Statement of Regulatory Priorities for Fiscal Year 2018

The Department of Health and Human Services (HHS) carries out a wide array of activities in order to fulfill its mission of protecting and promoting the health and well-being of the American people. From supporting cutting-edge research and disease surveillance to regulating products and facilities to administering programs that help our citizens most in need of access to health care and social services, HHS's work has a clear impact on the daily life of all Americans.

In order to successfully carry out its mission, HHS is committed to a regulatory agenda that is focused on better meeting the needs of the individuals served by its programs, empowering individuals and communities by reducing the burden of compliance, and maximizing the impact of federal investments. Through its rulemakings in the coming fiscal year, HHS will take concrete steps towards streamlining its regulations and improving the transparency, flexibility, and accountability of its regulatory processes in order to realize a future where science, health care, and human services are fundamentally person-centered.

I. More Effectively Meeting the Needs of Individuals

In order to better serve the American people through its programs, HHS will propose a number of regulatory actions aimed at improving service delivery through meaningful information sharing, supporting consumer autonomy and decision-making, and better aligning programs with the most current science.

Improving Service Delivery through Meaningful and Appropriate Information Sharing

In order to deliver quality health care and human services, stronger and clearer regulatory systems that promote the judicious sharing of personally identifiable information among care teams, individuals, and families are necessary, while protecting the confidentiality and security of that information. The Office of Civil Rights (OCR), the Office of the National Coordinator for Health Information Technology (ONC), and the Substance Abuse and Mental Health Services Administration (SAMHSA) intend to promulgate rules related to the sharing of electronic data and records. In particular, OCR plans to propose a rule clarifying information sharing with family members when patients are incapacitated.

Supporting Consumer Autonomy

Integral to a person-centered approach to health care is the concept of autonomy and personal responsibility: providing consumers with the information they need and choices so they can take responsibility for their health and better direct their own care. In order to provide patients with information that is useful, actionable, and comprehensible, the Food and Drug Administration (FDA) plans to amend its regulations regarding the information patients receive for outpatient-administered prescription drugs. To encourage more consumer-directed care, FDA also plans to propose regulations to facilitate access to more treatments for common conditions by using new approaches, including new technologies, to assist consumers in self-selection and use of products that have previously been available only by prescription.

Aligning Programs with Scientific Advancements

In order to best respond to the needs of patients, it is crucial that HHS regulations and programs reflect current science. HHS is fulfilling this need by updating regulations so that the Department can utilize the full spectrum of current scientific thinking when carrying out program activities. Specifically, the Health Resources and Services Administration (HRSA) plans to revise the Vaccine Injury Table to include vaccines that the Centers for Disease Control and Prevention (CDC) recommends for administration to pregnant women. This revision will allow injuries related to these vaccines to be eligible for the National Vaccine Injury Compensation Program. Additionally, FDA intends to propose a new rule that will modernize mammography quality by recognizing new technologies, making improvements in facility processes, and the reporting of breast density, which is now widely recognized as a risk factor for breast cancer.

II. Empowering Individuals and Communities Through Reducing Regulatory Burden

In order to make HHS programs more person-centered, the rulemakings described above must be accompanied by serious efforts to decrease the burden of complying with Federal regulations. Regulatory burden can result from a variety of sources, including reporting requirements, outdated restrictions, requirements and/or conditions not required by the authorizing statutes, and a lack of clear regulatory guidelines. HHS is committed to streamlining and clarifying its regulations to reduce unnecessary burden while continuing to protect the public health and to meet the human services needs of the American people.

Minimizing Duplication and Burdensome Requirements

The Department recognizes the burden that requirements for many of its programs place on States, territories, tribes, local governments, industry, providers and facilities, caseworkers, grant recipients, and individuals. HHS plans to actively engage stakeholders in transparent, deliberative processes to ensure that the Department strikes an appropriate balance between reducing burden and continuing to administer high-quality programs. For example, The Administration for Children and Families (ACF) plans to issue an Advanced Notice of Proposed Rulemaking seeking public comment on its 2016 Final Rule on the Adoption and Foster Care Analysis and Reporting System (AFCARS), which doubled reporting requirements for States and tribes. Through careful consideration of all comments submitted by the public during this process, ACF believes it can streamline the 2016 Rule so that States and tribes are able to devote less time and fewer resources to administrative work and redirect those efforts to the children they serve.

The Centers for Medicare & Medicaid Services (CMS) plans to propose changes to the current Conditions of Participation (CoPs) or Conditions for Coverage (CfCs) that health care organizations must meet in order to begin and continue participating in the Medicare and Medicaid programs. These changes will simplify and streamline the current regulations by reducing the frequency of certain required activities and, where appropriate, revising timelines for certain requirements for providers and suppliers. These changes will also increase provider flexibility and reduce excessively burdensome regulations, while allowing providers to focus on providing high-quality health care to their patients. Ultimately, these proposals balance patient safety and quality, while also providing broad regulatory relief for providers and suppliers.

Through initiatives to eliminate regulatory burdens that negatively impact the doctor-patient relationship, the Department will take steps to remove duplicative requirements, streamline data collection and reporting requirements, and make meaningful reforms to programs that limit access to care. For example, CMS plans to finalize the physician fee schedule, which will eliminate the redundant reporting of the modifier in the professional claim to reduce burden for eligible practitioners. The Inpatient Prospective Payment System (IPPS), which HHS has finalized for fiscal year 2018, also reduces the electronic quality reporting measures from eight to four measures, to reduce burden for eligible practitioners and ensure they are spending more time caring for the patient rather than in front of a computer screen. HHS intends to continue building on this progress in the next fiscal year rule.

Eliminating Outdated Restrictions and Obsolete Regulations

In addition to minimizing regulatory burden, HHS realizes that many of its regulations may contain provisions that are outdated, obsolete, or otherwise not applicable to the current environment. HHS has resolved to reform its processes so that those providing care and other services to Americans are able to thrive within the State and federal regulatory environment. As an early step in this broader effort, CMS plans to issue a proposed rule that will remove unnecessary and outdated requirements from the conditions of participation for the Medicare and Medicaid programs for Long-Term Care facilities. Currently, these requirements often impede the delivery of quality care and divert resources away from facility residents.

Providing Necessary Regulatory Clarity to Industry Stakeholders

While the above rulemakings seek to correct overregulation, in some cases, HHS programs lack the necessary regulations in order to make their processes transparent and predictable. For example, in the context of FDA's tobacco program, rulemaking is needed to clarify for industry what is required to be included in premarket applications and the procedures that will be followed in submitting and reviewing these submissions as part of a comprehensive framework to regulate nicotine and tobacco and advance the public health. In addition, FDA is updating important rules for medical device applications so the rules reflect risk-based and least burdensome pathways to market for devices, including new and innovative devices. These rules will fill gaps to ensure that manufacturers in these sectors know how to bring innovative products to market that may save lives or reduce health risks. FDA intends to begin rulemaking this fiscal year to fill these regulatory gaps so that these processes become more fair, efficient, and predictable.

In response to extensive outreach to physician stakeholders, HHS anticipates a number of changes associated with private practice physicians and their arrangements with Medicare Advantage Organizations (MAOs). Of the nearly 200 regulatory burdens reported by more than 30 trade associations, 12 percent of the groups requested clarity with regards to the ways MAOs audit physicians and their practices. CMS plans on issuing a Part C and D rule for Contract Year 2019, that responds to these concerns. The rule will also seek comment on ways to improve MAO audits of solo practitioners and their practices.

III. Maximizing the Impact of Every Federal Dollar Spent

In order to truly protect and promote the health and wellbeing of the American people, HHS must ensure that each and every taxpayer dollar it spends is used wisely and managed responsibly. HHS's efforts to reduce burden and move toward more person-centered programs must be coupled with a department-wide determination to do more with the resources that it has. By doing so, HHS hopes to use taxpayer funds responsibly to reach as many Americans in need as possible directly through its programs and to empower its community partners to do the same.

Protecting the Integrity of HHS Programs

A key component of maximizing the impact of HHS's investments - and protecting taxpayer dollars - is program integrity. Without consistent efforts to identify fraud, waste, and abuse and respond accordingly, the Department cannot be certain that its funds are going toward their intended use nor can it maintain the public's confidence in its programs. As such, the Department is committed to keeping program integrity a priority in the coming years. This year, CMS plans to finalize a rule that will implement crucial authorities provided by Congress to deny or revoke a provider or supplier's Medicare enrollment in certain circumstances specified in the rule. Additionally, HRSA plans to publish an NPRM imposing civil monetary penalties on drug manufacturers who knowingly and intentionally charge 340B program participants a price higher than the program ceiling price.

Promoting Flexibility for States, Grantees, and Regulated Entities

Alongside program integrity activities, HHS intends to enhance regulatory flexibility so that its State and community partners are able to better tailor their programs to fit the needs of the people they serve. Particularly in the context of the Secretary's three clinical priorities - combatting the opioid crisis, childhood obesity, and serious mental illness - the Department has begun looking seriously at its programs to see how it can maximize the number of people reached through amending its regulations to remove or change regulatory limitations on grantees and regulated entities. Specifically, SAMHSA plans to publish an NPRM exploring ways that it could better facilitate the ability of individuals with an Opioid Use Disorder to access interim maintenance treatment while they are waiting to begin a comprehensive treatment plan. In addition, ACF plans to consider revising minimum service duration requirements for Head Start center-based programs. Rulemaking carried out in 2016 nearly doubled the current minimum. If revised again, center-based Head Start programs would likely be able to serve more children and choose a duration that better reflects the needs and daily schedules of the families they serve.

As a way of promoting flexibility for States, CMS also plans to propose a rule related to Medicaid and CHIP Managed Care. This rule would streamline the regulatory framework and provide burden reductions to ensure state Medicaid agencies are able to work effectively with CMS to design, develop, and deploy managed care programs that meet the state population's needs. These changes support state flexibility, local leadership, and innovation in the delivery of care.

In the coming fiscal year, HHS plans to consider a number of regulatory and deregulatory actions intended to make its processes more flexible, efficient, and transparent. In order to fully realize the potential of these efforts, HHS recognizes the need for a collaborative rulemaking process where the concerns of stakeholders are appropriately considered. By working with its community partners to understand the challenges that they face under HHS's current regulatory structures and where there are opportunities for improvement, the Department hopes to modernize and streamline its regulations to better serve the needs of the American people.