Terms of Service

Last updated: August 3, 2026

These Terms of Service (“Terms”) govern your access to and use of the RSM Diagnostics Lab website, Document Center materials, and online forms. By using this site, you agree to these Terms.

Informational purpose

Website content is provided for general informational and educational purposes for healthcare providers and interested visitors. It is not a substitute for professional clinical judgment, diagnosis, or treatment decisions.

Laboratory services

Ordering, specimen handling, reporting, billing, and related laboratory services are governed by applicable requisitions, account agreements, and RSM’s operational policies. Submitting a website form does not by itself create a testing relationship until confirmed by RSM.

Regulatory status and laboratory-developed tests

RSM Diagnostics Lab is a CLIA-certified high-complexity clinical laboratory (CLIA ID 08D2253750) operating under the direction of a qualified laboratory director. Certain assays offered by RSM are laboratory-developed tests validated by RSM. These tests have not been cleared or approved by the U.S. Food and Drug Administration, and the FDA has determined that such clearance is not required for laboratory-developed tests performed by CLIA-certified laboratories.

Natural agent sensitivity testing is performed in vitro for investigational and supplemental purposes. It is not a substitute for standard-of-care therapy or independent clinical judgment. All test results are intended for use by qualified healthcare professionals in conjunction with clinical evaluation.

Billing, coverage, and financial responsibility

RSM is generally out-of-network with commercial insurance carriers. Medicare may be accepted where medical-necessity documentation supports the order. Tests ordered for screening or without supporting medical necessity may not be covered, and patients may be financially responsible for non-covered services. Advance Beneficiary Notices (ABN) may be provided for Medicare tests expected to be non-covered.

All pricing is established in advance, consistent with fair market value, and is not contingent on the volume or value of any referrals.

Service area

RSM Diagnostics Lab provides laboratory services only within the United States and certain U.S. territories, subject at all times to applicable federal law, state law, territorial law, district law, payer policy, licensing requirements, laboratory regulations, professional practice standards, shipping limitations, and compliance review.

New York and California

RSM Diagnostics Lab does not offer services in New York or California. RSM will not accept, perform, process, ship, deliver, bill, or receive testing associated in any manner with New York or California, including without limitation any patient with a New York or California address, any specimen collected in, shipped from, shipped to, routed through, or otherwise connected to New York or California, or any account, practice, provider, or facility located in or operating from New York or California.

Clinic billing: purpose and structure

Any clinic billing option offered by RSM is intended solely as an administrative billing arrangement that passes on a fixed fee schedule to clinics, practices, and facilities that handle their own patient billing and collections. It is not intended, and shall not be construed, as a kickback, rebate, referral fee, commission, percentage-of-collections, or any other remuneration to induce or reward referrals, patient volume, or the use of RSM services. Notwithstanding that intended purpose, clinic billing is available only where RSM determines, in its sole discretion, that the arrangement is permissible and appropriate under the governing requirements.

Clinic billing is structured on a fixed retail price schedule that reflects the standard total market price per patient encounter, inclusive of applicable administrative and collection handling. The schedule does not vary based on the number of patients referred, the number of tests ordered, the volume of services performed, or the amount billed to or collected from any health care benefit program or patient; the same fixed price applies per patient encounter, and any separate clinic billing or collection activity is conducted by the clinic, practice, or facility on its own behalf. Even so, federal anti-kickback, all-payor anti-kickback, EKRA, anti-markup, and self-referral restrictions, as well as state law analogues, may still apply to clinic billing structures and are taken into account by RSM in determining where and how clinic billing is available.

Clinic billing may be structured in different invoicing formats depending on the account and arrangement approved by RSM. In some arrangements, RSM bills or invoices per patient encounter directly. In other arrangements, the clinic, practice, or facility collects directly from the patient at the same fixed price point applicable to that encounter, and RSM separately invoices the clinic, practice, or facility on a periodic basis for the aggregate or tallied total of those encounters over the applicable billing period. The invoicing format and timing do not alter the fixed nature of the price schedule, do not constitute a markup, rebate, or differential margin between what is collected from the patient and what is remitted to RSM, and do not change the applicability of any restriction, exclusion, or condition described in this notice. All invoicing formats remain subject to the same legal, regulatory, payer, and jurisdictional limitations set forth herein, and RSM reserves the same rights to deny, restrict, suspend, or modify any invoicing format under the conditions described above.

Jurisdictions where clinic billing may be unavailable

Clinic billing is unavailable wherever applicable law, regulation, agency guidance, payer policy, or compliance review restricts or prohibits billing by a clinic, practice, provider, facility, or intermediary for diagnostic or laboratory services performed by or sourced through an outside laboratory. Available legal and industry materials identify states that have direct-billing requirements, anti-markup limits, disclosure obligations, or related restrictions affecting provider billing for outside laboratory or pathology services, including Arizona, California, Colorado, Connecticut, Massachusetts, Nevada, New Jersey, New York, Rhode Island, Louisiana, Ohio, South Carolina, Tennessee, Indiana, Iowa, Maryland, Montana, Kansas, Washington, Florida, Illinois, Michigan, Oregon, Pennsylvania, Utah, and Virginia, and RSM may treat clinic billing as unavailable or restricted in these jurisdictions accordingly.

Clinic billing may also be unavailable, restricted, or discontinued in the District of Columbia, Puerto Rico, Guam, the U.S. Virgin Islands, American Samoa, the Commonwealth of the Northern Mariana Islands, and any other U.S. territory or possession where applicable law, territorial rules, shipping constraints, payer requirements, or compliance review do not support the arrangement.

Structure-specific and fact-specific limits

Even where clinic billing is not geographically excluded, it may still be unavailable in whole or in part depending on the specific structure and facts presented. Restrictions may apply where the arrangement involves billing by a non-performing entity, anti-markup limitations on purchased tests, direct-billing mandates, disclosure requirements for outside laboratory services, patient-residence restrictions, specimen-origin or specimen-destination restrictions, payor-specific requirements, Medicaid restrictions, test-specific rules, ownership or compensation relationships, or any other legal, reimbursement, operational, or compliance concern identified by RSM. This includes arrangements where a clinic, practice, or facility is billed a fixed approved administrative amount per patient encounter and separately handles its own patient billing and collections, if and to the extent RSM determines that the applicable jurisdiction, payor, or facts do not permit that structure.

Eligibility, discretion, and no guarantee

Where clinic billing is unavailable, RSM may require direct billing by the performing laboratory, another billing structure approved by RSM, or may decline service entirely. The availability of clinic billing is account-specific, jurisdiction-specific, fact-specific, and payor-specific, and no communication, onboarding activity, account setup, invoice format, fee schedule, or prior course of dealing shall be construed as a representation, warranty, or guarantee that clinic billing is lawful, available, approved, or reimbursable in any present or future circumstance.

RSM reserves the absolute right, at any time and in its sole discretion, to deny, refuse, restrict, suspend, modify, terminate, or withdraw clinic billing eligibility for any account, provider, practice, facility, patient, specimen, payor, test, order, jurisdiction, state, district, territory, possession, or transaction, with or without notice, whenever RSM determines that legal, regulatory, contractual, reimbursement, licensure, shipping, operational, or compliance risk may exist. RSM makes no representation that clinic billing is available except where expressly approved by RSM for the specific arrangement at issue.

Provider responsibility for billing compliance

The ordering practice, provider, and facility remain solely responsible for compliance with all applicable billing, coding, disclosure, licensure, referral, ownership, compensation, professional conduct, and payor requirements. RSM disclaims liability for denials, recoupments, overpayments, audits, investigations, penalties, sanctions, enforcement actions, disciplinary actions, shipping interruptions, or other losses arising from any billing conduct by a practice, provider, facility, or third party that is inconsistent with applicable law, regulation, policy, contract terms, or RSM instructions.

For avoidance of doubt, clinic billing is categorically unavailable for New York and California and may be unavailable in whole or in part in Arizona, Colorado, Connecticut, Massachusetts, Nevada, New Jersey, Rhode Island, Louisiana, Ohio, South Carolina, Tennessee, Indiana, Iowa, Maryland, Montana, Kansas, Washington, Florida, Illinois, Michigan, Oregon, Pennsylvania, Utah, Virginia, the District of Columbia, Puerto Rico, Guam, the U.S. Virgin Islands, American Samoa, the Commonwealth of the Northern Mariana Islands, and any other U.S. state, territory, district, or possession where applicable law, payer policy, or RSM compliance review restricts or disallows the model.

No medical advice; assumption of clinical responsibility

Site content and test information do not constitute medical advice. Ordering providers retain sole responsibility for test selection, interpretation, and patient care decisions. RSM is not liable for clinical decisions made in reliance on test results or website content.

Acceptable use

You agree not to misuse the website, attempt unauthorized access, disrupt site operations, or use content in a misleading or unlawful way. Document Center files are provided for authorized provider and partner use and should not be redistributed in a manner that misrepresents RSM or its testing.

Intellectual property

Site design, branding, text, logos, and downloadable materials are owned by RSM or its licensors. You may view and download materials for legitimate professional use related to RSM services, subject to these Terms and any stated restrictions.

Disclaimer of warranties

The website and materials are provided “as is.” To the fullest extent permitted by law, RSM disclaims warranties of merchantability, fitness for a particular purpose, and non-infringement. We do not warrant that the site will be uninterrupted or error-free.

Limitation of liability

To the fullest extent permitted by law, RSM is not liable for indirect, incidental, special, consequential, or punitive damages arising from use of the website or reliance on its content.

Changes

We may update these Terms from time to time. The “Last updated” date reflects the latest revision. Continued use of the site after changes means you accept the revised Terms.

Contact

Questions about these Terms can be sent to info@rsmdiagnosticslab.com or RSM Diagnostics Lab, 2500 Grubb Rd, Suite 120, Wilmington, DE 19810.