[Federal Register Volume 76, Number 48 (Friday, March 11, 2011)]
[Notices]
[Pages 13415-13418]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-5684]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-2540-10, CMS-10115, CMS-10136, CMS-10260, 
CMS-10320, CMS-10381, CMS-855(S), CMS-855(A, B, I, R) and CMS-855(O)]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & 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; Title of Information Collection: Skilled Nursing 
Facility and Skilled Nursing Facility Health Care Complex Cost Report. 
Use: Form CMS 2540-10 is used by Skilled Nursing Facilities (SNFs) and 
Skilled Nursing Facility Complexes participating in the Medicare 
program to report the health care costs to determine the amount of 
reimbursable costs for services rendered to Medicare beneficiaries. It 
is required under sections 1815(a), 1833(e) and 1861(v)(1)(A) of the 
Social Security Act (42 U.S.C. 1395g) to submit annual information to 
achieve settlement of costs for health care services rendered to 
Medicare beneficiaries. The revision is due to new reporting 
requirements as mandated by the Patient Protection and Affordability 
Act section 6104. The Patient Protection and Affordable Care Act, Sec.  
6104(1) of Public Law 111-148 amended Sec.  1888(f) of the Social 
Security Act (``Reporting of Direct Care Expenditures''), requires SNFs 
to separately report expenditures for wages and benefits for direct 
care staff (registered nurses, licensed professional nurses, certified 
nurse assistants, and other medical and therapy staff). In implementing 
these changes Worksheet S-3, part V was added. With the addition of 
this worksheet the average record keeping time for each provider will 
be increased by 5 hours and the average reporting time by 1 hour. Form 
Number: CMS-2540-10 (OMB: 0938-0463); Frequency: Yearly; 
Affected Public: Private Sector; Business or other for-profit and not-
for-profit institutions; Number of Respondents: 15,071; Total Annual 
Responses: 15,071; Total Annual Hours: 3,171,602 (For policy questions 
regarding this collection contact Amelia Citerone at 410-786-3901. For 
all other issues call 410-786-1326.)
    2. Type of Information Collection Request: Extension of currently 
approved collection; Title of

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Information Collection: Federal Reimbursement of Emergency Health 
Services Furnished to Undocumented Aliens (Sections 1011) Provider 
Enrollment Application; Use: Section 1011 of the Medicare Prescription 
Drug, Improvement, and Modernization Act of 2003, provides that the 
Secretary will establish a process (i.e., enrollment and claims 
payment) for eligible providers to request payment. The Secretary must 
directly pay hospitals, physicians and ambulance providers (including 
Indian Health Service, Indian Tribe and Tribal organizations) for their 
otherwise un-reimbursed costs of providing services required by section 
1867 of the Social Security Act (EMTALA) and related hospital 
inpatient, outpatient and ambulance services. CMS will use the 
application information to administer this health services program and 
establish an audit process. The Federal Reimbursement of Emergency 
Health Services Furnished to Undocumented Aliens (Sections 1011) 
Provider Enrollment Application has been revised. For a list of these 
revisions, refer to the summary of changes document.
    Form Number: CMS-10115 (OMB 0938-0929); Frequency: On 
occasion; Affected Public: Private sector--Business or other for-profit 
and Not-for-profit institutions; Number of Respondents: 5,000; Total 
Annual Responses: 5,000; Total Annual Hours: 2,999.
    3. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Medicare 
Demonstration Ambulatory Care Quality Measure Performance Assessment 
Tool (``PAT''); Use: This request is to cover a modification of an 
existing, approved data collection effort with a new secure Web based 
system. This system will also provide a platform for developing tools 
to collect clinical quality data for future demonstrations and 
programs. There is no increase in burden. In fact, because all of the 
practices submitting data will have Electronic Health Records (EHRs), 
it is likely that the originally estimated burden will decrease over 
the coming years of the demonstration. CMS is requesting an extension 
of the currently approved tool for the collection of ambulatory care 
clinical performance measure data.
    The data will be used to continue implementation of two 
Congressionally mandated demonstration projects (the Physician Group 
Practice (PGP) Demonstration and the Medicare Care Management 
Performance (MCMP) Demonstration); also the support data collection 
under the new EHR Demonstration. Each of these demonstrations, test new 
payment methods for improving the quality and efficiency of health care 
services delivered to Medicare fee-for-service beneficiaries, 
especially those with chronic conditions that account for a 
disproportionate share of Medicare expenditures. In addition, the MCMP 
and EHR demonstration specifically encourage the adoption of electronic 
health records systems as a vehicle for improving how health care is 
delivered.
    4. Type of Information Collection Request: Extension without 
change; Title of Information Collection: Medicare Advantage and 
Prescription Drug Program: Final Marketing Provisions CFR 422.111(a)(3) 
and 423.128 (a)(3). Use: Medicare Advantage (MA) plans must provide 
notice to plan members of impending changes to plan benefits, premiums 
and copays in the coming year so that members will be in the best 
position to make an informed choice on continued enrollment or 
disenrollment from that plan at least 15 days before the Annual 
Election Period (AEP). Beginning 2009, organizations will be required 
to notify plan members of the coming year changes using a combined 
standardized document at the time of enrollment and annually 
thereafter.
    Section 422.111 requires, to the extent that a MA plan has a Web 
site, annual notification through the Web site of written, hard copy 
notification sent to the beneficiaries. Section 423.128 requires that a 
part D plan have mechanisms for providing specific information on a 
timely basis to current and prospective enrollees upon request.
    These mechanisms include, Internet Web site that includes 
information on part D plan description. MA organizations (formerly M+C 
organizations) and Prescription Drug Plan Sponsors use the information 
to comply with the eligibility requirements and the MA and part D 
contract requirements. CMS will use this information to ensure that 
correct information is disclosed to Medicare beneficiaries, both 
potential enrollees and enrollees. Form Number: CMS-10260 
(OMB: 0938-1051); Frequency: Reporting--Yearly; Affected 
Public: Business or other for-profits; Number of Respondents: 790; 
Total Annual Responses: 790; Total Annual Hours: 9,480. (For policy 
questions regarding this collection contact Camille Brown at 410-786-
0274. For all other issues call 410-786-1326.)
    5. Type of Information Collection Request: Reinstatement of 
previously approved collection; Title of Information Collection: Health 
Care Reform Insurance Web Portal Requirements 45 CFR part 159; Use: In 
compliance with the requirement of section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995, the Center for Consumer Information 
and Insurance Oversight, Centers for Medicare and Medicaid Services, 
Department of Health and Human Services, is publishing the following 
summary of a proposed information collection request 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.
    This information collection is mandated by Sections 1103 and 10102 
of The Patient Protection and Affordability Care Act, Public Law 111-
148 (ACA). Once all of the information is collected from insurance 
issuers of major medical health insurance (hereon referred to as 
issuers) and other affected parties, it will be processed for will 
display at http://www.healthcare.gov with quarterly refreshes. The 
information that is provided will help the general public make educated 
decisions about organizations providing private health care insurance.
    In accordance with the provisions of the ACA referenced above, the 
U.S. Department of Health and Human Services created a Web site called 
healthcare.gov to meet these and other provisions of the law, and data 
collection was conducted for six months based upon an emergency 
information collection request. The interim final rule published on May 
5, 2010 served as the emergency Federal Register Notice for the prior 
Information Collection Request (ICR). The Office of Management and 
Budget (OMB) reviewed this ICR under emergency processing and approved 
the ICR on April 30, 2010. The CCIIO will be submitting a new ICR to 
OMB for review and approval in accordance with the Paperwork Reduction 
Act of 1995. The proposed information collection is published to obtain 
comments from the public and affected agencies.
    CCIIO is currently updating a system (hereon referred to as Web 
portal) where State Departments of Insurance and issuers will log in to 
using a custom user ID and password validation. The

[[Page 13417]]

States will be tasked to provide information on issuers in their State 
and various Web sites maintained for consumers. The issuers will be 
tasked to provide information on their major medical insurance products 
and plans. They will ultimately be given the choice to download a basic 
information template to enter data then upload into the Web portal; to 
manually enter data within the Web portal itself; or to submit xml 
files containing their information. Once the States and issuers submit 
their data, they will receive an e-mail notifying them of any errors, 
and that their submission was received.
    CCIIO is mandating the issuers verify and update their information 
on a quarterly basis and is requesting the States to verify State 
submitted information on an annual basis. In the event that an issuer 
enhances its existing plans, proposes new plans, or deactivates plans, 
the organization would be required to update the information in the Web 
portal. Changes occurring during the three month quarterly periods will 
be allowed utilizing effective dates for both the plans and rates 
associated with the plans. Information that is to be collected from 
State high risk pools will be collected from The National Association 
of State Comprehensive Health Insurance Plans (NASCHIP) at this time. 
Updates to this information may be submitted voluntarily.
    The estimated hour burden on issuers for the Plan Finder data 
collection in the first year is estimated as 84,600 total burden hours, 
or 113 hours per organization. This estimate is based on an assumed 
average of 450 individual plan issuers and 700 small group plan issuers 
per each of the four quarterly collections. It includes 30 hours per 
organization for training and communication. Additionally, for each of 
the issuers it includes 10 hours of preparation time, one hour of login 
and upload time, two hours of troubleshooting and data review and one 
half hour for attestation per organization per quarterly refresh.
    The estimated hour burden on the States is informed by the fact 
that they have already submitted the data once and only need to update. 
The overall hours estimate is 575, or 11.5 per Department of Insurance. 
This is premised on 2 hours of training and communication, 8 hours for 
data collection, and one half hour of submission. Form Number: CMS-
10320 (OMB: 0938-1086); Frequency: Reporting--Annually/
Quarterly; Affected Public: Business or other for-profits and States; 
Number of Respondents: 801; Total Annual Responses: 3,051; Total Annual 
Hours: 85,175. (For policy questions regarding this collection contact 
Beth Liu at 301-492-4268. For all other issues call 410-786-1326.)
    6. Type of Information Collection Request: New collection; Title of 
Information Collection: Version 5010/ICD-10 Industry Readiness 
Assessment Use: The Health Insurance Portability and Accountability Act 
of 1996 (HIPAA) requires the Secretary of HHS to adopt transaction 
standards that covered entities are required to use when electronically 
conducting certain health care administrative transactions, such as 
claims, remittance, eligibility and claims status requests and 
responses. Accordingly, on January 16, 2009, HHS published final rules 
adopting by regulation two sets of standards for HIPAA transactions: 
Version 5010 standards for eight types of electronic health care 
transactions (claims, eligibility inquiries, remittance advices, etc.) 
and ICD-10 code set standards. The final rules set compliance dates of 
January 1, 2012 for Version 5010 standards and October 1, 2013 for ICD-
10 standards. HIPAA transactions not meeting the standards by those 
dates will be rejected. The final rules also outlined interim 
milestones that organizations should meet in order to achieve 
compliance by the required dates. For Version 5010, these interim 
milestones include completing internal testing and being able to send 
and receive compliant transactions by December 2010, commencing 
external testing with trading partners by January 2011, and completing 
that testing and moving into production by the compliance date of 
January 1, 2012. Entities cannot implement ICD-10 standards until they 
are in compliance with Version 5010; the interim milestone for ICD-10 
is to begin compliance activities (gap analysis, design, development, 
internal testing) by January 2011.
    CMS has developed an education and communication campaign to 
support the adoption of and transition to Version 5010 and ICD-10. The 
education and communication activities will be targeted towards the 
millions of professionals across the health care industry who must take 
steps to prepare for the implementation of the new codes and 
transaction standards. CMS is requesting Office of Management and 
Budget (OMB) approval to conduct survey research to monitor the health 
care industry's awareness of, and preparation for, the transition to 
Version 5010 and ICD-10. The aggregated data obtained through the 
survey will help inform CMS outreach and education efforts to help 
affected entities (health care providers, health plans, clearinghouses, 
and then vendors who service them) meet interim milestones and achieve 
timely compliance so that they can continue to process HIPAA 
transactions without interruption.
    CMS has contracted to conduct a tracking survey of populations 
charged with implementing Version 5010 and ICD-10 electronic 
transaction processing, specifically payers (health insurance plans and 
managed care organizations), providers (hospitals and primary care 
providers), and vendors (software providers, third-party billers and 
clearinghouses). A self-administered Web-based survey will be the data 
collection. The data collection field period is expected to be four 
weeks in Summer 2011. Form Number: CMS-10381 (OMB: 0938-NEW); 
Frequency: Once; Affected Public: Business or other for-profits and 
Not-for-profit institutions; Number of Respondents: 600; Total Annual 
Responses: 600; Total Annual Hours: 150. (For policy questions 
regarding this collection contact Rosali Topper at 410-786-7260. For 
all other issues call 410-786-1326.)
    7. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Medicare Durable 
Medical Equipment Supplier Enrollment Application Use: The primary 
function of the CMS 855S DMEPOS supplier enrollment application is to 
gather information from a supplier that tells us who it is, whether it 
meets certain qualifications to be a health care supplier, where it 
renders its services or supplies, the identity of the owners of the 
enrolling entity, and information necessary to establish the correct 
claims payment. The goal of evaluating and revising the CMS 855S DMEPOS 
supplier enrollment application is to simplify and clarify the 
information collection without jeopardizing our need to collect 
specific information. Additionally, periodic revisions are necessary to 
incorporate new regulatory requirements. The goal of this revision of 
the CMS 855S is to incorporate new regulatory provisions found at 42 
CFR 424.57(c) (1 through 30) and 42 CFR 424.58. These revisions will 
allow CMS to be in compliance with the above stated regulations 
implementing new quality standards for DMEPOS suppliers, including 
accreditation requirements. This revision will also incorporate new 
supplier standard regulations found in the final regulation that 
published on August 27, 2010 (75 FR 52629-52649). Form Number: CMS-
855(S) (OMB: 0938-1056); Frequency:

[[Page 13418]]

Yearly; Affected Public: Private Sector; Business or other for-profit 
and not-for-profit institutions; Number of Respondents: 140,290; Total 
Annual Responses: 140,290; Total Annual Hours: (For policy questions 
regarding this collection contact Kim McPhillips at 410-786-5374. For 
all other issues call 410-786-1326.)
    8. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Medicare 
Enrollment Application Use: The primary function of the CMS-855 
Medicare enrollment application is to gather information from a 
provider or supplier that tells us who it is, whether it meets certain 
qualifications to be a health care provider or supplier, where it 
practices or renders its services, the identity of the owners of the 
enrolling entity, and other information necessary to establish correct 
claims payments. The goal of this submission is to address the 
following issues. The CMS-855A enrollment form currently captures 
ownership/managerial information on providers. The data required under 
sections 6401 and 6001, however, is more specific than that currently 
obtained on the CMS-855A. CMS will therefore create four attachments to 
the CMS-855A--two for SNFs and the other two for physician-owned 
hospitals--to secure this information. In addition to the application 
changes triggered by ACA, CMS is making other revisions to the forms as 
well. Form Number: CMS-855 (A, B, I, R) (OMB: 0938-0685); 
Frequency: Yearly; Affected Public: Private Sector; Business or other 
for-profit and not-for-profit institutions; Number of Respondents: 
440,450; Total Annual Responses: 440,450; Total Annual Hours: 842,810 
(For policy questions regarding this collection contact Kim McPhillips 
at 410-786-5374. For all other issues call 410-786-1326.)
    9. Type of Information Collection Request: New collection; Title of 
Information Collection: Medicare Enrollment Application for Eligible 
Ordering and Referring Physicians and Non-physician Practices Use: CMS 
is adding a new CMS-855 Medicare Enrollment Application (CMS 855O--
Medicare Enrollment Application for Ordering and Referring Physicians 
only). CMS has found that many providers and suppliers who are not 
enrolled in Medicare are ordering and referring physicians for Medicare 
enrolled providers and suppliers. The ordering and referring data field 
on the CMS 1500 claims submission form requires an ordering or 
referring physician to have a Medicare identification number. Without 
an ordering or referring physician, specific types of claims submitted 
by Medicare approved providers and suppliers are rejected by Medicare 
Administrative Contractors (MAC) as required by Medicare regulation. 
Therefore, if an ordering or referring physician does not participate 
in the Medicare program, but orders or refers his/her patients to a 
Medicare provider or supplier, the claim submitted by the Medicare 
provider or supplier for the given ordered or referred service is 
automatically rejected by the MAC. The CMS 855O allows a physician to 
receive a Medicare identification number (without being approved for 
billing privileges) for the sole purpose of ordering and referring 
beneficiaries to Medicare approved providers and suppliers. This new 
Medicare application form allows physicians who do not provide services 
to Medicare beneficiaries to be given a Medicare identification number 
without having to supply all the data required for the submission of 
Medicare claims. It also allows the Medicare program to identify 
ordering and referring physicians without having to validate the amount 
of data necessary to determine claims payment eligibility (such as 
banking information), while continuing to identify the physician's 
credentials as valid for ordering and referring purposes. Form Number: 
CMS-855(O) (OMB: 0938-NEW0685); Frequency: Yearly; Affected 
Public: Private Sector; Business or other for-profit and not-for-profit 
institutions; Number of Respondents: 48,000; Total Annual Responses: 
48,000; Total Annual Hours: 46,000 (For policy questions regarding this 
collection contact Kim McPhillips at 410-786-5374. 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 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 10, 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 4, 2011.
Martique Jones,
Director, Regulations Development Group, Division B, Office of 
Strategic Operations and Regulatory Affairs.
[FR Doc. 2011-5684 Filed 3-10-11; 8:45 am]
BILLING CODE 4120-01-P