Please Read Instructions
Health Policy Paper Outline
This is the submission link for your health policy Outline. You are required to analyze your chosen health policy topic through use of the Health Policy Analysis found in chapter 14. Your points presented in your outline need to be validated with credible information from credible sources. You should include a thesis statement, in-text citations, and a reference list (with at least 5 references). You are required to follow an APA format. Please follow the sample outline found in the Assigned Course Projects page link (found in the Students Resources for HSA 6152) in our HSA 6152 canvas course.
Outline Grading Rubric
¢ Used specified format, style and length. ¢ Following APA format
¢ There are some mistakes in the APA outline format.
¢ Little to no attempt was made to follow the APA outline format
This criterion is linked to a Learning OutcomeClear and Concise
¢ Overall, outline indicates student is prepared to write the Synthesis Paper. ¢ Outline includes all promised parts of the thesis and is presented in an organized manner. ¢ Level of detail in the outline is appropriate for writing a 4 to 6 page paper. ¢ For every A there is a B, for every 1 there is a 2
¢ Writing lacks clarity or conciseness. ¢ Minor problems with sentence structure and some grammatical errors. ¢ Few errors in punctuation and spelling.
¢ Writing lacks clarity and conciseness. ¢ Serious problems with sentence structure and grammar. ¢ Numerous major and/or minor errors in punctuation and spelling
¢ The outline contains the appropriate quality and quantity of well-organized points to support and build to the thesis/topic. ¢ Each main idea contains three or more compelling or persuasive pieces of supporting evidence from appropriate sources.
¢ The outline includes some points that support and build to the thesis, but at times topics are noted that are not relevant to the thesis stated. ¢ Includes three main ideas, but one or more are not linked with any apparent logic. ¢ Each main idea contains at least two pieces of supporting evidence.
¢ Includes two or fewer main ideas. ¢ Not all main ideas contain at least one piece of supporting evidence, or the evidence is not compelling or persuasive
The outline must include: Keep in mind I have to do a powerpoint to this outline
Introduction
Definition of Health Transparency Problem
Stakeholders
Current Regulations
Policy Analysis
Recommendation
Conclusion
References
Sample Outline (what the outline should consist ) Requires 5
1. Introduction a. What is the 21st Century Cures Act? i. The biggest health reform legislation (passed on 12/13/2016) by Congress since Obamacare and has galvanized a similarly motley crew of industries and lobbying outfitsincluding big pharma (the legislations most ardent proponent), patient advocacy groups, mental health organizations, and medical researcherswho fought for its passage over the last three years (Mukherjee, 2016). ii. Authorization of approximately $6.8 billion in funding (Mukherjee, 2016) b. Problem Statement The 21st Century Cures Act is allowing pharmaceutical companies to expedite the production of new drugs without definitively ensuring the drugs are effective and safe, which, in turn, passing the risk to the consumers. 2. Contention within the 21st Century Cures Act a. The sweeping law that seeks to speed up the approval of new drugs and invests new money in medical research continues to spark intense disagreement among patient advocates, doctors and scientists (Yasmin, 2017). b. Who are the stakeholders? i. Pharmaceutical and Medical Device Companies The law saves drug and device companies billions of dollars when it comes to bringing products to market by giving the Food and Drug Administration more discretion in the kinds of studies required to evaluate new devices and medicines for approval (Findlay, 2016). 1. The changes represent a massive lobbying effort by 58 pharmaceutical companies, 24 device companies and 26 biotech companies, according to a Kaiser Health News analysis of lobbying data compiled by the Center for Responsive Politics. The groups reported more than $192 million in lobbying expenses on the Cures Act and other legislative priorities, the analysis shows (Lupkin, 2016) ii. National Institutes of Health (NIH) – measures that will provide the agency with critical tools and resources to advance biomedical research across the spectrum from basic, curiosity-driven studies to advanced clinical trials of promising new therapies. Affecting everyone from researchers to research participants to patients suffering from numerous conditions, these measures will cut bureaucratic red tape that slows the progress of science, enhance data sharing and privacy protections for research volunteers, improve support for the next generation of biomedical researchers, exhort the NIH to extend its efforts to ensure inclusion of diverse populations, and provide the NIH with a bolus of additional funding over 10 years for key biomedical research initiatives (Hudson, 2017). iii. Medical schools, hospitals and doctors The law provides $4.8 billion over 10 years in additional funding to National Institutes of Health, the federal government’s main biomedical research organization. The funds aren’t guaranteed, however, and would be subject to annual appropriations (Findlay, 2016). 1. The money could help researchers at universities and medical centers get hundreds of millions more dollars in research grants, most of it toward research on cancer, neuroscience and genetic medicine (Findlay, 2016). 2. The bill attracted lobbying activity from more than 60 schools, 36 hospitals and several dozen groups representing physician organizations. They reported spending more than $120 million in lobbying disclosures that included the Cures Act (Findlay, 2016). iv. Advocates for mental health and substance abuse treatment The law provides $1 billion in state grants over two years to address opioid abuse and addiction. While most of that money goes to treatment facilities, some funds research (Findlay, 2016). 1. The Cures Act would also boost funding for mental health research and treatment, with hundreds of millions of dollars authorized for dozens of existing and new programs (Findlay, 2016). 2. Mental health, psychology and psychiatry groups spent $1.8 million on lobbying disclosures that included the Cures Act as an issue (Findlay, 2016). v. Patient groups Groups focused on specific diseases and patient advocacy generally supported the legislation and lobbied vigorously for it. Many of these groups get a portion of their funding from drug and device companies. The bill includes more patient input in the drug development and approval process, and if it becomes law would boost the clout of such groups (Findlay, 2016). 1. More than two dozen patient groups reported spending $6.4 million in disclosures that named the bill as one of their issues (Findlay, 2016). vi. Health information technology and software companies The law would push federal agencies and health providers nationwide to use electronic health records systems and to collect data to enhance research and treatment. Although the Cures Act wouldn’t specifically fund the effort, IT and data management companies could gain millions of dollars in new business (Findlay, 2016). 1. More than a dozen computer, software and telecom companies reported Cures Act lobbying. The groups’ total lobbying spending was $35 million on it and other legislation (Findlay, 2016). vii. Public health The Cures Act would cut $3.5 billion about 30 percent from the Prevention and Public Health Fund established under Obamacare to promote prevention of Alzheimer’s disease, hospital acquired infections, chronic illnesses and other ailments (Findlay, 2016). viii. Consumer and patient safety groups Groups like Public Citizen and the National Center for Health Research either fought the bill outright or sought substantial changes. Although they won on some points, these groups still say the Cures Act opens the door for unsafe drug and device approvals and doesn’t address rising drug costs (Findlay, 2016). ix. Medicaid patients seeking hair growth The act says Medicaid would no longer help pay for drugs that help patients restore hair. The National Alopecia Areata Foundation spent $40,000 on lobbying disclosures this cycle that included the Cures Act (Findlay, 2016). x. Food and Drug Administration The law would give FDA an additional $500 million through 2026 and more hiring power, but critics say it isn’t enough to cover the additional workload under the bill. The agency also would get something it has opposed: renewal of a controversial voucher program that rewards companies for getting drugs approved to treat rare pediatric diseases (Findlay, 2016). c. The bill opens a path for the FDA to approve new uses, or indications, for existing drugs without demanding thorough clinical tests conducted along customary lines. These include randomized samples, to prove they’re safe and effective for the new indications. Instead, the FDA could rely on “real world evidence,” which includes observations, safety and side-effect claims, and other data not subject to rigorous analysis (Hiltzik, 2016). 3. Policy Analysis a. Options: i. States should mandate clinical trials on all medications being pushed out. 1. One of the most important things about this increased use of real world evidence(RWE) is that it will expand the sources of evidence on which a pharmaceutical company can draw in the process of drug approval (MEDMEME, 2017). 2. In the past, the FDA relied largely on data gathered from clinically controlled trials to make their decisions regarding drug approval. However, authors writing in the New England Journal of Medicine (NEJM) note that with the increased use of RWE allowed by the Cures Act, other data sources can now be utilized. This can include the immense amount of data now generated from electronic health records (EHRs) and even wearable technology and mobile apps, as well as information gathered from patient billing information and entities like disease registries (MEDMEME, 2017). 3. Clinical trials take longer for the FDA to approve the drug, however, the data produces more efficient information ii. Make informed consent mandatory and/or create guidelines that will make it difficult for the informed consent to be waived. 1. Prior to the enactment of the 21st Century Cures Act, the Common Rule allowed an Institutional Review Board (IRB) to waive or alter the informed consent requirements for certain types of low-risk clinical research, but FDA regulations did not. Section 3024 of the Act modified prior FDA regulations to allow for informed consent to be waived or altered under certain conditions (Hanger, 2017). 2. Waiver or alteration is permitted for device studies if the proposed clinical testing poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the
rights, safety, and welfare of the human subject (Hanger, 2017).
3. However, without data derived from clinical trials, the real-world
evidence may not consist of efficacy data
a. Efficacy data generated through real world studies may
seem to be useful in guideline development, however,
skeptics state that build-in biases and limitations make it
problematic (Reinke, 2017).
iii. Mandate the drug industry to lower medication costs and provide pricing
and cost transparency.
1. One would expect Congress to ask the drug industry for something
in return for regulatory rollbacks like those in the Cures Act.
Remarkably, nothing in the measure would address the main
problem the public sees with the drug industry excessive prices
(Hiltzik, 2016).
4. Conclusion
a. During the drafting of the 21st Century Cures Act, lawmakers worked to identify
mechanisms that would speed up the development process of both novel drugs
and medical devices. In the signed bill, this is largely done through several new
regulations easing the approval process. To improve the clinical trial process, the
Act promotes the use of Adaptive Clinical Trials, where the end of a clinical trial
can be modified based on ongoing results such as expression of previously
defined biomarkers or reduction in tumor size. This makes the clinical trial more
flexible, saving money and time (Conway, 2017).
b. The 21st Century Cures Act, enacted into law in December 2016, seeks to speed
the FDA drug and medical device approval processes by shifting some of the
evidentiary requirements, in certain instances, from clinical trials to post-market
in other words, to the real world (Clinical Leader, 2017).
c. The 21st Century Cures Act is a huge deregulatory giveaway to the
pharmaceutical and medical device industry, papered over by new funding for
those research initiatives (Hiltzik, 2016).
d. Recommendation Mandate the FDA to utilize both Clinical Trial data along
with real world evidence as it provides a strong efficacy and lessons the risk for
the patient. Pharmaceutical companies are enthusiastic to use real world evidence
as it streamlines the approval, dispensing, and availability of the drug, which
brings in more profit. However, the priority for every stakeholder should be the
health and the consumers.
e. It remains to be seen what affect the Cures Act will actually have on drug and
medical device development, and whether it will have negative ramifications for
patient health (Conway, 2017).
References: Clinical Leader (2017). Real world evidence & the 21st century cures act what you need to know. Retrieved from https://www.clinicalleader.com/doc/real-world-evidence-the-stcentury-cures-act-what-you-need-to-know-0001 Conway, G., Lumsden, E., Todd, S. & Wolfson, B. (2017). The 21st century cures act may help solve many problems but ignores others. Retrieved from http://www.benchtobmore.com/soap/the-21st-century-cures-act-may-help-solve-manyproblems-but-ignores-others/ Findlay, S. & Lupkin, S. (2016). Winners and losers with the 21st century cures bill. Retrieved from https://www.npr.org/sections/health-shots/2016/12/02/504139105/winners-andlosers-if-21st-century-cures-bill-becomes-law Hanger, C. A. (2017). The impact of the 21st century cures act on the regulation of clinical research. Retrieved from https://www.healthlawyers.org/Members/PracticeGroups/LS/Executive%20Summaries/D ocuments/21st_Century_Cures_Act_Clinical_Research_ES.pdf Hiltzik, M. (2016). The 21st century cures act: a huge handout to the drug administration disguised as a pro-research bounty. Retrieved from http://www.latimes.com/business/hiltzik/la-fi-hiltzik-21st-century-20161205-story.html Hudson, K. (2017). The 21st century cures act a view from the NIH. Retrieved from http://www.nejm.org/doi/full/10.1056/NEJMp1615745 Lupkin, S. (2016). Legislation that would shape FDA and NIH triggers lobbying frenzy. Retrieved from https://www.npr.org/sections/healthshots/2016/11/25/503176370/legislation-that-wouldshape-fda-and-nih-triggers-lobbying-frenzy MEDMEME (2017). How the 21st century cures act will ease FDA approval. Retrieved from https://medmeme.com/how-the-cures-act-will-impact-the-pharmaceutical-industry/ Mukherjee, S. (2016). Everything you need to know about the massive health reform law that just passed congress. Retrieved from http://fortune.com/2016/12/07/congress-passes-21stcentury-cures/ Reinke, T. (2017). Real-world evidence faces some real-world challenges. Retrieved from https://www.managedcaremag.com/archives/2017/5/real-world-evidence-faces-somereal-world-challenges Yasmin, S. (2017). Is the 21st century cures act bad for your health? Retrieved from https://www.dallasnews.com/news/science-medicine/2017/05/08/21st-century-cures-actbad-heal
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