Virginia Administrative Code › Title 12 - HEALTH › Agency 30 - DEPARTMENT OF MEDICAL ASSISTANCE SERVICES › Chapter 50 - AMOUNT, DURATION, AND SCOPE OF MEDICAL AND REMEDIAL CARE SERVICES › Part III - Amount, Duration, and Scope of Services › Section 12VAC30-50-210 - Prescribed drugs, dentures, and prosthetic devices, and eyeglasses prescribed by a physician skilled in diseases of the eye or by an optometrist

Current through Register Vol. 40, No. 24, July 15, 2024
A. Prescribed
				  drugs.
1. Drugs for which Federal Financial
				  Participation is not available, pursuant to the requirements of § 1927 of
				  the Social Security Act (OBRA 90 § 4401), shall not be covered.
2. Nonlegend drugs shall be covered by
				  Medicaid in the following situations:
a.
				  Insulin, syringes, and needles for diabetic patients;
b. Diabetic test strips for Medicaid
				  recipients younger than 21 years of age;
c. Family planning supplies;
d. Designated categories of nonlegend drugs
				  for Medicaid recipients in nursing homes;
e. Designated drugs prescribed by a licensed
				  prescriber to be used as less expensive therapeutic alternatives to covered
				  legend drugs; and
f. U.S.
				  Environmental Protection Agency-registered insect repellents with one of the
				  following active ingredients: DEET, picaridin, IR3535, oil of lemon eucalyptus,
				  or p-Menthane-3,8-diol for all Medicaid members of reproductive age (ages 14
				  through 44 years) and all pregnant women, when prescribed by an authorized
				  health professional.
3.
				  Legend drugs are covered for a maximum of a 34-day supply per prescription per
				  patient with the exception of the drugs or classes of drugs identified in
				  12VAC30-50-520. FDA-approved drug therapies and agents for weight loss, when
				  preauthorized, will be covered for recipients who meet the strict disability
				  standards for obesity established by the Social Security Administration in
				  effect on April 7, 1999, and whose condition is certified as life threatening,
				  consistent with Department of Medical Assistance Services' medical necessity
				  requirements, by the treating physician. For prescription orders for which
				  quantity exceeds a 34-day supply, refills may be dispensed in sufficient
				  quantity to fulfill the prescription order within the limits of federal and
				  state laws and regulations.
4.
				  Prescriptions for Medicaid recipients for multiple source drugs subject to 42
				  CFR 447.332 shall be filled with generic drug products unless the physician or
				  other practitioners so licensed and certified to prescribe drugs certifies in
				  his own handwriting "brand necessary" for the prescription to be dispensed as
				  written or unless the drug class is subject to the preferred drug list.
5. New drugs shall be covered in
				  accordance with the Social Security Act § 1927(d) (OBRA 90 § 4401).
6. The number of refills shall be
				  limited pursuant to § 54.1-3411 of the Drug Control Act.
7. Drug prior authorization.
a. Definitions. The following words and terms
				  used in this section shall have the following meanings unless the context
				  clearly indicates otherwise:
"Clinical data" means drug monographs as well as any
					 pertinent clinical studies, including peer review literature.
"Complex drug regimen" means treatment or course of therapy
					 that typically includes multiple medications, co-morbidities, or caregivers.
"Department" or "DMAS" means the Department of Medical
					 Assistance Services.
"Drug" shall have the same meaning, unless the context
					 otherwise dictates or the board otherwise provides by regulation, as provided
					 in the Drug Control Act (§ 54.1-3400 et seq. of the Code of Virginia).
"Emergency supply" means 72-hour supplies of the prescribed
					 medication that may be dispensed if the prescriber cannot readily obtain
					 authorization, or if the physician is not available to consult with the
					 pharmacist, including after hours, weekends, and holidays and the pharmacist,
					 in his professional judgment consistent with current standards of practice,
					 feels that the patient's health would be compromised without the benefit of the
					 drug, or other criteria defined by the Pharmacy and Therapeutics Committee and
					 DMAS.
"Nonpreferred drugs" means those drugs that were reviewed
					 by the Pharmacy and Therapeutics Committee and not included on the preferred
					 drug list. Nonpreferred drugs may be prescribed but require authorization prior
					 to dispensing to the patient.
"Pharmacy and Therapeutics Committee," "P&T Committee"
					 or "committee" means the committee formulated to review therapeutic classes,
					 conduct clinical reviews of specific drugs, recommend additions or deletions to
					 the preferred drug list, and perform other functions as required by the
					 department.
"Preferred drug list" or "PDL" means the list of drugs that
					 meet the safety, clinical efficacy, and pricing standards employed by the
					 P&T Committee and adopted by the department for the Virginia Medicaid
					 fee-for-service program. Most drugs on the PDL may be prescribed and dispensed
					 in the Virginia Medicaid fee-for-service program without prior authorization;
					 however, some drugs as recommended by the Pharmacy and Therapeutics Committee
					 may require authorization prior to dispensing to the patient.
"Prior authorization," as it relates to the PDL, means the
					 process of review by a clinical pharmacist of legend drugs that are not on the
					 preferred drug list, or other drugs as recommended by the Pharmacy and
					 Therapeutics Committee, to determine if medically justified.
"State supplemental rebate" means any cash rebate that
					 offsets Virginia Medicaid expenditure and that supplements the federal rebate.
					 State supplemental rebate amounts shall be calculated in accordance with the
					 Virginia Supplemental Drug Rebate Agreement Contract and Addenda.
"Therapeutic class" means a grouping of medications sharing
					 the same Specific Therapeutic Class Code (GC3) within the Federal Drug Data
					 File published by First Data Bank, Inc.
"Utilization review" means the prospective and
					 retrospective processes employed by the agency to evaluate the medical
					 necessity of reimbursing for certain covered services.
b. Medicaid Pharmacy and Therapeutics
				  Committee.
(1) The department shall utilize a
				  Pharmacy and Therapeutics Committee to assist in the development and ongoing
				  administration of the preferred drug list and other pharmacy program issues.
				  The committee may adopt bylaws that set out its make-up and functioning. A
				  quorum for action of the committee shall consist of seven members.
(2) Vacancies on the committee shall be
				  filled in the same manner as original appointments. DMAS shall appoint
				  individuals for the committee that assures a cross-section of the physician and
				  pharmacy community and remains compliant with General Assembly membership
				  guidelines.
(3) Duties of the
				  committee. The committee shall receive and review clinical and pricing data
				  related to the drug classes. The committee's medical and pharmacy experts shall
				  make recommendations to DMAS regarding various aspects of the pharmacy program.
				  For the preferred drug list program, the committee shall select those drugs to
				  be deemed preferred that are safe, clinically effective, as supported by
				  available clinical data, and meet pricing standards. Cost effectiveness or any
				  pricing standard shall be considered only after a drug is determined to be safe
				  and clinically effective.
(4) As
				  the U.S. Food and Drug Administration (FDA) approves new drug products, the
				  department shall ensure that the Pharmacy and Therapeutics Committee will
				  evaluate the drug for clinical effectiveness and safety. Based on clinical
				  information and pricing standards, the P&T Committee will determine if the
				  drug will be included in the PDL or require prior authorization.
(a) If the new drug product falls within a
				  drug class previously reviewed by the P&T Committee, until the review of
				  the new drug is completed, it will be classified as nonpreferred, requiring
				  prior authorization in order to be dispensed. The new drug will be evaluated
				  for inclusion in the PDL no later than at the next review of the drug class.
(b) If the new drug product does
				  not fall within a drug class previously reviewed by the P&T Committee, the
				  new drug shall be treated in the same manner as the other drugs in its class.
(5) To the extent
				  feasible, the Pharmacy and Therapeutics Committee shall review all drug classes
				  included in the preferred drug list at least every 12 months and may recommend
				  additions to and deletions from the PDL.
(6) In formulating its recommendations to the
				  department, the committee shall not be deemed to be formulating regulations for
				  the purposes of the Administrative Process Act (§ 2.2-4000 et seq. of the
				  Code of Virginia).
(7) Immunity.
				  The members of the committee, the staff of the department, and the contractor
				  shall be immune, individually and jointly, from civil liability for any act,
				  decision, or omission done or made in performance of their duties pursuant to
				  this subsection while serving as a member of such board, committee, or staff
				  provided that such act, decision, or omission is not done or made in bad faith
				  or with malicious intent.
c. Pharmacy prior authorization program.
				  Pursuant to § 1927 of the Act and 42 CFR 440.230, the department shall
				  require the prior authorization of certain specified legend drugs. For those
				  therapeutic classes of drugs subject to the PDL program, drugs with
				  nonpreferred status included in the DMAS drug list shall be subject to prior
				  authorization. The department also may require prior authorization of other
				  drugs only if recommended by the P&T Committee. Providers who are licensed
				  to prescribe legend drugs shall be required to obtain prior authorization for
				  all nonpreferred drugs or other drugs as recommended by the P&T Committee.
(1) Prior authorization shall consist of
				  prescription review by a licensed pharmacist or pharmacy technician to ensure
				  that all predetermined clinically appropriate criteria, as established by the
				  P&T Committee relative to each therapeutic class, have been met before the
				  prescription may be dispensed. Prior authorization shall be obtained through a
				  call center staffed with appropriate clinicians, or through written or
				  electronic communications (e.g., faxes, mail). Responses by telephone or other
				  telecommunications device within 24 hours of a request for prior authorization
				  shall be provided. The dispensing of 72-hour emergency supplies of the
				  prescribed drug may be permitted and dispensing fees shall be paid to the
				  pharmacy for such emergency supply.
(2) The preferred drug list program shall
				  include (i) provisions for an expedited review process of denials of requested
				  prior authorization by the department; (ii) consumer and provider education;
				  and (iii) training and information regarding the preferred drug list both prior
				  to implementation as well as ongoing communications, to include computer and
				  website access to information and multilingual material.
(3) Exclusion of protected groups from the
				  pharmacy preferred drug list prior authorization requirements. The following
				  groups of Medicaid eligibles shall be excluded from pharmacy prior
				  authorization requirements: individuals enrolled in hospice care, services
				  through PACE or pre-PACE programs; persons having comprehensive third party
				  insurance coverage; minor children who are the responsibility of the juvenile
				  justice system; and refugees who are not otherwise eligible in a Medicaid
				  covered group.
d.
				  Supplemental rebates. The department has the authority to seek supplemental
				  rebates from pharmaceutical manufacturers. In addition to collecting
				  supplemental rebates for fee-for-service claims, the department may, at its
				  option, also collect supplemental rebates for Medicaid member utilization
				  through MCOs under an agreement. Supplemental rebate agreements shall be
				  separate from the federal rebates and in compliance with federal law,
				  §§ 1927(a)(1) and 1927(a)(4) of the Social Security Act. All rebates
				  collected on behalf of the Commonwealth shall be collected for the sole benefit
				  of the state share of costs.
e.
				  Pursuant to 42 USC § 1396r-8(b)(3)(D), information disclosed to the
				  department or to the committee by a pharmaceutical manufacturer or wholesaler
				  which discloses the identity of a specific manufacturer or wholesaler and the
				  pricing information regarding the drugs by such manufacturer or wholesaler is
				  confidential and shall not be subject to the disclosure requirements of the
				  Virginia Freedom of Information Act (§ 2.2-3700 et seq. of the Code of
				  Virginia).
f. Appeals for denials
				  of prior authorization shall be addressed pursuant to 12VAC30-110, Part I,
				  Client Appeals.
8.
				  Coverage of home infusion therapy. This service shall be covered consistent
				  with the limits and requirements set out within home health services
				  (12VAC30-50-160 ). Multiple applications of the same therapy (e.g., two
				  antibiotics on the same day) shall be covered under one service day rate of
				  reimbursement. Multiple applications of different therapies (e.g.,
				  chemotherapy, hydration, and pain management on the same day) shall be a full
				  service day rate methodology as provided in pharmacy services reimbursement.