Home Health Agency Startup Checklist: Everything You Need to Get Certified
Start your Medicare-certified Home Health Agency with this complete step-by-step startup checklist covering licensing, policies, PECOS enrollment, survey readiness, and compliance.
12/3/20256 min read
Starting a Medicare-certified Home Health Agency (HHA) requires careful planning, extensive documentation, and strict compliance with federal and state regulations. Because HHAs provide skilled services directly in the patient’s home, the Centers for Medicare & Medicaid Services (CMS) requires agencies to operate under a defined set of standards called the Conditions of Participation (CoPs). These regulations determine how an agency must operate, how clinical care must be delivered, and what must be in place before certification is granted.
This comprehensive checklist outlines every step required to launch a compliant home health agency—from initial planning to passing your Medicare survey—so you can build a strong foundation for quality and long-term operational success.
1. Understand the Regulatory Framework Before You Begin
Before you invest in licensing, staffing, or office space, it is essential to understand who regulates home health.
CMS is the primary federal authority and enforces the Medicare CoPs under 42 CFR Part 484. These regulations cover key areas including patient rights, skilled nursing standards, therapy services, comprehensive assessments, care planning, QAPI, infection control, emergency preparedness, and clinical documentation requirements.
States also impose separate licensing rules that are often just as detailed. State departments—typically Departments of Public Health—set standards for background checks, business location requirements, administrator qualifications, operational expectations, and pre-survey readiness. While CMS oversees certification, states oversee enforcement and play a critical role in determining whether your agency can progress toward Medicare enrollment.
Understanding these layers of regulation is the foundation of a successful startup.
2. Establish the Legal Structure of Your Agency
The first operational step in creating a home health agency is establishing your legal business structure.
Most agencies choose business entities such as an LLC, S-Corporation, or C-Corporation. Once the entity type is chosen, you must file Articles of Organization or Incorporation with your state and obtain an Employer Identification Number (EIN). In addition, your home health agency must secure a local business license if required by your city or county.
CMS and state regulators also require that your agency establish a governing body responsible for oversight. This governing body must appoint an Administrator to oversee daily operations and a Director of Patient Care Services (DPCS)—or Clinical Director—who must be a qualified registered nurse meeting state-specific experience requirements. Both roles must be full-time and available during business hours.
Your governing body must meet before licensure to approve policies, designate leadership, and establish authority, and these minutes will be required during survey.
3. Develop Policies, Procedures, and Compliance Infrastructure
Your agency must create a complete, CMS-compliant policy and procedure manual before you can obtain state licensing or undergo a certification survey. Surveyors will review these policies to verify that your operations align with the CoPs.
Your manual must address:
Clinical Practice Standards
Policies must outline roles and responsibilities for skilled nursing, therapy services (PT, OT, ST), medical social work, and home health aide services. Policies must reflect scope-of-practice standards and supervision requirements.
Patient Rights and Complaint Policies
CMS requires agencies to outline patient rights such as freedom from discrimination, participation in care planning, privacy, and the right to file complaints. These rights must appear in your admission packets and be posted in the office.
QAPI Program (Quality Assessment and Performance Improvement)
CMS mandates a formal, ongoing quality improvement program that uses data to identify performance gaps and implement corrective action. Your QAPI plan must include quarterly meetings, performance indicators, and documentation of improvement activities.
Infection Prevention and Control Program
Your infection control program must include surveillance, standard precautions, transmission-based precautions, reporting procedures, and annual staff training. This program must be active before survey.
Emergency Preparedness Program
Under §484.102, your agency must conduct a risk assessment, develop an emergency plan, create a communication plan, and complete annual training and testing exercises. Surveyors will request proof of drills.
Human Resources and Staffing Compliance
Policies must include background check requirements, tuberculosis screening, competency assessments, orientation requirements, and ongoing education plans.
These documents must be complete and ready for review when your survey is scheduled.
4. Obtain State Home Health Agency Licensing
Most states require you to obtain a home health license before applying to Medicare. Licensing applications generally include:
Ownership disclosures
Administrator and DPCS qualifications
Policies and procedures
Lease agreements or office documentation
Governing body bylaws and minutes
Fingerprinting and background checks
Proof of financial stability
Organizational chart
Some states also require a pre-licensure inspection to confirm operational readiness. Licensing timelines vary significantly: some states approve within 30–60 days, while others may take 6–12 months.
Licensure must be obtained before your agency can request a Medicare survey.
5. Set Up a Compliant Office Location
A fully operational office is required before the state or CMS will conduct any survey. Surveyors will physically visit your office to confirm compliance.
Your office must include:
Locked storage for clinical records
HIPAA-secure workstations
A working business phone line and fax
Required labor law and patient rights posters
Emergency preparedness plan displayed
Policy manual accessible onsite
Personnel files maintained and locked
Adequate workspace for administrative staff
You must also maintain office hours consistent with state requirements, usually Monday through Friday, during business hours.
Surveyors expect a functioning environment—not an empty or staged office.
6. Obtain Your National Provider Identifier (NPI)
Your NPI is required for Medicare enrollment and identifies your agency for billing and administrative purposes. The NPI must match the legal business name and taxonomy for home health services.
7. Complete the CMS PECOS Enrollment (Form 855A)
To participate in the Medicare program, your agency must submit a full Medicare enrollment application through PECOS (Provider Enrollment, Chain, and Ownership System). This step is highly detailed and includes federal background screening and site validation.
The PECOS enrollment includes:
CMS-855A Medicare application
CMS-460 Participating Provider Agreement
CMS-1561 Certification Statement
Ownership and managing control disclosures
Legal structure verification
NPI verification
State licensing documentation
Governing body details
Lease agreement and site control documentation
A federal contractor will conduct an unannounced site visit during this phase to verify your office location and operations.
8. Prepare for Your Medicare Certification Survey
Once PECOS approves your application and your state allows you to move forward, the CMS survey agency will schedule an initial certification survey. This process is extensive, and preparation is critical.
Surveyors will evaluate:
Clinical Documentation
This includes OASIS assessments, skilled nursing documentation, therapy evaluations, medication profiles, plans of care, visit notes, discharge documentation, and coordination with physicians. Charts must demonstrate accuracy, timeliness, and compliance with the CoPs.
Personnel Requirements
Surveyors will review personnel files for background checks, licensure, competency evaluations, orientation records, and RN supervisory documentation.
Operational Readiness
Your QAPI plan must demonstrate active data monitoring. Your emergency preparedness program must show evidence of drills. Your infection control program must show surveillance data and staff training.
Your initial patients will be reviewed during survey. Agencies must have admitted active patients with completed assessments and skilled services before the survey date.
9. Admit Your First Patients Before Survey
CMS requires agencies to admit and care for patients under their state license before survey. You must demonstrate the delivery of legitimate skilled services, including comprehensive assessments, care planning, and visit documentation. This ensures surveyors can evaluate real patient records rather than hypothetical or staged documentation.
The agency must show active clinical operations—not preparation—at the time of survey.
10. Complete the Initial Certification Survey and Correct Deficiencies
During the survey, CMS surveyors will identify any deficiencies. These may be standard-level or condition-level deficiencies.
Standard-level deficiencies require corrective actions and submission of a Plan of Correction (POC). Condition-level deficiencies are more serious and may require resurvey. Your POC must outline corrective action, systemic prevention, staff training, and monitoring methods.
Once the state agency approves your POC, certification can move forward.
11. Receive Medicare Certification and Begin Billing
After CMS approves your survey and POC, your agency will receive:
A CMS Certification Number (CCN)
An approval letter
A Medicare effective date
At this point, your agency may begin billing Medicare, apply for Medicaid enrollment, and contract with managed care organizations. You can also begin establishing referral pipelines and expanding your operational capacity.
12. Maintain Ongoing Medicare Compliance
Certification is not the end—it is the beginning of continuous oversight.
To maintain compliance and remain survey-ready, an agency must:
Conduct quarterly QAPI meetings
Submit accurate OASIS data
Update policies annually
Maintain active emergency preparedness drills
Provide ongoing staff education
Monitor clinical documentation
Maintain HIPAA protections
Conduct annual program evaluations
CMS can conduct complaint investigations or recertification surveys at any time. Strong internal controls protect your agency from deficiencies, payment suspension, or termination.
Conclusion
Launching a Medicare-certified home health agency requires meticulous attention to regulatory requirements, documentation standards, policy development, and operational readiness. A strong foundation ensures smooth licensing, efficient certification, and long-term success in a competitive industry.
For agencies seeking expert support, SummitRidge Consulting provides comprehensive startup solutions including policy development, Medicare 855A applications, QAPI creation, clinical compliance, operational systems, mock surveys, and certification readiness.
References & Links
(These are provided exactly as URLs per your request.)
CMS Home Health Conditions of Participation (42 CFR 484):
https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-484CMS State Operations Manual, Appendix B – Home Health Agencies:
https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/som107ap_b_hha.pdfPECOS Enrollment:
https://pecos.cms.hhs.govNPI Registration – NPPES:
https://nppes.cms.hhs.govMedicare Enrollment Forms (CMS-855A):
https://www.cms.gov/medicare/cms-forms/cms-forms/downloads/cms855a.pdf
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