CN-640000-CL057-1.pdf

Comprehensive Sterilization Services

03/11/2020 1 Contract No: _CL057

Attachment I

A. Services to be Provided:

1. General Description:

a. General Statement: This contract is for the provision of sterilization services for clients who have been counseled, provided informed consent, and are referred to Provider by the Department.

b. Authority:

1) Federal Law: Title X of the Public Health Service Act of 1970, Public Law 91-572, Population Research and Voluntary Family

Planning Programs.

2) Federal Regulation: 42 CFR Part 50, Subpart B, Sterilization of

Persons in Federally Assisted Family Planning Projects.

3) Section 381.0051, Florida Statutes, Comprehensive Family

Planning Act.

4) Section 458.320, Florida Statutes, Financial Responsibility.

5) Federal Regulation: 42 CFR Part 59.15, Maintenance of Physical and Financial Separation.

2. Definition of Terms

a. Federal Sterilization Regulations: Federal requirements and standards that regulate all sterilization procedures performed or arranged by programs and supported in whole or in part by federal financial assistance. See Exhibit A.

b. Informed Consent: Permission granted with the knowledge of the possible consequences, typically given by a patient to a doctor for treatment with full knowledge of the possible risks and benefits.

c. Medical Complications: An abnormal outcome or accident affecting the prognosis of the original outcome.

d. Sterilization: A medical or surgical procedure which leaves the male or female client permanently incapable of reproduction.

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3. Clients to be Served: Persons who are at least 21 years old at the time the informed consent form is signed and who have been referred by the Department to Provider.

B. Manner of Service Provision:

1. Scope of Work: Provider will provide sterilization services to clients referred to it by the Department.

a. Tasks. Provider will perform the following tasks:

1) Comply with Federal Regulation 42 CFR 59.5(a)(2), by furnishing services without subjecting individuals to any coercion to accept services or to employ or not to employ any particular methods of family planning. Ensure that acceptance of sterilization services is solely on a voluntary basis and not made a prerequisite to eligibility for, or receipt of, any other services or assistance from or participation in any other program of Provider.

2) Comply with Federal Regulation 42 CFR Part 50, Subpart B, as outlined in Exhibit A, to determine client eligibility for sterilization services.

3) Coordinate with the Department so that the informed consent process and performance of the sterilization procedure meet federal regulation timeframes, as outlined in Exhibit A.

4) Provide sterilization services only to those clients who have signed an informed consent form at least 30 days, but not greater than

180 days, before the date of the sterilization, except in the case of premature delivery or emergency abdominal surgery.

5) Provide sterilization services only to those clients who are at least

21 years old at the time the informed consent form is signed.

6) In the case of emergency abdominal surgery, deliver sterilization services only to those clients who have given consent to be sterilized and where at least 72 hours have passed since the client signed the informed consent form for sterilization.

7) In the case of premature delivery, provide sterilization services only to clients who have given consent to be sterilized by signing the informed consent form at least 30 days before the expected date of delivery, and where at least 72 hours have passed since the client signed the informed consent form for sterilization.

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8) Perform at least one pre-procedure evaluation office visit per client to determine if the client is medically cleared to proceed with having a sterilization procedure.

9) Document client consent and determine when the sterilization services may be performed using the client’s completed informed consent form, Exhibit B.

10) On the date a procedure is to be performed, check the dates on the informed consent form to ensure the required timeframes regarding the client’s signature are in compliance with Federal

Sterilization Regulations, as outlined in Exhibit A.

11) If the client is medically cleared, perform the sterilization procedure and necessary follow-up, including one post-procedure evaluation office visit.

12) After performing the sterilization, the "Physician’s Statement" portion of the informed consent form, Exhibit B, must be completed, signed, and dated verifying that the eligibility requirements were met prior to performing the sterilization procedure.

13) Should medical complications occur, provide medical care and any referrals deemed medically necessary.

14) All medical complications must be reported to the Department’s

Contract Manager in writing within 10 days of the medical complication.

15) Within 30 days following the completion of the sterilization procedure, the following information must be submitted to the

Department’s Contract Manager and maintained in the client’s health record:

a) A copy of the client’s informed consent form, with all information completed, including the completed

“Physician’s Statement” portion of the consent form, Exhibit B.

b) Written documentation providing a detailed description of the procedure performed which will consist of a final written surgical report, progress notes from the medical record, or equivalent documentation as agreed to by the

Department’s Contract Manager.

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16) Collect fees from third parties legally obligated to pay for sterilization services prior to billing the Department for services provided through this contract. This includes the submission of all information and completed consent forms for Medicaid reimbursement for eligible clients. Fees or donations may not be collected from clients who are provided sterilization services through this contract.

17) Maintain documentation of all visits and tests including, but not limited to, the written surgical report describing the procedure, surgical method used, follow-ups (lab reports, etc.), and any significant findings or adverse reactions the client has experienced.

18) Maintain a copy of Section 1008, Title X, Public Health Service Act of 1970 (Public Law 91-572) which prohibits use of Title X funds in programs where abortion is a method of family planning throughout the contact term.

19) Maintain a copy of 42 CFR 59.5(a)(2), federal regulations governing Title X throughout the contract term.

b. Deliverables: Provider must complete and submit the following

Deliverable in the time and manner specified:

1) Completed sterilization procedures performed in the time and manner specified in Tasks B.1.a.1) through B.1.a.19), with all required documentation submitted.

c. Performance Measures: Deliverable B.1.b.1) must be met at the following minimum level of performance:

1) Federal Regulation 42 CFR 59.5(a)(2), must be complied with as specified.

2) Federal Regulation 42 CFR Part 50, Subpart B, must be complied with as specified.

3) The informed consent process and performance of the sterilization procedure must meet federal regulation timeframes as specified.

4) Sterilization services must only be provided to clients who have signed an informed consent form as specified.

5) Sterilization services must only be provided to clients who are at least 21 years old at the time the informed consent form is signed as specified.

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6) At least one pre-procedure evaluation office visit must be performed for each client as specified.

7) At least one post-procedure evaluation office visit must be performed for each client who receives a sterilization.

8) The "Physician’s Statement" portion of the informed consent form, must be completed as specified.

9) Necessary medical care and referrals must be provided as

10) All medical complications must be reported to the Department’s

Contract Manager as specified.

11) Fees must be collected from third parties legally obligated to pay for sterilization services as specified.

12) Documentation of all visits and tests must be maintained for each client as specified.

2. Financial Consequences: If Provider does not provide a Deliverable in the time and manner specified in Section B.1.b., the following financial consequences will be assessed:

a. Failure to comply with Federal Regulation 42 CFR 59.5(a)(2), as specified will result in a _2%_ reduction from the invoiced amount.

b. Failure to comply with Federal Regulation 42 CFR Part 50, Subpart B, as specified will result in a _2%_ reduction from the invoiced amount.

c. Failure to meet the informed consent process and performance of the sterilization procedure within the federal regulation timeframes as specified will result in a _2%_ reduction from the invoiced amount.

d. Failure to provide sterilization services only to clients who have signed an informed consent form as specified will result in a _2%_ reduction from the invoiced amount.

e. Failure to provide sterilization services only to clients who are at least 21 years old at the time the informed consent form is signed as specified will result in a _2%_ reduction from the invoiced amount.

f. Failure to perform at least one pre-procedure evaluation office visit for each client as specified will result in a _2%_ reduction from the invoiced amount.

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g. Failure to perform at least one post-procedure evaluation office visit for each client who receives a sterilization will result in a _2%_ reduction from the invoiced amount.

h. Failure to complete the "Physician’s Statement" portion of the informed consent form as specified will result in a _2%_ reduction from the invoiced amount.

i. Failure to provide necessary medical care and referrals as specified will result in a _2%_ reduction from the invoiced amount.

j. Failure to report all medical complications to the Department’s Contract

Manager as specified will result in a 2%__ reduction from the invoiced amount.

k. Failure to collect fees from third parties legally obligated to pay for sterilization services as specified will result in a _2%_ reduction from the invoiced amount.

l. Failure to maintain documentation of all visits and tests for each client as specified will result in a 2%__ reduction from the invoiced amount.

3. Service Delivery Location and Equipment

a. Service Delivery Location

The sterilization services will be provided at the following location(s):

Surgery Center of Naples

11161 Health Park Blvd

Naples, Fl 34110

Facilities in which the services are provided must be maintained in conformance with the standards required by local, state, and federal laws and regulations. Provider will notify the Department’s Contract Manager in writing 10 days prior to providing services in another location.

A Title X subrecipient must be organized so that it is physically and financially separate from a facility or entity that offers services that are prohibited under section 1008 of the Public Health Act and 42 CFR 59.13, .14 and .16. Prohibited activities include performing, promoting, referring for, or supporting abortion as a method of family planning. (See 42 CFR

59.14.) In order to be physically and financially separate, a subrecipient must have an objective integrity and be independent from a facility or entity offering prohibited services, with distinctly separate accounting and electronic or paper-based health care records; phone numbers; email

03/11/2020 7 Contract No: _CL057 addresses; educational services, and websites. In addition, facilities of a subrecipient such as treatment, consultation, examination and waiting rooms, office entrances, workstations, signage and other forms of identification must be physically separated and distinctly divided from any facility or entity offering prohibited services. (See Federal Regulation 42

CFR 59.15.)

b. Service Times

1) Provider will perform the services required by this contract at times that meet the needs of the clients, which may include unanticipated premature delivery and emergency abdominal surgery.

2) Provider will have 24-hour emergency services accessible.

Provider will give the Department and the client the information necessary to access these emergency services before, or during, the client’s first visit.

3) Federal Regulation 42 CFR 59.15, must be complied with as

c. Equipment

Provider will furnish all equipment needed to perform services under the terms of this contract.

4. Staffing Requirements

a. Staffing Levels

Provider must maintain sufficient staff to deliver the sterilization services for referred clients.

b. Professional Qualifications

1) The physician performing the sterilization procedure and all staff required by Florida Statutes to have a license to practice must have the requisite Florida-issued professional license, which is current and active. All health care professionals must have experience in the area of the procedure they are performing and practice according to the constraints of their individual practice, licenses, acts, statutes, rules, and protocols.

2) All medical staff providing services under this contract will provide adequate liability insurance or other form of acceptable financial

03/11/2020 8 Contract No: _CL057 responsibility coverage on a comprehensive basis, and will maintain such liability insurance or other form of financial responsibility coverage at all times during the existence of the contract.

3) Copies of documentation must be provided to the Department upon request.

c. Subcontractors

Provider may not subcontract any of the services and/or activities in this contract, without prior written approval from the Department.

Federal Regulation 42 CFR 59.15, must be complied with as specified.

C. Method of Payment

1. Payment: This is a fixed price unit cost contract. The Department will pay for the delivery of service units provided in accordance with the terms of this contract for a total dollar amount not to exceed $__7500______, subject to the availability of funds.

a. The service unit, the unit price, and the maximum number of units allowed are specified below:

Maximum # of Total

Service Unit Unit Price

Units_20__

(services)

Male

Sterilization ________ x ($_______) = ________

Female

Sterilization ___20_____ x ($_375______) = _7500_______

b. Payment will be made only for completed sterilizations unless the client is found medically unable to proceed with the sterilization. A completed sterilization consists of a pre-procedure office visit, the sterilization procedure performed as provided in Section B.1., and appropriate documentation provided to the Department’s Contract Manager.

Payment of the unit price is contingent upon services being provided and required documentation being submitted. The unit prices specified include the cost of any post-procedure office visit provided.

c. If a client is referred, but is medically unable to proceed with the sterilization or does not return for the sterilization procedure after the pre-

03/11/2020 9 Contract No: _CL057 procedure office visit, Provider will receive $___40__ (a prorated share of the unit price) for the client’s office visit.

2. Invoice Requirements

a. Provider will request payment on a _monthly___ basis through submission of a properly completed invoice (Exhibit C, or an invoice approved by the Department) to the Department’s Contract Manager within __15___ days following the end of the _month_____ for which the payment is being requested.

b. Payments will be authorized only for service units on the invoice which are performed in accordance with Section B.1.b. and other terms and conditions of this contract. The service units for which payment is requested, must not, either by themselves or cumulatively by totaling service units on previous invoices, exceed the total number of units or dollars authorized by this contract.

D. Special Provisions

1. Contract Renewals: This contract may be renewed on a yearly basis for no more than three years beyond the initial contract or for the term of the original contract, whichever is longer, under the same terms and conditions as the original contract. Renewals will be in writing, made by mutual agreement, and will be contingent upon satisfactory fiscal and programmatic performance evaluations as determined by the Department. Renewals are subject to the availability of funds.

2. Sterilization procedures, other than those listed in the federal regulations

(Exhibit A), for individuals who have life-threatening illnesses or for whom an unintended pregnancy would place them at risk of losing their life must receive prior approval of the State Surgeon General of the Florida Department of Health on a case-by-case basis and must be paid for with non-federal funds.