10 Colo. Code Regs. § 2505-10-8.125
Current through Register Vol. 48, No. 1, January 10, 2025
Section 10 CCR 2505-10-8.125 - PROVIDER SCREENING8.125.1DEFINITIONS. Managed Care Entity is defined at 42 CFR § 455.101.
Ownership interest is defined at 42 CFR § 455.101.
Person with an ownership or control interest is defined at 42 CFR § 455.101.
Enrollment is defined as the process by which an individual or entity not currently enrolled as a Colorado Medicaid provider submits a provider application, undergoes any applicable screening, pays an application fee, as appropriate for the provider type, and is approved by the Department for participation in the Medicaid program. Entities that have never previously enrolled as Medicaid providers or whose enrollment was previously terminated and are not currently enrolled are required to enroll. The date of enrollment shall be considered the date that is communicated to the provider in communication from the Department or its fiscal agent verifying the provider's enrollment in Medicaid.
Revalidation is defined as the process by which an individual or entity actively enrolled as a Colorado Medicaid provider resubmits a provider application, undergoes a state-defined screening process, pays an application fee, as appropriate for the provider type, and is approved by the Department to continue participation in the Medicaid program.
Disclosing Entity and Other Disclosing Entity are defined at 42 CFR § 455.101.
8.125.2PROVIDERS DESIGNATED AS LIMITED CATEGORICAL RISK AND NEW PROVIDER TYPES8.125.2.A. Except as provided for in Section 8.125.2.B, provider types not designated as moderate or high categorical risk at Sections 8.125.3 or 8.125.4 shall be considered limited risk.8.125.2.B. The risk category for each provider type designated by CMS shall be the risk category for purposes of this rule regardless of whether a provider type may be listed in Sections 8.125.3 or 8.125.4.8.125.3PROVIDERS DESIGNATED AS MODERATE CATEGORICAL RISK8.125.3.A. Emergency Transportation including ambulance service suppliers8.125.3.B. Community Mental Health Center8.125.3.D. Independent Laboratory8.125.3.E. Comprehensive Outpatient Rehabilitation Facility8.125.3.F. Physical Therapists, both individuals and group practices8.125.3.G. X-Ray Facilities8.125.3.H. Revalidating Home Health agencies8.125.3.I. Revalidating Durable Medical equipment suppliers, including revalidating pharmacies that supply Durable Medical Equipment8.125.3.J. Revalidating Personal Care Agencies under the state plan8.125.3.K. Providers of the following services for HCBS waiver members:1. Alternative Care Facility3. Assistive Technology, if the provider is revalidating6. Behavioral Health Supports9. Children's Case Management10. Children's Habilitation Residential Program (CHRP)12. Community Mental Health Services13. Community Transition Services14. Complementary and Integrative Health19. Home Modifications/Adaptations/Accessibility20. Independent Living Skills Training21. In-Home Support Services, if the provider is revalidating22. Intensive Case Management25. Non-Medical Transportation26. Palliative/Supportive Care Skilled28. Personal Care/Homemaker Services, if the provider is revalidating29. Personal Emergency Response System/Medication Reminder/Electronic Monitoring30. Prevocational Services31. Professional Services32. Residential Habilitation Services34. Specialized Day Rehabilitation Services35. Specialized Medical Equipment and Supplies, if the provider is revalidating36. Substance Abuse Counseling38. Supported Living Program39. Therapy and Counseling40. Transitional Living Program8.125.3.L. Medicare Only Providers 1. Independent Diagnostic Testing Facility2. Revalidating Medicare Diabetes Prevention Program Supplier3. Newly enrolling Opioid Treatment Program that has been fully and continuously certified by Substance Abuse and Mental Health Services Administration (SAMHSA) since October 24, 2018.4. Revalidating Opioid Treatment Program8.125.4PROVIDERS DESIGNATED AS HIGH CATEGORICAL RISK8.125.4.A. Enrolling DME Suppliers8.125.4.B. Enrolling Home Health Agencies8.125.4.C. Enrolling Personal Care Agencies providing services under the state plan8.125.4.D. Enrolling providers of the following services for HCBS waiver members: 2. Personal Care/Homemaker Services 3 Specialized Medical Equipment and Supplies4 In-Home Support Services8.125.4.E. Non-Emergent Medical Transportation8.125.4.F. Medicare Only Providers 1. Enrolling Medicare Diabetes Prevention Program Supplier2. Enrolling Opioid Treatment Program that has not been fully and continuously certified by SAMHSA since October 24, 2018.8.125.4.G. Enrolling and revalidating providers for which the Department has suspended payments during an investigation of a credible allegation of fraud, for the duration of the suspension of payments.8.125.4.H. Enrolling and revalidating providers which have a delinquent debt owed to the State arising out of Medicare, Colorado Medical Assistance or other programs administered by the Department, not including providers which are current under a settlement or repayment agreement with the State.8.125.4.I. Providers that were excluded by the HHS Office of Inspector General or had their provider agreement terminated for cause by the Department, its contractors or agents or another State's Medicaid program at any time within the previous 10 years.8.125.4.J. Providers applying for enrollment within six (6) months from the time that the Department or CMS lifts a temporary enrollment moratorium on the provider's enrollment type.8.125.5PROVIDERS WITH MULTIPLE RISK LEVELS8.125.5.A. Providers shall be screened at the highest applicable risk level for which a provider meets the criteria. Providers shall only pay one application fee per location.8.125.6PROVIDERS WITH MULTIPLE LOCATIONS8.125.6.A. Providers must enroll separately each location from which they provide services. Only claims for services provided at locations that are enrolled are eligible for reimbursement.8.125.6.B. Each provider site will be screened separately and must pay a separate application fee. Providers shall only pay one application fee per location.8.125.7ENROLLMENT AND SCREENING OF PROVIDERS8.125.7.A. All enrolling and revalidating providers must be screened in accordance with requirements appropriate to their categorical risk level.8.125.7.B. Notwithstanding any other provision of the Colorado Code of Regulations, providers who provide services to Medicaid members as part of a managed care entity's provider network who would have to enroll in order to participate in fee-for-service Medicaid must enroll with the Department and be screened as Medicaid providers.8.125.7.C. Nothing in Section 8.125.7.B shall require a provider who provides services to Medicaid members as part of a managed care entity's provider network to participate in fee-for-service Medicaid.8.125.7.D. All physicians or other professionals who order, prescribe, or refer services or items for Medicaid members, whether as part of fee-for-service Medicaid or as part of a managed care entity's provider network under either the state plan, the Children's Health Insurance Program, or a waiver, must be enrolled in order for claims submitted for those ordered, referred, or prescribed services or items to be reimbursed or accepted for the calculation of managed care rates by the Department.8.125.7.E. The Department may exempt certain providers from all or part of the screening requirements when certain providers have been screened, approved and enrolled or revalidated:1. By Medicare within the last 5 years, or2. By another state's Medicaid program within the last 5 years, provided the Department has determined that the state in which the provider was enrolled or revalidated has screening requirements at least as comprehensive and stringent as those for Colorado Medicaid.8.125.7.F. The Department may deny a Provider's enrollment or terminate a Provider agreement for failure to comply with screening requirements.8.125.7.G. The Department may terminate a Provider agreement or deny the Provider's enrollment if CMS or the Department determines that the provider has falsified any information provided on the application or cannot verify the identity of any provider applicant.8.125.8NATIONAL PROVIDER IDENTIFIER FOR ORDERING, PRESCRIBING, REFERRING8.125.8.A. As a condition of reimbursement, any claim submitted for a service or item that was ordered, referred, or prescribed for a Medicaid member must contain the National Provider Identifier (NPI) of the ordering, prescribing or referring physician or other professional.8.125.9VERIFICATION OF PROVIDER LICENSES8.125.9.A. If a provider is required to possess a license or certification in order to provide services or supplies in the State of Colorado, then that provider must be so licensed as a condition of enrollment as a Medicaid provider.8.125.9.B. Required licenses must be kept current and active without any current limitations throughout the term of the agreement.8.125.10REVALIDATION8.125.10.A. Actively enrolled providers must complete all requirements for revalidation at least every 5 years as established by the Department, or upon request from the Department for an off cycle review.8.125.10.B. The date of revalidation shall be considered the date that the provider's application was initially approved plus 5 years, or by an off-cycle request from the Department.8.125.10.C. If a provider fails to comply with any requirement for revalidation by the deadlines established by Sections 8.125.10.A. or 8.125.10.B., the provider agreement may be terminated. In the event that the provider agreement is terminated pursuant to this section, any claims for dates of service submitted after deadlines established by Sections 8.125.10.A. or 8.125.10.B., are not reimbursable beginning on the day after the date indicated by Section 8.125.10.B.8.125.11SITE VISITS8.125.11.A. All providers designated as "moderate" or "high" categorical risks to the Medicaid program must consent to and pass a site visit before they may be enrolled or re-validated as Colorado Medicaid providers. The purpose of the site visit is to verify that the information submitted to the state department is accurate and to determine compliance with federal and state enrollment requirements.8.125.11.B. All enrolled providers who are designated as "moderate" or "high" categorical risks must consent to and pass an additional site visit after enrollment or revalidation. The purpose of the site visit is to verify that the information submitted to the state department is accurate and to determine compliance with federal and state enrollment requirements. Post-enrollment or post- revalidation site visits may occur anytime during the five-year period after enrollment or revalidation.8.125.11.C. All providers enrolled in the Colorado Medicaid program must permit CMS, its agents, its designated contractors, the State Attorney General's Medicaid Fraud Control Unit or the Department to conduct unannounced on-site inspections of any and all provider locations8.125.11.D. All site visits shall verify the following information: 1. Basic Information including business name, address, phone number, on-site contact person, National Provider Identification number and Employer Identification Number, business license, provider type, owner's name(s), and owner's interest in other medical businesses.2. Location including appropriate signage, utilities that are turned on, the presence of furniture and applicable equipment, and disability access where applicable and where clients are served at the business location.3. Employees with relevant training, designated employees who are trained to handle Medicaid billing, where applicable, and resources the provider uses to train employees in Medicaid billing where applicable.4. Appropriate inventory necessary to provide services for specific provider type.5. Other information as designated by the Department.8.125.11.E. The Department shall give the provider a report detailing the discrepancies or insufficiencies in the information disclosed by the provider and the criteria the provider failed to meet during the site visit.8.125.11.F. Providers that are found in full compliance shall be recommended for approval of enrollment or revalidation, subject to other enrollment or revalidation requirements.8.125.11.G. Providers who meet the vast majority of criteria in 8.125.11.D but have small number of minor discrepancies or insufficiencies shall have 60 days from the date of the issuance of the report in 8.125.11.E to submit documentation to the Department attesting that the provider has corrected the issues identified during the site visit. 1. If the provider submits attestation within the 60 day timeframe and has met requirements, then the provider shall be recommended for enrollment or revalidation, subject to the verification of other enrollment or revalidation requirements.2. If the provider fails to submit the attestation in 8.125.11.G.1 within the 60 day deadline, the Department may deny the provider's application for enrollment or revalidation.3. If the provider submits an attestation within 60 days indicating that the provider is not fully compliant with criteria in 8.125.11.D, then the Department may, a. For existing providers, suspend the provider, until the provider demonstrates compliance in a subsequent site visit, conducted at the provider's expense; orb. For new providers, deny the application and require the provider to restart the enrollment process.8.125.11.H. When site visits reveal major discrepancies or insufficiencies in the information provided in the enrollment application or a majority of the criteria described in 8.125.11.D are not met, the Department shall allow for an additional site visit for the provider.1. Additional site visits shall be conducted at the provider's expense.2. The provider shall have 14 days from the date of the issuance of the report listed in 8.125.11.E above to request an additional site visit.3. The Department shall deny or terminate enrollment or revalidation of any provider subject to 8.125.11.G who does not request an additional site visit within 14 days.4. If the Department determines that a provider is not in full compliance upon the additional site visit:a. for a revalidating provider, the Department shall immediately suspend the provider until a subsequent site visit demonstrates provider is in compliance.b. for an enrolling provider, deny the application and require the provider to restart the enrollment process.8.125.11.I. The Department shall deny or terminate enrollment or revalidation of any provider who refuses to allow a site visit, unless the Department determines the provider or the provider's staff refused the on-site inspection in error. The provider must provide credible evidence to the Department that it refused the on-site inspection in error within in 7 days of the date of the issuance of the report in 8.125.11.E. Any provider who does not provide credible evidence to the Department that it refused the on-site inspection in error shall be denied or terminated from enrollment or revalidation.8.125.11.J. The Department shall deny an application or terminate a provider's enrollment when an on-site inspection provides credible evidence that the provider has committed Medicaid fraud.8.125.11.K. The Department shall refer providers in 8.125.11.J to the State Attorney General.8.125.12CRIMINAL BACKGROUND CHECKS AND FINGERPRINTING8.125.12.A. As a condition of provider enrollment, any person with an ownership or control interest in a provider designated as "high" categorical risk to the Medicaid program, must consent to criminal background checks and submit a set of fingerprints, in a form and manner to be determined by the Department.8.125.12.B. Any provider, and any person with an ownership or control interest in the provider, must consent to criminal background checks and submit a set of fingerprints, in a form and manner designated by the Department, within 30 days upon request from CMS, the Department, the Department's agents, or the Department's designated contractors.8.125.13APPLICATION FEE8.125.13.A. Except when exempted in Sections 8.125.13.C and 8.125.13.D, enrolling and re- validating providers must submit an application fee or a formal request for a hardship exemption with their application.8.125.13.B. The amount of the application fee is the amount calculated by CMS in accordance with17 42 CFR § 424.514(d).8.125.13.C. Application fees shall apply to all providers except:1. Individual practitioners2. Providers who have enrolled or re-validated in Medicare and paid an application fee within the last 12 months3. Providers who have enrolled or re-validated in another State's Medicaid or Children's Health Insurance Program and paid an application fee within the last 12 months provided that the Department has determined that the screening procedures in the state in which the provider is enrolled are at least as comprehensive and stringent as the screening procedures required for enrollment in Colorado Medicaid.8.125.13.D. The Department may exempt a provider, or group of providers, from paying the applicable application fee, through a hardship exemption request or categorical fee waiver, if: 1. The Department determines that requiring a provider to pay an application fee would negatively impact access to care for Medicaid clients, and2. The Department receives approval from the Centers for Medicare and Medicaid Services to exempt the application fee.8.125.13.E. A provider may not be enrolled or revalidated unless the provider has either paid any applicable application fee or obtained an exemption described at Section 8.125.13.D.8.125.13.F. The application fee is non-refundable, except if submitted with one of the following: 1. A request for hardship exemption described at Section 8.125.13.D, that is subsequently approved;2. An application that is rejected prior to initiation of screening processes;3. An application that is subsequently denied as a result of the imposition of a temporary moratorium as described at Section 8.125.14.8.125.14TEMPORARY MORATORIA8.125.14.A. In consultation with CMS and HHS, the Department may impose temporary moratoria on the enrollment of new providers or provider types, or impose numerical caps or other limits on providers that the Department and the Secretary of HHS identify as being a significant potential risk for fraud, waste, or abuse, unless the Department determines that such an action would adversely impact Medicaid members' access to medical assistance.8.125.14.B. Before imposing any moratoria, caps, or other limits on provider enrollment, the Department shall notify the Secretary of HHS in writing and include all details of the moratoria.8.125.14.C. The Department shall obtain the Secretary of HHS's concurrence with imposition of the moratoria, caps, or other limits on provider enrollment, before such limits shall take effect.8.125.15DISCLOSURES BY MEDICAID PROVIDERS, MANAGED CARE ENTITIES, MEDICARE PROVIDERS AND FISCAL AGENTS8.125.15.A. All providers, disclosing entities, fiscal agents, and managed care entities must provide the following federally required disclosures to the Department: 1. The name and address of any entity (individual or corporation) with an ownership or control interest in the disclosing entity, fiscal agent, or managed care entity having direct or indirect ownership of 5 percent or more. The address for corporate entities must include, as applicable, primary business address, every business location, and P.O. Box address.2. For individuals: Date of birth and Social Security number3. For business entities: Other tax identification number for any entity with an ownership or control interest in the disclosing entity (or fiscal agent or managed care entity) or in any subcontractor in which the disclosing entity (or fiscal agent or managed care entity) has a 5 percent or more interest.4. Whether the entity (individual or corporation) with an ownership or control interest in the disclosing entity (or fiscal agent or managed care entity) is related to another person with ownership or control interest in the disclosing entity as a spouse, parent, child, or sibling; or whether the entity (individual or corporation) with an ownership or control interest in any subcontractor in which the disclosing entity (or fiscal agent or managed care entity) has a 5 percent or more interest is related to another person with ownership or control interest in the disclosing entity as a spouse, parent, child, or sibling.5. The name of any other disclosing entity (or fiscal agent or managed care entity) in which an owner of the disclosing entity (or fiscal agent or managed care entity) has an ownership or control interest.6. The name, address, date of birth, and Social Security Number of any managing employee of the disclosing entity (or fiscal agent or managed care entity).7. The identity of any person who has an ownership or control interest in the provider, or is an agent or managing employee of the provider who has been convicted of a criminal offense related to that person's involvement in any program under Medicare, Medicaid, Children's Health Insurance Program or the Title XX services since the inception of these programs.8. Full and complete information about the ownership of any subcontractor with whom the provider has had business transactions totaling more than $25,000 during the 12 month period ending on the date of the request; and any significant business transactions between the provider and any wholly owned supplier, or between the provider and any subcontractor, during the 5-year period ending on the date of the request.8.125.15.B. Disclosures from any provider or disclosing entity are due at any of the following times: 1. Upon the provider or disclosing entity submitting the provider application.2. Upon the provider or disclosing entity executing the provider agreement.3. Upon request of the Department during revalidation.4. Within 35 days after any change in ownership of the disclosing entity.8.125.15.C. Disclosures from fiscal agents are due at any of the following times:1. Upon the fiscal agent submitting its proposal in accordance with the State's procurement process.2. Upon the fiscal agent executing a contract with the State.3. Upon renewal or extension of the contract.4. Within 35 days after any change in ownership of the fiscal agent.8.125.15.D. Disclosures from managed care entities are due at any of the following times: 1. Upon the managed care entity submitting its proposal in accordance with the State's procurement process.2. Upon the managed care entity executing a contract with the State.3. Upon renewal or extension of the contract.4. Within 35 days after any change in ownership of the managed care entity.8.125.15.E. The Department will not reimburse any claim from any provider or entity or make any payment to an entity that fails to disclose ownership or control information as required by 42 CFR § 455.104. The Department will not reimburse any claim from any provider or entity or make any payment to an entity that fails to disclose information related to business transactions as required by 42 CFR § 455.105 beginning on the day following the date the information was due and ending on the day before the date on which the information was supplied. Any payment made to a provider or entity that is not reimbursable in accordance with this section shall be considered an overpayment.8.125.15.F. The Department may terminate the agreement of any provider or entity or deny enrollment of any provider that fails to disclose information when requested or required by 42 CFR § 455.100-106.38 CR 11, June 10, 2015, effective 7/1/201543 CR 11, June 10, 2020, effective 6/30/202046 CR 01, January 10, 2023, effective 1/1/202346 CR 07, April 10, 2023, effective 4/30/202347 CR 03, February 10, 2024, effective 1/12/2024, exp. 5/11/2024 (Emergency)47 CR 07, April 10, 2024, effective 4/30/2024