Part I. Definitions and General Information
12VAC5-408-10. Definitions.
The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:
"Adverse decision" means a utilization review determination by the utilization review entity that a health service rendered or proposed to be rendered was not or is not medically necessary, when such determination may result in noncoverage of the health service or health services. When the policy, contract, plan, certificate, or evidence of coverage includes coverage for prescription drugs and the health service rendered or proposed to be rendered is a prescription for the alleviation of cancer pain, any adverse decision shall be made within 24 hours of the request for coverage.
"Appeal" means a formal request by a covered person or a provider on behalf of a covered person for reconsideration of a decision, such as a final adverse decision, a benefit payment, a denial of coverage, or a reimbursement for service.
"Basic health care services" means those health care services, as applicable to the type of managed care health insurance plan, described in § 38.2-5800 of the Code of Virginia which are required to be provided, arranged, paid for, or reimbursed by the managed care health insurance plan licensee for its covered persons.
"Board" means the Board of Health.
"Bureau of Insurance" means the State Corporation Commission acting pursuant to Title 38.2 of the Code of Virginia.
"Center" means the Center for Quality Health Care Services and Consumer Protection of the Virginia Department of Health.
"Certificate" means a certificate of quality assurance.
"Complaint" means a written communication from a covered person primarily expressing a grievance. A complaint may pertain to the availability, delivery, or quality of health care services including claims payments, the handling or reimbursement for such services, or any other matter pertaining to the covered person's contractual relationship with the MCHIP.
"Covered person" means an individual residing in the Commonwealth, whether a subscriber, policyholder, enrollee, or member, of a managed care health insurance plan (MCHIP), who is entitled to health services or benefits provided, arranged for, paid for, or reimbursed pursuant to an MCHIP.
"Delegated service entity" means the entity with which an MCHIP licensee contracts to provide one or more of the services listed in 12VAC5-408-320 A for one or more of its MCHIPs, pursuant to and in accordance with the provisions of Part VI (12VAC5-408-320 et seq.) of this chapter, inclusive.
"Department" means the Virginia Department of Health.
"Emergency services" means those health care services as defined in § 38.2-3438 of the Code of Virginia.
"Evidence of coverage" means any certificate, individual or group agreement or contract, or identification card or related document issued in conjunction with the certificate, agreement or contract, issued to a covered person setting out the coverage and other rights to which a covered person is entitled.
"Final adverse decision" means a utilization review determination made by a physician advisor or peer of the treating health care provider in a reconsideration of an adverse decision, and upon which a provider or patient may base an appeal.
"Health care data reporting system" means the state contracted integrated system for the collection and analysis of data used by consumers, employers, providers, and purchasers of health care to continuously assess and improve the quality of health care in the Commonwealth.
"Health care provider" or "provider" has the same meaning ascribed to the term in § 32.1-127.1:03 B of the Code of Virginia.
"Health care services" means services as defined in § 38.2-3438 of the Code of Virginia.
"Health carrier" means an entity as defined in § 38.2-3438 of the Code of Virginia.
"Managed care health insurance plan" or "MCHIP" means an arrangement for the delivery of health care in which a health carrier, as defined in § 38.2-5800 of the Code of Virginia, undertakes to provide, arrange for, pay for, or reimburse any of the costs of health care services for a covered person on a prepaid or insured basis which (i) contains one or more incentive arrangements, including any credentialing requirements intended to influence the cost or level of health care services between the health carrier and one or more providers with respect to the delivery of health care services and (ii) requires or creates benefit payment differential incentives for covered persons to use providers that are directly or indirectly managed, owned, under contract with or employed by the health carrier. Any health maintenance organization as defined in § 38.2-4300 of the Code of Virginia or health carrier that offers preferred provider contracts or policies as defined in § 38.2-3407 of the Code of Virginia or preferred provider subscription contracts as defined in § 38.2-4209 of the Code of Virginia shall be deemed to be offering one or more managed care health insurance plans. For the purposes of this definition, the prohibition of balance billing by a provider shall not be deemed a benefit payment differential incentive for covered persons to use providers who are directly or indirectly managed, owned, under contract with or employed by the health carrier. A single managed care health insurance plan may encompass multiple products and multiple types of benefit payment differentials; however, a single managed care health insurance plan shall encompass only one provider network or set of provider networks.
"Managed care health insurance plan licensee" or "MCHIP licensee" means a health carrier subject to licensure by the Bureau of Insurance and to quality assurance certification by the department under Title 38.2 of the Code of Virginia who is responsible for a managed care health insurance plan in accordance with Chapter 58 (§ 38.2-5800 et seq.) of Title 38.2 of the Code of Virginia.
"Managed care plan" means a health benefit plan, as defined in § 38.2-3407.10:1 of the Code of Virginia, that requires a covered person to use, or creates incentives, including financial incentives, for a covered person to use health care providers managed, owned, under contract with, or employed by the MCHIP licensee.
"Material" means that which has an effective influence or bearing on, or is pertinent to, the issue in question.
"Medical necessity" or "medically necessary" means appropriate and necessary health care services which are rendered for any condition which, according to generally accepted principles of good medical practice, requires the diagnosis or direct care and treatment of an illness, injury, or pregnancy-related condition, and are not provided only as a convenience.
"Nationally recognized accrediting body" means an organization that sets national standards specifically governing healthcare quality assurance processes, utilization review, provider credentialing, as well as other areas covered by this chapter and provides accreditation to managed care health insurance plans pursuant to national standards. The following entities shall be considered nationally recognized accrediting bodies:
1. The American Accreditation HealthCare Commission/URAC;
2. The National Committee for Quality Assurance (NCQA);
3. The Joint Commission on Accreditation of Healthcare Organizations, (JCAHO); and
4. Other nationally recognized accrediting bodies with national standards as described above that are accepted by the department.
"Network" means a group of providers as defined in § 38.2-3438 of the Code of Virginia.
"New provider applicant" means a provider that has submitted a completed credentialing application to an MCHIP licensee.
"Participating provider" means a provider that is managed, under contract with, or employed by an MCHIP licensee and who has agreed to provide health care services to covered persons with an expectation of receiving payments, other than coinsurance, copayments, or deductibles, directly or indirectly from the MCHIP licensee.
"Person" means any individual, aggregate of individuals, association, business, company, corporation, joint-stock company, Lloyds type of organization, other organization, partnership, receiver, reciprocal or inter-insurance exchange, trustee or society.
"Plan of correction" means an MCHIP'S written plan that outlines the action the MCHIP will take to address compliance issues identified during an administrative review or on-site examination conducted by the department.
"Preferred provider organization" or "PPO" means an arrangement in which a health carrier, as defined in § 38.2-5800 of the Code of Virginia, undertakes to provide, arrange for, pay for, or reimburse any of the costs of health care services, on an insured basis, which creates incentives, including financial incentives, for a covered person to use health care providers directly or indirectly managed, owned, under contract with, or employed by the health carrier, but shall not include a health maintenance organization as defined in § 38.2-4300 of the Code of Virginia.
"Quality assurance program" means the systems, standards and processes including, but not limited to, reasonable and adequate systems to assess, measure, and improve the health status of covered persons, necessary to obtain a certificate of quality assurance from the department in accordance with this chapter and in accordance with § 32.1-137.2 C of the Code of Virginia.
"Service area" means a geographic area as defined in § 38.2-5800 of the Code of Virginia.
"Timely" means the provision of services so as not to impair or jeopardize the integrity of the covered persons' diagnosis or outcomes of illness.
"Treating health care provider" means a licensed health care provider who renders or proposes to render health care services to a covered person.
"Utilization review" means a system for reviewing the necessity, appropriateness, and efficiency of hospital, medical or other health care services rendered or proposed to be rendered to a patient or group of patients for the purpose of determining whether such services should be covered or provided by an insurer, health services plan, managed care health insurance plan licensee, or other entity or person. For purposes of this chapter, "utilization review" shall include, but not be limited to, preadmission, concurrent and retrospective medical necessity determination, and review related to the appropriateness of the site at which services were or are to be delivered. "Utilization review" shall not include (i) review of issues concerning insurance contract coverage or contractual restrictions on facilities to be used for the provision of services, (ii) any review of patient information by an employee of or consultant to any licensed hospital for patients of such hospital, or (iii) any determination by an insurer as to the reasonableness and necessity of services for the treatment and care of an injury suffered by an insured for which reimbursement is claimed under a contract of insurance covering any classes of insurance defined in §§ 38.2-117 through 38.2-119, 38.2-124 through 38.2-126, 38.2-130 through 38.2-132 and 38.2-134 of the Code of Virginia.
"Utilization review entity" means a person or entity performing utilization review.
"Utilization review plan" means a written procedure for performing a utilization review.
Statutory Authority
§§ 32.1-12 and 32.1-137.3 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002; Volume 28, Issue 4, eff. November 23, 2011; Volume 37, Issue 14, eff. April 15, 2021.
12VAC5-408-20. Responsibility of the department.
A. The Code of Virginia allows the Board of Health to adopt regulations for the certification of quality assurance for managed care health insurance plans licensees. The Department of Health is charged with the responsibility for examining the quality of health care services provided by, arranged for, paid for, or reimbursed by managed care health insurance plan licensees according to regulations adopted by the board and any additional requirements that may be specified by the Code of Virginia. The Center for Quality Health Care Services and Consumer Protection acts as agent for the department for certifying managed care health insurance plans, which includes investigating complaints made against an MCHIP licensee.
B. In developing or revising these regulations, the department adheres to the requirements of the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia) and the public participation process. The department solicits input from MCHIPs, associations of MCHIPs, providers, experts in related fields, advocacy organizations, consumers and the general public in the development or revision of this chapter through informal and formal comment periods and public hearings.
C. The department shall coordinate its activities with the Bureau of Insurance to ensure an appropriate level of regulatory oversight and to avoid undue duplication of effort or regulation.
Statutory Authority
§ 32.1-137.1 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.
12VAC5-408-30. Certificate of quality assurance.
A. A certificate for quality assurance shall be issued to managed care health insurance plan licensees. The commissioner shall issue or renew a certificate of quality assurance if the MCHIP licensee is in compliance with the applicable law and this chapter. On behalf of the commissioner, and under a written delegation of authority, the department shall examine the applicants and issue the certificates for quality assurance.
B. No certificate of quality assurance may be transferred or assigned without approval of the department.
C. Every certified MCHIP licensee shall file for its certificate of quality assurance with the department biennially, subject to payment of a fee and receipt of all material required by law and this chapter.
D. Upon request, the center will provide an application form for a certificate of quality assurance. The center shall consider the application complete when all the information requested and the application fee are submitted. If the center finds the application incomplete, the applicant will be notified in writing of receipt of the incomplete application.
E. The department shall send an application for renewal of a certificate to the licensee at least 90 days prior to the expiration date of the current certificate.
F. The department shall examine or review each applicant for an initial certificate of quality assurance and periodically for renewal thereof.
G. Upon receipt of a written request from the governing body of an MCHIP licensee, the commissioner, in her sole discretion, may consider a modification and issue a temporary or permanent variance in the application of one or more of these regulations provided patient safety, care, or the ability of an MCHIP licensee to provide, arrange for, or reimburse the cost of services will not be adversely affected. The written request shall identify the reason the MCHIP licensee cannot immediately comply with the specified regulation and how any proposed modification is equal to or will meet the intent of the regulation for which a variance is requested. Upon review of the request, the commissioner may grant a temporary variance for less than a full period of certification, or a permanent variance for a full period of certification, or deny the request. Any temporary or permanent variance granted by the commissioner shall be subject to review and renewal before a certificate renewal, extension or re-issuance is granted.
H. Upon the issuance or renewal of a certificate, the department, on behalf of the commissioner and under a written delegation of authority, shall provide a certificate of quality assurance to the MCHIP licensee and a copy to the Bureau of Insurance.
I. Upon determining to deny or refuse to renew a certificate, the department, on behalf of the commissioner and under a written delegation of authority, shall notify the applicant in writing stating the reasons for the denial of the certificate. A copy of the notification of denial shall be provided to the Bureau of Insurance.
J. Appeals from a notification of denial shall be brought by a certificate applicant pursuant to the process set forth in 12VAC5-408-140.
Statutory Authority
§ 32.1-137.1 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.
12VAC5-408-40. Fees.
A. The center shall collect a fee for each initial application and each renewal application. MCHIP licensees with multiple plans wishing to submit a separate application for each plan must include the appropriate fee for each application. Fees shall accompany the application and are not refundable.
B. Fees shall be sufficient to cover reasonable costs for the administration of the quality assurance program.
C. Fees shall be based upon a percentage, not to exceed 1/10 of 1.0%, of the proportion of direct gross premium income on business done in this Commonwealth attributable to the operation of managed care health insurance plans in the preceding biennium not to exceed $10,000 per plan submitted by the licensee for separate certification.
After July 2000, applicants proposing to offer MCHIP plans in the Commonwealth shall be assessed a flat fee of $5,000 for the initial application for a certificate of quality assurance.
Statutory Authority
§ 32.1-137.1 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.
12VAC5-408-50. Compliance provisions appropriate for type of plan.
A. Managed care health insurance plan licensees that offer one or more PPO plans as defined in this chapter must require their PPO plans to only comply with the following sections:
1. Parts I (12VAC5-408-10 et seq.) and II (12VAC5-408-160 et seq.) of this chapter;
2. Part III (12VAC5-408-220 et seq.) of this chapter except for subdivision 1 of 12VAC5-408-220 and subdivisions 2 and 10 of 12VAC5-408-240;
3. 12VAC5-408-260 through 12VAC5-408-280 of this chapter except subsection E of 12VAC5-408-260, subsections D and E of 12VAC5-408-270 and subsection G of 12VAC5-408-280; and
4. Parts VI (12VAC5-408-320 et seq.) and VII (12VAC5-408-360) of this chapter.
The MCHIP licensee may comply with 12VAC5-408-170, 12VAC5-408-200, as well as subdivisions A 2 through A 4 of this section, by demonstrating it operates a PPO plan in conformity with the standards of a nationally recognized accrediting body applicable to preferred provider organizations and acceptable to the department. While such demonstration shall be considered reasonable and adequate compliance for purposes of initial and renewal MCHIP certification, the department may employ a checklist to identify and determine compliance with specific statutory or regulatory requirements that are more stringent than the nationally recognized accrediting body standards.
B. Managed care health insurance plan licensees other than PPO plans, including health maintenance organizations, must comply with this entire chapter. The MCHIP licensee may comply with 12VAC5-408-170, 12VAC5-408-200, 12VAC5-408-210, as well as Parts III through VII (12VAC5-408-220 through 12VAC5-408-360) of this chapter by demonstrating that the MCHIP licensee operates in conformity with the standards of a nationally recognized accrediting body that are appropriate for the type of MCHIP corresponding to the licensee and acceptable to the department. Such demonstration shall be considered reasonable and adequate compliance for purposes of initial and renewal MCHIP certification. Nothing in the preceding sentences shall preclude the department from imposing further requirements if the regulatory requirements are more stringent than the nationally recognized accrediting body's standards.
C. Accreditation by a nationally recognized accrediting body shall satisfy the department in demonstrating that the MCHIP licensee operates in conformity with the standards of a nationally recognized accrediting body as permitted under subsection A or B of this section, provided the MCHIP licensee follows the provisions of 12VAC5-408-100 to be eligible for exemption from examination. Otherwise, an MCHIP that is not accredited shall be subject to the triennial comprehensive onsite examination requirements of 12VAC5-408-90. Nothing in the preceding sentences shall preclude the department from imposing further requirements if the regulatory requirements are more stringent than the nationally recognized accrediting body's standards.
Statutory Authority
§ 32.1-137.1 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.
12VAC5-408-60. General examination process.
A. The commissioner shall cause MCHIP licensees to be examined or reviewed by the department according to Article 1.1 (§ 32.1-137.1 et seq.) of Chapter 5 of Title 32.1 of the Code of Virginia to:
1. Verify that an MCHIP qualifies for an initial or renewal certificate of quality assurance;
2. Investigate a complaint filed against an MCHIP licensee;
3. Determine compliance with this chapter and applicable law; and
4. Determine if the MCHIP licensee has successfully implemented corrective action following an examination, or as a result of disciplinary action or sanction.
B. Examinations may be conducted onsite at an MCHIP licensee's office and at the site of any delegated service provider. At its discretion, the department may choose to conduct an administrative review to evaluate the MCHIP for compliance with applicable law and this chapter. The MCHIP's examination may also include contractors with whom the licensee has agreements, contracts, or other arrangements to provide health care services for the MCHIP.
C. Any examiner authorized by the department shall, so far as necessary for the purposes of the examination or review, have access during regular business hours to the premises and to any books, records, files, or property of the licensee as far as they directly relate to this regulation and Articles 1.1 (§ 32.1-137.1 et seq.) and 1.2 (§ 32.1-137.7 et seq.) of Chapter 5 of Title 32.1 of the Code of Virginia.
All material copied, recorded, or received by the department from the MCHIP licensee shall be privileged and confidential and shall not be subject to subpoena.
D. The MCHIP licensee shall be responsible for ensuring that all examination materials are submitted to the department at the time specified for submission and that they are complete. Failure to submit all of the examination materials as required may delay processing or result in the denial of the issuance or renewal of the quality assurance certificate.
E. A summary report of an MCHIP licensee's examination shall become part of the department's public file on the MCHIP. A copy of the summary report shall be provided to the Bureau of Insurance.
F. The department shall consider an MCHIP licensee's initial examination for a certificate of quality assurance as an evaluation of the MCHIP's quality assurance program in order to determine if it has the structure, organization, and policies and procedures in place to provide and support quality improvement activities.
G. Information provided during any examination conducted regarding compliance with this chapter shall be accurate and truthful. The MCHIP licensee shall not provide the department with falsified information during any aspect of the examination process. The department shall construe any effort to provide falsified information as violation of the statute, and the MCHIP licensee shall be subject to disciplinary action. Falsification is defined for the purpose of this chapter as fabrication, in whole or in part, of any information provided by the MCHIP or the MCHIP licensee.
H. The refusal of any MCHIP licensee, by its officers, directors, employees or agents, to submit to examination or review or to comply with any reasonable written request of the examiners shall be grounds for suspension, revocation, denial, or nonrenewal of a certificate of quality assurance held by the licensee.
Statutory Authority
§ 32.1-137.1 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.
12VAC5-408-70. Administrative review.
A. The initial examination shall be an administrative review of the application for certificate of quality assurance and supporting documentation that includes:
1. The items listed in subsections F, G, H, and I of 12VAC5-408-160, except that if the MCHIP is accredited by a nationally recognized accrediting body appropriate for the type of MCHIP and approved by the department, it shall not be required to include in its application the items listed in subdivisions F 5, G 2, G 3, G 7 and subsection I;
2. A copy of the most recent accreditation report executive summary, as applicable issued to the MCHIP or to the MCHIP's licensee from a nationally recognized accrediting body that evaluates quality assurance programs, with the written corrective action response, if any;
3. For MCHIP licensees that have been cited by another state or the District of Columbia concerning their quality assurance program, a copy of the most recent report of an examination of the quality of health care provided by the MCHIP under similar laws and regulations of another state, with a copy of the written corrective action response, if any;
4. The most recent report of any examination of the quality assurance program provided by the MCHIP issued by a federal regulatory agency with similar laws and regulations. Submission of this report shall not be necessary if the MCHIP provides a copy of the report required by subdivision 2 of this subsection with the written corrective action plan, if any; and
5. The department may coordinate with the Bureau of Insurance to obtain information that may assist its review.
B. The administrative review examination shall be conducted within 45 business days of the receipt of all the documentation required by the department. The MCHIP licensee shall be notified in writing if additional information is needed to clarify the information submitted and the specific time period in which to submit the materials. Accreditation by a nationally recognized accrediting body appropriate to the type of MCHIP and acceptable to the department shall be sufficient to demonstrate compliance with state requirements pursuant to 12VAC5-408-50. Nothing in the preceding sentences shall preclude the department from imposing further requirements if the regulatory requirements are more stringent than the nationally recognized accrediting body's standards.
C. The MCHIP licensee shall be notified of the results of the administrative review examination within 60 business days from the receipt by the department of all of the required documents and related information.
The department, at its discretion, may extend, for up to an additional 30 days, the period of time within which to approve or disapprove the information submitted. Licensees shall be notified in writing of any such extension.
D. The department, at its discretion, may conduct an onsite examination of the MCHIP licensee's quality assurance program if, for example, during its conduct of the administrative review examination, the department determines that an onsite examination is warranted in order to determine the MCHIP licensee's compliance with applicable laws or this chapter.
E. Licensees with MCHIPs that successfully complete the examination shall be issued a certificate of quality assurance. Licensees with MCHIPs that do not successfully complete the examination shall be denied a certificate of quality assurance. Licensees with more than one MCHIP requesting separate certificates for each MCHIP shall file a separate certificate of quality assurance application for any of their MCHIPs with an accompanying fee. Each of the licensee's MCHIPs that were filed with separate applications that successfully complete the examination shall be issued a certificate of quality assurance. Each of the licensee's MCHIPs that were filed with separate applications that do not successfully complete the examination shall be denied a certificate of quality assurance.
Statutory Authority
§ 32.1-137.1 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; Errata, 16:7 VA.R. 823 December 20, 1999; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.
12VAC5-408-80. Renewal application.
A. Every MCHIP licensee shall request renewal of its certificate of quality assurance biennially with the department. The purpose of the renewal examination shall be to determine if the MCHIP has maintained compliance with applicable laws and regulations since the last certificate of quality assurance was issued or renewed, and whether the MCHIP is using its best efforts to meet its quality assurance goals as set forth in its quality assurance plan.
B. The renewal examination shall include an administrative review of the renewal application and supporting documentation that includes:
1. The items listed in subsections F, G, H, and I of 12VAC5-408-160, except that if the MCHIP is accredited by a nationally recognized accrediting body appropriate for the type of MCHIP and acceptable to the department, it shall not be required to include in its application the items listed in subdivisions F 5, G 2, G 3, G 7 and subsection I;
2. The annual complaint reports;
3. The MCHIP's formal written evaluations of its quality assurance program expectations for the time period since the MCHIP's last application for a certificate of quality assurance;
4. A copy of the most recent accreditation report executive summary, as applicable, issued to the MCHIP or to the licensee from a nationally recognized accrediting body that evaluates quality assurance programs if the report was issued after the issuance of the current certificate from the department, provided that resubmission of the most recent accreditation report previously submitted in the prior initial or renewal application shall not be required, unless there has been a completed accreditation survey since that time that has led to renewal, suspension, or denial of accreditation and the written corrective action plan in response to the report, if applicable, shall also be submitted;
5. For MCHIP licensees that have been cited by another state or the District of Columbia concerning the quality of health care provided or administered, a copy of the most recent report of an examination of the quality of health care provided by the MCHIP under similar laws and regulations of another state or the District of Columbia, and a copy of the written corrective action response; and
6. A copy of the report of any examination of the MCHIP by a federal regulatory body with similar laws and regulations issued since the certificate of quality assurance was last issued or renewed, provided that submission of this report shall not be necessary if the MCHIP licensee submits a copy of the report required by subdivision 4 of this subsection.
C. In addition, the department shall consider the following in its renewal examination:
1. The report of any comprehensive onsite examination of the MCHIP or licensee if one was conducted during the renewal period; and
2. Any disciplinary actions or sanctions issued by the department pursuant to § 32.1-137.5 of the Code of Virginia or this chapter, or by the Bureau of Insurance in keeping with § 32.1-137.2 E of the Code of Virginia.
D. The department may consider a summary report of the analysis of any data required to be reported by state law or regulation to the Health Care Data Reporting System in its renewal examination.
Statutory Authority
§ 32.1-137.1 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.
12VAC5-408-90. Comprehensive onsite examination.
A. The comprehensive onsite examination represents a periodic quality assurance evaluation process designed to ensure that the MCHIP licensee has in place the appropriate systems and processes to meet the requirements set forth in this chapter.
B. A comprehensive onsite examination shall be conducted triennially except for MCHIPs that meet the criteria specified in 12VAC5-408-100 pertaining to nationally recognized accreditation.
C. The comprehensive onsite examination shall take place:
1. At a time established by the department with 90 days advance notification to the MCHIP licensee;
2. In conjunction with a Bureau of Insurance market conduct examination of the licensee; or
3. At the request of the MCHIP licensee in agreement with the department following the completion of an initial administrative review examination for certification in order to document any corrective action taken in response to the initial examination.
At the department's discretion and in response to complaints against the MCHIP licensee or the MCHIP, the department may expand a complaint investigation to a comprehensive examination to determine compliance with the MCHIP laws and regulations if it appears that covered person's health and safety may be jeopardized.
D. The MCHIP licensee shall be notified in writing at least 90 days in advance of the comprehensive onsite examination and shall be provided with information regarding the parameters of the examination.
The final determination of when a comprehensive onsite examination shall be conducted rests with the department. However, the department will take into consideration mitigating circumstances presented by the MCHIP licensee.
E. The MCHIP licensee or the department may request a preexamination conference for the purpose of discussing preparations for the examination. The conference shall not be used for determining whether a plan needs to be examined or the frequency of an onsite comprehensive examination.
F. Prior to the comprehensive onsite examination, the MCHIP licensee shall make available to the department the results of a member satisfaction survey or other initiative conducted to obtain member input regarding the MCHIP licensee. If the MCHIP licensee did not conduct a member satisfaction survey or initiative, then the MCHIP licensee will publish public notice soliciting comments from the MCHIP's covered persons regarding satisfaction with the MCHIP.
G. The MCHIP shall be notified of the results of the comprehensive onsite examination within 60 business days of the final day of the examination. The department may choose to notify the MCHIP earlier than 60 days and require immediate corrective action or initiate administrative disciplinary hearings for findings of serious or substantial noncompliance with the law or the regulations that could jeopardize covered persons' health or safety.
H. Depending on the examination findings, the department shall:
1. Require a corrective action plan as specified in 12VAC5-408-110 with a time frame in which corrective action shall be completed and verified by the department;
2. Proceed with disciplinary action or sanctions as specified in 12VAC5-408-140; or
3. Notify the MCHIP licensee that it is fully and completely in compliance with all applicable regulations.
I. If the MCHIP licensee applicant has achieved accreditation from a nationally recognized accreditation entity acceptable to the department, it will be exempt from the comprehensive on-site examination following receipt of all accreditation findings.
Statutory Authority
§ 32.1-137.1 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.
12VAC5-408-100. Examination by a nationally recognized accreditation organization.
A. The department shall accept the accreditation of an MCHIP licensee or MCHIP by a nationally recognized accrediting body appropriate to the type of MCHIP and approved by the department in lieu of the triennial comprehensive onsite examination described in 12VAC5-408-90 under the following conditions:
1. Conditional or provisional accreditation may be considered acceptable for meeting the requirements of this chapter provided that a second examination by a nationally recognized accrediting body is scheduled and completed within 15 to 18 months of the date a decision for conditional or provisional accreditation is made by the accrediting body, and that the second examination leads to an accreditation status that is not conditional or provisional.
2. The MCHIP licensee shall release to the department a copy of a report or document from a nationally recognized accrediting body containing that body's final report, or evaluation of the MCHIP's compliance with accreditation standards. The department may, at its discretion and on a case-by-case basis, request from the licensee any and all reports, letters and memoranda issued by the nationally recognized accrediting body to the licensee regarding the licensee's accreditation application or its evaluation for accreditation. In the event a licensee is granted only conditional or provisional accreditation, any written materials generated by the licensee regarding corrective or remedial action to be taken for achieving compliance with the accreditation standards shall also be released to the department at the same time the nationally recognized accrediting body is notified. The MCHIP licensee shall forward copies of the executive summary of its accreditation report to the department within 10 days of receipt by the MCHIP licensee, unless otherwise directed by the department.
3. The MCHIP licensee notifies the department of the date of its accreditation examination.
The department reserves the right to conduct a comprehensive examination of an accredited MCHIP when it appears that the health and safety of the covered persons may be jeopardized.
B. Accreditation by a nationally recognized accrediting body will not be accepted in lieu of the comprehensive onsite examination unless the accreditation standards are appropriate for the type of plan seeking exemption from the department's comprehensive onsite examination.
Statutory Authority
§ 32.1-137.1 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.
12VAC5-408-110. Corrective action procedures.
A. Within 30 business days of the conclusion of the examination, the department shall provide the MCHIP licensee with a written summary of violations of the regulations or laws and any factual findings used as a basis to determine that a violation has occurred.
B. The department shall require the MCHIP licensee to submit a written plan of correction specifying how each violation will be corrected along with the time frames for completion of each corrective action. A single plan of correction shall address all events associated with a given violation. The plan of correction, when required, shall be submitted by the MCHIP licensee within 20 business days of receipt of the notice of violation, or sooner, if the department determines that the violations jeopardize the safety of covered persons.
C. The plan of correction shall be approved when the MCHIP licensee demonstrates to the satisfaction of the department that compliance will be achieved. If the plan of correction is not approved, the department may request that an amended plan of correction be submitted within 10 business days, or sooner, if the department determines that the violations jeopardize the safety of covered persons.
D. The summary of violations and the plan of correction shall not be released as public information until the department has approved the plan of correction or, in the event no plan of correction is required, after 20 business days of receipt of the summary of violations by the MCHIP licensee, whichever is sooner.
E. Unless otherwise documented, the department will presume receipt of the summary of violations by the MCHIP licensee by the seventh business day when mailed return receipt requested.
F. Failure of the MCHIP licensee to successfully implement the written plan of correction within a specified time period may result in an administrative sanction.
Statutory Authority
§ 32.1-137.1 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.
12VAC5-408-120. Changes to geographic service areas.
A. No MCHIP shall operate in a manner that varies in a material manner with the geographic service area information submitted pursuant to this chapter. Any changes in such information which would result in operational changes that vary in a material manner with the information currently on file with the department shall be subject to the department's prior approval.
B. The request for a material change in a geographic service area shall include:
1. A description of the current geographic service area including a map of the current service area, a list of current primary care and specialty physicians and other providers, and the number of covered persons by service area.
2. An explanation as to whether the MCHIP is requesting an expansion or a reduction in its service area.
3. Notification that the MCHIP licensee has inquired of the Bureau of Insurance as to whether or not the service area request constitutes a material change and the bureau's determination, if available.
4. If a service area expansion is proposed, then the following is required:
a. A description of the service area that includes a map of the geographic service area expansion, projections of new enrollment, a listing of new primary care and specialty providers and other providers and their locations, and physician capacity to accept the anticipated enrollment;
b. Information necessary to determine if the MCHIP licensee will be capable of conforming to the access, availability, and travel requirements of 12VAC5-408-260 and 12VAC5-408-270; and
c. The methodology used to determine that the current health care system in the proposed service area can support the expansion.
5. If an MCHIP is reducing or eliminating a service area, the following information is required:
a. A description of the service area being reduced or eliminated;
b. The reason for the reduction or elimination of the service area and the effective date on which health care services will no longer be available through the MCHIP; and
c. Any information required by the department to determine that MCHIP covered persons are ensured continuity of care during the transition.
C. If the department fails to act on a notice of material change within 30 days of receipt of filing all necessary information, the proposed changes shall be deemed approved. The department, at its discretion, may extend the period of time within which to approve or disapprove the proposed changes for up to an additional 30 days. Licensees shall be notified in writing of any such extensions.
Statutory Authority
§ 32.1-137.1 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.
12VAC5-408-130. Complaint system, complaint examination and investigation.
A. Each MCHIP licensee shall establish and maintain for each of its MCHIPs a complaint system approved by the department and the Bureau of Insurance to provide reasonable procedures for the resolution of complaints.
B. The department, on behalf of the commissioner and in cooperation with the Bureau of Insurance, shall examine the complaint system for compliance of the system with applicable statutes and regulations and shall require corrections or modifications as necessary. The effectiveness of the complaint system in allowing covered persons, or their duly authorized representatives, to have issues regarding quality assurance appropriately resolved shall be assessed by the department.
C. The department has the responsibility to investigate complaints regarding quality of care violations filed by or on behalf of covered persons.
D. Every person from whom information is sought in an investigation of a complaint against an MCHIP licensee shall cooperate in producing, or allowing reasonable access during regular business hours to, the books, records, files, accounts, papers, documents, and any or all computer or other recordings of the licensee being examined or those of any person or delegated services entity delivering health care services under contract, affiliation, delegation or other arrangement. Information shall be limited to that which is relevant to the investigation in question.
E. Deficiencies found during a complaint investigation shall be corrected as required in 12VAC5-408-110.
F. When the investigation is complete, the MCHIP licensee and the complainant will be notified of the findings of the investigation.
Statutory Authority
§ 32.1-137.1 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.
12VAC5-408-140. Administrative sanctions.
A. Nothing in this part shall prohibit the department from exercising its responsibility and authority to enforce applicable law and this chapter including proceeding directly to imposition of administrative sanctions.
B. The department, in consultation with the Bureau of Insurance, may impose such administrative sanctions or take such actions as are appropriate for violation of any of the regulations or laws. Such sanctions include:
1. Imposing civil monetary penalties, which shall not exceed $1,000 per incident of noncompliance, to a maximum of $10,000 for a series of related incidents of noncompliance;
2. Placing a certificate holder on probation;
3. Temporarily suspending a certificate of quality assurance;
4. Temporarily restricting or prohibiting, with the concurrence of the Bureau of Insurance, new enrollments into an MCHIP;
5. Revoking or not renewing a certificate of quality assurance and certifying to the Bureau of Insurance that an MCHIP licensee or its managed care health insurance plan is unable to fulfill its obligations to furnish quality health care services; or
6. Other remedies as provided by state or federal law.
C. The MCHIP licensee shall receive a written notice describing the reasons for the imposition of sanctions and a report specifying the findings of noncompliance. Upon receipt of the notice to impose a sanction, the MCHIP licensee shall have the right and the opportunity to appeal the sanction according to § 32.1-137.5 of the Code of Virginia. A copy of the department's notice shall be provided to the Bureau of Insurance.
Statutory Authority
§ 32.1-137.1 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.
12VAC5-408-150. Surrender of certificate.
A. Upon revocation or suspension of a certificate or loss of license, the MCHIP licensee must surrender its certificate to a representative of the center.
B. In the event an MCHIP licensee voluntarily ceases operation, it shall provide at least 90 business days advance written notice to all covered persons, employers, providers, the department, and the Bureau of Insurance. The notice shall identify the storage location of business and medical records, where applicable, and procedures for obtaining copies of such records.
Statutory Authority
§ 32.1-137.1 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.