[Federal Register Volume 83, Number 48 (Monday, March 12, 2018)]
[Notices]
[Pages 10730-10732]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-04893]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10394, CMS-10544, CMS-10008, CMS-855I, and 
CMS-10545]


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 required 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 the necessity and utility of the 
proposed information collection for the proper performance of the 
agency's functions, the accuracy of the estimated burden, ways to 
enhance the quality, utility, and clarity of the information to be 
collected, and the use of automated collection techniques or other 
forms of information technology to minimize the information collection 
burden.

DATES: Comments must be received by May 11, 2018.

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:

[[Page 10731]]

    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 
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' website 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: William Parham at (410) 786-4669.

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-10394 Application To Be Qualified Entity To Receive Medicare Data 
for Performance Measurement
CMS-10544 Good Cause Processes
CMS-10008 Eligibility of Drugs, Biologicals, and Radiopharmaceutical 
Agents for Transitional Pass-Through Status Under the Hospital
CMS-855i Medicare Enrollment Application for Physician and Non-
Physician Practitioners
CMS-10545 Outcome and Assessment Information Set (OASIS) OASIS-C2/ICD-
10

    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.

Information Collection

    1. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Application to be 
Qualified Entity to Receive Medicare Data for Performance Measurement; 
Use: The Patient Protection and Affordable Care Act (ACA) was enacted 
on March 23, 2010 (Pub. L. 111-148). ACA amends section 1874 of the 
Social Security Act by adding a new subsection (e) to make standardized 
extracts of Medicare claims data under Parts A, B, and D available to 
qualified entities to evaluate the performance of providers of services 
and suppliers. This is the application needed to determine an 
organization's eligibility as a qualified entity. To implement the 
requirements outlined in the legislation, CMS established the Qualified 
Entity Certification Program (QECP) to evaluate an organization's 
eligibility across three areas: Organizational and governance 
capabilities, addition of claims data from other sources (as required 
in the statute), and data privacy and security. This collection covers 
the application through which organizations provide information to CMS 
to determine whether they will be approved as a qualified entity. Form 
Number: CMS-10394 (OMB control number: 0938-1144); Frequency: 
Reporting--Yearly; Affected Public: Private Sector (State, Local, or 
Tribal Governments, Business or other for-profits, Not-for-Profit 
Institutions); Number of Respondents: 30; Total Annual Responses: 10; 
Total Annual Hours: 5,000. (For policy questions regarding this 
collection contact Kari Gaare at 410-786-8612.)
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Good Cause 
Processes; Use: Section 1851(g)(3)(B)(i) of the Act provides that MA 
organizations may terminate the enrollment of individuals who fail to 
pay basic and supplemental premiums after a grace period established by 
the plan. Section 1860D-1(b)(1)(B)(v) of the Act generally directs us 
to establish rules related to enrollment, dis-enrollment, and 
termination for Part D plan sponsors that are similar to those 
established for MA organizations under section 1851 of the Act. 
Consistent with these sections of the Act, subpart B in each of the 
Parts C and D regulations sets forth requirements with respect to 
involuntary dis-enrollment procedures at 42 CFR 422.74 and 423.44, 
respectively. In addition, section 1876(c)(3)(B) establishes that 
individuals may be dis-enrolled from coverage as specified in 
regulations. Thus, current regulations at 42 CFR 417.460 specify that a 
cost plan, specifically a Health Maintenance Organization (HMO) or 
competitive medical plan (CMP), may dis-enroll a member who fails to 
pay premiums or other charges imposed by the plan for deductible and 
coinsurance amounts. Within these regulatory provisions, individuals 
dis-enrolled for nonpayment of premiums are afforded a grace period in 
which to request reinstatement. As part of the reinstatement request 
process, they must demonstrate good cause for failure to pay within the 
initial grace period that led to their involuntary dis-enrollment and 
pay all overdue premiums within three calendar months after the dis-
enrollment date. Form Number: CMS-10544 (OMB control number: 0938-
1271); Frequency: Reporting--Monthly; Affected Public: Private Sector 
(Business or other for-profit institutions); Number of Respondents: 
10,008; Total Annual Responses: 10,008; Total Annual Hours: 6,665. (For 
policy questions regarding this collection contact Carla Patterson at 
410-786-1000).
    3. Type of Information Collection Request: Reinstatement with a 
change of a previously approved collection; Title of Information 
Collection: Eligibility of Drugs, Biologicals, and Radiopharmaceutical 
Agents for Transitional Pass-Through Status under the Hospital; Use: 
Section 1833(t)(6) of the Act provides for temporary additional 
payments or ``transitional pass-through payments'' for certain drugs 
and biological agents. As originally enacted by the Balanced Budget 
Refinement Act (BBRA), this provision required the Secretary to make 
additional payments to hospitals for current orphan drugs, as 
designated under section 526 of the Federal Food, Drug, and Cosmetic 
Act (Pub. L. 107-186); current drugs and biological agents and 
brachytherapy used for the treatment of cancer; and current 
radiopharmaceutical drugs and biological products. For those drugs and 
biological agents referred to as

[[Page 10732]]

``current,'' the transitional pass-through payment began on the first 
date the hospital OPPS was implemented (before enactment of Benefits 
Improvement and Protections Act (BIPA) (Pub. L. 106-554), on December 
21, 2000). Transitional pass-through payments are also required for 
certain ``new'' drugs, devices and biological agents that were not 
being paid for as a hospital outpatient department (OPD) service as of 
December 31, 1996, and whose cost is ``not insignificant'' in relation 
to the outpatient perspective payment system (OPPS) payment for the 
procedures or services associated with the new drug, device, or 
biological. Under the statute, transitional pass-through payments can 
be made for at least 2 years but not more than 3 years. We have 
qualified thousands for transitional pass-through payments through our 
application process. However, to keep pace with emerging new 
technologies and make them accessible to Medicare beneficiaries in a 
timely manner as the law intended, it is necessary that we continue to 
collect appropriate information from interested parties such as 
hospitals and pharmaceutical companies that bring to our attention 
specific new drugs, biologicals and radiopharmaceuticals to be 
evaluated for transitional pass-through status. Form Number: CMS-10008 
(OMB control number: 0938-0802); Frequency: Yearly; Affected Public: 
Private sector (Business or other for-profit institutions); Number of 
Respondents: 30; Total Annual Responses: 30; Total Annual Hours: 480. 
(For policy questions regarding this collection contact Raymond Bulls 
at 410-786-7267).
    4. Type of Information Collection Request: New collection (Request 
for new OMB control number); Title of Information Collection: Medicare 
Enrollment Application for Physician and Non-Physician Practitioners; 
Use: The application is used by Medicare contractors to collect data to 
ensure that the applicant has the necessary credentials to provide the 
health care services for which they intend to bill Medicare, including 
information that allows the Medicare contractor to correctly price, 
process and pay the applicant's claims. This application collects 
information to ensure that only legitimate physicians, non-physician 
practitioners, and other eligible professionals are enrolled in the 
Medicare program. It is meant to be the first line defense to protect 
our beneficiaries from illegitimate providers and to protect the 
Medicare Trust Fund against fraud. It also gathers information that 
allows Medicare contractors to ensure that the provider/supplier is not 
sanctioned from the Medicare and/or Medicaid program(s), or debarred, 
suspended or excluded from any other Federal agency or program. Form 
Number: CMS-855I (OMB control number: 0938--NEW); Frequency: On 
Occasion; Affected Public: State, Local, or Tribal Governments, Private 
Sector (not-for-profit institutions); Number of Respondents: 513,872; 
Total Annual Responses: 1,370,078; Total Annual Hours: 1,000,167. (For 
policy questions regarding this collection contact Kimberly McPhillips 
at 410-786-5374).
    5. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Outcome and 
Assessment Information Set (OASIS) OASIS-C2/ICD-10; Use: This request 
is for OMB approval to modify the Outcome and Assessment Information 
Set (OASIS) that home health agencies (HHAs) are required to collect in 
order to participate in the Medicare program. The current version of 
the OASIS, OASIS-C2 (0938-1279) data item set was approved by the 
Office of Management and Budget (OMB) on December 9, 2016 and 
implemented on January 1, 2017. We are seeking OMB approval for the 
proposed revised OASIS item set, referred to hereafter as OASIS-D, 
scheduled for implementation on January 1, 2019. The OASIS D is being 
modified to: Include changes pursuant to the Improving Medicare Post-
Acute Care Transformation Act of 2014 (the IMPACT Act); accommodate 
data element removals to reduce burden; and improve formatting 
throughout the document. Form Number: CMS-10545 (OMB control number: 
0938-1279); Frequency: Occasionally; Affected Public: Private Sector 
(Business or other for-profit and Not-for-profit institutions); Number 
of Respondents: 12,149; Total Annual Responses: 18,161,942; Total 
Annual Hours: 9,943,141. (For policy questions regarding this 
collection contact Joan Proctor at 410-786-0949.)

    Dated: March 7, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2018-04893 Filed 3-9-18; 8:45 am]
 BILLING CODE 4120-01-P