[Federal Register Volume 81, Number 210 (Monday, October 31, 2016)]
[Notices]
[Pages 75409-75411]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-26242]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10622, CMS-339, CMS-460, CMS-R-64, CMS-379, 
CMS-10311, CMS-1490, CMS-10137, and CMS-10237]


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

AGENCY: Centers for Medicare & Medicaid Services, HHS.

ACTION: Notice.

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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 November 30, 2016.

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:
    1. Type of Information Collection Request: New collection (Request 
for a new OMB control number); Title of Information Collection: 
Evaluation of the CMS Quality Improvement Organizations: Reducing 
Healthcare-Acquired Conditions in Nursing Homes; Use: As mandated by 
Sections 1152-1154 of the Social Security Act, CMS directs the QIO 
program, one of the largest federal programs dedicated to improving 
health quality for Medicare beneficiaries. In the 11th SOW, CMS 
restructured the QIO program to funded Quality Innovation Networks 
(QIN)-QIOs, Beneficiary and Family-Centered Care (BFCC) organizations, 
National Coordinating Centers (NCCs), Program Collaboration Centers 
(PCCs), and the Strategic Innovation Engine (SIE). In the current SOW, 
14 QIN-QIOs coordinate the work of 53 QIOs nationwide including all 50 
states and other U.S. territories.
    CMS evaluates the quality and effectiveness of the QIO program as 
authorized in Part B of Title XI of the Social Security Act. CMS 
created the Independent Evaluation Center (IEC) to provide CMS and its 
stakeholders with an independent and objective program evaluation of 
the 11th SOW. Evaluation activities will focus on analyzing how well 
the QIO program is achieving the three aims of better care, better 
health, and lower cost as well as the effectiveness of the new QIO 
program structure. One of the QIN-QIOs' tasks to achieve these three 
aims is to support participating nursing homes in their efforts to 
improve quality of care and health outcomes among residents. According 
to the 2013 CMS Nursing Home Data Compendium, more than 15,000 nursing 
homes participated in Medicare and Medicaid programs with more than 1.4 
million beneficiaries resided in U.S. nursing homes. These residents 
and their families rely on nursing homes to provide reliable, safe, 
high quality care. However, cognitive and functional impairments, pain, 
incontinence, antipsychotic drug use, and healthcare associated 
conditions (HAC), such as pressure ulcers and falls, remain areas of 
concern.
    This information collection is to provide data to assess QIN-QIOs 
efforts aimed at addressing these HACs in nursing homes. QIN-QIOs are 
responsible for recruiting nursing homes to participate in the program. 
We will conduct an annual survey of administrators of nursing homes 
participating in the QIN-QIO program (intervention group) and 
administrators at nursing homes that are not participating in the QIN-
QIO program (comparison group). Our proposed survey assesses progress 
towards the goals of the QIN-QIO SOW, including activities and 
strategies to increase mobility among residents, reduce infections, 
reduce use of inappropriate antipsychotic medication among long-term 
stay residents.
    We plan to conduct qualitative interviews with nursing home 
administrators. This interview will supplement the Nursing Home Survey 
and provide more in-depth contextual information about the QIN-QIO 
program implementation within at nursing homes, including: (i) Their 
experience with, and perceived success of QIN-QIO collaboratives; (ii) 
their satisfaction with the QIN-QIO Collaborative and QIO support; 
(iii) perceived value and impact of QIO program; and (iv) drivers and 
barriers to QIN-QIO involvement and success.

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    Information from QIO leadership and/or state/territory task leads 
will be collected by interviews and focus groups. Interviews with 
Nursing Home Task leaders at the QIN and QIO will be conducted in-
person during site visits and/or over the phone. We will conduct focus 
groups with QIO-level Directors during the annual CMS Quality 
conference. The purpose of the interviews and focus groups is to 
examine: (i) QIO processes for recruiting nursing homes, peer coaches, 
and beneficiaries to participate in the program; (ii) strengths and 
challenges of QIN-QIO activities related to nursing homes; (iii) 
partnership and coordination with other QIN-QIO tasks; and (iv) overall 
lessons learned. We will also conduct qualitative interviews with 
nursing home peer coaches. Subsequent to the 60-day notice Federal 
Register notice, the survey has been revised by adding questions and 
rewording questions. Form Number: CMS-10622 (OMB control number: 0938-
NEW); Frequency: Annually; Affected Public: Business or other For-
profits and Not-for Profits institutions; Number of Respondents: 856; 
Total Annual Responses: 856; Total Annual Hours: 255. (For policy 
questions regarding this collection contact Robert Kambic at 410-786-
1515.)
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Provider Cost 
Report Reimbursement Questionnaire; Use: The information collected in 
this form (Exhibits 1 and 2) is authorized under Sections 1815(a) and 
1833(e) of the Social Security Act, 42 U.S.C. 1395g. Regulations at 42 
CFR 413.20 and 413.24 require providers to submit financial and 
statistical records to verify the cost data disclosed on their annual 
Medicare cost report. Providers participating in the Medicare program 
are reimbursed for furnishing covered services to eligible 
beneficiaries on the basis of an annual cost report (filed with the 
provider's MAC) in which the proper reimbursement is computed. 
Consequently, it is necessary to collect this documentation of 
providers' costs and activities that supports the Medicare cost report 
data in order to ensure proper Medicare reimbursement to providers. 
Form Number: CMS-339 (OMB control number: 0938-0301); Frequency: 
Yearly; Affected Public: Private sector (Business or other For-
profits); Number of Respondents: 2,273; Total Annual Responses: 2,273; 
Total Annual Hours: 15,911. (For policy questions regarding this 
collection contact Christine Dobrzycki at 410-786-3389.)
    3. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Medicare 
Participation Agreement for Physicians and Suppliers; Use: Section 
1842(h) of the Social Security Act permits physicians and suppliers to 
voluntarily participate in Medicare Part B by agreeing to take 
assignment on all claims for services to Medicare beneficiaries. The 
law also requires that the Secretary provide specific benefits to the 
physicians, suppliers and other persons who choose to participate. The 
CMS-460 is the agreement by which the physician or supplier elects to 
participate in Medicare. Form Number: CMS-460 (OMB control number: 
0938-0373); Frequency: Yearly; Affected Public: Private sector 
(Business or other For-profits); Number of Respondents: 120,000; Total 
Annual Responses: 120,000; Total Annual Hours: 30,000. (For policy 
questions regarding this collection contact Mark Baldwin at 410-786-
8139.)
    4. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Indirect Medical 
Education and Supporting Regulations; Use: Section 1886(d)(5)(B) of the 
Social Security Act requires additional payments to be made under the 
Medicare Prospective Payment System (PPS) for the indirect medical 
educational costs a hospital incurs in connection with interns and 
residents (IRs) in approved teaching programs. In addition, Title 42, 
Part 413, sections 75 through 83 implement section 1886(d) of the Act 
by establishing the methodology for Medicare payment of the cost of 
direct graduate medical educational activities. These payments, which 
are adjustments (add-ons) to other payments made to a hospital under 
PPS, are largely determined by the number of full-time equivalent (FTE) 
IRs that work at a hospital during its cost reporting period. In 
Federal fiscal year (FY) 2015, the estimated Medicare program payments 
for indirect medical education (IME) costs amounted to $8.38 billion. 
Medicare program payments for direct graduate medical education (GME) 
are also based upon the number of FTE-IRs that work at a hospital. In 
FY 2015, the estimated Medicare program payments for GME costs amounted 
to $3.1 billion. Form Number: CMS-R-64 (OMB control number: 0938-0456); 
Frequency: Yearly; Affected Public: Private sector (Business or other 
For-profits); Number of Respondents: 1,245; Total Annual Responses: 
1,245; Total Annual Hours: 2,490. (For policy questions regarding this 
collection contact Milton Jacobson at 410-786-7553.)
    5. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Financial 
Statement of Debtor; Use: Section 1893(f)(1)) of the Social Security 
Act and 42 CFR 401.607 provides the authority for collection of this 
information. Section 42 CFR 405.607 requires that, CMS recover amounts 
of claims due from debtors including interest where appropriate by 
direct collections in lump sums or in installments. In addition, the 
DOJ Final Rule, the Federal Claims Collection Standards, which was 
published as 32 CFR parts 900-904, on November 22, 2000, in the Federal 
Register, Section 32 CFR 900.1 stipulates that, standards for Federal 
agency use in the administrative collection, offset, compromise, and 
the suspension or termination of collection activity. Section 32 CFR 
901.8(a) states that, Agencies should obtain financial statements from 
debtors who represent that they are unable to pay the debt in one lump 
sum. Form Number: CMS-379 (OMB control number: 0938-0270); Frequency: 
Yearly; Affected Public: Business or other for-profits; Number of 
Respondents: 500; Total Annual Responses: 500; Total Annual Hours: 
1,000. (For policy questions regarding this collection contact Anita 
Crosier at 410-786-0217.)
    6. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Medicare Program/
Home Health Prospective Payment System Rate Update for Calendar Year 
2010: Physician Narrative Requirement and Supporting Regulation; Use: 
Section (o) of the Act (42 U.S.C. 1395 x) specifies certain 
requirements that a home health agency must meet to participate in the 
Medicare program. To qualify for Medicare coverage of home health 
services a Medicare beneficiary must meet each of the following 
requirements as stipulated in Sec.  409.42: be confined to the home or 
an institution that is not a hospital, SNF, or nursing facility as 
defined in sections 1861(e)(1), 1819(a)(1) or 1919 of Act; be under the 
care of a physician as described in Sec.  409.42(b); be under a plan of 
care that meets the requirements specified in Sec.  409.43; the care 
must be furnished by or under arrangements made by a participating HHA, 
and the beneficiary must be in need of skilled services as described in 
Sec.  409.42(c). Subsection 409.42(c) of our regulations

[[Page 75411]]

requires that the beneficiary need at least one of the following 
services as certified by a physician in accordance with Sec.  424.22: 
Intermittent skilled nursing services and the need for skilled services 
which meet the criteria in Sec.  409.32; Physical therapy which meets 
the requirements of Sec.  409.44(c), Speech-language pathology which 
meets the requirements of Sec.  409.44(c); or have a continuing need 
for occupational therapy that meets the requirements of Sec.  
409.44(c), subject to the limitations described in Sec.  409.42(c)(4). 
On March 23, 2010, the Affordable Care Act of 2010 (Pub. L., 111-148) 
was enacted. Section 6407(a) (amended by section 10605) of the 
Affordable Care Act amends the requirements for physician certification 
of home health services contained in Sections 1814(a)(2)(C) and 
1835(a)(2)(A) by requiring that, prior to certifying a patient as 
eligible for Medicare's home health benefit, the physician must 
document that the physician himself or herself or a permitted non-
physician practitioner has had a face-to-face encounter (including 
through the use of tele-health services, subject to the requirements in 
section 1834(m) of the Act)'', with the patient. The Affordable Care 
Act provision does not amend the statutory requirement that a physician 
must certify a patient's eligibility for Medicare's home health 
benefit, (see Sections 1814(a)(2)(C) and 1835(a)(2)(A) of the Act. Form 
Number: CMS-10311 (OMB control number: 0938-1083); Frequency: Yearly; 
Affected Public: Business or other For-profits; Number of Respondents: 
345,600; Total Annual Responses: 345,600; Total Annual Hours: 28,800. 
(For policy questions regarding this collection contact Hillary 
Loeffler at 410-786-0456.)
    7. Type of Information Collection Request: New collection (Request 
for a new OMB control number); Title of Information Collection: 
Patient's Request for Medicare Payment; Use: The Form CMS-1490S form 
provides beneficiaries with a relatively easy form to use when filing 
their claims. Without the collection of this information, claims for 
reimbursement relating to the provision of Part B medical services/
supplies could not be acted upon. This would result in a nationwide 
paralysis of the operation of the Federal Government's Part B Medicare 
program, and major problems for the patients/beneficiaries inflicting 
severe physical and financial hardship on beneficiaries. This form was 
explicitly developed for easy use by beneficiaries who file their own 
claims. The CMS-1490S form can be obtained from any Social Security 
office or Medicare Administrative Contractors or CMS. When the CMS-
1490S is used, the beneficiary must attach to it his/her bills from 
physicians or suppliers. The form is, therefore, designed specifically 
to aid beneficiaries who cannot get assistance from their physicians or 
suppliers for completing claim forms. The form is currently approved 
under 0938-1197; however, we are submitting for approval as a 
standalone information collection request. Once a new OMB control 
number is issued, we will remove the burden for the CMS-1490S that is 
currently approved under OMB control number 0938-1197. Form Number: 
CMS-1490 (OMB control number: 0938-NEW); Frequency: Occasionally 
Affected Public: Individuals and Households; Number of Respondents: 
167,839; Total Annual Responses: 167,839; Total Annual Hours: 83,920. 
(For policy questions regarding this collection contact Sumita Sen at 
410-786-5755.)
    8. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Solicitation for 
Applications for Medicare Prescription Drug Plan 2018 Contracts; Use: 
Coverage for the prescription drug benefit is provided through 
contracted prescription drug (PD) plans 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 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 application. Form Number: CMS-
10137 (OMB control number: 0938-0936); Frequency: Yearly; Affected 
Public: Private sector (Business or other For-profits and Not-for-
profit institutions); Number of Respondents: 463; Total Annual 
Responses: 160; Total Annual Hours: 1,565. (For policy questions 
regarding this collection contact Arianne Spaccarelli at 410-786-5715.)
    9. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Applications for 
Part C Medicare Advantage, 1876 Cost Plans, and Employer Group Waiver 
Plans to Provide Part C Benefits; Use: This information collection 
includes the process for organizations wishing to provide healthcare 
services under MA and/or MA-PD plans must complete an application 
annually, file a bid, and receive final approval from CMS. The 
application process has two options for applicants that include: 
Request for new MA product or request for expanding the service area of 
an existing product. This collection process is the only mechanism for 
MA and/or MA-PD organizations to complete the required application 
process. CMS utilizes the application process as the means to review, 
assess and determine if applicants are compliant with the current 
requirements for participation in the Medicare Advantage program and to 
make a decision related to contract award. Form Number: CMS-10237 (OMB 
control number: 0938-0935); Frequency: Yearly; Affected Public: Private 
sector (Business or other For-profits and Not-for-profit institutions); 
Number of Respondents: 310; Total Annual Responses: 310; Total Annual 
Hours: 10,941. (For policy questions regarding this collection contact 
Marcella Watts at 410-786-5724.)

    Dated: October 26, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2016-26242 Filed 10-28-16; 8:45 am]
BILLING CODE 4120-01-P