Current through September 24, 2024
A. The Division of
Medicaid defines a 340B provider as a nonprofit healthcare organization that
meets the requirements of, and is considered to be, a covered entity under
Section 340B of the Public Health Service Act which has elected to enroll in
the 340B program.
B. The Division
of Medicaid defines 340B purchased drugs as those:
1. Produced by any manufacturer which has
entered into and complies with an agreement under Section 1927 (a) of the Act
which are prescribed for a medically acceptable indication,
2. Purchased and administered or dispensed by
340B covered entities under the rules of the 340B program, and
3. Dispensed and administered to a 340B
eligible beneficiary as defined in Miss. Admin. Code Part 200, Rule
4.10.C.
C. The Division
of Medicaid defines an individual as a 340B eligible beneficiary if:
1. The individual has established a
relationship with the covered entity, such that the covered entity maintains
records of the individual's healthcare,
2. The individual received healthcare
services from a healthcare professional who is either employed by the covered
entity or provides healthcare under contractual or other arrangements such that
responsibility for the care provided remains with the covered entity,
and
3. The individual receives a
healthcare service or range of services from the covered entity which is
consistent with the service or range of services for which grant funding or
federally qualified health center look-alike status has been provided to the
entity. Disproportionate share hospitals are exempt from this
requirement.
D. Covered
entities:
1. Eligibility to participate in the
340B program includes, but is not limited to:
a) Health Centers including, but not limited
to:
1) Federally Qualified Health
Centers,
2) Federally Qualified
Health Center Look-Alikes, and
3)
Tribal/Urban Indian Health Centers.
b) Hospitals including, but not limited to:
1) Children's Hospitals,
2) Critical Access Hospitals,
3) Disproportionate Share
Hospitals,
4) Free Standing Cancer
Hospitals,
5) Rural Referral
Centers, and
6) Sole Community
Hospitals.
c)
Specialized Clinics including, but not limited to:
1) Black Lung Clinics,
2) Comprehensive Hemophilia Diagnostic
Treatment Centers,
3) Title X
Family Planning Clinics,
4)
Sexually Transmitted Disease Clinics, and
5) Tuberculosis Clinics.
2. Must comply with all Health
Resources and Service Administration's (HRSA's) regulations and
requirements.
3. Must maintain
detailed and auditable records regarding the compliance with all the Division
of Medicaid's 340B program requirements and policies.
E. Covered entities:
1. Must notify the Division of Medicaid of
their election to participate in or to terminate from the federal 340B
program.
2. Who participate in the
federal 340B drug program must notify the Division of Medicaid of their
election to opt-in or opt-out of billing the Division of Medicaid for 340B
purchased drugs and must comply with the following.
a) The Division of Medicaid defines opt-in as
a provider electing to dispense and/or administer drugs which have been
purchased under the rules of the 340B federal program, and billing the Division
of Medicaid for eligible Medicaid beneficiaries enrolled in either
fee-for-service (FFS) or in a coordinated care organization (CCO). These
covered entities must:
1) Register, enroll and
receive an identification number from HRSA.
2) Complete, sign and submit the Division of
Medicaid's 340B Covered Entity Attestation & Provider Enrollment Form to
the Division of Medicaid indicating enrollment in the 340B program.
3) Recertify with HRSA annually and notify
the Division of Medicaid in writing by submitting the 340B Covered Entity
Attestation & Provider Enrollment Form of any changes in 340B election
status.
4) Dispense/administer
covered 340B drugs purchased under the 340B program only to eligible
beneficiaries.
5) Bill the Division
of Medicaid according to Miss. Admin. Code Part 200, Rule 4.10.F.
6) Submit drug invoices as required by the
Division of Medicaid for auditing purposes.
b) The Division of Medicaid defines opt-out
as a covered entity electing never to bill the Division of Medicaid for 340B
purchased drugs. These covered entities must complete, sign and submit to the
Division of Medicaid the 340B Covered Entity Attestation & Provider
Enrollment Form indicating election to opt-out.
c) Covered entities must notify the Division
of Medicaid immediately of any change in election in billing the Division of
Medicaid for 340B purchased drugs.
F. 340B covered entities who have elected to
opt-in must bill the Division of Medicaid for dispensed/administered 340B
purchased drugs as follows:
1. For
point-of-sale (POS) claims, pharmacy providers must bill the ingredient cost at
the actual acquisition cost (AAC) in effect as of July 1, 2021, defined as the
price the pharmacy paid the wholesaler or manufacturer for the 340B purchased
drug with no mark-up plus the applicable professional dispensing fee. Providers
must identify 340B purchased drugs dispensed or administered with the
appropriate National Council for Prescription Drug Programs' (NCPDP) field
values as defined by the Division of Medicaid.
2. For medical claims, providers must bill
340B purchased Physician Administered Drugs (PAD) at the same cost in effect
for State Fiscal Year (SFY) 2021, with the appropriate modifier to identify the
340B purchased drug and the corresponding Healthcare Common Procedure Coding
System (HCPCS) and National Drug Code (NDC).
G. Under Miss. Admin. Code Part 200, Rule
1.3, a provider who knowingly or
willfully makes, or causes to be made, false statement or representation of a
material fact in any application for Medicaid benefits or Medicaid payments may
be prosecuted under Federal and State criminal laws.
H. A contract pharmacy, defined by the
Division of Medicaid as an agent of a 340B covered entity and ineligible to be
a freestanding 340B covered entity, cannot dispense and bill the Division of
Medicaid for 340B outpatient drugs for Medicaid beneficiaries.
I. A covered entity found in violation of
Miss. Admin. Code Part 200, Rule 4.10.D.2. and D.3. is liable to the
manufacturer of the covered outpatient drug that is the subject of the
violation in an amount equal to the reduction in the price of the drug provided
under the agreement between the entity and the manufacturer.
42
U.S.C. 256 b; 42 C.F.R Part 10;
42 C.F.R.
447.512; Miss. Code Ann 43-13117, 43-13-121;
SPA 17-0002.
