Texas Administrative Code
Title 1 - ADMINISTRATION
Part 15 - TEXAS HEALTH AND HUMAN SERVICES COMMISSION
Chapter 354 - MEDICAID HEALTH SERVICES
Subchapter F - PHARMACY SERVICES
Division 7 - TEXAS DRUG CODE INDEX - ADDITIONS, RETENTIONS, AND DELETIONS
Section 354.1921 - Addition of Drugs to the Texas Drug Code Index
Universal Citation: 1 TX Admin Code ยง 354.1921
Current through Reg. 49, No. 38; September 20, 2024
(a) A drug company that has a valid rebate agreement under RSA 1396r-8 may apply to the Health and Human Services Commission (Commission) to add a drug to the Texas Drug Code Index (TDCI). The term "drug company" includes any manufacturer, repackager, or private labeler.
(b) To apply for the addition of a drug to the TDCI, a drug company must complete each section of the Certification of Information for the Addition of a Drug Product to the TDCI provided by the Commission.
(c) A drug company must also:
(1) update the Commission with changes to
formulation, product status, or availability; and
(2) submit changes to the prices requested in
the Price Certification section of the Certification of Information, if
requested by the Commission, within 10 calendar days of receiving the
request.
(d) Sources other than drug companies may request the addition of a drug not currently listed in the TDCI. If the request is not from a drug company, the Commission may request that the manufacturer submit a Certification of Information as described in subsection (b) of this section.
(e) The drug company and other sources, if applicable, are entitled to receive notification of approved or denied Certifications of Information. If a Certification of Information is denied, the Commission will state the reasons for the denial.
(f) Notwithstanding any other state law, pricing information reported by a drug company under this subchapter is confidential and must not be disclosed by the Commission, its agents, contractors, or any other State agency in a format that discloses the identity of a specific manufacturer or labeler, or the prices charged by a specific manufacturer or labeler for a specific drug, except as necessary to permit the Attorney General to enforce state and federal law.
(g) Definitions. The following words and terms, when used in this chapter and in Chapter 355 of this title (relating to Reimbursement Rates), have the following meanings unless the context clearly indicates otherwise.
(1) Acquisition Cost
(AC)--HHSC's determination of the price pharmacy providers pay to acquire drug
products marketed or sold by specific manufacturers. AC is based on NADAC,
wholesale acquisition cost (WAC), or pharmacy invoice, in accordance with the
Medicaid state plan.
(2) Average
Manufacturer Price (AMP)--The average manufacturer price as defined in
RSA
1396r-8(k)(1).
(3) Average Wholesale Price (AWP)--The
average wholesale price for a drug as published in a price reporting compendium
such as First DataBank or Medispan.
(4) Customary Prompt Pay Discount--Any
discount off the purchase price of a drug routinely offered by the drug company
to a wholesaler or distributor for prompt payment of purchased drugs within a
specified time frame and consistent with customary business practices for
payment.
(5) Direct Price to Long
Term Care Pharmacy--The amount paid by a pharmacy servicing a long term care
facility, including a nursing facility, assisted living facility, and skilled
nursing facility. The price should be net of price concessions. In reporting
this price point to the Commission, if the price is reported as a range, the
weighted average of these prices, based on unit sales, must be included. The
following prices should be excluded from this price point:
(A) prices excluded from the determination of
Medicaid Best Price at 42 C.F.R. § 447.505; and
(B) prices to entities participating in the
Health Resources and Services Administration (HRSA) 340b discount
program.
(6) Direct
Price to Pharmacy--The amount paid for a product by a pharmacy when purchased
directly from a drug company. This price should be net of Price Concessions. In
reporting this price point to the Commission, if the price is reported as a
range, the weighted average of these prices, based on unit sales, must be
included. The following prices should be excluded from this price point:
(A) prices excluded from the determination of
Medicaid Best Price at 42 C.F.R. § 447.505;
(B) prices to entities participating in the
Health Resources and Services Administration (HRSA) 340b discount program;
and
(C) Direct Prices to Long Term
Care Pharmacy.
(7) Gross
Amount Due--Has the meaning as defined by the National Council for Prescription
Drug Programs.
(8) Long term care
facility--Facility that provides long term care services, such as a nursing
home, skilled nursing facility, assisted living facility, group home, hospice
facility, or intermediate care facility for individuals with an intellectual
disability or related condition (ICF/IID).
(9) Long term care pharmacy--A pharmacy for
which the total Medicaid claims for prescription drugs to residents of long
term care facilities exceeds 50 percent of the pharmacy's total Medicaid claims
per year. Long term care pharmacies are not open to the public for walk-in
business.
(10) Long term care
pharmacy acquisition cost (LTCPAC)--The acquisition cost determined by the
Commission for a drug product purchased by a long term care pharmacy.
(11) "May apply to the Commission"--The act
of applying to have a drug included on the TDCI. This includes completing the
Certification of Information for the Addition of a New Drug Product to the
Texas Drug Code Index, submitting National Drug Code (NDC) changes, submitting
price updates, and submitting additional package sizes for a drug that is
already included on the TDCI.
(12)
NADAC--National Average Drug Acquisition Cost.
(13) National Drug Code (NDC)--The 11-digit
numerical code established by the U.S. Food and Drug Administration that
indicates the labeler, product, and package size.
(14) Pharmacy--An entity with an approved
community pharmacy license or an institutional pharmacy license.
(15) Price concession--An action by a
manufacturer (other than a customary prompt-pay discount as defined in this
section) that has the effect of reducing the net cost of a product to a
purchaser. The term includes discounts, rebates, billbacks, chargebacks, or
other adjustments to pricing or payment terms. Lagged price concessions must be
accounted for in the Reported Manufacturer Pricing by operation of a 12-month
average estimation methodology as described in 42 C.F.R. § 414.804. For
new, at launch products, if a manufacturer has forecasted price concessions,
the initial Reported Manufacturer Pricing should reflect this internal business
information.
(16) Price to
Wholesaler/Distributor--The amount paid by a wholesaler or a distributor. The
price should be net of price concessions. In reporting this price point to the
Commission, if the price is reported as a range, the weighted average of these
prices, based on unit sales, must be included. The following prices should be
excluded from this price point:
(A) prices
excluded from the determination of Medicaid Best Price at 42 C.F.R. §
447.505; and
(B) prices to entities
participating in the Health Resources and Services Administration (HRSA) 340b
discount program.
(17)
Reliable Sources--Sources including other state or federal agencies and pricing
services, as well as verifiable reports by contracted providers and Vendor Drug
Program formulary and field staff.
(18) Reported Manufacturer Pricing--Pricing
information submitted to the Commission by a drug company on a Certification of
Information, or in subsequent price updates as described in subsections (b) and
(c) of this section. This includes: Average Wholesale Price, Average
Manufacturer Price, Price to Wholesaler/Distributor, Direct Price to Pharmacy,
and Direct Price to Long Term Care Pharmacy. If a drug company does not have a
single price for a price point, it must report a range of prices. If a drug
company reports a range of prices, it must also provide the weighted average of
these prices based on unit sales.
(19) Retail Pharmacy Acquisition Cost
(RetailPAC)--HHSC's determination of the price a retail pharmacy pays to
acquire drug products marketed or sold by specific manufacturers.
(20) Specialty pharmacy--A pharmacy that
meets all of the following criteria:
(A)
total Medicaid claims for specialty drugs, as described in §
RSA 354.1853 of
this subchapter (relating to Specialty Drugs), exceeds 10 percent of the
pharmacy's total Medicaid claims per year;
(B) obtains volume-based discounts or rebates
on specialty drugs from manufacturers or wholesalers; and
(C) delivers at least 80 percent of dispensed
prescriptions by shipment through the U.S. Postal Service or other common
carrier to customers or healthcare professionals (including physicians and home
health providers).
(21)
Specialty pharmacy acquisition cost (SPAC)--HHSC's determination of the price a
retail pharmacy pays to acquire drug products marketed or sold by specific
manufacturers.
(22) Weighted AMP
(Average Manufacturer Price)--The Weighted AMP (Average Manufacturer Price) as
contemplated in
RSA
1396r-8(b)(3) and (e), and
as reported by the Centers for Medicare & Medicaid Services.
(23) Wholesaler Cost--The net cost of a
product to a wholesaler; equivalent to Price to Wholesaler/Distributor and cost
to wholesaler.
Disclaimer: These regulations may not be the most recent version. Texas may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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