Proposed rule regarding Home Health and Conditions of Participation

Medicare and Medicaid Program: Conditions of Participation for Home Health Agencies

This proposed rule would revise the current conditions of participation (CoPs) that home health agencies (HHAs) must meet in order to participate in the Medicare and Medicaid programs. The proposed requirements would focus on the care delivered to patients by home health agencies, reflect an interdisciplinary view of patient care, allow home health agencies greater flexibility in meeting quality care standards, and eliminate unnecessary procedural requirements. These changes are an integral part of our overall effort to achieve broad-based, measurable improvements in the quality of care furnished through the Medicare and Medicaid programs, while at the same time eliminating unnecessary procedural burdens on providers.

To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on December 8, 2014.

Under our proposal, the HHA CoPs would continue to be set forth in regulations under 42 CFR part 484. However, since many of the current requirements in part 484 would be revised, consolidated with other requirements, or eliminated, this proposed rule would make extensive changes in the current organizational scheme. The most significant change would be grouping together all CoPs directly related to patient care and place them near the beginning of part 484. Regulations concerning the organization and administration of a HHA would follow in a separate subpart titled “Organizational Environment.” This format would be better in keeping with the patient-centered orientation of these regulations, and would reinforce our view that patient assessment, care planning, and quality assessment and performance improvement efforts are central to the delivery of high quality care.

B. Proposed Subpart A, General Provisions

We propose to reorganize this section to clarify the basis and scope of this part. Specifically, § 484.1 would set out the statutory authority for these regulations. Part 484 is based on sections 1861(o) and 1891 of the Act, which establish the conditions that a HHA must meet in order to participate in the Medicare program. Part 484 is also based on section 1861(z) of the Act, which specifies the institutional planning standards that HHAs must meet. These provisions serve as the basis for survey activities for the purposes of determining whether an agency meets the requirements for participation in Medicare. Currently, § 484.1(a)(3) refers to section 1895 of the Act, which serves as the basis for the establishment of a prospective payment system for home health services covered under Medicare. This section of the Act is already cited at § 484.200 as the basis for subpart E of this part, Prospective Payment System for Home Health Agencies, therefore, we propose to delete § 484.1(a)(3).

At § 484.2, we propose to clarify some of the definitions for terms used in the HHA CoPs. The definition for “branch office” would be modified by adding the requirement that the parent agency offer more than the sharing of services; specifically, that it provide supervision and administrative control of branches on a daily basis to the extent that the branch depends upon the parent agency's supervision and administrative functions in order to meet the CoPs, and could not do so as an independent entity. The supervision and administrative control would have to assure that the quality and scope of items and services provided was of the highest practicable level for all patients, so as to meet their medical, nursing, and rehabilitative needs. Though the definition would no longer require the branch office to be “sufficiently close,” the parent agency would have to be available to meet the needs of any situation and respond to issues that could arise with respect to patient care or administration of the agency. A violation of a CoP in one branch office would apply to the entire HHA.

We also propose minor changes in the language of the current definitions for “clinical note,” “parent home health agency,” “proprietary agency,” and “subdivision.” These changes would achieve greater clarity within these definitions and achieve consistency with the other definitions contained in this section.

We also propose to eliminate current definitions of the terms “bylaws” and “supervision.” We believe the meanings of these terms are self-evident, and would provide sub-regulatory guidance on them in the future, should there be a need for such guidance. We are proposing to eliminate the definition for “home health agency” because its definition is set out by statute at section 1861(o) of the Act. We propose to delete the term “progress notes” because notations in the clinical record and more typically referred to as “clinical notes,” a term that is well defined and understood in the HHA industry.

We propose to delete the term “subunit” because the distinction between the requirements that the parent HHA and a subunit must meet are minor. Currently, a subunit must be able, independently, to meet the CoPs. The distinction between a “subunit” of a HHA and an independent HHA is that a “subunit” may share the same governing body, administrator, and group of professional personnel with its parent HHA. In practice, the requirement that a “subunit” must independently meet the CoPs renders this distinction moot, and we believe that an entity operating for all intents and purposes as a distinct HHA should be treated as such. Therefore, upon finalization of this rule, existing subunits, which already operate under their own provider number, would be considered distinct HHAs and would be required to independently meet all CoPs without sharing a governing body or administrator. We propose to delete the requirements for the group of professional personnel; therefore it would no long matter if this group was shared among HHAs. Based on state-specific laws and regulations, this federal regulatory change would permit a subunit to apply to become a branch of its existing parent HHA if the parent provided “. . . direct support and administrative control” of the branch. The state survey agency and CMS Regional Office are responsible for approving a HHA's application for a branch office, in accordance with current CMS guidance as set out in various survey and certification lettersand section 2182.4B of the State Operations Manual. No new subunits would be approved upon implementation of this regulation, only “branch offices.”

Finally, we propose to add definitions for the terms “in advance,” “quality indicator,” “representative,” “supervised practical training,” and “verbal order.” We would add a definition for the term “quality indicator” because the use of quality indicators is central to a HHA's successful implementation of a quality assessment and performance improvement program. HHAs already have numerous quality indicators available to them through the OASIS. The OASIS data set provides empirical data to measure the quality of care a Medicare patient receives from an HHA, including care delivery, patient outcomes, and potentially avoidable events. The data are able to demonstrate trends across time. The OASIS data and the measures calculated from that data are indicators of quality that can be used for internal quality improvement efforts, in the survey process, and in the consumer decision-making process. However, the HHA quality indicators would not be limited to data gathered by the OASIS instrument or even measures calculated by CMS. HHAs may also identify quality indicators from outside sources such as research projects, collaborative QIO endeavors, and accrediting bodies, to name a few.

We propose to define the term “representative” in a patient-centered manner that enables patients to choose their representatives, if they wish to do so. We believe that the patient receiving services should be involved in the person-centered care planning process, and recognize that there are times when patients may want to involve other people in that process to assist in making decisions. Likewise, patients may also choose to designate another person to make all decisions on the patient's behalf. We believe that defining a “representative” in a manner that recognizes patient choice, both in who the representative is and in the role that the representative will play, would be beneficial to patients. We also propose to explicitly recognize legal guardians in situations where the patient has one. If a HHA has reason to believe that the representative is not acting in accordance with what the patient would want, is making decisions that could cause harm to the patient, or otherwise cannot perform the required functions of a representative, we would expect the HHA to make referrals and/or reports to the appropriate agencies and authorities to assure the health and safety of the patient.

We would define the term “verbal orders” to mean those physician orders that are delivered verbally (meaning spoken), by the physician, to a nurse or other qualified medical personnel, and recorded in the plan of care. “In advance” and “supervised practical training” would be defined to provide clarity for clinical care purposes.

As discussed in detail in section III.D.4 of this preamble, we are proposing modifications to the current personnel qualifications requirements. Therefore, we would not retain the provisions of current § 484.4, “Personnel qualifications,” under proposed subpart A, General Provisions. These modifications would be set forth under proposed § 484.80, “Home health aide services,” and proposed § 484.115, “Personnel qualifications.”Show citation box

We are also proposing to retain the current definitions of “primary home health agency,” “public agency,” and “summary report” without change.

Proposed Subpart B, Patient Care

1. Release of Patient Identifiable Outcome and Assessment Information Set (OASIS) Information (Proposed § 484.40)

At § 484.40, we propose to recodify the current requirements of § 484.11, which require an HHA and its agents to ensure the confidentiality of all patient-identifiable information in the clinical record, including the OASIS data.

2. Reporting OASIS Information (Proposed § 484.45)

In this CoP, we propose to include most of the current requirements of § 484.20, which relate to the electronic reporting of the OASIS data. We propose to replace the current requirement that an HHA transmit data using electronic communications software that provides a direct telephone connection from the HHA to the state agency or CMS OASIS contractor. This requirement does not reflect current technology; therefore, we believe that it is no longer appropriate. Instead, we propose to add a requirement that the OASIS data be transmitted in accordance with current CMS transmission policy, which currently requires HHAs to transmit data using electronic communications software that complies with the Federal Information Processing Standard (FIPS 140-2, issued May 25, 2001).

3. Patient Rights (Proposed § 484.50)

At § 484.50, we propose to re-designate and modify the patient rights provisions that are found at current § 484.10. Section 1891(a)(1) of the Act states a HHA must protect and promote the rights of each individual under its care. Currently, the patient rights provisions are organized into the following six standards: (1) Notice of rights; (2) Exercise of rights and respect for property and person; (3) Right to be informed and to participate in planning care and treatment; (4) Confidentiality of medical records; (5) Patient liability for payment; and (6) the Home Health hotline.

In this rule, we propose to reorganize patient rights under six standards: (1) Notice of rights; (2) Exercise of rights; (3) Rights of the patient; (4) Transfer and discharge; (5) Investigation of complaints; and (6) Accessibility. While the proposed patient rights provisions retain much of the basic focus of the current provisions, we believe our proposal presents a clearer and more organized view of our expectation of how HHAs should promote patient rights by focusing on ensuring patient safety and improving patient outcomes.

The current “Notice of rights” standard states only that the HHA must provide written notice of the patient's rights in advance of furnishing care, and that the HHA must maintain documentation demonstrating compliance. In proposed § 484.50(a), we state that each patient and patient representative (if the patient has one), has the right to be informed of his or her rights in a language and manner the individual understands. More specifically, under proposed § 484.50(a)(1), we propose that the HHA provide the patient and patient's representative with verbal notice of the patient's rights in the primary or preferred language of the patient or representative, and in a manner that the individual can understand, during the initial evaluation visit, and in advance of care being furnished by the HHA. The patient's representative, who could be a family member or friend who accompanies the patient, may act as a liaison between the patient and the HHA to help the patient communicate, understand, remember, and cope with the interactions that take place during the visit, and explain any instructions to the patient that are delivered by the HHA staff. The representative would not need to be the patient's legal representative.

If a patient is unable to effectively communicate directly with HHA staff, then the HHA may effectively communicate patient rights information to the patient's representative. Communications with the representative would be required to bein the representative's primary or preferred language and in a manner that he or she can understand. Whether communicating with a patient or representative, HHA staff would be required to provide language assistance services or auxiliary aids and services at no cost, and provide notice of the availability of assistance, when necessary, to ensure effective communication between patients, representatives, and HHA staff. We note that the requirement to provide assistance and aids already exists as part of relevant statutes (for example, Title VI of the Civil Rights Act of 1964) and the regulations that implement these statutes (see 45 CFR parts 480, 405, and 490), and that HHAs agree to abide by these regulations as part of the provider agreement that they sign in order to participate in Medicare (see 42 CFR part 489). Compliance with the existing statutes, regulations, and sub-regulatory guidance documents would satisfy the intent of this proposed provision.

If the patient or representative prefers using an interpreter of his or her own, he or she may do so. The HHA must ensure that the communication via the interpreter of choice is effective. HHAs may wish to document the offer and refusal of a professional interpreter in the patient's clinical record as evidence of compliance with the requirements of this section. A professional interpreter is not considered to be a patient's representative. Rather, it is the professional interpreter's role to pass information from the HHA to the patient.

We also propose to require that the patient be provided a written copy of the patient rights information. This could be provided in English or in the patient's primary or preferred language for present or future reference. The written information would be required to be provided in alternate formats free of charge for persons with disabilities, when necessary, to ensure effective communication. In addition, written notice would be required to be understandable to persons who have limited English proficiency. Furthermore, HHAs would be required to inform patients of the availability of the services and instruct patients how to access those services.

While we propose these requirements under the authority of sections 1861(o) and 1891 of the Act, Title VI of the Civil Rights Act of 1964 (42 U.S.C. 2000d et seq.) and Section 504 of the Rehabilitation Act of 1973 also apply to HHAs, as well as other health care providers. Our proposed requirement has been designed to be compatible with guidance related to title VI of the Civil Rights Act of 1964. The Department of Health and Human Services' (HHS) guidance related to Title VI, “Guidance to Federal Assistance Recipients Regarding Title VI Prohibition Against National Origin Discrimination Affecting Limited English Proficient Persons” (August 8, 2003, 68 FR 47311) applies to those entities that receive federal financial assistance from HHS, including HHAs that participate in Medicare and Medicaid. This guidance may assist HHAs in ensuring that patient rights information is provided in a language and manner the patient understands.

Proposed § 484.50(a)(2) would require the HHA to provide each patient with specific business contact information for the HHA's administrator so that patients and caregivers could report complaints and specific patient rights violations to the HHA administrator, and so that patients and caregivers can ask questions about the care being provided.

We are also proposing at § 484.50(a)(3) that the HHA provide a copy of the OASIS privacy notice to all patients from whom the OASIS data are collected at the same time that the general notice of rights is provided to the patient. The OASIS privacy notice would inform the patient why the OASIS information was being collected and describe the rights of the patient regarding the collection of this information. The OASIS privacy notice is available in English and Spanish, and can be found at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/OASIS/Regulations.html. Use of the OASIS Privacy Notice is required by the Federal Privacy Act of 1974, and must be used, in addition to other notices that may be required by other privacy laws and regulations. There is additional discussion of the use of the OASIS Privacy Notice in the Dec. 23, 2005 rule (70 FR 76199, 76201), where we referred to a variety of provisions governing the privacy and security of the Federal automated information systems.

Finally, at § 484.50(a)(4), we would require that the HHA obtain the patient's or representative's signature confirming that he or she has received a copy of the notice of rights and responsibilities.

The current standard at § 484.10(b) sets out requirements for the exercise of patient rights and respect for property and person as one standard. We have stressed the importance of these two individual concepts by proposing to separate the requirements into 2 standards at § 484.50(b), “Exercise of rights” and at § 484.50(c), “Rights of the patient.” Under proposed § 484.50(b), in the event that a patient was declared incompetent under state law by a court of proper jurisdiction, the rights of that patient could be exercised by the person appointed by the state Court. If a state court had not made a declaration, any representative, as chosen by the patient, could exercise the rights of the patient in accordance with the patient's preferences. In situations where a patient has been adjudged to lack legal capacity under state law by a court of proper jurisdiction, the patient would be allowed to exercise his or her rights to the extent allowed by the court order. We propose these provisions in recognition of the complexities of representation. There are many circumstances under which representatives may be used, and the extent of such representation varies from one patient to another. Some patients may require total representation because they are unable to communicate and advocate for themselves. Others may be able to participate in their care to a certain degree and require representation as a supportive mechanism. Still other patients may wish to hand off decision-making and advocacy responsibilities to another person even though these patients are fully capable of fulfilling this role themselves. Our goal is to provide guidance to HHAs regarding how to address these situations and intricacies in the most patient-centered, patient-directed way possible. We specifically seek public comment on ways to assure that patient choice is respected and upheld, while also balancing the need to assure patient safety.

Proposed § 484.50(c) would set forth the explicit rights of each home health patient. At § 484.50(c)(1), we propose that the patient would have a right to have his or her property and person treated with respect. At § 484.50(c)(2), we propose that the patient would have a right to be free from verbal, mental, sexual and physical abuse, including injuries of unknown source, neglect, and misappropriation of property. If an injury of unknown source is identified, we would expect the HHA to investigate the injury in order to determine its cause and take action to prevent further injuries related to that source. Under proposed § 484.50(c)(3), the patient would have a right to make complaints to the HHA regarding treatment or care that was (or failed to be) furnished which the patient and/or their family believe was inappropriate. Under proposed § 484.50(c)(4), patients and their representatives would also have the right to participate in, be informed about, and consent or refuse care.Moreover, each patient would have the right to participate in and be informed about the patient-specific comprehensive assessment, including an assessment of the patient's goals and care preferences. We expect that this assessment would focus on goals and preferences that are specific to the delivery of home health care. Additionally, each patient would have the right to participate in and be informed about the care that the HHA will furnish based on the needs identified during the comprehensive assessment, establishing and revising that plan, the disciplines that will furnish care, the frequency of visits, identifying expected outcomes of care, and any factors that could impact treatment effectiveness. In accordance with proposed § 484.50(c)(4)(iii), each patient would also have the right to receive a copy of his or her individualized HHA plan of care to be kept in his or her home, including all updated plans of care, as described in proposed § 484.60. HHAs would be required at § 484.50(c)(4)(viii) to inform the patient about any changes in the care to be furnished in advance of those changes being made in the patient's plan of care. In addition to being involved in the care planning process, we would add a requirement at § 484.50(c)(5) that patients have the right to receive all of the services outlined in the plan of care. Additionally, we propose to retain the current requirements from current § 484.10(d), which concern the patient's right to the confidentiality of his or her clinical records, under proposed § 484.50(c)(6). In order to maintain confidentiality within the patient's home, as we are proposing at § 484.50(c)(4)(iii), we would expect an HHA to educate a patient and family about how to store the copy of the patient's plan of care in the patient's home.

Proposed § 484.50(c)(7), would retain the requirements of the current standard at § 484.10(e), Patient liability for payment. Patients would be informed about which services would be covered, which services might or might not be covered, and the patient's liability for payment. This patient liability requirement would be related to the home health advance beneficiary notice (ABN) and home health change of care notices; therefore, we propose to reference the current requirements at § 411.408(d)(2) and § 411.408(f). HHAs would be required to comply with all ABN requirements, including restrictions related to who may receive the ABN on the patient's behalf.

In accordance with the requirements of the Medicare provider agreement, HHAs must not discriminate against Medicare beneficiaries, and if a participating HHA accepts non-Medicare patients at any given level of acuity, it must also accept Medicare beneficiaries at a similar level of acuity as a condition of participating in the Medicare program. HHAs that provide services to non-Medicare patients while refusing services to Medicare patients in similar situations risk having their provider agreements terminated, in accordance with § 489.53(a)(2).

At proposed § 484.50(c)(8), we would retain the basic concept of the requirement at current § 484.10(e) regarding patient payment liabilities. A patient would have the right to receive proper written notice, in advance of a specific service being furnished, if the HHA believes that the service may be non-covered care; or in advance of the HHA reducing or terminating on-going care. We propose to revise this current requirement by cross-referencing the regulations regarding expedited reviews, found at 42 CFR part 405, subpart J. These requirements protect patients from unexpected bills for usually covered care, which may not be covered by Medicare in a particular instance, and ensures patient access to the expedited review process.

We would retain the current standard found at § 484.10(f), regarding the home health hotline at proposed § 484.50(c)(9). The home health hotline provides an important avenue for patients to register complaints against, or pose questions about, an HHA. Patients would still retain the right to be informed of the availability of the toll-free home health hotline in their state, including the telephone number and the hours of operation. The patients would be advised that the purpose of the hotline was to receive complaints or questions about local HHAs. Additionally, under § 484.50(c)(10), patients would be advised of the names, addresses, and telephone numbers for relevant Federally and State-funded consumer information, consumer protection, and advocacy agencies. HHAs should select agencies that have a public service mission and provide assistance free of charge, such as area Agencies on Aging, Aging and Disability Resource Centers, legal service programs, State Health Insurance Programs, and Adult Protective Services. HHAs would have the discretion to select, for inclusion in the list, those local agencies and organizations that are likely to be most appropriate for the needs of each HHA's unique patient population.

We also propose at § 484.50(c)(11), that patients have the right to be free from discrimination or reprisal for exercising their rights, whether by voicing grievances to the HHA or to an outside entity, such as those advocacy and protection agencies described above. Examples of discrimination or reprisal may include a reduction of current services or a complete discontinuation of services and discharge from the HHA.

Finally, we propose at § 484.50(c)(12) that patients have the right to be informed of their right to access auxiliary aids and language services, and to be provided instruction on how to access these services. We believe that making auxiliary aids and language services available to patients, to facilitate an understanding of their rights and to facilitate the provision of care throughout the care planning and care delivery process will improve the quality and effectiveness of the care that is delivered, and will improve the patient's experience of care as a whole.

We propose to add a new standard at § 484.50(d), which would mandate that all patients and representatives (if any), have the right to be informed of the HHA's policies governing admission, transfer, and discharge. This proposed standard would list the criteria by which an HHA could discharge or transfer a patient. The proposed criteria are designed to help prevent the untimely discharge of home health patients and ensure that patients are discharged or transferred only under appropriate circumstances. This proposed standard would require that the HHA inform its patients of its policies governing admission, transfer, and discharge in advance of the HHA providing care. Under this proposed standard, an HHA could only transfer, discharge, or terminate care for the following reasons: (1) When the HHA could no longer meet the patient's needs, based on the patient's acuity; (2) when the patient or payer could no longer pay for the services provided by the HHA; (3) when the physician and HHA agreed that the patient no longer needed HHA services because the patient's health and safety had improved or stabilized sufficiently; (4) when the patient refused HHA services or otherwise elected to be transferred or discharged (including if the patient elected the Medicare hospice benefit); (5) when there was cause; (6) when a patient died; or (7) when the HHA ceased to operate.

In accordance with the requirements of proposed § 484.50(d)(1), if the care needs of a patient exceeded the HHA's ability to provide services, the HHAwould be required to ensure that the patient received a safe and appropriate transfer to another care entity better suited to meeting the patient's needs. There are no regulations in the current CoPs that address these issues. However, this provision is consistent with the decision in Lutwin v. Thompson 361 F.3d 146 (2nd Cir. 2004) regarding the provision of notice when services are reduced or terminated.

Likewise, although current CMS guidance (100, Chapter 7, Section 10.10, Discharge Issues) allows discharge for cause, there are no regulations in the current CoPs that address these issues. We are proposing to add § 484.50(d)(5) to permit discharge for cause if the patient's (or other persons in the patient's home) behavior is so disruptive, abusive, or uncooperative that the delivery of care to the patient or the ability of the HHA to operate effectively and safely is seriously impaired. Before discharging a patient for cause, the HHA would be required to advise the patient, the representative (if any), the physician who is responsible for the home health plan of care, and the patient's primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) that a discharge for cause was being considered, make efforts to resolve the problem(s) presented by the patient's behavior or by other person(s) in the home (as applicable), or situation (such as a dangerous animal being loose in the home), document the problem(s) and efforts made to resolve the problem(s), and enter this documentation into its clinical records. Additionally, we propose that the HHA would be required to provide the patient and representative (if any), with contact information for other agencies or providers who may be able to provide care following the discharge. It would be incumbent upon the HHA to take all reasonable steps to resolve safety and noncompliance issues prior to taking steps to discharge a patient.

Given the vulnerability of home health patients and in the interest of patient safety, we propose a standard at § 484.50(e), “Investigation of complaints,” that would expand upon the current complaint investigation requirements at § 484.10(b)(5). Proposed § 484.50(e)(1)(i) would require the HHA to investigate complaints made by patients, representatives, caregivers, and families regarding treatment or care that is (or fails to be) furnished, is furnished inconsistently, or is furnished inappropriately. In addition, HHAs would be required to investigate allegations of mistreatment, neglect, or verbal, mental, psychosocial, sexual, and physical abuse, including injuries of unknown source, and/or misappropriation of patient property by anyone furnishing services on behalf of the HHA. This requirement would clarify that all patient complaints should be investigated by HHAs. Proposed § 484.50(e)(1)(ii) would require the HHA to document both the existence and the resolution of the complaint, while § 484.50(e)(1)(iii) would require the HHA to take immediate action to prevent further potential abuse while the complaint was being investigated. We believe that HHAs should be permitted the flexibility to establish their own policies and procedures for documenting and resolving complaints, and we would expect HHAs to consistently adhere to these policies and procedures.

Proposed § 484.50(e)(2) would require any HHA staff, regardless of whether they are employed directly or obtained under arrangements with another entity, to immediately report to the HHA administrator or other appropriate authorities any incidences of mistreatment, neglect, or abuse, and/or any misappropriation of patient property, which they have noticed during the normal course of providing services to patients. Since HHA staff is in a unique position to recognize signs of patient abuse in the home, this proposed requirement would serve to further ensure the health and safety of home health patients. “Appropriate authorities” may include, but are not limited to, state and local law enforcement, health care ombudsmen, and State survey agencies.

To address effective communication with patients who are LEP or have disabilities, we are proposing a new standard at § 484.50(f), “Accessibility.” We propose that information that is provided to patients would be provided in plain language, and in a manner that is both accessible and timely to the individual. For people with disabilities, providing access includes the use of accessible Web sites and the provision of auxiliary aids and services, such as qualified interpreters and alternate formats. For persons with LEP, providing access includes providing oral interpretation and written translations.

4. Comprehensive Assessment of Patients (Proposed § 484.55)

We propose to retain the majority of the substantive requirements of current § 484.55, with significant reorganization. We propose to retain the requirement that each patient be required to receive a patient-specific comprehensive assessment. We also propose to retain the requirement that, for Medicare beneficiaries, the HHA would be required to verify the patient's eligibility for the Medicare home health benefit, including the patient's homebound status, at the specified timeframes. Furthermore, we propose to retain all requirements related to the initial assessment visit at standard (a), as well as the completion of the comprehensive assessment requirements at standard (b).

We propose to establish a new standard (c), “Content of the comprehensive assessment,” that would incorporate much of the content currently set forth in the introductory paragraph of the CoP, the drug regimen review currently set forth in standard (c), and the incorporation of the OASIS data items requirement currently set forth at standard (e). We also propose new content requirements, such as an assessment of psychosocial and cognitive status, which we believe would provide for a more holistic patient assessment. We propose to require that the comprehensive assessment must accurately reflect the patient's status, and would assess or identify (as applicable) the following:

• The patient's current health, psychosocial, functional, and cognitive status;
• The patient's strengths, goals, and care preferences, including the patient's progress toward achievement of the goals identified by the patient and the measurable outcomes identified by the HHA;
• The patient's continuing need for home care;
• The patient's medical, nursing, rehabilitative, social, and discharge planning needs;
• A review of all medications the patient is currently using;
• The patient's primary caregiver(s), if any, and other available supports; and
• The patient's representative (if any).

The assessment would also be required to incorporate items from the information collection set out in the OASIS data set, using the language and groupings of the OASIS items, as specified by the Secretary.

We propose to retain the majority of the content of the requirements of current § 484.55(d), with one change. Currently § 418.55(d)(2) generally requires that an update of the comprehensive assessment must be completed within 48 hours of a patient returning home after a hospital admission. This fixed requirement does not allow ordering physicians to modify the time frame for the HHA to resumeits care. We believe that it is in the best interest of patients to allow for more physician discretion so that physicians can tailor the resumption of home health care to the specific needs of a patient. Therefore, we propose to revise § 484.55(d)(2) to allow for a physician-ordered resumption of care date as an alternative to the fixed 48 hour time frame.

5. Care planning, Coordination of Services, and Quality of Care (Proposed § 484.60)

Current regulations concerning the plan of care are set forth at § 484.18, “Acceptance of patients, plan of care, and medical supervision.” We propose to revise that requirement, as well as current § 484.14(g), “Coordination of patient services,” by creating a new condition of participation, “Care planning, coordination of services, and quality of care” at § 484.60. This section would specify that the HHA would have to provide the patient a plan of care that would set out the care and services necessary to meet the patient-specific needs identified in the comprehensive assessment, and the outcomes that the HHA anticipates would occur as a result of developing the individualized plan of care and subsequently implementing its elements. We propose five standards under this CoP, which we believe reflect and encourage the interdisciplinary approach to home health care delivery. We would reorganize the current standards to place the events in the care planning process in sequential order: (1) Plan of care at § 484.60(a); (2) conformance with physician orders at § 484.60(b); (3) review and revision of the plan of care at § 484.60(c); (4) coordination of care at § 484.60(d); and (5) discharge or transfer summary at § 484.60(e).

In this CoP, we propose to require that patients be accepted for treatment on the basis of a reasonable expectation that the patient's medical, nursing, rehabilitative, and social needs could be met adequately by the agency in the patient's place of residence. Each patient would receive an individualized written plan of care which would specify the care and services necessary to meet the patient's needs, including the patient and caregiver education and training that the HHA will provide, specific to the patient's care needs. A copy of this individualized plan would be provided to each patient and representative (if any), in accordance with the proposed patient rights requirements at § 484.50(c)(4)(iii). We believe that providing each patient with a copy of his or her plan of care will improve HHA-patient communications and enable patients to more thoroughly understand the care that they are to receive. We also believe that part of providing this information is teaching patients and their families how to protect the information in order to ensure their right to a confidential record, as would be required in proposed § 484.50(c)(6). The individualized plan of care would be revised or added to at intervals as necessary to continue to meet patient care needs.

We also propose that the plan of care include the patient-specific measurable outcomes which the HHA anticipates would result from its implementation. As described in proposed § 484.50(c)(4), the patient has the right to participate in his or her care planning, including the establishment of goals and outcomes of care. We would expect the plan of care to be reflective of the improvement, maintenance, and/or prevention goals and outcomes specific to each patient's condition. As noted in a recent update to the Medicare Benefit Policy Manual (CR 8458, http://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R179BP.pdf), consistent with the settlement agreement in the case of Jimmo v. Sebelius, maintenance of the patient's current condition and prevention or slowing of further deterioration of the patient's condition may both warrant the use of skilled care provided under the Medicare home health benefit. All services furnished by the HHA for all purposes would be provided in accordance with accepted standards of practice.

Under proposed § 484.60(a)(1), Plan of care, we propose that all home health services furnished to patients would follow an individualized written plan of care, setting out, among other things, the frequency and duration of therapeutic interventions. The plan would be established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatric medicine acting within the boundaries of all applicable state laws and regulations. An evidence and outcome-based approach to patient care that can be understood by the patient and caregivers, with specificity of orders and adherence to best practice interventions, would provide a basis for the development of the optimal plan of care and goals. Patients participating in the shared decision-making model, where there is a mutually respectful exchange that recognizes the individuality of the patient and a process in which responsibility is divided among the patient, physician, and agency acting on physician orders, will better understand the goals of treatment. These patients are more likely to actively participate in the treatment process and achieve better treatment outcomes. (“A typology of preferences for participation in healthcare decision making,”http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1637042) The shared decision making model has been embraced in literature (“Decision-making in the physician-patient encounter: revisiting the shared treatment decision-making model”, http://www.sciencedirect.com/science/article/pii/S0277953699001458;“Four Models of the Physician-Patient Relationship,” JAMA (1992).; “Physician Recommendations and Patient Autonomy: Finding a Balance between Physician Power and Patient Choice,”http://annals.org/article.aspx?articleid=710110), and the Institute of Medicine has recommended including it in medical school curricula as a mechanism to improve care (Institute of Medicine, “Improving Medical Education: Enhancing the Behavioral and Social Science Content of Medical School Curricula” (2004)) (See alsobrown.edu/.../Mod2SharedDecMaking/Teachingmats/Handout1SDMDefined.doc). This standard would require that each patient's home health services be furnished under a written, patient-specific plan of care that would identify patient-specific measurable outcomes and goals selected jointly by the HHA and the patient.

We are soliciting public comments regarding methods to engage patients and the physicians who are responsible for their plans of care in the care planning and management process. Specifically, we are interested in ways to maximize the level of involvement of the physician who is most involved in the patient's care prior to admission to the home health agency, and who is responsible for overall treatment of the condition(s) that led to the need for home health care. We believe that the continual involvement of physicians may facilitate better transitions of care, improve patient outcomes, and reduce acute care admissions by clearly establishing (and updating) treatment goals and plans, and effectively delivering care that meets those goals. We are also interested in ways to facilitate communication between the HHA and other physicians and practitioners (such as nurse practitioners and physician assistants) who may be furnishing care for issues that are not directly connected to the issues being addressed by the HHA. Additionally, we are interested in waysto facilitate communication with those physicians and practitioners who will be responsible for managing the patient's care after the patient is discharged from the HHA. We believe that actively soliciting input from these clinicians may help improve the transitions into and out of home health care.

The individualized plan of care would be required to include all pertinent diagnoses; the patient's mental, psychosocial, and cognitive status; the types of services, supplies, and equipment required; the frequency and duration of visits to be made; prognosis; rehabilitation potential; functional limitations; activities permitted; nutritional requirements; all medications and treatments; safety measures to protect against injury; patient and caregiver education and training to facilitate timely discharge or referral; patient-specific measurable outcomes/goals; and any additional interventions/orders the HHA or physician chose to include. We note that it is important for HHAs to consider the social determinants that may contribute to poor health outcomes, as many current approaches to prevention, treatment, and disease control are limited to an individual's diagnosis and related risk factors. There is often a lack of awareness and/or assessment of the factors that may enhance or create a barrier to good health outcomes. Factors such as low income, lack of access to a primary care practitioner, poor nutrition due either to poor choices and/or lack of availability of healthy and affordable food items (for example, “food deserts”), and other environmental, social, and/or emotional issues may affect compliance and/or adherence with medical care and treatment. The HHA staff must be aware of the social and/or economic circumstances in which people are born, grow up, live, work, and age, as well as what are in place for their overall health care. This contributes to the HHAs ability to identify state, local, and/or federal resources the patient may need in order to design a holistic plan of care that may result in improved health outcomes, care, and treatment results. For example, if an elderly, low income, insulin dependent diabetic patient is not able to afford regular meals, the home health agency staff may refer to local resources such as a food bank, meals on wheels, or other resource. Diabetic patients must have regular meals for blood sugar control. Lack of awareness and intervention related to this factor may result in a poor outcome for the patient. The Underserved Populations (UP) Network provides resources, tools, and webinars for agencies via http://www.homehealthquality.org/UP.aspxfocused on improving outcomes.

In order to implement the individualized physician-prescribed plan of care, agencies often develop a discipline-oriented plan, wherein each specific service being provided (for example, physical therapy, occupational therapy, and speech-language pathology) sets out findings, treatment goals, and interventions planned in order to achieve those goals in compliance with the physician's orders.

If HHA services are initiated following a patient's hospital discharge, we propose to require that the HHA must include an assessment of the patient's level of risk for hospital emergency department visits and hospital re-admission. In order to establish the patient's risk level, we believe that HHAs would identify the patient's specific risk factors. We propose that HHAs would be required to include in the patient's individualized plan of care all appropriate interventions that are necessary to address and mitigate those identified risk factors that contribute to the HHA's establishment of a particular risk level for a patient. Resources to assist HHAs in assessing re-hospitalization risks are available at http://www.homehealthquality.org.

Proposed § 484.60(b), “Conformance with physician orders,” would provide that drugs, services, and treatments be administered only as ordered by the physician who is responsible for the home health plan of care, a requirement that is currently set forth at § 484.18(c). This proposed standard also would reflect the vaccination policies of the final rule with comment period published in the Federal Register on October 2, 2002 (67 FR 61808), also set forth at § 484.18(c). That rule provided an exception from the physician order requirement for the administration of influenza and pneumococcal polysaccharide vaccines. The current requirement allows influenza and pneumococcal polysaccharide vaccines to be administered based on a HHA policy developed in consultation with a physician, and after an assessment for contraindications. We propose to retain this requirement at § 484.60(b)(2). Proposed § 484.60(b)(4) would maintain the requirement that only personnel authorized by applicable state laws and regulations and the HHA's internal policies, may accept verbal orders from physicians. We would maintain the intent of the current requirement at § 484.18(c) by proposing at § 484.60(b)(5) that a registered nurse (RN) or other qualified practitioner who is licensed to practice by the state must document the order in writing in the patient's clinical record, with a signature, time, and date. As described in the definitions section, for purposes of this rule, verbal orders are those physician orders that are spoken to qualified medical personnel. Verbal orders would also have to be recorded in the patient's plan of care. Reliance on a HHA to maintain physician orders in written form would protect patients by ensuring that the plan of care incorporated all services and treatments ordered by the physician who is responsible for the home health plan of care. If a physician faxed orders or otherwise transmitted them through other electronic methods from his or her office, those orders would be required to be included in the patient's clinical record and plan of care. The proposed rule would provide an opportunity for an HHA to establish policies defining who is authorized to accept physicians' verbal orders. The categories of practitioners identified as being authorized to accept physicians' verbal orders by the HHA would be required to be consistent with state requirements.

We would also require, under proposed § 484.60(b)(5), that verbal orders be authenticated, dated, and timed by the physician according to the HHA's internal policies and applicable state laws and regulations. Many states in their licensure requirements, and HHAs in their policies, have established timeframes for physician countersignature of verbal orders in accordance with the agency's risk tolerance, legal liability, and logistical concerns. Although timeframes may vary, we support state requirements and HHA flexibility in this regard, and do not propose a separate timeframe requirement for physician countersignature for verbal orders for HHA providers. In addition to all applicable state requirements and agency policies, HHAs should also be aware of CMS payment reimbursement requirements, which state that a final claim for each episode of care may not be submitted until all orders are signed.

Under proposed § 484.60(c), “Review and revision of the plan of care,” we propose that the individualized plan of care be reviewed and revised by the physician who is responsible for the HHA plan of care and the HHA as frequently as the patient's condition or needs requires, but no less frequently than once every 60 days, beginning with the start of care date. While the provision would require review and revision at least every 60 days, weexpect that physicians and agency staff would communicate more frequently if a patient's condition warranted it. To ensure patient health and safety, we propose that the HHA promptly alert the physician who is responsible for the HHA plan of care to any changes in the patient's condition or needs that would suggest that measurable outcomes are not being achieved and/or that the HHA should alter the plan. At § 484.60(c)(2), we propose to require that the HHA revise the plan of care, as necessary, to reflect current information from the patient's updated comprehensive assessment, and to record the patient's progress towards meeting the patient-specific measurable outcomes and goals selected by the HHA and patient, as specified in the plan of care. It would be the HHA's responsibility to make certain that all aspects of the revised plan of care were implemented.

Furthermore, we propose that it would be the HHA's responsibility to notify the patient, representative (if any), caregivers, and the physician who is responsible for the HHA plan of care, when the individualized plan of care is updated due to a significant change in the patient's health status. We also propose that, when the HHA makes updates related to plans for the patient's discharge, the HHA would communicate these changes with the patient and representative, caregivers, the physician who is responsible for the HHA plan of care, and the patient's primary care practitioner or other health care professional who will be responsible for providing care and services (if any) to the patient after discharge from the HHA. We believe that communicating with the patient and those who will be continuing to furnish services to the patient after home health services are discontinued regarding changes related to plans for discharge prior to the discharge would allow time for important discussions, preparations, and coordination activities. We note that the patient's primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA may be a specialist, a nurse practitioner, a physician assistant, or another type of medical service. In proposed § 484.60(d), “Coordination of care,” we propose to require that the HHA must integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness, the coordination of care provided by all disciplines, and communication with the physician. The proposed standard at § 484.60(d)(2) would also require the HHA to coordinate care delivery to meet each patient's needs, and to involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. It is our goal to support and foster collaboration and communication among the professional disciplines responsible for caring for a patient. It would be the agency's responsibility to determine the degree of coordination necessary to meet the needs of the patient, and to develop an approach that best implemented the coordination of the patient's care. It would also be the agency's responsibility to determine the most appropriate and effective way to provide evidence during a survey that these care coordination activities were occurring on a continual basis for every patient, and that the agency was assessing the impact of care coordination activities on patient care utilizing the HHA's quality assessment and performance improvement program, if appropriate.

Finally, under proposed § 484.60(d)(3), we propose that the HHA ensure that each patient and caregiver, where applicable, receive ongoing training and education from the HHA regarding the care and services identified in the plan of care that the patient and caregiver are expected to implement. This proposed requirement is consistent with those in the current payment-related regulations at § 409.42(c)(1). Ongoing patient training and education includes all periods of time that the patient is receiving care from an HHA, from admission through the day of discharge. The training would include educating the patient about his or her post HHA discharge care duties and the need (as appropriate) to follow-up with the patient's primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA. The HHA would be required to ensure that each patient and caregiver receives any training necessary to achieve the patient-specific measurable outcomes outlined in the plan of care, which are necessary for a timely discharge from the HHA. Each skilled professional would be expected to be responsible for educating the patient and/or caregiver about the care and services as appropriate to the discipline.

Under Medicare's home health benefit, when applicable, HHAs are expected to provide education and training to their patients. For instance, HHAs are expected to provide education and training to help insulin dependent diabetes mellitus (IDDM) patients and other diabetic patients self-manage their diabetes. Many homebound patients with diabetes require short-term management for skilled observation, assessment, teaching, and training activities. If the patient is unable to learn to self-manage, including self-administer medication, the HHA would be expected to provide the teaching and training to a care-giver or family member. We also encourage HHAs to take advantage of the help and support available from organizations that teach innovative techniques associated with diabetes self-management training (DSMT). Collaborating with these organizations may allow HHAs to achieve greater success in enabling patients and/or their caregivers to better achieve self-management, and may provide the HHAs with innovative care suggestions regarding their patients.

At § 484.60(e), Discharge or transfer summary, we propose that HHAs would compile a discharge or transfer summary for each discharged or transferred patient. The summary would be required to include the following:

• The initial reason for referral to the HHA,
• A brief description of the patient's HHA care,
• A description of the patient's clinical, mental, psychosocial, cognitive, and functional status at the start of care,
• A list of all services provided by the HHA to the patient,
• The start and end dates of HHA care,
• A description of the patient's clinical, mental, psychosocial, cognitive, and functional status at the end of care,
• The patient's most recent drug profile,
• Any recommendations for follow-up care,
• The patient's current individualized plan of care, and
• Any additional documentation that will assist in post-discharge or transfer continuity of care, or that is requested by the receiving practitioner or facility.

We propose to include these elements in the discharge or transfer summary to provide the clear and comprehensive summary that is necessary for effective and efficient follow-up care planning and implementation as the patient transitions from HHA services to another appropriate health care setting.

6. Quality Assessment and Performance Improvement (QAPI) (Proposed § 484.65)

Beginning with the 1999 Institute of Medicine (IOM) report entitled “To Err is Human: Building a Safer Health System,” the focus in health care changed from an incident-based, after-the-fact quality improvement focus to a pre-emptive, proactive quality assessment and performance improvement focus. CMS evaluated and responded to the recommendations in the IOM report through a coordinated effort called, “Doing What Counts for Patient Safety: Federal Actions to Reduce Medical Errors and Their Impact.” As part of our effort to reduce medical errors, and improve the quality of health care in all settings, we propose to replace two current HHA CoPs, § 484.16, “Group of professional personnel,” and § 484.52, “Evaluation of the agency's program,” with a single, new CoP, at § 484.65, “Quality Assessment and Performance Improvement” (QAPI). Overall, this proposed QAPI CoP is consistent with the QAPI program requirements for end stage renal disease facilities (§ 494.110), hospitals (§ 482.21), hospices (§ 418.58), organ procurement organizations (§ 486.348), and transplant centers (§ 482.96).

We believe that the proposed QAPI CoP would provide an opportunity for HHAs to develop a program that would enable them to identify areas for improvement which would help to ensure quality care and patient safety. In addition, we are emphasizing that the HHA would be required to take actions to prevent and reduce medical errors as part of their overall QAPI program. We have organized this new CoP into the following five standards: (1) Program scope; (2) Program data; (3) Program activities; (4) Performance improvement projects; and (5) Executive responsibilities.

The current CoPs rely on a problem-oriented, external, after the fact (occurrence) approach to resolve patient care issues. The proposed QAPI CoP would require proactive performance monitoring through an effective, ongoing, agency-wide, data-driven QAPI program that is under the supervision of the home health agency governing body.

In proposed § 484.65(a), “Program scope,” we propose that this data-driven QAPI program would be capable of showing measurable improvement in indicators for which there was evidence that the improvement led to improved health outcomes (for example, reduced hospitalizations and readmissions), safety, and quality of care for patients. The HHA would also have to measure, analyze, and track quality indicators, including adverse patient events, as well as other indicators of performance so that the agency could adequately assess its processes, services, and operations.

We propose, at § 484.65(b), “Program data,” that a HHA's QAPI program utilize quality indicator data, including measures derived from the OASIS (CMS provided reports), where applicable, and other relevant data, to assess the quality of care provided to patients, and identify and prioritize opportunities for improvement. Quality assessment efforts, including data collection, should focus on high priority safety and health conditions, and other goals identified by a HHA. The tools, collected data, and associated quality measures would be used by the HHA to monitor the effectiveness and safety of its services, as well as the quality of its care. In addition, the HHA would use the quality measures that are calculated based on the data collected to identify opportunities for improvement. We also propose that the HHA's governing body would be responsible for approving the frequency of, and level of detail to be used in data collection. This level of flexibility would allow HHAs to establish data collection and analysis policies and procedures that reflect currently accepted standards and practices.

At § 484.65(c), Program Activities, we would require a HHA's QAPI program activities to focus on high risk, high volume, or problem-prone areas of service, and to consider the incidence, prevalence, and severity of problems in those areas. We also propose that the HHA immediately correct any identified problems that directly or potentially threaten the health and safety of patients. Additionally, the HHA's QAPI activities would have to track incidents and adverse patient events, as well as analyze those events, so that preventive actions and mechanisms could be implemented by the HHA. We also propose that after steps have been taken to improve an area of concern, the HHA would continue to monitor the area in order to assure that improvements were sustained over time.

Proposed § 484.65(d), Performance improvement projects, would require that the HHA's performance improvement projects, conducted at least annually, reflect the scope, complexity, and past performance of the HHA's services and operations. An agency would need to focus on those areas of past performance which have proven to be problematic for the HHA over time or areas where there was clear evidence of poor patient outcomes, as well as areas of high-risk and high-volume. High-risk and high-volume areas will vary based on a HHA's patient population and other unique characteristics. For example, wound care could be a high-risk area for a HHA because the HHA does not perform the care very often, and thus may not be up-to-date on the latest techniques. Likewise, wound care could be a high-volume area for another HHA with a large number of patients requiring wound care services, increasing the likelihood of a problem occurring due to the sheer number of wound care visits that would occur. Data gathered either through the OASIS data set or through other measurement data collection tools, and subsequent analysis of the data, would be used to identify these areas. Within this standard, we also propose that the HHA document the QAPI projects undertaken, the reasons for conducting these projects, and the measurable progress achieved.

Finally, under proposed § 484.65(e), “Executive responsibilities,” we would require that the HHA's governing body assume responsibility for the agency's QAPI program. This subsection would require that the governing body assume the overall responsibility for ensuring that the QAPI program reflected the complexity of the HHA and its services, involved all services (including those provided under contract or arrangement), focused on indicators related to improved outcomes, and took actions that addressed the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. In the opening paragraph of § 484.65 we also propose to require the HHA to maintain documentary evidence of its QAPI program and to demonstrate its operation to CMS during the survey process.

The governing body would be required to define, implement, and maintain a program for quality improvement and patient safety that was ongoing and agency-wide. The governing body would be required not only to ensure that performance improvement efforts were prioritized, but that they were also evaluated for effectiveness. We note that it is the governing body which would be ultimately responsible for establishing the HHA's expectations for patient safety through an agency-wide QAPI program. Therefore, we propose that the governing body establish clear expectations for patient safety. We also propose that the governing body would appropriately address any findings of fraud or waste in order to assure thatresources are appropriately used for patient care activities and that patients are receiving the right care to meet their needs.

We believe small and mid-size HHAs would be able to effectively implement this condition as easily as larger HHAs. The proposed QAPI CoP would provide HHAs with enough flexibility to implement the quality assessment and performance improvement process without inordinate expenditure of capital or human resources. An HHA could also use outside resources to assist in development and support of its QAPI program. Each HHA's QAPI program should be individualized to reflect the size, scope, and complexity of its services and patient population. Therefore, we do not believe there is a need to differentiate our expectations for QAPI between small-to-mid-size HHAs and larger HHAs.

We have also chosen not to be prescriptive in this requirement because every HHA is different, and mandating “a one-size-fits-all,” process-oriented quality assessment and performance improvement program would not be beneficial to the patients or the HHA. Each HHA would be expected to conduct its QAPI program in a way that best meets its needs and the needs of that HHA's patients. HHAs would be able to utilize data from the OASIS data set through the risk-adjusted outcome-based quality improvement (OBQI), outcome-based quality management (OBQM), and process based quality improvement (PBQI) reports. Case-mix-adjusted outcome reports give agencies a “snapshot” of their individual agency's performance. The OASIS data set provides much of the necessary data items for CMS and HHAs to measure outcomes, potentially avoidable events, and patient/agency risk adjustment factors and for CMS to generate OBQI, OBQM, and PBQI reports. (The Outcome-Based Quality Improvement (OBQI) Manual (September 2002) and CASPER Reporting Application are located in the download section of CMS' HHQI OASIS OBQI Web page at http://www.cms.gov/HomeHealthQualityInits/16_HHQIOASISOBQI.asp#TopOfPage and http://www.cms.gov/HomeHealthQualityInits/18_HHQIOASISOBQM.asp#TopOfPage. The PBQI Manual (May 2010) is located in the “downloads” section of CMS'OASIS PBQI/Process Measures Web page section at http://www.cms.gov/HomeHealthQualityInits/15_PBQIProcessMeasures.asp#TopOfPage). The OBQI, OBQM, and PBQI reports can be used to assess the quality of care at HHAs and provide information to assist them in ongoing quality improvement.

In addition to these resources, there are other existing resources already in place through http://www.homehealthquality.org that support issues addressed in this proposed CoP. The Home Health Quality Initiative (HHQI) is part of the Quality Improvement Organization program established by CMS. Established in 2007, its goal is to improve the quality of home care services patients receive as measured by improvement in selected publicly reported and other clinical measures. Participation in the HHQI is free to all Medicare-participating HHAs. Participating HHAs have access to many resources that may aide in their QAPI efforts, such as best practice intervention packages that offer practical applications of quality improvement strategies to improve performance, individualized data reports via a secure online portal to assist with measuring progress, networking and educational opportunities via webinars scheduled at least monthly, and prompt assistance to address needs and questions. In particular, the HHQI provides resources related to falls prevention, flu and pneumonia vaccinations, oral medication management, and patient self-management.

Through the survey process, we intend to assess whether HHAs have all of the components of a QAPI program in place. Surveyors would expect HHAs to demonstrate, with the objective data from the OASIS data set and other sources available to the HHA, that improvements had taken place with respect to actual care outcomes, processes of care, patient satisfaction levels and/or other quality indicators. Additionally, surveyors would expect the HHA to demonstrate that all disciplines are involved in its QAPI program, consistent with the requirements of proposed § 484.75(c), below.

We believe that physician involvement in efforts to improve the outcome of patient care is vital and, as previously noted, we have addressed this issue by proposing the physician involvement requirement at proposed § 484.60, “Care planning, coordination of services, and quality of care.” We have also addressed this issue by requiring all HHA skilled professionals, which would include physicians employed by or under contract with the HHA, to participate in the HHA's QAPI program (see proposed § 484.75). Likewise, we encourage each HHA to consider the voluntary input of physicians who are not employed by or under contract with the HHA in designing, implementing, and evaluating its QAPI program. Physicians not employed by or under contract with the HHA may be in a unique position to provide a HHA's management and care delivery team with structured feedback and insight on ways that performance could be improved. We believe it would be overly burdensome and beyond the scope of these regulations to require non-employee and non-contract physicians to participate in specific QAPI activities. However, in developing an effective QAPI program, HHAs have found that including a physician in the planning and organization phase has helped to focus and refine the QAPI program.

7. Infection Prevention and Control (Proposed § 484.70)

In the current HHA CoPs, there is no requirement for an HHA-wide infection control program; however the current regulation at § 484.12(c) states that the HHA and its staff must comply with accepted professional standards and principles that apply to professionals furnishing services in an HHA. Infection control practices are part of accepted professional standards and principles, and thus should not be new to HHAs. We are proposing to establish a new CoP at § 484.70, “Infection prevention and control,” because we believe that it is appropriate to address this important issue as a distinct part of the regulatory process. We would organize this new condition under the following three standards: (1) Prevention, (2) control, and (3) education.

The effects of infectious and communicable diseases on patient health are significant. In response to this issue, the health care industry developed guidelines and recommendations for managing infection control programs that include health care settings. (“Requirements for infrastructure and essential activities of infection control and epidemiology in out-of-hospital settings: A Consensus Panel report” Association of Professionals in Infection Control (APIC) and the Society for Healthcare Epidemiology of America (SHEA), American Journal of Infection Control 27 (1999)) Additionally, accreditation organizations such as the Joint Commission responded to the issue of infection control by designing new infection control standards for, among others, home care providers. Other accrediting bodies have also chosen to include infection control requirements in their home care standards as well. Because of the negative impact onpatient health and safety posed by infectious and communicable diseases, and the significant amount of attention generated by this issue, we believe that HHAs need to address infection prevention and control in a more comprehensive manner.

We recognize that a HHA cannot be entirely responsible for the maintenance of a completely infection-free environment in an individual's home (where there are variables beyond the control of the HHA). However, by following “current best practices” (for example, following the standard precaution of wearing gloves when handling blood or blood products) in implementing the plan of care, the potential risks of infectious and communicable diseases can be greatly reduced for patients, families, and staff. We propose in § 484.70(a) that HHAs follow infection prevention and control best practices, which include the use of standard precautions, to curb the spread of disease.

Under proposed standard § 484.70(b), “Control,” we would expect the HHA to maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases. (Also see “Definitions for Surveillance of Infections in Home Health Care,” February 2008, http://www.apic.org/AM/Template.cfm?Section=Search&section=Surveillance_Definitions&template=/CM/ContentDisplay.cfm&ContentFileID=9898.) Many states have rules requiring reporting of certain communicable diseases to the department of health. In turn, the department of health typically conducts investigations. We would expect HHAs to work in conjunction with their respective health departments, who work in conjunction with the CDC, when developing and implementing their programs.

Additionally, under this proposal, the program would be expected to be an integral part of the agency's QAPI program. As part of the QAPI program, the infection prevention and control program would identify infectious and communicable disease problems that affect the provision of home health services, track patterns and trends, establish a corrective plan, and monitor for improvement and effectiveness of corresponding interventions.

Because infection prevention and control education is crucial to preventing the spread of communicable diseases, we are proposing an education standard within this CoP at § 484.70(c). HHAs would be expected to provide education on “current best practices” to staff, patients, and caregivers. This could be accomplished through in-service training for staff, and through the use of printed material, instructional videos, and in-home demonstration for patients and their families/caregivers. The training provided to patients and caregivers should be specific to their individual needs, such as safe practices for performing assisted monitoring of blood glucose as part of typical diabetes management. (See Infection Prevention during Blood Glucose Monitoring and Insulin Administration at http://www.cdc.gov/injectionsafety/blood-glucose-monitoring.html). The exact content and frequency of staff, patient, and caregiver education would be left to the discretion of individual HHAs, as established in their policies and procedures.

The proposed condition would allow the HHA flexibility in meeting its prevention, control, and education standards. For example, the amount of staff education time needed for infection control would depend on both staff experience and the patient population. While we would expect “current best practices” to be followed, we are not proposing any specific approaches to meeting this requirement; readers should visit the CDC Web site at http://www.cdc.gov/HAI/settings/outpatient-care-guidelines.html for more information about core infection control practices that apply to all outpatient health care settings.

We believe that this proposed infection control CoP follows, and is consistent with, the functions of infection control as defined in the APIC/SHEA Consensus Panel report. The report recommended that health care providers intervene directly to prevent infections; obtain and manage critical data and information, including surveillance for infections; develop and recommend policies and procedures; and educate and train health care workers, patients, and nonmedical caregivers. Further, we believe that the three-pronged approach of prevention, control, and education, as outlined in the proposed standards under this CoP, would accomplish the three principal goals of infection control as presented in the Consensus Panel report. These three goals are: (1) Protect the patient; (2) protect the health care worker (and others in the health care environment); and (3) accomplish the previous two goals in a manner that is timely, efficient, and cost-effective whenever possible. By maintaining an effective infection prevention and control program that is also an integral part of a QAPI program, a HHA would provide clear evidence of its efforts to minimize the spread of infectious and communicable diseases.

8. Skilled Professional Services (Proposed § 484.75)

This proposed new condition would consolidate and revise current conditions at § 484.30, “Skilled nursing services”; § 484.32, “Therapy services”; and § 484.34, “Medical social services”; and set forth the requirements for skilled professional services. Instead of specifically identifying tasks, we would broadly describe the expectations of the skilled professionals who participate in the interdisciplinary team approach to home health care delivery. Specifically, we would reduce the regulation's focus on administrative agency process requirements and shift the focus to outcomes of care. Skilled professionals, within this context, would provide services to HHA patients directly as employees of the HHA or under a contractual agreement. We propose that skilled professionals actively participate in the coordination of all aspects of care where appropriate. By doing so, they would become more aware of the need to function as part of an interdisciplinary team.

We have organized this proposed condition into three areas: (1) Provision of services by skilled professionals; (2) responsibilities of skilled professionals; and (3) supervision of skilled professional assistants. Skilled professional services, as proposed in § 484.75(a), include physician services, skilled nursing services, physical therapy, speech-language pathology services, occupational therapy, and medical social work services. This is consistent with the description of the home health services under the hospital insurance benefits at part 409, subpart E. Provision of services by skilled professionals, as proposed in § 484.75(b), would specify that skilled professional services may only be provided by health care professionals who meet the appropriate criteria spelled out in proposed § 484.115, “Personnel qualifications,” and who practice according to the HHA's policies and procedures.

We propose in § 484.75(b), “Responsibilities of skilled professionals,” that skilled professionals who provide services to HHA patients directly, or under arrangement, participate in coordinating all aspects of care, including:

• Assuming responsibility for the ongoing interdisciplinary assessment and development of the individualized plan of care in partnership with the patient, representative (if any), and caregiver(s);
• Providing services that are ordered by the physician as indicated in the plan of care;
• Providing patient, caregiver, and family counseling;
• Providing patient and caregiver education;
• Preparing clinical notes;
• Communicating with the physician who is responsible for the home health plan of care and other health care practitioners (as appropriate) related to the current home health plan of care; and
• Participating in the HHA's quality assessment and performance improvement program and HHA-sponsored in-service training.

We believe that an interdisciplinary approach is crucial for meeting the needs of home health patients.

In addition to the requirements for licensed professional services described above, we propose to include a requirement governing the supervision of skilled professional assistants at § 484.75(c). This would require a RN identified by the HHA to supervise the care provided by nurses such as licensed vocational nurses and licensed practical nurses. We also propose that all rehabilitative therapy assistant services would be provided under the supervision of a physical therapist (PT) or occupational therapist (OT) who meets the appropriate requirements of § 484.115. Furthermore, we believe that it is essential for all medical social services to be provided under the overall supervision of a MSW-prepared social worker who meets the requirements of § 484.115.

9. Home Health Aide Services (Proposed § 484.80)

Section 1891(a)(3)(D) of the Act requires the Secretary to establish minimum standards for home health aide training and competency evaluation programs. Section 1861(m)(4) of the Act requires Medicare-covered home health aide services to be furnished only by individuals who have successfully completed a training program approved by the Secretary. Currently, the CoP concerning home health aide services is set forth at § 484.36. In this rule, we propose to retain the current requirements while making clarifying and organizational changes to § 484.36. As part of our reorganization, this revised condition would be re-located at proposed § 484.80.

We also propose to incorporate into this new CoP the provisions concerning the qualification requirements for becoming a home health aide, currently located at § 484.4. In this proposed rule, these requirements would now be organized as nine standards under proposed § 484.80: (1) Home health aide qualifications; (2) content and duration of home health aide classroom and supervised practical training; (3) competency evaluation; (4) in-service training; (5) qualifications for instructors conducting classroom and supervised practical training; (6) eligible training and competency evaluation organizations; (7) home health aide assignments and duties; (8) supervision of home health aides; and (9) individuals furnishing Medicaid personal care aide-only services under a Medicaid personal care benefit.

As noted above, provisions concerning the qualifications for home health aides are set forth at current § 484.4, Personnel qualifications. We believe these specific qualifications would be more appropriately located in the section covering home health aide services. At proposed § 484.80(a)(1), we would specify the necessary requirements for an individual to be considered a qualified home health aide. A qualified home health aide would be an individual who has successfully completed one of the following: (1) A training and competency evaluation program that meets the requirements described in § 484.80(b) and § 484.80(c); or (2) a competency evaluation program that meets the requirements described in § 484.80(c); or (3) a nurse aide training and competency evaluation program that is approved by the state as meeting the requirements of § 483.151 through § 483.154 (State review and approval of nurse aide training and competency evaluation programs) and is currently listed in good standing on the state nurse aide registry; or (4) a state licensure program that meets the requirements described in § 484.80(b) and § 484.80(c).

In light of the high turnover rate within the home health aide work force, we believe that flexibility in qualification requirements would enable HHAs to recruit qualified aides from a wider pool of employee prospects. While the duties of nurse aides and home health aides are quite similar, the main difference is the environment in which the aides perform the services. An agency's internal policies and procedures would govern the home health aide orientation training to reflect the differences in duties, and the environments in which the duties are performed. HHAs would be free to add additional aide training requirements as desired in order to address any specialized needs within the HHA's patient population (for example, additional skills related to dealing with pediatric patients for HHAs that have pediatric programs).

Under proposed § 484.80(a)(2), we would retain the intent of the current requirement at § 484.4, and specify when a home health aide is deemed to have completed a program (as specified in proposed § 484.80(a)(1) above). This determination would be based on whether, since the most recent completion of a program, there was a period of 24 months or greater since completion of the last home health aide training during which none of the services furnished by the aide were for compensation. We would also stipulate that, if there had been a 24-month or greater lapse in furnishing services, the aide would need to complete another program before the home health aide can provide services, as specified in § 484.80(a)(1).

In this rule, we propose to retain the requirements for content and duration of training from current § 484.36(a). However, we have clarified this section. We propose, at § 484.80(b), to set forth the requirements for training content and its duration, training methods (classroom and practical), and training documentation. Proposed § 484.80(b)(1) and (2) regarding home health aide classroom and practical training instructor and duration requirements would be the same as in the current rule. The current regulation at § 484.36(a) contains provisions regarding qualifications for instructors of home health aide training and specifies which organizations are eligible to provide training. We would retain and reorganize these two provisions into two separate standards at § 484.80(e) and § 484.80(f), respectively. In addition, we would remove the definition for “supervised practical training” which appears in the current standard, and move it to a more appropriate place under § 484.2, Definitions.

The current requirement at § 484.36(a)(1)(i) requires that “communication skills” be part of the content of training for home health aides. Since home health aides are members of the interdisciplinary team and often visit a patient multiple times each week, they are in a position to observe changes in a patient's status and note the needs that are crucial and relevant to future treatment decisions for that patient. As such, home health aides should be able to report and document these changes in an appropriate manner to ensure that observations of a patient's status are described accurately to ensure optimal care. Therefore, in this proposed rule,we would require at § 484.80(b)(3)(i) that communication skills include the aide's ability to read, write, and verbally report clinical information to patients, representatives, and caregivers, as well as to other HHA staff. The intent of this proposed change is to ensure that home health aides would be able to communicate effectively with patients, caregivers, and HHA staff. We would not specify the primary language for employees of HHAs because we recognize that many languages may exist within a community. However, we believe that it is important that the HHA attempt to match patients with staff relative to their abilities to communicate with one another.

We propose to add a new skill requirement related to recognizing and reporting changes in skin condition, including pressure ulcers. Home health aides are often the staff members who have the most frequent in-person contact with patients, and are therefore more likely to be in a position to notice changes in skin condition and early stage pressure ulcers. Early identification and reporting by home health aides would enable early intervention by the HHA to treat and reverse such changes. We believe that this early intervention would be beneficial to patients.

At § 484.80(b)(4), we propose to retain the current provision at § 484.36(a)(3) with minor revisions. This provision would require the HHA to maintain documentation that the requirements for content and duration of home health aide classroom and supervised practical training have been met. Similarly, we propose to retain the HHA documentation requirement currently set out at § 484.36(b)(5), which requires the HHA to document that the requirements for both the competency evaluation and in-service training have been met. However, as noted above, we are now proposing to reorganize the current standard at § 484.36(b) into two separate standards, § 484.80(c) Competency evaluation, and § 484.80(d) In-service training. Therefore, we propose to incorporate a documentation provision, which would require the HHA to document that the requirements of the standard have been met.

We propose to address various requirements for the competency evaluation of home health aides in § 484.80(c). We propose to retain the requirement currently found at § 484.36(b)(1), which states that an individual may furnish home health aide services on behalf of an HHA only after the successful completion of a competency evaluation program as described in that section.

As noted in the previous section, we propose to better define the term “communication skills,” and would now require communication training as part of the home health aide training program (§ 484.80(b)(3)(i)). We also propose to include this skill among the subject areas which would be evaluated by observation of the home health aide performing the tasks.

An effective way to assess aide competency is by observing the performance of the aide with a patient. Direct observation of the aide providing services to a patient would provide assurance that the aide has knowledge and understanding of the task at hand. We believe it would be acceptable to conduct aide training on a mannequin, and to conduct a competency evaluation on a “pseudo-patient.” However, the pseudo-patient for the competency evaluation would have to be an individual, such as another aide or volunteer, whose age is representative of the primary population served by the HHA. The following skills would be evaluated: Communication skills, reading and recording vital signs, personal hygiene techniques, safe transfer techniques, and normal range of motion and positioning criteria (specified under paragraphs (b)(3)(i), (b)(3)(iii), (b)(3)(ix), (b)(3)(x), and (b)(3)(xi)). The skills would be evaluated by observing the aide's performance carrying out the task with a patient or volunteer. The task would be required to be carried out to completion to assure that the aide was capable of performing tasks thoroughly, correctly, and independently. In accordance with proposed § 484.80(c)(2), the competency evaluation described in this paragraph may be offered by any organization, except an HHA that has been subject to certain corrective actions as described in proposed paragraph (f) of this section.

Section 484.80(c)(3) would maintain the current requirement that a RN must perform the competency evaluation. In addition to the RN, we are now proposing that the competency evaluation be done in consultation with other skilled professionals, as appropriate, since we believe it is essential that a home health aide's competency be demonstrated in each specific task performed. However, we continue to believe that it is necessary that a RN actually perform the competency evaluation. Since we depend upon a RN to provide the foundation of home health aide training, it is necessary to use a RN to evaluate the skills learned in that training.

This rationale for the use of a RN in performing the competency evaluation is also the basis for the proposed change to the current regulation at § 484.36(b)(4)(i), which requires that if a home health aide is going to perform a task for which he or she was rated “unsatisfactory,” it must be performed under the supervision of a licensed nurse (either a licensed practical nurse or a RN) until he or she achieves an evaluation of “satisfactory.” We would modify this requirement at § 484.80(c)(4) by requiring that the task be performed under the supervision of a RN, not a licensed practical nurse.

In the current rule, at § 484.36(b), the provisions regarding in-service training and competency evaluations of home health aides are combined. We believe that these requirements should be separated into two standards: Competency evaluation, as discussed above, at proposed § 484.80(c), and in-service training at proposed § 484.80(d). Creating two standards would emphasize the importance of each of these areas. We would retain 12 as the minimum number of hours of in-service training required for a 12-month period. The training could occur while an aide was furnishing care to a patient. We continue to believe that requiring 12 hours of training in a 12-month period would not place an unreasonable burden on the resources of the organization furnishing the training. Using the 12-month period would allow HHAs considerable flexibility in scheduling and in providing training. We would expect that the start dates for the 12-month in-service training period would be the aides' dates of hire or calendar year, as defined by the HHA.

The proposed requirements for the home health aide competency evaluation discussed above, when coupled with this proposed requirement for in-service training, as well as ongoing aide supervision (as proposed in § 484.80(h)), would provide an environment conducive to safe and appropriate patient care. Further, by continuing to emphasize ongoing in-service training, HHAs would have the opportunity to develop programs that would promote aide understanding of selective aspects of care and advance aide competency in general. Proposed § 484.80(b) would set forth the elements that must comprise home health aide classroom and supervised practical training, thus suggesting that those elements of training should form a basis for ongoing in-service training. Because each HHA is unique and serves various populations, the proposed standard would allow a HHA to tailor its in-service training to the unique needs of the population it serves.

We would retain the requirements in this proposed rule that aide in-servicetraining could be offered by any organization, and that the training would be required to be supervised by a RN. We propose to relocate the requirement that the RN possess a minimum of 2 years of nursing experience, of which at least 1 year is in home health care, to standard (e), Qualifications for instructors conducting classroom and supervised practical training. We continue to believe that RNs with nursing experience in the home health field should be the principal instructors in the basic training of home health aides, since this is the foundation of an aide's education in patient care. Supplemental education, such as in-service training, could be adequately handled by qualified RNs who may not possess as much experience. For some basic aide training, however, individuals other than a RN may be able to provide instruction. When other individuals provide instruction to home health aides, classroom and practical training would be required to be under the general supervision of a RN who possessed a minimum of 2 years nursing experience, at least 1 year of which would have to be in home health care.

We propose to retain the current requirements at § 484.36(a)(2)(i) regarding organizations that offer aide training (generally, HHAs), with some revision and reorganization under a new standard at § 484.80(f), “Eligible training and competency evaluation organizations.” We propose to retain the current requirement that home health aide training may be provided by any organization, except an organization that falls under one of the exceptions specified in the regulation. These exceptions include, but are not limited to, agencies that have been found out of compliance with the home health aide requirements any time in the last 2 years, agencies that permitted an unqualified individual to function as a home health aide, and agencies that have been found to have compliance deficiencies that endangered patient health and safety. When selecting an outside organization to provide aide training, we encourage HHAs to select organizations with demonstrated knowledge and experience related to the subject matter(s) being taught.

We propose, at § 484.80(g), Home health aide assignments and duties, to set forth aide responsibilities and duties, and are retaining most of current § 484.36(c), Assignment and duties of the home health aide. However, we would make revisions to further support an interdisciplinary approach to care (as typified here and in § 484.60, Care planning, coordination of services, and quality of care).

Proposed § 484.80(g)(1) would provide that the home health aide would be assigned to a specific patient by the RN or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This proposed revision reflects an interdisciplinary team approach by adding the opportunity for additional skilled professionals to designate home health aide assignments. To the extent possible, we believe that there should be consistent assignment of aides to patients in order to facilitate continuity of care and communication. Currently, under § 484.36(c)(1), an appropriate skilled professional responsible for the supervision of the home health aide may provide only written patient care instructions for the home health aide. A RN is solely responsible for the assignments of home health aides to specific patients. However, we believe, for example, that if a patient is receiving physical therapy services, then the appropriate skilled professional (for example, a physical therapist) should be allowed to assign an aide to this patient. This is consistent with the current requirement at § 484.36(c) which require that the written patient care instructions for the home health aide be prepared by the appropriate professional responsible for the supervision of that home health aide. The ability to assess patients and take into account the many aspects of the patient's functioning would allow the RN or other skilled professional to identify patient needs, and match the skills of a particular home health aide to those needs.

Proposed § 484.80(g)(2) would require that the home health aide provide services that are ordered by the physician in the plan of care, that the home health aide is permitted to perform under state law, and that are consistent with the home health aide training. Home health aides could not furnish services outside of their scope of practice as defined by local and state laws, and the HHA's internal policies. In § 484.80(g)(3), we propose to retain the inclusive listing of duties for home health aides currently under § 484.36(c)(2).

At § 484.80(g)(4), we propose a requirement that home health aides be members of the interdisciplinary team, must report changes in the patient's condition to a RN or other appropriate skilled professional, and must complete appropriate records in compliance with the HHA's policies and procedures. As part of the interdisciplinary team, home health aides would be required to communicate to a RN or qualified therapist observations and experiences when caring for patients. Home health aides may observe changes in patient needs that are crucial to future treatment decisions, and these changes should be reported to the appropriate HHA professional in order to implement effective and appropriate changes in care. Under proposed § 484.80(g)(4), our intention is to reflect an interdisciplinary approach to care. In this case, the provision would emphasize the home health aide's role as a member of the interdisciplinary team. Because an aide may be the member of the home health team who is most often in the home with the patient, the aide may be the one most likely to note changes in a patient's condition. As observation skills are a required content area in aide training (see § 484.80(b)(3)(ii)), we would expect that aides be taught to identify any changes that may need to be reported to the RN or other skilled professional.

On-going home health aide supervision, as described in proposed § 484.80(h), “Supervision of home health aides,” is a necessary component of quality care for HHAs, and ensures that services provided by home health aides are in accordance with the agency's policies and procedures and in accordance with state and federal law. In this proposed standard, we would differentiate the aide supervision requirements based on the skill level of the care required by the patient. In proposed § 484.80(h)(1), we propose that if a patient is receiving skilled care, the home health aide supervisor (RN or therapist) must make an onsite visit to the patient's home no less frequently than every 14 days. The home health aide would not have to be present during this visit. If a potential deficiency in home health aide service was noted by the home health aide supervisor, then the supervisor would have to make an on-site visit to the location where the patient was receiving care in order to observe and assess the home health aide while he or she is performing care. In addition to the regularly scheduled 14-day supervision visits and the as-needed observation visits, HHAs would be required to make an annual on-site visit to a patient's home to observe and assess each home health aide while he or she is performing patient care activities. The HHA would be required to observe each home health aide with at least one patient, and would be allowed to increase the number of home health aide-patient interaction observations as necessary to assure a full assessment ofthe aide's patient care knowledge and skills.

In proposed § 484.80(h)(2), we would require that if home health aide services are provided to a patient who is not receiving skilled care, the RN must make an on-site visit to the location where the patient is receiving care no less frequently than every 60 days in order to observe and assess each home health aide while he or she is performing care.

Irrespective of the 14-day and 60-day requirements, the agency would be responsible for maintaining appropriate supervision of a home health aide, and could utilize more frequent supervision at its discretion (for example, when a home health aide learns new skills). The HHA would also be expected to increase supervisory oversight for those home health aides for whom a request for supervision had been made either by the patient, representative, caregiver, or a family member.

At proposed § 484.80(h)(3), we would require that if a deficiency in home health aide services was verified by the home health aide supervisor during an on-site visit, then the agency would have to conduct, and the home health aide would have to complete, a competency evaluation in accordance with paragraph (c) of this section. This proposed requirement would allow agencies to re-teach and reassess important home health aide skills to ensure that the home health aide provided safe and effective care to all patients at all times.

We also propose to add a new paragraph at § 484.80(h)(4) to ensure that home health aide supervision visits focus on the aide's ability to demonstrate initial and continued satisfactory performance in meeting essential criteria. Supervision visits would be required to assess the home health aide's success in following the patient's plan of care; completing tasks assigned to the home health aide; communicating with the patient, representative (if any), caregivers, and family; demonstrating competency with assigned tasks; complying with infection prevention and control policies and procedures; reporting changes in the patient's condition; and honoring patient rights.

We would not set forth a specific requirement relative to the method of documenting the supervisory visit, but we expect that the HHA would develop a method of documentation that best fit its needs. Proposed § 484.80(h)(5) would retain, with minor revisions, the current requirements found under § 484.36(d)(4) as they relate to the HHA's responsibilities for home health aides who are furnishing services under arrangement (that is, the aides are not employees of the HHA). The HHA would be required to ensure the quality of home health aide services, supervise aides as proposed in this section, and ensure that aides have met the training and competency evaluation requirements of this proposed part.

At proposed § 484.80(i), Individuals furnishing Medicaid personal care aide-only services under a Medicaid personal care benefit, we propose to retain the requirements at current § 484.36(e), with some minor clarifying revisions. Under this provision, a Medicare-certified HHA that provides personal care aide services to Medicaid patients under a State Medicaid personal care benefit would be required to determine and ensure the competency of individuals for those Medicaid-approved services performed. Placing this requirement within the HHA CoPs would afford protections to all individuals served in that setting, regardless of payer source. The requirements are designed to protect the patient, and are consistent with § 440.167(a), which states that patients receiving personal care services in their home are required to have a physician's authorization in accordance with a plan of treatment or a service plan approved by the state. Changes in the overall language of this provision would be made for the sake of clarity. In addition, the reference to § 440.170 in the current regulation at § 484.36(e)(2) is incorrect; it should read § 440.167. Therefore, we propose to make the necessary correction.

Proposed Subpart C, Organizational Environment

1. Compliance With Federal, State, and Local Laws and Regulations Related to Health and Safety of Patients (Proposed § 484.100)

Provisions concerning compliance with federal, state, and local laws are presently located at current § 484.12, “Condition of Participation: Compliance with Federal, State and local laws, disclosure and ownership information, and accepted professional standards and principles.” We propose to retain most of the provisions contained in this condition with minor changes, which are discussed below. This proposed condition would now be set forth at § 484.100.

We propose to incorporate the standard at current § 484.12(a) into the general opening statement of the condition at § 484.100. At proposed § 484.100(a), we would continue to require HHAs to comply with the requirements of part 420, subpart C by disclosing the names and addresses of all persons with an ownership or controlling interest, the name and address of each officer, director, agent, or managing employee, and the name and address of the entity responsible for the management of the HHA along with the names and addresses of the CEO and chairperson of the board of that entity. Section 1126(b) of the Act, codified in regulations at § 420.201 of our rules, specifies that the term “managing employee” means an individual, including a general manager, business manager, administrator, or director, who exercises operational or managerial control over the entity, or who directly or indirectly conducts the day-to-day operations of the entity. Accordingly, for purposes of this rule, “director” would refer to a corporate director and not a medical director or nursing director. Section 420.201 defines an “agent” as any person who has been delegated the authority to obligate or act on behalf of a provider. In this rule, we would intend an “officer” to be any person who is responsible for the overall management of the operation of the HHA; we also would require that the HHA provide information on all individuals who are officers of the HHA under the law of the state in which the HHA is incorporated. Because the business address of an agency is self-explanatory, the additional address we would request in the standard would refer to a residential address for all individuals to whom the rule applies. A Post Office Box address would not be considered a business or residential address and would not be satisfactory for purposes of compliance with this proposed requirement.

We propose to remove the provisions regarding state licensure from current paragraph § 484.12(a) and incorporate them into the proposed state licensure standard at § 484.100(b). Under the provisions of proposed § 484.100(b), a HHA, its branches, and its staff would be licensed, certified, or registered, as applicable, by the state licensing authority if the state had established licensure requirements. In addition, the Act at § 1861(o)(4) requires that a HHA, which would include a branch, must be licensed, or approved as meeting the standards established for licensing, in any state in which state or local law provides for the licensing or other approval of HHAs and their subsidiaries. If a state requires a HHA to have a license, then we would require that the provider be in compliance with that state's law or regulation. In addition, state licensure requirements are enforced at the state level and wouldbe subject to state jurisdiction. Therefore, the provisions of this proposed rule would not affect providers that have been granted waivers of state requirements.

State surveyors are not, and have never been, responsible for citing HHAs for violating the rules of regulatory bodies other than the State or CMS. When a HHA is found to be out of compliance with a federal, state, or local law by another regulatory agency with jurisdiction and authority to cite noncompliance (for example, OSHA or the Department of Justice), CMS decides whether that violation should also constitute a violation of the HHA CoPs. Both the title of this proposed CoP and its introductory paragraph would refer to only those federal, state, and local laws and regulations which were “related to the health and safety of patients.” We would cite agencies when the violation of federal, state, or local laws or regulations could potentially affect the health and safety of the HHA's patients, and the rights and well-being of patients.

Finally, we propose to move the current requirements at § 484.14(j), Laboratory services, to § 484.100(c). Because this standard covers compliance with a federal regulation, we believe that it would be better suited under this proposed CoP governing compliance with federal, state, and local laws rather than under its current location at the end of the CoP covering organization, services, and administration of an HHA. Section 484.100(c) would require that HHAs engaged in certain types of lab testing, with an appliance that has been approved for that purpose by the Food and Drug Administration, conduct testing in compliance with the requirements of 42 CFR part 493(Laboratory Requirements).

This section would also prohibit HHAs from substituting their own self-administered testing equipment, such as glucometers, in lieu of a patient's self-administered testing equipment when assisting a patient in administering the test. We propose this requirement to ensure that patients have access to their test results on their own equipment that is maintained in their home. This would allow patients to track their results over time and better understand the impact of their behaviors and choices upon their test results. Such understanding is an important step in fostering patient independence and positive patient outcomes. Agencies may use their own self-administered testing equipment as a complement to a patient's self-administered testing equipment when assisting a patient in administering the test when there is reason to believe that the patient's self-administered testing equipment is inaccurate. In this situation, we would expect the HHA to assist the patient in obtaining accurate testing equipment for future use. Agencies may also use their own self-administered testing equipment for a short, defined period of time when the patient has not yet obtained his or her own testing equipment, such as in the days immediately following physician orders to obtain the testing equipment when a patient may not have the time and resources immediately available to complete the process. We would expect the HHA to use available resources to assist the patient in obtaining his or her own testing equipment as quickly as possible.

In addition, this section would provide that if the HHA chose to refer specimens for laboratory testing, the referral laboratory would have to be certified in accordance with the applicable requirements of part 493. The laboratory services standard is a federal requirement in accordance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA). We are not proposing to alter the intent or meaning of this provision.

2. Organization and Administration of Services (Proposed § 484.105)

This proposed CoP on organization and administration of services would revise current regulations at § 484.14, “Organization, services, and administration.” As previously discussed, the current regulation at § 484.14(g), “Coordination of patient services,” would be relocated and revised under proposed § 484.60. In addition, the current regulations found at § 484.38, “Qualifying to furnish outpatient physical therapy or speech pathology services,” would be relocated to § 484.105. The proposed new condition would simplify the structure of the current requirements, and focus on both essential organizational structures and performance expectations for the administration of HHA operations. With the diffusion of home health organization and management structures (currently, there are 2,660 branches distributed among 1,301 parent HHAs nationwide), this proposed rule would help to ensure accountability by assisting agencies in setting performance expectations that we believe would lead to a higher level of quality for patients. The overall goal of the proposed condition is to produce a clear, accountable organization, management, and administration of a HHA's resources to attain and maintain the highest practicable functional capacity for each patient's medical, nursing, and rehabilitative needs, as indicated in the plan of care. Attaining and maintaining the highest practicable functional capacity for each patient is the primary goal of HHA services based on the premise that the role of the HHA is to assist each patient in overcoming any deficits that lead to his or her need for home health services. HHAs provide services, supplies, and education to patients, making every effort to encourage and support patient autonomy, self-care, self-management, and ultimately discharge from the HHA.

Under the current requirements found at § 484.14(b), we would expect the governing body to be able to assess the HHA's financial needs and to assume responsibility for effectively managing its financial resources. We would maintain the intent of this requirement, at proposed § 484.105(a), “Governing body,” and would expand the responsibilities of the governing body to assume full legal authority and responsibility for the agency's overall management and operation, the provision of all home health services, the review of the budget and operational plans, and the agency's quality assessment and performance improvement program, in addition to responsibility for the agency's fiscal operations, as retained from the current regulations.

Proposed § 484.105(b), “Administrator,” would describe the role of the administrator and provisions for when the administrator is not available. We propose that the administrator be appointed by the governing body, be responsible for all day to day operations of the HHA, and be responsible for ensuring that a skilled professional as described in § 484.75 is available during all operating hours. The current State Operations Manual (Pub 100-7, Appendix B, http://cms.hhs.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_b_hha.pdf) describes the concept of being available during operating hours as being on the premises of the HHA or by reachable via telecommunications. HHA management would have discretion to structure the implementation of this concept to suit the organization's needs. In addition, the current State Operations Manual also describes the concept of “operating hours” as all hours that staff from the agency is providing services to patients. Because HHAs are already familiar with these concepts, we are not proposing to change our interpretations.

While we would expect the administrator to be available during all operating hours to take an active role inthe daily operations of the HHA, we recognize that there are times when the administrator cannot be available. We propose that, any time when the administrator is not available, a pre-designated person, who is authorized in writing by the administrator and governing body, would assume the same responsibilities and obligations as the administrator, including the responsibility to be available during all operating hours. The pre-designated person may be the same skilled professional described above. We note that, in addition to this requirement, we also propose personnel requirements for the administrator at § 484.115(a). The administrator, and the pre-designated person, would be required to meet these personnel requirements.

In addition to the overall management of the HHA by the governing body and the administrator, we propose a new clinical manager role at § 484.105(c). The clinical manager would be a qualified licensed physician or registered nurse, identified by the HHA, who is responsible for the oversight of all personnel and all patient care services provided by the HHA, whether directly or under arrangement, to meet patient care needs. The supervision of HHA personnel would include assigning personnel, developing personnel qualifications, and developing personnel policies. Oversight of the services provided to patients would include, but would not be limited to, assigning clinicians to patients; coordinating care provided to patients by the various patient care disciplines; coordinating referrals within the HHA; assuring that patient needs are continually assessed; and assuring that patient plans of care are developed, implemented, and updated. We believe that the clinical manager role is essential for managing the complex, interdisciplinary care of home health patients, and that the responsibilities included in this new standard are not currently fulfilled. Six of the 20 most frequently cited survey deficiencies center on the need for patient care coordination and implementation, including the most frequently cited deficiency related to ensuring that each patient has a written and updated plan of care. These frequent deficiency citations indicate that patient care is not being sufficiently planned, coordinated, and implemented to ensure the highest quality care for all HHA patients at all times. We believe that having a designated clinical manager will address this need while assuring that agency personnel standards are upheld.

In § 484.105(d), we propose a new standard, Parent-branch relationship. As discussed previously in the “Definitions” section of this preamble, we would change the definition of “branch” in § 484.2 to define a branch office as a location or site from which a HHA provides services within a portion of the total geographic area served by the parent agency. We would delete the portion of the definition referring to a branch location that is “sufficiently close” to the parent agency, because section 506(a)(1) of the Medicare, Medicaid and State Children's Health Insurance Program Benefits Improvement and Protection Act of 2000 (Pub. L. 106-554) (BIPA) mandated that neither time nor distance between a parent office of the HHA and a branch office shall be the sole determinant of a HHA's branch office status. However, both time and distance can still be considered as factors in conjunction with other considerations.

We believe that the focus should be on the ability of the parent HHA to demonstrate that it can monitor all services provided in its entire service area, furnished by any branch offices, to ensure compliance with the CoPs. The decision to approve a branch is based on the HHA's ability to assure that the quality and scope of items and services provided to all patients from the branch meets each patient's medical, nursing, and rehabilitative needs. Thus, we would expect that the lines of authority and professional and administrative control be clearly delineated in the HHA's organizational structure and in practice. The HHA parent should be aware of the staffing, patient census and any issues/matters affecting the operation of the branch. Furthermore, the administrator of the HHA must be able to maintain an ongoing liaison with the branch to ensure that staff is competent and able to provide appropriate, adequate, effective and efficient patient care so as to ensure that any clinical and/or other emergencies are immediately addressed and resolved. The HHA parent must be able to monitor branch activities (clinical and administrative) and the management of services, as well as personnel and administrative issues, including providing ongoing in-service training to ensure that all staff is competent to provide care and services. The HHA parent is responsible for any contracted arrangements with other individuals or organizations, even when the contracted services are used exclusively by the branch. We would also expect the HHA to be able to demonstrate its ability to ensure that patients being served by all offices consistently receive all necessary and appropriate care and services described in the plans of care. As part of the decision-making process, we will also consider an HHA's past compliance history and all relevant state issues and recommendations. These and other considerations in governing parent-branch relationships were previously included in a Survey and Certification memorandum (Requests for Home Health Agency Branch Office Approval and the Use of a Reciprocal Agreement, S&C-02-30, issued May 10, 2002), and will inform future CMS subregulatory guidance on this topic.

We provide guidance for approving a branch office in § 2182.4B of the State Operations Manual. In addition, we assign identification numbers to every existing branch of a parent HHA and subunit. The identification system is implemented nationally, and uniquely identifies every branch of every HHA certified to participate in the Medicare home health program. It also links the parent to the branch. The branch identification number is also required on the OASIS assessments. This allows a HHA access to outcome reports that help it differentiate and monitor the quality of care delivered down to the branch level. (We note that although this information is available to HHAs, information is not broken down by branch when generating Home Health Compare results that are available to the general public.) Through this method of monitoring how services are furnished by its branches, the parent HHA can strengthen the parent-branch relationship and further ensure the quality of care delivered to its patients. We would also add to our regulations the requirement that HHAs report their branch locations to the state survey agency at the time of a HHA's initial certification request, at each survey, and at the time any proposed additions or deletions were made. This proposed rule would eliminate the “subunit” designation. An existing subunit currently operates under a distinct Medicare provider number and would be considered to be a distinct HHA upon implementation of this final rule, with its own governing body and administrator that is not shared with another HHA. Depending on state-specific laws and regulations, this regulatory change may allow a subunit to apply to become a branch office of a parent HHA if the parent could provide “. . . direct support and administrative control of the branch.”

In accordance with section 1861(m) of the Act, a HHA may provide its services directly and/or under arrangement withanother agency or organization. The agency providing services under arrangement may not have been denied Medicare enrollment; been terminated from Medicare, another Federal health care program, or Medicaid; had its Medicare or Medicaid billing privileges revoked; or been debarred from participating in any government program. Therefore, the current requirement at § 484.14(h) governing services under arrangement would be retained with a minor revision in the proposed standard at § 484.105(e), Services under arrangement. We propose to require that the primary HHA have a written agreement with another agency, with an organization, or with an individual, that it has contracted with to provide services to its patients, which stipulates that the primary HHA would maintain overall responsibility for all HHA care provided to a patient in accordance with the patient's plan of care, whether the care is provided directly or under arrangement. If the primary HHA chooses to furnish some services under arrangement, then it retains management, service oversight, and financial responsibility for all services that are provided to the patient by its contracted entities. All services provided by contracted entities would be authorized by the primary HHA, and furnished in a safe and effective manner by qualified personnel. In addition to this revision, we would correct a typographical error in the cross-reference citation for the United States Code.

We propose to move the current standard at § 484.14(a), “Services furnished,” to § 484.105(f)(1). According to section 1861(o) of the Act, for purposes of participation in the Medicare program, a HHA is defined as being “primarily engaged in providing skilled nursing services and other therapeutic services,” without reference to the services being provided on a part-time or intermittent basis as provided in the current regulation. Although certain payment-related requirements make reference to the intermittent nature of HHA services, the phrase “part-time or intermittent” is not used in the statutory definition of an HHA. In order to more closely align with the statutory definition, we propose to delete it from this standard. However, the use of the term “part-time or intermittent” would continue to exist under the coverage and eligibility requirements for home health services.

As stated in proposed § 484.105(f)(1), skilled nursing and one of the therapeutic services must be made available on a visiting basis in the patient's home. At least one service would be required to be provided directly by the HHA. This is a current requirement and would be retained. Other services could be offered under arrangement with another agency or organization. It should be noted that while HHAs may provide other services such as continuous nursing care either directly or under arrangement, those additional services might not be eligible for coverage under the Medicare program.

Additionally, we propose to retain the requirements of current § 484.12(c), “Compliance with accepted professional standards and principles,” at § 484.105(f)(2). We would continue to require that HHAs furnish all services in accordance with accepted professional standards of practice. We would also propose to require that all HHA services be provided in accordance with current clinical practice guidelines. We believe that this addition is necessary to ensure that HHA patients receive care that is based on clinical evidence, where available, and up-to-date medical practices.

Within this proposed CoP, we are moving current § 484.38, “Qualifying to furnish outpatient physical therapy or speech pathology services,” to § 484.105(g). We believe that this requirement would be more appropriately codified as a standard (now titled “Outpatient physical therapy or speech-language pathology services”) following the “Services furnished” standard under this proposed CoP. We propose to make no other changes to this standard.

Finally, we propose to retain the “Institutional planning” standard currently located at § 484.14(i) and as required for HHAs under § 1861(z) of the Act. We would retain this standard at § 484.105(h) without any revisions.

3. Clinical Records (Proposed § 484.110)

In this section of the preamble we describe: (A) Changes to the conditions of participation related to clinical record requirements; and (B) the HHS policy priority to accelerate interoperable health information exchange including through the use of certified electronic health record technology.

(A) Changes to the conditions of participation related to clinical record requirements. This proposed section would retain, with some additional clarification, many of the long-standing clinical record requirements currently found at § 484.48. In this condition, we propose to retain only those process requirements which provide essential patient health and safety protection.

The primary requirement under the proposed clinical records CoP would be that a clinical record containing pertinent past and current relevant information would be maintained for every patient who was accepted by the HHA to receive home health services. We propose to add the requirement that the information contained in the clinical record would need to be accurate, adhere to current clinical record documentation standards of practice, and be available to the physician who is responsible for the home health plan of care and appropriate HHA staff. The information could be maintained electronically. The clinical record would be required to exhibit consistency between the diagnosed condition, the plan of care, and the actual care furnished to the patient. Consistency would be reflected in the appropriate link between patient assessment information and the services and treatments ordered and furnished in the plan of care. In light of the decentralized nature of HHAs (that is, patient care is not furnished in a single location), we believe that members of the interdisciplinary team must have access to patient information in order to provide quality services. Many HHAs maintain electronic records, and we recognize that this technological change in home health care industry can provide all members of the interdisciplinary team access to important patient care information on an ongoing basis.

Proposed § 484.110(a), “Contents of clinical record,” contains several elements that are part of the current clinical record requirement. We propose to retain the requirement that the record include clinical notes, plans of care, physician orders, and a discharge summary. To give HHAs flexibility in maintaining clinical records, we propose to no longer specifically require that the name of physician and drug, dietary, treatment, and activity orders be included in a dedicated part of the clinical record, since these items would already have been made part of the plan of care, and thus would already be included in the clinical record. We also propose to add requirements to this standard that reflect our outcome-oriented approach to patient care. Specifically, at proposed § 484.110(a), we would require that the clinical record include: (1) The patient's current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical visit notes, and individualized plans of care; (2) all interventions, including medication administration, treatments,services, and responses to those interventions, which would be dated and timed in accordance with the requirements of proposed § 484.110(b); (3) goals in the patient's plan of care and the progress toward achieving the goals; (4) contact information for the patient and representative (if any); (5) contact information for the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA; and (6) a discharge or transfer summary note that would be sent to the patient's primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA within 7 calendar days, or, if the patient is discharged to a facility for further care, to the receiving facility within 2 calendar days of the patient's discharge or transfer. We believe that these timeframes are necessary to assure that providers assuming responsibility for the care of discharged patients have timely information about the patient's recent care, services, and medications. We request public comment regarding these timeframes. Specifically, we would like to know if these timeframes are adequate to assure a smooth transition of care. We would also like to know whether current HHA record systems are capable of producing a discharge summary in a shorter period of time, such as the same day that a patient is discharged.

We believe that these requirements are the minimum necessary for a meaningful clinical record, and that they would still provide the HHA with flexibility in maintaining the clinical record while ensuring that the record contains information necessary for providing high quality patient care. HHAs may choose to maintain additional information in the record which reflects activity pertinent to the patient and his or her care.

We propose to add a new standard at § 484.110(b) to require authentication of clinical records. We would require that all entries be legible, clear, complete, and appropriately authenticated, dated, and timed. Appropriate authentication refers to the process of identifying the person who has made an entry into the clinical record and that person's acknowledgement, by a signature and a title, or use of an electronic identifier, that he/she is responsible for the content, accuracy, and completeness of the entry. Authentication for every entry would be required to include a signature and a title, or a secured computer entry by a unique identifier, of a primary author who had reviewed and approved the entry. This provision would allow HHAs to establish clear policies about clinical record entries and corrections. It is preferred that the original clinician make any necessary corrections to his or her entries to ensure continuity and consistency within the clinical record. In cases where the original clinician is unable to correct his or her entry, we would expect to see documentation of communication with the original clinician regarding modifications to the original entry. We believe it is important to retain flexibility to accommodate the variation in types of documentation and decision making used throughout the industry, and the need to allow HHAs to innovate and improve documentation, including using electronic record formats, without unnecessary restrictions.

Under proposed § 484.110(c), we would revise the current requirements under § 484.48(a), “Retention of records.” With proposed § 484.110(c)(1), we would revise the provision regarding the timing of the 5-year clinical record retention period. We do not believe that the current provision, which predicates the beginning of the 5-year retention period on when the cost report is filed with the intermediary, ensures patient safety. Therefore, we have simplified the provision to now require that clinical records be retained for 5 years after the discharge of the patient, unless state law stipulates a longer period of time. In addition to these proposed clinical record retention requirements, HHAs would be expected to continue to comply with other Medicare or Medicaid record requirements for payment purposes.

We would continue to require, in § 484.110(c)(2), that HHA policies provide for retention of records even if the HHA discontinues operations. However, we also propose that the HHA would be required to notify the state agency as to where the agency's clinical records would be maintained. We also propose at § 484.110(d) to incorporate into this condition the requirement under current § 484.48(b), “Protection of records,” relative to the safeguarding of information. At proposed § 484.110(d), we would require that clinical records, their contents, and the information contained therein, be safeguarded against loss or unauthorized use. We believe that the requirement under current § 484.48(b), concerning the release of clinical record information, is best incorporated into the proposed standard at § 484.50(e), Right to confidentiality of clinical records, as noted earlier in this preamble.

Finally, under this clinical records condition, we would add a new standard at § 484.110(e), Retrieval of clinical records. We propose that a patient's clinical records (whether hard copy or electronic) be made readily available to a patient or appropriately authorized individuals or entities upon request. The provision of clinical records to those outside of the HHA would be required to be in compliance with the rules regarding personal health information set out at 45 CFR parts 160and 164.

We note that 45 CFR 164.512 provides for certain “disclosures required by law” without the permission of the patient. We believe that this standard is necessary for two main reasons. First, we believe that the prompt retrieval of patient records is essential to assuring communication, continuity and quality of care within the HHA, as well as between the HHA and other health care entities furnishing care to the patient. Second, in order to enable state surveyors to effectively assess HHA compliance with these regulations, and to enable the quality improvement organizations to fulfill their role in the beneficiary complaint process, timely retrieval of clinical records is essential.

(B) HHS Policy Priority to Accelerate Interoperable Health Information Exchange, including Use of Certified Electronic Health Record Technology.

HHS believes all patients, their families, and their healthcare providers should have consistent and timely access to their health information in a standardized format that can be securely exchanged between the patient, providers, and others involved in the patient's care. (cite: HHS August 2013 Statement, “Principles and Strategies for Accelerating Health Information Exchange.”) The Department is committed to accelerating health information exchange (HIE) through the use of electronic health records (EHRs) and other types of health information technology (HIT) across the broader care continuum through a number of initiatives including: (1) Alignment of incentives and payment adjustments to encourage provider adoption and optimization of HIT and HIE services through Medicare and Medicaid payment policies, (2) adoption of common standards and certification requirements for interoperable HIT, (3) support for privacy and security of patient information across all HIE-focused initiatives, and (4) governance of health information networks. These initiatives are designed to improve care delivery and coordination across the entire care continuum and encourage HIE among all health care providers,including professionals and hospitals eligible for the Medicare and Medicaid EHR Incentive Programs and those who are not eligible for the EHR Incentive Programs. To increase flexibility in the regulatory certification structure established by the Office of the National Coordinator for Health Information Technology (ONC) and expand HIT certification, ONC has proposed a voluntary 2015 Edition EHR Certification rule (http://www.gpo.gov/fdsys/pkg/FR-2014-02-26/pdf/2014-03959.pdf) to more easily accommodate HIT certification for technology used by other types of health care settings where individual or institutional health care providers are not typically eligible for incentive payments under the EHR Incentive Programs, such as home health agencies, and other long-term and post-acute care and behavioral health settings.

We believe that HIE and the use of certified EHRs by home health agencies (and other providers ineligible for the Medicare and Medicaid EHR Incentive programs) can effectively and efficiently help providers improve internal care delivery practices, support management of patient care across the continuum, and enable the reporting of electronically specified clinical quality measures (eCQMs). More information on the identification of EHR certification criteria and development of standards applicable to home health agencies can be found at the following locations:

• http://healthit.gov/policy-researchers-implementers/standards-and-certification-regulations
• http://www.healthit.gov/facas/FACAS/health-it-policy-committee/hitpc-workgroups/certificationadoption
• http://wiki.siframework.org/LCC+LTPAC+Care+Transition+SWG
• http://wiki.siframework.org/Longitudinal+Coordination+of+Care

In 2012, ONC sought public comment on whether it should focus any certification efforts towards the health IT used by health care providers that are ineligible to receive incentives under the EHR Incentive Programs. In the regulations establishing the 2014 Edition of health IT standards and EHR certification criteria (http://www.gpo.gov/fdsys/pkg/FR-2012-09-04/pdf/2012-20982.pdf), ONC concluded, “. . . that it makes good policy sense to support interoperability and the secure electronic exchange of health information between all health care settings. We believe the adoption of EHR technology certified to a minimal amount of certification criteria adopted by the Secretary can support this goal. To this end, we encourage EHR technology developers to certify EHR Modules to the transitions of care certification criteria (§ 170.314(b)(1) and § 170.314(b)(2)) as well as any other certification criteria that may make it more effective and efficient for EPs, EHs, and CAHs to electronically exchange health information with health care providers in other health care settings. The adoption of EHR technology certified to these certification criteria can facilitate the secure electronic exchange of health information.” ONC has also published, “Certification Guidance for EHR Technology Developers Serving Health Care Providers Ineligible for Medicare and Medicaid EHR Incentive Payments” (http://www.healthit.gov/sites/default/files/generalcertexchangeguidance_final_9-9-13.pdf).

In 2013, the Department of HHS requested information on how to accelerate interoperable health information exchange including with long-term and post-acute care providers. The public offered several recommendations for the use of EHR certification and the expansion of the ONC HIT Certification Program (See http://www.healthit.gov/sites/default/files/acceleratinghieprinciples_strategy.pdf. See page 5 for a summary of these recommendations). Among the suggested recommendations from the public was to make certified EHR technology available to long-term and post-acute providers (and other providers not eligible for the Medicare and Medicaid EHR Incentive Programs).

In the fall of 2013, ONC requested that the HIT Policy Committee (a Federal advisory committee established under the HITECH legislation and responsible for advising the National Coordinator for Health Information Technology on the development, harmonization, and recognition of standards, implementation specifications, and EHR certification criteria) to begin exploring the expansion of certification under the ONC HIT Certification Program, particularly focusing on EHR certification for the long-term and post-acute care and behavioral health care settings. The Certification/Adoption Workgroup of the HIT Policy Committee is expected to present its recommendations to the HIT Policy Committee in the spring of 2014. The full Health IT Policy Committee will make recommendations to the ONC in summer 2014.

As noted, the ONC publishes rules for health IT standards and EHR certification criteria. A key standard adopted in the 2014 Edition Final Rule was the HL7 Consolidated CDA (CCDA) standard. The CCDA is now the single standard permitted for certification and the representation of summary care records. This standard is used for the exchange of Summary Care Records at times of transition in care (for example, discharge) and making available clinical information to patients.

Activities have been undertaken to update the CCDA. The Standards and Interoperability Framework, Longitudinal Coordination of Care (S&I LCC WG) has worked to address gaps in the CCDA to better support the interoperable exchange of documents and content needed at times of transitions in care and referrals in care, and for the exchange of care plans, including the home health plan of care. The S&I LCC WG is a public/private collaboration. Members of this workgroup included representatives of the National Association of Home Care, Home Care Technology Association of America, the Visiting Nurse Service of New York, and many other clinicians, researchers, vendors, and government representatives. The updates to the CCDA were balloted by HL7 in the fall 2013, and comments have been reconciled. HL7 is expected to publish the CCDAr2 in spring 2014.

On February 26, 2014 ONC published the proposed rule for the 2015 Edition of Health IT standards and EHR certification criteria. The ONC 2015 Edition proposed rule proposes an updated version for the CCDA, the CCDA® Release 2 (CCDAr2). The CCDAr2 includes enhancements to more completely support interoperability for documents needed at times of transitions and referral in care and care plans, including the home health plan of care. The CCDAr2 includes new sections for: Goals; Health Concerns; Health Status Evaluation/Outcomes; Mental Status; Nutrition; Physical Findings of Skin; and many other entries.

We encourage home health providers to use, and their health IT vendors to develop, ONC-certified HIT/EHR technology to support interoperable health information exchange with physicians, hospitals, other LTPAC providers, and with their patients. We anticipate that the use of certified HIT/EHR technology will help improve quality and coordination of care, and reduce costs.

4. Personnel Qualifications (Proposed § 484.115)

Currently, provisions concerning the qualifications of HHA personnel are located at § 484.4. This section provides very specific credentialing requirements that all staff are required to meet. While we are retaining most of these current personnel qualification requirements,we propose revisions to the organization of the “Personnel qualifications” CoP. Many other provider types cross-reference the HHA personnel requirements, and we are proposing conforming amendments accordingly.

Under our proposed reorganization of part 484, personnel qualifications would be located at § 484.115. Personnel qualifications would be set out as general qualification requirements (which would cover all personnel), and personnel qualifications when state licensing laws or state certification or registration requirements exist (which would cover the additional requirements to practice under and in accordance with state laws, and which would cover all personnel where applicable). The proposed personnel qualifications CoP is discussed in detail below.

This proposed standard would consist of all personnel qualifications found under current § 484.4, with the exception of those for public health nurses. Except as noted below, we propose to retain the current personnel qualifications for the following professions: Administrator, audiologist, home health aide, licensed practical nurse, occupational therapist, occupational therapy assistant, physical therapist, physical therapist assistant, physician, registered nurse, social work assistant, and social worker.

We propose to delete the current qualification category for public health nurses because public health nurses are RNs, and the qualifications for RN are already included in this section. We also propose to replace the term “practical (vocational) nurse,” currently found in § 484.4, with the more widely used and accepted term, “licensed practical nurse.” The proposed qualifications for a licensed practical nurse would be a person who has completed a practical nursing program, and who furnishes services under the supervision of a qualified registered nurse. Currently, the requirements for the supervision of licensed practical nurses, occupational therapy assistants and physical therapist assistants, and social work assistants are found under § 484.30, § 484.32, and § 484.34, respectively. We propose to retain these supervision requirements and relocate them under the applicable profession's qualifications and as described in this proposed standard.

We also propose to revise the current personnel qualifications for HHA administrators. Our intent with this provision is to give HHAs flexibility. Therefore, with this provision we would expand the qualifications by which an individual could meet the requirement for an administrator. Specifically, proposed § 484.115(a) would set forth the requirements that a HHA administrator would be required to be a licensed physician, or hold an undergraduate degree, or be a registered nurse. We also propose that an administrator would have at least 1 year of supervisory or administrative experience in home health care or a related health care program. The possession of an undergraduate degree would be a new option for establishing the qualifications of an administrator that does not exist in the current regulations. We believe that this new option will give HHAs additional flexibility in selecting an appropriate administrator. However, we do not believe it is necessary to specify which undergraduate degree would be necessary to qualify for this option. Rather, we propose that the HHA's governing body would specify which undergraduate degree an HHA administrator would have to possess. In the absence of state requirements, we are not proposing to add financial management training as a requirement for HHA administrators at this time since HHAs often employ or consult a chief financial officer and billing staff, and the provision may place an additional burden on current HHAs. We specifically ask for comments on this proposal.

At § 484.105(a), the governing body would be responsible for appointing a qualified administrator, subject to the proposed requirements at § 484.115(a). If the governing body believed additional qualifications were required for an administrator, it could include these in its hiring criteria.

At § 484.115(k) and (l), we propose to retain the current requirements for both social work assistants and social workers, respectively. Currently, a qualified social worker is an individual who has a master's degree in social work (MSW) from an accredited school of social work and who has 1 year of social work experience in a health care setting. A qualified social work assistant is currently a person who has a baccalaureate degree in social work, psychology, sociology, or other field related to social work, and who has at least 1 year of social work experience in a health care setting. A social work assistant is also considered to be qualified under the current home health CoPs if he or she has 2 years of appropriate experience as a social work assistant and has achieved a satisfactory grade on a proficiency examination conducted, approved, or sponsored by the U.S. Public Health Service. However, determinations of proficiency do not apply with respect to persons initially licensed by a state or seeking initial qualification as a social work assistant after December 31, 1977. We believe that these current personnel requirements adequately meet the needs of HHA patients. We propose to clarify the requirement for a social worker by amending the regulation to state that those who hold a doctoral degree in social work would also meet the qualification requirements.

Finally, we propose to revise the personnel qualifications for speech-language pathologists (SLP) in order to more closely align the regulatory requirements with those set forth in section 1861(ll) of the Act. We propose that a qualified SLP is an individual who has a master's or doctoral degree in speech-language pathology, and who is licensed as a speech-language pathologist by the State in which he or she furnishes such services. To the extent of our knowledge, all states license SLPs; therefore all SLPs would be covered by this option. We believe that deferring to the states to establish specific SLP requirements would allow all appropriate SLPs to provide services to beneficiaries. Should a state choose to not offer licensure at some point in the future, we propose a second, more specific, option for qualification. In that circumstance, we would require that a SLP has successfully completed 350 clock hours of supervised clinical practicum (or is in the process of accumulating supervised clinical experience); performed not less than nine months of supervised full-time speech-language pathology services after obtaining a master's or doctoral degree in speech-language pathology or a related field; and successfully completed a national examination in speech-language pathology approved by the Secretary. These specific requirements are set forth in the Act, and we believe that they are appropriate for inclusion in the regulations as well.

Read More:

https://www.federalregister.gov/articles/2014/10/09/2014-23895/medicare-and-medicaid-program-conditions-of-participation-for-home-health-agencies