As part of the on-going discharge planning process, we proposed in § 485.642(c)(5) that CAHs would need to identify areas where the patient or caregiver/support person(s) would need assistance and address those needs in the discharge plan. (2) The HHA must comply with requests for additional clinical information as may be necessary for treatment of the patient made by the receiving facility or health care practitioner. Comment: One commenter stated that not all of the information in the plan of care and latest physician orders may be relevant at the time of discharge. 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. However, most commenters who made suggestions related to this section expressed concern about the burden of the proposed design requirement and whether those burdens outweighed any potential, though not proven, benefits of the requirements. on Proposed § 482.43(d)(4): We proposed to require, for patients discharged to home, that the hospital establish a post-discharge follow-up process. We believe that our interpretation is consistent with the BBA provision. In addition, we proposed at § 484.58(a)(7) to require that the evaluation of the patient's discharge needs and discharge plan be documented and completed on a timely basis, based on the patient's goals, preferences, and needs, so that appropriate arrangements are made prior to discharge or transfer. The public comment period on the proposed rule gave those affected an equivalent opportunity with the greater procedural benefits of the Administrative Procedure Act and Executive Order 12866. The commenter stated the hospital CoP proposed language at § 482.43(c)(1), requires that a “registered nurse, social worker, or other qualified personnel must coordinate the discharge needs evaluation and development of the discharge plan.” The commenters recommend that a comparable requirement be included in the HHA CoPs, as it would help clarify the respective roles of HHA staff and the patient's physician. Response: We appreciate the wide array of comments related to the Start Printed Page 51868proposed requirement at § 484.58(b). The hospital must discharge the patient, and also transfer or refer the patient where applicable, along with all necessary medical information pertaining to the patient's current course of illness and treatment, post-discharge goals of care, and treatment preferences, at the time of discharge, 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. A few commenters questioned the use of the Nursing Home Compare and Home Health Compare websites. 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. A final rule revises and implements discharge planning requirements that hospitals, critical access hospitals (CAHs), and home health agencies (HHAs) must meet as a condition of participation (CoP) in the Medicare and Medicaid programs. Specifically, the proposed rule builds on the Common Clinical Data Set with the U.S. Revising and redesignating proposed § 482.43(a), (b), and (c) as § 482.43(a) “Discharge planning process.” As revised, § 482.43(a) will incorporate and combine provisions of the current hospital discharge planning requirements (some of which are statutorily required for hospitals) with revised elements contained within some provisions of the proposed requirements at § 482.43(c). We proposed that each CAH's discharge planning process ensure that the discharge needs of each patient were identified and resulted in the development of an appropriate discharge plan for each patient. We believe that post-discharge follow-up can help ensure that patients comprehend and adhere to their discharge instructions and medication regimens and improve patient safety and satisfaction. Removing § 482.43(a), (b), and (c), respectively and § 485.642(a), (b), and (c), and replacing these standards with revised and redesignated standards at §§ 482.43(a) and 485.642(a), respectively, entitled “Discharge planning process” for each section. Other commenters believe CMS should have added several of the provisions under the hospital Discharge Planning proposed rules to the home health proposed requirements. 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. We note that the Emergency Preparedness final rule requires health care facilities to communicate with state and local officials during a disaster (81 FR 63860, September 16, 2016). We also remind providers of their obligations take reasonable steps to provide meaningful access to individuals with limited English proficiency in accordance with Title VI of the Civil Rights Act of 1964 and section 1557 of the Patient Protection and Affordable Care Act (the Affordable Care Act). CAHs are to ensure that adequate patient health records are maintained and transferred as required when patients are referred. Comment: We received numerous comments regarding the requirement for hospitals and CAHs to provide specific information to a receiving facility during a transfer. One commenter questioned whether these hospitals would be required to check all state databases that are in their surrounding area. These changes show both the benefits of the public comment process under the Administrative Procedure Act, and the focus of CMS in developing final rules in complying with the goals of the laws and Executive Orders previously discussed, especially Executive Orders 12866, 13563 and 13771. Finally, we generally consider the exchange of information between facilities using an EHR system the same as “sending” information from one facility to another, except under those circumstances when we explicitly require use of a physical record. Any burden associated with the changes to the CoPs not accounted for in the ICR section or in the RIA section was omitted because we believe it would constitute an usual and customary business practice and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). We recommended that CAHs consider the use of “teach-back” techniques during discharge planning and upon providing discharge instructions to the patient. This broad, flexible requirement allows HHAs to tailor the exchange of information to the exact circumstances and needs of the care transition in order to support the patient's post-discharge goals. We estimate that an administrator will spend 8 hours on this activity for a total of 8 hours per hospital at a cost of $1,680 (8 hours × $210 for an administrator's hourly salary cost), together with an RN or equivalent for an additional 8 hours at a cost of $568 (8 hours × $71 for an RN salary cost). Additional explanations, resources, instructions, and help on how to use the IRF Compare, HH Compare, Nursing Home Compare, and Long-Term Care Hospital Compare websites are currently available on the following pertinent websites: While the data from these sources are not available in “real time,” the data are posted as soon as feasible. The discharge plan must be updated, as needed, to reflect these changes. Mandate that providers collaborate and coordinate with community based organizations on the availability of community supports at discharge. Comment: One commenter stated that many rural Americans live in areas with limited health care resources, restricting their available options for care, including post-acute care options. The Centers for Medicare & Medicaid Services today issued final rules reducing some regulatory burdens for providers participating in the Medicare and Medicaid programs, and revising discharge planning requirements for hospitals, critical access hospitals and home health agencies. For all HHAs to comply with this requirement, we estimate a total one-time cost of approximately $10.8 million (12,600 HHAs × $856). These are only a fraction of those dealing with costs or burdens that are already addressed in the preamble. regulatory information on FederalRegister.gov with the objective of (6) The hospital's discharge planning process must require regular re-evaluation of the patient's condition to identify changes that require modification of the discharge plan. (See 45 CFR 164.524). The regulations text, as written, does not explicitly state who must provide the list of PAC providers to the patient or their representative. 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. While we continue to believe that much of the information we proposed should be exchanged for patients to whom it applies, as well as many of the additional suggestions we received, we are requiring a less prescriptive and more flexible set of requirements. Response: While we continue to believe that a post-discharge follow-up process has value for certain patients, for the reasons we gave in the proposed rule (80 FR 68135), we have decided to remove this requirement from this final Start Printed Page 51858rule since we believe that most hospitals are already doing this according to their specific situations and patient populations, and patient risk levels. One comment suggested that hospitals and CAHs should be required to use a risk-stratification approach (that is, an approach for identifying and predicting which patients are at high risk, or likely to be at high risk, and prioritizing the management of their care in order to prevent worse outcomes) among the elements of a hospital's discharge planning policies and procedures. While Medicare and Medicaid Conditions of Participation (CoPs) previously required hospitals to have discharge planning processes in place, the Final Rule extends this requirement to … Register (ACFR) issues a regulation granting it official legal status. and within a reasonable time frame.”. documents in the last year, 10 Furthermore, the IMPACT Act requirements will give patients and their families access to information that will help them to make informed decisions about their post-acute care, while addressing their goals of care and treatment preferences. A few commenters recommended that CMS give providers more information and guidelines on how to discuss PAC data on quality measures and data on resource use measures with patients. Require that caregivers be notified in advance of the individual's discharge in order to ensure a safe and appropriate discharge back to the community. Comment: Most commenters supported the proposed requirement that hospitals send a copy of the discharge instructions and the discharge summary, pending test results, and other necessary information to the practitioner(s) responsible for follow-up care, if the practitioner is known and has been clearly identified, and cited the importance of this information for these practitioners. Finally, HHAs also obtain periodic changes in payment rates from both public and private payers. Response: We appreciate the support for the proposed regulations. While pending test results clearly would be included as part of a patient's necessary medical information that we are requiring be sent upon discharge to facilities and practitioners providing PAC and follow-up services to the patient, we also recognize that the very nature of these test results being “pending” precludes them from being sent at that time and hospitals would not be held accountable for sending information that they simply do not have at the time of discharge. We believe these requirements will afford patients the opportunity to Start Printed Page 51840be active participants in the discharge planning process. In the Discharge Planning proposed rule, we encouraged providers to consider using their state's Prescription Drug Monitoring Program (PDMP) during the evaluation of a patient's relevant co-morbidities and past medical and surgical history (80 FR 68132). Comment: We received several comments related to the content and implementation of the proposed discharge instructions requirement. This extension is effective on November 2, 2018. However, we must note here again that a patient's dialysis care plan information is part of his or her necessary medical information. Currently, the CoPs at § 485.631(c)(2)(ii) provide that a CAH must arrange for, or refer patients to, needed services that cannot be furnished at the CAH. One commenter recommended that the regulation specify that discharge planning documents be immediately accessible to patients and their caregivers. Medicare and Medicaid Programs; Revisions to Requirements for Discharge Planning for Hospitals, Critical Access Hospitals, and Home Health Agencies, 68125-68155 [2015-27840] Include specific references to CILs, ADRCs, and AAAs in the regulation and provide patient instructions on their use. We also note that we are not requiring hospitals and CAHs to ensure that the receiving facility has received the information on a patient's discharge because such a requirement would be overly burdensome. The Office for Civil Rights recently issued Frequently asked Questions document about medical records access clarifying that the requirement to send medical records to the individual is within 30 days (or 60 days if an extension is applicable) after receiving the request, “however, in most cases, it is expected that the use of technology will enable the covered entity to fulfill the individual's request in far fewer than 30 days.” (See http://www.hhs.gov/hipaa/for-professionals/privacy/guidance/access/#newlyreleasedfaqs.) on In order to demonstrate compliance with a proof of collaboration requirement like the one recommended here by some commenters, hospitals would need to provide extensive documentation solely for Medicare certification and participation purposes. documents in the last year, 308 More information and documentation can be found in our Medicare and Medicaid Programs; Revisions to Requirements for Discharge Planning for Hospitals, Critical Access Hospitals, and Home Health Agencies; Extension of Timeline for Publication of Final Rule CMS proposes to require that home health agencies develop and implement an effective discharge planning process as a Medicare Condition of Participation (CoP). We note that many of these PAC provisions are being addressed in separate rulemakings. Centers for Medicare & Medicaid Services Department of Health and Human Services P.O. Commenters expressed their belief that CMS should allow providers to identify the best PAC providers that lead to improved efficiency and better outcomes, so long as patients are given the ultimate choice of PAC provider and all financial dealings and conflicts of interest are disclosed to the patient during the discharge planning process. Comment: One commenter suggested that we develop a policy that would facilitate improved payer-provider collaboration and coordination with the discharge planning process so that managed care companies are also held to these same requirements. As previously noted, we recognize that there is significant benefit in improving the transfer and discharge requirements from an inpatient acute care facility, such as CAHs and hospitals, to another care environment. In addition, the commenter recommended that CMS mandate that the referring facility ensure that the receiving facility has received the information. Finally, we agree with commenters that a discharge planning evaluation and screening of patients who have discharge needs is a more appropriate approach to selecting patients for establishing a discharge evaluation. Final Decision: After consideration of the comments we received on the proposed rule, we are finalizing the first sentence in the introductory paragraph Start Printed Page 51849of § 482.43 with minor modifications, to state that the hospital must have an effective discharge planning process that focuses on the patient's goals and treatment preferences and includes the patient and his or her caregivers/support person(s) as active partners in the discharge planning for post-discharge care. The particular staff involved in such a review will vary from provider to provider. 7. 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. Additionally, the requirement at § 482.13(a)(2), under the Patient's Rights CoP for hospitals, requires the hospital to establish a process for prompt resolution of patient grievances and must inform each patient whom to contact to file a grievance. Mandated spending for CAHs, in contrast, is largely reimbursed on a cost basis and would not count as an unfunded mandate even in early years. rendition of the daily Federal Register on FederalRegister.gov does not 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. The IMPACT Act requirements are being finalized at § 484.58(a).Start Printed Page 51867. The Centers for Medicare & Medicaid Services (CMS) has announced a one-year extension, until November 3, 2019, to publish the discharge planning final rule for home health agencies. We are instead finalizing a requirement at § 482.43(a)(2) that a discharge planning evaluation include an evaluation of a patient's likely need for appropriate post-hospital services, including, but not limited to, hospice care services, post-hospital extended care services, home health services, and non-health care services and community based care providers, and that the evaluation must also include a determination of the availability of the appropriate services as well as of the patient's access to those services. The President of the United States communicates information on holidays, commemorations, special observances, trade, and policy through Proclamations. Comment: One commenter suggested that CMS should require utilization of independent living centers instead of nursing homes for moderately functioning patients. Section 1871(a)(3)(A) of the Social Security Act (the Act) requires the Secretary of the Department of Health and Human Services (the Secretary), in consultation with the Director of the Office of Management and Budget (OMB), to establish a regular timeline for the publication of a final rule based on the previous publication of a proposed rule or an interim final rule. Dear Mr. Slavitt: AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. Comment: Many commenters recommended a delay in the implementation or the effective date of the final discharge planning requirements for all providers. Comment: One commenter stated that hospitals should be required to document the actual list of post-acute care referrals presented to the patient as a means for surveyors to determine the adequacy of the post-discharge options presented to the patient. We proposed at § 484.58(a)(4) to require that the patient and caregiver(s) must be involved in the development of the discharge plan, and informed of the final plan. 1 to 5 years, with several commenters specifically recommending a 1-year delay; Piloting discharge planning requirements before finalizing them; A 2-year delay with implementation to begin with inpatients that hospitals determine are most at risk for readmission. Start Printed Page 51848Some commenters suggested allowing hospitals to provide to the patient copies of their medical record in the format that the facility deems appropriate at the time of the request if the patient has not specified a format for receiving the records. However, other commenters stated that the proposed requirements that a hospital must consider in evaluating a patient's discharge needs are overly prescriptive and overly detailed. Revising § 484.58(b)(1) to require the HHA to 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. Comment: A few commenters asked about the role that Prescription Drug Monitoring Programs (PDMPs) should play in the discharge planning process. We proposed at § 485.642(c)(8) to require that CAHs assist patients, their families, or caregivers in selecting a PAC using IMPACT Act quality measures. Furthermore, we believe that facilities that are electronically capturing information should be exchanging that information electronically with providers who have the capacity to accept it. Ultimately, these final requirements will ensure that a patient's health care information follows them after discharge from a hospital or PAC provider to their receiving health care facility, whether that be their primary care physician or a SNF. We estimate that this rule will impose annualized costs of approximately $175 million discounted relative to 2016 over a perpetual time horizon. Finally, a few commenters were against new discharge planning requirements altogether. Comment: One commenter requested that we clarify that one way HHAs could demonstrate compliance with the proposed requirement to involve physicians in discharge planning is by documenting any outreach to the physician to coordinate his or her involvement. Comment: Several commenters disagreed with our estimates on the amount of time that it would take an HHA to develop a discharge plan per patient. These can be useful documents in the last year, 643 The CAH has the flexibility to determine and identify other personnel qualified to coordinate the discharge planning evaluation and development of the discharge plan. We therefore remind providers that they must continue to abide by all applicable state laws. 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. Additionally, we would also like to point out that in those hospitals and CAHs where there are multiple licensed and qualified practitioners responsible for the care of the same patient, delay of the discharge, and transfer or referral where applicable, of the patient, along with his or her necessary medical information, should not occur as a result of “waiting” for a specific provider's signature, either written or electronic, on the discharge order and the discharge or transfer summary for the patient. 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 all three cases, we have no way to predict precise future pathways or exact timing however, we believe that most of the recurring costs will be recovered through payments from third party payers, public and private. 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