Quintin Jessee, PharmD

Vital information on the URAC accreditation process is presented that will help specialty pharmacies prepare. Watch for subsequent articles on the 5 main URAC specialty pharmacy modules of standards.

Although you may have not heard of URAC accreditation yet, it may just be a matter of time before it will either directly or indirectly affect you and your organization. URAC accreditation is growing in importance in the health care industry. It was recently announced that URAC was one of the 2 approved accreditations for health plans as part of the Patient Protection and Affordable Care Act (PPACA).

PPACA Section 1311 (c)(1)(D)(i) requires that all health plans offered through state insurance exchanges be accredited with respect to local performance:

		Clinical quality measures such as HEDIS

		Patient experience ratings on a standardized CAHPS survey

		Patient information programs by an entity recognized by the secretary for the accreditation of health insurance issuers or plans (so long as any such entity has transparent and rigorous methodological and scoring criteria)

So, how does this affect a specialty pharmacy? There are several managed care health plans that have recently mandated in RFPs that specialty pharmacies have URAC specialty pharmacy accreditation. This trend is growing throughout the United States, and if you don’t get prepared you could get locked out of some large managed care health plans—if you have not already been affected.

Managed care health plans are mandating URAC Specialty Pharmacy Accreditation for a couple of different reasons. One is due to the mandate for health plans to have URAC Health Plan Accreditation as part of the PPACA, as mentioned above. There are accreditation standards that are specific to contractors. If you are providing specialty pharmacy services, you will need to adhere to URAC standards as part of your contract agreement. It also helps align their standards for accreditation with the organizations that they partner with and aligns both quality goals and clinical oversight. Another reason health plans mandate URAC accreditation is that it helps to narrow their network of pharmacies. The accreditation helps them ensure that the partnerships they have with specialty pharmacies have solid third party validation of their operations. It also fosters continual improvement and regular updating of current best practices that help enhance operations and services.

Overview Of the URAC Accreditation Process

 Business signs agreement and pays accreditation fees.

 Business works on accreditation responses and provides documentation in relation to the standards.

 Accreditation body responds to documentation and entity has a determined time frame to respond to Requests for Information (RFIs).

 Accreditation body does an onsite audit of policies and procedures.

Once an accreditation is granted, there will be a periodic review of policies and procedures.

As mentioned, you will start by working with URAC and its business development team to determine the fees. The fees are based on your volume of specialty pharmacy claims. There are tiered pricing levels to help newer pharmacies get started. They even have a provisional accreditation category that will help assist brand-new start-up specialty pharmacies. It gives them a little more time to prepare for full accreditation than an existing pharmacy. If you are an existing specialty pharmacy, then you will undergo the normal URAC accreditation process. URAC will prepare an agreement that will need appropriate sign off and to be sent back with payment of the fees.

The next step is to do a GAP analysis and figure out what enhancements need to be implemented into your operations. All URAC accreditations are prescriptive in nature and not instructive. Basically this means that they won’t tell an organization how to manage a standard. They will verify that your P&P is being followed and that your staff is familiar with the P&P. You will need to compare your operational processes and policies with the URAC standards. As part of the accreditation fees, you will get a specialty pharmacy training session.

This training session is offered as either a live or an online WebEx-type training. You also get a quality summit meeting admission with your accreditation fees. One important note is that you want to take advantage of these training sessions early in the process or they could expire. You usually have approximately 6 months to get your documents and policies and procedures loaded into the Accreditnet tool. Another very important note is to make sure you provide clear citation information. This can help the desktop reviewer identify where the standards are met in your documents that are submitted. Being as specific as possible and highlighting the information is also helpful.

After everything is loaded into Accreditnet, URAC will perform a desktop review of what you have loaded. Basically, they are comparing your submissions with the standards for the accreditation. This process can take between 4 and 6 weeks, depending on how well you did providing information and documentation. After they get finished with the initial desktop review, they will come back with an RFI. This will be a process that will help you prepare for your upcoming on-site audit.

You will be asked to enhance your policies, submit more documentation, and correct any mistakes that were made during the initial submission. The process of responding to RFIs may take several times to complete. The first RFI submission time to respond is 30 days. Any subsequent RFI submissions will need to be responded to within 10 days. After you get this completed you will need to prep for the next step—the on-site audit.

The on-site audit will be scheduled with your organization. This will not be a surprise, because URAC wants to make sure your key people are available to be interviewed. URAC will provide you with an agenda for the on-site visit. The agenda will give you approximate time-frames on what will be taking place. Inspections are typically 1 day, but I have seen 2-day inspections. The agenda also has items that you will want to have prepared and available for the on-site audit. Basically, the inspectors will be verifying that you are operationally performing the standards and information in your policy and procedures. After the on-site audit, the inspectors will take the information back to a committee to review the findings and they will make a ruling on your accreditation.

		 If you have not received a copy of the Specialty Pharmacy Accreditation manual/guide, it can be accessed online by signing onto your URAC account at www.URAC.org. If you have any trouble you can also contact URAC at (202) 216- 9010.

		The Accreditnet online application tool will help you facilitate submission of your documentation. It is recommended that you either attend a free live webinar or watch a recorded webinar at www.urac .org/healthcare/accreditation/accreditnet .aspx. There is also an instruction booklet that can be downloaded to assist you.

		There are also several educational tools. They range from live seminars, webinars, and podcasts to manuals. Some of these educational materials are complimentary and some have fees. Here is the link to the URAC educational information: www .urac.org/accreditationEducation/. You will find a calendar of events and access to all the tools mentioned above.

		No longer have “primary” and “secondary” standard elements

		Distinct standard element weight categories 1 to 4

				      All elements must be fully met at 100%

		Lowest site score determines application score

		All module scores roll up into 1 total score		

				Other modules combined contribute to 70% of total

		Must meet all mandatory elements in order to achieve a FULL accreditation, regardless of total score (no change from previous policy)

		Must achieve a FULL accreditation in order to receive recognition in the Accreditation Summary Report (ASR)

		A “Leading Indicator” is a non-weighted, optional element—and acts as “extra credit”

Once accreditation is received, you will be monitored by URAC for compliance. There are 2 ways they monitor your compliance:

				Pharmacy will have to fill out an annual report to submit to URAC

				Any changes to key contacts and organizational structure need to be done ASAP and can be done in the Accreditnet application

				This is typically sparked by a complaint

				The event is announced (3- to 7-day notice)

				Will occur regardless of a reply from point of contact. This is one reason why any changes to staff or organization need to be updated in Accreditnet ASAP

				Will have a different reviewer from original survey/on-site inspection

				Scoring of the monitoring could change the accreditation status for the organization

Now that you have some good information on the overall URAC accreditation process, we will go a little deeper into the standards. There are 5 main URAC specialty pharmacy modules of standards. In subsequent editions of 

, we will dive a little deeper into each of these standards and modules to help explain what things you need to do in order to properly prepare for accreditation.

Quintin Jessee, PharmD, is director of specialty pharmacy consulting for D2 Pharma Consulting LLC and has more than 10 years of senior management experience in specialty pharmacy operations.

Articles

URAC Accreditation Update: Getting Prepared

Providing MTM services can be both rewarding and profitable.

	In today’s pharmacy practice, there are more financial pressures and focus on profitability. Whether it be the economy, decreased margins, brand name products becoming generic, or a variety of other challenges, how are you turning those challenges into opportunities? One great opportunity is adding medication therapy management (MTM) services to your business portfolio. MTM is becoming more and more popular— and if you don’t get into the game now, it might be too late.

	One of my college pharmacy professors, Dr. Peter Previte, explained to me that pharmacists need to be more entrepreneurial. When he started out in pharmacy, pharmacists were presented with the opportunity to add a new line of services to their portfolio. This was quite a few years ago, but the message still rings clear today.

	Back then, pharmacists were presented with the opportunity of adding hearing aid services to their pharmacy practices. However, the pharmacists at the time decided that this was not in their area of expertise, so they passed. Hearing aid services have been a fairly lucrative business model with franchises, and some of my non-pharmacist colleagues have been very successful. Likewise, MTM could be the next profitable opportunity for your business.

	The FDA and biotech pharmaceutical manufacturers mandate clinical programs such as MTM and Risk Evaluation and Mitigation Strategies (REMS). These new clinical programs can provide you with an opportunity to get access to products that you may not have had before when these mandates were not in place.

	In Ohio, for example, there is new legislation requiring managed care organizations to have MTM programs in place for their patient populations. If you are part of the solution for the managed care organizations, it could be an opportunity for you to be one of their providing pharmacies, and could create additional sources of revenue for your pharmacy.

	One of the realities that is also a positive factor in MTM services is the fact that new graduates are being trained and educated on MTM program management. So, you have qualified and trained personnel who can help manage your MTM programs and services. Not being an expert was a fear back when pharmacists were presented with adding hearing aid services to their business model. This fear is not a reality with MTM. Getting into MTM programs and services is not an opportunity that pharmacists should be passing up if they want to help keep their profession alive.

	The benefits to your business profitability of adding MTM services are numerous. Not only will you be building stronger relationships with your patients, you will also improve outcomes. By improving outcomes, you can compete for contracts if you have the right foundation built for MTM management. You can also be paid if you can report key data elements.

	If you have a system to help track the key data elements, it makes this solution less complicated and automated. If you have to do this manually, it can be done but it is labor intensive.

	When I managed my first MTM program, I managed the data elements we tracked on an Excel spreadsheet. However, now there are better solutions available to help automate the tracking of data. There are even successful proven clinical protocol solutions to help manage disease states such as diabetes, cholesterol, pain, and several others. This will require some investment up front; however, the return on investment can be short with the right MTM strategy.

	How long have pharmacists been doing MTM and just not getting paid? Answer: A long time! It’s time for us to seize this opportunity as a profession and as business owners to keep our profession alive and strong. If pharmacists seize opportunities such as MTM, we can find the solutions that will continue to improve patient outcomes while doing what we do best—helping patients understand and take their medication the correct way.

	Pharmacists can create win-win solutions for their patients and health care if we don’t let ourselves get in the way. I would highly recommend you do some serious thinking about the question, “Should I offer MTM services to my patients?”

Should I Offer This Service to My Patients?

The International Classification of Diseases codes will undergo significant changes to address the limitations of coding hospital inpatient procedures and patient medical conditions. Here's what you'll need to know to stay abreast. 

On October 1, 2013, significant changes to the International Classification of Diseases (ICD) codes will become effective. The current ICD-9 codes used to report inpatient procedures and diagnoses will be replaced by ICD-10 codes. To support this change transaction standards for electronic health care claims will be upgraded from Version 4010/4010A, to version 5010 by January 2012.

The transition to ICD-10 codes was primarily implemented to address the limitations with ICD-9 coding of hospital inpatient procedures and patient medical conditions. Most notably, ICD-9 coding contains outdated terms (30 years old) and is inconsistent with current medical practice. In addition, the ICD-9 categories have reached their intended capacity and therefore structurally limit the number of new codes that can be created.

For use in all inpatient US hospital settings. ICD-10 inpatient procedure codes utilize 7 alphanumeric digits instead of the 3 to 4 numeric digits used for ICD-9-CM coding. As a result, the ICD-10-PCS coding is more specific and substantially different from the ICD-9-CM coding.

For use in all US health care settings, ICD-10 diagnosis cose utilize 3 to 7 digits instead of the 3 to 5 digits used for ICD-9-CM coding. The ICD-10-CM code set formats are similar to ICD-9-PCS coding.

The ICD-10 transition will not just affect those who submit Medicare or Medicaid claims, it will affect diagnosis and inpatient procedure coding for all covered entities governed by the Health Insurance Portability and Accountability Act (HIPAA).

Covered entities governed by HIPAA who transmit electronic claims must also abide by Version 5010 transaction standards. The change to ICD-10 does not affect CPT coding for outpatient procedures. Covered entities must be prepared to comply with the Version 5010 and ICD-10 transitions, which means:

		Health care providers, payers, billing services, clearinghouses, and other organizations that conduct electronic transactions should have completed internal testing of Version 5010 systems in time to begin external testing with one another by 

		All electronic claims submitted on or after 

, must use Version 5010 transaction standards. Electronic claims that do not use Version 5010 standards will not be paid.

		ICD-10 diagnosis codes must be used for all health care services provided in the United States on or after 

 ICD-10 procedure codes must be used for all hospital inpatient procedures performed on or after 

. Claims with ICD-9 codes for services provided on or after October 1, 2013, will not be paid.

It is important that you prepare for the ICD-10 and Version 5010 transition as soon as possible. Here are some tasks to help you get started:

		Payers need to review the new coding rules for ICD-10 for payment. Start by asking your software vendors about the timelines for product development, readiness plans, testing, training, and availability for ICD-10 and version 5010 transitions. It would also be prudent to develop a strategic plan as well as a budget dedicated to transition preparations.

		Providers need to also prepare an implementation strategy that includes an assessment of the impact to their organization. Ensure that you are aware of and have accounted for all direct and indirect requirements associated with your clearinghouse, billing services, and practice management software vendors ICD-10 transition, plans. If you handle your own billing and software development, then you will need to create and implemente strategy and plan unique to your operations.

		Software vendors, third party billing services, and clearinghouses should have development in place for services and products that will allow their clients (payers and providers) to fully implement Version 5010 transactions by 

		Similar to Y2K, organizations will need to proactively identify all ICD-9 codes currently present in each of their current systems in order to systematically determine the impact of the conversion. This will assist in defining the proper conversation mapping(s) necessary to support a successful conversion.

		Organizations will need to assess the impact of conversion on historical records within each system. Special considerations include code conversion to support billing for adjustments on past claims, maintaining the code conversion records per transaction for balancing purposes, and the impact to current reporting requirements.

		If claims are submitted via any paper forms, it may be necessary to support the impact of code conversion for paper claims transactions. Changes may include subtle formatting and spacing changes. Be careful!

		Organizations should proactively verify the readiness of their partners. Data exchanges to and from pharmacies should be tested to ensure minimum impact to operations post conversion.

VERSION 5010 AND ICD-10 SOURCE INFORMATION 

The Centers for Medicare & Medicaid Services (CMS) website is (

) provides resources to help you prepare for Version 5010 and ICD-10. CMS will continue to add new tools and information to the site throughout the course of the transition, so be sure to check the site frequently for updated resources.

There are also several professional, clinical, and trade associations offering a wide variety of Version 5010 and ICD-10 educational resources, information, and checklists. Call or check websites of your associations and other industry groups to see what resources are available. 

Quintin Jessee, PharmD, is director specialty pharmacy consulting for D2 Pharma Consulting LLC and has more than 10 years of senior management experience in specialty pharmacy operations.

Jim Maguire is the chief executive officer of BioMed Intelligence, Inc, a firm specializing in health care information technology support solutions. With more than 20 years of experience, Mr. Maguire was formerly the chief information officer of a top pharmacy benefit manager and also led information technology operations at a top specialty pharmacy. Contact Mr. Maguire at (347)847-357; jmaguire@biomed-intelligence.com or 