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86 Cards in this Set
- Front
- Back
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Hospital Rate Regulation
-What is the original impetus for state-based hospitals for and when? |
Legislation passed by Congress in 1972 and 1983 encouraging states to develop and implement health care cost containment measures.
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Hospital Rate Regulation
-What did states employ? |
Some states "per diem" rate controls on amount charged for each day of impatient stay; others "per case" rates based on amount charge for treatment
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Hospital Rate Regulation
Which states implemented most aggressive programs? What made them aggressive? |
MA, NJ, NY, MD - representative of "all-payer" mandatory rate setting systems. To develop programs applied across all sources or reimbursement, waivers of fed rules under Medicare/aid were required. All states but MD abandoned programs.
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Hospital Rate Regulation
MD program HSCRC |
Overseen by Health Services Cost Review Commission - sets identical rates for care for all payers (ins companies, govt, individuals). State hospital costs lower than national average, hospitals provide lots of uncompensated care.
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Additional Regulation of Hospital Access
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Medicare prospective payment, rate regulation, CON-cost control. No universal right to non emergency care in America, patients are protected form some abuse.
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Additional Regulation of Hospital Access - What are hospitals rights and can they discriminate?
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Hospitals may decline non ER care if patient can't pay. Hospitals cant pick patients based on disability, race, color, national origin (Americans with Disabilities Act 1991 and Civil Rights Act 1964
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Access to Care for Those Who Face Physical Barriers: Americans with Disabilities Act 1991 - Impairments that limit access?
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Wheelchair, visual and hearing impairments, AIDS. Discrimination based on perception that they can't function normally. (Employment, services, healthcare)
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Americans with Disabilities Act - What does it do?
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Act prohibits discrimination based on disability without justification. "Public accommodations" and requires access to those with disabilities.
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Americans with Disabilities Act - Exceptions?
Federal Rehabilitation Act |
If creating access would present "unreasonable burden" (high cost).
Rehab Act - 1973 - Section 504 - prohibits discrimination based on disability to programs receiving federal funding. |
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Access to Care for Those Who Face Physical Barriers:
ADA |
ADA regulates - must maintain facilities with access to people with disabilities in hospital and may not refuse services or employment.
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Access to Care for Those Who Face Physical Barriers:
OCR, EEOC |
Office or Civil Rights - handles complaints and initiates investigations. Equal Opportunity Commission appointed by President, enforces non discrimination statutes investigating complaints and initiating lawsuits when violate. Guide compliance with antidiscrimatory laws
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Enforcing Nondiscrimination Protections: The Civil Rights Act
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1964 -Enforced by OCR and EEOC- Title VI applies to discrimination based on race, color, or national origin by program receiving Fed Assistance. Title VII discrimination in employment
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Enforcing Nondiscrimination Protections: The Civil Rights Act
IRS |
IRS- "charitable mission" - healthcare services in non discriminatory manner because of tax exempt status.
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Government-Run Hospitals
Federal Hospital Care VA |
Department of Veterans Affairs 1930- facilities provide care to more than 5 million patients/year. Major site for medical training. More than half physicians received some training in VA health system. Achieved cabinet level status 1989
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Government-Run Hospitals
Federal Hospital Care DOD |
Department of Defense covers 9 million active duty militants, dependents, and retirees. 60% military care in DOD facilities. "TRICARE" managed care plan.
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Government-Run Hospitals
Federal Hospital Care IHS |
Indian Health Services for Native Americans includes 1.6 million people. Fed funds in 1921. IHS created in 1955. Indian Self Determination and Education Assistance Act 1975 - tribes can operate services themselves or IHS system.
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State and Local Public Hospitals
# Hospitals Large Cities |
More than 1,300 hospitals in US. Larger cities, NY, LA, Chicago operate major institutions train med students, residents, and conduct research.
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State and Local Public Hospitals
What is offered in large cities and where money comes from? |
Many offer advanced high technology services (trauma and burn treatment). Much care in uncompensated and budgets supplemented by tax revenues.
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State and Local Public Hospitals
NAPH |
National Association of Public Hospitals represents interest of public hospitals and health systems. Promotes concerns before congress and state legislatures, conducts research on issues of management.
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Long Term Care Oversight and the Federal-State Approach to Regulating Nursing Homes - Who and How long?
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Acute care hospitals provide treatments with time limited course. People who aren't able to function independently transfer to long-term care facility
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Chapter 2 - Regulation of physician education, licensure, discipline, specialty certification, credentialing
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AMA founded to strengthen requirements for physician education. Carnegie - Flexner Report - raised standards of med schools.
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Chapter 2 - Professional self regulation
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State licensure is form of self-regulation, interest may be in reputation of profession.
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Chapter 2 - State vs. federal vs. private
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Mostly regulated by state and private. Congress added several layers of federal oversight to address regulatory gaps.
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Chapter 2 - Other professions (Allied Health)
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Nursing, dentistry, pharmacy, pt, ot, psychology. Standardize education through private organizations with state board verifying training and licensing.
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Chapter 3 - Beginnings of hospitals as institutions
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Began as wards for sick, religious, served poor, almshouses. Penn hospital first. Nightingale - started nursing as profession because of war in turkey.
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Chapter 3 - JCAHO - overview of their involvement
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Joint Commission on Accreditation of Healthcare Organizations - sends auditors to survey facilities for compliance with quality standards and accredits if pass. Needed for reimbursement of Medicare/Aid
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Chapter 3 - JCAHO - purpose, cycle period,
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To place outside party in position to enforce standards that protect public welfare. 3 year audit cycle.
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Chapter 1 - What is regulation?
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Process of making things regular, standardized, predictable, consistent, measurable, normal, common, not automatic, not predetermined
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Chapter 3 - Emergency services - National Highway Safety Act
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1966 - death/auto accidents, statewide EMS - Allocated funding to states to improve ambulance services and overall trauma care (FL, IL, MD)
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Chapter 3 - Emergency services - JCAHO - What they look for?
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Completeness of medical charts, structure medical staff bylaw, implementation of OR procedures, minutes, of medical staff committee, process of quality assurance.
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EMTALA - Regulation of Access to ER
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Emergency Medical Treatment and Active Labor Act – 1986 – part of COBRA – hospitals that participate in Medicare must provide appropriate medical screening to all patients in Emergency room regardless of pay. Must also stabilize patients before transfer or discharge. Women in labor must receive OB care. Penalties include fines and exclusion from Medicare or lawsuits.
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Regulation of Access to ER
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Congress passed EMTALA because of common transfer of patients before they were medically stable. Hospital operations regulated at state level. EMTALA does not require hospitals to maintain service, only open to all regardless of pay if they do have service
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Regulation of Clinical Labs, CLIA, HCFA
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Clinical Laboratory Improvement Amendments – 1988 – create quality standards for labs and gave responsibility for implimentation to Health Care Finance Admin. Law applies to labs in hospitals, physicians offices, and private labs.
Combo of costs and user fees have driven smaller labs out of business. |
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Regulation of clinical labs - classification of lab tests - Categories
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Lowest level – “waived tests” – lab must enroll in CLIA and pay fee but only need to follow manufacture’s instructions.High complexity tests – compliance with strict quality rules.
Half of states impose own licensure requirements |
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Economic Regulation of Hospital Supply and Rates
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Regulating safety of hospitals to protect public against deficient care and to enhance and maintain quality of care. Regulate through economic oversight
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Chapter 3 - Hill Burton Act
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Budgets of NIH grew new type of health insurance began to spread.
Geography created barrier people who lived inner city and ones who lived to far away. Hospital Survey and Construction Act- 1946 – approved new spending to create and expand hospitals. Reached $3.7 billion |
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Chapter 3 - Hill Burton Act
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Hospitals required to provide min amounts of care to operate ERs and not discriminate by race. Where funds used. Creation of local planning boards in each state to recommend spending priorities. Boards laid groundwork for comprehensive health planning system that was implemented in 1960s.
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Chapter 3 - Health Planning and CON, HSA
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Comprehensive Health Planning and Services Act. Funded state public health services and encouraged states to use health planning to achieve geographic coverage. HSA – Health Systems Agencies -conduct planning at local level. Make grants for needed resources, approve fed funding, evaluate need for new facilities, 5 year evaluations of facility reqs. Before any new facility is made or changed, have to make case and get CON.
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Chapter 3 - Health Planning and CON
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States required to implement. Certificate of Need – hospitals permitted to spend funds for new health care services, facilities, and equipment only if need was identified in region. Also to reduce hospital costs. Milton Roemer – when 3rd party pays bills, hospital beds will be filled as long as available. Congress hoped CON reduce demand and lower spending
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Chapter 3 - Health Planning and CON
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CON programs may reduce unnecessary use of health care services but make more difficult to obtain by limiting locations. Hospital only programs may give advantage to other facilities adding services or expand w/out state approval. Programs that regulate all facilities may become too expensive for smaller facilities like physician offices.
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Indirect Cost control through Medicare Reimbursement, DRGs
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System of reimbursement for acute care hospital services based on “diagnosis-related groups. ”Developed to govern medicare/aid payment but prompted private insurance plans to adopt DRG-based reimbursement
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DRG Approach
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Diagnosis-related groups – 1980 – started NJ Medicaid program - developed to replace cost base reimbursement where hospitals were paid for actual service – hospitals had no incentive to control costs. Designed to pay set amount per patient based on medical need; rewards efficiency and penalizes waste. Adopted by Fed Govt for Medicare 1983 and later by states for Medicaid
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DRG - Categories? Regulated by? Administered payments?
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Grouped into 540 categories – each has payment assigned based on typical cost. Few exceptions, payment uniform for patients. Regulated by CMS and payments subject to adjustment over time. CMS also administers payments to teaching hospitals to cover training costs and inner city and rural hospitals that treat “disproportionate share”
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DRG - Taught Hospitals 3 things? RUGS? APCs?
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Importance of financial efficiency, technique to game system by switching from inpatient to outpatient, and focus on providing services DRG pays most for. RUGs – resource utilization groups – for long term care. APCs – Ambulatory payment classification – for outpatient hospital services
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Chapter 3 - Organ Donation/Transplant
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Can give to to full life. Replacement must come from donor whose tissues match according to biological markers. Must be quick. UNOS - United Network of Organ Sharing - functions under govt supervision.
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Chapter 3 - Organ Donation/Transplant - SEOPF
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Southeast Organ Procurement Foundation - First coordinating organization for organ donations. Implemented first computer based matching system in 1977.
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Chapter 3 - Organ Donation/Transplant National Organ Transplant Act- HRSA
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National Organ Transplant Act - created Organ Procurement and Transplantation Network. HRSA oversees National Marrow Donor Program - standardized waiting list. Ethical/moral personal behavior choices.
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Chapter 4 - Healthcare financing
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Federal share 50/60 (50% of people and 60% of costs); components.
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Chapter 4 - Healthcare financing - Insurance - Beginnings
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Fee for service in beginning. BC - school teachers at Baylor University Hospital after Depression. Designed not for profit originally. BS - Physician services.
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Chapter 4 - Healthcare financing - Insurance - NAIC
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National Association of Insurance Commissioners - Develops uniform laws recommended for states. Permits state regulators to address areas of common concern - regulatory policy toward managed care. Has no authority but gives weight to legislators.
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Chapter 4 - Healthcare financing - Insurance - Managed Care - Types?
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Outgrowth of direct service plans developed during 1940s. Original form-HMO (health management)-uses several tools to manage health care control costs mostly in physician reimbursement (monthly fee "capitation"). Also PPOs (preferred provider org) and POS (point of service)
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Chapter 4 - Healthcare financing - Insurance - Federal State Balance - Step 1 - McCarran Ferguson Act
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Congress assigned regulatory authority over insurance over to states. Premium rates, policy language, financial reserves, accounting practices, marketing activities, unfair claims practices. Differ by state.
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Chapter 4 - Healthcare financing - Insurance - Step 3 - ERISA
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Employee Retirement Income Security Act 1974. Impose uniform national regulatory standards in place of varying state rules. Failed to create a meaningful alternative national oversight scheme. DOL administers some. ERISA limits ability of patients to sue administrator of employee sponsored health plan even with some medical decision making.
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Chapter 4 - Healthcare financing - Insurance - Medicaid
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50 million indigent or disabled Americans. Alleviates part of burden of uncompensated care that many hospitals would face. State-Federal waivers. Categorically needy (pregnant women and children).
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Chapter 4 - Healthcare financing - Insurance - Medicare
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40 million elderly and disabled Americans. Enforces clinical standards for hospitals, physicians, and other. Sets standards for physician training and determines what products/services are reimbursed.
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Chapter 4 - Healthcare financing - Insurance - Step 2 - FEHBP
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Federal Employee Health Benefit Plan - sets standards for fed employees and influences policies sold in private market. Provide employee with set financial contribution and employees supplement toward ins plan. Administered by US Office of Personnel Management sets criteria for participation.
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Chapter 4 - Healthcare financing - Insurance - State Insurance
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Regulations help to determine availability of insurance that employers can offer to workers.
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Chapter 4 - Healthcare financing - Insurance - Medicaid - QMB & SLIMB Buy-in
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Medicare Buy-In Program,(Qualified Medicare Beneficiary) and(Specified Low-Income Medicare Beneficiary). Designed to protect low-income Medicare beneficiaries from costs required to receive Medicare coverage (out-of-pocket cost-deductibles and co--payments). Connects Medicare and Medicaid, as Medicaid pays for all or part of the Medicare premium and deductible amounts for individuals who are financially eligible. Qualified Medicare Beneficiary Program serves individuals with modest assets with combined incomes not over 100 percent of the FPL. Medicaid program pays Medicare Part B premiums and cost-sharing amounts. Specified Low-Income Medicare Beneficiary Program pays Part B premium for incomes between 100 and 120% of poverty.
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Chapter 4 - Healthcare financing - Insurance - Medicaid - SCHIP
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Combined federal oversight and funding with administration as separate program by state. Federal funding under matching formula more generous than medicaid family income up to 200% of poverty level. Requirements min level coverage, limit on premiums charged, deductible and copay restrictions. Not entitlement because of fixed fed contribution.
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Chapter 4 - Healthcare financing - Insurance - Medicaid - ESRD
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Early Medicare coverage expansion - End-Stage Renal Disease. Coverage for kidney dialysis (cleans toxins from blood of patients whose kidneys no longer function) to treat ESRD. Range of beneficiaries - any age. Resolved dilemma giving coverage to all who need it.
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Chapter 4 - Healthcare financing - Insurance - Medicare - Parts A, B, C, D
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Federal. A - covers hospital expenses for anyone over 65, totally disable and ESRD. B - covers physician and outpatient services for same people with premium. C - (Medicare Advantage) coverage for inpatient and outpatient services to receive benefits through private MC plans. D - Prescription drugs w/premium.
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Chapter 5 - Regulation of Drugs and Healthcare Products - Intro
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Peter Collier - USDAs chief chemist issued first call for national food and drug law and was defeated.
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Chapter 5 - Regulation of Drugs and Healthcare Products - FDA Structure - Pure Food and Drug Act 1906
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1906 As result of Upton Sinclair's "The Jungle" exposing dangerous and unsanitary conditions in meat packing industry. T. Roosevelt enacted with companion law same day - The Meat Inspection Act. Prohibited "adulteration and misbranding of foods and drugs." Required ingredients to be listed on food and dangerous ingredients listed on drugs. False and misleading was now illegal.
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Chapter 5 - Regulation of Drugs and Healthcare Products - FDA Structure - Shirley Amendment
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1912 - Prohibited false therapeutic claims intended to defraud consumer because of US vs Johnson (Supreme Court ruled Pure Food and Drug only applied to statements of composition of drug, not false claims).
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Chapter 5 - Regulation of Drugs and Healthcare Products - FDA Structure - Food, Drug, and Cosmetic Act
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1938 - Pre-market safety and testing including phases of trials. Result of elixir of sulfanilamide, antibiotic preparation for kids, not tested for toxicity because it wasn't part of regulation. Act revamped oversight of foods and drugs.
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Chapter 5 - Regulation of Drugs and Healthcare Products - FDA Structure - Food, Drug, and Cosmetic Act - What were part of new regulation?
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Procedures for review of safety of new drug before market, extension of FDAs scope of authority to include cosmetics and therapeutic devices, elimination of requirements that gov't prove fraud to prosecute false claims, authority to inspect factories.
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Chapter 5 - Regulation of Drugs and Healthcare Products - FDA Structure - Food Additives Amendment
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1958 (Delaney Clause) - banned the use of any carcinogenic substance as a food additive regardless of dose. Extended in 1960-any amount of a carcinogen was banned regardless of its strength with no discretion for regulators.
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Chapter 5 - Regulation of Drugs and Healthcare Products - FDA Structure - Vaccine and Biological from NIH
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1972-Congress transferred to FDA from NIH regulatory authority over vaccines, blood products, other biologics giving responsibility for issuing licenses to manufactures and suppliers. 1973 - CPSC (Consumer Product Safety Commission) regulate safety of consumer products.
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Chapter 5 - Regulation of Drugs and Healthcare Products - FDA Structure - Patents
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Patents allow drug companies to recoup their costs and earn profit on investment. Prohibits anyone other than patent holder from making or selling product for 20 years from date of filing. (Forbids market competition temporarily).
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Chapter 5 - Regulation of Drugs and Healthcare Products - FDA Structure - Orphan Drugs Act
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1983-Act to create incentives to induce manufacturers to develop drugs to treat rare diseases. Authorized grants, tax credits, 7 years of additional patent to treat rare diseases. Later amended to specifically define orphan drug (affects 200,00 people or less).
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Chapter 5 - Regulation of Drugs and Healthcare Products - FDA Structure - Nutrition Labeling and Education Act and Save Medical Devices Act
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1990-Required all food packages include nutrition info and standardize use of labeling terms with health implications "low fat" or "light." Institutions that use medical devices report problems to FDA giving agency new authority to order recalls. Manufacturers required to conduct postmarket surveillance and system to locate buyers if recall.
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Chapter 5 - Regulation of Drugs and Healthcare Products - FDA Structure - PDUFA
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Prescription Drug User Fee Act 1992-5 year pilot-Sought to speed process at Manufacturers expense. Set new limits on FDA to complete its reviews of NDAs. Agency directed to hire more reviewers. Raised concern of too speedy to assess all risks.
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Chapter 5 - Regulation of Drugs and Healthcare Products - FDA Structure - FDA Modernization Act
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1997-reauthorized PDUFA as part of Act. Accelerated review of medical devices, paralleling with drugs and important changes to oversight of pharmaceutical marketing. Softened food regulation.
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Chapter 5 - Regulation of Drugs and Healthcare Products - FDA Structure - Reimportation
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US only industrialized country not regulating drug prices. Prices for generic drugs in US are higher. Once drugs leave US, no longer subject to FDA oversight (not able to assure drugs weren't mishandled). Canada most common.
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Chapter 5 - Regulation of Drugs and Healthcare Products - FDA Structure - EPA
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Founded in 1970-regulates safety and effectiveness of pesticides. Sets tolerance levels for pesticide residues in foods. Sets national standards for drinking water.
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Chapter 6 - Public Health - History
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Half of Diphtheria patients at hospital in NYC were misdiagnosed. First state health agency-New Orleans. First permanent state health board-Massachusetts. Congress gave Marina Hospital Service authority to quarantine ships because of cholera and yellow fever.
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Chapter 6 - Public Health - Focus on nutrition and various nutrition programs
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Hazard Analysis and Critical Control Point Program-regulations addressing animal feed, uncontaminated water in food processing, food preservatives, sanitation in equipment, surveillance of food handling. Milk Sanitation Program-interstate shipment of Grade A Milk. 1930s food relief and school feeding programs. 1930s Pellagra-Niacin deficiency.
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Chapter 6 - Public Health - Focus on chronic disease
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Over time-cancer, neurological disorders, diabetes-lead to progressive deterioration of physiological functions. Cancer-exposure to array of toxic substances. 1964-link between cigarettes and lung cancer. CDC include research into chronic disease. Leukemia, and birth effects. Air quality, asbestos, lead based paint, vinyl chloride exposure. CDC and Prevention. High fat consumption and obesity.
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Chapter 6 - Public Health - Environment-EPA, CERCLA, ATSDR
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EPA 1970-limit exposures to environmental hazards that pose long term health risks. National Environmental Protection Act-environmental impact assessments. Clean Water Act-standards set for emissions into air from smokestacks, auto, etc. Resource Conservations and Recovery Act-issue permits for operation of waste disposals. Comprehensive Environmental Response Compensation and Liability Act "Superfund"-national effort to identify and clean toxic wastes. Agency for Toxic Substances and Disease Registry-prevent exposures and illnesses from haz substances and monitors exposures and related disease.
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Chapter 6 - Public Health - Workplace-OSHA
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Occupational Safety and Health Administration 1970. Benzene, lead, polyvinyl chloride linked to various forms of cancer. OSHA set its own exposure standards different from EPA.
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Chapter 6 - Public Health - Mental health/MH Parity-SAMHSA
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Separate patients from society than treat. Psychotheraphy for milder conditions. Severe mental health-institutionalized. 1950s-medications to treat symptoms of Schizophrenia, depression, and severe anxiety. Mental Retardation Facilities and Community Mental Health Centers Construction Act-construct facilities. Substance Abuse and Mental Health Services Admin.-admin of grants to states that support community based treatment programs. (CMHS)Center for Mental Health Services, (CSAP)Center for Substance Abuse Prevention, (CSAT)Center for Substance Abuse Treatment, (OAS)Office of Applied Studies.
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Chapter 6 - Public Health-Federal agencies-CDC, HRSA, EPA, FNS, USDA, DHS
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CDC-Promote Health and quality of life by preventing and controlling disease, injury, and disability. Health Resources and Service Administration-providing health care resources for medically underserved populations. DHS-coordinate protection of American citizens within country's borders.
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Chapter 7 - Business Relationships - Standard Accounting Practices-Sarbanes Oxley Act
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S-O Act-Imposes standards for accounting practices.
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Chapter 7 - Business Relationships - Fraud and Abuse in Billing
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OIG-Office of Inspector General-gathers suspected violations-audits of health care providers look for instances of fraud in billing or illegal financial arrangements. Medicare/Medicaid. Arrangements between physicians and hospitals, common services, rental and referral arrangements.
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Chapter 7 - Business Relationships - Non profit/Tax exempt status
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Tax exempt status requires approval from revenue authorities at several levels, hospital must serve charitable mission that benefits community (amount of uncompensated care), community outreach and public health efforts.
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Chapter 7 - Business Relationships - Anti-Trust/Anti-competition-Sherman Act 1890, FTC Act & Clayton Act 1914.
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1-negotiations between payers and providers. 2-limit size to which provider networks can grow. 3-composition of organizations that combine physician practices. 4-operations of organizations through which physicians regulate their own profession.
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