81_FR_8531 81 FR 8498 - Agency Information Collection Activities: Proposed Collection; Comment Request

81 FR 8498 - Agency Information Collection Activities: Proposed Collection; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 81, Issue 33 (February 19, 2016)

Page Range8498-8500
FR Document2016-03474

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 require; 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 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.

Federal Register, Volume 81 Issue 33 (Friday, February 19, 2016)
[Federal Register Volume 81, Number 33 (Friday, February 19, 2016)]
[Notices]
[Pages 8498-8500]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-03474]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-484; CMS-846-849, 854, 10125 and 10126; CMS-
10379; and CMS-10418]


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 require; 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 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 must be received by April 19, 2016.

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

[[Page 8499]]

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' 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 [email protected].
    3. Call the Reports Clearance Office at (410) 786-1326.

FOR FURTHER INFORMATION CONTACT: Reports Clearance Office at (410) 786-
1326.

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-484 Attending Physician's Certification of Medical Necessity for 
Home Oxygen Therapy and Supporting Regulations
CMS-846-849, 854, 10125 and 10126 Durable Medical Equipment Medicare 
Administrative Contractors (MAC) Regional Carrier, Certificate of 
Medical Necessity and Supporting Documentation
CMS-10379 Rate Increase Disclosure and Review Reporting Requirements
CMS-10418 Medical Loss Ratio Annual Reports, MLR Notices, and 
Recordkeeping Requirements

    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.
    1. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Attending 
Physician's Certification of Medical Necessity for Home Oxygen Therapy 
and Supporting Regulations; 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 (OMB Control Number: 0938-0534); 
Frequency: Occasionally; Affected Public: Private Sector: Business or 
other for-profits, Not-for-profits; Number of Respondents: 8,880; Total 
Annual Responses: 1,632,000; Total Annual Hours: 326,500. (For policy 
questions regarding this collection contact Paula Smith at 410-786-
4709.)
    2. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Durable Medical 
Equipment Medicare Administrative Contractors (MAC) Regional Carrier, 
Certificate of Medical Necessity and Supporting Documentation; Use: The 
certificates of medical necessity (CMNs) collect information required 
to help determine the medical necessity of certain items. CMS requires 
CMNs where there may be a vulnerability to the Medicare program. Each 
initial claim for these items must have an associated CMN for the 
beneficiary. Suppliers (those who bill for the items) complete the 
administrative information (e.g., patient's name and address, items 
ordered, etc.) on each CMN. The 1994 Amendments to the Social Security 
Act require that the supplier also provide a narrative description of 
the items ordered and all related accessories, their charge for each of 
these items, and the Medicare fee schedule allowance (where 
applicable). The supplier then sends the CMN to the treating physician 
or other clinicians (e.g., physician assistant, LPN, etc.) who 
completes questions pertaining to the beneficiary's medical condition 
and signs the CMN. The physician or other clinician returns the CMN to 
the supplier who has the option to maintain a copy and then submits the 
CMN (paper or electronic) to CMS, along with a claim for reimbursement. 
This clearance request is for CMNs with the form numbers, CMS CMS-846-
849, 854, 10125 and 10126. Form Number: CMS-846-849, 854, 10125 and 
10126

[[Page 8500]]

(OMB Control Number: 0938-0679); Frequency: Occasionally; Affected 
Public: Individuals or Households; Number of Respondents: 462,000; 
Total Annual Responses: 462,000; Total Annual Hours: 418,563. (For 
policy questions regarding this collection contact Paula Smith at 410-
786-4709.)
    3. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Rate Increase 
Disclosure and Review Reporting Requirements; Use: Section 1003 of the 
Affordable Care Act adds a new section 2794 of the PHS Act which 
directs the Secretary of the Department of Health and Human Services 
(the Secretary), in conjunction with the states, to establish a process 
for the annual review of ``unreasonable increases in premiums for 
health insurance coverage.'' The statute provides that health insurance 
issuers must submit to the Secretary and the applicable state 
justifications for unreasonable premium increases prior to the 
implementation of the increases. Section 2794 also specifies that 
beginning with plan years beginning in 2014, the Secretary, in 
conjunction with the states, shall monitor premium increases of health 
insurance coverage offered through an Exchange and outside of an 
Exchange.
    Section 2794 directs the Secretary to ensure the public disclosure 
of information and justification relating to unreasonable rate 
increases. Section 2794 requires that health insurance issuers submit 
justification for an unreasonable rate increase to CMS and the relevant 
state prior to its implementation. Additionally, section 2794 requires 
that rate increases effective in 2014 (submitted for review in 2013) be 
monitored by the Secretary, in conjunction with the states. To those 
ends, Section 154 of the CFR establishes various reporting requirements 
for health insurance issuers, including a Preliminary Justification for 
a proposed rate increase, a Final Justification for any rate increase 
determined by a state or CMS to be unreasonable, and a notification 
requirement for unreasonable rate increases which the issuer will not 
implement.
    In order to obtain the information necessary to monitor premium 
increases of health insurance coverage offered through an Exchange and 
outside of an Exchange, 45 CFR 154.215 would require health insurance 
issuers to submit the Unified Rate Review Template for all single risk 
pool coverage products in the individual or small group (or merged) 
market, regardless of whether any plan within a product is subject to a 
rate increase. That regulation would also require health insurance 
issuers to submit an Actuarial Memorandum (in addition to the Unified 
Rate Review Template) when a plan within a product is subject to a rate 
increase. Although the two required documents are submitted at the risk 
pool level, the requirement to submit is based on increases at the plan 
level.
    In order to conduct a review to assess reasonableness when a plan 
within a product has a rate increase that is subject to review, health 
insurance issuers would be required to submit a written description 
justifying the increase (in addition to the Unified Rate Review 
Template and Actuarial Memorandum). Although the required documents are 
submitted at the risk pool level, the requirement to submit is based on 
increases at the plan level. Form Number: CMS-10379 (OMB Control 
Number: 0938-1141); Frequency: Yearly; Affected Public: State and 
Private sector (Business or other for-profits and Not-for-profit 
institutions); Number of Respondents: 1,081; Total Annual Responses: 
1,621; Total Annual Hours: 17,837. (For policy questions regarding this 
collection contact Lisa Cuozzo at 410-786-1746.)
    4. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Medical Loss 
Ratio Annual Reports, MLR Notices, and Recordkeeping Requirements; Use: 
Under Section 2718 of the Affordable Care Act and implementing 
regulation at 45 CFR part 158, a health insurance issuer (issuer) 
offering group or individual health insurance coverage must submit a 
report to the Secretary concerning the amount the issuer spends each 
year on claims, quality improvement expenses, non-claims costs, Federal 
and State taxes and licensing and regulatory fees, the amount of earned 
premium, and beginning with the 2014 reporting year, the amounts 
related to the transitional reinsurance, risk adjustment, and risk 
corridors. An issuer must provide an annual rebate if the amount it 
spends on certain costs compared to its premium revenue (excluding 
Federal and States taxes and licensing and regulatory fees) does not 
meet a certain ratio, referred to as the medical loss ratio (MLR). Each 
issuer is required to submit annually MLR data, including information 
about any rebates it must provide, on a form prescribed by CMS, for 
each State in which the issuer conducts business. Each issuer is also 
required to provide a rebate notice to each policyholder that is owed a 
rebate and each subscriber of policyholders that are owed a rebate for 
any given MLR reporting year. Additionally, each issuer is required to 
maintain for a period of seven years all documents, records and other 
evidence that support the data included in each issuer's annual report 
to the Secretary. Under Section 1342 of the Patient Protection and 
Affordable Care Act and implementing regulation at 45 CFR part 153, 
issuers of qualified health plans (QHPs) must participate in a risk 
corridors program. A QHP issuer is required to pay charges to or 
receive payments from CMS based on the ratio of the issuer's allowable 
costs to the target amount. Each QHP issuer is required to submit an 
annual report to CMS concerning the issuer's allowable costs, allowable 
administrative costs, and the amount of premium.
    The 2015 MLR Reporting Form and Instructions reflect changes for 
the 2015 reporting/benefit year and beyond. In 2016, it is expected 
that issuers will submit fewer reports and send fewer notices to 
policyholders and subscribers, which will reduce burden on issuers. On 
the other hand, it is expected that issuers will send more rebate 
checks in the mail to individual market policyholders, which will 
increase burden for some issuers. It is estimated that there will be a 
net reduction in total burden from 271,600 to 235,148. Form Number: 
CMS-10418 (OMB Control Number: 0938-1164); Frequency: Annually; 
Affected Public: Private Sector, Business or other for-profits and not-
for-profit institutions; Number of Respondents: 538; Number of 
Responses: 2,818; Total Annual Hours: 235,148. (For policy questions 
regarding this collection contact Christina Whitefield at 301-492-
4172.)

    Dated: February 16, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2016-03474 Filed 2-18-16; 8:45 am]
BILLING CODE 4120-01-P



                                                    8498                          Federal Register / Vol. 81, No. 33 / Friday, February 19, 2016 / Notices

                                                    explain or clarify status as a                          rescission notice, and patient protection             DEPARTMENT OF HEALTH AND
                                                    grandfathered health plan. The plan                     disclosure requirements that are subject              HUMAN SERVICES
                                                    must make such records available for                    to the Paperwork Reduction Act of 1995.
                                                    examination upon request by                             The enrollment opportunity notice was                 Centers for Medicare & Medicaid
                                                    participants, beneficiaries, individual                 to be used by health plans to notify                  Services
                                                    policy subscribers, or a State or Federal               certain individuals of their right to re-             [Document Identifier: CMS–484; CMS–846–
                                                    agency official. A grandfathered health                 enroll in their plan. This notice was a               849, 854, 10125 and 10126; CMS–10379; and
                                                    plan is also required to include a                      one-time requirement and has been                     CMS–10418]
                                                    statement in any summary of benefits                    discontinued. The rescission notice will
                                                    under the plan or health insurance                      be used by health plans to provide                    Agency Information Collection
                                                    coverage, that the plan or coverage                     advance notice to certain individuals                 Activities: Proposed Collection;
                                                    believes it is a grandfathered health plan              that their coverage may be rescinded as               Comment Request
                                                    within the meaning of section 1251 of
                                                                                                            a result of fraud or intentional                      AGENCY: Centers for Medicare &
                                                    the Affordable Care Act, and providing
                                                                                                            misrepresentation of material fact. The               Medicaid Services, HHS.
                                                    contact information for participants to
                                                    direct questions and complaints. In                     patient protection notification will be               ACTION: Notice.
                                                    addition, a grandfathered group health                  used by health plans to inform certain
                                                    plan that is changing health insurance                  individuals of their right to choose a                SUMMARY:   The Centers for Medicare &
                                                    issuers is required to provide the                      primary care provider or pediatrician                 Medicaid Services (CMS) is announcing
                                                    succeeding health insurance issuer (and                 and to use obstetrical/gynecological                  an opportunity for the public to
                                                    the succeeding health insurance issuer                  services without prior authorization.                 comment on CMS’ intention to collect
                                                    must require) documentation of plan                                                                           information from the public. Under the
                                                                                                               The related provisions are finalized in
                                                    terms (including benefits, cost sharing,                                                                      Paperwork Reduction Act of 1995 (the
                                                                                                            the final regulations titled ‘‘Final Rules
                                                    employer contributions, and annual                                                                            PRA), federal agencies are require; to
                                                                                                            Under the Affordable Care Act for                     publish notice in the Federal Register
                                                    limits) under the prior health insurance                Grandfathered Plans, Preexisting
                                                    coverage sufficient to make a                                                                                 concerning each proposed collection of
                                                                                                            Condition Exclusions, Lifetime and                    information (including each proposed
                                                    determination whether the standards of                  Annual Limits, Rescissions, Dependent
                                                    paragraph (g)(1) of the interim final                                                                         extension or reinstatement of an existing
                                                                                                            Coverage, Appeals, and Patient                        collection of information) and to allow
                                                    regulations are exceeded. It is also                    Protections’’. The final regulations also
                                                    required that, for an insured group                                                                           60 days for public comment on the
                                                                                                            require that, if State law prohibits                  proposed action. Interested persons are
                                                    health plan (or a multiemployer plan)                   balance billing, or a plan or issuer is
                                                    that is a grandfathered plan, the relevant                                                                    invited to send comments regarding our
                                                                                                            contractually responsible for any                     burden estimates or any other aspect of
                                                    policies, certificates, or contracts of
                                                                                                            amounts balanced billed by an out-of-                 this collection of information, including
                                                    insurance, or plan documents must
                                                    disclose in a prominent and effective                   network emergency services provider, a                any of the following subjects: (1) The
                                                    manner that employers, employee                         plan or issuer must provide a                         necessity and utility of the proposed
                                                    organizations, or plan sponsors, as                     participant, beneficiary or enrollee                  information collection for the proper
                                                    applicable, are required to notify the                  adequate and prominent notice of their                performance of the agency’s functions;
                                                    issuer (or multiemployer plan) if the                   lack of financial responsibility with                 (2) the accuracy of the estimated
                                                    contribution rate changes at any point                  respect to amounts balanced billed in                 burden; (3) ways to enhance the quality,
                                                    during the plan year. Form Number:                      order to prevent inadvertent payment by               utility, and clarity of the information to
                                                    CMS–10325 (OMB Control Number:                          the individual. Form Number: CMS–                     be collected; and (4) the use of
                                                    0938–1093); Frequency: Occasionally;                    10330 (OMB Control Number: 0938–                      automated collection techniques or
                                                    Affected Public: State, Local, or Tribal                1094); Frequency: Occasionally;                       other forms of information technology to
                                                    Governments, Private Sector; Number of                  Affected Public: Private Sector, State,               minimize the information collection
                                                    Respondents: 55,378; Total Annual                       Local, or Tribal Governments; Number                  burden.
                                                    Responses: 6,858,135; Total Annual                      of Respondents: 3,171; Total Annual                   DATES:  Comments must be received by
                                                    Hours: 248. (For policy questions                       Responses: 238,244; Total Annual                      April 19, 2016.
                                                    regarding this collection contact Russell               Hours: 897. (For policy questions                     ADDRESSES: When commenting, please
                                                    Tipps at (301) 492–4371).                               regarding this collection contact Russell             reference the document identifier or
                                                       2. Type of Information Collection                    Tipps at 301–492–4371).                               OMB control number. To be assured
                                                    Request: Revision of a currently                           Dated: February 16, 2016.                          consideration, comments and
                                                    approved collection; Title of                                                                                 recommendations must be submitted in
                                                                                                            William N. Parham, III,
                                                    Information Collection: Enrollment                                                                            any one of the following ways:
                                                    Opportunity Notice Relating to Lifetime                 Director, Paperwork Reduction Staff, Office             1. Electronically. You may send your
                                                    Limits; Required Notice of Rescission of                of Strategic Operations and Regulatory                comments electronically to http://
                                                    Coverage; and Disclosure Requirements                   Affairs.                                              www.regulations.gov. Follow the
                                                    for Patient Protection Under the                        [FR Doc. 2016–03473 Filed 2–18–16; 8:45 am]           instructions for ‘‘Comment or
                                                    Affordable Care Act; Use: Sections 2711,                BILLING CODE 4120–01–P                                Submission’’ or ‘‘More Search Options’’
                                                    2712 and 2719A of the Public Health                                                                           to find the information collection
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                    Service Act, as added by the Affordable                                                                       document(s) that are accepting
                                                    Care Act, and the interim final                                                                               comments.
                                                    regulations titled ‘‘Patient Protection                                                                         2. By regular mail. You may mail
                                                    and Affordable Care Act: Preexisting                                                                          written comments to the following
                                                    Condition Exclusions, Lifetime and                                                                            address: CMS, Office of Strategic
                                                    Annual Limits, Rescissions, and Patient                                                                       Operations and Regulatory Affairs,
                                                    Protections’’ (75 FR 37188, June 28,                                                                          Division of Regulations Development,
                                                    2010) contain enrollment opportunity,                                                                         Attention: Document Identifier/OMB


                                               VerDate Sep<11>2014   17:59 Feb 18, 2016   Jkt 238001   PO 00000   Frm 00025   Fmt 4703   Sfmt 4703   E:\FR\FM\19FEN1.SGM   19FEN1


                                                                                  Federal Register / Vol. 81, No. 33 / Friday, February 19, 2016 / Notices                                           8499

                                                    Control Number ll, Room C4–26–05,                          1. Type of Information Collection                  therapy are found in Medicare Carriers
                                                    7500 Security Boulevard, Baltimore,                     Request: Extension of a currently                     Manual Chapter II—Coverage Issues
                                                    Maryland 21244–1850.                                    approved collection; Title of                         Appendix, Section 60–4. For Medicare
                                                      To obtain copies of a supporting                      Information Collection: Attending                     to consider any item for coverage and
                                                    statement and any related forms for the                 Physician’s Certification of Medical                  payment, the information submitted by
                                                    proposed collection(s) summarized in                    Necessity for Home Oxygen Therapy                     the supplier (e.g., claims and CMNs),
                                                    this notice, you may make your request                  and Supporting Regulations; Use: Under                including documentation in the
                                                    using one of following:                                 Section 1862(a)(1)(A) of the Social                   patient’s medical records must
                                                      1. Access CMS’ Web site address at                    Security Act (the Act), 42 U.S.C.                     corroborate that the patient meets
                                                    http://www.cms.hhs.gov/                                 1395y(a), the Secretary may only pay for              Medicare coverage criteria. The patient’s
                                                    PaperworkReductionActof1995.                            items and services that are ‘‘reasonable              medical records may include:
                                                      2. Email your request, including your                 and necessary for the diagnosis or                    Physician’s office records; hospital
                                                    address, phone number, OMB number,                      treatment of illness or injury or to                  records; nursing home records; home
                                                    and CMS document identifier, to                         improve the functioning of a malformed                health agency records; records from
                                                    Paperwork@cms.hhs.gov.                                  body member.’’ In order to assure this,               other healthcare professionals or test
                                                      3. Call the Reports Clearance Office at               CMS and its contractors develop                       reports. This documentation must be
                                                    (410) 786–1326.                                         Medical policies that specify the                     available to the DME MACs upon
                                                    FOR FURTHER INFORMATION CONTACT:                        circumstances under which an item or                  request. Form Number: CMS–484 (OMB
                                                    Reports Clearance Office at (410) 786–                  service can be covered. The certificate of            Control Number: 0938–0534);
                                                    1326.                                                   medical necessity (CMN) provides a                    Frequency: Occasionally; Affected
                                                                                                            mechanism for suppliers of Durable                    Public: Private Sector: Business or other
                                                    SUPPLEMENTARY INFORMATION:                                                                                    for-profits, Not-for-profits; Number of
                                                                                                            Medical Equipment, defined in 42
                                                    Contents                                                U.S.C. 1395x (n), and Medical                         Respondents: 8,880; Total Annual
                                                                                                            Equipment and Supplies defined in 42                  Responses: 1,632,000; Total Annual
                                                      This notice sets out a summary of the                                                                       Hours: 326,500. (For policy questions
                                                                                                            U.S.C. 1395j(5), to demonstrate that the
                                                    use and burden associated with the                                                                            regarding this collection contact Paula
                                                                                                            item being provided meets the criteria
                                                    following information collections. More                                                                       Smith at 410–786–4709.)
                                                                                                            for Medicare coverage. Section 1833(e),
                                                    detailed information can be found in
                                                                                                            42 U.S.C. 1395l(e), provides that no                     2. Type of Information Collection
                                                    each collection’s supporting statement
                                                                                                            payment can be made to any provider of                Request: Revision of a currently
                                                    and associated materials (see
                                                                                                            services, or other person, unless that                approved collection; Title of
                                                    ADDRESSES).
                                                                                                            person has furnished the information                  Information Collection: Durable Medical
                                                    CMS–484 Attending Physician’s                           necessary for Medicare or its contractor              Equipment Medicare Administrative
                                                      Certification of Medical Necessity for                to determine the amounts due to be                    Contractors (MAC) Regional Carrier,
                                                      Home Oxygen Therapy and                               paid. Certain individuals can use a CMN               Certificate of Medical Necessity and
                                                      Supporting Regulations                                to furnish this information, rather than              Supporting Documentation; Use: The
                                                    CMS–846–849, 854, 10125 and 10126                       having to produce large quantities of                 certificates of medical necessity (CMNs)
                                                      Durable Medical Equipment Medicare                    medical records for every claim they                  collect information required to help
                                                      Administrative Contractors (MAC)                      submit for payment. Under Section                     determine the medical necessity of
                                                      Regional Carrier, Certificate of                      1834(j)(2) of the Act, 42 U.S.C.                      certain items. CMS requires CMNs
                                                      Medical Necessity and Supporting                      1395m(j)(2), suppliers of DME items are               where there may be a vulnerability to
                                                      Documentation                                         prohibited from providing medical                     the Medicare program. Each initial
                                                    CMS–10379 Rate Increase Disclosure                      information to physicians when a CMN                  claim for these items must have an
                                                      and Review Reporting Requirements                     is being completed to document medical                associated CMN for the beneficiary.
                                                    CMS–10418 Medical Loss Ratio Annual                     necessity. The physician who orders the               Suppliers (those who bill for the items)
                                                      Reports, MLR Notices, and                             item is responsible for providing the                 complete the administrative information
                                                      Recordkeeping Requirements                            information necessary to demonstrate                  (e.g., patient’s name and address, items
                                                      Under the PRA (44 U.S.C. 3501–                        that the item provided is reasonable and              ordered, etc.) on each CMN. The 1994
                                                    3520), federal agencies must obtain                     necessary and the supplier shall also list            Amendments to the Social Security Act
                                                    approval from the Office of Management                  on the CMN the fee schedule amount                    require that the supplier also provide a
                                                    and Budget (OMB) for each collection of                 and the suppliers charge for the medical              narrative description of the items
                                                    information they conduct or sponsor.                    equipment or supplies being furnished                 ordered and all related accessories, their
                                                    The term ‘‘collection of information’’ is               prior to distribution of such certificate             charge for each of these items, and the
                                                    defined in 44 U.S.C. 3502(3) and 5 CFR                  to the physician. Any supplier of                     Medicare fee schedule allowance (where
                                                    1320.3(c) and includes agency requests                  medical equipment who knowingly and                   applicable). The supplier then sends the
                                                    or requirements that members of the                     willfully distributes a CMN in violation              CMN to the treating physician or other
                                                    public submit reports, keep records, or                 of this restriction is subject to penalties,          clinicians (e.g., physician assistant,
                                                    provide information to a third party.                   including civil money penalties (42                   LPN, etc.) who completes questions
                                                    Section 3506(c)(2)(A) of the PRA                        U.S.C. 1395m (j)(2)(A)(iii)). Under                   pertaining to the beneficiary’s medical
                                                    requires federal agencies to publish a                  Section 42 Code of Federal Regulations                condition and signs the CMN. The
                                                    60-day notice in the Federal Register                   § 410.38 and § 424.5, Medicare has the                physician or other clinician returns the
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                                                    concerning each proposed collection of                  legal authority to collect sufficient                 CMN to the supplier who has the option
                                                    information, including each proposed                    information to determine payment for                  to maintain a copy and then submits the
                                                    extension or reinstatement of an existing               oxygen, and oxygen equipment. Oxygen                  CMN (paper or electronic) to CMS,
                                                    collection of information, before                       and oxygen equipment is by far the                    along with a claim for reimbursement.
                                                    submitting the collection to OMB for                    largest single total charge of all items              This clearance request is for CMNs with
                                                    approval. To comply with this                           paid under durable medical equipment                  the form numbers, CMS CMS–846–849,
                                                    requirement, CMS is publishing this                     coverage authority. Detailed criteria                 854, 10125 and 10126. Form Number:
                                                    notice.                                                 concerning coverage of home oxygen                    CMS–846–849, 854, 10125 and 10126


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                                                    8500                          Federal Register / Vol. 81, No. 33 / Friday, February 19, 2016 / Notices

                                                    (OMB Control Number: 0938–0679);                        That regulation would also require                    any given MLR reporting year.
                                                    Frequency: Occasionally; Affected                       health insurance issuers to submit an                 Additionally, each issuer is required to
                                                    Public: Individuals or Households;                      Actuarial Memorandum (in addition to                  maintain for a period of seven years all
                                                    Number of Respondents: 462,000; Total                   the Unified Rate Review Template)                     documents, records and other evidence
                                                    Annual Responses: 462,000; Total                        when a plan within a product is subject               that support the data included in each
                                                    Annual Hours: 418,563. (For policy                      to a rate increase. Although the two                  issuer’s annual report to the Secretary.
                                                    questions regarding this collection                     required documents are submitted at the               Under Section 1342 of the Patient
                                                    contact Paula Smith at 410–786–4709.)                   risk pool level, the requirement to                   Protection and Affordable Care Act and
                                                       3. Type of Information Collection                    submit is based on increases at the plan              implementing regulation at 45 CFR part
                                                    Request: Revision of a currently                        level.                                                153, issuers of qualified health plans
                                                    approved collection; Title of                              In order to conduct a review to assess             (QHPs) must participate in a risk
                                                    Information Collection: Rate Increase                   reasonableness when a plan within a                   corridors program. A QHP issuer is
                                                    Disclosure and Review Reporting                         product has a rate increase that is                   required to pay charges to or receive
                                                    Requirements; Use: Section 1003 of the                  subject to review, health insurance                   payments from CMS based on the ratio
                                                    Affordable Care Act adds a new section                  issuers would be required to submit a                 of the issuer’s allowable costs to the
                                                    2794 of the PHS Act which directs the                   written description justifying the                    target amount. Each QHP issuer is
                                                    Secretary of the Department of Health                   increase (in addition to the Unified Rate             required to submit an annual report to
                                                    and Human Services (the Secretary), in                  Review Template and Actuarial                         CMS concerning the issuer’s allowable
                                                    conjunction with the states, to establish               Memorandum). Although the required                    costs, allowable administrative costs,
                                                    a process for the annual review of                      documents are submitted at the risk                   and the amount of premium.
                                                    ‘‘unreasonable increases in premiums                    pool level, the requirement to submit is                 The 2015 MLR Reporting Form and
                                                    for health insurance coverage.’’ The                    based on increases at the plan level.                 Instructions reflect changes for the 2015
                                                    statute provides that health insurance                  Form Number: CMS–10379 (OMB                           reporting/benefit year and beyond. In
                                                    issuers must submit to the Secretary and                Control Number: 0938–1141);                           2016, it is expected that issuers will
                                                    the applicable state justifications for                 Frequency: Yearly; Affected Public:                   submit fewer reports and send fewer
                                                    unreasonable premium increases prior                    State and Private sector (Business or                 notices to policyholders and
                                                    to the implementation of the increases.                 other for-profits and Not-for-profit                  subscribers, which will reduce burden
                                                    Section 2794 also specifies that                        institutions); Number of Respondents:                 on issuers. On the other hand, it is
                                                    beginning with plan years beginning in                  1,081; Total Annual Responses: 1,621;                 expected that issuers will send more
                                                    2014, the Secretary, in conjunction with                Total Annual Hours: 17,837. (For policy               rebate checks in the mail to individual
                                                    the states, shall monitor premium                       questions regarding this collection                   market policyholders, which will
                                                    increases of health insurance coverage                  contact Lisa Cuozzo at 410–786–1746.)                 increase burden for some issuers. It is
                                                    offered through an Exchange and                            4. Type of Information Collection                  estimated that there will be a net
                                                    outside of an Exchange.                                 Request: Extension of a currently                     reduction in total burden from 271,600
                                                       Section 2794 directs the Secretary to                approved collection; Title of                         to 235,148. Form Number: CMS–10418
                                                    ensure the public disclosure of                         Information Collection: Medical Loss                  (OMB Control Number: 0938–1164);
                                                    information and justification relating to               Ratio Annual Reports, MLR Notices, and                Frequency: Annually; Affected Public:
                                                    unreasonable rate increases. Section                    Recordkeeping Requirements; Use:                      Private Sector, Business or other for-
                                                    2794 requires that health insurance                     Under Section 2718 of the Affordable                  profits and not-for-profit institutions;
                                                    issuers submit justification for an                     Care Act and implementing regulation                  Number of Respondents: 538; Number
                                                    unreasonable rate increase to CMS and                   at 45 CFR part 158, a health insurance
                                                                                                                                                                  of Responses: 2,818; Total Annual
                                                    the relevant state prior to its                         issuer (issuer) offering group or
                                                                                                                                                                  Hours: 235,148. (For policy questions
                                                    implementation. Additionally, section                   individual health insurance coverage
                                                                                                                                                                  regarding this collection contact
                                                    2794 requires that rate increases                       must submit a report to the Secretary
                                                                                                                                                                  Christina Whitefield at 301–492–4172.)
                                                    effective in 2014 (submitted for review                 concerning the amount the issuer
                                                    in 2013) be monitored by the Secretary,                 spends each year on claims, quality                      Dated: February 16, 2016.
                                                    in conjunction with the states. To those                improvement expenses, non-claims                      William N. Parham, III,
                                                    ends, Section 154 of the CFR establishes                costs, Federal and State taxes and                    Director, Paperwork Reduction Staff, Office
                                                    various reporting requirements for                      licensing and regulatory fees, the                    of Strategic Operations and Regulatory
                                                    health insurance issuers, including a                   amount of earned premium, and                         Affairs.
                                                    Preliminary Justification for a proposed                beginning with the 2014 reporting year,               [FR Doc. 2016–03474 Filed 2–18–16; 8:45 am]
                                                    rate increase, a Final Justification for                the amounts related to the transitional               BILLING CODE 4120–01–P
                                                    any rate increase determined by a state                 reinsurance, risk adjustment, and risk
                                                    or CMS to be unreasonable, and a                        corridors. An issuer must provide an
                                                    notification requirement for                            annual rebate if the amount it spends on              DEPARTMENT OF HEALTH AND
                                                    unreasonable rate increases which the                   certain costs compared to its premium                 HUMAN SERVICES
                                                    issuer will not implement.                              revenue (excluding Federal and States
                                                       In order to obtain the information                   taxes and licensing and regulatory fees)              Administration for Children and
                                                    necessary to monitor premium increases                  does not meet a certain ratio, referred to            Families
                                                    of health insurance coverage offered                    as the medical loss ratio (MLR). Each
                                                    through an Exchange and outside of an                   issuer is required to submit annually                 Submission for OMB Review;
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                                                    Exchange, 45 CFR 154.215 would                          MLR data, including information about                 Comment Request
                                                    require health insurance issuers to                     any rebates it must provide, on a form                  Title: Native Employment Works
                                                    submit the Unified Rate Review                          prescribed by CMS, for each State in                  (NEW) Program Plan Guidance and
                                                    Template for all single risk pool                       which the issuer conducts business.                   Native Employment Works (NEW)
                                                    coverage products in the individual or                  Each issuer is also required to provide               Program Report.
                                                    small group (or merged) market,                         a rebate notice to each policyholder that               OMB No.: 0970–0174.
                                                    regardless of whether any plan within a                 is owed a rebate and each subscriber of                 Description: The Native Employment
                                                    product is subject to a rate increase.                  policyholders that are owed a rebate for              Works (NEW) program plan is the


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Document Created: 2018-02-02 14:31:50
Document Modified: 2018-02-02 14:31:50
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesComments must be received by April 19, 2016.
ContactReports Clearance Office at (410) 786- 1326.
FR Citation81 FR 8498 

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