83 FR 63647 - Agency Information Collection Activities: Proposed Collection; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 83, Issue 237 (December 11, 2018)
Centers for Medicare & Medicaid Services
Federal Register Volume 83, Issue 237 (December 11, 2018)
| Page Range | 63647-63648 | |
| FR Document | 2018-26790 |
[Federal Register Volume 83, Number 237 (Tuesday, December 11, 2018)] [Notices] [Pages 63647-63648] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-26790] [[Page 63647]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10102 and CMS-10377] 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 February 11, 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' 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 [email protected]. 3. Call the Reports Clearance Office at (410) 786-1326. FOR FURTHER INFORMATION CONTACT: Reports Clearance Office 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-10102 National Implementation of the Hospital CAHPS Survey CMS-10377 Student Health Insurance Coverage 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: Revision of a currently approved collection; Title of Information Collection: National Implementation of the Hospital CAHPS Survey; Use: The HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) Survey, also known as the CAHPS[supreg] Hospital Survey or Hospital CAHPS[supreg], is a standardized survey instrument and data collection methodology that has been in use since 2006 to measure patients' perspectives of hospital care. While many hospitals collect information on patient satisfaction, HCAHPS created a national standard for the collection and public reporting of information that enables valid comparisons to be made across all hospitals to support consumer choice. In the FY 2018 IPPS/LTCH PPS final rule (82 FR 38328 through 38342), out of an abundance of caution, in the face of a nationwide epidemic of opioid over prescription, we finalized a refinement to the HCAHPS Survey measure as used in the Hospital Inpatient Quality Reporting Program by removing the previously adopted Pain Management questions and incorporating new Communication About Pain questions beginning with patients discharged in January 2018. As discussed in the CY 2019 OPPS/ASC proposed rule (83 FR 37218), since finalization of the Communication About Pain questions, we have received feedback that some stakeholders are concerned that, although the revised questions focus on communications with patients about their pain and treatment of that pain, rather than how well their pain was controlled, the questions still could potentially impose pressure on hospital staff to prescribe more opioids in order to achieve higher scores on the HCAHPS Survey. In response to stakeholder feedback, recommendations from the President's Commission on Combatting Drug Addiction and the Opioid Crisis, to comply with the requirements of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (Pub. L. 115-271), and to avoid any potential unintended consequences under the Hospital Inpatient Quality Reporting (IQR) Program, CMS is revising the HCAHPS survey by removing the three recently revised pain communication questions. The removal of these questions is effective with October 2019 discharges. At that point, the HCAHPS Survey will consist of 29 questions which will decrease the burden hours. Form Number: CMS-10102 (OMB control number 0938-0981); Frequency: Occasionally; Affected Public: Private sector (Business or other for-profits and Not-for-profit institutions); Number of Respondents: 4,200; Total Annual Responses: 3,104,200; Total Annual Hours: 379,290. (For policy questions regarding this collection contact William Lehrman at 410-786-1037.) 2. Type of Information Collection Request: Extension; Title of Information Collection: Student Health Insurance Coverage; Use: Under the Student [[Page 63648]] Health Insurance Coverage Final Rule published March 21, 2012 (77 FR 16453), student health insurance coverage is a type of individual health insurance coverage provided pursuant to a written agreement between an institution of higher education (as defined in the Higher Education Act of 1965) and a health insurance issuer, and provided to students who are enrolled in that institution and their dependents. The Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2017 Final Rule provided that, for policy years beginning on or after July 1, 2016, student health insurance coverage is exempt from the actuarial value (AV) requirements under section 1302(d) of the Affordable Care Act, but must provide coverage with an AV of at least 60 percent. This provision also requires issuers of student health insurance coverage to specify in any plan materials summarizing the terms of the coverage the AV of the coverage and the metal level (or the next lowest metal level) the coverage would otherwise satisfy under Sec. 156.140. This disclosure will provide students with information that allows them to compare the student health coverage with other available coverage options. Form Number: CMS-10377 (OMB control number 0938-1157); Frequency: Annually; Affected Public: Private Sector; Number of Respondents: 52; Total Annual Responses: 1,176,235; Total Annual Hours: 52. (For policy questions regarding this collection contact Russell Tipps at 301-492-4371.) Dated: December 6, 2018. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2018-26790 Filed 12-10-18; 8:45 am] BILLING CODE 4120-01-P
![Federal Register / Vol. 83, No. 237 / Tuesday, December 11, 2018 / Notices 63647
DEPARTMENT OF HEALTH AND To obtain copies of a supporting 2006 to measure patients’ perspectives
HUMAN SERVICES statement and any related forms for the of hospital care. While many hospitals
proposed collection(s) summarized in collect information on patient
Centers for Medicare & Medicaid this notice, you may make your request satisfaction, HCAHPS created a national
Services using one of following: standard for the collection and public
1. Access CMS’ at website address at reporting of information that enables
[Document Identifier: CMS–10102 and CMS– https://www.cms.gov/Regulations-and- valid comparisons to be made across all
10377]
Guidance/Legislation/Paperwork hospitals to support consumer choice.
Agency Information Collection ReductionActof1995/PRA-Listing.html. In the FY 2018 IPPS/LTCH PPS final
Activities: Proposed Collection; 2. Email your request, including your rule (82 FR 38328 through 38342), out
Comment Request address, phone number, OMB number, of an abundance of caution, in the face
and CMS document identifier, to of a nationwide epidemic of opioid over
AGENCY: Centers for Medicare & Paperwork@cms.hhs.gov. prescription, we finalized a refinement
Medicaid Services, HHS. 3. Call the Reports Clearance Office at to the HCAHPS Survey measure as used
ACTION: Notice. (410) 786–1326. in the Hospital Inpatient Quality
FOR FURTHER INFORMATION CONTACT: Reporting Program by removing the
SUMMARY: The Centers for Medicare & Reports Clearance Office at (410) 786– previously adopted Pain Management
Medicaid Services (CMS) is announcing 4669. questions and incorporating new
an opportunity for the public to Communication About Pain questions
SUPPLEMENTARY INFORMATION:
comment on CMS’ intention to collect beginning with patients discharged in
information from the public. Under the Contents January 2018. As discussed in the CY
Paperwork Reduction Act of 1995 (the This notice sets out a summary of the 2019 OPPS/ASC proposed rule (83 FR
PRA), federal agencies are required to use and burden associated with the 37218), since finalization of the
publish notice in the Federal Register following information collections. More Communication About Pain questions,
concerning each proposed collection of we have received feedback that some
detailed information can be found in
information (including each proposed stakeholders are concerned that,
each collection’s supporting statement
extension or reinstatement of an existing although the revised questions focus on
and associated materials (see
collection of information) and to allow communications with patients about
ADDRESSES).
60 days for public comment on the their pain and treatment of that pain,
CMS–10102 National Implementation rather than how well their pain was
proposed action. Interested persons are
of the Hospital CAHPS Survey controlled, the questions still could
invited to send comments regarding our CMS–10377 Student Health Insurance
burden estimates or any other aspect of potentially impose pressure on hospital
Coverage staff to prescribe more opioids in order
this collection of information, including
the necessity and utility of the proposed Under the PRA (44 U.S.C. 3501– to achieve higher scores on the HCAHPS
information collection for the proper 3520), federal agencies must obtain Survey.
performance of the agency’s functions, approval from the Office of Management In response to stakeholder feedback,
the accuracy of the estimated burden, and Budget (OMB) for each collection of recommendations from the President’s
ways to enhance the quality, utility, and information they conduct or sponsor. Commission on Combatting Drug
clarity of the information to be The term ‘‘collection of information’’ is Addiction and the Opioid Crisis, to
collected, and the use of automated defined in 44 U.S.C. 3502(3) and 5 CFR comply with the requirements of the
collection techniques or other forms of 1320.3(c) and includes agency requests Substance Use-Disorder Prevention that
information technology to minimize the or requirements that members of the Promotes Opioid Recovery and
information collection burden. public submit reports, keep records, or Treatment (SUPPORT) for Patients and
provide information to a third party. Communities Act (Pub. L. 115–271), and
DATES: Comments must be received by Section 3506(c)(2)(A) of the PRA to avoid any potential unintended
February 11, 2019. requires federal agencies to publish a consequences under the Hospital
ADDRESSES: When commenting, please 60-day notice in the Federal Register Inpatient Quality Reporting (IQR)
reference the document identifier or concerning each proposed collection of Program, CMS is revising the HCAHPS
OMB control number. To be assured information, including each proposed survey by removing the three recently
consideration, comments and extension or reinstatement of an existing revised pain communication questions.
recommendations must be submitted in collection of information, before The removal of these questions is
any one of the following ways: submitting the collection to OMB for effective with October 2019 discharges.
1. Electronically. You may send your approval. To comply with this At that point, the HCAHPS Survey will
comments electronically to http:// requirement, CMS is publishing this consist of 29 questions which will
www.regulations.gov. Follow the notice. decrease the burden hours. Form
instructions for ‘‘Comment or Number: CMS–10102 (OMB control
Submission’’ or ‘‘More Search Options’’ Information Collection number 0938–0981); Frequency:
to find the information collection 1. Type of Information Collection Occasionally; Affected Public: Private
document(s) that are accepting Request: Revision of a currently sector (Business or other for-profits and
comments. approved collection; Title of Not-for-profit institutions); Number of
2. By regular mail. You may mail Information Collection: National Respondents: 4,200; Total Annual
written comments to the following Implementation of the Hospital CAHPS Responses: 3,104,200; Total Annual
amozie on DSK3GDR082PROD with NOTICES1
address: CMS, Office of Strategic Survey; Use: The HCAHPS (Hospital Hours: 379,290. (For policy questions
Operations and Regulatory Affairs, Consumer Assessment of Healthcare regarding this collection contact
Division of Regulations Development, Providers and Systems) Survey, also William Lehrman at 410–786–1037.)
Attention: Document Identifier/OMB known as the CAHPS® Hospital Survey 2. Type of Information Collection
Control Number ll, Room C4–26–05, or Hospital CAHPS®, is a standardized Request: Extension; Title of Information
7500 Security Boulevard, Baltimore, survey instrument and data collection Collection: Student Health Insurance
Maryland 21244–1850. methodology that has been in use since Coverage; Use: Under the Student
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![63648 Federal Register / Vol. 83, No. 237 / Tuesday, December 11, 2018 / Notices
Health Insurance Coverage Final Rule SUMMARY: The Food and Drug Electronic Submissions
published March 21, 2012 (77 FR Administration (FDA, the Agency, or Submit electronic comments in the
16453), student health insurance we) is announcing a public meeting following way:
coverage is a type of individual health entitled ‘‘FDA’s Proposed Current Good • Federal eRulemaking Portal:
insurance coverage provided pursuant Manufacturing Practice Policies for https://www.regulations.gov. Follow the
to a written agreement between an Outsourcing Facilities: Considerations instructions for submitting comments.
institution of higher education (as Regarding Access to Office Stock.’’ Comments submitted electronically,
defined in the Higher Education Act of Stakeholders, including healthcare including attachments, to https://
1965) and a health insurance issuer, and providers (HCPs) and medical specialty www.regulations.gov will be posted to
provided to students who are enrolled groups, have expressed concerns the docket unchanged. Because your
in that institution and their dependents. regarding the availability of certain comment will be made public, you are
The Patient Protection and Affordable compounded drug products from solely responsible for ensuring that your
Care Act; HHS Notice of Benefit and outsourcing facilities that they would comment does not include any
Payment Parameters for 2017 Final Rule like to have on-hand as in-office confidential information that you or a
provided that, for policy years supplies of non-patient-specific third party may not wish to be posted,
beginning on or after July 1, 2016, compounded drugs (‘‘office stock’’). The such as medical information, your or
student health insurance coverage is anyone else’s Social Security number, or
purpose of the public meeting is to
exempt from the actuarial value (AV) confidential business information, such
provide HCPs, outsourcing facilities,
requirements under section 1302(d) of as a manufacturing process. Please note
entities considering becoming
the Affordable Care Act, but must that if you include your name, contact
provide coverage with an AV of at least outsourcing facilities, and other
interested parties with an opportunity to information, or other information that
60 percent. This provision also requires identifies you in the body of your
issuers of student health insurance present to FDA their perspectives
concerning access to office stock from comments, that information will be
coverage to specify in any plan posted on https://www.regulations.gov.
materials summarizing the terms of the outsourcing facilities in light of FDA’s
enforcement policies as proposed in the • If you want to submit a comment
coverage the AV of the coverage and the with confidential information that you
metal level (or the next lowest metal revised draft guidance on current good
manufacturing practice (CGMP) for do not wish to be made available to the
level) the coverage would otherwise public, submit the comment as a
satisfy under § 156.140. This disclosure human drug compounding outsourcing
written/paper submission and in the
will provide students with information facilities.
manner detailed (see ‘‘Written/Paper
that allows them to compare the student Submissions’’ and ‘‘Instructions’’).
health coverage with other available DATES: The public meeting will be held
coverage options. Form Number: CMS– on May 21, 2019, from 9 a.m. to 5 p.m. Written/Paper Submissions
10377 (OMB control number 0938– Submit either electronic or written
comments on this public meeting by Submit written/paper submissions as
1157); Frequency: Annually; Affected follows:
June 21, 2019. See the SUPPLEMENTARY
Public: Private Sector; Number of • Mail/Hand Delivery/Courier (for
Respondents: 52; Total Annual INFORMATION section for registration date
written/paper submissions): Dockets
Responses: 1,176,235; Total Annual and information.
Management Staff (HFA–305), Food and
Hours: 52. (For policy questions ADDRESSES: The public meeting will be Drug Administration, 5630 Fishers
regarding this collection contact Russell held at FDA’s White Oak Campus, Lane, Rm. 1061, Rockville, MD 20852.
Tipps at 301–492–4371.) 10903 New Hampshire Ave., Bldg. 31 • For written/paper comments
Dated: December 6, 2018. Conference Center, the Great Room (Rm. submitted to the Dockets Management
William N. Parham, III, 1503), Silver Spring, MD 20993–0002. Staff, FDA will post your comment, as
Director, Paperwork Reduction Staff, Office Entrance for the public meeting well as any attachments, except for
of Strategic Operations and Regulatory participants (non-FDA employees) is information submitted, marked and
Affairs. through Building 1 where routine identified, as confidential, if submitted
[FR Doc. 2018–26790 Filed 12–10–18; 8:45 am] security check procedures will be as detailed in ‘‘Instructions.’’
BILLING CODE 4120–01–P performed. For parking and security Instructions: All submissions received
information, please refer to https:// must include Docket No. FDA–2018–N–
www.fda.gov/AboutFDA/ 4087 for ‘‘FDA’s Proposed Current Good
DEPARTMENT OF HEALTH AND WorkingatFDA/BuildingsandFacilities/ Manufacturing Practice Policies for
HUMAN SERVICES WhiteOakCampusInformation/ Outsourcing Facilities: Considerations
ucm241740.htm. Regarding Access to Office Stock.’’
Food and Drug Administration Received comments, those filed in a
You may submit comments as timely manner (see ADDRESSES), will be
[Docket No. FDA–2018–N–4087] follows. Please note that late, untimely placed in the docket and, except for
filed comments will not be considered. those submitted as ‘‘Confidential
The Food and Drug Administration’s Electronic comments must be submitted Submissions,’’ are publicly viewable at
Proposed Current Good Manufacturing on or before June 21, 2019. The https:// https://www.regulations.gov or at the
Practice Policies for Outsourcing www.regulations.gov electronic filing Dockets Management Staff between 9
Facilities: Considerations Regarding system will accept comments until a.m. and 4 p.m., Monday through
amozie on DSK3GDR082PROD with NOTICES1
Access to Office Stock; Public 11:59 p.m. Eastern Time at the end of Friday.
Meeting; Request for Comments June 21, 2019. Comments received by • Confidential Submissions—To
AGENCY: Food and Drug Administration, mail/hand delivery/courier (for written/ submit a comment with confidential
HHS. paper submissions) will be considered information that you do not wish to be
timely if they are postmarked or the made publicly available, submit your
ACTION: Notice of public meeting;
delivery service acceptance receipt is on comments only as a written/paper
request for comments.
or before that date. submission. You should submit two
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Document Created: 2018-12-11 01:07:04
Document Modified: 2018-12-11 01:07:04
| 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 February 11, 2019. | |
| Contact | Reports Clearance Office at (410) 786- 4669. | |
| FR Citation | 83 FR 63647 |
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