As the lead federal agency responsible for protecting the health of all Americans and 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; increase efficiency, transparency, and accountability of HHS programs; and strengthen the nation's health and human services infrastructure.

The Department's regulatory agenda for Fiscal Year 2014 advances this mission by issuing rules that will: increase access to health care for all Americans and strengthen the Medicare program, the nation's largest insurance provider; support the President's commitment to implement strategies to reduce gun violence; build from previous experiences to safeguard the nation's food supply; promote children's health and well-being through programs that target those critical early years; arm 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. This overview highlights several regulations that best exemplify these priorities.

Expanding Coverage in the Private Health Care Market and Strengthening Medicare

The Department continues to implement Affordable Care Act provisions that expand health insurance coverage and promote health care security for all Americans. Millions of Americans - including women, families, seniors, and small business owners - are already benefitting from the Affordable Care Act. As the Department begins open enrollment in the Health Insurance Marketplaces, we will continue to provide guidance to states, providers, and insurers to enhance the experience of individuals and families accessing the Marketplaces. In addition, the Department plans to publish other rules that would enhance the protections of the Affordable Care Act.

- For example, the Centers for Medicare and Medicaid Services (CMS) is preparing to monitor and update policies related to the Health Insurance Marketplaces based on experience with initial open enrollment to address emerging needs of states, health care providers, and insurers.[1]

- CMS, along with the Departments of Labor and the Treasury, recently published a final rule to implement the Mental Health Parity and Addiction Equity Act (MHPAEA) of 2008, which 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 and health insurance coverage offered in connection with a group health plan. The Affordable Care Act builds on MHPAEA and requires coverage of mental health and substance use disorder services as one of ten essential health benefits categories. Under the essential health benefits rule, individual and small group health plans are required to comply with these parity regulations. This rule, in conjunction with the Affordable Care Act provisions will expand mental health and substance use disorder benefits and parity protections for 62 million Americans.[2]

CMS has also identified a number of opportunities to strengthen the Medicare program by updating rules related to health care payments and issuing rules to help root out potential waste, fraud, and abuse.

- In one such rule, CMS will propose certain qualification standards regarding the types of prosthetic and orthotic devices billable to the Medicare program.[3] This rule continues the Department's efforts to identify and eliminate avenues for Medicare fraud and works to protect the Medicare Trust Fund.

- In addition, CMS will update several Medicare provider payment rules to better reflect the state of practice and be responsive to feedback from providers.[4] These rules, which are published annually, provide predictability for health care providers so they can manage their finances appropriately.

Advancing Strategies to Reduce Gun Violence

On April 23, 2013, the Department published an Advance Notice of Proposed Rulemaking (ANPRM) requesting public input on issues related to the HIPAA Privacy Rule and reporting to the National Instant Criminal Background Check System (NICS) the identities of individuals subject to a federal mental health prohibitor that disqualifies the individuals from possessing or receiving a firearm. The ANPRM also announced the Department's consideration of a proposal to modify the HIPAA Privacy Rule to expressly permit certain covered entities to disclose to NICS the identities of individuals subject to the federal mental health prohibitor. This NPRM will address public comments received in response to the ANPRM and includes proposals to help facilitate NICS reporting.

Safeguarding the Nation's Food Supply

FDA will continue its work to implement the Food Safety Modernization Act and other statutory authorities related to food safety, working with public and private partners to build a new system of food safety oversight. In the past year, FDA has issued significant proposed rules on preventive controls for human food and produce safety, as well as foreign supplier verification for importers and accreditation of third-party auditors. This year, FDA will continue its work to enhance its oversight of the nation's food supply, including publishing rules that will help curb the development of antimicrobial resistance in food products. For example:

- FDA recently issued a proposed rule establishing preventive controls in the manufacture and distribution of animal feeds.[5] This regulation, as well as a companion piece related to human foods, 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.

- In another proposed rule, FDA is codifying a provision in the Animal Drug User Fee Amendments of 2008 that requires sponsors of antimicrobial new animal drug products to annually report the amount of antimicrobial active ingredient in those drugs that are sold or distributed for use in food-producing animals, as well as outline other requirements for collecting additional drug distribution data. This rule will help FDA address the problem of antimicrobial resistance and will help ensure that FDA has the necessary information to examine safety concerns related to the use of antibiotics in food-producing animals.[6]

Promoting Children's Health and Well-being

The Administration for Children and Families' (ACF) regulatory portfolio includes rules that promote children's health and well-being by strengthening programs that serve children and their families. Specifically, ACF rules support the President's Early Learning Initiative: a series of new investments that will establish a continuum of high-quality early learning for a child - beginning at birth and continuing to age five.

- For example, one final rule would provide the first comprehensive update of Child Care and Development Fund (CCDF) regulations since 1998.[7] 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. This final 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 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.

- Another final rule would amend Head Start program eligibility standards, as a component of an ongoing effort to strengthen the Head Start program and help ensure for children and families most in need access to this high-quality educational program.[8]

Empowering Americans to Make Healthy Choices in the Marketplace

As of 2010, more than one-third of U.S. adults[9] and 17% of all children and adolescents[10] 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.[11] 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 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.[12]

- 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.[13] 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.[14] 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.[15]

- 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 healthy dietary practices.[16]

Reducing the Harms of Tobacco Use

In 2009, Congress enacted the Family Smoking Prevention and Tobacco Control Act, which authorized FDA to regulate tobacco for the first time in history. Under the Tobacco Control Act, FDA has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and for reducing tobacco use by minors. In the coming year, FDA plans to issue a proposed rule that would clarify which products containing tobacco, in addition to cigarettes, are subject to FDA oversight. [17] This rule would also allow FDA to establish regulatory standards on the sale and distribution of tobacco products, such as age-related access restrictions and rules on advertising and promotion, as appropriate, to protect public health. This rule will help FDA target its efforts to identify and regulate tobacco products that are intended to entice children and youth.

Modernizing Medical Product Safety and Availability

In 2012, Congress gave FDA new authorities under the Food and Drug Administration Safety and Innovation Act to support its core mission of safeguarding the quality of medical products available to the public while ensuring the availability of innovative products to promote the public health. Similar to its work in the food safety, nutrition, and tobacco control spheres, FDA works diligently to implement regulations springing from this new statutory authority with a focus on enhancing FDA oversight and 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, a newly issued regulatory proposal would 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.[18] This rule would help FDA address and potentially prevent drug shortages and would help inform providers and public health officials earlier about potential drug shortages.

- Another recent proposed rule would update FDA's regulations to reflect the increased use of generic drugs in the current marketplace and create parity between brand name and generic drug manufacturers with regards to the ability to update product labeling. In this rule, FDA would propose to allow generic drug manufacturers to independently update product labeling to reflect certain types of newly acquired safety information through submission of a "changes being effected" supplement, irrespective of whether the revised labeling differs from that of the corresponding brand name drug. [19] The rule would also propose the process by which information regarding a "changes being effected" labeling supplement would be made publicly available during FDA's review, so that the public can have timely access to this information.

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 updating rules to align with emerging health and safety standards, eliminating outdated procedures, streamlining rules, and providing flexibility to use technology.

- CMS continues its retrospective review efforts by proposing rules to update safety standards, eliminate redundancies, and reduce burden for patients and providers. For example, one proposed rule would amend the fire safety standards for hospitals, long-term care facilities, intermediate care facilities for the intellectually disabled (ICFs/ID), ambulatory surgery centers (ASCs), hospices which provide in-patient services, religious non-medical health care institutions, and Programs of All-Inclusive Care for the Elderly (PACE) facilities.[20] Further, this proposed rule would adopt the most recent edition of the Life Safety Code (LSC) and eliminate references in our regulations to all earlier editions.

- In another rule, CMS, working with the Centers for Disease Control and Prevention and the Office for Civil Rights, will amend the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to allow laboratories to provide patients with direct access to completed test results at the patient's request. [21] This rule supports the Administration's transparency initiative by allowing consumers to make informed decisions about their care and treatment.

- In a major undertaking, the Department and White House Office of Science and Technology Policy will propose revisions to the ethical rules governing research on human subjects, often referred to as the Common Rule.[22] 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.

[1] Exchange: Eligibility, Enrollment, and Appeals Updates Proposed Rule (RIN: 0938-AS02).


[3] Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS): Special Payment Rules (RIN: 0938-AR84).

[4] Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Fiscal Year 2015 Rates (RIN: 0938-AS11); CY 2015 Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Medicare Part B (0938-AS12); CY 2015 Hospital Outpatient PPS Policy Changes and Payment Rates, and CY 2015 Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (0938-AS15).

[5] Current Good Manufacturing Practice and Hazard Analysis and Risk-Benefit Preventive Controls for Food for Animals Proposed Rule (RIN: 0910-AG10).

[6] Reports of Distribution and Sales Information for Antimicrobial Active Ingredients Used in Food-Producing Animals Proposed Rule (RIN: 0910-AG45).

[7] Child Care and Development Fund Reforms to Support Child Development and Working Families Final Rule (RIN: 0970-AC53).

[8] Head Start Eligibility Determination Final Rule (RIN: 0970-AC46).




[12] See

[13] Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments Final Rule (RIN: 0910-AG57).

[14] Food Labeling: Calorie Labeling of Articles of Food Sold in Vending Machines Final Rule (RIN: 0910-AG56).

[15] Food Labeling; Revision of the Nutrition and Supplement Facts Labels Proposed Rule (RIN: 0910-AF22).

[16] Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Duel Column Labeling; and Modifying the Reference Amounts Customarily Consumed Final Rule (RIN: 0910-AF23).

[17] "Tobacco Products" Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act (RIN: 0910-AG38).

[18] Revision of Postmarketing Reporting Requirements: Permanent Discontinuance or Interruption in Manufacturing of Certain Drug and Biological Products (Drug Shortages) Proposed Rule (RIN: 0910-AG88).

[19] Supplemental Applications Proposing Labeling Changes for Approved Drugs Proposed Rule (RIN: 0910-AG94).

[20] Fire Safety Requirements for Certain Health Care Facilities Proposed Rule (RIN: 0938-AR72).

[21] CLIA Program and HIPAA Privacy Rule: Patients' Access to Test Reports (RIN: 0938-AQ38).

[22] Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators Proposed Rule (RIN: 0937-AA02).