Administrative Code

Virginia Administrative Code
8/8/2022

Part IV. Drug Utilization Review Program

12VAC30-130-270. Definitions.

The following words and terms when used in this part shall have the following meanings unless the context clearly indicates otherwise:

"Abuse" means (i) use of health services by recipients which is inconsistent with sound fiscal or medical practices and that results in unnecessary costs to the Virginia Medicaid program or in reimbursement for a level of use or a pattern of services that is not medically necessary, or (ii) provider practices which are inconsistent with sound fiscal or medical practices and that result in (a) unnecessary costs to the Virginia Medicaid program, or (b) reimbursement for a level of use or a pattern of services that is not medically necessary or that fails to meet professionally recognized standards for health care.

"Appropriate and medically necessary" means drug prescribing and dispensing practices which conform with the criteria and standards developed pursuant to this regulation and are consistent with the diagnosis or treatment of an identified condition.

"Criteria and standards" means predetermined objective tests established by or approved by the Drug Utilization Review Board for use in both retrospective and prospective screening of the quality and appropriateness of pharmacy services for Medicaid recipients. Objective tests shall include both criteria, which are based upon professional expertise, prior experience, and the professional literature with which the quality, medical necessity, and appropriateness of health care services may be compared, and standards, which are professionally developed expressions of the range of acceptable variation from a criterion.

"Code" means the Code of Virginia.

"DMAS" means the Department of Medical Assistance Services consistent with Chapter 10 (§ 32.1-323 et seq.) of Title 32.1 of the Code of Virginia.

"Director" means the Director of DMAS.

"Drug Utilization Review (DUR)" means a formal continuing program for assessing medical and recipients' drug utilization data against explicit standards and criteria and, as necessary, introducing remedial strategies.

"Drug Utilization Review Board (DUR Board)" means the group of health care professionals appointed by the director and established pursuant to § 1927(g)(3) Title XIX of the Social Security Act.

"Drug Utilization Review Committee (DUR Committee)" means a committee composed of 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 a pattern of drug use that differs from the standards and criteria established pursuant to this part.

"Fraud" means any act including intentional deception or misrepresentation that constitutes fraud under applicable federal or state laws.

"OBRA 90" means the Omnibus Budget Reconciliation Act of 1990.

"Patient's agent" means the person or persons selected by the recipient to act on his behalf with regard to the recipient's receipt of Title XIX pharmacy services.

"Patient counseling" means communication of information by the pharmacist, in person whenever practicable, to patients receiving benefits under Title XIX of the Social Security Act or the patient's agent, to improve therapeutic outcomes by encouraging proper use of prescription medications and devices.

"Prospective drug utilization review" means a review by the pharmacist of the prescription medication order and the patient's drug therapy before each prescription is filled. The review shall include an examination of any patient profile (which has been maintained by the pharmacist) to determine the possibility of potential drug therapy problems due to therapeutic duplication, drug-disease contraindications, drug-drug interactions (including serious interactions with nonprescription or over-the-counter drugs, incorrect drug dosage or duration of drug treatment, drug-allergy interactions, and clinical abuse or misuse).

"Restriction" means (i) an administrative limitation imposed by DMAS on a recipient which requires the recipient to obtain access to specific types of health care services only through a designated primary provider or (ii) an administrative limitation imposed on a provider to prohibit participation as a designated primary provider, referral provider, or covering provider for restricted recipients.

"Retrospective drug utilization review" means the drug use review process that is conducted by DMAS using historic or archived medical or drug use data which may include but is not restricted to patient profiles and historical trends.

Statutory Authority

§§ 32.1-324 and 32.1-325 of the Code of Virginia.

Historical Notes

Derived from VR460-04-4.2600 § 1, eff. June 16, 1993; amended, Virginia Register Volume 25, Issue 14, eff. April 15, 2009.

12VAC30-130-280. Authority.

Section 1927 of Title XIX Social Security Act provides the authority for this program.

Statutory Authority

§ 32.1-325 of the Code of Virginia.

Historical Notes

Derived from VR460-04-4.2600 § 2, eff. June 16, 1993.

12VAC30-130-290. Scope and purpose.

A. DMAS shall implement and conduct a drug utilization review program (DUR program) for covered drugs prescribed for eligible recipients. The program shall help to ensure that prescriptions are appropriate, medically necessary, and are not likely to cause medically adverse events. The program shall provide for ongoing retrospective DUR, prospective DUR and an educational outreach program to educate practitioners on common drug therapy problems with the aim of improving prescribing practices. As needed, the program shall also provide for electronic messages as well as rejected or denied services when such claims are not consistent with DUR criteria and requirements. The primary objectives shall be:

1. Improving in the quality of care;

2. Maintaining program integrity (i.e., controlling problems of fraud and benefit abuse); and

3. Conserving program funds and individual expenditures.

B. Certain organized health care settings shall be exempt from the further requirements of retrospective and prospective DUR process as provided for in § 4401 of OBRA 90.

C. The purpose of retrospective DUR shall be to screen for:

1. Monitoring for therapeutic appropriateness;

2. Overutilization and underutilization;

3. Appropriate use of generic products;

4. Therapeutic duplication;

5. Drug-disease/health contraindications;

6. Drug-drug interactions;

7. Incorrect drug dosage or duration of treatment;

8. Clinical abuse/misuse and fraud, and as necessary

9. Introduce to physicians and pharmacists remedial strategies to improve the quality of care rendered to their patients.

D. The purpose of prospective DUR shall be to screen for:

1. Potential drug therapy problems due to therapeutic duplication;

2. Drug-disease/health contraindications;

3. Drug-drug interactions (including serious interactions with nonprescription or over-the-counter drugs);

4. Incorrect drug dosage or duration of drug treatment;

5. Drug-allergy interactions; and

6. Clinical abuse and misuse.

E. In instances where initial claims for reimbursement of covered services are determined to be in conflict with DUR criteria and requirements, such claims shall receive electronic messages or be rejected or denied, as appropriate, back to the dispensing pharmacist with notification as to the substance of the conflict. The dispensing pharmacist will be afforded the opportunity to provide an intervention, based on his professional expertise and knowledge, to modify the service to be claimed for reimbursement. If the modification no longer conflicts with the DUR criteria, the claim for the modified service shall be adjudicated for payment. If the modification requires additional information from the prescriber, the pharmacist shall advise the prescribing physician of the continuing conflict and advise the physician to seek prior authorization approval from either DMAS or the pharmacy benefits contractor for his treatment plans.

F. Designated interventions may include provider override, obtaining prior authorization via communication to a call center staffed with appropriate clinicians, or written communication to prescribers.

Statutory Authority

§§ 32.1-324 and 32.1-325 of the Code of Virginia.

Historical Notes

Derived from VR460-04-4.2600 § 3, eff. June 16, 1993; amended, Virginia Register Volume 21, Issue 6, eff. January 3, 2005; Volume 25, Issue 14, eff. April 15, 2009.

12VAC30-130-300. Retrospective DUR.

A. The retrospective DUR program shall provide, through drug claims processing and information retrieval systems, for ongoing periodic examination of claims data and other records in order to identify patterns of fraud, abuse, overuse, or inappropriate or medically unnecessary care among physicians, pharmacists, and individuals receiving benefits under Title XIX of the Social Security Act.

B. The DUR program shall, on an ongoing basis, assess data on drug use against predetermined criteria and standards which have been approved by the DUR Board.

C. Summary data concerning identified exceptional drug utilization patterns shall be developed and submitted by DMAS to the DUR Board at least quarterly, or as often as monthly if requested by the DUR Board. This data shall include at least a summary of the drug therapy problems most often observed in the course of retrospective reviews, summaries of physician responses to educational interventions, and the results of intensified reviews and monitoring of selected prescribers or dispensers.

Statutory Authority

§ 32.1-325 of the Code of Virginia.

Historical Notes

Derived from VR460-04-4.2600 § 4, eff. June 16, 1993.

12VAC30-130-310. Prospective DUR.

A. Patient medication profile. On and after January 1, 1993, pharmacists shall make a reasonable effort to maintain a patient medication record system for persons covered under Title XIX of the Social Security Act for whom prescriptions are dispensed. For purposes of this regulation, a reasonable effort shall have been made if the information set forth in subdivision 1 of this subsection is requested by the pharmacist or the pharmacist's designee from the patient or the patient's agent.

1. A reasonable effort shall be made by the participating pharmacist to obtain, record, and maintain at least the following information on each patient's profile:

a. Patient's name, address, telephone number;

b. Date of birth (or current age) and gender;

c. Medical history

(1) Significant patient health problems known to the pharmacist,

(2) Prescription drug reactions or known allergies,

(3) A comprehensive list of prescription and nonprescription medications and legend drug administration devices known by the pharmacist to have been used by the patient; and

d. Prescriber information to include, but not necessarily be limited to, name, address, and Medicaid and Drug Enforcement Agency (DEA) provider numbers.

e. Pharmacist's comments relevant to the patient's drug use, including any failure to accept the pharmacist's offer to counsel.

2. Such information may be recorded in any system of records and may be considered by the pharmacist in the exercise of his professional judgment concerning both the offer to counsel and content of counseling. DMAS or its designated agent is authorized to survey pharmacists' patients in order to determine compliance with and report on the mandates of federal and state law and regulations.

3. The information for patient profiles may be obtained from a patient's prescribing physician, hospital medical records, interviews with the patient, patient's family or agent, or a combination of the above.

4. Patient medication profiles shall be maintained for a period of not less than two years from the date of last entry or as necessary to comply with state or federal law.

B. Pharmacist's responsibilities. Upon receipt of each prescription and before dispensing the medication, a pharmacist shall perform prospective DUR based on his professional knowledge and the criteria and standards approved by the DUR Board, using the information contained in the patient's profile.

If an exception to one or more prospective DUR criteria is identified, a message will be transmitted to the pharmacist. Claims may be rejected due to the exceptions to one or more criteria. Pharmacists may be required to obtain prior authorization, defined as the process of reviewing drugs to determine if medically justified prior to the submission of a claim for payment by Medicaid, in order to dispense the medications.

Designated interventions may include provider override, obtaining prior authorization via communication to a call center staffed with appropriate clinicians, or written communication to prescribers.

C. Patient counseling. Consistent with federal law and regulation a pharmacist must offer to discuss in person, whenever practicable, or through access to a telephone service which is toll-free for long-distance calls with each individual receiving benefits or the caregiver of such individual who presents a prescription, matters which in the exercise of the pharmacist's professional judgment are deemed to be significant. The offer to counsel shall be made consistent with the requirements in § 54.1-3319 B of the Code of Virginia.

The specific areas of counseling shall include those matters listed below that, in the exercise of his professional judgment, the pharmacist considers significant:

1. Name and description of the medication;

2. Dosage form and amount, route of administration, and duration of therapy;

3. Special directions for preparation, administration and use by the patient as deemed necessary by the pharmacist;

4. Common or severe side or adverse effects or interactions that may be encountered which may interfere with the proper use of the medication as was intended by the prescriber, and the action required if they occur;

5. Techniques for self-monitoring drug therapy;

6. Proper storage;

7. Prescription refill information;

8. Action to be taken in the event of a missed dose.

9. Any other matters the pharmacist considers significant.

Alternative forms of patient information may be used to supplement, but not replace, oral patient counseling.

A pharmacist shall not be required to provide oral consultation when a patient or a patient's agent refuses the pharmacist's attempt to consult.

When prescriptions are delivered to the patient or patient's agent who resides outside of the local telephone calling area of the pharmacy, the pharmacist shall either provide a toll free telephone number or accept collect calls from such patient or patient's agent.

Patient counseling as described in this part shall not be required for inpatients of a hospital or institution where a nurse or other person authorized by the Commonwealth is administering the medication.

D. Compliance monitoring. An ongoing program shall be developed for the purpose of monitoring pharmacists' compliance with the prospective DUR requirements of this part.

The director may establish the compliance monitoring program through agreements with other state agencies, the DUR Board or other organizations.

As determined to be appropriate by DMAS, the methods used to monitor compliance shall include but shall not be limited to:

1. On-site inspections,

2. Patient surveys,

3. Desk audits, or

4. Retrospective pharmacy profile reviews.

5. Electronic messages as well as rejection or denial of claims until there is resolution of the conflict with DUR criteria.

Statutory Authority

§§ 32.1-324 and 32.1-325 of the Code of Virginia.

Historical Notes

Derived from VR460-04-4.2600 § 5, eff. June 16, 1993; amended, Virginia Register Volume 21, Issue 6, eff. January 3, 2005.

12VAC30-130-320. Criteria and standards for DUR.

The DUR Board shall establish and revise as necessary a list of approved criteria and standards which shall be consistent with the following:

1. Compendia which shall consist of at least the publications, as may be amended from time to time, that are referenced at 12VAC30-10-650 C.

2. The peer-reviewed medical literature; and

3. Commonly accepted standards of medical practice as used by practitioners across the Commonwealth

Statutory Authority

§§ 32.1-324 and 32.1-325 of the Code of Virginia.

Historical Notes

Derived from VR460-04-4.2600 § 6, eff. June 16, 1993; amended, Virginia Register Volume 21, Issue 6, eff. January 3, 2005.

12VAC30-130-330. Educational program.

A. DMAS shall develop an educational program designed to further educate physicians and pharmacists to ensure that prescriptions are appropriate, medically necessary, and are not likely to cause adverse actions. The purpose of such program shall be to:

1. Identify and reduce the frequency of patterns of fraud, abuse, overuse, or inappropriate or medically unnecessary care among physicians, pharmacists, and patients, or associated with specific drugs or groups of drugs;

2. Identify and reduce the potential and actual severe adverse reactions to drugs; and

3. Improve prescribing and dispensing practices.

Such program shall include education on therapeutic appropriateness, overutilization and underutilization, appropriate use of generic products, therapeutic duplication, drug-disease contraindications, drug-drug interactions, incorrect drug dosage or duration of drug treatment, drug-allergy interactions and clinical abuse/misuse.

B. The educational program shall be accomplished through the use of interventions. The interventions shall be directed to physicians and pharmacists and shall address therapy problems or individuals identified in the course of prospective and retrospective drug use reviews as having exceptional drug utilization patterns. The educational program shall have at least four types of interventions which shall be used as appropriate. These interventions shall include:

1. Information dissemination sufficient to ensure the ready availability to participating physicians and pharmacists of information concerning the DUR Board's duties, powers, and basis for its standards;

2. Written, oral, electronic, and telephonic reminders containing patient-specific or drug-specific (or both) information and suggested changes in prescribing or dispensing practices, which is communicated in a manner designed to ensure the privacy of patient-related information;

3. Face-to-face discussions between health care professionals who are experts in appropriate and medically necessary drug therapy and selected prescribers and pharmacists who have been targeted for intervention, including discussion of optimal prescribing, dispensing, or pharmacy care practices, and follow-up face-to-face discussions; and

4. Intensified review or monitoring of selected prescribers or dispensers.

C. DMAS may establish the educational program through contracts with accredited health care educational institutions, state medical societies or state pharmacists associations/societies or other organizations, which may include, but shall not necessarily be limited to, a pharmacy benefits manager. The educational program will use, but not be limited to, as a basis for its educational activities the compendia and literature referenced in these regulations and data obtained primarily from the prospective and retrospective DUR process, and provided by the DUR Board, on common drug therapy problems and other utilization and drug therapy issues listed in these regulations. The educational program shall be based on recommendations submitted by the DUR Board.

D. A report shall be prepared by the DUR Board and submitted to the director at least semi-annually evaluating the success of the interventions, determining if the interventions improved the quality of drug therapy, and making recommendations for modifications in the program, if appropriate.

Statutory Authority

§§ 32.1-324 and 32.1-325 of the Code of Virginia.

Historical Notes

Derived from VR460-04-4.2600 § 7, eff. June 16, 1993; amended, Virginia Register Volume 21, Issue 6, eff. January 3, 2005.

12VAC30-130-335. Other interventions.

As permitted by all applicable federal and state laws and regulations, DMAS or its designee may intervene in the process of the adjudication of claims for payment of prescription drugs. Such interventions may entail, but shall not be limited to, electronic messages, rejecting claims pending further resolution, or requiring prior authorization for selected prospective DUR criteria.

Designated interventions may include provider override, obtaining prior authorization via communication to a call center staffed with appropriate clinicians, or written communication to prescribers.

Statutory Authority

§§ 32.1-324 and 32.1-325 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 21, Issue 6, eff. January 3, 2005.

12VAC30-130-340. DUR Board.

A. The Director of DMAS shall establish the DUR Board either directly or through a contract with an outside vendor. The DUR Board shall submit recommendations on prospective and retrospective drug use review to the director. The director reserves the right to reject such recommendations and shall so notify the board consistent with federal requirements. The DUR Board shall adhere to all the requirements of client confidentiality with respect to patient specific information.

B. The DUR Board shall consist of 13 members. At least one-third of the members shall be pharmacists. At least one-third but no more than 51% of the members shall be physicians. There shall be at least one but no more than two nurse members. All pharmacist, physician and nurse members shall be licensed by the Commonwealth with such licenses in good standing. The Director of DMAS shall invite submission of candidates from each of these groups. Other individuals and groups interested in submitting names of candidates for the DUR Board shall indicate their interest to the director in writing. The director shall appoint the physician members from candidates submitted by the Medical Society of Virginia, the Old Dominion Medical Society, and each of the medical schools in the Commonwealth. The director shall appoint the pharmacist members from candidates submitted by the Medical College of Virginia/Virginia Commonwealth University School of Pharmacy, the Virginia Pharmaceutical Association, Virginia Chain Drug Store Association, and the Virginia Society of Consultant Pharmacists. The director shall appoint the nurse member or members from candidates submitted by the Virginia Nurses Association.

1. At least five of the physicians and pharmacists appointed to the DUR Board shall be licensed and actively practicing.

2. All individuals appointed to the DUR Board shall demonstrate knowledge and expertise in one or more of the following areas:

a. The clinically appropriate prescribing of covered outpatient drugs;

b. The clinically appropriate dispensing and monitoring of outpatient drugs;

c. Drug use review, evaluation, and intervention; and

d. Medical quality assurance.

C. Consistent with its by-laws, the DUR Board members shall serve at the pleasure of the director, for terms established by the director. Vacancies shall be filled in the same manner as the original appointment.

D. DMAS shall provide staff assistance to the DUR Board and its officers in the routine conduct of its business.

E. The DUR Board shall have the following duties:

1. The DUR Board shall meet no less than quarterly and, in addition, upon call by the director. A quorum for action by the DUR Board shall be seven voting members.

2. The DUR Board shall elect from among its members a chairperson and a vice-chairperson. Officers may be elected to successive terms.

3. A full record of the board's proceedings shall be kept. The record shall be open to public inspection at all reasonable times consistent with the DMAS' hours of operation.

4. The DUR Board shall establish such rules as are necessary to conduct its business.

5. The DUR Board shall review and approve the retrospective DUR criteria for consistency with the requirements set forth in these regulations.

6. The DUR Board shall establish a listing of criteria and standards for use in prospective drug use reviews. The criteria and standards may include commercial software packages, drug interaction handbooks, and other published and written criteria.

7. The DUR Board shall submit a report at least semi-annually evaluating the success of interventions and making recommendations for modifications to the educational program, if appropriate. The DUR Board shall evaluate the educational program developed by DMAS or DMAS' vendor pursuant to the requirements of these regulations and make recommendations concerning the appropriate mix of intervention approaches.

8. The DUR Board shall prepare a report on an annual basis for submission to the director which shall include a description of the activities of the DUR Board, including the nature and scope of the prospective and retrospective drug use review programs, a summary of the interventions used, an assessment of the impact of the interventions on quality of care, an estimate of the costs and savings generated as a result of such program and other information specified by the director. DMAS shall prepare and submit, on an annual basis, a report to the U.S. Secretary of Health and Human Services that incorporates the DUR Board's report and conforms to the requirements set forth in federal regulations.

Statutory Authority

§ 32.1-325 of the Code of Virginia.

Historical Notes

Derived from VR460-04-4.2600 § 8, eff. June 16, 1993.

12VAC30-130-350. DUR Committee.

A. The director shall provide for the establishment of a DUR Committee either directly or through a contract with an outside vendor. The DUR Board may serve as 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:

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.

C. The membership of the DUR Committee shall include physicians, pharmacists, and other health care professionals.

D. Activities of the DUR Committee shall include, but not be limited to, the following:

1. The review of patient, pharmacist, and physician exceptional drug utilization profiles generated from retrospective reviews applying knowledge and experience as a professional and the retrospective criteria and standards approved by the DUR Board;

2. Develop and recommend modifications to the prospective and retrospective standards based on clinical experience, new literature findings, and communications from practitioners pursuant to the educational program;

3. In instances where an exceptional drug use pattern is suggestive of fraud or abuse, make referrals in a manner consistent with the rules adopted by the DUR Board to the appropriate intra agency division;

4. Provide technical expertise to assist DMAS staff in the compilation of reports and recommendations to be presented to the DUR Board and the director.

E. The DUR Committee shall adhere to all the requirements of client confidentiality with respect to patient specific information.

Statutory Authority

§ 32.1-325 of the Code of Virginia.

Historical Notes

Derived from VR460-04-4.2600 § 9, eff. June 16, 1993.

12VAC30-130-360. Exemption of organized health care settings.

A. Covered outpatient drugs dispensed by health maintenance organizations, including those organizations that contract under § 1903(m) of the Act, are not subject to the requirements of this section.

B. A hospital (providing medical assistance under the Commonwealth's plan) that dispenses covered outpatient drugs using drug formulary systems, and bills DMAS no more than the hospital's purchasing costs for covered outpatient drugs (as determined under the State plan) shall not be subject to the requirements of this regulation.

Statutory Authority

§ 32.1-325 of the Code of Virginia.

Historical Notes

Derived from VR460-04-4.2600 § 10, eff. June 16, 1993.

12VAC30-130-370. (Repealed.)

Historical Notes

Derived from VR460-04-4.2600 § 11, eff. June 16, 1993; repealed, Virginia Register Volume 25, Issue 14, eff. April 15, 2009.

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