Current through Register Vol. 50, No. 6, December 1, 2023
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.
43 Ky.R. 2088;
eff. 10-6-2017.
STATUTORY AUTHORITY:
KRS
194A.030(2),
194A.050(1),
205.520(3),
205.560,
205.561(2),
205.6316(4),
42 U.S.C.
1396a(a)(30),
42 U.S.C.
1396r-8