Roster of Pending Health-related Federal Regulations
– as of 2/11/2015
Lead Agency: SHORT TITLE
Reference Number; Title of Reg/Agency
Action
Survey of Retail Prices
CMS-10241
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2014-1219/pdf/2014-29741.pdf
External Quality Review of Medicaid
Managed Care Organizations
CMS-R-305
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2014-1219/pdf/2014-29741.pdf
Federally Qualified Health Center Cost
Report Form
CMS-224-14
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2014-1219/pdf/2014-29741.pdf
Roster key:
Agency release
date; due date
Agency’s Summary of Action
for comments
Released:
1. Type of Information Collection Request: Extension of a currently approved
12/19/2014
collection; Title: Survey of Retail Prices: Payment and Utilization Rates and
Performance Rankings; Use: This study has two parts. Part I focuses on the
Due date:
retail community pharmacy consumer prices. It also includes reporting by the
2/17/2015
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. (Effective July 1, 2013, CMS has suspended Part I of the survey,
pending funding decisions.) 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.
Released:
2. Type of Information Collection Request: Extension of a currently approved
12/19/2014
collection; Title: External Quality Review (EQR) of Medicaid Managed Care
Organizations (MCOs) and Supporting Regulations; Use: State agencies must
Due date:
provide to the EQR organization (EQRO) information obtained through
2/17/2015
methods consistent with the protocols specified by CMS. The EQRO uses this
information to determine the quality of care furnished by an MCO. In
addition, Medicaid/CHIP enrollees and potential enrollees use this
information to make informed choices regarding the selection of their
providers. It also allows advocacy organizations, researchers, and other
interested parties access to information on the quality of care provided to
Medicaid beneficiaries enrolled in Medicaid/CHIP MCOs. States use this
information during their oversight of these organizations.
Released:
12/19/2014
Due date:
2/17/2015
3. Type of Information Collection Request: New collection; Title: Federally
Qualified Health Center Cost Report Form; 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), 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 requires the CMS-224-14 cost report to determine
reasonable costs incurred by a provider in furnishing medical services to
Medicare beneficiaries and reimbursement due to or from a provider.
Notes:
12/19/2014: Paperwork
Reduction Act notice.
12/19/2014: Paperwork
Reduction Act notice.
Forwarded to Data Team for
review.
12/19/2014: 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 1 of 43
2015-02-11
Roster of Pending Health-related Federal Regulations
– as of 2/11/2015
National Provider Identifier Application and
Update Form
CMS-10114
PRA Request for Comment
Released:
1/16/2015
Due date:
2/17/2015
http://www.gpo.gov/fdsys/pkg/FR-2015-0116/pdf/2015-00626.pdf
Rural Health Care Services Outreach
Program Measures
HRSA (OMB 0915-xxxx)
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2014-1222/pdf/2014-29837.pdf
Released:
12/22/2014
Due date:
2/20/2015
Type of Information Collection Request: Extension of a currently approved
collection; Title: National Provider Identifier (NPI) Application and Update
Form and Supporting Regulations in 45 CFR 142.408, 45 CFR 162.406, 45 CFR
162.408; Use: Health care providers use the National Provider Identifier (NPI)
Application and Update Form to apply for NPIs and furnish updates to the
information they supplied on their initial applications, as well as to deactivate
their NPIs if necessary. CMS has revised the NPI Application/Update form to
provide additional guidance on how to accurately complete the form. This
collection includes clarification on information required on
applications/changes. Minor changes on the NPI Application/Update form
include adding a “Subpart” check box in the Other Name section and a
revision within the PRA Disclosure Statement. This collection also includes
changes to the instructions.
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.
12/19/2014: Paperwork
Reduction Act notice.
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.
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 2 of 43
2015-02-11
Roster of Pending Health-related Federal Regulations
– as of 2/11/2015
Rural Health Network Development
Program
HRSA (OMB 0915-xxxx)
PRA Request for Comment
Released:
12/22/2014
Due date:
2/20/2015
http://www.gpo.gov/fdsys/pkg/FR-2014-1222/pdf/2014-29772.pdf
Survey Report Form for Clinical Laboratory
Improvement Amendments
CMS-1557
PRA Request for Comment
Released:
12/24/2014
Due date:
2/23/2015
http://www.gpo.gov/fdsys/pkg/FR-2014-1224/pdf/2014-30027.pdf
Prior Authorization Form for Beneficiaries
Enrolled in Hospice
CMS-10538
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2015-0123/pdf/2015-01127.pdf
Roster key:
Released:
1/23/2014
Due date:
2/23/2015
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.
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.
Type of Information Collection Request: Extension of a currently approved
collection; Title: Survey Report Form for Clinical Laboratory Improvement
Amendments (CLIA) and Supporting Regulations; Use: Surveyors use the form
to report findings during a CLIA survey. For each type of survey conducted
(i.e., initial certification, recertification, validation, complaint,
addition/deletion of specialty/subspecialty, transfusion fatality investigation,
or revisit inspections) the Survey Report Form incorporates the requirements
specified in the CLIA regulations.
12/19/2014: Paperwork
Reduction Act notice.
12/19/2014: Paperwork
Reduction Act notice.
1. Type of Information Collection Request: New collection; Title: Prior
Authorization Form for Beneficiaries Enrolled in Hospice; Use: The prescriber
or hospice of the beneficiary would complete this form, or if the prescriber or
hospice provides the information verbally to the Part D sponsor, the sponsor
would complete it. The Part D sponsor would use the Information provided
on the form to establish coverage of the drug under Medicare Part D. Per
statute, drugs necessary for the palliation and management of the terminal
illness and related conditions do not qualify for payment under Part D. The
standard form provides a vehicle for the hospice, prescriber, or sponsor to
document that the drug prescribed is “unrelated” to the terminal illness and
related conditions. It also gives a hospice the option to communicate any
change in the hospice status and care plan of a beneficiary to the Part D
sponsor. CMS has revised this package subsequent to the publication of the
60-day notice in October 3, 2014, Federal Register (79 FR 59772).
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 43
2015-02-11
Roster of Pending Health-related Federal Regulations
– as of 2/11/2015
Annual Eligibility Redetermination, Product
Discontinuation, and Renewal Notices
CMS-10527
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2015-0123/pdf/2015-01127.pdf
Released:
1/23/2014
Due date:
2/23/2015
2. Type of Information Collection Request: Extension of a currently approved
collection; Title: Annual Eligibility Redetermination, Product Discontinuation,
and Renewal Notices; Use: Section 1411(f)(1)(B) of ACA directs the HHS
Secretary to establish procedures to redetermine the eligibility of individuals
on a periodic basis in appropriate circumstances. Section 1321(a) of ACA
provides authority for the HHS Secretary to establish standards and
regulations to implement the statutory requirements related to Exchanges,
Qualified Health Plans (QHPs), and other components of title I of ACA. Under
section 2703 of the Public Health Service Act (PHS Act), as added by ACA, and
sections 2712 and 2741 of the PHS Act, enacted by HIPAA, health insurance
issuers in the group and individual markets must guarantee the renewability
of coverage unless an exception applies.
1/23/2015: Paperwork
Reduction Act notice. No
comments recommended.
The final rule “Patient Protection and Affordable Care Act; Annual Eligibility
Redeterminations for Exchange Participation and Insurance Affordability
Programs; Health Insurance Issuer Standards Under the Affordable Care Act,
Including Standards Related to Exchanges” (79 FR 52994) provides that an
Exchange can choose to conduct the annual redetermination process for a
plan year (1) in accordance with the existing procedures described in 45 CFR
155.335; (2) in accordance with procedures described in guidance issued by
the Secretary for the coverage year; or (3) using an alternative proposed by
the Exchange and approved by the HHS Secretary. The guidance document
“Guidance on Annual Redeterminations for Coverage for 2015” contains the
procedures that the Secretary has specified for the 2015 coverage year, as
noted in (2) above. These procedures will apply to the Federally-Facilitated
Exchange. Under this option, the Exchange will provide three notices, which
the Exchange can combine.
The final rule also amends the requirements for product renewal and reenrollment (or non-renewal) notices sent by QHP issuers in the Exchanges
and specifies content for these notices. The accompanying guidance
document “Form and Manner of Notices When Discontinuing or Renewing a
Product in the Group or Individual Market” provides standard notices for
product discontinuation and renewal sent by issuers of individual market
QHPs and issuers in the individual market. Issuers in the small group market
can use the draft Federal standard small group notices released in the June
26, 2014, bulletin “Draft Standard Notices When Discontinuing or Renewing a
Product in the Small Group or Individual Market” or any forms of the notice
otherwise permitted by applicable laws and regulations. States enforcing ACA
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 43
2015-02-11
Roster of Pending Health-related Federal Regulations
– as of 2/11/2015
Safe Harbor for Federally Qualified Health
Centers Arrangements
HHS-OS-0990-0322-30D
PRA Request for Comment
Released:
1/23/2014
Due date:
2/23/2015
http://www.gpo.gov/fdsys/pkg/FR-2015-0123/pdf/2015-01098.pdf
Permanent Certification Program for HIT
HHS-0955-0013-30D
Released:
1/23/2014
PRA Request for Comment
Due date:
2/23/2015
http://www.gpo.gov/fdsys/pkg/FR-2015-0123/pdf/2015-01103.pdf
Loan Repayment Program for Repayment of
Health Professions
IHS (no reference number)
Loan Repayment Program for Repayment of
Health Professions Educational Loans
Announcement Type: Initial
http://www.gpo.gov/fdsys/pkg/FR-2015-02Roster key:
Released: 2/2/2015
Due date:
2/13/2015;
8/14/2015;
9/11/2015;
9/30/2015
can develop their own standard notices for product discontinuances,
renewals, or both, provided the State-developed notices provide at least the
same level of protection as the Federal standard notices.
Type of Information Collection Request: Reinstatement of a previously
approved collection; Title: Safe Harbor for Federally Qualified Health Centers
Arrangements; Use: HHS OIG seeks OMB approval of a reinstatement without
change for data collection 0990-0322, requirements associated with a
voluntary safe harbor for Federally Qualified Health Centers under the
Federal anti-kickback statute. See 72 FR 56632 (October 4, 2007). The safe
harbor protects certain arrangements involving goods, items, services,
donations, and loans provided by individuals and entities to certain health
centers funded under section 330 of the Public Health Service Act.
Type of Information Collection Request: Reinstatement of a previously
approved collection; Title: Permanent Certification Program for Health
Information Technology; Use: The HHS Office of the National Coordinator for
Health Information Technology ONC) seeks OMB approval of a reinstatement
without change to a previously approved collection of information under the
permanent certification program (OMB 0990-0013). Under 45 CFR 170.523(f),
ONC-Authorized Certification Bodies (ONC-ACBs) must provide ONC, no less
frequently than weekly, a current list of Complete EHRs and/or certified EHR
Modules. The list must include, at a minimum, the vendor name (if
applicable), the date certified, the product version, the unique certification
number or other specific product identification, and where applicable, the
certification criterion or certification criteria to which each EHR Module has
received certification. Organizations that wish to become ONC-ACBs must
submit the information specified by the application requirements, and ONCACBs must comply with collection, reporting, and records retention
requirements, as well as submit annual surveillance plans and annually report
surveillance results.
The IHS estimated budget request for Fiscal Year (FY) 2015 includes
$16,721,135 for the IHS Loan Repayment Program (LRP) for health
professional educational loans (undergraduate and graduate) in return for
full-time clinical service as defined in the IHS LRP policy clarifications at
http://www.ihs.gov/loanrepayment/documents/LRP_Policy_Updates.pdf in
Indian health programs.
IHS has published this program announcement early to coincide with its
recruitment activity, as the agency competes with other Government and
1/23/2015: Paperwork
Reduction Act notice.
Implementation of a
previously approved safe
harbor. No comments
recommended.
1/23/2015: Paperwork
Reduction Act notice.
Requirement applies to ONC
certification bodies. No
comments recommended.
CFDA number: 93.164
Key dates:
--First award cycle deadline:
2/13/2015
--Last award cycle deadline:
8/14/2015
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 5 of 43
2015-02-11
Roster of Pending Health-related Federal Regulations
– as of 2/11/2015
02/pdf/2015-01958.pdf
private health management organizations to employ qualified health
professionals.
The Indian Health Care Improvement Act (IHCIA) Section 108, codified at 25
U.S.C. 1616a, authorizes this program.
Indian Health Professions Scholarship
Programs
IHS (no reference number)
Indian Health Professions Preparatory,
Indian Health Professions Pre-Graduate and
Indian Health Professions Scholarship
Programs Announcement Type: Initial
Released:
12/22/2014
Due date:
2/28/2015;
3/28/2015
IHS seeks to encourage AI/ANs to enter the health professions and to assure
the availability of Indian health professionals to serve Indians. IHS seeks to
recruit students for the following programs:
CFDA numbers: 93.971,
93.123, and 93.972
1.
Key dates:
2.
3.
http://www.gpo.gov/fdsys/pkg/FR-2014-1222/pdf/2014-29432.pdf
The Indian Health Professions Preparatory Scholarship, authorized by
Section 103 of the Indian Health Care Improvement Act (IHCIA);
The Indian Health Professions Pre-graduate Scholarship authorized by
Section 103 of IHCIA; and
The Indian Health Professions Scholarship, authorized by Section 104 of
the IHCIA.
IHS will fund full-time and part-time scholarships for each of the three
scholarship programs. The scholarship award selections and funding remain
subject to availability of funds appropriated for the Scholarship Program.
Requirements and Registration for ‘‘Market
R&D Pilot Challenge’’
HHS ONC (no reference number)
Announcement of Requirements and
Registration for ‘‘Market R&D Pilot
Challenge’’
http://www.gpo.gov/fdsys/pkg/FR-2014-1021/pdf/2014-24918.pdf
Roster key:
Released:
10/21/2014
Due date:
3/2/2015
-- Last award cycle deadline
for supplemental loan
repayment program funds:
9/11/2015
--Entry on duty deadline:
9/30/2015
Developers and innovators have many great ideas and products that could
improve the U.S. health care system and make life better for patients and
providers. However, effecting actual change is extremely difficult due to the
high barriers to entry in the health IT space.
The Market R&D Pilot Challenge seeks to help bridge this gap by bringing
together health care organizations (“Hosts”) and innovative companies
(“Innovators”) through pilot funding awards and facilitated matchmaking. The
Challenge seeks to award pilot proposals in three different domains: Clinical
environments (e.g., hospitals, ambulatory care, surgical centers), public
health and community environments (community-based personnel, such as
--Application deadline:
2/28/2015, for continuing
students
--Application deadline:
3/28/2015, for new
students
--Application review: 5/115/22/2015
--Continuation award
notification deadline:
6/5/2015
--New award notification
deadline: 7/2/2015
--Award start: 8/1/2015
--Acceptance/decline of
awards deadline: 8/14/2015
Key dates:
--Challenge launch:
10/20/2014
--Matchmaking events: Early
December 2014 to midJanuary 2015
--Submissions due: 3/2/2015
--Winners announced:
4/30/2015
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 6 of 43
2015-02-11
Roster of Pending Health-related Federal Regulations
– as of 2/11/2015
public health departments, community health workers, mobile medical
trucks, school- and jail-based clinics), and consumer health (e.g., self-insured
employers, pharmacies, laboratories). Hosts and Innovators will submit joint
pilot proposals, with the winners, as determined by an expert panel,
proceeding to implement their pilots.
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
The statutory authority for this challenge competition appears in Section 105
of the America COMPETES Reauthorization Act of 2010.
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
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 7 of 43
2015-02-11
Roster of Pending Health-related Federal Regulations
– as of 2/11/2015
Proposed Uniform Glossary:
http://www.cms.gov/CCIIO/Resources/Regulations-andGuidance/Downloads/Uniform-Glossary-12-19-14-FINAL.pdf
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
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
Proposed Guide for Coverage Examples Calculations--Diabetes Scenario:
http://www.cms.gov/CCIIO/Resources/Regulations-andGuidance/Downloads/Diabetes-Scenario-MarketScan-Data-DRAFT-v3NHE.PDF
Roster key:
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.
2/4/2015: After reviewing
the linked documents, the
following additional
recommendation is
suggested for consideration:
(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 Indianspecific cost-sharing
protections apply uniformly
to in-network and out-ofnetwork providers, except
for the issue of balance
billing.
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 43
2015-02-11
Roster of Pending Health-related Federal Regulations
– as of 2/11/2015
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:
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.
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 9 of 43
2015-02-11
Roster of Pending Health-related Federal Regulations
– as of 2/11/2015
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.
http://www.gpo.gov/fdsys/pkg/FR-2014-1230/pdf/2014-30156.pdf
Ambulatory Surgical Center Quality
Reporting Program
CMS-10530
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2015-0130/pdf/2015-01777.pdf
12/30/2014: This request
for comments provides
another opportunity to
tribal representatives to
make a case for I/T/Uspecific safe harbors.
1/21/2014: Myra and Elliott
may re-draft and resubmit
previously submitted recs.
Possibly ask OIG attend
TTAG meeting.
Released:
1/30/2015
Due date:
3/2/2015
1. Type of Information Collection Request: New collection; Title: Ambulatory
Surgical Center Quality Reporting Program; Use: CMS quality reporting
programs promote higher quality, more efficient health care for Medicare
beneficiaries. CMS has implemented quality measure reporting programs for
multiple settings, including for ambulatory surgical centers (ASCs). Section
109(b) of the Tax Relief and Health Care Act of 2006 (TRHCA) amended
section 1833(i) of the Social Security Act (the Act) by re-designating clause (iv)
as clause (v) and adding new clause (iv) to paragraph (2)(D) and by adding
new paragraph (7). Section 1833(i)(2)(D)(iv) of the Act authorizes, but does
not require, the HHS Secretary to implement the revised ASC payment system
“in a manner so as to provide for a reduction in any annual update for failure
to report on quality measures in accordance with paragraph (7).” Section
1833(i)(7)(A) of the Act states that the HHS Secretary can provide that any
ASC failing to submit quality measures in accordance with paragraph (7) will
incur a 2.0 percentage point reduction to any annual increase provided under
the revised ASC payment system for such year. Sections 1833(t)(17)(C)(i) and
(ii) of the Act require the HHS Secretary to develop measures appropriate for
the measurement of the quality of care furnished in outpatient settings.
1/31/2015: Paperwork
Reduction Act notice.
No comments
recommended.
Section 3014 of ACA modified section 1890(b) of the Act to require CMS to
develop quality and efficiency measures through a “consensus-based entity.”
To fulfill this requirement, CMS formed the Measure Applications Partnership
(MAP) to review measures consistent with these requirements. In
implementing this and other quality reporting programs, CMS seeks to
support National Quality Strategy goals of better health for individuals, better
health for populations, and lower costs for health 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 10 of 43
2015-02-11
Roster of Pending Health-related Federal Regulations
– as of 2/11/2015
Certification as a Portable X-Ray Supplier
and Portable X-Ray Survey Report Form
CMS-1880 and CMS-1882
PRA Request for Comment
Released:
1/30/2015
Due date:
3/2/2015
http://www.gpo.gov/fdsys/pkg/FR-2015-0130/pdf/2015-01777.pdf
CMS uses this information to direct contractors, including Quality
Improvement Organizations (QIOs), to focus on particular areas of
improvement and to develop quality improvement initiatives. CMS makes this
information available to ASCs for their use in internal quality improvement
initiatives. Most importantly, Medicare beneficiaries, as well as to the general
public, can use this information to assist them in making decisions about their
health care.
2. Type of Information Collection Request: Extension without change of a
currently approved collection; Title: Certification as a Supplier of Portable XRay and Portable X-Ray Survey Report Form and Supporting Regulations; Use:
Suppliers of portable X-ray services expressing an interest in and requesting
participation in the Medicare program initially complete CMS-1880. This form
initiates the process of obtaining a decision as to whether they meet the
conditions of coverage as a portable X-ray supplier. It also promotes data
reduction or introduction to, and retrieval from, the Certification and Survey
Provider Enhanced Reporting (CASPER) by the CMS Regional Offices (ROs).
1/31/2015: Paperwork
Reduction Act notice.
No comments
recommended.
The State survey agency uses CMS-1882 to provide data collected during an
onsite survey of a supplier of portable X-ray services to determine compliance
with the applicable conditions of participation and to report this information
to the Federal Government. The form primarily serves as a coding worksheet
designed to facilitate data reduction and retrieval into the ASPEN system at
the CMS Regional Offices. The form includes basic information on compliance
(i.e., met, not met, explanatory statements) and does not require any
descriptive information regarding the survey activity itself. CMS has the
responsibility and authority for certification decisions based on supplier
compliance with the applicable conditions of participation. CMS has access to
the information needed to make these decisions only through the use of
information abstracted from the survey report form.
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-2014-11Roster key:
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
11/6/2014: This interim
final rule was issued by the
VA to implement the new
private care option
authorized by Congress.
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 43
2015-02-11
Roster of Pending Health-related Federal Regulations
– as of 2/11/2015
05/pdf/2014-26316.pdf
http://www.gpo.gov/fdsys/pkg/FR-2014-1121/pdf/2014-27581.pdf
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.
11/12: Sam to review with
Myra on eligibility criteria to
confirm all I/T/Us are
included.
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 SelfDetermination 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).”
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.
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
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 12 of 43
2015-02-11
Roster of Pending Health-related Federal Regulations
– as of 2/11/2015
veterans eligible to participate in the Program.
FEHBP: Rate Setting for Community-Rated
Plans
OPM (RIN 3206-AN00)
Federal Employees Health Benefits Program;
Rate Setting for Community-Rated Plans
Released:
1/7/2015
Due date:
3/9/2015
http://www.gpo.gov/fdsys/pkg/FR-2015-0107/pdf/2014-30633.pdf
Medicare and Medicaid OASIS Collection
Requirements as Part of the CoPs for HHAs
CMS-R-245
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2015-0206/pdf/2015-02413.pdf
Released:
2/6/2015
Due date:
3/9/2015
This proposed rule would make changes to the Federal Employees Health
Benefits Acquisition Regulation (FEHBAR). These changes would: Define
which subscriber groups might qualify as similarly sized subscriber groups
(SSSGs); require SSSGs to use a traditional community rating; establish that
traditional community-rated Federal Employees Health Benefits Program
(FEHBP) plans must select only one, rather than two, SSSGs; and make
conforming changes to FEHBP contract language to account for the new
medical loss ratio (MLR) standard for most community-rated FEHBP plans.
Type of Information Collection Request: Extension of a currently approved
collection; Title: Medicare and Medicaid Programs OASIS Collection
Requirements as Part of the CoPs for HHAs and Supporting Regulations; Use:
Home Health Agencies (HHAs) must use the Outcome and Assessment
Information Set (OASIS) data set as a condition of participation (CoP) in the
Medicare program. Since 1999, the Medicare CoPs have mandated that HHAs
use the OASIS data set when evaluating adult non-maternity patients
receiving skilled services.
OMB approved the OASIS-C1 information collection request on February 6,
2014. CMS originally planned to use OASIS-C1 to coincide with the original
implementation of ICD-10 on October 1, 2014. However, the Protecting
Access to Medicare Act of 2014 (PAMA), enacted on April 1, 2014, prohibits
CMS from adopting ICD-10 coding prior to October 1, 2015. Because OASIS-C1
relies on ICD-10 coding, implementation of OASIS-C1 cannot occur prior to
October 1, 2015. The passage of the PAMA Act left CMS with the dilemma of
how to collect OASIS data in the interim, until implementation of ICD-10.
CMS developed the OASIS-C1/ICD-9 version, an interim version of the OASISC1 data item set, in response to the legislatively mandated ICD-10 delay. Five
items in OASIS-C1 require ICD-10 codes. In the OASIS-C1/ICD-9 version, CMS
replaced these items with the corresponding items from OASIS-C that use
ICD-9 coding. The OASIS-C1/ICD-9 version also incorporates updated clinical
concepts, modified item wording and response categories, and improved
item clarity. In addition, the OASIS-C1/ICD-9 version includes a significant
decrease in provider burden through the deletion of a number of nonessential data items from the OASIS-C data item set.
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 43
2015-02-11
Roster of Pending Health-related Federal Regulations
– as of 2/11/2015
Administrative Requirements for DRA
Section 6071
CMS-10249
PRA Request for Comment
Released:
1/9/2015
Due date:
3/10/2015
http://www.gpo.gov/fdsys/pkg/FR-2015-0109/pdf/2015-00175.pdf
Outcome and Assessment Information Set-OASIS-C1/ICD-10
CMS-10545
PRA Request for Comment
Released:
1/9/2015
Due date:
3/10/2015
http://www.gpo.gov/fdsys/pkg/FR-2015-0109/pdf/2015-00175.pdf
National Practitioner Data Bank for Adverse
Information on Physicians
HRSA (OMB 0915-0126)
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2015-0210/pdf/2015-02658.pdf
Roster key:
Released:
2/10/2014
Due date:
3/12/2015
1. 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.
2. 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.
Type of Information Collection Request: Revision of a currently approved
collection; Title: National Practitioner Data Bank for Adverse Information on
Physicians and Other Health Care Practitioners; Use: This request seeks a
revision of OMB approval of the information collection contained in
regulations found at 45 CFR part 60 governing the National Practitioner Data
Bank (NPDB) and the forms used in registering with, reporting information to,
and requesting information from NPDB. This request also includes
administrative forms to aid in monitoring compliance with federal reporting
and querying requirements. Responsibility for NPDB implementation and
operation resides in the HRSA Bureau of Health Workforce.
2/10/2015: 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 14 of 43
2015-02-11
Roster of Pending Health-related Federal Regulations
– as of 2/11/2015
The reporting forms, request for information forms (query forms), and
administrative forms (used to monitor compliance) are accessed, completed,
and submitted to NPDB electronically through the NPDB Web site at
http://www.npdb.hrsa.gov/. All reporting and querying occurs through this
secure Web site.
Annual Report on Home and Community
Based Services Waivers
CMS-372(S)
PRA Request for Comment
Released:
1/16/2015
Due date:
3/17/2015
http://www.gpo.gov/fdsys/pkg/FR-2015-0116/pdf/2015-00627.pdf
Outpatient/Ambulatory Surgery Patient
Experience of Care Survey
CMS-10500
PRA Request for Comment
Released:
1/16/2015
Due date:
3/17/2015
http://www.gpo.gov/fdsys/pkg/FR-2015-0116/pdf/2015-00627.pdf
Site Investigation for Independent
Diagnostic Testing Facilities
CMS-10221
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2015-0116/pdf/2015-00627.pdf
Roster key:
Released:
1/16/2015
Due date:
3/17/2015
1. Type of Information Collection Request: Extension of a currently approved
collection; Title: Annual Report on Home and Community Based Services
Waivers and Supporting Regulations; Use: CMS uses this report to compare
actual data to the approved waiver estimates. In conjunction with the waiver
compliance review reports, CMS will compare the information provided to
that in the Medicaid Statistical Information System (MSIS) (CMS-R-284; OMB
0938-0345) report and FFP claimed on the state Quarterly Expenditure
Report (CMS-64; OMB 0938-1265), to determine whether to continue the
state home and community-based services waiver. State estimates of cost
and utilization for renewal purposes are based upon the data compiled in the
CMS-372(S) reports.
2. Type of Information Collection Request: Revision of a currently approved
collection; Title: Outpatient/Ambulatory Surgery Patient Experience of Care
Survey (O/ASPECS); Use: CMS will use the information collected in the
national implementation of Outpatient/Ambulatory Surgery Patient
Experience of Care Survey (A/ASPECS) to: (1) Provide a source of information
for public reporting of selected measures to beneficiaries to help them make
informed decisions for outpatient surgery facility selection; (2) aid facilities
with their internal quality improvement efforts and external benchmarking
with other facilities; and (3) provide the agency with information for
monitoring and public reporting purposes.
3. 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, form 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. As part of
this process, CMS requires verification of compliance with IDTF performance
standards. The site investigation form for IDTFs provides a standardized,
uniform tool to gather information that tells CMS whether an IDTF meets
certain standards (as found in 42 CFR 410.33(g)) and where it practices or
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 43
2015-02-11
Roster of Pending Health-related Federal Regulations
– as of 2/11/2015
renders its services. CMS has used the site investigation form in the past to
aid 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.
Site Investigation for DMEPOS
CMS-R-263
Released:
1/16/2015
PRA Request for Comment
Due date:
3/17/2015
http://www.gpo.gov/fdsys/pkg/FR-2015-0116/pdf/2015-00627.pdf
Verification of Clinic Data--Rural Health
Clinic Form
CMS-29
PRA Request for Comment
Released:
1/23/2015
Due date:
3/24/2015
http://www.gpo.gov/fdsys/pkg/FR-2015-0123/pdf/2015-01128.pdf
Use of Restraint and Seclusion in Psychiatric
Residential Treatment Facilities
CMS-R-306
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2015-0130/pdf/2015-01790.pdf
Roster key:
Released:
1/30/2015
Due date:
3/31/2015
4. 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, form 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. As part of this process, CMS requires verification of compliance with
supplier standards. The site investigation form provided a standardized,
uniform tool to gather information from a DMEPOS supplier that tells CMS
whether it meets certain qualifications (as found in 42 CFR 424.57(c)) and
where it practices or renders its services. CMS has used the site investigation
form in the past to aid 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.
Type of Information Collection Request: Extension of a currently approved
collection; Title: Verification of Clinic Data--Rural Health Clinic Form and
Supporting Regulations; Use: The form serves as an application for 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.
1. Type of Information Collection Request: Extension of a currently approved
collection; Title: Use of Restraint and Seclusion in Psychiatric Residential
Treatment Facilities (PRTFs) for Individuals Under Age 21 and Supporting
Regulations; Use: Psychiatric residential treatment facilities must report
deaths, serious injuries, and attempted suicides to the State Medicaid Agency
and the Protection and Advocacy Organization. They also must provide
residents the restraint and seclusion policy in writing and document in
resident records all activities involving the use of restraint and seclusion.
1/23/2015: Paperwork
Reduction Act notice. No
comments recommended.
1/31/2015: 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 16 of 43
2015-02-11
Roster of Pending Health-related Federal Regulations
– as of 2/11/2015
Cooperative Agreements to Support
Exchanges
CMS-10371
PRA Request for Comment
Released:
1/30/2015
Due date:
3/31/2015
http://www.gpo.gov/fdsys/pkg/FR-2015-0130/pdf/2015-01790.pdf
Consumer Operated and Oriented Program
CMS-10392
Released:
1/30/2015
PRA Request for Comment
Due date:
3/31/2015
http://www.gpo.gov/fdsys/pkg/FR-2015-0130/pdf/2015-01790.pdf
Roster key:
2. Type of Information Collection Request: Revision of a currently approved
collection; Title: Cooperative Agreements to Support Establishment of StateOperated Health Insurance Exchanges; Use: All States (including the 50 States,
consortia of States, and the District of Columbia, herein referred to as States)
had the opportunity under Section 1311(b) of ACA to apply for three types of
grants: (1) Planning grants; (2) Early Innovator grants for early development
of information technology; and (3) Establishment grants to develop,
implement and start up Marketplaces. As of January 1, 2015, the HHS
Secretary has disbursed more than $5.4 billion under this grant program and,
as of that date, has awarded 79 active establishment grants to 28 states. As
the State-Based Marketplaces (SBM) and Small Business Health Options
Program (SHOP) have matured and moved from the developmental phases to
full operation, CMS has modified and streamlined the reporting requirements
for the states to ensure collection of only information necessary to provide
effective oversight of their operations. Given the innovative nature of
Exchanges and the statutorily-prescribed relationship between the HHS
Secretary and States in their development and operation, the HHS Secretary
must work closely with States to provide necessary guidance and technical
assistance to ensure that they can meet the prescribed timelines, federal
requirements, and goals of the statute and the grants awarded to them.
3. Type of Information Collection Request: Revision of a currently approved
collection; Title: Consumer Operated and Oriented (CO-OP) Program; Use:
The Consumer Operated and Oriented Plan (CO-OP), established by Section
1322 of ACA, provides for loans to establish at least one consumer-operated,
qualified nonprofit health insurance issuer in each State. Issuers supported by
the CO-OP program will offer at least one qualified health plan (QHP) at the
silver level of benefits and one at the gold level of benefits in the individual
market State Health Benefit Exchanges (Exchanges). At least two-thirds of
policies or contracts offered by a CO-OP will accept individuals and small
employers. Profits generated by the nonprofit CO-OPs will serve to lower
premiums, improve benefits, improve the quality of health care delivered to
members, expand enrollment, or otherwise contribute to the stability of
coverage offered by the CO-OP. By increasing competition in the health
insurance market and operating with a strong consumer focus, the CO-OP
program will provide consumers more choices, greater plan accountability,
increased competition to lower prices, and better models of care, benefiting
all consumers, not just CO-OP members.
1/31/2015: Paperwork
Reduction Act notice.
No comments
recommended.
1/31/2015: 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 17 of 43
2015-02-11
Roster of Pending Health-related Federal Regulations
– as of 2/11/2015
The CO-OP program will provide nonprofits with loans to fund start-up costs
and State reserve requirements, in the form of Start-Up Loans and Solvency
Loans. An applicant may apply for (1) joint Start-Up and Solvency Loans; or (2)
only a Solvency Loan. Planning Loans seek to help loan recipients determine
the feasibility of operating a CO-OP in a target market. Start-up Loans seek to
assist loan recipients with the many start-up costs associated with
establishing a new health insurance issuer. Solvency Loans seek to assist loan
recipients with meeting the solvency requirements of States in which the
applicant seeks to obtain a license to issue QHPs.
Annual MLR and Rebate Calculation Report
and MLR Rebate Notices
CMS-10418
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2015-0130/pdf/2015-01790.pdf
Released:
1/30/2015
Due date:
3/31/2015
4. Type of Information Collection Request: Revision of a currently approved
collection; Title: Annual MLR and Rebate Calculation Report and MLR Rebate
Notices; Use: Under Section 2718 of ACA and implementing regulations, a
health insurance issuer (issuer) offering group or individual health insurance
coverage must submit a report to the HHS Secretary concerning the amount
the issuer spends each year on claims, quality improvement expenses, nonclaims costs, Federal and State taxes, and licensing and regulatory fees, the
amount of earned premium, and beginning with the 2014 reporting year, the
amounts related to the transitional reinsurance, risk adjustment, and risk
corridors. An issuer must provide an annual rebate if the amount it spends on
certain costs compared to its premium revenue (excluding Federal and States
taxes and licensing and regulatory fees) does not meet a certain ratio,
referred to as the medical loss ratio (MLR).
1/31/2015: Paperwork
Reduction Act notice.
No comments
recommended.
Each issuer must submit annually MLR data, including information about any
rebates it must provide, on a form prescribed by CMS, for each State in which
the issuer conducts business. Each issuer also must provide a rebate notice to
each policyholder owed a rebate and each subscriber of policyholders owed a
rebate for any given MLR reporting year. Additionally, each issuer must
maintain for a period of seven years all documents, records, and other
evidence that support the data included in the annual report to the HHS
Secretary. Under Section 1342 of ACA and implementing regulations, issuers
of qualified health plans (QHPs) must participate in a risk corridors program. A
QHP issuer must pay charges to or receive payments from CMS based on the
ratio of its allowable costs to the target amount. Each QHP issuer must submit
an annual report to CMS concerning its allowable costs, allowable
administrative costs, and the amount of premium.
Based upon experience in the MLR data collection and evaluation process,
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 18 of 43
2015-02-11
Roster of Pending Health-related Federal Regulations
– as of 2/11/2015
CMS has updated its annual burden hour estimates to reflect the actual
numbers of submissions, rebates, and rebate notices. In addition, CMS has
updated its annual burden hour estimates to reflect the additional burden
related to the risk corridors data submission requirements.
The 2014 MLR Reporting Form and instructions reflect changes for the 2014
reporting year and beyond set forth in the March 2013 update to 45 CFR part
158 regarding the MLR reporting and rebate distribution deadlines and the
accounting for the transitional reinsurance, risk adjustment, and risk
corridors. CMS also revised the 2014 MLR Reporting Form and instructions to
include the reporting elements required under the risk corridors data
submission requirements in 45 CFR 153.530. In 2015, issuers likely will send
fewer notices and rebate checks to policyholders and subscribers, reducing
burden for QHP issuers. However, the requirement to report the risk corridors
data will increase burden for QHP issuers. CMS estimates a net reduction in
total burden from 294,911 to 271,600.
Standards for Navigators and NonNavigator Assistance Personnel
CMS-10472
PRA Request for Comment
Released:
1/30/2015
Due date:
3/31/2015
http://www.gpo.gov/fdsys/pkg/FR-2015-0130/pdf/2015-01790.pdf
Consumer Assistance Tools and Certified
Application Counselors
CMS- 10494
PRA Request for Comment
Roster key:
Released:
1/30/2015
Due date:
3/31/2015
5. Type of Information Collection Request: Revision of a currently approved
collection; Title: Standards for Navigators and Non-Navigator Assistance
Personnel; Use: Section 1321(a)(1) of ACA directs and authorizes the HHS
Secretary to issue regulations setting standards for meeting the requirements
under title I of ACA, with respect to, among other things, the establishment
and operation of Exchanges. Pursuant to this authority, regulations finalized
at 45 CFR 155.215(b)(1) require Navigators, as well as those non-Navigator
personnel to whom 45 CFR 155.215 applies, to complete HHS-approved
training for initial certification and annual recertification prior to providing
application and enrollment assistance. The training will include an optional
training quality questionnaire providing Navigators and non-Navigator
assistance personnel to whom 45 CFR 155.215 applies an opportunity to
provide feedback to CMS regarding the training and any improvements that
it can make in the future.
6. Type of Information Collection Request: Extension of a currently approved
collection; Title: Patient Protection and Affordable Care Act; Exchange
Functions: Standards for Navigators and Non-Navigator Assistance Personnel;
Consumer Assistance Tools and Programs of an Exchange and Certified
Application Counselors; Use: Section 1321(a)(1) of ACA directs and authorizes
1/31/2015: Paperwork
Reduction Act notice.
The referenced
questionnaire is not
currently available (CMS–
10494 Standards for
Navigators and NonNavigator Assistance
Personnel; Consumer
Assistance Tools and
Programs of an Exchange
and Certified Application
Counselors). Once available,
it will be reviewed for
possible comments.
1/31/2015: Paperwork
Reduction Act notice.
No 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 19 of 43
2015-02-11
Roster of Pending Health-related Federal Regulations
– as of 2/11/2015
the HHS Secretary to issue regulations setting standards for meeting the
requirements under title I of ACA, with respect to, among other things, the
establishment and operation of Exchanges. Pursuant to this authority, CMS
has finalized regulations establishing the certified application counselor
program at 45 CFR 155.225. In accordance with 155.225(d)(1) and (7),
certified application counselors in all Exchanges must obtain initial
certification and recertification on at least an annual basis and successfully
complete Exchange-required training.
http://www.gpo.gov/fdsys/pkg/FR-2015-0130/pdf/2015-01790.pdf
Questionnaire Testing and Methodological
Research for Medicare Beneficiary Survey
CMS-10549
PRA Request for Comment
Released:
1/30/2015
Due date:
3/31/2015
http://www.gpo.gov/fdsys/pkg/FR-2015-0130/pdf/2015-01790.pdf
7. Type of Information Collection Request: New collection; Title: Generic
Clearance for Questionnaire Testing and Methodological Research for the
Medicare Current Beneficiary Survey (MCBS); Use: This OMB clearance
package seeks to clear a Generic Clearance to support an effort to evaluate
the operations and content of the Medicare Current Beneficiary Survey
(MCBS). MCBS--a continuous, multipurpose survey of a nationally
representative sample of aged, disabled, and institutionalized Medicare
beneficiaries sponsored by CMS--serves as the only comprehensive source of
information on the health status, health care use and expenditures, health
insurance coverage, and socioeconomic and demographic characteristics of
the entire spectrum of Medicare beneficiaries.
The core of the MCBS includes a series of interviews with a stratified random
sample of the Medicare population, including aged and disabled enrollees,
residing in the community or in institutions. Questions involve enrollee
patterns of health care use, charges, insurance coverage, and payments over
time. Respondents are asked about their sources of health care coverage and
payment, their demographic characteristics, their health and work history,
and their family living circumstances. In addition to collecting information
through the core questionnaire, MCBS collects information on special topics
through supplements.
Tribal Consultation Policy
Treasury (no reference number)
Released:
12/3/2014
Tribal Consultation Policy
Due date:
4/2/2015
http://www.gpo.gov/fdsys/pkg/FR-2014-1203/pdf/2014-28383.pdf
Roster key:
This notice announces an interim policy outlining the guiding principles for all
Department of Treasury (Treasury) bureaus and offices engaging with tribal
Governments on matters with tribal implications. Treasury will update the
policy periodically and refine it as needed to reflect ongoing engagement and
collaboration with tribal partners.
recommended.
1/31/2015: Paperwork
Reduction Act notice.
This PRA may notice be
worth reviewing further to
determine if comments are
warranted on the
procedures and content for
the Medicare beneficiary
survey, in particular with
regard to whether the
sample size for AI/AN is
adequate to generate
statistically valid findings.
12/3/2014: Coordinate
response with NCAI.
1/21/2015: Elliott to check
in with NCAI. IRS may be
invited to Feb MMPC
meeting.
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 43
2015-02-11
Roster of Pending Health-related Federal Regulations
– as of 2/11/2015
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.
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
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2015-0206/pdf/2015-02414.pdf
Roster key:
Released:
2/6/2015
Due date:
4/7/2015
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),
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.
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.
The proposed changes
incorporate changes related
to hospice care and a PPS
system for FQHCs. This PRA
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 43
2015-02-11
Roster of Pending Health-related Federal Regulations
– as of 2/11/2015
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
Released:
2/6/2015
Due date:
4/7/2015
http://www.gpo.gov/fdsys/pkg/FR-2015-0206/pdf/2015-02414.pdf
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.
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.
Distributions from an HSA, Archer MSA or
Medical Advantage MSA
Form 1099-SA
Released:
2/10/2014
Due date:
Roster key:
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).
2/10/2015: 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 22 of 43
2015-02-11
Roster of Pending Health-related Federal Regulations
– as of 2/11/2015
PRA Request for Comment
4/13/2015
IRS has made no changes to this form.
Released:
2/11/2014
Type of Information Collection Request: Extension of a currently approved
collection; Title: Initial Plan Data Collection to Support Qualified Health Plan
(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.
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.
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
CMS-10433
PRA Request for Comment
Due date:
4/13/2015
http://www.gpo.gov/fdsys/pkg/FR-2015-0211/pdf/2015-02852.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
Roster key:
Released:
7/24/2014
Due date:
None
2/11/2015: Paperwork
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.
7/30/2014: No comment
requested.
Associated with IRS REG104579-113 and TD-9863.
8/1: See analysis to the left.
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 43
2015-02-11
Roster of Pending Health-related Federal Regulations
– as of 2/11/2015
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
prior.
4.
Adjustments are rounded to hundredth of a percentage point.
5.
The adjusted percentages are applicable to tax years and plan years
after 2014.
6.
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%.
Affordability percentage
1.
This measure is used to determine if someone is eligible for an
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 43
2015-02-11
Roster of Pending Health-related Federal Regulations
– as of 2/11/2015
exemption due to health insurance options not being “affordable.”
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.]
2.
Federal Matching Shares for Medicaid and
CHIP for FY 2016
HHS (no reference number)
Federal Financial Participation in State
Assistance Expenditures; Federal Matching
Shares for Medicaid, the Children’s Health
Insurance Program, and Aid to Needy Aged,
Blind, or Disabled Persons for October 1,
2015, Through September 30, 2016
Released:
12/2/2014
Due date:
None
http://www.gpo.gov/fdsys/pkg/FR-2014-1202/pdf/2014-28398.pdf
Medicaid DSH Payments: Uninsured
Definition
CMS-2315-F
Medicaid Program; Disproportionate Share
Hospital Payments--Uninsured Definition
http://www.gpo.gov/fdsys/pkg/FR-2014-1203/pdf/2014-28424.pdf
Released:
12/3/2014
Due date:
None
HHS has calculated the Federal Medical Assistance Percentages (FMAP),
Enhanced Federal Medical Assistance Percentages (eFMAP), and disasterrecovery FMAP adjustments for FY 2016 pursuant to the Social Security Act
(the Act). These percentages will take effect from October 1, 2015, through
September 30, 2016. This notice announces the calculated FMAP rates that
HHS will use in determining the amount of federal matching for state medical
assistance (Medicaid), Temporary Assistance for Needy Families (TANF)
Contingency Funds, Child Support Enforcement collections, Child Care
Mandatory and Matching Funds of the Child Care and Development Fund,
Foster Care Title IV-E Maintenance payments, and Adoption Assistance
payments, as well as the eFMAP rates for the CHIP expenditures. This notice
also contains the increased eFMAP rates for CHIP as authorized under ACA for
FY 2016 through FY 2019 (October 1, 2015, through September 30, 2019).
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
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.
No comments requested or
recommended.
1/5/2015: See analysis to
the left comparing tribal
recommendations and the
final rule issued by CMS.
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.
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.
Roster key:
Tribal Consultation: CMS did not engage in tribal consultation on 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 25 of 43
2015-02-11
Roster of Pending Health-related Federal Regulations
– as of 2/11/2015
proposed rule as required; CMS should engage in consultation with
AI/ANs prior to issuing the final rule.
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
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
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 26 of 43
2015-02-11
Roster of Pending Health-related Federal Regulations
– as of 2/11/2015
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]
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
Roster key:
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:
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 43
2015-02-11
Roster of Pending Health-related Federal Regulations
– as of 2/11/2015
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
501(c)(3) organization will not be considered a ‘hospital organization’ solely
as a result of operating such a tribal facility.” [78 FR 20525]
Determining Mental Health Professional
Shortage Areas of Greatest Need
HRSA (no reference number)
Determining Mental Health Professional
Shortage Areas of Greatest Need
http://www.gpo.gov/fdsys/pkg/FR-2015-0114/pdf/2015-00398.pdf
Roster key:
Released:
1/14/2015
Due date:
None
In accordance with the requirements of section 333A(b)(1) of the Public
Health Service Act (PHS Act), as amended by the Health Care Safety Net
Amendments of 2002, the HHS Secretary must establish the criteria used to
make determinations under section 333A(a)(1)(A) of health professional
shortage areas (HPSAs) with the greatest shortages. This notice sets forth
revised criteria for determining mental health HPSAs with the greatest
shortages. This notice updates the previous criteria published on May 30,
2003.
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 43
2015-02-11
Roster of Pending Health-related Federal Regulations
– as of 2/11/2015
NOTE: HRSA initially issued criteria for mental health HPSAs in May 2003, and
these were supposed to remain in effect until the issuance of a rule by HHS.
In February 2008, HHS released a proposed rule, titled “Designation of
Medically Underserved Populations and Health Professional Shortage Areas,”
with a 60-day comment period. HHS extended this comment period twice
before deciding to shelve the existing proposed rule and issue a new one (this
did not occur). Although tribal organizations might have commented, this rule
proposed no changes to the criteria for mental health HPSAs established in
the May 2003 HRSA notice and updated in this HRSA notice.
Q&A on Outreach by Medicaid Managed
Care Contractors to Former Enrollees
CCIIO (no reference number)
Initial
Release:
2/21/2014
Question and Answer on Outreach by
Medicaid Managed Care Contractors and
Health Insurance Issuers to Former Enrollees
Due date:
None
http://www.cms.gov/CCIIO/Resources/FactSheets-and-FAQs/Downloads/medicaid-mcoenrollee-outreach-faq-2-21-14.pdf
Updated:
1/15/2015
http://www.cms.gov/CCIIO/Resources/FactSheets-and-FAQs/Downloads/MCOs-1-1515.pdf
2016 Actuarial Value Calculator
Methodology
Roster key:
Released:
1/16/2015
ACA required the HHS Secretary to establish a rulemaking committee to draft
an interim final rule for designation of medically underserved populations
(MUPs) and HPSAs. The rulemaking committee could not reach the consensus
required to produce an interim final rule for review and approval by the HHS
secretary. However, ACA still requires the HHS Secretary to issue an interim
final rule at some point in the future.
Medicaid managed care organizations (MCOs), which provide coverage to
beneficiaries on a risk basis, have existed since before the enactment of the
ACA. Many individuals once enrolled in a Medicaid managed care plan might
no longer qualify for Medicaid as determined by States. Many issuers that
contract with States as MCOs have become involved in offering Qualified
Health Plans (QHPs) on the Federally-Facilitated Marketplace or in StateBased Marketplaces, providing coverage to previously uninsured individuals.
This guidance answers the question of whether an issuer with a Medicaid
MCO contract can reach out to former enrollees who States disenrolled
because of a loss of Medicaid eligibility to assist them in enrolling in health
coverage offered by the issuer through the Marketplace. According to this
guidance: “Yes. An issuer with a Medicaid MCO contract can reach out to
former Medicaid MCO enrollees to assist them in enrolling in health
coverage, provided it does not violate applicable marketing rules
prohibiting discrimination ...”
Update (1/15/2015): This document removes the following sentence from the
end of the answer included in the previous version of this guidance:
“However, a Medicaid MCO may not reach out to current Medicaid
beneficiaries.”
Under the Essential Health Benefits, Actuarial Value, and Accreditation final
rule (EHB Final Rule) published in the February 25, 2013, Federal Register (78
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 43
2015-02-11
Roster of Pending Health-related Federal Regulations
– as of 2/11/2015
CCIIO (no reference number)
Final 2016 Actuarial Value Calculator
Methodology
Due date:
None
http://www.cms.gov/CCIIO/Resources/Regul
ations-and-Guidance/Downloads/Final-2016AV-Calculator-Methodology.pdf
FR 12834), HHS requires use of an Actuarial Value (AV) Calculator by issuers
of non-grandfathered health insurance plans offered in the individual and
small group markets, both inside and outside of the Affordable Insurance
Exchanges (or Marketplaces) for the purposes of determining levels of
coverage. Section 1302(d)(2)(A) of ACA stipulates that AV be calculated based
on the provision of essential health benefits (EHB) to a standard population.
The statute groups health plans into four tiers: bronze, with an AV of 60
percent; silver, with an AV of 70 percent; gold, with an AV of 80 percent; and
platinum, with an AV of 90 percent. The EHB Final Rule establishes that a de
minimis variation of +/-2 percentage points of AV is allowed for each tier.
The AV Calculator represents an empirical estimate of the AV calculated in a
manner that provides a close approximation to the actual average spending
by a wide range of consumers in a standard population. This document is
meant to detail the specific methodologies used in the AV calculation.
This document revises the 2015 version and updates the draft 2016 version,
released on November 21, 2014, in response to comments received.
Specifically, this document incorporates updates to account for the final 2016
AV Calculator. The first part of this document provides background that
includes an overview of the regulation allowing HHS to make updates to the
AV Calculator, as well as the updates incorporated into the final 2016 AV
Calculator. For the second part of the document, CCIIO provides a detailed
description of the development of the standard population and the AV
Calculator methodology. The first section details the data and methods used
in constructing the continuance tables involved in calculating AV in
combination with the user inputs. The second section describes the AV
Calculator interface and the calculation of actuarial value based on the
interface and the continuance tables. The final 2016 AV Calculator is available
at: http://www.cms.gov/CCIIO/Resources/Regulations-andGuidance/Downloads/Final-2016-AV-Calculator-011514.xlsm. CCIIO notes
that this does not affect any 2015 plans and applies only for 2016 plans.
Annual Update of the HHS Poverty
Guidelines
HHS (no reference number)
Annual Update of the HHS Poverty
Guidelines
Roster key:
Released:
1/22/2015
Due date:
None
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.
1/22/2015: No response
required/requested.
A table comparing the 2015 HHS poverty guidelines with the 2014 guidelines
is embedded below.
These poverty level figures
will be used for Medicaid
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 43
2015-02-11
Roster of Pending Health-related Federal Regulations
– as of 2/11/2015
http://www.gpo.gov/fdsys/pkg/FR-2015-0122/pdf/2015-01120.pdf
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
Penalty Relief Related to Advance Payments
of the Premium Tax Credit for 2014
http://www.irs.gov/pub/irs-drop/n-1509.pdf
Released:
1/26/2015
Due date:
None
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
the premium tax credit against the premium tax credit allowed on the tax
return. Specifically, this notice provides relief from the penalty under §
6651(a)(2) of the Internal Revenue Code for late payment of a balance due
and the penalty under § 6654(a) for underpayment of estimated tax. To
qualify for the relief, taxpayers must meet certain requirements described in
this notice. This relief applies only for the 2014 taxable year.
 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
payments on a 2014 tax return timely filed, including extensions
 Taxpayers should be aware that this Notice does not extend
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.
1/31/2015: No comments
requested or
recommended.
the time to file a return.

Roster key:
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,
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 43
2015-02-11
Roster of Pending Health-related Federal Regulations
– as of 2/11/2015


Interest Rate on Overdue Debts
HHS (no reference number)
Released:
1/27/2015
Notice of Interest Rate on Overdue Debts
Due date:
None
http://www.gpo.gov/fdsys/pkg/FR-2015-0127/pdf/2015-01429.pdf
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.”
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.
Section 30.18 of HHS claims collection regulations (45 CFR part 30) provides
that the HHS Secretary shall charge an annual rate of interest determined and
fixed by the Secretary of the Treasury after considering private consumer
rates of interest on the date that HHS becomes entitled to recovery. The rate
must equal or exceed the current value of funds rate set by the Department
of the Treasury or the applicable rate determined from the “Schedule of
Certified Interest Rates with Range of Maturities,” unless the HHS Secretary
waives interest in whole or part or a statute, contract, or repayment
agreement prescribes a different rate. The Secretary of the Treasury can
revise this rate quarterly. HHS publishes this rate in the Federal Register.
The current rate of 10 1⁄2%, as fixed by the Secretary of the Treasury, is
certified for the quarter ended December 31, 2014. This interest rate--based
on the Interest Rates for Specific Legislation, “National Health Services Corps
Scholarship Program” and “National Research Service Award Program”--will
apply to overdue debt until HHS publishes a revision.
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-andRoster key:
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.
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 43
2015-02-11
Roster of Pending Health-related Federal Regulations
– as of 2/11/2015
Education/American-Indian-AlaskaNative/AIAN/Downloads/AIANsSpecialProtections-Fact-Sheet.pdf
No response requested.
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
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.
http://www.cms.gov/Outreach-andEducation/American-Indian-AlaskaNative/AIAN/Downloads/AIAN-TrustIncome-and-MAGI-FactSheet.pdf
Test Tools and Procedures for the ONC HIT
Certification Program
HHS ONC (no reference number)
Notice of Availability: Test Tools and Test
Procedures Approved by the National
Coordinator for the ONC HIT Certification
Program
No response requested
Released:
1/28/2015
Due date:
None
http://www.gpo.gov/fdsys/pkg/FR-2015-0128/pdf/2015-01535.pdf
Quarterly Listing of Medicare and Medicaid
Issuances
CMS-9088-N
Medicare and Medicaid Programs; Quarterly
Listing of Program Issuances--October
Through December 2014
1/26/2015: Handout
prepared and released by
CMS on Indian-specific
income provisions under the
ACA, Medicaid and federal
law.
Released:
2/2/2015
Due date:
None
This notice announces the availability of test tools and test procedures
approved by the National Coordinator for Health Information Technology (the
National Coordinator) for the testing of EHR technology to the 2014 Edition
Release 2 EHR certification criteria under the HHS ONC HIT Certification
Program. The approved test tools and test procedures are identified on the
HHS ONC Web site at: http://healthit.gov/policy-researchersimplementers/testing-and-test-methods. HHS ONC has not yet approved the
test tools and test procedures for the “optional--transitions of care”
certification criterion (§ 170.314(b)(8)) and the optional testing and
certification for the “view, download, and transmit to 3rd party” certification
criterion (§ 170.314(e)(1)).
This quarterly notice lists CMS manual instructions, substantive and
interpretive regulations, and other Federal Register notices published from
October through December 2014, relating to the Medicare and Medicaid
programs and other programs administered by CMS.
http://www.gpo.gov/fdsys/pkg/FR-2015-0202/pdf/2015-01904.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 33 of 43
2015-02-11
Roster of Pending Health-related Federal Regulations
– as of 2/11/2015
Extended Moratoria on Enrollment of
Ambulance Suppliers and HHAs
CMS-6059-N2
Medicare, Medicaid, and Children’s Health
Insurance Programs: Announcement of the
Extended Temporary Moratoria on
Enrollment of Ambulance Suppliers and
Home Health Agencies in Designated
Geographic Locations
http://www.gpo.gov/fdsys/pkg/FR-2015-0202/pdf/2015-01696.pdf
Changes to Medicare Part C and Part D for
CY 2016
CMS-4159-F2
Medicare Program; Contract Year 2016
Policy and Technical Changes to the
Medicare Advantage and the Medicare
Prescription Drug Benefit Programs
https://s3.amazonaws.com/publicinspection.federalregister.gov/201502671.pdf
Released:
2/2/2015
Due date:
None
Released:
2/6/2015
Published:
2/12/2015
(expected)
Due date:
None
This document announces the extension of temporary moratoria on the
enrollment of new ambulance suppliers and home health agencies (HHAs) in
specific locations within designated metropolitan areas in Florida, Illinois,
Michigan, Texas, Pennsylvania, and New Jersey to prevent and combat fraud,
waste, and abuse.
This final rule amends the Medicare Advantage (MA) program (Part C)
regulations and Medicare Prescription Drug Benefit Program (Part D)
regulations to implement statutory requirements; improve program
efficiencies; strengthen beneficiary protections; clarify program
requirements; improve payment accuracy; and make various technical
changes. Additionally, this rule finalizes two technical changes that reinstate
previously approved but erroneously removed regulation text sections.
2/11/2015: See analysis of
CMS-4159-F2 to the left and
in the attached document.
Analysis: Tribal organizations did not file comments on the proposed
rule.
This final rule addresses one Indian-specific issue. In this rule, CMS
finalized two new provisions related to efficient dispensing of
medications in long-term care facilities (§423.154(a)(2) and (a)(3)) (see
item 4 in section C below). Previously, §423.154(c) waived all
requirements under §423.154(a) for I/T/U pharmacies. However, this
final rule revises the language of §423.154(c) to clarify that the new
provisions do apply to I/T/U pharmacies.
See attached analysis for a review of additional issues.
CMS-4159-F2
analysis 2015-02-10b.docx
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 34 of 43
2015-02-11
Roster of Pending Health-related Federal Regulations
– as of 2/11/2015
Medicare Secondary Payer and “Future
Medicals” (CMS-6047-P)
Received at
OMB:
8/1/2013
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.
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
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)
Electronic Health Record (EHR) Incentive
Programs--Stage 3 (CMS-3310-P)
Received at
OMB:
9/18/2014
Roster key:
Received at
OMB:
9/18/2014
Received at
OMB:
12/31/2014
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
Program (Part A). The Medicare statute specifies the formula used to
determine these amounts.
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.
No detail provided.
This proposed rule would establish policies related to Stage 3 of meaningful
use for the Medicare and Medicaid EHR Incentive Programs. Stage 3 will
focus on improving health care outcomes and further advance
interoperability.
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 35 of 43
2015-02-11
Roster of Pending Health-related Federal Regulations
– as of 2/11/2015
2015 Edition Health Information Technology
(Health IT) Certification Criteria, Base
Electronic Health Record (EHR) Definition,
and ONC Health IT Certification Program
Modifications (HHS OIG RIN 0991-AB93 )
Received at
OMB:
12/31/2014
Mental Health Parity and Addiction Equity
Act of 2008; the Application to Medicaid
Managed Care, CHIP, and Alternative Benefit
Plans (CMS-2333-P)
Reimbursement Rates for Calendar Year
2015 (IHS RIN 0917-ZA29)
Received at
OMB:
1/7/2015
CY 2016 Notice of Benefit and Payment
Parameters (CMS-9944-F)
Received at
OMB:
1/17/2015
Received at
OMB:
1/29/2015
Basic Health Program; Federal Funding
Methodology for Program Year 2016 (CMS2391-FN)
Received at
OMB:
1/29/2015
Pre-Existing Condition Insurance Plan
Program Updates (CMS-9995-IFC4)
Received at
OMB:
2/3/2015
This proposed rule (2015 Edition health IT certification criteria or 2015
Edition) would establish a new 2015 Edition Base EHR definition and modify
the ONC Health IT Certification Program to make it more broadly applicable
to other types of health IT health care settings and programs that might
leverage the ONC Health IT Certification Program. The 2015 Edition also
would establish the technical capabilities and specify the related standards
and implementation specifications that Certified Electronic Health Record
(EHR) Technology would need to include to, at a minimum, support the
achievement of meaningful use by eligible professionals eligible hospitals
and critical access hospitals under the Medicare and Medicaid EHR Incentive
Programs when such edition is required for use under these programs.
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).
No detail provided.
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 provides additional standards for the annual
open enrollment period for 2016, essential health benefits, network
adequacy, essential community providers, quality improvement strategies,
the sale of non-qualified health plans through Exchanges, the good faith
compliance enforcement safe harbor, a suppression status for QHPs, the
Small Business Health Options Program, guaranteed availability and
guaranteed renewability, minimum essential coverage, and the medical loss
ratio program.
No detail provided.
No detail provided.
DoL and IRS/Treasury
Health Insurance Premium Assistance Trust
Received at
No detail provided.
Supporting the Purchase of Certain
OMB:
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 36 of 43
2015-02-11
Roster of Pending Health-related Federal Regulations
– as of 2/11/2015
Individual Health Insurance Policies-Exclusion from Definition of Employee
Welfare Benefit Plan (DoL RIN 1210-AB57)
Family and Medical Leave Act of 1993, as
Amended (DoL RIN 1235-AA09)
8/24/2013
Received at
OMB:
1/9/2015
The Family Medical Leave Act (FMLA) entitles eligible employees of covered
employers to take unpaid, job-protected leave for specified family and
medical reasons with continuation of group health insurance under the same
terms and conditions as if the employee had taken leave. Eligible employees
can take FMLA leave, among other reasons, to care for a spouse who has a
serious health condition. DoL proposes to revise the definition of “spouse” in
light of the U.S. Supreme Court decision in United States v. Windsor.
OPM
None.
Revisions to Safe Harbors Under the AntiKickback Statute, et al.
OIG-403-P3
Medicare and State Health Care Programs:
Fraud and Abuse; Revisions to Safe Harbors
Under the Anti-Kickback Statute, and Civil
Monetary Penalty Rules Regarding
Beneficiary Inducements and Gainsharing
Released:
10/3/2014
Due date:
12/2/2014
http://www.gpo.gov/fdsys/pkg/FR-2014-1003/pdf/2014-23182.pdf
RECENTLY SUBMITTED COMMENTS
This proposed rule would amend the safe harbors to the anti-kickback statute
and the civil monetary penalty (CMP) rules under the authority of the HHS
Office of Inspector General (OIG). The proposed rule would add new safe
harbors, some of which codify statutory changes set forth in the Medicare
Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) and
ACA and all of which would protect certain payment practices and business
arrangements from criminal prosecution or civil sanctions under the antikickback statute. OIG also proposes to codify revisions to the definition of
“remuneration,” added by the Balanced Budget Act (BBA) of 1997 and ACA,
and add a gainsharing CMP provision in its regulations.
A summary of the major provisions of this proposed rule appears below.
Anti-Kickback Statute and Safe Harbors
This proposed rule would amend 42 CFR 1001.952 by modifying certain
existing safe harbors to the anti-kickback statute and by adding safe harbors
that provide new protections or codify certain existing statutory protections.
11/24/2014: A summary of
the provisions of this
proposed rule and specific
requests for comments
prepared by Sam Ennis is
embedded below.
2014-11-24 Summary
of OIG-403-P3.docx
12/2/2014: TTAG filed
comments (embedded
below).
120214 TTAG
Comments on OIG403P3 - FINAL.pdf
In addition, this proposed rule would codify the gainsharing CMP set forth in
section 1128A(b) of the Social Security Act (the Act) (42 U.S.C. 1320a-7a(b)).
Potential Revisions to Criteria for
Permissive Exclusion Authority
OIG-1271-N
Roster key:
Released:
7/11/2014
This notice informs the public that HHS OIG: (1) will consider revising the
Non-Binding Criteria for Implementing Permissive Exclusion Authority Under
7/11/2014: Comments may
Section 1128(b)(7) of the Social Security Act (Act); and (2) seeks input from
be warranted to advise
Due date:
the public to consider in developing the revised criteria. Section 1128(b)(7) of
HHS/OIG on how 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 37 of 43
2015-02-11
Roster of Pending Health-related Federal Regulations
– as of 2/11/2015
Solicitation of Information and
Recommendations for Revising OIG’s NonBinding Criteria for Implementing Permissive
Exclusion Authority Under Section 1128(b)(7)
of the Social Security Act
http://www.gpo.gov/fdsys/pkg/FR-2014-0711/pdf/2014-16222.pdf
http://www.gpo.gov/fdsys/pkg/FR-2014-1029/pdf/2014-25681.pdf
9/9/2014
12/29/2014
[NOTE: No
content
changes
were made
when the
date was
extended.]
the Act authorizes the HHS Secretary, and by delegation OIG, to exclude an
individual or entity from participation in Federal health care programs for
engaging in conduct described in sections 1128A and 1128B of the Act. In the
October 24, 1997, Federal Register (62 FR 55410), OIG published a proposed
policy statement in the form of non-binding criteria for use in assessing
whether to impose a permissive exclusion under section 1128(b)(7) of the
Act. In the December 24, 1997, Federal Register (62 FR 67392), OIG
published the final policy statement.
Since 1997, OIG has used these criteria to evaluate whether to impose a
permissive exclusion under section 1128(b)(7) of the Act or release this
authority in exchange for the defendant entering into an Integrity Agreement
with OIG. On the basis of its experience evaluating permissive exclusion in
False Claims Act and administrative cases over the past 17 years, OIG plans to
revise the existing criteria. OIG believes revised criteria might help the
provider community understand how OIG exercises its discretion in cases
under section 1128(b)(7) of the Act. OIG also believes that updated guidance
could better reflect the state of the health care industry today, including the
changes in legal requirements and the emergence of the health care
compliance industry.
In considering possible revisions to the criteria, OIG seeks comments,
recommendations, and other suggestions from concerned parties on how to
revise the criteria to address relevant issues and to provide useful guidance
to the health care industry. The issues that OIG will consider include: (1)
Whether differences in the criteria should exist for individuals and entities
and (2) whether and how to consider the existing compliance program of a
defendant.
Due date extension (10/29/2014): This document announces an extension of
the public comment period for the HHS OIG notice published in the July 11,
2014, Federal Register (79 FR 40114). The notice solicited input from the
public on revising the criteria used by HHS OIG in implementing its permissive
exclusion authority under Section 1128(b)(7) of the Social Security Act. Due to
a technical problem, the public might not have had the ability to submit
comments at http://www.regulations.gov during the comment period.
Accordingly, HHS OIG has extended the comment period to ensure that the
public has an opportunity to provide input.
Roster key:
guidance should be revised
pertaining to the permissive
exclusion authority.
7/23/2014: Sam to review.
8/13&20: Sam summarized
that no comments are
required, except to
comment that any exclusion
related to I/T/Us should be
individual-specific and not
the entire facility. Also, may
provide an opportunity to
raise general tribal
priorities. Sam will draft.
8/27/2014: Elliott
suggested that this may not
be a good vehicle for an
Indian-specific provision.
Elliott will speak with Sam.
9/4/2014: Draft comments
linked below.
9/9/2014: Comments
submitted by TTAG.
2014-09-08 Final
TTAG Comments on OIG-1271-N - Permissive
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 43
2015-02-11
Roster of Pending Health-related Federal Regulations
– as of 2/11/2015
HHS Notice of Benefit and Payment
Parameters for 2016
CMS-9944-P
Patient Protection and Affordable Care Act;
HHS Notice of Benefit and Payment
Parameters for 2016
Released:
11/21/2014
Published:
12/26/2014
Due date:
12/22/2014
http://www.gpo.gov/fdsys/pkg/FR-2014-1126/pdf/2014-27858.pdf
This proposed rule would set forth payment parameters and provisions
related to the risk adjustment, reinsurance, and risk corridors programs; costsharing parameters and cost-sharing reductions; and user fees for FederallyFacilitated Exchanges. It also would provide additional standards for the
annual open enrollment period for the individual market for benefit years
beginning on or after January 1, 2016, essential health benefits, qualified
health plans, network adequacy, quality improvement strategies, the Small
Business Health Options Program, guaranteed availability, guaranteed
renewability, minimum essential coverage, the rate review program, the
medical loss ratio program, and other related topics.
12/22/2014: TTAG, NIHB
and TSGAC comments filed.
TSGAC
Final-CMS-9944 Notice of Ben and Pay Param
A fact sheet on this proposed rule is available at
http://www.cms.gov/CCIIO/Resources/Fact-Sheets-andFAQs/Downloads/Fact-Sheet-11-20-14.pdf
Also attached is a copy of the prior tribal recommendations on requiring
issuers to provide a SBC (Summary of Benefits and Coverage) for each (Indianspecific) plan variation.
TTAG Letter to
CCIIO - QHPs and AI-AN CS Var 2014-05-29 FINAL.pdf
Draft 2016 Letter to Issuers in FFMs
CCIIO (no reference number)
Released:
12/19/2014
Draft 2016 Letter to Issuers in the FederallyFacilitated Marketplaces
Due date:
1/12/2015
http://www.cms.gov/CCIIO/Resources/Regul
ations-andGuidance/Downloads/2016DraftLettertoIssu
ers12-19-2014.pdf
Roster key:
This draft 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.
1/12/2015: Comments filed
by TTAG and TSGAC.
TTAG Comments on
CCIIO Issuer Letter.pdf
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
Marketplace-related topics appear in 45 CFR Subtitle A, Subchapter B.
Additional proposed requirements appear in a proposed rule titled, “Patient
Protection and Affordable Care Act; HHS Notice of Benefit and Payment
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 43
2015-02-11
Roster of Pending Health-related Federal Regulations
– as of 2/11/2015
Parameters for 2016” (2016 Payment Notice proposed rule), CMS-9944-P,
published on November 26, 2014.
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 as a result of an industry-standard internal compliance and risk
management program. QHP issuers in the FFMs also might have to meet
other requirements for plan years beginning in 2016, as indicated in future
rulemaking.
CMS requests comments on this proposed guidance. To the extent that this
guidance summarizes policies proposed through other rulemaking processes
not yet finalized, such as the rulemaking process for the 2016 Payment Notice
proposed rule, stakeholders should comment on those underlying policies
through the ongoing rulemaking processes and not through the comment
process for this Letter. Please send comments on other aspects of this Letter
to FFEcomments@cms.hhs.gov by January 12, 2015.
Health Benefit Plan Network Access and
Adequacy Model Act
NAIC (no reference number)
Health Benefit Plan Network Access and
Adequacy Model Act (Draft)
http://www.naic.org/documents/committee
s_b_rftf_namr_sg_exposure_draft_proposed
_revisions_mcpna_model_act.pdf
Roster key:
Released:
11/12/2014
Due date:
1/12/2015
CMS requests that interested parties should organize comments by
subsections of this Letter.
This draft Act includes model language regarding network adequacy in health
plans. The Act seeks to:
1.
2.
Establish standards for the creation and maintenance of networks by
health carriers; and
Assure the adequacy, accessibility, transparency, and quality of
health care services offered under a network plan by (1) establishing
requirements for written agreements between health carriers
offering network plans and participating providers regarding the
standards, terms, and provisions under which the participating
provider will provide covered benefits to covered persons and (2)
requiring network plans to have and maintain publicly available
access plans consistent with Section 5B of this Act that consist of
policies and procedures for assuring the ongoing sufficiency of
provider networks.
1/7/2015: An analysis from
Mim Dixon with suggested
comments is embedded
below.
NAIC Model Act
Comments, 1-7-15.docx
1/12/2015: TTAG submitted
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 40 of 43
2015-02-11
Roster of Pending Health-related Federal Regulations
– as of 2/11/2015
NAIC seeks comments on this draft Act by January 12, 2015. The revisions to
this version of the Act reflect changes made from the existing model.
Interested parties should submit comments by e-mail only to Jolie Matthews
at jmatthews@naic.org.
TTAG NAIC Network
Adequacy Model Act Comment.pdf
Information regarding the NAIC Network Adequacy Model Review (B)
Subgroup, responsible for reviewing and considering revisions to the Act, is
available at http://www.naic.org/committees_b_rftf_namr_sg.htm.
Section 102(c) of the Veterans Access,
Choice, and Accountability Act of 2014
VA (no reference number)
Section 102(c) of the Veterans Access,
Choice, and Accountability Act of 2014
http://www.gpo.gov/fdsys/pkg/FR-2014-1230/pdf/2014-30527.pdf
Released:
12/30/2014
Due date:
1/14/2015
As required by section 102(c) of the Veterans Access, Choice, and
Accountability Act of 2014, the VA Secretary and the IHS Director will jointly
submit to Congress a report on the feasibility and advisability of entering into
and expanding certain reimbursement agreements. VA seeks Tribal
Consultation on section 102(c).
12/30/2014: The VA seeks
tribal consultation.
Specifically, VA seeks Tribal Consultation in the form of written comments
concerning the feasibility and advisability of IHS and tribal health programs
entering into agreements with VA for reimbursement of the costs of direct
care services provided to eligible veterans who are not AI/ANs.
1/7/2014: According to
Sam, Myra is preparing an
analysis of the proposed
rules and may be able to
share with MMPC.
See “Expanded Access to Non-VA Care Through Veterans Choice Program”
entry below for information on the new program.
1/9/2015: Elliott is
preparing draft comments.
darrenj@tribalselfgov.org
Summary of Section 102
Section 102, titled, “Enhancement of Collaboration Between Department of
Veterans Affairs and Indian Health Service,” directs the VA Secretary, in
consultation with the IHS Director, to conduct outreach to each medical
facility operated by a Tribe or tribal organization through a contract or
compact with the IHS under ISDEAA to raise awareness of the ability of such
facilities, Tribes, and tribal organizations to enter into agreements under
which VA reimburses them for health care provided to veterans who are 1)
eligible for health care at such facilities and 2) enrolled in the VA patient
enrollment system (or fall under a certain limited exception).
Section 102 also requires the VA Secretary to establish metrics for assessing
the performance by VA and IHS in increasing access to health care, improving
quality and coordination of health care, promoting effective patient-centered
collaboration and partnerships between VA and IHS, and ensuring healthpromotion and disease-prevention services are appropriately funded and
Roster key:
1/13/2015: Draft comments
are embedded below.
DELETED.
1/14/2015: Comments filed
on NIHB and TSGAC
letterhead.
TSGAC Ltr to Tracy
Parker Warren- OPIA-VA re Comments VA Agr
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 43
2015-02-11
Roster of Pending Health-related Federal Regulations
– as of 2/11/2015
available for beneficiaries under both health care systems.
I/T/U Payment for Physician and NonHospital-Based Services
IHS (RIN 0917-AA12)
Payment for Physician and Other Health
Care Professional Services Purchased by
Indian Health Programs and Medical Charges
Associated with Non-Hospital-Based Care
[AKA Medicare-Like Rates]
http://www.gpo.gov/fdsys/pkg/FR-2014-1205/pdf/2014-28508.pdf
http://www.gpo.gov/fdsys/pkg/FR-2015-0114/pdf/2015-00400.pdf
Released:
12/4/2014
Published:
12/5/2014
Due date:
1/20/2015
2/4/2015 –
DATE
EXTENDED
In addition, under section 102, within 180 days of enactment, the VA
Secretary and IHS Director must jointly submit to Congress a report on the
feasibility and advisability of the following:
1. Entering into agreements for the reimbursement by VA of the costs of
direct care services provided through organizations receiving amounts
pursuant to grants made or contracts entered into under section 503 of
the Indian Health Care Improvement Act to veterans who are otherwise
eligible to receive health care from such organizations; and
2. Including the reimbursement of the costs of direct care services
provided to veterans who are not AI/ANs in agreements between VA
and IHS or a Tribe or tribal organization operating a medical facility
through a contract or compact with the IHS under ISDEAA
This proposed rule would amend IHS Purchased and Referred Care (PRC),
formally known as Contract Health Services (CHS), regulations to apply
Medicare payment methodologies to all physician and other health care
professional services and non-hospital based services either authorized under
such regulations or purchased by urban Indian organizations (UIOs).
Specifically, it proposes that the health programs operated by IHS, Tribes,
tribal organizations, or UIOs (collectively, I/T/U programs) will pay the lowest
of the amount provided for under the applicable Medicare fee schedule,
prospective payment system, or Medicare waiver; the amount negotiated by
a repricing agent, if available; or the usual and customary billing rate. IHS
might use repricing agents to determine whether it would benefit from
savings by utilizing negotiated rates offered through commercial health care
networks. This proposed rule seeks comment on how to establish
reimbursement that remains consistent across Federal health care programs,
aligns payment with inpatient services, and enables IHS to expand beneficiary
access to medical care.
Due date extension (1/14/2014): This document extends the comment period
for the Payment for Physician and Other Health Care Professional Services
Purchased by Indian Health Programs and Medical Charges Associated with
Non-Hospital-Based Care proposed rule published in December 5, 2014,
Federal Register (79 FR 72160). This document extends the comment period
for the proposed rule, which would have ended on January 20, 2015, to
February 4, 2015.
Roster key:
12/4/2014: Informal
version of proposed rule
released. Formal published
version expected
12/5/2014.
12/5/2014: Published
version of proposed rule on
Medicare-Like-Rates linked
to left.
1/21/2015: The next tribalonly call is scheduled for
1/23/2014 at 11:00 EST.
Devin will send out call info.
2/2/2015: Please see
suggested template to the
left for tribal organizations
to base comments.
2/4/2015: Comments 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 42 of 43
2015-02-11
Roster of Pending Health-related Federal Regulations
– as of 2/11/2015
A template for Tribes and tribal organizations to use in submitting their
comments on this proposed rule is embedded below. This new template
includes additional language at the bottom of page 1 clarifying what type of
rule, “final” or “interim” that IHS should implement.
by NIHB and other tribal
organizations.
NIHB Comment on
MLR.pdf
Updated Tribal
Comments on MLR Proposed Rule Template.docx
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 43 of 43
2015-02-11