Agency Information Collection Activities: Proposed Collection; Comment Request, 53060-53061 [2021-20727]

Download as PDF 53060 Federal Register / Vol. 86, No. 183 / Friday, September 24, 2021 / Notices under Section 1862(a)(1)(A) of the ACT. Furthermore, data from the Registry will assist the medical device industry and the Food and Drug Administration (FDA) in surveillance of the quality, safety and efficacy of new medical devices to treat MR. Form Number: CMS–10531 (OMB control number: 0938–1274); Frequency: Annually; Affected Public: Private sector (Business or other for-profits); Number of Respondents: 8,649; Total Annual Responses: 34,596; Total Annual Hours: 12,974. (For policy questions regarding this collection contact Sarah Fulton at 410–786–2749.) 2. Title of Information Collection: Healthcare Fraud Prevention Partnership (HFPP) Data Sharing and Information Exchange; Type of Information Collection Request: Revision; Use: Section 1128C(a)(2) of the Social Security Act (42 U.S.C. 1320a–7c(a)(2)) authorizes the Secretary and the Attorney General to consult, and arrange for the sharing of data with, representatives of health plans for purposes of establishing a Fraud and Abuse Control Program as specified in Section 1128(C)(a)(1) of the Social Security Act. The result of this authority has been the establishment of the HFPP. The HFPP was officially established by a Charter in the fall of 2012 and signed by HHS Secretary Sibelius and US Attorney General Holder. In December 2020, President Trump signed into law H.R.133—Consolidated Appropriations Act, 2021, which amended Section 1128C(a) of the Social Security Act (42 U.S.C. 1320a–7c(a)) providing explicit statutory authority for the Healthcare Fraud Prevention Partnership including the potential expansion of the publicprivate partnership analyses. Data sharing within the HFPP primarily focuses on conducting studies for the purpose of combatting fraud, waste, and abuse. These studies are intended to target specific vulnerabilities within the payment systems in both the public and private healthcare sectors. The HFPP and its committees design and develop studies in coordination with the TTP. The core function of the TTP is to manage and execute the HFPP studies within the HFPP. Form Number: CMS–10501 (OMB control number: 0938–1251); Frequency: Occasionally; Affected Public: Private sector (Business or other for-profits); Number of Respondents: 28; Number of Responses: 28; Total Annual Hours: 120. (For questions regarding this collection, contact Marnie Dorsey at (410–786–5942). VerDate Sep<11>2014 16:50 Sep 23, 2021 Jkt 253001 Dated: September 21, 2021. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2021–20722 Filed 9–23–21; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifiers: CMS–10786 and CMS–R–153] Agency Information Collection Activities: Proposed Collection; Comment Request Centers for Medicare & Medicaid Services, Health and Human Services (HHS). ACTION: Notice. AGENCY: 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 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 minimize the information collection burden. DATES: Comments must be received by November 23, 2021. 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. SUMMARY: PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 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: ll, 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’ website address at https://www.cms.gov/Regulations-andGuidance/Legislation/Paperwork ReductionActof1995/PRA-Listing.html. FOR FURTHER INFORMATION CONTACT: William N. Parham at (410) 786–4669. 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–10786 Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act Section 1003 Demonstration Evaluation CMS–R–153 Medicaid Drug Use Review (DUR) Program 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: New collection (Request for a new OMB Control Number); Title of Information Collection: Substance UseDisorder Prevention that Promotes Opioid Recovery and Treatment E:\FR\FM\24SEN1.SGM 24SEN1 Federal Register / Vol. 86, No. 183 / Friday, September 24, 2021 / Notices (SUPPORT) for Patients and Communities Act Section 1003 Demonstration Evaluation; Use: Section 1003 of the SUPPORT Act authorizes the Secretary of HHS, in consultation with the Director of the Agency for Healthcare Research and Quality (AHRQ) and the Assistant Secretary for Mental Health and Substance Use from the Substance Abuse and Mental Health Services Administration (SAMHSA), to conduct a 54-month demonstration project (hereinafter, ‘‘the Demonstration’’) which is designed to increase the capacity of Medicaid providers to deliver substance use disorder (SUD) treatment and recovery services. Section 1003 also requires an evaluation of the demonstration. The evaluation is designed to assess: • The effectiveness of the Demonstration in increasing the capacity of providers participating under the Medicaid state plan (or a waiver of such plan) to provide substance use disorder treatment or recovery services under such plan (or waiver); • The activities carried out under the planning grants and demonstration project; • The extent to which participating states have achieved the stated goals; and • The strengths and limitations of the planning grants and demonstration project. This collection of information request is intended to satisfy the reporting requirements, defined in the statute, regarding the impact of the Demonstration. The evaluation of the Demonstration will assess the extent to which the participating states achieved the goals they established to increase substance use treatment or recovery provider capacity under the Medicaid program. This includes both the planning and post-planning periods of the demonstration, as evaluation during both phases will enable CMS and stakeholders to assess the effects of the additional support provided to states during the post-planning period, relative to the planning period only. Primary data collection will occur in two rounds in year two and year four of the evaluation. In both rounds, data collection will consist of: (1) A survey of providers in all 15 Planning Grant states who are eligible to prescribe and/ or administer either buprenorphine or methadone medication for opioid use disorder (OUD), and (2) focus groups of providers in five post-planning period states (two focus groups per state, with six to eight participants in each group) who treat SUD, including OUD. VerDate Sep<11>2014 16:50 Sep 23, 2021 Jkt 253001 The survey will gather information on provider experiences related to Medicaid provider enrollment, SUD service delivery, and changes in OUD medication treatment, including barriers and enablers of prescribing and dispensing. The focus groups will examine the impact of key aspects of implementation, such as perceived burdens associated with Medicaid enrollment or MAT delivery, access to referral placements, value of stateprovided TA, and benefits and unanticipated outcomes experienced by providers during the Demonstration. Form Number: CMS–10786 (OMB control number: 0938–NEW); Frequency: Biennial; Affected Public: Private sector (Business or other forprofits and Not-for-profit institutions); Number of Respondents: 28,810; Total Annual Responses: 14,405; Total Annual Hours: 3,689. (For policy questions regarding this collection contact Melanie Brown at 410–786– 1095.) 2. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Medicaid Drug Use Review (DUR) Program; Use: States must provide for a review of drug therapy before each prescription is filled or delivered to a Medicaid patient. This review includes screening for potential drug therapy problems due to therapeutic duplication, drug-disease contraindications, drug-drug interactions, incorrect drug dosage or duration of drug treatment, drug-allergy interactions, and clinical abuse/misuse. Pharmacists must make a reasonable effort to obtain, record, and maintain Medicaid patient profiles. These profiles must reflect at least the patient’s name, address, telephone number, date of birth/age, gender, history, e.g., allergies, drug reactions, list of medications, and pharmacist’s comments relevant to the individual’s drug therapy. The States must conduct RetroDUR which provides for the ongoing periodic examination of claims data and other records in order to identify patterns of fraud, abuse, inappropriate or medically unnecessary care. Patterns or trends of drug therapy problems are identified and reviewed to determine the need for intervention activity with pharmacists and/or physicians. States may conduct interventions via telephone, correspondence, or face-to-face contact. Annual reports are submitted to CMS for the purposes of monitoring compliance and evaluating the progress of States’ DUR programs. The information submitted by States is reviewed and results are compiled by PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 53061 CMS in a format intended to provide information, comparisons, and trends related to States’ experiences with DUR. States benefit from the information and may enhance their programs each year based on State reported innovative practices that are compiled by CMS from the DUR annual reports. In this 2021 collection of information request, we revised certain FFS, MCO, and Abbreviated MCO survey questions. While a few questions were added to the surveys to address GAO (U.S. Government Accountability Office) recommendations, other aspects of the survey changes include grammar and formatting edits. Overall, we are not revising our currently approved burden estimates. Form Number: CMS–R–153 (OMB control number: 0938–0659); Frequency: Yearly, quarterly, and occasionally; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 51; Total Annual Responses: 663; Total Annual Hours: 41,004. (For policy questions regarding this collection contact Mike Forman at 410–786–2666.) Dated: September 21, 2021. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2021–20727 Filed 9–23–21; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Mother and Infant Home Visiting Program Evaluation (MIHOPE): Long-Term Follow-Up, Kindergarten Data Collection (MIHOPE–K) (OMB #0970–0402) Office of Planning, Research, and Evaluation, Administration for Children and Families, HHS. ACTION: Request for public comment. AGENCY: The Administration for Children and Families (ACF), in partnership with the Health Resources and Services Administration (HRSA), both of the U.S. Department of Health and Human Services (HHS), is proposing to extend data collection activity as part of the kindergarten phase of the Mother and Infant Home Visiting Program Evaluation Long-Term Follow-Up project (MIHOPE–K). The purpose of MIHOPE–K is to conduct a follow-up study that assesses the longterm impact of the Maternal, Infant, and SUMMARY: E:\FR\FM\24SEN1.SGM 24SEN1

Agencies

[Federal Register Volume 86, Number 183 (Friday, September 24, 2021)]
[Notices]
[Pages 53060-53061]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-20727]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10786 and CMS-R-153]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services, Health and Human 
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 (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 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 minimize the information collection 
burden.

DATES: Comments must be received by November 23, 2021.

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' website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.

FOR FURTHER INFORMATION CONTACT: William N. Parham at (410) 786-4669.

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-10786 Substance Use-Disorder Prevention that Promotes Opioid 
Recovery and Treatment (SUPPORT) for Patients and Communities Act 
Section 1003 Demonstration Evaluation
CMS-R-153 Medicaid Drug Use Review (DUR) Program

    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: New collection (Request 
for a new OMB Control Number); Title of Information Collection: 
Substance Use-Disorder Prevention that Promotes Opioid Recovery and 
Treatment

[[Page 53061]]

(SUPPORT) for Patients and Communities Act Section 1003 Demonstration 
Evaluation; Use: Section 1003 of the SUPPORT Act authorizes the 
Secretary of HHS, in consultation with the Director of the Agency for 
Healthcare Research and Quality (AHRQ) and the Assistant Secretary for 
Mental Health and Substance Use from the Substance Abuse and Mental 
Health Services Administration (SAMHSA), to conduct a 54-month 
demonstration project (hereinafter, ``the Demonstration'') which is 
designed to increase the capacity of Medicaid providers to deliver 
substance use disorder (SUD) treatment and recovery services.
    Section 1003 also requires an evaluation of the demonstration. The 
evaluation is designed to assess:
     The effectiveness of the Demonstration in increasing the 
capacity of providers participating under the Medicaid state plan (or a 
waiver of such plan) to provide substance use disorder treatment or 
recovery services under such plan (or waiver);
     The activities carried out under the planning grants and 
demonstration project;
     The extent to which participating states have achieved the 
stated goals; and
     The strengths and limitations of the planning grants and 
demonstration project.
    This collection of information request is intended to satisfy the 
reporting requirements, defined in the statute, regarding the impact of 
the Demonstration. The evaluation of the Demonstration will assess the 
extent to which the participating states achieved the goals they 
established to increase substance use treatment or recovery provider 
capacity under the Medicaid program. This includes both the planning 
and post-planning periods of the demonstration, as evaluation during 
both phases will enable CMS and stakeholders to assess the effects of 
the additional support provided to states during the post-planning 
period, relative to the planning period only.
    Primary data collection will occur in two rounds in year two and 
year four of the evaluation. In both rounds, data collection will 
consist of: (1) A survey of providers in all 15 Planning Grant states 
who are eligible to prescribe and/or administer either buprenorphine or 
methadone medication for opioid use disorder (OUD), and (2) focus 
groups of providers in five post-planning period states (two focus 
groups per state, with six to eight participants in each group) who 
treat SUD, including OUD.
    The survey will gather information on provider experiences related 
to Medicaid provider enrollment, SUD service delivery, and changes in 
OUD medication treatment, including barriers and enablers of 
prescribing and dispensing.
    The focus groups will examine the impact of key aspects of 
implementation, such as perceived burdens associated with Medicaid 
enrollment or MAT delivery, access to referral placements, value of 
state-provided TA, and benefits and unanticipated outcomes experienced 
by providers during the Demonstration.
    Form Number: CMS-10786 (OMB control number: 0938-NEW); Frequency: 
Biennial; Affected Public: Private sector (Business or other for-
profits and Not-for-profit institutions); Number of Respondents: 
28,810; Total Annual Responses: 14,405; Total Annual Hours: 3,689. (For 
policy questions regarding this collection contact Melanie Brown at 
410-786-1095.)
    2. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Medicaid Drug Use 
Review (DUR) Program; Use: States must provide for a review of drug 
therapy before each prescription is filled or delivered to a Medicaid 
patient. This review includes screening for potential drug therapy 
problems due to therapeutic duplication, drug-disease 
contraindications, drug-drug interactions, incorrect drug dosage or 
duration of drug treatment, drug-allergy interactions, and clinical 
abuse/misuse. Pharmacists must make a reasonable effort to obtain, 
record, and maintain Medicaid patient profiles. These profiles must 
reflect at least the patient's name, address, telephone number, date of 
birth/age, gender, history, e.g., allergies, drug reactions, list of 
medications, and pharmacist's comments relevant to the individual's 
drug therapy.
    The States must conduct RetroDUR which provides for the ongoing 
periodic examination of claims data and other records in order to 
identify patterns of fraud, abuse, inappropriate or medically 
unnecessary care. Patterns or trends of drug therapy problems are 
identified and reviewed to determine the need for intervention activity 
with pharmacists and/or physicians. States may conduct interventions 
via telephone, correspondence, or face-to-face contact.
    Annual reports are submitted to CMS for the purposes of monitoring 
compliance and evaluating the progress of States' DUR programs. The 
information submitted by States is reviewed and results are compiled by 
CMS in a format intended to provide information, comparisons, and 
trends related to States' experiences with DUR. States benefit from the 
information and may enhance their programs each year based on State 
reported innovative practices that are compiled by CMS from the DUR 
annual reports.
    In this 2021 collection of information request, we revised certain 
FFS, MCO, and Abbreviated MCO survey questions. While a few questions 
were added to the surveys to address GAO (U.S. Government 
Accountability Office) recommendations, other aspects of the survey 
changes include grammar and formatting edits. Overall, we are not 
revising our currently approved burden estimates.
    Form Number: CMS-R-153 (OMB control number: 0938-0659); Frequency: 
Yearly, quarterly, and occasionally; Affected Public: State, Local, or 
Tribal Governments; Number of Respondents: 51; Total Annual Responses: 
663; Total Annual Hours: 41,004. (For policy questions regarding this 
collection contact Mike Forman at 410-786-2666.)

    Dated: September 21, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2021-20727 Filed 9-23-21; 8:45 am]
BILLING CODE 4120-01-P