Lab Soft News

More Discussion About the Theranos Scientific Advisory Board

In a blog note posted on August 9, 2016, I commented that four of the eight members of the Theranos Scientific and Medical Advisory Board at that time had close links to the AACC such as being past president of the organization or past president of the National Academy of Clinical Biochemistry (NACB), now the Academy of the AACC. Here is a quote from it:..."[T]here may be a ready explanation for the favoritism shown toward Elizabeth Holmes by the AACC. There is not much daylight between four of the eight members of the Theranos Scientific and Medical Advisory Board and the AACC." The next day, I received an email from Janet Kreizman, CEO of the AACC, which I presented in a blog note (see: Janet Kreizman, CEO of AACC, Responds to Previous Blog Notes about Theranos). Here's a quote from her email denying any conflicts-of-interest (COI) and that any member had a role in the invitation of Elizabeth Holmes to speak at the annual AACC meeting:

I want to be clear that no one on the AACC Board of Directors has any kind of financial agreement with Theranos, nor do those on the organizing committee for the meeting. You have noted that four of AACC’s past presidents are members of Theranos’ Scientific and Medical Advisory Board. This is true, but it is certainly not news, since media outlets have been reporting this fact since April. These past presidents -- while respected members of the association -- hold no decision-making authority at AACC and did not have any impact on the decision to have Elizabeth Holmes speak about Theranos’ technology at the AACC Annual Scientific Meeting. This decision was made by the current leadership at AACC.

A recent article in BioSpace commented on the tight-lipped status of the members of the Theranos scientific advisory board (see: The Scientific Advisors at Theranos Won't (or Can't) Talk). Below is an excerpt from it:

Theranos is well-known, or infamously known, for its fierce code of secrecy surrounding its blood-testing and miniature laboratory technologies. Not only does company leadership maintain this code of silence, but apparently that also extends to the company’s new scientific advisory board. Writing for the American Council on Scientific Health, Julianna Lemieux reached out to the members of Theranos’ scientific advisory board through email, but received a one-sentence reply that the members of the board would not discuss any aspects of their role at Theranos.....Theranos added noted scientists and medical officials to its scientific advisory board in April as part of an effort to bolster the company’s reputation and counter concerns about the failings of its technology. When the board was formed, Theranos said the new board members will work alongside company leadership in various areas, including “advising Theranos regarding the full integration of its technology into routine clinical practice, and publication and presentation in scientific journals and at scientific meetings.”

Here's a link to an article about the Theranos scientific advisory board including member names (see: Theranos bolsters scientific board after independent technology review). In the same way that I could not understand why the AACC invited Elizabeth Holmes to speak at the AACC annual meeting, I also can't understand why a lab scientist or physician would serve on the Theranos board after a continuing stream of penalties, sanctions, and warnings from the FDA (see: Theranos voluntarily withdraws Zika blood test from FDA approval). There are two very basic rules for IVD companies and reference labs: (1) generate accurate test results; and (2) respect the rules of the FDA.

Intermountain Healthcare Launches Telemedicine Program with Connect Care

Cleveland Clinic was one of the first large health systems to offer telemedicine visits with its Express Care Online. This was a significant initiative because the Clinic is both an innovative organization and a trendsetter. I believe that other hospital CEOs will soon be put in the position of explaining why they are not following suit. Intermountain Healthcare launched a telemedicine program early this year called Connect Care so I thought that it would useful to look at some of the features of its program.

For one thing, it's powered by American Well which is the same telehealth support company used by the Cleveland Clinic (see: American Well, CVS Health and Cleveland Clinic Partner to Deliver On-Demand Care to Healthcare Consumers). Intermountain also opted for a soft launch for Connect Care, undoubtedly to work out some of the early kinks. Below is a quote about this from its medical director, Dr. William Daines (see: Intermountain Healthcare Launches $49 Telemedicine Visits):

We started a launch with Intermountain employees only. That was February 8, [2016]. It was a great chance for us to solve a few technology problems, to gauge was general interest would be, and also to make sure that our medical protocols and safety mechanisms were working the way we wanted them to. Sometime in the middle of March we went live with SelectHealth members, our allied insurance partner. In April we started with our public marketing campaign, which included lots of different advertising channels; print, outdoor, television, radio, digital. There was also a soft digital campaign that launched at the end of March that was on a few patient-facing websites. 

Both the Cleveland Clinic and Connect Care charge $49 for a visit. The Cleveland Clinic web site explains that this fee covers a ten-minute consultation and that some insurance companies cover telehealth sessions like a regular office visit (see: Cleveland Clinic Express Care Online). For smart phone and tablet users, there is an app that can be downloaded to manage the visit. For laptop and desktop users, a visit can be launched directly using a link on the web site. 

Clearly, telemedicine visits will never expand as a cost-effective way to deliver ambulatory care visits unless and until such visits are covered by Medicare. Intermountain points out on its web site that such visits are not now reimbursed (see: Connect Care Coverage):

Medicare does not currently cover visits in which you are treated at home by a provider via electronic services (telephone or video). Medicare members may choose to see a Connect Care provider but will be responsible for all charges.

On the other side of this question, Chiron Health says that Medicare's telemedicine's reimbursement policy is "nuanced" (see: Medicare reimbursement for telemedicine). If you are interested, you might want to review some of the details of how CMS has navigated telemedicine reimbursement thus far. I suspect that at some point in the near future its payment policy will be less nuanced.

Cerner Emphasizes Population Health but Pay Attention to the Details

Support for  population health is a major strategic goal in the EHR world but what exactly does the term mean? The topic commands considerable mindshare for Cerner which has created a special landing page for for it (see: Population Health). Below is a cut-and-paste of text about how population health is addressed by the company:

Population Health Management is more than an industry buzzword or the next big fad.

It is the shift from solely automating health systems to managing a person’s health. A healthier overall population will maximize patient satisfaction and minimize resource consumption. Getting there requires complete, accurate patient data and meaningfully using that data to engage individuals at all times, exchange information between providers and ultimately drive better outcomes. This shift in perspective will shape the future of health care – one driven by accountability, transparency and value.

I had the idea prior to writing this note that population health encompasses the health status of large patient populations. Note, however, how Cerner defines the term on its web site:...It is the shift from solely automating health systems to managing a person’s health. A healthier overall population will maximize patient satisfaction and minimize resource consumption. According to the company, then, population health addresses the management of individual patients' health. There's nothing wrong with this definition but it seem to me to be distant from the usual public health definition.

This shift from describing and managing the health of populations of patients to individual patients make sense from a business point of view. Hospitals are not reimbursed on the basis of making patient populations healthier. They will continue to be compensated on the basis of achieving favorable outcomes for individual patients as we move toward value-based care (see: Redefining Health Care: Creating Value-Based Competition on Results). EHR vendors like Cerner thus need to offer products that reflect the goals of their hospital customers.

It falls to the public health experts to determine to what extent healthcare systems deliver on their promise of improving the health of large populations (see: Heart disease death rate continues to drop). A purist might say that improving outcomes for individual patients improves public health statistics for the entire population in the long run. However, it seems to me that the term "population health management" in the EHR world has now drifted from what would expect in a historic sense. 

Consolidating E-Presence Initiatives and Technology in Hospitals

We are on the cusp of a broad roll-out of various types of "e-presence" programs in hospitals. Just to get on the same page, here's a definition for e-presence: The act of being "live" online. Whether in an IM exchange, or video, or even email. ePresence is that quality of feeling that the entity at the other end of the exchange is actually there and responding (see: e-presence). I think that one of the common denominators of e-medical video applications is that providers and patients are interacting on a live basis. These e-presence programs and apps will range from relatively low complexity ambulatory visits (see: Details of Cleveland Clinic's MyCare Online Virtual Telemedicine Visits) to telepsychiatry visits (see: Telepsychiatry) to virtual ICU's care in small hospitals from specialists in larger ones (see: Anatomy of a virtual ICU: Study probes teamwork among on-site, remote staff).

The reasons for my optimism about the rapid growth of e-presence initiatives is that they offer the most cost-effective way to deliver medical services to the growing number of health care consumers. The major expenditures for live on-line services involve networks, software to mange the provider/patient interactions, and the cost of retraining healthcare professionals to use this technology. These costs substitute for bricks-and-mortar costs which will always be substantially more and lack the flexibility of e-presence programs. Patients, of course, need their own devices in their homes but many will already own smart phones or tablets. I fully understand that there questions remain regarding telemedicine reimbursement (see: Telemedicine Reimbursement), but I fully expect them to get ironed out quickly.

As these e-presence initiatives emerge within individual health systems, there will be a need to blend them under some type of organizational structure within health systems because the technical infrastructure will be similar or the same for most of them. For example and for most of these initiatives, one common need will be to order lab tests and to view test results  so that they are visible to patients and the physicians delivering services. This note is intended, in part, for my pathology informatics colleagues, suggesting that they take the initiative in developing the technical infrastructure, processes, and organization structures for their own hospital e-presence programs.

Do Integrated Delivery Systems Provide Higher Quality and Less Expensive Care?

I have always been somewhat dubious about the claim that hospital mergers and the development of integrated delivery systems (IDSs) will provide less expensive and higher quality care. A recent article discussed this idea in depth (see: The Downside of Merging Doctors and Hospitals). Below is an excerpt from it:

One approach...[to the fragmentation of healthcare] is to consolidate more of the health care you need in one organization called an integrated delivery system. An I.D.S. owns one or several hospitals and also employs physicians across multiple specialties. It may also provide nursing home and rehabilitation care. In some cases, an integrated delivery system may offer its own health insurance plans. Advocates of this approach claim that the coordinated care an I.D.S. offers is not only better for patients but also reduces duplication and avoids unnecessary services, thus lowering costs. Kaiser Permanente, Intermountain Healthcare, the Mayo Clinic and Geisinger Health System are some of the integrated delivery systems with reputations for high quality and low costs. However, the evidence suggests that an I.D.S. doesn’t always improve patient care and keep costs down. Some studies have found an I.D.S. is more likely to use evidence-based care or is better able to manage care. But other studies offer more mixed conclusions. A study published in Health Services Research found that after Minneapolis-St. Paul area hospitals acquired physician practices, there were small improvements in cancer screening and emergency room use. But it also found more unnecessary hospitalizations. Other research that examined 15 nationally prominent integrated delivery systems found no meaningful differences in the quality of care provided by their flagship hospitals, compared with their main competitors. And it turned out that the I.D.S. hospitals were more costly. A study published last year in JAMA Internal Medicine found that prices paid for outpatient care by private insurers are higher for organizations that employ more physicians, as integrated delivery systems do. One reason is that insurers pay an additional “facility fee” for care provided in a hospital setting, even if the same care could be provided in a community clinic.

Simply having an IDS structure does not guarantee integration of care. It takes far more than this. However, having a single electronic record (EHR) for an IDS can go a long way toward reaching this goal. Unfortunately, there is information clutter in the EHR records, partly due to providers cutting-and-pasting information (see: OIG Says Cut-and-Paste in EHRs Can Lead to Medicare Overcharges; Veteran Clinician Critiques the Current EHR -- Both Good and Bad; Copy-and-Paste Errors with EHRs; Some Possible Solutions to the Problem). 

Large, complex IDS's often deliver higher quality care but at a higher price. The added facility fees mentioned above contribute to this. In the long run, our reimbursement system will continue to largely determine the cost for care. It's going to take some time but value-based-care and MACRA should reduce the cost of care and increase its quality. What is entirely clear is that physicians and IDSs need to work together to reach these goals. It does appear that basing MD compensation on RVUs, as is common in many hospital systems, may in and of itself increase the cost of care. Here's a quote from an article discussing this point (see: The Tangled Hospital-Physician Relationship):

The movement of formerly FFS-based private practitioners to hospital salaried employment is conceptually appealing to policymakers because it seemingly dilutes physicians’ incentive to render more services than patients need, and also offers the potential for better coordinated care. The reality, however, appears to be that salaried employment actually increases health costs. Market pressures have pushed hospital compensation and practice expenses for some specialties far above what they actually generate in cash collections. Losses in excess of $200,000 per hospital employed physician are not unusual, according to the Medical Group Management Association. Hospitals make up the cash losses on the practices by placing their employed physicians on RVU-based incentive compensation formulae....These formulae encourage the employed physician to maximize consultative requests for other specialists, as well to use in-house imaging and laboratory services (which are highly profitable to the hospital). In effect, physician care has become a “loss leader” for the hospital’s profitable diagnostic and surgical services.

Jobs with the Highest Suicide Rates: Farming, Fishing, and Forestry

A recent article addressed suicide rates by occupation (see: Jobs With Highest Suicide Rates Identified). Suicides are a major public health problem in various types of jobs as well as in the military (see: U.S. military suicides remain high for 7th year). Below is an excerpt from the article:

Individuals with jobs in farming, fishing, and forestry have the highest suicide rates, followed by those working in construction, according to an analysis by the US Centers for Disease Control and Prevention (CDC). In 2012, suicide was the 10th leading cause of death in the United States, with roughly 40,000 deaths by suicide reported....From 2000 to 2012, rates of suicide jumped 21%, from 13.3 to 16.1 per 100,000....Suicide rates may be high in these occupations for a number of reasons, including job-related isolation, stressful work environments, and work-life imbalance....In addition, farmers' long-term exposure to pesticides may affect the neurologic system and contribute to depressive symptoms. Workers in installation, maintenance, and repair jobs may also have long-term exposure to neurotoxic solvents. Overall, the lowest suicide rate ― 7.5 per 100,000 ― was among education, training, and library workers. The findings, the investigators note, suggest that men working in farming, fishing, and forestry occupations and women working in protective services occupations may benefit from targeted suicide prevention efforts.They point out that evidence-based suicide prevention strategies implemented in the workplace have the potential to reduce the number of suicides among all occupational groups. On that front, the National Action Alliance for Suicide Prevention (NAASP) Workplace Task Force has developed the Comprehensive Blueprint for Workplace Suicide Prevention, which addresses suicide prevention strategies, such as screening, mental health services and resources, suicide prevention training, life skills and social network promotion, and education and advocacy. 

Here's an interesting general comment about the frequency of suicide from the NAASP web site referenced above (see: Suicide is a serious and preventable public health problem):

Suicide takes life without regard to age, income, education, social standing, race, or gender. Overall, suicide is the 10th leading cause of death for all Americans, the 2nd leading cause of death for adults ages 25-34, and the 3rd leading cause of death for youth ages 15-24. The legacy of suicide continues long after the death, impacting bereaved loved ones and communities. Fortunately, there is strong evidence that a comprehensive public health approach is effective in reducing suicide rates. In fact, suicide rates have been declining among both American youth and elders for well over a decade, two groups on which the nation has focused most. There are other population groups, though, for which the death toll is rising.

It's worth the time to focus on the three major causal factors in suicide noted above: (1) job-related isolation, (2) stressful work environments, and (3) work-life imbalance. All three are certainly common in farming, fishing, and forestry as well as in the military. However, I think that it would be difficult to implement suicide prevention strategies broadly in these industries. They often involve the work of small companies or individuals with thin profit margins and thus not always amenable to public health initiatives. This whole topic needs more attention.

Introduction of the Term "Webside" to Refer to Telemedicine Interactions

I am a great fan of telemedicine. There are many kinks that need to be worked out in the deployment of large-scale telemedicine systems. However, this will be the most important response to the need to deliver quality healthcare on a much larger scale. One aspect of this shift in healthcare is the development of a new vocabulary to describe various aspects of patient-provider interactions on the web. A recent article addressed one of these jargon issues (see: At the 'webside'):

When Kaiser Permanente's emergency room wait times began rising three years ago, Dr. Dennis Truing and a colleague launched a telemedicine program to provide faster access to care for their patients (see: Innovations: Kaiser tests video visits to cut waits). At the time, there weren't many training programs for telemedicine or for developing good “webside” manner, which can greatly improve patients' adherence to treatment. Instead, Truing had to learn on the fly....Like its cousin “bedside manner,” webside manner is a key skill for clinicians involved in telemedicine, experts say. Physicians must proffer an empathetic and compassionate presence to calm fears and provide hope for patients who may be suffering from serious or even not-so-serious illness...[B]edside manner can have a statistically significant impact on patient health, affecting the incidence of obesity, asthma, diabetes, hypertension and osteoarthritis. It can also affect weight loss or blood sugar levels in patients. But clinicians are going to have to rethink how they deliver this important element of their craft as medicine moves deeper into the digital age....Approximately 71% of employers say they will offer telemedicine consults through their health plans by 2017. Investment is growing too; the telemedicine market was worth about $500 million in 2014, but that is expected to balloon to $13 billion in 2020....That's why experts and consultants are encouraging physicians to prepare for virtual visits with appropriate equipment and a well-developed “webside manner,” which includes all the same skills as bedside manner but has a number of its own requirements. Just like during a traditional office visit, clinicians must juggle paying attention to the patient with filling out electronic health records and other forms. It's as important to put patients at ease in a virtual environment as it is in an office.

One of the current major barriers to the establishment of telemedicine programs is the training of physicians and nurses to be comfortable with patient interactions at a distance. There's not a lot of accumulated experience about this topic currently. Farsighted hospital executives understand that one of the fastest ways to gain telemedicine experience is to launch a program and learn by doing. I have only quoted a portion of the article cited above so link to it for more information. It's worth the effort.

One fact is obvious to me, however, about telemedicine. Younger physicians and nurses will probably develop their webside skills faster and better than some of the older members of this group. The former are more accustomed to placing video calls using apps like FaceTime and social media. However, I think that it would also be unrealistic to assume that a physician or nurse who has not cultivated good "bedside manners" can subsequently develop good "webside manners." These are a usually a matter of core personality with the added burden of needing to reach out to a patient with only "screen" contact. 

Steps to Help Ensure a Successful Surgical Procedure

Here's a scenario for your consideration. Let's hypothesize that you are scheduled for elective surgery shortly. You have sought a second opinion and the surgery has been deemed necessary and appropriate (see: Cleveland Clinic TV Advertisement: Get a Second Opinion in Cardiology). You have made inquiries and your surgeon is well trained and has performed your procedure numerous times with the same team. You are in relatively good health, have a normal weight, and are a non-smoker so you do not anticipate any significant post-operative complications. You have health insurance and the cost of your procedure will be covered. Anything else to think about? Well, you might ask about the time of day when your surgery is scheduled. If it's a "follow case" that will be started late in the day, you may be increasing your risk (see: Night Time Surgery 'Doubles Death Risk). Below is an excerpt from this article:

People who undergo surgery at night are twice as likely to die as those operated on during regular daytime hours....The findings...also suggest a higher than usual risk of death among those who have surgery later in the day and in the early evening. The results are based on studying 30-day survival rates for patients at a hospital in Montreal, Canada. Between April 2010 and March 2015, the researchers were able to compile a database of 41,716 emergency and routine operations carried out on 33,942 patients.The operations were classified as taking place either in the daytime between 7.30 am and 3.29 pm; during the evening between 3.30 pm and 11.29 pm; or at night between 11.30 pm and 7.29 am.The researchers found that, after making allowances for assessment of patients' overall health and other factors such as age, those patients operated on in the night were 2.17 times more likely to die than those operated on during regular daytime working hours. Also, patients operated on late in the day were 1.43 times more likely to die than those operated on during regular daytime working hours. The researchers say there may be a number of reasons for why night time surgery is more risky. These include fatigue among medical staff, overnight staffing shortages or treatment delays. 

Scheduling operating room procedures across multiple rooms is a daunting task. Emergency procedures or an overlong operation due to complications can play havoc with the schedule. The same is true for medical procures such as colonoscopies. The findings of the research cited above that there is more risk when surgery is performed later in the day stands to reason. The nerves of surgeons and nurses can get frazzled as the day progresses and this may have an effect on performance.

Generally speaking, elective surgeries are scheduled early in the day. However and particularly at large referral centers with a high surgical volume, there may be a long queue of elective surgeries that lasts until late in the day. It occurred to me that there may be an apt analogy between elective surgery slots and airplane seats. Perhaps it could be possible to reserve an early start time for a patient with "frequent flier" status similar to the most desirable seats in the plane. Just something to think about for hospital executives. Of course, they would not relish the idea that some of their patients are disadvantaged in any way for surgeries that start later in the day.