HRSA Takes New Steps to Transform the Organ Transplant System to Better Serve Patients

The Health Resources and Services Administration (HRSA) is taking historic steps as part of its Organ Procurement and Transplantation Network (OPTN) Modernization Initiative, leveraging new legal authority proposed in the President’s Fiscal Year 2024 Budget and signed into law as part of the Securing the U.S. Organ Procurement and Transplantation Network Act in September.

For the first time in four-decades supporting the national organ transplantation system, HRSA is issuing requests for proposals (RFPs) to support multiple different contract awards. This action will increase competition ensuring patients and their families benefit from best-in-class vendors.

HRSA is also taking steps to modernize the critical organ matching technology while increasing transparency and accountability by issuing new data reporting requirements to better address pre-waitlist and organ procurement practices. This important work on “pre-waitlist” practices will help address inequities in the transplant waitlist process by reducing racial and ethnic variation both in patient referrals and in organ procurement.

“For the more than 100,000 patients on the organ waitlist and their families, the time for reform is now,” said HRSA Administrator Carole Johnson. “The steps we at HRSA are taking today demonstrate our commitment to a more fair, well-managed, and high functioning organ transplant system in this country. Patients in need of organ transplant, their families and people who have committed to being organ donors deserve no less.”

Throughout the Biden-Harris Administration, HRSA strengthened the OPTN to better meet the urgent needs of the individuals on the organ transplant waitlist. In March 2023, HRSA launched its visionary OPTN Modernization Initiative to strengthen accountability and the performance of the nation’s organ transplant system by focusing on improving the OPTN’s governance, technology, and operations.

Across the nearly 40-year history of the OPTN, all functions of the OPTN were managed by a single vendor, rather than awarding multiple contracts based on technical expertise in areas like IT or operations. In 2023, new legislation reformed the decades-old statute, enabling HRSA to fundamentally transform the system and make multiple different contract awards to access best-in-class vendors. The legislation also gives HRSA the authority to implement its goal of creating an OPTN Board of Directors independent from other OPTN contractors to strengthen accountability and oversight. In addition, the new law eliminated the arbitrary appropriation cap to fund this work.

As part of HRSA’s OPTN Modernization Initiative, HRSA conducted extensive market research, reviewed responses to a HRSA request for information seeking public input on reforms, hosted two industry days with over 300 participants each, and engaged in more than 800 conversations with patients and community members. For the first time in the history of the program, today HRSA is issuing a solicitation to support an independent OPTN Board of Directors and releasing multi-vendor solicitations for the OPTN informed by this market research and centered on improving outcomes for patients.

HRSA actions include:

  • Releasing a contract solicitation to break up the OPTN monopoly and create an independent OPTN Board of Directors, including supporting a special election to seat a new Board of Directors within six months of contract award. For nearly 40 years, the vendor that received the only OPTN contract and the OPTN itself had the same exact Board of Directors. To improve OPTN fairness, provide independent governance, and ensure strong conflict of interest requirements for the Board, HRSA is separating the Board of Directors, implementing robust new requirements to ensure the independence of the new Board, and issuing a solicitation for a non-profit entity with expertise in governance and process improvement to support the independent OPTN Board. This will include:
    • Establishing a transitional nominating committee and seeking public input to develop a slate of candidates for a Board of Directors special election.
    • Conducting a special election to establish a new, independent OPTN Board of Directors.
    • Reviewing and providing recommendations for modernizing OPTN by-laws and conflict of interest policy and supporting Board implementation.
    • Reviewing Board composition and structure, making recommendations and supporting implementation of approved reforms to improve functionality and system outcomes.
    • Supporting the new Board of Directors in executing its oversight and management responsibilities.
  • Issuing a multi-vendor contract solicitation to support broad competition and best-in-class vendors for critical OPTN functions. This will include:
    • Reviewing and mapping legacy OPTN operations approaches and identifying actionable reforms to improve patient outcomes, system functionality, and system accountability through open competition and heightened HRSA oversight.
    • Developing and implementing processes and metrics for monitoring and measuring patient safety, OPTN member performance, and compliance across all OPTN membership types and phases of the organ donation, procurement, waitlist, matching, transportation, and transplantation processes with a focus on improving patient, donor, and donor family experience.
    • Supporting HRSA Modernization Initiative contractors in the development phase of new modular IT functionalities and the transition to a modernized OPTN IT system that leverages industry-leading standards.
    • Updating and improving IT infrastructure now as a new modernized OPTN IT platform is built and deployed.
    • Providing strategic and administrative services – including improving transparency and increasing public input – to support key OPTN operations functions.
    • Analyzing and implementing approved recommendations to improve transplant program waitlist processes and acceptance criteria.
  • Launching the discovery and development phase of the transition to a modernized OPTN IT matching system that leverages industry-leading IT standards and practices. The discovery process will help build the foundation for the comprehensive organ matching IT system redesign in the Next Gen contract solicitation, which will be released this summer.
  • Taking action to address “pre-waitlist” inequities in the organ waitlist process and reduce variations in referrals to transplant and in organ procurement practices. HRSA is directing the current OPTN vendor to standardize and update data reporting on referral to transplant center, time-to-patient assessment, time-to-organ procurement, and other data to allow for greater accountability in organ procurement and transplant practices across geography and populations and facilitate improved system performance.

The scope and scale of HRSA’s awards under these new solicitations is contingent on final Fiscal Year 2024 appropriations. HRSA’s Fiscal Year 2024 Budget proposes a $36 million increase over Fiscal Year 2023 to support these modernization efforts.

View the full contract solicitations at https://sam.gov.

HRSA Seeking Participants: Cervical Cancer Learning Series for Safety-Net Settings

HRSA’s Office of Women’s Health invites you to participate in CERV-Net: A Cervical Cancer ECHO Learning Series for Safety-Net Settings. CERV-Net is a free, virtual, collaborative learning series that prepares and empowers safety-net providers to engage partners, patients, and communities to ultimately improve cervical cancer care across the cancer continuum.  The series consists of 11 sessions on Thursdays from 9:00-10:00 a.m. (ET) covering cervical cancer prevention, screening, management, and quality improvement activities.  Continuing medical education credits are available at no cost to physicians, nurse practitioners, nurses, and physician assistants.  If interested, please complete the interest form by Tuesday, February 13, 2024. For more details, please contact CERVNet@norc.org.  The Centers for Disease Control and Prevention cite lack of access to screening as a reason for higher prevalence of cervical cancer in rural areas.  Download resources from OWH’s page for the Federal Cervical Cancer Care Collaborative.

Read the full article here.

Rural Provider Participation in Medicare ACOs Grows

In 2024, two Medicare ACO initiatives will have increased participation by rural providers: the Shared Savings Program (SSP), the permanent ACO program, and the ACO REACH Model, which intends to improve access to and care for underserved populations, including those in rural areas. Accountable care organizations (ACOs) are groups of doctors, hospitals, and other health care professionals that work together to give patients high-quality, coordinated service and health care, improve health outcomes, and manage costs. This year, both SSP and ACO REACH will have over 25 percent more participation from Federally Qualified Health Centers, Rural Health Clinics, and Critical Access Hospitals than in 2023.  The increase in SSP is due, in part, to recent changes in the program intended to encourage participation among providers from rural and underserved areas.  Even though the transition from volume-based payment (i.e., fee-for-service with no connection to value) to value-based payment has been slower in rural America than in urban areas, increased rural provider participation in these initiatives furthers the CMS goal for all beneficiaries with traditional Medicare to be in a care relationship with accountability for quality and total cost of care by 2030.

Read the full article here.

CMS Seeking Public Input on Updates to Medicare Advantage and Part D Prescription Drug Coverage – Comment by March 1

The Centers for Medicare & Medicaid Services (CMS) is required to update Medicare Advantage (MA) payment rates and other policies for calendar year 2025.  The full Advance Notice may be viewed on the CMS website by selecting “2025 Advance Notice.”  For Medicare Advantage, CMS proposes to continue phasing in previously finalized adjustments to plan pay rates as well as make new adjustments for MA plans in Puerto Rico.  They also request input on future quality measures.  For the Part D Prescription Drug program, CMS invites comment on draft guidance implementing parts of the Inflation Reduction Act of 2022 (IRA) that take effect in 2025.  Specifically, the IRA creates a newly defined standard Part D benefit design; lowers the annual out-of-pocket threshold; establishes the Manufacturer Discount Program, under which manufacturers provide discounts on applicable drugs in the initial coverage phase and catastrophic phase of the defined standard drug benefit; and changes the liability of enrollees, sponsors, manufacturers, and CMS.  In recent years, non-metro areas have seen slightly higher growth in the number of MA plans and enrollment than metropolitan counties.

Read the full article here.

CMS Hosting Webinar on AHEAD Model Hospital Global Budgets – February 14 at 3:00 pm Eastern

In this hour-long webinar, the Centers for Medicare & Medicaid Services (CMS) will provide an overview of the hospital global budget methodology for the new States Advancing All-Payer Health Equity and Development (AHEAD) Model and answer audience questions. AHEAD is a state total-cost-of-care model, and global budgets are a key feature to control the growth of health care costs and improve care. A hospital global budget pays a pre-determined, fixed annual budget for hospital inpatient and outpatient facility services, rather than paying a fee for each service provided.  This webinar will describe the method CMS will use to calculate the Medicare hospital payment amount for the AHEAD model as well as operational considerations for hospitals.  States interested in participating in the model should submit their applications by Monday, March 18, 2024, at 3:00 p.m. ET (for Cohorts 1 and 2) & Monday, August 12, 2024, at 3:00 p.m. ET (Cohort 3). To get notified about model events and resources, sign up for email updates about the AHEAD Model on the CMS website.

Register here.

NIH Study Shows Higher Mortality Rates for Patients on Respiratory Support in Rural Care

The National Institutes of Health (NIH) published a study finding rural patients receiving ventilator life support in intermediate care units had significantly higher death rates than patients in the same type of unit at urban hospitals.  Data was collected from 2010 to 2019 on 2.75 million hospitalizations of Medicare patients who were on respiratory support at rural and urban hospitals across the country.

Read the full report here.

New Medicaid Model for Treatment of Rare Diseases Introduced

The Centers for Medicare & Medicaid Services (CMS) announced the Cell and Gene Therapy (CGT) Access Model, an initiative that aims to improve the lives of people with Medicaid living with rare and severe diseases by increasing access to potentially transformative treatments. Initially the model will focus on increasing access to gene therapy treatment for sickle cell disease, a genetic blood disorder that disproportionately impacts Black Americans. CGT is a multi-year payment model with state Medicaid agencies and pharmaceutical companies acting as participants, with optional grant funding available for states to provide an increased level of support for patients receiving gene therapy. CMS expects to release a Request for Application (RFA) to manufacturers in early spring 2024 and an RFA and Notice of Funding Opportunity (NOFO) to states in summer 2024.

Read the full article here.

AHRQ Requesting Public Input: Severe Maternal Morbidity Measurement – Comment by March 4

The Agency for Healthcare Research and Quality (AHRQ) needs assistance with data on state-level rates of severe maternal morbidity, that help inform HRSA’s Maternal and Child Health Bureau Title V Block Grant.  Among the questions AHRQ has for stakeholders representing consumers – including but not limited to state and local health departments, accountable care organizations, and providers such as Critical Access Hospitals and Rural Health Clinics – is what quantitative data would you need to make maternal health service improvements.  The comment period closes on March 4th and comments should be sent to askahrq@ahrq.hhs.gov.  Recently, the Government Accountability Office cited several factors that pose additional risks and challenges for pregnant women in rural areas.

Read the full report here.