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Active, Not Recruiting

NCT Number: NCT06617533

Evaluation of the Primary Care First Model

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Sex eligibility

All sexes

Study type

Observational

Primary location

Mathematica Policy Research, Inc.

Princeton, New Jersey, 08543-2393, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Practice 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.

Beneficiary Inclusion Criteria:

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

Beneficiary 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

Treatment and study plan

PCF model

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.

Primary outcomes

  1. Acute hospitalization rate

    Time frame: 5 years

    Measured per 1,000 beneficiaries per year. Given the model payment structure rewards practices for decreasing hospitalizations, we hypothesize acute hospitalizations are the primary mechanism for reduced expenditures.

  2. Total Medicare Parts A and B expenditures

    Time frame: 5 years

    Measured in dollars per beneficiary per month. Impacts on expenditures are central to CMS's decisions to expand an Innovation Center model and used to determine model PBA payments for practices.

Secondary outcomes

  1. Medical admissions

    Time frame: 5 years

    Measured per 1,000 beneficiaries per year. Evaluations of similar primary care models (such as Comprehensive Primary Care Plus) found participating practices reduced medical admissions. We may expect to see impacts on this before impacts are evident on the broader acute hospitalization measure, which includes surgical admissions.

  2. Outpatient ED visits

    Time frame: 5 years

    Measured per 1,000 beneficiaries per year. Care delivery activities that seek to reduce acute hospitalizations may reduce ED utilization.

  3. Primary-care-substitutable ED visits

    Time frame: 5 years

    Measured per 1,000 beneficiaries per year. Care delivery activities that seek to reduce acute hospitalizations may reduce ED utilization; effects may be concentrated among primary-care-substitutable ED visits.

  4. Proportion of inpatient discharges at the practice that had a 30-day all-cause unplanned readmission

    Time frame: 5 years

    We may expect to see reductions in hospital readmissions through practices' focus on episodic care management.

  5. Proportion of inpatient discharges at the practice with unplanned 30-day acute care

    Time frame: 5 years

    We may expect to see reductions in unplanned acute care (including ED visits, observation stays, and unplanned readmissions) through practices' focus on episodic care management.

  6. Post-acute care (PAC) expenditures per PAC episode

    Time frame: 5 years

    Fewer acute hospitalizations may result in lower total PAC expenditures if savings in higher-cost institutional care (such as skilled nursing facility stays) offset potential cost increases in lower-cost home health expenditures.

  7. Inpatient expenditures

    Time frame: 5 years

    Measured in dollars per beneficiary per month. Fewer acute hospitalizations may result in lower inpatient expenditures, contributing to lower total Medicare FFS expenditures.

Sponsors and collaborators

Lead sponsor

Mathematica Policy Research, Inc.

Other

Collaborators

  • Centers for Medicare and Medicaid Services

Registry information

Acronym: PCF

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Sep 27, 2024
Registry last updated
Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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