Brick Gentry P.C. Health Law April Update

By Iowa Healthcare Law Blog on April 30, 2026

This monthly update highlights key regulatory developments, enforcement trends, and compliance issues affecting health care providers across the continuum – from solo practices to hospitals and large physician groups. Each section includes practical action items to help you assess risk and prepare for upcoming obligations. April developments reflect increased scrutiny of emerging care delivery models, including medical spa services and technology-assisted care.

Regulatory Developments

Iowa CON Framework and Emerging Technology Risks

Iowa’s Certificate of Need (CON) program continues to evolve as policymakers evaluate the scope and applicability of facility and service regulation. The current CON framework is set forth at Iowa Code §§ 10A.711–10A.729, which governs review requirements for certain institutional health facilities, capital expenditures, and service expansions. Recent legislative activity reflects continued interest in modifying CON requirements, particularly with respect to review thresholds and applicability. Providers considering new facilities, capital expenditures, or service line expansions should evaluate whether proposed projects trigger CON review or fall within available exemptions under current law.

At the federal level, regulators continue to focus on emerging technology in healthcare, including the use of artificial intelligence in clinical decision-making, documentation, and administrative functions. Although comprehensive AI-specific regulation remains limited, existing requirements governing billing, documentation, and nondiscrimination apply regardless of the tools used, including obligations under 42 U.S.C. § 1320a-7k(d) (overpayments) and 45 C.F.R. Part 84 (Section 504 nondiscrimination).

Action Items:

Evaluate whether proposed expansions or capital projects trigger CON review under Iowa Code §§ 10A.711–10A.729.
Confirm whether any statutory exemptions apply to planned projects.
Inventory use of AI tools in clinical, billing, or administrative workflows.
Ensure human oversight and documentation protocols remain in place when AI tools are utilized.

Contracting Focus

Medical Director Oversight and GLP-1 Expansion in Iowa Medical Spa and Wellness Models

Regulators and licensing boards are increasingly scrutinizing supervision and delegation arrangements in Iowa medical spa and wellness clinic settings. This scrutiny has intensified as providers expand services involving injectables and weight-loss medications, particularly GLP-1 receptor agonists (e.g., semaglutide and tirzepatide). Demand for these therapies has also led to growth in compounded products, off-label prescribing, and direct-to-consumer care models, all of which raise additional regulatory and compliance considerations. In addition, emerging “next-generation” incretin-based therapies such as combination GLP-1 receptor agonists and other multi-agonist drugs are expected to further expand this space, increasing complexity around prescribing, supervision, and documentation.

In Iowa, medical spa services that constitute the practice of medicine must be performed by, or under the supervision of, a licensed physician, consistent with applicable scope of practice requirements. Physicians serving in a medical director role remain responsible for the medical services provided under their direction. Iowa Board of Medicine rules, including Iowa Admin. Code ch. 653-13 (Physician Practice) and Iowa Admin. Code r. 653-13.6, establish standards of physician practice and professional responsibility that apply regardless of the care setting. These responsibilities require meaningful physician involvement and cannot be satisfied through nominal or purely administrative oversight. Delegation and supervision are also informed by Iowa Admin. Code ch. 653-15 (Physician Assistants) and applicable nursing board rules. Collectively, these requirements mandate that delegated medical services be performed under appropriate physician oversight and within the training and competence of the individual performing the service.

In addition to scope of practice considerations, compensation and ownership structures in these models may implicate the Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b), and applicable safe harbors at 42 C.F.R. § 1001.952, particularly where compensation is tied to volume, referrals, or service utilization.

Action Items:

Confirm that all GLP-1 and related therapies are prescribed and administered by appropriately licensed individuals or under proper physician supervision.
Evaluate medical director arrangements to ensure active physician involvement, oversight, and accountability, consistent with Iowa Admin. Code r. 653-13.6.
Review policies addressing compounded medications and off-label use, including sourcing, prescribing protocols, and documentation practices.
Ensure patient evaluations support medical necessity and are not limited to questionnaire-based or asynchronous prescribing models.
Evaluate compensation and ownership arrangements for compliance with federal fraud and abuse laws.
Confirm that delegation protocols align with Iowa Admin. Code ch. 653-13 and ch. 653-15 and applicable scope of practice requirements.

Compliance Focus

Informed Consent and Documentation in AI-Assisted Care

As providers increasingly incorporate AI tools into clinical workflows, regulators are focusing on whether existing informed consent and documentation practices adequately reflect how care is delivered. While no uniform federal statute governs AI-specific consent, traditional informed consent principles continue to apply, including requirements that patients receive sufficient information to make informed decisions regarding their care. Use of AI-assisted documentation or coding tools may increase risk if outputs are not reviewed and validated by licensed providers. Inaccurate or unsupported documentation may create exposure under the False Claims Act, 31 U.S.C. §§ 3729–3733, particularly where claims are submitted based on deficient records. In addition, nondiscrimination requirements under 45 C.F.R. Part 84 (Section 504) apply regardless of whether care decisions are supported by automated tools, including potential concerns related to bias in algorithmic decision-making.

Action Items:

Review informed consent policies to address technology-assisted care where appropriate.
Confirm that AI-assisted documentation is reviewed and validated by licensed providers.
Evaluate whether patient communications accurately describe services being provided.
Train staff on appropriate use and limitations of AI-assisted tools.

Litigation and Risk Management Trends

Expansion of Consumer Protection and Licensing Enforcement
Recent enforcement trends reflect increased activity not only under federal fraud statutes, but also under state consumer protection laws and professional licensing frameworks. This is particularly evident in areas such as medical spas, weight-loss clinics, and direct-to-consumer healthcare models. In Iowa, enforcement risk may arise under the Iowa Consumer Fraud Act, Iowa Code § 714H.3, as well as through disciplinary authority exercised by state licensing boards. These cases often focus on advertising practices, supervision, scope of practice, and whether services are provided in a manner consistent with professional standards. Billing-related issues may also trigger repayment obligations under 42 U.S.C. § 1320a-7k(d) and 42 C.F.R. § 401.305.

Action Items:

Review marketing and advertising materials for compliance with Iowa Code § 714H.3 and applicable professional standards.
Confirm that services are provided within licensure and scope of practice parameters.
Evaluate supervision structures in higher-risk service lines.
Document compliance efforts and corrective actions where issues are identified.

FAQ of the Month

“Do we need to disclose use of AI tools to patients?”

There is currently no uniform federal requirement mandating disclosure of AI use in all circumstances. However, existing informed consent principles require that patients receive sufficient information to understand the nature of their care. If AI tools materially affect clinical decision-making, documentation, or communication, providers should consider whether disclosure is appropriate as part of the informed consent process. Clear documentation and provider oversight remain critical to reducing risk.

Upcoming Deadlines & Reminders

Section 504 Accessibility Requirements – Extended Compliance Date May 11, 2027: HHS has extended compliance deadlines for certain accessibility requirements under 45 C.F.R. Part 84, including web and mobile application accessibility for covered entities with 15 or more employees.
HIPAA Claims Attachment Standards – Effective May 26, 2026: Covered entities should continue preparing for implementation of standardized electronic claims attachment transactions and electronic signature requirements under 45 C.F.R. Part 162.
HIPAA Claims Attachment Compliance Deadline – May 26, 2028: Full compliance with the new transaction standards will be required within two years of the effective date.
Monthly OIG Exclusion Screening: Conduct monthly exclusion screening as recommended by OIG guidance using the List of Excluded Individuals and Entities (LEIE).
Medicare Revalidation (Rolling Deadlines): Providers should monitor for CMS revalidation notices and comply with deadlines stated in CMS communications.
Iowa CON and Insurance Reform Developments (HF 2635): Providers should monitor implementation of HF 2635 (2026), which has been enrolled and sent to the Governor and, if signed, is scheduled to take effect July 1, 2026.

Disclaimer: The information provided here is for general informational purposes only and does not constitute legal advice. No attorney-client relationship is created by this communication. Parties should consult with their own qualified attorney for advice regarding their specific legal situation.

For questions or assistance, contact Paul A. Drey or Emily E. Reiners of the Brick Gentry P.C. Healthcare & Regulatory Team.