clonoSEQ Standard Terms
Terms and Conditions
- ADAPTIVE SERVICES.
- Services Generally.
Adaptive will provide reference laboratory services as described in the cover sheet attached, and subject to, these terms and conditions (the “Services”). Adaptive will provide the Services to Facility patients as ordered by Facility-affiliated health care professionals (“Ordering Person”).
- Test Results Reporting; Secure Communications.
- Services Generally.
- General Rule.
Facility shall elect either “Bill My Facility” or “Adaptive Third-Party Bill” on the Account Setup Form, with the details of such selections further set forth below. This selection on the Account Setup Form will apply unless one of the exceptions in Section 2(b) or 2(c) overrides such selection.
- Bill My Facility.
If Bill My Facility is selected, Facility will be solely responsible for submitting claims for reimbursement to patients and payers for all Services provided by Adaptive to Facility under this Agreement. It is Facility’s sole responsibility to make all ICD-10, CPT, and/or HCPCS coding decisions and all other decisions related to billing payers or patients for the Services. Facility acknowledges and agrees that Adaptive will not be responsible for any denied claims or overpayment demands made by any payer or insurer to Facility related to the Services hereunder. Facility will pay Adaptive in accordance with Section 2(d).
- Adaptive Third-Party Bill.
If Adaptive Third-Party Bill is selected, Adaptive will be solely responsible for submitting claims for reimbursement to patients and payers for all Services provided by Adaptive to Facility under this Agreement. Facility acknowledges and agrees that it will be prohibited from submitting claims for reimbursement to patients and payers if Adaptive Third-Party Bill is selected. Facility agrees to provide Adaptive with all information necessary to handle billing matters, as specified in Section 2(e).
- Bill My Facility.
- Medicare Patient Exceptions.
With respect to Services provided to Facility patients who are covered by Medicare, regardless of the election made pursuant to Section 2(a), Adaptive will follow Medicare billing guidelines for determining whether Bill My Facility or Adaptive Third-Party Bill is required for a given claim.
- Non-Medicare Exceptions.
- Non-Medicare Payer Requires Adaptive Third-Party Bill.
If a non-Medicare payer (including, but not limited to, Medicaid, Medicare Advantage, Managed Medicaid, or private third-party payer) requires Adaptive to bill directly for certain Services provided by Adaptive to Facility under this Agreement, then Adaptive will be solely responsible for submitting claims for reimbursement to the commercial payer for all such Services provided by Adaptive to Facility under this Agreement, regardless of the election made pursuant to Section 2(a).
- Non-Medicare Payer Requires Bill My Facility.
If a non-Medicare payer (including, but not limited to, Medicaid, Medicare Advantage, Managed Medicaid, or private third-party payer) requires Facility to bill directly for certain Services provided by Adaptive to Facility under this Agreement, then Facility will be solely responsible for submitting claims for reimbursement to the commercial payer for all such services provided by Adaptive to Facility under this Agreement, regardless of the election made pursuant to Section 2(a).
- Non-Medicare Payer Requires Adaptive Third-Party Bill.
- Payment Terms for Bill My Facility.
If Bill My Facility is selected, subject to Sections 2(b) and 2(c), Facility will pay Adaptive in accordance with the fee schedule set forth in the Account Setup Form (or if blank, as set forth in the then-current OCS).
- Pricing Changes.
Pricing may be revised by Adaptive upon 30 days’ advance written notice to Facility.
Adaptive will invoice Facility for Services in accordance with Adaptive’s customary billing practices. Adaptive will maintain administrative records relating to fees charged for Services in accordance with Applicable Laws and make them accessible to Facility on 2 weeks’ notice during the Term.
Facility will pay invoiced fees due hereunder within 30 days after receipt of the invoice therefor without any deduction or setoff; provided, however, that Facility may contest or deny a claim, or portion thereof, by notifying Adaptive, in writing, that the claim is contested or denied, within 30 days of receipt of the relevant invoice, and Facility may withhold the portion of any invoice timely contested or denied by Facility in good faith until the dispute is resolved. Any amounts not disputed in good faith that remain unpaid within 30 days will accrue interest at 1.5% per month, not to exceed the maximum permitted by Applicable Law. Facility will pay collection expenses on overdue undisputed amounts. Adaptive reserves the right to cease performing services until outstanding past due amounts have been fully paid.
To the extent the fees include any discounts or rebates, each Party agrees to use its best efforts to comply with all applicable provisions of 42 C.F.R. § 1001.952(h) (the “Discount Regulations”). Specifically, Adaptive agrees to accurately report the discount on any invoice or statement to Facility and to provide upon request all information needed by Facility to comply with the reporting obligations of the Discount Regulations. Facility agrees to fully and accurately report the discount in its cost reports for the fiscal year in which the discount was received and to provide to the Secretary of Health and Human Services or applicable State agency all information provided to Facility by Adaptive.
- Payment Terms for Adaptive
Third-Party Bill. If Adaptive Third-Party Bill is selected or required, then the following terms will apply:
- Adaptive shall be solely responsible for billing patients and commercial insurers. Facility agrees it shall not submit any claims, collect any monies from patients, or otherwise bill or receive payment for Services provided by Adaptive when Adaptive Third-Party Bill is elected on the Account Setup Form, unless Bill My Facility is required per Sections 2(b) and 2(c).
- Facility will supply Adaptive with a copy of an insurance card and all current, complete, and necessary billing information for each specimen Facility submits to Adaptive that is required for Adaptive to bill and collect from the appropriate payer(s), including payer name, payer identification number(s), patient name, Facility medical record number, date of service, ordering practitioner name, ordering practitioner NPI, ICD-10 code(s), and units/quantity. Adaptive may update the list of required information from time to time and will timely communicate any changes in such required information to Facility. Adaptive may bill Facility for any such tests for which Facility fails to timely submit current and accurate billing information pursuant to this paragraph.
- Canceled Test Orders.
Facility may cancel an order for a test by providing notice of cancellation. If received by Adaptive prior to the order being activated, the test will not be billed. If received after order activation, the test may be billed.
- Failure Report – No Result Available.
If Adaptive determines that it is unable to analyze a specimen, either as a result of the sample failing Adaptive’s quality control criteria or as a result of a problem processing the specimen, Adaptive will issue a failure report and will not charge Facility with respect thereto. A test result that indicates that no dominant clone was detected does not constitute a failed test.
- Demarcation of Specimens.
Facility will cause its Facility Personnel to mark all test requisition forms (each a “TRF”) consistently with the billing arrangements set forth in this Agreement, and Adaptive shall be entitled to rely on the accuracy of such information for billing and regulatory purposes. Facility agrees to indicate for each specimen on the TRF whether the specimen is required to be a Bill My Facility or Adaptive Third-Party Bill specimen, notwithstanding Facility’s election per Section 2(a).
- Claims Appeals Information.
Facility will promptly (but in any event within 10 business days) provide where reasonably requested by Adaptive, patient medical records to support claims appeals with third-party payers.
- Payer Pre-Approval (If Required).
If Facility’s or the patient’s arrangement with an insurer or other third-party payer requires Facility be responsible for obtaining prior authorization for the Services, then Adaptive will not be allowed to request prior authorization, and, therefore, Facility must obtain the prior authorization and provide the relevant prior-authorization number on the TRF.
- Advanced Beneficiary Notice (ABN) for Medicare Patients (If Required).
Medicare mandates that if a test provided to a beneficiary is deemed medically unnecessary pursuant to a National Coverage Determination (“NCD”), Local Coverage Determination (“LCD”), or coverage article, Adaptive may only bill the patient if an Advance Beneficiary Notice (“ABN”) has been properly completed, issued, and signed by the patient before the time that the specimen is collected. Accordingly, when there is reason to expect that a test(s) may be noncovered by Medicare, Facility must ask the patient to sign a completed ABN before the specimen is collected and submit that signed ABN to Adaptive.
- Changes in Billing Laws.
In the event of any change in the laws and regulations affecting the billing arrangements set forth above, the Parties agree to negotiate in good faith to update such billing arrangements accordingly.
- General Rule.
- COMPLIANCE AND LICENSURE.
Each Party will comply with all laws, rules, and regulations applicable to it in connection with the activities of such Party contemplated by this Agreement, as they may be amended from time to time (“Applicable Laws”). Applicable Laws include, but are not limited to, the federal Physician Self-Referral Law, 42 U.S.C. § 1395nn, and the regulations promulgated thereunder and similar State physician self-referral laws and regulations, the federal Clinical Laboratory Improvement Amendments of 1988 and similar State laws and regulations governing licensing and supervision of laboratory personnel, the federal Anti-Kickback Statute 42 U.S.C. §1320a-7b(b) and regulations promulgated thereunder and similar State Anti-Kickback laws and regulations.
- Adaptive Personnel and Facilities.
Adaptive will employ duly licensed, trained, and qualified personnel, and will use and maintain appropriate facilities for providing the Services. When Adaptive accepts TRF and specimens from Facility that are marked to indicate Medicare coverage, Adaptive will be a “laboratory” meeting the requirements set forth in 42 C.F.R. § 410.32(d)(1)(v).
- Facility Personnel.
All TRFs submitted by Facility’s personnel to Adaptive to order Services will be ordered by a physician or other authorized personnel as specified by the Centers for Medicare & Medicaid Services in 42 C.F.R. § 410.28 and all other Applicable Laws covering Facility and the ordering of such Services in Facility’s jurisdiction.
“Confidential Information” means all confidential and proprietary information, in whatever form and whether or not marked as confidential or proprietary, disclosed by or on behalf of a Party (the “Disclosing Party”) to the other Party (the “Receiving Party”) relating to the Disclosing Party’s business, including, without limitation, customer lists, strategies, designs, technologies, trade secrets, assays, algorithms, primer designs, inventions, data, know-how, formulas, designs, drawings, photographs, documentation, forms of software or electronic media, equipment, processes, ideas, methods, concepts, facilities, plans and specifications, research and development information, and business and financial information, as well as confidential or proprietary information of third parties in the possession of the Disclosing Party. The term “Confidential Information” does not include information that (a) is in the public domain or later becomes generally available to the public through no act or omission of the Receiving Party or any of its Permitted Recipients (defined below), (b) is rightfully communicated to the Receiving Party by a third party free of restrictions on confidentiality, (c) is already in the Receiving Party’s possession free of any obligation of confidentiality as evidenced by the Receiving Party’s written records predating disclosure of the Confidential Information by the Disclosing Party, or (d) is independently developed by the Receiving Party by persons not having access to the Confidential Information of the Disclosing Party, as evidenced by the Receiving Party’s written records.
During the Term (defined below) and for a period of five years thereafter, the Receiving Party shall keep the Confidential Information in strict confidence, not reveal the Confidential Information to any third party, and not use the Confidential Information for any purpose other than to perform its obligations or assert its rights under this Agreement. The Receiving Party may disclose Confidential Information only to such of its employees, professional advisors, consultants, and agents (collectively, “Permitted Recipients”) who have a need to know the Confidential Information in connection with the Receiving Party’s performance of its obligations or assertion of its rights under this Agreement and are legally bound by confidentiality and non-use terms no less restrictive than the terms set forth in this Section 4. The Receiving Party will be responsible for any breach of this Agreement by any of its Permitted Recipients.
- Compelled Disclosure.
If the Receiving Party is required to disclose any of the Confidential Information in accordance with applicable law or the rule, regulation, or valid order of a governmental agency or court, the Receiving Party may do so without liability under this Section 4 only if the Receiving Party first, to the extent possible and permitted by law, provides the Disclosing Party with sufficient advance notice of such requirement in order to allow the Disclosing Party a reasonable opportunity to seek an appropriate protective order or other means to protect the confidentiality of the Confidential Information. In connection therewith, the Receiving Party shall use all reasonable means to assist the Disclosing Party, at Disclosing Party’s expense, in protecting the confidentiality of the Confidential Information.
- TERM AND TERMINATION.
This Agreement will come into effect on the Effective Date, and shall continue in force and effect until terminated pursuant to Section 5(b) (the “Term”).
Either Party may terminate this Agreement at any time, with or without cause, by giving 30 days’ prior written notice to the other Party. In addition to the foregoing, either Party may terminate this Agreement immediately upon written notice:
- upon the cancellation, reduction, restriction, or non-renewal of any license, certification, or insurance coverage required to operate and to fully perform its obligations hereunder;
- if the other Party becomes ineligible to participate in any federal or State health care program (including Medicare, Medicaid, and TRICARE);
- if the other Party is sanctioned or excluded by the Department of Health and Human Services Office of the Inspector General as set forth on the Cumulative Sanctions Report (http://exclusions.oig.hhs.gov/), excluded by the General Services Administration (http://www.sam.gov), or any applicable State healthcare exclusion list; or
- if the other Party becomes insolvent or seeks protection, voluntarily or involuntarily, under the bankruptcy law.
- Effect of Termination; Survival.
Termination of this Agreement by either Party will not affect the rights and liabilities of either Party that have accrued prior to the effective date of termination. The following provisions will survive termination or expiration of this Agreement: Sections 2(b), 2(c), 2(d)(iv), 3, 4, 5(c), and 7.
- OTHER CONDITIONS.
Each Party covenants, represents, and warrants to the other Party that, as of the Effective Date and throughout the Term:
- the compensation paid by Facility to Adaptive for the Services has been negotiated in an arm’s-length transaction, is not below Adaptive’s cost of such services, is applicable to all Services regardless of payer, and does not take into account the value or volume of referrals or other business generated between the Parties;
- it has not been suspended, excluded from participation in, or sanctioned under, any federal or State health care program (including Medicare, Medicaid, and TRICARE), convicted of any criminal offense related to the delivery of any medical or health care services or supplies, or related to the neglect or abuse of patients, or suspended, excluded or sanctioned under any other federal program, including by the Department of Health and Human Services Office of the Inspector General as set forth on the Cumulative Sanctions Report, or excluded by the General Services Administration as set forth on the List of Excluded Providers;
- it will notify the other Party promptly (but in any event within 15 business days) after it receives notice that it or a member of its personnel is no longer eligible to participate in any federal or State health care program, has been sanctioned by the Department of Health and Human Services Office of the Inspector General as set forth on the Cumulative Sanctions Report, or has been excluded by the General Services Administration;
- it has and will maintain current licenses necessary to perform the activities required to be provided by it hereunder;
- it has and will maintain professional and commercial liability insurance consistent with best practices prevailing in such Party’s industry;
- all consents, approvals, resolutions, authorizations, actions, or orders required of the Party for the authorization, execution, and delivery of this Agreement, and for the rights granted hereunder, have been obtained; and
- the execution and delivery of this Agreement, and the performance of its obligations hereunder do not and will not conflict with or violate any judicial or administrative order, award, judgment, or decree of any State or country applicable to such Party, or violate or conflict with any provisions of such Party’s organizing instruments, or violate or conflict with the terms of any express or implied contract between a Party and any other person or entity.
- No Requirement to Refer.
Facility and Adaptive agree and certify that this Agreement is not intended to induce, encourage, solicit, reimburse, or otherwise generate referrals of any patients or business, including any services or supplies for which payment may be made in whole or in part under any Federal Healthcare Program (e.g., Medicare, Medicaid, TRICARE). The Parties acknowledge that there is no requirement under this Agreement or any other agreement between the Parties to refer patients to each other or to any of their respective affiliates. No payment made under this Agreement will be in return for the referral of patients or business, including those paid in whole or in part by federal or State health care programs.
- Patient Privacy.
Facility and Adaptive agree to protect the privacy and provide for the security of any protected health information (as defined at 45 C.F.R § 160.103) in accordance with the Health Insurance Portability and Accountability Act of 1996, Public Law 104-191, the Health Information Technology for Economic and Clinical Health Act and all regulations promulgated thereunder at 45 C.F.R. Parts 160 and 164 (“HIPAA”), and any other Applicable Laws. Facility and Adaptive acknowledge and agree that the terms of this Agreement do not create a relationship that qualifies as a business associate relationship, as the Parties will both be providing treatment and services to applicable individuals.
- Accurate Information.
Facility represents and warrants that
- the information provided to Adaptive in New Account Set-up form and any Physician Registration Form is true and complete as of the date the relevant form is completed, and
- the information provided in each TRF will be true and complete as of the date submitted to Adaptive.
- Patient Information.
Facility will supply Adaptive with any patient information available to Facility and reasonably requested by Adaptive to process specimens for the Services under this Agreement. All disclosures of patient information will be subject to the privacy provisions set forth above.
- Patient Consent.
In the event that any patient consent is required by law in connection with one or more of the Services, Facility will be responsible for obtaining such consent, maintaining a copy thereof, and providing any copies thereof reasonably requested by Adaptive for audit purposes.
- Specimen Collection; Shipment.
Facility will be responsible for collection of all specimens in accordance with standard laboratory practices and any specific instructions provided by Adaptive regarding a specific requested test. If necessary, Adaptive will provide packaging for transporting specimens and transportation via small parcel in accordance with all Applicable Laws.
- Sample Disposition.
Upon the completion of the Services, or after 6 months from specimen receipt, Adaptive may deidentify and utilize remnant or remaining samples in assay development or dispose of the specimen, in compliance with all applicable statutes, regulations, and industry standards.
- Notice of Changes.
Each Party will promptly notify the other Party in the event any of the foregoing covenants, representations, and warranties ceases to be true and correct in all material respects during the Term.
- GENERAL PROVISIONS.
- No Implied Warranties.
Except as expressly stated in Section 6, neither Party makes any guarantees or warranties, express or implied, including warranties of merchantability, non-infringement, or fitness for a particular purpose.
- Limitation of Liability.
Neither Party will be liable for any indirect, special, incidental, punitive, or consequential damages (including claims arising from lost data and lost profits) (collectively, “Losses”), arising out of or in connection with this Agreement, however caused, and under whatever cause of action or theory of liability brought (including under any contract, negligence, or other tort theory of liability) even if such Party has been advised of the possibility of such Losses or such Losses were otherwise foreseeable. This paragraph does not apply to the payment of fees and expenses owing under this Agreement or claims arising under Sections 1, 6(d), 6(e), and 6(f). Notwithstanding any other provision of this Agreement, including but not limited to Section 7, Adaptive’s total liability under this Agreement shall not exceed amounts paid to Adaptive in the 12 months prior to the date of any claim.
The headings contained in this Agreement are for reference purposes only and will not affect in any way the meaning or interpretation of this Agreement. The Parties agree that they have been represented by counsel during the negotiation and execution of this Agreement and therefore waive the application of any law, regulation, holding, or rule of construction providing that ambiguities in an agreement or other document will be construed against the Party drafting such agreement or document.
- Independent Contractors.
The Parties are independent contractors, and they do not intend to form a partnership, joint venture, or any other form of legal association.
The rights and obligations under this Agreement may not be assigned or transferred by either Party without the prior written consent of the other Party, except that either Party may assign this Agreement without such consent to an affiliated company or in connection with the merger, consolidation, sale, or transfer of all or substantially all of a Party’s business to which this Agreement relates.
- Entire Agreement.
- Amendments; No Implied Waivers.
This Agreement may only be modified in writing, executed by duly authorized representatives of both Parties. No waiver of a breach of any provision in this Agreement will be construed to be a waiver of any breach of any other provision of this Agreement or of a succeeding breach of the same provision.
- Governing Law.
This Agreement will be governed by and construed in accordance with the law of the State of Washington, without regard to any choice of law principle that would dictate the application of the law of another jurisdiction. The Parties consent to the exclusive jurisdiction of the State and federal courts located in King County, Washington for all claims or disputes arising in connection with this Agreement.
This Agreement may be executed in counterparts and delivered via facsimile, emailed PDF, or other electronic means, each of which will be deemed to be an original, and both of which taken together, will constitute one agreement binding on both Parties.
In the event that any one or more provisions of this Agreement are, for any reason, held to be invalid, illegal, or unenforceable in any respect, such invalidity, illegality, or unenforceability will not affect any other provision of this Agreement, and all other provisions will remain in full force and effect. If any of the provisions are held to be excessively broad, any such provision will be reformed and construed by limiting and reducing it so as to be enforceable to the maximum extent permitted by law.
- No Third-Party Beneficiaries.
This Agreement will not confer any rights or remedies upon any person other than the Parties hereto and their respective successors and permitted assigns.
Unless otherwise provided herein, any notice, request, instruction, or other document to be given hereunder must be in writing delivered to the address for legal notices for such Party set forth on the Account Setup Form and will be deemed to have been given:
- if mailed, at the time when mailed, enclosed in a registered or certified postage-paid envelope,
- if sent by email, when non-automated confirmation of receipt is returned to the sender, and
- if sent by other means, when actually received by the Party to which such notice has been directed.
A Party may modify its address for notices by delivering a notice of address change in the manner set forth above. Notices of price increases by Adaptive may be effectuated as provided in the foregoing, except that automated confirmation of receipt shall be permitted for email notices.
- Intellectual Property.
No rights are granted by either Party to make or use the intellectual property (including, without limitation, the name, trade name, or trademarks) of the other Party for any purpose except as necessary in the performance by a Party of its obligations under this Agreement, or with the prior written consent of the other Party; provided, however, that each Party may identify that Facility is able to refer testing to Adaptive but only so long as such identification is brief and factual and could not reasonably be construed as an endorsement.
- Access to Records.
If Section 1861(v)(1)(l) of the Social Security Act applies to this Agreement, Adaptive agrees that, until the expiration of 4 years after the furnishing of any goods and services pursuant to this Agreement, it will make available, upon written request of the Secretary of Health and Human Services or the Comptroller General of the United States or any of their duly authorized representatives, copies of this Agreement and any books, documents, records, and other data of Adaptive that are necessary to verify the nature and extent of the costs incurred by Customer in purchasing such goods and services. If Adaptive carries out any of its duties under this Agreement through a subcontract involving a value or cost of $10,000 or more over a 12-month period, Adaptive will cause such subcontract to contain a clause to the effect that, until the expiration of 4 years after the furnishing of any good or service pursuant to said subcontract, the subcontractor will make available upon written request of the Secretary of Health and Human Services or the Comptroller General of the United States or any of their duly authorized representatives, copies of said subcontract and any books, documents, records, and other data of said subcontractor that are necessary to verify the nature and extent of costs incurred by Adaptive for goods or services under said subcontract.
- Impossibility of Performance.
No Party will be deemed to be in violation of this Agreement if it is prevented from performing any of its obligations for reasons beyond its control, including acts of God or of the public enemy, war, terrorism, flood, storm, strikes, law, or actions of any federal, State, or local government.
- No Implied Warranties.