Outcomes-Based & Value-Based Contracts for Medical Devices: Commercial Playbook

A comprehensive guide to structuring outcomes-based and value-based contracts for medical devices. Analyzes OIG safe harbors, Stark Law, metrics, and case studies.

As medical device manufacturers navigate an increasingly cost-conscious healthcare landscape, traditional transactional pricing models are showing their limitations. Payers, integrated delivery networks (IDNs), and group purchasing organizations (GPOs) are demanding concrete evidence that expensive medical technologies deliver on their clinical and financial promises. In response, market-access and commercial leaders are turning to alternative payment models—specifically outcomes-based and value-based contracts.

Value-based agreements (VBAs) align the financial incentives of the manufacturer with the clinical performance of the device or the total cost of care. For high-cost implants, connected health devices, novel digital therapeutics, and advanced capital equipment, these contracts offer a pathway to secure reimbursement, overcome clinical uncertainty, and accelerate hospital adoption. However, structuring these arrangements requires navigating complex data-collection bottlenecks and strict federal anti-kickback regulations.

This strategic guide provides a comprehensive playbook for medical device manufacturers. It dissects the different types of value-based contract structures, reviews real-world manufacturer precedents, analyzes the legal boundaries imposed by the Anti-Kickback Statute (AKS) and Stark Law, details outcome-measurement design, and offers a decision-making framework for commercial teams.

Scenario Question: A payer or hospital system is asking our medical device company to guarantee clinical outcomes on an expensive new implant or connected system. What value-based contract structures exist, how are outcomes measured, and what are the legal and operational risks we face?

Direct Answer: Outcomes-based and value-based device contracts tie a portion of payment, rebate, or warranty coverage to whether the technology achieves predefined clinical, utilization, or financial endpoints. According to the AMCP lexicon, these agreements fall into outcomes-based risk-share, annuity-based, subscription, or device warranty structures. Public precedents include Medtronic’s risk-sharing contracts for its Tyrx antibacterial envelope (covering replacement costs for over 140 hospitals), a Medtronic-Aetna VBA for insulin pumps linked to glycemic control, and Titan Spine’s five-year interbody-fusion warranty. Operationally, the top barrier is data access; 73% of manufacturers in the peer-reviewed AMCP survey cited the inability to obtain accurate outcome data as their primary hurdle. Legally, the HHS Office of Inspector General (OIG) December 2020 final rule created value-based safe harbors under the Anti-Kickback Statute but explicitly excluded drug and device manufacturers from the outcomes-based payments safe harbor, forcing device companies to structure these agreements under live AKS risk or utilize the narrow statutory warranty safe harbor.

1. Defining the Value-Based and Outcomes-Based Contract Landscape for MedTech

Value-based contracting is not a single transaction type; rather, it is a spectrum of risk-sharing models. While pharmaceutical value-based purchasing is heavily studied, medical devices present unique engineering and operational characteristics. Medical technologies often involve learning curves, user-dependent implantation techniques, and capital-depreciation cycles.

The Academy of Managed Care Pharmacy (AMCP) 2022 lexicon, Talking the Talk: A Lexicon for Value-Based Purchasing, provides a standardized taxonomy of value-based contract forms. When adapted to the medical device sector, these contracts partition into five primary archetypes:

Under a pure outcomes-based risk-sharing agreement, the device manufacturer and the payer or provider agree to specific clinical endpoints that the device must achieve. If the device fails to meet these endpoints in a patient or patient cohort, the manufacturer must issue a rebate, discount, or full refund. Conversely, if the device meets or exceeds the target clinical parameters, the manufacturer retains the full contract price, or in rare cases, receives a performance bonus.

Risk-Based Total Cost of Care Contracts

These agreements focus on utilization and financial endpoints rather than pure clinical markers. The contract is designed to reduce the total cost of care associated with a specific disease state or procedure. For example, a manufacturer of a novel hemodynamic monitor might contract with an IDN, agreeing to rebate a portion of the monitor's cost if post-operative ICU readmission rates do not fall by an agreed percentage across a defined patient cohort.

Annuity-Based and Spread-Payment Agreements

Typically utilized for high-cost curative technologies or capital-intensive systems, annuity models allow the payer or hospital to spread the acquisition cost of the device over several years. Crucially, these payments are often contingent on the patient remaining alive, remaining free of disease recurrence, or continuing to benefit from the therapy. If the patient dies or must undergo a revision procedure, the remaining annuity payments are voided.

Subscription and Capitated Models

Also known as the "Netflix model," subscription agreements decouple payment from the volume of individual devices consumed. The provider pays a fixed monthly or annual fee for unlimited access to a defined set of devices, software, or disposable kits. This model is common in digital health platforms, remote patient monitoring (RPM) suites, and capital-and-consumable combinations where budget predictability is the provider's primary goal.

Performance-Linked Device Warranties

A device warranty is a specific contractual guarantee that the device will not fail or require clinical intervention within a set timeframe. If the device requires revision surgery or clinical replacement due to failure or specific complications, the manufacturer bears the cost of the replacement device and, in some cases, provides financial reimbursement for the hospital's surgical costs up to a specified limit.

Table 1: Value-Based Contract Structures for Medical Devices

Contract Structure	Key Financial Mechanism	Primary Target Metric	Typical Device Application	Risk Allocation
Outcomes-Based Risk-Share	Retrospective rebates or discounts	Clinical efficacy markers (e.g., HbA1c reduction, lack of infection)	Connected devices, advanced biomaterials, active implants	Shared (performance-dependent)
Total Cost of Care	Shared savings or utilization rebates	Readmission rates, hospital length of stay, ER visits	Monitoring software, surgical instruments, care platforms	High manufacturer risk
Annuity / Spread-Payment	Multi-year installment payments	Long-term patient survival, implant patency rates	Gene therapies, high-cost structural heart implants	Shared over time
Subscription / Capitation	Fixed recurring fee for unlimited utilization	Budget predictability, patient enrollment	Remote monitoring, digital health, consumable-heavy kits	High provider utilization risk
Performance Warranty	Free replacement device + limited clinical costs	Technical device survival, lack of revision surgery	Joint implants, spinal hardware, pacemakers	Structured technical risk

2. Real-World Precedents: Public Outcomes-Based Device Contracts

Because value-based agreements are highly proprietary commercial instruments, the exact terms are rarely disclosed publicly. However, several landmark contracts have been announced or analyzed in industry literature, serving as critical precedents for the MedTech sector.

One of the most widely cited examples of a device-specific risk-sharing agreement is Medtronic’s commercial program for its Tyrx envelope. The Tyrx envelope is a mesh sleeve that holds an implantable pacemaker or defibrillator and slowly releases antibiotics to prevent surgical site infections.

To overcome hospital value-analysis committee resistance to the additional cost of the mesh, Medtronic formed risk-sharing agreements with more than 140 US hospitals and clinics. Under the terms of the VBA, if a patient receives a pacemaker or ICD wrapped in a Tyrx envelope and subsequently develops an infection requiring surgical removal and replacement of the device within a specified timeframe, Medtronic bears the cost of replacing and removing the infected device and Tyrx envelope. This shifted the hospital's financial exposure to infection-related readmissions directly onto the manufacturer.

Medtronic and Aetna Outcomes-Based Insulin Pump VBA

In the payer-facing arena, Medtronic established a value-based agreement with major insurer Aetna for its smart insulin pumps (including the MiniMed systems). In this contract, the reimbursement rate Aetna paid for the insulin pumps was linked to real-world patient outcomes.

Using aggregated, de-identified patient data transmitted via the pump's telemetry platform, the parties evaluated glycemic control (such as time-in-range and reductions in HbA1c levels) and the incidence of severe hypoglycemic events requiring emergency intervention. If patients switching from multiple daily injections to the Medtronic system did not achieve the agreed improvements, Medtronic provided retrospective rebates to Aetna. This agreement demonstrated how connected device telemetry can solve the data collection bottleneck.

Cardiac Device Performance Contracts (Abbott / St. Jude and Johnson & Johnson)

In the mid-2010s, St. Jude Medical (now Abbott) and Johnson & Johnson's Biosense Webster division pioneered risk-sharing arrangements for cardiac electrophysiology and ablation catheters. These contracts guaranteed that the hospital would achieve successful ablation of atrial fibrillation without requiring immediate repeat procedures. If a patient required a repeat ablation within a 90-day window, the manufacturer provided the secondary catheters free of charge or issued a rebate.

Titan Spine Endoskeleton Spinal Implant Warranty

Titan Spine (later acquired by Medtronic) introduced a comprehensive warranty program for its line of titanium spinal interbody fusion devices featuring surface-engineered nanotechnology. Tying the commercial value proposition directly to clinical performance, Titan Spine offered a five-year warranty to hospitals.

Under the warranty terms, if a surgeon implanted a qualifying Titan Spine interbody device and the patient required a revision surgery within five years due to a failure of the device to achieve fusion or because of device subsidence, Titan Spine provided a one-time free replacement device. To prevent kickback concerns, the warranty was structured strictly in compliance with the federal warranty safe harbor, limiting the remedy to product replacement and administrative reporting.

3. The Anti-Kickback Statute (AKS) and Stark Law: The Crucial Regulatory Trap

The single greatest hurdle to structuring a value-based device agreement in the United States is federal fraud and abuse legislation. Specifically, the federal Anti-Kickback Statute (AKS) prohibits the knowing and willful offer, payment, solicitation, or receipt of any remuneration (directly or indirectly, in cash or in kind) to induce or reward the referral of business reimbursable under federal healthcare programs (such as Medicare or Medicaid). The Stark Law similarly prohibits physician self-referrals for designated health services when a financial relationship exists, unless an exception is met.

Because a value-based contract involves financial reconciliation, rebates, free products, or warranty payments, it constitutes "remuneration" under the AKS. If a manufacturer offers a discount or rebate contingent on outcomes, or promises free replacement devices, the arrangement must be carefully analyzed to ensure it does not function as an illegal inducement to purchase the manufacturer's products.

For a deeper dive into the general enforcement environment surrounding device promotion, see our comprehensive guide on DOJ medical device fraud enforcement, False Claims Act, and Anti-Kickback.

The December 2020 OIG Value-Based Safe Harbors

In December 2020, the HHS Office of Inspector General (OIG) published a landmark final rule, Revisions to Safe Harbors Under the Anti-Kickback Statute, which became effective on January 19, 2021 (85 Fed. Reg. 77684). This rule was designed to facilitate the transition from volume-based to value-based care by establishing three new safe harbors for value-based arrangements:

Care Coordination Arrangements to Promote Value-Based Care: Protects in-kind remuneration exchanged between participants in a value-based enterprise (VBE) that is directly connected to the coordination and management of care for a target patient population.
Value-Based Arrangements with Substantial Downstream Financial Risk: Protects monetary and in-kind remuneration between a VBE and a participant, provided the participant assumes substantial financial risk from the payer.
Value-Based Arrangements with Full Financial Risk: Protects monetary and in-kind remuneration between a VBE and a participant where the VBE assumes full financial risk from a payer for the target population.

The Manufacturer Exclusion: The Safe Harbor Trap

Crucially, the OIG final rule explicitly excluded pharmaceutical manufacturers, medical device manufacturers, and medical laboratories from the definition of protected "value-based enterprise participants." The OIG justified this exclusion by stating that drug and device manufacturers are primarily sellers of products rather than direct coordinators of patient care, and that protecting their financial interactions under these safe harbors would pose a high risk of product-peddling, overutilization, and marketing fraud.

As a result, a medical device manufacturer cannot rely on the value-based safe harbors to protect an outcomes-based contract or a risk-sharing arrangement with a payer or provider. Any VBA offered by a device company must be structured outside these safe harbors and analyzed under the general statutory framework, or fit within other, pre-existing safe harbors.

Legal Pathways for Device Value-Based Contracts

Because device manufacturers are shut out of the value-based safe harbors, legal departments must utilize alternative pathways to mitigate AKS exposure:

1. The Statutory Warranty Safe Harbor (42 CFR § 1001.952(g))

The AKS contains a specific safe harbor for warranties. A "warranty" is defined as a manufacturer's written agreement to replace a defective product or refund the purchase price, provided the buyer complies with certain reporting obligations.

To fit within this safe harbor, the warranty must be limited to the product's value.
It cannot pay for the hospital's secondary clinical costs (like operating room fees, physician fees, or extended hospital stays) unless those costs are directly caused by a product defect.
The manufacturer and buyer must fully and accurately report the warranty terms, price reductions, and refunds in their cost reports to Medicare.

The Titan Spine warranty and similar implant replacement guarantees are structured to meet this safe harbor. If a manufacturer limits the VBA remedy strictly to a free replacement implant or a credit for the implant's original cost, the risk of AKS enforcement is significantly lower.

2. The Discount Safe Harbor (42 CFR § 1001.952(h))

If the value-based contract is structured as a retrospective rebate based on clinical or financial performance across a population of patients, the manufacturer may attempt to fit the arrangement under the Discount Safe Harbor.

The rebate must be structured as a reduction in the purchase price of the device.
The discount must be set in advance and clearly documented in the purchasing agreement.
The buyer (the hospital or payer) must report the discount in its Medicare cost reports, and the manufacturer must report the discount on the invoice or statement.
Importantly, the discount cannot be linked to the referral of other, unrelated products.

3. Case-by-Case Analysis and OIG Advisory Opinions

If an outcomes-based contract cannot fit within the Warranty or Discount safe harbors (for example, if it involves a connected health coaching service or pays for clinical readmission costs), the manufacturer must conduct a thorough case-by-case analysis. Sponsors often look to OIG Advisory Opinions for guidance.

The OIG has approved some manufacturer-sponsored outcomes programs through the advisory opinion process, provided the program contains strict safeguards:

The program is open to all qualified patients without physician steering.
The remuneration is not tied to the volume or value of other referrals.
The manufacturer does not pay clinicians directly for participating.
The clinical endpoints are objective, measurable, and verified by an independent third party.

4. How Are Outcomes Measured in a Device Contract?

The clinical and economic viability of a value-based agreement depends entirely on the design of the outcome metrics and the reliability of the data feeds used to track them. Unlike pharmaceutical agreements, which often rely on simple laboratory values (like cholesterol reduction or viral load suppression), medical device outcomes are highly complex and multifactorial.

A surgeon's technique, a hospital's post-operative protocol, and a patient's physical therapy compliance all influence whether an implant succeeds. If a manufacturer assumes financial risk for a clinical failure, it must ensure the contract isolates the device's performance from external variables.

The Data Bottleneck: AMCP Survey Insights

The practical difficulty of capturing clean outcome data is the primary reason why value-based device contracts remain limited in scale. In a peer-reviewed membership survey published in the Journal of Managed Care & Specialty Pharmacy (JMCP 2018), researchers surveyed 35 payers and 30 manufacturers regarding their experience with outcomes-based contracting.

Prevalence: The survey found that 20 percent of payers and 33 percent of manufacturers had at least one outcomes-based contract in place.
Interest: There was high future interest, with 71 percent of payers and 63 percent of manufacturers expressing a desire to enter into these agreements.
Renewal: For those who had successfully executed a VBA, the satisfaction rate was high, with 86 percent of payers and 80 percent of manufacturers renewing an agreement within the prior five years.
The Top Barrier: Crucially, 73 percent of manufacturers cited the "inability to obtain accurate outcome data or outcome measures" as the top barrier to executing outcomes-based contracts. Payers similarly cited the administrative burden of tracking patient outcomes.

Outcome Metric Taxonomy

To design a robust VBA, manufacturers must select metrics that are objective, audit-proof, and easily extracted from existing hospital or payer systems. These metrics generally fall into three categories:

Technical and Device-Specific Metrics

These metrics assess the physical integrity and functional performance of the device. Examples include:

Catheter occlusion or fracture rates.
Implant subsidence or migration measured via standard radiographs.
Connected battery depletion or hardware failure before the warranty period.
These metrics are highly objective and typically fit under the AKS warranty safe harbor.

Utilization and Operational Metrics

These metrics evaluate hospital resource consumption, which directly impacts the provider's bottom line under bundled payment models. Examples include:

All-cause or disease-specific 30-day hospital readmission rates.
Total ICU length of stay following a surgical procedure.
Average surgical operating room time (for devices that claim to simplify or accelerate a procedure).
These metrics require access to hospital administrative databases or electronic health records (EHR).

Clinical and Patient-Centered Metrics

These metrics measure the physiological and functional impact of the device on the patient. Examples include:

HbA1c reduction for diabetes management systems.
Reduction in pain scales (e.g., Visual Analog Scale) or improvements in functional scores (e.g., Oswestry Disability Index) for orthopedic or spinal implants.
Incidence of major adverse cardiac events (MACE) for coronary stents.
Patient-Reported Outcome Measures (PROMs) collected via validated digital health apps.

Data Capture Architectures

Manufacturers utilize three primary data architectures to support value-based contracts:

Connected Device Telemetry: The most reliable path. Connected systems, such as continuous glucose monitors (CGMs), smart pacemakers, and remote patient monitoring hubs, automatically transmit utilization and physiological data to a secure cloud platform. This bypasses the hospital’s administrative burden, providing the manufacturer with objective, real-world evidence of compliance and clinical effect.
Clinical and Device Registries: Many high-risk specialties (cardiology, orthopedics) maintain comprehensive clinical registries (e.g., the National Cardiovascular Data Registry or the American Joint Replacement Registry). If the hospital already participates in a registry, the contract can specify that registry reports will serve as the source of truth, minimizing the administrative collection burden for both parties.
Payer Claims Data: For insurer-facing VBAs, medical claims data (identified by ICD-10, CPT, and HCPCS codes) can be used to track hospitalizations, emergency department visits, and secondary revision surgeries. However, claims data suffers from a significant time lag (often 90 to 180 days) and lacks granular clinical detail.

5. How to Decide Whether to Offer a Value-Based Deal: The Commercial Framework

A value-based agreement is a powerful commercial tool, but it is not appropriate for every medical technology. Because of the high legal, administrative, and clinical-risk profile of these contracts, commercial leads must subject every candidate device to a rigorous evaluation framework.

Before proposing a value-based deal to a GPO or payer, the commercial and market-access teams must ask five gating questions:

1. Is there a clear, high-priority clinical or financial pain point?

A VBA is only useful if it solves a problem that the buyer cares about. If a hospital’s value-analysis committee is rejecting a device purely on unit price, a warranty or outcomes contract that addresses their fear of clinical failure or readmission penalties can shift the focus from acquisition cost to total cost of care. For guidance on how hospital purchasing committees evaluate these trade-offs, see our analysis of hospital value analysis committees and GPO device access.

2. Can the outcome metric be isolated from user skill and patient compliance?

If a device's clinical success is 90% dependent on the surgeon's manual skill or the patient's adherence to physical therapy, the manufacturer should not accept financial risk for clinical failure. The ideal VBA candidate is a device where the technology itself drives the outcome, or where the manufacturer provides a comprehensive training and support program that can be monitored for compliance.

3. Do we have a reliable, low-burden data feed to measure the outcome?

If tracking the outcome requires hospital staff to manually review paper charts or fill out custom surveys, the contract will fail due to administrative friction. The manufacturer must identify an existing, automated data source (such as device telemetry or registry uploads) before executing the contract.

4. What is our financial exposure under the worst-case scenario?

A manufacturer must calculate the maximum liability of the VBA. If every patient in the cohort fails to achieve the outcome, can the company absorb the retrospective rebates or replacement costs without jeopardizing its financial stability? Contracts must include clear caps on liability (e.g., rebating a maximum of 15% of total contract value or limiting replacements to 5% of the cohort).

5. Does the arrangement comply with the AKS and Stark Law?

The legal department must vet the contract structure. If the VBA cannot fit within the statutory warranty or discount safe harbors, the manufacturer must ensure that the arrangement contains robust compliance safeguards, does not involve direct payments to physicians, and is backed by a clear clinical rationale.

Figure 1: Manufacturer Value-Based Contract Decision Tree

graph TD
    A[Is the buyer rejecting the device on price or clinical uncertainty?] -->|No| B[Stick to traditional transactional pricing]
    A -->|Yes| C[Can the clinical outcome be objectively measured via automated data?]
    C -->|No| D[VBA administratively unfeasible; do not offer]
    C -->|Yes| E[Is the outcome driven primarily by the device, not surgeon skill?]
    E -->|No| F[VBA clinical risk too high; consider provider training program instead]
    E -->|Yes| G[Can the agreement fit under the Warranty or Discount Safe Harbor?]
    G -->|Yes| H[Structure contract to comply with Safe Harbor parameters]
    G -->|No| I[VBA requires custom legal structure & strict AKS safeguards]

6. Operationalizing the VBC Playbook: Step-by-Step

Once a manufacturer decides to proceed with a value-based contract, the commercial, clinical, legal, and IT teams must collaborate to execute the agreement. The operational implementation follows a structured six-step workflow:

Step 1: Feasibility and Cohort Definition

Define the target patient population. The contract must specify exact inclusion and exclusion criteria (e.g., patients aged 18-65 with a diagnosis of Type 2 diabetes and a baseline HbA1c > 8.0%). This prevents "risk creep" where the provider uses the device in off-label or high-risk populations not supported by the manufacturer’s clinical data.

Step 2: Establish the Clinical and Economic Baseline

Before the contract starts, establish the historical baseline for the target hospital or payer. If the goal is to reduce 30-day readmission rates, the parties must agree on the hospital’s historical readmission rate for that procedure using the same measurement methodology that will be applied during the VBA.

Step 3: Legal Vetting and Contracting

Draft the contract terms. The agreement must clearly define:

The precise product SKU(s) covered.
The baseline purchase price.
The target metrics and the measurement window (e.g., 90 days post-discharge).
The exact rebate, discount, or replacement remedy.
Caps on manufacturer liability.
Dispute-resolution mechanisms in case of data disagreements.
Compliance language certifying that all rebates will be reported on cost reports.

Step 4: Provider Onboarding and Training

For surgical implants or complex diagnostic systems, the manufacturer’s clinical specialists must train the hospital's staff on the standardized implantation technique or utilization protocol. The contract should specify that the warranty or outcomes guarantee is void if the device is implanted by an untrained clinician.

Step 5: Data Collection and Auditing

Set up the data transmission pipeline. If using device telemetry, configure the cloud platform to generate automated reports for both the manufacturer and the hospital’s compliance officer. If using hospital records, establish a schedule for retrospective data pulls and define audit rights allowing an independent third party to verify the accuracy of the data.

Step 6: Reconciliation and Financial Settlement

At the end of each performance period (typically quarterly or annually), aggregate the outcome data and compare it against the contract targets. The financial teams from both organizations calculate the net reconciliation. If the device failed to meet the target across the cohort, the manufacturer issues the agreed rebate checks, invoice credits, or replacement product vouchers.

FAQ: Outcomes-Based and Value-Based Device Contracts

Can a medical device manufacturer use the OIG value-based safe harbor for an outcomes contract?

No. The HHS Office of Inspector General (OIG) December 2020 final rule explicitly excluded medical device and pharmaceutical manufacturers, as well as medical laboratories, from the definition of "value-based enterprise participants" protected under the value-based safe harbors. Device manufacturers must structure these agreements under alternative legal frameworks, such as the statutory Warranty Safe Harbor, the Discount Safe Harbor, or a case-by-case Anti-Kickback Statute risk analysis.

Is a medical device warranty the same as an outcomes-based contract?

No, though they are closely related. A warranty is a narrow legal instrument protected under a specific AKS safe harbor (42 CFR § 1001.952(g)). It guarantees that the physical device will perform as designed (e.g., that a spinal implant will not fracture or migrate). The remedy under a safe-harbor warranty is strictly limited to replacing the device or refunding its purchase price.

An outcomes-based contract is broader; it can guarantee clinical patient outcomes (such as a patient remaining free of infection) or utilization outcomes (such as a hospital readmission rate), and the financial remedy may involve shared savings, performance rebates, or offsets for secondary surgical costs. These broader contracts carry higher AKS risk because they go beyond replacing the defective product itself.

Why are most value-based contracts in healthcare written for pharmaceuticals rather than medical devices?

Pharma contracts are easier to operationalize. A drug's chemical structure is static, its administration is uniform, and clinical outcomes are easily tracked via laboratory values (e.g., LDL cholesterol or viral load).

Medical devices are subject to rapid, iterative engineering cycles, and their clinical success is heavily dependent on external variables like the surgeon’s skill, the hospital’s post-operative care, and patient compliance. Furthermore, the lack of clinical blinding in device trials makes isolating the device's value case more complex. Finally, the OIG’s exclusion of device manufacturers from the value-based safe harbors has created a more cautious legal environment for MedTech compared to provider-led value-based programs.

Sources

AMCP Lexicon: Academy of Managed Care Pharmacy (AMCP). Talking the Talk: A Lexicon for Value-Based Purchasing. July 2022. Available at: AMCP Value-Based Lexicon.
OIG AKS Safe Harbors Final Rule: Department of Health and Human Services, Office of Inspector General. Medicare and State Health Care Programs: Fraud and Abuse; Revisions to Safe Harbors Under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements. 85 Federal Register 77684 (December 2, 2020). Effective date: January 19, 2021. Available at: Federal Register 2020-26072.
AMCP Outcomes-Based Survey: Journal of Managed Care & Specialty Pharmacy (JMCP). The Current Status of Outcomes-Based Contracting for Manufacturers and Payers: An AMCP Membership Survey. Vol. 24, No. 5, May 2018, pp. 410-415. doi: 10.18553/jmcp.2017.16326.
Duke-Margolis Value-Based Payment Background Paper: Duke-Margolis Center for Health Policy. Developing a Path to Value-Based Payment for Medical Products. October 2017. Available at: Duke-Margolis Value-Based Payment Background Paper.
Alshaikh et al. Reimbursement Scoping Review: Alshaikh, M. et al. Value-based procurement for medical devices: A scoping review. PMC/NCBI, February 2022. Available at: PMC8840896.
Clarivate MedTech Value-Based Healthcare Analysis: Clarivate Life Sciences. How are Medical Device Companies Responding to Value-Based Healthcare? Available at: Clarivate Life Sciences Blog.