[Federal Register Volume 74, Number 122 (Friday, June 26, 2009)]
[Notices]
[Pages 30574-30576]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-15193]


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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,

[[Page 30576]]

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 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 August 25, 2009:
    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: 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