Outpatient Pharmaceuticals

340B Compliance and Program Optimization

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Overview

Murer Consultants has a proven track record of enhancing health system pharmacy operations, including inpatient and retail pharmacy settings. Murer reviews pharmaceutical operations to identify opportunities for care improvement, administrative efficiencies, and improved workflow. Murer’s overall objective is to deliver an ongoing benefit to the healthcare organization’s bottom line. Murer’s approach is unique in that it includes a review of pharmacy and therapeutic strategies, utilization of high-cost drugs, formulary management, overall operations, 340B program, infusion and oncology services, and more.

Murer is a national leader in 340B compliance requirements and program optimization.  Although Murer’s consultants are primarily attorneys by training, our staff also includes pharmacists, pharm techs, nurses, physicians and accountants. Murer’s 340B services stretch across all aspects of the 340B program, including external auditing, HRSA audit support, contract/specialty pharmacy development, financial impact analysis, strategic development, compliance review, software implementation, staff training, and more. Our consulting is rooted in the 340B regulations and is informed by HRSA/OPA guidance as well as our vast 340B experience. Our direct HRSA experience, on-site audit time, and longevity working with the 340B program are second to none.

Murer’s Experience With 340B Programs

Murer has extensive experience assisting clients with many aspects of the 340B program, including the enrollment and auditing processes. Murer assists 340B-covered entities and 340B contract pharmacies with the development of HRSA-compliant inventory/dispensing methodologies, dispensing and invoicing of 340B drugs, as well as ongoing compliance initiatives and program management. That experience has translated into an in-depth, sophisticated understanding of the 340B program – an expertise that can assist you in setting-up and operating your 340B program.

Murer is acutely familiar with the benefits as well as the resulting compliance obligations of the 340B program. We have been assisting various types of covered entities, including disproportionate share hospitals, FQHCs, community clinics, and contract pharmacies with the 340B program components, including initial program feasibility, registration and implementation, situational audits, day-to-day compliance assistance, 340B voluntary disclosures, and 340B-Medicaid overpayments/ repayments. Once up and running, we will continually apprise you of regulatory developments that could impact your program, and help to plot responsive courses of action to ensure your continuing compliance with 340B regulations while minimizing added administrative costs.

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Frequently Asked Questions about 340B Programs

Certain hospitals and federal grantees (together “covered entities”).

No. Changes to the 340B program allow covered entities to utilize independent pharmacies, known as “contract pharmacies,” to dispense 340B drugs. Further, covered entities are permitted to dispense 340B drugs through multiple contract pharmacies.

Yes. Payer source is not taken into consideration in deciding who is eligible to receive 340B drugs. As long as the individual qualifies as a patient for purposes of 340B, they may receive 340B drugs. Note that reimbursement from private payers may, in many instances, exceed the 340B purchase price.

HRSA rules say that an individual is a 340B patient if each of the following conditions are met:

  1. The covered entity has established a relationship with the individual, such that the covered entity maintains records of the individual’s health care;
  2. The individual receives health care services from a health care professional who is either employed by the covered entity or provides health care under contractual or other arrangements (e.g., referral for consultation) so that responsibility for the care provided remains with the covered entity; and
  3. The individual receives a health care service or range of services from the covered entity that are consistent with the service or range of services for which grant funding or Federally-Qualified Health Center look-alike status has been provided to the entity. Disproportionate share hospitals are exempt from this requirement.

Covered entities benefit by reducing outlays for outpatient prescription drugs. These savings can be used to, among other things, expand the health care services it renders, thereby improving patient health outcomes.

Patients benefit by having access to reduced-cost drugs to which they otherwise would not have access.

Both federal and state governments benefit by saving money for outpatient prescription drugs dispensed to public aid beneficiaries.

Register with the Office of Pharmacy Affairs (OPA), an agency within the HRSA, and notify your drug distributor(s) of your participation with 340B. Contact State Medicaid agencies if you intend to dispense 340B drugs to Medicaid beneficiaries and seek reimbursement from a State Medicaid agency.

Murer Consultants is available to help with all aspects of establishing and operating a 340B program.

OIG and HRSA Have Increased Scrutiny of 340B Programs

The OIG and HRSA have recently increased scrutiny of the 340B program through recertification and audit efforts. HRSA conducts audits of covered entities’ 340B programs, focusing specifically on the prohibitions against drug diversion, duplicate discounts and group purchasing arrangements. State Medicaid agencies are also ramping up their audit and enforcement efforts to ensure that covered entities are administering their 340B programs in manners that result in savings to the Medicaid agencies. This is a particularly important initiative in many states in light of budget shortfalls.

A prominent matter of interest to several State Medicaid agencies is verifying that covered entities are submitting claims for prescription drugs at their actual acquisition cost (AAC). While federal law permits State Medicaid agencies to formulate their own billing policies, many states are now requiring covered entities to bill for prescription drugs at AAC. The effect of this policy change is to make sure that all 340B savings from Medicaid prescriptions are passed onto the State, a policy change that is bolstered by another recent development: many States are now requiring eligible 340B entities to enroll in the 340B program as a prerequisite to their participation in their respective Medicaid programs.

The Steps to An Effective 340B Audit

HRSA has been issuing findings in most of the audits it has been conducting since 2014. Many of the HRSA audits have resulted in the Covered Entity being levied with sanctions or repayments to manufacturers.

The best way to prepare yourself for a HRSA audit is to ensure that you are adhering to a simple system of “best practices.” Murer Consultants has documented these best practices, which include various types of assessments, and you can download them here by registering now.

HOW CAN WE HELP?

Our 340B compliance audit program, developed in full alignment with the audit process employed by HRSA, involves assessment as well as remediation. Our teams work closely with you to identify the procedures in place for compliance and we then strategize with you to develop processes to remediate and control flaws or weaknesses. As part of this work, we analyze the efficiency of your 340B program and look for ways to further maximize benefits.

Contact Murer at 708-478-7030.

or email Lyndean Brick at lbrick@murer.com for more information.

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