Agency Information Collection Activities: Submission for OMB Review; Comment Request, 16270-16271 [2013-05802]

Download as PDF 16270 Federal Register / Vol. 78, No. 50 / Thursday, March 14, 2013 / Notices ESTIMATED ANNUALIZED BURDEN HOURS—Continued Number of respondents Type of respondent Form name Laboratorians .................... National Laboratory Training Network Registration Form (Attachment 3). Dated: March 7, 2013. Ron A. Otten, Director, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. [FR Doc. 2013–05821 Filed 3–13–13; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier CMS–484, CMS–10152, CMS–10449] Agency Information Collection Activities: Submission for OMB Review; Comment Request Centers for Medicare & Medicaid Services, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services (CMS) is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this 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. 1. Type of Information Collection Request: Reinstatement of a previously approved collection; Title: Attending Physician’s Certification of Medical Necessity for Home Oxygen Therapy and Supporting Documentation Requirements; Use: Under Section 1862(a)(1)(A) of the Social Security Act (the Act), 42 U.S.C. 1395y(a), the Secretary may only pay for items and services that are ‘‘reasonable and necessary for the diagnosis or treatment tkelley on DSK3SPTVN1PROD with NOTICES AGENCY: VerDate Mar<15>2010 16:51 Mar 13, 2013 Jkt 229001 of illness or injury or to improve the functioning of a malformed body member.’’ In order to assure this, CMS and its contractors develop Medical policies that specify the circumstances under which an item or service can be covered. The certificate of medical necessity (CMN) provides a mechanism for suppliers of Durable Medical Equipment, defined in 42 U.S.C. 1395x (n), and Medical Equipment and Supplies defined in 42 U.S.C. 1395j(5), to demonstrate that the item being provided meets the criteria for Medicare coverage. Section 1833(e), 42 U.S.C. 1395l(e), provides that no payment can be made to any provider of services, or other person, unless that person has furnished the information necessary for Medicare or its contractor to determine the amounts due to be paid. Certain individuals can use a CMN to furnish this information, rather than having to produce large quantities of medical records for every claim they submit for payment. Under Section 1834(j)(2) of the Act, 42 U.S.C. 1395m(j)(2), suppliers of DME items are prohibited from providing medical information to physicians when a CMN is being completed to document medical necessity. The physician who orders the item is responsible for providing the information necessary to demonstrate that the item provided is reasonable and necessary and the supplier shall also list on the CMN the fee schedule amount and the suppliers charge for the medical equipment or supplies being furnished prior to distribution of such certificate to the physician. Any supplier of medical equipment who knowingly and willfully distributes a CMN in violation of this restriction is subject to penalties, including civil money penalties (42 U.S.C. 1395m(j)(2)(A)(iii)). Under title 42 of the Code of Federal Regulations, §§ 410.38 and 424.5, Medicare has the legal authority to collect sufficient information to determine payment for oxygen, and oxygen equipment. Oxygen and oxygen equipment is by far the largest single total charge of all items paid under durable medical equipment coverage authority. Detailed criteria concerning coverage of home oxygen therapy are found in Medicare Carriers Manual Chapter II—Coverage Issues PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 Number of responses per respondent 6,500 1 Average burden per response (hours) 5/60 Appendix, Section 60–4. For Medicare to consider any item for coverage and payment, the information submitted by the supplier (e.g., claims and CMNs), including documentation in the patient’s medical records must corroborate that the patient meets Medicare coverage criteria. The patient’s medical records may include: physician’s office records; hospital records; nursing home records; home health agency records; records from other healthcare professionals or test reports. This documentation must be available to the DME MACs upon request. Form Number: CMS–484 (OCN: 0938–0534); Frequency: Occasionally; Affected Public: Private Sector: Business or other for-profits, Not-for-profits; Number of Respondents: 8,880; Total Annual Responses: 1,541,359; Total Annual Hours: 308,271. (For policy questions regarding this collection contact Doris Jackson at 410–786–4459. For all other issues call 410–786–1326.) 2. Type of Information Collection Request: Reinstatement of a previously approved collection; Title: Data Collection for Medicare Beneficiaries Receiving NaF–18 Positron Emission Tomography (PET) to Identify Bone Metastasis in Cancer; Use: In Decision Memorandum #CAG–00065R, issued on February 26, 2010, the Centers for Medicare and Medicaid Services (CMS) determined that the evidence is sufficient to conclude that for Medicare beneficiaries receiving NaF–18 PET scan to identify bone metastasis in cancer is reasonable and necessary only when the provider is participating in and patients are enrolled in a clinical study designed to information at the time of the scan to assist in initial antitumor treatment planning or to guide subsequent treatment strategy by the identification, location and quantification of bone metastases in beneficiaries in whom bone metastases are strongly suspected based on clinical symptoms or the results of other diagnostic studies. Qualifying clinical studies must ensure that specific hypotheses are addressed; appropriate data elements are collected; hospitals and providers are qualified to provide the PET scan and interpret the results; participating hospitals and providers accurately report data on all E:\FR\FM\14MRN1.SGM 14MRN1 tkelley on DSK3SPTVN1PROD with NOTICES Federal Register / Vol. 78, No. 50 / Thursday, March 14, 2013 / Notices Medicare enrolled patients; and all patient confidentiality, privacy, and other Federal laws must be followed. Consistent with section 1142 of the Social Security Act (the Act), the Agency for Healthcare Research and Quality (AHRQ) supports clinical research studies that CMS determines meets specified standards and address the specified research questions. To qualify for payment, providers must prescribe certain NaF–18 PET scans for beneficiaries with a set of clinical criteria specific to each solid tumor. The statuary authority for this policy is section 1862(a)(1)(E) of the Act. The need to prospectively collect information at the time of the scan is to assist the provider in decision making for patient management. Form Number: CMS–10152 (OCN: 0938–0968); Frequency: Annual; Affected Public: Private Sector—Business or other forprofits; Number of Respondents: 25000; Total Annual Responses: 25000; Total Annual Hours: 2,084 hours. (For policy questions regarding this collection contact Stuart Caplan at 410–786–8564. For all other issues call 410–786–1326.) 3. Type of Information Collection Request: Revision; Title of Information Collection: Recognized Accrediting Entities Data Collection; Use: The final rule that was released on July 20, 2012 (77 FR 42658) establishes a process for recognizing accrediting entities for the purposes of implementing section 1311(c)(1)(D)(i) of the Affordable Care Act. In order for a health plan to be certified as a QHP and operate in an Exchange, it must be accredited by an accrediting entity that has been recognized by the Secretary of Health and Human Services. The final rule establishes the first phase of a twophased process for recognition of accrediting entities. In phase one, the National Committee for Quality Assurance (NCQA) and URAC were recognized as accrediting entities for the purposes of fulfilling the accreditation requirement as part of qualified health plan certification. In a subsequent final rule, released February 22, 2013, we amended the first phase of this process to allow additional accrediting entities to apply to be recognized. The assessment used to assess these additional accrediting entities will be the same as the assessment underlying the recognition of NCQA and URAC. This information collection is necessary to ensure that the recognized accrediting entities meet the proposed conditions. 45 CFR 156.275(c) requires that the accrediting entities provide accreditation survey data elements, including accreditation status, VerDate Mar<15>2010 16:51 Mar 13, 2013 Jkt 229001 accreditation score, accreditation expiration date, clinical quality measure results and adult and child CAHPS measure survey results to the Exchanges once these data are released by the issuers. Further, accrediting entities applying to be recognized must provide to HHS the accreditation standards and requirements, processes, and measure specifications for performance measures and, once recognized, any proposed changes or updates to these standards, and requirements, processes and measure specifications with 60-day notice prior to public notification. This collection, which is approved under OCN: 0938–1176), is necessary in order for Exchanges to verify that the QHPs being offered in their Exchange meet the accreditation requirement and are high quality plans. The 60-day Federal Register notice published on November 23, 2012 (77 FR 70163). We received two comments. The comments concerned issuer burden associated with the data collection and the content of the data submission. These comments were addressed in full in the Patient Protection and Affordable Care Act; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation Final Rule. Generally, we noted that this data collection pertained to the submission of data from accrediting entities seeking to be recognized and accrediting entities already recognized, rather than issuers. Comments related to the content of the data submission were deemed out of scope. Form Number: CMS–10449; Frequency: Monthly, Occasionally; Affected Public: Private sector, Not-forprofit institutions; Number of Respondents: 4; Number of Responses: 60; Total Annual Hours: 3,544. (For policy questions regarding this collection contact Rebecca Zimmermann at (301) 492–4396. For all other issues, call (410) 786–1326.) To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS’ Web Site address at http://www.cms.hhs.gov/ PaperworkReductionActof1995, or Email your request, including your address, phone number, OMB number, and CMS document identifier, to Paperwork@cms.hhs.gov, or call the Reports Clearance Office on (410) 786– 1326. To be assured consideration, comments and recommendations for the proposed information collections must be received by the OMB desk officer at the address below, no later than 5 p.m. on April 15, 2013: OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 16271 Number: (202) 395–6974, Email: OIRA_submission@omb.eop.gov. Dated: March 8, 2013. Martique Jones, Deputy Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2013–05802 Filed 3–13–13; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0001] Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committees: Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee. General Function of the Committees: To provide advice and recommendations to the Agency on FDA’s regulatory issues. Date and Time: The meeting will be held on April 18, 2013, from 8 a.m. to 5 p.m. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993–0002. Information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: http://www.fda.gov/ AdvisoryCommittees/default.htm; under the heading ‘‘Resources for You,’’ click on ‘‘Public Meetings at the FDA White Oak Campus.’’ Please note that visitors to the White Oak Campus must enter through Building 1. Contact Person: Kalyani Bhatt, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 2417, Silver Spring, MD 20993–0002, 301– 796–9001, Fax: 301–847–8533, email: ACRHD@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously E:\FR\FM\14MRN1.SGM 14MRN1

Agencies

[Federal Register Volume 78, Number 50 (Thursday, March 14, 2013)]
[Notices]
[Pages 16270-16271]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-05802]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier CMS-484, CMS-10152, CMS-10449]


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

AGENCY: Centers for Medicare & Medicaid Services, HHS.
    In compliance with the requirement of section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid 
Services (CMS) is publishing the following summary of proposed 
collections for public comment. Interested persons are invited to send 
comments regarding this 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.
    1. Type of Information Collection Request: Reinstatement of a 
previously approved collection; Title: Attending Physician's 
Certification of Medical Necessity for Home Oxygen Therapy and 
Supporting Documentation Requirements; Use: Under Section 1862(a)(1)(A) 
of the Social Security Act (the Act), 42 U.S.C. 1395y(a), the Secretary 
may only pay for items and services that are ``reasonable and necessary 
for the diagnosis or treatment of illness or injury or to improve the 
functioning of a malformed body member.'' In order to assure this, CMS 
and its contractors develop Medical policies that specify the 
circumstances under which an item or service can be covered. The 
certificate of medical necessity (CMN) provides a mechanism for 
suppliers of Durable Medical Equipment, defined in 42 U.S.C. 1395x (n), 
and Medical Equipment and Supplies defined in 42 U.S.C. 1395j(5), to 
demonstrate that the item being provided meets the criteria for 
Medicare coverage. Section 1833(e), 42 U.S.C. 1395l(e), provides that 
no payment can be made to any provider of services, or other person, 
unless that person has furnished the information necessary for Medicare 
or its contractor to determine the amounts due to be paid. Certain 
individuals can use a CMN to furnish this information, rather than 
having to produce large quantities of medical records for every claim 
they submit for payment. Under Section 1834(j)(2) of the Act, 42 U.S.C. 
1395m(j)(2), suppliers of DME items are prohibited from providing 
medical information to physicians when a CMN is being completed to 
document medical necessity. The physician who orders the item is 
responsible for providing the information necessary to demonstrate that 
the item provided is reasonable and necessary and the supplier shall 
also list on the CMN the fee schedule amount and the suppliers charge 
for the medical equipment or supplies being furnished prior to 
distribution of such certificate to the physician. Any supplier of 
medical equipment who knowingly and willfully distributes a CMN in 
violation of this restriction is subject to penalties, including civil 
money penalties (42 U.S.C. 1395m(j)(2)(A)(iii)). Under title 42 of the 
Code of Federal Regulations, Sec. Sec.  410.38 and 424.5, Medicare has 
the legal authority to collect sufficient information to determine 
payment for oxygen, and oxygen equipment. Oxygen and oxygen equipment 
is by far the largest single total charge of all items paid under 
durable medical equipment coverage authority. Detailed criteria 
concerning coverage of home oxygen therapy are found in Medicare 
Carriers Manual Chapter II--Coverage Issues Appendix, Section 60-4. For 
Medicare to consider any item for coverage and payment, the information 
submitted by the supplier (e.g., claims and CMNs), including 
documentation in the patient's medical records must corroborate that 
the patient meets Medicare coverage criteria. The patient's medical 
records may include: physician's office records; hospital records; 
nursing home records; home health agency records; records from other 
healthcare professionals or test reports. This documentation must be 
available to the DME MACs upon request. Form Number: CMS-484 (OCN: 
0938-0534); Frequency: Occasionally; Affected Public: Private Sector: 
Business or other for-profits, Not-for-profits; Number of Respondents: 
8,880; Total Annual Responses: 1,541,359; Total Annual Hours: 308,271. 
(For policy questions regarding this collection contact Doris Jackson 
at 410-786-4459. For all other issues call 410-786-1326.)
    2. Type of Information Collection Request: Reinstatement of a 
previously approved collection; Title: Data Collection for Medicare 
Beneficiaries Receiving NaF-18 Positron Emission Tomography (PET) to 
Identify Bone Metastasis in Cancer; Use: In Decision Memorandum 
CAG-00065R, issued on February 26, 2010, the Centers for 
Medicare and Medicaid Services (CMS) determined that the evidence is 
sufficient to conclude that for Medicare beneficiaries receiving NaF-18 
PET scan to identify bone metastasis in cancer is reasonable and 
necessary only when the provider is participating in and patients are 
enrolled in a clinical study designed to information at the time of the 
scan to assist in initial antitumor treatment planning or to guide 
subsequent treatment strategy by the identification, location and 
quantification of bone metastases in beneficiaries in whom bone 
metastases are strongly suspected based on clinical symptoms or the 
results of other diagnostic studies. Qualifying clinical studies must 
ensure that specific hypotheses are addressed; appropriate data 
elements are collected; hospitals and providers are qualified to 
provide the PET scan and interpret the results; participating hospitals 
and providers accurately report data on all

[[Page 16271]]

Medicare enrolled patients; and all patient confidentiality, privacy, 
and other Federal laws must be followed. Consistent with section 1142 
of the Social Security Act (the Act), the Agency for Healthcare 
Research and Quality (AHRQ) supports clinical research studies that CMS 
determines meets specified standards and address the specified research 
questions. To qualify for payment, providers must prescribe certain 
NaF-18 PET scans for beneficiaries with a set of clinical criteria 
specific to each solid tumor. The statuary authority for this policy is 
section 1862(a)(1)(E) of the Act. The need to prospectively collect 
information at the time of the scan is to assist the provider in 
decision making for patient management. Form Number: CMS-10152 (OCN: 
0938-0968); Frequency: Annual; Affected Public: Private Sector--
Business or other for-profits; Number of Respondents: 25000; Total 
Annual Responses: 25000; Total Annual Hours: 2,084 hours. (For policy 
questions regarding this collection contact Stuart Caplan at 410-786-
8564. For all other issues call 410-786-1326.)
    3. Type of Information Collection Request: Revision; Title of 
Information Collection: Recognized Accrediting Entities Data 
Collection; Use: The final rule that was released on July 20, 2012 (77 
FR 42658) establishes a process for recognizing accrediting entities 
for the purposes of implementing section 1311(c)(1)(D)(i) of the 
Affordable Care Act. In order for a health plan to be certified as a 
QHP and operate in an Exchange, it must be accredited by an accrediting 
entity that has been recognized by the Secretary of Health and Human 
Services. The final rule establishes the first phase of a two-phased 
process for recognition of accrediting entities. In phase one, the 
National Committee for Quality Assurance (NCQA) and URAC were 
recognized as accrediting entities for the purposes of fulfilling the 
accreditation requirement as part of qualified health plan 
certification. In a subsequent final rule, released February 22, 2013, 
we amended the first phase of this process to allow additional 
accrediting entities to apply to be recognized. The assessment used to 
assess these additional accrediting entities will be the same as the 
assessment underlying the recognition of NCQA and URAC. This 
information collection is necessary to ensure that the recognized 
accrediting entities meet the proposed conditions. 45 CFR 156.275(c) 
requires that the accrediting entities provide accreditation survey 
data elements, including accreditation status, accreditation score, 
accreditation expiration date, clinical quality measure results and 
adult and child CAHPS measure survey results to the Exchanges once 
these data are released by the issuers. Further, accrediting entities 
applying to be recognized must provide to HHS the accreditation 
standards and requirements, processes, and measure specifications for 
performance measures and, once recognized, any proposed changes or 
updates to these standards, and requirements, processes and measure 
specifications with 60-day notice prior to public notification. This 
collection, which is approved under OCN: 0938-1176), is necessary in 
order for Exchanges to verify that the QHPs being offered in their 
Exchange meet the accreditation requirement and are high quality plans.
    The 60-day Federal Register notice published on November 23, 2012 
(77 FR 70163). We received two comments. The comments concerned issuer 
burden associated with the data collection and the content of the data 
submission. These comments were addressed in full in the Patient 
Protection and Affordable Care Act; Standards Related to Essential 
Health Benefits, Actuarial Value, and Accreditation Final Rule. 
Generally, we noted that this data collection pertained to the 
submission of data from accrediting entities seeking to be recognized 
and accrediting entities already recognized, rather than issuers. 
Comments related to the content of the data submission were deemed out 
of scope. Form Number: CMS-10449; Frequency: Monthly, Occasionally; 
Affected Public: Private sector, Not-for-profit institutions; Number of 
Respondents: 4; Number of Responses: 60; Total Annual Hours: 3,544. 
(For policy questions regarding this collection contact Rebecca 
Zimmermann at (301) 492-4396. For all other issues, call (410) 786-
1326.)
    To obtain copies of the supporting statement and any related forms 
for the proposed paperwork collections referenced above, access CMS' 
Web Site address at http://www.cms.hhs.gov/PaperworkReductionActof1995, 
or Email your request, including your address, phone number, OMB 
number, and CMS document identifier, to Paperwork@cms.hhs.gov, or call 
the Reports Clearance Office on (410) 786-1326.
    To be assured consideration, comments and recommendations for the 
proposed information collections must be received by the OMB desk 
officer at the address below, no later than 5 p.m. on April 15, 2013: 
OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk 
Officer, Fax Number: (202) 395-6974, Email: OIRA_submission@omb.eop.gov.

    Dated: March 8, 2013.
Martique Jones,
Deputy Director, Regulations Development Group, Office of Strategic 
Operations and Regulatory Affairs.
[FR Doc. 2013-05802 Filed 3-13-13; 8:45 am]
BILLING CODE 4120-01-P