HMGT 3310 Chapter 5, HMGT 3310 Chapter 6, Quiz 3: Chapter 5 & 6, HMGT 3310 Final, Healthcare Regulations, Healthcare Regulations 2, HMGT 3310 Quiz 3 and 4

Which agency of the federal government has over site of non-bottled drinking water

Environmental Protection Agency (EPA)

Which agency of the federal government has oversite of non-bottled drinking water?

Environmental Protection Agency (EPA)

1996 Food Quality Protection Act

Established single standard for pesticides Uses "a reasonable certainty of no harm" policy Includes special protection for children

1938 Wheeler-Lea Act

Federal Trade Commission (FTC) charged with overseeing advertising of all FDA regulated products other than prescription drugs.

1905 - 1906: Pure Food and Drug Act and Meat Inspection Act

In 1904, The Jungle, an expose of the meat industry was released and in respite this act was passed. First time their was a regulation on food.

Public Health vs. Individual Liberty

Individual liberty is specific and in response to tragedy. What can they do? Does the gov. have a right to hold you? Problem with quarantine because of the constitution.

What are the three phases of FDA Drug Review for human testing?

Phase I: Small group w/ health volunteers phase II: Small group w/ targeted health condition phase III: large subject test of both healthy and those affected by condition, in clinical practice settings

________ is the most effective means of improving overall health of the populace.

Population Health

Advisory Committee

Review the new drug application and make recommendations. They can ask for more testing or change things.

The FDA __________.

is responsible for determining if a food or drug is safe and effective enough to be sold to the public. *Influence over >25% of the National Economy.

1962: Major Overhaul

move form safety to efficiency- mandated PTO filing

Epidemiology

Tracking national disease outbreaks. Attempting to cut off disease before an epidemic occurs.

Medicine Equity and Drug Safety Act

(Bill Clinton) wanted to allow the importing ,of foreign medication by pharmacists and whole sales to decrease costs however, FDA worried about the safety and regulations. Act died because of unrest and failure of the FDA to complete requirements for the act to pass.

2003 Medicare Prescription Drug Improvement and Modernization Act

(George W. Bush, Medicare Part D) This act made things super expensive b/c old people need really expensive drugs. Pharmaceutical companies lobbied that medicare can not negotiate prices because the Federal government will be restricting prices and competition.

What are the three phases of FDA Drug Review for human testing? PHASE 3:

- drug given to large group with target condition as they would in real clinical practice - testing in this phase can take several years - only 1/4 of drugs that entered the original process pass this phase

What are the three phases of FDA Drug Review for human testing? PHASE 2:

- small sample of subjects that suffer from target condition - adverse effects are monitored, if drug shows clinical benefit then optimum dosage range is refined - 1/3 of candidate drugs survive the end of this phase

What are the three phases of FDA Drug Review for human testing? PHASE 1:

- tests for safety in a small group of healthy volunteers -investigators determine whether larger trials are safe, establish safe dosage range, and detect toxicities - 1/3 of all drugs are abandoned at the end of this phase

The Social Determinants of Health

-neighborhood and built environment -health and health care -social and community context -education -economic stability *if one is broken it is all broken*

Core of cost of drugs is the ___________.

10 year testing process.

First vaccination was in ______ and was the _______ vaccine.

1796 ; small pox

What year was the Federation of State Medical Boards formed for the coordination of state licensing standards between states?

1912

FDA Regulatory Scope:

1970: Environmental Protection Agency - pesticides 1971: Added Radiologic exposure responsibility to FDA 1972: from NIH, all vaccine, blood products and other biologic oversight 1973: Sent oversight of toys and other consumer products to the CPSC 1976: Medical Device Amendments (now includes your Fitbit)

1848: Import Drugs Act

1st statute about drugs. Tried to ensure that drugs were safe. Did not address the states just a federal import law.

How many phases of drug review?

3

The National Science Foundation (circle all that apply): a. Promotes the use of computers in research and education b. Provides expertise in privacy of healthcare information c. Promotes basic research and education d. has a larger budget than the NIH

A and C

Population Health

Accountability to improve the health of a population. Not based on location but focused on a specific group of people.

340 B drug pricing program

Allows certain hospitals and organizations that see the poor to get discounts/free drugs/funding for these patients who can not pay for them. Issues because private hospitals also wanted some of this funding.

The Food drug and cosmetic act of 1938: a. was passed in response to a cosmetic public scandal b. required testing on only animal subjects before FDA approval c. required procedures to review the safety of new drugs before they came to market d. all of the above

C

Community Health

Communities (town/city) health of community can be determined in different ways. Often social determinants of health in relation to geography.

The Health Resources and Services Administration (HRSA) a. Has providing health care resources for medically underserved populations as its overall objective b. administers maternal and child health programs c. contains the HIV/Aids Bureau d. All of the above

D

The Orphan Drug Act: a. offers financial incentives to manufactures to develop drugs to create orphan drugs b. Defines orphan drugs as those that affect 200K people or fewer with a particular ailment c. extends patient exclusivity by 7 years for orphan drugs d. all of the above

D

The environmental protection agency: a. Regulates pesticides b. develops data on global warming c. plans for bioterrorism d. all of the above

D

Hatch-Waxman Act of 1984

Encouraged the creation of both generic and new medications by streamlining the process for generic drug approval and by extending patent licenses. 20 year patents.

National Institutes of Occupational Safety and Health (HIOSH)

Does research for the CDC

T or F: Hospitals are tax-exempt because providing healthcare is a public good and is considered an in inherent charitable purpose as defined by IRS non-profit regulations.

FALSE

T or F: The NIH houses 12 centers, institutes, and offices with various focuses on public health improvement and prevention.

FALSE

1953: Factory Inspection Amendment

FDA inspection reports to manufacturers

True of False (circle the correct answer): The NIH houses 12 centers, institutes and offices with various focuses on public health improvement and prevention.

False, 27 centers

1930: FDA Formation

Food and Drug Administration. Passed during the depression to help people and the economy.

The following are fraud and abuse safe harbors under the federal code of regulations passed in 1991:

Group purchasing of hospital supplies Investment Interests Office Space Rental Professional services of a physician as an independent contractor

ABC

HRSA administers the following programs (circle all that apply): a. Ryan White b. United Network for Organ Sharing c. The National Practitioner Databank d. The Veterans Administration

SAMHSA (Substance Abuse and Mental Health Services Administration)

Has receireved less attention and funding until recently- increased focus and funding as a result of shootings. Much more organized then MHMR.

Kafauver-Harris Amendment of 1962

Investigational Drugs-Adverse reaction must be reported to the FDA (Caused by Thalidomide drug for morning sickness that caused flipper arms deformity in babies)

Phase III

Large numbers of patients, a mixture of healthy and target group. In clinical practice setting, can take several years. Will introduce a placebo. Only 25% get through.

1954 Miller Pesticide Amendment

Limits on raw foods

Ryan White

Little boy who later died of AIDS following a blood transfusion. Helped educate the American public on AIDS and is to this day the largest founder for HIV/AIDS.

World War I: Venereal Disease and Sex ED

Men brought disease from Europe, commonly Venereal Disease so Sex ED became a thing to teach the causes and how to avoid.

The Health Care Quality Improvement Act of 1986) created what critical mechanism for monitoring and reporting of physician discipline?

NPDB (National Practitioner Database)

The NIH is made up of the following institutes

National Institute on Alcohol Abuse and Alcoholism National Institute of Child Health and Human Development

After Phase 1, 2, and 3, what must an applicant file with the FDA to get the drug approved for the market?

New Drug Application (NDA)

After Phase I, II and III, what must an applicant file with the FDA to get the drug approved for market?

New Drug Application (NDA)

Generics Post H-W Act

No phase I or II for generics; Increased generics market share x3. 18% to 44% in 12 years. This has increased the cost of drugs.

The DEA over sees ________.

Non-FDA Narcotics

Which of the federal government oversees the safety of worker's health while in the workplace?

OSHA

Which agency of the federal government oversees the safety of worker's health while in the workplace?

Occupational Safety and Health Administration (OSHA)

Public Health Services is made up of?

Office of Surgeon General, 2 bureaus for state support & medical services, Indian Health Services, and HRSA for workforce.

Generics

Once a patent for a brand drug expires (after 20 years), other manufacturers may copy the drug and release it under its pharmaceutical or "generic" name.

The States ___________.

Oversee prescribing behaviors and alcohol sales.

Before Drug review

PTO filling (Patent trademark). evaluation of safety and efficacy- confirm Investigational New Drug exemption requested by the FDA. Promise to follow rules and submit how study will go . Before human testing is animal testing

The legislative branch of government:

Passes statutes

The National Science Foundation:

Promotes the use of computers in research and education Promotes basic research and education

What is the Ryan White program and when was it established?

Provides HIV/AIDS services for low-income patients Established in 1990

The Health Resources and Services Administration (HRSA):

Provides health care resources for medically under served populations as its objective Administers maternal and child health programs Contains the HIV/AIDS Bureau

1983 Orphan Drug Act

Provides incentives to promote research, approval, and marketing of drugs needed for the treatment of rare diseases (<200,000 patients) . Allowed an add. 7 years of patenting, tax credits, and grants.

Environmental Protection Agency (EPA)

Public protection against exposure to environmental toxins (clean air, clean water, and natural environment protection acts). A few state funds but mostly Federal money.

Bureau of Alcohol, Tobacco, Firearms and Explosives

Regulate alchohol, tabacco, firearms and explosives

The Environmental Protection Agency (EPA):

Regulates pesticides Develops data on global warming Plans for bioterrorism

1914: Harrison Narcotics Tax Act

Required prescriptions for narcotics. A direct result of cocaine use.

Biggest jump in life expectancy is was when __________ was introduced.

Sanitation

Two infectious diseases that are hospital acquired.

Sepsis and Clostridum difficile (Cdiff)

USDA and FDA

Share responsibility for testing of domestic and imported agricultural products with pesticides

Phase I

Small group of health volunteers. This phase is to do a safety check off the drug. 33% do not pass.

Phase II

Small number of diseased patients. Assesses efficacy, dosing and adverse effects. 33% do not pass on.

Chronic disease became a 60's focus w/

Smoking/lung cancer; 1st time feds announced causation of disease (surgeon general)

Statistical Lives vs. Individual lives

Statistics is difficult to track. Preventative treatment vs. reactive care. Other countries are saving money on individual care by investing on statistical lives. In the US high lean towards Individual then statistical.

Medicare Part A covers hospital expenses for every US citizen over the age of 65, those who are total disabled, and individuals who require kidney dialysis for end-stage renal disease. True or False

TRUE

T or F: The Belmont Report promotes ethical guidelines for research subjects and is in part the basis for the federal government's regulation of human research.

TRUE

T or F: The Stark Law has a non-monetary exception in which hospitals can privide up to $416 in non-monetary benefits in 2019 to any physician with whom it has a financial relationship.

TRUE

T or F: The US spends less than 10% of overall health care spending on public health related services/programs.

TRUE

T or F: The federal government in April 2019 broke up a billion dollar nationwide Medicare scam involving kickbacks for certain medical devices.

TRUE

The "Oregon Experiment" began rationing care to Medicaid patients based on a cost to benefit ration in the 1990's True False

TRUE

The Americans with Disability Acts prohibits discrimination based on disability absent a compelling justification and requires public accommodations be made accessible to those with disabilities of any sort absent an unreasonable burden. True or False

TRUE

The Hill-Burton was significant as the first national healthcare financing initiative focusing on private providers. True False

TRUE

The National Committee for Quality Assurance was created as a private accrediting organization to supervise quality in managed care. True or False

TRUE

The VA, DOD and IHS are federal agencies that provide hospital and other healthcare services to more than 20 million Americans. True or False

TRUE

True or false Private citizens can proceed against a provider in a violation of fraud and abuse law through a "qui tam" action

TRUE

True or false The office of Civil Rights has enforcement authority for violations of the HIPAA privacy laws

TRUE

True or false: The CDC houses 12 centers, institutes, and offices with various focuses on public health improvement and prevention

TRUE

The Social Determinants of Health include:

The Built Environment Healthcare Economic Stability

D

The Environmental Protection Agency (EPA): a. Regulates pesticides. b. Develops data on global warming. c. Plans for bioterrorism. d. All of the above.

C

The Food, Drug, and Cosmetic Act of 1938: a. Was passed in response to a cosmetic public scandal. b. Required testing on only animal subjects before FDA approval. c. Required procedures to review the safety of new drugs before they came to market. d. All of the above.

HIPAA stands for:

The Health Insurance Portability and Accountability Act

D

The Health Resources and Services Administration (HRSA): a. Has providing health care resources for medically undeserved populations as its overall objective. b. Administers maternal and child health programs. c. Contains the HIV/AIDS Bureau. d. All of the above.

AD

The NIH is made up of the following institutes (circle all that apply): a. National Institute on Alcohol Abuse and Alcoholism b. National Institute of Cancer Care c. National Institute of Healthcare Administrative Practices d. National Institute of Child Health and Human Development

Access to Clinical Trials

The National Institute of Health makes a public registry of trials so that the public can see trials, locations, and even sign up.

AC

The National Science Foundation (circle all that apply): a. Promotes the use of computers in research and education. b. Provides expertise in privacy of healthcare information. c. Promotes basic research and education. d. Has a larger budget than the NIH.

Explain what the Orphan Drug Act is and why it was passed a law and regulated:

The Orphan Drug Act incentives manufacturers to make medication to treat rate conditions. Authorized grants, tax credits, and add. seven years of patent. It is regulated by the FDA. It was passed because there was no facilitation of drugs for rare diseases that affect small numbers of individuals.

D

The Orphan Drug Act: a. Offers financial incentives to manufacturers to develop drugs to create orphan drugs. b. Defines Orphan Drugs as those that affect 200,000 people or fewer with a particular ailment. c. Extends patent exclusivity by 7 years for orphan drugs. d. All of the above.

What is the Ryan White. program and when was it established?

The Ryan White program is the largest funder for HIV/AIDS is specifically for children began in 1980

Which of the following apply to social determinants of Health include: a) The Built Environment b) Healthcare c) Economic Stability d) Childhood immunization registries d) none of the above

The Social Determinants of Health: -Neighborhood & Built environment -Health and Healthcare -Social and community context -Education -Economic Stability a, b, c

U.S. spending on health care & public health.

The U.S. spends more on health, less on social but has worse results in terms of life expectancy.

Data Privacy laws and regulations are promulgated by:

The federal government State governments

ABCD

The following are fraud and abuse safe harbors under the federal code regulations passed in 1991 (circle all that apply): a. Group purchasing of hospital supplies. b. Investment interests. c. Office space rental. d. Professional services of a physician as an independent contractor.

Drug Testing in Children

There are consent issues with pediatric drugs. Issues in deciding what parents can and can not approve, in terms of research.

1951 Durham-Humphrey Amendment

This act distinguishes prescription from the over the counter drugs . This act requires companies to label prescription drugs "Caution:Federal law prohibits dispensing without a prescription", requires physician supervision for the purchase of prescription drugs. Also, over the counter drugs without medical supervision are required to have on the label: Product Name, Name and Address of manufacturer, Active ingredients, quantities of all other ingredients whether active or not

1938: Food, Drug, and Cosmetic Act

This act made the food and Drug Act more comprehensive to include cosmetics. The act also defines misbranding or adulteration of drugs to be illegal, This act requires drug companies to provide package inserts,requires that habit-forming drugs be labeled "may be habit forming" , requires that a new drug has to be proven safe under FDA guidelines before marketing

1912: Shirley Amendment

This act protects against false therapeutic claims; stopped people form selling things that could divert from actual medicine

True or False (circle the correct answer): The US spends less than 10% of overall health care spending on public health related services/programs.

True

True or False: The most significant aspect of pharmaceutical regulation that falls outside of the FDA's jurisdiction is the control narcotics which are regulated by the Drug Enforcement Administration

True

True

True or False: Private citizens can proceed against a provider in violation of fraud and abuse law through a "qui tam" action.

True

True or False: The CDC houses 12 centers, institutes, and offices with various focuses on public health improvement and prevention.

True

True or False: The Office of Civil Rights has enforcement authority for violations of the HIPAA privacy laws.

True

True or False: The most significant aspect of pharmaceutical regulation that falls outside of the FDA's jurisdiction is the control of narcotics, which are regulated by the Drug Enforcement Administration.

1862: Bureau of Chemistry in USDA

US Department of Agriculture, 1st agency to look at drugs. Focusing on how the drugs were made and what they were made of.

Acute vs. Chronic Disease

Used to be responsive to outbreaks and other; now we spend a lot of effort on preventing Chronic Disease (ex: lung disease)

1902: Biologics Control Act

Vaccine manufacture and distribution. A reaction of children dying.

HRSA adminstrators the following programs (circle all that apply): a. Ryan White b. United Network for Organ Sharing c. The National Practitioner Databank d. The Veterans Adminstration

a, b, c

The following are fraud and abuse safe harbors under the federal code regulations passed in 1991: (circle all that apply) a. group purchasing of hospital supplies b. investment interests c. office space rental d. professional services of a physician as an independent contractor

a, b, c, d

The NIH is made up of the following institutes (circle all that apply): a. National Institute on Alcohol abuse and Alcoholism b. Nation Institute of Cancer Care c. National Institute of Healthcare Adminstrative Practices d. National Institute of Child health and Human Development

a, d

Medicare covers the following: a. Part A: hospital care b. Part B: physician care c. Part C: long term nursing home care d. Part D: prescription reimbursement

a. Part A: hospital care b. Part B: physician care d. Part D: prescription reimbursement

Local vs. State vs. Federal

all have different regulations on public health. State = water; Local = food handler;

United States Environmental Protection Agency

an agency of the U.S. federal government which was created for the purpose of protecting human health and the environment by writing and enforcing regulations based on laws passed by Congress.

1958 Food Additives Amendment

approval of new food additives was required before they could be marketed, and the responsibility for proving their safety was placed on the manufacturer.

Which of the following apply to the Health Resources and Services Administration (HRSA): a) Provides health care resources for medically underserved populations as its overall objective b) Administers maternal and child health programs c) Contains the HIV/AIDS Bureau d) All the above

d) All the above

Which of the following apply to Environmental Protection Agency (EPA): a) Regulates pesticides b) develops data on global warming c) plans for bioterrorism d) all of the above

d) all of the above

Which agency(s) have been involved in federal participation tin the oversight of trauma care? a. CDC (Center for Disease Control) b. NHTSA (National Highway Traffic Safety Administration) c. HRSA (Health Resources and Services Administration) d. All of the above

d. All of the above

Which statements are true about CLIA (Clinical Laboratory Improvement Amendments) regulations? a. Implementation of CLIA standards is primarily a function of CMS b. CLIA applies to hospital labs and physician office labs c. Implementation is funded by user fees d. All of the above

d. All of the above

Which of the following organizations tests and initiatives are sponsored, cosponsored or owned by the Federation of State Medical Boards? a. Accreditation Council for Graduate Medical Education b. United States Medical Licensing Examination c. Educational Commission for Foreign Medical Graduates d. National Board of Medical Examiners

d. National Board of Medical Examiners

Which of the following are NOT agencies of the federal Department of Health and Human Services? (circle all that apply) a. Administration on Aging b. Agency for Healthcare Research and Quality c. Centers for Disease Control and Prevention d. The Office of Community Planning and Development e. Office of Healthy Homes and Lead Hazard Control

d. The Office of Community Planning and Development e. Office of Healthy Homes and Lead Hazard Control

1987 Prescription Drug Marketing Act

enacted labeling and marketing rules. Started increasing ad costs. Drugs are now being sold directly to the public.

What happens if all three stages of the drug review process are passed?

file new drug application.

Prescription Drug User Fee Act

new time limits and manufacturer payments

herbal supplements are _________ regulated.

not

1997 Food and Drug Administration Modernization Act

off-label uses of drugs are clarified. Using drugs for their not approved use is not illegal but FDA is not guaranteeing the drug will work but it is certifying it is safe. Just because using drugs for a different thing then what they were created for is not illegal does not mean their is no malpractice risks.

FTC (Federal Trade Commission)

prevents the unfair, false, or deceptive advertising of drugs and medical devices.

Occupational Safety and Health Administration (OSHA)

protects workers from toxic substances

1990 Medical Device Act

reporting requirements to FDA post market. Hospitals, nursing homes, and clinicians are required to report faulty devices. Faulty devices result in recalls.

Mental Health and Mental Retardation (MHMR)

services established in 1964, began with federal funding but has moved to state funding

Right to Try 2018

terminally ill patients can try experimental drugs if their is no other options for the patient.

Orange Book

the common name for the FDA's Approved Drug Products with Therapeutic Equivalence and prices.

If the new drug application has FDA approval

then it goes to market

Generics Pre H-W Act

treaded by FDA as a new drug for FDA approval process

1960 Color Additives Amendment

use of color additives is subject to FDA approval