12VAC30-120 Waivered Services

REGULATIONS

Vol. 29 Iss. 18 - May 06, 2013

TITLE 12. HEALTH

DEPARTMENT OF MEDICAL ASSISTANCE SERVICES

Chapter 120

Fast-Track Regulation

Title of Regulation: 12VAC30-120. Waivered Services (repealing 12VAC30-120-140 through 12VAC30-120-190, 12VAC30-120-195, 12VAC30-120-201).

Statutory Authority: § 32.1-325 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: June 5, 2013.

Effective Date: June 20, 2013.

Agency Contact: Brian McCormick, Regulatory Supervisor, Department of Medical Assistance Services, 600 East Broad Street, Suite 1300, Richmond, VA 23219, telephone [phone], FAX [phone], or email [e-mail].

Basis: Section 32.1-325 of the Code of Virginia grants to the Board of Medical Assistance Services the authority to administer and amend the Plan for Medical Assistance. Section 32.1-324 of the Code of Virginia authorizes the Director of DMAS to administer and amend the Plan for Medical Assistance according to the board's requirements. The Medicaid authority as established by § 1902 (a) of the Social Security Act (42 USC § 1396a) provides governing authority for payments for services.

Purpose: This action repeals the regulations for the Medicaid HIV/AIDS waiver. This waiver's population has steadily declined from slightly more than 600 (in 1997) to now less than 25. Advances in medical treatments are enabling longer and healthier lifestyles for individuals with HIV/AIDS. As with all Medicaid § 1915(c) waivers, it must be determined to be cost effective in order to secure federal financial participation. With the declining population and the improved health of the affected individuals, this required cost effectiveness can no longer be demonstrated.

This regulatory action does not affect the health, safety, or welfare of citizens of the Commonwealth. Individuals who have been on this waiver and who continue to qualify for waiver services have been offered their choice of an alternative waiver, community care, or nursing facility placement.

This action also complies with the directive to DMAS as set out in the 2012 Acts of Assembly, Chapter 3, Item 307 JJJ, which provides: "The Department of Medical Assistance Services shall have the authority to amend the § 1915(c) home-and-community-based Elderly or Disabled with Consumer-Direction waiver, subject to approval by the Centers for Medicare and Medicaid Services to incorporate the HIV/AIDS waiver. Pending CMS approval, the HIV/AIDS waiver will cease as of June 30, 2011. The department shall implement this change effective July 1, 2012, and prior to the completion of any regulatory process undertaken in order to effect such changes."

Rationale for Using Fast-Track Process: DMAS expects this rulemaking action to be noncontroversial because the individuals who are participating will still be receiving the services that they require, just from other sources. The personal and respite care providers participate in other Medicaid waivers. There have been no private duty nursing providers used by AIDS waiver enrollees for about five years. The two remaining case management providers have only been caring for five individuals so that is not expected to constitute a major financial loss. The durable medical equipment providers who have been providing enteral nutrition services will continue to care for other Medicaid individuals who are not waiver participants.

Substance: The regulations that are affected by this action are the HIV/AIDS Waiver regulations (12VAC30-120-140 through 12VAC30-120-201). These regulations are recommended for repeal. DMAS initiated this waiver in January 1991 to initially provide personal care, respite care, case management, private duty nursing, and nutritional supplements to 80 individuals at risk of institutionalization who were either HIV symptomatic or who had diagnoses of AIDS. In 2003, the waiver was modified, with federal approval, to also cover consumer-directed personal attendant and respite services. These individuals had to meet the nursing facility level of care criteria (functionally dependent and requiring medical/nursing supervision of care) and were determined to be at risk of nursing facility placement and for whom community-based care services via the waiver were critical to enable them to remain at home.

In 1997, this waiver cared for slightly more than 600 individuals. Total expenditures at that time slightly exceeded $1.6 million with cost per individual at $2,529. Since that time, there has been a steady decline in population to today's 22 individuals.

In the last five years, only one individual, a child, has required private duty nursing services. Children who have HIV/AIDS will be able to receive private duty nursing services through the Medicaid State Plan's Early and Periodic Screening, Diagnosis, and Treatment (EPSDT) benefit (42 CFR 440-40).

Durable medical equipment providers are now able to provide enteral nutrition services to these individuals under State Plan services (12VAC30-50-165).

The Medicaid-eligible individuals who remain in this waiver are being offered their choice of either moving into the Elderly and Disabled with Consumer Direction waiver, moving into a Program of All Inclusive Care for the Elderly (PACE), accessing community services, or moving into a nursing facility. The remaining 22 individuals have made a variety of optional choices as best meets their needs.

Issues: There are no advantages or disadvantages to citizens in this repeal action. There are no advantages or disadvantages to the individuals who have been receiving care via this waiver because they will continue to have all of their needs met via either an alternative waiver, care in the community, or, at their choice, nursing facility placement.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. Pursuant to Item 307 JJJ, Chapter 3, 2012 Acts of Assembly, the proposed changes repeal the Medicaid HIV/AIDS waiver regulations.

Result of Analysis. While the proposed changes may have an adverse economic impact on a few specific individuals and providers, providing HIV/AIDS waiver services from other available sources within the Medicaid program seems to be more cost effective.

Estimated Economic Impact. Pursuant to Item 307 JJJ, Chapter 3, 2012 Acts of Assembly, the proposed changes repeal the Medicaid HIV/AIDS waiver regulations. According to the Department of Medical Assistance Services (DMAS), continued decline in the population served by the HIV/AIDS waiver made it impossible to demonstrate the cost effectiveness of this program which is necessary for renewal. Advances in medical treatments have caused the waiver population to fall to 22 as of July 2012 from more than 600 individuals in 1997. The decline in the HIV/AIDS waiver population has increased the average costs per recipient which in turn made it relatively more expensive to maintain this program compared to caring for these individuals through other available options.

The recipients had the option of moving to either the Elderly and Disabled Waiver with Consumer Direction, a Program of All-Inclusive Care for the Elderly, other community services, or nursing facility placement. Of the 22 individuals, 19 joined the EDCD waiver, two moved into nursing homes¹, and one has since been deceased. The HIV/AIDS waiver covered personal care, respite care, case management, private duty nursing, and nutritional supplements. All of these services except case management are available to the affected population from other sources. There were five individuals who utilized $2,745 worth of case management services from two providers in fiscal year 2011.

The proposed changes would represent an economic loss to the HIV/AIDS recipients when and if they need case management services. Similarly, the affected two case management providers may realize a small revenue loss. However, the affected individuals will be able to access almost all of the services from other sources. Also, while the repeal of a waiver program may free some administrative resources, DMAS plans to allocate these resources in other areas needing them. Moreover, the cost effectiveness test indicates that it is cheaper to provide these services from sources other than the HIV/AIDS waiver.

Businesses and Entities Affected. As of July 2012, there were 22 HIV/AIDS waiver recipients. Only five of these recipients had utilized case management services from two providers which will no longer be available.

Localities Particularly Affected. The proposed changes do not affect any locality more than others.

Projected Impact on Employment. The proposed changes may reduce the case management services provided and reduce the demand for administrative resources. However, the amount of reduction in case management services is very small and DMAS plans to reallocate any freed administrative services to other areas. Thus, no significant economic impact on employment is expected.

Effects on the Use and Value of Private Property. The proposed changes do not have any direct impact on the use and value of private property. The probable reduction in case management service revenues is so small that no significant adverse impact on the asset values of the affected two providers is expected.

Small Businesses: Costs and Other Effects. The proposed changes may cause a very small reduction in revenues of case management service providers.

Small Businesses: Alternative Method that Minimizes Adverse Impact. There is no known alternative method that would minimize the probable reduction in case management services.

Real Estate Development Costs. No effect on real estate development costs is expected.

Legal Mandate. The Department of Planning and Budget (DPB) has analyzed the economic impact of this proposed regulation in accordance with § 2.2-4007.04 of the Administrative Process Act and Executive Order Number 14 (10). Section 2.2-4007.04 requires that such economic impact analyses include, but need not be limited to, the projected number of businesses or other entities to whom the regulation would apply, the identity of any localities and types of businesses or other entities particularly affected, the projected number of persons and employment positions to be affected, the projected costs to affected businesses or entities to implement or comply with the regulation, and the impact on the use and value of private property. Further, if the proposed regulation has adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include (i) an identification and estimate of the number of small businesses subject to the regulation; (ii) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the regulation, including the type of professional skills necessary for preparing required reports and other documents; (iii) a statement of the probable effect of the regulation on affected small businesses; and (iv) a description of any less intrusive or less costly alternative methods of achieving the purpose of the regulation. The analysis presented above represents DPB's best estimate of these economic impacts.

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¹ These appear to be unrelated to the expiration of HIV/AIDS waiver.

Agency's Response to Economic Impact Analysis: The Department of Medical Assistance Services has reviewed the economic impact analysis prepared by the Department of Planning and Budget regarding the regulations concerning Waivered Services: Repeal HIV/AIDS Waiver (12VAC30-120-140 through 12VAC30-120-201). The agency concurs with this analysis.

Summary:

This regulatory action repeals the agency's regulations for its HIV/AIDS waiver. The regulations are no longer required as that waiver has expired. The remaining individuals who were still participating in this waiver have been given their choice of moving to either the Elderly and Disabled with Consumer Direction (EDCD) waiver, a Program of All-Inclusive Care for the Elderly (PACE), other community services, or nursing facility placement.

Part III
Home and Community-Based Services for Individuals with Acquired Immunodeficiency Syndrome (AIDS) and AIDS-Related Complex

12VAC30-120-140. Definitions. (Repealed.)

"Acquired Immune Deficiency Syndrome" or "AIDS" means the most severe manifestation of infection with the Human Immunodeficiency Virus (HIV). The Centers for Disease Control and Prevention (CDC) lists numerous opportunistic infections and cancers that, in the presence of HIV infection, constitute an AIDS diagnosis.

"Activities of daily living" or "ADL" means personal care tasks, e.g., bathing, dressing, toileting, transferring, and eating/feeding. An individual's degree of independence in performing these activities is part of determining appropriate level of care and service needs.

"Agency-directed services" means services for which the provider agency is responsible for hiring, training, supervising, and firing of the staff.

"Appeal" means the process used to challenge DMAS when it takes action or proposes to take action that will adversely affect, reduce, or terminate the receipt of benefits.

"Assistive technology" means specialized medical equipment and supplies including those devices, controls, or appliances specified in the plan of care but not available under the State Plan for Medical Assistance that enable individuals to increase their abilities to perform activities of daily living, or to perceive, control, or communicate with the environment in which they live, or that are necessary to the proper functioning of the specialized equipment. 12VAC30-120-762 provides the service description, criteria, service units and limitations, and provider requirements for this service. This service shall be available only to those AIDS waiver enrollees who are also enrolled in the Money Follows the Person demonstration program.

"Asymptomatic" means without symptoms. This term is usually used in the HIV/AIDS literature to describe an individual who has a positive reaction to one of several tests for HIV antibodies but who shows no clinical symptoms of the disease.

"Case management" means continuous reevaluation of need, monitoring of service delivery, revisions to the plan of care and coordination of services for individuals enrolled in the HIV/AIDS waiver.

"Case manager" means the person who provides services to individuals who are enrolled in the waiver that enable the continuous assessment, coordination, and monitoring of the needs of the individuals who are enrolled in the waiver. The case manager must possess a combination of work experience and relevant education that indicates that the case manager possesses the knowledge, skills, and abilities at entry level, as established by the Department of Medical Assistance Services in 12VAC30-120-170 to conduct case management.

"Cognitive impairment" means a severe deficit in mental capability that affects areas such as thought processes, problem solving, judgment, memory, or comprehension and that interferes with such things as reality orientation, ability to care for self, ability to recognize danger to self or others, or impulse control.

"Consumer-directed services" means services for which the individual or family/caregiver is responsible for hiring, training, supervising, and firing of the staff.

"Consumer-directed (CD) services facilitator" means the DMAS-enrolled provider who is responsible for supporting the individual and family/caregiver by ensuring the development and monitoring of the consumer-directed plan of care, providing employee management training, and completing ongoing review activities as required by DMAS for consumer-directed personal assistance and respite care services. The CD services facilitator cannot be the individual, the individual's case manager, direct service provider, spouse, or parent of the individual who is a minor child, or a family/caregiver who is responsible for employing the assistant.

"Current functional status" means the degree of dependency in performing activities of daily living.

"DMAS" means the Department of Medical Assistance Services.

"DMAS-96 form" means the Medicaid Funded Long-Term Care Service Authorization Form, which is a part of the preadmission screening packet and must be completed by a Level One screener on a Preadmission Screening Team. It designates the type of service the individual is eligible to receive.

"DMAS-122 form" means the Patient Information Form used by the provider and the local DSS to exchange information regarding the responsibility of a Medicaid-eligible individual to make payment toward the cost of services or other information that may affect the eligibility status of an individual.

"DSS" means the Department of Social Services.

"Designated preauthorization contractor" means the entity that has been contracted by DMAS to perform preauthorization of services.

"Enteral nutrition products" means enteral nutrition listed in the durable medical equipment manual that is prescribed by a physician to be necessary as the primary source of nutrition for the individual's health care plan (due to the prevalence of conditions of wasting, malnutrition, and dehydration) and not available through any other food program.

"Environmental modifications" means physical adaptations to a house, place of residence, primary vehicle or work site, when the work site modification exceeds reasonable accommodation requirements of the Americans with Disabilities Act (42 USC § 1201 et seq.), necessary to ensure the individuals' health and safety or enable functioning with greater independence when the adaptation is not being used to bring a substandard dwelling up to minimum habitation standards and is of direct medical or remedial benefit to individuals. 12VAC30-120-758 provides the service description, criteria, service units and limitations, and provider requirements for this service. This service shall be available only to those AIDS waiver enrollees who are also enrolled in the Money Follows the Person demonstration program.

"Fiscal agent" means an agency or organization that may be contracted by DMAS to handle employment, payroll, and tax responsibilities on behalf of the individual who is receiving consumer-directed personal assistance services and consumer-directed respite services.

"HIV-symptomatic" means having the diagnosis of HIV and having symptoms related to the HIV infection.

"Home and community-based care" means a variety of in-home and community-based services reimbursed by DMAS (case management, personal care, private duty nursing, respite care consumer-directed personal assistance, consumer-directed respite care, and enteral nutrition products) authorized under a Social Security Act § 1915(c) AIDS Waiver designed to offer individuals an alternative to inpatient hospital or nursing facility placement. Individuals may be preauthorized to receive one or more of these services either solely or in combination, based on the documented need for the service or services to avoid inpatient hospital or nursing facility placement. DMAS, or the designated preauthorization contractor, shall give prior authorization for any Medicaid-reimbursed home and community-based care.

"Human Immunodeficiency Virus (HIV)" means the virus which leads to acquired immune deficiency syndrome (AIDS). The virus weakens the body's immune system and, in doing so, allows "opportunistic" infections and diseases to attack the body.

"Instrumental activities of daily living" or "IADL" means tasks such as meal preparation, shopping, housekeeping, laundry, and money management.

"Participating provider" means an individual, institution, facility, agency, partnership, corporation, or association that has a valid contract with DMAS and meets the standards and requirements set forth by DMAS and has a current, signed provider participation agreement with DMAS to provide Medicaid waiver services.

"Personal assistance services" or "PAS" means long-term maintenance or support services necessary to enable an individual to remain at or return home rather than enter an inpatient hospital or a nursing facility. Personal assistance services include care specific to the needs of a medically stable, physically disabled individual. Personal assistance services include, but are not limited to, assistance with ADLs, bowel/bladder programs, range of motion exercises, routine wound care that does not include sterile technique, and external catheter care. Supportive services are those that substitute for the absence, loss, diminution, or impairment of a physical function. When specified, supportive services may include assistance with IADLs that are incidental to the care furnished or that are essential to the health and welfare of the individual. Personal assistance services shall not include either practical or professional nursing services as defined in § 32.1-162.7 of the Code of Virginia and 12VAC5-381-360, as appropriate.

"Personal assistant" means a domestic servant for purposes of this part and exemption from Worker's Compensation.

"Personal care agency" means a participating provider that renders services designed to offer an alternative to institutionalization by providing eligible individuals with personal care aides who provide personal care services.

"Personal care services" means long-term maintenance or support services necessary to enable the individual to remain at or return home rather than enter an inpatient hospital or a nursing facility. Personal care services are provided to individuals in the areas of activities of daily living, instrumental activities of daily living, access to the community, monitoring of self-administered medications or other medical needs, and the monitoring of health status and physical condition. It shall be provided in home and community settings to enable an individual to maintain the health status and functional skills necessary to live in the community or participate in community activities.

"Personal emergency response systems" or "PERS" means an electronic device and monitoring service that enable certain individuals at high risk of institutionalization to secure help in an emergency. PERS services are limited to those individuals who live alone or are alone for significant parts of the day and who have no regular caregiver for extended periods of time, and who would otherwise require extensive routine supervision. 12VAC30-120-970 provides the service description, criteria, service units and limitations, and provider requirements for this service.

"Plan of care" means the written plan developed by the provider related solely to the specific services required by the individual to ensure optimal health and safety for the delivery of home and community-based care.

"Preadmission Screening Authorization Form" means a part of the preadmission screening packet that must be filled out by a Level One screener on a preadmission screening team. It gives preadmission authorization to the provider and the individual for Medicaid services, and designates the type of service the individual is authorized to receive.

"Preadmission screening" or "PAS" means the process to (i) evaluate the functional, nursing, and social needs of individuals referred for preadmission screening; (ii) analyze what specific services the individuals need; (iii) evaluate whether a service or a combination of existing community services are available to meet the individuals' needs; and (iv) develop the service plan.

"Preadmission screening committee/team" or "PAS committee" or "PAS team" means the entity contracted with DMAS that is responsible for performing preadmission screening. For individuals in the community, this entity is a committee comprised of a nurse from the local health department and a social worker from the local department of social services. For individuals in an acute care facility who require preadmission screening, this entity is a team of nursing and social work staff. A physician must be a member of both the local committee and the acute care team.

"Private duty nursing" means individual and continuous nursing care provided by a registered nurse or a licensed practical nurse under the supervision of a registered nurse.

"Program" means the Virginia Medicaid program as administered by DMAS.

"Reconsideration" means the supervisory review of information submitted to DMAS or the designated preauthorization contractor in the event of a disagreement of an initial decision that is related to a denial in the reimbursement of services already rendered by a provider.

"Respite care" means services specifically designed to provide a temporary, periodic relief to the primary caregiver of an individual who is incapacitated or dependent due to AIDS. Respite care services include assistance with personal hygiene, nutritional support and environmental maintenance authorized as either episodic, temporary relief or as a routine periodic relief of the caregiver.

Consumer-directed respite care services may only be offered to individuals who have an unpaid primary caregiver who requires temporary relief to avoid institutionalization of the individual. Respite services are designed to focus on the need of the unpaid caregiver for temporary relief and to help prevent the breakdown of the unpaid caregiver due to the physical burden and emotional stress of providing continuous support and care to the individual.

"Respite care agency" means a participating provider that renders services designed to prevent or reduce inappropriate institutional care by providing eligible individuals with respite care aides who provide respite care services.

"Service plan" means the written plan of services certified by the PAS team physician as needed by the individual to ensure optimal health and safety for the delivery of home and community-based care.

"State Plan for Medical Assistance" or "the Plan" or "the State Plan" means the document containing the covered groups, covered services and their limitations, and provider reimbursement methodologies as provided for under Title XIX of the Social Security Act.

"Transition services" means set-up expenses for individuals who are transitioning from an institution or licensed or certified provider-operated living arrangement to a living arrangement in a private residence where the person is directly responsible for his own living expenses. 12VAC30-120-2010 provides the service description, criteria, service units and limitations, and provider requirements for this service.

"Uniform Assessment Instrument" or "UAI" means the standardized multidimensional questionnaire that assesses an individual's social, physical health, mental health, and functional abilities.

12VAC30-120-150. General coverage and requirements for home and community-based care services for individuals with AIDS. (Repealed.)

A. Coverage statement.

1. Coverage shall be provided under the administration of DMAS for individuals with HIV infection, who have been diagnosed and are experiencing the symptoms associated with AIDS, who would otherwise require the level of care provided in an inpatient hospital or nursing facility.

2. These services shall be medically appropriate and necessary to maintain these individuals in the community.

B. Patient eligibility requirements.

1. DMAS will apply the financial eligibility criteria contained in the State Plan for the categorically needy and the medically needy. Virginia has elected to cover the optional categorically needy group under 42 CFR 435.211, 435.231 and 435.217. The income level used for 435.211, 435.231 and 435.217 is 300% of the current Supplemental Security Income payment standard for one person.

Under this waiver, the coverage groups authorized under § 1902(a)(10)(A)(ii)(VI) of the Social Security Act will be considered as if they were institutionalized for the purpose of applying institutional deeming rules. The medically needy individuals participating in the waiver will also be considered as if they were institutionalized for the purpose of applying the institutional deeming rules.

2. Virginia will reduce its payment for home and community-based services provided to an individual who is eligible for Medicaid services under 42 CFR 435.217 by that amount of the individual's total income (including amounts disregarded in determining eligibility) that remains after allowable deductions for personal maintenance needs, deductions for other dependents and medical needs have been made, according to the guidelines in 42 CFR 435.735 and § 1915(c)(3) of the Social Security Act as amended by the Consolidated Omnibus Budget Reconciliation Act of 1986. DMAS will reduce its payment for home and community-based services provided to an individual eligible for home and community-based waiver services by the amount that remains after deducting the following amounts in the following order from the individual's income:

a. For individuals to whom § 1924(d) applies:

(1) An amount for the maintenance needs of the individual that is equal to 300% of the categorically needy income standard for a noninstitutionalized individual.

(2) For an individual with only a spouse living at home, the community spousal income allowance determined in accordance with § 1924(d) of the Social Security Act, the same as that applied for the institutionalized patient.

(3) For an individual with a family at home, an additional amount for the maintenance needs of the family determined in accordance with § 1924(d) of the Social Security Act, the same as that applied for the institutionalized patient.

(4) Amounts for incurred expenses for medical or remedial care that are not subject to payment by a third party including:

(a) Medicare and other health insurance premiums, deductibles, or coinsurance charges; and

(b) Necessary medical or remedial care recognized under state law, but not covered under the state's Medicaid Plan.

b. For all other individuals:

(1) An amount for the maintenance needs of the individual which is equal to 300% of the categorically needy income standard for a noninstitutionalized individual.

(2) For an individual with a family at home, an additional amount for the maintenance needs of the family which shall be equal to the medically needy income standard for a family of the same size.

(3) Amounts for incurred expenses for medical or remedial care that are not subject to payment by a third party including:

(a) Medicare and other health insurance premiums, deductibles, or coinsurance charges; and

(b) Necessary medical or remedial care recognized under state law, but not covered under the state's Medicaid Plan.

C. Assessment and authorization of home and community-based care services for individuals on the HIV/AIDS waiver.

1. To ensure that Virginia's home and community-based care waiver programs serve only individuals who would otherwise be placed in an inpatient hospital or nursing facility, home and community-based care services shall be considered only for individuals who meet DMAS' inpatient hospital or nursing facility criteria or for individuals who are at imminent risk, defined as within one month, of nursing facility admission. Home and community-based care services shall be the critical service that enables the individual to remain at home rather than being placed in an inpatient hospital or nursing facility.

2. The individual's eligibility for home and community-based care services shall be determined by the preadmission screening team after completion of a thorough assessment of the individual's needs and available supports. If an individual meets nursing facility or inpatient hospital criteria, the PAS team shall give the individual the choice of receiving community-based care or care in a nursing facility. In order to meet inpatient hospital criteria, the individual must have had an inpatient hospital admission within three months of the request for waiver services for an HIV-symptomatic or AIDS-related reason.

3. Before Medicaid will assume payment responsibility of home and community-based care services, preauthorization must be obtained from the designated preauthorization contractor on all services requiring preauthorization. Providers must submit the required information to the designated preauthorization contractor within 10 business days of initiating care. If the provider submits all required information to the designated preauthorization contractor within 10 business days of initiating care, services may be authorized beginning from the date the provider initiated services but not preceding the date of the physician's signature on the Medicaid Funded Long-Term Care Service Authorization Form (DMAS-96). If the provider does not submit the required information to the designated preauthorization contractor within 10 business days of initiating care, the services may be authorized beginning from the date all required information was received by the designated preauthorization contractor, but not preceding the date of the PAS team physician's signature on the DMAS-96.

4. The PAS team shall explore alternative settings and/or services to provide the care needed by the individual. If nursing facility placement or a combination of other services are determined to be appropriate, the screening team shall initiate referrals for service. If Medicaid-funded home and community-based care services are determined to be the critical services to delay or avoid inpatient hospital or nursing facility placement, the PAS team shall develop an appropriate service plan and initiate referrals for service.

5. The individual may be determined to be eligible to receive services through the HIV/AIDS waiver by the preadmission screening team if:

a. The physician who is part of the designated preadmission screening team specifically states the individual has a diagnosis of AIDS or is HIV symptomatic.

b. The preadmission screening team can document that the individual is experiencing medical and functional symptoms associated with AIDS that would, in the absence of waiver services, require the level of care provided in a hospital, or nursing facility, the cost of which would be reimbursed under the State Medicaid Plan. Individuals who would revert to a nursing facility level of care without continuation of waiver services will be allowed to continue to participate in the waiver.

6. Home and community-based care services shall not be provided to any individual who resides in a nursing facility, an intermediate care facility for the mentally retarded, a hospital, an assisted living facility licensed or certified by DSS, or a group home licensed by the Department of Mental Health, Mental Retardation and Substance Abuse Services. Additionally, home and community-based care services shall not be provided to any individual who resides outside of the physical boundaries of the Commonwealth, with the exception of brief periods of time as approved by DMAS or the designated preauthorization contractor. Brief periods of time may include, but are not necessarily restricted to, vacation or illness.

7. The average annual cost of care for home and community-based care services shall not exceed the average annual cost of inpatient hospital or nursing facility care. For purposes of this subdivision, the average annual cost of care for home and community-based care services shall include all costs of all Medicaid covered services that would actually be received by individuals. The average annual cost of nursing facility care shall be determined by DMAS and shall be updated annually.

8. Individuals should not be screened multiple times within a short period of time for the same type of service. Preadmission screenings are valid for the following periods of time: (i) months 0 up to 6 - no updates needed; (ii) months 6 up to 12 - update needed (do not submit for reimbursement); and (iii) over 12 months old - new screening must be completed (submit for reimbursement).

D. Appeals. Recipient appeals shall be considered pursuant to 12VAC30-110-10 through 12VAC30-110-380. Provider appeals shall be considered pursuant to 12VAC30-10-1000 and 12VAC30-20-500 through 12VAC30-20-560.

12VAC30-120-160. General conditions and requirements for all providers for home and community-based care services participating providers. (Repealed.)

A. All providers must meet the general requirements and conditions for provider participation. In addition, there are specific requirements for each of the service providers (case management, personal care, respite care private duty nursing, enteral nutrition, consumer-directed personal assistance services, and consumer-directed respite care services) which are set forth in 12VAC30-120-155 through 12VAC30-120-201.

B. General requirements. Providers approved for participation shall, at a minimum, perform the following activities:

1. Immediately notify DMAS, in writing, of any change in the information which the provider previously submitted to DMAS to include the provider's physical and mailing addresses, executive staff and officers, and contact person's name, telephone number, and fax number.

2. Assure freedom of choice to individuals in seeking medical care from any institution, pharmacy, practitioner, or other provider qualified to perform the service or services required and participating in the Medicaid Program at the time the service or services were performed.

3. Assure the individual's freedom to reject medical care and treatment.

4. Accept referrals for services only when staff is available to initiate services.

5. Provide services and supplies to individuals in full compliance with (i) Title VI of the Civil Rights Act of 1964 (42 USC § 2000 et seq.); (ii) § 504 of the Rehabilitation Act of 1973 (29 USC § 70 et seq.); (iii) Title II of the Americans with Disabilities Act of 1990 (42 USC § 126 et seq.); and (iv) all other applicable state and federal laws and regulations.

6. Provide services and supplies to individuals in the same quality and mode of delivery as provided to the general public.

7. Charge DMAS for the provision of services and supplies to individuals in amounts not to exceed the provider's usual and customary charges to the general public.

8. Accept Medicaid payment from the first day of eligibility.

9. Accept as payment in full the amount established by DMAS.

10. Use program-designated billing forms for submission of charges.

11. Maintain and retain business and professional records sufficient to document fully and accurately the nature, scope and details of the health care provided.

a. Such records shall be retained for at least five years from the last date of service or as provided by applicable federal or state laws, whichever period is longer. If an audit is initiated within the required retention period, the records shall be retained until the audit is completed and every exception resolved. Records of minors shall be kept for at least five years after such minor has reached the age of 18 years.

b. Policies regarding retention of records shall apply even if the provider discontinues operation. DMAS shall be notified in writing of storage, location, and procedures for obtaining records for review should the need arise. The location, agent, or trustee shall be within the Commonwealth of Virginia.

12. Furnish to authorized state and federal personnel, in the form and manner requested, access to records and facilities.

13. Disclose, as requested by DMAS, all financial, beneficial ownership, equity, surety, or other interests in any and all firms, corporations, partnerships, associations, business enterprises, joint ventures, agencies, institutions, or other legal entities providing any form of health care services to recipients of Medicaid.

14. Comply with all Health Insurance Portability and Accountability Act (HIPAA) guidelines.

15. When ownership of the provider agency changes, DMAS shall be notified within 15 calendar days prior to the date of the change.

C. Requests for participation will be screened by DMAS or the designated contractor to determine whether the provider applicant meets the basic requirements for participation.

D. For DMAS to approve contracts with home and community-based care providers, providers must meet staffing, financial solvency, disclosure of ownership and assurance of comparability of services requirements.

E. In addition to compliance with the general conditions and requirements, all providers enrolled by DMAS shall adhere to the conditions of participation outlined in their individual provider agreements and in the applicable DMAS provider service manual.

F. DMAS is responsible for assuring continued adherence to provider participation standards. DMAS shall conduct ongoing monitoring of compliance with provider participation standards and DMAS policies.

G. Individual choice of provider agencies. If there is more than one approved provider agency offering services in the community, the individual will have the option of selecting the provider agency of his choice from among those agencies that can appropriately meet the individual's needs.

H. If a participating provider wishes to voluntarily terminate his participation in Medicaid, the provider must give DMAS written notification 30 days prior to the desired termination date.

I. Termination of provider participation. DMAS may administratively terminate a provider from participation upon 30 days' written notification. DMAS may also cancel a provider agreement immediately or may give notification in the event of a breach of the provider agreement by the provider as specified in the DMAS provider agreement. Payment by DMAS is prohibited for services provided to individuals subsequent to the date specified in the termination notice. DMAS may terminate the provider's Medicaid provider agreement pursuant to § 32.1-325 of the Code of Virginia and as may be required for federal financial participation. Such provider agreement terminations shall conform to 12VAC30-10-690 and Part XII (12VAC30-20-500 et seq.) of 12VAC30-20. DMAS shall not reimburse for services that may be rendered subsequent to such terminations.

J. Reconsideration of adverse actions. Adverse actions may include, but shall not be limited to disallowed payment of claims for services rendered that are not in accordance with DMAS policies and procedures, caseload restrictions, and contract limitation or termination. The following procedures will be available to all providers when DMAS takes adverse action.

1. The reconsideration process shall consist of three phases:

a. A written response and reconsideration to the preliminary findings;

b. The informal conference; and

c. The formal evidentiary hearing.

2. The provider shall have 30 days to submit information for written reconsideration, 30 days from the date of the notice to request the informal conference, and 30 days to request the formal evidentiary hearing.

3. An appeal of adverse actions shall be heard in accordance with 12VAC30-10-1000 and Part XII (12VAC30-20-500 et seq.) of 12VAC30-20.

K. Section 32.1-325 of the Code of Virginia mandates that "Any such (Medicaid) agreement or contract shall terminate upon conviction of the provider of a felony." A provider convicted of a felony in Virginia or in any other of the 50 states or the District of Columbia must, within 30 days, notify the Virginia Medicaid Program of this conviction and relinquish its provider agreement. Reinstatement will be contingent upon provisions of the laws of the Commonwealth. Additionally, termination of a provider contract will occur as may be required for federal financial participation.

L. Participating provider agency's responsibility for the Medicaid Long Term Care Communication Form (DMAS-225). It is the responsibility of the provider agency to notify DMAS or the designated preauthorization contractor, in writing, when any of the following circumstances occur:

1. Home and community-based care services are implemented.

2. An individual receiving services dies; or

3. An individual is discharged or terminated from services.

M. Participating provider agency's responsibility for the Medicaid Long Term Care Communication Form (DMAS-225). It is the responsibility of the provider agency to notify the local DSS, in writing, when any circumstances (including hospitalization) cause home and community-based care services to cease or be interrupted for more than 30 days.

N. Changes or termination of care.

1. Decreases in the amount of authorized care.

a. The provider may decrease the amount of authorized care if the newly developed plan of care is appropriate and based on the needs of the individual. If the individual disagrees with the proposed decrease, the individual has the right to appeal to DMAS.

b. The participating provider is responsible for developing the new plan of care and calculating the new hours of service delivery.

c. The person responsible for supervising the individual's care shall discuss the decrease in care with the individual or family, document the conversation in the individual's record, and shall notify the designated preauthorization contractor and the individual or family of the change by letter. This letter shall give the individual the right to appeal.

2. Increases in the amount of authorized personal care. If a change in the individual's condition necessitates an increase in care, the participating provider shall assess the need for increase and, if appropriate, develop a plan of care for services to meet the changed needs. The provider may implement the increase in hours without approval from DMAS or the designated preauthorization contractor, if the amount of service does not exceed the amount established by DMAS or the designated preauthorization contractor, as the maximum for the level of care designated for that individual. Any increase to an individual's plan of care that exceeds the number of hours allowed for that individual's level of care or any change in the individual's level of care must be preauthorized by DMAS or the designated preauthorization contractor.

3. Nonemergency termination of home and community-based care services by the participating provider. The participating provider shall give the individual or family, or both, five days' written notification of the intent to terminate services. The letter shall provide the reasons for and effective date of the termination. The effective date of services termination shall be at least five days from the date of the termination notification letter. This includes a provider's voluntary termination of its provider agreement with DMAS.

4. Emergency termination of home and community-based care services by the participating provider. In an emergency situation when the health and safety of the individual or provider agency personnel is endangered, DMAS or the designated preauthorization contractor must be notified prior to termination. The five-day written notification period shall not be required. If appropriate, the local DSS Adult or Child Protective Services must be notified immediately.

5. Nonemergency termination of home and community-based care services by DMAS, or the designated preauthorization contractor. The effective date of termination will be at least 10 days from the date of the termination notification letter. DMAS, or the designated preauthorization contractor, has the responsibility and the authority to terminate the receipt of home and community-based care services by the individual for any of these reasons:

a. The home and community-based care services are no longer the critical alternative to prevent or delay institutional placement;

b. The individual no longer meets the level-of-care criteria;

c. The individual's environment does not provide for his health, safety, and welfare; or

d. An appropriate and cost-effective plan of care cannot be developed.

6. If the individual disagrees with the service termination decision, DMAS Appeals Division shall conduct a review of the individual's service need as part of the appeals process. The individual, when requesting an appeal, should submit documentation to indicate why the decision to deny was incorrect. As a result of this review, DMAS Appeals Division will either uphold or overturn the termination decision. If the termination decision is upheld, the individual has the right to file a formal appeal to the local circuit court. The individual filing the appeal shall have a right to the continuation of services pending the final appeal decision pursuant to 12VAC30-110-100.

O. Suspected abuse or neglect. Pursuant to §§ 63.2-1509 and 63.2-1606 through 63.2-1610 of the Code of Virginia, if a participating provider agency knows or suspects that an individual receiving home and community-based care services is being abused, neglected, or exploited, the party having knowledge or suspicion of the abuse, neglect, or exploitation shall report this immediately to the local DSS Adult Protective Services or Child Protective Services, as appropriate, and to DMAS.

P. DMAS shall conduct ongoing monitoring of compliance with provider participation standards and DMAS policies. A provider's noncompliance with DMAS regulations, policies, and procedures, as required in the provider's agreement with DMAS, may result in a denial of Medicaid payment or termination of the provider agreement.

Q. Waiver desk reviews. DMAS will request, on an annual basis, information on every individual, that is used to assess the individual's ongoing need for Medicaid-funded long-term care. With this request, the provider will receive a list that specifies the information that is being requested. If an individual is identified as not meeting criteria for the waiver, the individual will be given 10 days' notice of termination from services and be terminated from the waiver and will also be given appeal rights.

12VAC30-120-170. Case management services. (Repealed.)

A. General. Case management services are offered to enable continuous assessment, coordination and monitoring of the needs of HIV/AIDS waiver individuals. Every HIV/AIDS waiver individual authorized for home and community-based services shall be offered case management services as an adjunct to other offered services. A Medicaid-eligible individual may not be authorized for home and community-based services unless that individual is both diagnosed with AIDS or HIV and is experiencing symptoms that require delivery of a home and community-based service other than case management. An individual authorized for home and community-based services for conditions of AIDS may continue to receive case management services during periods when other home and community-based services are not being utilized as long as receipt of case management services can be shown to continue to prevent the individual's institutionalization. In instances where a case management provider cannot be located, one of the other providers (personal/respite care provider, private duty nursing provider, or consumer-directed service facilitation provider) may act as the case management provider as long as he meets the case management provider qualifications and is enrolled with DMAS to provide case management services. If an AIDS waiver individual requires case management services, this service shall be provided as a part of the AIDS waiver. There shall be no duplication of AIDS waiver case management services with other Medicaid state plan case management services.

B. Special provider participation conditions. To be a participating case management provider the following conditions shall be met:

1. The case management provider shall employ case management staff responsible for the reevaluation of need, monitoring of service delivery, revisions to the plan of care and coordination of services. Each case manager shall possess, at a minimum:

a. A bachelor's degree in human services (i.e., social work, psychology, sociology, counseling, or a related field) or nursing;

b. Knowledge of the infectious disease process (specifically HIV) and the needs of the terminally-ill population, knowledge of the community service network and eligibility requirements and the application procedures for applicable assistance programs;

c. Ability to access other health and social work professionals in the community to serve as members of a multidisciplinary team for reevaluation and coordination of services activities, ability to organize and monitor an integrated service plan for individuals with multiple problems and limited resources, ability to access (or have expertise in) medical and clinical expertise related to HIV infection and ability to demonstrate liaisons with clinical facilities providing diagnostic evaluation and/or treatment for individuals with HIV; and

d. Skills in communication, service plan development, client advocacy and monitoring of a continuum of managed care.

Documentation of all staffs' credentials shall be maintained in the provider's personnel file for review by DMAS staff. Providers of case management may utilize the services of volunteers or employees who do not meet these criteria to perform the day-to-day interactions with recipients individuals commonly included in the case management process. There shall be, however, a case manager responsible for supervision of these volunteers or employees to include at a minimum weekly case consultations, decision-making related to the individual's plan of care and appropriateness for waiver services and training of the volunteers or employees interacting with the waiver individual. The use of volunteers or other employees to perform the day-to-day interactions does not relieve the case manager from responsibility for direct contact (as defined below) with the individual and overall responsibility for care management.

2. Designate a qualified staff person as case manager who shall:

a. Complete a comprehensive initial assessment.

b. Contact the waiver individual, at a minimum, once every 30 days. If the waiver individual has a volunteer or volunteers or other staff assigned for regular face-to-face contact, this contact by the case manager may be a telephone contact. Otherwise, the contact by the case manager shall be a face-to-face interaction. At a minimum, the case manager must have face-to-face contact with the individual quarterly.

c. Contact the providers of direct waiver service or services, at a minimum, once every 30 days. Collateral contacts with other supports shall be made periodically, as determined by the needs of the individual and extent of the support system. Contacts must be documented in the individual's record.

d. Maintain a file for each individual that includes:

(1) An ongoing progress report that documents all communications between the case manager and individual, providers, and other contacts. This must include the amount of time the case manager interacted with the individual on the telephone or face to face. If the case manager is supervising a volunteer or employee who is assigned to provide day-to-day case management interactions with the individual, the volunteer or employee must submit to the case manager a monthly summary of all interactions between the volunteer or employee and the individual;

(2) The individual's assessment documentation and documentation of reassessments of level of care and need for services conducted quarterly by the case manager and the individual's case management team;

(3) The initial plan of care and all subsequent revisions; and

(4) Communication from DMAS, physician, service providers, and any other parties related to the individual's Medicaid services or medical care.

e. Review of the plan of care every three months, or more frequently if necessary, and continue any revisions indicated by the changed needs or support of the individual. These reviews shall be documented in the individual's file. The documentation shall note all members of the case management team who provided input to the plan of care.

3. Maintain a ratio of case manager staff to individual caseload that allows optimum monitoring and reevaluation ability. The caseload ability of the case manager may vary according to other duties, availability of resources, stage of individuals in caseload, and utilization of volunteers.

12VAC30-120-180. Agency-directed personal care services. (Repealed.)

A. General. Agency-directed personal care services may be offered to waiver individuals. Personal care may be offered either as the sole home and community-based care service that avoids institutionalization or in conjunction with the other AIDS waiver services. Individuals may continue to work or attend post-secondary school, or both, while they receive services under this waiver. The personal care assistant who assists the individual may accompany the individual to work or school or both and may assist the individual with personal needs while the individual is at work or school or both. DMAS will also pay for any personal care services that the assistant gives to the individual to assist him in getting ready for work or school or both or when he returns home. DMAS or the designated preauthorization contractor will review the individual's needs and the complexity of the disability when determining the services that will be provided to the individual in the workplace or school or both.

1. Effective July 1, 2011, agency-directed personal care services shall be limited to 56 hours of medically necessary services per week for 52 weeks per year.

2. Individual exceptions may be granted based on criteria established by DMAS.

B. DMAS will not duplicate services that are required as a reasonable accommodation as a part of the Americans with Disabilities Act (ADA) (42 USC §§ 12131 through 12165) or the Rehabilitation Act of 1973. For example, if the individual's only need is for assistance during lunch, DMAS would not pay for the assistant to be with the individual for any hours extending beyond lunch. For an individual whose speech is such that he cannot be understood without an interpreter (not translation of a foreign language), or the individual is physically unable to speak or make himself understood even with a communication device, the assistant's services may be necessary for the length of time the individual is at work or school or both. Workplace or school supports through the HIV/AIDS waiver are not provided if the services are an employer's responsibility under the Americans with Disabilities Act or § 504 of the Rehabilitation Act.

C. The provider agency must develop an individualized plan of care that addresses the individual's needs at home, at work or school and in the community. DMAS will not pay for the assistant to assist the enrolled individual with any functions related to the individual completing his job or school functions or for supervision time during work, school, or both.

D. Special provider participation conditions. The personal care provider shall:

1. Operate from a business office.

2. Employ (or subcontract with) and directly supervise a registered nurse who will provide ongoing supervision of all personal care aides.

a. The registered nurse shall be currently licensed to practice in the Commonwealth of Virginia and have at least two years of related clinical nursing experience (which may include work in an acute care hospital, public health clinic, home health agency, rehabilitation hospital, nursing facility, or as a licensed practical nurse (LPN)).

b. The registered nurse shall have a satisfactory work record, as evidenced by references from prior job experience, including no evidence of abuse, neglect, or exploitation of incapacitated or older adults and children. Providers are responsible for complying with § 32.1-162.9:1 of the Code of Virginia regarding criminal record checks. The criminal record check documentation shall be available for review by DMAS staff who are authorized by the agency to review these files, as a part of the utilization review process.

c. The registered nurse supervisor shall make an initial home assessment on or before the start of care for all new individuals admitted to personal care, when individuals are readmitted after being discharged from services, or are transferred from another personal care provider.

d. The registered nurse supervisor shall make supervisory visits as often as needed, but no fewer visits than provided as follows, to ensure both quality and appropriateness of services.

(1) A minimum frequency of these visits is every 30 days for individuals with a cognitive impairment, as defined herein, and every 90 days for individuals who do not have a cognitive impairment.

(2) The initial home assessment visit by the registered nurse shall be conducted to create the plan of care and assess individuals' needs. The registered nurse shall return for a follow-up visit within 30 days after the initial visit to assess the individual's needs and make a final determination that there is no cognitive impairment. This determination must be documented in the individual's record by the registered nurse. Individuals who are determined to have a cognitive impairment will continue to have supervisory visits every 30 days.

(3) If there is no cognitive impairment, the registered nurse may give the individual or caregiver or both the option of having the supervisory visit every 90 days or any increment in between, not to exceed 90 days. The registered nurse must document this conversation in the individual's record and the option that was chosen.

(4) The provider has the responsibility of determining if 30-day registered nurse supervisory visits are appropriate for the individual. The provider may offer the extended registered nurse supervisory visits, or the agency may choose to continue the 30-day supervisory visits based on the needs of the individual. The decision must be documented in the individual's record.

(5) If an individual's personal care assistant is supervised by the provider's registered nurse less often than every 30 days and DMAS or the designated preauthorization contractor determines that the individual's health, safety, or welfare is in jeopardy, DMAS or the designated preauthorization contractor may require the provider's registered nurse to supervise the personal care aide every 30 days or more frequently than what has been determined by the registered nurse. This will be documented and entered in the individual's record.

e. During visits to the individual's home, the registered nurse shall observe, evaluate, and document the adequacy and appropriateness of personal care services with regard to the individual's current functioning status, medical, and social needs. The personal care aide's record shall be reviewed and the recipient's (or family's) satisfaction with the type and amount of service discussed. The registered nurse summary shall note:

(1) Whether personal care services continue to be appropriate.

(2) Whether the plan is adequate to meet the individual's needs or if changes need to be made in the plan of care.

(3) Any special tasks performed by the aide and the aide's qualifications to perform these tasks.

(4) Individual's satisfaction with the service.

(5) Hospitalization or change in the medical condition or functioning status of the individual.

(6) Other services received by the individual and the amount; and

(7) The presence or absence of the aide in the home during the registered nurse's visit.

f. A registered nurse shall be available to the personal care aide for conference pertaining to individuals being served by the aide and shall be available to aides by telephone at all times that the aide is providing services to personal care individuals.

g. The registered nurse supervisor shall evaluate the aides' performance and the individual's needs to identify any insufficiencies in the aide's abilities to function competently and shall provide training as indicated. This shall be documented in the individual's record.

h. If there is a delay in the registered nurses' supervisory visits, because the individual was unavailable, the reason for the delay must be documented in the individual's record.

3. Employ and directly supervise personal care aides who provide direct care to personal care individuals. Each aide hired by the provider agency shall be evaluated by the provider agency to ensure compliance with qualifications required by DMAS. Each aide shall:

a. Be able to read and write.

b. Complete a minimum of 40 hours of training consistent with DMAS standards. Prior to assigning an aide to an individual, the provider agency shall ensure that the aide has satisfactorily completed a training program consistent with DMAS standards.

c. Be physically able to do the work.

d. Have a satisfactory work record, as evidenced by references from prior job experience, including no evidence of abuse, neglect or exploitation of incapacitated or older adults and children. Providers are responsible for complying with § 32.1-162.9:1 of the Code of Virginia regarding criminal record checks. The criminal record check shall be available for review by DMAS staff who are authorized by the agency to review these files; and

e. Not be (i) the parents of minor children who are receiving waiver services or (ii) spouses of individuals who are receiving waiver services.

Payment may be made for services furnished by other family members when there is objective written documentation as to why there are no other providers available to provide the care. These family members must meet the same requirements as aides who are not family members.

E. Required documentation for individuals' records. The provider agency shall maintain all records of each personal care recipient. These records shall be separate from those of nonhome and community-based care services, such as companion or home health services. These records shall be reviewed periodically by the DMAS staff who are authorized by DMAS to review these files during utilization review. At a minimum these records shall contain:

1. The most recently updated Long Term Care Uniform Assessment Instrument (UAI), documentation of any inpatient hospital admissions, the Medicaid-Funded Long-Term Care Service Authorization form (DMAS-96), the Screening Team Service Plan for Medicaid-Funded Long-Term Care (DMAS-97), the Consent to Exchange Information (DMAS-20), all Provider Agency Plans of Care (DMAS—97A), all Community-Based Care Recipient Assessment Reports (DMAS-99), all Patient Information Forms (DMAS-122), and the Service Agreement Between the Consumer and the Service Facilitator.

2. The initial assessment by a registered nurse completed prior to or on the date that services are initiated.

3. Registered nurses' notes recorded and dated during any significant contacts with the personal care aide and during supervisory visits to the individual's home.

4. All correspondence to the individual, DMAS, the designated preauthorization contractor.

5. Reassessments made during the provision of services.

6. Significant contacts made with family, physicians, DMAS, the designated preauthorization contractor, formal and informal service providers and all professionals related to the individual's Medicaid services or medical care.

7. All Provider Aide/LPN Records (DMAS-90). The Provider Aide/LPN Record shall contain:

a. The specific services delivered to the individual by the aide and the individual's response to this service;

b. The aide's daily arrival and departure times;

c. The aide's weekly comments or observations about the individual, including observations of the individual's physical and emotional condition, daily activities, and responses to services rendered; and

d. The aide's and individual's, or responsible caregiver's, weekly signatures, including the date, to verify that personal care services have been rendered during that week as documented in the record. An employee of the provider cannot sign for the individual unless he is a family member or legal guardian of the individual.

Signatures, times and dates shall not be placed on the aide record prior to the last date of the week that the services are delivered.

8. All individual progress reports.

12VAC30-120-190. Agency-directed respite care services. (Repealed.)

A. General. Agency-directed respite care services may be offered to individuals as an alternative to institutional care. Respite care may be offered to individuals in their homes or places of residence, in a Medicaid-certified nursing facility, or in a licensed respite care facility. Respite care is distinguished from other services in the continuum of long-term care because it is specifically designed to focus on the need of the unpaid primary caregiver for temporary relief. Respite care may only be offered to individuals who have an unpaid primary caregiver living in the home who requires temporary relief to avoid institutionalization of the individual. Effective July 1, 2011, the authorization of respite care is limited to 480 hours per year per individual. An individual who transfers to a different provider or is discharged and readmitted into the HIV/AIDS waiver program within the same year will not receive an additional 480 hours of respite care. Reimbursement shall be made on an hourly basis not to exceed a total of 480 hours per year. If an individual is receiving both agency directed and consumer directed respite care, the total number of respite care hours cannot exceed a total of 480 hours combined per year.

B. Special provider participation conditions. To be approved for respite care contracts with DMAS, the respite care provider shall:

1. Operate from a business office.

2. Employ (or subcontract) with and directly supervise a registered nurse who will provide ongoing supervision of all respite care aides.

a. The registered nurse shall be currently licensed to practice in the Commonwealth and have at least two years of related clinical nursing experience which may include work in an acute care hospital, public health clinic, home health agency, rehabilitation hospital, nursing facility or as an LPN.

b. The registered nurse shall have a satisfactory work record, as evidenced by references from prior job experience, including no evidence of abuse, neglect, or exploitation of incapacitated or older adults and children. Providers are responsible for complying with § 32.1-162.9:1 of the Code of Virginia regarding criminal record checks. The criminal record check shall be available for review by DMAS staff who are authorized by the agency to review these files.

c. Based on continuing evaluations of the aides' performance and the individuals' needs, a registered nurse supervisor shall identify any insufficiencies in the aides' abilities to function competently and shall provide training as indicated.

d. A registered nurse supervisor shall make an initial home assessment visit on or before the start of care for any individual admitted to respite care.

e. A registered nurse supervisor shall make supervisory visits as often as needed to ensure both quality and appropriateness of services.

(1) When respite care services are received on a routine basis, the minimum acceptable frequency of these visits shall be every 30 days.

(2) When respite care services are not received on a routine basis, but are episodic in nature, a registered nurse shall not be required to conduct a supervisory visit every 30 days. Instead, a registered nurse shall conduct the initial home visit with the respite care aide on or before the start of care and make a second home visit during the second respite care visit.

(3) When respite care services are routine in nature and offered in conjunction with personal care, the supervisory visit conducted for personal care services may serve as the registered nurse supervisory visit for respite care. However, the registered nurse supervisor shall document supervision of respite care separately from the personal care documentation. For this purpose, the same individual record can be used with a separate section for respite care documentation.

f. During visits to the individual's home, the registered nurse shall observe, evaluate, and document the adequacy and appropriateness of respite care services with regard to the individual's current functioning status, medical, and social needs. The respite care aide's record shall be reviewed and the recipient's or family's satisfaction with the type and amount of service discussed. The registered nurse shall document in a summary note:

(1) Whether respite care services continue to be appropriate;

(2) Whether the plan of care is adequate to meet the individual's needs or if changes need to be made in the plan of care;

(3) The individual's satisfaction with the service;

(4) Any hospitalization or change in the medical condition or functioning status of the individual;

(5) Other services received by the individual and the amount of services received; and

(6) The presence or absence of the aide in the home during the registered nurse's visit.

g. A registered nurse shall be available to the respite care aide for conference pertaining to individuals being served by the aide and shall be available to the aides by telephone at all times that aides are providing services to respite care individuals.

h. If there is a delay in the registered nurse's supervisory visits because the individual is unavailable, the reason for the delay must be documented in the individual's record.

3. Employ and directly supervise respite care aides who provide direct care to respite care individuals. Each aide hired by the provider agency shall be evaluated by the provider agency to ensure compliance with qualifications as required by DMAS. Each aide must:

a. Be able to read and write in English to the degree necessary to perform the tasks expected.

b. Have completed a minimum 40 hours of training consistent with DMAS standards. Prior to assigning an aide to an individual, the provider agency shall ensure that the aide has satisfactorily completed a training program consistent with DMAS standards.

c. Be evaluated in his job performance by the registered nurse supervisor.

d. Be physically able to do the work.

e. Have a satisfactory work record, as evidenced by references from prior job experience, including no evidence of abuse, neglect, or exploitation of incapacitated or older adults and children. Providers are responsible for complying with § 32.1-162.9:1 of the Code of Virginia regarding criminal record checks. The criminal record check documentation shall be available for review by DMAS staff who are authorized by the agency to review these files.

f. Not be (i) the parents of minor children who are receiving waiver services or (ii) the spouses of individuals who are receiving waiver services.

Payment may be made for services furnished by other family members when there is objective written documentation as to why there are no other providers available to provide the care. These family members must meet the same requirements as aides who are not family members.

4. The respite care agency may employ a licensed practical nurse (LPN) to perform skilled respite care services which shall be reimbursed by DMAS under the following circumstances:

a. The LPN shall be currently licensed to practice in the Commonwealth. The LPN must have a satisfactory work record, as evidenced by references from prior job experience, including no evidence of abuse, neglect, or exploitation of incapacitated or older adults and children. Providers shall be responsible for complying with § 32.1-162.9:1 of the Code of Virginia regarding criminal record checks. The criminal record check documentation shall be available for review by DMAS staff who are authorized by the agency to review these files.

b. The individual has a need for routine skilled care that cannot be provided by unlicensed personnel. This individual would typically require a skilled level of care if in a nursing facility (i.e., individuals on a ventilator, individuals requiring nasogastric or gastrostomy feedings, etc.).

c. No other person in the individual's support system is able to supply the skilled component of the individual's care during the caregiver's absence.

d. The individual is unable to receive skilled nursing visits from any other source which could provide the skilled care usually given by the caregiver.

e. The agency must document in the individual's record the circumstances which require the provision of services by an LPN.

f. A physician's order for the skilled respite service, on the Home Health Certification and Plan of Care (CMS-485) is obtained prior to the initiation of service and is updated every six months. This order must specifically identify the skilled tasks to be performed.

The registered nurse shall review the medications and treatments rendered by the LPN every 60 days and verify the physician's orders.

C. Required documentation for individuals' records. The provider agency shall maintain all records of each respite care individual. These records shall be separate from those of nonhome and community-based care services, such as companion or home health services. These records shall be reviewed periodically by the DMAS staff who are authorized by the agency to review these files during utilization review. At a minimum these records shall contain:

1. The most recently updated Long Term Care Uniform Assessment Instrument (UAI), documentation of any inpatient hospital admissions, the Medicaid-Funded Long-Term Care Service Authorization form (DMAS-96), the Screening Team Service Plan for Medicaid-Funded Long-Term Care (DMAS-97), all Community-Based Care Assessment Reports (DMAS-99), all Provider Agency Plans of Care (DMAS-97A and CMS-485), and all Patient Information Forms (DMAS-122) .

2. The initial assessment by a registered nurse completed prior to or on the date services are initiated.

3. Registered nurse's notes recorded and dated during significant contacts with the respite care aide or LPN and during supervisory visits to the individual's home.

4. All correspondence to the individual, DMAS, and the designated preauthorization contractor.

5. Reassessments made during the provision of services.

6. Significant contacts made with family, physicians, DMAS, the designated preauthorization contractor, formal and informal service providers, and all professionals related to the individual's Medicaid services or medical care.

7. All Provider Aide/LPN Records (DMAS-90). The provider aide/LPN record shall contain:

a. The specific services delivered to the individual by the respite care aide, or LPN, and the individual's response to this service.

b. The daily arrival and departure times of the aide or LPN for respite care services.

c. Comments or observations recorded weekly about the individual. Aide or LPN comments shall include but not be limited to observation of the individual's physical and emotional condition, daily activities, and the individual's response to services rendered.

d. The signatures of the aide, or LPN, and the individual once each week to verify that respite care services have been rendered.

Signatures, times, and dates shall not be placed on the aide record prior to the last date of the week that the services are delivered. If the individual is unable to sign the aide record, it must be documented in the individual's record how or who will sign in his place. An employee of the provider shall not sign for the individual unless he is a family member or legal guardian of the individual and has direct knowledge of the care received by the individual.

8. All recipient progress reports.

12VAC30-120-195. Enteral nutrition products. (Repealed.)

A. General requirements and conditions.

1. Enteral nutrition products shall only be provided by enrolled durable medical equipment (DME) providers as defined in 12VAC30-50-165.

2. DME providers shall adhere to all applicable DMAS policies, laws, and regulations for enteral nutrition products. DME providers shall also comply with all other applicable Virginia laws and regulations requiring licensing, registration, or permitting. Failure to comply with such laws and regulations shall result in denial of coverage for enteral nutrition that is regulated by such licensing agency or agencies.

B. Service units and service limitations.

1. DME and supplies must be furnished pursuant to the AIDS Waiver Enteral Nutrition Evaluation Form (DMAS-116).

2. A DMAS-116 shall be required for all AIDS waiver recipients receiving enteral nutrition products. Enteral nutrition products that do not contain a legend drug may be obtained for the individual receiving waiver services for conditions of AIDS and HIV-symptomatic when the enteral nutrition product is certified by the practitioner as the primary source of nutrition, is administered orally or through a nasogastric or gastrostomy tube, and is necessary for the successful implementation of the individual's health care plan and the individual is not able to purchase enteral nutrition products through other means. Coverage of enteral nutrition products does not include the provision of routine infant formula. The amount of enteral nutrition products that shall be reimbursed by Medicaid shall be limited by medical necessity and cost effectiveness.

3. "Primary source" means that enteral nutrition products are medically indicated for the treatment of the individual's condition if the individual is unable to tolerate other forms of nutrition. The individual may either be unable to take any oral nutrition or the oral intake that can be tolerated is inadequate to sustain life. The focus must be on the maintenance of weight and strength commensurate with the individual's medical condition.

4. The DMAS-116 shall contain a practitioner's order for the enteral nutrition products that are medically necessary to treat the diagnosed condition and the individual's functional limitation. The order for enteral nutrition products must be justified in the written documentation either on the DMAS-116 or attached thereto. The DMAS-116 shall be valid for a maximum period of six months. The validity of the DMAS-116 shall terminate when the individual's medical need for the prescribed enteral nutrition products either ends or when the enteral nutrition products are no longer the primary source of nutrition.

5. A face-to-face nutritional assessment completed by trained clinicians (e.g., physician, physician assistant, nurse practitioner, registered nurse, or a registered dietitian) must be completed as required documentation of the need for enteral nutrition products for both the initial order and every six months. The DMAS-116 is required every six months.

6. The DMAS-116 shall not be changed, altered, or amended after the practitioner has signed it. As indicated by the individual's condition, if changes are necessary in the ordered enteral nutrition products, the DME provider must obtain a new DMAS-116. New DMAS-116s must be signed and dated by the practitioner within 60 days from the time the ordered enteral nutrition products are furnished by the DME provider. The order cannot be back-dated to cover prior dispensing of enteral nutrition products. If the order is not signed within 60 days of the service initiation, then the date the order is signed becomes the effective date.

7. Preauthorization of enteral nutrition products is not required. The DME provider must assure that there is a valid DMAS-116 completed every six months in accordance with DMAS policy and on file for all Medicaid individuals for whom enteral nutrition products are provided. The DME provider is further responsible for assuring that enteral nutrition products are provided in accordance with DMAS reimbursement criteria. Upon post payment review, DMAS will deny reimbursement for any enteral nutrition products that have not been provided and billed in accordance with these regulations.

8. DMAS shall have the authority to determine that the DMAS-116 is valid for less than six months based on medical documentation submitted.

C. Provider responsibilities.

1. The DME provider must provide the enteral nutrition products as prescribed by the practitioner on the DMAS-116. Orders shall not be changed unless the DME provider obtains a new DMAS-116 prior to ordering or providing the enteral nutrition products to the individual.

2. The practitioner's order (DMAS-116) must state that the enteral nutrition products are the primary source of nutrition for the individual and specify either a brand name of the enteral nutrition product being ordered or the category of enteral nutrition products that must be provided. If a practitioner orders a specific brand of enteral nutrition product, the DME provider must supply the brand prescribed. The practitioner order must include the daily caloric order and the route of administration for the enteral nutrition product. Supporting documentation may be attached to the DMAS-116 but the entire order must be on the DMAS-116.

3. Enteral nutrition products must be furnished exactly as ordered by the practitioner on the DMAS-116. The DMAS-116 and any supporting verifiable documentation must be complete (signed and dated by the practitioner) and in the DME provider's possession within 60 days from the time the ordered enteral nutrition product is initially furnished by the DME provider.

4. The DMAS-116 may be completed by the registered nurse, registered dietitian, physician, physician assistant, or nurse practitioner, but it must be signed and dated by the physician.

5. The DMAS-116 must be signed and dated by the assessor and the practitioner within 60 days of the DMAS-116 begin service date. If the DMAS-116 is not signed and dated by the assessor and the practitioner within 60 days of the DMAS-116 begin service date, the DMAS-116 will not become valid until the date of the practitioner's signature.

6. The DMAS-116 must include all of the following elements:

a. Height (or length for pediatric patients);

b. Weight. For initial assessments, indicate the individual's weight loss over time;

c. Tolerance of enteral nutrition product (e.g., is the individual experiencing diarrhea, vomiting, constipation). This element is only required if the individual is already receiving enteral nutrition products;

d. Indication of whether or not the enteral nutrition product is the primary or sole source of nutrition;

e. Route of administration;

f. The daily caloric order and the number of calories per package, can, etc.;

g. Extent to which the quantity of the enteral nutrition product is available through WIC; and

h. Title, signature, and date of the assessor and the practitioner.

7. The DME provider shall retain a copy of the DMAS-116 and all supporting verifiable documentation on file for DMAS' post payment review purposes. DME providers shall not create or revise DMAS-116s or supporting documentation for this service after the initiation of the post payment review process. Practitioners shall not complete, or sign and date, DMAS-116s once the post payment review has begun.

8. DME providers shall retain copies of the DMAS-116 and all applicable supporting documentation on file for post payment reviews. Enteral nutrition products that are not ordered on the DMAS-116 for which reimbursement has been made by Medicaid will be denied. Supporting documentation is allowed to justify the medical need for enteral nutrition products. Supporting documentation does not replace the requirement of a properly completed DMAS-116. The dates of the supporting documentation must coincide with the dates of service on the DMAS-116 and the medical practitioner providing the supporting documentation must be identified by name and title. DME providers shall not create or revise DMAS-116s or supporting documentation for enteral nutrition products provided after the post payment review has been initiated.

9. To receive reimbursement, the DME provider is expected to:

a. Deliver only the item or items ordered by the practitioner and approved by DMAS or the designated preauthorization contractor;

b. Deliver only the quantities ordered by the practitioner and approved by DMAS or the designated preauthorization contractor;

c. Deliver only the item or items for the periods of service covered by the practitioner's order and approved by DMAS or the designated preauthorization contractor;

d. Maintain a copy of the practitioner's order and all verifiable supporting documentation for all DME ordered; and

e. Document all supplies provided to an individual in accordance with the practitioner's orders. The delivery ticket must document the individual's name and Medicaid number, the date of delivery, what was delivered, and the quantity delivered.

10. DMAS will deny payment to the DME provider if any of the following occur:

a. No presence of a current, fully completed DMAS-116 appropriately signed and dated by the practitioner;

b. Documentation does not verify that the item was provided to the individual;

c. Lack of medical documentation, signed by the practitioner to justify the enteral nutrition products; or

d. Item is noncovered or does not meet DMAS criteria for reimbursement.

11. The enteral nutrition product vendor must provide the supplies as prescribed by the practitioner on the DMAS-116. Orders shall not be changed unless the vendor obtains a new DMAS-116 prior to ordering or providing the enteral nutrition product to the individual.

12. Medicaid shall not provide reimbursement to the vendor for services provided prior to the date prescribed by the practitioner or prior to the date of the delivery or when services are not provided in accordance with published policies and procedures. If reimbursement is denied for one of these reasons, the DME provider may not bill the Medicaid recipient for the service that was provided.

13. The following criteria must be satisfied through the submission of adequate and verifiable documentation satisfactory to DMAS. Medically necessary DME and supplies shall be;

a. Ordered by the practitioner on the DMAS-116;

b. A reasonable and necessary part of the individual's treatment plan;

c. Consistent with the individual's diagnosis and medical condition, particularly the functional limitations and symptoms exhibited by the individual;

d. Not furnished solely for the convenience, safety, or restraint of the individual, the family, attending practitioner, or other practitioner or supplier;

e. Consistent with generally accepted professional medical standards (i.e., not experimental or investigational); and

f. Furnished at a safe, efficacious, and cost-effective level suitable for use in the individual's home environment.

12VAC30-120-201. Private duty nursing services. (Repealed.)

A. General. Private duty nursing services shall be offered to individuals enrolled in the HIV/AIDS waiver when such services are deemed necessary by the attending physician to avoid institutionalization by assessing and monitoring the medical condition, providing interventions, and communicating with the physician regarding changes in the individual's status. The hours of private duty nursing shall be limited by medical necessity. The purpose of private duty nursing is to provide for ongoing monitoring, continued nursing supervision, and skilled care. This service should not be authorized when intermittent skilled nursing visits could be utilized. Private duty nursing services should not be provided simultaneously with LPN respite care.

B. Special provider participation conditions. To be approved for private duty nursing contracts with DMAS, the private duty nursing provider shall:

1. Be a home health agency licensed or certified by the Virginia Department of Health for Medicaid participation and with which DMAS has a signed participation agreement for private duty nursing services.

2. Demonstrate prior successful health care delivery.

3. Operate from a business office.

4. Employ (or subcontract with) and directly supervise a registered nurse or a licensed practical nurse.

a. The registered nurse shall be currently licensed to practice in the Commonwealth and have at least two years of related clinical nursing experience, which may include work in an acute care hospital, public health clinic, home health agency, rehabilitation hospital, nursing facility, or as an LPN.

b. The LPN shall be currently licensed to practice in the Commonwealth.

C. Limits to services.

1. Private duty nursing shall be reimbursed for a maximum of 16 hours within a 24-hour period per household.

2. In no instance shall the designated preauthorization contractor approve an ongoing plan of care or ongoing multiple plans of care per household that result in approval of more than 16 hours of private duty nursing in a 24-hour period per household.

3. Congregate private duty nursing. When two waiver individuals share a residence, there shall be a maximum ratio of one private duty nurse to two waiver individuals. When three or more waiver individuals share a residence, ratios will be determined by the combined needs of the individuals.

D. Provider reimbursement.

1. All private duty nursing services shall be reimbursed at an hourly rate determined by DMAS.

2. If the AIDS Waiver individual needs skilled nursing and has another payer (Medicare or private insurance), the skilled nursing must be covered by the other payer or payers first. Whatever skilled nursing services are not covered under the primary insurance, Medicaid may cover. There shall be no duplication of nursing services with other payers or other Medicaid State Plan services.

3. RN/LPN shall not practice without signed physician orders specifically identifying skilled tasks to be performed for the individual.

4. The registered nurse shall review the medications and treatments rendered by the LPN every 60 days and verify the physician's orders.

E. Assessment and plan of care requirements.

1. The case manager shall be responsible for ensuring that the assessment, care planning, monitoring, and review activities required by DMAS are accomplished and documented, consistent with DMAS requirements.

2. Development of the plan of care.

a. Upon completion of the required assessments and a determination that the individual needs substantial and ongoing skilled nursing care, the hours of nursing service required shall be developed and approved by the designated preauthorization contractor.

b. At a minimum, the plan of care shall include:

(1) Identification of the type, frequency, and amount of nursing care needed. This shall include the name of the provider agency, whether the nurse is an RN or LPN, and verification that the nurse is licensed to practice in the Commonwealth.

(2) Identification of the type, frequency, and amount of care that the family or other informal caregivers shall provide.

F. Individual selection of waiver services.

1. The case manager shall give the legally competent individual, or the individual's legal guardian, or the parent of a minor child, the choice of waiver services or institutionalization. This choice must be documented.

2. If waiver services are chosen, the individual applicant or his legally responsible entity will also be given the opportunity to choose the providers of services if more than one provider is available to render the services. This choice must also be documented. If more than one waiver individual will reside in the home, one waiver provider shall be chosen to provide all private duty nursing services for all waiver individuals in the home. Only one nurse will be authorized to care for every two waiver individuals in a residence. In the instance when more than two waiver individuals share a residence, nursing ratios will be determined by the designated preauthorization contractor based on the needs of all the individual living together.

3. The designated preauthorization contractor or DMAS shall review and approve the assessment and plan of care prior to the individual's admission to community waiver services, and prior to Medicaid payment for any services related to the waiver plan of care.

G. Reevaluation requirements and utilization review.

1. The need for reevaluations shall be determined by the case manager, registered nurse, DMAS, or the designated preauthorization contractor. Reevaluations shall be conducted by these professionals as required by the individual's needs and situation and at any time when a change in the individual's condition indicates the need for reevaluation.

2. Utilization review shall be conducted by DMAS on all providers to ensure consumer satisfaction, the adherence to state and federal provider qualifications, and documentation requirements. DMAS will also ensure the appropriate billing practices for waiver services.

H. Registered nurse supervisory duties.

1. The registered nurse shall make, at a minimum, a visit every 30 days to the individual's home to assess the individual's/caregiver's satisfaction with the services being provided.

2. The registered nurse shall review medications and treatments rendered by the private duty nurse every 60 days and verify orders with the physician signature.

3. The registered nurse shall review all discharge orders written upon the individual's discharge from the hospital and provide a copy of such orders to the private duty nurse rendering care to the individual in his home.

a. The RN shall make an initial assessment visit prior to the start of care for any individual admitted to private duty nursing.

b. During visits to the individual's home, the registered nurse shall observe, evaluate, and document the adequacy and appropriateness of private duty nursing services with regard to the individual's current functioning status, medical, and social needs. The individual's or family's satisfaction with the type and amount of service must be discussed. The registered nurse shall document in a summary note:

(1) Whether private duty nursing services continue to be appropriate;

(2) Whether the plan of care is adequate to meet the individual's needs or if changes need to be made to the plan of care;

(3) The individual's satisfaction with the service;

(4) Any hospitalization or change in the medical condition or functioning status of the individual; and

(5) Other services received and their amount.

I. Required documentation for individuals' records. The provider agency shall maintain all records of each individual receiving private duty nursing. These records shall be separate from those of other nonhome and community-based care services, such as companion or home health services. These records shall be reviewed periodically by the DMAS staff who are authorized by DMAS to review these files during utilization review. At a minimum, the record shall contain:

1. The most recently updated Long-Term Care Uniform Assessment Instrument (UAI), documentation of any inpatient hospital admissions, the Medicaid-Funded Long-Term Care Service Authorization Form (DMAS-96), the Screening Team Service Plan for Medicaid-Funded Long-Term Care (DMAS-97), all Home Health Certification and Plans of Care (CMS-485), Skills Checklist for Private Duty Nursing (DMAS-259), all Patient Information Forms (DMAS-122) and all signed physician's orders.

2. The initial assessment by the registered nurse completed prior to or on the date services were initiated.

3. Registered nurses' notes recorded and dated during visits to the individual's home. The registered nurses' notes shall contain:

a. The specific services delivered to the individual and the individual's response;

b. Comments or observations about the individual. Comments shall include but not be limited to observation of the individual's physical and emotional condition, daily activities, and the individual's response to the services rendered;

c. The signature by the registered nurse or the licensed practical nurse and the individual at least once a week to verify that private duty nursing services have been rendered. This record must be maintained in the individual's record.

4. All correspondence to the individual, DMAS, and the designated preauthorization contractor.

5. Reassessments made during the provision of services.

6. Significant contacts made with family, physicians, DMAS, the designated preauthorization contractor, formal and informal service providers and all professionals related to the individual's Medicaid services or medical care.

Copies of all nurses' records shall be subject to review by state and federal Medicaid representatives.

If an individual who is receiving private duty nursing is also receiving any other service (meals on wheels, companion, home health services, etc.), the nurse record shall indicate that these services are also being received by the individual.

There should be no duplication of nursing services with other Medicaid State Plan services or payors.

VA.R. Doc. No. R13-3218; Filed April 17, 2013, 10:28 a.m.