beyond the pharmacy - Texas Organization of Rural ... · beyond the pharmacy Common 340B program...

beyond the pharmacy Common 340B program concerns for hospitals

Making sure expectations meet realityMarch 13, 2015

Lidia A. Rodriguez-HuppSVP & 340B Compliance Officer

Christopher BolesRegional VP, Sales

CONFIDENTIAL | © 2015 Sentry Data Systems, Inc. | No unauthorized reproduction.

course overview

340B overview: compliancethrough the years

Developing policies and procedures to address compliance risks

Enforcingcompliance with HRSA audits

Tailoring a compliance plan for your organization

340B compliance: it’s everybody’s business

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340B overview: compliance through the years


the intent of 340B

To stretch scarce Federal resources as far as possible, reaching more eligible patients and providing more comprehensive services*

* H.R. Rep. No. 102-384(II), at 12 (1992)

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what is 340B

A federal drug discount program that requires manufacturers to provide outpatient drugs at greatly discounted prices to covered hospitals or entities

locationsstrictly-outpatient settingsPhysician-owned clinics

mixed-use settingsDepartments such as ED,where patients can be bothinpatient and outpatient

OP discharges toOP pharmaciesHospital-owned or contractpharmacies, such as CVS orWalgreens

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recertify

register

to participate in 340B, an entity must

ensure it has the capability to follow and maintain auditable records documenting compliance with program rules

on the HRSA 340B database

with HRSA 340B annually

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annual 340B recertification

> Offsite clinics and departments associated with a child site of a parent hospital must individually register as child sites of the covered entity• Even when they share the same building or have been registered

previously as a single child site

> Outpatient clinics and individual parent hospital departments do not need to register separately • Must maintain auditable records

As of 2012, HRSA rules require that all covered entities recertify their compliance with all 340B program rules on an annual basis

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340B GPO and orphan drug

Applies to less than 500 of the 2,600 drugs with orphan status

Requires participating entities to track use, ensure drugs are not purchased under 340B for those conditions and diseases it has received orphan drug designation, and maintain auditable compliance records

Drugs can be sold at 340B prices if being used to treat conditions/ diseases other than those for which the drug received designation

The GPO prohibition pertains to these entities:

Drug purchases through GPO (Group Purchasing Organization) contracts cannot be used for outpatients covered by 340B

The orphan drug exclusion pertains to:

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Developing policies and procedures to address compliance risks


historical review of audits*

*134 of the 145 HRSA audits have posted results

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HRSA audits

> Number of outpatient facilities

> Number of contract facilities

> Complexity of the 340B program

> Volume of 340B purchases

> Parent sites in the program for more than 1.25 years are not subject to audit selection through risk-based factor

Risk-based factors related to selection include: Target audits

focus on specific violations or allegations regarding diversion or duplicate discount

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avoiding duplicate discountsDrug manufacturers cannot be subject to both the 340B discount and the Medicaid rebate. Hospitals dispensing outpatient drugs in a mixed-use setting must choose either a carve-in or carve-out policy to prevent double discounts

Covered entities (CEs) decide they will use 340B-priced drugs for their Medicaid patients in the outpatient settingCEs must submit billing transactions with 340B acquisition prices for the drugs being dispensed

Depending on the entity type, CEs decide they will use either wholesaler acquisition cost (WAC) or their GPO account for their Medicaid patients in the outpatient setting340B drugs are only dispensed to non-Medicaid outpatients

carve-in carve-out

Note: Contract pharmacies primarily exclude Medicaid and Medicaid Managed Care, unless under other arrangement with the state.

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GPO exclusion

> The hospital should establish a non-340B, non-GPO (e.g., wholesale acquisition cost (WAC)) account for instances where drugs cannot be purchased using the hospital’s 340B or GPO account

> First purchase of any outpatient NDC should be made using a WAC account

> CII narcotics

DSH, children’s and freestanding cancer hospitals are prohibited from obtaining covered outpatient drugs through group purchasing organization (GPOs)

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patient eligibility and diversion

> This includes ineligible facilities and excluded services within the covered entity

> The covered entity must consider: • Mixed use settings • Covered and non covered areas within same facility • Inventory tracking systems and audit trails • Security and theft risks

Anti-diversion requirements prohibit the resale or transfer of 340B outpatient discounted drugs to individuals not considered patients of the covered entity

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eligibility requirements

Patient• Has an established relationship with

the CE, which maintains care records• Receives an outpatient service from

an eligible provider• Excludes lab and diagnostic-only

services

Provider• Employed by, or under contractual

arrangement with, the CE • Provides care to the patient

Drug• The drug is on the 340B list,

limited to outpatient use and provided to an eligible patient

Location• The location is 340B eligible and above

the line on the Medicare cost report

Medicaid• Carve-in or carve-out considerations

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where GPO can be used

> In the hospital’s inpatient areas

> In certain offsite outpatient facilities if the following criteria are met:• Located at a different physical address• Not registered on the 340B database• The hospital maintains records demonstrating that

drugs purchased through the GPO are not utilized or otherwise transferred to the parent hospital or registered outpatient facilities

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Medicaid and duplicate discounts

> Double-dipping occurs when a state seeks a Medicaid rebate on the same drug a manufacturer sold to a CE at a discounted price under the 340B program.• Double-dipping prohibition puts onus on the CE and the state

> OPA Medicaid exclusion files: CE must include provider numbers if they are billing Medicaid (carve-in) and the state must check file prior to applying for rebates.

Review federal and state policy

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contract pharmacy agreements

> All contract pharmacies are registered with OPA and appear on the OPA website

> The CE has the accountability for compliance with 340B program requirements

> Patients are free to choose any pharmacy

> Hospital is billed for 340B drugs shipped to contract pharmacy

Agreements should address all compliance elements suggested by HRSA Contract

pharmacy registration deadlines

10/15 for 1/1/14 listing


4/15for 7/1/14 listing


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Enforcing compliance with HRSA audits


what happens in a HRSA audit

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OPA / HRSA audit components

> Medicaid testing

> Split-billing software review

> Program registration review

> Policies & procedures review

> Adherence to the GPO prohibition

> Interview of key hospital participants

> Patient testing and tracking for eligibility

> Program understanding and resource allocation

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evaluating your 340B solutions

Looking under the hood

Reports

Does your solution offer easy-to-assess reporting that can be set to run automatically?

Audit tool

Does your solution offer a built-in, easy-to-use audit tool?

Configuration options

Does your solution offer multiple configuration options to meet the unique needs of your organization?

Compliance / audit support team

Does your vendor offer you support and a dedicated team to assist you and your consultants?

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data required for audits

Provider file

340B inventory

Organizational chart

340B purchase orders

Contract pharmacy listing with contracts

340B certification documentation

> Drug

> Payer

> NCD number

> Provider name

> Unique ID number

> Patient ID number

> 340B acquisition price

> Quantity dispensed or issued

Plus six months of drug data:

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Tailoring a compliance plan for your organization


fundamental elements

Develop and adhere to policies and procedures that configure to vendor software

Provide appropriateemployee education and training

Investigate and report detected offenses and develop an action plan

Develop and follow through on enforcement of disciplinary standards

Create an environment ofopen communication and information sharing

Enlist senior leadership as part of your multidisciplinary compliance team

Continue to demonstrate the community benefit that is a direct result of your 340B-generated savings

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annual monitoring and auditing

> If using vendor software, learn how the solution is configured • Does the configuration align with your organization’s P&Ps?• Some software vendors have tools and staff to assist you

in self audits/mock audits and can provide training on their systems for your consultants.

> Understand the reports available from your 340B vendor system, the information contained in them and the suggested frequency of review

> Do not assume staff are accessing reports

Perform an annual review of overall systems and a monthly sampling of dispensations

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340B compliance: it’s everybody’s business


responsibilities (HRSA website)

> Prevent duplicate discounts

> Prevent diversion to ineligible patients

> Maintain auditable records documenting compliance

> Keep 340B database information accurate and up to date

> Register new outpatient facilities and contract pharmacies (if applicable)

> Recertify eligibility every year

> Not participate in a GPO for covered outpatient drugs (as applicable to particular CE)

To purchase drugs at the 340B price, covered entities must:

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stakeholder involvement

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ongoing learning support

• Your state association

• 340B University• SNHPA

• HMFA• Others

Continually educate your internal resources on current federal and state policies

Encourage annual and as-needed education, much like we do for HIPAA and other areas

Make resources available including conferences, webinars, articles and reports

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references

> 340B Drug Pricing Updates: Healthcare Accounting News http://www.fdcpa.com/Healthcare/0214-healthcare-340b-drug-pricing-program-updates.htm

> Program Integrity Audit Results: http://www.hrsa.gov/opa/programintegrity/auditresults/index.html

> Orphan Drug List http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfmOR http://www.hrsa.gov/opa/programrequirements/orphandrugexclusion/orphandruglist.pdf

> Recertification Overview http://www.hrsa.gov/opa/programrequirements/recertification/index.html

> Database Guide to Recertification http://opanet.hrsa.gov/opa/Manuals/OPA%20Database%20Guide%20for%20Public%20Users%20-%20Recertification.pdf

> SNHPA 340B compliance checklist, last updated October 18, 2013: contact SNHPA at 202.552.5851

> Accountable vs Responsible http://www.diffen.com/difference/Accountability_vs_Responsibility

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http://www.fdcpa.com/Healthcare/0214-healthcare-340b-drug-pricing-program-updates.htm

http://www.hrsa.gov/opa/programintegrity/auditresults/index.html

http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm

http://www.hrsa.gov/opa/programrequirements/orphandrugexclusion/orphandruglist.pdf

http://www.hrsa.gov/opa/programrequirements/recertification/index.html

http://opanet.hrsa.gov/opa/Manuals/OPA%20Database%20Guide%20for%20Public%20Users%20-%20Recertification.pdf

http://www.diffen.com/difference/Accountability_vs_Responsibility

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© 2015 Sentry Data Systems, Inc. All rights reserved. No unauthorized reproduction.

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beyond the pharmacy - Texas Organization of Rural ... · beyond the pharmacy Common 340B program...

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