Care That Fits Blog

Submitted by Paige Organick

As exemplified with Drew Calver¹, the Texas high school teacher rushed to the hospital for life saving treatment after a heart attack in 2017, our current healthcare system is neither careful nor kind. From the hospital bed, he worried about affording his care, but was reassured his insurance would cover all expenses. Nonetheless, his initial bill totaled $108,951 after insurance, partly because his hospital was not in his employer’s insurance network.

Calver’s case demonstrates part of the high treatment workload patients undergo to afford their care. If they’re lucky enough to be insured, they must do a lot of cognitive work to figure out if their provider is in-network or not. After treatment, patients wage small and numerous battles with insurance to prevent bankruptcy by a bill magnitudes higher than those in similarly developed countries.

Due in part to a complicated patchwork of fragmented insurance and healthcare providers, administrative complexity has made the US the top spender on healthcare in the world with some of the lowest health outcomes. Americans, compared to similarly wealthy and developed countries, have a shorter life expectancy, higher rates of disease, the highest rate of infant mortality, and the lowest chance of making it beyond middle age².

Image from Peterson-Kaiser Health System Tracker

Some of these health outcomes could be improved through Senator Sanders’ proposed Medicare for All act, which would better prioritize preventative care measures. 49% of Americans have employer-insurance⁴, and as they move jobs their insurance changes, then once they hit 65 they move to Medicare. Insurance companies provide treatments rather than continual maintenance of overall health, passing the buck on to the next payer for incentivizing healthy living and preventative care programs. However, under a single-payer system, the government would be greatly incentivized to fund public health and preventative care measures, keeping the population healthier and in less need of healthcare, similar to other Western countries.

Medicare for All would decrease patient’s treatment workloads Under a single-payer system, Calver would not have needed to worry about being in the right hospital, or having the right doctor in the wrong hospital, in order to afford his care. And although Calver had a crushingly high bill, his bill would have been even higher without insurance, as the 29 million uninsured Americans would have faced. When care is this expensive and this administratively complex, navigating care becomes stressful, causing people to either avoid the doctor’s office altogether or to avoid routine care, only seeking care when they need hospitalization or expensive procedures.

However, Medicare for All won’t be a panacea for our healthcare system. Despite Medicare for All increasing access to care, it may restrict certain services and procedures. If 29 million more Americans suddenly accessed healthcare, there would be a shortage limiting access to certain services such as access to doctors and limited supplies of medications. Additionally, Medicare for All would only cover a contested list of “medically necessary” procedures. This list ranges from the obviously important, like breast cancer screenings, to colonoscopies. What it may not include is prescription drugs for fertility, weight loss, or potentially abortions, as they are so hotly contested right now. Calver’s procedure may have been unavailable due to medical shortages, or some aspects may not have been covered.

America is at a crossroads, and how we move forward reveals what we value in healthcare and the treatment of fellow citizens. Our current industrialized healthcare system benefits those with good insurance and who can afford care. These lucky patients enjoy some of the best diagnostic treatment and advanced procedures in the world. While Medicare for All would potentially limit access to some treatments, it overall would bring other benefits that emphasized overall population health, an arguably more careful and kind approach. The passage of Medicare for All would mark a massive shift in America’s values, evolving the rugged individualism America was founded on into making room for a more communal, equality based healthcare system.

¹ “Life Threatening Heart Attack Leaves Teacher with $108,951 Bill”. NPR Morning Edition. https://www.npr.org/sections/health-shots/2018/08/27/640891882/life-threatening-heart-attack-leaves-teacher-with-108-951-bill

² “For Americans Under 50, Stark Findings on Health”. Sabrina Tavernise. The New York Times. https://www.nytimes.com/2013/01/10/health/americans-under-50-fare-poorly-on-health-measures-new-report-says.html

³ “Mortality Rate, Infant (per 1,000 live births)”. The World Bank.  https://data.worldbank.org/indicator/SP.DYN.IMRT.IN

⁴ “Health Insurance Coverage of the Total Population”. Henry J Kaiser Family Foundation. https://www.kff.org/other/state-indicator/total-population/?currentTimeframe=0&sortModel=%7B%22colId%22:%22Location%22,%22sort%22:%22asc%22%7D

Submitted by Paige Organick
Illustrations by Kevin Shaw

Senator Warren and Representative Schakowsky introduced the Affordable Drug Manufacturing Act in December of 2018. This act would require Health and Human Services to publicly manufacture generic drugs if one of the following conditions are met:

• Two or fewer companies produce the drug
• There is a drug shortage
• The price of a drug has created a barrier to patient access.

Should it pass, this bill would be consequential. Currently, 40% of generic medicines are made by just one drug maker. Monopolies like this contribute to soaring drug prices that exclude patients who fill nine out of every ten prescriptions with generics.¹ By breaking the generics monopoly and promoting competition, the act’s intent is to improve the affordability of medicines for most patients, even those still under patent protection.

Out-of-pocket costs are important in making treatment decisions for at least 80% of patients.² By addressing the financial burden of treatments, this bill could support what we at the KER Unit call “minimally disruptive medicine”. Faced with expensive medications, patients, especially those with multiple chronic conditions must choose between buying groceries, paying rent, and purchasing their medications. When they skip their medications, healthcare labels these patients as “noncompliant”. These “noncompliant” patients must then cope with preventable symptoms and complications, the care these require in turn and their costs, and the judgment often dished to them by those who blame them for not taking personal responsibility for their care.

This act, along with other proposals including the Preserve Access to Affordable Generics and Biosimilars Act, are unlikely to pass for many reasons, including the substantial campaign contributions that pharma makes to regulators.³ Yet, these initiatives may slowly erode the fabricated consensus that market forces alone can solve the problem of drug affordability, and re-energize the role that regulation can play in creating affordable healthcare.

¹ Why pharma companies are bowing out of generics”. Dan Gorenstein. Marketplace on NPR. https://www.marketplace.org/2017/08/02/health-care/drug-prices-why-pharma-companies-are-bowing-out-generics

² “Talking About Costs of Care During Shared Decision Making – Part One: The Problem”. Alan Balch. Journal of Clinical Pathways. https://www.journalofclinicalpathways.com/article/talking-about-costs-care-during-shared-decision-making-part-one-problem

³ “Database Details Drugmakers’ Contributions to Congress”. Emmarie Huetteman and Sydney Lupkin. CNN News. https://www.cnn.com/2018/10/25/health/drugmakers-congress-contributions-partner/index.html

This is a reprint of a previous publication held on guidelines.gov. We will work to update information within in coming blog posts.

By: Aaron L. Leppin, MD and Victor M. Montori, MD, MSc

Currently, half of all American adults have a chronic disease and 1 in 4 live with the burdens of multiple, concurrently active chronic conditions (1). The population is aging and the incidence and prevalence of chronic disease are increasing. As such, typical patients with any chronic condition are increasingly likely to be patients with multiple chronic conditions (MCC). Patients with MCC are a priority population and Federal stakeholders have called for new and effective ways of meeting their healthcare needs (2,3). Optimizing clinical practice guidelines for the care of patients with MCC could play a key role in this regard.

The Dilemma for Clinical Practice Guidelines

Clinical practice guidelines, for scientific and practical reasons, orient themselves around the management of specific diseases or clinical circumstances. They provide condition-specific guidance on how one would optimally manage a disease if and when that condition existed in a vacuum, independent of any interacting or intervening factors. This understanding is necessary, but, in many cases, does not directly or reliably apply to the care of an individual person—especially a person with MCC (4).

Although all patients exist in unique biopsychosocial contexts, the care of patients with MCC is particularly complicated by the interaction of multiple, concurrently active chronic conditions. When individual, disease-specific treatment strategies are pursued for these patients—indiscriminately and in parallel—the resulting care can be ineffective, impractical, and unsafe (5,6). Advocates of patient- or person-centered care recognize that the best way to manage complex patients is with comprehensive and flexible treatment strategies that can adapt to the nuances of individual contexts.

Guideline developers who desire to incorporate and encourage this understanding face a key dilemma. Person-centered disease management strategies, by their very nature, lack the disease specificity to fit into traditional, disease-oriented practice guidelines. The inability of guidelines to incorporate person-centered recommendations accentuates the significance of this dilemma by ultimately limiting the guidelines’ usefulness.

Consider Stanford’s Chronic Disease Self-Management Program (CDSMP), for example. The CDSMP is a group-based, disease-agnostic self-management program designed to generically enhance patients’ capacity to deal with the burdens of chronic disease. Participants select which self-management strategies they will use from a menu of options and according to their preferences. They also prioritize the conditions or issues they will seek to address based on their own perceptions of context, need, and ability. The body of evidence related to the CDSMP suggests that it improves patient-reported outcomes regardless of patient diagnosis (7,8). As such, CDSMP implementation is a key priority of the Department of Health and Human Services’ effort to optimize the care of patients with MCC (2) and the Centers for Disease Control and Prevention has recommended it become part of routine care for all patients with any chronic condition (8).

Arguably, the CDSMP should be a component of clinical practice guidelines for every chronic condition, and yet it appears in none. One reason for this, paradoxically, is that person-centered approaches to chronic disease management are rarely the best option for optimal management of any single disease if and when that disease existed in a vacuum. The CDSMP is not the most efficacious treatment for depression, for example, nor is it the most efficacious treatment for diabetes or arthritis or cancer. But what is the single best intervention for a patient with depression, diabetes, arthritis, and cancer? The answer to this question is not currently known, but to a patient living in that context—and to the clinician caring for him or her—it remains the most important question to have answered.

The Opportunity for Person-centered Guidelines

Some guideline developers have succeeded in incorporating person-centered recommendations into clinical practice guidelines. Examples include advocating for the use of clinical judgment in formulating treatment plans and for using shared decision-making strategies that incorporate patient values, preferences, and priorities. These recommendations are useful but, in contrast to their more traditional and disease-focused counterparts, they encourage things that are often difficult to identify, operationalize, and enact—such as attitudes or concepts. The ultimate and practical value of clinical practice guidelines rests in their ability to provide direction on what to do (and, implicitly, measure). This is straightforward in some clinical circumstances, but in the setting of chronic disease—and especially among patients with MCC—it is rarely obvious or clearly actionable. The key challenge and opportunity for clinical practice guidelines for chronic disease management, then, is to identify a mechanism for translating person-centered intentions into clearly described and actionable clinical activities.

Minimally Disruptive Medicine as a Proposed Solution

In an effort to guide understanding in this regard, our research team at Mayo Clinic has spent the last 5 years developing a patient-centered and context-sensitive model of care called minimally disruptive medicine (MDM) (9). Our particular contributions add to and draw from those of the International Minimally Disruptive Medicine Workgroup (www.minimallydisruptivemedicine.org ) and are informed by the synthesis of insights from our own internally and externally funded research projects, the engagement of key and diverse stakeholders, and ongoing and reflective transdisciplinary discourse.

In summary, and in the simplest sense, MDM describes patient context as a balance between workload and capacity. Workload comprises all the things patients must do (physically, cognitively, or otherwise) to be well and to fulfill meaningful goals for and roles in life and health. In the complex circumstances of individual patients with MCC, the unique compositions of workload will vary—inevitably including contributors from health, healthcare, and life—but the resulting construct emerges as an experience that is consistent and relatable—namely, a burden. Capacity comprises all the resources—physical, mental, social, financial, personal, and environmental—that patients with MCC can mobilize to carry out the work of life, health, and healthcare, and, in turn, counteract or avoid the experience of burden.

For patients with MCC, capacity is always at risk of being overwhelmed. As the limits of capacity are breeched, patients begin to experience care as a disruption to their lives. They may begin to haphazardly prioritize aspects of the workload that are feasible, but of little value. In these cases, patients are prone to clinical and personal decompensation. It stands to reason, then, that for health care to be effective for patients with MCC, special efforts must be taken to augment the balance of workload and capacity so that it favors the patient (10). The advantage of this conceptualization—which itself derives from a synthesis of mathematical, psychological, and social underpinnings—is that it serves to make sense of patient context (11). For guideline developers, this also begins to overcome the challenge of translating person-centered intentions into clinically actionable recommendations. Such recommendations are necessary to facilitate the development of person-centered quality metrics that are more appropriate for patients with MCC.

Recommendations for Consideration

To extend the applicability of clinical practice guidelines to patients with MCC, we present three strategies that are consonant with a person-centered approach based in MDM. In order of increasing complexity and uncertainty, they are:

1. The MCC caveat: a simple statement that acknowledges the limitations of disease-centered treatment recommendations for patients with MCC. This statement should serve to reduce clinicians’ expectation that following a recommendation—especially when it is not strong—will do more good than harm. It should also alert policy-makers to the potential disservice done to patients with MCC when disease-centered recommendations are linked to quality metrics that guide incentives and practice.
2. The MCC context assessment: an explicit recommendation for the assessment of patient context before applying disease-centered treatment recommendations. These assessments should include an evaluation of patient workload and capacity. As an example of a workload assessment, Mair and May have proposed a question as simple as “Can you really do what I am asking you to do?” (12). Ideally, this question should follow a careful consideration of and deliberation about what should be done.
3. The MCC treatment optimization: a proactive adaptation of the disease-centered treatment recommendation based on understandings elicited from the context assessment. In accordance with a MDM approach, this amounts to enacting efforts to support patient capacity to implement essential care and/or removing non-essential care and tailoring treatment approaches to something more feasible and effective. For example, a patient-centered guideline for diabetes management in the context of MCC might read:

If the MCC context assessment suggests that optimal diabetes-oriented care is likely to be ineffective or impractical for the patient at this time, the clinician—in partnership with the patient—should look for opportunities to remove low value and excessively burdensome care (including unnecessary testing and appointments), regardless of indication. If no such care is identified or if its removal does not sufficiently change the patient’s context, patient-centered adaptations of the diabetes treatment strategy outlined here may be pursued. In order to do this, the clinician should first partner with the patient to assess the relative value of optimal diabetes-oriented care in achieving important patient goals. If this value is judged to be low, the clinician and patient can consider temporarily modifying or suspending diabetes-oriented treatment targets (e.g., HbA1c targets) and/or changing management strategies (e.g., by changing from insulin to an oral antidiabetic medication) to better fit patient preference and capacity. Alternatively—and if optimal diabetes-oriented care is essential for achieving important patient goals—supportive efforts should be taken to enhance patients’ capacity to fit this care into their lives (e.g., by connecting patients to community-based resources that can help with transportation, prescription refills, self-care).

A key and inherent limitation of person-centered clinical practice guidelines is that they will never be able to provide patient-specific recommendations for how to adapt disease-centered guidelines. What they can do is provide conceptual direction on how such adaptations should be made. MDM may provide a framework for orienting this guidance and for making sense of the application of patient-centered clinical wisdom. To that end, we have proposed and organized a flexible toolbox of interventions that clinicians can use to match their efforts to the unique contexts of patients with MCC (11).

Conclusion

Certainly, guidelines must continue to communicate what the best science supports for optimal management of a given disease if and when that condition existed in a vacuum. As the prevalence of MCC rises however they must also provide specific, actionable, and patient-centered guidance on what is practically feasible, technically safe, and ethically appropriate in each setting. Traditionally, professional societies and guideline panels have focused on the former. America needs bold and innovative guideline developers willing to focus on the latter. When guidelines change, policy and practice can follow. To the extent this occurs, patients with MCC could be the first to reap the benefits.

Authors

Aaron L. Leppin, MD
Assistant Professor of Health Services Research
Knowledge and Evaluation Research Unit
Mayo Clinic
Rochester, Minnesota

Victor M. Montori, MD, MSc
Professor of Medicine
Knowledge and Evaluation Research Unit
Mayo Clinic
Rochester, Minnesota

Disclaimer

The views and opinions expressed are those of the author and do not necessarily state or reflect those of the National Guideline Clearinghouse™ (NGC), the Agency for Healthcare Research and Quality (AHRQ), or its contractor ECRI Institute.

Potential Conflicts of Interest

Dr. Leppin states the Mayo Clinic research was supported by funding from NIH and AHRQ. No support was received from industry of any kind. Both authors declare no financial or personal conflicts of interest with respect to this commentary.

References

1. Ward BW, Schiller JS, Goodman RA. Multiple chronic conditions among US adults: a 2012 update. Prev Chronic Dis. 2014;11:E62.
2. Department of Health and Human Services. Multiple chronic conditions—A strategic framework: Optimum health and quality of life for individuals with multiple chronic conditions. Washington (DC): Department of Health and Human Services; 2010.
3. Parekh AK, Kronick R, Tavenner M. Optimizing health for persons with multiple chronic conditions. JAMA. 2014;312(12):1199-200.
4. Wyatt KD, Stuart LM, Brito JP, et al. Out of context: clinical practice guidelines and patients with multiple chronic conditions: a systematic review. Med Care. 2014 Mar;52(Suppl 3):S92-100.
5. Boyd CM, Darer J, Boult C, Fried LP, Boult L, Wu AW. Clinical practice guidelines and quality of care for older patients with multiple comorbid diseases: implications for pay for performance. JAMA. 2005;294(6):716-24.
6. Dumbreck S, Flynn A, Nairn M, et al. Drug-disease and drug-drug interactions: systematic examination of recommendations in 12 UK national clinical guidelines. BMJ. 2015;350:h949.
7. Ory MG, Ahn S, Jiang L, et al. Successes of a national study of the Chronic Disease Self-Management Program: meeting the triple aim of health care reform. Med Care. 2013 Nov;51(11):992-8.
8. Brady TJ, Murphy L, Beauchesne D, et al. Sorting through the evidence for the Arthritis Self-Management Program and the Chronic Disease Self-Management Program, executive summary of ASMP/CDSMP meta-analyses. Atlanta (GA): Centers for Disease Control and Prevention; 2011 May. 30 p.
9. May C, Montori VM, Mair FS. We need minimally disruptive medicine. BMJ. 2009;339:b2803.
10. Leppin AL, Gionfriddo MR, Kessler M, et al. Preventing 30-day hospital readmissions: a systematic review and meta-analysis of randomized trials. JAMA Intern Med. 2014;174(7):1095-107.
11. Leppin AL, Montori VM, Gionfriddo MR. Minimally disruptive medicine: a pragmatically comprehensive model for delivering care to patients with multiple chronic conditions. Healthcare. 2015(3):50-63.
12. Mair FS, May CR. Thinking about the burden of treatment. BMJ. 2014;349:g6680.

We are pleased to present our 2017 Annual Report.  A special thank you to Keven Shaw for putting it together.

AnnualReport2018