FY 2023 Annual Performance Plan and Report - Strategic Goal 1: Objective 1.2

Fiscal Year 2023
Released March, 2022

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.  The narrative below provides a brief summary of any past work towards these objectives and strategies planned to improve or maintain performance on these objectives.

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, beneficiaries pay a deductible and cost-sharing amounts that vary depending on the benefit coverage phase.  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 phase through a combination of manufacturer discounts and gradually increasing federal subsidies until it closed in 2020. The discount applies at the point of sale, and both the beneficiary cost sharing and the manufacturer discounts count toward the annual out-of-pocket threshold (known as True Out-of-Pocket Costs).  This performance measure reflects CMS's effort to reduce the average out-of-pocket costs paid by non-Low Income Subsidy Medicare beneficiaries while in the coverage gap, reached once the combined amount a beneficiary and their drug plan pay for prescription drugs reaches a certain level.  Starting in 2020, non-LIS beneficiaries, who reach this phase of Medicare Part D coverage pay no more than 25 percent of costs for all covered Part D drugs.  CMS's 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 (2019 exceeded the target goal).

CMS identifies, tests, evaluates, and expands, as appropriate, innovative payment and service delivery models that can reduce Medicare, Medicaid, and the Children's Health Insurance Program expenditures while improving or preserving beneficiary health and quality of care.  Under this authority, CMS is testing a variety of alternative payment models (APMs) that create new incentives for clinicians to deliver better care at a lower cost and reward quality and efficiency of care.

Medicare is leading the way by publicly announcing, tracking, and reporting payments tied to APMs that are taking on a downside risk, while working through the Health Care Payment Learning and Action Network (HCP-LAN or LAN) to ensure that its large group of payers, providers, purchasers, patients, product manufacturers, and policymakers across the United States also adopt aligned goals to move towards downside risk APMs.

The final CY 2019 baseline for this new downside risk APM goal is 20.21 percent.  The FY 2020 target was not met due to 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.  On October 20, 2021, CMS published a white paper detailing CMS's vision for the next 10 years (Innovation Strategy Refresh).  As part of this strategic refresh, CMMI is reevaluating the methodology for this measure and future targets to ensure alignment with the 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.

The goal of Generic Drug User Fee Amendments (GDUFA) II is to enhance the efficiency of the generic drug review process, promote transparency between FDA and generic drug sponsors, and enhance access to high-quality, lower cost generic drugs.  Through the reauthorization of the GDUFA program in 2017 (GDUFA II), FDA acquired additional performance goals and higher expectations for program enhancements and approvals.  The value of this investment in the Generic Drug Review program is reflected by FDA's performance on its review goals under GDUFA and FDA's commitment to meet shorter review goals (8 months) for priority submissions under GDUFA II.  Despite the unforeseen challenges due to the COVID-19 pandemic, having to transition to a remote work environment with an increased workload due to the expedited development and review of generic drug products to 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 II and activities taken under FDA's Drug Competition Action Plan will continue to help reduce review cycles, to improve approval times, and to boost competition, helping to ensure that safe, effective, high-quality 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.

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.  Seventy-seven percent of health centers are currently 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 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.  This target was set based on recent data and trends, and on budget projections of no increased targeted funding to support additional PCMH expansion.

HRSA’s Office for the Advancement of Telehealth (OAT) has several programs that allow grantees to focus entirely, or in part, on expanding access to telebehavioral services in rural and underserved communities.  This is a developmental measure that reflects programs with different focus areas and cohorts.  For example, for FY 2019, these results include the School-based Telehealth Network Grant Program and Substance Abuse Treatment Telehealth Network Grant Program, which were discontinued after FY 2019.  For FY 2020, these results include the Emergency Medical Services Telehealth Network Grant Program and the Evidence-based Tele-behavioral Network Program.  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.  OAT plans to identify result trends to establish future targets in FY 2023 based on a three-year average.

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 2020 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.

14. "Result" date and "Target" have been updated to reflect (TBD) due to the unknown impacts of the Coronavirus (COVID-19) pandemic.  CMS cannot fully commit to specific future result dates at this time.
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15. Due to a strategic refresh, CMS will reevaluate future targets for this goal during the fall of 2021.
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