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42 CFR Part 484 · CMS Compliance Platform

Survey-ready without replacing your EHR.

Your Axxess, HHAeXchange, MatrixCare, or Alora runs the visit. FileFlo runs the evidence a state surveyor asks for: aide competency (§484.80), patient rights (§484.50), QAPI (§484.65), the comprehensive-assessment chain (§484.55), every document tagged to its 42 CFR Part 484 citation, the Conditions-of-Participation binder one click away. Not an EHR. Not a migration.

By Chad Griffith·Founder & CEO·Reviewed June 4, 2026

5-day trial · No credit card · Sits alongside your EHR · No migration

60 sec
§484 CoP survey binder
Down from days of assembly
Part 484
Every Condition of Participation
418 hospice · 483 SNF
No EHR swap
Sits alongside your EHR
Axxess · HHAeXchange · MatrixCare
5-day
Free trial
No credit card
What you get

Everything a surveyor asks for, tagged to its Condition.

Every aide current, every visit

Each aide's annual competency evaluation, in-service hours, and caregiver license / TB / health status tracked, with 90/60/30-day renewal alerts to the DON so nothing lapses before a surveyor finds it.

42 CFR §484.80

Every document tagged to its Condition

Patient rights (§484.50), care planning (§484.60), QAPI (§484.65), clinical records (§484.110): a per-patient evidence map showing what's on file and what's missing.

42 CFR PART 484 CoP MAP

The state-survey binder in 60 seconds

A surveyor-organized Conditions-of-Participation packet on demand. Sits alongside Axxess, HHAeXchange, MatrixCare, Alora, or WellSky, with no migration and no clinical-charting overlap. Hospice (Part 418) & SNF (Part 483) too.

ONE-CLICK CoP BINDER

Assessment & recert cadence, watched

Track the comprehensive-assessment and recertification cadence with alerts before the window closes, then store the locked OASIS-E PDF from your EHR as the evidence. Your EHR submits OASIS; FileFlo keeps the proof.

42 CFR §484.55
The survey scramble

One condition-level gap puts your certification at risk.

Your EHR runs the visit. But the §484 evidence a surveyor asks for is scattered across email, a shared drive, and a binder nobody's updated since the last survey.

Standard Survey

8:34 AM. A state surveyor is at the door for your recertification survey.

The risk: They want clinical records, aide competency evaluations, patient-rights acknowledgments, and signed plans of care for your active census, right now. Your charting lives in Axxess, but the §484.80 competency evals, contractor licenses, and signed POCs are scattered across email, a shared drive, and a binder nobody's touched since the last survey.

FileFlo generates the complete 42 CFR Part 484 Conditions-of-Participation binder in 60 seconds: every document tagged to its citation, every aide competency current. Hand the surveyor a clean evidence package. No condition-level deficiencies.

Aide Competency (§484.80)

An aide's annual competency evaluation lapsed three weeks ago, and she's still on the schedule.

The risk: §484.80 requires a documented competency evaluation. An aide delivering care without a current one is a condition-level finding waiting to happen, and the liability runs straight to the patient.

FileFlo sends 90/60/30-day competency and in-service alerts to the DON. You re-evaluated when the first alert fired. Nothing lapsed. Nothing to explain to the surveyor.

Assessment / Recert (§484.55)

A recertification window slipped and the comprehensive assessment is late.

The risk: §484.55 governs the timing of the comprehensive assessment and recertification. A missed window is a documentation gap the surveyor will find, and it cascades into the plan of care and the claim.

FileFlo tracks the assessment and recert cadence and alerts before the window closes, then stores the locked OASIS-E PDF from your EHR as the evidence. Your EHR submits OASIS; FileFlo keeps the proof.

Patient Rights & Records (§484.50 / §484.110)

The surveyor pulls five charts and asks for the patient-rights notice and the signed plan of care for each.

The risk: §484.50 requires a documented patient-rights notice at admission; §484.110 governs clinical-record completeness. One missing signature per chart compounds fast across a census.

FileFlo's evidence map shows, per patient, which Condition-of-Participation documents are on file and which are missing, so you close the gap before the surveyor finds it.

Survey day

Same surveyor. Two different mornings.

The difference is whether the §484 evidence is one click away.

Without FileFlo
8:34 AM

Surveyor arrives for the recert survey

Requests aide competencies, patient-rights notices, signed POCs

8:50 AM

Pulling evidence from Axxess, email, and a binder

Can't find current competency evals for 6 aides

9:40 AM

Surveyor finds a lapsed §484.80 competency

Condition-level finding: aide delivering care without a current eval

10:55 AM

8 plans of care missing a signature (§484.60)

Additional finding: care not delivered per the plan of care

11:45 AM

Survey continues with multiple deficiencies

CMS certification at risk. Corrective action plan required.

Condition-level deficiencies · corrective action plan · certification at risk

With FileFlo
8:34 AM

Surveyor arrives for the recert survey

Requests aide competencies, patient-rights notices, signed POCs

8:37 AM

Open FileFlo on your laptop

Generate the complete 42 CFR Part 484 CoP binder in 60 seconds

8:45 AM

Hand the surveyor a tagged evidence package

Every aide competency current; every POC signature accounted for

9:30 AM

Surveyor spot-checks patient-rights & clinical records

Each document tagged to its §484 citation. Nothing missing.

10:15 AM

Survey concludes with no condition-level findings

CMS certification maintained. Zero deficiencies.

Zero condition-level findings · binder produced in 60 seconds

Run a free HHA survey-readiness audit first.

Three minutes, no signup, no credit card. Walks through every CoP at 42 CFR Part 484, 418, and 483 and flags the gaps a state surveyor would write. The 5-day FileFlo trial is right there if you want it next.

Run a free survey audit
Reality check

If a state surveyor walked in right now, could you prove it?

  • Can you show a current §484.80 competency evaluation for every aide on the schedule?
  • Is there a documented patient-rights notice (§484.50) on every active admission?
  • Can you produce signed plans of care (§484.60) for your full census in under an hour?
  • Do you know which caregiver licenses or TB tests expire in the next 30 days?
  • Is the comprehensive-assessment / recert cadence (§484.55) current for every patient?
  • Do you have the QAPI documentation (§484.65) a surveyor expects to see?
  • Can you generate a §484 Conditions-of-Participation binder on demand?
  • Would your clinical records (§484.110) survive a chart-by-chart spot check?
Take the free 3-minute HHA readiness check
Built for post-acute care

Home health, hospice, and skilled nursing.

Home Health Agencies

Medicare-certified skilled nursing & therapy under 42 CFR Part 484: the §484 evidence layer alongside your EHR.

  • Medicare-certified HHAs
  • Multi-branch agencies
  • Medicaid home care

Hospice

Part 418 Conditions of Participation: IDG documentation, bereavement, and volunteer records, survey-ready.

  • Medicare hospice
  • IDG documentation
  • Bereavement & volunteer records

Skilled Nursing & Post-Acute

Part 483 requirements for long-term care: license, training, and survey evidence in one binder.

  • Skilled nursing facilities
  • Rehab & post-acute
  • Assisted living credentials
Pricing

Two tiers. No per-caregiver fees.

Starter
$89/mo

or $890/yr · annualized $74/mo

  • · 100 documents per month
  • · 3 users
  • · Solo / small agencies
Most popular
Professional
$299/mo

or $2,990/yr · annualized $249/mo

  • · Unlimited documents & users
  • · Aide auto-detection · Audit trail
  • · Multi-branch agencies

5-day free trial on both tiers. No credit card required. No per-caregiver, per-patient, or per-visit fees. Cancel anytime.

Running 10+ branches or a multi-state agency group? FileFlo Enterprise →

The technical detail · for DONs & administrators

Platform definition.

FileFlo is a compliance document intelligence platform for home health agencies, hospices, and skilled nursing facilities. It operates as a read-only layer on top of the cloud storage and EHR exports an agency already uses. It does not replace the EHR, submit OASIS, or run electronic visit verification. It classifies each document against its governing CMS Condition of Participation (42 CFR Part 484 for home health, Part 418 for hospice, Part 483 for skilled nursing), tracks aide competency and license expirations, enforces the comprehensive-assessment and recertification cadence, and generates a surveyor-organized Conditions-of-Participation binder on demand.

The distinction matters because an EHR like Axxess, Alora, MatrixCare, or HHAeXchange is optimized for charting, scheduling, and claims, not for proving, document by document, that every Condition of Participation is satisfied when a state surveyor arrives under 42 CFR Part 488. The EHR holds the clinical record; FileFlo holds the survey evidence, tagged to the exact §484 citation a surveyor cites.

Regulatory foundations

Home health, hospice & SNF compliance.

Healthcare compliance in the United States is anchored in the Code of Federal Regulations, with the heaviest documentation burden falling on home health agencies, hospices, and skilled nursing facilities. The Conditions of Participation for home health agencies are codified at 42 CFR Part 484, while skilled nursing facility requirements live at 42 CFR Part 483, and hospice Conditions of Participation are codified at 42 CFR Part 418. Each section requires written, retrievable evidence of clinician credentials, comprehensive patient assessments, plans of care, and quality-assurance records, exactly the documentation surveyors demand on entry.

Layered on top of CMS Conditions of Participation, HIPAA's Privacy and Security Rules at 45 CFR Part 164 mandate documented administrative, physical, and technical safeguards plus an auditable trail of every PHI access event. HIPAA Privacy Rule violations can reach $50,000 per violation (45 CFR §160.404, 2026 inflation-adjusted), with annual caps that scale into the millions for sustained non-compliance.

When CMS or a state survey agency arrives, the procedural framework at 42 CFR Part 488 governs the survey itself: what evidence surveyors request, how findings are documented, and how enforcement remedies (denial of payment, civil money penalties, termination) escalate. FileFlo's compliance taxonomy maps every classified document to the specific CFR section that demands it, so a surveyor asking for "the most recent comprehensive assessment under §484.55" gets an answer in seconds, not a frantic three-cabinet search.

How FileFlo compares

FileFlo vs. healthcare compliance platforms.

Capability comparison based on publicly available product documentation and vendor websites as of May 2026. FileFlo row highlighted.

Capability comparison: FileFlo vs Axxess, Alora, HHAeXchange, CareSmartz360, and AlayaCare across CMS CoP coverage, HIPAA audit trail, all-documents search, pricing, and free trial.
PlatformPrimary use caseCMS CoP §484HIPAA audit trailAll-docs searchPricing floorFree trial
AxxessEHR + agency operations for HHA/hospiceDeep (clinical workflows)Yes (EHR-level)No (clinical records only)Custom quoteDemo only
Alora HealthEHR for home health & hospiceDeep (clinical workflows)Yes (EHR-level)No (clinical records only)Custom quoteDemo only
HHAeXchangeHomecare workforce + EVV managementPartial (Medicaid focus)Yes (workforce records)No (worker records only)Custom quoteDemo only
CareSmartz360Homecare agency mgmt + schedulingLimitedPartialNoCustom quoteDemo only
AlayaCareEnd-to-end home & community care platformDeep (clinical workflows)Yes (EHR-level)No (clinical records only)Custom quoteDemo only
FileFloCFR-cited document intelligence across every healthcare doc typeFull (every §484 sub-cited)Yes (full chain-of-custody)Yes (every classified doc)$89/mo (Starter)5-day free trial
About the author

Built against the surveyor's checklist, not a generic abstraction.

Chad Griffith, Founder & CEO of FileFlo, built FileFlo's healthcare rule packs against the actual CMS Conditions of Participation and the state-survey process at 42 CFR Part 488, mapping every document to the exact §484, §418, or §483 citation a surveyor cites. That regulatory specificity is why FileFlo can sit on top of an agency's existing EHR and storage and still speak the language a state surveyor uses, with no migration and no clinical-charting overlap.

Healthcare compliance FAQs

Quick answers.

Every answer cites a specific CFR section. Last reviewed June 4, 2026.

Is FileFlo an EHR replacement for my agency?

No. FileFlo sits alongside Axxess, HHAeXchange, MatrixCare, Alora, or WellSky. Your EHR runs the visit, schedules caregivers, and submits OASIS-E; FileFlo organizes the 42 CFR Part 484 compliance evidence a surveyor asks for. No migration, no clinical-charting overlap.

Who surveys home health agencies, and against what?

State survey agencies conduct standard and complaint surveys on behalf of CMS under 42 CFR Part 488, against the Part 484 Conditions of Participation (Part 418 for hospice, Part 483 for skilled nursing). FileFlo maps every document you store to the relevant Condition of Participation.

Does FileFlo track §484.80 aide training and competency?

Yes. FileFlo tracks each aide's competency evaluation date, in-service hours, and caregiver license / TB / health status, with 90/60/30-day renewal alerts to the DON so nothing lapses before a surveyor finds it.

Does FileFlo handle OASIS or EVV?

No, and that's intentional. Your EHR submits OASIS-E; your EVV vendor (e.g. HHAeXchange) runs Medicaid electronic visit verification under §441.301. FileFlo stores the locked OASIS PDF and EVV exception reports as survey evidence; it doesn't replace either system.

What documents does the CoP binder include?

Aide competencies (§484.80), patient-rights notices (§484.50), plans of care (§484.60), comprehensive-assessment evidence (§484.55), QAPI documentation (§484.65), and clinical records (§484.110), plus contractor/vendor and license records, each tagged to its citation and produced in one click.

How long does it take to set up FileFlo for an agency?

Most agencies are running in about a day. Connect your existing folders (Google Drive, SharePoint, Dropbox), and FileFlo's AI classifies your documents against the Part 484 Conditions of Participation and flags the gaps a surveyor would cite.

How much does FileFlo cost for a home health agency?

Starter is $89/month and Professional is $299/month, both with a 5-day free trial. Preventing a single condition-level deficiency, or the corrective-action scramble that follows, pays for years of FileFlo. Flat pricing, no per-caregiver fees; see /pricing for details.

Free: 24-page CMS Survey Readiness Worksheet + F-Tag Response Templates

F-Tag-by-Tag preparation, CMS-2567 reading guide, Plan of Correction template (5 elements), Joint Commission tracer prep, HIPAA Security Risk Analysis template.

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Stay survey-ready without touching your EHR.

Your EHR runs the visit and submits OASIS. FileFlo runs the 42 CFR Part 484 evidence: every Condition of Participation tracked, the state-survey binder one click away. Start your 5-day free trial.

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