Upcoming Rules Pursuant to the Patient Protection and Affordable Care Act: The 2012 Unified Agenda

Upcoming Rules Pursuant to the Patient
Protection and Affordable Care Act: The 2012
Unified Agenda
Maeve P. Carey
Analyst in Government Organization and Management
Michelle D. Christensen
Analyst in Government Organization and Management
February 1, 2013
Congressional Research Service
7-5700
www.crs.gov
R42946
CRS Report for Congress
Pr
epared for Members and Committees of Congress

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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. ACA is a comprehensive overhaul of the health care
system that includes such provisions as the expansion of eligibility for Medicaid, amendments to
Medicare that are intended to reduce its growth, an individual mandate for the purchase of health
insurance, and the establishment of insurance exchanges through which individuals and families
can receive federal subsidies to help them purchase insurance. As is the case with many laws that
Congress passes, ACA contains many instances of delegation of rulemaking authority to federal
agencies.
One way in which Congress can identify upcoming rules and regulations that will be issued
pursuant to ACA is by reviewing the Unified Agenda of Federal Regulatory and Deregulatory
Actions (hereafter, 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) 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• “completed” actions (i.e., final rules or rules that have been withdrawn since the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 have uniform data elements, including 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 December 21, 2012, is
the fourth edition of the Unified Agenda since enactment of ACA. In this edition, agencies
reported 23 proposed rules and 18 final rules that they expect to issue pursuant to ACA within the
next 12 months. Agencies also reported a total of 22 long-term regulatory actions and 20
completed actions.
The Appendix of this report lists the upcoming proposed and final rules published in the 2012
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
This Report ................................................................................................................................ 4
Upcoming ACA Proposed Rules ...................................................................................................... 5
Notable Proposed Rules ............................................................................................................ 5
Economically Significant or Major Proposed Rules ........................................................... 6
“Other Significant” Proposed Rules .................................................................................... 6
Effects on Small Entities ..................................................................................................... 7
Timing of the Proposed Rules ................................................................................................... 8
Upcoming ACA Final Rules ............................................................................................................ 9
Notable Final Rules ................................................................................................................. 10
Economically Significant or Major Final Rules ................................................................ 10
“Other Significant” Final Rules ........................................................................................ 10
Effects on Small Entities ................................................................................................... 11
Timing of Final Rules .............................................................................................................. 12
ACA Long-Term Actions ............................................................................................................... 12
Notable Long-Term Actions .................................................................................................... 13
Congressional Oversight Options .................................................................................................. 13

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 and specific requirements are established. 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) is a particularly noteworthy example of
congressional delegation of rulemaking authority to federal agencies.1 ACA is a comprehensive
overhaul of the health care system that includes such provisions as the expansion of eligibility for
Medicaid, amendments to Medicare that are intended to reduce its growth, an individual mandate
for the purchase of health insurance, and the establishment of insurance exchanges through which
individuals and families can receive federal subsidies to help them purchase insurance. A previous
CRS report identified more than 40 provisions in ACA that explicitly require or permit the
issuance of rules to implement the law.2
The rules that agencies issue pursuant to ACA are expected to have a major impact on how the
law is implemented. For example, in an article entitled “The War Isn’t Over” that was posted on
the New England Journal of Medicine’s Health Care Reform Center shortly after 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. Many of these actions will provoke controversy...
Far from having ended, the war to make health care reform an enduring success has just
begun. Winning that war will require administrative determination and imagination and as
much political resolve as was needed to pass the legislation.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 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

1 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 ACA. Note that previous CRS reports on the Patient Protection and Affordable
Care Act used the acronym PPACA to refer to the law. CRS is now using the more common acronym ACA. For more
information on 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 is no longer at CRS; questions about its content can 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, available 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 contain a legislative enforcement mechanism. One potential option for enforcement is civil litigation, although
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in 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 ACA require agencies to establish programs or procedures but do
not specifically mention regulations.
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.
Having an early sense of what rules the agencies are going to issue and when can help Congress
to provide 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.6 However, the law does not 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).7 The Unified
Agenda 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)
Office of Information and Regulatory Affairs (OIRA).8 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

(...continued)
courts often defer to agencies’ judgment on the timing of their issuance of a rule.
5 David H. Rosenbloom, Building a Legislative-Centered Public Administration: Congress and the Administrative
State, 1946-1999 (Tuscaloosa, AL: The University of Alabama Press, 2000), pp. 133-134.
6 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 is no longer at CRS; questions about its content can be
directed to the authors of this report.
7 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. The fall 2011 edition was published in January 2012.
8 The current edition of the Unified Agenda is available at http://www.reginfo.gov/public/do/eAgendaMain.
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each year, describing regulatory actions that they are developing that may have a
significant economic impact on a substantial number of small entities.9
• 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.”10 The stated purposes of this and other planning
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 have uniform data elements, including the department and
agency issuing the rule, the title of the rule, the Regulation Identifier Number (RIN),11 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).12

9 This requirement applies to all agencies covered by the Administrative Procedure Act (5 U.S.C. §551(1)).
10 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
and Exchange Commission and Federal Reserve Board), this section of the order does include those agencies.
11 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.
12 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
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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 never get 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 it arguably provides federal agencies with the
most systematic, government-wide method to alert the public about their upcoming proposed
rules.13
This Report
The December 21, 2012, edition of the Unified Agenda is the fourth edition that RISC has
compiled and issued since the enactment of ACA.14 Federal agencies were required to submit data
to RISC for the Unified Agenda by September 7, 2012, but some items may have been
subsequently updated during the OIRA review process.15
This report examines the December 21, 2012, edition of the Unified Agenda and identifies
upcoming proposed and final rules and long-term regulatory actions that are expected to be issued
pursuant to 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 23 proposed rules and 18 final rules that they expect to issue
pursuant to ACA within the next 12 months. Agencies also reported a total of 22 long-term
regulatory actions and 20 completed 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 that the proposed or final rule is expected to be issued.16 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.

(...continued)
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.
13 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 is no longer at CRS; questions about its content can be directed to the authors of
this report.
14 ACA was enacted on March 23, 2010. The first edition of the Unified Agenda following enactment of ACA was
issued on December 20, 2010.
15 Memorandum from Cass R. Sunstein, Administrator of the Office of Information and Regulatory Affairs,
“Memorandum for Regulatory Policy Officers at Executive Departments and Agencies and Managing and Executive
Directors of Certain Agencies and Commissions,” June 13, 2012, at http://www.whitehouse.gov/sites/default/files/omb/
inforeg/for-agencies/fall-2012-regulatory-plan-and-unified-agenda-of-federal-regulatory-and-deregulatory-actions.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.
16 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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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, 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, 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, are not discussed in this report.
Upcoming ACA Proposed Rules
The December 21, 2012, edition of the Unified Agenda listed 23 ACA-related actions 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).17 Ten of the 23 upcoming proposed rules were expected to be issued by components of the
Department of Health and Human Services (HHS): Centers for Medicare and Medicaid Services
(CMS, nine actions) and the Office of Civil Rights (OCR, one action). Other proposed rules were
expected to be issued by the Treasury Department’s Internal Revenue Service (TREAS/IRS, six
actions); and the Office of Personnel Management (OPM, five actions). The remaining two
upcoming proposed rules were expected to be issued by the Department of Labor’s Employee
Benefits Security Administration (DOL/EBSA) jointly with HHS/CMS and TREAS/IRS.
Notable Proposed Rules
The Department of Health and Human Services considered three of the items in the “proposed
rule” section of the Unified Agenda important enough to be included in its regulatory plan. All
three rules were from HHS/CMS, and all three were considered “economically significant” or
“major.”18 The three rules HHS included in its regulatory plan are:
• a rule on “Standards Related to Essential Health Benefits”;19
• a rule on “Benefit and Payment Parameters,” which would provide additional
guidance for several programs including risk adjustment, reinsurance, and risk
corridors;20 and
• a rule that would establish a “Prospective Payment System for Federally
Qualified Health Centers.”

17 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 that they would each report it separately to the Unified Agenda, and such a rule would appear as two actions.
18 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. Economically significant and major proposed rules are discussed in the
following section.
19 Department of Health and Human Services, “Patient Protection and Affordable Care Act; Standards Related to
Essential Health Benefits, Actuarial Value, and Accreditation,” 77 Federal Register 70644, November 26, 2012.
20 Department of Health and Human Services, “Notice of Benefit and Payment Parameters,” 77 Federal Register
73118, December 7, 2012.
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Economically Significant or Major Proposed Rules
In addition to the three ACA-related proposed rules that were listed in the regulatory plan, the
Unified Agenda listed six other actions that the agencies considered “economically significant” or
“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). Four of the rules were
expected to be issued by HHS/CMS, one was to be issued by OPM, and one was expected to be
issued jointly by TREAS/IRS, DOL/EBSA, and HHS/CMS. The economically significant or
major proposed rules are
• an HHS/CMS rule on “Medicaid, Exchanges, and Children’s Health Insurance
Programs,” which was expected to be published sometime during December
2012, but had not been published as of January 14, 2013;
• an HHS/CMS rule on “Medicare Advantage (MA) and Prescription Drug Benefit
Programs,” which was expected to be published sometime during December
2012, but had not been published as of January 14, 2013;
• an HHS/CMS rule on “Health Insurance Market: Rate Review,” which the
agency published on November 26, 2012;21
• an HHS/CMS rule on “Administrative Simplification: Compliance with Health
Plan Certification,” which the agency expects to publish in March 2013;
• an OPM rule on “Multi-State Exchanges,” which the agency published on
December 5, 2012;22 and
• a rule on “Preventive Services,” which was published as an ANPRM by
TREAS/IRS, DOL/EBSA, and HHS/CMS jointly on March 21, 2012;23
“Other Significant” Proposed Rules
In addition to the above-mentioned rules, the agencies characterized 4 of the 23 actions that were
listed in the “proposed rule” section of the Unified Agenda 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

21 U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services, “Patient Protection and
Affordable Care Act; Health Insurance Market: Rate Review,” 77 Federal Register 70584, November 26, 2012.
22 U.S. Office of Personnel Management, “Patient Protection and Affordable Care Act; Establishment of the Multi-
State Plan Program for the Affordable Insurance Exchanges,” 77 Federal Register 72581, December 5, 2012.
23 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,
“Certain Preventive Services Under the Affordable Care Act,” 77 Federal Register 16501, March 21, 2012. In the
Unified Agenda, DOL classified this action as both “major” and “economically significant.” HHS, however, classified
this action as “other significant” only. This action was not listed in the Unified Agenda by IRS.
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.
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• an HHS/CMS rule on “Minimum Essential Coverage Exemptions,” which the
agency expects to publish in January 2013, but had not yet published as of
January 14, 2013;
• an HHS/CMS rule on “Disproportionate Share Hospital Payment Reduction,”
which the agency expects to publish sometime in March 2013;
• an HHS/OCR rule on “Nondiscrimination Under the Patient Protection and
Affordable Care Act,” which the agency expects to publish sometime in March
2013; and
• a rule on “Incentives for Nondiscriminatory Wellness Programs,” which was
published as an NPRM by TREAS/IRS, DOL/EBSA, and HHS/CMS jointly on
November 26, 2012.25
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, small
governments, and small not-for-profit organizations).26 Three 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:
• a TREAS/IRS rule on “Special Rules Under the Additional Medicare Tax”;27 and
• a TREAS/IRS rule on “Reporting and Notice Requirements Under Section 6056
of the Internal Revenue Code.”
Three of the upcoming proposed rules were expected to trigger the requirements of the
Regulatory Flexibility Act because of their effects on small governments:
• an HHS/CMS rule that would establish a “Prospective Payment System for Federally
Qualified Health Centers (FQHCs)”; and
• the two TREAS/IRS rules listed above on “Special Rules Under the Additional Medicare
Tax” and “Reporting and Notice Requirements Under Section 6056.”
The TREAS/IRS rule on “Special Rules Under the Additional Medicare Tax” and the HHS/CMS
rule on “Prospective Payment System for FQHCs” were also expected to have an effect on small

25 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,
“Incentives for Nondiscriminatory Wellness Programs in Group Health Plans,” 77 Federal Register 70620, November
26, 2012.
26 For more information, see CRS Report RL32240, The Federal Rulemaking Process: An Overview, coordinated by
Maeve P. Carey.
27 U.S. Department of the Treasury, Internal Revenue Service, “Rules Relating to Additional Medicare Tax,” 77
Federal Register 72268, December 5, 2012.
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not-for-profit organizations, another potential trigger for the Regulatory Flexibility Act’s analysis
requirement.
In 11 other upcoming final rules, the agencies indicated that they had yet to determine whether a
regulatory flexibility analysis would be triggered. These rules included
• an HHS/CMS rule on “Medicaid, Exchanges, and Children’s Health Insurance
Programs: Eligibility”;
• an HHS/CMS rule on “Minimum Essential Coverage Exemptions”; and
• a TREAS/IRS rule on “Medical Loss Ratio for Section 833 Organizations.”
Timing of the Proposed Rules
The agencies indicated that 14 of the 23 items in the “proposed rule” section of the Unified
Agenda had either been published in the Federal Register or would be published in the Federal
Register by the end of December 2012. 28 As of January 14, 2013, seven items in the “proposed
rule” section had been published in the Federal Register as a notice of proposed rulemaking
(NPRM). The rules for which NPRMs have been published are
• an HHS/CMS rule on “Standards Related to Essential Health Benefits”;29
• an HHS/CMS rule on “Health Insurance Market: Rate Review”;30
• an HHS/CMS rule on “Notice of Benefit and Payment Parameters”;31
• a TREAS/IRS rule on “Special Rules Under the Additional Medicare Tax”;32
• a TREAS/IRS rule on “Fees on Health Insurance and Self-Insured Plans”;33
• an OPM rule on “Multi-State Exchanges”;34 and
• an HHS/CMS, DOL, TREAS/IRS rule on “Wellness Programs.”35

28 For a complete list of all the upcoming proposed rules listed in the Unified Agenda, their expected publication dates,
and information on when and if they were published, see the Appendix of this report.
29 U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services, “Patient Protection and
Affordable Care Act; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation,” 77 Federal
Register 70644, November 26, 2012.
30 U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services, “Patient Protection and
Affordable Care Act; Health Insurance Market: Rate Review,” 77 Federal Register 70584, November 26, 2012.
31 Department of Health and Human Services, “Notice of Benefit and Payment Parameters,” 77 Federal Register
73118, December 7, 2012.
32 U.S. Department of the Treasury, Internal Revenue Service, “Rules Relating to Additional Medicare Tax,” 77
Federal Register 72268, December 5, 2012.
33 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.
34 U.S. Office of Personnel Management, “Patient Protection and Affordable Care Act; Establishment of the Multi-
State Plan Program for the Affordable Insurance Exchanges,” 77 Federal Register 72581, December 5, 2012.
35 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,
“Incentives for Nondiscriminatory Wellness Programs in Group Health Plans,” 77 Federal Register 70620, November
26, 2012.
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The seven proposed rules that were expected to be published by the end of December 2012, but
that had not been published as of January 14, 2013, are
• an HHS/CMS rule on “Children’s Health Insurance Programs”;
• an HHS/CMS rule on “Medicare Advantage (MA) and Prescription Drug Benefit
Programs”;
• a TREAS/IRS rule on “Medical Loss Ratio for Section 833 Organizations”;
• a TREAS/IRS rule on “Health Insurance Provider Fees”;
• a TREAS/IRS rule on “Reporting and Notice Requirements Under Section 6056
of the Internal Revenue Code”;
• a TREAS/IRS rule on “Community Health Needs Assessments for Charitable
Hospitals”; and
• an HHS/CMS, DOL, TREAS/IRS rule on “Preventive Services.” 36
Several other proposed rules were expected to be issued in 2013, including
• an HHS/CMS rule on “Administrative Simplification: Compliance: Health Plan
Certification” (expected to be published in March 2013);
• an HHS/CMS rule on “Disproportionate Share Hospital Payment Reduction”
(expected to be published in March 2013);
• an HHS/CMS rule on “Prospective Payment System for Federally Qualified
Health Centers (FQHCs)(expected to be published in June 2013)”; and
• an OPM rule on “Federal Employees Health Benefits Program; Disputed Claims
and External Review Requirements” (expected to be published in March 2013).
Upcoming ACA Final Rules
The December 21, 2012, edition of the Unified Agenda listed 18 ACA-related actions in the “final
rule” section (indicating that the agencies expected to issue these final rules within the next 12
months).37 Nine of the 18 upcoming final actions are expected to be issued by components of
HHS: the Health Resources and Services Administration (HRSA, two actions); the Food and
Drug Administration (FDA, two actions); CMS (four actions); and the Office of the Secretary
(OS, one action). Three of the 18 upcoming final rules are expected to be issued by TREAS/IRS.
Two of the upcoming final rules are expected to be issued by the DOL—one each by the
Occupational Safety and Health Administration (OSHA) and the Office of Workers’

36 An advanced notice of proposed rulemaking (ANPRM), however, has been published for this rule. 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, “Certain Preventive
Services Under the Affordable Care Act,” 77 Federal Register 16501, March 21, 2012.
37 The number of “actions” listed in the Unified Agenda and reported here is not exactly the same as the number of
upcoming final rules. For example, there are two final rules listed in the Appendix as joint rules, but because the
actions in the Unified Agenda are listed by agency, the joint rules are listed once in the Unified Agenda by each
participating agency. Therefore, the 25 upcoming final actions reported here actually represent 23 final rules. The joint
rules are listed at the end of the Appendix.
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Upcoming Rules Pursuant to the Patient Protection and Affordable Care Act:

Compensation Programs (OWCP). Other final rules are expected to be issued by the Department
of Defense’s (DOD’s) Office of the Secretary (OS, one action); the Architectural and
Transportation Barriers Compliance Board (ATBCB, one action); OPM (one action); and the
Social Security Administration (SSA, one action).
Notable Final Rules
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:
• a DOD/OS rule on “Civilian Health and Medical Program of the Uniformed
Services (CHAMPUS), TRICARE Young Adult”;
• two HHS/FDA rules on “Food Labeling: Nutrition Labeling for Food Sold in
Vending Machines” and “Food Labeling: Nutrition Labeling of Standard Menu
Items in Restaurants and Similar Retail Food Establishments”; and
• an ATBCB rule on “Accessibility Standards for Medical Diagnostic Equipment.”
Economically Significant or Major Final Rules
The Unified Agenda listed five 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 fives rules are
• two HHS/FDA rules on “Food Labeling: Nutrition Labeling for Food Sold in
Vending Machines” and “Food Labeling: Nutrition Labeling of Standard Menu
Items in Restaurants and Similar Retail Food Establishments”;
• an HHS/CMS rule on “Home and Community-Based State Plan Services
Program and Provider Payment Reassignments”;
• an HHS/CMS rule on “Face-to-Face Requirements for Home Health Services;
Policy Changes and Clarifications Related to Home Health”; and
• an HHS/CMS rule on “Covered Outpatient Drugs.”
“Other Significant” Final Rules
In addition to the above-mentioned rules, nine other entries in the “final rule” section of 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 nine rules are
• a DOD/OS rule on “Civilian Health and Medical Program of the Uniformed
Services (CHAMPUS); TRICARE Young Adult”;
• an HHS/HRSA rule on “Elimination of Duplication Between the Healthcare
Integrity and Protection Data Bank and the National Practitioner Data Bank”;
• an HHS/HRSA rule on “Privacy Act Exemption for the National Practitioner
Data Bank”;
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• an HHS/CMS rule on “Federal Medicaid Assistance Percentages—
Methodologies for Calculation of Enhanced Rate”;
• an HHS/OS rule on “Health and Human Services Acquisition Regulation (HHS’
Supplement to the Federal Acquisition Regulation)”;
• a DOL/OSHA rule on “Procedures for the Handling of Retaliation Complaints
under Section 1558 of the Affordable Care Act of 2010”;
• a DOL/OWCP rule on “Regulations Implementing Amendments to the Black
Lung Benefits Act: Determining Coal Miners and Survivors Entitlement to
Benefits”;
• an ATBCB rule on “ Accessibility Standards for Medical Diagnostic Equipment”;
and
• an SSA rule on “Conforming Changes to Regulations Regarding Income-Related
Monthly Adjustment Amounts to Medicare Part B Premiums.”
Effects on Small Entities
Four 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:
• two HHS/FDA rules on “Food Labeling: Nutrition Labeling for Food Sold in
Vending Machines” and “Food Labeling: Nutrition Labeling of Standard Menu
Items in Restaurants and Similar Retail Food Establishments”;
• an HHS/CMS rule on “Covered Outpatient Drugs”; and
• a TREAS/IRS rule on “Indoor Tanning Services; Cosmetic Services Excise
Taxes.”
The two FDA rules listed above on “Food Labeling” were also expected to have an effect on
small governmental jurisdictions, another potential trigger for the Regulatory Flexibility Act’s
analysis requirement.
In four other upcoming final rules, the agencies indicated that they had yet to determine whether a
regulatory flexibility analysis would be triggered. These rules were
• an HHS/HRSA rule on “Elimination of Duplication Between the Healthcare
Integrity and Protection Data Bank and the National Practitioner Data Bank”;
• an HHS/OS rule on “Health and Human Services Acquisition Regulation (HHS’
Supplement to the Federal Acquisition Regulation)”;
• a DOL/OWCP rule on “Regulations Implementing Amendments to the Black
Lung Benefits Act: Determining Coal Miners and Survivors Entitlement to
Benefits”; and
• an ATBCB rule on “ Accessibility Standards for Medical Diagnostic Equipment.”
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Timing of Final Rules
The agencies indicated that 2 of the 18 items in the “final rule” section of the Unified Agenda
would be issued by the end of February 2013. These are
• a DOD/OS rule on “Civilian Health and Medical Program of the Uniformed
Services (CHAMPUS), TRICARE Young Adult”; and
• an HHS/CMS rule on “Federal Medicaid Assistance Percentages—
Methodologies for Calculation of Enhanced Rate.”
An additional 12 upcoming final rules are expected to be issued in the first half of 2013.
The remaining 4 rules are expected to be issued in the second half of 2013.
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 December 21, 2012, edition of the Unified Agenda listed 22 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 15 of the
22 long-term actions listed, the agencies said that the dates for the actions were “to be
determined.” Of the seven remaining long-term actions for which agencies provided an estimated
date of publication, four are expected in December 2013, two are expected in 2014, and one is
expected in 2015. The four rules that are expected in December 2013 are all TREAS/IRS 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.”
The regulatory actions expected in 2014 and 2015 are
• an HHS/CMS rule on “Medicare Shared Savings Program; Final Waivers”
(expected in 2014);
• an HHS/CMS rule on “Reporting and Returning of Overpayments” (expected in
2015); and
• a Department of Justice (DOJ)/Civil Rights Division (CRT) advance notice of
proposed rulemaking (ANPRM) on “Nondiscrimination on the Basis of
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Upcoming Rules Pursuant to the Patient Protection and Affordable Care Act:

Disability by State and Local Governments and Public Accommodations:
Accessibility of Medical Equipment and Furniture” (expected in 2014).
Notable Long-Term Actions
The agencies identified one of the ACA-related long-term actions as “economically significant”
and “major”:
• a DOL/EBSA action entitled “Group Health Plans and Health Insurance
Coverage Relating to Status as a Grandfathered Health Plan Under the Patient
Protection and Affordable Care Act.”
The agencies considered 14 of the 22 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.” These actions include
• an HHS/HRSA rule on “Designation of Medically Underserved Populations and
Health Professional Shortage Areas”;
• an HHS/HRSA rule on “340B Drug Pricing Program; Administrative Dispute
Resolution Process”; and
• 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.”
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, it is appropriate for
Congress to oversee 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 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, describing not only what rules are expected to be issued, but also providing
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 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.38
Congress, committees, and individual Members can also request that the Government
Accountability Office (GAO) evaluate the agencies’ rulemaking activities.

38 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.”
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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.”39 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.40 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.41 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)
that the agency wishes to make binding on the affected public.42 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 1 rule in the 17
years since it was enacted.43 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 of the CRA, Congress has regularly included provisions in the text of agencies’
appropriations bills in order to influence the regulatory process.44 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.45

39 Joint statement of House and Senate Sponsors, 142 Cong. Rec. E571, at E571 (daily ed. April 19, 1996); 142 Cong.
Rec. S3683, at S3683 (daily ed. April 18, 1996).
40 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.
41 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.
42 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.”
43 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.
44 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.
45 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
(continued...)
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Upcoming Rules Pursuant to the Patient Protection and Affordable Care Act:

The Appendix lists the upcoming proposed and final rules published in the 2012 Unified Agenda
in a table. 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.46 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.



(...continued)
restrictions appeared to be intended to stop particular rules issued at the end of presidential administrations.
46 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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Upcoming Rules Pursuant to the Affordable Care Act: Fall 2011 Unified Agenda

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 Unified Agenda
Publication Date
Proposed Rules
HHS/CMS Administrative
This proposed rule would implement provisions of the Affordable Care Act of 2010 under
03/2013
Simplification:
Administrative Simplification to certify that data and information systems are in compliance with any
Compliance: Health
applicable standards and associated operating rules for electronic funds transfers, eligibility for a
Note: Legal deadline
Plan Certification
health plan, health claim status, and health care payment and remittance advice.
is 12/31/2013 for first
(CMS-0037-P) (0938-
phase of compliance;
AQ85)
second phase to
occur by 12/31/2015.
HHS/CMS Patient
Protection
This final rule details standards for health insurance consistent with title I of the Affordable Care
NPRM was published
and Affordable Care
Act. Specifically, this rule outlines Exchange and issuer standards related to coverage of essential
on 11/26/2012 (77
Act; Standards
health benefits (EHB) and actuarial value (AV). This rule also proposes a timeline for qualified health
F.R. 70644).
Related to Essential
plans to be accredited in Federally-facilitated Exchanges and an amendment that provides an
Health Benefits,
application process for the recognition of additional accrediting entities for purposes of certification
Note: Legal deadline
Actuarial Value, and
of qualified health plans.
for final rule is
Accreditation (CMS-
01/01/2014.
9980-F) (0938-AR03)
HHS/CMS Medicaid,
Exchanges,
The Affordable Care Act expands access to health insurance through improvements in Medicaid, the 12/2012
and Children’s Health establishment of Affordable Insurance Exchanges (Exchanges), and coordination between Medicaid,
Insurance Programs:
the Children's Health Insurance Program (CHIP), and Exchanges. This proposed rule would continue Note: Legal deadline
Eligibility, Appeals,
our efforts to assist States in implementing Medicaid eligibility, appeals, enrollment changes, and
for final rule is
and Other Provisions
other State health subsidy programs.
01/01/2014. No
Under the Affordable
NPRM had been
Care Act (0938-
published as of
AR04)
01/14/2013.
HHS/CMS Disproportionate
This proposed rule would delineate the statutory aggregate reductions to State Medicaid
03/2013
Share Hospital
Disproportionate Share Hospital (DSH) allotments from FYs 2014 through 2020. The annual
Payment Reduction
reduction amounts would be implemented using a DSH Health Reform methodology determined by
Note: Legal deadline
(CMS-2367-P) (0938-
the Secretary.
for final rule is
AR31)
10/01/2013.
CRS-16

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Upcoming Rules Pursuant to the Affordable Care Act: Fall 2011 Unified Agenda

Department/
Expected
Agency
Title of Rule (RIN)
Abstract, as Provided in the Unified Agenda
Publication Date
HHS/CMS Patient
Protection
This final rule implements the Affordable Care Act’s policies related to fair health insurance
NPRM was published
and Affordable Care
premiums, guaranteed availability, guaranteed renewability, risk pools, and catastrophic plans. The
on 11/26/2012 (77
Act; Health Insurance rule clarifies the approach used to enforce the applicable requirements of the Affordable Care Act
F.R. 70584).
Market: Rate Review
with respect to health insurance issuers and group health plans that are non-federal governmental
(CMS-9972-F) (0938-
plans. The rule also revises the timing of the submission of requests for State-specific thresholds;
Note: Legal deadline
AR40)
revises the standards for health insurance issuers and States regarding reporting, utilization, and
for final rule is
col ection of data, and amends the requirements for a State to have an Effective Rate Review
01/01/2014.
Program.
HHS/CMS
Notice of Benefit and
Under the Affordable Care Act, this proposed rule would establish parameters of the risk
NPRM was published
Payment Parameters
adjustment, reinsurance, risk corridors, advanced premium tax credit, and cost-sharing reduction
on 12/07/2012 (77
(CMS-9964-P) (0938-
programs.
F.R. 73118).
AR51)
Note: Legal deadline
for final rule is
01/01/2014.
HHS/CMS Prospective
Payment
The Affordable Care Act amends the current Medicare FQHC payment policy by requiring the
06/2013
System for Federally
establishment of a new payment system, effective with cost reporting periods beginning on or after
Qualified Health
October 1, 2014. This rule proposes the establishment of the new prospective payment system.
Note: Legal deadline
Centers (FQHCs)
for final rule is
(CMS-1443-P)
10/01/2014.
(Section 610 Review)
(0938-AR62)
HHS/CMS Minimum
Essential
This proposed rule would implement provisions of the Affordable Care Act concerning verifications
01/2013
Coverage
of employer-sponsored coverage eligibility for the purpose of determining an individual’s eligibility
Exemptions (CMS-
for advanced premium tax credits (APTCs).
Note: Legal deadline
9958-P) (0938-AR68)
for final rule is
01/01/2014. No
NPRM had been
published as of
01/14/2013.
HHS/CMS Medicare
Advantage
Under the Affordable Care Act, this proposed rule would implement medical loss ratio
12/2012
(MA) and
requirements for the Medicare Advantage (MA) and prescription drug benefit programs.
Prescription Drug
Note: Legal deadline
Benefit Programs:
for final rule is
Medical Loss Ratio
01/01/2014. No
Requirements (CMS-
NPRM had been
4173-P) (0938-AR69)
published as of
01/14/2013.
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Upcoming Rules Pursuant to the Affordable Care Act: Fall 2011 Unified Agenda

Department/
Expected
Agency
Title of Rule (RIN)
Abstract, as Provided in the Unified Agenda
Publication Date
HHS/OCR Nondiscrimination
This proposed rule would implement prohibitions against discrimination on the basis of race, color,
03/2013
Under the Patient
national origin, sex, age, and disability, as provided in Section 1557 of the Affordable Care Act.
Protection and
Section 1557 provides certain protections from discrimination by recipients of Federal financial
Affordable Care Act
assistance, federally conducted programs, and entities established under Title I of the Affordable
(0945-AA02)
Care Act. This section also identifies additional forms of Federal financial assistance to which the
section will apply.
TREAS/IRS
Special Rules Under
Proposed amendments of Sections 31.3101, 31.3102, 31.3111, 31.3121, 1.1401, 31.6205, 31.6011,
NPRM and notice of
the Additional
31.6205, 31.6402, and 31.6413 of the Employment Tax Regulations provide guidance for employers
public hearing
Medicare Tax (1545-
and employees relating to the implementation of the Additional Medicare Tax, as enacted by the
published on
BK54)
Affordable Care Act, and correction procedures for errors related to the Additional Medicare Tax.
12/05/2012 (77 F.R.
72268).
TREAS/IRS
Fees on Health
The proposed regulations provide guidance under Sections 4375 to 4377 of the Internal Revenue
NPRM was published
Insurance and Self-
Code, as added by Section 6301 of the Patient Protection and Affordable Care Act, on fees imposed
on 12/06/2012 (77
Insured Plans (1545-
on health insurance and self-insured health plans.
F.R. 72721).
BK59)
Note: Original NPRM
and notice of public
hearing for this rule
were published on
04/17/2012 (77 F.R.
22691). The public
hearing was cancelled
on 08/09/2012 (77
F.R. 47573).
TREAS/IRS
Medical Loss Ratio
The proposed regulations will provide guidance under Section 833(c)(5) of the Internal Revenue
12/2012
for Section 833
Code, as added by Section 9016 of the Patient Protection and Affordable Care Act, on the 85%
Organizations (1545-
medical loss ratio requirement under Section 833.
Note: No NPRM had
BL05)
been published as of
01/14/2013.
TREAS/IRS Health
Insurance
The proposed regulations provide guidance on the annual fee imposed on covered entities engaged
12/2012
Provider Fees (1545-
in the business of providing health insurance for United States health risks. This fee was enacted by
BL20)
Section 9010 of the Patient Protection and Affordable Care Act (P.L. 111-148), as amended by
Note: No NPRM had
Section 10905 and further amended by Section 1406 of Health Care and Education Reconciliation
been published as of
Act of 2010 (P.L. 111-152).
01/14/2013.
TREAS/IRS
Reporting and Notice Proposed regulations under Section 6056 of the Internal Revenue Code, as enacted by the
12/2012
Requirements Under
Affordable Care Act, to provide guidance on rules that require applicable large employers to file
Section 6056 (1545-
certain information with the Internal Revenue Service on coverage under an eligible employer-
Note: No NPRM had
BL26)
sponsored health plan and furnish to individuals statements that set forth the information required
been published as of
to be reported to the Internal Revenue Service.
01/14/2013.
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Upcoming Rules Pursuant to the Affordable Care Act: Fall 2011 Unified Agenda

Department/
Expected
Agency
Title of Rule (RIN)
Abstract, as Provided in the Unified Agenda
Publication Date
TREAS/IRS Community
Health
The Notice of Proposed Rulemaking contains proposed regulations that provide guidance to
12/2012
Needs Assessments
charitable hospital organizations on the community health needs assessment requirements, and
for Charitable
related excise tax and reporting obligations, enacted in the Patient Protection and Affordable Care
Note: No NPRM had
Hospitals (1545-
Act of 2010. The proposed regulations also clarify the consequences for failing to meet these
been published as of
BL30)
requirements, as well as additional requirements related to financial assistance, charges, and billing
01/14/2013.
and collections. The proposed regulations will affect charitable hospital organizations.
OPM Federal
Employees
The U.S. Office of Personnel Management (OPM) proposes to amend the Federal Employees Group
03/2013
Group Life Insurance
Life Insurance regulations at 5 CFR part 870 to include enrollments for eligible employees of tribes
Program; Tribes and
and tribal organizations under the provisions of the Affordable Care Act of 2010.
Tribal Organizations
(3206-AM41)
OPM Federal
Employees
The U.S. Office of Personnel Management (OPM) proposes to amend the Federal Employees Health
03/2013
Health Benefits
Benefits (FEHB) regulations at 5 CFR part 890 to include enrollments for eligible employees of tribes
Program; Tribes and
and tribal organizations under the provisions of the Affordable Care Act of 2010.
Tribal Organizations
(3206-AM40)
OPM Federal
Employees
The U.S. Office of Personnel Management (OPM) proposes to amend the Federal Employees Health
03/2013
Health Benefits
Benefits (FEHB) regulations at 5 CFR part 890 to include changes to resolution of disputed health
Program; Disputed
claims and to provide for external review under the provisions of the Affordable Care Act of 2010.
Claims and External
Review
Requirements (3206-
AM42)
OPM Federal
Employees
The U.S. Office of Personnel Management (OPM) proposes to amend the Federal Employees Health
05/2013
Health Benefits
Benefits (FEHB) regulations at 5 CFR part 890 to include changes under the provisions of the
Program:
Affordable Care Act of 2010.
Miscellaneous
Changes Proposed by
the Affordable Care
Act (3206-AM46)
OPM Multi-State
The U.S. Office of Personnel Management (OPM) is proposing regulations for the implementation of
NPRM was published
Exchanges;
provisions of the Affordable Care Act of 2010 that will enable OPM to contract with at least two
on 12/05/2012 (77
Implementations for
multi-State plans for the Affordable Insurance Exchanges to be offered in 2014.
F.R. 72581).
Affordable Care Act
Provisions (3206-
AM47)
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Upcoming Rules Pursuant to the Affordable Care Act: Fall 2011 Unified Agenda

Department/
Expected
Agency
Title of Rule (RIN)
Abstract, as Provided in the Unified Agenda
Publication Date
TREAS/IRS,
Group Health Plans
The Patient Protection and Affordable Care Act of 2010 (the Affordable Care Act) amended Title I
12/2012, 02/2013
DOL/EBSA,
and Health Insurance
of the Employee Retirement Income Security Act (ERISA), by adding a new Section 715 which
HHS/CMS, jointly
Issuers Relating to
encompasses various health reform provisions of the Public Health Service Act. These regulations
Note: ANPRM was
Coverage of
provide guidance on the rules relating to coverage of preventive services without cost sharing under
published on
Preventive Services
the Affordable Care Act. As mentioned in previous requests, RIN 1210-AB41 was split into
03/21/2012 (77 F.R.
Under the Patient
additional RINs due to the breadth of issues covered, and this is the fourth request in a series
16501). DOL/EBSA
Protection and
relating to the Affordable Care Act.
listed an expected
Affordable Care Act
publication date of
(CMS-9968-P) (1210-
12/2012. HHS/CMS’s
AB44), (0938-AR42)
expected publication
date was 02/2013.
TREAS/IRS,
Incentives for
The Patient Protection and Affordable Care Act of 2010 (the Affordable Care Act) amended Title I
NPRM was published
DOL/EBSA,
Nondiscriminatory
of ERISA, by adding a new Section 715 which encompasses various health reform provisions of the
on 11/26/2012 (77
HHS/CMS, jointly
Wellness Programs in Public Health Service Act. These regulations provide guidance on wellness programs.
F.R. 70620).
Group Health Plans
(CMS-9979-F) (1210-
AB55), (0938-AR48)
Final Rules



DOD/OS
Civilian Health and
This interim final rule implements Section 702 of the Ike Skelton National Defense Authorization
02/2013
Medical Program of
Act for Fiscal Year 2011 (NDAA for FY2011). It establishes the TRICARE Young Adult (TYA)
the Uniformed
program to provide an extended medical coverage opportunity to most unmarried children under
Note: Originally
Services
the age of 26 of uniformed services sponsors. The TRICARE Young Adult program is a premium-
published as an
(CHAMPUS);
based program.
interim final rule on
TRICARE Young
04/27/2011 (76 F.R.
Adult (0720-AB48)
23479). Legal
deadline for final rule
was 01/01/2011.
HHS/HRSA Elimination
of
This final rule, required by the Affordable Care Act, eliminates the redundant reporting
03/2013
Duplication Between
requirements for two closely related national health care data banks. It terminates the Healthcare
the Healthcare
Integrity and Protection Data Bank (HIPDB) and transfers all data collected in the HIPDB to the
Note: NPRM was
Integrity and
National Practitioner Data Bank (NPDB). It also provides for the disclosure of information, fee
published on
Protection Data Bank col ection, and establishment of dispute procedures.
02/15/2012 (77 F.R.
and the National
9138). The Unified
Practitioner Data
Agenda indicated that
Bank (0906-AA87)
there is a statutory
deadline, but did not
specify what the
deadline is.
CRS-20

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Upcoming Rules Pursuant to the Affordable Care Act: Fall 2011 Unified Agenda

Department/
Expected
Agency
Title of Rule (RIN)
Abstract, as Provided in the Unified Agenda
Publication Date
HHS/HRSA Privacy
Act This interim final rule will exempt the system of records for the National Practitioner Data Bank
09/2013
Exemption for the
(NPDB) from certain provisions of the Privacy Act (5 U.S.C. 552a). The exemption will be necessary
National Practitioner
when the two data banks, the Healthcare Integrity and Protection Data Bank (HIPDB) and the
Data Bank (0906-
NPDB, merge as required by Section 6403 of the Affordable Care Act. As a result, the NPDB will
AA97)
include the investigative materials compiled for law enforcement purposes reported to the HIPDB.
The system of records for the HIPDB has an exemption (45 CFR 5b.11(b)(2)(i )(F)) from certain
provisions of the Privacy Act. In order to maintain the exemption for the investigative materials, it is
necessary to amend the regulatory language to expand the same privacy act exemptions for the
HIPDB to the NPDB.
HHS/FDA Food
Labeling:
The Food and Drug Administration (FDA) published a proposed rule in the Federal Register of April
04/2013
Nutrition Labeling for 6, 2011 (72 FR 19238) to establish requirements for nutrition labeling of certain food items sold in
Food Sold in Vending
certain vending machines. FDA also proposed the terms and conditions for vending machine
Note: NPRM was
Machines (0910-
operators registering to voluntarily be subject to the requirements. FDA took this action to carry
published on
AG56)
out Section 4205 of the Patient Protection and Affordable Care Act (Affordable Care Act or ACA),
04/06/2011 (76 F.R.
which was signed into law on March 23, 2010.
19238).
HHS/FDA Food
Labeling:
The Food and Drug Administration (FDA) published a proposed rule in the Federal Register of April
04/2013
Nutrition Labeling of
6, 2011 (72 FR 19192), to establish requirements for nutrition labeling of standard menu items in
Standard Menu Items
chain restaurants and similar retail food establishments. FDA also proposed the terms and
Note: NPRM was
in Restaurants and
conditions for restaurants and similar retail food establishments registering to voluntarily be subject
published on
Similar Retail Food
to the Federal requirements. FDA took this action to carry out Section 4205 of the Patient
04/06/2011 (76 F.R.
Establishments (0910-
Protection and Affordable Care Act (Affordable Care Act or ACA), which was signed into law on
19192).
AG57)
March 23, 2010.
HHS/CMS Home
and This final rule amends the Medicaid regulations to define and describe State plan home and
05/2013
Community-Based
community-based services (HCBS) under the Affordable Care Act. This rule offers States flexibilities
State Plan Services
in providing necessary and appropriate services to elderly and disabled populations.
Note: Original NPRM
Program and
was published on
Provider Payment
04/04/08 (73 F.R.
Reassignments (CMS-
18676). Following
2249-F) (0938-AO53)
enactment of ACA, a
second NPRM was
published on
05/03/2012 (77 F.R.
26362). Under the
Deficit Reduction Act
of 2005 (P.L. 109-71),
the original legal
deadline for final rule
was 01/01/2007.
CRS-21

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Upcoming Rules Pursuant to the Affordable Care Act: Fall 2011 Unified Agenda

Department/
Expected
Agency
Title of Rule (RIN)
Abstract, as Provided in the Unified Agenda
Publication Date
HHS/CMS Face-to-Face
This final rule revises the Medicaid home health service definition as required by Section 6407 of the
05/2013
Requirements for
Affordable Care Act of 2010 to add a requirement that physicians document the existence of a face-
Home Health
to-face encounter (including through the use of telehealth) with the Medicaid eligible individual
Note: NPRM was
Services; Policy
within reasonable timeframes. In addition, this rule amends home health services regulations to
published on
Changes and
clarify the definitions of included medical supplies, equipment and appliances, and clarify that States
07/12/2011 (76 F.R.
Clarifications Related
may not limit home health services to services delivered in the home, or to services furnished to
41032).
to Home Health
individuals who are homebound.
(CMS-2348-F) (0938-
AQ36)
HHS/CMS Covered
Outpatient
This final rule revises requirements pertaining to Medicaid reimbursement for covered outpatient
08/2013
Drugs (CMS-2345-F)
drugs to implement provisions of the Affordable Care Act. This rule also revises other requirements
(0938-AQ41)
related to covered outpatient drugs, including key aspects of Medicaid coverage, payment, and the
Note: NPRM was
drug rebate program.
published on
02/02/2012 (77 F.R.
5318).
HHS/CMS Federal
Medicaid
The Affordable Care Act authorizes enhanced Federal Medical Assistance Percentages (FMAP) for
02/2013
Assistance
newly eligible individuals as defined by the act. This rule finalizes a section of the proposed rule
Percentages—
published on August 17, 2011, that set forth methodologies for FMAP calculations.
Note: This final rule
Methodologies for
will finalize only a
Calculation of
section of the NPRM
Enhanced Rate (CMS-
that was published on
2327-F) (0938-AR38)
08/17/2011 (76 F.R.
51148). Legal
deadline for final rule
is 01/01/2014.
HHS/OS
Health and Human
This interim final rule amends the Department’s Federal Acquisition Regulation (FAR) Supplement—
03/2013
Services Acquisition
the HHS Acquisition Regulation (HHSAR)—to provide implementation guidance for provisions in
Regulation (HHS’
the HHS FY2012 Appropriations Acts and to establish HHS’ non-discrimination policy.
Supplement to the
Federal Acquisition
Regulation) (0991-
AB88)
CRS-22

---

Upcoming Rules Pursuant to the Affordable Care Act: Fall 2011 Unified Agenda

Department/
Expected
Agency
Title of Rule (RIN)
Abstract, as Provided in the Unified Agenda
Publication Date
DOL/OSHA
Procedures for the
OSHA is proposing to promulgate procedures for the handling and investigation of retaliation
03/2013
Handling of
complaints pursuant to Section 1558 of the Patient Protection and Affordable Care Act of 2010 (the
Retaliation
Affordable Care Act or ACA). This section established a new whistleblower protection statute to
Complaints under
be administered by OSHA that provides protection from retaliation to employees in the health care
Section 1558 of the
industry who engage in protected activities under the ACA. Pursuant to the statute, the procedures
Affordable Care Act
will follow those enacted under the Consumer Product Safety Improvement Act, 15 U.S.C. 2087(b),
of 2010 (1218-AC79)
including remedies and legal burdens of proof provisions. Promulgation of a regulation is necessary
to govern whistleblower investigations conducted under the new statute.
DOL/OWCP Regulations The Patient Protection and Affordable Care Act (PPACA) of 2010 amended the Black Lung Benefits
09/2013
Implementing
Act, 30 U.S.C. 901 to 944, to reinstate two methods of establishing entitlement that were repealed
Amendments to the
with respect to claims filed after 1981. Specifically, the PPACA reinstated 30 U.S.C.
Note: NPRM was
Black Lung Benefits
921(c)(4)(presumption of total disability or death due to pneumoconiosis arising out of coal mine
published on
Act: Determining
employment where the miner had 15 years of coal mine employment and proof of total disability)
03/30/2012 (77 F.R.
Coal Miners and
and 30 U.S.C. 932(l) (automatic entitlement to benefits for eligible survivors of miners who were
19456).
Survivors Entitlement awarded benefits based on lifetime claims). The newly amended statutory provisions apply to claims
to Benefits (1240-
filed after January 1, 2005, that are pending on or after PPACA’s March 23, 2010, enactment date,
AA04)
and to all claims filed on or after March 23, 2010. This final rule will define the class of claims
affected by the amendments and set the criteria for establishing entitlement to benefits under the
amendments.
TREAS/IRS Branded
Prescription
Implementation of Section 9008 applies to imposition of annual fee on branded prescription
04/2013
Drug Fee (1545-BJ39) pharmaceutical manufacturers and importers, of the Patient Protection and Affordable Care Act of
2010, P.L. 111-148.
Note: NPRM was
published on
08/18/2011 (76 F.R.
51310).
TREAS/IRS Indoor
Tanning
Proposed regulations provide guidance on the indoor tanning services tax made by the Patient
06/2013
Services; Cosmetic
Protection and Affordable Care Act of 2010, affecting users and providers of indoor tanning
Services Excise
services.
Note: NPRM was
Taxes (1545-BJ40)
published on
06/15/2012 (75 F.R.
33740). IRS held a
public hearing on
10/11/2011 (notice of
the hearing was
published on
08/03/2011; see 76
F.R. 46677).
CRS-23

---

Upcoming Rules Pursuant to the Affordable Care Act: Fall 2011 Unified Agenda

Department/
Expected
Agency
Title of Rule (RIN)
Abstract, as Provided in the Unified Agenda
Publication Date
TREAS/IRS Requirements
for
These proposed regulations provide guidance requiring coverage of certain preventive health
04/2013
Group Health Plans
services without cost-sharing under Section 2713 of the Public Health Service Act, incorporated into
and Health Insurance
Section 9815 of the Internal Revenue Code by Section 1563(f) of the Patient Protection and
Note: NPRM was
Issuers Relating to
Affordable Care Act, P.L. 111-148.
published on
Coverage of
07/19/2010 (75 F.R.
Preventive Services
41787). A second
Under the Patient
NPRM was published
Protection and
on 08/03/2011 (76
Affordable Care
F.R. 46677).
Act (1545-BJ58)
ATBCB Accessibility
This regulation will establish minimum technical criteria to ensure that medical equipment used for
11/2013
Standards for Medical diagnostic purposes by health professionals in (or in conjunction with) physician’s offices, clinics,
Diagnostic
emergency rooms, hospitals, and other medical settings is accessible to and usable by individuals
Note: Public
Equipment (3014-
with disabilities.
information meeting
AA40)
was held on
07/29/2010 (see
notice published 75
F.R. 35439); NPRM
published on
02/09/2012 (77 F.R.
6916); notice of
intent to form
advisory committee
published on
03/13/2012 (77 F.R.
14706).
OPM Federal
Employees
The U.S. Office of Personnel Management (OPM) will publish a final rule to amend the Federal
03/2013
Health Benefits
Employees Health Benefits (FEHB) regulations at 5 CFR Part 890 to include changes pertaining to
Program:
the Affordable Care Act in regards to age 26 and children of same-sex partners.
Note: NPRM was
Miscellaneous
published on
Changes (3206-
07/20/2012 (77 F.R.
AM55)
42914).
CRS-24

---

Upcoming Rules Pursuant to the Affordable Care Act: Fall 2011 Unified Agenda

Department/
Expected
Agency
Title of Rule (RIN)
Abstract, as Provided in the Unified Agenda
Publication Date
SSA Conforming
Changes
We are modifying our regulations to the Medicare Part B income-related monthly adjustment
06/2013
to Regulations
amount (IRMAA) in order to conform to changes made to the Social Security Act (Act) by the
Regarding Income-
Affordable Care Act. These rules remove the requirement that beneficiaries consent to the release
Related Monthly
of IRS information outside of SSA for appeals past the reconsideration level and freeze the income
Adjustment Amounts
threshold and ranges from 2011 through 2019. We are also removing provisions that phased in the
to Medicare Part B
income-related monthly adjustment amount between 2007 and 2009. The regulation also updates an
Premiums (0960-
outdated provision to reflect the transfer of authority for hearing appeals under Title XVIII of the
AH47)
act from SSA to the Department of Health and Human Services, as prescribed by the Medicare
Prescription Drug, and Modernization Act of 2003.
Source: Information in the first three columns is verbatim as reported in the Unified Agenda of Federal Regulatory and Deregulatory Actions, December 21, 2012,
available at http://www.reginfo.gov/public/do/eAgendaMain. Information in the fourth column is from the Unified Agenda and the Federal Register.
Note: The table includes only those Unified Agenda entries in which the Affordable Care Act was mentioned.
CRS-25

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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

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