Roster-of-Pending-Regulations-2015-04-01b

advertisement
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
Lead Agency: SHORT TITLE
Reference Number; Title of Reg/Agency
Action
Tribal Consultation Policy
Treasury (no reference number)
Tribal Consultation Policy
Agency release
date; due date
Agency’s Summary of Action
for comments
Released:
This notice announces an interim policy outlining the guiding principles for all
12/3/2014
Department of Treasury (Treasury) bureaus and offices engaging with tribal
Governments on matters with tribal implications. Treasury will update the
Due date:
policy periodically and refine it as needed to reflect ongoing engagement and
4/2/2015
collaboration with tribal partners.
http://www.gpo.gov/fdsys/pkg/FR-2014-1203/pdf/2014-28383.pdf
Notes:
12/3/2014: Coordinate
response with NCAI.
1/21/2015: Elliott to check
in with NCAI. IRS may be
invited to Feb MMPC
meeting.
2/4/2015: Richard to
discuss Treasury – IRS
relationship with Christie
Jacobs with regard to the
consultation policy and will
circulate existing Treasury /
IRS consultation policy, if
any.
3/12/2015: Elliott to draft
one page comment (in
conjunction with NCAI
efforts)
4/1/2015: Draft comment is
embedded below.
Draft NIHB
Comments on Tribal Treasury Consultation Pol
Survey Report Form for CLIA
CMS-1557
Released:
3/6/2015
1. Type of Information Collection Request: Extension of a currently approved
collection; Title: Survey Report Form for Clinical Laboratory Improvement
3/6/2015: Paperwork
Amendments (CLIA) and Supporting Regulations; Use: Surveyors use the form
Reduction Act notice. No
PRA Request for Comment
Due date:
to report their findings during a CLIA survey. For each type of survey
comments recommended.
4/6/2015
conducted (i.e., initial certification, recertification, validation, complaint,
http://www.gpo.gov/fdsys/pkg/FR-2015-03addition/deletion of specialty/subspecialty, transfusion fatality investigation,
06/pdf/2015-05165.pdf
or revisit inspections) the form incorporates the requirements specified in the
CLIA regulations.
Roster key: Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 1 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
Transcatheter Mitral Valve Repair National
Coverage Decision
CMS-10531
PRA Request for Comment
Released:
3/6/2015
Due date:
4/6/2015
http://www.gpo.gov/fdsys/pkg/FR-2015-0306/pdf/2015-05165.pdf
2. Type of Information Collection Request: New collection; Title: Transcatheter
Mitral Valve Repair (TMVR) National Coverage Decision (NCD); Use: The CMS
National Coverage Determination (NCD) titled, “Transcatheter Mitral Valve
Repair (TMVR),” requires this data collection. Medicare covers the TMVR
device only when specific conditions are met, including that the heart team
and hospital submit data in a prospective, national, audited registry. The data
includes patient-, practitioner-, and facility-level variables that predict
outcomes such as all-cause mortality and quality of life.
3/6/2015: Paperwork
Reduction Act notice. No
comments recommended.
The Society of Thoracic Surgery/American College of Cardiology
Transcatheter Valve Therapy (STS/ACC TVT) Registry, one registry overseen
by the National Cardiovascular Data Registry, meets the requirements
specified in the NCD on TMVR. The TVT Registry will support a national
surveillance system to monitor the safety and efficacy of the TMVR
technologies for the treatment of mitral regurgitation (MR). The data also will
include the variables on the eight item Kansas City Cardiomyopathy
Questionnaire (KCCQ-10) to assess heath status, functioning, and quality of
life. The KCCQ allows the derivation of an overall summary score from the
physical function, symptoms (frequency and severity), social function, and
quality of life domains.
Employer Notification of Objection to
Covering Contraceptive Services
CMS-10535
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2015-0306/pdf/2015-05165.pdf
Roster key:
Released:
3/6/2015
Due date:
4/6/2015
The data collected and analyzed in the TVT Registry will help determine if
TMVR is reasonable and necessary (e.g., improves health outcomes) for
Medicare beneficiaries under Section 1862(a)(1)(A) of the Social Security Act.
Furthermore, data from the Registry will assist the medical device industry
and the FDA in surveillance of the quality, safety, and efficacy of new medical
devices to treat mitral regurgitation. For purposes of the TMVR NCD, the TVT
Registry has contracted with the Data Analytic Centers to conduct the
analyses. In addition, CMS will make data available for research purposes
under the terms of a data use agreement that only provides de-identified
datasets.
3. Type of Information Collection Request: Revision of a currently approved
collection; Title: Employer Notification to HHS of its Objection to Providing
Coverage for Contraceptive Services; Use: The proposed rules titled
“Coverage of Certain Preventive Services Under the Affordable Care Act” (79
FR 51118) would continue to require each closely-held, for-profit corporation
seeking treatment as an eligible organization to provide notification that it
will not act as the plan administrator or claims administrator with respect to,
or contribute to the funding of, coverage of all or a subset of contraceptive
3/6/2015: Paperwork
Reduction Act notice. No
comments recommended.
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 2 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
services. Issuers and third party administrators providing payments for
contraceptive services for participants and beneficiaries in plans of eligible
organizations would have to meet the notice requirements as set forth in the
2013 final regulations.
Medicaid Eligibility Changes Under ACA
CMS-10410
Released:
2/6/2015
PRA Request for Comment
Due date:
4/7/2015
http://www.gpo.gov/fdsys/pkg/FR-2015-0206/pdf/2015-02414.pdf
Income and Eligibility Verification System
Reporting
CMS-R-74
PRA Request for Comment
Released:
2/6/2015
Due date:
4/7/2015
http://www.gpo.gov/fdsys/pkg/FR-2015-0206/pdf/2015-02414.pdf
Hospital and Hospital Health Care Complex
Cost Report
CMS-2552-10
Released:
2/6/2015
Due date:
Roster key:
The interim final regulations titled “Coverage of Certain Preventive Services
Under the Affordable Care Act” (79 FR 51092) continue to allow eligible
organizations that have religious objections to providing contraceptive
coverage to notify an issuer or third party administrator using EBSA Form 700,
as set forth in the July 2013 final regulations. In addition, the interim final
regulations permit an alternative process under which an eligible organization
could notify the HHS Secretary that it will not act as the plan administrator or
claims administrator with respect to, or contribute to the funding of,
coverage of all or a subset of contraceptive services.
1. Type of Information Collection Request: Extension of a currently approved
collection; Title: Medicaid Program; Eligibility Changes Under the Affordable
Care Act of 2010; Use: The eligibility systems are essential to the goal of
increasing coverage in insurance affordability programs while reducing
administrative burden on states and consumers. The electronic transmission
and automation of data transfers serve as key elements in managing the
expected insurance affordability program caseload that started in 2014.
2. Type of Information Collection Request: Extension of a currently approved
collection; Title: Income and Eligibility Verification System Reporting and
Supporting Regulations; Use: A state Medicaid agency that currently obtains
and uses information from certain sources, or with more frequency than
specified, could continue to do so to the extent that the verifications prove
useful and not redundant. An agency that has found it effective to verify all
wage or benefit information with another agency or with the recipient can
continue these practices if it chooses. In addition, the agency can implement
an approved targeting plan under 42 CFR 435.953. Agency experience should
guide its decision whether to exceed these regulatory requirements on
income and eligibility verification. While states can target resources when
verifying income of course, agencies remain accountable for their accuracy in
eligibility determinations.
3. Type of Information Collection Request: Revision of a currently approved
collection; Title: Hospital and Hospital Health Care Complex Cost Report; Use:
Providers of services participating in the Medicare program must, under
sections 1815(a) and 1861(v)(1)(A) of the Social Security Act (42 U.S.C. 1395g),
2/6/2015: Extension of a
currently approved
Paperwork Reduction Act
notice.
No comments
recommended.
2/6/2015: Extension of a
currently approved
Paperwork Reduction Act
notice.
No comments
recommended.
2/6/2015: Paperwork
Reduction Act notice.
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 3 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
PRA Request for Comment
4/7/2015
http://www.gpo.gov/fdsys/pkg/FR-2015-0206/pdf/2015-02414.pdf
submit annual information to achieve settlement of costs for health care
services rendered to Medicare beneficiaries. In addition, regulations at 42 CFR
413.20 and 413.24 require adequate cost data and cost reports from
providers on an annual basis.
CMS seeks OMB review and approval of this revision to form CMS-2552-10,
Hospital and Hospital Health Care Complex Cost Report. Hospitals
participating in the Medicare program file these cost reports annually to
determine the reasonable costs incurred to provide medical services to
patients. The revisions made to the hospital cost report comport with the
statutory requirement for hospice payment reform in § 3132 of ACA and the
statutory requirement establishing a prospective payment system for
Federally Qualified Health Centers in § 10501(i)(3)(A) of ACA.
Medicare Enrollment Application:
Reassignment of Benefits
CMS-855R
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2015-0206/pdf/2015-02414.pdf
Released:
2/6/2015
Due date:
4/7/2015
4. Type of Information Collection Request: Revision of a currently approved
collection; Title: Medicare Enrollment Application: Reassignment of Medicare
Benefits ; Use: The CMS-855R enrollment application allows physicians and
non-physician practitioners to reassign their Medicare benefits to a group
practice and to gather information from the individual that tells CMS who
he/she is, where he/she renders services, and information necessary to
establish correct claims payment. CMS periodically evaluates and revises the
CMS-855R enrollment application to simplify and clarify the information
collection without jeopardizing its need to collect specific information.
The proposed changes
incorporate changes related
to hospice care and a PPS
system for FQHCs. This PRA
notice may be of interest to
some Indian health care
providers.
2/6/2015: Paperwork
Reduction Act notice. Minor
changes to an already
approved collection.
No comments
recommended.
CMS has made very few minor revisions to the CMS-855R (Reassignment of
Benefits) Medicare enrollment application (OMB 0938-1179). CMS has
revised two sections within the form to maintain sync with online and paper
forms. The previously approved CMS-855R section 2 collected information
regarding the individual practitioner reassigning benefits and section 3
collected information regarding the organization/group receiving the
reassigned benefits. CMS has reversed these two sections but has not revised
information or data collection within these sections. With the exception of
this section reversal and adding the word “optional” to sections 4 and 5
(primary practice location and contact person information), CMS has made no
other revisions. These revisions offer no new data collection in this revision
package. The addition of the optional choice in sections 4 and 5 could
potentially reduce the burden to providers who choose not to complete
either or both optional sections.
Roster key:
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 4 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
Rural Health Care Services Outreach
Program Measures
HRSA (OMB 0906-xxxx)
PRA Request for Comment
Released:
3/9/2015
Due date:
4/8/2015
http://www.gpo.gov/fdsys/pkg/FR-2015-0309/pdf/2015-05414.pdf
Type of Information Collection Request: New collection; Title: Rural Health
Care Services Outreach Program Measures; Use: The Rural Health Care
Services Outreach (Outreach) Program--authorized by Section 330A(e) of the
Public Health Service Act (PHS Act), as amended--seeks to “promote rural
health care services outreach by expanding the delivery of health care
services to include new and enhanced services in rural areas.” The goals for
the Outreach Program include the following: (1) Expand the delivery of health
care services to include new and enhanced services exclusively in rural
communities; (2) deliver health care services through a strong consortium in
which every consortium member organization actively participates and
engages in the planning and delivery of services; (3) utilize and/or adapt an
evidence-based or promising practice model(s) in the delivery of health care
services; and (4) improve population health and demonstrate health
outcomes and sustainability.
3/10/2015: Paperwork
Reduction Act notice.
No comments
recommended.
For this program, HRSA draft performance measures to provide data to the
program and to enable the agency to provide aggregate program data
required by Congress under the Government Performance and Results Act
(GPRA) of 1993. These measures cover the principal topic areas of interest to
the HRSA Office of Rural Health Policy, including: (a) Access to care; (b)
population demographics; (c) staffing; (d) consortium/network; (e)
sustainability; and (f) project specific domains. HRSA will use several
measures for the Outreach Program. All measures will speak to ORHP
progress toward meeting the goals set.
HRSA received no comments in response to the 60-day notice published in
the December 22, 2014, Federal Register (79 FR 76334).
Distributions from an HSA, Archer MSA or
Medical Advantage MSA
Form 1099-SA
PRA Request for Comment
Released:
2/10/2015
Due date:
4/13/2015
Type of Information Collection Request: Extension of a currently approved
collection; Title: Distributions from an HSA, Archer MSA, or Medical
Advantage MSA; Use: Individuals use this form to report distributions from a
medical savings account as required by Internal Revenue Code section 220(h).
IRS has made no changes to this form.
Released:
2/11/2015
Type of Information Collection Request: Extension of a currently approved
collection; Title: Initial Plan Data Collection to Support Qualified Health Plan
2/10/2015: Paperwork
Reduction Act notice.
No comments
recommended.
http://www.gpo.gov/fdsys/pkg/FR-2015-0210/pdf/2015-02639.pdf
Data Collection to Support QHP Certification
and Other Exchange Operations
Roster key:
2/11/2015: Paperwork
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 5 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
CMS-10433
PRA Request for Comment
Due date:
4/13/2015
http://www.gpo.gov/fdsys/pkg/FR-2015-0211/pdf/2015-02852.pdf
Rural Health Network Development
Program
HRSA (OMB 0906-xxxx)
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2015-0313/pdf/2015-05733.pdf
Released:
3/13/2015
Due date:
4/13/2015
(QHP) Certification and Other Financial Management and Exchange
Operations; Use: As required by CMS-9989-F, Patient Protection and
Affordable Care Act; Establishment of Exchanges and Qualified Health Plans;
Exchange Standards for Employers (77 FR 18310) (Exchange Establishment
Rule), each Exchange must assume responsibilities related to the certification
and offering of Qualified Health Plans (QHPs). In addition to data collection
for the certification of QHPs, the reinsurance and risk adjustment programs
outlined by tACA, detailed in 45 CFR part 153, as established by CMS-9975-F,
Patient Protection and Affordable Care Act; Standards for Reinsurance, Risk
Corridors, and Risk Adjustment (77 FR 17220), have general information
reporting requirements that apply to issuers, group health plans, third party
administrators, and plan offerings outside of the Exchanges. Subsequent
regulations for these programs including the final HHS Notice of Benefit and
Payment Parameters for 2014 and the Program Integrity: Exchange, Premium
Stabilization Programs, and Market Standards; Amendments to the HHS
Notice of Benefit and Payment Parameters for 2014, and the final HHS Notice
of Benefit and Payment Parameters for 2015 provide further reporting
requirements.
Type of Information Collection Request: New collection; Title: Rural Health
Network Development Program; Use: Under the Rural Health Network
Development Program--authorized under Section 330A(f) of the Public Health
Service Act (PHS Act), as amended--the HRSA Office of Rural Health Policy
(ORHP) supports grants for eligible entities to promote, through planning and
implementation, the development of integrated health care networks that
have combined the functions of the entities participating in the networks to:
(i) Achieve efficiencies; (ii) expand access to, coordinate, and improve the
quality of essential health care services; and (iii) strengthen the rural health
care system as a whole.
Reduction Act notice
extending a previously
approved collection.
There may be issues
pertaining to gathering data
from QHPs on contract
offerings to Indian health
care providers, but such
comments are likely better
directed to the underlying
regulations rather than the
associated PRA notice.
As such, no comments
recommended.
3/13/2015: Paperwork
Reduction Act notice.
No comments
recommended.
For this program, HRSA drafted performance measures to provide data to the
program and to enable the agency to provide aggregate program data. These
measures cover the principal topic areas of interest to ORHP, including: (a)
Network infrastructure; (b) network collaboration; (c) sustainability; and (d)
network assessment. HRSA will use several measures for this program.
HRSA received no comments in response to the 60-day notice published in
the December 22, 2014, Federal Register (79 FR 76334).
Roster key:
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 6 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
Medical Expenditure Panel Survey-Insurance Component
AHRQ (OMB 0935-0110)
PRA Request for Comment
Released:
2/18/2015
Due date:
4/20/2015
http://www.gpo.gov/fdsys/pkg/FR-2015-0218/pdf/2015-02905.pdf
Type of Information Collection Request: Revision of a currently approved
collection; Title: Medical Expenditure Panel Survey--Insurance Component;
Use: Employer-sponsored health insurance serves as the source of coverage
for 78 million current and former workers, plus many of their family
members. The Medical Expenditure Panel Survey--Insurance Component
(MEPS-IC) measures on an annual basis the extent, cost, and coverage of
employer-sponsored health insurance. AHRQ produces these statistics at the
National, State, and sub-State (metropolitan area) level for private industry,
as well as for State and Local governments. All of the supporting documents
for the current MEPS-IC are available on the OMB Web site at
http://www.reginfo.gov/public/do/PRAViewDocument?ref_nbr=2013100935-001.
2/20/2015: Paperwork
Reduction Act notice.
No comments
recommended.
To ensure that the MEPS-IC can capture important changes in the employersponsored health insurance market due to the implementation of ACA,
AHRQ will field a longitudinal survey in 2015 to include a sample of 5,000
small private sector employers that responded to the 2014 MEPS-IC. The
OMB clearance approved on November 21, 2013, included the 2014
longitudinal survey, a survey of 3,000 respondents to the 2013 MEPS-IC, but
did not include the 2015 longitudinal survey because AHRQ had not
finalized the sample size. This information collection request includes no
other changes.
Receipt of Non-VA Care and Selection of
Provider for Veterans Choice Program
VA (OMB 2900-0823)
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2015-0219/pdf/2015-03354.pdf
Roster key:
Released:
2/19/2015
Due date:
4/20/2015
1. Type of Information Collection Request: Extension of a currently approved
collection; Title: Election to Receive Authorized Non-VA Care and Selection of
Provider for the Veterans Choice Program; Use: Section 17.1515 requires
eligible veterans to notify VA whether the veteran elects to receive
authorized non-VA care through the Veterans Choice Program, get placed
on an electronic waiting list, or get scheduled for an appointment with a VA
health care provider. Section 17.1515(b)(1) also allows eligible veterans to
specify a particular non-VA entity or health care provider, if that entity or
provider meets certain requirements.
2/20/2015: Paperwork
Reduction Act notice.
Uncertain about
applicability to veterans
who are HIS beneficiaries.
It may be worthwhile to
review this document in
regard to decisions by IHS
beneficiaries who are
veterans to elect to receive
care at I/T/U facilities.
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 7 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
Health Care Plan Information for Veterans
Choice Program
VA (OMB 2900-0823)
PRA Request for Comment
Released:
2/19/2015
Due date:
4/20/2015
2. Type of Information Collection Request: Extension of a currently approved
collection; Title: Health Care Plan Information for the Veterans Choice
Program; Use: Section 17.1510(d) requires eligible veterans to submit to VA
information about their health care plan to participate in the Veterans
Choice Program.
http://www.gpo.gov/fdsys/pkg/FR-2015-0219/pdf/2015-03354.pdf
Submission of Medical Record Information
Under Veterans Choice Program
VA (OMB 2900-0823)
PRA Request for Comment
Released:
2/19/2015
Due date:
4/20/2015
3. Type of Information Collection Request: Extension of a currently approved
collection; Title: Submission of Medical Record Information under the
Veterans Choice Program; Use: Participating eligible entities and providers
must submit a copy of any medical record related to hospital care or medical
services furnished under the Veterans Choice Program to an eligible veteran.
http://www.gpo.gov/fdsys/pkg/FR-2015-0219/pdf/2015-03354.pdf
Submission of Information on Credentials
by Eligible Entities or Providers
VA (OMB 2900-0823)
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2015-0219/pdf/2015-03354.pdf
Roster key:
Released:
2/19/2015
Due date:
4/20/2015
4. Type of Information Collection Request: Extension of a currently approved
collection; Title: Submission of Information on Credentials and Licenses by
Eligible Entities or Providers; Use: Section 17.1530 requires eligible entities
and providers to submit verification that the entity or provider maintains at
least the same or similar credentials and licenses as those required of VA
health care providers, as determined by the VA Secretary.
2/20/2015: Paperwork
Reduction Act notice.
Uncertain about
applicability to veterans
who are IHS beneficiaries
(as compared to exiswting
MOAs in effect). It may be
worthwhile to review this
document in regard to
decisions by IHS
beneficiaries who are
veterans to elect to receive
care at I/T/U facilities.
2/20/2015: Paperwork
Reduction Act notice.
Uncertain about
applicability to veterans
who are IHS beneficiaries
(as compared to existing
MOAs in effect). It may be
worthwhile to review this
document in regard to
decisions by IHS
beneficiaries who are
veterans to elect to receive
care at I/T/U facilities.
2/20/2015: Paperwork
Reduction Act notice.
Uncertain about
applicability to veterans
who are IHS beneficiaries
(as compared to MOAs that
are currently in place). It
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 8 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
may be worthwhile to
review this document in
regard to decisions by IHS
beneficiaries who are
veterans to elect to receive
care at I/T/U facilities.
Rural Access to Emergency Devices Grant
Program
HRSA (OMB 0915-xxxx)
PRA Request for Comment
Released:
2/20/2015
Due date:
4/21/2015
http://www.gpo.gov/fdsys/pkg/FR-2015-0220/pdf/2015-03525.pdf
Survey of Retail Prices
CMS-10241
Released:
3/25/2015
PRA Request for Comment
Due date:
4/24/2015
http://www.gpo.gov/fdsys/pkg/FR-2015-0325/pdf/2015-06884.pdf
Roster key:
Type of Information Collection Request: New collection; Title: Rural Access to
Emergency Devices Grant Program; Use: This program, authorized by the
Public Health Improvement Act title IV--Cardiac Arrest Survival Act of 2000,
subtitle B-Rural Access to Emergency Devices, section 413 and the
Consolidated and Further Continuing Appropriations Act, seeks to: (1)
Purchase automated external defibrillators (AEDs) approved, or cleared for
marketing, by FDA; (2) provide defibrillator and basic life support training in
automated external defibrillator usage through the American Heart
Association, the American Red Cross, or other nationally recognized training
courses; and (3) place the AEDs in rural communities with local organizations.
For this program, HRSA drafted performance measures to provide data useful
to the program and to enable the agency to provide aggregate program data
required by Congress under the Government Performance and Results Act
(GPRA) of 1993. These measures cover the principal topic areas of interest to
the HRSA Office of Rural Health Policy, including: (a) The number of counties
served by the program; (b) the number of AEDs purchased and placed and
the locations of the placements; (c) the number of training sessions and the
number of individuals trained; (d) the number of times an AED is used and
the outcome; and (e) the number of lay persons and first responders who
administer CPR or use an AED on an individual.
1. Type of Information Collection Request: Revision of a currently approved
collection; Title: Survey of Retail Prices: Payment and Utilization Rates and
Performance Rankings; Use: Survey of Retail Prices: Payment and Utilization
Rates, and Performance Rankings; Use: This study has two parts. Part I
focuses on the retail community pharmacy consumer prices. It also includes
reporting by the states of payment and utilization rates for the 50 most
widely prescribed drugs and comparing state drug payment rates with the
national retail survey prices. Part II focuses on the retail community
pharmacy ingredient costs. This segment surveys the average acquisition
costs of all covered outpatient drugs purchased by retail community
pharmacies, with prices updated on at least a monthly basis. Subsequent to
the publication of the 60-day notice in the December 19, 2014, Federal
2/20/2015: Paperwork
Reduction Act notice.
No comments
recommended.
3/26/2015: Paperwork
Reduction Act notice.
No comments
recommended.
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 9 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
Administrative Requirements for DRA
Section 6071
CMS-10249
PRA Request for Comment
Released:
3/25/2015
Due date:
4/24/2015
http://www.gpo.gov/fdsys/pkg/FR-2015-0325/pdf/2015-06884.pdf
Outcome and Assessment Information Set-OASIS-C1/ICD-10
CMS-10545
PRA Request for Comment
Released:
3/25/2015
Due date:
4/24/2015
http://www.gpo.gov/fdsys/pkg/FR-2015-0325/pdf/2015-06884.pdf
Appointment of Representative
CMS-1696
Released:
2/27/2015
PRA Request for Comment
Due date:
Roster key:
Register (79 FR 75816), CMS has reduced the burden by removing
requirements for Part I pending funding decisions. CMS has made no
changes to Part II.
2. Type of Information Collection Request: Extension of a currently approved
collection; Title: Administrative Requirements for Section 6071 of the Deficit
Reduction Act; Use: State Operational Protocols should provide enough
information such that: The CMS Project Officer and other federal officials can
use it to understand the operation of the demonstration and/or prepare for
potential site visits without needing additional information; the State Project
Director can use it as the manual for program implementation; and external
stakeholders can use it to understand the operation of the demonstration.
CMS uses the financial information collection in its financial statements and
shares it with the auditors who validate the financial position of the agency.
The national evaluation contractor uses the Money Follows the Person
Rebalancing Demonstration (MFP) Finders File, MFP Program Participation
Data File, and MFP Services File to assess program outcomes, while CMS uses
the information to monitor program implementation. The national evaluation
contractor uses MFP Quality of Life data to assess program outcomes. The
evaluation determines how participant quality of life changes after
transitioning to the community. The national evaluation contractor and CMS
use the semi-annual progress report to monitor program implementation at
the grantee level.
3. Type of Information Collection Request: New collection; Title: Outcome and
Assessment Information Set (OASIS) OASIS-C1/ICD-10; Use: Home health
agencies (HHAs) must collect the outcome and assessment information data
set (OASIS) to participate in the Medicare program. CMS requests a new OMB
control number for the proposed revised OASIS item set, referred to
hereafter as OASIS-C1/ICD-10. OMB on October 7, 2014, approved the
current version of the OASIS-C1/ICD-9 data set (OMB 0938-0760), which will
remain in use until the implementation of the ICD-10 coding system, currently
scheduled for October 1, 2015. Subsequent to the publication of the 60-day
notice in the January 9, 2015, Federal Register (80 FR 1419), CMS has made
a minor typographical correction to the data set.
1. Type of Information Collection Request: Extension of a currently approved
collection; Title: Appointment of Representative; Use: Beneficiaries, providers
and suppliers, and any party seeking to appoint a representative to assist
them with their initial determinations and filing appeals complete the
3/26/2015: Paperwork
Reduction Act notice.
No comments
recommended.
3/26/2015: Paperwork
Reduction Act notice.
No comments
recommended.
2/27/2015: Paperwork
Reduction Act notice of
existing collection without
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 10 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
http://www.gpo.gov/fdsys/pkg/FR-2015-0227/pdf/2015-04115.pdf
Medicare Fee-for-Service Prepayment
Medical Review
CMS-10417
PRA Request for Comment
4/28/2015
Appointment of Representative form. This extension request proposes nonsubstantive changes to the form.
Released:
2/27/2015
2. Type of Information Collection Request: Extension of a currently approved
collection; Title: Medicare Fee-for-Service Prepayment Medical Review; Use:
Medicare contractors request the information required under this collection
to determine proper payment or suspicion of fraud. Medicare contractors
request the information from providers or suppliers submitting claims for
payment from the Medicare program when data analysis indicates aberrant
billing patterns or other information that might present a vulnerability to the
Medicare program.
Due date:
4/28/2015
http://www.gpo.gov/fdsys/pkg/FR-2015-0227/pdf/2015-04115.pdf
Collection of Qualitative Feedback on
Agency Service Delivery
IHS-2015-0002
PRA Request for Comment
Released:
2/27/2015
Due date:
4/28/2015
http://www.gpo.gov/fdsys/pkg/FR-2015-0302/pdf/2015-04112.pdf
Verification of Clinic Data--Rural Health
Clinic Form
CMS-29
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2015-0330/pdf/2015-07219.pdf
Roster key:
Released:
3/30/2015
Due date:
4/29/2015
Type of Information Collection Request: Extension of a currently approved
collection; Title: Generic Clearance for the Collection of Qualitative Feedback
on Agency Service Delivery: IHS Customer Service Satisfaction and Similar
Surveys; Use: The proposed information collection activity provides a means
to garner qualitative customer and stakeholder feedback in an efficient,
timely manner, in accordance with the commitment of the Administration to
improving service delivery. Qualitative feedback provides useful insights on
perceptions and opinions but, unlike statistical surveys that yield quantitative
results, is not generalizable to the population of study. This feedback will
provide insights into customer or stakeholder perceptions, experiences, and
expectations; provide an early warning of issues with service; or focus
attention on areas where communication, training, or changes in operations
might improve delivery of products or services. These collections will allow
for ongoing, collaborative, and actionable communications between IHS and
its customers and stakeholders. It also will allow feedback to contribute
directly to the improvement of program management.
1.
Type of Information Collection Request: Extension of a currently
approved collection; Title: Verification of Clinic Data--Rural Health
Clinic Form and Supporting Regulations; Use: This form serves as an
application completed by suppliers of Rural Health Clinic (RHC)
services requesting participation in the Medicare program. This form
initiates the process of obtaining a decision as to whether applicants
meet the conditions for certification as a supplier of RHC services. It
also promotes data reduction or introduction to and retrieval from
the Automated Survey Process Environment (ASPEN) and related
survey and certification databases by the CMS Regional Offices.
change. No comments
recommended.
2/27/2015: Paperwork
Reduction Act notice of
existing collection without
change. No comments
recommended.
3/3/2015: Paperwork
Reduction Act notice of
existing collection without
change. No comments
recommended.
3/30/2015: Paperwork
Reduction Act notice of
existing collection without
change. No comments
recommended.
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 11 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
Site Investigation for Independent
Diagnostic Testing Facilities
CMS-10221
PRA Request for Comment
Released:
3/30/2015
Due date:
4/29/2015
http://www.gpo.gov/fdsys/pkg/FR-2015-0330/pdf/2015-07219.pdf
Site Investigation for Suppliers of DMEPOS
CMS-R-263
Released:
3/30/2015
PRA Request for Comment
Due date:
4/29/2015
http://www.gpo.gov/fdsys/pkg/FR-2015-0330/pdf/2015-07219.pdf
New System of Records Notice (Restricted
Dataset Requesters)
HHS (no reference number)
Privacy Act of 1974; System of Records
Notice
Roster key:
Released:
4/1/2015
Due date: 30
days (approx.
5/1/2015)
2.
2. Type of Information Collection Request: Extension of a currently approved
collection; Title: Site Investigation for Independent Diagnostic Testing
Facilities (IDTFs); Use: CMS enrolls Independent Diagnostic Testing Facilities
(IDTFs) into the Medicare program via a uniform application, CMS-855B.
Implementation of enhanced procedures for verifying the enrollment
information has improved the enrollment process, as well as identified and
prevented fraudulent IDTFs from entering the Medicare program. This
process requires verification of compliance with IDTF performance standards.
The site investigation form for IDTFs provides a standardized, uniform tool to
gather information from an IDTF to inform CMS whether it meets certain
standards required of an IDTF (as found in 42 CFR 410.33(g)) and where it
practices or renders its services. The site investigation form also has aided in
verifying compliance with the required performance standards found in 42
CFR 410.33(g). CMS has made no revisions to this form since the last
submission for OMB approval.
3. Type of Information Collection Request: Extension of a currently approved
collection; Title: Site Investigation for Suppliers of Durable Medical
Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Use: CMS enrolls
suppliers of durable medical equipment, prosthetics, orthotics, and supplies
(DMEPOS) into the Medicare program via a uniform application, CMS-855S.
Implementation of enhanced procedures for verifying the enrollment
information has improved the enrollment process, as well as identified and
prevented fraudulent DMEPOS suppliers from entering the Medicare
program. This process requires verification of compliance with supplier
standards. The site investigation form provides a standardized, uniform tool
to gather information from a DMEPOS supplier to inform CMS whether it
meets certain qualifications required of a DMEPOS supplier (as found in 42
CFR 424.57(c)) and where it practices or renders its services. The site
investigation form also has aided in verifying compliance with the required
supplier standards found in 42 CFR 424.57(c). CMS has made no revisions to
this form since the last submission for OMB approval.
In accordance with the requirements of the Privacy Act of 1974, as amended,
HHS has established a new department-wide system of records, “Records
about Restricted Dataset Requesters,” System Number 09-90-1401, to cover
records about individuals within and outside HHS who request restricted
datasets and software products from HHS (e.g., for health-related scientific
research and study purposes), when HHS maintains the requester records in a
system from which an individual requester retrieves them directly (by name
3/30/2015: Paperwork
Reduction Act notice of
existing collection without
change. No comments
recommended.
3/30/2015: Paperwork
Reduction Act notice of
existing collection without
change. No comments
recommended.
4/1/2015: Paperwork
Reduction Act notice.
No comments
recommended.
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 12 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
http://www.gpo.gov/fdsys/pkg/FR-2015-0401/pdf/2015-07444.pdf
State Annual Long-Term Care Ombudsman
Report and Instructions
HHS (OMB 0985-0005)
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2015-0304/pdf/2015-04470.pdf
Released:
3/4/2015
Due date:
5/4/2015
or other personal identifier). HHS has deleted the System of Records Notice
(SORN) previously published at 78 FR 32654 for “Online Application Ordering
for Products from the Healthcare Cost and Utilization Project (HCUP),”
System Number 09-35-0003, and replaced it with this new department-wide
SORN.
Type of Information Collection Request: Extension of a currently approved
collection; Title: State Annual Long-Term Care Ombudsman Report and
Instructions; Use: States provide the following data and narrative information
in the report:
 Numbers and descriptions of cases filed and complaints made on
behalf of long-term care facility residents to the statewide
ombudsman program;
 Major issues identified impacting on the quality of care and life of
long-term care facility residents;
 Statewide program operations; and
 Ombudsman activities in addition to complaint investigation.
3/5/2015: Paperwork
Reduction Act notice.
No comments
recommended.
The data collected on complaints filed with Ombudsman programs and
narrative on long-term care issues provide information to CMS and others on
patterns of concerns and major long-term care issues affecting residents of
long-term care facilities. Both the complaint and program data collected
assist the states and local Ombudsman programs in planning strategies and
activities, providing training and technical assistance, and developing
performance measures. The report and instructions are available at
http://www.aoa.acl.gov/AoA_Programs/Elder_Rights/Ombudsman/NORS.asp
x.
Agent/Broker Data Collection in FederallyReleased:
Type of Information Collection Request: Extension of a currently approved
Facilitated Exchanges
3/6/2015
collection; Title: Agent/Broker Data Collection in Federally-Facilitated Health
3/6/2015: Paperwork
CMS-10464
Insurance Exchanges; Use: CMS collects personally identifiable information
Reduction Act notice.
Due date:
from agents/brokers to register them with the Federally-Facilitated
PRA Request for Comment
5/5/2015
Marketplace (FFM) and permit them to assist individuals and employers in
No comments
enrolling in the FFM. CMS uses this collection of information to ensure
recommended.
http://www.gpo.gov/fdsys/pkg/FR-2015-03agents/brokers possess the basic knowledge required to enroll individuals
06/pdf/2015-05166.pdf
and Small Business Health Options Program (SHOP) employers/employees
through the Marketplaces. Agents/brokers will use CMS or third-party
systems to enter identifying information and register with the FFM. As a
component of registration, agents/brokers must complete online training
courses through a CMS or third-party Learning Management System (LMS).
Upon completion of their applications and training requirements,
Roster key: Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 13 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
SHOP Effective Date and Termination
Notice Requirements
CMS-10555
PRA Request for Comment
Released:
3/9/2015
Due date:
5/8/2015
http://www.gpo.gov/fdsys/pkg/FR-2015-0309/pdf/2015-05420.pdf
National Implementation of the Hospital
CAHPS Survey
CMS-10102
PRA Request for Comment
Released:
3/13/2015
Due date:
5/12/2015
http://www.gpo.gov/fdsys/pkg/FR-2015-0313/pdf/2015-05796.pdf
Excise Tax on High Cost EmployerSponsored Health Coverage
Notice 2015-16
Section 4980I--Excise Tax on High Cost
Employer-Sponsored Health Coverage
http://www.irs.gov/pub/irs-drop/n-1516.pdf
Released:
2/23/2015
Due date:
5/15/2015
agents/brokers must attest to their agreement to adhere to FFM standards
and requirements through a CMS or third-party LMS.
Type of Information Collection Request: New collection; Title: Small Business
Health Options Program (SHOP) Effective Date and Termination Notice
Requirements; Use: CMS requires that, for plan years beginning on or after
January 1, 2017, the Small Business Health Options Program (SHOP) must
ensure that a qualified health plan (QHP) issuer notifies qualified employees,
enrollees, and new enrollees in a QHP through the SHOP of the effective date
of coverage. As required by the Patient Protection and Affordable Care Act;
HHS Notice of Benefit and Payment Parameter for 2016 (CMS-9944-F),
published on February 27, 2015, if any enrollee has his or her coverage
terminated through the SHOP due to non-payment of premiums or a loss of
eligibility to participate in the SHOP, the SHOP must notify the enrollee or the
qualified employer of the termination of such coverage. In the termination of
coverage, the SHOP must include the termination date and reason for
termination to the enrollee or qualified employer.
Type of Information Collection Request: Extension of a currently approved
collection; Title: National Implementation of the Hospital CAHPS Survey; Use:
Since 2006, the HCAHPS (Hospital Consumer Assessment of Healthcare
Providers and Systems) Survey--also known as the CAHPS Hospital Survey or
Hospital CAHPS, a standardized survey instrument and data collection
methodology--has measured patient perspectives of hospital care. While
many hospitals collect information on patient satisfaction, HCAHPS created a
national standard for collecting and public reporting information that enables
valid comparisons across all hospitals to support consumer choice.
This notice seeks to initiate and inform the process of developing regulatory
guidance regarding the excise tax on high cost employer-sponsored health
coverage under § 4980I of the Internal Revenue Code (Code). Section 4980I,
added to the Code by ACA, applies to taxable years beginning after December
31, 2017. Under this provision, if the aggregate cost of “applicable employersponsored coverage” (referred to in this notice as applicable coverage)
provided to an employee exceeds a statutory dollar limit, which is revised
annually, the excess is subject to a 40% excise tax.
This notice describes potential approaches with regard to a number of issues
under § 4980I, which IRS might incorporate in future proposed regulations,
and invites comments on these potential approaches. The issues addressed in
this notice primarily relate to (1) the definition of applicable coverage, (2) the
Roster key:
3/10/2015: Paperwork
Reduction Act notice.
No comments
recommended.
2/25/2015: There may be
Tribal-specific comments
warranted on the
application of the “Cadillac
tax”.
In order to determine what
comments might be
appropriate, it would be
useful to gain an
understanding of the extent
to which plans offered by
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 14 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
determination of the cost of applicable coverage, and (3) the application of
the annual statutory dollar limit to the cost of applicable coverage. The
Department of the Treasury (Treasury) and IRS invite comments on the issues
addressed in this notice and on any other issues under § 4980I.
Treasury and IRS anticipate issuing another notice, before the publication of
proposed regulations under § 4980I, describing and inviting comments on
potential approaches to a number of issues not addressed in this notice,
including procedural issues relating to the calculation and assessment of the
excise tax. After considering the comments on both notices, Treasury and IRS
anticipate publishing proposed regulations under § 4980I. The proposed
regulations will provide further opportunity for comment, including an
opportunity to comment on the issues addressed in the preceding notices.
2015-03-17
Summary of IRS Notice 2015-16.pdf
Proposed Project Behavioral Health
Information Technologies Survey
SAMHSA (no reference number)
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2015-0317/pdf/2015-06038.pdf
Released:
3/17/2015
Due date:
5/18/2015
Type of Information Collection Request: New collection; Title: Proposed
Project Behavioral Health Information Technologies Survey; Use: The
SAMHSA Center for Substance Abuse Treatment (CSAT) and Center for
Behavioral Health Statistics and Quality (CBHSQ) propose a survey to assess
health information technology (HIT) adoption among SAMHSA grantees. As
part of its Strategic Initiative to advance the use of HIT to support integrated
behavioral health care, SAMHSA has worked to develop a survey instrument
that will examine the status of and plans for HIT adoption by behavioral
health service providers implementing SAMHSA grant programs. This project
seeks to acquire baseline data necessary to inform the Strategic Initiative. The
survey of SAMHSA grantees regarding their access to and use of HIT will
provide valuable information that will inform the behavioral HIT literature.
tribal employers are
projected to be subject to
this tax.
3/12/2015: Sam to share an
analysis/summary of the
regulation. Efforts
underway to determine the
extent to which tribal
employers have insurance
coverage that may approach
the threshold levels to be
subject to the excise tax.
3/17/2015: A summary of
this notice is embedded to
the left.
3/17/2015: Paperwork
Reduction Act notice. No
comments recommended.
This data collection will allow SAMHSA to identify the current status of HIT
adoption and use among a diverse group of grantees. Data from the survey
will allow SAMHSA to enhance the HIT-related programmatic activities among
its grantees by providing data on how HIT facilitates the implementation of
different types of SAMHSA grants, thereby fostering the appropriate adoption
of HIT within SAMSHA-funded programs.
The survey will collect data once, providing a snapshot view of the current
state of HIT adoption. The proposed participant pool includes SAMHSA
Roster key:
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 15 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
Branded Prescription Drug Fee
REG-112805-10 (OMB 1545-2209)
Released:
3/17/2015
PRA Request for Comment
Due date:
5/18/2015
http://www.gpo.gov/fdsys/pkg/FR-2015-0317/pdf/2015-06073.pdf
Hospital National Provider Survey
CMS-10550
Released:
3/20/2015
PRA Request for Comment
Due date:
5/19/2015
http://www.gpo.gov/fdsys/pkg/FR-2015-0320/pdf/2015-06408.pdf
grantee program leadership who volunteer to provide the assistance needed
to ensure a high rate of response. Awardees from nine different SAMHSA
programs drawn from CMHS, CSAT, and CSAP comprise the pool of survey
participants. The survey will use a Web-based tool with embedded skip logic
for respondents to avoid questions not applicable to them.
Type of Information Collection Request: Extension of a currently approved
collection; Title: Branded Prescription Drug Fee; Use: Section 9008 of ACA
imposes an annual fee on manufacturers and importers of branded
prescription drugs that have gross receipts of over $5 million from the sales
of these drugs to certain government programs (covered entity/covered
entities). Section 51.7T(b) of IRS temporary regulations provide that the
agency will send each covered entity notification of its preliminary fee
calculation by May 15 of the fee year. If a covered entity chooses to dispute
the preliminary fee calculation, the covered entity must follow the
procedures for submitting an error report established in §51.8T. IRS will use
the data voluntarily supplied by a covered entity that disputes its preliminary
fee calculation to verify the accuracy of the data and the calculation used to
determine the fee.
1. Type of Information Collection Request: New collection; Title: Hospital
National Provider Survey; Use: Section 3104 of ACA requires that the
Secretary of HHS conduct an assessment of the quality and efficiency impact
of the use of endorsed measures in specific Medicare quality reporting and
incentive programs. ACA further specifies that the initial assessment must
occur no later than March 1, 2012, and once every 3 years thereafter. CMS
developed and tested this planned data collection as part of the 2015 Impact
Report and will conduct data collection for reporting in the 2018 Impact
Report.
3/17/2015: Paperwork
Reduction Act notice. No
comments recommended.
3/20/2015: Paperwork
Reduction Act notice. No
comments recommended.
This data collection, which involves hospital quality leaders, includes: (1) A
semi-structured qualitative interview and (2) a standardized survey. CMS will
analyze the data from the qualitative interviews and standardized surveys to
provide it with information on the quality and efficiency impact of measures
that it uses to assess care in the hospital inpatient and outpatient settings.
The surveys seek to understand whether the use of performance measures
has led to changes in provider behavior and where undesired effects have
occurred as a result of implementing quality and efficiency measures. The
survey also will help identify characteristics associated with high
performance, which, if understood, could assist in leveraging improvements
in care among lower performing hospitals. The survey seeks to assess the
Roster key:
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 16 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
Nursing Home National Provider Survey
CMS-10551
Released:
3/20/2015
PRA Request for Comment
Due date:
5/19/2015
http://www.gpo.gov/fdsys/pkg/FR-2015-0320/pdf/2015-06408.pdf
Health Insurance Providers Fee
REG-143416-14
Released:
2/26/2015
Health Insurance Providers Fee
Due date:
5/27/2015
http://www.gpo.gov/fdsys/pkg/FR-2015-0226/pdf/2015-03945.pdf
Medicare and Medicaid EHR Incentive
Program--Stage 3
CMS-3310-P
Released:
3/20/2015
Published:
Roster key:
impacts of the measures that CMS uses in the context of public reporting
(pay-for-reporting) and value-based purchasing programs.
2. Type of Information Collection Request: New collection; Title: Nursing
Home National Provider Survey; Use: Section 3104 of ACA requires that the
Secretary of HHS conduct an assessment of the quality and efficiency impact
of the use of endorsed measures in specific Medicare quality reporting and
incentive programs. ACA further specifies that the initial assessment must
occur no later than March 1, 2012, and once every 3 years thereafter. CMS
developed and tested this planned data collection as part of the 2015 Impact
Report and will conduct data collection for reporting in the 2018 Impact
Report.
This data collection, which involves nursing home quality leaders, includes:
(1) A semi-structured qualitative interview and (2) a standardized survey.
CMS will analyze the data from the qualitative interviews and standardized
surveys to provide it with information on the quality and efficiency impact of
measures that it uses to assess care in nursing homes delivering skilled
nursing care. The surveys seek to understand whether the use of
performance measures has led to changes in provider behavior (both at the
nursing home-level and at the frontline of care) and whether undesired
effects have occurred as a result of implementing quality and efficiency
measures. The survey also will help identify characteristics associated with
high performance, which, if understood, could assist in leveraging
improvements in care among lower performing nursing homes. The survey
seeks to assess the impacts of the measures that CMS uses in the context of
public reporting (pay-for-reporting) and quality improvement.
This document contains proposed regulations that provide rules for the
definition of a covered entity for purposes of the fee imposed by section 9010
of ACA. Elsewhere in this issue of the Federal Register, IRS has issued
temporary regulations (TD 9711). The text of those temporary regulations
also serves as the text of these proposed regulations. The proposed
regulations clarify certain terms in section 9010. The proposed regulations
affect individuals engaged in the business of providing health insurance for
U.S. health risks.
This Stage 3 proposed rule would specify the meaningful use criteria that
eligible professionals (EPs), eligible hospitals, and critical access hospitals
(CAHs) must meet to qualify for Medicare and Medicaid electronic health
record (EHR) incentive payments and avoid downward payment adjustments
3/20/2015: Paperwork
Reduction Act notice. No
comments recommended.
3/18/2015: Under review.
1/21/2015: NIHB technical
experts will be asked if they
have suggested comments.
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 17 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
Medicare and Medicaid Programs; Electronic
Health Record Incentive Program--Stage 3
http://www.gpo.gov/fdsys/pkg/FR-2015-0330/pdf/2015-06685.pdf
2015 Edition Health IT Certification Criteria,
et al.
HHS ONC (RIN 0991-AB93)
2015 Edition Health Information Technology
(Health IT) Certification Criteria, 2015
Edition Base Electronic Health Record (EHR)
Definition, and ONC Health IT Certification
Program Modifications
http://www.gpo.gov/fdsys/pkg/FR-2015-0330/pdf/2015-06612.pdf
Information Collection for Machine
Readable Data for FFM QHPs
CMS-10558
PRA Request for Comment
3/30/2015
Due date:
5/29/2015
Released:
3/20/2015
Published:
3/30/2015
Due date:
5/29/2015
Released:
3/30/2015
Due date:
5/29/2015
http://www.gpo.gov/fdsys/pkg/FR-2015-0330/pdf/2015-07089.pdf
Cooperative Agreement to Support
Navigators in Exchanges
CMS-10463
Released:
3/30/2015
Due date:
Roster key:
under Medicare for Stage 3 of the EHR Incentive Programs. It would continue
to encourage electronic submission of clinical quality measure (CQM) data for
all providers where feasible in 2017, propose to require the electronic
submission of CQMs where feasible in 2018, and establish requirements to
transition the program to a single stage for meaningful use. Finally, this Stage
3 proposed rule would change the EHR reporting period so that all providers
would report under a full calendar year timeline with a limited exception
under the Medicaid EHR Incentive Program for providers demonstrating
meaningful use for the first time. These changes together support broader
CMS efforts to increase simplicity and flexibility in the program while driving
interoperability and a focus on patient outcomes in the meaningful use
program.
This notice of proposed rulemaking introduces a new edition of certification
criteria (the 2015 Edition health IT certification criteria or “2015 Edition”),
proposes a new 2015 Edition Base Electronic Health Record (EHR) definition,
and proposes to modify the HHS ONC Health IT Certification Program to make
it open and accessible to more types of health IT and health IT that supports
various care and practice settings. The 2015 Edition also would establish the
capabilities and specify the related standards and implementation
specifications that Certified EHR Technology (CEHRT) would need to include
to, at a minimum, support the achievement of meaningful use by eligible
professionals (EPs), eligible hospitals, and critical access hospitals (CAHs)
under the Medicare and Medicaid EHR Incentive Programs (EHR Incentive
Programs) when these programs require the use of such edition.
1. Type of Information Collection Request: New collection; Title: Information
Collection for Machine Readable Data for Provider Network and Prescription
Formulary Content for FFM QHPs; Use: For plan years beginning on or after
January 1, 2016, qualified health plan (QHP) issuers must make available
provider and formulary data in a machine-readable format. As required by
the final rule titled “Patient Protection and Affordable Care Act; HHS Notice
of Benefit and Payment Parameters for 2016” (CMS-9944-F) and published in
the February 27, 2015, Federal Register (80 FR 10750), QHP issuers in the
Federally-Facilitated Marketplaces (FFMs) must publish information regarding
their formulary drug lists and provider directories on their Web site in an
HHS-specified format at times determined by HHS.
2. Type of Information Collection Request: Revision of a currently approved
collection; Title: Cooperative Agreement to Support Navigators in FederallyFacilitated and State Partnership Exchanges; Use: Section 1311(i) of ACA
requires Exchanges to establish a Navigator grant program as part of their
3/30/2015: Paperwork
Reduction Act notice.
No comments
recommended.
3/30/2015: Paperwork
Reduction Act notice.
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 18 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
PRA Request for Comment
5/29/2015
http://www.gpo.gov/fdsys/pkg/FR-2015-0330/pdf/2015-07089.pdf
Negotiation Cooperative Agreement
HHS-2015-IHS-TSGN-0001
Released:
2/18/2015
Office of Tribal Self-Governance; Negotiation
Cooperative Agreement
Due date:
6/3/2015
http://www.gpo.gov/fdsys/pkg/FR-2015-0218/pdf/2015-03235.pdf
Planning Cooperative Agreement
Applications
HHS-2015-IHS-TSGP-0001
Planning Cooperative Agreement
Applications: Tribal Self-Governance
Program
http://www.gpo.gov/fdsys/pkg/FR-2015-0220/pdf/2015-03206.pdf
Roster key:
Released:
2/20/2015
Due date:
6/3/2015
function to provide consumers with assistance when needed. Navigators will
assist consumers by providing education about and facilitating selection of
qualified health plans (QHPs) within Exchanges, as well as other required
duties. Section 1311(i) requires that an Exchange operating as of January 1,
2014, must establish a Navigator Program under which it awards grants to
eligible individuals or entities that satisfy the requirements of Exchange
Navigators. In States with a Federally-Facilitated Marketplace (FFM) or State
Partnership Marketplace (SPM), CMS will award these grants. Navigator
awardees must provide weekly, monthly, quarterly, and annual progress
reports to CMS on the activities performed during the grant period and any
sub-awardees receiving funds.
The IHS Office of Tribal Self-Governance (OTSG) seeks limited competition
Negotiation Cooperative Agreement applications for the Tribal SelfGovernance Program (TSGP). This program, authorized under Title V of the
Indian Self-Determination and Education Assistance Act (ISDEAA), provides
Tribes with resources to help defray costs related to preparing for and
conducting TSGP negotiations. TSGP negotiations require careful planning
and preparation by both tribal and federal parties, including the sharing of
precise, up-to-date information. The design of the negotiations process: (1)
Enables a Tribe to set its own priorities when assuming responsibility for IHS
PSFAs, (2) observes the government-to-government relationship between the
United States and each Tribe, and (3) involves the active participation of both
tribal and IHS representatives, including the OTSG. Because each tribal
situation is unique, a successful transition by a Tribe into the TSGP, or an
expansion of its current program, requires focused discussions between the
federal and tribal negotiation teams about the specific health care concerns
and plans of the Tribe.
The IHS Office of Tribal Self-Governance (OTSG) seeks limited competition
Planning Cooperative Agreement applications for the Tribal Self-Governance
Program (TSGP). This program, authorized under Title V of the Indian SelfDetermination and Education Assistance Act (ISDEAA), provides resources to
Tribes interested in entering TSGP and to existing Self-Governance Tribes
interested in assuming new or expanded Programs, Services, Functions and
Activities (PSFAs). Title V of ISDEAA requires a Tribe or tribal organization to
complete a planning phase to the satisfaction of the Tribe. The planning
phase must include legal and budgetary research and internal tribal
government planning and organization preparation relating to the
administration of health care programs.
No comments
recommended.
CFDA number: 93.444
Key dates:
--Application Deadline:
6/3/2015
--Review: 6/10/2015
--Earliest Anticipated Start:
7/1/2015
--Signed Tribal Resolutions
Due: 6/10/2015
CFDA number: 93.444
Key dates:
--Application Deadline:
6/3/2015
--Review: 6/10/2015
--Earliest Anticipated Start:
7/1/2015
--Signed Tribal Resolutions
Due: 6/10/2015
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 19 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
Tribal Management Grant Program
HHS-2015-IHS-TMD-0001
Released:
3/19/2015
Office of Direct Service and Contracting
Tribes; Tribal Management Grant Program
Due date:
6/3/2015
http://www.gpo.gov/fdsys/pkg/FR-2015-0319/pdf/2015-06353.pdf
Revisions to the Table for Calculating the
Premium Tax Credit, et al.
Rev. Proc. 2014-37
Revisions to the Table for Calculating the
Health Insurance Premium Tax Credit,
Updates to the Percentage for Determining
Qualification for Minimum Essential
Coverage, and Cross-Reference to the
Percentage for Determining Qualification for
Shared Responsibility Payment Exemption
http://www.irs.gov/pub/irs-drop/rp-1437.pdf
Released:
7/24/2014
Due date:
None
IHS seeks competitive grant applications for the Tribal Management Grant
(TMG) program, authorized under 25 U.S.C. 450h(b)(2) and 25 U.S.C. 450h(e)
of the Indian Health Self-Determination and Education Assistance Act
(ISDEAA), as amended. The TMG program, a competitive grant program,
helps federally-recognized Indian Tribes and Tribal organizations (T/TOs) to
assume all or part of existing IHS programs, functions, services, and activities
(PFSA) and further develop and improve their health management capability.
The TMG Program provides competitive grants to T/TOs to establish goals
and performance measures for current health programs; assess current
management capacity to determine the appropriateness of new components;
analyze programs to determine the practicality of T/TO management; and
develop infrastructure systems to manage or organize PFSA.
This revenue procedure provides indexing adjustments for certain provisions
under sections 36B and 5000A of the Internal Revenue Code. In particular, it
updates the Applicable Percentage Table in § 36B(b)(3)(A)(i). This table is
used to calculate the premium tax credit for an individual for taxable years
beginning after calendar year 2014. This revenue procedure also updates the
required contribution percentage in § 36B(c)(2)(C)(i)(II), which is used to
determine whether an individual qualifies for affordable employer-sponsored
minimum essential coverage under § 36B for plan years beginning after
calendar year 2014. Additionally, this revenue procedure cross-references the
required contribution percentage under § 5000A(e)(1)(A) for plan years
beginning after calendar year 2014, as determined under guidance issued by
HHS. This percentage is used to determine whether an individual qualifies for
an exemption from the individual shared responsibility payment because of a
lack of affordable minimum essential coverage.
CFDA number: 93.228
Key dates:
--Application Deadline:
6/3/2015
--Review: 6/22-26/2015
--Earliest Anticipated Start:
9/1/2015
--Signed Tribal Resolutions
Due: 6/19/2015
--Proof of Non-Profit Status
Due: 6/3/2015
7/30/2014: No comment
requested.
Associated with IRS REG104579-113 and TD-9863.
8/1: See analysis to the left.
Analysis:
For 2015 and subsequent years, adjustments to-1.
The percentages will be updated by the ratio of premium growth in
the preceding calendar year to income growth in the preceding
calendar year.
2.
Premium growth is measured by per enrollee spending for
employer-sponsored health insurance in the preceding year to per
enrollee spending in the calendar year two years prior.
3.
Income growth is measured by GDP per capita for the preceding
calendar year to the GDP per capita for the calendar year two years
Roster key:
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 20 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
4.
5.
6.
prior.
Adjustments are rounded to hundredth of a percentage point.
The adjusted percentages are applicable to tax years and plan years
after 2014.
The adjustment to each of the applicable percentages for 2015
approximates .0063 (or .63%, or two-thirds of one percent); the
effect of this adjustment is an increase in the percentages ranging
from .01 percentage points (from 2.00% to 2.01%) to .05 percentage
points (from 8.00% to 8.05%) to .06 percentage points (from 9.50%
to 9.56%).
Applicable percentage table
1.
Required contribution of household income used in calculating
amount of premium tax credit.
2.
In 2014, the applicable percentage table ranges from 2.0% to 9.5% of
household income.
3.
For 2015, IRS estimates the adjusted applicable percentage table will
range from 2.01% to 9.56%.
Required contribution percentage
1.
This measure is used to determine if someone is eligible for
affordable employer-sponsored health insurance.
2.
In 2014, the “required contribution percentage” is 9.5%.
3.
For 2015, IRS estimates the adjusted “required contribution
percentage” to be 9.56%.
Medicaid DSH Payments: Uninsured
Definition
CMS-2315-F
Medicaid Program; Disproportionate Share
Roster key:
Released:
12/3/2014
Due date:
None
Affordability percentage
1.
This measure is used to determine if someone is eligible for an
exemption due to health insurance options not being “affordable.”
2.
In 2014, the “affordability percentage” was defined as spending
more than 8% of household income.
3.
For 2015, IRS estimates the adjusted “affordability percentage” to be
8.05%.
[NOTE: CMS-9944-P identifies some of the applicable percentages for 2016.]
This final rule addresses the hospital-specific limitation on Medicaid
disproportionate share hospital (DSH) payments under the Social Security Act
(the Act). Under this limitation, DSH payments to a hospital cannot exceed
the uncompensated costs of furnishing hospital services by the hospital to
individuals who are Medicaid-eligible or “have no health insurance (or other
1/5/2015: See analysis to
the left comparing tribal
recommendations and the
final rule issued by CMS.
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 21 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
Hospital Payments--Uninsured Definition
http://www.gpo.gov/fdsys/pkg/FR-2014-1203/pdf/2014-28424.pdf
source of third party coverage) for the services furnished during the year.”
This rule provides that, in auditing DSH payments, CMS will apply the quoted
test on a service-specific basis; the calculation of uncompensated care for
purposes of the hospital-specific DSH limit will include the cost of each
service furnished to an individual by that hospital for which the individual had
no health insurance or other source of third party coverage.
Analysis:
NIHB submitted comments on the proposed version of this rule on February
17, 2012. A summary of the recommendations from NIHB, as well as the
responses from CMS in this final rule, appears below.
1.
Tribal Consultation: CMS did not engage in tribal consultation on the
proposed rule as required; CMS should engage in consultation with
AI/ANs prior to issuing the final rule.
2/4/2015: Doneg will check
with Carl Harper to see the
understanding of the
impact. Invite CMS to TTAG
to discuss this if it is a
problem.
3/12/2015: Requests are
pending with IHS on
whether IHS is currently
receiving Medicaid DSH
payments.
Response: Not accepted. According to CMS, “We solicited input on the
proposed rule from IHS, Tribal, and urban programs on March 16, 2012,
during an All Tribes’ Call. The purpose of the call was to solicit input
regarding how implementation or changes to regulatory provisions
would affect American Indians and Alaska Native beneficiaries and the
operation of the Indian health program delivery system.” [79 FR 71690]
2.
Treatment of IHS and Tribal Hospitals: When IHS and tribal hospitals
render services to IHS-eligible individuals, compensation for these
services is assumed, despite the acknowledged inadequacy of available
IHS funding, and these hospitals cannot include the cost of delivering
these services to otherwise uninsured individuals in their calculation of
uncompensated care, meaning that the proposed rule would effectively
exclude them from participation in the Medicaid DSH program; CMS
should address this issue in the final rule, possibly by extending to IHS
and tribal hospitals the regulatory protections under the Medicaid DSH
program for facilities that receive funding from a State or local
government.
Response: Not accepted. CMS stated, “The determining factor in
deciding whether an American Indian or Alaska Native has health
insurance for an inpatient or outpatient hospital service is if the
providing entity is an IHS facility or tribal health program. In the case of
Roster key:
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 22 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
contract services, the coverage of the services is specifically authorized
via a purchase order or equivalent document because individuals in these
circumstances are considered to have a source of third party payment.
The cost of services and any revenues received would be excluded from
the DSH calculation. Individuals obtaining inpatient or outpatient hospital
services from a non-IHS or tribal facility without a purchase order (or
other authorization) would be considered uninsured for these services.
The costs of these services and revenues received could be included in
the DSH limit calculation.” [79 FR 71689]
In addition, CMS stated, “An American Indian or Alaska Native would be
considered to have no health insurance when he or she obtains services
without a purchase order or equivalent authorization to pay for them. If
contract providers have provided needed services that were not
pursuant to a purchase order, the American Indian or Alaska Native
would be considered uninsured (absent private coverage) and the costs
and any revenues associated with these services could be included in the
limit.” [79 FR 71689-90]
CMS also noted that the recommendation to treat IHS and tribal
hospitals similarly to “a State or unit of local government within a State”
falls outside the scope of the rule. [79 FR 71690]
3.
Use of HIPAA Definition of Creditable Coverage: The proposed rule uses
the HIPAA definition of creditable coverage; CMS should not use this
definition, which is neither required nor, in the case of services rendered
to IHS-eligible individuals, warranted, as it results in considering IHPs
rendering services to IHS-eligible persons as fully compensated for these
services without regard to the level of available IHS funding.
Response: Accepted in part. CMS stated, “In this final rule, we are
defining “individuals who have no health insurance (or other source of
third party coverage) for the services furnished during the year” for
purposes of calculating the hospital-specific DSH limit on a servicespecific basis, rather than on an individual basis, and thus do not make
reference to the regulatory definition of creditable coverage. The
definition instead requires a determination of whether, for each specific
service furnished during the year, the individual has third party
coverage.” [79 FR 71690]
Roster key:
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 23 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
Additional Requirements for Charitable
Hospitals
TD 9708
Additional Requirements for Charitable
Hospitals; Community Health Needs
Assessments for Charitable Hospitals;
Requirement of a Section 4959 Excise Tax
Return and Time for Filing the Return
http://www.gpo.gov/fdsys/pkg/FR-2014-1231/pdf/2014-30525.pdf
Released:
12/31/2014
Due date:
None
This document contains final regulations that provide guidance regarding the
requirements for charitable hospital organizations added by ACA. These final
regulations will affect charitable hospital organizations.
These final regulations provide guidance on the requirements described in
section 501(r), the entities that must meet these requirements, and the
reporting obligations relating to these requirements under section 6033. In
addition, the final regulations provide guidance on the consequences
described in sections 501(r)(1), 501(r)(2)(B), and 4959 for failing to satisfy the
section 501(r) requirements.
1/7/2015: See analysis to
the left comparing the tribal
recommendation and the
final rule issued by IRS.
Analysis:
This rule finalizes REG-130266-11, issued on June 26, 2012, and REG-10649912, issued on April 5, 2013.
ANTHC submitted comments on REG-130266-11 on September 24, 2012. A
summary of the recommendation from ANTHC, as well as the response from
IRS in this final rule, appears below.
Hospitals Operated by Tribes: The proposed rule should expressly clarify that
hospitals operated by tribes or tribal organizations, even as part of a 501(c)(3)
organization, are exempt from its application to avoid ambiguity on this issue.
Based on its definitions of “hospital facility” and “hospital organization,” the
rule applies solely to entities recognized or seeking to be recognized as tax
exempt under 26 U.S.C. § 501(c)(3) that operate a facility required by a state
to be licensed, registered, or similarly recognized as a hospital. No states have
asserted their authority to require a license of a tribal hospital facility, and
the Indian Self-Determination and Education Assistance Act of 1975 and
subsequent amendments, as well as the Indian Health Care Improvement Act,
pre-empt any state authority in this area.
Response: Not addressed this rule; accepted in other rule.
IRS accepted this recommendation previously. In the preamble to REG106499-12, IRS clarified that, “pending any future guidance regarding other
categories of hospital organizations or facilities, a tribal facility that is not
required by a state to be licensed, registered, or similarly recognized as a
hospital is not a ‘hospital facility’ for purposes of section 501(r), and a section
Roster key:
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 24 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
Annual Update of the HHS Poverty
Guidelines
HHS (no reference number)
Annual Update of the HHS Poverty
Guidelines
Released:
1/22/2015
Due date:
None
http://www.gpo.gov/fdsys/pkg/FR-2015-0122/pdf/2015-01120.pdf
501(c)(3) organization will not be considered a ‘hospital organization’ solely
as a result of operating such a tribal facility.” [78 FR 20525]
This notice provides an update of the HHS poverty guidelines to account for
the increase in prices as measured by the Consumer Price Index for the last
calendar year.
A table comparing the 2015 HHS poverty guidelines with the 2014 guidelines
is embedded below.
HHS Poverty
Guidelines 2014-2015 Table.docx
TSGAC Handout attached.
TSGAC Revised- 2015
FPL Handout - Medicaid and Marketplace 2015-01-23a.pdf
Penalty Relief Related to Advance
Payments of the Premium Tax Credit
Notice 2015-9
Released:
1/26/2015
1/22/2015: No response
required/requested.
These poverty level figures
will be used for Medicaid
eligibility determinations for
the remainder of 2015 and
until revised FPL guidelines
are issued in 2016. (The
Marketplace will continue to
use the 2014 FPL guidelines
for 2015 QHP enrollment.)
Handout on use of 2015 FPL
linked to the left.
This notice provides limited relief for taxpayers who have a balance due on
their 2014 income tax return as a result of reconciling advance payments of
1/31/2015: No comments
the premium tax credit against the premium tax credit allowed on the tax
requested or
Due date:
return. Specifically, this notice provides relief from the penalty under §
recommended.
Penalty Relief Related to Advance Payments
None
6651(a)(2) of the Internal Revenue Code for late payment of a balance due
of the Premium Tax Credit for 2014
and the penalty under § 6654(a) for underpayment of estimated tax. To
qualify for the relief, taxpayers must meet certain requirements described in
http://www.irs.gov/pub/irs-drop/n-15this notice. This relief applies only for the 2014 taxable year.
09.pdf
 The § 6651(a)(2) penalty is not imposed if the taxpayer shows that
the failure was due to reasonable cause and not willful neglect.
 the Service will abate the § 6651(a)(2) penalty for taxable year 2014
for taxpayers who (i) are otherwise current with their filing and
payment obligations; (ii) have a balance due for the 2014 taxable
year due to excess advance payments of the premium tax credit; and
(iii) report the amount of excess advance credit payments on their
2014 tax return timely filed, including extensions
 the Service will waive the § 6654 penalty for taxable year 2014 for an
underpayment of estimated tax for taxpayers who have an
underpayment attributable to excess advance credit payments if the
taxpayers (i) are otherwise current with their filing and payment
obligations; and (ii) report the amount of the excess advance credit
Roster key: Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 25 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
payments on a 2014 tax return timely filed, including extensions

Taxpayers should be aware that this Notice does not extend
the time to file a return.

Additionally, § 6601 imposes interest on amounts of tax not paid by
the due date, determined without regard to an extension of time for
payment. Taxpayers will be required to pay interest on the balance
due from the original deadline to pay, which is generally April 15,
2015, even if they qualify for penalty relief under this Notice.
Taxpayers who file their returns after April 15, 2015 must fully pay
the underlying liability by April 15, 2016 to be eligible for relief under
this Notice. Interest will accrue until the underlying liability is fully
paid.
To request a waiver of the § 6654(a) penalty as provided in this
Notice, taxpayers should check box A in Part II of Form 2210,
complete page 1 of the form, and include the form with their return,
along with the statement: “Received excess advance payment of the
premium tax credit.”


Special Protections for AI/ANs
CMS (no reference number)
Released:
1/27/2015
Health Insurance Marketplace Protections
for American Indians and Alaska Natives
Due date:
None
http://www.cms.gov/Outreach-andEducation/American-Indian-AlaskaNative/AIAN/Downloads/AIANsSpecialProtections-Fact-Sheet.pdf
AI/AN Trust Income and MAGI
CMS (no reference number)
Released:
1/27/2015
American Indian and Alaska Native
Trust Income and MAGI
Due date:
None
Roster key:
This relief does not apply to any underpayment of the individual shared
responsibility payment resulting from the application of § 5000A because
such underpayments are not subject to either the § 6651(a)(2) penalty or the
§ 6654(a) penalty.
This fact sheet explains the protections for AI/ANs in the Marketplace,
Medicaid, and CHIP. This fact sheet addresses special enrollment periods,
zero and limited cost-sharing plans, Medicaid and CHIP protections, and
Indian-specific exemptions.
1/26/2015: Handout
prepared and released by
CMS on Indian-specific
benefits and protections
under the ACA and
Medicaid.
No response requested.
This fact sheet describes Modified Adjusted Gross Income (MAGI) and what
that means for AI/AN Trust Income. This fact sheet includes frequently asked
questions and answers and a list of specific types of AI/AN exempt income.
1/26/2015: Handout
prepared and released by
CMS on Indian-specific
income provisions under the
ACA, Medicaid and federal
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 26 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
http://www.cms.gov/Outreach-andEducation/American-Indian-AlaskaNative/AIAN/Downloads/AIAN-TrustIncome-and-MAGI-FactSheet.pdf
FAQ About Excepted Benefits
CCIIO (no reference number)
Released :
2/13/2015
FAQs About Affordable Care Act
Implementation: Excepted Benefits
Due date:
None
http://www.cms.gov/CCIIO/Resources/FactSheets-and-FAQs/Downloads/SupplmentalFAQ_2-13-15-final.pdf
law.
No response requested
This guidance, prepared jointly by HHS and the Departments of Labor and the
Treasury (collectively, the Departments), answers an additional Frequently
Asked Question (FAQ) regarding implementation of ACA, specifically
addressing the issue of excepted benefits. The Departments have become
aware of health insurance issuers selling supplemental products that provide
a single benefit. At least one issuer has characterized this type of coverage as
an excepted benefit. These issuers claim that the products meet the criteria
for supplemental coverage to qualify as an excepted benefit outlined in
guidance and seek to fill the gaps of primary coverage in the sense that they
provide a benefit not covered under the primary group health plan. This
guidance answers the question of whether health insurance coverage that
supplements group health coverage by providing additional categories of
benefits qualifies as supplemental excepted benefits. According to this
guidance:
2/20/2015: No comments
requested or
recommended.
“It depends. The Departments’ prior guidance provided an enforcement safe
harbor for supplemental insurance products that are specifically designed to
fill gaps in primary coverage, such as coinsurance or deductibles. In
determining whether insurance coverage sold as a supplement to group
health coverage can be considered ‘similar supplemental coverage’ and an
excepted benefit, the Departments will continue to apply the applicable
regulations and the four criteria indicated in the guidance discussed above. In
addition, the Departments intend to propose regulations clarifying the
circumstances under which supplemental insurance products that do not fill
in cost-sharing under the primary plan are considered to be specifically
designed to fill gaps in primary coverage. Specifically, the Departments intend
to propose that coverage of additional categories of coverage would be
considered to be designed to ‘fill in the gaps’ of the primary coverage only if
the benefits covered by the supplemental insurance product are not an
essential health benefit (EHB) in the State where it is being marketed. If any
benefit in the coverage is an EHB in the State where it is marketed, the
insurance coverage would not be an excepted benefit under our intended
proposed regulations, and would have to comply with the applicable
provisions of title XXVII of PHS Act, part 7 of ERISA, and chapter 100 the Code.
Roster key:
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 27 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
We note that this standard applies to coverage that purports to qualify as an
excepted benefit as ‘similar supplemental coverage provided to coverage
under a group health plan’ under PHS Act section 2791(c)(4), ERISA section
733(c)(4), and Code section 9832(c)(4). This standard does not apply to other
circumstances where the coverage may qualify as another category of
excepted benefits, such as limited excepted benefits under section
2791(c)(2), ERISA section 733(c)(2), and Code section 9832(c)(2).
Application of Code § 4980D to Certain
Health Coverage Arrangements
Notice 2015-17
Guidance on the Application of Code §
4980D to Certain Types of Health Coverage
Reimbursement Arrangements
http://www.irs.gov/pub/irs-drop/n-1517.pdf
Roster key:
Released :
2/17/2015
Due date:
None
Pending publication and finalization of the above proposed regulations, the
Departments will not initiate an enforcement action if an issuer of group or
individual health insurance coverage fails to comply with the provisions of the
PHS Act, ERISA, and the Code, as amended by the Affordable Care Act, with
respect to health insurance coverage that (1) provides coverage of additional
categories of benefits that are not EHB in the applicable State (as opposed to
filling in cost-sharing gaps under the primary plan); (2) complies with the
applicable regulatory requirements and meets all of the criteria in the existing
guidance on ‘similar supplemental coverage’; and (3) has been filed and
approved with the State (as may be required under State law). As noted
above, for purpose of the second criterion of the existing guidance, coverage
would be considered designed to ‘fill gaps in primary coverage’ even if it does
not include coverage of cost-sharing under the group health plan, only if the
benefits are not covered by the group health plan and are not EHBs in the
State. The Departments encourage States that have primary enforcement
authority over the provisions of the PHS Act, as amended by the Affordable
Care Act, to utilize the same enforcement discretion under such
circumstances.”
This notice reiterates the conclusion in previous guidance addressing
employer payment plans, including Notice 2013-54, that employer payment
plans are group health plans that will fail to comply with the market reforms
that apply to group health plans under ACA. For this purpose, an employer
payment plan as described in Notice 2013-54 refers to a group health plan
under which an employer reimburses an employee for some or all of the
premium expenses incurred for an individual health insurance policy or
directly pays a premium for an individual health insurance policy covering the
employee, such as arrangements described in Revenue Ruling 61-146. This
notice also provides transition relief from the assessment of excise tax under
Internal Revenue Code (Code) § 4980D for failure to satisfy market reforms in
certain circumstances. The transition relief applies to employer health care
arrangements that constitute (1) employer payment plans, as described in
REVIEW.
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 28 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
Notice 2013-54, if the plan is sponsored by an employer that is not an
Applicable Large Employer (ALE) under Code § 4980H(c)(2) and §§54.4980H1(a)(4) and -2; (2) S corporation health care arrangements for 2-percent
shareholder-employees; (3) Medicare premium reimbursement
arrangements; and (4) TRICARE-related health reimbursement arrangements
(HRAs). This notice also provides additional guidance on the tax treatment of
employer payment plans. This notice supplements and clarifies the guidance
provided in Notice 2013-54 and other guidance in response to comments and
questions from taxpayers and stakeholder groups about certain aspects of
that guidance.
2016 Letter to Issuers in FFMs
CCIIO (no reference number)
Released:
2/20/2015
Final 2016 Letter to Issuers in the FederallyFacilitated Marketplaces
Due date:
None
http://www.cms.gov/CCIIO/Resources/Regul
ations-andGuidance/Downloads/2016_Letter_to_Issue
rs_2_20_2015.pdf
This final 2016 Letter to Issuers in the Federally-Facilitated Marketplaces
(Letter) provides issuers seeking to offer qualified health plans (QHPs),
including stand-alone dental plans (SADPs), in the Federally-Facilitated
Marketplaces (FFMs) or the Federally-Facilitated Small Business Health
Options Programs (FF-SHOPs) with operational and technical guidance to help
them successfully participate in those Marketplaces in 2016. Unless
otherwise specified, references to the FFMs include the FF-SHOPs.
2/25/2015: See analysis of
final rule (as compared to
tribal recommendations) to
the left.
Throughout this Letter, CMS identifies the areas in which States performing
plan management functions in the FFMs have flexibility to follow an approach
different from that articulated in this guidance. CMS notes that the policies
articulated in this Letter apply to the certification process for plan years
beginning in 2016.
Previously published rules concerning market-wide and QHP certification
standards, eligibility and enrollment procedures, and other Marketplacerelated topics appear in 45 CFR Subtitle A, Subchapter B. Additional
requirements appear in a final rule titled, “Patient Protection and Affordable
Care Act; HHS Notice of Benefit and Payment Parameters for 2016” (2016
Payment Notice Final Rule), CMS-9944-F, released on February 20, 2015.
CMS expects issuers to consult all applicable regulations, in conjunction with
the final version of this Letter, to ensure full compliance with the
requirements of ACA. Throughout the plan year, QHPs might have to correct
deficiencies identified in CMS post-certification activities, as a result of the
investigation of consumer complaints or oversight by State regulators or by
CMS, or in response to an industry-standard internal compliance and risk
management program. QHP issuers in the FFMs also might have other
requirements for plan years beginning in 2016, as indicated in future
Roster key:
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 29 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
rulemaking.
Analysis:
TTAG submitted comments on the draft version of this letter on January 12,
2015. A summary of the recommendations from TTAG, as well as the
responses from CMS in this final letter, appears below.
1.
Application of Requirements Related to Indian Health Providers (IHPs):
The requirements in the 2016 Issuer Letter apply solely to issuers when
offering qualified health plans (QHPs) through the Federally-Facilitated
Marketplace (FFM); CMS should extend these requirements to issuers
when offering QHPs in State-Based Marketplaces.
Response: Not accepted.
2.
Special Enrollment Period for Tax Season
CMS (no reference number)
Released:
2/20/2015
CMS Announces Special Enrollment Period
for Tax Season
Due date:
None
http://www.cms.gov/Newsroom/MediaRele
aseDatabase/Press-releases/2015-Pressreleases-items/2015-02-20.html
Roster key:
Requirement for Issuers to Offer Contracts to IHPs: The draft 2016
Issuer Letter does not retain a provision in the 2015 Issuer Letter (page
20) requiring issuers--in cases in which they fail to 30 percent essential
community provider (ECP) guideline--to attest in a narrative justification
to having made good faith contract offers to all IHPs in a QHP service
area and instead states on page 26, “If an issuer’s application does not
satisfy the 30 percent ECP standard as well as the requirement to offer
contracts in good faith to all available Indian health providers in the
service area,” the issuer must provide a narrative justification (emphasis
added); CMS should delete the italicized phrase, as it would allow an
issuer to offer a QHP through the FFM without having made good faith
contract offers to all available IHPs.
Response: Not accepted. CMS finalized this statement as proposed.
This press release announces a special enrollment period (SEP) for individuals
who did not have health coverage in 2014 and face the fee or “shared
responsibility payment” when they file their 2014 taxes in states using the
Federally-Facilitated Marketplace (FFM). This SEP period will allow these
individuals who were unaware or did not understand the implications of this
new requirement to enroll in 2015 health insurance coverage through the
FFM from March 15 to April 30.
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 30 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
Basic Health Program Federal Funding
Methodology for PY 2016
CMS-2391-FN
Basic Health Program; Federal Funding
Methodology for Program Year 2016
http://www.gpo.gov/fdsys/pkg/FR-2015-0224/pdf/2015-03662.pdf
Released:
2/20/2015
Published:
2/24/2015
REVIEW.
Due date:
None
Corrected Form 1095-As
CMS (no reference number)
Released:
2/20/2015
What Consumers Need to Know about
Corrected Form 1095-As
Due date:
None
http://blog.cms.gov/2015/02/20/whatconsumers-need-to-know-about-correctedform-1095-as/
This document provides the methodology and data sources necessary to
determine federal payment amounts made in program year 2016 to states
that elect to establish a Basic Health Program under ACA to offer health
benefits coverage to low-income individuals otherwise eligible to purchase
coverage through the Affordable Insurance Exchanges.
This blog post provides information for the 20 percent of tax filers who had
Federally-Facilitated Marketplace coverage in 2014, used tax credits to lower
their premium costs, and received a Form 1095-A with incorrect information.
According to this post, these 800,000 individuals (< 1 percent of total tax
filers) will receive an updated Form 1095-A because the original version they
received listed an incorrect benchmark plan premium amount. This post
recommends that Marketplace consumers concerned about the status of
their Form 1095-A should take the following actions:
1.
2.
3.
FYI. No action needed.
Determine whether they are affected by logging in to their account at
HealthCare.gov;
If they received a form with incorrect information, wait to file their tax
return until they receive a corrected form; and
If they need to file their tax return immediately, use the online tool or call
the Marketplace Call Center at 1-800-318-2596 to determine the correct
amount of the second-lowest-cost silver plan that applied to their
household in 2014.
More information on this issue, as well as a link to the online tool, is available
at https://www.healthcare.gov/blog/is-your-form-1095a-correct/.
An FAQ document for assisters about this issue is available at
https://marketplace.cms.gov/technical-assistance-resources/slc-silverplan.pdf.
Press coverage of this blog post is available at
http://www.manatt.com/health-reform-weekly-highlights-2-24-15.aspx.
Roster key:
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 31 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
Modifications to the Multi-State Plan
Program for Exchanges
OPM (RIN 3206-AN12)
Patient Protection and Affordable Care Act;
Establishment of the Multi-State Plan
Program for the Affordable Insurance
Exchanges
Released:
2/24/2015
Due date:
None
http://www.gpo.gov/fdsys/pkg/FR-2015-0224/pdf/2015-03421.pdf
Health Insurance Providers Fee
TD 9711
Released:
2/26/2015
Health Insurance Providers Fee
Due date:
None
http://www.gpo.gov/fdsys/pkg/FR-2015-0226/pdf/2015-03944.pdf
HHS Notice of Benefit and Payment
Parameters for 2016
CMS-9944-F
Patient Protection and Affordable Care Act;
HHS Notice of Benefit and Payment
Parameters for 2016
Roster key:
Released:
2/20/2015
Published:
2/27/2015
Due date:
None
This final rule implements modifications to the Multi-State Plan (MSP)
Program based on the experience of the program to date. OPM established
the MSP Program pursuant to ACA. This final rule clarifies the approach used
to enforce the applicable standards of ACA with respect to health insurance
issuers that contract with OPM to offer MSP options; amends MSP standards
related to coverage area, benefits, and certain contracting provisions under
section 1334 of ACA; and makes non-substantive technical changes.
NOTE: Tribal organizations made 16 recommendations on the OPM rule that
initially established the Multi-State Plan Program (MSPP). In a final rule issued
on March 11, 2013, OPM accepted only one of these recommendations in full
but either accepted in part or acknowledged by other means most of the
others; the rule did not address four of the recommendations. In the Q1 FY
2015 NIHB evaluation report, a comparison of the proposed version to this
latest final rule with the unaccepted recommendations previously
categorized as having “potential for future actions” indicated that OPM had
not addressed any of these recommendations. The proposed rule also
included no Indian-specific provisions. A prior analysis of the proposed rule
recommended that tribal organizations consider commenting on a proposal
to delete the requirement that contracting MSP providers submit a plan for
statewide coverage when their coverage in a state is not currently statewide,
as this change likely would impact coverage options in rural and underserved
areas; tribal organizations opted not to comment.
This document contains temporary regulations that provide rules for the
definition of a covered entity for purposes of the fee imposed by section 9010
of ACA. The temporary regulations clarify certain terms in section 9010. The
temporary regulations affect persons engaged in the business of providing
health insurance for U.S. health risks. The text of the temporary regulations
also serves as the text of the proposed regulations (REG-143416-14)
published in elsewhere in this issue of the Federal Register.
This final rule sets forth payment parameters and provisions related to the
risk adjustment, reinsurance, and risk corridors programs; cost-sharing
parameters and cost-sharing reductions; and user fees for FederallyFacilitated Exchanges. It also finalizes additional standards for the individual
market annual open enrollment period for the 2016 benefit year, essential
health benefits, qualified health plans, network adequacy, quality
improvement strategies, the Small Business Health Options Program,
guaranteed availability, guaranteed renewability, minimum essential
3/20/2014: Summary
embedded below.
REG-143416-14
analysis 2015-03-18.docx
2/25/2015: See analysis of
final rule (as compared to
tribal recommendations) to
the left
3/18/2015: The two
highlighted issues (family
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 32 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
http://www.gpo.gov/fdsys/pkg/FR-2015-0227/pdf/2015-03751.pdf
coverage, the rate review program, the medical loss ratio program, and other
related topics.
A CCIIO fact sheet on this final rule is available at
http://www.cms.gov/CCIIO/Resources/Fact-Sheets-andFAQs/Downloads/2016-PN-Fact-Sheet-final.pdf.
tag-along policy and family
plans/cost-sharing
protections) will be added
to the ACA Policy
Subcommittee agenda.
Analysis:
TTAG submitted comments on the proposed version of this rule on December
22, 2014. A summary of the recommendations from TTAG, as well as the
responses from CMS in this final rule, appears below.
1.
Requirement on Summary of Benefits and Coverage (SBC): The
proposed rule would establish a requirement that QHP issuers prepare an
SBC for each plan variation, such as the “zero cost-sharing variation” and
the “limited cost-sharing variation”; in regard to this requirement, CMS
should:



Roster key:
a. Retention: Retain this requirement, as to date, information on
Indian-specific cost-sharing protections provided by issuers to
consumers, if any, often proves confusing or incorrect, prompting
some AI/ANs to decide not to enroll in coverage through a
Marketplace;
b. Encouraging Issuer Compliance: Encourage issuers to prepare
SBCs for use during the 2015 benefit year but no later than the first
day of the Marketplace open enrollment period for the 2016 benefit
year;
c. Regulatory Cross-Reference: Add a cross-reference to the
requirement to prepare an SBC in the regulation on SBCs (45 §
147.200) by inserting in §147.200 the following language (in brackets
and bold): Ҥ147.200 Summary of benefits and coverage and uniform
glossary. (a) Summary of benefits and coverage--(1) In general. A
group health plan (and its administrator as defined in section
3(16)(A) of ERISA), and a health insurance issuer offering group or
individual health insurance coverage, is required to provide a written
summary of benefits and coverage (SBC) for [each plan variation of]
each benefit package [, as indicated in §156.420(h)] without charge
to entities and individuals described in this paragraph (a)(1) in
accordance with the rules of this section”; and
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 33 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015

d. Examples Regarding Compliance: In the preamble to the final
rule, and in subsequent guidance documents, provide examples of
when QHP issuers must provide SBCs to comply with the
requirements set forth in § 147.200 and § 156.420(h) and the
circumstances, if any, under which a single SBC can satisfy the
requirement for multiple plans.
Response:




2.
a. Retention: Accepted. CMS approved this provision as proposed;
b. Encouraging Issuer Compliance: Accepted in part. CMS approved
the requirement that QHP issuers provide SBCs for plan variations no
later than the first day of the next Marketplace open enrollment
period for the individual market for the 2016 benefit year, specifying
this date as November 1, 2015;
c. Regulatory Cross-Reference: Not accepted. CMS did not modify §
147.200 in the final rule; and
d. Examples Regarding Compliance: Not accepted. CMS did not
address this issue.
Hardship Exemption: The proposed rule includes a provision that would
codify the newly established process for obtaining the hardship
exemption from the tax penalty for IHS-eligible individuals; in regard to
this provision, CMS should:


a. Retention: Retain this provision (§ 155.605(g)(6)(iii)), which would
make agency regulations consistent with revised IRS regulations; and
b. Paper-Based Application Process: Refocus attention on fixing the
paper-based exemption application process through FederallyFacilitated Marketplaces by allocating sufficient resources and
making the current status of individual applications--as well as
applications in the aggregate--more transparent.
Response:

Roster key:
a. Retention: Accepted. CMS approved this provision as proposed;
and
 b. Paper-Based Application Process: Not accepted. CMS did not
address this issue specifically but stated, “We remain committed to
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 34 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
improving the Exchange exemptions process” [80 FR 10802].
3.
Code Citation to Definition of Indian Under Medicaid: The proposed rule
includes a provision that would amend § 155.605(g)(6)(i) by changing the
citation from 42 § 447.50 to 42 § 447.51, which cross-references the
definition of Indian used for Medicaid purposes; CMS should retain this
provision.
Response: Accepted. CMS approved this provision as proposed.
4.
Network Adequacy and Essential Community Provider Provisions: The
proposed rule would codify some of the network adequacy and essential
community provider (ECP) provisions that appear in the CCIIO 2015 Issuer
Letter and apply solely under the FFM, including 1) codifying the
requirement that QHP issuers offer contracts to all Indian health care
providers (IHCPs), 2) requiring/encouraging “good faith” offers pertaining
to payment rates, 3) adding a requirement that QHP-IHCP contracts apply
the special terms and conditions under Federal law pertaining to IHCPs
(contained in the QHP Addendum), and 4) applying the requirement that
QHP issuers offer contracts to IHCPs; in regard to these provisions, CMS
should:




Roster key:
a. Retention: Retain the requirement that QHP issuers offer
contracts to all IHCPs in the QHP service area;
b. 30 Percent ECP Standard: At a minimum, maintain the minimum
standard of contracting with at least 30 percent of available ECPs
until such time as quantitative evidence indicates that enrollees have
reasonable and timely access to health care services;
c. “Good Faith” Contract Offers: Retain the provision requiring
“good faith” contract offers to IHCPs, but 1) clarify that the minimum
payment rate provision exists as a requirement rather than an
“expectation” and 2) include the minimum payment rate
requirement in the final regulations, rather than limiting it to the
preamble;
d. QHP Addendum Language: Modify the language referencing the
QHP Addendum to make it consistent with the wording of the CCIIO
2015 Issuer Letter, as the proposed rule appears to require
application of the Indian-specific provisions in Federal law but not
(as required in the CCIIO 2015 Issuer Letter) actual use of the
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 35 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015


Addendum;
e. “Alternative Standard” for Issuers: Strengthen the “alternative
standard” for QHP issuers to comply with ACA requirements by 1)
adding a requirement that they indicate efforts taken to date to
meet the ECP standard and 2) making publicly available their
narrative description of efforts taken to date, as well as their plan on
“how the plan’s provider network will be strengthened toward
satisfaction of the ECP standard prior to the start of the benefit
year”; and
f. State-Based Marketplace (SBM) Standards: Add language to the
preamble of the final rule “urging” SBMs to apply the IHCP
contracting standards to QHPs offered through SBMs.
Response:


Roster key:
a. Retention: Accepted. CMS approved this provision as proposed;
b. 30 Percent ECP Standard: Accepted. CMS approved this provision
as proposed. According to CMS, “Based on our QHP certification
reviews for the 2015 benefit year and the ongoing strengthening of
our ECP list, we believe that specifying the ECP inclusion percentage
in HHS guidance for the 2016 benefit year provides desirable
flexibility at this time for HHS further examine the adequacy of this
inclusion standard for ensuring access to care for low-income,
medically underserved individuals for future years” [80 FR 10835];
 c. “Good Faith” Contract Offers: Accepted in part. CMS approved
this provision as proposed and stated, “We do not intend to
prescribe such specificity regarding contract negotiations between
parties. Therefore, we are not requiring a minimum payment rate
provision, and instead reiterate our expectation that QHP issuers
offer contracts in good faith” [80 FR 10838]. In addition, CMS
codified the inclusion of IHCPs in the definition of ECP to “emphasize
that these providers are among the ECP groups to which issuers
must extend contract offers in good faith to satisfy §156.235(a)” [80
FR 10835];
 d. QHP Addendum Language: Not accepted. According to CMS, “We
believe the requirement that issuers apply the special terms and
conditions necessitated by Federal law and regulations as referenced
in the recommended model QHP addendum, along with encouraging
issuer use of the recommended model QHP addendum in guidance,
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 36 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015


5.
strikes the desirable balance between allowing the minimal flexibility
that issuers have requested while ensuring inclusion of the
fundamental provisions of the model QHP addendum within the
issuer contractual offers to the Indian health providers. Therefore,
while we strongly encourage issuers to use the model QHP
Addendum, we are not requiring that they do so” [80 FR 10836];
e. “Alternate Standard” for Issuers: Not accepted. CMS modified
this provision but did not address the recommended requirements;
and
f. State-Based Marketplace (SBM) Standards: Accepted. CMS
stated, “We urge State Exchanges to employ the same standard
when examining adequacy of ECPs as outlined in §156.235, including
the requirement that issuers offer contracts to all Indian health
providers in the plan’s service area” [80 FR 10837].
Application of Cost-Sharing Protections for AI/AN Families: Responses
from CMS to earlier comments from tribal organizations indicated a
willingness to address problems with the application of cost-sharing
protections for families with AI/AN and non-AI/AN members beginning
with the 2016 benefit year, but the proposed rule does not address this
issue; in regard to this concern, CMS should 1) implement tribal
recommendations (made on CMS-9964-P in December 2012) to eliminate
the potential for an increase in the aggregate premiums and to prevent
shifting of out-of-pocket (OOP) liabilities to non-Indian family members
or 2) provide as an administrative convenience the ability of other IHSeligible family members to enroll in the same zero cost-sharing variation
or limited cost-sharing variation in which Indian members of the family
qualify.
Response: Not accepted.* CMS did not address this issue.
*NOTE: On an ACA Policy Subcommittee call on 2/26/2015, Kitty Marx
indicated this issue was addressed in the final rule. She indicated it was
addressed in a way that is applicable to all families (not solely Indians)
that have persons eligible for different cost-sharing protections. Citation
to be provided.
6.
Roster key:
AI/AN Family Tag-Along Policy: At the request of tribal organizations,
CCIIO issued guidance to enrollment assisters on November 15, 2014,
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 37 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
indicating that family members of individuals eligible for the Monthly
Special Enrollment Period (SEP) for Indians can enroll in Marketplace
coverage with the eligible individuals, and although the proposed rule
would make several modifications to SEP regulations (§155.420), it would
not codify this provision; in regard to this provision, CMS should add this
provision to the final rule by inserting in §155.420(d)(8) the following
language (in bold): “(8) The qualified individual who is an Indian, as
defined by section 4 of the Indian Health Care Improvement Act, or his or
her dependent, may enroll in a QHP or change from one QHP to another
one time per month.”’
Response: Not accepted. From the entry by CMS in the regulation
preamble, CMS seemed to pull-back from existing CMS policy whereby
dependents may access the Indian-specific special enrollment period if a
family meets the eligibility requirements. (Kitty Marx stated on an ACA
Policy Subcommittee call that the exist CCIIO guidance on this would stay
in effect.) CMS stated, “An Indian as provided under section 4(d) of the
Indian Self Determination and Education Assistance Act (ISDEAA) and
section 4 of the Indian Health Care Improvement Act (IHCIA) is defined as
an individual who is a member of an Indian tribe. Both ISDEAA and IHCIA
have nearly identical language that refers to a number of Indian entities
that are included in this definition on the basis that they are recognized
as eligible for the special programs and services provided by the United
States to Indians because of their status as Indians. As such, the statute
specifically provides the special enrollment period defined in paragraph
(d)(8) of this section as applying to the individual who is eligible for
special programs and services because of their status as an Indian, and
not their dependents” [80 FR 10799].
7.
Maximum Out-of-Pocket Costs for Individuals: The proposed rule
includes language clarifying (for the 2016 benefit year and beyond) that
the annual limitation on cost-sharing for self-only coverage applies to all
individuals, regardless of whether the individual is covered by a self-only
plan or a family plan, with the limit let at $6,850 in 2016; CMS should
retain this provision.
Response: Accepted. CMS approved this provision as proposed.
Roster key:
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 38 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
Other Points of Interest:

Contract Offers to IHCPs: One (non-tribal representative)
commenter recommended that, “if issuers met the ECP standard in
the previous year, issuers not be required every year to offer
contracts to all Indian health care providers in the service area and
to at least one ECP in each ECP category in each county in the service
area” [80 FR 10836-7].
Response: Retained provision as preferred by tribal representatives.

Additional Requirements for Charitable
Hospitals
TD 9708
Additional Requirements for Charitable
Hospitals; Community Health Needs
Assessments for Charitable Hospitals;
Requirements of a Section 4959 Excise Tax
Return and Time for Filing the Return;
Correction
http://www.gpo.gov/fdsys/pkg/FR-2015-0311/pdf/2015-05519.pdf
Roster key:
Released:
3/11/2015
Due date:
None
Removal of IHCPs as ECPs: One (non-tribal representative)
commenter recommended that CMS remove IHCPs as a major ECP
category “due to the overlapping requirement that issuers offer
contracts to all Indian health providers in the service area” [80 FR
10837].
Response: Retained provision as preferred by tribal representatives.
This document contains corrections to final regulations (TD 9708) published
in the December 31, 2014, Federal Register (79 FR 78954). The final
regulations provide guidance regarding the requirements for charitable
hospital organizations added by ACA. This document makes the following
corrections to 26 CFR parts 1 and 53:
PART 1--INCOME TAXES
Paragraph 1. The authority citation for part 1 continues to read in part as
follows:
Authority:
26 U.S.C. 7805 * * *
Par. 2. Section 1.501(r)-0 is amended by revising the heading for the table of
contents entry § 1.501(r)-7 to read as follows:
§ 1.501(r)-0 Outlines of regulations.
*****
§ 1.501(r)-7 Effective/applicability date.
*****
Par. 3. Section 1.501(r)-1 is amended by revising the first sentence of
paragraph (b)(23) and revising paragraph (b)(29)(ii)(B) to read as follows:
§ 1.501(r)-1 Definitions.
*****
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 39 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
(b) * * *
(23) Partnership agreement means, for purposes of paragraph
(b)(22)(ii)(B) of this section, all written agreements among the
partners, or between one or more partners and the partnership, and
concerning affairs of the partnership and responsibilities of the
partners, whether or not embodied in a document referred to by the
partners as the partnership agreement. * * *
*****
(29) * * *
(ii) * * *
(B) Without paying a fee to the hospitality facility, hospital
organization, or other entity maintaining the Web site; and
*****
Par. 4. Section 1.501(r)-2 is amended by revising the second sentence of
paragraph (c) to read as follows:
§ 1.501(r)-2 Failures to satisfy section 501(r).
*****
(c) * * * For purposes of this paragraph (c), a “willful” failure includes
a failure due to gross negligence, reckless disregard, or willful
neglect, and an “egregious” failure includes only a very serious
failure, taking into account the severity of the impact and the
number of affected persons. * * *
*****
Par. 5. Section 1.501(r)-3 is amended by revising the introductory text of
paragraph (c)(2) to read as follows:
§ 1.501(r)-3 Community health needs assessments.
*****
(c) * * *
(2) Description of how the hospital facility plans to address a
significant health need. A hospital facility's implementation strategy
will have described a plan to address a significant health need
identified through a CHNA for purposes of paragraph (c)(1)(i) of this
section if the implementation strategy—
*****
Par. 6. Section 1.501(r)-6 is amended by:
1. Revising paragraph (c)(4)(i)(A).
2. Revising the first sentence of paragraph (c)(4)(iii)(A).
3. Revising the second of paragraph (c)(4)(iv), Example 2.
4. Revising paragraph (c)(6)(i)(C)(1).
Roster key:
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 40 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
The revisions read as follows:
§ 1.501(r)-6 Billing and collection.
*****
(c) * * *
(4) * * *
(i) * * *
(A) Provides the individual with a written notice that indicates
financial assistance is available for eligible individuals, that identifies
the ECA(s) that the hospitality facility (or other authorized party)
intends to initiate to obtain payment for the care, and that states a
deadline after which such ECA(s) may be initiated that is no earlier
than 30 days after the date that the written notice is provided.
*****
(iii) * * *
(A) Otherwise meets the requirements of paragraph (c)(4)(i) of this
section but, instead of the notice described in paragraph (c)(4)(i)(A)
of this section, provides the individual with a FAP application form
and a written notice indicating that financial assistance is available
for eligible individuals and stating the deadline, if any, after which
the hospital facility will no longer accept and process a FAP
application submitted (or, if applicable, completed) by the individual
for the previously provided care at issue. * * *
*****
(iv) * * *
Example 2.
* * * Y also makes numerous attempts to encourage G to apply for
financial assistance, including by calling G to inform her about the
financial assistance available to eligible patients under Y's FAP and to
offer assistance with the FAP application process. * * *
*****
(6) * * *
(i) * * *
(C) * * *
(1) If the individual is determined to be eligible for assistance other
than free care, provides the individual with a billing statement that
indicates the amount the individual owes for the care as a FAPeligible individual and how that amount was determined and that
states, or describes how the individual can get information
regarding, the AGB for the care.
Roster key:
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 41 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
*****
Additional Requirements for Charitable
Hospitals
TD 9708
Additional Requirements for Charitable
Hospitals; Community Health Needs
Assessments for Charitable Hospitals;
Requirements of a Section 4959 Excise Tax
Return and Time for Filing the Return;
Correction
http://www.gpo.gov/fdsys/pkg/FR-2015-0311/pdf/2015-05520.pdf
Roster key:
Released:
3/11/2015
Due date:
None
PART 53--FOUNDATION AND SIMILAR EXCISE TAXES
Par. 8. The authority citation for part 53 continues to read in part as follows:
Authority:
26 U.S.C. 7805 * * *
Par. 9. In § 53.4959-1(c), the paragraph heading is revised to read as follows:
§ 53.4959-1 Taxes on failures by hospital organizations to meet section
501(r)(3).
*****
(c) Effective/applicability date.* * *
*****
This document contains corrections to final regulations (TD 9708) published
in the December 31, 2014, Federal Register (79 FR 78954). The final
regulations provide guidance regarding the requirements for charitable
hospital organizations added by ACA. As published, the final regulations
contain errors that might prove misleading and need clarification. This
document makes the following corrections:
1. On page 78961, first column, the eleventh line of the first full paragraph,
the language “only very serious failures, taking into” is corrected to read
“only a very serious failure, taking into”.
2. On page 78975, third column, the last line of the column, the language
“members of the hospital's community” is corrected to read “members
of the hospital facility's community”.
3. On page 78979, third column, the eighth line from the bottom the first
full paragraph, the language “co-payments, co-insurance, or” is corrected
to read “co-payments, co-insurance, and”.
4. On page 78980, the third column, the seventh line from the top of the
page, the language “form of co-payments, co-insurance, or” is corrected
to read “co-payments, co-insurance, and”.
5. On page 78981, the second column, the twenty-third line from the top of
the page, the language “payments, co-insurance, or deductibles),” is
corrected to read “payments, co-insurance, and deductibles),”.
6. On page 78982, the first column, the thirteenth line from the top of the
page, the language “obtain such percentages, a hospital” is corrected to
read “obtain such percentage(s), a hospital”.
7. On page 78983, the first column, the thirteenth line from the top of the
page, the language “required under section 501(r)(6)).” is corrected to
read “required by the regulations under section 501(r)(6)).”.
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 42 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
8.
9.
Medicare Quality Incentive Program
CMS-1614-CN
Released:
3/13/2015
Medicare Program; Quality Incentive
Program; Correction
Due date:
None
http://www.gpo.gov/fdsys/pkg/FR-2015-0313/pdf/2015-05766.pdf
Amendments to Excepted Benefits
TD 9714
DoL (RIN 1210-AB70)
CMS-9946-F2
Released:
3/18/2015
Due date:
None
On page 78983, the first column, the twelfth line from the bottom of the
first full paragraph, the language “facility must refund any amounts the”
is corrected to read “facility must refund any amount the”.
On page 78997, the first column, the heading “Adoption of Amendment
to the Regulation” is corrected to read “Adoption of Amendments to the
Regulation”.
This document corrects technical errors that appeared in the final rule
published in the November 6, 2014, Federal Register (79 FR 66120) and
titled “End-Stage Renal Disease Prospective Payment System, Quality
Incentive Program, and Durable Medical Equipment, Prosthetics, Orthotics,
and Supplies.” On page 66184 of the preamble, CMS has found errors in the
performance standard, achievement threshold, and benchmark values
presented in the Numerical Values for the Performance Standards for the
Payment Year (PY) 2017 End-Stage Renal Disease (ESRD) Quality Incentive
Program (QIP) Clinical Measures Using the Most Recently Available Data table
for PY 2017 of the ESRD QIP (Table 23). Specifically, CMS calculated the
numerical values published for the Standardized Readmission Ratio clinical
measure using only 6 months of data from calendar year 2013 instead of the
full 12 months, as specified under its finalized policy (79 FR 66183). This
technical correction ensures that these numerical standards align with the
finalized policies for the PY 2017 ESRD QIP.
This document contains final regulations that amend the regulations
regarding excepted benefits under ERISA, the Internal Revenue Code, and the
Public Health Service Act to specify requirements for limited wraparound
coverage to qualify as an excepted benefit. Excepted benefits generally are
exempt from the requirements added to those laws by HIPAA and ACA.
3/18/2015: Final rule. No
comments requested.
Under review.
Amendments to Excepted Benefits
http://www.gpo.gov/fdsys/pkg/FR-2015-0318/pdf/2015-06066.pdf
Revisions to Payment Policies Under the
Physician Fee Schedule, et al.
CMS-1612-F2
Medicare Program; Revisions to Payment
Policies Under the Physician Fee Schedule,
Clinical Laboratory Fee Schedule, Access to
Roster key:
Released:
3/20/2015
Due date:
None
This document corrects technical errors that appeared in the final rule with
comment period published in the November 13, 2014, Federal Register (79 FR
67547-68092) and titled “Medicare Program; Revisions to Payment Policies
under the Physician Fee Schedule, Clinical Laboratory Fee Schedule, Access to
Identifiable Data for the Center for Medicare and Medicaid Innovation
Models & Other Revisions to Part B for CY 2015.” This final rule took effect on
January 1, 2015.
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 43 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
Identifiable Data for the Center for Medicare
and Medicaid Innovation Models & Other
Revisions to Part B for CY 2015; Corrections
http://www.gpo.gov/fdsys/pkg/FR-2015-0320/pdf/2015-06427.pdf
Hardship Exemptions for Persons Meeting
Certain Criteria
CCIIO (no reference number)
Guidance on Hardship Exemptions for
Persons Meeting Certain Criteria
Released:
3/20/2015
Due date:
None
http://www.cms.gov/CCIIO/Resources/Regul
ations-and-Guidance/Downloads/HardshipExemption-Guidance-3-20-15-FINAL.pdf
Medicare Access and CHIP Reauthorization
Act of 2015
HR 2
Medicare Access and CHIP Reauthorization
Act of 2015
http://thomas.loc.gov/cgibin/query/z?c114:H.R.2:
Introduced:
3/24/2015
Due date:
None
This guidance provides information about (1) hardship exemption criteria
pertaining to enrollees in Children’s Health Insurance Program Buy-In
coverage and Elite Athlete Health Insurance, which are not classified as
minimum essential coverage (MEC), in use by Federally-Facilitated
Marketplaces (FFMs) (including State Partnership Marketplaces (SPMs)) and
possibly in use by State-based Marketplaces (SBMs) that process their own
exemptions; (2) hardship exemption criteria pertaining to individuals who
seek categorical Medicaid eligibility under section 1902(f) of the Social
Security Act (Act) for “209(b)” states in use by FFMs (including SPMs) and
possibly in use by SBMs; and (3) clarification of November 21, 2014, hardship
exemption guidance regarding consumers enrolled in Medicaid coverage not
classified as MEC provided to medically needy individuals under section
1902(a)(10)(C) of the Act.
This bill would amend title XVIII of the Social Security Act to repeal the
Medicare sustainable growth rate (SGR) and strengthen Medicare access by
improving physician payments and making other improvements, to
reauthorize CHIP, and for other purposes. A brief summary of each title of
this bill appears below.
Final. No comments
requested or
recommended.
3/26/2015: The House
passed this bill and sent it to
the Senate.
TITLE I--SGR REPEAL AND MEDICARE PROVIDER PAYMENT MODERNIZATION
This title would repeal SGR and provide a 5-year period of annual physician
payment updates of 0.5 percent to transition to a new system.
TITLE II--MEDICARE AND OTHER HEALTH EXTENDERS
This title would provide a number Medicare and other health “extenders,”
including section 213, which would extend special diabetes programs for
type 1 diabetes and for Indians through FY 2017.
TITLE III--THE CHILDREN’S HEALTH INSURANCE PROGRAM (CHIP)
This title would extend CHIP funding through FY 2017.
TITLE IV--OFFSETS
This title would establish several Medicare and other offsets, including
Roster key:
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 44 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
section 412, which would delay scheduled Medicaid disproportionate share
hospital (DSH) allotment reductions until FY 2018 and add another year of
reductions in FY 2025.
List of DME Items Requiring Face-to-Face
Encounter and Prior Written Order
CMS-6062-N
Medicare Program; Updates to the List of
Durable Medical Equipment (DME) Specified
Covered Items That Require a Face-to-Face
Encounter and a Written Order Prior to
Delivery
Released:
3/27/2015
Due date:
None
TITLE V--MISCELLANEOUS
This title includes the Protecting the Integrity of Medicare Act of 2015 (PIMA)
and several other provisions.
This notice updates the Healthcare Common Procedure Coding System
(HCPCS) codes on the Durable Medical Equipment (DME) List of Specified
Covered Items that require a face-to-face encounter and a written order prior
to delivery.
http://www.gpo.gov/fdsys/pkg/FR-2015-0327/pdf/2015-07108.pdf
CLIA Exemption for Labs in New York
CMS-3308-N
Released:
3/27/2015
Medicare, Medicaid, and CLIA Programs;
Clinical Laboratory Improvement
Amendments of 1988 Exemption of PermitHolding Laboratories in the State of New
York
Due date:
None
This notice announces that laboratories located in and licensed by the State
of New York with a valid permit under New York State Public Health Law
Article 5, Title V, are exempt from the requirements of the Clinical Laboratory
Improvement Amendments of 1988 (CLIA) for a period of 6 years.
http://www.gpo.gov/fdsys/pkg/FR-2015-0327/pdf/2015-07113.pdf
Establishment of the Multi-State Plan
Program for Exchanges
OPM (RIN 3206-AN12)
Patient Protection and Affordable Care Act;
Establishment of the Multi-State Plan
Program for the Affordable Insurance
Roster key:
Released:
3/30/2015
Due date:
None
This document corrects a final rule that appeared in the February 24, 2015,
Federal Register (80 FR 9649). The final rule implemented modifications to
the Multi-State Plan (MSP) Program based on the experience of the program
to date. This document makes the following corrections to the final rule:
1.
On page 9655, in the third column, the heading “List of Subjects in 5 CFR
part 800” is revised to read, “List of Subjects in 45 CFR part 800.”
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 45 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
Exchanges; Correction
2.
http://www.gpo.gov/fdsys/pkg/FR-2015-0330/pdf/2015-07330.pdf
ACA Implementation FAQs (Summary of
Benefits and Coverage)
CCIIO (no reference number)
Affordable Care Act Implementation FAQs
Released:
3/30/2015
Due date:
None
http://www.cms.gov/CCIIO/Resources/FactSheets-andFAQs/aca_implementation_faqs24.html
On page 9655, in the third column, the last paragraph should be revised
to read:
“Accordingly, the U.S. Office of Personnel Management is revising part
800 to title 45, Code of Federal Regulations, to read as follows:”
This guidance, prepared jointly by HHS and the Departments of Labor and the
Treasury (collectively, the Departments) answers an additional Frequently
Asked Question (FAQ) regarding implementation of ACA. In a December 2014
notice of proposed rulemaking, the Departments proposed changes to
summary of benefits and coverage (SBC) regulations, as well as a new SBC
template and associated documents. Changes to the SBC regulations,
template, and associated documents would apply beginning September 1,
2015. This guidance answers the question of when the Departments intend to
finalize changes to the regulations, SBC template, and associated documents.
According to this guidance:
“The Departments intend to finalize changes to the regulations in the near
future, which are intended to apply in connection with coverage that would
renew or begin on the first day of the first plan year (or, in the individual
market, policy year) that begins on or after January 1, 2016 (including open
season periods that occur in the Fall of 2015 for coverage beginning on or
after January 1, 2016).
4/1/2015: This document
provides additional
information on when and
how CMS will finalize the
templates for the revised
Summary of Benefits and
Coverage documents. This
includes the new
requirement for QHP issuers
to prepare SBCs for each of
the two Indian-specific costsharing variations.
The Departments also intend to utilize consumer testing and offer an
opportunity for the public, including the National Association of Insurance
Commissioners, to provide further input before finalizing revisions to the
SBC template and associated documents. The Departments anticipate the
new template and associated documents will be finalized by January 2016
and will apply to coverage that would renew or begin on the first day of the
first plan year (or, in the individual market, policy year) that begins on or after
January 1, 2017 (including open season periods that occur in the Fall of 2016
for coverage beginning on or after January 1, 2017).
Ending Special Enrollment Periods for
Coverage During CY 2014
CCIIO (no reference number)
Roster key:
Released:
3/31/2015
The Departments are fully committed to updating the template and
associated documents (including the uniform glossary) to better meet
consumers’ needs as quickly as possible.”
As of April 1, 2015, CMS will no longer accept new requests that would
enable consumers to enroll in a Qualified Health Plan (QHP) with 2014
coverage effective dates through the Federally-Facilitated or State
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 46 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
Ending Special Enrollment Periods for
Coverage during Calendar Year 2014
Due date:
None
http://www.cms.gov/CCIIO/Resources/Regul
ations-andGuidance/Downloads/Guidance_on_ending_
2014_SEPs.pdf
Q&A Regarding Rate Review Requirements
(Rounding Premiums)
CCIIO 2015-0001
Insurance Standards Bulletin Series:
Questions and Answers Regarding Rate
Review Requirements
http://www.cms.gov/CCIIO/Resources/Regul
ations-andGuidance/Downloads/RR_Guidance_on_Pre
mium_Rounding.pdf
Released:
3/31/2015
Due date:
None
Partnership Marketplaces through a Special Enrollment Period (SEP). As of
April 1, 2015, all SEP requests to CMS seeking 2014 coverage, with the
exception of SEPs issued as a result of an eligibility appeal described below, if
eligible for retroactive coverage, will receive a coverage effective date of
January 1, 2015.
This guidance applies to all SEPs specified in 45 CFR §155.420 and supersedes
all existing guidance on SEPs. This guidance does not apply to eligibility
appeal requests and does not impact the right of a consumer to request an
appeal of their eligibility determination in accordance with 45 CFR
§155.505(b).
This Bulletin provides guidance on when health insurance issuers can round
premium rates to the nearest dollar. Specifically, this guidance answers the
question of whether a state can allow issuers to round premiums for nongrandfathered single risk pool compliant plans in the individual or small group
(or merged) markets in their respective state to the nearest dollar. According
to this guidance:
“Yes. Premiums for non-grandfathered plans in the individual or small group
(or merged) markets generally are rounded to the nearest penny. However,
states enforcing the federal single risk pool and fair health insurance
premiums requirements under 45 CFR §§ 156.80 and 147.102 may allow
issuers to round premiums to the nearest dollar, as long as all of the following
conditions are met:


Roster key:
The premiums are based on unrounded rates, which are calculated
based on an index rate for the market and applicable plan level
adjustments and premium rating factors in compliance with the
single risk pool and fair health insurance premiums requirements
under 45 CFR §§ 156.80 and 147.102.
Premiums are rounded to the nearest dollar only based on
unrounded rates, plan level adjustments, and premium rating
factors. This means that premiums can only be rounded one time
and only after all of the permitted plan level adjustments and
applicable premium rating factors have been applied to the rate (i.e.,
after family size, geographic rating factor, age rating factor, and, if
applicable, tobacco rating factor are taken into account). Issuers may
not round rates at intermediate steps in the rate development
process.
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 47 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015


The practice of rounding premiums is done consistently across the
risk pool. If an issuer rounds premiums for one plan in the risk pool,
the issuer must round premiums for all plans in the risk pool.
Fractions of $0.50 or higher are rounded up to the nearest dollar and
fractions of less than $0.50 are rounded down to the nearest dollar.
If the rounded premium rates vary by more than 3:1 for like
individuals who are age 21 and older who vary in age, or by more
than 1.5:1 for like individuals who vary in tobacco use, the issuer
must adjust the rates to bring them into compliance with the 3:1 age
rating factor limit and the 1.5:1 tobacco rating factor limit.
In direct enforcement states, HHS enforces the single risk pool and fair health
insurance premiums provisions. In these states, issuers must continue to
round premiums to the nearest penny unless instructed otherwise in future
guidance.”
Medicare Secondary Payer and “Future
Medicals” (CMS-6047-P)
Received at
OMB:
8/1/2013
Influenza Vaccination Standard for Certain
Participating Providers and Suppliers (CMS3213-F)
Received at
OMB:
9/27/2013
CY 2015 Inpatient Hospital Deductible and
Hospital and Extended Care Services
Coinsurance Amounts (CMS-8056-N)
Received at
OMB:
9/18/2014
Roster key:
HEALTH-RELATED AGENCY ACTIONS PENDING AT OMB
This proposed rule would announce the intentions of CMS regarding means
beneficiaries or their representatives can use to protect Medicare with
respect to Medicare Secondary Payer (MSP) claims involving automobile and
liability insurance (including self-insurance), no-fault insurance, and workers’
compensation where future medical care is claimed or the settlement,
judgment, award, or other payment releases (or has the effect of releasing)
claims for future medical care.
Approved by OMB on 10/9/2014 but not yet released by the agency.
This final rule requires certain Medicare and Medicaid providers and
suppliers to offer all patients an annual influenza vaccination, unless
medically contraindicated or unless patients or their representative or
surrogate declined vaccination. This final rule seeks to increase the number
of patients receiving annual vaccination against seasonal influenza and to
decrease the morbidity and mortality rate from influenza. This final rule also
requires certain providers and suppliers to develop policies and procedures
that will allow them to offer vaccinations for pandemic influenza in case of a
future pandemic influenza event for which a vaccine might become available.
Approved by OMB on 4/18/2014 but not yet released by the agency.
This annual notice announces the inpatient hospital deductible and the
hospital and extended care service coinsurance amounts for services
furnished in calendar year 2015 under the Medicare Hospital Insurance
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 48 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
Program (Part A). The Medicare statute specifies the formula used to
determine these amounts.
CY 2015 Part A Premiums for the Uninsured
Aged and for Certain Disabled Individuals
Who Have Exhausted Other Entitlement
(CMS-8057-N)
CY 2015 Part B Monthly Actuarial Rates,
Monthly Premium Rates, and Annual
Deductible (CMS-8058-N)
Mental Health Parity and Addiction Equity
Act of 2008; the Application to Medicaid
Managed Care, CHIP, and Alternative Benefit
Plans (CMS-2333-P)
Received at
OMB:
9/18/2014
This annual notice announces the premiums for CY 2015 under the Medicare
Hospital Insurance Program (Part A) for the uninsured aged and for certain
disabled individuals who have exhausted other entitlement.
Received at
OMB:
9/18/2014
Received at
OMB:
1/7/2015
No detail provided.
Reimbursement Rates for Calendar Year
2015 (IHS RIN 0917-ZA29)
No detail provided.
FY 2016 Inpatient Psychiatric Facilities
Prospective Payment System--Rate Update
(CMS-1627-P)
Medicaid Managed Care, CHIP Delivered in
Managed Care, and Revisions Related to
Third Party Liability (CMS-2390-P)
Received at
OMB:
1/17/2015
Received at
OMB:
2/3/2015
Received at
OMB:
3/5/2015
Received at
OMB:
3/18/2015
Received at
OMB:
3/19/2015
FY 2016 Prospective Payment System and
Consolidated Billing for Skilled Nursing
Facilities (CMS-1622-P)
Electronic Health Record Incentive Program-Modifications to Meaningful Use in 2015
through 2017 (CMS-3311-P)
Received at
OMB:
3/20/2015
Received at
OMB:
3/24/2015
This annual proposed rule would update the payment rates used under the
prospective payment system for skilled nursing facilities for fiscal year 2016.
Pre-Existing Condition Insurance Plan
Program Updates (CMS-9995-IFC4)
Medicaid Mechanized Claims Processing and
Information Retrieval Systems (CMS-2392-P)
Roster key:
This proposed rule would address the requirements under the Paul
Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act
of 2008 (MHPAEA) to Medicaid Alternative Benefit Plans (ABPs), CHIP, and
Medicaid managed care organizations (MCOs).
Approved by OMB on 3/26/2015 but not yet released by the agency.
No detail provided.
No detail provided.
This annual proposed rule would update the prospective payment rates for
inpatient psychiatric facilities with discharges beginning on October 1, 2015.
This proposed rule would align Medicaid managed care regulations with
existing commercial, Marketplace, and Medicare Advantage regulations. This
rule also would implement certain Indian protections under section 5006 of
the American Recovery & Reinvestment Act.
3/20/2015: Once released, it
will be important to ensure
the AI/AN-specific
protections are adequate.
No detail provided.
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 49 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
DoL and IRS/Treasury
Health Insurance Premium Assistance Trust
Supporting the Purchase of Certain
Individual Health Insurance Policies-Exclusion from Definition of Employee
Welfare Benefit Plan (DoL RIN 1210-AB57)
OPM
None.
Received at
OMB:
8/24/2013
Summary of Benefits and Coverage and
Uniform Glossary
REG-145878-14
DoL (RIN 1210-AB69)
CMS-9938-P
Released:
12/22/2014
Summary of Benefits and Coverage and
Uniform Glossary
Due date:
3/2/2015
http://www.gpo.gov/fdsys/pkg/FR-2014-1230/pdf/2014-30243.pdf
Published:
12/30/2014
No detail provided.
RECENTLY SUBMITTED COMMENTS
This document contains proposed regulations regarding the summary of
benefits and coverage (SBC) and the uniform glossary for group health plans
and health insurance coverage in the group and individual markets under
ACA. It proposes changes to the regulations that implement the disclosure
requirements under section 2715 of the Public Health Service Act (PHS Act) to
help plans and individuals better understand their health coverage, as well as
to gain a better understanding of other coverage options for comparison. It
proposes changes to documents required for compliance with section 2715 of
the PHS Act, including a template for the SBC, instructions, sample language,
a guide for coverage example calculations, and the uniform glossary.
A CMS fact sheet on these proposed regulations is available at
http://www.cms.gov/CCIIO/Resources/Fact-Sheets-andFAQs/Downloads/SBC-Proposed-Rule-Fact-Sheet-122214.pdf
HHS also released a press release describing the proposed rule.
HHS Interg
Notification SBC 2014-12.pdf
Links to a number of proposed supporting materials related the SBC and
uniform glossary appear below:
Proposed SBC Blank Template:
http://www.cms.gov/CCIIO/Resources/Regulations-andGuidance/Downloads/blank-template-12-19-14-FINAL.pdf
Proposed Uniform Glossary:
http://www.cms.gov/CCIIO/Resources/Regulations-andGuidance/Downloads/Uniform-Glossary-12-19-14-FINAL.pdf
Roster key:
12/24/2014: These
proposed rules make
modifications to the content
of the Summary of Benefits
and Coverage.
Other recent proposed rules
pertaining to the Summary
of Benefits and Coverage
(SBC) documents were
contained in CMS-9944-P.
Tribal representatives
provided comments on
CMS-9944-P, which
mandates the release of SBC
by an issuer for each costsharing variation (including
the Indian-specific “zero”
and “limited” cost-sharing
variations).
There are no Indian-specific
provisions in this proposed
rule.
1/20/2015: Review of the
proposed rule in the
document below.
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 50 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
Proposed SBC Sample Completed Template:
http://www.cms.gov/CCIIO/Resources/Regulations-andGuidance/Downloads/Sample-completed-sbc-12-19-14-FINAL.pdf
Proposed Why This Matters language for SBC "No" Answers:
http://www.cms.gov/CCIIO/Resources/Regulations-andGuidance/Downloads/Why-This-Matters-No-Answers-FINAL.pdf
Proposed Why This Matters language for SBC "Yes" Answers:
http://www.cms.gov/CCIIO/Resources/Regulations-andGuidance/Downloads/Why-This-Matters-Yes-Answers-FINAL.pdf
CMS-9938-P
Summary of Benefits and Coverage 2015-01-2
See recommendations in
the attached and an
additional recommendation
in the column the left.
TTAG Comments on
CMS-9938-P.pdf
Proposed Instructions for Completing the SBC--Individual Health Insurance
Coverage: http://www.cms.gov/CCIIO/Resources/Regulations-andGuidance/Downloads/Instructions-Individual-12-19-14-FINAL.pdf
Proposed Instructions for Completing the SBC--Group Health Plan Coverage:
http://www.cms.gov/CCIIO/Resources/Regulations-andGuidance/Downloads/Instructions-Group-12-19-14-FINAL.pdf
Proposed Guide for Coverage Examples Calculations--Maternity Scenario:
http://www.cms.gov/CCIIO/Resources/Regulations-andGuidance/Downloads/Maternity-Scenario-MarketScan-Data-DRAFT-v4-NHE2.pdf
Proposed Coverage Examples Narrative--Maternity Scenario:
http://www.cms.gov/CCIIO/Resources/Regulations-andGuidance/Downloads/maternity-narrative.pdf
2/12/2015: Draft comments
prepared.
2/25/2015: Revised draft
comments attached below.
Draft TTAG
Comments on CMS-9938-P 2015-02-25d.docx
Proposed Guide for Coverage Examples Calculations--Diabetes Scenario:
http://www.cms.gov/CCIIO/Resources/Regulations-andGuidance/Downloads/Diabetes-Scenario-MarketScan-Data-DRAFT-v3NHE.PDF
Proposed Coverage Examples Narrative--Diabetes Scenario:
http://www.cms.gov/CCIIO/Resources/Regulations-andGuidance/Downloads/diabetes-narrative.pdf
Proposed Guide for Coverage Examples Calculations--Foot Fracture:
Roster key:
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 51 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
http://www.cms.gov/CCIIO/Resources/Regulations-andGuidance/Downloads/Foot-Fracture-Scenario-MarketScan-Data-DRAFT-v4NHE.PDF
Proposed Coverage Examples Narrative--Foot Fracture:
http://www.cms.gov/CCIIO/Resources/Regulations-andGuidance/Downloads/Coverage-Examples-narrative-foot-fracture.pdf
ANALYSIS AND RECOMMENDATION:
Analysis: Please see document imbedded in the right column.
Recommendations: Tribal organizations did previously submit
recommendations –and CMS agreed– on the need for an SBC for each of the
Indian-specific cost-sharing variations that a plan is required to offer (limited
cost-sharing variation and zero cost-sharing variation). One comment on this
Proposed Rule that tribal representatives may wish to submit is that (a) we
continue to support the addition of the requirement (as proposed in CMS9944-P) for issuers to prepare and make available SBCs for each Indianspecific cost-sharing variation; (b) modifications to the SBC template may be
needed as issuers work to incorporate the required plan information into
SBCs for the Indian-specific cost-sharing variations; (c) tribal representatives
encourage CMS to review the SBCs that are prepared by issuers for the
Indian-specific cost-sharing variations and engage with tribal representatives
to determine if modifications to the SBC template are needed; and
ADDITIONAL RECOMMENDATION: (d) tribal representatives recommend
that CMS provide sample language—for use by QHP issuers in the
preparation of the SBCs—to describe how the “zero” and “limited” costsharing variations impact deductibles, co-insurance, etc., for in-network and
out-of-network providers. There has been confusion on the part of some
issuers on the fact that the Indian-specific cost-sharing protections apply
uniformly to in-network and out-of-network providers, except for the issue of
balance billing.
Comments submitted:
TTAG Comments on
CMS-9938-P.pdf
Roster key:
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 52 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
Solicitation of New Safe Harbors and
Special Fraud Alerts
OIG-123-N
Solicitation of New Safe Harbors and Special
Fraud Alerts
Released:
12/30/2014
Due date:
3/2/2015
In accordance with section 205 of HIPAA, this annual notice solicits
proposals and recommendations for developing new and modifying existing
safe harbor provisions under the Federal anti-kickback statute (section
1128B(b) of the Social Security Act), as well as developing new HHS OIG
Special Fraud Alerts.
12/30/2014: This request
for comments provides
another opportunity to
tribal representatives to
make a case for I/T/Uspecific safe harbors.
Comments submitted:
http://www.gpo.gov/fdsys/pkg/FR-2014-1230/pdf/2014-30156.pdf
TTAG Comments on
OIG-123-N.pdf
Expanded Access to Non-VA Care Through
Veterans Choice Program
VA (RIN 2900-AP24)
Expanded Access to Non-VA Care Through
the Veterans Choice Program
http://www.gpo.gov/fdsys/pkg/FR-2014-1105/pdf/2014-26316.pdf
http://www.gpo.gov/fdsys/pkg/FR-2014-1121/pdf/2014-27581.pdf
Released:
11/5/2014
Due date:
3/5/2015
VA amends its medical regulations concerning its authority for eligible
veterans to receive care from non-VA entities and providers. The Veterans
Access, Choice, and Accountability Act of 2014 directs VA to establish a
program to furnish hospital care and medical services through non-VA health
care providers to veterans who either cannot receive care within the waittime goals of the Veterans Health Administration or who qualify based on
their place of residence (the Veterans Choice Program, or the “Program”).
The law also requires VA to publish an interim final rule establishing this
program. This interim final rule defines the parameters of the Veterans
Choice Program and clarifies aspects affecting veterans and the non-VA
providers that will furnish hospital care and medical services through the
Veterans Choice Program.
Analysis: Under “eligible entities and providers”, the following definition is
provided” “Section 17.1530 defines requirements for non-VA entities and
health care providers to be eligible to be reimbursed for furnishing hospital
care and medical services to eligible veterans under the Program. Paragraph
(a) of this section provides that an entity or provider must be accessible to
the veteran and be one of the four entities specified in section 101(a)(1)(B) of
the Act. These include any health care provider that is participating in the
Medicare program under title XVIII of the Social Security Act (42 U.S.C. 1395
et seq.), including any physician furnishing services under such program; any
Federally-qualified health center (as defined in section 1905(l)(2)(B)
of the Social Security Act (42 U.S.C. 1396d(l)(2)(B)); the Department of
Defense; or the Indian Health Service. Outpatient health programs or
facilities operated by a tribe or tribal organization under the Indian Self-
Roster key:
1/21/2014: Myra and Elliott
may re-draft and resubmit
previously submitted recs.
Possibly ask OIG attend
TTAG meeting.
11/6/2014: This interim
final rule was issued by the
VA to implement the new
private care option
authorized by Congress.
11/12: Sam to review with
Myra on eligibility criteria to
confirm all I/T/Us are
included.
1/20/2015: Comments
submitted by TSGAC on a
related VA request for tribal
consultation show below:
TSGAC Comments VA
Agreements dated 1-14-15.pdf
1/21/2015: Myra to
prepare first draft of
comments.
3/5/2015: NIHB filed
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 53 of 54
2015-04-01
Roster of Pending Health-related Federal Regulations
– as of 4/1/2015
Determination and Education Assistance Act or by an urban Indian
organization receiving funds under title V of the Indian Health Care
Improvement Act are defined as Federally-qualified health centers in
section 1905(l)(2)(B) of the Social Security Act and would be eligible
providers under section 101(a)(1)(B).”
comments.
NIHB Comments on
VA CHOICE.pdf
Under this definition, I/T/U are included as eligible providers either as being a
Medicare participating provider or as an FQHC under SSA 42 U.S.C.
1396d(l)(2)(B).
Notice of start date (11/21/2014): In the interim final rule, VA established
start dates for participation in the Veterans Choice Program (the
“Program”) for different groups of veterans depending upon their basis of
eligibility to participate. In those regulations, VA stated that veterans
eligible based upon their inability to schedule an appointment within the
wait-time goals of the Veterans Health Administration can start receiving
hospital care and medical services under the Program no later than
December 5, 2014. VA also stated that, if these veterans had a start date
earlier than December 5, 2014, VA would publish a notice in the Federal
Register advising the public of the faster implementation schedule. This
notice announces that November 17, 2014, serves as the start date for
veterans eligible to participate in the Program.
Roster key:
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 54 of 54
2015-04-01
Download