DEPARTMENT OF HEALTH AND HUMAN SERVICES

Statement of Regulatory Priorities for Fiscal Year 2013

The Department of Health and Human Services (HHS) is the Federal Government's principal agency charged with protecting the health of all Americans and providing essential human services, especially for those least able to help themselves. The Department operates more than 300 programs covering a wide spectrum of activities, manages almost a quarter of all Federal expenditures, and administers more grant dollars than all other Federal agencies combined. In fiscal year 2013, HHS agencies will continue to implement programs that strengthen the health care system; advance scientific knowledge and innovation; advance the health, safety, and well-being of the American people; increase efficiency, transparency, and accountability of HHS programs; and strengthen the nation's health and human services infrastructure and workforce.

To carry out its mission, the Department develops an ambitious regulatory agenda each year. HHS actively encourages public participation in the regulatory process and is currently engaging in a Department-wide effort to identify ways to make the rulemaking process more accessible to the general public. Incorporating this feedback, Secretary Kathleen Sebelius has worked with HHS agencies to identify opportunities to streamline regulations and reduce the regulatory burden on industry and states; secure and maintain health care coverage for all Americans; take advantage of technology to promote health care innovation and rapidly respond to adverse events; implement a 21st century food safety system; promote children's health and well-being; and arm consumers with information to help them make healthy choices.

This overview outlines the Department's regulatory priorities for FY 2013 and some of the regulations on the agenda that best exemplify these priorities.

Streamlining Regulations to Reduce Regulatory Burdens

Consistent with the President's Executive Order 13563, "Improving Regulation and Regulatory Review," the Department remains committed to reducing regulatory burden on states, health care providers and suppliers, and other regulated industries by eliminating outdated procedures, streamlining rules, and providing flexibility to use technology.

- The Centers for Medicare & Medicaid Services (CMS) has an ambitious effort underway to reduce burdens on hospitals and other health care providers and save providers money and time so that they can focus their resources on caring for patients. In May 2012, CMS finalized two rules--addressing the Medicare conditions of participation for hospitals and critical access hospitals (CAH) (0938-AQ89) and regulatory requirements for a broader range of health care providers and suppliers regulated under Medicare and Medicaid (0938-AQ96) - that will save approximately $1.1 billion across the health care system in just the first year while reducing unnecessary burdens on hospitals and other health care providers. For the second phase of this effort, CMS will issue regulations that will eliminate or streamline Medicare rules and requirements that are unnecessary, obsolete, or excessively burdensome to health care professionals and patients.¹ This effort will allow health care professionals to devote more time and effort to improving patient care.

- The Food and Drug Administration (FDA) will finalize amendments to its medical device reporting regulations to require manufacturers and importers to submit electronic reports of individual medical device adverse events to the agency.² This will help move the medical device industry from paper to electronic reporting, which will reduce paperwork burden on industry and increase the speed at which FDA processes critical information.

- In a major undertaking, the Department and White House Office of Science and Technology Policy are reviewing and considering making revisions to the ethical rules governing research on human subjects, often referred to as the Common Rule.³ The Common Rule governs institutions and researchers supported by HHS, and researchers throughout much of the Federal Government, in the conduct of research on humans. The proposed revisions will aim to better protect human subjects who are involved in research while facilitating research and reducing burden, delay, and ambiguity for investigators.

- The Administration for Children and Families (ACF) will propose reforms to its child support regulations that will simplify program operations, clarify technical provisions in the existing rules, and allow States and tribes to take advantage of advances in technology and move toward electronic communication with ACF and with other States and tribes.⁴ These reforms will create more efficient child support systems that better serve families in need of this crucial financial support.

Strengthening Medicare and Expanding Coverage in the Private Health Care Market

The Department continues to implement Affordable Care Act provisions that expand health insurance coverage and ensure that the American people can rely on their existing coverage when they need it most. Millions of Americans--including women, families, seniors, and small business owner--are already benefitting from the Affordable Care Act. In June, HHS announced that 12.8 million Americans will benefit from $1.1 billion in rebates from insurance companies, as a result of HHS regulations that require insurers to spend the majority of health insurance premiums on medical care and health care quality improvement, instead of administration and overhead.⁵ As well, the Affordable Care Act has provided $4.8 billion in reinsurance payments to employers and other sponsors of early retiree health coverage to help them continue to provide health benefits to retired workers who are not yet eligible for Medicare and to the families of these retired workers. At least 19 million retirees and their family members have already benefitted or will benefit from this program. Because of another Affordable Care Act provision, approximately 54 million Americans with private health insurance and 32.5 million seniors with Medicare received at least one free preventive service from their health care provider in 2011.⁶ And as of August 1, 2012, about 47 million women will be able to receive preventive care such as mammograms, cervical cancer screenings, and annual preventive care visits without paying co-pays or deductibles.⁷

Building on those efforts, HHS will provide guidance this year to States, providers, and insurers that are preparing for the reforms to the health care marketplace that become effective in 2014.

- The Department will finalize a rule that outlines standards for the state-run and federally-facilitated Affordable Insurance Exchanges, which will provide competitive marketplaces for individuals and small employers to directly compare available private health insurance options on the basis of price and quality. These standards will ensure, for example, that individual and small group plans provide certain levels of coverage. This means that consumers can rest assured that plans inside and outside of the Exchanges will cover certain essential health benefits. ⁸

- The Department will also implement provisions of the Affordable Care Act that set the rules for risk adjustment, reinsurance, risk corridors, advanced premium tax credits, and cost-sharing reductions.⁹

- Another final rule would outline many of the consumer protections at the heart of the Affordable Care Act.¹⁰ These new health insurance market standards will promote access to, and the affordability of, health insurance coverage by extending new guaranteed availability rights to individuals and employers, continuing current guaranteed renewability protections, specifying a limited, transparent set of factors that can be used to set premiums, and requiring broader pooling of insurance risk. This rule, in tandem with rules implementing Affordable Care Act provisions that establish Exchanges; provide tax credits to certain individuals and employers for purchasing health insurance coverage; and create the risk adjustment, reinsurance, and risk corridor programs; lays the foundation for a more affordable, better-functioning insurance market.

- Another rule would implement provisions of the Affordable Care Act that expand access to health insurance through Medicaid, the establishment of the Affordable Insurance Exchanges, and coordination between Medicaid, the Children's Health Insurance Program (CHIP), and the Exchanges. This proposed rule would continue CMS's efforts to assist States in implementing changes to the eligibility, appeals, and enrollment under Medicaid and other State health subsidy programs.¹¹

- In addition, CMS will update several Medicare provider payment rules in ways that strengthen Medicare, better reflect the state of practice, and are responsive to feedback from providers. ¹² These rules, which are published annually, provide predictability for health care providers so they can manage their finances appropriately.

- Finally, CMS will implement the Affordable Care Act provision that establishes a new prospective payment system for Federally Qualified Health Centers (FQHCs), which are facilities that provide primary care services to underserved urban and rural communities.¹³ This rule will bring the FQHC payment system in line with the payment procedure for the majority of Medicare providers and will allow FQHCs to anticipate future reimbursements for providing services to Medicare beneficiaries.

Advancing Innovation to Improve Consumer Health and Safety

Through administrative reforms, innovations, and providing additional information to support consumer decision-making, HHS is supporting high-value, safe, and effective care across health care settings and in the community. For example, FDA will issue a Unique Device Identifier final rule to establish a unique identification system for medical devices to track a device from pre-market application through distribution and use. This system will allow FDA and other public health professionals to track individual devices so that when an adverse event occurs, epidemiologists can quickly track down and identify other users of the device to provide guidance and recommendations on what steps to take to prevent additional medical errors.¹⁴

As discussed previously, FDA is also amending its post-marketing medical device reporting regulations to require manufacturers and importers to submit electronic reports of individual medical device adverse events to the Agency. These electronic submissions will help FDA receive information about malfunctioning devices quickly and will enhance the Agency's ability to collect and analyze data from these adverse events. In addition to providing the Agency with this information soon after an adverse event occurs, this final rule is expected to result in significant burden reductions in reporting and recordkeeping for device manufacturers and suppliers.¹⁵

Implementing a 21^st Century Food Safety System

FDA will continue its work to implement the Food Safety Modernization Act, working with public and private partners to build a new system of food safety oversight. In implementing that Act, the Department is focusing on applying the best available science and lessons from previous outbreaks to shift the Agency's emphasis from recalling unsafe products from the market place to preventing unsafe food from entering commerce in the first place. FDA will propose several new rules to establish a robust, enhanced food safety program.

- FDA will propose regulations establishing preventive controls in the manufacture and distribution of human foods¹⁶ and of animal feeds.¹⁷ These regulations constitute the heart of the food safety program by instituting uniform practices for the manufacture and distribution of food products to ensure that those products are safe for consumption and will not cause or spread disease.

- FDA will continue its work on a rule to ensure that produce sold in the United States meets rigorous safety standards.¹⁸ The regulation will set enforceable, science-based standards for the safe production and harvesting of fresh produce at the farm and the packing house to minimize the risk of serious adverse health consequences.

- In another proposed rule, FDA will require food importers to establish a verification program to improve the safety of food that is imported into the United States.¹⁹ Specifically, the FDA will outline proposed standards that foreign food suppliers must meet to ensure that imported food is produced in a manner that is as safe as food produced in the United States.

- FDA will also establish a program to accredit third-party auditors to conduct audits of foreign food suppliers.²⁰ This program will allow importers to contract with an accredited auditor to meet the audit requirements instead of having to establish such programs themselves.

Promoting Children's Health and Well-being

ACF's regulatory portfolio includes several rules that promote children's health and well-being. For example, one proposed rule would provide the first comprehensive update of Child Care and Development Fund (CCDF) regulations since 1998.²¹ The CCDF is a Federal program that provides formula grants to States, territories, and tribes. The program provides financial assistance to low-income families to access child care so that they can work or attend a job training or educational program. It also provides funding to improve the quality of child care and increase the supply and availability of care for all families, including those who receive no direct assistance through CCDF. The proposed rule would make improvements in four key areas: (1) health and safety; (2) child care quality; (3) family-friendly policies that promote continuity of care and support working families; and (4) program integrity. These proposed changes reflect current research and knowledge about the early care and education sector, State innovations in policies and practices over the past decade, and increased recognition that high quality child care both supports work for low-income parents and promotes children's learning and healthy development. The rule is responsive to the need for State flexibility in administering the CCDF program.

Empowering Americans to Make Healthy Choices in the Marketplace

As of 2010, more than one-third of U.S. adults²² and 17% of all children and adolescents²³ in the United States are obese, representing a dramatic increase in the rise of this health status. Since 1980, the prevalence of obesity among children and adolescents has almost tripled.²⁴ Obesity has both immediate and long-term effects on the health and quality of life of those affected, increasing their risk for chronic diseases, including heart disease, type 2 diabetes, certain cancers, stroke, and arthritis - as well as increasing medical costs for the individual and the health system.

Building on the momentum of the First Lady Obama's "Let's Move" initiative and the Secretary's leadership, HHS has marshaled the skills and expertise from across the Department to address this epidemic with research, public education, and public health strategies. Adding to this effort, FDA will issue several rules designed to provide more useful, easy to understand dietary information - tools that will help millions of American families identify healthy choices in the marketplace. ²⁵

- One final rule will require restaurants and similar retail food establishments with 20 or more locations to list calorie content information for standard menu items on restaurant menus and menu boards, including drive-through menu boards.²⁶ Other nutrient information-total calories, fat, saturated fat, cholesterol, sodium, total carbohydrates, sugars, fiber and total protein-would have to be made available in writing upon request.

- A second final rule will require vending machine operators who own or operate 20 or more vending machines to disclose calorie content for some items.²⁷ The Department anticipates that such information will ensure that patrons of chain restaurants and vending machines have nutritional information about the food they are consuming.

- A third proposed rule would revise the nutrition and supplement facts labels on packaged food, which has not been updated since 1993 when mandatory nutrition labeling of food was first required. The aim of the proposed revision is to provide updated and easier to read nutrition information on the label to help consumers maintain healthy dietary practices.²⁸

Another proposed rule will focus on the serving sizes of foods that can reasonably consumed in one serving. This rule would provide consumers with nutrition information based on the amount of food that is typically eaten as a serving, which would assist consumers in maintaining health dietary practices.²⁹

Promoting International Regulatory Cooperation with our Global Partners

The Department is working to implement Executive Order 13609, "Promoting International Regulatory Cooperation," which charges the Federal Government to identify efforts to align U.S. regulations with those of our global partners to address shared regulatory challenges. FDA has already established such relationships through its participation in key international regulatory cooperation fora, including Codex Alimentarius, the U.S. - Mexico High Level Regulatory Cooperation Council, the U.S. - Canada Regulatory Cooperation Councils. In addition, FDA is developing several rulemakings that have a specific international focus.

- In one proposed rule, FDA will use international standards and promotes harmonization by allowing medical devices companies to use certain kinds of international symbols in device labeling.³⁰

- As a result of collaboration under the U.S.-Canada Regulatory Cooperation Council (RCC), FDA will propose a rule to add the common cold indication to certain over-the-counter (OTC) antihistamine active ingredients³¹. The objectives of the RCC monograph alignment working group are to conduct a pilot program to develop aligned monograph elements for a selected over-the-counter (OTC) drug category (e.g. aligned directions, warnings, indications and conditions of use) and subsequently, develop recommendations to determine the feasibility of an ongoing mechanism for alignment in review and adoption of these OTC drug monograph elements.

Retrospective Review of Existing Regulations

Pursuant to section 6 of Executive Order 13563 "Improving Regulation and Regulatory Review" (Jan. 18, 2011), the following Regulatory Identifier Numbers (RINs) have been identified as associated with retrospective review and analysis in the Department's final retrospective review of regulations plan. Some of these entries on this list may be completed actions, which do not appear in The Regulatory Plan. However, more information can be found about these completed rulemakings in past publications of the Unified Agenda on reginfo.gov in the Completed Actions section for that agency. These rulemakings can also be found on regulations.gov. The final agency plan can be found at reginfo.gov.

¹ Part II - Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction (RIN: 0938-AR49) (assumes the proposed rule will publish before the Reg Agenda is posted)

² Medical Device Reporting; Electronic Submission Requirements (RIN: 0910-AF86).

³ Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators (RIN: 0937-AA02).

⁴ Flexibility, Efficiency, and Modernization of Child Support Enforcement Programs (RIN: 0970-AC50)

⁵ From 6/21/12 Press Release: http://www.hhs.gov/news/press/2012pres/06/20120621a.html

⁶ http://www.whitehouse.gov/blog/2012/02/16/last-year-54-million-americans-received-free-preventive-services-thanks-health-care-

⁷ http://www.healthcare.gov/news/factsheets/2011/08/womensprevention08012011a.html

⁸ Exchanges Part II--Standards Related to Essential Health Benefits; Health Insurance Issuer and Exchange Responsibilities with Respect to Actuarial Value, Cost-Sharing Reductions, and Advance Payments of the Premium Tax Credit (RIN: 0938-AR03).

⁹ Notice of Benefit and Payment Parameters (CMS-9964-P).

¹⁰ Insurance Market Rules (RIN: 0938-AR40).

¹¹ Medicaid Eligibility Expansion under the Affordable Care Act of 2010 Part 2-NPRM (0938-AR04).

¹² No RINS yet. Internally identified as CMS-1599-P, CMS-1600-P, and CMS-1601-P.

¹³ Prospective Payment System for Federally Qualified Health Centers (No RIN yet; internally identified as CMS-1443-P).

¹⁴ Unique Device Identifier (RIN: 0910-AG31).

¹⁵ Medical Device Reporting; Electronic Submission Requirements (RIN: 0910-AF86).

¹⁶ Hazard Analysis and Risk-Based Preventive Controls (RIN: 0910-AG36).

¹⁷ Current Good Manufacturing Practice and Hazard Analysis and Risk-Benefit Preventive Controls for Food for Animals (RIN: 0910-AG10).

¹⁸ Produce Safety Regulation (RIN: 0910-AG35).

¹⁹ Foreign Supplier Verification Program (RIN: 0910-AG64).

²⁰ Accreditation of Third Parties to Conduct Food Safety Audits and for Other Related Purposes (RIN: 0910-AG66).

²¹ Child Care and Development Fund Reforms to Support Child Development and Working Families (RIN: 0970-AC53)

²² http://www.cdc.gov/obesity/data/adult.html

²³ http://www.cdc.gov/obesity/childhood/index.html

²⁴ http://www.cdc.gov/obesity/data/childhood.html

²⁵ See http://www.letsmove.gov/eat-healthy

²⁶ Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments (RIN: 0910-AG57).

²⁷ Food Labeling: Nutrition Labeling for Food Sold in Vending Machines (RIN: 0910-AG56).

²⁸ Food Labeling; Revision of the Nutrition and Supplement Facts Labels (RIN: 0910-AF22).

²⁹ Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed In One Eating Occasion; Duel Column Labeling; and Modifying the Reference Amounts Customarily Consumed (RIN: 0910-AF23).

³⁰ Use of Symbols in Labeling (RIN: 0910-AG74).

³¹ Over-the-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) Products (RIN: 0910-AF31).