NOTICE OF OPEN ENROLLMENT

FOR

NEWBORN SCREENING BENEFITS (NBS)

OE# HHS0000028

Issued:June 19, 2012

Closes: August 31, 2018

NEWBORN SCREENING UNIT

Dr. David L. Lakey

Commissioner

TABLE OF CONTENTS

I. INTRODUCTION AND DEFINITIONS

A. Introduction

B. Definitions

II. LIMITATIONS

III. FUNDING AND TERM

A. Use of Funds

B. Term of Contract

IV. ELIGIBLE APPLICANTS AND REQUIRED ACTIVITIES

A. Eligibility Requirements

B. Required Activities

V. PROGRAM INFORMATION

A. Scope of Work

B. Legal Authority

C. Program Requirements

D. Method of Payment

VI. PROCUREMENT AND ADMINISTRATIVE REQUIREMENTS

A. Submission

B. Evaluation Process

C. Rejection of Enrollment Applications

D. Right to Amend or Withdraw OE

E. Authority to Bind DSHS

F. Financial and Administrative Requirements

G. Contracting with Subcontractors

H. Contract Information

VII. APPLICATION INSTRUCTIONS AND CRITERIA FOR ACCEPTANCE

VIII. BLANK FORMS AND INSTRUCTIONS

FORM A: Face Page

FORM B: Newborn Screening Benefits Open Enrollment Application

FORM B-1: Medical Provider

Medical Provider Continuation

FORM B-2: Laboratory Provider

FORM B-3: Pharmacy Provider

FORM B-4: Low-Protein Food Provider

FORM C: Contact Person Information Form

FORM D: Exceptions Form

IX. APPENDIX

Appendix A: GENERAL PROVISIONS (Core/Vendor)

Appendix B: NEWBORN SCREENING BENEFITS PROGRAM MANUAL

I. INTRODUCTION AND DEFINITIONS

A. Introduction

The Department of State Health Services (DSHS or Department)Newborn Screening (NBS) Unitannounces this notice of Open Enrollment (OE) requesting applications from eligible applicants to provide services to eligible clients in accordance with the Newborn Screening (NBS) Program rules, 25 Texas Administrative Code (TAC) §§37.51-37.65. This OE is not limited to this source of funding if other sources become available for this Project.

This OE contains standardized requirements that all applicants must meet to be considered for contracts under this OE. Failure to comply with these requirements will result in disqualification of the applicant without further consideration. Each applicant is solely responsible for the preparation and submission of anenrollment application in accordance with instructions contained in the OE.

If web links in this document do not open, copy and paste them into your internet browser window.

READ ALL MATERIALS BEFORE COMPLETING THIS OE.

B. Definitions

Appendix – Additional information and/or forms that are available in the back of this solicitation document.

Applicant – A person or entity that submits a response to a solicitation. For purposes of this document, “applicant” is intended to include such phrases as “offeror”, “applicant”, “bidder”, “responder”, or other similar terminology employed by DSHS (or HHSC) to describe the person or entity that responds to a solicitation.

Budget Period – The duration of the budget (stated in the number of months the contract will reflect from begin date to end date of the term of the contract). Each renewal will have its own budget period.

Client Services Contracting Unit –Central contracting unit within DSHS that is responsible for statewide client services procurements and their certifications. CSCU oversees, coordinates, and assists the Division with client services procurement needs, issues competitive procurements, finalizes development, and executes contracts. CSCU maintains the official contract file from procurement to contract closeout.

Contract – A written document referring to promises or agreements for which the law establishes enforceable duties and remedies between a minimum of two parties. A DSHS contract is assembled using a core contract (base), one or more program attachments, and other required exhibits (general provisions, etc.).

Contract Term – The period of time during which the contract or program attachment will be effective from begin date to end, or renewal date. The contract term may or may not be the same as the budget period.

Debarment – An exclusion from contracting or subcontracting with state agencies on the basis of cause set forth in Title 34, Texas Administrative Code Chapter 20, Subchapter C, §20.105 et seq.

Deliverables – Goods or services contracted for delivery or performance.

Due Date – Established deadline for submission of a document or deliverable.

Effective Date – The date the contract term begins.

Fully Executed – When a contract is signed by each of the parties to form a legal binding contractual relationship. No costs chargeable to the proposed contract will be reimbursed before the contract is fully executed.

Program – Depending upon the context, either a coordinated group of activities carried out by DSHS, as authorized by state or federal law, for a specific purpose (“program”) or DSHS staff located in a program, region, or hospital that identify and request procurement needs (“Program”) The Program partners with CSCU on procurements.

A coordinated group of activities carried out by DSHS, as authorized by state or federal law, for a specific purpose.

Program Attachment – An attachment to the contract that provides details for a particular statement of work to be performed under the contract such as services to be delivered, performance measures or deliverables, funding, and reporting requirements. There may be multiple program attachments associated with a core contract. A program attachment is typically for a one-year term, with a contracting cycle made up of several one-year program attachment renewals.

Project Manager– DSHS Division employee responsible being the liaison between a program and CSCU. The project manager partners with CSCU in the development, management and logistical coordination of a solicitation and the resultant contracts.

Project Period – The anticipated duration of the entire Project stated in total number of budget periods.

Scope of Work – A description of the services and/or goods, if any, for each service type, to be obtained as a result of this solicitation for a project period. The scope of work is a document written in the early stages of procurement to explain what DSHS plans to purchase.

Solicitation – The process of notifying prospective contractors of an opportunity to provide goods or services to the state (e.g., OE).

Special Provisions – Modifications and additions to the General Provisions for a funded program activity; which are usually customized for the Program’s requirements and contain provisions specific to the program attachment.

Statement of Work – A part of the contract that describes the services and/or goods to be delivered by the DSHS contractor specifying the type, level and quality of service,thatdirectly relate to program objectives.

Subcontractor – A written agreement between the DSHS contractor and a third party to provide all or a specified part of the services, goods, work, and materials required in the original contract. The contractor remains entirely responsible to DSHS for performance of all requirements of the contract with DSHS. The contractor must closely monitor the subcontractor’s performance. Subcontracting can be done only when expressly allowed in the program attachment.

Supplant (verb) - To replace or substitute one source of funding for another source of funding. A recipient of contract funds under an OE must not use the funds to pay any costs that the recipient is already obligated to pay. If a contractor, prior to responding to an OE, had committed to provide funding for activities defined in the contract’s statement of work (i.e., as represented in the OE Budget Summary), then the contractor must provide the amount of funding previously committed in addition to the amount requested under the OE.

Vendor – A type of contractor or subcontractor that provides services, and goods, if any,that assist in, but are not the primary means of, carrying out the DSHS-funded program. Under avendor contract, the vendorwill have few if any administrative requirements. (For example, a vendor might be required only to submit a summary report of services delivered and an invoice.) A vendor generally will deliver servicesto DSHS-funded clients in the same manner the vendor would deliverthose servicesto its non-DSHS-funded clients.

A vendor contractor generally has most of the following characteristics: a) provides goods and services within normal business operations, b) provides similar goods and services to many different purchasers, c) operates in a competitive environment, d) is not subject to compliance requirements of the federal or state program, e) provides goods and services that are ancillary to the operation of the program. Note: Characteristics a, b, c, and d do not apply to vendor contractors that are universities.

Vendor Identification Number (Vendor ID No.) – Fourteen-digit number needed for any entity, whether vendor or subrecipient, to contract with the State of Texas and which must be set up with the State Comptroller’s Office. It consists of a ten-digit identification number (IRS number, state agency number, or social security number) +check digit + 3 digit mail code. The Vendor ID No. includes all the numbers in the TINs (defined above), including a three digit mail code for a total of 14-digits.

Newborn Screening Benefits Program

Additional Definitions

Diagnosis – Adisorder that has been confirmed to be present in a patient based on clinical evaluation and additional testing including any of the following, as necessary, laboratory testing (blood, urine, or tissue tests), physiologic tests or radiologic exams.

Diagnostic Services– Laboratory studies or tests, x-rays and other appropriate services, ordered by the patient’s health care practitioner(s) to evaluate an individual’s health status for diagnostic purposes.

Dietary Supplement – Dietary supplement is a preparation intended to supplement the diet and provide nutrients, such as vitamins, minerals, fiber, fatty acids, or amino acids, that may be missing or may not be consumed in sufficient quantities in a person's diet. It is intended to be taken by mouth as a pill, capsule, tablet, or liquid; and is labeled on the front panel as being a dietary supplement.

Low Protein Foods – Modified foods low in protein.

Medications – A substance or preparation used in treating disease. Medications can be used for maintenance of health and the prevention, alleviation, or cure of disease.

Prescription Drugs and Devices and Durable Supplies– Medically-necessarypharmaceuticals, medical supplies (capable of withstanding wear) needed for thetreatment of a diagnosed condition.

Remediation Services– Remediation services includes prescriptions for medications, vitamins, dietary supplements and/or low-protein foods deemed necessary for the treatment and management of the diagnosed disorder.

Texas Resident–An individual who resides within the geographic boundaries of thestate is considered a Texas resident.

Treatment – Any specific procedure used for the management of a disease orpathological condition.

Vitamins - Vitamins are compounds that are necessary for growth and health. They are needed in small amounts only and are usually available in a person’s diet.

II. LIMITATIONS

Issuance of this OE in no way constitutes a commitment by DSHS or the State of Texas to execute a contract or to pay any costs incurred by any applicant who may submit an enrollment application.

The resulting contract will be subject to the availability of state or federalfunds. Contracts awarded under this OE and any anticipated contract renewals are contingent upon the continued availability of funding. DSHS reserves the right to alter, amend or withdraw this OE at any time prior to the execution of a contract if funds become unavailable through lack of appropriations, budget cuts, transfer of funds between programs or agencies, amendment of the appropriations act, health and human services agency consolidations, or any other disruption of current appropriations. If a contract has been fully executed and these circumstances arise, the provisions of the Termination Article in the contract will apply.

III. FUNDING AND TERM

A. Use of Funds

Funds are awarded for the purpose specifically defined in this OE and must not be used for any other purpose.

Contractors will be paid for allowable services to eligible clients at established rates as stated in the NBS Benefits Program Contractor Procedures Manual, as funding allows. Eligibility requirements, allowable services and reimbursement rates are included in the NBS Benefits Program Contractor Procedures Manual at

B. Term of Contract

It is expected that the initial contract termwill begin no sooner than09/01/12, and will be made for a 12-monthbudget period. This contract may be renewed up to 5 additional one year period(s), with renewal initiatedat the sole discretion of DSHS. Continued renewal of the contract in future years iscontingentupon the availability of funds and the satisfactory performance of the contractor during the prior contract period. Pricing may vary and is subject to change each renewal.

IV. ELIGIBLE APPLICANTS AND REQUIRED ACTIVITIES

A. Eligibility Requirements

Eligible applicants include Texas medical providers, who are currently enrolled as Medicaid Providers, certified laboratories that provide confirmatory testing and follow-up testing for disorders identified through the DSHS NBS Program, pharmacies that provide medications, vitamins, and dietary supplements prescribed by health care providers specializing in metabolic, endocrine, and hematologic disorders, necessary for treatment and management of diagnosed disorders, and manufactures or retailers of low-protein foods that are specially formulated and intended for the dietary management of a disorder identified by the DSHS NBS Program for individuals with distinctive nutritional needs that cannot be met by normal diet aloneand must comply with the criteria listed below.

  1. Applicant must be established as an appropriate legal entity as described in the paragraph above, under state statutes and must have the authority and be in good standing to do business in Texas and to conduct the activities described in the OE.
  2. Applicant must have a Texas address. A post office box may be used when the enrollment application is submitted, but the applicant must conduct business at a physical location in Texas prior to the date that the contract is awarded.
  3. Applicant must be in good standing with the U.S. Internal Revenue Service.
  4. Applicant is ineligible to apply for funds under this OE if currently debarred, suspended, or otherwise excluded or ineligible for participation in Federal or State assistance programs.
  5. Applicant’s staff members, including the executive director, must not serve as voting members on their employer’s governing board.
  6. In compliance with Comptroller of Public Accounts and Texas Procurement and Support Services rules, a name search will beconducted using the websites listed in this sectionprior tothedevelopment of a contract.

Anapplicant is not considered eligible to contract with DSHS if a namematch is found on any of the following lists:

  1. The Excluded Parties List System (EPLS) – Federal at
  2. The Office of Inspector General (OIG) List of Excluded Individuals/Entities Search– State – and
  3. Texas Comptroller of Public Accounts (CPA) Debarment List located at debarred/.

Additional Eligibility Requirements

  1. Medical Providers

To qualify for enrollment in the NBS Benefits Program, all medical providers must be currently enrolled as Medicaid Providers.

Medical Providers may be:

  • Board certified/board eligible physicians (may also be an active candidate of the American Board of Medical Geneticist) in Medical Biochemical Genetics or Clinical Biochemical Genetics. Clinical Geneticists are eligible and should be active in the management of patients with inborn errors of metabolism at least 25% of their time two years prior to submitting an application for enrollment;
  • Board certified/board eligible Adult and Pediatric Endocrinologists (Adult Endocrinology, Diabetes, Metabolism, or Pediatric Endocrinology);
  • Board certified/board eligible Adult and Pediatric Hematologists (Adult Hematology/Oncology or Pediatric Hematology/Oncology); or
  • Board certified/board eligible Adult and Pediatric Pulmonologists (Adult Pulmonology or Pediatric Pulmonology).
  1. Laboratories

To qualify for enrollment in the NBS Benefits Program, a laboratory must:

  • Be Clinical Laboratory Improvement Amendments(CLIA) certified and must provide a copy of their CLIA certification with their completed application;
  • Have capacity to conduct confirmatory testing and follow-up testing for individuals identified through the Texas Newborn Screening Program as being at risk for a hereditary metabolic, endocrine, or hematologic disorder.
  1. Pharmacies

To qualify for enrollment in the NBS Benefits Program, pharmacies must:

  • Be a Class A (may include compounding pharmacies), Class C (institutional), Class D (clinical), or Class E (mail-order). Evidence of licensure must be provided with the enrollment application
  1. Manufactures or retailers of low-protein foods

To qualify for enrollment in the NBS Benefits Program, providers of low-proteinfoods must:

  • Be manufacturers or retailers of low-protein foods.
  • Supply their Tax ID Number and their License/Permit Numbers (if appropriate).

Except as expressly provided in A.2. above, applicant is not considered eligible to apply unless the applicant meets the eligibility requirements to the stated criteria listed above at the time the enrollment application is submitted. Applicant must continue to meet these conditions throughout the selection and funding process. DSHS expressly reserves the right to review and analyze the documentation submitted and to request additional documentation, and determine the applicant’s eligibility to compete for the contract award.

B. Required Activities

Contractor must:

NBS Benefits contractors shall provide one or more of the following:

  • clinical services to include evaluation and management of metabolic, endocrine, and hematological disorders, diagnostic laboratory tests, and follow-up care;
  • confirmatory testing and follow-up testing; and
  • remediation services, including dietary supplements, low-protein foods, medications, and vitamins.

The NBS Benefits Program will provide reimbursement to enrolled providers for allowable services to eligible clients. Client eligibility requirements, allowable services and reimbursement rates are included in the NBS Benefits Program Contractor Procedures Manual

Contractorshall abide by applicable federal and state laws, regulations, and rules relating to activities listed above.

V. PROGRAM INFORMATION

A. Scope of Work

The Department of State Health Services (DSHS) is authorized by 25 Texas Administrative Code, §§37.51-37.65, to administer Newborn Screening (NBS) benefits through its NBS Benefits Program to eligible Texas clients who have any heritable congenital disorder detected through the program. Eligible clients shall meet the following criteria:

  1. Have a positive presumptive screen of a disorder screened by the NBS Program, or a confirmed diagnosis of any heritable congenital disorder included among those screened by the DSHS NBS Program;
  2. Be a bona fide resident of Texas;
  3. Have a family income at or below 350% of the most current Federal Poverty Income Level (FPL);
  4. If required, make financial participation payments in a timely manner;
  5. Provide updated medical, financial, and residency information and/or documentation upon request;
  6. Identify a parent, managing conservator, or guardian who agrees to abide by these eligibility requirements if the client is a minor; and
  7. Be ineligible for Medicaid, Children with Special Health Care Needs, Children’s Health Insurance Program (CHIP), CHIP Perinatal Program (CHIPPP), Title V Genetic Services, or private insurance that would reimburse all or part of the services.

To be eligible to receive remediation services, including low-protein foods, dietary supplements, medication and vitamins, as well as follow-up care, the client must have a confirmed diagnosis of a disorder screened by the NBS Program, and continue to meet the eligibility criteria in #2-7 listed above.