Instructions and Definitions
These instructions are for a data sheet that provides
a financial overview of the Factor Replacement Product
(FRP) operations of HRSA-funded Hemophilia Treatment
Centers (HTCs) that purchase FRP at prices mandated
by section 340B of the Public Health Service Act and
or purchase FRP outside of the 340B program. The data
sheet is meant to provide a summary picture of the scope
of the FRP program(s) operating during the most recent
budget period including indicators of programmatic and
financial benefits.
Each HTC having a FRP Program is to submit a data sheet
to the applicable Hemophilia Regional Grantee for submission
to the Project Officer at HRSA’s Maternal and
Child Health Bureau (MCHB) as a part of the Hemophilia
Regional Grantee's annual application (either competitive
or continuation). It is acceptable to identify a HTC
either by name or by a designated letter (Item 1).
For “Reporting period“ enter the starting
and ending dates for your most recent completed grant
budget period. Those dates should correspond to the
dates on your most recent financial status report (Item
2).
The first section of the data sheet (“Patient
Data”) is for providing information on the patients
served by the HTC's FRP program. The data are to be
broken down between those receiving 340B priced FRP
and those receiving non-340B FRP. Only those HTCs that
have elected to carve out Medicaid from their FRP
program should complete line 6, "Medicaid patients
receiving NON-340B FRP from HTC. Forms cannot have numbers
in both Medicaid lines unless the HTC changed the election
within the reporting period (Items 3-7).
For purposes of this form, in counting the number of
individuals, please define an individual as a “Medicaid
patient” in a manner consistent with your reporting
for your Medicaid or Medicare cost report. If no such
definition exists, define a “Medicaid patient”
as someone who qualified for Medicaid services for six
months or more of the reporting year. Please ensure
that you do not double count. That is, be careful not
to include the same individual as a “Medicaid
patient” as well as a non-Medicaid patient (Items
4-6).
For "Balance at start of reporting period"
enter the amount of unspent funds from previous FRP
collections as of the beginning of the reporting period
(Item 9).
For the Revenue items on the form, the actual receipts
from the sale of FRP and other related products to HTC
patients should be entered whether received by the HTC
directly or by the parent organization. Sales to non-HTC
patients should not be included in this report. Note:
Provisions under the 340B program allow HTCs to purchase
FRP at a non-340B price for their Medicaid patients
if they so choose. This is referred to as the Medicaid
Carve out. An HTC having a 340B program is not allowed
to purchase factor for its patients, other than its
Medicaid patients, at a non-340B price (Items 11 and
12).
For the Cost of FRP items on the form, the total amounts
paid for FRP acquisitions based on pharmacy ordering
and inventory records should be entered (Items 15 and
16).
For the cost of pharmacy staff (Item 17) enter an estimate
of that part of the salaries and benefits for staff
that operate or support the pharmacy that is attributable
to the FRP program(s). This can include both staff that
work in the pharmacy and staff at the HTC who work directly
on the FRP program. If your pharmacy is not dedicated
100% to the distribution of FRP, then make sure you
enter only that portion of a pharmacy staff member’s
salary and benefits that are attributable to the FRP
program. Provide an estimate of the percentage of time
the individual spends on the FRP program versus his/her
other responsibilities. This is also important for HTC
staff working on the FRP program. For example, if someone
at your HTC is responsible for taking FRP orders but
also has other responsibilities at the HTC, only the
percentage of that person’s salary and benefits
which equates to the amount time spent taking orders
should be reported in this line. NOTE: Staff supported
100% by the grant cannot simultaneously be included
as a cost to the FRP program nor can an individual’s
effort be more than 100% between grant support and as
a cost to the FRP program (Item 17).
For "Cost of contractual services," enter
the amount of any contractual pharmacy services attributable
to the FRP program(s) (Item 18).
For "Other direct costs," identify and enter
any other direct costs attributable to FRP program operations,
for example, equipment, supplies, shipping, insurance,
etc. (Item 19).
“Total FRP Operating Costs” is the total
amount for purchasing FRP plus the total for all of
the other operating costs (Item 13).
"FRP Program net income" is the difference
between FRP revenue received and FRP operating costs.
This number is your program income generated by the
FRP program (Item 20).
"Use of Program Income" is a breakdown of
how available resources from the HTC FRP program are
used. According to 45 CFR 74.24 (b) (1), program income
must be used to further eligible project or program
objectives.” NOTE: Total Use of Program Income
cannot exceed the total of the Balance at the start
of the reporting period plus FRP program income. Any
amount above this total indicates that there was some
other source of revenue that led to the expenditures
(Item 21).
"HTC staff" refers to the total amount spent
for salaries and benefits for HTC staff outside of the
FRP operation that came from FRP income. This includes
all medical, psychosocial, administrative, and support
staff such as physicians, nurses, social workers, physical
therapists, genetic counselors, program administrators,
interpreters, and secretarial staff (Item 22).
“Indirect costs” should include both the
indirect cost rate (%, percent) used to calculate the
indirect cost and the dollar amount of the indirect
costs. For “Indirect costs” in addition
to providing the amount of program income expended,
also provide the amount of FRP Sales Program direct
costs this is being applied to, if any (Item 23).
"Other " refers to any other types of expenditures
for which FRP income has been used. Each of these types
of expenditures is to be identified and the amount expended
for each is to be provided on a separate list and attached
to the Data Sheet. As noted above, all expenditures
in this category must be to further eligible project
or program objectives. Any cost incurred in these expenditures
must be allowable under the Federal Cost Principles
applicable to your institution (Item 24).
"Balance at end of reporting period" is calculated
by adding program income generated during the reporting
period to the Balance at the start of the reporting
period and then subtracting program income expended
during the reporting period. The Balance at the end
of the reporting period cannot be less than zero (Item
25).
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