Many stated that they believe that the current evaluation requirement is effective for screening and targeting high-risk patients who have true discharge needs. The commenter further recommended that, in discussions of what support a family caregiver may need, his or her economic resources should be taken into account. We were particularly interested in identifying fundamental barriers to interoperability and health information exchange, including those specific barriers that prevent patients from being Start Printed Page 51843able to access and control their medical records. Commenters recommended the following: Response: We appreciate the commenter's concerns regarding the inclusion of the patient's caregiver during the discharge planning process. Comment: Several commenters stated that the rural location and small size of CAHs pose difficulties for them in ensuring that they have the appropriate staff available to implement the discharge planning requirements. This reduction of costs by more than half reflects some downward re-estimates, but mainly our efforts to remove overly prescriptive and costly process requirements that had originally been proposed. Section 485.642(b) provides that the CAH 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.Start Printed Page 51874. While every effort has been made to ensure that CMS Proposes Conditions of Participation for Rural Emergency Hospitals, Updates for Critical Access Hospitals. We proposed at 482.43(c)(8), to require that hospitals assist patients, their families, or their caregivers/support persons in selecting a PAC provider by using and sharing data that includes, but is not limited to, HHA, SNF, IRF, or LTCH data on quality measures and data on resource use measures. Response: We agree that considering a patient's DME needs when planning for a patient's post-hospital care is a best practice. To receive or maintain their certification, hospitals must meet all CoPs, making CoP compliance essential to hospital operations. In response to the Hospital Innovation proposed rule, we received 200 public comments, of which a small portion were centered on the proposed patient's right to access his or her own medical information requirement. 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)). We estimate that it will take 15 minutes to process each request and either print and fax, or otherwise send the additional requested documentation, for a total of 45,000 hours per year (180,000 requests .25 hours per request) at a cost of $1,485,000 (45,000 hours $33 general office clerk hourly rate). Providers may utilize the appropriate practitioners that they believe will effectively conduct a patient's discharge planning process. We would continue to require that all hospitals communicate necessary information of patients who are discharged with transfer to another facility. 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. The HHA must advise the patient, representative (if any), the physician(s) issuing orders for the home health plan of care, and the patient's primary care practitioner or other health care professional (if any), who will be responsible for providing care and services to the patient after discharge from the HHA, that a discharge for cause is being considered. Additionally, the commenter added that independent living centers should develop relationships with HHAs and give these patients services beyond room and board. It was also not our intent to potentially strain HHA-physician relationships. Final Decision: After consideration of the comments we received on the proposed rule, we are not finalizing the proposed design requirements at 482.43(a). Response: We understand the commenter's concerns about a repetitive or time consuming process for rural or small hospitals or CAHs, particularly when the services being provided to the patient changes from acute inpatient to swing bed. We refer readers to section II.E.7 of this final rule for a more detailed discussion of this requirement. We believe that these ongoing efforts to educate, train, and otherwise engage caregivers throughout the continuum of HHA care meet the needs of caregivers in preparing for discharge. Another commenter recommended that each state expand the number of nursing facility/acute hospital Medicaid demonstration programs that will allow individuals with disabilities to live in the community. Comment: Many commenters stated that we underestimated the implementation cost for the proposed requirements for hospitals and, particularly, CAHs. 801 et seq. The assessment must include ongoing, periodic review of a representative sample of discharge plans, including those patients who were readmitted within 30 days of a previous admission, to ensure that the plans are responsive to patient post-discharge needs. The discharge planning process and the discharge plan must be consistent with the patient's goals for care and his or her treatment preferences, ensure an effective transition of the patient from hospital to post-discharge care, and reduce the factors leading to preventable hospital readmissions. Response: Comments related to provider reimbursement are outside the scope of this final rule. Furthermore, all relevant patient information available to or generated by the HHA itself must be incorporated into the discharge plan to facilitate its implementation and to avoid unnecessary delays in the patient's discharge or transfer. The statutory timing of the IMPACT Act varies for the standardized assessment data described in subsection (b) of the Act, data on quality measures described in subsection (c) of the Act, and data on resource use and other measures described in subsection (d) of section 1899B of the Act. The discharge planning requirements for SNFs were addressed in the Long-Term Care (LTC) Facility Requirements final rule (81 FR 68688, October 4, 2016) and 483.21(c) of the SNF requirements, which addresses discharge planning. In regards to the commenters' concerns about specific proposed requirements, we refer readers to the specific provider sections and the specific provisions throughout the preamble of this final rule for a more detailed discussion of the final requirements and responses to the comments we received on the proposed rule. This prototype edition of the Specifically, Congress directed that ONC . One commenter suggested that LTC facilities and rehabilitation facilities have a social worker with a Master of Science in Management (MSM), Licensed Clinical Social worker (LCSW), or a Master's degree in Gerontology. Other commenters requested specific clarifications of potentially ambiguous terms, such as active partner, preventable readmissions, and effective transfers. However, many commenters expressed concern regarding the burdens that would be imposed upon HHAs, should the proposed requirements become final, particularly because they believe there is no evidence that engaging in the extensive discharge process that we proposed would improve patient safety, HHA-physician communications, or post-HHA care delivery. However, we must note here again that a patient's dialysis care plan information is part of his or her necessary medical information. The HHA must provide training, as necessary, to ensure a timely discharge. Therefore, we respectfully disagree that mandating specific provider and supplier types as well as specific categories of practitioners in these requirements is necessary or appropriate. We are finalizing these requirements as 482.43(a). Response: We appreciate the commenter's suggestions related to discharge plan updates and the rechecking of patient goals and preferences. Another commenter supported the proposed requirement and noted that the needs of patients with dementia and their caregivers evolve frequently. Clarify expectations for how providers will address situations where a support person or caregiver is uncooperative, and how hospitals and CAHs should document the involvement of the caregiver and support person. Lastly, the provisions of the IMPACT Act apply to certain PAC providers only, including HHAs, SNFs, IRFs, and LTCHs. Payment for hospital inpatient services for Medicare beneficiaries is paid primarily according to Medicare severity diagnosis-related groups (MS-DRGs), and MS-DRGs for hospital procedures are periodically revised to reflect the latest estimates of costs from hospitals themselves, as well as from other sources. This would have added immensely to the complexity and cost of the discharge planning process. We are redesignating the proposed requirement in 485.642(d)(3) as 485.642(b) and we are eliminating the specific timeframe requirements. We proposed that hospitals consider the availability of, and access to, non-health care services for patients. Medicare Conditions of Participation 2022. We also believe the discharge planning requirements in this final rule are beneficial to patients and their caregivers (where applicable) and will reduce patient readmission risks and improve patient care. This Discharge Planning final rule sets out the obligations of the HHA to both provide information to patients for selecting additional post-acute care services, and to provide important patient care-related information to follow-up care providers. The data that are provided should be pertinent to the patient's goals of care and treatment preferences. The commenter noted that the goals of the regulations should instead be focused on holding providers responsible for outcomes and not the processes of care. Final Decision: After consideration of the comments received, we are requiring implementation of the final requirements for HHAs 60 days after date of publication of this final rule, including the IMPACT Act requirements at 484.58(a). We proposed that patients have the right to access their medical records, upon an oral or written request, in the form and format requested by such patients, if it is readily producible in such form and format (including in an electronic form or format when such medical records are maintained electronically); or, if not, in a readable hard copy form or such other form and format as agreed to by the facility and the patient, including current medical records, within a reasonable time frame. CostsAnnualized Monetized Costs of Discharge Planning to Medical Care Providers. We also proposed to implement the discharge planning requirements of the Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act) (Pub. Therefore, we are not required to estimate the public reporting burden for information collection requirements for these specific elements of the final rule in accordance with chapter 35, title 45 of the United States Code. Although CAHs are not required to include in the discharge plan a list of HHAs, SNFs, IRFs, or LTCHs, there is nothing prohibiting them from doing so. o Have a confidential clinical record/ HIPAA. Commenters stated that these requirements will take time to compile, delaying the ability to summarize pertinent succinct information timely. Some commenters noted that their state did not have a PDMP. 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. The commenter stated that there are a limited number of PAC providers that treat this population. A few commenters questioned whether patient choice would be influenced by the patient receiving services or care from a Medicare fee-for-service provider who may be participating in an alternative payment model, such as bundled payment programs, shared savings programs, or full clinical and financial risk payment programs. or direct patient care roles. In this final rule, we are eliminating the specific timeframe requirements proposed in this section and revising the requirements for hospitals and CAHs to send information to the practitioner(s) responsible for follow-up care prior to the patient's first follow-up visit with the practitioner(s). We also agree that the proposed requirement could potentially have the unintended consequence of shifting hospital resources away from those patients most in need of a discharge plan. PART 482CONDITIONS OF PARTICIPATION FOR HOSPITALS Authority: 42 U.S.C. Comment: Several commenters requested clarification on whether the proposed requirements would apply to certain provider types or programs that are not mentioned in the proposed rule. We expect hospitals and CAHs to include the patient and the patient's caregiver/support person, where applicable, in the planning for a patient's post-discharge care. (18 million patients .1 affected HHAs = 1,800,000 patients in affected HHAs), (1,800,000 patients in affected HHAs .1 discharged or transferred patients who require additional documentation = 180,000 patients). Other commenters noted that HHAs do not prescribe controlled substances or other types of medications. Response: Section 1899B(i) of the Act requires that PAC providers, hospitals and CAHs take into account quality, resource use, and other measures in the Start Printed Page 51845discharge planning process. A number of commenters stated that they already routinely screen certain categories of outpatients, such as observation patients, and that automatically requiring discharge plans for patients in these categories would shift resources away from those patients most in need of discharge plan. Therefore, these discharge planning requirements apply to inpatient psychiatric units located within a hospital or a CAH. Thus, we believe that hospitals are already following most of these requirements and therefore we will not be assessing any additional burden for this section beyond our estimates of the one-time cost to hospitals to modify their policies and procedures in order to ensure that they are meeting the requirements of this rule. The commenter suggested that we require referring facilities to note on their discharge provider list that CAH swing beds are not required to report data similar to freestanding SNFs. Commenters recommended that CMS engage pertinent stakeholders early in an open and transparent process for developing the interpretive guidance, surveyor training, and provider education, and also implement a lean process improvement strategy. In the estimates that follow in this section of the preamble and in the Regulatory Impact Analysis (RIA), we estimate hourly costs. At 485.642(d)(2) we proposed that instructions on post-discharge care include, but not be limited to, instruction on post-discharge care, including instruction on durable medical equipment, if applicable, to be used by the patient or the caregiver/support person(s) in the patient's home, as identified in the discharge plan. Redesignating the requirements in proposed 482.43(c)(10) as 482.43(a)(7), which would still require hospitals to assess their discharge planning processes on a regular basis, which would include ongoing, periodic review of a representative sample of discharge plans, including those patients who were readmitted within 30 days of a previous admission, to ensure that the plans are responsive to patient post-discharge needs. Comment: A commenter stated that if a patient went from an HHA to a SNF there should be an independent review to see if the HHA did everything possible to prevent this outcome, including interviewing the patient. corresponding official PDF file on govinfo.gov. The regulation will require rural providers to assist patients and their families, or their caregivers/support person in selecting a PAC by using and sharing data. Contact information for the practitioner responsible for the care of the patient as described at paragraph (b)(4) of this section and the patient's caregiver/support person(s); All known allergies; including medication allergies; Unique device identifier(s) for a patient's implantable device (s), if any; All special instructions or precautions for ongoing care; as appropriate; All other necessary information, and documentation as applicable, including a copy of the patient's discharge instructions, the discharge summary, and such information and documentation pertaining to current diagnoses, course of illness/treatment, laboratory results, procedures, functional status, and the patient's goals of care and treatment preferences, to ensure a safe and effective transition of care that supports the post-discharge goals for the patient. Comment: One commenter asked that CMS clarify the protocols that providers would be expected to follow if a patient refused to agree to be discharged to a PAC facility chosen on the basis of the supplied quality data and/or family preferences, especially when no other safe options existed in the area. As we note above, we plan to issue further sub-regulatory guidance that will discuss the circumstances of when a discharge summary or transfer summary would be expected at the time of discharge (and transfer if applicable). Standards in the Data Element Library (https://del.cms.gov/) can be referenced on the CMS website and in the ONC Interoperability Standards Advisory (ISA). Comment: Several commenters were concerned that durable medical equipment (DME) requirements were not specifically required in the discharge planning proposed rule. 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. We are not aware of reliable empirical data on the benefits of improved discharge planning. We agree that this issue warrants further study and a better developed evidence base before we proceed further with rulemaking. Lawyer and physician time will also be used. Response: We continue to believe that most hospitals and CAHs have discharge planning processes in place and that these providers will be well prepared to implement the final discharge planning requirements. On November 3, 2015, we published a proposed rule that would update the discharge planning requirements for hospitals, critical access hospitals (CAHs), and post-acute care (PAC) settings (80 FR 68126). Of particular importance for this final rule, the public comments were exceptionally useful in identifying weak or unjustified provisions in the proposed rule as well as in identifying alternatives. (i) This list must only be presented to patients for whom home health care post-hospital extended care services, SNF, IRF, or LTCH services are indicated and appropriate as determined by the discharge planning evaluation. The commenters gave specific examples of instances where patients may leave against medical advice, may be undocumented and not as forthcoming about information, or patients who may be embarrassed about needing social services. We believe that the CAH would establish more specific time frames for completing the evaluation and discharge plans based on the needs of their patients and their own operations. These commenters were concerned that patients may receive inaccurate or outdated information. ), the Office of Information and Regulatory Affairs designated this rule as a major rule, as defined by 5 U.S.C. Therefore, we are not finalizing the proposed requirement to update the discharge plan each time the patient assessment is updated in accordance with the requirements of 484.55(d). Section 2 of the IMPACT Act added section 1899B to the Social Security Act (the Act). 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. Furthermore, the CAH would have to ensure that the PAC data on quality measures and data on resource use measures is relevant and applicable to the patient's goals of care and treatment preferences. These alternatives are discussed throughout the preamble. 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. Response: As part of the medication reconciliation process, in the proposed rule we encouraged practitioners to consult with their state's PDMPs. To meet both the requirements to assist patients in selecting follow-up post-acute care providers and to develop a discharge or transfer summary for each patient, we estimate that it will take an HHA approximately 10 minutes (0.167 hours) per patient. We believe that these final requirements will empower patients to be active participants in the discharge planning process and will help them to make informed choices about their care, which will lead to more competition, lower costs, and improved quality of care. 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. In response to the commenter that requested a definition of caregiver, we note that we often use the terms caregiver, caregiver/support person, and family and/or caregiver, interchangeably, with the same intended meaning. (1) Any discharge planning evaluation must be made on a timely basis to ensure that appropriate arrangements for post-hospital care will be made before discharge and to avoid unnecessary delays in discharge. The authority citation for part 482 is revised to read as follows: Authority: That process involves a review of the organizational structure and policies as well as an interview with the head of medical records. Another commenter suggested that the proposed language be modified to allow physician discretion as to their involvement in the discharge planning process. This proposed revision to the hospital Patients' Rights CoP directly addressed the issues of communication between providers and patients and patient access to their medical records. Response: We are sensitive to the concerns expressed by commenters, as we share their goal of streamlining the regulations to balance the need for minimum health and safety requirements with the need for maximum hospital flexibility to achieve patient outcomes. Response: We appreciate the support for the proposed regulations. Comment: One commenter requested that the interpretive guidance not impose a burdensome documentation requirement for hospitals when conducting the re-evaluation of a patient's discharge needs. 21st Century Nanotechnology Research and Development Act of 2003. Using the wage information from the BLS for medical and health service managers (Code 11-9111), we estimate that the cost of reviewing this rule is $107 per hour, including overhead and fringe benefits https://www.bls.gov/oes/2017/may/oes_nat.htm. Prescriptions for medications that would be required after discharge, including the name, indication, and dosage of each drug along with any significant risks and side effects of each drug as appropriate to the patient. Given that this process is patient-driven, it eliminates the risk of hospital bias in the patient's selection of one of these PAC providers. 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.
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