for DR.SAMUELSON only!!!!
Essentials of Health Care Compliance
Week Three
Compliance: Patient Consent
Learning Outcomes
Identify the various situations in which consent is required
Determine the components of each type of written consent form
Explain the types of advance directives
Establish internal policies for acquiring patient consent
Design a process to handle release of information
The single biggest problem with communication is the illusion it has taken place.
George Bernard Shaw
Informed Consent
Educational Process
Not just a signed form
Why
Patient’s Freedom of Choice
Educate patient
Honesty
Build doctor-patient rapport
Protection from liability
Patients will accept some responsibility
Patients won’t sue if they like and trust the doctor
Absolute liability based on battery
Any downside?
Why do doctors fail to get informed consent?
Patient Consent: Patient Self-Determination Act
(applies to hospitals, skilled nursing facilities, home health agencies, and hospice programs)
maintain written policies and procedures with respect to all adult individuals receiving medical care by or through the provider or organization--
(A) to provide written information to each such individual concerning--
(i) an individual's rights under State law (whether statutory or as recognized by the courts of the State) to make decisions concerning such medical care, including the right to accept or refuse medical or surgical treatment and the right to formulate advance directives (as defined in paragraph (3)), and
(ii) the written policies of the provider or organization respecting the implementation of such rights;
(B) to document in a prominent part of the individual's current medical record whether or not the individual has executed an advance directive;
(C) not to condition the provision of care or otherwise discriminate against an individual based on whether or not the individual has executed an advance directive;
(D) to ensure compliance with requirements of State law (whether statutory or as recognized by the courts of the State) respecting advance directives at facilities of the provider or organization; and
(E) to provide (individually or with others) for education for staff and the community on issues concerning advance directives.
Subparagraph (C) shall not be construed as requiring the provision of care which conflicts with an advance directive.
Patient Consent: Patient Self-Determination Act
The written information described in paragraph (1)(A) shall be provided to an adult individual--
(A) in the case of a hospital, at the time of the individual's admission as an inpatient,
(B) in the case of a skilled nursing facility, at the time of the individual's admission as a resident,
(C) in the case of a home health agency, in advance of the individual coming under the care of the agency,
(D) in the case of a hospice program, at the time of initial receipt of hospice care by the individual from the program, and
(E) in the case of an eligible organization (as defined in section 1395mm(b) of this title) or an organization provided payments under section 1395l(a)(1)(A) of this title or a Medicare+Choice organization, at the time of enrollment of the individual with the organization.
The term “advance directive” means a written instruction, such as a living will or durable power of attorney for health care, recognized under State law (whether statutory or as recognized by the courts of the State) and relating to the provision of such care when the individual is incapacitated.
42 U.S.C.A. § 1395cc (West)
US Constitution: 14th Amendment
No State shall . . . 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.
Cruzan by Cruzan v. Dir., Missouri Dept. of Health, 497 U.S. 261 (1990)
Patient in persistent vegetative state.
Suit to terminate artificial hydration and nutrition for patient.
No advance directive – only comments to roommate
Missouri required “clear and convincing” evidence
Guardians failed to meet that standard.
“A competent person has a constitutionally protected liberty interest in refusing unwanted medical treatment.”
Consent to Treat
Implied consent – the patient did not specifically write down an agreement to be treated by a health care professional; however, their actions indirectly indicated this agreement.
What if patient didn’t understand risks?
What if patient “forgets”?
What if patient dies and family disputes consent?
Express consent -- more formal process of consent that usually includes a signed, written consent form
Components of informed consent
The patient’s diagnosis or reason underlying the recommendation for this procedure or protocol.
A description of the procedure or therapy protocol.
The expected benefits.
The potential risks of having the procedure or therapy, including side effects
The potential risks of not having the procedure or therapy.
Alternative treatments.
Length of time for recovery (estimated).
Necessary aftercare.
Patient costs.
Risk of CVA
“Aaron Felton sought treatment for neck pain from [DC]. [DC] obtained a history, x-rayed Felton's cervical spine, and on two occasions, manipulated his neck. When the treatments did not provide relief, [DC] performed a more forceful manipulation on Felton's third visit.”
“Felton immediately began experiencing blurred vision, nausea, and dizziness. [DC] called an ambulance, which took Felton to the hospital, where doctors determined that he had suffered a stroke resulting from a vertebral artery dissection.”
Risk of CVA
“A reasonable health care provider must disclose the risks that would influence a reasonable patient in deciding whether to undergo treatment but not those that would be unduly disturbing to an unreasonable patient.”
“[T]he possibility of vertebral artery dissection and stroke is precisely the kind of information a reasonable patient would be expected to want to know before deciding whether to risk such severe consequences in order to alleviate neck pain.”
388 S.W.3d 656 (Tex. 2012)
Advance Directives
Living Will – Directive to Physicians
Revocable
Do not resuscitate (DNR) order
Surrogates – Health Care Power of Attorney
Advance Beneficiary Notice
mandated for consent to treat a Medi- care beneficiary whose procedure or service is known, or expected, to be denied Medicare coverage, resulting in the patient having to pay all charges, or a portion of the charges beyond their co-payment and co-insurance.
Use official CMS form
Protected Health Information / HIPAA
Notice of Privacy Practices
Written acknowledgement by patient
Release of Information – Written Authorization
Identify Patient
To whom the PHI is permitted to be disclosed
From – who will be releasing PHI
What information is to be disclosed
Expiration date or event
Right to revoke
Consent to contact – method of communication
Protected Health Information / HIPAA
Superconfidential Information
HIV/AIDS
Pregnant Minors
Sexually transmitted diseases
Alcohol and drug addiction
Mental health conditions
Documentation
Model Notices of Privacy Practices
Authorization to Disclose Protected Health Information
https://www.texasattorneygeneral.gov/files/agency/hb300_auth_form.pdf
Week 4 Activities
View the Lecture Materials for the week.
Read the Assigned Readings – Chapters 3 and 4
Complete the Week 4 Case Study by Sunday at 11:59 p.m. Central time zone.
Post a response to the Discussion prompt for the week by Wednesday at 11:59 p.m. and respond to two or more of your peers by Friday at 11:59 p.m.
Complete and submit the Week 4 Chapter Review Quiz by Sunday at 11:59 p.m. (covers chapters 3 and 4)