1. Services. Upon request by Quest Diagnostics, Contractor will perform laboratory testing services (“Services”) at the rates agreed upon by the parties. Contractor will perform repeat testing at no charge when necessary or requested by Quest Diagnostics. For each test it performs, Contractor will deliver test result reports to Quest Diagnostics within twenty-four hours from the time Contractor receives the specimen at its testing location. The parties will measure turn around time by starting from the time Contractor receives a specimen at its testing location and ending at the time the requesting laboratory receives a detailed test result report. Contractor must meet the specified turn around time for at least 95% of the tests it performs under this Agreement. If, in any calendar month, Contractor fails to meet the specified turn around time for at least 95% of tests it performs under this Agreement, Quest Diagnostics has no obligation to pay for Services for which Contractor did not meet specified turn around times. If additional testing is required to confirm or clarify a specific test result, and Contractor cannot perform the test within the applicable turn around time, Contractor must advise Quest Diagnostics within one hour after learning that it will not meet the specified turn-around time and provide an estimated time for issuing the test result report.
2. Specimens Not Tested. A specimen is a Specimen That Cannot be Tested if it (i) does not meet the Contractor’s requirements for the Services, (ii) is not the appropriate specimen for the Services, (iii) does not meet the specimen collection requirements specified in Contractor’s directory of services, (iv) is of questionable integrity, or (v) is unable to be tested due to Contractor assay failure or Contractor technical failure. If Contractor receives a Specimen that cannot be Tested from Quest Diagnostics, Contractor must immediately contact Quest Diagnostics to enable Quest Diagnostics to provide a specimen that Contractor can test. If Specimen cannot be tested due to contractor assay failure or technical failure, Contractor will not charge for testing.
3. Remedies for Re-Work. “Re-Work” is the tasks that Quest Diagnostics must perform due to Contractor re-performing Services on a patient’s specimen, either the same or a new specimen, due to the circumstances specified in this Section 3, and related to re-reporting test results to the ordering physician. Contractor will reimburse Quest Diagnostics for Re-work Expenses if there are any errors in the services or test results.
4. Standard of Services. Contractor represents and warrants that it will perform all Services (i) in a professional, accurate, and timely manner; (ii) in accordance with applicable state and federal testing requirements for clinical reference laboratories; (iii) in-house at Contractor’s own testing locations so that Quest Diagnostics may accurately and appropriately identify the testing location for all Services. Contractor shall not refer Services to a third-party reference laboratory without Quest Diagnostics’ prior written consent. Contractor will maintain and ensure that, during the Term, it and its employees have all Required Approvals. Required Approvals are the necessary licenses, permits, accreditation, and certifications, including approvals for specialties or subspecialties required under applicable laws, including Contractor’s applicable accreditation agency or agencies, for Contractor and its clinical laboratories to perform the Services on the specimens referred to Contractor by Quest Diagnostics under this Agreement. Contractor warrants that it currently maintains all Required Approvals. Before performing any Services, Contractor shall provide to Quest Diagnostics a copy of all Required Approvals. Contractor shall provide to Quest Diagnostics a copy of any renewal of the Required Approvals within thirty days after the renewal date. If Contractor loses any Required Approval or a licensing authority denies Contractor any Required Approval, Contractor must notify Quest Diagnostics immediately. Quest Diagnostics will stop referring specimens to Contractor in the states affected until Contractor demonstrates that it has the Required Approval. Quest Diagnostics may consider Contractors recurring loss of Required Approvals as a material breach, which authorizes Quest Diagnostics to terminate this Agreement. Contractor must provide a copy of any new Required Approvals that it obtains during the Contract Period to Quest Diagnostics within thirty days after receiving them. If Contractor performs Services which require approval from New York State (e.g., laboratory-developed tests, modified FDA cleared- or approved-assays, or tests performed using an RUO or IUO kit), Contractor represents and warrants that Contractor has and maintains those approvals. If Contractor does not have the required individual test approval, the Contractor will notify Quest Diagnostics and Quest Diagnostics will apply, on a patient-by patient-basis, for a “Non-Permitted Laboratory” approval from New York State before the Contractor may perform the affected test.
5. Changes. Contractor shall send a Change Notice to Quest Diagnostics at least ninety days’ before making any change to testing methods, sample requirements, or reporting elements for the Testing Services. In the event that the Contractor discontinues or in any other manner makes a contracted Service or test unavailable for purchase by Quest Diagnostics at any time during the Term of this Agreement, and as a result of any such actions Contractor replaces such Service or test (the “Replaced Service”) with a similar service (the “Replacement Service”) intended to be used for substantially the same or similar purpose as the Replaced Service, then the price to be charged by Contractor and paid by Quest Diagnostics for the Replacement Service will be the same as the price of the Replaced Service as set forth in this Agreement.
6. Utilization Reports. By the fifteenth day of each month, Contractor shall furnish monthly utilization reports to the Sourcing Manager, the National Director, Referral Testing, and any other personnel designated by Quest Diagnostics from time to time.
7. Term and Termination. The term of this agreement start on the Effective Date and continue until terminated as provided herein (“Term”). Either party may terminate this Agreement at any time, with or without cause, upon providing 30 days’ prior written notice to the other party. Quest Diagnostics may immediately terminate this Agreement if any agency takes action against Contractor to revoke, suspend, or terminate its federal or state licenses to operate a clinical laboratory, or to revoke, suspend or terminate its participation in Medicaid, Medicare, or other federally funded programs. Either party may terminate this Agreement immediately on written notice if the other party has committed a material breach of this Agreement and has not cured the breach within fifteen days after written notice of the breach by the non-breaching party. A material breach includes failure to comply with Applicable Laws.
8. Pricing, Invoicing, and Payment. Contractor will invoice Quest Diagnostics for Services performed at the prices agreed upon by the parties. Quest Diagnostics will pay Contractor’s invoices net 60 days end of month. Contractor will give Quest Diagnostics a prompt payment discount of 2% if Quest Diagnostics pays Contractor’s invoice within thirty days from the invoice date. “Net 60 days end of month” as used herein means that the applicable monthly invoice must be paid by the end of the calendar month that is 60 days from the date of the applicable monthly invoice. For example, a monthly invoice dated January 1 would be payable by March 31; a monthly invoice dated January 25 would also be payable by March 31. Quest Diagnostics will pay Contractor by [use of a ghost card, ACH transfer, electronic funds transfer, check ]. All invoices must be in sufficient detail, as reasonably requested by Quest Diagnostics, to identify the billable tests and the price per test. Quest Diagnostics will not pay for Services that produce invalid test results, unless Quest Diagnostics caused the invalid result. Contractor’s failure to submit invoices in the time required or to provide sufficient documentation as requested is a basis for Quest Diagnostics to deny a claim for payment. On a monthly basis, Contractor will send invoices electronically through secured email to designated contacts at each respective Quest Diagnostics ordering laboratory. If new Services are added to the book of business between Quest Diagnostics and the Contractor at any time during the Term of this Agreement, and such new Services are not subject to the last sentence of Section 5, “Changes,” of this Agreement, then the prices to be paid by Quest Diagnostics for such new Services, from the time that they are added until the expiration or termination of this Agreement, will be discounted by a percentage not less than the average discount percentage between Contractor’s published list prices and the prices paid by Quest Diagnostics for similar Services as set forth in this Agreement or determined based on Quest Diagnostics’ purchases of all other Services in the twelve (12) months preceding the addition of the new Services.
9. Indemnification. Contractor must indemnify, defend and hold Quest Diagnostics, its subsidiaries and affiliates and their employees, agents, servants and representatives, harmless from any claim, liability, loss, suit, damage, cost or expense, including reasonable attorneys’ fees and expenses (“Claims”) that (i) is based on any allegation, which if true would constitute a breach of this Agreement by Contractor; (ii) alleges personal injury, death, or property damage arising out of Contractor’s furnishing of the Services or arising out of the negligence or willful misconduct of Contractor, its employees, subcontractors, directors, or officers related to this Agreement; (iii) is based on any third party Claims brought against Quest Diagnostics arising out of Contractor’s failure to inform Quest Diagnostics of a test methodology change; or (iv) is based on any third parties Claims for injunctive relief, compensatory damages, treble damages, exemplary damages, and/or attorneys’ fees for patent infringement, misappropriation of trade secrets or intellectual property, or any similar claims.
10. Insurance. Contractor must maintain professional liability and general liability insurance during the Term and for twelve months afterwards in amounts adequate to cover its obligations under this Agreement. This coverage must be, at a minimum, $2,000,000 per claim and $5,000,000 annual aggregate. Upon request, Contractor will furnish a current and valid certificate of insurance, or proof of adequate self-insurance, evidencing its general liability and professional liability insurance coverage. If the insurance is of the “claims made” basis, Contractor must continue the insurance for so long as claims may be made legally with respect to occurrences during the Term.
11. Excluded Provider. Each party represents and warrants that it (i) has not been convicted of a crime related to health care, or (ii) is not currently listed by a federal agency as debarred, excluded or otherwise ineligible to participate in federally funded programs. If either of the above representations or warranties changes, the affected party must notify the other in writing within five days after the party receives notice that it is an excluded provider. The party receiving this notice has the right to terminate this Agreement at any time after receiving the notice. For purposes of this Section, “Quest Diagnostics” and “Contractor” include the entity entering into this Agreement and the entity’s parent, principals, shareholders, directors, and officers (including subcontractors or employees).
12. Medicare Advantage Beneficiaries. If any patients served under this Agreement include Medicare Advantage beneficiaries under contracted Medicare Advantage Programs, the provisions of Schedule 1 apply.
13. HIPAA. “HIPAA” means the Health Insurance Portability and Accountability Act of 1996. “Privacy Regulations” means all regulations issued pursuant to HIPAA and applicable (respectively) to the privacy of patients’ individually identifiable health information, as amended from time to time. “Security Regulations” means all regulations issued pursuant to HIPAA and applicable (respectively) to the security of patients’ individually identifiable health information, as amended from time to time. “Protected Health Information” has the meaning set forth in the Privacy Regulations. All other terms used, but not otherwise defined in this Subsection, have the same meaning as those terms have in the Code of Federal Regulations applicable to HIPAA or any successor statute. Each party represents and warrants, with respect to all Protected Health Information, that it is a covered entity (and not a business associate of the other party) under the Privacy Regulations. Each further represents and warrants that it will protect the privacy, integrity, security, confidentiality, and availability of Protected Health Information disclosed to, used by, or exchanged by the Parties. Each Party will implement and maintain privacy and security policies, procedures, and practices, and administrative, physical, and technological safeguards and security mechanisms that reasonably and adequately protect the confidentiality, integrity, and availability of the Protected Health Information created, received, maintained, or transmitted under this Agreement as required by the Privacy Regulations and the Security Regulations. If HIPAA or the Privacy Regulations or Security Regulations require any addition to or modification of this Agreement, the parties must use commercially reasonable efforts to agree upon the additions or modifications in a timely manner.
14. Federal Program Access To Records.
14.1 Access. If a Federal Program pays for any Testing Services, Contractor will, upon written request, make this Agreement and all Medical Records available to the Secretary of the Department of Health and Human Services (HHS), the Comptroller General, or their duly authorized representatives. This provision applies if the amount paid under this Agreement is $10,000 or more over a twelve-month period. The availability of Contractor’s Medical Records must at all times be subject to the criteria and procedures for seeking or obtaining access as may be promulgated by the Secretary of HHS in regulations, and other Applicable Laws. Contractor’s disclosure under this provision is not as a waiver of any legal rights to which Quest Diagnostics or Contractor may be entitled under statute or regulation.
14.2 Audit. Contractor also acknowledges that HHS, the Comptroller General, or their designees have the right to audit, evaluate, or inspect Contractor’s (or its subcontractors’ or transferees’) Medical Records and other Records, related to Quest Diagnostics’ Medicare Contracts with Health Plans. This right extends for the period provided in 42 CFR § 422.502(e) (4) or other Applicable Law. Contractor agrees to make available its premises, physical facilities and equipment, Records relating to its Medicare and any additional relevant information for six years or as required by Applicable Law.
15. Federal Government Contract Flowdown Terms. To the extent Provider will provide services to Quest Diagnostics in direct support of a federal government contract, the following Federal Acquisition Regulations may apply to Provider: (i) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)); (ii) 52.219-8, Utilization of Small Business Concerns (Jul 2013) (15 U.S.C. 637(d)(2); (iii) 52.222-17, Nondisplacement of Qualified Workers (JAN 2013) (E.O. 13495); (iv) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246); (v) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496); (vi) 52.222-41, Service Contract Act of 1965 (Nov 2007) (41 U.S.C. 351, et seq.); and, (vii) 52.222-50, Combating Trafficking in Persons (Feb 2009) (22 U.S.C. 7104(g)). In addition, the following government regulations may apply: FAR 52.222-35, Equal Opportunity for Veterans (Sep 2010) (38 U.S.C. 4212), also found at 41 CFR 60-300.5(a), and FAR 52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793), also found at 41 CFR 60-741.5(a), which regulations prohibit discrimination against qualified protected veterans and qualified individuals on the basis of disability, and requires affirmative action by covered prime contractors and subcontractors to employ, and advance in employment, qualified protected veterans and individuals with disabilities. Contractor’s work under this Agreement may be subject to the requirements of the Service Contract Labor Standards, also known as the Service Contract Act (the “Act” or “SCA”). The Act outlines the minimum monetary wages and fringe benefits that must be paid to service employees according to the applicable United States Department of Labor (“DoL”) Wage Determinations (“WDs”). Quest Diagnostics has incorporated by reference the WDs for all geographic areas currently available on the DoL website www.wdol.gov. Revised WDs (including any separately numbered WDs covering all or part of a geographic area covered by an existing WD) will become applicable to this Agreement upon publication by DoL to www.wdol.gov. Contractor understands and acknowledges that there are significant financial penalties imposed by DoL for any non-adherence to the SCA. Contractor agrees that it is its sole responsibility for any failure to comply with these requirements. Contractor agrees to make any payments required, and to hold harmless and indemnify Quest Diagnostics for any failure on the part of Contractor to comply with the SCA. The failure to incorporate any WD or to incorporate any clauses related to compliance with the SCA shall not excuse Contractor from its obligations under the SCA or operate as a defense to Contractor’s obligations under this Agreement if Contractor fails to comply with the SCA’s requirements. In the event that there are changes or additions to the preceding regulations based on the performance of federal government contracts, Quest Diagnostics may unilaterally amend this Agreement for purposes of complying with the changes or additions by sending a notice of amendment to Contractor.
16. Confidentiality. Each party to this Agreement shall keep in confidence all confidential information of the other party including, but not limited to, information relating to the other party’s finances, methods of operation and competition, pricing, marketing plans and strategies, equipment and operational requirements and information concerning personnel, patients and suppliers, unless such information (i) is in the possession of the party receiving it without obligation of confidence, (ii) is developed by the party receiving it independently from its receipt of the information, (iii) is or becomes generally available to the public other than as a result of a disclosure by that party, or (iv) is required to be disclosed by law or by a judicial, administrative or regulatory authority. Each party will return all written proprietary, confidential information of the other which is still in possession of the party to whom it was furnished on the date of the termination of this Agreement. Each party’s confidentiality obligations hereunder shall remain in full force and effect for five (5) years from the Effective Date of this Agreement.
17. Notices. Except as otherwise expressly provided in this Agreement, any notices or communications required or contemplated by this Agreement must be in writing and sent, properly addressed to the other party at its address listed below that party’s signature line or to any other name or address that a party may specify to the other party in writing.
18. Governing Law and Venue. The Law of the State of New Jersey, without regard to its conflict of law principles, shall govern any dispute with respect to this Agreement. The parties agree to submit to the exclusive jurisdiction of the federal and state courts located in New Jersey for the resolution of any disputes. THE PARTIES HEREBY IRREVOCABLY WAIVE, TO THE EXTENT PERMITTED BY LAW, ALL RIGHTS TO TRIAL BY JURY IN ANY ACTION, PROCEEDING, OR COUNTERCLAIM RELATING TO OR ARISING FROM THIS AGREEMENT. Each party represents that it has reviewed this waiver and knowingly and voluntarily waives its jury trial rights following consultation with legal counsel. If there is litigation, either party may file a copy of this Agreement as a written consent to a trial by the court. EACH PARTY SHALL BEAR ITS OWN COSTS AND EXPENSES INCLUDING REASONABLE ATTORNEYS’ FEE.
19. Relationship of the Parties. Nothing contained in this Agreement creates a joint venture, partnership, or employment relationship between the parties. Neither party is the agent of the other. Neither party has any authority to bind the other.
20. Assignment. Neither party may assign its rights or delegate its duties or obligation under this Agreement to a third party without the prior written consent of the other party. However, either party may assign this Agreement (or any of its rights or interest) to a successor entity to which the assigning party transfers or assigns all or substantially all of its assets. The assigning party will provide written notice to the other party of the assignment and will remain liable for the assignee’s performance of its duties or obligations under this Agreement.
21. Entire Agreement. This Agreement contains the entire understanding between Quest Diagnostics and Contractor. It supersedes all prior agreements, understandings, and arrangements between them relating to the subject matter hereof.
22. Non-Exclusive Arrangement. This is a non-exclusive arrangement and this Agreement places no restrictions on Quest Diagnostics’ ability to refer specimens to other laboratories for testing. Quest Diagnostics does not guarantee that it will refer any minimum volume of specimens to Contractor.
Medicare Advantage Contractor Compliance Attachment
In addition to the terms and conditions of the Agreement, Contractor agrees to comply with the terms and conditions specified by CMS as set forth below. To the extent of a conflict between the terms of the Agreement and this Attachment, the terms of the Attachment will control with respect to MA Enrollees.
Agreement (including all in-force amendments and addenda) means the agreement between Quest Diagnostics (the “First Tier Entity”) and Contractor (the “Downstream Contractor”) that specifies the contractual relationship between for the provision of services to Enrollees.
Centers for Medicare and Medicaid Services (“CMS”) mean the agency within the Department of Health and Human Services that administers the Medicare program.
Completion of Audit means completion of audit by the Department of Health and Human Services, the General Accounting Office, or their designees of a Medicare Advantage Organization, Medicare Advantage Organization contractor or related entity.
Downstream Contractor means an entity or individual that is contracted by a First Tier Entity to provide services to MA Enrollees. A Downstream Contractor may be, but is not limited to, physicians, ancillary providers, and other health care providers.
First Tier Entity means the entity that contract with a Medicare Advantage Organization, (MAO) to provide services to MA Enrollees. A First Tier Entity may be, but is not limited to, medical groups, clinical laboratories, and hospitals.
Medicare Advantage Organization (“MAO”) means a health plan that has entered into a contract with CMS to provide services to Medicare beneficiaries under the Medicare Advantage program.
Medicare Advantage (“MA”) is an alternative to the traditional Medicare program in which private plans run by health insurance companies provide health care benefits that eligible beneficiaries would otherwise receive directly from the Medicare program.
Member means an individual who has enrolled in or elected coverage through a Medicare Advantage Organization. A Member is also known as an MA Enrollee.
Downstream Contractor agrees to comply with all applicable Medicare laws, regulations, and CMS guidance. [42 C.F.R § 422.504(i)(4)(v).]
Downstream Contractor agrees to retain and to grant the Department of Health and Human Services (HHS), the Comptroller General or their designees the right to inspect, evaluate, and audit any pertinent information, including books, contracts, medical records, patient care documentation, and records of subcontractors or related entities for a period of (10) years from the end of the final date of the contract period or completion of audit, whichever is later, for Members enrolled in a Medicare Advantage Organization. [42 C.F.R § 422.504(i)(2).]
Downstream Contractor agrees to hold harmless and protect Members from incurring financial liabilities that are the legal obligation of the MAO, First Tier Entity, or Downstream Contractor. In no event, including but not limited to, nonpayment or breach of an agreement by the MAO, First Tier Entity, Downstream Contractor, or other intermediary, or the insolvency of the MAO, First Tier Entity, Downstream Contractor, or other intermediary, shall Downstream Contractor bill, charge, collect a deposit from or receive other compensation or remuneration from a Member. Downstream Contractor shall not take any recourse against the Member, or a person acting on behalf of the Member, for services provided. [42 C.F.R § 422.504(g) and (i)(3)(i)].
Downstream Contractor agrees that its performance or other activity are consistent and comply with the First Tier Entity’s contractual obligations with the MAO, which includes the First Tier Entity’s agreement that its performance or other activities are consistent and comply with the MAO’s contractual obligations with CMS. [42 C.F.R 422.504(i)(3)(iii)].
Downstream Contractor agrees that that all of its employees who provide administrative services or health care services for MAO pursuant to the Agreement participate in Medicare FWA training and Medicare General Compliance training within ninety (90) days of hire and annually thereafter. Required FWA and General Compliance training is developed and provided by CMS and is available through the CMS Medicare Learning Network (MLN) at http://www.cms.gov/MLNProducts. Downstream Contractor is deemed to have met this FWA and General Compliance training requirement if it is either (i) enrolled in Medicare Part A or B, or (ii) accredited as a supplier of DMEPOS. Downstream Contractor must maintain documentation sufficient to demonstrate to First Tier Entity that Downstream Contractor fulfilled the FWA and General Compliance training requirement. [MMC Manual, Chapter 21, § 50.3.2; 42 C.F.R. § 422.503(b)(4)(vi)(C).]
Downstream Contractor agrees to report compliance or FWA concerns to CMS or First Tier Entity. Reporting should occur within 5 days of discovery; if there is an immediate impact to beneficiary access to care and/or a financial strain, please report immediately but at least within 24 hours. [42 C.F.R. § 422.504(b)(4)(vi)(D).]
Downstream Entity agrees to establish and publish its own disciplinary standards, which include its expectation that employees report compliance issues and unethical or illegal behavior. Downstream Contractor’s disciplinary standards must state that any violation of these standards will result in appropriate disciplinary action, up to and including termination of employment. Violation of this provision may result in termination of the Agreement. [42 C.F.R. §§ 422.503(b)(4)(vi)(E) and 422.504(b)(4)(vi)(E).]
Downstream Contractor certifies that neither it nor any of its employees or governing body members are on: (a) the List of Excluded Individuals and Entities (“LEIE”) from the HHS Office of Inspector General (“OIG”); and (b) the General Services Administration (“GSA”) Debarment List. If an employee or governing body member is on either list, Downstream Contractor will immediately remove that person from any work related directly or indirectly to any Federal healthcare program. Downstream Contractor agrees to check both lists prior to hire and on a monthly basis to ensure that none of its employees have become excluded from participation in Federal programs. The term “employees” includes temporary employees, volunteers, and consultants. If applicable, Downstream Contractor will establish a process to identify and prevent payment for claims at point-of-sale for any drugs or services prescribed, dispensed or delivered by excluded providers. [42 C.F.R. §§ 422.503(b)(4)(vi)(F), 422.752(a)(8); and 42 C.F.R. § 1001.1901.]
MAO and Quest may monitor and audit Downstream Contractor’s performance under the Agreement on an ongoing basis. Quest has the option to terminate the Agreement with Downstream Contractor if MAO or Quest determines that Downstream Contractor’s has (a) not performed satisfactorily under the terms of the Agreement or Compliance Addendum, (b) failed to maintain compliance, or (c) engaged in FWA. [42 C.F.R § 422.503(b)(4)(vi)(F).]
Downstream Contractor shall incorporate the terms of this Compliance Addendum into any and all subcontracts entered into delegating any of its obligations under the Agreement or Compliance Addendum. [42 C.F.R § 422.504 (i)(4)(v).]
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