Healthcare Law Final Exam
Sue Ann Lawrence
- https://www.nytimes.com/1991/07/28/us/despite-daughter-s-death-parents-pursue-right-to-die-case.html
Terri Schiavo
- https://www.wnd.com/2005/03/29516/
Conscience clause
- if a nurse or doctor does not believe in a procedure for a moral reason then he or she cannot get fired -protection from firing for moreal beliefs
Therapeutic Sterilization
- when pregnancy is a risk
Patient Self-Determination Act
-A federal law passed in 1990 that requires hospitals and other health care providers to provide written information to patients regarding their rights under state law to make medical decisions and execute advance directives. -can receive federal funding to summarize the facility's policies regarding advanced directives, advise patients of their right to make medical decisions and obtain and include in the medical record any such documents the patient might have executed
Elements of a Corporate Compliance Program
-Contain established compliance standards and procedures -Be overseen by high-level personnel -Provide that no discretionary authority in the organization may be vested in persons who are known (or should be known) to be likely to engage in criminal conduct -Effectively communicate its procedures and standards of conduct to employees and agents of the organization -Contain reasonable methods for achieving compliance with the standards of conduct -Provide for, and the organization must carry out, appropriate and consistent discipline -Periodically reassess and revise the program as necessary
Reasonable Patient Standard
-Could a reasonbly prudent patient understand the procedure and its implications
Investigative departments of the federal government
-FBI -Department of Justice -DHHS
Indiana Abortion Statutes
-First sentences- childbirth is preferred, encourages and supported over abortion -conscience clause in Indiana- a physician or any medical personnel can decide to not partake in an abortion if they do not agree in the morals of the abortion
Karen Ann Quinlan
-In 1975, after being out with friends, Karen Ann unexpectedly lapsed into a coma. Her friends found her and delivered CPR while waiting to get her to Newton Memorial Hospital. Upon arrival, doctors could find no specific reason for the coma, and started life support, which included the respirator. -https://www.karenannquinlanhospice.org/about/history/
Durable Power of Attorney
-In response to the difficult questions living wills did not address -DPOA allowed for individuals to designate a proxy who will make healthcare decisions for them if they become incompetent. -this persons decisions are as valid as if the actual patient made the decisions -physicians who rely in good faith on the decisions of the proxy are provided immunity from civil and criminal liability
Nancy Cruzan
-Nancy Cruzan was a 25-year-old southwest Missouri woman who was thrown from her car in 1983 when it flipped over. Three years after sustaining major injuries from this incident, Nancy was still in a rehabilitation hospital operated by the State of Missouri. Her physicians and family members concluded she would never return to full consciousness, and her family began a long legal battle to have her feeding tube removed so she could die. -After nearly eight years, the family won the case. Nancy's tube was removed and she died 12 days later on December 26, 1990. The Court's ruling affirmed that all adults with decision making capacity have the right to— • Choose or refuse any medical or surgical intervention, including artificial nutrition and hydration. • Make advance directives. • Name a surrogate to make decisions on their behalf -The Court also said that surrogates can decide on a certain course (e.g., treatment or not) even when all concerned are aware that such measures will hasten death, as long as causing death is not their intent. The Cruzan case was the first so-called "right to die" case to be reviewed by the United States Supreme Court.
Vicarious Liability
-Organization responsible for the acts of its agents -employees -independent contractors
Exceptions of stark laws
-Ownership and financial interests that are permitted -Physician within a group practice who refers patient for MRI, CT, or PET to be provided within the group practice MUST provide the patient at the time of referral with written notice that the patient may obtain these imaging services from a supplier other than the group practice; This alters the original exception which is what basically permits physician group practices to own and operate and receive compensation for imaging services and other DHS provided within their group practice -Exceptions applicable only to ownership or investment arrangements (ex. exceptions for publicly traded securities and mutual funds, services furnished by a rural provider, and ownership in a whole hospital) -Exceptions applicable only to compensation arrangements (ex. exceptions for bona fide employment relationships, personal services arrangements and rental of office space and equipment)
Stark Laws
-Physician Self-Referral: can NOT refer patients to an organization that physician has financial interest in -Critics of the practice allege an inherent conflict of interest, given the physician's position to benefit from the referral, and suggest that such arrangements may encourage over-utilization of services, in turn driving up health care costs -Critics believe that it would create a captive referral system, which limits competition by other providers
Two Standards of informed consent
-Professional Community Standard -Reasonable Patient Standard
Patient Self-Determination Act (PSDA)
-Requires states to prepare written descriptions of state laws regarding advanced directives and written instruction such as a living will or durable power of attorney for health care and relating the provision of care when the individual is incapitated. This information is to be given to the provider organization at the admission of the patient
What are the safe harbors of the Anti-Kickback law
-Safe Harbors: certain types of payments are exempt from the statute -E.g. discounts reflected in Medicare cost reports; amounts paid by an employer to an employee to provide healthcare services; waivers of coinsurance for public health service beneficiaries; and certain payments through risk-sharing arrangements
Roe v Wade
-Texas; said that it was a crime to have an abortion unless the abortion would save the life of the mother; prosecutor makes sure that no one goes against this -Jane Roe challenged this because she was unmarried and pregnant and she could not afford to drive to another jurisdiction to have the abortion -Her life was threatend by this pregnancy -the statuted involving abortion in Texas was vague and hard to understand -Viability- babies are now viable at 20 weeks unlike back in the 1920s due to medical advances -Parties included Roe Mr. and Mrs. doe and the state of Texas -Right to Privacy in this case- the court said there is not right to privacy state in the text of the constitution however the court finds this -Common law- according to Roe there was still an argument that this could be treated as murder; common law is old English law -Trimester test have to do with this case- in the first trimester the state does not have the interest to protect that unborn life- the life is not viable; the middle trimester is grey area on whether the state should protect the unborn child; no one really argues about the third trimester because a baby is viable during that time -Did the case and decision decide when life is? No it did not; this was the entire question of the case and what it was trying to determine
Health reform law expands False Claims Act
-The changes could expose physicians to additional liability while empowering whistle-blowers to play a greater role in rooting out fraud -Enhances prosecutors' fraud-fighting tools, often with the help of whistleblowers; Allows whistleblowers to initiate false claims actions based on information already publicly disclosed through state or local administrative reports or proceedings, such as a Medicaid audit (i.e. a whistleblower no longer has to be the original source of the information to be able to use those additional facts to help build a case) -Imposes an explicit duty on physicians to return known overpayments to the government within 60 days of discovering an error -Makes clear that anti-kickback violations also can give rise to false claims liability, creating a double risk for doctors -Because a wide range of activities could be considered kickbacks (from discounts to referral fees to marketing practices) doctors should scrutinize their arrangements with other health care entities
Who has the responsibility of obtaining consent and informing the patient?
-The physician has the dury to obtain consent -the hospital has the duty to make sure the physician has fulfilled that duty -hospitals failure to ensure consent can result in vicarious liability andcorporate negligence
Indiana Statute IC 16-36-3
-Therapeutic Privilege to Withhold -Older cases held that a physician may limit or withhold information from patient for sound therapeutic reasons -Privilege unlikely to stand today if the facts indicate that a competent and rational patient would have declined treatment had there been full disclosure
Penalties of Anti-Kickback Law
-Up to 5 years in prison, criminal fines up to $25,000, administrative civil money penalties up to $50,000, and exclusion from participation in federal health care programs -Law caused providers concern that some relatively innocuous (and in some cases even beneficial) commercial arrangements are prohibited by the anti-kickback law...;As a result, Congress authorized the Department to issue regulations designating specific "safe harbors" for various payment and business practices that, while potentially prohibited by the law, would not be prosecuted
Professional Community Standard
-What would be a reasonable consent within the area of practice of the physician who is treating the patient
Wrongful birth and wrongful life
-a baby has been born after a sterilzation procedure; this could potentially result in malpractice against the physician who performed the sterilization procedure -Courts in virtually all jurisdictions have held that physicians owe a duty of care to the parents and even to the unborn child
State Interests (Refusal to Consent)
-a court would not order treatment for patiens who exercise right to refusal unless a compelling state interest overrides the rights of the patient -State has four interests that may override individual freedom --preservation of life --protection of innocent third parties --preservation of the ethical integrity of medical profession --prevention of suicide
Oregon law regarding terminal illness
-a licensed physician may give a patient medications to end their life if they are within 6 months of death -a second physician must confirm the first physicians findings
General Consent Form
-a patient is asked to sign as part of the registration process to grant the hospital permissoin to provide routine care and nursing services. -this form details that various people will be closely involed in the patient's treatment -says that the hospital does not guarantee a cure -and tells of the care the patient is about to recieve
What conditions must be met to file a Qui tam suit?
-allegations not exposed publicly at an earlier date
Living wills and natural death acts
-allowing terminally ill patients to die with dignity -vary state to state
National POLST paradigm
-began in Oregon -set of medical orders, similar to a DNR order. -not an advanced directive -together with a physician, the patient comes to a conclusion about desired treatment best on the persons values beliefs and goals for care
Right to Refuse
-competent patient's express refusal to consent must be honored, even if death is result -physician's duty to render care ends when patient refuses consent
Elective Sterilization
-consent is very important -has a heightened importance because it involves the inability to bear children after the proceudre; so we sat wait a minute you better know what you are agreeing to
Corporate Negligence
-corporation responsible for the well-being of patients
What is the purpose of the Antikickback statute?
-criminal statute that prohibits transactions intended to induce or reward referrals for items or services reimbursed by the federal health care programs. -can not accept payments for referrals
Abortion as a criminal act in Indiana
-criminal unless performed in the first trimester; the woman consented; physician thinks woman is at risk to continue with pregnancy -if woman is in third trimester the physician has to provide in writing that the woman needs this to save her life -18 hours before the abortion the physician has to inform the patient with the given information in this statute
Minors and Contraception
-debate in class about how much control should the government have on this class? -Question whould minors by law be able to prescribe contraception without parent or guardian approval? -yes, not to spreat babies, STDs. -no same as consent before surgery
Stark self referral law
-discourage overuse of healthcare services -remove conflict of interest from physician decision making -all in all this law prohibits physicians from referring Medicare patients for designate health services to entities which the physician or immediate family member has a financial relationship
Expressed Consent
-does not need to be given in writing -spoken consent is adequate -written consent may be given as well
What is considered a claim?
-each billing form is one claim; not each individual code
Reasons for corporate compliance
-early detection -management liability -government enforcement
History "Lincoln Law"
-false claims -establishes liability when any person or entity improperly recieves from or avoid payments from the federal governement -Act prohibits: Knowingly presenting, or causing to be presented a false claim for payment or approval; Knowingly presenting, or causing to be presented a false claim for payment or approval -No proof of specific intent to defraud is required-Person must either (1) have actual knowledge that the information is false, (2) act to deliberate ignorance of the truth or falsity of the information, or (3) act with reckless disregard of whether it is true or false; This standard requires healthcare providers to have mechanisms in place to verify the accuracy of their organization's claims -Penalties-Treble damages and civil fines of $5,500 to $11,000 per false claim; Each billing form is one claim; Defendant payment of the successful plaintiff's expenses and attorney's fees; Rewards for qui tam plaintiffs between 15-30% of the funds recovered from the defendant; Can be a criminal offense that imposes a $500,000 fine upon an organization and$250,000 fine on an individual and up to 5 years in jail; Government must prove its case beyond a reasonable doubt that the defendant knew the claim was false (fewer criminal cases are being brought)
Examples of Fraud and Abuse
-filing false claims for services not rendered of not medically necessary -misrepresenting the time, location, frequency, duration or provider of services -up coding- assigning a higher payment than the procedure or diagnosis warrants -unbundling- billing a battery of services separately
Rape Statutes
-genereally, you do not need consent to examine a rape victim
Federally Funded Sterilization
-have to be 21 years old to have federall money used for your procedure
BAC test
-if you operate a care on an Indiana road, you impliedly consent to a BAC test if officer has probable cause to believe you have been driving under the influence
Living wills
-instructs their physician to withhold or withdraw certain life sustaining procedures during the event of terminal illness -California set the example for living wills so that states could base their own statutes, but soon lawmakers were bombarded with difficult situations that living wills did not address
Consent of Spouse or other relative
-marriage or blood relationship alone does not entitle someone to consent to treatment on their behalf -If patient is not competent to consent and has not appointed an agent, state law usually provides a hierarchy of individuals who may make decisions for the patient, which often include spuse, adult child, parent, or adult sibling
What 5 things must be given during informed consent
-must be given diagnosis and prognosis -you must be told nature and purpose of proposed treatment -consequences must be known -probability of success -alternatives
Informed Consent
-must be informed- only a physician can properly communicate information and answer patient's question
Consent in Medical Emergencies
-no consent is required in a medical emergency -the law presumes that consent would be given -rule applies to all patients, regardless of age, and is sometimes called implied consent
What constitutes as a medical emergency?
-not always easy to define -provider must show that the urgency of the situation made giving consent in a timely matter -a conscious, competent adult is entitled to refuse lifesaving care; therefore, treatment without consent is only permitted only if patients or those authorized to act for them are unable- as a result of an emergency situation. -emergency means a situation that presents an immediate danger of death or permanent impairment of health -a mere desire to treat quickly is not the same as an emergency
Right to Privacy in the constitution
-not specifically stated in the constitution but it is implied
Who investigates cases under the False Claim Act?
-office of inspector general and brought by a US attorney or department of justice -the statute does have an unusual feature in that it allows private citizens to sue on their own behalf, oh behalf of the government to reconvene damages and penalties.
Special Consent Form
-patient is asked to sign whenever surgery or special diagnostic procedures are indicated -this is to be signed by the patient after the physician clearly explained all the necessary information and has answered all the patient's answers -the language of this documet must be in words the patient can understand -only physicians may administer this type of consent since the patient must fully understand the language
Consent obtained under misrepresentation
-people under anesthesia cannot give consentm (they have to be able to understand the consequences and understand what is in the forms)
What sections are on the special consent form?
-physician name -point out what other individuals will be involved in the patient's care -procedures that are going to be done -state that unforseen conditions may arise or different procedures may be necessary
Who has responsibility of obtaining consent and informing patient?
-physician's duty is to obtain consent; the hospital's duty to determine whether the physician has fulfilled that responsibility -Hospital discharges its duty properly by making physicians aware of their responsibility to inform patients, by making tools such as standard consent forms available, and by insisting that adequate written documentation of patients' consent by placed in medical record
What is a referral?
-physicians referring a patient to a another physician
Did DPOA resolve all issues of the living will?
-resolved some but not all -people still need to take affirmative action -varied state to state
Griswold V.Connecticut
-set precedent for contraception debates Roe v. Wade -griswold was a director of a planned parenthood program and was arrested for giving contraception advice to couples -Connecticut had a statute that said it was a criminal act to take contraception -married couple in connecticut did not want children because it would cause complications to the woman -challenged the statute about birth control -the constitution says that Connecticut cannot enforce this statute -this case made the Supreme Court say that there is a right to provacy in the constitution
General Consent
-signed by patient as part of registration; grants hospital right to perform routine care; documents that various people will be closely involved in treatment
Types of written consent
-specific consent -general consent
Third Party liability for contraceptives
-story told in class about how he moved into an old physician's house and all the old medical files were kept there. Soon women were calling asking for files because they had cancer and the doctors they were seeing were saying that the birth control could be responsible -birth control manufacturers had third party liability
Purpose of Medicare/Medicaid Anti-Kickback Law of 1972
-to protect patients and the federal health care programs from fraud and abuse by curtailing the corrupting influence of money on health care decisions -to protect patients and the federal health care programs from fraud and abuse by curtailing the corrupting influence of money on health care decisions; -Willfulness:" must show that the defendant ▪ (1) consciously committed an illegal act (offered/paid/solicited/received remuneration), ▪ (2) had a nefarious purpose in mind (medical referrals or purchases)
Buck v Bell
-woman is to be sterilized and suffers from a mental disability -mother and grandmother suffer from this disability -comes time to sterilize the daughter but consent becomes questionable due to mental illness -went to supreme court
Qui Tam
A lawsuit brought by a private citizen against a person Or company who is believed to have violated the law in the performance of a contract with the government or in violation of a government regulation, when there is a statute which provides for a penalty for such violations -the plantif will be entitled to a percentage of the recovery penalty as a reward for exposing the wrongdoing and recovering funds for the government -PLANTIFFS OFTEN CALLED WHISTLEBLOWERS OR RELATOR
Procedures Differing from Patient's Authorization
Traditional Rule- unless a true emergency exists, the original surgery should be completed and new condition addressed at a later time
What are some special consent circumstances in which spousal consent may be required
artifical insemination involving a third-party donor -surrogacy
Should spousal consent be mandatory for elective sterilization?
no- because it is not the governments business; if you and your spouse do not have the type of relationship where you can discuss this topic then this ia a fundamental issue in your relationship; domestic abuse people should not need consent yes- it involved both parties and the inability to not bear children
Specific consent
obtained whenever surgery or special diagnostic procedures are indicated (should be signed only after physician has clearly explained all neccessary information)
Antikickback law
so if provider A offers provider B cheap rent for space in their office... and in return for the cheaper rent, provider B promises to refer a certain number of patients to provider A... this is an anti-kickback because they are receiving the remuneration for referring people someone for services for which payment is made from a federal healthcare plan (so they would be getting reimbursed for those visits from medicare)
Stark law
stark prohibits physicians from referring medicare patients to any place where the physician or one of the physician's immediate family members has a financial relationship and could have a personal gain