1 Tex. Admin. Code § 354.1921 - Addition of Drugs to the Texas Drug Code Index
(a) A drug company that has a valid rebate
agreement under 42 U.S.C.
§
1396r-8 may apply to HHSC 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 Certificate of
Information for the Addition of a Drug Product to the TDCI provided by
HHSC.
(c) A drug company must also:
(1) update HHSC with changes to formulation,
product status, or availability; and
(2) submit changes to the prices requested in
the Price Certification section of the Certificate of Information, if requested
by HHSC, within 10 calendar days of receiving the request.
(d) When a drug company manufactures a
brand-name insulin prescription drug for which a generic or biosimilar
prescription drug is not available, but the generic or biosimilar prescription
drug is in the VDP formulary, the manufacturer must submit to HHSC a written
verification stating whether or not the unavailability of the generic or
biosimilar prescription drug is the result, wholly or partly, of:
(1) a scheme by the manufacturer to pay a
generic or biosimilar prescription drug manufacturer to delay manufacturing or
marketing the generic or biosimilar drug;
(2) a legal or business strategy to extend
the life of a patent on the brand name prescription drug;
(3) the manufacturer directly manipulating a
patent on the brand name prescription drug; or
(4) the manufacturer facilitating an action
described by paragraphs (1) - (3) of this subsection on behalf of another
entity.
(e) The written
verification as described in subsection (d) of this section must be provided by
the manufacturer to HHSC:
(1) by submitting a
Certificate of Information; and
(2)
on a yearly basis thereafter through the supplemental rebate solicitation
process.
(f) 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, HHSC may request
that the manufacturer submit a Certificate of Information as described in
subsection (b) of this section.
(g)
HHSC adds drugs to the TDCI on a provisional basis after HHSC receives a
Certificate of Information that is then approved by HHSC, or is pending review
by HHSC for a determination by HHSC that the drug is appropriate for dispensing
through an outpatient pharmacy and meets the additional requirements in Texas
Government Code §
531.0691.
(h) The drug company and other sources, if
applicable, are entitled to receive notification of approved or denied
Certifications of Information. If a Certificate of Information is denied, HHSC
will state the reasons for the denial.
(i) Notwithstanding any other state law,
pricing information reported by a drug company under this subchapter is
confidential and must not be disclosed by HHSC, 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.
(j) 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
42 USC §
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 HHSC, 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 HHSC, 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 HHSC for
a drug product purchased by a long term care pharmacy.
(11) "May apply to HHSC "--The act of
applying to have a drug included on the TDCI. This includes completing the
Certificate 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
HHSC, 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 HHSC by a drug company on a Certificate of
Information, or in subsequent price updates as described in subsections (b) and
(c) of this section. This pricing information includes: AWP, AMP, 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 §
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
42 U.S.C. §
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.
Notes
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