If you are a site of care dispensing practice, you are well aware of the pressures being placed on you by Pharmacy Benefit Managers (PBMs):
- Limited distribution
- Restrictive pharmacy networks
- Applications and certification processes
- Direct and indirect remuneration (DIR) fees
- Cumbersome authorization processes
- Limiting prescriptions after the first fill
Many PBMs are now requiring that site of care dispensing programs have specialty pharmacy certification or accreditation in order to participate in their specialty networks. This can mean certifications specific to a PBM, or requirements that your program be accredited by one or more accrediting bodies.
To address these challenges, becoming certified by a recognized specialty pharmacy accreditation body will help your practice demonstrate that you can meet the same standards as commercial pharmacies as well as meet any additional requirements or restrictions set forth by PBMs.
The two most common accreditations for specialty site of care dispensing programs are ACHC (Accreditation Commission for Health Care) and URAC (Utilization Review Accreditation Commission). URAC is limited to accrediting retail specialty pharmacies; however, both physician dispensing programs and closed-door retail programs are eligible for Specialty Pharmacy Accreditation through ACHC. In this article, we’ll outline the steps to successfully achieving ACHC accreditation.
5 Steps to ACHC accreditation
1. Establish your ACHC account
First, your practice will need to set up an account at ACHC Customer Central, which will serve as your home base to complete the accreditation process from start to finish. At ACHC Customer Central, you can complete an application, pay the application fee and meet your ACHC account advisor. Any application fee you submit will be applied towards your accreditation fee. VitalSource™ GPO members will receive a discount on their accreditation fee.
Some PBMs require you to be working towards accreditation in order to be “certified” to participate in their network. If this is your first time going through the accreditation process, you will want to ask for an “In Process” letter from ACHC as verification.
TIP: The VitalSource™ GPO Site of Care Dispensing Team is available to help you understand whether an “In Process” letter may be needed.
2. Review the Standards
The ACHC Specialty Pharmacy (SRX) Standards are divided into seven sections, each with its own focus. Here is a high-level overview of the intent of these sections, as well as some specific challenges and helpful tips.
Section 1 – Who are you?
This section examines your organizational structure—the governing body, ownership, bylaws, decision making authority, and, in general, who is a part of your business. Most practices have overarching policies and procedures and an organizational chart that meet these requirements. Ensuring that all applicable licenses needed are current and active is also an important part of this section of standards.
Section 2 – How do you operate?
The entire business, not just the pharmacy, is required to meet the standards in this section. Section 2 is concerned with how your practice handles ethical issues and any patient complaints or grievances. These standards address diversity, communications, and ensuring there is a toll-free number in place that can report on wait times and any dropped calls.
Section 3 – What is your financial outlook?
Physician practices are constantly reviewing expenses, revenue and margin to help ensure continued growth. Section 3 looks at how the dispensing program fits into the overall financial picture of the practice. Having a budget for the dispensing program and clear recordkeeping is an important part of this section. Monitoring of cash pricing, financial assistance, and general charges and billing processes will be required to meet these standards.
Section 4 – Is your staff trained?
Your practice’s human resources department and director must be on board with the accreditation process. ACHC surveyors will be required to meet with HR personnel, and have access to employee files to ensure the standards in this section are being met. Most standards in this section can be met by a thorough review of the “New Employee Orientation” process. Annual training, testing, competency, and other requirements can be reviewed during the annual “Performance Review” process for employees—ensuring that elements of these standards don’t get missed. Tuberculosis testing, Hepatitis B vaccination, and drug testing policies are key to passing the accreditation survey in this area.
Section 5 – Are you offering quality care?
This section is where your program—whether physician dispensing or closed-door retail pharmacy—is able to show the quality and consistency of care that is being provided. Surveyors will review patient records for content and retention. It is important to review the materials you are using to educate and inform patients about their medications and the information you are sharing with other healthcare providers. Communication to patients regarding the timeliness of delivery of their medications, both new and refills will also be reviewed. In this section, the concept of a patient “Plan of Care” is introduced. These plans of care are required to be initiated with the initial prescription, reviewed at least monthly, and involve patient interaction. Care plans may be manual or integrated into your software, but they must be in place for all patients on specialty medications.
TIP: For PioneerRx users, VitalSource™ GPO offers pharmacy care plans integrated within the software to help simplify these requirements.
Section 6 – How are you performing?
This section tends to be the most difficult and time-consuming for practices. In Section 6, the practice is asked to prepare a written “Performance Improvement Plan” outlining the elements that they commit to monitoring - in writing. Some of these elements include:
- Adverse events
- Patient complaints
- Patient record content
- Patient satisfaction surveys
- Billing and coding accuracy
Additional metrics may be added at the practice’s discretion. An annual report is required and must include a complete review of the dispensing program, including:
- Number of patients served
- Number of prescriptions dispensed
- Prescriptions per payor
- Delivery times
- Patient complaints
- Toll-free phone call metrics
- Satisfaction surveys
It is important to be specific regarding what is being monitored, where the data is coming from, who is responsible for pulling the data, how often the data is being pulled, the benchmark or goal you are striving for, and any action to be taken if that benchmark is not reached or that goal is not obtained. This section requires a lot of time and effort during initial accreditation, but also is an important part to keep running smoothly for the re-accreditation process.
Section 7 – Is your facility safe?
Section 7 looks back at the practice as a whole and ensures that the dispensing program and pharmacy staff are aware of policies and procedures that keep them safe while working. This section includes standards for an emergency preparedness plan, disaster training, fire safety and the handling of hazardous drugs. Storage of medications, medication recalls, and any REMS (Risk Evaluation and Mitigation Strategy) program policies and procedures will also be reviewed during the survey process.
TIP: Your VitalSource™ GPO Practice Consultant is here to help you review the standards, set up a project plan, provide site visits, and walk you through the entire accreditation process.
The Oncology Distinction (ONC): Section 11
Practices dispensing oral chemotherapy agents are also eligible for an Oncology Distinction (ONC). ONC standards focus on the specific needs of the cancer patient and how those needs are met. Obtaining this distinction enables you to obtain additional accreditation, which may be required by some pharmacy networks. The ONC is also an excellent way to demonstrate, and be recognized for, the quality of care you are providing for your patients
The requirements focus on the processes, policies, and operating procedures that make cancer care unique. You will be asked to form a “Professional Advisory Committee” that regularly meets to problem-solve issues related to patients receiving oral chemotherapy medications. Ongoing staff education in areas specific to cancer patients, is required. Ensuring that orders are initiated and reviewed by the physician and the dispensing program to ensure proper dosing and monitoring is key to meeting this distinction. Ensuring that financial assistance and patient advocacy support is provided to each patient is also a requirement, as is compliance with USP <800> standards pertaining to the dispensing of oral hazardous drugs.
TIP: Organize and add oral chemotherapy regimens to your EMR to help meet these standards.
3. Submit Your “Readiness Date”
After you have reviewed the standards of ACHC accreditation, you will need to submit a Preliminary Evidence Report (PER) to ACHC. This report is meant to prove to ACHC that your practice is prepared to comply with their standards as of the readiness date you submit. You will be asked to attest that you have the required policies and procedures in place, and you will be required to submit any necessary documentation.
TIP: When do you know you are ready? How will you know? Your VitalSource™ GPO Practice Consultant can assist you with timing of the submission of your Preliminary Evidence Report (PER) to ACHC.
4. Onsite review
After submission of your Preliminary Evidence Report, ACHC will contact you to schedule the survey date for onsite evaluation of your facility. You have the opportunity to request “black out” days –when key personnel are out of the office and not available—or holidays when the offices may not have required staff on site. If you do not have durable medical equipment as part of your dispensing process, you will know when the survey will occur. Your surveyor will be someone with extensive experience in the area of specialty pharmacy, likely a pharmacist with over 20 years of experience, but you will not know the name of your surveyor. They will spend at least a full day at the practice reviewing employee files, patient records, meeting minutes, and policies and procedures. In addition, they will observe, talk with staff, and even talk with patients. They will also ask to review the Performance Improvement Plan and ask questions. Staff should be well educated and be prepared to answer questions from the surveyor with confidence.
5. Plan of Correction
ACHC wants you to be successful in your pursuit of accreditation. Some deficiencies can be corrected while the surveyor is on site, while others will require submitting documents or statements. ACHC rarely requests a re-visit for proof of correction. Plans of Correction are submitted online and can be completed with the assistance of your Practice Consultant. When the plans of correction are received and accepted by ACHC…your practice receives accreditation. Accreditation is good for three years—at which time you will be re-surveyed to maintain your accreditation.
ACHC certification may seem complicated, but when you look at it step by step, it is as easy as Prepare (steps 1-3) and Certify (steps 4-5). Our Site of Care Dispensing team can assist with surveying your current challenges and our ACHC-certified Practice Consultants can assist you with creating a roadmap for addressing these standards.
With ACHC Accreditation discounts available, and a team of accreditation experts at your disposal, VitalSource™ GPO is here to help you every step of the way.
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