10 Colo. Code Regs. § 2505-10-8.497

Current through Register Vol. 47, No. 11, June 10, 2024

Section 10 CCR 2505-10-8.497 - PROGRAMS OF ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE)

8.497.1STATUTORY AUTHORITY AND APPLICABILITY

8.497.1.A. The statutory authority for these rules is set forth in § 25.5-5-412, C.R.S.

8.497.1.B. A PACE organization, as defined herein, must comply with all applicable federal, state, and local statutes, regulations, and laws including but not limited to the following:

1. Code of Federal Regulations (CFR), Title 42 - Public Health, Chapter IV - Centers for Medicare & Medicaid Services, Department of Health and Human Services, Subchapter E Programs of All-Inclusive Care for the Elderly (PACE), Part 460 - Programs of All-Inclusive Care for the Elderly (PACE). This will be referred to in this regulation as 42 CFR 460.

2. Section 25.5-5-412, C.R.S.

8.497.1.C. A PACE organization must have an agreement with the CMS and the Department, as defined herein, for the operation of a PACE program.

8.497.2SCOPE AND PURPOSE

8.497.2.A. The purpose of these rules is to implement § 25.5-5-412, C.R.S. which require the Department to establish, administer, and enforce minimum regulatory standards and rules for the PACE program, including for contracted entities of the PACE program, to ensure the health, safety and welfare of PACE participants.

8.497.2.B. Scope and purpose.

1. General. This regulation sets forth the following:

a. The requirements that an entity must meet to be approved as a PACE organization that operates a PACE program under Medicaid in the State of Colorado;

b. Marketing requirements for PACE organizations;

c. Requirements for ensuring fiscal soundness of PACE organizations;

d. Procedures for sanctions, enforcement actions, and terminations;

e. How individuals may qualify to enroll in a PACE program;

f. Reimbursement for PACE services;

g. Provisions for State monitoring of PACE programs;

h. General PACE organization requirements and PACE services;

i. Requirements to collect data, maintain records and report information, including encounter data; and

j. Requirements for PACE quality improvement monitoring.

2. Program purpose. PACE provides, prepaid, capitated, comprehensive health care services designed to meet the following objectives:

a. Enhance the quality of life and autonomy for older adults who require the level of care provided in a nursing facility;

b. Maximize dignity of, and respect for, older adults;

c. Enable older adults to live in the community as long as medically and socially feasible; and

d. Preserve and support the older adult's family unit.

8.497.3DEFINITIONS

As used in this regulation, unless the context indicates otherwise, the following definitions apply:

A. CMS means Centers for Medicare and Medicaid Services.

B. Dementia diseases and related disabilities means a condition where mental ability declines and is severe enough to interfere with an individual's ability to perform everyday tasks. Dementia diseases and related disabilities include Alzheimer's disease, mixed dementia, Lewy Body Dementia, vascular dementia, frontotemporal dementia, and other types of dementia.

C. Department means the Colorado Department of Health Care Policy and Financing.

D. Designated Representative means a representative who is designated by the participant to act on the participant's behalf.

E. Medicaid participant means an individual determined eligible for Medicaid who is enrolled in a PACE program.

F. PACE means the programs of all-inclusive care for the elderly.

G. PACE center is a facility which includes a primary care clinic, and areas for therapeutic recreation, restorative therapies, socialization, personal care, and dining, and which serves as the focal point for coordination and provision of most PACE services.

H. PACE contract means the contract between the Department and a PACE organization.

I. PACE organization means an entity that has in effect a PACE program agreement to operate a PACE program under this regulation.

J. PACE program means a program of all-inclusive care for the elderly that is operated by an approved PACE organization and that provides comprehensive healthcare services to PACE enrollees in accordance with a PACE program agreement.

K. PACE program agreement means an agreement between a PACE organization, CMS, and the Department.

L. Participant means an individual who is enrolled in a PACE program.

M. Service, as used in this regulation, means all services that could be required under Section 8.497.8.B., including items and drugs.

N. State administering agency means the Department.

O. Survey Agency means either the Colorado Department of Public Health and Environment or any contractor the Department engages to conduct onsite inspections of a PACE center.

P. Subcontractor means a third party contracted with a PACE organization to aid in performance of the PACE contract work.

Q. Telehealth means a mode of delivery of health care services through HIPAA-compliant telecommunications systems, including information, electronic, and communication technologies, remote monitoring technologies and store-and-forward transfers, to facilitate the assessment, diagnosis, consultation, treatment, education, care management, or self-management of a covered person's health care while the covered person is located at an originating site and the provider is located at a distant site.

R. The Act means the Social Security Act.

S. Trial period means the first 3 contract years in which a PACE organization operates under a PACE program agreement, including any contract year during which the entity operated under a PACE demonstration waiver program.

8.497.4PACE ORGANIZATION APPLICATION AND WAIVER PROCESS

8.497.4.A. This section sets forth the application procedures and the process by which a PACE organization may request a waiver of certain regulatory requirements, pursuant to 42 CFR § 460.10.

8.497.4.B. Application requirements.

1. The application requirements for PACE organizations shall be in accordance with 42 CFR § 460.12.

2. Letter of intent. Prior to submission of an application. Any individual authorized to act for an entity seeking to become a PACE organization or a PACE organization that seeks to expand its service area and/or add a PACE center site must notify the Department by submitting a letter of intent in the form and manner specified by the Department at least 90 calendar days before the anticipated application date.

3. Department-specific application requirements. An entity's application to the Department to become a PACE organization or to expand its service area and/or add a PACE center must contain information to demonstrate financial and operational stability. This includes, but is not limited to:

a. Financial assets;

b. Additional owners and/or financially invested organizations;

c. Risk reserve;

d. Reinsurance; and

e. Staff recruitment and retention program.

4. The Department may allow more than one PACE organization per zip code.

8.497.4.C. Department evaluation of applications. The Department evaluates an application in accordance with the requirements of 42 CFR § 460.18 and based on the following information.

1. Information contained in the application;

2. Information obtained by the Department or a Survey Agency through on-site visits or any other means;

3. Department and/or state of Colorado budgetary considerations and constraints; and

4. Financial and operational stability of the applicant.

8.497.4.D. Notice of the Department's determination will be conducted in accordance with 42 CFR § 460.20.

8.497.4.E. Submission and evaluation of waiver requests. A PACE organization, or an entity submitting an application to become a PACE organization, must submit its waiver request in accordance with 42 CFR § 460.26.

8.497.4.F. Notice of the Department's determination on waiver requests will be conducted in accordance with 42 CFR § 460.28.

8.497.5PACE PROGRAM AGREEMENT

8.497.5.A. A PACE program agreement must meet the requirements set forth at 42 CFR § 460.30.

8.497.5.B. Content and terms of PACE program agreement.

1. The PACE program agreement must include:

a. All content required by 42 CFR § 460.32.

b. The criteria used to determine if an individual's health or safety would be jeopardized by living in a community setting at the time of enrollment.

8.497.5.C. The duration of the PACE program agreement shall be in accordance with 42 CFR § 460.34.

8.497.5.D. The PACE organization must comply with all requirements of the PACE program agreement. If the PACE program agreement is amended or modified in any way, the amendment or modification must be automatically incorporated herein as of the effective date of the amendment or modification, and the PACE organization must comply with all requirements of the amendment or modification as of that date.

8.497.6SANCTIONS, ENFORCEMENT ACTIONS, AND TERMINATION

8.497.6.A. Violations for which the Department may impose sanctions.

1. In addition to other remedies authorized by law or contract, the Department may impose any of the sanctions specified in Section 8.497.6.B., if the Department or a Survey Agency determines that a PACE organization commits any of the violations specified in 42 CFR § 460.40(a) or the following violations:

a. Makes payment to or employs or contracts with any individual or organization that has a criminal conviction as defined in 42 § CFR 460.68(a); or

b. Makes payment to individuals and entities excluded by the Office of Inspector General or included on the preclusion list as pursuant to 42 § CFR 460.86.

2. If the Department or a Survey Agency makes a determination that could lead to termination of a PACE program agreement under Section 8.497.6.C., the Department may impose any of the sanctions specified in Section 8.497.6.B. If the Department determines that the circumstances in Section 8.497.6.C.2.a. exist, the Department does not have to determine that the circumstances in Section 8.497.6.C.2.b. exist prior to imposing an enrollment and/or payment suspension.

8.497.6.B. Suspension of enrollment or payment by the Department.

1. Enrollment Suspension. If a PACE organization commits one or more violations specified in 42 CFR § 460.40(a), the Department may suspend enrollments or place a limit on enrollments after the date the Department notifies the organization of the violation.

2. Payment Suspension. If a PACE organization commits one or more violations specified in 42 CFR § 460.40(a), for participants enrolled after the date the Department notifies the PACE organization of the violation, the Department may suspend Medicaid payment to the PACE organization.

3. Term of suspension. A suspension or denial of payment remains in effect until the Department is satisfied that the following conditions are met:

a. The PACE organization has corrected the cause of the violation; and

b. The violation is not likely to recur.

4. Restrictions and Conditions. The Department may impose restrictions or conditions on a PACE organization, which may include at least one of the following:

a. Retaining a consultant to monitor the effectiveness of corrective measures for a specific period determined by the Department;

b. Monitoring the effectiveness of corrective measures by the Department for a specific period; or

c. Requiring additional training for personnel, owners, or operators of the PACE organization.

5. Notification and Plan Requirements.

a. If the Department imposes any restriction or condition that is not the result of a serious and immediate threat to the health, safety, or welfare of a PACE participant, the Department shall notify the PACE organization of the restriction or condition in writing.

b. If the Department imposes any restriction or condition that is the result of a serious and immediate threat to the health, safety, or welfare of a PACE participant, the Department shall notify the PACE organization of the restriction or condition in writing, by telephone, or in person during an on-site visit.

i. The PACE organization must remedy the circumstances creating the harm or likelihood of harm immediately upon receiving notice of the restriction or condition.

c. If the Department provides notice of a restriction or condition by telephone or in person, the Department shall send written confirmation of the restriction or condition to the PACE organization.

d. A PACE organization must complete corrective action as specified in Section 8.497.13.C.1.

8.497.6.C. Termination of a PACE program agreement. The Department may terminate a PACE program agreement for cause, pursuant to 42 CFR § 460.50.

8.497.6.D. Transitional care during termination. The PACE organization must meet the transitional care requirements set forth in 42 CFR § 460.52.

8.497.6.E. Termination procedures.

1. Except as provided in Section 8.497.6.E.2., if the Department terminates a PACE program agreement with a PACE organization, it will furnish the PACE organization with a reasonable opportunity to develop and implement a corrective action plan to correct the deficiencies that were the basis of the Department's determination that cause exists for termination:

2. The Department may terminate a PACE program agreement and PACE contact without invoking the procedures in Section 8.497.6.E.1. if the Department determines that a delay in termination, resulting from compliance with these procedures before termination, would pose an imminent and serious risk to the health of participants enrolled with the organization..

8.497.7PACE ADMINISTRATIVE REQUIREMENTS

8.497.7.A. PACE organizational structure. The PACE organizational structure must comply with the requirements set forth in 42 CFR § 460.60.

8.497.7.B. Governing body. The governing body of the PACE organization must comply with the requirements set forth in 42 CFR § 460.62

8.497.7.C. Compliance oversight requirements. The PACE organization must adopt and implement compliance oversight requirements in accordance with 42 CFR § 460.63.

8.497.7.D. Personnel qualifications for staff with direct participant contact. The PACE organization must comply with the personnel qualifications set forth in 42 CFR § 460.64.

8.497.7.E. Training.

1. The PACE organization must provide training to maintain and improve the skills and knowledge of each staff member with respect to the individual's specific duties that results in their continued ability to demonstrate the skills necessary for the performance of the position.

2. In addition to the general qualification requirements specified in 42 CFR § 460.66, all PACE organization personnel having direct participant contact must complete the following trainings annually. Newly hired personnel must complete the training before working independently:

a. Mandatory reporting of adult mistreatment. Staff members must complete training that includes reporting requirements as specified in C.R.S. § 18-6.5-108;

b. The service determination process as specified in Section 8.497.9.G; and c. Dementia diseases and related disabilities. The training must be culturally competent and include at least the following content:

i. Dementia disease and related disabilities.

ii. Person-centered care.

iii. Care planning.

iv. Activities of daily living.

v. Dementia-related behaviors and communication.

3. All orientation, training, competency, and personnel action documentation must be retained in the personnel files.

8.497.7.F. Program integrity. The PACE organization must comply with the program integrity requirements set forth in 42 CFR § 460.68.

8.497.7.G. Contracted services. The PACE organization must comply with the contracted service requirements set forth in 42 CFR § 460.70.

8.497.7.H. Oversight of direct participant care. The PACE organization must oversee direct participant care in accordance with the requirements set forth in 42 CFR § 460.71.

8.497.7.I. Physical environment. The PACE center must meet the physical environment requirements set forth in 42 CFR § 460.72.

8.497.7.J. Infection control. The PACE organization must comply with the infection control requirements set forth in 42 CFR § 460.74.

8.497.7.K Transportation services.

1. Safety, accessibility, and equipment. A PACE organization's transportation services must be safe, in good working order, accessible, and equipped to meet the needs of the participant population and meet the transportation services requirements set forth in 42 CFR § 460.76.

2. Maintenance of vehicles.

a. If the PACE organization owns, rents, or leases transportation vehicles, it must maintain these vehicles in accordance with the manufacturer's recommendations.

b. If a contractor provides transportation services, the PACE organization must ensure that the vehicles are maintained in accordance with the manufacturer's recommendations.

c. Safety inspections must include the inspection of items as described in Rules Regulating Transportation by Motor Vehicle, 4 CCR 723-6; § 6103 and § 6104.

3. Drivers.

a. PACE organizations must ensure that each driver meets the following requirements:

i. Drivers must be 18 years of age or older;

ii. Have at least one year of driving experience;

iii. Possess a valid Colorado driver's license.

iv. Provide a copy of their current Colorado motor driving vehicle record, with the previous seven years of driving history; and

v. Complete a Colorado or National-based criminal history record check.

b. Drivers must be disqualified from serving as drivers for any program participants for any of the following reasons:

i. A conviction of substance abuse occurring within the seven (7) years preceding the date the criminal history record check is completed;

ii. A conviction in Colorado, at any time, of any Class 1 or 2 felony under Title 18, C.R.S.;

iii. A conviction in Colorado, within seven (7) years preceding the date the criminal history record check is completed, of a crime of violence, as defined in C.R.S. § 18-1.3-406(2);

iv. A conviction in Colorado, within four (4) years preceding the date the criminal history record check is completed, of any Class 4 felony under Title 18, Articles 2, 3, 3.5, 4, 5, 6, 6.5, 8, 9, 12, or 15, C.R.S.;

v. A conviction of an offense in any other state that is comparable to any offense listed in subparagraphs (f)(II)(A) through (D) within the same time periods as listed in subparagraphs (f)(II)(A) through (D) of Rules Regulating Transportation by Motor Vehicle, 4 C.C.R. 723-6; § 6114;

vi. A conviction in Colorado, at any time, of a felony or misdemeanor unlawful sexual offense against a child, as defined in § 18-3-411, C.R.S., or of a comparable offense in any other state or in the United States at any time;

vii. A conviction in Colorado within two (2) years preceding the date the criminal history record check is completed of driving under the influence, as described in § 42-4-1301(1)(f), C.R.S. or driving with excessive alcoholic content, as described in § 42-4-1301(1)(g), C.R.S;

viii. A conviction within two (2) years preceding the date the criminal history record check is completed of an offense comparable to those included in subparagraph (f)(III)(B), 4 C.C.R. 723-6; § 6114 in any other state in the United States; and

ix. For purposes of 4 C.C.R. 723-6; § 6114(f)(IV), a deferred judgment and sentence pursuant to § 18-1.3-102, C.R.S., shall be deemed to be a conviction during the period of the deferred judgment and sentence.

8.497.7.L. Dietary services. The PACE organization must comply with the dietary services requirements set forth in 42 CFR § 460.78.

8.497.7.M. Fiscal Soundness. The PACE organization must comply with the fiscal soundness requirements set forth in 42 CFR § 460.80.

8.497.7.N. Marketing.

1. The PACE organization must comply with the marketing requirements set forth in 42 CFR § 460.82.

2. Marketing information must be free of material inaccuracies, misleading information, or misrepresentations on all platforms.

3. The Department retains the right to disapprove previously approved marketing materials if they are subsequently found to be inaccurate, altered, or otherwise non-compliant.

8.497.7.O. Emergency preparedness. The PACE organization must comply with all applicable federal, state, and local emergency preparedness requirements and must establish and maintain an emergency preparedness program that meets the requirements set forth in 42 CFR § 460.84.

8.497.8PACE SERVICES

8.497.8.A. Pursuant to 42 CFR § 460.90, if an eligible Medicaid participant elects to enroll in a PACE program:

1. Medicare and Medicaid benefit limitations and conditions relating to amount, duration, scope of services, deductibles, copayments, coinsurance, or other cost-sharing do not apply.

2. The participant, while enrolled in a PACE program, must receive Medicare and Medicaid benefits solely through the PACE organization.

8.497.8.B. Required services. The PACE organization must comply with the requirements set forth in 42 CFR § 460.92.

8.497.8.C. Excluded services. The services set forth in 42 CFR § 460.96 are excluded from coverage under PACE.

8.497.8.D. Service delivery.

1. Access to services. The PACE organization is responsible for providing care that meets the needs of each participant across all care settings, 24 hours a day, every day of the year, and must establish and implement a written plan to ensure that care is appropriately furnished.

2. Provision of services.

a. The PACE organization must provide services in accordance with 42 CFR § 460.98(b).

b. The PACE organization must visit each participant in-person or via telehealth across all care settings as often as the participant's condition requires, but no less than once each calendar month.

i. If a participant does not receive a visit during a calendar month, the PACE organization must notify the Department, in writing, within 15 calendar days of the following calendar month. The notice must explain the reason(s) why the participant did not receive a visit.

ii. For the purposes of this requirement, a visit must be provided directly by PACE staff or a contracted specialist. The delivery of items or medications and services routinely provided by a contracted residential care provider are not considered a visit.

iii. If the PACE organization provides these visits via telehealth, the PACE organization must ensure the telehealth delivery option meets the following requirements:

1) Participants must have an informed choice between in-person and telehealth services;

2) The use of the telehealth delivery option will not prohibit or discourage the use of in-person services;

3) Telehealth will not be used for the provider's convenience; and

4) Telehealth must be provided using technology compliant with Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Security and Breach Notification Rules.

iv. The telehealth permissions in this section do not apply to the in-person assessment and reassessment requirements as described in 8.497.8.G.

3. Minimum services furnished at each PACE center. At a minimum, the PACE organization must provide the services set forth in 42 CFR § 460.98(c) at each PACE center.

4. PACE center operation. The PACE organization must operate its center(s) in accordance with 42 CFR § 460.98(d).

a. Services at the PACE center must be provided consistent with any applicable standards of practice for that service, and, when applicable, by staff with the requisite qualifications to perform the service.

5. Center attendance. The frequency of a participant's attendance at a center is determined by the interdisciplinary team, based on the needs and preferences of each participant.

8.497.8.E. Emergency care. The PACE organization must comply with the emergency care requirements set forth in 42 CFR § 460.10 0.

8.497.8.F. Interdisciplinary team. The PACE organization must comply with the interdisciplinary team requirements set forth in 42 CFR § 460.102.

8.497.8.G. Participant assessment.

1. The PACE organization must comply with the assessment and plan of care requirements set forth in 42 CFR § 460.104.

2. Unscheduled reassessments. In addition to the requirements set forth in 42 CFR § 460.104(d), as it relates to a participant being discharged from a hospital, the appropriate members of the interdisciplinary team, as identified by the interdisciplinary team, must conduct an in-person assessment within 72 hours of a participant's hospital discharge for a participant who was admitted for 24 hours or more.

8.497.8.H. Plan of care.

1. The PACE organization must comply with the plan of care requirements set forth in 42 CFR § 460.106.

2. Residential care provider involvement in plan of care. For participants receiving residential care, the PACE organization must include residential care providers in the evaluation of the plan of care and share the plan of care with residential care providers.

8.497.9PARTICIPANT RIGHTS

8.497.9.A. Bill of rights. The PACE organization must comply with the requirements set forth in 42 CFR § 460.110.

8.497.9.B. Specific rights to which a participant is entitled. The PACE organization must comply with the requirements set forth in 42 CFR § 460.112.

1. Information disclosure. In addition to the requirements set forth in 42 CFR § 460.112(b), the participant has the following rights:

a. To receive a list of the employees of the PACE organization who furnish direct care to the participant upon enrollment and upon request. At a minimum, the list must include each discipline of the interdisciplinary team as set forth in 42 CFR § 460.102(b).

b. To have an equal opportunity to receive meaningful communication and to participate fully in discussions involving the PACE program, services, activities, eligibility, enrollment and other benefit information, in the language preferred by the participant.

8.497.9.C. Restraints. The PACE organization must comply with the requirements set forth in 42 CFR § 460.114.

8.497.9.D. Explanation of rights. The PACE organization must comply with the requirements set forth in 42 CFR § 460.116 and must display the contact information for the Colorado PACE Ombudsman in a prominent place in the PACE center.

8.497.9.E. Violation of rights. The PACE organization must have established documented procedures to respond to and rectify a violation of a participant's rights.

8.497.9.F. Grievance process. The PACE organization must comply with the requirements set forth in 42 CFR § 460.12 0.

8.497.9.G. Service determination process.

1. The PACE organization must comply with the requirements set forth in 42 CFR § 460.121.

2. PACE organization decisions to reduce or terminate services. If the PACE organization terminates or reduces a service, without the participant requesting the termination or reduction, the PACE organization must provide written notice to the participant of the right to file a service determination request to continue the service.

8.497.9.H. PACE organization's appeals process.

1. The PACE organization must comply with the requirements set forth in 42 CFR § 460.122.

2. A PACE participant must exhaust the internal appeals process described in this part prior to requesting a State Fair Hearing as described in Section 8.497.9.I. and 10 CCR 2505-10 8.057.

8.497.9.I. Additional Appeal Rights Under Medicare or Medicaid.

1. A PACE organization must comply with the requirements set forth in 42 CFR § 460.124.

2. Medicaid participants have the right to a state fair hearing under Section 8.057. Appeals must be filed within 60 calendar days of the date of the notice of adverse action.

8.497.10QUALITY IMPROVEMENT

8.497.10.A. Quality improvement program and plan. A PACE organization must establish, implement, maintain, and evaluate an effective data-driven quality improvement program and plan, pursuant to 42 CFR § 460.130 and 460.132, that contains all requirements set forth in 42 CFR § 460.134.

8.497.10.B. Internal quality improvement activities. A PACE organization must comply with the requirements set forth in 42 CFR § 460.136.

8.497.10.C. Committees with community input. A PACE organization must comply with the requirements set forth in 42 CFR § 460.138.

1. Minimum program requirements. A PACE organization's quality improvement program must include, but is not limited to, the use of objective measures to demonstrate improved performance with regard to the following:

8.497.11PARTICIPANT ENROLLMENT AND DISENROLLMENT

8.497.11.A. Eligibility to enroll in a PACE program. A PACE organization must comply with the requirements set forth in 42 CFR § 460.150.

8.497.11.B. Enrollment process.

1. A PACE organization must comply with the requirements set forth in 42 CFR § 460.152.

2. Additional intake process requirements.

a. At least one member of an interdisciplinary team must assess the individual in the individual's place of residence prior to enrollment. This assessment must be completed by a Registered Nurse, Physical Therapist, Occupational Therapist, Home Care Coordinator, or appropriate members of an interdisciplinary team as appointed by an interdisciplinary team.

b. The appropriate members of an interdisciplinary team, as identified by an interdisciplinary team, must review and discuss each potential participant and decide to approve or deny the individual's enrollment based on that review.

8.497.11.C. Enrollment agreement. If the potential participant meets the eligibility requirements and wants to enroll, he or she must sign an enrollment agreement which contains, at a minimum, the information required by 42 CFR § 460.154.

8.497.11.D. Other enrollment procedures. The PACE organization must comply with the requirements set forth in 42 CFR § 460.156.

8.497.11.E. Effective date of enrollment. A participant's enrollment in the program is effective on the first day of the calendar month following the date the PACE organization receives the signed enrollment agreement.

8.497.11.F. Continuation of enrollment.

1. The PACE organization must comply with the requirements set forth in 42 CFR § 460.160.

2. In addition to the waiver of annual requirement regulations set forth in 42 CFR § 460.160(b)(1), a participant who continues to meet nursing facility level of care during their first annual recertification, is permanently waived from the annual recertification requirement.

3. In addition to the deemed continued eligibility regulations set forth in 42 CFR § 460.160(b)(2), the following apply:

a. If the PACE organization believes the participant would be expected to meet the nursing facility level of care within the next 6 months, the organization must submit a request for deemed continued eligibility in the form and manner specified by the Department.

b. The Department will notify the PACE organization of the Department's decision in writing within 15 calendar days upon receipt of all requested information.

c. If the Department determines the participant does not qualify for deemed continuous eligibility, the PACE organization must follow involuntary disenrollment procedures as described in Section 8.497.11.H., unless the participant chooses to voluntarily disenroll.

8.497.11.G. Voluntary disenrollment. The PACE organization must comply with the voluntary disenrollment requirements set forth in 42 CFR § 460.162.

8.497.11.H. Involuntary disenrollment.

1. The PACE organization must comply with the involuntary disenrollment requirements set forth in 42 CFR § 460.164.

2. In addition to the reasons for involuntary disenrollment regulations set forth in 42 CFR § 460.164(b), the following applies for involuntary disenrollment:

a. As it relates to 42 CFR § 460.164(b)(1) and 460.164(b)(2), the PACE organization must provide written notice to the participant, designated representative, or both explaining the amount due.

b. A participant may be involuntarily disenrolled if the participant engages in noncompliant behavior, as described in 42 CFR § 460.164(e).

3. Involuntary disenrollment request requirements.

a. A PACE organization must submit an involuntary disenrollment request to the Department in a timely manner and in the form and manner specified by the Department.

b. Before an involuntary disenrollment is effective, the Department must review it and determine in a timely manner that the PACE organization has adequately documented acceptable grounds for disenrollment.

8.497.11.I. Disenrollment responsibilities. The PACE organization must comply with the disenrollment responsibilities requirements set forth in 42 CFR § 460.166.

8.497.11.J. Reinstatement in Medicaid programs. The PACE organization must comply with the reinstatement in other Medicaid program requirements set forth in 42 CFR § 460.168.

8.497.11.K. Reinstatement in PACE. The PACE organization must comply with the reinstatement in PACE requirements set forth in 42 CFR § 460.170.

8.497.11.L. Documentation of disenrollment. The PACE organization must comply with the documentation of disenrollment requirements set forth in 42 CFR § 460.172.

8.497.12PAYMENT

8.497.12.A. Medicaid payment.

1. The PACE organization shall receive Medicaid payments in accordance with 42 CFR § 460.182.

2. The Department may also recover, at the Department's discretion, payments made to the PACE organization in error for any reason, including, but not limited to, overpayments, improper payments, and excess funds received by the PACE organization by deduction from subsequent payments as specified in the PACE contract, deduction from any payment due under any other contracts, grants or agreements between Colorado and the PACE organization, or by any other appropriate method for collecting debts owed to the Department.

3. Payment Reconciliations. A PACE organization must adhere to the terms related to the participant-specific amount reconciliation, participant-specific reconciliation payments, and annual reconciliation as specified in the PACE contract.

8.497.12.B. Post-eligibility treatment of income.

1. The Department may provide for post-eligibility treatment of income for PACE participants as set forth in Sections 8.482.33 and 8.485.80.

2. Post-eligibility treatment of income is applied, as specified in 42 CFR § 460.184(b).

8.497.12.C. PACE premiums. The PACE organization must comply with the PACE premiums requirements set forth in 42 CFR § 460.186.

8.497.13STATE MONITORING

8.497.13.A. Monitoring during trial period. During the trial period, the Department conducts comprehensive annual reviews of the operation of a PACE organization, in accordance with the requirements and scope set forth in 42 CFR § 460.190.

8.497.13.B. Ongoing monitoring after trial period. At the conclusion of the trial period, the Department continues to conduct review of a PACE organization, as appropriate, in accordance with the requirements set forth in 42 CFR § 460.192.

8.497.13.C. Corrective action. The PACE organization must comply with the requirements set forth in 42 CFR § 460.194. In addition, as it relates to a corrective action plan, a PACE organization must:

1. Submit an acceptable corrective action plan in the form, manner and timeframe specified by the Department, when corrective action is deemed necessary by the Department. An acceptable plan must include but is not limited to:

a. The corrective action the PACE organization will take on behalf of the participants affected by the deficient practice;

b. How the PACE organization will identify other participants who could be affected by the same deficient practice;

c. The measures or systemic changes the PACE organization has or will implement to ensure the deficient practice will not recur, including the responsible staff;

d. How the PACE organization will monitor the corrective action to ensure the deficient practice is corrected and the solution is sustained, including the responsible staff; and

e. The date each plan was or will be completed.

8.497.13.D. Disclosure of review results. The PACE organization must comply with the requirements set forth in 42 CFR § 460.196.

8.497.14DATA COLLECTION, RECORD MAINTENANCE, AND REPORTING

8.497.14.A. Maintenance of records and reporting of data. The PACE organization must collect data, maintain records, and submit reports as required by the Department and in accordance with 42 CFR § 460.200.

8.497.14.B. Participant health outcomes data. The PACE organization must comply with the requirements set forth in 42 CFR § 460.20 2.

8.497.14.C. Financial recordkeeping and reporting requirements. The PACE organization must comply with the requirements set forth in 42 CFR § 460.204.

8.497.14.D. Financial statements.

1. The PACE organization must comply with the financial statement reporting requirements set forth in 42 CFR § 460.208.

2. Annual financial report. A PACE organization must submit the financial data as specified in the PACE contract.

8.497.14.E. Medical records.

1. A PACE organization must maintain a single, comprehensive medical record for each participant in accordance with the requirement set forth in 42 CFR § 460.210.

2. Additional content of medical records. In addition to the medical record content requirements set forth in 42 CFR § 460.210(b), the PACE organization must document whether a service or visit was provided in person or via telehealth.

8.497.14.F. Encounter data submission requirements.

1. Encounter data submission report. A PACE organization must submit encounter data, as directed by the Department, directly to the Department or its designee.

a. The PACE organization must use the Healthcare Common Procedure Coding System (HCPCS), ICD-10 Procedure Coding System (ICD-10 PCS), and Current Procedural Terminology (CPT) for provided services in each submission of encounter data.

b. A PACE organization must prepare and submit all pharmacy and non-pharmacy encounter data monthly, as specified by the Department, to the Department through its Fiscal Agent. Unless otherwise directed by the Department, encounter data must not be submitted to the Department, or its designated Fiscal Agent, more than 30 days from the final day of the previous month.

i. Submissions must be comprised of encounter records or adjustments to previously submitted records from provider encounter or claim records of any contracted or directly provided services rendered to the participant in the current or any prior months.

ii. Submission of encounter records of services rendered from all providers, including PACE organizations and their respective subcontractors, must have a valid, enrolled National Provider Identifier (NPI) with the Department. Subcontractors who submit encounter records to the Department must be enrolled and approved through the Department.

1) If a PACE organization's encounter is not established in the HCPCS, ICD-10 PCS, or CPT, the PACE organization must document the encounter and submit an Encounter Data Submission Report to the Department for review and for coding consideration through a process defined by the Department in collaboration with the PACE organization.

2. Encounter data submission to the Pharmacy Benefit Management (PBM) vendor. A PACE organization must ensure pharmacy encounters are submitted to the PACE organization's PBM vendor.

a. If a business need is identified by the Department, or non-compliance is identified, the Department or the Department's PBM vendor will notify the PACE organization 90 days in advance of any requirement changes that are deemed necessary to ensure compliance, as set forth in the Colorado Pharmacy Benefit Management System Batch Pharmacy Encounters Companion Guide, unless there are unforeseen circumstances that require immediate system changes, in which case the PACE organization will be notified as soon as possible.

3. Annual signed encounter data certification. The PACE organization must submit an Annual Signed Encounter Data Certification to show that the encounter data submitted through the designated Fiscal Agent is accurate to the best of the PACE organization's information, knowledge and belief.

a. The encounter data submission must comply with the format prescribed by the Department or its designated Fiscal Agent. The encounter data submission must include:

i. The name and provider ID of any ordering, referring, prescribing, or attending provider and information on the rendering, operating, or other professional.

1) Generic provider IDs shall be used only when specific Provider IDs remain unknown after reasonable inquiry.

2) NPI numbers of providers not enrolled in Medicaid must be reported.

3) If the NPI is not available, the PACE organization must report the tax payer ID.

ii. The PACE organization must require subcontractors and non-contracting providers to provide encounter data to the PACE organization.

b. The PACE organization must obtain an Annual Signed Encounter Data Certification from either the Chief Executive Officer or the Chief Financial Officer, or an individual who has delegated authority to sign for, and who reports directly to, the Chief Executive Officer or Chief Financial Officer.

c. The PACE organization must provide an Annual Signed Encounter Data Certification to the Department or its designees covering all of the submissions for the preceding year of Encounter Data as specified in the PACE contract.

10 CCR 2505-10-8.497

47 CR 01, January 10, 2024, effective 1/30/2024

47 CR 07, April 10, 2024, effective 4/30/2024