Evaluation of the Primary Care First Model

NCT ID: NCT06617533

Last Updated: 2024-09-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 25000000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2026-12-31

Brief Summary

The Primary Care First (PCF) Model, sponsored by the Center for Medicare & Medicaid Innovation (Innovation Center) of the Centers for Medicare & Medicaid Services (CMS), is a multipayer advanced primary care model that aims to strengthen primary care by transforming how primary care practices deliver care. The PCF evaluation will assess how the PCF Model was implemented; how practices transformed care; and the effects on health care cost, service use, quality of care, and the experiences of patients, primary care practitioners, and staff. The evaluation will also identify facilitators and barriers to implementation and improved outcomes.

Detailed Description

The Innovation Center launched the PCF Model in 2021. The PCF Model will test whether financial risk and performance-based payments for outcomes, including the acute hospitalization rate, will (1) reduce total Medicare fee-for-service (FFS) expenditures, (2) reduce use of health care services, and (3) preserve or enhance quality of care. The PCF Model will provide payments to participating practices through (i) a per beneficiary per month (PBPM) prospective payment and (2) a Flat Visit Fee, subject to a geographic adjustment factor. PCF practices may further be eligible for a quarterly Performance-based Adjustment (PBA) based on meeting certain performance and quality benchmarks.

The PCF Model builds on principles and experiences from past Innovation Center initiatives, including the Comprehensive Primary Care Initiative, Multi-Payer Advanced Primary Care Practice (MAPCP) demonstration, and Comprehensive Primary Care Plus (CPC+). CMS enrolled practices in the PCF Model in one of two cohorts. Cohort 1 practices participate from January 1, 2021, through December 31, 2025. Cohort 2 practices participate from January 1, 2022, through December 31, 2026. Cohort 2 includes many practices that participated in CPC+. CMS defines a primary care practice under the PCF Model as one or more primary care providers (physician, nurse practitioner, physician's assistant, or clinical nurse specialist) working within the same physical office location or practice site.

The primary goal of the evaluation is to determine whether the PCF Model preserves or enhances quality of care for Medicare FFS beneficiaries and lower expenditures for CMS. The general study design will compare beneficiaries in PCF practices with beneficiaries that receive care at matched comparison practices that aren't participating in PCF but are located in PCF regions. The study will rely on three types of data sources: (1) Medicare FFS claims and enrollment data, (2) payment data for the PCF Model and other CMS programs, and (3) area-level data sets with information on beneficiary and practice characteristics.. Using these data sources, investigators also plan to evaluate the impact of the model on health care service use and a set of secondary outcomes.

Conditions

All Conditions

Keywords

Primary Care First; PCF; primary care delivery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Experimental: PCF practices

This is the intervention group, and includes the practices that were selected and agreed to participate in the PCF model.

PCF model

Intervention Type: OTHER

PCF practices practices receive (1) a per-beneficiary-per-month prospective payment that depends on the average health of their attributed Medicare beneficiaries; (2) a Flat Visit Fee for primary care visits, subject to a geographic adjustment factor, and (3) a Performance-based Adjustment (PBA). The PBAs depend on practices' performance on several quality measures in addition to their performance in reducing beneficiaries' use of inpatient care or total cost of care, relative to national and regional benchmarks. Practices must meet a limited set of care delivery requirements and can use the PCF Model's flexible use of payments to invest in strategies that best suit their practices' unique patient population and resources. In return, practices take on limited financial risk in exchange for performance-based payments that reward participants that meet certain performance and quality benchmarks for selected outcomes.

No Intervention: Comparison practices

Comparison practices are the control group. This group includes practices not participating in the model that were matched to the PCF practices and whose outcomes will be compared to those of the PCF practices.

No interventions assigned to this group

Interventions

PCF model

PCF practices practices receive (1) a per-beneficiary-per-month prospective payment that depends on the average health of their attributed Medicare beneficiaries; (2) a Flat Visit Fee for primary care visits, subject to a geographic adjustment factor, and (3) a Performance-based Adjustment (PBA). The PBAs depend on practices' performance on several quality measures in addition to their performance in reducing beneficiaries' use of inpatient care or total cost of care, relative to national and regional benchmarks. Practices must meet a limited set of care delivery requirements and can use the PCF Model's flexible use of payments to invest in strategies that best suit their practices' unique patient population and resources. In return, practices take on limited financial risk in exchange for performance-based payments that reward participants that meet certain performance and quality benchmarks for selected outcomes.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Are ready to deliver advanced primary care (as measured by questions on the PCF application) when the model launches.
• Located in 1 of 26 PCF regions
• Have at least 125 attributed Medicare FFS beneficiaries
• Have primary care services comprise at least 50 percent of billing, based on revenue, at model launch.
• Start the model using 2015 certified electronic health record technology, enabling exchange of health information with other providers and systems and connection to regional health information exchange.

• Be enrolled in both Medicare Parts A and B
• Have Medicare as their primary payer.

Exclusion Criteria

• Have end stage renal disease
• Currently enrolled in hospice care
• Covered under a Medicare Advantage or other Medicare health plan
• Currently long-term institutionalized
• Currently incarcerated

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centers for Medicare and Medicaid Services

FED

Sponsor Role: collaborator

Mathematica Policy Research, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura Blue, PhD

Role: PRINCIPAL_INVESTIGATOR

Mathematica Policy Research, Inc.

Locations

Mathematica Policy Research, Inc.

Princeton, New Jersey, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

MPR50886

Identifier Type: -

Identifier Source: org_study_id