[Federal Register Volume 81, Number 33 (Friday, February 19, 2016)]
[Notices]
[Pages 8498-8500]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

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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