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Health Care Regulation in AmericaComplexity, Confrontation, and Compromise$

Robert I. Field

Print publication date: 2006

Print ISBN-13: 9780195159684

Published to Oxford Scholarship Online: September 2009

DOI: 10.1093/acprof:oso/9780195159684.001.0001

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(p.251) Appendices

(p.251) Appendices

Source:
Health Care Regulation in America
Publisher:
Oxford University Press

Appendix A

Major Health Care Regulatory Agencies and Organizations

Level of Regulation

Agency

Primary Health Regulatory Function

Chapters in which Primary Functions are Discussed

Federal Agencies

Department of Health and Human Services (DHHS) (formerly Department of Health, Education and Welfare [DHEW])

Implements most of the federal health care regulatory infrastructure though component agencies

1

Components of DHHS

Agency for Healthcare Research and Quality (AHRQ)

Funds research on health services

8

Centers for Disease Control and Prevention (CDC)

Compiles and disseminates national health care data, investigates disease outbreaks, researches public health threats

6

Centers for Medicare & Medicaid Services (CMS) (formerly Health Care Finance Administration [HCFA])

Administers the Medicare program and the federal portion of the Medicaid program and State Children’s Health Insurance Program

4

Food and Drug Administration (FDA)

Oversees the safety of drugs, medical devices, biologic products, food, and cosmetics

5

Health Resources and Services Administration (HRSA)

Administers funding programs for health care training, the National Practitioner Data Bank for physician disciplinary actions, and coordinates the organ donation network (UNOS)

2, 8

Indian Health Service (IHS)

Operates hospitals and provides other health care services for Native Americans

3

National Institutes of Health (NIH)

Funds biomedical and related research at universities, institutes, and hospitals and conducts intramural research

8

Substance Abuse and Mental Health Services Administration (SAMHSA)

Funds community mental health services

6

Office for Civil Rights (DHHS)

Enforces privacy provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and civil rights protections

3,7

Office of Inspector General (DHHS)

Enforces prohibition against fraud in billing federal health care payment programs and against payments for referrals

7

Other Federal Agencies

Environmental Protection Agency (EPA)

Regulates the discharge of environmental pollutants

6

Occupational Safety and Health Administration (OSHA)

Regulates workplace safety and health

6

United States Department of Agriculture (USDA)

Regulates food safety, conducts research on food safety

6, 8

Department of Defense (DOD)

Operates hospitals and provides other health care services for active-duty military personnel, their dependents, and retirees

3

Department of Homeland Security (DHS)

Coordinates responses to natural disasters and bioterrorist attacks

6

Department of Justice (DOJ)

Enforces antitrust laws and prohibition on payments for referrals

7

Department of Labor (DOL)

Administers Employee Retirement Income Security Act of 1974, which applies to employee health benefits arrangements

4

Federal Trade Commission (FTC)

Enforces antitrust laws, regulates advertising of nonprescription drugs

5, 7

Internal Revenue Service (IRS)

Regulates the structure and activities of nonprofit hospitals and other health care institutions that are recognized as tax-exempt

7

National Science Foundation (NSF)

Funds basic science research

8

Patent and Trademark Office (PTO)

Grants patents for new inventions and discoveries, including drugs and devices

5

Veterans Administration (VA)

Operates hospitals and other health care services for veterans, conducts and funds research on health services

3, 8

State Agencies

Departments of health

Investigate public health threats, house licensure boards in some states, administer health planning and certificate-of-need programs in some states, regulate clinical operations of managed care organizations

2, 3, 6

Boards of medicine

License and discipline physicians

2

Boards (other health professions)

License and discipline allied health professionals

2

Departments of welfare

Administer Medicaid programs in many states

4

Departments of insurance

Regulate the sale and underwriting of private health insurance, including managed care arrangements, except when preempted by ERISA

4

Local Agencies

Departments of health

Investigate public health threats, inspect restaurants and other public facilities

6

Private Organizations

Accreditation Council on Graduate Medical Education

Accredits medical residency programs

2

American Board of Medical Specialties (ABMS)

Coordinates activities of medical specialty societies

2

Association of Schools of Allied Health Professions (ASAHP)

Coordinates the certification of training programs for allied health professionals

2

Educational Commission for Foreign Medical Graduates (ECFMG)

Certifies graduates of foreign medical schools to enter ACGME-accredited medical residencies and fellowships

2

Federation of State Medical Boards (FSMB)

Coordinates some activities of state physician licensure agencies, including maintenance of records of physicians who have been disciplined

2

Joint Commission on Accreditation of Healthcare Organizations (JCAHO)

Accredits hospitals and other kinds of health care facilities

3

Liaison Committee on Medical Education (LCME)

Accredits medical schools

2

Medical specialty societies

Certify physicians as qualified to practice in medical specialties

2

National Board of Medical Examiners (NBME)

Develops and administers the examination for medical licensure that is used by all states

2

National Committee on Quality Assurance (NCQA)

Accredits managed care plans and related organizations

4

United Network for Organ Sharing (UNOS)

Administers system for allocating organs for transplantation

3

(p.253) (p.254) (p.255) (p.256)

(p.257) Appendix B

Chronology of Major Developments in Public Health Regulation

State and Local Health Departments

1790–1820

Some eastern port cities developed municipal agencies to fight epidemics; New York City advisory board of health established

1820–1840

Only five city boards of health are in existence

1840–1860

Louisiana experiments with state board of health, and it fails

1860–1880

First permanent state board of health established in Massachusetts

1920–1940

By 1928, 208 county health departments in 17 states; Social Security Act provides grants for state and local health departments

Centers for Disease Control and Prevention (CDC)

1940–1960

Malaria Control in War Areas becomes CDC; helps to develop polio and influenza vaccinations; Epidemic Intelligence Service created (EIS)

1960–1980

Mortality and Morbidity Weekly Report published; smallpox eradicated; last case of polio in United States

1980–present

First case of AIDS identified; CDC responds to first bioterrorism attack

Environmental Protection Agency (EPA)

1920–1940

Soil Conservation Service founded; state fish and wildlife programs established; Oil Pollution Act passed

1940–1960

Clean Air Act passed; Clean Water Act passed

1960–1980

National Environmental Protection Act; EPA opens its doors

Occupational Safety and Health Administration (OSHA)

1960–1980

Occupational Safety and Health Act passed; OSHA created; first standards developed to protect Americans at work

Agency for Toxic Substance and Disease Registry (ATSDR)

1960–1980

Resource Conservation Recovery Act passed

1980–present

CERCLA (Superfund Act) passed; ATSDR created

Department of Agriculture (USDA)

1790–1820

New York State Board of Agriculture (first state board) created

1820–1840

First committees on agriculture in Congress

1860–1880

USDA set up with focus on the science of agriculture; a few states inspect dairy products

1880–1900

Meat Inspection Acts of 1890 and 1891 passed; USDA raised to cabinet level; first state agriculture department established in Georgia

1900–1920

Meat Inspection Act of 1906 passed; Insecticide Act passed

1940–1960

Poultry Products Inspection Act passed

Health Resources and Services Administration (HRSA)

1960–1980

HRSA created to hire National Health Service Corps personnel, manage community health centers, and administer national health care workforce management programs

Other Significant Developments

1790–1820

First dispensaries established to care for health of the poor

1860–1880

Quarantine Act of 1873 passed; National Board of Health created (and dismantled four years later)

1880–1900

Bacteria discovered; germ theory proposed; Act to Establish a Hospital Corps passed

1900–1920

Development of epidemiology and biostatistics as scientific disciplines; first Food and Drug Act passed

1920–1940

Social Security Act passed; Food, Drug and Cosmetic Act passed; Nurse Training Act passed

1940–1960

Hill-Burton Act passed to promote hospital construction; Mental Health Act passed

1960–1980

Medicare and Medicaid enacted; Civil Rights Act passed; Health Professions Education Assistance Act passed; Lead Based Paint Poisoning Prevention Act passed

1980–present

Managed care begins to proliferate; Americans with Disabilities Act passed; Health Insurance Portability and Accountability Act passed

(p.258)

(p.259) Appendix C

List of Acronyms

AACOM

American Association of Colleges of Osteopathic Medicine

AAMC

Association of American Medical Colleges

ABMS

American Board of Medical Specialties

ACGME

Accreditation Council for Graduate Medical Education

ACS

American College of Surgery

AHRQ

Agency for Healthcare Research and Quality (in DHHS)

AIDS

acquired immune deficiency syndrome

ALF

assisted living facility

ALJ

administrative law judge

AMA

American Medical Association

ANA

American Nurses Association

AOA

American Osteopathic Association

AOTA

American Occupational Therapy Association

APC

ambulatory payment classification group

APhA

American Pharmacists Association

APTA

American Physical Therapy Association

APA

American Psychological Association

ASAHP

Association of Schools of Allied Health Professions

ATSDR

Agency for Toxic Substances and Disease Registry (in EPA)

BBA

Balanced Budget Act of 1997

BPHC

Bureau of Primary Health Care (in HRSA)

BHPr

Bureau of Health Professions (in HRSA)

CARF

Commission on Accreditation of Rehabilitation Facilities

CDC

Centers for Disease Control and Prevention (in DHHS)

CERCLA

Comprehensive Environmental Response, Compensation and Liability Act of 1980

CMHS

Center for Mental Health Services (in SAMHSA)

CDER

Center for Drug Evaluation and Research (in FDA)

CLIA

Clinical Laboratory Improvement Amendments

CMS

Centers for Medicare & Medicaid Services (in DHHS) (formerly HCFA)

CNPP

Center for Nutrition Policy and Promotion (in USDA)

COBRA

Comprehensive Omnibus Budget Reconciliation Act of 1986

COGME

Council on Graduate Medical Education

CON

certificate-of-need

CPSC

Consumer Product Safety Commission (United States)

CSAP

Center for Substance Abuse Prevention (in SAMHSA)

CSAT

Center for Substance Abuse Treatment (in SAMHSA)

DESI

drug efficacy study implementation

DOJ

Department of Justice (United States)

DHS

Department of Homeland Security (United States)

DHS

Department of Health Services (California)

DHEW

Department of Health, Education, and Welfare (United States) (now DHHS)

DHHS

Department of Health and Human Services (United States) (formerly DHEW)

DOD

Department of Defense (United States)

DOE

Department of Energy (United States)

DOL

Department of Labor (United States)

DRG

diagnosis-related group

DSHEA

Dietary Supplement Health and Education Act of 1994

DTC

direct-to-consumer advertising

EBSA

Employee Benefits Security Administration (in DOL) (formerly PWBA)

ECFMG

Educational Commission for Foreign Medical Graduates

EEOC

Equal Employment Opportunity Commission (United States)

ELSI

Ethical, Legal, and Social Issues research program (in HGP)

EMCRO

experimental medical care review organization (in HCFA)

EMS

emergency medical services

EMTALA

Emergency Medical Treatment and Active Labor Act of 1986

EPA

Environmental Protection Agency (United States)

EPSDT

Early Periodic Screening, Diagnosis, and Treatment (in Medicaid)

ERISA

Employee Retirement Income Security Act of 1974

ERS

Economic Research Service (in USDA)

ESRD

end-stage renal disease

FDA

Food and Drug Administration (in DHHS)

FDAMA

Food and Drug Administration Modernization Act of 1997

FEHBP

Federal Employee Health Benefit Plan

FEMA

Federal Emergency Management Agency (in DHS)

FNS

Food and Nutrition Service (in USDA)

FSIS

Food Safety and Inspection Service (in USDA)

FSMB

Federation of State Medical Boards

FTC

Federal Trade Commission (United States)

GAO

Government Accountability Office (formerly General Accounting Office)

HCFA

Health Care Finance Administration (in DHHS) (now CMS)

HCQIA

Health Care Quality Improvement Act of 1986

HEDIS

health plan employer data and information set

HGP

Human Genome Project (in NIH)

HIBAC

Health Insurance Benefits Advisory Council (in SSA)

HIP

Health Insurance Plan of New York

HIPAA

Health Insurance Portability and Accountability Act of 1996

HMO

health maintenance organization

HRSA

Health Resources and Services Administration (in DHHS)

HSA

health systems agency

HSCRC

Health Services Cost Review Commission (Maryland)

ICF

intermediate care facility

IDS

integrated delivery system

IHS

Indian Health Service (in DHHS)

IND

investigational new drug exemption

IOM

Institute of Medicine (in the National Academy of Sciences)

IRB

institutional review board

IRC

Internal Revenue Code of 1986

IRS

Internal Revenue Service (United States)

JCAHO

Joint Commission on Accreditation of Healthcare Organizations

LCME

Liaison Committee on Medical Education

MCAC

Medicare Coverage Advisory Commission (in DHHS)

MCE

medical care evaluation study

MedPAC

Medicare Payment Advisory Commission (in DHHS)

MMA

Medicare Prescription Drug, Improvement, and Modernization Act of 2003

NAIC

National Association of Insurance Commissioners

NAPH

National Association of Public Hospitals

NBME

National Board of Medical Examiners

NCD

national coverage determination

NCHGR

National Center for Human Genome Research (in NIH)

NCI

National Cancer Institute (in NIH)

NCVHS

National Committee on Vital Health Statistics (in DHHS)

NEPA

National Environmental Policy Act

NCHS

National Center for Health Statistics (in CDC)

NCQA

National Committee on Quality Assurance

NDA

new drug application

NHTSA

National Highway Traffic Safety Administration (in the Department of transportation)

NIH

National Institutes of Health (in DHHS)

NIOSH

National Institute of Occupational Safety and Health (in CDC)

NPDB

National Practitioner Data Bank (in HRSA)

NSF

National Science Foundation (United States)

OAS

Office of Applied Studies (in SAMHSA)

OCR

Office for Civil Rights (in DHHS)

OIG

Office of Inspector General (in DHHS)

OPM

Office of Personnel Management

OPTN

Organ Procurement and Transplantation Network

OSCAR

On-Line Survey, Certification, and Reporting System

OSHA

Occupational Safety and Health Administration (in DOL)

OTC

over-the-counter drug

PBGC

Provider Reimbursement Review Board (in CMS)

PBGC

Pension Benefit Guarantee Corporation

PBM

pharmacy benefit manager

PDP

prescription drug plan

PDUFA

Prescription Drug User Fee Act of 1992

PHC4

Pennsylvania Health Care Cost Containment Council (Pennsylvania)

PHS

Public Health Service (in DHHS)

POS

point-of-service plan

PPO

preferred provider organization

PPRC

Physician Payment Review Commission (in HCFA)

PRO

professional review organization (in HCFA)

ProPAC

Prospective Payment Assessment Commission (in HCFA)

PRRB

Provider Reimbursement Review Board (in CMS)

PSO

patient safety organization

PSRO

professional standards review organization (in HCFA)

PTO

Patent and Trademark Office (United States)

PWBA

Pension and Welfare Benefits Administration (in DOL) (now EBSA)

QAPI

quality assessment and performance improvement

QIO

quality improvement organization (in CMS)

RBRVS

resource-based relative value scale

RUG

resource utilization group

SAMHSA

Substance Abuse and Mental Health Services Administration (in DHHS)

SCHIP

State Children’s Health Insurance Program

SEC

Securities and Exchange Commission (United States)

SEOPF

Southeast Organ Procurement Foundation

SRG

Scientific Research Group (in NIH)

SNF

skilled nursing facility

SRS

Social and Rehabilitative Service Administration (in DHHS)

SSA

Social Security Administration (in DHHS)

SSI

Supplemental Security Income

TEFRA

Tax Equity and Fiscal Responsibility Act of 1982

UBIT

unrelated business income tax

UNOS

United Network for Organ Sharing

USDA

United States Department of Agriculture (United States)

VA

Veterans Administration (United States)

(p.260) (p.261) (p.262)