Agency Information Collection Activities: Proposed Collection; Comment Request, 47852-47853 [2012-19694]

Download as PDF 47852 Federal Register / Vol. 77, No. 155 / Friday, August 10, 2012 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier CMS–10381, CMS–484, CMS–10152 and CMS–R–290] Agency Information Collection Activities: Proposed Collection; 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: Revision of a currently approved collection; Title: ICD–10 Industry Readiness Assessment; Use: The Congress addressed the need for a consistent framework for electronic transactions and other administrative simplification issues in the Health Insurance Portability and Accountability Act of 1996 (HIPAA), Public Law 104–191, enacted on August 21, 1996. Through subtitle F of title II of HIPAA, the Congress added to title XI of the Social Security Act (the Act) a new Part C, entitled ‘‘Administrative Simplification.’’ Part C of title XI of the Act now consists of sections 1171 through 1180, which define various terms and impose several requirements on HHS, health plans, health care clearinghouses, and certain health care providers concerning the transmission of health information. Specifically, HIPAA requires the Secretary of HHS to adopt standards that covered entities are required to use in conducting certain health care administrative transactions, such as claims, remittance, eligibility, and claims status requests and responses. Findings from the ICD–10 industry readiness assessment will be used by CMS to understand each mstockstill on DSK4VPTVN1PROD with NOTICES AGENCY: VerDate Mar<15>2010 18:02 Aug 09, 2012 Jkt 226001 sector’s progress toward compliance and to determine what communication and educational efforts can best help affected entities obtain the tools and resources they need to achieve timely compliance with ICD–10. Insights gleaned from the proposed research will be valid for education and outreach purposes only, and will not be used for policy purposes. Form Number: CMS– 10381 (OCN: 0938–1149); Frequency: Annual; Affected Public: Private Sector—Business or other for-profits, Not-for-profits; Number of Respondents: 1,200; Total Annual Responses: 1,200; Total Annual Hours: 204. (For policy questions regarding this collection contact Rosali Topper at 410–786–7260. For all other issues call 410–786–1326.) 2. 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 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 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 Section 42 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 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.) 3. 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 E:\FR\FM\10AUN1.SGM 10AUN1 mstockstill on DSK4VPTVN1PROD with NOTICES Federal Register / Vol. 77, No. 155 / Friday, August 10, 2012 / Notices 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 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 Agency for Healthcare Research and Quality (AHRQ) supports clinical research studies that the CMS determines meet 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 Social Security 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: 25,000; Total Annual Responses: 25,000; Total Annual Hours: 2,084. (For policy questions regarding this collection contact Stuart Caplan at 410–786–8564. For all other issues call 410–786–1326.) 4. Type of Information Collection Request: Reinstatement of a currently approved collection; Title: Medicare Program: Procedures for Making National Coverage Decisions; Use: The Centers for Medicare & Medicaid Services (CMS) revised the April 27, 1999 (64 FR 22619) notice and published a new notice on September 26, 2003 (68 FR 55634) that described the process we use to make Medicare coverage decisions including decisions regarding whether new technology and services can be covered. We have made changes to our internal procedures in response to the comments we received following publication of the 1999 notice and experience under our new process. Over the past several years, we received numerous suggestions to further revise our process to continue to make it more open, responsive, and understandable to the public. We share the goal of increasing public participation in the development of Medicare coverage issues. This will assist us in obtaining the information we require to make a VerDate Mar<15>2010 18:02 Aug 09, 2012 Jkt 226001 national coverage determination in a timely manner and ensuring that the Medicare program continues to meet the needs of its beneficiaries. Form Number: CMS–R–290 (OCN: 0938–0776); Frequency: Annual; Affected Public: Private Sector: Business or other forprofits; Number of Respondents: 200; Total Annual Responses: 200; Total Annual Hours: 8,000. (For policy questions regarding this collection contact Katherine Tillman at 410–786– 9252. 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 https://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. In commenting on the proposed information collections please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in one of the following ways by October 9, 2012: 1. Electronically. You may submit your comments electronically to https:// www.regulations.gov. Follow the instructions for ‘‘Comment or Submission’’ or ‘‘More Search Options’’ to find the information collection document(s) 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 lll, Room C4–26– 05, 7500 Security Boulevard, Baltimore, Maryland 21244–1850. Dated: August 7, 2012. Martique Jones, Director, Regulations Development Group, Division B Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2012–19694 Filed 8–9–12; 8:45 am] BILLING CODE 4120–01–P PO 00000 47853 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0781] Request for Notification From Industry Organizations Interested in Participating in Selection Process for Nonvoting Industry Representative on the Pediatric Advisory Committee and Request for Nominations for Nonvoting Industry Representatives on the Pediatric Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Pediatric Advisory Committee for the Office of the Commissioner (OC) notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative(s) to serve on the Pediatric Advisory Committee. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice. DATES: Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests must send a letter stating that interest to FDA by September 10, 2012, for the vacancy listed in this notice. Concurrently, nomination materials for prospective candidates should be sent to FDA by September 10, 2012. ADDRESSES: All letters of interest and nominations should be submitted in writing to Walter Ellenberg (see FOR FURTHER INFORMATION CONTACT). FOR FURTHER INFORMATION CONTACT: Walter Ellenberg, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5154, Silver Spring, MD 20993, 301–796–0885, FAX: 301– 847–8640, walter.ellenberg@fda.hhs.gov. SUPPLEMENTARY INFORMATION: The Agency intends to add a nonvoting industry representative(s) to the following advisory committee: SUMMARY: I. OC Advisory Committee Pediatric Advisory Committee The Committee reviews and evaluates and makes recommendations to the Commissioner of Food and Drugs Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\10AUN1.SGM 10AUN1

Agencies

[Federal Register Volume 77, Number 155 (Friday, August 10, 2012)]
[Notices]
[Pages 47852-47853]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-19694]



[[Page 47852]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier CMS-10381, CMS-484, CMS-10152 and CMS-R-290]


Agency Information Collection Activities: Proposed Collection; 
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: Revision of a currently 
approved collection; Title: ICD-10 Industry Readiness Assessment; Use: 
The Congress addressed the need for a consistent framework for 
electronic transactions and other administrative simplification issues 
in the Health Insurance Portability and Accountability Act of 1996 
(HIPAA), Public Law 104-191, enacted on August 21, 1996. Through 
subtitle F of title II of HIPAA, the Congress added to title XI of the 
Social Security Act (the Act) a new Part C, entitled ``Administrative 
Simplification.'' Part C of title XI of the Act now consists of 
sections 1171 through 1180, which define various terms and impose 
several requirements on HHS, health plans, health care clearinghouses, 
and certain health care providers concerning the transmission of health 
information. Specifically, HIPAA requires the Secretary of HHS to adopt 
standards that covered entities are required to use in conducting 
certain health care administrative transactions, such as claims, 
remittance, eligibility, and claims status requests and responses. 
Findings from the ICD-10 industry readiness assessment will be used by 
CMS to understand each sector's progress toward compliance and to 
determine what communication and educational efforts can best help 
affected entities obtain the tools and resources they need to achieve 
timely compliance with ICD-10. Insights gleaned from the proposed 
research will be valid for education and outreach purposes only, and 
will not be used for policy purposes. Form Number: CMS-10381 (OCN: 
0938-1149); Frequency: Annual; Affected Public: Private Sector--
Business or other for-profits, Not-for-profits; Number of Respondents: 
1,200; Total Annual Responses: 1,200; Total Annual Hours: 204. (For 
policy questions regarding this collection contact Rosali Topper at 
410-786-7260. For all other issues call 410-786-1326.)
    2. 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 Section 42 Code 
of Federal Regulations Sec.  410.38 and Sec.  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.)
    3. 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

[[Page 47853]]

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 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 Agency for 
Healthcare Research and Quality (AHRQ) supports clinical research 
studies that the CMS determines meet 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 Social Security 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: 25,000; Total Annual Responses: 25,000; Total Annual 
Hours: 2,084. (For policy questions regarding this collection contact 
Stuart Caplan at 410-786-8564. For all other issues call 410-786-1326.)
    4. Type of Information Collection Request: Reinstatement of a 
currently approved collection; Title: Medicare Program: Procedures for 
Making National Coverage Decisions; Use: The Centers for Medicare & 
Medicaid Services (CMS) revised the April 27, 1999 (64 FR 22619) notice 
and published a new notice on September 26, 2003 (68 FR 55634) that 
described the process we use to make Medicare coverage decisions 
including decisions regarding whether new technology and services can 
be covered. We have made changes to our internal procedures in response 
to the comments we received following publication of the 1999 notice 
and experience under our new process. Over the past several years, we 
received numerous suggestions to further revise our process to continue 
to make it more open, responsive, and understandable to the public. We 
share the goal of increasing public participation in the development of 
Medicare coverage issues. This will assist us in obtaining the 
information we require to make a national coverage determination in a 
timely manner and ensuring that the Medicare program continues to meet 
the needs of its beneficiaries. Form Number: CMS-R-290 (OCN: 0938-
0776); Frequency: Annual; Affected Public: Private Sector: Business or 
other for-profits; Number of Respondents: 200; Total Annual Responses: 
200; Total Annual Hours: 8,000. (For policy questions regarding this 
collection contact Katherine Tillman at 410-786-9252. 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 https://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.
    In commenting on the proposed information collections please 
reference the document identifier or OMB control number. To be assured 
consideration, comments and recommendations must be submitted in one of 
the following ways by October 9, 2012:
    1. Electronically. You may submit your comments electronically to 
https://www.regulations.gov. Follow the instructions for ``Comment or 
Submission'' or ``More Search Options'' to find the information 
collection document(s) 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.

    Dated: August 7, 2012.
Martique Jones,
Director, Regulations Development Group, Division B Office of Strategic 
Operations and Regulatory Affairs.
[FR Doc. 2012-19694 Filed 8-9-12; 8:45 am]
BILLING CODE 4120-01-P

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