Agency Information Collection Activities: Proposed Collection; Comment Request, 68330-68332 [2020-23893]

Download as PDF jbell on DSKJLSW7X2PROD with NOTICES 68330 Federal Register / Vol. 85, No. 209 / Wednesday, October 28, 2020 / Notices Telephone: (513) 841–4515 (this is not a toll-free number); Email: TCarreonValencia@cdc.gov. SUPPLEMENTARY INFORMATION: Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to accomplishing the committee’s objectives. The Administrator of the WTC Health Program is seeking nominations for members fulfilling the following categories: • Occupational physician who has experience treating WTC rescue and recovery workers; • Environmental medicine/ environmental health professional; • Toxicologist; • Epidemiologist; • Occupational physician; • Representative of WTC responders; and • Representative of certified-eligible WTC survivors. Members may be invited to serve for four-year terms. Selection of members is based on candidates’ qualifications to contribute to the accomplishment of STAC objectives. More information on the committee is available at https:// www.cdc.gov/wtc/stac.html. The U.S. Department of Health and Human Services (HHS) policy stipulates that committee membership be balanced in terms of points of view represented, and the committee’s function. Appointments shall be made without discrimination on the basis of age, race, ethnicity, gender, sexual orientation, gender identity, HIV status, disability, and cultural, religious, or socioeconomic status. Nominees must be U.S. citizens. Current participation on federal workgroups or prior experience serving on a federal advisory committee does not disqualify a candidate; however, HHS policy is to avoid excessive individual service on advisory committees and multiple committee memberships. Committee members are Special Government Employees, requiring the filing of financial disclosure reports at the beginning and annually during their terms. NIOSH identifies potential candidates and provides a slate of nominees for consideration to the Director of CDC for STAC membership each year, CDC reviews the proposed slate of candidates, and provides a slate of nominees for consideration to the Secretary of HHS for final selection. HHS notifies selected candidates of their appointment near the start of the term in October, or as soon as the HHS selection process is completed. Note that the need for different expertise varies from year to year and a candidate VerDate Sep<11>2014 18:29 Oct 27, 2020 Jkt 253001 who is not selected in one year may be reconsidered in a subsequent year. Candidates should submit the following items: D Current curriculum vitae, including complete contact information (telephone numbers, mailing address, email address); D The category of membership (environmental medicine or environmental health specialist, occupational physician, pulmonary physician, representative of WTC responders, certified-eligible WTC survivor representative, industrial hygienist, toxicologist, epidemiologist, or mental health professional) that the candidate is qualified to represent); D A summary of the background, experience, and qualifications that demonstrates the candidate’s suitability for the nominated membership category; and D At least one letter of recommendation from person(s) not employed by the U.S. Department of Health and Human Services. (Candidates may submit letter(s) from current HHS employees if they wish, but at least one letter must be submitted by a person not employed by an HHS agency (e.g., CDC, NIH, FDA, etc.). Nominations may be submitted by the candidate him- or herself, or by the person/organization recommending the candidate. The Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Kalwant Smagh, Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention. [FR Doc. 2020–23803 Filed 10–27–20; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS–10307 and CMS– 10495] Agency Information Collection Activities: Proposed Collection; Comment Request Centers for Medicare & Medicaid Services, Health and Human Services (HHS). AGENCY: PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 ACTION: Notice. 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 December 28, 2020. 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 https:// 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 Numberlll, 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 website address at https://www.cms.gov/ Regulations-and-Guidance/Legislation/ PaperworkReductionActof1995/PRAListing.html. 2. Call the Reports Clearance Office at (410) 786–1326. FOR FURTHER INFORMATION CONTACT: William N. Parham at (410) 786–4669. SUMMARY: E:\FR\FM\28OCN1.SGM 28OCN1 Federal Register / Vol. 85, No. 209 / Wednesday, October 28, 2020 / Notices 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–10307 Medical Necessity and Claims Denial Disclosures under MHPAEA CMS–10495 Data Collection and Submission, Registration, Attestation, Dispute and Resolution, Record Retention, and Assumptions Document Submission, for Open Payments 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. jbell on DSKJLSW7X2PROD with NOTICES Information Collection 1. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Medical Necessity and Claims Denial Disclosures under MHPAEA; Use: The Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA) (P.L.110–343) generally requires that group health plans and group health insurance issuers offering mental health or substance use disorder (MH/SUD) benefits in addition to medical and surgical (med/surg) benefits ensure that they do not apply any more restrictive financial requirements (e.g., co-pays, deductibles) and/or treatment limitations (e.g., visit limits) to MH/SUD benefits than those requirements and/or limitations applied to substantially all med/surg benefits. The Patient Protection and Affordable Care Act, Public Law 111–148, was enacted on March 23, 2010, and the VerDate Sep<11>2014 18:29 Oct 27, 2020 Jkt 253001 Health Care and Education Reconciliation Act of 2010, Public Law 111–152, was enacted on March 30, 2010, collectively known as the ‘‘Affordable Care Act.’’ The Affordable Care Act extended MHPAEA to apply to the individual health insurance market. Additionally, the Department of Health and Human Services (HHS) final regulation regarding essential health benefits (EHB) requires health insurance issuers offering non-grandfathered health insurance coverage in the individual and small group markets, through an Exchange or outside of an Exchange, to comply with the requirements of the MHPAEA regulations in order to satisfy the requirement to cover EHB (45 CFR 147.150 and 156.115). MHPAEA section 512(b) specifically amends the Public Health Service (PHS) Act to require plan administrators or health insurance issuers to provide, upon request, the criteria for medical necessity determinations made with respect to MH/SUD benefits to current or potential participants, beneficiaries, or contracting providers. The Interim Final Rules Under the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 (75 FR 5410, February 2, 2010) and the Final Rules under the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 set forth rules for providing criteria for medical necessity determinations. CMS oversees non-Federal governmental plans and health insurance issuers. MHPAEA section 512(b) specifically amends the PHS Act to require plan administrators or health insurance issuers to supply, upon request, the reason for any denial or reimbursement of payment for MH/SUD services to the participant or beneficiary involved in the case. The Interim Final Rules Under the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 (75 FR 5410, February 2, 2010) and the Final Rules under the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 implement 45 CFR 146.136(d)(2), which sets forth rules for providing reasons for claims denial. CMS oversees nonFederal governmental plans and health insurance issuers, and the regulation provides a safe harbor such that nonFederal governmental plans (and issuers offering coverage in connection with such plans) are deemed to comply with requirements of paragraph (d)(2) of 45 CFR 146.136 if they provide the reason for claims denial in a form and manner consistent with ERISA requirements found in 29 CFR 2560.503–1. Section PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 68331 146.136(d)(3) of the final rule clarifies that PHS Act section 2719 governing internal claims and appeals and external review as implemented by 45 CFR 147.136, covers MHPAEA claims denials and requires that, when a nonquantitative treatment limitation (NQTL) is the basis for a claims denial, that a non-grandfathered plan or issuer must provide the processes, strategies, evidentiary standard, and other factors used in developing and applying the NQTL with respect to med/surg benefits and MH/SUD benefits. Group health plan participants, beneficiaries, covered individuals in the individual market, or persons acting on their behalf, may use this optional model form to request information from plans regarding NQTLs that may affect patients’ MH/SUD benefits or that may have resulted in their coverage being denied. Form Number: CMS–10307 (OMB control number: 0938–1080); Frequency: On Occasion; Affected Public: State, Local, or Tribal Governments, Private Sector, Individuals; Number of Respondents: 250,137; Total Annual Responses: 987,714; Total Annual Hours: 35,475. (For policy questions regarding this collection contact Usree Bandyopadhyay at 410–786–6650.) 2. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Data Collection and Submission, Registration, Attestation, Dispute and Resolution, Record Retention, and Assumptions Document Submission, for Open Payments; Use: Section 6002 of the Affordable Care Act added section 1128G to the Social Security Act (the Act), which requires applicable manufacturers of covered drugs, devices, biologicals, or medical supplies (as defined at 42 CFR 403.902) to report annually to the Secretary certain payments or other transfers of value to covered recipients. Section 1128G of the Act also requires applicable manufacturers and applicable group purchasing organizations (GPOs) to report certain information regarding the ownership or investment interests held by physicians or the immediate family members of physicians in such entities. Specifically, manufacturers of covered drugs, devices, biologicals, and medical supplies (applicable manufacturers) are required to submit on an annual basis the information required in section 1128G(a)(1) of the Act about certain payments or other transfers of value made to covered recipients during the course of the preceding calendar year. Similarly, section 1128G(a)(2) of the Act requires applicable manufacturers and E:\FR\FM\28OCN1.SGM 28OCN1 68332 Federal Register / Vol. 85, No. 209 / Wednesday, October 28, 2020 / Notices applicable GPOs to disclose any ownership or investment interests in such entities held by physicians or their immediate family members, as well as information on any payments or other transfers of value provided to such physician owners or investors. Form Number: CMS–10495 (OMB control number: 0938–1237); Frequency: Once; Affected Public: Private sector; Business or other for-profits; Number of Respondents: 34,616; Total Annual Responses: 78,812; Total Annual Hours: 1,897,790. (For policy questions regarding this collection contact Kathleen Ott 410–786–4246.) Dated: October 23, 2020. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2020–23893 Filed 10–27–20; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS–10570 and CMS– 10437] Agency Information Collection Activities: Submission for OMB Review; 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 (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 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 jbell on DSKJLSW7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:29 Oct 27, 2020 Jkt 253001 for Certain Imaging Services,’’ which directs the Secretary to establish a program to promote the use of AUC. DATES: Comments on the collection(s) of This program is codified at 42 CFR information must be received by the 414.94. Evidence-based AUC for OMB desk officer by November 27, imaging can assist clinicians in selecting 2020. the imaging study that is most likely to ADDRESSES: Written comments and improve health outcomes for patients recommendations for the proposed based on their individual context. A information collection should be sent provider-led entity (PLE) as defined in within 30 days of publication of this 42 CFR 414.94(b) is a national notice to www.reginfo.gov/public/do/ professional medical specialty society or PRAMain. Find this particular other organization that is comprised information collection by selecting primarily of providers or practitioners ‘‘Currently under 30-day Review—Open who, either within the organization or for Public Comments’’ or by using the outside the organization, predominantly search function. provide direct patient care. This To obtain copies of a supporting program requires professionals ordering statement and any related forms for the applicable imaging services as defined proposed collection(s) summarized in in § 414.94(b) to consult with specified applicable AUC, which are criteria this notice, you may make your request developed, endorsed or modified by a using one of following: qualified PLE. 1. Access CMS’ website address at The cornerstone of the PLE website address at https://www.cms.gov/ qualification process is for PLEs to Regulations-and-Guidance/Legislation/ demonstrate that they engage in a PaperworkReductionActof1995/PRArigorous evidence-based process for Listing.html. 2. Call the Reports Clearance Office at developing, modifying, or endorsing AUC. Section 1834(q)(2)(B) specifies (410) 786–1326. that the Secretary must consider FOR FURTHER INFORMATION CONTACT: whether AUC have stakeholder William Parham at (410) 786–4669. consensus, are scientifically valid and SUPPLEMENTARY INFORMATION: Under the evidence-based, and are based on Paperwork Reduction Act of 1995 (PRA) studies that are published and (44 U.S.C. 3501–3520), federal agencies reviewable by stakeholders. In the 2016 must obtain approval from the Office of Physician Fee Schedule Final Rule with Management and Budget (OMB) for each comment period (80 FR 70886, collection of information they conduct November 16, 2015; see pages 71102– or sponsor. The term ‘‘collection of 71116 and pages 71380–71382) we information’’ is defined in 44 U.S.C. established a qualification process and 3502(3) and 5 CFR 1320.3(c) and requirements for qualified PLEs in order includes agency requests or to ensure that the AUC development or requirements that members of the public endorsement processes used by a PLE submit reports, keep records, or provide result in high quality, evidence-based information to a third party. Section AUC in accordance with section 3506(c)(2)(A) of the PRA (44 U.S.C. 1834(q)(2)(B). 3506(c)(2)(A)) requires federal agencies In order to become and remain a to publish a 30-day notice in the qualified PLE, we require PLEs to Federal Register concerning each demonstrate adherence to specific proposed collection of information, requirements when developing, including each proposed extension or modifying or endorsing AUC. To ensure reinstatement of an existing collection that these requirements are met, we of information, before submitting the require PLEs to submit information collection to OMB for approval. To demonstrating their adherence to these comply with this requirement, CMS is requirements. CMS qualifies those PLEs publishing this notice that summarizes that demonstrate adherence to the the following proposed collection(s) of requirements for a period of five years. information for public comment: Qualified PLEs are also required, during 1. Type of Information Collection the 5th year after their most recent Request: Reinstatement of a previously approval date, to ensure adherence has approved collection; Title of been maintained and to account for any Information Collection: Appropriate Use changes in the entities’ processes. Criteria (AUC) for Advanced Diagnostic Qualified PLEs must reapply every five Imaging Services; Use: Section 218(b) of years and must submit the applications the Protecting Access to Medicare Act by January 1 of the 5th year after the (PAMA) of 2014 amended the Medicare PLE’s most recent approval date. Form Number: CMS–10570 (OMB control Part B statute by adding a new section number: 0938–1288); Frequency: 1834(q) of the Act entitled, Occasionally; Affected Public: Private: ‘‘Recognizing Appropriate Use Criteria minimize the information collection burden. PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\28OCN1.SGM 28OCN1

Agencies

[Federal Register Volume 85, Number 209 (Wednesday, October 28, 2020)]
[Notices]
[Pages 68330-68332]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23893]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10307 and CMS-10495]


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 December 28, 2020.

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 
https://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 website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.
    2. Call the Reports Clearance Office at (410) 786-1326.

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

[[Page 68331]]


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-10307 Medical Necessity and Claims Denial Disclosures under MHPAEA
CMS-10495 Data Collection and Submission, Registration, Attestation, 
Dispute and Resolution, Record Retention, and Assumptions Document 
Submission, for Open Payments

    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: Extension of a currently 
approved collection; Title of Information Collection: Medical Necessity 
and Claims Denial Disclosures under MHPAEA; Use: The Paul Wellstone and 
Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 
(MHPAEA) (P.L.110-343) generally requires that group health plans and 
group health insurance issuers offering mental health or substance use 
disorder (MH/SUD) benefits in addition to medical and surgical (med/
surg) benefits ensure that they do not apply any more restrictive 
financial requirements (e.g., co-pays, deductibles) and/or treatment 
limitations (e.g., visit limits) to MH/SUD benefits than those 
requirements and/or limitations applied to substantially all med/surg 
benefits.
    The Patient Protection and Affordable Care Act, Public Law 111-148, 
was enacted on March 23, 2010, and the Health Care and Education 
Reconciliation Act of 2010, Public Law 111-152, was enacted on March 
30, 2010, collectively known as the ``Affordable Care Act.'' The 
Affordable Care Act extended MHPAEA to apply to the individual health 
insurance market. Additionally, the Department of Health and Human 
Services (HHS) final regulation regarding essential health benefits 
(EHB) requires health insurance issuers offering non-grandfathered 
health insurance coverage in the individual and small group markets, 
through an Exchange or outside of an Exchange, to comply with the 
requirements of the MHPAEA regulations in order to satisfy the 
requirement to cover EHB (45 CFR 147.150 and 156.115).
    MHPAEA section 512(b) specifically amends the Public Health Service 
(PHS) Act to require plan administrators or health insurance issuers to 
provide, upon request, the criteria for medical necessity 
determinations made with respect to MH/SUD benefits to current or 
potential participants, beneficiaries, or contracting providers. The 
Interim Final Rules Under the Paul Wellstone and Pete Domenici Mental 
Health Parity and Addiction Equity Act of 2008 (75 FR 5410, February 2, 
2010) and the Final Rules under the Paul Wellstone and Pete Domenici 
Mental Health Parity and Addiction Equity Act of 2008 set forth rules 
for providing criteria for medical necessity determinations. CMS 
oversees non-Federal governmental plans and health insurance issuers.
    MHPAEA section 512(b) specifically amends the PHS Act to require 
plan administrators or health insurance issuers to supply, upon 
request, the reason for any denial or reimbursement of payment for MH/
SUD services to the participant or beneficiary involved in the case. 
The Interim Final Rules Under the Paul Wellstone and Pete Domenici 
Mental Health Parity and Addiction Equity Act of 2008 (75 FR 5410, 
February 2, 2010) and the Final Rules under the Paul Wellstone and Pete 
Domenici Mental Health Parity and Addiction Equity Act of 2008 
implement 45 CFR 146.136(d)(2), which sets forth rules for providing 
reasons for claims denial. CMS oversees non-Federal governmental plans 
and health insurance issuers, and the regulation provides a safe harbor 
such that non-Federal governmental plans (and issuers offering coverage 
in connection with such plans) are deemed to comply with requirements 
of paragraph (d)(2) of 45 CFR 146.136 if they provide the reason for 
claims denial in a form and manner consistent with ERISA requirements 
found in 29 CFR 2560.503-1. Section 146.136(d)(3) of the final rule 
clarifies that PHS Act section 2719 governing internal claims and 
appeals and external review as implemented by 45 CFR 147.136, covers 
MHPAEA claims denials and requires that, when a non-quantitative 
treatment limitation (NQTL) is the basis for a claims denial, that a 
non-grandfathered plan or issuer must provide the processes, 
strategies, evidentiary standard, and other factors used in developing 
and applying the NQTL with respect to med/surg benefits and MH/SUD 
benefits.
    Group health plan participants, beneficiaries, covered individuals 
in the individual market, or persons acting on their behalf, may use 
this optional model form to request information from plans regarding 
NQTLs that may affect patients' MH/SUD benefits or that may have 
resulted in their coverage being denied. Form Number: CMS-10307 (OMB 
control number: 0938-1080); Frequency: On Occasion; Affected Public: 
State, Local, or Tribal Governments, Private Sector, Individuals; 
Number of Respondents: 250,137; Total Annual Responses: 987,714; Total 
Annual Hours: 35,475. (For policy questions regarding this collection 
contact Usree Bandyopadhyay at 410-786-6650.)
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Data Collection 
and Submission, Registration, Attestation, Dispute and Resolution, 
Record Retention, and Assumptions Document Submission, for Open 
Payments; Use: Section 6002 of the Affordable Care Act added section 
1128G to the Social Security Act (the Act), which requires applicable 
manufacturers of covered drugs, devices, biologicals, or medical 
supplies (as defined at 42 CFR 403.902) to report annually to the 
Secretary certain payments or other transfers of value to covered 
recipients. Section 1128G of the Act also requires applicable 
manufacturers and applicable group purchasing organizations (GPOs) to 
report certain information regarding the ownership or investment 
interests held by physicians or the immediate family members of 
physicians in such entities.
    Specifically, manufacturers of covered drugs, devices, biologicals, 
and medical supplies (applicable manufacturers) are required to submit 
on an annual basis the information required in section 1128G(a)(1) of 
the Act about certain payments or other transfers of value made to 
covered recipients during the course of the preceding calendar year. 
Similarly, section 1128G(a)(2) of the Act requires applicable 
manufacturers and

[[Page 68332]]

applicable GPOs to disclose any ownership or investment interests in 
such entities held by physicians or their immediate family members, as 
well as information on any payments or other transfers of value 
provided to such physician owners or investors. Form Number: CMS-10495 
(OMB control number: 0938-1237); Frequency: Once; Affected Public: 
Private sector; Business or other for-profits; Number of Respondents: 
34,616; Total Annual Responses: 78,812; Total Annual Hours: 1,897,790. 
(For policy questions regarding this collection contact Kathleen Ott 
410-786-4246.)

    Dated: October 23, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2020-23893 Filed 10-27-20; 8:45 am]
BILLING CODE 4120-01-P
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