[Federal Register: March 19, 2009 (Volume 74, Number 52)]
[Notices]
[Page 11732-11734]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19mr09-55]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10164, CMS-10062, CMS-10137, CMS-416, CMS-
1557, CMS-2786, CMS-437A&B and CMS-10259]
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: Extension of a currently
approved collection;
Title of Information Collection: Electronic Data Interchange (EDI
Enrollment Form and Medicare EDI Registration Form; Form No.: CMS-10164
(OMB 0938-983); Use: Federal law requires that CMS take
precautions to minimize the security risk to Federal information
systems. Accordingly, CMS is requiring that trading partners who wish
to conduct the Electronic Data Interchange (EDI) transactions provide
certain assurances as a condition of receiving access to the Medicare
system for the purpose of conducting EDI exchanges. Health care
providers, clearinghouses, and health plans that wish to access the
Medicare system are required to complete this form. The information
will be used to assure that those entities that access the Medicare
system are aware of applicable provisions and penalties; Frequency:
Recordkeeping and Reporting--Other (one-time only); Affected Public:
Business or other for-profit, Not-for-profit institutions; Number of
Respondents: 240,000; Total Annual
[[Page 11733]]
Responses: 240,000; Total Annual Hours: 80,000. (For policy questions
regarding this collection contact Michael Cabral at 410-786-6168. For
all other issues call 410-786-1326.)
2. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Collection of
Diagnostic Data from Medicare Advantage Organizations for Risk Adjusted
Payments: Use: CMS requires hospital inpatient, hospital outpatient and
physician diagnostic data from Medicare Advantage (MA) organizations to
continue making payment under the risk adjustment methodology as
required by the Social Security Act, as amended by the Balanced Budget
Act; the Medicare, Medicaid and SCHIP Benefits Improvement and
Protection Act; and the Medicare Prescription Drug Benefit, Improvement
and Modernization Act. CMS will use the data to make risk adjusted
payment under Parts C. MA and MA-PD plans will use the data to develop
their Parts C bids. As required by law, CMS also annually publishes the
risk adjustment factors for plans and other interested entities in the
Advance Notice of Methodological Changes for MA Payment Rates (every
February) and the Announcement of Medicare Advantage Payment Rates
(every April). Lastly, CMS issues monthly reports to each individual
plan that contains the CMS-Hierarchical Condition Category (HCC) and
RxHCC models' output and the risk scores and reimbursements for each
beneficiary that is enrolled in their plan. Form Number: CMS-10062
(OMB 0938-0878); Frequency: Quarterly; Affected Public:
Business or other for-profit and Not-for-profit institutions; Number of
Respondents: 852; Total Annual Responses: 22,097,070; Total Annual
Hours: 10,826.1. (For policy questions regarding this collection
contact Henry Thomas at 410-786-0086. For all other issues call 410-
786-1326.)
3. Type of Information Collection Request: Extension 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 and under supporting
regulations Subpart K of 42 CFR 423 entitled ``Application Procedures
and Contracts with PDP Sponsors.'' 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. The information will be collected under
the solicitation of proposals from PDP, MA-PD, Cost Plan, PACE, and
EGWP Plan applicants. The collected information will be used by CMS to:
(1) Ensure that applicants meet CMS requirements, (2) support the
determination of contract awards. 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. (For policy questions regarding this collection contact Marla
Rothouse at 410-786-8063. For all other issues call 410-786-1326.)
4. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Annual Early and
Periodic Screening, Diagnostic and Treatment (EPSDT) Report; Use:
States are required to submit an annual report on the provision of
EPSDT services pursuant to section 1902(a)(43)(D) of the Social
Security Act. These reports provide CMS with data necessary to assess
the effectiveness of State EPSDT programs, to determine a State's
results in achieving its participation goal and to respond to
inquiries. This collection is being submitted as a revision based on
minor changes made to the form and instructions. CMS has added three
additional lines of data to the form (lines 12d, 12e and 12f). This
information is currently being collected; however, CMS expanded the
lines to obtain a better understanding for the utilization of dental
services. CMS believes there will be no additional burden for the
changes made to the form. The changes were necessary to accommodate a
need for more specific dental data and to preliminary notify States of
a change in CPT codes. A clarification was also made to line 14 of the
instructions. Form Number: CMS-416 (OMB 0938-0354); Frequency:
Yearly; Affected Public: State, Local or Tribal Governments; Number of
Respondents: 56; Total Annual Responses: 56; Total Annual Hours: 1,568.
(For policy questions regarding this collection contact Cindy Ruff at
410-786-5916. For all other issues call 410-786-1326.)
5. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Survey Report
Form for Clinical Laboratory Improvement Amendments (CLIA) and
Supporting Regulations in 42 CFR 493.1-493.2001; Use: This form is used
by the State to determine a laboratory's compliance with CLIA. This
information is needed for a laboratory's CLIA certification and
recertification. Form Number: CMS-1557 (OMB 0938-0544);
Frequency: Biennially; Affected Public: Business or other for-profit,
Not-for-profit institutions, State, Local or Tribal Governments and
Federal Government; Number of Respondents: 21,000; Total Annual
Responses: 10,500; Total Annual Hours: 5,248. (For policy questions
regarding this collection contact Kathleen Todd at 410-786-3385. For
all other issues call 410-786-1326.)
6. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Fire Safety
Survey Reports; Use: The Life Safety Code (LSC) is a compilation of
fire safety requirements for new and existing buildings and is updated
and published every 3 years by the National Fire Protection Association
(NFPA), a private, non-profit organization dedicated to reducing loss
of life due to fire. The Medicare regulations have historically
incorporated by reference these requirements along with Secretarial
waiver authority.
The statutory basis for incorporating NFPA's LSC for our providers
is under the Secretary's general rulemaking authority at Sections 1102
and 1871 of the Social Security Act. These forms are used by the State
Agencies to record data collected to determine compliance with
standards specified in 416.44(b) for ambulatory surgical centers
(ASCs), and 494.60(e) for End-Stage Renal Disease (ESRD) facilities.
The Medicare Health Insurance Program is authorized by Title XVIII of
the Social Security Act. The CMS-2786U form is being revised to include
ESRD information. Form Number: CMS-2786 (OMB 0938-
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0242); Frequency: Weekly; Affected Public: Individuals or households
and State, Local or Tribal Government; Number of Respondents: 54; Total
Annual Responses: 2442; Total Annual Hours: 4884. (For policy questions
regarding this collection contact JoAnn Perry at 410-786-3336. For all
other issues call 410-786-1326.)
7. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Rehabilitation
Hospital Criteria Worksheet and Rehabilitation Hospital Criteria
Worksheet; Use: The rehabilitation hospital and rehabilitation unit
criteria worksheets are necessary to verify that these facilities/units
comply and remain in compliance with the exclusion criteria for the
Medicare prospective payment system. Form Number: CMS-437A and 437B
(OMB 0938-0986); Frequency: Annually; Affected Public:
Business or other for-profit; Number of Respondents: 1227; Total Annual
Responses: 1227; Total Annual Hours: 307. (For policy questions
regarding this collection contact Georgia Johnson at 410-786-6859. For
all other issues call 410-786-1326.)
8. Type of Information Collection Request: New collection; Title of
Information Collection: State Plan Amendment Template for 1915(i) State
Plan Home and Community-Based Services (HCBS) Benefit; Use: Section
6086 of the Deficit Reduction Act (DRA), expanded access to HCBS for
the elderly and disabled and added a new section 1915(i) to the Social
Security Act. Under 1915(i), States can amend their State plans to add
these services. The template includes the information needed by CMS to
determine whether the State's services will meet the requirements under
1915(i). Form Number: CMS-10259 (OMB 0938-NEW); Frequency:
Once; Affected Public: State, Local or Tribal Governments; Number of
Respondents: 56; Total Annual Responses: 3; Total Annual Hours: 240.
(For policy questions regarding this collection contact Kathy Poisal at
410-786-5940. For all other issues call 410-786-1326.)
To obtain copies of the supporting statement and any related forms
for the proposed paperwork collections referenced above, access CMS Web
site address at http://www.cms.hhs.gov/PaperworkReductionActof1995, or
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 April 20, 2009.
OMB, Office of Information and Regulatory Affairs.
Attention: CMS Desk Officer.
Fax Number: (202) 395-6974.
E-mail: OIRA_submission@omb.eop.gov.
Dated: March 12, 2009.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations
and Regulatory Affairs.
[FR Doc. E9-6041 Filed 3-18-09; 8:45 am]
BILLING CODE 4120-01-P