Clinical trial NCT03407885: The Impact of Medicare Bundled Payments
Official title: The Impact of Medicare Bundled Payments: Evidence From a Nationwide Randomized Evaluation for Lower Extremity Joint Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty, Replacement
Lead sponsor: Abdul Latif Jameel Poverty Action Lab
Sponsor class: OTHER
Collaborators: name: Harvard University
name: University of Chicago
name: Dartmouth College
First posted: 2018-01-23
Enrollment: 196
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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.
* 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).

Primary outcomes:
measure: Share of LEJR admissions discharged to institutional Post-Acute Care (PAC)
timeFrame: At hospital discharge up to 3 days
Secondary outcomes:
measure: Share of LEJR admissions discharged to any Post Acute Care (PAC)
timeFrame: At hospital discharge up to 3 days
measure: Number of days in Institutional PAC during episode
timeFrame: Begins with index admission and ends 90 days post-discharge from index admission
measure: Total covered Medicare payments during episode
timeFrame: Begins with index admission and ends 90 days post-discharge from index admission
measure: Total covered Medicare payments for Institutional PAC during episode
timeFrame: Begins with index admission and ends 90 days post-discharge from index admission
measure: Total covered Medicare payments for any PAC during episode
timeFrame: Begins with index admission and ends 90 days post-discharge from index admission
measure: Total beneficiary payments owed out of pocket during episode
timeFrame: Begins with index admission and ends 90 days post-discharge from index admission
Other outcomes:
measure: Any THA/TKA complication
timeFrame: Begins with index admission and ends 90 days post-discharge from index admission
measure: Number of THA/TKA complications
timeFrame: Begins with index admission and ends 90 days post-discharge from index admission
measure: Share of LEJR admissions with an ER visit within 90-days of discharge from index admission
timeFrame: Begins with index admission and ends 90 days post-discharge from index admission
measure: 90-day all-cause readmission
timeFrame: 90 days post-discharge from index admission
measure: Number of covered procedures
timeFrame: Duration of hospital stay - average 3 days
measure: Complexity of patient mix for LEJR procedures, measured by patient demographics
timeFrame: Duration of hospital stay - average 3 days
measure: Complexity of patient mix for LEJR procedures, measured by patient demographics and comorbidities
timeFrame: Duration of hospital stay - average 3 days
measure: 1 year total covered Medicare payments
timeFrame: one year since index admission
measure: 1 year mortality
timeFrame: one year since index admission
measure: 1 year all-cause readmission
timeFrame: one year since index admission
measure: 1 year outpatient opioid use
timeFrame: one year since index admission
Locations:
Study officials:
affiliation: Massachusetts Institute of Technology
name: Amy N Finkelstein, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard University
name: Yunan Ji
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chicago
name: Neale Mahoney, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dartmouth College
name: Jon Skinner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Einav 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.
citation: Einav 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.