[Federal Register Volume 76, Number 58 (Friday, March 25, 2011)]
[Notices]
[Pages 16790-16792]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-7104]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare and Medicaid Services

[Document Identifier CMS-370, CMS-377, CMS-378; CMS-10145, CMS-10362, 
CMS-10384, CMS-10342 and CMS-10338]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers 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 & 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; Titles of Information Collection: (CMS-370) Health 
Insurance Benefits Agreement, (CMS-377) ASC Request for Certification 
or Update of Certification Information in the Medicare Program, and 
(CMS-378) Ambulatory Surgical Center (ASC) Survey Report Form; Use: 
CMS-370 has not been revised and will continue to be used to establish 
eligibility for payment under Title XVIII of the Social Security Act 
(the ``Act''). As revised, CMS-377 will be used to collect facility-
specific characteristics that facilitate CMS' oversight of ASCs. The 
data also enables CMS to respond to inquiries from the Congress, GAO, 
and the OIG concerning the characteristics of Medicare-participating 
ASCs. The data base that supports survey and certification activities 
will be revised to reflect changes in the data fields on this revised 
form, such as the data on the types of surgical procedures performed in 
the ASC. CMS-378 will be discontinued since it duplicates information 
collected by other means; Form Numbers: CMS-370, -377 and -378 (OCN: 
0938-0266); Frequency: Occasionally (initially an then every three 
years); Affected Public: Private Sector: Business or other for-profit 
and Not-for-profit institutions; Number of Respondents: 7,213; Total 
Annual Responses: 1,795; Total Annual Hours: 648. (For policy questions 
regarding this collection contact Gail Vong at 410-786-0787. For all 
other issues call 410-786-1326.)
    2. Type of Information Collection Request: Extension without change 
of a currently approved collection; Title of Information Collection: 
Medicare Part B Drug and Biological Competitive Acquisition Program 
(CAP) and Supporting Regulations in 42 CFR Sections 414.906, 414.908, 
414.910, 414.914, 414.916, and 414.917; Use: Section 303(d) of the 
Medicare Prescription Drug, Improvement, and Modernization Act of 2003 
(MMA) provides an alternative payment methodology for Part B covered 
drugs that are not paid on a cost or prospective payment basis. In 
particular, Section 303(d) of the MMA amends Title XVIII of the Social 
Security Act by adding a new section 1847B, which establishes a 
competitive acquisition program for the acquisition of and payment for 
Part B covered drugs and biologicals furnished on or after January 1, 
2006. Since its inception, additional legislation has augmented the 
CAP. Section 108 of the Medicare Improvements and Extension Act under 
Division B, Title I of the Tax Relief Health Care Act of 2006 (MIEA-
TRHCA) amended Section 1847b(a)(3) of the Social Security Act and 
requires that CAP implement a post payment review process. This 
procedure is done to assure that payment is made for a drug or 
biological under this section only if the drug or biological has been 
administered to a beneficiary. Form Number: CMS-10145 (OCN: 0938-0945); 
Frequency: Weekly, quarterly and occasionally; Affected Public: Private 
sector--Business or other for-profit and Not-for-profit institutions; 
Number of Respondents: 3000; Total Annual Responses: 156,020; Total 
Annual Hours: 31,208.
    3. Type of Information Collection Request: New collection; Title of 
Information Collection: Autism Spectrum Disorders (ASD): State of the 
States Services and Supports for People with ASD; Use: The information 
that is collected in the interviews will be used to communicate 
additional information about services available to people with ASD and 
the public policy issues that affect people with ASD to key stakeholder 
audiences. The format of the report will include data tables from 
various state programs and narrative about the data being presented 
based on the interviews with state agency staff. We propose 
interviewing multiple staff in each state because several state 
agencies have an impact on services and supports for people with ASD; 
Form Number: CMS-10362 (OCN: 0938-New); Frequency: Once; Affected 
Public: State, local, or Tribal Governments; Number of Respondents: 
459; Total Annual Responses: 459; Total Annual Hours: 803. (For policy 
questions regarding this collection contact Ellen Blackwell at 410-786-
4498. For all other issues call 410-786-1326.)
    4. Type of Information Collection Request: New Collection; Title of 
Information Collection: Health Insurance Assistance Database; Use: In 
October 2010, the Office of Consumer Support began to take and respond 
to direct consumer inquiries related to the Affordable Care Act. As of 
February 15th 2011, CCIIO has received 906 consumer inquiries. Consumer 
inquiries continue to come in to CCIIO at a rate of 30 to 35 inquiries 
per week. Starting in January 2011, the HHS Hotline will begin to refer 
ACA calls to CCIIO. To date, the HHS Hotline receives, on average, 400 
calls per month pertaining to ACA.
    Accordingly, a system to collect, track and store consumer 
information is urgently needed in order to accomplish

[[Page 16791]]

successful case management to ensure that the information, coverage, 
and health care needs of consumers are addressed fairly and in a timely 
fashion. Further, the Team will provide detailed reports on these 
consumer inquiries with a focus on Affordable Care Act and PHS Act 
compliance issues. These reports will assist the Office of Oversight in 
identifying areas where compliance concerns may arise. Reports will be 
stripped of any information in identifiable form (IIF) and personal 
health information when written and prepared. Authority for 
maintenance, collection and disclosures of this information is given 
under sections 2719, 2723, and 2761 of the Public Health Service Act 
(PHS Act) and section 1321(c) of the Affordable Care Act.
    Analysis of this data reporting will help identity patterns of 
practice in the insurance marketplaces and uncover suspected patterns 
of noncompliance. HHS may share program data reports with the 
Departments of Labor and Treasury, and State regulators. Program data 
also can offer CCIIO one indication of the effectiveness of State 
enforcement, affording opportunities to provide technical assistance 
and support to State insurance regulators and, in extreme cases, inform 
the need to trigger federal enforcement. Form Number: CMS-10384 (OCN: 
0938-New); Frequency: Occasionally; Affected Public: Individuals or 
households; Number of Respondents: 1200; Number of Responses: 1,860; 
Total Annual Hours: 195 (For policy questions regarding this 
collection, contact Paul Tibbits (301) 492-4229. For all other issues 
call (410) 786-1326.)
    5. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Annual Limits 
Waiver Online Application Form; Use: Under section 2711(a)(2) of the 
Public Health Service Act, as amended by the Affordable Care Act 
section 1302(b), The Secretary of Health and Human Services is required 
to impose restrictions on the dollar value of essential benefits 
provided by new or existing group health plans or individual policies 
in the market between September 23, 2010 and January 1, 2014. The 
interim final regulations published June 28, 2010 (45 CFR Sec.  
147.126) give the Secretary the authority to waive these restricted 
annual limits if compliance would result in a significant increase in 
premium or significant decrease in access to benefits for those already 
covered. CMS is in the process of evaluating applications for waivers 
of annual limits and seeks to publish an updated Microsoft Excel 
spreadsheet to standardize and simplify the data collection process. 
Applicants must fill out (1) spreadsheet per application. The 
spreadsheet is a mandatory component of each waiver application 
necessary to fulfill the statutory requirements under section 
2711(a)(2) of the Public Health Service Act. The information collected 
includes applicant contact information; information about the annual 
limit(s) on the overall plan or policy and on essential health benefits 
(as defined by the Affordable Care Act section 1302(b)); information 
about plan design such as copayment, coinsurance, and deductibles; 
financial projections by enrollee tier; and a description of how a 
significant decrease in access to benefits would result from compliance 
with section 2711(a)(2) of the Affordable Care Act. This information is 
required to accurately and objectively assess whether compliance with 
the restricted annual limits would result in the aforementioned 
significant increase in premium or significant decrease in access to 
benefits, on which the grant of a waiver is conditioned in the interim 
final regulations. The updated spreadsheet contains a more detailed 
description of what values should be entered into each cell. This 
description should save applicants time when completing the spreadsheet 
initially, and it should lessen the need for applicants to go back and 
correct mistakes after submission. Form Number: CMS-10342 (OCN: 0938-
1105); Frequency: Annually; Affected Public: Private Sector; Number of 
Respondents: 4,872; Number of Responses: 4,608,372; Total Annual Hours: 
178,183. (For policy questions regarding this collection, contact Erika 
Kottenmeier at (301) 492-4170. For all other issues call (410) 786-
1326.)
    6. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Affordable Care 
Act Internal Claims and Appeals and External Review Procedures for Non-
grandfathered Group Health Plans and Issuers and Individual Market 
Issuers; Use: The Patient Protection and Affordable Care Act, Public 
Law 111-148, (the Affordable Care Act) was enacted by President Obama 
on March 23, 2010. As part of the Act, Congress added PHS Act section 
2719, which provides rules relating to internal claims and appeals and 
external review processes. These interim final regulations (IFR) set 
forth rules implementing PHS Act section 2719 for internal claims and 
appeals and external review processes. With respect to internal claims 
and appeals processes for group health coverage, PHS Act section 2719 
and paragraph (b)(2)(i) of the interim final regulations provide that 
group health plans and health insurance issuers offering group health 
insurance coverage must comply with the internal claims and appeals 
processes set forth in 29 CFR 2560.503-1 (the DOL claims procedure 
regulation) and update such processes in accordance with standards 
established by the Secretary of Labor in paragraph (b)(2)(ii) of the 
regulations. Paragraph (b)(3)(i) requires issuers offering coverage in 
the individual health insurance market to also comply with the DOL 
claims procedure regulation as updated by the Secretary of HHS in 
paragraph (b)(3)(ii) of the interim final regulations for their 
internal claims and appeals processes.
    The DOL claims procedure regulation requires plans to provide every 
claimant who is denied a claim with a written or electronic notice that 
contains the specific reasons for denial, a reference to the relevant 
plan provisions on which the denial is based, a description of any 
additional information necessary to perfect the claim, and a 
description of steps to be taken if the participant or beneficiary 
wishes to appeal the denial. The regulation also requires that any 
adverse decision upon review be in writing (including electronic means) 
and include specific reasons for the decision, as well as references to 
relevant plan provisions. In addition, paragraph (b)(3)(ii)(C) of the 
interim final regulations adds an additional requirement that non-
grandfathered ERISA-covered group health plans provide to the claimant, 
free of charge, any new or additional evidence considered relied upon, 
or generated by the plan or issuer in connection with the claim.
    Also PHS Act section 2719 and these interim final regulations 
provide that group health plans and issuers offering group health 
insurance coverage must comply either with a State external review 
process or a Federal review process. The regulations provide a basis 
for determining when plans and issuers must comply with an applicable 
State external review process and when they must comply with the 
Federal external review process. Form Number: CMS-10338 (OCN: 0938-
1099); Frequency: Occasionally; Affected Public: State, Local, Tribal 
Governments; Number of Respondents: 36,344; Number of Responses: 
2,762,824; Total Annual Hours: 211,216,845. (For policy questions 
regarding this collection,

[[Page 16792]]

contact Tara Oakman at (301) 492-4253. 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 <a href="/cdn-cgi/l/email-protection#c292a3b2a7b0b5adb0a982a1afb1ecaaaab1eca5adb4"><span class="__cf_email__" data-cfemail="83d3e2f3e6f1f4ecf1e8c3e0eef0adebebf0ade4ecf5">[email protected]</span></a>, or call the 
Reports Clearance Office at 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 May 24, 2011:
    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: March 18, 2011.
Martique Jones,
Director, Regulations Development Group, Division B, Office of 
Strategic Operations and Regulatory Affairs.
[FR Doc. 2011-7104 Filed 3-24-11; 8:45 am]
BILLING CODE 4120-01-P


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