| Date Issued | Manufacturer | Hyperlinks | Summary of Action Taken | Effective Date/Deadline | Exceptions for Certain Covered Entities | Consequences | Additional Information |
|---|---|---|---|---|---|---|---|
| 07-01-2020 | Eli Lilly | Limited Distribution Plan published on the HRSA website | See summary here. | Effective Date: July 1, 2020 | Covered entities that do not have an in-house pharmacy should contact 340B@lilly.com regarding an exception process. | N/A - Applies to all CEs | |
| 06-29-2020 | Merck Sharpe & Dohme Corp. | Letter to CEs | See summary here. | Registration deadline: August 14 | No exceptions. | Registration is "voluntary" & Merck will take “less collaborative, and substantially more burdensome” action if too few covered entities voluntarily provide the data. Merck may audit CE, but unclear if it will deny requests for 340B discounts. | Letter from Merck in response to letters from CEs |
| July | Sanofi | Letter to CEs | See summary here. | Registration deadline: October 1 | NEW LESS-RESTRICTIVE APPROACH (Feb) Federal grantees exempted. Only consolidated health center programs, disproportionate share hospitals, critical access hospitals, rural referral centers, and sole community hospitals are required to submit claims through 340B ESP. CEs that do not have an in-house pharmacy to designate one contract pharmacy. | Sanofi will not provide 340B discounts through contract pharmacies for its products. | |
| 08-17-2020 | Astra-Zeneca | Letter to covered entities | Will not provide 340B discounts through contract pharmacies for its products. AZ will honor one contract pharmacy arrangement for those CEs that do not "maintain their own on-site dispensing pharmacy" | Effective date: October 1 | Astra-Zeneca will honor one contract pharmacy arrangement for those CEs that do not "maintain their own on-site dispensing pharmacy". These CEs should contact membership@AstraZeneca.com. | N/A - Applies to all CEs | In a letter to wholesalers, Astra-Zeneca stated that it will honor 340B pricing on all chargeback invoices prior to October 1, “but AstraZeneca asks for the removal of contract pharmacy eligibility prior to or by the end of business September 30, 2020.” |
| 08-17-2020 | Novartis Pharmaceuticals | Letter to CEs | See summary here. | Registration deadline: October 1 | No exceptions. | The letter states that CEs must “provide 340B claims data originating from [contract pharmacy] utilization in order to receive 340B reimbursements from Novartis.” This suggests that Novartis will not provide 340B discounts through contract pharmacies for its drug products. | |
| 10-30-2020 | Novartis Pharmaceuticals | Letter to covered entities | See summary here. | New policy effective Nov. 16, 2020 | If a hospital does not own its own pharmacy and will be left with no contract pharmacy, Novartis will "work with the affected institution to ensure it has appropriate access to a contract pharmacy." NEW LESS-RESTRICTIVE APPROACH: Novartis states that it will not honor contract pharmacy agreements that are located outside of a 40-mile radius of the parent site. | NEW LESS-RESTRICTIVE APPROACH: Novartis states that it will not honor contract pharmacy agreements that are located outside of a 40-mile radius of the parent site. Novartis still encourages all covered entities to voluntarily upload their claims data to the 340B ESP platform, “in an effort to increase transparency, mitigate instances of duplicative discounts and maintain the integrity and sustainability of this vital [340B] program.” | |
| 08-27-2020 | N/A | 340B Pay Platform Website | Launching “340B Pay” platform which would transform 340B discount program into a "rebate program" by shifting a manufacturer’s responsibility from providing a 340B discount at the point of sale to paying a rebate after the drug is purchased, dispensed, and billed. | Launch date: September 8 | N/A | N/A | |
| 09-01-2020 | Eli Lilly (including subsidiaries and affiliates) | Limited Distribution Plan Notice for Eli Lilly and Company Products | See summary here. | Effective September 1, 2020 | Covered entities that do not have an in-house pharmacy should contact 340B@lilly.com regarding an exception process. "Special exception" made for Lilly insulin products so long as the following "conditions" are met: (1) 340B price at point of sale, (2) no mark-ups or dispensing fees, (3) no insurer or payer is billed for the drug (4) CE provides claims level data to demonstrate compliance. CEs must contact 340B@lilly.com to take advantage of insulins exception and provide supporting documentation. | N/A - Applies to all CEs. | In general, all Limited Distribution Plans are posted on the HRSA website. This LDP has not been posted. |
| 11-18-2020 | United Therapeutics Corporation | Letter to CEs | UT sent letters to CEs with additional information about phase 2 on April 12.ps://www.rwc340b.org/novo-nordisk-and-united-therapeutics-are-the-latest-drug-manufacturers-to-limit-access-to-340b-prices-at-contract-pharmacies/">See summary here. | Phase 1: November 20, 2020 Phase 2: May 13, 2021 | CEs that do not have an on-site outpatient pharmacy may designate a signle contract pharmacy for which United Therapeutics will honor 340B prices. Permitted contract pharmacies limited to those chosen by United Therapeutics - https://www.utassist.com/hcp/ (select Our Services/Product Distribution). | On or after May 13, 2021, CEs that do not submit claims data will be denied 340B prices at contract pharmacies. UT will no longer allow CEs to disignate one contract pharmacy to receive drugs at 340B prices. | |
| 11-18-2020 | Novo Nordisk | Notice Regarding Limitation on Hospital Contract Pharmacy Distribution | See summary here. | Beginning January 1, 2021 | If a “hospital” covered entity does not have an in-house pharmacy capable of dispensing product to outpatients, that covered entity may designate one contract pharmacy location to which product purchased by that covered entity may be shipped. | N/A applies to all hospital covered entities. |
| 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 | 10-09-2020 | First covered entity to initiate a lawsuit on this issue |
| RWC-340B (STAYED) | 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 | |
| RWC-340B (STAYED) | Temporary Restraining Order/Preliminary Inunction Filed | 11-23-2020 | 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, and Novo Nordisk sue HHS over HHS Office of General Counsel Advisory Opinion | 01-12-2021 | Lilly filed in Indiana, Sanofi and Novo Nordisk filed in New Jersey, and AstraZeneca filed in Delaware |
| Drug Manufacturers | Drug Manufacturers Eli Lilly, AstraZeneca, Sanofi, and Novo Nordisk sue HHS over HHS Office of General Counsel Advisory Opinion | 03-16-2021 | US District Court for the Southern District of Indiana Grants Lilly’s Motion to Halt 340B Dispute Resolution System |
| PhRMA | PhRMA files a lawsuit against HHS over the ADR Final Rule and manufacturer audit guidelines. | 01-22-2021 | Filed in Maryland Federal District Court |
| Organization | Action | Date |
|---|---|---|
| Open Door Health Clinic | Powers filed an ADR Petition on Behalf of Open Door Against AstraZeneca | 1-13-21 |
| NACHC | NACHC filed a joint ADR Petition on behalf of its members against Eli Lilly, AstraZeneca, and Sanofi | 1-13-21 |
| HRSA | HRSA sends emails to counsel to nofity that ADR petitions are deemed "complete" | 3-23-21 |