Preamble
CEMM member companies are dedicated to providing clinical laboratory services to advance patient health and assist in patient treatment for chronic pain.  Clinical laboratory services provided by CEMM members typically are used by physicians as part of treatment for patients who suffer from chronic pain and are prescribed pain medication as part of the treatment protocol.  This Code of Conduct outlines the standards of business conduct followed by CEMM member companies to ensure that their conduct conforms to the highest ethical standards and is in accordance with all applicable laws, regulations and rules.

CEMM member companies are committed to full compliance with all applicable laws and regulations that govern their business, including but not limited to those laws, rules and regulations governing laboratory testing reimbursed by federally funded health care programs and the Clinical Laboratory Improvement Amendments (CLIA).  CEMM members companies emphasize compliance with those laws, regulations and rules that are designed to prevent fraud, waste and abuse in federally funded health care programs.

I. Compliance with Federal and State Laws and Regulations

A.  Principle
CEMM member companies are committed to compliance with federal and state laws and regulations applicable to independent clinical laboratory testing.

B.  Policy
CEMM member companies will comply with CLIA, Medicare and Medicaid program requirements, the federal False Claims Act, the federal Anti-Kickback Statute, the federal Stark Laws, HIPAA, the HITECH Act, regulations and guidance under these statutes, and state law equivalents to these statutes.

II. Establishment of Compliance Programs

A.  Principle
CEMM member companies are committed to following guidance provided by the HHS Office of the Inspector General as to establishing and implementing an effective compliance program, tailored appropriately for each member company.

B.  Policy
CEMM member companies will follow the seven elements of an effective compliance program, tailored appropriately for each member company, as set forth by the Office of Inspector General.  Specifically, a CEMM member company will (1) designate a compliance officer and compliance committee, (2) implement written policies and procedures regarding compliance obligations, (3) develop effective lines of communication (including anonymous reporting or other similar mechanism), (4) conduct effective training and education, (5) conduct internal monitoring and auditing, (6) enforce standards through disciplinary guidelines, and (7) respond promptly to detected problems and undertake corrective action.  CEMM member companies will follow the OIG Compliance Guidance for Clinical Laboratories, tailored appropriately for each member company.


III. Interactions with Healthcare Professionals

A.  Principle
CEMM member companies are committed to interacting with healthcare professionals in the best interests of patients, on the basis of scientific and clinical information about clinical laboratory testing, and in full compliance with the federal and state laws regarding interactions between clinical laboratories and health care professionals.

B.  Policy
CEMM member company relationships with healthcare professionals will be based on objective and accurate scientific research and clinical information regarding the tests and test protocols offered by the member company.  CEMM member companies will not promote the ordering of clinical laboratory tests unless it is based on medical necessity and the highest standard of care for patients.  CEMM member companies will interact with healthcare professionals and other entities in compliance with the privacy and security obligations imposed by HIPAA and the HITECH Act.

CEMM members will fully complywith the federal Anti-Kickback Statute, the Stark Laws, and equivalent state laws.

IV. Clinical Testing Quality

A.  Principle
CEMM member companies are committed to the highest level of testing standards for the accuracy and integrity of testing, consistent with all federal and state law requirements.

B.  Policy
CEMM member companies will comply with CLIA and any other applicable federal and state laws with respect to laboratory operations and equipment.  CEMM member companies ensure that their equipment, personnel, testing protocol, and quality control programs meet all applicable standards so that physicians and patients can be assured of the accuracy and integrity of test results.  CEMM member companies will not encourage physicians or other providers to perform any testing that is not in the best interest of patients, and is not in compliance with CLIA or requirements established by any federally funded health care programs.

V. Relationships with Patients and Confidentiality of Patient Information

A.  Principle
CEMM member companies will act in the best interests of its clients’ patients to promote patient education, treatment and health.  CEMM member companies will maintain the confidentiality of all information entrusted to them, except when disclosure is authorized or legally permitted or mandated.

B.  Policy
CEMM member companies will adopt policies and conduct training to ensure that the foundation of corporate conduct, in sales, marketing, operations, education, and research, is to assist in the diagnosis, treatment, and health of chronic pain patients and other patients who undergo clinical laboratory testing.  CEMM member companies will comply with the data privacy and security provisions in HIPAA, the HITECH Act, and implementing regulations, as well as state equivalent laws.  CEMM member companies will ensure that dealings with business partners, vendors, and payors are in compliance with these privacy and security provisions, through business associate agreements where required.

VI. Relationships with Payors

A.  Principle
CEMM member companies are committed to the highest standards of integrity with federal, state and commercial payors.

B.  Policy
CEMM members will ensure that their billing, coding and reimbursement practices comply with all federal and state laws, regulations, and guidance and will ensure that all claims are accurate.  All claims for tests submitted to Medicare, Medicaid or other federal health care programs will correctly identify the services ordered by the physician or other authorized person and performed by the laboratory.  Each CEMM member company will provide assistance to patients and third-party payors seeking to understand the charges associated with billed tests.  To the extent a company provides physicians with information regarding coverage or reimbursement, or any medical economics information, the information shall be objective and accurate and will be in the best interests of patients and consistent with the interests of Medicare, Medicaid and  other federal health care programs.  CEMM member companies will inform physicians and authorized practitioners that tests they order must be medically necessary, as determined by their clinical judgment and patients, and in accordance with all applicable laws, regulations, and payor policies.

VII. Education of Providers on Pain Management Science

A.  Principle
CEMM member companies are committed to developing and providing to physicians and other healthcare providers science-based information regarding medication monitoring and the testing services provided by the clinical laboratory.

B.  Policy
CEMM member companies will provide information to physicians and other healthcare providers based on objective research and valid studies, and will provide accurate information about the testing offered and the testing protocols so that clinicians can make informed decisions about testing in the best interest of their patients.  CEMM member companies will inform physicians and authorized practitioners that tests they order must be medically necessary, as determined by their clinical judgment and patients’ needs.