Agency Information Collection Activities: Proposed Collection; Comment Request, 27400-27402 [2013-11035]
Download as PDF
<![CDATA[
mstockstill on DSK4VPTVN1PROD with NOTICES
27400
Federal Register / Vol. 78, No. 91 / Friday, May 10, 2013 / Notices
specifically required the Secretary to
establish and implement programs
under which competitive bidding areas
are established throughout the United
States for contract award purposes for
the furnishing of certain competitively
priced items and services for which
payment is made under Medicare Part
B. This program is commonly known as
the ‘‘Medicare DMEPOS Competitive
Bidding Program.’’
CMS conducted its first round of
bidding for the Medicare DMEPOS
Competitive Bidding Program in 2007
with the help of its contractor, the
Competitive Bidding Implementation
Contractor. CMS published a Request
for Bids instructions and accompanying
forms for suppliers to submit their bids
to participate in the program. During
this first round of bidding, DMEPOS
suppliers from across the U.S. submitted
bids identifying the MSA(s) to service
and the competitively bid item(s) they
wished to furnish to Medicare
beneficiaries. CMS evaluated these bids
and contracted with those suppliers that
met all program requirements. The first
round of bidding was successfully
implemented on July 1, 2008.
On July 15, 2008, however, Congress
delayed this program in section 154 of
the Medicare Improvements for Patients
and Providers Act of 2008 (MIPPA).
MIPPA mandated certain changes to the
competitive bidding program which
included, but are not limited to: a delay
of Rounds 1 (competition began in 2009)
and 2 of the program (competition began
in 2011 in 70 specific MSAs); the
exclusion of Puerto Rico and negative
pressure wound therapy from Round 1
and group 3 complex rehabilitative
power wheelchairs from all rounds of
competition; a process for providing
feedback to suppliers regarding missing
financial documentation; and a
requirement for contract suppliers to
disclose to CMS information regarding
subcontracting relationships. Section
154 of the MIPPA specified that the
competition for national mail order
items and services may be phased in
after 2010 and established a rule
requiring that a bidder demonstrate that
its bid covers 50 percent (or higher) of
the types of diabetic testing strips, based
on volume (the ‘‘50 percent rule’’) for
national mail order competitions. As
required by MIPPA, CMS conducted the
competition for the Round 1 Rebid in
2009. The Round 1 Rebid contracts and
prices became effective on January 1,
2011.
The Affordable Care Act, enacted on
March 23, 2010, expanded the Round 2
competition by adding an additional 21
MSAs, bringing the total MSAs for
Round 2 to 91. The competition for
VerDate Mar<15>2010
18:05 May 09, 2013
Jkt 229001
Round 2 began in December 2011. CMS
also began a competition for National
Mail Order of Diabetic Testing Supplies
at the same time as Round 2. The Round
2 and National Mail-Order contracts and
prices have a target implementation date
of July 1, 2013.
The MMA requires the Secretary to recompete contracts not less often than
once every 3 years. Most Round 1 Rebid
contracts will expire on December 31,
2013. (Round 1 Rebid contracts for mailorder diabetic testing supplies ended on
December 31, 2012.) Consequently, we
are currently in the process of recompeting the competitive bidding
contracts in the Round 1 Rebid areas.
The most recent approval for this
information collection request (ICR) was
issued by OMB on October 10, 2012.
Since then, CMS has decided to
sequentially update the paperwork
burden necessary to administer the
program as it expands nationally and
cycles through multiple rounds of
competition. Specifically, we are now
seeking to update our burden estimates
for certain contract maintenance forms
for Round 2 and the national mail-order
competitions. These include Form C
and the Contract Supplier’s Disclosure
of Subcontractors form. We are also
requesting approval of two additional
forms: the Change of Ownership
(CHOW) Purchaser Form and the CHOW
Contract Supplier Notification Form,
which will be utilized in all rounds of
competition. Finally, we are retaining
without change Forms A, B, and D and
their associated burden under this ICR.
We note that the information collection
for Forms A and B is already complete.
We intend to continue use of the forms
in future rounds of competition.
Form Number: CMS–10169 (OCN:
0938–1016). Frequency: Occasionally.
Affected Public: Private Sector (business
or other for-profits) and Individuals or
households. Number of Respondents:
19,035. Total Annual Responses:
19,035. Total Annual Hours: 9,311. (For
policy questions regarding this
collection contact Michael Keane at
410–786–4495. 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.
To be assured consideration,
comments and recommendations for the
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
proposed information collections must
be received by the OMB desk officer at
the address below, no later than 5 p.m.
on June 10, 2013.
OMB, Office of Information and
Regulatory Affairs, Attention: CMS
Desk Officer. Fax Number: (202) 395–
6974. Email:
OIRA_submission@omb.eop.gov.
Dated: May 6, 2013.
Martique Jones,
Deputy Director, Regulations Development
Group,Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2013–11033 Filed 5–9–13; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–R–70, CMS–R–
72, CMS–R–247, CMS–10287, CMS–R–43,
CMS–855(POH), CMS–2552–10, and CMS–
10062]
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: Reinstatement with a change of
a previously approved collection; Title
of Information Collection: Information
Collection Requirements in HSQ–110,
Acquisition, Protection and Disclosure
of Peer review Organization Information
and Supporting Regulations in 42 CFR,
Sections 480.104, 480.105, 480.116, and
480.134; Use: The Peer Review
Improvement Act of 1982 authorizes
quality improvement organizations
AGENCY:
E:\FR\FM\10MYN1.SGM
10MYN1
mstockstill on DSK4VPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 91 / Friday, May 10, 2013 / Notices
(QIOs), formally known as peer review
organizations (PROs), to acquire
information necessary to fulfill their
duties and functions and places limits
on disclosure of the information. The
QIOs are required to provide notices to
the affected parties when disclosing
information about them. These
requirements serve to protect the rights
of the affected parties. The information
provided in these notices is used by the
patients, practitioners and providers to:
obtain access to the data maintained and
collected on them by the QIOs; add
additional data or make changes to
existing QIO data; and reflect in the
QIO’s record the reasons for the QIO’s
disagreeing with an individual’s or
provider’s request for amendment.:
Form Number: CMS–R–70 (OCN: 0938–
0426); Frequency: Reporting—On
occasion; Affected Public: Business or
other for-profits; Number of
Respondents: 400; Total Annual
Responses: 21,200; Total Annual Hours:
42,400. (For policy questions regarding
this collection contact Coles Mercier at
410–786–2112. For all other issues call
410–786–1326.)
2. Type of Information Collection
Request: Reinstatement without change
of a previously approved collection;
Title of Information Collection:
Information Collection Requirements in
42 CFR 478.18, 478.34, 478.36, 478.42,
QIO Reconsiderations and Appeals; Use:
In the event that a beneficiary, provider,
physician, or other practitioner does not
agree with the initial determination of a
Quality Improvement Organization
(QIO) or a QIO subcontractor, it is
within that party’s rights to request
reconsideration. The information
collection requirements at 42 CFR
478.18, 478.34, 478.36, and 478.42,
contain procedures for QIOs to use in
reconsideration of initial
determinations. The information
requirements contained in these
regulations are imposed on QIOs to
provide information to parties
requesting the reconsideration. These
parties will use the information as
guidelines for appeal rights in instances
where issues are actively being
disputed. Form Number: CMS–R–72
(OCN: 0938–0443); Frequency:
Reporting—On occasion; Affected
Public: Individuals or Households and
Business or other for-profit institutions;
Number of Respondents: 2,590; Total
Annual Responses: 5,228; Total Annual
Hours: 2,822. (For policy questions
regarding this collection contact Coles
Mercier at 410–786–2112. For all other
issues call 410–786–1326.)
3. Type of Information Collection
Request: Reinstatement with a change of
a previously approved collection; Title
VerDate Mar<15>2010
18:05 May 09, 2013
Jkt 229001
of Information Collection: Expanded
Coverage for Diabetes Outpatient SelfManagement Training Services and
Supporting Regulations Contained in 42
CFR 410.141, 410.142, 410.143, 410.144,
410.145, 410.146, 414.63; Use:
According to the National Health and
Nutrition Examination Survey
(NHANES), as many as 18.7 percent of
Americans over age 65 are at risk for
developing diabetes. The goals in the
management of diabetes are to achieve
normal metabolic control and reduce
the risk of micro- and macro-vascular
complications. Numerous epidemiologic
and interventional studies point to the
necessity of maintaining good glycemic
control to reduce the risk of the
complications of diabetes. Despite this
knowledge, diabetes remains the leading
cause of blindness, lower extremity
amputations and kidney disease
requiring dialysis. Diabetes and its
complications are primary or secondary
factors in an estimated 9 percent of
hospitalizations (Aubert, RE, et al.,
Diabetes-related hospitalizations and
hospital utilization. In: Diabetes in
America. 2nd ed. National Institutes of
Health, National Institute of Diabetes
and Digestive and Kidney Disease, NIH,
Pub. No 95–1468–1995: 553–570).
Overall, beneficiaries with diabetes are
hospitalized 1.5 times more often than
beneficiaries without diabetes. HCFA–
3002–F ‘‘Expanded Coverage for
Outpatient Diabetes Self-Management
Training and Diabetes Outcome
Measurements’’, provided for uniform
coverage of diabetes outpatient selfmanagement training services. These
services include educational and
training services furnished to a
beneficiary with diabetes by an entity
approved to furnish the services. The
physician or qualified non-physician
practitioner treating the beneficiary’s
diabetes would certify that these
services are needed as part of a
comprehensive plan of care. This rule
established the quality standards that an
entity would be required to meet in
order to participate in furnishing
diabetes outpatient self-management
training services. It set forth payment
amounts that have been established in
consultation with appropriate diabetes
organizations. It implements section
4105 of the Balanced Budget Act of
1997. Form Number: CMS–R–247 (OCN:
0938–0818); Frequency: Recordkeeping
and Reporting—Occasionally; Affected
Public: Business or other for-profit
institutions; Number of Respondents:
5327; Total Annual Responses: 63,924;
Total Annual Hours: 197,542. (For
policy questions regarding this
collection contact Kristin Shifflett at
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
27401
410–786–4133. For all other issues call
410–786–1326.)
4. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Medicare
Quality of Care Complaint Form; Use: In
accordance with Section 1154(a)(14) of
the Social Security Act, Quality
Improvement Organizations (QIOs) are
required to conduct appropriate reviews
of all written complaints submitted by
beneficiaries concerning the quality of
care received. The Medicare Quality of
Care Complaint Form will be used by
Medicare beneficiaries to submit quality
of care complaints. This form will
establish a standard form for all
beneficiaries to utilize and ensure
pertinent information is obtained by
QIOs to effectively process these
complaints. Form Number: CMS–10287
(OCN: 0938–1102); Frequency:
Reporting—Occasionally; Affected
Public: Individuals or Households;
Number of Respondents: 3,500; Total
Annual Responses: 3,500; Total Annual
Hours: 583. (For policy questions
regarding this collection contact Coles
Mercier at 410–786–2112. For all other
issues call 410–786–1326.)
5. Type of Information Collection
Request: Reinstatement with change of a
currently approved collection; Title of
Information Collection: Conditions of
Participation for Portable X-ray
Suppliers and Supporting Regulations
in 42 CFR Sections 486.104, 486.106,
486.110; Use: The requirements
contained in this information collection
request are classified as conditions of
participation or conditions for coverage.
These conditions are based on a
provision specified in law relating to
diagnostic X-ray tests ‘‘furnished in a
place of residence used as the patient’s
home,’’ and are designed to ensure that
each supplier has a properly trained
staff to provide the appropriate type and
level of care, as well as, a safe physical
environment for patients. CMS uses
these conditions to certify suppliers of
portable X-ray services wishing to
participate in the Medicare program.
This is standard medical practice and is
necessary in order to help to ensure the
well-being, safety and quality
professional medical treatment
accountability for each patient. Form
Number: CMS–R–43 (OCN: 0938–0338);
Frequency: Yearly; Affected Public:
Business or other for-profit and Not-forprofit institutions; Number of
Respondents: 578; Total Annual
Responses: 578; Total Annual Hours:
948. (For policy questions regarding this
collections contact Alesia Hovatter at
410–786–6861. For all other issues call
410–786–1326.)
E:\FR\FM\10MYN1.SGM
10MYN1
mstockstill on DSK4VPTVN1PROD with NOTICES
27402
Federal Register / Vol. 78, No. 91 / Friday, May 10, 2013 / Notices
6. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: Annual Report
of Physician-Owned Hospital
Ownership and/or Investment Interest;
Use: Section 6001 of the Affordable Care
Act (ACA) requires Medicare hospitals
to report whether they have any
physician owners including
immediately family members of the
physician.
Currently the CMS 855A captures
basic ownership/managerial information
on providers. The CMS 855A was
revised in July 2011 and a specific
attachment designed to capture
physician-owned hospital ownership
and investment interest data was added
to the form. The attachment is being
removed from the CMS 855A
application because the annual
reporting requirement for physicianowned hospitals is not required for
Medicare enrollment processing. This
physician-owned hospital data
collection is mandated to be reported on
an annual basis. Additionally, the ACA
prohibits the expansion of current
physician-owned hospitals and banned
the establishment of new ones making
the CMS 855A the improper method to
collect this required annual report.
CMS is requesting the physicianowned hospital ownership information,
investment information or both,
previously collected in Attachment 1 of
the CMS 855A enrollment application to
become a stand-alone form with a
unique OMB number for the following
reasons:
• The physician-owned data
collection has a small targeted audience
of approximately 140 physician-owned
hospitals nationwide.
• The physician-owned data
collection is required annually, as noted
above.
• The data required under section
6001 is more specific than the data
currently collected on the CMS–855A
provider enrollment application.
• The data is not required for
Medicare provider enrollment purposes.
Form Number: CMS–855 (POH)(OCN:
0938-New); Frequency: Reporting—
Yearly; Affected Public: Private Sector—
Business or other for-profits and not-forprofit institutions; Number of
Respondents: 140; Total Annual
Responses: 140; Total Annual Hours:
140. (For policy questions regarding this
collection contact Kim McPhillips at
410–786–5374. For all other issues call
410–786–1326.)
7. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Hospital and
VerDate Mar<15>2010
18:05 May 09, 2013
Jkt 229001
Health Care Complexes and Supporting
Regulations in 42 CFR 413.20 and
413.24; Use: Medicare Part A
institutional providers must provide
adequate cost data to receive Medicare
reimbursement (42 CFR 413.24(a)).
Providers must submit the cost data to
their Medicare Fiscal Intermediary (FI)/
Medicare Administrative Contractor
(MAC) through the Medicare cost report
(MCR). We are submitting a revision of
the Hospital and Hospital Health Care
Complex Cost Report, Form CMS–2552–
10. Form CMS 2552–10 is used by
hospitals participating in the Medicare
program to report the health care costs
to determine the amount of
reimbursable costs for services rendered
to Medicare beneficiaries. The revisions
were caused by legislative requirements
in the Patient Protection and Affordable
Care Act of 2010 and the Temporary
Payroll Tax Cut Continuation Act of
2011. Form Number: CMS–2552–10
(OCN: 0938–0050); Frequency:
Reporting—Yearly; Affected Public:
Private Sector—Business or other forprofits and not-for-profit institutions;
Number of Respondents: 6,171; Total
Annual Responses: 6,171; Total Annual
Hours: 4,153,083. (For policy questions
regarding this collection contact Nadia
Massuda at 410–786–5834. For all other
issues call 410–786–1326.)
8. Type of Information Collection
Request: Reinstatement with change of a
previously approved collection. Title of
Information Collection: Collection of
Diagnostic Data from Medicare
Advantage Organizations for Risk
Adjusted Payments. Use: CMS will use
the data to make risk adjusted payment
under Parts C. MA and MA–PD plans
will use the data to develop their Parts
C bids. As required by law, CMS also
annually publishes the risk adjustment
factors for plans and other interested
entities in the Advance Notice of
Methodological Changes for MA
Payment Rates (every February) and the
Announcement of Medicare Advantage
Payment Rates (every April). Lastly,
CMS issues monthly reports to each
individual plan that contains the CMS–
HCC and RxHCC models’ output and the
risk scores and reimbursements for each
beneficiary that is enrolled in their plan.
Form Number: CMS–10062 (OMB 0938–
0838). Frequency: Quarterly. Affected
Public: Private Sector (business or other
for-profit and not-for-profit institutions).
Number of Respondents: 766. Total
Annual Responses: 830,000. Total
Annual Hours: 40,650. (For policy
questions regarding this collection
contact Michael Massimini at 410–786–
1566. For all other issues call 410–786–
1326.)
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
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 July 9, 2013:
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: May 6, 2013.
Martique Jones,
Deputy Director, Regulations Development
Group, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2013–11035 Filed 5–9–13; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–1181]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medicated Feed
Mill License Application; Extension
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
SUMMARY:
E:\FR\FM\10MYN1.SGM
10MYN1
]]>Agencies
[Federal Register Volume 78, Number 91 (Friday, May 10, 2013)]
[Notices]
[Pages 27400-27402]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-11035]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-R-70, CMS-R-72, CMS-R-247, CMS-10287, CMS-R-
43, CMS-855(POH), CMS-2552-10, and CMS-10062]
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: Reinstatement with a
change of a previously approved collection; Title of Information
Collection: Information Collection Requirements in HSQ-110,
Acquisition, Protection and Disclosure of Peer review Organization
Information and Supporting Regulations in 42 CFR, Sections 480.104,
480.105, 480.116, and 480.134; Use: The Peer Review Improvement Act of
1982 authorizes quality improvement organizations
[[Page 27401]]
(QIOs), formally known as peer review organizations (PROs), to acquire
information necessary to fulfill their duties and functions and places
limits on disclosure of the information. The QIOs are required to
provide notices to the affected parties when disclosing information
about them. These requirements serve to protect the rights of the
affected parties. The information provided in these notices is used by
the patients, practitioners and providers to: obtain access to the data
maintained and collected on them by the QIOs; add additional data or
make changes to existing QIO data; and reflect in the QIO's record the
reasons for the QIO's disagreeing with an individual's or provider's
request for amendment.: Form Number: CMS-R-70 (OCN: 0938-0426);
Frequency: Reporting--On occasion; Affected Public: Business or other
for-profits; Number of Respondents: 400; Total Annual Responses:
21,200; Total Annual Hours: 42,400. (For policy questions regarding
this collection contact Coles Mercier at 410-786-2112. For all other
issues call 410-786-1326.)
2. Type of Information Collection Request: Reinstatement without
change of a previously approved collection; Title of Information
Collection: Information Collection Requirements in 42 CFR 478.18,
478.34, 478.36, 478.42, QIO Reconsiderations and Appeals; Use: In the
event that a beneficiary, provider, physician, or other practitioner
does not agree with the initial determination of a Quality Improvement
Organization (QIO) or a QIO subcontractor, it is within that party's
rights to request reconsideration. The information collection
requirements at 42 CFR 478.18, 478.34, 478.36, and 478.42, contain
procedures for QIOs to use in reconsideration of initial
determinations. The information requirements contained in these
regulations are imposed on QIOs to provide information to parties
requesting the reconsideration. These parties will use the information
as guidelines for appeal rights in instances where issues are actively
being disputed. Form Number: CMS-R-72 (OCN: 0938-0443); Frequency:
Reporting--On occasion; Affected Public: Individuals or Households and
Business or other for-profit institutions; Number of Respondents:
2,590; Total Annual Responses: 5,228; Total Annual Hours: 2,822. (For
policy questions regarding this collection contact Coles Mercier at
410-786-2112. For all other issues call 410-786-1326.)
3. Type of Information Collection Request: Reinstatement with a
change of a previously approved collection; Title of Information
Collection: Expanded Coverage for Diabetes Outpatient Self-Management
Training Services and Supporting Regulations Contained in 42 CFR
410.141, 410.142, 410.143, 410.144, 410.145, 410.146, 414.63; Use:
According to the National Health and Nutrition Examination Survey
(NHANES), as many as 18.7 percent of Americans over age 65 are at risk
for developing diabetes. The goals in the management of diabetes are to
achieve normal metabolic control and reduce the risk of micro- and
macro-vascular complications. Numerous epidemiologic and interventional
studies point to the necessity of maintaining good glycemic control to
reduce the risk of the complications of diabetes. Despite this
knowledge, diabetes remains the leading cause of blindness, lower
extremity amputations and kidney disease requiring dialysis. Diabetes
and its complications are primary or secondary factors in an estimated
9 percent of hospitalizations (Aubert, RE, et al., Diabetes-related
hospitalizations and hospital utilization. In: Diabetes in America. 2nd
ed. National Institutes of Health, National Institute of Diabetes and
Digestive and Kidney Disease, NIH, Pub. No 95-1468-1995: 553-570).
Overall, beneficiaries with diabetes are hospitalized 1.5 times more
often than beneficiaries without diabetes. HCFA-3002-F ``Expanded
Coverage for Outpatient Diabetes Self-Management Training and Diabetes
Outcome Measurements'', provided for uniform coverage of diabetes
outpatient self-management training services. These services include
educational and training services furnished to a beneficiary with
diabetes by an entity approved to furnish the services. The physician
or qualified non-physician practitioner treating the beneficiary's
diabetes would certify that these services are needed as part of a
comprehensive plan of care. This rule established the quality standards
that an entity would be required to meet in order to participate in
furnishing diabetes outpatient self-management training services. It
set forth payment amounts that have been established in consultation
with appropriate diabetes organizations. It implements section 4105 of
the Balanced Budget Act of 1997. Form Number: CMS-R-247 (OCN: 0938-
0818); Frequency: Recordkeeping and Reporting--Occasionally; Affected
Public: Business or other for-profit institutions; Number of
Respondents: 5327; Total Annual Responses: 63,924; Total Annual Hours:
197,542. (For policy questions regarding this collection contact
Kristin Shifflett at 410-786-4133. For all other issues call 410-786-
1326.)
4. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Medicare Quality
of Care Complaint Form; Use: In accordance with Section 1154(a)(14) of
the Social Security Act, Quality Improvement Organizations (QIOs) are
required to conduct appropriate reviews of all written complaints
submitted by beneficiaries concerning the quality of care received. The
Medicare Quality of Care Complaint Form will be used by Medicare
beneficiaries to submit quality of care complaints. This form will
establish a standard form for all beneficiaries to utilize and ensure
pertinent information is obtained by QIOs to effectively process these
complaints. Form Number: CMS-10287 (OCN: 0938-1102); Frequency:
Reporting--Occasionally; Affected Public: Individuals or Households;
Number of Respondents: 3,500; Total Annual Responses: 3,500; Total
Annual Hours: 583. (For policy questions regarding this collection
contact Coles Mercier at 410-786-2112. For all other issues call 410-
786-1326.)
5. Type of Information Collection Request: Reinstatement with
change of a currently approved collection; Title of Information
Collection: Conditions of Participation for Portable X-ray Suppliers
and Supporting Regulations in 42 CFR Sections 486.104, 486.106,
486.110; Use: The requirements contained in this information collection
request are classified as conditions of participation or conditions for
coverage. These conditions are based on a provision specified in law
relating to diagnostic X-ray tests ``furnished in a place of residence
used as the patient's home,'' and are designed to ensure that each
supplier has a properly trained staff to provide the appropriate type
and level of care, as well as, a safe physical environment for
patients. CMS uses these conditions to certify suppliers of portable X-
ray services wishing to participate in the Medicare program. This is
standard medical practice and is necessary in order to help to ensure
the well-being, safety and quality professional medical treatment
accountability for each patient. Form Number: CMS-R-43 (OCN: 0938-
0338); Frequency: Yearly; Affected Public: Business or other for-profit
and Not-for-profit institutions; Number of Respondents: 578; Total
Annual Responses: 578; Total Annual Hours: 948. (For policy questions
regarding this collections contact Alesia Hovatter at 410-786-6861. For
all other issues call 410-786-1326.)
[[Page 27402]]
6. Type of Information Collection Request: New collection (Request
for a new OMB control number); Title of Information Collection: Annual
Report of Physician-Owned Hospital Ownership and/or Investment
Interest; Use: Section 6001 of the Affordable Care Act (ACA) requires
Medicare hospitals to report whether they have any physician owners
including immediately family members of the physician.
Currently the CMS 855A captures basic ownership/managerial
information on providers. The CMS 855A was revised in July 2011 and a
specific attachment designed to capture physician-owned hospital
ownership and investment interest data was added to the form. The
attachment is being removed from the CMS 855A application because the
annual reporting requirement for physician-owned hospitals is not
required for Medicare enrollment processing. This physician-owned
hospital data collection is mandated to be reported on an annual basis.
Additionally, the ACA prohibits the expansion of current physician-
owned hospitals and banned the establishment of new ones making the CMS
855A the improper method to collect this required annual report.
CMS is requesting the physician-owned hospital ownership
information, investment information or both, previously collected in
Attachment 1 of the CMS 855A enrollment application to become a stand-
alone form with a unique OMB number for the following reasons:
The physician-owned data collection has a small targeted
audience of approximately 140 physician-owned hospitals nationwide.
The physician-owned data collection is required annually,
as noted above.
The data required under section 6001 is more specific than
the data currently collected on the CMS-855A provider enrollment
application.
The data is not required for Medicare provider enrollment
purposes.
Form Number: CMS-855 (POH)(OCN: 0938-New); Frequency: Reporting--
Yearly; Affected Public: Private Sector--Business or other for-profits
and not-for-profit institutions; Number of Respondents: 140; Total
Annual Responses: 140; Total Annual Hours: 140. (For policy questions
regarding this collection contact Kim McPhillips at 410-786-5374. For
all other issues call 410-786-1326.)
7. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Hospital and
Health Care Complexes and Supporting Regulations in 42 CFR 413.20 and
413.24; Use: Medicare Part A institutional providers must provide
adequate cost data to receive Medicare reimbursement (42 CFR
413.24(a)). Providers must submit the cost data to their Medicare
Fiscal Intermediary (FI)/Medicare Administrative Contractor (MAC)
through the Medicare cost report (MCR). We are submitting a revision of
the Hospital and Hospital Health Care Complex Cost Report, Form CMS-
2552-10. Form CMS 2552-10 is used by hospitals participating in the
Medicare program to report the health care costs to determine the
amount of reimbursable costs for services rendered to Medicare
beneficiaries. The revisions were caused by legislative requirements in
the Patient Protection and Affordable Care Act of 2010 and the
Temporary Payroll Tax Cut Continuation Act of 2011. Form Number: CMS-
2552-10 (OCN: 0938-0050); Frequency: Reporting--Yearly; Affected
Public: Private Sector--Business or other for-profits and not-for-
profit institutions; Number of Respondents: 6,171; Total Annual
Responses: 6,171; Total Annual Hours: 4,153,083. (For policy questions
regarding this collection contact Nadia Massuda at 410-786-5834. For
all other issues call 410-786-1326.)
8. Type of Information Collection Request: Reinstatement with
change of a previously approved collection. Title of Information
Collection: Collection of Diagnostic Data from Medicare Advantage
Organizations for Risk Adjusted Payments. Use: CMS will use the data to
make risk adjusted payment under Parts C. MA and MA-PD plans will use
the data to develop their Parts C bids. As required by law, CMS also
annually publishes the risk adjustment factors for plans and other
interested entities in the Advance Notice of Methodological Changes for
MA Payment Rates (every February) and the Announcement of Medicare
Advantage Payment Rates (every April). Lastly, CMS issues monthly
reports to each individual plan that contains the CMS-HCC and RxHCC
models' output and the risk scores and reimbursements for each
beneficiary that is enrolled in their plan. Form Number: CMS-10062 (OMB
0938-0838). Frequency: Quarterly. Affected Public: Private Sector
(business or other for-profit and not-for-profit institutions). Number
of Respondents: 766. Total Annual Responses: 830,000. Total Annual
Hours: 40,650. (For policy questions regarding this collection contact
Michael Massimini at 410-786-1566. 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 July 9, 2013:
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: May 6, 2013.
Martique Jones,
Deputy Director, Regulations Development Group, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2013-11035 Filed 5-9-13; 8:45 am]
BILLING CODE 4120-01-P
