New Funding Formula, 29270-29271 [2016-11108]
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29270
Federal Register / Vol. 81, No. 91 / Wednesday, May 11, 2016 / Notices
along with a claim for reimbursement.
Form Number: CMS–484 (OMB control
number: 0938–0534); Frequency:
Occasionally; Affected Public: Private
Sector (Business or other for-profits,
Not-for-profits); Number of
Respondents: 8,880; Total Annual
Responses: 1,632,000; Total Annual
Hours: 326,500; (For policy questions
regarding this collection contact Paula
Smith at 410–786–4709.)
2. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Durable Medical
Equipment Medicare Administrative
Contractors (MAC) Regional Carrier,
Certificate of Medical Necessity and
Supporting Documentation; Use: The
certificates of medical necessity (CMNs)
collect information required to help
determine the medical necessity of
certain items. CMS requires CMNs
where there may be a vulnerability to
the Medicare program. Each initial
claim for these items must have an
associated CMN for the beneficiary.
Suppliers (those who bill for the items)
complete the administrative information
(e.g., patient’s name and address, items
ordered, etc.) on each CMN. The 1994
Amendments to the Social Security Act
require that the supplier also provide a
narrative description of the items
ordered and all related accessories, their
charge for each of these items, and the
Medicare fee schedule allowance (where
applicable). The supplier then sends the
CMN to the treating physician or other
clinicians (e.g., physician assistant,
LPN, etc.) who completes questions
pertaining to the beneficiary’s medical
condition and signs the CMN. The
physician or other clinician returns the
CMN to the supplier who has the option
to maintain a copy and then submits the
CMN (paper or electronic) to CMS,
along with a claim for reimbursement.
Form Number: CMS–846–849, 854,
10125 and 10126 (OMB control number:
0938–0679); Frequency: Occasionally;
Affected Public: Private Sector (Business
or other for-profits, Not-for-profits);
Number of Respondents: 462,000; Total
Annual Responses: 462,000; Total
Annual Hours: 418,563; (For policy
questions regarding this collection
contact Paula Smith at 410–786–4709.)
3. Type of Information Collection
Request: Extension of a previously
approved collection; Title: Data
Collection for Medicare Beneficiaries
Receiving NaF–18 Positron Emission
Tomography (PET) to Identify Bone
Metastasis in Cancer; Use: In Decision
Memorandum #CAG–00065R, issued on
February 26, 2010, the Centers for
Medicare and Medicaid Services (CMS)
determined that the evidence is
VerDate Sep<11>2014
17:20 May 10, 2016
Jkt 238001
sufficient to conclude that for Medicare
beneficiaries receiving NaF–18 PET scan
to identify bone metastasis in cancer is
reasonable and necessary only when the
provider is participating in and patients
are enrolled in a clinical study designed
to information at the time of the scan to
assist in initial antitumor treatment
planning or to guide subsequent
treatment strategy by the identification,
location and quantification of bone
metastases in beneficiaries in whom
bone metastases are strongly suspected
based on clinical symptoms or the
results of other diagnostic studies.
Qualifying clinical studies must ensure
that specific hypotheses are addressed;
appropriate data elements are collected;
hospitals and providers are qualified to
provide the PET scan and interpret the
results; participating hospitals and
providers accurately report data on all
Medicare enrolled patients; and all
patient confidentiality, privacy, and
other Federal laws must be followed.
Consistent with section 1142 of the
Social Security Act (the Act), the
Agency for Healthcare Research and
Quality (AHRQ) supports clinical
research studies that CMS determines
meets specified standards and address
the specified research questions. To
qualify for payment, providers must
prescribe certain NaF–18 PET scans for
beneficiaries with a set of clinical
criteria specific to each solid tumor. The
statuary authority for this policy is
section 1862 (a)(1)(E) of the Act. The
need to prospectively collect
information at the time of the scan is to
assist the provider in decision making
for patient management. Form Number:
CMS–10152 (OCN: 0938–0968);
Frequency: Annually; Affected Public:
Private Sector (Business or other forprofits); Number of Respondents:
25,000; Total Annual Responses:
25,000; Total Annual Hours: 2,084
hours. (For policy questions regarding
this collection contact Stuart Caplan at
410–786–8564.)
Dated: May 6, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2016–11080 Filed 5–10–16; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
New Funding Formula
Administration on
Intellectual and Developmental
AGENCIES:
PO 00000
Frm 00022
Fmt 4703
Sfmt 4703
Disabilities (AIDD), Administration on
Disabilities (AoD), Administration for
Community Living (ACL), Department
of Health and Human Services (HHS).
ACTION: Notice.
The Administration on
Intellectual and Developmental
Disabilities (AIDD) within the
Administration on Disabilities (AoD),
located within the Administration for
Community Living (ACL) at the United
States Department of Health and Human
Services (HHS), has developed a new
funding formula for the State Councils
on Developmental Disabilities (SCDD)
and Protection and Advocacy Systems
(P&A) located in each State and
Territory.
SUMMARY:
Effective Date October 1, 2016.
The new formula is printed
below and the estimated allotments for
FY 2017 for each SCDD and P&A can be
found at: https://www.acl.gov/About_
ACL/Allocations/DD-Act.aspx.
FOR FURTHER INFORMATION CONTACT:
Andrew Morris, Office of the
Commissioner, Administration on
Disabilities, 330 C St. SW., Washington,
DC 20201. Telephone (202) 795–7408.
Email andrew.morris@acl.hhs.gov.
Please note the telephone number is not
toll free. This document will be made
available in alternative formats upon
request. Written correspondence can be
sent to Administration for Community
Living, U.S. Department of Health and
Human Services, 330 C St. SW.,
Washington, DC 20201.
SUPPLEMENTARY INFORMATION:
DATES:
ADDRESSES:
Background
The Developmental Disabilities
Assistance and Bill of Rights Act of
2000 (Pub. L. 106–402) provides, among
other things, formula grants to States for
the purpose of operating State Councils
on Developmental Disabilities and
Protection & Advocacy Systems for
people with developmental disabilities.
The Developmental Disabilities
Assistance and Bill of Rights Act of
2000 (DD Act) provides authority and
flexibility in Section 122 to determine
the formula for distributing the annual
grant awards as long as the three
statutory factors are met. These factors
are:
1. Total population of the State/
Territory
2. Need for services for people with
developmental disabilities in the State/
Territory
3. Financial need of the State/
Territory
Responding to years of requests for a
modernized funding formula and after a
E:\FR\FM\11MYN1.SGM
11MYN1
Federal Register / Vol. 81, No. 91 / Wednesday, May 11, 2016 / Notices
comprehensive development process,
AIDD published a notice in the Federal
Register on February 18, 2016 seeking
comments on a new funding formula (81
FR 8204). AIDD has reviewed the
comments submitted and is moving
forward with the proposed formula.
AIDD believes that this formula is clear,
concise, transparent, and consistent
with Congress’ intent to provide funds
to States based on greatest need. For the
P&A program, in response to the
comments received, AIDD will adopt
this new formula over a three year
period.
For complete details on methodology
and development of the new formula
please see the Federal Register,
February 18, 2016, Vol 81, Number 32,
Pages 8204–8205.
New Formula
Beginning in FY 2017, AIDD will use
a new formula to distribute funds to
SCDD and P&A programs after meeting
statutory minimums and hold-harmless
requirements for the SCDD. Funding
will be allocated to States and
Territories based on the following
criteria:
1. State/Territory Population (30%):
Based on July Census figures released in
August of each year.
2. Need for services (30%): Based on
a 1.58 percent prevalence rate for
developmental disabilities in each State
and Territory from the HHS National
Health Interview Survey on Disability
(NHIS–D).
3. Financial need (40%): Based on a
combination of poverty (20%) and
seasonally adjusted unemployment rates
(20%) from July of each calendar year.
New Formula Phase-In
mstockstill on DSK3G9T082PROD with NOTICES
In their comments to AIDD, numerous
P&A programs requested to phase in the
new formula as a way of offsetting
losses some grantees would experience
if AIDD were to begin using the new
formula immediately in FY 2017. AIDD
concurs with this requested approach,
and the new formula will be phased in
for the P&A programs only with funds
allotted in the following manner:
FY 2017: 75 percent previous formula
and 25 percent new formula
FY 2018: 50 percent previous formula
and 50 percent new formula
FY 2019: 100 percent new formula
The new formula will be in full effect
for the SCDD programs on October 1,
2016. SCDDs will likely not experience
significant fluctuations in their annual
allotment due to that program’s holdharmless requirement.
VerDate Sep<11>2014
17:20 May 10, 2016
Jkt 238001
Response to Public Comments
General
AIDD received 75 comments related
to the new formula including 39
comments from SCDDs and 18 from
P&As. AIDD also received 18 comments
from other entities including non-profits
and State agencies. Comments were
received on each of the three required
formula factors and weighting of the
factors. Comments on the new formula
were generally favorable and
supportive. Commenters acknowledged
that the current formula is more than 35
years old and uses data sources that do
not adequately take into account the
needs of people with developmental
disabilities. Generally, they found the
new formula to be more transparent and
easier to understand. Comments also
reinforced the need for the new formula
in order to ease the administrative
burden on ACL. Commenters pointed
out that the previous formula used the
per capita income rate which was an
inadequate way to measure financial
need and AIDD concurs with this
comment. Several commenters stated
that the current minimum allotments
are inadequate; however these
minimum allotments are set in statute
and therefore not subject to change by
AIDD.
Population
Some commenters requested that
population have a higher weight in the
formula. AIDD declined to raise the
weighting as doing so could cause larger
swings in the formula year-to-year and
thereby make it more difficult for States
to plan for their operating needs. Some
commenters asked for the population of
people with developmental disabilities
to be considered rather than the total
population. However, the DD Act
requires that the entire State population
must be taken into consideration.
Need for Services
As the formula workgroup and AIDD
determined, the most clear and concise
way to determine the need for services
was to use the most current federal data
for prevalence of people with
developmental disabilities. Some
commenters asked that AIDD use the
Centers for Disease Control (CDC)
prevalence rates for people with
developmental disabilities, however,
CDC’s definition of developmental
disabilities does not match AIDD’s
statutory definition.
Several commenters asked for
different data to be used to determine
the need for services in each State and
Territory. There were varied opinions
and suggestions, but none were clearly
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
29271
stronger than the sources proposed by
AIDD.
Commenters also asked for the use of
prevalence rates by State. That data is
not currently available. AIDD is working
with its federal partners to identify
future opportunities to better
understand the prevalence of
developmental disabilities.
Financial Need
AIDD and the formula workgroup
weighted financial need at 40 percent,
with 20 percent based on State/Territory
poverty levels and 20 percent based on
seasonally adjusted unemployment data
from July of each year. The workgroup
felt that these measures were the best
economic indicators to measure a State’s
financial need.
Several commenters asked for
additional measures such as cost of
living adjustments, workforce
participation rates, and supplemental
measures of poverty. HHS data experts
stated that these data were not as
reliable as the ones proposed and that
the use of any of these data, including
workforce participation rates, would not
make a significant difference in the
distribution of funds. Further, use of
several of the proposed data would
make the formula more complicated.
Other commenters stated the need to
use different data sources but did not
give alternatives as was requested in the
request for public comments. Therefore,
AIDD concluded that there was no
compelling reason to change data used
for financial need.
Dated: May 5, 2016.
Jennifer Johnson,
Deputy Director, Administration on
Intellectual and Developmental Disabilities.
[FR Doc. 2016–11108 Filed 5–10–16; 8:45 am]
BILLING CODE 4154–04–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0730]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Threshold of
Regulation for Substances Used in
Food-Contact Articles
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
SUMMARY:
E:\FR\FM\11MYN1.SGM
11MYN1
Agencies
[Federal Register Volume 81, Number 91 (Wednesday, May 11, 2016)]
[Notices]
[Pages 29270-29271]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11108]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Community Living
New Funding Formula
AGENCIES: Administration on Intellectual and Developmental Disabilities
(AIDD), Administration on Disabilities (AoD), Administration for
Community Living (ACL), Department of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Administration on Intellectual and Developmental
Disabilities (AIDD) within the Administration on Disabilities (AoD),
located within the Administration for Community Living (ACL) at the
United States Department of Health and Human Services (HHS), has
developed a new funding formula for the State Councils on Developmental
Disabilities (SCDD) and Protection and Advocacy Systems (P&A) located
in each State and Territory.
DATES: Effective Date October 1, 2016.
ADDRESSES: The new formula is printed below and the estimated
allotments for FY 2017 for each SCDD and P&A can be found at: https://www.acl.gov/About_ACL/Allocations/DD-Act.aspx.
FOR FURTHER INFORMATION CONTACT: Andrew Morris, Office of the
Commissioner, Administration on Disabilities, 330 C St. SW.,
Washington, DC 20201. Telephone (202) 795-7408. Email
andrew.morris@acl.hhs.gov. Please note the telephone number is not toll
free. This document will be made available in alternative formats upon
request. Written correspondence can be sent to Administration for
Community Living, U.S. Department of Health and Human Services, 330 C
St. SW., Washington, DC 20201.
SUPPLEMENTARY INFORMATION:
Background
The Developmental Disabilities Assistance and Bill of Rights Act of
2000 (Pub. L. 106-402) provides, among other things, formula grants to
States for the purpose of operating State Councils on Developmental
Disabilities and Protection & Advocacy Systems for people with
developmental disabilities. The Developmental Disabilities Assistance
and Bill of Rights Act of 2000 (DD Act) provides authority and
flexibility in Section 122 to determine the formula for distributing
the annual grant awards as long as the three statutory factors are met.
These factors are:
1. Total population of the State/Territory
2. Need for services for people with developmental disabilities in
the State/Territory
3. Financial need of the State/Territory
Responding to years of requests for a modernized funding formula and
after a
[[Page 29271]]
comprehensive development process, AIDD published a notice in the
Federal Register on February 18, 2016 seeking comments on a new funding
formula (81 FR 8204). AIDD has reviewed the comments submitted and is
moving forward with the proposed formula. AIDD believes that this
formula is clear, concise, transparent, and consistent with Congress'
intent to provide funds to States based on greatest need. For the P&A
program, in response to the comments received, AIDD will adopt this new
formula over a three year period.
For complete details on methodology and development of the new
formula please see the Federal Register, February 18, 2016, Vol 81,
Number 32, Pages 8204-8205.
New Formula
Beginning in FY 2017, AIDD will use a new formula to distribute
funds to SCDD and P&A programs after meeting statutory minimums and
hold-harmless requirements for the SCDD. Funding will be allocated to
States and Territories based on the following criteria:
1. State/Territory Population (30%): Based on July Census figures
released in August of each year.
2. Need for services (30%): Based on a 1.58 percent prevalence rate
for developmental disabilities in each State and Territory from the HHS
National Health Interview Survey on Disability (NHIS-D).
3. Financial need (40%): Based on a combination of poverty (20%)
and seasonally adjusted unemployment rates (20%) from July of each
calendar year.
New Formula Phase-In
In their comments to AIDD, numerous P&A programs requested to phase
in the new formula as a way of offsetting losses some grantees would
experience if AIDD were to begin using the new formula immediately in
FY 2017. AIDD concurs with this requested approach, and the new formula
will be phased in for the P&A programs only with funds allotted in the
following manner:
FY 2017: 75 percent previous formula and 25 percent new formula
FY 2018: 50 percent previous formula and 50 percent new formula
FY 2019: 100 percent new formula
The new formula will be in full effect for the SCDD programs on October
1, 2016. SCDDs will likely not experience significant fluctuations in
their annual allotment due to that program's hold-harmless requirement.
Response to Public Comments
General
AIDD received 75 comments related to the new formula including 39
comments from SCDDs and 18 from P&As. AIDD also received 18 comments
from other entities including non-profits and State agencies. Comments
were received on each of the three required formula factors and
weighting of the factors. Comments on the new formula were generally
favorable and supportive. Commenters acknowledged that the current
formula is more than 35 years old and uses data sources that do not
adequately take into account the needs of people with developmental
disabilities. Generally, they found the new formula to be more
transparent and easier to understand. Comments also reinforced the need
for the new formula in order to ease the administrative burden on ACL.
Commenters pointed out that the previous formula used the per capita
income rate which was an inadequate way to measure financial need and
AIDD concurs with this comment. Several commenters stated that the
current minimum allotments are inadequate; however these minimum
allotments are set in statute and therefore not subject to change by
AIDD.
Population
Some commenters requested that population have a higher weight in
the formula. AIDD declined to raise the weighting as doing so could
cause larger swings in the formula year-to-year and thereby make it
more difficult for States to plan for their operating needs. Some
commenters asked for the population of people with developmental
disabilities to be considered rather than the total population.
However, the DD Act requires that the entire State population must be
taken into consideration.
Need for Services
As the formula workgroup and AIDD determined, the most clear and
concise way to determine the need for services was to use the most
current federal data for prevalence of people with developmental
disabilities. Some commenters asked that AIDD use the Centers for
Disease Control (CDC) prevalence rates for people with developmental
disabilities, however, CDC's definition of developmental disabilities
does not match AIDD's statutory definition.
Several commenters asked for different data to be used to determine
the need for services in each State and Territory. There were varied
opinions and suggestions, but none were clearly stronger than the
sources proposed by AIDD.
Commenters also asked for the use of prevalence rates by State.
That data is not currently available. AIDD is working with its federal
partners to identify future opportunities to better understand the
prevalence of developmental disabilities.
Financial Need
AIDD and the formula workgroup weighted financial need at 40
percent, with 20 percent based on State/Territory poverty levels and 20
percent based on seasonally adjusted unemployment data from July of
each year. The workgroup felt that these measures were the best
economic indicators to measure a State's financial need.
Several commenters asked for additional measures such as cost of
living adjustments, workforce participation rates, and supplemental
measures of poverty. HHS data experts stated that these data were not
as reliable as the ones proposed and that the use of any of these data,
including workforce participation rates, would not make a significant
difference in the distribution of funds. Further, use of several of the
proposed data would make the formula more complicated. Other commenters
stated the need to use different data sources but did not give
alternatives as was requested in the request for public comments.
Therefore, AIDD concluded that there was no compelling reason to change
data used for financial need.
Dated: May 5, 2016.
Jennifer Johnson,
Deputy Director, Administration on Intellectual and Developmental
Disabilities.
[FR Doc. 2016-11108 Filed 5-10-16; 8:45 am]
BILLING CODE 4154-04-P