Additionally, the commenter added that independent living centers should develop relationships with HHAs and give these patients services beyond room and board. However, we do not believe it is appropriate to add language requiring hospitals to communicate the capabilities and limitation of PAC facilities to the patient and/or their caregivers, as this would be duplicative of the requirement at proposed § 482.43(c)(8), now finalized at § 482.43(a)(8). In addition, to further interoperability in post-acute care, CMS has launched the Data Element Library (DEL), which serves as a publicly available centralized, authoritative resource for standardized data elements and their associated mappings to health IT standards. documents in the last year, 1013 About the Federal Register We plan to issue sub-regulatory guidance that will discuss the circumstances of when a discharge or transfer summary would be expected at the time of discharge (and transfer if applicable), as in a discharge to home and community-based services (or a transfer to a PAC services facility such as a SNF), versus when it would not be appropriate to delay an emergency transfer as a result of waiting on the availability of a discharge summary. While we encourage, and even urge, collaboration with organizations such as CILs, AAAs, and ADRCs to assist patients with access to LTSS, we believe that mandating a collaborative relationship could be overly burdensome for hospitals. Comment: A few commenters offered recommendations regarding the use of certified health IT, EHRs, and “meaningful use” as described in our regulations at 42 CFR 495.22, and finalized in the FY 2018 IPPS/LTCH PPS final rule (82 FR 37990, 38517). In addition, as a best practice, CAHs should confirm patient or the patient's caregiver/support person (or both) understanding of the discharge instructions. While every effort has been made to ensure that Comment: Several commenters requested that we implement further requirements that specifically address delays in the discharge process for patients being referred for post-acute care services related to authorization for services, timely acceptance of patients by the PAC provider, and current payer contracts. New Documents We further believe that facilities, which are electronically capturing patient health care information, should be sharing that information electronically with health care providers that have the capacity to receive it to the extent they are authorized to do so. documents in the last year, 34 Commenters included individuals, health care professionals and corporations, national associations and coalitions, state health departments, patient advocacy organizations, and individual facilities that would be impacted by the rule. Throughout this final rule, we clarify that where the term “hospital” is used, we are referring to the aforementioned hospital classifications. For each entity that reviews the rule, the estimated cost is therefore $856 (4 hours each × 2 staff × $107 per hour each). For further information about other nondiscrimination laws see http://www.hhs.gov/​civil-rights. If the transfer was unplanned, the HHA must send a completed transfer summary within 2 business days of becoming aware of the unplanned transfer, only if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. We agree that this issue warrants further study and a better developed evidence base before we proceed further with rulemaking. We are committed to publishing a final rule that provides clear health and safety standards for hospitals, HHAs, and CAHs. TTY users can call 1-877-486-2048. This applies to patients discharged to an acute care setting. In accordance with Executive Order 13813, which promotes healthcare choice and competition across the country, and in line with HHS' goals to improve interoperability between patients and their health care providers, we are finalizing certain discharge planning requirements for hospitals (including Short-Term Acute-Care Hospitals, LTCHs, Rehabilitation Hospitals, Psychiatric Hospitals, Children's Hospitals, and Cancer Hospitals), HHAs, and CAHs as well as finalizing the hospital patients' rights requirement regarding patient access to medical records. I … These markup elements allow the user to see how the document follows the We also proposed at § 484.58(a)(6) that HHAs provide data on quality measures and resource use measures to the patient and caregiver that are relevant to the patient's goals of care and treatment preferences. However, while an emergency-level transfer would not need a discharge evaluation and plan, we would expect that the CAH would send necessary and pertinent information with the patient that is being transferred to another facility. In addition, the commenter recommended that CMS mandate that the referring facility ensure that the receiving facility has received the information. We are also finalizing the requirements of the IMPACT Act for hospitals, HHAs, and CAHs. Revising § 484.58(b)(1) to require that, instead of a specified list, the HHA must send necessary medical information pertaining to the patient's current course of illness and treatment, post-discharge goals of care, and treatment preferences to the receiving facility or health care practitioner to ensure the safe and effective transition of care. We continue to believe that there are instances in which the receiving health care practitioner or facility would request additional information beyond that which the HHA provided in the discharge or transfer summary, such as the patient's actual plan of care. Response: We believe that the 60-day comment period was sufficient, as evidenced by the number of comments we received. However, most commenters disagreed with certain, specific proposed discharge planning requirements. The commenter believes that it would take 10 to 15 minutes, not 5, for a nurse or therapist to assemble all of the information, review the medication list for accuracy, review the goals for completeness, and draft the recommendations for care following discharge. However, we agree with commenters that this information is not automatically necessary for each and every HHA patient discharge or transfer. Therefore, the estimates we provide in the RIA section of this final rule are essentially identical to those we would estimate under the PRA with respect to the elements set out in section 1899B of the Act. In addition, as we previously explained, there may be significant additional health benefits, such as the reduction in patient readmissions after discharges and the reduction of other post-discharge patient complications. Specifically, Congress directed that ONC “. Response: We have not estimated training costs since we believe that training related to changes in policies and procedures or to improve implementation of existing policies and procedures is an ongoing process in HHAs. One commenter recommended that CMS work with state PDMP programs to facilitate proactive PDMP report generation that could be sent to hospitals at the time of patient admission. This requirement will be included in § 482.43(a)(3). Comment: A few commenters requested clarification on the definition of “the practitioner responsible for the care of the patient” in the proposed requirement that the practitioner responsible for the care of the patient be involved in the ongoing process of establishing the patient's goals of care and treatment preferences that inform the discharge plan, just as they are with other aspects of patient care during the hospitalization or outpatient visit. Such messaging could be done directly, or through an intermediary that facilitates exchange of health information, and would occur at the time of admission and immediately prior to or at the time of discharge or transfer. Document Drafting Handbook The current HHA CoPs at § 484.110 already require HHAs to send a discharge or transfer summary to the receiving provider, so the software used by HHAs to complete this task already exists. We do not believe that it is necessary to define the term, as it does not have a special meaning in this rule. Instead, we are finalizing requirements at § 482.43(a) introductory text and (a)(2), respectively, that would require that a hospital's discharge planning process must identify, at an early stage of hospitalization (ideally when the patient is admitted as an inpatient, or shortly thereafter), those patients who are likely to suffer adverse health consequences upon discharge in the absence of adequate discharge planning and must provide a discharge planning evaluation for those patients so identified, as well as for other patients upon the request of the patient, patient's representative, or patient's physician. We note that the proposed rule would have shown total information collection burden costs of over $550 million annually had this estimate been more realistic in the Discharge proposed rule. Require that, if the caregiver contacts the provider after the discharge planning process has begun, that individual must be involved in the discharge planning process. Although we proposed to modify this currently existing requirement to include IRFs and LTCHs, in order to be consistent with the provisions of the IMPACT Act, we expect the discharge planner to facilitate patient choice in any post hospital extended care services as part of the discharge planning process. Response: We expect hospitals, HHAs, and CAHs to document the patient's refusal in the medical records and continue to make reasonable efforts to work with the patient and/or the patient's caregiver to find appropriate substitutions. We proposed to re-designate and revise the current standard at § 482.43(d) as § 482.43(e), “Transfer of patients to another health care facility,” by clarifying our expectations of the discharge and transfer of patients. The commenter recommended that CMS explicitly state which Start Printed Page 51839provider types would be required to comply with the discharge planning CoPs. We estimate that the administrator will spend 8 hours on this activity for a total of 8 hours per HHA at a cost of $856 (8 hours × $107 for an administrator's hourly salary). The hospital must provide a discharge planning evaluation for those patients so identified as well as for other patients upon the request of the patient, the patient's representative, or patient's physician. As we discuss in detail in the subsequent sections of this final rule, we also align, where appropriate, and as informed by the public comments, our final discharge planning requirements for hospitals (and CAHs) with the mandates in section 1861(ee)(1) of the Act. documents in the last year. We proposed at § 485.642(c)(9) to require that the evaluation of the patient's discharge needs and discharge plan would have to be documented and completed on a timely basis, based on the patient's goals, preferences, strengths, and needs. Responses to comments received for this section can be found in section VI “Regulatory Impact Analysis” of this final rule. We are issuing this document in accordance with section 1871(a)(3)(B) of the Social Security Act (the Act), which requires notice to be provided in the Federal Register if there are exceptional circumstances that cause us to publish a final rule more than 3 years after the publication date of the proposed rule. While every effort has been made to ensure that The commenter noted that while it is essential to know a patient's medical and treatment history, the discharge summary requirement does not make sense if information is being sent when the transfer is from the “doctor to him or herself” and from the “nurse to the same nurse.” The commenter further pointed out that this may be an issue in rural communities, where the practitioners are the same on either side of the transfer. headings within the legal text of Federal Register documents. Specifically, we noted that CMS will consider revisions to the current CMS CoPs for hospitals such as: Requiring that hospitals transferring medically necessary information to another facility upon a patient transfer or discharge do so electronically; requiring that hospitals electronically send required discharge information to a community provider via electronic means, if possible and if a community provider can be identified; and requiring that hospitals make certain information available to patients or a specified third-party application (for example, required discharge instructions) via electronic means if requested. Response: We have revised this requirement to remove a number of items that were proposed to be included as part of what many commenters described as an overly and unnecessarily prescriptive list of patient medical information that was to be sent. In recent years, we have revised the CoPs and Cf Cs to reduce the regulatory burden on providers and suppliers. Response: We appreciate the comment on various professionals who may be involved in the discharge planning process. We proposed at § 484.58(b) to establish a new standard, “Discharge or transfer summary content,” to require that the HHA send necessary medical information to the receiving facility or health care practitioner. documents in the last year, 348 Revising §§ 482.43 and 485.642, respectively, to now require that the hospital (or CAH) must have an effective discharge planning process that focuses on the patient's goals and preferences and includes the patient and his or her caregivers/support person(s) as active partners in the discharge planning for post-discharge care. In addition, providing patients with a list of providers that responded within an allotted period of time would not assist the patient in making a decision, as it may unduly limit patient choice based on an arbitrary time deadline. As described earlier, we are not finalizing the proposed discharge planning process requirements of § 484.58(a), with the exception for those IMPACT Act requirements set forth in proposed paragraph (a)(6). However, we do not expect providers to have definitive knowledge of the terms of a patient's insurance coverage or eligibility for post-acute care, or for Medicaid coverage, but we encourage providers to be generally aware of the patient's insurance status. 3501 et seq.). We believe that providing additional information, upon request, to follow-up care providers is a standard practice for 90 percent of HHAs. However, these documents (and, by extension, the entire medical record) would obviously not be complete until after a patient is discharged. In fact, we expect that facilities, which are already electronically capturing patient health care information, are also electronically sharing that information with providers that have the capacity to receive it to the extent such release is permitted under HIPAA. The Medicare Conditions of Participation (CoPs) and Conditions for Coverage (CfCs) set forth the federal health and safety standards that providers and suppliers must meet to participate in the Medicare and Medicaid programs. Once a patient is connected with a community based organization, such as an ADRC, AAA, or CIL, the responsibility for ensuring that the patient is actually receiving non-health care services, including home modifications, becomes that of the community based organization and the community provider of the services and supports. Preparation of patients and caregivers to be active partners in post-discharge care; effective transition of the patient from HHA to post-HHA care; and. Response: With regard to the suggestion that CMS should mandate what discharge instructions must include, we agree, and as part of the HHA CoP final rule, we require that HHAs provide patients with key information, such as information regarding medications and services provided, throughout the patient's duration of home health care (§ 484.60(e)). Register (ACFR) issues a regulation granting it official legal status. Conditions of Participation (CoP)—Discharge Planning (Proposed § 482.43), 5. Thus, we believe that CAHs are already following most of these requirements and therefore we will not be assessing any additional burden for this section beyond our estimate in the RIA of the one-time cost to CAHs to modify their policies and procedures in order to ensure that they are meeting the requirements of this rule. Response: We agree that the proposed list could be burdensome, and, therefore, we are not finalizing it in this final rule. The CoPs do not bar providers from sending all additional appropriate medical information regarding the patient's current course of illness and treatment, post-discharge goals of care, and treatment preferences in accordance with applicable laws. However, we do not agree that this should be a requirement for all hospitals and CAHs. documents in the last year, 73 The commenter stated that the HHA's primary consideration with regard to family caregivers is their willingness to provide services to an ill, disabled or frail elderly individual. Several commenters questioned whether relevant hospital practitioners were qualified to interpret, discuss, and answer questions about the quality and resource use data. documents in the last year, 1013 The hospital's discharge planning process must identify, at an early stage of hospitalization, those patients who are likely to suffer adverse health consequences upon discharge in the absence of adequate discharge planning and must provide a discharge planning evaluation for those patients so identified as well as for other patients upon the request of the patient, patient's representative, or patient's physician. We discuss the comments we received and our responses in section II.B of this final rule. The commenter further stated that CMS could collect data on how many all-cause readmission beneficiaries have dementia. We would expect acute care providers that collect data electronically to provide this information in an electronic format to HHAs that have the capacity to receive such electronic information and incorporate it into their EHRs. We note that providers can and should send all additional medical information pertaining to the patient's current course of illness and treatment, post-discharge goals of care, and treatment preferences. In order to increase patient involvement in the discharge planning process and to emphasize patient preferences throughout the patient's course of treatment, we expect that CAHs tailor the data on PAC provider quality measures and resource use measures to the patient's goals of care and treatment preferences. Response: This comment does not pertain to any specific proposed changes to the discharge planning policy proposals set forth in the Discharge Planning proposed rule. Comment: Several commenters recommended that hospitals use the National CLAS Standards for guidance on providing instructions in a culturally and linguistically appropriate manner and also recommended the use of the “teach-back” method to confirm the patient's or the patient's caregiver/support person's (or both) understanding of the discharge instructions. Medicare and Medicaid Programs; Revisions to Requirements for Discharge Planning for Hospitals, Critical Access Hospitals and Home Health Agencies resenting the nation’s nearly 50,000 hospitalists, is extremely interested in the. Response: We continue to strive to promote successful transitions of care between health care settings and believe that the transition of the patient from one environment to another should occur in a way that promotes efficiency and patient safety through the communication of necessary information between the hospital and the receiving facility. The commenter Start Printed Page 51869further noted that patients rarely consult with their current agency on the quality of a competitor. Register documents. We refer readers to section II.E.7 of this final rule for a more detailed discussion of this requirement. In the HHA CoP final rule we implemented a new requirement that HHAs must assess a caregiver's willingness and ability to provide care as part of the comprehensive patient assessment. The impracticality and potential ineffectiveness of such a list of mandatory discharge or transfer summary elements developed in the absence of public consensus and evidence-based practices would not improve patient care and safety, nor would it assure the efficient use of HHA resources. The President of the United States issues other types of documents, including but not limited to; memoranda, notices, determinations, letters, messages, and orders. Response: Although we frequently assess the need to update the CoPs, section 2(a) of the IMPACT Act, adding subsection 1899B(i) to the Act, requires us to update the CoPs and subsequent interpretive guidance for hospitals, CAHs, and PAC providers periodically, but not less frequently than once every 5 years. It is just as important for the receiving health care practitioner to be sent the discharge information as it is for the HHA to receive such information from the patient's previous care provider. We greatly appreciate the detailed comments we received and the regulatory improvements that they recommended. Discharge to Home (Proposed § 485.642(d)(1) through (3)), 5. 1302, 1395hh, 1395rr, and 1395lll unless otherwise noted. We do not agree with changing the terminology currently used in this rule because we are using the most widely accepted and recognized terminology in the medical industry. However, this section would be revised to include IRFs and LTCHs. Comment: Commenters supported the proposal to require the discharge plan to identify any HHA or SNF to which the patient is referred in which the hospital has disclosable financial interest. Commenters recommended that only a discharge order from the primary care physician be required, and that the physician should receive a copy of the discharge summary to follow-up with the patient as appropriate. Comment: One commenter questioned if there should be a requirement for the hospital to use reasonable efforts to determine the identity of the practitioner(s) responsible for the follow-up care of the patient being discharged to home, and to communicate with that practitioner. One commenter stated that CMS's “Compare” websites can be confusing for patients and would likely require case management professionals to filter and interpret the data. by the Internal Revenue Service Recommendations to minimize the information collection burden on the affected public, including automated collection techniques. For all hospitals to comply with this requirement, we estimate a total one-time cost of approximately $17.7 million (4,900 hospitals × $3,604 ($1,680 plus $568 plus $544 plus $812 = $2,780)). The evaluation to determine a patient's continued hospitalization (or in other words, their readiness for discharge or transfer), is a current standard medical practice, and additionally is a current hospital CoP requirement at § 482.24(c). Executive Order 13132 establishes certain requirements that an agency must meet when it issues a proposed rule (and subsequent final rule) that would impose substantial direct requirement costs on state and local governments, preempt state law, or otherwise have federalism implications. The continuing annual costs (survey process-recertifications, enforcement by states or accredited organizations, appeals, AO) will not change from current levels. Proposed § 482.43(c)(5): We proposed to require that, as part of identifying the patient's discharge needs, the hospital consider the availability of caregivers and community-based care for each patient. In addition, these regulations will implement the discharge planning requirements of the IMPACT Act, which will empower patients to be active participants in the discharge planning process, which will require providers to give patients more information as they choose a PAC provider. In response to the commenter's request for clarification regarding partial hospitalization services and intensive outpatient services at hospitals, we note that these services can be provided in a hospital outpatient department, and partial hospitalization services can be provided in a community mental health center. In light of the significant streamlining of the final discharge planning requirements for HHAs, we do not believe an additional delay in the effective date for implementation of the final discharge planning requirements for HHAs, including the Impact Act requirements at § 484.58(a) are necessary. The location to which a patient may be discharged should be based on the patient's clinical care requirements, available support network, and patient and caregiver treatment preferences and goals of care. We proposed at § 485.642(c)(7) to require that the patient's discharge plan address the patient's goals of care and treatment preferences. Commenters also stated that hospitals have little control over the time it takes for PAC providers to accept patients once they have been notified of the need for services. The Centers for Medicare and Medicaid Services (CMS) Nov. 3 released the Revisions to Requirements for Discharge Planning for Hospitals, Critical Access Hospitals, and Home Health Agencies proposed rule.Comments on the rule are due by Jan. 4, 2016. Similarly, this requirement that a patient's necessary medical information must be transferred at the time of discharge (and transfer or referral as Start Printed Page 51857applicable) to the appropriate post-acute care service providers and suppliers, facilities, agencies, and other outpatient service providers and practitioners responsible for the patient's follow-up or ancillary care would also include dialysis facilities, dialysis units, and nephrologists for those patients where this is relevant and appropriate. corresponding official PDF file on govinfo.gov. More information and documentation can be found in our In light of these challenges and for the reasons set forth above, we are not finalizing a list of items to be included in every discharge or transfer summary. The commenter recommended that CMS modify the language used in the rule and clarify that the patient's goals and preferences must be considered during the discharge planning process, but that it is ultimately the decision of the practitioner responsible for the care of the patient whether the goals and preferences can be incorporated into the discharge plan. Response: Comments regarding LTC facilities and Medicaid demonstration programs are outside the scope of this final rule. Track the patients at discharge agreed to be collected patient resource to assist patients should be “ involved the! Believed the inclusion of consultations and procedures performed by other facilities this repetition of headings to internal. 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