Retail Clinics for Chronic Conditions Like Asthma, Hypertension, Lipids and Diabetes Mellitus: A Look At the Value Proposition

Is there a business model in there?

To the delight of skeptics, pundits and bloggers everywhere, U.S. health reform continues to follow its predicted trajectory: fiscal shortfalls are now biting the nominally "wealthy," the Feds aren't about to admit that they're in over their head on implementing their health insurance exchanges, opportunities for cronyism are increasing and the DMCB spouse is wondering why her supposedly expert-husband can't find health insurance for less than a thousand a month.

In the meantime, there's no sign that Washington DC will ease up on the "accomodative" money-printing presses that are feeding "QE Infinity."  That's no problem, though, because Europe is reminding us that once the paper currency is undermined, selling gold is a handy way to quell grumpy voters and prop up the welfare state.

Yet, Clayton Christensen tells us a fix is at hand: much of health care's quality and costs travails, he says, can be solved by embracing the disruptive innovation of non-physician treatment of acute and chronic conditions.  His supporters are undoubtedly cheering Walgreens' recent decision to to have its 330 Take Care Clinics add hypertension, diabetes, high cholesterol and asthma care to its portfolio of nurse practitioner services.

After reading the usual retail clinic policy tomes both for ("access to care") and against ("health care balkanization" plus "missed diagnoses"), the Disease Management Care Blog isn't convinced that Walgreens' decision is such a slam dunk.

That's because these clinics' business proposition is less about innovation and more about being a loss leader that increases retail pharmacy foot-traffic. In fact, offering free retail clinic services has been tried. The premise is that the retail customer-patients will stop by the pharmacy window for new drugs and, while they're at it, renew those other high margin prescriptions.  If they pick up some diapers and nail polish while making their way to the front of the store, all the better.

While that certainly sounds good, retail clinics are not a build-it-and-they-will-come cash machine.  Recall that CVS had to pull the plug on its retail clinics several years ago.  Foot traffic didn't materialize and the supposed loss leader turned into a money pit. 

The good news for Walgreens is that they have Jeffrey Kang in their corner.  Prior to this, he led health insurer CIGNA's disease management initiatives. He undoubtedly understands retail, population-based outcomes and care coordination. If anyone can pull this off, he can.

The DMCB's conclusions?

It won't be easy. While Walgreens' we-accept-all-insurance plans-VISA-Mastercard-and-American Express foray into primary care might work, it could also fail. Large health care systems use their primary care providers to feed their high margin and still-profitable specialty care services.  On the other side, small physician-owned practices are learning that hustling, high service standards, attention to overhead, accurate billing, patient mix and ancillaries can be profitable. Walgreens has neither. It remains to be seen whether this publicly owned company's bottom line will be aided by salaried NPs chasing pharmaceuticals' narrowing margins.

Speaking of margins, the DMCB wonders if Walgreens will use its clinics to steer patients toward favored formularies or aid rebate and market share agreements. Could they also use and eventually monetize the Big Data like Target to further the company's business interests? If any one knows, please contact the DMCB.

Commoditization?  The DMCB thinks so and it's not alone. Over time, the professionals staffing these clinics may find primary care is more complex and that they and their patients deserve better.

Ease of Exit? For who? Given that this is ultimately a business, it would be corporate malfeasance if Walgreens didn't have an exit strategy. Unfortunately, one company's exit could be another patient's abandonment. That's a real risk for the patients who come to count on Walgreens for their longitudinal care.

Patient Centered Medical Home Threat... or Friend?  The DMCB doesn't think so. If the medical home offers the value that its advocates say, savvy health care consumers will be able to vote with their feet. If the PCMH falters, it won't be because of Walgreens; in fact, the threat of competition may force help medical homes be more efficient.  In the meantime, medical homes should treat retail clinics like a community resource and refer (or outsource) appropriate patients for routine health care. Why not?

Bring On The Coupons!

Most persons with insurance that includes a pharmacy benefit are probably very familiar with co-pays.  Those out-of-pocket expenses not only reduce the insurers' costs, but are a powerful tool that can incentivize the choice of a month's supply of an otherwise equivalent generic (for $5) versus an expensive brand medicine (for $30).

But suppose the brand drug manufacturer fights back with a $30 coupon?

That's the topic of this JAMA paper by David Grande. While the coupons could be prohibited as "kickbacks," can be suddenly stopped and are often given on-line in exchange for otherwise private patient information, the main argument against them is that they substantially increase insurer costs.  As a result, Dr. Grande recommends that physicians resist the allure of giving their patients any coupons and that pharmaceutical companies find other ways to reduce patients' out of pocket costs.

The DMCB has another idea that is going unmentioned by JAMA.  Why not suggest that insurers compete should against the manufacturers' coupons with their own coupons?  Competition may eat into the insurers' bottom lines but the patients will win.

Patient interests: That's the point, right?

Free Drugs For Heart Attack Patients: The Analysis Behind the Analysis of the MI-FREEE Trial

Assuming drugs are not free, should all patients in an insurance plan that covers medications get the same coverage at the same price?

While that may seem to be a no-brainer, there's plenty of research (for example) that demonstrates that out-of-pocket costs can reduce persons' willingness to take their pills as prescribed.  While that may be the price of doing business, why not give persons who really need a particular life-saving medication a price break?  While that may seem unfair, suppose everyone in the risk pool benefits from lower health care costs?

Enter the Post-Myocardial Infarction Free Rx Event and Economic Evaluation (MI FREEE) trial. 

Too long to read at one sitting you say?  The Disease Management Care Blog at your service!

The study involved Aetna beneficiaries who had just been discharged from a hospital following a heart attack.  While the trial was randomized and prospective, the randomization occurred at the level of the insurance plan. Various employer, union, local government or other association groups (and their patients) were randomized to one of two arms:

1) an intervention group where patients had no out of pocket cost sharing or co-pays for brands or generics in four classes of drugs that have been shown (go to page e227) to reduce the risk of death after a heart attack: 1) statins, 2) beta blockers, 3) ACE inhibitors and 4) ARBs, or

2) the usual co-pay for statins, beta blockers, ACEs and ARBs.

2845 persons were placed in the "no-cost" arm of the study and 3010 were in the "usual cost" arm of the study.  The mean age was 53 years and 75% were men.  About 34% and 27% of both groups had diabetes and heart failure, respectively.  Over time, the percent of persons that were fully compliant with their medications became different: 31% in the usual cost vs. 41% in the no-cost group.  The median duration of follow-up was 394 days.

And what happened?  When the number of first-time fatal and nonfatal cardiovascular events were grouped in and counted with heart surgeries (that included angioplasties, stenting or open bypass), there was no statistical difference between the two study arms: 18.8 events per 100 person-years "usual cost" vs. 17.6 per 100 person-years in the "no-cost" group.  There was no difference in the cardiovascular death rate either: 2.0 vs. 1.7 deaths per 100 person years.

However, there was some good news.  The combined endpoint similarity was largely driven by a high equal number of heart procedures in both groups (which seemed to involve more than 10% of the entire study cohort).  If the surgery patients are backed out, there were fewer first time fatal or non-fatal vascular events and strokes in the "no-cost" group. 

There is even more good news. Some patients had more than one event (a patient could have a heart attack, a stroke and then open heart surgery, for example). When the total number of events was added up, there was a difference and it was statistically significant: 329 per 100 person-years in the "no-cost" group vs. 406 per 100 person years in the "usual cost" (p=.03).

Did the insurers save any money?  Yes and no.  Average total spending in the "no-cost" group tallied up to $18,254, while the "usual cost" group averaged $20,238.  While that's a $2000 difference per patient, it failed to achieve statistical significance. However, when the DMCB multiplies those savings by the number of persons in the no-cost treatment arm, it calculates $5,690,000 in total savings. That sure sounds financially significant. 

DMCB criticisms:

1.  Heart procedures - which may be prone to factors other than clinical need - may have diluted the results in this trial, especially if a significant proportion of them were not evidence-based.

2.  The secondary prevention benefit of drugs for heart attack patients extends beyond 394 days.  If this study had gone longer, the difference may have expanded over time and achieved statistical significance.

3.  While a cost difference of $2000 did not reach statistical significance, that may have been because insurance claims follow a non-Gaussian distribution, making their analysis very tricky.  In addition, the DMCB thinks that a real world savings potentially exceeding $5 million is very noteworthy.

DMCB questions:

1. It'd be nice to know if patients with a higher burden of disease (for example heart failure or diabetes) and therefore more vulnerable benefited more than persons with less disease burden.  If so, would it make sense to limit the "no-cost" option to heart attack patients at the highest level of risk? 

2. There is no information on the level of out-of-pocket costs in the usual-pay group. As co-pays increase, medication adherence goes down. We don't know if Aetna's pharmacy benefit is typical of the rest of the market.

DMCB insights:

1. The possibility of $5 million (or more if compliance can be increased beyond 41%) in savings may make paying patients to take their pills seem reasonable.  Silly you say?  Think again.

2. Since $5 million in cost reductions that can result from just a 10% swing in medication compliance, readers should gain a better appreciation on the stakes behind disease management.  If nurses can talk patients into taking their pills, the downstream savings can be potentially huge.  And why stop there, why not combine no out-of-pocket costs with disease management?

Summary:

While the authors dutifully report that the primary outcome of the study (the number of first non-fatal or fatal heart attacks or some type of heart procedure) was the same in both groups, the DMCB remains impressed that free drugs for heart attack patients may be worth it and that Oncle Karl may have been right and that the University of Michigan VBID folks are on to something.  That's because the total number of events achieved statistical significance and there were some specifics that may have blunted the study's ability to get at the other outcomes.

Image from Wikipedia

Asynchronous Prescribing: A Primary Care Divorce and the Basis for Medication Irreconciliation

The Disease Management Care Blog welcomes this essay from a physician colleague.

When I first started in practice, face-to-face “medication reconciliation” was built into my drug prescribing.  The prescriptions were written by hand at the time of the clinic visit and each one, including the dosing and their purpose, were discussed with the patient.  New prescriptions by physician-specialists were noted during the time of the initial history taking, meds that the patient stopped on their own and the reasons why were reviewed, intolerances to recently prescribed meds were discussed, allergies were updated, and side effects were explained.  Prescriptions were written for one month supplies and enough refills were given until the next encounter.  They were then handed to the patient.  If there was a problem, I could count on my patient to notify me right away.

As time went on, things changed.  Thanks to how many pharmacy benefits plans are run, mail order prescriptions are now typically given for ninety days with four refills.  I think of this as medication irreconciliation.

While ninety days may look like a good idea, for the primary care physician, this was the beginning of a divorce between medication prescribing and the clinic visit.  Face-to-face medication reconciliation is no longer synchronized with the doctor visit.  Since this now asynchronous disconnect allows patients to skip appointments and continue medications, many physicians no longer

1) perform frequent medication reconciliations and

2) use the reconciliation process to monitor their patients.  

This problem is greatest for those diseases that require more than annual visits.  Instead of using the medication reconciliation process to follow complex hypertensive, hypercholesterolemic or diabetic patients every three months, one-on-one appointments, because of skipped appointments, are now happening annually.   This has made it difficult to schedule other appropriate preventive interventions such as testing, preventive screening and immunizations such as flu shots and other timely care.  

This was the reason that primary care often wrote prescriptions that were only good until the next encounter.  As Reaganites like to quote “Trust and Verify”.

It doesn't stop there.  What has finalized the divorce between the drug and the visit is the new auto refill program being used by many pharmacies (examples are here and here).

Thanks to auto refill, the patient and physician are even more disconnected with each other.  Under this system, expired refills prompt automatic refills requests that are not patient or physician initiated.  I have found in my practice that these auto refills are often for discontinued medications.  What’s worse, I have also received refill requests from pharmacy benefit managers that have apparently opened expanded operations in the afterworld for deceased patients. Humorously, one note attached for the deceased patient’s request stated that he was expecting to pick it up at 11 am on Thursday.

I am not the only one who has noticed this (here and here).

This divorce between face-to-face visits with my patients and medication prescribing has made the problem of “medication irreconcilation” even worse. It’s now necessary to reconcile each and every prescription asynchronous with the office encounter.  This may be efficient for the pharmacy providers, but it is disastrous for primary care and dangerous for patients.  For many primary care physicians, the best time to reconcile medications is when all parties are present.  During a traditional office visit, patient labs and tests are reviewed, vital signs are taken, the history is updated and an exam is performed.  That’s the perfect time when all the appropriate medications for an appropriate length of time should be prescribed.

Thanks to the divorce, accurate reconciliation has become at times impossible.  Physicians can’t use clinic visits to query their patients about new developments in their care or new prescriptions by other providers.  New doses can’t be reviewed, compliance can’t be discussed and patient concerns can’t be addressed. 

This divorce between prescribing and seeing the patient has become grounds for irreconcilable differences.  It sure was easier when it was the other way around.

Retail Pharmacists Doing Care Management Coaching? Doubtful.

Can retail pharmacists take the lead in care management-style patient coaching? To answer that, check out this New York Times article and this description of Asheville Project (more details here). Pharmacists receive extensive instruction in patient education and consumer surveys consistently show high levels of trust in community pharmacists. Pharmacists also have the advantage of "teachable moments" when consumers return to renew their prescriptions, especially if value-based insurance designs are incenting patients to pay attention. There are oodles of studies that show that, compared to usual care, pharmacists can increase health care quality and/or reduce costs (for example, here, here and here).

Full steam ahead, right?

Maybe not. The methodologically nudninky DMCB notes the Asheville data (here, here and here again) seem to be based on more than a fair share of suspect pre-post study designs and use approaches that aren't necessarily generalizable to all community/retail settings. The DMCB also worries that:

• Next to physicians, pharmacists are among the most expensive health care professionals. Education can be done more cheaply by other highly trained, credentialed non physicians.


• Despite the logic of using retail setting, setting up a separate window or a cubicle between the foot insole displays and the reading glasses tower isn't really conducive to patient engagement


• While some retail pharmacists embrace patient education, most got into retail pharmacy because they, well.... like fill the pills n' bill retail pharmacy. Pharmacists in other settings with a greater emphasis on patient education/coaching -- such as hospital-based consulting services (which work quite well in the area of anticoagulation), disease management programs, the medical home or within pharmacy benefit management companies -- are there because their professional goals may be different.

It may be that the DMCB is wrong. It may be that retail pharmacies are retooling for a new wave of disruptive innovation, that there are generalizable and prospective randomized trials that have been overlooked and that, when the DMCB went to its community pharmacy window, joked about getting some educatin' and the pharmacists chuckled along, it misread things.

If so, it'd like to hear from some readers.

Managed Care Pharmacists and the Medical Home: The Disease Management Care Blog Examines the Prospects for Collaboration

The Disease Management Care Blog recently had the pleasure of lecturing at the annual meeting of the Academy of Managed Care Pharmacy (AMCP). As readers may imagine, this professional organization provides advocacy, outreach and education services for persons – mostly pharmacists – involved in the pharmacy plans for health insurers. The DMCB provided an AMCP educational service by offering up a session on the merits of the chronic care model and the medical home.

While most of the 80 or so pharmacists in the room knew all about disease management, few had heard of the ‘chronic care model’ or the ‘medical home.’ In its commentary, the DMCB noted that managed care pharmacists can play an important role in helping enrollees/patients be more knowledgeable participants in their own treatment plans. A post-lecture survey indicated most of the attendees agreed the concepts of the chronic care model had merit. Thanks to the DMCB, that’s 80 more health professionals who know about the medical home.

The DMCB isn’t optimistic this will make much of a difference, however. That’s because it knows that the pharmaceutical insurance plans are typically ‘shielded’ from the standard health insurance policies that they are paired with; they are sold as a ‘rider’ with their own benefit designs, underwriting, cost structure and premiums. For an example of how this works, see here.

As a result, most of the business-as-usual pharmacy leaders that were in the room have little economic incentive to coordinate their pharmacy insurance products with all that other ‘medical stuff’ going on back home. In fact, under most circumstances, they have an incentive to ‘transfer’ their pharmacy costs to the standard insurance plan. If this sounds like health care silos at their worst, you’re right.

For example, certain injectable medicines can be administered in a physician’s office (making them eligible to be covered as a medically necessary service) or at home (making them resemble any other drug that persons need to take on their own). Given a choice, the likelihood that any pharmacist would welcome these drugs' cost into the budget is inversely proportional to their price. Yet, it is the precisely the conditions treated by the high cost injectables (such as cancer or connective tissue disorders) that may benefit from close coordination with the involvement of knowledgeable pharmacists in care management services. The pharmacists’ response? Why take on the expense of taking on any of these services when that additional cost will make their insurance product less competitive and less profitable? In fact, a really good education program could attract chronically patients, further stressing the budget.

If this reminds you of the tension between physicians and managed care insurers, you’re right. Primary care physicians have also pointed out that they’re vulnerable to taking on the cost of patient education and empowerment while the financial benefit goes to the insurance company.

And that’s not all. The DMCB has generally found that the really smart pharmacists that rise to the top of their organizations do so because they understand pharmacology, pharmacoeconomics and budgeting. These are brainy hardnosed businessmen and women who have less professional affinity for the squishy business of patient education and empowerment.

The DMCB predicts as awareness of the medical home grows, managed care pharmacists will support it if they believe it can reduce their costs. If (and that is a big if) they believe it reduces their drug spend, their support will consist of:

1) agreeing that the medical home should be covered by the standard insurance benefit, since better control of disease may reduce drug consumption, and/or

2) conducting outreach activities to primary care sites that function as medical homes.

Otherwise, the DMCB thinks it will be all talk and no action.

The only wild card? Pharmacy Benefit Managers (aka PBMs). The DMCB thinks their value as intermediaries between the pharmaceutical manufacturers and the managed care plans is becoming increasingly commoditized. Their position will become even more tenuous if price controls are pursued by the Obama Administration. To maintain their market share, expect more of them to offer not only disease management services but active support for medical homes on a 'value added' basis without any expectation of lower costs.