rx office hours: important

Rx Office Hours:

IMPORTANT

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Pharmacy Access Office HoursSeptember 20, 2018

Focus Topic: Medicaid and Rx

This activity is supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) under a

cooperative agreement. This information or content and conclusions are those of the author and should not be construed as the official position or policy of,

nor should any endorsements be inferred by HRSA, HHS or the U.S. Government.

Today’ Agenda

• Operational updates

• Brief presentation on “focus topic” – Medicaid and Rx

• Open Q&A

• Link to two-question evaluation https://www.surveymonkey.com/r/ZWW7QC2

Please use the Chat Box during the session to ask questions, add info, etc. There will be

time for Q&A at the end.

Documents available for immediate download

• The slides from this presentation

• The Medicaid chapter from the NACHC 340B Manual

• To access them:

- Search for “NACHC 340B”

- Scroll about halfway down the page, and look under “Office

Hours” then “Sept 2018”

OPERATIONAL UPDATES

Colleen Meiman

Senior Policy Advisor

National Association of Community Health Centers

[email protected]

More Oversight of Contract Pharmacy Registrations

• Starting In October, HRSA will select a random sample of new contract

pharmacy arrangements that are registered on its database.

• Randomly-selected providers must send HRSA a

copy of their contract with the pharmacy.

• HRSA will review the contract to ensure it:

1. Is dated prior to the registration period

2. Lists all provider and all contract pharmacy locations, with addresses

that are identical to those that were registered.

3. Includes signatures of officials from both the entity and the pharmacy.

Regulation on Ceiling Prices & Fines on Manufacturers

• This regulation was:

– required by the ACA in 2010,

– published in the last days of the Obama Administration,

– delayed 5 times by the Trump Administration,

– now scheduled to become effective in July 2019.

• Last month, Congressional leaders from both parties and houses

wrote HRSA to request it become effective ASAP.

• This month, several hospital association filed a lawsuit to have it

made effective.

The end of “gag clauses” on pharmacists?

• “Gag clauses” on pharmacists prohibit

them from telling patients when the cash

price of a drug is less than their insurance

copayment.

• Several states have taken steps to ban

gag clauses.

• Congress is now taking action as well.

–Bills banning gag clauses in Medicare

Part D and private insurance are now

making their way through both Houses.

Coming Soon! An On-Line Forum

• We will soon launch an on-line discussion/ collaboration forum focused

exclusively on pharmacy access issues for health centers.

• Platform will be “Noddlepod” – being used by NACHC for other T&TA

activities, with good results.

• Intended to be a “safe space” for questions and discussions, as well as a

repository for easily-accessible information.

–Access will be limited to staff from health centers, PCAs, HCCNs, NACHC, and

Apexus. You will need to sign up, and be approved.

• Want to help launch it? You can sign up today – link is in the evaluation

survey -- https://www.surveymonkey.com/r/ZWW7QC2

A Couple Reminders

1. Whenever possible, please register your sites with

HRSA during the regular two-week window at the

start of the quarter.

The extended windows should be used only when

absolutely necessary.

2. For a Mirena-like IUD at $50 each, contact

[email protected]

3. FQHCs may use 330 funds to purchase Emergency

Contraception, and to dispense it to their patients.

Want

more info

on these

items?

See slides

from July

Office

Hours.

mailto:[email protected]

SUMMARY OF OPERATIONAL UPDATES

1. HRSA now requires randomly-selected providers to submit signed

contracts for review before allowing them to register a contract

pharmacy arrangement.

2. Congress and hospitals associations are pushing for the Ceiling

Price regulation to go into effect.

3. Congress is moving to ban “gag clauses” on pharmacists.

4. Coming soon – an on-line discussion forum on “Noddlepod” for

health center pharmacy access issues.

Looking Ahead

Thursday October 18, 2:00 – 3:00 Eastern

Focus Topic: Either DIR Fees or Effective Pharmacy

Oversight Committees

Thursday November 15, 2:00 – 3:00 Eastern

Focus Topic: Dashboards for Tracking Pharmacy

Performance

Focus Topic:

Medicaid and Pharmacy

Presenter:

Gavin Magaha

Manager, 340B Education and Compliance Support

Apexus

Update: Medicaid, 340B, and PharmacyGavin Magaha, PharmD, MS, Manager 340B Education and Compliance Support

| 15© 2018 Apexus. Reproduction without permission is prohibited

Agenda

• High-level review: what is a duplicate discount

• Carve-IN vs Carve-OUT

• Medicaid Exclusion File

• Issues with Fee For Service (FFS) and Medicaid Managed Care

Organizations (MMCO)

• 340B Marketplace Trends


340B and Duplicate Discounts

• A duplicate discount occurs when

• A covered entity purchases a drug at 340B

pricing and uses that drug on a 340B

patient

• The covered entity requests Medicaid pay

for the drug

• Medicaid then bills the manufacturer for a

rebate for that drug

• The manufacturer pays the rebate = a

duplicate discount


Avoiding Duplicate Discounts

Carve-IN

• Covered entity purchases drug for

Medicaid patients; upfront 340B discount

• Medicaid receives the benefit of the

discount upfront from the 340B entity and

therefore is NOT able to seek a rebate

Carve-OUT

• Covered entity does NOT purchase the

drug for Medicaid patients at 340B;

purchase made on a non-340B account

• Medicaid should seek a rebate from the

manufacturer


Medicaid Exclusion File

• HRSA established the Medicaid Exclusion File (MEF) as a tool to assist stakeholders in

preventing duplicate discounts

• A list of National Provider Identifiers (NPIs) and/or Medicaid Provider Numbers (MPNs) used for billing

• Informs state to exclude all claims from listed NPI/MPNs from the rebate file

• FFS only (not used for MCO claims)

• MEF used as source of truth for manufacturers and others

• Main limitation = all claims from NPI/MPNs must be treated the same

• Static database; published once a quarter (14 days prior to the start of the next quarter)


Oversight and Governing Bodies

CMS Policy

• Requires states to collect rebates on claims (including MCO and clinic administered)

• 340B drugs are not subject to these rebate collection requirements

State Policy

• How will duplicate discounts be prevented in the state?

• 340B billing and reimbursement requirements

HRSA Policy

• Direct program oversight; requires prevention against duplicate discounts

• Developed the Medicaid Exclusion File to help stakeholders

• Bill according to the state policy (no HRSA AAC requirement)


Duplicate Discounts – Medicaid Fee for Service

• HRSA requires covered entities that carve in (purchase 340B for Medicaid patients) to be

listed on the Medicaid Exclusion File (MEF)

• HRSA has clarified this is only required for Medicaid fee for service

• States use the MEF to identify 340B dispenses via NPI or MPN (not claim level).

• Some states require systems to identify 340B purchased drugs at the claim level

• NCPDP codes (08/20) are often used for retail claims,

• Claim modifiers such as “UD” are used in the clinic administered setting

• There are several factors that make this process difficult for 340B entities:

• Eligibility is often determined retrospectively and is not know at the point the claim is sent.

• Billing system sometimes lack the ability to change claim level data based on payers.

• For these reasons, 340B is rarely used in contract pharmacies for Medicaid patients.


Duplicate Discounts – Medicaid Managed Care

• HRSA does not specifically address compliance under Medicaid Managed Care (MMCO)

• Working with CMS to develop a policy

• HRSA encourages 340B entities to work together with states to prevent duplicate discounts

• MMCO plans present challenges for CEs

• States individually negotiate processes for MMCO plans to identify 340B dispenses for exclusion

• CEs should contact states to learn state-specific processes for every state they serve

• This may mean having multiple processes in place based on payer

• Identifying MMCO patients is problematic; private plans vs managed Medicaid may not be

distinguishable


Duplicate Discounts – Other Complexities

• Bundle-billed/reimbursed drugs

• Are they being accurately captured?

• Is the state seeking rebates for these medications?

• Dual eligible patients

• How does the state handle patients who are dual eligible?

• Is the state seeking rebates for these medications?

• Medicaid-pending patients

• How does the CE bill/rebill patients?

• Are accumulators correctly adjusted?

• How does your state handle items not available at 340B pricing?


Health Centers – Carve-IN %age by state

Highest % Carve-In States

Connecticut 19%

Oklahoma 17%

Rhode Island 13%New Hampshire 10%Wyoming 0%

Lowest % Carve-In States

Washington 93%

Massachusetts 89%

Arizona 83%

Oregon 83%

Tennessee 77%


National Trends

Approaches to prevent duplicate discount

• 85% reimburse retail 340B claims based on 340B Actual Acquisition

Cost from invoice

• 51% require retail 340B claims to have claim level identifiers

• 64% prohibit dispensing 340B drugs to Medicaid patients through

contract pharmacies

Other trends

Duplicate Discounts

340B

discountMedicaid

rebate


340B University OnDemand


Apexus Answers Call Center

Apexus Answers Call CenterApexus Answers Call Center 888-340-BPVP (2787)

© 2018 Apexus. Reproduction without permission is prohibited | 27

www.340bpvp.com

@Apexus340B

#340B

#340BUniversity

February 2018

888-340-BPVP (2787)

Medicaid Reimbursement for 340B Drugs

• Rules differ based on whether drug is reimbursed under Fee-

for-Service (FFS) or Managed Care (MCO.)

• Note: For any given drug, the dollar value of the 340B

discount is identical to dollar value of the Medicaid rebate.

340B Rx reimbursed under Fee-for-Service:

• Federal rules require that States pay no more than the 340B

ceiling price plus a professional dispensing fee (pdf.)

• If the health center’s Actual Acquisition Cost (AAC) is less

than the 340B ceiling price, the state can pay only the AAC

plus the pdf.

• So the benefit of the 340B discount – and possibly sub-ceiling

discounts – accrues to the State.

• The pdf must based on recent data and analysis.

340B Drugs reimbursed under Managed Care:

• There are no federal requirements around reimbursement.

• However, Federal law does not prohibit States from reimbursing

at the 340B ceiling price or Actual Acquisition Cost (AAC),plus a

professional dispensing fee (pdf.)

• Many groups are seeking to access these savings – State

Medicaid programs, MMCOs, PBMs, TPAs, etc.

• Important to keep an eye out for these efforts, and push back.

Q&A

Link to two-question evaluation: https://www.surveymonkey.com/r/ZWW7QC2

Physician-Supervised Dispensaries

Q: If a health center has a physician-supervised dispensary (instead of a

pharmacy, which is supervised by a pharmacist):

• What are the rules around billing Medicare?

• What are some common issues around billing Medicaid?

• Would the dispensary be eligible to obtain its own DEA number, or

must it use the physician's DEA number instead?

Link to two-question evaluation:

https://www.surveymonkey.com/r/ZWW7QC2

Shortages? Medicaid & Modifiers?

Q: Are any health centers experiencing shortages of any of

the following drugs: Lidocaine, Fluorescein, Zofran, and

Nitroglycerin? If so, any strategies for dealing with

them?

Q: “We are getting ready to approach our state about

requiring the 20 modifier on contract Pharmacy claims.

Any suggestions on how to do this?”

Link to two-question evaluation: https://www.surveymonkey.com/r/ZWW7QC2

PBMs

Q: Are health centers being told by PBMs or payers that they must:

• either become specialty pharmacies or stop dispensing high-

costs drugs?

• start including a modifier on all 340B purchased drugs?

• attest to the percentage of their claims that they fill through

340B?

Link to two-question evaluation:


Other Questions?

Please complete the two-question evaluation:


Contact: Colleen Meiman, [email protected]

mailto:[email protected]