Understanding Claims Data

Claims Data

• Claims data generally consists of medical claims, prescription claims, and enrollment databases.
• A unique member identifier is needed to link information from different databases for comprehensive research using claims data.
• Enrollment databases contain information about patients' insurance coverage at any given time.
• Medical claims databases include information about patients' hospital claims.
• Prescription claims databases do not contain information about outpatient claims, drug side effects or insurance coverage.
• Advantages of using claims data include ease and cost-effectiveness of data collection, long follow-up times, and the potential for generalization of results.
• A disadvantage of using claims data is that the data was not initially collected for research purposes.
• Claims data can be used for utilization studies, adverse event studies, comparative effectiveness studies, and health policy research.
• In claims study designs, the index date typically refers to the date of a specific event, such as the first diagnosis or a prescription date.
• Claims data is not a good resource for studying patients’ subjective measures of pain, like pain scales.

Medication Use and Safety

• Medication Use Process refers to the complete network of interactions in prescribing and dispensing medication, monitoring its use, and following up after administration.
• The accreditation process of a healthcare institution by the Joint Commission is voluntary.
• Lean focuses on the value of a particular process.
• Voluntary incident reporting systems do not reflect the complete total number of occurrences at an institution.
• Failure Mode Effects Analysis (FMEA) is a prediction tool, unlike root cause analysis.
• A medication error is a preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of a healthcare professional, patient, or consumer.
• Prior to the 1990s, a punitive patient safety culture was in place in most medical organizations.
• Tall Man lettering is exemplified by the use of hydrALAZINE and hydrOXYzine.
• PDSA stands for Plan, Do, Study, Act.
• The Agency for Healthcare Research and Quality (AHRQ) aims to make healthcare safer, more equitable, affordable, accessible, and of higher quality.

Health Economics

• Perfect competition as a market structure is characterized by a perfectly elastic demand curve.
• Healthcare can be insured because the need for services can be predicted with some certainty for large groups of patients.
• Longer patent exclusivity for pharmaceutical companies would most likely increase healthcare costs.
• Moral hazard refers to overconsumption of healthcare services that occurs when people change their behavior because they have health insurance.
• Perfect competition is characterized by many buyers and sellers.
• By acting as a patient’s agent, physicians can create supplier-induced demand.
• Health care services are usually less standardized than goods and services in other markets.
• The availability of health insurance creates patient-induced demand.
• Universal demand refers to virtually everyone using healthcare services.
• The government should not support the creation of monopolies in the Pharma industry.

Department of Health and Human Services (HHS) Operating Divisions

• There are 13 operating divisions of the Department of Health and Human Services (HHS).
• 11 operating divisions are under the Office of the Secretary (OS).
• 2 staff divisions are still often counted toward the 13 HHS divisions
• Public Health Service Agencies (8):
• CDC is responsible for public health surveillance and outbreak control
• FDA ensures safety of drugs, food, and medical devices
• NIH conducts biomedical and public health research
• HRSA funds care in underserved rural and urban areas
• SAMHSA provides services for substance use & mental health
• AHRQ researches healthcare quality and safety
• IHS is the Indian Health Service
• ATSDR deals with toxic substances and environmental health
• Human Services Agencies (3):
• ACL is the Administration for Community Living (aging & disability)
• ACF is the Administration for Children & Families (child welfare, TANF)
• CMS is the Centers for Medicare & Medicaid Services
• Department-wide (2):
• OIG is the Office of Inspector General, responsible for fraud & abuse investigations
• OCR is the Office for Civil Rights, enforces HIPAA & nondiscrimination like Section 1557

National Institutes of Health (NIH)

• The NIH's purpose is biomedical and public health research.
• NIH's mission is to seek fundamental knowledge about living systems and apply that knowledge to enhance health, lengthen life, and reduce illness and disability.
• NIH is the world’s largest source of biomedical research funding.
• It includes 27 separate institutes and centers, such as NCI (cancer), NIAID (infectious diseases), and NIMH (mental health).
• NIH leads research on cancer, Alzheimer’s, and vaccines including partnered in development of COVID-19 vaccines.

Food and Drug Administration (FDA)

• FDA's purpose is to protect public health by ensuring safety, efficacy, and security of drugs, biologics, medical devices, and food supply.
• FDA's mission is to regulate and supervise food safety, tobacco products, dietary supplements, prescription and over-the-counter drugs, vaccines, biopharmaceuticals, blood transfusions, medical devices, cosmetics, and animal foods.
• FDA approves new medications and medical devices.
• It regulates product labeling and advertising.
• The FDA approved Pfizer and Moderna COVID-19 vaccines under Emergency Use Authorization.

Centers for Disease Control and Prevention (CDC)

• The CDC's purpose is disease prevention and control, health promotion, and preparedness.
• The CDC’s mission is to protect America from health, safety, and security threats—both foreign and domestic.
• The CDC tracks disease outbreaks, such as flu and COVID-19.
• It issues clinical and public health guidelines.
• The CDC operates the National Center for Health Statistics.
• The CDC led the national COVID-19 response surveillance and issued guidance on masking and vaccination.

Centers for Medicare & Medicaid Services (CMS)

• CMS administers the nation’s major healthcare programs.
• These programs include Medicare for seniors and certain disabled individuals.
• Medicaid is for low-income individuals, and is a joint state-federal program.
• CHIP is the Children’s Health Insurance Program.
• CMS provides Marketplace oversight under the Affordable Care Act.
• CMS manages Medicare reimbursement rules and Medicaid waivers.

Health Resources and Services Administration (HRSA)

• HRSA's purpose is to improve access to health care services for people who are uninsured, isolated, or medically vulnerable.
• Programs include Community Health Centers.
• The National Health Service Corps places health providers in shortage areas.
• HRSA is responsible for rural health initiatives.
• HRSA funds Federally Qualified Health Centers (FQHCs) and supports maternal health programs.

Agency for Healthcare Research and Quality (AHRQ)

• AHRQ produces evidence to make health care safer, higher quality, more accessible, equitable, and affordable.
• AHRQ develops tools for health systems and clinicians.
• It funds research on improving care delivery and outcomes.
• AHRQ created tools for reducing hospital readmissions and measuring patient satisfaction, such as CAHPS surveys.

Substance Abuse and Mental Health Services Administration (SAMHSA)

• SAMHSA's purpose is to improve access to and quality of substance use and mental health services.
• Its mission is to reduce the impact of substance abuse and mental illness on America’s communities.
• SAMHSA distributes block grants to states.
• It develops national behavioral health strategies.
• SAMHSA leads national efforts in opioid crisis response and suicide prevention.

Indian Health Service (IHS)

• The IHS provides direct health care to American Indian and Alaska Native people.
• It operates hospitals, clinics, and health stations across tribal regions.
• Key Programs are chronic disease management, like diabetes, and maternal and child health.
• IHS provides culturally competent care for over 2.5 million tribal members.

Administration for Community Living (ACL)

• The ACL supports older adults and people with disabilities to live independently.
• It combines the Administration on Aging (AoA) and the Administration on Intellectual and Developmental Disabilities.
• Programs include Meals on Wheels and elder abuse prevention.
• The ACL oversees funding for aging and disability resource centers.

Agency for Toxic Substances and Disease Registry (ATSDR)

• ATSDR's purpose is to prevent exposure to hazardous substances and reduce related health effects.
• Its mission is to protect communities from harmful health effects related to exposure to natural and man-made hazardous substances.
• ATSDR investigates chemical spills, Superfund sites, and environmental health risks.

Administration for Children and Families (ACF)

• ACF promotes the economic and social well-being of families, children, individuals, and communities.
• Programs include Head Start & Early Head Start.
• TANF is Temporary Assistance for Needy Families.
• ACF provides child welfare and adoption services and refugee resettlement.
• ACF supports early childhood development programs and family assistance grants.

Office for Civil Rights (OCR)

• The OCR enforces HIPAA and civil rights protections in health care settings, including Section 1557 of the ACA.
• The Office for Civil Rights (OCR) enforces that discrimination on the basis of gender identity, sex stereotyping, and sexual orientation is prohibited in any federally funded health program.

Office of Inspector General (OIG)

• The OIG conducts audits, investigations, and inspections to combat fraud and abuse in HHS programs.

Health Policy Issues in Women's Health

• Significant and persistent issues continue to disproportionately affect women across various populations.
• These challenges are often compounded by socioeconomic status, race, geography, and political environment.
• Key challenges:
• Reproductive Health Access, which varies widely by state.
• Maternal Mortality and Morbidity, where in the U.S. has the highest rate among developed countries and has disparities affecting Black and Native American women being 2–3 times more likely to die from pregnancy-related causes.
• Medicaid Gaps & Coverage Instability, where women in non-expansion states often fall into the “coverage gap".
• Gender Bias in Research, in which historically, women were underrepresented in clinical trials, and some diagnostic and treatment protocols still rely on male-centric data.
• Economic Burden & Out-of-Pocket Costs, because women incur higher costs due to reproductive care, mental health needs, and longer lifespans.

Reproductive Health Access

• Access to contraception, abortion, and comprehensive reproductive care remains a politically and geographically divided issue.
• In many states, restrictive laws have emerged following the overturning of Roe v. Wade.
• The Hyde Amendment prevents federal funds from being used for abortion, affecting low-income individuals relying on Medicaid.
• Post-Dobbs v. Jackson ruling has led to bans and restrictions in many states, worsening disparities.
• Federal funding (like Medicaid) still cannot be used for most abortions due to the Hyde Amendment.
• Insurance coverage does not guarantee proximity or availability of reproductive providers.

Maternal Mortality

• The United States ranks poorly in maternal health outcomes compared to other high-income countries.
• Black women are nearly three times more likely to die during childbirth than white women. Black and Native American women are 2–3 times more likely to die from pregnancy-related causes due to structural racism and lack of access to quality care.
• This is due in part to systemic racism, implicit bias in clinical settings, lack of access to prenatal and postpartum care, and chronic stress from socio-economic inequities.

Coverage Gaps

• Women in non-expansion states often fall into the “coverage gap,” earning too much to qualify for Medicaid but too little for ACA subsidies.
• Even those with insurance may lack access to providers due to shortages of OB/GYNs.
• In states that have not expanded Medicaid under the ACA, many women fall into a gap where they earn too much to qualify for Medicaid but too little to afford private insurance.
• This leaves them uninsured and vulnerable to high out-of-pocket costs.

Out-of-Pocket Costs

• Women face disproportionately higher health care costs related to reproductive services, gender-specific conditions, and prescription drug needs.
• They are more likely to delay or forgo care due to affordability.
• This includes expenses tied to pregnancy, birth control, mammograms, Pap smears, and more.

Research Representation

• Historically, medical research has underrepresented women.
• Some diagnostic and treatment protocols still rely on male-centric data.
• This results in a lack of sex-specific data and limited understanding of how diseases and treatments affect women differently.
• Ongoing advocacy pushes for the inclusion of women in all phases of clinical trials.

Race, Inequality, and Health

Health Care Disparities

• Health care disparities are systematic, measurable differences in health outcomes and access to health care that exist among different population groups.
• Health care disparities are preventable differences in access to health care, outcomes, and health status experienced by socially disadvantaged populations.
• These differences are linked to social determinants of health such as income, education, housing, discrimination, and geographic location.
• Differences are shaped by factors like:
• Race/ethnicity
• Income
• Geography
• Disability
• Language barriers
• Gender identity/sexual orientation
• Groups most affected include racial and ethnic minorities, low-income individuals, people with disabilities, and rural communities.

Importance of Addressing Health Care Disparities

• Health disparities lead to worse health outcomes for vulnerable populations.
• Disparities result in worse health outcomes, higher rates of chronic conditions, and preventable deaths.
• This contributes to higher rates of chronic disease, infant and maternal mortality, and premature death.
• COVID-19 exposed how deeply inequities are embedded in the health system.
• Reducing disparities improves the overall health of the population.
• Inequities increase health care costs due to preventable hospitalizations, emergency visits, and untreated conditions.
• Poor health outcomes increase health care costs, reduce workforce productivity, and strain public resources.
• Closing disparities could save the U.S. billions annually.
• Addressing disparities can lead to improved productivity, lower costs, and more sustainable systems.
• Equal access to quality health care is a human right.
• Ethical and Social Justice Imperative:
• Equal access to quality care is a fundamental principle of justice.
• Addressing disparities aligns with human rights and democratic values.
• Reducing disparities is essential for promoting fairness, social justice, and equal opportunity.
• The pandemic disproportionately affected communities of color due to structural inequities in access to testing, vaccines, employment protections, and health services.
• These lessons reinforce the urgency of addressing systemic barriers.

LGBTQ+ Health Policy

• Section 1557 of the ACA prohibits discrimination in federally funded health programs based on race, color, national origin, sex, age, or disability.
• "Sex" includes sexual orientation and gender identity, ensuring inclusive treatment in health care facilities and access to gender-affirming care.
• Section 1557 of the Affordable Care Act prohibits discrimination based on sex, which the Biden administration interprets to include gender identity and sexual orientation.
• This rule applies to all health programs receiving federal funding.
• Obama expanded protections
• Trump narrowed them
• Biden restored and extended them
• LGBTQ+ individuals gained broader access to employer-sponsored health benefits and spousal insurance coverage after the Supreme Court's 2015 ruling legalizing same-sex marriage nationwide. Legalization allowed same-sex couples to access spousal benefits, such as:
• Employer-sponsored dependent coverage
• Family leave
• Hospital visitation rights
• States diverge significantly in how they address LGBTQ+ health.
• Some states explicitly cover gender-affirming surgery and hormone therapy, while others restrict it, especially for minors
• Some offer Medicaid coverage for gender-affirming procedures.
• Others have passed legislation restricting access for transgender youth, particularly related to hormone therapy and mental health support.
• LGBTQ+ individuals experience higher rates of anxiety, depression, and suicidal ideation due to minority stress and social stigma.
• LGBTQ+ people face higher rates of depression, anxiety, and suicide due to discrimination.
• Recent federal guidance has emphasized training health professionals in culturally competent, LGBTQ-inclusive care.
• Federal support has grown for inclusive mental health care models.
• Recent Examples of How Policymaking Addresses LGBTQ+ People’s Health:
• Section 1557 of the Affordable Care Act:
• Marriage Equality:
• State Medicaid & Gender-Affirming Care:
• Mental Health Protections:

The Role of Public Opinion Polls in Health Policy

Benefits

• Public opinion influences lawmakers, shaping the legislative agenda and catalyzing action on key health issues.
• Advocates and political actors use polls to understand how different messages resonate with voters.
• Public feedback helps fine-tune policy proposals.
• Usefulness:
• Agenda-Setting: Elected officials respond to what matters to voters. Framing Debates: Polls help identify what language or framing resonates with the public.
• Real-World Impact: KFF polling showed public support for Medicare drug price negotiation, helping pass the Inflation Reduction Act.

Limitations

• Poorly worded or leading questions can produce misleading results.
• Health crises, media coverage, and partisanship can rapidly alter public attitudes.
• This makes polling snapshots sometimes unreliable for long-term planning.
• Volatility: Opinions shift based on news coverage, misinformation, and political rhetoric.
• Question Wording Bias: Poorly designed polls can misrepresent actual sentiment.
• Lack of Depth: They show what people think, but not always why.

Congress, the Executive Branch, and Health Policy

Federal Government Programs with a Role in Health Care

• Medicare provides health coverage to over 65 million seniors and individuals with disabilities. Federal insurance for those 65+ and disabled individuals.
• Medicaid and CHIP serve low-income families, children, and individuals with disabilities, jointly funded by federal and state governments. Joint federal-state program for low-income populations.
• Veterans Affairs (VA) Health System delivers health care through VA hospitals and clinics to eligible military veterans. Serves U.S. veterans with its own hospitals and clinics.
• TRICARE offers health insurance for active-duty military, retirees, and their dependents.
• Covers military service members, retirees, and their families.
• ACA Marketplaces are federally and state-run platforms that allow individuals to purchase subsidized private insurance under the Affordable Care Act.
• Subsidized private insurance plans regulated by the federal government.

Roles of Each Branch of Government

• The Legislative Branch (Congress) drafts and enacts legislation, such as the ACA, IRA, and drug pricing reforms.
• Passes laws like the Affordable Care Act, IRA, etc.
• Allocates funding for HHS, CMS, and public health programs.
• The Executive Branch implements health laws and regulations through departments like HHS, and sub-agencies such as CMS, FDA, and CDC.
• Implements laws through agencies like HHS, FDA, CDC, CMS.
• Issues executive orders and regulations (e.g., defining Section 1557 protections).
• The Judicial Branch interprets the constitutionality and application of health laws, including rulings on Medicaid expansion, contraception coverage, and nondiscrimination clauses.
• Interprets constitutionality of laws (e.g., NFIB v. Sebelius upheld ACA).
• Can block or uphold enforcement of federal health regulations.

Health and Human Services (HHS) Divisions

• NIH, FDA, CDC, CMS, HRSA, AHRQ, SAMHSA, IHS, ACL, ACF, ATSDR, OCR, and OIG each have a unique role in national health oversight, funding, and regulation.

Federal Budget Process

• Agencies such as HHS submit requests in the Presidential Budget Proposal, which are compiled and released by the Office of Management and Budget.
• Includes HHS funding needs for CDC, NIH, Medicaid, etc.
• Congress reviews and drafts budget resolutions setting overall limits for spending and revenue.
• House and Senate Budget Committees create a framework.
• 12 subcommittees divide discretionary spending in the Appropriations Process.
  • House and Senate must pass appropriations bills.
• 12 subcommittees (e.g., Labor-HHS) set detailed amounts.
• Health agencies like NIH, CDC, and SAMHSA receive their annual funding through these bills.
• The House and Senate pass appropriations bills, often after negotiation and amendment in Congressional Voting.
• The President signs the bills into law, finalizing the budget in Final Approval.

Key Concepts

• Mandatory Spending includes programs like Medicare, Medicaid, and Social Security. Additional Notes:
• Mandatory spending includes Medicare, Medicaid.
• Discretionary Spending funds public health infrastructure, research, and workforce training.
• Discretionary spending includes CDC, NIH, SAMHSA, etc.
• Budget Delays & Government Shutdowns impact the ability of agencies to function and delay critical health initiatives.
• Delays or cuts can reduce public health response capacity.

The Inflation Reduction Act (IRA)

• The IRA grants Medicare unprecedented power to negotiate prices for high-cost prescription drugs, starting with a small list and expanding over time.
• For the first time, Medicare can negotiate prices of high-cost drugs (starting 2026 for 10 drugs).
• Drug manufacturers must reimburse Medicare if their prices rise faster than inflation, creating downward pressure on future price hikes.
• Drug makers must pay penalties if they raise prices faster than inflation.
• Medicare Part D enrollees will pay no more than $2,000 per year for prescription medications, starting in 2025.
• Starting in 2025, annual out-of-pocket prescription costs for Medicare Part D will be capped at $2,000.
• Insulin is capped at $35/month for Medicare recipients.
• Monthly insulin costs are capped at $35 for Medicare beneficiaries.
• It enjoys broad public support but faces legal opposition from pharmaceutical companies.
• Expected to lower costs for seniors and increase federal regulation of drug prices.
• The IRA represents the most sweeping drug pricing reform since Medicare Part D.
• Its implementation will likely be a central issue in the 2024 election cycle.

Section 1557 of the Affordable Care Act

• It applies to all federally funded health programs and insurers.
• It bars discrimination based on race, color, national origin, sex (interpreted to include sexual orientation and gender identity), age, and disability.
• It was initially expanded under Obama, then narrowed under Trump to exclude transgender protections, and later re-expanded by Biden's administration.
• It forms the foundation for gender-inclusive policies in hospitals, clinics, and insurance plans.
• This provision bars discrimination on the basis of gender identity, sex stereotyping, and sexual orientation is prohibited in any federally funded health program.
• It mirrors Title IX and Title VI frameworks by embedding civil rights principles into health care law.