Agency Information Collection Activities: Proposed Collection; Comment Request, 47852-47853 [2012-19694]
Download as PDF
47852
Federal Register / Vol. 77, No. 155 / Friday, August 10, 2012 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier CMS–10381, CMS–484,
CMS–10152 and CMS–R–290]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
Services (CMS) is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title: ICD–10
Industry Readiness Assessment; Use:
The Congress addressed the need for a
consistent framework for electronic
transactions and other administrative
simplification issues in the Health
Insurance Portability and
Accountability Act of 1996 (HIPAA),
Public Law 104–191, enacted on August
21, 1996. Through subtitle F of title II
of HIPAA, the Congress added to title XI
of the Social Security Act (the Act) a
new Part C, entitled ‘‘Administrative
Simplification.’’ Part C of title XI of the
Act now consists of sections 1171
through 1180, which define various
terms and impose several requirements
on HHS, health plans, health care
clearinghouses, and certain health care
providers concerning the transmission
of health information. Specifically,
HIPAA requires the Secretary of HHS to
adopt standards that covered entities are
required to use in conducting certain
health care administrative transactions,
such as claims, remittance, eligibility,
and claims status requests and
responses. Findings from the ICD–10
industry readiness assessment will be
used by CMS to understand each
mstockstill on DSK4VPTVN1PROD with NOTICES
AGENCY:
VerDate Mar<15>2010
18:02 Aug 09, 2012
Jkt 226001
sector’s progress toward compliance and
to determine what communication and
educational efforts can best help
affected entities obtain the tools and
resources they need to achieve timely
compliance with ICD–10. Insights
gleaned from the proposed research will
be valid for education and outreach
purposes only, and will not be used for
policy purposes. Form Number: CMS–
10381 (OCN: 0938–1149); Frequency:
Annual; Affected Public: Private
Sector—Business or other for-profits,
Not-for-profits; Number of Respondents:
1,200; Total Annual Responses: 1,200;
Total Annual Hours: 204. (For policy
questions regarding this collection
contact Rosali Topper at 410–786–7260.
For all other issues call 410–786–1326.)
2. Type of Information Collection
Request: Reinstatement of a previously
approved collection; Title: Attending
Physician’s Certification of Medical
Necessity for Home Oxygen Therapy
and Supporting Documentation
Requirements; Use: Under Section
1862(a)(1)(A) of the Social Security Act
(the Act), 42 U.S.C. 1395y(a), the
Secretary may only pay for items and
services that are ‘‘reasonable and
necessary for the diagnosis or treatment
of illness or injury or to improve the
functioning of a malformed body
member.’’ In order to assure this, CMS
and its contractors develop Medical
policies that specify the circumstances
under which an item or service can be
covered. The certificate of medical
necessity (CMN) provides a mechanism
for suppliers of Durable Medical
Equipment, defined in 42 U.S.C. 1395x
(n), and Medical Equipment and
Supplies defined in 42 U.S.C. 1395j(5),
to demonstrate that the item being
provided meets the criteria for Medicare
coverage. Section 1833(e), 42 U.S.C.
1395l(e), provides that no payment can
be made to any provider of services, or
other person, unless that person has
furnished the information necessary for
Medicare or its contractor to determine
the amounts due to be paid. Certain
individuals can use a CMN to furnish
this information, rather than having to
produce large quantities of medical
records for every claim they submit for
payment. Under Section 1834(j)(2) of
the Act, 42 U.S.C. 1395m(j)(2), suppliers
of DME items are prohibited from
providing medical information to
physicians when a CMN is being
completed to document medical
necessity. The physician who orders the
item is responsible for providing the
information necessary to demonstrate
that the item provided is reasonable and
necessary and the supplier shall also list
on the CMN the fee schedule amount
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
and the suppliers charge for the medical
equipment or supplies being furnished
prior to distribution of such certificate
to the physician. Any supplier of
medical equipment who knowingly and
willfully distributes a CMN in violation
of this restriction is subject to penalties,
including civil money penalties (42
U.S.C. 1395m(j)(2)(A)(iii)). Under
Section 42 Code of Federal Regulations
§ 410.38 and § 424.5, Medicare has the
legal authority to collect sufficient
information to determine payment for
oxygen, and oxygen equipment. Oxygen
and oxygen equipment is by far the
largest single total charge of all items
paid under durable medical equipment
coverage authority. Detailed criteria
concerning coverage of home oxygen
therapy are found in Medicare Carriers
Manual Chapter II–Coverage Issues
Appendix, Section 60–4. For Medicare
to consider any item for coverage and
payment, the information submitted by
the supplier (e.g., claims and CMNs),
including documentation in the
patient’s medical records must
corroborate that the patient meets
Medicare coverage criteria. The patient’s
medical records may include:
physician’s office records; hospital
records; nursing home records; home
health agency records; records from
other healthcare professionals or test
reports. This documentation must be
available to the DME MACs upon
request. Form Number: CMS–484 (OCN:
0938–0534); Frequency: Occasionally;
Affected Public: Private Sector: Business
or other for-profits, Not-for-profits;
Number of Respondents: 8,880; Total
Annual Responses: 1,541,359; Total
Annual Hours: 308,271. (For policy
questions regarding this collection
contact Doris Jackson at 410–786–4459.
For all other issues call 410–786–1326.)
3. Type of Information Collection
Request: Reinstatement 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
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
E:\FR\FM\10AUN1.SGM
10AUN1
mstockstill on DSK4VPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 155 / Friday, August 10, 2012 / Notices
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 Agency for
Healthcare Research and Quality
(AHRQ) supports clinical research
studies that the CMS determines meet
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 Social
Security 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: Annual; Affected
Public: Private Sector—Business or
other for-profits; Number of
Respondents: 25,000; Total Annual
Responses: 25,000; Total Annual Hours:
2,084. (For policy questions regarding
this collection contact Stuart Caplan at
410–786–8564. For all other issues call
410–786–1326.)
4. Type of Information Collection
Request: Reinstatement of a currently
approved collection; Title: Medicare
Program: Procedures for Making
National Coverage Decisions; Use: The
Centers for Medicare & Medicaid
Services (CMS) revised the April 27,
1999 (64 FR 22619) notice and
published a new notice on September
26, 2003 (68 FR 55634) that described
the process we use to make Medicare
coverage decisions including decisions
regarding whether new technology and
services can be covered. We have made
changes to our internal procedures in
response to the comments we received
following publication of the 1999 notice
and experience under our new process.
Over the past several years, we received
numerous suggestions to further revise
our process to continue to make it more
open, responsive, and understandable to
the public. We share the goal of
increasing public participation in the
development of Medicare coverage
issues. This will assist us in obtaining
the information we require to make a
VerDate Mar<15>2010
18:02 Aug 09, 2012
Jkt 226001
national coverage determination in a
timely manner and ensuring that the
Medicare program continues to meet the
needs of its beneficiaries. Form Number:
CMS–R–290 (OCN: 0938–0776);
Frequency: Annual; Affected Public:
Private Sector: Business or other forprofits; Number of Respondents: 200;
Total Annual Responses: 200; Total
Annual Hours: 8,000. (For policy
questions regarding this collection
contact Katherine Tillman at 410–786–
9252. For all other issues call 410–786–
1326.)
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web Site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or
Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
In commenting on the proposed
information collections please reference
the document identifier or OMB control
number. To be assured consideration,
comments and recommendations must
be submitted in one of the following
ways by October 9, 2012:
1. Electronically. You may submit
your comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) accepting comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number lll, Room C4–26–
05, 7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
Dated: August 7, 2012.
Martique Jones,
Director, Regulations Development Group,
Division B Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2012–19694 Filed 8–9–12; 8:45 am]
BILLING CODE 4120–01–P
PO 00000
47853
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0781]
Request for Notification From Industry
Organizations Interested in
Participating in Selection Process for
Nonvoting Industry Representative on
the Pediatric Advisory Committee and
Request for Nominations for
Nonvoting Industry Representatives on
the Pediatric Advisory Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting that
any industry organizations interested in
participating in the selection of a
nonvoting industry representative to
serve on the Pediatric Advisory
Committee for the Office of the
Commissioner (OC) notify FDA in
writing. FDA is also requesting
nominations for a nonvoting industry
representative(s) to serve on the
Pediatric Advisory Committee. A
nominee may either be self-nominated
or nominated by an organization to
serve as a nonvoting industry
representative. Nominations will be
accepted for current vacancies effective
with this notice.
DATES: Any industry organization
interested in participating in the
selection of an appropriate nonvoting
member to represent industry interests
must send a letter stating that interest to
FDA by September 10, 2012, for the
vacancy listed in this notice.
Concurrently, nomination materials for
prospective candidates should be sent to
FDA by September 10, 2012.
ADDRESSES: All letters of interest and
nominations should be submitted in
writing to Walter Ellenberg (see FOR
FURTHER INFORMATION CONTACT).
FOR FURTHER INFORMATION CONTACT:
Walter Ellenberg, Office of the
Commissioner, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5154, Silver Spring,
MD 20993, 301–796–0885, FAX: 301–
847–8640, walter.ellenberg@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Agency intends to add a nonvoting
industry representative(s) to the
following advisory committee:
SUMMARY:
I. OC Advisory Committee
Pediatric Advisory Committee
The Committee reviews and evaluates
and makes recommendations to the
Commissioner of Food and Drugs
Frm 00054
Fmt 4703
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10AUN1
Agencies
[Federal Register Volume 77, Number 155 (Friday, August 10, 2012)]
[Notices]
[Pages 47852-47853]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-19694]
[[Page 47852]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier CMS-10381, CMS-484, CMS-10152 and CMS-R-290]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & Medicaid Services, HHS.
In compliance with the requirement of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid
Services (CMS) is publishing the following summary of proposed
collections for public comment. Interested persons are invited to send
comments regarding this burden estimate or any other aspect of this
collection of information, including any of the following subjects: (1)
The necessity and utility of the proposed information collection for
the proper performance of the agency's functions; (2) the accuracy of
the estimated burden; (3) ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) the use of
automated collection techniques or other forms of information
technology to minimize the information collection burden.
1. Type of Information Collection Request: Revision of a currently
approved collection; Title: ICD-10 Industry Readiness Assessment; Use:
The Congress addressed the need for a consistent framework for
electronic transactions and other administrative simplification issues
in the Health Insurance Portability and Accountability Act of 1996
(HIPAA), Public Law 104-191, enacted on August 21, 1996. Through
subtitle F of title II of HIPAA, the Congress added to title XI of the
Social Security Act (the Act) a new Part C, entitled ``Administrative
Simplification.'' Part C of title XI of the Act now consists of
sections 1171 through 1180, which define various terms and impose
several requirements on HHS, health plans, health care clearinghouses,
and certain health care providers concerning the transmission of health
information. Specifically, HIPAA requires the Secretary of HHS to adopt
standards that covered entities are required to use in conducting
certain health care administrative transactions, such as claims,
remittance, eligibility, and claims status requests and responses.
Findings from the ICD-10 industry readiness assessment will be used by
CMS to understand each sector's progress toward compliance and to
determine what communication and educational efforts can best help
affected entities obtain the tools and resources they need to achieve
timely compliance with ICD-10. Insights gleaned from the proposed
research will be valid for education and outreach purposes only, and
will not be used for policy purposes. Form Number: CMS-10381 (OCN:
0938-1149); Frequency: Annual; Affected Public: Private Sector--
Business or other for-profits, Not-for-profits; Number of Respondents:
1,200; Total Annual Responses: 1,200; Total Annual Hours: 204. (For
policy questions regarding this collection contact Rosali Topper at
410-786-7260. For all other issues call 410-786-1326.)
2. Type of Information Collection Request: Reinstatement of a
previously approved collection; Title: Attending Physician's
Certification of Medical Necessity for Home Oxygen Therapy and
Supporting Documentation Requirements; Use: Under Section 1862(a)(1)(A)
of the Social Security Act (the Act), 42 U.S.C. 1395y(a), the Secretary
may only pay for items and services that are ``reasonable and necessary
for the diagnosis or treatment of illness or injury or to improve the
functioning of a malformed body member.'' In order to assure this, CMS
and its contractors develop Medical policies that specify the
circumstances under which an item or service can be covered. The
certificate of medical necessity (CMN) provides a mechanism for
suppliers of Durable Medical Equipment, defined in 42 U.S.C. 1395x (n),
and Medical Equipment and Supplies defined in 42 U.S.C. 1395j(5), to
demonstrate that the item being provided meets the criteria for
Medicare coverage. Section 1833(e), 42 U.S.C. 1395l(e), provides that
no payment can be made to any provider of services, or other person,
unless that person has furnished the information necessary for Medicare
or its contractor to determine the amounts due to be paid. Certain
individuals can use a CMN to furnish this information, rather than
having to produce large quantities of medical records for every claim
they submit for payment. Under Section 1834(j)(2) of the Act, 42 U.S.C.
1395m(j)(2), suppliers of DME items are prohibited from providing
medical information to physicians when a CMN is being completed to
document medical necessity. The physician who orders the item is
responsible for providing the information necessary to demonstrate that
the item provided is reasonable and necessary and the supplier shall
also list on the CMN the fee schedule amount and the suppliers charge
for the medical equipment or supplies being furnished prior to
distribution of such certificate to the physician. Any supplier of
medical equipment who knowingly and willfully distributes a CMN in
violation of this restriction is subject to penalties, including civil
money penalties (42 U.S.C. 1395m(j)(2)(A)(iii)). Under Section 42 Code
of Federal Regulations Sec. 410.38 and Sec. 424.5, Medicare has the
legal authority to collect sufficient information to determine payment
for oxygen, and oxygen equipment. Oxygen and oxygen equipment is by far
the largest single total charge of all items paid under durable medical
equipment coverage authority. Detailed criteria concerning coverage of
home oxygen therapy are found in Medicare Carriers Manual Chapter II-
Coverage Issues Appendix, Section 60-4. For Medicare to consider any
item for coverage and payment, the information submitted by the
supplier (e.g., claims and CMNs), including documentation in the
patient's medical records must corroborate that the patient meets
Medicare coverage criteria. The patient's medical records may include:
physician's office records; hospital records; nursing home records;
home health agency records; records from other healthcare professionals
or test reports. This documentation must be available to the DME MACs
upon request. Form Number: CMS-484 (OCN: 0938-0534); Frequency:
Occasionally; Affected Public: Private Sector: Business or other for-
profits, Not-for-profits; Number of Respondents: 8,880; Total Annual
Responses: 1,541,359; Total Annual Hours: 308,271. (For policy
questions regarding this collection contact Doris Jackson at 410-786-
4459. For all other issues call 410-786-1326.)
3. Type of Information Collection Request: Reinstatement 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
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
[[Page 47853]]
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 Agency for
Healthcare Research and Quality (AHRQ) supports clinical research
studies that the CMS determines meet 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 Social Security 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: Annual; Affected
Public: Private Sector--Business or other for-profits; Number of
Respondents: 25,000; Total Annual Responses: 25,000; Total Annual
Hours: 2,084. (For policy questions regarding this collection contact
Stuart Caplan at 410-786-8564. For all other issues call 410-786-1326.)
4. Type of Information Collection Request: Reinstatement of a
currently approved collection; Title: Medicare Program: Procedures for
Making National Coverage Decisions; Use: The Centers for Medicare &
Medicaid Services (CMS) revised the April 27, 1999 (64 FR 22619) notice
and published a new notice on September 26, 2003 (68 FR 55634) that
described the process we use to make Medicare coverage decisions
including decisions regarding whether new technology and services can
be covered. We have made changes to our internal procedures in response
to the comments we received following publication of the 1999 notice
and experience under our new process. Over the past several years, we
received numerous suggestions to further revise our process to continue
to make it more open, responsive, and understandable to the public. We
share the goal of increasing public participation in the development of
Medicare coverage issues. This will assist us in obtaining the
information we require to make a national coverage determination in a
timely manner and ensuring that the Medicare program continues to meet
the needs of its beneficiaries. Form Number: CMS-R-290 (OCN: 0938-
0776); Frequency: Annual; Affected Public: Private Sector: Business or
other for-profits; Number of Respondents: 200; Total Annual Responses:
200; Total Annual Hours: 8,000. (For policy questions regarding this
collection contact Katherine Tillman at 410-786-9252. For all other
issues call 410-786-1326.)
To obtain copies of the supporting statement and any related forms
for the proposed paperwork collections referenced above, access CMS'
Web Site address at https://www.cms.hhs.gov/PaperworkReductionActof1995,
or Email your request, including your address, phone number, OMB
number, and CMS document identifier, to Paperwork@cms.hhs.gov, or call
the Reports Clearance Office on (410) 786-1326.
In commenting on the proposed information collections please
reference the document identifier or OMB control number. To be assured
consideration, comments and recommendations must be submitted in one of
the following ways by October 9, 2012:
1. Electronically. You may submit your comments electronically to
https://www.regulations.gov. Follow the instructions for ``Comment or
Submission'' or ``More Search Options'' to find the information
collection document(s) accepting comments.
2. By regular mail. You may mail written comments to the following
address: CMS, Office of Strategic Operations and Regulatory Affairs,
Division of Regulations Development, Attention: Document Identifier/OMB
Control Number ------, Room C4-26-05, 7500 Security Boulevard,
Baltimore, Maryland 21244-1850.
Dated: August 7, 2012.
Martique Jones,
Director, Regulations Development Group, Division B Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2012-19694 Filed 8-9-12; 8:45 am]
BILLING CODE 4120-01-P