HCR 575 Module 3 Assignment 2: Coverage Analysis Example

Course	HCR 575 Management and Negotiation of Clinical Trial Budgets and Contracts
Module	Module 3
Paper type	Medicare coverage analysis
Length	About 607 words, 5 pages
Format	APA 7 student paper
School	Arizona State University
Program	MS in Clinical Research Management
Updated	October 2026

Free sample paper for HCR 575 Module 3

Medicare Coverage Analysis for Protocol LUNG-302: Qualification, Billing Grid and Rationale

Student Name

MS in Clinical Research Management, Arizona State University

HCR 575: Management and Negotiation of Clinical Trial Budgets and Contracts

Instructor Name

Month Day, Year

What this page is doingThe title follows how coverage analyses are labeled at research sites, naming the protocol and the three parts.

Medicare Coverage Analysis for Protocol LUNG-302: Qualification, Billing Grid and Rationale

Purpose

A coverage analysis protects participants from improper charges, protects the site from billing errors that can become false claims (31 U.S.C. § 3729) and tells the budget team which costs the sponsor must cover. It has two parts: deciding whether the trial qualifies for Medicare coverage of routine costs and then classifying every item and service in the protocol's schedule of events (Pfeiffer & Windscheigl, 2021).

Step 1: Qualifying the Trial

Medicare's Clinical Trial Policy covers routine costs in qualifying clinical trials (Centers for Medicare & Medicaid Services [CMS], 2007). A trial qualifies if it evaluates an item or service in a Medicare benefit category, has therapeutic intent and enrolls patients with the diagnosed disease, and certain trials, including those conducted under an investigational new drug application reviewed by the FDA, are deemed to meet the policy's desirable characteristics.

Conclusion: LUNG-302 is a qualifying clinical trial, so routine costs may be billed to Medicare and, under the parallel requirements of most commercial plans and state law, to insurers.

Criterion	LUNG-302	Met?
Medicare benefit category	Chemotherapy and its administration are covered services	Yes
Therapeutic intent	Aims to improve survival in advanced lung cancer	Yes
Enrolls diagnosed patients	Adults with stage IV non-small cell lung cancer	Yes
Deemed status	Conducted under an FDA-reviewed IND	Yes

Step 2: The Billing Grid

Item or service	Visit	Billing	Rationale
Investigational drug	Every cycle	Sponsor provides	Investigational item; never billed
Carboplatin and pemetrexed	Every cycle	Routine (insurance)	Standard of care for this disease
Drug administration	Every cycle	Routine for standard drugs; sponsor for study drug infusion time	Administration of the investigational drug is a study cost
Complete blood count	Day 1 of each cycle	Routine	Required for safe chemotherapy in usual care
Comprehensive metabolic panel	Day 1 of each cycle	Routine	Usual care monitoring
Pharmacokinetic blood draws	Cycle 1 Days 1, 2 and 8	Sponsor	Done only for study purposes
CT scans of chest, abdomen and pelvis	Every 6 weeks	Routine every 9 weeks; sponsor for the extra scans	Usual care images less often; added frequency is for research
Electrocardiogram	Screening and cycle 1	Sponsor	Not usual care for this regimen
Patient-reported outcome questionnaires	Every cycle	Sponsor	Research only
Treatment of adverse events	As needed	Routine	Medicare covers complications of a qualifying trial

What this page is doingSplitting the CT scans into a routine portion and a research portion shows the reasoning a billing auditor expects.

Rules Applied

Three rules guided each line. First, items the sponsor provides free of charge, such as the investigational drug, cannot be billed to anyone. Second, items and services provided solely for data collection, such as pharmacokinetic draws and research questionnaires, are not routine costs and fall to the sponsor. Third, when the protocol requires a service more often than usual care, only the usual-care frequency is routine; the extra occurrences are research costs. Usual care was documented from the national guideline for this disease and the site's own practice, and the documentation is kept with the analysis.

Budget and Billing Implications

The sponsor-paid items in the grid feed directly into the budget: pharmacokinetic draws, extra CT scans, electrocardiograms, questionnaire time and investigational drug administration. Claims for routine items must carry the clinical trial modifier and condition code with the trial's identifier so payers can identify them. The analysis will be updated with every protocol amendment that changes the schedule of events.

Conclusion

LUNG-302 qualifies for coverage of routine costs, and the grid separates routine care from research costs line by line. Done before the budget is negotiated, the analysis protects participants from improper bills and the site from compliance risk, and it gives the budget team a defensible list of costs to ask the sponsor to pay.

References

Centers for Medicare & Medicaid Services. (2007). National coverage determination for routine costs in clinical trials (310.1). https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?ncdid=1

False Claims Act, 31 U.S.C. § 3729 (2024).

Pfeiffer, J., & Windscheigl, M. (2021). Managing clinical trials: Budgets and contracts (2nd ed.). LAD Publishers.

Reading the HCR 575 Module 3 assignment instructions

Assignment 2 in HCR 575 is due in Week 3, the coverage analysis week, and it is worth 100 points. The course description lists coverage analysis among the core skills of clinical trial budgeting: deciding, for every item and service in a protocol, who is responsible for payment. A coverage analysis starts by establishing whether the trial qualifies under Medicare's Clinical Trial Policy, then works through the schedule of events, classifying each item as routine care billable to insurance, a sponsor-paid research cost or an item the sponsor provides free that must never be billed. Every classification needs a rationale, usually a reference to standard of care documentation. The textbook, Pfeiffer and Windscheigl's Managing Clinical Trials: Budgets and Contracts, walks through the method, and your instructor will supply or describe the protocol in Canvas. The result feeds the final budget in Week 4.

How this HCR 575 Module 3 example is built

The sample states the purpose of a coverage analysis in two sentences and cites the course text for its two parts. Step 1 qualifies the trial in a table that tests each criterion of the Medicare policy and states a conclusion. Step 2 is the billing grid, one row per item or service, with visit timing, billing assignment and rationale, including a split between routine and research frequency for scans. A section explains the three rules applied throughout, and a short section draws out budget and billing implications, including claim coding and updates for amendments. The conclusion restates why the analysis matters before budget negotiation. The grid is the part a billing office uses daily, so it is kept clear.

HCR 575 Module 3 rubric: what earns full marks

One hundred points go to the coverage analysis. Top marks need an analysis that qualifies the trial correctly under Medicare's Clinical Trial Policy, classifies every item in the schedule of events with a clear rationale, distinguishes free investigational items, research-only services and routine care, handles extra-frequency services correctly and links the results to the budget and to billing practice. Points are lost when items are classified without rationale, when research-only procedures are billed to insurance, when standard of care is assumed rather than documented and when the qualification step is skipped. Readers value analyses that show their usual-care sources, since an undocumented coverage analysis cannot defend a site in an audit.

HCR 575 Module 3 help with common mistakes

Start with the qualification test; if the trial does not qualify, nothing is routine. List every item in the schedule of events before classifying any. Document usual care for each routine item from a guideline or the site's practice. Split items done more often than usual care. Never bill the investigational product or anything the sponsor pays for. Note claim coding requirements. Keep the analysis tied to the protocol version. If your protocol's standard of care is unclear, the desk can help you find guideline sources. Date the analysis and note the protocol version it reflects. Ask the billing office to review the grid before the budget is finalized.

Write yours, or have the desk draft it

This paper is an original model document written by our desk, not a submitted student paper and not an official Arizona State University document. Read it for the moves, then write your own to the instructions in your classroom. If you want one built to your exact prompt and rubric, the first custom sample is free and arrives in 24 to 48 hours.

More HCR 575 and MS in Clinical Research Management sample papers

HCR 575 Module 3 questions, answered

Where can I find a free HCR 575 Module 3 sample paper?

This page has a full HCR 575 Assignment 2 coverage analysis for a Phase 3 lung cancer trial.

What is a clinical trial coverage analysis?

A review that qualifies a trial for Medicare coverage of routine costs and classifies each study item as billable, sponsor-paid or free.

What makes a clinical trial qualify under Medicare's Clinical Trial Policy?

A Medicare benefit category, therapeutic intent, enrollment of diagnosed patients and desirable characteristics, which IND trials are deemed to meet.

Can research-only tests be billed to insurance?

No. Services done only to collect study data are sponsor costs, not routine care.

Which textbook does HCR 575 use?

Pfeiffer and Windscheigl's Managing Clinical Trials: Budgets and Contracts, second edition.