A pharmacy and DME operations expert witness is a retained expert who measures how a pharmacy or a durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) supplier ran its operations against the accreditation and CMS standards in force on the date in question. Integral Healthcare Solutions (IHS) takes this work from counsel only: counsel retains IHS to measure a pharmacy's or supplier's operations against the standards then in force, and Thomas G. Goddard, JD, PhD, writes and signs the expert report.

IHS is a healthcare consulting firm, not a law firm. Nothing on this page is legal advice, and IHS does not give opinions on the Stark Law or the Anti-Kickback Statute.

What is an operations and accreditation expert in a pharmacy or DME case?

In federal court, expert testimony is governed by Federal Rule of Evidence 702, as amended effective December 1, 2023, and expert disclosure by Federal Rule of Civil Procedure 26(a)(2). Rule 702 allows a qualified expert to give an opinion if the proponent shows the court "that it is more likely than not" that the expert's specialized knowledge will help the trier of fact, that "the testimony is based on sufficient facts or data," that it "is the product of reliable principles and methods," and that the opinion "reflects a reliable application of the principles and methods to the facts of the case" (FRE 702, Cornell LII).

The 2023 committee note states that the rule was amended "to clarify and emphasize that expert testimony may not be admitted unless the proponent demonstrates to the court that it is more likely than not that the proffered testimony meets the admissibility requirements set forth in the rule" (Committee Notes on Rules, 2023 Amendment). For an operations expert, the reliable method is a documented comparison of the produced record against a named standard, in the version that applied on the relevant date.

The standards themselves depend on the organization. For a DMEPOS supplier, the federal supplier standards sit at 42 CFR 424.57, "Special payment rules for items furnished by DMEPOS suppliers and issuance of DMEPOS supplier billing privileges" (42 CFR 424.57, Cornell LII, amended through 90 FR 55607, December 2, 2025). For an accredited pharmacy or supplier, the accreditor's own standards apply, in the edition in force at the date in question.

Who needs it and what triggers it

Counsel retains an operations expert when a dispute turns on whether a pharmacy or supplier met the standards it was held to. For DMEPOS suppliers, those standards are written into federal rules. 42 CFR 424.57(c)(22) states: "All suppliers of DMEPOS and other items and services, and all of their locations whether owned or subcontracted, must meet the DMEPOS quality standards and be separately accredited to enroll in and bill Medicare" (42 CFR 424.57(c)(22)). CMS states the same requirement on its enrollment page: "DMEPOS suppliers are required to be accredited by a CMS-approved DMEPOS accreditation organization to enroll in and bill Medicare" (CMS, DMEPOS Accreditation Organizations, last modified 05/04/2026).

Matters that can turn on these standards include disputes over a supplier's accreditation status at a past date, disputes over whether written policies existed and were followed, and disputes in which a party's operations are compared with what its accreditor required. Counsel decides whether an expert is needed and what the questions are.

How IHS helps

Counsel retains IHS to measure a pharmacy's or supplier's operations against the standards then in force. The work runs in this order:

1. Conflicts check. Before any review, IHS checks the parties against its own client list.
2. Gap assessment against the governing text. IHS identifies the standards that applied on the relevant date, including the CMS supplier standards and the accreditor's standards in that edition, and reviews the produced policies, records and survey history against them.
3. Document and evidence mapping. IHS builds a chronology and maps each document in the record to the standard it bears on, so every opinion traces to specific facts or data.
4. Expert report. Thomas G. Goddard, JD, PhD, writes and signs the report, organized around the contents Rule 26(a)(2)(B) lists.
5. Deposition and trial preparation. IHS prepares for deposition and trial testimony with counsel.

What counsel supplies: the engagement letter, the produced record, and counsel's questions. Dr. Goddard supplies his own prior testimony list for the Rule 26 disclosure.

The limit: IHS opinions cover operations and accreditation standards. They do not cover clinical pharmacy judgment or medical judgment. A case that needs a clinical opinion needs a clinical expert in addition to, or in place of, IHS.

IHS describes its method here, not a record of prior matters. Any question about prior testimony is answered through the disclosure Rule 26 requires.

What to have ready

Counsel can speed the first conversation by having these items in hand:

• The names of all parties, for the conflicts check that comes before any review.
• The date or date range in question, because the standards are read in the edition in force then (FRE 702(b), "sufficient facts or data").
• The organization's accreditation status and accreditor on that date. For a DMEPOS supplier, the accreditor should appear on the CMS list of approved organizations (CMS list, updated 01/09/2026).
• The written policies and procedures in force on the relevant date, as produced.
• Survey reports, accreditation decisions and any corrective action records for the period.
• Records showing whether each location was accredited, since 42 CFR 424.57(c)(22) applies to "all of their locations whether owned or subcontracted" (42 CFR 424.57).
• A list of the materials counsel expects the expert to consider, since the report must state "the facts or data considered by the witness in forming them" (FRCP 26(a)(2)(B)).
• Any exhibits counsel expects to use, since the report must list "any exhibits that will be used to summarize or support" the opinions (FRCP 26(a)(2)(B)).
• The case schedule, including the expert disclosure date. Rule 26(a)(2)(D) says disclosures are made at the times the court orders. Absent a stipulation or court order, they are due at least 90 days before the date set for trial or for the case to be ready for trial, or within 30 days after the other party's disclosure if the evidence is solely to contradict or rebut (FRCP 26(a)(2)(D)).
• Counsel's questions, in writing.

With these in hand, the introductory call can settle scope and the conflicts check in one conversation.

How it compares

Experts in a pharmacy or DME matter can come from different disciplines, and counsel chooses among them based on the questions in the case.

Some matters use both: one expert on whether the operation met its standards, another on clinical decisions.

What it costs

We found no published fee schedule for expert work on the pages we reviewed. Rule 26(a)(2)(B) requires a retained expert's report to include "a statement of the compensation to be paid for the study and testimony in the case" (FRCP 26(a)(2)(B)), so compensation is disclosed in the report. IHS scopes each engagement after a free introductory call.

What this is not

• This is not legal advice, and IHS is not a law firm. IHS gives no opinion on the Stark Law or the Anti-Kickback Statute.
• IHS does not offer opinions on clinical pharmacy or medical judgment.
• IHS takes retention from counsel only, and an opinion follows the record. IHS does not promise any party a particular conclusion.

Frequently asked questions

What does an accreditation expert witness do in a pharmacy or DME case?

The expert compares the organization's produced policies, records and survey history with the CMS and accreditation standards in force on the date in question, then states opinions in a written report. At IHS, Thomas G. Goddard, JD, PhD, writes and signs that report and prepares for deposition and trial. Counsel retains IHS; IHS does not take retention directly from a party.

What makes an expert's testimony admissible under Federal Rule of Evidence 702 after the 2023 amendment?

Rule 702 requires the proponent to show the court that it is more likely than not that the expert's knowledge will help the trier of fact, that the testimony rests on sufficient facts or data, that it is the product of reliable principles and methods, and that the opinion reflects a reliable application of those methods to the facts. The 2023 committee note says the amendment was made to clarify and emphasize that the proponent carries that burden.

What must a retained expert's written report contain under Rule 26?

Rule 26(a)(2)(B) lists a complete statement of all opinions and the basis and reasons for them, the facts or data considered, any exhibits, the witness's qualifications including publications from the previous 10 years, a list of cases in the previous 4 years in which the witness testified at trial or by deposition, and a statement of the compensation paid for the study and testimony.

When are expert disclosures due in federal court?

Rule 26(a)(2)(D) says disclosures are made at the times the court orders. Absent a stipulation or court order, they are due at least 90 days before the date set for trial or for the case to be ready for trial, or within 30 days after the other party's disclosure if the evidence is solely to contradict or rebut. Counsel tracks the deadline that applies in the specific case.

Which standards apply to a DME supplier's operations?

Federal supplier standards are at 42 CFR 424.57. Section 424.57(c)(22) requires all DMEPOS suppliers and all of their locations to meet the DMEPOS quality standards and be separately accredited to enroll in and bill Medicare. The accreditor's own standards also apply, in the edition in force at the date in question.

Which organizations can accredit a DMEPOS supplier for Medicare?

The CMS list updated 01/09/2026 names eight organizations, each approved for the product and service categories listed for it (NABP's listing, for example, does not include Appendix B, wheelchairs and power mobility devices): ACHC; the American Board for Certification in Orthotics, Prosthetics & Pedorthics (ABC); the Community Health Accreditation Program (CHAP); the Healthcare Quality Association on Accreditation (HQAA); the Joint Commission; the National Association of Boards of Pharmacy (NABP); The Compliance Team; and the Board of Certification/Accreditation (BOC).

Can an accreditation consultant testify about clinical pharmacy decisions?

IHS opinions cover operations and accreditation standards, not clinical pharmacy or medical judgment. A matter that turns on a clinical decision needs a clinical expert for that question.

What records does an expert need to review a pharmacy's compliance at a past date?

The policies and procedures in force on that date, survey reports and accreditation decisions for the period, corrective action records, and records showing which locations were accredited. The report must list the facts or data the expert considered, so the produced record defines what the opinion can rest on.

Is IHS a law firm?

No. IHS is a healthcare consulting firm. This page is not legal advice, and IHS does not give opinions on the Stark Law or the Anti-Kickback Statute.