Acutis code of conduct

This Code of Conduct sets forth the mission and standards of conduct that all Personnel must adhere to and follow.

If you have any questions or concerns about anything covered by the Code of Conduct or about any other matter relating to the Compliance Program, or if you wish to report a concern or problem, please contact the Compliance Manager.

I. Code of conduct: values

  • At Acutis, we believe that rigorous technological processes and best practices are only fully realized when their benefits are accessible to every member of the team. Toward that end, we have built a company with no gaps, no bureaucracy, and no insurmountable hierarchy.  Every employee is fully accountable and fully accessible and should be completely willing to assume responsibility.   
     

  • The Laboratory strives to provide high-quality laboratory services for our patients without regard to age, race, color, sexual orientation, marital status, religion, sex, or national origin.
     

  • We have a commitment to conduct our business in compliance with applicable laws, rules, and regulations and in accordance with the highest ethical principles.  The Laboratory expects the same from its Personnel.  We do not and will not tolerate any form of unlawful or unethical behavior by anyone associated with the Laboratory.  We will follow the letter and spirit of applicable laws, rules, and regulations, conduct our business ethically and honestly, and act in a manner that enhances our standing in the community.

II. Code of conduct: scope of application to personnel

  • The Compliance Program - and specifically this Code of Conduct - applies to all “Personnel”
    (as that term is defined on page 2 of the Compliance Manual).

     

  • All Personnel has a responsibility to help create and maintain a work environment in which compliance concerns may be openly raised, reviewed, discussed, and addressed.

III. Code of conduct: standards

General standards

  • Personnel must be honest and lawful in all of their business dealings and avoid doing anything that could create even the appearance of impropriety.
     

  • Personnel must comply with the Code of Conduct; report any action they think maybe possibly unlawful, inappropriate, or in violation of the Code of Conduct or any compliance policy; cooperate with compliance inquiries and investigations, and work to correct any improper practices that are identified.
     

  • Acts of retaliation or intimidation for good faith reporting of any suspected violation of, or participation in, the Compliance Program will not be tolerated.



Standards related to the quality of care

  • All professional staff employed or engaged by the Laboratory will be properly licensed (and/or certified) and registered pursuant to applicable law. The Laboratory will take steps on a regular basis to monitor and ensure such compliance.
     

  • In addition to the general credentialing process, the Laboratory will screen all Personnel to ensure that they are not included on:
     

    • a) the United States Department of Health and Human Services’ Office of Inspector General’s List
      of Excluded Individuals/Entities;

    • b) the General Services Administration’s System for Award Management (“SAM”);

    • c) applicable state Medicaid excluded provider or other debarment listings; or

    • d) any other similar or successor list(s) of excluded or debarred individuals or entities
      (For example, the Laboratory will screen Personnel in New York against the New York State Office of the Medicaid Inspector General’s Medicaid Exclusion List.  Personnel in New Jersey will be screened against the State of New Jersey Consolidated Debarment Report and the State of New Jersey Medicaid Fraud Division Debarment List).

       

      The Laboratory has strict standards in place regarding the quality of care. The Director of Quality Assurance will be responsible for overseeing the quality of care issues.  The Laboratory has established processes by which quality assurance reviews are conducted, issues are addressed, and corrective actions are implemented.  In addition, the Laboratory has established protocols for reviewing complaints from patients and third parties and addressing issues that may arise.

      The Compliance Committee will meet regularly to review and discuss such topics.

 

Standards related to coding, billing and documenting services

  • Generally, the knowing submission of false claims and statements to obtain payment from Federal health care programs is punishable by criminal and civil penalties, including fines per false claim and exclusion from participating in the programs. A discussion of these laws is contained in a separate policy, entitled “Compliance with Applicable Federal and State False Claims Acts:  Overview of the Laws Regarding False Claims and Whistleblower Protections.” This policy may be found in a separate section within this manual.
     

  • All Federal and State regulations and third-party payer rules governing billing, coding, documenting, and performing tests will be fully followed for all services provided by the Laboratory. The Laboratory is committed to preparing accurate claims, consistent with such requirements. All documentation, coding, and billing for services must be accurate and truthful.
     

  • Personnel may never misrepresent charges or services to or on behalf of the government, a patient, or payer. 
    False statements, intentional omissions, or deliberate and reckless misstatements to government agencies or other payers will expose the Personnel to disciplinary action. Personnel will not knowingly engage in any form of up-coding of any service or test in violation of any law, rule, or regulation. Personnel involved in such activities are subject to termination of employment or contract, and potential criminal and civil liability.

     

  • Billing codes – including CPT, HCPCS, and ICD diagnostic codes – should never be selected on the basis of whether the given code guarantees or enhances payment.  Rather, only those codes that correspond to the actual service rendered and documented should be selected.
     

  • Government payers (and others) only reimburse for those tests that are medically necessary (i.e., reasonable and necessary for the diagnosis or treatment of illness or injury). Through its annual notice, the Laboratory educates its Personnel and ordering physicians/practitioners regarding medical necessity issues, works with physicians/practitioners to design appropriate requisition forms that include individual listings of tests in any profiles to ensure that only medically necessary tests are ordered, and conducts “reflex” or “cascade” testing in only certain limited circumstances.   
     

  • The Laboratory will bill only for tests that were ordered by a physician/practitioner and actually conducted by the Laboratory.
     

  • Tests should be performed only when there is a clear, written order from the patient’s physician/other practitioner.
    If possible, verbal orders should be accepted only infrequently, and all verbal orders must be followed by a written order as soon as practicable.

     

  • Diagnostic information on a claim form should be obtained only from the test ordering physician/practitioner or his or her designee.  If the diagnosis is unclear or has not been provided, Laboratory Personnel must contact the ordering physician/practitioner to obtain the necessary information. Personnel cannot create diagnostic information based on their own interaction with the patient, from information provided from an earlier date of service, or based on what they might conclude is the probable or most likely diagnosis.
     

  • The Laboratory will comply with all Federal and State rules relating to the retention of test orders, testing results, and billing records.

    In its billing practices, the Laboratory will comply with all Federal and State laws relating to matters including, the billing rules and requirements of all of its payers, including government payers and commercial payers.non-covered services; and gathering insurance information from patients. The Laboratory will also comply with but not limited to: waiving coinsurance amounts; obtaining Advance Beneficiary Notices from Medicare patients for


Standards relating to business practices

  • The Laboratory will forgo any business transaction or opportunity that can only be obtained by improper or illegal means, and will not make any unethical or illegal payments to induce or reward the use of our services.
     

  • No Personnel will engage, either directly or indirectly, in any corrupt business practice intended to influence the manner in which the Laboratory performs its services, or otherwise engages in its business practices.
     

  • All business records must be accurate, truthful, and complete, with no material omissions.

    Employees should not discuss with the officers, directors, or employees of competing organizations any topic that might give the impression of an illegal agreement in restraint of trade.  These prohibited topics include pricing agreements, customer allocation, and division of sales territories.



Patient referrals/marketing activities
 

  • In general, Federal and State anti-kickback laws prohibit payment to any individual or entity on the basis of the value or volume of referral of patients. This includes the giving of any form of remuneration, including virtually anything of value, in return for a referral. The decision to refer to patients is a separate and independent clinical decision made by physicians or other appropriate licensed practitioners. The Laboratory does not pay physicians, or anyone else, either directly or indirectly, for patient referrals.
     

  • All contracts, leases, and other financial relationships with providers will be based on the fair market value of the services or items being provided or exchanged, and not on the basis of the volume or value of referrals or other business between the parties.
     

  • All marketing activities and advertising by Personnel must be truthful and not misleading, must be supported by evidence to substantiate any claims made, and must otherwise be in accordance with applicable law.  In this regard, our best “advertisement” is the quality of our services. No Personnel should disparage the service or business of a competitor through the use of false or misleading representations.
     

  • All marketing activities and advertising by Personnel must be based on the merits of the services provided by
    the Laboratory and not on any promise, express or implied, of remuneration for any referrals.


    Personnel may not offer, pay, solicit or receive any gifts or benefits to or from any person or entity that would compromise the Laboratory’s integrity (or even create an appearance that compromises the Laboratory’s integrity), or under circumstances where the gift or benefit is offered, paid, solicited or received with a purpose of inducing or rewarding business between the parties.  The guiding principle is simple:  Personnel may not be involved with gifts or benefits that are undertaken to influence any business decision. Cash or cash equivalents may not be given or accepted under any circumstances.
     

Mandatory reporting
 

  • As part of its commitment to providing high-quality laboratory services, the Laboratory complies with all applicable Federal and State mandatory reporting laws, rules and regulations.  To this end, the Laboratory will ensure that all incidents and events that are required to be reported are reported in timely manner and will monitor compliance with such requirements.
     

  • The Laboratory will also ensure that it complies with annual certification requirements that may apply to its Compliance Program (for example, in accordance with New York Social Services Law and the Federal Deficit Reduction Act of 2005).
     

  • The Laboratory will ensure that all identified overpayments are timely reported, explained and returned in accordance with applicable law and contractual requirements.  It is our policy to not retain any funds which are received as a result of overpayments and to report, return and explain any overpayments from Federal health care programs within 60 days from the date the overpayment was identified (or within such time as is otherwise required by law or contract).  Any monies improperly collected are promptly refunded to the Medicare Administrative Contractor, the applicable state department of health or appropriate oversight agency (e.g., the New York Office of the Medicaid Inspector General, the New Jersey Office of State Comptroller (OSC) Medicaid Fraud Division) or another payer/agency, as applicable.
     

  • Moreover, in certain circumstances (e.g., after an internal investigation confirms possible fraud, waste, abuse or inappropriate claims), and with the advice and assistance of legal counsel, as necessary and appropriate, the Laboratory will avail itself of the appropriate self-disclosure process and report, as necessary and appropriate, to the U.S. Department of Health and Human Services, Office of the Medicaid Inspector General, an applicable state agency (e.g., the New York Department of Health, Office of the Medicaid Inspector General, the New Jersey OSC Medicaid Fraud Division) or other appropriate governmental agency.
     

    Standards relating to confidentiality and security
     

  • In compliance with Federal and State privacy laws, all Personnel will keep patient information confidential and secure.
     

  • The Laboratory has also implemented and maintains a HIPAA Compliance Program that addresses privacy and security. Personnel must adhere to the standards of the HIPAA Compliance Program.

    Confidential information acquired by Personnel about the business of the Laboratory must also be held in confidence and not used for personal gain, either directly or indirectly.
     

Government Inquiries
 

  • Personnel may speak voluntarily with government agents, and the Laboratory will not attempt to obstruct such communication. It is recommended, however, that Personnel contact the Compliance Manager or the Chief Compliance Officer before speaking with any government agents.
     

  • Personnel must receive authorization from the Chief Compliance Officer before responding to any request to disclose the Laboratory’s documents to any outside party.
     

  • It is the Laboratory’s policy to comply with the law and cooperate with legitimate governmental investigations or inquiries.  All responses to requests for information must be accurate and complete. Any action by Personnel to destroy, alter, or change any the Laboratory records in response to a request for such records is strictly prohibited and shall subject the individual to immediate termination of employment or contract and possible criminal prosecution.

Acutis Diagnostics, Inc

728 Larkfield Rd, East Northport, NY 11731
844-522-8847

Attn: Paul Han, Compliance Manager

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