Crosswalk

Eligibility of Drugs, Biologicals, and Radiopharmaceuticals for
Transitional Pass-Through Status under the Hospital Outpatient
Prospective Payment System (OPPS)
Change Crosswalk
Original Drug Application Changes to Drug Application

Explanation

Burden Effect

Process and Information
Required to Determine
Drugs, Biologicals, and
Radiopharmaceutical Agents,
Eligible for Transitional PassThrough Provisions Under
the Hospital Outpatient
Prospective Payment System
(OPPS) Page: 1 of 4

The subtitle was
removed because it
duplicated the
main title. Two
titles were not
necessary.

N/A

Removed the word
non-implantable
and agents for
clarification on the
past thru-drug
application.

N/A

This note was
removed because it
contained outdated
language.

N/A

Process and Information
Required to Determine
Eligibility of Drugs, NonImplantable Biologicals,
and Radiopharmaceutical
Agents for Transitional
Pass-Through Status
Under the Hospital
Outpatient Prospective
Payment System (OPPS)
Please note: Effective
January 1, 2010,
implantable biologicals that
are surgically inserted or
implanted (through a
surgical incision or natural
orifice) will be evaluated for
device pass-through
payment under the
instructions using the device
pass-through process. For
the processes and
information required to
apply for designation of
New Technology services
or new pass-through
device categories go to the
main OPPS web page,
currently at
http://www.cms.hhs.gov/Ho
spitalOutpatientPPS/Downl
oads/catapp.pdf to see the
latest instructions. (NOTE:
Due to the continuing
development of the new
cms.hhs.gov web site, this
link may change.)

Process and Information
Required to Determine
Eligibility of Drugs, Biologicals,
and Radiopharmaceuticals for
Transitional Pass-Through
Status under the Hospital
Outpatient Prospective
Payment System (OPPS)

Page 1 of 13

This announcement
describes in detail the
process and information
required for applications
requesting transitional passthrough payment for drugs,
non-implantable biologicals,
and radiopharmaceutical
agents under the Medicare
hospital outpatient
prospective payment system
(OPPS). These instructions
apply solely to requests
submitted on or after
January 1, 2010 for
transitional pass-through
status for drugs, nonimplantable biologicals, and
radiopharmaceuticals.
Because CMS intends to
make information used in
the rate setting process
under the OPPS available
to the public for analysis,
applicants are advised that
any information submitted,
including commercial or
financial data, is subject to
disclosure for this purpose.

This announcement describes in
detail the process and information
required for applications
requesting transitional passthrough payment for drugs,
biologicals, and
radiopharmaceuticals under the
Medicare hospital outpatient
prospective payment system
(OPPS).

Removed the word
N/A
non-implantable and
agents to clarify the
pass thru-drug
application. This note
was removed because
it contained outdated
language.

.

This note was
removed
because it
contained
outdated
language.

We will accept transitional
pass-through applications
for drugs, non-implantable
biologicals, and
radiopharmaceutical agents
on an ongoing basis.
However, we must receive
applications sufficiently in
advance of the first calendar
quarter in which transitional
pass-through status is
sought to allow time for
analysis, decision-making,
and computer programming.
The table below indicates
the earliest date that passthrough status could be
implemented once a
completed application and
all additional information
are received.

We will accept transitional passthrough applications for drugs,
biologicals, and
radiopharmaceuticals on an
ongoing basis. 1 However, we
must receive applications
sufficiently in advance of the
first calendar quarter in which
transitional pass-through status is
sought to allow time for analysis,
decision making, and computer
programming. The table below
indicates the earliest date that
pass-through status could be
implemented once a completed
application and all additional
information are received.

Removed the word N/A
non-implantable
and agents to
clarify the pass
thru-drug
application. This
footnote was added
to clarify the pass
thru-drug
application.

N/A

1 CMS intends to make
information used in the
ratesetting process under the
OPPS available to the public for
analysis therefore applicants are
advised that any information
submitted, including commercial
or financial data, is subject to
disclosure for this purpose.

Page 2 of 13

Process and Information
Required to Determine
Drugs, Non-Implantable
Biologicals, and
Radiopharmaceutical
Agents, Eligible for
Transitional Pass-Through
Provisions Under the
Hospital Outpatient
Prospective Payment System
(OPPS) Page: 2 of 4

.

This subtitle was
removed on the
updated application.

N/A

Section 1833(t)(6) of the Social
Security Act provides for
temporary additional payments or
“transitional pass- through
payments” for certain drugs and
biological agents. As originally
enacted by the Balanced Budget
Refinement Act of 1999 (BBRA),
this provision required the
Secretary to make additional
payments to hospitals for current
orphan drugs, as designated under
section 526 of the Federal Food,
Drug, and Cosmetic Act (Pub. L.
107-186); current drugs and
biological agents and
brachytherapy sources used for the
treatment of cancer; and current
radiopharmaceutical drugs and
biological products.

We defined the
acronym.
We deleted
outdated
language
contained on the
application.

N/A

Background
Section 1833(t)(6) of the
Act provides for temporary
additional payments or
―transitional pass-through
payments‖ for certain drugs
and biological agents. As
originally enacted by the
BBRA, this provision
required the Secretary to
make additional payments
to hospitals for current
orphan drugs, as designated
under section 526 of the
Federal Food, Drug, and
Cosmetic Act (Pub. L. 107186); current drugs and
biological agents and
brachytherapy used for the
treatment of cancer; and
current radiopharmaceutical
drugs and biological
products. For those drugs
and biological agents
referred to as ―current,‖ the
transitional pass-through
payment began on the first
date the hospital OPPS was
implemented (before
enactment of BIPA (Pub. L.
106-554), on December 21,
2000).

Page 3 of 13

Transitional pass-through
payments are also provided for
certain ―new‖ drugs, devices and
biological agents that were not
being paid for as a hospital
outpatient department service as
of December 31, 1996, and whose
cost is ―not insignificant‖ in
relation to the OPPS payment for
the procedures or services
associated with the new drug,
device, or biological. Under the
statute, transitional pass-through
payments can be made for at least
2 years but not more than 3 years.
Transitional pass-through
payments for drugs and
biologicals under the OPPS are
discussed in the final rule
published in the April 7, 2000
Federal Register (65 FR 18478),
and in subsequent OPPS rules and
issuances, which can be found at,
http://www.cms.hhs.gov/Hospital
OutpatientPPS/HORD/list.asp#To
pOfPage,
http://www.cms.hhs.gov/MLNMatt
ersArticles/, and
http://www.cms.hhs.gov/Manuals/.

Transitional pass-through
We deleted the old
N/A
payments are also provided for
hyperlink and updated
certain “new” drugs, devices and the hyperlink to the
biological agents that were not paid correct website.
for as a hospital outpatient
department service as of December
31, 1996, and whose cost is “not
insignificant” in relation to the
OPPS payment for the procedures
or services associated with the new
drug, device, or biological. Under
the statute, transitional passthrough payments can be made for
at least 2 years but not more than 3
years. Transitional pass-through
payments for drugs and biologicals
under the OPPS are discussed in
the final rule published in the April
7, 2000 Federal Register (65 FR
18478), and in subsequent OPPS
rules and issuances, which can be
found at
http://www.cms.gov/Medicare/Me
dicare-Fee-for- ServicePayment/HospitalOutpatientPPS/H
ospital-Outpatient-Regulationsand-Notices.html;
http://www.cms.gov/Outreach-andEducation/Medicare-LearningNetworkMLN/MLNMattersArticles/index.h
tml?redirect=/MLNMattersArticles
/; and
http://www.cms.gov/RegulationsandGuidance/Guidance/Manuals/index
.html?redirect=/Manuals/.

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Section 1833(t)(6)(D)(i) of
the Act sets the payment
rate for pass-through
eligible drugs and
biologicals (assuming that
no pro rata reduction in
pass-through payment is
necessary) as the amount
determined under section
1842(o) of the Act. Section
303(c) of Pub. L. 108-173
amended Title XVIII of the
Act by adding new section
1847A. This new section
establishes the use of the
average sales price (ASP)
methodology for payment
for drugs and biologicals
described in section
1842(o)(1)(C) of the Act
furnished on or after
January 1, 2005. Payment
for OPPS pass-through
drugs and biologicals is set
at the rate under the
Competitive Acquisition
Program (CAP) for Part B
drugs or, if the drug is not
included in the CAP, at the
rate established by the ASP
methodology. For CY
2011, payment rates will
be established under ASP
methodology. Under the
hospital OPPS,
radiopharmaceuticals are
considered drugs for passthrough purposes. For CY
2011, payment for
diagnostic and therapeutic
radiopharmaceuticals that
are granted pass-through
status will be based on the
ASP methodology.
The most current list of the
drugs and biologicals that
are separately paid under the
OPPS, along with their
payment rates, can be found
in the most recent quarterly
update of Addendum B,
located at
http://www.cms.hhs.gov/Ho
spitalOutpatientPPS/AU/list
.asp#TopOfPage.
Information on Average
Sales Price is found at
http://www.cms.hhs.gov/Mc
rPartBDrugAvgSalesPrice/.

The following products are not
We deleted outdated N/A
eligible to apply for transitional
language and replaced
pass-through payments through this it with clarifying
drug, biological and
language.
radiopharmaceutical pass-through
application process and instead must
apply through the device transitional
pass- through application process:
1. Implantable biologicals
(regardless of Food and Drug
Administration [FDA] approval or
clearance type)
2. Skin substitutes and similar
products that aid wound healing
(regardless of FDA approval or
clearance type)
3. Any product approved or cleared
by the FDA as a medical device
except for viscosupplements for
osteoarthritis.

Page 5 of 13

Required Information
h. How dosages are
measured.

h. How dosages are measured.
We added clarifying N/A
i. For drugs and biologicals other
language to the pass
than contrast agents or
thru-drug application.
radiopharmaceuticals, specify how
dosages are measured, e.g., in
milligrams, micrograms, etc.
ii. For diagnostic and therapeutic
radiopharmaceuticals and for
contrast agents, specify the
following information: A. Indicate
whether the product is available in
milligrams (mg), millicuries (mCi),
or microcuries (uCi), including
concentration before and after
reconstitution.
B. If the Average Wholesale Price
(AWP) (or other price) is stated “per
vial” or "per ampule," indicate how
many doses can be administered
from one vial or one ampule.
C. If the AWP (or other price) is
stated “per dose,” "per vial," or "per
ampule," but the item is
administered in milligrams (mg),
millicuries (mCi), or microcuries
(uCi), indicate how many mg, mCi,
or uCi are in one dose, one vial
and/or one ampule.

3. A copy of the most
recently published average
wholesale price (AWP)
and/or wholesale acquisition
cost (WAC), including the
date of publication and
compendium where
published (examples include
Red Book® and MediSpan®). NOTE: Applicants
may be responsible for
updating their compendia
submission prospectively.

3. A copy of the most recently
We deleted the word N/A
published AWP and Wholesale
or and we added
Acquisition Cost (WAC), including clarifying language to
the date of publication and
the drug application.
compendium where published
(please include either RED BOOK™
or Medi-Span Price Rx among the
compendium in which the price is
published). Note – the price
submitted by the application
deadline (which is subject to
verification by CMS) will be used
for initial determination of passthrough payment. No price updates
after the application deadline will
be accepted. If the applicant has not
determined the price by the
application deadline or if the
applicant wants to update the price
after the application deadline, then
the applicant must withdraw the
application and reapply for passthrough in a subsequent quarter.

Page 6 of 13

6. The actual market date or
date of sale of first unit.
NOTE: If a drug is pending
imminent FDA approval,
indicate estimated FDA
approval date and
anticipated date of sale of
first unit.

6. The date of commercial market
availability or date of sale of first
unit.

We deleted the old
N/A
language and replaced
it with clarifying
language to make the
drug application more
effective.

7. List the Healthcare
Common Procedure Coding
System (HCPCS) code(s)
associated with the product.
a. CPT or Level II
alphanumeric HCPCS code
that reflects the procedure
code(s) associated with the
product’s use (e.g.,CPT
codes for drug
administration, etc.).
b. Level II alphanumeric
HCPCS code that
specifically identifies the
product/item (if available).
Specifically, list the Ccode, J-code, Q-code, or
any other Level II
alphanumeric HCPCS code
that appropriately describes
the item,
(NOTE: APPROVAL OF
A DRUG OR
BIOLOGICAL FOR A
TRANSITIONAL PASSTHROUGH PAYMENT
UNDER THE OPPS IS
NOT CONTINGENT ON
PRIOR ASSIGNMENT
OF A NATIONAL
HEALTHCARE
COMMON PROCEDURE
CODING SYSTEM
CODE.). If no HCPCS
code is currently available,
please specify the
requested code descriptor,
including dosage units.

Under subsection A. we N/A
7. List the Healthcare Common
Procedure Coding System (HCPCS) deleted the example of
code(s) associated with the product. CPT codes for drug
a. CPT or Level II HCPCS code that administration and we
added the word drug
reflects the drug administration
administration. We then
procedure code(s) or other
added or other procedure
procedure code associated with the code to help clarify the
product.
drug application.
b. Level II HCPCS code that
Under subsection B. we
currently identifies the product/item, deleted the word
including an unlisted HCPCS code specifically and replaced
it with currently. We
(e.g., A, C, J, or Q code). Note:
Approval of a drug, biological or also deleted the (if
available). Specifically,
radiopharmaceutical for a
list the C-code, J-code,
transitional pass-through payment Q-code, or any other
under the hospital OPPS is not
Level II alphanumeric
contingent on prior assignment of HCPCS code that
a national HCPCS code. If no
appropriately describes
the item, and replace it
HCPCS code is currently
with including an
available, please specify the
unlisted HCPCS code
requested code descriptor,
(e.g., A, C, J, or Q code).
including dosage units.
We also added or
radiopharmaceutical .

Page 7 of 13

10. A copy of the package insert.

10. A copy of the FDA label
(package insert).

Added the word FDA N/A
label to the drug
application.

11. For non-implantable biological
application(s), a copy of the United
States Pharmacopeia (USP)
Monograph for the product is
required if it has not received FDA
approval as a biological.

This language was
N/A
removed because it
doesn’t apply to the
drug applications any
longer. As a result of
deleting number 11,
numbers 12 and 13
moves from the old
form up to numbers
11 and 12 on the
revised form.

Process and Information Required
to Determine Drugs, NonImplantable Biologicals, and
Radiopharmaceutical Agents,
Eligible for Transitional PassThrough Provisions Under the
Hospital Outpatient Prospective
Payment System (OPPS) Page: 4 of
4

This subtitle was
removed.

IN ADDITION, answer 13A. or
13B., whichever is applicable.
13A. For drugs and nonimplantable biologicals OTHER
THAN contrast agents or
radiopharmaceutical products,
specify how dosages are
measured, i.e., in milligrams,
micrograms, etc.
13B. For diagnostic and
therapeutic radiopharmaceutical
drugs and for contrast agents,
specify the following information:
a. Indicate whether the product is
available in milligrams (mg),
millicuries (mCi), or microcuries
(uCi), including concentration
before and after reconstitution.
b. If the AWP is stated ―per vial‖
or "per ampule," indicate how
many doses can be administered
from one vial or one ampule.
c. If the AWP is stated ―per
dose,‖ "per vial," or "per ampule,"
but the item is administered in
milligrams (mg), millicuries
(mCi), or microcuries (uCi),
indicate how many mg, mCi, or
uCi are in one dose, one vial
and/or one ampule.

N/A

This section was
N/A
removed and added
to section 2 h. ii C.
The removal and
placement in that
section added more
clarity to the drug
application.

Where to send
applications

Page 8 of 13

Because of staffing and
resource limitations, we
cannot accept applications
by facsimile (FAX)
transmission or by e-mail.
Mail six (6) copies of each
completed application to the
following address:

Send three hard copies and one
electronic copy of each
completed application with all
supporting information to the
following address and e-mail
address:

Questions pertaining to the
pass-through payment
application process for
drugs, non-implantable
biologicals or
radiopharmaceutical agents
may be sent via e-mail to
the Division of Outpatient
Care mailbox,
[email protected]
v, or by phone to 410-7860378.

[email protected] The hyper link was N/A
added to the revised
Questions pertaining to the pass- drug application and
through payment application
the word nonprocess for drugs, biologicals or implantable was
radiopharmaceuticals may be
deleted. We also
sent via e-mail to
revised the
[email protected] application the
or by phone to 410-786-7267.
updated drug
application email
address and revised
phone number.

We deleted the old N/A
language and
replace it with more
clarifying language

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