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340B Report’s Expert Tip series includes valuable tips from our impressive roster of sponsors. The tips are intended to help 340B providers be more efficient, reduce costs, increase savings, and improve patient care. The tips are also another way for our readers to connect with and get to know our great sponsors. We encourage you to check out the tips below!


Expert Tip from Maxor

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TIP: Improve capture rates to reach your full 340B savings potential.


From changing compliance mandates to the manufacturer restrictions that began in 2020 that limit access to contract pharmacy arrangements, covered entities are faced with increasing complexity when it comes to administering a successful 340B program and reaching their full 340B savings potential.

It’s more important than ever to identify opportunities to optimize your 340B program performance. Tracking and increasing capture rates is one best practice that can help ensure both financial and operational optimization.

A great place to start is with an in-depth analysis of your organization’s 340B eligible prescriptions to understand current patient and employee capture rates.

Here are three ways you can facilitate engagement and increase capture rates in your covered entity:

  1. Explore ways for employees to utilize the services provided in your organization. This could look like reducing co-pays for medical services, reducing prescription co-pays at your in-house pharmacy, or offering medication management services and point of care testing to employees. We’ve also seen organizations offer payroll deductions at their in-house pharmacies to support their staff with a seamless, contactless pharmacy experience.
  2. Consider new ways of engaging patients. Integrating pharmacists into multidisciplinary care teams can drive patient engagement. Monitoring medication adherence and tracking the therapeutic effects of medications can improve the quality of care and clinical outcomes.
  3. Explore a home or office delivery service. Convenient fulfillment options could play a large part in increasing capture rates. Offering a home or office delivery service can reduce wait times and promote adherence as patients can receive their medications and additional refills without having to visit the pharmacy.

Partnering for success

As the 340B landscape continues to evolve, the right partner can help you navigate the changes and complexity.

At Maxor, we help covered entities maximize 340B savings and unlock pharmacy value. We are a partner who supports your mission as you deliver vital healthcare services in your community.

Learn how our expert team can help optimize your 340B program and grow your specialty pharmacy with a comprehensive data assessment.

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Expert Tip from Cervey

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TIP: Don’t leave money on the table. Referral capture provides a unique opportunity to maximize savings for your 340B program, but it’s essential to ensure accurate referral validation through automated tools, industry expertise and clear, compliant protocols.


Referral capture offers a unique opportunity to maximize savings within your 340B program. Automated tools offer a streamlined approach to referral identification. However, it’s important to not stop at automation. Validation of referral opportunities can be a heavy lift on your 340B team – especially if you are already under-resourced.

By partnering with a solution offering validation in addition to identifying referral opportunities, you can reduce the margin of error and ensure that only eligible prescriptions are included. When defining an eligible referral prescription with your referral capture partner, incorporate 340B consultants, steering committees and any compliance teams that support the covered entity to be a part of the decision-making process. This is a critical step to balance the potential for increased 340B access while not sacrificing compliance.

Clear protocols are essential for maintaining consistency and accuracy in the referral validation process. These protocols should outline the steps for validating referrals, including the criteria for patient eligibility and prescription verification, to ensure thorough and comprehensive validation practices.

By prioritizing accurate referral validation through automated tools, industry expertise, and clear protocols, covered entities can maximize savings – and ultimately improve patient care.

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Expert Tip from Apexus

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TIP: Want to resolve negative 340B accumulations to improve your organization’s 340B compliance? Simplify your process for refunding manufacturers with the Apexus Covered Entity Refund Service (CRS).


Ineligible 340B purchases result from various situations, such as reversed claims, errors in eligibility data transmitted to 340B vendors, or inadvertent 340B purchases without supporting eligibility or accumulations. These errors may occur as a part of normal business practices. Even though most issues may not meet a material breach threshold requiring disclosure to HRSA, HRSA still expects noncompliance associated with diversion and duplicate discounts to be resolved with the manufacturer through repayment.

If ineligible purchases are identified early, there may be options to work with your wholesaler to return or credit and rebill the product. The credit-and-rebill process is typically restricted to within 3–6 months of the date of purchase; returns may have even shorter timeframes. Unfortunately, these solutions are not available for some products and cannot be used when the ineligible purchase was made prior to the respective timeframe restriction, such as more than 6 months ago. These situations typically require repaying manufacturers directly to ensure transparency.

Simplify the repayment process with CRS

Covered entities work with CRS to efficiently process repayments to manufacturers through a proprietary process, reducing time and effort spent correcting ineligible 340B purchases. Our experienced team ensures accurate repayment calculations and offers refunds to manufacturers on your behalf. With an average manufacturer response rate of 95%, CRS reduces the risk of nonresponsive manufacturers contacting you months after your repayment offer, so you can stay focused on your current work. CRS delivers a fully auditable report, providing transparency and peace of mind.

To sign up for CRS or learn more, visit https://www.apexus.com/apexus-refund-services/covered-entity-refund-service

 

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Expert Tip from Sectyr, LLC

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TIP: Make transparency and visibility the cornerstones of your 340B program.


As manufacturers continue to impose restrictions and covered entities struggle with rising costs, it is imperative to protect your 340B program. The best way to do this is to create transparency and visibility to other stakeholders in the organization. While 340B is something that is on the forefront of our minds, it might surprise you to know that we have had conversations with hospital leadership outside of pharmacy who had no idea of their annual drug savings and the impact of a manufacturer payback requirement or program termination.

Interestingly, when executives understand the value and consequences of non-compliance, they often become champions of the program in their facilities. Providing data around the annual program benefit, resource needs with maintaining compliance, community benefit, and current status can help a program leader be successful.

Providing the right level of information and education can help you:

  • Enlist other 340B champions
  • Gain resources
  • Quantify risks
  • Identify savings opportunities

In order to achieve sustainable compliance programs, executives must ensure sufficient resources are devoted to people, processes and technology. Technology tools, like smart auditing and guided workflows, can enable efficient use of resources to protect both program benefits and the covered entity’s bottom line. Ultimately it is making sure that leadership knows the value of the program, what it takes to be successful, and the consequences of non-compliance.

Sectyr has this information readily available. We provide a single source of visibility into 340B compliance status and our software solution serves as a hub for collaboration between your team and your auditors before, during and after an audit. Learn more here.

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Expert Tip from Ravin Consultants

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TIP: Expand your Ryan White 340B designation to include STDs to improve patient health outcomes and maximize your 340B savings.


Many Ryan White entities are not aware that they may already be eligible as an STD grantee for the 340B program. There are several benefits to utilizing an STD designation over a Ryan White designation, including:

  • Expanded patient care: With an STD designation, you can align more closely with your mission to ensure your at-risk patients stay safe and healthy from a broader set of diseases and infections.
  • Ability to serve more patients: By converting to a 340B STD Designation, your patient eligibility definition is expanded, extending your organization’s patient reach and increasing 340B generated revenue. Unlike the Ryan White 340B designation, which mostly captures HIV-positive patients, an STD designation allows you to capture patients with conditions such as Hepatitis C and individuals at risk of acquiring an STD, including those on PrEP.
  • Unrestricted use of 340B savings: Ryan White primarily covers HIV-positive patients, while an STD designation provides the flexibility to generate savings and allocate funds as needed within your organization and local community.  The STD designation allows you to provide the best care possible, including, but not limited to, expanding existing clinical and social-support services, curating new unfunded programming and activities, and supplementing administrative/salary expenses.
  • Less reporting requirements: It is critical to be a good steward of the 340B program and remain compliant. Transitioning to an STD designation reduces reporting obligations and can make it easier to do so. With a Ryan White designation, extensive budgeting and expenditure plans are required. Additionally, since the Ryan White program is payor of last resort, excess Ryan White Grant funds may need to be repaid to your Grant Administrator if your organization is unable to expend the grant funds after all 340B program revenue is spent.

Ryan White entities are not automatically eligible for an STD designation. In some instances, you may need to collaborate with your local government to secure additional grants or in-kind service contracts. If you have questions about converting your Ryan White designation to include STDs or need assistance liaising with local government officials, contact Ravin Consultants at info@ravinconsultants.com.

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Expert Tip From CPS Solutions

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TIP: Ensure your organization complies with the new 340B billing modifier requirements effective in 2024 and 2025.


CMS Changes 340B Modifier Requirements for Part B Drugs

CMS has made incremental changes to the 340B billing modifier requirement. Although compliance with Medicare Part B billing falls outside of a HRSA audit scope, it is important that all covered entities remain compliant with those guidelines. Pharmacy leaders and 340B coordinators are well positioned to identify any 340B-specific billing discrepancies and can assist with routine auditing after billing changes are implemented.

CMS 340B Billing Modifier Changes

The updated CMS billing guidance, which went into effect January 1, 2024, requires all providers and suppliers billing Medicare Part B for status indicator “K” 340B drugs to use the “JG” or “TB” modifier.

Considerations:

  • Previously, it was optional for critical access hospitals (CAH) to utilize the “TB” modifier for status indicator “K” 340B drugs. It is now mandatory for CAHs to submit the “TB” modifier.
  • 340B covered entities not previously reporting a modifier, such as grantees, should report the “JG” modifier when billing Medicare Part B for status indicator “K” 340B drugs.
  • Providers and suppliers, such as contract pharmacies, should submit the “JG” modifier when billing Medicare Part B for status indicator “K” 340B drugs.

Starting January 1, 2025, all 340B covered entities must transition to the “TB” modifier on 340B claims for separately payable Medicare Part B drugs and biologics. Covered entities also have the option for early transition to the “TB” modifier in CY24.

A complete list of drugs with status indicators is available on the CMS website under the most recent Addendum B file, which is updated each calendar quarter.

Additional information can be found in the following resource: Medicare 340B Billing Changes

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Expert Tip from Visante

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TIP: Make sure your 340B team is highly trained and adequately staffed.


Take advantage of any and all training provided by TPA vendors for new staff. These training sessions are typically at no cost to the Covered Entity.  Several TPA vendors offer videos embedded in their platforms that your staff can review when it is convenient.  In addition, many provide webinars as new functionality is released.

Encourage attendance at webinars and conferences to allow your staff to network and learn from experts in the 340B field.  This is critical for ongoing collaboration with other stakeholders and to develop a network of program support resources.

Investigate the Apexus Advanced 340B Operations Certificate program to provide your staff with a comprehensive overview of the 340B program.  Many covered entities cover the cost of the program to ensure their 340B team has a strong foundation. Apexus also provides educational offerings at no cost covering more focused topics. These are great ways to ensure you are up-to-date in all things 340B.

Many covered entities struggle to properly staff their 340B team and this is becoming a greater challenge with our current competitive labor market. It is not always possible to find qualified candidates. Whether you have a growing program in need of resources or face an unexpected staffing shortage, identifying a partner to work alongside your team to fill in the gaps short-term or long-term is an important part of planning. We suggest making sure you have highly trained resources, like Visante, lined up in case you need them quickly.

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Expert Tip from RxStrategies

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TIP: Maximize the effectiveness of your 340B program through consistent internal audits, ensuring both compliance and enhanced savings.


Establishing and running an effective 340B program requires diligent oversight and dedicated compliance management. A key component in achieving success is the regular implementation of internal audits. These audits serve as a proactive measure, ensuring your organization’s adherence to all the necessary regulations and guidelines governing the 340B program. By routinely reviewing your program’s operations, you can promptly identify and address any potential compliance issues, preventing their escalation into more significant problems. This not only helps in avoiding potential fines and penalties but also ensures that your program is operating at its full potential.

In addition to ensuring compliance, internal audits can also help optimize savings within your 340B program. A thorough examination of your purchasing and dispensing practices allows for the identification of opportunities to enhance efficiency and reduce costs. This could include streamlining inventory management, negotiating more favorable pricing with suppliers, or uncovering possibilities to expand the program’s reach to serve more eligible patients. By implementing adjustments based on insights gained from internal audits, you can strengthen the financial sustainability of your 340B program. This also ensures its continued provision of essential services to underserved populations while maintaining compliance with all relevant regulations and guidelines.

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Expert Tip From 340Best

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TIP: Create and maintain a comprehensive crosswalk or log documenting your 340B registered sites, contract pharmacies, and all associated contract pharmacy agreements.


Keeping a strategic log of essential 340B data elements is crucial for preserving your 340B eligibility. Regularly update your log with any new 340B contracts, clearly specifying the applicable sites (340B IDs) for each. This practice ensures efficient confirmation of registration accuracy, especially during quarterly internal or external audits. To streamline this process, consider leveraging the OPAIS database and incorporating additional fields for enhanced tracking.

Focus on key information to ensure effective oversight:

          1. Covered Entity Information:

    • 340B ID
    • Name and Address
    • Sub-Division Name

Why: Enables swift confirmation of accurate registration during audits and compliance assessments.

          2. Contract Pharmacy Information:

    • Pharmacy Name and Address
    • Pharmacy ID

Why: Essential for monitoring contract pharmacy relationships and ensuring compliance with 340B program requirements.

          3. Contract Information:

    • Contract Document Name and Location
    • Contract Begin and End Dates
    • Contract Approval and/or Termination Date (OPAIS)

Why: Facilitates effective contract management, ensuring timely renewals and adherence to approval timelines.

          4. Contract Pharmacy Rep Information:

    • Rep Name and Contact Details

Why: Streamlines communication and oversight of contract pharmacy relationships.

By focusing on these key data points, you enhance your ability to navigate audits, manage contracts efficiently, and maintain compliance with 340B program regulations.

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Expert Tip from Apexus

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TIP: When offering repayment to manufacturers for noncompliant purchases, it helps to standardize the refund process by setting a target date for completion, maintaining detailed records, and developing an action plan for manufacturers that respond after the target date.


Understanding HRSA’s expected timeline for manufacturer repayments resulting from self-disclosures and/or HRSA audit findings offers a model timeline that can be used for repayments that do not involve HRSA, such as for noncompliant purchases identified during self-audits that do not meet the organization’s material breach threshold. HRSA expects corrective actions plans (CAPs) from self-disclosures and OPA audits to be completed within a six-month timeframe. During the six months, entities determine the full scope of the issue, correct it, and offer repayments to affected manufacturers, providing periodic progress reports along the way. Once the CAP is fully implemented, covered entities deliver a final report indicating how the issues were resolved and how they will work toward repayment with manufacturers in the future for any issues that had not been resolved at the end of the six months.

Given these expectations, a few themes emerge that can be applied to all instances of repayment:

  1. Set a target date to complete manufacturer repayments.
  2. Maintain records of repayment amounts and outreach attempts to monitor progress.
  3. Develop an action plan to work with manufacturers that respond after the target date.

Completing manufacturer repayments accurately and efficiently can be challenging for the following reasons:

  • Historical drug pricing information may be difficult to access.
  • Manufacturer refund contacts are often not publicly available.
  • No statutorily defined process governs refunds of ineligible 340B discounts.

Refunding multiple manufacturers can be challenging to administer without appropriate resources.

Streamline the Refund Process: A Solution from Apexus

The Apexus Covered Entity Refund Service (CRS) helps covered entities streamline the refund process for noncompliance issues by:

  • Ensuring accuracy
  • Saving time
  • Increasing efficiency
  • Delivering auditable records

Apexus CRS draws on the expertise of Apexus in 340B compliance, transaction analysis, project management, and reporting to provide refund calculation, documentation, and closure.

To initiate a refund or prepare your organization for future refunds, visit Apexus.com/CRS, contact CoveredEntityRefunds@apexus.com, or call 888.340.2787.

 

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