81 FR 76946 - Agency Information Collection Activities: Submission for OMB Review; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 81, Issue 214 (November 4, 2016)
Centers for Medicare & Medicaid Services
Federal Register Volume 81, Issue 214 (November 4, 2016)
| Page Range | 76946-76947 | |
| FR Document | 2016-26743 |
[Federal Register Volume 81, Number 214 (Friday, November 4, 2016)] [Notices] [Pages 76946-76947] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-26743] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifiers: CMS-10191 and CMS-10305] Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY: Centers for Medicare & Medicaid Services, HHS. 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: The necessity and utility of the proposed information collection for the proper performance of the agency's functions; the accuracy of the estimated burden; ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to [[Page 76947]] minimize the information collection burden. DATES: Comments on the collection(s) of information must be received by the OMB desk officer by December 5, 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: Revision of a currently approved collection; Title of Information Collection: Medicare Parts C and D Program Audit Protocols and Data Requests; Use: Under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and implementing regulations at 42 CFR parts 422 and 423, Medicare Part D plan sponsors and Medicare Advantage organizations are required to comply with all Medicare Parts C and D program requirements. In 2010, the explosive growth of these sponsoring organizations forced CMS to develop an audit strategy to ensure we continue to obtain meaningful audit results. As a result, CMS' audit strategy reflected a move to a more targeted, data-driven and risk-based audit approach. We focused on high-risk areas that have the greatest potential for beneficiary harm. To maximize resources, CMS will focus on assisting the industry to improve their operations to ensure beneficiaries receive access to care. One way to accomplish this is CMS will develop an annual audit strategy which describes how sponsors will be selected for audit and the areas that will be audited. CMS has developed several audit protocols and these are posted to the CMS Web site each year for use by sponsors to prepare for their audit. Currently CMS utilizes the following 7 protocols to audit sponsor performance: Formulary Administration (FA), Coverage Determinations, Appeals & Grievances (CDAG), Organization Determination, Appeals and Grievances (ODAG), Special Needs Model of Care (SNPMOC) (only administered on organizations who operate SNPs), Compliance Program Effectiveness (CPE), Medication Therapy Management (MTM) and Provider Network Accuracy (PNA). The data collected is detailed in each of these protocols and the exact fields are located in the record layouts, at the end of each protocol. In addition, questionnaires are distributed as part of our CDAG, ODAG and CPE audits. These questionnaires are also included in this package. As part of a robust audit process, CMS also requires sponsors who have been audited and found to have deficiencies to undergo a validation audit to ensure correction. The validation audit utilizes the same audit protocols, but only tests the elements where deficiencies were found, as opposed to re-administering the entire audit. Finally, to assist in improving the audit process, CMS sends sponsors a link to a survey (Appendix D) at the end of each audit to complete in order to obtain the sponsors' feedback. The sponsor is not required to complete the survey. Form Number: CMS-10191 (OMB control number: 0938-1000); Frequency: Yearly; Affected Public: Private Sector (business or other for-profit and not-for-profit institutions); Number of Respondents: 40; Total Annual Responses: 40; Total Annual Hours: 13,640. (For policy questions regarding this collection contact Dawn Johnson at 410-786-3159.) 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 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.) Dated: November 1, 2016. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2016-26743 Filed 11-3-16; 8:45 am] BILLING CODE 4120-01-P
![76946 Federal Register / Vol. 81, No. 214 / Friday, November 4, 2016 / Notices
submitting the collection to OMB for 18,284. (For policy questions regarding network review during any of the
approval. To comply with this this collection contact Jacqueline Leach triggering events listed on page one, the
requirement, CMS is publishing this at 410–786–4282.) three-year anniversary date for that
notice. 3. Type of Information Collection contract will be reset, and CMS will
Request: New collection (Request for a maintain an HPMS report to keep track
Information Collection
new OMB control number); Title of of this date for every active network-
1. Type of Information Collection Information Collection: Three-Year based contract. Form Number: CMS–
Request: Revision of a currently Network Adequacy Review for Medicare 10636 (OMB control number 0938-
approved collection; Title of Advantage Organizations; Use: The CMS New); Frequency: Yearly; Affected
Information Collection: ICF/IID Survey Public: Private sector (Business or other
regulations at 42 CFR 422.112(a)(1)(i)
Report Form and Supporting for-profits); Number of Respondents:
and § 422.114(a)(3)(ii) require that all
Regulations; Use: The information 484; Total Annual Responses: 1,652;
Medicare Advantage organizations
collected with forms 3070G–I is used to Total Annual Hours: 15,692. (For policy
(MAOs) offering coordinated care plans
determine the level of compliance with questions regarding this collection
(e.g., HMO, PPO) or other network-
Intermediate Care Facilities for contact Theresa Wachter at 410–786–
based plans (e.g., network-based PFFS,
Individuals with Intellectual Disabilities 1157.)
network-based MSA, section 1876 cost
(ICF/IID) CoPs necessary to participate
plan) maintain a network of appropriate Dated: November 1, 2016.
in the Medicare/Medicaid program.
providers that is sufficient to provide William N. Parham, III,
Information needed to monitor the
State’s performance as well as the ICF/ adequate access to covered services to Director, Paperwork Reduction Staff, Office
IID program in general, is available to meet the needs of the population served. of Strategic Operations and Regulatory
CMS only through the use of To enforce this requirement, CMS has Affairs.
information abstracted from the survey developed network adequacy criteria, [FR Doc. 2016–26745 Filed 11–3–16; 8:45 am]
report form. The form serves as a coding which sets forth the minimum number BILLING CODE 4120–01–P
worksheet designed to facilitate data of providers and maximum travel time
entry and retrieval into the Automated and distance from enrollees to
Survey Processing Environment Suite providers, for each provider specialty DEPARTMENT OF HEALTH AND
(ASPEN) in the State and at the CMS type in each county in the United States HUMAN SERVICES
regional offices. Form Number: CMS– and its territories. MAOs must be in
3070G–I (OMB Control Number: 0938– compliance with the current CMS Centers for Medicare & Medicaid
0062); Frequency: Reporting—Yearly; network adequacy criteria. This Services
Affected Public: Private Sector: Business proposed collection of information is
essential to appropriate and timely [Document Identifiers: CMS–10191 and
or other for-profits and Not-for-profit CMS–10305]
institutions; Number of Respondents: compliance monitoring by CMS, in
6,310; Total Annual Responses: 6,310; order to ensure that all active MAO
Agency Information Collection
Total Annual Hours: 18,930. (For policy contracts offering network-based plans
Activities: Submission for OMB
questions regarding this collection maintain an adequate network.
Review; Comment Request
contact Melissa Rice at 410–786–3270.) Currently, CMS verifies that MAOs are
2. Type of Information Collection compliant with the current CMS AGENCY: Centers for Medicare &
Request: Revision of a currently network adequacy criteria by Medicaid Services, HHS.
approved collection; Title of performing a contract-level network ACTION: Notice.
Information Collection: Conditions for review, which occurs when CMS
Certification for Rural Health Clinics; requests that an MAO upload provider SUMMARY: The Centers for Medicare &
Use: The Rural Health Clinic (RHC) and facility Health Service Delivery Medicaid Services (CMS) is announcing
conditions of certification are based on (HSD) tables for a given contract to the an opportunity for the public to
criteria prescribed in law and are Health Plan Management System comment on CMS’ intention to collect
designed to ensure that each facility has (HPMS). If an MAO does not have its information from the public. Under the
a properly trained staff to provide contract-level network formally Paperwork Reduction Act of 1995
appropriate care and to assure a safe reviewed by CMS after the initial (PRA), federal agencies are required to
physical environment for patients. We contract application process, then there publish notice in the Federal Register
use these conditions of participation to is no CMS requirement for a network concerning each proposed collection of
certify RHCs wishing to participate in adequacy review unless one of the information, including each proposed
the Medicare program. These above listed triggering events occurs. extension or reinstatement of an existing
requirements are similar in intent to Therefore, CMS is proposing this collection of information, and to allow
standards developed by industry collection of information in order to a second opportunity for public
organizations such as the Joint improve monitoring of MAOs’ network comment on the notice. Interested
Commission on Accreditation of adequacy. This collection of information persons are invited to send comments
Hospitals, and the National League of requires the uploading of HSD tables to regarding the burden estimate or any
Nursing and the American Public the Network Management Module other aspect of this collection of
Association and merely reflect accepted (NMM) in HPMS for any contract that information, including any of the
standards of management and care to has not had an entire network review following subjects: The necessity and
asabaliauskas on DSK3SPTVN1PROD with NOTICES
which rural health clinics must adhere. performed by CMS in the previous three utility of the proposed information
Form Number: CMS–R–38 (OMB control years of contract operation. The collection for the proper performance of
number: 0938–0334); Frequency: collection process will occur at the the agency’s functions; the accuracy of
Recordkeeping and Reporting— contract level for each MAO that the estimated burden; ways to enhance
Annually; Affected Public: Business or qualifies, and CMS will assess each the quality, utility, and clarity of the
other for-profits; Number of contract against the current CMS information to be collected; and the use
Respondents: 4,247; Total Annual network adequacy criteria. Each time an of automated collection techniques or
Responses: 4,247; Total Annual Hours: MAO’s contract undergoes an entire other forms of information technology to
VerDate Sep<11>2014 17:52 Nov 03, 2016 Jkt 241001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\04NON1.SGM 04NON1](https://thefederalregister.org/doc/81_FR_77160/page/1.svg)
![Federal Register / Vol. 81, No. 214 / Friday, November 4, 2016 / Notices 76947
minimize the information collection Modernization Act of 2003 and Hours: 13,640. (For policy questions
burden. implementing regulations at 42 CFR regarding this collection contact Dawn
DATES: Comments on the collection(s) of parts 422 and 423, Medicare Part D plan Johnson at 410–786–3159.)
information must be received by the sponsors and Medicare Advantage 2. Type of Information Collection
OMB desk officer by December 5, 2016. organizations are required to comply
Request: Revision of a currently
with all Medicare Parts C and D
ADDRESSES: When commenting on the approved collection; Title of
program requirements. In 2010, the
proposed information collections, explosive growth of these sponsoring Information Collection: Medicare Part C
please reference the document identifier organizations forced CMS to develop an and Part D Data Validation (42 CFR
or OMB control number. To be assured audit strategy to ensure we continue to 422.516(g) and 423.514(g)); Use:
consideration, comments and obtain meaningful audit results. As a Organizations contracted to offer
recommendations must be received by result, CMS’ audit strategy reflected a Medicare Part C and Part D benefits are
the OMB desk officer via one of the move to a more targeted, data-driven required to report data to us on a variety
following transmissions: OMB, Office of and risk-based audit approach. We of measures. For the data to be useful for
Information and Regulatory Affairs, focused on high-risk areas that have the monitoring and performance
Attention: CMS Desk Officer, Fax greatest potential for beneficiary harm. measurement, the data must be reliable,
Number: (202) 395–5806 OR, Email: To maximize resources, CMS will valid, complete, and comparable among
OIRA_submission@omb.eop.gov. focus on assisting the industry to sponsoring organizations. To meet this
To obtain copies of a supporting improve their operations to ensure goal, we have developed reporting
statement and any related forms for the beneficiaries receive access to care. One standards and data validation
proposed collection(s) summarized in way to accomplish this is CMS will specifications with respect to the Part C
this notice, you may make your request develop an annual audit strategy which and Part D reporting requirements.
using one of following: describes how sponsors will be selected These standards provide a review
1. Access CMS’ Web site address at for audit and the areas that will be
http://www.cms.hhs.gov/ process for Medicare Advantage
audited. CMS has developed several
PaperworkReductionActof1995. Organizations, Cost Plans, and Part D
audit protocols and these are posted to
2. Email your request, including your the CMS Web site each year for use by sponsors to use to conduct data
address, phone number, OMB number, sponsors to prepare for their audit. validation checks on their reported Part
and CMS document identifier, to Currently CMS utilizes the following 7 C and Part D data.
Paperwork@cms.hhs.gov. protocols to audit sponsor performance: The FDCF is revised for the 2017 and
3. Call the Reports Clearance Office at Formulary Administration (FA), 2018 DV collection periods by changing
(410) 786–1326. Coverage Determinations, Appeals & the scoring of six standards from a
FOR FURTHER INFORMATION CONTACT: Grievances (CDAG), Organization binary scale to a five-point Likert-type
Reports Clearance Office at (410) 786– Determination, Appeals and Grievances scale. This change is expected to
1326. (ODAG), Special Needs Model of Care improve the precision of the data
(SNPMOC) (only administered on validation scores by increasing overall
SUPPLEMENTARY INFORMATION: Under the organizations who operate SNPs),
Paperwork Reduction Act of 1995 (PRA) variation in total scores among the
Compliance Program Effectiveness MAOs and PDPs. The revision is not
(44 U.S.C. 3501–3520), federal agencies (CPE), Medication Therapy Management
must obtain approval from the Office of expected to alter resource requirements,
(MTM) and Provider Network Accuracy
Management and Budget (OMB) for each since the assessment by DV contractors
(PNA). The data collected is detailed in
collection of information they conduct each of these protocols and the exact in scoring standards will continue to be
or sponsor. The term ‘‘collection of fields are located in the record layouts, based on the percentage of records that
information’’ is defined in 44 U.S.C. at the end of each protocol. In addition, meet the standards. Form Number:
3502(3) and 5 CFR 1320.3(c) and questionnaires are distributed as part of CMS–10305 (OMB control number:
includes agency requests or our CDAG, ODAG and CPE audits. 0938–1115); Frequency: Yearly; Affected
requirements that members of the public These questionnaires are also included Public: Private sector—Business or other
submit reports, keep records, or provide in this package. for-profits; Number of Respondents:
information to a third party. Section As part of a robust audit process, CMS 639; Total Annual Responses: 639; Total
3506(c)(2)(A) of the PRA (44 U.S.C. also requires sponsors who have been Annual Hours: 209,271. (For policy
3506(c)(2)(A)) requires federal agencies audited and found to have deficiencies questions regarding this collection
to publish a 30-day notice in the to undergo a validation audit to ensure contact Terry Lied at 410–786–8973.)
Federal Register concerning each correction. The validation audit utilizes
proposed collection of information, Dated: November 1, 2016.
the same audit protocols, but only tests
including each proposed extension or the elements where deficiencies were William N. Parham, III,
reinstatement of an existing collection found, as opposed to re-administering Director, Paperwork Reduction Staff, Office
of information, before submitting the the entire audit. Finally, to assist in of Strategic Operations and Regulatory
collection to OMB for approval. To improving the audit process, CMS sends Affairs.
comply with this requirement, CMS is sponsors a link to a survey (Appendix [FR Doc. 2016–26743 Filed 11–3–16; 8:45 am]
publishing this notice that summarizes D) at the end of each audit to complete BILLING CODE 4120–01–P
the following proposed collection(s) of in order to obtain the sponsors’
asabaliauskas on DSK3SPTVN1PROD with NOTICES
information for public comment: feedback. The sponsor is not required to
1. Type of Information Collection complete the survey. Form Number:
Request: Revision of a currently CMS–10191 (OMB control number:
approved collection; Title of 0938–1000); Frequency: Yearly; Affected
Information Collection: Medicare Parts Public: Private Sector (business or other
C and D Program Audit Protocols and for-profit and not-for-profit institutions);
Data Requests; Use: Under the Medicare Number of Respondents: 40; Total
Prescription Drug, Improvement, and Annual Responses: 40; Total Annual
VerDate Sep<11>2014 17:52 Nov 03, 2016 Jkt 241001 PO 00000 Frm 00037 Fmt 4703 Sfmt 9990 E:\FR\FM\04NON1.SGM 04NON1](https://thefederalregister.org/doc/81_FR_77160/page/2.svg)
Document Created: 2018-02-14 08:26:40
Document Modified: 2018-02-14 08:26:40
| 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 on the collection(s) of information must be received by the OMB desk officer by December 5, 2016. | |
| Contact | Reports Clearance Office at (410) 786- 1326. | |
| FR Citation | 81 FR 76946 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR