Agency Information Collection Activities: Proposed Collection; Comment Request, 13415-13418 [2011-5684]
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Federal Register / Vol. 76, No. 48 / Friday, March 11, 2011 / Notices
Atlanta, Georgia 30333, Telephone: (404)
498–2733.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Dated: March 7, 2011.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2011–5623 Filed 3–10–11; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10367]
Agency Information Collection
Activities: Submission for OMB
Review; 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), Department of Health
and Human Services, 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 function;
(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: New collection (Request for a
new OMB Control Number); Title of
Information Collection: Medicaid State
Plan Preprint for Use by States When
Implementing Section 6505 of the
[Patient Protection and] Affordable Care
Act; Use: CMS has developed a
Medicaid State Plan Preprint for use by
States and specifically to support the
January 1, 2011, mandate of the
prohibition on payments outside of the
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United States. The preprint follows the
format and requested information from
prior preprints provided to the States by
CMS and provides a placeholder and
assurance of compliance with section
1902(a) of the Social Security Act; Form
Number: CMS–10367 (OMB#: 0938–
NEW); Frequency: Occasionally;
Affected Public: State, Local, or Tribal
Governments; Number of Respondents:
56; Total Annual Responses: 56; Total
Annual Hours: 5. (For policy questions
regarding this collection contact Carla
Ausby at 410–786–2153. 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
proposed information collections must
be received by the OMB desk officer at
the address below, no later than 5 p.m.
on April 11, 2011: OMB, Office of
Information and Regulatory Affairs,
Attention: CMS Desk Officer, Fax
Number: (202) 395–6974, E-mail:
OIRA_submission@omb.eop.gov.
Dated: March 4, 2011.
Martique Jones,
Director, Regulations Development Group,
Division B, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2011–5685 Filed 3–10–11; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–2540–10, CMS–
10115, CMS–10136, CMS–10260, CMS–
10320, CMS–10381, CMS–855(S), CMS–
855(A, B, I, R) and CMS–855(O)]
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.
AGENCY:
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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 of
Information Collection: Skilled Nursing
Facility and Skilled Nursing Facility
Health Care Complex Cost Report. Use:
Form CMS 2540–10 is used by Skilled
Nursing Facilities (SNFs) and Skilled
Nursing Facility Complexes
participating in the Medicare program to
report the health care costs to determine
the amount of reimbursable costs for
services rendered to Medicare
beneficiaries. It is required under
sections 1815(a), 1833(e) and
1861(v)(1)(A) of the Social Security Act
(42 U.S.C. 1395g) to submit annual
information to achieve settlement of
costs for health care services rendered to
Medicare beneficiaries. The revision is
due to new reporting requirements as
mandated by the Patient Protection and
Affordability Act section 6104. The
Patient Protection and Affordable Care
Act, § 6104(1) of Public Law 111–148
amended § 1888(f) of the Social Security
Act (‘‘Reporting of Direct Care
Expenditures’’), requires SNFs to
separately report expenditures for wages
and benefits for direct care staff
(registered nurses, licensed professional
nurses, certified nurse assistants, and
other medical and therapy staff). In
implementing these changes Worksheet
S–3, part V was added. With the
addition of this worksheet the average
record keeping time for each provider
will be increased by 5 hours and the
average reporting time by 1 hour. Form
Number: CMS–2540–10 (OMB#: 0938–
0463); Frequency: Yearly; Affected
Public: Private Sector; Business or other
for-profit and not-for-profit institutions;
Number of Respondents: 15,071; Total
Annual Responses: 15,071; Total
Annual Hours: 3,171,602 (For policy
questions regarding this collection
contact Amelia Citerone at 410–786–
3901. For all other issues call 410–786–
1326.)
2. Type of Information Collection
Request: Extension of currently
approved collection; Title of
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Information Collection: Federal
Reimbursement of Emergency Health
Services Furnished to Undocumented
Aliens (Sections 1011) Provider
Enrollment Application; Use: Section
1011 of the Medicare Prescription Drug,
Improvement, and Modernization Act of
2003, provides that the Secretary will
establish a process (i.e., enrollment and
claims payment) for eligible providers to
request payment. The Secretary must
directly pay hospitals, physicians and
ambulance providers (including Indian
Health Service, Indian Tribe and Tribal
organizations) for their otherwise unreimbursed costs of providing services
required by section 1867 of the Social
Security Act (EMTALA) and related
hospital inpatient, outpatient and
ambulance services. CMS will use the
application information to administer
this health services program and
establish an audit process. The Federal
Reimbursement of Emergency Health
Services Furnished to Undocumented
Aliens (Sections 1011) Provider
Enrollment Application has been
revised. For a list of these revisions,
refer to the summary of changes
document.
Form Number: CMS–10115 (OMB#
0938–0929); Frequency: On occasion;
Affected Public: Private sector—
Business or other for-profit and Not-forprofit institutions; Number of
Respondents: 5,000; Total Annual
Responses: 5,000; Total Annual Hours:
2,999.
3. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Medicare
Demonstration Ambulatory Care Quality
Measure Performance Assessment Tool
(‘‘PAT’’); Use: This request is to cover a
modification of an existing, approved
data collection effort with a new secure
Web based system. This system will also
provide a platform for developing tools
to collect clinical quality data for future
demonstrations and programs. There is
no increase in burden. In fact, because
all of the practices submitting data will
have Electronic Health Records (EHRs),
it is likely that the originally estimated
burden will decrease over the coming
years of the demonstration. CMS is
requesting an extension of the currently
approved tool for the collection of
ambulatory care clinical performance
measure data.
The data will be used to continue
implementation of two Congressionally
mandated demonstration projects (the
Physician Group Practice (PGP)
Demonstration and the Medicare Care
Management Performance (MCMP)
Demonstration); also the support data
collection under the new EHR
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Demonstration. Each of these
demonstrations, test new payment
methods for improving the quality and
efficiency of health care services
delivered to Medicare fee-for-service
beneficiaries, especially those with
chronic conditions that account for a
disproportionate share of Medicare
expenditures. In addition, the MCMP
and EHR demonstration specifically
encourage the adoption of electronic
health records systems as a vehicle for
improving how health care is delivered.
4. Type of Information Collection
Request: Extension without change;
Title of Information Collection:
Medicare Advantage and Prescription
Drug Program: Final Marketing
Provisions CFR 422.111(a)(3) and
423.128 (a)(3). Use: Medicare Advantage
(MA) plans must provide notice to plan
members of impending changes to plan
benefits, premiums and copays in the
coming year so that members will be in
the best position to make an informed
choice on continued enrollment or
disenrollment from that plan at least 15
days before the Annual Election Period
(AEP). Beginning 2009, organizations
will be required to notify plan members
of the coming year changes using a
combined standardized document at the
time of enrollment and annually
thereafter.
Section 422.111 requires, to the extent
that a MA plan has a Web site, annual
notification through the Web site of
written, hard copy notification sent to
the beneficiaries. Section 423.128
requires that a part D plan have
mechanisms for providing specific
information on a timely basis to current
and prospective enrollees upon request.
These mechanisms include, Internet
Web site that includes information on
part D plan description. MA
organizations (formerly M+C
organizations) and Prescription Drug
Plan Sponsors use the information to
comply with the eligibility requirements
and the MA and part D contract
requirements. CMS will use this
information to ensure that correct
information is disclosed to Medicare
beneficiaries, both potential enrollees
and enrollees. Form Number: CMS–
10260 (OMB#: 0938–1051); Frequency:
Reporting—Yearly; Affected Public:
Business or other for-profits; Number of
Respondents: 790; Total Annual
Responses: 790; Total Annual Hours:
9,480. (For policy questions regarding
this collection contact Camille Brown at
410–786–0274. For all other issues call
410–786–1326.)
5. Type of Information Collection
Request: Reinstatement of previously
approved collection; Title of
Information Collection: Health Care
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Reform Insurance Web Portal
Requirements 45 CFR part 159; Use: In
compliance with the requirement of
section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the Center for
Consumer Information and Insurance
Oversight, Centers for Medicare and
Medicaid Services, Department of
Health and Human Services, is
publishing the following summary of a
proposed information collection request
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.
This information collection is
mandated by Sections 1103 and 10102
of The Patient Protection and
Affordability Care Act, Public Law 111–
148 (ACA). Once all of the information
is collected from insurance issuers of
major medical health insurance (hereon
referred to as issuers) and other affected
parties, it will be processed for will
display at https://www.healthcare.gov
with quarterly refreshes. The
information that is provided will help
the general public make educated
decisions about organizations providing
private health care insurance.
In accordance with the provisions of
the ACA referenced above, the U.S.
Department of Health and Human
Services created a Web site called
healthcare.gov to meet these and other
provisions of the law, and data
collection was conducted for six months
based upon an emergency information
collection request. The interim final rule
published on May 5, 2010 served as the
emergency Federal Register Notice for
the prior Information Collection Request
(ICR). The Office of Management and
Budget (OMB) reviewed this ICR under
emergency processing and approved the
ICR on April 30, 2010. The CCIIO will
be submitting a new ICR to OMB for
review and approval in accordance with
the Paperwork Reduction Act of 1995.
The proposed information collection is
published to obtain comments from the
public and affected agencies.
CCIIO is currently updating a system
(hereon referred to as Web portal) where
State Departments of Insurance and
issuers will log in to using a custom
user ID and password validation. The
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States will be tasked to provide
information on issuers in their State and
various Web sites maintained for
consumers. The issuers will be tasked to
provide information on their major
medical insurance products and plans.
They will ultimately be given the choice
to download a basic information
template to enter data then upload into
the Web portal; to manually enter data
within the Web portal itself; or to
submit xml files containing their
information. Once the States and issuers
submit their data, they will receive an
e-mail notifying them of any errors, and
that their submission was received.
CCIIO is mandating the issuers verify
and update their information on a
quarterly basis and is requesting the
States to verify State submitted
information on an annual basis. In the
event that an issuer enhances its
existing plans, proposes new plans, or
deactivates plans, the organization
would be required to update the
information in the Web portal. Changes
occurring during the three month
quarterly periods will be allowed
utilizing effective dates for both the
plans and rates associated with the
plans. Information that is to be collected
from State high risk pools will be
collected from The National Association
of State Comprehensive Health
Insurance Plans (NASCHIP) at this time.
Updates to this information may be
submitted voluntarily.
The estimated hour burden on issuers
for the Plan Finder data collection in the
first year is estimated as 84,600 total
burden hours, or 113 hours per
organization. This estimate is based on
an assumed average of 450 individual
plan issuers and 700 small group plan
issuers per each of the four quarterly
collections. It includes 30 hours per
organization for training and
communication. Additionally, for each
of the issuers it includes 10 hours of
preparation time, one hour of login and
upload time, two hours of
troubleshooting and data review and
one half hour for attestation per
organization per quarterly refresh.
The estimated hour burden on the
States is informed by the fact that they
have already submitted the data once
and only need to update. The overall
hours estimate is 575, or 11.5 per
Department of Insurance. This is
premised on 2 hours of training and
communication, 8 hours for data
collection, and one half hour of
submission. Form Number: CMS–10320
(OMB#: 0938–1086); Frequency:
Reporting—Annually/Quarterly;
Affected Public: Business or other forprofits and States; Number of
Respondents: 801; Total Annual
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Responses: 3,051; Total Annual Hours:
85,175. (For policy questions regarding
this collection contact Beth Liu at 301–
492–4268. For all other issues call 410–
786–1326.)
6. Type of Information Collection
Request: New collection; Title of
Information Collection: Version 5010/
ICD–10 Industry Readiness Assessment
Use: The Health Insurance Portability
and Accountability Act of 1996 (HIPAA)
requires the Secretary of HHS to adopt
transaction standards that covered
entities are required to use when
electronically conducting certain health
care administrative transactions, such as
claims, remittance, eligibility and
claims status requests and responses.
Accordingly, on January 16, 2009, HHS
published final rules adopting by
regulation two sets of standards for
HIPAA transactions: Version 5010
standards for eight types of electronic
health care transactions (claims,
eligibility inquiries, remittance advices,
etc.) and ICD–10 code set standards. The
final rules set compliance dates of
January 1, 2012 for Version 5010
standards and October 1, 2013 for ICD–
10 standards. HIPAA transactions not
meeting the standards by those dates
will be rejected. The final rules also
outlined interim milestones that
organizations should meet in order to
achieve compliance by the required
dates. For Version 5010, these interim
milestones include completing internal
testing and being able to send and
receive compliant transactions by
December 2010, commencing external
testing with trading partners by January
2011, and completing that testing and
moving into production by the
compliance date of January 1, 2012.
Entities cannot implement ICD–10
standards until they are in compliance
with Version 5010; the interim
milestone for ICD–10 is to begin
compliance activities (gap analysis,
design, development, internal testing)
by January 2011.
CMS has developed an education and
communication campaign to support the
adoption of and transition to Version
5010 and ICD–10. The education and
communication activities will be
targeted towards the millions of
professionals across the health care
industry who must take steps to prepare
for the implementation of the new codes
and transaction standards. CMS is
requesting Office of Management and
Budget (OMB) approval to conduct
survey research to monitor the health
care industry’s awareness of, and
preparation for, the transition to Version
5010 and ICD–10. The aggregated data
obtained through the survey will help
inform CMS outreach and education
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efforts to help affected entities (health
care providers, health plans,
clearinghouses, and then vendors who
service them) meet interim milestones
and achieve timely compliance so that
they can continue to process HIPAA
transactions without interruption.
CMS has contracted to conduct a
tracking survey of populations charged
with implementing Version 5010 and
ICD–10 electronic transaction
processing, specifically payers (health
insurance plans and managed care
organizations), providers (hospitals and
primary care providers), and vendors
(software providers, third-party billers
and clearinghouses). A selfadministered Web-based survey will be
the data collection. The data collection
field period is expected to be four weeks
in Summer 2011. Form Number: CMS–
10381 (OMB#: 0938–NEW); Frequency:
Once; Affected Public: Business or other
for-profits and Not-for-profit
institutions; Number of Respondents:
600; Total Annual Responses: 600; Total
Annual Hours: 150. (For policy
questions regarding this collection
contact Rosali Topper at 410–786–7260.
For all other issues call 410–786–1326.)
7. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Medicare
Durable Medical Equipment Supplier
Enrollment Application Use: The
primary function of the CMS 855S
DMEPOS supplier enrollment
application is to gather information
from a supplier that tells us who it is,
whether it meets certain qualifications
to be a health care supplier, where it
renders its services or supplies, the
identity of the owners of the enrolling
entity, and information necessary to
establish the correct claims payment.
The goal of evaluating and revising the
CMS 855S DMEPOS supplier
enrollment application is to simplify
and clarify the information collection
without jeopardizing our need to collect
specific information. Additionally,
periodic revisions are necessary to
incorporate new regulatory
requirements. The goal of this revision
of the CMS 855S is to incorporate new
regulatory provisions found at 42 CFR
424.57(c) (1 through 30) and 42 CFR
424.58. These revisions will allow CMS
to be in compliance with the above
stated regulations implementing new
quality standards for DMEPOS
suppliers, including accreditation
requirements. This revision will also
incorporate new supplier standard
regulations found in the final regulation
that published on August 27, 2010 (75
FR 52629–52649). Form Number: CMS–
855(S) (OMB#: 0938–1056); Frequency:
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Yearly; Affected Public: Private Sector;
Business or other for-profit and not-forprofit institutions; Number of
Respondents: 140,290; Total Annual
Responses: 140,290; Total Annual
Hours: (For policy questions regarding
this collection contact Kim McPhillips
at 410–786–5374. For all other issues
call 410–786–1326.)
8. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Medicare
Enrollment Application Use: The
primary function of the CMS–855
Medicare enrollment application is to
gather information from a provider or
supplier that tells us who it is, whether
it meets certain qualifications to be a
health care provider or supplier, where
it practices or renders its services, the
identity of the owners of the enrolling
entity, and other information necessary
to establish correct claims payments.
The goal of this submission is to address
the following issues. The CMS–855A
enrollment form currently captures
ownership/managerial information on
providers. The data required under
sections 6401 and 6001, however, is
more specific than that currently
obtained on the CMS–855A. CMS will
therefore create four attachments to the
CMS–855A—two for SNFs and the other
two for physician-owned hospitals—to
secure this information. In addition to
the application changes triggered by
ACA, CMS is making other revisions to
the forms as well. Form Number: CMS–
855 (A, B, I, R) (OMB#: 0938–0685);
Frequency: Yearly; Affected Public:
Private Sector; Business or other forprofit and not-for-profit institutions;
Number of Respondents: 440,450; Total
Annual Responses: 440,450; Total
Annual Hours: 842,810 (For policy
questions regarding this collection
contact Kim McPhillips at 410–786–
5374. For all other issues call 410–786–
1326.)
9. Type of Information Collection
Request: New collection; Title of
Information Collection: Medicare
Enrollment Application for Eligible
Ordering and Referring Physicians and
Non-physician Practices Use: CMS is
adding a new CMS–855 Medicare
Enrollment Application (CMS 855O—
Medicare Enrollment Application for
Ordering and Referring Physicians
only). CMS has found that many
providers and suppliers who are not
enrolled in Medicare are ordering and
referring physicians for Medicare
enrolled providers and suppliers. The
ordering and referring data field on the
CMS 1500 claims submission form
requires an ordering or referring
physician to have a Medicare
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identification number. Without an
ordering or referring physician, specific
types of claims submitted by Medicare
approved providers and suppliers are
rejected by Medicare Administrative
Contractors (MAC) as required by
Medicare regulation. Therefore, if an
ordering or referring physician does not
participate in the Medicare program, but
orders or refers his/her patients to a
Medicare provider or supplier, the claim
submitted by the Medicare provider or
supplier for the given ordered or
referred service is automatically rejected
by the MAC. The CMS 855O allows a
physician to receive a Medicare
identification number (without being
approved for billing privileges) for the
sole purpose of ordering and referring
beneficiaries to Medicare approved
providers and suppliers. This new
Medicare application form allows
physicians who do not provide services
to Medicare beneficiaries to be given a
Medicare identification number without
having to supply all the data required
for the submission of Medicare claims.
It also allows the Medicare program to
identify ordering and referring
physicians without having to validate
the amount of data necessary to
determine claims payment eligibility
(such as banking information), while
continuing to identify the physician’s
credentials as valid for ordering and
referring purposes. Form Number:
CMS–855(O) (OMB#: 0938–NEW0685);
Frequency: Yearly; Affected Public:
Private Sector; Business or other forprofit and not-for-profit institutions;
Number of Respondents: 48,000; Total
Annual Responses: 48,000; Total
Annual Hours: 46,000 (For policy
questions regarding this collection
contact Kim McPhillips at 410–786–
5374. 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
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 at 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 May 10, 2011:
1. Electronically. You may submit
your comments electronically to https://
www.regulations.gov. Follow the
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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: March 4, 2011.
Martique Jones,
Director, Regulations Development Group,
Division B, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2011–5684 Filed 3–10–11; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3246–N]
Medicare Program; Meeting of the
Medicare Evidence Development and
Coverage Advisory Committee, May
11, 2011
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice of meeting.
AGENCY:
This notice announces that a
public meeting of the Medicare
Evidence Development & Coverage
Advisory Committee (MEDCAC)
(‘‘Committee’’). The Committee generally
provides advice and recommendations
concerning the adequacy of scientific
evidence needed to determine whether
certain medical items and services can
be covered under the Medicare statute.
This meeting will focus on the currently
available evidence regarding the
outcomes associated with the use of
unilateral and bilateral cochlear implant
technology for hearing loss. This
meeting is open to the public in
accordance with the Federal Advisory
Committee Act (5 U.S.C. App. 2, section
10(a)).
DATES: Meeting Date: The public
meeting will be held on Wednesday,
May 11, 2011 from 7:30 a.m. until 4:30
p.m., eastern daylight time (e.d.t.).
Deadline for Submission of Written
Comments: Written comments must be
received at the address specified in the
ADDRESSES section of this notice by 5
p.m. e.d.t., Monday, April 11, 2011.
Once submitted, all comments are final.
Deadlines for Speaker Registration
and Presentation Materials: The
SUMMARY:
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11MRN1
Agencies
[Federal Register Volume 76, Number 48 (Friday, March 11, 2011)]
[Notices]
[Pages 13415-13418]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-5684]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-2540-10, CMS-10115, CMS-10136, CMS-10260,
CMS-10320, CMS-10381, CMS-855(S), CMS-855(A, B, I, R) and CMS-855(O)]
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 of Information Collection: Skilled Nursing
Facility and Skilled Nursing Facility Health Care Complex Cost Report.
Use: Form CMS 2540-10 is used by Skilled Nursing Facilities (SNFs) and
Skilled Nursing Facility Complexes participating in the Medicare
program to report the health care costs to determine the amount of
reimbursable costs for services rendered to Medicare beneficiaries. It
is required under sections 1815(a), 1833(e) and 1861(v)(1)(A) of the
Social Security Act (42 U.S.C. 1395g) to submit annual information to
achieve settlement of costs for health care services rendered to
Medicare beneficiaries. The revision is due to new reporting
requirements as mandated by the Patient Protection and Affordability
Act section 6104. The Patient Protection and Affordable Care Act, Sec.
6104(1) of Public Law 111-148 amended Sec. 1888(f) of the Social
Security Act (``Reporting of Direct Care Expenditures''), requires SNFs
to separately report expenditures for wages and benefits for direct
care staff (registered nurses, licensed professional nurses, certified
nurse assistants, and other medical and therapy staff). In implementing
these changes Worksheet S-3, part V was added. With the addition of
this worksheet the average record keeping time for each provider will
be increased by 5 hours and the average reporting time by 1 hour. Form
Number: CMS-2540-10 (OMB: 0938-0463); Frequency: Yearly;
Affected Public: Private Sector; Business or other for-profit and not-
for-profit institutions; Number of Respondents: 15,071; Total Annual
Responses: 15,071; Total Annual Hours: 3,171,602 (For policy questions
regarding this collection contact Amelia Citerone at 410-786-3901. For
all other issues call 410-786-1326.)
2. Type of Information Collection Request: Extension of currently
approved collection; Title of
[[Page 13416]]
Information Collection: Federal Reimbursement of Emergency Health
Services Furnished to Undocumented Aliens (Sections 1011) Provider
Enrollment Application; Use: Section 1011 of the Medicare Prescription
Drug, Improvement, and Modernization Act of 2003, provides that the
Secretary will establish a process (i.e., enrollment and claims
payment) for eligible providers to request payment. The Secretary must
directly pay hospitals, physicians and ambulance providers (including
Indian Health Service, Indian Tribe and Tribal organizations) for their
otherwise un-reimbursed costs of providing services required by section
1867 of the Social Security Act (EMTALA) and related hospital
inpatient, outpatient and ambulance services. CMS will use the
application information to administer this health services program and
establish an audit process. The Federal Reimbursement of Emergency
Health Services Furnished to Undocumented Aliens (Sections 1011)
Provider Enrollment Application has been revised. For a list of these
revisions, refer to the summary of changes document.
Form Number: CMS-10115 (OMB 0938-0929); Frequency: On
occasion; Affected Public: Private sector--Business or other for-profit
and Not-for-profit institutions; Number of Respondents: 5,000; Total
Annual Responses: 5,000; Total Annual Hours: 2,999.
3. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Medicare
Demonstration Ambulatory Care Quality Measure Performance Assessment
Tool (``PAT''); Use: This request is to cover a modification of an
existing, approved data collection effort with a new secure Web based
system. This system will also provide a platform for developing tools
to collect clinical quality data for future demonstrations and
programs. There is no increase in burden. In fact, because all of the
practices submitting data will have Electronic Health Records (EHRs),
it is likely that the originally estimated burden will decrease over
the coming years of the demonstration. CMS is requesting an extension
of the currently approved tool for the collection of ambulatory care
clinical performance measure data.
The data will be used to continue implementation of two
Congressionally mandated demonstration projects (the Physician Group
Practice (PGP) Demonstration and the Medicare Care Management
Performance (MCMP) Demonstration); also the support data collection
under the new EHR Demonstration. Each of these demonstrations, test new
payment methods for improving the quality and efficiency of health care
services delivered to Medicare fee-for-service beneficiaries,
especially those with chronic conditions that account for a
disproportionate share of Medicare expenditures. In addition, the MCMP
and EHR demonstration specifically encourage the adoption of electronic
health records systems as a vehicle for improving how health care is
delivered.
4. Type of Information Collection Request: Extension without
change; Title of Information Collection: Medicare Advantage and
Prescription Drug Program: Final Marketing Provisions CFR 422.111(a)(3)
and 423.128 (a)(3). Use: Medicare Advantage (MA) plans must provide
notice to plan members of impending changes to plan benefits, premiums
and copays in the coming year so that members will be in the best
position to make an informed choice on continued enrollment or
disenrollment from that plan at least 15 days before the Annual
Election Period (AEP). Beginning 2009, organizations will be required
to notify plan members of the coming year changes using a combined
standardized document at the time of enrollment and annually
thereafter.
Section 422.111 requires, to the extent that a MA plan has a Web
site, annual notification through the Web site of written, hard copy
notification sent to the beneficiaries. Section 423.128 requires that a
part D plan have mechanisms for providing specific information on a
timely basis to current and prospective enrollees upon request.
These mechanisms include, Internet Web site that includes
information on part D plan description. MA organizations (formerly M+C
organizations) and Prescription Drug Plan Sponsors use the information
to comply with the eligibility requirements and the MA and part D
contract requirements. CMS will use this information to ensure that
correct information is disclosed to Medicare beneficiaries, both
potential enrollees and enrollees. Form Number: CMS-10260
(OMB: 0938-1051); Frequency: Reporting--Yearly; Affected
Public: Business or other for-profits; Number of Respondents: 790;
Total Annual Responses: 790; Total Annual Hours: 9,480. (For policy
questions regarding this collection contact Camille Brown at 410-786-
0274. For all other issues call 410-786-1326.)
5. Type of Information Collection Request: Reinstatement of
previously approved collection; Title of Information Collection: Health
Care Reform Insurance Web Portal Requirements 45 CFR part 159; Use: In
compliance with the requirement of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Center for Consumer Information
and Insurance Oversight, Centers for Medicare and Medicaid Services,
Department of Health and Human Services, is publishing the following
summary of a proposed information collection request 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.
This information collection is mandated by Sections 1103 and 10102
of The Patient Protection and Affordability Care Act, Public Law 111-
148 (ACA). Once all of the information is collected from insurance
issuers of major medical health insurance (hereon referred to as
issuers) and other affected parties, it will be processed for will
display at https://www.healthcare.gov with quarterly refreshes. The
information that is provided will help the general public make educated
decisions about organizations providing private health care insurance.
In accordance with the provisions of the ACA referenced above, the
U.S. Department of Health and Human Services created a Web site called
healthcare.gov to meet these and other provisions of the law, and data
collection was conducted for six months based upon an emergency
information collection request. The interim final rule published on May
5, 2010 served as the emergency Federal Register Notice for the prior
Information Collection Request (ICR). The Office of Management and
Budget (OMB) reviewed this ICR under emergency processing and approved
the ICR on April 30, 2010. The CCIIO will be submitting a new ICR to
OMB for review and approval in accordance with the Paperwork Reduction
Act of 1995. The proposed information collection is published to obtain
comments from the public and affected agencies.
CCIIO is currently updating a system (hereon referred to as Web
portal) where State Departments of Insurance and issuers will log in to
using a custom user ID and password validation. The
[[Page 13417]]
States will be tasked to provide information on issuers in their State
and various Web sites maintained for consumers. The issuers will be
tasked to provide information on their major medical insurance products
and plans. They will ultimately be given the choice to download a basic
information template to enter data then upload into the Web portal; to
manually enter data within the Web portal itself; or to submit xml
files containing their information. Once the States and issuers submit
their data, they will receive an e-mail notifying them of any errors,
and that their submission was received.
CCIIO is mandating the issuers verify and update their information
on a quarterly basis and is requesting the States to verify State
submitted information on an annual basis. In the event that an issuer
enhances its existing plans, proposes new plans, or deactivates plans,
the organization would be required to update the information in the Web
portal. Changes occurring during the three month quarterly periods will
be allowed utilizing effective dates for both the plans and rates
associated with the plans. Information that is to be collected from
State high risk pools will be collected from The National Association
of State Comprehensive Health Insurance Plans (NASCHIP) at this time.
Updates to this information may be submitted voluntarily.
The estimated hour burden on issuers for the Plan Finder data
collection in the first year is estimated as 84,600 total burden hours,
or 113 hours per organization. This estimate is based on an assumed
average of 450 individual plan issuers and 700 small group plan issuers
per each of the four quarterly collections. It includes 30 hours per
organization for training and communication. Additionally, for each of
the issuers it includes 10 hours of preparation time, one hour of login
and upload time, two hours of troubleshooting and data review and one
half hour for attestation per organization per quarterly refresh.
The estimated hour burden on the States is informed by the fact
that they have already submitted the data once and only need to update.
The overall hours estimate is 575, or 11.5 per Department of Insurance.
This is premised on 2 hours of training and communication, 8 hours for
data collection, and one half hour of submission. Form Number: CMS-
10320 (OMB: 0938-1086); Frequency: Reporting--Annually/
Quarterly; Affected Public: Business or other for-profits and States;
Number of Respondents: 801; Total Annual Responses: 3,051; Total Annual
Hours: 85,175. (For policy questions regarding this collection contact
Beth Liu at 301-492-4268. For all other issues call 410-786-1326.)
6. Type of Information Collection Request: New collection; Title of
Information Collection: Version 5010/ICD-10 Industry Readiness
Assessment Use: The Health Insurance Portability and Accountability Act
of 1996 (HIPAA) requires the Secretary of HHS to adopt transaction
standards that covered entities are required to use when electronically
conducting certain health care administrative transactions, such as
claims, remittance, eligibility and claims status requests and
responses. Accordingly, on January 16, 2009, HHS published final rules
adopting by regulation two sets of standards for HIPAA transactions:
Version 5010 standards for eight types of electronic health care
transactions (claims, eligibility inquiries, remittance advices, etc.)
and ICD-10 code set standards. The final rules set compliance dates of
January 1, 2012 for Version 5010 standards and October 1, 2013 for ICD-
10 standards. HIPAA transactions not meeting the standards by those
dates will be rejected. The final rules also outlined interim
milestones that organizations should meet in order to achieve
compliance by the required dates. For Version 5010, these interim
milestones include completing internal testing and being able to send
and receive compliant transactions by December 2010, commencing
external testing with trading partners by January 2011, and completing
that testing and moving into production by the compliance date of
January 1, 2012. Entities cannot implement ICD-10 standards until they
are in compliance with Version 5010; the interim milestone for ICD-10
is to begin compliance activities (gap analysis, design, development,
internal testing) by January 2011.
CMS has developed an education and communication campaign to
support the adoption of and transition to Version 5010 and ICD-10. The
education and communication activities will be targeted towards the
millions of professionals across the health care industry who must take
steps to prepare for the implementation of the new codes and
transaction standards. CMS is requesting Office of Management and
Budget (OMB) approval to conduct survey research to monitor the health
care industry's awareness of, and preparation for, the transition to
Version 5010 and ICD-10. The aggregated data obtained through the
survey will help inform CMS outreach and education efforts to help
affected entities (health care providers, health plans, clearinghouses,
and then vendors who service them) meet interim milestones and achieve
timely compliance so that they can continue to process HIPAA
transactions without interruption.
CMS has contracted to conduct a tracking survey of populations
charged with implementing Version 5010 and ICD-10 electronic
transaction processing, specifically payers (health insurance plans and
managed care organizations), providers (hospitals and primary care
providers), and vendors (software providers, third-party billers and
clearinghouses). A self-administered Web-based survey will be the data
collection. The data collection field period is expected to be four
weeks in Summer 2011. Form Number: CMS-10381 (OMB: 0938-NEW);
Frequency: Once; Affected Public: Business or other for-profits and
Not-for-profit institutions; Number of Respondents: 600; Total Annual
Responses: 600; Total Annual Hours: 150. (For policy questions
regarding this collection contact Rosali Topper at 410-786-7260. For
all other issues call 410-786-1326.)
7. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Medicare Durable
Medical Equipment Supplier Enrollment Application Use: The primary
function of the CMS 855S DMEPOS supplier enrollment application is to
gather information from a supplier that tells us who it is, whether it
meets certain qualifications to be a health care supplier, where it
renders its services or supplies, the identity of the owners of the
enrolling entity, and information necessary to establish the correct
claims payment. The goal of evaluating and revising the CMS 855S DMEPOS
supplier enrollment application is to simplify and clarify the
information collection without jeopardizing our need to collect
specific information. Additionally, periodic revisions are necessary to
incorporate new regulatory requirements. The goal of this revision of
the CMS 855S is to incorporate new regulatory provisions found at 42
CFR 424.57(c) (1 through 30) and 42 CFR 424.58. These revisions will
allow CMS to be in compliance with the above stated regulations
implementing new quality standards for DMEPOS suppliers, including
accreditation requirements. This revision will also incorporate new
supplier standard regulations found in the final regulation that
published on August 27, 2010 (75 FR 52629-52649). Form Number: CMS-
855(S) (OMB: 0938-1056); Frequency:
[[Page 13418]]
Yearly; Affected Public: Private Sector; Business or other for-profit
and not-for-profit institutions; Number of Respondents: 140,290; Total
Annual Responses: 140,290; Total Annual Hours: (For policy questions
regarding this collection contact Kim McPhillips at 410-786-5374. For
all other issues call 410-786-1326.)
8. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Medicare
Enrollment Application Use: The primary function of the CMS-855
Medicare enrollment application is to gather information from a
provider or supplier that tells us who it is, whether it meets certain
qualifications to be a health care provider or supplier, where it
practices or renders its services, the identity of the owners of the
enrolling entity, and other information necessary to establish correct
claims payments. The goal of this submission is to address the
following issues. The CMS-855A enrollment form currently captures
ownership/managerial information on providers. The data required under
sections 6401 and 6001, however, is more specific than that currently
obtained on the CMS-855A. CMS will therefore create four attachments to
the CMS-855A--two for SNFs and the other two for physician-owned
hospitals--to secure this information. In addition to the application
changes triggered by ACA, CMS is making other revisions to the forms as
well. Form Number: CMS-855 (A, B, I, R) (OMB: 0938-0685);
Frequency: Yearly; Affected Public: Private Sector; Business or other
for-profit and not-for-profit institutions; Number of Respondents:
440,450; Total Annual Responses: 440,450; Total Annual Hours: 842,810
(For policy questions regarding this collection contact Kim McPhillips
at 410-786-5374. For all other issues call 410-786-1326.)
9. Type of Information Collection Request: New collection; Title of
Information Collection: Medicare Enrollment Application for Eligible
Ordering and Referring Physicians and Non-physician Practices Use: CMS
is adding a new CMS-855 Medicare Enrollment Application (CMS 855O--
Medicare Enrollment Application for Ordering and Referring Physicians
only). CMS has found that many providers and suppliers who are not
enrolled in Medicare are ordering and referring physicians for Medicare
enrolled providers and suppliers. The ordering and referring data field
on the CMS 1500 claims submission form requires an ordering or
referring physician to have a Medicare identification number. Without
an ordering or referring physician, specific types of claims submitted
by Medicare approved providers and suppliers are rejected by Medicare
Administrative Contractors (MAC) as required by Medicare regulation.
Therefore, if an ordering or referring physician does not participate
in the Medicare program, but orders or refers his/her patients to a
Medicare provider or supplier, the claim submitted by the Medicare
provider or supplier for the given ordered or referred service is
automatically rejected by the MAC. The CMS 855O allows a physician to
receive a Medicare identification number (without being approved for
billing privileges) for the sole purpose of ordering and referring
beneficiaries to Medicare approved providers and suppliers. This new
Medicare application form allows physicians who do not provide services
to Medicare beneficiaries to be given a Medicare identification number
without having to supply all the data required for the submission of
Medicare claims. It also allows the Medicare program to identify
ordering and referring physicians without having to validate the amount
of data necessary to determine claims payment eligibility (such as
banking information), while continuing to identify the physician's
credentials as valid for ordering and referring purposes. Form Number:
CMS-855(O) (OMB: 0938-NEW0685); Frequency: Yearly; Affected
Public: Private Sector; Business or other for-profit and not-for-profit
institutions; Number of Respondents: 48,000; Total Annual Responses:
48,000; Total Annual Hours: 46,000 (For policy questions regarding this
collection contact Kim McPhillips at 410-786-5374. 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 at https://www.cms.hhs.gov/PaperworkReductionActof1995, or e-
mail your request, including your address, phone number, OMB number,
and CMS document identifier, to Paperwork@cms.hhs.gov, or call the
Reports Clearance Office at 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 May 10, 2011:
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: March 4, 2011.
Martique Jones,
Director, Regulations Development Group, Division B, Office of
Strategic Operations and Regulatory Affairs.
[FR Doc. 2011-5684 Filed 3-10-11; 8:45 am]
BILLING CODE 4120-01-P