81 FR 69828 - Agency Information Collection Activities: Submission for OMB Review; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 81, Issue 195 (October 7, 2016)
Centers for Medicare & Medicaid Services
Federal Register Volume 81, Issue 195 (October 7, 2016)
| Page Range | 69828-69829 | |
| FR Document | 2016-24341 |
[Federal Register Volume 81, Number 195 (Friday, October 7, 2016)] [Notices] [Pages 69828-69829] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-24341] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifiers: CMS-10605, CMS-R-5, CMS-10311, and CMS-10242] Agency Information Collection Activities: Submission for OMB Review; 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 (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 any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. DATES: Comments on the collection(s) of information must be received by the OMB desk officer by November 7, 2016. ADDRESSES: When commenting on the proposed information collections, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be received by the OMB desk officer via one of the following transmissions: OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: (202) 395-5806, OR Email: OIRA_submission@omb.eop.gov. 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 the following: 1. Access CMS' Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995. 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: Reports Clearance Office at (410) 786- 1326. SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 (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 (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-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 that summarizes the following proposed collection(s) of information for public comment: 1. Type of Information Collection Request: New collection (Request for a new OMB control number); Title of Information Collection: The Health Insurance Enforcement and Consumer Protections Grant Program; Use: Section 1003 of the Affordable Care Act (ACA) adds a new section 2794 to the PHS Act entitled, ``Ensuring That Consumers Get Value for Their Dollars.'' Specifically, section 2794(a) requires the Secretary of the Department of Health and Human Services (the Secretary) (HHS), in conjunction with the States, to establish a process for the annual review of health insurance premiums to protect consumers from unreasonable rate increases. Section 2794(c) directs the Secretary to carry out a program to award grants to States. Section 2794(c)(2)(B) specifies that any appropriated Rate Review Grant funds that are not fully obligated by the end of FY 2014 shall remain available to the Secretary for grants to States for planning and implementing the insurance market reforms and consumer protections under Part A of title XXVII of the Public Health Service Act (PHS Act). States that apply for funds are required to complete the grant application. States that are awarded funds under this funding opportunity are required to provide the CMS with four quarterly reports, and one annual report per year (except for the last year of the grant) until the end of the grant period detailing the state's progression towards planning and/or implementing the market reforms under Part A of Title XXVII of the PHS Act. A final report is due at the end of the grant period. Form Number: CMS-10605 (OMB control number: 0938--NEW); Frequency: Annually and Quarterly; Affected Public: State, Local or Tribal Governments; Number of Respondents: 23; Total Annual Responses: 115; Total Annual Hours: 2,898. (For policy questions regarding this collection contact Jim Taing at 301-492-4182.) 2. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Physician Certification/Recertification in Skilled Nursing Facilities (SNFs) Manual Instructions; Use: Section 1814(a) of the Social Security Act (the Act) requires specific certifications in order for Medicare payments to be made for certain services. Before the enactment of the Omnibus Budget Reconciliation Act of 1989 (OBRA1989, Public Law 101- 239), section 1814(a)(2) of the Act required that, in the case of post hospital extended care services, a physician certify that the services are or were required to be given because the individual needs or needed, on a daily basis, skilled nursing care (provided directly by or requiring the supervision of skilled nursing personnel) or other skilled rehabilitation services that, as a practical matter, can only be provided in a SNF on an inpatient basis. The [[Page 69829]] physician certification requirements were included in the law to ensure that patients require a level of care that is covered by the Medicare program and because the physician is a key figure in determining the utilization of health services. Form Number: CMS-R-5 (OMB control number: 0938-0454); Frequency: Occasionally; Affected Public: Business or other for-profits and Not-for-profit institutions; Number of Respondents: 2,711,136; Total Annual Responses: 2,711,136; Total Annual Hours: 624,515. (For policy questions regarding this collection contact Kia Sidbury at 410-786-7816.) 3. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Medicare Program/ Home Health Prospective Payment System Rate Update for Calendar Year 2010: Physician Narrative Requirement and Supporting Regulation; Use: Section (o) of the Act (42 U.S.C. 1395x) specifies certain requirements that a home health agency must meet to participate in the Medicare program. To qualify for Medicare coverage of home health services a Medicare beneficiary must meet each of the following requirements as stipulated in Sec. 409.42: Be confined to the home or an institution that is not a hospital, SNF, or nursing facility as defined in sections 1861(e)(1), 1819(a)(1) or 1919 of Act; be under the care of a physician as described in Sec. 409.42(b); be under a plan of care that meets the requirements specified in Sec. 409.43; the care must be furnished by or under arrangements made by a participating HHA, and the beneficiary must be in need of skilled services as described in Sec. 409.42(c). Subsection 409.42(c) of our regulations requires that the beneficiary need at least one of the following services as certified by a physician in accordance with Sec. 424.22: Intermittent skilled nursing services and the need for skilled services which meet the criteria in Sec. 409.32; Physical therapy which meets the requirements of Sec. 409.44(c), Speech-language pathology which meets the requirements of Sec. 409.44(c); or have a continuing need for occupational therapy that meets the requirements of Sec. 409.44(c), subject to the limitations described in Sec. 409.42(c)(4). On March 23, 2010, the Affordable Care Act of 2010 (Pub. L. 111-148) was enacted. Section 6407(a) (amended by section 10605) of the Affordable Care Act amends the requirements for physician certification of home health services contained in Sections 1814(a)(2)(C) and 1835(a)(2)(A) by requiring that, prior to certifying a patient as eligible for Medicare's home health benefit, the physician must document that the physician himself or herself or a permitted non-physician practitioner has had a face-to- face encounter (including through the use of tele-health services, subject to the requirements in section 1834(m) of the Act)'', with the patient. The Affordable Care Act provision does not amend the statutory requirement that a physician must certify a patient's eligibility for Medicare's home health benefit, (see Sections 1814(a)(2)(C) and 1835(a)(2)(A) of the Act. Form Number: CMS-10311 (OMB control number: 0938-1083); Frequency: Yearly; Affected Public: Business or other for- profits; Number of Respondents: 345,600; Total Annual Responses: 345,600; Total Annual Hours: 28,800. (For policy questions regarding this collection contact Hillary Loeffler at 410-786-0456.) 4. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Documentation Requirements Concerning Emergency and Nonemergency Ambulance Transports Described in the Beneficiary Signature Regulations in 42 CFR 424.36(b); Use: The statutory authority requiring a beneficiary's signature on a claim submitted by a provider is located in section 1835(a) and in 1814(a) of the Social Security Act (the Act), for Part B and Part A services, respectively. The authority requiring a beneficiary's signature for supplier claims is implicit in sections 1842(b)(3)(B)(ii) and in 1848(g)(4) of the Act. Federal regulations at 42 CFR 424.32(a)(3) state that all claims must be signed by the beneficiary or on behalf of the beneficiary (in accordance with 424.36). Section 424.36(a) states that the beneficiary's signature is required on a claim unless the beneficiary has died or the provisions of 424.36(b), (c), or (d) apply. We believe that for emergency and nonemergency ambulance transport services, where the beneficiary is physically or mentally incapable of signing the claim (and the beneficiary's authorized representative is unavailable or unwilling to sign the claim), that it is impractical and infeasible to require an ambulance provider or supplier to later locate the beneficiary or the person authorized to sign on behalf of the beneficiary, before submitting the claim to Medicare for payment. Therefore, we created an exception to the beneficiary signature requirement with respect to emergency and nonemergency ambulance transport services, where the beneficiary is physically or mentally incapable of signing the claim, and if certain documentation requirements are met. Thus, we added subsection (6) to paragraph (b) of 42 CFR 424.36. The information required in this ICR is needed to help ensure that services were in fact rendered and were rendered as billed. Form Number: CMS-10242 (OMB control number: 0938- 1049); Frequency: Yearly; Affected Public: Business or other for- profits, Not-for-profit institutions); Number of Respondents: 10,402; Total Annual Responses: 14,155,617; Total Annual Hours: 1,180,578. (For policy questions regarding this collection contact Martha Kuespert at 410-786-4605.) Dated: October 4, 2016. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2016-24341 Filed 10-6-16; 8:45 am] BILLING CODE 4120-01-P
![69828 Federal Register / Vol. 81, No. 195 / Friday, October 7, 2016 / Notices
includes questions at the beginning of technology to minimize the information entitled, ‘‘Ensuring That Consumers Get
the interview that will capture the age, collection burden. Value for Their Dollars.’’ Specifically,
sex, active duty military status, race, DATES: Comments on the collection(s) of section 2794(a) requires the Secretary of
and ethnicity of everyone who usually information must be received by the the Department of Health and Human
lives or stays in the household. Some OMB desk officer by November 7, 2016. Services (the Secretary) (HHS), in
content from the family questionnaire ADDRESSES: When commenting on the conjunction with the States, to establish
(e.g., family income, financial burden of proposed information collections, a process for the annual review of health
medical care, housing tenure) will be please reference the document identifier insurance premiums to protect
moved into the two remaining or OMB control number. To be assured consumers from unreasonable rate
questionnaires. consideration, comments and increases. Section 2794(c) directs the
Public comment on the first draft of recommendations must be received by Secretary to carry out a program to
these questionnaires will be critical as the OMB desk officer via one of the award grants to States. Section
we continue to revise and improve the following transmissions: OMB, Office of 2794(c)(2)(B) specifies that any
content and question text during the Information and Regulatory Affairs, appropriated Rate Review Grant funds
redesign process. The first draft of the Attention: CMS Desk Officer, Fax that are not fully obligated by the end
questionnaires may be found in the Number: (202) 395–5806, OR Email: of FY 2014 shall remain available to the
docket under Supporting and Related OIRA_submission@omb.eop.gov. Secretary for grants to States for
Materials. To obtain copies of a supporting planning and implementing the
Dated: October 4, 2016. statement and any related forms for the insurance market reforms and consumer
Sandra Cashman, proposed collection(s) summarized in protections under Part A of title XXVII
Executive Secretary, Centers for Disease this notice, you may make your request of the Public Health Service Act (PHS
Control and Prevention. using one of the following: Act). States that apply for funds are
[FR Doc. 2016–24348 Filed 10–6–16; 8:45 am] 1. Access CMS’ Web site address at required to complete the grant
BILLING CODE 4163–18–P http://www.cms.hhs.gov/ application. States that are awarded
PaperworkReductionActof1995. funds under this funding opportunity
2. Email your request, including your are required to provide the CMS with
DEPARTMENT OF HEALTH AND address, phone number, OMB number, four quarterly reports, and one annual
HUMAN SERVICES and CMS document identifier, to report per year (except for the last year
Paperwork@cms.hhs.gov. of the grant) until the end of the grant
Centers for Medicare & Medicaid 3. Call the Reports Clearance Office at period detailing the state’s progression
Services (410) 786–1326. towards planning and/or implementing
[Document Identifiers: CMS–10605, CMS– FOR FURTHER INFORMATION CONTACT: the market reforms under Part A of Title
R–5, CMS–10311, and CMS–10242] Reports Clearance Office at (410) 786– XXVII of the PHS Act. A final report is
1326. due at the end of the grant period. Form
Agency Information Collection SUPPLEMENTARY INFORMATION: Under the Number: CMS–10605 (OMB control
Activities: Submission for OMB Paperwork Reduction Act of 1995 (PRA) number: 0938—NEW); Frequency:
Review; Comment Request (44 U.S.C. 3501–3520), federal agencies Annually and Quarterly; Affected
must obtain approval from the Office of Public: State, Local or Tribal
AGENCY: Centers for Medicare &
Management and Budget (OMB) for each Governments; Number of Respondents:
Medicaid Services, HHS.
collection of information they conduct 23; Total Annual Responses: 115; Total
ACTION: Notice.
or sponsor. The term ‘‘collection of Annual Hours: 2,898. (For policy
SUMMARY: The Centers for Medicare & information’’ is defined in 44 U.S.C. questions regarding this collection
Medicaid Services (CMS) is announcing 3502(3) and 5 CFR 1320.3(c) and contact Jim Taing at 301–492–4182.)
an opportunity for the public to includes agency requests or 2. Type of Information Collection
comment on CMS’ intention to collect requirements that members of the public Request: Extension of a currently
information from the public. Under the submit reports, keep records, or provide approved collection; Title of
Paperwork Reduction Act of 1995 information to a third party. Section Information Collection: Physician
(PRA), federal agencies are required to 3506(c)(2)(A) of the PRA (44 U.S.C. Certification/Recertification in Skilled
publish notice in the Federal Register 3506(c)(2)(A)) requires federal agencies Nursing Facilities (SNFs) Manual
concerning each proposed collection of to publish a 30-day notice in the Instructions; Use: Section 1814(a) of the
information, including each proposed Federal Register concerning each Social Security Act (the Act) requires
extension or reinstatement of an existing proposed collection of information, specific certifications in order for
collection of information, and to allow including each proposed extension or Medicare payments to be made for
a second opportunity for public reinstatement of an existing collection certain services. Before the enactment of
comment on the notice. Interested of information, before submitting the the Omnibus Budget Reconciliation Act
persons are invited to send comments collection to OMB for approval. To of 1989 (OBRA1989, Public Law 101–
regarding the burden estimate or any comply with this requirement, CMS is 239), section 1814(a)(2) of the Act
other aspect of this collection of publishing this notice that summarizes required that, in the case of post
information, including any of the the following proposed collection(s) of hospital extended care services, a
following subjects: (1) The necessity and information for public comment: physician certify that the services are or
utility of the proposed information 1. Type of Information Collection were required to be given because the
mstockstill on DSK3G9T082PROD with NOTICES
collection for the proper performance of Request: New collection (Request for a individual needs or needed, on a daily
the agency’s functions; (2) the accuracy new OMB control number); Title of basis, skilled nursing care (provided
of the estimated burden; (3) ways to Information Collection: The Health directly by or requiring the supervision
enhance the quality, utility, and clarity Insurance Enforcement and Consumer of skilled nursing personnel) or other
of the information to be collected; and Protections Grant Program; Use: Section skilled rehabilitation services that, as a
(4) the use of automated collection 1003 of the Affordable Care Act (ACA) practical matter, can only be provided
techniques or other forms of information adds a new section 2794 to the PHS Act in a SNF on an inpatient basis. The
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![Federal Register / Vol. 81, No. 195 / Friday, October 7, 2016 / Notices 69829
physician certification requirements Medicare’s home health benefit, the certain documentation requirements are
were included in the law to ensure that physician must document that the met. Thus, we added subsection (6) to
patients require a level of care that is physician himself or herself or a paragraph (b) of 42 CFR 424.36. The
covered by the Medicare program and permitted non-physician practitioner information required in this ICR is
because the physician is a key figure in has had a face-to-face encounter needed to help ensure that services were
determining the utilization of health (including through the use of tele-health in fact rendered and were rendered as
services. Form Number: CMS–R–5 services, subject to the requirements in billed. Form Number: CMS–10242
(OMB control number: 0938–0454); section 1834(m) of the Act)’’, with the (OMB control number: 0938–1049);
Frequency: Occasionally; Affected patient. The Affordable Care Act Frequency: Yearly; Affected Public:
Public: Business or other for-profits and provision does not amend the statutory Business or other for-profits, Not-for-
Not-for-profit institutions; Number of requirement that a physician must profit institutions); Number of
Respondents: 2,711,136; Total Annual certify a patient’s eligibility for Respondents: 10,402; Total Annual
Responses: 2,711,136; Total Annual Medicare’s home health benefit, (see Responses: 14,155,617; Total Annual
Hours: 624,515. (For policy questions Sections 1814(a)(2)(C) and 1835(a)(2)(A) Hours: 1,180,578. (For policy questions
regarding this collection contact Kia of the Act. Form Number: CMS–10311 regarding this collection contact Martha
Sidbury at 410–786–7816.) (OMB control number: 0938–1083); Kuespert at 410–786–4605.)
3. Type of Information Collection Frequency: Yearly; Affected Public: Dated: October 4, 2016.
Request: Extension of a currently Business or other for-profits; Number of William N. Parham, III,
approved collection; Title of Respondents: 345,600; Total Annual Director, Paperwork Reduction Staff, Office
Information Collection: Medicare Responses: 345,600; Total Annual of Strategic Operations and Regulatory
Program/Home Health Prospective Hours: 28,800. (For policy questions Affairs.
Payment System Rate Update for regarding this collection contact Hillary [FR Doc. 2016–24341 Filed 10–6–16; 8:45 am]
Calendar Year 2010: Physician Narrative Loeffler at 410–786–0456.) BILLING CODE 4120–01–P
Requirement and Supporting 4. Type of Information Collection
Regulation; Use: Section (o) of the Act Request: Extension of a currently
(42 U.S.C. 1395x) specifies certain approved collection; Title of DEPARTMENT OF HEALTH AND
requirements that a home health agency Information Collection: Documentation HUMAN SERVICES
must meet to participate in the Medicare Requirements Concerning Emergency
program. To qualify for Medicare and Nonemergency Ambulance Food and Drug Administration
coverage of home health services a Transports Described in the Beneficiary [Docket No. FDA–2016–N–2872]
Medicare beneficiary must meet each of Signature Regulations in 42 CFR
the following requirements as stipulated 424.36(b); Use: The statutory authority Medical Device User Fee Amendments;
in § 409.42: Be confined to the home or requiring a beneficiary’s signature on a Public Meeting; Request for Comments
an institution that is not a hospital, claim submitted by a provider is located AGENCY: Food and Drug Administration,
SNF, or nursing facility as defined in in section 1835(a) and in 1814(a) of the HHS.
sections 1861(e)(1), 1819(a)(1) or 1919 of Social Security Act (the Act), for Part B
ACTION: Notice of public meeting;
Act; be under the care of a physician as and Part A services, respectively. The
request for comments.
described in § 409.42(b); be under a plan authority requiring a beneficiary’s
of care that meets the requirements signature for supplier claims is implicit SUMMARY: The Food and Drug
specified in § 409.43; the care must be in sections 1842(b)(3)(B)(ii) and in Administration (FDA) is announcing a
furnished by or under arrangements 1848(g)(4) of the Act. Federal public meeting entitled ‘‘Medical Device
made by a participating HHA, and the regulations at 42 CFR 424.32(a)(3) state User Fee Amendments.’’ The purpose of
beneficiary must be in need of skilled that all claims must be signed by the the meeting is to discuss proposed
services as described in § 409.42(c). beneficiary or on behalf of the recommendations for the
Subsection 409.42(c) of our regulations beneficiary (in accordance with 424.36). reauthorization of the Medical Device
requires that the beneficiary need at Section 424.36(a) states that the User Fee Amendments (MDUFA) for
least one of the following services as beneficiary’s signature is required on a fiscal years (FYs) 2018 through 2022.
certified by a physician in accordance claim unless the beneficiary has died or MDUFA authorizes FDA to collect fees
with § 424.22: Intermittent skilled the provisions of 424.36(b), (c), or (d) and use them for the process for the
nursing services and the need for skilled apply. We believe that for emergency review of medical device applications.
services which meet the criteria in and nonemergency ambulance transport The current legislative authority for
§ 409.32; Physical therapy which meets services, where the beneficiary is MDUFA expires October 1, 2017. At that
the requirements of § 409.44(c), Speech- physically or mentally incapable of time, new legislation will be required
language pathology which meets the signing the claim (and the beneficiary’s for FDA to continue collecting medical
requirements of § 409.44(c); or have a authorized representative is unavailable device user fees in future fiscal years.
continuing need for occupational or unwilling to sign the claim), that it Following discussions with the device
therapy that meets the requirements of is impractical and infeasible to require industry and periodic consultations
§ 409.44(c), subject to the limitations an ambulance provider or supplier to with public stakeholders, the Federal
described in § 409.42(c)(4). On March later locate the beneficiary or the person Food, Drug, and Cosmetic Act (the
23, 2010, the Affordable Care Act of authorized to sign on behalf of the FD&C Act) directs FDA to publish the
2010 (Pub. L. 111–148) was enacted. beneficiary, before submitting the claim recommendations for the reauthorized
mstockstill on DSK3G9T082PROD with NOTICES
Section 6407(a) (amended by section to Medicare for payment. Therefore, we program in the Federal Register, hold a
10605) of the Affordable Care Act created an exception to the beneficiary meeting at which the public may
amends the requirements for physician signature requirement with respect to present its views on such
certification of home health services emergency and nonemergency recommendations, and provide for a
contained in Sections 1814(a)(2)(C) and ambulance transport services, where the period of 30 days for the public to
1835(a)(2)(A) by requiring that, prior to beneficiary is physically or mentally provide written comments on such
certifying a patient as eligible for incapable of signing the claim, and if recommendations. FDA will then
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Document Created: 2018-02-13 16:31:58
Document Modified: 2018-02-13 16:31:58
| 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 on the collection(s) of information must be received by the OMB desk officer by November 7, 2016. | |
| Contact | Reports Clearance Office at (410) 786- 1326. | |
| FR Citation | 81 FR 69828 |
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