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. 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 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.