Government, Ethics and Law

"...the man who really counts in the world is the doer, not the mere critic-the man who actually does the work, even if roughly and imperfectly, not the man who only talks or writes about how it ought to be done." (T. Roosevelt,1891)

"Criticism is necessary and useful; it is often indispensable; but it can never take the place of action, or be even a poor substitute for it. The function of the mere critic is of very subordinate usefulness. It is the doer of deeds who actually counts in the battle for life, and not the man who looks on and says how the fight ought to be fought, without himself sharing the stress and the danger."

(T. Roosevelt,1894)

"It is not the critic who counts: not the man who points out how the strong man stumbles or where the doer of deeds could have done better. The credit belongs to the man who is actually in the arena, whose face is marred by dust and sweat and blood, who strives valiantly, who errs and comes up short again and again, because there is no effort without error or shortcoming, but who knows the great enthusiasms, the great devotions, who spends himself for a worthy cause; who, at the best, knows, in the end, the triumph of high achievement, and who, at the worst, if he fails, at least he fails while daring greatly, so that his place shall never be with those cold and timid souls who knew neither victory nor defeat."

Theodore Roosevelt"Citizenship in a Republic,"Speech at the Sorbonne, Paris, April 23, 1910

XIV Amendment to the U.S. Constitution 1868

Section 1. All persons born or naturalized in the United States, and subject to the jurisdiction thereof, are citizens of the United States and the state wherein they reside. No state shall make or enforce any law which shall abridge the privileges or immunities of citizens of the United States; nor shall any state deprive any person of life, liberty, or property, without due process of law; nor deny to any person within its jurisdiction the equal protection of the laws.

Section5. The Congress shall have powers to enforce, by appropriate legislation, the provisions of this article.

Civil Rights Act -- 1964--Title VI: prohibits the practice of racial discrimination by any organization or agency receiving money under any program supported by the Department of Health and Human Services.

--Includes all “providers of service” receiving federal funds under Medicare legislation.

--No discrimination or segregation on the basis of race, color, religion, or national origin

Sherman Antitrust Act--1890

• Every contract, combination in the form of trust or otherwise, or conspiracy, in restraint of trade or commerce among the several states is declared to be illegal.

• Caveat: limiting the number of physicians with privileges can be a violation of this act.

Privacy Act--1974

• Safeguards individual privacy from the misuse of federal records.

• Gives individuals access to records concerning themselves that are maintained by federal agencies. (FOIA)

• Established the Privacy Protection Safety Commission.

Emergency Medical Treatment and Active Labor Act--1986

• If a hospital has an emergency department it must provide for an appropriate medical screening examination within the capability of the hospital emergency department, including ancillary services routinely available to the emergency department.

EvaluateEmergency TreatmentStabilizeTransport?

Burditt v. U.S. Department of Health and Human Services

• P. 185• Woman in active labor with ruptured

membranes and high bp (210/130) was transferred to another hospital 170 miles away.

• What are the main issues in this case?• What ethical theories and principles and

values are of concern?• ---------

Health Care Quality Improvement Act -- 1986

• Gives limited immunity:– to persons giving information to professional

review bodies – and those assisting in review activities

• Purpose: to facilitate the frank exchange of information among professional conducting peer review inquiries without fear of reprisals in civil lawsuits.

Agency for “Heatlhcare Research and Quality (AHRQ)

• Established 1989 and charged with research designed to:– Improve quality of health care– Reduce costs– Broaden access to essential services

Ethics in Patient Referral Act--1989

• Prohibits physicians who have ownership interest or compensation arrangements with a clinical laboratory from referring Medicare patients to that laboratory.

Patient Self-Determination Act—1990(PSDA)

• Enacted to ensure that patients are informed of their rights to execute advanced directives and accept or refuse medical care.

• Applies to:– Hospitals– Skilled nursing facitilies– Home health agencies– Hospice organizations– HMOs

PSDA

• Written information

• Written policies

• Documented in the medical record

• Nondiscrimination

• Ensure compliance with state law

• Provide education of staff and the community

Health Insurance Portability & Accountability Act (HIPAA)

Kennedy-Kassebaum Bill

Public Law 104-191

Signed by Clinton 1996

Health Insurance Portability & Accountability Act of 1996 (P.L. 104-191

Title I: Insurance Portability

Title II: Administrative Simplification

Title III: Medical Savings & Tax Deduction

Title IV: Group Health Plan Provisions

Title V: Revenue Offset Provisions

Objectives of HIPAA

1. Improving portability of health insurance

2. Combating waste, fraud, and abuse in health care

3. Promoting the use of medical savings accounts

4. Simplifying the administration of health insurance

HIPAA Administration Simplification

1. Standardized data sets for electronic health care transactions

2. Unique identifying codes for health care providers, Health plans, employers, and individuals

3. Security of electronic health information4. Privacy of individually identifiable health

information5. Enforcement of the administrative

simplification provisions

(Covered entities)Three entities directly regulated by

the privacy rules:1. Health Care Providers using EDI

2. Health Plans

3. Health Care Clearinghouses

Health Care Provider

• A provider of medical or health services

• Any other person or organization who – Furnishes– Bills– Is paid

for healthcare in the normal course of business.

Disclosure to vendors (business associates)

• Vendors that use PHI to provide a service to a covered entity (CE) are know a “BA”

• A “BA” is a legal entity, not under the direct control of the CE that creates, transmits, receives or maintains PHI on behalf of a CE. (billing, transcriptionists, practice mgmt, software vendors)

Covered entity (HCP)if it transmits health information in an

electronic format in the following:

• Health care claims or equivalent encounter information;

• Health care payment and remittance advice;

• Coordination of benefits;• Health care claim status;• Enrollment and

disenrollment of a health plan

• Eligibility for a health plan

• Health plan premium payments;

• Referral certification and authorization;

• First report of injury• Health claims

attachments; and • Other transactions that

the Secretary may further prescribe by regulation.

“Health Plan”provides for or pays for cost of medical

care.• A group health plan• A health insurance issuer• An HMO• The Medicare Program• The Medicaid Program (and the State agency

that administers Medicaid)• A Medicare supplemental policy issuer• An employee welfare benefit plan or any other

arrangement that offers health benefits to employees of two or more employers.

“Health Plan”provides for or pays for cost of medical

care. (Con’t)• The health program for active military personnel• The veterans health program• The CHAMPUS program (TRICARE)• The Indian Health Service program• The Federal Employees Health Benefits

Program• Certain state child health assistance plans• The Medicare +Choice Program• A high risk pool established under state law

Health Care Clearinghouses

• Billing service• Repricing companies• A community health management information

system• “value-added” networks and switchesWho either process of facilitate the processing of

health info received from one entity in a nonstandard format into a standard format; or vice versa.

New rights granted individuals under privacy rules.

• The right to request an accounting of health information disclosures

• The right to request an amendment to their health information

• The right to inspect and copy their health information• The right to receive confidential communications

about their health information• The right to request restriction on uses or disclosures• The right to complain to the covered entity and to the

Secretary of the Department of Health and Human Services

Responsibility for Enforcement

• Privacy Standard– Office for Civil Rights, Dept, HHS

• TCS & Security Standard– Center of Medicare and Medicaid Services

Civil Penalties

• Up to $100 per person per violation and not more than $25,000 per person for violations of a single standard for a calendar year.

Criminal Penalties

• Up to $50,000 fine and /or imprisonment for up to one (1) year for knowingly using protected health information inappropriately;

• Up to $100,000 fine and/or imprisonment for up to five (5) years for inappropriately accessing protected health information under “false pretenses”; and

• Up to $250,000 fine and/up to ten (10) years imprisonment for inappropriately accessing protected health information for “commercial advantage” or to do malicious harm.

Individually identifiable health information

“protected health information” • Created or received by a health care provider,

health plan, employer, or health care clearinghouse; and

• Relates to the past, present, or future physical or mental health or condition of an individual, the provision of health care to an individual; or the past, present, or future payment for the provision of health to an individual; and that:– Identifies the individual; or– In which there is a reasonable basis to believe that

the information can be used to identify the individual.

Disclosure w/o written authorization

1. Uses and disclosures required by law.

2. Treatment, payment, and operations

3. Uses and disclosures for public health activities

4. Disclosures about victims of abuse, neglect, or domestic violence

5. Uses and disclosures for health oversight activities

6. Disclosures for judicial and administrative proceedings

7. Disclosures for law enforcement purposes

8. Uses and disclosures about decedents

Disclosure w/o written authorization

9. Uses and disclosures for cadaveric organ, eye, or tissue donation purposes

10. Uses and disclosure for research purposes

11. Uses and disclosures to avert a serious threat to health or safety

12. Uses and disclosures for specialized government functions, and

13. Disclosures for workers’ compensation

De-identifying PHI

1. Name

2. All address info

3. All elements of dates (except year) for dates…birth, admission, discharge, date of death, etc.

4. Telephone numbers

5. Fax numbers

6. E-mail addresses

7. SSN

8. Medical record numbers

9. Vehicle identifiers

10. Device identifiers

11. URLs

12. IP addresses

13. Biometric identifiers

14. Facial photographs

15. Any other unique identifying number, characteristic, or code

Political Malpractice?

43 million uninsured?

Hillary-Care, the Sequel Mass. Gov. Romney's health care plan says everyone pays

Number: 43 million Americans have no health insurance coverage for some time.Chronically Uninsured: 21 to 31 million people are “chronically uninsured” -- defined as being without insurance for an entire year.Working Families: A substantial majority of the 43 million uninsured (60 percent or 26 million people) are employed but lack health insurance coverage. A significant number of additional dependents are in the family of an uninsured employee who does not have employer-sponsored coverage. Low Income: More than half (23.5 million, or 54 percent) of the uninsured have a household income below 200 percent of the federal poverty level.Small Business: More than 60 percent of uninsured workers are self-employed or employed by firms with less than 100 employees.Immigrants: Immigrants and their U.S.-born children represent more than 90 percent of the increase in the uninsured population since 1989. Hispanics: Among low-income individuals, Hispanics had the highest rates and the longest duration of uninsurance (23 percent lacked insurance for more than 24 months). Children: Of the 8.5 million uninsured children under 18 years old, 4 million of them are eligible for but not enrolled in public programs.Young Adults: Between 25 and 30 percent of people aged 18 to 34 are uninsured.

Early Retirees: Fewer than 50 percent of all nonworking retirees age 55 or over have employment-based health insurance coverage.

http://republican.senate.gov/costcoveragecare/PDFs/WhoareUninsuredchart.pdf