Agency Information Collection Activities: Proposed Collection; Comment Request, 30574-30576 [E9-15193]
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30574
Federal Register / Vol. 74, No. 122 / Friday, June 26, 2009 / Notices
Office, Economic Recovery, Fatherhood and
Healthy Families, Inter-religious Dialogue
and Cooperation, Environment and Climate
Change and Global Poverty and
Development.
For Further Information Contact: Mara
Vanderslice, 202–205–2419,
mara.vanderslice@hhs.gov.
Dated: June 22, 2009.
Mara Vanderslice,
Special Assistant.
[FR Doc. E9–15185 Filed 6–25–09; 8:45 am]
BILLING CODE 4154–07–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10237, CMS–
10137, CMS–10285, CMS–R–38, CMS–R–70,
CMS–10287, CMS–10080 and CMS–846–849,
854, 10125, 10126, and 10269]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare &
Medicaid Services.
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: Medicare
Advantage Applications–Part C; Use:
Under section 1851(a)(1) of the Social
Security Act, every individual entitled
to Medicare Part A and enrolled under
Part B, except for most individuals with
end-stage renal disease (ESRD), could
elect to receive benefits either through
the Original Medicare Program or an
M+C plan, if one was offered where he
or she lived. The Medicare Prescription
Drug, Improvement, and Modernization
VerDate Nov<24>2008
16:39 Jun 25, 2009
Jkt 217001
Act of 2003 (MMA) Pub. L. 108–173 was
enacted on December 8, 2003. The
MMA established the Medicare
Prescription Drug Benefit Program (Part
D) and made revisions to the provisions
of Medicare Part C, governing what is
now called the Medicare Advantage
(MA) program (formerly
Medicare+Choice).
Coverage for the prescription drug
benefit is provided through contracted
prescription drug plans or through
Medicare Advantage (MA) plans that
offer integrated prescription drug and
health care coverage (MA–PD plans).
Cost plans that are required under
section 1876 of the Social Security Act,
and Employer Group Waiver Plans
(EGWP) may also provide a Part D
benefit. Organizations wishing to
provide services under the MA and
MA–PD plans must complete an
application, negotiate rates and receive
final approval from CMS. Certain
existing MA plans may also expand
their contracted area by completing the
Service Area Expansion (SAE)
application. Health plans must meet
regulatory requirements to enter into a
contract with CMS in order to provide
health benefits to Medicare
beneficiaries. The revised MA
applications are the collection
receptacles required. Refer to the
supporting document ‘‘High-Level
Summary of All Part C Application
Revisions from 2010 Version of Part C
Application to 2011 Version’’ for a list
of changes: Form Number: CMS–10237
(OMB#: 0938–0935); Frequency:
Reporting—Yearly; Affected Public:
Business or other for-profits and Notfor-profit institutions; Number of
Respondents: 291; Total Annual
Responses: 291; Total Annual Hours:
9,547. (For policy questions regarding
this collection contact Letticia Ramsey
at 410–786–5262. For all other issues
call 410–786–1326.)
2. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Application for
Prescription Drug Plans (PDP);
Application for Medicare Advantage
Prescription Drug (MA–PD);
Application for Cost Plans to Offer
Qualified Prescription Drug Coverage;
Application for Employer Group Waiver
Plans to Offer Prescription Drug
Coverage; Service Area Expansion
Application for Prescription Drug
Coverage; Use: The Medicare
Prescription Drug Benefit program was
established by section 101 of the
Medicare Prescription Drug,
Improvement, and Modernization Act of
2003 (MMA) and is codified in section
1860D of the Social Security Act (the
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
Act). Section 101 of the MMA amended
Title XVIII of the Social Security Act by
redesignating Part D as Part E and
inserting a new Part D, which
establishes the voluntary Prescription
Drug Benefit Program (‘‘Part D’’). The
MMA was amended on July 15, 2008 by
the enactment of the Medicare
Improvements for Patients and
Providers Act of 2008 (MIPPA).
Coverage for the prescription drug
benefit is provided through contracted
prescription drug plans (PDPs) or
through Medicare Advantage (MA)
plans that offer integrated prescription
drug and health care coverage (MA–PD
plans). Cost Plans that are regulated
under Section 1876 of the Social
Security Act, and Employer Group
Waiver Plans (EGWP) may also provide
a Part D benefit. Organizations wishing
to provide services under the
Prescription Drug Benefit Program must
complete an application, negotiate rates
and receive final approval from CMS.
Existing Part D sponsors may also
expand their contracted service area by
completing the Service Area Expansion
(SAE) application. Refer to supporting
document ‘‘Summary of Substantive
and Technical Changes for All Part D
Application Revisions from 2010
Version of Part D application to 2011
Draft Version’’: Form Number: CMS–
10137 (OMB#: 0938–0936); Frequency:
Reporting—Once; Affected Public:
Business or other for-profits and Notfor-profit institutions; Number of
Respondents: 453; Total Annual
Responses: 453; Total Annual Hours:
11,919. (For policy questions regarding
this collection contact Marla Rothouse
at 410–786–8063. For all other issues
call 410–786–1326.)
3. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Request for
Expedited Review of Denial of Premium
Assistance; Use: The American
Recovery and Reinvestment Act of 2009
provides for premium assistance and
expanded eligibility for health benefits
under both the Consolidated Omnibus
Budget Reconciliation Act of 1986,
commonly called COBRA, and
comparable State continuation coverage
programs. This premium assistance is
not paid directly to the covered
employee or the qualified beneficiary,
but instead is in the form of a tax credit
for the health plan, the employer, or the
insurer. ‘‘Assistance eligible
individuals’’ pay only 35% of their
continuation coverage premiums to the
plan and the remaining 65% is paid
through the tax credit.
If an individual requests treatment as
an assistance eligible individual and the
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Federal Register / Vol. 74, No. 122 / Friday, June 26, 2009 / Notices
employee’s group health plan,
employer, or insurer denies him or her
the reduced premium assistance, the
Secretary of Health and Human Services
must provide for expedited review of
the denial upon application to the
Secretary in the form and manner the
Secretary provides. The Secretary is
required to make a determination within
15 business days after receipt of an
individual’s application for review.
The Request for Review If You Have
Been Denied Premium Assistance (the
‘‘application’’) is the form that will be
used by individuals to file their
expedited review appeals. Each
individual must complete all
information requested on the
application in order for CMS to begin
reviewing his or her case. An
application cannot be reviewed if
sufficient information is not provided.
Refer to the supporting document
‘‘Crosswalk of Changes Between Request
for Expedited Review of Denial of
Premium Assistance (4/09) and Request
for Review if You Have Been Denied
Premium Assistance (6/09)’’ for a list of
changes: Form Number: CMS–10285
(OMB#: 0938–1062); Frequency:
Reporting—Once; Affected Public:
Individuals and households; Number of
Respondents: 12,000; Total Annual
Responses: 12,000; Total Annual Hours:
12,000. (For policy questions regarding
this collection contact Jim Mayhew at
410–786–9244. For all other issues call
410–786–1326.)
4. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Conditions of
Certification for Rural Health Clinics
and Supporting Regulations in 42 CFR
491.9, 491.10, 491.11; Use: The Rural
Health Clinic (RHC) conditions of
certification are based on criteria
prescribed in law and are designed to
ensure that each facility has a properly
trained staff to provide appropriate care
and to assure a safe physical
environment for patients. The Centers
for Medicare and Medicaid Services
(CMS) uses these conditions of
participation to certify RHCs wishing to
participate in the Medicare program.
These requirements are similar in intent
to standards developed by industry
organizations such as the Joint
Commission on Accreditation of
Hospitals, and the National League of
Nursing/American Public Association
and merely reflect accepted standards of
management and care to which rural
health clinics must adhere. Form
Number: CMS–R–38 (OMB#: 0938–
0334); Frequency: Recordkeeping and
Reporting—Annually and upon initial
application for Medicare approval;
VerDate Nov<24>2008
16:39 Jun 25, 2009
Jkt 217001
Affected Public: Business or other forprofits; Number of Respondents: 3,937;
Total Annual Responses: 3,937; Total
Annual Hours: 18,932. (For policy
questions regarding this collection
contact Mary Collins at 410–786–3189.
For all other issues call 410–786–1326.)
5. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Information
Collection Requirements in HSQ–110,
Acquisition, Protection and Disclosure
of Peer Review Organization
Information and Supporting Regulations
in 42 CFR, Sections 480.104, 480.105,
480.116, and 480.134; Use: The Peer
Review Improvement Act of 1982
authorizes quality improvement
organizations (QIOs), formally known as
peer review organizations (PROs), to
acquire information necessary to fulfill
their duties and functions and places
limits on disclosure of the information.
The QIOs are required to provide
notices to the affected parties when
disclosing information about them.
These requirements serve to protect the
rights of the affected parties. The
information provided in these notices is
used by the patients, practitioners and
providers to: obtain access to the data
maintained and collected on them by
the QIOs; add additional data or make
changes to existing QIO data; and reflect
in the QIO’s record the reasons for the
QIO’s disagreeing with an individual’s
or provider’s request for amendment.
Form Number: CMS–R–70 (OMB#:
0938–0426); Frequency: Reporting—On
occasion; Affected Public: Business or
other for-profits; Number of
Respondents: 362; Total Annual
Responses: 3729; Total Annual Hours:
60,919. (For policy questions regarding
this collection contact Tom Kessler at
410–786–1991. For all other issues call
410–786–1326.)
6. Type of Information Collection
Request: New collection; Title of
Information Collection: Medicare
Quality of Care Complaint Form; Use: In
accordance with Section 1154(a)(14) of
the Social Security Act, Quality
Improvement Organizations (QIOs) are
required to conduct appropriate reviews
of all written complaints submitted by
beneficiaries concerning the quality of
care received. The Medicare Quality of
Care Complaint Form will be used by
Medicare beneficiaries to submit quality
of care complaints. This form will
establish a standard form for all
beneficiaries to utilize and ensure
pertinent information is obtained by
QIOs to effectively process these
complaints. Form Number: CMS–10287
(OMB#: 0938–New); Frequency:
Reporting—On occasion; Affected
PO 00000
Frm 00076
Fmt 4703
Sfmt 4703
30575
Public: Individuals or Households;
Number of Respondents: 3,500; Total
Annual Responses: 3,500; Total Annual
Hours: 583. (For policy questions
regarding this collection contact Tom
Kessler at 410–786–1991. For all other
issues call 410–786–1326.)
7. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Publication
Usage Survey; Use: The Publication
Usage survey was developed to gather
information from people who request or
access Medicare publications, to ensure
comprehension, usability, and use of the
publications. CMS is seeking
understanding about whether
publications have been effective in
informing members of the Medicare
audience regarding policy and benefits.
Included in the survey are questions
regarding the satisfaction of publication
users with specific publications and
whether the information they received
informed them about the Medicare
program. Information gathered in this
survey will be used only for purposes of
targeting and improving
communications with Medicare
beneficiaries, caregivers, partners, and
community organizations. Form
Number: CMS–10080 (OMB#: 0938–
0892); Frequency: Reporting—On
occasion; Affected Public: Individuals or
Households; Number of Respondents:
3,800; Total Annual Responses: 3,800;
Total Annual Hours: 950. (For policy
questions regarding this collection
contact Renee Clarke at 410–786–0006.
For all other issues call 410–786–1326.)
8. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Durable Medical
Equipment Medicare Administrative
Contractors (MAC), Certificates of
Medical Necessity; Use: The certificate
of medical necessity (CMN) collects
information required to help determine
the medical necessity of certain items.
CMS requires CMNs where there may be
a vulnerability to the Medicare program.
Each initial claim for these items must
have an associated CMN for the
beneficiary. Suppliers (those who bill
for the items) complete the
administrative information (e.g.,
patient’s name and address, items
ordered, etc.) on each CMN. The 1994
Amendments to the Social Security Act
require that the supplier also provide a
narrative description of the items
ordered and all related accessories, their
charge for each of these items, and the
Medicare fee schedule allowance (where
applicable). The supplier then sends the
CMN to the treating physician or other
clinicians (e.g., physician assistant,
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Federal Register / Vol. 74, No. 122 / Friday, June 26, 2009 / Notices
LPN, etc.) who completes questions
pertaining to the beneficiary’s medical
condition and signs the CMN. The
physician or other clinician returns the
CMN to the supplier who has the option
to maintain a copy and then submits the
CMN (paper or electronic) to CMS,
along with a claim for reimbursement.
Due to a technical oversight on the
part of CMS, an important question on
CMN Form 10269 was omitted from the
last OMB submission that would allow
claims with an apnea-hypopnea index
(AHI) or respiratory disturbance index
(RDI) greater than or equal to 5 without
symptoms for Criterion 2 be paid for by
the Medicare program. The omission of
the following question ‘‘Does the patient
have documented evidence of at least
one of the following: Excessive daytime
sleepiness, impaired cognition, mood
disorders, insomnia, hypertension,
ischemic heart disease or history of
stroke’’ could cause improper payment
of claims without regards as to whether
the patient has signs or symptoms in
support of meeting the applicable
coverage criteria for PAP devices. We
are resubmitting this information
collection request to have the revised
CMN Form 10269 approved. None of the
other CMN forms have changed.
Form Number: CMS–846–849, 854,
10125, 10126, 10269 (OMB# 0938–
0679); Frequency: Occasionally;
Affected Public: Business or other forprofit and Not-for-profit institutions;
Number of Respondents: 59,200; Total
Annual Responses: 6,480,000; Total
Annual Hours: 1,296,000. (For policy
questions regarding this collection
contact Doris Jackson at (410) 786–4459.
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 on (410) 786–
1326.
In commenting on the proposed
information collections please reference
the document identifier or OMB control
number. To be assured consideration,
comments and recommendations must
be submitted in one of the following
ways by August 25, 2009:
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.
VerDate Nov<24>2008
16:39 Jun 25, 2009
Jkt 217001
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: June 18, 2009.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E9–15193 Filed 6–25–09; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier CMS–R–205 and CMS–
R–206]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
AGENCY: Centers for Medicare &
Medicaid Services.
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: Extension of a currently
approved collection; Title of
Information Collection: Information
Collection Requirements Referenced in
HIPAA title I for the Individual Market,
Supporting Regulations at 45 CFR 148
(148.120, 148.122, 148.124, 148.126,
and 148.128), Forms and Instructions;
Use: The provisions of title I of the
Health Insurance Portability and
Accountability Act of 1996 (HIPAA)
amend the Public Health Service Act
PO 00000
Frm 00077
Fmt 4703
Sfmt 4703
(PHS Act) and are designed to make it
easier for people to get access to health
care coverage; to reduce the limitations
that can be put on the coverage; and to
make it more difficult for issuers to
terminate the coverage. The information
collection requirements will ensure that
issuers in the individual market comply
with HIPAA title I, provide individuals
with certificates of creditable coverage
necessary to demonstrate prior
creditable coverage and file
documentation with CMS for review in
a Federal direct enforcement state.
Requirements must also ensure states’
flexibility to implement state alternative
mechanisms. Form Number: CMS–R–
205 (OMB#: 0938–0703); Frequency:
Reporting—Yearly and Occasionally;
Affected Public: Business or other Forprofit and Not-for-profit institutions;
Number of Respondents: 2,042; Total
Annual Responses: 2,979,801; Total
Annual Hours: 856,384. (For policy
questions regarding this collection
contact Louis Blank at 410–786–5511.
For all other issues call 410–786–1326.)
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Information
Collection Requirements in HIPAA title
I for the Group Market, Supporting
Regulations 45 CFR 146 (146.111,
146.115, 146.117, 146.150, 146.152,
146.160 and 146.180) Forms and
Instructions; Use: The provisions of title
I of the Health Insurance Portability and
Accountability Act of 1996 (HIPAA) are
designed to make it easier for people to
get access to health care coverage and to
reduce the limitations that can be put on
the coverage. This collection pertains to
notices issued by group health
insurance issuers and self-funded nonFederal governmental plans as required
by 45 CFR 146. These notices are
triggered by the issuance of certificates
of creditable coverage; notification of
preexisting condition exclusions;
notification of special enrollment rights;
and State review of issuers’ filings of
group market products or similar
Federal review in cases in which a State
is not enforcing a HIPAA group market
provision. Form Number: CMS–R–206
(OMB#: 0938–0702); Frequency:
Reporting—Yearly; Affected Public:
Private Sector; Business or other Forprofit and Not-for-profit institutions,
and State, Local, or Tribal Governments;
Number of Respondents: 8,050; Total
Annual Responses: 37,002,217; Total
Annual Hours: 2,920,012. (For policy
questions regarding this collection
contact Louis Blank at 410–786–5511.
For all other issues call 410–786–1326.)
To be assured consideration,
comments and recommendations for the
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Agencies
[Federal Register Volume 74, Number 122 (Friday, June 26, 2009)]
[Notices]
[Pages 30574-30576]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-15193]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10237, CMS-10137, CMS-10285, CMS-R-38, CMS-R-
70, CMS-10287, CMS-10080 and CMS-846-849, 854, 10125, 10126, and 10269]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & Medicaid Services.
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: Medicare
Advantage Applications-Part C; Use: Under section 1851(a)(1) of the
Social Security Act, every individual entitled to Medicare Part A and
enrolled under Part B, except for most individuals with end-stage renal
disease (ESRD), could elect to receive benefits either through the
Original Medicare Program or an M+C plan, if one was offered where he
or she lived. The Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA) Pub. L. 108-173 was enacted on December
8, 2003. The MMA established the Medicare Prescription Drug Benefit
Program (Part D) and made revisions to the provisions of Medicare Part
C, governing what is now called the Medicare Advantage (MA) program
(formerly Medicare+Choice).
Coverage for the prescription drug benefit is provided through
contracted prescription drug plans or through Medicare Advantage (MA)
plans that offer integrated prescription drug and health care coverage
(MA-PD plans). Cost plans that are required under section 1876 of the
Social Security Act, and Employer Group Waiver Plans (EGWP) may also
provide a Part D benefit. Organizations wishing to provide services
under the MA and MA-PD plans must complete an application, negotiate
rates and receive final approval from CMS. Certain existing MA plans
may also expand their contracted area by completing the Service Area
Expansion (SAE) application. Health plans must meet regulatory
requirements to enter into a contract with CMS in order to provide
health benefits to Medicare beneficiaries. The revised MA applications
are the collection receptacles required. Refer to the supporting
document ``High-Level Summary of All Part C Application Revisions from
2010 Version of Part C Application to 2011 Version'' for a list of
changes: Form Number: CMS-10237 (OMB: 0938-0935); Frequency:
Reporting--Yearly; Affected Public: Business or other for-profits and
Not-for-profit institutions; Number of Respondents: 291; Total Annual
Responses: 291; Total Annual Hours: 9,547. (For policy questions
regarding this collection contact Letticia Ramsey at 410-786-5262. For
all other issues call 410-786-1326.)
2. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Application for
Prescription Drug Plans (PDP); Application for Medicare Advantage
Prescription Drug (MA-PD); Application for Cost Plans to Offer
Qualified Prescription Drug Coverage; Application for Employer Group
Waiver Plans to Offer Prescription Drug Coverage; Service Area
Expansion Application for Prescription Drug Coverage; Use: The Medicare
Prescription Drug Benefit program was established by section 101 of the
Medicare Prescription Drug, Improvement, and Modernization Act of 2003
(MMA) and is codified in section 1860D of the Social Security Act (the
Act). Section 101 of the MMA amended Title XVIII of the Social Security
Act by redesignating Part D as Part E and inserting a new Part D, which
establishes the voluntary Prescription Drug Benefit Program (``Part
D''). The MMA was amended on July 15, 2008 by the enactment of the
Medicare Improvements for Patients and Providers Act of 2008 (MIPPA).
Coverage for the prescription drug benefit is provided through
contracted prescription drug plans (PDPs) or through Medicare Advantage
(MA) plans that offer integrated prescription drug and health care
coverage (MA-PD plans). Cost Plans that are regulated under Section
1876 of the Social Security Act, and Employer Group Waiver Plans (EGWP)
may also provide a Part D benefit. Organizations wishing to provide
services under the Prescription Drug Benefit Program must complete an
application, negotiate rates and receive final approval from CMS.
Existing Part D sponsors may also expand their contracted service area
by completing the Service Area Expansion (SAE) application. Refer to
supporting document ``Summary of Substantive and Technical Changes for
All Part D Application Revisions from 2010 Version of Part D
application to 2011 Draft Version'': Form Number: CMS-10137
(OMB: 0938-0936); Frequency: Reporting--Once; Affected Public:
Business or other for-profits and Not-for-profit institutions; Number
of Respondents: 453; Total Annual Responses: 453; Total Annual Hours:
11,919. (For policy questions regarding this collection contact Marla
Rothouse at 410-786-8063. For all other issues call 410-786-1326.)
3. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Request for
Expedited Review of Denial of Premium Assistance; Use: The American
Recovery and Reinvestment Act of 2009 provides for premium assistance
and expanded eligibility for health benefits under both the
Consolidated Omnibus Budget Reconciliation Act of 1986, commonly called
COBRA, and comparable State continuation coverage programs. This
premium assistance is not paid directly to the covered employee or the
qualified beneficiary, but instead is in the form of a tax credit for
the health plan, the employer, or the insurer. ``Assistance eligible
individuals'' pay only 35% of their continuation coverage premiums to
the plan and the remaining 65% is paid through the tax credit.
If an individual requests treatment as an assistance eligible
individual and the
[[Page 30575]]
employee's group health plan, employer, or insurer denies him or her
the reduced premium assistance, the Secretary of Health and Human
Services must provide for expedited review of the denial upon
application to the Secretary in the form and manner the Secretary
provides. The Secretary is required to make a determination within 15
business days after receipt of an individual's application for review.
The Request for Review If You Have Been Denied Premium Assistance
(the ``application'') is the form that will be used by individuals to
file their expedited review appeals. Each individual must complete all
information requested on the application in order for CMS to begin
reviewing his or her case. An application cannot be reviewed if
sufficient information is not provided. Refer to the supporting
document ``Crosswalk of Changes Between Request for Expedited Review of
Denial of Premium Assistance (4/09) and Request for Review if You Have
Been Denied Premium Assistance (6/09)'' for a list of changes: Form
Number: CMS-10285 (OMB: 0938-1062); Frequency: Reporting--
Once; Affected Public: Individuals and households; Number of
Respondents: 12,000; Total Annual Responses: 12,000; Total Annual
Hours: 12,000. (For policy questions regarding this collection contact
Jim Mayhew at 410-786-9244. For all other issues call 410-786-1326.)
4. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Conditions of
Certification for Rural Health Clinics and Supporting Regulations in 42
CFR 491.9, 491.10, 491.11; Use: The Rural Health Clinic (RHC)
conditions of certification are based on criteria prescribed in law and
are designed to ensure that each facility has a properly trained staff
to provide appropriate care and to assure a safe physical environment
for patients. The Centers for Medicare and Medicaid Services (CMS) uses
these conditions of participation to certify RHCs wishing to
participate in the Medicare program. These requirements are similar in
intent to standards developed by industry organizations such as the
Joint Commission on Accreditation of Hospitals, and the National League
of Nursing/American Public Association and merely reflect accepted
standards of management and care to which rural health clinics must
adhere. Form Number: CMS-R-38 (OMB: 0938-0334); Frequency:
Recordkeeping and Reporting--Annually and upon initial application for
Medicare approval; Affected Public: Business or other for-profits;
Number of Respondents: 3,937; Total Annual Responses: 3,937; Total
Annual Hours: 18,932. (For policy questions regarding this collection
contact Mary Collins at 410-786-3189. For all other issues call 410-
786-1326.)
5. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Information
Collection Requirements in HSQ-110, Acquisition, Protection and
Disclosure of Peer Review Organization Information and Supporting
Regulations in 42 CFR, Sections 480.104, 480.105, 480.116, and 480.134;
Use: The Peer Review Improvement Act of 1982 authorizes quality
improvement organizations (QIOs), formally known as peer review
organizations (PROs), to acquire information necessary to fulfill their
duties and functions and places limits on disclosure of the
information. The QIOs are required to provide notices to the affected
parties when disclosing information about them. These requirements
serve to protect the rights of the affected parties. The information
provided in these notices is used by the patients, practitioners and
providers to: obtain access to the data maintained and collected on
them by the QIOs; add additional data or make changes to existing QIO
data; and reflect in the QIO's record the reasons for the QIO's
disagreeing with an individual's or provider's request for amendment.
Form Number: CMS-R-70 (OMB: 0938-0426); Frequency: Reporting--
On occasion; Affected Public: Business or other for-profits; Number of
Respondents: 362; Total Annual Responses: 3729; Total Annual Hours:
60,919. (For policy questions regarding this collection contact Tom
Kessler at 410-786-1991. For all other issues call 410-786-1326.)
6. Type of Information Collection Request: New collection; Title of
Information Collection: Medicare Quality of Care Complaint Form; Use:
In accordance with Section 1154(a)(14) of the Social Security Act,
Quality Improvement Organizations (QIOs) are required to conduct
appropriate reviews of all written complaints submitted by
beneficiaries concerning the quality of care received. The Medicare
Quality of Care Complaint Form will be used by Medicare beneficiaries
to submit quality of care complaints. This form will establish a
standard form for all beneficiaries to utilize and ensure pertinent
information is obtained by QIOs to effectively process these
complaints. Form Number: CMS-10287 (OMB: 0938-New); Frequency:
Reporting--On occasion; Affected Public: Individuals or Households;
Number of Respondents: 3,500; Total Annual Responses: 3,500; Total
Annual Hours: 583. (For policy questions regarding this collection
contact Tom Kessler at 410-786-1991. For all other issues call 410-786-
1326.)
7. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Publication Usage
Survey; Use: The Publication Usage survey was developed to gather
information from people who request or access Medicare publications, to
ensure comprehension, usability, and use of the publications. CMS is
seeking understanding about whether publications have been effective in
informing members of the Medicare audience regarding policy and
benefits. Included in the survey are questions regarding the
satisfaction of publication users with specific publications and
whether the information they received informed them about the Medicare
program. Information gathered in this survey will be used only for
purposes of targeting and improving communications with Medicare
beneficiaries, caregivers, partners, and community organizations. Form
Number: CMS-10080 (OMB: 0938-0892); Frequency: Reporting--On
occasion; Affected Public: Individuals or Households; Number of
Respondents: 3,800; Total Annual Responses: 3,800; Total Annual Hours:
950. (For policy questions regarding this collection contact Renee
Clarke at 410-786-0006. For all other issues call 410-786-1326.)
8. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Durable Medical
Equipment Medicare Administrative Contractors (MAC), Certificates of
Medical Necessity; Use: The certificate of medical necessity (CMN)
collects information required to help determine the medical necessity
of certain items. CMS requires CMNs where there may be a vulnerability
to the Medicare program. Each initial claim for these items must have
an associated CMN for the beneficiary. Suppliers (those who bill for
the items) complete the administrative information (e.g., patient's
name and address, items ordered, etc.) on each CMN. The 1994 Amendments
to the Social Security Act require that the supplier also provide a
narrative description of the items ordered and all related accessories,
their charge for each of these items, and the Medicare fee schedule
allowance (where applicable). The supplier then sends the CMN to the
treating physician or other clinicians (e.g., physician assistant,
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LPN, etc.) who completes questions pertaining to the beneficiary's
medical condition and signs the CMN. The physician or other clinician
returns the CMN to the supplier who has the option to maintain a copy
and then submits the CMN (paper or electronic) to CMS, along with a
claim for reimbursement.
Due to a technical oversight on the part of CMS, an important
question on CMN Form 10269 was omitted from the last OMB submission
that would allow claims with an apnea-hypopnea index (AHI) or
respiratory disturbance index (RDI) greater than or equal to 5 without
symptoms for Criterion 2 be paid for by the Medicare program. The
omission of the following question ``Does the patient have documented
evidence of at least one of the following: Excessive daytime
sleepiness, impaired cognition, mood disorders, insomnia, hypertension,
ischemic heart disease or history of stroke'' could cause improper
payment of claims without regards as to whether the patient has signs
or symptoms in support of meeting the applicable coverage criteria for
PAP devices. We are resubmitting this information collection request to
have the revised CMN Form 10269 approved. None of the other CMN forms
have changed.
Form Number: CMS-846-849, 854, 10125, 10126, 10269 (OMB
0938-0679); Frequency: Occasionally; Affected Public: Business or other
for-profit and Not-for-profit institutions; Number of Respondents:
59,200; Total Annual Responses: 6,480,000; Total Annual Hours:
1,296,000. (For policy questions regarding this collection contact
Doris Jackson at (410) 786-4459. 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 on (410) 786-1326.
In commenting on the proposed information collections please
reference the document identifier or OMB control number. To be assured
consideration, comments and recommendations must be submitted in one of
the following ways by August 25, 2009:
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: June 18, 2009.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations
and Regulatory Affairs.
[FR Doc. E9-15193 Filed 6-25-09; 8:45 am]
BILLING CODE 4120-01-P