright: Dark Daily.)

Schwab’s perspectives on healthcare’s transformation are featured in an article in The Dark Report, Dark Daily’s sister publication, titled, “Strategist Explains Key Trends in Healthcare’s Transformation.”

“If you use Google in the United States to check symptoms, you’ll get five-million to 11-million hits,” Schwab told The Dark Report. “Clearly, there’s plenty of talk about symptom checkers, and if you go online now, you’ll find 350 different electronic applications that will give you medical advice—meaning you’ll get a diagnosis over the internet. These applications are winding their way somewhere through the regulatory process.

“The FDA just released a report saying it plans to regulate internet doctors, not telehealth doctors and not virtual doctors,” he continued. “Instead, they’re going to regulate machines. This news is significant because, today, within an hour of receiving emergency care, 45% of Americans have googled their condition, so the cat is out of the bag as it pertains to us going online for our medical care.”

Be Proactive, Not Reactive, Health Leaders Say

Healthcare leaders need to work on improving access to primary care, instead of becoming defensive or reactive to tech companies, several healthcare CEOs told Becker’s Hospital Review.

Clinical laboratory leaders are advised to keep an eye on these virtual healthcare trends and be open to assisting doctors engaged in telehealth services and online diagnostic activities.

—Donna Marie Pocius

Related Information:

2020 Executive War College on Lab and Pathology Management – April 28-29

Amazon and Apple Will Be Our Doctors in the Future, Says Tech Guru Peter Diamandis

Introducing New Alexa Healthcare Skills

Livongo for Diabetes Program Releases HIPAA-Compliant Amazon Alexa Skill

“Answers by Cigna” Skill for Amazon Alexa Simplifies, Personalizes Healthcare Information

2020 Predictions for Amazon, Haven, Google, Apple

Health Strategies of Google, Amazon, Apple, and Microsoft

How Big Tech Is Disrupting Big Healthcare

Large Employers Double Down on Efforts to Stem Rising U.S. Health Benefit Costs which are Expected to Top $15,000 per Employee in 2020: Employers cite virtual care and strategies to manage high cost claims as top initiatives for 2020

How to Compete Against Amazon, Apple, Google: Three Healthcare CEOS on How to Compete Against the Industry’s Most Disruptive Forces

UnitedHealthcare Offers Apple Watches to Wellness Program Participants Who Meet Fitness Goals; Clinical Laboratories Can Participate and Increase Revenues

Strategist Explains Key Trends in Healthcare’s Transformation

New Player in Market for Laboratory Information System Products Acquires Orchard Software

Sale of respected laboratory information system company may be an early sign that investors believe clinical laboratories and pathology groups are ready to upgrade their LISs and add needed capabilities

In the past 10 years there has been little disruption to the laboratory information systems (LIS) market that clinical laboratories and anatomic pathology groups use. Yet, over that same 10-year period, almost every hospital and physician group practice adopted an electronic health system (EHR), primarily because of federal financial incentives that encouraged such adoption.

For medical laboratories and pathology groups, this widespread—nearly universal—adoption of EHRs by the nation’s hospitals and physicians was disruptive. Labs were required to expend resources building digital interfaces to the EHRs of their parent hospitals and client physicians to support electronic test ordering and test reporting.

However, because that wave of EHR adoption is now over, clinical labs and pathology groups have an opportunity to assess the current state of the health information technology (HIT) that they use daily, primarily in the form of the classic laboratory information system that handles nearly all the primary functions needed to support testing and other operational needs.

This opportunity to help medical laboratories enhance and/or upgrade the capabilities of their laboratory information systems may be one motivation behind the recent sale of a well-known LIS company.

Private Equity Firm Buys Orchard Software

On Oct. 7, 2019, Orchard Software Corporation of Carmel, Ind., announced its acquisition by Franciscan Partners, a private equity firm based in San Francisco.

Orchard Software, founded in 1993, has grown steadily over the past 20 years, primarily by serving physician office laboratories, community hospital labs, and independent clinical laboratory companies. With each stage of growth, Orchard added functionality to its LIS and related software offerings and moved up-market to serve larger hospitals and larger labs.

The purchase price and the terms of the sale were not announced. Orchard’s Founder, President and CEO, Rob Bush, will retire. The new CEO is Billie Whitehurst, who came to Orchard from Netsmart Technologies, where she was Senior Vice President. The remainder of Orchard’s management team will be kept in place.

“Francisco Partners will provide capital and expertise to enable Orchard to grow at a faster pace and continue to develop its newer web-based products in an industry that has lagged behind in adoption of cloud-based software,” says Rob Bush (above), Orchard Software’s Founder and exiting CEO, in a press release. (Photo copyright: Twitter.)

Is the LIS Market Heating Up?

What makes the purchase of Orchard by a multi-billion-dollar private equity company noteworthy is the fact that it is the first significant transaction in the LIS sector probably since the mid-2000s, which saw several significant mergers and acquisitions.

During that period, Cerner Corporation (NASDAQ:CERN) purchased Siemens Health Services and Misys acquired Sunquest information Systems. Then, Roper Technologies purchased Sunquest Information Systems from Mysis. Roper later also acquired PowerPath, an anatomic pathology LIS owned by private equity company Thoma Bravo.

Other acquisitions or investments involving LIS companies need to happen before it would be appropriate to say that investor interest in the LIS sector is heating up. However, it is accurate to say that many professional investors will be watching to see whether Franciscan Partners succeeds with its investment in Orchard Software. If Orchard’s revenue and operating profits increase substantially in the next few years, that may encourage other investors to look for LIS companies and products that they can buy.

If this were to happen, that would be a positive development for both clinical laboratories and anatomic pathology groups, because these investors would have a motive to add new functions and capabilities to their LIS products. It would also wake up a sector of lab information technology that has been relatively quiet for several years.

—Michelle Robertson

Related Information:

Orchard Software Gains Boost from Francisco Partners

Orchard Software to Be Acquired by Private Equity Firm

Francisco Partners to Acquire Orchard Software

Francisco Partners, a Technology-Focused Private Equity Firm, Announced Sept. 30 Its Intent to Acquire Orchard Software

Elekta Sells Its PowerPath Pathology Software to Sunquest

Trends Reshaping Hospitals Worldwide Also Impact Clinical Laboratories and Anatomic Pathology Groups

As hospitals are forced to innovate, anatomic pathologists and medical laboratories will need to adapt to new healthcare delivery locations and billing systems  

As new challenges threaten the survival of many hospitals worldwide, medical laboratories may be compelled to adapt to the needs of those transforming organizations. Those challenges confronting hospitals are spelled out in a recent report from management consulting firm McKinsey and Company with the provocative title, “The Hospital Is Dead, Long Live the Hospital!

A team of analysts led by McKinsey senior partner Penny Dash, MB BS, MSc, looked at nine trends affecting hospitals in North America, Europe, Asia, and other regions. These trends, the authors contend, will force hospitals to adopt innovations in how they are structured and how they deliver healthcare.

Here are nine challenges hospitals face that have implications for medical laboratories:

1. Aging Patient Populations

“Patient populations are getting older, and their needs are becoming more complex,” McKinsey reports, and this is imposing higher cost burdens. The US Census Bureau projects that by 2030 approximately 20% of the US population will be 65 or older compared with about 15% in 2016.

The federal Centers for Medicare and Medicaid Services (CMS) reports that this age group accounts for a disproportionate share of healthcare costs. In 2014, CMS states, per-capita healthcare spending was $19,098 for people 65 or older compared with $7,153 for younger adults.

The Census Bureau graphic above illustrates how the age of the US population is changing. People are living longer, and as Dark Daily reported in May, this could present opportunities for medical laboratories and anatomic pathologists, as early detection of chronic diseases affecting older patients could ultimately reduce treatment costs. (Photo copyright: US Census Bureau.)

2. Patients Are Behaving More Like Consumers

“Patients—along with their families and caregivers—expect to receive more information about their conditions and care, access to the newest treatments, and better amenities,” McKinsey reports.

Dark Daily has reported extensively on the rise of healthcare consumerism and the opportunities this might offer for clinical laboratories.

3. More Community-based Outpatient Care

Clinical advances are increasing the range of treatments that can be performed in outpatient settings, McKinsey reports. The authors point to multiple studies suggesting that patients can receive better outcomes when more care is delivered outside the hospital. Dark Daily has often reported on the impact of this trend, which has reduced demand for in-hospital laboratory testing while increasing opportunities for outpatient services.

4. Move Toward High-Volume Specialist Providers

Compared with general hospitals, specialized, high-volume “centers of excellence” can deliver better and more cost-effective care in many specialties, McKinsey suggests. As evidence, the report points to research published over the past 12 years in specialist journals.

Some US employers are steering patients to top-ranked providers as part of their efforts to reduce healthcare costs. For example, Walmart (NYSE:WMT) pays travel costs for patients to undergo evaluation and treatment at out-of-state hospitals recognized as centers of excellence, which Dark Daily reported on in July.

UnitedHealthcare’s new preferred lab network also appears to be a nod toward this trend. As The Dark Report revealed in April, the insurer has designated seven laboratories to be part of this network. These labs will offer shorter wait times, lower costs, and higher quality of care compared with UnitedHealthcare’s larger network of legacy labs, the insurer says.

5. Impact of Clinical Advances

Better treatments and greater understanding of disease causes have led to significantly lower mortality rates for many conditions, McKinsey reports. But the authors add that high costs for new therapies are forcing payers to contend with questions about whether to fund them.

As Dark Daily has often reported, new genetic therapies often require companion tests to determine whether patients can benefit from the treatments. And these also face scrutiny from payers. For example, in January 2018, Dark Daily reported that some insurers have refused to cover tests associated with larotrectinib (LOXO-101), a new cancer treatment.

6. Impact of Disruptive Digital Technologies

The McKinsey report identifies five ways in which digital technologies are having an impact on hospitals:

  • Automation of manual tasks;
  • More patient interaction with providers;
  • Real-time management of resources, such as use of hospital beds;
  • Real-time clinical decision support to enable more consistency and timeliness of care; and
  • Use of telemedicine applications to enable care for patients in remote locations.

All have potential consequences for medical laboratories, as Dark Daily has reported. For example, telepathology offers opportunities for pathologists to provide remote interpretation of blood tests from a distance.

7. Workforce Challenges

Many countries are contending with shortages of physicians, nurses, and allied health professionals, McKinsey reports. The authors add that the situation is likely to get worse in the coming decades because much of the current healthcare workforce consists of baby boomers.

An investigation published in JAMA in May indicated that, in the US, the number of active pathologists decreased from 15,568 to 12,839 between 2007 and 2017. In January, Dark Daily reported that clinical laboratories are also dealing with a generational shift involving medical technologists and lab managers, as experienced baby boomers who work in clinical laboratories are retiring.

8. Financial Challenges

In the United States and other countries, growth in healthcare spending will outpace the gross domestic product, the McKinsey report states, placing pressure on hospitals to operate more efficiently.

9. More Reliance on Quality Metrics

McKinsey cites regulations in Canada, Scandinavia, and the UK that require hospitals to publish quality measurements such as mortality, readmittance, and infection rates. These metrics are sometimes linked to pay-for-performance programs, the report states. In the United States, Medicare regularly uses quality-of-care metrics to determine reimbursement, and as Dark Daily reported in July, a new Humana program for oncology care includes measurements for medical laboratories and anatomic pathology groups.

The McKinsey report reveals that several trends in healthcare are forcing healthcare leaders to adopt new strategies for success. The report’s authors state that their “results show that contemporary healthcare providers around the world are facing several urgent imperatives: to strengthen clinical quality; increase the delivery of personalized, patient-centered care; improve the patient experience; and enhance their efficiency and productivity.”

These pressures on hospitals typically also require appropriate responses from clinical laboratories and anatomic pathology groups as well.

—Stephen Beale

Related Information:

The Hospital Is Dead, Long Live the Hospital!

The Nine Forces Changing the World for Hospitals

Older People Projected to Outnumber Children for First Time in US History

CMS: Health Expenditures by Age and Gender

Results of Harvard Study into Medicare Costs Offers Opportunities for Clinical Laboratories

Pathology Groups and Clinical Laboratories Have Unique Opportunity to Take Leadership Role in Healthcare Consumerism

Consumer Trend to Use Walk-In and Urgent Care Clinics Instead of Traditional Primary Care Offices Could Impact Clinical Laboratory Test Ordering/Revenue

Walmart Flies Employees to Top Hospitals for Surgeries in a Bid to Cut Healthcare Costs

New UnitedHealthcare Preferred Lab Network Launches July 1

Precision Medicine Requires Targeted Cancer Therapies, but Payers Reluctant to Pay for Some Genetic Testing Needed to Match a Patient with Right Drug

Telemedicine Gaining Momentum in US as Large Employers Look for Ways to Decrease Costs; Trend Has Implications for Pathology Groups and Medical Laboratories

Trends in the US and Canadian Pathologist Workforces From 2007 to 2017

With Experienced Baby Boomers Retiring in Ever-Larger Numbers, Clinical Laboratories and Pathology Groups Use New Methods to Improve Productivity, Reduce Costs

Humana’s New Oncology Value-based Care Program Includes Quality and Cost Measurements of Provider Performance, Clinical Laboratories, and Pathology Groups

Federal Investigations into Alleged Kickback Schemes between Hospitals and Physicians Increase in Number and Scope

Hospitals and other organizations are finding ways to pay physicians for referrals in ways that don’t always look like kickbacks

Hospitals nationwide are being scrutinized by the federal Office of the Inspector General (OIG) for allegedly violating federal anti-kickback statutes. This will be of interest to clinical pathology laboratories that have been under a similar spotlight for various referral-kickback schemes and arrangements in the last few years, which Dark Daily repeatedly covered.

Kaiser Health News (KHN) recently reported on investigations by the OIG into hospitals allegedly offering unusually high salaries and other perks to specialists because they attract highly profitable business.

In the KHN article, titled, “Hospitals Accused of Paying Doctors Large Kickbacks in Quest for Patients,” Senior Correspondent Jordan Rau describes one investigation of salaries that involved certain high-profile specialists at Wheeling Hospital, in Wheeling, W.Va.

Wheeling, KHN reported, paid one anesthesiologist $1.2 million per year, which, Rau notes, is higher than the salaries of 90% of the pain management specialists around the country. Rau went on to describe how Wheeling also paid one obstetrician-gynecologist $1.3 million per year, and a cardiothoracic surgeon $770,000 per year along with 12 weeks of vacation time.

In each of those cases, the whistleblower who prompted the qui tam investigation reported that the specialists’ various departments were frequently in the red, reported KHN.

“The problem, according to the government, is that the efforts run counter to federal self-referral bans and anti-kickback laws that are designed to prevent financial considerations from warping physicians’ clinical decisions,” wrote Rau.

Wheeling not only contests the lawsuits brought against it, but also has filed a countersuit against the whistleblower. KHN said the hospital claims “its generous salaries were not kickbacks but the only way it could provide specialized care to local residents who otherwise would have to travel to other cities for services such as labor and delivery that are best provided near home.”

“We are confident that, if this case goes to a trial, there will be no evidence of wrongdoing—only proof that Wheeling Hospital offers the Northern Panhandle Community access to superior care, [and] world class physicians and services,” KHN reported Gregg Warren (above), Vice President of Marketing and Public Relations at Wheeling Hospital, saying in a statement. (Photo copyright: LinkedIn.)

OIG’s Fraud and Abuse Laws: A Roadmap for Physicians

The KHN article mentions five laws the OIG lists on its website that are particularly important for physicians to be aware of. They include the:

  • False Claims Act: states that it’s illegal to file false Medicare or Medicaid claims.
  • Anti-Kickback Statute: states that paying for referrals is illegal, that physicians can’t provide free or discounted services to uninsured people, and that money and gifts from drug and device makers to physicians are prohibited.
  • Stark Law(physician self-referral): says that referrals to entities with whom the physician has a familial or financial relationship are off-limits.
  • Exclusion Statue: describes who cannot participate in federal programs, such as Medicare.
  • Civil Monetary Penalties Law: authorizes the Secretary of Health and Human Services, which operates the OIG, to impose penalties in cases of fraud and abuse that involve Medicare or Medicaid.

“Together, these rules are intended to remove financial incentives that can lead doctors to order up extraneous tests and treatments that increase costs to Medicare and other insurers and expose patients to unnecessary risks,” KHN said.

Other Hospitals Under Investigation

Wheeling Hospital is not the only healthcare institution facing investigation. The Dallas Morning News (DMN) reported on a case involving Forest Park Medical Center (FPMC) in Dallas that resulted in the conviction of seven defendants, including four doctors. Prosecutors outlined the scheme in court, saying that FPMC illegally paid for surgeries.

“Prosecutors said the surgeons agreed to refer patients to the Dallas hospital in exchange for money to market their practices,” DMN reported, adding “Patients were a valuable commodity sold to the highest bidder, according to the government.” 

One of the convicted physicians, Michael Rimlawi, MD, told DMN, “I’m in disbelief. I thought we had a good system, a fair system.” His statement may indicate the level to which some healthcare providers at FPMC did not clearly understand how anti-kickback laws work.

“The verdict in the Forest Park case is a reminder to healthcare practitioners across the district that patients—not payments—should guide decisions about how and where doctors administer treatment,” US Attorney Erin Nealy Cox told DMN.

Know What Is and Is Not a Kickback

Both the Wheeling Hospital investigation and the Forest Park Medical Center case make it clear that kickbacks don’t always look like kickbacks. Becker’s Hospital Review published an article titled “Four Biggest Anti-Kickback Settlements Involving Hospitals in 2018” that details cases in which hospitals chose to settle.

These four incidents involved hospitals in Tennessee, Montana, Pennsylvania, and New York. This demonstrates that kickback schemes take place nationwide. And they show that violations of the Stark Law, the False Claims Act, and the Anti-Kickback Statute can happen in numerous ways.

Whether in a clinical laboratory or an enterprisewide health network, violating laws written to prevent money—rather than appropriate patient care—from being the primary motivator in hiring decisions, may result in investigation, charges, fines, and even conviction.

“If we’re going to solve the healthcare pricing problem, these kinds of practices are going to have to go away,” Vikas Saini, MD, President of the Lown Institute, a Massachusetts nonprofit that advocates for affordable care, told KHN.

Though these recent OIG investigations target hospitals, clinical laboratory leaders know from past experience that they also must be vigilant and ensure their hiring practices do not run afoul of anti-kickback legislation.

—Dava Stewart

Related Information:

Hospitals Accused of Paying Doctors Large Kickbacks in Quest for Patients

A Roadmap for New Physicians: Fraud and Abuse Laws

Surgeons, hospital owner convicted in massive kickback scheme involving Forest Park Medical Center

Four Biggest Anti-Kickback Settlements Involving Hospitals in 2018

Clinical Laboratory Compliance Practices Under Pressure as Federal Spotlight Is Aimed at Common Fraud and Abuse Schemes; Penalties for Violations Surge

Biodiagnostic Laboratory Services Leaders Sentenced to Prison in $100-Million Lab Test Kickback Scheme That Also Led to Convictions of 38 Physicians Does New Opioid Law Require Clinical Laboratories to Change How They Pay Sales Employees?

Kroger Prescription Plans Partners with Myriad Genetics to Offer GeneSight Genetic Tests and Genetic Counseling in Kroger Pharmacies

Clinical laboratories may soon find opportunities to assist retail pharmacists who are doing genetic test counseling, as employers’ support of genetic testing advances

In another market example of acceptance of genetic tests by major employers, a new pilot program is underway by Kroger Prescription Plans that offers GeneSight by Myriad Genetics as a benefit. GeneSight is an LDT, a laboratory-developed pharmacogenomic test, used to treat psychiatric disorders, such as depression.

As part of the agreement with Myriad Genetics, Inc. (NASDAQ:MYGN), pharmacists at more than 2,300 Kroger stores will offer counseling about GeneSight to eligible employees and coordinate the testing with referring healthcare providers, according to a news release.

Clinical laboratory leaders and clinical pathologists will want to observe these early steps by Kroger to offer genetic tests and genetic test counseling in a retail pharmacy setting. If the GeneSight benefit option and in-store pharmacy interventions prove popular, Kroger Prescription Plans may soon offer other genetic tests, as well.

“Depression is a leading cause of disability and lost productivity in the United States, and only 40% of people reach remission after their first antidepressant medication,” Colleen Lindholz (above), President of Kroger Health, told the Cincinnati Business Courier. “We are committed to helping people combat this debilitating disease, and we’re proud to launch this pilot program. This test can help patients escape the frustrating process of trying multiple medications in the hopes of finding one that works.” (Photo copyright: EatingWell.)

Kroger Not the Only Pharmacy to Offer Genetic Tests and Counseling

Headquartered in Cincinnati, Ohio, Kroger (NYSE:KR) is the largest supermarket chain in the US and the country’s fourth-largest employer. Kroger Prescription Plans—a pharmacy benefit manager (PBM)—provides pharmacy management services and clinical programs to employers, including Kroger, in 32 states. But it’s not the only pharmacy company to offer genetic tests and genetic counseling.

Last year Albertsons Companies and Genomind, a personalized medicine platform, launched Genecept Assay (now known as Professional PGx)—a genetic test designed to help doctors make informed treatment decisions for their mental health patients—as well as pharmacy-based genetic counseling at select Albertsons and its subsidiaries, according to Supermarket News.

Participating locations include:

  • 21 Sav-On pharmacies at Albertsons in Boise, Idaho;
  • Five Jewel-Osco pharmacies in the Chicago area; and
  • Two Sav-On pharmacies at Acme supermarkets in the Philadelphia area.

The Albertsons-Genomind partnership is aimed at patients who may be struggling with a medication for depression, anxiety, obsessive-compulsive disorder, or other mental illnesses. Patients can receive counseling from “specially trained pharmacists” who work with referring clinicians to offer [Professional PGx], noted Supermarket News.

Pharmacists as Genetic Test Counselors?

Pathologists and medical laboratory leaders may be intrigued by the concept of putting pharmacists into the role of a genetic test counselor. However, pharmacists may need to increase their knowledge of pharmacogenomics, reported Drug Topics.

“The science advances in the field are just making it more critical that pharmacists have a really strong understanding of how to blend [pharmacogenomics] into their training,” Kathleen Jaeger, National Association of Chain Drug Stores (NACDS) Senior Vice President of Pharmacy Care and Patient Advocacy, told Drug Topics.

However, some see pharmacists as the natural experts in the space. “In my opinions, [pharmacists] should be the people who own pharmacogenetics. It’s a relatively new field, and who better than pharmacists to optimize drug therapy?” Daniel Dowd, PharmD, Vice President of Medical Affairs at Genomind, told Drug Topics.

Pharmacists will need to be proactive in working with companies that provide genetic testing, according to a Managed Health Care Connect Pharmacy Learning Network analysis, which also indicated billing for pharmacists’ informational services would need to be addressed.

“These opinions about this type of role for pharmacists will not be what pathologists want to hear,” stated Robert L. Michel, Editor-In-Chief of The Dark Report, Dark Daily’s sister publication. “Pathologists have had the role of the ‘doctor’s doctor’ for decades. Pathologists are trained in how to recognize disease, how to determine which medical laboratory tests are appropriate for the symptoms displayed by a patient, and how to interpret the results to select the best therapies.

“Additionally, pathologists are trained to understand the technical performance of clinical laboratory tests, such as whether the sample was of acceptable quality to produce a reliable result, whether the analyzer that produced a result was performing within specifications, and what factors should be considered in tandem with the lab test results when making a diagnosis,” he explained. “It is easy to see why the pathology profession would argue that pharmacists lack this depth of knowledge and experience when ordering and interpreting medical laboratory tests. How the pathology profession will respond to these developments involving pharmacists, interpretation of genetic test results, and counseling patients is not yet clear.”

Opportunities for Clinical Laboratories to Assist Pharmacies

This is not the first time Dark Daily has reported on genetic tests becoming popular as a corporate benefit. In “More Companies Pay for Employees to Have Genetic Tests in a Trend That Brings More Lab Test Volume to Medical Laboratories,” we predicted that genetic test coverage by companies would expand and possibly drive new sources of revenue through increased lab test volume.

Additionally, we suggested, clinical laboratory leaders and pathologists could find opportunities helping others understand the results of the genetic tests.

The recent partnerships between genetic test companies and corporate retail pharmacies suggest that clinical laboratories could benefit from reaching out to pharmacists who are now at a point-of-care and who may be looking to improve their knowledge of pharmacogenomics.

—Donna Marie Pocius

Related Information:

Myriad Announces Coverage Decision by Kroger Prescription Plans for GeneSight

GeneSight GUIDED Study Published in the Journal of Psychiatric Research

Myriad Pushing Ahead with Payers on GeneSight as Data from Large Randomized Study is Published

Impact of Pharmacogenomics on Clinical Outcomes in Major Depressive Disorder in the GUIDED Trial: A Large Patient-and-Rater-Blinded, Randomized, Controlled Study

Albertsons Cos Pharmacies Offer Genetic Testing

Pharmacogenomics and the Future of Pharmacy

Consumer Genetic Testing Pharmacogenomics, a Potential Opportunity for Pharmacists

More Companies Pay for Employees to Have Genetic Tests in a Trend that Brings More Test Volume to Medical Laboratories

Latest AMA Benchmark Survey Shows Number of Physicians Employed by Health Networks Now Exceeds Those in Independent Practice

As physicians continue to re-evaluate their career strategies, clinical laboratories must closely monitor changes to test ordering from formerly self-employed doctors

For the first time, more doctors are employed by health networks than are in private practice. That’s according to a recent report from the American Medical Association (AMA). In a press release, the AMA describes the event as “the continuation of a long-term trend that has slowly shifted the distribution of physicians away from ownership of private practices.”

This trend impacts independent clinical laboratories and anatomic pathology groups because hospital-based physicians have reasons to order tests from in-house medical laboratories. Thus, a reduction in independent self-employed doctors could also mean reductions in test orders from those physicians.

To make its conclusions, the AMA drew on six years’ worth of Physician Practice Benchmark Survey data, gathered from 2012-2018. In its published Policy Research Perspectives report, the AMA describes the findings as “one of the more dramatic changes over this six-year span.”

Independence versus Employment

According to the new release, employed physicians made up 47.4% of all patient care doctors in 2018—an increase of 6% since 2012. Meanwhile, self-employed doctors represented 45.9% of physicians in patient care—down 7% (from 53.2%) since 2012. 

“Due to this swing, for the first time in 2018, there were fewer physician owners than employed physicians,” the AMA researchers wrote in their report.

The AMA has conducted its benchmark surveys every other year since 2012. They are nationally representative surveys of doctors to record employment status, practice size, specialties, and ownership.

“Change continues in the delivery of healthcare and physicians are responding by re-evaluating their practice arrangements. Physicians must assess many factors and carefully determine settings they find professionally rewarding when considering independence or employment,” said Barbara L. McAneny, MD, FASCO, MACP (above), in the AMA news release. McAneny is a board-certified medical oncologist/hematologist, President of the American Medical Association, and CEO/co-founder of New Mexico Cancer Center. (Photo copyright: HMP.)

Who Employs Doctors?

Physicians can be employed by other doctors in physician-owned practices, by hospitals directly, and by hospital-owned medical practices. 

Most, however, work for other doctors, reported Fierce Healthcare. In a summary of the latest AMA survey data, Fierce noted that:

  • 54% of doctors are owners, employees, or contractors in practices owned by physicians—compared to 60% in 2012;
  • 8% of doctors work directly for a hospital—up from 5.6% in 2012;
  • 26.7% of doctors are employed by hospital-owned practices—up from 23.4% in 2012; and
  • 34.7% of doctors work for a hospital or a practice partly owned by a hospital in 2018—up from 29% in 2012.

The AMA partly attributed the increase in employed physicians to age: 70% of doctors under the age of 40 reported as employees in 2018, compared to 38.2% of doctors 55 and over who reported as employed.

Family Practice Physicians Most Likely to Become Employed by Hospitals

Other intriguing data points include the percentages of practice ownership among medical specialties.  

Pathology was not broken out. However, the AMA’s report did state that, “surgical subspecialties had the highest share of owners (64.5%) followed by obstetrics/gynecology (53.8%) and internal medicine subspecialties (51.7%).

“Emergency medicine had the lowest share of owners (26.2%) and the highest share of independent contractors (27.3%). Family practice was the specialty with the highest share of employed physicians (57.4%),” the report concluded.

The AMA researchers also noted that the number of doctors seeking employment in healthcare networks may be decreasing. “The trend away from physician-owned practices and toward working directly for a hospital or for a hospital-owned practice appears to be slowing—more than half of that shift occurred in the first two years of [the benchmark survey] period [2012 to 2018].”

The AMA also noted that the success or failure of accountable care organizations (ACOs) could have an effect on hospital acquisition of private practices. “Should evolving models of care not deliver on their theoretical savings or improvements, that might put a break on consolidation,” the researchers wrote.

It’s critical that clinical laboratories continue to improve the quality and efficiency of outreach services to retain and grow medical laboratory testing business that increasingly may come from health networks versus physician-owned private medical practices.    

—Donna Marie Pocius

Related Information:

2018 Benchmark Survey and Policy Research Perspective (PDF): Updated Data on Physician Practice Arrangements: For the First Time, Fewer Physicians Are Owners Than Employees

Employed Physicians Outnumber Self-Employed

For the First Time, Employed Physicians Outnumber Self-Employed Doctors, AMA Study FindsEmployed Physicians Now Outnumber Self-Employed Doctors

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