Upcoming Rules Pursuant to the Patient Protection and Affordable Care Act: The Spring 2014 Unified Agenda
Released: 2014-06-30T00:00:00

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. 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.

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 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.

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. 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.

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." 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 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. The previously referenced CRS report identifying the provisions in the act that require or permit rulemaking can be useful in this regard.

The Unified Agenda

A potentially effective way for Congress to identify upcoming ACA rules is by reviewing the Unified Agenda of Federal Regulatory and Deregulatory Actions (hereafter Unified Agenda), which is usually published twice each year—in the spring and fall. 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). 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. 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." 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 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), 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).

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 most systematic, government-wide method to alert the public about their upcoming proposed rules.

Scope and Methodology of This Report

The Spring 2014 edition of the Unified Agenda, published on May 23, 2014, is the seventh edition compiled and issued by RISC since enactment of the ACA. Federal agencies are usually required to submit data to RISC several weeks prior to publication, but some items may have been subsequently updated during the OIRA review process.

This report examines the Spring 2014 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 14 proposed rules and 17 final rules they expect to issue pursuant to the ACA within the next 12 months. Agencies also reported a total of four 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. 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.

Upcoming ACA Proposed Rules

The Spring 2014 edition of the Unified Agenda listed 14 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). Ten of the 14 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, four rules); the Office of Inspector General (OIG, three rules); the Health Resources and Services Administration (HRSA, one rule); the Office for Civil Rights (OCR, one rule); and the Administration for Children and Families (ACF, one rule). Two other proposed rules were expected to be issued by the Equal Employment Opportunity Commission (EEOC). The final two proposed rules are to be issued jointly by CMS, the Department of Labor's (DOL) Employee Benefits Security Administration (EBSA), and the Department of the Treasury's (TREAS) Internal Revenue Service (IRS).

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 were 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. In the spring edition, agencies are asked to indicate whether their rules have appeared in the regulatory plan. However, of the proposed rules included in the Spring 2014 Unified Agenda, none had been included in the regulatory plan.

"Economically Significant" or "Major" Proposed Rules

Although none of the proposed rules were listed in the regulatory plan, the Unified Agenda listed three rules that were considered "economically significant" and/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). All three rules are to be issued by CMS:

a rule on "Reform of Requirements for Long-Term Care Facilities and Quality Assurance and Performance Improvement (QAPI) Program"; a rule on "CY 2016 Notice of Benefit and Payment Parameters"; and a rule on "Application of the Mental Health Parity and Addiction Equity Act to Medicaid Programs."

"Other Significant" Proposed Rules

In addition to the above-mentioned rules, the agencies characterized 9 of the 14 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:

an HHS/OIG rule on "Medicare and State Health Care Programs: Fraud and Abuse; Revisions to the Office of Inspector General's Civil Monetary Penalty Rules"; an HHS/OIG rule on "Fraud and Abuse; Revisions to the Office of Inspector General's Exclusion Authorities"; an HHS/CMS rule on "State Option To Provide Health Homes for Enrollees With Chronic Conditions"; an HHS/OCR rule on "Nondiscrimination Under the Patient Protection and Affordable Care Act"; an HHS/ACF rule on "Refugee Medical Assistance"; an EEOC rule on "Amendments to Regulations Under the Americans With Disabilities Act"; an EEOC rule on "Amendments to Regulations Under the Genetic Information Nondiscrimination Act of 2008"; an HHS/CMS, DOL/EBSA, and TREAS/IRS rule on "Ninety-Day Waiting Period Limitation"; and an HHS/CMS, DOL/EBSA, and TREAS/IRS rule on "Amendments to Excepted Benefits."

Effects on Small Entities

The Regulatory Flexibility Act (RFA, 5 U.S.C. §§601-612) 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). Six of the ACA-related rules listed in the proposed rule section expected that they may trigger the requirements of the Regulatory Flexibility Act because of their effects on small entities:

an HHS/CMS rule on "Reform of Requirements for Long-Term Care Facilities and Quality Assurance and Performance Improvement (QAPI) Program"; an HHS/CMS rule on "Application of the Mental Health Parity and Addiction Equity Act to Medicaid Programs"; an EEOC rule on "Amendments to Regulations Under the Americans With Disabilities Act"; an EEOC rule on "Amendments to Regulations Under the Genetic Information Nondiscrimination Act of 2008"; an HHS/CMS, DOL/EBSA, and TREAS/IRS rule on "Amendments to Excepted Benefits"; and an HHS/CMS, DOL/EBSA, and TREAS/IRS rule on "Ninety-Day Waiting Period Limitation."

Timing of the Proposed Rules

As of June 19, 2014, four proposed rules listed in the Unified Agenda had been published in the Federal Registe r :

an HHS/OIG rule on "Medicare and State Health Care Programs: Fraud and Abuse; Revisions to the Office of Inspector General's Civil Monetary Penalty Rules"; an HHS/OIG rule on "Fraud and Abuse; Revisions to the Office of Inspector General's Exclusion Authorities"; an HHS/CMS, DOL/EBSA, and TREAS/IRS rule on "Ninety-Day Waiting Period Limitation Under the Affordable Care Act"; and an HHS/CMS, DOL/EBSA, and TREAS/IRS rule on "Amendments to Excepted Benefits."

An additional three upcoming proposed rules were expected to be issued in May or June 2014, but had not yet been issued as of June 19, 2014:

an HHS/CMS rule on "Reform of Requirements for Long-Term Care Facilities and Quality Assurance and Performance Improvement (QAPI) Program"; an EEOC rule on "Amendments to Regulations Under the Americans With Disabilities Act"; and an EEOC rule on "Amendments to Regulations Under the Genetic Information Nondiscrimination Act of 2008."

The remaining proposed rules listed in the Unified Agenda are expected to be issued sometime during the remaining months of 2014 or 2015.

Upcoming ACA Final Rules

The Spring 2014 edition of the Unified Agenda listed 17 upcoming rules in the final rule section (indicating that the agencies expected to issue these final rules within the next 12 months). Eleven of the 17 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); and CMS (eight rules). Three of the 17 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); and the Department of Veterans Affairs (VA, one rule).

Notable Final Rules

As discussed 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

Three of the ACA regulations that were listed in the final rule section of the Unified Agenda had been considered important enough to be included in the agencies' regulatory plans:

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 June 2014; an ATBCB rule on "Accessibility Standards for Medical Diagnostic Equipment," which the agency expects to publish in November 2014.

"Economically Significant" or "Major" Final Rules

The Unified Agenda listed seven entries in the final rule section that were considered "economically significant" and/or "major" (i.e., that were expected to have at least a $100 million annual effect on the economy):

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 June 2014; 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 June 2014; 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," which the agency published as a final rule with comment period on May 2, 2014; an HHS/CMS rule on "Adoption of Operating Rules for HIPAA Transactions," which the agency expects to publish as an interim final rule in March 2015; and an HHS/CMS rule on "Eligibility Notices, Fair Hearing and Appeal Processes for Medicaid and Exchange Eligibility Appeals, and Other Eligibility and Enrollment Provisions," which the agency expects to publish in November 2014.

"Other Significant" Final Rules

In addition to the above-mentioned rules, six additional 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:

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 October 2014; an HHS/CMS rule on "Reporting and Returning of Overpayments," which the agency expects to publish in February 2015; an HHS/CMS rule on "Medicare Shared Savings Program; Final Waivers," which the agency expects to publish in November 2014; an HHS/CMS rule on "Patient Protection and Affordable Care Act; Third Party Payment of Qualified Health Plan (QHP) Premiums," which the agency published as an interim final rule on March 19, 2014; 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 February 2015; and an ATBCB rule on "Accessibility Standards for Medical Diagnostic Equipment," which the agency expects to publish in November 2014.

Effects on Small Entities

Four of the upcoming final rules indicated they are likely to have effects on small entities (businesses, governments, and/or not-for-profit organizations) as defined by the Regulatory Flexibility Act (RFA, 5 U.S.C. §602), possibly triggering the requirements of the RFA:

an HHS/CMS rule on "Reporting and Returning of Overpayments"; an HHS/CMS rule on "Medicare Shared Savings Program; Final Waivers"; an HHS/CMS rule on "Eligibility Notices, Fair Hearing and Appeal Processes for Medicaid and Exchange Eligibility Appeals, and Other Eligibility and Enrollment Provisions"; and an HHS/CMS rule on "Patient Protection and Affordable Care Act; Third Party Payment of Qualified Health Plan (QHP) Premiums."

Timing of Final Rules

Two of the rules listed in the final rule section of the Unified Agenda had been published as of June 19, 2014:

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"; and an HHS/CMS rule on "Patient Protection and Affordable Care Act; Third Party Payment of Qualified Health Plan (QHP) Premiums."

An additional five upcoming final rules were expected to be issued in May or June 2014, but had not yet been issued as of June 19, 2014:

an HHS/FDA rule on "Food Labeling: Calorie Labeling of Articles of Food Sold in Vending Machines"; an HHS/FDA rule on "Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments"; an HHS/CMS rule on "Covered Outpatient Drugs"; a TREAS/IRS rule on "Branded Prescription Drug Fee"; and a TREAS/IRS rule on "Requirement of a Section 4959 Excise Tax Return and Time for Filing the Return."

The remaining final rules listed in the Unified Agenda are expected to be issued sometime during 2014 or 2015.

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 that the agencies do not expect to take action on in the next 12 months). The Spring 2014 edition of the Unified Agenda listed four long-term actions related to the 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 each of the four 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."

Notable Long-Term Actions

None of the rules in the long-term actions section were considered "major" or "economically significant." The agencies considered two of the four actions to be "other significant," meaning that the agencies considered them significant enough to be reviewed by OIRA under Executive Order 12866, but they were not expected to be "economically significant":

an HHS/HRSA rule on "340B Drug Pricing Program; Administrative Dispute Resolution Process"; and a DOL/EBSA "undetermined" action on "Automatic Enrollment in Health Plans of Employees of Large Employers Under FLSA Section 18A."

Effects on Small Entities

None of the long-term actions indicated they expected to have an effect on small entities. However, that could be because of the preliminary nature of the rules included in that section.

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 what rules are being issued—ideally as early as possible. The Unified Agenda is perhaps the best vehicle to provide that early information, as it describes the rules that 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. Congress may conduct 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. 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." The CRA generally requires federal agencies to submit all of their covered final rules to both houses of Congress and GAO before they can take effect. 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. 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 makes binding on the affected public. 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. 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. 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.

This report's Appendix contains a table listing the upcoming proposed and final rules published in the Spring 2014 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. 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.

Appendix. Upcoming Proposed and Final Rules Pursuant to the Patient Protection and Affordable Care Act (ACA)