Agency Information Collection Activities: Submission for OMB Review; Comment Request, 36518-36521 [2014-15073]
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Federal Register / Vol. 79, No. 124 / Friday, June 27, 2014 / Notices
Health Insurance Portability and
Accountability Act (HIPAA) prohibits
Medicare (a HIPAA covered entity) from
disclosing an individual’s protected
health information without a valid
authorization. In order to be valid, an
authorization must include specified
core elements and statements. Medicare
will make available to Medicare
beneficiaries a standard, valid
authorization to enable beneficiaries to
request the disclosure of their protected
health information. This standard
authorization will simplify the process
of requesting information disclosure for
beneficiaries and minimize the response
time for Medicare. Form CMS–10106,
the Medicare Authorization to Disclose
Personal Health Information, will be
used by Medicare beneficiaries to
authorize Medicare to disclose their
protected health information to a third
party. Form Number: CMS–10106 (OMB
control number: 0938–0930); Frequency:
Occasionally; Affected Public:
Individuals or Households; Number of
Respondents: 1,298,329; Total Annual
Responses: 1,298,329; Total Annual
Hours: 324,582. (For policy questions
regarding this collection contact Sam
Jenkins at 410–786–3261.)
5. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Data Use
Agreement (DUA) for Data Acquired
from the Centers for Medicare &
Medicaid Services (CMS); Use: The
Privacy Act of 1974 allows for
discretionary releases of data
maintained in Privacy Act protected
systems of records under § 552a(b)
(Conditions of Disclosure). The mandate
to account for disclosures of data under
the Privacy Act is found at
§ 552a(c)(Accounting of Certain
Disclosures). This section states that
certain information must be maintained
regarding disclosures made by each
agency. This information is: Date,
Nature, Purpose, and Name/Address of
Recipient. Section 552a(e) sets the
overall requirements that each agency
must meet in order to maintain records
under the Privacy Act. The Data Use
Agreement (DUA) form is needed as part
of the review of each CMS data request
to ensure compliance with the
requirements of the Privacy Act for
disclosures that contain personally
identifiable information (PII). The DUA
form also provides data requestors and
custodians with a formal means to agree
to the data protection and destruction
statutory and regulatory requirements of
CMS’ PII data. The Health Insurance
Portability and Accountability Act
(HIPAA) of 1996, § 1173(d) (Security
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Standards for Health Information)
requires us to protect PII. Additionally,
the Federal Information Security
Management Act (FISMA) of 2002,
§ 3544 (b) (Federal Agency
Responsibilities—Agency Program) also
requires us to develop policies and
procedures for the protection and
destruction of sensitive data to include
PII. We use the information collected by
the DUA to track disclosures, conditions
for disclosure, accounting of disclosures
and agency requirements dictated by the
Privacy Act, HIPAA and FISMA.
Form Number: CMS–R–235 (OMB
control number: 0938–0734); Frequency:
Annually; Affected Public: Private
sector—business or other for-profits and
not-for-profit institutions; Number of
Respondents: 9,220; Total Annual
Responses: 9,220; Total Annual Hours:
2,740. (For policy questions regarding
this collection contact Sharon Kavanagh
at 410–786–5441.)
Dated: June 24, 2014.
Martique Jones,
Deputy Director, Regulations Development
Group, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2014–15075 Filed 6–26–14; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–370 and CMS–
377, CMS 437, CMS–10510, CMS–216–94,
CMS–10494, CMS–10224, CMS–10472 and
CMS–10499]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
ACTION:
Notice.
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995
(PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, and to allow
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the 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
SUMMARY:
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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.
DATES: Comments on the collection(s) of
information must be received by the
OMB desk officer by July 28, 2014.
ADDRESSES: When commenting on the
proposed information collections,
please reference the document identifier
or OMB control number. To be assured
consideration, comments and
recommendations must be received by
the OMB desk officer via one of the
following transmissions: OMB, Office of
Information and Regulatory Affairs,
Attention: CMS Desk Officer, Fax
Number: (202) 395–5806 or, Email:
OIRA_submission@omb.eop.gov. To
obtain copies of a supporting statement
and any related forms for the proposed
collection(s) summarized in this notice,
you may make your request using one
of following:
1. Access CMS’ Web site address at
https://www.cms.hhs.gov/
PaperworkReductionActof1995.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
Reports Clearance Office at (410) 786–
1326.
Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. The term ‘‘collection of
information’’ is defined in 44 U.S.C.
3502(3) and 5 CFR 1320.3(c) and
includes agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires federal agencies
to publish a 30-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension or
reinstatement of an existing collection
of information, before submitting the
collection to OMB for approval. To
comply with this requirement, CMS is
publishing this notice that summarizes
the following proposed collection(s) of
information for public comment:
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 79, No. 124 / Friday, June 27, 2014 / Notices
1. Type of Information Collection
Request: Revision of a currently
approved collection; Titles of
Information Collection: Health
Insurance Benefits Agreement and
Ambulatory Surgical Request for
Certification or Update of Certification
Information in the Medicare Program;
Use: The CMS–370 is used to establish
eligibility for payment. This agreement,
upon submission by the ambulatory
surgical center (ASC) and acceptance for
filing by the Secretary of Health &
Human Services, shall be binding on
both the ASC and the Secretary. The
agreement may be terminated by either
party in accordance with regulations. In
the event of termination, payment will
not be available for ASC services
furnished on or after the effective date
of termination. The CMS–377 is used to
collect facility-specific characteristics
that facilitate CMS’ oversight of
ambulatory surgical centers. The CMS–
377 is submitted by ASCs when they
request initial certification of
compliance with the ASC conditions for
coverage or to update an ASC’s existing
certification information. It is also used
by State agencies who conduct
certification surveys on CMS’ behalf to
maintain information on the facility’s
characteristics that facilitate conducting
surveys, e.g., determining the size and
the composition of the survey team on
the basis of the number of operating and
procedure rooms and the types of
surgical procedures performed in the
ASC.
Form Numbers: CMS–370 and CMS–
377 (OMB control number: 0938–0266);
Frequency: Occasionally; Affected
Public: Private Sector—Business or
other for-profit and Not-for-profit
institutions; Number of Respondents:
5,449; Total Annual Responses: 1,833;
Total Annual Hours: 633. (For policy
questions regarding this collection
contact Erin McCoy at 410–786–2337.)
2. Type of Information Collection
Request: Reinstatement with Change of
a currently approved collection; Title of
Information Collection: Psychiatric Unit
Criteria Work Sheet and Supporting
Regulations; Use: Certain hospital units
are excluded from the Medicare
Prospective Payment System (PPS). The
exclusion of units is not optional on the
part of the provider but is required by
section 1886(d)(1)(B) of the Social
Security Act. That section excludes
psychiatric hospitals, rehabilitation
hospitals, hospitals whose inpatients are
predominantly individuals under 18
years of age (children’s hospitals), and
psychiatric and rehabilitation units
which are a distinct part of a hospital.
We propose to continue the current
process of performing initial
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verifications and annual re-verifications
to determine that psychiatric units
continue to comply with the regulatory
criteria at 42 CFR 412.25 and 42 CFR
412.27 of the PPS regulations. These
regulations state the criteria that distinct
part units must meet for exclusion.
If, as a result of the regular survey
process a hospital is certified as a
psychiatric hospital by the State survey
agency (SA), then it automatically
satisfies the regulatory criteria for
exclusion. Thus, no additional
verification is required for psychiatric
hospitals. Some verification is needed,
however, to ensure that other types of
hospitals and units meet the criteria for
exclusion. Consequently, we instructed
the Medicare Administrative
Contractors (MACs) (formerly known as
FIs) and SAs to perform certain
verification activities, beginning in
October 1983 when PPS was
implemented. We originally developed
the CMS–437 as an SA Worksheet for
verifying exclusions from PPS for
psychiatric units.
Since April 9, 1994, PPS-excluded
psychiatric units already excluded from
the PPS have met our annual
requirement for PPS-exclusion by selfattesting that they remain in compliance
with the PPS exclusion criteria. Under
the current procedure, all psychiatric
units applying for first-time exclusion
are surveyed by the SAs. The SAs also
perform surveys to investigate
complaint allegations and conduct
annual sample re-verification surveys
on 5 percent of all psychiatric units. The
aforementioned exclusions continue to
exist and thus we propose to continue
to use the Criteria Worksheet, Forms
CMS–437, for verifying first-time
exclusions from the PPS, for complaint
surveys, for its annual 5 percent
validation sample, and for facility selfattestation. These forms are related to
the survey and certification and
Medicare approval of the PPS-excluded
units.
Form Number: CMS–437 (OMB
control number: 0938–0358); Frequency:
Annually; Affected Public: Private
sector—Business or other for-profits;
Number of Respondents: 1,614; Total
Annual Responses: 1,614; Total Annual
Hours: 404. (For policy questions
regarding this collection contact Donald
Howard at 410–786–6764.)
3. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Basic Health
Program Report for Health Insurance
Exchange Premium; Use: The Basic
Health Program (BHP) is federally
funded by determining the amount of
payments that the federal government
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would have made through the premium
tax credit (PTC) and cost sharing
reductions (CSR) for people enrolled in
BHP had they instead been enrolled in
an Exchange. To calculate the amounts
for each state, we need the reference
premiums for the second lowest cost
silver plans (SLCSP) in each geographic
area in a state, as SLCSPs are a basic
unit in the calculation of PTC and CSRs
under the Exchanges. To estimate what
PTC and CSRs would have been paid,
the reference premiums for these
SLCSPs are critical components in the
BHP payment methodology. Similarly,
we also need to collect reference
premiums for the lowest cost bronze
plans to appropriately account for CSR
calculations for American Indians and
Alaskan Natives. Reference premiums
are foundational inputs into the BHP
payment methodology. We have the
necessary information to determine
these reference premiums for states with
Exchanges operated by the Federally
Facilitated Exchange (FFE) or are
operated in partnership with the FFE.
Consequently, this collection only
pertains to the 17 states that are
operating State Based Exchanges.
Form Number: CMS–10510 (OMB
control number: 0938–1218); Frequency:
Yearly; Affected Public: State, Local, or
Tribal Governments; Number of
Respondents: 17; Total Annual
Responses: 17; Total Annual Hours: 68.
(For policy questions regarding this
collection contact Carey Appold at 410–
786–2117).
4. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Organ
Procurement Organization/
Histocompatibility Laboratory Cost
Report; Use: We are requesting an
extension of the Form CMS 216–94,
Organ Procurement Organization (OPO)/
Histocompatibility Laboratory Cost
Report. These cost reports are filed
annually by freestanding OPO and
Histocompatibility Lab providers
participating in the Medicare program to
determine the reasonable costs incurred
to furnish treatment for renal transplant
patients. Form Number: CMS–216–94
(OMB control number: 0938–0102);
Frequency: Annually; Affected Public:
Private sector—Business or other forprofits; Number of Respondents: 107;
Total Annual Responses: 107 Total
Annual Hours: 4,815. (For policy
questions regarding this collection
contact Angela Havrilla at 410–786–
4516.)
5. Type of Information Collection
Request: Revision of a previously
approved information collection; Title
of Information Collection: Consumer
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Federal Register / Vol. 79, No. 124 / Friday, June 27, 2014 / Notices
Assistance Tools and Programs of an
Exchange and Certified Application
Counselors; Exchange and Insurance
Market Standards for 2015; Use: Section
1321(a)(1) of the Affordable Care Act
directs and authorizes the Secretary to
issue regulations setting standards for
meeting the requirements under title I of
the Affordable Care Act, with respect to,
among other things, the establishment
and operation of Exchanges. Pursuant to
this authority, regulations establishing
the certified application counselor
program are being finalized at 45 CFR
155.225. Specifically, 45 CFR 155.225(a)
requires an Exchange to establish a
certified application counselor program
that complies with the requirements of
the rule. Section 155.225(b)(1) allows
each Exchange to designate certain
organizations, including organizations
designated by state Medicaid or CHIP
agencies, which will certify their staff
and volunteers to act as certified
application counselors. In accordance
with 45 CFR 155.225(b)(2), Exchanges
may choose to certify directly
individuals who seek to act as certified
application counselors, designate
certain organizations which will certify
staff or volunteers to perform
application services, or do both. In
accordance with 155.225(d)(7), certified
application counselors in all Exchanges
are required to be recertified on at least
an annual basis and successfully
complete Exchange-required
recertification training.
Form Number: CMS–10494 (OMB
control number: 0938–1205); Frequency:
On Occasion; Affected Public: State,
Local, or Tribal Governments, Private
Sector: not-for-profit institutions;
individuals or households; Number of
Respondents: 35,000; Number of
Responses: 160,000; Total Annual
Hours: 19,610. (For policy questions
regarding this collection, contact Tricia
Beckmann at 301–492–4328.)
6. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Healthcare
Common Procedure Coding System
(HCPCS)—Level II Code Modification
Request Process; Use: Each year in the
United States healthcare insurers
process over 5 billion claims for
payment. For Medicare and other health
insurance programs to ensure that these
claims are processed in an orderly and
consistent manner, standardized coding
systems are essential. The Healthcare
Common Procedure Coding System
(HCPCS) Level II Code Set is one of the
standard code sets used for this
purpose. Level II of the HCPCS, also
referred to as alpha-numeric codes, is a
standardized coding system that is used
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primarily to identify products, supplies,
and services not included in the CPT
codes, such as ambulatory services and
durable medical equipment, prosthetics,
orthotics, and supplies (DMEPOS) when
used in the home or outpatient setting.
The HCPCS codeset has been
maintained and distributed via
modifications of codes, modifiers and
descriptions, as a direct result of data
received from applicants. The HCPCS
codeset maintenance is an ongoing
process, as changes are implemented
and updated annually; therefore, the
process requires continual collection of
information from applicants on an
annual basis. As new technology
evolves and new devices, drugs and
supplies are introduced to the market,
applicants submit applications to us
requesting modifications to the HCPCS
Level II codeset.
Form Number: CMS–10224 (OMB
control number: 0938–1042); Frequency:
Annually; Affected Public: Private
sector—Business or other for-profits and
Not-for-profit institutions; Number of
Respondents: 300; Total Annual
Responses: 300 Total Annual Hours:
3,300. (For policy questions regarding
this collection contact Kimberlee Combs
Miller at 410–786–6707.)
7. Type of Information Collection
Request: Revision of a previously
approved information collection; Title
of Information Collection: Exchange
Functions: Standards for Navigators and
Non-Navigator Assistance Personnel;
Use: Section 1321(a)(1) of the Affordable
Care Act directs and authorizes the
Secretary to issue regulations setting
standards for meeting the requirements
under title I of the Affordable Care Act,
with respect to, among other things, the
establishment and operation of
Exchanges. Pursuant to this authority,
regulations have been finalized at 45
CFR 155.210(e)(6) and 45 CFR
155.215(g) to require Navigators, as well
as those non-Navigator personnel to
whom 45 CFR 155.215 applies, to
inform consumers of the functions and
responsibilities of Navigators and nonNavigator assistance personnel (as
applicable) and obtain authorization for
the disclosure of consumer information
to the Navigator or non-Navigator
assistance personnel prior to obtaining
the consumer’s personally identifiable
information. Navigators and nonNavigator assistance personnel to whom
45 CFR 155.215 applies are also
required to maintain a record of the
authorization provided in a form and
manner as determined by the Exchange.
Form Number: CMS–10472 (OMB
control number. 0938–1220); Frequency:
On Occasion; Affected Public: State,
Local, or Tribal Governments, Private
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Sector (not-for-profit institutions);
individuals or households; Number of
Respondents: 5,610; Number of
Responses: 5,610; Total Annual Hours:
35,709. (For policy questions regarding
this collection, contact Emily Ames at
301–492–4246.)
8. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: Public Health
Agency/Registry Readiness to Support
Meaningful Use; Use: The Medicare and
Medicaid Electronic Health Record
(EHR) Incentive Programs provide
incentives for the meaningful use of
Certified Electronic Health Record
Technology (CEHRT). We defined
meaningful use as a set of objectives and
measures in either Stage 1 or Stage 2
depending on how long an eligible
provider has participated in the
program. Both Stage 1 (3 objectives) and
Stage 2 (5 objectives) of meaningful use
contain objectives and measures that
require eligible providers to determine
the readiness of public health agencies
and registries to receive electronic data
from CEHRT. Public comments on the
notice of proposed rulemaking for Stage
2 of meaningful use (77 FR 13697)
asserted that the burden for each
individual eligible provider to
determine the readiness of multiple
public health agencies and registries
could be nearly eliminated if we were
to maintain a database on the readiness
of public health agencies and registries.
In the final rule for Stage 2 of
meaningful use (77 FR 53967), we
agreed that the burden on eligible
providers, public health agencies and
registries would be greatly reduced and
established that we would create such a
database and it would serve as the
definitive information source for
determining public health agency and
registry readiness to receive electronic
data associated with the public health
meaningful use objectives. The
information will be made publicly
available on the CMS Web site
(www.cms.gov/EHRincentiveprograms)
in order to provide a centralized
repository of this information to eligible
providers and eliminate there multiple
individual inquiries to multiple public
health agencies and registries. Form
Number: CMS–10499 (OMB control
number: 0938–New); Frequency: Yearly;
Affected Public: Private sector—
Business or other for-profits and Notfor-profit institutions; Number of
Respondents: 250; Total Annual
Responses: 250; Total Annual Hours:
83. (For policy questions regarding this
collection contact Kathleen Connors de
Laguna at 410–786–2256.
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Federal Register / Vol. 79, No. 124 / Friday, June 27, 2014 / Notices
Dated: June 24, 2014.
Martique Jones,
Deputy Director, Regulations Development
Group, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2014–15073 Filed 6–26–14; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3301–PN]
Medicare and Medicaid Programs;
Application From Det Norske Veritas
Healthcare for Continued CMSApproval of Its Critical Access Hospital
Accreditation Program
Centers for Medicare and
Medicaid Services, HHS.
ACTION: Proposed notice.
AGENCY:
This proposed notice
acknowledges the receipt of an
application from Det Norske Veritas
Healthcare (DNVHC) for continued
recognition as a national accrediting
organization for critical access hospitals
(CAHs) that wish to participate in the
Medicare or Medicaid programs.
DATES: To be assured consideration,
comments must be received at one of
the addresses provided below, no later
than 5 p.m. on July 28, 2014.
ADDRESSES: In commenting, please refer
to file code CMS–3301–PN. Because of
staff and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
You may submit comments in one of
four ways:
1. Electronically. You may submit
electronic comments on specific issues
in this regulation to https://
www.regulations.gov . Follow the
‘‘submit a comment’’ instructions.
2. By regular mail. You may mail
written comments (one original and two
copies) to the following address ONLY:
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, Attention: CMS–3301–
PN, P.O. Box 8016, Baltimore, MD
21244–8016.
Please allow sufficient time for mailed
comments to be received before the
close of the comment period.
3. By express or overnight mail. You
may send written comments to the
following address ONLY: Centers for
Medicare & Medicaid Services,
Department of Health and Human
Services, Attention: CMS–3301–PN,
Mail Stop C4–26–05, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
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SUMMARY:
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4. By hand or courier. Alternatively,
you may deliver (by hand or courier)
your written comments to the following
addresses:
a. For delivery in Washington, DC—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, Room 445–G, Hubert
H. Humphrey Building, 200
Independence Avenue SW.,
Washington, DC 20201.
(Because access to the interior of the
Hubert H. Humphrey Building is not
readily available to persons without
federal government identification,
commenters are encouraged to leave
their comments in the CMS drop slots
located in the main lobby of the
building. A stamp-in clock is available
for persons wishing to retain a proof of
filing by stamping in and retaining an
extra copy of the comments being filed.)
Comments erroneously mailed to the
addresses indicated as appropriate for
hand or courier delivery may be delayed
and received after the comment period.
b. For delivery in Baltimore, MD—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
If you intend to deliver your
comments to the Baltimore address, call
telephone number (410) 786–9994 in
advance to schedule your arrival with
one of our staff members.
For information on viewing public
comments, see the beginning of the
SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Barbara Easterling, (410) 786–0482,
Cindy Melanson, (410) 786–0310,
Patricia Chmielewski, (410) 786–6899,
or Lillian Williams, (410) 786–8636.
SUPPLEMENTARY INFORMATION:
Submitting Comments: We welcome
comments from the public on all issues
set forth in this proposed notice to assist
us in fully considering issues and
developing policies. Referencing the file
code CMS–3301–PN and the specific
‘‘issue identifier’’ that precedes the
section on which you choose to
comment will assist us in fully
considering issues and developing
policies.
Inspection of Public Comments: All
comments received before the close of
the comment period are available for
viewing by the public, including any
personally identifiable or confidential
business information that is included in
a comment. We post all comments
received before the close of the
comment period on the following Web
site as soon as possible after they have
been received: https://
www.regulations.gov. Follow the search
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36521
instructions on that Web site to view
public comments.
Comments received timely will also
be available for public inspection as
they are received, generally beginning
approximately 3 weeks after publication
of a document, at the headquarters of
the Centers for Medicare & Medicaid
Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday
through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an
appointment to view public comments,
phone 1–800–743–3951.
I. Background
Under the Medicare program, eligible
beneficiaries may receive covered
services in a Critical Access Hospital
(CAH) provided certain requirements
are met by the CAH. Section 1820(e) and
1861(mm) of the Social Security Act
(the Act), establishes distinct criteria for
facilities seeking designation as a CAH.
Regulations concerning provider
agreements are at 42 CFR part 489 and
those pertaining to activities relating to
the survey and certification of facilities
are at 42 CFR part 488. The regulations
at 42 CFR part 485, subpart F specify the
conditions that a CAH must meet to
participate in the Medicare program, the
scope of covered services, and the
conditions for Medicare payment for
CAHs.
Generally, to enter into an agreement,
a CAH must first be certified by a state
survey agency as complying with the
conditions or requirements set forth in
part 485, subpart F of our CMS
regulations. Thereafter, the CAH is
subject to regular surveys by a state
survey agency to determine whether it
continues to meet these requirements.
There is an alternative, however, to
surveys by state agencies.
Section 1865(a)(1) of the Act provides
that, if a provider entity demonstrates
through accreditation by an approved
national accrediting organization that all
applicable Medicare conditions are met
or exceeded, we will deem those
provider entities as having met the
requirements. Accreditation by an
accrediting organization is voluntary
and is not required for Medicare
participation.
If an accrediting organization is
recognized by the Secretary as having
standards for accreditation that meet or
exceed Medicare requirements, any
provider entity accredited by the
national accrediting body’s approved
program would be deemed to meet the
Medicare conditions. A national
accrediting organization applying for
approval of its accreditation program
under part 488, subpart A, must provide
us with reasonable assurance that the
E:\FR\FM\27JNN1.SGM
27JNN1
]]>Agencies
[Federal Register Volume 79, Number 124 (Friday, June 27, 2014)]
[Notices]
[Pages 36518-36521]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-15073]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-370 and CMS-377, CMS 437, CMS-10510, CMS-216-
94, CMS-10494, CMS-10224, CMS-10472 and CMS-10499]
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
ACTION: Notice.
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SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is
announcing an opportunity for the public to comment on CMS' intention
to collect information from the public. Under the Paperwork Reduction
Act of 1995 (PRA), federal agencies are required to publish notice in
the Federal Register concerning each proposed collection of
information, including each proposed extension or reinstatement of an
existing collection of information, and to allow a second opportunity
for public comment on the notice. Interested persons are invited to
send comments regarding the 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.
DATES: Comments on the collection(s) of information must be received by
the OMB desk officer by July 28, 2014.
ADDRESSES: When commenting on the proposed information collections,
please reference the document identifier or OMB control number. To be
assured consideration, comments and recommendations must be received by
the OMB desk officer via one of the following transmissions: OMB,
Office of Information and Regulatory Affairs, Attention: CMS Desk
Officer, Fax Number: (202) 395-5806 or, Email: OIRA_submission@omb.eop.gov. To obtain copies of a supporting statement and
any related forms for the proposed collection(s) summarized in this
notice, you may make your request using one of following:
1. Access CMS' Web site address at https://www.cms.hhs.gov/PaperworkReductionActof1995.
2. Email your request, including your address, phone number, OMB
number, and CMS document identifier, to Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at (410) 786-1326.
FOR FURTHER INFORMATION CONTACT: Reports Clearance Office at (410) 786-
1326.
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from
the Office of Management and Budget (OMB) for each collection of
information they conduct or sponsor. The term ``collection of
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and
includes agency requests or requirements that members of the public
submit reports, keep records, or provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires
federal agencies to publish a 30-day notice in the Federal Register
concerning each proposed collection of information, including each
proposed extension or reinstatement of an existing collection of
information, before submitting the collection to OMB for approval. To
comply with this requirement, CMS is publishing this notice that
summarizes the following proposed collection(s) of information for
public comment:
[[Page 36519]]
1. Type of Information Collection Request: Revision of a currently
approved collection; Titles of Information Collection: Health Insurance
Benefits Agreement and Ambulatory Surgical Request for Certification or
Update of Certification Information in the Medicare Program; Use: The
CMS-370 is used to establish eligibility for payment. This agreement,
upon submission by the ambulatory surgical center (ASC) and acceptance
for filing by the Secretary of Health & Human Services, shall be
binding on both the ASC and the Secretary. The agreement may be
terminated by either party in accordance with regulations. In the event
of termination, payment will not be available for ASC services
furnished on or after the effective date of termination. The CMS-377 is
used to collect facility-specific characteristics that facilitate CMS'
oversight of ambulatory surgical centers. The CMS-377 is submitted by
ASCs when they request initial certification of compliance with the ASC
conditions for coverage or to update an ASC's existing certification
information. It is also used by State agencies who conduct
certification surveys on CMS' behalf to maintain information on the
facility's characteristics that facilitate conducting surveys, e.g.,
determining the size and the composition of the survey team on the
basis of the number of operating and procedure rooms and the types of
surgical procedures performed in the ASC.
Form Numbers: CMS-370 and CMS-377 (OMB control number: 0938-0266);
Frequency: Occasionally; Affected Public: Private Sector--Business or
other for-profit and Not-for-profit institutions; Number of
Respondents: 5,449; Total Annual Responses: 1,833; Total Annual Hours:
633. (For policy questions regarding this collection contact Erin McCoy
at 410-786-2337.)
2. Type of Information Collection Request: Reinstatement with
Change of a currently approved collection; Title of Information
Collection: Psychiatric Unit Criteria Work Sheet and Supporting
Regulations; Use: Certain hospital units are excluded from the Medicare
Prospective Payment System (PPS). The exclusion of units is not
optional on the part of the provider but is required by section
1886(d)(1)(B) of the Social Security Act. That section excludes
psychiatric hospitals, rehabilitation hospitals, hospitals whose
inpatients are predominantly individuals under 18 years of age
(children's hospitals), and psychiatric and rehabilitation units which
are a distinct part of a hospital. We propose to continue the current
process of performing initial verifications and annual re-verifications
to determine that psychiatric units continue to comply with the
regulatory criteria at 42 CFR 412.25 and 42 CFR 412.27 of the PPS
regulations. These regulations state the criteria that distinct part
units must meet for exclusion.
If, as a result of the regular survey process a hospital is
certified as a psychiatric hospital by the State survey agency (SA),
then it automatically satisfies the regulatory criteria for exclusion.
Thus, no additional verification is required for psychiatric hospitals.
Some verification is needed, however, to ensure that other types of
hospitals and units meet the criteria for exclusion. Consequently, we
instructed the Medicare Administrative Contractors (MACs) (formerly
known as FIs) and SAs to perform certain verification activities,
beginning in October 1983 when PPS was implemented. We originally
developed the CMS-437 as an SA Worksheet for verifying exclusions from
PPS for psychiatric units.
Since April 9, 1994, PPS-excluded psychiatric units already
excluded from the PPS have met our annual requirement for PPS-exclusion
by self-attesting that they remain in compliance with the PPS exclusion
criteria. Under the current procedure, all psychiatric units applying
for first-time exclusion are surveyed by the SAs. The SAs also perform
surveys to investigate complaint allegations and conduct annual sample
re-verification surveys on 5 percent of all psychiatric units. The
aforementioned exclusions continue to exist and thus we propose to
continue to use the Criteria Worksheet, Forms CMS-437, for verifying
first-time exclusions from the PPS, for complaint surveys, for its
annual 5 percent validation sample, and for facility self-attestation.
These forms are related to the survey and certification and Medicare
approval of the PPS-excluded units.
Form Number: CMS-437 (OMB control number: 0938-0358); Frequency:
Annually; Affected Public: Private sector--Business or other for-
profits; Number of Respondents: 1,614; Total Annual Responses: 1,614;
Total Annual Hours: 404. (For policy questions regarding this
collection contact Donald Howard at 410-786-6764.)
3. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Basic Health
Program Report for Health Insurance Exchange Premium; Use: The Basic
Health Program (BHP) is federally funded by determining the amount of
payments that the federal government would have made through the
premium tax credit (PTC) and cost sharing reductions (CSR) for people
enrolled in BHP had they instead been enrolled in an Exchange. To
calculate the amounts for each state, we need the reference premiums
for the second lowest cost silver plans (SLCSP) in each geographic area
in a state, as SLCSPs are a basic unit in the calculation of PTC and
CSRs under the Exchanges. To estimate what PTC and CSRs would have been
paid, the reference premiums for these SLCSPs are critical components
in the BHP payment methodology. Similarly, we also need to collect
reference premiums for the lowest cost bronze plans to appropriately
account for CSR calculations for American Indians and Alaskan Natives.
Reference premiums are foundational inputs into the BHP payment
methodology. We have the necessary information to determine these
reference premiums for states with Exchanges operated by the Federally
Facilitated Exchange (FFE) or are operated in partnership with the FFE.
Consequently, this collection only pertains to the 17 states that are
operating State Based Exchanges.
Form Number: CMS-10510 (OMB control number: 0938-1218); Frequency:
Yearly; Affected Public: State, Local, or Tribal Governments; Number of
Respondents: 17; Total Annual Responses: 17; Total Annual Hours: 68.
(For policy questions regarding this collection contact Carey Appold at
410-786-2117).
4. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Organ Procurement
Organization/Histocompatibility Laboratory Cost Report; Use: We are
requesting an extension of the Form CMS 216-94, Organ Procurement
Organization (OPO)/Histocompatibility Laboratory Cost Report. These
cost reports are filed annually by freestanding OPO and
Histocompatibility Lab providers participating in the Medicare program
to determine the reasonable costs incurred to furnish treatment for
renal transplant patients. Form Number: CMS-216-94 (OMB control number:
0938-0102); Frequency: Annually; Affected Public: Private sector--
Business or other for-profits; Number of Respondents: 107; Total Annual
Responses: 107 Total Annual Hours: 4,815. (For policy questions
regarding this collection contact Angela Havrilla at 410-786-4516.)
5. Type of Information Collection Request: Revision of a previously
approved information collection; Title of Information Collection:
Consumer
[[Page 36520]]
Assistance Tools and Programs of an Exchange and Certified Application
Counselors; Exchange and Insurance Market Standards for 2015; Use:
Section 1321(a)(1) of the Affordable Care Act directs and authorizes
the Secretary to issue regulations setting standards for meeting the
requirements under title I of the Affordable Care Act, with respect to,
among other things, the establishment and operation of Exchanges.
Pursuant to this authority, regulations establishing the certified
application counselor program are being finalized at 45 CFR 155.225.
Specifically, 45 CFR 155.225(a) requires an Exchange to establish a
certified application counselor program that complies with the
requirements of the rule. Section 155.225(b)(1) allows each Exchange to
designate certain organizations, including organizations designated by
state Medicaid or CHIP agencies, which will certify their staff and
volunteers to act as certified application counselors. In accordance
with 45 CFR 155.225(b)(2), Exchanges may choose to certify directly
individuals who seek to act as certified application counselors,
designate certain organizations which will certify staff or volunteers
to perform application services, or do both. In accordance with
155.225(d)(7), certified application counselors in all Exchanges are
required to be recertified on at least an annual basis and successfully
complete Exchange-required recertification training.
Form Number: CMS-10494 (OMB control number: 0938-1205); Frequency:
On Occasion; Affected Public: State, Local, or Tribal Governments,
Private Sector: not-for-profit institutions; individuals or households;
Number of Respondents: 35,000; Number of Responses: 160,000; Total
Annual Hours: 19,610. (For policy questions regarding this collection,
contact Tricia Beckmann at 301-492-4328.)
6. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Healthcare Common
Procedure Coding System (HCPCS)--Level II Code Modification Request
Process; Use: Each year in the United States healthcare insurers
process over 5 billion claims for payment. For Medicare and other
health insurance programs to ensure that these claims are processed in
an orderly and consistent manner, standardized coding systems are
essential. The Healthcare Common Procedure Coding System (HCPCS) Level
II Code Set is one of the standard code sets used for this purpose.
Level II of the HCPCS, also referred to as alpha-numeric codes, is a
standardized coding system that is used primarily to identify products,
supplies, and services not included in the CPT codes, such as
ambulatory services and durable medical equipment, prosthetics,
orthotics, and supplies (DMEPOS) when used in the home or outpatient
setting.
The HCPCS codeset has been maintained and distributed via
modifications of codes, modifiers and descriptions, as a direct result
of data received from applicants. The HCPCS codeset maintenance is an
ongoing process, as changes are implemented and updated annually;
therefore, the process requires continual collection of information
from applicants on an annual basis. As new technology evolves and new
devices, drugs and supplies are introduced to the market, applicants
submit applications to us requesting modifications to the HCPCS Level
II codeset.
Form Number: CMS-10224 (OMB control number: 0938-1042); Frequency:
Annually; Affected Public: Private sector--Business or other for-
profits and Not-for-profit institutions; Number of Respondents: 300;
Total Annual Responses: 300 Total Annual Hours: 3,300. (For policy
questions regarding this collection contact Kimberlee Combs Miller at
410-786-6707.)
7. Type of Information Collection Request: Revision of a previously
approved information collection; Title of Information Collection:
Exchange Functions: Standards for Navigators and Non-Navigator
Assistance Personnel; Use: Section 1321(a)(1) of the Affordable Care
Act directs and authorizes the Secretary to issue regulations setting
standards for meeting the requirements under title I of the Affordable
Care Act, with respect to, among other things, the establishment and
operation of Exchanges. Pursuant to this authority, regulations have
been finalized at 45 CFR 155.210(e)(6) and 45 CFR 155.215(g) to require
Navigators, as well as those non-Navigator personnel to whom 45 CFR
155.215 applies, to inform consumers of the functions and
responsibilities of Navigators and non-Navigator assistance personnel
(as applicable) and obtain authorization for the disclosure of consumer
information to the Navigator or non-Navigator assistance personnel
prior to obtaining the consumer's personally identifiable information.
Navigators and non-Navigator assistance personnel to whom 45 CFR
155.215 applies are also required to maintain a record of the
authorization provided in a form and manner as determined by the
Exchange.
Form Number: CMS-10472 (OMB control number. 0938-1220); Frequency:
On Occasion; Affected Public: State, Local, or Tribal Governments,
Private Sector (not-for-profit institutions); individuals or
households; Number of Respondents: 5,610; Number of Responses: 5,610;
Total Annual Hours: 35,709. (For policy questions regarding this
collection, contact Emily Ames at 301-492-4246.)
8. Type of Information Collection Request: New collection (Request
for a new OMB control number); Title of Information Collection: Public
Health Agency/Registry Readiness to Support Meaningful Use; Use: The
Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs
provide incentives for the meaningful use of Certified Electronic
Health Record Technology (CEHRT). We defined meaningful use as a set of
objectives and measures in either Stage 1 or Stage 2 depending on how
long an eligible provider has participated in the program. Both Stage 1
(3 objectives) and Stage 2 (5 objectives) of meaningful use contain
objectives and measures that require eligible providers to determine
the readiness of public health agencies and registries to receive
electronic data from CEHRT. Public comments on the notice of proposed
rulemaking for Stage 2 of meaningful use (77 FR 13697) asserted that
the burden for each individual eligible provider to determine the
readiness of multiple public health agencies and registries could be
nearly eliminated if we were to maintain a database on the readiness of
public health agencies and registries. In the final rule for Stage 2 of
meaningful use (77 FR 53967), we agreed that the burden on eligible
providers, public health agencies and registries would be greatly
reduced and established that we would create such a database and it
would serve as the definitive information source for determining public
health agency and registry readiness to receive electronic data
associated with the public health meaningful use objectives. The
information will be made publicly available on the CMS Web site
(www.cms.gov/EHRincentiveprograms) in order to provide a centralized
repository of this information to eligible providers and eliminate
there multiple individual inquiries to multiple public health agencies
and registries. Form Number: CMS-10499 (OMB control number: 0938-New);
Frequency: Yearly; Affected Public: Private sector--Business or other
for-profits and Not-for-profit institutions; Number of Respondents:
250; Total Annual Responses: 250; Total Annual Hours: 83. (For policy
questions regarding this collection contact Kathleen Connors de Laguna
at 410-786-2256.
[[Page 36521]]
Dated: June 24, 2014.
Martique Jones,
Deputy Director, Regulations Development Group, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2014-15073 Filed 6-26-14; 8:45 am]
BILLING CODE 4120-01-P
