FY 2024 Annual Performance Plan and Report - Strategic Goal 1: Objective 1.2

Fiscal Year 2024
Released March, 2023

Topics on this page: Objective 1.2: Reduce costs, improve quality of healthcare services, and ensure access to safe medical devices and drugs | Objective 1.2 Table of Related Performance Measures

Objective 1.2: Reduce costs, improve quality of healthcare services, and ensure access to safe medical devices and drugs

HHS supports strategies to reduce costs, improve quality of healthcare services, and ensure access to safe medical devices and drugs for everyone.  HHS develops and implements payment models in partnership with healthcare providers and establishes other incentives to improve quality care while reducing healthcare spending.  HHS implements and assesses approaches to improve healthcare quality, and address disparities in healthcare quality, treatment, and outcomes.  The Department also improves patient safety, strengthens access to safe and effective medical products and devices, and expands approaches to safely exchange information among patients, providers, and payers.

The Office of the Secretary leads this objective.  The following divisions are responsible for implementing programs under this strategic objective: AHRQ, ASPE, CDC, CMS, FDA, HRSA, IHS, NIH, OASH, ONC, and SAMHSA.  In consultation with OMB, HHS has determined that performance toward this objective is progressing.  The narrative below provides a brief summary of progress made and achievements or challenges, as well as plans to improve or maintain performance.

Objective 1.2 Table of Related Performance Measures

The Medicare Prescription Drug Improvement and Modernization Act of 2003 amends Title XVIII of the Social Security Act by adding a Voluntary Prescription Drug Benefit Program (Medicare Part D).  Since its inception, Medicare Part D has significantly increased the number of beneficiaries with comprehensive drug coverage and enhanced access to medicines.

While Medicare Part D offers substantial insurance coverage for prescription drugs, it does not offer complete coverage.  Prior to 2010, a beneficiary was responsible for paying 100 percent of the prescription costs between the initial coverage limit and the out-of-pocket threshold (or catastrophic limit).  Only once the beneficiary reached the catastrophic limit, did Medicare coverage recommence.  This is known as the coverage gap (or “donut hole”).  The Affordable Care Act began closing the coverage gap through a combination of manufacturer discounts and gradually increasing federal subsidies until it closed in 2020.  For CY 2020 and beyond, this means that non-LIS beneficiaries who reach this phase of Medicare Part D coverage will pay no more than 25 percent of costs for all covered Part D drugs. For 2023, beneficiaries reach this phase when total drug costs amount to $4,660 and stay in this phase until they pay $7,400 in qualified out-of-pocket costs. CMS’ tracking of this measure has shown that that in most years non-LIS out-of-pocket costs have decreased beyond the targets required by statute.  

The statute which established the Coverage Gap Discount Program gave CMS the authority to authorize exceptions to the requirement that manufacturers have their applicable drugs be covered under a Coverage Gap Discount Program agreement (Section 1860D-43 (C)) in extenuating circumstances.  However, CMS successfully encourages all manufacturers of applicable drug products to participate in the program, which results in the consistent application of discounts for all branded products.  Furthermore, the infrastructure which has been put in place treats manufacturers fairly, which has resulted in manufacturers choosing to stay in the Part D program.  Specifically, it: 1) allows public access to information about which manufacturers are participating in the program, and 2) offers an equitable process for manufacturers to dispute invoiced amounts. This has occurred without any meaningful decreases in manufacturer participation in the Part D market.  As generic utilization in the Part D program has remained static, and very high (over 75 percent since 2012), that is not a strong contributor to the success of this goal.  Rather, CMS’ application and management of the Coverage Gap Discount Program, coupled with the strong incentives for manufacturers to participate in the Part D program, are the primary drivers of this goal’s success.

HHS and CMS, through the Center for Medicare and Medicaid Innovation (CMMI), identifies, tests, evaluates, and expands, as appropriate, innovative payment and service delivery models.  The Medicare Shared Savings Program Accountable Care Organizations (ACOs) also play an integral role in moving Medicare toward value-based payment models and person-centered care, with over 11 million people with Medicare receiving care from a health care provider in a Shared Savings Program ACOs as of January 1, 2022.  These innovative payment and service delivery models can reduce program expenditures for Medicare, Medicaid, and the Children’s Health Insurance Program, while improving or preserving beneficiary health and quality of care. 

To further accelerate movement away from paying for volume and towards paying for value and outcomes, CMS lauched a bold new strategy with the goal of achieving equitable outcomes through high quality, affordable, person-centered care.  On October 20, 2021, CMS published a white paper detailing CMS’s vision for the next 10 years (Innovation Strategy Refresh).  In November 2022, CMS published a one-year update on progress made achieving this vision, including measures for success against key objectives (Person-Centered Innovation - An Update on the Implementation of the CMS Innovation Center's Strategy).  As part of this strategic refresh, CMS set a new 10-year Medicare goal and target to have all beneficiaries in a care relationship with accountability for quality and total cost of care by 2030 (see newly developed measure CMMI6).

CMS did not meet its FY 2021 target because of the unprecedented impact of the COVID-19 pandemic, more limited opportunities for enrollment in new CMMI models, and a plateauing of participation in the Medicare Shared Savings Program.

The goal of GDUFA III is to build on the successes GDUFA I and II, with a focus on maximizing the efficiency of and utility of each assessment cycle with the intent to reduce the number of assessment cycles for ANDAs and facilitate timely access to quality, affordable, safe, and effective generic medicines.  Certain new enhancements in GDUFA III are specifically designed to foster the development, assessment and approval of ANDAs for complex generic products.  GDUFA III also assures a sound financial foundation to support the vital activities of the Generic Drug Program.  The value of this investment in the Generic Drug Review program is reflected by FDA’s performance on its goals under GDUFA, including the review of standard submissions reflected in this performance measure, as well as FDA’s commitment to meet shorter review goals (8 months) for priority submissions under GDUFA II and GDUFA III.  Despite the unforeseen challenges due to the COVID-19 pandemic, including having to transition to a remote work environment with an increased workload due to the expedited development and review of generic drug submissions for products that could help address the public health emergency, FDA rose to the challenge and maintained its high level of performance in meeting GDUFA’s goals and initiatives.  HHS is confident that the new processes introduced through GDUFA III, and activities taken under FDA’s Drug Competition Action Plan will continue to help reduce assessment cycles, improve approval times, and boost competition, helping to ensure that quality, affordable, safe and effective generic drug products are available to the American public.

A major output of the Patient Safety Portfolio is the availability of evidence-based resources and tools that can be utilized by healthcare organizations to improve the care they deliver, and, specifically, patient safety.  An expanding set of evidence-based tools is available as a result of ongoing investments to generate knowledge through research and synthesize and disseminate this new knowledge in the optimal format to facilitate its application.

The Agency continues provide many and a large variety of resources and tools to improve patient safety.  Examples include:

• AHRQ Patient Safety Network (AHRQ PSNet) & Web M&M (Morbidity and Mortality Rounds);
• AHRQ Question Builder App;
• AHRQ’s Safety Program for Nursing Homes: On-Time Pressure Ulcer Prevention;
• Common Formats (standardized specifications for reporting patient safety events);
• Guide to Improving Patient Safety in Primary Care Settings by Engaging Patients and Families;
• Healthcare Simulation Dictionary, Second Edition;
• Making Healthcare Safer III Report; Primary Care-Based Efforts To Reduce Potentially Preventable Readmissions;
• Reducing Diagnostic Errors in Primary Care Pediatrics (Project RedDE!);
• Re-Engineered Discharge (RED) Toolkit;
• Toolkit To Improve Antibiotic Use in Acute Care Hospitals;
• Understanding Omissions of Care in Nursing Homes.

The Patient Safety Portfolio is projecting that the number of evidence-based resources and tools will continue to increase with a projected cumulative number of 275 in FY 2022 and 300 in FY 2023, and 325 in FY 2024.

HRSA funded health centers improve health outcomes by emphasizing the care management of patients with multiple health care needs and the use of key quality improvement practices, including health information technology.  HRSA’s Health Center Program Patient Centered Medical Home (PCMH) Initiative supports health centers to achieve national PCMH recognition, an advanced model of primary care using a team-based approach to improve quality through coordination of care and patient engagement.  Currently, 77 percent of health centers are recognized by national accrediting organizations as Patient Centered Medical Homes.

PCMH recognition assesses a health center’s approach to patient-centered care and evaluates health centers against national standards for primary care that emphasize care coordination and on-going quality improvement.  PCMH recognition also increases health outcomes, improves health equity, and lowers costs for patients and health centers, and has become a standard of care for HRSA funded health centers.  HRSA set the FY 2024 target based on data trends.

HRSA’s Office for the Advancement of Telehealth has several programs that allow grantees to focus entirely, or in part, on expanding access to telebehavioral services in rural and underserved communities.  This measure reflects programs with different focus areas and cohorts.  As such, measure results will vary from year-to-year due to expected turnover in grantee cohorts and focus areas, and targets will need to be evaluated on an ongoing basis.  In addition, recent data represents results from FY 2021 and was collected between September 2021 through August 2022, aligning with the program period.  The targets for FY 2024 have been established based on the current cohorts for TNGP—the Telehealth Network Grant program for emergency services and the Evidence-Based Telehealth Network program for Direct-to-Consumer services—for which tele-behavioral health is not the primary focus.  Past Telehealth Network Grant programs such as the Evidence-based Tele-behavioral Health Network Program (FY 2018 – FY 2020) did allow for grantees to focus solely on telebehavioral health.

The Title X Family Planning program is the only federal grant program dedicated solely to providing individuals with comprehensive family planning and related preventive health services.  Enacted in 1970 as part of the Public Health Service Act, the Title X program is designed to provide access to contraceptive services, supplies, and information to all who want and need them.  By law, priority is given to persons from low-income families.

The program’s performance measures focus on increasing access to high-quality care and serving individuals and families from underserved, vulnerable and low-income populations, gauging the extent to which Title X expands the availability of quality healthcare to the public.  Performance measurement guides program strategies, establishes directions for technical assistance, and directs revisions to program policies.  This enables Title X to better address program performance and facilitates methods to increase efficiency in the delivery of preventive healthcare services. 
Of particular importance, Title X service grantees provide high-quality contraceptive counseling and care, recommended chlamydia screening, screening for undiagnosed cervical tissue abnormalities, preconception care and counseling, basic infertility services, pregnancy testing and counseling, adolescent services and related education and counseling.  These services, along with community-based education and outreach, assist individuals and families with pregnancy leading to healthy birth outcomes and prevention of unintended pregnancy.  The target and data collection efforts around unduplicated clients served through the Title X program helps track core performance aligned with Title X’s mission.

The marked decrease in Title X performance between 2021 and 2019 is attributable to two main factors: the 2019 Final Rule and the COVID-19 pandemic.  On March 3, 2019, HHS issued a Final Rule that revised Title X regulations governing several aspects of how Title X-funded projects deliver family planning care.  The implementation of the 2019 Title X Final Rule led to 19 grantees (and their networks) immediately withdrawing from the program; 18 other grantees reported losses to their service networks.  These departures significantly reduced the Title X service network.  While supplemental awards were made to compensate for these departures; the program experienced a net decrease of more than 1,000 service sites.  Additionally, the emergence of the novel coronavirus in 2020 created a public health emergency that affected all aspects of healthcare delivery, which varied in both scope and duration, severely disrupting Title X clinical operations.

In October 2021, the Department amended the Title X Family Planning regulations to restore access to equitable, affordable, client-centered, quality family planning services for more Americans.  Aligned with the new program policies, performance targets have been established to restore the breadth of client access that is central to Title X’s mission.

Endnotes

¹³ Baseline data includes school-based TNGP and Substance Abuse Treatment (SAT) TNGP which were discontinued after FY 19.  This data and out year data from the Emergency Department (ED) TNGP and Evidence-based (EB) Evidence-based Tele-behavioral Network Program (TNP) programs will be used to identify trending over a three-year period, as the measure is developmental.  Once HRSA analyzes a trend, appropriate targets will be identified.  HRSA expects that with turnover in cohorts and focus areas, the target will need to be evaluated on an ongoing basis.

¹⁴ This data represents FY 20 reporting involving the ED TNGP and EB TNP programs which will be used to identify trending over a three-year period, as the measure is developmental.  Once HRSA analyzes a trend, appropriate targets will be identified.  HRSA expects that with turnover in cohorts and focus areas, the target will need to be evaluated on an ongoing basis.