[Federal Register: June 26, 2009 (Volume 74, Number 122)]
[Notices]
[Page 30574-30576]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26jn09-74]
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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
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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,
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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 Paperwork@cms.hhs.gov, 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