Part 15.
TEXAS HEALTH AND HUMAN SERVICES COMMISSION
Chapter 354.
MEDICAID HEALTH SERVICES
Subchapter F. PHARMACY SERVICES
The Texas Health and Human Services Commission (Commission) proposes
an amendment to Subchapter F concerning Pharmacy Services. Specifically, the
Commission proposes amendments to §§354.1801, 354. 1802, 354.1804,
354.1807, 354.1809, 354.1811, 354.1815, 354.1831, 354.1837, 354.1861, 354.1863,
354.1867, 354.1871, 354.1873, 354.1892, 354.1901, 354.1905, 354.1907, 354.1911,
354.1921, 354.1923, 354.1925, 354.1927 and the repeal of §§354.1839,
354.1853, 354.1855, 354.1869 and 354.1903. Government Code, §2001.039
requires that each state agency review, and consider for readoption, each
rule adopted by that agency pursuant to the Government Code, Chapter 2001
(Administrative Procedure Act). The Commission has reviewed Subchapter F and
has determined that reasons for adopting the Subchapter continue to exist;
however, changes were necessary as described in this preamble.
The Commission adopted a rule review of Subchapter F in the January 3,
2003, issue of the
Texas Register
(28 TexReg
374). No comments were received due to publication of the notice of intent.
Changes and repeals that are being proposed to several other rules in Subchapter
F as a result of this rule review are being proposed separately.
This section amends provisions relating to the operation of the Vendor
Drug Program. Specifically, language is revised to: reflect the transfer of
the program from the Texas Department of Health to the Commission and transfer
of the rules from Title 25 to Title 1 of the Texas Administrative Code; change
references to forms and delete references to obsolete committees and processes.
The following rules are also being repealed because they have been determined
to be obsolete, or their content has been incorporated into other rules in
this subchapter: Sections 354.1839, 354.1853, 354.1855 and 354.1869 are being
repealed; Section 354.1903 has been repealed and incorporated into §354.1901.
The repeal of §354.1869 was readopted as §354.3047 effective April
21,2002. The current §354.1869, Quantity Limitation, is now obsolete.
In addition, §354.1923 is being proposed with the language repealed from
subchapter W, §354.3092.
Tom Suehs, Chief Financial Officer, has determined that for each year of
the first five years the section is in effect, there will be no fiscal implications
for state and local government as a result of amending the Subchapter as proposed.
Mr. Suehs has also determined that for each year of the first five years
these rules are in effect, the public benefit anticipated as a result of amending
the Subchapter will be to update the references in the rules for accuracy
and clarity. There will be no costs to small business or micro-business resulting
from compliance with these rules as the rules only update and clarify existing
rules. There are no anticipated economic costs to persons who are required
to comply with the rules proposed. There is no anticipated impact on local
employment.
The Commission has determined that the proposal is not a "major environmental
rule" as defined by §2001.0255 of the Texas Government Code. "Major environmental
rule" is defined to mean a rule the specific intent of which is to protect
the environment or reduce risk to human health from environmental exposure
and that may adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment or the public health
and safety of a state or a sector of the state. These rules are not specifically
intended to protect the environment or reduce risks to human health from environmental
exposure.
The Commission has determined that this proposal does not restrict or limit
an owner's right to their property and that would otherwise exist in the absence
of governmental action and therefore does not constitute a taking under §2007.043,
Government Code.
Comments may be submitted to Patricia Gladden, Texas Health and Human Services
Commission, 1100 West 49th Street, Austin, Texas, 78756, or at (512) 794-5163,
within 30 days of publication of this proposal in the
Texas Register
.
1.
PARTICIPATION
1 TAC §§354.1801, 354.1802, 354.1804, 354.1807, 354.1809, 354.1811, 354.1815
The amendments are proposed under the Human Resources Code §32.021
and the Texas Government Code, §531.021, which provides the Commission
with the authority to adopt rules to administer the State's medical assistance
program.
The amendments affect the Human Resources Code, Chapter 32, and the Texas
Government Code, Chapter 531.
§354.1801.Requirements for Participation.
(a)
Any pharmacy or pharmacist who has a current license or
registration with the Texas State Board of Pharmacy or is licensed under the
laws of his respective state and is free from any pharmacy board restriction
may apply to become a provider in this program. Prescribing practitioners
who are authorized and licensed to practice the healing arts, as defined and
limited by federal and state laws, and choose to provide their own pharmaceuticals
may also apply to become providers.
(b)
Except as stated in
§354.1809
[
§354.1802.Applications for Participation.
(a)
Applications for participation must be made to
Texas
Health and Human Services Commission, Vendor Drug Program, Pharmacy Contracts
and Rebates, using the address provided on the cover letter to the application
package.
[
(b)
When an application is approved, the provider or his authorized
representative must enter into a written contract with the
Commission
[
(c)
The
Commission
[
§354.1804.Access to Records.
On request, the provider must allow
Commission
[
§354.1807.Disclosure of Criminal Convictions.
On request, the provider must disclose to the
Commission
[
§354.1809.Termination of Participation.
(a)
The
Commission
[
(b)
The
Commission
[
§354.1811.Provider Sanctions.
(a)
The
Commission
[
(b)
On receipt of a written request, the
Commission
[
§354.1815.Reasons for Placing a Pharmacy on Vendor Hold.
Reasons for placing a pharmacy on vendor hold are as follows:
(1)
violation of the provisions of the Texas Title XIX Vendor
Drug Program contract;
(2)
failure to pay, within the allotted period of time, the
amount of restitution as revealed by the audit of the pharmacy;
(3)
request by the office of the investigator general, when
that office is investigating a pharmacy for possible fraud;
(4)
failure to renew the pharmacy's permit with the Texas State
Board of Pharmacy;
(5)
failure to file a required cost report. Failure by a provider
who is required to file a cost report according to applicable instructions
and within the prescribed time period results in a hold being placed on the
provider's vendor payments. A hold remains in effect until all cost-reporting
deficiencies are corrected. If the cost reporting deficiencies are not corrected
within three months following the due date of the report, the contract of
a provider required to file a cost report may be cancelled. The provider is
notified of contract cancellation when this action is taken. Notice is considered
to have been made as of the date of delivery to the United States Postal Service;
(6)
failure to allow access to financial and other records.
Failure by a provider to allow
Commission
[
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed with the Office of
the Secretary of State on February 24, 2003.
TRD-200301384
Steve Aragon
General Counsel
Texas Health and Human Services Commission
Earliest possible date of adoption: April 6, 2003
For further information, please call: (512) 424-6756
1 TAC §354.1831, §354.1837
The amendments are proposed under the Human Resources Code §32.021
and the Texas Government Code, §531.021, which provides the Commission
with the authority to adopt rules to administer the State's medical assistance
program.
The amendments affect the Human Resources Code, Chapter 32, and the Texas
Government Code, Chapter 531.
§354.1831.Covered Drugs.
(a)
Only those drugs listed in the latest edition of the Texas
Drug Code Index (TDCI)[
(b)
Except for vitamins K and D3, prenatal vitamins, fluoride
preparations, and products containing iron in its various salts, the
Commission
[
(c)
The
Commission
[
§354.1837.Evidence of Eligibility.
Eligible individuals present the medical care identification card to
the vendor each time a prescription is filled. [
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed
with the Office of the Secretary of State on February 24, 2003.
TRD-200301385
Steve Aragon
General Counsel
Texas Health and Human Services Commission
Earliest possible date of adoption: April 6, 2003
For further information, please call: (512) 424-6756
1 TAC §354.1839
(Editor's note: The text of the following section proposed for
repeal will not be published. The section may be examined in the offices of
the Texas Health and Human Services Commission or in the Texas Register office,
Room 245, James Earl Rudder Building, 1019 Brazos Street, Austin.)
The repeal is proposed under the Human Resources
Code §32.021 and the Texas Government Code, §531.021, which provides
the Commission with the authority to adopt rules to administer the State's
medical assistance program.
The repeal affects the Human Resources Code, Chapter 32, and the Texas
Government Code, Chapter 531.
§354.1839.Retention of Eligibility Documents by the Provider.
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed
with the Office of the Secretary of State on February 24, 2003.
TRD-200301390
Steve Aragon
General Counsel
Texas Health and Human Services Commission
Earliest possible date of adoption: April 6, 2003
For further information, please call: (512) 424-6756
1 TAC §354.1853, §354.1855
(Editor's note: The text of the following sections proposed for
repeal will not be published. The sections may be examined in the offices
of the Texas Health and Human Services Commission or in the Texas Register
office, Room 245, James Earl Rudder Building, 1019 Brazos Street, Austin.)
The repeals are proposed under the Human Resources
Code §32.021 and the Texas Government Code, §531.021, which provides
the Commission with the authority to adopt rules to administer the State's
medical assistance program.
The repeals affect the Human Resources Code, Chapter 32, and the Texas
Government Code, Chapter 531.
§354.1853.Authorized Allotments.
§354.1855.Codeine Preparations.
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed
with the Office of the Secretary of State on February 24, 2003.
TRD-200301391
Steve Aragon
General Counsel
Texas Health and Human Services Commission
Earliest possible date of adoption: April 6, 2003
For further information, please call: (512) 424-6756
1 TAC §§354.1861, 354.1863, 354.1867, 354.1871, 354.1873
The amendments are proposed under the Human Resources Code §32.021
and the Texas Government Code, §531.021, which provides the Commission
with the authority to adopt rules to administer the State's medical assistance
program.
The amendments affect the Human Resources Code, Chapter 32, and the Texas
Government Code, Chapter 531.
§354.1861.Availability of Funds.
The
vendor drug program is limited by the availability of
appropriated funds. Services may be adjusted periodically depending on current
availability of funds.
§354.1863.Prescription Requirements.
(a)
Payment for pharmaceuticals can be made only when these
pharmaceuticals are prescribed by a practitioner licensed to prescribe legend
drugs.
(b)
The pharmacist must ensure that the original prescription
conforms to the Texas State Board of Pharmacy rules concerning the records
to be maintained by a pharmacy. A signed prescription must be maintained in
the dispenser's file and available for audit at any reasonable time. Telephone
orders, where legal, must be documented in writing. The name of the
prescriber
[
(c)
The dispensing pharmacist must date the prescription and
initial the refills
§354.1867.Refills.
As many as five refills may be authorized by the prescriber, but the
total amount authorized must be dispensed within six months of the original
prescription. Refills for controlled substances must conform to Drug Enforcement
Administration
[
§354.1871.Advertising.
(a)
No advertising is used to influence a recipient's free
choice of a pharmacy and no advertising is used that, in the opinion of the
Commission,
[
(b)
Advertisements should convey only participation in the
program.
(c)
The sign supplied by the
Commission
[
§354.1873.Freedom of Choice.
Medicaid recipients may obtain pharmaceutical services from any qualified
pharmacy that contracts with the
Commission
[
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed
with the Office of the Secretary of State on February 24, 2003.
TRD-200301386
Steve Aragon
General Counsel
Texas Health and Human Services Commission
Earliest possible date of adoption: April 6, 2003
For further information, please call: (512) 424-6756
1 TAC §354.1869
(Editor's note: The text of the following section proposed for
repeal will not be published. The section may be examined in the offices of
the Texas Health and Human Services Commission or in the Texas Register office,
Room 245, James Earl Rudder Building, 1019 Brazos Street, Austin.)
The repeal is proposed under the Human Resources
Code §32.021 and the Texas Government Code, §531.021, which provides
the Commission with the authority to adopt rules to administer the State's
medical assistance program.
The repeal affects the Human Resources Code, Chapter 32, and the Texas
Government Code, Chapter 531.
§354.1869.Quantity Limitation.
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed
with the Office of the Secretary of State on February 24, 2003.
TRD-200301392
Steve Aragon
General Counsel
Texas Health and Human Services Commission
Earliest possible date of adoption: April 6, 2003
For further information, please call: (512) 424-6756
1 TAC §354.1892
The amendment is proposed under the Human Resources Code §32.021
and the Texas Government Code, §531.021, which provides the Commission
with the authority to adopt rules to administer the State's medical assistance
program.
The amendment affects the Human Resources Code, Chapter 32, and the Texas
Government Code, Chapter 531.
§354.1892.Exception Notification.
The Commission
[
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed
with the Office of the Secretary of State on February 24, 2003.
TRD-200301387
Steve Aragon
General Counsel
Texas Health and Human Services Commission
Earliest possible date of adoption: April 6, 2003
For further information, please call: (512) 424-6756
1 TAC §§354.1901, 354.1905, 354.1907, 354.1911
The amendments are proposed under the Human Resources Code §32.021
and the Texas Government Code, §531.021, which provides the Commission
with the authority to adopt rules to administer the State's medical assistance
program.
The amendments affect the Human Resources Code, Chapter 32, and the Texas
Government Code, Chapter 531.
§354.1901.Pharmacy Claims.
(a)
To receive payment from the
Commission,
[
(b)
Providers must dispense the quantity prescribed or ordered
by the
prescriber
[
(c)
If all necessary information is not supplied, a claim cannot
be processed or paid.
(d)
The provider must submit claims as the prescription is
dispensed through the on-line system; however, some providers who supply a
large volume of medications to nursing facility recipients may submit these
claims through their data transmission company after the point of sale.
(e)
Overcharged prescription claims
are not denied. The appropriate drug cost (wholesale acquisition cost, direct
acquisition cost, or maximum allowable cost) listed in the computer drug file,
plus the provider's assigned dispensing fee, is paid. The amount claimed and
the amount paid are shown on the payment register.
§354.1905.Claim Adjustments.
The pharmacy provider must completely reverse the original submission
and resubmit the claims to receive an adjustment for an overpayment or underpayment
of a pharmacy claim. The
Commission
[
§354.1907.Unacknowledged Claims.
The
Commission
[
§354.1911.Electronic Data Transmission Vendors (Switches).
Providers must use contracted data transmission companies (switches)
to send claims to the
Commission
[
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed
with the Office of the Secretary of State on February 24, 2003.
TRD-200301388
Steve Aragon
General Counsel
Texas Health and Human Services Commission
Earliest possible date of adoption: April 6, 2003
For further information, please call: (512) 424-6756
1 TAC §354.1903
(Editor's note: The text of the following section proposed for
repeal will not be published. The section may be examined in the offices of
the Texas Health and Human Services Commission or in the Texas Register office,
Room 245, James Earl Rudder Building, 1019 Brazos Street, Austin.)
The repeal is proposed under the Human Resources
Code §32.021 and the Texas Government Code, §531.021, which provides
the Commission with the authority to adopt rules to administer the State's
medical assistance program.
The repeal affects the Human Resources Code, Chapter 32, and the Texas
Government Code, Chapter 531.
§354.1903.Overcharged Claims.
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed
with the Office of the Secretary of State on February 24, 2003.
TRD-200301393
Steve Aragon
General Counsel
Texas Health and Human Services Commission
Earliest possible date of adoption: April 6, 2003
For further information, please call: (512) 424-6756
1 TAC §§354.1921, 354.1923, 354.1925, 354.1927
The amendments are proposed under the Human Resources Code §32.021
and the Texas Government Code, §531.021, which provides the Commission
with the authority to adopt rules to administer the State's medical assistance
program.
The amendments affect the Human Resources Code, Chapter 32, and the Texas
Government Code, Chapter 531.
§354.1921.[
(a)
Any drug company that has a valid rebate agreement under
the Social Security Act, §1927, is allowed to
apply
[
(b)
The drug company must complete the
questionnaire
[
(c)
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
[
(d)
The drug company and other sources, if applicable, are
entitled to receive notification of approved or denied
requests
[
§354.1923.Review and Evaluation.
(a)
The Commission reviews each
request to determine the need for a drug to be added to the Texas Drug Code
Index and to determine the need for restrictions, when appropriate. In determining
need, the Commission considers the following:
(1)
Expansion of the prescriber's armamentarium
by a new drug or an additional multisource drug;
(2)
predominant use of the drug in an outpatient
setting;
(3)
the cost of the drug to pharmacies compared
to:
(A)
wholesale estimated acquisition cost (WEAC)
or direct estimated acquisition costs (DEAC) listed in the Redbook (Annual
Pharmacists' Reference);
(B)
the Average Manufacturer's Price (AMP) as defined
by 42 U.S.C. §1396r-8(k), as amended; and
(C)
other generically equivalent drug products.
(b)
The Commission returns a questionnaire
for any of the following reasons:
(1)
discovery of false, erroneous, or incomplete
information or documentation on the questionnaire;
(2)
failure of the drug company to provide the Commission
with documentation of the:
(A)
approved new drug application (NDA) or abbreviated
new drug application (ANDA), if applicable; or
(B)
Food and Drug Administration (FDA) approval
for marketing;
(3)
failure of the drug company to provide the Commission
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 Commission
with the current DEAC to a pharmacy, cost to a wholesaler, estimated wholesale
cost to a pharmacy, or AMP. The allowable WEAC and DEAC are the costs to a
pharmacy, as determined by review of published or non-published prices resulting
from routine marketing practices. The drug company shall update the AMP each
quarter at the same time the information is reported to the Secretary of Health
and Human Services.
(c)
The Commission may deny a request
if it determines that the drug is included in one or more of the following
classes:
(1)
amphetamines, when used for weight loss, and
obesity control drugs;
(2)
appliances;
(3)
cosmetics;
(4)
DESI-ineffective products;
(5)
diagnostic aids;
(6)
durable medical equipment (rental or purchase);
(7)
elastic stockings;
(8)
experimental drugs;
(9)
fertility drugs;
(10)
first aid supplies;
(11)
immunizing agents;
(12)
irrigating sets;
(13)
IV sets;
(14)
medical devices;
(15)
medical supplies;
(16)
oxygen;
(17)
products unsuitable for use outside of physician
offices or health care facilities;
(18)
shampoos, unless medicated for parasite control;
(19)
skin lotions and creams (nonlegend cosmetic
types);
(20)
soaps and soap substitutes;
(21)
supports and suspensories;
(22)
syringes and needles;
(23)
unit-dose or convenience packaging; and
(24)
vitamin and antianemia combinations.
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§354.1925.Resubmittal of a Denied Request [
(a)
Upon initial denial,
[
(b)
If [
§354.1927.Retention and Deletion of Drugs.
(a)
The
Commission
[
(1)
If the drug company fails to remove from pharmacies any
drug recalled by the Food and Drug Administration (FDA) or fails to meet other
federal requirements, the
Commission
[
(2)
If the drug company fails to provide the
Commission
[
(3)
The
Commission
[
(4)
Effective upon notification, the
Commission
[
(A)
drugs permanently recalled by the manufacturer;
(B)
drugs permanently recalled by FDA; and
(C)
drugs no longer manufactured.
(5)
The
Commission
[
(A)
drugs for which a rebate is not available under Public
Law 101-508; and
(B)
drugs for which notice of opportunity for hearing has been
published in the Federal Register.
(b)
If a drug is deleted, the drug company is entitled to be
notified and given an opportunity to request reconsideration of the decision,
unless the deletion is based on criteria in subsection (a)(3)-(5) of this
section. [
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed
with the Office of the Secretary of State on February 24, 2003.
TRD-200301389
Steve Aragon
General Counsel
Texas Health and Human Services Commission
Earliest possible date of adoption: April 6, 2003
For further information, please call: (512) 424-6756
The Texas Health and Human Services Commission (Commission) proposes
amendments to Subchapter F concerning Pharmacy Services. Specifically, the
Commission proposes amendments to §354.1833 and §354. 1891. Government
Code, §2001.039 requires that each state agency review, and consider
for readoption, each rule adopted by that agency pursuant to the Government
Code, Chapter 2001 (Administrative Procedure Act). The Commission has reviewed
Subchapter F and has determined that reasons for adopting the Subchapter continue
to exist; however, changes to these rules were necessary as described in this
preamble.
The Commission published a Notice of Intention to review Subchapter F in
the
Texas Register
on June 28,2002 (27 TexReg
5803). No comments were received due to publication of this notice. The adoption
of this rule review was published in the January 3, 2002, issue of the
This section amends provisions relating to the operation of the Vendor
Drug Program. Specifically, language is revised to: reflect the movement of
these rules from Title 25 to Title 1 of the Texas Administrative Code, change
references to rules and update language resulting from the change in program
responsibility for these rules from the Texas Department of Health to the
Texas Health and Human Services Commission. In addition, §354.1833 has
been updated to clarify that the meaning of dispensing in these rules is the
same as that currently found in the Pharmacy Provider Handbook. §354.1891
has also been updated to make the processes for Vendor Drug Provider audit
resolution more consistent with other Commission processes for provider resolution.
Changes and repeals that are being proposed to several other rules in Subchapter
F as a result of this rule review have been proposed separately.
Tom Suehs, Deputy Commissioner of Financial Services, has determined that
for each year of the first five years the section is in effect, there will
be no fiscal implications for state and local government as a result of amending
the Subchapter as proposed.
Mr. Suehs has also determined that for each year of the first five years
these rules are in effect, the public benefit anticipated as a result of amending
the Subchapter will be to update the references in the rules for accuracy
and clarity; to eliminate any misunderstanding regarding the definition of
Pharmacy Services in the Vendor Drug Program; and to make the processes of
provider resolution more consistent within the Commission. There will be no
costs to small business or micro-business resulting from compliance with these
rules as the rules only update and clarify existing rules, and make them consistent
within the Commission. There are no anticipated economic costs to persons
who are required to comply with the rules proposed. There is no anticipated
impact on local employment.
The Commission has determined that the proposal is not a "major environmental
rule" as defined by §2001.0255 of the Texas Government Code. "Major environmental
rule" is defined to mean a rule the specific intent of which is to protect
the environment or reduce risk to human health from environmental exposure
and that may adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment or the public health
and safety of a state or a sector of the state. These rules are not specifically
intended to protect the environment or reduce risks to human health from environmental
exposure.
The Commission has determined that this proposal does not restrict or limit
an owner's right to their property and that would otherwise exist in the absence
of governmental action and therefore does not constitute a taking under §2007.043,
Government Code.
Comments may be submitted to Patricia Gladden, Texas Health and Human Services
Commission, 1100 West 49th Street, Austin, Texas, 78756, or at (512) 794-5163,
within 30 days of publication of this proposal in the
Texas Register
.
2.
ADMINISTRATION
1 TAC §354.1833
The amendment is proposed under the Human Resources Code §32.021
and the Texas Government Code, §531.021, which provides the Commission
with the authority to adopt rules to administer the State's medical assistance
program.
The amendment affects the Human Resources Code, Chapter 32, and the Texas
Government Code, Chapter 531.
§354.1833.Pharmacy Services.
Under the Vendor Drug Program, pharmacy services include the dispensing
to eligible recipients of covered legend and nonlegend drugs that appear in
the latest revision of the Texas Drug Code Index [
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of
the Secretary of State on February 24, 2003.
TRD-200301397
Steve Aragon
General Counsel
Texas Health and Human Services Commission
Earliest possible date of adoption: April 6, 2003
For further information, please call: (512) 424-6756
1 TAC §354.1891
The amendment is proposed under the Human Resources Code §32.021
and the Texas Government Code, §531.021, which provides the Commission
with the authority to adopt rules to administer the State's medical assistance
program.
The amendment affects the Human Resources Code, Chapter 32, and the Texas
Government Code, Chapter 531.
§354.1891.Vendor Drug Providers Subject to Audit.
(a)
All providers participating in the Vendor Drug Program
are subject to periodic audit. When information from regional pharmacists
or from computerized program management reports indicate a provider may have
deviated from the standards of the Vendor Drug Program, an audit of that provider
is considered top priority. [
(b)
Audits determine provider compliance with the program policies,
procedures, and limitations outlined in these rules and the provider's contract.
Data for transactions selected for audit are compared with data on the corresponding
prescriptions. Erroneous payments and overpayments that occur because of noncompliance
with program requirements are considered exceptions subject to restitution
to the
Commission
[
(c)
If a provider disagrees with the initial findings of an
audit, the provider may present additional documentation to the
Commission's
[
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed
with the Office of the Secretary of State on February 24, 2003.
TRD-200301398
Steve Aragon
General Counsel
Texas Health and Human Services Commission
Earliest possible date of adoption: April 6, 2003
For further information, please call: (512) 424-6756
1 TAC §354.3047
The Texas Health and Human Services Commission (HHSC) proposes
amendments to §354.3047, Quantity Limitations. The proposed amendments
change §354.3047 to limit the reimbursable number of days supply of prescription
drugs to 34 for Medicaid recipients who are allowed an unlimited number of
prescriptions. The amendments also add a minimum reimbursable number of days
supply for most medications. Previously, all Medicaid recipients had been
allowed up to a six-month supply of medication, at the discretion of the prescriber.
Implementation of the 34-day limitation should limit drug waste among Medicaid
recipients who are allowed an unlimited number of prescriptions without preventing
their access to necessary prescriptions. Specific reference to the minimum
days supply should discourage providers from attempting to collect additional
dispensing fees for small quantities of medication.
Tom Suehs, Deputy Commissioner for Financial Services, has determined that,
for the first five years the proposed rule is in effect, there will be an
estimated net savings to the Vendor Drug Program attributable to the reduction
in the reimbursable number of days supply for recipients with unlimited prescriptions.
The increased costs resulting from additional claims and related pharmacy
fees will be offset by larger savings in drug costs attributable to avoidance
of drug waste. Assuming implementation on April 1, 2003, the estimated net
savings (state/federal combined) is anticipated to be $.3 million for FY 03;
$1.8 million for FY 04; $3.5 million for FY 05; $5.6 million for FY 06; and
$8.2 million for FY 07.
For each year of the first five years the proposed section is in effect,
the public benefit resulting will be a reduction in drug waste attributable
to the dispensing of unnecessarily large supplies of medications. There will
also be savings from the prevention of inappropriate payment of additional
fees. In addition, the limitation to approximately a month's supply of medication
is consistent with limitations imposed by many other third party payers. There
is no anticipated impact on small business and micro businesses in order to
comply with the section as proposed; they will not be required to alter their
business practices as a result of the amendments. There are no anticipated
economic costs to persons who are required to comply with the proposed rule.
There is no anticipated impact on local employment. There is no anticipated
impact on local governments.
HHSC has determined that the proposed rule is not a "major environmental
rule" as defined by §2001.0225 of the Texas Government Code. "Major environmental
rule" is defined to mean a rule the specific intent of which is to protect
the environment or reduce risks to human health from environmental exposure
and that may adversely affect, in a material way, the economy, a sector of
the economy, productivity, competition, jobs, the environment, or the public
health and safety of the state or a sector of the state. The proposed rule
is not specifically intended to protect the environment or reduce risks to
human health from environmental exposure.
HHSC has determined that this proposed rule does not restrict or limit
an owner's right to their property that would otherwise exist in the absence
of government action and therefore does not constitute a taking as defined
in §2007.002, Government Code.
Written comments on the proposal may be submitted to Ms. Patricia Gladden,
Senior Policy Analyst, Texas Health and Human Services Commission, 1100 W.
49th Street, Austin Texas, 787856 within 30 days of publication of this proposal
in the
Texas Register
.
The amendment is proposed under Texas Government Code §531.033
which provides the Commissioner of HHSC with broad rulemaking authority; the
Human Resources Code, §32.021, and the Texas Government Code §531.021(a)
which provide HHSC with the authority to administer the federal Medical assistance
(Medicaid) program in Texas.
This amendment affects the Human Resources Code, Chapter 32 and the Texas
Government Code, Chapter 531.
§354.3047.Quantity Limitations.
The quantity of drugs prescribed depends on the prescribing practice
of the prescriber and the needs of the patient.
For recipients with monthly
prescription limitations, the
[
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of
the Secretary of State on February 24, 2003.
TRD-200301395
Steve Aragon
General Counsel
Texas Health and Human Services Commission
Earliest possible date of adoption: April 6, 2003
For further information, please call: (512) 424-6756
Subchapter A. COST DETERMINATION PROCESS
1 TAC §355.114
The Texas Health and Human Services Commission (HHSC) proposes
to amend §355.114, concerning vendor fiscal intermediary payment option,
in its Medicaid Reimbursement Rates chapter. The purpose of the amendment
is to replace references to "vendor fiscal intermediary" with "consumer directed
services" (CDS), in reference to the payment option available to eligible
consumers in the Community Based Alternatives, Community Living Assistance
and Support Services, Deaf-Blind Multiple Disabilities, Medically Dependent
Children, and Primary Home Care programs. The amendment also removes references
to the attendant compensation enhancement participation payment rate, allowing
for expansion of the CDS payment option to other services besides the attendant
services.
The Texas Department of Human Services (DHS) is proposing related policy
in its Chapter 41 in this issue of the
Texas Register
.
Tom Suehs, Deputy Commissioner for Financial Services, has determined that,
for the first five-year period the proposed section will be in effect, there
will be no fiscal implications for state government or local government as
a result of enforcing or administering the section.
Steve Lorenzen, Director, Rate Analysis, has determined that, for each
year of the first five years the section is in effect, the public benefit
anticipated as a result of enforcing the section will be to have the name
of the payment option reflect the types of available services and be consistent
with the name used in approved applicable Medicaid waivers and Medicaid State
Plan amendments. There will be no adverse economic effect on small or micro
businesses as a result of enforcing or administering the section, because
the amendment is technical in nature and does not impact policy. There is
no anticipated economic cost to persons who are required to comply with the
proposed section. There will be no anticipated effect on local employment
in geographic areas affected by this section.
Questions about the content of this proposal may be directed to Carolyn
Pratt at (512) 685- 3127 in HHSC's Rate Analysis Department. Written comments
on the proposal may be submitted to Supervisor, Rules and Handbooks Unit-073,
Texas Department of Human Services E-205, P.O. Box 149030, Austin, Texas 78714-9030,
within 30 days of publication in the
Texas Register
. For further information regarding the proposal or to make the proposal
available for public review, contact local offices of DHS or Carolyn Pratt
at (512) 685-3127 in HHSC Rate Analysis.
Under §2007.003(b) of the Texas Government Code, HHSC has determined
that Chapter 2007 of the Government Code does not apply to this rule. Accordingly,
HHSC is not required to complete a takings impact assessment regarding this
rule.
The amendment is proposed under the Government Code, §531.033,
which authorizes the commissioner of HHSC to adopt rules necessary to carry
out the commission's duties, and §531.021(b), which establishes HHSC
as the agency responsible for adopting reasonable rules governing the determination
of fees, charges, and rates for medical assistance payments under Human Resources
Code, Chapter 32.
The amendment implements the Government Code, §§531.033 and 531.021(b).
§355.114. Consumer Directed Services [
(a)
The
consumer directed services (CDS)
[
(b)
The sum of the payment rate for the contracted
CDS
agency
[
(c)
The
CDS
[
(d)
(No change.)
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of
the Secretary of State on February 21, 2003.
TRD-200301350
Steve Aragón
General Counsel
Texas Health and Human Services Commission
Earliest possible date of adoption: April 6, 2003
For further information, please call: (512) 438-3734
Subchapter G. LEGAL ACTION RELATING TO PROVIDERS OF MEDICAL ASSISTANCE
§35.107
] of this title (relating to Termination of Participation), the
Commission
[
department
] maintains open enrollment for in-state
pharmacies licensed as Class A or C by the Texas State Board of Pharmacy.
Out-of-state pharmacies or pharmacies holding any other class of pharmacy
license may be subject to special application procedures. These procedures
are used to determine how Medicaid recipients benefit from contracts with
specialized pharmacies. Contracts are not granted to applicants unless additional
benefits to the recipient are established.
Vendor Drug Program Provider Enrollment, Texas Department
of Health, 1100 West 49th Street, Austin, Texas 78756-3199.
]
department
] to acquire participating status. The provider
is advised by letter of the effective date of his contract[
, his eligibility
for the delivery fee add-on,
] and his vendor number. A contracted provider
agrees to provide pharmaceutical services to Medicaid recipients in the same
manner and to the same degree as they are provided to the general public.
department
] may enter
into special negotiated reimbursement arrangements with other state or local
entities for purposes of maximizing federal financial participation in state
or locally funded programs. If a state or local entity is unwilling to participate
in this kind of an arrangement, a contract may be denied.
department
], the Texas Attorney General Medicaid Fraud Control Unit, and the Department
of Health and Human Services
or their designees
[
staffs
]
immediate access to the prescription files and to the drug acquisition records
that pertain to the Title XIX Medical Assistance (Medicaid) Program for review
or audit. These staffs must be given access to and a sample of the prescription
files of the provider's non-Medicaid customers to determine the provider's
usual and customary price. The identification of the prescription file may
be removed. The provider must cooperate in regular reviews (general audits
and utilization reviews) of the records of each recipient covered under the
Medicaid program.
department
] or to the United States Department of Health and Human Services
the name of any person who has ownership or controlling interest in, or is
an agent or managing employee of, the pharmacy when that person has been convicted
of a criminal offense related to the person's involvement in any program under
Title V, XVIII, XIX, or XX of the Social Security Act. The provider must also
supply, on request, the ownership, management, control, and business transaction
information required by 42 Code of Federal Regulations
part
455,
subpart
B
[
E
].
department
] reserves
the right to reject any request for participation or to immediately terminate
participation should the provider conduct his pharmaceutical practices in
violation of the criteria of the Title XIX Vendor Drug Program, state or federal
laws, or the ethics adopted by the profession.
department
], on receipt
of written request, provides a contract appeal to the provider if the
Commission
[
department
] suspends or cancels the provider's
participation in the program.
department
] reserves
the right to impose administrative sanctions on a provider who conducts his
pharmaceutical practice in violation of the ethics adopted by the profession,
any applicable federal or state laws, the criteria of the Vendor Drug Program,
or the
Commission's
[
department's
] rules regarding fraud
or abuse involving medical providers. Sanctions include, but are not limited
to, termination or suspension from participation, suspension of payments,
and recoupment of overpayments.
department
] provides a contract appeal to a provider who has had
Commission
[
department
] sanctions placed on him.
department
]
representatives or the attorney general's Medicaid fraud control unit staff
access to financial and other records
pertinent to Medicaid services
[
required to verify cost report information
] results in
the provider's vendor payments being placed on hold. A hold remains in effect
until access to the requested records is allowed. If access to the requested
records is not provided within 31 days of the refusal, a
provider's
contract
[
of a provider required to file a cost report and selected for on-site
audit
] may be cancelled. The provider is notified of contract cancellation
when the action is taken.
2.
ADMINISTRATION
and supplements
] are covered by the program
and are payable. Venosets, catheters, and other medical accessories are not
covered and are not included when claiming for intravenous and irrigating
solutions.
department
] does not reimburse for vitamins and
legend and nonlegend multiple ingredient antianemia products.
department
] may limit
coverage of drugs listed in the TDCI. Procedures used to limit utilization
may include prior approval, cost containment caps, or adherence to specific
dosage limitations recommended by manufacturers. Limitations placed on the
specific drugs are indicated in the TDCI.
Entries in the prescription
record alert the pharmacist to the number of prescriptions a recipient has
received in any given month.
]
3.
MEDICATIONS
4.
LIMITATIONS
prescribing physician
] and the signature of the
dispensing pharmacist must be documented. If a pharmacy maintains prescription
records in a data processing system, a hard copy of the prescription must
be retained on file unless the daily log includes all the information required
in
§351.1901
[
§35.701
] of this title (relating
to Pharmacy Claims). The provider must conform to all regulations issued by
the Drug Enforcement Administration and Texas State Board of Pharmacy concerning
the recording of prescriptions in a data processing system.
Agency
] and Texas State Board of Pharmacy
rules. All refills are counted when determining compliance with the authorized
refill limitation. In the absence of specific refill instructions, the prescription
must be interpreted as not refillable. If a prescription notes specific refill
instructions, any future dispensings must be considered refills of the original
prescription, unless the
prescriber
[
physician
] has
been contacted for authorization to dispense a new supply of medication. If
authorization is granted, a new and separate prescription is prepared.
department
] is designed to or has the effect
of promoting the volume of prescriptions provided under the Vendor Drug Program.
department
] may be used at the discretion of the pharmacy. Announcements of the
participation in the Vendor Drug Program may be made on radio, on television,
in newspapers, or in the media. Bargains, premiums, or other considerations
on prescriptions may not be advertised in any manner that would increase the
provider's volume of Medicaid prescriptions.
department
]
to provide services through the Vendor Drug Program.
5.
AUDITS
Vendor drug policy and audit staff
] advises the vendor by certified letter of the audit results, detailing
the exceptions and requesting payment within 30 days. If restitution is not
received within this time period, a vendor hold is placed on the payment claims.
If the vendor is no longer participating in the program, all unpaid claims
are held and payments are placed on vendor hold until restitution is made.
If no unpaid claims that can be held exist and restitution is not made, the
case is referred [
to the attorney general's office
] for
collection
[
legal
] action.
6.
PHARMACY CLAIMS
department
] the provider must submit a pharmacy claim through the electronic
adjudication system. A separate entry is submitted for each prescription or
refill. For the original dispensing and each subsequent refill, the provider
indicates on the prescription the price and reimbursement method (wholesale
estimated acquisition cost, direct estimated acquisition cost, or maximum
allowable cost) and National Drug Code number (NDC), which is submitted to
the
Commission
[
department
] on the corresponding pharmacy
claim. Claims received over 90 days after the date of service are rejected.
For claims on behalf of an individual who has applied for Medicaid coverage
but has not yet been assigned a recipient number on the date of service, the
filing period does not commence until the date the individual has been assigned
a number. The requirements in
§354.1863
[
§35.402
] of this title (relating to Prescription Requirements) are also waived
for retroactive claims. The provider must ensure, however, that a prescription
for a prior eligibility claim conformed to Texas State Board of Pharmacy and
Texas
Health and Human Services Commission
[
Department of
Health
] regulations on the date of service, or a claim cannot be submitted.
physician
] except as limited by the
policies and procedures described in
the Commission's
[
Texas
Department of Health's
] Pharmacy Provider Handbook. Where actual quantity
dispensed deviates from the
prescribed quantity
[
physicians'
prescription
], the provider must bill for the amount actually dispensed.
The quantity of drugs must be entered in the metric decimal quantity field.
The quantity shown as the metric decimal quantity unit must be calculated
after referencing the pricing unit shown in the Texas Drug Code Index.
department
] must
receive an adjustment within 90 days of the date of adjudication.
Texas Department of Health
] must
receive a request for research on unacknowledged claims within
the 90
day filing deadline.
[
90 days of the date of service
].
Texas Department of Health
(department)
]. The provider is responsible for the information supplied
to the
Commission
[
department
] through the switch.
7.
TEXAS DRUG CODE INDEX--ADDITIONS, RETENTIONS, AND DELETIONS Application for ] Addition of Drugs to the Texas Drug Code Index.
submit an application
] to the
Commission
[
department
] for addition of a drug not currently listed in the Texas Drug Code
Index (TDCI). Drug companies include any manufacturer, own label distributor,
or re-labeler.
application form
] provided by the
Commission to request the addition
of a drug to the TDCI
[
department
]. All questions on the
questionnaire
[
form
] must be answered and all statements
must be complete. For a multi-source drug, the drug company may reference
the actual manufacturer's data, if the manufacturer's drug is listed in the
TDCI.
department
] requests the manufacturer
to submit
the questionnaire
[
an application
] as described
in subsection (b) of this section.
applications
]. If the
requests
[
application
] has
been denied, the
Commission
[
department
] states the
reasons for denial.
(a)
The department reviews each
application to determine the need for a drug to be added to the Texas Drug
Code Index and to determine the need for restrictions, when appropriate. In
determining need, the department considers the following:]
(1)
expansion of the prescriber's armamentarium
by a new drug or an additional multisource drug;]
(2)
predominant use of the drug in an outpatient
setting;]
(3)
the cost of the drug to pharmacies compared
to:]
(A)
wholesale estimated acquisition cost (WEAC)
or direct estimated acquisition costs (DEAC) listed in the Redbook (Annual
Pharmacists' Reference); and]
(B)
other generically equivalent drug products.]
(b)
The department returns an
application for any of the following reasons:]
(1)
discovery of false, erroneous, or incomplete
information or documentation on the application form;]
(2)
failure of the drug company to provide the
department with documentation of the:]
(A)
approved new drug application (NDA) or abbreviated
new drug application (ANDA), if applicable; or]
(B)
Food and Drug Administration (FDA) approval
for marketing; ]
(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.]
(c)
The department may deny an
application if it determines that the drug is included in one or more of the
following classes:]
(1)
amphetamines, when used for weight loss, and
obesity control drugs;]
(2)
appliances;]
(3)
cosmetics;]
(4)
DESI-ineffective products;]
(5)
diagnostic aids;]
(6)
durable medical equipment (rental or purchase);]
(7)
elastic stockings;]
(8)
experimental drugs;]
(9)
fertility drugs;]
(10)
first aid supplies;]
(11)
immunizing agents;]
(12)
irrigating sets;]
(13)
IV sets;]
(14)
medical devices;]
(15)
medical supplies;]
(16)
oxygen; ]
(17)
products unsuitable for use outside of physician
offices or health care facilities; ]
(18)
shampoos, unless medicated for parasite control;
]
(19)
skin lotions and creams (nonlegend cosmetic
types);]
(20)
soaps and soap substitutes; ]
(21)
supports and suspensories; ]
(22)
syringes and needles; ]
(23)
unit-dose or convenience packaging; and ]
(24)
vitamin and antianemia combinations.]
Application ].
If an application
for an addition is denied,
] the drug company may
seek
[
request
] reconsideration of the decision. The request is presented to
the
Commission
[
Vendor Drug Advisory Subcommittee
] for
reconsideration
.
[
and recommendation. The department, however,
retains the right to make the final decision.
]
an application or
] a request for reconsideration
[
of an application
] for an addition is denied, the drug company
may not resubmit the
request
[
application
] for six months.
At its option,
[
The department,
] however,
the Commission
may reconsider a denied
request at any time
[
application
during the six-month period
].
department
] reviews
the Texas Drug Code Index to evaluate the need for retaining or deleting drugs
according to the following criteria.
department
] has
the right to request that Health and Human Services (HHS) allow deletion of
the drug. If the drug company repeatedly fails to meet FDA or other federal
requirements, the
Commission
[
department
] may request
permission to delete all drugs manufactured by the company.
department
] the current drug costs that include the direct
estimated acquisition costs (DEAC) to a pharmacy, the cost to a wholesaler,
the Average Manufacturer's Price (AMP),
and the estimated wholesale
cost to a pharmacy, the
Commission
[
department
] is allowed
to request that HHS allow deletion of the drug. If the
Commission
[
department
] retains a drug for which the cost was not reported, the
Commission
[
department
] establishes the cost. The allowable
wholesale estimated acquisition cost (WEAC) and DEAC are the costs to a pharmacy,
as determined by review of published or nonpublished prices that result from
routine marketing practices.
department
] deletes
a legend drug if the same drug becomes available as an over-the-counter drug.
department
] deletes discontinued or permanently recalled drugs. This
provision applies to:
department
] deletes
drugs for which federal matching funds are no longer available. Federal matching
funds are not available for:
The department presents the request to the Vendor Drug Advisory
Subcommittee for reconsideration and recommendation. The department, however,
retains the right to make the final decision.
]
Subchapter F. PHARMACY SERVICES
and updates
].
For purposes of this chapter, dispensing is defined as preparation, packaging,
compounding and/or labeling the medication. Pharmacy services under this chapter
are limited to dispensing to recipients in outpatient settings.
5.
AUDITS
When a provider withdraws from the program
or there is a change in ownership, an audit of that provider also has high
priority.
]
department
].
department's
] auditor for review. Also, on written request,
the
Commission
[
department
] provides an
opportunity
for audit resolution
[
informal audit review
] for a provider
who wants to [
appeal audit exceptions and to
] present documentation
not available at the time of audit. If the provider still disagrees and wants
to appeal, the
Commission,
[
department
] upon receipt
of written request
to the Manager of Contracts and Rebates
, provides
either an informal
[
a formal
] hearing
or additional
desk review. The Commission must receive the request for an informal hearing
or desk review within 15 calendar days of the provider's receipt of the Commission's
Notice of Overpayment letter. The Manager of the Vendor Drug Program will
appoint reviewers for the informal hearing or desk review at the time the
review is requested.
[
in accordance with department rules and regulations.
]
Subchapter W. PHARMACY LIMITATIONS
The
] Vendor Drug program reimburses
the provider for the prescribed quantity, provided the quantity does not exceed
a six-month supply.
For recipients with access to unlimited prescriptions,
the Vendor Drug program reimburses the provider dispensing a medication for
a quantity that does not exceed a one month (thirty four-day) supply. Except
for medications that may be too unstable to be dispensed as a one month supply,
the Commission requires that the same drug in the same strength be dispensed
no more than once per month.
The dispensing of authorized refills must
be consistent with the prescribed dosage schedule and existing federal and
state laws. To be reimbursed by the Vendor Drug Program, a refill must be
dispensed only after 75% of a previous dispensing of the same prescription
would have been used if taken according to the accompanying prescriber's orders.
A higher percentage limit may be required for a drug that has been determined
to be subject to abuse or overuse. A recipient may obtain an early medication
refill for a justifiable reason. A justifiable reason includes, but is not
limited to, a dosage increase or an anticipated prolonged absence from the
community. The reason must be noted on the prescription. Unless specific authorization
is obtained from the prescriber, breakage, spillage, or loss of a medication
are not considered justifiable reasons. The prescription obtained under this
authorization is considered a new prescription.
Chapter 355.
MEDICAID REIMBURSEMENT RATES Vendor Fiscal Intermediary ] Payment Option.
vendor fiscal intermediary (VFI)
] payment option is made available to
eligible consumers in the Community Based Alternatives (CBA), Community Living
Assistance and Support Services (CLASS), Deaf-Blind Multiple Disabilities,
Medically Dependent Children, and Primary Home Care (PHC) programs.
VFI
] and the payment rate for the consumer
participating in CDS
must not exceed the [
hourly attendant compensation
enhancement participant
] payment rate made to contracted providers in
these programs. The payment rate for the contracted
CDS agency
[
VFI
] is determined by modeling the estimated administrative cost to
carry out the responsibilities of the
CDS agency
[
VFI
].
The payment rate for the consumer is determined by subtracting the contracted
CDS
[
VFI
] payment rate from the [
attendant compensation
enhancement participation
] payment rate made to contracted providers
in these programs.
VFI
] payment rate is paid
to the
CDS agency
[
VFI
] as a percentage of the amount
expended and claimed to the Texas Department of Human Services [
(DHS)
].
Chapter 371.
MEDICAID FRAUD AND ABUSE PROGRAM INTEGRITY