REGDRAFT.DOT

TITLE 12. HEALTH

DEPARTMENT OF MEDICAL ASSISTANCE SERVICES

Fast-Track Regulation

Titles of Regulations: 12VAC30-50. Amount, Duration, and Scope of Medical and Remedial Care Services (amending 12VAC30-50-320; adding 12VAC30-50-330 through 12VAC30-50-360).

12VAC30-120. Waivered Services (repealing 12VAC30-120-61 through 12VAC30-120-68).

Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396.

Public Hearing Information: No public hearings are scheduled.

Public Comments: Public comments may be submitted until 5 p.m. on January 21, 2009.

Effective Date: February 5, 2009.

Agency Contact: Deborah Pegram, Long-Term Care Services Division, Department of Medical Assistance Services, 600 East Broad Street, Suite 1300, Richmond, VA 23219, telephone (804) 371-2912, FAX (804) 786-1680, or email deborah.pegram@dmas.virginia.gov.

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: The amended regulation is required in order to meet CMS’ requirements to have the PACE program categorized as a State Plan optional service and not a waiver service. These regulations must be promulgated to accomplish this action.

The purpose of PACE is to provide a community-based alternative to nursing facility care that integrates primary and long-term care services within Medicaid, but excludes Medicare financing and services. Sentara Senior Community Care, a pre-PACE provider in the Tidewater area, served 122 enrolled participants in FY 06 at a cost of $3.4 million for an average of approximately $27,655 per person. PACE combines Medicaid and Medicare funding to provide all medical, social, and long-term care services through an adult day health care center (ADHC). The pre-PACE and PACE programs allows elders to remain in familiar surroundings; maintain self-sufficiency; and preserve the highest level of physical, social, and cognitive function and independence. A nursing facility preadmission screening team must authorize PACE services. In order to continue the PACE program DMAS must move the PACE regulations out of the waiver services section of the Virginia Administrative Code and into the State Plan services section of the Administrative Code.

Rationale for Using Fast-Track Process: The fast-track regulatory process is required in order to bring the PACE regulation into compliance with DMAS' approved State Plan amendment. Except as noted for 12VAC30-120-67 in the "Substance" statement below, no language is being substantively amended; technical and grammatical changes are being recommended in four places. The primary intent of the proposed action is to move the PACE regulation from the waiver section of DMAS regulations to the State Plan section.

Substance: 12VAC30-120-67, PACE catastrophic coverage limitation, is being repealed. The remaining PACE regulations are being moved from the waiver section to the State Plan section.

In addition, four technical changes are being recommended:

1. In the "Definitions" section (12VAC30-50-330), "all" is added to the "capitation rate" definition to clarify that all necessary services are provided to PACE participants within the negotiated monthly per capita amount. This is the original intent and is clearly stated in the Request for Proposals.

2. In the "Definitions" section, "by" is added to the definition for the "PACE plan feasibility study" to correct a grammatical error.

3. Also in the "Definitions" section, "provider" is defined. The definition is taken from other existing waiver regulations and was inadvertently omitted.

4. In response to a request by the Centers for Medicare and Medicaid (CMS), in the "General PACE Plan Requirements" section at 12VAC30-50-335, "prior to the beginning of employment" is added to the existing requirement for the criminal record check process for providers and employees. This clarifies the intent of the existing language and brings the regulation into compliance with CMS requirements.

Issues: The movement of this regulation is to maintain department efforts to improve the infrastructure for community-based long-term support services by making the PACE regulation a State Plan option, allowing the state additional flexibility within the program. The PACE program creates a system of long-term services and supports that enables the elderly to remain in the community rather than in a more costly and less restrictive institutional setting.

This proposal supports Virginia’s implementation of the Olmstead decision and complements the efforts of the recently awarded Systems Transformation Grant and Money Follows the Person Demonstration that both intend to improve the infrastructure for community-based long-term support services.

There are no disadvantages to the public or the Commonwealth.

This proposed regulatory action will have a positive impact on families in allowing individuals facing institutional placement an additional home and community-based option.

The Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The proposed changes will move the PACE regulations from the waiver section of Medicaid regulations to the State Plan for Medical Assistance Services section.

Result of Analysis. The benefits likely exceed the costs for all proposed changes.

Estimated Economic Impact. Program of All-Inclusive Care for the Elderly (PACE) provides community based services that are alternative to nursing facility care to the recipients through an adult day health care center.

The PACE program started as a waiver program and its rules were placed in the waiver section of Medicaid regulations (12VAC30-120). On January 1, 2007, the Centers for Medicare and Medicaid (CMS) allowed Virginia to offer PACE program as an optional State Plan service rather than a waiver service. Consequently, the proposed changes will move the PACE rules into the section of Medicaid regulations where State Option service regulations are housed (12VAC30-50).

A waiver service, unlike a state plan service, waives either one of the three primary federal limitations: statewideness; comparability of services, and free choice of providers. So, making a waiver service a state plan service would normally mean a change in statewideness, comparability of services, or free choice of providers. However, in this particular case, CMS granted exemptions so that there was no change in statewideness, comparability of services, and free choice of providers. In short, the proposed movement of the regulations will produce no change in practice. Thus, no significant economic effect is expected from the proposed regulations other than providing a small benefit in terms of the consistency in housing all of the state option services under the same section.

Businesses and Entities Affected. The proposed regulations apply to PACE providers and recipients. In 2006, there were one provider and 122 enrollees.

Localities Particularly Affected. The regulations apply throughout the Commonwealth, but, the only provider was located in Tidewater area.

Projected Impact on Employment. No significant effect on employment is expected.

Effects on the Use and Value of Private Property. No significant effect on the use and value of private property is expected.

Small Businesses: Costs and Other Effects. Proposed regulations have no costs or other effects on small businesses.

Small Businesses: Alternative Method that Minimizes Adverse Impact. Proposed regulations have no adverse impact on small businesses.

Real Estate Development Costs. Proposed regulations have no real estate development costs.

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 36 (06). 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.

Agency's Response to the Department of Planning and Budget's Economic Impact Analysis: The agency concurs with the economic impact analysis prepared by the Department of Planning and Budget regarding the regulations concerning Program of All-Inclusive Care for the Elderly (PACE) as State Plan Service (12VAC30-50-320, 12VAC30-50-330, 12VAC30-50-335, 12VAC30-50-340, 12VAC30-50-345, 12VAC30-50-350, 12VAC30-50-355, 12VAC30-50-360, and 12VAC30-120-61, 12VAC30-120-62, 12VAC30-120-63, 12VAC30-120-64, 12VAC30-120-65, 12VAC30-120-66, 12VAC30-120-67, and 12VAC30-120-68).

Summary

The amendments (i) move the Program of All-Inclusive Care for the Elderly (PACE) regulations from the waiver services section of the Department of Medical Assistance Services' (DMAS') regulations to the State Plan for Medical Assistance Services section, (ii) repeal 12VAC30-120-67 (PACE catastrophic coverage limitation), (iii) make technical changes to the definitions section, and (iv) require that the existing criminal record check process for providers and employees by conducted prior to the beginning of employment.

12VAC30-50-320. Program of All-Inclusive Care for the Elderly (PACE).

The Commonwealth of Virginia has ~~not~~ entered into a valid program agreement or agreements with a PACE provider or providers and the Secretary of the U.S. Department of Health and Human Services.

12VAC30-50-330. PACE definitions.

For purposes of this part and all contracts establishing the Program of All-Inclusive Care for the Elderly (PACE) programs as defined in 42 CFR Part 460, the following definitions shall apply:

"Adult day health care center" or "ADHC" means a DMAS-enrolled provider that offers a community-based day program providing a variety of health, therapeutic, and social services designed to meet the specialized needs of those elderly and disabled individuals at risk of placement in a nursing facility. The ADHC must be licensed by the Virginia Department of Social Services as an adult day care center (ADC) as defined in 22VAC40-60-10.

"Applicant" means an individual seeking enrollment in a PACE plan.

"Capitation rate" means the negotiated Medicaid monthly per capita amount paid to a PACE provider for all services provided to enrollees.

"Catchment area" means the designated service area for a PACE plan.

"Centers for Medicare and Medicaid Services" or "CMS" means the unit of the U.S. Department of Health and Human Services that administers the Medicare and Medicaid programs.

"CFR" means the Code of Federal Regulations.

"DMAS" means the Department of Medical Assistance Services.

"DSS" means the Department of Social Services.

"Direct marketing" means either (i) conducting directly or indirectly door-to-door, telephonic or other "cold call" marketing of services at residences and provider sites; (ii) mailing directly; (iii) paying "finders' fees;" (iv) offering financial incentives, rewards, gifts or special opportunities to eligible individuals or family/caregivers as inducements to use the providers' services; (v) continuous, periodic marketing activities to the same prospective individual or family/caregiver for example, monthly, quarterly, or annual giveaways as inducements to use the providers' services; or (vi) engaging in marketing activities that offer potential customers rebates or discounts in conjunction with the use of the providers' services or other benefits as a means of influencing the individual's or family/caregiver's use of the providers' services.

"Enrollee" means a Medicaid-eligible individual meeting PACE enrollment criteria and receiving services from a PACE plan.

"Full disclosure" means fully informing all PACE enrollees at the time of enrollment that, pursuant to § 32.1-330.3 of the Code of Virginia, PACE plan enrollment can only be guaranteed for a 30-day period.

"Imminent risk of nursing facility placement" means that an individual will require nursing facility care within 30 days if a community-based alternative care program, such as a PACE plan, is not available.

"PACE" means a Program of All-Inclusive Care for the Elderly. PACE services are designed to enhance the quality of life and autonomy for frail, older adults; maximize dignity of, and respect for, older adults; enable frail, older adults to live in the community as long as medically and socially feasible; and preserve and support the older adult's family unit.

"PACE plan" means a comprehensive acute and long-term care prepaid health plan, pursuant to § 32.1-330.3 of the Code of Virginia and as defined in 42 CFR 460.6, operating on a capitated payment basis through which the PACE provider assumes full financial risk. PACE plans operate under both Medicare and Medicaid capitation.

"PACE plan contract" means a contract, pursuant to § 32.1-330.3 of the Code of Virginia, under which an entity assumes full financial risk for operation of a comprehensive acute and long-term care prepaid health plan with capitated payments for services provided to Medicaid enrollees being made by DMAS. The parties to a PACE plan contract are the entities operating the PACE plan, DMAS and CMS.

"PACE plan feasibility study" means a study performed by a research entity approved by DMAS to determine a potential PACE plan provider's ability and resources, or lack thereof, to effectively operate a PACE plan. All study costs are the responsibility of the potential PACE provider.

"PACE protocol" means the protocol for the Program of All-Inclusive Care for the Elderly, as published by On Lok, Inc., as of April 14, 1995, or any successor protocol that may be agreed upon by the federal Secretary of Health and Human Services and On Lok, Inc.

"PACE site" means the location, which includes a primary care center, where the PACE provider both operates the PACE plan's adult day health care center and coordinates the provision of core PACE services, including the provision of primary care.

"PACE provider" means the entity contracting with the Department of Medical Assistance Services to operate a PACE plan.

"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 while receiving services from the provider.

"Preadmission screening" means the process to: (i) evaluate the functional, nursing, and social supports of individuals referred for preadmission screenings; (ii) assist individuals in determining what specific services individuals need; (iii) evaluate whether a service or a combination of existing community-based services are available to meet the individual's needs; (iv) refer individuals to the appropriate provider for Medicaid-funded nursing facility or home and community-based care for those individuals who meet nursing facility level of care.

"Preadmission screening team" means the entity contracted with DMAS that is responsible for performing preadmission screening pursuant to § 32.1-330 of the Code of Virginia.

"Primary care provider" or "PCP" means the individual responsible for the coordination of medical care provided to an enrollee under a PACE plan.

"Provider" means the individual or other entity registered, licensed, or certified, as appropriate, and enrolled by DMAS to render services to Medicaid recipients eligible for services.

"State Plan for Medical Assistance" or "the Plan" means the Commonwealth's legal document approved by CMS identifying the covered groups, covered services and their limitations, and provider reimbursement methodologies as provided for under Title XIX of the Social Security Act.

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

12VAC30-50-335. General PACE plan requirements.

A. DMAS, the state agency responsible for administering Virginia's Medicaid program, shall only enter into PACE plan contracts with approved PACE plan providers. The PACE provider must have an agreement with CMS and DMAS for the operation of a PACE program. The agreement must include:

1. Designation of the program's service area;

2. The program's commitment to meet all applicable federal, state, and local requirements;

3. The effective date and term of the agreement;

4. The description of the organizational structure;

5. Participant bill of rights;

6. Description of grievance and appeals processes;

7. Policies on eligibility, enrollment, and disenrollment;

8. Description of services available;

9. Description of quality management and performance improvement program;

10. A statement of levels of performance required on standard quality measures;

11. CMS and DMAS data requirements;

12. The Medicaid capitation rate and the methodology used to calculate the Medicare capitation rate;

13. Procedures for program termination; and

14. A statement to hold harmless CMS, the state, and PACE participants if the PACE organization does not pay for services performed by the provider in accordance with the contract.

B. A PACE plan feasibility study shall be performed before DMAS enters into any PACE plan contract. DMAS shall contract only with those entities it determines to have the ability and resources to effectively operate a PACE plan. A feasibility plan shall only be submitted in response to a Request for Applications published by DMAS.

C. PACE plans shall offer a voluntary comprehensive alternative to enrollees who would otherwise be placed in a nursing facility. PACE plan services shall be comprehensive and offered as an alternative to nursing facility admission.

D. All Medicaid-enrolled PACE participants shall continue to meet the nonfinancial and financial Medicaid eligibility criteria established by federal law and these regulations. This requirement shall not apply to Medicare only or private pay PACE participants.

E. Each PACE provider shall operate a PACE site that is in continuous compliance with all state licensure requirements for that site.

F. Each PACE provider shall offer core PACE services as described in 12VAC30-50-345 B through a coordination site that is licensed as an ADHC by DSS.

G. Each PACE provider shall ensure that services are provided by health care providers and institutions that are in continuous compliance with state licensure and certification requirements.

H. Each PACE plan shall meet the requirements of §§ 32.1-330.2 and 32.1-330.3 of the Code of Virginia and 42 CFR Part 460.

I. All PACE providers must meet the general requirements and conditions for participation pursuant to the required contracts by DMAS and CMS. All providers must sign the appropriate participation agreement. All providers must adhere to the conditions of participation outlined in the participation agreement and application to provide PACE services, DMAS regulations, policies and procedures, and CMS requirements pursuant to 42 CFR Part 460.

J. Requests for participation as a PACE provider will be screened by DMAS to determine whether the provider applicant meets these basic requirements for participation and demonstrates the abilities to perform, at a minimum, the following activities:

1. Immediately notify DMAS, in writing, of any change in the information that the provider previously submitted to DMAS.

2. Assure freedom of choice to individuals in seeking services 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 are performed.

3. Assure the individual's freedom to refuse medical care, treatment, and services.

4. Accept referrals for services only when qualified staff is available to initiate and perform such services on an ongoing basis.

5. Provide services and supplies to individuals in full compliance with Title VI of the Civil Rights Act of 1964, as amended (42 USC § 2000 et seq.), which prohibits discrimination on the grounds of race, color, religion, sexual orientation or national origin; the Virginians with Disabilities Act (§ 51.5-1 et seq. of the Code of Virginia); § 504 of the Rehabilitation Act of 1973, as amended (29 USC § 794), which prohibits discrimination on the basis of a disability; and the Americans with Disabilities Act of 1990, as amended (42 USC § 12101 et seq.), which provides comprehensive civil rights protections to individuals with disabilities in the areas of employment, public accommodations, state and local government services, and telecommunications.

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

7. Use only DMAS-designated forms for service documentation. The provider must not alter the DMAS forms in any manner unless approval from DMAS is obtained prior to using the altered forms.

8. Not perform any type of direct marketing activities to Medicaid individuals.

9. Maintain and retain business and professional records sufficient to document fully and accurately the nature, scope, and details of the services provided.

a. In general, such records shall be retained for at least six years from the last date of service or as provided by applicable federal and state laws, whichever period is longer. However, 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 six years after such minor has reached the age of 18 years. However, records for Medicare Part D shall be maintained for 10 years in accordance with 42 CFR 423.505(d).

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

10. Furnish information on request and in the form requested to DMAS, the Attorney General of Virginia or his authorized representatives, federal personnel, and the state Medicaid Fraud Control Unit. The Commonwealth's right of access to provider agencies and records shall survive any termination of the provider agreement.

11. 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 individuals of Medicaid.

12. Pursuant to 42 CFR 431.300 et seq., 12VAC30-20-90, and any other applicable federal or state law, all providers shall hold confidential and use for authorized DMAS purposes only all medical assistance information regarding individuals served. A provider shall disclose information in his possession only when the information is used in conjunction with a claim for health benefits, or the data are necessary for the functioning of DMAS in conjunction with the cited laws.

13. CMS and DMAS shall be notified in writing of any change in the organizational structure of a PACE provider organization at least 14 calendar days before the change takes effect.

14. 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 participation agreements and in the applicable DMAS provider manual. DMAS shall conduct ongoing monitoring of compliance with provider participation standards and DMAS policies. A provider's noncompliance with DMAS policies and procedures may result in a retraction of Medicaid payment or termination of the provider agreement, or both.

15. Minimum qualifications of staff.

a. All employees must have a satisfactory work record as evidenced by references from prior job experience, including no evidence of abuse, neglect, or exploitation of vulnerable adults and children. Prior to the beginning of employment, a criminal record check shall be conducted for the provider and each employee and made available for review by DMAS staff. Providers are responsible for complying with the Code of Virginia and state regulations regarding criminal record checks and barrier crimes as they pertain to the licensure and program requirements of their employees' particular practice areas.

b. Staff must meet any certifications, licensure, registration, etc., as required by applicable federal and state law. Staff qualifications must be documented and maintained for review by DMAS or its authorized contractors.

16. At the time of their admission to services, all providers participating in the Medicare and Medicaid programs must provide adult individuals with written information regarding each individual's right to make medical care decisions, including the right to accept or refuse medical treatment and the right to formulate advance directives.

K. Provider's conviction of a felony. The Medicaid provider agreement shall terminate upon conviction of the provider of a felony pursuant to § 32.1-325 of the Code of Virginia. A provider convicted of a felony in Virginia or in any other of the 50 states, the District of Columbia, or the U.S. territories must, within 30 days, notify the Virginia Medicaid Program of this conviction and relinquish the provider agreement. In addition, termination of a provider participation agreement will occur as may be required for federal financial participation.

L. Ongoing quality management review. DMAS shall be responsible for assuring continued adherence to provider participation standards. DMAS shall conduct ongoing monitoring of compliance with provider participation standards and DMAS policies and periodically recertify each provider for participation agreement renewal with DMAS to provide PACE services.

M. Reporting suspected abuse or neglect. Pursuant to §§ 63.2-1508 through 63.2-1513 and 63.2-1606 of the Code of Virginia, if a participating provider entity suspects that a child or vulnerable adult is being abused, neglected, or exploited, the party having knowledge or suspicion of the abuse, neglect, or exploitation shall report this immediately to DSS and to DMAS. In addition, as mandated reporters for vulnerable adults, participating providers must inform their staff that they are mandated reporters and provide education regarding how to report suspected adult abuse, neglect, or exploitation pursuant to § 63.2-1606 F of the Code of Virginia.

N. Documentation requirements. The provider must maintain all records of each individual receiving services. All documentation in the individual's record must be completely signed and dated with name of the person providing the service, title, and complete date with month, day, and year. This documentation shall contain, up to and including the last date of service, all of the following:

1. The most recently updated Virginia Uniform Assessment Instrument (UAI), all other assessments and reassessments, plans of care, supporting documentation, and documentation of any inpatient hospital admissions;

2. All correspondence and related communication with the individual and, as appropriate, consultants, providers, DMAS, DSS, or other related parties; and

3. Documentation of the date services were rendered and the amount and type of services rendered.

12VAC30-50-340. Criteria for PACE enrollment.

A. Eligibility shall be determined in the manner provided for in the State Plan and these regulations. To the extent these regulations differ from other provisions of the State Plan for purposes of PACE eligibility and enrollment, these regulations shall control.

B. Individuals meeting the following nonfinancial criteria shall be eligible to enroll in PACE plans approved by DMAS:

1. Individuals who are age 55 or older;

2. Individuals who require nursing facility level of care and are at imminent risk of nursing facility placement as determined by a nursing home preadmission screening team through a nursing home preadmission screening performed using the UAI;

3. Individuals for whom PACE plan services are medically appropriate and necessary because without the services the individual is at imminent risk of nursing facility placement;

4. Individuals who reside in a PACE plan catchment area;

5. Individuals who meet other criteria specified in a PACE plan contract;

6. Individuals who participate in the Medicaid or Medicare programs as specified in § 32.1-330.3 E of the Code of Virginia; and

7. Individuals who voluntarily enroll in a PACE plan and agree to the terms and conditions of enrollment.

C. To the extent permitted by federal law and regulation, individuals meeting the following financial criteria shall be eligible to enroll in PACE plans approved by DMAS:

1. Individuals whose income is determined by DMAS under the provision of the State Plan to be equal to or less than 300% of the current Supplemental Security Income payment standard for one person; and

2. Individuals whose resources are determined by DMAS under the provisions of the State Plan to be equal to or less than the current resource allowance established in the State Plan.

D. For purposes of a financial eligibility determination, applicants shall be considered as if they are institutionalized for the purpose of applying institutional deeming rules.

E. DMAS shall not pay for services provided to an applicant by a PACE contractor if such services are provided prior to the PACE plan authorization date set by the nursing home preadmission screening team.

12VAC30-50-345. PACE enrollee rights.

A. PACE providers shall ensure that enrollees are fully informed of their rights and responsibilities in accordance with all state and federal requirements. These rights and responsibilities shall include, but not be limited to:

1. The right to be fully informed at the time of enrollment that PACE plan enrollment can only be guaranteed for a 30-day period pursuant to § 32.1-330.3 F of the Code of Virginia;

2. The right to receive PACE plan services directly from the provider or under arrangements made by the provider; and

3. The right to be fully informed in writing of any action to be taken affecting the receipt of PACE plan services.

B. PACE providers shall notify enrollees of the full scope of services available under a PACE plan, as described in 42 CFR 460.92. The services shall include, but not be limited to:

1. Medical services, including the services of a PCP and other specialists;

2. Transportation services;

3. Outpatient rehabilitation services, including physical, occupational and speech therapy services;

4. Hospital (acute care) services;

5. Nursing facility (long-term care) services;

6. Prescription drugs;

7. Home health services;

8. Laboratory services;

9. Radiology services;

10. Ambulatory surgery services;

11. Respite care services;

12. Personal care services;

13. Dental services;

14. Adult day health care services, to include social work services;

15. Interdisciplinary case management services;

16. Outpatient mental health and mental retardation services;

17. Outpatient psychological services;

18. Prosthetics; and

19. Durable medical equipment and other medical supplies.

C. Services available under a PACE plan shall not include any of the following:

1. Any service not authorized by the interdisciplinary team unless such service is an emergency service (i.e., a service provided in the event of a situation of a serious or urgent nature that endangers the health, safety, or welfare of an individual and demands immediate action);

2. In an inpatient facility, private room and private duty nursing services unless medically necessary, and nonmedical items for personal convenience such as telephones charges and radio or television rental, unless specifically authorized by the interdisciplinary team as part of the participant's plan of care;

3. Cosmetic surgery except as described in agency guidance documents;

4. Any experimental medical, surgical or other health procedure; and

5. Any other service excluded under 42 CFR 460.96.

D. PACE providers shall ensure that PACE plan services are at least as accessible to enrollees as they are to other Medicaid-eligible individuals residing in the applicable catchment area.

E. PACE providers shall provide enrollees with access to services authorized by the interdisciplinary team 24 hours per day every day of the year.

F. PACE providers shall provide enrollees with all information necessary to facilitate easy access to services.

G. PACE providers shall provide enrollees with identification documents approved by DMAS. PACE plan identification documents shall give notice to others of enrollees' coverage under PACE plans.

H. PACE providers shall clearly and fully inform enrollees of their right to disenroll at will upon giving 30 days' notice.

I. PACE providers shall make available to enrollees a mechanism whereby disputes relating to enrollment and services can be considered. This mechanism shall be one that is approved by DMAS.

J. PACE providers shall fully inform enrollees of the individual provider's policies regarding accessing care generally and, in particular, accessing urgent or emergency care both within and without the catchment area.

K. PACE providers shall maintain the confidentiality of enrollees and the services provided to them.

12VAC30-50-350. PACE enrollee responsibilities.

A. Enrollees shall access services through an assigned PCP. Enrollees shall be given the opportunity to choose a PCP affiliated with the applicable PACE provider. In the event an enrollee fails to choose a PCP, one shall be assigned by the provider.

B. Enrollees shall be responsible for copayments, if any.

C. Enrollees shall raise complaints relating to PACE plan coverage and services directly with the PACE provider. The provider shall have a DMAS-approved enrollee complaint process in place at all times.

D. Enrollees shall raise complaints pertaining to Medicaid eligibility and PACE plan eligibility directly to DMAS. These complaints shall be considered under DMAS' Client Appeals regulations (12VAC30-110).

E. The PACE provider shall have a grievance process in place including procedures for filing an enrollee's grievance, documenting the grievance, responding to and resolving the grievance in a timely manner, and maintaining confidentiality of the agreement pursuant to 42 CFR 460.120.

12VAC30-50-355. PACE plan contract requirements and standards.

A. Pursuant to 42 CFR Part 460 and § 32.1-330.3 of the Code of Virginia, DMAS shall establish contract requirements and standards for PACE providers.

B. At the point of PACE plan contract agreement, DMAS shall modify 12VAC30-50-320 accordingly and submit it to CMS.

C. Any expansion of PACE programs shall be on a schedule and within an area determined solely at the discretion of DMAS through a Request for Applications (RFA) process. No organization shall begin any new PACE program without going through the RFA process as required by DMAS.

12VAC30-50-360. PACE sanctions.

A. DMAS shall apply sanctions to providers for violations of PACE contract provisions or federal or state law and regulation.

B. Permissible state sanctions shall include, but need not be limited to, the following:

1. A written warning to the provider;

2. Withholding all or part of the PACE provider's capitation payments, or retracting all or part of any reimbursement previously paid;

3. Suspension of new enrollment in the PACE plan;

4. Restriction of current enrollment in the PACE plan; and

5. Contract termination.

Part I
~~Program of All-Inclusive Care for the Elderly (PACE)~~ (Repealed.)

12VAC30-120-61. ~~Definitions.~~ (Repealed.)

~~For purposes of this part and all contracts establishing the Program of All-Inclusive Care for the Elderly (PACE) programs, as defined in 42 CFR Part 460, the following definitions shall apply:~~

"Adult day health care center" or "ADHC" means a DMAS-enrolled provider that offers a community-based day program providing a variety of health, therapeutic, and social services designed to meet the specialized needs of those elderly and disabled individuals at risk of placement in a nursing facility. The ADHC must be licensed by the Virginia Department of Social Services as an Adult Day Care Center (ADC) as defined in 22VAC40-60-10.

~~"Applicant" means an individual seeking enrollment in a PACE plan.~~

~~"Capitation rate" means the negotiated Medicaid monthly per capita amount paid to a PACE provider for services provided to enrollees.~~

~~"Catchment area" means the designated service area for a PACE plan.~~

~~"Centers for Medicare and Medicaid Services" or "CMS" means the unit of the U.S. Department of Health and Human Services that administers the Medicare and Medicaid programs.~~

~~"CFR" means the Code of Federal Regulations.~~

~~"DMAS" means the Department of Medical Assistance Services.~~

~~"DSS" means the Department of Social Services.~~

~~"Enrollee" means a Medicaid-eligible individual meeting PACE enrollment criteria and receiving services from a PACE plan.~~

"PACE" means a Program of All-Inclusive Care for the Elderly. PACE services are designed to enhance the quality of life and autonomy for frail, older adults, maximize dignity of, and respect for, older adults, enable frail older adults to live in the community as long as medically and socially feasible, and preserve and support the older adult's family unit.

"PACE plan feasibility study" means a study performed by a research entity approved DMAS to determine a potential PACE plan provider's ability and resources or lack thereof to effectively operate a PACE plan. All study costs are the responsibility of the potential PACE provider.

~~"PACE provider" means the entity contracting with the Department of Medical Assistance Services to operate a PACE plan.~~

~~"Preadmission screening team" means the entity contracted with DMAS that is responsible for performing preadmission screening pursuant to § 32.1-330 of the Code of Virginia.~~

~~"Primary care provider" or "PCP" means the individual responsible for the coordination of medical care provided to an enrollee under a PACE plan.~~

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

12VAC30-120-62. ~~General PACE plan requirements.~~ (Repealed.)

~~1. Designation of the program's service area;~~

~~2. The program's commitment to meet all applicable federal, state, and local requirements;~~

~~3. The effective date and term of the agreement;~~

~~4. The description of the organizational structure;~~

~~5. Participant bill of rights;~~

~~6. Description of grievance and appeals processes;~~

~~7. Policies on eligibility, enrollment, and disenrollment;~~

~~8. Description of services available;~~

~~9. Description of quality management and performance improvement program;~~

~~10. A statement of levels of performance required on standard quality measures;~~

~~11. CMS and DMAS data requirements;~~

~~12. The Medicaid capitation rate and the methodology used to calculate the Medicare capitation rate;~~

~~13. Procedures for program termination; and~~

~~14. A statement to hold harmless CMS, the state, and PACE participants if the PACE organization does not pay for services performed by the provider in accordance with the contract.~~

~~E. Each PACE provider shall operate a PACE site that is in continuous compliance with all state licensure requirements for that site.~~

~~F. Each PACE provider shall offer core PACE services as described in 12VAC30-120-64 B through a coordination site that is licensed as an ADHC by DSS.~~

~~G. Each PACE provider shall ensure that services are provided by health care providers and institutions that are in continuous compliance with state licensure and certification requirements.~~

~~H. Each PACE plan shall meet the requirements of §§ 32.1-330.2 and 32.1-330.3 of the Code of Virginia and 42 CFR, Part 460.~~

~~1. Immediately notify DMAS, in writing, of any change in the information that the provider previously submitted to DMAS.~~

~~3. Assure the individual's freedom to refuse medical care, treatment, and services.~~

~~4. Accept referrals for services only when qualified staff is available to initiate and perform such services on an ongoing basis.~~

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

~~7. Use only DMAS-designated forms for service documentation. The provider must not alter the DMAS forms in any manner unless approval from DMAS is obtained prior to using the altered forms.~~

~~8. Not perform any type of direct marketing activities to Medicaid individuals.~~

~~9. Maintain and retain business and professional records sufficient to document fully and accurately the nature, scope, and details of the services provided.~~

~~13. CMS and DMAS shall be notified in writing of any change in the organizational structure of a PACE provider organization at least 14 calendar days before the change takes effect.~~

~~15. Minimum qualifications of staff.~~

a. All employees must have a satisfactory work record as evidenced by references from prior job experience, including no evidence of abuse, neglect, or exploitation of vulnerable adults and children. A criminal record check shall be conducted for the provider and each employee and made available for review by DMAS staff. Providers are responsible for complying with the Code of Virginia and state regulations regarding criminal record checks and barrier crimes as they pertain to the licensure and program requirements of their employees' particular practice areas.

K. Provider's conviction of a felony. The Medicaid provider agreement shall terminate upon conviction of the provider of a felony pursuant to § 32.1-325 of the Code of Virginia. A provider convicted of a felony in Virginia or in any other of the 50 states, the District of Columbia or, the U.S. territories, must, within 30 days, notify the Virginia Medicaid Program of this conviction and relinquish the provider agreement. In addition, termination of a provider participation agreement will occur as may be required for federal financial participation.

M. Reporting suspected abuse or neglect. Pursuant to §§ 63.2-1606 and 63.2-1508 through 63.2-1513 of the Code of Virginia, if a participating provider entity suspects that a child or vulnerable adult is being abused, neglected, or exploited, the party having knowledge or suspicion of the abuse, neglect, or exploitation shall report this immediately to DSS and to DMAS. In addition, as mandated reporters for vulnerable adults, participating providers must inform their staff that they are mandated reporters and provide education regarding how to report suspected adult abuse, neglect, or exploitation pursuant to § 63.2-1606 F of the Code of Virginia.

~~2. All correspondence and related communication with the individual, and, as appropriate, consultants, providers, DMAS, DSS, or other related parties; and~~

~~3. Documentation of the date services were rendered and the amount and type of services rendered.~~

12VAC30-120-63. ~~Criteria for PACE enrollment.~~ (Repealed.)

~~B. Individuals meeting the following nonfinancial criteria shall be eligible to enroll in PACE plans approved by DMAS:~~

~~1. Individuals who are age 55 or older;~~

2. Individuals who require nursing facility level of care and are at imminent risk of nursing facility placement as determined by a Nursing Home Preadmission Screening Team through a Nursing Home Preadmission Screening performed using the UAI;

~~3. Individuals for whom PACE plan services are medically appropriate and necessary because without the services the individual is at imminent risk of nursing facility placement;~~

~~4. Individuals who reside in a PACE plan catchment area;~~

~~5. Individuals who meet other criteria specified in a PACE plan contract;~~

~~6. Individuals who participate in the Medicaid or Medicare programs as specified in § 32.1-330.3 E of the Code of Virginia; and~~

~~7. Individuals who voluntarily enroll in a PACE plan and agree to the terms and conditions of enrollment.~~

~~C. To the extent permitted by federal law and regulation, individuals meeting the following financial criteria shall be eligible to enroll in PACE plans approved by DMAS:~~

~~2. Individuals whose resources are determined by DMAS under the provisions of the State Plan to be equal to or less than the current resource allowance established in the State Plan.~~

~~D. For purposes of a financial eligibility determination, applicants shall be considered as if they are institutionalized for the purpose of applying institutional deeming rules.~~

E. DMAS shall not pay for services provided to an applicant by a PACE contractor if such services are provided prior to the PACE plan authorization date set by the Nursing Home Preadmission Screening team.

12VAC30-120-64. ~~PACE enrollee rights.~~ (Repealed.)

A. PACE providers contractors shall ensure that enrollees are fully informed of their rights and responsibilities in accordance with all state and federal requirements. These rights and responsibilities shall include, but not be limited to:

~~1. The right to be fully informed at the time of enrollment that PACE plan enrollment can only be guaranteed for a 30-day period pursuant to § 32.1-330.3 F of the Code of Virginia;~~

~~2. The right to receive PACE plan services directly from the provider or under arrangements made by the provider; and~~

~~3. The right to be fully informed in writing of any action to be taken affecting the receipt of PACE plan services.~~

~~B. PACE providers shall notify enrollees of the full scope of services available under a PACE plan, as described in 42 CFR 460.92. The services shall include, but not be limited to:~~

~~1. Medical services, including the services of a PCP and other specialists;~~

~~2. Transportation services;~~

~~3. Outpatient rehabilitation services, including physical, occupational and speech therapy services;~~

~~4. Hospital (acute care) services;~~

~~5. Nursing facility (long-term care) services;~~

~~6. Prescription drugs;~~

~~7. Home health services;~~

~~8. Laboratory services;~~

~~9. Radiology services;~~

~~10. Ambulatory surgery services;~~

~~11. Respite care services;~~

~~12. Personal care services;~~

~~13. Dental services;~~

~~14. Adult day health care services, to include social work services;~~

~~15. Interdisciplinary case management services;~~

~~16. Outpatient mental health and mental retardation services;~~

~~17. Outpatient psychological services;~~

~~18. Prosthetics; and~~

~~19. Durable medical equipment and other medical supplies.~~

~~C. Services available under a PACE plan shall not include any of the following:~~

2. In an inpatient facility, private room and private duty nursing services unless medically necessary, and nonmedical items for personal convenience such as telephones charges and radio or television rental unless specifically authorized by the interdisciplinary team as part of the participant's plan of care;

~~3. Cosmetic surgery except as described in agency guidance documents;~~

~~4. Any experimental medical, surgical or other health procedure; and~~

~~5. Any other service excluded under 42 CFR 460.96.~~

~~D. PACE providers shall ensure that PACE plan services are at least as accessible to enrollees as they are to other Medicaid-eligible individuals residing in the applicable catchment area.~~

~~E. PACE providers shall provide enrollees with access to services authorized by the interdisciplinary team 24 hours per day every day of the year.~~

~~F. PACE providers shall provide enrollees with all information necessary to facilitate easy access to services.~~

~~G. PACE providers shall provide enrollees with identification documents approved by DMAS. PACE plan identification documents shall give notice to others of enrollees' coverage under PACE plans.~~

~~H. PACE providers shall clearly and fully inform enrollees of their right to disenroll at will upon giving 30 days' notice.~~

~~I. PACE providers shall make available to enrollees a mechanism whereby disputes relating to enrollment and services can be considered. This mechanism shall be one that is approved by DMAS.~~

J. PACE providers shall fully inform enrollees of the individual provider's policies regarding accessing care generally, and in particular, accessing urgent or emergency care both within and without the catchment area.

~~K. PACE providers shall maintain the confidentiality of enrollees and the services provided to them.~~

12VAC30-120-65. ~~PACE enrollee responsibilities.~~ (Repealed.)

~~B. Enrollees shall be responsible for co-payments, if any.~~

12VAC30-120-66. ~~PACE plan contract requirements and standards.~~ (Repealed.)

~~A. Pursuant to 42 CFR Part 460 and § 32.1-330.3 of the Code of Virginia, DMAS shall establish contract requirements and standards for PACE providers.~~

~~B. At the point of PACE plan contract agreement, DMAS shall modify 12VAC30-50-320 accordingly and submit it to CMS.~~

12VAC30-120-67. ~~PACE catastrophic coverage limitation.~~ (Repealed.)

~~A. DMAS shall limit contractors' liability for Medicaid covered services required by individual enrollees when the need for services arises from a catastrophic occurrence or disease.~~

B. If, during a single state fiscal year period (July 1 through June 30), an enrollee receives medically necessary PACE plan services necessitated by a catastrophic occurrence or disease and the cost of those services, calculated using DMAS' applicable provider payment schedules, exceeds the catastrophic coverage limitation established in the PACE plan contract for the Medicaid capitated portion of the payments, DMAS shall compensate the contractor for Medicaid covered services provided beyond the limitation amount.

~~C. When this provision is invoked, DMAS shall compensate the contractor for Medicaid covered services at the rates established under the applicable Medicaid provider payment schedules.~~

12VAC30-120-68. ~~PACE sanctions.~~ (Repealed.)

~~A. DMAS shall apply sanctions to providers for violations of PACE contract provisions and/or federal or state law and regulation.~~

~~B. Permissible state sanctions shall include, but need not be limited to, the following:~~

~~1. A written warning to the provider;~~

~~2. Withholding all or part of the PACE provider's capitation payments, or retracting all or part of any reimbursement previously paid;~~

~~3. Suspension of new enrollment in the PACE plan;~~

~~4. Restriction of current enrollment in the PACE plan; and~~

~~5. Contract termination.~~

VA.R. Doc. No. R09-1534; Filed December 2, 2008, 3:00 p.m.