TITLE 1.ADMINISTRATION

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 The following rules are also being repealed because they have been determined to be obsolete, or their content has been incorporated into other rules in this subchapter: Sections 354.1839, 354.1853, 354.1855 and 354.1869 are being repealed; Section 354.1903 has been repealed and incorporated into §354.1901.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 In addition, §354.1923 is being proposed with the language repealed from subchapter W, §354.3092.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 [ §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.

§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. [ Vendor Drug Program Provider Enrollment, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756-3199. ]

(b) When an application is approved, the provider or his authorized representative must enter into a written contract with the Commission [ 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.

(c) The Commission [ 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.

§354.1804.Access to Records.

On request, the provider must allow Commission [ 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.

§354.1807.Disclosure of Criminal Convictions.

On request, the provider must disclose to the Commission [ 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 ].

§354.1809.Termination of Participation.

(a) The Commission [ 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.

(b) The Commission [ 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.

§354.1811.Provider Sanctions.

(a) The Commission [ 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.

(b) On receipt of a written request, the Commission [ department ] provides a contract appeal to a provider who has had Commission [ department ] sanctions placed on him.

§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 [ 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.

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


2. ADMINISTRATION

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)[ 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.

(b) Except for vitamins K and D3, prenatal vitamins, fluoride preparations, and products containing iron in its various salts, the Commission [ department ] does not reimburse for vitamins and legend and nonlegend multiple ingredient antianemia products.

(c) The Commission [ 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.

§354.1837.Evidence of Eligibility.

Eligible individuals present the medical care identification card to the vendor each time a prescription is filled. [ Entries in the prescription record alert the pharmacist to the number of prescriptions a recipient has received in any given month. ]

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


3. MEDICATIONS

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


4. LIMITATIONS

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 [ 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.

(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 [ 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.

§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, [ department ] is designed to or has the effect of promoting the volume of prescriptions provided under the Vendor Drug Program.

(b) Advertisements should convey only participation in the program.

(c) The sign supplied by the Commission [ 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.

§354.1873.Freedom of Choice.

Medicaid recipients may obtain pharmaceutical services from any qualified pharmacy that contracts with the Commission [ department ] to provide services through the Vendor Drug Program.

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


5. AUDITS

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 [ 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.

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


6. PHARMACY CLAIMS

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, [ 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.

(b) Providers must dispense the quantity prescribed or ordered by the prescriber [ 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.

(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 [ department ] must receive an adjustment within 90 days of the date of adjudication.

§354.1907.Unacknowledged Claims.

The Commission [ 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 ].

§354.1911.Electronic Data Transmission Vendors (Switches).

Providers must use contracted data transmission companies (switches) to send claims to the Commission [ Texas Department of Health (department) ]. The provider is responsible for the information supplied to the Commission [ department ] through the switch.

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


7. TEXAS DRUG CODE INDEX--ADDITIONS, RETENTIONS, AND DELETIONS

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.[ Application for ] Addition of Drugs to the Texas Drug Code Index.

(a) Any drug company that has a valid rebate agreement under the Social Security Act, §1927, is allowed to apply [ 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.

(b) The drug company must complete the questionnaire [ 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.

(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 [ department ] requests the manufacturer to submit the questionnaire [ an application ] 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 requests [ applications ]. If the requests [ application ] has been denied, the Commission [ department ] states the reasons for denial.

§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.

[ (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.]

§354.1925.Resubmittal of a Denied Request [ Application ].

(a) Upon initial denial, [ 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. ]

(b) If [ 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 ].

§354.1927.Retention and Deletion of Drugs.

(a) The Commission [ department ] reviews the Texas Drug Code Index to evaluate the need for retaining or deleting drugs according to the following criteria.

(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 [ 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.

(2) If the drug company fails to provide the Commission [ 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.

(3) The Commission [ department ] deletes a legend drug if the same drug becomes available as an over-the-counter drug.

(4) Effective upon notification, the Commission [ department ] deletes discontinued or permanently recalled drugs. This provision applies to:

(A) drugs permanently recalled by the manufacturer;

(B) drugs permanently recalled by FDA; and

(C) drugs no longer manufactured.

(5) The Commission [ department ] deletes drugs for which federal matching funds are no longer available. Federal matching funds are not available for:

(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. [ 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. ]

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


Subchapter F. PHARMACY SERVICES

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 Texas Register (28 TexReg 374).

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 [ 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.

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


5. AUDITS

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. [ When a provider withdraws from the program or there is a change in ownership, an audit of that provider also has high 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 [ department ].

(c) If a provider disagrees with the initial findings of an audit, the provider may present additional documentation to the Commission's [ 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. ]

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


Subchapter W. PHARMACY LIMITATIONS

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 [ 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.

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


Chapter 355. MEDICAID REIMBURSEMENT RATES

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 [ Vendor Fiscal Intermediary ] Payment Option.

(a) The consumer directed services (CDS) [ 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.

(b) The sum of the payment rate for the contracted CDS agency [ 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.

(c) The CDS [ 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) ].

(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


Chapter 371. MEDICAID FRAUD AND ABUSE PROGRAM INTEGRITY

Subchapter G. LEGAL ACTION RELATING TO PROVIDERS OF MEDICAL ASSISTANCE

1. FRAUD OR ABUSE INVOLVING MEDICAL PROVIDERS

1 TAC §371.1627

The Health and Human Services Commission (HHSC) proposes to amend §371.1627, Request for Reinstatement. The proposed amendment is pursuant to fraud or abuse involving medical providers previously enrolled in Texas Medicaid. The proposed amendment refines the request for reinstatement by the medical provider.

The proposed amendment to §371.1627 adds clarification to more accurately reflect the essential components as well as the functional and operational elements of the program for excluded medical providers requesting reinstatement.

Tom Suehs, Deputy Commissioner of Financial Services, has determined that during the first five years that the proposed amendment is in effect, there may be some cost saving for state government as a result of enforcing or administering the section. The anticipated cost savings associated with requests from excluded providers for reinstatement are achieved through the implementation of the proposed amendment, §371.1627. However, the amount, if any, cannot be determined. The proposed amendment to this subchapter will not result in any fiscal implications for local health and human services agencies. Local government will not incur additional costs.

Mr. Suehs has also determined that for each year of the first five years the proposed amendment is in effect, the public will benefit from adoption of the amendment. The anticipated public benefit will be to ensure that inappropriate reinstatements will be reduced by requiring that the excluded provider reimburse the Medicaid Title XIX program for any and all outstanding receivables prior to reinstatement. The proposed amendment does not contain any substantive changes for enrolled providers and is not expected to have any significant impact on access to care.

The proposed amendment may result in additional cost to persons required to comply with the amendment. There is not any anticipated adverse effect on small businesses and micro-businesses as the results of this proposed amendment. HHSC will provide policy notification, information, and assistance to medical providers requesting reinstatement to assure minimal business impact and the success of the proposed amendment.

HHSC has determined that the proposed amendment is not a "major environmental rule" as defined by §2001.0225, Government Code. The proposed amendment is not specifically intended to protect the environment or reduce risks to human health from environmental exposure.

HHSC has determined that the proposed rule amendment does not restrict or limit an owner's right to his or her property that would otherwise exist in the absence of governmental action and, therefore, does not constitute a taking under §2007.043 Government Code.

Comments on the proposal may be submitted to Tim Broadhurst, Assistant Director, Office of Investigations & Enforcement, Texas Health and Human Services Commission, PO Box 13247, Austin, Texas 78711-3247 or by telephone at 512-482-3311 within 30 days of publication of this proposal in the Texas Register .

The amendment is proposed under the Texas Government Code, §21531.033, which provides the Commissioner of HHSC with broad rulemaking authority; and under the Human Resources Code, §32.021 and the Government Code §531.021(a), which provide HHSC with the authority to administer the federal medical assistance Title XIX Medicaid program in Texas.

The proposed amendment affects the Texas Government Code, Chapter 531, and Chapter 32 of the Human Resources Code.

§371.1627.Request for Reinstatement.

After the exclusion period specified by the Health and Human Services Commission (HHSC) [ department ], the provider or entity may request reinstatement as specified in the notification letter. The HHSC [ department ] determines the need for individual provider participation or reinstatement. The request for reinstatement could result in a denial by the HHSC [ department ]. This determination is based on the following criteria:

(1) accessibility of other health care to the recipient population; and

(2) the provider's previous conduct, including conduct during participation in the Titles XVIII, XIX, XX, and V programs in any state, or any conduct or action for which a sanction could have been taken, as described in these sections or §371.1620 [ §371.1627 ] of this title (relating to Grounds for Fraud Referral and Administration Sanctions) or §371.1663 [ §79.2402 ] of this title (relating to Liability).

(3) prior to enrollment or re-enrollment in the Medical Assistance Program (Medicaid Title XIX) and/or the Children with Special Health Care Needs Program under the same or different provider number or provider affiliation, the provider will reimburse the Medicaid Title XIX program for any and all outstanding receivables. A provider may not enroll or re-enroll in the program if previous outstanding accounts receivable exist. At the discretion of the HHSC, a payment plan not to exceed 12 months may be offered.

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-200301396

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