Do You Need a Medical Director for Wound Care & Home Health Agencies? 2025 Compliance Guide

Every day, millions of Americans rely on home health nurses and wound care clinics to recover from surgery, manage chronic illnesses, and prevent infections. What patients don’t see is the compliance structure that makes these services legal and billable. 

Behind every licensed home health agency or wound care clinic, there’s a medical director ensuring safety, signing off on care plans, and keeping providers in line with state and federal laws.

If you’re asking: “Do I need a Medical Director to run a wound care clinic or home health agency?”

The answer is almost always: Yes.

At Medical Director Co., wound care and home health are among our fastest-growing verticals. We place physicians nationwide within 24 hours, starting at just $799/month, with free collaborative agreements and MSOs where required.

Many of our Medical Directors are licensed in multiple states, making us the go-to partner for regional and national wound care chains, including several companies from the Northeast, Midwest, and Canada that are rapidly scaling across the U.S.

Why Medical Directors Are Required

• Wound Care: Advanced dressings, negative pressure therapy, and prescribing antibiotics require physician oversight.
• Home Health: To bill Medicare or Medicaid, agencies must have a physician overseeing patient care.
• Chart Reviews: Nurses and aides can only work under physician-approved care plans.
• Liability: Accrediting bodies require documented physician leadership.

CMS & Accreditation Requirements

The Centers for Medicare & Medicaid Services (CMS) mandates that home health agencies:

• Have a designated physician to review and approve patient care plans.
• Meet Conditions of Participation for billing (see 42 CFR Part 484).

Accreditation bodies like the Joint Commission, Community Health Accreditation Partner (CHAP), and Accreditation Commission for Health Care (ACHC) require:

• Written Medical Director agreements.
• Documented physician oversight of clinical operations.

Without a medical director, agencies cannot bill Medicare, Medicaid, or most insurers.

Industry Growth: Why Wound Care & Home Health Are Booming

• Chronic Wounds: According to the CDC, over 38 million Americans have diabetes, a leading cause of chronic wounds.
• Aging Population: By 2030, one in five Americans will be over 65, driving demand for home health.
• Cost Savings: Home health and outpatient wound care reduce hospital stays, making them a preferred option for payors.

Where the Growth Is Coming From

In 2025, the fastest expansion isn’t just local entrepreneurs—it’s large regional and international players scaling nationwide.

• Northeast: New York, New Jersey, and Pennsylvania companies are opening dozens of wound care clinics.
• Midwest: Groups from Illinois, Michigan, and Ohio are scaling multilocation wound care operations.
• Canada: Several Canadian-based healthcare companies are expanding into the United States, opening wound care clinics across multiple states.

Many of these companies rely on Medical Director Co. because:

• We provide experienced wound care physicians with backgrounds in advanced therapies.
• Many of our medical directors for wound care are licensed in multiple states, simplifying expansion.
• Our legal team prepares collaborative agreements and MSOs free, even for large multistate operations.

We’re proud to say wound care is one of our specialties—we’ve helped dozens of groups launch at scale.

Step-by-Step Medicare Certification Process for Home Health

For home health agencies, Medicare certification is often the biggest hurdle. Here’s how it works and where the medical director fits in.

1. Business Formation & Licensing

• Form your legal entity (LLC or corporation).
• Apply for a state home health license.
• Hire a medical director. Most states won’t approve the license without an MD listed.

2. Enroll in Medicare

• File the CMS-855A enrollment form.
• Identify your medical director as the supervising physician.

3. Develop Policies & Procedures

• They must reflect the CMS Conditions of Participation.
• The medical director must sign off on patient care protocols.

4. Hire Staff & Set Up Clinical Operations

• Hire RNs, LPNs, aides, and therapists.
• The medical director approves the scope of care and delegations.

5. Survey/Accreditation Visit

• State surveyors or an accrediting body (Joint Commission, CHAP, ACHC) will evaluate your agency. They will specifically ask for:
  • A signed medical director agreement.
  • Evidence of physician-reviewed care plans.

6. Final Approval & Billing

• Once approved, your agency can bill Medicare.
• The medical director must review care plans on an ongoing basis (typically every 60 days).

Without a medical director, your Medicare certification process will fail at step 1.

Top 5 Mistakes Home Health Agencies Make Without a Medical Director

1. Trying to Use a Generic Template

 

Agencies download free Medical Director agreements online. Surveyors reject them for missing CMS-required language.

2. Delaying Physician Placement Until After Application

Many agencies apply first and then scramble to find a physician. States will not process licenses without a listed medical director.

3. Hiring Attorneys for MSOs/Agreements

Attorneys charge $5000–$15,000 for compliance documents but don’t provide a physician.

4. Assuming RNs Can Operate Independently

Even in NP-friendly states, Medicare requires physician oversight.

5. Underestimating Multistate Complexity

Expanding into at least two states requires different agreements per state. We solve this with multistate medical directors and free legal prep.

The Role of the Medical Director in Wound Care & Home Health

• Approves and oversees patient care plans.
• Supervises nurses, aides, and mid-level providers.
• Ensures compliance with CMS, state, and accreditation rules.
• Reviews charts and outcomes regularly.
• Provides prescribing authority for wound care supplies, antibiotics, and adjunct therapies.

The Cost of Medical Directors for Wound Care & Home Health

• Industry Average: $1200–$2500/month
• Consultants/Attorneys: Often charge $2000–$5000 upfront in “placement” or “document prep” fees
• Medical Director Co.: $799/month, no placement fees, free MSOs & collaborative agreements, 24-hour placement.

Comparison: Attorney vs Template vs Medical Director Co.

Provider	Cost	Customization	Physician Provided?	Risk
Free Template	$0	Generic	No	CMS rejection, failed audit
Attorney	$5000–$15,000	Custom	No	Expensive, and you’re still without an MD
Medical Director Co.	$799/month	Custom (free state-specific legal docs)	Yes	Low

State-by-State Requirements

Every state is different, but here’s how to group them.

• Strict CPOM States (Require MSOs): CA, TX, NY, NJ, IL, GA, NC
• Medicare/Medicaid Heavy Oversight States: FL, OH, PA, MI
• NP-Friendly States (But still require MD for CMS billing): WA, OR, AZ, CO

We prepare collaborative agreements and MSOs free for all 50 states:

• Alabama
• Alaska
• Arizona
• Arkansas
• California
• Colorado
• Connecticut
• Delaware
• Florida
• Georgia
• Hawaii
• Idaho
• Illinois
• Indiana
• Iowa
• Kansas
• Kentucky
• Louisiana
• Maine
• Maryland
• Massachusetts
• Michigan
• Minnesota
• Mississippi
• Missouri
• Montana
• Nebraska
• Nevada
• New Hampshire
• New Jersey
• New Mexico
• New York
• North Carolina
• North Dakota
• Ohio
• Oklahoma
• Oregon
• Pennsylvania
• Rhode Island
• South Carolina
• South Dakota
• Tennessee
• Texas
• Utah
• Vermont
• Virginia
• Washington
• West Virginia
• Wisconsin
• Wyoming

Case Studies

Case 1: Texas Home Health Startup

Maria, an RN, spent 3 months applying for a home health license. The state denied her because her medical director agreement didn’t meet CMS language. 

With us:

• Physician placed within 24 hours
• Legal docs prepared free
• Agency approved and billing Medicare within 30 days

Case 2: Florida Wound Care Chain

A Canadian company expanding into Miami needed physicians in three states. Attorneys quoted $10,000+ per MSO. 

With us:

• Three medical directors placed in a week, with free multistate MSOs
• Eight clinics launched in 90 days

Case 3: California Investor

A business owner wanted to open a wound care center in Los Angeles. The free template MSO they got gave the physician equity. 

With us:

• MSO rewritten for free
• An MD was placed, but the investor kept 100% control.
• Launched for $799/month

Risks of Operating Without a Medical Director

• CMS Denials: Medicare/Medicaid claims get rejected.
• Licensing Issues: States won’t approve agencies without MD oversight.
• Audit Failures: Accreditation bodies require MD agreements.
• Financial Risk: Clinics shut down mid-launch waste $50,000–$100,000 in startup costs.

FAQs

Is a medical director legally required for home health agencies?

Yes, CMS requires it for Medicare billing.

Can an RN open a wound care clinic?

Only with a physician medical director (or MSO structure in CPOM states).

Can I use an attorney or consultant template?

You can, but they cost $5000–$15,000 and don’t include a physician.

Do you cover all 50 states?

Yes, our legal team prepares CPAs and MSOs free nationwide.

Takeaway

Wound care and home health are among the fastest-growing healthcare sectors in America. But they’re tightly regulated. Without a medical director, you cannot:

• Bill Medicare/Medicaid.
• Pass accreditation.
• Legally supervise nurses or order wound supplies.

At Medical Director Co., we’ve helped everyone from solo RNs to large multistate wound care chains (including Canadian companies expanding into the United States) launch successfully.

• $799/month
• No placement or setup fees
• Free collaborative agreements + MSOs
• Physicians placed within 24 hours
• Multistate coverage available

Contact us today and scale your wound care or home health agency with confidence.