Roster of Pending Health-related Federal Regulations
– as of 1/26/2015
Lead Agency: SHORT TITLE
Reference Number; Title of Reg/Agency
Action
I/T/U Payment for Physician and NonHospital-Based Services
IHS (RIN 0917-AA12)
Agency release
date; due date
Agency’s Summary of Action
for comments
Released:
This proposed rule would amend IHS Purchased and Referred Care (PRC),
12/4/2014
formally known as Contract Health Services (CHS), regulations to apply
Medicare payment methodologies to all physician and other health care
Published:
professional services and non-hospital based services either authorized under
Payment for Physician and Other Health
12/5/2014
such regulations or purchased by urban Indian organizations (UIOs).
Care Professional Services Purchased by
Specifically, it proposes that the health programs operated by IHS, Tribes,
Indian Health Programs and Medical Charges Due date:
tribal organizations, or UIOs (collectively, I/T/U programs) will pay the lowest
Associated with Non-Hospital-Based Care
1/20/2015
of the amount provided for under the applicable Medicare fee schedule,
2/4/2015 –
prospective payment system, or Medicare waiver; the amount negotiated by
[AKA Medicare-Like Rates]
DATE
a repricing agent, if available; or the usual and customary billing rate. IHS
EXTENDED
might use repricing agents to determine whether it would benefit from
http://www.gpo.gov/fdsys/pkg/FR-2014-12savings by utilizing negotiated rates offered through commercial health care
05/pdf/2014-28508.pdf
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
http://www.gpo.gov/fdsys/pkg/FR-2015-01access to medical care.
14/pdf/2015-00400.pdf
Notes:
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.
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.
Medicaid Eligibility and Enrollment IAPD
Released:
1. Type of Information Collection Request: New collection; Title: Medicaid
Template
12/19/2014
Eligibility and Enrollment (EE) Implementation Advanced Planning Document
12/19/2014: Paperwork
CMS-10536
(IAPD) Template; Use: To assess the appropriateness of state requests for
Reduction Act notice.
Due date:
enhanced federal financial participation for expenditures related to Medicaid
PRA Request for Comment
1/20/2015
eligibility determination systems, CMS will review the submitted information
and documentation to make an approval determination for the advanced
http://www.gpo.gov/fdsys/pkg/FR-2014-12planning document. CMS has revised this package subsequent to the
19/pdf/2014-29739.pdf
publication of the 60-day notice in the August 29, 2014Federal Register (79
FR 51571).
CY 2016 Plan Benefit Package Software and
Released:
2. Type of Information Collection Request: Revision of a currently approved
Formulary Submission
12/19/2014
collection; Title: CY 2016 Plan Benefit Package (PBP) Software and Formulary
12/19/2014: Paperwork
CMS-R-262
Submission; Use: CMS requires that Medicare Advantage and Prescription
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.
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– as of 1/26/2015
PRA Request for Comment
Due date:
1/20/2015
http://www.gpo.gov/fdsys/pkg/FR-2014-1219/pdf/2014-29739.pdf
National CLAS Standards in Health and
Health Care
HHS-OS-0990-New-30D
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2014-1219/pdf/2014-29740.pdf
Released:
12/19/2014
Due date:
1/20/2015
Drug Plan organizations submit a completed PBP and formulary as part of the
annual bidding process. During this process, organizations prepare their
proposed plan benefit packages for the upcoming contract year and submit
them to CMS for review and approval. CMS publishes beneficiary education
information using a variety of formats. The specific education initiatives that
utilize PBP and formulary data include Web application tools on
www.medicare.gov and the plan benefit insert in the Medicare & You
handbook. In addition, organizations utilize the PBP data to generate their
Summary of Benefits marketing information. CMS has revised this package
subsequent to the publication of the 60-day notice in the September 26,
2014, Federal Register (79 FR 57931).
Type of Information Collection Request: New collection; Title: National
Standards for Culturally and Linguistically Appropriate Services (CLAS) in
Health and Health Care: Evaluation of Awareness, Adoption, and
Implementation; Use: The HHS Office of Minority Health (OMH) seeks new
OMB approval for data collection on an evaluation project titled “National
Standards for Culturally and Linguistically Appropriate Services (CLAS) in
Health and Health Care: Evaluation of Awareness, Adoption, and
Implementation.” This assessment seeks to describe and examine
systematically the awareness, knowledge, adoption, and implementation of
the HHS OMH National Standards for Culturally and Linguistically Appropriate
Services in Health and Health Care (National CLAS Standards) in a sample of
health and health care organizations and to use the resultant data to develop
a preliminary model of implementation to guide organizational adoption and
implementation of the National CLAS Standards. Originally released in 2001,
the HHS OMH National CLAS Standards include recommended action steps
intended to advance health equity, improve quality, and help eliminate health
care disparities. The National CLAS Standards, revised in 2013, include 15
Standards that provide health and health care organizations with a blueprint
for successfully implementing and maintaining culturally and linguistically
appropriate services.
Reduction Act notice.
12/19/2014: Paperwork
Reduction Act notice.
Despite increased recognition of the National CLAS Standards as a
fundamental tool for health and health care organizations to use in their
efforts to become more culturally and linguistically competent, neither the
original nor the enhanced National CLAS Standards have undergone
systematic evaluation in terms of public awareness, organizational adoption
and implementation, or impact on health services outcomes. A need exists to
collect information from health and health care organizations to understand
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.
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– as of 1/26/2015
how and to what extent the intended audiences have utilized the National
CLAS Standards.
Amendments to Excepted Benefits
REG-132751-14
DoL (RIN 1210-AB70)
CMS-9946-P2
Released:
12/23/2014
Due date:
1/22/2015
This document contains proposed rules that would amend the regulations
regarding excepted benefits under ERISA, the Internal Revenue Code (the
Code), and the Public Health Service Act related to limited wraparound
coverage. Excepted benefits generally are exempt from the requirements
added to those laws by HIPAA and ACA.
Amendments to Excepted Benefits
Background: The 2013 proposed regulations outlined requirements under
which certain employer-sponsored wraparound coverage provided under a
group health plan would be treated as excepted benefits when offered to
individuals who could have received the benefits provided in the wraparound
coverage through their employer’s primary group health plan, however the
primary plan is unaffordable and they do not enroll in that primary plan. The
2013 proposed regulations were intended to allow a plan sponsor to pursue
equity in coverage by maintaining a comparable level of benefits for all
potential enrollees, including not only higher-income workers enrolled in the
employer’s primary group health plan but also lower-income workers,
enrolled in non-grandfathered individual market coverage. Under the 2013
proposed regulations, employer-provided wraparound coverage would
constitute excepted benefits (limited wraparound coverage) and therefore
would not disqualify an employee from eligibility for the premium tax credit
and cost-sharing reductions, if five conditions were met.
http://www.gpo.gov/fdsys/pkg/FR-2014-1223/pdf/2014-30010.pdf
Summary of Benefits and Coverage and
Uniform Glossary
CMS-10407
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2014-1124/pdf/2014-27756.pdf
Documents are linked at:
Roster key:
Released:
11/24/2014
Due date:
1/23/2015
After consideration of comments on the 2013 proposed regulations, the
Departments are publishing these proposed regulations to address limited
wraparound coverage and solicit comment before promulgation of final
regulations on limited wraparound benefits.
1. Type of Information Collection Request: Extension of a currently approved
collection; Title: Summary of Benefits and Coverage and Uniform Glossary;
Use: Section 2715 of the Public Health Service Act directs HHS, the
Department of Labor (DoL), and the Department of the Treasury (collectively,
the Departments), in consultation with the National Association of Insurance
Commissioners (NAIC) and a working group comprised of stakeholders, to
“develop standards for use by a group health plan and a health insurance
issuer in compiling and providing to applicants, enrollees, and policyholders
and certificate holders a summary of benefits and coverage explanation that
accurately describes the benefits and coverage under the applicable plan or
12/24/2014: The proposed
rule provides a series of
conditions that must apply
in order for certain wraparound benefits to be
considered “excepted
benefits”, and thereby do
not impact an employee’s
ability to access premium
tax credits in an Exchange if
the individuals are
otherwise eligible for
premium tax credits.
11/24/2014: Paperwork
Reduction Act notice.
Linked documents include a
blank “Summary of
Coverage” template. This is
the document tribal reps
have requested – and CMS
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
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http://www.cms.gov/Regulations-andGuidance/Legislation/PaperworkReductionA
ctof1995/PRA-ListingItems/CMS1251222.html?DLPage=1&DLFilte
r=10407&DLSort=1&DLSortDir=descending
Medicare and Medicaid OASIS Collection
Requirements as Part of the CoPs for HHAs
CMS-R-245
PRA Request for Comment
coverage.” To implement these disclosure requirements, collection of
information requests relate to the provision of the following: summary of
benefits and coverage, which includes coverage examples; a uniform glossary
of health coverage and medical terms; and a notice of modifications.
Released:
11/24/2014
Due date:
1/23/2015
http://www.gpo.gov/fdsys/pkg/FR-2014-1124/pdf/2014-27756.pdf
agreed to in CMS-9944 in
December 2014--that CMS
require QHPs to provide for
Indian-specific cost-sharing
variations.
2. 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.
Bid Pricing Tool for Medicare Advantage
and Prescription Drug Plans
CMS-10142
Released:
12/24/2014
Due date:
Roster key:
Type of Information Collection Request: Revision of a currently approved
collection; Title: Bid Pricing Tool (BPT) for Medicare Advantage (MA) Plans
and Prescription Drug Plans (PDP); Use: CMS requires that Medicare
Advantage organizations and Prescription Drug Plans complete the Bid Pricing
12/23/2014: 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.
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PRA Request for Comment
1/23/2015
http://www.gpo.gov/fdsys/pkg/FR-2014-1224/pdf/2014-30026.pdf
HCAHPS Survey Mode Experiment
CMS-10542
Released:
11/28/2014
PRA Request for Comment
Due date:
1/27/2015
http://www.gpo.gov/fdsys/pkg/FR-2014-1128/pdf/2014-28137.pdf
Emergency Department Patient Experience
of Care Survey Mode Experiment
CMS-10543
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2014-1128/pdf/2014-28137.pdf
Roster key:
Released:
11/28/2014
Due date:
1/27/2015
Tool (BPT) as part of the annual bidding process. During this process,
organizations prepare their proposed actuarial bid pricing for the upcoming
contract year and submit them to CMS for review and approval. BPT seeks to
collect the actuarial pricing information for each plan. For each plan, BPT
calculates the bid, enrollee premiums, and payment rates. CMS publishes
beneficiary premium information using a variety of formats
(www.medicare.gov, the Medicare & You handbook, Summary of Benefits
marketing information) for the purpose of beneficiary education and
enrollment.
1. Type of Information Collection Request: New collection; Title: Hospital
Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey
Mode Experiment; Use: CMS publicly reports hospital-level scores derived
from national implementation of Hospital Consumer Assessment of
Healthcare Providers and Systems (HCAHPS) Survey on its Hospital Compare
Web site. The HCAHPS initiative allows vendors to select one mode of survey
administration from four approved administration protocols (mail only,
telephone only, mail-telephone mixed mode, and touch-tone IVR only).
Before public reporting, CMS adjusts HCAHPS scores for the selected mode of
administration, using mail administration as the comparison mode, to correct
for any inflation or deflation of scores that result from mode. The current
mode adjustments employed for HCAHPS are the product of two separate
mode experiments conducted using different versions of the survey and
different sample. The planned HCAHPS mode experiment seeks to conduct a
mode experiment of sufficient sample and scale to determine if the mode
adjustments currently employed for the 32-item HCAHPS core survey need
revision. An additional goal involves collecting empirical evidence on the
effect of the number of additional supplemental items on survey response
rate and patterns of response to the HCAHPS core demographic items (known
as “About You” items).
2. Type of Information Collection Request: New collection; Title: Emergency
Department Patient Experience of Care (EDPEC) Survey Mode Experiment;
Use: This survey supports the six national priorities for improving care from
the National Quality Strategy developed by HHS as directed under ACA to
create national aims and priorities to guide local, state, and national efforts to
improve the quality of health care. The six priorities include: making care
safer by reducing harm caused by the delivery of care; ensuring the
engagement of each individual and family as partners in their care; promoting
effective communication and coordination of care; promoting the most
effective prevention and treatment practices for the leading causes of
12/1/2014: Paperwork
Reduction Act notice.
12/1/2014: 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.
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Laboratory Personnel Report
CMS-209
Released:
11/28/2014
PRA Request for Comment
Due date:
1/27/2015
http://www.gpo.gov/fdsys/pkg/FR-2014-1128/pdf/2014-28137.pdf
FFS Recovery Audit Prepayment Review and
Prior Authorization Demonstrations
CMS-10421
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2014-1230/pdf/2014-30468.pdf
Released:
12/30/2014
Due date:
1/29/2015
mortality, starting with cardiovascular disease; working with communities to
promote wide use of best practices to enable healthy living; and making
quality care more affordable for individuals, families, employers, and
governments by developing and spreading new health care delivery models.
In 2012, CMS launched the development of the Emergency Department
Patient Experience of Care Survey (EDPEC) to measure the experiences of
patients (18 and older) with emergency department care. This survey will
provide patient experience with care data that enables comparisons of
emergency department and support for improving the quality of patient
experience in the emergency department.
3. Type of Information Collection Request: Extension without change of a
currently approved collection; Title: Laboratory Personnel Report (CLIA) and
Supporting Regulations; Use: The information collected on this survey form
serves the administrative pursuit of the congressionally mandated program
with regard to regulation of laboratories participating in CLIA. The surveyor
will provide the laboratory with CMS-209. While the surveyor performs other
aspects of the survey, the laboratory will complete CMS-209 by recording the
personnel data needed to support their compliance with the personnel
requirements of CLIA. The surveyor will then use this information in choosing
a sample of personnel to verify compliance with the personnel requirements.
Information on personnel qualifications of all technical personnel ensures
that the sample is representative of the entire laboratory.
Type of Information Collection Request: Extension of a currently approved
collection; Title: Fee-for-Service Recovery Audit Prepayment Review
Demonstration and Prior Authorization Demonstration; Use: On July 23, 2012,
OMB approved the collections required for two demonstrations of
prepayment review and prior authorization. The first demonstration allows
Medicare Recovery Auditors to review claims on a pre-payment basis in
certain States. The second demonstration established a prior authorization
program for Power Mobility Device claims in certain States.
12/1/2014: Paperwork
Reduction Act notice.
12/230/2014: Paperwork
Reduction Act notice.
For the Recovery Audit Prepayment Review Demonstration, CMS and its
agents request additional documentation, including medical records, to
support submitted claims. As discussed in more detail in Chapter 3 of the
Program Integrity Manual, additional documentation includes any medical
documentation, beyond that included on the face of the claim, that supports
the billed item or service. For Medicare to consider coverage and payment for
any item or service, the information submitted by the provider or supplier
(e.g., claims) must include the documentation in the medical records of the
Roster key:
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 6 of 41
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– as of 1/26/2015
patient. When conducting complex medical review, the contractor specifies
documentation they require in accordance with Medicare rules and policies.
In addition, providers and suppliers can supply additional documentation not
explicitly listed by the contractor. CMS and its agents might request this
supporting information on a routine basis in instances where diagnoses on a
claim do not clearly indicate medical necessity, or a suspicion of fraud exists.
HSA, Archer MSA, or Medicare Advantage
MSA Information
Form 5498-SA 2014 and Form 5498-SA 2015
PRA Request for Comment
Released:
12/30/2014
Due date:
1/29/2015
http://www.gpo.gov/fdsys/pkg/FR-2014-1230/pdf/2014-30376.pdf
Continuation Coverage Requirements
Applicable to Group Health Plans
TD 8812 (OMB 1545-1581)
Roster key:
Released:
12/30/2014
For the Prior Authorization of Power Mobility Devices (PMDs) Demonstration,
CMS has begun piloting prior authorization for PMDs. Prior authorization will
allow submission of the applicable documentation that supports a claim
before delivery of the item. For prior authorization, submission of relevant
documentation for review occurs before delivery of the item or rendering og
the service. CMS will conduct this demonstration in California, Florida, Illinois,
Michigan, New York, North Carolina, Texas, Pennsylvania, Ohio, Louisiana,
Missouri, Maryland, New Jersey, Indiana, Kentucky, Georgia, Tennessee,
Washington, and Arizona based on beneficiary address as reported to the
Social Security Administration and recorded in the Common Working File
(CWF). For the demonstration, the (ordering) physician or treating
practitioner can complete a prior authorization request and submit it to the
appropriate DME MAC for an initial decision. The supplier also can submit the
request on behalf of the physician or treating practitioner. Under this
demonstration, the submitter will submit to the DME MAC a request for prior
authorization and all relevant documentation to support Medicare coverage
of the PMD item.
41. Type of Information Collection Request: Revision of a currently approved
collection; Title: HSA, Archer MSA, or Medicare Advantage MSA Information;
Use: Internal Revenue Code (Code) Section 220(h) requires trustees to report
to IRS and medical savings account holders contributions to and the year-end
fair market value of any contributions made to a medical savings account
(MSA). Congress requires Treasury to report the total contributions made to
an MSA for the current tax year. Section 1201 of the Medicare Prescription
Drug, Improvement, and Modernization Act of 2003 created new Code
section 223. Section 223(h) requires the reporting of contributions to and the
year-end fair market value of health savings accounts for tax years beginning
after December 31, 2003.
42. Type of Information Collection Request: Extension of a currently approved
collection; Title: Continuation Coverage Requirements Applicable to Group
Health Plans; Use: The regulations require group health plans to provide
12/230/2014: Paperwork
Reduction Act notice.
12/230/2014: Paperwork
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 7 of 41
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Due date:
1/29/2015
notices to individuals entitled to elect COBRA (The Consolidated Omnibus
Budget Reconciliation Act of 1985) continuation coverage of their election
rights. Individuals who wish to obtain the benefits provided under the statute
must provide plans notices in the cases of divorce from the covered
employee, a dependent child ceasing to be dependent under the terms of the
plan, and disability. Most plans will require that elections of COBRA
continuation coverage occur in writing. In cases where qualified beneficiaries
are short by an insignificant amount in a payment made to the plan, the
regulations require the plan to notify the qualified beneficiary if the plan does
not wish to treat the tendered payment as full payment. If a health care
provider contacts a plan to confirm coverage of a qualified beneficiary, the
regulations require that the plan disclose the complete rights to coverage for
the qualified beneficiary.
Risk Corridors Transitional Policy
CMS-10532
Released:
1/5/2015
PRA Request for Comment
Due date:
2/4/2015
Type of Information Collection Request: New collection; Title: Risk Corridors
Transitional Policy; Use: Section 1342 of ACA provides for the establishment
of a temporary risk corridors program that will apply to qualified health plans
in the individual and small group markets for the first three years of Exchange
operation. The implementing regulations (CMS-9954-F) for this provision
appear in CFR Part 153, Title 45. Under 45 CFR 153.530(e), each issuer
conducting business in the individual and small group markets in states that
adopted the transitional policy must submit enrollment data, including
enrollment in transitional policies (i.e. individual or small group health
insurance coverage in states that adopted the transitional policy announced
in the CMS letter dated November 14, 2013), on the “Transitional Adjustment
Reporting Form” prescribed by CMS, for each state in which the issuer
conducts business.
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2014-1230/pdf/2014-30376.pdf
http://www.gpo.gov/fdsys/pkg/FR-2015-0105/pdf/2014-30800.pdf
Employer Notification of Objection to
Covering Contraceptive Services
CMS-10535
PRA Request for Comment
Roster key:
Released:
12/8/2014
Due date:
2/6/2015
Reduction Act notice.
CMS will use the data collection to amend the risk corridors program
provisions in 45 CFR part 153 to mitigate any unexpected losses for issuers of
plans subject to risk corridors attributable to the effects of this transitional
policy. Specifically, CMS will use the data to calculate the risk corridors
adjustment percentage, if any, in transitional states.
Type of Information Collection Request: Revision of a currently approved
collection; Title: Employer Notification to HHS of its Objection to Providing
Coverage for Contraceptive Services; Use: The proposed rules titled
“Coverage of Certain Preventive Services Under the Affordable Care Act” (79
FR 51118) would continue to require each closely-held, for-profit corporation
seeking treatment as an eligible organization to provide notification that it
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.
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http://www.gpo.gov/fdsys/pkg/FR-2014-1208/pdf/2014-28632.pdf
will not act as the plan administrator or claims administrator with respect to,
or contribute to the funding of, coverage of all or a subset of contraceptive
services. Issuers and third party administrators providing payments for
contraceptive services for participants and beneficiaries in plans of eligible
organizations would have to meet the notice requirements as set forth in the
2013 final regulations.
The interim final regulations titled “Coverage of Certain Preventive Services
Under the Affordable Care Act” (79 FR 51092) continue to allow eligible
organizations that have religious objections to providing contraceptive
coverage to notify an issuer or third party administrator using EBSA Form 700,
as set forth in the July 2013 final regulations. In addition, the interim final
regulations permit an alternative process under which an eligible organization
could notify the HHS Secretary that it will not act as the plan administrator or
claims administrator with respect to, or contribute to the funding of,
coverage of all or a subset of contraceptive services.
Medicare Shared Savings Program: ACOs
CMS-1461-P
Released:
12/8/2014
Medicare Program; Medicare Shared Savings
Program: Accountable Care Organizations
Due date:
2/6/2015
http://www.gpo.gov/fdsys/pkg/FR-2014-1208/pdf/2014-28388.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-2014-1208/pdf/2014-28650.pdf
Released:
12/8/2014
Due date:
2/6/2015
This proposed rule addresses changes to the Medicare Shared Savings
Program (Shared Savings Program), including provisions relating to the
payment of Accountable Care Organizations (ACOs) participating in the
Shared Savings Program. Under the Shared Savings Program, providers of
services and suppliers that participate in an ACO continue to receive
traditional Medicare fee-for-service (FFS) payments under Parts A and B, but
the ACO might qualify to receive a shared savings payment if it meets
specified quality and savings requirements.
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.
Paperwork Reduction Act
notice.
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
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.
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Federal Health IT Strategic Plan: 2015-2020
HHS ONC (no reference number)
Released:
12/10/2014
Office of the National Coordinator for Health
Information Technology; Federal Health IT
Strategic Plan: 2015-2020 Open Comment
Period
Due date:
2/6/2015
http://www.gpo.gov/fdsys/pkg/FR-2014-1210/pdf/2014-28855.pdf
http://www.npdb.hrsa.gov/. All reporting and querying occurs through this
secure Web site.
Section 3001(c)(3) of the Public Health Service Act, as added by the Health
Information Technology for Economic and Clinical Health (HITECH) Act,
requires the National Coordinator for Health Information Technology (ONC)
to update the Federal Health IT Strategic Plan (developed June 3, 2008; last
updated on September 15, 2011) in consultation with other appropriate
federal agencies and in collaboration with private and public entities. ONC
will seek input on the draft Plan, developed in collaboration across multiple
federal agencies, from the private sector through the Health IT Policy
Committee. This notice serves to announce that the public comment period
for the Federal Health IT Strategic Plan will remain open through Tuesday,
February 6 at 5:00 p.m. ET. ONC welcomes and encourages all comments
from the public regarding the Plan.
Interested parties must submit comments via
http://www.healthit.gov/policy-researchers-implementers/strategic-planpublic-comments.
Challenge and Prize Competition
Solicitations
HHS-OS-0990-0390-60D
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2014-1209/pdf/2014-28705.pdf
Released:
12/9/2014
Due date:
2/9/2015
The plain is available at http://www.healthit.gov/sites/default/files/federalhealthIT-strategic-plan-2014.pdf.
Type of Information Collection Request: Revision of a currently approved
collection; Title: Challenge and Prize Competition Solicitations; Use: In 2011,
Federal agencies including HHS received prize authority for administering
challenges and competitions. Challenges and competitions enable HHS to tap
into the expertise and creativity of the public in new ways. For HHS to launch
quickly and effectively competitions on a continual basis, it seeks generic
clearance to collect information for these challenges and competitions,
generally including first name, last name, e-mail, city, state, and when
applicable, other demographic information. It also can include other
information necessary to evaluate submissions and understand their impact
related to the general goals of the competition.
HHS will use the information collected to understand whether the participant
has met the technical requirements for the challenge, assist in the technical
review and judging of the solutions provided, and understand the impact and
consequences of administering the competition and developing solutions for
submission. HHS might collect information during the competition or after its
completion.
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.
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Coverage of Certain Preventive Services
Under ACA
EBSA Form 700
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2014-1211/pdf/2014-29060.pdf
Released:
12/11/2014
Due date:
2/9/2015
Type of Information Collection Request: Extension of a currently approved
collection; Title: Coverage of Certain Preventive Services Under the
Affordable Care Act; Use: The HHS and the Departments of Labor (DoL) and
Treasury (the Departments) published interim final rules (2010 interim final
rules) on July 19, 2010, to require non-grandfathered group health insurance
coverage to provide benefits for certain preventive services without cost
sharing, including benefits for certain women’s preventive health services as
provided for in comprehensive guidelines supported by HRSA.
Paperwork Reduction Act
notice.
On August 1, 2011, HRSA adopted and released guidelines for women’s
preventive health services, including contraceptive services. On August 3,
2011, the Departments amended the 2010 interim final rules (2011 amended
interim final rules) to provide HRSA with the authority to exempt group
health plans established or maintained by religious employers (and group
health insurance coverage provided in connection with such plans) from the
requirement to cover contraceptive services consistent with the HRSA
guidelines. The 2011 amended interim final rules specified a definition of
religious employer. HRSA exercised its authority in its guidelines to exempt
plans established or maintained by religious employers (and group health
insurance coverage provided in connection with such plans) from the
requirement to cover contraceptive services.
On February 6, 2013, the Departments published proposed rules that
proposed to simplify and clarify the definition of religious employer and also
proposed accommodations for health coverage established or maintained or
arranged by certain nonprofit religious organizations with religious objections
to contraceptive services (eligible organizations). The rules proposed that, for
insured plans, the health insurance issuer providing group health insurance
coverage in connection with the plan would have to assume sole
responsibility, independent of the eligible organization and its plan, for
providing contraceptive coverage to plan participants and beneficiaries
without cost sharing, premium, fee, or other charge to plan participants or
beneficiaries or to the eligible organization or its plan. In the case of selfinsured plans, the proposed regulations presented potential approaches
under which the third party administrator of the plan would provide or
arrange for a third party to provide separate contraceptive coverage to plan
participants and beneficiaries without cost sharing, premium, fee, or other
charge to plan participants or beneficiaries or to the eligible organization or
its plan. The Departments received more than 400,000 comments (many of
Roster key:
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interest to Tribes; struck-through are lowest priority.
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them standardized form letters) in response to the proposed regulations.
After consideration of the comments, the Departments published final
regulations on July 2, 2013. A contemporaneously issued HHS guidance
document extended the temporary safe harbor from enforcement of the
contraceptive coverage requirement by the Departments to encompass plan
years beginning on or after August 1, 2013, and before January 1, 2014. This
guidance included a form for an organization to use during this temporary
period to self-certify that its plan qualifies for the temporary enforcement
safe harbor. In addition, HHS and DoL also issued a self-certification form,
EBSA Form 700, for use by an organization seeking treatment as an eligible
organization for purposes of an accommodation under these final
regulations. HHS and DoL provided this self-certification form for use with the
accommodations under the July 2013 final regulations, after the expiration of
the temporary enforcement safe harbor (i.e., for plan years beginning on or
after January 1, 2014). The rules also provide that the third party
administrator and issuer required to provide or arrange payments for
contraceptive services must provide plan participants and beneficiaries with
written notice of the availability of separate payments for contraceptive
services contemporaneous with, but separate from, any application materials
distributed in connection with enrollment for group health coverage for each
plan year to which the accommodation applies.
On July 3, 2014, the Supreme Court of the United States issued an interim
order in connection with an application for an injunction in the pending case
of Wheaton College v. Burwell, ruling, “If [Wheaton College] informs the
Secretary of Health and Human Services in writing that it is a non-profit
organization that holds itself out as religious and has religious objections to
providing coverage for contraceptive services, the [Departments of Labor,
Health and Human Services, and the Treasury] are enjoined from enforcing
against [Wheaton College]” certain provisions of ACA and related regulations
requiring coverage without cost sharing of certain contraceptive services
“pending final disposition of appellate review” (Wheaton order). The order
stated that Wheaton College need not use EBSA Form 700 or send a copy of
the executed form to its health insurance issuers or third party administrators
to meet the condition for this injunctive relief. The order also stated that it
neither affected “the ability of [Wheaton College’s] employees and students
to obtain, without cost, the full range of FDA approved contraceptives,” nor
precluded the federal government from relying on the notice it receives from
Roster key:
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interest to Tribes; struck-through are lowest priority.
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Wheaton College “to facilitate the provision of full contraceptive coverage
under the Act.”
On August 27, 2014, the Departments issued interim final regulations in light
of the Supreme Court interim order concerning notification to the federal
government that an eligible organization has a religious objection to
providing contraceptive coverage, as an alternative to the EBSA Form 700,
and to preserve participant and beneficiary access to coverage for the full
range of FDA-approved contraceptives, as prescribed by a health care
provider, without cost sharing, consistent with the Supreme Court order.
Revisions to Conditions of Participation and
Conditions for Coverage
CMS-3302-P
Medicare and Medicaid Program; Revisions
to Certain Patient’s Rights Conditions of
Participation and Conditions for Coverage
http://www.gpo.gov/fdsys/pkg/FR-2014-1212/pdf/2014-28268.pdf
ACA Information and Collection
Requirements for Section 1115 Projects
CMS-10341
PRA Request for Comment
Released:
12/12/2014
Due date:
2/10/2015
Released:
12/12/2014
Due date:
2/10/2015
http://www.gpo.gov/fdsys/pkg/FR-2014-1212/pdf/2014-29172.pdf
Medicare Consumer Assessment of
Healthcare Providers and Systems Survey
CMS-R-246
Released:
12/12/2014
Due date:
Roster key:
On August 27, 2014, OMB approved the changes as a revision to OMB 12100150 under the emergency procedures for review and clearance in
accordance with the Paperwork Reduction Act of 1995. OMB approval of the
revision currently will expire on February 28, 2015.
This proposed rule would revise the applicable conditions of participation
(CoPs) for providers, conditions for coverage (CfCs) for suppliers, and
requirements for long-term care facilities to ensure that certain requirements
conform with the Supreme Court decision in United States v. Windsor, 570
U.S.12, 133 S.Ct. 2675 (2013), and HHS policy. Specifically, CMS proposes to
revise certain definitions and patients’ rights provisions to ensure that samesex spouses in legally valid marriages receive equal rights in Medicare and
Medicaid participating facilities.
1. Type of Information Collection Request: Extension of a currently approved
collection; Title: Affordable Care Act Information and Collection
Requirements for Section 1115 Demonstration Projects; Use: CMS needs this
collection to ensure that states comply with regulatory and statutory
requirements related to the development, implementation, and evaluation of
demonstration projects. States seeking waiver authority under Section 1115
must meet certain requirements for public notice, the evaluation of
demonstration projects, and reports to the HHS Secretary on the
implementation of approved demonstrations.
2. Type of Information Collection Request: Revision of a currently approved
collection; Title: Medicare Advantage, Medicare Part D, and Medicare FeeFor-Service Consumer Assessment of Healthcare Providers and Systems
(CAHPS) Survey; Use: The Medicare consumer assessment of healthcare
Paperwork Reduction Act
notice.
Paperwork Reduction Act
notice.
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interest to Tribes; struck-through are lowest priority.
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PRA Request for Comment
2/10/2015
providers and systems (CAHPS) surveys serve to provide information to
Medicare beneficiaries to help them make more informed choices among
health and prescription drug plans available to them. The surveys also
provide data to help CMS and others monitor the quality and performance of
Medicare health and prescription drug plans and identify areas to improve
the quality of care and services provided to enrollees of these plans.
Released:
12/12/2014
3. Type of Information Collection Request: New collection; Title: Transcatheter
Mitral Valve Repair (TMVR) National Coverage Decision (NCD); Use: The CMS
National Coverage Determination (NCD) titled, “Transcatheter Mitral Valve
Repair (TMVR),” requires this data collection. Medicare covers the TMVR
device only when specific conditions are met, including that the heart team
and hospital submit data in a prospective, national, audited registry. The data
includes patient-, practitioner-, and facility-level variables that predict
outcomes such as all-cause mortality and quality of life.
http://www.gpo.gov/fdsys/pkg/FR-2014-1212/pdf/2014-29172.pdf
Transcatheter Mitral Valve Repair National
Coverage Decision
CMS-10531
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2014-1212/pdf/2014-29172.pdf
Due date:
2/10/2015
Paperwork Reduction Act
notice.
The Society of Thoracic Surgery/American College of Cardiology
Transcatheter Valve Therapy (STS/ACC TVT) Registry, one registry overseen by
the National Cardiovascular Data Registry, meets the requirements specified
in the NCD on TMVR. The TVT Registry will support a national surveillance
system to monitor the safety and efficacy of the TMVR technologies for the
treatment of mitral regurgitation (MR). The data also will include the
variables on the eight item Kansas City Cardiomyopathy Questionnaire
(KCCQ-10) to assess heath status, functioning, and quality of life. The KCCQ
allows the derivation of an overall summary score from the physical function,
symptoms (frequency and severity), social function, and quality of life
domains.
The data collected and analyzed in the TVT Registry will help determine if
TMVR is reasonable and necessary (e.g., improves health outcomes) for
Medicare beneficiaries under Section 1862(a)(1)(A) of the Social Security Act.
Furthermore, data from the Registry will assist the medical device industry
and the FDA in surveillance of the quality, safety, and efficacy of new medical
devices to treat mitral regurgitation. For purposes of the TMVR NCD, the TVT
Registry has contracted with the Data Analytic Centers to conduct the
analyses. In addition, CMS will make data available for research purposes
under the terms of a data use agreement that only provides de-identified
datasets.
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.
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Survey of Retail Prices
CMS-10241
Released:
12/19/2014
PRA Request for Comment
Due date:
2/17/2015
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
Released:
12/19/2014
Due date:
2/17/2015
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
Released:
12/19/2014
Due date:
2/17/2015
http://www.gpo.gov/fdsys/pkg/FR-2014-1219/pdf/2014-29741.pdf
National Provider Identifier Application and
Update Form
CMS-10114
PRA Request for Comment
Roster key:
Released:
1/16/2015
Due date:
2/17/2015
1. Type of Information Collection Request: Extension of a currently approved
collection; Title: Survey of Retail Prices: Payment and Utilization Rates and
Performance Rankings; Use: This study has two parts. Part I focuses on the
retail community pharmacy consumer prices. It also includes reporting by the
states of payment and utilization rates for the 50 most widely prescribed
drugs and comparing state drug payment rates with the national retail survey
prices. (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.
2. Type of Information Collection Request: Extension of a currently approved
collection; Title: External Quality Review (EQR) of Medicaid Managed Care
Organizations (MCOs) and Supporting Regulations; Use: State agencies must
provide to the EQR organization (EQRO) information obtained through
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.
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.
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
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.
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interest to Tribes; struck-through are lowest priority.
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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
Released:
12/22/2014
Due date:
2/20/2015
http://www.gpo.gov/fdsys/pkg/FR-2014-1222/pdf/2014-29837.pdf
Rural Health Network Development
Program
HRSA (OMB 0915-xxxx)
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2014-1222/pdf/2014-29772.pdf
Roster key:
Released:
12/22/2014
Due date:
2/20/2015
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.
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.
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
12/19/2014: Paperwork
Reduction Act notice.
12/19/2014: Paperwork
Reduction Act notice.
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interest to Tribes; struck-through are lowest priority.
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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.
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
Released:
1/23/2014
Due date:
2/23/2015
http://www.gpo.gov/fdsys/pkg/FR-2015-0123/pdf/2015-01127.pdf
Annual Eligibility Redetermination, Product
Discontinuation, and Renewal Notices
CMS-10527
Released:
1/23/2014
Due date:
Roster key:
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.
1.
12/19/2014: Paperwork
Reduction Act notice.
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).
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
1/23/2015: Paperwork
Reduction Act notice. No
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interest to Tribes; struck-through are lowest priority.
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PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2015-0123/pdf/2015-01127.pdf
2/23/2015
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.
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
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.
Roster key:
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interest to Tribes; struck-through are lowest priority.
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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
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
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.
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:
1.
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
Roster key:
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 numbers: 93.971,
93.123, and 93.972
Key dates:
--Application deadline:
2/28/2015, for continuing
students
--Application deadline:
3/28/2015, for new
students
--Application review: 5/11-
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.
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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’’
Released:
10/21/2014
Due date:
3/2/2015
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
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.
http://www.gpo.gov/fdsys/pkg/FR-2014-1021/pdf/2014-24918.pdf
5/22/2015
--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
The statutory authority for this challenge competition appears in Section 105
of the America COMPETES Reauthorization Act of 2010.
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-2014-12Roster key:
Published:
12/30/2014
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.
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
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.
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30/pdf/2014-30243.pdf
A CMS fact sheet on these proposed regulations is available at
http://www.cms.gov/CCIIO/Resources/Fact-Sheets-andFAQs/Downloads/SBC-Proposed-Rule-Fact-Sheet-122214.pdf
HHS also released a press release describing the proposed rule.
HHS Interg
Notification SBC 2014-12.pdf
Links to a number of proposed supporting materials related the SBC and
uniform glossary appear below:
Proposed SBC Blank Template:
http://www.cms.gov/CCIIO/Resources/Regulations-andGuidance/Downloads/blank-template-12-19-14-FINAL.pdf
Proposed Uniform Glossary:
http://www.cms.gov/CCIIO/Resources/Regulations-andGuidance/Downloads/Uniform-Glossary-12-19-14-FINAL.pdf
(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.
There are no Indian-specific
provisions in this proposed
rule.
1/20/2015: Review of the
proposed rule in the
document below.
CMS-9938-P
Summary of Benefits and Coverage 2015-01-2
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
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.
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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
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
Solicitation of New Safe Harbors and
Special Fraud Alerts
OIG-123-N
Solicitation of New Safe Harbors and Special
Fraud Alerts
Released:
12/30/2014
Due date:
3/2/2015
In accordance with section 205 of HIPAA, this annual notice solicits
proposals and recommendations for developing new and modifying existing
safe harbor provisions under the Federal anti-kickback statute (section
1128B(b) of the Social Security Act), as well as developing new HHS OIG
Special Fraud Alerts.
12/30/2014: This request
for comments provides
another opportunity to
tribal representatives to
make a case for I/T/Uspecific safe harbors.
http://www.gpo.gov/fdsys/pkg/FR-2014-12Roster 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.
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30/pdf/2014-30156.pdf
Expanded Access to Non-VA Care Through
Veterans Choice Program
VA (RIN 2900-AP24)
Expanded Access to Non-VA Care Through
the Veterans Choice Program
http://www.gpo.gov/fdsys/pkg/FR-2014-1105/pdf/2014-26316.pdf
http://www.gpo.gov/fdsys/pkg/FR-2014-1121/pdf/2014-27581.pdf
1/21/2014: Myra and Elliott
may re-draft and resubmit
previously submitted
recommendations. Possibly
ask OIG attend next TTAG
meeting.
Released:
11/5/2014
Due date:
3/5/2015
VA amends its medical regulations concerning its authority for eligible
veterans to receive care from non-VA entities and providers. The Veterans
Access, Choice, and Accountability Act of 2014 directs VA to establish a
program to furnish hospital care and medical services through non-VA health
care providers to veterans who either cannot receive care within the waittime goals of the Veterans Health Administration or who qualify based on
their place of residence (the Veterans Choice Program, or the “Program”).
The law also requires VA to publish an interim final rule establishing this
program. This interim final rule defines the parameters of the Veterans
Choice Program and clarifies aspects affecting veterans and the non-VA
providers that will furnish hospital care and medical services through the
Veterans Choice Program.
Analysis: Under “eligible entities and providers”, the following definition is
provided” “Section 17.1530 defines requirements for non-VA entities and
health care providers to be eligible to be reimbursed for furnishing hospital
care and medical services to eligible veterans under the Program. Paragraph
(a) of this section provides that an entity or provider must be accessible to
the veteran and be one of the four entities specified in section 101(a)(1)(B) of
the Act. These include any health care provider that is participating in the
Medicare program under title XVIII of the Social Security Act (42 U.S.C. 1395
et seq.), including any physician furnishing services under such program; any
Federally-qualified health center (as defined in section 1905(l)(2)(B)
of the Social Security Act (42 U.S.C. 1396d(l)(2)(B)); the Department of
Defense; or the Indian Health Service. Outpatient health programs or
facilities operated by a tribe or tribal organization under the Indian 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).”
11/6/2014: This interim
final rule was issued by the
VA to implement the new
private care option
authorized by Congress.
11/12: Sam to review with
Myra on eligibility criteria to
confirm all I/T/Us are
included.
1/20/2015: Comments
submitted by TSGAC on a
related VA request for tribal
consultation show below:
TSGAC Comments VA
Agreements dated 1-14-15.pdf
1/21/2015: Myra to
prepare first draft of
comments.
Under this definition, I/T/U are included as eligible providers either as being a
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.
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Medicare participating provider or as an FQHC under SSA 42 U.S.C.
1396d(l)(2)(B).
FEHBP: Rate Setting for Community-Rated
Plans
OPM (RIN 3206-AN00)
Federal Employees Health Benefits Program;
Rate Setting for Community-Rated Plans
http://www.gpo.gov/fdsys/pkg/FR-2015-0107/pdf/2014-30633.pdf
Administrative Requirements for DRA
Section 6071
CMS-10249
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2015-0109/pdf/2015-00175.pdf
Roster key:
Released:
1/7/2015
Due date:
3/9/2015
Released:
1/9/2015
Due date:
3/10/2015
Notice of start date (11/21/2014): In the interim final rule, VA established
start dates for participation in the Veterans Choice Program (the
“Program”) for different groups of veterans depending upon their basis of
eligibility to participate. In those regulations, VA stated that veterans
eligible based upon their inability to schedule an appointment within the
wait-time goals of the Veterans Health Administration can start receiving
hospital care and medical services under the Program no later than
December 5, 2014. VA also stated that, if these veterans had a start date
earlier than December 5, 2014, VA would publish a notice in the Federal
Register advising the public of the faster implementation schedule. This
notice announces that November 17, 2014, serves as the start date for
veterans eligible to participate in the Program.
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.
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
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.
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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
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
Roster key:
Released:
1/16/2015
Due date:
3/17/2015
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.
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
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.
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http://www.gpo.gov/fdsys/pkg/FR-2015-0116/pdf/2015-00627.pdf
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
Tribal Consultation Policy
Treasury (no reference number)
Released:
12/3/2014
Tribal Consultation Policy
Due date:
Roster key:
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
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.
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.
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
1/23/2015: Paperwork
Reduction Act notice. No
comments recommended.
12/3/2014: Coordinate
response with NCAI.
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.
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4/2/2015
collaboration with tribal partners.
Released:
7/24/2014
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.
http://www.gpo.gov/fdsys/pkg/FR-2014-1203/pdf/2014-28383.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
Due date:
None
1/21/2015: Elliott to check
in with NCAI. IRS may be
invited to Feb MMPC
meeting.
7/30/2014: No comment
requested.
Associated with IRS REG104579-113 and TD-9863.
8/1: See analysis to the left.
Analysis:
For 2015 and subsequent years, adjustments to-1.
The percentages will be updated by the ratio of premium growth in
the preceding calendar year to income growth in the preceding
calendar year.
2.
Premium growth is measured by per enrollee spending for
employer-sponsored health insurance in the preceding year to per
enrollee spending in the calendar year two years prior.
3.
Income growth is measured by GDP per capita for the preceding
calendar year to the GDP per capita for the calendar year two years
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%).
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.
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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
exemption due to health insurance options not being “affordable.”
2.
In 2014, the “affordability percentage” was defined as spending
more than 8% of household income.
3.
For 2015, IRS estimates the adjusted “affordability percentage” to be
8.05%.
[NOTE: CMS-9944-P identifies some of the applicable percentages for 2016.]
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
http://www.gpo.gov/fdsys/pkg/FR-2014-1202/pdf/2014-28398.pdf
Roster key:
Released:
12/2/2014
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).
Review.
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 28 of 41
2015-01-23
Roster of Pending Health-related Federal Regulations
– as of 1/26/2015
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
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.
1/5/2015: See analysis to
the left comparing tribal
recommendations and the
final rule issued by CMS.
Analysis:
NIHB submitted comments on the proposed version of this rule on February
17, 2012. A summary of the recommendations from NIHB, as well as the
responses from CMS in this final rule, appears below.
1.
Tribal Consultation: CMS did not engage in tribal consultation on the
proposed rule as required; CMS should engage in consultation with
AI/ANs prior to issuing the final rule.
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.
Roster key:
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.
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 41
2015-01-23
Roster of Pending Health-related Federal Regulations
– as of 1/26/2015
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
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 service-
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 30 of 41
2015-01-23
Roster of Pending Health-related Federal Regulations
– as of 1/26/2015
Additional Requirements for Charitable
Hospitals
TD 9708
Additional Requirements for Charitable
Hospitals; Community Health Needs
Assessments for Charitable Hospitals;
Requirement of a Section 4959 Excise Tax
Return and Time for Filing the Return
http://www.gpo.gov/fdsys/pkg/FR-2014-1231/pdf/2014-30525.pdf
Released:
12/31/2014
Due date:
None
specific 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]
This document contains final regulations that provide guidance regarding the
requirements for charitable hospital organizations added by ACA. These final
regulations will affect charitable hospital organizations.
These final regulations provide guidance on the requirements described in
section 501(r), the entities that must meet these requirements, and the
reporting obligations relating to these requirements under section 6033. In
addition, the final regulations provide guidance on the consequences
described in sections 501(r)(1), 501(r)(2)(B), and 4959 for failing to satisfy the
section 501(r) requirements.
1/7/2015: See analysis to
the left comparing the tribal
recommendation and the
final rule issued by IRS.
Analysis:
This rule finalizes REG-130266-11, issued on June 26, 2012, and REG-10649912, issued on April 5, 2013.
ANTHC submitted comments on REG-130266-11 on September 24, 2012. A
summary of the recommendation from ANTHC, as well as the response from
IRS in this final rule, appears below.
Hospitals Operated by Tribes: The proposed rule should expressly clarify that
hospitals operated by tribes or tribal organizations, even as part of a 501(c)(3)
organization, are exempt from its application to avoid ambiguity on this issue.
Based on its definitions of “hospital facility” and “hospital organization,” the
rule applies solely to entities recognized or seeking to be recognized as tax
exempt under 26 U.S.C. § 501(c)(3) that operate a facility required by a state
to be licensed, registered, or similarly recognized as a hospital. No states have
asserted their authority to require a license of a tribal hospital facility, and
the Indian Self-Determination and Education Assistance Act of 1975 and
subsequent amendments, as well as the Indian Health Care Improvement Act,
pre-empt any state authority in this area.
Response: Not addressed this rule; accepted in other rule.
Roster key:
Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of
interest to Tribes; struck-through are lowest priority.
Page 31 of 41
2015-01-23
Roster of Pending Health-related Federal Regulations
– as of 1/26/2015
Determining Mental Health Professional
Shortage Areas of Greatest Need
HRSA (no reference number)
Determining Mental Health Professional
Shortage Areas of Greatest Need
Released:
1/14/2015
Due date:
None
http://www.gpo.gov/fdsys/pkg/FR-2015-0114/pdf/2015-00398.pdf
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]
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.
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
Roster key:
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.
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 41
2015-01-23
Roster of Pending Health-related Federal Regulations
– as of 1/26/2015
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
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.”
2016 Actuarial Value Calculator
Methodology
CCIIO (no reference number)
Final 2016 Actuarial Value Calculator
Methodology
http://www.cms.gov/CCIIO/Resources/Regul
ations-and-Guidance/Downloads/Final-2016AV-Calculator-Methodology.pdf
Released:
1/16/2015
Due date:
None
Under the Essential Health Benefits, Actuarial Value, and Accreditation final
rule (EHB Final Rule) published in the February 25, 2013, Federal Register (78
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
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 41
2015-01-23
Roster of Pending Health-related Federal Regulations
– as of 1/26/2015
Annual Update of the HHS Poverty
Guidelines
HHS (no reference number)
Annual Update of the HHS Poverty
Guidelines
Released:
1/22/2015
Due date:
None
http://www.gpo.gov/fdsys/pkg/FR-2015-0122/pdf/2015-01120.pdf
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.
This notice provides an update of the HHS poverty guidelines to account for
the increase in prices as measured by the Consumer Price Index for the last
calendar year.
A table comparing the 2015 HHS poverty guidelines with the 2014 guidelines
is embedded below.
HHS Poverty
Guidelines 2014-2015 Table.docx
TSGAC Handout attached.
TSGAC Revised- 2015
FPL Handout - Medicaid and Marketplace 2015-01-23a.pdf
Medicare Secondary Payer and “Future
Medicals” (CMS-6047-P)
Received at
OMB:
8/1/2013
Influenza Vaccination Standard for Certain
Participating Providers and Suppliers (CMS-
Received at
OMB:
Roster key:
1/22/2015: No response
required/requested.
These poverty level figures
will be used for Medicaid
eligibility determinations for
the remainder of 2015 and
until revised FPL guidelines
are issued in 2016. (The
Marketplace will continue to
use the 2014 FPL guidelines
for 2015 QHP enrollment.)
Handout on use of 2015 FPL
linked to the left.
HEALTH-RELATED AGENCY ACTIONS PENDING AT OMB
This proposed rule would announce the intentions of CMS regarding means
beneficiaries or their representatives can use to protect Medicare with
respect to Medicare Secondary Payer (MSP) claims involving automobile and
liability insurance (including self-insurance), no-fault insurance, and workers’
compensation where future medical care is claimed or the settlement,
judgment, award, or other payment releases (or has the effect of releasing)
claims for future medical care.
Approved by OMB on 10/9/2014 but not yet released by the agency.
This final rule requires certain Medicare and Medicaid providers and
suppliers to offer all patients an annual influenza vaccination, unless
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 41
2015-01-23
Roster of Pending Health-related Federal Regulations
– as of 1/26/2015
3213-F)
9/27/2013
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.
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)
Received at
OMB:
9/18/2014
Received at
OMB:
9/18/2014
No detail provided.
Contract Year 2015 Policy and Technical
Changes to the Medicare Advantage and the
Medicare Prescription Drug Benefit Programs; Remaining Provisions (CMS-4159-F2)
Electronic Health Record (EHR) Incentive
Programs--Stage 3 (CMS-3310-P)
Received at
OMB:
11/20/2014
This final rule sets forth programmatic and operational changes to the
Medicare Advantage (MA) and prescription drug benefit programs for CY
2015.
Received at
OMB:
12/31/2014
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.
2015 Edition Health Information Technology
(Health IT) Certification Criteria, Base
Electronic Health Record (EHR) Definition,
and ONC Health IT Certification Program
Modifications
Received at
OMB:
12/31/2014
Roster key:
1/21/2015: NIHB technical
experts will be asked if they
have suggested comments.
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
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 41
2015-01-23
Roster of Pending Health-related Federal Regulations
– as of 1/26/2015
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)
DoL and IRS/Treasury
Health Insurance Premium Assistance Trust
Supporting the Purchase of Certain
Individual Health Insurance Policies-Exclusion from Definition of Employee
Welfare Benefit Plan (DoL RIN 1210-AB57)
Family and Medical Leave Act of 1993, as
Amended (DoL RIN 1235-AA09)
Received at
OMB:
1/7/2015
Received at
OMB:
1/17/2015
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.
Received at
OMB:
8/24/2013
No detail provided.
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
http://www.gpo.gov/fdsys/pkg/FR-2014-1003/pdf/2014-23182.pdf
Roster key:
Released:
10/3/2014
Due date:
12/2/2014
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.
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
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 41
2015-01-23
A summary of the major provisions of this proposed rule appears below.
Roster of Pending Health-related Federal Regulations
– as of 1/26/2015
Potential Revisions to Criteria for
Permissive Exclusion Authority
OIG-1271-N
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
Released:
7/11/2014
Due date:
9/9/2014
12/29/2014
[NOTE: No
content
changes
were made
when the
date was
extended.]
Anti-Kickback Statute and Safe Harbors
below).
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.
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)).
This notice informs the public that HHS OIG: (1) will consider revising the
Non-Binding Criteria for Implementing Permissive Exclusion Authority Under
Section 1128(b)(7) of the Social Security Act (Act); and (2) seeks input from
the public to consider in developing the revised criteria. Section 1128(b)(7) of
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
Roster key:
7/11/2014: Comments may
be warranted to advise
HHS/OIG on how the
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
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 41
2015-01-23
Roster of Pending Health-related Federal Regulations
– as of 1/26/2015
defendant.
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
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.
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.
submitted by TTAG.
2014-09-08 Final
TTAG Comments on OIG-1271-N - Permissive
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
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
1/12/2015: Comments filed
by TTAG and TSGAC.
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.
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http://www.cms.gov/CCIIO/Resources/Regul
ations-andGuidance/Downloads/2016DraftLettertoIssu
ers12-19-2014.pdf
otherwise specified, references to the FFMs include the FF-SHOPs.
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
Parameters for 2016” (2016 Payment Notice proposed rule), CMS-9944-P,
published on November 26, 2014.
TTAG Comments on
CCIIO Issuer Letter.pdf
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
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.
Establish standards for the creation and maintenance of networks by
health carriers; and
1/7/2015: An analysis from
Mim Dixon with suggested
comments is embedded
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.
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Adequacy Model Act (Draft)
2.
http://www.naic.org/documents/committee
s_b_rftf_namr_sg_exposure_draft_proposed
_revisions_mcpna_model_act.pdf
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.
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.
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
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.
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).
below.
NAIC Model Act
Comments, 1-7-15.docx
1/12/2015: TTAG submitted
comments.
TTAG NAIC Network
Adequacy Model Act Comment.pdf
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
Roster key:
1/13/2015: Draft comments
are embedded below.
DELETED.
1/14/2015: 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.
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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
available for beneficiaries under both health care systems.
on NIHB and TSGAC
letterhead.
TSGAC Ltr to Tracy
Parker Warren- OPIA-VA re Comments VA Agr
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.
2.
Roster key:
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
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.
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.
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