[Federal Register Volume 73, Number 198 (Friday, October 10, 2008)]
[Notices]
[Pages 60296-60297]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-24093]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-R-262, CMS-10142, CMS-10175 and CMS-R-218]


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: CY 2010 Plan 
Benefit Package (PBP) and Formulary Submission for Medicare Advantage 
(MA) Plans and Prescription Drug Plans (PDP) Use: Under the Medicare 
Modernization Act (MMA), Medicare Advantage (MA) and Prescription Drug 
Plan (PDP) organizations are required to submit plan benefit packages 
for all Medicare beneficiaries residing in their service area. The plan 
benefit package submission consists of the formulary file, Plan Benefit 
Package (PBP) software, and supporting documentation as necessary. MA 
and PDP organizations will generate a formulary to illustrate their 
list of drugs, including information on prior authorization, step 
therapy, tiering, and quantity limits. Additionally, the PBP software 
will be used to describe their organization's plan benefit packages, 
including information on premiums, cost sharing, authorization rules, 
and supplemental benefits. CMS uses the formulary and PBP data to 
review and approve the plan benefit packages proposed by each MA and 
PDP organization.
    CMS requires that MA and PDP organizations submit a completed 
formulary and PBP as part of the annual bidding process. During this 
process, organizations prepare their proposed plan benefit packages for 
the upcoming contract year and submit them to CMS for review and 
approval. Based on operational changes and policy clarifications to the 
Medicare program and continued input and feedback by the industry, CMS 
has made the necessary changes to the plan benefit package submission. 
Form Number: CMS-R-262 (OMB 0938-0763); Frequency: Yearly; 
Affected Public: Business or other for-profits b. Not-for-profit 
institutions; Number of Respondents: 475; Total Annual Responses: 
4987.5; Total Annual Hours: 12112.5.
    2. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: CY 2010 Bid 
Pricing Tool (BPT) for Medicare Advantage (MA) Plans and Prescription 
Drug Plans (PDP). Use: Under the Medicare Prescription Drug, 
Improvement, and Modernization Act of 2003 (MMA), and implementing 
regulations at 42 CFR, Medicare Advantage organizations (MAO) and 
Prescription Drug Plans (PDP) are required to submit an actuarial 
pricing ``bid'' for each plan offered to Medicare beneficiaries for 
approval by CMS. MAOs and PDPs use the Bid Pricing Tool (BPT) software 
to develop their actuarial pricing bid. The information provided in the 
BPT is the basis for the plan's enrollee premiums and CMS payments for 
each contract year. The tool collects data such as medical expense 
development (from claims data and/or manual rating), administrative 
expenses, profit levels, and projected plan enrollment information. By 
statute,

[[Page 60297]]

completed BPTs are due to CMS by the first Monday of June each year. 
CMS reviews and analyzes the information provided on the Bid Pricing 
Tool. Ultimately, CMS decides whether to approve the plan pricing 
(i.e., payment and premium) proposed by each organization. Form Number: 
CMS-10142 (OMB 0938-0944); Frequency: Yearly; Affected Public: 
Business or other for-profits b. Not-for-profit institutions; Number of 
Respondents: 550; Total Annual Responses: 6050; Total Annual Hours: 
42,350.
    3. Type of Information Collection Request: Reinstatement without 
change of a previously approved collection; Title of Information 
Collection: Certification Statement for Electronic File Interchange 
Organizations (EFIOs) Use: Health care providers can currently obtain a 
National Provider Identifier (NPI) via a paper application or over the 
Internet through the National Plan and Provider Enumeration System 
(NPPES). These applications must be submitted individually, on a per-
provider basis. The Electronic File Interchange (EFI) process allows 
provider-designated electronic file interchange organizations (EFIOs) 
to capture multiple providers' NPI application information on a single 
electronic file for submission to NPPES. This process is also referred 
to as ``bulk enumeration.'' To ensure that the EFIO has the authority 
to act on behalf of each provider and complies with other Federal 
requirements, an authorized official of the EFIO must sign a 
certification statement and mail it to the Centers for Medicare and 
Medicaid Services (CMS). Form Number: CMS-10175 (OMB 0938-
0984); Frequency: Once; Affected Public: Private Sector--Business or 
other for-profits; Number of Respondents: 300; Total Annual Responses: 
300; Total Annual Hours: 300.
    4. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Information 
Collection Requirements contained in 45 CFR Part 162; HIPAA Standards 
for Electronic Transactions. Use: We are revising the currently 
approved information collection request to include the information 
collection requirements contained in CMS-0009-P (73 FR 49742). In the 
aforementioned regulation, we update the adopted standards for 
electronic transactions and propose the adoption of a new standard 
transaction for Medicaid subrogation for retail pharmacy claims. The 
use of these updated and additional standards would improve the 
Medicare and Medicaid programs and other Federal health programs as 
well as private health programs, and the effectiveness and efficiency 
of the health care industry in general, by simplifying the 
administration of the system and fostering and increase in EDI for 
exchanging healthcare information. Increased advances in technology and 
improvements in healthcare business processes have fostered development 
of updated EDI standards to facilitate efficient and effective flow of 
administrative operations. Adopting an updated version of the standards 
and a new standard for Medicaid subrogation would greatly improve EDI 
standardization for healthcare transactions. Form Number: CMS-R-218 
(OMB 0938-0866); Frequency: Once; Affected Public: Private 
Sector--Business or other for-profits and Not-for-profit institutions; 
Number of Respondents: 696,026; Total Annual Responses: 696,026; Total 
Annual Hours: 6,960,260.
    To obtain copies of the supporting statement and any related forms 
for the proposed paperwork collections referenced above, access CMS' 
Web site at http://www.cms.hhs.gov/PaperworkReductionActof1995, or E-
mail your request, including your address, phone number, OMB number, 
and CMS document identifier, to [email protected], 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 December 9, 2008:
    1. Electronically. You may submit your comments electronically to 
http://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: October 2, 2008.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations 
and Regulatory Affairs.
[FR Doc. E8-24093 Filed 10-9-08; 8:45 am]
BILLING CODE 4120-01-P