Part I. Miscellaneous Provisions
12VAC30-20-10. Attorney General's certification.
I certify that The Department of Medical Assistance Services is the single state agency responsible for: administering the plan.
The legal authority under which the agency administers the plan on a Statewide basis is Title 32.1, Chapter 10 Section 32.1-325, Code of Virginia (1950) as amended.
Date: Feb 14, 1985
Signature: /s/Gerald L. Baliles, Attorney General
Statutory Authority
Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
Historical Notes
Derived from VR460-02-1.1100, eff. March 1, 1985.
12VAC30-20-20. (Repealed.)
Historical Notes
Derived from VR460-02-1.2100 through VR460-02-1.2400, eff. March 1, 1985; repealed, Virginia Register Volume 12, Issue 2, eff. November 15, 1995.
12VAC30-20-60. Definition of Medicaid state plan health maintenance organizations (HMOs).
A. Definitions. A Virginia Medicaid qualifying health maintenance organization (HMO) is defined as an entity which has a license to operate as a health maintenance organization issued by the Bureau of Insurance of the State Corporation Commission.
B. Incorporation by reference. The Bureau of Insurance of the State Corporation Commission, through Insurance Regulation No. 28, Rules Governing Health Maintenance Organizations, effective September 1, 1987, provides licensing only to health maintenance organizations meeting the requirements of 43 CFR 434.20(c). The Department of Medical Assistance Services hereby incorporates by reference Insurance Regulation No. 28.
C. Organization and description. Virginia Medicaid qualifying health maintenance organizations shall be primarily organized for the purpose of providing health care services. As provided for in Regulation 28, a health maintenance organization is an organization which undertakes to provide or arrange for one or more health care plans. A health care plan is any arrangement in which any health maintenance organization undertakes to provide, arrange for, pay for, or reimburse any part of the cost of any health care services.
D. Accessibility of services. Virginia Medicaid qualifying health maintenance organizations shall make the services they provide as accessible to Medicaid enrollees as those services are available to non-enrolled Medicaid recipients within the area served by the Virginia Medicaid qualifying health maintenance organization. As provided for in Regulation 28, all Virginia Medicaid qualifying health maintenance organizations must establish and maintain arrangements satisfactory to the Medicaid Agency to assure both availability and accessibility of personnel and facilities providing health care services including:
1. Reasonable hours of operation and after-hours emergency health care,
2. Reasonable proximity to enrollees within the service area, so as not to result in unreasonable barriers to accessibility,
3. Sufficient personnel, including health professionals, administrators, and support staff, to reasonably assure that all services contracted for will be accessible to enrollees on an appropriate basis without delays detrimental to the health of the enrollee, and
4. Adequate arrangements to provide inpatient hospital services for basic health care.
E. Financial requirements. Regulation 28 provides controls limiting the risk of insolvency of Virginia Medicaid qualifying health maintenance organizations, and assuring that Medicaid enrollees will not be liable for any Virginia Medicaid qualifying health maintenance organization's debts should it become insolvent. Specifically, Regulation 28 sets forth the requirements for a Virginia Medicaid qualifying health maintenance organization's minimum net worth, deposits with the State Treasurer, mandated liability insurance, enrollee hold harmless provisions in subcontracts, and accounting and reporting responsibilities.
F. The Medicaid Agency shall, through the terms and conditions of risk contracts with Virginia Medicaid qualifying health maintenance organizations, make provisions for meeting the additional requirements provided for in 42 CFR 434.
Statutory Authority
§ 32.1-325 of the Code of Virginia.
Historical Notes
Derived from VR460-02-2.1100, eff. July 1, 1995.
12VAC30-20-70. (Repealed.)
Historical Notes
Derived from VR460-02-2.8100, eff. December 18, 1991; repealed, Virginia Register Volume 11, Issue 24, eff. September 21, 1995.
12VAC30-20-80. Coordination of Title XIX with Part A and Part B of Title XVIII.
The following method is used to provide benefits under Part A and Part B of Title XVIII to the groups of Medicare-eligible individuals indicated:
A. Part B buy-in agreements with the Secretary of HHS. This agreement covers:
1. All individuals eligible under the state's approved Title XIX plan except qualified disabled working individuals.
2. Qualified Medicare beneficiaries provided by § 301 of P.L. 100-360 as amended by § 8434 of P.L. 100-647.
3. Specified low-income Medicare beneficiary (SLMB) provided by § 1905(p) of the Act.
4. Qualifying Individuals-1: The Medicaid agency pays Medicare Part B premiums under the State buy-in process for individuals described in § 1902(a)(10)(E)(iv)(I) and subject to § 1933 of the Act.
B. Part A group premium payment arrangement entered into with the Social Security Administration. This arrangement covers the following groups: Qualified Disabled & Working Individuals provided by § 6408 of OBRA 1989 and Qualified Medicare beneficiaries provided by § 301 of P.L. 100-360 as amended by § 8434 of P.L. 100-647.
C. Payment of Part A and Part B deductible and coinsurance cost. Such payments are made in behalf of the following groups:
1. All individuals eligible for Title XVIII covered services.
2. Qualified Medicare beneficiaries provided by § 301 of P.L. 100-360 as amended by § 8434 of P.L. 100-647.
Statutory Authority
§§ 32.1-324 and 32.1-325 of the Code of Virginia.
Historical Notes
Derived from VR460-02-3.2100, eff. January 1, 1991; amended, Virginia Register Volume 17, Issue 13, eff. April 11, 2001; Volume 19, Issue 18, eff. July 1, 2003.
12VAC30-20-90. Confidentiality and disclosure of information concerning Medicaid applicants and recipients.
A. Definitions. The following words and terms when used in these regulations shall have the following meanings, unless the context clearly indicates otherwise:
"Agency" or "the Medicaid agency" means the Department of Medical Assistance Services or its designee.
"Client" means an applicant for, or recipient of, Medicaid benefits.
"Client information" or "client record" means any information, including information stored in computer data banks or computer files relating to a recipient or applicant, which was received in connection with the performance of any function of the agency and which either identifies a client or describes a client such that the client could be specifically identified.
"Provider" means any individual or organization that delivers a medical service to a recipient of, or applicant for, Medicaid benefits.
"The Plan" means the State Plan for Medical Assistance.
B. Purpose. Section 1902(a)(7) of the Social Security Act and 42 CFR 431.300 et seq. require a State Plan for Medical Assistance to provide safeguards to restrict the use or disclosure of information concerning applicants and recipients to purposes directly connected with the administration of the Plan. The rules herein are established to protect the rights of clients to confidentiality of their Medicaid information. Section 32.1-325.3 of the Code of Virginia requires the Board of Medical Assistance Services to promulgate regulations consistent with the foregoing.
C. Release of client information. Except as otherwise provided in these rules, no person shall obtain, disclose or use, or authorize, permit or acquiesce the use of any client information that is directly or indirectly derived from the records, files, or communications of the agency, except for purposes directly connected with the administration of the Plan or as otherwise provided by federal and state law. The agency can conduct all of the above administrative activities itself or it can contract some or all of them to other state agencies or private companies. These other entities must maintain client information confidential in accordance with the terms of these regulations. Purposes directly related to the administration of the Plan include; but are not limited to:
1. Establishing eligibility;
2. Determining the amount of medical assistance;
3. Providing services for recipients; and
4. Conducting or assisting in an investigation, prosecution or a civil or criminal proceeding related to the administration of the Plan.
D. Safeguarding client information. All information associated with an applicant or recipient that could disclose the individual's identity is confidential and shall be safeguarded. Such information shall include, but is not limited to:
1. Name, address and all types of identification numbers assigned to the client;
2. Medical services provided to the client;
3. Social and economic conditions or circumstances of the client;
4. Agency evaluation of the client's personal information;
5. Medical data about the client, including diagnoses and past histories of disease or disabilities;
6. Information received for verifying income, eligibility, and amount of medical assistance payments; and
7. Information received in connection with identification of legally liable third party resources, and information received in connection with processing and rendering decisions of recipient appeals.
E. Ownership of records.
1. All client information contained in the agency records is the property of the agency, and employees of the agency shall protect and preserve such information from dissemination except as provided herein.
2. Original client records are not to be removed from the premises by individuals other than authorized staff of the agency, except by a court order. The agency may destroy records pursuant to records retention schedules consistent with state and federal regulations.
F. Disclosure of client information.
1. Conditions for releasing information. Access to information concerning applicants or recipients must be restricted to persons or agency representatives who are subject to the standards of confidentiality that are consistent with that of the agency.
a. Consent. As part of the application process for Medicaid, the client shall be informed of the need to consent to the release of information necessary for verifying eligibility. Whenever a person, agency or organization that is not performing one or more of the functions delineated in subsection C of this section requests client information, the Medicaid agency must obtain written permission to disseminate the information from the client or the person legally responsible for the client whenever possible. A release for information obtained from the client by the requesting agency also satisfies this requirement.
b. Client information may be released without the client's written permission under the following conditions:
(1) An emergency exists and prior attempts to contact the client or legally responsible persons for permission have been unsuccessful;
(2) A court of competent jurisdiction has ordered the production of information and the agency does not have sufficient time to notify the client or legally responsible person before responding to the order;
(3) The release of such client information is necessary to prevent loss of, or risk to, life or health of the client;
(4) In the case of third party liability, as explained in subdivision G 2 of this section; or
(5) Release is not otherwise prohibited by law or regulation.
c. Notification. If one of the conditions above is met and consent is not obtained before the release of the information, the agency must provide written notification to the client or legally responsible person within five work days after disclosure.
d. Consent process. The consent for release of information shall contain the following:
(1) The name of the agency or entity supplying the information and the name of the requesting party;
(2) A description of the information to be released;
(3) A statement that the consent is limited to the purpose designated;
(4) The length of time the consent is valid; and
(5) The consent must be signed and dated by the client. The client may add other information which may include, but is not limited to, a statement specifying the date, event or condition upon which the consent expires.
G. Information exchanges.
1. Governmental agencies.
a. Confidential information can be released to other governmental agencies without the consent of the client for purposes of complying with state or federal statutes or regulations pursuant to written data exchange agreements. Such agreements will (i) specify the information to be exchanged; (ii) the titles of all agency officials with the authority to request income and eligibility information; (iii) the methods, including the formats to be used, and the timing for requesting and providing the information; (iv) the safeguards limiting the use and disclosure of the information as required by federal or state law or regulations; (v) the method, if any, the agency will use to reimburse reasonable costs of furnishing the information; and (vi) in the case of an agreement between a SWICA or a UC agency and the Medicaid agency, that the Medicaid agency will obtain information on applicants at least twice monthly. Such information exchanged by governmental agencies is made available only to the extent necessary to assist in the valid administrative needs of the governmental agency receiving the information and adequate safeguards shall be maintained to protect the information from further disclosure. Information received under § 6103(1) of the Internal Revenue Code of 1954 is exchanged only with agencies or delegated entities authorized to receive such information.
b. Medical assistance information contained in the records of the local departments of social services may be disclosed for purposes directly connected with the Medicaid program to providers of services enrolled in the Medical Assistance Program for the purpose of verifying a client's status as a Medicaid recipient.
2. Information exchanged in third party liability cases. Client information may be disclosed without consent in the recovery of monies for which third parties are liable for payment of claims. All such third parties shall be notified of the rules for safeguarding client information. The notification shall incorporate a written statement which advises third parties of the Medicaid program's client confidentiality regulations, specifies that clients' names, addresses and medical services data are confidential, must only be used in the administration of the Medicaid program and must not be released to any other person or entity in a manner inconsistent with the governing regulations. The notice shall further include the following statement. "Any willful violation of the governing regulations constitutes a Class 1 misdemeanor and may be punishable accordingly."
H. Client's right of access to information.
1. Client's right to access. Any client has the right to obtain personal information held by the agency or its representative. Upon written or verbal request, the client shall be permitted to review or obtain a copy of the information in his record with the following exceptions:
a. Information that the agency is required to keep confidential from the client pursuant to subdivision 1 of § 2.2-3705.5 of the Code of Virginia, or any other applicable law; or;
b. Information that would breach another individual's right to confidentiality.
2. Process for disclosure. Consistent with the Virginia Freedom of Information Act, § 2.2-3704, Code of Virginia, the agency shall provide access within five work days after the receipt of the request. The agency shall make disclosures to applicants and recipients during normal business hours. Copies of the requested documents shall be provided to the client or a representative at reasonable standard charges for document search and duplication.
3. Types of information available for client access. The client shall be permitted to be accompanied by a person or persons of the client's choice and may grant permission verbally or in writing to the agency to discuss the client's file in such person's presence. Upon request and proper identification of any client or agent of the client, the agency shall grant to the client or agent the right to review the following:
a. All personal information about the client except as provided in subdivision 1 of § 2.2-3705.5 of the Code of Virginia; and
b. The identity of all individuals and organizations not having regular access authority that request access to the client's personal information.
4. Contested information. Pursuant to § 2.2-3806 of the Government Data Collection and Dissemination Practices Act, a client may contest the accuracy, completeness or relevancy of the information in his record. Correction of the contested information, but not the deletion of the original information if it is required to support receipt of state or federal financial participation, shall be inserted in the record when the agency concurs that such correction is justified. When the agency does not concur, the client shall be allowed to enter a statement in the record refuting such information. Corrections and statements shall be made a permanent part of the record and shall be disclosed to any person or entity that receives the disputed information.
I. Distribution of information to applicants and recipients. All materials distributed to applicants, recipients, or medical providers must directly relate to the administration of the Medicaid program and have no political implications. The agency must not distribute materials such as holiday greetings, general public announcements, voting information, or alien registration notices. The agency may distribute materials directly related to the health and welfare of applicants and recipients, such as announcements of free medical examinations, availability of surplus food and consumer protection information.
J. Publicizing safeguarding requirements. The agency shall inform clients in writing as follows:
Personal information regarding applicants for or recipients of Medicaid must be maintained confidential pursuant to state and federal law. Consistent with §§ 32.1-325.4 and 18.2-11 of the Code of Virginia, any violation of state regulations governing applicant or recipient confidentiality is punishable by up to 12 months in jail and a $2,500 fine.
Statutory Authority
§§ 32.1-324 and 32.1-325 of the Code of Virginia.
Historical Notes
Derived from VR460-02-4.3100, eff. February 26, 1992; amended, Virginia Register Volume 25, Issue 14, eff. April 15, 2009.
12VAC30-20-100. Standards governing general and special hospitals and convalescent and nursing homes.
The Code of Virginia, Title 32, authorizes the State Board of Health to adopt and promulgate reasonable rules and regulations as to standards of health to be maintained and such other matters as will promote the safety and insure proper attention and service to and care of patients and inmates of private or public hospitals and institutions.
Rules and Regulations Governing General and Special Hospitals and Convalescent and Nursing Homes in Virginia are published by the Virginia Department of Health under the above legal authority. Only facilities which meet the standards and requirements of these Rules and Regulations are licensed for operation within the Commonwealth of Virginia. Compliance is evaluated from scheduled and non-scheduled personal visits to each facility by a highly qualified specially designated staff element (Bureau of Medical and Nursing Facilities) Division of Licensure Certification of the Department of Health. Rules and Regulations are available for review upon request.
Intermediate care facilities in mental institutions are licensed by the State Department of Mental Health and Mental Retardation as a condition for certification as an ICF facility by the Department of Health's Bureau of Medical and Nursing Facilities.
Mental Hospitals and Institutions for Mentally Retarded, which render hospital or skilled nursing home services, are licensed by the State Department of Mental Health and Mental Retardation and are certified for the Title XVIII Program by the Department of Health's Bureau of Medical and Nursing Facilities.
Descriptions of standards utilized for licensing and certifying these institutions, published in official, bound form are available for review upon request.
Statutory Authority
Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
Historical Notes
Derived from VR460-02-4.1110, eff. December 20, 1973.
12VAC30-20-110. Nursing facility resident drug utilization review.
1. Definitions. The following words and terms, when used in this regulation, shall have the following meanings unless the context clearly indicates otherwise:
"DMAS" means the Department of Medical Assistance Services consistent with the Code of Virginia, Chapter 10, Title 32.1, §§ 32.1-323 et seq.
"Drug utilization review" means a formal continuing program for assessing medical and/or drug use data against explicit standards and, as necessary, introducing remedial strategies.
"Drug Utilization Review Committee (DUR Committee)" means a committee composed of knowledgeable health care professionals who make recommendations for developing and modifying drug therapy review standards or criteria, participate in retrospective reviews, recommend remedial strategies, and evaluate the success of the interventions.
"Exceptional drug utilization pattern" means 1) a pattern of drug utilization within a nursing facility that differs substantially from predetermined standards established pursuant to § 3(B); 2) individual resident's drug use patterns that differ from the established standards; or 3) individual resident's drug use patterns that exhibit a high risk for drug therapy induced illness.
"Retrospective drug review" means the drug utilization review process that is conducted using historic or archived medical and/or drug use data.
"Targeted facility" means a nursing facility where residents' patterns of drug utilization demonstrate an exceptional drug utilization pattern as defined herein.
2. Scope
A. Medicaid shall conduct a drug utilization review program for covered drugs prescribed for nursing facility residents. The program shall help to ensure that prescriptions are appropriate, medically necessary, and are not likely to cause adverse actions. The primary objectives are 1) improvement in the quality of care; 2) conserving program funds and individual expenditures; and 3) maintaining program integrity (i.e., controlling problems of fraud and benefit abuse).
B. Retrospective drug utilization review will be conducted on an ongoing basis in targeted nursing facilities demonstrating exceptional drug utilization patterns.
C. With the aim of improving prescribing practices, the program shall provide for ongoing educational outreach programs to educate practitioners on common drug therapy problems.
3. Utilization Review Process
A. The program shall provide, through its drug claims processing and information retrieval systems, for the ongoing periodic examination of claims data and other records for targeted facilities to identify patterns of inappropriate or medically unnecessary care for individuals receiving benefits under Title XIX of the Social Security Act.
B. The program shall, on an ongoing basis, assess data on drug use against predetermined standards (as described in this section) including, but not limited to, monitoring for therapeutic appropriateness, overutilization and underutilization, appropriate use of generic products, therapeutic duplication, drug-disease contraindications, drug/drug interactions, incorrect drug dosage or duration of treatment, clinical abuse/misuse, fraud, and, as necessary, introduce to physicians and pharmacists remedial strategies in order to improve the quality of care.
C. The Department of Medical Assistance Services may assess data on drug use against such standards as the American Hospital Formulary Service Drug Information (1995, as amended), United States Pharmacopeia-Drug Information (1995, as amended), American Medical Association Drug Evaluations (1993, as amended), and peer-reviewed medical literature.
4. Drug Use Review Committee
A. DMAS shall provide for the establishment of a drug use review committee (hereinafter referred to as the "DUR Committee"). The Director of DMAS shall determine the number of members and appoint the members of the DUR committee.
B. The membership of the DUR Committee shall include health care professionals who have recognized knowledge and expertise in one or more of the following areas:
1. The clinically appropriate prescribing of covered drugs;
2. The clinically appropriate dispensing and monitoring of covered drugs;
3. Drug use review, evaluation, and intervention; and
4. Medical quality assurance;
5. Clinical practice and drug therapy in the long term care setting.
C. The membership of the DUR Committee shall include physicians, pharmacists, and other health care professionals, including those with recognized expertise and knowledge in long term care.
D. Activities of the DUR Committee shall include, but not be limited to, the following:
1. Retrospective drug utilization review as defined in § 2 (B) of this regulation;
2. Application of standards as defined in § 3 (C) of this regulation; and
3. Ongoing interventions for physicians and pharmacists, targeted toward therapy problems of individuals identified in the course of retrospective drug use reviews.
E. The DUR Committee shall re-evaluate interventions after an appropriate period of time to determine if the intervention improved the quality of drug therapy, to evaluate the success of the interventions and recommend modifications as necessary.
5. Medical Quality Assurance
A. Documentation of drug regimens in nursing facilities shall, at a minimum:
1. Be included in a plan of care that must be established and periodically reviewed by a physician;
2. Indicate all drugs administered to the resident in accordance with the plan with specific attention to frequency, quantity, and type and identify who administered the drug (include full name and title); and
3. Include the drug regimen review prescribed for nursing facilities in regulations implementing 42 CFR 483.6.
B. Documentation specified in paragraph A will serve as the basis for drug utilization reviews provided for in these regulations.
Statutory Authority
Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
Historical Notes
Derived from VR460-02-4.1470, eff. October 1, 1991.
12VAC30-20-120. Cooperative arrangements with the state vocational rehabilitation agency and with Title V programs and grantees.
As the Single State Agency, the Department of Medical Assistance Services promulgated agreements with the following State agencies/activities concerning services rendered to Medical Assistance program eligible recipients.
1. Agreement with the Department of Social Services concerning responsibilities of that Department for (a) determination of eligibility, (b) provision of social services, (c) activity associated with fair hearings, (d) fraud, (e) quality control, (f) non-discrimination, (g) staffing, (h) staff development and recruiting, (i) maintenance of records, (j) review of local operations and (k) exchange of information (6-29-89, as amended).
2. Agreement with the Department of Vocational Rehabilitation concerning responsibilities of that Department for providing rehabilitation services necessary to render disabled individuals to attain a state of health which will permit them to engage in gainful employment and for providing liaison personnel to assist the State Agency in screening referrals for rehabilitation services (4-30-93, as amended).
3. Agreements with Department of Health programs for Maternal, Child Health, Family Planning and Crippled Children and for grantee project activities operated under these programs concerning provision of medical and social services to eligible recipients and reimbursements to be made for rendering covered services (3-12-93, as amended).
4. Agreements with Special Projects operating in this State under Federal grant funding procedures and which provide medical or dental services covered by the Medical Assistance Program concerning types and limits of services and reimbursement for services rendered.
Statutory Authority
Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
Historical Notes
Derived from VR460-02-4.1610, eff. July 1, 1985.