[Federal Register: October 12, 2007 (Volume 72, Number 197)]
[Notices]
[Page 58096-58098]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12oc07-60]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10185, CMS-10137, CMS-10240, CMS-10237 and
10214, CMS-855, and CMS-R-39]
Agency Information Collection Activities: Submission for OMB
Review; 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), 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: Revision of a currently
approved collection; Title of Information Collection: Medicare Part D
[[Page 58097]]
Reporting Requirements and Supporting Regulations under 42 CFR section
423.505; Form Number: CMS-10185 (OMB: 0938-0992); Use: 42 CFR
423.514, requires each Part D Sponsor to have an effective procedure to
provide statistics indicating: The cost of its operations, the patterns
of utilization of its services, the availability, accessibility, and
acceptability of its services, information demonstrating it has a
fiscally sound operation and other matters as required by CMS. In
addition, Sec. 423.505 of the regulation, establishes a contract
provision that Part D Sponsors must comply with the reporting
requirements for submitting drug claims and related information to CMS.
Data collected via Medicare Part D Reporting Requirements will be an
integral resource for oversight, monitoring, compliance and auditing
activities necessary to ensure quality provision of the Medicare
Prescription Drug Benefit to beneficiaries. Refer to the ``Revisions
from 60-day Comment Period to CY 2008 Part D Reporting Requirements''
document to view a list of current changes. Frequency: Reporting--
Monthly, Annually, Quarterly and Semi-annually; Affected Public:
Business or other for-profit; Number of Respondents: 4,857; Total
Annual Responses: 330,276; Total Annual Hours: 287,132.
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: Collection
of this information is mandated in Part D of the Medicare Prescription
Drug, Improvement, and Modernization Act of 2003. The application
requirements are codified in Subpart K of 42 CFR 423. Coverage for the
prescription drug benefit is provided through prescription drug plans
(PDPs) that offer drug-only coverage, or through Medicare Advantage
(MA) organizations that offer integrated prescription drug and health
care coverage (MA-PD plans). PDPs must offer a basic drug benefit.
Medicare Advantage Coordinated Care Plans (MA-CCPs) must offer either a
basic benefit or may offer broader coverage for no additional cost.
Medicare Advantage Private Fee for Service Plans (MA-PFFS) may choose
to offer a Part D benefit. Cost Plans that are regulated under Section
1876 of the Social Security Act, and Employer Group Plans may also
provide a Part D benefit. If any of the contracting organizations meet
basic requirements, they may also offer supplemental benefits through
enhanced alternative coverage for an additional premium.
The information will be collected under the solicitation of
proposals from PDP, MA-PD, Cost Plan, and Employer Group Waiver Plans
applicants. The collected information will be used by CMS to: (1)
Insure that applicants meet CMS requirements, and (2) support the
determination of contract awards.
Refer to the ``High-Level Summary of Changes in Employer/Union
Group Waiver Plan Part D Applications'' and ``High-Level Summary of All
Part D Application Revisions from 2008 Solicitation for the 2009
Solicitation'' documents to review a list of changes from 2008 to 2009;
Form Number: CMS-10137 (OMB: 0938-0936); Frequency: Reporting:
Once; Affected Public: Business or other for-profit and Not-for-profit
institutions; Number of Respondents: 455; Total Annual Responses: 455;
Total Annual Hours: 11,890.
3. Type of Information Collection Request: New collection; Title of
Information Collection: Data Collection for the Nursing Home Value-
Based Purchasing (NHVBP) Demonstration; Use: The NHVBP Demonstration is
a CMS ``pay-for-performance'' initiative to improve the quality of care
furnished to Medicare beneficiaries residing in nursing homes. Under
this three-year demonstration project, CMS will assess the performance
of nursing homes based on selected quality measures, and then make
additional payments to those nursing homes that achieve a higher
performance based on those measures. In the first year of the
demonstration, quality will be assessed based on the following four
domains: Staffing, appropriate hospitalizations, outcome measures from
the minimum data set (MDS), and survey deficiencies. Additional quality
measures may be added in the second and third years of the
demonstration as deemed appropriate.
The main purpose of the NHVBP data collection effort is to gather
information that will enable CMS to determine which nursing homes will
be eligible to receive incentive payments under the NHVBP
Demonstration. All measures included in the MDS outcomes, survey
deficiency, and appropriate hospitalization domains can be calculated
from existing secondary data sources, such as the MDS, annual nursing
home certification surveys, and Medicare claims data. However, for the
staffing domain, no satisfactory alternative source for these data has
been identified. Therefore, CMS will collect payroll-based staffing and
resident census information to help assess the quality of care in
participating nursing homes. CMS will additionally collect data on two
measures, staff immunization status and use of resident care experience
surveys, which may be included in the payment determination during the
second and third years of the demonstration. Refer to the ``Summary of
Changes to Data collection for the Nursing Home Value-Based Purchasing
(NHVBP) Demonstration'' documents to review a list of changed items.
Form Number: CMS-10240 (OMB: 0938-New); Frequency: Reporting:
Once; Affected Public: Business or other for-profit and Not-for-profit
institutions; Number of Respondents: 1,250; Total Annual Responses:
2,000; Total Annual Hours: 49,170.
4. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Medicare
Advantage (MA) Applications--Part C; Use: An entity seeking a contract
as an MA organization must be able to provide Medicare's basic benefits
plus meet the organizational requirements set out in regulations at 42
CFR Part 422. An applicant must demonstrate that it can meet the
benefit and other requirements within the specific geographic area it
is requesting. The application forms are designed to give CMS the
information they need about the health plan to determine compliance
with Federal regulations at 42 CFR Part 422 in an efficient manner. The
cited regulations outline the MA application process that begins with
submission of an application in the form and manner that the Secretary
provides. The MA application forms will be used by CMS to determine
whether an entity is eligible to enter into a contract to provide
services to Medicare beneficiaries. Refer to the ``High Level Summary
of Key Changes Between The 2008 Part C Applications and The 2009 Part C
Applications'' and the ``High-Level Summary of Changes in Employer/
Union-Only Group Waiver Plan MAO Applications'' documents to review a
list of the changes. Form Number: CMS-10237 and 10214 (OMB:
0938-0935); Frequency: Reporting: Yearly; Affected Public: Business or
other for-profit and Not-for-profit institutions; Number of
Respondents: 241; Total Annual
[[Page 58098]]
Responses: 241; Total Annual Hours: 5858.
5. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Medicare
Enrollment Application; Form Number: CMS-855 (OMB: 0938-0685);
Use: The primary function of the 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 information necessary to
establish the correct claims payment. The goal of evaluating and
revising the Medicare enrollment applications is to simplify and
clarify the information collection without jeopardizing our need to
collect specific information.
We are proposing revisions to the CMS-855B to incorporate changes
adopted in CMS-1321-FC (71 FR 69624), ``Revisions to Payment Policies
and Five-Year Review of Relative Value Units Under the Physician Fee
Schedule for CY 2007 and Other Changes to Payment Under Part B;
Revisions to Ambulance Fee Schedule; Ambulatory Inflation Factor Update
for CY 2007.'' Specifically, CMS is revising the CMS-855B to:
Add instructions to Attachment 2 that explain the
independent diagnostic testing facility (IDTF) liability insurance
requirements in 42 CFR Sec. 410.33(g)(6).
Require that an IDTF submit copies of its comprehensive
liability insurance policy in Section 17.
List all of the new IDTF standards on a separate page in
Attachment 2.
Remove the supplier type ``Voluntary Health/Charitable
Agency'' from Section 2A.
In addition, we are trying to enhance our ability to identify
whether a hospital qualifies as a ``specialty hospital.'' To this end,
we propose to revise the CMS-855A to include a specific box that
specialty hospitals must check when completing the application.
Instructions explaining the definition of a ``specialty hospital'' will
also be added to the form. We also provide clarification of the term
``primary practice location'' in the instructions in Section 4 of the
CMS-855A. This clarification does not change any data elements on the
form. We are also removing the data element ``Medicare Year-End Cost
Report Date'' in Section 2 of the CMS-855A, as this information is no
longer needed. Frequency: Recordkeeping and Reporting--On occasion;
Affected Public: Business or other for-profit and Not-for-profit
institutions; Number of Respondents: 400,000; Total Annual Responses:
400,000; Total Annual Hours: 1,001,503.33.
6. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Home Health
Conditions of Participation (CoP) Information Collection Requirements
and Supporting Regulations in 42 CFR 484.10, 484.12, 484.16, 484.18,
484.36, 484.48, 484.52; Form Numbers: CMS-R-39 (OMB: 0938-
0365); Use: The information collection requirements contained in this
request are part of the requirements classified as the conditions of
participation (CoPs) which are based on criteria prescribed in law and
are standards designed to ensure that each facility has properly
trained staff to provide the appropriate safe physical environment for
patients. These particular standards reflect comparable standards
developed by industry organizations such as the Joint Commission on
Accreditation of Healthcare Organizations, and the Community Health
Accreditation Program. The primary users of this information will be
State agency surveyors, the regional home health intermediaries, CMS
and home health agencies (HHAs) for the purpose of ensuring compliance
with Medicare CoPs as well as ensuring the quality of care provided by
HHA patients. Frequency: Recordkeeping and Reporting--Annually, On
occasion; Affected Public: Business or for-profits, Not-for-profit
institutions, and State, Local or Tribal governments; Number of
Respondents: 9,354; Total Annual Responses: 9,354; Total Annual Hours:
1,048,483.5.
To obtain copies of the supporting statement and any related forms
for the proposed paperwork collections referenced above, access CMS Web
Site address at http://www.cms.hhs.gov/PaperworkReductionActof1995, or
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.
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 November 13,
2007.
OMB Human Resources and Housing Branch, Attention: Carolyn Lovett,
New Executive Office Building, Room 10235, Washington, DC 20503, Fax
Number: (202) 395-6974.
Dated: October 4, 2007.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations
and Regulatory Affairs.
[FR Doc. E7-20150 Filed 10-11-07; 8:45 am]
BILLING CODE 4120-01-P