DEPARTMENT OF HEALTH AND HUMAN SERVICES

Statement of Regulatory Priorities for Fiscal Year 2015

As the Federal agency with lead responsibility for protecting the health of all Americans and for providing supportive services for vulnerable populations, the Department of Health and Human Services (HHS) implements programs that strengthen the health care system; advance scientific knowledge and innovation; improve the health, safety, and well-being of the American people; and strengthen the Nation's health and human services infrastructure.

The Department's regulatory priorities for Fiscal Year 2015 reflect this complex mission through planned rulemakings structured to: further increase access to health care for all Americans, especially by strengthening the Medicare, Medicaid and Children's Health Insurance programs; build from previous experiences to safeguard the Nation's food supply; provide consumers with information to help them make healthy choices; and marshal the best research and technology available to streamline and modernize the health care delivery and medical-product availability systems. The following overview highlights forthcoming rulemakings exemplifying these priorities.

Encouraging Delivery System Reforms to Ensure Consumer Access to High Quality, Affordable Care

The Affordable Care Act expands access to health insurance through improvements in Medicaid, the establishment of Affordable Insurance Exchanges, and coordination between Medicaid, the Children's Health Insurance Program, and the Exchanges. A forthcoming final rule will bring to completion regulatory provisions that support our efforts to assist States in implementing Medicaid eligibility determinations, appeals, enrollment changes, and other State health subsidy programs stemming from the Affordable Care Act. The intent of the rule is to afford each State substantial discretion in the design and operation of that State's exchange, with standardization provided only where directed by the Act or where there are compelling practical, efficiency or consumer-protection reasons.

A forthcoming proposed rule would establish policies related to "Stage 3" of the Medicare/ Medicaid Electronic Health Record (EHR) Incentive Programs. The rule is necessary to further implement provisions of the American Recovery and Reinvestment Act that provide incentive payments to eligible providers, hospitals, and critical access hospitals participating in Medicare and Medicaid programs that adopt certified EHR technology. The proposal will offer for comment specific criteria that these providers and facilities would need to meet in order to successfully demonstrate "meaningful use," focusing on advanced use of EHR technology to promote improved outcomes for patients.

The Mental Health Parity and Addiction Equity Act (MHPAEA) requires parity between mental health or substance use disorder benefits and medical/surgical benefits, with respect to financial requirements and treatment limitations under group health plans. A new proposed rule would build on the 2013 final rule implementing MHPAEA by proposing standards for Medicaid alternative benefit plans, Medicaid managed care organizations, and the Children's Health Insurance Program.

Another proposed rule would revise the requirements that long-term care facilities must meet to participate in the Medicare and Medicaid programs. The proposed changes are necessary to reflect advances in the theory and practice of service delivery and safety for patients in long-term care settings. The proposals are also an integral part of our efforts to achieve broad-based improvements both in the quality of health care furnished through Federal programs, and in patient safety, while at the same time reducing procedural burdens on providers.

In addition, nine Medicare payment rules will be updated to better reflect the current state of medical practice and to respond to feedback from providers seeking financial predictability and flexibility to better serve patients.

Streamlining Regulations through Retrospective Review

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 entities by updating current rules to align them with emerging health and safety standards, and by eliminating outdated procedural provisions.

For example, CMS will continue its retrospective review efforts by finalizing an April 2014, proposal to amend the fire safety standards for hospitals, long-term care facilities, ambulatory surgery centers, and a variety of other inpatient care settings. Further, this rule will adopt the most recent edition of the Life Safety Code (LSC) and eliminate references in our regulations to all earlier editions, which will give clear guidance to providers and institutions for these important safety standards.

Similarly, a forthcoming final rule from the Administration for Children and Families (ACF) will provide the first comprehensive update of Child Care and Development Fund (CCDF) regulations since 1998. 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 child care for all families, including those who receive no direct assistance through CCDF.

Another ACF effort would modify existing Head Start performance standards to take into account increased knowledge in the early childhood field since the standards were last updated more than 15 years ago. Changes would strengthen requirements on curriculum and assessment, supervision, health and safety, and governance. The notice of proposed rulemaking would also streamline existing regulations to eliminate unnecessary or duplicative requirements.

Additionally, the Department, in collaboration with the President's Office of Science and Technology Policy will propose revisions to existing rules governing research on human subjects, often referred to as the Common Rule. This rule would apply to institutions and researchers supported by HHS as well as researchers throughout much of the Federal Government who are conducting research involving human subjects. The proposed revisions will aim to better protect human subjects while facilitating research, and also reducing burden, delay, and ambiguity for investigators.

Helping Consumers Identify Healthy Choices in the Marketplace

Since 1980, the prevalence of obesity among children and adolescents has almost tripled. 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's "Let's Move" initiative, HHS has mobilized skills and expertise from across the Department to address this epidemic with research, public education, and public health strategies.

Adding to this effort, the Food and Drug Administration (FDA) plans to issue four final 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. These rules, each benefiting from input received in extended public comment periods, 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 drive-through menu boards. 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;

  • Require vending machine operators who own or operate 20 or more vending machines to disclose calorie content for some items. The Department anticipates that such information will ensure that patrons of chain restaurants and vending machines have access to essential nutrition information ;

  • 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; and

  • Update the serving-size information provided within the food label, providing current nutrition information based on the amount of food that is typically eaten as a serving, to assist consumers in maintaining healthy dietary practices.

    Implementing the Food Safety Modernization Act

    FDA will maintain the agency's ongoing effort to promulgate rules required under the Food Safety Modernization Act (FSMA), working with public and private partners to build a new system of food safety oversight. Responding to extensive feedback from stakeholders, the agency recently issued for further public comment supplemental proposals structured to:

  • Establish preventive controls in the manufacture and distribution of human foods and of animal feeds. These regulations constitute the heart of the FSMA 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.

  • Ensure that produce sold in the United States meets rigorous safety standards. The regulation would 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 adverse health consequences.

  • Require food importers to establish a verification program to improve the safety of food imported into the United States. Specifically, 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.

    Reducing Tobacco Use

    In 2009, Congress enacted the Family Smoking Prevention and Tobacco Control Act, authorizing FDA to regulate the manufacture, marketing, and distribution of tobacco products, to protect the public health and to reduce tobacco use by minors. In the coming fiscal year, benefiting from public scrutiny of an April 2014, regulatory proposal, FDA plans to issue a final rule that will clarify which products containing tobacco, in addition to cigarettes, are subject to the Agency's oversight. This rule would also allow FDA to establish regulatory standards on the sale and distribution of tobacco products, such as age-related access restrictions on advertising and promotion, as appropriate, to protect public health.

    Modernizing Medical-Product Safety and Availability

    In 2012, Congress provided new authorities under the Food and Drug Administration Safety and Innovation Act to support its mission of safeguarding the quality of medical products available to the public while ensuring the availability of innovative products. FDA is implementing this new authority with a focus on protecting the quality of medical products in the global drug supply chain; improving the availability of needed drugs and devices; and promoting better-informed decisions by health professionals and patients.

    For example, the Agency plans to issue a final rule this year to require manufacturers of certain drugs, such as drugs used for cancer treatments, anesthesia drugs, and other drugs that are critical to the treatment of serious diseases and life-threatening conditions, to report discontinuances or interruptions in the manufacturing of these products. This rule will help FDA address and potentially prevent drug shortages, and it will help inform providers and public health officials earlier about potential drug shortages.

    Another forthcoming final rule will update FDA's regulations to reflect the increased use of generic drugs in the current marketplace, and will describe approaches for brand name and generic drug manufacturers to update product labeling. This rule will revise and clarify procedures for updates to product labeling to reflect certain types of newly acquired safety information through submission of a ''changes being effected'' supplement.

    Reducing Gun Violence

    As part of the President's continuing efforts to reduce gun violence, HHS will issue a final rule to remove unnecessary legal barriers under the HIPAA Privacy Rule that may prevent States from reporting certain information to the National Instant Criminal Background Check System (NICS). The NICS helps to ensure that guns are not sold to those prohibited by law from having them, including felons, those convicted of domestic violence, and individuals involuntarily committed to a mental institution. However, the background check system is only as effective as the information that is available to it. The rule will give States and certain covered entities added flexibility to ensure accurate but limited information is reported to the NICS, which would not include clinical, diagnostic, or other mental health information. Instead, certain covered entities would be permitted to disclose the minimum necessary identifying information about individuals who have been involuntarily committed to a mental institution or otherwise have been determined by a lawful authority to be a danger to themselves or others.