Possible Solution for Identifying 340B Drugs and non340B Drugs on the Same Claim Form 340B Coalition

1
Possible Solution for Identifying 340B Drugs
and non-340B Drugs on the Same Claim Form 340B
Coalition Winter Conference January 31, 2008

• Alan Shugart
• Division of State Systems
• CMS

2
Deficit Reduction Act (DRA) FFP Conditions
related to Physician- Administered Drugs (PAD)

• The DRA included a provision that no Federal
  Financial Participation (FFP) would be available
  to Medicaid Programs for physician-administered
  drugs for which a State has not required the
  submission of claims using codes that identify
  the drugs sufficiently for the State to bill a
  manufacturer for rebates with certain
  requirements

3
Deficit Reduction Act (DRA) FFP Conditions
related to Physician- Administered Drugs (cont)

• As of 1/1/2006 States must require provider to
  submit claims for single source PAD using HCPCS
  or NDC to secure rebates
• As of 1/1/2008 States must require provider to
  submit claims for the 20 multiple source PAD
  identified by the HHS Secretary using NDC

4
Deficit Reduction Act (DRA) FFP Conditions
related to Physician- Administered Drugs (cont)

• As of 1/1/2007 States must require provider to
  submit claims for PAD single source and the 20
  multiple source drugs identified by the Secretary
  using NDC
• A State that requires additional time to comply
  with the requirements may apply for an extension

5
Paper Billing Issues

• In order to implement the DRA National Uniform
  Claim Committee (NUCC) for the CMS-1500 and the
  National Uniform Billing Committee (NUBC) for the
  UB-04 had to establish location and instructions
  for billing the NDC in addition to the HCPCS or
  Revenue Code

6
Paper Billing Issues

• Both the NUCC and the NUBC have identified the
  suggested general location and instructions for
  each form
• Fortunately the HIPAA 837 I (Institutional) and
  HIPAA 837 P (Professional) already allowed the
  billing of the NDC so that was not an issue

7
Potential 340B Billing Issue

• As part of the development work with the NUBC and
  the Office of Pharmacy Affairs Medicaid
  Exclusion Workgoup it was discovered that
  providers participating in the 340B program do
  not necessarily purchase all drugs through the
  program and therefore both could be billed on the
  same claim

8
Potential 340B Billing Issue

• Options were considered on how to to identify
  340B drugs and non-340B drugs billed on the same
  claim
• Most options initially discussed did not work
  because they applied to the full claim and could
  not differentiate 340B drugs and non-340B drugs
  and were rejected

9
Possible Solution to the 340B Billing Issue

• Due to the tight implementation time frame
  options that would have to go through external
  approval processes, such as changes to the forms,
  HIPAA standards or new codes, were rejected
• A solution has been identified using an existing
  HCPCS modifier that is defined by the State
  Medicaid Program

10
Possible Solution to the 340B Billing Issue

• The U series of HCPCS modifiers are defined by
  the State Medicaid Program.
• It has been recommended to the National Medicaid
  EDI Healthcare (NMEH) to use the UD modifier

11
Possible Solution to the 340B Billing Issue

• The UD modifier can be billed on the CMS 1500
  837 P and the UB-04 837 I, linked to the HCPCS
  and NDC and allows each drug to be identified as
  340B or non-340B
• The UD modifier may still require to be
  approved through the States regulatory processes.