Innova 340B Solutions

Innova 340B Solutions offers a suite of products, coupled with the internal knowledge and expertise of industry experts, designed to perfectly meet the needs of an entity in any stage of 340B Program Administration.

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The Trump Administration and the Impact on the 340B Drug Program

Posted on February 1, 2017 by Bob Brown

The 340B Drug Program may encounter some changes due to the new administration and Republican congress. Some assume that drug manufacturers interests will be attended to rather than the concerns of health plans or providers. Whether or not this is true has yet to be shown. Prior to the new administration's shift into office, the 340B mega-guidance was sent for evaluation under the current administration. Due to the change in power, analysts are standing by to see if this guidance will be repealed or upheld.

In addition, questions are being posed about HRSA's authority to regulate the guidance apart from congressional oversight. Historically, PhRMA has filed suit against them and court rulings have conflicted in independent cases. The 340B drug program could most likely see a number or legal challenges as the administration takes form. New criteria could be introduced but it is uncertain at this time.

Provider Eligibility Increase

Originally, the 340B Drug Program provided outpatient drug discounts from drug manufacturers to a host of providers and programs. In 1992, 340B covered almost 800 hospital outpatient locations around the country. As time has gone by, the number of eligible providers has jumped to over 28,000. This was due in part to the ACA, which extended the program to a number of hospitals and locations.

Amongst Republicans, the 340B Program is thought to have grown larger than it was originally designed to be. Strategies to decrease its size are evident within the CURES Act. For instance, critics are saying that 340B eligibility should return to its original qualifying criteria from 1992, which defined eligibility as a safety net provider serving large numbers of uninsured and underinsured patients. This provision was removed due to push back from 340B eligible providers in their districts.

Patient Eligibility

In addition to provider eligibility, the patient eligibility for discount drugs has also been an issue of debate. The 340B statute establishes that a covered entity should not resell or otherwise transfer a drug to a person who is not a patient of the entity. Where things get difficult is in regards to what qualifies as a patient of an entity. Some believe that the 340B program was developed for all patients regardless of their health coverage and others believe it was restricted to those who do not have the capacity to pay.

Congress could attempt to change eligibility in a number of ways. It could be proposed that providers can only claim a drug discount if the covered entity writes the prescription at the time of the patient's visit to a qualified hospital. Alternatively, proposals could limit eligible prescribers employed by covered entities or an "eligible patient criteria" would require multiple interactions or visits to an eligible provider. Regardless of the legislation, regulation, or guidance, most Republicans are focused on making the drug discounts available exclusively to indigent patients of a 340B covered entity.

Child Site Eligibility

The new administration may also limit the number of Child Sites. As of 2015, CMS is obligated to reimburse a number of hospital off-site outpatient services at the physician fee schedule rate. They suggested that in order to do this reimbursement, services would be classified as physician services, not as hospital outpatient services. However, due to regulations, off-campus outpatient services were still qualified for 340B discounts. This could be another component repealed by Congress or the new administration.

Contract Pharmacies

Contract pharmacies are pharmacies under contract with 340B Covered Entities to dispense 340B program covered drugs. Since 1992, the number of 340B program contract pharmacies has increased by 770%. The Office of the Inspector General found that contract pharmacy agreements have led to 340B drug discounts being claimed for patients or prescriptions that were not eligible in some scenarios. Many critics of contract pharmacies, including Members of Congress, feel that contract pharmacies take some share of the financial benefit of the 340B program discount inappropriately. It is very likely that the new administration and/or Congress will seek to restrict the role of contract pharmacies by, for example, returning to HRSA's initial guidance related to contract pharmacies that reduced the number of contract pharmacies and imposed geographic limitations.

Duplicate Discounts-- 340B Drug Program and Medicaid

When a 340B covered entity claims a discount on a prescription and the state also claims a Medicaid rebate for the same prescription, drug manufacturers are supplying duplicate discounts on the exact same medication. In addition, CMS has required States to claim Medicaid rebates for all prescriptions dispensed to Medicaid patients, which saves the Government. The duplicate discounts are incredibly complicated to track. It is expected that manufacturers and Congress will highlight this problem to scaling back or eliminating the 340B Drug Discount Program.

Conclusion

The future of the 340B Drug Program is uncertain as it continues to be assessed and the new administration shifts into office. Critics are divided and feel that it may be repealed or scaled back. It will surely be interesting to watch as the dialogue continues to evolve.

Discover more here. 

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Get Ready for A HRSA 340B Program Audit

If your covered entity ("CE") has not experienced a HRSA review yet, it is coming to you sometime soon. Many CEs have previously experienced the Health Resources and Services Administration ("HRSA") audit procedure.

Audit Fundamentals

There are two reasons a CE gets audited: (1) someone alleges violations of the 340B Drug Pricing Program ("340B Program") (termed "targeted audits") or (2) the CE's system possesses qualities that make its 340B program more complicated (termed "risk-based audits"). The audit process has three steps. First is the pre-audit, where HRSA supplies the CE notice and requests data. About four to eight weeks later, the HRSA auditor comes onsite to actually carry out the audit. Sadly, at the end of the onsite audit, the auditor is restricted from disclosing the audit discoveries. Third, and lastly, post-audit results are shared with the CE. Apexus states the audit findings will be sent within 30 to 90 days, but that did not appear to be the experience that most CE's had.

Audit Finding Trends The three most frequent audit discoveries relate to the following: - Incorrect 340B Database Records - Diversion. - Duplicate Discounts. HRSA has been dinging CEs who have not kept their Medicaid Exclusion File information current. Around half of all diversion discoveries related to contract pharmacies.

If You Have Any Grounds to Object to the Audit Findings-- Do It!

As soon as the CE receives the audit findings, the CE should carefully review them. CEs have 30 days to dispute the findings with supporting documentation. If anything seems to be off, or not quite right, or misunderstood, contest the findings. The support of experienced counsel can be vital in this process. Approximately 50 percent of the CEs that dispute audit findings are successful in overturning one or more findings.

If a CE finds itself in total agreement with the findings and chooses not to contest, the CE has 60-days to provide a corrective action plan ("CAP"). If the 60-day deadline is blown, the CE risks termination from the 340B Program. A CAP exhibits to HRSA that the CE takes the audit findings seriously and outlines the immediate steps that will be taken to correct the discoveries. Once the CAP is approved, the CE is required to prepare a mea culpaletter, which will be put up on the HRSA webpage, along with a summary of the CAP. CEs that are mandated to repay manufacturers are subject to a follow-up audit within a year.

Read more here.

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340B Drug Pricing Program 'Mega Guidance'-- Key Takeaways

Posted by Bob Brown

HRSA has released guidance on the 340B drug pricing program. The guidance will more than likely be issued in the Federal Register late summer. While the guidance addresses a range of issues, it will most likely focus on the definition of patient, contract pharmacy compliance requirements, hospital eligibility criteria and qualifications of off-site outpatient locations.

340B Drug Pricing Program Covered Entities

All off-site outpatient facilities and clinics not located at the same physical address as the parent hospital facility will be shown on the public 340B database. Off-site outpatient clinics are able to purchase and use 340B medications under the following two conditions:

Each clinic is listed on a line of the cost report that is reimbursable under Medicare The care provided at the facility has associated outpatient Medicare costs and charges

340B Patient Eligibility

Individuals who are not patients of a covered entity are not eligible to receive drugs bought through the pharmaceutical discount program. An individual must match the following criteria to be regarded as a 340B patient:

The individual receives a healthcare service at a facility enrolled and listed in the 340B Program.

A covered entity service provider can provide services to an individual when the provider is employed by the covered facility or is an independent contractor for the covered facility.

An individual receives a drug that is prescribed by the covered facility provider as a result of the services specified mentioned above.

The individual's healthcare must be consistent with the service or assortment of services designated in the federal grant, project, designation or contract.

Medications are purchased or prescribed pursuant to a healthcare service that is categorized as outpatient.

Patient records are managed by the covered entity and demonstrate that the covered entity is responsible for care.

Re-enrollment

Covered facilities removed from the system due to qualification guideline violations would be able to re-enroll during the next regular enrollment time after it had complied with all HHS statutory criteria and offered payment to affected manufacturers, if necessary.

GPO Restriction

We expect that HHS will define in its guidance the group purchasing organization prohibition for certain covered facilities. Off-site outpatient entities, which are not listed on the public 340B database will be able to access outpatient drugs through a GPO presuming the facility has a buying account separate from that of any 340B enrolled facility. Drugs acquired through GPO can never be supplied to outpatients of the hospital or other care locations enrolled in the program.

Exemptions

Hospitals may use GPO's when a drug can not be accessed at the 340B price or at wholesale acquisition cost to prevent disturbances in patient treatment. Certified hospitals that use a GPO for covered outpatient drugs in these circumstances must document the information surrounding the acquisition and provide records to HHS.

Routine maintenance of 340B Drug Discount Program Records

HHS is thinking about establishing a standard time interval for record retention. The Standard would attempt to balance the need for a covered facility to document compliance with program criteria with the effort and expense required to maintain records for any extensive period of time.

Statutory Requirements and Compliance

HHS is introducing compliance systems for covered entities that contract with pharmacies to dispense 340B priced drugs. Covered should take the opportunity to evaluate and reconcile pertinent 340B drug pricing program patient eligibility status through periodic audits and review of contracted pharmacy functions. We propose that Covered Facilities should compare prescribing records with the contracted pharmacy records every 3 months.

Referral for services for Specialty Services

The propositioned guidance indicates that this place of practice will be very minimal, if proposed language is adopted without considerable modifications. Entities should give careful consideration to future use of referrals and the related records of such services in the patient's medical record. In the current state, any referral should be recorded in the record as well as proof of the subsequent care plan or treatment plan. Additionally, the Entity should ensure the Primary care service provider accepts the report or plan and is assuming responsibility for any care given pursuant to the plan.

Key to Being Compliant

All 340B drug pricing program -qualified beneficiaries or other eligible facilities should be creating action plans to respond to the final presented guidance with a goal to achieve and maintain a compliant program.

Learn more here!

Posted in 340B ProgramTagged with: 340b drug pricing, 340b program, hrsa, innova 340b solutions

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Complying to 340B Program Mega Guidance

By: Bob Brown

Covered entities waiting for publication of HRSA's mega-guidance should get ready to be compliant with the 340B program on the effective date of new guidance. Entities will need to evaluate its compliance with the latest rules and incorporate processes that support a compliant program in the new environment. The following strategy offers a simple view of how to act now for future program modifications, if needed.

Step 1: Assessing Your 340B Program

Entities need to determine at risk parts of their 340B program and need to make necessary policy modifications and process improvements in order to be compliant. Entities need to be aware of problems, how to address them and designate staff to take care of them so that the program is compliant. The following are categories and inquiries to consider:

Patient eligibility: Are patient eligibility requirements adequate and defensible? Who are the individuals who will need to implement the necessary changes? Auditing and monitoring: What are the processes and have they been effective? What are the outcomes and have non-compliant findings been addressed ? Accumulator and splitter software: Is software configured correctly to facilitate the program, recognize qualifying dispensed drugs and capture and store records? What settings need to be focused on to ensure compliance? Oversight and governance: Is a multidisciplinary committee in place to review important components of the program such as documentation and software updates on a regularly planned basis?

Step 2: Anticipating-- How will the program appear structurally, operationally, and financially?

A a large number of covered entities are not structured to accommodate specific new proposed restrictions, such as stringent MCO pharmacy eligibility criteria and exclusions from the HRSA guidance.

For instance, the revised definition of a patient as an individual billed as an outpatient to their insurance or third-party payer could impact system configuration, documentation and program savings. Quantifying the impact of these changes using analytics will aid organizations in preparing for the financial and operational impact of HRSA's proposals. The additional restrictive language regarding referrals will certainly have an immediate impact on access to care, in some instances.

The proposed guidance is going to require covered entities to address how the following changes will influence their 340B Drug Programs:

340B drug discounts in the contract pharmacy setting may significantly decrease the volume of subsequent savings and qualified 340B dispensations. The requirement to bill on behalf of participating service providers may shorten the list of qualified providers. Discharge prescriptions linked to inpatient stays would no longer qualify for 340B replenishment.

Step 3: Capitalizing on Opportunities

Lastly, it is advised that covered entities carry out a full review of their methods, which will highlight opportunities for improved efficiency and enhancement. Assuring programs function efficiently and effectively will simplify the steps required to align with future regulatory changes.

The 340B Program has been under significantly more intense review over the past few years. Entities should monitor the published findings from audits and use the information to identify and assess known high risk areas within their operations. By continuous attentiveness, any Entity will be able to attend to possible problems, take corrective action and avoid findings of program non-compliance in the future. Proactive steps of assessing, anticipating and capitalizing will ensure success in the altered 340B environment.

Lean more here.

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About Innova 340B Solutions

Most entities offering 340B fall into one of three categories:

(1) We’re ready to implement a 340B Program and aren’t sure where to start.

(2) We have an established 340B Program, but are worried about compliance.

(3) We’re confident in the policies and procedures that we have in place for 340B, but could use a second look.

Innova 340B offers a suite of products, coupled with the internal knowledge and expertise of industry experts, designed to perfectly meet the needs of an entity in any stage of 340B Program Administration.

Our staff includes personnel in every department and at every level with direct entity expertise; first-hand knowledge of development, daily operations, and auditing of 340B Covered Entity Programs means our insight is not based on theoretical concepts and what-ifs. Our operations, solutions, and procedures are based on actual experience, with a team of pharmacists, attorneys, IT personnel and compliance officers who have each successfully operated a 340B program and/or been involved directly with HRSA on-site audits.  We are not an organization that has an ancillary 340B department or provides audit services as an additional option; as Innova’s only business line, our effort and research are specifically dedicated to 340B audits. Every entity benefits from the up-to-date knowledge and experience that can only be attained when 340B is your only business.

Our goals extend far beyond providing you with generalized templates or suggestions.  Our focus, instead, is on establishing a true partnership with your organization.  We never propose a ‘one-size-fits-all’ solution. Instead, our experience allows us to continually develop and modify best practices in 340B Program Administration for each individual client.  Your dedicated Innova support team works to understand your patient centric program (or develop a new program based on your needs) and will create a unique and individually-designed plan of action based on each covered entity’s requirements.  Our ultimate goal is to instill confidence and security that your program is compliant.

Our company is lead by 100+ combined years of 340B, entity and government program experience; Innova’s staff brings historical excellence in  340B advising services and audit services, 340B program implementation, Medicaid adherence reviews and support, Federally Qualified Health Center (FQHC) pharmacy leadership and major hospital oversight.  Innova’s services are recognized by the counsel for National Association of Community Health Centers (NACHC).