Written Standards Sample Clauses
The Written Standards clause establishes that certain requirements, procedures, or expectations must be documented in writing to be valid and enforceable. In practice, this means that any standards governing performance, quality, or conduct must be clearly set out in written form, such as manuals, policies, or formal communications, rather than relying on informal or verbal agreements. This clause ensures clarity and consistency by providing a tangible reference point for all parties, reducing misunderstandings and disputes over what standards apply.
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Written Standards. Within 90 days after the Effective Date, Renew shall develop and implement written policies and procedures (Policies and Procedures) that address the following: (1) the operation of Renew’s compliance program, including the compliance program requirements outlined in this CIA; (2) Renew’s compliance with Federal health care program requirements, including but not limited to compliance with the Anti-Kickback Statute and the ▇▇▇▇▇ Law, and the regulations and other guidance documents related to these statutes; (3) a written review and approval process for Arrangements, the purpose of which is to ensure that all Arrangements do not violate the Anti-Kickback Statute and the ▇▇▇▇▇ Law; and (4) the identification, quantification, and repayment of Overpayments. Renew shall enforce its Policies and Procedures and make compliance with its Policies and Procedures an element of evaluating the performance of all Covered Persons. The Policies and Procedures shall be made available to all Covered Persons. The Compliance Committee shall review the Policies and Procedures at least annually and update the Policies and Procedures as necessary. Any new or revised Policies and Procedures shall be made available to all Covered Persons. All Policies and Procedures shall be made available to OIG upon request.
Written Standards. Within 90 days after the Effective Date, Post Acute Medical shall develop and implement written policies and procedures regarding the operation of its compliance program, including the compliance program requirements outlined in this CIA and Post Acute Medical’s compliance with Federal health care program requirements (Policies and Procedures). The Policies and Procedures also shall address:
Written Standards. Contractor shall maintain written standards of conduct governing the performance of its employees engaged in the award and administration of contracts or subcontracts. No employee, officer, or agent of the Contractor shall participate in the selection, award, or administration of a subcontract supported by federal funds if a real or apparent conflict of interest would be involved. Such a conflict would arise when the employee, officer, or agent, any member of his or her immediate family, his or her partner, or an organization that employs or is about to employ any of the parties indicated herein, has a financial or other interest in the firm selected for an award. The officers, employees, and agents of the Contractor shall neither solicit nor accept gratuities, favors, or anything of monetary value from subcontractors or parties to sub agreements. The standards of conduct shall provide for disciplinary actions to be applied for violations of such standards by officers, employees, or agents of the recipients.
Written Standards. Within 120 days after the Effective Date, CHN shall develop and implement written policies and procedures (Policies and Procedures) that address the following: (1) the operation of CHN’s compliance program, including the compliance program requirements outlined in this CIA; (2) CHN’s compliance with Federal health care program requirements, including but not limited to compliance with the Anti-Kickback Statute and the ▇▇▇▇▇ Law, and the regulations and other guidance documents related to these statutes, and business or financial arrangements or contracts that generate unlawful Federal health care program business in violation of the Anti-Kickback Statute or the ▇▇▇▇▇ Law; (3) the requirements set forth in Section III.D below; and (4) the identification, quantification, and repayment of Overpayments. CHN shall enforce its Policies and Procedures and make compliance with its Policies and Procedures an element of evaluating the performance of all Covered Persons. The Policies and Procedures shall be made available to all Covered Persons. The Compliance Committee shall review the Policies and Procedures at least annually and update the Policies and Procedures as necessary. Any revised or new Policies and Procedures shall be made available to all Covered Persons. All Policies and Procedures shall be made available to OIG upon request.
Written Standards. Within 90 days after the Effective Date, Progenity shall develop and implement written policies and procedures regarding the operation of its compliance program, including the compliance program requirements outlined in this CIA and Progenity’s compliance with Federal health care program requirements (Policies and Procedures). The Policies and Procedures also shall address:
a. 42 U.S.C. § 1320a-7b(b) (Anti-Kickback Statute) and the ▇▇▇▇▇ Law, and the regulations and other guidance documents related to these statutes, and business or financial arrangements or contracts that generate unlawful Federal health care program business in violation of the Anti-Kickback Statute or the ▇▇▇▇▇ Law; and
b. the requirements set forth in Section III.D (Compliance with the Anti-Kickback Statute and ▇▇▇▇▇ Law). The Policies and Procedures shall be made available to all Covered Persons. Throughout the term of this CIA, Progenity shall enforce its Policies and Procedures and shall make compliance with its Policies and Procedures an element of evaluating the performance of all employees. At least annually (and more frequently, if appropriate), Progenity shall assess and update, as necessary, the Policies and Procedures. Any revised or new Policies and Procedures shall be made available to all Covered Persons. All Policies and Procedures shall be made available to OIG upon request.
Written Standards. Within 120 days after the Effective Date, Sanofi shall develop and implement written policies and procedures regarding the operation of its compliance program, including the compliance program requirements outlined in this CIA and Sanofi’s compliance with Federal health care program requirements (Policies and Procedures). Throughout the term of this CIA, Sanofi shall enforce its Policies and Procedures and shall make compliance with its Policies and Procedures an element in evaluating the performance of all employees. The Policies and Procedures shall be made available to all Covered Persons. At a minimum, the Policies and Procedures shall address the following:
a. appropriate ways to conduct Contribution and Assistance Related Functions in compliance with all applicable Federal health care program requirements, including but not limited to, the Federal Anti-Kickback Statute (codified at 42 U.S.C. § 1320a-7b(b)) and the False Claims Act (codified at 31 U.S.C. §§ 3729-3733);
b. arrangements and interactions with (including donations to and sponsorship of) Independent Charity PAPs. These Policies and Procedures shall be designed to ensure that Sanofi’s arrangements and interactions comply with all applicable Federal health care program requirements. The Policies and Procedures shall also be designed to ensure that Sanofi’s arrangements and interactions (including donations and sponsorship) comply with all guidance issued by OIG relating to the support and funding of patient assistance programs, including but not limited to, the OIG’s Special Advisory Bulletin on Patient Assistance Programs for Medicare Part D Enrollees, 70 Fed. Reg. 70623 (Nov. 22, 2005) and OIG’s Supplemental Special Advisory Bulletin: Independent Charity Patient Assistance Programs, 79 Fed. Reg. 31120 (May 30, 2014);
c. the operation of, or participation in, any Sanofi PAP. These Policies and Procedures shall be designed to ensure that Sanofi’s operation of or in participation in such programs complies with all applicable Federal health care program requirements. The Policies and Procedures shall also be designed to ensure that Sanofi’s operation of or participation in any such Sanofi PAP complies with all guidance issued by OIG relating to assistance provided to patients by pharmaceutical manufacturers to reduce or eliminate the cost of copayments for drugs, including but not limited to, the OIG’s Special Advisory Bulletin on Pharmaceutical Manufacturer Copayment Coupons (Sept. 2014);
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Written Standards. Within 90 days after the Effective Date, Genova shall develop and implement written policies and procedures regarding the operation of its compliance program, including the compliance program requirements outlined in this CIA and Genova’s compliance with Federal health care program requirements (Policies and Procedures). Throughout the term of this CIA, Genova shall enforce its Policies and Procedures and shall make compliance with its Policies and Procedures an element of evaluating the performance of all employees. The Policies and Procedures shall be made available to all Covered Persons. The Policies and Procedures shall, at a minimum, address:
Written Standards. Within 90 days after the Effective Date, the U.S. Healthcare Parties shall develop and implement written policies and procedures regarding the operation of their compliance program, including the compliance program requirements outlined in this CIA and compliance with Federal health care program requirements (Policies and Procedures). Throughout the term of this CIA, the U.S. Healthcare Parties shall enforce their Policies and Procedures and shall make compliance with their Policies and Procedures an element of evaluating the performance of all employees. The Policies and Procedures shall be made available to all Covered Persons. At least annually (and more frequently, if appropriate), the U.S. Healthcare Parties shall assess and update, as necessary, the Policies and Procedures. Any new or revised Policies and Procedures shall be made available to all Covered Persons. All Policies and Procedures shall be made available to OIG upon request.
Written Standards. Within 90 days after the Effective Date, UHS shall develop and implement written Policies and Procedures regarding the operation of UHS’s compliance program, including the compliance program requirements outlined in this CIA, compliance with Federal health care program requirements, and professionally recognized standards of care (Policies and Procedures). Throughout the term of this CIA, UHS shall enforce its Policies and Procedures and shall make compliance with its Policies and Procedures an element of evaluating the performance of all employees. The Policies and Procedures shall address:
1. Medical necessity of patient admissions;
2. Appropriate use of involuntary commitment;
3. Medical necessity of continuing stays;
4. The requirement to provide active and individualized treatment;
5. Physician participation in and supervision of care;
6. The proper use and monitoring of physical and chemical restraints and seclusion;
7. Interdisciplinary, patient-centered, care planning; and
8. Appropriate staffing levels, qualification, licensure, supervision, and training to meet patients’ needs and to comply with Federal and State requirements. The Policies and Procedures shall be made available to all Covered Persons. At least annually (and more frequently, if appropriate), UHS shall assess and update, as necessary, the Policies and Procedures. Any new or revised Policies and Procedures shall be made available to all Covered Persons. All Policies and Procedures shall be made available to OIG upon request.
Written Standards. Within 120 days after the Effective Date, Lincare shall develop and implement written policies and procedures (Policies and Procedures) that address the following: (1) the operation of Lincare’s compliance program, including the compliance program requirements outlined in this CIA; (2) Lincare’s compliance with Federal health care program requirements, including but not limited to compliance with the Anti-Kickback Statute and the ▇▇▇▇▇ Law, and the regulations and other guidance documents related to these statutes;