83 FR 26693 - Agency Information Collection Activities: Proposed Collection; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 83, Issue 111 (June 8, 2018)
Centers for Medicare & Medicaid Services
Federal Register Volume 83, Issue 111 (June 8, 2018)
| Page Range | 26693-26694 | |
| FR Document | 2018-12394 |
[Federal Register Volume 83, Number 111 (Friday, June 8, 2018)] [Notices] [Pages 26693-26694] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-12394] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifiers: CMS-10418] Agency Information Collection Activities: Proposed Collection; 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 (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 August 7, 2018. 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. 2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to Paperwork@cms.hhs.gov. 3. Call the Reports Clearance Office at (410) 786-1326. FOR FURTHER INFORMATION CONTACT: William 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-10418 Annual MLR and Rebate Calculation Report and MLR Rebate Notices 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 [[Page 26694]] 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: Annual MLR and Rebate Calculation Report and MLR Rebate Notices; Use: Under Section 2718 of the Affordable Care Act and implementing regulation at 45 CFR part 158, a health insurance issuer (issuer) offering group or individual health insurance coverage must submit a report to the Secretary concerning the amount the issuer spends each year on claims, quality improvement expenses, non-claims costs, Federal and State taxes and licensing and regulatory fees, the amount of earned premium, and beginning with the 2014 reporting year, the amounts related to the transitional reinsurance, risk corridors, and risk adjustment programs established under sections 1341, 1342, and 1343, respectively, of the Affordable Care Act. An issuer must provide an annual rebate if the amount it spends on certain costs compared to its premium revenue (excluding Federal and States taxes and licensing and regulatory fees) does not meet a certain ratio, referred to as the medical loss ratio (MLR). Each issuer is required to submit annually MLR data, including information about any rebates it must provide, on a form prescribed by CMS, for each State in which the issuer conducts business. Each issuer is also required to provide a rebate notice to each policyholder that is owed a rebate and each subscriber of policyholders that are owed a rebate for any given MLR reporting year. Additionally, each issuer is required to maintain for a period of seven years all documents, records and other evidence that support the data included in each issuer's annual report to the Secretary. Based upon CMS' experience in the MLR data collection and evaluation process, CMS is updating its annual burden hour estimates to reflect the actual numbers of submissions, rebates and rebate notices. The 2017 MLR Reporting Form and Instructions reflect changes for the 2017 reporting year and beyond. The 2017 MLR Reporting Form and instructions are also modified to eliminate the reporting elements that were required under the risk corridors data submission requirements in 45 CFR 153.530 for the 2014 through 2016 benefit years. For 2017, it is expected that issuers will submit fewer reports and on average, send fewer notices and rebate checks in the mail to policyholders and subscribers, which will reduce burden on issuers. In addition, issuers of qualified health plans will no longer have to submit on the annual report the data for the risk corridors program established under section 1342 of the Patient Protection and Affordable Care Act. Form Number: CMS-10418 (OMB control number: 0938-1164); Frequency: Annually; Affected Public: Private Sector, Business or other for-profit and not- for-profit institutions; Number of Respondents: 522; Number of Responses: 2,138; Total Annual Hours: 170,589. (For policy questions regarding this collection contact Christina Whitefield at 301-492- 4172.) Dated: June 5, 2018. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2018-12394 Filed 6-7-18; 8:45 am] BILLING CODE 4120-01-P
![Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Notices 26693
of the drug under Medicare Part D. Per after the dis-enrollment date. Form recommendations must be submitted in
statute, drugs that are necessary for the Number: CMS–10544 (OMB control any one of the following ways:
palliation and management of the number: 0938–1271); Frequency: 1. Electronically. You may send your
terminal illness and related conditions Reporting—Monthly; Affected Public: comments electronically to http://
are not eligible for payment under Part Private Sector (Business or other for- www.regulations.gov. Follow the
D. The standard form provides a vehicle profit institutions); Number of instructions for ‘‘Comment or
for the hospice provider, prescriber or Respondents: 10,008; Total Annual Submission’’ or ‘‘More Search Options’’
sponsor to document that the drug Responses: 10,008; Total Annual Hours: to find the information collection
prescribed is ‘‘unrelated’’ to the 6,665. (For policy questions regarding document(s) that are accepting
terminal illness and related conditions. this collection contact Carla Patterson at comments.
It also gives a hospice organization the 410–786–1000.) 2. By regular mail. You may mail
option to communicate a beneficiary’s Dated: June 5, 2018. written comments to the following
change in hospice status and care plan William N. Parham, III,
address: CMS, Office of Strategic
to Part D sponsors. Form Number: CMS– Operations and Regulatory Affairs,
Director, Paperwork Reduction Staff, Office
10538 (OMB control number: 0938– of Strategic Operations and Regulatory
Division of Regulations Development,
1269); Frequency: Occasionally; Affairs. Attention: Document Identifier/OMB
Affected Public: Private sector (business [FR Doc. 2018–12393 Filed 6–7–18; 8:45 am]
Control Number ll, Room C4–26–05,
or other for-profits); Number of 7500 Security Boulevard, Baltimore,
BILLING CODE 4120–01–P
Respondents: 424; Total Annual Maryland 21244–1850.
Responses: 376,487; Total Annual To obtain copies of a supporting
Hours: 31,374. (For policy questions DEPARTMENT OF HEALTH AND statement and any related forms for the
regarding this collection contact Shelly HUMAN SERVICES proposed collection(s) summarized in
Winston at 410–786–3694.) this notice, you may make your request
6. Type of Information Collection Centers for Medicare & Medicaid using one of following:
Request: Reinstatement without change Services 1. Access CMS’ website address at
of a previously approved collection; https://www.cms.gov/Regulations-and-
[Document Identifiers: CMS–10418]
Title of Information Collection: Good Guidance/Legislation/PaperworkReducti
Cause Processes; Use: Section Agency Information Collection onActof1995/PRA-Listing.html.
1851(g)(3)(B)(i) of the Act provides that Activities: Proposed Collection; 2. Email your request, including your
MA organizations may terminate the Comment Request address, phone number, OMB number,
enrollment of individuals who fail to and CMS document identifier, to
pay basic and supplemental premiums AGENCY: Centers for Medicare & Paperwork@cms.hhs.gov.
after a grace period established by the Medicaid Services, HHS. 3. Call the Reports Clearance Office at
plan. Section 1860D–1(b)(1)(B)(v) of the ACTION: Notice. (410) 786–1326.
Act generally directs us to establish FOR FURTHER INFORMATION CONTACT:
rules related to enrollment, dis- SUMMARY: The Centers for Medicare & William Parham at (410) 786–4669.
enrollment, and termination for Part D Medicaid Services (CMS) is announcing
SUPPLEMENTARY INFORMATION:
plan sponsors that are similar to those an opportunity for the public to
established for MA organizations under comment on CMS’ intention to collect Contents
section 1851 of the Act. Consistent with information from the public. Under the
This notice sets out a summary of the
these sections of the Act, subpart B in Paperwork Reduction Act of 1995 (the
use and burden associated with the
each of the Parts C and D regulations PRA), federal agencies are required to
following information collections. More
sets forth requirements with respect to publish notice in the Federal Register
detailed information can be found in
involuntary dis-enrollment procedures concerning each proposed collection of
each collection’s supporting statement
at 42 CFR 422.74 and 423.44, information (including each proposed
and associated materials (see
respectively. In addition, section extension or reinstatement of an existing
ADDRESSES).
1876(c)(3)(B) establishes that collection of information) and to allow
individuals may be dis-enrolled from 60 days for public comment on the CMS–10418 Annual MLR and Rebate
coverage as specified in regulations. proposed action. Interested persons are Calculation Report and MLR Rebate
Thus, current regulations at 42 CFR invited to send comments regarding our Notices
417.460 specify that a cost plan, burden estimates or any other aspect of Under the PRA (44 U.S.C. 3501–
specifically a Health Maintenance this collection of information, including 3520), federal agencies must obtain
Organization (HMO) or competitive the necessity and utility of the proposed approval from the Office of Management
medical plan (CMP), may dis-enroll a information collection for the proper and Budget (OMB) for each collection of
member who fails to pay premiums or performance of the agency’s functions, information they conduct or sponsor.
other charges imposed by the plan for the accuracy of the estimated burden, The term ‘‘collection of information’’ is
deductible and coinsurance amounts. ways to enhance the quality, utility, and defined in 44 U.S.C. 3502(3) and 5 CFR
Within these regulatory provisions, clarity of the information to be 1320.3(c) and includes agency requests
individuals dis-enrolled for collected, and the use of automated or requirements that members of the
nonpayment of premiums are afforded a collection techniques or other forms of public submit reports, keep records, or
grace period in which to request information technology to minimize the provide information to a third party.
amozie on DSK3GDR082PROD with NOTICES1
reinstatement. As part of the information collection burden. Section 3506(c)(2)(A) of the PRA
reinstatement request process, they DATES: Comments must be received by requires federal agencies to publish a
must demonstrate good cause for failure August 7, 2018. 60-day notice in the Federal Register
to pay within the initial grace period ADDRESSES: When commenting, please concerning each proposed collection of
that led to their involuntary dis- reference the document identifier or information, including each proposed
enrollment and pay all overdue OMB control number. To be assured extension or reinstatement of an existing
premiums within three calendar months consideration, comments and collection of information, before
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![26694 Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Notices
submitting the collection to OMB for the mail to policyholders and FOR FURTHER INFORMATION CONTACT:
approval. To comply with this subscribers, which will reduce burden Amber Sanford, Office of Operations,
requirement, CMS is publishing this on issuers. In addition, issuers of Food and Drug Administration, Three
notice. qualified health plans will no longer White Flint North, 10A–12M, 11601
have to submit on the annual report the Landsdown St., North Bethesda, MD
Information Collection
data for the risk corridors program 20852, 301–796–8867, PRAStaff@
1. Type of Information Collection established under section 1342 of the fda.hhs.gov.
Request: Revision of a currently Patient Protection and Affordable Care SUPPLEMENTARY INFORMATION: In
approved collection; Title of Act. Form Number: CMS–10418 (OMB compliance with 44 U.S.C. 3507, FDA
Information Collection: Annual MLR control number: 0938–1164); Frequency: has submitted the following proposed
and Rebate Calculation Report and MLR Annually; Affected Public: Private collection of information to OMB for
Rebate Notices; Use: Under Section Sector, Business or other for-profit and review and clearance.
2718 of the Affordable Care Act and not-for-profit institutions; Number of
implementing regulation at 45 CFR part Respondents: 522; Number of Medical Device Reporting: Electronic
158, a health insurance issuer (issuer) Responses: 2,138; Total Annual Hours: Submission Requirements
offering group or individual health 170,589. (For policy questions regarding OMB Control Number 0910–0437—
insurance coverage must submit a report this collection contact Christina Extension
to the Secretary concerning the amount Whitefield at 301–492–4172.)
the issuer spends each year on claims, The information collection associated
quality improvement expenses, non- Dated: June 5, 2018. with 21 CFR part 803 is approved under
claims costs, Federal and State taxes William N. Parham, III, OMB control number 0910–0437. We
and licensing and regulatory fees, the Director, Paperwork Reduction Staff, Office request revision of the information
amount of earned premium, and of Strategic Operations and Regulatory collection approval as described in this
beginning with the 2014 reporting year, Affairs. document.
the amounts related to the transitional [FR Doc. 2018–12394 Filed 6–7–18; 8:45 am] In the Federal Register of December
reinsurance, risk corridors, and risk BILLING CODE 4120–01–P 26, 2017 (82 FR 60922), FDA published
adjustment programs established under a notification and request for comments
sections 1341, 1342, and 1343, entitled ‘‘Center for Devices and
respectively, of the Affordable Care Act. DEPARTMENT OF HEALTH AND Radiological Health; Medical Devices
An issuer must provide an annual rebate HUMAN SERVICES and Combination Products; Voluntary
if the amount it spends on certain costs Malfunction Summary Reporting
compared to its premium revenue Food and Drug Administration Program for Manufacturers’’ (the
(excluding Federal and States taxes and notification) which, among other things,
licensing and regulatory fees) does not [Docket No. FDA–2017–N–6730] proposed a program for manufacturer
meet a certain ratio, referred to as the reporting of certain device malfunction
medical loss ratio (MLR). Each issuer is Agency Information Collection medical device reports (MDRs) in
required to submit annually MLR data, Activities; Submission for Office of summary form—the Voluntary
including information about any rebates Management and Budget Review; Malfunction Summary Reporting
it must provide, on a form prescribed by Comment Request; Voluntary Program. The proposed program would
CMS, for each State in which the issuer Malfunction Summary Reporting permit manufacturers of devices in
conducts business. Each issuer is also Program for Manufacturers certain product codes to report
required to provide a rebate notice to AGENCY: Food and Drug Administration, malfunctions for those devices on a
each policyholder that is owed a rebate HHS. quarterly basis and in a summary format
and each subscriber of policyholders (instead of reporting them as individual,
ACTION: Notice. 30-day reports), subject to certain
that are owed a rebate for any given
MLR reporting year. Additionally, each SUMMARY: The Food and Drug conditions. Therefore, we have added a
issuer is required to maintain for a Administration (FDA) is announcing line item to the reporting burden table
period of seven years all documents, that a proposed collection of in OMB control number 0910–0437,
records and other evidence that support information has been submitted to the ‘‘Medical Device Reporting: Electronic
the data included in each issuer’s Office of Management and Budget Submission Requirements,’’ for the
annual report to the Secretary. Based (OMB) for review and clearance under proposed Voluntary Malfunction
upon CMS’ experience in the MLR data the Paperwork Reduction Act of 1995. Summary Reporting Program.
collection and evaluation process, CMS FDA believes that submission of
DATES: Fax written comments on the
is updating its annual burden hour voluntary summary reports in the
collection of information by July 9, format described in this document
estimates to reflect the actual numbers
2018. would provide the most compact and
of submissions, rebates and rebate
notices. ADDRESSES: To ensure that comments on efficient reporting mechanism for
The 2017 MLR Reporting Form and the information collection are received, streamlining malfunction reporting that
Instructions reflect changes for the 2017 OMB recommends that written still provides sufficient detail for FDA to
reporting year and beyond. The 2017 comments be faxed to the Office of monitor devices effectively. The
MLR Reporting Form and instructions Information and Regulatory Affairs, proposed Voluntary Malfunction
are also modified to eliminate the OMB, Attn: FDA Desk Officer, Fax: 202– Summary Reporting Program is meant to
amozie on DSK3GDR082PROD with NOTICES1
reporting elements that were required 395–7285, or emailed to oira_ streamline the process of reporting
under the risk corridors data submission submission@omb.eop.gov. All malfunctions. It does not change
requirements in 45 CFR 153.530 for the comments should be identified with the regulatory requirements for MDR-related
2014 through 2016 benefit years. For OMB control number 0910–0437. Also investigations or recordkeeping by
2017, it is expected that issuers will include the FDA docket number found manufacturers. The proposed program
submit fewer reports and on average, in brackets in the heading of this would neither apply to importers or
send fewer notices and rebate checks in document. device user facilities, nor affect
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Document Created: 2018-06-08 01:23:08
Document Modified: 2018-06-08 01:23:08
| 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 7, 2018. | |
| Contact | William Parham at (410) 786-4669. | |
| FR Citation | 83 FR 26693 |
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