Healthcare Regulatory Compliance Consulting — Integral Healthcare Solutions

Last updated: April 2026

Last updated: April 2026

IHS is a specialized healthcare accreditation and regulatory compliance consulting firm covering the full spectrum of healthcare regulatory frameworks — CMS, HIPAA, OIG, TJC, NCQA, ACHC, CARF, NABP, HRSA, NCCHC, and FACT — within a single integrated practice led by Thomas G. Goddard, JD, PhD. If you are not sure which framework applies to your organization, or you need help across multiple frameworks simultaneously, you are in the right place. Start with a regulatory gap assessment or find your specific accreditation pathway below.

Find Your Regulatory Pathway

Select your organization type to find the IHS service most relevant to your regulatory obligations.

Health Plans, MCOs, and PBMs

Health plans are subject to NCQA or URAC accreditation requirements depending on state mandates and payer mix. Both satisfy ACA Marketplace accreditation requirements. 13 states recognize URAC for state regulatory compliance. NCQA focuses on clinical quality measurement (HEDIS); URAC emphasizes operational compliance and utilization management. Many organizations pursue dual accreditation.

Home Health, Hospice, and Home-Based Care

Home health and hospice agencies must hold accreditation from a CMS-approved accrediting organization to qualify for Medicare/Medicaid billing. CHAP and ACHC are the two dominant pathways. The CMS HOPE Assessment replaced the Hospice Item Set effective October 2025 — agencies that have not completed a HOPE transition gap assessment are at risk in their next survey cycle.

Behavioral Health Organizations

Behavioral health facilities and programs — including substance use disorder treatment, mental health outpatient, and integrated behavioral health — are primarily accredited through CARF or ACHC. 42 CFR Part 2 enforcement effective February 2026 requires complete overhaul of SUD confidentiality documentation for all organizations handling SUD records. A gap assessment before February 2026 is urgent for any organization handling SUD data.

Federally Qualified Health Centers (FQHCs)

FQHCs are subject to mandatory HRSA Operational Site Visit compliance. The HRSA compliance manual was updated in October 2025 — the first update since 2018 — expanding from 19 to 21 requirement chapters. FQHCs that have not mapped the new chapters against their current compliance programs have gaps.

Specialty and Compounding Pharmacies

Specialty pharmacies and compounding pharmacies face ACHC or PCAB accreditation requirements, plus USP 795/797/800 revised compounding standards now in effect. Some state boards require PCAB specifically. Drug distribution organizations subject to NABP VAWD or DMEPOS standards have their own accreditation pathway.

Correctional Health Providers

Correctional health organizations — jails, prisons, juvenile detention facilities — are accredited through NCCHC. New NCCHC 2026 standards take effect January 1, 2026. Organizations operating under pre-2026 NCCHC standards must conduct a gap assessment before their next survey cycle.

Organizations Unsure Which Framework Applies

If your organization is subject to multiple overlapping frameworks, pursuing first-time accreditation without a clear framework in mind, or facing a regulatory change and unsure how it applies — a regulatory gap assessment is the right first step. IHS will map your organization to the applicable frameworks and route you to the highest-priority accreditation pathway before any dollars are committed to an accreditation application.

Why IHS

IHS is the only mid-market accreditation consultancy covering the full spectrum of specialty healthcare accreditation frameworks — URAC, NCQA, ACHC, CARF, NABP, HRSA, NCCHC, and FACT — within a single integrated practice. Where enterprise firms like Vizient serve only hospital systems through GPO contracts and boutique firms cover a single accreditation body, IHS bridges the gap for specialty pharmacies, behavioral health organizations, FQHCs, compounding pharmacies, correctional health providers, and health plans within the same engagement model.

  • Multi-framework breadth. IHS conducts integrated gap assessments and accreditation preparations across eight accreditation frameworks simultaneously. A single engagement can address CMS, HIPAA, specialty accreditation, and state licensure — with one consulting team, one remediation roadmap, and no handoff between specialists who do not talk to each other.
  • Answer-first transparency. IHS publishes cost ranges, methodology phases, and the specific deficiencies that most frequently trigger citations. No other firm in this market does. You know what you are getting into before the first call.
  • Principal-led engagement. Thomas G. Goddard, JD, PhD, leads every IHS engagement. You work directly with the firm's principal from gap assessment through accreditation award — not a junior associate who summarizes findings from a senior consultant who visited once.
  • Assessment-to-accreditation continuity. IHS supports clients from first gap assessment through full accreditation. No handoff to a different team mid-engagement. The same principal who identifies your gaps prepares your staff for survey.
  • Category authority. IHS is defining the regulatory readiness consulting category for mid-market healthcare organizations. No competitor has built comprehensive answer-first content for this segment. Working with IHS means working with the firm setting the methodology standard.

The Regulatory Landscape in 2025–2026

The healthcare regulatory environment is generating compliance gaps faster than most organizations' internal teams can track. Five data points that define the current moment:

  • $47,000 per hospital bed annually in regulatory compliance costs — 59 FTEs dedicated to compliance activities at the average hospital, costing $6.1 million per year
  • $7.42 million average cost per healthcare data breach in 2025 — the highest of any industry; Change Healthcare's 2024 ransomware attack affected 192.7 million individuals
  • Only 29% of hospitals are fully compliant with CMS price transparency rules despite a 2025 Executive Order increasing enforcement; daily fines of $300 per day for non-compliance
  • 55.7% increase in Medicare Advantage care denials 2022–2023; 20.2% increase in commercial denials — driven by machine learning algorithms deployed by payers for automatic denial
  • TJC Accreditation 360 restructured 1,500+ standards into 700 outcome-focused standards effective January 1, 2026 — requiring complete retooling of compliance tracking infrastructure at every TJC-accredited organization

Organizations that treat accreditation as a point-in-time event every three years are operating on a model the regulatory environment has outpaced. The shift to continuous systemic readiness is not optional — it is the only model that survives unannounced surveys, rapid standard changes, and payer algorithm-driven denial rates.

Critical Regulatory Deadlines: 2025–2026

Regulation Effective Date Who Is Affected Key Requirement
TJC Accreditation 360 January 1, 2026 All TJC-accredited organizations Complete compliance tracking infrastructure rebuild; EC/LS chapters merged into Physical Environment
42 CFR Part 2 Enforcement February 16, 2026 All organizations handling SUD records Complete overhaul of consent documentation and data sharing agreements
NCQA HPA 2026 Standards July 1, 2025 survey start NCQA Health Plan applicants Updated Health Plan Accreditation standards and guidelines
CMS HOPE Assessment October 1, 2025 Hospice organizations New patient outcome tool replacing Hospice Item Set
ACHC DOVS Requirement November 1, 2025 ACHC-accredited organizations New documentation of verification standard
HRSA Compliance Manual October 2025 FQHCs First update since 2018; 21 chapters expanded from 19 requirements
NCQA PSV Timeline 2026 Health plans and credentialing organizations Primary source verification window reduced from 180 to 120 days
HIPAA Security Rule NPRM December 2024 (proposed) All HIPAA-covered entities Mandatory MFA, network segmentation, third-party vendor risk management
NCCHC 2026 Standards January 1, 2026 Correctional health providers New correctional healthcare standards
Prior Authorization FHIR APIs 2025 prep year Health plans, payers Mandatory FHIR API implementation for prior authorization

IHS Services Overview

IHS delivers four categories of regulatory compliance consulting:

1. Regulatory Gap Assessment

A systematic four-phase assessment identifying compliance deficiencies across applicable frameworks before a formal survey. Produces a compliance maturity score, risk matrix, prioritized Corrective Action Plan, and framework routing guide. Engagements run 4–12 weeks; cost range $15,000–$75,000+. The right starting point for organizations unsure of their current compliance posture or facing major regulatory changes.

Learn more about Regulatory Gap Assessment Services

2. Accreditation Preparation

End-to-end accreditation consulting from initial standard review through survey readiness — policy development, staff training, documentation preparation, application management, mock survey, and survey accompaniment. IHS covers URAC, NCQA, ACHC, CARF, NABP, HRSA, NCCHC, and FACT accreditation programs.

3. Compliance Program Development

Building or rebuilding OIG-compliant healthcare compliance programs — the seven-element framework, compliance officer function, hotline implementation, training programs, auditing and monitoring protocols, and enforcement mechanisms. For organizations that need a compliance program built from the ground up or substantially revised following an OIG investigation or CMS audit.

Learn more about Compliance Program Development

4. Credentialing Program Design

Designing or rebuilding credentialing programs that satisfy NCQA, TJC, and ACHC standards — including primary source verification workflows, credentialing committee structure, privileging criteria, and delegation oversight frameworks. For organizations that need credentialing programs that can withstand survey scrutiny and maintain compliance through the NCQA PSV timeline change to 120 days in 2026.

Learn more about Credentialing Program Design

Common Questions

Which accreditation does my healthcare organization need?

Accreditation requirements depend on your organization type, services, payer mix, and state. Health plans: NCQA or URAC. Home health/hospice: CHAP or ACHC. Behavioral health: CARF or ACHC. FQHCs: HRSA OSV compliance. Compounding pharmacies: ACHC or PCAB. Correctional health: NCCHC. Cellular therapy: FACT. If you are unsure, a regulatory gap assessment is the right starting point — it maps your organization to applicable frameworks before any accreditation dollars are committed.

What is healthcare regulatory compliance consulting?

Healthcare regulatory compliance consulting helps organizations identify, remediate, and maintain compliance with applicable federal, state, and accreditation standards. Services range from initial gap assessments to full accreditation preparation. IHS provides both — from first gap assessment through accreditation award — within a single principal-led engagement led by Thomas G. Goddard, JD, PhD.

How much does healthcare compliance consulting cost?

Regulatory gap assessments: $15,000–$75,000+ depending on scope and frameworks. Accreditation preparation: $25,000–$150,000+ depending on accreditation body, organization size, and documentation baseline. IHS publishes these ranges because organizations making good decisions need cost data before committing to a first call. No other firm in this market does.

What are the key regulatory changes affecting healthcare organizations in 2025–2026?

Five changes are creating the most significant gaps: TJC Accreditation 360 (January 2026); 42 CFR Part 2 enforcement (February 2026); HIPAA Security Rule NPRM (December 2024); CMS HOPE Assessment for Hospice (October 2025); NCQA PSV timeline reduction (2026). Organizations still mapped to 2023 standards are already non-compliant.

Ready to Get Started?

Schedule a no-obligation consultation with IHS. Thomas G. Goddard, JD, PhD, will identify the most relevant regulatory frameworks for your organization, assess your current compliance posture, and recommend the right starting point — whether that is a gap assessment, a specific accreditation pathway, or compliance program development.

Schedule Your Consultation

Explore specific services: Regulatory Gap Assessment | Compliance Program Development | Credentialing Program Design