Lab Soft News

Some Hospitals Now Offering Price Estimates; More Transparency for "Shoppable" Services

It has been frequently stated that healthcare needs to be more consumer friendly (see: Making Hospital-Based Labs More Consumer Friendly). This applies partly to the pricing of hospital services. In prior blog notes, I have stated that a bill for an inpatient stay has little bearing on the cost of the services for the hospital (see, for example: Coding for Hospital Services; One Reason for the High Cost of Healthcare; Patients' Out-of-Pocket Healthcare Costs Rising; Expect More Consumer Backlash). A recent article indicated that some hospitals are beginning to offer price estimates to help ameliorate consumer dissatisfaction (see: Some hospitals are already offering price estimates). This is a beginning of the process of making hospital billing more understandable and perhaps lower the cost of care by increasing competition. It's a long article so follow the link for more details if you are interested. Below is an excerpt from it:

The CMS...[has] issued several proposed rules that, among other changes, would require hospitals to publish payer-negotiated prices for various services alongside standard gross charges. The goal is to make it easier for patients to understand the cost of a hospital service before accessing care, according to agency leadership. Starting in January 2019, the CMS began requiring hospitals to publish their list of retail charges for healthcare services—a move that's been roundly criticized since patients rarely pay those rates. But under the latest Medicare Outpatient Prospective Payment System proposed rule, the CMS would go a step further by requiring hospitals to publish the negotiated price by specific payer and plan for "shoppable services." The agency defines those as procedures that patients can book in advance, including X-rays, outpatient visits and lab tests as well as bundled services like a cesarean delivery....

Some hospitals and health systems are already offering patients estimates of their out-of-pocket costs, often providing individualized cost projections while masking these negotiated rates. In August 2018, UCHealth launched a tool within its patient portal where patients can view cost estimates for more than 350 procedures and services. At the time, the Aurora, Colo.-based health system didn't think the agency's focus on chargemasters went far enough for providing price transparency....The price estimates tool provides a breakdown of the patient's expected out-of-pocket liability based on the typical cost of the service and a real-time eligibility check with their benefit plan, including identifying how much of the patient's deductible has been met for the year. To get around possible issues with publishing payer-negotiated rates, UCHealth....masks these rates by combining its contractual discount and the insurance payment as a single line in the price breakdown.

It's become quite clear that the publication of hospital chargemaster data will yield few benefits from the perspective of hospital price transparency (see: Hospitals vary in publishing CMS chargemaster prices). I very much like the UCHealth idea referenced above of placing a tool on the patient portal to provide "a breakdown of the patient's expected out-of-pocket liability based on the typical cost of the service and a real-time eligibility check with their benefit plan, including identifying how much of the patient's deductible has been met for the year." After years of hospital CEOs saying that it would be extremely difficult to decipher their bills or predict what services will cost, some of them at least seem to be willing to develop a tool to do just that.

Of even greater interest to me as a pathologist is the CMS plan in the wings to require disclosure of the negotiated price by payer and plan for shoppable services like lab tests and imaging. Historically, test prices have often been greatly inflated to offset hospital losses in areas that are less automated like critical care units and operating rooms. If this proposed plan is executed, healthcare consumers who pay attention to such matters cold potentially choose to order direct-to-consumer (DTC) tests on the web (see: New Definition for DTC Lab Testing Prompted by EverlyWell Business Model). The prices for such tests will always be priced at a lower level than hospital lab testing. In fact, it's possible that some some hospital labs may be permitted to offer DTC tests to consumers in the community. For consumers with high-deductible plans, this may be a perfect way to save money without sacrificing quality.

Integration of Patient-Generated Test Results with Those from Accredited Laboratories

In response to my note yesterday about direct-access-testing (DAT) (see: New Definition for DTC Lab Testing Prompted by EverlyWell Business Model), Andrea Pitkin, Ph.D., commented in the form of a presentation she had made at the last ASCLS annual meeting. She makes a number of important observations that I hope to comment on in upcoming days. For this note, I will address the following point copied from her comment:

How are consumer testing and Patient Generated Health Data (PGHD) integrated and used within the medical record?

Some apps allow upload to the physician's EHR. They should not be comingled with laboratory performed testing as they are different. The largest issue is one of trust. Does the physician trust from a medical and legal perspective, results performed by consumers (who may have invalidated the home pregnancy test when dropped in the toilet) versus health professional performed testing? How are results kept separate in EHR modules and clinical displays? These new methods and perhaps specimens or transcutaneous analysis should have different LOINC codes so all users can identify these differences in health data.

I personally think that it's time for one of the various lab standards/accreditation agencies to begin to grapple with what Andrea refers to as Patient Generated Health Data (PGHD). To what extent should it be be integrated, but not comingled, with test results generated in accredited clinical laboratories? This topic is not always straightforward. For example, patient-generated blood pressure readings may be more accurate than those taken in the physician's office due to white coat hypertension (see: White coat hypertension: When blood pressure rises at the doctor's office). 

It's not too early to begin this PGHD discussion because I and others can already view hospital-generated test results in the MyChart app "powered by Epic" which is accessible on my smartphone. I expect this trend to continue in the "opposite direction" (i.e., transfer of data from the consumer to healthcare providers). Consider, for example, AliveCor's six-lead ECG device generates data that is clinically valid and thus transferable to a patient's cardiologist (see: This is your heart × 6). In terms of some ideas that could be incorporated into standards pertaining to PGHD, I would make the following suggestions:

• I have previously blogged what what I referred to as the "diagnostic results package" (DRP) for each lab result or set of lab results which I likened to the provenance of an antique (see: The "Diagnostic Results Package": A New Way to Envision Results Reporting). This idea is relevant for the current discussion. For example, if a patient were to order a set of tests via the web and they were performed by an accredited national reference laboratory, the DRP would include, at the very least, the lab test results, the name of the performing lab, and the reference ranges by test. The results would need to be in an unalterable format like PDF. Interestingly enough and although ordered by a consumer, these results would have a validity comparable to those generated by a hospital lab.
• Alternatively, the DRP for, say, a home pregnancy test would include the name of the consumer performing the test, the manufacturer of the kit test, and the result. Such a result, performed by the health consumer, would need to be confirmed in an accredited lab.
• There now exists what I will call two domains for the storage/access of health information for a consumer/patient: (1) the hospital controlled EHR domain that is accessible by the patient via the patient portal; and (2) the patient-controlled personal health domain using a smartphone as "command central" and linked to various apps and wearables such as an Apple Watch (see: Smartphones Provide a Key Element in Our Personal Health Management Systems).
• As noted above, a consumer can now transmit selected health data like ECG data to a healthcare professional. There is thus perhaps the need now for a third domain for consumers, a general-propose, personal health data repository in the cloud via which a consumer could provide personal health data access to healthcare providers and other relevant hospital personnel.

New Definition for DTC Lab Testing Prompted by EverlyWell Business Model

A recent article in Dark Daily convinced me that we need a new definition for direct-to-consumer (DTC) lab testing which has also been called direct-access-testing (DAT) (see: Direct-to-Consumer Lab Test Start-Up EverlyWell Puts Clinical Laboratory Tests on Shelves at CVS and Target). Below is an excerpt from the article:

....Julia Taylor Cheek, Founder and CEO of EverlyWell, a well-financed digital health company based in Austin—hopes to build a... disruptive business in the clinical laboratory industry....Cheek is talking about the same primary business strategy of letting consumers purchase their own lab tests....The company has...expanded its product line to offer 35 panels, including first-to-market tests in fertility, vitamins, peri- and post-menopause, and high-risk HPV. In addition, EverlyWell has launched an end-to-end care model for consumers, now offering an independent physician consult and prescription, if appropriate, for select STDs and Lyme Disease testing. All of this is included in an upfront price before purchase....EverlyWell offers home health test kits, priced from $49 to $400 that people can order without a doctor’s prescription and pay for online. Users take their samples (saliva, urine, or a pinprick of blood) with provided lancets and cotton swabs....EverlyWell’s top selling tests are: Food sensitivity-$159; Thyroid function-$159; Metabolism-$89; and Vitamin D deficiency-$99....A physician reviews the test results...[and] reports on test results are electronically accessible through smartphone apps and online web dashboards. 

My prior definition for DTC/DAT lab testing (see: Reinventing Direct Access Testing), and the one generally accepted in the lab industry, has been that blood is drawn in a patient service center and the test is then performed at an accredited reference laboratory. Such testing has been permissible only in states where it was legal for a consumer to order them. The term has usually not been applied to home testing by diabetics using a glucometer (see: Best Glucometers). Neither was it applied to urine tests for pregnancy interpreted at home by the consumer (see: BFP Test Strip Little Bundle). Ditto for HIV testing using oral fluid applied to a test strip (see: Home Tests).

The article above about EverlyWell has prodded me to propose a tentative, new definition for DAT testing: any laboratory test purchased by a consumer and requiring specimens such as blood or urine with the interpretation of the test by the consumer or by an accredited laboratory based on the analysis of the sample submitted to the lab. I think that such an expanded definition for DTC testing will serve us well in the future as new technology enables more sophisticated home testing including new ways to interpret test strip color changes (see: Dipstick Technology Approved by FDA for Urinalysis at Home).

Why Hospital Labs Should Offer Direct Access Testing to Consumers

In a recent article in Dark Daily, the point is made that a high percentage of millennials do not have a relationship with a primary care physician (PCP) (see: JAMA Study Shows American’s with Primary Care Physicians Receive More High-Value Care, Even as Millennials Reject Traditional Healthcare Settings). The article goes on to offer a list of changes that hospital clinical labs could pursue in order to capture more business from millennials and other healthcare consumers and they are listed below:

Dark Daily advises clinical laboratory leaders to consider changes in how they do business to better serve busy consumers. Here are a few ways to appeal to people of all ages who seek value, fast service, and connectivity:

*  Offer walk-in testing with no appointments.

*  Create easy-to-navigate online scheduling tools.

*  Enable patients to request tests without doctors’ orders as the lab’s market allows.

*  Make results quickly available and in easy-to-understand reports.

*  Post test results online for patients to securely access in patient portals.

*  Make it easy to interact with personnel or receive information through lab websites.

*  Collaborate with telehealth providers.

*  Post prices of the most commonly ordered tests.

*  Use social media to promote the lab and respond to online reviews.

This is a very good list and I strongly endorse all of these ways for lab leaders to engage with a greater numbers of consumers but want to emphasize change #3: offering direct access testing (DAT) but only when legal in the specific state. I have posted number of notes about DAT over the years (see, for example: Reinventing Direct Access Testing (DAT); Direct Access Testing; One Facet of the Decentralization of Healthcare Delivery; An Estimate of the Size of the Direct Access Testing (DAT) Market). At present, it's is legal in about 29 states and the District of Columbia  but this number will surely grow because of the power of consumerism (see: Why Healthcare Experts Critical of Direct Access Testing Advise Clinical Laboratories to Take Precautions).

I  want to emphasize here how many of the steps listed above require IT support. Perusing the list, the following fall into this category: online scheduling tools, patient portals, on-line test results, telemedicine, email interactions with consumers, and social media. Every lab thus needs a strong IT team. However, I want to make one additional point here. The character of pathology and lab testing is changing rapidly due to the decline of inpatient admissions, the rise of consumerism in healthcare, and, as noted above, movement away from the traditional physician and hospital-centric healthcare model. The gist of this Dark Daily article is that laboratory leaders need to establish a new and more direct relationship with consumers. One very effective way for this to happen would be to offer DAT services. This would be a radical change from past practices but radical change may soon be a necessary prescription in the healthcare industry.

Questions about the Interpretation of BRCA Testing by 23andMe

Lab testing for the genes that predispose a person to develop cancer is highly complex, both to preform and interpret. For example and relating to BRCA, I have blogged about some of the pitfalls of such testing (see: BRCA Exchange Available on the Web; Understanding BRCA Variants). Here's a quote from this note discussing some of the complexities that are encountered:

It's not known among some healthcare consumers that there are a host of BRCA variants other than the standard ones. Normal BRCA testing looks for three specific genetic variants that are linked to hereditary cancers. Two of these variants — 185delAG and 5382insC — are in the BRCA1 gene. One variant — called 6174delT — is in the BRCA2 gene. A patient may test positive for a variant other than these common ones and it may not be clear under such circumstances what treatment to offer to the patient.

A recent article in the New York Times warns consumers about the fact that the 23andMe BRCA testing may be misleading (see: Don’t Count on 23andMe to Detect Most Breast Cancer Risks, Study Warns ). Below is an excerpt from the article: 

In 2010, Dr. Pamela Munster mailed her saliva to 23andMe, a relatively new DNA testing company, and later opted in for a BRCA test. As an oncologist, she knew a mutation of this gene would put her at high risk for breast and ovarian cancer. She was relieved by the negative result. Two years later, after she learned she had breast cancer, she took a more complete genetic test from a different lab. This time it was positive. A study of 100,000 people released earlier this month suggested that this experience could be widespread. Nearly 90 percent of participants who carried a BRCA mutation would have been missed by 23andMe’s test, geneticists found. 23andMe’s testing formula for this risk is built around just three genetic variants, most prevalent among Ashkenazi Jews. The new study demonstrated that most people carry other mutations of the gene, something many doctors have long suspected....

Dr. Munster said that 23andMe was “not doing anything actively deceptive.” But she is still concerned that many customers do not grasp the limits of mail-in genetic testing. 23andMe now has more than 10 million customers. Even if only a small percentage take the test, that’s thousands who could be misled. Mary-Claire King, a professor at the University of Washington who discovered the region on the genome that became known as BRCA1, had a more blunt assessment of the Food and Drug Administration’s decision to allow the test....“The F.D.A. should not have permitted this out-of-date approach to be used for medical purposes,” Dr. King said. “Misleading, falsely reassuring results from their incomplete testing can cost women’s lives.”

For me, the fundamental question here is whether consumers "can be trusted" to order lab tests and interpret the results without physician intermediation. I have blogged frequently on this subject (see, for example: Comparison of "Traditional" Lab Testing with Direct Access Testing; An Estimate of the Size of the Direct Access Testing (DAT) Market). The excerpt from the article above focuses on an oncologist who seems to have been lead astray by a negative BRCA test from 23andMe, assuming that she was negative for any BRCA variant. I suspect that Dr. Munster was chosen as the focus of this story to make the point that the interpretation of the BRCA test results is so complex that even an oncologist, ordering the test for herself from 23andMe, could misinterpret the result.

I believe that allowing consumers to order certain routine lab tests for themselves is desirable because I also think that it will result in a general improvement in public health. Some people are too busy or not predisposed to visit a physician frequently. For them, ordering lab tests on the web may improve their health status. The pivotal issue in this discussion, then, is how laboratory tests should be reported to consumers. The most complex tests, particularly those requiring complex interpretation, should not be directly available to consumers. Consumers will generally not be lead astray by the performance of common lab tests but must be provided with reference ranges and instructed to seek the help of a physician for results that fall outside of normal ranges and/or when they have symptoms of a disease.

Warren Buffett Compares Cost of Healthcare in the U.S. to a Corporate Tax

Warren Buffett was quoted in a recent article as comparing the cost of healthcare in the U.S. to a corporate tax (see: Forget Taxes, Warren Buffett Says. The Real Problem Is Health Care). This line of reasoning is important because many executives are lobbying the administration for a lower corporate tax rate. Buffett thinks that they should more appropriately be seeking a lower cost of healthcare in order to be able to operate more competitive globally. I think that he's right and we need a broader discussion of this topic. Below is an excerpt from the article:

“The tax system is not crippling our business around the world.".....Mr. [Warren] Buffett, in a remarkably blunt and pointed remark, implicitly rebuked his fellow chief executives, who have been lobbying the Trump administration and Washington lawmakers to lower corporate taxes. In truth, Mr. Buffett said, a specter much more sinister than corporate taxes is looming over American businesses: health care costs. And chief executives who have been maniacally focused on seeking relief from their tax bills would be smart to shift their attention to these costs, which are swelling and swallowing their profits.....In 1960, corporate taxes in the United States were about 4 percent of G.D.P., which is probably the best way to measure the burden on businesses....Today, it is 1.9 percent. In the meantime, health care costs as a percent of G.D.P. have skyrocketed, significantly diverging with those of other industrial countries. Our health care costs stand at 17.1 percent of G.D.P., up from 13.1 percent in 1995.....

That puts the United States at a material disadvantage far beyond the tax differential. And it harms American companies in particular, since they bear such a big share of those costs. Corporations spend $12,591 on average for coverage of a family of four, up 54 percent since 2005....[T]he United States...[should] enact a sort of universal type of coverage for all citizens — perhaps along the lines of the Medicaid system — with an opt-out provision that would allow the wealthy to still get concierge medicine. Our bloated health care system, Mr. Buffett asserted, is the true barrier to America’s world competitiveness as well as “the single biggest variable where we keep getting more and more out of whack with the rest of the world.”

If and when corporate executives come to realize that the cost of healthcare is a form of corporate tax, what should they then do to help bend the cost curve? One recent article suggested that one solution would be to pursue a series of small steps that, in the aggregate, could make a difference (see: How Small Ideas Are Helping to Bend the Health Care Cost Curve). Here are examples of the small ideas cited in the article:

• Lowering treatment costs by reducing the use of anesthesia providers in routine gastroenterology procedures for low-risk patients.
• Changing the payment policy for emergency transportation or ambulance service. Medicare currently pays vast sums for transporting elderly patients to and from the hospital.
• Shifting care from hospital emergency rooms to retail clinics when appropriate.
• Increasing the use of $4 generic drugs to help rein in runaway prescription drug costs.

There is one way that consumers with high-deductible plans or no health insurance can reduce their healthcare costs -- direct access testing (DAT). Using DAT, consumers order lab tests for themselves on the web, perhaps on the basis of advice from their physicians. Most of these DAT companies use the same national reference labs that provide services to physician offices such as LabCorp (see: FAQs: Walk-in Lab's Questions and Answers). For drawing the necessary blood samples, DAT customers will be directed to the LabCorp's patient service centers. The web-based DAT firms usually use LabCorp to as their performing reference lab.

Major Impending Transformation Predicted for Clinical Lab Business Model

The clinical lab industry is on the cusp of a major transformation of the normally accepted business model as a result of the emergence of telemedicine as a common means for delivering ambulatory care. I have been blogging about the advantages of telemedicine for years (see, for example: Insurance Companies Can Use Telemedicine to Enlarge Their Provider Networks). In a recent note addressing megatrends in healthcare, I suggested that telemedicine was one of them and will soon be part of the "new normal" in healthcare delivery (see: Ten Megatrends in Healthcare with Special Emphasis on Ambulatory Care). My prediction was reinforced by a recent futuring article about Kaiser Permanente (see: Taking Bids on the Hospital of the Future). Here is a quote from it pertaining to the growth of telehealth:

Kaiser physicians now handle more patients via telehealth (59 million a year) than they do in person (50 million). Jennifer Liebermann, who runs the [hospital of the future] test facility, says patient feedback guided development of the TV remote system rolling out to a handful of hospitals and helped fine-tune it over the course of two years to make sure it was easy to use. Kaiser rejected at least one system interface, she says, after elderly patients deemed it too confusing.

In three to five years, I think that the majority of ambulatory care patients will commonly engage with their healthcare providers via telemedicine and thus will not be readily available for venipuncture (or finger prick) for specimen acquisition and lab tests. Instead, I think that such patients will be more inclined to visit a patient service center (PSC) or, perhaps even more commonly, a blood collection center in a neighborhood retail drug store. For this reason alone, health systems need to establish remote blood drawing centers in retail drug stores.

Hospitals have been accustomed to relatively high profit margins on their lab testing. This was feasible because outpatients have been a "captive" audience at the time of outpatient visits. It was convenient for them to just walk to the blood drawing center in the ambulatory care building. However, these high margins for even lab testing have been a challenge for patients not covered by health insurance. This is increasingly the case for consumers with high-deductible plans who may seek low-priced direct-access-testing (DAT) which will also be available in retail drug stores.  Although Theranos made many mistakes, one of the positive things achieved by the company was broad publicity about the low cost of DAT.

One more relevant point. Look for more on-site, point-of-care (POC) lab testing in the drug stores in association with blood drawing services. Think of the Quest/LabCorp business model as sophisticated logistics plus large-scale lab testing with the former involving specimen pickup at physician offices plus transportation to large central labs. Perhaps with more efficient, multiplexed POC analyzers in retail drug stores, lab testing in these sites may become more competitive cost-wise with large reference labs. Certainly, test results in an hour or less would result in much higher patient satisfaction with lab testing. The IVD industry needs to deliver POC analyzers with a much lower cost-per-test to satisfy the impending, growing demand for them in retail drug stores.

SonoraQuest Expands Its Presence in Arizona Safeway Stores

One of the more positive aspects of the Theranos "adventure" in Arizona has been that it has paved the way for Sonora Quest Laboratories to expand its direct access testing (DAT) and PSC services in the state (see: Sonora Quest Laboratories and Safeway Expand Highest-Quality Diagnostic Testing to Greater Arizona). Below is an excerpt from an article with more details:

Sonora Quest Laboratories and Safeway ...[is opening] six new Sonora Quest Laboratories Patient Service Centers (PSCs) ...[in] Safeway stores.... throughout Arizona. The new locations in Arizona are in addition to the two PSCs opened in November 2015....The full-service retail locations offer an exceptional patient experience with convenient lab testing services, access to the most accurate and up-to-date diagnostic capabilities and a guest paging system which allows clinic visitors to shop while waiting for their time-slot or appointment. Sonora Quest Laboratories also provides time-saving services such as patient ordered lab tests through My Lab ReQuest and online (plus mobile) appointment scheduling. With quick access to all laboratory test results though the Patient Results Portal at SonoraQuest.com, patients can proactively manage their health and make educated decisions with a health care provider....Whether customers schedule an appointment for a traditional physician ordered test or walk in for a self-ordered testing through My Lab ReQuest, the retail convenience offers an excellent care experience with friendly staff, highly-skilled phlebotomists and accurate testing. 

The best way to understand this development is to state that SonoraQuest has expanded its patient services centers (PSCs) in multiple Safeway stores in Phoenix and beyond. These PSCs are located in proximity to the in-store Safeway pharmacies so that phlebotomists can take advantage of the space used by the pharmacists for administration of IV medications and flu shots. Moreover, a pre-existing Sonora Quest program called My LabReQuest allows consumers to order blood tests for themselves on the web without a physician order and then drop in to a local Safeway for the blood draw. The Sonora Quest/Safeway PSCs thus provide blood drawing services to patients holding a physician lab test order as well as those ordering lab tests for themselves.

The October 17, 2016, issue of the Dark Report (subscription only) makes the following interesting observation in an article entitled PSCs in Safeway Stores Popular with Consumers concerning the localization of high DAT activity in the state of Arizona:

DAT has been available in Arizona for more than two decades. LabXpress was founded in Phoenix in 1989 to provide low-cost lab tests and has a legitimate claim to be the first direct-to-patient low cost lab company. AnyLabTestNow currently operates six franchise locations in Arizona of which four are in the Phoenix Metro.

Perhaps now forgotten is the fact that Quest had entered the DAT business in 2001 and exited in 2006 with a service called QuestDirect and later QuesTest (see: QuesTest Bails Out of the DAT Market). It was obviously not successful at that time but but was a forerunner of events to come. Here is a quote from that note:

Beginning in 2002, QuesTest launched a new strategy for its DAT operations, using retail drug chains and grocery store chains to sell plastic cards representing various types of test panels (e.g., men's health panel). Following the purchase in a retail outlet, the customer would report to a Quest patient service center for venipuncture. Test results were mailed to the customer and could also be obtained on the web site. 

Walgreens was badly burned by its bad experience with Theranos (see: Walgreens Terminates Relationship with Theranos; Will Be Closing Operations at All 40 Theranos Wellness Centers in Arizona). It remains to be seen whether the major Quest competitor, LabCorp, will choose to compete with Sonora Quest in Arizona with its own PSCs with one of the national retail drug store chains (see: LabCorp to Offer Direct Access Lab Testing (DAT) to Consumers). 

Direct Access Testing; One Facet of the Decentralization of Healthcare Delivery

I have come to view direct access testing (DAT) as one facet of the high-level trends of decentralization and disintermediation in healthcare. By this I mean that some portion of healthcare will migrate away from hospitals and physician offices and toward consumers. Allowing consumers to order lab tests for themselves, for example, is one chapter in this narrative. Others include the development of bedless hospitals (see: The Design of Bedless Hospitals Continue to Evolve Based on Cost and Technology), telemedicine visits with healthcare providers (see: Introduction of the Term "Webside" to Refer to Telemedicine Interactions), and the use web search engines to help consumers interpret their symptoms (see: Paging Dr. Google! We Are Waiting for a Second Opinion). In line with all of this is a recent article in the Dark Daily about DAT (see: Why Healthcare Experts Critical of Direct Access Testing Advise Clinical Laboratories to Take Precautions). Below is an excerpt from it:

DAT enables consumers to request medical lab tests from clinical laboratories without doctors’ orders. It is legal in 29 states and the District of Columbia; 13 states require a physician pre-authorization; and nine others limit the number of tests people can obtain, explained a Lab Tests Online statement....For a growing number of medical laboratories and websites offering blood testing to consumers, DAT is a popular customer service. But prior to taking orders from the consumers, some pathologists say it is important to first carefully select the menu of clinical laboratory tests that will be directly available to the public. Opponents also say DAT can lead to confusion among consumers about which tests are appropriate to order. Consumers can often find it challenging to interpret and understand the lab test results. Another source of confusion can be false positives....DAT has grown from a $15-million business in 2010 to a $131-million business in 2015....But just because you can perform a laboratory test, doesn’t mean you should offer it to consumers,” said Robert Stern, MD, Sonora Quest’s Medical Director....Stern noted that though medical laboratory tests for some diseases and conditions are popular among consumers, the test results are “complex” and “difficult to interpret....So, rather than helping to control healthcare costs, this kind of random or unselected testing can drive up costs—even though lab tests as a percentage of overall healthcare spending is relatively low,” Stern noted.

The term disintermediation has been used in relation to the effect of the migration of businesses to the web. It's defined in the following way (see: disintermediation): 

Disintermediation is giving the user or the consumer direct access to information that otherwise would require a mediator, such as a salesperson, a librarian, or a lawyer. Observers of the Internet and the World Wide Web note that these new technologies give users the power to look up medical, legal information, travel, or comparative product data directly, in some cases removing the need for the mediator (doctor, lawyer, salesperson) or at the very least changing the relationship between the user and the product or service provider.

Just think about what computer and smartphone airline apps have done to the travel industry with most consumers now booking their own reservations and avoiding travel agents. Blood drawing stations in neighborhood retail drug stores will disintermediate hospital and reference blood drawing centers. If these same retail drug store begin to deploy point-of-care analyzers and perform common lab tests, the nature of hospital and reference lab testing will be irreversibly changed. This shift will move beyond DAT testing and encompass more physician-ordered lab testing. The view that such disintermediation will drive up lab and healthcare costs does not make sense to me. The cost of DAT testing has historically been far below that charged by hospitals for such services because the latter have included hefty profit margins.

Quest Seeking Amateur Athletes as Clients for Its New Biomarker Business

The majority of clinical lab customers are patients with diseases and the purpose of the testing is to evaluate their status. Another component of the lab client base is wellness testing and disease surveillance. A third component that is now emerging is what I will refer to here as fitness monitoring (see: Quest’s Blueprint Lets Athletes Look Deeper Into Their Performances). Below is an excerpt from an article about this topic:

 ...[Richard Schwabacher] runs Quest Diagnostics’ Sports and Human Performance unit, the medical testing giant’s effort to take a product directly to consumers. Not just any consumers, but endurance athletes willing to spend a lot of money to enhance their performance....Training for and participating in an Ironman [competition] isn’t for the frugal[...;] it can run up to $15,000 a year....Quest is in the early stages of bringing a diagnostic tool called Blueprint for Athletes to those free-spenders. It’s recruited what it calls ambassadors—a couple dozen hard-core weekend warriors who regularly win or place in triathlons and ultramarathons—to test the product. It’s also rolled Blueprint out to consumers in endurance athlete havens including Houston, Denver, and Quest’s home base in northern New Jersey. Blueprint was born in part from an effort with the New York Giants football team, for which Quest became a sponsor in 2013....Quest and the [New York Giants] team doctors would analyze dozens of biomarkers...and offer specific advice. The results, Schwabacher says, were powerful as the athletes saw how they could change behavior and quickly improve their performance on the field by altering their workouts or diets.....Quest started honing Blueprint for serious amateur athletes as a way to help its overall business grow.....On Blueprint’s website, athletes can choose test packages designed to boost endurance, recovery, or nutrition. A clinician at a Quest location draws several vials of blood that are then analyzed. After a baseline test at the start of training, an athlete can come for follow-ups. Some get tested monthly; others check in quarterly. Test results are reviewed by a physician, who will flag anything he or she deems critical. The athlete ultimately gets a report that can be dozens of pages long, with details on everything from vitamin D to platelet count.

I partly trace the roots of this biomarker fitness monitoring to the anti-aging movement which I have blogged about for ten years. Here are some of the key links: Anti-Aging, Longevity Medicine, and Lab Testing; Anti-Aging Medicine as a Major Driver of Complex Lab Testing; Cost of Drugs for Aging Ranks Third Compared to Diabetes and High Cholesterol). An important element of an anti-aging workup by a physician has been to perform a large panel of biomarkers to compare the patient's so-called biologic age with his or her chronologic age. The goal of treatment was to lower the former in relationship to the latter with exercise and often various nutrients, the value of some of which were unproved. Some of the biomarkers used in the anti-aging field were also esoteric and sometimes questionable. 

We now see Quest engaging with a new group of biomarker clients. It's probably of little concern from a business perspective that the number of marathoners and "ironmen" is relatively small. More importantly, Quest is now in the process of trying to better understand the use of "standard" labs tests to assess fitness. This knowledge will be useful not only for athletes but also for the the entire population. Monitoring fitness, which can be viewed as synonymous with wellness, will become just as important as monitoring and measuring disease. Blueprint for Athletes is offered directly to consumers so it's a form of direct-access-testing (DAT) which Quest and its main competitor, LabCorp, have only recently embraced (see: LabCorp to Offer Direct Access Lab Testing (DAT) to Consumers; Sonora Quest Competes with Theranos in Arizona with DAT Services).