Upcoming Rules Pursuant to the Patient Protection and Affordable Care Act: The Fall 2013 Unified Agenda
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Upcoming Rules Pursuant to the Patient
Protection and Affordable Care Act: The Fall
2013 Unified Agenda
Maeve P. Carey
Analyst in Government Organization and Management
Michelle D. Christensen
Analyst in Government Organization and Management
February 4, 2014
Congressional Research Service
7-5700
www.crs.gov
R43386
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Upcoming Rules Pursuant to the Patient Protection and Affordable Care Act
Summary
The Patient Protection and Affordable Care Act (ACA, as amended) was signed into law by
President Barack Obama on March 23, 2010. As is often the case with legislation, the ACA
granted rulemaking authority to federal agencies to implement many of its provisions. The
regulations issued pursuant to the ACA and other statutes carry the force and effect of law.
Therefore, scholars and practitioners have long noted the importance of rulemaking to the policy
process, as well as the importance of congressional oversight of rulemaking. For example, one
scholar noted that the “Constitution’s grant of legislative power to Congress encompasses a
responsibility to ensure that delegated authority is exercised according to appropriate
procedures.” Congressional oversight of rulemaking can deal with a variety of issues, including
the substance of the rules issued pursuant to congressional delegations of authority and the
process by which those rules are issued.
Having a sense of what rules agencies are going to issue and when they are going to issue those
rules can help Congress conduct oversight over the regulations that are issued pursuant to the
ACA. One way in which Congress can identify upcoming ACA rules is by reviewing the Unified
Agenda of Federal Regulatory and Deregulatory Actions (hereinafter, Unified Agenda), which is
published by the Regulatory Information Service Center (RISC), a component of the U.S. General
Services Administration (GSA), for the Office of Management and Budget’s (OMB’s) Office of
Information and Regulatory Affairs (OIRA). The Unified Agenda lists upcoming activities, by
agency, in three separate categories:
• “active” actions, including rules in the prerule stage (e.g., advance notices of
proposed rulemaking that are expected to be issued in the next 12 months);
proposed rule stage (i.e., notices of proposed rulemaking that are expected to be
issued in the next 12 months, or for which the closing date of the comment period
is the next step); and final rule stage (i.e., final rules or other final actions that are
expected to be issued in the next 12 months);
• “completed” actions (i.e., final rules or rules that have been withdrawn since the
last edition of the Unified Agenda); and
• “long-term” actions (i.e., items under development that agencies do not expect to
take action on in the next 12 months).
All entries in the Unified Agenda usually provide uniform data elements, which typically include
the department and agency issuing the rule, the title of the rule, the Regulation Identifier Number
(RIN), an abstract describing the nature of the action being taken, and a timetable showing the
dates of past actions and a projected date for the next regulatory action. Each entry also indicates
the priority of the regulation (e.g., whether it is considered “economically significant” under
Executive Order 12866, or whether it is considered a “major” rule under the Congressional
Review Act).
The most recent edition of the Unified Agenda, which was published on November 26, 2013, is
the sixth edition of the agenda since enactment of ACA. In this edition, agencies reported 19
proposed rules and 20 final rules that they expect to issue pursuant to ACA within the next 12
months. Agencies also reported a total of 12 long-term regulatory actions.
The Appendix of this report lists the upcoming proposed and final rules published in the Fall
2013 Unified Agenda in a table.
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Contents
Introduction ...................................................................................................................................... 1
Mandatory and Discretionary Rulemaking Provisions .............................................................. 1
Congressional Oversight and the Unified Agenda..................................................................... 2
The Unified Agenda ............................................................................................................ 2
Scope and Methodology of This Report .................................................................................... 4
Upcoming ACA Proposed Rules ...................................................................................................... 5
Notable Proposed Rules ............................................................................................................ 5
Rules Included in the Regulatory Plan ................................................................................ 5
“Economically Significant” or “Major” Proposed Rules .................................................... 5
“Other Significant” Proposed Rules .................................................................................... 6
Effects on Small Entities ..................................................................................................... 7
Timing of the Proposed Rules ................................................................................................... 7
Upcoming ACA Final Rules ............................................................................................................ 9
Notable Final Rules ................................................................................................................... 9
Rules Included in the Regulatory Plan ................................................................................ 9
“Economically Significant” or “Major” Final Rules ......................................................... 10
“Other Significant” Final Rules ........................................................................................ 10
Effects on Small Entities ................................................................................................... 11
Timing of Final Rules .............................................................................................................. 11
ACA Long-Term Actions ............................................................................................................... 12
Notable Long-Term Actions .................................................................................................... 13
Congressional Oversight Options .................................................................................................. 14
Appendixes
Appendix. Upcoming Proposed and Final Rules Pursuant to the Patient Protection and
Affordable Care Act .................................................................................................................... 16
Contacts
Author Contact Information........................................................................................................... 26
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Introduction
Federal regulations generally result from an act of Congress and are one significant means by
which statutes are implemented. Congress delegates rulemaking authority to agencies for a
variety of reasons, and in a variety of ways. The Patient Protection and Affordable Care Act
(ACA, as amended) provides a notable example of congressional delegation of rulemaking
authority to federal agencies.1 A previous CRS report identified more than 40 provisions in the
ACA that explicitly require or permit the issuance of rules to implement the law.2
The rules that agencies have issued, and will continue to issue, pursuant to the ACA have a major
impact on how the law is implemented. For example, in an article entitled “The War Isn’t Over,”
posted on the New England Journal of Medicine’s Health Care Reform Center shortly after the
ACA was signed into law, Henry J. Aaron and Robert D. Reischauer wrote,
Making the legislation a success requires not only that it survive but also that it be effectively
implemented. Although the bill runs to more than 2000 pages, much remains to be decided.
The legislation tasks federal or state officials with writing regulations, making appointments,
and giving precise meaning to many terms.3
Mandatory and Discretionary Rulemaking Provisions
The manner in which Congress delegates rulemaking authority to federal agencies determines the
amount of discretion the agencies have in crafting the rules and, conversely, the amount of control
that Congress retains for itself. Some of the more than 40 rulemaking provisions in the ACA are
quite specific, stipulating the substance of the rules, whether certain consultative or rulemaking
procedures should be used, and deadlines for their issuance or implementation.4 Other provisions
in the ACA permit, but do not require, the agencies to issue certain rules (e.g., stating that the
head of an agency “may issue regulations” defining certain terms, or “may by regulation”
establish guidance or requirements for carrying out the legislation). As a result, the agency head
has the discretion to decide whether to issue any regulations at all, and if so, what those rules will
contain. Still other provisions in the ACA require agencies to establish programs or procedures
but do not specifically mention regulations.
1 The ACA was signed into law on March 23, 2010 (P.L. 111-148, 124 Stat. 119). On March 30, 2010, the President
signed the Health Care and Education Reconciliation Act (HCERA; P.L. 111-152, 124 Stat. 1029), which amended
multiple health care and revenue provisions in the ACA. Several other subsequently enacted bills made more targeted
changes to specific ACA provisions. All references to the ACA in this report refer to the law as amended. For more
information on the ACA, see CRS Report R41664, ACA: A Brief Overview of the Law, Implementation, and Legal
Challenges, coordinated by C. Stephen Redhead.
2 CRS Report R41180, Rulemaking Requirements and Authorities in the Patient Protection and Affordable Care Act
(PPACA), by Curtis W. Copeland. The author of that report has retired from CRS; questions about its content may be
directed to the authors of this report.
3 Henry J. Aaron and Robert D. Reischauer, “The War Isn’t Over,” New England Journal of Medicine, Health Care
Reform Center, March 24, 2010, at http://healthcarereform.nejm.org/?p=3223&query=home.
4 Although the law contains a number of deadlines for the issuance of rules, rulemaking deadlines are generally
somewhat difficult to enforce, unless the statute itself contains an enforcement mechanism. None of the provisions in
ACA contains a legislative enforcement mechanism. One potential option for enforcement is civil litigation, although
courts often defer to agencies’ judgment on the timing of their issuance of a rule.
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Congressional Oversight and the Unified Agenda
In his book Building a Legislative-Centered Public Administration, David H. Rosenbloom noted
that rulemaking and lawmaking are functionally equivalent (the results of both processes have the
force of law), and that when agencies issue rules they, in effect, legislate. He went on to say that
the “Constitution’s grant of legislative power to Congress encompasses a responsibility to ensure
that delegated authority is exercised according to appropriate procedures.”5 Congressional
oversight of rulemaking can deal with a variety of issues, including the substance of the rules
issued pursuant to congressional delegations of authority and the process by which those rules are
issued.6
Having an early sense of what rules agencies are going to issue, and when they are going to issue
those rules, can help Congress conduct oversight over the regulations that are issued pursuant to
ACA. The previously referenced CRS report identifying the provisions in the act that require or
permit rulemaking can be useful in this regard.7 The law does not, however, indicate when some
of the mandatory rules should be issued.
The Unified Agenda
A potentially effective way for Congress to identify upcoming ACA rules is by reviewing the
Unified Agenda, which is usually published twice each year—in the spring and fall.8 The Unified
Agenda is published by the Regulatory Information Service Center (RISC), a component of the
General Services Administration (GSA), for the Office of Management and Budget’s (OMB’s)
Office of Information and Regulatory Affairs (OIRA).9 The Unified Agenda helps agencies fulfill
two current transparency requirements:
• The Regulatory Flexibility Act (5 U.S.C. §602) requires that all agencies publish
semiannual regulatory agendas in the Federal Register, in April and October of
each year, describing regulatory actions that they are developing that may have a
significant economic impact on a substantial number of small entities.10
• Section 4 of Executive Order 12866 on “Regulatory Planning and Review”
requires that all executive branch agencies “prepare an agenda of all regulations
under development or review.”11 The stated purposes of this and other planning
5 David H. Rosenbloom, Building a Legislative-Centered Public Administration: Congress and the Administrative
State, 1946-1999 (Tuscaloosa, AL: University of Alabama Press, 2000), pp. 133-134.
6 For a discussion of Congress’s broad oversight authority, see CRS Report RL30240, Congressional Oversight
Manual, by Todd Garvey et al.
7 CRS Report R41180, Rulemaking Requirements and Authorities in the Patient Protection and Affordable Care Act
(PPACA), by Curtis W. Copeland. The author of that report has retired from CRS; questions about its content may be
directed to the authors of this report.
8 To comply with the requirements of the Regulatory Flexibility Act (5 U.S.C. §602) and Executive Order 12866, the
Unified Agenda is usually published twice annually—in the spring and fall. The 2012 Unified Agenda, however, was
published as a single edition on December 21, 2012.
9 The current edition of the Unified Agenda, which was published on November 26, 2013, is available at
http://www.reginfo.gov/public/do/eAgendaMain.
10 This requirement applies to all agencies covered by the Administrative Procedure Act (5 U.S.C. §551(1)).
11 Executive Order 12866, “Regulatory Planning and Review,” 58 Federal Register 51735, October 4, 1993. Although
most of the requirements in this executive order do not apply to independent regulatory agencies (e.g., the Securities
(continued...)
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requirements in the order are, among other things, to “maximize consultation and
the resolution of potential conflicts at an early stage” and to “involve the public
and its State, local, and tribal officials in regulatory planning.” The executive
order also requires that each agency prepare, as part of the fall edition of the
Unified Agenda, a “regulatory plan” of the most important significant regulatory
actions that the agency reasonably expects to issue in proposed or final form
during the upcoming fiscal year.
The Unified Agenda lists upcoming activities, by agency, in three separate categories:
• “active” actions, including rules in the prerule stage (e.g., advance notices of
proposed rulemaking that are expected to be issued in the next 12 months);
proposed rule stage (i.e., notices of proposed rulemaking that are expected to be
issued in the next 12 months, or for which the closing date of the comment period
is the next step); and final rule stage (i.e., final rules or other final actions that are
expected to be issued in the next 12 months);
• “completed” actions (i.e., final rules or rules that have been withdrawn since the
last edition of the Unified Agenda); and
• “long-term” actions (i.e., items under development that agencies do not expect to
take action on in the next 12 months).
All entries in the Unified Agenda usually have uniform data elements, which typically include the
department and agency issuing the rule, the title of the rule, the Regulation Identifier Number
(RIN),12 an abstract describing the nature of action being taken, and a timetable showing the dates
of past actions and a projected date (sometimes just the projected month and year) for the next
regulatory action. Each entry also contains an element indicating the priority of the regulation
(e.g., whether it is considered “economically significant” under Executive Order 12866, or
whether it is considered a “major” rule under the Congressional Review Act).13
There is no penalty for issuing a rule without a prior notice in the Unified Agenda, and some
prospective rules listed in the Unified Agenda are never issued, reflecting the fluid nature of the
rulemaking process. Nevertheless, the Unified Agenda can help Congress and the public know
what regulatory actions are about to occur, and, arguably, it provides federal agencies with the
(...continued)
and Exchange Commission and Federal Reserve Board), this section of the order does include those agencies.
12 RINs are assigned by RISC, and the Office of Management and Budget has asked agencies to include RINs in the
headings of their rulemaking documents when they are published in the Federal Register to make it easier for the
public and agency officials to track the publication history of regulatory actions. For a copy of this memorandum, see
http://www.whitehouse.gov/sites/default/files/omb/assets/inforeg/IncreasingOpenness_04072010.pdf.
13 Section 3(f) of Executive Order 12866 defines a “significant” regulatory action as one that is likely to result in a rule
that may: “(1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the
economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State,
local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action
taken or planned by another agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan
programs or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal
mandates, the President’s priorities, or the principles set forth in this Executive order.” Regulatory actions meeting the
first of these four criteria are considered “economically significant.” The definition of a “major” rule under the
Congressional Review Act (5 U.S.C. §§801-808) is similar to the definition of “economically significant,” since both
definitions are triggered if a rule has, among other things, a $100 million effect on the economy.
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most systematic, government-wide method to alert the public about their upcoming proposed
rules.14
Scope and Methodology of This Report
The Fall 2013 edition of the Unified Agenda, published on November 26, 2013, is the sixth
edition compiled and issued by RISC since enactment of the ACA.15 Federal agencies were
required to submit data to RISC for the Unified Agenda by August 29, 2013, but some items may
have been subsequently updated during the OIRA review process.16
This report examines the Fall 2013 edition of the Unified Agenda and identifies upcoming
proposed and final rules and long-term regulatory actions expected to be issued pursuant to the
ACA in the next 12 months. To identify those upcoming rules and actions, CRS searched all
fields of the Unified Agenda (all agencies) using the term “Affordable Care Act,” focusing on the
proposed rule and final rule stages of rulemaking, as well as the “long-term actions” category.
In this edition, agencies reported 19 proposed rules and 20 final rules they expect to issue
pursuant to the ACA within the next 12 months. Agencies also reported a total of 12 long-term
regulatory actions.
The results of the search for proposed and final rules are provided in the Appendix to this report.
For each upcoming proposed and final rule listed, the table identifies the department and agency
expected to issue the rule, the title of the rule and its RIN, an abstract describing the nature of the
rulemaking action, and the date the proposed or final rule is expected to be issued.17 The abstracts
presented in the table were taken verbatim from the Unified Agenda entries. Within the proposed
and final rule sections of the table, the entries are organized by agency.18
14 A previously issued CRS report indicated that about three-fourths of the significant proposed rules published after
having been reviewed by OIRA in 2008 were previously listed in the proposed rule section of the Unified Agenda. CRS
Report R40713, The Unified Agenda: Implications for Rulemaking Transparency and Participation, by Curtis W.
Copeland. The author of that report has retired from CRS; questions about its content may be directed to the authors of
this report.
15 Following the ACA’s enactment in March 2010, the first edition of the Unified Agenda containing regulations that
were to be issued pursuant to the ACA was issued on December 20, 2010.
16 Memorandum from Howard Shelanski, Administrator of the Office of Information and Regulatory Affairs,
“Memorandum for Regulatory Policy Officers at Executive Departments and Agencies & Managing and Executive
Directors of Certain Agencies and Commissions,” August 7, 2013, at http://www.whitehouse.gov/sites/default/files/
omb/inforeg/memos/fall-2013-regulatory-plan-and-agenda.pdf. A previous e-mail from John C. Thomas, RISC
Executive Director, August 3, 2011, to CRS indicated that Unified Agenda items are sometimes updated during the
OIRA review process.
17 In addition to the RINs, CMS included an agency-specific number as part of the title of the rule (e.g., CMS-2327-F).
Those numbers are included as part of the title in the table in the Appendix.
18 It should be emphasized that the proposed and final rules and long-term actions identified in the Unified Agenda and
summarized in this report may not represent all the ACA-related rulemaking activity within HHS and other federal
agencies. In particular, the ACA made numerous changes to existing Medicare payment systems, either permanently or
on a temporary basis, and required coverage of new Medicare benefits. In most cases, the Centers for Medicare &
Medicaid Services (CMS) has opted to address these changes in its annual rulemaking updates for the various Medicare
payment systems. For example, the annual final rules updating Medicare payment policies and rates for physician
services and for hospital inpatient services both include multiple sets of provisions to incorporate and implement ACA
mandates. These rules and similar annual updates may not be discussed in this report if agencies did not submit them as
part of the Unified Agenda.
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Upcoming ACA Proposed Rules
The Fall 2013 edition of the Unified Agenda listed 19 ACA-related rules in the “proposed rule
stage” (indicating that the agencies expected to issue proposed rules on the topics within the next
12 months, or for which the closing dates of the comment periods are the next step).19 Twelve of
the 19 upcoming proposed rules were expected to be issued by components of the Department of
Health and Human Services (HHS): Centers for Medicare & Medicaid Services (CMS, seven
rules), the Office of Inspector General (OIG, three rules), the Health Resources and Services
Administration (HRSA, one rule), and the Office for Civil Rights (OCR, one rule). Other
proposed rules were expected to be issued by the Treasury Department’s Internal Revenue
Service (TREAS/IRS, four rules) and the Office of Personnel Management (OPM, two rules).
The final upcoming proposed rule is expected to be issued by the Department of Labor’s
Employee Benefits Security Administration (DOL/EBSA).
Notable Proposed Rules
Rules agencies intend to issue pursuant to the ACA may be considered notable for a variety of
reasons—for example, they may be considered notable if they are listed in the agency’s
“regulatory plan,” which is described below, or if they meet a particular statutory or executive
order definition of significance. Some examples of notable rules are listed below.
Rules Included in the Regulatory Plan
As stated earlier, Executive Order 12866 requires that each agency prepare, as part of the fall
edition of the Unified Agenda, a regulatory plan detailing the most important regulatory actions
the agency reasonably expects to issue in proposed or final form during the upcoming fiscal year.
HHS considered one of the items in the proposed rule section of the Unified Agenda important
enough to be included in its regulatory plan: a rule pertaining to “Eligibility, Enrollment, and
Appeals Updates” (expected to be issued in February 2014).
“Economically Significant” or “Major” Proposed Rules
In addition to the ACA-related proposed rule that was listed in the regulatory plan, the Unified
Agenda listed three other rules that CMS considered “economically significant” and “major” (one
definition of “economically significant” or “major,” for example, is that the rule is expected to
have at least a $100 million annual effect on the economy).20 The three CMS rules are
• a rule on “Prospective Payment System for Federally Qualified Health Centers;
Changes to Contracting Policies for Rural Health Clinics and CLIA Enforcement
19 The number of actions listed in the Unified Agenda and reported here may not necessarily be precisely equivalent to
the number of upcoming proposed rules. For example, in a case in which two agencies are working on a joint rule, it is
possible they would each report it separately to the Unified Agenda, and such a rule would appear as two actions. None
of the rules listed in the Unified Agenda indicated that they are joint rules, however, so that is unlikely in this case. (As
explained below, two of the rules listed in the “final rule stage” are actually a single joint rule.)
20 For definitions and a more complete discussion of different types of rules, see CRS Report R43056, Counting
Regulations: An Overview of Rulemaking, Types of Federal Regulations, and Pages in the Federal Register, by Maeve
P. Carey.
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Actions for Proficiency Testing Referral,” which CMS published as a proposed
rule on September 23, 2013, and expects to publish as a final rule in August
2014;21
• a rule on “CY 2015 Notice of Benefit and Payment Parameters,” which CMS
published as a proposed rule on December 2, 2013;22 and
• a rule on “Establishment of the Basic Health Program,” which the agency
published as a proposed rule on September 25, 2013, and expects to publish as a
final rule in March 2014.23
“Other Significant” Proposed Rules
In addition to the above-mentioned rules, the agencies characterized 6 of the 19 upcoming
proposed rules as “other significant,” indicating that although they were not listed in the
regulatory plan or expected to be “economically significant,” they were expected to be significant
enough to be reviewed by OIRA under Executive Order 12866.24 The “other significant”
proposed rules are
• an HHS/CMS rule on “Administrative Simplification: Compliance: Health Plan
Certification,” which CMS published as a proposed rule on January 2, 2014;25
• an HHS/CMS rule on “Reform of Requirements for Long-Term Care Facilities
and Quality Assurance and Performance Improvement (QAPI) Program,” which
the agency expects to publish sometime in March 2014;
• an HHS/CMS rule on “Establishment of Quality Standards for Exchanges and
Qualified Health Plans (QHPs),” which the agency expects to publish sometime
in March 2014;
• an HHS/CMS rule on “Eligibility, Enrollment, and Appeals Updates,” which the
agency expects to publish sometime in February 2014;
21 U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services, “Medicare Program;
Prospective Payment System for Federally Qualified Health Centers; Changes to Contracting Policies for Rural Health
Clinics; and Changes to Clinical Laboratory Improvement Amendments of 1988 Enforcement Actions for Proficiency
Testing Referral,” 78 Federal Register 58386, September 23, 2013.
22 U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services, “Patient Protection and
Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2015,” 78 Federal Register 72322,
December 2, 2013.
23 U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services, “Basic Health Program:
State Administration of Basic Health Programs; Eligibility and Enrollment in Standard Health Plans; Essential Health
Benefits in Standard Health Plans; Performance Standards for Basic Health Programs; Premium and Cost Sharing for
Basic Health Programs; Federal Funding Process; Trust Fund and Financial Integrity,” 78 Federal Register 59122,
September 25, 2013.
24 Executive Order 12866 requires covered agencies (all except independent regulatory agencies like the Securities and
Exchange Commission) to submit their “significant” rules to OIRA for review before publication as a proposed or final
rule. For more information, see CRS Report RL32397, Federal Rulemaking: The Role of the Office of Information and
Regulatory Affairs, coordinated by Maeve P. Carey.
25 U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services, “Administrative
Simplification: Certification of Compliance for Health Plans; Proposed Rule,” 79 Federal Register 297, January 2,
2014.
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• an HHS/OCR rule on “Nondiscrimination Under the Patient Protection and
Affordable Care Act,” which the agency expects to publish sometime in August
2014; and
• a DOL/EBSA rule on “Amendments to Excepted Benefits,” which the agency
published as a proposed rule on December 24, 2013.26
Effects on Small Entities
The Regulatory Flexibility Act (5 U.S.C. §602) generally requires federal agencies to assess the
impact of their forthcoming regulations on “small entities” (i.e., small businesses, local
governments, and small not-for-profit organizations).27 Five of the ACA-related rules listed in the
proposed rule section were expected to trigger the requirements of the Regulatory Flexibility Act
because of their effects on small entities.
Two of the upcoming proposed rules were expected to trigger the requirements of the Regulatory
Flexibility Act because of their effects on small businesses:
• an HHS/CMS rule on “Administrative Simplification: Compliance: Health Plan
Certification”; and
• an HHS/CMS rule on “Reform of Requirements for Long-Term Care Facilities
and Quality Assurance and Performance Improvement (QAPI) Program.”
Two of the upcoming proposed rules were expected to trigger the requirements of the Regulatory
Flexibility Act because of their effects on small businesses and local governments:
• an HHS/CMS rule on “CY 2015 Notice of Benefit and Payment Parameters”; and
• an HHS/CMS rule on “Eligibility, Enrollment, and Appeals Updates.”
The HHS/CMS rule on “Establishment of Quality Standards for Exchanges and Qualified Health
Plans (QHPs)” is also expected to have an effect on small businesses, local governments, and not-
for-profit organizations, another potential trigger for the Regulatory Flexibility Act’s analysis
requirement.
Timing of the Proposed Rules
As of January 23, 2014, nine items in the proposed rule section of the Unified Agenda had been
published in the Federal Register as a proposed rule. The rules for which proposed rules have
been published are
26 U.S. Department of the Treasury, Internal Revenue Service; U.S. Department of Labor, Employee Benefits Security
Administration; and U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services,
“Amendments to Excepted Benefits,” 79 Federal Register 77632. Although this proposed rule was published jointly by
TREAS/IRS, DOL/EBSA, and HHS/CMS, only DOL/EBSA listed it in the Unified Agenda.
27 For more information, see CRS Report RL32240, The Federal Rulemaking Process: An Overview, coordinated by
Maeve P. Carey.
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• an HHS/CMS rule on “Prospective Payment System for Federally Qualified
Health Centers; Changes to Contracting Policies for Rural Health Clinics and
CLIA Enforcement Actions for Proficiency Testing Referral”;28
• an HHS/CMS rule on “CY 2015 Notice of Benefit and Payment Parameters”;29
• an HHS/CMS rule on “Establishment of the Basic Health Program”;30
• an HHS/CMS rule on “Administrative Simplification: Compliance: Health Plan
Certification”;31
• a DOL/EBSA rule on “Amendments to Excepted Benefits”;32
• a TREAS/IRS rule on “Fees on Health Insurance and Self-Insured Plans”;33
• a TREAS/IRS rule on “Reporting and Notice Requirements Under Section
6056”;34
• a TREAS/IRS rule on “Tax Credit for Employee Health Insurance Expenses of
Small Employers”;35 and
• a TREAS/IRS rule on “Requirement of a Section 4959 Excise Tax Return and
Time for Filing the Return.”36
28 U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services, “Medicare Program;
Prospective Payment System for Federally Qualified Health Centers; Changes to Contracting Policies for Rural Health
Clinics; and Changes to Clinical Laboratory Improvement Amendments of 1988 Enforcement Actions for Proficiency
Testing Referral,” 78 Federal Register 58386, September 23, 2013.
29 U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services, “Patient Protection and
Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2015,” 78 Federal Register 72322,
December 2, 2013.
30 U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services, “Basic Health Program:
State Administration of Basic Health Programs; Eligibility and Enrollment in Standard Health Plans; Essential Health
Benefits in Standard Health Plans; Performance Standards for Basic Health Programs; Premium and Cost Sharing for
Basic Health Programs; Federal Funding Process; Trust Fund and Financial Integrity,” 78 Federal Register 59122,
September 25, 2013.
31 U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services, “Administrative
Simplification: Certification of Compliance for Health Plans; Proposed Rule,” 79 Federal Register 297, January 2,
2014.
32 U.S. Department of the Treasury, Internal Revenue Service; U.S. Department of Labor, Employee Benefits Security
Administration; and U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services,
“Amendments to Excepted Benefits,” 79 Federal Register 77632.
33 TREAS/IRS published this rule as an NPRM on April 17, 2012, and a final rule on December 6, 2012. It is unclear
why the rule is listed in the proposed rule section of the Fall 2013 Unified Agenda. See U.S. Department of the
Treasury, Internal Revenue Service, “Fees on Health Insurance Policies and Self-Insured Plans for the Patient-Centered
Outcomes Research Trust Fund,” 77 Federal Register 22691, April 17, 2012 (proposed rule); and U.S. Department of
the Treasury, Internal Revenue Service, “Fees on Health Insurance Policies and Self-Insured Plans for the Patient-
Centered Outcomes Research Trust Fund,” 77 Federal Register 72721, December 6, 2012 (final rule).
34 U.S. Department of the Treasury, Internal Revenue Service, “Information Reporting by Applicable Large Employers
on Health Insurance Coverage Offered Under Employer-Sponsored Plans,” 78 Federal Register 54996, September 9,
2013.
35 U.S. Department of the Treasury, Internal Revenue Service, “Tax Credit for Employee Health Insurance Expenses of
Small Employers,” 78 Federal Register 57219, August 26, 2013.
36 U.S. Department of the Treasury, Internal Revenue Service, “Requirement of a Section 4959 Excise Tax Return and
Time for Filing the Return,” 78 Federal Register 49700, August 15, 2013.
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Upcoming Rules Pursuant to the Patient Protection and Affordable Care Act
One proposed rule was expected to be published sometime during December 2013, but had not
been published as of January 23, 1014. That rule is an OPM rule on “Federal Employees’ Health
Benefits Program; Disputed Claims and External Review Requirements.”
Upcoming ACA Final Rules
The Fall 2013 edition of the Unified Agenda listed 20 upcoming rules in the final rule section
(indicating that the agencies expected to issue these final rules within the next 12 months).37 Eight
of the 20 upcoming final rules are expected to be issued by components of HHS: the Health
Resources and Services Administration (HRSA, one rule); the Food and Drug Administration
(FDA, two rules); CMS (four rules); and the Office of the Secretary (OS, one rule). Seven of the
20 upcoming final rules are expected to be issued by TREAS/IRS. Other final rules are expected
to be issued by DOL’s Occupational Safety and Health Administration (OSHA, one rule); the
Architectural and Transportation Barriers Compliance Board (ATBCB, one rule); the Office of
Personnel Management (OPM, one rule); and the Social Security Administration (SSA, one rule).
Finally, one rule will be issued jointly by DOL/EBSA, HHS/CMS, and TREAS/IRS.
Notable Final Rules
As mentioned above, rules may be notable for a variety of reasons; several examples of notable
upcoming final rules are listed in the section below.
Rules Included in the Regulatory Plan
Four of the ACA regulations that were listed in the final rule section of the Unified Agenda were
considered important enough to be included in the agencies’ regulatory plans:38
• two HHS/FDA rules on “Food Labeling: Calorie Labeling of Articles of Food
Sold in Vending Machines” and “Food Labeling: Nutrition Labeling of Standard
Menu Items in Restaurants and Similar Retail Food Establishments,” both of
which the agency expects to publish in February 2014;
• an ATBCB rule on “Accessibility Standards for Medical Diagnostic Equipment,”
which the agency expects to publish in September 2014; and
• an SSA rule on “Conforming Changes to Regulations Regarding Income-Related
Monthly Adjustment Amounts to Medicare Part B Premiums,” which the agency
37 The Unified Agenda reported 21 actions in the final rule category, but the 21 actions actually represent 20 rules. One
of the rules is a joint rule, and joint rules are listed once in the Unified Agenda by each participating agency. Both
HHS/CMS and DOL/EBSA submitted an entry for the joint rule on “Ninety-Day Waiting Period Limitation and
Technical Amendments to Certain Health Coverage Requirements Under the Affordable Care Act,” and therefore it is
listed twice in the final rules section of the Unified Agenda database. In this report, it is counted as only one rule. The
joint rule is listed at the end of the Appendix.
38 Executive Order 12866 requires that each agency prepare, as part of the fall edition of the Unified Agenda, a
“regulatory plan” of the most important significant regulatory actions that the agency reasonably expects to issue in
proposed or final form during the upcoming fiscal year.
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Upcoming Rules Pursuant to the Patient Protection and Affordable Care Act
published as an interim final rule with request for comments on September 18,
2013.39
“Economically Significant” or “Major” Final Rules
The Unified Agenda listed six entries in the final rule section that were considered “economically
significant” and “major” (i.e., that were expected to have at least a $100 million annual effect on
the economy). These six rules are
• two HHS/FDA rules on “Food Labeling: Calorie Labeling of Articles of Food
Sold in Vending Machines” and “Food Labeling: Nutrition Labeling of Standard
Menu Items in Restaurants and Similar Retail Food Establishments,” both of
which the agency expects to publish in February 2014;
• an HHS/CMS rule on “Home and Community-Based State Plan Services
Program, Waivers, and Provider Payment Reassignments,” which the agency
published as a final rule on January 16, 2014;40
• an HHS/CMS rule on “Face-to-Face Requirements for Home Health Services;
Policy Changes and Clarifications Related to Home Health,” which the agency
expects to publish in September 2014;
• an HHS/CMS rule on “Covered Outpatient Drugs,” which the agency expects to
publish in May 2014; and
• an HHS/CMS rule on “Adoption of Operating Rules for HIPAA Transactions,”
which the agency expects to publish in June 2014.
“Other Significant” Final Rules
In addition to the above-mentioned rules, seven other upcoming final rules listed in the Unified
Agenda were characterized as “other significant,” indicating that although they were not listed in
the regulatory plan or expected to be “economically significant,” they were expected to be
significant enough to be reviewed by OIRA under Executive Order 12866. These seven rules are
• an HHS/HRSA rule on “Designation of Medically Underserved Populations and
Health Professional Shortage Areas,” which the agency expects to publish as an
interim final rule in September 2014;
• an HHS/OS rule on “Health and Human Services Acquisition Regulation (HHS’
Supplement to the Federal Acquisition Regulation),” which the agency expects to
publish as an interim final rule in April 2014;
39 Social Security Administration, “Medicare Determinations and Income-Related Monthly Adjustment Amounts to
Medicare Part B Premiums; Conforming Changes to Regulations,” 78 Federal Register 57257, September 18, 2013.
40 U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services, “Medicaid Program;
State Plan Home and Community-Based Services, 5-Year Period for Waivers, Provider Payment Reassignment, and
Home and Community-Based Setting Requirements for Community First Choice and Home and Community-Based
Services (HCBS) Waivers; Final Rule,” 79 Federal Register 2947, January 16, 2014.
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• a DOL/OSHA rule on “Procedures for the Handling of Retaliation Complaints
Under Section 1558 of the Affordable Care Act of 2010,” which the agency
expects to publish in July 2014;
• an ATBCB rule on “ Accessibility Standards for Medical Diagnostic Equipment,”
which the agency expects to publish in September 2014;
• an OPM rule on “Federal Employees’ Health Benefits Program: Members of
Congress and Congressional Staff,” which the agency expects to publish as a
final rule in 2014;
• an SSA rule on “Conforming Changes to Regulations Regarding Income-Related
Monthly Adjustment Amounts to Medicare Part B Premiums,” which the agency
published as an interim final rule with request for comments on September 18,
2013;41 and
• an HHS/CMS and DOL/EBSA joint rule on “Ninety-Day Waiting Period
Limitation and Technical Amendments to Certain Health Coverage Requirements
Under the Affordable Care Act,” which HHS indicated would be published in
December 2013 and DOL/EBSA indicated would be published in February 2014
(the rule had not been published as of January 23, 2014).42
Effects on Small Entities
Two of the upcoming final rules were expected to trigger the requirements of the Regulatory
Flexibility Act (5 U.S.C. §602) because of their effects on small businesses:
• an HHS/CMS rule on “Home and Community-Based State Plan Services
Program, Waivers, and Provider Payment Reassignments”; and
• an HHS/CMS rule on “Ninety-Day Waiting Period Limitation and Technical
Amendments to Certain Health Coverage Requirements Under the Affordable
Care Act.” Although this rule will be issued jointly with DOL/EBSA,
DOL/EBSA did not indicate in its Unified Agenda entry that the requirements of
the Regulatory Flexibility Act would be triggered.
Timing of Final Rules
Five of the rules listed in the final rule section of the Unified Agenda had been published as of
January 23, 2014:
• an HHS/CMS rule on “Home and Community-Based State Plan Services
Program, Waivers, and Provider Payment Reassignments”;43
41 Social Security Administration, “Medicare Determinations and Income-Related Monthly Adjustment Amounts to
Medicare Part B Premiums; Conforming Changes to Regulations,” 78 Federal Register 57257, September 18, 2013.
42 This rule will also be issued jointly with TREAS/IRS, though TREAS/IRS included it in the “Long-Term Actions”
portion of the Unified Agenda and estimated it would be published in December 2014.
43 U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services, “Medicaid Program;
State Plan Home and Community-Based Services, 5-Year Period for Waivers, Provider Payment Reassignment, and
Home and Community-Based Setting Requirements for Community First Choice and Home and Community-Based
Services (HCBS) Waivers; Final Rule,” 79 Federal Register 2947, January 16, 2014.
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• a TREAS/IRS rule on “Medical Loss Ratio for Section 833 Organizations”;44
• a TREAS/IRS rule on “Rules Relating to the Additional Medicare Tax”;45
• a TREAS/IRS rule on “Health Insurance Provider Fees”;46 and
• an SSA rule on “Conforming Changes to Regulations Regarding Income-Related
Monthly Adjustment Amounts to Medicare Part B Premiums.”47
An additional two upcoming final rules were expected to be issued in December 2013, but had
not yet been issued as of January 23, 2014:
• a TREAS/IRS rule on “Community Health Needs Assessments for Charitable
Hospitals”; and
• an HHS/CMS and DOL/EBSA joint rule on “Ninety-Day Waiting Period
Limitation and Technical Amendments to Certain Health Coverage Requirements
Under the Affordable Care Act.”48
The remaining final rules listed in the Unified Agenda are expected to be issued sometime during
2014.
ACA Long-Term Actions
As noted earlier in this report, the Unified Agenda also identifies “long-term actions” (i.e.,
regulatory actions that are under development which the agencies do not expect to take action on
in the next 12 months). The Fall 2013 edition of the Unified Agenda listed 12 long-term actions
related to ACA. In comparison to the proposed and final rules previously discussed, it is much
less clear when the ACA-related long-term actions are expected to occur. In 4 of the 12 long-term
actions listed, the agencies said that the dates for the actions were “to be determined”:
• an HHS/HRSA proposed rule on “340B Civil Monetary Penalties for
Manufacturers”;
• an HHS/HRSA proposed rule on “340B Drug Pricing Program; Administrative
Dispute Resolution Process”;
• an HHS/HRSA proposed rule on “340B Ceiling Price Regulations”; and
• a DOL/EBSA “undetermined” action on “Automatic Enrollment in Health Plans
of Employees of Large Employers Under FLSA Section 18A.”
44 U.S. Department of the Treasury, Internal Revenue Service, “Computation of, and Rules Relating to, Medical Loss
Ratio,” 79 Federal Register 755, January 7, 2014.
45 U.S. Department of the Treasury, Internal Revenue Service, “Rules Relating to Additional Medicare Tax,” 78
Federal Register 71468, November 29, 2013.
46 U.S. Department of the Treasury, Internal Revenue Service, “Health Insurance Providers Fee,” 78 Federal Register
71476, November 29, 2013.
47 Social Security Administration, “Medicare Determinations and Income-Related Monthly Adjustment Amounts to
Medicare Part B Premiums; Conforming Changes to Regulations,” 78 Federal Register 57257, September 18, 2013.
48 This rule will also be issued jointly with TREAS/IRS, although TREAS/IRS included it in the long-term actions
portion of the Unified Agenda and estimated it would be published in December 2014.
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Upcoming Rules Pursuant to the Patient Protection and Affordable Care Act
Of the eight remaining long-term actions for which agencies provided an estimated date of
publication, two are expected to be published in November 2014:
• an HHS/CMS final rule on “Medicare Shared Savings Program; Final Waivers”;
and
• a Department of Justice/Civil Rights Division (CRT) advance notice of proposed
rulemaking on “Nondiscrimination on the Basis of Disability by State and Local
Governments and Public Accommodations: Accessibility of Medical Equipment
and Furniture.”
Four rules are estimated to be published in December 2014, all of which are TREAS/IRS final
rules:
• “Group Health Plans and Health Insurance Issuers Providing Dependent
Coverage of Children to Age 26 Under the Patient Protection and Affordable
Care Act”;
• “Group Health Plans and Health Insurance Coverage Rules Relating to Status as
a Grandfathered Health Plan Under the Patient Protection and Affordable Care
Act”;
• “Requirements for Group Health Plans and Health Insurance Issuers Under the
PPACA Relating to Preexisting Condition Exclusions, Lifetime and Annual
Limits, Rescissions, and Patient Protections”; and
• “Requirements for Group Health Plans and Health Insurance Issuers Relating to
Internal Claims and Appeals and External Review Processes Under the Patient
Protection and Affordable Care Act.”
One additional item indicating that its estimated publication would be December 2014 was a
TREAS/IRS rule referenced earlier in this report that will be issued jointly with HHS/CMS and
DOL/EBSA entitled “Ninety-Day Waiting Period Limitation and Technical Amendments to
Certain Health Coverage Requirements Under the Affordable Care Act.” HHS/CMS indicated in
the Unified Agenda that they expected the rule to be issued in December 2013, while DOL/EBSA
estimated that the rule would be issued in February 2014.
Finally, one regulatory action is expected in 2015: an HHS/CMS final rule on “Reporting and
Returning of Overpayments,” which the agency estimates it will publish in February 2015.
Notable Long-Term Actions
None of the rules in the long-term actions section were considered “major.” In 8 of the 12 actions
listed, agencies indicated that they did not expect the rules to be “major,” and in the remaining 4,
agencies had not yet determined whether any of the rules would be “major.”
The agencies considered 5 of the 12 actions to be “other significant,” meaning that the agencies
considered them significant enough to be reviewed by OIRA under Executive Order 12866, but
not “economically significant”:
• an HHS/HRSA rule on “340B Drug Pricing Program; Administrative Dispute
Resolution Process”;
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• an HHS/CMS rule on “Reporting and Returning of Overpayments”;
• an HHS/CMS rule on “Medicare Shared Savings Program; Final Waivers”;
• a DOJ/CRT rule on “Nondiscrimination on the Basis of Disability by State and
Local Governments and Public Accommodations: Accessibility of Medical
Equipment and Furniture”; and
• a DOL/EBSA rule on “Automatic Enrollment in Health Plans of Employees of
Large Employers Under FLSA Section 18A.”
Congressional Oversight Options
As noted earlier in this report, when federal agencies issue substantive regulations they are
carrying out legislative authority delegated to them by Congress. Therefore, Congress often
oversees the rules that agencies issue to ensure that they are consistent with congressional intent
and various rulemaking requirements. In order for Congress to oversee the rules issued pursuant
to the ACA, Congress must first know that they are being issued—ideally as early as possible.
The Unified Agenda is perhaps the best vehicle to provide that early information, as it describes
not only what rules are expected to be issued and provides information regarding their
significance and timing.
Congress has a range of tools available to oversee the rules that federal agencies are expected to
issue to implement the ACA, including oversight hearings and confirmation hearings for the
heads of regulatory agencies. Individual Members of Congress may also participate in the
rulemaking process by, among other things, meeting with agency officials and filing public
comments.49 Congress, committees, and individual Members can also request that the
Government Accountability Office (GAO) evaluate the agencies’ rulemaking activities.
Another option is the Congressional Review Act (CRA, 5 U.S.C. §§801-808), which was enacted
in 1996 to establish procedures detailing congressional authority over rulemaking “without at the
same time requiring Congress to become a super regulatory agency.”50 The act generally requires
federal agencies to submit all of their covered final rules to both houses of Congress and GAO
before they can take effect.51 It also established expedited legislative procedures (primarily in the
Senate) by which Congress may disapprove agencies’ final rules by enacting a joint resolution of
disapproval.52 The definition of a covered rule in the CRA is quite broad, arguably including any
type of document (e.g., legislative rules, policy statements, guidance, manuals, and memoranda)
49 For example, in Sierra Club v. Costle (657 F.2d 298, D.C. Cir. 1981), the D.C. Circuit concluded (at 409) that it was
“entirely proper for congressional representatives vigorously to represent the interests of their constituents before
administrative agencies engaged in informal, general policy rulemaking, so long as the individual Members of
Congress do not frustrate the intent of Congress as a whole as expressed in statute, nor undermine applicable rules of
procedure.”
50 Joint statement of House and Senate Sponsors, Congressional Record, daily edition, vol. 142 (April 19, 1996), p.
E571, and Congressional Record, daily edition, vol. 142 (April 18, 1996), p. S3683.
51 If a rule is considered “major” (e.g., has a $100 million annual effect on the economy), then the CRA generally
prohibits it from taking effect until 60 days after the date that it is submitted to Congress.
52 For a detailed discussion of CRA procedures, see CRS Report RL31160, Disapproval of Regulations by Congress:
Procedure Under the Congressional Review Act, by Richard S. Beth.
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Upcoming Rules Pursuant to the Patient Protection and Affordable Care Act
that the agency wishes to make binding on the affected public.53 After these rules are submitted,
Congress can use the expedited procedures specified in the CRA to disapprove any of the rules.
CRA resolutions of disapproval must be presented to the President for signature or veto.
For a variety of reasons, however, the CRA has been used to disapprove of only one rule in the 18
years since it was enacted.54 Perhaps most notably, it is likely that a President would veto a
resolution of disapproval to protect rules developed under his own Administration, and it may be
difficult for Congress to muster the two-thirds vote in both houses needed to overturn the veto.
Congress can also use regular (i.e., non-CRA) legislative procedures to disapprove agencies’
rules, but such legislation may prove even more difficult to enact than a CRA resolution of
disapproval (primarily because of the lack of expedited procedures in the Senate), and if enacted
could be subject to presidential veto.
Finally, outside the CRA, Congress has regularly included provisions in the text of agencies’
appropriations bills in order to influence the regulatory process.55 Such provisions include
prohibitions on the finalization of particular proposed rules, restrictions on certain types of
regulatory activity, and restrictions on implementation or enforcement of certain provisions.
Appropriations provisions can also be used to prompt agencies to issue certain regulations or to
require that certain procedures be followed before or after their issuance. The inclusion of
regulatory provisions in appropriations legislation as a matter of legislative strategy appears to
arise from two factors: (1) Congress’s ability via its “power of the purse” to control agency
action, and (2) the fact that appropriations bills are usually considered “must pass” legislation.
Congress’s use of regulatory appropriations restrictions has fluctuated somewhat over time.56
This report’s Appendix contains a table listing the upcoming proposed and final rules published
in the Fall 2013 Unified Agenda. For each upcoming proposed and final rule listed, the table
identifies the department and agency expected to issue the rule, the title of the rule and its RIN, an
abstract describing the nature of the rulemaking action, and the date that the proposed or final rule
is expected to be issued.57 The abstracts presented in the table were taken verbatim from the
Unified Agenda entries. Within the proposed and final rule sections of the table, the entries are
organized by agency. The table includes only those Unified Agenda entries in which the
Affordable Care Act was mentioned.
53 The CRA provides for three exceptions to the definition of the term “rule.” Under 5 U.S.C. §804(3), the term “rule”
does not include “(A) any rule of particular applicability, including a rule that approves or prescribes for the future
rates, wages, prices, services, or allowances therefor, corporate or financial structures, reorganizations, mergers, or
acquisitions thereof, or accounting practices or disclosures bearing on any of the foregoing; (B) any rule relating to
agency management or personnel; or (C) any rule of agency organization, procedure, or practice that does not
substantially affect the rights or obligations of non-agency parties.”
54 The rule overturned in March 2001 was the Occupational Safety and Health Administration’s ergonomics standard.
This reversal was the result of a unique set of circumstances in which the incoming President (George W. Bush) did not
veto the resolution disapproving the outgoing President’s (William J. Clinton’s) rule.
55 For more information on the use of appropriations restrictions, see CRS Report R41634, Limitations in
Appropriations Measures: An Overview of Procedural Issues, by Jessica Tollestrup.
56 Ibid., p. 35. This report indicated that some appropriations restrictions were repeated every year for 10 years, some
were repeated several years in a row but then stopped, and some appeared in only one appropriations bill. Some
restrictions appeared to be intended to stop particular rules issued at the end of presidential administrations.
57 In addition to the RINs, CMS included an agency-specific number as part of the title of the rule (e.g., CMS-2327-F).
Those numbers are included as part of the title in the table in the Appendix.
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Appendix. Upcoming Proposed and Final Rules Pursuant to the Patient
Protection and Affordable Care Act
Department/
Expected
Agency
Title of Rule (RIN)
Abstract, as Provided in the Fall 2013 Unified Agenda
Publication Date
Proposed Rules
HHS/HRSA
Teaching Health Center
This proposed rule is required under the Affordable Care Act (ACA) and would create regulations
06/2014
Graduate Medical
governing the eligibility, payment amount, reconciliation, and annual reporting for the Teaching
Education Program
Health Centers Graduate Medical Education Program.
(0906-AA98)
HHS/OIG
Medicare and State
This rule makes changes to the Civil Monetary Penalties Law (CMPL) regulations at 42 CFR 1003 to
04/2014
Health Care Programs:
implement authorities under the [ACA] and other statutes. ACA provides for CMPs, assessments,
Fraud and Abuse;
and exclusion for: Failure to grant timely access to OIG; Ordering or prescribing while excluded;
Revisions to the Office
Making false statements, omissions, or misrepresentations in an enrollment application; Failure to
of the Inspector
return an overpayment; and Making or using a false record or statement that is material to a false or
General’s Civil Monetary
fraudulent claim. These statutory changes are reflected in the proposed regulations. We also
Penalty Rules (0936-
propose a reorganization of 42 CFR 1003 to make the regulations more accessible to the public and
AA04)
to add clarity to the regulatory scheme. We propose an alternate methodology for calculating
penalties and assessments for employing excluded individuals in positions in which the individuals do
not directly bill the Federal health care programs for furnishing items or services. We also clarify the
liability guidelines under OIG authorities, including the CMPL, the Emergency Medical Treatment
and Labor Act; section 1140 of the Social Security Act for conduct involving electronic mail,
Internet, and telemarketing solicitations; and section 1927 of the Social Security Act for late or
incomplete reporting of drug-pricing information.
HHS/OIG
Fraud and Abuse;
The [ACA] significantly expanded OIG’s authority to protect Federal health care programs from
04/2014
Revisions to the Office
fraud and abuse. OIG proposes to update its regulations to codify the changes made by ACA in the
of Inspector General’s
regulations. At the same time, OIG proposes updates pursuant to the Medicare Prescription Drug
Exclusion Authorities
Improvement and Modernization Act of 2003 (MMA) and other statutory authorities, as well as
(0936-AA05)
technical changes to clarify and update the regulations.
CRS-16
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Department/
Expected
Agency
Title of Rule (RIN)
Abstract, as Provided in the Fall 2013 Unified Agenda
Publication Date
HHS/OIG
Medicare and State
This proposed rule amends the safe harbors to the anti-kickback statute and the civil monetary
07/2014
Health Care Programs:
penalty rules under the authority of the Office of Inspector General (OIG). The proposed rule
Fraud and Abuse;
would add new safe harbors, some of which codify statutory changes set forth in the Medicare
Revisions to Safe
Prescription Drug Improvement and Modernization Act of 2003 (MMA) and [ACA] and all of which
Harbors Under the Anti-
would protect certain payment practices and business arrangements from criminal prosecution and
Kickback Statute, and
civil sanctions under the anti-kickback provisions of the statute. We also propose to codify ACA’s
Civil Monetary Penalty
revised definition of “remuneration” and add a gainsharing civil monetary penalty (CMP or penalty)
Rules Regarding
provision in 42 CFR part 1003.
Beneficiary Inducements
and Gainsharing (0936-
AA06)
HHS/CMS Administrative This proposed rule would implement provisions of the [ACA] under Administrative Simplification to
NPRM was published
Simplification:
certify that data and information systems are in compliance with any applicable standards and
on 01/02/2014 (79
Compliance: Health Plan
associated operating rules for electronic funds transfers, eligibility for a health plan, health claim
F.R. 297).
Certification (CMS-0037-
status, and health care payment and remittance advice.
P) (0938-AQ85)
Note: Legal deadline
was 12/31/2013.
HHS/CMS
Reform of Requirements
This proposed rule would reform the Medicare conditions of participation for long-term care
03/2014
for Long-Term Care
facilities to reflect significant changes in the industry and remove obsolete or unnecessary
Facilities and Quality
provisions. In addition, under the [ACA], this rule would propose to expand the level and scope of
Assurance and
required [Quality Assurance & Performance Improvement] activities to ensure that facilities
Performance
continuously identify and correct quality deficiencies as wel as promote and sustain performance
Improvement (QAPI)
improvement.
Program (CMS-3260-P)
(0938-AR61)
HHS/CMS Prospective
Payment
This final rule establishes methodology and payment rates for a prospective payment system (PPS)
NPRM was published
System for Federally
for federal y qualified health center (FQHC) services under Medicare Part B beginning on October 1, on 09/23/2013 (78
Qualified Health
2014, in compliance with the statutory requirement of the [ACA]. This rule also establishes a policy
F.R. 58386).
Centers; Changes to
which would al ow rural health clinics (RHCs) to contract with nonphysician practitioners when
Contracting Policies for
statutory requirements for employment of nurse practitioners and physician assistants are met, and
Note: Legal deadline
Rural Health Clinics and
makes other technical and conforming changes to the RHC and FQHC regulations. Finally, this rule
is 10/01/2014. Final
CLIA Enforcement
makes changes to the Clinical Laboratory Improvement Amendments (CLIA) regulations regarding
rule expected
Actions for Proficiency
enforcement actions for proficiency testing referral.
08/2014.
Testing Referral (CMS-
1443-F) (0938-AR62)
CRS-17
.
.
Department/
Expected
Agency
Title of Rule (RIN)
Abstract, as Provided in the Fall 2013 Unified Agenda
Publication Date
HHS/CMS
CY 2015 Notice of
This proposed rule would establish the CY 2015 payment parameters for the cost-sharing
NPRM was published
Benefit and Payment
reductions, advance premium tax credit, reinsurance, and risk adjustment programs as required by
on 12/02/2013 (78
Parameters (CMS-9954-
the [ACA].
F.R. 72322).
P) (0938-AR89)
Note: Proposed and
subsequent final rule
must precede plan
approval and open
enrol ment (must be
complete by
01/01/2014).
HHS/CMS
Establishment of the
This final rule establishes the Basic Health Program as required by the [ACA]. The Basic Health
NPRM was published
Basic Health Program
Program provides States the flexibility to establish an alternative coverage program for low-income
on 09/25/2013 (78
(CMS-2380-F) (0938-
individuals who would otherwise be eligible to purchase coverage through the exchange. This final
F.R. 58786).
AR93)
rule addresses eligibility and enrollment, benefits, delivery of health care services, transfer of funds
to participating states, and secretarial oversight relating to the Basic Health Program.
Note: Legal deadline
was 01/01/2014. Final
rule expected
03/2014.
HHS/CMS
Establishment of Quality
This proposed rule would establish requirements for exchanges and for qualified health plans to
03/2014
Standards for Exchanges
implement specific quality related provisions of the [ACA]. In addition, this rule would establish an
and Qualified Health
appeals process for enrol ee satisfaction survey vendors.
Plans (QHPs) (CMS-
3288-P) (0938-AS00)
HHS/CMS Eligibility,
Enrollment,
This proposed rule would update policy based on experience with initial open enrollment.
02/2014
and Appeals Updates
(CMS-9949-P) (0938-
AS02)
HHS/OCR Nondiscrimination This proposed rule would implement prohibitions against discrimination on the basis of race, color,
08/2014
Under the Patient
national origin, sex, age, and disability, as provided in section 1557 of the [ACA]. Section 1557
Protection and
provides protection from discrimination in health programs and activities of covered entities. This
Affordable Care Act
section also identifies additional forms of Federal financial assistance to which the section will apply.
(0945-AA02)
DOL/EBSA Amendments
to This document contains proposed rules that would amend the regulations regarding excepted
NPRM was published
Excepted Benefits (1210-
benefits under the Employee Retirement Income Security Act of 1974, the Internal Revenue Code,
on 12/24/2013 (78
AB60)
and the Public Health Service Act, as amended by the Health Insurance Portability and
F.R. 77632).
Accountability Act (HIPAA) and the [ACA].
CRS-18
.
.
Department/
Expected
Agency
Title of Rule (RIN)
Abstract, as Provided in the Fall 2013 Unified Agenda
Publication Date
TREAS/IRS
Fees on Health Insurance The proposed regulations provide guidance under sections 4375 to 4377 of the Internal Revenue
12/2013
and Self-Insured Plans
Code, as added by section 6301 of the [ACA], on fees imposed on health insurance and self-insured
(1545-BK59)
health plans.
Note: TREAS/IRS
published this rule as
an NPRM on
04/17/2012 (77 F.R.
22691) and a final
rule on 12/06/2012
(77 F.R. 72721). It is
unclear why the rule
is listed in the
proposed rule
section of the Unified
Agenda.
TREAS/IRS
Reporting and Notice
Proposed regulations under section 6056 of the Internal Revenue Code, as enacted by the [ACA],
NPRM was published
Requirements Under
to provide guidance on rules that require applicable large employers to file certain information with
on 09/09/2013 (78
Section 6056 (1545-
the Internal Revenue Service on coverage under an eligible employer-sponsored health plan and
F.R. 54996).
BL26)
furnish to individuals statements that set forth the information required to be reported to the
Internal Revenue Service.
TREAS/IRS
Tax Credit for Employee
Proposed regulations under section 45R of the Internal Revenue Code, as enacted by the [ACA],
NPRM was published
Health Insurance
that set forth the requirements for certain small employers to claim a tax credit when providing
on 08/23/2013 (78
Expenses of Small
health insurance coverage to their employees through an Exchange.
F.R. 52719).
Employer (1545-BL55)
Note: Final rule listed
as expected 12/2013;
had not been
published as of
01/23/2014.
TREAS/IRS
Requirement of a Section The regulations provide guidance to charitable hospital organizations that are liable for the excise
NPRM was published
4959 Excise Tax Return
tax, enacted as part of the [ACA], for failing to satisfy the community health needs assessment
08/15/2013 (78 F.R.
and Time for Filing the
(CHNA) requirements. The regulations specify the return to accompany payment of the excise tax
49700).
Return (1545-BL57)
and the time for filing that return.
OPM Federal
Employees’
The U.S. Office of Personnel Management (OPM) proposes to amend the Federal Employees’ Health 12/2013
Health Benefits Program; Benefits (FEHB) regulations at 5 CFR part 890 to include changes to resolution of disputed health
Disputed Claims and
claims and to provide for external review under the provisions of the [ACA].
Note: NPRM had not
External Review
been published as of
Requirements (3206-
01/23/2014.
AM42)
CRS-19
.
.
Department/
Expected
Agency
Title of Rule (RIN)
Abstract, as Provided in the Fall 2013 Unified Agenda
Publication Date
OPM Federal
Employees’
The U.S. Office of Personnel Management (OPM) proposes to amend the Federal Employees’ Health 02/2014
Health Benefits Program: Benefits (FEHB) regulations at 5 CFR part 890 to include changes under the provisions of the
Miscellaneous Changes
[ACA].
Proposed by the
Affordable Care Act
(3206-AM46)
Final Rules
HHS/HRSA
Designation of Medically
The [ACA] required the Secretary to establish a rulemaking committee to draft an interim final rule
09/2014
Underserved Populations for designation of Medically Underserved Populations (MUPs) and Primary Care Health Professions
and Health Professional
Shortage Areas (HPSAs). The rulemaking committee was unable to reach the consensus required to
Note: Original NPRM
Shortage Areas (0906-
produce an interim final rule for the Secretary’s review and approval. However, the [ACA] still
was published on
AA44)
requires the Secretary to issue an interim final rule at some point in the future.
09/01/1998 (63 F.R.
46538). Second
NPRM was published
on 07/23/2008 (73
F.R. 42743).
HHS/FDA
Food Labeling: Calorie
FDA published a proposed rule to establish requirements for nutrition labeling of certain food items
02/2014
Labeling of Articles of
sold in certain vending machines. FDA also proposed the terms and conditions for vending machine
Food Sold in Vending
operators registering to voluntarily be subject to the requirements. FDA is issuing a final rule, and
Note: NPRM was
Machines (0910-AG56)
taking this action to carry out section 4205 of the [ACA].
published on
04/06/2011 (76 F.R.
19238).
HHS/FDA
Food Labeling: Nutrition
FDA published a proposed rule in the Federal Register to establish requirements for nutrition
02/2014
Labeling of Standard
labeling of standard menu items in chain restaurants and similar retail food establishments. FDA also
Menu Items in
proposed the terms and conditions for restaurants and similar retail food establishments registering
Note: NPRM was
Restaurants and Similar
to voluntarily be subject to the Federal requirements. FDA is issuing a final rule, and taking this
published on
Retail Food
action to carry out section 4205 of the [ACA].
04/06/2011 (76 F.R.
Establishments (0910-
19192).
AG57)
CRS-20
.
.
Department/
Expected
Agency
Title of Rule (RIN)
Abstract, as Provided in the Fall 2013 Unified Agenda
Publication Date
HHS/CMS
Home and Community-
This final rule defines and describes state plan home and community-based services (HCBS) under
Final rule was
Based State Plan Services the [ACA]. It describes Medicaid coverage of an optional state plan benefit to furnish HCBS and
published on
Program, Waivers, and
draw federal matching funds. Also, this rule makes several changes to the regulations implementing
01/16/2014 (79 F.R.
Provider Payment
Medicaid HCBS waivers.
2947).
Reassignments (CMS-
2249-F) (0938-AO53)
Note: NPRM was
published on
04/04/2008 (73 F.R.
18676); second
NPRM was published
on 05/03/2012 (77
F.R. 26362).
HHS/CMS Face-to-Face
This final rule revises the Medicaid home health service definition as required by section 6407 of the
09/2014
Requirements for Home
[ACA] to add a requirement that physicians document the existence of a face-to-face encounter
Health Services; Policy
(including through the use of telehealth) with the Medicaid eligible individual within reasonable
Note: NPRM was
Changes and
timeframes. In addition, this rule amends home health services regulations to clarify the definitions
published on
Clarifications Related to
of included medical supplies, equipment and appliances, and clarify that States may not limit home
07/12/2011 (76 F.R.
Home Health (CMS-
health services to services delivered in the home, or to services furnished to individuals who are
41032).
2348-F) (0938-AQ36)
homebound.
HHS/CMS Covered
Outpatient
This final rule revises requirements pertaining to Medicaid reimbursement for covered outpatient
05/2014
Drugs (CMS-2345-F)
drugs to implement provisions of the [ACA]. This rule also revises other requirements related to
(0938-AQ41)
covered outpatient drugs, including key aspects of Medicaid coverage, payment, and the drug rebate
Note: NPRM was
program.
published on
02/02/2012. Legal
deadline was
01/01/2010.
HHS/CMS
Adoption of Operating
Under the [ACA], this interim final rule adopts operating rules for HIPAA transactions for health
06/2014
Rules for HIPAA
care claims or equivalent encounter information, enrollment and disenrollment of a health plan,
Transactions (CMS-
health plan premium payments, and referral certification and authorization.
Note: Statute
0036-IFC) (0938-AS01)
requires operating
rules be adopted by
07/01/2014 and
effective 01/01/2016.
CRS-21
.
.
Department/
Expected
Agency
Title of Rule (RIN)
Abstract, as Provided in the Fall 2013 Unified Agenda
Publication Date
HHS/OS
Health and Human
HHS is amending its Federal Acquisition Regulation (FAR) supplement – the HHS Acquisition
04/2014
Services Acquisition
Regulation (HHSAR)—to add four new clauses, 352.203-70 Anti-Lobbying, 352.204-16 Prevention
Regulation (HHS’
and Public Health Fund—Reporting Requirements, 352.231-70 Salary Rate Limitation, and 352.237-
Supplement to the
73 Nondiscrimination in Service Delivery, and their respective prescriptions at 303.808-70,
Federal Acquisition
304.1602, 331.101-70, and 337.103-70(d) as wel as amending related regulations at 303.808-70,
Regulation) (0991-AB88)
304.16, 304.1600, 304.1601, 304.1602, 305.8, 305.801, 305.802, 305.803, 305.804, 305.805, 331.101-
70, 335.017-2, 337.103-70(d). This interim final rule amends the Department’s FAR Supplement—
the HHS Acquisition Regulation (HHSAR)—to provide implementation guidance for provisions in
the HHS FY 2012 Appropriations Acts and to establish HHS’ nondiscrimination policy.
DOL/OSHA
Procedures for the
OSHA is proposing to promulgate procedures for the handling and investigation of retaliation
07/2014
Handling of Retaliation
complaints pursuant to Section 1558 of the [ACA]. This section established a new whistleblower
Complaints Under
protection statute to be administered by OSHA that provides protection from retaliation to
Note: Interim final
Section 1558 of the
employees in the health care industry who engage in protected activities under the ACA. Pursuant
rule was published on
Affordable Care Act of
to the statute, the procedures wil fol ow those enacted under the Consumer Product Safety
02/27/2013 (78 F.R.
2010 (1218-AC79)
Improvement Act, 15 U.S.C. 2087(b), including remedies and legal burdens of proof provisions.
13222).
Promulgation of a regulation is necessary to govern whistleblower investigations conducted under
the new statute. The ACA interim final rule was published February 27, 2013.
TREAS/IRS Branded
Prescription
Implementation of section 9008 applies to imposition of annual fee on branded prescription
06/2014
Drug Fee (1545-BJ39)
pharmaceutical manufacturers and importers.
Note: NPRM was
published on
08/18/2011 (76 F.R.
51310).
TREAS/IRS Requirements
for
Group
These proposed regulations provide guidance requiring coverage of certain preventive health
07/2014
Health Plans and Health
services without cost-sharing under section 2713 of the Public Health Service Act, incorporated into
Insurance Issuers
section 9815 of the Internal Revenue Code by section 1563(f) of the [ACA].
Note: NPRM was
Relating to Coverage of
published on
Preventive Services
07/19/2010; second
Under the Patient
NPRM was published
Protection and
on 03/03/2011.
Affordable Care Act
(1545-BJ58)
CRS-22
.
.
Department/
Expected
Agency
Title of Rule (RIN)
Abstract, as Provided in the Fall 2013 Unified Agenda
Publication Date
TREAS/IRS
Rules Relating to the
Proposed amendments of sections 31.3101, 31.3102, 31.3202, 31.1401, 31.6205, 31.6011, 31.6402,
Final rule was
Additional Medicare Tax
and 31.6413 of the Employment Tax Regulations provide guidance for employers and employees
published on
(1545-BK54)
relating to the implementation of the Additional Medicare Tax, as enacted by the [ACA], and
11/29/2013 (78 F.R.
correction procedures for errors related to the Additional Medicare Tax.
71468).
Note: NPRM was
published on
12/05/2012 (77 F.R.
72268).
TREAS/IRS
Medical Loss Ratio for
The final regulations will provide guidance under section 833(c)(5) of the Internal Revenue Code, as
Final rule was
Section 833
added by section 9016 of the [ACA], on the 85 percent medical loss ratio requirement under
published on
Organizations (1545-
section 833.
01/07/2014 (79 F.R.
BL05)
755).
Note: NPRM was
published on
05/13/2013 (78 F.R.
27873).
TREAS/IRS Health
Insurance The proposed regulations provide guidance on the annual fee imposed on covered entities engaged
Final rule was
Provider Fees (1545-
in the business of providing health insurance for United States health risks. This fee was enacted by
published on
BL20)
section 9010 of the Patient Protection and Affordable Care Act (P.L. 111-148), as amended by
11/29/2013 (78 F.R.
section 10905 and further amended by section 1406 of Health Care and Education Reconciliation
71476).
Act of 2010 (P.L. 111-152).
Note: NPRM was
published on
03/04/2013 (78 F.R.
14034).
TREAS/IRS Community
Health
The Notice of Proposed Rulemaking contains proposed regulations that provide guidance to
12/2013
Needs Assessments for
charitable hospital organizations on the community health needs assessment requirements, and
Charitable Hospitals
related excise tax and reporting obligations, enacted in the [ACA]. The proposed regulations also
Note: NPRM was
(1545-BL30)
clarify the consequences for failing to meet these requirements, as well as additional requirements
published on
related to financial assistance, charges, and billing and collections. The proposed regulations will
04/02/2013 (78 F.R.
affect charitable hospital organizations.
20523). Final rule had
not been published as
of 01/23/2014.
CRS-23
.
.
Department/
Expected
Agency
Title of Rule (RIN)
Abstract, as Provided in the Fall 2013 Unified Agenda
Publication Date
TREAS/IRS
Shared Responsibility for
Final regulations under section 4980H of the Internal Revenue Code, as enacted by the [ACA], to
12/2013
Employers Regarding
provide guidance relating to the offering of health coverage by applicable large employers to their
Health Coverage (1545-
ful -time employees.
Note: NPRM was
BL33)
published on
01/02/2013 (78 F.R.
218). Final rule had
not been published as
of 01/23/2014.
ATBCB Accessibility
Standards
This regulation will establish minimum technical criteria to ensure that medical equipment used for
09/2014
for Medical Diagnostic
diagnostic purposes by health professionals in or in conjunction with physician’s offices, clinics,
Equipment (3014-AA40)
emergency rooms, hospitals, and other medical settings is accessible to and usable by individuals
Note: NPRM was
with disabilities.
published on
02/09/2012 (77 F.R.
6916). Legal deadline
was 03/22/2012.
OPM Federal
Employees’
The United States Office of Personnel Management (OPM) plans to issue a final rule to amend the
03/2014
Health Benefits Program: Federal Employees’ Health Benefits (FEHB) Program regulations regarding coverage for Members of
Members of Congress
Congress and congressional staff, in light of the new requirement in section 1312 of the [ACA].
Note: NPRM was
and Congressional Staff
published on
(3206-AM85)
08/08/2013 (78 F.R.
48337).
SSA
Conforming Changes to
We are modifying our regulations to the Medicare Part B income-related monthly adjustment
Interim final rule was
Regulations Regarding
amount (IRMAA) in order to conform to changes made to the Social Security Act (Act) by the
published 09/18/2013
Income-Related Monthly
[ACA]. These rules remove the requirement that beneficiaries consent to the release of IRS
(78 F.R. 57257).
Adjustment Amounts to
information outside of SSA for appeals past the reconsideration level and freeze the income
Medicare Part B
threshold and ranges from 2011 through 2019. We are also removing provisions that phased in the
Premiums (3734I) (0960-
income-related monthly adjustment amount between 2007 and 2009. The regulation also updates an
AH47)
outdated provision to reflect the transfer of authority for hearing appeals under title XVIII of the
Act from SSA to the Department of Health and Human Services, as prescribed by the Medicare
Prescription Drug, and Modernization Act of 2003.
CRS-24
.
.
Department/
Expected
Agency
Title of Rule (RIN)
Abstract, as Provided in the Fall 2013 Unified Agenda
Publication Date
HHS/CMS,
Ninety-Day Waiting
This final rule implements the 90-day waiting period limitation under section 2708 of the Public
12/2013
DOL/EBSA,
Period Limitation and
Health Service Act, as added by the [ACA], as amended, and incorporated into the Employee
TREAS/IRS
Technical Amendments
Retirement Income Security Act of 1974 and the Internal Revenue Code. It also amends regulations
Note: CMS and EBSA
to Certain Health
to conform to [ACA] provisions already in effect as well as those that will become effective
listed this joint rule
Coverage Requirements
beginning 2014.
separately in the
Under the Affordable
Unified Agenda; CMS
Care Act (CMS-9952-F)
estimated the final
(0938-AR77, 1210-AB56,
rule to be completed
1545-BL50)
in 12/2013 and EBSA
estimated it to be
completed in
02/2014. IRS listed
the rule in the long-
term actions section
of the Agenda and
estimated it would be
published in 12/2014.
NPRM was published
03/21/2013 (78 F.R.
17313). Legal
deadline was
01/01/2014. Final rule
had not been
published as of
01/23/2014.
Source: Information in the first three columns is verbatim as reported in the Unified Agenda of Federal Regulatory and Deregulatory Actions, November 26, 2013, at
http://www.reginfo.gov/public/do/eAgendaMain. Expected publications dates and information about legal deadlines listed in the fourth column are from the Unified Agenda.
Publication information on the rules that have been published is from the Federal Register itself, accessed through the Government Printing Office’s Federal Digital System.
Note: The table includes only those Unified Agenda entries in which the Affordable Care Act was mentioned.
CRS-25
.
.
Upcoming Rules Pursuant to the Patient Protection and Affordable Care Act
Author Contact Information
Maeve P. Carey
Michelle D. Christensen
Analyst in Government Organization and
Analyst in Government Organization and
Management
Management
mcarey@crs.loc.gov, 7-7775
mchristensen@crs.loc.gov, 7-0764
Congressional Research Service
26