Section 30.1: Selecting Appropriate Accreditation (URAC/ACHC/TJC/NABP)

30.1.1 The “Why”: Accreditation as a Non-Negotiable Market Key

Welcome to one of the most significant strategic decisions you will make in the entire lifecycle of your specialty pharmacy. As an experienced pharmacist, your world has been defined by clinical excellence and patient care. You know how to manage complex therapies and counsel patients. But in the world of specialty pharmacy, clinical excellence is not enough. You can be the best clinical pharmacist in the world, but if you cannot get a contract, you cannot get a patient.

Accreditation is the key that unlocks the contracts.

In the traditional retail world, market access is primarily dictated by your pharmacy’s location and its PBM network contracts. In the specialty world, access is a fortified castle, and the guards at the gate are payers and pharmaceutical manufacturers. They will not even *speak* to you, let alone grant you access to their patients or their limited distribution drugs (LDDs), unless you have a “badge” of legitimacy. Accreditation is that badge.

This section is not a simple review of organizations. It is a strategic guide to help you deconstruct the complex, high-stakes decision of *which* accreditation to pursue. This choice will define your operational model, your quality program, your budget, and your timeline for years to come. It is the foundation upon which your entire business will be built.

The Four Pillars of Accreditation’s Value

Why invest hundreds of thousands of dollars and thousands of staff-hours into this process? Because it is the prerequisite for everything you want to achieve.

1. Payer Contracts (The #1 Reason): This is the primary driver. Major Pharmacy Benefit Managers (PBMs) like CVS Caremark, Express Scripts, and OptumRx will not allow you into their specialty pharmacy network without accreditation. Their RFPs (Request for Proposals) and network applications state this plainly: “Applicant must hold active Specialty Pharmacy Accreditation from URAC or ACHC.” Without this, you are invisible to them and locked out of the majority of the market.
2. Manufacturer Access (L-DDNs): Pharmaceutical manufacturers do not let just any pharmacy dispense their billion-dollar specialty drugs. They create Limited Distribution Drug Networks (L-DDNs) to ensure quality control, data reporting, and high-touch patient service. The application (RFP) to get into one of these networks has accreditation as a non-negotiable, check-the-box requirement. No accreditation = no access to the newest, most innovative therapies.
3. Competitive Differentiation & State Requirements: Having a seal of accreditation from URAC or ACHC is a powerful marketing tool. It signals to prescribers, patients, and health systems that your pharmacy operates at the highest standard of quality. Furthermore, a growing number of states are beginning to *mandate* specialty pharmacy accreditation as part of their licensure requirements, transforming this from a “best practice” to a “must-have” for legal operation.
4. Internal Quality Improvement (The “Good for You” Reason): While you pursue accreditation for the market access, the *process* of achieving it will fundamentally improve your pharmacy. It forces you to write down every process, define every role, create metrics for success, and build a culture of continuous quality improvement. It will make your operation more efficient, consistent, safe, and scalable.

The “Big Four” players you will hear about constantly are URAC, ACHC, The Joint Commission (TJC), and NABP. While other bodies exist, these are the four that dominate the landscape. Your task is not to determine *if* you will get accredited, but to strategically select *which* of these bodies best aligns with your specific goals, budget, and operational model.

30.1.3 Masterclass Deep Dive: URAC (Utilization Review Accreditation Commission)

Philosophy: “The Gold Standard” & The Data-Driven Auditor.

URAC is arguably the most recognized name in specialty pharmacy accreditation, particularly among payers and PBMs. This is because URAC’s history is in “Utilization Review”—they were founded to accredit the health plans themselves. As a result, their standards, mindset, and language are all built around business process rigor, risk management, and data-driven validation.

When you choose URAC, you are choosing to become a data-centric organization. They don’t just want to see your SOPs; they want to see the data that proves your SOPs are effective. Their standards are prescriptive, detailed, and focus heavily on management, oversight, and quantifiable performance.

Deconstructing the URAC Specialty Pharmacy Standards (v4.0)

The URAC standards are divided into “Focus Areas.” While you must meet all of them, the core of your work will be in these areas:

1. Risk Management (RM)

• What it is: A foundational set of standards requiring you to have a formal, documented risk management program.
• What it means for you: You must have an SOP for identifying, mitigating, and monitoring risks in all areas (clinical, operational, data). This includes designating a Risk Management leader, conducting an annual risk assessment, and having a business continuity plan (e.g., “What happens if your power goes out?”).
• Surveyor Mindset: “Show me your risk register. Show me your disaster recovery plan. What happened the last time you had a dispensing error, and what was your Root Cause Analysis (RCA)?”

2. Patient Management (PM)

• What it is: This is the *heart* of the URAC SP standards. It details every step of the patient journey and is extremely granular.
• What it means for you: This single focus area will spawn dozens of SOPs. Key components include:
  • PM 1 (Intake): A detailed SOP for patient intake, including all required data points.
  • PM 2 (Patient Assessment): A process for conducting an initial clinical assessment by a pharmacist.
  • PM 3 (Care Plan): A requirement for individualized, patient-specific care plans with measurable, long-term goals.
  • PM 4-6 (Patient Monitoring): This is the core of URAC’s “Therapeutic Area Management.” You must have disease-specific protocols for proactive patient follow-up (e.g., adherence checks, side effect management).
  • PM 8 (Coordination of Care): A formal process for communicating with prescribers, including notification of non-adherence or critical side effects.
  • PM 10 (Patient Education): You must have written, evidence-based patient education materials for all your core diseases.
• Surveyor Mindset: “Pull 10 patient charts for me. Show me the initial assessment for Patient A. Where is their individualized care plan? I see they are on an oncology drug; show me your adherence follow-up call script. I see in Patient B’s chart they reported a side effect; show me where you documented your intervention and the communication to the prescriber.”

3. Pharmacy Operations (PO)

• What it is: The “nuts and bolts” of dispensing and shipping.
• What it means for you: Meticulous SOPs for prescription validation, dispensing accuracy (your “quality check” process), and cold-chain management. This includes validation reports for your shipping coolers (e.g., “Prove this cooler keeps a drug cold for 48 hours in the summer in Arizona”).
• Surveyor Mindset: “Show me your daily refrigerator temperature logs. Show me your cooler validation study. Show me your SOP for what to do if a patient reports a warm package.”

4. Performance Measurement & Reporting (MEAS)

• What it is: This is the great URAC differentiator. URAC mandates that you collect, analyze, and report on specific Key Performance Indicators (KPIs).
• What it means for you: You *must* have a system (and likely, software) to track:
  • Call Center Performance: Average speed to answer, call abandonment rate.
  • Dispensing Accuracy: Your internal dispensing error rate.
  • Turnaround Time (TAT): Time from referral to drug shipment.
  • Clinical Metrics: Adherence rates (e.g., Medication Possession Ratio – MPR), side effect intervention rates, etc.
• Surveyor Mindset: “Show me your quarterly KPI report for the last two years. I see your call abandonment rate spiked in Q2. Show me the root cause analysis you performed and the corrective action plan you implemented.”

The URAC Process, Timeline, and Cost

Process: URAC’s process is unique and academic.

1. Application: You apply and pay the fee.
2. Phase 1: Desktop Review: You upload all your SOPs, policies, and supporting documents to URAC’s online portal. A reviewer audits them on paper first. This is an intense, iterative process where the reviewer will send you corrections (“Your PM 3 SOP is missing a policy on measurable goals. Please revise and resubmit.”).
3. Phase 2: Validation Review: Once your “paper” application is perfect, URAC schedules the “Validation Review” (this used to be on-site, but is now often virtual). This is where they conduct tracer audits and interviews to prove you are following the SOPs you submitted.
4. Phase 3: Committee Decision: Your application goes to a committee for a final yes/no.

Timeline: Be patient. 12 to 18 months is a realistic timeline from application to accreditation. The Desktop Review phase alone can take 6-9 months.

Cost: The highest of the group. Expect to spend $30,000 – $50,000+ just on URAC fees (application, annual fees, etc.) for a single location, not including your internal costs (consultants, software, staff time).

30.1.4 Masterclass Deep Dive: ACHC (Accreditation Commission for Health Care)

Philosophy: “The Patient-Centric Standard” & The Collaborative Educator.

ACHC has rapidly emerged as a co-equal to URAC in the eyes of most payers and manufacturers. Its origin story is different—it was founded by pharmacists and has a deep history in home infusion and community pharmacy. As a result, its standards and survey process feel more collaborative, educational, and patient-centric.

When you choose ACHC, you are choosing a partner. The survey process is less of a “pass/fail audit” and more of a “consultative review” designed to help you improve. The standards are equally comprehensive to URAC’s but are often framed around the patient journey and patient rights, rather than business processes and data metrics.

Deconstructing the ACHC Specialty Pharmacy Standards

ACHC’s standards are also divided into sections, with a very logical flow that follows the patient’s experience.

1. Patient Intake & Assessment (PIA)

• What it is: This covers the initial referral and patient onboarding.
• What it means for you: Similar to URAC, you need a defined intake process. ACHC is particularly focused on Patient Rights & Responsibilities. You must prove that you provide patients with a “welcome packet” that clearly explains their rights, the pharmacy’s services, financial responsibilities, and how to file a complaint.
• Surveyor Mindset: “Show me your Patient Rights & Responsibilities document. Now, pull 5 new patient charts. Show me where you documented that this information was provided to the patient and that they understood it.”

2. Care Planning & Coordination (CPC)

• What it is: This is ACHC’s version of URAC’s “Patient Management.”
• What it means for you: You must develop, implement, and monitor a patient-specific Plan of Care. ACHC’s standards are very clear that this plan must be coordinated with the prescriber and shared with the patient. They emphasize collaboration. This section also includes requirements for disease-specific patient education and assessing social determinants of health (SDOH).
• Surveyor Mindset: “Let’s trace a patient. Show me the initial referral. Now show me the Plan of Care. How was this plan developed with the prescriber? How did you communicate this plan to the patient? I see the patient reported a barrier to access; where is that documented in the care plan and what was your intervention?”

3. Dispensing & Delivery (DD)

• What it is: The “nuts and bolts,” similar to URAC’s Pharmacy Operations.
• What it means for you: All the same requirements for dispensing accuracy, pharmacist verification, and cold-chain management. ACHC surveyors, often being pharmacists themselves, are very adept at physically touring your pharmacy and spotting non-compliance (e.g., a messy compounding area, disorganized refrigerators).
• Surveyor Mindset: “Let’s walk the pharmacy. Show me your clean room. Show me your temp logs. Explain your workflow from data entry to final pharmacist check. What happens if a pharmacist finds an error? Show me the SOP.”

4. Quality Monitoring & Improvement (QMI)

• What it is: This is ACHC’s Quality Program requirement.
• What it means for you: You must have a formal Quality Improvement (QI) program. This includes collecting data, but ACHC is less prescriptive than URAC about *what* you must measure. They want to see that you have identified meaningful metrics (e.g., patient satisfaction, error rates, adherence), that you track them, and that you have a QI Committee that meets regularly to review them and take action. You must also track and trend patient complaints and incidents.
• Surveyor Mindset: “Show me the minutes from your last two QI Committee meetings. I see you discussed a trend of shipping delays. What was your root cause analysis? What corrective action plan did you implement? How are you measuring if that action was effective?”

The ACHC Process, Timeline, and Cost

Process: ACHC’s process is more straightforward and surveyor-centric.

1. Application: You apply and pay the fee.
2. Phase 1: Workshop (Optional but Recommended): ACHC offers workshops to *teach* you the standards. This is a huge part of their “educational” philosophy.
3. Phase 2: Survey: This is the main event. An ACHC surveyor (or team) comes on-site (or virtually) for 1-2 days. They will review your SOPs, but their primary method is the patient tracer. They will pick a patient and follow their chart from “referral to refill,” interviewing every staff member who touched that patient’s record.
4. Phase 3: Plan of Correction & Decision: After the survey, they give you a report. If you have deficiencies, you submit a “Plan of Correction” (PoC) explaining how you will fix them. Once your PoC is approved, you are accredited.

Timeline: Significantly faster than URAC. A dedicated pharmacy can often achieve accreditation in 9 to 12 months. The lack of a separate, months-long “Desktop Review” is a major accelerator.

Cost: More affordable. While still a major investment, total fees are typically in the $20,000 – $30,000 range. ACHC is often seen as the best “value” for the dollar, given its equal market recognition.

30.1.5 Masterclass Deep Dive: TJC (The Joint Commission)

Philosophy: “The Health-System Standard” & The Patient Safety Behemoth.

The Joint Commission is the 800-pound gorilla of healthcare accreditation. They accredit the entire hospital, from the emergency room to the surgical suite to the cafeteria. For a specialty pharmacy, TJC is generally only relevant if you are part of a TJC-accredited health system.

If your pharmacy is a department within a hospital, you will almost certainly be accredited under the hospital’s TJC umbrella. You won’t be seeking “Specialty Pharmacy” accreditation as a standalone product, but rather demonstrating compliance with TJC’s chapters on Medication Management (MM) and National Patient Safety Goals (NPSGs) as part of the hospital’s overall survey.

Deconstructing TJC Standards for a Specialty Pharmacy

TJC’s standards (called “Elements of Performance” or EPs) are not in a neat “Specialty Pharmacy” box. They are spread across massive chapters.

• National Patient Safety Goals (NPSGs): You must be in 100% compliance. For pharmacy, this includes:
  • NPSG.03.04.01: Labeling all medications.
  • NPSG.03.05.01: Reducing harm from anticoagulants.
  • NPSG.03.06.01: Maintaining and reconciling accurate medication lists (Med Rec).
• Medication Management (MM) Chapter: This is your primary home. It covers everything from formulary selection to ordering, preparing, dispensing, administering, and monitoring medications. The standards are broad and safety-focused.
• Environment of Care (EC) Chapter: Covers medication storage, refrigerator safety, fire safety, and (if you compound) clean room standards (linking to USP 797/800).
• Human Resources (HR) Chapter: You must have documented competency assessments for all pharmacists and technicians, proving they are trained for their roles.

The TJC Process, Timeline, and Cost

Process: The TJC survey is a legendary and high-stakes event for a hospital.

1. Continuous Readiness: You are *always* survey-ready.
2. The Survey: TJC arrives unannounced for a multi-day, multi-surveyor event. They will swarm the hospital.
3. Pharmacy Tracer: A surveyor (often a pharmacist) will absolutely do a “Medication Management” tracer. They will pick a patient, look at their complex drug regimen, and trace it all the way from the prescriber’s order to the pharmacy’s verification, to the nurse’s administration, looking for any gaps. Your specialty pharmacy will be a key part of this.

Timeline: Accreditation is on a 3-year cycle, but the “survey window” is a constant state of readiness.

Cost: Enormous for a full hospital, but “included” if you are a hospital department. A standalone pharmacy would almost never pursue this due to the cost and complexity, which is far beyond what is needed for SP accreditation alone.

30.1.6 Masterclass Deep Dive: NABP (National Association of Boards of Pharmacy)

Philosophy: “The Pharmacy Compliance Standard” & The Licensure Experts.

NABP is the parent organization of all the state Boards of Pharmacy. Their focus has traditionally been on ensuring pharmacies are licensed, compliant, and part of a safe and legitimate supply chain. Their accreditation programs (like the former VIPPS for online pharmacies) are extensions of this mission.

NABP’s Specialty Pharmacy accreditation is a comprehensive set of standards, but it comes from a “pharmacy practice” and “compliance” angle, rather than a “health plan” (URAC) or “patient-centric” (ACHC) angle. It is excellent at what it does, but it has one critical weakness: market recognition.

Deconstructing the NABP Standards

NABP’s standards are practical and pharmacy-focused, covering:

• Patient Management: Includes policies for intake, care planning, TTM, and patient education.
• Pharmacy Operations: Dispensing, shipping, accuracy, and storage.
• Business & Legal Compliance: This is a major focus. NABP heavily vets your state licensures, your relationships with wholesalers, and your compliance with all state and federal laws (e.g., PDMA).
• Patient Safety: Requires a QRE (Quality-Related Event) program, root cause analysis, and patient communication.

The NABP Process, Timeline, and Cost

Process: A straightforward application and survey model.

1. Application: You apply and submit your documentation for review.
2. Survey: An on-site (or virtual) survey is scheduled to verify your operations and compliance with standards.
3. Decision: A committee reviews the survey findings and grants accreditation.

Timeline: Generally quite fast, often under 9 months.

Cost: Moderate, comparable to or slightly less than ACHC.

30.1.7 The Head-to-Head Showdown: Comparative Decision Matrix

Let’s put all this information into a single, high-level table to help you compare your options at a glance. For most new, standalone specialty pharmacies, the choice will come down to URAC vs. ACHC.

30.1.8 Tutorial Guide: How to Make Your Decision in 5 Steps

This decision can be paralyzing. Here is a practical, step-by-step process to determine the right path for your specific pharmacy.

Step 1: The Health System Check (The TJC Litmus Test)

This is the first and easiest question.
Ask: “Is my specialty pharmacy a department or entity within a larger hospital or health system?”

• If YES: Your decision is likely made for you. Find out if the parent system is TJC accredited. If they are, you will almost certainly pursue TJC accreditation under their umbrella. Your next call is to your hospital’s Director of Quality or Compliance.
• If NO: You are an “independent” or “standalone” entity. Proceed to Step 2. TJC is not for you.

Step 2: The Payer & Manufacturer Mandate (The Market Research)

This is the most critical step. Do not guess. You must get data. Your choice is now URAC vs. ACHC.
Action: Identify your Top 10 “must-have” contracts. This includes your top 5 target PBMs/payers and the top 5 L-DDN drugs you want to dispense.

Action 1: Call the PBMs. Get on the phone with provider relations or the pharmacy network department.
Action 2: Find the L-DDN RFPs. Go to the manufacturer websites (or use industry contacts) to find the “Request for Information” or “RFP” documents for their specialty drugs. These documents will explicitly state the accreditation requirements.

Step 3: The Budget & Timeline Reality Check

Now that you know URAC and ACHC are the two viable options, you must look inward.

• Timeline: How fast do you need to be in-network? Is your business plan dependent on getting contract revenue in 12 months?
  • If speed is the #1 priority, ACHC is generally the faster path (9-12 months).
  • If you have a longer runway, URAC’s 12-18 month timeline is manageable.
• Budget: What is your *total* all-in budget (fees, consultants, software)?
  • If your budget is leaner, ACHC is the more cost-effective option.
  • If your budget is larger and you are prioritizing prestige, URAC is a viable choice.

Step 4: The Cultural & Operational Fit

This is the “feel” part of the decision. How do you want to run your business?

• Choose ACHC if: You and your team value a collaborative, educational partner. You want a surveyor who will teach you and help you improve. Your focus is on building amazing, patient-centric clinical programs.
• Choose URAC if: You and your team are highly data-driven, analytical, and process-oriented. You value a prescriptive, rigorous framework that *forces* data hygiene and KPI reporting. You want the “Harvard” brand name.

Step 5: The Final Decision (The 80/20 Rule)

For 80% of independent specialty pharmacies, the analysis from Steps 1-4 leads to a clear conclusion: ACHC is the strategic choice.

It provides the *same market access* as URAC, but does so *faster* and at a *lower cost*, with a *more collaborative process*. The market has largely equalized, and the “prestige” of the URAC brand no longer outweighs the significant time and cost benefits of ACHC for most new pharmacies.

URAC remains the “gold standard” and the right choice for large, data-heavy, PBM-owned organizations, but ACHC has become the smart, strategic choice for the independent entrepreneur.

30.1.9 The “Gotchas”: Common Accreditation Pitfalls to Avoid

This process is a minefield of common, costly mistakes. Your preparation for this journey must include awareness of these traps.

30.1.10 Conclusion: Your Blueprint for Legitimacy

Choosing your accreditation body is the single most important strategic decision you will make as a new specialty pharmacy. It is the foundation of your entire operation, the literal “key” that unlocks the market, and the blueprint for your quality program.

You have translated your existing skills in “clinical quality” to “business quality.” You understand that this is not an academic exercise but a high-stakes business decision. For the vast majority of you, this decision will be a head-to-head comparison of URAC (the Data-Driven Gold Standard) and ACHC (the Patient-Centric Collaborative Partner).

By following the 5-step decision guide—checking your health system status, conducting payer research, and analyzing your budget, timeline, and culture—you can make an informed, data-driven choice that is right for *your* pharmacy.

Now that you have selected your “university” and know which “textbook” (standards) you will be tested on, the real work begins. The next section, 30.2, will provide the architecture for building the “SOP tree” that will serve as the core of your application and the operating manual for your entire pharmacy.