Research Integrity & Compliance

Research Integrity & Compliance Fundamentals

Research integrity and compliance fundamentals collects the general and introductory material that underlies the more specific sub-topics in this cluster — human subjects protection, animal research oversight, biosafety, clinical trial compliance, research misconduct, conflict of interest, data security, and compliance training. It is the starting point for readers who need orientation to the field before working through a specific regulatory area. Research compliance, as a distinct administrative function, exists because research involving human participants, animals, hazardous materials, controlled technology, or federal funding is subject to a layered set of obligations: institutional policy, funder terms and conditions, and federal or international law. Compliance offices sit at the intersection of these obligations, translating regulatory requirements from bodies such as the IRB and IACUC system, the Office of Research Integrity, and their international counterparts into institutional policy and day-to-day review processes that researchers and administrators actually follow. This sub-cluster covers the shared vocabulary and structures that recur across those specific areas: what a compliance office does, how oversight committees are typically structured and charged, the difference between institutional policy and external regulation, and the basic lifecycle of protocol submission, review, approval, and monitoring that appears in one form or another across human subjects, animal, and biosafety review. Pages here are written for readers new to research compliance administration, or for those who need a cross-cutting reference point before consulting the more specific sub-clusters, each of which is grounded in the particular regulatory framework that governs it.

Guides

GTEC (Ghana Tertiary Education Commission): Accreditation Requirements and What Changed from NAB and NCTE

GTEC is Ghana’s tertiary education regulator, created by the Education Regulatory Bodies Act, 2020 (Act 1023), which merged the National Accreditation Board and the National Council for Tertiary Education. This guide covers what carried over from NAB and NCTE, the approval ladder from Institutional Authorization to Presidential Charter with GTEC’s own working-day standards and thresholds, the published fee schedule, and how to verify that a named institution, programme and campus is actually accredited.

MEAT Criteria and HCC Documentation: What CMS Actually Requires

MEAT is an industry mnemonic, not a CMS rule. This guide covers what CMS actually requires for a diagnosis to support risk adjustment, which CMS-HCC model version applies to which payment year, and why RAF recapture must happen every calendar year.

Anesthesia Medical Direction Modifiers: Choosing Between AA, QZ, QK, QY, QX and AD

A decision guide to the Medicare anesthesia payment modifiers. Which of AA, QZ, QK, QY, QX or AD applies depends on who performed the case and whether the anesthesiologist met all seven medical direction requirements in up to four concurrent rooms.

Total Time vs Face-to-Face Time: What Counts on the Date of the Encounter

Time is no longer face-to-face time and no longer needs a counselling threshold. The two enumerated lists of what counts and what does not, the calendar-date and midnight rules, split-or-shared summing, Medicare’s prolonged-services divergence, and how to document a total that survives review.

Preventive Visit and Problem Visit on the Same Day: Is There a Second Service?

A patient books a check-up and mentions a knee. Deciding whether one appointment became two billable services — the three-question test, why Medicare does not cover a routine physical at all, the AWV frequency rules behind a 24.5% overpayment rate, and the copay conversation nobody has.

Prolonged Services Time Thresholds: The Numbers, and the Two Rules

Prolonged services thresholds are determinate, published by CMS, and billed wrong constantly. The Medicare numbers for G2212, G0316, G0317 and G0318, the counting window for each E/M family, and the four rules that decide whether a given minute counts.

99417 vs G2212: Prolonged Outpatient E/M for Medicare and Everyone Else

Two codes describe nearly the same prolonged outpatient service and become reportable 14 minutes apart. CMS built G2212 in 2021 because it disagreed with how CPT defined 99417, and the disagreement has never been resolved. Verified against the current CMS HCPCS file.

Why G2211 Is Being Denied, and How to Work the Denial

Most G2211 denials come from an automated modifier 25 edit CMS instructed every MAC to build, not from a documentation failure. The causes in order of frequency, the 2025 preventive-service exception that is genuinely appealable, and why commercial payer behaviour differs.

Who Can Bill G2211 – and Who Cannot

CMS does not restrict G2211 by specialty or credential. Eligibility follows the base E/M code. The limits that do exist run along different lines: E/M family, entity type, and whether the practitioner-patient relationship is genuinely ongoing rather than discrete.

G2211 Billing Guidelines and Documentation: What CMS Actually Requires

CMS has specified no additional documentation requirement for G2211 – the obligation sits on medical necessity for the underlying E/M visit. The claim mechanics, the four categories of supporting documentation CMS names, the modifier 25 rule, and how to write a note that survives review.

New vs Established Patient: The Three-Year Rule and Its Real Qualifiers

A determinate rule that is routinely misstated as “have we seen them in three years?” The actual CPT test has four parts, and three are about the clinician: face-to-face professional service, exact same specialty and subspecialty, same group practice — plus the APP and covering rules that override the obvious answer.

Risk of Complications and Morbidity: The MDM Column With No Numbers

Column 3 scores the risk of your management, not the risk of the condition. What “prescription drug management” really requires, how the minor/major/elective/emergency surgery ladder works, the narrow definition of intensive toxicity monitoring, and why decisions to forego treatment count.

Split (or Shared) E/M Visits: Who Bills, and What the Record Must Show

In a facility setting, the practitioner who performed the substantive portion bills the visit – more than half the total time, or the substantive part of the MDM. Modifier FS is required, and the note must name who did which.

Chronic Care Management vs the Office Visit: Which Minutes Go Where

CCM is a monthly, largely non-face-to-face service; the office visit is separate and separately payable. The eligibility test, the code and time structure, the initiating-visit requirement, and the concurrent-billing combinations CMS forbids.

Amount and Complexity of Data: The MDM Column Auditors Recount

The only MDM column with arithmetic in it, and the one that produces most downgrades. What “unique” test and “unique source” actually exclude, why a whole hospital records packet is one element, when a discussion counts, and the rule that removes anything you separately reported.

Dermatology E/M on a Procedure Day: What the Minor-Procedure Rule Absorbs

The decision to perform a minor procedure is paid for inside the procedure. A same-day dermatology E/M is reportable only if it is significant, separately identifiable and unrelated to that decision – and new-patient status does not qualify it.

Well-Child and Problem Visit on the Same Day: Billing Both Correctly

CPT permits reporting a preventive medicine service and a problem-oriented office visit at the same encounter, with modifier 25 on the office visit. The threshold is additional work, and the modifier goes on the E/M – not the preventive code.

Number and Complexity of Problems Addressed: The First MDM Column

Column 1 of the MDM table looks intuitive and is not. Every term has a CPT definition that differs from clinical usage — above all “stable”, which turns on the individual treatment goal, not on whether anything has changed. A definition-by-definition walk with worked examples.

G2211: The Visit Complexity Add-On Code, and When It Actually Applies

G2211 is Medicare’s add-on code for visit complexity inherent to an E/M service. It describes a longitudinal practitioner-patient relationship, not a clinical condition. What it pays, which base codes it attaches to, the modifier 25 restriction, and the 2026 expansion to home and residence visits.

E/M With a Psychotherapy Add-On: Why Time Cannot Select the Level

When a psychotherapy add-on code (90833, 90836, 90838) is reported with an office visit, the E/M level must be selected on medical decision making alone. Time is barred, prolonged services are barred, and the note must state minutes for each service separately.

The MDM Table: How the Level of Medical Decision Making Is Actually Decided

History and exam no longer select the E/M level — the Levels of Medical Decision Making table does. A column-by-column walk through the governing AMA text: the three elements, the 2-out-of-3 rule, the asymmetric data thresholds, and a worked encounter mapped onto the table.

Modifiers GT and G0: What Is Left of the Old Telehealth Modifiers

GT was eliminated for professional Medicare telehealth claims from January 2018 – but the Claims Processing Manual still requires it on critical access hospital Method II claims, in an instruction revised in 2024. G0 is a live acute-stroke modifier, and GQ survives only in Alaska and Hawaii.

Modifier 32: Mandated Services, and Why It Does Not Create Coverage

Modifier 32 reports a service required by a third party rather than requested by the patient or ordered for diagnosis. It is informational only under Medicare, and the examinations it most often describes are expressly excluded from the benefit – which makes it a GY question, not a GA one.

Modifier 47: Anesthesia by the Surgeon, and What It Cannot Do

Modifier 47 says the surgeon gave the regional or general anesthesia for their own procedure. It goes on the surgical code, never on an anesthesia code, and under CMS anesthesia rules it does not generate a separate payment.

Modifier 33 and Modifier PT: Deciding When a Service Is Preventive

Modifier 33 says a service was preventive; modifier PT says a colorectal screening became diagnostic. They belong to different rule systems, they move patient cost-sharing rather than payment, and they must not appear on the same claim line.

Modifiers 80, 81, 82 and AS: When an Assistant at Surgery Is Payable

Choosing between 80, 81, 82 and AS is the easy part. Whether an assistant is payable at all is decided by the fee schedule indicator, a five percent national frequency rule, and – in a teaching hospital – whether a qualified resident was available. Three denial routes, three different liability outcomes.

Modifiers 73 and 74: The Facility Side of an Abandoned Case

Modifier 73 reports a facility procedure stopped before anesthesia, modifier 74 one stopped after it, and the OPPS payment differs sharply. They are the facility counterparts to 52 and 53 – and the professional and facility claims for one abandoned case will legitimately carry non-corresponding modifiers.

Modifier 90: Reference (Outside) Laboratory and Who May Bill

Modifier 90 identifies a test the billing laboratory did not perform. Whether it may bill at all is a statutory question decided before the modifier is chosen — the 30 percent rule, specialty code 69, two CLIA numbers on the claim, and how 90 differs from 91, 26 and TC.

Modifiers GX, GY and GZ: The Liability Decision Against GA

GA, GZ, GY and GX are one decision, not four modifiers. Two questions settle it: is coverage in doubt on medical necessity or statutory exclusion, and was a notice issued. The matrix, the CARC and Group Code each denial produces, and why a GZ line is the one that gets noticed.

Modifiers 62 and 66: Co-Surgeons and the Surgical Team

Modifier 62 reports two surgeons of different specialties performing one procedure; modifier 66 reports a team of more than two. Both turn on a fee schedule indicator most claims never check. The decision rule, the payment consequences, and how both differ from assistant-at-surgery modifiers 80, 81, 82 and AS.

Modifier 52 vs 53: Reduced Service or Discontinued Procedure

Modifier 52 reports a service the physician deliberately reduced; modifier 53 reports one stopped because continuing threatened the patient. The distinction decides the modifier, the documentation and the payment — and neither applies on a facility claim, where 73 and 74 take over.

Modifier 79: The Unrelated Procedure Inside a Global Period

Modifier 79 asserts that a procedure performed inside someone else’s global period had nothing to do with the original surgery. When that is defensible, why a new postoperative period begins, and how 79 differs from 24, 58, 78 and 76.

Modifier 78: The Unplanned Return to the Operating Room

Modifier 78 reports an unplanned return to the operating room for a related procedure during a global period. What CMS counts as an operating room, why the payment is limited to intra-operative value, why the global period does not restart, and 78 versus 58, 79 and 76.

Modifier 58: Staged or Related, and the New Global Period

Modifier 58 says the second procedure in the global period was staged, more extensive, or therapy following a diagnostic service — not a rescue. When that is defensible, why a new postoperative period begins, and how 58 differs from 78, 79, 76 and 22.

Modifier 95 vs 93: Choosing the Telehealth Modifier and Place of Service

Modifier 95 denotes real-time audio and video; modifier 93 denotes audio-only and functions as a regulatory attestation. How 95, 93, FQ and GQ pair with POS 02, 10 and 11, and which parts of the rule rest on short-term extensions.

Modifier 91: The Narrowest Repeat Rule in Lab Billing

Modifier 91 covers only repeats where multiple results were genuinely needed in the course of treatment — never a confirmatory rerun, never a specimen or instrument problem. The panel-component use that makes it worthwhile, what the record must show, and why it is not modifier 76.

Modifier 22: The Documentation Is the Claim

Modifier 22 asks a payer to pay more than the fee schedule on the strength of a narrative. What the concise statement must contain, the three generic phrases contractors reject outright, why an undocumented modifier 22 pays the ordinary rate silently, and the one NCCI edit route it opens.

Modifier GA: Shifting Liability With an ABN on File

Modifier GA asserts that an Advance Beneficiary Notice was issued before the service, shifting liability to the beneficiary if Medicare denies. When it is defensible, why GA lines go in as covered charges, the notice defects that void it, and GA versus GZ, GX, GY and KX.

Modifiers JW and JZ: Billing Drug Wastage Defensibly

Since July 2023 a single-dose container drug claim must say either JW (this much was discarded) or JZ (none was). The discard definition, the billing-unit rule that makes JW impermissible, what the record must show, and why the JW quantity should reconcile with your hazardous-drug waste documentation.

Modifier 50: Bilateral Procedures Without the Denial

Most modifier 50 denials come from three fixable things: a code that was never eligible for a bilateral adjustment, a claim built in the wrong shape, or an MUE that rejects the units first. The bilateral indicators, the Medicare-versus-CPT split on line construction, and why bilateral is never modifier 59.

Modifier 76: When a Same-Day Repeat Is Actually Billable

Modifier 76 distinguishes a genuine same-day repeat from a duplicate claim line. When it is defensible, why equipment failure and technical redos never qualify, why it will not clear an NCCI edit or a date-of-service MUE, and how it differs from modifiers 91, 77 and 78.

Modifier 57: Decision for Surgery, and Why It Is Not Modifier 25

Modifier 57 carves the decision-to-operate visit out of a major surgery global package. When it is defensible, why it never applies to minor procedures, what the note must show, and the exact line that separates it from modifier 25.

Modifier 26 and TC: Splitting a Diagnostic Service Correctly

Global, professional component, or technical component — one decision with three answers. How the PC/TC indicator settles whether 26 and TC are permitted at all, why hospital TC billing gets recouped, the anti-markup limitation, and where clinical lab tests fall outside the split entirely.

Modifier 51 vs Modifier 59: Which Question Are You Answering?

Modifier 51 reduces payment on secondary procedures; modifier 59 unlocks payment blocked by a bundling edit. When 51 applies, why several MACs tell you not to append it, the multiple-surgery indicators that set the reduction, and a decision test that separates 51 from 59.

Modifier KX: What You Are Actually Attesting To

Modifier KX attests that the requirements in an applicable medical policy have been met — but which policy varies entirely by item and jurisdiction. The therapy threshold, DMEPOS LCD criteria, what the record must show, and why KX and GA are opposite positions.

Modifier 24: When a Post-Op E/M Is Defensibly Unrelated

Modifier 24 asserts that an E/M inside a surgical global period was unrelated to the surgery. When that assertion is defensible, what the record must show, why complication management never qualifies, and how it differs from modifiers 25, 57, 79, 58 and 78.

Modifier 59 vs the X{EPSU} Modifiers: Deciding What Is Defensible

You reach modifier 59 because an NCCI edit already fired. Whether appending it is defensible, and whether XE, XS, XP or XU is required instead, turns on which single fact the record supports. The four criteria, the three same-encounter exceptions, which code carries the modifier, and what OIG found when it audited.

Modifier 25: Deciding Whether the Same-Day E/M Is Separately Identifiable

Modifier 25 asserts that a same-day E/M was significant, separately identifiable, and above and beyond the work already inside the procedure code. The test CMS applies, when modifier 57 or 24 is correct instead, the three situations where your MAC will ask for documentation, and how the decision differs from modifier 59.

Title IX Investigation Procedure: What the Current Rule Requires

A step-by-step look at Title IX grievance procedure under the currently-operative 2020 rule (34 CFR Part 106): actual knowledge, formal complaint, live hearing and cross-examination, standard of evidence, appeal, and where the vacated 2024 rule stands as of the check date on this page.

Title IX Coordinator: Role, Responsibilities, and Authority

A guide to the Title IX Coordinator role required under 34 CFR Part 106: core responsibilities, who must have one, independence requirements, and how it differs from Clery compliance, EEO/Title VII, and ombudsperson roles.

Clery Act Compliance: CSAs, Geography, and the Annual Security Report

A practical guide to Clery Act compliance: who counts as a campus security authority, what Clery geography includes, which crimes must be reported, and how the Annual Security Report and daily crime log work under 34 CFR 668.46.

What Is Sri Lanka’s University Grants Commission (UGC)?

Sri Lanka’s University Grants Commission (UGC): its statutory role, recognized universities and degree-awarding institutes, biannual research grant scheme, and the z-score admission system.

UGC Nepal: What the University Grants Commission Does

Nepal’s UGC funds universities and faculty research, runs quality assurance, and certifies foreign-degree equivalence — spread across four separate portals. Here’s what each one covers and does.

Anti-Intellectualism and Public Trust in Science: What the Evidence Actually Shows

Beyond the dictionary definition: what Pew, Wellcome Global Monitor and Eurobarometer data show about trust in science, why the deficit model fails, and how researchers should respond to public skepticism.

What Is CUE? Kenya’s Commission for University Education

How Kenya’s Commission for University Education (CUE) licenses universities, grants charters and Letters of Interim Authority, accredits programmes, and differs from NACOSTI’s research-permitting role.

What Is Bangladesh’s University Grants Commission (UGC)?

Bangladesh’s UGC is the statutory apex body for higher education: it funds public universities, approves and supervises private ones, and is now facing a live proposal to replace it. Not to be confused with India’s UGC.

What Is CHED? The Philippines’ Commission on Higher Education

CHED regulates Philippine higher education institutions and programs through CHED Memorandum Orders (CMOs), accreditation and COE/COD designation, and transnational-education rules — and funds HEI research separately from DOST.

What Is Nigeria’s National Universities Commission (NUC)?

The NUC is Nigeria’s statutory university regulator: it licenses universities, accredits academic programmes under the CCMAS curriculum standard, and approves postgraduate programmes. Here is what it does, how accreditation works, and how it differs from TETFund and NAFDAC.

How Institutions Staff a Research Integrity Office: RIO, Compliance Director, Research Protections Director

How research-intensive institutions split the research-integrity-and-compliance function into a Research Integrity Officer, Research Compliance Director, and Research Protections Director, with a real 2024 institutional restructuring example.

The Institutional Official (IO): One Role Across IACUC, Research Security, and Misconduct Oversight

The Institutional Official (IO) is the senior signatory who binds a research institution to its federal assurances and certifications across IACUC/animal research, misconduct oversight, and research security — distinct from the RIO, DIO, and Research Security Officer roles that report to it.

Council on Governmental Relations (COGR): What It Is and Its Role in Research Policy

An overview of the Council on Governmental Relations (COGR): what it is, who it represents, and its role in federal indirect-cost, compliance, and research-security policy for U.S. research institutions.

Is NIH Research Peer Reviewed? Grant Review vs. Journal Peer Review

NIH grant applications go through their own scientific peer review (study sections) before funding. The resulting research findings go through a separate, unrelated journal peer review before publication. Here’s how the two differ.

Research Integrity Fundamentals: FFP, RCR, and the Misconduct Process

An orientation to research integrity as a field: how it differs from research ethics and compliance, the FFP misconduct framework, RCR training, and how misconduct investigations actually work.

The Seven Elements of an Effective Compliance Program, Applied to Research Compliance

How the OIG’s seven-element compliance-program framework, drawn from the Federal Sentencing Guidelines and HHS-OIG guidance, maps onto a university research-compliance office’s actual risk areas: misconduct, human subjects, export control, COI, and effort reporting.

NIH’s Simplified Review Framework: What Changed in Grant Peer Review Scoring

NIH’s Simplified Review Framework reorganizes the five RPG peer-review criteria into three factors, effective for application due dates from January 25, 2025.

Sole-Source Justification Letter: Format, Required Elements, and a Worked Example

A sole-source justification letter documents why a purchase using federal award funds is being made from a single vendor without competitive bidding. This guide covers the required elements under 2 CFR 200.320, common justification grounds, review expectations, and a worked structural example.

Federal Grant Closeout: The Process and a Practical Checklist

A practical guide to federal grant closeout under 2 CFR 200.344 — the reporting deadline, final financial and technical reports, property and equipment disposition, patent/invention reporting, record retention, and a step-by-step checklist.

Federal Grant Compliance Checklist: The Practical Basics

A lifecycle-ordered checklist that ties together CASRAI’s individual guides on Uniform Guidance, effort reporting, subawards, F&A rates, and audit prep into one practical overview of what federal grant compliance actually requires day to day.

What a Research Administrator Does: The Role Explained

What research administration is as a field, and what research administrators actually do (pre-award, post-award, or both) — where the role sits organizationally, the skills it requires, and how it connects to CASRAI’s identifier and compliance standards.

NIH Modular Budgets: How Proposal Budget Development Works

How NIH’s modular budget format works: $25,000 increments, the $250,000 direct-cost threshold, when a detailed budget is required instead, and what justification NIH still requires (personnel effort, itemized consortium/subaward costs) even in a modular submission.

Departmental vs. Central Sponsored Programs Office: How Research Administration Is Organized

How universities organize research administration: departmental (distributed) staff embedded in academic units vs. a central sponsored programs office (SPO/OSP), the hybrid hub-and-spoke model, and how this differs from the pre-award/post-award functional split.

Subaward Agreement Negotiation: How It Works

A practical walkthrough of subaward agreement negotiation between a prime awardee and a subrecipient institution: what gets negotiated, common friction points, and where standardized templates fit.

Institutional Internal Controls for Federal Grant Compliance

What 2 CFR 200.303 requires, the five components of an effective internal control system, and how weak controls surface as Single Audit findings.

Pre-Award vs. Post-Award Office Roles: How the Functions Split

A functional breakdown of pre-award (proposal, budget, submission, compliance review) versus post-award (financial administration, monitoring, reporting, closeout) office roles in sponsored-programs administration, and how researchers interact with each across the grant lifecycle.