by Elizabeth Hogue, esq.
New Conditions of Participation (CoPs) of the Medicare Program for home health require agencies to take action to protect patients' exercise of their rights. The Centers for Medicare and Medicaid Services (CMS) issued draft Interpretive Guidelines for the new CoPs for home health agencies on October 27, 2017. The draft provides information about what surveyors will be looking for when they survey agencies based on the new CoPs for patients' rights.
With regard to patients' rights, Section 484.50(c(4) of the draft interpretive guidelines makes it clear that patients have the right to participate in, be informed about and consent to or refuse care in advance of and during treatment, as appropriate, with regard to:
What must Agency staff members do to obtain informed consent from patients? First, it is important for agencies to understand some of the basics regarding informed consent. In order to obtain valid informed consent, providers must first establish that two prerequisites have been met: capacity, and voluntariness.
Capacity is defined in terms of chronological age and in terms of the ability to understand information. Patients must have attained the age of adulthood before they are generally able to give valid informed consent. The age of adulthood or majority varies from state to state, since it is established by each state legislature through statutes. Many states have determined that patients are adults at 18 years of age. Capacity is also defined in terms of patients' ability to understand information. This ability is necessary in order to ensure that patients understand the treatment choices available to them.
It is often difficult for providers to determine if patients can understand the information given to them. This difficulty stems in part from the fact that mental capacity may vary from day to day, perhaps even from moment to moment. Staff member evaluations of mental capacity may, therefore, differ tremendously. This difficulty can be partly alleviated through the regular use of so-called mini-mental state examinations. Examples of these brief tests of mental capacity may be found in nursing and medical textbooks on psychiatry.
Staff must also determine that patients' consent to treatment is voluntary. Specifically, staff must evaluate whether there is any fraud or duress that interferes with patients' ability to make independent decisions.
When the above two prerequisites are met, staff may then proceed to provide information necessary to patients in order to provide valid informed consent. Patients must first receive a detailed description of proposed treatment. Thus, general consent forms indicating that patients have agreed to any and all treatments rendered are invalid.
This requirement also means that informed consent must be obtained whenever patients' treatments change. Informed consent is not something that is obtained upon admission and then never addressed again. When patients' treatments change, informed consent must be obtained again using a specific description of the new treatment(s). This requirement is included in the draft Interpretive Guidelines:
Providers must tell patients about significant risks associated with particular treatments. Practitioners obviously cannot disclose all of the risks associated with specific treatments. Instead, they must tell patients about those risks that they know are statistically significant or are particularly important to individual patients. If, for example, there is a fifty percent chance that a patient will die while undergoing proposed treatments, this risk must be disclosed. Another example is the case of a patient who is a world-famous violinist. Although proposed treatments have a statistically small probability of adverse effects upon the violinist's hands, this risk must be disclosed, nonetheless, since staff members are aware that this it is particularly important to the patient.
Possible benefits of treatment must also be explained to patients as a part of the routine process of obtaining informed consent. The emphasis must be on the word "possible." Practitioners have to be careful not to guarantee any particular result to patients. If certain outcomes are promised, some courts have ruled that a contract has been established between patients and providers that practitioners breach when they fail to produce promised results.
In addition, alternative treatments should be explored with patients. According to the draft Interpretive Guidelines, patients should, for example, be able to choose between a bath and a shower, unless there are physical restrictions or medical contraindications.
Finally, patients' absolute right to refuse treatment must be directly affirmed to patients as a part of the consent process. As Judge Kelleher pointed out in Wilkinson v. Vessy, 295 A. 2d 676, 690 (R.I., October 20, 1972), obtaining valid consent is "good medicine, good humanity, good public relations, and good medico-legal defense."
(To obtain a copy of Informed Consent, which includes more information about how to obtain valid informed consent from patients, send a check for $25.00 that includes shipping and handling made out to Elizabeth E. Hogue, Esq. to: Fulfillment, 107 Guilford, Summerville, SC 29483.)
©2017 Elizabeth E. Hogue, Esq. All rights reserved. No portion of this material may be reproduced in any form without the advance written permission of the author.
©2017 by Rowan Consulting Associates, Inc., Colorado Springs, CO. All rights reserved. This article originally appeared in Tim Rowan's Home Care Technology Report. homecaretechreport.com One copy may be printed for personal use; further reproduction by permission only. firstname.lastname@example.org