The Impact of Medicare Bundled Payments

Arthroplasty, Replacement Clinical Trial

Official title:

The Impact of Medicare Bundled Payments: Evidence From a Nationwide Randomized Evaluation for Lower Extremity Joint Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03407885
• Other study ID #: JPAL-0740
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: February 2022

Study information

• Verified date: February 2022
• Source: Abdul Latif Jameel Poverty Action Lab
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: February 2022
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Arthroplasty, Replacement

Intervention

Other:
• Bundled payments for knee and hip replacement
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.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Amy Finkelstein	Dartmouth College, Harvard University, University of Chicago

References & Publications (3)

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 2 — View 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;32 — View Citation

Liran Einav, Amy Finkelstein, Yunan Ji, Neale Mahoney, Voluntary Regulation: Evidence from Medicare Payment Reform, The Quarterly Journal of Economics, Volume 137, Issue 1, February 2022, Pages 565-618, https://doi.org/10.1093/qje/qjab035

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Any THA/TKA complication	The total hip arthroplasty/total knee arthroplasty (THA/TKA) complication measure is a facility-level risk-standardized 90-day complication rate for total hip and total knee arthroplasty and is part of the targeted quality measure. However this component of the targeted quality measure is a three-year moving average. While it may not be feasible to replicate the measure, the investigators will code the underlying the eight "complications", which are heart attack, pneumonia, or sepsis/septicemia/shock within seven days of admission, surgical site bleeding, pulmonary embolism, or death within 30 days of admission, and mechanical complications or periprosthetic joint/wound infection within 90 days of admission. The proposed measure is an indicator for whether any of the eight THA/TKA complications occur.	Begins with index admission and ends 90 days post-discharge from index admission
Other	Number of THA/TKA complications	The total hip arthroplasty/total knee arthroplasty (THA/TKA) complication measure is a facility-level risk-standardized 90-day complication rate for total hip and total knee arthroplasty and is part of the targeted quality measure. However this component of the targeted quality measure is a three-year moving average. While it may not be feasible to replicate the measure, the investigators will code the underlying the eight "complications", which are heart attack, pneumonia, or sepsis/septicemia/shock within seven days of admission, surgical site bleeding, pulmonary embolism, or death within 30 days of admission, and mechanical complications or periprosthetic joint/wound infection within 90 days of admission. The proposed measure is the number of THA/TKA complications that occur.	Begins with index admission and ends 90 days post-discharge from index admission
Other	Share of LEJR admissions with an ER visit within 90-days of discharge from index admission		Begins with index admission and ends 90 days post-discharge from index admission
Other	90-day all-cause readmission		90 days post-discharge from index admission
Other	Number of covered procedures		Duration of hospital stay - average 3 days
Other	Complexity of patient mix for LEJR procedures, measured by patient demographics	The complexity of patient mix for LEJR procedures is measured by the projected episode payment using patient demographics. The investigators will generate projected episode payment based on coefficients from a regression of episode payment on patient demographics in the pre-period, controlling for MSA fixed effect. The set of patient demographics include fully interacted five-year-age-bin, race, and sex dummies, dummy for Medicaid status, and dummy for disability.	Duration of hospital stay - average 3 days
Other	Complexity of patient mix for LEJR procedures, measured by patient demographics and comorbidities	The complexity of patient mix for LEJR procedures is measured by the projected episode payment using patient characteristic, including both demographic and comorbidity measures. The investigators will generate projected episode payment based on coefficients from a regression of episode payment on patient characteristics in the pre-period, controlling for MSA fixed effect. The set of patient characteristics include fully interacted five-year-age-bin, race, and sex dummies, dummy for Medicaid status, dummy for disability, dummies for Charlson comorbidities, and dummy for major complication or comorbidity (MCC).	Duration of hospital stay - average 3 days
Other	1 year total covered Medicare payments		one year since index admission
Other	1 year mortality		one year since index admission
Other	1 year all-cause readmission		one year since index admission
Other	1 year outpatient opioid use		one year since index admission
Primary	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.	At hospital discharge up to 3 days
Secondary	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.	At hospital discharge up to 3 days
Secondary	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)	Begins with index admission and ends 90 days post-discharge from index admission
Secondary	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).	Begins with index admission and ends 90 days post-discharge from index admission
Secondary	Total covered Medicare payments for Institutional PAC during episode		Begins with index admission and ends 90 days post-discharge from index admission
Secondary	Total covered Medicare payments for any PAC during episode		Begins with index admission and ends 90 days post-discharge from index admission
Secondary	Total beneficiary payments owed out of pocket during episode		Begins with index admission and ends 90 days post-discharge from index admission