[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
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``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