CMS has issued an educational article on "Food and Drug Administration Approval of First Biosimilar Product," and the implications for Medicare coverage. CMS states that its policies "will ensure Medicare beneficiaries will have access to this new product, as it does for other drugs that receive FDA approval." The document includes the following Q&A:
Question: How will a
health care professional that administers this product get
reimbursed under Medicare Part B?
Answer: Medicare Part B payment for newly approved
drugs and biologicals is available once the product is approved by
the FDA. CMS will incorporate biosimilars that are approved under
the abbreviated biological approval pathway into the Average Sales
Price (ASP) payment methodology, and issue additional guidance as
necessary. Initially, once the manufacturer's wholesale
acquisition cost (WAC) is available, Medicare will pay 106 percent
of the WAC for the product until ASP information is available. Once
ASP information is available for this biosimilar product, Medicare
payment will equal the ASP for the biosimilar product plus six
percent of the ASP for the reference product.
Question: How soon
will CMS be releasing coding information related to Part B
reimbursement?
Answer: CMS anticipates including the approved
biosimilar in the next quarterly Healthcare Common Procedure Coding
System (HCPCS) tape release in the coming weeks, appearing in the
claims processing system on July 1, 2015, effective retroactively
to the FDA approval date.
Question: Will CMS be
assigning unique codes to each biosimilar released?
Answer: CMS will create a separate code to
distinguish the biosimilar from the reference biological. CMS is
considering policy options for coding of additional biosimilars,
and will release further guidance in the future.
Question: Will use of
a distinguishing identifier to biological products make it harder
to achieve Medicare reimbursement?
Answer: Distinguishing identifiers will have no
bearing on coding and payment.
Question: How will
CMS address providing access to biosimilars through Medicare Part
D?
Answer: Although coverage for filgrastim will
generally be provided through Part B, it could also be covered
under Part D in certain circumstances (for example, nursing homes
or Intermediate Care Facilities for Individuals with Intellectual
Disabilities (ICF/IID)). CMS will be releasing guidance to plans
confirming that biosimilars approved by the FDA will be subject to
existing rules for prescription drugs under Part D.
To read the full article, click here.
This article is presented for informational purposes only and is not intended to constitute legal advice.