Medicare and Medicaid Programs; Revisions to Requirements for Discharge Planning for Hospitals, Critical Access Hospitals, and Home Health Agencies, and Hospital and Critical Access Hospital Changes to Promote Innovation, Flexibility, and Improvement in Patient Care

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 482, 484, and 485

[CMS-3317-F and CMS-3295-F]

RIN 0938-AS59

Medicare and Medicaid Programs; Revisions to Requirements for Discharge Planning for Hospitals, Critical Access Hospitals, and Home Health Agencies, and Hospital and Critical Access Hospital Changes to Promote Innovation, Flexibility, and Improvement in Patient Care

AGENCY:

Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION:

Final rule.

SUMMARY:

This final rule empowers patients to be active participants in the discharge planning process and complements efforts around interoperability that focus on the seamless exchange of patient information between health care settings by revising the discharge planning requirements that Hospitals (including Short-Term Acute-Care Hospitals, Long-Term Care Hospitals (LTCHs), Rehabilitation Hospitals, Psychiatric Hospitals, Children's Hospitals, and Cancer Hospitals), Critical Access Hospitals (CAHs), and Home Health Agencies (HHAs) must meet in order to participate in the Medicare and Medicaid programs. This final rule also implements discharge planning requirements which 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, which may ultimately reduce their chances of being re-hospitalized. It also updates one provision regarding patient rights in hospitals, intended to promote innovation and flexibility and to improve patient care.

DATES:

These regulations are effective on November 29, 2019.

FOR FURTHER INFORMATION CONTACT:

Alpha-Banu Wilson, (410) 786-8687, Kianna Banks, (410) 786-3498, CAPT Scott Cooper, USPHS, (410) 786-9465, Eric Laib (410) 786-9759, and Danielle Shearer, (410) 786-6617.

SUPPLEMENTARY INFORMATION:

Inspection of Public Comments:

All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received:

http://www.regulations.gov.

Follow the search instructions on that website to view public comments.

Table of Contents

I. Background

A. Overview

B. IMPACT Act

II. Provisions of the Proposed Regulations and Responses to Public Comments

A. General Comments

B. Discharge Planning Requirements of the IMPACT Act of 2014 (Proposed § 482.43(c)(8), Proposed § 484.58(a)(6), and Proposed § 485.642(c)(8))

C. Implementation

D. Prescription Drug Monitoring Programs (PDMPs)

E. Patients' Rights and Discharge Planning in Hospitals

1. Patient's Access to Medical Records (Proposed § 482.13(d)(2))

2. Conditions of Participation (CoP)—Discharge Planning (Proposed § 482.43)

3. Design (Proposed § 482.43(a))

4. Applicability (Proposed § 482.43(b))

5. Discharge Planning Process (Proposed § 482.43(c))

6. Discharge to Home (Proposed § 482.43(d))

7. Transfer of Patients to Another Health Care Facility (Proposed § 482.43(e))

8. Requirements for Post-Acute Care (PAC) Services (Proposed § 482.43(f))

F. Home Health Agency Discharge Planning (Proposed § 484.58)

1. Discharge Planning Process (Proposed § 484.58(a))

2. Discharge or Transfer Summary Content (Proposed § 484.58(b))

G. Critical Access Hospital Discharge Planning (Proposed § 485.642)

1. Design (Proposed § 485.642(a))

2. Applicability (Proposed § 485.642(b))

3. Discharge Planning Process (Proposed § 485.642(c))

4. Discharge to Home (Proposed § 485.642(d)(1) through (3))

5. Transfer of Patients to Another Health Care Facility (Proposed § 485.642(e))

III. Provisions of the Final Regulations

IV. Collection of Information Requirements

A. ICRs Regarding Hospital Discharge Planning (§ 482.43)

B. ICRs Regarding Home Health Discharge Planning (§ 484.58)

C. ICRs Regarding Critical Access Hospital Discharge Planning (§ 485.642)

V. Regulatory Impact Analysis

A. Statement of Need

B. Overall Impact

C. Anticipated Effects

D. Alternatives Considered

E. Cost to the Federal Government

F. Accounting Statement

G. Regulatory Reform Analysis Under Executive Order 13771

H. Congressional Review Act

I. Background

A. Overview

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). Discharge planning is an important component of a successful transition from hospitals and PAC settings. The transition may be to a patient's home (with or without PAC services), skilled nursing facility (SNF), nursing facility (NF), long term care hospital (LTCH), rehabilitation hospital or unit, assisted living center, substance abuse treatment program, hospice, or a variety of other settings. While Medicare regulations define “post-acute care” providers to include SNFs, LTCHs, inpatient rehabilitation facilities (IRFs) and home health agencies (HHAs), it should be noted that there are other services that can be provided by entities other than PAC providers (that is, LTCHs, IRFs, HHAs, and SNFs), including assisted living facilities, home and community-based services, or primary care providers. 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 also proposed to implement the discharge planning requirements of the Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act) (Pub. L. 113-185), that requires hospitals, including, but not limited to, short-term acute care hospitals, CAHs and PAC providers (LTCHs, IRFs, HHAs, and SNFs), to take into account quality measures and resource use measures to assist patients and their families during the discharge planning process in order to encourage patients and their families to become active participants in the planning of their transition to the PAC or other settings (or between such settings).

We published another proposed rule on June 16, 2016 in the

Federal Register

, titled “Medicare and Medicaid Programs; Hospital and Critical Access Hospital (CAH) Changes to Promote Innovation, Flexibility, and Improvement in Patient Care” (81 FR 39448), hereinafter referred to as the “Hospital Innovation proposed rule”, that proposed to update a number of Conditions of Participation (CoP) requirements that hospitals and CAHs must meet in order to participate in the Medicare and Medicaid programs. One of the proposed hospital CoP revisions in that rule directly addresses the issues

of communication between providers and patients and patient access to their medical records. 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. The hospital could not frustrate the legitimate efforts of patients to gain access to their own medical records and would have to actively seek to meet these requests as quickly as its record keeping system permitted.

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. We are also finalizing the requirements of the IMPACT Act for hospitals, HHAs, and CAHs. 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 may lead to more competition, lower costs, and improved quality of care. 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. Patients and their families who are well informed of their choices of high-quality PAC providers may reduce their chances of being re-hospitalized.

We also believe these final requirements will complement efforts around interoperability that focus on the seamless exchange of patient information between health care settings. 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, medical professional, or caregiver, as applicable.

B. IMPACT Act

The IMPACT Act requires the standardization of PAC assessment data that can be evaluated and compared across PAC provider settings, and used by hospitals, CAHs, and PAC providers, to facilitate coordinated care and improved Medicare beneficiary outcomes. Section 2 of the IMPACT Act added section 1899B to the Social Security Act (the Act). Section 1899B of the Act states that the Secretary of the Department of Health and Human Services (the Secretary) must require PAC providers (that is, HHAs, SNFs, IRFs, and LTCHs) to report standardized patient assessment data, data on quality measures, and data on resource use and other measures. Under section 1899B(a)(1)(B) of the Act, patient assessment data must be standardized and interoperable to allow for the exchange of data among PAC providers and other Medicare participating providers or suppliers. Section 1899B(a)(1)(C) of the Act requires the modification of existing PAC assessment instruments to allow for the submission of standardized patient assessment data to enable comparison of this assessment data across providers. The IMPACT Act requires that assessment instruments be modified to utilize the standardized data required under section 1899B(b)(1)(A) of the Act, no later than October 1, 2018 for SNFs, IRFs, and LTCHs and no later than January 1, 2019 for HHAs. 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. We note that many of these PAC provisions are being addressed in separate rulemakings. More information can be found on the CMS website at:

https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-of-2014-Data-Standardization-and-Cross-Setting-Measures.html.

Section 1899B(j) of the Act requires that we allow for stakeholder input, such as through town hall meetings, open door forums, and mailbox submissions, before the initial rulemaking process to implement section 1899B of the Act. To meet this requirement, we provided the following opportunities for stakeholder input: (1) On February 3, 2015 we convened a technical expert panel (TEP) to gather input on three cross-setting measures identified as potential measures to the requirements of the IMPACT Act, that included stakeholder experts and patient representatives; (2) provided two separate listening sessions on February 10 and March 24, 2015 on the implementation of the IMPACT Act, which also gave the public the opportunity to give CMS input on their current use of patient goals, preferences, and health assessment information in assuring high quality, person-centered and coordinated care enabling long-term, high quality outcomes; (3) in January 2015 we implemented a public mail box for the submission of comments located at

PACQualityInitiative@cms.hhs.gov.

The CMS public mailbox can be accessed on our PAC quality initiatives website:

https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/Submit-a-Question-or-Feedback.html;

(4) held a National Stakeholder Special Open Door Forum on February 25, 2015 to seek input on the measures; and (5) sought public input during the February 2015 ad hoc Measure Applications Partnership (MAP) process meeting regarding the measures under consideration with respect to the IMPACT Act domains. Section 1899B(i) of the Act, which addresses discharge planning, requires the modification of the CoPs, and subsequent interpretive guidance applicable to PAC providers, hospitals, and CAHs at least every 5 years, beginning no later than January 1, 2016. These regulations must require that PAC providers, hospitals, and CAHs take into account quality, resource use, and other measures under subsections (c) and (d) of section 1899B of the Act in the discharge planning process.

We proposed to implement the discharge planning requirements mandated in section 1899B(i) of the Act by modifying the discharge planning or discharge summary CoPs for hospitals, CAHs and HHAs. As stated above, the IMPACT Act added section 1899B to the Act. The IMPACT Act identifies LTCHs and IRFs as PAC providers, but the hospital CoPs also apply to LTCHs and IRFs since these facilities, along with short-term acute care hospitals (including their Inpatient Prospective Payment System (IPPS), excluded rehabilitation or psychiatric units), rehabilitation hospitals, psychiatric hospitals, children's hospitals, and cancer hospitals) are all classifications of hospitals. All classifications of hospitals (as well as distinct part

psychiatric and rehabilitation units in CAHs) are subject to most of the same core hospital CoPs. Therefore, these PAC providers (including freestanding LTCHs and IRFs) are also subject to the revisions to the hospital CoPs. We finalized the discharge planning requirements for SNFs and NFs in a final rule published on October 4, 2016 in the

Federal Register

, titled “Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities” (81 FR 68688). The various providers' compliance with these requirements is assessed through on-site surveys by CMS, State Survey Agencies (SAs) or national accrediting organizations (AOs) that have CMS-approved Medicare accreditation programs.

II. Provisions of the Proposed Regulations and Responses to Public Comments

On November 3, 2015, we published a proposed rule in the

Federal Register

, titled “Revisions to Requirements for Discharge Planning for Hospitals, Critical Access Hospitals, and Home Health Agencies” (80 FR 68126), hereinafter referred to as the “Discharge Planning proposed rule,” that would revise the discharge planning requirements that hospitals (including, but not limited to, LTCHs and IRFs), CAHs, and HHAs must meet in order to participate in the Medicare and Medicaid programs. In addition, we proposed to implement the discharge planning requirements of the IMPACT Act. In response to the proposed rule, we received 299 public comments. Commenters included individuals, health care professionals and corporations, national associations and coalitions, state health departments, patient advocacy organizations, and individual facilities that will be impacted by the rule. Generally, most comments centered on the hospital requirements, but could be applied to all provider types included in the proposed rule. We also received various comments in response to our solicitation for comments related to specific proposals.

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. 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. Therefore, we are finalizing a patients' right provision at 42 CFR 482.13 that we proposed in the Hospital Innovation proposed rule. The provision we are finalizing here ensures a patient's right to access his or her own medical information from a hospital. This is the only provision of that rule that we are finalizing in this final rule. We are continuing to consider comments on the remaining portion of the Hospital Innovation proposed rule, and we will respond to those comments when we finalize that rule in future rulemaking.

In this final rule, we provide a summary of our proposed provisions, a summary of the public comments received and our responses to them, and the policies we are finalizing for hospitals, HHAs, and CAHs. We have organized our proposed provisions and responses to the comments as follows: General comments; Discharge Planning Requirements of the IMPACT Act of 2014; Implementation; Prescription Drug Monitoring Programs; Patients' Rights and Discharge Planning in Hospitals; Home Health Agency Discharge Planning; and Critical Access Hospital Discharge Planning. Except for comments specific to the Hospital Innovation proposed rule, all comments discussed here were submitted in response to the Discharge Planning proposed rule. Comments related to the paperwork burden and impact analysis sections are addressed in section VI, “Regulatory Impact Analysis” of this final rule.

A. General Comments

We received comments suggesting improvements to our regulatory approach or requesting clarification on general issues related to our proposed discharge planning requirements. The comments and our responses to those general comments are as follows.

Comment:

The majority of commenters generally supported standardizing and modernizing the discharge planning requirements for hospitals, including LTCHs and IRFs, HHAs, and CAHs. Individuals, including former patients, health care professionals, and advocacy groups strongly supported more stringent, detailed discharge planning requirements that focus on person-centered care and on the patient's treatment preferences and goals of care. Some of these commenters noted that without these requirements, some discharges from hospitals have been unsafe or inadequate and have led to readmissions or unnecessary emergency department visits shortly after discharge.

However, most commenters disagreed with certain, specific proposed discharge planning requirements. Many of these commenters stated that the requirements were too burdensome or overly prescriptive. Some of these commenters found that the proposed requirements did not go far enough to protect patients. Finally, a few commenters were against new discharge planning requirements altogether.

Response:

We believe that these final discharge planning requirements for hospitals, including LTCHs, IRFs, HHAs, and CAHs will improve transitions of care, increase a patient's ability to access their health care information in a timely manner, and complement and align with efforts to improve interoperability across the care continuum. We also believe that these final requirements, which we discuss in further detail in subsequent sections of this final rule, are less burdensome than our initial proposed discharge planning requirements. In addition, we continue to believe in the importance of person-centered care during the discharge planning process. Person-centered care focuses on the patient as the locus of control, supported in making their own choices and having control over their daily lives.

These final requirements will establish and standardize discharge planning requirements for hospitals, HHAs, and CAHs. We note that effective discharge planning can also help to reduce patient readmissions, improve patient quality of care and outcomes, and reduce avoidable complications, adverse events, and readmissions.

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 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.

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. A few commenters questioned whether the proposed discharge planning requirements would apply to inpatient psychiatric facilities, and one commenter asked whether the rule would apply to inpatient psychiatric units. The commenter recommended that CMS explicitly state which

provider types would be required to comply with the discharge planning CoPs. One commenter requested clarification as to whether the proposed requirements would apply to partial hospitalization and intensive outpatient programs at hospitals.

Response:

All classifications of hospitals except CAHs are regulated under part 482 of our regulations, and are subject to the same set of hospital CoPs. We further clarified that the PAC providers mentioned in the IMPACT Act, specifically LTCHs and IRFs, would also be subject to the proposed revision to the hospital CoPs. We did not list all the classifications of hospitals in the proposed rule since we specifically focused on the PAC providers mentioned in the IMPACT Act, but we understand the importance of delineating which hospital types would have to comply with the hospital discharge planning CoPs, since they were not explicitly mentioned in the proposed rule. Therefore, we are clarifying that these final discharge planning requirements apply to all classifications of hospitals, including short-term acute care hospitals (including their IPPS-excluded rehabilitation or psychiatric units), psychiatric hospitals, LTCHs, rehabilitation hospitals, children's hospitals, and cancer hospitals. Throughout this final rule, we clarify that where the term “hospital” is used, we are referring to the aforementioned hospital classifications. These requirements would also apply to distinct part psychiatric and rehabilitation units in CAHs.

Although these discharge planning requirements apply to psychiatric hospitals, there are several additional currently existing discharge planning requirements specific to psychiatric hospitals that are not affected by the discharge planning requirements discussed in this rule. Thus, psychiatric hospitals will still be required to meet the additional special provisions, special medical record requirements, and special staff requirements set out at §§ 482.60, 482.61, and 482.62.

Inpatient psychiatric units located in a hospital, (as opposed to psychiatric hospitals) are specialized units within a larger hospital or CAH. Inpatient psychiatric units must meet the hospital CoP requirements for the hospitals in which they are located. However, they are not required to meet the CoPs specific to psychiatric hospitals set out at §§ 482.60, 482.61, and 482.62. Therefore, these discharge planning requirements apply to inpatient psychiatric units located within a hospital or a CAH. The additional, currently existing, discharge planning requirements for psychiatric hospitals do not apply to inpatient psychiatric units. Note that “inpatient psychiatric facility” is a CMS classification used to refer to both psychiatric hospitals and inpatient psychiatric excluded units of hospitals and inpatient psychiatric distinct part units of CAHs; however, psychiatric excluded and distinct part units in hospitals and CAHs are not subject to the requirements under §§ 482.60, 482.61, and 482.62.

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. These discharge planning requirements however would not apply to services provided to patients in a community health center.

Comment:

Several commenters were concerned that durable medical equipment (DME) requirements were not specifically required in the discharge planning proposed rule. The commenters explained that providers should address and document a patient's DME needs during the discharge planning process. A few commenters also noted that DME was not addressed in the Meaningful Use Stage 3 requirements (80 FR 62761, which is discussed in our response here), and thus is still largely in paper format.

Response:

We agree that considering a patient's DME needs when planning for a patient's post-hospital care is a best practice. While we are not mandating that providers include information on a patient's DME needs in the patient's discharge instructions at this time, we encourage providers to do so where appropriate. However, comments regarding specific Stage 3 Meaningful Use requirements are not within the purview of these CoPs.

Comment:

One commenter noted the absence of proposed discharge planning requirements for SNFs in the Discharge Planning proposed rule. One commenter requested that CMS require nursing homes to provide patients with prescriptions before the patient returns home or back to the community. 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. 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.

Response:

Comments regarding LTC facilities and Medicaid demonstration programs are outside the scope of this final rule. 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.

Comment:

A few commenters recommended that if CMS finalizes the proposed requirements, the final regulation and sub-regulatory guidance should not focus on the process of discharge planning alone, but allow providers greater flexibility to ensure their efforts are meaningful and adaptable over time. One commenter believed that the proposed rule included too many details on the discharge planning process instead of focusing on outcomes, which the commenter stated, could lead to “performing to the test” activities that inhibit innovation. 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. The commenter noted that CMS already has several programs that focus on outcomes, including value-based payment plans and hospital compare and star rating systems. The commenter ultimately believed that providers should use these mechanisms to drive innovation and lead to the best possible outcomes.

Another commenter expressed concern over the potential impact of the proposed requirements on currently existing state innovation programs aimed at adopting value-based payment. The commenter recommended that CMS review the proposed changes to the CoPs, with support for state flexibility for innovation. Finally, another commenter noted that providers would need support in implementing and understanding the finalized discharge planning requirements.

Response:

We understand the commenters' concerns and have revised most of the proposed requirements in this final rule to focus less on prescriptive and burdensome process details, and more on patient outcomes and treatment preferences through the use of enhanced information exchange and innovative practice standards. We encourage hospitals, HHAs, and CAHs to actively engage with patients to create a more meaningful discharge planning process. We believe these requirements will afford patients the opportunity to

be active participants in the discharge planning process. In addition, in order to encourage patient engagement and understanding of their discharge plan or instructions, we recommend that providers follow the National Standards for Culturally and Linguistically Appropriate Services (CLAS) in Health and Health Care (

https://www.thinkculturalhealth.hhs.gov/clas/standards

), which provide guidance on providing instructions in a culturally and linguistically appropriate manner. 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). In addition, providers are reminded to take appropriate steps to ensure effective communication with individuals with disabilities, including the provision of auxiliary aids and services, in accordance with section 504 of the Rehabilitation Act, the Americans with Disabilities Act, and section 1557 of the Affordable Care Act (see,

http://www.hhs.gov/civil-rights

and

http://www.ada.gov

for more information on these requirements).

We believe that the requirements, as revised here in this final rule, are consistent with the innovation goals of existing programs and initiatives, including the Hospital Value-Based Purchasing Program and the Center for Medicare and Medicaid Innovation's State Innovation Models Initiative.

As with all CoPs, compliance with these requirements will be monitored by CMS, SAs, and AOs through surveys. We understand the commenter's concerns about provider support in implementing and understanding the final discharge planning requirements. We will provide sub-regulatory interpretive guidance after the publication of this final rule, which will provide further clarification for implementing the final discharge planning requirements.

Comment:

A few commenters requested changes to the terminology used throughout the proposed rule while others requested that CMS define certain terms used throughout the rule. One commenter requested that CMS use the term “transition management” instead of discharge planning.

A few commenters recommended that CMS replace the term “patient” with “individual,” “person” or “affected person,” where appropriate, in order to further emphasize the expectation that the discharge planning process should be person-centered.

A few commenters also had suggestions on the definition of “caregiver.” One commenter recommended that the proposed rule define the term “caregiver.” The commenter noted that several terms are used throughout the proposed rule, including “caregiver,” “caregiver/support person,” and “family and/or caregiver.”

Response:

We agree that there are several different types of terminology providers may utilize when referring to some of the concepts used in this rule. 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. In addition, the terminology used throughout this rule is used in the Act, including the term “discharge planning process” as set forth in section 1861(ee) of the Act.

In addition, consistent with the language widely used by providers as well as the language used in the CoPs for hospitals, CAHs and HHAs, we continue the use of the term “patient.” As a result, we do not believe that it is appropriate to exclusively use “person” or “individual.” However, we acknowledge that the use of “person” or “individual” also appropriately refers to a patient, and we have used this terminology at various points in the rule (for example, when referring to person-centered care).

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. We use these various terms in order to be consistent with the regulations that already exist for hospitals, HHAs, and CAHs. We do not believe that it is necessary to define the term, as it does not have a special meaning in this rule.

Comment:

Several comments were submitted related to the responsibilities of hospitals, HHAs, and CAHs to involve and communicate with caregivers. Commenters recommended the following:

• Require hospitals, HHAs, and CAHs to allow patients at least one opportunity to identify at least one caregiver/support person upon admission and prior to discharge or transfer to another facility, and to collect caregiver telephone contact and email address information when the provider offers the patient an opportunity to designate a caregiver.

• Clarify that providers must make reasonable attempts to contact the patient's identified caregiver during the discharge planning process.

• 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.

• Require providers to ask what the preferred method of contact is for the caregiver.

• Require the provider to document all attempted contact with the caregiver.

• Clarify that caregivers and support persons should be involved, as applicable, but that CMS is not expecting that all patients will have caregivers and support persons and that the extent of the involvement of patients and caregivers be consistent with the patient's wishes and applicable law, including with the HIPAA Privacy Rule.

• 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.

• 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.

• Provide caregivers with the name and contact information for the staff in the hospital or CAH, with whom they can discuss any concerns about the discharge plan or changes in the patient's care.

• Require providers to give the caregiver a copy of the final discharge plan, since “informed of the final plan” is not defined.

Response:

We appreciate the commenter's concerns regarding the inclusion of the patient's caregiver during the discharge planning process. We continue to strongly believe that a patient's caregiver should be included in the discharge planning process, and have revised the regulations at § 482.43 for hospitals and § 485.642 for CAHs to allow more flexibility for hospitals and CAHs in how such inclusion is achieved. We agree that we would not expect each patient to have a caregiver or support person, and that any level of caregiver involvement would be consistent with § 164.510(b) of the HIPAA Privacy Rule as well as all other pertinent federal and state laws. 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. While it is beneficial for providers to obtain the contact information for a patient's designated caregiver, we disagree with the commenter's recommendation to mandate such a

requirement and believe that it would not be appropriate to require providers to make multiple attempts to contact caregivers during the discharge planning process. Such a requirement could prove to be burdensome to providers who are already compiling information for a discharge plan or discharge instructions and could potentially have the effect of hindering the discharge planning process. In addition, we do not believe that we should require hospitals to provide caregivers with the name and contact information for the staff at the hospital or CAH, as this may change over time. However, we note that as a best practice hospitals should give caregivers pertinent hospital contact information, so that caregiver can easily discuss concerns about the patient's discharge plan or instructions.

While we are not requiring providers to give a copy of the discharge plan to caregivers, patients can request a copy of their medical record, including the discharge plan, from the hospital, in their requested form and format, as required by newly revised § 482.13(d)(2) (as discussed below), and the hospital must comply with the patient's access request as required by the HIPAA Privacy Rule at 45 CFR 164.524. Similar requirements exist for HHAs and CAHs as well.

Comment:

Several commenters submitted specific comments about the sub-regulatory interpretive guidance. 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.

Response:

As with all regulations regarding the CoPs, the interpretive guidance will be updated once this final rule is published. The development of the interpretive guidance is a sub-regulatory process and is not required to be circulated for public comment. Comments regarding the process for developing the interpretive guidance and state survey and certification procedures are outside the scope of this final rule.

Comment:

One commenter requested an extension to the 60-day comment period. Another commenter stated that the comment period was adequate.

Response:

We believe that the 60-day comment period was sufficient, as evidenced by the number of comments we received. The comment period closed on January 4, 2016 for the Discharge Planning proposed rule, and on August 15, 2016 for the Hospital Innovation proposed rule.

Comment:

A few commenters asked for clarification regarding provider reimbursement.

Response:

Comments related to provider reimbursement are outside the scope of this final rule.

Comment:

One commenter recommended that a patient's written notice of beneficiary's rights as an inpatient include a description of the patient's discharge rights. They also recommended that providers be required to provide patients with a discharge planning fact sheet. Another commenter recommended adding an additional section for hospitals, HHAs, and CAHs that would require these providers to advise patients of their rights to appeal a discharge or complain about the quality of care and advise the patient of the availability of assistance from Beneficiary and Family Centered Care Organizations. The commenters suggested referring to several CMS links regarding hospital appeals.

Response:

The policies regarding a beneficiary's rights as an inpatient are outside the scope of this final rule. We continue to require providers to include patients and their caregiver/support persons in the discharge planning process. 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. Outside of the CoPs, other specific CMS requirements regarding the Medicare beneficiary appeals process may apply.

Comment:

We received a large number of similar comments from individuals regarding patient nutrition and food security needs. Commenters recommended that the discharge planning requirements include a nutritional component and that specific language regarding food and nutritional services during the discharge planning process be included in the regulations.

Response:

While we agree that a patient's nutrition and food security needs may impact care after discharge, we do not agree that including specific language regarding food and nutritional services during the discharge planning process is necessary for all patients as a minimum discharge planning requirement. We believe that mandating such additional requirements would be burdensome. However, we encourage providers to consider and address any patient food and drug interactions, as well as the patient's nutritional needs, as part of the necessary medical information that must go along with the patient as part of the discharge plan and which we are finalizing in this rule.

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). Some commenters focused on the development of a modular certification program for long-term and PAC providers, who were not eligible for meaningful use incentives under Medicare or Medicaid as authorized by the Health Information Technology for Economic and Clinical Health Act (HITECH Act). Additionally, commenters urged CMS and ONC to consider ways to encourage the adoption and use of these tools by rural and frontier providers to prevent a digital gap.

Another commenter recommended that the requirements in this rule align with current health IT certification requirements, in order to eliminate redundancy.

One commenter suggested that CMS require facilities that are electronically capturing information to do so using certified health IT.

Response:

We did not propose the required use of certified health IT for health care providers under the CoPs. We also did not propose that providers use a specific form, format, or methodology for the communication of patient health care information. Therefore, these comments are out of scope of this rule. However, we strongly believe that those facilities that are electronically capturing information should be doing so using certified health IT that will enable real time electronic exchange with the receiving provider and with patients. We also believe that health IT should be interoperable and that by using certified health IT, facilities can ensure that they are transmitting interoperable data that can be used by other settings, supporting a more robust care coordination and higher quality of care for patients. 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.

CMS is firmly committed to the use of certified health IT and interoperable EHR systems for electronic healthcare information exchange to effectively help hospitals and other Medicare- and Medicaid-participating providers and suppliers improve internal care delivery practices, support the exchange of important information across care team members during transitions of care, and enable reporting of electronically

specified clinical quality measures (eCQMs). 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. The DEL furthers CMS' goal of data standardization and interoperability, which is also a goal of the IMPACT Act. These interoperable data elements can reduce provider burden by allowing the use and exchange of healthcare data, support provider exchange of electronic health information for care coordination, person-centered care, and support real-time, data driven, clinical decision making. 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). The 2019 Interoperability Standards Advisory (ISA) is available at

https://protect2.fireeye.com/url?k=44af3763-18fa3e70-44af065c-0cc47adb5650-601d6acb74373f82&u=https://www.healthit.gov/isa.

We note that we work in conjunction with the Office of the National Coordinator for Health Information Technology (ONC), which acts as the principal federal entity charged with coordination of nationwide efforts to implement and use health information technology and the electronic exchange of health information on behalf of HHS, to promote these goals. As previously noted, ONC finalized the 2015 Edition final rule, which sets out the current criteria for health IT to be certified under the ONC Health IT Certification Program. The 2015 Edition final rule facilitates greater interoperability for several clinical health information purposes and enables health information exchange through new and enhanced certification criteria, standards, and implementation specifications. We note that CMS requires eligible hospitals and CAHs in the Medicare and Medicaid Promoting Interoperability Programs (previously known as the EHR Incentive Programs) and eligible clinicians in the Quality Payment Program (QPP) to use EHR technology certified to 2015 Edition health IT certification criteria beginning in CY 2019 (42 CFR 414.1305, 495.4, (81 FR 77538, 77555)). The 2015 Edition also defines a core set of data that health care providers have noted is critical to interoperable exchange and can be exchanged across a wide variety of other settings and use cases, known as the Common Clinical Data Set (C-CDS) (80 FR 62608 through 62702).

In an effort to continue to support seamless and secure access, exchange, and use of electronic health information, ONC published a proposed rule on March 4, 2019 in the

Federal Register

, titled “21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program” (84 FR 7424), which would implement certain provisions of the 21st Century Cures Act (the Cures Act) (Pub. L. 114-255), including conditions and maintenance of certification requirements for health information technology (health IT) developers under the ONC Health IT Certification Program (Program), the voluntary certification of health IT for use by pediatric health care providers, and reasonable and necessary activities that do not constitute information blocking.

The proposed rule would also modify the 2015 Edition health IT certification criteria and Program in additional ways to advance interoperability, enhance health IT certification, and reduce burden and costs. Specifically, the proposed rule builds on the Common Clinical Data Set with the U.S. Core Data for Interoperability (Version 1) (USCDI). The USCDI aims to support the goals set forth in the Cures Act by specifying a common set of data classes that will be required for interoperable exchange, and identifying a predictable, transparent, and collaborative process for achieving those goals (

https://www.healthit.gov/isa/us-core-data-interoperability-uscdi

).

Section 4003 of the Cures Act, enacted in 2016, and amending section 3001 of the Public Health Service Act (42 U.S.C. 300jj-11(c)), requires HHS to take steps to advance the electronic exchange of health information and interoperability for participating providers and suppliers in various settings across the care continuum. Specifically, Congress directed that ONC “. . . for the purpose of ensuring full network-to-network exchange of health information, convene public-private and public-public partnerships to build consensus and develop or support a trusted exchange framework, including a common agreement among health information networks nationally.” A trusted exchange framework can allow for the secure exchange of electronic health information with, and use of electronic health information from other health IT without special effort on the part of the user. Trusted exchange networks allow for broader interoperability beyond one health system or point to point connections among payers, patients, and providers. Such networks establish rules of the road for interoperability, and with maturing technology, such networks are scaling interoperability and gathering momentum with participants, including several federal agencies, EHR vendors, retail pharmacy chains, large provider associations, and others.

In light of the widespread adoption of EHRs, along with the increasing availability of health information exchange infrastructure predominantly among hospitals, we solicited public comments on how we could use the CMS health and safety standards that are required for providers and suppliers participating in the Medicare and Medicaid programs (that is, the CoPs, the CfCs, and the requirements for Long Term Care (LTC) Facilities) to further advance electronic exchange of information that supports safe, effective transitions of care between hospitals and community providers in the Request for Information published in our payment rules in 2018 in the

Federal Register

, titled “Request for Information on Promoting Interoperability and Electronic Healthcare Information Exchange through Possible Revisions to the CMS Patient Health and Safety Requirements for Hospitals and Other Medicare- and Medicaid-Participating Providers and Suppliers”. 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.

To fully understand all of these health IT interoperability issues, initiatives, and innovations through the lens of its regulatory authority, we invited members of the public to submit their ideas on how best to accomplish the goal of fully interoperable health IT and EHR systems for Medicare- and Medicaid-participating providers and suppliers, as well as how best to further contribute to and advance the MyHealthEData initiative for patients. We were particularly interested in identifying fundamental barriers to interoperability and health information exchange, including those specific barriers that prevent patients from being

able to access and control their medical records. We also welcomed the public's ideas and innovative thoughts on addressing these barriers and ultimately removing or reducing them in an effective way, and how revisions to the current CMS CoPs, CfCs, and RfPs for hospitals and other participating providers and suppliers could play a role in addressing these barriers. We refer readers to the specific Request for Information sections in the following 2019 payment rules:

• FY 2019 Inpatient Prospective Payment System/Long Term Care Hospital Prospective Payment System Proposed Rule (83 FR 20550 through 20553);

• FY 2019 Inpatient Rehabilitation Facility Prospective Payment System Proposed Rule (83 FR 21004 through 21007);

• FY 2019 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements Proposed Rule (83 FR 20963 through 20966);

• FY 2019 Inpatient Psychiatric Facilities Prospective Payment System and Quality Reporting Updates Proposed Rule (83 FR 21135 through 21138);

• FY 2019 Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities (SNF) Proposed Rule (83 FR 21089 through 21092);

• CY 2019 Home Health Proposed Rule (83 FR 32471 through 32473);

• CY 2019 End-Stage Renal Disease Prospective Payment System Proposed Rule (83 FR 34391 through 34394);

• CY 2019 Physician Fee Schedule Proposed Rule (83 FR 36006 through 36009); and

• CY 2019 Outpatient Prospective Payment System/Ambulatory Surgical Center Proposed Rule (83 FR 37209 through 37211).

We note that the comments we received on this Request for Information will be reviewed for informational purposes as we consider new or revised CoPs/CfCs/requirements for interoperability and electronic exchange of health information in future rulemaking.

Additionally, CMS published a proposed rule, which, if finalized as proposed, would improve interoperability and outline opportunities to make patient data more useful and transferable through open, secure, standardized, and machine-readable formats while reducing restrictive burdens on healthcare providers (84 FR 7610). Specifically, the proposed rule would revise the CoPs by requiring a hospital, psychiatric hospital, or CAH, which utilizes an EHR system with the capacity to generate information for patient event notifications (based on admission, discharge, and transfer (ADT) messages,) to demonstrate that its system's notification capacity is fully operational, is operating in accordance with all state and federal statutes and regulations regarding the exchange of patient health information, and utilizes a specified content exchange standard. Such patient event notifications would be required to include defined minimum patient health information, which were proposed to include the minimum patient health information (which must be patient name, treating practitioner name, sending institution name, and, if not prohibited by other applicable law, patient diagnosis). 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. And, in recognition of factors outside of a facility's control that may determine whether or not a notification can be successfully transmitted, an applicable hospital (as well as an applicable psychiatric hospital or CAH) would only be required to send ADT messages to licensed and qualified practitioners, other patient care team members and PAC services providers and suppliers (1) that receive the notification for treatment, care coordination, or quality improvement purposes; (2) that have an established care relationship with the patient relevant to his or her care; and (3) for whom the hospital (or psychiatric hospital or CAH) has a reasonable certainty of receipt of notifications.

Comment:

One commenter stated that we should develop consistent standards of communication, information sharing, and discharge planning across the entire acute and post-acute care continuum. The commenter states that this consistency will facilitate standardization of the information collected and definitions used to improve the process, enhance communication, and ensure everyone is working toward the same goals.

Response:

We agree that standardized methods of communication can be helpful to encourage consistency regarding compliance with this requirement. With regards to EHRs, we note that as of 2015, nearly all (96 percent) of non-federal acute care hospitals reported possessing a certified EHR system. Substantial adoption of certified health IT among hospitals is an important factor in moving the health care system towards common standards for sharing data. (ONC/American Hospital Association (AHA), AHA Annual Survey Information Technology Supplement (

http://dashboard.healthit.gov/evaluations/data-briefs/non-federal-acute-care-hospital-ehr-adoption-2008-2015.php.

). 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.

Aside from the certification of EHR technology that was finalized in other rules, we did not propose standardized methods of communication and information sharing between different health care provider types as part of the Conditions of Participation.

Comment:

A few commenters suggested adding pharmacists and occupational therapists to the discharge planning team. Another commenter suggested that we require hospitals, CAHs, and HHAs to consult with a “conflict-free community care coordinator” in developing the discharge plan and in identifying a list of HHAs, SNFs, IRFs, or LTCHs that are available to provide post-acute care.

Response:

Our use of the broad term “practitioner” encompasses all practitioners, including non-physician practitioners, which may be operating within a hospital. Providers may utilize the appropriate practitioners that they believe will effectively conduct a patient's discharge planning process. For those reasons, the discharge planning CoPs do not include requirements specific to individual practitioner categories. The regulations text, as written, does not explicitly state who must provide the list of PAC providers to the patient or their representative. In addition, the regulation text does not prohibit hospitals from including any qualified personnel it chooses in this part of the discharge planning process. Typically, the list of PAC providers is given to patients or their representative by a social worker or registered nurse (who is a case manager). The hospital must identify in its discharge planning policy the qualified personnel who will be involved in the discharge planning process and must execute their discharge planning process in accordance with their policies.

We appreciate the suggestion that providers utilize a conflict-free advisor. However, we believe that provider staff are capable of complying with the requirement to assist patients and their caregivers in selecting a post-acute care 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. The utilization of contracted entities to perform this service would be a business decision of the provider, and it is not necessary to compel such business relationships via a regulatory requirement.

Comment:

One commenter recommended that the discharge planning regulations be reviewed and updated more frequently.

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.

B. Discharge Planning Requirements of the IMPACT Act of 2014 (Proposed § 482.43(c)(8), Proposed § 484.58(a)(6), and Proposed § 485.642(c)(8))

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. Furthermore, the hospital 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. We would also expect the hospital to document in the medical record that the PAC data on quality measures and resource use measures were shared with the patient and used to assist the patient during the discharge planning process.

We also proposed requirements for HHAs in accordance with the requirements of the IMPACT Act. For those patients who are transferred to another HHA or who are discharged to a SNF, IRF, or LTCH, we proposed at § 484.58(a)(6) to require that the HHA assist patients and their caregivers 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.

As required by the IMPACT Act, HHAs must take into account data on quality measures and resource use measures during the discharge planning process. 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. We received many public comments on these proposed requirements for HHAs and we refer readers to section II.C.4 of this final rule for a summary of those comments and our responses.

Finally, for CAHs, we proposed at § 485.642(c)(8) to require that CAHs assist patients, their families, or their caregiver's/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. We would expect that the CAH would be available to discuss and answer patients and their caregiver's questions about their post-discharge options and needs. We would also expect the CAH to document in the medical record that the PAC data on quality measures and resource use measures were shared with the patient and used to assist the patient during the discharge planning process.

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. As required by the IMPACT Act, CAHs would be required to take into account data on quality measures and data on resource use measures during the discharge planning process. 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. For example, the CAH could provide the aforementioned quality data on PAC providers that are within the patient's desired geographic area. CAHs could also provide quality data on HHAs based on the patient's preference to continue their care upon discharge to home. CAHs should assist patients as they choose a high quality PAC provider. However, we would expect that CAHs would not make decisions on PAC services on behalf of patients and their families and caregivers and instead focus on person-centered care to increase patient participation in post-discharge care decision making.

Comment:

While many commenters supported the IMPACT Act's goals to standardize data amongst PAC providers, most commenters requested clarification on the specifics of the proposed IMPACT Act discharge planning requirements for hospitals, HHAs, and CAHs. Most commenters asked CMS to clarify what data sources hospitals would be expected to use and where these data sources would be available. One commenter recommended that hospitals not assist patients in selecting a PAC provider or making decisions about the patient's post-acute needs, and instead require that access to these data be made available to patients and their families. A few commenters questioned the use of the Nursing Home Compare and Home Health Compare websites. These commenters were concerned that patients may receive inaccurate or outdated information. One of these commenters recommended that CMS provide a publicly available database of certified providers. 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. The commenter further stated that additional studies would need to be conducted on how to disseminate this data in a manner that is easily understood and meets CLAS standards. The commenter therefore recommended that CMS provide standard, publicly-available data visualization and interpretation standards or guides. Additionally, another commenter recommended that CMS develop a patient resource to assist with the interpretation of the quality and resource use data. Another commenter noted that while quality data is available through the Nursing Home and Home Health Compares, similar websites do not exist for other PAC providers, such as IRFs.

Several commenters questioned whether relevant hospital practitioners were qualified to interpret, discuss, and answer questions about the quality and resource use data. 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. In particular, the commenters stated that CMS should provide concise, consumer-friendly information on each measure and how to evaluate the performance of a specific measure to determine whether a certain provider is appropriate for a patient. Another commenter asked that the final rule acknowledge that it may not be feasible for a hospital to provide complex quality data for each PAC facility that is being considered with the expectation that the hospital explain all of the nuances that account for different ratings.

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

discharge planning process. We understand that commenters had concerns about using appropriate data that would be comparable to the data that would be gathered and provided in accordance with the requirements of the IMPACT Act. However we note that since the publication of the proposed rule in 2015, the measures we implemented into the PAC Quality Reporting Program (QRPs) for the domains of functional status, skin integrity, the incidence of major falls, and the resource use and other measures as required by the Act are now publicly available on the IRF, SNF, LTCH, and Home Health (HH) Compare websites. Data from these measures are now being reported to providers by means of private provider feedback reports. Other data as required by the IMPACT Act will be publicly available in the near future. We therefore expect providers to make reasonable efforts to use the quality and resource use measure data that are currently available to them until all of the measures stipulated in the IMPACT Act are finalized and publicly reported. 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:

•

https://www.medicare.gov/inpatientrehabilitationfacilitycompare/.

•

https://www.medicare.gov/homehealthcompare/search.html.

•

https://www.medicare.gov/nursinghomecompare/search.html.

•

https://www.medicare.gov/longtermcarehospitalcompare/.

While the data from these sources are not available in “real time,” the data are posted as soon as feasible. Providers should use these data sources to assist patients as they choose a PAC provider that aligns with the patient's goals of care and treatment preferences, and we would also expect providers to document all efforts regarding this requirement in the patient's medical record.

We believe that providers have the ability and knowledge to interpret and discuss the publicly available data on quality and resource use measures at the most basic levels. We note that we do not expect providers to give overly detailed and complex analyses of the quality and resource use data, which may only serve to confuse patients and/or their caregivers, nor do we expect providers to attempt to provide patients and their caregivers with data that do not exist regarding PAC facilities. We expect providers to put forth their best effort to answer patient questions regarding the data. We also encourage providers to refer to

www.medicare.gov

for additional resources and help. Further information regarding specific measures mandated by the IMPACT Act will be available in forthcoming regulations. Finally, we also encourage providers to consult the sub-regulatory interpretive guidance that will be available after publication of the final rule.

Comment:

Several commenters asked for clarification on what additional information can be provided to patients about PAC providers. A few commenters gave examples of marketing materials, other information the provider may have regarding a PAC's quality and resource use, whether the patient's health insurance covers the patient's specific PAC provider choice, and information regarding out of pocket cost for PAC providers.

Response:

Providers can use additional available information to assist patients as they select a PAC provider, so long as the information presented aligns with the patient's goals of care and treatment preferences. The IMPACT Act in no way limits providers' ability to augment the information provided to patients. All attempts to assist patients should be documented in the medical record.

Furthermore, these discharge planning requirements do not prohibit providers from giving patients information regarding coverage of a selected PAC by the patient's insurance or specifics on out of pocket costs for PAC providers. Providers may give this information to patients if they choose. 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. We do not believe that it is appropriate to mandate such a requirement here, as these CoPs provide basic requirements for the discharge planning process.

Comment:

Several commenters asked for clarification on how providers can assist patients in choosing a PAC provider without improperly steering the patient to certain providers. Some commenters expressed concern that the proposed requirements may lead to hospital steering, with some commenters expressing concern that certain hospitals may employ tactics to purposely channel patients to other providers or suppliers within their medical system or under common ownership. 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.

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.

Response:

We understand the commenter's concerns regarding patient steering. However, we believe compliance with the revised CoP and the fraud and abuse laws, including the physician self-referral law and Federal anti-kickback statute, is achievable. We believe that hospitals, HHAs and CAHs will be in compliance with this requirement if they present objective data on quality and resource use measures specifically applicable to the patient's goals of care and treatment preferences, taking care to include data on all available PAC providers, and allowing patients and/or their caregivers the freedom to select a PAC provider of their choice. Providers will have to document all such interactions in the medical record. In addition, we expect hospitals to comply with the requirements in § 482.43(c) and inform the patient and/or the patient's representative of their freedom to choose among participating Medicare providers and suppliers of post-discharge services, while not specifying or otherwise limiting the qualified providers or suppliers that are available to the patient. Hospitals, HHAs, and CAHs that have concerns that providing objective information in these circumstances may conflict with other laws can obtain guidance on the physician self-referral law at

www.cms.gov/physicianselfreferral

and on the Federal anti-kickback statute at

www.oig.hhs.gov.

Information about obtaining advisory opinions regarding the application of the physician self-referral law in specific circumstances can be found at

https://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/advisory_opinions.html

and regarding the application of the anti-kickback law at

https://oig.hhs.gov/compliance/advisory-opinions/index.asp.

We remind providers that compliance with these requirements will be assessed through on-site surveys by CMS, state survey agencies, and AOs and that purposeful patient steering

(that is, directing patients and/or their caregivers to PAC providers that do not align with the patient's goals of care and treatment preferences) could lead to a determination of provider noncompliance with the requirements in this rule. We also note that physician self-referral violations may result in imposition of penalties set out under section 1877(g) of the Act.

Comment:

One commenter questioned the guidance on resource use measures in the proposed rule with regards to dementia patients. The commenter stated that data on discharge to the community and data on preventable readmission rates for persons with dementia is limited. The commenter further stated that CMS could collect data on how many all-cause readmission beneficiaries have dementia.

Response:

Providers must use and share data on quality measures and data on resource use measures that are relevant and applicable to the patient's goals of care and treatment preferences. While we believe that resource use data can be helpful to all patients, providers can tailor the specific data that are given to patients so that the data are applicable to the patient's specific medical condition or circumstance. The provider should ensure that the data given to patients aligns with the patient's ultimate goals of care and treatment preferences.

The comments regarding the collection of quality measures are outside the scope of this final rule. However, we do appreciate the commenter's suggestion regarding data that pertain to patients with dementia.

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.

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. However, we note that Medicare and Medicaid participating facilities are surveyed regularly to assure quality, and we believe that Medicare facilities in good standing can be trusted to provide services safely.

Final Decision:

After consideration of the comments we received on the Discharge Planning proposed rule, we are finalizing and redesignating the proposed requirements at §§ 482.43(c)(8) and 485.642(c)(8) as §§ 482.43(a)(8) and 485.642(a)(8), respectively, without modification. We are finalizing and redesignating the requirements in proposed § 484.58(a)(6) as § 484.58(a), without modification.

C. Implementation

We solicited comments on the timeline for implementation of the discharge planning requirements for HHAs and CAHs. We received many comments in response to this solicitation for comments and recommendations on the effective date and the date of implementation of the discharge planning requirements in hospitals.

Comment:

Many commenters recommended a delay in the implementation or the effective date of the final discharge planning requirements for all providers. Most of these commenters noted that the proposed discharge planning requirements were extensive and that hospitals, HHAs, and CAHs would need additional time to understand and fully implement all the requirements, train staff, and update EHR systems to reflect the final discharge planning requirements. Recommendations for implementation timeframes or delays in the effective date included:

• 1 to 5 years, with several commenters specifically recommending a 1-year delay;

• Piloting discharge planning requirements before finalizing them;

• Phasing in the requirements; and

• A 2-year delay with implementation to begin with inpatients that hospitals determine are most at risk for readmission.

Many commenters were particularly concerned about the effective date for certain specific proposed requirements. Most suggested delaying the effective date for the discharge planning requirements of the IMPACT Act until quality reporting data is publicly available.

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. In addition, we are either revising or not finalizing most of our proposed discharge planning requirements, such as the design, applicability, and timeframe requirements for hospitals and CAHs, which will reduce additional burden. Therefore, we do not believe an additional delay in the effective date for hospitals and CAHs is necessary. 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. 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. We refer readers to the provider-specific sections II.C through II.E of this final rule, for a summary of the public comments we received, our responses to the comments, and the final requirements and to section II.B of this final rule for a discussion of the discharge planning requirements of the IMPACT Act and the measures that are currently publicly available.

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). Hospitals and CAHs will be required to comply with all of the final requirements 60 days after date of publication of this final rule.

D. Prescription Drug Monitoring Programs (PDMPs)

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). Given the potential benefits of PDMPs as well as some of the challenges noted in the proposed rule, we solicited comments on whether providers should be required to consult with their state's PDMP and review a patient's risk of non-medical use of controlled substances and substance use disorders as indicated by the PDMP report. We also solicited comments on the use of PDMPs in the medication reconciliation process.

Comment:

We received a large number of comments in response to our solicitation for comments on the use of PDMPs during the discharge planning process. A majority of commenters strongly disagreed with establishing a requirement for providers to consult with their state's PDMP, with most stating that such a requirement would be burdensome and time consuming for providers and their prescribing practitioners during the discharge planning process. A few commenters expressed specific concerns about the burden of such a requirement on CAH providers. One commenter expressed

concern about the applicability of this requirement to pediatric patients and recommended that this requirement be optional for pediatric patients under the age of 12. Many commenters agreed that PDMPs could potentially be useful, if the many challenges that currently exist within the PDMP systems are resolved. In addition, some commenters stated that PDMPs could work if there were a national or standardized PMDP database. In addition, one commenter requested clarification on how CMS expects providers to use PDMPs.

Several commenters agreed that many PDMPs still encounter legal, policy, and technical challenges. Many of these commenters raised issues of interoperability and noted that access to PDMPs varies widely by state and that data contained within their individual state's PDMP is often incomplete or out of date or provides limited access or access that is slow. Some commenters explained that there are additional challenges for providers whose patients cross multiple state lines, since PDMPs vary by state. One commenter questioned whether these hospitals would be required to check all state databases that are in their surrounding area.

Some commenters noted that their state did not have a PDMP. Other commenters noted that the proposed requirement would conflict with some state laws and requirements. These commenters indicated that state PDMP statutes were not enacted to assist discharge planning. A few commenters recommended deferring to the local state requirements while others specified the importance of addressing restrictions under the HIPAA Privacy Rule at § 164.510. A few commenters gave the example of Ohio as a state with a mandatory PDMP requirement. Ohio currently requires prescribing physicians and other prescribing practitioners to check the Ohio Automated Rx Reporting System (OARRS). 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.

Some commenters stated that HHAs in their state do not have access to their state's PDMP system; and that only pharmacists, prescribers, and law enforcement officials have access to the system. Other commenters noted that HHAs do not prescribe controlled substances or other types of medications.

A few commenters agreed with requiring providers to use PDMPs. Some other commenters supported CMS' continued encouragement of the use of PDMPs, but encouraged CMS not to mandate the use of PDMPs. One commenter stated that a mandatory requirement should not be instituted for providers; instead, each facility should be able to determine whether use of the PDMP is appropriate or necessary on an individual patient level. One commenter stated that PDMPs should only apply to the prescription of controlled substances until the universal use of PDMPs is better understood.

Response:

We thank the commenters for their feedback. We received many comments that stated that we had proposed PDMP requirements for providers and many of these comments recommended that we not finalize, or delay finalization, of this proposal. However, we clarify that we did not propose PDMP requirements, and solely solicited comments in the proposed rule on whether provider consultations with PDMPs during the discharge planning process should be required.

Final Decision:

After taking into consideration the comments received in response to our solicitation of comments for PDMPs, we agree that it would be difficult to implement a mandatory requirement for providers to access their state's PDMP during the discharge planning process at this time. We appreciate stakeholder input on this issue. We will not require that hospitals, including LTCHs and IRFs, HHAs or CAHs consult with their state's PDMP and review a patient's risk of non-medical use of controlled substances and substance use disorders as indicated by the PDMP report, nor will we require providers to use or access PDMPs during the medication reconciliation process. However, as discussed in the proposed rule, we strongly encourage practitioners to utilize strategies and tools, such as PDMPs, to the extent permissible under the HIPAA Privacy Rule and state law, to help to reduce prescription drug misuse. Furthermore, we note that there may be state laws that require practitioners to consult with their state's PDMP system and we acknowledge that since the publication of the proposed rule, additional states have adopted statewide PDMP programs. We therefore remind providers that they must continue to abide by all applicable state laws.

E. Patients' Rights and Discharge Planning in Hospitals

1. Patient's Access to Medical Records (Proposed § 482.13(d)(2))

In the Hospital Innovation proposed rule, we proposed clarifying the requirement for hospitals at § 482.13(d)(2) to state that the patient has the right to access their medical records, including current medical records, upon an oral or written request, in the form and format requested by the individual, 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 individual, within a reasonable time frame (81 FR 39475). We also note that our use of terms “patients” and “medical records” instead of the HIPAA-defined terms “individual,” “protected health information,” and “designated record set” is not intended to suggest a different standard for covered entities subject to the HIPAA Privacy Rule. (See 45 CFR 164.524). We simply are using well-understood terms that are consistent across all of our regulations. 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.

) Individuals who have not been provided with their medical records within the 30-day timeframe required by HIPAA or who experience other difficulties accessing their medical records can file a complaint with Office for Civil Rights at:

http://www.hhs.gov/hipaa/filing-a-complaint/index.html.

We also refer the public to the following information pertaining to the Promoting Interoperability Program (formerly known as the EHR Incentive Program) and to an individual's rights under HIPAA to access their health information at the following websites:

https://www.hhs.gov/hipaa/for-professionals/faq/2051/under-the-ehr-incentive-program-participating-providers/index.html

and

https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/access/index.html.

Comment:

Commenters were generally supportive of this proposal.

Some 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. One commenter recommended that the regulation specify that discharge planning documents be immediately accessible to patients and their caregivers. The commenter notes that under the current medical record requirement (most likely the commenter is referring to § 482.24), it is difficult for caregivers to obtain a medical record from a hospital until after discharge, even with the patient's signed consent.

Response:

This final rule states that the patient has the right to access their medical records in the form and format they request, if it is readily producible in such form and format. The medical record must include any discharge planning documents, so it is not necessary for this requirement to specify any specific part of the medical record as requested by the commenter. Patients are free to request their entire medical record or a specific portion of it if they choose, including any discharge planning documents, as noted by the commenter. However, these documents (and, by extension, the entire medical record) would obviously not be complete until after a patient is discharged. Further, the provision goes on to state that if the records are not readily producible in the form or format requested by the patient, the hospital must provide the records in a readable hard copy form or such other form and format as agreed to by the facility and the individual. We encourage hospitals to communicate with the patient to determine in which format they would prefer to receive the records; however, if no format is requested, the hospital has the flexibility to provide the records in a readable hard copy form.

Final Decision:

After consideration of the comments we received on this proposal for the Hospital Innovation proposed rule, we are finalizing § 482.13(d)(2) with two minor editorial modifications.

We are moving the phrase “including current medical records” to a more appropriate place in the text, that is, immediately following the opening language of the provision, “The patient has the right to access their medical records,” so that it now reads, “The patient has the right to access their medical records, including current medical records . . .”

In the proposed rule, we had awkwardly and inadvertently placed the phrase further along so it stated that the patient has the right to access their medical records, upon an oral or written request, in the form and format requested by the individual, 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 individual,

including current medical records,

within a reasonable time frame.

In removing the phrase from where it was proposed in the regulatory text, we have also added the word, “and” to precede the phrase, “within a reasonable time frame,” so that it now more appropriately reads, “. . .

and

within a reasonable time frame.”

2. Conditions of Participation (CoP)—Discharge Planning (Proposed § 482.43)

We proposed to revise the existing requirements in the form of 6 standards at § 482.43. The most notable proposed revision was to require that all inpatients and specific categories of outpatients be evaluated for their discharge needs and have a written discharge plan developed. We proposed to retain many of the current discharge planning concepts and requirements, but proposed to revise them to provide more clarity and to place emphasis on the development of each patient's individual discharge plan as opposed to the burdensome, current requirements that place more emphasis on the evaluations to determine which patients need discharge plans. We also proposed to require specific discharge instructions for all patients.

We proposed to continue our efforts to reduce unnecessary and costly patient readmissions by improving the discharge planning process that would require hospitals to take into account the patient's goals and preferences in the development of their plans and to better prepare patients and their caregiver/support persons (or both) to be active participants in self-care and by implementing requirements that would improve patient transitions from one care environment to another, while maintaining continuity in the patient's plan of care. The following is a discussion of each of the proposed standards.

We proposed at § 482.43, Discharge planning introductory paragraph, to require that a hospital have an effective discharge planning process that focuses on the patients' goals and preferences and on preparing patients' and, as appropriate, their caregivers/support person(s) to be active partners in their post-discharge care, ensuring effective patient transitions from hospital to post-acute care while planning for post-discharge care that is consistent with the patient's goals of care and treatment preferences, and reducing the likelihood of hospital readmissions.

Our proposed hospital regulatory requirements were the basis for all other proposed discharge planning requirements as set out in the proposed rule. Since application of the proposed regulatory language for hospitals might be burdensome for CAHs and HHAs, we tailored specific proposed requirements to each providers' and suppliers' unique situation.

Many commenters remarked on the proposed discharge planning regulations for hospitals, but indicated that their comments could also be applied to CAHs. Therefore, where appropriate, we included CAHs in this section of the final rule.

Comment:

Most commenters strongly supported a person-centered approach that places the patient at the center of the discharge planning process by requiring hospitals to develop and implement a discharge planning process that focuses on the patient's goals and preferences. Several of these commenters expressed concern that these proposed discharge planning requirements were unclear.

Response:

We thank the commenters for their feedback regarding a person-centered approach to discharge planning. We continue to believe that hospitals should take into consideration a patient's goals of care and treatment preferences and we note that person-centered care is particularly important when patients are discharged to home or to community-based services. In response to the public comments that we received that expressed concern about the clarity of the proposed discharge planning requirements, we have revised the wording of the requirements. Specifically, we are finalizing the discharge planning introductory paragraph with minor changes in § 482.43, and we are continuing to emphasize the importance of the consideration of the patient's goals of care and treatment preferences during the discharge planning process and within the discharge plan. 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.

Final Decision:

After consideration of the comments we received on the proposed rule, we are finalizing the first sentence in the introductory paragraph

of § 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 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. The remaining language for the introductory paragraph remains the same.

3. Design (Proposed § 482.43(a))

We proposed to establish a new standard, at § 482.43(a), “Design,” and would require that hospital medical staff, nursing leadership, and other pertinent services provide input in the development of the discharge planning process. We also proposed to require that the discharge planning process be specified in writing and be reviewed and approved by the hospital's governing body. We would expect that the discharge planning process policies and procedures would be developed and reviewed periodically by the hospital's governing body.

Comment:

A number of commenters approved of the proposed new standard at § 482.43(a), including one commenter that noted that physician involvement in the design of a hospital's discharge policies and procedures is essential to its success. Several commenters submitted comments questioning the proposed requirements regarding the role of the governing body, medical staff, and relevant departments in relationship to developing the discharge planning process, and suggested that the final regulations be much less prescriptive regarding these roles. One commenter questioned the practical enforceability of the requirement for a hospital to have its discharge planning process in writing and approved by the hospital's governing body. Many commenters made suggestions for additions of specific disciplines and entities to be consulted when developing the discharge planning process. 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. Another commenter suggested that there should be a requirement for performance metrics as part of the design of a discharge process so as to inform formative assessment of policies, plans, and procedures, and their success or need for change. Still other commenters recommended that CMS not be overly prescriptive in the proposed design of the discharge planning process, and recommended that CMS put forward a design approach that would allow for customization based on patient needs. 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.

Response:

Based on the comments that we received, we agree with commenters who stated that this proposal was too process-oriented and too prescriptive. Further, we believe that any additional requirements added to this section would make the discharge planning requirements even more prescriptive and burdensome, which would not reflect the concerns expressed by the majority of commenters. We therefore are not finalizing the requirements in § 482.43(a). Hospitals and CAHs may choose to include any of the factors that we originally proposed, as well as those described by commenters, in designing their discharge planning process. We encourage hospitals and CAHs to consider performance metrics when designing their discharge processes. We also encourage the use of performance metrics for hospitals when they reassess their discharge planning processes on a regular basis and urge hospitals to consider including these reassessments as projects within their Quality Assessment and Performance Improvement (QAPI) programs.

Comment:

Several commenters recommended that CMS require hospitals to review their discharge planning processes every 2 years.

Response:

We continue to believe that hospitals and CAHs should assess their discharge planning processes on a regular basis. However, we believe that it is not appropriate, and is in fact unduly burdensome, to establish a specific timeframe for this review. We believe that each hospital and CAH should have the flexibility to establish its own timeframe for periodic review. While we are not establishing a specific timeframe requirement in order to preserve flexibility for hospitals and CAHs, we would recommend that a hospital or CAH to do its periodic review every 2 years at a minimum. In addition, hospitals and CAHs would still have the flexibility to perform this review more frequently than every 2 years if they wish to do so.

We therefore are finalizing a provision at § 482.43(a)(7) (as originally proposed at § 482.43(c)(10)) that would require a hospital (or a CAH) to assess its discharge planning process 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:

One commenter recommended that the final rule include an explicit requirement that a hospital's discharge policies and procedures accommodate the needs of patients whose primary language is not English.

Response:

As we noted previously, and in order to encourage patient engagement and understanding of their discharge plan or instructions, we recommend providers follow the National Standards for Culturally and Linguistically Appropriate Services (CLAS) in Health and Health Care (

https://www.thinkculturalhealth.hhs.gov/clas/standards

), which provide guidance on providing instructions in a culturally and linguistically appropriate manner.

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).

4. Applicability (Proposed § 482.43(b))

We proposed to revise the current requirement (§ 482.43(a)), which requires a hospital to identify those patients for whom a discharge plan is necessary at proposed § 482.43(b), “Applicability.” We proposed to require that the discharge planning process apply to all inpatients, as well as certain categories of outpatients, including, but not limited to patients receiving observation services (since these patients are often kept in the hospital overnight), patients who are undergoing surgery or other same-day procedures where anesthesia or moderate sedation is used, emergency department patients who have been identified by a practitioner as needing a discharge plan, and any other category of outpatient as recommended by the medical staff, approved by the governing body, and specified in the hospital's discharge planning policies and procedures. We thought at the time that the aforementioned categories of patients would benefit from an evaluation of

their discharge needs and the development of a written discharge plan.

Comment:

While a number of commenters agreed with the proposal to broaden the categories of patients who would be evaluated for post-discharge need, stating that they believed the inclusion of these categories of patients was necessary for effective transition from acute settings to post-acute settings, the majority of commenters expressed concern over the undue burden that they believe would result from this proposed change, particularly for small and rural hospitals. Many stated that they believe that the current evaluation requirement is effective for screening and targeting high-risk patients who have true discharge needs. 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.

Response:

We agree with commenters that the requirement needs to be scaled back in its scope and applicability to a more flexible requirement. 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. 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. We therefore are not finalizing the requirements at proposed § 482.43(b). 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. In addition, at § 482.43(a)(2), a discharge planning evaluation must 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, and home health services, and must also determine the availability of those services.

The regulatory flexibility and framework of these final requirements will allow each hospital to establish and tailor its own policy parameters for discharge planning evaluations according to its specific patient populations, individual institutional needs and resources, and own medical staff recommendations as long as the policies and procedures established and implemented meet or exceed the requirements finalized in this rule.

Final Decision:

After consideration of the comments we received on the proposed rule, we are revising proposed § 482.43(b), to be finalized as § 482.43(a) introductory text and (a)(2), to require that the hospital's discharge planning process 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. A discharge planning evaluation must 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, and home health services; such evaluation must also determine the availability of those services.

5. Discharge Planning Process (Proposed § 482.43(c))

We proposed at § 482.43(c), “Discharge planning process,” to require that hospitals implement a discharge planning process to begin identifying, early in the hospital stay, the anticipated post-discharge goals, preferences, and needs of the patient and begin to develop an appropriate discharge plan for the patients identified in proposed § 482.43(b). We proposed to require that the discharge plan be tailored to the unique goals, preferences, and needs of the patient. We proposed 10 specific elements to be addressed in the discharge planning process as follows:

• Proposed § 482.43(c)(1): We proposed that an RN, social worker, or other personnel qualified in accordance with the hospital's discharge planning policy, coordinate the discharge needs evaluation and the development of the discharge plan.

• Proposed § 482.43(c)(2): We proposed to require that a hospital must begin to identify anticipated discharge needs for each applicable patient within 24 hours after admission or registration, and the discharge planning process is completed prior to discharge home or transfer to another facility and without unduly delaying the patient's discharge or transfer. If the patient's stay was less than 24 hours, the discharge needs would be identified prior to the patient's discharge home or transfer to another facility.

• Proposed § 482.43(c)(3): We proposed to retain and clarify the current requirement at § 482.43(c)(4), regarding reassessment of the plan as necessary. We also proposed to require that the hospital's discharge planning process ensure an ongoing patient evaluation throughout the patient's hospital stay or visit in order to identify any changes in the patient's condition that would require modifications to the discharge plan.

• Proposed § 482.43(c)(4): We proposed 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.

• 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. We proposed that hospitals consider the patient's or caregiver's capability and availability to provide the necessary post hospital care. We proposed that hospitals consider the availability of, and access to, non-health care services for patients. We proposed that hospitals consider the following in evaluating a patient's discharge needs, including, but not limited to:

• Admitting diagnosis or reason for registration;

• Relevant co-morbidities and past medical and surgical history;

• Anticipated ongoing care needs post-discharge;

• Readmission risk;

• Relevant psychosocial history;

• Communication needs, including language barriers, diminished eyesight and hearing, and self-reported literacy of the patient, patient's representative or caregiver/support person(s), as applicable;

• Patient's access to non-health care services and community-based care providers; and

• Patient's goals and treatment preferences.

• Proposed § 482.43(c)(6): We proposed a new requirement that the patient and the caregiver/support person(s), be involved in the development of the discharge plan and

informed of the final plan to prepare them for post-hospital care.

• Proposed § 482.43(c)(7): We proposed a new requirement that the patient's discharge plan address the patient's goals of care and treatment preferences.

• Proposed § 482.43(c)(8): We proposed that the hospital assist patients and their families in selecting a post-acute care provider by using and sharing data on quality measures and data on resource use measures as is relevant and applicable to the patient's goals of care and treatment preferences.

• Proposed § 482.43(c)(9): We proposed to require that the patient's discharge needs evaluation and discharge plan be documented and completed on a timely basis, based on the patient's goals, preferences, strengths, and needs, so that appropriate arrangements for post-hospital care could be made before discharge.

• Proposed § 482.43(c)(10): We proposed to require hospitals to assess their discharge planning processes on a regular basis, including ongoing review of a representative sample of discharge plans, including patients who were readmitted within 30 days of a previous admission, to ensure that they are responsive to patient discharge needs.

Comment:

Numerous commenters expressed overall disagreement with the overly detailed, prescriptive nature of the proposed requirements. While they supported the overall goal of improving discharge planning, commenters expressed concern about stifling innovation, interfering with patient-provider relationships, overburdening discharge planning staff, and diverting patient care resources to regulatory process requirements.

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. In light of the concerns expressed by commenters, we have significantly revised the proposed requirements to focus less on specific processes and prescriptive elements, and more on overall outcomes and flexibilities. We have also reorganized and simplified the regulatory requirements (such as those originally proposed in § 482.43(c)(9) and (10)), where appropriate, to improve their clarity and understandability.

Comment:

A small number of commenters recommended that we mandate that nurses with training and experience in rehabilitation, as well as respiratory therapists, be involved in the discharge needs evaluation and in the development of the discharge plan.

Response:

We do not believe that it is appropriate to require hospitals to use certain specialty practitioners in any particular step of the discharge planning process. However, hospitals are not precluded from doing so. We believe that the requirements should allow hospitals to determine what is appropriate for its patient population and its facility in such circumstances.

Comment:

The majority of commenters opposed the establishment of a specific timeframe of 24 hours after admission or registration for beginning to identify anticipated discharge needs for each applicable patient (proposed § 482.43(c)(2)). Some commenters noted that applying a 24-hour requirement, without consideration of patient need, could result in a waste of valuable hospital resources or inaccurate conclusions.

Response:

We agree with commenters that setting rigid time frames may not take into account the facts and circumstances of a particular patient's care; therefore, we are removing this proposed requirement from this final rule.

Comment:

Several commenters supported our proposal to require that the hospital's discharge planning process require a regular re-evaluation of the patient's condition to identify changes that require modification of the discharge plan and that the discharge plan be updated, as needed, to reflect these changes. However, one commenter asserted that this requirement is redundant, as it is already included in the regular course of care for patients. Another commenter supported the proposed requirement and noted that the needs of patients with dementia and their caregivers evolve frequently.

Response:

We continue to believe in the importance of requiring that hospital's discharge planning process require a regular re-evaluation of the patient's condition to identify changes that require modification of the discharge plan and that the discharge plan be updated, as needed, to reflect these changes. 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). We are finalizing the requirement from proposed § 482.43(c)(3) with modifications at § 482.43(a)(6) in this final rule to require regular re-evaluation of the patient's condition to identify changes that require modification of the discharge plan. The discharge plan must be updated, as needed, to reflect these changes. We note that these requirements would allow for hospitals to consider the specific needs of patients with dementia.

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.

Response:

The interpretive guidance is developed in accordance with the CoP regulations. Therefore, while the interpretive guidance will further clarify the CoPs, they will not impose additional requirements beyond those in the CoPs.

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. The commenter asked whether the practitioner will always be a hospital-based provider or the patient's personal physician. One commenter noted that this requirement would be difficult to complete for a medically complex patient with multisystem involvement. One commenter opposed the inclusion of this requirement in the CoPs for hospitals on the basis that hospitals do not control practitioner-patient interaction. The commenter also noted the absence of an explanation regarding the language stating that a practitioner should be “involved in” the process.

Response:

We agree that the proposed requirement does not allow for flexibility for hospitals, CAHs, and practitioners, especially for multi-facility providers that treat medically complex patients. Taking into account the concerns that we have received on this proposal, we are not finalizing the proposed requirements in § 482.43(c)(4).

Comment:

Many commenters supported the proposed requirement for hospitals to consider certain criteria while evaluating a patient's discharge needs, specifically highlighting proposals related to psychiatric and behavioral health needs, and non-medical needs and support services. Some commenters suggested that hospitals should be required to inform patients and their caregivers of their right to receive post-acute care in their home or a community setting, as is appropriate for the patient's care and

needs, so long as the placement can be reasonably accommodated. One commenter recommended that hospitals review a patient's need for the use of technology and whether or not technology is necessary to maintain a patient's health and safety or individual goals. A few commenters recommended specific revisions to the proposed requirement that the hospital consider the availability of caregivers and community-based care for each patient, including recommendations such as requiring hospitals to consider a patient's socioeconomic condition when identifying and evaluating a patient's anticipated post-discharge needs, and consider patient eligibility for Program of All-Inclusive Care for the Elderly (PACE) and services through the Veterans Administration.

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. A few commenters stated that a requirement to consider a patient's access to non-health care services and community-based care providers would be burdensome for hospitals. One commenter stated that while these services may benefit the patient, hospitals cannot be expected to provide an exhaustive list of services and that the hospital has limited reliable methods to identify non-health care resources in the community.

One commenter disagreed with the use of the term “consider” in the proposed requirement, stating that using the term “consider” may cause interpretation differences when surveying for compliance. The commenter recommended that CMS clarify that discharge plans can vary, depending on the patient, and that in many cases a patient's discharge instructions could constitute a “discharge plan.” The commenter also recommended that CMS coordinate with AOs to develop mutually agreed upon interpretive guidelines, which all surveyors would use when assessing compliance with this provision.

Response:

We agree that the proposed list could be burdensome, and, therefore, we are not finalizing it in this final rule. 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.

We acknowledge that patients and families seeking post-hospital non-health care services, as well as the discharge planning staff of hospitals assisting them with this process, frequently find themselves confronted with what can be an overwhelming number of organizations and requirements. This search occurs at a time of vulnerability or crisis, and can result in patients, families, and caregivers making decisions based on incomplete, and sometimes inaccurate, information about their options. In partnership with the Veterans Health Administration and the Administration for Community Living (ACL) within HHS, CMS is working collaboratively with states to streamline access to long-term services and supports (LTSS) through a network of organizations, including Aging & Disability Resource Centers (ADRCs), Area Agencies on Aging (AAAs), and Centers for Independent Living (CILs)) that make up a statewide No Wrong Door (NWD) system. We expect that CILs, AAAs, and ADRCs would assist patients in accessing LTSS, and would have staff trained to help patients and their families exercise their choice and control over the types of LTSS that work best for them in their lives. Along with the U.S. Department of Veterans Affairs, CMS formally recognized the importance of state ADRC/NWD systems by publishing the NWD System Medicaid Administrative Guidance (

https://www.medicaid.gov/medicaid/financing-and-reimbursement/downloads/no-wrong-door-guidance.pdf

) and the “Expanded Access to Non-VA Care Through the Veterans Choice Program Rule” interim final rule (80 FR 674991, December 1, 2015.)

We therefore urge hospitals to develop collaborative partnerships with these community based care organizations in their respective areas to improve transitions of care that might support better patient outcomes. Regarding hospital expectations, hospitals are required to comply with all applicable Federal laws, including the Americans with Disabilities Act (ADA). It is our expectation that hospitals would administer their services, programs, and activities in the most integrated setting appropriate to individuals with disabilities, in compliance with the ADA. For further information on ADA compliance, we recommend that readers visit

https://www.ada.gov/.

For further information about other nondiscrimination laws see

http://www.hhs.gov/civil-rights.

We expect hospitals to develop collaborative relationships with their area and state ADRCs, AAAs, and CILs that are knowledgeable of the availability of these services in the community and would be able to help connect patients as well as their families, friends, and caregivers to these resources. We would also expect that these hospital efforts to collaborate and to connect patients with these types of community-based care organizations will be documented in the medical record. It is for this reason that we urge hospitals to develop ongoing and collaborative partnerships with ADRCs, AAAs, and CILs. We remind hospitals that they can find more information on community-based services and community-based organizations at

http://www.acl.gov/.

Considerations must also be made for those patients whose personal homes have been adversely impacted due to an emergency or disaster. 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). Therefore, in the event of such an emergency, we would expect that patients that are determined for safe discharge to a personal home that may have been adversely impacted should not be directed to shelters without prior consultation with public health and emergency management officials overseeing those shelters. Additionally, we would expect that patients that are anticipated to be discharged to another inpatient facility that may be adversely impacted should not be sent to a shelter without prior consultation with public health and emergency management officials overseeing those shelters and with health care coalitions, where available, that may know of other inpatient facility options. In addition, we refer readers to guidance from Office for Civil Rights on emergency preparedness and ensuring at risk individuals have access to emergency services at the following link:

https://www.hhs.gov/civil-rights/for-individuals/special-topics/emergency-preparedness/index.html.

Comment:

We received several comments regarding community based care organizations. Comments included the following recommendations:

• Mandate that providers collaborate and coordinate with community based organizations on the availability of community supports at discharge.

• Include specific references to CILs, ADRCs, and AAAs in the regulation and provide patient instructions on their use.

• Clarify how collaboration between hospitals and community based organizations would be encouraged and funded, including requiring Medicare and Medicaid reimbursement of AAAs and community-based organizations.

• Require that community based providers be included in the early stages of planning for a patient's discharge.

• Clarify how a hospital would know what facility or agency a patient would use before discharge.

• Clarify timelines for considering the availability of, and access to, non-health care services for patients, specifically in instances where the post-acute care provider had a physical accessibility issue.

Response:

As we have already stated in this final rule, we believe that community based care organizations, including CILs, ADRCs, and AAAs, play an important part in helping individuals, who are returning home or who want to avoid institutionalization, by connecting them to community services and supports. Currently, many of these organizations already help older adults and people with disabilities with transitions across settings, from hospitals and PAC settings back to home. Because of the important role that community based organizations play, we strongly encourage hospitals to develop collaborative partnerships with providers of community-based services. We believe that such collaboration will help with successful patient transitions.

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. 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. Such an approach runs counter to current CMS initiatives to place patients over paperwork. Hospitals should be afforded the flexibility to provide information about these organizations and collaborate with these entities as is appropriate for the patient and based on the patient's goals of care and treatment preferences. We expect that hospitals would be responsive to the patient regarding his or her needs and provide information to the patient about these organizations as well as form collaborative relationships with these entities as appropriate.

This final rule does not mandate a specific methodology for how collaboration between hospitals and community based providers should be conducted nor does it mandate that hospitals (when developing a patient discharge plan) must consider a patient's eligibility for community based services, any patient wait lists for services, or any time frames established by community based providers for the initiation of services. We believe that such detailed mandates would be overly burdensome for hospitals and inappropriate for these regulations. However, as we stated above, we are finalizing a requirement at § 482.43(a)(2) that a hospital include an evaluation of a patient's likely need for appropriate non-health care services and community based care providers, and must also include a determination of the availability of, and the patient's access to, those services as part of the patient's discharge planning evaluation. We encourage hospital personnel to be knowledgeable about the services that are provided by their local community based organizations and expect hospital personnel to be able to offer their patients guidance on how to connect with their local community based organizations. Once a patient is discharged, we would not expect hospitals and CAHs to be responsible for ensuring that a patient has received non-health care services (including home modifications), as this would be outside the scope of a hospital's or CAH's responsibility. 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. We also do not believe that hospitals and CAHs should hold patients until physical accessibility issues are resolved, although we understand that sometimes hospitals hold patients until a bed is available at a corresponding PAC facility. Hospitals and CAHs can provide patients with resources regarding supportive housing and home and physical environment modifications including assistive technologies and, where appropriate, medical equipment and supplies, including back-up batteries. We refer readers to further guidance that can be found in the previously provided web links in the discussion on the proposed requirements for § 482.43(c)(5) and on the final requirements for § 482.43(a)(2) of this final rule.

Finally, comments regarding funding for community based organizations are outside the scope of this rule.

Comment:

Many commenters supported the proposal to require that the discharge plan address the patient's goals of care and treatment preferences. A few commenters asked for clarification on how hospitals will be expected to demonstrate the incorporation of the patient's goals and wishes into the plan. 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. The commenters noted that hospitals should try to work with the patients as much as possible and should not be penalized if patients decline medical or discharge planning assistance. One commenter stated that sometimes patient goals and preferences are not consistent with the clinical needs of the patient or the resources available to the patient post-discharge. Therefore, the commenter concluded that the patient's goals and preferences cannot be fully accommodated in the final discharge plan. 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:

While we are modifying this proposal by finalizing it in the introductory paragraph at § 482.43, we note that we still expect that the patient's goals of care and treatment preferences would be included in the patient's medical records. Similarly, we understand that situations may arise where patients may be uncooperative or may refuse to participate in the discharge planning process. We also expect hospitals and CAHs to document the patient's refusal to participate in the discharge planning process, and that such attempts to incorporate the patient and/or the patient's caregiver in the discharge planning process were made, in the medical record. While we understand the commenter's concerns that a patient's goals of care and treatment preferences might not always align with the practitioner's recommended medical care, we continue to believe that it is important for hospitals and CAHs to develop and implement an effective discharge planning process that focuses on and,

where appropriate, is consistent with the patient's goals and preferences. We expect that these goals and preferences will be included in the discharge plan and would reasonably relate to the patient's medical care or treatment preferences, preferred non-health care services, post-acute care, or community-based care post-hospitalization. While we expect that practitioners will establish the most appropriate course of care for their patient and document this in the patient's discharge plan, we note that patients cannot be forced to follow their discharge plan and that patients have the right to refuse treatment or to leave the hospital or CAH against medical advice.

Final Decision:

After consideration of the comments we received on the proposed rule, we are finalizing the discharge planning requirements with the following modifications:

• Revising the language in the introductory paragraph of § 482.43.

• 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).

• 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.

• Withdrawing our proposal at § 482.43(c) to require that the hospital's discharge planning process must ensure that the discharge goals, preferences, and needs of each patient are identified and result in the development of a discharge plan for each patient in accordance with paragraph (b) of this section.

• Revising and redesignating the requirements in proposed § 482.43(c)(1) to state that any discharge planning evaluation or discharge plan required under this paragraph must be developed by, or under the supervision of, a registered nurse, social worker, or other appropriately qualified personnel. We are finalizing these requirements as § 482.43(a)(5).

• Revising and redesignating § 482.43(c)(2) to eliminate the 24-hour time frame requirements and retaining, with minor revisions, the current requirements at § 482.43(a) to state that the hospital must identify at an early stage of hospitalization all patients who are likely to suffer adverse health consequences upon discharge if there is no adequate discharge planning. 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. We are finalizing these requirements as § 482.43(a).

• Finalizing proposed § 482.43(c)(3) without modification and redesignating these requirements as § 482.43(a)(6) to state that 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. The discharge plan must be updated, as needed, to reflect these changes. Withdrawing proposed § 482.43(c)(4). Revising § 482.43(c)(5) to state that a discharge planning evaluation must 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, and home health services, and non-health care services and community based care providers, and must also determine the availability of the appropriate services as well as of the patient's access to those services. We are including these requirements as § 482.43(a)(2).

• Revising § 482.43(c)(6) to state that the discharge planning evaluation must be included in the patient's medical record for use in establishing an appropriate discharge plan and the results of the evaluation must be discussed with the patient (or the patient's representative). This requirement will be included in § 482.43(a)(3).

• Modifying § 482.43(c)(7) by requiring that hospitals 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. 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. These requirements are included in the introductory paragraph at § 482.43.

• Modifying the requirements at proposed § 482.43(c)(9) to state that 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. We are finalizing these requirements in § 482.43(a)(1).

• We are making a technical revision to the proposal at § 482.43(c) to clarify the intent of the requirements related to

post-acute care services.

This requirement applies to patients whose discharge plan includes a referral to HHA services or transfer to a SNF, IRF, or LTCH.

6. Discharge to Home (Proposed § 482.43(d))

We proposed to re-designate and revise the current requirement at § 482.43(c)(5) (which currently requires that as needed, the patient and family or interested persons be counseled to prepare them for post-hospital care) as § 482.43(d), “Discharge to home,” to require that the discharge plan include, but not be limited to, discharge instructions for patients described in proposed § 482.43(b) in order to better prepare them for managing their health post-discharge. The phrase “patients discharged to home” would include, but not be limited to, those patients returning to their residence, or to the community if they do not have a residence, and who require: Follow-up with their PCP and/or a specialist and who might also be receiving post-acute care from HHAs, hospice services, and/or any other type of outpatient health care services. The phrase “patients discharged to home” would not refer to patients who are transferred to another inpatient hospital or CAH, inpatient hospice facility, or a SNF.

Proposed § 482.43(d)(1): We proposed that discharge instructions must be provided at the time of discharge to patients, or the patient's caregiver/support person(s) (or both), who are discharged home and who also might be referred to PAC services. We also proposed that practitioners/facilities (such as an HHA or hospice agency and the patient's PCP), receive the patient's discharge instructions at the time of discharge if the patient is referred to follow-up PAC services.

Proposed § 482.43(d)(2): We proposed to set forth the minimum requirements for discharge instructions as follows: Instructions to the patient and his or her caregivers about care duties that they would need to perform in the patient's home as determined in the patient's discharge plan; written information on the warning signs and symptoms that

patients and caregivers should be aware of with respect to the patient's condition; all medications prescribed and over-the-counter for use after the patient's discharge from the hospital (with reconciliation of all medications used by the patient prior to admission), including the name, indication, and dosage of each medication along with any significant risks and side effects of each drug as appropriate to the patient; written instructions, in paper or electronic format (or both), provided to the patient; and documenting follow-up care, appointments, pending and/or planned diagnostic tests, and any pertinent telephone numbers for practitioners that might be involved in the patient's follow-up care or for any providers/suppliers to whom the patient has been referred for follow-up care.

Proposed § 482.43(d)(3): We proposed to require hospitals send the following information to the practitioner(s) responsible for follow-up care, if the practitioner has been clearly identified: A copy of the discharge instructions and the discharge summary within 48 hours of the patient's discharge; pending test results within 24 hours of their availability; and all other necessary information, as specified in proposed § 482.43(e)(2).

Proposed § 482.43(d)(4): We proposed to require, for patients discharged to home, that the hospital establish a post-discharge follow-up process.

Comment:

Numerous commenters expressed overall disagreement with the overly detailed, prescriptive nature of the proposed requirements. While they supported the overall goal of improving discharge planning, commenters expressed concern about overburdening discharge planning staff, duplicating existing hospital discharge planning practices, and diverting patient care resources to regulatory process requirements.

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. In light of the concerns expressed by commenters, we have removed the majority of the proposed requirements, specifically those at § 482.43(d)(1), (2), and (4), and have significantly revised the requirements of proposed § 482.43(d)(3) to reduce regulatory burden.

Comment:

Several commenters supported the proposal to provide discharge instructions to the patient and/or the patient's caregiver/support person(s), and the PAC provider or supplier, if the patient is referred to PAC services. Additionally, some commenters sought clarification regarding specific issues, such as whether hospitals could share post-hospital care instructions with the patient and/or the patient's caregiver prior to actual discharge and whether there would be HIPAA violations when a hospital sent discharge instructions to the PAC provider or supplier.

Response:

Although we are not finalizing this requirement as proposed, hospitals or CAHs are not prevented from developing discharge instructions or sharing discharge information in accordance with applicable law earlier than the time of discharge. Additionally, we note that providing a patient with his or her discharge instructions is a long-standing standard of practice for hospitals when discharging inpatients as well as when releasing patients from care in other areas of the hospital (for example, the emergency and ambulatory surgery departments). Because of this, we believe that it is unnecessary to specifically require it here, but we encourage hospitals and CAHs to continue this long-standing standard of practice that serves as a simple way of not only informing, but also engaging, the patient (and/or the patient's caregiver/support person(s)) regarding his or her continued care upon discharge from the hospital or CAH. We note hospitals, HHAs, and CAHs are required to send certain discharge information to the PAC provider or practitioner(s) responsible for follow-up care, if the practitioner is known and has been clearly identified. We have no reason to believe that sending discharge information to such PAC providers or suppliers would be considered a HIPAA violation, since disclosures for treatment, care coordination, and quality improvement purposes are generally permitted under 45 CFR part 164.

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.

Response:

While we are not finalizing the proposed discharge instruction requirements discussed here (in response to public comments that noted the overly detailed, prescriptive nature of these proposed requirements) and although we also did not propose requirements that included the commenters' recommendations, we would still like to encourage hospitals to consider these recommendations for their discharge planning processes. Therefore, we refer readers to the following links for more information regarding the use of the “teach-back” method during the discharge planning process as well as for additional information on the National CLAS standards:

•

https://www.thinkculturalhealth.hhs.gov/clas/standards.

•

http://www.teachbacktraining.org.

Comment:

A few commenters submitted comments regarding documentation. One commenter stated that hospitals should be required to include the patient's discharge instructions in the medical record, and that the medical record should also include documentation that the patient and caregiver were offered a demonstration of post-discharge care tasks and an opportunity to ask questions and receive answers on post-discharge care. A few commenters asked for clarification on the documentation requirements for patients that leave against medical advice.

Response:

We encourage hospitals and CAHs to document interactions with patients and/or their caregivers in the medical record as a best practice. Patient discharge instructions, as part of the record of patient care in the hospital, are already required to be included in the medical record under the Medical Record Services requirements in § 482.24, so no new requirement is needed here. We understand that situations may arise where patients may prefer not to participate in the discharge planning process. For patients that decline to participate in the discharge planning process or leave the hospital or CAH against medical advice, we expect hospitals to document in the medical record the patient's refusal to participate in the discharge planning process, and that such attempts to include the patient and/or the patient's caregiver in the discharge planning process were made by hospital staff.

Comment:

We received several comments related to the content and implementation of the proposed discharge instructions requirement. While some commenters suggested that CMS include even more specificity in the requirements, most expressed concern that CMS was requiring too much information be provided to the patient upon discharge, and that CMS should not mandate what should be included in the discharge instructions. One commenter also disagreed with the requirement that discharge instructions

be written, and requested that CMS allow for other communication methods to share this information with patients.

Response:

We believe that the requirements of this section, as proposed, are overly prescriptive and we do not believe that it is appropriate to finalize a requirement that hospitals must provide specific written discharge instructions to patients. We believe that the overall involvement of the patient and caregivers, as set forth in §§ 482.43 and 485.642, in addition to the already established practice of providing discharge instructions appropriate to each patient as is the current standard of care, will ensure appropriate communication between providers, patients, and caregivers throughout the discharge planning process.

Comment:

A few commenters asked about the role that Prescription Drug Monitoring Programs (PDMPs) should play in the discharge planning process.

Response:

As part of the medication reconciliation process, in the proposed rule we encouraged practitioners to consult with their state's PDMPs. We also solicited comments on whether providers should be required to consult with their state's PDMP and review a patient's risk of non-medical use of controlled substances as indicated by the PDMP report. While we continue to believe that practitioners should consult with their state's PDMP if they believe it appropriate to do so, we are not mandating the use of PDMPs at this time. We further note that our rule does not preempt or conflict with state laws that may require hospital consultation with PDMPs or other PDMP-related actions. We also refer readers to the discussion on PDMPs in section II.C of this final rule.

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. However, most commenters stated that the required timeframes were overly prescriptive and requested more flexibility pertaining to these timeframes. Several commenters noted the challenges that the lack of adoption of interoperable health IT among follow-up practitioners poses for hospitals. Two commenters requested that, instead of sending test results, hospitals instead be required to make such test results available or accessible to the follow-up practitioner(s). Two commenters felt that the timeframes included in the proposed rule were too flexible and that the required information should be sent to the practitioner(s) responsible for the follow-up care of the patient at the time of discharge to prevent any unnecessary delays in the patient's follow-up treatment.

Response:

We agree with the commenters that specific timeframe requirements may not be reasonable or appropriate in all situations. 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 further note that we are finalizing a requirement that hospitals and CAHs must discharge the patient, and 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 practitioners responsible for the patient's follow-up or ancillary care at § 482.43(b). We refer readers to section II.E.7 of this final rule for a more detailed discussion of this requirement.

We are not proposing a specific form, format, or methodology for the communication of this information; however, by using certified health IT, facilities can ensure that they are transmitting interoperable data that can be used by other settings, supporting a more robust care coordination and higher quality of care for patients. We note that HHS has a number of initiatives designed to encourage and support the adoption of health IT and to promote nationwide health information exchange to improve the quality of health care. 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 encourage hospitals and CAHs to find their own innovative and unique solutions to solve this issue, including any means that would ensure that these pending results are available and accessible to the appropriate facilities and practitioners at the appropriate time.

Comment:

Many comments were submitted regarding the requirement to provide discharge information to the practitioner(s) responsible for follow up care. One commenter stated that the list of information may be duplicative and, in some cases, excessive. The commenters added that for patients following up with their primary care provider, many of the preventive and baseline medical history items, as well as a psychosocial assessment, would already be known to the provider. Two commenters recommended that CMS require hospitals to provide the required necessary medical information, to dialysis facilities, dialysis units, or nephrologists within 48 hours of discharge. A few commenters questioned how the hospital would monitor the information sent by the hospital to the practitioner(s) responsible for follow-up care of the patient who is being discharged to their home.

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 this final rule, the hospital is now only required to provide certain necessary medical information that we believe allows a hospital the flexibility to effectively determine and align the pertinent patient information with a specific patient based on the clinical judgment of the practitioners responsible for the care of the patient since they are the practitioners who know the patient best while he or she is receiving care in the hospital. As many commenters noted, and with which we agree, a more flexible regulatory approach, such as we are finalizing here, allowing for the determination and transfer of a particular patient's necessary medical information will provide a more thoughtful and effective means to ensure better continuity of care for a patient being discharged. However this requirement as finalized in this rule will not limit the types and amount of patient information that can be shared with practitioners responsible for the patient's follow-up or ancillary care, but will also allow the inclusion of any additional clinically relevant information that the hospital's or CAH's practitioners believe would be beneficial for the patient's transition from one care setting to another.

Similarly, this requirement that a patient's necessary medical information must be transferred at the time of discharge (and transfer or referral as

applicable) 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. 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 note that we encourage providers to include any additional necessary medical information as part of the discharge summary as appropriate and also encourage them to ensure that any specific providers or suppliers or specialty practitioners that are clinically relevant to a particular patient be included in the conveyance of the necessary medical information upon discharge; for instance, when the hospital's health IT system is used to populate a discharge summary with relevant information from the patient's record. The hospital will not be responsible for monitoring information if it has been provided to the practitioner.

Further, we understand that there are special care needs for patients that are diagnosed with chronic illnesses such as kidney disease, diabetes, etc., and our requirements allow facilities to address and acknowledge these needs by sending a patient's necessary medical information to a special needs facility/provider such as a dialysis facility or nephrologist, if this information is known. However, we believe it would be burdensome to specifically mandate that facilities send this information to these providers and practitioners, or to prescribe a specific timeframe for sending the information. Instead, we are allowing facilities to have the flexibility to determine when and if this information should be sent. However, we must note here again that a patient's dialysis care plan information is part of his or her necessary medical information. We believe that this information should be conveyed upon discharge or transfer since such information is clearly necessary medical information and should be transferred with the patient. As for all requirements in this regulation, further implementation guidance will be provided. Furthermore, we believe that providing pertinent information such as specialized assessments and information regarding DME needs is a valuable piece of necessary medical information. We also expect that hospitals are providing any necessary requested information to follow up providers.

Comment:

One commenter stated that the discharge instructions should be provided to HHAs prior to or at the time of discharge when the patient is referred to home health services following discharge to home from the hospital. The commenter also suggested that in cases in which the patient was receiving home health services prior to the current hospitalization, hospitals should be required to maintain ongoing communications with the HHA. The commenter believes that the HHA that was providing services to the patient prior to the current hospital admission should continue to be the patient's PAC provider should the patient be referred for home health services following the current inpatient admission if the patient chooses.

Response:

While we have revised and relocated some of the proposed requirements in this final rule, we have essentially retained (with some clarifying modifications as well as the addition of some important elements of the proposed requirements for this section) the current requirement that the hospital must transfer or refer the patient, along with his or her necessary medical information, to appropriate facilities, agencies, or outpatient services, as needed, for follow-up or ancillary care upon discharge. We are finalizing the requirement as standard (b) “Discharge of the patient and provision and transmission of the patient's necessary medical information,” will require the hospital (or the CAH) to 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.

In this final rule, the patient must be referred to a Medicare-participating HHA that serves the geographic area (as defined by the HHA) in which the patient resides. It is expec

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