Arthroplasty, ReplacementNCT03407885
The Impact of Medicare Bundled Payments
A study testing Bundled payments for knee and hip replacement in people with Arthroplasty, Replacement, run by Amy Finkelstein.
Trial summary
Bundled payments (BP) are a key part of Medicare's shift away from the traditional fee-for-service (FFS) payment model. The investigators propose to study a nationwide randomized-controlled trial (RCT) of bundled payments for knee and hip replacements that was designed and implemented by CMS and launched in April… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthroplasty, Replacement
- What is being tested?
- Bundled payments for knee and hip replacement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Acute care hospital paid under the inpatient prospective payment system (IPPS)
- Hospital admission for major joint replacement or reattachment of lower extremity with and without major complications or comorbidities (MS-DRG 469 and 470)
Who cannot join
- MSA exclusion criteria:
- MSAs with low volume of LEJR
- MSAs with high take-up of BPCI
- MSAs with large share of LEJR in Maryland hospitals
- Hospital exclusion criteria:
- Hospitals participating in certain models of BPCI.
Show all 22Show fewer
- Patient exclusion criteria (the episode is cancelled if any of the following occurs during the episode):
- Patient not covered by both Medicare Parts A and B
- Patient eligibility for Medicare is due to end stage renal disease (ESRD)
- Patient is in a managed care plan
- Patient is in a United Mine Workers of America Plan
- Medicare is not the primary payer for the patient
- Patient dies during the episode
- Patient is re-admitted to an ACH for one of the two CJR DRGs during the episode
- Patient initiates an LEJR episode under BPCI during the episode
- Payments and services that occur in the episode that are excluded are:
- hemophilia clotting factors
- new technology add-on payments
- transitional pass-through payment for medical devices
- payments from certain incentive programs
- otherwise included payments that exceed two standard deviations of the regional mean
- services unrelated to the index admission as defined by CMS (including certain inpatient hospital stays, Part B services, and per beneficiary per month (PBPM) payments).
About this study
Official title: The Impact of Medicare Bundled Payments: Evidence From a Nationwide Randomized Evaluation for Lower Extremity Joint Replacement
Bundled payments (BP) are a key part of Medicare's shift away from the traditional fee-for-service (FFS) payment model. The investigators propose to study a nationwide randomized-controlled trial (RCT) of bundled payments for knee and hip replacements that was designed and implemented by CMS and launched in April 2016. Randomization was conducted at the Metropolitan Statistical Area (MSA) level with 67 MSAs and about 800 hospitals assigned to the treatment group. The investigators will examine the impact of bundled payments on Medicare spending, utilization, and quality. Study findings should be directly relevant for the design of payments for knee and hip replacements, two common and expensive medical procedures. Average impacts, as well as variation in impact across types of providers and markets may also shed light on economic mechanisms, which should be relevant for bundled payment initiatives under consideration for other medical services.
- Conditions
- Arthroplasty, Replacement
- Being tested
- Bundled payments for knee and hip replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bundled payments for knee and hip replacementOther
The bundled payment model holds acute care hospitals (ACHs) financially responsible for the spending and quality of an entire episode of care for two types of hospital admissions: MS-DRG 469 and 470. An episode begins with an ACH stay that results in a discharge in one of the two DRGs, and ends 90 days after discharge. Before each performance year begins, hospitals receive target prices from CMS, determined by historical hospital and regional episode expenditures. Hospitals are eligible for reconciliation payment from CMS if they spend less than the target prices for an episode, provided that they met an "acceptable" quality standard. Conversely, they are responsible for paying the difference if they spend more than the target prices.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Bundled payments for knee and hip replacement Receives: Other: Bundled payments for knee and hip replacement |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Share of LEJR admissions discharged to institutional Post-Acute Care (PAC)
Share of lower extremity joint replacement (LEJR) index admissions discharged to institutional post-acute care facilities (i.e. skilled nursing facilities (SNF), long term care hospitals (LTCH) or inpatient rehabilitation facilities (IRF)). LEJR index admissions are eligible admissions at acute care hospitals (ACH) that result in a discharge in either DRG 469 or 470.
Measured: At hospital discharge up to 3 days
Secondary outcomes (6)
Share of LEJR admissions discharged to any Post Acute Care (PAC)
Share of LEJR index admissions discharged to any PAC, which includes Institutional Post Acute Care (SNF, LTCH, IRF) plus home health agency. LEJR index admissions are eligible admissions at acute care hospitals (ACH) that result in a discharge in either DRG 469 or 470.
Measured: At hospital discharge up to 3 days
Number of days in Institutional PAC during episode
number of days in institutional PAC facilities (sum of length of stays in SNF, LTCH and IRF)
Measured: Begins with index admission and ends 90 days post-discharge from index admission
Total covered Medicare payments during episode
Total covered Medicare payments are defined as the total amount of Medicare Part A and part B Fee-for-Service (FFS) payments that are included in the bundle. Note that, as defined, total covered Medicare payments are the payments that would be made in the absence of Bundled Payments (i.e. payments that would occur under FFS Medicare). These are counterfactual for the treatment MSAs. If the data become available, the investigators plan to also look at actual payments made during the episode (which would include any reconciliation payments or repayments to or from hospitals in the treatment MSAs).
Measured: Begins with index admission and ends 90 days post-discharge from index admission
Total covered Medicare payments for Institutional PAC during episode
Measured: Begins with index admission and ends 90 days post-discharge from index admission
Total covered Medicare payments for any PAC during episode
Measured: Begins with index admission and ends 90 days post-discharge from index admission
Total beneficiary payments owed out of pocket during episode
Measured: Begins with index admission and ends 90 days post-discharge from index admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study startApr 2016
- Primary completionDec 2017
- Study completionFeb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Arthroplasty, ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amy Finkelstein
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard University, University of Chicago, Dartmouth College
- Responsible party
- Sponsor-investigator, Amy Finkelstein, Abdul Latif Jameel Poverty Action Lab
- Investigators
- Amy N Finkelstein, PhD, Principal investigator, Massachusetts Institute of TechnologyYunan Ji, Principal investigator, Harvard UniversityNeale Mahoney, PhD, Principal investigator, University of ChicagoJon Skinner, PhD, Principal investigator, Dartmouth College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03407885
- Sponsor's protocol ID
- JPAL-0740
- Status last verified
- Feb 2022
- First submitted
- 13 Oct 2017
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Finkelstein A, Ji Y, Mahoney N, Skinner J. Mandatory Medicare Bundled Payment Program for Lower Extremity Joint Replacement and Discharge to Institutional Postacute Care: Interim Analysis of the First Year of a 5-Year Randomized Trial. JAMA. 2018 Sep 4;320(9):892-900. doi: 10.1001/jama.2018.12346.
PubMed 30193277Einav L, Finkelstein A, Ji Y, Mahoney N. Randomized trial shows healthcare payment reform has equal-sized spillover effects on patients not targeted by reform. Proc Natl Acad Sci U S A. 2020 Aug 11;117(32):18939-18947. doi: 10.1073/pnas.2004759117. Epub 2020 Jul 27.
PubMed 32719129Einav L, Finkelstein A, Ji Y, Mahoney N. VOLUNTARY REGULATION: EVIDENCE FROM MEDICARE PAYMENT REFORM. Q J Econ. 2022 Feb;137(1):565-618. doi: 10.1093/qje/qjab035. Epub 2021 Sep 20.
PubMed 35233120
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Medicare Bundled Payments: Evidence From a Nationwide Randomized Evaluation for Lower Extremity Joint Replacement
- ClinicalTrials.gov ID
- NCT03407885
- Acronym / sponsor ID
- JPAL-0740
- Conditions
- Arthroplasty, Replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Amy FinkelsteinUniversity, hospital or other
- Collaborators
- Harvard University, University of Chicago, Dartmouth College
- Study start
- Apr 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Feb 2022 (actual)
- First posted
- 23 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bundled payments (BP) are a key part of Medicare's shift away from the traditional fee-for-service (FFS) payment model. The investigators propose to study a nationwide randomized-controlled trial (RCT) of bundled payments for knee and hip replacements that was designed and implemented by CMS and launched in April 2016. Randomization was conducted at the Metropolitan Statistical Area (MSA) level with 67 MSAs and about 800 hospitals assigned to the treatment group. The investigators will examine the impact of bundled payments on Medicare spending, utilization, and quality. Study findings should be directly relevant for the design of payments for knee and hip replacements, two common and expensive medical procedures. Average impacts, as well as variation in impact across types of providers and markets may also shed light on economic mechanisms, which should be relevant for bundled payment initiatives under consideration for other medical services.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Bundled payments for knee and hip replacementBundled payments for knee and hip replacement |
| Control | No intervention | –No intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Acute care hospital paid under the inpatient prospective payment system (IPPS)
- Hospital admission for major joint replacement or reattachment of lower extremity with and without major complications or comorbidities (MS-DRG 469 and 470)
Key exclusion criteria (22 listed)
- MSA exclusion criteria:
- MSAs with low volume of LEJR
- MSAs with high take-up of BPCI
- MSAs with large share of LEJR in Maryland hospitals
- Hospital exclusion criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bundled payments for knee and hip replacementThe bundled payment model holds acute care hospitals (ACHs) financially responsible for the spending and quality of an entire episode of care for two types of hospital admissions: MS-DRG 469 and 470. An episode begins with an ACH stay that results in a discharge in one of the two DRGs, and ends 90 days after discharge. Before each performance year begins, hospitals receive target prices from CMS, determined by historical hospital and regional episode expenditures. Hospitals are eligible for reconciliation payment from CMS if they spend less than the target prices for an episode, provided that they met an "acceptable" quality standard. Conversely, they are responsible for paying the difference if they spend more than the target prices. | Other | Experimental |
Primary outcome
Share of LEJR admissions discharged to institutional Post-Acute Care (PAC)
Time frame: At hospital discharge up to 3 days
Share of lower extremity joint replacement (LEJR) index admissions discharged to institutional post-acute care facilities (i.e. skilled nursing facilities (SNF), long term care hospitals (LTCH) or inpatient rehabilitation facilities (IRF)). LEJR index admissions are eligible admissions at acute care hospitals (ACH) that result in a discharge in either DRG 469 or 470.
6 secondary outcomes
Share of LEJR admissions discharged to any Post Acute Care (PAC)
Time frame: At hospital discharge up to 3 days
Number of days in Institutional PAC during episode
Time frame: Begins with index admission and ends 90 days post-discharge from index admission
Total covered Medicare payments during episode
Time frame: Begins with index admission and ends 90 days post-discharge from index admission
Total covered Medicare payments for Institutional PAC during episode
Time frame: Begins with index admission and ends 90 days post-discharge from index admission
Total covered Medicare payments for any PAC during episode
Time frame: Begins with index admission and ends 90 days post-discharge from index admission
Total beneficiary payments owed out of pocket during episode
Time frame: Begins with index admission and ends 90 days post-discharge from index admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- Results publication: PubMed 30193277Finkelstein A, Ji Y, Mahoney N, Skinner J. Mandatory Medicare Bundled Payment Program for Lower Extremity Joint Replacement and Discharge to Institutional Postacute Care: Interim Analysis of the First Year of a 5-Year Randomized Trial. JAMA. 2018 Sep 4;320(9):892-900. doi: 10.1001/jama.2018.12346.
- Results publication: PubMed 32719129Einav L, Finkelstein A, Ji Y, Mahoney N. Randomized trial shows healthcare payment reform has equal-sized spillover effects on patients not targeted by reform. Proc Natl Acad Sci U S A. 2020 Aug 11;117(32):18939-18947. doi: 10.1073/pnas.2004759117. Epub 2020 Jul 27.
- Results publication: PubMed 35233120Einav L, Finkelstein A, Ji Y, Mahoney N. VOLUNTARY REGULATION: EVIDENCE FROM MEDICARE PAYMENT REFORM. Q J Econ. 2022 Feb;137(1):565-618. doi: 10.1093/qje/qjab035. Epub 2021 Sep 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy N Finkelstein, PhD principal investigator
Massachusetts Institute of Technology
Yunan Ji principal investigator
Harvard University
Neale Mahoney, PhD principal investigator
University of Chicago
Questions about this trial
What is this clinical trial studying?
A study testing Bundled payments for knee and hip replacement in people with Arthroplasty, Replacement, run by Amy Finkelstein.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Share of LEJR admissions discharged to institutional Post-Acute Care (PAC) (time frame: At hospital discharge up to 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03407885, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2022.