Download HMGT 3310 - Final Exam Review: History and Regulation of Food and Drugs and more Exams Advanced Education in PDF only on Docsity!
HMGT 3310 - Final Exam (chapters 5-8, ACA) Latest Update!!
Common Rule - name used for the Federal Policy for the
Protection of Human Subjects
issues related to drug/health product regulation - Answer - safety and efficacy
- oversight pre and post market
- intellectual property rights
- access to medication
history of regulations - Answer Imports Drug Act of 1848 --> formation of USDA Bureau of Chemistry in 1862 --> Biologics Control Act of 1902 --> Pure Food and Drug Act of 1906 --> Shirley Amendment of 1912 --> Harrison Narcotics Tax Act of 1914 --> FDA formation in 1930 --> Food, Drug, and Cosmetic Act of 1938 --> Wheeler-Lea Act --> Required PTO Filing in 1962
Imports Drug Act (1848) - Answer - restrict importation of foreign drugs
- adulterated/adulterated drugs: inspections/destruction/detention/exportation of substandard drugs
USDA Bureau of Chemistry (1862) - Answer - inquiry into the safety of food, drugs, and animal feed at the federal level
Biologics Control Act (1902) - Answer - due to faulty production of diphtheria vaccine, first federal law to regulate a pharmaceutical product
- licensing procedures established for the manufacture and distribution of vaccines
- allowed government officials to inspect laboratories and factories
Pure Food and Drug Act (1906) - Answer - in reaction to Upton Sinclair's novel "The
Jungle" depicting unsafe and unsanitary conditions in the meat packing industry
- broad proscription against "adulteration and misbranding of foods and drugs in interstate commerce
Shirley Amendment (1912) - Answer - outlawed false therapeutic claims that were deliberately designed to deceive the consumer
Harrison Narcotics Tax Act (1914) - required prescriptions before patients could obtain products containing more than minimal amounts of narcotic substances
- required physicians and pharmacists to maintain records of prescriptions issued and dispensed
FDA formation (1930) - set standards for packaging of most canned foods
Food, Drug, and Cosmetic Act (1938) - response to toxic antibiotics that killed 107 children
- established the basic regulatory structure that controls pharmaceuticals today
- procedures for review of the safety of new drugs before they came to market
- extension of the FDA's scope of authority to include cosmetics and therapeutic devices
- elimination of the requirement that the government prove fraud to prosecute false claims
- new authority for the FDA to inspect factories and to obtain court injunctions against the distribution of unsafe or adulterated products
- expansion of FDA standard-setting authority for quality and packaging of food
Wheeler-Lea Act - Answer - authorized the Federal Trade Commission (FTC) to regulate advertising of products subject to FDA oversight other than prescription drugs
Mandated PTO Filings 1962 - Answer - Kefauver-Harris Amendments: response to thalidomide babies, shift from safety to efficacy, retroactive review of 24 years, rejected FDA 60 day review requirement
Orphan Drug Act (1983) - Answer - orphan drugs = drugs targeted for diseases with less than 200,000 patients
- manufacturing incentives: +7 years of market exclusivity, authorization of tax credits and grants
Prescription Drug Marketing Act of 1987 + 1990 amendment - Answer - labeling and marketing rules
- restricted the distribution of drugs beyond conventional retail sale
banned diversion from legitimate channels, prohibits sale of samples, restricts foreign reimportation
- required that all food packages include nutrition information, and it standardized the use of labeling terms with health implications
Medical Device Act (1990) - Answer - reporting requirements to FDA post market from hospitals and nursing homes
- new authority to order recalls
Dietary Supplement Health and Education Act (DSHEA) Answer herbal remedies sold as dietary supplements are more like foods than like drugs more stringent than foods, less rigorous than drugs no requirement for premarket testing and approval allowed to advertise claims that their products improve health and strengthen the body against illness, but not that they treat a specific disease
Prescription Drug User Fee Act (PDUFA, 1992) - Answer - faster new drug reviews
- added more reviewers to its staff with funds raised from user fees levied on applicants
Food and Drug Administration Modernization Act (FDAMA, 1997) - Answer - speeded up the review of medical devices by putting them on a par with drugs
- made significant amendments to the monitoring of pharmaceutical marketing off-label uses increasingly permitted direct-to-consumer advertising, clinical trials accessible through a public registry fast-tracking of regulatory approval incentives for drug testing in children
Medicare Prescription Drug Improvement and Modernization Act of 2003 (MMA) Answer
- coverage involves multiple restrictions significant copayments and deductibles, but it will increase access for millions of elderly patients
2000 Medicine Equity and Drug Safety Act - Answer - reimportation of drugs
- resisted by FDA because of their lack of control over safety
340B Drug Program - Answer - pharmaceutical manufacturers to enter into an agreement called a pharmaceutical pricing agreement with the HHS Secretary
- under the PPA, the manufacturer agrees to provide front-end discounts on covered outpatient drugs purchased by specified providers, called "covered entities," that serve the nation's most vulnerable patient populations
- the purpose of the 340B program is to enable covered entities "to stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services
Drug Enforcement Administration (DEA) regulatory function - Answer - non-FDA narcotics
Food and Drug Administration (FDA) regulatory function Answer regulatory influence over 25% of the national economy
U.S. Department of Agriculture (USDA) regulatory function Answer food supply
Federal Trade Commission (FTC) regulatory function Answer advertising non-drug or device healthcare products
Environmental Protection Agency (EPA) regulatory function Answer drinking water non-bottled and pesticides
states regulatory function Answer oversees prescribing behavior and alcohol sales
first permanent state health board established in? - Answer - Massachusetts, 1869
earliest federal role in public health regulation - Answer - decision to centralize the administration of marine hospitals under a supervising surgeon general of the Marine Hospital Service in 1870
state health departments grew in response to? - Answer - emergence of the germ theory of disease
Public Health Service (PHS) - Answer - given power to investigate the spread of diseased, including the involvement of sanitation, sewage and pollution in lakes/streams
- health screening immigration
- Office of the Surgeon General + Bureau for State Support + Bureau for Medical Services + Indian Health Services
first vaccination - Answer - 1796, smallpox
of health departments at present - Answer - 3000+
World War I - Answer - attention focused on venereal disease and sex education
epidemiology - Answer - tracks national disease outbreaks
Corps of Public Health Professionals - Answer - Marine Hospital Service personnel
USDA's regulatory and inspection roles - Answer - response to Upton Sinclair's "The Jungle", which exposed unsanitary and dangerous conditions in meatpacking industry
- empowered by the Pure Food and Drug Act and the Meat Inspection Act
- nutrition: first dietary recommendations based on five food groups, followed by a recommendation for including iodine in salt in 1924
first worldwide public health initiative - Answer - Malaria Control in War Areas program, later the CDC (Communicable Disease Center, later the Center for Disease Control)
Health Resources and Services Administration (HRSA) - Answer - Tracks the nation's health care workforce supply of physicians, nurses, and other health professionals.
National Institutes of Health (NIH) - Answer - Funded medical research around the country.
1960s emergence of chronic diseases - Answer - such as: cancer, neurological disorders and diabetes that result in the progressive deterioration of physiological function
- realization that environmental exposures may result in such deadly degenerative diseases.
- direct relationship between cigarette smoking and lung cancer
- CDC: the Epidemiology Branch responsible for following outbreaks of infectious diseases, was expanded into chronic diseases research
- food labeling: food safety and nutrition programs began to put more emphasis on controlling the risk of long-term diseases-heart disease, cancer, as well as other diseases connected with a diet high in fat and obesity
creation of the EPA in 1970 - Answer - sought to limit public exposures to environmental hazards that pose long-term health risks
- Clean Air Act = discharge standards were set for emissions into the air from smokestacks, automobiles, and other sources
- Clean Water Act = set discharge standards for emissions into streams and other waterways
- National Environmental Protections Act = mandated "environmental impact assessments" of all new government projects to balance predicted benefits against possible harm to the environment
5 Social Determinants of Health - Answer increase survival rates more than anything else; greatly affect longevity and healthiness of life
- social and community context --> education --> economic stability --> neighborhood and built environment --> health and health care
US health and social spending-health = 16%
social (public programs) = 9%
life expectancy = 78.8 years
-relationship: higher life expectancy derived from increased social funding and decreased healthcare funding
Discuss the positives and negatives of the three sectors (state, federal, private sector) regulating and overseeing public health interests. - Answer - state: closer regulation, more adapted to circumstance and directly meets needs of the local population, but lack of standardization
- federal: too broad (not adaptable), but increases standardization, too far removed to detect lapses
- private: specific agencies can monitor specific aspects of regulation to ensure more detailed expert regulation, but might conflict with public government standards
Discuss the benefits and detriments of focusing on public health vs. individual health. - Answer - public health = aggregate health of populations
- large-scale prevention measures detracts from those who are already ill
- costs less to implement larger prevention programs than pay for individuals' medical treatment
most vulnerable populations are often the ones not reached by public health programs
Discuss the policy implications of putting resources toward preventing and treating chronic disease vs. acute disease/injuries. - Answer - causes of acute conditions are clear, while causes for chronic ones are not --> more research dollars funneled to overcoming chronic disease
- environmental concerns --> limitations on exposure, implementing cleanups of toxic waste sites and workplaces
Tuberculosis: Behavioral controls for protecting public health vs. individual liberty - Answer
Discuss the differences between community health and population health. - Answer - community health = collective efforts of individuals and organizations who work to promote health within a geographically or culturally defined group
- population health = outcome-driven approach to "manage" health for a specific group of individuals, typically defined by attribution
Discuss the findings of the Commonwealth: more social funding and less healthcare funding = longer life expectancy. Why? Could it work here? How? - Answer - social funding = public health = preventative measures, less costly per capita and more widely utilized
- focus on environmental factors to treat the population as a whole --> better outcomes overall
4 areas of regulation - Answer - antitrust
- referral restrictions
- tax-exempt status
- data privacy
Four Horsemen of the Healthcare Economic Apocalypse - Answer - moral hazard through 3rd party reimbursement
- learned intermediaries (intercession of physicians as agents for the consumer)
- asymmetry of information (knowledge gap between patients and physicians)
- limited price elasticity of demand due to the life and death nature of the services
American healthcare industry - Answer - 1/6 of GDP
- promulgated by CMS, enforced by OIG
False Claims Act 1863 Answer if underlying business relationship fraudulent, then every bill/claim submitted to the government is fraudulent even if handled correctly originally passed for fraud occurring during Civil War, not for health care violation may be either civil or criminal, depending upon intent/knowledge includes medical necessity, lying about or failing to report mistakes made and failing to meet the standard of care
kickbacks - Answer - gifts given by suppliers to purchasing agents for the purpose of influencing their choice of suppliers
- intent to get referrals
- exceptions: safe-harbors, as deemed by government
Stark amendments - Answer - regarding self-referrals
- non-criminal, just civil fines/penalties or exclusion from Medicare program
- over utilization
- profits cannot flow directly to the referrer in relation to volume of patients
- requires knowledge of ownership of healthcare entities
-entire purpose is to keep costs down by avoiding internal manipulations of price in referrals of services
Qui Tam - Answer - whistleblowers
-high risk, high reward/bounty
????ax-exemption status - Answer - charities for indigent patients --> proliferation of taxable and tax-exempt hospitals
-must demonstrate a community benefit (healthcare is NOT an inherent community benefit; must prove beyond)
-enforced by IRS
- must be said and done in charitable mission and proven numerically
- tax v. tax-exempt: governance does not impact quality of care
non-profit hospitals - Answer - most American hospitals continue to function on a nonprofit basis and so are exempt from most taxes and can accept tax-deductible donations
- non profits: no shareholders, utilize profits as retained earnings internally with in the company, get exemption for taxes separatlely does not fall under automatic exemptions
data privacy - Answer - rights of consumer as a part of civil right
- HIPAA: placed significant new restrictions on handling and transmission of all patient information that is maintained in electronic form; access and copies of records shall be made available to the patient
- care provision, healthcare administration, claims payment, research
- security (restricts access via breach, more technological application) v. privacy (rules for holding confidentiality; consent and control)
- enforced by the Office of Civil Rights, prosecutable by DOJ
- PHIA = individual identifiers regarding health information (determines extent to which information about an individual can be publicized, because some factors are more revealing than others)
- mistakes less costly than intentional lapses/breaches
Why are kickbacks allowed in other industries but not in healthcare? - Answer - moral hazard + asymmetry of information = reason why referrals are illegal in healthcare industry but okay in other industries, such as real estate
Antitrust impact on Q, A and C? - Answer - competition --> less costly
- more accessibility (more suppliers in the market)
- break up monopolies --> more competition --> ensures higher quality
Safe Harbors for Stark and F&A enough? Appropriate? What would happen if the restrictions were lessened? - Answer - yes they are appropriate, but may not be enough.
-If restrictions were lessened, then there would be even more healthcare fraud and abuse ("literal" enforcement allows for more loopholes)
- composed of 27 separate institutes and centers (ICs) that conduct and coordinate research across different disciplines of biomedical science
- large research budgetary increases in the past few decades
patient harm in research - Answer - exploiting disadvantaged populations without benefit to them
- experimenting on people without their knowledge
- dangerous research
- violation of privacy
patient protections in research - Answer - ethical guidelines: Belmont Report Declaration of Helsinki (established the principle of respect for the individual autonomy of subjects as the philosophical justification for carrying out ethical research; subjects must provide "informed consent"), Council for International Organizations of Medical Sciences, International Ethical Guidelines for Biomedical Research Involving Human Subjects
regulations: Regulations for the Protection of Human Subjects, HIPAA Regulations for Standards for Privacy of Individually Identifiable Health Information, HHS Regulations for Responsibility of Applicants for Promoting Objectivity in Research
IRB (Institutional Review Board) Answer oversee protection of human subjects in research at each organization receiving federal funding
review research protocols before they are initiated and monitor studies on an ongoing basis
Objective participants, scientific or specialty background, continual oversight
Ensure research is scientifically valid, subjects are safe and have a thorough understanding of what they are consenting to, subject privacy, and provide reports to central agencies to ensure they are meeting all requirements
Review proposed protocols of local investigators with a mandate to minimize the risks to subjects consistent with maintaining sound research designs
balance potential harm to subjects against potential benefits of new knowledge that may be gained
Who should decide how to spend research dollars -politicians? public advocates? scientists? WHY? - Answer - mix of all objective individuals
- policy makers + scientists + researchers + economic analyses
Bench research vs. applied research funding - best methods? - Answer - bench = basic = studies basic scientific principles behind; shorter term; foundation for applied
- applied = takes basic research to make new tools; long-term impact
Institutional Review Boards and the "Dark Side" of research - are IRBs enough? - Answer - at risk of patient safety
IRBS sole purpose is to ensure safety of research subjects through full awareness and clear consent
Balance of individual rights and societal benefit - are we handling this well? Answer - IRBs need to be more aggressive in informing subjects of research to their rights, but have definitely improved since the mid 20th century
current ACA - Answer - American Health Care Act if 2017 - would have repealed the individual mandate and the employer mandate, dramatically cut Medicaid spending and eligibility, eliminated tax credits for healthcare costs, abolished some taxes on high earners, and altered rules concerning pre-existing conditions and essential health benefits)
- The Better Care Reconciliation Act of 2017 (2nd attempt, tax changes)
- The "Thumbs Down" - July 28, 2017 (John McCain's deciding vote in NOT repealing the individual mandate and other ACA provisions)
individual mandate (ACA) - Answer - requires almost everyone to have health insurance that meets minimum standards, or pay a penalty
- Trump's tax reform bill eliminates penalty as of January 1st, 2019
State/Federal Health Insurance Exchanges/Marketplaces - Answer - Essential Health Benefits
- rate variation limits: states have developed a number of ways to regulate the characteristics that insurers use to vary premiums charged to different individuals and businesses in the marketplace.
- essential health benefits: ambulatory patient services, emergency services, hospital
ACA Financing - Answer - Medicare provider reimbursement: value-based purchasing method of payment (holds health care providers accountable for both the cost and quality of care they provide. It attempts to reduce inappropriate care and to identify and reward the best-performing providers).
- Medicare advantage payments: HMO, PPO
-Medicare Part A: covers inpatient care in a hospital, skilled nursing facility care, inpatient care in a skilled nursing facility-not custodial or long-term care, hospice care and home health care
- Medicare premiums: standardize premium amounts
- Medicare employer subsidy: allows employers and unions to continue helping their Medicare-eligible retirees get more generous drug coverage
- DSH payments: United States government provides funding to treat indigent patients through the Disproportionate Share Hospital programs.
Medicaid prescription drugs : all states currently provide coverage for all categorically eligible individuals as well as for most of other enrollees from outpatient prescription drugs as part of their Medicaid state programs
Income tax code provisions: The ACA subsidized the purchase of insurance by offering a tax credit to individuals and small employers for buying insurance, as well as placed taxes on individuals who have inadequate coverage and on employers not offering adequate coverage. An excise tax on high-cost health plans was imposed by the ACA to
raise revenue for insurance expansion and reduce health care costs. To generate added revenue for reform, the ACA levied excise taxes on the revenues of health insurers, pharmaceutical companies, and manufacturers of medical devices; increased taxes paid by high-income families; and increased limits on the income tax deduction for medical expenses.
- Health industry fees: intended to help pay for the implementation of the Affordable Care Act
- Health insu
ACA funding - Answer for:
- public health
- workforce
- prevention
- quality
National Federation of Independent Business v. Sebelius - Answer - individual mandate: sustained as a valid exercise of Congress's taxing power
- required Medicaid expansion: not a valid exercise of Congress's spending power as it would coerce states either to accept the expansion or face the possibility of losing all pre-existing Medicaid funding.
LETTING "OBAMACARE" FAIL - EXECUTIVE DECISIONS and JUDICIAL INTERVENTIONS - Answer - First Executive Order of Trump Presidency
- changes in open enrollment
Taxes to mandate penalty
Not financing subsidies of the plans
To include work requirements for Medicaid expansion
Reducing the protection of essential benefits
ACA- future -Solution - 2019 Elections "hot topic "Medicare for all"
