Clinical trial NCT06617533: Evaluation of the Primary Care First Model
Official title: Evaluation of the Primary Care First Model
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: All Conditions
Keywords: Primary Care First
PCF
primary care delivery
Lead sponsor: Mathematica Policy Research, Inc.
Sponsor class: OTHER
Collaborators: name: Centers for Medicare and Medicaid Services
First posted: 2024-09-27
Enrollment: 25000000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of an intervention group comprised of Medicare fee-for-service beneficiaries assigned to PCF practices and a comparison group comprised of Medicare fee-for-service beneficiaries assigned to matched comparison practices.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acute hospitalization rate
timeFrame: 5 years
measure: Total Medicare Parts A and B expenditures
timeFrame: 5 years
Secondary outcomes:
measure: Medical admissions
timeFrame: 5 years
measure: Outpatient ED visits
timeFrame: 5 years
measure: Primary-care-substitutable ED visits
timeFrame: 5 years
measure: Proportion of inpatient discharges at the practice that had a 30-day all-cause unplanned readmission
timeFrame: 5 years
measure: Proportion of inpatient discharges at the practice with unplanned 30-day acute care
timeFrame: 5 years
measure: Post-acute care (PAC) expenditures per PAC episode
timeFrame: 5 years
measure: Inpatient expenditures
timeFrame: 5 years
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Mathematica Policy Research, Inc.
state: New Jersey
Study officials:
affiliation: Mathematica Policy Research, Inc.
name: Laura Blue, PhD
role: PRINCIPAL_INVESTIGATOR
References: