Tuesday, May 14, 2013

Expanded Coverage for Diabetes Outpatient Self- Management Training Services and Supporting Regulations (CMS-R-247)


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
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Federal Register /Vol. 78, No. 91 / Friday, May 10, 2013 /Notices 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 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
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.)
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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
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.)
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web site
address at http://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 http://
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

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