Transcript 340B discount

NCHA and SUNRx
MegaGuidance Overview
October 19, 2015
© 2014 SUNRx, Inc. All rights reserved.
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© 2014 SUNRx, Inc. All rights reserved.
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340B: MegaGuidance Overview
For NCHA Hospitals
Presented By:
Brian Ward, R.Ph.,
Vice President Regulatory Affairs and Compliance
SUNRx, LLC
The contents of this presentation are confidential and proprietary to SUNRx, Inc. and may contain material MedImpact considers Trade Secrets. This
presentation may not be reproduced, transmitted, published or disclosed to others without SUNRx’s prior written authorization.
© 2014 SUNRx, Inc. All rights reserved.
Agenda
• Overview of the 340B program
• Key Regulations
• MegaGuidance
• Other Regulatory Activities
© 2014 SUNRx, Inc. All rights reserved.
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What is 340B?
• 340B is a federal program that allows qualified
entities (“340B Covered Entities (CE)”) to:
– Purchase “outpatient” pharmaceutical products at
a substantial discount—25% to 50% discount
– Create savings for safety net organizations to
provide more comprehensive care
– Can be used for ALL entity patients
– Can utilize either in-house or contract pharmacies
© 2014 SUNRx, Inc. All rights reserved.
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What Hospitals are Eligible?
Hospitals
DSH Adjustment %
Disproportionate Share Hospitals
(DSH)
11.75%
Critical Access Hospitals (CAH)*
No DSH % Requirement
Rural Referral Centers (RRC)*
8%
Sole Community Hospitals (SCH)*
8%
Children’s Hospitals
11.75%
* Rural Hospitals added in 2010 as part of the Affordable Care Act
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Key Regulations—Diversion
Diversion
• 340B may only be used for “Entity Patients”
• Diversion—Using 340B drugs for non-qualified
purposes, such as:
– Inpatients
– Prescriptions written at non-cost reported
(non-registered) facilities
– Prescriptions from non-documented referrals
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Key Regulations—Duplicate Discounts
Entities must protect manufacturers from “Duplicate Discounts”
A payment of both a Medicaid rebate and a 340B discount on
the same claim constitutes a “duplicate discount”
Duplicate Discounts
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Entity Specific Prohibitions
GPO Prohibition (DSH and Children’s Hospitals)
– Entity MAY NOT USE GPO drugs for any outpatient
– Must have a tracking system (Split Billing)
– Three account types:
• GPO Drugs (inpatient)
• 340B (340B eligible outpatients)
• WAC (non-340B eligible outpatients)
Orphan Drug Prohibition (CAH, SCH, RRC)
May not use 340B for orphan drugs for the original Orphan Diagnosis
Entity may opt-in/opt-out to using 340B for orphan drugs
Just in:
10/15/15—PhRMA challenged HRSA’s Orphan interpretation and won
Entities can no longer use 340B for Orphan Drugs—for any diagnosis
© 2014 SUNRx, Inc. All rights reserved.
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HRSA MegaGuidance
August 27, 2015--HRSA released its long awaited
MegaGuidance—clarifying the 340B regulations
May 2015
August 27th
Oct 27th
Dec 2015
Submitted
To OMB
(up to 90 d)
Mega
Guidance
Released
(60 day
Comments)
Comment
Period Ends
Finalize
Guidance
Jan 2015
MegaGuidance
Announced
by HRSA
2016
Begin
Implementation
Expected to take up to a year to finalize
HRSA may finalize incrementally
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Today’s Three Patients Eligibility Requirements
• An individual establishes a relationship with the Covered Entity
(i.e., visits to a qualified/registered facility)
Facility Requirement
• The Covered Entity maintains the records of the individual’s
health care Record Requirement
• The patient is seen by a health care professional who is
employed, contracted, or through other arrangements (such
as a referral for consultation), such that the “responsibility for
care” remains with the entity
Provider/Responsibility for Care Requirement
Six elements under HRSA’s Proposed MegaGuidance
© 2014 SUNRx, Inc. All rights reserved.
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New MegaGuidance– Patient Eligibility
• The individual receives a health care service at a facility or clinic site which
is registered for the 340B program and listed on the 340B database; Facility
Requirement (current—but clarified)
• The individual receives a health care service provided by a CE provider who
is either employed by the CE or who is an independent contractor for the
CE, such that the covered entity may bill for services on behalf of the
provider as a result of the service described above; Privileges or
credentials with a 340B hospital would no longer be “sufficient to
demonstrate that an individual treated by that privileged provider is a
patient of the covered entity for 340B program purposes.” Provider
Requirement (new—excludes referrals and privileged providers, concern
with ER services)
• The individual’s patient records are accessible to the CE and demonstrate
that the CE is responsible for care. Record Requirement (current—but
clarified)
© 2014 SUNRx, Inc. All rights reserved.
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New MegaGuidance—Patient Eligibility
• The individual’s health care is consistent with scope of the CE’s federal
grant, project, designation, or contract; Scope Requirement (applicable to
grantees only)
• The individual receives a drug that is ordered or prescribed by the CE
provider; Drug Requirement (new—limits patient eligibility to prescribing
visits only)
• The individual’s drug is ordered or prescribed pursuant to a health care
service that is classified as outpatient; Outpatient Requirement (current—
but limits discharges, patient admissions)
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Proposed MegaGuidance—Significant Elements
Patient Eligibility
• Disallows all prescriptions from private practices, even if follow-on or
referrals
• Eliminates “affiliation arrangements” with outside organizations
• Allows scripts only from employed or independently contracted
providers, such that the entity bills for the provider services
• Eliminates prescriptions by “privileged/credentialed” providers
• Disallows 340B eligibility for discharge prescriptions
• Eliminates blanket 340B eligibility for self-insured employees
© 2014 SUNRx, Inc. All rights reserved.
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Proposed MegaGuidance—Significant Elements
Medicaid Duplicate Discount
• Proposes a new mechanism for entities to separately elect to carve-in/out Feefor-Service Medicaid from MCO Medicaid
• Requires entities to block FFS and MCO Medicaid at contract pharmacies (or
create other arrangements to prevent duplicate discounts)
Contract Pharmacy Elements
• Requires pharmacy registrations to be submitted by covered entities only
• Requires quarterly self-audits and annual independent audits
Split Billing Elements
• Eliminates 340B for infused drugs prescribed by outside providers
• Excludes 340B drugs bundled as a single payment under Medicaid
• Clarifies three possible exceptions to the Hospital GPO Prohibition
• Eliminates 340B used on outpatients later admitted as inpatients
© 2014 SUNRx, Inc. All rights reserved.
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Other 340B Regulatory Activities
Congressional Activities
• Potential Congressional Legislation
(not yet introduced by Congress)
o
o
o
o
o
Program intent
Use of 340B funds
Minimum Rx discounts
Mandatory independent audits
Hospital eligibility (replace
eliminate DSH%)
o Patient definition
Other Activities
• Exchanges and Medicaid expansion
moving more uninsured to insured
• Lower reimbursement is driving
patients to safety net providers
• Expect continued attacks on 340B
(political posturing)
340B will continue to provide high market value
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NCHA and SUNRx
Contacts
Brian Ward
267-648-5886
[email protected]
Jeff Spade
919-677-4223
[email protected]
Ronnie Cook
919-677-4225
[email protected]
Jody Fleming
919-677-4130
[email protected]
www.nchastrategicpartners.org
© 2014 SUNRx, Inc. All rights reserved.
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