Clinical Pathways: Expanding Beyond Pharmaceuticals

 J Clin Pathways. 2022;8(3):28-30. doi: 10.25270/jcp.2022.4.2

Providers order unnecessary tests for a variety of reasons: pressure from patients, fears of malpractice suit, not being knowledgeable about current “best” practices as well as for potential financial advantage for them or their health system. Clinical pathways built on solid clinical guidelines have the potential to lower costs through reduced resource utilization of potentially unnecessary screenings, tests, and procedures. But clinical pathways are not effective if not implemented. Formal mandate of clinical pathways may be on the horizon, but enforcement has been historically slow in this sector of care.

Terms & Process

Take for example the use of the term nonpharmacologic. By describing all other therapeutics as simply ‘nonpharmacologic’ gives the impression that the foundation is pharmacologic therapies with all others playing a much more secondary role. This of course misses a growing opportunity to expand the use of other therapeutics such as those targeting Social Determinants of Health or Digital Therapeutics. 

Beyond our use of terms, even our processes favor pharmacologic. The fact that pharmacologic enjoy their own insurance benefit to the current exclusion of other therapeutics is yet another example of this basis. Medicare Part D is the unique Medicare benefit that provides coverage for a large range of pharmaceuticals but currently limits this to pharmaceuticals only.

The fact that pharmacologic therapeutics are regulated by the Food and Drug Administration (FDA), most often requiring access via a licensed physician’s prescription, is additional evidence of their favor. There are of course a growing number of therapies that are available outside FDA regulation and that of a physician prescription these treatments are rarely covered by insurance or included in clinical pathways despite their proven benefits. These include treatment options such as acupuncture or massage therapy.

To move away from this basis requires both a change in our nomenclature and processes. To begin ‘nonpharmacologic’ should be replaced with specific terminology such as Digital Therapeutics or Social Determinants of Health (SDOH) Interventions. By being specific in the form these therapies cover as well as including them in clinical pathways will elevate them to their appropriate level of consideration and use.

Social Determinants of Health

The growing focus of SDOH as factors and opportunities to improve both clinical and financial outcomes should be followed by their inclusion in clinical pathways. This requires process for their identification of needed addressing for specific patients and populations. Once identified there needs to be a process for filling their gap.

Coverage for SDOH services is now being provided by Medicare Advantage plans. Since 2019, Medicare Advantage plans were permitted to provide coverage for a wide variety of non-medical benefits as CMS moved to provide improved coverage for SDOH needs. The Centers for Disease Control (CDC) defines SDOH  as the conditions in which people are born, grow, live, work, and age. SDOH are shaped by the distribution of money, power, and resources throughout local communities, nations, and the world. Inclusion of these interventions within clinical pathways would improve their use by payers and providers to the benefit of clinical and financial outcomes.

Digital Therapeutics

Digital Therapeutics (DTx) are typically defined as evidence-based therapeutic interventions driven by software to prevent, manage, or treat a medical disorder or disease. Digital Therapeutic inclusion in clinical pathways was specifically addressed in a recent article in this journal.²  The inclusion of digital therapeutics in clinical practice is being advanced by not only the FDA through recognition of prescription DTx but organizations such as United States Pharmacopedia (USP) which is evaluating their inclusion in their model formulary guidelines.

USP was assigned the task of developing Model Guidelines in the Medicare Prescription Drug Improvement and Modernization Act of 2003 (MMA). And while this applied the classification of therapeutic uses for covered Part D drugs many Commercial payers rely on the USP model formulary guidelines, as a result they have been developed to include therapies outside of those covered under Medicare Part D. As FDA, USP and others move to include digital therapeutics it seems increasingly appropriate for clinical pathways to include these therapies as well.

Deprescribing

Shifting away from pharmaceuticals means not only including other treatments for consideration but recommending the removing of pharmaceuticals when they are no longer of benefit. Again terms are commonly used that promote the use of pharmaceuticals even when there is no clear benefit for specific patients. Currently terms such as ‘Low Value Medications’ are used to describe medications where the benefits are exceeded by the clinical and financial costs. Of course when costs exceed benefits by definition these are actually ‘Negative Treatments’. Yet despite this reality the term low value medication is still widely used over the technically correct negative treatments.³  Here too clinical pathways can correctly identify treatments that are potentially negative for individual patients such that they are not only not started but discontinued when patients cross this line.

There are groups and efforts calling out these negative treatments such as the Choosing Wisely Campaign or Canadian Deprescribing group. Both efforts provide a foundation for clinical pathways to build upon to improve clinical and financial outcomes. The Deprescribing.org website  was developed by a pharmacist and physician and their research teams at the Bruyère Research Institute (Ottawa) and Université de Montréal. Their vision for this resource is to share and exchange information about deprescribing approaches and deprescribing research with the public, health care providers and researchers.

Choosing Wisely  is an initiative of the American Board of Internal Medicine (ABIM) Foundation that seeks to advance a national dialogue on avoiding unnecessary medical tests, treatments and procedures. Since 2012, national organizations representing medical specialists have asked their members to identify tests or procedures commonly used in their field whose necessity should be questioned and discussed. Both Choosing Wisely and Deprescribing resources can be incorporated into clinical pathways to best identify opportunities where pharmaceutical therapies are no longer appropriate. 

Change…

In the end, our reliance on pharmaceuticals has disadvantaged a growing array of other therapeutic options. To provide greater inclusion of these opportunities we must begin by expanding our terminology, adjusting our processes both regulatory and access. In addition, our clinical pathways must include these options through their identification of appropriate patients and use. These changes in our own clinical pathways will greatly expand our treatment options, providing significant improvement in both clinical and financial outcomes. 

References

1. US Centers for Disease Control and Prevention. Social determinants of health. Updated October 23, 2020. Accessed March 28, 2022. https://www.cdc.gov/publichealthgateway/sdoh/index.html

2. Stefanacci RG, Culjat M, Abraham BC. Digital health placement in clinical pathways J Clin Pathways. 2020;6(10):37-40. doi:10.25270/jcp.2020.12.00004

3. Stefanacci RG. Negative treatments… Changing our words to drive deprescribing. J Am Geriatr Soc. 2021;69(11):3333. doi:10.1111/jgs.17452

4. Bruyère Research Institute. Deprescribing. Accessed March 28, 2022. https://deprescribing.org/

5. ABIM Foundation. Choosing wisely. Accessed March 28,2022. https://www.choosingwisely.org/

Author Information

Author: Richard G. Stefanacci, DO, MGH, MBA, AGSF, CMD

Affiliation: EVERSANA™, Berkeley Heights, NJ

Disclosures: Dr Stefanacci has served as a Sanofi Scientific Education Program speaker as well as chief medical director for the managed markets agency of EVERSANA™.