Statement of Regulatory Priorities for Fiscal Year 2016

As the federal agency with principal responsibility for protecting the health of all Americans and for providing essential human services, especially to those most vulnerable, the Department of Health and Human Services (HHS) implements programs that strengthen the health care system; advance scientific knowledge and innovation; and improve the health, safety, and well-being of the American people.

The Department's regulatory priorities for Fiscal Year 2016 reflect this complex mission through planned rulemakings structured to implement the Department's six arcs for implementation of its strategic plan: Leaving the Department Stronger; Keeping People Healthy and Safe; Reducing the Number of Uninsured and Providing Access to Affordable Quality Care; Leading in Science and Innovation; Delivering High Quality Care and Spending Our Health Care Dollars More Wisely; and, Ensuring the Building Blocks for Success at Every Stage of Life. This overview highlights forthcoming rulemakings exemplifying these priorities.

I. Leaving the Department Stronger

The Department's work to improve the efficiency and accountability includes its innovation agenda, program integrity and key human resources initiatives. In particular, the Department plans to issue a regulation revising administrative appeal procedures for Medicare claim appeals to increase efficiency in the Medicare claims review and appeals process. Additionally, 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entities by updating current rules to align them with emerging health and safety standards, and by eliminating outdated procedural provisions. A full listing of HHS's retrospective review initiatives can be found at

II. Keeping People Healthy and Safe

This HHS strategic priority encompasses the Department's work to enhance health, wellness and prevention; detect and respond to a potential disease outbreak or public health emergency; and prevent the spread of disease across borders. 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. Other representative regulations include:

Labeling and Nutrition Information

The Food and Drug Administration (FDA) plans to issue two 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, include:

- Food Labeling - Nutrition Information: FDA plans a rule, which, if finalized, revises 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

- Food Labeling - Serving Sizes: FDA plans a rule, which, if finalized, requires 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.

Food Safety

FDA will maintain HHS'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. Recently, FDA finalized its preventive controls in the manufacture and distribution of human foods and of animal feeds. This additional suite of regulations, if finalized, constitutes 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, including, Sanitary Transportation of Human and Animal Food and Focused Mitigation Strategies to Protect Food Against Intentional Adulteration.

Preventing Death and Disease from 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. Over the next fiscal year, FDA's planned tobacco regulations include proposing requirements that govern the methods used in the pre-production design manufacture, packing, and storage of tobacco products, a proposed rule that would establish a process for the submission of applications for new tobacco products, and finalizing the regulation deeming other tobacco products that meet the statutory definition of "tobacco product" to also be subject to the FD&C Act. This final regulation, known as the "deeming rule," is necessary to afford FDA the authority to regulate additional products which include hookah, electronic cigarettes, cigars, pipe tobacco, other novel tobacco products, and future tobacco products.

Addressing Substance Use Disorders and Opioid Misuse, Abuse, and Overdose Death Prevention

HHS plans to undertake a number of regulations designed to fight misuse and abuse of prescription opioids and heroin and encourage individuals to seek needed treatment for substance use disorders. These initiatives include an update to the regulations regarding confidentiality of substance abuse treatment records to align with advances in health information technology while maintaining appropriate patient privacy protections. HHS also will undertake an update of the current regulation around prescribing for buprenorphine to increase access to this Food and Drug Administration-approved, evidence-based treatment for opioid dependence and help more people get the treatment necessary for their recovery.

Drugs and Medical Devices

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. HHS is updating 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, if finalized, 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.

III. Reducing the Number of Uninsured and Providing Access to Affordable Quality 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. In implementing the Affordable Care Act over the next fiscal year, HHS will pursue regulations transforming the way our nation delivers care. This includes creating better ways to pay providers, incentivize quality of care and distribute information to build a health care system that is better, smarter and healthier with an engaged, educated, and empowered consumer at the center.

Streamlining Medicaid Eligibility Determinations

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.

Parity for Mental Health Treatment

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. Finalization of this rule will implement MHPAEA by proposing standards for Medicaid alternative benefit plans, Medicaid managed care organizations, and the Children's Health Insurance Program.

Equitable and Non-Discriminatory Treatment

Finalization of the rule implementing the Affordable Care Act's Section 1557 nondiscrimination provisions will ensure access to affordable, quality health care for all Americans - regardless of race, color, national origin, sex, age and ability.

IV. Leading in Science and Innovation

HHS continues to expand on early successes of more precise approaches in a few areas of medicine with the Precision Medicine Initiative (PMI), and work on 21st Century Cures. In particular, HHS, in collaboration with the President's Office of Science and Technology Policy will finalize 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 codified in the final rule will aim to better protect human subjects while facilitating research, and also reducing burden, delay, and ambiguity for investigators.

V. Delivering High Quality Care and Spending Our Health Care Dollars More Wisely

HHS continues work to build a health care delivery system that results in better care, smarter spending, and healthier people by finding better ways to pay providers, deliver care, and distribute information all while keeping the individual patient at the center. In the coming fiscal year, the department will complete a number of regulations to accomplish this strategic objective:

Medicare Payment Rules

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.

Medicaid Managed Care

This final rule modernizes the Medicaid managed care regulations to reflect changes in the usage of managed care delivery systems. The rule aligns the rules governing Medicaid managed care with those of other major sources of coverage, including coverage through Qualified Health Plans and Medicare Advantage plans, implements statutory provision; strengthens actuarial soundness payment provisions to promote the accountability of Medicaid managed care program rates; ensures appropriate beneficiary protections and enhances expectations for program integrity. The rule also implements provisions of the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA) and addresses third party liability for trauma codes.

Improvements to Long-Term Care

This final rule would revise the requirements that long-term care facilities must meet to participate in the Medicare and Medicaid programs. The changes are necessary to reflect advances in the theory and practice of service delivery and safety for patients in long-term care settings. The rule is 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.

VI. Ensuring the Building Blocks for Success at Every Stage of Life

Over the coming year, the Department will continue its support at critical stages of people's lives, from infancy to old age, and topics including early learning, Alzheimer's and dementia. A forthcoming 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 rule, when finalized, 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 rule would also streamline existing regulations to eliminate unnecessary or duplicative requirements.

Both rules are part of the Department's retrospective review initiative and highlight HHS's commitment to protecting the public health and effective human services while pursuing smarter, more efficient regulation over the next fiscal year.