RPh Innovations, LLC (RPHI) delivers customized pharmacy, healthcare, and 340B solutions to safety net organizations. In this webinar, RPHI will be discussing each manufacturer block and the steps to designate contract pharmacies. We will be focused on navigating these blocks and creating a roadmap to recoup some, if not all, of the savings that were lost. We have put significant time and effort into understanding the challenges, implications, and alternative options related to the actions Manufacturers have taken over the past year. In this webinar, we share our findings, actions, and results with members. 1. Review of Manufacturer Actions 2. Steps required to designate a Contract Pharmacy 3. Challenges faced 4. Real case scenario 5. Tips and Tricks All participants are provided a Contract Pharmacy Designation Checklist

1. www.compliantfqhc.com
Navigating Manufacturer Designations for 340B
Contract Pharmacies
COMPLIATRIC WEBINAR SERIES
Presented by: Anita Miller
Director of Client Services
HIPAA Compliance Officer
RPh Innovations

4. Navigating Manufacturer
Designations for 340B
Contract Pharmacies

5. Introduction
Summary of 340B Manufacturer Changes
Challenges Faced When Designating
Real Case Scenario
Tips & Tricks
Conclusion
Overview

6. Introduction
July 2020, manufacturers challenged the 340B world with limiting
pricing for contract pharmacies and requesting data. Since then,
Covered Entities have seen large dip in estimated 340B Savings,
that has hindered their healthcare system.
Each manufacturer and the allotted designation of
pharmacies, has presented its own challenges
RPh Innovations (RPHI) has worked with over 18 Covered
Entities to prepare a plan of action, including recouping over
30% of the savings lost last quarter.

7. Summary of 340B
Manufacturer Changes

8. Eli Lilly
July 2020
• Cialis was removed from 340B pricing for all contract pharmacies and was now only available at a
discounted amount through Covered Entities and their Child Sites. It was communicated that if the
entity did not have an In-House Pharmacy, they should contact 340B@lilly.com.
September 2020
• 340B pricing was blocked for ALL contract pharmacies, with an exception for Insulin. If the entity did
not have an In-House Pharmacy, they could designate one contract pharmacy to receive pricing.
Limited Distribution for Insulin products, were handled differently.
• Designation Steps:
1. Fill out the 340B Limited Distribution Contract Pharmacy Selection Form, including an effective date.
2. Send the form to 340B@lilly.com requesting consideration of this designation.
3. Wait for approval from Eli Lilly
*Applies to all Entity types

9. Merck
June/July 2020
• Partnership with ESP (Second Sight Solutions) to obtain claims data bi-weekly from Covered
Entities to “match against rebate claims it receives to ensure it isn’t paying duplicate Medicaid
discounts…”
• Although, the participation from CE’s was listed as voluntary, Merck threatened to “take further
action” and gave entities a deadline of August 14th to register on the ESP portal.
August 2021
• September 1st, Merck products blocked at contract pharmacies for 340B Hospitals. Entities can
designate one pharmacy regardless of data submission. If data is submitted, entity can designate
an unlimited number of pharmacies so long as subsequent pharmacy data is uploaded to ESP.
• Designation Steps:
1. Register for a HIN at https://www.hibcc.org/hin-system/apply-for-a-hin/obtain-a-hin/
2. Register Entity and Designated pharmacy on 340B ESP Portal (www.340besp.com)

10. ESP Data Requirements
Data Specs:
1. Rx Number
2. Prescribed Date
3. Fill Date
4. NDC
5. Quantity
6. Pharmacy ID
7. Prescriber ID
8. Wholesaler Invoice Number
9. 340B ID
*File must be in Excel or CSV Format
*File must be submitted to ESP bi-weekly

11. Sanofi
July 2020
• Partnership with ESP (Second Sight Solutions) to obtain claims data bi-weekly from Covered
Entities to “match against rebate claims it receives to ensure it isn’t paying duplicate Medicaid
discounts…”
• Entities provided registration deadline of October 1, 2020.
February 2021
• Notification that Federal Grantees were exempt from blocks. CE’s with no outpatient, in-house
pharmacy can file for an exemption through ESP, to designate one contract pharmacy.
• Designation Steps:
1. Register for a HIN (required) at https://www.hibcc.org/hin-system/apply-for-a-hin/obtain-a-hin/
2. Register Entity and Designated pharmacy on 340B ESP Portal (www.340besp.com)

12. AstraZeneca
August 2020
• Notified all entities that as of October 1st, AstraZeneca products will no longer be supplied to
contract pharmacies at 340B pricing. This applies to all entity types.
• CE’s with no outpatient, in-house pharmacy can request an exemption and designate one contract
pharmacy.
• Designation Steps:
1. Submit letter (on Entity letterhead) to membership@astrazeneca.com
2. Letter should include the following information about your contract pharmacy:
1. Name 4. HIN (optional)
2. Address 5. 340B ID
3. Phone
* Recent change to the designation process
*One designation per Covered Entity Site registered on OPAIS.

13. Novartis
August 2020
• Partnership with ESP (Second Sight Solutions) to obtain claims data bi-weekly from Covered Entities to
“match against rebate claims it receives to ensure it isn’t paying duplicate Medicaid discounts…”
• Entities provided registration deadline of October 1, 2020.
• Register on www.340besp.com
• All entities will be required to submit claims data in order to keep receiving 340B pricing.
November 2020
• Notification to Hospital Covered Entities stating claims data was no longer a requirement and Novartis will
continue to provide 340B pricing to contract pharmacies, so long as the pharmacy is located within a 40
Mile radius of the Parent Site.
• Federal Grantees are exempt from this policy.

14. United Therapeutics
November 2020
• 340B contract pharmacy orders for United Therapeutic products placed on or after November 2020,
will be accepted ONLY if it occurred during the 1st full three quarters of the 2020 calendar year
(January-September 2020).
• CE can designate one contract pharmacy to receive 340B pricing, so long as the entity does not
have an outpatient, in-house pharmacy.
• Designation Steps:
1. Apply by contacting United Therapeutic Corporation at 340B@unither.com
• Any orders on or after May 2021, can only be purchased at 340B pricing if the entity has agreed to
submit claims data.

15. Novo Nordisk
December 2020
• Notified Hospital type entities that they will no longer support “bill-to/ship-to” arrangements at 340B
pricing, with contract pharmacies beginning January 2021.
• Federal Grantees are not impacted by this new policy.
• The Entity may designate one contract pharmacy to receive 340B pricing, so long as they do not
have an outpatient, in-house pharmacy.
• Designation Steps:
1. Complete Novo Nordisk exception form
2. Send request to 340binfo@novonordisk.com
3. HIN not required

16. Boehringer
July 2021
• Notified Hospital type entities that they will no longer ship products purchased at 340B pricing to
contract pharmacies, starting August 1, 2021.
• Federal Grantees are not impacted by this new policy.
• The Entity may designate one contract pharmacy to receive 340B pricing, so long as they do not
have an outpatient, in-house pharmacy.
• Designation Steps:
1. Register at www.340besp.com/designations

17. Challenges Faced When
Designating

18. Challenges Faced
• 20% decrease in 340B revenue leading to cutting of programs and/or staff
• Contract eligibility approval not reaching wholesaler (all manufacturers)
• Incorrect pricing (all manufacturers)
• Eli Lilly resolves pricing errors quicker than other manufacturers
• Inaccurate HIN listings on ESP

19. • Managing and directing communications between all parties (all manufacturers)
• Billing address vs. Shipping address causing pricing to change when it shouldn’t for
Entity owned pharmacies (all manufacturers)
• Flagging a pharmacy as “in-house” because of NPI (all manufacturers)
• TPA’s inability to restructure configuration for designations (Walgreens)
• Designations only allowed to be changed every 12 months (all manufacturers)
• Entities resources for data aggregation for ESP (Merck)
Challenges Faced

20. Real Case Scenario

21. A CAH applied for a HIN and then registers on 340B ESP. After 7 business days, the Entity receives the HIN and
designates the pharmacy on the ESP portal.
ESP approves the designation. After 2 weeks, the pricing is still not updated with 340B prices. RPHI discovered
that the HIN provided is incorrect and should not have been approved by ESP. Entity has to apply for a new HIN
number with HIBCC, taking an additional 7 business days. Once received, the pharmacy had to be “re-
designated.”
All products were excluded until it was confirmed that the designation was completed successfully, and pricing was
updated correctly.
The entity lost 20 days in product savings due to this error.
Example

22. Tips & Tricks

23. Suggestions
• Stay on top of communications to and from manufacturers… and follow up often!
• Include all parties (i.e., manufacturer, wholesaler, etc.) in your communications to resolve
inconsistencies.
• Make sure HIN is registered to pharmacy, not the entity
• If you believe the pharmacy already has one, confirm this with the wholesaler, not ESP.
• Double check your pricing.
• Work with your TPAs to confirm price files are correctly received.
• Complete a “lookback” with your TPA if possible.
• Make sure you know your costs if completing a lookback.
• Block NDCs at pharmacies that are not designated.

24. Lawsuits
Organization Action Date Additional Info.
RWC-340B [STAYED]
RWC-340B and 340B Grantee Plaintiffs File Lawsuit to Protect 340B Contract Pharmacy Program from Manufacturer Attacks That Are
Undermining Patient Care and Public Health
10/9/2020 First covered entity to initiate a lawsuit on this issue
Amended Complaint filed to add three covered entity plaintiffs: Little Rivers Health Care Inc. (Wells River, Vermont), FamilyCare Health
Center (Scott Depot, West Virginia), and Springhill Medical Center (Springhill, Louisiana)
11/23/2020
Temporary Restraining Order/Preliminary Inunction Filed 11/23/200
Asks Secretary of HHS to Immediately Enforce Covered
Entities' Rights Under 340B Statute
NACHC [STAYED] NACHC filed a lawsuit against HHS over implementation of the mandatory and binding administrative dispute resolution process 10/21/2020
American Hospital
Association [DISMISSED]
Five hospital associations, the association of hospital pharmacists, and three hospitals sued HHS over manufacturer actions 12/12/2020 Filed in Northern District of California
Drug Manufacturers
Drug Manufacturers Eli Lilly, AstraZeneca, Sanofi, Novartis, Novo Nordisk, and United Therapeutics sue HHS regarding HHS Advisory Opinion,
ADR Final Rule, May 17 Letter (all separate lawsuits)
PhRMA Filed lawsuit regarding final ADR Rule. 1/22/2021 Filed in Maryland Federal District Court

25. Conclusion

26. Conclusion
While we are unsure of where the future lies with manufacturers
and 340B, we can assume it will not be dismissed quickly.
It is important for your Covered Entity to take the necessary steps
to designate pharmacies and follow the appropriate steps in
attempt to recoup savings or create a plan of action for
alternative opportunities.

27. Questions?
Anita Miller
Director, Client Services
HIPAA Compliance Officer
630-963-0024
amiller@rphinnovations.com