Consent To Treat & Miscellaneous Issues (HCA 401) PDF

Unit Four Consent to Treat & Miscellaneous Issues HCA 401 EASTERN KENTUCKY UNIVERSITY Health HEALTH Care Administration SERVICES ADMINISTRATION Patient Consent Chapter 12  Why is it important to ensure that patients give consent...

Unit Four Consent to Treat & Miscellaneous Issues HCA 401 EASTERN KENTUCKY UNIVERSITY Health HEALTH Care Administration SERVICES ADMINISTRATION Patient Consent Chapter 12  Why is it important to ensure that patients give consent for treatment? HEALTH SERVICES ADMINISTRATION In your own words, explain the difference between “consent” and “informed consent”. HEALTH SERVICES ADMINISTRATION  Give an example of a situation in which informed consent may be not possible to obtain from a patient. HEALTH SERVICES ADMINISTRATION  _______________ Voluntary agreement by a person who possesses sufficient mental capacity to make an intelligent choice to allow something proposed by another to be performed on himself or herself. © 2014 Jones and Bartlett Publishers Health Services Administration  ____________________ Legal doctrine where a patient has right to know potential risks, benefits, & alternatives of a proposed procedure. Patient has absolute right to know about & select from available treatment options. © 2014 Jones and Bartlett Publishers Health Services Administration  Forms of Consent Express consent Implied Consent Generally be presumed when immediate action is required to prevent death or permanent impairment of a patient’s health e.g., treatment of accident victim © 2014 Jones and Bartlett Publishers Health Services Administration Forms of Consent - II Statutory Consent Many states have adopted legislation allowing for emergency care. Judicial Consent Allowed when there is concern as to the absence or legality of consent. Health Services Administration Informed Consent Discussion between a _____________ patient and the treating physician Content: Why the procedure or treatment is being recommended What are the alternative treatments available What are the benefits, risks, and complications of the recommended different treatment options Health Services Administration  Physicians Informed Consent Informed consent is predicated on duty of the physician to disclose sufficient info to enable patient to evaluate proposed medical or surgical procedures before submitting to them. Physicians expected disclose risks, benefits, & alternatives of recommended procedures. Disclosure: what a reasonable person would consider material to a decision of whether to or not to undergo treatment. © 2014 Jones and Bartlett Publishers Health Services Administration  Nurses Informed Consent Nurses most cases have no duty to advise a patient as to a surgical procedure to be employed may confirm physician has explained the procedure witness patient’s signature on consent form © 2014 Jones and Bartlett Publishers Health Services Administration  Hospitals Informed Consent Not generally responsible for informing patients as to the risks, benefits and alternatives. Some cases in which hospitals have a duty CT Scans MRI Imaging © 2014 Jones and Bartlett Publishers Health Services Administration  Patients Informed Consent Patient's ability to: understand risks, benefits, & alternatives evaluate info provided by the physician express his or her treatment preferences voluntarily make decisions regarding his or her treatment plan © 2014 Jones and Bartlett Publishers Health Services Administration Informed Consent Why is this important? Henrietta Lacks Tuskegee Syphilis Study Nazi experiments …..and any more! Health Services Administration  CASE: Course of Treatment: Patient’s Decision Elderly woman living alone fell & fractured her hip. An orthopedic surgeon reviewed the patient's condition & decided that rather than utilizing a pinning procedure for her hip, it would be better to adopt a conservative course of treatment, bed rest. © 2014 Jones and Bartlett Publishers Health Services Administration  CASE: Course of Treatment: Patient’s Decision – II Prior to her injury, plaintiff maintained an independent style of living. Expert testimony at trial indicated that bed rest was an inappropriate treatment. Was the patient successful for not being informed as to alternatives courses of treatment? © 2014 Jones and Bartlett Publishers Health Services Administration  CASE: Lack of Consent Patient had multiple medical diagnoses. Her physician, Dr. Sottiurai, ordered bilateral arteriograms to determine cause of the patient's impaired circulation. De La Ronde Hospital could not accommodate Sottiurai's request & patient was transferred to Dr. Lang, a radiologist at St. Jude Hospital. © 2014 Jones and Bartlett Publishers Health Services Administration  CASE: Lack of Consent – II Lang performed a femoral arteriogram, not the bilateral brachial arteriogram ordered by Sottiurai. The patient was prepared for transfer back to De La Ronde Hospital. Shortly after the ambulance departed, patient suffered a seizure in the ambulance & was returned to St. Jude. Riser's condition deteriorated & died 11 days later. What did the trial court determine? © 2014 Jones and Bartlett Publishers Health Services Administration  CASE: Trial Court Decision The district court ruled for the plaintiffs, awarding damages in the amount of $50,000 for Riser's pain and suffering and $100,000 to each child. Lang appealed. On appeal, what did the appeals court determine? © 2014 Jones and Bartlett Publishers Health Services Administration  Information to be Disclosed Physician should provide as much information about treatment options as necessary based on a patient's personal understanding of physician's explanation of risks of treatment & probable consequences of treatment. Needs of each patient can vary depending on age, maturity, & mental status. © 2014 Jones and Bartlett Publishers Health Services Administration  Information to be Disclosed – II Individual responsible for obtaining consent must weigh importance of giving full disclosure to the patient against likelihood such disclosure will adversely affect the patient’s decision. © 2014 Jones and Bartlett Publishers Health Services Administration  Information to be Disclosed – III Courts generally utilize an "objective" or "subjective" test to determine if a patient would have refused treatment if the physician had provided adequate information as to the risks, benefits, & alternatives of the procedure. © 2014 Jones and Bartlett Publishers Health Services Administration  Subjective test Relies on credibility of the patient’s testimony Patients must testify & prove they would not have consented to the procedure(s) had they been advised of the risks. © 2014 Jones and Bartlett Publishers Health Services Administration  Objective Test Take into account characteristics of the plaintiff idiosyncrasies, fears, age, medical condition, and religious belief Must show that a “reasonable person” would not have undergone a procedure if properly informed. © 2014 Jones and Bartlett Publishers Health Services Administration Assessing Decision-Making Capacity 1. Patient understands risks, benefits, & alternatives of a proposed test or procedure 2. Patient evaluates the information provided by the physician. 3. Patient expresses his/her treatment preferences 4. Patient Voluntarily makes decisions regarding his or her treatment plan without undue influence (e.g., family, medical personnel) Health Services Administration  Adequacy of Consent Patient: understand risks, benefits, & alternatives evaluates the information provided expresses treatment preferences voluntarily makes decisions regarding treatment plan © 2014 Jones and Bartlett Publishers Health Services Administration ______________________ As binding as written consent. More difficult to corroborate. Health Services Administration  Written Consent Describes Nature of the patient’s illness Procedure consented to Risks & probable consequences of the procedure Probability that the proposed procedure will be successful © 2014 Jones and Bartlett Publishers Health Services Administration  Written Consent Describes – II Alternative methods of treatment Associated risks & benefits of each Indication the patient understands nature of proposed treatment Signatures dated & signed © 2014 Jones and Bartlett Publishers Health Services Administration  Special Forms of Consent Admission Consent Consent for Routine Procedures Consent for Specific Procedures Implied Consent Statutory Consent Judicial Consent © 2014 Jones and Bartlett Publishers Health Services Administration _________________ Patient does not explicitly give consent through words (verbally) Patient seems agreeable through his/her actions Nods head, shows up at agreed upon time for procedure, etc. Why? Patient cannot provide verbal consent Patient refuses to give verbal consent Emergency situations Provider can treat patient without gaining consent It is assumed that the patient would want life-saving measures to be taken. Health Services Administration  _________________ Consent generally assumed Ambulance Care Good Samaritan Statutes Emergency Departments When patient clinically unable to give consent © 2014 Jones and Bartlett Publishers Health Services Administration  _________________ May be periodically necessary When alternatives exhausted 2nd opinions by consulting physicians helpful On-call legal advice should be sought © 2014 Jones and Bartlett Publishers Health Services Administration  Who May Consent Competent patients Guardianship Parental Consent Emancipated Minor © 2014 Jones and Bartlett Publishers Health Services Administration INCOMPETENT PATIENTS Ability to consent to treatment is a question of fact. When a physician doubts a patient’s capacity to consent, even though the patient has not been judged legally incompetent, the consent of the nearest relative should be obtained. Health Services Administration LIMITED POWER OF ATTORNEY Parental authority to have, for example, school officials & camp counselors to act on a parents’ or legal guardian’s behalf when seeking emergency care. Such consent for treatment provides limited protection in the care of a particular child. Health Services Administration  Refusal of Treatment For any or no reason Mere whim Refusal of Treatment: Religious Beliefs © 2014 Jones and Bartlett Publishers Health Services Administration  Discharge Against Medical Advice Completed release provides documented evidence of a patient's refusal to consent to a recommended treatment. Refusal to consent to treatment. Release form should be executed. Discharge/Leaving Against Medical Advice Note if patient refuses to sign release. © 2014 Jones and Bartlett Publishers Health Services Administration When in Doubt Error on the Side of Life Health Services Administration  Informed Consent Defenses Risk not disclosed is commonly known. Patent did not want to know about the risks. Consent not reasonably possible. Physician disclosed what he considerable reasonable © 2014 Jones and Bartlett Publishers Health Services Administration  Ethics: Informed Consent _______________________ Informed consent protects the basic right of the patient to make the ultimate informed decision regarding the course of treatment to which he or she knowledgeably consents. Consent forms should be used as a supplement to the oral disclosure of risks, benefits, and alternatives to the proposed procedure that a physician normally gives. © 2014 Jones and Bartlett Publishers Health Services Administration Procreation and Ethical Dilemmas Chapter 15 Abortion Premature termination of pregnancy. It can be classified as spontaneous or induced. It may occur as an incidental result of a medical procedure or it may be an elective decision on the part of the patient. Health Services Administration Right to Abortion Roe v. Wade – 1973 First Trimester abortion decision between woman & physician. Second Trimester state may reasonably regulate abortion procedure. Third Trimester state may prohibit all abortions except those deemed necessary to protect maternal life or health. Health Services Administration Abortion Committee Requirement Doe v. Bolton – 1973 To Restrictive Requirements struck down residency performance of abortion by Joint Commission approved hospital approval of abortion by a medical staff committee consultations Health Services Administration Abortion Funding Not Required for Elective Abortions In Beal v. Doe, 1977 Court ruled that it is not inconsistent with the Medicaid portion of the Social Security Act to refuse to fund unnecessary medical services. Maher v. Roe Supreme Court voted 6 to 3 states may refuse to spend public funds to provide non-therapeutic abortions. Not Required for Therapeutic Abortions Health Services Administration Funding Bans Unconstitutional in California If the state cannot directly prohibit a woman's right to obtain an abortion, may the state by discriminatory financing indirectly nullify that constitutional right? Can the state tell an indigent person that the state will provide him with welfare benefits only upon the condition that he join a designated political party or subscribe to a particular newspaper that is favored by the government? Health Services Administration Funding Bans Unconstitutional in California Can the state tell a poor woman that it will pay for her needed medical care but only if she gives up her constitutional right to choose whether or not to have a child? Health Services Administration Discrimination in Funding Prohibited Simat Corp. v. Arizona Health Care Cost Containment Sys. The Arizona Supreme Court in Simat Corp. v. Arizona Health Care Cost Containment Sys., found that the state's constitution does not permit the state & the Arizona Health Care Cost Containment System to refuse to fund medically necessary abortion procedures for pregnant women suffering from serious illness while, at the same time, funding such procedures for victims of rape or incest or when the abortion was necessary to save the woman's life. Health Services Administration States May Protect Viable Fetus Colauti v. Franklin 1979 The Supreme Court in Colautti v. Franklin voted 6 to 3 that states may seek to protect a fetus that a physician has determined could survive outside the womb. Determination of whether a particular fetus is viable must be a matter for judgment of the physician. Health Services Administration Overturning of Roe v. Wade – 1973 Dobbs v. Jackson Women’s Health Organization - 2022 U.S. Supreme Court overturned 50 years of precedent, overruling Roe v. Wade The Supreme Court gave states total leeway to restrict abortion or prohibit it altogether. Health Services Administration Consent – I Missouri: Parental Consent Statute Ruled Unconstitutional Massachusetts: Parental Consent Statute Ruled Unconstitutional Utah: Notifying Parent for Immature Minor Constitutional Consent Not Required for Emancipated Minor Health Services Administration Consent – II Parental Notification Not Required Minor’s Decision to Abort Found Sufficient Abortion Case Returned to Lower Court Minor’s Decision to Abort Not Sufficient State Interest Not Compelling Health Services Administration Consent – III Spousal Consent Requirement Unconstitutional Father of Unborn Fetus Could Not Stop Abortion Spousal Consent Undue Burden Health Services Administration Parental Consent Bellotti v. Baird – 1979 Parental consent requirement struck down. MA statute too restrictive. statute as written & construed, no minor, no matter how mature & capable of informed decision making, could receive an abortion without the consent of either both parents or a superior court judge, making minor's abortion subject in every instance to an absolute third-party veto. Health Services Administration Parental Notification Not Req’d Planned Parenthood v. Owens – 2000 Colorado Parental Notification Act, Colo. Rev. Stat. § § 12- 37.5-101, et seq. (1998), which required physician to notify parents of a minor prior to performing an abortion upon her, violates minor's rights protected by the U.S. Constitution. The act generally prohibited physicians from performing abortions on an unemancipated minor until at least 48 hours after written notice has been delivered to minor's parent, guardian, or foster parent. Health Services Administration Immature Minors H.L. Matheson 1981 Statute requiring physician to notify parents of minor, when possible, upheld. Parental notice does not violate constitutional rights of immature, dependent minor. State may not, however, legislate a blanket un-reviewable power of parents to veto their daughter’s abortion. Health Services Administration Emancipated Minors In re Anonymous – 1987 Consent Not Required for Emancipated Minor. Health Services Administration Spousal Consent Not Required Doe v. Zimmerman – 1975 Provisions Pennsylvania Abortion Control Act requiring written consent of the husband unconstitutional. Provisions impermissibly permitted husband to withhold his consent either because of his interest in potential life of the fetus or for capricious reasons. Although father's interest in the fetus was legitimate, it did not outweigh the mother's constitutionally protected right to an abortion. Health Services Administration Abortion Rights Reaffirmed Planned Parenthood v. Casey – 1992 Restricting Right to Abortion Affirmed right of women to have an abortion. State’s power to restrict abortions after fetal viability. principle that state has legitimate interests in protecting woman & life of fetus. Health Services Administration Abortion Rights Reaffirmed Casey, con’t - 1992 Undue burden to require spousal notification Not undue burden to require: informed consent of nature of abortion procedure & risks involved. informed consent be provided before abortion information be provided on the fetus & alternatives to abortion parental consent be given a minor seeking abortion, providing for judicial bypass option 24-hour waiting period before any abortion can be performed. Health Services Administration Abortion Counseling City of Akron v. Akron Center – 1983 Physician Counseling of Patient Upheld States cannot mandate what information physicians provide abortion patients. Hospital deliveries States cannot mandate that abortions for women over 3 months pregnant be performed in hospital. Health Services Administration Prohibition Abortion Counseling Rust Sullivan – 1991 Regulations prohibiting abortion counseling & referral by family planning clinics that receive funds under Title X were held to be constitutional. Health Services Administration 24-Hour Waiting Period Not Burdensome State may place some restrictions on previability abortions. Restrictions must not impose an “undue burden” on woman. Health Services Administration Incompetent Persons An abortion was found to have been proper by a family court in In re Doe April 5, 1994 for retarded woman court properly chose welfare agencies as guardian mother apparently had little contact with her daughter Health Services Administration Viability Test Required Webster v. Reproductive – 1989 Statute upheld providing that no public facilities or employees should be used to perform abortions. Physicians should conduct viability tests before performing abortion. Health Services Administration Partial Birth Abortion – I D&E Ban Constitutionally Vague Women’s Medical Professional Corp. v. Voinovich Partial-Birth Abortion Ban Act Unconstitutional Little Rock Family Planning Services v. Jegley Partial-Birth Abortion Statute Vague Planned Parenthood of Cent. N.J. v. Farmer Health Services Administration Partial Birth Abortion II Partial-Birth Abortion: Ban Unconstitutional 2002 Stenberg v. Carhart ban lacked an exception to protect the health of the mother 2003: President Bush signs federal restrictions banning late term abortions. Health Services Administration Partial Birth Abortion – III 2005 Partial-Birth Abortion Act 2005: Bush administration asked the Supreme Court to review an appellate court's decision holding the Partial Birth Abortion Act of 2003 unconstitutional. 2006: U.S. Supreme Court Justices heard oral arguments on November 8 in what may be two of the most significant abortion rights cases in decades. The dispute involves Congress’s ban on partial birth abortion. Health Services Administration Partial Birth Abortion – IV Partial-Birth Abortion Act: First Federal Restrictions 2006 National Abortion Federation v. Gonzages ban lacked an exception to preserve health of mother Health Services Administration Continuing Controversy Physician Concern Antiabortion Demonstrations Obstructing Access to Abortion Clinics Health Services Administration Abortion & Conflicting Beliefs Two or more ethical principles in conflict with one another considered “ethical dilemmas. Morality of Abortion not a legal or constitutional issue matter of philosophy, ethics, & theology subject where reasonable people can, and do, adhere to vastly divergent convictions and principles Obligation to define liberty of all not to dictate our own moral code. Health Services Administration Sterilization Termination of the ability to produce offspring Elective Sterilization Regulation of Sterilization for Convenience Therapeutic Sterilization Involuntary/Eugenic Sterilization Health Services Administration Artificial Insemination Injection of seminal fluid into a woman to induce pregnancy, takes place outside of the woman’s Homologous artificial insemination Heterologous artificial insemination Consent Required Confidentiality must be maintained Health Services Administration Surrogacy Method of reproduction whereby a woman agrees to give birth to a child she will not raise but hand over to a contracted party Surrogate may be the child’s genetic mother gestational carrier Health Services Administration Wrongful Birth, Life & Conception Wrongful Birth Wrongful Life Wrongful Conception Prevention of Lawsuits Health Services Administration End of Life Issues Chapter 16 Dreams of Immortality Human struggle to survive Desire to prevent & cure illness Advances in medicine & power to prolong life Process of dying can be prolonged Ethical & legal issues have increased involving entire life span, from right to be born to right to die Health Services Administration Scope of Ethical Issues Entire Life Span The Right to be Born The Right to Die, & Everything in between, e.g., to choose treatment to refuse treatment for oneself to refuse treatment for another to limit the suffering one would endure Health Services Administration ____________________ Right of a person to make one’s own decisions. Patient has right to accept or refuse care even if it is beneficial to saving his or her life. Autonomy may be inapplicable in certain cases affected by one’s disabilities, mental status, maturity, or capacity to make decisions. Health Services Administration Quinlan court Relying on: Roe v. Wade Announced the constitutional right to privacy protects a patient’s right to self-determination. State’s interest did not justify interference with her right to refuse treatment. Quinlan’s father was appointed her legal guardian Health Services Administration Cruzan Case Supreme Court held that right-to-die should be decided pursuant to state law, subject to a due-process liberty interest, and in keeping with state constitutional law. Cruzans returned to Missouri probate court: Judge Charles Teel authorized physicians to remove the feeding tubes from Nancy. testimony presented demonstrated clear & convincing evidence Nancy would not have wanted to live in a persistent vegetative state. Health Services Administration Legislative Response: _____________________of 1990 Requires healthcare organizations to explain to patients their legal right to direct their own care Right to refuse medical treatment Right to formulate advance directives Right to appoint surrogate decision-maker Federal reimbursement requires compliance with Act Health Services Administration Preservation of Life Medical ethics does not require patient’s life be preserved at all cost under all circumstances. Ethical integrity of a profession is not compromised by a patient’s decision to forego medical care. Right to body integrity. Health Services Administration _____________________ Mercy killing of hopelessly ill, injured or incapacitated Active intentional commission of an act, such as giving patient lethal drug Passive occurs when life-saving treatment (such as a respirator) is withdrawn or withheld Health Services Administration __________________________ Oregon’s Death with Dignity Act of 1994 physician-assisted suicide became a legal medical option for the terminally ill residents U.S. Supreme Court, in two unanimous & separate decisions, ruled laws in Washington & New York prohibiting assisted suicide are constitutional yet U.S. Supreme Court also ruled that states can allow doctors to assist in suicide of their terminally ill patients. Health Services Administration Advance Directives – I Making Preferences Known Obligation to make medical preferences known to treating physician. Any glimmer of uncertainty as to a patient's desires in an emergency situation should be resolved in favor of preserving life. Health Services Administration Advance Directives – II Living Will Health Care Proxy Determining Incapacity Agent’s Rights Durable Power of Attorney Guardianship Substituted Judgment Health Services Administration Kentucky Living Wills When are they activated? If serious illness or injury occurs AND Patient is unable to speak for himself As long as the patient is able to express his own decisions, the living will is not implemented. Who can have a living will in KY? Anyone over the age of 18 Note: ___________________________________ Health Services Administration Advanced Directives Examples of End-of-Life Treatments _____________ Do you want only CPR or can the doctor use a device? Mechanical Ventilation Do you want to be place on a mechanical ventilator? If yes, for how long? Tube Feeding Do you want to be placed on tube feeding? If yes, at what point in the situation? If yes, for how long? Health Services Administration Advanced Directives Examples of End-of-Life Treatments Antibiotics or Antivirals If you are near death and develop an infection, do you want the infection to be aggressively treated? Or, would you rather let the infection run its course? _______________ What do you want exactly? Die at home? Receive pain medications? Be fed ice chips to soothe dryness? Health Services Administration Advanced Directives Examples of End of Life Treatments Organ and Tissue Donations Do you want to be an organ donor? If yes, do you want to be kept alive temporarily until the procedure can be performed? _______________ Do you want to donate your body for scientific study? If so, which medical school or donation program have you selected? Health Services Administration Advanced Directives Creating a Living Will in KY Standard fill-in-the-box form Does not require an attorney, normally Page 1 of 3 Health Services Administration Advanced Directives Distributing the Living Will Keep the original in a safe, but easily accessible place Give a copy to your physicians Give a copy to a family member Give a copy to your health care surrogate Carry a wallet-sized card that indicates you have a living will Keep a copy with you when you travel Health Services Administration Advanced Directives Changing a Living Will Can change the directives at any time If you do, distribute new copies and destroy all old copies. Review the directives upon: Receiving a diagnosis of a terminal illness or one that will significantly alter your life Changing your marital status Changing your wishes (due to views of life) Health Services Administration Healthcare Proxies The person(s) who will make health care decisions for you should you become unable to make informed decisions for yourself Also Known As Health care agent Health care surrogate Durable power of attorney for health care Health Services Administration Healthcare Proxies Rights of Proxies Ability to consent for or refuse medical treatment Ability to employ or discharge medical providers Ability to access medical records Ability to direct the disposition of remains Ability to donate organs Ability to authorize an autopsy Health Services Administration KY HB 174 “MOST” Form Health Services Administration Futility of Treatment Physician recognizes effect of treatment will be of no benefit to the patient. Morally, a physician has a duty to inform patient when there is little likelihood of success. Determination as to futility of medical care is a scientific decision. Health Services Administration Withholding & Withdrawing Treatment – I Withholding of treatment decision not to initiate treatment or medical intervention for the patient. Withdrawal of treatment decision to discontinue treatment or medical interventions for the patient. Health Services Administration Withholding & Withdrawing Treatment - II When Patient in a terminal condition & there is reasonable expectation of imminent death. Patient a non-cognitive state with no reasonable possibility of regaining cognitive function. Restoration of cardiac function will last but for a brief period. Health Services Administration __________________ DNR orders written by a physician, indicate that in event of cardiac or respiratory arrest, no resuscitative measures should be used to revive patient. Health Services Administration Ethics Committee Committee offering objective counsel when facing difficult health care issues & decisions resource to patients, families, & staff. Includes wide range of community leaders. Analyzes ethical dilemmas, advise & educate health care providers, patients, & families. Assists patients & family in coming to consensus with options that best meet patient's care needs. Health Services Administration Ethics Committee Function Policy & procedure development Educational role Consultative role Political Advocacy Health Services Administration Autopsy Postmortem examinations to determine cause of death. Add to medical knowledge. Necessary for criminal activity or suspicious deaths. Deaths during surgery are reportable. Consent required. Health Services Administration Organ Donations – I Federal regulations hospitals to have, & implement, written protocols regarding organ procurement. notification duties concerning informing families of potential donors. Discretion & sensitivity in dealing with families. Health Services Administration Uniform Anatomical Gift Act 1968 Adopted by all 50 states Created an opt-in system for organ donation Individuals must make the choice to be part of the organ donation program on their own Revised in 2006 Permits the use of life support systems for the purpose of maximizing the organs suitable for transplant. Health Services Administration Organ Donations – II Education facilitate timely donation & transplantation Uniform Anatomical Gift Act allows a person to make a decision to donate organs at the time of death and allows potential donors. Health Services Administration Organ Donations – III Millions of people suffer from kidney disease, but in 2007 there were just 64,606 kidney-transplant operations in the entire world. In the U.S. alone, 83,000 people wait on the official kidney-transplant list. But just 16,500 people received a kidney transplant in 2008, while almost 5,000 died waiting for one. —Alex Tabarrok, The Wall Street Journal, January 8, 2010 Health Services Administration Research, Experimentation & Clinical Trials Combination of federal & state regulations Office of Research Integrity Institutional Review Board Informed Consent Duty to Warn Risks, benefits, alternatives Food & Drug Administration Health Services Administration Organ Human Genetics – I Study of inheritance as it occurs in human beings, includes stem cell research, clinical genetics (e.g., genetic disease markers) & molecular genetics. Genetic markers are genes or DNA sequences with a known location on a chromosome that can be used to identify specific cells & diseases individuals & species Health Services Administration Organ Human Genetics – II Genetic Information Nondiscrimination Act of 2008 prohibits discrimination on the basis of genetic information with respect to the availability of health insurance & employment employers from using an individual’s genetic information when making hiring, firing, job placement, or promotion decisions Health Services Administration STEM CELL RESEARCH Use of embryonic stem cells to create organs and various body tissues. highly controversial, involving religious beliefs and fears as to how far scientists might go in their attempt to create, e.g., another human being. Health Services Administration Healthcare Laws HEALTH SERVICES ADMINISTRATION Medical Device Reporting Safe Medical Devices Act of 1990 Requires reporting to the FDA and the product manufacturer of medical device occurrences that have or may have contributed to serious illness, serious injury, or death, including occurrences attributed to user error. Medical Device Amendments of 1992 clarified terms and established a single reporting standard for device users, manufacturers, importers, and distributors Health Services Administration Medical Device Reporting and HIPAA HIPAA allows medical device reporting without patient authorization To collect or report adverse events and product defects or problems To track FDA-regulated products To enable product recalls, repairs, replacements, or look back To conduct post-marketing surveillance Health Services Administration Medical Device Reporting Under the Freedom of Information Act (FOIA), FDA information may be accessed. FDA is required to delete the following: Any personal, medical, and similar information that would constitute a clear, unwarranted invasion of personal privacy Trade secrets and confidential commercial or financial information related to the manufacturer Identifying information of the reporter of the event Health Services Administration Reporting of Occurrences with Electronic Health Record Systems FDA has also been studying the issue of regulating EHRs ONC is working with FDA and representatives of patient, clinician, vendor, and healthcare organizations to determine role FDA should play to improve the safe use of certified EHR technology Health Services Administration The Stark Law The Stark Law AKA- ___________________________ Protects against fraud and abuse Prohibits physicians from referring to another provider with whom they have a financial relationship Investments Family members There are exceptions to this law Civil penalties for non-compliance up to $15,000 for each billed service that is based on a prohibited referral, plus three times the amount of the government overpayment Health Services Administration Anti-Kickback Statutes Prohibits the exchange of anything of value (remuneration) for referrals for services Services have to be paid for under a federal program Medicare Criminal Statute Providers can be faced with both criminal and civil penalties Criminal= penalties include fines of up to $25,000 and five years’ imprisonment. Civil= penalties of up to $50,000 per violation plus three times the amount of any government overpayment. Health Services Administration Patient Protection and Affordable Care Act Signed March 23, 2010 under the Obama Administration Goal= ________________________________ Required citizens to carry health insurance Established state and federal health insurance exchanges Health Services Administration PPACA- Essential Health Benefits All plans must include 10 categories of coverage 1. Ambulatory patient services 2. Emergency services 3. Hospitalization services 4. Pregnancy, maternity, and newborn care 5. Mental health and substance use disorder services, including behavioral health treatment (this includes counseling and psychotherapy) 6. Prescription drugs Health Services Administration PPACA- Essential Health Benefits All plans must include 10 categories of coverage 7. Rehabilitative services and devices (services and devices to help people with injuries, disabilities, or chronic conditions gain or recover mental and physical skills) 8. Laboratory services 9. Preventive and wellness services and chronic disease management 10.Pediatric services, including oral and vision care Health Services Administration Changes to PPACA 2014- citizens required to have health insurance or pay a fine via tax penalties (“individual mandate”) 2019- individual mandate repealed under Trump Administration (went into effect in 2020 tax year) 2021 and beyond- ???? Biden administration would likely re-enact individual mandate Health Services Administration CARES Act (2020) Coronavirus Aid, Relief, and Economic Security (CARES) Act Passed under Trump Administration on March 27th, 2020 Overwhelming bipartisan support $2 trillion economic relief package Money aimed at assisting those affected by the economic effects of the COVID-19 pandemic Health Services Administration CARES Act (2020) Four Types of Assistance: Assistance for American workers and families Economic impact payments (AKA: Stimulus checks) Assistance for small businesses Small business loans Job preservation Employee retention credits Payroll tax deferral Assistance for state, local, and tribal governments Public health expenditures related to COVID-19 Unexpected expenses not accounted for in the budget Health Services Administration Worker’s Compensation for Occupational Illnesses, Injury, Death Purpose of legislation Ensures employees injured on job or become ill as result of job are provided with some means of support while recovering from illness or injury Process Employee or employee representative files a worker’s compensation claim Must sign an authorization to release medical information to the workers’ compensation entity Information may be disclosed to other state or federal agency without patient authorization Health Services Administration Emerging Issues HEALTH SERVICES ADMINISTRATION MATCH IT Act Patient Matching and Transparency in Certified Health IT Act of 2024 Health Services Administration Artificial Intelligence in Healthcare Report on non-clinical AI in Healthcare Develop Educational Materials Educational Campaign Authorization of Funds Health Services Administration Questions??? Health Services Administration