[Federal Register Volume 79, Number 124 (Friday, June 27, 2014)]
[Notices]
[Pages 36518-36521]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-15073]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-370 and CMS-377, CMS 437, CMS-10510, CMS-216-
94, CMS-10494, CMS-10224, CMS-10472 and CMS-10499]


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is 
announcing an opportunity for the public to comment on CMS' intention 
to collect information from the public. Under the Paperwork Reduction 
Act of 1995 (PRA), federal agencies are required to publish notice in 
the Federal Register concerning each proposed collection of 
information, including each proposed extension or reinstatement of an 
existing collection of information, and to allow a second opportunity 
for public comment on the notice. Interested persons are invited to 
send comments regarding the 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.

DATES: Comments on the collection(s) of information must be received by 
the OMB desk officer by July 28, 2014.

ADDRESSES: When commenting on the proposed information collections, 
please reference the document identifier or OMB control number. To be 
assured consideration, comments and recommendations must be received by 
the OMB desk officer via one of the following transmissions: OMB, 
Office of Information and Regulatory Affairs, Attention: CMS Desk 
Officer, Fax Number: (202) 395-5806 or, Email: [email protected]. To obtain copies of a supporting statement and 
any related forms for the proposed collection(s) summarized in this 
notice, you may make your request using one of following:
    1. Access CMS' Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995.
    2. Email your request, including your address, phone number, OMB 
number, and CMS document identifier, to [email protected].
    3. Call the Reports Clearance Office at (410) 786-1326.

FOR FURTHER INFORMATION CONTACT: Reports Clearance Office at (410) 786-
1326.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. The term ``collection of 
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and 
includes agency requests or requirements that members of the public 
submit reports, keep records, or provide information to a third party. 
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires 
federal agencies to publish a 30-day notice in the Federal Register 
concerning each proposed collection of information, including each 
proposed extension or reinstatement of an existing collection of 
information, before submitting the collection to OMB for approval. To 
comply with this requirement, CMS is publishing this notice that 
summarizes the following proposed collection(s) of information for 
public comment:

[[Page 36519]]

    1. Type of Information Collection Request: Revision of a currently 
approved collection; Titles of Information Collection: Health Insurance 
Benefits Agreement and Ambulatory Surgical Request for Certification or 
Update of Certification Information in the Medicare Program; Use: The 
CMS-370 is used to establish eligibility for payment. This agreement, 
upon submission by the ambulatory surgical center (ASC) and acceptance 
for filing by the Secretary of Health & Human Services, shall be 
binding on both the ASC and the Secretary. The agreement may be 
terminated by either party in accordance with regulations. In the event 
of termination, payment will not be available for ASC services 
furnished on or after the effective date of termination. The CMS-377 is 
used to collect facility-specific characteristics that facilitate CMS' 
oversight of ambulatory surgical centers. The CMS-377 is submitted by 
ASCs when they request initial certification of compliance with the ASC 
conditions for coverage or to update an ASC's existing certification 
information. It is also used by State agencies who conduct 
certification surveys on CMS' behalf to maintain information on the 
facility's characteristics that facilitate conducting surveys, e.g., 
determining the size and the composition of the survey team on the 
basis of the number of operating and procedure rooms and the types of 
surgical procedures performed in the ASC.
    Form Numbers: CMS-370 and CMS-377 (OMB control number: 0938-0266); 
Frequency: Occasionally; Affected Public: Private Sector--Business or 
other for-profit and Not-for-profit institutions; Number of 
Respondents: 5,449; Total Annual Responses: 1,833; Total Annual Hours: 
633. (For policy questions regarding this collection contact Erin McCoy 
at 410-786-2337.)
    2. Type of Information Collection Request: Reinstatement with 
Change of a currently approved collection; Title of Information 
Collection: Psychiatric Unit Criteria Work Sheet and Supporting 
Regulations; Use: Certain hospital units are excluded from the Medicare 
Prospective Payment System (PPS). The exclusion of units is not 
optional on the part of the provider but is required by section 
1886(d)(1)(B) of the Social Security Act. That section excludes 
psychiatric hospitals, rehabilitation hospitals, hospitals whose 
inpatients are predominantly individuals under 18 years of age 
(children's hospitals), and psychiatric and rehabilitation units which 
are a distinct part of a hospital. We propose to continue the current 
process of performing initial verifications and annual re-verifications 
to determine that psychiatric units continue to comply with the 
regulatory criteria at 42 CFR 412.25 and 42 CFR 412.27 of the PPS 
regulations. These regulations state the criteria that distinct part 
units must meet for exclusion.
    If, as a result of the regular survey process a hospital is 
certified as a psychiatric hospital by the State survey agency (SA), 
then it automatically satisfies the regulatory criteria for exclusion. 
Thus, no additional verification is required for psychiatric hospitals. 
Some verification is needed, however, to ensure that other types of 
hospitals and units meet the criteria for exclusion. Consequently, we 
instructed the Medicare Administrative Contractors (MACs) (formerly 
known as FIs) and SAs to perform certain verification activities, 
beginning in October 1983 when PPS was implemented. We originally 
developed the CMS-437 as an SA Worksheet for verifying exclusions from 
PPS for psychiatric units.
    Since April 9, 1994, PPS-excluded psychiatric units already 
excluded from the PPS have met our annual requirement for PPS-exclusion 
by self-attesting that they remain in compliance with the PPS exclusion 
criteria. Under the current procedure, all psychiatric units applying 
for first-time exclusion are surveyed by the SAs. The SAs also perform 
surveys to investigate complaint allegations and conduct annual sample 
re-verification surveys on 5 percent of all psychiatric units. The 
aforementioned exclusions continue to exist and thus we propose to 
continue to use the Criteria Worksheet, Forms CMS-437, for verifying 
first-time exclusions from the PPS, for complaint surveys, for its 
annual 5 percent validation sample, and for facility self-attestation. 
These forms are related to the survey and certification and Medicare 
approval of the PPS-excluded units.
    Form Number: CMS-437 (OMB control number: 0938-0358); Frequency: 
Annually; Affected Public: Private sector--Business or other for-
profits; Number of Respondents: 1,614; Total Annual Responses: 1,614; 
Total Annual Hours: 404. (For policy questions regarding this 
collection contact Donald Howard at 410-786-6764.)
    3. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Basic Health 
Program Report for Health Insurance Exchange Premium; Use: The Basic 
Health Program (BHP) is federally funded by determining the amount of 
payments that the federal government would have made through the 
premium tax credit (PTC) and cost sharing reductions (CSR) for people 
enrolled in BHP had they instead been enrolled in an Exchange. To 
calculate the amounts for each state, we need the reference premiums 
for the second lowest cost silver plans (SLCSP) in each geographic area 
in a state, as SLCSPs are a basic unit in the calculation of PTC and 
CSRs under the Exchanges. To estimate what PTC and CSRs would have been 
paid, the reference premiums for these SLCSPs are critical components 
in the BHP payment methodology. Similarly, we also need to collect 
reference premiums for the lowest cost bronze plans to appropriately 
account for CSR calculations for American Indians and Alaskan Natives. 
Reference premiums are foundational inputs into the BHP payment 
methodology. We have the necessary information to determine these 
reference premiums for states with Exchanges operated by the Federally 
Facilitated Exchange (FFE) or are operated in partnership with the FFE. 
Consequently, this collection only pertains to the 17 states that are 
operating State Based Exchanges.
    Form Number: CMS-10510 (OMB control number: 0938-1218); Frequency: 
Yearly; Affected Public: State, Local, or Tribal Governments; Number of 
Respondents: 17; Total Annual Responses: 17; Total Annual Hours: 68. 
(For policy questions regarding this collection contact Carey Appold at 
410-786-2117).
    4. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Organ Procurement 
Organization/Histocompatibility Laboratory Cost Report; Use: We are 
requesting an extension of the Form CMS 216-94, Organ Procurement 
Organization (OPO)/Histocompatibility Laboratory Cost Report. These 
cost reports are filed annually by freestanding OPO and 
Histocompatibility Lab providers participating in the Medicare program 
to determine the reasonable costs incurred to furnish treatment for 
renal transplant patients. Form Number: CMS-216-94 (OMB control number: 
0938-0102); Frequency: Annually; Affected Public: Private sector--
Business or other for-profits; Number of Respondents: 107; Total Annual 
Responses: 107 Total Annual Hours: 4,815. (For policy questions 
regarding this collection contact Angela Havrilla at 410-786-4516.)
    5. Type of Information Collection Request: Revision of a previously 
approved information collection; Title of Information Collection: 
Consumer

[[Page 36520]]

Assistance Tools and Programs of an Exchange and Certified Application 
Counselors; Exchange and Insurance Market Standards for 2015; Use: 
Section 1321(a)(1) of the Affordable Care Act directs and authorizes 
the Secretary to issue regulations setting standards for meeting the 
requirements under title I of the Affordable Care Act, with respect to, 
among other things, the establishment and operation of Exchanges. 
Pursuant to this authority, regulations establishing the certified 
application counselor program are being finalized at 45 CFR 155.225. 
Specifically, 45 CFR 155.225(a) requires an Exchange to establish a 
certified application counselor program that complies with the 
requirements of the rule. Section 155.225(b)(1) allows each Exchange to 
designate certain organizations, including organizations designated by 
state Medicaid or CHIP agencies, which will certify their staff and 
volunteers to act as certified application counselors. In accordance 
with 45 CFR 155.225(b)(2), Exchanges may choose to certify directly 
individuals who seek to act as certified application counselors, 
designate certain organizations which will certify staff or volunteers 
to perform application services, or do both. In accordance with 
155.225(d)(7), certified application counselors in all Exchanges are 
required to be recertified on at least an annual basis and successfully 
complete Exchange-required recertification training.
    Form Number: CMS-10494 (OMB control number: 0938-1205); Frequency: 
On Occasion; Affected Public: State, Local, or Tribal Governments, 
Private Sector: not-for-profit institutions; individuals or households; 
Number of Respondents: 35,000; Number of Responses: 160,000; Total 
Annual Hours: 19,610. (For policy questions regarding this collection, 
contact Tricia Beckmann at 301-492-4328.)
    6. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Healthcare Common 
Procedure Coding System (HCPCS)--Level II Code Modification Request 
Process; Use: Each year in the United States healthcare insurers 
process over 5 billion claims for payment. For Medicare and other 
health insurance programs to ensure that these claims are processed in 
an orderly and consistent manner, standardized coding systems are 
essential. The Healthcare Common Procedure Coding System (HCPCS) Level 
II Code Set is one of the standard code sets used for this purpose. 
Level II of the HCPCS, also referred to as alpha-numeric codes, is a 
standardized coding system that is used primarily to identify products, 
supplies, and services not included in the CPT codes, such as 
ambulatory services and durable medical equipment, prosthetics, 
orthotics, and supplies (DMEPOS) when used in the home or outpatient 
setting.
    The HCPCS codeset has been maintained and distributed via 
modifications of codes, modifiers and descriptions, as a direct result 
of data received from applicants. The HCPCS codeset maintenance is an 
ongoing process, as changes are implemented and updated annually; 
therefore, the process requires continual collection of information 
from applicants on an annual basis. As new technology evolves and new 
devices, drugs and supplies are introduced to the market, applicants 
submit applications to us requesting modifications to the HCPCS Level 
II codeset.
    Form Number: CMS-10224 (OMB control number: 0938-1042); Frequency: 
Annually; Affected Public: Private sector--Business or other for-
profits and Not-for-profit institutions; Number of Respondents: 300; 
Total Annual Responses: 300 Total Annual Hours: 3,300. (For policy 
questions regarding this collection contact Kimberlee Combs Miller at 
410-786-6707.)
    7. Type of Information Collection Request: Revision of a previously 
approved information collection; Title of Information Collection: 
Exchange Functions: Standards for Navigators and Non-Navigator 
Assistance Personnel; Use: Section 1321(a)(1) of the Affordable Care 
Act directs and authorizes the Secretary to issue regulations setting 
standards for meeting the requirements under title I of the Affordable 
Care Act, with respect to, among other things, the establishment and 
operation of Exchanges. Pursuant to this authority, regulations have 
been finalized at 45 CFR 155.210(e)(6) and 45 CFR 155.215(g) to require 
Navigators, as well as those non-Navigator personnel to whom 45 CFR 
155.215 applies, to inform consumers of the functions and 
responsibilities of Navigators and non-Navigator assistance personnel 
(as applicable) and obtain authorization for the disclosure of consumer 
information to the Navigator or non-Navigator assistance personnel 
prior to obtaining the consumer's personally identifiable information. 
Navigators and non-Navigator assistance personnel to whom 45 CFR 
155.215 applies are also required to maintain a record of the 
authorization provided in a form and manner as determined by the 
Exchange.
    Form Number: CMS-10472 (OMB control number. 0938-1220); Frequency: 
On Occasion; Affected Public: State, Local, or Tribal Governments, 
Private Sector (not-for-profit institutions); individuals or 
households; Number of Respondents: 5,610; Number of Responses: 5,610; 
Total Annual Hours: 35,709. (For policy questions regarding this 
collection, contact Emily Ames at 301-492-4246.)
    8. Type of Information Collection Request: New collection (Request 
for a new OMB control number); Title of Information Collection: Public 
Health Agency/Registry Readiness to Support Meaningful Use; Use: The 
Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs 
provide incentives for the meaningful use of Certified Electronic 
Health Record Technology (CEHRT). We defined meaningful use as a set of 
objectives and measures in either Stage 1 or Stage 2 depending on how 
long an eligible provider has participated in the program. Both Stage 1 
(3 objectives) and Stage 2 (5 objectives) of meaningful use contain 
objectives and measures that require eligible providers to determine 
the readiness of public health agencies and registries to receive 
electronic data from CEHRT. Public comments on the notice of proposed 
rulemaking for Stage 2 of meaningful use (77 FR 13697) asserted that 
the burden for each individual eligible provider to determine the 
readiness of multiple public health agencies and registries could be 
nearly eliminated if we were to maintain a database on the readiness of 
public health agencies and registries. In the final rule for Stage 2 of 
meaningful use (77 FR 53967), we agreed that the burden on eligible 
providers, public health agencies and registries would be greatly 
reduced and established that we would create such a database and it 
would serve as the definitive information source for determining public 
health agency and registry readiness to receive electronic data 
associated with the public health meaningful use objectives. The 
information will be made publicly available on the CMS Web site 
(www.cms.gov/EHRincentiveprograms) in order to provide a centralized 
repository of this information to eligible providers and eliminate 
there multiple individual inquiries to multiple public health agencies 
and registries. Form Number: CMS-10499 (OMB control number: 0938-New); 
Frequency: Yearly; Affected Public: Private sector--Business or other 
for-profits and Not-for-profit institutions; Number of Respondents: 
250; Total Annual Responses: 250; Total Annual Hours: 83. (For policy 
questions regarding this collection contact Kathleen Connors de Laguna 
at 410-786-2256.


[[Page 36521]]


    Dated: June 24, 2014.
Martique Jones,
Deputy Director, Regulations Development Group, Office of Strategic 
Operations and Regulatory Affairs.
[FR Doc. 2014-15073 Filed 6-26-14; 8:45 am]
BILLING CODE 4120-01-P