Attachment 2 - 60 day FRN

16792

Federal Register / Vol. 72, No. 65 / Thursday, April 5, 2007 / Notices

Dated: March 30, 2007.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E7–6340 Filed 4–4–07; 8:45 am]
BILLING CODE 4163–18–P

this research will give scientists and
health professionals greater insight into
the airborne transmission of disease and
allow them to better assess the potential
effectiveness of preventive measures.
The first part of this study will
measure the quantity and size
distribution of aerosol produced during
human coughs. To accomplish this,
volunteers will cough into a spirometer,
which is a commonly used piston-like
medical device that measures the
volume of air exhaled by a patient. After
the volunteer coughs into the
spirometer, the air in the spirometer
will be drawn into a commercial aerosol
measurement device. These experiments
will also provide information on how
much cough aerosols vary over time for
individuals and how much aerosol
generation varies between individuals.
The second part of this study will
determine how effectively surgical
masks and N95 respirators block coughgenerated aerosols. N95 respirators are
dust masks that are certified to filter out
at least 95% of airborne material during
normal breathing. N95 respirators are
known to be more effective than surgical
masks at filtering out airborne particles
during inhalation, but it is not known
whether masks or respirators are more
effective at blocking cough-generated
aerosols. For this work, masks and
respirators will be placed in a special
holder with a disposable mouthpiece,
and human subjects will cough into the
mouthpiece and through the mask. The
aerosol produced by each subject will be
analyzed before and after flowing
through the mask. These experiments
will determine how effective each mask
or respirator is at preventing the release
of cough-generated aerosols.
Volunteers from part 1 may also
participate in part 2 if they wish. There
will be no costs to study participants
other than their time.

on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.
Proposed Project

Centers for Disease Control and
Prevention

Aerosol Generation by Cough—
NEW—The National Institute for
Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention (CDC).

[60 Day–07–06AP]

Background and Brief Description

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–4766 and
send comments to Seleda Perryman,
CDC Assistant Reports Clearance
Officer, 1600 Clifton Road, MS–D74,
Atlanta, GA 30333 or send an e-mail to
omb@cdc.gov.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information

The Federal Occupational Safety and
Health Act of 1970, section 501, enables
NIOSH to carry out research relevant to
the health and safety of workers. NIOSH
is conducting a two-year study of
airborne clouds of particles or droplets
called ‘‘aerosols’’. Some diseases like
influenza and Severe Acute Respiratory
Syndrome (SARS) can be spread when
people produce infectious aerosols by
coughing or sneezing. Aerosol
transmission of infectious diseases is
especially important to health-care
workers and emergency responders,
who face a much greater risk of
exposure to these hazards than does the
general public. Cough-generated
aerosols are of particular concern
because coughing is one of the most
common symptoms of respiratory
infections. However, substantial gaps
exist in our understanding about the
generation of aerosols during coughing.
This lack of information hampers the
ability of health scientists to model and
predict the generation of infectious
aerosols by coughing and to understand
whether or not cough-generated aerosols
are likely to be an important means of
transmission of particular diseases.
The purpose of this study is to gain
a better understanding of the production
of aerosols by coughing. The results of

ESTIMATE OF ANNUALIZED BURDEN HOURS
Number of
respondents

jlentini on PROD1PC65 with NOTICES

Respondents

Number of
responses per
respondent

Average
burden
per response
(in hours)

Total burden
(in hours)

Part 1 participants ............................................................................................
Part 2 participants ............................................................................................

20
120

5
1

1.5
1.5

150
180

Total ..........................................................................................................

........................

........................

........................

330

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Federal Register / Vol. 72, No. 65 / Thursday, April 5, 2007 / Notices
Dated: March 29, 2007.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E7–6344 Filed 4–4–07; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
Notice of Hearing: Reconsideration of
Disapproval of Minnesota State Plan
Amendment 05–10
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice of hearing.

jlentini on PROD1PC65 with NOTICES

AGENCY:

SUMMARY: This notice announces an
administrative hearing to be held on
May 30, 2007, at 233 N. Michigan
Avenue, Suite 600, the Indiana Room,
Chicago, IL 60601, to reconsider CMS’
decision to disapprove Minnesota State
plan amendment 05–10.
CLOSING DATE: Requests to participate in
the hearing as a party must be received
by the presiding officer by (15 days after
publication).
FOR FURTHER INFORMATION CONTACT:
Kathleen Scully-Hayes, Presiding
Officer, CMS, Lord Baltimore Drive,
Mail Stop LB–23–20, Baltimore,
Maryland 21244. Telephone: (410) 786–
2055.
SUPPLEMENTARY INFORMATION: This
notice announces an administrative
hearing to reconsider CMS’ decision to
disapprove Minnesota State plan
amendment (SPA) 05–10 which was
submitted on September 21, 2005. This
SPA was disapproved on December 29,
2006.
Under this SPA, the State proposed to
revise coverage and reimbursement
methodology for Early and Periodic
Screening, Diagnosis, and Treatment
services related to children’s mental
health rehabilitative services and
rehabilitative services pursuant to an
Individualized Education Plan or
Individual Family Service Plan.
The amendment was disapproved
because CMS found that the amendment
violated the statute for reasons set forth
in the disapproval letter.
The issues to be decided at the
hearing are:
• Whether the per diem (bundled)
payment methodologies for mental
health rehabilitative services described
in Minnesota’s SPA 05–10 accurately
reflect true costs or reasonable fees for
the services included in the bundles;

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• Whether the amount or scope of
services reimbursed through the
bundled rate is sufficiently constant so
that the proposed methodologies would
be an economic and efficient method of
payment;
• Whether all of the component parts
of the service are delivered as
recommended within the scope of
practice of the physician or licensed
practitioner of the healing arts;
• Whether the actual practitioners
who will be furnishing services can be
readily identified; and
• Whether the bundled rates provide
for direct payment to the actual
practitioners who provide the service.
Section 1116 of the Social Security
Act and Federal regulations at 42 CFR
part 430, establish Department
procedures that provide an
administrative hearing for
reconsideration of a disapproval of a
State plan or plan amendment. CMS is
required to publish a copy of the notice
to a State Medicaid agency that informs
the agency of the time and place of the
hearing, and the issues to be considered.
If we subsequently notify the agency of
additional issues that will be considered
at the hearing, we will also publish that
notice.
Any individual or group that wants to
participate in the hearing as a party
must petition the presiding officer
within 15 days after publication of this
notice, in accordance with the
requirements contained at 42 CFR
430.76(b)(2). Any interested person or
organization that wants to participate as
amicus curiae must petition the
presiding officer before the hearing
begins in accordance with the
requirements contained at 42 CFR
430.76(c). If the hearing is later
rescheduled, the presiding officer will
notify all participants.
The Notice to Minnesota Announcing
an Administrative Hearing To
Reconsider the Disapproval of Its SPA
Reads as Follows
Ms. Christine Bronson,
Medicaid Director,
Minnesota Department of Human Services,
P.O. Box 64998,
St. Paul, MN 55164–0998
Dear Ms. Bronson: I am responding to your
request for reconsideration of the decision to
disapprove the Minnesota State plan
amendment (SPA) 05–10, which was
submitted on September 21, 2005, and
disapproved on December 29, 2006.
Under this SPA, the State proposed to
revise coverage and reimbursement
methodology for Early and Periodic
Screening, Diagnosis, and Treatment services
related to children’s mental health
rehabilitative services and rehabilitative
services pursuant to an Individualized

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16793

Education Plan or Individual Family Service
Plan. The Centers for Medicare & Medicaid
Services (CMS) disapproved the SPA because
the State did not document that its proposed
reimbursement methodology meets the
conditions specified in sections 1902(a)(10),
1902(a)(30), and 1902(a)(32) of the Social
Security Act (the Act).
At issue in this reconsideration is whether
Minnesota has demonstrated that the
bundled rate methodology proposed in SPA
05–10 is consistent with the requirements of
section 1902(a)(30)(A) of the Act, which
requires that States have methods and
procedures to assure that payments to
providers are consistent with efficiency,
economy, and quality of care. A second issue
is whether the State has shown that the
payment methodology is for care and services
that are within the scope, and meet the
requirements, of section 1902(a)(10)(A) to
make available ‘‘medical assistance,’’ which
is defined at section 1905(a) and
implementing requirements. Also at issue is
whether the proposed payment methodology
complies with the direct payment
requirements of section 1902(a)(32) of the
Act, which precludes payment to anyone
other than the individual, person, or
institution providing the care and service
(with specified exceptions). We discuss each
of these issues in more detail below in
relation to SPA 05–10.
Section 1902(a)(30)(A) of the Act requires
that States have methods and procedures to
assure that payments to providers are
consistent with efficiency, economy, and
quality of care. The per diem payment
methodologies for mental health
rehabilitative services described in SPA 05–
10 represent bundled payment
methodologies under which the State pays a
single rate for one or more of a group of
different services furnished to an eligible
individual during a fixed period of time. The
State has failed to demonstrate that its
methodologies are in compliance with
section 1902(a)(30)(A), in that it has not
shown: that these methodologies accurately
reflect true costs or reasonable fees for the
services included in the bundles; and that the
amount or scope of services reimbursed
through the bundled rate is sufficiently
constant so that the proposed methodologies
would be an economic and efficient method
of payment.
Section 1902(a)(10)(A) requires that State
plans make available medical assistance,
which is defined at section 1905(a) and in
implementing regulations. For a number of
categories of medical assistance, there are
provider standards applicable to different
types of care and services, and for
rehabilitative services there is a requirement
that rehabilitative services must be
recommended by a physician or other
licensed practitioner of the healing arts.
Minnesota did not provide evidence of a
method to identify that providers of the
component parts of the care and services
would meet all applicable provider
requirements. Nor did Minnesota
demonstrate a method to ensure that all of
the component parts of the care and services
furnished under the bundled payment
methodology proposed in SPA 05–10, would

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