Posted: January 28th, 2025

Agenda Comparison Grid: Healthcare Agenda Dynamics from Presidential Approaches

Agenda Comparison Grid Template & Fact Sheet Sample Paper.

NURS 6050 Assignment Help:  Use this document to complete the Module 1 Assessment Agenda Comparison Grid and Fact Sheets/Talking Points Brief. This template will help write your analysis of the selected healthcare issue. Describe the administrative  agenda focus related to this issue you have selected to discuss and analyze. Administration (President Name)

Prescription Drug Prices in the United States

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Rising prescription drug costs have become a critical and multifaceted healthcare issue in the United States, significantly affecting individuals, families, and the healthcare system. This persistent challenge disproportionately impacts access to essential medications, strains personal finances, and negatively influences public health outcomes. Policymakers across various administrations have grappled with this issue, focusing on strategies to reduce patients' out-of-pocket expenses, enhance transparency in drug pricing mechanisms, and foster competition within the pharmaceutical market to ensure more affordable and equitable access to medications.

Part 1: Agenda Comparison Grid: Presidential Approaches to Prescription Drug Costs

Administration's Agenda Focus on Prescription Drug Costs	Biden Administration
Notes on Administration’s Approach	The Biden administration has prioritized reforms aimed at reducing prescription drug prices. This focus includes allowing Medicare to negotiate drug prices, capping the cost of insulin, and holding pharmaceutical companies accountable for unjustified price hikes. The Inflation Reduction Act (IRA) has introduced measures to tackle the affordability of drugs for the elderly and insured populations. For instance, the IRA allows Medicare to negotiate directly with pharmaceutical companies for specific drugs, which is expected to significantly reduce costs for older adults.
General Notes/Comments	The administration will impose a $35 monthly cap on insulin for Medicare patients and require pharmaceutical companies to provide discounts to Medicare if they increase prices beyond inflation rates. These strategies mark a proactive shift in addressing drug pricing issues.

Historical Context of Prescription Drug Pricing in the United States

The issue of rising prescription drug costs in the United States is not a recent phenomenon; it is a long-standing healthcare challenge with deep roots in the country's healthcare and pharmaceutical systems. Historically, the U.S. has consistently experienced higher drug prices compared to other industrialized nations, a trend that has been exacerbated in recent decades. This increase can be traced to various factors, including changes in pharmaceutical policies, market dynamics, and demographic shifts affecting the U.S. population's health.

Throughout the 20th century, the pharmaceutical industry in the U.S. expanded significantly, propelled by scientific innovations and government policies aimed at encouraging the discovery and development of new drugs. The Patent Act of 1984, also known as the Hatch-Waxman Act, aimed to balance pharmaceutical innovation with access to generic medications. While it favored the generics industry, it also extended patent protection for brand-name drugs, allowing pharmaceutical companies to maintain market exclusivity and higher prices for prolonged periods. This act, though landmark, inadvertently paved the way for future pricing controversies.

The surge in drug prices became especially pronounced at the turn of the 21st century, coinciding with advancements in biotechnology and the development of expensive specialty drugs for chronic and complex conditions. These specialty medications, while offering life-saving treatments, often carry exorbitant price tags, imposing significant financial burdens on patients and healthcare systems. Concurrently, overall healthcare spending in the U.S. soared, constituting an increasing share of the Gross Domestic Product (GDP). This escalation in healthcare spending heightened scrutiny on the affordability of prescription drugs as a critical component of healthcare expenses.

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Demographic and health changes have further complicated the issue of drug pricing. The aging U.S. population has led to a higher prevalence of chronic diseases, necessitating long-term pharmacological management. Additionally, the increase in comorbid conditions means that many individuals are taking multiple medications simultaneously, inflating their overall pharmaceutical expenses. These demographic shifts, combined with escalating drug prices, have created a perfect storm, making the affordability of prescription drugs an urgent concern for patients, healthcare providers, and policymakers alike.

In the political arena, prescription drug prices have emerged as a contentious issue for multiple presidential administrations, each attempting to tackle the problem with distinct approaches. From the sweeping healthcare reforms of the Obama administration to the market-focused initiatives of the Trump administration and the regulatory policies of the Biden administration, the question of drug pricing has consistently occupied a prominent position on the political agenda. These varying strategies reflect differing political ideologies and philosophies regarding the extent of government intervention in the pharmaceutical market to control prices and ensure affordability.

Agenda of the Administration on Prescription Drug Costs

The emphasis on reducing prescription drug prices has been a key objective for recent administrations due to its significant impact on healthcare affordability. For instance:

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• Biden Administration: This administration has prioritized reforms such as allowing Medicare to negotiate drug prices and limiting insulin costs. Furthermore, it holds pharmaceutical companies accountable for unwarranted price increases. The Inflation Reduction Act has introduced measures to improve affordability for the elderly and insured populations, enabling Medicare to negotiate prices for specific drugs directly, which is expected to substantially lower costs.
• Trump Administration: This administration highlighted transparency measures, requiring drug prices to be disclosed in television advertisements and limiting discounts between pharmacy benefit managers and pharmaceutical companies. The administration also introduced the "Most Favored Nation" rule, which aimed to tie U.S. drug prices to those of other developed countries. Although this rule faced legal challenges, it signified a focus on international comparisons to pressure pharmaceutical companies to lower U.S. prices. Additionally, the Trump administration advocated for policies to expedite the approval of generic and biosimilar drugs to increase competition and reduce costs.
• Obama Administration: The Obama administration supported strengthening the Affordable Care Act (ACA) to lower prescription drug prices through expanded insurance coverage, increased access to generics, and price competition. The ACA significantly broadened insurance coverage and decreased the uninsured population, thus enhancing access to prescription drugs for millions. The act also included provisions to promote the use of generics and improve transparency in drug pricing practices. Furthermore, the Obama administration pursued reforming the pharmaceutical patent system to prevent companies from delaying the market entry of generics.

Allocation of Financial and Other Resources

• Biden Administration: The IRA allocated financial resources to Medicare for implementing drug price negotiation strategies alongside funding for patient assistance programs. Specifically, the IRA provides $3.5 billion in Medicare funding for various drug-related provisions, alongside resources for patient assistance initiatives aimed at helping low-income individuals access their medications.
• Trump Administration: Budget allocations under this administration focused on regulatory reforms within the Department of Health and Human Services (HHS) and initiatives at the Food and Drug Administration (FDA) to expedite the approval of biosimilars and generics. The administration realigned resources within HHS and FDA to prioritize price-reduction initiatives and regulatory oversight of drug pricing practices.
• Obama Administration
  Resources were directed toward the establishment of competitive mechanisms for generic pricing and expanding Medicaid coverage to improve medication access among low-income populations. The Obama administration invested in programs that supported the development and uptake of generic drugs, aiming to reduce reliance on more expensive brand-name medications. Funding was also allocated to state Medicaid programs to broaden their formularies and ensure comprehensive drug coverage for beneficiaries, thereby addressing affordability at the state level.

  Notes on Administration’s Approach

  Biden’s Approach
  The Biden administration has adopted a direct interventionist approach through legislative actions like the IRA to regulate drug prices and ensure broader access. This strategy involves empowering government agencies, particularly Medicare, to directly negotiate drug prices, a measure previously prohibited. The administration’s approach is characterized by a strong emphasis on reducing out-of-pocket costs for patients, especially seniors, and holding pharmaceutical companies accountable for price increases that outpace inflation. Furthermore, the Biden administration has actively partnered with consumer advocacy groups and health economists to build public awareness and garner policy support for these reforms, recognizing the importance of public opinion and stakeholder engagement in pushing through significant healthcare legislation.

  Trump’s Approach
  In contrast, the Trump administration favored market-based solutions to reduce drug prices, emphasizing deregulation and transparency to improve pricing transparency. The focus was on fostering competition within the pharmaceutical market by streamlining the approval process for generic and biosimilar drugs, aiming to introduce more affordable alternatives to brand-name medications. The “Most Favored Nation Rule,” though legally challenged, exemplified the administration's attempt to leverage international pricing benchmarks to pressure pharmaceutical companies to lower prices in the U.S. This approach reflected a belief in market forces and reduced regulatory burdens as the primary drivers of drug price reduction, rather than direct government negotiation or price controls.

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  Obama’s Approach
  The Obama administration leveraged healthcare reform through the ACA to lower drug costs indirectly via expanded insurance coverage. By significantly reducing the number of uninsured Americans, the ACA aimed to improve access to prescription drugs for millions, as insurance coverage is a key determinant of medication affordability. The administration also focused on promoting the use of generic drugs and enhancing transparency in pharmaceutical pricing practices. The ACA included provisions designed to incentivize price competition and prevent anti-competitive practices within the pharmaceutical industry. This approach recognized the interconnectedness of insurance coverage and drug affordability, addressing the issue through broader healthcare system reforms.

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  Part 2: Fact Sheet on Prescription Drug Costs

  Significance of Addressing Prescription Drug Costs
  Addressing prescription drug affordability is of paramount significance because it directly influences the public's ability to manage chronic illnesses and acute conditions effectively. High drug prices create a substantial barrier to healthcare access, leading to delayed or forgone treatments, which can result in poorer health outcomes and increased healthcare costs in the long run (Andersen, Davidson, & Baumeister, 2018). For families, these costs can impose significant financial strain, forcing difficult choices between essential medications and other basic needs like food and housing. Moreover, the burden of high drug prices disproportionately affects vulnerable populations, including low-income individuals, racial and ethnic minorities, and those with chronic diseases, exacerbating existing healthcare disparities and undermining efforts to achieve health equity (Blendon et al., 2024). Therefore, ensuring affordable access to prescription drugs is not only a matter of individual well-being but also a critical component of a just and equitable healthcare system.

  Measures to Address the Issue

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  Medicare Drug Price Negotiation
  Granting greater negotiation power to Medicare is a pivotal measure that allows for significant price reductions, particularly for high-cost medications commonly used by seniors and individuals with disabilities (Biden Administration, 2023). This policy shift directly addresses the market power of pharmaceutical companies and leverages the collective purchasing power of Medicare to secure better prices. According to Blendon et al. (2024), Medicare negotiation has the potential to substantially lower drug expenditures for both the government and beneficiaries, making essential medications more affordable and accessible.

  Price Caps and Transparency
  Implementing price caps on life-saving drugs such as insulin and mandating price disclosures are vital steps in reducing costs and promoting transparency within the pharmaceutical market. Price caps, as seen in the Inflation Reduction Act (2022), provide immediate relief to patients facing exorbitant costs for essential medications like insulin, ensuring that these drugs remain within reach for those who need them most. Transparency measures, such as requiring drug manufacturers to disclose pricing information, empower consumers and policymakers to understand the factors driving drug costs and hold pharmaceutical companies accountable for their pricing decisions (Bisbee, Trigg, & Jain, 2022).

  Support for Biosimilars and Generics
  Expediting FDA approval processes for biosimilars and generics is crucial for lowering drug costs while maintaining quality standards. Generic drugs offer the same therapeutic benefits as their brand-name counterparts at significantly lower prices, while biosimilars provide similar cost savings for biologic medications. The FDA's efforts to streamline the approval pathway for these products encourage market competition, which is a key mechanism for driving down drug prices and increasing patient access to more affordable treatment options (FDA, 2020). By promoting the use of generics and biosimilars, healthcare systems can achieve substantial cost savings without compromising patient care.

  Barriers
  Despite the various measures implemented and proposed, several barriers continue to impede progress in reducing prescription drug costs effectively. Limited bipartisan support for more aggressive legislative measures remains a significant hurdle. Deeply entrenched political divisions and lobbying efforts by the pharmaceutical industry often hinder the passage of comprehensive drug pricing reforms that could have a more substantial impact (Ukockis, 2024). Legal challenges from pharmaceutical lobby groups, particularly concerning price negotiation authority, represent another major obstacle. Pharmaceutical companies often argue that price negotiation infringes on their patent rights and discourages innovation, leading to protracted legal battles that can delay or weaken reform efforts. Inconsistent insurance coverage of medications further complicates the issue, disproportionately affecting uninsured and underinsured populations. Even with insurance, many patients face high deductibles, co-pays, and formulary restrictions that limit their access to affordable medications, highlighting the need for more comprehensive and equitable insurance coverage (Andersen, Davidson, & Baumeister, 2018).

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  Role of Administrative Agencies
  The U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) play indispensable roles in managing programs and regulations to ensure prescription drug affordability. HHS, through its administration of Medicare and Medicaid, directly influences drug pricing and access for millions of Americans. Medicare, as the largest purchaser of prescription drugs, has significant leverage to negotiate prices, while Medicaid provides essential drug coverage for low-income populations. The FDA’s regulatory oversight of drug approvals, particularly for generics and biosimilars, is critical for fostering market competition and ensuring the availability of lower-cost alternatives. These agencies are instrumental in implementing and enforcing policies aimed at reducing drug costs and improving patient access to needed medications (FDA, 2020).

  Importance of Advocacy and Champions
  Public advocacy and influential political champions are vital in maintaining the issue of prescription drug prices on the policy agenda and driving meaningful change. Continuous public advocacy from patient groups, consumer organizations, and healthcare professionals keeps pressure on policymakers to address drug affordability. Influential political champions, such as President Joe Biden, who have prioritized legislative reforms like the IRA, are essential for pushing through significant policy changes. Consumer advocacy groups like Families USA and the National Patient Advocate Foundation play a critical role in raising awareness, mobilizing public support, and providing evidence-based policy recommendations to address prescription drug costs, ensuring that this issue remains a priority for policymakers and the public (Families USA, n.d.; National Patient Advocate Foundation, n.d.).

  Nursing Implications
  Nurses, as frontline healthcare providers, are acutely aware of the impacts of high drug costs on patient health and treatment adherence. They directly observe how financial barriers prevent patients from accessing necessary medications, leading to adverse health outcomes and increased healthcare utilization. In their multifaceted roles, nurses contribute significantly to addressing this issue in several ways. Raising awareness about legislative reforms among patients and healthcare stakeholders is a crucial function. Nurses can educate patients about available assistance programs, generic drug options, and policy changes like the IRA that aim to lower drug costs. Advocating for policies that improve access to affordable medications is another vital role for nurses. They can engage in professional advocacy, support patient advocacy groups, and communicate the patient impact of drug costs to policymakers. Participating in research and data collection to highlight how drug costs affect patient outcomes is also essential. Nurses can contribute to the evidence base by documenting the consequences of medication non-adherence due to cost and by participating in studies that evaluate the effectiveness of interventions aimed at improving drug affordability. Through actively engaging in these areas, nurses play a critical role in mitigating the adverse effects of high prescription drug prices on patient health and promoting equitable access to care.

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• References
  • Andersen, R., Davidson, P., & Baumeister, S. E. (2018). Improving Access to Care in America. Changing the US Health Care System: Key Issues in Policy and Management. Jossey-Bass.
  • Bisbee, G., Trigg, D., & Jain, S. (2022). The New Health Economy: Ground Rules for Leaders. Georgetown University Press.
  • Blendon, R. J., Blumenthal, D., Glied, S., Sommers, B. D., & Dusetzina, S. B. (2024). Critical health care challenges for the next US President. New England Journal of Medicine, 391(15), e36.
  • Families USA. (n.d.). Issue: Prescription drugs. Retrieved from https://familiesusa.org/issue/prescription-drugs/
  • FDA. (2020). Biosimilar and generic drugs: What’s the difference? U.S. Food and Drug Administration.
  • Inflation Reduction Act of 2022. H.R.5376, 117th Congress.
  • National Patient Advocate Foundation. (n.d.). Prescription drugs. Retrieved from https://www.patientadvocate.org/explore-our-resources/prescription-drugs/
  • Ukockis, G. (2024). The Opioid Crisis: A Policy Case Study. Oxford University Press

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