Kentucky Administrative Regulations › Title 907 - CABINET FOR HEALTH AND FAMILY SERVICES - DEPARTMENT FOR MEDICAID SERVICES › Chapter 23 - Outpatient Pharmacy Program › Section 907 KAR 23:001 - Definitions for 907 KAR Chapter 23

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				205.560,
				205.561,
				205.5631,
				205.5632,
				205.5634,
				205.5636,
				205.5638,
				205.5639,
				205.6316(4),
				217.015,
				42
				C.F.R. 440.120,
				447.500 -
				447.520,
				42
				U.S.C. 256b,
				1396a
				- 1396d,
				1396r-8
NECESSITY, FUNCTION, AND CONFORMITY: The Cabinet for Health and
				Family Services, Department for Medicaid Services, has responsibility to
				administer the Medicaid Program.
				KRS
				205.520(3) authorizes the
				cabinet, by administrative regulation, to comply with a requirement that may be
				imposed or opportunity presented by federal law to qualify for federal Medicaid
				funds. This administrative regulation establishes the definitions for 907 KAR
				Chapter 23.
Section 1. Definitions.
(1) "340B ceiling price" means the maximum
			 statutory price established under Section 340B of the Public Health Service Act
			 (340B Program),
			 42
			 U.S.C. 256b, and as calculated according to
			 42 C.F.R.
			 10.10.
(2) "Actual 340B acquisition cost" means the
			 actual price paid for a drug purchased through the 340B program.
(3) "Average sales price" or "ASP" means the
			 average sales price reported quarterly by the drug manufacturer to the Centers
			 for Medicare and Medicaid Services (CMS).
(4) "Brand name drug" means the registered
			 trade name of a drug that was originally marketed under an original new drug
			 application approved by the Food and Drug Administration.
(5) "Commissioner" is defined by
			 KRS
			 205.5631(1).
(6) "Covered drug" means a drug for which the
			 Department for Medicaid Services provides reimbursement if medically necessary,
			 not otherwise excluded, and provided in accordance with
			 907 KAR
			 23:010.
(7) "Covered outpatient drug" is defined by
			 42 U.S.C.
			 1396r-8(k)(2), unless excluded by
			 907 KAR
			 23:010 or
			 907
			 KAR 23:020.
(8) "Department" means the Department for
			 Medicaid Services or its designated agent.
(9) "Department's pharmacy webpage" means the
			 site maintained by the Department for Medicaid Services and accessible at
http://www.chfs.ky.gov/dms/Pharmacy
.
(10) "Department's pharmacy web portal" means
			 the portal that:
(a) Provides online access to
			 prescription and Kentucky specific plan information as well as supporting
			 documentation; and
(b) Is
			 accessible through the department's pharmacy webpage.
(11) "Dosage form" means the type of physical
			 formulation used to deliver a drug to the intended site of action and includes
			 a tablet, an extended release tablet, a capsule, an elixir, a solution, a
			 powder, a spray, a cream, an ointment, or any other distinct physical
			 formulation recognized as a dosage form by the Food and Drug
			 Administration.
(12) "Drug
			 Management Review Advisory Board" or "DMRAB" means the advisory board
			 established pursuant to
			 KRS
			 205.5636.
(13) "Effective" or "effectiveness" means a
			 finding that a pharmaceutical agent does or does not have a significant,
			 clinically-meaningful therapeutic advantage in terms of safety, usefulness, or
			 clinical outcome over the other pharmaceutical agents based on pertinent
			 information from a variety of sources determined by the department to be
			 relevant and reliable.
(14)
			 "Emergency supply" means a seventy-two (72) hour supply.
(15) "Enrollee" means a recipient who is
			 enrolled with a managed care organization.
(16) "Federal financial participation" is
			 defined by
			 42 C.F.R.
			 400.203.
(17) "Federal upper limit" or "FUL" means the
			 upper payment limit for multiple source drugs for which a limit has been
			 established by CMS as defined by
			 42 C.F.R.
			 447.512,
			 447.514,
			 and
			 447.516.
(18) "Food and Drug Administration" or "FDA"
			 means the Food and Drug Administration of the United States Department of
			 Health and Human Services.
(19)
			 "Generic drug" or "generic form" means a drug that contains identical amounts
			 of the same active drug ingredients in the same dosage form and that meets
			 official compendia or other applicable standards of strength, quality, purity,
			 and identity in comparison with the brand name drug.
(20) "Kentucky Medicaid Fee-for-Service
			 Outpatient Drug List" or "Outpatient Drug List" means each list available
			 through the department's pharmacy webpage that:
(a) Specifies drugs, drug categories, and
			 related covered items;
(b)
			 Indicates prior authorization requirements or special prescribing or dispensing
			 restrictions;
(c) Identifies
			 excluded medical uses; and
(d)
			 Includes other drug related information, such as:
1. Formulary status, drug coverage, and other
			 plan limitations (prior authorization, quantity limits, step therapy, and
			 diagnosis) associated with a drug;
2. The selected drugs available to
			 fee-for-service recipients that have been included based on proven clinical and
			 cost effectiveness and that prescribers are encouraged to prescribe if
			 medically appropriate;
3. Physician
			 administered drugs that may be billed to the fee-for-service medical benefit
			 using appropriate Healthcare Common Procedure Coding System codes, National
			 Drug Codes, and appropriate units;
4. Over-the-counter drugs that, if
			 prescribed, are eligible for fee-for-service coverage and reimbursement through
			 the pharmacy benefit;
5. Legend
			 cold and cough drugs and legend vitamin products that, if prescribed and FDA
			 indicated for the intended use, are eligible for fee-for-service coverage and
			 reimbursement through the pharmacy benefit;
6. Over-the-counter drugs that, if provided
			 to a Medicaid nursing facility service recipient, are included in the nursing
			 facility's standard price or daily per diem rate and are not otherwise
			 reimbursed by the department;
7.
			 Covered drugs that have a quantity limit consistent with the maximum dosage
			 that the FDA has approved to be both safe and effective; and
8. Covered drugs that require a diagnosis
			 code or a prerequisite to therapy, or both.
(21) "Legend drug" means a drug so defined by
			 the FDA and required to bear the statement: "Caution: Federal law prohibits
			 dispensing without prescription".
(22) "Managed care organization" means an
			 entity for which the department has contracted to serve as a managed care
			 organization as defined by
			 42
			 C.F.R. 438.2.
(23) "Manufacturer" is defined by
			 42 U.S.C.
			 1396r-8(k)(5).
(24) "Maximum allowable cost" or "MAC" means
			 a Kentucky-specific maximum amount that:
(a)
			 May be established for any drug for which there are two (2) or more A-rated
			 therapeuti-cally equivalent, multiple-source, non-innovator drugs, as
			 established in
			 907
			 KAR 23:020, Section 5; and
(b) Is an acquisition cost based model that
			 includes all types of medications, including specialty and hemophilia
			 products.
(25)
			 "Medically necessary" or "medical necessity" means that a covered benefit is
			 determined to be needed in accordance with
			 907
			 KAR 3:130.
(26) "National Average Drug Acquisition Cost"
			 or "NADAC" means the average acquisition cost for drug ingredients for
			 prescribed and covered outpatient drugs determined by a survey of retail
			 community pharmacy providers as published by CMS.
(27) "Official compendia" or "compendia" is
			 defined by
			 42 U.S.C.
			 1396r-8(g)(1)(B)(i).
(28) "Over-the-counter" or "OTC" means a drug
			 approved by the FDA to be sold without bearing the statement "Caution: Federal
			 law prohibits dispensing without prescription".
(29) "Pharmacy and Therapeutics Advisory
			 Committee" or "P&T Committee" means the pharmacy advisory committee
			 established by
			 KRS
			 205.564 and in compliance with
			 45 C.F.R.
			 156.122.
(30) "Pharmacy provider" means a pharmacy
			 that is:
(a) Within the scope of practice
			 under Kentucky licensing laws and has the legal authority to operate as a
			 pharmacy;
(b) Enrolled in the
			 Medicaid Program pursuant to
			 907
			 KAR 1:672; and
(c) Currently participating in the Medicaid
			 Program pursuant to
			 907
			 KAR 1:671.
(31) "Physician administered drug" or "PAD"
			 means any rebateable covered outpatient drug that is:
(a) Provided or administered to a Medicaid
			 recipient;
(b) Billed by a provider
			 other than a pharmacy provider through the medical benefit, including providers
			 who are physician offices or another outpatient clinical setting; and
(c) An injectable or non-injectable drug
			 furnished incident to provider services that are billed separately to
			 Medicaid.
(32)
			 "Prescribed drug" is defined by
			 42 U.S.C.
			 1396r-8(k)(4).
(33) "Prescriber" means a health care
			 professional who:
(a) Within the scope of
			 practice under Kentucky licensing laws, has the legal authority to write or
			 order a prescription for the drug that is ordered;
(b) Is enrolled in the Medicaid Program
			 pursuant to
			 907
			 KAR 1:672; and
(c) Is currently participating in the
			 Medicaid Program pursuant to
			 907
			 KAR 1:671.
(34) "Prior authorization request form" means
			 a form that is:
(a) Used to request prior
			 authorization for a prescription as established by
			 907 KAR
			 23:010; and
(b) Called either the:
1. Kentucky Medicaid Substance Use Treatment
			 Pharmacy Prior Authorization Form for Bu-prenorphine Products; or
2. Kentucky Medicaid Pharmacy Prior
			 Authorization Form.
(35) "Professional dispensing fee" means the
			 fee paid to reimburse a pharmacy provider for professional costs associated
			 with dispensing as defined by
			 42 C.F.R.
			 447.502.
(36) "Rebateable drug" means a drug for which
			 the drug manufacturer has entered into and has in effect a rebate agreement in
			 accordance with
			 42 U.S.C.
			 1396r-8(a).
(37) "Recipient" is defined by
			 KRS
			 205.8451(9).
(38) "Supplemental rebate" means a cash
			 rebate that offsets a Kentucky Medicaid expenditure and that supplements the
			 Centers for Medicare and Medicaid Services National Rebate Program.
(39) "Therapeutically equivalent" means
			 determined to be therapeutically equivalent by the FDA.
(40) "Usual and customary price" means the
			 provider's usual and customary charge to the public, as identified by the claim
			 charge.
(41) "Wholesale acquisition
			 cost" or "WAC" means the list price paid by a wholesaler, distributor, or other
			 direct accounts for drugs purchased from the wholesaler's supplier as listed in
			 a nationally recognized comprehensive drug data file for which the department
			 has contracted.