2006 proposed fee schedule - American Society of Clinical Oncology

current reporting format is an approved information
collection. The OMB control number is 0938-0921.
f. Limitations on ASP
Section 1847A(d)(1) of the Act states that “the
Inspector General of the Department of Health and Human
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Services shall conduct studies, which may include surveys to
determine the widely available market prices of drugs and
biologicals to which this section applies, as the Inspector
General, in consultation with the Secretary determines to be
appropriate.” Section 1847A(d)(2) of the Act states that
“Based upon such studies and other data for drugs and
biologicals, the Inspector General shall compare the ASP
under this section for drugs and biologicals with –
• The widely available market price for such drugs and
biologicals (if any); and
• The average manufacturer price (as determined under
section 1927(k)(1) for such drugs and biologicals.”
Section 1847A(d)(3)(A) of the Act states that “The
Secretary may disregard the ASP for a drug or biological
that exceeds the widely available market price or the
average manufacturer price for such drug or biological by
the applicable threshold percentage (as defined in
subparagraph (B)).” The applicable threshold is specified
as 5 percent for CY 2005. For CY 2006 and subsequent years,
section 1847A(d)(3)(B)of the Act establishes that the