Texas Register, Volume 12, Number 57, Pages 2453-2487, July 28, 1987 Page: 2,474
2453-2487 p. ; 28 cm.View a full description of this periodical.
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(b) The tape input service bureau must
submit a listing of the company's input for
each week. The format generally follows the
payment register format. Additionally, there
must be a summary, by vendor, of the total
number of claims (per page, per tape and
total input) and dollar amount. The weekly
listings are in vendor number order.
(c) In computer programs, service bu-
reau companies provide the correct numeric
Texas Drug Code for all drugs and package
sizes covered by the Texas Drug Code In-
dex and updates. Use of a single code to
cover a similar drug of several manufacturers
is not permitted because the variation in
estimated acquisition cost.
(d) Sequential numbers must be used
by a service bureau company on claims, be-
ginning with number one to infinity, so that
claims can be referenced and located, re-
searched, and audited by the department.
The sequential number assigned claims by
the service bureau company serve as the
preprint number on the pharmacy claim
form.
(e) Each service bureau company must
handle its vendors' corrections. The service
bureau must have a program in its processs-
ing system that allows it to recycle corrected
claims. Dual input by a pharmacy provider,
partially by tape and partially by use of the
pharmacy claim form, must be avoided.
(f) Each week each service bureau
company must submit an updated list of the
vendors participating in its processing
system. The Pharmacy Provider Enrollment
section must be notified of participation of
new vendors and cancellation of previous
vendors. Specific beginning and ending dates
for participating vendors must be included
in the notification. The Pharmacy Provider
Enrollment section must also be supplied
with a copy of the contract between the ser-
vice bureau company and its vendors.
(g) The Pharmacy Provider Enroll-
ment section sends tape record layout for-
mat to potential contractors to ensure that
the tape record layout conforms with the re-
quirements of the Office of Information
.Systems.
This agency hereby certifies that the pro.
posal has been reviewed by legal counsel
and found to be within the agency's
authority to adopt.
Issued in Austin, Texas, on July 22, 1987.
TRD-8706027 Marlin W. Johnston
Commissioner
Texas Department of
Human Services
Proposed date of adoption:
November 2, 1987
For further information, please call
(512) 450.3766.
4f 4 4tSubchapter I. Limitations
*+40 TAC 35.801-35.808
(Editor's note: The text of the following sec-
tions proposed for repeal will not be pub-
lished. The sections may be examined in the
offices of the Texas Department of Human
Services, 701 West 51st Street, Austin, or in
the Texas Register office, Room 503F, Sam
Houston Building, 201 East 14th Street,
Austin.)
The repeals are proposed under the
Human Resources Code, Title 2, Chapters
22 and 32, which provides the department
with the authority to administer public
and medical assistance programs.
35.801. Availability of Funds.
35.802. Prescription Requirements.
35.803. Number-of-Prescriptions Limit.
35.804. Refills.
35.805. Quantity Limitation.
35.806. Pharmacy Services.
35.807. Advertising.
35.808. Freedom of Choice.
This agency hereby certifies that the pro-
posal has been reviewed by legal counsel
and found to be within the agency's
authority to adopt.
Issued in Austin, Texas, on July 22, 1987.
TRD-8706017 Marlin W. Johnston
Commissioner
Texas Department of
Human Services
Proposed date of adoption:
November 2, 1987
For further information, please call
(512) 450-3766.
Subchapter H. Texas Drug Code
Index-Additions, Retentions,
and Deletions
*40 TAC 35.801-35.804
The new sections are proposed under the
Human Resources Code, Title 2, Chapters
22 and 32, which provides the department
with the authority to administer public
and medical assistance programs.
35.801. Application for Addition of
Drugs to the Texas Drug Code Index.
(a) Any drug company may submit an
application to the department for addition
of a drug not currently listed in the Texas
Drug Code Index (TDCI). Drug companies
include any manufacturer, own label distri-
butor, or relabeler.
(b) The drug company must complete
the application form provided by the depart-
ment. All questions on the form must be an-
swered and all statements must be complete.For a multisource drug, the drug company
may reference the actual manufacturer's
data, if the manufacturer's drug is listed in
the TDCI.
(c) Sources other than drug companies
may request the addition of a drug not cur-
rently listed in the TDCI. If the request is
not from a drug company, the department
requests the manufacturer to submit an ap-
plication as described in subsection (b) of this
section.
(d) The drug company and other
sources, if applicable, are entitled to receive
notification of approved or denied applica-
tions. If the application has been denied, the
department states the reasons for the denial.
35.802. Review and Evaluation.
(a) The department reviews each ap-
plication to determine the need for a drug
to be added to the Texas Drug Code Index.
In determining need, the department con-
siders the following:
(1) expansion of the prescriber's ar-
mamentarium by a new drug or an addi-
tional multisource drug;
(2) availability of the drug to phar-
macies in Texas, as evidenced by current use
of the drug by 10% of the providers in the
Vendor Drug Program;
(3) the cost of the drug to phar-
macies compared to:
(A) wholesale estimated acquisi-
tion cost (WEAC) or direct estimated acqui-
sition costs (DEAC) listed in the Redbook
(Annual Pharmacists' Reference); and
(B) other generically equivalent
drug products.
(b) The department may deny an ap-
plication for any of the following reasons:
(1) discovery of false or erroneous
information or documentation on the appli-
cation form;
(2) failure of the drug company to
provide the department with documenta-
tion of the:
(A) approved New Drug Appli-
cation (NDA) or Abbreviated New Drug Ap-
plication (ANDA), if applicable;
(B) Food and Drug Administra-
tion (FDA) approval for marketing; or
(C) compliance with regulations
in Current Good Manufacturing Practice for
Pharmaceuticals (21 Code of Federal
Regulations Part 211), if subparagraph (A)
or (B) does not apply;
(3) failure of the drug company to
provide the department with the National
Drug Code (NDC), as defined by and filed
with FDA, for the drug product as shown
on the drug product container sold to the
pharmacy;
(4) failure of the drug company to
provide the department with the current
DEAC to a pharmacy, cost to a wholesaler,
or estimated wholesale cost to a pharmacy.
The allowable WEAC and DEAC are the
costs to a pharmacy, as determined by review
of published or nonpublished prices resulting
from routine marketing practices;
(5) determination that the drug is.1ul' 28, 1987 Texas Register 4
12 TexReg 2474
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Texas. Secretary of State. Texas Register, Volume 12, Number 57, Pages 2453-2487, July 28, 1987, periodical, July 28, 1987; Austin, Texas. (https://texashistory.unt.edu/ark:/67531/metapth243901/m1/22/: accessed July 16, 2024), University of North Texas Libraries, The Portal to Texas History, https://texashistory.unt.edu; crediting UNT Libraries Government Documents Department.