2025 Florida Compliance Master Guide: Designated Health Services (DHS) & Stark Law Requirements

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This comprehensive guide explains Designated Health Services, Stark Law rules, and key compliance requirements for Florida healthcare providers. Learn how DHS affects referrals, financial relationships, audits, and risk management, and discover essential steps practices must follow to rema

For Florida healthcare providers, understanding Designated Health Services (DHS) is no longer optional—it's a core compliance responsibility. Federal enforcement has intensified, CMS audits have increased, and AHCA now places heightened scrutiny on medical practices involved in diagnostic testing, imaging, DME, therapy services, and hospital-based service lines.

This guide provides the most current, detailed, and compliance-oriented explanation of DHS rules, Stark Law exceptions, common audit triggers, and the legal steps providers must follow to stay compliant in 2025.

What Are Designated Health Services?

DHS refers to specific categories of healthcare services regulated under the federal Physician Self-Referral Law (Stark Law). These services represent areas with high referral volume and are therefore monitored closely to prevent financial conflicts of interest.

DHS includes:

  • Clinical laboratory services

  • Physical and occupational therapy

  • Radiology, MRI, CT, and diagnostic imaging

  • Durable medical equipment (DME) and supplies

  • Prosthetics and orthotics

  • Parenteral and enteral nutrients

  • Home health services

  • Outpatient prescription drugs

  • Inpatient and outpatient hospital services

Because these categories generate significant Medicare claims, improper referrals can result in substantial penalties.

Why DHS Compliance Matters More in Florida

Florida consistently ranks among the highest states for:

  • Healthcare fraud investigations

  • CMS billing audits

  • OIG enforcement actions

  • AHCA site inspections

  • Medicare overpayment recoveries

Stark Law violations involving DHS can lead to:

  • Civil monetary penalties exceeding $15,000 per service

  • Repayment of all Medicare claims tied to improper referrals

  • False Claims Act liability

  • Program exclusion and loss of credentialing

  • Contract terminations with payors

Even unintentional errors—like expired contracts, informal leases, or undocumented supervision—can trigger major compliance issues.

Core Stark Law Rules Governing DHS

DHS compliance revolves around strict, zero-flexibility rules. Providers must understand the following:

1. Financial Relationships Must Be Properly Structured

Any financial relationship between a physician and an entity providing DHS must be:

  • Documented in writing

  • Signed by all parties

  • Commercially reasonable

  • Set at fair market value

  • Not tied to referral volume

Informal or expired agreements remain the #1 cause of Stark violations.

2. Fair Market Value (FMV) Documentation

FMV must support:

  • Physician compensation

  • Medical director agreements

  • Diagnostic supervision payments

  • Space/equipment rental rates

  • Call coverage contracts

CMS expects FMV analyses to be updated routinely, especially when reimbursement trends shift.

3. Stark Law Exceptions Must Be Met Completely

Common exceptions for DHS include:

  • In-office ancillary services

  • Bona fide employment

  • Personal service arrangements

  • Space and equipment leases

  • Group practice exceptions

Missing even one technical requirement—such as the one-year term, signature, or FMV documentation—invalidates the entire exception.

4. Group Practices Must Meet Federal Standards

A practice must satisfy specific criteria to qualify as a Stark-compliant group, including:

  • Unified business operations

  • Central decision-making structure

  • Integrated medical and financial systems

  • Defined profit distribution models

In Florida, many practices fail this test due to inconsistent administrative policies or outdated group structures.

5. Shared Space, Time-Share, & Co-Location Risks

Florida providers frequently operate:

  • Shared imaging suites

  • Part-time office locations

  • DME storage areas

  • Therapy rooms with rotating schedules

Every arrangement must be documented with precise:

  • Time blocks

  • Exclusive-use requirements

  • Fair market rental calculations

  • Non-referral-based payment terms

CMS has repeatedly cited co-location arrangements as high-risk.

Common DHS Compliance Problems in Florida Practices

Florida Healthcare Law Firm has identified the following recurring patterns during client audits:

1. Informal or Verbal Agreements

Providers often collaborate without written contracts—creating immediate Stark exposure.

2. Non-Compliant Imaging Agreements

MRI, CT, and ultrasound centers face the highest risk due to supervision, space rental, and referral relationships.

3. Inaccurate or Outdated FMV Assessments

Many compensation arrangements are based on old market rates or unsupported benchmarks.

4. Misclassification of Workers

Physicians classified as independent contractors without proper documentation often generate DHS compliance failures.

5. Lack of Referral Tracking

Many practices do not track DHS referrals accurately, making it impossible to detect internal compliance violations.

6. Overlapping Time-Share Leases

Shared medical space requires extremely precise contract language. Florida audits routinely flag these setups.

How Florida Healthcare Law Firm Helps Providers Achieve DHS Compliance

Our attorneys offer full-spectrum compliance support, including:

  • Stark Law and DHS compliance audits

  • FMV and commercial reasonableness analysis

  • Physician employment and contractor agreement reviews

  • Lease and time-share compliance restructuring

  • Diagnostic supervision policy development

  • DME and imaging compliance assessments

  • Internal referral monitoring systems

  • AHCA, CMS, and OIG audit response support

We ensure that your financial relationships, contracts, supervision models, and operational structures align with federal and state regulations.

Best Practices for DHS Compliance in 2025

To minimize audit risk, Florida healthcare entities should:

  1. Conduct a full annual compliance review

  2. Renew contracts before expiration

  3. Maintain current FMV reports

  4. Standardize supervision requirements

  5. Use written documentation for all financial arrangements

  6. Avoid referral-based compensation

  7. Maintain detailed logs for time-share and space use

  8. Train staff on DHS categories and Stark rules

  9. Implement a referral oversight program

Practices that follow these steps significantly reduce exposure to penalties and investigations.

Conclusion

DHS compliance remains one of the most critical legal responsibilities for Florida healthcare providers. As enforcement intensifies, practices must strengthen documentation, refine internal controls, and proactively monitor their contractual and financial arrangements. With expert legal guidance and a structured compliance program, your organization can confidently operate within Stark Law and federal DHS regulations while reducing audit risk.

For personalized support and professional compliance evaluation, Florida Healthcare Law Firm provides strategic guidance to help providers meet every Designated Health Service requirement and maintain long-term regulatory protection.

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