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July 27, 2012 

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Murer Consultants, Inc. 

 

Cherilyn G. Murer, JD, CRA 

President/CEO 

cmurer@murer.com

 

Michael A. Murer, JD 

Executive Vice President 

mmurer@murer.com

 

Lyndean L. Brick, JD

Senior Vice President 

lbrick@murer.com

  

58 North Chicago Street

7th Floor

Joliet, Illinois 60432

(815) 727-3355

Fax:  (815) 727-3360  

HRSA Announces Major Change  

to 340B Registration  

 

Please be advised that the Health Resources and Services Administration (HRSA), Office of Pharmacy Affairs (OPA) recently issued a new policy on July 24, 2012 that significantly changes the registration deadlines for covered entities and contract pharmacies that participate in the 340B Drug Pricing Program (340B).

 

Effective October 1, 2012, covered entities must complete 340B registrations - including the provision of required additional documentation - within the new registration periods listed below.

 

Registration Periods for New Covered Entities  

and Covered Entity Outpatient Facilities

 

Registration Period

Start Date

January 1 - January 15

April 1

April 1 - April 15

July 1

July 1 - July 15

October 1

October 1 - October 15

January 1

 

Note: Supporting documentation must be submitted via the online process on the same day as the registration application (includes cost reports, contracts, signed certifications, etc.). Failure to submit all documents on the same day will render the application incomplete.

 

Registration Periods for Contract Pharmacies

 

Registration Period

Start Date

January 1 - January 15

April 1

April 1 - April 15

July 1

July 1 - July 15

October 1

October 1 - October 15

January 1

 

Note: A completed, signed, original copy of the contract pharmacy registration form must be submitted to OPA within 15 days from the time online registration was completed. Failure to do so will render the contract pharmacy registration process incomplete and may prevent the contract pharmacy from dispensing 340B drugs until the next applicable quarter.


Key Take-Aways
  1. Timing of new 340B sites must be carefully considered when developing new eligible locations or when executing contract pharmacy agreements.
  2. 340B registration deadlines change October 1, 2012 for covered entities, covered entity outpatient facilities, and contract pharmacies.
  3. 340B registration process must be completed within a 15-day window that ends approximately 75 days before the effective date of the registration.
  4. Covered entities and outpatient facilities must submit supporting documentation on the same day as the underlying registration.
  5. Contract pharmacies have 15 days from the date of submission of the underlying 340B application to submit a signed registration form.

Over the past few years, Murer Consultants, Inc. has worked extensively in this area.  Please contact us if you have any questions regarding the 340B implementation, strategic development, registration process and/or deadlines, eligibility, or program audits.

  

We will be happy to assist you.

  

Murer Consultants