For more than two decades, research institutions have relied on Coverage Analyses to distinguish health insurance-billable routine costs from sponsor-obligated research expenses. This book argues that the Coverage Analysis, while essential for complying with anti-fraud laws, has been misapplied as a budgeting tool in recent years, and that the resulting coverage-centric model of clinical trial financing is no longer tenable for research hospitals under current insurance reimbursement methodologies. The Coverage Analysis remains a critical compliance tool for managing research patient charges but changes in health insurance reimbursement have made the tool outdated as a basis for financing.

Drawing on the Medicare Outpatient Prospective Payment System (OPPS) and frameworks established in the U.S. Supreme Court's Escobar and SuperValu cases, the authors demonstrate widespread misalignment of clinical research financial processes—resulting in losses to research sites and increased legal risk. At the heart of the problem is a widely held but empirically false assumption: that insurance coverage equates to insurance payment. Under OPPS, many services Medicare technically "covers" receive minimal or no separate payment, imposing hidden losses on institutions and unanticipated out-of-pocket costs for research patients.

The book advances a new payment-centric model anchored by the Research Payment Analysis (RPA)—a methodological innovation that replaces coverage determinations with empirical reimbursement data as the foundation for sponsor budget negotiations. The book argues that the RPA offers a better opportunity than a Coverage Analysis for research sites to recoup their costs through industry sponsor budget negotiations, improve time-to-activation for trials, and be on a stronger compliance footing.

Clinical Research & Health Insurance has been written for clinical research administrators, hospital revenue cycle professionals, health care lawyers, and compliance officers as well as anyone else seeking a rigorous framework for understanding the intersection of law and clinical trial financing.

"Synopsis" may belong to another edition of this title.

Rarewaves.com UK

London, United Kingdom

5-star seller

AbeBooks seller since June 11, 2025

Shipping rates from United Kingdom to U.S.A.

Item	60 to 60 business days	60 to 60 business days
First item	£ 65.00	£ 100.00

Delivery times are set by sellers and vary by carrier and location. Orders passing through Customs may face delays and buyers are responsible for any associated duties or fees. Sellers may contact you regarding additional charges to cover any increased costs to ship your items.

Payment methods

Seller's business information

RAREWAVES.COM LIMITED

Elsley Court, 20-22 Great Titchfield Street
London, United Kingdom W1W 8BE

Contact sellerView this seller's itemsView seller's storefront

Right of withdrawal

If you are a consumer you can withdraw from the contract in accordance with the following. Consumer means any natural person who is acting for purposes which are outside his trade, business, craft or profession.

Information regarding the right of withdrawal

Statutory right to withdraw

You have the right to withdraw from this contract within 14 days without giving any reason.

The withdrawal period will expire after 14 days from the day on which you acquire, or a third party other than the carrier and indicated by you acquires, physical possession of the last good or the last lot or piece.

To exercise the right of withdrawal, electronically fill in and submit a clear statement on our website, under "My Purchases" in "My Account". We will communicate to you an acknowledgement of receipt of such a withdrawal on a durable medium (e.g. by e-mail) without delay.

To meet the withdrawal deadline, it is sufficient for you to send your communication concerning your exercise of the right of withdrawal before the withdrawal period has expired.

Effects of withdrawal

If you withdraw from this contract, we will reimburse to you all payments received from you, including the costs of delivery (except for the supplementary costs arising if you chose a type of delivery other than the least expensive type of standard delivery offered by us).

We may make a deduction from the reimbursement for loss in value of any goods supplied, if the loss is the result of unnecessary handling by you.

We will make the reimbursement without undue delay, and not later than 14 days after the day on which we are informed about your decision to withdraw from this contract.

We will make the reimbursement using the same means of payment as you used for the initial transaction, unless you have expressly agreed otherwise; in any event, you will not incur any fees as a result of such reimbursement.

We may withhold reimbursement until we have received the goods back, or you have supplied evidence of having sent back the goods, whichever is the earliest.

You shall send back the goods or hand them over to Rarewaves.com UK, Unit 144 The Lightbox, 111 Power Road, W4 5PY, London, London, United Kingdom, without undue delay and in any event not later than 14 days from the day on which you communicate your withdrawal from this contract to us. The deadline is met if you send back the goods before the period of 14 days has expired. You will have to bear the direct cost of returning the goods. You are only liable for any diminished value of the goods resulting from the handling other than what is necessary to establish the nature, characteristics and functioning of the goods.

Exceptions to the right of withdrawal

The right of withdrawal does not apply to:

The delivery of newspapers, journals or magazines with the exception of subscription contracts; and
The supply of digital content which is not supplied on a tangible medium (e.g. on a CD or DVD) if you accepted when you placed your order that we could start to deliver it, and that you could not withdraw once delivery had started.

Shipping terms

Please note that we do not offer Priority shipping to any country.

We currently do not ship to the below countries:

Russia
Belarus
Ukraine

Please do not attempt to place orders with any of these countries as a ship to address - they will be cancelled.

Clinical Research and Health Insurance

Bibliographic details