83 FR 56085 - Agency Information Collection Activities: Proposed Collection; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 83, Issue 218 (November 9, 2018)
Centers for Medicare & Medicaid Services
Federal Register Volume 83, Issue 218 (November 9, 2018)
| Page Range | 56085-56086 | |
| FR Document | 2018-24592 |
[Federal Register Volume 83, Number 218 (Friday, November 9, 2018)] [Notices] [Pages 56085-56086] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-24592] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier CMS-R-240 and CMS-10164] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Centers for Medicare & Medicaid Services. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including 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 January 8, 2019. 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 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). [[Page 56086]] CMS-R-240 Prospective Payments for Hospital Outpatient Services CMS-10164 Medicare EDI Enrollment Form and EDI Registration 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: Reinstatement of a previously approved collection; Title of Information Collection: Prospective Payments for Hospital Outpatient Services; Use: Section 1833(t) of the Act, as added by section 4523 of the Balanced Budget Act of 1997 (the BBA) requires the Secretary to establish a prospective payment system (PPS) for hospital outpatient services. Successful implementation of an outpatient PPS requires that CMS distinguish facilities or organizations that function as departments of hospitals from those that are freestanding, so that CMS can determine which services should be paid under the OPPS, the clinical laboratory fee schedule, or other payment provisions applicable to services furnished to hospital outpatients. Information from the reports required under sections 413.65(b)(3) and (c) is needed to make these determinations. In addition, section 1866(b)(2) of the Act authorizes hospitals and other providers to impose deductible and coinsurance charges for facility services, but does not allow such charges by facilities or organizations which are not provider-based. Implementation of this provision requires that CMS have information from the required reports, so it can determine which facilities are provider-based. Form Number: CMS-R-240 (OMB control number: 0938-0798); Frequency: Yearly; Affected Public: Private Sector (Business or other for-profits, Not-for-Profit Institutions); Number of Respondents: 750; Total Annual Responses: 13,649,150; Total Annual Hours: 680,920 (For policy questions regarding this collection contact Emily Lipkin at 410-786-3633.) 2. Type of Information Collection Request: Reinstatement of a previously approved collection; Title of Information Collection: Medicare EDI Enrollment Form and EDI Registration; Use: The Congress, recognizing the need to simplify the administration of health care transactions, enacted the Health Insurance Portability and Accountability Act of 1996 (HIPAA), Public Law 104-191, on August 21, 1996. Title II, Subtitle F of this legislation directs the Secretary of the Department of Health and Human Services to develop unique standards for specified electronic transactions and code sets for those transactions. The purpose of this Subtitle is to improve the Medicare and Medicaid programs in particular and the efficiency and effectiveness of the health care industry in general through the establishment of standards and requirements to facilitate the electronic transmission of certain health information. This Subtitle also requires that the Secretary adopt standards for financial and administrative transactions, and data elements for those transactions to enable health information to be exchanged electronically. The Standards for Electronic Transactions final rule, 45 CFR part 162 Subpart K Sec. 162.1101 through Subpart R Sec. 162.1802, (hereinafter referred to as ``Transactions Rule'') published August 17, 2000 adopted standards for health care transactions and code sets. Subsequent to the Transactions Rule, CMS-0003-P and CMS-0005-P proposed modifications to the adopted standards essential to permit initial implementation of the standards throughout the entire healthcare industry. Currently, Medicare contractors have a process in place to enroll providers for electronic billing and other EDI transactions. In support of the HIPAA Transactions Rule, the purpose of this Paperwork Reduction Act (PRA) request is to establish a common form that is sufficient to address all HIPAA transactions. Form Number: CMS-10164 (OMB control number: 0938-0983); Frequency: Hourly; Affected Public: Private Sector (Business or other for-profits, Not-for-Profit Institutions); Number of Respondents: 193,268; Number of Responses: 193,268; Total Annual Hours: 64,423. (For policy questions regarding this collection, contact Matt Klischer at 410-786-7488.) Dated: November 6, 2018. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2018-24592 Filed 11-8-18; 8:45 am] BILLING CODE 4120-01-P
![Federal Register / Vol. 83, No. 218 / Friday, November 9, 2018 / Notices 56085
abbreviated version of the RFI rating Information requests can also be proposed action. Interested persons are
system consistent with the Board’s submitted by email to DCAS@CDC.GOV. invited to send comments regarding our
practice for BHCs outlined in SR 13–21. SUPPLEMENTARY INFORMATION: burden estimates or any other aspect of
An offsite review of the SLHC will be Authority: 42 U.S.C. 7384q(b). 42 U.S.C.
this collection of information, including
conducted upon receipt of the lead 7384l(14)(C). the necessity and utility of the proposed
depository institution’s report of On October 18, 2018, as provided for information collection for the proper
examination. The supervisory cycle will under 42 U.S.C. 7384l(14)(C), the performance of the agency’s functions,
be determined by the examination Secretary of HHS designated the the accuracy of the estimated burden,
frequency of the lead depository following class of employees as an ways to enhance the quality, utility, and
institution and the SLHC will be addition to the SEC: clarity of the information to be
assigned only a risk management rating collected, and the use of automated
and a composite rating. All employees of the Department of
Energy, its predecessor agencies, and its
collection techniques or other forms of
Moreover, SLHCs have been subject to information technology to minimize the
contractors or subcontractors who worked in
the RFI rating system on indicative basis any area at the Sandia National Laboratories information collection burden.
for the past seven years, which has in Albuquerque, New Mexico, during the DATES: Comments must be received by
provided SLHCs the opportunity to period from January 1, 1995, through January 8, 2019.
adjust to the RFI rating system. The full December 31, 1996, for a number of work
application of the RFI rating system to days aggregating at least 250 work days, ADDRESSES: When commenting, please
small non-commercial and non- occurring either solely under this reference the document identifier or
insurance SLHCs will not create any employment or in combination with work OMB control number. To be assured
new economic impact on small entities. days within the parameters established for consideration, comments and
In light of the foregoing, the Board one or more other classes of employees recommendations must be submitted in
included in the Special Exposure Cohort. any one of the following ways:
does not believe that this final rule will
have a significant economic impact on This designation will become 1. Electronically. You may send your
any small entities and therefore believes effective on November 17, 2018, unless comments electronically to http://
that there are no significant alternatives Congress provides otherwise prior to the www.regulations.gov. Follow the
that would reduce the economic impact effective date. After this effective date, instructions for ‘‘Comment or
on small entities. HHS will publish a notice in the Submission’’ or ‘‘More Search Options’’
Federal Register reporting the addition to find the information collection
By order of the Board of Governors of the
Federal Reserve System, November 2, 2018. of this class to the SEC or the result of document(s) that are accepting
Ann Misback,
any provision by Congress regarding the comments.
decision by HHS to add the class to the 2. By regular mail. You may mail
Secretary of the Board.
SEC. written comments to the following
[FR Doc. 2018–24496 Filed 11–8–18; 8:45 am]
John J. Howard,
address: CMS, Office of Strategic
BILLING CODE 6210–01–P
Operations and Regulatory Affairs,
Director, National Institute for Occupational
Safety and Health. Division of Regulations Development,
Attention: Document Identifier/OMB
DEPARTMENT OF HEALTH AND [FR Doc. 2018–24530 Filed 11–8–18; 8:45 am]
Control Number ll, Room C4–26–05,
HUMAN SERVICES BILLING CODE 4163–19–P
7500 Security Boulevard, Baltimore,
Centers for Disease Control and Maryland 21244–1850.
Prevention DEPARTMENT OF HEALTH AND To obtain copies of a supporting
HUMAN SERVICES statement and any related forms for the
Decision to Designate a Class of proposed collection(s) summarized in
Employees From the Sandia National Centers for Medicare & Medicaid this notice, you may make your request
Laboratories in Albuquerque, New Services using one of following:
Mexico, To Be Included in the Special 1. Access CMS’ website address at
[Document Identifier CMS–R–240 and CMS–
Exposure Cohort 10164]
website address at https://www.cms.gov/
Regulations-and-Guidance/Legislation/
AGENCY: National Institute for PaperworkReductionActof1995/PRA-
Occupational Safety and Health Agency Information Collection
Activities: Proposed Collection; Listing.html.
(NIOSH), Centers for Disease Control 2. Email your request, including your
and Prevention, Department of Health Comment Request
address, phone number, OMB number,
and Human Services. AGENCY: Centers for Medicare & and CMS document identifier, to
ACTION: Notice. Medicaid Services. Paperwork@cms.hhs.gov.
ACTION: Notice. 3. Call the Reports Clearance Office at
SUMMARY: HHS gives notice of a
decision to designate a class of SUMMARY: The Centers for Medicare & (410) 786–1326.
employees from the Sandia National Medicaid Services (CMS) is announcing FOR FURTHER INFORMATION CONTACT:
Laboratories in Albuquerque, New an opportunity for the public to William Parham at (410) 786–4669.
Mexico, as an addition to the Special comment on CMS’ intention to collect SUPPLEMENTARY INFORMATION:
Exposure Cohort (SEC) under the Energy information from the public. Under the
Employees Occupational Illness Paperwork Reduction Act of 1995 (the Contents
khammond on DSK30JT082PROD with NOTICES
Compensation Program Act of 2000. PRA), federal agencies are required to This notice sets out a summary of the
FOR FURTHER INFORMATION CONTACT: publish notice in the Federal Register use and burden associated with the
Stuart L. Hinnefeld, Director, Division concerning each proposed collection of following information collections. More
of Compensation Analysis and Support, information (including each proposed detailed information can be found in
NIOSH, 1090 Tusculum Avenue, MS C– extension or reinstatement of an existing each collection’s supporting statement
46, Cincinnati, OH 45226–1938, collection of information) and to allow and associated materials (see
Telephone 1–877–222–7570. 60 days for public comment on the ADDRESSES).
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![56086 Federal Register / Vol. 83, No. 218 / Friday, November 9, 2018 / Notices
CMS–R–240 Prospective Payments for (OMB control number: 0938–0798); Frequency: Hourly; Affected Public:
Hospital Outpatient Services Frequency: Yearly; Affected Public: Private Sector (Business or other for-
CMS–10164 Medicare EDI Enrollment Private Sector (Business or other for- profits, Not-for-Profit Institutions);
Form and EDI Registration profits, Not-for-Profit Institutions); Number of Respondents: 193,268;
Under the PRA (44 U.S.C. 3501– Number of Respondents: 750; Total Number of Responses: 193,268; Total
3520), federal agencies must obtain Annual Responses: 13,649,150; Total Annual Hours: 64,423. (For policy
approval from the Office of Management Annual Hours: 680,920 (For policy questions regarding this collection,
and Budget (OMB) for each collection of questions regarding this collection contact Matt Klischer at 410–786–7488.)
information they conduct or sponsor. contact Emily Lipkin at 410–786–3633.) Dated: November 6, 2018.
The term ‘‘collection of information’’ is 2. Type of Information Collection William N. Parham, III,
defined in 44 U.S.C. 3502(3) and 5 CFR Request: Reinstatement of a previously
Director, Paperwork Reduction Staff, Office
1320.3(c) and includes agency requests approved collection; Title of of Strategic Operations and Regulatory
or requirements that members of the Information Collection: Medicare EDI Affairs.
public submit reports, keep records, or Enrollment Form and EDI Registration; [FR Doc. 2018–24592 Filed 11–8–18; 8:45 am]
provide information to a third party. Use: The Congress, recognizing the need
BILLING CODE 4120–01–P
Section 3506(c)(2)(A) of the PRA to simplify the administration of health
requires federal agencies to publish a care transactions, enacted the Health
60-day notice in the Federal Register Insurance Portability and DEPARTMENT OF HEALTH AND
concerning each proposed collection of Accountability Act of 1996 (HIPAA), HUMAN SERVICES
information, including each proposed Public Law 104–191, on August 21,
extension or reinstatement of an existing 1996. Title II, Subtitle F of this Food and Drug Administration
collection of information, before legislation directs the Secretary of the
submitting the collection to OMB for Department of Health and Human [Docket No. FDA–2018–N–4099]
approval. To comply with this Services to develop unique standards
for specified electronic transactions and Tedor Pharma, Inc., et al.; Withdrawal
requirement, CMS is publishing this
code sets for those transactions. The of Approval of 10 Abbreviated New
notice.
purpose of this Subtitle is to improve Drug Applications
Information Collection the Medicare and Medicaid programs in AGENCY: Food and Drug Administration,
1. Type of Information Collection particular and the efficiency and HHS.
Request: Reinstatement of a previously effectiveness of the health care industry
ACTION: Notice.
approved collection; Title of in general through the establishment of
Information Collection: Prospective standards and requirements to facilitate SUMMARY: The Food and Drug
Payments for Hospital Outpatient the electronic transmission of certain Administration (FDA or Agency) is
Services; Use: Section 1833(t) of the Act, health information. This Subtitle also withdrawing approval of 10 abbreviated
as added by section 4523 of the requires that the Secretary adopt new drug applications (ANDAs) from
Balanced Budget Act of 1997 (the BBA) standards for financial and multiple applicants. The applicants
requires the Secretary to establish a administrative transactions, and data notified the Agency in writing that the
prospective payment system (PPS) for elements for those transactions to enable drug products were no longer marketed
hospital outpatient services. Successful health information to be exchanged and requested that the approval of the
implementation of an outpatient PPS electronically. The Standards for applications be withdrawn.
requires that CMS distinguish facilities Electronic Transactions final rule, 45
DATES: Approval is withdrawn as of
or organizations that function as CFR part 162 Subpart K § 162.1101
through Subpart R § 162.1802, December 10, 2018.
departments of hospitals from those that
are freestanding, so that CMS can (hereinafter referred to as ‘‘Transactions FOR FURTHER INFORMATION CONTACT:
determine which services should be Rule’’) published August 17, 2000 Trang Tran, Center for Drug Evaluation
paid under the OPPS, the clinical adopted standards for health care and Research, Food and Drug
laboratory fee schedule, or other transactions and code sets. Subsequent Administration, 10903 New Hampshire
payment provisions applicable to to the Transactions Rule, CMS–0003–P Ave., Bldg. 75, Rm. 1671, Silver Spring,
services furnished to hospital and CMS–0005–P proposed MD 20993–0002, 240–402–7945,
outpatients. Information from the modifications to the adopted standards Trang.Tran@fda.hhs.gov.
reports required under sections essential to permit initial SUPPLEMENTARY INFORMATION: The
413.65(b)(3) and (c) is needed to make implementation of the standards applicants listed in the table have
these determinations. In addition, throughout the entire healthcare informed FDA that these drug products
section 1866(b)(2) of the Act authorizes industry. are no longer marketed and have
hospitals and other providers to impose Currently, Medicare contractors have requested that FDA withdraw approval
deductible and coinsurance charges for a process in place to enroll providers for of the applications under the process
facility services, but does not allow such electronic billing and other EDI described in § 314.150(c) (21 CFR
charges by facilities or organizations transactions. In support of the HIPAA 314.150(c)). The applicants have also,
which are not provider-based. Transactions Rule, the purpose of this by their requests, waived their
khammond on DSK30JT082PROD with NOTICES
Implementation of this provision Paperwork Reduction Act (PRA) request opportunity for a hearing. Withdrawal
requires that CMS have information is to establish a common form that is of approval of an application or
from the required reports, so it can sufficient to address all HIPAA abbreviated application under
determine which facilities are provider- transactions. Form Number: CMS–10164 § 314.150(c) is without prejudice to
based. Form Number: CMS–R–240 (OMB control number: 0938–0983); refiling.
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Document Created: 2018-11-09 03:33:51
Document Modified: 2018-11-09 03:33:51
| 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 January 8, 2019. | |
| Contact | William Parham at (410) 786-4669. | |
| FR Citation | 83 FR 56085 |
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