81 FR 42710 - Agency Information Collection Activities: Proposed Collection; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 81, Issue 126 (June 30, 2016)
Centers for Medicare & Medicaid Services
Federal Register Volume 81, Issue 126 (June 30, 2016)
| Page Range | 42710-42711 | |
| FR Document | 2016-15564 |
[Federal Register Volume 81, Number 126 (Thursday, June 30, 2016)] [Notices] [Pages 42710-42711] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-15564] [[Page 42710]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifiers: CMS-10260, CMS-10305 and CMS-10622] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Centers for Medicare & Medicaid Services. 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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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 must be received by August 29, 2016. ADDRESSES: When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways: 1. Electronically. You may send 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) that are 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. 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: Contents This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see ADDRESSES). CMS-10260 Medicare Advantage and Prescription Drug Program: Final Marketing Provisions in 42 CFR 422.111(a)(3) and 423.128(a)(3) CMS-10305 Medicare Part C and Part D Data Validation (42 CFR 422.516(g) and 423.514(g)) CMS-10622 Evaluation of the CMS Quality Improvement Organizations: Reducing Healthcare-Acquired Conditions in Nursing Homes Under the 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 requires federal agencies to publish a 60-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. Information Collection 1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Medicare Advantage and Prescription Drug Program: Final Marketing Provisions in 42 CFR 422.111(a)(3) and 423.128(a)(3); Use: We require that Medicare Advantage (MA) organizations and Part D sponsors use standardized documents to satisfy disclosure requirements mandated by section 1851 (d)(3)(A) of the Social Security Act (Act) and 42 CFR 422.111(b) for MA organizations, and section 1860D-1(c) of the Act and 42 CFR 423.128(a)(3) for Part D sponsors. The regulatory provisions require that MA organizations and Part D sponsors disclose plan information, including: Service area, benefits, access, grievance and appeals procedures, and quality improvement and quality assurance requirements by September 30th of each year. The MA organizations and Part D sponsors use the information to comply with the disclosure requirements. We will use the approved standardized documents to ensure that correct information is disclosed to current and potential enrollees. For 2017, CMS has a total of nine standardized ANOC/EOC documents: Health Maintenance Organization, Cost, Dual Eligible Special Needs, Medicare Medical Savings Account, Private-Fee-For-Service, Preferred Provider Organizations, Preferred Provider Organization with Prescription Drugs, Health Maintenance Organization with Prescription Drug, and Prescription Drug. These standardized documents will be used by MA organizations and Part D sponsors for the 2018 contract year. In revising the standardized ANOC/EOCs for contract year 2018, we did not add to or remove any section from the prior contract year ANOC/ EOC models. MA organizations and Part D sponsors are still required to use the standardized language in the ANOC/EOC models and to send this document to current members at least 15 days prior to the start of the annual enrollment period or by September 30, 2017 for the 2018 enrollment season, based on 42 CFR 422.111(a) (3) and 423.128(a)(3). Form Number: CMS-10260 (OMB control number: 0938-1051); Frequency: Yearly; Affected Public: Private sector (Business or other for- profits); Number of Respondents: 805; Total Annual Responses: 805; Total Annual Hours: 9,660. (For policy questions regarding this collection contact Gladys Valentin at 410-786-1620.) 2. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Medicare Part C and Part D Data Validation (42 CFR 422.516(g) and 423.514(g)); Use: Organizations contracted to offer [[Page 42711]] Medicare Part C and Part D benefits are required to report data to us on a variety of measures. For the data to be useful for monitoring and performance measurement, the data must be reliable, valid, complete, and comparable among sponsoring organizations. To meet this goal, we have developed reporting standards and data validation specifications with respect to the Part C and Part D reporting requirements. These standards provide a review process for Medicare Advantage Organizations, Cost Plans, and Part D sponsors to use to conduct data validation checks on their reported Part C and Part D data. The FDCF is revised for the 2017 and 2018 DV collection periods by changing the scoring of six standards from a binary scale to a five- point Likert-type scale. This change is expected to improve the precision of the data validation scores by increasing overall variation in total scores among the MAOs and PDPs. The revision is not expected to alter resource requirements, since the assessment by DV contractors in scoring standards will continue to be based on the percentage of records that meet the standards. Form Number: CMS-10305 (OMB control number: 0938-1115); Frequency: Yearly; Affected Public: Private sector--Business or other for-profits; Number of Respondents: 639; Total Annual Responses: 639; Total Annual Hours: 209,271. (For policy questions regarding this collection contact Terry Lied at 410-786- 8973.) 3. Type of Information Collection Request: Extension of a currently approved collection; 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. 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. 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: 242. (For policy questions regarding this collection contact Robert Kambic at 410-786- 1515.) Dated: June 27, 2016. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2016-15564 Filed 6-29-16; 8:45 am] BILLING CODE 4120-01-P
![42710 Federal Register / Vol. 81, No. 126 / Thursday, June 30, 2016 / Notices
DEPARTMENT OF HEALTH AND 05, 7500 Security Boulevard, Baltimore, Advantage and Prescription Drug
HUMAN SERVICES Maryland 21244–1850. Program: Final Marketing Provisions in
To obtain copies of a supporting 42 CFR 422.111(a)(3) and 423.128(a)(3);
Centers for Medicare & Medicaid statement and any related forms for the Use: We require that Medicare
Services proposed collection(s) summarized in Advantage (MA) organizations and Part
[Document Identifiers: CMS–10260, CMS–
this notice, you may make your request D sponsors use standardized documents
10305 and CMS–10622] using one of following: to satisfy disclosure requirements
1. Access CMS’ Web site address at mandated by section 1851 (d)(3)(A) of
Agency Information Collection http://www.cms.hhs.gov/ the Social Security Act (Act) and 42
Activities: Proposed Collection; PaperworkReductionActof1995. CFR 422.111(b) for MA organizations,
Comment Request 2. Email your request, including your and section 1860D–1(c) of the Act and
address, phone number, OMB number, 42 CFR 423.128(a)(3) for Part D
AGENCY: Centers for Medicare & and CMS document identifier, to sponsors. The regulatory provisions
Medicaid Services. Paperwork@cms.hhs.gov. require that MA organizations and Part
ACTION: Notice. 3. Call the Reports Clearance Office at D sponsors disclose plan information,
(410) 786–1326. including: Service area, benefits, access,
SUMMARY: The Centers for Medicare & FOR FURTHER INFORMATION CONTACT: grievance and appeals procedures, and
Medicaid Services (CMS) is announcing Reports Clearance Office at (410) 786– quality improvement and quality
an opportunity for the public to 1326. assurance requirements by September
comment on CMS’ intention to collect 30th of each year. The MA organizations
information from the public. Under the SUPPLEMENTARY INFORMATION:
and Part D sponsors use the information
Paperwork Reduction Act of 1995 (the Contents to comply with the disclosure
PRA), federal agencies are required to requirements. We will use the approved
publish notice in the Federal Register This notice sets out a summary of the
use and burden associated with the standardized documents to ensure that
concerning each proposed collection of correct information is disclosed to
information (including each proposed following information collections. More
detailed information can be found in current and potential enrollees.
extension or reinstatement of an existing For 2017, CMS has a total of nine
collection of information) and to allow each collection’s supporting statement
standardized ANOC/EOC documents:
60 days for public comment on the and associated materials (see
Health Maintenance Organization, Cost,
ADDRESSES).
proposed action. Interested persons are Dual Eligible Special Needs, Medicare
invited to send comments regarding our CMS–10260 Medicare Advantage and Medical Savings Account, Private-Fee-
burden estimates or any other aspect of Prescription Drug Program: Final For-Service, Preferred Provider
this collection of information, including Marketing Provisions in 42 CFR Organizations, Preferred Provider
any of the following subjects: (1) The 422.111(a)(3) and 423.128(a)(3) Organization with Prescription Drugs,
necessity and utility of the proposed CMS–10305 Medicare Part C and Part Health Maintenance Organization with
information collection for the proper D Data Validation (42 CFR 422.516(g) Prescription Drug, and Prescription
performance of the agency’s functions; and 423.514(g)) Drug. These standardized documents
(2) the accuracy of the estimated CMS–10622 Evaluation of the CMS will be used by MA organizations and
burden; (3) ways to enhance the quality, Quality Improvement Organizations: Part D sponsors for the 2018 contract
utility, and clarity of the information to Reducing Healthcare-Acquired year.
be collected; and (4) the use of Conditions in Nursing Homes In revising the standardized ANOC/
automated collection techniques or Under the PRA (44 U.S.C. 3501– EOCs for contract year 2018, we did not
other forms of information technology to 3520), federal agencies must obtain add to or remove any section from the
minimize the information collection approval from the Office of Management prior contract year ANOC/EOC models.
burden. and Budget (OMB) for each collection of MA organizations and Part D sponsors
information they conduct or sponsor. are still required to use the standardized
DATES: Comments must be received by The term ‘‘collection of information’’ is language in the ANOC/EOC models and
August 29, 2016. defined in 44 U.S.C. 3502(3) and 5 CFR to send this document to current
ADDRESSES: When commenting, please 1320.3(c) and includes agency requests members at least 15 days prior to the
reference the document identifier or or requirements that members of the start of the annual enrollment period or
OMB control number. To be assured public submit reports, keep records, or by September 30, 2017 for the 2018
consideration, comments and provide information to a third party. enrollment season, based on 42 CFR
recommendations must be submitted in Section 3506(c)(2)(A) of the PRA 422.111(a) (3) and 423.128(a)(3). Form
any one of the following ways: requires federal agencies to publish a Number: CMS–10260 (OMB control
1. Electronically. You may send your 60-day notice in the Federal Register number: 0938–1051); Frequency: Yearly;
comments electronically to http:// concerning each proposed collection of Affected Public: Private sector (Business
www.regulations.gov. Follow the information, including each proposed or other for-profits); Number of
instructions for ‘‘Comment or extension or reinstatement of an existing Respondents: 805; Total Annual
Submission’’ or ‘‘More Search Options’’ collection of information, before Responses: 805; Total Annual Hours:
to find the information collection submitting the collection to OMB for 9,660. (For policy questions regarding
document(s) that are accepting approval. To comply with this this collection contact Gladys Valentin
comments. at 410–786–1620.)
mstockstill on DSK3G9T082PROD with NOTICES
requirement, CMS is publishing this
2. By regular mail. You may mail notice. 2. Type of Information Collection
written comments to the following Request: Revision of a currently
address: CMS, Office of Strategic Information Collection approved collection; Title of
Operations and Regulatory Affairs, 1. Type of Information Collection Information Collection: Medicare Part C
Division of Regulations Development, Request: Revision of a currently and Part D Data Validation (42 CFR
Attention: Document Identifier/OMB approved collection; Title of 422.516(g) and 423.514(g)); Use:
Control Number lll, Room C4–26– Information Collection: Medicare Organizations contracted to offer
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![Federal Register / Vol. 81, No. 126 / Thursday, June 30, 2016 / Notices 42711
Medicare Part C and Part D benefits are an independent and objective program during the annual CMS Quality
required to report data to us on a variety evaluation of the 11th SOW. Evaluation conference. The purpose of the
of measures. For the data to be useful for activities will focus on analyzing how interviews and focus groups is to
monitoring and performance well the QIO program is achieving the examine: (i) QIO processes for recruiting
measurement, the data must be reliable, three aims of better care, better health, nursing homes, peer coaches, and
valid, complete, and comparable among and lower cost as well as the beneficiaries to participate in the
sponsoring organizations. To meet this effectiveness of the new QIO program program; (ii) strengths and challenges of
goal, we have developed reporting structure. One of the QIN–QIOs’ tasks to QIN–QIO activities related to nursing
standards and data validation achieve these three aims is to support homes; (iii) partnership and
specifications with respect to the Part C participating nursing homes in their coordination with other QIN–QIO tasks;
and Part D reporting requirements. efforts to improve quality of care and and (iv) overall lessons learned. We will
These standards provide a review health outcomes among residents. also conduct qualitative interviews with
process for Medicare Advantage According to the 2013 CMS Nursing nursing home peer coaches. Form
Organizations, Cost Plans, and Part D Home Data Compendium, more than Number: CMS–10622 (OMB control
sponsors to use to conduct data 15,000 nursing homes participated in number: 0938–NEW); Frequency:
validation checks on their reported Part Medicare and Medicaid programs with Annually; Affected Public: Business or
C and Part D data. more than 1.4 million beneficiaries other for-profits and Not-for Profits
The FDCF is revised for the 2017 and resided in U.S. nursing homes. These institutions; Number of Respondents:
2018 DV collection periods by changing residents and their families rely on 856; Total Annual Responses: 856; Total
the scoring of six standards from a nursing homes to provide reliable, safe, Annual Hours: 242. (For policy
binary scale to a five-point Likert-type high quality care. However, cognitive questions regarding this collection
scale. This change is expected to and functional impairments, pain, contact Robert Kambic at 410–786–
improve the precision of the data incontinence, antipsychotic drug use, 1515.)
validation scores by increasing overall and healthcare associated conditions Dated: June 27, 2016.
variation in total scores among the (HAC), such as pressure ulcers and falls, William N. Parham, III,
MAOs and PDPs. The revision is not remain areas of concern.
Director, Paperwork Reduction Staff, Office
expected to alter resource requirements, This information collection is to of Strategic Operations and Regulatory
since the assessment by DV contractors provide data to assess QIN–QIOs efforts Affairs.
in scoring standards will continue to be aimed at addressing these HACs in
[FR Doc. 2016–15564 Filed 6–29–16; 8:45 am]
based on the percentage of records that nursing homes. QIN–QIOs are
BILLING CODE 4120–01–P
meet the standards. Form Number: responsible for recruiting nursing homes
CMS–10305 (OMB control number: to participate in the program. We will
0938–1115); Frequency: Yearly; Affected conduct an annual survey of DEPARTMENT OF HEALTH AND
Public: Private sector—Business or other administrators of nursing homes HUMAN SERVICES
for-profits; Number of Respondents: participating in the QIN–QIO program
639; Total Annual Responses: 639; Total (intervention group) and administrators Centers for Medicare & Medicaid
Annual Hours: 209,271. (For policy at nursing homes that are not Services
questions regarding this collection participating in the QIN–QIO program
contact Terry Lied at 410–786–8973.) (comparison group). Our proposed [Document Identifier: CMS–10316 and CMS–
3. Type of Information Collection 10545]
survey assesses progress towards the
Request: Extension of a currently goals of the QIN–QIO SOW, including Agency Information Collection
approved collection; Title of activities and strategies to increase Activities: Submission for OMB
Information Collection: Evaluation of mobility among residents, reduce Review; Comment Request
the CMS Quality Improvement infections, reduce use of inappropriate
Organizations: Reducing Healthcare- antipsychotic medication among long- ACTION: Notice.
Acquired Conditions in Nursing Homes; term stay residents.
Use: As mandated by Sections 1152– We plan to conduct qualitative SUMMARY: The Centers for Medicare &
1154 of the Social Security Act, CMS interviews with nursing home Medicaid Services (CMS) is announcing
directs the QIO program, one of the administrators. This interview will an opportunity for the public to
largest federal programs dedicated to supplement the Nursing Home Survey comment on CMS’ intention to collect
improving health quality for Medicare and provide more in-depth contextual information from the public. Under the
beneficiaries. In the 11th SOW, CMS information about the QIN–QIO Paperwork Reduction Act of 1995
restructured the QIO program to funded program implementation within at (PRA), federal agencies are required to
Quality Innovation Networks (QIN)– nursing homes, including: (i) Their publish a notice in the Federal Register
QIOs, Beneficiary and Family-Centered experience with, and perceived success concerning each proposed collection of
Care (BFCC) organizations, National of QIN–QIO collaboratives; (ii) their information, including each proposed
Coordinating Centers (NCCs), Program satisfaction with the QIN–QIO extension or reinstatement of an existing
Collaboration Centers (PCCs), and the Collaborative and QIO support; (iii) collection of information, and to allow
Strategic Innovation Engine (SIE). In the perceived value and impact of QIO a second opportunity for public
current SOW, 14 QIN–QIOs coordinate program; and (iv) drivers and barriers to comment on the notice. Interested
the work of 53 QIOs nationwide QIN–QIO involvement and success. persons are invited to send comments
including all 50 states and other U.S. Information from QIO leadership and/ regarding the burden estimate or any
mstockstill on DSK3G9T082PROD with NOTICES
territories. or state/territory task leads will be other aspect of this collection of
CMS evaluates the quality and collected by interviews and focus information, including any of the
effectiveness of the QIO program as groups. Interviews with Nursing Home following subjects: (1) The necessity and
authorized in Part B of Title XI of the Task leaders at the QIN and QIO will be utility of the proposed information
Social Security Act. CMS created the conducted in-person during site visits collection for the proper performance of
Independent Evaluation Center (IEC) to and/or over the phone. We will conduct the agency’s functions; (2) the accuracy
provide CMS and its stakeholders with focus groups with QIO-level Directors of the estimated burden; (3) ways to
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Document Created: 2018-02-08 07:45:24
Document Modified: 2018-02-08 07:45:24
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments must be received by August 29, 2016. | |
| Contact | Reports Clearance Office at (410) 786- 1326. | |
| FR Citation | 81 FR 42710 |
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