apexus 340b update and medicaid managed care what you … · ffs claims while the burden shifts to...

Chris Hatwig, MS, RPh, FASHP – President

Jason Atlas, RPh, MBA – Manager, 340B Education and Compliance Support

Apexus 340B Update and Medicaid Managed Care – What You Need to Know

© 2017 Apexus. Reproduction without permission is prohibited | 2

Provide an overview and update on the 340B program.

Describe trends in 340B Medicaid state plan amendment approaches pursuant to

the final AMP Rule.

Share best practices in 340B-Medicaid partnerships regarding duplicate discount

prevention.

Disclaimer- the information shared today is by Apexus

Learning Objectives


• Resulted from a 1992 federal statute

• Manufacturers participating in Medicaid Drug

Rebate Program must sign a Pharmaceutical

Pricing Agreement (PPA) with the Secretary

of Health and Human Services

The manufacturer agrees to charge a price for covered

outpatient drugs that does not exceed the 340B price

340B Statute and Intent

“To permit covered entities 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)


Certain Hospitals Federal Grantees/Designees

• Disproportionate share hospitals

• Children’s hospitals

• Critical access hospitals

• Free standing cancer hospitals

• Rural referral centers

• Sole community hospitals

• Federally qualified health center

• Federally qualified health center look-alikes

• Title X family planning grantees

• State AIDS drugs assistance programs

• Ryan White care act grantees (A,B,C,D,F)

• Black lung clinics

• Hemophilia treatment centers

• Native Hawaiian health centers

• Urban Indian organizations

• Sexually transmitted disease grantees

• Tuberculosis grantees

340B Eligible Entities


HRSA 340B Database

April 1, 2017

• 12,400 covered entities with 27,200 associated sites

• 19,340 unique contract pharmacies

HRSA 340B Database: Statistics


Respondents report that they use 340B drug discount program savings to expand patient

access to medicines and improve pharmacy services in numerous ways*:

• 77 percent say 340B enhances their ability to serve the uninsured or underinsured

• 71 percent say it increases their ability to provide free/discounted drugs to low-income patients

• 65 percent say it funds patient counseling

• 62 percent say it funds hospital readmission-reduction programs

• 60 percent say it funds medication therapy management

http://www.340bhealth.org/news/report-340b-program-helps-hospitals-serve-the-poor-more-important-than-ever/

340B Savings

http://www.340bhealth.org/news/report-340b-program-helps-hospitals-serve-the-poor-more-important-than-ever/


A pharmacy that enters into an agreement with a covered entity to provide services to the

covered entity’s patients, including dispensing entity-owned 340B drugs.

What Is a Contract Pharmacy?

COVERED ENTITY CONTRACT PHARMACY 340B VENDOR


HRSA requires the covered entity to maintain ownership

of the 340B medication up to dispensing to eligible

patient

• Inventory via “bill to – ship to” wholesaler arrangement

• Covered entity receives invoice

• Contract pharmacy receives inventory without 340B pricing

information

Contract Pharmacy Bill To – Ship To Overview

Bill ToShip To

WHOLESALER

COVERED ENTITYCONTRACT PHARMACY


Physical inventory vs. virtual inventory/replenishment

340B status determination

Can the entity/pharmacy determine 340B status at the point of adjudication?

• Flat file

• HL7

• Combination

340B Inventory Models: Unique/Challenging


Apexus Solutions

Federal contract with HRSA’s Office of Pharmacy Affairs

• Supplier and distributor contracting

• 340B University and 340B U OnDemand

• Apexus Answers call center

• Advanced operational training by the industry leader in 340B education

• Industry standard for validated 340B expertise

• Provides specialized training targeting compliant 340B implementation

• 50+ hours of comprehensive policy and implementation instruction

• The health system solution for specialty pharmacy

• Improves access

• Open to organizationsof all sizes and types, regardless of GPO affiliation

340B Prime Vendor ProgramAdvanced 340B Operations Certificate Program

Acentrus


HRSA Audits by the Numbers

FY 2012(As of

07/29/16)

FY 2013(As of

07/29/16)

FY

2014(As of

07/29/16)

FY

2015(As of

07/29/16)

FY 2016(As of

11/15/16)

FY

2017*(As of

3/30/17)

Number of covered entities

audited

51 94 99 200 200 70

• Outpatient facilities/sub-

grantees410 718 1,476 2,720 4,011 1,002

• Contract pharmacies 860 1,937 4,028 4,443 3,531 1,501

Number of finalized reports 51 94 99 200 148 6


Civil Monetary Penalties (CMP) interim final rule has delayed the effective date to 5/22/2017

– HRSA sought comments through 4/19/2017

– HRSA may delay further until 10/1/2017

Mega-Guidance

– OMB withdraws HRSA mega-guidance

ACA Reform

Regulatory Updates


340B UniversityTrends: Medicaid and 340B

Apexus is supporting:

• Access to State Medicaid 340B contact and policy information

• Sharing Best Practices for reimbursement and duplicate discount

prevention

• HRSA, who is working with CMS to identify solutions in the

Medicaid space



340B price Medicaid rebate

Duplicate Discount Prohibition: FFS and MCO


HRSA 340B Database: Medicaid FFS


How does the Medicaid Exclusion File work? FFS Medicaid

State

340B

Discount

Medicaid

Rebate

Covered Entity

Manufacturer

Medicaid

Exclusion

File

© 2017 Apexus. Reproduction without permission is prohibited


Medicaid Exclusion File

• MPN and/or NPI

Medicaid Drug Rebate Data Flowchart – Medicaid MCO

State Medicaid

Claims Administrator

Office of Pharmacy

Affairs

Covered Entity

Medicaid MCO

Health Plan

Manufacturer

MCO Claim Data Elements

• Patient Identifier

• NDC

• Units

• Medicaid Provider Num/NPI

• Claim modifier indicating

340B drug (some states

Covered Entity fails to carve out

managed Medicaid utilization or dual

eligible utilization

MMCO Health Plan fails to

utilize Exclusion File or other

mechanism before providing

rebate to the state

MCO Claim Data Elements

• Patient Identifier

• NDC

• Units

• Medicaid Provider Num/NPI

• Claim modifier indicating

340B utilization

Covered Entity fails to list all MPNs or NPIs

Medicaid Exclusion File

• MPN and/or NPI

State agency fails to properly

utilize most current Medicaid

Exclusion File or other

mechanism

Rebate Request Data Elements

• NDC

• Units

• Claims-level detail available from some states

upon request

• Excludes claims where MPN or NPI on

Medicaid Exclusion File or claims with a

modifier indicating a 340B drug was utilized


Retail:

Entity-Owned

Retail:

Contract

Physician

Administered Drugs

Fee for Service

Managed Care Medicaid

340B Medicaid Framework


HRSA, CMS and State 340B Policy

HRSA Policy: CE must

• Prevent duplicate discounts

• Use the Medicaid Exclusion File

• Bill according to the state policy

CMS Policy: States must

• Collect rebates on claims

• Establish 340B reimbursement methodology

State Policy: States and CE must

• Prevent duplicate discounts by…

• Adhere to Medicaid reimbursement guidance by…


The COD final rule was published on February 1, 2016, and provided required changes that

all States must make in their reimbursement for Medicaid fee for service (FFS) claims.

The states must reimburse 340B entities and their contract pharmacy providers for FFS

based on:

• Actual acquisition cost (AAC) plus

• A professional dispensing fee (PDF) established by the single state agency.

The covered entity (CE) has primary responsibility for preventing duplicate discount for

FFS claims while the burden shifts to the state for managed care claims.

Although the COD Rule does not directly address duplicate discounts, it is very important

that the risk of duplicate discounts is mitigated in the development of a State Plan

Amendment (SPA) – Medicaid and CHIP Managed Care final rule – CMS-2390-F

CMS Covered Outpatient Drug (COD) Rule and MCO Rule


The states must develop a SPA that contains

reimbursement methodology that the state plans to use

to establish the 340B ceiling price as well as the

professional dispensing fee, and state how this

methodology will be incorporated into its FFS pharmacy

reimbursement policies. This SPA addressing 340B FFS

reimbursement changes must be in effect on April 1,

2017 and filed with CMS by June 30, 2017.

State Plan Amendment (SPA)

State


• NADAC

• 340B MAC

• 340B Ceiling price

• 340B AAC

• SCC

• COD Survey

• FUL

• National Average Drug Acquisition Cost

(The new AWP)

• 340B calculated Maximum Allowable

cost

• Submission Clarification Code – NCPDP

standardized D.0 fields for claims

• Cost of Dispensing Survey

• Federal Upper Limit

State Plan Amendment (SPA)


The MMCOs are NOT required to abide by the COD rule and are not required to reimburse

product at AAC plus a PDF determined through a cost to dispense study. The

reimbursement rates are typically determined by the contract between the MMCO (or their

pharmacy benefit manager), and the pharmacy network provider.

Medicaid managed care programs are not directly impacted by the regulation with the

exception that the States are required to collect rebates on the drugs that are provided by

contracted MMCOs.

–The managed Medicaid program is required (which should be in their contract with the state)

to state what encounter claims are to be submitted and how those ineligible for rebate (340B)

are identified.

COD Rule and MMCO


Decision for FFS will be considered the same decision for MCO – carve-in or carve-out

• Some states utilize MEF

• Some require attestation to the state on decision

Retail Claims

• 340B ceiling vs. 340B AAC vs. 340B calculated price vs. 340B MAC price

Physician Administered Drugs (PAD)

• 106% of ASP vs. 340B AAC

FQHC reimbursed at different rates in comparison to hospitals

Some states considering carving out pharmacy benefit from Managed Care plan and retaining

within FFS

Contract Pharmacy

• FFS exclusions. What about Managed Care exclusion?

• Oregon model for retrospective identification of contract pharmacy

State Plan Amendments – What are the Trends?


Submission Clarification code requirements

• Works only with closed door in-house pharmacy and only in

simple health systems

• Ineffective in complicated settings that utilize retrospective

340B identification software systems

• Ineffective for contract pharmacy using replenishment

Reimbursement

• Contracts with different reimbursement for 340B participants

and their contract pharmacy

• Requirements for pharmacy to provide the 340B Actual

Acquisition Cost

340B Participant challenges with PBM contracts

“To permit covered entities 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)


Questions

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apexus 340b update and medicaid managed care what you … · ffs claims while the burden shifts to...

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