Clinical Research Value-Based Care Software

Value-Based Care in a Clinical Research Practice

A practice that runs trials alongside patient care often has the same patients in a study and in a value-based contract. Their quality measures still count. Their costs may look odd, since trial care can add visits, scans and labs. Some of that care is paid outside the plan that holds the contract. For qualifying trials, Original Medicare pays routine costs for Medicare Advantage enrollees, so the plan's own claims may not show them. In Medicaid, a state may pay trial costs outside its managed care contracts. Unlimited Systems flags enrolled participants on the panel and links them to their study, so a cost or utilization spike can be explained before a payer asks. Quality measures and care gaps are tracked during the visit, the same as for any patient. CED studies are tracked by study number, since coverage depends on being in an approved study. Shared savings sit in the same ledger as study revenue.

Why Is Value-Based Care Different in Clinical Research?

Value-based care and research overlap more than most sites expect. A participant in an oncology or cardiology trial is often also on a MIPS quality measure, an ACO panel or a payer's risk contract. The trial adds care that the contract never planned for. Without a flag on the participant, a contract manager sees a costly patient and has no way to tell that the extra spend came from a study.

Where the money flows is unusual, too. Routine trial costs for a Medicare Advantage enrollee in a qualifying trial are paid by Original Medicare, not the plan, while IDE studies stay with the plan. Medicaid programs may pay trial costs outside their managed care contracts. So the payer that holds the contract may never see part of a participant's care. Reading contract results means knowing which care sat inside the contract and which sat outside it.

Some coverage is itself a form of evidence program. Under Coverage with Evidence Development, CMS pays for certain items only for patients in an approved study or registry, and the claim must carry the study number. A site taking part is producing the evidence Medicare will use to decide future coverage. Tracking those patients and claims by study is part of value-based work, not apart from it.

What Clinical Research Value-Based Care Software Handles

Medicare Advantage routine trial costs

Original Medicare covers routine costs in qualifying trials for every enrollee, including those in Medicare Advantage plans. Participants are flagged on MA risk panels, since that care may not appear in the plan's own claims data. (CMS Medicare Managed Care Manual, Chapter 4, Section 10.7: Clinical Trials)

MA out-of-pocket maximum

The plan owes the enrollee the gap between Original Medicare and in-network cost sharing, and the in-network share must count toward the plan's out-of-pocket maximum. Staff can point participants to that rule when they ask about cost. (CMS Medicare Managed Care Manual, Chapter 4, Section 10.7: Clinical Trials)

Coverage with Evidence Development

Under CED, CMS covers some items and services only in the context of an approved clinical study. Patients in a CED study are tracked by study and coverage determination, so registry duties stay visible. (CMS: Coverage with Evidence Development)

Trial number on CED claims

Since 2014, Medicare has required a clinical trial number on claims for services in clinical trials, studies, registries and CED. Claims for CED patients are checked for that number before they leave. (CMS Medicare Claims Processing Manual, Chapter 32, Section 69: Qualifying Clinical Trials)

Medicaid managed care

States using managed care must either cover routine trial costs outside their plan contracts or write the duty into those contracts and adjust capitation. Participants in Medicaid plans are tagged with which path their state uses. (CMS State Medicaid Director Letter 21-005: Mandatory Medicaid Coverage of Routine Patient Costs in Qualifying Clinical Trials)

Commercial in-network rules

A plan may require a participant to join a trial through an in-network provider when one takes part in it. That limit does not apply to a trial run outside the participant's home state. (42 U.S.C. 300gg-8: Coverage for individuals participating in approved clinical trials)

How Does Clinical Research Value-Based Care Software Work?

1. 1. Flag participants on attributed panels

   Patients enrolled in a study are tagged on every value-based panel they belong to. Contract managers see the study, the sponsor and the dates of participation.

2. 2. Keep quality work going

   Quality measures and care gaps are tracked during each visit, trial or not. A study visit can close a gap when the care it includes meets the measure.

3. 3. Mark care paid outside the contract

   Trial care billed to Original Medicare for MA enrollees, or paid outside a Medicaid plan contract, is marked as outside the contract. Cost reviews can then set it apart.

4. 4. Track CED and registry studies

   Patients in CED studies are listed by study number and coverage decision. Missing study numbers are caught before a claim goes out, and registry tasks stay on the study's list.

5. 5. Read results with study context

   When an alternative payment model or risk contract reports results, study-level analytics show how much of the cost and use came from trial participants.

Clinical Research Value-Based Care Software vs. Generic Software

Who Uses It in a Clinical Research Practice

• Value-based care manager: Trial participants flagged on every panel, with a clear mark on care paid outside the contract.
• Research director: A list of CED and registry patients by study, with claim numbers checked and study tasks in view.
• Physician owner: Contract results that account for research, so a strong trial program doesn't look like poor cost control.