Title 42—Public Health--Volume 1
PART 441—SERVICES: REQUIREMENTS AND LIMITS APPLICABLE TO SPECIFIC SERVICES
§ 441.450   Basis, scope, and definitions.
(a) Basis. This subpart implements section 1915(j) of the Act concerning the self-directed personal assistance services (PAS) option through a State Plan.
(b) Scope. A self-directed PAS option is designed to allow individuals, or their representatives, if applicable, to exercise decision-making authority in identifying, accessing, managing and purchasing their PAS. This authority includes, at a minimum, all of the following:
(1) The purchase of PAS and supports for PAS.
(2) Recruiting workers.
(3) Hiring and discharging workers.
(4) Training workers and accessing training provided by or through the State if additional worker training is required or desired by the participant, or participant's representative, if applicable.
(5) Specifying worker qualifications.
(6) Determining worker duties.
(7) Scheduling workers.
(8) Supervising workers.
(9) Evaluating worker performance.
(10) Determining the amount paid for a service, support or item.
(11) Scheduling when services are provided.
(12) Identifying service workers.
(13) Reviewing and approving invoices.
(c) Definitions. As used in this part—
Assessment of need means an evaluation of the needs, strengths, and preferences of participants for services. This includes one or more processes to obtain information about an individual, including health condition, personal goals and preferences, functional limitation, age, school, employment, household, and other factors that are relevant to the authorization and provision of services. Assessment information supports the development of the service plan and the subsequent service budget.
Individualized backup plan means a written plan that meets all of the following:
(1) Is sufficiently individualized to address each participant's critical contingencies or incidents that would pose a risk of harm to the participant's health or welfare;
(2) Must demonstrate an interface with the risk management provision at § 441.476 which requires States to assess and identify the potential risks to the participant (such as any critical health needs), and ensure that the risks and how they will be managed are the result of discussion and negotiation among the persons involved in the service plan development;
(3) Must not include the 911 emergency system or other emergency system as the sole backup feature of the plan; and
(4) Must be incorporated into the participant's service plan.
Legally liable relatives means persons who have a duty under the provisions of State law to care for another person. Legally liable relatives may include any of the following:
(1) The parent (biological or adoptive) of a minor child or the guardian of a minor child who must provide care to the child.
(2) Legally-assigned caretaker relatives.
(3) A spouse.
Self-directed personal assistance services (PAS) means personal care and related services, or home and community-based services otherwise available under the State plan or a 1915(c) waiver program that are provided to an individual who has been determined eligible for the PAS option. Self-directed PAS also includes, at the State's option, items that increase the individual's independence or substitutes (such as a microwave oven or an accessibility ramp) for human assistance, to the extent the expenditures would otherwise be made for the human assistance.
Self-direction means the opportunity for participants or their representatives to exercise choice and control over the budget, planning, and purchase of self-directed PAS, including the amount, duration, scope, provider, and location of service provision.
Service budget means an amount of funds that is under the control and direction of a participant, or the participant's representative, if any, when the State has selected the State plan option for provision of self-directed PAS. It is developed using a person-centered and directed process and is individually tailored in accordance with the participant's needs and personal preferences as established in the service plan.
Service plan means the written document that specifies the services and supports (regardless of funding source) that are to be furnished to meet the needs of a participant in the self-directed PAS option and to assist the participant to direct the PAS and to live in the community. The service plan is developed based on the assessment of need using a person-centered and directed process. The service plan supports the participant's engagement in community life and respects the participant's preferences, choices, and abilities. The participant's representative, if any, families, friends, and professionals, as desired or required by the participant, will be involved in the service-planning process. Service plans must meet the requirements of § 441.301(c)(3), except that the references to section 1915(c) of the Act are instead references to section 1915(j) of the Act.
Support system means information, counseling, training, and assistance that support the participant (or the participant's family or representative, as appropriate) in identifying, accessing, managing, and directing their PAS and supports and in purchasing their PAS identified in the service plan and budget.
Supports broker or consultant means an individual who supports participants in directing their PAS and service budgets. The supports broker or consultant is an agent of the participants and takes direction from the participants, or their representatives, if applicable, about what information, counseling, training or assistance is needed or desired. The supports broker or consultant is primarily responsible for facilitating participants' development of a service budget and effective management of the participants' PAS and budgets in a manner that comports with the participants' preferences. States must develop a protocol to ensure that supports brokers or consultants: are accessible to participants; have regularly scheduled phone and in-person contacts with participants; monitor whether participants' health status has changed and whether expenditure of funds are being made in accordance with service budgets. States must also develop the training requirements and qualifications for supports brokers or consultants that include, at a minimum, the following:
(1) An understanding of the philosophy of self-direction and person-centered and directed planning;
(2) The ability to facilitate participants' independence and participants' preferences in managing PAS and budgets, including any risks assumed by participants;
(3) The ability to develop service budgets and ensure appropriate documentation; and
(4) Knowledge of the PAS and resources available in the participant's community and how to access them.
The availability of a supports broker or consultant to each participant is a requirement of the support system.
§ 441.452   Self-direction: General.
(a) States must have in place, before electing the self-directed PAS option, personal care services through the State plan, or home and community-based services under a section 1915(c) waiver.
(b) The State must have both traditional service delivery and the self-directed PAS service delivery option available in the event that an individual voluntarily disenrolls or is involuntarily disenrolled, from the self-directed PAS service delivery option.
(c) The State's assessment of an individual's needs must form the basis of the level of services for which the individual is eligible.
(d) Nothing in this subpart will be construed as affecting an individual's Medicaid eligibility, including that of an individual whose Medicaid eligibility is attained through receipt of section 1915(c) waiver services.
§ 441.454   Use of cash.
(a) States have the option of disbursing cash prospectively to participants, or their representatives, as applicable, self-directing their PAS.
(b) States that choose to offer the cash option must ensure compliance with all applicable requirements of the Internal Revenue Service, including, but not limited to, retaining required forms and payment of FICA, FUTA and State unemployment taxes.
(c) States must permit participants, or their representatives, as applicable, using the cash option to choose to use the financial management entity for some or all of the functions described in § 441.484(c).
(d) States must make available a financial management entity to a participant, or the participant's representative, if applicable, who has demonstrated, after additional counseling, information, training, or assistance, that the participant cannot effectively manage the cash option described in paragraph (a) of this section.
§ 441.456   Voluntary disenrollment.
(a) States must permit a participant to voluntarily disenroll from the self-directed PAS option at any time and return to a traditional service delivery system.
(b) The State must specify in a section 1915(j) State plan amendment the safeguards that are in place to ensure continuity of services during the transition from self-directed PAS.
§ 441.458   Involuntary disenrollment.
(a) States must specify the conditions under which a participant may be involuntarily disenrolled from the self-directed PAS option.
(b) CMS must approve the State's conditions under which a participant may be involuntarily disenrolled.
(c) The State must specify in the section 1915(j) State plan amendment the safeguards that are in place to ensure continuity of services during the transition from self-directed PAS.
§ 441.460   Participant living arrangements.
(a) Self-directed PAS are not available to an individual who resides in a home or property that is owned, operated, or controlled by a PAS provider who is not related to the individual by blood or marriage.
(b) States may specify additional restrictions on a participant's living arrangements if they have been approved by CMS.
§ 441.462   Statewideness, comparability and limitations on number served.
A State may do the following:
(a) Provide self-directed PAS without regard to the requirements of statewideness.
(b) Limit the population eligible to receive these services without regard to comparability of amount, duration, and scope of services.
(c) Limit the number of persons served without regard to comparability of amount, duration, and scope of services.
§ 441.464   State assurances.
A State must assure that the following requirements are met:
(a) Necessary safeguards. Necessary safeguards have been taken to protect the health and welfare of individuals furnished services under the program and to assure the financial accountability for funds expended for self-directed services.
(1) Safeguards must prevent the premature depletion of the participant directed budget as well as identify potential service delivery problems that might be associated with budget underutilization.
(2) These safeguards may include the following:
(i) Requiring a case manager, support broker or other person to monitor the participant's expenditures.
(ii) Requiring the financial management entity to flag significant budget variances (over and under expenditures) and bring them to the attention of the participant, the participant's representative, if applicable, case manager, or support broker.
(iii) Allocating the budget on a monthly or quarterly basis.
(iv) Other appropriate safeguards as determined by the State.
(3) Safeguards must be designed so that budget problems are identified on a timely basis so that corrective action may be taken, if necessary.
(b) Evaluation of need. The State must perform an evaluation of the need for personal care under the State Plan or services under a section 1915(c) waiver program for individuals who meet the following requirements:
(1) Are entitled to medical assistance for personal care services under the State plan or receiving home and community based services under a section 1915(c) waiver program.
(2) May require self-directed PAS.
(3) May be eligible for self-directed PAS.
(c) Notification of feasible alternatives. Individuals who are likely to require personal care under the State plan, or home and community-based services under a section 1915(c) waiver program are informed of the feasible alternatives, if available, under the State's self-directed PAS State plan option, at the choice of these individuals, to the provision of personal care services under the State plan, or PAS under a section 1915(c) home and community-based services waiver program. Information on feasible alternatives must be communicated to the individual in a manner and language understandable by the individual. Such information includes, but is not limited to, the following:
(1) Information about self-direction opportunities that is sufficient to inform decision-making about the election of self-direction and provided on a timely basis to an individual or the representative which minimally includes the following:
(i) Elements of self-direction compared to non-self-directed PAS.
(ii) Individual responsibilities and potential liabilities under the self-direction service delivery model.
(iii) The choice to receive PAS through a waiver program administered under section 1915(c) of the Act, regardless of delivery system, if applicable.
(iv) The option, if available, to receive and manage the cash amount of their individual budget allocation.
(2) When and how this information is provided.
(d) Support system. States must provide, or arrange for the provision of, a support system that meets the following conditions:
(1) Appropriately assesses and counsels an individual, or the individual's representative, if applicable, before enrollment, including information about disenrollment.
(2) Provides appropriate information, counseling, training, and assistance to ensure that a participant is able to manage the services and budgets. Such information must be communicated to the participant in a manner and language understandable by the participant. The support activities must include at least the following:
(i) Person-centered planning and how it is applied.
(ii) Information about the services available for self-direction.
(iii) Range and scope of individual choices and options.
(iv) Process for changing the service plan and service budget.
(v) Grievance process.
(vi) Risks and responsibilities of self-direction.
(vii) The ability to freely choose from available PAS providers.
(viii) Individual rights.
(ix) Reassessment and review schedules.
(x) Defining goals, needs, and preferences.
(xi) Identifying and accessing services, supports, and resources.
(xii) Development of risk management agreements.
(xiii) Development of an individualized backup plan.
(xiv) Recognizing and reporting critical events.
(xv) Information about an advocate or advocacy systems available in the State and how a participant, or a participant's representative, if applicable, can access the advocate or advocacy systems.
(3) Offers additional information, counseling, training, or assistance, including financial management services under either of the following conditions:
(i) At the request of the participant, or participant's representative, if applicable, for any reason.
(ii) When the State has determined the participant, or participant's representative, if applicable, is not effectively managing the services identified in the service plan or budget.
(4) The State may mandate the use of additional assistance, including the use of a financial management entity, or may initiate an involuntary disenrollment in accordance with § 441.458, if, after additional information, counseling, training or assistance is provided to a participant (or participant's representative, if applicable), the participant (or participant's representative, if applicable) has continued to demonstrate an inability to effectively manage the services and budget.
(5) Implement and maintain a grievance process in accordance with § 441.301(c)(7), except that the references to section 1915(c) of the Act are instead references to section 1915(j) of the Act.
(e) Incident management system. The State operates and maintains an incident management system that identifies, reports, triages, investigates, resolves, tracks, and trends critical incidents and adheres to requirements of § 441.302(a)(6), except that the references to section 1915(c) of the Act are instead references to section 1915(j) of the Act.
(f) Payment rates. Payment rates are adequate to ensure a sufficient direct care workforce to meet the needs of beneficiaries and provide access to services in the amount, duration, and scope specified in beneficiaries' person-centered service plans, in accordance with § 441.302(k), except that the references to section 1915(c) of the Act are instead references to section 1915(j) of the Act.
(g) Annual report. The State must provide to CMS an annual report on the number of individuals served and the total expenditures on their behalf in the aggregate.
(h) Three-year evaluation. The State must provide to CMS an evaluation of the overall impact of the self-directed PAS option on the health and welfare of participating individuals compared to non-participants every 3 years.
§ 441.466   Assessment of need.
States must conduct an assessment of the participant's needs, strengths, and preferences in accordance with the following:
(a) States may use one or more processes and techniques to obtain information about an individual, including health condition, personal goals and preferences for the provision of services, functional limitations, age, school, employment, household, and other factors that are relevant to the need for and authorization and provision of services.
(b) Assessment information supports the determination that an individual requires PAS and also supports the development of the service plan and budget.
§ 441.468   Service plan elements.
(a) The service plan must include at least the following:
(1) The scope, amount, frequency, and duration of each service.
(2) The type of provider to furnish each service.
(3) Location of the service provision.
(4) The identification of risks that may pose harm to the participant along with a written individualized backup plan for mitigating those risks.
(b) A State must develop a service plan for each program participant using a person-centered and directed planning process to ensure the following:
(1) The identification of each program participant's preferences, choices, and abilities, and strategies to address those preferences, choices, and abilities.
(2) The option for the program participant, or participant's representative, if applicable, to exercise choice and control over services and supports discussed in the plan.
(3) Assessment of, and planning for avoiding, risks that may pose harm to a participant.
(c) All of the State's applicable policies and procedures associated with service plan development must be carried out and include, but are not limited to, the following:
(1) Allow the participant, or participant's representative, if applicable, the opportunity to engage in, and direct, the process to the extent desired.
(2) Allow the participant, or participant's representative, if applicable, the opportunity to involve family, friends, and professionals (as desired or required) in the development and implementation of the service plan.
(3) Ensure the planning process is timely.
(4) Ensure the participant's needs are assessed and that the services meet the participant's needs.
(5) Ensure the responsibilities for service plan development are identified.
(6) Ensure the qualifications of the individuals who are responsible for service plan development reflect the nature of the program's target population(s).
(7) Ensure the State reviews the service plan annually, or whenever necessary due to a change in the participant's needs or health status.
(8) Ensure that a participant may request revisions to a service plan, based on a change in needs or health status.
(d) When an entity that is permitted to provide other State plan services is responsible for service plan development, the State must describe the safeguards that are in place to ensure that the service provider's role in the planning process is fully disclosed to the participant, or participant's representative, if applicable, and controls are in place to avoid any possible conflict of interest.
(e) An approved self-directed service plan conveys authority to the participant, or participant's representative, if applicable, to perform, at a minimum, the following tasks:
(1) Recruit and hire workers to provide self-directed services, including specifying worker qualifications.
(2) Fire workers.
(3) Supervise workers in the provision of self-directed services.
(4) Manage workers in the provision of self-directed services, which includes the following functions:
(i) Determining worker duties.
(ii) Scheduling workers.
(iii) Training workers in assigned tasks.
(iv) Evaluating workers performance.
(5) Determine the amount paid for a service, support, or item.
(6) Review and approve provider invoices.
§ 441.470   Service budget elements.
A service budget must be developed and approved by the State based on the assessment of need and service plan and must include the following:
(a) The specific dollar amount a participant may utilize for services and supports.
(b) How the participant is informed of the amount of the service budget before the service plan is finalized.
(c) The procedures for how the participant, or participant's representative, if applicable, may adjust the budget, including the following:
(1) How the participant, or participant's representative, if applicable, may freely make changes to the budget.
(2) The circumstances, if any, that may require prior approval before a budget adjustment is made.
(3) The circumstances, if any, that may require a change in the service plan.
(d) The procedure(s) that governs how a person, at the election of the State, may reserve funds to purchase items that increase independence or substitute for human assistance, to the extent that expenditures would otherwise be made for the human assistance, including additional goods, supports, services or supplies.
(e) The procedure(s) that governs how a person may use a discretionary amount, if applicable, to purchase items not otherwise delineated in the budget or reserved for permissible purchases.
(f) How participants, or their representative, if applicable, are afforded the opportunity to request a fair hearing under § 441.300 if a participant's, or participant's representative, if applicable, request for a budget adjustment is denied or the amount of the budget is reduced.
§ 441.472   Budget methodology.
(a) The State shall set forth a budget methodology that ensures service authorization resides with the State and meets the following criteria:
(1) The State's method of determining the budget allocation is objective and evidence based utilizing valid, reliable cost data.
(2) The State's method is applied consistently to participants.
(3) The State's method is open for public inspection.
(4) The State's method includes a calculation of the expected cost of the self-directed PAS and supports, if those services and supports were not self-directed.
(5) The State has a process in place that describes the following:
(i) Any limits it places on self-directed services and supports, and the basis for the limits.
(ii) Any adjustments that will be allowed and the basis for the adjustments.
(b) The State must have procedures to safeguard participants when the budgeted service amount is insufficient to meet a participant's needs.
(c) The State must have a method of notifying participants, or their representative, if applicable, of the amount of any limit that applies to a participant's self-directed PAS and supports.
(d) The budget may not restrict access to other medically necessary care and services furnished under the plan and approved by the State but not included in the budget.
(e) The State must have a procedure to adjust a budget when a reassessment indicates a change in a participant's medical condition, functional status or living situation.
§ 441.474   Quality assurance and improvement plan.
(a) The State must provide a quality assurance and improvement plan that describes the State's system of how it will perform activities of discovery, remediation and quality improvement in order to learn of critical incidents or events that affect participants, correct shortcomings, and pursue opportunities for system improvement.
(b) The quality assurance and improvement plan shall also describe the system performance measures, outcome measures, and satisfaction measures that the State must use to monitor and evaluate the self-directed State plan option. Quality of care measures must be made available to CMS upon request and include indicators approved or prescribed by the Secretary.
(c) The quality assurance and improvement plan must comply with all components of §§ 441.302(k)(6), 441.311 and 441.312 and related reporting requirements relevant to the State's self-directed PAS program, except that the references to section 1915(c) of the Act are instead references to section 1915(j) of the Act.
§ 441.476   Risk management.
(a) The State must specify the risk assessment methods it uses to identify potential risks to the participant.
(b) The State must specify any tools or instruments it uses to mitigate identified risks.
(c) The State must ensure that each service plan includes the risks that an individual is willing and able to assume, and the plan for how identified risks will be mitigated.
(d) The State must ensure that the risk management plan is the result of discussion and negotiation among the persons designated by the State to develop the service plan, the participant, the participant's representative, if any, and others from whom the participant may seek guidance.
§ 441.478   Qualifications of providers of personal assistance.
(a) States have the option to permit participants, or their representatives, if applicable, to hire any individual capable of providing the assigned tasks, including legally liable relatives, as paid providers of the PAS identified in the service plan and budget.
(b) Participants, or their representatives, if applicable, retain the right to train their workers in the specific areas of personal assistance needed by the participant and to perform the needed assistance in a manner that comports with the participant's personal, cultural, and/or religious preferences. Participants, or their representatives, if applicable, also have the right to access other training provided by or through the State so that their PAS providers can meet any additional qualifications required or desired by participants, or participants' representatives, if applicable.
(c) Participants, or their representatives, if applicable, retain the right to establish additional staff qualifications based on participants' needs and preferences.
§ 441.480   Use of a representative.
(a) States may permit participants to appoint a representative to direct the provision of self-directed PAS on their behalf. The following types of representatives are permissible:
(1) A minor child's parent or guardian.
(2) An individual recognized under State law to act on behalf of an incapacitated adult.
(3) A State-mandated representative, after approval by CMS of the State criteria, if the participant has demonstrated, after additional counseling, information, training or assistance, the inability to self-direct PAS.
(b) A person acting as a representative for a participant receiving self-directed PAS is prohibited from acting as a provider of self-directed PAS to the participant.
§ 441.482   Permissible purchases.
(a) Participants, or their representatives, if applicable, may, at the State's option, use their service budgets to pay for items that increase a participant's independence or substitute (such as a microwave oven or an accessibility ramp) for human assistance, to the extent that expenditures would otherwise be made for the human assistance.
(b) The services, supports and items that are purchased with a service budget must be linked to an assessed participant need or goal established in the service plan.
§ 441.484   Financial management services.
(a) States may choose to provide financial management services to participants, or their representatives, as applicable, self-directing PAS, with the exception of those participants utilizing the cash option who directly perform those functions, utilizing a financial management entity, through the following arrangements:
(1) States may use a reporting or subagent through its fiscal intermediary in accordance with section 3504 of the IRS Code and Revenue Procedure 80-4 and Notice 2003-70; or
(2) States may use a vendor organization that has the capabilities to perform the required tasks in accordance with Section 3504 of the IRS Code and Revenue Procedure 70-6. When private entities furnish financial management services, the procurement method must meet the requirements set forth in 45 CFR 75.326 through 75.340.
(b) States must provide oversight of financial management services by performing the following functions:
(1) Monitoring and assessing the performance of financial management entity, including assuring the integrity of financial transactions they perform.
(2) Designating a State entity or entities responsible for this monitoring.
(3) Determining how frequently financial management entity performance will be assessed.
(c) A financial management entity must provide functions including, but not limited to, the following:
(1) Collect and process timesheets of the participant's workers.
(2) Process payroll, withholding, filing and payment of applicable Federal, State and local employment-related taxes and insurance.
(3) Maintain a separate account for each participant's budget.
(4) Track and report disbursements and balances of participant funds.
(5) Process and pay invoices for goods and services approved in the service plan.
(6) Provide to participants periodic reports of expenditures and the status of the approved service budget.
(d) States not utilizing a financial management entity must perform the functions listed in paragraph (c) of this section on behalf of participants self-directing PAS, with the exception of those participants utilizing the cash option who directly perform those functions.
(e) States will be reimbursed for the cost of financial management services, either provided directly or through a financial management entity, at the administrative rate of 50 percent.
§ 441.486   Website transparency.
For States subject to the requirements of subpart J, the State must operate a website consistent with § 441.313, except that the references to section 1915(c) of the Act are instead references to section 1915(j) of the Act.
§ 441.500   Basis and scope.
(a) Basis. This subpart implements section 1915(k) of the Act, referred to as the Community First Choice option (hereafter Community First Choice), to provide home and community-based attendant services and supports through a State plan.
(b) Scope. Community First Choice is designed to make available home and community-based attendant services and supports to eligible individuals, as needed, to assist in accomplishing activities of daily living (ADLs), instrumental activities of daily living (IADLs), and health-related tasks through hands-on assistance, supervision, or cueing.
§ 441.505   Definitions.
As used in this subpart:
Activities of daily living (ADLs) means basic personal everyday activities including, but not limited to, tasks such as eating, toileting, grooming, dressing, bathing, and transferring.
Agency-provider model means a method of providing Community First Choice services and supports under which entities contract for or provide through their own employees, the provision of such services and supports, or act as the employer of record for attendant care providers selected by the individual enrolled in Community First Choice.
Backup systems and supports means electronic devices used to ensure continuity of services and supports. These items may include an array of available technology, personal emergency response systems, and other mobile communication devices. Persons identified by an individual can also be included as backup supports.
Health-related tasks means specific tasks related to the needs of an individual, which can be delegated or assigned by licensed health-care professionals under State law to be performed by an attendant.
Individual means the eligible individual and, if applicable, the individual's representative.
Individual's representative means a parent, family member, guardian, advocate, or other person authorized by the individual to serve as a representative in connection with the provision of CFC services and supports. This authorization should be in writing, when feasible, or by another method that clearly indicates the individual's free choice. An individual's representative may not also be a paid caregiver of an individual receiving services and supports under this subpart.
Instrumental activities of daily living (IADLs) means activities related to living independently in the community, including but not limited to, meal planning and preparation, managing finances, shopping for food, clothing, and other essential items, performing essential household chores, communicating by phone or other media, and traveling around and participating in the community.
Other models means methods, other than an agency-provider model or the self-directed model with service budget, for the provision of self-directed services and supports, as approved by CMS.
Self-directed means a consumer controlled method of selecting and providing services and supports that allows the individual maximum control of the home and community-based attendant services and supports, with the individual acting as the employer of record with necessary supports to perform that function, or the individual having a significant and meaningful role in the management of a provider of service when the agency-provider model is utilized. Individuals exercise as much control as desired to select, train, supervise, schedule, determine duties, and dismiss the attendant care provider.
Self-directed model with service budget means methods of providing self-directed services and supports using an individualized service budget. These methods may include the provision of vouchers, direct cash payments, and/or use of a fiscal agent to assist in obtaining services.
§ 441.510   Eligibility.
To receive Community First Choice services and supports under this section, an individual must meet the following requirements:
(a) Be eligible for medical assistance under the State plan;
(b) As determined annually—
(1) Be in an eligibility group under the State plan that includes nursing facility services; or
(2) If in an eligibility group under the State plan that does not include such nursing facility services, have an income that is at or below 150 percent of the Federal poverty level (FPL). In determining whether the 150 percent of the FPL requirement is met, States must apply the same methodologies as would apply under their Medicaid State plan, including the same income disregards in accordance with section 1902(r)(2) of the Act; and,
(c) Receive a determination, at least annually, that in the absence of the home and community-based attendant services and supports provided under this subpart, the individual would otherwise require the level of care furnished in a hospital, a nursing facility, an intermediate care facility for individuals with intellectual disabilities, an institution providing psychiatric services for individuals under age 21, or an institution for mental diseases for individuals age 65 or over, if the cost could be reimbursed under the State plan. The State administering agency may permanently waive the annual recertification requirement for an individual if:
(1) It is determined that there is no reasonable expectation of improvement or significant change in the individual's condition because of the severity of a chronic condition or the degree of impairment of functional capacity; and
(2) The State administering agency, or designee, retains documentation of the reason for waiving the annual recertification requirement.
(d) For purposes of meeting the criterion under paragraph (b) of this section, individuals who qualify for medical assistance under the special home and community-based waiver eligibility group defined at section 1902(a)(10)(A)(ii)(VI) of the Act must meet all section 1915(c) requirements and receive at least one home and community-based waiver service per month.
(e) Individuals receiving services through Community First Choice will not be precluded from receiving other home and community-based long-term care services and supports through other Medicaid State plan, waiver, grant or demonstration authorities.
§ 441.515   Statewideness.
States must provide Community First Choice to individuals:
(a) On a statewide basis.
(b) In a manner that provides such services and supports in the most integrated setting appropriate to the individual's needs, and without regard to the individual's age, type or nature of disability, severity of disability, or the form of home and community-based attendant services and supports that the individual requires to lead an independent life.
§ 441.520   Included services.
(a) If a State elects to provide Community First Choice, the State must provide all of the following services:
(1) Assistance with ADLs, IADLs, and health-related tasks through hands-on assistance, supervision, and/or cueing.
(2) Acquisition, maintenance, and enhancement of skills necessary for the individual to accomplish ADLs, IADLs, and health-related tasks.
(3) Backup systems or mechanisms to ensure continuity of services and supports, as defined in § 441.505 of this subpart.
(4) Voluntary training on how to select, manage and dismiss attendants.
(b) At the State's option, the State may provide permissible services and supports that are linked to an assessed need or goal in the individual's person-centered service plan. Permissible services and supports may include, but are not limited to, the following:
(1) Expenditures for transition costs such as rent and utility deposits, first month's rent and utilities, bedding, basic kitchen supplies, and other necessities linked to an assessed need for an individual to transition from a nursing facility, institution for mental diseases, or intermediate care facility for Individuals with Intellectual Disabilities to a home and community-based setting where the individual resides;
(2) Expenditures relating to a need identified in an individual's person-centered service plan that increases an individual's independence or substitutes for human assistance, to the extent that expenditures would otherwise be made for the human assistance.
§ 441.525   Excluded services.
Community First Choice may not include the following:
(a) Room and board costs for the individual, except for allowable transition services described in § 441.520(b)(1) of this subpart.
(b) Special education and related services provided under the Individuals with Disabilities Education Act that are related to education only, and vocational rehabilitation services provided under the Rehabilitation Act of 1973.
(c) Assistive devices and assistive technology services, other than those defined in § 441.520(a)(3) of this subpart, or those that meet the requirements at § 441.520(b)(2) of this subpart.
(d) Medical supplies and medical equipment, other than those that meet the requirements at § 441.520(b)(2) of this subpart.
(e) Home modifications, other than those that meet the requirements at § 441.520(b) of this subpart.
§ 441.530   Home and Community-Based Setting.
(a) States must make available attendant services and supports in a home and community-based setting consistent with both paragraphs (a)(1) and (a)(2) of this section.
(1) Home and community-based settings must have all of the following qualities, and such other qualities as the Secretary determines to be appropriate, based on the needs of the individual as indicated in their person-centered service plan:
(i) The setting is integrated in and supports full access of individuals receiving Medicaid HCBS to the greater community, including opportunities to seek employment and work in competitive integrated settings, engage in community life, control personal resources, and receive services in the community, to the same degree of access as individuals not receiving Medicaid HCBS.
(ii) The setting is selected by the individual from among setting options, including non-disability specific settings and an option for a private unit in a residential setting. The setting options are identified and documented in the person-centered service plan and are based on the individual's needs, preferences, and, for residential settings, resources available for room and board.
(iii) Ensures an individual's rights of privacy, dignity and respect, and freedom from coercion and restraint.
(iv) Optimizes but does not regiment individual initiative, autonomy, and independence in making life choices, including but not limited to, daily activities, physical environment, and with whom to interact.
(v) Facilitates individual choice regarding services and supports, and who provides them.
(vi) In a provider-owned or controlled residential setting, in addition to the above qualities at paragraphs (a)(1)(i) through (v) of this section, the following additional conditions must be met:
(A) The unit or dwelling is a specific physical place that can be owned, rented or occupied under a legally enforceable agreement by the individual receiving services, and the individual has, at a minimum, the same responsibilities and protections from eviction that tenants have under the landlord tenant law of the State, county, city or other designated entity. For settings in which landlord tenant laws do not apply, the State must ensure that a lease, residency agreement or other form of written agreement will be in place for each participant and that the document provides protections that address eviction processes and appeals comparable to those provided under the jurisdiction's landlord tenant law.
(B) Each individual has privacy in their sleeping or living unit:
( 1 ) Units have entrance doors lockable by the individual, with only appropriate staff having keys to doors as needed.
( 2 ) Individuals sharing units have a choice of roommates in that setting.
( 3 ) Individuals have the freedom to furnish and decorate their sleeping or living units within the lease or other agreement.
(C) Individuals have the freedom and support to control their own schedules and activities, and have access to food at any time.
(D) Individuals are able to have visitors of their choosing at any time.
(E) The setting is physically accessible to the individual.
(F) Any modification of the additional conditions, under paragraphs (a)(1)(vi)(A) through (D) of this section, must be supported by a specific assessed need and justified in the person-centered service plan. The following requirements must be documented in the person-centered service plan:
( 1 ) Identify a specific and individualized assessed need.
( 2 ) Document the positive interventions and supports used prior to any modifications to the person-centered service plan.
( 3 ) Document less intrusive methods of meeting the need that have been tried but did not work.
( 4 ) Include a clear description of the condition that is directly proportionate to the specific assessed need.
( 5 ) Include regulation collection and review of data to measure the ongoing effectiveness of the modification.
( 6 ) Include established time limits for periodic reviews to determine if the modification is still necessary or can be terminated.
( 7 ) Include the informed consent of the individual.
( 8 ) Include an assurance that interventions and supports will cause no harm to the individual.
(2) Home and community-based settings do not include the following:
(i) A nursing facility;
(ii) An institution for mental diseases;
(iii) An intermediate care facility for individuals with intellectual disabilities;
(iv) A hospital providing long-term care services; or
(v) Any other locations that have qualities of an institutional setting, as determined by the Secretary. Any setting that is located in a building that is also a publicly or privately operated facility that provides inpatient institutional treatment, or in a building on the grounds of, or immediately adjacent to, a public institution, or any other setting that has the effect of isolating individuals receiving Medicaid HCBS from the broader community of individuals not receiving Medicaid HCBS will be presumed to be a setting that has the qualities of an institution unless the Secretary determines through heightened scrutiny, based on information presented by the State or other parties, that the setting does not have the qualities of an institution and that the setting does have the qualities of home and community-based settings.
(b) [Reserved]
§ 441.535   Assessment of functional need.
States must conduct a face-to-face assessment of the individual's needs, strengths, preferences, and goals for the services and supports provided under Community First Choice in accordance with the following:
(a) States may use one or more processes and techniques to obtain information, including telemedicine, or other information technology medium, in lieu of a face-to-face assessment if the following conditions apply:
(1) The health care professional(s) performing the assessment meet the provider qualifications defined by the State, including any additional qualifications or training requirements for the operation of required information technology;
(2) The individual receives appropriate support during the assessment, including the use of any necessary on-site support-staff; and
(3) The individual is provided the opportunity for an in-person assessment in lieu of one performed via telemedicine.
(b) Assessment information supports the determination that an individual requires Community First Choice and also supports the development of the person-centered service plan and, if applicable, service budget.
(c) The assessment of functional need must be conducted at least every 12 months, as needed when the individual's support needs or circumstances change significantly necessitating revisions to the person-centered service plan, and at the request of the individual.
(d) Other requirements as determined by the Secretary.
§ 441.540   Person-centered service plan.
(a) Person-centered planning process. The person-centered planning process is driven by the individual. The process—
(1) Includes people chosen by the individual.
(2) Provides necessary information and support to ensure that the individual directs the process to the maximum extent possible, and is enabled to make informed choices and decisions.
(3) Is timely and occurs at times and locations of convenience to the individual.
(4) Reflects cultural considerations of the individual.
(5) Includes strategies for solving conflict or disagreement within the process, including clear conflict-of-interest guidelines for all planning participants.
(6) Offers choices to the individual regarding the services and supports they receive and from whom.
(7) Includes a method for the individual to request updates to the plan.
(8) Records the alternative home and community-based settings that were considered by the individual.
(b) The person-centered service plan. The person-centered service plan must reflect the services and supports that are important for the individual to meet the needs identified through an assessment of functional need, as well as what is important to the individual with regard to preferences for the delivery of such services and supports. Commensurate with the level of need of the individual, and the scope of services and supports available under Community First Choice, the plan must:
(1) Reflect that the setting in which the individual resides is chosen by the individual.
(2) Reflect the individual's strengths and preferences.
(3) Reflect clinical and support needs as identified through an assessment of functional need.
(4) Include individually identified goals and desired outcomes.
(5) Reflect the services and supports (paid and unpaid) that will assist the individual to achieve identified goals, and the providers of those services and supports, including natural supports. Natural supports cannot supplant needed paid services unless the natural supports are unpaid supports that are provided voluntarily to the individual in lieu of an attendant.
(6) Reflect risk factors and measures in place to minimize them, including individualized backup plans.
(7) Be understandable to the individual receiving services and supports, and the individuals important in supporting him or her.
(8) Identify the individual and/or entity responsible for monitoring the plan.
(9) Be finalized and agreed to in writing by the individual and signed by all individuals and providers responsible for its implementation.
(10) Be distributed to the individual and other people involved in the plan.
(11) Incorporate the service plan requirements for the self-directed model with service budget at § 441.550, when applicable.
(12) Prevent the provision of unnecessary or inappropriate care.
(13) Other requirements as determined by the Secretary.
(c) Reviewing the person-centered service plan. The State must ensure that the person-centered service plan for every individual is reviewed, and revised as appropriate, based upon the reassessment of functional need at least every 12 months, when the individual's circumstances or needs change significantly, and at the request of the individual. States must adhere to the requirements of § 441.301(c)(3), except that the references to section 1915(c) of the Act are instead references to section 1915(k) of the Act.
§ 441.545   Service models.
A State may choose one or more of the following as the service delivery model to provide self-directed home and community-based attendant services and supports:
(a) Agency-provider model. (1) The agency-provider model is a delivery method in which the services and supports are provided by entities, under a contract or provider agreement with the State Medicaid agency or delegated entity to provide services. Under this model, the entity either provides the services directly through their employees or arranges for the provision of services under the direction of the individual receiving services.
(2) Under the agency-provider model for Community First Choice, individuals maintain the ability to have a significant role in the selection and dismissal of the providers of their choice, for the delivery of their specific care, and for the services and supports identified in their person-centered service plan.
(b) Self-directed model with service budget. A self-directed model with a service budget is one in which the individual has both a person-centered service plan and a service budget based on the assessment of functional need.
(1) Financial management entity. States must make available financial management activities to all individuals with a service budget. The financial management entity performs functions including, but not limited to, the following activities:
(i) Collect and process timesheets of the individual's attendant care providers.
(ii) Process payroll, withholding, filing, and payment of applicable Federal, State, and local employment related taxes and insurance.
(iii) Separately track budget funds and expenditures for each individual.
(iv) Track and report disbursements and balances of each individual's funds.
(v) Process and pay invoices for services in the person-centered service plan.
(vi) Provide individual periodic reports of expenditures and the status of the approved service budget to the individual and to the State.
(vii) States may perform the functions of a financial management entity internally or use a vendor organization that has the capabilities to perform the required tasks in accordance with all applicable requirements of the Internal Revenue Service.
(2) Direct cash. States may disburse cash prospectively to individuals self-directing their Community First Choice services and supports, and must meet the following requirements:
(i) Ensure compliance with all applicable requirements of the Internal Revenue Service, and State employment and taxation authorities, including but not limited to, retaining required forms and payment of FICA, FUTA and State unemployment taxes.
(ii) Permit individuals using the cash option to choose to use the financial management entity for some or all of the functions described in paragraph (b)(1)(ii) of this section.
(iii) Make available a financial management entity to an individual who has demonstrated, after additional counseling, information, training, or assistance that the individual cannot effectively manage the cash option described in this section.
(iv) The State may require an individual to use a financial management entity, but must provide the individual with the conditions under which this option would be enforced.
(3) Vouchers. States have the option to issue vouchers to individuals who self-direct their Community First Choice services and supports as long as the requirements in paragraphs (b)(2)(i) through (iv) of this paragraph are met.
(c) Other service delivery models. States have the option of proposing other service delivery models. Such models are defined by the State and approved by CMS.
§ 441.550   Service plan requirements for self-directed model with service budget.
The person-centered service plan under the self-directed model with service budget conveys authority to the individual to perform, at a minimum, the following tasks:
(a) Recruit and hire or select attendant care providers to provide self-directed Community First Choice services and supports, including specifying attendant care provider qualifications.
(b) Dismiss specific attendant care providers of Community First Choice services and supports.
(c) Supervise attendant care providers in the provision of Community First Choice services and supports.
(d) Manage attendant care providers in the provision of Community First Choice services and supports, which includes the following functions:
(1) Determining attendant care provider duties.
(2) Scheduling attendant care providers.
(3) Training attendant care providers in assigned tasks.
(4) Evaluating attendant care providers' performance.
(e) Determining the amount paid for a service, support, or item, in accordance with State and Federal compensation requirements.
(f) Reviewing and approving provider payment requests.
§ 441.555   Support system.
For each service delivery model available, States must provide, or arrange for the provision of, a support system that meets all of the following conditions:
(a) Appropriately assesses and counsels an individual before enrollment.
(b) Provides appropriate information, counseling, training, and assistance to ensure that an individual is able to manage the services and budgets if applicable.
(1) This information must be communicated to the individual in a manner and language understandable by the individual. To ensure that the information is communicated in an accessible manner, information should be communicated in plain language and needed auxiliary aids and services should be provided.
(2) The support activities must include at least the following:
(i) Person-centered planning and how it is applied.
(ii) Range and scope of individual choices and options.
(iii) Process for changing the person-centered service plan and, if applicable, service budget.
(iv) Grievance process.
(v) Information on the risks and responsibilities of self-direction.
(vi) The ability to freely choose from available home and community-based attendant providers, available service delivery models and if applicable, financial management entities.
(vii) Individual rights, including appeal rights.
(viii) Reassessment and review schedules.
(ix) Defining goals, needs, and preferences of Community First Choice services and supports.
(x) Identifying and accessing services, supports, and resources.
(xi) Development of risk management agreements.
(A) The State must specify in the State Plan amendment any tools or instruments used to mitigate identified risks.
(B) States utilizing criminal or background checks as part of their risk management agreement will bear the costs of such activities.
(xii) Development of a personalized backup plan.
(xiii) Recognizing and reporting critical events.
(xiv) Information about an advocate or advocacy systems available in the State and how an individual can access the advocate or advocacy systems.
(c) Establishes conflict of interest standards for the assessments of functional need and the person-centered service plan development process that apply to all individuals and entities, public or private. At a minimum, these standards must ensure that the individuals or entities conducting the assessment of functional need and person-centered service plan development process are not:
(1) Related by blood or marriage to the individual, or to any paid caregiver of the individual.
(2) Financially responsible for the individual.
(3) Empowered to make financial or health-related decisions on behalf of the individual.
(4) Individuals who would benefit financially from the provision of assessed needs and services.
(5) Providers of State plan HCBS for the individual, or those who have an interest in or are employed by a provider of State plan HCBS for the individual, except when the State demonstrates that the only willing and qualified entity/entities to perform assessments of functional need and develop person-centered service plans in a geographic area also provides HCBS, and the State devises conflict of interest protections including separation of assessment/planning and HCBS provider functions within provider entities, which are described in the State plan, and individuals are provided with a clear and accessible alternative dispute resolution process.
(d) Ensures the responsibilities for assessment of functional need and person-centered service plan development are identified.
(e) Implement and maintain a grievance process, in accordance with § 441.301(c)(7), except that the references to section 1915(c) of the Act are instead references to section 1915(k) of the Act.
§ 441.560   Service budget requirements.
(a) For the self-directed model with a service budget, a service budget must be developed and approved by the State based on the assessment of functional need and person-centered service plan and must include all of the following requirements:
(1) The specific dollar amount an individual may use for Community First Choice services and supports.
(2) The procedures for informing an individual of the amount of the service budget before the person-centered service plan is finalized.
(3) The procedures for how an individual may adjust the budget including the following:
(i) The procedures for an individual to freely adjust amounts allocated to specific services and supports within the approved service budget.
(ii) The circumstances, if any, that may require prior approval by the State before a budget adjustment is made.
(4) The circumstances, if any, that may require a change in the person-centered service plan.
(5) The procedures that govern the determination of transition costs and other permissible services and supports as defined at § 441.520(b).
(6) The procedures for an individual to request a fair hearing under Subpart E of this title if an individual's request for a budget adjustment is denied or the amount of the budget is reduced.
(b) The budget methodology set forth by the State to determine an individual's service budget amount must:
(1) Be objective and evidence-based utilizing valid, reliable cost data.
(2) Be applied consistently to individuals.
(3) Be included in the State plan.
(4) Include a calculation of the expected cost of Community First Choice services and supports, if those services and supports are not self-directed.
(5) Have a process in place that describes the following:
(i) Any limits the State places on Community First Choice services and supports, and the basis for the limits.
(ii) Any adjustments that are allowed and the basis for the adjustments.
(c) The State must have procedures in place that will provide safeguards to individuals when the budgeted service amount is insufficient to meet the individual's needs.
(d) The State must have a method of notifying individuals of the amount of any limit that applies to an individual's Community First Choice services and supports. Notice must be communicated in an accessible format, communicated in plain language, and needed auxiliary aids and services should be provided.
(e) The budget may not restrict access to other medically necessary care and services furnished under the State plan and approved by the State but which are not included in the budget.
(f) The State must have a procedure to adjust a budget when a reassessment indicates a change in an individual's medical condition, functional status, or living situation.
§ 441.565   Provider qualifications.
(a) For all service delivery models:
(1) An individual retains the right to train attendant care providers in the specific areas of attendant care needed by the individual, and to have the attendant care provider perform the needed assistance in a manner that comports with the individual's personal, cultural, and/or religious preferences.
(2) An individual retains the right to establish additional staff qualifications based on the individual's needs and preferences.
(3) Individuals also have the right to access other training provided by or through the State so that their attendant care provider(s) can meet any additional qualifications required or desired by individuals.
(b) For the agency-provider model, the State must define in writing adequate qualifications for providers in the agency model of Community First Choice services and supports.
(c) For the self-directed model with service budget, an individual has the option to permit family members, or any other individuals, to provide Community First Choice services and supports identified in the person-centered service plan, provided they meet the qualifications to provide the services and supports established by the individual, including additional training.
(d) For other models, the applicability of requirements at paragraphs (b) or (c) of this section will be determined based on the description and approval of the model.
§ 441.570   State assurances.
A State must assure the following requirements are met:
(a) Necessary safeguards have been taken to protect the health and welfare of enrollees in Community First Choice, including adherence to section 1903(i) of the Act that Medicaid payment shall not be made for items or services furnished by individuals or entities excluded from participating in the Medicaid Program.
(b) For the first full 12 month period in which the State plan amendment is implemented, the State must maintain or exceed the level of State expenditures for home and community-based attendant services and supports provided under sections 1115, 1905(a), 1915, or otherwise under the Act, to individuals with disabilities or elderly individuals attributable to the preceding 12 month period.
(c) All applicable provisions of the Fair Labor Standards Act of 1938.
(d) All applicable provisions of Federal and State laws regarding the following:
(1) Withholding and payment of Federal and State income and payroll taxes.
(2) The provision of unemployment and workers compensation insurance.
(3) Maintenance of general liability insurance.
(4) Occupational health and safety.
(5) Any other employment or tax related requirements.
(e) An incident management system in accordance with § 441.302(a)(6) is implemented, except that the references to section 1915(c) of the Act are instead references to section 1915(k) of the Act.
(f) Payment rates are adequate to ensure a sufficient direct care workforce to meet the needs of beneficiaries and provide access to services in the amount, duration, and scope specified in beneficiaries' person-centered service plans, in accordance with § 441.302(k), except that the references to section 1915(c) of the Act are instead references to section 1915(k) of the Act.
§ 441.575   Development and Implementation Council.
(a) States must establish a Development and Implementation Council, the majority of which is comprised of individuals with disabilities, elderly individuals, and their representatives.
(b) States must consult and collaborate with the Council when developing and implementing a State plan amendment to provide Community First Choice services and supports.
§ 441.580   Data collection.
A State must provide the following information regarding the provision of home and community-based attendant services and supports under Community First Choice for each Federal fiscal year for which the services and supports are provided:
(a) The number of individuals who are estimated to receive Community First Choice services and supports under this State plan option during the Federal fiscal year.
(b) The number of individuals who received the services and supports during the preceding Federal fiscal year.
(c) The number of individuals served broken down by type of disability, age, gender, education level, and employment status.
(d) The specific number of individuals who have been previously served under sections 1115, 1915(c) and (i) of the Act, or the personal care State plan option.
(e) Data regarding how the State provides Community First Choice and other home and community-based services.
(f) The cost of providing Community First Choice and other home and community-based services and supports.
(g) Data regarding how the State provides individuals with disabilities who otherwise qualify for institutional care under the State plan or under a waiver the choice to receive home and community-based services in lieu of institutional care.
(h) Data regarding the impact of Community First Choice services and supports on the physical and emotional health of individuals.
(i) Data and information as required in §§ 441.302(k)(6) and 441.311, except that the references to section 1915(c) of the Act are instead references to section 1915(k) of the Act.
(j) Other data as determined by the Secretary.
§ 441.585   Quality assurance system.
(a) States must establish and maintain a comprehensive, continuous quality assurance system, described in the State plan amendment, which includes the following:
(1) A quality improvement strategy.
(2) Methods to continuously monitor the health and welfare of each individual who receives home and community-based attendant services and supports, including a process for the mandatory reporting, investigation, and resolution of allegations of neglect, abuse, or exploitation in connection with the provision of such services and supports.
(3) Measures individual outcomes associated with the receipt of home and community-based attendant services and supports as set forth in the person centered service plan, particularly for the health and welfare of individuals receiving such services and supports. These measures must be reported to CMS upon request.
(4) Standards for all service delivery models for training, appeals for denials and reconsideration procedures for an individual's person-centered service plan.
(5) Other requirements as determined by the Secretary.
(b) The State must ensure the quality assurance system will employ methods that maximizes individual independence and control, and provides information about the provisions of quality improvement and assurance to each individual receiving such services and supports.
(c) The State must elicit and incorporate feedback from individuals and their representatives, disability organizations, providers, families of disabled or elderly individuals, members of the community and others to improve the quality of the community-based attendant services and supports benefit.
(d) The State must implement the Home and Community-Based Services Quality Measure Set in accordance with § 441.312, except that the references to section 1915(c) of the Act are instead references to section 1915(k) of the Act.
§ 441.590   Increased Federal financial participation.
Beginning October 1, 2011, the FMAP applicable to the State will be increased by 6 percentage points, for the provision of Community First Choice services and supports, under an approved State plan amendment.
§ 441.595   Website transparency.
For States subject to the requirements of subpart K, the State must operate a website consistent with § 441.313, except that the references to section 1915(c) of the Act are instead references to section 1915(k) of the Act.
§ 441.600   Basis and purpose.
This subpart implements sections 1902(a)(62) and 1928 of the Act by requiring states to provide for a program for the purchase and distribution of pediatric vaccines to program-registered providers for the immunization of vaccine-eligible children.
§ 441.605   General requirements.
(a) Federally-purchased vaccines under the VFC Program are made available to children who are 18 years of age or younger and who are any of the following:
(1) Eligible for Medicaid.
(2) Not insured.
(3) Not insured with respect to the vaccine and who are administered pediatric vaccines by a federally qualified health center (FQHC) or rural health clinic.
(4) An Indian, as defined in section 4 of the Indian Health Care Improvement Act.
(b) Under the VFC program, vaccines must be administered by program-registered providers. Section 1928(c) of the Act defines a program-registered provider as any health care provider that meets the following requirements:
(1) Is licensed or authorized to administer pediatric vaccines under the law of the state in which the administration occurs without regard to whether or not the provider is a Medicaid-participating provider.
(2) Submits to the state an executed provider agreement in the form and manner specified by the Secretary.
(3) Has not been found, by the Secretary or the state to have violated the provider agreement or other applicable requirements established by the Secretary or the state.
§ 441.610   State plan requirements.
A state plan must provide that the Medicaid agency meets the requirements of this part.
§ 441.615   Administration fee requirements.
(a) Under the VFC Program, a provider who administers a qualified pediatric vaccine to a federally vaccine-eligible child, may not impose a charge for the cost of the vaccine.
(1) A provider can impose a fee for the administration of a qualified pediatric vaccine as long as the fee does not exceed the costs of the administration (as determined by the Secretary based on actual regional costs for the administration).
(2) A provider may not deny administration of a qualified pediatric vaccine to a vaccine-eligible child due to the inability of the child's parents or legal guardian to pay the administration fee.
(b) The Secretary must publish each State's regional maximum charge for the VFC program, which represents the maximum amount that a provider in a state could charge for the administration of qualified pediatric vaccines to federally vaccine-eligible children under the VFC program.
(c) An interim formula has been established for the calculation of a state's regional maximum administration fee. That formula is as follows: National charge data × updated geographic adjustment factors (GAFs) = maximum VFC fee.
(d) The State Medicaid Agency must submit a state plan amendment that identifies the amount that the state will pay providers for the administration of a qualified pediatric vaccine to a Medicaid-eligible child under the VFC program. The amount identified by the state cannot exceed the state's regional maximum administration fee.
(e) Physicians participating in the VFC program can charge federally vaccine-eligible children who are not enrolled in Medicaid the maximum administration fee (if that fee reflects the provider's cost of administration) regardless of whether the state has established a lower administration fee under the Medicaid program. However, there would be no federal Medicaid matching funds available for the administration since these children are not eligible for Medicaid.
§ 441.700   Basis and purpose.
Section 1915(i) of the Act permits States to offer one or more home and community-based services (HCBS) under their State Medicaid plans to qualified individuals with disabilities or individuals who are elderly. Those services are listed in § 440.182 of this chapter, and are described by the State, including any limitations of the services. This optional benefit is known as the State plan HCBS benefit. This subpart describes what a State Medicaid plan must provide when the State elects to include the optional benefit, and defines State responsibilities.
§ 441.705   State plan requirements.
A State plan that provides section 1915(i) of the Act State plan home and community-based services must meet the requirements of this subpart.
§ 441.710   State plan home and community-based services under section 1915(i)(1) of the Act.
(a) Home and Community-Based Setting. States must make State plan HCBS available in a home and community-based setting consistent with both paragraphs (a)(1) and (a)(2) of this section.
(1) Home and community-based settings must have all of the following qualities, and such other qualities as the Secretary determines to be appropriate, based on the needs of the individual as indicated in their person-centered service plan:
(i) The setting is integrated in and supports full access of individuals receiving Medicaid HCBS to the greater community, including opportunities to seek employment and work in competitive integrated settings, engage in community life, control personal resources, and receive services in the community, to the same degree of access as individuals not receiving Medicaid HCBS.
(ii) The setting is selected by the individual from among setting options, including non-disability specific settings and an option for a private unit in a residential setting. The setting options are identified and documented in the person-centered service plan and are based on the individual's needs, preferences, and, for residential settings, resources available for room and board.
(iii) Ensures an individual's rights of privacy, dignity and respect, and freedom from coercion and restraint.
(iv) Optimizes, but does not regiment, individual initiative, autonomy, and independence in making life choices, including but not limited to, daily activities, physical environment, and with whom to interact.
(v) Facilitates individual choice regarding services and supports, and who provides them.
(vi) In a provider-owned or controlled residential setting, in addition to the above qualities at paragraphs (a)(1)(i) through (v) of this section, the following additional conditions must be met:
(A) The unit or dwelling is a specific physical place that can be owned, rented, or occupied under a legally enforceable agreement by the individual receiving services, and the individual has, at a minimum, the same responsibilities and protections from eviction that tenants have under the landlord/tenant law of the state, county, city, or other designated entity. For settings in which landlord tenant laws do not apply, the State must ensure that a lease, residency agreement or other form of written agreement will be in place for each HCBS participant and that the document provides protections that address eviction processes and appeals comparable to those provided under the jurisdiction's landlord tenant law;
(B) Each individual has privacy in their sleeping or living unit:
( 1 ) Units have entrance doors lockable by the individual, with only appropriate staff having keys to doors;
( 2 ) Individuals sharing units have a choice of roommates in that setting; and
( 3 ) Individuals have the freedom to furnish and decorate their sleeping or living units within the lease or other agreement.
(C) Individuals have the freedom and support to control their own schedules and activities, and have access to food at any time;
(D) Individuals are able to have visitors of their choosing at any time;
(E) The setting is physically accessible to the individual; and
(F) Any modification of the additional conditions, under paragraphs (a)(1)(vi)(A) through (D) of this section, must be supported by a specific assessed need and justified in the person-centered service plan. The following requirements must be documented in the person-centered service plan:
( 1 ) Identify a specific and individualized assessed need.
( 2 ) Document the positive interventions and supports used prior to any modifications to the person-centered service plan.
( 3 ) Document less intrusive methods of meeting the need that have been tried but did not work.
( 4 ) Include a clear description of the condition that is directly proportionate to the specific assessed need.
( 5 ) Include regular collection and review of data to measure the ongoing effectiveness of the modification.
( 6 ) Include established time limits for periodic reviews to determine if the modification is still necessary or can be terminated.
( 7 ) Include the informed consent of the individual.
( 8 ) Include an assurance that interventions and supports will cause no harm to the individual.
(2) Home and community-based settings do not include the following:
(i) A nursing facility.
(ii) An institution for mental diseases.
(iii) An intermediate care facility for individuals with intellectual disabilities.
(iv) A hospital.
(v) Any other locations that have qualities of an institutional setting, as determined by the Secretary. Any setting that is located in a building that is also a publicly or privately operated facility that provides inpatient institutional treatment, or in a building on the grounds of, or immediately adjacent to, a public institution, or any other setting that has the effect of isolating individuals receiving Medicaid HCBS from the broader community of individuals not receiving Medicaid HCBS will be presumed to be a setting that has the qualities of an institution unless the Secretary determines through heightened scrutiny, based on information presented by the State or other parties, that the setting does not have the qualities of an institution and that the setting does have the qualities of home and community-based settings.
(3) Compliance and transition:
(i) States submitting state plan amendments for new section 1915(i) of the Act benefits must provide assurances of compliance with the requirements of this section for home and community-based settings as of the effective date of the state plan amendment;
(ii) CMS will require transition plans for existing section 1915(c) waivers and approved state plans providing home and community-based services under section 1915(i) to achieve compliance with this section, as follows:
(A) For each approved section 1915(i) of the Act benefit subject to renewal or submitted for amendment within one year after the effective date of this regulation, the State must submit a transition plan at the time of the renewal or amendment request that sets forth the actions the State will take to bring the specific 1915(i) State plan benefit into compliance with this section. The approval will be contingent on the inclusion of the transition plan approved by CMS. The transition plan must include all elements required by the Secretary; and within one hundred and twenty days of the submission of the first renewal or amendment request the State must submit a transition plan detailing how the State will operate all section 1915(c) HCBS waivers and any section 1915(i) State plan benefit in accordance with this section. The transition plan must include all elements including timelines and deliverables as approved by the Secretary.
(B) For States that do not have a section 1915(c) waiver or a section 1915(i) State plan benefit due for renewal or proposed for amendments within one year of the effective date of this regulation, the State must submit a transition plan detailing how the State will operate all section 1915(c) waivers and any section 1915(i) State plan benefit in accordance with this section. This plan must be submitted no later than one year after the effective date of this regulation. The transition plan must include all elements including timelines and deliverables as approved by the Secretary.
(iii) A State must provide at least a 30-day public notice and comment period regarding the transition plan(s) that the State intends to submit to CMS for review and consideration, as follows:
(A) The State must at a minimum provide two (2) statements of public notice and public input procedures.
(B) The State must ensure the full transition plan(s) is available to the public for public comment.
(C) The State must consider and modify the transition plan, as the State deems appropriate, to account for public comment.
(iv) A State must submit to CMS, with the proposed transition plan:
(A) Evidence of the public notice required.
(B) A summary of the comments received during the public notice period, reasons why comments were not adopted, and any modifications to the transition plan based upon those comments.
(v) Upon approval by CMS, the State will begin implementation of the transition plans. The State's failure to submit an approvable transition plan as required by this section and/or to comply with the terms of the approved transition plan may result in compliance actions, including but not limited to deferral/disallowance of Federal Financial Participation.
(b) Needs-Based Eligibility Requirement. Meet needs-based criteria for eligibility for the State plan HCBS benefit, as required in § 441.715(a).
(c) Minimum State plan HCBS Requirement. Be assessed to require at least one section 1915(i) home and community-based service at a frequency determined by the State, as required in § 441.720(a)(5).
(d) Target Population. Meet any applicable targeting criteria defined by the State under the authority of paragraph (e)(2) of this section.
(e) Nonapplication. The State may elect in the State plan amendment approved under this subpart not to apply the following requirements when determining eligibility:
(1) Section 1902(a)(10)(C)(i)(III) of the Act, pertaining to income and resource eligibility rules for the medically needy living in the community, but only for the purposes of providing State plan HCBS.
(2) Section 1902(a)(10)(B) of the Act, pertaining to comparability of Medicaid services, but only for the purposes of providing section 1915(i) State plan HCBS. In the event that a State elects not to apply comparability requirements:
(i) The State must describe the group(s) receiving State plan HCBS, subject to the Secretary's approval. Targeting criteria cannot have the impact of limiting the pool of qualified providers from which an individual would receive services, or have the impact of requiring an individual to receive services from the same entity from which they purchase their housing. These groups must be defined on the basis of any combination of the following:
(A) Age.
(B) Diagnosis.
(C) Disability.
(D) Medicaid Eligibility Group.
(ii) The State may elect in the State plan amendment to limit the availability of specific services defined under the authority of § 440.182(c) of this chapter or to vary the amount, duration, or scope of those services, to one or more of the group(s) described in this paragraph.
§ 441.715   Needs-based criteria and evaluation.
(a) Needs-based criteria. The State must establish needs-based criteria for determining an individual's eligibility under the State plan for the HCBS benefit, and may establish needs-based criteria for each specific service. Needs-based criteria are factors used to determine an individual's requirements for support, and may include risk factors. The criteria are not characteristics that describe the individual or the individual's condition. A diagnosis is not a sufficient factor on which to base a determination of need. A criterion can be considered needs-based if it is a factor that can only be ascertained for a given person through an individualized evaluation of need.
(b) More stringent institutional and waiver needs-based criteria. The State plan HCBS benefit is available only if the State has in effect needs-based criteria (as defined in paragraph (a) of this section), for receipt of services in nursing facilities as defined in section 1919(a) of the Act, intermediate care facilities for individuals with intellectual disabilities as defined in § 440.150 of this chapter, and hospitals as defined in § 440.10 of this chapter for which the State has established long-term level of care (LOC) criteria, or waivers offering HCBS, and these needs-based criteria are more stringent than the needs-based criteria for the State plan HCBS benefit. If the State defines needs-based criteria for individual State plan home and community-based services, it may not have the effect of limiting who can benefit from the State plan HCBS in an unreasonable way, as determined by the Secretary.
(1) These more stringent criteria must meet the following requirements:
(i) Be included in the LOC determination process for each institutional service and waiver.
(ii) Be submitted for inspection by CMS with the State plan amendment that establishes the State Plan HCBS benefit.
(iii) Be in effect on or before the effective date of the State plan HCBS benefit.
(2) In the event that the State modifies institutional LOC criteria to meet the requirements under paragraph (b) or (c)(6) of this section that such criteria be more stringent than the State plan HCBS needs-based eligibility criteria, States may continue to receive FFP for individuals receiving institutional services or waiver HCBS under the LOC criteria previously in effect.
(c) Adjustment authority. The State may modify the needs-based criteria established under paragraph (a) of this section, without prior approval from the Secretary, if the number of individuals enrolled in the State plan HCBS benefit exceeds the projected number submitted annually to CMS. The Secretary may approve a retroactive effective date for the State plan amendment modifying the criteria, as early as the day following the notification period required under paragraph (c)(1) of this section, if all of the following conditions are met:
(1) The State provides at least 60 days notice of the proposed modification to the Secretary, the public, and each individual enrolled in the State plan HCBS benefit.
(2) The State notice to the Secretary is submitted as an amendment to the State plan.
(3) The adjusted needs-based eligibility criteria for the State plan HCBS benefit are less stringent than needs-based institutional and waiver LOC criteria in effect after the adjustment.
(4) Individuals who were found eligible for the State plan HCBS benefit before modification of the needs-based criteria under this adjustment authority must remain eligible for the HCBS benefit until such time as:
(i) The individual no longer meets the needs-based criteria used for the initial determination of eligibility; or
(ii) The individual is no longer eligible for or enrolled in Medicaid or the HCBS benefit.
(5) Any changes in service due to the modification of needs-based criteria under this adjustment authority are treated as actions as defined in § 431.201 of this chapter and are subject to the requirements of part 431, subpart E of this chapter.
(6) In the event that the State also needs to modify institutional level of care criteria to meet the requirements under paragraph (b) of this section that such criteria be more stringent than the State plan HCBS needs-based eligibility criteria, the State may adjust the modified institutional LOC criteria under this adjustment authority. The adjusted institutional LOC criteria must be at least as stringent as those in effect before they were modified to meet the requirements in paragraph (b) of this section.
(d) Independent evaluation and determination of eligibility. Eligibility for the State plan HCBS benefit must be determined through an independent evaluation of each individual according to the requirements of this subpart. The independent evaluation complies with the following requirements:
(1) Is performed by an agent that is independent and qualified as defined in § 441.730.
(2) Applies the needs-based eligibility criteria that the State has established under paragraph (a) of this section, and the general eligibility requirements under §§ 435.219 and 436.219 of this chapter.
(3) Includes consultation with the individual, and if applicable, the individual's representative as defined under § 441.735.
(4) Assesses the individual's support needs.
(5) Uses only current and accurate information from existing records, and obtains any additional information necessary to draw valid conclusions about the individual's support needs.
(6) Evaluations finding that an individual is not eligible for the State plan HCBS benefit are treated as actions defined in § 431.201 of this chapter and are subject to the requirements of part 431 subpart E of this chapter.
(e) Periodic redetermination. Independent reevaluations of each individual receiving the State plan HCBS benefit must be performed at least every 12 months, to determine whether the individual continues to meet eligibility requirements. Redeterminations must meet the requirements of paragraph (d) of this section.
§ 441.720   Independent assessment.
(a) Requirements. For each individual determined to be eligible for the State plan HCBS benefit, the State must provide for an independent assessment of needs, which may include the results of a standardized functional needs assessment, in order to establish a service plan. In applying the requirements of section 1915(i)(1)(F) of the Act, the State must:
(1) Perform a face-to-face assessment of the individual by an agent who is independent and qualified as defined in § 441.730, and with a person-centered process that meets the requirements of § 441.725(a) and is guided by best practice and research on effective strategies that result in improved health and quality of life outcomes.
(i) For the purposes of this section, a face-to-face assessment may include assessments performed by telemedicine, or other information technology medium, if the following conditions are met:
(A) The agent performing the assessment is independent and qualified as defined in § 441.730 and meets the provider qualifications defined by the State, including any additional qualifications or training requirements for the operation of required information technology.
(B) The individual receives appropriate support during the assessment, including the use of any necessary on-site support-staff.
(C) The individual provides informed consent for this type of assessment.
(ii) [Reserved]
(2) Conduct the assessment in consultation with the individual, and if applicable, the individual's authorized representative, and include the opportunity for the individual to identify other persons to be consulted, such as, but not limited to, the individual's spouse, family, guardian, and treating and consulting health and support professionals responsible for the individual's care.
(3) Examine the individual's relevant history including the findings from the independent evaluation of eligibility, medical records, an objective evaluation of functional ability, and any other records or information needed to develop the person-centered service plan as required in § 441.725.
(4) Include in the assessment the individual's physical, cognitive, and behavioral health care and support needs, strengths and preferences, available service and housing options, and if unpaid caregivers will be relied upon to implement any elements of the person-centered service plan, a caregiver assessment.
(5) For each service, apply the State's additional needs-based criteria (if any) that the individual may require. Individuals are considered enrolled in the State plan HCBS benefit only if they meet the eligibility and needs-based criteria for the benefit, and are also assessed to require and receive at least one home and community-based service offered under the State plan for medical assistance.
(6) Include in the assessment, if the State offers individuals the option to self-direct a State plan home and community-based service or services, any information needed for the self-directed portion of the service plan, as required in § 441.740(b), including the ability of the individual (with and without supports) to exercise budget or employer authority.
(7) Include in the assessment, for individuals receiving habilitation services, documentation that no Medicaid services are provided which would otherwise be available to the individual, specifically including but not limited to services available to the individual through a program funded under section 110 of the Rehabilitation Act of 1973, or the Individuals with Disabilities Education Improvement Act of 2004.
(8) Include in the assessment and subsequent service plan, for individuals receiving Secretary approved services under the authority of § 440.182 of this chapter, documentation that no State plan HCBS are provided which would otherwise be available to the individual through other Medicaid services or other Federally funded programs.
(9) Include in the assessment and subsequent service plan, for individuals receiving HCBS through a waiver approved under § 441.300, documentation that HCBS provided through the State plan and waiver are not duplicative.
(10) Coordinate the assessment and subsequent service plan with any other assessment or service plan required for services through a waiver authorized under section 1115 or section 1915 of the Social Security Act.
(b) Reassessments. The independent assessment of need must be conducted at least every 12 months and as needed when the individual's support needs or circumstances change significantly, in order to revise the service plan.
§ 441.725   Person-centered service plan.
(a) Person-centered planning process. Based on the independent assessment required in § 441.720, the State must develop (or approve, if the plan is developed by others) a written service plan jointly with the individual (including, for purposes of this paragraph, the individual and the individual's authorized representative if applicable). The person-centered planning process is driven by the individual. The process:
(1) Includes people chosen by the individual.
(2) Provides necessary information and support to ensure that the individual directs the process to the maximum extent possible, and is enabled to make informed choices and decisions.
(3) Is timely and occurs at times and locations of convenience to the individual.
(4) Reflects cultural considerations of the individual and is conducted by providing information in plain language and in a manner that is accessible to individuals with disabilities and persons who are limited English proficient, consistent with § 435.905(b) of this chapter.
(5) Includes strategies for solving conflict or disagreement within the process, including clear conflict of interest guidelines for all planning participants.
(6) Offers choices to the individual regarding the services and supports the individual receives and from whom.
(7) Includes a method for the individual to request updates to the plan, as needed.
(8) Records the alternative home and community-based settings that were considered by the individual.
(b) The person-centered service plan. The person-centered service plan must reflect the services and supports that are important for the individual to meet the needs identified through an assessment of functional need, as well as what is important to the individual with regard to preferences for the delivery of such services and supports. Commensurate with the level of need of the individual, and the scope of services and supports available under the State plan HCBS benefit, the written plan must:
(1) Reflect that the setting in which the individual resides is chosen by the individual. The State must ensure that the setting chosen by the individual is integrated in, and supports full access of individuals receiving Medicaid HCBS to the greater community, including opportunities to seek employment and work in competitive integrated settings, engage in community life, control personal resources, and receive services in the community to the same degree of access as individuals not receiving Medicaid HCBS.
(2) Reflect the individual's strengths and preferences.
(3) Reflect clinical and support needs as identified through an assessment of functional need.
(4) Include individually identified goals and desired outcomes.
(5) Reflect the services and supports (paid and unpaid) that will assist the individual to achieve identified goals, and the providers of those services and supports, including natural supports. Natural supports are unpaid supports that are provided voluntarily to the individual in lieu of State plan HCBS.
(6) Reflect risk factors and measures in place to minimize them, including individualized backup plans and strategies when needed.
(7) Be understandable to the individual receiving services and supports, and the individuals important in supporting him or her. At a minimum, for the written plan to be understandable, it must be written in plain language and in a manner that is accessible to individuals with disabilities and persons who are limited English proficient, consistent with § 435.905(b) of this chapter.
(8) Identify the individual and/or entity responsible for monitoring the plan.
(9) Be finalized and agreed to, with the informed consent of the individual in writing, and signed by all individuals and providers responsible for its implementation.
(10) Be distributed to the individual and other people involved in the plan.
(11) Include those services, the purchase or control of which the individual elects to self-direct, meeting the requirements of § 441.740.
(12) Prevent the provision of unnecessary or inappropriate services and supports.
(13) Document that any modification of the additional conditions, under § 441.710(a)(1)(vi)(A) through (D) of this chapter, must be supported by a specific assessed need and justified in the person-centered service plan. The following requirements must be documented in the person-centered service plan:
(i) Identify a specific and individualized assessed need.
(ii) Document the positive interventions and supports used prior to any modifications to the person-centered service plan.
(iii) Document less intrusive methods of meeting the need that have been tried but did not work.
(iv) Include a clear description of the condition that is directly proportionate to the specific assessed need.
(v) Include a regular collection and review of data to measure the ongoing effectiveness of the modification.
(vi) Include established time limits for periodic reviews to determine if the modification is still necessary or can be terminated.
(vii) Include informed consent of the individual; and
(viii) Include an assurance that the interventions and supports will cause no harm to the individual.
(c) Reviewing the person-centered service plan. The State must ensure that the person-centered service plan for every individual is reviewed, and revised as appropriate, based upon the reassessment of functional need as required in § 441.720, at least every 12 months, when the individual's circumstances or needs change significantly, and at the request of the individual. States must adhere to the requirements of § 441.301(c)(3), except that the references to section 1915(c) of the Act are instead references to section 1915(i) of the Act.
§ 441.730   Provider qualifications.
(a) Requirements. The State must provide assurances that necessary safeguards have been taken to protect the health and welfare of enrollees in State plan HCBS, and must define in writing standards for providers (both agencies and individuals) of HCBS and for agents conducting individualized independent evaluation, independent assessment, and service plan development.
(b) Conflict of interest standards. The State must define conflict of interest standards that ensure the independence of individual and agency agents who conduct (whether as a service or an administrative activity) the independent evaluation of eligibility for State plan HCBS, who are responsible for the independent assessment of need for HCBS, or who are responsible for the development of the service plan. The conflict of interest standards apply to all individuals and entities, public or private. At a minimum, these agents must not be any of the following:
(1) Related by blood or marriage to the individual, or to any paid caregiver of the individual.
(2) Financially responsible for the individual.
(3) Empowered to make financial or health-related decisions on behalf of the individual.
(4) Holding financial interest, as defined in § 411.354 of this chapter, in any entity that is paid to provide care for the individual.
(5) Providers of State plan HCBS for the individual, or those who have an interest in or are employed by a provider of State plan HCBS for the individual, except when the State demonstrates that the only willing and qualified agent to perform independent assessments and develop person-centered service plans in a geographic area also provides HCBS, and the State devises conflict of interest protections including separation of agent and provider functions within provider entities, which are described in the State plan for medical assistance and approved by the Secretary, and individuals are provided with a clear and accessible alternative dispute resolution process.
(c) Training. Qualifications for agents performing independent assessments and plans of care must include training in assessment of individuals whose physical, cognitive, or mental conditions trigger a potential need for home and community-based services and supports, and current knowledge of available resources, service options, providers, and best practices to improve health and quality of life outcomes.
§ 441.735   Definition of individual's representative.
In this subpart, the term individual's representative means, with respect to an individual being evaluated for, assessed regarding, or receiving State plan HCBS, the following:
(a) The individual's legal guardian or other person who is authorized under State law to represent the individual for the purpose of making decisions related to the person's care or well-being. In instances where state law confers decision-making authority to the individual representative, the individual will lead the service planning process to the extent possible.
(b) Any other person who is authorized under § 435.923 of this chapter, or under the policy of the State Medicaid Agency to represent the individual, including but not limited to, a parent, a family member, or an advocate for the individual.
(c) When the State authorizes representatives in accordance with paragraph (b) of this section, the State must have policies describing the process for authorization; the extent of decision-making authorized; and safeguards to ensure that the representative uses substituted judgment on behalf of the individual. State policies must address exceptions to using substituted judgment when the individual's wishes cannot be ascertained or when the individual's wishes would result in substantial harm to the individual. States may not refuse the authorized representative that the individual chooses, unless in the process of applying the requirements for authorization, the State discovers and can document evidence that the representative is not acting in accordance with these policies or cannot perform the required functions. States must continue to meet the requirements regarding the person-centered planning process at § 441.725 of this chapter.
§ 441.740   Self-directed services.
(a) State option. The State may choose to offer an election for self-directing HCBS. The term “self-directed” means, with respect to State plan HCBS listed in § 440.182 of this chapter, services that are planned and purchased under the direction and control of the individual, including the amount, duration, scope, provider, and location of the HCBS. For purposes of this paragraph, individual means the individual and, if applicable, the individual's representative as defined in § 441.735.
(b) Service plan requirement. Based on the independent assessment required in § 441.720, the State develops a service plan jointly with the individual as required in § 441.725. If the individual chooses to direct some or all HCBS, the service plan must meet the following additional requirements:
(1) Specify the State plan HCBS that the individual will be responsible for directing.
(2) Identify the methods by which the individual will plan, direct or control services, including whether the individual will exercise authority over the employment of service providers and/or authority over expenditures from the individualized budget.
(3) Include appropriate risk management techniques that explicitly recognize the roles and sharing of responsibilities in obtaining services in a self-directed manner and assure the appropriateness of this plan based upon the resources and support needs of the individual.
(4) Describe the process for facilitating voluntary and involuntary transition from self-direction including any circumstances under which transition out of self-direction is involuntary. There must be state procedures to ensure the continuity of services during the transition from self-direction to other service delivery methods.
(5) Specify the financial management supports, as required in paragraph (e) of this section, to be provided.
(c) Employer authority. If the person-centered service plan includes authority to select, manage, or dismiss providers of the State plan HCBS, the person-centered service plan must specify the authority to be exercised by the individual, any limits to the authority, and specify parties responsible for functions outside the authority the individual exercises.
(d) Budget authority. If the person-centered service plan includes an individualized budget (which identifies the dollar value of the services and supports under the control and direction of the individual), the person-centered service plan must meet the following requirements:
(1) Describe the method for calculating the dollar values in the budget, based on reliable costs and service utilization.
(2) Define a process for making adjustments in dollar values to reflect changes in an individual's assessment and service plan.
(3) Provide a procedure to evaluate expenditures under the budget.
(4) Not result in payment for medical assistance to the individual.
(e) Functions in support of self-direction. When the State elects to offer self-directed State plan HCBS, it must offer the following individualized supports to individuals receiving the services and their representatives:
(1) Information and assistance consistent with sound principles and practice of self-direction.
(2) Financial management supports to meet the following requirements:
(i) Manage Federal, State, and local employment tax, labor, worker's compensation, insurance, and other requirements that apply when the individual functions as the employer of service providers.
(ii) Make financial transactions on behalf of the individual when the individual has personal budget authority.
(iii) Maintain separate accounts for each individual's budget and provide periodic reports of expenditures against budget in a manner understandable to the individual.
(3) Voluntary training on how to select, manage, and dismiss providers of State plan HCBS.
§ 441.745   State plan HCBS administration: State responsibilities and quality improvement.
(a) State plan HCBS administration —(1) State responsibilities. The State must carry out the following responsibilities in administration of its State plan HCBS:
(i) Number served. The State will annually provide CMS with the projected number of individuals to be enrolled in the benefit and the actual number of unduplicated individuals enrolled in State plan HCBS in the previous year.
(ii) Access to services. The State must grant access to all State plan HCBS assessed to be needed in accordance with a service plan consistent with § 441.725, to individuals who have been determined to be eligible for the State plan HCBS benefit, subject to the following requirements:
(A) A State must determine that provided services meet medical necessity criteria.
(B) A State may limit access to services through targeting criteria established by § 441.710(e)(2).
(C) A State may not limit access to services based upon the income of eligible individuals, the cost of services, or the individual's location in the State.
(iii) Grievances. A State must implement and maintain a grievance process in accordance with § 441.301(c)(7), except that the references to section 1915(c) of the Act are instead references to section 1915(i) of the Act.
(iv) Appeals. A State must provide individuals with advance notice of and the right to appeal terminations, suspensions, or reductions of Medicaid eligibility or covered services as described in part 431, subpart E, of this chapter.
(v) A State must implement an incident management system in accordance with § 441.302(a)(6), except that the references to section 1915(c) of the Act are instead references to section 1915(i) of the Act.
(vi) A State must assure payment rates are adequate to ensure a sufficient direct care workforce to meet the needs of beneficiaries and provide access to services in the amount, duration, and scope specified in beneficiaries' person-centered service plans, in accordance with § 441.302(k), except that the references to section 1915(c) of the Act are instead references to section 1915(i) of the Act.
(vii) A State must assure the submission of data and information as required in § 441.302(k)(6) and § 441.311, except that the references to section 1915(c) of the Act are instead references to section 1915(i) of the Act.
(2) Administration —(i) Option for presumptive payment. (A) The State may provide for a period of presumptive payment, not to exceed 60 days, for Medicaid eligible individuals the State has reason to believe may be eligible for the State plan HCBS benefit. FFP is available for both services that meet the definition of medical assistance and necessary administrative expenditures for evaluation of eligibility for the State plan HCBS benefit under § 441.715(d) and assessment of need for specific HCBS under § 441.720(a), prior to an individual's receipt of State plan HCBS or determination of ineligibility for the benefit.
(B) If an individual the State has reason to believe may be eligible for the State plan HCBS benefit is evaluated and assessed under the presumptive payment option and found not to be eligible for the benefit, FFP is available for services that meet the definition of medical assistance and necessary administrative expenditures. The individual so determined will not be considered to have enrolled in the State plan HCBS benefit for purposes of determining the annual number of participants in the benefit.
(ii) Option for phase-in of services and eligibility. (A) In the event that a State elects to establish targeting criteria through § 441.710(e)(2), the State may limit the enrollment of individuals or the provision services to enrolled individuals based upon criteria described in a phase-in plan, subject to CMS approval. A State which elects to target the State plan HCBS benefit and to phase-in enrollment and/or services must submit a phase-in plan for approval by CMS that describes, at a minimum:
( 1 ) The criteria used to limit enrollment or service delivery.
( 2 ) The rationale for phasing-in services and/or eligibility.
( 3 ) Timelines and benchmarks to ensure that the benefit is available statewide to all eligible individuals within the initial 5-year approval.
(B) If a State elects to phase-in the enrollment of individuals based on highest need, the phase-in plan must use the needs-based criteria described in § 441.715(a) to establish priority for enrollment. Such criteria must be based upon the assessed need of individuals, with higher-need individuals receiving services prior to individuals with lower assessed need.
(C) If a State elects to phase-in the provision of any services, the phase-in plan must include a description of the services that will not be available to all eligible individuals, the rationale for limiting the provision of services, and assurance that all individuals with access to a willing and qualified provider may receive services.
(D) The plan may not include a cap on the number of enrollees.
(E) The plan must include a timeline to assure that all eligible individuals receive all included services prior to the end of the first 5-year approval period, described in paragraph (a)(2)(vi) of this section.
(iii) Reimbursement methodology. The State plan amendment to provide State plan HCBS must contain a description of the reimbursement methodology for each covered service, in accordance with CMS sub-regulatory guidance. To the extent that the reimbursement methodologies for any self-directed services differ from those descriptions, the method for setting reimbursement methodology for the self-directed services must also be described.
(iv) Operation. The State plan amendment to provide State plan HCBS must contain a description of the State Medicaid agency line of authority for operating the State plan HCBS benefit, including distribution of functions to other entities.
(v) Modifications. The agency may request that modifications to the benefit be made effective retroactive to the first day of a fiscal year quarter, or another date after the first day of a fiscal year quarter, in which the amendment is submitted, unless the amendment involves substantive change. Substantive changes may include, but are not limited to, the following:
(A) Revisions to services available under the benefit including elimination or reduction in services, and changes in the scope, amount and duration of the services.
(B) Changes in the qualifications of service providers, rate methodology, or the eligible population.
( 1 ) Request for Amendments. A request for an amendment that involves a substantive change as determined by CMS—
( i ) May only take effect on or after the date when the amendment is approved by CMS; and
( ii ) Must be accompanied by information on how the State will ensure for transitions with minimal adverse impact on individuals impacted by the change.
( 2 ) [Reserved]
(vi) Periods of approval. (A) If a State elects to establish targeting criteria through § 441.710(e)(2)(i), the approval of the State Plan Amendment will be in effect for a period of 5 years from the effective date of the amendment. To renew State plan HCBS for an additional 5-year period, the State must provide a written request for renewal to CMS at least 180 days prior to the end of the approval period. CMS approval of a renewal request is contingent upon State adherence to Federal requirements and the state meeting its objectives with respect to quality improvement and beneficiary outcomes.
(B) If a State does not elect to establish targeting criteria through § 441.710(e)(2)(i), the limitations on length of approval does not apply.
(b) Quality improvement strategy: Program performance and quality of care. States must develop and implement an HCBS quality improvement strategy that includes a continuous improvement process and measures of program performance and experience of care. The strategy must be proportionate to the scope of services in the State plan HCBS benefit and the number of individuals to be served. The State will make this information available to CMS at a frequency determined by the Secretary or upon request.
(1) Quality Improvement Strategy. The quality improvement strategy must include all of the following:
(i) Incorporate a continuous quality improvement process that includes monitoring, remediation, and quality improvement, including recognizing and reporting critical incidents, as defined in § 441.302(a)(6)(i)(A), except that the references to section 1915(c) of the Act are instead references to section 1915(i) of the Act.
(ii) Be evidence-based, and include outcome measures for program performance, quality of care, and individual experience as determined by the Secretary.
(iii) Provide evidence of the establishment of sufficient infrastructure to implement the program effectively.
(iv) Measure individual outcomes associated with the receipt of HCBS, related to the implementation of goals included in the individual service plan.
(v) Implementation of the Home and Community-Based Services Quality Measure Set in accordance with § 441.312, except that the references to section 1915(c) of the Act are instead references to section 1915(i) of the Act.
(2) [Reserved]
§ 441.750   Website transparency.
For States subject to the requirements of subpart M, the State must operate a website consistent with § 441.313, except that the references to section 1915(c) of the Act are instead references to section 1915(i) of the Act.