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