Pennsylvania 28 Pa. Code Chapter 601: A Section-by-Section Application Package Guide
If you are starting a home health care agency in Pennsylvania, 28 Pa. Code Chapter 601 is the document your Department of Health reviewer is reading line-by-line against your submission. This guide walks Subparts A through G in the order a reviewer encounters them, names the documents each section forces you to produce, and shows where Pennsylvania applicants most often get sent back with a deficiency letter.
Most founders treat the Pennsylvania home health licensure application as a packet to fill out. The Division of Home Health treats it as evidence that you already understand 28 Pa. Code Chapter 601 — every page of the application maps to a specific Subpart of the regulation, and every missing exhibit becomes a line in the deficiency letter that delays your approval by 60 to 90 days. The Department reviews applications for "substantial compliance with the regulations at 28 Pa. Code Chapter 601, Subpart F" before issuing any license, which means you cannot admit a single patient until the reviewer can match every required document to a section of the chapter.
This article is the section-by-section companion to that review. It is written for the founder, administrator, or compliance lead who is assembling the initial packet — not the operator who already holds a license. It assumes you have read the parent Pennsylvania home health care state guide and now need the regulatory detail behind the licensing paragraph. For the broader process of forming your entity, capitalizing the business, and choosing a service model, start with our guide to starting a home health agency; and for the day-by-day operational build between license issuance and the Medicare initial certification survey, see our First 90 Days operational playbook.
How the PA Division of Home Health Reviews Applications
Pennsylvania's home health licensure program sits inside the Department of Health, Bureau of Facility Licensure and Certification, Division of Home Health, at 2525 N. 7th Street, Harrisburg, PA 17110. Initial applications are submitted by email to [email protected], with the $250 fee mailed separately to the Division at the Harrisburg address. Hand delivery is not accepted, and the application packet currently in use was revised on February 4, 2025 — applicants using earlier revisions are routinely returned without review.
The review itself is iterative rather than pass/fail. Pennsylvania does not run a pre-survey workshop the way Texas does for HCSSA applicants; instead, a licensure analyst reads your submission against Chapter 601, identifies every gap, and issues a deficiency letter listing what is missing or non-conforming. You respond, the analyst re-reviews, and the cycle continues until the file is clean enough to schedule the initial unannounced state survey. In our experience working with Pennsylvania applicants, two deficiency cycles is typical and three is not unusual, which is why the practical timeline from submission to first patient is often 60 to 90 days longer than founders plan for.
Two implications of this process shape how you should build the package. First, every document needs an obvious tag back to the section it satisfies — reviewers should not have to guess which exhibit answers § 601.31 versus § 601.32. Second, the cost of a thin first submission is not rejection, it is the calendar. A packet that draws a four-line deficiency letter approves three months sooner than one that draws a four-page letter, and three months of payroll for an administrator and director of nursing you have already hired is real money. Treat the first submission like the last one.
Subpart A — General Provisions (§§ 601.1, 601.2, 601.3)
Subpart A is short, but it controls what you are applying for. § 601.1 (Citation) and § 601.3 (Functional purpose) establish that Chapter 601 governs home health care agencies — organizations staffed and equipped to provide skilled nursing care plus at least one other therapeutic service (home health aide, physical therapy, speech therapy, occupational therapy, or medical social services) to patients on a part-time or intermittent basis in their place of residence. § 601.2 (Definitions) supplies the working vocabulary for the rest of the chapter, including the terms "agency," "home health aide," "skilled nursing care," and "plan of treatment" that recur throughout Subparts C through G.
The application package decision driven by Subpart A is whether you are filing under Chapter 601 at all. Pennsylvania separates medical home health (Chapter 601) from non-medical home care (Chapter 611). If your business model is companionship, bathing, dressing, meal preparation, and other personal-care services without skilled nursing, you do not file a Chapter 601 application — you file under Chapter 611 with a different fee schedule, different competency rules, and a different consumer-protection regime. Many founders choose to operate both lines of business eventually, but you license them separately and the application packets do not overlap. For the Chapter 611 walkthrough — home care agencies versus home care registries, the $100 fee, § 611.55 competency pathways, and the consumer disclosures required under § 611.57 — see our sister article on 28 Pa. Code Chapter 611. If you are unsure which side you fall on, the test in § 601.3 is whether you intend to provide skilled nursing care plus at least one of the qualifying therapeutic services; if yes, you are in Chapter 601 territory and the rest of this guide applies. The federal-level disambiguation between skilled home health and non-medical home care — scope of practice, licensure stacks, payer access, and caregiver qualifications across all 50 states — is in our skilled vs non-medical regulatory differences walkthrough.
Subpart B — Licensure (§§ 601.11–601.18)
Subpart B is the application itself — application form, term, fees, renewal, transfer, and the consequences of operating outside the license. This is the part of the regulation most directly mirrored in the PA DOH application document, and it is where the majority of first-pass deficiencies originate.
§ 601.11 (Application for licensure). The application form requires the legal name of the applicant entity, every fictitious or "doing business as" name the agency will use, the physical service address, the parent organization if any, the names and home addresses of every owner with at least a 5% interest, the administrator, and the supervising physician or registered nurse. Applicants frequently understate ownership disclosures by listing only the operating LLC and omitting upstream holding companies — Pennsylvania expects the full organizational chart, and a thin disclosure here is one of the most common deficiency-letter triggers.
§ 601.12 (Term of license). Initial licenses are issued for a fixed term and must be renewed before expiration. Pennsylvania does not pro-rate the initial fee for partial terms, and the license is non-transferable in any way that is not affirmatively authorized by the Department. Plan your business launch around the renewal calendar from day one.
§ 601.13 (Regular license) and § 601.14 (Provisional license). A regular license is issued when the agency demonstrates substantial compliance with all applicable provisions of Chapter 601. A provisional license is issued when the agency is operating but has not yet achieved full compliance — typically because a finite, correctable deficiency was identified during a survey. Provisional licenses come with shorter terms, follow-up surveys, and explicit corrective-action obligations. Most new agencies aim for, and receive, a regular license at initial licensure; the provisional pathway is more common for operators correcting findings from a survey of an existing license.
§ 601.15 (Notification of changes). Once licensed, the agency must notify the Department of any change in ownership, administrator, supervising physician or registered nurse, services offered, or service address — generally in advance and in writing. The application package itself should include the policy that operationalizes this, because reviewers regularly ask "show me how you will tell us when your administrator changes."
§ 601.16 (Renewal of licenses). Renewals require the same fee and substantially the same documentation as the initial application, plus evidence of continuous compliance during the term. New agencies should build their document-retention practices around the assumption that a renewal reviewer will want the same exhibits the initial reviewer received, updated.
§ 601.17 (Revocation, refusal, or nonrenewal). The Department may revoke, refuse to issue, or refuse to renew a license for failure to comply with Chapter 601, the underlying Health Care Facilities Act, or any other applicable Commonwealth law. Revocation actions are appealable through formal administrative processes, but the operational impact is immediate.
§ 601.18 (Penalties). Civil penalties under the Health Care Facilities Act may be imposed for operating without a license, operating outside the scope of an issued license, or continuing to violate Chapter 601 after notice. The penalty exposure is the reason the application document is explicit that "agencies cannot admit or treat any patients until approval is received from the Department of Health."
Subpart C — Acceptance of Patients, Plan of Treatment, Medical Supervision (§ 601.21 and related)
Subpart C is where the regulation moves from "who you are" to "how you treat patients." For application purposes, this Subpart drives the policies and procedures around patient acceptance, the physician's plan of treatment, and ongoing medical supervision. § 601.21 (commonly cited under the Personnel and patient-acceptance heading in Pennsylvania practice) sets the substantive standards.
Three artifacts in your application package satisfy Subpart C. First, an Acceptance of Patients policy that defines the criteria the agency uses to accept a referral — diagnosis appropriateness, geographic service area, ability to safely deliver the ordered services in the home environment, and any payor-specific requirements. Second, a Plan of Treatment policy and template showing how the physician's orders are documented, signed, dated, reviewed at least every 60 days, and updated when the patient's condition changes. Third, a Medical Supervision policy describing how the supervising physician or registered nurse oversees the clinical program, signs off on plan-of-treatment changes, and is available for clinical questions during business hours and on call after hours.
Reviewers test these by sampling. They will read your Acceptance of Patients policy, then look at the patient referral form your intake staff would actually fill out, and check that the form captures every element your policy says it captures. If your policy says intake screens for environmental safety hazards and your intake form has no field for environmental safety, that is a deficiency. Build the policy and the operational form together.
Subpart D — Group of Professional Personnel (§ 601.31)
§ 601.31 (Group of professional personnel) requires every Chapter 601 agency to have a group of professional personnel — at minimum, the supervising physician or registered nurse plus at least one other professional from an allied therapy or social work discipline — that establishes and annually reviews the agency's policies governing the scope of services, admission and discharge criteria, medical supervision and plans of treatment, emergency care, clinical records, personnel qualifications, and the program evaluation process.
The application artifact for § 601.31 is a Group of Professional Personnel charter: the names and credentials of each member, their disciplines, the meeting cadence (at least annual is required; quarterly is more defensible), the topics they will review, and a sample meeting agenda. Reviewers want to see that the group is real and constituted before licensure, not aspirational. New agencies sometimes try to satisfy this with a single physician medical director and the administrator wearing two hats — that does not meet § 601.31 because the administrator is not by definition a member of an allied health profession. Build the group with at least three appropriately credentialed members, and document it.
The minutes of the first organizational meeting of the group should be in the application package. The minutes should show the group adopting the agency's policies and procedures manual by reference and scheduling the next review. A reviewer reading those minutes alongside your P&P manual gets immediate evidence that § 601.31 is operational, not theoretical.
Subpart E — Administrative and Supervisory Function (§§ 601.32, 601.33)
Subpart E names two specific roles the agency must staff. § 601.32 (Administrator) requires a qualified administrator who is responsible for the overall management of the agency, who organizes and directs the agency's ongoing functions, who maintains ongoing liaison among the governing body, the group of professional personnel, and the staff, and who employs qualified personnel. § 601.33 (Supervising physician or registered nurse) requires a designated clinician who is responsible for the supervision of services and who is on the agency's staff or available through arrangement.
Application package documentation for these two roles is heavier than founders typically expect. For the administrator, you need a position description that mirrors § 601.32, a résumé or CV, evidence of any required prior experience, and an organizational chart that shows the administrator's reporting line up to the governing body and down to the supervising clinician and operations staff. For the supervising physician or registered nurse, you need the same — position description tied to § 601.33, current Pennsylvania license verification, CV or résumé, and a written agreement (employment or contract) confirming the relationship and on-call availability.
One specific deficiency to avoid: the administrator and the supervising registered nurse can be the same person only if that person is appropriately credentialed for both roles and the position descriptions and time allocations make clear how the two responsibilities are discharged without conflict. Pennsylvania reviewers scrutinize dual-role designations more than single-role ones, so if you are running lean at startup, expect more documentation pressure, not less.
Subpart F — Patient Care Services
Subpart F is the longest Subpart and the one the application document explicitly cites: the Department reviews for "substantial compliance with the regulations at 28 Pa. Code Chapter 601, Subpart F." This Subpart sets the standards for the actual care services your agency delivers — skilled nursing, physical therapy, speech therapy, occupational therapy, medical social services, and home health aide services — along with the coordination, supervision, and clinical-record practices that surround them.
Skilled nursing services. Skilled nursing must be furnished by or under the supervision of a registered nurse, in accordance with the plan of treatment, and within the scope of the Pennsylvania Nurse Practice Act. The application package needs a skilled-nursing policy describing initial assessment, ongoing assessment, documentation requirements, and the protocols for nursing tasks the agency is licensed to perform.
Therapy services. Physical therapy, occupational therapy, and speech-language pathology services must be provided by therapists who hold current Pennsylvania licenses in their respective disciplines. If the agency is contracting these services rather than employing therapists directly, the application must include the contractor agreements and evidence of the contractors' licensure.
Medical social services. If the agency offers medical social services as its qualifying second therapeutic service under § 601.3, those services must be furnished by a qualified medical social worker. The credentialing standard, scope of services, and supervisory relationship all need to be documented.
Home health aide services. The HHA service line is the most common stumbling block in the application, because it brings federal training requirements into the state package. The agency must use only home health aides who have completed at least 75 hours of training including 16 hours of supervised practical training, who have passed a competency evaluation, and who appear on the Pennsylvania Nurse Aide Registry. The application document specifically requires "a copy of the home health aide training program with clearly defined topics and hours per topic" and "documentation that criminal background checks have been completed for all employees." If you are going to use a third-party training program, include the program description, the topic-hours breakdown, and evidence that the program is approved.
Coordination and supervision. Subpart F also requires that all services furnished under the plan of treatment be coordinated, that the supervising clinician make periodic supervisory visits, and that the patient's primary nurse or therapist communicate regularly with the rest of the care team. The application policy on care coordination is short but unavoidable.
For each service line you intend to offer at licensure, the application package needs (1) the policy and procedure governing that service, (2) the staffing model, (3) the credentialing standard for the personnel who will deliver it, and (4) sample documentation showing how the service will appear in the clinical record. Service lines you do not intend to offer at initial licensure are easier to add by amendment later than to defend with thin documentation now.
Subpart G — Clinical Records (§§ 601.51–601.53)
Subpart G governs the clinical record system. § 601.51 establishes that the agency must maintain a clinical record for every patient that includes pertinent identifying information, the name of the physician, the drugs, dietary, treatment and activity orders, signed and dated clinical and progress notes, copies of summary reports sent to the physician, and a discharge summary. § 601.52 sets retention requirements (typically a minimum of five years following discharge, longer for minors). § 601.53 addresses confidentiality and the conditions under which records may be disclosed.
Three documents in the application satisfy Subpart G. First, a Clinical Records policy that names the elements required by § 601.51 and describes how each is captured in your EMR or paper system. Second, a Records Retention policy that meets or exceeds the minimum retention period and addresses storage media, off-site storage if any, and destruction practices. Third, a Confidentiality and HIPAA policy that maps state confidentiality requirements onto the federal HIPAA Privacy Rule — Pennsylvania does not require HIPAA compliance through Chapter 601 itself, but a reviewer will expect your record-handling policies to be consistent with HIPAA because your clinical staff will be HIPAA-covered through their professional roles regardless.
A practical tip: Pennsylvania reviewers regularly ask for sample chart structures during the licensure review, even though no live patients exist yet. Having a blank, fully-formatted sample chart — admission packet, plan of treatment, sample progress note, sample physician communication, sample discharge summary — avoids the deficiency note that says "policy describes elements but no sample format is provided."
The Pennsylvania Application Package: Line-by-Line Checklist
The PA DOH initial application document, in its February 4, 2025 revision, expects the following exhibits to accompany the completed application form. Use this as your packet outline.
- Completed application form (current revision dated February 4, 2025 or later) — applicant entity, ownership disclosure, administrator, supervising clinician, services to be offered, service address.
- $250 license fee by check or money order payable to "Commonwealth of Pennsylvania," mailed separately to the Division of Home Health at 2525 N. 7th Street, Harrisburg, PA 17110.
- Evidence of business entity formation — Pennsylvania Department of State filing, EIN, fictitious-name registrations if any.
- Organizational chart showing governing body, administrator, supervising clinician, group of professional personnel, and operational staff.
- Administrator package — § 601.32 position description, CV/résumé, prior experience documentation.
- Supervising physician or registered nurse package — § 601.33 position description, CV, current Pennsylvania license verification, written agreement.
- Group of Professional Personnel charter — names, credentials, meeting cadence, sample agenda, organizational meeting minutes.
- Policies and Procedures manual covering Subparts C through G, with each policy tagged to the section it satisfies.
- Home health aide training program description with clearly defined topics and hours per topic, totaling at least 75 hours including 16 hours of supervised practical training.
- Criminal background check protocol — the Pennsylvania State Police SP-4-164 form for new hires, the Childline child abuse history clearance, and the FBI fingerprint check for non-resident hires under Act 153, with documentation that all three clearances have been completed for every covered employee. The full federal-plus-state stack, including the OIG LEIE and SAM.gov monthly checks layered above the Pennsylvania three-clearance process, is walked in our background check compliance reference.
- Sample clinical record — admission packet, plan of treatment, progress note, physician communication, discharge summary.
- Service-line policies for skilled nursing, therapy, medical social services, and HHA services as applicable to the services you are requesting at licensure.
- Emergency preparedness policy consistent with the Department's expectations and the federal Conditions of Participation if Medicare certification will follow.
- Quality improvement and program evaluation policy tied to the group of professional personnel's annual review obligation.
- Insurance certificates — general liability, professional liability, workers' compensation, and any required surety bond.
Submit this packet by email to [email protected] in a single PDF or a clearly-named multi-file bundle, and mail the fee separately. Include a cover letter that maps each exhibit to the section of Chapter 601 it satisfies — that single document removes more first-pass deficiencies than any other piece of the submission.
Common Deficiency-Letter Issues
Across the Pennsylvania applications we have seen, the same handful of issues account for the majority of deficiency letters. Each one is preventable with a careful first submission.
Thin ownership disclosure. The application requires every owner with at least a 5% interest, including indirect ownership through holding companies. Submissions that list only the operating entity routinely come back. Disclose the full chain.
Administrator and supervising clinician overlap. Where one person holds both roles, the position descriptions and time allocations need to be explicit. Reviewers are looking for evidence that both § 601.32 and § 601.33 obligations are being met, not assumed.
Group of professional personnel that is paper-only. A list of three names without a charter, a meeting cadence, or organizational minutes does not meet § 601.31. Constitute the group and hold the first meeting before submission.
HHA training program without a topic-hours breakdown. "75 hours of training" is not enough; the application document explicitly requires "clearly defined topics and hours per topic." Provide the syllabus.
Policies and Procedures manual that is generic. Off-the-shelf P&P templates that do not reference Pennsylvania-specific terms — Department of Health, Division of Home Health, Pennsylvania Nurse Aide Registry, Chapter 601 sections — read as cut-and-paste to a reviewer. Tag each policy to the regulation.
Missing sample chart. Subpart G policy without a sample chart format is a frequent finding. Build the sample chart even though you have no live patients yet.
Financial viability documentation gaps. While Chapter 601 does not state a specific capitalization minimum, the Department expects evidence that the agency can operate through its first survey cycle. Bank statements, capital contribution documentation, and a basic operating budget for the first 12 months close this gap.
Submission Logistics and Timing
The mechanical pieces of submission matter more than they should. Get them right the first time.
Email submission. Initial applications and exhibits go to [email protected]. Use a clear subject line that names the applicant entity. Multi-file submissions should be bundled in a logical structure (single zip or labeled PDFs) with a cover letter as the first document.
Fee mailing. The $250 license fee is mailed by check or money order, payable to "Commonwealth of Pennsylvania," to the Division of Home Health, 2525 N. 7th Street, Harrisburg, PA 17110. Hand delivery is not accepted. Note the application number or applicant name on the check memo line.
General correspondence. For non-application questions, the Division of Home Health general inbox is [email protected], and the office can be reached by phone at 717-783-1379.
Timeline expectations. Plan for 4 to 7 months from clean submission to license issuance, with another 30 to 60 days before the initial unannounced state licensure survey. The deficiency-letter cycle drives most of this — a packet that draws no deficiencies at all is rare, and each cycle adds 30 to 60 days. Do not sign a clinical lease, hire field staff, or accept your first referral until your license is in hand; § 601.18 penalties for pre-licensure operation are real, and any patient encounters before licensure typically cannot be billed.
Medicare certification follow-on. State licensure is a prerequisite for federal Medicare certification. Once licensed, agencies pursuing Medicare certification submit CMS Form 1572(a), CMS Form 690, CMS Form 1561 to the Division of Home Health, and CMS Form 855A to the Fiscal Intermediary, along with Federal Civil Rights Information for Medicare Applicants. Federal certification is governed by the CMS Conditions of Participation in 42 CFR Part 484, which overlaps with but does not duplicate Chapter 601. For the federal CoP layer that sits on top of Chapter 601 — Subparts A through C, the CY 2025 and CY 2026 final rule changes, HH QRP measures, and the SOM Appendix B survey protocol — see our working guide to 42 CFR Part 484.
After Submission: What Happens Next
Once your packet is in, three things happen on the Department's side. A licensure analyst is assigned and reviews the file against Chapter 601. If gaps are found, a deficiency letter is issued with a response window. When the file is clean, the Division issues an approval to operate that authorizes admission of the first patients, and an unannounced state licensure survey is scheduled. The survey examines clinical records, personnel files, the policies and procedures manual, and operational evidence that the policies are being followed in practice.
For new agencies, the survey is the first time the regulator sees the agency operating rather than on paper. Most first-survey findings are documentation issues — missing signatures on plans of treatment, gaps in the home health aide supervisory visit log, incomplete background-check files — rather than care quality issues. Build your operational habits in the first 30 days of admissions to match the policies your application described, and the first survey is straightforward.
Plan-of-correction practice in Pennsylvania is iterative the same way the application review is. A finding does not automatically threaten the license; what matters is the response. Acknowledge each finding, describe the corrective action with specifics, name the person responsible, and set a verification date. Most plans of correction are accepted on first or second submission.
Beyond Licensure: What Comes Next
Chapter 601 licensure is the gate, not the finish line. Pennsylvania agencies operating under Chapter 601 also need to manage Medicare conditions of participation if they are Medicare-certified, the Pennsylvania Department of Human Services rate environment for Medicaid-covered services (currently $20.63 per hour on average, with a Department of Human Services rate study recommending $25.42 per hour), Pennsylvania Department of Labor and Industry wage and overtime compliance under the state Minimum Wage Act, and the Pennsylvania Nurse Aide Registry processes for the HHA workforce.
The other operational reality is the workforce: more than 112,500 Pennsylvania home care shifts go unfilled each month, annual caregiver turnover runs near 80%, and the state ranks 50th nationally for home health aide wages. A clean Chapter 601 license is necessary, but recruiting and retention determine whether the licensed agency actually serves patients. The parent Pennsylvania state guide covers this side of the operating environment in detail, and our broader resources on reducing caregiver turnover and becoming an employer of choice are written for exactly this kind of new Pennsylvania agency.
If you want a structured way to assess your application package before submission — section by section, against Chapter 601 — start with our compliance readiness assessment. It walks through the same review logic a Division of Home Health analyst applies, scores your gaps, and produces an action list ordered by deficiency-letter risk.
Authoritative Sources
The primary regulatory and official sources for any Chapter 601 application are:
- 28 Pa. Code Chapter 601 — Home Health Care Agencies (Pennsylvania Code, official text)
- 28 Pa. Code Chapter 611 — Home Care Agencies and Home Care Registries (cross-reference for non-medical home care)
- PA Department of Health — Division of Home Health (initial application document, current revision)
- Pennsylvania Homecare Association (industry association, regulatory resources, advocacy)
- 42 CFR Part 484 — Medicare Home Health Conditions of Participation (federal CoPs that overlay state licensure for Medicare-certified agencies)
- CMS — Home Health Agency Certification (federal certification process and forms)
Verify the version current at the time you submit. Pennsylvania amends Chapter 601 from time to time, and the application document itself is revised periodically — the current revision as of this writing is dated February 4, 2025, and the Department does not accept earlier revisions.
The Bottom Line
The Pennsylvania application package is not difficult; it is exacting. Every Subpart of 28 Pa. Code Chapter 601 maps to specific exhibits in the package, every exhibit needs to be tagged to the section it satisfies, and every gap becomes a 60-to-90-day deficiency-letter delay. Founders who treat the application as a one-shot regulatory submission — fully built, fully cross-referenced, with a cover letter that walks the reviewer through Chapter 601 in the order they will read it — get to a regular license substantially faster than founders who iterate against the deficiency letter.
The Division of Home Health is not adversarial. The reviewers want to issue licenses to agencies that will operate competently, because that is how the program serves Pennsylvania's 2.48 million seniors. Make their job easy and they will make yours easy.
Building your Pennsylvania application package?
Our compliance readiness assessment walks your packet through the same Subpart-by-Subpart logic the Division of Home Health uses, scores your gaps, and produces an action list ordered by deficiency-letter risk. Then, when you are ready to staff, Home Health Workforce runs high-volume Pennsylvania caregiver recruiting on a pay-per-hire model.
Take the compliance readiness assessment