Alignment
Beneficiary Alignment Methodology
LEAD uses a prospective alignment methodology combining claims-based alignment and voluntary alignment. Beneficiaries are aligned to an ACO before the start of each performance year (or, under Hybrid Alignment, on a rolling basis during the year). ACOs are then accountable for total Medicare Parts A and B spending for their aligned population. (RFA §VII.B)
Claims-Based Alignment (RFA §VII.B.1)
Claims-based alignment assigns beneficiaries based on a plurality-of-care methodology using Primary Care Qualified Evaluation and Management (PQEM) services. The algorithm operates in two stages:
Stage 1: Primary Care Specialist: If 10% or more of a beneficiary’s PQEM allowable charges during the lookback period were billed by primary care specialties, alignment is based solely on these providers. Primary care specialties include: family medicine (08), internal medicine (11), geriatric medicine (38), general practice (01), and nurse practitioner (50). (RFA §VII.B.1)
Stage 2: Non-Primary Care Specialist: If less than 10% of charges were billed by primary care specialties, alignment considers selected non-primary care providers that manage chronic or complex conditions. (RFA §VII.B.1)
New in LEAD: Four new specialty codes are added to Stage 2: gastroenterology (10), hospice and palliative care (17), infectious disease (44), and rheumatology (66). These join the existing list of 19 specialties including cardiology, nephrology, endocrinology, psychiatry, and others. (RFA Appendix C, Table C1)
Plurality determination: The beneficiary is aligned to the ACO whose Participant TIN furnished the largest share of PQEM allowable charges. This is a change from ACO REACH, where plurality was determined at the individual provider level. For FQHCs and RHCs, all services are treated as primary care for alignment purposes. (RFA §VII.B.1)
Lookback Period (RFA §VII.B.1)
| Alignment Type | Lookback Period | Example for PY 2027 |
|---|---|---|
| LEAD Prospective | 12 months ending 3 months before PY start | Oct 1, 2025 – Sep 30, 2026 |
| LEAD Hybrid | 12 months ending 1 day before PY start | Jan 1, 2026 – Dec 31, 2026 |
| ACO REACH | 24 months (two 12-month “alignment years”) ending 6 months before PY start | Jul 1, 2023 – Jun 30, 2025 (for PY 2026) |
| MSSP | 2 months ending Sep 30, plus 24-month expanded window for Step 3 | Oct 1, 2023 – Sep 30, 2024 (for PY 2025; primary window) |
Key Insight: LEAD compresses the lookback from ACO REACH’s 24 months to 12 months. This means alignment is more responsive to recent care patterns but less forgiving of gaps in utilization. A beneficiary who saw their PCP 20 months ago would still be aligned under REACH but would NOT be aligned under LEAD’s standard prospective option. The Hybrid option partially mitigates this by capturing 3 additional months of data.
PQEM Service Codes (RFA Appendix C, Table C3)
LEAD substantially expands the PQEM code list used for alignment. Key additions beyond what was used in ACO REACH include:
- Remote Physiologic Monitoring (99457–99458)
- Principal Illness Navigation (G0023–G0024)
- Advanced Primary Care Management (G0556–G0558)
- Community Health Integration (G0019, G0022)
- Caregiver Training codes (96202–96203, 97550–97552, G0539–G0543)
- ASCVD Risk Management (G0537–G0538)
- Safety Planning (G0560)
- Complex E/M Add-on (G2211)
- Behavioral Health Integration add-ons (GPCM1–GPCM3)
Voluntary Alignment (RFA §VII.B.2)
LEAD supports two voluntary alignment channels:
- EVA (Electronic Voluntary Alignment): Beneficiaries designate a primary clinician through Medicare.gov.
- SVA (Signature-Based Voluntary Alignment): Beneficiaries complete a paper or electronic form designating a Participant TIN as their main doctor, main provider, or main place of care. SVA is optional; ACOs must elect to participate.
New in LEAD: Beneficiaries may designate a Participant TIN (practice site) rather than just an individual clinician. This simplifies the process for multi-provider practices. LEAD also supports voluntary alignment for home-based primary care practices. (RFA §VII.B.2) For example, a beneficiary who last saw their PCP 20 months ago may still align where voluntary designation applies, even when claims-based alignment under LEAD’s shorter lookback would not attach them on claims alone.
Attestation validity: Designations are valid if made within 2 calendar years prior to the performance year start, or if the designated Participant TIN submitted a PQEM claim for the beneficiary within the last 2 years. (RFA §VII.B.2)
Carryover from ACO REACH: CMS intends to carry forward valid SVA attestations from ACO REACH when the same provider participates through the same ACO entity in LEAD. Beneficiaries must be notified with opt-out instructions. (RFA §VII.B.2)
Covered services check: At Final Settlement, CMS removes beneficiaries who were aligned via voluntary alignment only and received no claim (excluding labs and imaging) from a Participant TIN or Preferred Provider during the PY, if the beneficiary had at least one PQEM claim with a non-ACO provider in the ACO’s service area. (RFA §VII.B.2)
Key Insight: VA + Claims to the Same ACO
If a beneficiary qualifies for both voluntary alignment (VA) and claims-based alignment (CA) to the same ACO, the beneficiary is treated as claims-aligned for benchmarking purposes. This matters because claims-aligned and voluntarily-aligned beneficiaries may have different benchmark calculations. The VA designation still takes precedence for assignment, but the benchmark treatment follows claims-based methodology. (RFA §VII.B.2)
Alignment Frequency Options (RFA §VII.B.3)
| Feature | Prospective Alignment | Hybrid Alignment |
|---|---|---|
| Claims-based alignment | Once, before PY start | Once before PY start + one mid-year refresh for new TINs |
| Voluntary alignment additions | Once, before PY start | Monthly throughout the PY |
| Mid-year claims refresh | No | Yes (uses same lookback as beginning-of-year, not current-year claims) |
| Drops due to loss of eligibility | Beneficiaries who die, leave Medicare, or otherwise lose eligibility are removed per CMS methodology (timing specified in LEAD guidance). | Same; alignment lists are updated as eligibility changes. |
| Best for | Stable ACOs with established TIN lists | Growing ACOs onboarding new practices mid-year |
Key Insight: The progression across programs: MSSP (annual only) → ACO REACH Prospective Plus (quarterly VA additions) → LEAD Hybrid (monthly VA + mid-year claims refresh). LEAD’s Hybrid option provides substantially more population management flexibility than any predecessor.
Minimum Beneficiary Thresholds (RFA §VII.B.5)
| ACO Type | Year 1 | Year 2 | Year 3 | Year 4 | Year 5+ |
|---|---|---|---|---|---|
| Standard | 5,000 | 5,000 | 5,000 | 5,000 | 5,000 |
| Newly Entering | 1,000 | 2,000 | 3,000 | 4,000 | 5,000 |
| High Needs (≥40%) | 800 | 1,000 | 1,200 | 1,400 | 1,600 |
Standard ACOs must also have at least 3,000 claims-based aligned beneficiaries in at least one base year. ACOs that fall within 10% below minimums receive a two-time buffer before facing termination.
Frequently Asked Questions
Under Prospective Alignment, the aligned population is fixed at the start of the year. Under Hybrid, new voluntary alignment designations can be added monthly, but claims-based alignment is only refreshed once at mid-year (and only for new TINs).
Yes. If a beneficiary is both claims-aligned and voluntarily aligned to the same ACO, voluntary alignment takes precedence for assignment. However, for benchmark calculation purposes, a beneficiary who qualifies for both to that same ACO is treated as claims-aligned. (RFA §VII.B.2)
No. CMS uses a hierarchical alignment process to prevent dual alignment. MSSP prospective alignment takes precedence over LEAD for beneficiary alignment. (RFA §VII.B.4)
