Advance Directives: Information on Federal Oversight, Provider Implementation, and Prevalence
Released: 2015-04-29T00:00:00

Letter

Background

PSDA, Advance Directives, and Advance Care Planning

As amended, the PSDA requires Medicare and Medicaid funded hospitals, nursing homes, hospices, HHAs, and managed care plans— including MA and Medicaid health maintenance organizations—to maintain written policies and procedures related to advance directives. Among other things, the policies and procedures maintained by covered providers are required to specify that the provider will: (1) provide written information to all adult individuals receiving medical care by or through the provider on their rights under state law to make decisions concerning medical care, including the right to execute an advance directive; and (2) document in the medical record whether the individual has an advance directive.

The PSDA defines an advance directive as 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. For example, an advance directive may be used to record an individual’s wish to receive all available medical treatment, to withdraw or withhold certain life sustaining procedures, or to identify an agent to make medical decisions on the individual’s behalf if necessary. The most common forms of advance directives are living wills and health care powers of attorney.

During the last 6 months of life, many individuals receive care from one or more covered providers, including hospitals and nursing homes, and having an advance directive that specifies an individual’s treatment preferences to covered providers in preparation for difficult medical decisions that may arise at the end of life may be useful. According to the IOM, advance directives are most effective when used as part of advance care planning, which may involve multiple, in-depth discussions with family members, legal and financial counsel, and healthcare providers, and may also include the formulation of medical orders. The IOM also reported that multiple discussions at various stages of life are needed, with greater specificity as an individual’s health deteriorates, because an individual’s medical conditions and treatment preferences may change over time. Therefore, a comprehensive approach to end-of-life care, rather than any one document, such as an advance directive, helps to ensure that medical treatment given at the end of life is consistent with an individual’s preferences.

Covered Providers and CMS Oversight

The six provider types covered by the PSDA provide or arrange for Medicare or Medicaid health care services in multiple settings for individuals of varying demographics. For example, nursing homes generally provide care in an institutional setting to older individuals who have chronic conditions, such as congestive heart failure, while hospices generally deliver palliative care in an institutional, home, or home-like setting to critically ill individuals of various ages who are close to the end of life. The characteristics and distribution of individuals enrolled in MA and Medicaid managed care also have similarities and differences. For example, individuals enrolled in MA may be disabled or elderly (over the age of 65), and individuals enrolled in Medicaid managed care may include adults who are also disabled and elderly. However, in 2013, CMS reported that half of the Medicaid population was children in comparison to Medicare in which 83 percent of beneficiaries were over age 65. In addition, while most individuals enrolled in Medicare are not enrolled in a managed care plan, over 70 percent of individuals enrolled in Medicaid are enrolled in some form of Medicaid managed care, according to CMS. However, the distribution of individuals enrolled in Medicaid across various demographic groups—disabled, elderly, adults, and children— varies widely by state.

In order to participate in the Medicare or Medicaid programs, covered providers must comply with applicable federal standards, including PSDA requirements. CMS is responsible for oversight of providers’ compliance with PSDA requirements and does so through both state survey agencies and accrediting organizations.

CMS enters into agreements with state survey agencies to conduct oversight activities of covered providers. Specifically, four of the six covered provider types—hospitals, nursing homes, HHAs, and hospices—must demonstrate their compliance with federal standards to a state survey agency. These agencies conduct surveys of covered providers—observations, interviews, and document/record reviews—that assess compliance with applicable requirements for Medicare and/or Medicaid participation. The survey process covers multiple standards. For example, there are about 200 quality and safety standards for nursing homes that range from determining the prevalence of pressure sores and use of restraints to documenting the posting of an individual’s bill of rights.

However, in some cases, particularly for hospitals, accrediting organizations provide primary oversight. Specifically, hospitals, HHAs, and hospices that choose to undergo accreditation by an accrediting organization, rather than certification from a state agency, must demonstrate to the accrediting organization their ability to meet the standards of accreditation, including PSDA standards. The accreditation organization subsequently recommends to CMS certification of providers meeting such standards. The processes that accrediting organizations use to certify providers for Medicare participation are subject to CMS review and approval. In addition, under agreements with CMS, state survey agencies annually survey a sample of accredited providers to verify the results of surveys conducted by the accrediting organizations, and assess the organizations’ ability to monitor providers’ compliance with federal standards.

The two remaining covered provider types—MA and Medicaid managed care plans—must contract with CMS or individual states to participate in the Medicare or Medicaid programs. Specifically, under MA, CMS contracts with private health plans to provide covered services to individuals who enroll in an MA plan, while under Medicaid managed care, individual states contract with private health plans to cover medical services; however, both MA and Medicaid managed care plans are prospectively paid a per person, or capitated, payment.

CMS Oversees Covered Providers’ Implementation of the Advance Directive Requirement by Providing Guidance and Monitoring Implementation

CMS Provides Guidance to Help Covered Providers Implement the Advance Directive Requirement to Maintain Written Policies and Procedures

CMS develops and disseminates guidance through operations manuals, memoranda, or model documents to five of the six covered provider types—hospitals, nursing homes, HHAs, hospices, and MA plans—to inform these providers of the requirement to maintain written policies and procedures about advance directives and to describe how the agency will monitor providers’ implementation. For example, CMS issues operations manuals specific to five provider types that describe the advance directive requirement and how each of these providers is required, in accordance with federal regulations, to maintain and provide each patient with written notice of the provider’s policies related to advance directives. These operations manuals also describe how the providers are required to maintain policies related to documentation of an individual’s advance directive in the individual’s medical record. CMS shares oversight of Medicaid managed care plans, the sixth covered provider type, with individual states. CMS is responsible for approving managed care contracts to ensure that they conform to advance directive requirements in federal regulation, and states are responsible for administering these contracts, including providing guidance to plans and ensuring that plans comply with contractual requirements, according to CMS officials. As a result, CMS does not issue guidance to Medicaid managed care plans.

CMS also provides an operations manual to four covered provider types—hospitals, nursing homes, HHAs, and hospices—to help these providers understand the standards state survey agencies will use during surveys to monitor the providers’ implementation of the advance directive requirement. Covered provider types may use this information to ensure that survey standards are met. In addition, CMS’s guidance informs the standards that accrediting organizations use during surveys to monitor accredited providers’ implementation of the advance directive requirement, because these standards must be approved by CMS as meeting or exceeding the Medicare standards. Guidance in the operations manual describes to state survey agencies and covered providers the activities and documents that may be observed and reviewed during surveys. For example, the operations manual indicates that state survey agencies may review the provider’s policies, examine an individual’s medical records for documentation that required information was provided to the individual, and whether or not the individual has an advance directive; or conduct interviews with other individual patients and provider staff to understand how the provider’s policies are implemented. One stakeholder we spoke with that represented HHAs reported that the survey process described in the operations manual demonstrates the importance that CMS places on advance directives.

Additionally, CMS issues memoranda available to state survey agencies and four of the six covered provider types—hospitals, nursing homes, HHAs, and hospices—that contain clarifications and new or revised guidance related to the advance directive requirement. For example, in September 2012, a CMS memorandum notified state survey agencies that CMS had updated its guidance regarding how survey agencies should assess nursing home compliance with the advance directive requirement and encouraged survey agencies to share the information with providers. Further, in October 2013, a CMS memorandum to state survey agencies clarified nursing homes’ cardiopulmonary resuscitation (CPR) policies in the context of an individual’s advance directive. According to the memorandum, nursing homes must provide CPR to all individuals in their care unless an individual’s advance directive specifies otherwise, and may not establish or implement facility-wide “no CPR” policies. The memorandum instructs state survey agencies to examine nursing home policies and individuals’ medical records to ensure that no such policy has been established or implemented. A stakeholder that represented nursing home providers reported that the memoranda and updated survey guidance for nursing home providers clarified and reinforced CMS’s expectations for nursing homes’ policies related to advance directives, and demonstrated CMS’s focus on providing oversight in this area.

In addition to the guidance that CMS provides to MA plans—the fifth provider type—through the Medicare Managed Care Manual (chapter 4 entitled, “Benefits and Beneficiary Protections”), CMS also provides MA plans with model documents used to inform enrollees about advance directives to demonstrate how plans are to implement the guidance in the manual. For example, the model document contains the exact wording that the plans must use to inform individuals enrolled in MA plans about their right to formulate an advance directive. MA plans are required to provide this document, called an Evidence of Coverage, to each individual at initial enrollment and each year thereafter. According to CMS officials, MA plans are not permitted to modify the language in the model document unless otherwise instructed by CMS. Officials also reported that CMS annually reviews the policies and procedures in the model document and, when necessary, updates them to ensure that they reflect current laws and CMS policies. CMS relies on states to provide guidance to Medicaid managed care plans—the sixth provider type—because states are responsible for administering contracts with these plans.

CMS Monitors Covered Providers’ Implementation of the Advance Directive Requirement

CMS’s activities to monitor covered providers’ implementation of the advance directive requirement vary across the six covered provider types and include periodic surveys, contract reviews, and the collection of certain related data. CMS enters into agreements with state survey agencies to conduct most surveys. Specifically, under agreements with CMS, state survey agencies periodically survey four of the six provider types—hospitals, nursing homes, HHAs, and hospices. Survey frequencies for each provider type are determined by statute or CMS policy. For example, the frequency of nursing homes, HHAs, and beginning in 2015, hospice standard surveys is statutorily determined and must occur, on average, every year for nursing homes and every 3 years for HHAs and hospices. The frequency of hospital standard surveys is determined by CMS and should occur, on average, every 3 years. According to CMS officials, state survey agencies follow up with providers to correct deficiencies found during surveys, and may work with CMS to impose enforcement actions, such as civil monetary penalties and termination, on providers that do not correct deficiencies in a timely manner.

Through state survey agencies, CMS retains data regarding deficiencies related to advance directives identified during surveys of hospitals, nursing homes, HHAs, and hospices. The data—which, according to CMS officials, the agency uses for enforcement actions—indicate that the rate of noncompliance with the advance directive requirement among these four covered provider types in 2012 and 2013 was less than 3 percent for the providers surveyed in each given year. For example, about 2 percent of the 14,161 nursing homes that were surveyed in 2013 had a deficiency related to the advance directive requirement. Deficiencies related to the advance directive that were identified during surveys of the four provider types included providers’ failure to inform individuals about advance directives, including failure to provide individual patients with written information about the providers’ policies regarding advance directives. Providers also failed to accurately document an individual’s advance directive in the medical record. Surveyors based their findings on observations, medical record reviews, and interviews with provider staff, and noted that a provider’s failure to ensure that individuals have an opportunity to formulate complete and accurate directives has the potential to cause harm to individuals who may receive treatment or have treatment withheld when their exact treatment preferences are not known. In addition, accrediting organizations— through findings from periodic surveys of providers that would include findings related to providers’ compliance with the advance directive requirement—may recommend to CMS whether accredited providers should maintain their certification.

In addition to the survey process for hospitals, nursing homes, HHAs, and hospices, CMS reviews contracts from the two remaining covered provider types—MA plans and Medicaid managed care plans. Specifically, CMS reviews MA and Medicaid managed care plan contract provisions addressing compliance with applicable requirements, including the advance directive requirement. According to CMS officials, each MA plan must annually renew its contract with CMS indicating that it will comply with Medicare laws and regulations, which includes the advance directive requirement. Although the MA plan’s contract application indicates that CMS may conduct monitoring activities, such as on-site visits to the plan’s facilities to verify the plan’s compliance with Medicare requirements, CMS does not currently conduct such activities related to the advance directive requirement. CMS officials told us that current audits of MA plans are focused on outcome based measures, such as plans’ coverage determinations, which would not indicate noncompliance with the advance directive requirement.

For Medicaid managed care plans, CMS officials reported that CMS staff review contracts between the plan and individual states prior to implementation of a new plan contract or when revisions are made to an existing approved contract to ensure that the contract addresses provisions related to advance directives. CMS staff use a contract review checklist that includes the regulatory language related to the advance directive requirement when conducting their review. For example, staff are to indicate on the review checklist whether the contract under review requires that the plan maintain written policies and procedures on advance directives for all adult individuals receiving medical care by or through the plan. However, CMS does not currently have data on the extent to which Medicaid managed care plans’ contracts address the advance directive requirement. Although CMS recently began electronically collecting contract review data, the data will indicate the extent to which plans’ contracts address advance directive requirements, but not the extent to which plans’ implementation is in compliance with the contractual provisions. CMS does not conduct audits of Medicaid managed care plans to monitor implementation or identify noncompliance with contractual provisions. CMS officials reported that this is because individual states are legally responsible for monitoring the Medicaid managed care plans with which they contract.

Approaches Used to Inform Individuals about Advance Directives Vary by Provider Type, but Providers Face Similar Challenges

Providers use various approaches to inform individuals about their right to have an advance directive, either as part of the admission or the enrollment process depending on the type of covered provider, according to CMS and stakeholder officials, and the limited amount of information found in the literature about certain types of providers. For example, four of the provider types—hospitals, nursing homes, HHAs, and hospices— provide individuals with information about their right to formulate an advance directive during the admission process, according to interviews with stakeholder officials representing these provider types and 10 studies. In contrast, MA plans and Medicaid managed care plans provide written information to individuals on their right to formulate an advance directive during the enrollment process, according to stakeholders we interviewed. MA plans provide individuals enrolling in the plan with a model document developed by CMS—the Evidence of Coverage—to inform individuals about their right to have an advance directive, according to CMS officials. Medicaid managed care plans also provide written information at the time of enrollment, according to a stakeholder official that represented a Medicaid managed care plan.

Providers’ approaches also vary in the extent to which they each discuss information about advance directives with individuals, according to the literature and stakeholder officials. Specifically, hospital staff do not generally discuss advance directives with individuals during the admission process, as five stakeholders, including officials representing three provider types and individuals close to the end of life, and six studies noted. By contrast, staff for three other covered provider types— nursing homes, HHAs, and hospices—nurses, social workers, or case managers generally discuss advance directives during the admissions process as part of one or more advance care planning discussions with individual patients, according to the findings from four studies and five stakeholders. However, information on the extent to which MA and Medicaid managed care plan providers discuss advance directives with individuals enrolled in the plans is more limited. Specifically, we did not identify any peer reviewed studies in our literature review that addressed MA and Medicaid managed care plans. In addition, although a stakeholder representing both an MA plan and Medicaid managed care plan told us that while the stakeholder’s plans require their providers to discuss advance directives with individual enrollees during an initial health assessment and during annual visits with their physicians, not all plans take a similar approach.

Covered providers generally document whether an individual has an advance directive either in paper medical records or in an electronic health record, according to the limited information in the literature and the stakeholder officials we interviewed. Specifically, each stakeholder official we spoke with and six studies we reviewed found that all six covered provider types document individuals’ advance directives using either paper medical records or electronic health records, and some of these sources indicated that providers may also keep a copy of individuals’ directives in these records if such documents are available.

Providers face similar challenges in informing individuals about advance directives and documenting them, according to the literature and stakeholder officials. The challenges to informing individuals about advance directives include discomfort talking about end-of-life issues, confusion about which staff should have the discussions with individuals, and lack of staff time to have the discussions. Specifically, 18 studies found and five stakeholder officials representing providers and seniors confirmed that providers, individual patients, or both are often uncomfortable talking about end-of-life issues, in some cases even when an individual is close to the end of life. For example, 9 studies found that physicians often do not communicate poor prognoses with individuals, in part, due to their discomfort to do so, which can deprive individuals of the opportunity to understand that they are nearing the end of life and the opportunity to discuss their advance care preferences in that context. Three studies also found confusion about which staff—nurses, social workers, or physicians—should have discussions to inform individuals about advance directives, although most individuals prefer to have these discussions with their physicians, according to 3 other studies. In addition, 10 studies found that physicians may either not have the time or do not spend the time discussing end-of-life issues with individual patients. Two stakeholders that represented managed care plans and seniors also noted the time constraints physicians face when discussing advance directives with individual patients.

Other challenges that providers face informing individuals about advance directives are associated with individuals’ lack of understanding about advance directives and challenges informing certain demographic groups about them, according to the literature. Specifically, 13 studies found that many individuals lack an understanding about advance directives, assume incorrectly that these documents are expensive or require attorneys, or have difficulty understanding complex medical information included in some advance directive forms. Thirteen studies also identified challenges specific to Latinos or African Americans, such as language barriers, lack of trust in health care providers, or fear that advance directives may prevent them from getting the care they want to receive.

In addition to the challenges with informing individuals about advance directives, providers face similar challenges documenting this information, such as errors in individuals’ medical records and challenges related to access or updates to advance directives, according to the literature and stakeholder officials. Specifically, nine studies found errors in individuals’ records related to advance directives, such as lack of documentation about advance directives that should have been included in the records— in one case despite the fact that individuals had recently discussed directives with providers. In addition, five studies reported challenges related to access to this information, such as challenges identifying where a copy of individuals’ directives may be located or concerns that information about directives may not be transferred with individuals if they are moved from one provider to another; for example, from a nursing home to a hospital. Similar concerns about access to documents were reiterated by four stakeholders we interviewed that represented providers and seniors. Two stakeholders representing nursing homes and managed care plans reported that providers face difficulties ascertaining in the documentation whether individuals had recently reviewed or updated their directives, or if the directives in individuals’ records were current.

Providers may better address challenges to inform individuals about advance directives and document them by using leading practices, according to the literature and stakeholders. Some of the leading practices for informing individuals about advance directives include patient education, materials tailored for specific groups, or an iterative advance care planning process. For example, one study using the Respecting Choices program—an advance care planning model developed by Gunderson Health System that includes multiple stages of care planning involving patients, providers, and communities— demonstrated that a provider using patient education and staff training efforts can increase the extent to which individuals understand and complete advance directives. In addition, 12 studies suggested that providers use materials designed for specific groups, such as videos, for those with low literacy or information developed for those with specific medical conditions that can help individuals better understand and communicate their preferences with providers. Eleven studies and four stakeholders that represented providers and individuals nearing the end of life also suggested using an iterative advance care planning process, such as a process that would start with community education about advance directives, continue with increasingly specific discussions with providers as an individual’s health deteriorates, and culminate with the completion of increasingly specific documents, such as advance directives or medical orders, as an individual nears the end of life. Fifteen studies noted the importance of such planning when individuals are diagnosed with a major illness or impending loss of decision-making capacity so that the individuals can communicate their preferences with providers before they are unable to do so.

Providers may also use leading practices to better address challenges to documenting information about advance directives in order to help ensure the accuracy and the accessibility of this information in an individual’s medical record, according to the literature and stakeholder officials. For example, five studies found that using specific documentation methods, such as spreadsheets or electronic health record systems, can improve the accuracy—including quantity and quality—of the information about advance directives maintained in individuals’ medical records. Six studies also suggested that providers adopt electronic health record systems that, in addition to indicating whether individuals have an advance directive, could contain copies of the directives to ensure that individuals’ preferences are more easily accessible to providers and families, especially for individuals that may transfer from one provider to another.

Many Adults Have Advance Directives, but the Prevalence Varies by Provider Type, Demographics, and Over Time

Many adults in the United States have advance directives. In 2013, about 47 percent of adults over the age of 40 had an advance directive, according to IOM’s report Dying in America. In addition, an earlier nationally representative survey that included younger adults age 18 and older found that an estimated 26 percent of this population had an advance directive during the 2009 and 2010 time period.

The prevalence of individuals with advance directives varies by the type of provider that individuals are served by—hospitals, nursing homes, HHAs, and hospices—according to the literature. For three of these four provider types (hospice, nursing homes, and HHAs), a 2011 National Center for Health Statistics report found that 88 percent of discharged hospice patients in 2007 had advance directives, compared to 65 percent of nursing home patients in 2004, and 28 percent of HHA patients in 2007. (See fig. 1.) Among the four covered provider types for which information was available, our analysis of 12 studies found that hospital patients were least likely to have advance directives and that hospice patients, who are by definition close to the end of life, were the most likely to have advance directives as compared with nursing home and HHA patients. We did not find peer reviewed studies in our literature review on the prevalence of those with advance directives among individuals enrolled in MA and Medicaid managed care plans, although these individuals may also be served by the other four covered provider types.

In addition to variations by provider type, the prevalence of advance directives also varies among individuals based on certain demographic characteristics, such as medical conditions including chronic and life threatening diseases, according to the literature. For example, in 2010, individuals 18 years of age and older with chronic diseases were more likely than those without such diseases to have advance directives, with an estimated 33 percent and 22 percent prevalence, respectively. (See fig. 2.) A total of 20 studies found that individuals with certain medical conditions were more likely to have advance directives than healthier individuals. In general, certain medical conditions—such as diabetes, malignancies, renal dysfunction, dementia, or declining health—increased the likelihood that individuals had advance directives, according to the literature.

The prevalence of advance directives also varies by age, race, income, education, and gender, according to the literature. Older individuals were more likely to have advance directives than younger individuals. For example, a 2009 and 2010 nationally representative survey found that an estimated 51 percent of individuals 65 years of age and older had advance directives, while among individuals 18 to 34 years old, an estimated 12 percent had advance directives. The survey also indicated that an estimated 31 percent of whites compared to an estimated 17 percent of African Americans or Latinos had advance directives. In addition, this study found that an estimated 32 percent of individuals with incomes of $75,000 or more had advance directives in comparison to an estimated 21 percent of those with incomes under $25,000. Similarly, prevalence among individuals with post-graduate educations compared to those who had not completed high school was an estimated 38 percent and an estimated 14 percent, respectively, according to the study. Women were also more likely to have advance directives than men, an estimated 28 percent versus 25 percent, according to the study. In addition to this study, 36 studies found variations in the prevalence of advance directives by age, race, income, education, or gender.

The prevalence of advance directives has been increasing over time, according to the literature and CMS data. For example, prevalence within the older population has increased over time, according to a study examining the prevalence of advance directives for those 60 years of age or older who died between 2000 and 2010. This study found that individuals 60 years of age and older who died during that period with an advance directive increased from an estimated 47 percent to 72 percent. Available information on nursing home residents also shows an increase over time. Our analysis of CMS data found that the proportion of nursing home patients with advance directives has increased between 2004 and 2014. We found that the average percentage of nursing home patients who had an advance directive increased from 46 percent in 2004 to 55 percent in 2014, based on data from nursing homes that were surveyed during that time. (See fig. 3.) However, the percentage of nursing home residents having advance directives fluctuated over this period. Eight additional studies found increases in the prevalence of those with advance directives over time for a specific group, such as those from one state or type of provider. Factors that may have contributed to the increasing prevalence of individuals with advance directives over time, according to the literature, include community education efforts and provider staff training.

Agency Comments

We requested comments on a draft of this product from HHS. HHS provided technical comments, which we incorporated as appropriate.

We are sending copies of this report to the appropriate congressional committees, the Secretary of Health and Human Services, and other interested parties. In addition, the report will be available at no charge on the GAO website at http://www.gao.gov.

If you or your staff have any questions about this report, please contact me at (202) 512-7114 or DsouzaV@gao.gov. Contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this report. GAO staff who made key contributions to this report are listed in appendix I.

Appendix I: GAO Contact and Staff Acknowledgments

GAO Contact

Staff Acknowledgements

In addition to the contact named above, James C. Musselwhite Jr., Assistant Director; George Bogart; Kye Briesath; Leia Dickerson; Julianne Flowers; Jennel Lockley; Drew Long; and Vikki Porter made key contributions to this report.