DEPARTMENT OF HEALTH AND HUMAN SERVICES

Statement of Regulatory Priorities for Fiscal Year 2017

As the Federal agency with principal responsibility for protecting the health of all Americans and for providing essential human services, especially to those least able to help themselves, 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 2017 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 its efficiency and accountability includes its innovation agenda, program integrity and key human resources initiatives. In particular, the Department plans to issue a final regulation revising administrative appeal procedures for Medicare claims 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entities by updating current rules to align them with emerging health and safety standards, and by eliminating outdated procedural provisions.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 http://www.hhs.gov/retrospectivereview.

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.

Preventing and Reducing Tobacco-Related Death and Disease

In 2009, Congress enacted the Family Smoking Prevention and Tobacco Control Act, authorizing the U.S. Food & Drug Administration (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 past year, FDA finalized the regulation deeming other tobacco products that meet the statutory definition of "tobacco product" to also be subject to the Food, Drug and Cosmetic Act (FD&C Act). This final regulation, known as the "deeming rule," affords FDA the authority to regulate additional products which include hookah, electronic cigarettes, cigars, pipe tobacco, other novel tobacco products, and future tobacco products. Over the next year, FDA plans to issue further procedural and substantive augmentation of that landmark regulation, designed to both clarify the regulatory landscape for tobacco products and enhance information available to consumers on the health risks of tobacco use.

Preventing the Spread of Disease Across Borders

Over the next year, the Centers for Disease Control and Prevention (CDC) plans to finalize amendments to the foreign and interstate quarantine regulations to more efficiently and effectively respond to communicable disease threats to the public's health. The regulation adds requirements for the collection of passenger and crew information, allows for the public health screening of travelers, and revises and adds relevant definitions.

Drugs and Medical Devices

FDA plans to issue a proposed rule addressing medication guide regulations to require a new form of patient labeling, Patient Medication Information, for submission to and review by FDA for human prescription drug products used, dispensed, or administered on an outpatient basis. The proposed rule would include requirements for Patient Medication Information development, consumer testing, and distribution. The proposed rule would require clear and concise written prescription drug product information presented in a consistent and easily understood format to help patients use their prescription drug products safely and effectively. FDA is also proposing to amend its regulations governing mammography. The amendments would update the Mammography Quality Standards Act of 1992. FDA is taking this action to address changes in mammography technology and mammography processes that have occurred since the regulations were published in 1997 and to address breast density reporting to patient and health care providers.

Improving Substance Use Treatment and Research Opportunities

The Substance Abuse and Mental Health Services Administration (SAMHSA) is working to finalize changes to 42 CFR 2, the Confidentiality of Substance Use Disorder Patient Records. The part 2 regulation protects the confidentiality of records that are maintained in connection with any federally assisted program or activity related to substance abuse education, prevention, training, treatment, rehabilitation, or research. Under the part 2 statute and current regulations, a federally assisted substance abuse program may only release patient identifying information related to substance abuse treatment services with the individual's written consent; pursuant to a court order; or under a few other limited exceptions. These protections are more stringent than most other privacy laws, including HIPAA. SAMHSA is updating the part 2 rule in order to make it more compatible with new models of integrated care, which are based on information sharing, participation of multiple healthcare providers, and the development of an electronic infrastructure for managing and exchanging patient data. Part 2 has restricted the exchange of some of this data, to the detriment of patient care and research.

III. Reducing the Number of Uninsured and Providing Access to Affordable Quality Care

The Affordable Care Act (ACA) 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 ACA 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

Forthcoming proposed and final rules will bring to completion regulatory provisions that support our efforts to assist states in implementing Medicaid eligibility and enrollment provisions stemming from the Affordable Care Act. These changes provide states more flexibility to coordinate Medicaid and CHIP eligibility notices, appeals, and other related administrative procedures with similar procedures used by the Exchanges.

Updating Organ Donation Authorities

The Health Resources and Services Administration (HRSA) is undertaking a regulation to improve and streamline the process for human organ donation. HRSA is proposing a final rule that clarifies that peripheral blood stem cells are included in the definition of bone marrow under section 30 of the National Organ Transplantation Act of 1984.

IV. Leading in Science and Innovation

HHS continues to expand on early successes of a number of initiatives, including the Precision Medicine Initiative, BRAIN Initiative, and the Vice President's Cancer Moonshot, specifically by updating the rules that govern research with human participants. In particular, HHS plans to finalize revisions to existing rules governing research with 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 final rule will aim to better protect human subjects while facilitating research, and also reducing burden, delay, and ambiguity for investigators.

Patient-Centered Improvements to Health Technology

HHS plans to undertake regulations designed to enhance both security and interoperability of electronic and other health records to improve access to care. These initiatives include an update to the regulations regarding confidentiality of substance abuse treatment records to align with advances in health information technology (health IT) while maintaining appropriate patient privacy protections.

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. In particular, the annual Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and FY 2018 Rates proposed rule revises the Medicare hospital inpatient and long-term care hospital prospective payment systems for operating and capital-related costs. This proposed rule would implement changes arising from our continuing experience with these systems.

Improving the 340B Program

HRSA plans to issue two regulations intended to improve transparency and operation of its 340B Drug Pricing Program. These regulations include: