Saturday, August 27, 2016

Epipen, Generics, and the Challenge to the AAP


Now everyone knows Epipen, the auto-injectable allergic anaphylaxis antidote whose manufacturer is now price-gouging patients who need it. Little Pharma (generic manufacturers, as opposed to Big Pharma, with the blockbuster brand names) has finally, perhaps, gone too far, just as Jose Canseco, Mark McGuire, and Sammy Sosa finally broke the steroid back way back when. A generic company has an old drug that was cheap for years, and instead of simply continuing to charge what it charges and make a normal profit, since it holds a monopoly on manufacturing the drug, it blithely raises the price to the rafters. Those needing the drug have no choice but to pay a lot more than they used to. The biggest difference with McGuire et al., I guess, is that Major League Baseball had the tools to enforce reform. With the federal government prostrated before pharma, the arrow in the quiver is not so apparent. A new arrow will have to be manufactured, because the government can't now price fix in a (fictional) free marketplace for medicines.

I first heard about the generic issue a few years ago when my med school roommate, now an ophthalmologist in Anchorage, told me the price of an ophthalmic generic he uses in the office had gone through the roof. Then there were articles in the media, and pediatricians on our American Academy of Pediatrics SOAPM listserve started complaining that mebendazole, a great and formerly cheap medicine for pinworms, now cost $600. Sneering Martin Shkreli then entered public consciousness by raising the price of daraprim by 6,000% or something, and even Congress had to become aware of the gap in the law. And now Mylan Pharmaceuticals, headed by Heather Bresch, the daughter of conservative West Virginia Democratic Senator Joe Manchen, says she is “just running a business,” but in the process has stepped on the snake of allergic families, who are too numerous to be ignored, by boosting an Epipen two-pack to $600, a supply that has to be renewed every year and a half, and which quite often needs to be paid directly by the patient because of their high-deductible policies. Congress is once again “Shocked! Shocked I tell you, Ricky!”

What a charade. What a charade. You are a professional organization dedicated to the health and well-being of children and their families, but you evade an issue as long as you can, do nothing, have no plan, don't give a crap, really, crocodile tears up to the knees. When the issue finally comes to a head, led by an on line petition from patients, not professionals, patients – they publish a “me, too” statement from our president that commiserates with the financial burden of patients and says not one stinking word about the general subject. No outrage, just hand-wringing.

At the AAP, they tell us don't say “they,” say “we,” “we are the AAP!” OK, I'll say “we.” We are full of crap. We knew it was going on – the listserve had it on there time after time. I suggested to our Committee on Child Health Financing that we compile a list of affected generic drugs and press this on our government. I suggested it publicly on the Listserve. At least confront Congress with the scorecard. Good luck with that.

So the Listserve erupts along with the public over Epipen. One participant points out that the issue was number four in priority in last year's ALF – the Annual Leadership Forum – where the top ten are supposed to be acted upon. Acted upon. That means, taken up as a priority. Something done about it. I said, great, an ALF resolution. Duck and cover, crouch and shelter, because here comes the earthquake of AAP intervention! Right, the Listserve commentator wrote to me privately, it's really a shame what happens to ALF resolutions.

My friend Christoph, Chairman of SOAPM, a courtly and energetic young man from North Carolina whom I like, whom I indeed urged to run for the position, forwarded the issue to another competent and amiable young man (they're all getting young to me, sigh) who heads the AAP Washington office, whom I also like. He responded:

  • we have been thoroughly engaged in working with public policy makers, the company and others to address the burdens the high cost places on families and the barriers it creates to accessing this crucial medicine.

  • we are working with Congressional staff to help them understand the issues. Since ALF, we have been pursuing an advocacy agenda, led by the AAP Committee on Drugs, and have participated in Congressional hearings as well as HHS meetings on Epi Pen and other drug pricing issues. We have also formally joined an AMA task force on pharmaceutical costs. 

  • With AAP support, one of our members ... took our concerns right to the COO and CEO of Milan (sic) earlier this summer.
  • To keep up the pressure, Dr. Dreyer is issuing a media statement today.
So I responded:
­Mark, why haven't we heard anything about this?  Why is the President's column in the AAP News always about helping the poor (not that there's anything wrong with that)?  What has the AAP been doing?  Is testimony effective?  What has it been, anyway?  Have I just been inattentive?
There is a whole list of drugs that have gone up and up and up, Schkreli-ized.   What is the AAP perception of the problem?  As someone has said, it's not what's illegal that should be stopped, but what's legal that should be stopped.  What is the AAP preferred solution?  Or at least, where is the AAP explanation of the difficulties of having a solution?
Is the AAP modus operandi to be a soft voice inside the tent, or to make common cause with parents and patients outside the tent?
Is it better for the AAP membership to be left out of the action?  It may be, that's a viable position, but it probably conflicts with the concern for membership numbers.
I have a lot of respect for our Washington people ....  I'm less secure in the AAP's traditional avoidance of public controversy in political matters, and this is a political matter, with lots of money and power on the other side (pharma), some of which spills into AAP coffers, I imagine.  That can lead to an organizational dilemma.

There are lots of questions here.  But at this stage, I think it should be embarrassing for the Academy to be upstaged by an on-line parents' group in a matter that relates directly to the health and well-being of children.

budd shenkin

More discussion followed. Christoph observed that lots went on that we won't know about but that this is appropriate, because the Listserve is available to many people who work for pharma. Some truth in that, but only some. Christoph expressed his confidence in the AAP, which I don't share. But he is congenitally trusting and I'm suspicious, a learned habit.

What kind of an organization are we (“we are the AAP”)? I think we are not a shit-kicking, obstreperous organization, which can be OK. As long as we press forward and stick to achievement. But all organizations need to guard against being a blame organization, where the chief objective of members of the organization is to avoid blame and thereby to keep one's job. There is a difference between patience and complaisance.

Mark's reply is CYA – we have fulfilled our responsibilities to the membership, here are our activities. Our theory? Dunno about that. Our endpoint? A rollback of Epipen prices for a while? That's pretty limited.

In fact, the problem with generics is generic, not particular. What do you do about the phenomenon? It's a puzzle. In a past era of corporate responsibility, corporations did not identify their actions the way the Mylan CEO does, as simply increasing shareholder value. Instead, they saw their responsibilities as extending to the welfare of their clientele, their workers, their community, their country. They identified their actions not in reference to what was legal, but to what was right. Not all of them, and not all of the time. But the feeling was expressed by Charlie Wilson, president of General Motors, when he was asked in his confirmation hearing to be Secretary of Defense in 1953, if he could make decisions as Secretary of Defense that were adverse to the interests of GM, said yes he could, but that he could not conceive of that situation “because for years I thought what was good for the country was good for General Motors and vice versa.” Or think about the relationship of Eastman Kodak to Rochester, New York. So in those days, unlike today, shareholder interest was important, but not decisive.

Not that the 50's were definitive of greatness. The auto industry declined in serving the public well, their organizations became blame organizations, and it took the Japanese for the industry to start serving the public well again, and it's not clear that Detroit ever really caught up. Industries decline – nations decline, for that matter. The point is, for decades the generic industry functioned well. When the patents on brand-named medicines terminated, generics took their place with much lower prices, the public was well served, and the new manufactures made a reasonable profit. Now, like Detroit in the 70s, the generics industry is in moral decline, driven by the nefarious Wall Street perception that the only boundary for industry action should be legality that can't be evaded, and if it can't be evaded, legal change can be bought. Epipen is just a symptom.

Every change in profit-seeking is buttressed by an ex post facto ideology. The current ideology is that of the radical free market, to an extent that Adam Smith never dreamed of. Narrow self-interest has been deified as socially responsible. “Greed is good” prevails. But this is new. In fact, as current debate on the course of capitalism illustrates, there has always been conflict between capitalism and democracy. Democracy sets the playing rules for competition so that it serves the public interest, and democracy also erects such public protections as labor laws, financial regulations, and welfare systems. (see unfortunately behind a pay wall, https://www.foreignaffairs.com/reviews/review-essay/2016-06-13/capitalism-crisis )

And because economics is never stable for long, there need to be constant readjustments. The surprise over the depth of Trump and Sanders support reveals once again how unstable capitalism is, how there are always losers, and how limits always need to be set on the winners. One need not be a Marxist to understand how the triumphs of today lead to the contradictions of tomorrow – how will we pay our populace as robots edge toward the nirvana of less and less boring work? But I digress.

The point is, if custom and moral social responsibility will not regulate a company that finds itself in possession of a monopoly product, how can we restrain the rents obtained? (that is, profit based on monopoly rather than competition and costs.) One way would be to bust up the monopolies by easing entry into the field (reform the FDA), or even subsidizing the creation of competitive entities. This would be nice, but oligopoly is not a great solution to monopoly, much as we welcome the self-regulating mechanism of competition. Oligopolists also enjoy rents. Another would be to regulate profits of the generic industry – difficult, but it could be done by clever economists. I could imagine other solutions as well, but whatever, it is crystal clear that something needs to be done.

How does this relate to the AAP? For government to act, there needs to be public pressure. As FDR said when meeting with a convincing case presented in his office (paraphrase): “You've convinced me. Now you need to go out there and make me do it.”

If you want to keep your job, you can follow procedures. You can refer an issue to the Committee on Drugs (what did they do, I wonder?). You can “meet with Congressional staff,” which means bring the issue up when you are meeting with them anyway. Etc. You can “maintain your relationships” with your counterparts in government. You can defend yourself before your constituents by citing procedures followed.

Or you can make the case and build up pressure. The NRA has no problem doing that. They educate their members on the issues at hand, they meet forcefully with representatives in Congress, they threaten vengeance on non-adherents. They aren't lovable – Wayne La Pierre is probably psychotic – but they sure are effective.

The AAP (I forgot - “We”) could make the case to our membership. What pediatrician is not enraged by these price increases, but these suddenly unavailable medicines? Instead of sending out email missives “let your Representative know!” “we” could really organize and bring it to them. We could get our task force moving in important districts. We could have a position, for God's sake – currently all we have is hand-wringing. We could have a newsletter that mentions the issue now and then, and actually elucidates the general problem so that there really is a general consciousness and understanding within the organization members.

We” could generate a sense of outrage. Here are companies that act against the general welfare under the guise of “doing business,” as thought that were clearcut. “We” could push as though we meant it. “We” could actually stand for something against the weight of pharma. Think it's dangerous to do so? David probably did also, thousands of years ago, but he seems to have done pretty well.

Google says, “Don't be evil.” The AAP could say, “Don't be pusillanimous.” In both cases, it's naming the temptation to be avoided.

Or maybe I'm all wrong. Who knows? Maybe the spontaneous patient uprising was covertly ignited by an AAP agent. Wouldn't that be a great surprise?

Budd Shenkin

Monday, August 22, 2016

ACA Loses Players in South, Rural Areas


The current headline is that the ACA is losing insurance players in the South and in rural areas: http://www.nytimes.com/2016/08/20/upshot/obamacare-options-in-many-parts-of-country-only-one-insurer-will-remain.html?utm_campaign=KHN%3A+Daily+Health+Policy+Report&utm_source=hs_email&utm_medium=email&utm_content=33221403&_hsenc=p2ANqtz--irR_Eb4J3TRTb_Sqw8o7k8-395GjpFwyrOV99xXN0TWS26sL7B1yyTTEBdA3BRcLRs9RdpHDYOxCgrcq5TCDcjcRpDQ&_hsmi=33221403&_r=0
We've all read about United and now Aetna withdrawing fully or mostly from the ACA plans.  Many variables explain this, among them the Obama decision to let some patients stay in their current plans and thus not populating the Exchange plans, plus the basic idea that the young and well would pay for the older and sicker, and also the fact that so many newly insured were too sick to be insured previously.
But lurking behind that, I think, is that the insurers have not found a good way to lower costs - although the cost increase is at a lower rate than before the ACA - and the fact that the ACA didn't provide many tools for lowering costs, as we all knew at the time.  They opted for increased coverage, a worthy goal, but insufficient in the long run.
In looking for doctors and hospitals to join their cheaper plans, the insurance companies simply asked them to take less payment, which many have refused to do, since their other books of business were large enough that they could survive without having to take in this lower paying contingent. So the result is, decreasing choice.
Hillary Clinton's resurrecting the idea of a public option, and/or Medicare for decreasing age levels (age 60, age 55) may be a stop gap, but what is really necessary is a way for costs to decrease where they are most egregiously high.  Medicare has done its part at times -- when we used to eat lunch at the doctors' table in the hospital, we'd hear the ophthalmologists' complaints that they could no longer get $2,500 per cataract, poor babies.  Then the cardiologists complained.  I would turn to my pediatric colleagues and say, "Let's commiserate with them when they get down to our level," which of course never happened.

Now Medicare is totally revamping the way they pay, targeting fee-for-service as the culprit, and substituting risk-based payments, or value-based payments. Maybe some of it will work, but probably not very well. I concur with Jonathan Oberlander's cautious attitude: http://www.nejm.org/doi/full/10.1056/NEJMp1509154#t=article

The problem is Medicare's size and consequent remove from the details of care. Yes, size gives power, just ask the ophthalmologists and cardiologists. But the larger the size the broader the strokes. The value-based payment program takes the economists' ploy one step further. The economists say, “Imagine if we had a tool that could discriminate value....” Medicare and other payers say, “We have a tool that can discriminate value.” But where is that tool? It's not obvious that they have it, sorry to say. Yes, they can determine truthfully that a certain back surgery is overused and often useless or worse, but their only response to this knowledge is to refuse to ever pay for it, thus depriving those patients who really could use that surgery from coverage that justice should afford them. And that's just one example; there are literally thousands upon thousands. And incentivizing “quality” by the by-now ancient and increasingly discredited P4P (meet certain requirements for routine quality of care) is not likely to do the trick. Increasing the distance between provider effort (actually seeing the patient) and payment is not guaranteed to make medicine smarter and more efficient.  As Donald Trump would say, "Believe me -- not guaranteed.  Believe me.)

What we really need is a marriage of Medicare's power and the knowledgeable discrimination of more decentralized organizational units. That could be local IPA organizations of doctors; that could be specialty organizations, both of which could pay more attention to nuance. There could be public spirited hospital based entities that ruthlessly dissect the monopolistic, profit-protecting hospital industry to deploy proper conditions for competition, and proper regulation of hospital practices. Ojala!

The problem with this scenario, however, is as always, money and power. Regulatory agencies are subject to industry capture. Today's Medicare Administrator is tomorrow's President and CEO of America's Health Insurance Plans, succeeded by a former official of Optum, a division of United Health Care – and that's in a Democratic administration (centrist, it's true, but still....)

Should hospitals be “the center of the system,” as they and many health policy theorists have long proclaimed? Although there are many of us who think this is a poor proposition, that's the original thesis behind the creation of Accountable Care Organizations, created by the ACA as a new organizational entity that will streamline care and reduce costs. Right, with the hospitals in charge. Yes, there are some primary care based ACOs, and they have generally proved better than the hospital-based ACOs, but try getting that to be national policy, when the current money and power is in hospitals and large medical centers. Just try to.

To recount this argument: Medicare has the power, but they need more decentralization to deploy it properly, and the agencies that pop up to be those centers of decentralization are, mirabile dictu, inevitably those with the most to lose and the most to protect. It's a challenge.

Nonetheless, we must be hopeful. Hopefulness is a moral necessity. Experience shows that setting goals is often over-ambitious, but that estimates of our own capacity are often overly pessimistic. The challenges are greater than we think, but our power to act is also greater than we think. So, I am hopeful, and always will be.

It turns out that, despite my decades long history as a practical practitioner of the art of medical organization, I am at heart an ideas man. I believe that if one can articulate the problem and the solutions properly, in the end, ideas will supply the fodder for enlightened action in a properly functioning democracy – we are not properly functioning, but we are probably good enough over time, I think. And there is never just one solution, there are simply steps taken one by one toward possible solutions. To requote Keynes: “Practical men who believe themselves to be quite exempt from any intellectual influence, are usually the slaves of some defunct economist. Madmen in authority, who hear voices in the air, are distilling their frenzy from some academic scribbler of a few years back.”  I would just substitute "policy analyst" for "economist."

So, in the short run, some areas of the country will be faced with fewer insurance choices and probably quite narrow networks of providers. In the medium run, we will have multiple levels of care. Some of the levels will have more conveniences than others; some of the levels might actually have a lower quality of care. But I would doubt that we will get to the point where wealthier people can get a lifesaving drug and less fortunate people cannot. I doubt that specialty operations and medical treatment will be denied the less fortunate. I think the ACA will always be seen as a positive step toward more equity of care, and over time the levels will converge, although never completely.

In the meanwhile, I don't see any substitute for continuing effort and vigilance by well-intentioned people – generally described as those who agree with me – in examining conditions and proposing improvements. The great virtue of the ACA was breaking the logjam that was health care policy. Now that we see the logs flowing down the river, bumping into each other and crashing into the river banks, it is our job to prod them into a coherent whole that promises stiller water and streamlined flow ahead.

As we say, “Ojala!”

Budd Shenkin


Thursday, August 4, 2016

How Marcus Welby Can We Be?


I was already a doctor when Marcus Welby, M.D., came onto TV screens.  It wasn't something I would watch. I was busy, it was network TV, it was sappy, it was suburban WASPy Republican without the Beav's charm, and he was a general practitioner (who amazingly seemed to have one patient a week). Even though my grandfather had been a general practitioner before he died of a brain abscess in 1933, my Dad was a neurosurgeon, so in our family specialty trumped general practice. My Dad's distrust of other doctors, like GP's, was such that he said each generation of a family needed at least one doctor, to protect them from the shit that is out there. So for his generation, he was it.
(Many will remember neurosurgeon Ben Casey, which was nearer and dearer to my father's heart.  He enjoyed the lionizing of his specialty, his face lighting up with reflected glory. I think he watched it. I didn't; I was busy in college and med school and didn't have a TV.)
So, my Dad organized our care, either dispensing it himself, or choosing the doctors personally and carefully. When I broke my leg sliding home on an ill-conceived steal attempt, he took me to the hospital and his friend Chuck Kambe operated. When my Mom needed back surgery (twice), my Dad did it personally, saying there was no reason his patients should get better care than his wife. If we were sick he might call in his GP friend Dave Cohen to help, after Dad checked our Babinski reflex to make sure we were neurologically intact (first things first), and Dave gave us our shots, but Dad never really gave up the reins. When I went to a Harvard recommended dermatologist for a skin lesion that wouldn't heal and the dermatologist failed to help me, Dad sat me down with the Medical Letter and we treated it successfully with griseofulvin. I went with him once on a consultation to a community hospital ER, and I said afterwards, didn't the patient really need a neurologist rather than a neurosurgeon? My Dad growled his answer: “What that patient needed was a smart doctor.” QED.
Then I became a pediatrician. Not easily. When my Dad told his colleagues at the hospital lunch table that I had decided to go into pediatrics, they said, “Henry! Those guys work their tails off and they don't make any money! ...Can you talk to him?” They knew where their bread was buttered, for sure.
It took me a long time to become a good pediatrician. I had graduated from a specialty program that had little primary care – actually, nearly all residencies are specialty programs, and the outpatient clinics are models of poor organization – so I didn't know much about practicing, but some of what my Dad taught me probably stuck. I didn't realize it at the time, but my learning to practice took me, inevitably, to the importance of caring for each individual person. I found out that what people wanted was, predictably, Marcus Welby.
They wanted someone who cared for them (preferably only them), someone who was competent, caring, and reliable. And accessible, very accessible. The caring came naturally to me. The rest I had to work on. Thankfully, I had a gift for organization, so the practice became a success.
Marcus Welby functioned well, however, only in the idealized atmosphere of TV and the time when we had so many fewer tools, and so many fewer specialists than we have today. He saw some patients in the hospital, called a specialist at times and dropped into Xray to read the films, I guess, and I think I remember that he showed up at odd times at the family's house. My Dad would approve of that – he said that trust in doctors eroded as soon as doctors no longer shared a cup of coffee at the patient's kitchen table.
Well, those days have been put to rest by the plethora of tests and treatments and specialty care. Modern medicine can do so much more for patients than old-fashioned medicine, that a single doctor can't keep it all in his or her head. There is too much to do to be tooling around town, showing up and kibbitzing. Patients might still want Marcus, and doctors might still want to be his disciples, but to meet these expectations, care has to be organized in a new way.
The question is, how do you do it? How do you organize your practice so that you get Welby-like results in the modern environment, trust and intimacy linked to modern science?
I have to hand it to my fellow pediatricians. I've talked about our American Academy of Pediatrics listserve for the Section on Administration and Practice Management (SOAPM). If my Dad could have seen what goes on on the listserve, how my primary care pediatrician colleagues struggle to do the best possible, to think everything through, he would have been gratified and amazed. So, to illustrate the point I'm making, here are two recent exchanges 0n the listserve about how we are facing the dilemmas of practice.
First, Kerry Fierstein of Long Island:
This weekend, I had one dad call at 10 PM Saturday night needing a camp form filled out before 9AM when they were driving to soccer camp, and at 12:30 AM another dad called for a Lialda Rx because teenage son with UC ran out and they were leaving on a cruise at 7 AM and GI didn't have an emergency number.” These are extreme patient demands, but Kerry accommodated them! Amazing, to me. Part of her thinking apparently was that, as a Patient Centered Medical Home, her practice needs to honor patient needs as much as possible. More on the PCMH below.
Second, from Ashraf Affan of Jacksonville: “Can any one recommend a good pediatric call center that can handle calls during the day to schedule visits, etc, for a fairly large private practice. We are trying to weigh outsourcing the job vs. housing in.” He received many answers from the group, most replying that you have to do it yourself in your practice.
Michael Sachs of Los Angeles told of his experience: "We're about to (reluctantly) go to an auto-attendant and voicemail during office hours for the first time ever. It was either that or hire more people to answer incoming calls, but we don't have the physical space and would prefer not to pay one or two additional salaries. … We're not big enough to use a scheduling center or outsource, but having been on the patient end of scheduling a visit for one of my kids at a local major medical center, it was a time consuming PITA. First talk to an intake person and be told that a nurse would look over the information. Then receive a phone call back a day or two later with the great news that a nurse has approved the visit.....and the same scheduling person I'd spoken to the first time now wanting to know when I'd like the appointment. 'OK, I'll see if that's available and will call you back' Couple of days later, a call back with more great news - that time is available! Now the appointment is scheduled. A few days before the appointment, the same person calls back again to confirm the appointment time. But he doesn't have the appointment time, he asks me when I show the appointment is scheduled. Tell him, he puts me on hold for a few minutes, then returns and confirms that it's the same day and time he shows in his system. Now I'm getting a bit concerned since it seemed that he didn't know WTF he was doing so I called directly, spoke to a receptionist in the physical office, and she confirmed that the day and time were correct. Whew, that was a relief. Total time scheduling and confirming the appointment: at least 30 minutes.”
Suzanne Berman of Crossville, Tennessee offered another alternative: “We have a 'call center' model (although our call center is physically located in our office) staffed with 4 nurses and 1 one receptionist/non-nurse. Going to this model cost us a lot in the beginning, because nurses make 30-40% more/hour than receptionists (on average, YMMV). BUT we found that the nurses could do triage AND scheduling ('yes, that belly pain needs to come right in; no, your bug bite is not a 5:30 PM emergency'). They could also more holistically look at the whole chart and the whole family. Like, they're making an appointment for sib A and they say, 'Hey, I notice Sib B needs a checkup. Are you bringing him with you? OK - wanna do his checkup?"'

This improved our recall/compliance an awful lot. In short, we found it was more cost effective to have nurses evaluate the possibility of 'super-sizing' the visit on the front end (when the patient was pretty much already committed to coming into the office anyway) than using lesser-paid receptionists trying to do recalls post hoc on overdue patients. (I mean, we DO do recalls too, but it's a lot easier to get them in in the first model.)”
First, Kerry's situation and her heroic efforts to accommodate her patients. I think you can look at this as a spectrum of how we balance patient convenience with doctor convenience. Way on the left side of the spectrum is the old model clinic where my father used to work at Philadelphia General Hospital a half-day a week, where care was free and the doctors unpaid, when it was an honor to be chosen to work there, and where appointments were probably given at 8 AM for every patient who was to be seen that morning. The care would be excellent, but the amenities not so much.
Way on the right side is Marcus Welby when that was feasible, and in the present day, almost to the end of the right side of the spectrum (but not quite), is the Patient Centered Medical Home (PCMH). A PCMH centralizes all care for the patient, keeps all records, not only makes referrals but helps the patient make the appointments and follows up by telephone to make sure the referral was completed, teaches patients how to care for themselves, etc. To do this, the PCMH employs non-physicians to help and practices what we call team care. It's the center for the patient, it's the place they get treated like they are at home.
Even farther to the right, however, way out there for the modern equivalent of Welby-care, is concierge care. In this model a practice cuts way down on the number of patients it serves. Given the extra time thus available, the concierge practice does all the PCMH does, and in addition offers exquisite availability of the same doctor nearly every time on the same day you call, extended time for consultations, extended counseling and coordination services, and great concessions to patient convenience, like call to the doctor personally 24/7. I've probably left out other important services. Examples of concierge care that would not be expected in a PCMH would be: meeting the patient in a parking lot or on a sports field for patient convenience; sending a patient to two or three different allergists for consultations, speaking personally to each of them, and then meeting with the family to come up with an allergic plan; giving the patients a traveling kit of common medicines, including antibiotics, so they don't have to go to a pharmacy. This is Welby-plus care in the modern age.
Of course, PCMH and concierge care cost more. In addition to the normal fee-for-service payments, PCMH care requires a yearly fee, and/or per-patient-per-month capitation fees, or fee-for-service payments at a higher level. Concierge care requires even higher, paid in advance fees – sometimes, the payment is unbelievably high, from what I've heard. In contrast to the PCMH model, the concierge model actually decreases staff overhead, since fewer patients are served and the operation is thus simpler. It's an interesting model, although clearly not for every doctor, and not for every patient. Office automation lies behind both models – you can't do all this on paper. Automation actually enables decentralization, and in these cases, enables more Welby-like care with modern medicine modalities.
So, the dilemma is faced: how do you operate like Marcus Welby in a modern context, and these are the answers. It takes work, but in the end it looks to be very possible. It costs more, but since most medical costs center on the hospital, the extra cost for high intensity primary care is probably budget dust.
Second, Ashraf, Mike, and Suzanne's case of how to handle the phones. Once again, I would apply the “poverty clinic to the left, concierge to the right” spectrum. Clearly, at least to me, the medium is the message. Phone tree or outsourced call center, and you are moving left, where doctor convenience trumps patient comfort. Talk to a person, have that person kind and focused on you and taking time with you, and you are moving right toward Marcus. But note Mike Sach's experience in making an appointment himself with a hospital-based practice – it's a corporation! Corporations – and hospitals are very much corporations -- feel they have to centralize, they have to be impersonal, they have to impose their will on you for their own good and their own convenience. The doctors can be fine, once you get in, but with corporations in charge, the feeling often gets to be that it is you the patient along with the doctor fighting corporate practices and policies! So far, they just don't know any better.
So, here it is in some of its details, the modern dilemma of organizing primary care. Will it go corporate? The thumb on the scales is in favor of the corporations, who get more money per patient by their superior insurance contracts. Or will the smaller, more personal, more Welby-like practices, empowered by personalizing automation, survive and prosper? Or will the corporations change their spots and learn to incorporate personal care in a personal way? (The keys here will be, I think, one, how competition can be organized to work in favor of patients' needs and desires, and the needs and better-angels desires of doctors, and how doctors can muster the skills of leadership and organizational change – but more of that later.)
Modern medicine is great; we can do so much more than my Dad's generation, and each year is better than the year before. But even if we can't share a cup of coffee at the kitchen table, and even if we can't pop up at the patient's house at odd hours, we can preserve the personal relationship that is the key to medical practice, as I learned, and be competent, caring, and reliable – and non-bureaucratic. It's just a question of organization, and of competition that spurs better organization and better, more personal care.
Budd Shenkin


Saturday, July 16, 2016

The Wisdom of Thornton Wilder


When I was in 7th grade, I think it was, my whole family — Mom and Dad, Bobby, Kathy, and Emily — trooped out to the Friends’ Central School Senior Play to see me say my one line as Wally Webb in Thornton Wilder’s Our Town. “Aw, Mom, by 10 o’clock I have to know all about Canada,” quoth me as Wally. Then I trooped off the stage to school with a senior playing George Gibbs as he tried to ingratiate himself to me as a route to my sister Emily Webb’s heart. It was a spare production, as Our Town productions generally are, since the part of God is taken by the Stage Director who speaks directly to the audience, so it’s a play within a play, and since the Stage Director has to move sets easily with the audience watching, they are minimalist.

I was only 13 or 14, I guess, but I got that part about God, even if not using that word. When my sister Emily Webb asks the Stage Director if she can go back in time and see her family and herself as it was years ago, before she died, he can do that for her, even though he advises against it. He could have said “You Can’t Go Home Again,” but that Thomas Wolfe book was actually published two years after the 1938 first production of Our Town, so he didn’t. But going home again must have been in the air then, or maybe it always is.

Wilder’s Grover’s Corner was pretty far away from Philadelphia’s Main Line where our performance took place, but it didn’t seem that far away to me. Traveling to the Main Line was already a stretch from West Philadelphia, where we lived not far from the Penn campus on 47th street, around the corner from our friends the Levin’s, the Egnal’s and the Kagan’s, all Jews like us, first and second generation after the great Eastern Europe Jewish migration of the 1890’s, all professional families, and all determined that their children would have full educations and full opportunities in life. That was what our ancestors had gifted us with, and the sense of mission hung heavy in the air even though usually just implicit.

We were assimilated, as my mother explained to us. We loved Philadelphia, we loved baseball and basketball and football, the A’s and the Phillies and the Warriors and the Eagles; but we also knew we weren’t from here originally; we knew our history as filtered, in our case, directly from our parents, since my mother didn’t like her parents very much, and my father didn’t like his mother very much and his father had died when my Dad was 17. We heard about ancestors from time to time, and my mother had two wonderful childless aunts whom we were close to, and years later we would see the pictures of the larger family that came over, with beards and European clothes, with some Jewish first names, but nothing religious, since my family didn’t believe in religion. We knew my father’s maternal family were bankers wiped out in the depression, and my father’s father was a doctor and Philadelphia champion pool player, harried no doubt my his wife, who was that sort of person. My mother’s family was in retail, and my aunts looked back at the 20’s with wistfulness, the way we look back at the 60’s and 70’s. So we had a sense of where we were from.

Ambitious but frugal, insecure but confident in abilities, and willing to defer gratification – in short, we fulfilled the Tiger Mom formula for “success.” We got to Friends’ Central when my Henry C. Lea Elementary School 4th grade teacher, Miss Ousey (“Lousy Ousey”), committed the cardinal sin of having a low bar by telling my parents enthusiastically that I “was definitely college material.” “'College material', really?” As ambition trumped frugality (and a Commie past), they found that the liberal Quakers of Friends’ Central welcomed Jews, so off we went just over City Line Avenue, into suburbia-land, just barely outside of Wilt Chamberlain-Overbrook High School land. (Nowadays Friends’ Central isn’t the only welcoming school — Episcopal Academy advertises in the Jewish Exponent. Progress!)

When I got to 7th grade the Friends' Central curriculum included a course in public speaking – one of the good ideas that has probably been dropped as education spirals downward. The teacher, Mr. Richard “Dick” Burgess, was a tall, thin man with close-cropped hair and a bow tie, who held himself quite erect, and who had a way of speaking that had him constantly overcoming a tendency to swallow his words – thus qualifying him to be the public speaking and drama teacher. He smiled easily even as he seemed to fight a tendency to swallow his smile. His sunny disposition always won, and he exuded enthusiasm and warmth even through his introversion. In short, he was endearing, the best sort of private school teacher.

His public speaking course presented scenarios where someone would commonly be called upon to speak publicly. My opportunity came as MC for a class variety show. When I displayed flair, enthusiasm, and wit, Mr. Burgess had a find! Full of suppressed enthusiasm, he dropped down on a knee – he was indeed very tall – and asked me hopefully and expectantly if I would like to be in the senior class play, Our Town, playing Wally Webb. Seeing his enthusiasm I really didn’t have to think at all, I just said yes. He told me about the weekend rehearsals, and I said yes. Who could say anything else to Mr. Burgess? Maybe I was a little scared, but I knew my family would back me, and I always said yes to dares.

My mother was thrilled and loved Mr. Burgess, and for weeks she drove me out for day-long Saturday rehearsals. I hung around with the stagehands, ate my bag lunch, generally gaped at everything, and was kind of adopted by the cast. I still remember how I could hardly believe how they adopted me and instructed me, especially since my own 7th grade class had a distinct anti-Semitic tinge. One burly guy was a stagehand, and showed me how to carry heavy items by standing tall and straight. As an eldest son, being adopted and nurtured by someone older but of my generation was very new.

When the time came for actual performance, my whole family trooped out with enthusiasm and expectation for opening night and my one line. I remember my mother telling a friend, thrilled but embarrassed by her enthusiasm, “We all went out for Buddy’s one line!”

But my one line was only something to be nervous about and get over with. What I remember more was when I was quiet. The Stage Manager, a senior named Bruce Beckwith, held his clipboard as he addressed the audience directly, and I sat on the stage on a folding chair with others in the “cemetery” next to my sister Emily Webb. My appendix had ruptured on a Boy Scout hike, I think.

I remember Emily, who had recently died, asking the Stage Manager, can’t you ever go back? The Stage Manager says, yes you can, you can go back, but I don’t recommend it. Emily says, but I want to go back! I want to see Mama! Don’t do it, says Bruce the Stage Manager, I recommend that you don’t do it. But if you want to, you can. Emily says, yes, I want to do it.

So she does. The Stage Manager takes her back to a typical day in the past, the least significant day possible, with Mama getting breakfast ready for the family, saying the typical things that she said, get ready, come on now Emily, it’s time for school. And the dead Emily calls out, Oh, Mother, you’re so young! Look mother, here I am, can you see me, let me tell you what happened!

But Mama can’t hear her, and Emily is overcome by emotion, and cries, and after a while goes back to being dead, and tells the Stage Manager he was right, it’s best not to go back. I sat there on stage and watched. I saw how they felt, but it was hard to understand. I was in seventh grade, after all. But I remembered.

Now I’m far older than Mama was when Emily went back. Not only am I older, the world is older, too. When the Berkeley-born Wilder wrote that wonderful play in 1938, technology was just getting started. Recapturing the past had progressed some, but it was still pretty impersonal. Recapturing had started with the most incidental reminders of all, fossils, then actual manmade paintings on cave walls, then memorized sagas, and mummies, and temples and statues meant to last and show to all, then words in copied books and printed books, then onto photographs, recordings, and movies. So Wilder did have at his disposal many technologies that recaptured the past, and they must have been wondrous to him, because he was obviously so conscious of time, not only in Our Town, but in Back to Methuselah — what could be more about time than that?

My father, too, had a sense of time and events. He used an eight millimeter home movie camera to record our family, and so did my Mom, my grandparents and great-aunts walking down steps and smiling one after the other, my father throwing me up in the air and catching me, my mother walking to the beach in Beach Haven and smoking, Play Day at the Henry C. Lea School where I got lost in the kindergartener’s dance, and even one of me playing basketball on a dirt court at camp, missing an easy shot off the left backboard, not quite high enough.

Eight mm was pretty personal, but now, some 60 years on from the Friends’ Central Our Town performance, we have the most personal of all the time-cheating reminders of all, we have videos, with full voice, with a long enough time frame that people don’t have to hurry, you can just be yourself for a few hours and be totally recorded. Videos of everyday life as it really is.

Photography was my hobby as a kid, and imitating my father, I guess, I filmed videos early. When I visited Philadelphia I would even rent a video camera, leaving the clunky early models I had at home. In 1986, 1987, and 1988 I took my parents, who were then about 70 and very vigorous, and we drove around Philadelphia together to where they had lived, and where we had lived. As we drove around in the car I interviewed them as they added comments to each other and contradicted each other and did what they usually did, and I also sat them down in their home in Society Hill in central city Philadelphia and interviewed them about their lives. My father had an allegiance to truth and significance, and he started talking about how he had a case, a family member of a friend, who needed a spinal disk operation which my father performed, but his resident had bad acne and probably contaminated the field, and the patient got infected, and my mother said “Don’t talk about it, Henry!” but he did, and he said, “It took him so long to die.” Being a neurosurgeon is still very hard, but it was harder then, I think. I have it on tape.

So, I have lots of tapes of our lives. The day we told the four older kids that Ann was pregnant with an embryo who would become Peter. The kids washing the dishes as their chore, that extended for a very, very long time at the sink. Lots of things. The old eight mm movies of my parents transferred to DVD format. And the interviews with my parents.

So I sent all the DVD’s out to all the kids, and I sent the videos of my parents' interviews out to Bobby, Kathy and Emily. I haven’t heard much from them. Bobby said it was hard to watch, that he started to cry and so he stopped, I think he said. Kathy said, God, what was the big deal with Mom and Dad talking about how to get to where they wanted to go in the car, what was that all about? But she hadn't gotten around to watching them much. Emily said she already had a copy of the 1987 interview and kind of brushed it off. Actually, I don't think I even got thank you's from the girls. But I take that not as a lack of gratitude, but resistance. This is hard stuff.

Me? I think it’s hard to watch. I watched all three of them, but I had to get ready and set the time aside, and be at at my desk doing something else while they were playing on the TV at my left side, so I could tune out or tune in, although in truth I tended not to do much else while I was watching, I just had other stuff available. I get so sad for the world that no longer is. Love, sadness, and feeling the depredations of Time’s Arrow. Nothing stops time, We exist in the memories of others and then not even that. We love and lose, no evading that. You really, really can’t go home again. If you’re strong, you can go back now, and I did. But it’s also defensible to listen to the Stage Manager.

Budd Shenkin

Wednesday, July 6, 2016

More Advice For Hillary


Where would Hillary be without my advice? Talk about priceless, that's what my advice is, totally without cost to her, and probably to me even if I err, despite the fact that I have tens of readers (actually, my best post has over 1,000 page views, but mostly they vary and a good one gets 100+ page views. My Hillary page views, perhaps not so much.)

So, today, three points.

The Server and the Emails

She's in a pickle. Comey really skewered her, and she deserves it. She shouldn't have done it, and then she shouldn't have attempted the equivalent of a coverup, saying it was “convenient,” etc. It's obvious she wanted to hide stuff – and given the way she has been attacked in the past, that is certainly understandable. But, still, she did something she shouldn't have done, Clinton-style, and then lied, Clinton-style.

I think I'm an outlier, but I look for chances to admit I was wrong and to be humble. I think, so should she, and this is the perfect opportunity. If she does that, she gives people the chance to be empathetic, and to view her as human. If she is always defensive and I was right and I have a plan and I will be your champion, well, who can be empathetic? So, my advice is, take the heat and do a real mea culpa – although, truthfully, could she do this? But, if she could – she is enormously self-disciplined, except when she isn't (I suspect her lack of discipline comes from her melding with Bill, the Southerner, who allows himself a lot, the way Southern scamps do) – she should say,

It was a stupid thing to do. Even smart people do stupid things, and that applies to me. I wish it weren't so. Human beings make mistakes, and that includes me. Being human is an exercise in being humbled. I'm so sorry I did this stupid thing.

I wish I could say I'll never do anything stupid again, but we all know that's not true. I did learn from this, however. I won't do something stupid like this again. The next stupid thing I do will be completely different. (OK, she shouldn't say that, but I couldn't resist.)

But, when you do a stupid thing, you really should learn from it. Here is one thing I learned from this episode. I did this on my own, and I didn't have anyone to say, 'Don't do that, it's stupid.' If I am elected President, I pledge this: I will not be a Lone Ranger. I will work with a team, and make sure that the people I work with are smart and well-informed, and also that they are not afraid to speak up and challenge me. It will be up to me to make sure I have strong, independent voices around me, and I will do that. I'm going to involve a lot of people I appoint, and I'm going to involve people in the Congress – even Republicans. I'm going to make sure that when we take steps, that as many people as possible are on board with it. Because nobody has a monopoly on intelligence and judgement.”

I figure that's the best she can do. Mea culpa, eat humble pie, make a pledge. Be human and not defensive. Let the Republicans rail against her, and sympathy will be on her side. Give herself a chance to be human. Then let it die down prior to the convention.

Vice President

So, that's the emails. That's defense. Now to offense, to the convention. Hillary needs to create some excitement. Just because she's a woman, that's not enough. She needs some pizzazz, and she needs it from somewhere else. Not Bill, please! He's past his sell-by date. So, do what?

I think she needs to bring on Elizabeth Warren as her VP running mate.

I didn't think it was a good idea before now. I thought it would be unbalanced, somehow, too out there. But now that I've seen them together, I think that's who it needs to be. Balance, schmalance. Her husband Bill didn't go for balance, he went for fellow young Southerner Gore. They were a great electoral team! Young, dynamic, exciting, not paying off this one or that one or getting this state or that state, no John Sparkman to offset Adlai, not at all. I think she needs to double down. EW is great on the stump, and Hillary can be the sage and experienced part of the team, the one who knows well how things work. And EW can not only bedevil Trump, she can excite the young and the jaded for turnout, and I don't think she will overshadow Hillary, because she will know and respect her place. No Sarah Palining for her.

They say that there are July, November, and January VP selections – to get the nomination, to get the election, and to govern. That's what they say. My wife Ann worries that they wouldn't get along for the January part of the deal. She might be right, but I think there's a chance that they would. EW is fiery, but she's very smart and mature, and I don't think she will threaten Hillary. The potential pothole for EW, and for any VP who would want to be included in governing, is Bill. After all, the biggest trouble Gore had with governing was Hillary, who kept edging him out. Would Bill do the same thing?

He would try. He would certainly try, entitled as he feels he is – and he does have some entitlement legitimately, he is a former President. I can see him edging in, or barging in, or fighting his way in, completely ruining things for Hillary. The Big Dog comes back. I can see it. I can see him undermining EW, or any VP who wants to do something in governing. That's the big unknown. That's something EW would have to have assurances about before saying yes. But for sure, I think EW would be a great November VP selection. Pizzazz! And a show of confidence from Hillary, that she will follow through on her promise to be open to strong people in her innermost circles.

A few months ago I speculated on what the December meeting between Hillary and EW was about. http://buddshenkin.blogspot.com/2016/01/between-elizabeth-and-hillary.html. We still don't know what went on there. I doubt very much it was VP talk. But EW sure has played her cards well. Myself, I'd put her right on the ticket and tell the Big Dog to stay a vegan – no eating meat, Big Dog.

Good luck with that.... But it's what Hillary needs to do.

Running with a Message

Hillary is about substance, Trump is about appearance. Hillary needs pizzazz, but she needs a program. She has a lot of programs, but she needs a Program. Put America To Work would be a good one. She actually has taken my advice, I notice! Over a year ago, I suggested that she concentrate on infrastructure. http://buddshenkin.blogspot.com/2015/05/more-advice-for-hillary.html. It's a winning argument. Now columnist Carl Leubsdorf reports that in responding to questions on her priorities, her first was: “In my first 100 days, I will work with both parties to pass a comprehensive plan to create the next generation of good-paying jobs. The heart of my plan (Hillary, would you stop saying 'my plan' please? It's a 'me' statement, not an 'us' statement, and it's bureaucratic. Say “We should thus and so.” Tin ear.) will be the biggest investment in American infrastructure in decades.”

Good! Build on this. Push the details, push the vision, emphasize how well this is thought through. This is your strength. Add all the other good stuff that is coming out, taking stuff from Bernie, etc. That's great. All of it will show off how smart you are, how you can govern, where you want to go. But “infrastructure” has a lot going for it, I'd say. It sounds so workmanlike.

And it can be in speeches, not in emails, thank God.

Budd Shenkin

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.

Costs

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.