la-202609-f1367b866a: Program for All-Inclusive Care of the ElderlyLicensing Standards

Department of Health Health Standards Section Program for All-Inclusive Care of the ElderlyLicensing Standards (LAC 48:I.Chapter 43) The Department of Health (the department), Health Standards Section proposes to promulgate LAC 48:I.Chapter 43 as authorized by R.S. 36:254 and R.S. 40:2120.61 et seq. This proposed Rule is promulgated in accordance with the provisions of the Administrative Procedure Act, R.S. 49:950 et seq. The department proposes to promulgate the provisions governing the licensing of program for all-inclusive care of the elderly providers in order to comply with the requirements of the following Acts of the 2024 Regular Session of the Louisiana Legislature: Act 444 that authorizes the department to promulgate rules for PACE providers, and Act 624 that requires PACE providers to implement workplace violence mitigation initiatives. The proposed Rule text below has been drafted utilizing plain language principles to ensure clarity and accessibility for all users. It has also been reviewed and tested for compliance with web accessibility standards. Title 48 PUBLIC HEALTH—GENERAL Part I. General Administration Subpart 3. Licensing and Certification Chapter 43.Program for All-Inclusive Care of the Elderly Providers (PACE) Subchapter A.General Provisions §4301.Introduction A.PACE providers shall deliver prepaid, capitated, comprehensive healthcare services to meet the following goals: 1.enhance the quality of life and independence for frail, older adults; 2.maximize dignity of, and respect for, older adults; and 3.preserve and support the older adult’s family unit. B.A PACE provider shall have a written statement describing its philosophy, long-term goals, and short-term goals. The PACE provider program statement shall include goals that: 1.promote the participant's maximum level of independence; 2.maintain the participant's present way of doing things for as long as possible. Also, preventing or delaying them from getting worse; 3.restore and rehabilitate the participant to the highest level of functioning; 4.provide support and education for families and other caregivers; 5.help with participation, socialization, and peer interaction; and 6.serve as a part of the community services network and the long-term care continuum of services. C.Each entity that meets the definition of a PACE provider shall submit an initial licensing application. The entity shall also submit a non-refundable licensing fee. Submission shall be within 90 calendar days of the promulgation of the initial rules, regulations, and licensing standards. 1.If not licensed within 180 calendar days after submission of its initial licensing application and non-refundable fee, the entity shall: a.cease and desist operations as a PACE provider; and b.ensure the safe and orderly discharge of all participants until licensed as a PACE provider by the department. D.A PACE provider may provide all the following services to approved PACE participants: 1.home and community-based services (HCBS), as defined in R.S. 40:2120.1 et seq., or current law; 2.adult day healthcare (ADHC) services, as defined in R.S. 40:2120.41 et seq., or current law; and 3.home health agency (HHA) services, as defined in R.S. 40:2116.31 et seq., or current law. E.A licensed PACE provider shall not be required to obtain a separate HCBS provider license, a separate ADHC facility license, or a separate HHA license, to provide such services to approved PACE participants. However, the PACE provider shall ensure that services offered are in substantial compliance with all applicable local, state, and federal laws and regulations. Services offered shall also be in accordance with the PACE program agreement. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: §4303.Definitions A.The following definitions of selected terminology are used in connection with this Chapter. Abuse—willful infliction of injury or the causing of the deterioration of a participant by means including, but not limited to physical, verbal, emotional, psychological, sexual abuse, exploitation, or extortion of funds or other things of value to such an extent that the participant’s health, moral, or emotional well-being is endangered. a.The determination of abuse shall not be mitigated by a participant’s age, ability to comprehend, or disability. Abuse determination shall be based on the reasonable person concept. Access to Services—care that meets the needs of each participant across all care settings, 24 hours a day, every day of the year. A written plan shall be established and implemented to ensure that care is appropriately furnished. Accreditation—a process by which a provider with an executed agreement between the provider, Centers for Medicare and Medicaid Services (CMS) and Department of Health (LDH) for the operation of a PACE program, shall be deemed as meeting the PACE licensing requirements. Activities of Daily Living (ADL)—the functions or tasks that are performed either independently or with supervision, or assistance for mobility (e.g., transferring, walking, grooming, bathing, dressing and undressing, eating, and toileting). For the purposes of this Chapter, ADL shall also include taking medications. Center—a facility that includes a primary care clinic and areas for therapeutic recreation, restorative therapies, socialization, personal care, and dining. The center serves as the focal point for coordination and provision of most PACE services. Center Manager—a designated staff person, who oversees daily operations within the center, ensuring delivery of care and services to participants while they are on-site. In addition, the center manager: a.manages center staff; b.coordinates activities; c.ensures compliance with regulations; and d.collaborates with the interdisciplinary team to support participants' comprehensive person-centered service plan. Cessation of Business—the provider is non-operational and/or has stopped offering or providing services to the community. Change of Ownership (CHOW)—a change in the legal entity responsible for the PACE operation. Chemical Restraint—a medication used to control behavior or to restrict the participant's freedom of movement and is not a standard treatment for the participant's medical or psychiatric condition. Complaints—allegations of non-compliance with regulations filed by someone other than the provider. Comprehensive Person-Centered Service Plan (CPSP)—a service plan, person centered and developed for each participant. The CPSP shall be based on comprehensive assessments that identify the participant’s strengths and needs. The CPSP shall establish goals and objectives so that outcomes to service delivery can be measured. Department—Department of Health (LDH) or any agency or office thereof designated by the secretary to administer the provisions of these regulations and its representatives. Direct Care Staff (DCS)—those participants who, through interpersonal contact with participants or participant care management, provide care and services to allow participants to attain or maintain the highest possible physical, mental, and psychosocial well-being. Elopement—leaving the center or home without appropriate supervision, if the participant’s CPSP indicates supervision is required. Emergency Medical Condition—a condition manifesting itself by acute symptoms of sufficient severity (including severe pain) such that a prudent layperson, with an average knowledge of health and medicine, could reasonably expect the absence of immediate medical attention to result in the following: a.serious jeopardy of the health of the participant; b.serious impairment to bodily functions; or c.serious dysfunction of any bodily organ or part. Employee—person who performs a job or task for compensation, such as wages or a salary. An employed person may be one who is contracted or one who is hired for a staff position. Full-Time Equivalent—40 hours of employment per week or the number of hours the center is open per week, whichever is less. Geographic Service Area (GSA)—the LDH administrative region where the provider’s primary business office is located. To protect patient care and access, a PACE provider may request permission from LDH to expand its licensed GSA on a limited basis. The expanded GSA shall serve certain zip codes in a parish that is contiguous to the LDH administrative region. The PACE provider shall meet the following conditions: a.No other licensed PACE provider is licensed to provide services in the proposed expanded GSA. b.The PACE provider demonstrates it can deliver all required PACE services in the expanded GSA. The PACE provider shall also provide continued 24-hour emergency and home-based care. The PACE provider shall do this without lowering the quality of care for current participants. c.The PACE provider submits a written, limited license expansion request to the Health Standards Section (HSS). The written request shall identify the expanded GSA zip codes in a parish contiguous to the LDH administrative region, shall identify the timeframe for the expansion request, and shall include data showing the need for the PACE services in the expanded GSA. The written request shall include an updated GSA map and participant residence data showing whether there is a need for an alternative care site. LDH HSS shall consult with the LDH Office of Aging and Adult Services (OAAS) and shall issue a decision within 60 days of receiving a complete request. d.Approved expansions for the licensed GSA are strictly limited to their authorized terms. e.Approved expansions for the licensed GSA shall be limited once a new PACE provider is licensed in that other LDH administrative region. i.Once a new PACE provider is licensed, existing PACE providers with approved limited expansions shall give freedom of choice notices to their current clients in the expanded GSA. If a current client chooses to stay with the existing PACE provider, then the existing PACE provider may continue serving that current client in the expanded GSA. The existing PACE provider shall not admit new clients from the expanded GSA. This care for existing clients may only continue to finish out services for those specific clients if the clients choose to stay. ii.Once all current clients transition out, the approved expansion for the licensed GSA will be terminated. The PACE provider shall stop operating in that expanded licensed GSA. The PACE provider shall then resume serving clients only within the LDH administrative region of its primary business office. f.Any limited expansion for the licensed GSA approved by LDH still requires CMS approval pursuant to 42 CFR 460.10 et. seq. i.Application for CMS approval is required by both CMS and LDH. The application shall be included in the PACE organization agreement. ii.Additionally, if the limited expansion for the licensed GSA is terminated under (5)(b) above, then the PACE provider shall submit an updated application for CMS approval. The updated application shall be included in the PACE organization agreement. NOTE: Approved limited expansion terminates once a new PACE provider is licensed in the LDH administrative region. PACE providers with approved limited expansions may continue serving only their current clients in the expanded area. This care may only continue to finish out services for those specific clients if the clients choose to stay. Once all current clients transition out, the expanded PACE provider shall stop operating in that area. It shall then resume serving clients only within the LDH administrative region of its primary business office. Governing Body—the person or group of persons that assumes full legal responsibility for determining, implementing, and monitoring policies governing the PACE's total operation. Grievance—an allegation, either oral or written, expressing dissatisfaction with service delivery or the quality of care furnished, regardless of whether remedial action is requested. Grievances may be between: a.participants and the PACE provider; or b.any other entity or participant through which the PACE provider provides services to the participant. Health Standards Section (HSS)―the section of the LDH that has responsibility for licensing all healthcare facilities in Louisiana that are subject to licensing statutes. Instrumental Activities of Daily Living (IADL)—the functions or tasks that are not necessary for fundamental functioning. IADL assists a participant to live in a community setting. These include activities such as: a.light house-keeping; b.food preparation and storage; c.grocery shopping; d.laundry; e.scheduling medical appointments; f.financial management; g.arranging transportation or transporting participants to medical appointments; and h.accompanying the participant to medical appointments. Interdisciplinary Team (IDT)—healthcare professionals from various specialties and direct care staff. The IDT works together to provide comprehensive care to participants. This team approach: a.combines the expertise and skills of different disciplines to address the various needs of participants; and b.ensures that all aspects of participants' healthcare are considered. Key Staff—executive director, medical director, center manager(s), social worker(s), quality improvement coordinator, registered nurse(s), or licensed practical nurse(s) employed by the provider. License—a license issued by the department to a PACE provider. Licensed Practical Nurse (LPN)—an individual currently licensed by the Louisiana State Board of Practical Nurse Examiners to practice practical nursing in Louisiana. The LPN works under the supervision of a registered nurse. Line of Credit (LOC)—a credit arrangement with a federally insured, licensed lending institution. The LOC is established to ensure that the PACE provider has available funds as needed to continue the operations of the agency and the provision of services to participants. The LOC shall be issued to the licensed entity. The LOC shall be specific to the geographic location shown on the license. For purposes of PACE licensure, the LOC shall not be a loan, credit card, or a bank balance. Louisiana Adverse Actions List (LAAL)—the adverse action database, or its successor, maintained by the department or its designee. The LAAL contains all individuals or providers who are sanctioned, which may include exclusions or for-cause terminations through LDH. Minimal Harm—negative impact of injury causing the least possible physical or mental damage. Misappropriation—taking possession of a participant’s personal belongings without the participant’s permission to do so. Misappropriation is also the deliberate misplacement, exploitation, or wrongful temporary or permanent use of a participant’s belongings or money without the participant’s consent. Neglect—failure of the PACE provider, its employees, contractors, or service providers to provide goods and services to a participant necessary to avoid physical harm, pain, mental anguish, or emotional distress. Nurse Practitioner―an advanced practice registered nurse as defined by R.S. 37:913, or current law. Non-Operational—a provider that is not providing services according to the executed PACE program agreement. OPH—the Department of Health, Office of Public Health. PACE Enrollee—a recipient or participant that has been approved by Medicare or the Louisiana Medicaid Program or is otherwise qualified to enroll as a PACE participant for PACE services provided by an approved and licensed PACE provider. An individual is qualified to enroll as a PACE participant for PACE services if the individual: a.is 55 years of age or older; b.resides in a PACE service area; c.meets the level of care required under the Louisiana Medicaid Plan for coverage of nursing facility services as determined by the state; and d.can live in a community setting without jeopardizing the individual’s health or safety at the time of enrollment. PACE Services—those healthcare and related services approved by the CMS for Medicare and Louisiana Medicaid programs as PACE services. PACE services include but are not limited to: a.primary care; b.social work services; c.restorative therapies; d.personal care and support services; e.nutrition counseling; f.recreational therapy; g.transportation; h.meals; i.medical specialists’ services; j.laboratory tests; k.x-rays; l.durable medical equipment; and m.other services determined necessary by an IDT to improve and maintain the participant's overall health status. Personal Assistance—services that directly assist a participant with certain ADL and IADL. Personal Representative—an adult relative, friend, or guardian of a participant who has an interest or responsibility in the participant's welfare. This individual may be designated by the participant to act on his or her behalf and should be notified in case of emergency and/or any change in the condition or care of the participant. Physician Assistant―a licensed physician assistant in accordance with R.S. 37:1360.22, or current law. Physical Restraint—any manual method (e.g., therapeutic or basket holds, and prone or supine containment) or physical or mechanical device material (e.g., arm splints, leg restraints, lap trays that the participant cannot remove easily, posey belts, posey mittens, helmets). Physical restraint also includes equipment attached or adjacent to the participant's body that interferes or restricts freedom of movement or normal access to one’s body and cannot be easily removed by the participant. Primary Care Provider—a physician, nurse practitioner, or physician assistant who is designated by the participant or his or her personal representative as responsible for the direction of the participant's overall medical care. Program Director—the person designated by the governing body of the PACE provider who is responsible for oversight and administration of the entity. Program for All-Inclusive Care of the Elderly Program Agreement—an agreement with the PACE provider, CMS, and the Department of Health for the operation of a PACE program. Program for All-Inclusive Care of the Elderly Provider—a facility, place, center, agency, person, institution, corporation, partnership, unincorporated association, group, organization, or other legal entity that meets the requirements of 42 CFR 460 et seq. A PACE provider shall be approved and enrolled or shall intend to be approved and enrolled as a PACE provider by the CMS and Louisiana Medicaid Programs to provide services to Medicare and Medicaid recipients, or other qualified individuals who choose PACE services. A PACE provider shall not provide services to any person that is not an approved PACE enrollee. Progress Notes—ongoing assessments of the participant that enable the staff to update the CPSP in a timely, effective manner. Quality Improvement Coordinator—a designated individual to coordinate and oversee implementation of quality assessment and performance improvement activities. Registered Nurse (RN)—an individual currently licensed by the Louisiana State Board of Nursing to practice professional nursing in Louisiana. Revocation—action taken by the department to terminate a PACE license. Secretary—secretary of the Department of Health, or his designee. Social Worker—an individual responsible for arranging medical and/or social services needed by the participant. Volunteer—a person who provides services at a PACE center without compensation. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: §4305.Licensure Requirements A.All PACE providers shall be licensed by LDH. LDH is the only licensing authority for PACE providers in the state. It shall be unlawful to provide PACE services without possessing a current, valid license issued by LDH. The license shall: 1.be issued only for the entity or person and premises named in the license application; 2.be valid only for the PACE provider to which it is issued; 3.be only for the single specific geographic service location listed on the license. If providing services in multiple geographic service locations, the PACE provider shall obtain a separate PACE provider license for each geographic service location it provides services in; 4.be valid for 12 months beginning from the month of issuance, unless: a.revoked; or b.otherwise suspended prior to that date; 5.expire on the last day of the 12th month after the date of issuance, unless otherwise renewed; 6.not be subject to: a.sale; b.assignment or c.other transfer, voluntary or involuntary; and 7.always be posted visibly in a public area of the PACE center. B.A PACE provider shall be considered operational and shall retain licensed status under the following conditions. The PACE provider shall have: 1.at least one employee on duty at the business location during operational days and hours. Once a participant is enrolled, the PACE provider shall ensure adequate 24-hour coverage and care; 2.enough trained direct care and professional staff, either employed or contracted, available to provide care and services to participants at all times; 3.provided services to at least two participants in the past 12 months prior to their re-licensure; and 4.at least one business telephone number published. C.No provider, place, center, agency, person, institution, corporation, partnership, unincorporated association, group, organization, or other legal entity providing PACE services may be established or operated, or be reimbursed under the Medicaid program, unless licensed as a PACE provider to perform such services by the department. D.If a PACE provider is operating without a license issued by the department, the department shall have the authority to issue an immediate cease-and-desist order to the PACE provider. A PACE provider receiving such cease-and-desist order from the department shall immediately cease operations. The PACE provider may resume operations once a license is issued by the department. E.The department shall seek an injunction in the Nineteenth Judicial District Court against any PACE provider that receives a cease-and-desist order from the department under Subsection D of this Section and does not cease operations immediately. Any PACE provider against whom an injunction is granted shall be liable to the department for: 1.attorney fees; 2.costs; and 3.damages. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: §4307.Initial License Application Process A.Prior to an applicant providing PACE services, the applicant shall: 1.obtain an initial application for licensing as a PACE provider; 2.submit a completed initial license application packet to the department; and 3.receive approval from the department. B.The initial licensing application packet shall include at a minimum the following: 1.a completed PACE licensure application. The application shall be on forms prescribed by the department that contain: a.the name(s), address(es), and contact information of the: i.person(s); ii.partnership(s); iii.corporation(s); iv.unincorporated association(s); or v.other legal entity that is the applicant; b.if applicable, the name(s) and address(es) of the: i.applicant(s); ii.officer(s) iii. director(s); iv.manager(s); and v.administrator(s); c.the non-refundable licensing fee as established by statute; d.a copy of the approval letter of the architectural center plans from the Office of State Fire Marshal (OSFM); e.a copy of the on-site inspection report with approval for occupancy by the OSFM; f.a copy of the health inspection report with approval of occupancy report of the PACE provider from OPH; g.attestation of state-wide criminal background checks conducted by the Louisiana State Police, or its authorized agent, of an owner, officer, member, manager, administrator, director, or person designated to manage or supervise participant care. Such state-wide criminal background checks shall be made available for LDH review upon request. State-wide criminal background checks shall confirm that no owner, officer, member, manager, administrator, director, or person designated to manage or supervise participant care: i.has pled guilty or nolo contendere to a felony; or ii.has been convicted of a felony, as documented by a certified copy of the record of the court; h.proof of financial viability including: i.a LOC issued from a federally insured, licensed lending institution for at least $50,000; ii.compliance with the Louisiana Workers’ Compensation Law, R.S. 23:1020.1 et seq., or current law; and iii.general and professional liability insurance of at least $300,000; i.if applicable, clinical laboratory improvement amendments (CLIA) certificate or CLIA certificate of waiver; j.a completed disclosure of ownership and control information form; k.a floor sketch or drawing of the premises to be licensed; l.the days and hours of operation; and m.any other documentation or information required by the department for licensure. C.If the initial licensing packet is incomplete, the applicant shall be notified. Within 90 calendar days from the date of the notice letter indicating that the packet is incomplete, the applicant shall submit the additional requested information. If the additional requested information is not submitted to the department within 90 calendar days of the date of the notice letter, the application shall be closed. After an initial licensing application is closed, an applicant shall submit: 1.a new initial licensing packet; and 2.a new initial, non-refundable licensing fee. D.Once the initial licensing application packet is approved by LDH, the applicant shall receive notification. The notification shall include instructions for requesting the announced initial licensing survey. E.An applicant who has received the notification with instructions for requesting the announced initial licensing survey, shall notify the department of readiness for an initial licensing survey within 90 calendar days of the date of receipt of that notification. If an applicant fails to notify the department of readiness for an initial licensing survey within 90 calendar days of submission of a completed licensing packet, the initial licensing application shall be closed. After an initial licensing application is closed, the PACE provider shall submit: 1.a new initial licensing packet; and 2.a new initial non-refundable licensing. F.Before the PACE provider shall be issued an initial license to operate by LDH, the applicant shall comply with all appropriate federal, state, departmental, or local statutes, laws, ordinances, rules, regulations, and fees. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: §4309.Initial Licensing Surveys A.Prior to the initial license being issued to a PACE provider, an initial licensing survey shall be conducted. The survey shall be conducted on-site at the PACE provider. The purpose of the survey is to ensure compliance with PACE licensing standards. B.Should the initial licensing survey find the PACE provider is compliant with all licensing laws, regulations, and all other required statutes, laws, ordinances, rules, regulations, and fees, the department shall issue a full license to the PACE provider. The license shall be valid until the expiration date shown on the license, unless the license is: 1.modified; 2.revoked; 3.suspended; or 4.terminated. C.The department shall deny the initial license if the initial licensing survey finds that the PACE provider is noncompliant with any licensing laws or regulations that are a threat to the: 1.health; 2.safety; or 3.welfare of the participants. D.The department shall deny the initial license if the initial licensing survey finds that the PACE provider is noncompliant with any other required statutes, laws, ordinances, rules, or regulations that are a threat to the: 1.health; 2.safety; or 3.welfare of the participants. E.If the initial licensing survey finds that the PACE provider is noncompliant with any licensing laws, rules or regulations, but the department in its sole discretion determines that the noncompliance does not present a threat to the health, safety, or welfare of the participants, the department may issue a provisional initial license. The provisional initial license shall be for a period not to exceed six months. The provisional license may be extended at the sole discretion of the department. The PACE provider shall be required to correct all such noncompliance or deficiencies prior to the expiration of the provisional license. If all such noncompliance or deficiencies are determined by the department to be corrected on a follow-up survey, then a full license shall be issued. If all such noncompliance or deficiencies are not corrected on the follow-up survey, the provisional license shall expire. Upon expiration of the provisional license, the PACE provider shall be required to begin the initial licensing process again. The PACE provider shall be required to submit: 1.a new initial license application packet; and 2.non-refundable licensing fee. F.Initial licensing survey of a PACE provider shall be an announced survey. Follow-up surveys to the initial licensing surveys shall be unannounced surveys. G.Once a PACE provider has been issued an initial license, the department may conduct licensing surveys at intervals as deemed necessary by the department. The purpose of licensing surveys is to determine compliance with licensing regulations. The licensing surveys shall be unannounced. Investigations of complaints may also be conducted. 1.A follow-up survey shall be conducted for any licensing survey where deficiencies were cited. The follow-up survey shall occur to ensure correction of deficient practices. 2.The department may issue appropriate sanctions for any cited deficiencies and noncompliance of the state licensing requirements. Sanctions may include, but not be limited to: a.civil monetary penalties; b.directed plans of correction; c.license revocation; and/or d.denial of license renewal. H.LDH surveyors and staff shall be: 1.given access to all areas of the PACE provider; 2.given access to all relevant files during licensing surveys; and 3.allowed to interview any PACE provider staff or participant as necessary to conduct the survey. I.The PACE provider shall be open at reasonable times for inspection by: 1.the department; 2.the OSFM; and 3.any other authorized governmental entity. J.Plan of Correction (POC). A POC shall be required from a PACE provider for any survey where deficiencies have been cited. The POC shall be filed with HSS within 10 calendar days after the PACE provider’s receipt of notification and statement of deficiencies. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: §4311.Types of Licenses A.The department shall have the authority to issue the following types of licenses. 1.If the initial licensing survey finds that the PACE provider is compliant with all licensing laws and regulations, and is compliant with all other required statutes, laws, ordinances, rules, regulations, and fees, the department shall issue a full license to the PACE provider. The license shall be valid until the expiration date shown on the license: a.unless the license is modified; b.unless the license is revoked; c.unless the license is suspended; or d.unless the license is terminated. 2.If the initial licensing survey finds that the PACE provider is noncompliant with any licensing laws or regulations or any other required statutes, laws, ordinances, rules, regulations, or fees, the department is authorized to issue a provisional initial license pursuant to the requirements and provisions of §4309.E. 3.The department may issue a full renewal license to an existing licensed PACE provider who is in substantial compliance with all applicable federal, state, departmental, and local statutes, laws, ordinances, rules, regulations and fees. The license shall be valid until the expiration date shown on the license: a.unless the license is modified; b.unless the license is revoked; c.unless the license suspended; or d.unless the license is terminated. 4.The department in its sole discretion may issue a provisional license to an existing licensed PACE provider. The provisional license may be for a period not to exceed six months, unless extended by the department in its sole discretion. A provisional license may be issued if the existing PACE provider: a.has more than five deficient practices or deficiencies cited during any one survey; b.has more than three validated complaints in one licensed year period; c.has been issued a deficiency that involved placing a participant: i.at risk of serious harm; or ii.at risk for death; d.has failed to correct deficient practices: i.within 60 calendar days of being cited for such deficient practices; or ii.at the time of a follow-up survey; e.is not in substantial compliance at the time of renewal of the license with all applicable: i.federal, state, departmental, and local statutes, laws, ordinances, rules, regulations; and ii.fees. 5.When the department issues a provisional license to an existing licensed PACE provider, the department shall conduct an on-site follow-up survey at the PACE provider. The on-site follow-up survey shall be prior to the expiration of the provisional license. If that on-site follow-up survey determines that the PACE provider has corrected the deficient practices and has maintained compliance during the period of the provisional license, the department may issue a full license for the remainder of the year until the anniversary date of the PACE provider license. A provisional license may be extended at the discretion of the department. 6.If an existing licensed PACE provider has been issued a notice of license revocation, suspension, modification, or termination, and the PACE provider’s license is due for annual renewal, the department shall deny a license renewal subject to the pending license revocation, suspension, modification, or termination. The denial of renewal of such a license does not affect in any manner the: a.license revocation; b.suspension; c.modification; or d.termination. B.The denial of renewal of a license does not affect in any manner: 1.any sanction; 2.any civil monetary penalty; or 3.any other action imposed by the department against the PACE provider. C.The license for a PACE provider shall be valid for 12 months from the date of issuance unless: 1.revoked; 2.suspended; 3.modified; or 4.terminated prior to that time. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: §4313.Accredited Status A.After initial licensure, a PACE provider may request accreditation. To achieve accredited status, the PACE provider shall submit a copy of its current PACE program agreement and provide proof of meeting initial and continual compliance with PACE requirements and for each annual renewal of licensure. B.The department may accept accreditation in lieu of periodic on-site licensing surveys when the center provides documentation to the department that shows: 1.the PACE program agreement is current; and 2.the PACE provider remains in substantial compliance with all PACE program agreement requirements. C.The department may conduct unannounced complaint investigations on all PACE providers, including those with accredited status. D.There is no waiver of licensure fees for a PACE provider that is granted accredited status by the department. A PACE provider that is granted accredited status shall pay: 1.all initial licensing fees; 2.renewal of licensure fees pursuant to §4315; 3.any other required fees to achieve or maintain accredited status; and 4.any civil monetary penalties imposed by the department or may forfeit accredited status. E.The department may rescind accredited status and may conduct a licensing survey for the following: 1.any substantiated complaint within the preceding 12 months; 2.a CHOW; 3.issuance of a provisional license in the preceding 12-month period; 4.deficiencies identified in the preceding 12-month period that placed participants at risk of harm; 5.treatment or service resulting in death or serious injury; 6.a change in geographic location; or 7.when CMS issues any penalties or sanctions against the PACE provider. F.The PACE provider shall submit written notification to HSS upon change in accredited status. The notification shall be submitted within two business days of receiving notice of the changed accreditation status. G.The department shall rescind accredited status if the PACE provider’s program agreement is terminated. H.PACE providers that receive approval for accredited status are subject to and shall comply with all provisions of this Chapter. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: §4315.Renewal of License A.The licensee shall continue to be approved and enrolled as a PACE provider by CMS. This shall be a condition for renewal of license. B.At least 30 calendar days prior to the expiration of the current license, the PACE provider shall: 1.submit a completed PACE license renewal application on forms prescribed by the department; 2.include the days and hours of operation on the application; 3.submit a copy of the current on-site inspection report with approval for occupancy by the OSFM; 4.submit a copy of the current health inspection report from the OPH; 5.submit the required non-refundable license renewal fee as established by statute; a.A PACE provider shall be assessed a non-refundable delinquent fee as provided in R.S. 40:2120.68, or current law. The delinquent fee shall be for failure to timely renew its license. The assessed delinquent fee shall become due and payable to the department at 12:0l a.m. on the first day following the expiration date of the license; 6.proof of continuous financial viability, including: a.maintenance of a LOC that shall be: i.issued from a federally insured, licensed lending institution; and ii.in the amount of at least $50,000; b.compliance with the Louisiana Workers’ Compensation Law, R.S. 23:1020.1 et seq., or current law; and c.general and professional liability insurance of at least $300,000. 7.proof of PACE program agreement, if accredited; and 8.any other documentation or information required by the department for licensure renewal. C.The department shall determine if the PACE provider meets the requirements established herein. The following shall be submitted by the PACE provider: 1.the completed annual renewal application packet; 2.the annual non-refundable renewal fee; and 3.any applicable delinquent fee. D.To ensure compliance with the licensing standards established herein, the department may perform an on-site survey and inspection: 1.upon renewal of a license; and 2.at other reasonable times as necessary. E.If the provider continues to meet the requirements established herein, a license shall be issued. The license shall be valid for up to 12 months, unless otherwise revoked or suspended. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: §4317.Reporting Requirements A.Changes shall be reported in writing to the department within five working days of the occurrence. Changes shall include: 1.the name of the PACE provider; 2.the geographic or mailing address; 3.contact information (e.g., telephone number, fax number, or email address); or 4.key administrative staff (e.g., director, center manager, social worker, RN, etc.). B.Change of Ownership (CHOW) 1.The PACE license shall not be sold, transferred, or assigned. 2.A PACE provider may be sold, or its ownership may be transferred so long as it complies with all requirements in 42 CFR 460.60 and 42 CFR part 422, subpart L. For a CHOW, the new owner shall: a.notify the HSS in writing; and b.apply for a new license at least 45 business days prior to the effective date of the CHOW. 3.The transferor shall remain responsible for the operation of the PACE provider until a license has been issued to the transferee. 4.A signed copy of the legal transfer of ownership document shall be provided to HSS. 5.Within 45 business days of the effective date of the CHOW, the following shall be submitted: a.a CHOW application; and b.any other documents requested by HSS. 6.The new owner shall submit: a.a license application identifying all new information; and b.the appropriate CHOW non-refundable licensing fee. 7.A PACE provider shall not undergo a CHOW, if the PACE provider is under: a.license revocation; b.renewal of licensure; or c.provisional license. C.A CHOW of the PACE provider shall not be submitted at the time of annual renewal of the PACE provider’s license. D.A non-refundable fee shall be submitted when: 1.there’s a change in the license; or 2.a duplicate license has been requested. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: §4319.Denial of Initial Licensure, Revocation of License, Denial of License Renewal A.In accordance with the provisions of the Administrative Procedure Act (APA), the department: 1.may deny an application for an initial license or a license renewal; or 2.may revoke a license. B.Denial of an Initial License 1.The department shall deny an initial license if the initial licensing survey finds that the PACE provider applicant is noncompliant with any licensing laws or regulations, or any other required statutes or regulations that present a potential threat to the: a.health; b.safety; or c.welfare of the participants. 2.The department may deny an initial license for any of the reasons a license may be revoked or denied renewal pursuant to these licensing provisions. C.If a provider fails to renew its license timely, the license expires on its face. Once expired, the license is considered voluntarily surrendered. There are no appeal rights for such surrender or non-renewal of the license. This is a voluntary action on the part of the provider. D.Revocation of License or Denial of License Renewal 1.A PACE provider license may be revoked or denied renewal for any of the following reasons, including but not limited to: a.failure to be in substantial compliance with the PACE licensing: i.laws; ii.rules; and iii.regulations; b.failure to be in substantial compliance with other required: i.statutes; ii.laws; iii.ordinances; iv.rules; or v.regulations; c.failure to comply with the terms and provisions of a settlement agreement; d.failure to uphold participant rights whereby deficient practices result in: i.harm; ii.injury; or iii.death of a participant; e.failure to protect a participant from a harmful act of an employee, either contracted or staff, or by another participant including, but not limited to: i.mental or physical abuse; ii.neglect exploitation, or extortion; iii.any action posing a threat to a participant’s health and safety; iv.coercion; v.threat or intimidation; vi.harassment; or vii.criminal activity; f.failure to notify proper authorities, as required by federal or state law or regulations, of all suspected cases of acts outlined in §4317.D.; g.knowingly making a false statement in any of the following areas, including but not limited to: i.application for initial license or renewal of license; ii.clinical records, participant records, or provider records; iii.matters under investigation by the department or the Office of the Attorney General; or iv.information submitted for reimbursement from any payment source; h.knowingly making a false statement or providing false, forged, or altered information or documentation: i.to LDH employees; or ii.to law enforcement agencies; i.using false, fraudulent, or misleading advertising; or j.an owner, officer, member, manager, administrator, director, or person designated to manage or supervise participant care has pled guilty or nolo contendere to a felony, or has been convicted of a felony, as documented by a certified copy of the record of the court; i.for purposes of these provisions, conviction of a felony involves any felony conviction relating to: (a).the violence, abuse, or negligence of a person; (b).the misappropriation of property belonging to another person; (c).cruelty, exploitation, or the sexual battery of the infirmed; (d).a drug offense; (e).crimes of a sexual nature; (f).a firearm or deadly weapon; or (g).fraud or misappropriation of federal or state funds; k.failure to comply with all reporting requirements in a timely manner, as required by the department; l.failure to allow or refusal to allow the department to: i.conduct an investigation or survey; ii.interview provider staff or participants; or iii.have access to provider, facility, or participant records by authorized departmental personnel; m.interference with the survey process, including but not limited to: i.harassment; ii.intimidation; or iii.threats against the survey staff; n.failure to repay an identified overpayment to the department or failure to enter into a payment agreement to repay such overpayment; o.failure to timely pay to the department: i.outstanding fees; ii.fines; iii. sanctions; or iv.other debts; p.failure to maintain current, and in effect, required insurance policies in accordance with the provisions of this Chapter; or q.failure to: i.enter into a PACE program agreement; or ii.terminate the PACE program agreement. E.If a PACE provider license is revoked, renewal is denied, or the license is surrendered in lieu of an adverse action, any owner, board member, director, or administrator, or any other person named on the license application of such PACE provider shall be prohibited from owning, managing, directing, operating another PACE provider for a period of two years. The two-year period begins on the date of the final disposition of the: 1.revocation; 2.denial action; or 3.surrender. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: §4321.Notice and Appeal of Initial License Denial, License Revocation, and Denial of License Renewal A.Notice of the following shall be given to the provider in writing: 1.initial license denial; 2.license revocation; or 3.denial of license renewal. B.The PACE provider has a right to an administrative reconsideration (AR) of the initial license denial, license revocation, or denial of license renewal. There is no right to an AR of a voluntary non-renewal or surrender of a license by the provider. 1.The PACE provider shall request the AR within 15 calendar days of receipt of the notice of the initial license denial, license revocation, or denial of license renewal. The request for AR shall be in writing and shall be forwarded to the department’s HSS. The request for AR shall be considered timely if received by the HSS within 15 calendar days from the provider’s receipt of the notice. 2.The request for AR shall include any documentation that shows the determination was made in error. 3.If a timely request for an AR is received by HSS: a.an AR shall be scheduled; and b.the provider shall receive written notification of the date of the AR. 4.The provider shall have the right to: a.appear in person at the AR; and b.be represented by counsel. 5.Correction of a violation or deficiency that is the basis for the initial license denial, revocation, or denial of license renewal shall not be a basis for reconsideration. 6.The AR process is not in lieu of the administrative appeals process. 7.The provider shall be notified in writing of the results of the AR. C.The PACE provider has a right to an administrative appeal (AA) of the initial license denial, license revocation, or denial of license renewal. There is no right to an AA of a voluntary non-renewal or surrender of a license by the PACE provider. 1.The PACE provider shall request the AA within 30 calendar days of receipt of the results of the AR. a.The PACE provider may forego its rights to an AR, and if so, shall request AA within 30 calendar days of receipt of the written notice of the initial license: i.denial; ii.revocation; or iii.denial of license renewal. 2.The request for AA shall be in writing. The request shall be submitted to the Division of Administrative Law (DAL), or its successor. The request shall include: a.any documentation that shows the determination was made in error; and b.the basis and specific reasons for the appeal. 3.If a timely request for an AA is received by the DAL, or its successor, the AA of the initial license denial, license revocation, or denial of license renewal shall be suspensive. The provider shall be allowed to continue operations and provide services until such time as the department issues a final administrative decision. a.If the secretary of the department determines that the violations of the provider pose an imminent or immediate threat to the health, welfare, or safety of a participant, the imposition of the license revocation or denial of license renewal may be immediate and may be enforced during the pendency of the AA. If the secretary of the department makes such a determination, the provider shall be notified in writing. 4.Correction of a violation or a deficiency that is the basis for the initial license denial, license revocation, or denial of license renewal shall not be a basis for an AA. D.If an existing licensed PACE provider has been issued a notice of license revocation and the provider’s license is due for annual renewal, the department shall deny the license renewal application. The denial of the license renewal application does not affect, in any manner, the license revocation. E.If a timely AA has been filed by the provider on an initial license denial, denial of license renewal, or license revocation, the DAL, or its successor, shall conduct the hearing in accordance with the APA. 1.If the final decision of the DAL, or its successor, is to reverse the initial license denial, denial of license renewal, or license revocation, the provider’s license shall be re-instated or granted upon the payment of any licensing fees, outstanding sanctions, or other fees due to the department. 2.If the final decision of the DAL, or its successor, is to affirm the initial license denial, denial of license renewal, or license revocation, the provider shall ensure a safe and orderly discharge of any and all participants receiving services according to the provisions of this Chapter. a.Within 10 calendar days of the final decision of the DAL, or its successor, the provider shall notify HSS, in writing, of: i.the secure and confidential location where the participant records shall be stored; and ii.the name and contact information of the person(s) responsible for the participant records. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: §4323.Complaint Surveys A.The department shall conduct complaint surveys in accordance with R.S. 40:2009.13 et seq., or current law. B.Complaint surveys shall be unannounced surveys. C.A follow-up survey may be conducted for any complaint survey where deficiencies have been cited. D.The department may issue appropriate sanctions for deficiencies and noncompliance with any complaint survey, including, but not limited to: 1.civil monetary penalties; 2.directed plans of correction; and 3.license revocations. E.During any complaint survey, LDH surveyors and staff shall: 1.be given access to all areas of the center and all relevant files; and 2.be allowed to interview any PACE center staff and participants as required to conduct the survey. F.The PACE provider shall cooperate in all surveys or investigations conducted by the department. Failure to cooperate with the survey or investigation may result in action up to and including license revocation. G.The department may assess a PACE provider with a survey or investigation fee. The fee shall be in accordance with R.S. 40:2120.69, or current law for any complaint survey or investigation conducted by the department at which deficiencies are substantiated. 1.This survey or inspection fee shall be imposed by the department only after the: a.PACE provider has completed the administrative process that has upheld the deficiencies; or b.the time for filing any administrative process or appeal has expired. 2.The survey or investigation fee shall: a.not exceed the cost of performing the survey or inspection; and b.be in addition to any other sanctions. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: §4325.Statement of Deficiencies (SOD) A.The following SOD issued by the department to the PACE provider shall be posted visibly in a public area of the PACE center: 1.the most recent annual survey SOD; and 2.any subsequent complaint SOD. B.Any SOD issued by the department to a PACE provider shall be available for disclosure to the public: 1.30 calendar days after the PACE provider submits an acceptable POC to the deficiencies; or 2.90 calendar days after the SOD is issued to the PACE provider, whichever occurs first. C.Unless otherwise provided in statute or in these licensing provisions, a PACE provider shall have the right to an informal dispute resolution (IDR). This right applies to any deficiencies cited because of a survey or investigation. 1.Correction of the violation, noncompliance, or deficiency shall not be the basis for the reconsideration. 2.The IDR shall be submitted in writing within 10 calendar days of the PACE provider’s receipt of the SOD, unless otherwise provided within these standards. 3.The request for IDR shall be made to HSS. The request shall be considered timely if received by HSS within 10 calendar days of the PACE provider’s receipt of the statement of deficiencies. 4.The department shall schedule and conduct the IDR. Informal reconsiderations of the results of a complaint investigation are conducted as desk reviews. 5.The PACE provider shall be notified in writing of the results of the IDR. 6.The decision of the IDR team shall be the final administrative decision regarding the deficiencies except: a.as provided for complaint surveys pursuant to R.S. 40:2009.13 et seq., or current law; and b.as provided in these licensing provisions for initial license denials, revocations, and denial of license renewals. 7.The request for an IDR cited because of a survey or investigation, does not delay submission of the required POC within the prescribed timeframe. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: §4327.Cessation of Business A.Except as provided in §4329 and §4331 of these licensing regulations, a license shall be immediately null and void if a PACE provider becomes non-operational. B.A cessation of business (COB) is deemed to be effective: 1.the date on which the PACE provider ceased offering or providing services to the community; and/or 2.is considered non-operational in accordance with the requirements of §4305. C.Cessation of business is deemed to be a voluntary action on the part of the PACE provider. The PACE provider does not have a right to appeal a COB. D.Prior to the effective date of the closure or COB, the PACE provider shall: 1.give 30 calendar days advance written notice to: a.each participant or participant’s legal representative, if applicable; b.Health Standards Section; c.Office of Aging and Adult Services; and d.provide for a safe and orderly discharge and transition of all the PACE provider’s participants; 2.submit a written plan for the disposition of participant(s)’ medical records. a.The written plan shall be approved by the department and shall include the following: i.the effective date of the closure; ii.provisions for the closed PACE provider’s participant’s medical records. Provisions shall comply with federal and state laws on medical records: (a).storage; (b).maintenance; (c).access; and (d).confidentiality; iii.the name and contact information for the appointed custodian(s). The appointed custodian shall provide the following: (a).access to records and copies of records to the participant or authorized representative, upon presentation of proper authorization(s); and (b).physical and environmental security that protects the records against: (i).fire; (ii).water; (iii).intrusion; (iv).unauthorized access; (v).loss; and (vi).destruction; 4.public notice regarding access to records, which shall be: a.published in the newspaper with the largest circulation near the closing center; and b.given at least 15 calendar days prior to the effective date of closure. E.If a PACE provider fails to follow these procedures, the owners, managers, officers, directors, and administrators may be prohibited from opening, managing, directing, operating or owning a licensed PACE provider for a period of two years. F.Once any PACE provider has ceased doing business, the PACE provider shall not provide services. The PACE provider may resume providing services after obtaining a new initial PACE provider license. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: §4329.Inactivation of License due to a Declared Disaster or Emergency A.A PACE provider licensed in a parish that is the subject of an executive order or proclamation of emergency or disaster issued in accordance with R.S. 29:724 or current law, or R.S. 29:766 or current law, may seek to inactivate its license for a period not to exceed one year, provided that the following conditions are met. The licensed PACE provider shall: 1.submit written notification to HSS within 60 calendar days of the date of the executive order or proclamation of emergency or disaster that the licensed PACE provider: a.has experienced an interruption in the provisions of services because of events that are the subject of such executive order or proclamation of emergency or disaster issued in accordance with R.S. 29:724 or current law, or R.S. 29:766 or current law; b.intends to resume operation as a PACE provider in the same geographic service location; c.includes an attestation that: i.the emergency or disaster is the sole causal factor in the interruption of service provision; d.has properly discharged or transferred all participants to another PACE provider; and e.has provided a list of each participant and where that participant has been discharged or transferred to; 2.resume operating as a PACE provider in the same geographic service location within one year of the issuance of an executive order or proclamation of emergency or disaster in accordance with R.S. 29:724 or current law, or R.S. 29:766 or current law; 3.continue to submit to the department: a.all fees and costs due and owed to the department including, but not limited to: i.annual licensing fees; and ii.outstanding civil monetary penalties; b.all required annual licensing documentation and information. B.Upon receiving a completed written request to inactivate a PACE provider license, the department shall issue a notice of inactivation of license to the PACE provider. C.Upon completion of repairs, renovations, rebuilding, or replacement, a PACE provider that has received notice of inactivation of its license from the department shall be allowed to reinstate its license upon the following conditions being met. 1.The PACE provider shall: a.submit a written license reinstatement request to the licensing agency of the department; i.The license reinstatement request shall: (a).be submitted at least 60 days prior to the anticipated date of reopening; (b).inform the department of the anticipated date of opening; (c).include a completed licensing application with appropriate non-refundable fees; and b.request scheduling of a licensing survey. 2.The PACE provider resumes operating as a PACE provider in the same geographic service location within one year. D.Upon receiving a completed written request to reinstate a PACE provider license, the department shall conduct an onsite licensing survey. If the PACE provider meets the requirements for licensure and the requirements under this Section, the department shall issue a notice of reinstatement of the PACE provider license. 1.The licensed capacity of the reinstated license shall not exceed the licensed capacity of the PACE provider at the time of the request to inactivate the license. E.No CHOW in the PACE provider shall occur until such PACE provider has: 1.completed repairs, renovations, rebuilding, or replacement construction; and 2.resumed operations as a PACE provider. F.The provisions of this Section shall not apply to a PACE provider that has voluntarily surrendered its license and ceased operation. G.Failure to comply with any of the provisions of this Section shall be deemed a voluntary surrender of: 1.the PACE provider license; and 2.any applicable facility need review approval for licensure. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: §4331.Inactivation of License due to a Non-Declared Disaster or Emergency A.A licensed PACE provider in an area(s) that has been affected by a non-declared emergency or disaster may seek to inactivate its license. The following conditions shall be met. The licensed PACE provider shall: 1.submit written notification to HSS within 30 calendar days of the date of the non-declared emergency or disaster stating that the licensed PACE provider: a.has experienced an interruption in the provisions of services because of events that are due to a non-declared emergency or disaster; b.intends to resume operation as a PACE provider in the same geographic service location; c.attests that the non-declared emergency or disaster is the sole causal factor in the interruption of the provision of services; and d.initial request to inactivate does not exceed one year for the completion of: i.repairs; ii.renovations; iii. rebuilding; or iv.replacement of the PACE center; NOTE:Pursuant to these provisions, an extension of the 30-calendar day deadline for initiation of request may be granted at the discretion of the department. 2.continue to pay all fees and costs due and owed to the department including, but not limited to: a.annual licensing fees; and b.outstanding civil monetary penalties, and/or civil fines; and 3.continue to submit all required annual licensing documentation and information to the department. B.Upon receiving a completed written request to temporarily inactivate a PACE provider’s license, the department shall issue a notice of inactivation of license to the PACE provider. C.Upon the PACE provider’s receipt of the department’s approval of request to inactivate the PACE provider’s license, the PACE provider shall have 90 calendar days to submit plans for the repairs, renovations, rebuilding, or replacement of the PACE center, if applicable, to OSFM and OPH as required. D.The licensed PACE provider shall resume operating as a PACE provider in the same geographic service location within one year of the approval of renovation/construction plans by OSFM and OPH as required. EXCEPTION:If the PACE provider requires an extension of this timeframe due to circumstances beyond the PACE provider’s control, the department shall consider an extended time period to complete construction or repairs. Such written request for extension shall show the PACE provider’s active efforts to complete construction or repairs and the reasons for request for extension of PACE provider’s inactive license. Any approval for extension is at the sole discretion of the department. E.Upon completion of repairs, renovations, rebuilding, or replacement of the center, a PACE provider that has received notice of inactivation of its license from the department shall be allowed to reinstate its license upon the following conditions being met: 1.the PACE provider shall submit a written license reinstatement request to the licensing agency of the department; 2.the license reinstatement request shall: a.inform the department of the anticipated date of opening; b.request scheduling of a licensing or physical environment survey, where applicable; and c.include a completed licensing application with the required non-refundable licensing fees. F.Upon receiving a completed written request to reinstate a PACE provider license, the department may conduct an onsite survey. The survey may be an onsite licensing or physical environment survey. The department may issue a notice of reinstatement if the PACE provider has met the requirements for licensure including the requirements of this Section. G.No CHOW in the PACE provider shall occur until such PACE provider: 1.has completed repairs, renovations, rebuilding, or replacement construction; and 2.has resumed operations as a PACE center. H.The provisions of this Section shall not apply to a PACE provider that has: 1.voluntarily surrendered its license; and 2.ceased operation. I.Failure to comply with any of the provisions of this Section shall be deemed a voluntary surrender of the PACE provider license. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: Subchapter B.Administration and Organization §4337.Governing Body A.The PACE provider shall have an identifiable governing body. The governing body shall be responsible for and have authority over the policies and activities of the center. 1.The PACE provider shall have documents identifying the following information regarding the governing body: a.names and addresses of all members; b.terms of membership, if applicable; c.officers of the governing body, if applicable; and d.terms of office of all officers, if applicable. 2.When the governing body is composed of more than one-person, formal meetings shall be held at least twice a year. 3.The governing body shall have by-laws specifying frequency of meetings. The by-laws shall also specify quorum requirements. 4.The PACE provider shall have written minutes of all formal meetings of the governing body. 5.The PACE provider shall be operating under the control of an identifiable governing body (for example, a board of directors) or a designated person functioning as a governing body with full legal authority and responsibility. At least twice a year, the PACE provider shall have documentation of reviewing and meeting the requirements pursuant to §4337.B. B.Governing Body Responsibilities. The governing body of a PACE provider shall: 1.ensure governance and overall operation of the PACE provider; 2.ensure the PACE provider’s continual compliance and conformity with all relevant federal, state, parish, and municipal laws and regulations. These shall include but not be limited to: a.preventing; b.responding to; c.reporting; and d.mitigating instances of healthcare workplace violence; 3.ensure the PACE provider is adequately funded and fiscally sound; 4.review and approve the PACE provider’s annual budget; 5.ensure that considering the nature of the program, the PACE provider is appropriately: a.housed; b.maintained; c.staffed; and d.equipped; 6.designate a person to act as the program director and delegate sufficient authority to this person to: a.manage the center; and b.ensure that all services provided are consistent with accepted standards of practice; 7.annually evaluate the program director's performance; 8.have the authority to dismiss the program director; 9.formulate and review annually, in consultation with the program director, written policies concerning: a.the PACE provider’s: i.philosophy; ii.mission; iii.goals; iv.current services; v.personnel practices; and vi.fiscal management; and b.participant health and safety, including a comprehensive, systemic operational plan to ensure the participant's: i.health; ii.safety; and iii.welfare. 10.meet with designated representatives of the department whenever required to do so; 11.inform OAAS prior to initiating any substantial changes in the center’s program or services; 12.inform OAAS and the department’s HSS prior to initiating any substantial change in the physical plant; 13.ensure statewide criminal background checks on all non-licensed and contracted persons providing direct care and services to participants in accordance with R.S. 40:1203.1 et seq., or current law, or other applicable law upon hire; and 14.ensure that the provider does not hire or enter into a contractual agreement with non-licensed persons that have a conviction that bars employment in accordance with R.S. 40:1203.1 et seq., or current law, or other applicable state law; a.The provider shall maintain documentation on the final disposition of all charges that bars employment pursuant to applicable state law. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: §4339.Quality Improvement A.A PACE provider shall develop, implement, maintain, and evaluate an effective, data-driven quality improvement program (QIP). The QIP shall meet the requirements of the PACE program agreement. B.The QIP shall reflect the full range of services furnished by the PACE provider. C.A PACE provider shall take actions that result in improvements in its performance in all types of care. D.A PACE provider shall meet external quality assessment and reporting requirements, as specified by CMS or LDH. The requirements shall be in accordance with the PACE program agreement requirements. E.A PACE provider shall have a written QIP that is collaborative and interdisciplinary in nature. The QIP shall meet the PACE program agreement requirements. F.The PACE governing body shall review the QIP annually and revise it, if necessary. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: §4341.Policy and Procedures A.A PACE provider shall have written policies and procedures approved by the governing body. Written policies and procedures shall at a minimum address the following: 1.safeguarding all data, documents, and records against: a.loss; b.destruction; c.unauthorized use and access; or d.inappropriate alteration; 2.confidentiality of health information; 3.retention of records; 4.participant’s rights; 5.grievance procedures; 6.emergency preparedness; 7.abuse and neglect; 8.incidents and accidents; 9.medication administration; 10.smoking; 11.infection control, including at least the standard precautions developed by the Centers for Disease Control and Prevention (CDC); 12.statewide criminal history background checks; 13.checks of the Louisiana certified nurse aide registry (LCNAR), the Louisiana adverse actions list (LAAL), and the Office of Inspector General’s (OIG) List of Excluded Individuals/Entities (LEIE), These checks shall be conducted upon hire and monthly thereafter. These checks are necessary to determine if there is a finding that a prospective hire or currently employed or contracted non-licensed person has been determined to have committed. A finding includes exploitation, extortion, abuse, or neglect of an individual in the care of the non-licensed person, or if there has been misappropriation of the individual’s property or funds. If there is such a finding on the LCNAR, the LAAL, or the OIG LEIE, the prospective non-licensed person shall not be hired as a certified nurse aide (CNA) or direct service worker (DSW), nor shall a current or contracted employee have continued employment as a CNA or DSW with the PACE provider; 14.the process for participants to file a grievance with the center and/or register a complaint with the department. a.The LDH toll-free telephone number for registering complaints shall be posted visibly in public areas of the PACE center; 15.the reporting of abuse, neglect, extortion, or exploitation of participants pursuant to the provisions of R.S. 15:1504-1505, R.S. 40:2009.20, and any subsequently enacted laws. Providers shall ensure that staff comply with these regulations; 16.any other area required in accordance with memorandums issued by the department’s HSS, OAAS, and CMS. B.A PACE provider shall have personnel policies approved by the governing body that include: 1.orientation for each employee and all contracted persons that includes, at a minimum: a.the provider’s mission, philosophy, policies on participant’s rights, emergency plan, ethics, the PACE benefit; and b.any policies related to job duties of specific staff; 2.written job descriptions for each employee and all contracted staff; 3.a risk assessment in accordance with 42 CFR Part 460; 4.abuse and neglect reporting procedures that require all employees to report any incidents of abuse or neglect in accordance with state law, whether the abuse or mistreatment is committed by: a.another staff member; b.a family member; or c.any other person; 5.that all persons, either contracted or directly employed, receive training relative to the restrictive use of social media and include, at a minimum: a.ensuring confidentiality of participant information; and b.preservation of participant dignity and respect, including protection of participant privacy and personal and property rights; and 6.discrimination. C.Policies and procedures shall be revised as needed. Policies and procedures shall be reviewed by the PACE provider’s key personnel at least annually. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: §4343.Administrative Records A.A PACE provider shall have administrative records that include: 1.documents identifying the governing body including: a.a list of the officers and members of the governing body; b.the officers and members’ contact information, including but not limited to: i.physical address; ii.email address; iii.telephone number; and c.the terms of the governing body’s membership, if applicable; 2.by-laws of the governing body and minutes of formal meetings, if applicable; 3.documentation of the PACE provider's authority to operate under state law; 4.an organizational chart for the PACE provider; 5.all leases, contracts, and purchase-of-service agreements to which the PACE provider is a party; 6.insurance policies; 7.annual budgets and audit reports; and 8.a master list of all contracted programs and services used by the PACE provider. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: §4345.Participant Medical Records A.Maintenance of participant medical records. 1.A PACE provider shall maintain a single, comprehensive medical record for each participant. The medical record shall be in accordance with accepted professional standards. 2.The medical record for each participant shall meet the following requirements: a.be complete; b.be accurately documented; c.be readily accessible; d.be systematically organized; e.be available to all staff, as appropriate; and f.be maintained and housed at the PACE center where the participant receives services. B.At a minimum, the medical record shall contain the following: 1.appropriate identifying information; 2.documentation of all services furnished, including the following: a.a summary of emergency care and other inpatient or long-term care services; and b.services furnished by employees and/or contractors of the PACE center; 3.interdisciplinary team assessments, reassessments, plans of care, treatment, and progress notes that include the participant's response to treatment; 4.all recommendations for services made by employees or contractors of the PACE provider, including specialists; 5.documentation that a service recommended by an employee or contractor of the PACE provider, including a specialist, is not approved or provided. Documentation shall include the reason(s) for not approving or providing that service; 6.original documentation, or an unaltered electronic copy, of any written communication as described in 42 CFR 460.200(d)(2), unless the following requirements are met: a.the medical record contains a thorough and accurate summary of all relevant communication; b.original documentation of the communication is maintained outside of the medical record. Original documentation shall be accessible by employees and contractors of the PACE provider: i.when necessary; and ii.in accordance with 42 CFR 460.200(e); and c.original documentation of the communication is available to CMS and the department upon request; 7.laboratory, radiological, and other test reports; 8.medication records; 9.hospital discharge summaries, if applicable; 10.reports of contact with informal support (for example, caregiver, legal guardian, or next of kin); 11.enrollment agreement; 12.primary care provider orders; 13.discharge summary and disenrollment justification, if applicable; 14.advance directives, if applicable; and 15.a signed release permitting disclosure of personal information. C.The PACE provider shall promptly transfer copies of appropriate sections of the medical record between treatment facilities. D.Authentication of medical records 1.All entries shall be: a.legible; b.clear; c.complete; and d.appropriately authenticated and dated. 2.Authentication shall include signatures or a secured computer entry by a unique identifier of the primary author who has reviewed and approved the entry. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: §4347.Retention of Records A.A PACE provider shall retain records for the longest of the following periods: 1.the period of time specified in state law; 2.10 years from the last entry date; or 3.for medical records of disenrolled participants, 10 years after the date of disenrollment. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: §4349.Confidentiality and Security of Records A.A PACE provider shall do the following: 1.establish written policies and implement procedures to safeguard all data, documents, and records against: a.loss b.destruction; c.unauthorized use; or d.inappropriate alteration; 2.maintain all written communications received in any format (for example, emails, faxes, letters, etc.) from participants or other parties in their original form when the communications relate to a participant's care, health, or safety. This includes but is not limited to the following: a.communications from the participant, his or her designated representative, a family member, a caregiver, or any other individual who provides information pertinent to a participant's: i.health; ii.safety; or iii.welfare; or b.communications from an advocacy or governmental agency such as Adult Protective Services. B.Confidentiality of Health Information 1.A PACE provider shall establish written policies and implement procedures to do the following: a.safeguard the privacy of any information that identifies a particular participant; i.Information from or copies of records may be released only to authorized individuals. ii.The original medical records shall be released only in accordance with: (a.)federal or state laws; (b.)court orders; or (c.)subpoenas; b.maintain complete records and relevant information in an accurate and timely manner; c.grant each participant: i.timely access, upon request, to review; and copy his or her own medical records; and ii.to request amendments to those records; and d.abide by all federal and state laws regarding confidentiality and disclosure of: i.mental health records; ii.medical records; and iii.other participant health information. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: Subchapter C.Participant Rights §4353.Statement of Rights A.A PACE provider shall have a written participant bill of rights (PBR). The PBR shall be designed to protect and promote the participants' rights. The PBR shall include at a minimum: 1.explanation of rights; 2.protection of rights; 3.right to treatment; 4.respect and nondiscrimination; 5.information disclosure; 6.choice of providers; 7.participation in treatment decisions; 8.confidentiality of health information; 9.complaints, requests, appeals; and 10.LDH HSS complaint telephone number. B.Each PACE participant shall be informed of his or her rights and responsibilities regarding the PACE provider. The regulations of the PACE provider and all rules governing participant conduct and behavior shall be fully explained to the participant. Before or upon enrollment, the PACE provider shall provide the participant with a copy of the PBR. A copy of the PBR shall be available in large print for those with vision impairments. A signed and dated written acknowledgment of the PBR shall be filed in each participant's record. C.If the PACE provider changes its PBR policies, a signed and dated acknowledgment shall be filed in each participant's record. D.Explanation of Rights 1.Written Policies. A PACE provider shall have written policies and implement procedures to ensure that the participant, his or her representative, if any, and staff understand these rights. 2.Explanation of Rights. The PACE provider shall fully explain the rights to the participant and his or her representative, if any, at the time of enrollment. The explanation shall be understood by the participant. 3.Display. The PACE provider shall meet the following requirements: a.write the participant rights in English, and in any other principal languages of the community, as determined by statute. In the absence of a state standard, the principal language of the community shall be any language that is spoken by at least five percent of the participants in the PACE provider's geographic service location; and b.display the PACE participant rights visibly in a public area of the PACE center. E.The PACE provider shall have a written policy on participant's civil rights. This policy shall give assurances that: 1.a participant's civil rights are not changed or voided solely because of placement in the PACE provider’s program; and 2.a participant is not denied enrollment, segregated into programs or otherwise subjected to discrimination based on: a.race; b.ethnicity; c.national origin; d.religion; e.sex; f.age; g.mental or physical disability; h.sexual orientation; or i.source of payment. F.The participant rights document shall include at least the following items: 1.the right to be informed in writing, of: a.all services available through the PACE provider; b.the charges for those services; and c.the PACE provider’s days and hours of operation; 2.the right to participate in each IDT staffing meeting and any other meeting involving the care of the participant; 3.the right to refuse any service provided at the PACE center; 4.the right to present complaints or recommend changes regarding the PACE provider’s policies and services to staff or to outside representatives without fear of: a.restraint; b.interference; c.coercion; d.discrimination; or e.reprisal; 5.the right to be free from mental, physical, or verbal abuse; 6.the right to be free from coercion; 7.the right to be free from restraints, except when determined by the PACE provider’s IDT; 8.the right to privacy during the provision of personal needs services; 9.the right to communicate, associate, and meet privately with individuals of his or her choice, unless this infringes on the rights of another participant; and 10.the right not to be required to perform services for the PACE provider, except when the performance of a specific service is identified in the CPSP as an appropriate approach to meeting the needs of the participant. G.A friendly, supportive, comfortable, and safe atmosphere shall always be maintained. All participants shall be treated equitably with: 1.respect; 2.kindness; and 3.patience. H.Each participant shall be encouraged and assisted in exercising his or her rights as: 1.a participant at the PACE center; and 2.as a citizen. I.If the participant's rights have been transferred to the personal representative or next of kin, that party shall receive the explanation of and sign the participant rights and any other documents described in these standards. Under the following conditions, the PACE provider shall ensure that participant rights are transferred to the personal representative or next of kin. 1.The participant has been interdicted in a court of law. In such cases, the PACE provider shall ensure that the participant's rights transfer to the curator or curatrix of record. The PACE provider shall obtain a legal judgment of interdiction verifying that the participant is currently interdicted. a.The interdiction shall be documented on the inside front cover of the participant's record. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: §4355.Grievances A.A PACE provider shall have a formal written process to promptly identify, document, investigate, and resolve all medical and non-medical grievances. The process shall be in accordance with the requirements in this part. B.Upon enrollment, and at least annually thereafter, the PACE provider shall give a participant written information on the grievance process. The information shall be in understandable language, including all the following: 1.that any of the following individuals have the right to voice grievances without discrimination or reprisal, and without fear of discrimination or reprisal: a.the participant; b.the participant’s family member; c.the participant’s designated representative; or d.the participant’s caregiver. 2.that the following methods may be utilized for submitting a grievance: a.A grievance may be filed with the PACE provider either orally or in writing. b.The PACE provider may not require a written grievance to be submitted on a specific form. c.A grievance may be made to any employee or contractor of the PACE provider that provides care to a participant: i.in the participant's residence; ii.in the PACE center; or iii.while transporting participants. C.The PACE provider shall conduct a thorough investigation of all distinct issues within the grievance. This shall occur when the cause of the issue is not already known. D.The PACE provider shall do the following: 1.Take action to resolve the grievance based on the results of its investigation. Action shall be taken as quickly as the case requires. Action shall be no later than 30 calendar days after the date the PACE provider receives the oral or written grievance. 2.Notify the individual who submitted the grievance of the grievance resolution. Notification shall occur as quickly as the case requires. Notification shall be no later than three calendar days after the date the PACE provider resolves the grievance. E.The PACE provider shall inform the individual who submitted the grievance of the resolutions follows: 1.either orally or in writing, based on the individual's preference for notification; 2.at a minimum, oral or written notification of grievance resolutions shall include the following, if applicable: a.a summary statement of the individual's grievance including all distinct issues; b.a summary of the pertinent findings or conclusions regarding the concerns for each distinct issue that requires investigation; and c.for a grievance that requires corrective action, the corrective action(s) taken are to be taken by the PACE provider because of the grievance, and when the individual may expect corrective action(s) to occur; 3.all grievances related to quality of care, regardless of how the grievance is filed, shall be responded to in writing; 4.the PACE provider may withhold notification of the grievance resolution if: a.the individual who submitted the grievance specifically requests not to receive the notification; and b.the PACE provider has documented this request in writing. The PACE provider is still responsible for Paragraphs E.1.-3 of this Subsection. F.The PACE provider shall continue to furnish all required services to the participant during the grievance process. G.The PACE provider shall develop and implement procedures to maintain the confidentiality of grievances. The procedures shall include protecting the identity of all individuals involved in grievances from other employees and contractors when appropriate. H.The PACE provider shall establish and implement a process to document, track, and maintain records related to all processing requirements for grievances. Grievances may be received both orally and in writing. These records, except for information deemed confidential as a part of Subsection G of this Section, shall be available to the IDT to ensure that all members remain alert to pertinent participant information. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: §4357.Restraints A.The PACE provider shall limit use of restraints to the least restrictive and most effective method available. The term restraint includes either: 1.physical restraint; or 2.a chemical restraint. B.If the IDT determines that a restraint is needed to ensure the participant's physical safety or the safety of others, the use shall meet the following conditions: 1.be imposed for a defined, limited period of time, based upon the assessed needs of the participant; 2.be imposed in accordance with safe and appropriate restraining techniques; 3.be imposed only when other less restrictive measures have been found to be ineffective to protect the participant or others from harm; 4.be removed or ended at the earliest possible time; and 5.be imposed by qualified staff with documented training on the use of restraints in accordance with the PACE provider’s policies and procedures. C.The condition of the restrained participant shall be continually assessed, monitored, and reevaluated to ensure staff has continued competency in the use of restraints. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: Subchapter D.PACE Services §4361.PACE Services Delivery A.Access to Services 1.At a minimum, a PACE provider shall provide care that meets the needs of each participant. The care shall be in all care settings and 24 hours a day. The care shall be every day of the year. The PACE provider shall establish and implement a written plan to ensure that care is appropriately furnished. 2.PACE services shall only be provided in the approved geographic service location. B.Provision of Services 1.The PACE provider shall furnish comprehensive medical, health, and social services that integrate acute and long-term care. 2.PACE services shall be provided: a.in the PACE center; b.in the home; or c.in the community. 3.The PACE provider may not discriminate against any participant in the delivery of required PACE services based on: a.race; b.ethnicity; c.national origin; d.religion; e.sex; f.age; g.mental or physical disability; h.sexual orientation; or i.source of payment. 4.The PACE provider shall document, track, and monitor the provision of services across all care settings. Such action shall ensure that regardless of whether services are part of the participant's plan of care, the IDT remains alert to the participant's: a.medical needs; b.physical needs; c.emotional needs; and d.social needs. C.Timeframes for Arranging and Providing Services 1.The PACE provider shall arrange and schedule the dispensing of medications as quickly as the participant's condition requires. Dispensing shall occur no later than 24 hours after a primary care provider orders the medication. 2.The PACE provider shall arrange or schedule the delivery of IDT approved services, other than medications, as identified in Clauses C.2.a.i.-iv of this Subsection, as quickly as the participant's health condition requires. Services shall be delivered no later than seven calendar days after the date the IDT or member of the IDT first approves the service. Exceptions are identified in Subparagraphs C.3.a.-c of this Subsection. a.IDT approved services include: i.services approved by the full IDT; ii.services approved by a member of the IDT; iii.services ordered by a member of the IDT; and iv.care planned services. 3.Routine or preventative services are excluded from the requirement in Paragraph C.2 of this Section when all the following requirements are met: a.the PACE provider documents that they were unable to schedule the appointment due to circumstances beyond the control of the PACE provider; b.the participant does not have a change in status that requires the service to be provided more quickly; and c.the PACE provider provides the service as quickly as the participant's condition requires. 4.Services shall be provided as quickly as the participant's health condition requires, considering: a.the participant's medical needs; b.the participant’s physical needs; c.the participant’s social needs; and d.the participant’s emotional needs. D.At a minimum, the following services shall be furnished at each PACE center: 1.primary care, including services furnished by a primary care provider and nursing services; 2.social services; 3.restorative therapies, including physical therapy and occupational therapy; 4.personal care and supportive services; 5.nutritional counseling; 6.recreational therapy; and 7.meals. E.PACE Center Operation 1.A PACE provider shall operate at least one PACE center in its defined geographic service location listed on the license. Operation shall be sufficient capacity to allow routine attendance by participants. 2.A PACE provider shall ensure accessible and adequate services to meet the needs of its participants. If necessary, a PACE provider shall increase the number of: a.PACE centers; b.PACE staff; or c.other PACE services. 3.If a PACE provider operates more than one center, each PACE center shall: a.offer the full range of services; and b.have sufficient staff to meet the needs of participants. F.The frequency of a participant's attendance at a center is determined by the IDT. The frequency is based on the participant's needs and preferences. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: §4363.Contracted Services A.General Rule. The PACE provider shall have a written contract with each outside entity, agency, or individual that furnishes administrative or care-related services not furnished directly by the PACE provider. At a minimum, the following medical specialties shall be included: 1.anesthesiology; 2.audiology; 3.cardiology; 4.dentistry; 5dermatology; 6.gastroenterology; 7.gynecology; 8.internal medicine; 9.nephrology; 10.neurosurgery; 11.oncology; 12.ophthalmology; 13.oral surgery; 14.orthopedic surgery; 15.otorhinolaryngology; 16.palliative medicine; 17.plastic surgery; 18.pharmacy consulting services; 19.podiatry; 20.psychiatry; 21.pulmonology; 22.radiology; 23.rheumatology; 24.general surgery; 25.thoracic and vascular surgery; and 26.urology. B.Contracts with medical specialists shall be executed prior to enrollment of participants. The contracts shall be maintained on an ongoing basis to ensure participants receive appropriate and timely access to all medically necessary care and services. C.A contract with the PACE provider shall comply with the requirements of R.S.40:2120.66 C, or current law. The contract shall also comply with the following requirements: 1.Any contracts with the PACE provider shall: a.meet all applicable federal and state requirements including, but not limited to: i.hospital services; ii.nursing facility services; or iii.hospice services; b.meet Medicare or Medicaid participation requirements; c.meet Medicare or Medicaid requirements applicable to the services furnished by any practitioner or supplier; and d.comply with service delivery, participants and quality improvement activities. 2.A contractor shall be accessible to participants, located either within or near the PACE provider’s geographic service location. 3.A PACE provider shall designate an official contact person to coordinate activities between: a.contractors; and b.the PACE provider. 4.Each contract shall be in writing and include the following: a.name of contractor; b.services furnished; c.payment rate and method; and d.terms of the contract, including: i.beginning and ending dates; and ii.methods of extension, renegotiation, and termination. 5.A current list of contractors shall be kept on file at the PACE provider. The contractor list shall be provided to anyone upon request. The PACE provider shall ensure that all contractors meet the requirements of R.S. 40:2120.66, or current law. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: §4365.Nutrition Services A.The PACE center shall ensure, through the assessment and care planning process, that each participant receives nourishing, palatable, well-balanced meals at the PACE Center. The meals shall meet the participant's daily nutritional and special dietary needs. Each meal shall meet the following requirements: 1.be prepared by methods that conserve nutritive value, flavor, and appearance; 2.be prepared in a form designed to meet individual needs; and 3.be prepared and served at the proper temperature. B.The PACE center shall provide substitute foods or nutritional supplements that meet the daily nutritional and special dietary needs of any participant who: 1.refuses the food served; or 2.cannot tolerate the food served. C.The PACE provider shall provide nutritional support to meet the daily nutritional needs of a participant, if indicated by his or her medical condition or diagnosis. Nutrition support consists of: 1.tube feedings; 2.total parenteral nutrition; or 3.peripheral parenteral nutrition. D.Drinking water shall be readily available. If a water fountain is not available, single-use disposable cups shall be used. E.Food preparation and/or serving areas and utensil cleaning procedures shall comply with the State Sanitary Code. The PACE center shall do the following, in accordance with the State Sanitary Code: 1.procure foods (including nutritional supplements and nutrition support items) from sources approved, or considered satisfactory, by Federal, State, Tribal, or local authorities with jurisdiction over the geographic service location of the PACE provider; 2.store, prepare, distribute, and serve beverages and foods (including nutritional supplements and nutrition support items); 3.keep utensils clean and sanitary; and 4.dispose of garbage. F.The PACE provider’s refrigerator(s) shall be maintained at a temperature of 41 degrees Fahrenheit or below. The PACE provider shall maintain daily temperature logs for all refrigerators and freezers. Any food stored in the refrigerator shall be covered, labeled, and dated. G.Menus shall provide a variety of nutritional foods. Menus shall be planned and approved well in advance by a licensed registered dietician. H.A licensed registered dietitian shall: 1.review all primary care providers' orders for special diets; 2.prepare menus as needed; and 3.provide in-service training to staff and, as appropriate, participants. I.Documentation shall be available in the participant’s case record of: 1.any participant meal substitutions; 2.any refusal of meals; 3.any food allergies; and 4.any recommendations from the licensed dietician. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: §4367.Transportation Services A.A PACE provider's transportation services shall be: 1.safe; 2.accessible; and 3.equipped to meet the needs of the participant population. B.All vehicles shall be maintained as follows: 1.If the PACE provider owns, rents, or leases transportation vehicles, it shall maintain these vehicles in accordance with the manufacturer's recommendations. 2.If a contractor provides transportation services, the PACE provider shall ensure that the vehicles are maintained in accordance with the manufacturer's recommendations. C.The PACE provider shall have liability insurance coverage and shall have proof of such coverage. D.The PACE provider and any contracted transportation company shall conform to all state and/or local laws and regulations pertaining to: 1.drivers; 2.vehicles; and 3.insurance. E.The PACE provider shall ensure that transportation vehicles are equipped to communicate with the PACE center. F.The PACE provider shall train all transportation personnel (employees and contractors). Said training shall include managing the special needs of participants. G.There shall be at least one staff member in the vehicle who is trained in first aid and cardiopulmonary resuscitation (CPR) whether transportation is provided: 1.by center-owned transportation; or 2.by a third-party commercial proprietor. H.The driver, whether directly employed or provided by third-party contract, shall hold a valid chauffeur’s license or commercial driver license (CDL), if applicable with passenger endorsement. I.The number of occupants allowed in a car, bus, station wagon, van, or any other type of transportation shall not exceed the number for which the vehicle is designed. J.Provisions shall be made to accommodate participants who use assistive devices for walking. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: Subchapter E.Human Resources §4371.Personnel Policies A.A PACE provider shall have personnel policies that include: 1.a written plan for recruitment, screening, orientation, in-service training, staff development, supervision and performance evaluation of all staff members; 2.a written job description for each staff position, including volunteers; 3.a health assessment that includes, at a minimum, evidence that the employee is free of active tuberculosis. Staff shall be retested on a time schedule as mandated by the Office of Public Health. The health assessment shall also include any other required medical examinations. All staff shall be medically cleared of any communicable diseases before engaging in direct participant contact; a.Policies shall be in accordance with state rules, laws, and regulations for employees, either contracted or directly employed, and volunteers. 4.a written employee grievance procedure; 5.abuse and neglect reporting procedures that require all employees to report any incidents of abuse or neglect in accordance with state law, whether the abuse or mistreatment is committed by another staff member, a family member or any other person; 6.clarification of the PACE provider’s prohibited use of social media. The policy shall ensure that all staff either contracted, directly employed, or volunteers, receive training on the restrictive use of social media. The training shall include, at a minimum: a.ensuring confidentiality of participant information; and b.preservation of participant dignity and respect, including protection of participant privacy, personal and property rights; 7.preventing discrimination; and 8.preventing, responding to, reporting, and mitigating instances of healthcare workplace violence in accordance with R.S. 40:2199.12(3), or current law. This requirement shall apply to those facilities that employ five or more licensed healthcare professionals. B.A PACE provider shall not discriminate in recruiting or hiring based on: 1.sex; 2.race; 3.creed; 4.national origin; or 5.religion. C.A PACE provider’s screening procedures shall address the prospective employee's qualifications, ability, related experience, health, character, emotional stability, and social skills as related to the appropriate job description. 1.Prior to making an offer of employment, a PACE provider shall: a.obtain written references from three persons; or b.prepare documentation based on telephone contacts with three persons. The names of the references and a signed release shall be obtained from the potential employee. 2.A PACE provider shall ensure checks of the LCNAR, the LAAL, and the OIG LEIE. These checks shall be prior to making an offer of employment or offer to contract with non-licensed DCS. The checks shall be performed monthly thereafter. 3.A PACE provider shall ensure that statewide criminal history background checks are performed on all unlicensed persons (including contractors) working for the PACE provider in accordance with R.S. 40:1203.1 et seq., or current law, and/or other applicable state law upon hire. a.A PACE provider shall ensure that they do not hire unlicensed persons who have a conviction that bars employment in accordance with R.S. 40:1203.3 and/or other applicable state law. i.The PACE provider shall maintain documentation on the final disposition of all charges that bar employment pursuant to applicable state law. 4.A PACE provider shall ensure that all employees, including contractors, are not excluded from participation in the Medicaid programs by checking the LCNAR, the LAAL, and OIG LEIE upon hire and then monthly thereafter. a.A PACE provider shall maintain documentation of the results of these database checks. D.A PACE provider shall complete an annual performance evaluation for all current staff, including contracted staff and volunteers. 1.For any person who interacts with participants, performance evaluation procedures shall address the: a.quality of staff member's interactions with participants; and b.nature of staff member's interactions with participants. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: §4373.Orientation and Training A.A provider’s orientation program shall provide training for all staff, either contracted, employed, or volunteers. The orientation program shall acquaint them with the philosophy, organization, program, practices and goals of the provider. The orientation shall also include instructions in: 1.safety; 2.emergency procedures; and 3.the specific responsibilities of the employee's job. B.All employees providing care and services shall have, at a minimum, documented completion of: 1.current cardiopulmonary resuscitation (CPR) certification; and 2.first aid training. C.The provider shall ensure that each direct care staff (DCS), either contracted or employed satisfactorily, completes a minimum of 20 hours of training. The training shall occur upon hire and before providing direct care and services to participants. Such training shall include the following topics and shall be documented, maintained and readily available in the provider’s records: 1.the provider’s policies and procedures; 2.emergency and safety procedures; 3.recognizing and responding to medical emergencies including: a.knowing when to make an immediate call to 911; and b.knowing how to support the participant while waiting for the emergency personnel to arrive such as: i.keeping an open airway for breathing; ii.checking for the presence of a pulse; or iii.stopping bleeding; 4.participant’s rights; 5.detecting and reporting suspected abuse and neglect; 6.reporting critical incidents; 7.universal precautions; 8.documentation; 9.implementing a participant’s plan of care; 10.confidentiality; 11.detecting signs of illness or impairment that warrant medical or nursing intervention; 12.basic skills required to meet the health needs of the participant; 13.the management of aggressive behavior, including acceptable and prohibited responses; 14.scald prevention training; and 15.completes a basic first aid course. D.A provider shall document that all employees, either contracted or staff, shall receive annual in-person training in: 1.the principles and practices of participant care; 2.the provider’s policies and procedures and programmatic goals; 3.emergency and safety procedures; 4.protecting the participant's rights; 5.procedures and legal requirements concerning the reporting of abuse and neglect; 6.acceptable behavior management techniques; 7.crisis management; and 8.prohibited use of social media. E.Each DCS shall complete 20 hours per year of in-person training to ensure continued competence. This training shall address the special needs of participants. This training may address areas of employee weakness as determined by DCS’ performance reviews. F.A new DCS employee shall not be assigned to carry out a participant’s care until such employee has had competency evaluation. G.Competency Evaluation 1.A competency evaluation shall be developed and conducted to ensure that, at a minimum, each DCS, either contracted or employed, is able to demonstrate competencies in the training areas as defined in §4373. 2.Written or oral examinations shall be provided. 3.The examination shall reflect the content and emphasis of the training curriculum components. The examination shall be developed in accordance with accepted educational principles. 4.The provider shall ensure that those DCS with limited literacy skills receive substitute examinations. The examination shall be sufficient to determine: a.written reading comprehension; and b.competency to perform duties assigned. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: §4375.Personnel Files A.In accordance with §4371, a PACE provider shall have a personnel file for each staff member that contains: 1.the application for employment and/or resume; 2.the statewide criminal history background; 3.documentation of checks of the LCNAR, the LAAL, and the OIG LEIE; 4.reference letters from: a.former employer(s) and personal references; or b.written documentation based on telephone contact with such references; 5.a copy of a physical examination report wherein staff have been medically cleared of communicable disease, or evidence that risk assessment has been performed to determine when a physical examination would be required for staff. This shall be completed prior to the employee providing direct care. All DCS shall be determined to be free of active tuberculosis disease; 6.evidence of applicable professional credentials and certifications according to state law; 7.annual performance evaluations; 8.personnel actions, other appropriate materials, reports and notes relating to the individual's employment with the PACE provider; 9.the employee’s starting and termination dates; and 10.evidence of required trainings. B.A PACE provider shall retain an employee’s personnel file for at least three years after the employee's termination of employment. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: Subchapter F.Center Responsibilities §4379.General Provisions A.A PACE provider shall employ enough qualified staff and delegate sufficient authority to such staff to ensure that the center's responsibilities are carried out and that the following functions are adequately performed: 1.administrative functions; 2.fiscal functions; 3.clerical functions; 4.housekeeping, maintenance, and food service functions; 5.direct service functions; 6.supervisory functions; 7.record-keeping and reporting functions; 8.social services functions; and 9.ancillary service functions. B.The PACE provider shall ensure that all staff members are properly certified and/or licensed as legally required. C.The PACE provider shall ensure that an adequate number of qualified direct service staff is present with the participants as necessary to ensure the health, safety, and well-being of participants. 1.Staff coverage at the PACE Center shall be maintained giving consideration to: a.the time of the day; b.the size and nature of the PACE center; and c.the needs of the participants. D.The PACE provider shall not knowingly hire, or continue to employ, any person whose health, educational achievement, emotional or psychological makeup impairs his or her ability to properly protect the health and safety of the participants or is such that it would endanger the physical or psychological well-being of the participants. 1.This requirement is not to be interpreted to exclude the continued employment of persons undergoing temporary medical or emotional problems unless such problems pose a threat to the health or safety of any participant or staff. E.If any required professional services are not furnished by center employees, the PACE provider shall have a written agreement with an appropriately qualified professional to perform the required service. F.The PACE provider shall establish procedures to ensure adequate communication among staff and to provide continuity of services to participants. This system of communication shall include: 1.a regular review of individual and aggregate concerns of participants, including actions taken to resolve these concerns; 2.sharing daily information, noting unusual circumstances and other information requiring continued action by staff; and 3.the maintenance of all accidents, personal injuries, and pertinent incident records related to implementation of the participant’s individual service plans. G.Any employee who is working directly with participant care shall have access to information from participant case records. This shall include information that is necessary for the effective performance of the employee's assigned tasks. H.The PACE provider shall establish procedures that facilitate participation and feedback by staff members in: 1.policymaking; 2.planning; and 3.program development for participants. I.At all times, there shall be a staff member in the center who: 1.has knowledge of and can apply first aid; and 2.who is certified in CPR. J.In the absence of the PACE center manager, an appropriate designee shall supervise the center. K.The PACE center shall not provide service to more participants than the OSFM approved capacity specified within the center on its license. This requirement shall be applicable: 1.on any given day; or 2.at any given time. L.The PACE provider shall make available to the department any information that the PACE center is required to have under these standards and is reasonably related to the assessment of compliance with these standards. The participant's rights shall not be considered abridged by this requirement. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: §4381.Staffing Requirements A.Administrative Staff 1.A program director at the licensed geographic location shall meet the qualifications as established in these provisions. The program director shall be responsible for the oversight and administration of the PACE provider. B.Program Director Qualifications 1.The program director shall have a high school diploma or equivalent. The program director shall meet the following requirements: a.have a bachelor’s degree, plus a minimum of four years of verifiable experience working in the fields of health, social services, geriatrics, management or administration providing services to the elderly; or b.in lieu of a bachelor’s degree, eight years of administrative experience working in the fields of health, social services, geriatrics, management or administration providing services to the elderly; or c.a master’s degree in geriatrics, social services, geriatrics, management or administration; or d.be a licensed nursing facility administrator. C.Program Director Responsibilities. The program director shall: 1.be employed or contracted as a full-time employee of the PACE provider; 2.always be available in person or by telecommunication for all aspects of the PACE provider operation. The program director shall designate in writing a qualified individual to assume authority and control of the PACE provider if the program director is temporarily unavailable; 3.direct operations of the PACE provider; 4.be responsible for compliance with all regulations, laws, policies, and procedures applicable to the PACE provider; 5.act as a liaison between staff, contract personnel and the governing body; 6.ensure that all staff receive proper orientation and training on policies and procedures, and participant care and services as necessary to fulfill each staff person’s responsibilities; and 7.ensure that services are delivered according to the participant’s plan of care. D.Medical Director 1.The PACE provider shall employ or contract a medical director who is responsible for: a.the delivery of participant care; b.clinical outcomes; and c.the implementation, as well as oversight, of the quality improvement program. E.Professional Services Staff 1.The PACE provider shall employ, contract with, or ensure access to all necessary professional staff to meet the needs of each participant as identified in the participant’s plan of care. The professional staff may include, but not be limited to: a.licensed practical nurse(s); b.registered nurse(s); c.speech therapist(s); d.physical therapist(s); e.occupational therapist(s); f.master’s level social worker(s); g.registered dietitian(s); and h.recreational therapist(s) or activity coordinator(s). 2.The PACE center shall have an RN or LPN on the premises daily for at least eight hours or the number of hours the center is open, or during the time participants are present at the center, whichever is less. 3.The PACE center shall have a master’s level social worker employed and on-site for at least 10 hours per week to provide social services. 4.The PACE center shall have a recreational therapist or activity coordinator employed and on-site for at least 10 hours per week. They shall be responsible for carrying out the center’s individualized activity program for each participant. 5.Professional staff employed or contracted by the PACE provider shall hold a current, valid professional license in good standing issued by the appropriate licensing board. 6.The PACE provider shall maintain proof of annual verification of current professional licensure of all licensed professional staff. 7.All professional services furnished or provided shall be furnished or provided in accordance with professional standards of practice, according to the scope of practice requirements for each licensed discipline. F.The PACE provider shall employ, either directly or through contract, adequate DCS to ensure the provision of services as required by each participant’s plan of care. G.The PACE provider shall ensure all non-licensed DCS, either contracted or employed, meet the minimum mandatory qualifications and requirements for direct service workers as required by R.S. 40:2179-40:2179.1 or a subsequently amended statute and any rules published pursuant to those statutes. 1.All DCS shall have the ability to read and write at a level that allows them: a.to understand the participant’s plan of care; b.document services provided; and c.carry out directions competently as assigned. 2.All DCS shall be determined to be free of active tuberculosis disease before engaging in direct participant contact. H.The DCS shall be responsible for: 1.providing personal assistance to the participant, according to the plan of care; 2.providing the direct personal assistance to the participant at the time and place assigned; 3.reporting and communicating changes in a participant’s condition to a supervisor immediately upon discovery of the change; and 4.reporting and communicating a participant’s request for services or change in services to a supervisor. This shall occur within 24 hours of the next business day of such request. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: §4383.Incident and Accident Reports A.The PACE provider shall complete incident reports to HSS for each center participant involved in the following occurrences: 1.accidents and injuries; 2.any occurrence that has the potential for affecting the welfare of any other participant; 3.any elopement or attempted elopement; 4.when the whereabouts of a participant, expected to be at the center, is unknown; and 5.any suspected abuse, whether or not it occurred at the center. B.Progress notes documented on the day of the incident shall indicate that an incident report has been written. C.The completed individual incident report shall be in the participant’s file. A separate copy of all such documentation shall be kept in the provider’s administrative file. D.Incident reports shall include, at a minimum, the following information: 1.the name of the participant or participants; 2.the date and time of the incident; 3.a detailed description of the incident; 4.the name(s) of witnesses to the incident and his or her statements; and 5.a description of the action taken by the center regarding the incident. E.Incident reports shall be reviewed by the director, his or her designee or a medical professional. Incident reports shall be reviewed within 24 hours of the occurrence. A qualified professional shall recommend action, in a timely manner, as indicated by the consequences of the incident. F.IDT members shall review all incident reports quarterly and recommend action as indicated to: 1.ensure that the reports have all the required information; 2.identify staff training needs; 3.identify patterns that may indicate a need for changes in the center policies/practices; and 4.assist in identifying those participants: a.who may require changes in his or her plans of care; or b.who may not be appropriately placed in the PACE center. G.The PACE provider shall report abuse, neglect, extortion, or exploitation of participants. Reporting shall be pursuant to the provisions of R.S. 15:1504-1505, R.S. 40:2009.20, and any subsequently enacted laws. Providers shall ensure that staff comply with these regulations. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: §4385.Infection Control A.The PACE provider shall follow accepted infection control policies and standard procedures. The PACE provider shall include at a minimum the standard precautions developed by CDC. B.The PACE provider shall establish, implement, and maintain a documented infection control plan. The infection control plan utilizing acceptable standards of practice shall, at a minimum, meet the following requirements: 1.ensure a safe and sanitary environment; and 2.prevent and control the transmission of disease and infection. C.The infection control plan shall include, but not be limited to, the following in every PACE center and in each participant's place of residence: 1.procedures to: a.identify; b.investigate; c.control; d.prevent; and e.report infections; 2.procedures to record any incidents of infection; and 3.procedures to: a.analyze the incidents of infection to identify trends; and b.develop corrective actions related to the reduction of future incidents. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: Subchapter G.Enrollment and Disenrollment §4391.Enrollment A.The PACE provider shall have a written description of its enrollment policies and criteria that shall include at a minimum: 1.enrollment policies and procedures; 2.legal status of the participants served; 3.the age of the populations served; and 4.the services provided by the provider’s program(s). B.The enrollment information for individual participants shall include, but not be limited to: 1.the participant's name, date of birth, home address, and telephone number; 2.the name, address, and telephone number of the participant’s closest relative or friend; 3.a brief social history that includes the participant's: a.marital status; b.general health status; c.education; d.former occupation; e.leisure-time interest; and f.existence of supportive family members or friends; 4.the name, address, and telephone number of the participant's primary care provider; and 5.IDT assessments completed at the time of the participant's enrollment that include: a.special dietary needs; b.prescribed medication; c.allergies; d.any limitations on activity; e.the degree to which the participant is ambulant; f.visual or hearing limitations and/or other physical impairments; g.apparent mental state or degree of confusion or alertness; h.the ability to control bowel or bladder; i.the ability to feed self; j.the ability to dress self; and k.the ability to self-administer medication. C.The written description of enrollment policies and criteria shall be made available to: 1.the participant; and 2.his or her legal representative. D.The PACE provider shall not refuse to enroll any participant on the grounds of: 1.race; 2.sex; or 3.ethnic origin. E.The PACE provider shall not knowingly enroll any participant who engages in disruptive or threatening behavior such as: 1.a participant whose behavior jeopardizes: a.his or her health or safety; or b.the safety of others; or 2.a participant with decision-making capacity who consistently refuses to comply with: a.his or her individual plan of care; or b.the terms of the PACE enrollment agreement; or 3.a participant with a caregiver who engages in disruptive or threatening behavior that jeopardizes: a.the participant's health or safety; or b.the safety of the caregiver or others. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: §4393.Disenrollment A.The PACE provider shall have written policies and procedures governing voluntary and involuntary disenrollment. 1.The policy shall include the procedures for involuntary disenrollment due to a participant who engages in disruptive or threatening behavior. Disruptive or threatening behavior refers to a participant who exhibits either of the following: a.behavior that jeopardizes his or her health or safety, or the safety of others; or b.consistently refuses to comply with his or her individual plan of care or the terms of the PACE enrollment agreement. B.There shall be written documentation detailing the circumstances leading to any disenrollment. C.Prior to a planned disenrollment, the PACE provider’s IDT shall formulate an aftercare plan. The after-care plan shall specify needed supports and the resources available to the participant. D.Upon disenrollment, the PACE provider shall provide a summary of the participant's health record to the person or agency responsible for the future planning and care of the participant. The disenrollment summary shall include: 1.medical diagnoses; 2.medication regimen (current primary care provider’s orders); 3.treatment regimen (current primary care provider’s orders); 4.functional needs (inabilities); 5.any special equipment utilized (e.g. dentures, ambulatory aids, eyeglasses, etc.); 6.social needs; 7.financial resources; and 8.any other information that will enable the receiving entity or caregivers to provide the continued necessary care without interruption. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: §4395.Interdisciplinary Team A.The PACE provider shall establish IDT at each PACE center. The IDT shall: 1.comprehensively assess the needs of each participant; and 2.meet the individual needs of each participant. B.The PACE provider shall assign each participant to an IDT at the PACE center that the participant attends. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: §4397.Interdisciplinary Team Composition A.The IDT may be composed of either full-time staff members, contractual consultants, or a combination of both. The IDT shall be composed of members qualified to fill, at minimum, the roles identified in Subsection B of this Section, in accordance with CMS guidelines. One individual may fill two separate roles on the IDT where the individual meets applicable state licensure requirements. The individual shall be qualified to fill the two roles. The individual shall be able to provide appropriate care to meet the needs of participants. B.The IDT shall be composed of the following: 1.a primary care provider; 2.a registered nurse; 3.a master's-level social worker; 4.a physical therapist; 5.an occupational therapist; 6.a recreational therapist or activity coordinator; 7.a dietitian; 8.a PACE center manager; 9.a home care coordinator; 10.a personal care attendant or his or her representative; and 11.a driver or his or her representative. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: §4399.Interdisciplinary Team Responsibilities A.The IDT shall be responsible for the following for each participant: 1.the initial assessment, periodic reassessments, and plan of care; 2.the coordination and implementation of 24-hour care delivery. The care delivery shall meet participant needs across all care settings. The care delivery shall include, but not be limited to the following: a.ordering, approving, or authorizing all necessary care; b.communicating all necessary care and relevant instructions for care; c.ensuring care is implemented as it was ordered, approved, or authorized by the IDT; d.monitoring and evaluating the participant's condition to ensure that the care provided is effective and meets the participant's needs; and e.promptly modifying care when the IDT determines the participant's needs are not met to provide: i.safe care of the participant; ii.appropriate care to the participant; and iii.effective care to the participant; and 3.documenting all recommendations for care or services and the reason(s) for not approving or providing recommended care or services, if applicable. Documentation shall be in the participant’s medical record. B.The IDT shall review, assess, and act on recommendations from emergency or urgent care providers, employees, and contractors, including medical specialists. Specifically, the IDT shall ensure the following requirements are met. 1.The appropriate member(s) of the IDT shall review all recommendations from hospitals, emergency departments, and urgent care providers and determine if the recommended services are necessary to meet the participant's medical, physical, social, or emotional needs as quickly as the participant's health condition requires. Such reviews shall occur no later than 48 hours from the time of the participant's discharge. 2.The appropriate member(s) of the IDT shall review all recommendations from other employees and contractors and determine if the recommended services are necessary to meet the participant's medical, physical, social, or emotional needs as quickly as the participant's health condition requires. Such reviews shall occur no later than seven calendar days from the date the recommendation was made. 3.If recommendations are authorized or approved by the IDT or a member of the IDT, the services shall be promptly arranged and furnished as required by the conditions of the PACE agreement. C.The PACE provider shall establish, implement, and maintain documented internal procedures governing the exchange of information between team members, contractors, and participants and his or her caregivers. D.The participant, and/or family members or legal or personal representative if appropriate, shall be involved in the IDT staffing and any other meeting involving the care needed by the participant while receiving services provided by the PACE provider. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: §43101.Participant Assessment A.The IDT shall conduct an initial in-person comprehensive assessment of each participant. The assessment shall be completed in a timely manner. The assessment shall meet the requirements in Subsection E and F of this Section. B.As part of the initial comprehensive assessment, each of the following members of the IDT shall evaluate the participant in person and develop a discipline-specific assessment of the participant's health and social status: 1.a primary care provider; 2.a registered nurse; 3.a master’s-level social worker; 4.a physical therapist; 5.an occupational therapist; 6.a recreational therapist or activity coordinator; 7.a dietician; and 8.a home care coordinator. C.At the recommendation of the IDT, other professional disciplines) may be included in the initial comprehensive assessment process. Other professional disciplines may include: 1.speech-language pathology; 2.dentistry; or 3.audiology. D.The initial in-person comprehensive assessment shall at a minimum include the evaluation of: 1.physical and cognitive function and ability; 2.medication use; 3.participant and caregiver preferences for care; 4.socialization and availability of family support; 5.current health status and treatment needs; 6.nutritional status; 7.home environment, including home access and egress; 8.participant behavior; 9.psychosocial status; 10.medical and dental status; and 11.participant language. E.Within 30 calendar days of the date of enrollment, the IDT shall consolidate discipline-specific assessments into a single plan of care for each participant through: 1.team discussions; and 2.consensus of the entire IDT. F.When developing the plan of care, if the IDT determines that certain services are not necessary for the care of a participant, the reasoning behind the determination shall be documented in the plan of care. G.On at least a semi-annual basis, or more often if a participant's condition dictates, the following members of the IDT shall conduct an in-person reassessment: 1.primary care provider; 2.registered nurse; 3.master's-level social worker; and 4.other team members, that the primary care provider, RN, and master's-level social worker determine are actively involved in the development or implementation of the participant's plan of care. H.In addition to semi-annual reassessments, unscheduled reassessments may be required based on the following: 1.If the health or psychosocial status of a participant changes, the members of the IDT listed in Subsection B of this Section shall conduct an in-person reassessment. 2.In accordance with the PACE agreement requirements, the PACE provider: a.shall conduct an in-person reassessment if it expects to deny or partially deny a service determination request; and b.may conduct reassessments as determined necessary for approved services. I.When the IDT conducts semiannual or unscheduled reassessments, the IDT shall reevaluate and, if necessary, revise the plan of care. Revisions shall be in accordance with the PACE agreement requirements following the completion of all required assessments. J.IDT members shall document all assessment and reassessment information in the participant's medical record. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: §43103.Comprehensive Person-Centered Service Plan A.Basic Requirements 1.The IDT members shall develop, evaluate, and if necessary, revise a comprehensive person-centered service plan (CPSP) for each participant. 2.Each CPSP shall do the following: a.take into consideration the most current assessment findings; and b.identify services to be furnished to attain or maintain the participant's highest practicable level of well-being. B.Timeframes for Developing, Evaluating, and Revising the CPSP 1.The IDT shall complete the initial CPSP within 30 calendar days of the participant's date of enrollment. 2.At least once every 180 calendar days from the date the latest CPSP was finalized, the IDT shall: a.complete a re-evaluation of each participant’s CPSP; and b.complete revisions to each participant's CPSP, if necessary. 3.Except as specified in Paragraph C.4 of this Subsection, the IDT shall complete a re-evaluation of, and if necessary, revisions to a participant’s CPSP. This shall occur within 14 calendar days after the PACE provider determines, or should have determined, that there has been a change in the participant's health or psychosocial status. Such re-evaluation shall occur more quickly if the participant's condition requires. 4.If a participant is hospitalized within 14 calendar days of the change in participant status, the IDT shall complete a reevaluation of, and if necessary, revisions to the CPSP as quickly as the participant's condition requires. This shall occur no later than 14 calendar days after the date of discharge from the hospital. C.At a minimum, each CPSP shall meet the following requirements: 1.identify all the participants' current medical, physical, emotional, and social needs. Needs shall include those associated with: a.chronic diseases; b.behavioral disorders; and c.psychiatric disorders that require treatment or routine monitoring. 2.address the following factors: a.vision; b.hearing; c.dental; d.skin integrity; e.mobility; f.physical functioning, including activities of daily living; g.pain management; h.nutrition, including access to meals that meet the participant's daily nutritional and special dietary needs; i.the participant's ability to live safely in his or her home environment and community; j.home care; k.center attendance; l.transportation; and m.communication, including any identified language barriers; 3.identify each care and service intervention required to meet each medical, physical, emotional, and social need; 4.utilize the most appropriate interventions for each care need that advances the participant toward a measurable goal and outcome; 5.identify how each intervention shall be implemented, including a timeframe for implementation; 6.identify a measurable goal for each intervention; 7.identify how the goal for each intervention shall be evaluated to determine whether the intervention should be continued, discontinued, or modified; and 8.the participant's preferences and goals of care. D.Implementation of the CPSP. The team shall continuously do the following: 1.implement, coordinate, and monitor the CPSP regardless of whether the services are furnished by PACE employees or contractors, across all care settings; and 2.evaluate and monitor the participant's medical, physical, emotional, and social needs as well as the effectiveness of the plan of care, through: a.the provision of services; b.informal observation; c.input from participants or caregivers; and d.communications among members of the IDT and other employees or contractors. E.Participant and Caregiver Involvement in the CPSP 1.The IDT shall develop, evaluate, and revise each CPSP in collaboration with the participant, the participant's caregiver, or both. 2.The IDT shall review and discuss each plan of care with the participant or the participant's caregiver or both. This shall occur before the CPSP is completed to ensure that there is: a.agreement with the CPSP; and b.that the participant's concerns are addressed. F.Documentation. The team shall do the following: 1.Establish and implement a process to document and maintain records related to all requirements for CPSP in the participant's medical record. 2.Ensure that the most recent CPSP is available to all employees and contractors within the PACE provider as needed. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: §43105.Emergency Care A.A PACE provider shall ensure emergency care is provided when services are needed immediately in accordance with 42 CFR 460.100. Immediate need may be because of an injury or sudden illness and the time required to reach the PACE provider or one of its contract providers would cause risk of permanent damage to the participant's health. Emergency services include inpatient and outpatient services that meet the following requirements: 1.are furnished by a qualified emergency services provider, other than the PACE provider or one of its contract providers, either in or out of the PACE provider's geographic service location; or 2.are needed to evaluate or stabilize an emergency medical condition. B.Appropriate staff shall immediately notify the participant's primary care provider and the legal or personal representative of any: 1.emergency; 2.change in condition; or 3.injury to the participant that occurs at the center. C.A PACE provider shall have sufficient qualified and competent staff to respond to emergency medical situations. D.Appropriate staff shall monitor and report to the program director, any medical emergency or significant change in: 1.a participant’s health; or 2.a participant's functioning condition. E.A PACE provider shall have identification and emergency contact information on persons identified as having authority to make emergency medical decisions. This requirement is necessary in the case of the participant’s inability to do so independently. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: Subchapter H.Safety & Emergency Preparedness §43109.General Safety Practices A.The PACE center shall ensure that all poisonous, toxic, and flammable materials are safely stored in appropriate containers. The containers shall be labeled as to the contents. Such materials shall be: 1.maintained only as necessary; and 2.used in such a manner as to ensure the safety of participants, staff, and visitors. B.A PACE center shall meet the applicable provisions and shall proceed in accordance with the current life safety code standards. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: §43111.Emergency Preparedness A.A disaster or emergency may be a local, community-wide, regional, or statewide event. Disasters or emergencies may include, but are not limited to: 1.tornados; 2.fires; 3.floods; 4.hurricanes; 5.power outages; 6.chemical spills; 7.biohazards; 8.train wrecks; 9.declared health crisis; or 10.active shooter situations. B.In preparation for and response to emergencies and disasters, PACE providers shall: 1.ensure that each participant has a documented individual emergency preparedness plan (EPP); and 2.assist participants in identifying the specific resources available through family, friends, the neighborhood and the community. C.The PACE provider shall have written disaster and EPPs that are based on a risk assessment. The written disaster and EPP shall use an all-hazards approach for both internal and external occurrences developed and approved by the governing body and updated annually. 1.The written disaster and EPP shall be prepared in coordination with the PACE provider’s local and/or parish Office of Homeland Security and Emergency Preparedness (OHSEP). The written disaster and EPP shall include provisions for persons with disabilities. 2.The written disaster and EPP shall be updated annually: a.to maintain continuity of the PACE provider’s operations in preparation for, during, and after an emergency or disaster; and b.to manage the consequences of all disasters or emergencies that disrupt the PACE provider’s ability to: i.render care and treatment; or ii.threaten the lives or safety of the participants and staff. D.The PACE provider shall develop and implement policies and procedures based on the EPP, risk assessment, and communication plan. The policies and procedures shall be reviewed and updated at least annually. E.No later than the next business day, the PACE provider shall notify HSS if the PACE provider: 1.has an interruption in services; or 2.has a change in the licensed location due to an emergency. F.The PACE provider shall follow and execute its EPP during the occurrence of a declared disaster or other emergency. The EPP shall include, at a minimum: 1.provisions for the delivery of essential services to each participant as identified in the individualized emergency plan for each participant, whether the participant is in a shelter or other location; 2.provisions for the management of staff, including provisions for adequate, qualified staff as well as for distribution and assignment of responsibilities and functions; 3.provisions for back-up staff; 4.the method that the PACE provider shall utilize in notifying the participant’s family or caregiver if the participant is evacuated to another location. Evacuation may be made either by the provider or with the assistance or knowledge of the provider. This notification shall include: a.the date and approximate time that the PACE provider or participant is evacuating; b.the place or location to which the participant(s) is evacuating which includes the name, address and telephone numbers; and c.a telephone number that the family or responsible representative may call for information regarding the provider’s evacuation; 5.provisions for ensuring that sufficient supplies, medications, clothing and a copy of the individual service plan are sent with the participant, if the participant is evacuated; and 6.the procedure or methods that shall be used to ensure that identification accompanies the participant. The identification shall include the following information: a.current and active diagnoses; b.medication(s), including dosages and times administered; c.allergies; d.special dietary needs or restrictions; and e.next of kin, including contact information. G.The PACE provider shall review and update its EPP and each participant’s emergency plan at least annually. H.The PACE provider shall cooperate with the department and with the local or parish OHSEP if of an emergency or disaster. The PACE provider shall provide information as requested. I.The PACE provider shall monitor weather warnings, watches, and evacuation orders from local and state emergency preparedness officials. J.All agency employees, either contracted or staff, shall be trained in emergency or disaster preparedness. Training shall include: 1.orientation; 2.ongoing training; and 3.participation in planned drills for all personnel. K.Upon request by the department, the PACE provider shall submit a copy of its EPP and a written summary attesting how the EPP was followed and executed. The summary shall contain, at a minimum: 1.pertinent EPP provisions and how the EPP was followed and executed; 2.EPP provisions that were not followed; 3.reasons and mitigating circumstances for failure to follow and execute certain EPP provisions; 4.contingency arrangements made for those EPP provisions not followed; and 5.a list of all injuries and deaths of participants that occurred during execution of the EPP, evacuation, or temporary relocation. The date, time, causes, and circumstances of the injuries and deaths shall be included. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: Subchapter I.Physical Environment §43117.General Appearance and Conditions A.The standards in this Subchapter shall apply to: 1.any PACE center constructed after the effective date of this Rule; 2.alterations, additions, or substantial rehabilitation to an existing PACE center; or 3.adaptation of an existing building to create a PACE center. Cosmetic changes to the PACE center shall not be considered an alteration or substantial rehabilitation. Cosmetic changes include painting, flooring replacement, or minor repairs. B.A PACE center shall submit architectural plans and construction documents to the OSFM. The regulations and codes governing new PACE centers also apply if and when the PACE center proposes to begin operation in a building not previously and continuously used as a PACE center licensed under these regulations. C.The project shall be designed in accordance with the following criteria: 1.the requirements of the OSFM; 2.Part XIV (plumbing) of the Sanitary Code (LAC 51), state of Louisiana; and 3.the current department licensing regulations for PACE centers. E.The PACE center shall present an attractive outside and inside appearance. The PACE center shall be designed, constructed, equipped, and maintained to provide for the physical safety of participants, personnel, and visitors. The PACE center shall ensure a safe, sanitary, functional, and accessible, and comfortable environment for the delivery of services. 1.Illumination levels in all areas shall be adequate. Careful attention shall be given to avoid glare. 2.The design shall facilitate the participant’s: a.movement throughout the center; and b.involvement in activities and services. 3.Heating, cooling, and ventilation system(s) shall permit comfortable conditions. 4.Sufficient furniture shall be available for usage by the entire participant population in attendance. 5.Furniture and equipment used by participants shall be: a.selected for comfort and safety; and b.appropriate for use by persons with: i.visual and mobility limitations; and ii.other physical disabilities. 6.Floors and steps shall have a non-slippery surface. Floors and steps shall be dry when in use by the participants. Doorways and passageways shall be kept clear to allow free and unhindered passage. 7.A PACE provider shall establish, implement, and maintain a written plan. The written plan shall ensure that all equipment is maintained in accordance with manufacturer’s recommendations. 8.A PACE provider shall perform the manufacturer’s recommended maintenance on all equipment as indicated in the provider’s written plan. 9.A PACE center shall have an entry and exit drive to and from the main building entrance. The entry and exit drive shall allow: a.for picking up and dropping off participants; and b.for mail deliveries. 10.A PACE center licensed after the effective date of this Rule shall have a covered area at the building entrance. The covered area shall provide participants with protection from the weather. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: §43119.Waivers A.All new construction, additions, and renovations other than minor alterations, shall be in accordance with the specific requirements of the OSFM and the department, or its designee, who shall be responsible for the review and approval of architectural plans. Plans and specifications submitted to these offices shall be prepared by or under the direction of a licensed architect and/or a qualified licensed engineer and shall include scaled architectural plans stamped by an architect. 1.For all new construction, additions, and renovations, PACE providers shall follow the 2014 Edition of the Facility Guidelines Institute, Guidelines for Design and Construction of Hospitals and Outpatient Facilities, as adopted by the OSFM for building and construction. 2.The department’s secretary may, within his/her sole discretion, grant waivers to building and construction guidelines or requirements and to provisions of the licensing rules involving the clinical operation of the PACE center. The PACE provider shall submit a waiver request in writing to the department’s licensing section on forms prescribed by the department. a.In the waiver request, the PACE center shall demonstrate the following: i.how patient health, safety, and welfare will not be compromised if such waiver is granted; ii.how the quality of care offered will not be compromised if such waiver is granted; and iii.the ability of the PACE center to completely fulfill all other requirements of the service, condition, or regulation. b.The department’s licensing section shall have each waiver request reviewed by an internal waiver review committee (WRC). In conducting such internal waiver review, the following shall apply: i.the WRC may consult subject matter experts, including the OSFM; and ii.the WRC may require the PACE center to submit risk assessments or other documentation to the department. c.The director of the department’s licensing section shall submit the WRC’s recommendation on each waiver to the secretary or the secretary’s designee for final determination. d.The department shall issue a written decision about the waiver request to the PACE center. The granting of any waiver may be for a specific length of time. e.The written decision of the waiver request is final. There is no right to an appeal of the decision of the waiver request. f.If any waiver is granted, it is not transferable in an ownership change or change of location. g.Waivers are subject to review and revocation upon any change of circumstance related to the waiver or upon a finding that the health, safety, or welfare of a patient may be compromised. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: §43121.Space Requirements A.The PACE center shall have sufficient space and equipment to accommodate the full range of program activities and services. B.The PACE center shall include sufficient suitable space and equipment: 1.to provide primary medical care; 2.to conduct team meetings; and 3.to provide treatment, therapeutic recreation, restorative therapies, socialization, personal care, and dining. C.The PACE center shall be flexible and adaptable for: 1.large and small groups; and 2.individual activities and services. D.There shall be sufficient office space to permit staff to work effectively and without interruption. E.There shall be adequate storage space for PACE program and operating supplies. F.There shall be sufficient parking area available for: 1.safe daily delivery of participants; and 2.safe daily pick-up of participants. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: §43123.PACE Center Furnishings A.The PACE center shall be furnished and equipped to meet the needs of the participants. All furnishings and equipment shall be kept clean and in good repair. B.Adequate furniture shall be available and shall be appropriate for use by the participants in terms of comfort and safety. C.Dining area furnishings shall include tables and comfortable chairs. They shall be sufficient in number to serve all participants. Meals may be served either cafeteria style or directly at the table depending upon: 1.the method of food preparation; or 2.the physical condition of the participants. D.If the PACE center has a kitchen area, it shall: 1.meet all health and sanitation requirements; and 2.be of sufficient size to accommodate meal preparation for the proposed number of participants. E.There shall be sufficient toilet and hand-washing facilities to meet the needs of both males and females. The number of toilets and hand-washing facilities shall be not less than one for each 12 participants. 1.There shall be at least two toilet facilities when males and females are served. 2.Toilets and hand-washing facilities shall be equipped to be accessible for people with disabilities. F.There shall be a separate room or partitioned area for temporarily isolating a participant in case of illness. This room may be furnished with a bed or a recliner for the participant's use. AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and R.S. 40:2120.61 et seq. HISTORICAL NOTE:Promulgated by the Louisiana Department of Health, Health Standards Section, LR 52: Family Impact Statement In compliance with Act 1183 of the 1999 Regular Session of the Louisiana Legislature, the impact of this proposed Rule on the family has been considered. It is anticipated that this proposed Rule will have no impact on family functioning, stability, and autonomy as described in R.S. 49:972. Poverty Impact Statement In compliance with Act 854 of the 2012 Regular Session of the Louisiana Legislature, the poverty impact of this proposed Rule has been considered. It is anticipated that this proposed Rule will have no impact on child, individual, or family poverty in relation to individual or community asset development as described in R.S. 49:973. Small Business Analysis In compliance with the Small Business Protection Act, the economic impact of this proposed Rule on small businesses has been considered. It is anticipated that this proposed Rule will have no impact on the staffing requirements or qualifications required to provide the same level of service. It is anticipated that implementation of this proposed Rule will decrease the amount of licensure costs paid by those PACE providers who currently provide PACE services, as the number of required licenses will decrease from two to one. It is further anticipated that this proposed Rule may result in survey or investigation costs to a PACE provider that is subject to a survey or investigation. The total decreased or increased costs is indeterminable since there is no way to estimate the number of PACE providers that may be impacted by this Rule. Provider Impact Statement In compliance with House Concurrent Resolution (HCR) 170 of the 2014 Regular Session of the Louisiana Legislature, the provider impact of this proposed Rule has been considered. It is anticipated that this proposed Rule will have no impact on the staffing requirements or qualifications required to provide the same level of service. It is anticipated that implementation of this proposed Rule will decrease the amount of licensure costs paid by those PACE providers who currently provide PACE services, as the number of required licenses will decrease from two to one. It is further anticipated that this proposed Rule may result in survey or investigation costs to a PACE provider that is subject to a survey or investigation. The total decreased or increased costs is indeterminable since there is no way to estimate the number of PACE providers that may be impacted by this Rule. Public Comments Interested persons may submit written comments to Ms. Cecile Castello, Health Standards Section, Post Office Box 3767, Baton Rouge, LA 70821. Ms. Castello is responsible for responding to inquiries regarding this proposed Rule. The deadline for submitting written comments is 4:30 p.m. on October 23, 2026. Public Hearing Interested persons may submit a written request to conduct a public hearing by U.S. mail to the Office of the Secretary ATTN: LDH Rulemaking Coordinator, Post Office Box 629, Baton Rouge, LA 70821-0629; however, such request must be received no later than 4:30 p.m. on October 6, 2026. If the criteria set forth in R.S. 49:961(B)(1) are satisfied, LDH will conduct a public hearing at 9:30 a.m. on October 22, 2026, in Room 118 of the Bienville Building, which is located at 628 North Fourth Street, Baton Rouge, LA. To confirm whether a public hearing will be held, interested persons should first call Allen Enger at (225) 342-1342 after October 6, 2026. If a public hearing is to be held, all interested persons are invited to attend and present data, views, comments, or arguments, orally or in writing. Bruce D. Greenstein Secretary FISCAL AND ECONOMIC IMPACT STATEMENT FOR ADMINISTRATIVE RULES RULE TITLE: Program for All-Inclusive Care of the Elderly—Licensing Standards I.ESTIMATED IMPLEMENTATION COSTS (SAVINGS) TO STATE OR LOCAL GOVERNMENT UNITS (Summary) It is anticipated that implementation of this proposed rule will have no programmatic fiscal impact on the costs of the state or local governmental units other than the cost of promulgation in FY 27. It is anticipated that $8,308 SGR will be expended in FY 27 for the state's administrative expense for promulgation of this proposed rule and the final rule. This proposed rule adopts the minimum licensing standards for the program for all-inclusive care of the elderly (PACE). II.ESTIMATED EFFECT ON REVENUE COLLECTIONS OF STATE OR LOCAL GOVERNMENTAL UNITS (Summary) It is anticipated that the amount of revenue collected in licensure fees paid by those providers who currently provide PACE services may decrease, as the number of required licenses will decrease from two to one. It is further anticipated that the amount of revenue collected may increase because of survey or investigation fees assessed to a PACE provider should that provider be subject to a survey or investigation. The total of decreased or increased fees is indeterminable since there is no way to estimate the number of PACE providers that may be impacted by this rule. III.ESTIMATED COSTS AND/OR ECONOMIC BENEFITS TO DIRECTLY AFFECTED PERSONS, SMALL BUSINESSES, OR NONGOVERNMENTAL GROUPS (Summary) It is anticipated that implementation of this proposed Rule will decrease the amount of licensure costs paid by those PACE providers who currently provide PACE services, as the number of required licenses will decrease from two to one. It is further anticipated that this proposed Rule may result in survey or investigation costs to a PACE provider that is subject to a survey or investigation. The total decreased or increased costs is indeterminable since there is no way to estimate the number of PACE providers that may be impacted by this rule. IV.ESTIMATED EFFECT ON COMPETITION AND EMPLOYMENT (Summary) It is anticipated that this proposed rule will not have an impact on competition and employment. Cecile Castello, RNAlan M. Boxberger Interim Deputy Assistant SecretaryLegislative Fiscal Officer 2609#058Legislative Fiscal Office