E8-21669. Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB)

AGENCY:

Center for Medicare and 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 and 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 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.

We are, however, requesting an emergency review of the information collection referenced below. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, we have submitted to the Office of Management and Budget (OMB) the following requirements for emergency review. We are requesting an emergency review because the collection of this information is needed before the expiration of the normal time limits under OMB's regulations at 5 CFR part 1320(a)(2)(iii). This is necessary to ensure compliance with an initiative of the Administration. We cannot reasonably comply with the normal clearance procedures because the use of normal clearance procedures is reasonably likely to cause a statutory deadline to be missed.

The Balanced Budget Act of 1997, established a new “Part C” in the Medicare statute, sections 1851 through 1859 of the Social Security Act, which provided for a Medicare+Choice (M+C) program. The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) was enacted on December 8, 2003. The MMA established the Medicare Prescription Drug Benefit Program under section 101 of the MMA and is codified in section 1860D of the Social Security Act which establishes the voluntary 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). The MMA was amended on July 15, 2008 by the enactment of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA).

CMS is in the process of publishing regulations that are intended to be released as an interim final rule with comment. Many of the provisions included in MIPPA that impact the Part C and Part D programs are self-implementing, meaning these provisions will go into effect without any further regulatory clarification or changes to the Part C and Part D solicitations. As part of the revised information collection request, CMS will implement into the Part C solicitations, sections 163, 164, and 165 of MIPPA, and implement into the Part D solicitations, sections 171, 172 and 173 of MIPPA. These sections amend the contractual requirements that Part C and Part D sponsors (applicants) must have with CMS and with any downstream or related entities performing Part C and Part D functions on the sponsor's behalf. Currently CMS provides templates that contain the required language for the contracts based on the statute and regulations. While applicants do not have to use the exact CMS contract templates, they will be responsible for including the required language in the contracts when they submit materials to CMS for the 2010 contract year.

The solicitations do not represent new policy, but rather implement the provisions that will exist in the forthcoming regulations, and include clarifying edits and updates as well. Therefore, CMS is seeking an emergency PRA clearance to amend the Part C and Part D solicitations to reflect the new MIPPA requirements.

1. 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 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.

2. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Medicare Advantage Applications—Part C; Use: Collection of this information is mandated in Part C of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA) in Subpart K of 42 CRF 422 entitled “Contracts with Medicare Advantage Organizations.” Under section 1851(a)(1) of the Act, every individual entitled to Medicare Part A and enrolled under Part B, except for most individuals with end-stage renal disease, 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.

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. The information will be collected under the solicitation of proposals from MA-PD, Cost Plan, EGWP Plan applicants. The collection information will be used by CMS to: (1) ensure that applicants meet CMS requirements, (2) support the determination of contract awards. 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: 267; Total Annual Responses: 267; Total Annual Hours: 6,709.

CMS is requesting OMB review and approval of this collection by December 12, 2008, with a 180-day approval period. Written comments and recommendation will be considered from the public if received by the individuals designated below by the noted deadline below.

To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS's 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 [e-mail], or call the Reports Clearance Office on [phone].

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 October 20, 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; and, OMB Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, New Executive Office Building, Room 10235, Washington, DC 20503, Fax Number: [phone].

Dated: September 8, 2008.

Michelle Shortt,

Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs.