News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
Sign In

Retail Chain Pharmacies Add CLIA-Waived Point-of-Care Blood Testing and Other Preventive Health Services to Their In-store Offerings

Independent clinical laboratories may continue to see their customer numbers drop as more consumers choose healthcare delivered in non-traditional locations

More clinical laboratory companies are offering testing in non-traditional locations with non-traditional delivery systems to serve busy healthcare consumers and ambulatory patients. One such company is eTrueNorth, a pharmacy‐based clinical laboratory services network.

The Mansfield, Texas-based company has partnered with Walmart (NYSE:WMT), Winn-Dixie, Kroger (NYSE:KR), and other retailers to offer their employees CLIA-waived point-of-care testing, preventive health services, wellness screenings, and other medical laboratory testing services through its eLabNetwork chain of retail pharmacies.

This is yet another example of a company responding to the public’s demand for convenient healthcare delivery, including clinical laboratory testing.

Pharmacists as Care Givers

eTrueNorth has quietly built a 5,500-location network of independent CLIA-waived laboratories in retail pharmacies. By bringing point-of-care testing to community pharmacies, the company says it can close gaps in healthcare.

“By empowering local pharmacists to administer preventative healthcare screenings and close gaps in care, eTrueNorth is working in partnership with retail pharmacies, self-funded employers, third-party payors and pharmaceutical manufacturers to identify undiagnosed conditions and better manage chronic diseases,” the company’s website states. “By leveraging the accessibility of retail pharmacies, eTrueNorth expands the scope of services provided to consumers to be more effective, of higher quality and, at the same time, enhance the pharmacy’s value as a key participant in a multidisciplinary healthcare delivery model.”

The website states that eTrueNorth’s ePOCT software suite “simplifies administrative processes for CLIA-waived labs that conduct point-of-care testing.” It provides the infrastructure for CLIA-waived laboratories to meet all applicable federal, state, and local regulations. In addition, the company provides documentation to medical professionals as they track compliance with quality-control efforts for diagnostic devices.

In an exclusive interview with Dark Daily, Coral May, eTrueNorth’s CEO, President, and co-founder, said the company’s growth will continue to accelerate.

“In the next few months, we will be adding quite a few more [eLabNetwork locations] because we will be bringing on a couple of other major brands,” May said in a telephone interview.

May explained that all eLabNetwork pharmacies have standing orders for their limited test menu. This means consumers do not need a physician’s order to receive clinical laboratory services. As a result, however, consumers currently cannot submit a claim for the eLabNetwork service to their insurer. This is about to change.

Coral May (above) is CEO and President of eTrueNorth, a pharmacy-based clinical laboratory services network spanning more than 5,500 locations. “With the assistance of local pharmacists, eTrueNorth is making obtaining laboratory testing easier for individuals,” she said in a news release. “By leveraging the convenience of retail pharmacies, consumers are able to fit healthcare into everyday life.” (Photo copyright: LinkedIn.)

Health Plans May Soon Partner with eLabNetwork Pharmacies

May announced that in the second quarter of 2020 eTrueNorth will launch “within several different health plans” the ability “to provide and submit claims for tests that will close quality measures, gaps in care.”

Though May could not yet announce which health plans will be partnering with eTrueNorth, she stated that participating insurers would be communicating with their members directly to steer them to eLabNetwork pharmacies where they can receive CLIA-waived testing.

May previously pointed out that health plans benefit from eTrueNorth engaging plan members at the pharmacy counter and addressing gaps in care ranging from diabetes testing to hypertension control and medication adherence. She cited as example an insurance plan member with diabetes who has not yet had an A1C test for diabetes or needs an microalbumin [urine] test.

“Our goal is to make it easier for individuals to have affordable and increased access to additional healthcare from the convenience of their local pharmacy,” she stated in a news release.

Another of eTrueNorth’s stated objectives is to increase the number of participants in the Center for Disease Control and Prevention (CDC) National Diabetes Prevention Program (National DPP), which was created in 2010 to increase evidence-based, cost-effective interventions that help prevent Type 2 diabetes.

In order for Medicare Advantage-eligible patients to participate in the program, they must have a fasting blood glucose test. eTrueNorth believes increasing access to point-of-care blood testing could boost participation in the DPP.

“The eTrueNorth Voucher Solution is designed to maximize participation in wellness-screening events by providing convenient access to screenings,” May said in a news release. “Local pharmacists are trusted medical providers to the community. The eTrueNorth Voucher Solution allows individuals to obtain the same high-quality, accurate testing at retail pharmacies as they would from their primary-care office.”

How the Voucher Solution Works

The company’s voucher program enables employees who miss onsite wellness screenings, or who work remotely, to visit a local pharmacy to obtain point-of-care testing and on-the-spot counseling.

Through eLabNetwork’s website, an employee can confirm eligibility, choose a pharmacy based on zip code, schedule an appointment and create a voucher. In addition, the eLabNetwork transmits results to the wellness plan and/or patient’s physician, invoices wellness plan vendors, and sends payments to participating pharmacies for:

  • Full lipid panel;
  • Glucose;
  • Hemoglobin A1C testing (for individuals already diagnosed with diabetes); and
  • Common vaccines.

The company has experienced rapid expansion, most recently adding the Kroger Family of Companies, Giant Food Stores, Food Lion, and Stop and Shop to its growing list of retail partners, a 2019 eTrueNorth Sell Sheet states.

“With 95% of the US population living within five miles of a retail pharmacy, eTrueNorth envisions a future where consumers can access healthcare,” May said in a company statement. “This expanding list of retail pharmacies has the potential to make a significant impact on how healthcare is delivered.”

Will independent clinical laboratories be affected by these events? Almost certainly. Dark Daily has reported often on the public’s increasing demand to receive healthcare in convenient, nearby locations, such as shopping malls and retail pharmacies. This is just another example of that expanding trend.

Lab leaders will want to keep a close eye on it and plan accordingly. It’s a trend that could potentially threaten clinical laboratories’ bottom lines.

—Andrea Downing Peck

Related Information:

Southeastern Grocers Partner with eTrueNorth to Launch CLIA-Waived Laboratory for Point-of-Care Testing at Local Pharmacies

eTrueNorth Creates Retail Pharmacy Network of CLIA-Waived Laboratories for Point-of-Care Testing

eTrueNorth Launches National Voucher Solution Enabling Wellness Screenings at Retail Pharmacies

eTrueNorth: Fitting Wellness into Everyday Life

Walgreens, CVS Add New Healthcare Services and Technology to Their Retail Locations; Is Medical Laboratory Testing Soon to Be Included?

Quest Diagnostics and LabCorp Ink Deals to Put Patient Services Centers in Grocery Stores and Retail Pharmacies, But Not for the Same Reasons as Theranos

Americans Are Using Convenient Care Clinics in Retail Settings

Clinical Laboratories Under Pressure: Exploring Options to Re-establish Critical Relevancy and Maintain Independence

Clinical Laboratories Under Pressure: Exploring Options to Re-establish Critical Relevancy and Maintain Independence

Clinical Laboratories Under Pressure: Exploring Options to Re-establish Critical Relevancy and Maintain Independence

Powerful forces are reshaping the clinical laboratory industry, making 2020 a critical year as hospitals determine whether retaining the laboratory in-house or selling it is the better path.

Mergers, acquisitions, and joint ventures, along with the development of new testing technologies are but a few of the factors that have changed the profile of the medical laboratory footprint across the U.S. And now, downward reimbursement reform combined with impending integration of clinical care, promise to again challenge the traditional laboratory service model in significant ways beyond 2020.

As a clinical laboratory leader, it is important for you to understand why selling the laboratory will not solve core problems like overutilization, low-value testing, inappropriate use of high-cost testing, and provider confusion over best test choice which can lead to irrelevant results and the need for a repeat study. Rather, when you take action to build value within your lab, the result is to sell significant change to the organization in the form of a reinvented, reinvigorated, test-optimized lab.

To assist clinical labs and their leaders in rationalizing the laboratory’s value and relevance in ways that support lab value plus appropriate and high-quality patient care, fiscal strength, and program integrity for payers, DARK Daily is pleased to offer this FREE White Paper—“Clinical Laboratories Under Pressure: Exploring Options to Re-establish Critical Relevancy and Maintain Independence”—the first publication of a three-part White Paper series developed in collaboration with Mayo Clinic Laboratories and Change Healthcare.

Providing rich industry perspective, commentary, and insights on the use and value of decision support in building an effective laboratory stewardship program, the paper also highlights case-study proof points developed in collaboration with Mayo Clinic from early-adopter hospital laboratories—points that have successfully implemented third-party decision support to their value advantage.

 


This White Paper provides a concise discussion regarding:

  • Why establishing the relevance of the clinical laboratory is more important than ever before, especially with the integration of care delivery and the shift away from fee-for-service payments
  • How retaining the clinical lab and committing to effective stewardship through better laboratory test utilization can positively impact not only clinical outcomes and financial performance, but also the viability of the organization as a whole
  • Learn the three evidence-based categories of good stewardship—and the three critical stewardship functions you should integrate into your lab operations plan
  • Address clinical laboratory waste through stewardship: four core test utilization patterns to monitor in order to identify gaps in care, and to develop your own specific strategies to manage overall test utilization
  • Gain insights into stewardship strategies that have worked for other laboratories, and how they have been able to reduce per-patient per-day tests, manage inappropriate test ordering, more effectively utilize and redirect lab staff, and much more!


Table of Contents

INTRODUCTION

Chapter 1: Industry Update: Commoditization of Common Tests Puts Clinical Laboratories
Under Pressure to Validate Value

Chapter 2: Critical Factors That Make Stewardship Work Toward Clinical Laboratory Value
and Value-Based Initiatives

Chapter 3: Addressing Clinical Laboratory Waste Through Stewardship: 4 Core Categories and Early Results

CONCLUSION

 

Increasing the clinical laboratory’s value to a hospital organization does not begin by reducing or selling the lab. Armed with the knowledge within this White Paper, you’ll learn how you can effectively transform your lab into a strategic unit that drives clinical and financial value for itself and for the organization it serves.

Learn more by downloading your FREE copy of “Clinical Laboratories Under Pressure: Exploring Options to Re-establish Critical Relevancy and Maintain Independencenow.


Produced in partnership with:

change-healthcare-logo

Download the White Paper now by completing the form below.

Access to some white papers may require registration. In exchange for providing this free content, we may share your information with the companies whose content you choose to view. By accessing the white paper, you’re agreeing to our Terms of Service and Privacy Policy.







Yes! Sign me up for Dark Daily's E-Briefing Service!

Proteomics May Hold Key to Understanding Aging’s Role in Chronic Diseases and Be Useful as a Clinical Laboratory Test for Age-related Diseases

Researchers are discovering it’s possible to determine a person’s age based on the amount of protein in the blood, but the technology isn’t always correct

Mass spectrometry is increasingly finding its way into clinical laboratories and with it—proteomics—the study of proteins in the human body. And like the human genome, scientists are discovering that protein plays an integral part in the aging process.

This is a most interesting research finding. Might medical laboratories someday use proteomic biomarkers to help physicians gauge the aging progression in patients? Might this diagnostic capability give pathologists and laboratory leaders a new product line for direct-to-consumer testing that would be a cash-paying, fast-growing, profitable clinical laboratory testing service? If so, proteomics could be a boon to clinical laboratories worldwide.

When research into genomics was brand-new, virtually no one imagined that someday the direct-to-consumer lab testing model would offer genetic testing to the public and create a huge stream of revenue for clinical laboratories that process genetic tests. Now, research into protein and aging might point to a similar possibility for proteomics.

For example, through proteomics, researchers led by Benoit Lehallier, PhD, Biostatistician, Instructor of Neurology and Neurological Sciences, and senior author Tony Wyss-Coray, PhD, Professor of Neurology and Neurological Sciences and co-director of the Stanford Alzheimer’s Disease Research Center at Stanford University in California, gained an understanding of aging that suggest intriguing possibilities for clinical laboratories.

In their study, published in Nature, titled, “Undulating Changes in Human Plasma Proteome Profiles Across the Lifespan,” the scientists stated that aging doesn’t happen in a consistent process over time, reported Science Alert.  

The Stanford researchers also found that they can accurately determine a person’s age based on the levels of certain proteins in his or her blood.

Additionally, the study of proteomics may finally explain why blood from young people can have a rejuvenating effect on elderly people’s brains, noted Scientific American.

Each of these findings is important on its own, but taken together, they may have interesting implications for pathologists who follow the research. And medical laboratory leaders may find opportunities in mass spectrometry in the near future, rather than decades from now.

Three Distinct Stages in Aging and Other Findings

The Stanford study found that aging appears to happen at three distinct points in a person’s life—around the ages 34, 60, and 78—rather than being a slow, steady process.

The researchers measured and compared levels of nearly 3,000 specific proteins in blood plasma taken from healthy people between the ages of 18 and 95 years. In the published study, the authors wrote, “This new approach to the study of aging led to the identification of unexpected signatures and pathways that might offer potential targets for age-related diseases.”

Along with the findings regarding the timeline for aging, the researchers found that about two-thirds of the proteins that change with age differ significantly between men and women. “This supports the idea that men and women age differently and highlights the need to include both sexes in clinical studies for a wide range of diseases,” noted a National Institutes of Health (NIH) report.

“We’ve known for a long time that measuring certain proteins in the blood can give you information about a person’s health status—lipoproteins for cardiovascular health, for example,” stated Wyss-Coray in the NIH report. “But it hasn’t been appreciated that so many different proteins’ levels—roughly a third of all the ones we looked at—change markedly with advancing age.”

Tony Wyss-Coray, PhD (above), Professor of Neurology and Neurological Sciences at Stanford University, was senior author of the proteomics study that analyzed blood plasma from 4,263 people between the ages 18-95. “Proteins are the workhorses of the body’s constituent cells, and when their relative levels undergo substantial changes, it means you’ve changed, too,” he said in a Stanford Medicine news article. “Looking at thousands of them in plasma gives you a snapshot of what’s going on throughout the body.” (Photo copyright: Stanford University.)

Differentiating Aging from Disease

Previous research studies also found it is indeed possible to measure a person’s age from his or her “proteomic signature.”

Toshiko Tanaka, PhD, Research Associate with the Longitudinal Study Section, Translational Gerontology Branch, National Institute of Aging (NIG), National Institute of Health (NIH), Baltimore, led a study into proteomics which concluded that more than 200 proteins are associated with age.

The researchers published their findings in Aging Cell, a peer-reviewed open-access journal of the Anatomical Society in the UK, titled, “Plasma Proteomic Signature of Age in Healthy Humans.” In it, the authors wrote, “Our results suggest that there are stereotypical biological changes that occur with aging that are reflected by circulating proteins.”

The fact that chronological age can be determined through a person’s proteomic signature suggests researchers could separate aging from various diseases. “Older age is the main risk factor for a myriad of chronic diseases, and it is invariably associated with progressive loss of function in multiple physiological systems,” wrote the researchers, adding, “A challenge in the field is the need to differentiate between aging and diseases.”

Can Proteins Cause Aging?

Additionally, the Stanford study found that changes in protein levels might not simply be a characteristic of aging, but may actually cause it, a Stanford Medicine news article notes.

“Changes in the levels of numerous proteins that migrate from the body’s tissues into circulating blood not only characterize, but quite possibly cause, the phenomenon of aging,” Wyss-Coray said.

Can Proteins Accurately Predict Age? Not Always

There were, however, some instances where the protein levels inaccurately predicted a person’s age. Some of the samples the Stanford researchers used were from the LonGenity research study conducted by the Albert Einstein College of Medicine, which investigated “why some people enjoy extremely long life spans, with physical health and brain function far better than expected in the 9th and 10th decades of life,” the study’s website notes.

That study included a group of exceptionally long-lived Ashkenazi Jews, who have a “genetic proclivity toward exceptionally good health in what for most of us is advanced old age,” according to the Stanford Medicine news article.

“We had data on hand-grip strength and cognitive function for that group of people. Those with stronger hand grips and better measured cognition were estimated by our plasma-protein clock to be younger than they actually were,” said Wyss-Coray. So, physical condition is a factor in proteomics’ ability to accurately prediction age.

Although understanding the connections between protein in the blood, aging, and disease is in early stages, it is clear additional research is warranted. Not too long ago the idea of consumers having their DNA sequenced from a home kit for fun seemed like fantasy.

However, after multiple FDA approvals, and the success of companies like Ancestry, 23andMe, and the clinical laboratories that serve them, the possibility that proteomics might go the same route does not seem so far-fetched.

—Dava Stewart

Related Information:

Our Bodies Age in Three Distinct Shifts, According to More than 4,000 Blood Tests

Fountain of Youth? Young Blood Infusions ‘Rejuvenate’ Old Mice

Undulating Changes in Human Plasma Proteome Profiles Across the Lifespan

Blood Protein Signatures Change Across Lifespan

Plasma Proteomic Signature of Age in Healthy Humans

Stanford Scientists Reliably Predict People’s Age by Measuring Proteins in Blood

Advancements That Could Bring Proteomics and Mass Spectrometry to Clinical Laboratories

Might Proteomics Challenge the Cult of DNA-centricity? Some Clinical Laboratory Diagnostic Developers See Opportunity in Protein-Centered Diagnostics

Amazon Care Pilot Program Offers Virtual Primary Care to Seattle Employees; Features Both Telehealth and In-home Care Services That Include Clinical Laboratory Testing

Experts say Amazon could be planning a roll-out of healthcare services to its Prime members and others

Clinical laboratory leaders will want to note that the Telehealth and home healthcare industries have expanded with the launch of Amazon Care, a virtual medical clinic and home care services program from global retailer Amazon.com, Inc. (NASDAQ:AMZN).

Amazon is piloting Amazon Care as a benefit for its 53,000 Seattle-area employees and their families, according to published reports. Could this indicate the world’s largest online retailer is moving into the primary care space? If so, clinical laboratory leaders will want to follow this development closely, because the program will need clinical laboratory support.

Amazon has successfully disrupted multiple industries in its corporate life and some experts speculate Amazon may be using its own employees to design a new medical delivery model for national roll-out.

The S&P report goes on to state, “In as little as five years, the Seattle-based e-commerce company could interlink its system of capabilities and assets to launch various healthcare products, insurance plans, virtual care services, and digital health monitoring to a broader population. The rollout would be part of a larger plan by Amazon to deliver convenient, cost-effective access to care and medications across the U.S., likely tied to Amazon’s Prime membership program, according to experts.”

Modern Healthcare reported that Amazon Care services include telemedicine and home visits to employees enrolled in an Amazon health insurance plan.

Experts contacted by S&P Global Market Intelligence suggest Amazon:

  • Plans a “suite of customized health plans and services for businesses and consumers;”
  • May offer health services to its five million seller business and more than 100 million Amazon Prime members; and
  • Sees healthcare as a growing market and wants greater involvement in it.

How Amazon Care Works

Amazon Care offers online, virtual care through a downloadable mobile device application (app) as well as in-person home care for certain medical needs, such as:

  • Colds, allergies, infections, and minor injury;
  • Preventative consults, vaccines, and lab tests;
  • Sexual health services; and
  • General health inquiries.

Becker’s Hospital Review reported that once a participant downloads the Amazon Care app to a smartphone or tablet and signs up for the program, he or she can:

  • Communicate with healthcare providers via text or video;
  • Plan personal visits if needed;
  • Set payment methods in their user profile; and
  • Receive a “potential diagnosis” and treatment plan.
The graphic above is taken from the S&P Global Market Intelligence report, which states, “Amazon is one of several tech firms vying for a share of the healthcare market where national spending is expected to reach $6.0 trillion by 2027, up from $3.6 trillion in 2018, according to the Centers for Medicare and Medicaid Services.” (Graphic copyright: S&P Global Market Intelligence.)

“The service eliminates travel and wait time, connecting employees and their family members to a physician or nurse practitioner through live chat or voice,” an Amazon spokesperson told CNBC, “with the option for in-person follow-up services from a registered nurse ranging from immunizations to instant strep throat detection.”

The “mobile health nurse” may also collect clinical laboratory specimens, the Verge reported.

Amazon has partnered with Oasis Medical Group, a family primary care practice in Seattle, to provide healthcare services for Amazon Care patients.

Paving the Way to Amazon Care

The Healthcare Financial Management Association (HFMA) compares Amazon’s piloting of Amazon Care to similar healthcare projects that studied population health by first involving employee health plans.

HFMA’s analysis noted that Amazon Care is similar to Haven, a patient advocate organization based in Boston and New York that was created in 2018 by Amazon, JPMorgan Chase, and Berkshire Hathaway to lower healthcare costs and improve outcomes for participating companies.

Tech Crunch reported that in 2018 Amazon also purchased PillPack for nearly $1 billion and integrated its prescription delivery services into Amazon Care. 

More recently, Amazon acquired Health Navigator and plans to bring those offerings to Amazon Care as well, CNBC reported. Founded in 2014, Health Navigator provides caregivers with symptom-checking tools that enable remote diagnoses.

Should Telemedicine Firms Be Nervous?

Dark Daily recently reported on Doctor on Demand’s launch of its own virtual healthcare telehealth platform called Synapse. The e-briefing also covered Doctor on Demand’s partnership with Humana (NYSE:HUM) to provide virtual primary care services to the insurer’s health plan members, including online doctor visits at no charge and standard medical laboratory tests for a $5 copayment.

So, should telemedicine firms be concerned about Amazon competing in their marketplace? Business Insider predicts Amazon will need time to beef up its medical resources to serve people online and in-person through Amazon Care.

But that’s the point of Amazon’s pilot, isn’t it? What comes from it will be interesting to watch.

“Meanwhile, telemedicine firms can ink strategic partnerships and strengthen their existing payer relationships to safeguard against Amazon’s surge into the space,” Business Insider advised.    

It remains to be seen how medical laboratory testing and reports would fit into an expanded Amazon Care health network. Or, how clinical laboratories will get “in-network” with Amazon Care, as it grows to serve customers beyond Amazon’s employees.

As Dark Daily recently advised, medical laboratory leaders will want to ensure their lab’s inclusion in virtual care networks, which someday may include Amazon Care.

—Donna Marie Pocius

Related Information:

Amazon Pilots Virtual Health Clinic for Employees

Amazon Could Roll Expanded Healthcare Plans, Services into Prime: Experts

National Health Expenditures Data

Amazon Launches Amazon Care, A Virtual Medical Clinic for Employees

Amazon is Now Offering Virtual Care to its Employees

Six Glimpses into the Amazon Care App, Employees’ ‘First Stop for Healthcare’

Analysis: Implications for Providers as Amazon Offers its Employees Access to a Virtual Clinic  

Amazon Acquires Health Navigator for Amazon Care, its Pilot Employee Healthcare Program

Amazon Acquires Digital Health Start-up Health Navigator

Amazon Piloting a Virtual Care Platform as the Company’s Next Big Step into Healthcare

As Primary Care Providers and Health Insurers Embrace Telehealth, How Will Clinical Laboratories Provide Medical Lab Testing Services?

Hospital Associations and Healthcare Groups Battle HHS Efforts to Expand Pricing Transparency Rules to Include Negotiated Rates with Payers

In a federal lawsuit, seven healthcare organizations and hospitals systems allege HHS exceeded its statutory authority and clinical laboratories will want to watch how this court case unfolds

There is quite a brouhaha over the final new federal rule requiring hospitals to allow patients and the public to see the prices they charge for services—including clinical laboratory and anatomic pathology prices. Some very influential hospital associations and healthcare systems are opposing implementation of this rule.

For more than a decade, Dark Daily has reported on the federal government’s efforts to enact pricing transparency in healthcare. In many e-briefings, we advised pathologists and medical laboratory leaders that the outcome of those efforts will likely affect clinical laboratory workflows and bottom lines, and that many clinical laboratories are not prepared to negotiate directly with customers over the price of their services.

Now, the federal Centers for Medicare and Medicaid Services (CMS) has passed a final rule (CMS-1717-F2) that expands on an earlier rule mandating pricing transparency for hospital procedures—including medical laboratory and anatomic pathology services. This new rule requires hospitals to disclose not only their chargemaster prices, but also prices negotiated with payers.

Hospital leaders are not pleased by this, and though the final rule does not go into effect until January 1, 2021, they are already pushing back through representative organizations such as the American Hospital Association (AHA), which has brought a lawsuit to federal court that seeks to overturn the new rule.

New Transparency Rules Include Rates Negotiated with Health Insurers

Beginning Jan. 1, 2019, CMS required hospitals to disclose chargemaster prices to customers. These are essentially the “list prices” for hospital procedures. However, as Dark Daily reported in “California Healthline Report Finds Hospital Chargemaster Prices Fluctuate Dramatically Even Among Hospitals Located Near Each Other,” June 12, 2019, there were problems. Chargemaster prices typically do not reflect the actual fees charged to patients or payers. Thus, consumers still found it problematic to price shop before committing to healthcare.

In an effort to remedy this, the new 2020 final rule expands the pricing information hospitals are required to provide and includes several categories of prices negotiated with health insurers.

Simultaneous to this final rule, CMS also announced a proposed rule (CMS-9915-P) titled, “Transparency in Coverage,” that if passed, will require health insurers to disclose pricing for healthcare services as well.

In a federal Department of Health and Human Services (HHS) press release, the Trump Administration stated that both rules will “increase price transparency to empower patients and increase competition among all hospitals, group health plans, and health insurance issuers in the individual and group markets.”

“Under the status quo, healthcare prices are about as clear as mud to patients,” said CMS Administrator Seema Verma in the HHS press release. “This final rule and the proposed rule will bring forward the transparency we need to finally begin reducing the overall healthcare costs.”

AHA Sues HHS in Federal Court

In response, four hospital organizations and three health systems filed a lawsuit in federal court against the HHS. The suit alleges the final rule “exceeds the agency’s statutory authority,” and violates the First Amendment by requiring public disclosure of prices negotiated with payers. This information, they say, is “highly confidential and commercially sensitive.”

The plaintiffs include the:

In court documents, the plaintiffs argue that “the Final Rule is arbitrary and capricious and lacks any rational basis. The agency’s explanation for the Final Rule runs counter to both logic and evidence. In fact, it is belied by the agency’s own research regarding what patients care about most when selecting a hospital: their own out-of-pocket costs. The agency’s justification for the Final Rule therefore does not stand up to even the barest of scrutiny. That is the epitome of arbitrary and capricious agency action.”

A brief filed by the plaintiffs contends that patients’ actual out-of-pocket costs are determined by a complex set of factors and aren’t reflected in negotiated rates. In addition, the brief states, “the sheer burden of compliance with the rule is staggering, and way out of line with any projected benefits associated with the rule.”

Charles N. Kahn III (above), President and CEO, Federation of American Hospitals (FAH), said in an AHA press release that, “CMS’ final rule fails to offer patients easy-to-understand information regarding their out-of-pocket obligations for care, so we feel obligated to contest the regulation. We contend the agency exceeded its authority and should go back to the drawing board.” (Photo copyright: FAH.)

Details of the Final Rule on Hospital Price Transparency

If it goes forward, starting Jan. 1, 2021, the final rule requires hospitals to disclose five types of standard charges, according to the HHS and AHA press releases:

  • The chargemaster rate, also known as the gross charge;
  • The discounted cash price, which CMS defines as the amount the hospital will accept from self-paying patients;
  • The payer-specific negotiated charge, defined as “the charge that the hospital has negotiated with a third-party payer for an item or service.” This would be the charge that applies if a patient uses an in-network provider;
  • The maximum charge negotiated with payers; and
  • The minimum charge negotiated with payers.

Hospitals must list these charges for all billable “items and services,” including medical laboratory and pathology services, in a machine-readable format, such as a CSV file that can be opened in a spreadsheet program.

In addition, they must provide a “consumer-friendly” list of charges for at least 300 “shoppable services,” defined as services that consumers can schedule in advance. Each list would include 70 services specified by CMS and an additional 230 services selected by the hospital.

The CMS-specified shoppable services include 14 laboratory and pathology tests. They include:

  • Basic metabolic panel
  • Blood test, comprehensive group of blood chemicals
  • Obstetric blood test panel
  • Blood test, lipids (cholesterol and triglycerides)
  • Kidney function panel test
  • Liver function blood test panel
  • Manual urinalysis test with examination using microscope
  • Automated urinalysis test
  • PSA (prostate specific antigen)
  • Blood test, thyroid stimulating hormone (TSH)
  • Complete blood cell count, with differential white blood cells, automated
  • Complete blood count, automated
  • Blood test, clotting time
  • Coagulation assessment blood test

Blood Brother Clinical Laboratories Also Affected by Price Transparency

Price transparency is also at the center of two federal lawsuits involving Laboratory Corporation of America (LabCorp) and Quest Diagnostics. The Dark Report, Dark Daily’s sister publication, reported on these suits in “Lawsuits Alleging Overcharges to Proceed in Two Courts in 2020,” December 16, 2019.

The plaintiffs in those cases are uninsured or underinsured customers who claim they were charged far more for medical laboratory tests than customers covered by insurance. In both cases, customers were charged at the chargemaster rates. The plaintiffs contend that the medical laboratories should have disclosed their rates in advance.

Whichever way this all goes, clinical laboratories will need to monitor the multiple efforts by the states and the federal government to make it easy for patients to see the prices of hospital, physician, and other medical services in advance of treatment. This has the potential to be a disruptive trend, particularly for hospitals.

—Stephen Beale

Related Information:

Hospitals Sue HHS Over Negotiated Price Disclosure Rule

Hospitals Vary in Publishing CMS Chargemaster Prices

Providers Critical of CMS Price Transparency Push in Pay Rule

Verma: Chargemaster Rule Is ‘First Step’ to Price Transparency

Trump’s Transparency Executive Order Leaves Details to HHS, CMS

CMS May Not Have Power to Make Hospitals Disclose Negotiated Prices

HFMA Summary Negotiated Rate Posting Requirement CY 2020 OPPS Proposed Rule

Rules Issued on Disclosure of Hospital and Health Plan Negotiated Rates

Joint Statement from National Hospital and Health System Groups on Public Disclosure of Privately Negotiated Rates Final Rule

Hospital Groups File Lawsuit Over Illegal Rule Mandating Public Disclosure of Individually Negotiated Rates

Presidential Executive Order Promoting Healthcare Choice and Competition Across the United States

Trump Administration Announces Historic Price Transparency Requirements to Increase Competition and Lower Healthcare Costs for All Americans

Lawsuits Alleging Overcharges to Proceed in Two Courts in 2020

Latest Push by CMS for Increased Price Transparency Highlights Opportunities and Risks for Clinical Laboratories, Pathology Groups

;