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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

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)