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Healthcare Policy Paper: H.R. 3537

Olivia Engle
Walsh University Byers School of Nursing
NURS 706: Healthcare Policy
April 24, 2022
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Healthcare Policy Paper: H.R. 3537

Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease that

affects the nerves and spinal cord and eventually leads to death. Unfortunately, there is no cure

for this illness and treatment methods are limited. There is a limited understanding of

neurodegenerative diseases like ALS due to a lack of research surrounding these diseases.

Without understanding the cause and diagnosis of a disease, developing a treatment or cure will

be unlikely. It is through healthcare policy that many advancements in healthcare are made.

There has been little advancement in the treatment of amyotrophic lateral sclerosis (ALS) and

other neurodegenerative diseases because of restrictive eligibility for clinical trials and a limited

understanding of the pathophysiology of the disease. Accelerating Access to Critical Therapies

for ALS Act (H.R. 3537) expands the amount of research that can be done on rare

neurodegenerative diseases.

It is not uncommon for neurodegenerative diseases to be under researched which means

there is very little understanding of these diseases and often no cure and limited treatments.

Better understanding of the pathophysiology behind these diseases will not only allow for the

development of treatment methods but will also help to determine possible interventions to

prevent them. There has been limited research done on ALS for multiple reasons. According to

Eijk et. al (2021), funding for research has been very limited and the cost for researching

neurodegenerative diseases is very high. Researchers, especially those at nonprofit organizations,

are unlikely to perform research on these diseases without some sort of funding.

Clinical trials for ALS are often very limiting regarding the patients that they allow to be

a part of them. Because of the heterogenous nature of the disease, meaning variability in the

presentation of the disease, many patients end up excluded from clinical trials because they do

not meet certain criteria (Eijk et. al, 2021). These exclusions lead to data that is not
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Healthcare Policy Paper: H.R. 3537

generalizable. Poor generalizability means that research can only apply to a very narrow group of

people. It is also important to note that even when patients can be a part of a clinical trial, they

may be a part of the placebo and receiving no treatment. There was a need for change regarding

the research behind neurodegenerative diseases, and therefore H.R. 3537 was developed.

The Accelerating Access to Critical Therapies for ALS Act provides funding to both

private and public entities to research ALS. This bill was signed into law in December of 2021

and was created in response to the lack of understanding and treatment for neurodegenerative

diseases such as ALS and is the first federally funded effort into research behind ALS (H.R.

3537, 2021). Not only will this bill provide funding for the research of treatments but will also

fund research about the disease itself including its cause and diagnosis. By funding both private

and public entities this expands the amount of research that can be done. Grants will be provided

by the Food and Drug Administration (FDA) to fund research for treatments of

neurodegenerative diseases (H.R. 3537, 2021). These grants will hopefully expedite the

development of treatments for these diseases. Under this bill, the department of health and

human services will create a partnership between the FDA, national institutes of health and at

least one other entity to support the development and evaluation of drugs that treat

neurodegenerative diseases (H.R. 3537, 2021). H.R. 3537 will provide grants to entities that

offer access to investigational treatments for ALS to patients that are excluded from other

clinical trials.

Developing research and new treatments should be a collaborative process.

Interprofessional collaboration occurs when two or more disciplines work together towards a

common goal (Green & Johnson, 2015). For patients with ALS and other neurogenerative

diseases, there are many members that are a part of their team. This includes physicians, nurse
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Healthcare Policy Paper: H.R. 3537

practitioners, physical and occupation therapists, nurses, and pharmacists, among others. In

healthcare, interprofessional collaboration can help greatly to improve patient outcomes (Green

& Johnson, 2015). All these team members can provide valuable information regarding the care

and treatment patients with ALS that would be beneficial to the research being done. On a larger

scale, H.R. 3537 promotes interprofessional collaboration between nonprofit and for-profit

entities. Interprofessional collaboration in research is often the necessary tool toward making

innovations in healthcare.

DNPs have a unique perspective when it comes to input on healthcare research.

According to Edwards et. al (2018), DNP prepared nurses are becoming leaders in healthcare

policy in addition to implementing evidenced-based practice. DNPs can implement their

understanding of practice into research surrounding neurodegenerative diseases and take on a

leadership role in developing new treatment methods. In addition to leading research and policy,

DNP prepared nurses can also be at the forefront of implementing new diagnostic and treatment

strategies.

When a healthcare policy is put into place, it is important that there are steps taken to

evaluate the policy. The government accountability agency (GOA) is a part of the legislative

branch that provide evaluation and audits for congress. This agency is essentially responsible for

providing information to congress that will ensure that money is being spent appropriately (U.S.

Government Accountability Agency, n.d.). Any grant under H.R. 3537 must be presented to

congress by the GOA. Each grant will be evaluated for their effectiveness in developing

treatment methods for ALS. In addition, the food and drug administration (FDA) must provide a

five-year plan for the development of drugs to treat neurogenerative diseases (H.R. 3537, 2021).
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Healthcare Policy Paper: H.R. 3537

Agencies such as the GOA help to set standards for healthcare policies and ensure that resources

are being used properly.

When completing healthcare research regarding a certain disease or treatment method, it

is important to consider how it will be implemented into practice. Several factors are involved in

the implementation of new healthcare treatments and diagnostic technology. Current treatment

methods for ALS and neurodegenerative diseases are used to improve quality of life and prolong

the lifespan as there is no curative treatment (Hobson & McDermott, 2016). There is also no

current test to diagnose ALS, and diagnosis often involves a history and physical and testing to

rule out other neurodegenerative diseases. The goal of H.R. 3537 is to further the knowledge

surrounding ALS (and other neurodegenerative diseases), and this includes advancements in the

diagnosis and treatment of the disease.

It takes on average seventeen years for evidence-based practice to be implemented into

hospitals or clinics (Luciano et. al, 2019). Implementation of new practices in healthcare is

usually not an easy process. When new diagnosis and treatments are being developed, they go

through an approval process before implementation into practice. After clinical trials, treatments

undergo approval from the FDA before they are used on the public. With H.R. 3537 in place, the

FDA must provide a five-year plan for the development of drugs for neurodegenerative diseases.

Setting these standards helps to accelerate research and hold researchers accountable for

providing meaningful advancements. Once getting FDA approval, treatments may be used in

healthcare facilities which requires the training of multiple disciplines and adaptation to new

methods.
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Healthcare Policy Paper: H.R. 3537

It can be challenging to get providers to use newer treatments; however, diseases such as

ALS have so few treatment methods that any advancement should be considered by the provider.

When implementing new processes, it is important to have strong individuals to lead the

execution this may include providers such as DNPs. It is important for providers to stay up to

date on medical research so that patients are receiving the most appropriate care, and providers

should be leaders when introducing new methods into practice. Resources at the facility may also

be a factor when implementing new methods. Smaller and more rural hospitals may not be able

to obtain the newest diagnostic or treatment tools due to cost (Luciano et. al, 2019). Larger

hospital systems are often at the forefront of research and are the first to have access to cutting

edge treatments and technology. As more advancements are made, access to these treatments

should improve. It is the purpose of H.R. 3537 and other healthcare policies to hopefully

expedite the research and implementation of new treatment methods.

There are many factors involved in developing and implementing new healthcare

treatment methods. Often, lack of research and understanding of disease pathology leads to

limited diagnosis and treatment methods. This is the case with amyotrophic lateral sclerosis and

other progressive neurodegenerative disorders. These diseases affect many people and

unfortunately, once diagnosed, the prognosis is poor. Because of this, Accelerating Access to

Critical Therapies for ALS Act was developed. With this policy, funding is provided to many

different entities to advance the research of diagnosis and treatment methods and access to

clinical trials for neurodegenerative diseases. This funding helps to promote interdisciplinary

research which will hopefully lead to advancements in the understanding of neurodegenerative

diseases like ALS. Healthcare policies such are imperative to the advancement of healthcare and

treatment of complex diseases.

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Healthcare Policy Paper: H.R. 3537

References

Edwards, N. E., Coddington, J., Erler, C., & Kirkpatrick, J. (2018). The Impact of the Role of

Doctor of Nursing Practice Nurses on Healthcare and Leadership. Medical Research

Archives, 6(4).

Green, B. N., & Johnson, C. D. (2015). Interprofessional collaboration in research, education,

and clinical practice: working together for a better future. The Journal of chiropractic

education, 29(1), 1–10. https://doi.org/10.7899/JCE-14-36

Hobson, E. V., & McDermott, C. J. (2016). Supportive and symptomatic management of

amyotrophic lateral sclerosis. Nature Reviews Neurology, 12(9), 526-538.

H.R. 3537-117th Congress (2021-2022): Accelerating Access to Critical Therapies for ALS Act.

(2021, December 23). https://www.congress.gov/bill/117th-congress/house-bill/3537

Luciano, M. M., Aloia, T. A., & Brett, J. F. (2019, August 2). 4 ways to make evidence-based

practice the norm in health care. Harvard Business Review. Retrieved April 24, 2022,

from https://hbr.org/2019/08/4-ways-to-make-evidence-based-practice-the-norm-in-health-

care

U.S. Government Accountability Office. (n.d.). What Gao does. U.S. GAO. Retrieved April 24,

2022, from https://www.gao.gov/about/what-gao-does

van Eijk, R. P., Nikolakopoulos, S., Roes, K. C., Kendall, L., Han, S. S., Lavrov, A., ... & van

den Berg, L. H. (2021). Innovating clinical trials for amyotrophic lateral sclerosis:

challenging the established order. Neurology, 97(11), 528-536.