Monday, July 4, 2016

Retail Based Medical Clinics

There is a debate in the American Academy of Pediatrics about what position to take vis-a-vis Retail Based Clinics (RBCs).  Yes, some argue, there are certainly problems with them, but they are here and not going away, so shouldn't we work with them and try to make them as good as possible?  I don't agree with this.  I think there are structural flaws that will make their quality always unacceptable, most probably, especially when dealing with sick kids.  I also think that dealing with them "because they're here" is not a great argument.  Do the Republicans think they can control Trump if he wins?  What about the gamble of Franz von Papen?

Anyway, the AAP came up with a draft paper that I didn't like.  So I criticized it, and then, so as not to just be negative, I thought the responsible thing was to come up with a substitute that I thought would do a better job.  It's a little long, almost 4,000 words, sorry about that.  But I like it, and maybe you will, too.  If you're a non-medical person, hell, just skip it!

Budd Shenkin

                   Proposed AAP Position Paper: Retail Based Clinics

Retail based clinics (RBCs) have proliferated as a new venue for providing health care to patients in the United States.  Since their founding in 20xx, they have proliferated to the point where most major retail pharmacy companies host them in their stores, and the number of visits is up to xxxx in 20xx.  While most visits are for adults, children are also seen.  The best estimate is that xxxx pediatric visits were made to RBCs in 20xx.  The original intention was for RBCs to see patients for acute problems only.  Recently, however, there has been mission creep, and RBCs are advertising other services such as immunizations and care for chronic problems, although it is not clear how much these new services are for adults and how much for children.

The RBC movement is clearly a major one.  Offering care in a different setting is similar to a new technology, and as such, deserves attention and evaluation.  The AAP is dedicated to protecting and promoting the health of children.  It is important for the AAP, therefore, to provide guidance to patients and to the nation on this new development. 

Because of the newness of this movement and the dearth of evaluative studies, no definitive judgement is possible at this time.  We can, however, describe the need that this movement has responded to, describe the settings and the approach of RBCs, and analyze what problems might arise, and what we see as the responsibilities of this new industry.  In doing so we will concentrate on children, and not delve into the implications of RBCs for adult health.

The Need

First, it is important to ask why RBCs have been initiated.  It would appear that RBCs have emerged both as a solution to a problem – lack of access to acute medical care – and from the lure of profit to commercial entities.

It is certainly true that patients with acute problems have had difficulties accessing primary care providers.  This is particularly true for adult patients, and indeed, RBCs were created initially to serve adults rather than children, because as adult primary care practices have focused on chronic disease, obtaining appointments even during regular office hours has often been difficult, and obtaining care out of hours even more so.  As a result, emergency departments (ED's) in hospitals now serve primarily non-emergency patients, waits are long, and prices are very high. 

By contrast to adult practices, pediatric practices do routinely serve patients with acute problems.  Virtually all pediatric private practices and clinics routinely make room for call-in appointments each day they are open for business.  Many are open on Saturdays, and most make provisions for out of hours telephone triage.  Many practices see patients on Sundays, some in evening hours, and increasingly practices provide extended hours care in mornings and evenings, and some accept walk-in patients.  It is true, however, that many practices present barriers to easy access, allowing telephone calls to pile up, requiring long waits in the clinic or office, and providing appointments at times inconvenient for patients. 

It can certainly happen, for instance, that if a child is sick during the night, parents are faced with the need to await the opening of the office, calling the office for an appointment, receiving one for later in the day, arranging emergency child care, leaving for work and then leaving from work to transport a child to the office and back, visiting the pharmacy, and then returning to work or not – all in service of an appointment that may well last all of five minutes.  Pediatric ED's are often poor alternatives, with long waits and high costs.  Thus, in some parts of the country and with some practice arrangements, just on a logistical basis, one can certainly understand the choice of a family to visit an RBC.

The Response

One of the strengths of the American economic system is the ability of commercial enterprises to respond to an opportunity for profit.  The gap between need and supply for acute care services has provided just such an opportunity.  RBC's solve an access problem when a home practice is closed, and sometimes even when it is open.  For the company that owns the RBC, the service not only can produce a profit directly in itself, but the colocation of medical services with pharmacy and other unrelated products can generate even more.  The commercial enterprises have reduced their costs by providing not physicians, but less-expensive Advanced Practice Nurses (APN) as providers, utilizing care algorithms for guidance, and apparently supplying physician guidance at a distance.  Since the main objective of RBCs is adult care, no specifically pediatric providers are generally utilized.

The Questions

While the American system provides innovation, what is not supplied automatically is quality evaluation.  Patients can judge availability and affordability and make other such general consumer judgements, but they cannot judge the scientific aspects of medical quality.  This, then, is the big question: is this innovative method of service provision of sufficiently high quality to be safe and effective for children? It is convenient, but is it an attractive hazard?

An associated question is this: even if basic quality were judged to be sufficient, how do RBCs integrate into the system of medical care?  Do RBCs comfortably integrate into the system of care, or do they further fragment care in an already fragmented system?  And are there unanticipated consequences that might be associated with the spread of RBCs?  For instance, by taking from practices the more acute cases which are also high-margin visits for practices, do they endanger the economic viability of primary care pediatric practices?  Finally, in envisioning the proper functioning of the health care system, the AAP and other organizations have endorsed the Patient Centered Medical Home (PCMH) as the ideal center of the system.  Is provision of care at RBC's consistent with the centrality of the PCMH?

The final question is, what is to be done?  Clearly, in some areas and for some patients, RBC's seem to be answering a perceived need for accessibility.  Should established medical organizations welcome and strengthen RBC's and work to bring them into the system?  Should established pediatric practices and clinics take on RBC's and compete?  How can the perceived need for accessibility be best met by our medical care system?

Quality of Care in RBC's

The most important current question in RBCs is: does the general quality of care for children pass the threshold where RBCs can be recommended for patients?  Despite great advances in quality measurement, this is not an easy question for any practice site.  Some aspects can be measured, especially stereotypical encounters such as immunization administration and sore throats, although even there we are dependent on accuracy of charting and subject to manipulations by savvy clinicians – that is, a clinician can easily make a diagnosis that he or she knows will call for an antibiotic if that is what they want to prescribe.  But many important aspects just cannot be measured – accuracy of diagnosis and pursuing occult diagnoses are important immeasurables, for instance – and determining an overall assessment for a practice is still well beyond us.  

Thus, determining how well RBC's actually function medically is a very difficult question.  If it were a question less important than the health of children, we could afford to wait and let experience decide.  The sometimes critical nature of health care, however, makes it important to arrive at some judgement.  Given that RBC's are very different medical entities than traditional ones, the burden of proof of safety and quality should be on the new entities themselves.  While we need to be open to innovation, safety should be the first consideration. 

In the original work on quality by Avedis Donabedian, he distinguished three levels of quality assessment: structure, process, and outcome.  In most American practice situations structure can tell us little, since virtually all practices and clinics have the requisite clinical equipment (blood pressure cuffs, basic lab equipment including rapid strep testing, etc.) and most pediatric practices and clinics have Board Certified pediatricians (or at least family practitioners) giving care, and they have what we could call medical environments, where medical standards predominate in an almost unspoken way, and where peer influence is medical.

In RBCs, however, basic structure is different.  Clinical equipment is probably up to par, but Board Certified medical personnel are not present.  In addition, RBCs operate in an environment isolated from medical personnel.  Instead, the immediate environment is retail, by definition.  Further, the RBC enterprise at large is sponsored by commercial entities that are not primarily health entities, as are hospitals or health care networks.  It is possible that this overall direction will have some effect on the RBCs.  Let us deal with those three questions now.

First, personnel.  Traditionally, medical care has been dispensed by physicians, and in the case of children, by pediatricians and sometimes by family physicians.  APNs and physicians' assistants have been introduced to the medical workplace in recent years with good results, mostly practicing in concert with physicians, and sometimes as a group independently.  It has been rare for single APNs and PA's to practice isolated by themselves.  Thus, the RBC model of APNs practicing away from close proximity to physicians, or at least other APNs, is new.

We do not know the hiring practices of RBCs.  What is the experience of the APNs they hire?  They almost never come from a pediatrics background, and family practice APNs have little training in pediatrics.  Are they experienced APNs who have practiced for years in an organized medical setting?  We know that APNs are not held to the same standards for continuous updating in pediatrics that licensed physicians and Board Certified pediatricians are held to.  We also do not know what oversight they receive – how constant and intent is oversight?

RBCs claim that the use of algorithms can ensure quality of care.  Has this been proved?  Is every encounter stereotypical, and thus falls within the purview of an algorithm?  What happens when a case does not fall there?  What are the back up arrangements for non-stereotypical and possibly serious cases, or just puzzling cases?  How quickly can an APN at an RBC contact someone more knowledgeable?  Are those connections in place for each RBC?  Who is the backup?

Primary care can be deceptive.  Everything is not “colds and sore throats.”  Who can identify a “simple illness?”  What appears to be a simple illness to a parent and a new APN might well be judged more serious by an experienced pediatrician.  Constant attention to possible problems is the stock in trade of the primary care pediatrician, and missing just one or two here and there might be acceptable in another pursuit, but not in children's health.

In short, the first and most important structural criteria for quality, personnel, is quite questionable for RBCs.

Second, medical environment.  In a medical environment, a medical ethic prevails.  Although unquantifiable, a medical ethic conditions actions of the participants.  Organizational theory tells us that the atmosphere of an organization determines much of participant behavior.  When medical personnel are placed in a non-medical organization, it would take a deep ethic for that personnel to have an ethic that prevails over the non-medical setting.  One could expect an experienced clinician with deep historical roots in the medical ethic to have his or her ethic prevail in an RBC environment.  It would be much more questionable if someone less experienced and less deeply rooted would have his or her ethic prevail in a retail outlet.  The APN in a retail outlet might be guided by algorithms, but the APN is also a person.  It is unlikely that the organizational structure offered by RBC's, where supervisory staff are not on site and are thinly spread, would be able to produce the same influence as one sees in a medical office. 

In many cases in medical practice, behaviors in a medical setting will be expected to improve with time, as the medical ethic takes effect.  Theory tells us that with time, behaviors in a retail setting would tend to bend toward the retail ethic rather than the medical ethic.  It is true that retail pharmacies have licensed pharmacists in place, and that the APNs will frequently be associated in a space close to them.  It is questionable, however, if they will be lending the same attitudinal support that a physician would in an organized practice setting.

Third, larger retail organization.  The major goal of a large retail pharmacy chain is to be profitable for their shareholders.  This is especially true in the modern era, as the associated goals of corporations to serve their community and serve the country have deteriorated.  If this is the larger goal, one would expect that providing high quality health care would be a constraint rather than a goal. 

What is the commitment to quality of care of the RBCs?  Do they have rigorous and continuous oversight of their care?  We do not know.  Since quality would be a constraint rather than a goal, we can well imagine that while profitability is continually assessed, quality of care is not.

It might be useful to consider a situation where, somehow, quality of care has become questionable in one of the RBCs.   What would be the response of the organization to that situation?  What if it proved difficult to replace the personnel?  What would be the response of the parent organization if the RBC were profitable?  Would they close the RBC?  Or would they let it continue while they looked for a replacement, or had the APN undergo retraining?

The RBC advocates contend that the quality of RBC care is high.  They point to a few studies that have shown that in stereotypical situations APN's in RBCs have performed as well as or better than pediatricians in usual practice situations.  While this might be reassuring, it is not determinative.  As mentioned above, such studies will of necessity be samplings that are record-based only, not based on actual in person assessment, nor widely based on actual situations that arise in their inevitable variety, and not based on follow up of many patients.

It is disquieting that the RBCs have offered the feedback of patients as evidence of quality.  While patient satisfaction is an important component of medical quality, “being served promptly” does not equate with “being diagnosed and treated appropriately.”  The fact that the RBCs would offer such inadequate responses casts further doubt on their motivation; these contentions smack strongly of the very commercial ethic that medicine should deplore.  Perhaps more telling are the numerous anecdotal reports of pediatricians who have had experiences with their patients being treated at RBCs.  While not up to the standards of scientific study, of course, these reports are often alarming in their deviation from good quality care. 

Because of the novelty of the setting, the burden of proof that quality is high and provision of care is safe needs to lie with the proponents and ownership of these centers.  Moreover, the assessments need to be done by disinterested parties.  Such assessments have not been offered. 

In sum, in the important question of quality of care, we have strong reservations about RBCs.

Relationship of RBC's to the System of Care

A chronic problem of the American health care system has been fragmentation.  In response to that problem, and in order to provide for a more patient-centered approach to care, the Patient Centered Medical Home was conceived.  The PCMH has become all the more important as improvements in medical care have produced ever more tests, ever more procedures, and ever more diagnoses.  There needs to be a center, and the PCMH is it.

The question is, to what extent do RBCs impede the mission of the PCMH?  And if the PCMH mission is impaired, is that balanced by a compensating gain in accessibility for the patient, or in cost for the system?

Continuity of care should reside in the PCMH.  Seeing the same practitioners has value in psychological terms and in medical terms.  Each patient is a distinct organism, and understanding the particulars of that individual can best be accomplished in a longitudinal manner.  The medical history of the patient can be important and is not available at an RBC.  Seeing a patient for an acute visit can trigger off a perception in the child's personal clinician that would not be possible in a clinician unfamiliar with the patient and the family.  Just as emergency room shopping is a well recognized feature of adult care, RBC shopping for a chronic behavioral illness can be just as possible and as dangerous in a pediatric patient.  Continuity is important.

Another systematic concern would be financial viability of the PCMH.  The PCMH has multiple functions, and financing all of them can be difficult.  In a primary care practice some of the highest profit margins are obtained in routine illness visits.  Financially, these visits are the “cream” that the RBCs are skimming off the top.  Primary care practices are usually the most precarious parts of the health care system, and RBCs can be compromising the viability of the PCMH.  On the other hand, cross-subsidizing (having acute visits subsidize some of the costs of the other PCMH services) might not be the only way for financing the PCMH.  It is difficult to think, however, that many payers will increase their payments to the PCMH for services other than acute visits in an effort to keep the PCMH viable.

On the other hand, aside from the severe quality considerations we have listed above, if RBCs can provide superior access for patients, this should be honored.  It is technically feasible for RBCs to communicate with practices so that the visits can be logged in the home record.  If they would wish to do so, practices could establish relationships with RBCs to give them backup and even real time advice.
The case for doing so, however, would be tenuous, even with acute visits.  When it comes to providing immunizations and other services, however, it is hard to think how this would ever constitute acceptable pediatric care.  Aside from the obvious impossibility of record keeping and assuring that the proper immunizations were administered, and aside from the lack of constant attention to immunization changes and standards, there is no way that an RBC could provide chronic care to children in any acceptable manner. 

There are many reasons to think that the best care can be provided for children at their PCMH, if one is available to them.  Quality of care would no doubt be best at the PCMH, and fragmentation minimized.  Special arrangements could minimize fragmentation at times if RBCs were utilized, but the net result would be far from optimal.


The cost of care at RBCs is said to be lower than at practices and clinics, although no studies have defined this exactly.  The posted prices are sometimes not indicative of final cost when tests and prescriptions are added in.  Nonetheless, if RBCs indeed lower the cost of care, this would be an important consideration.  Unfortunately, we do not know much about the effect of RBCs on the cost of care.  Because acute care is not the major source of high costs, if there were positive effects, we would expect them to be minor.  A recent study found that costs were actually higher with RBCs because they induced many visits that would under other circumstances simply be foregone. 

Even if there is no effect on the overall cost of care, the impact on individuals is still important.  If a patient can pay less for an episode of care by visiting an RBC, and if quality of care would be acceptable, that would make substituting an RBC visit for a practice visit acceptable, and something that practices and clinics would have to contend with.

The Responsibilities of RBCs

RBCs are new institutions.  They bring a new way of providing care and in so doing, violate many of the quality and systemic standards that have been accepted in medicine for a long time.  In making these changes, it is incumbent on the RBCs to ensure that their services are indeed worthwhile.  If we were not talking about children's health care, if we were talking about new toasters or televisions or music apps, then the market would be allowed to speak for itself.  But children's health is different.

The great market advocate Milton Friedman once speculated if the FAA were necessary.  Couldn't the industry be trusted to police itself, to make safety inspections of its airplanes without governmental interference?  A few plane crashes, after all, would put a company out of business.  Freedom would also allow passengers to choose a cheaper airline that they knew skimped on safety inspections to save money.  Even Milton Friedman, however, came to endorse the role of the government in prospectively ensuring safety as opposed to the market in the case of airline safety.

We would assert that children's health is more akin to airlines than to toasters.  Safety and high quality are important.  Thus, it is incumbent on the innovators, the RBCs, to prove its high quality and safety.  Studies need to be conducted by impartial parties.  The RBCs need to present their plans and operations in detail, without regard to company secrets, to convince the public and the medical profession that its operations are proper.  If they can surmount the quality problem, the RBCs need to ensure that care is only minimally fragmented.

The Need for Innovation

Despite the many negatives for RBCs sketched in this paper, it is important that medical care organization not be stuck in current arrangements.  Competition is a good thing.  It is important for current practices and clinics to understand deeply the barriers they put up between them and their patients. 

What have RBCs supplied that practices and clinics have not?  Clearly, easy availability is very important to modern families who generally have busy lives.  Have practices and clinics sufficiently adjusted to that fact?  Do they understand the need to adjust hours and appointment procedures to the families' needs?  Do they feel the urgency to adjust?

Most people respond to threats more rapidly than to suggestions.  The best results from the RBC movement would be for practices and clinics to adopt easy appointment procedures, drop-in times at early and late hours, and extended hours for both acute and routine visits, including both weekdays and weekends.  Another good result would be for more clinics and practices to understand the need to become PCMHs, in fact even if not formally accredited.  Some practices and clinics might want to compete closer to the RBC turf, and to establish RBC-like clinics close to patients but tied in directly to the personnel and EMRs of the home practice.  Many other accommodations and innovations would be possible.

It would be wrong to reject RBCs simply because they were a threat to the usual way of doing business.  It would be right, on the other hand, to reject them as they currently exist for many of the reasons stated in this position paper.

We frankly believe that the quality barriers are too high for RBCs to be viable purveyors of care to children.  Nonetheless, innovation is to be welcomed, and not to be rejected just because it is new, or just because it is uncomfortable for existing institutions.  The best response from a system is to compete, and to find a way to supply the same services that the innovators are providing, or better. 

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