Weekly Roundup -
April 1, 2026
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HMA Acquires HealthTech Solutions, Expanding Technology Capabilities and Medicaid Expertise
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Outlook 2026: Regulatory Uncertainty, Evidence Evolution, and the Future of Healthcare Innovation
As healthcare innovation accelerates, regulatory and policy frameworks are evolving just as rapidly. Across drug development, medical devices, diagnostics, and emerging therapies, innovators are navigating a landscape shaped by shifting federal signals, changing evidentiary expectations, and growing pressure to align regulatory success with real‑world access and affordability.
This article draws on insights from experts at Health Management Associates, Inc. (HMA), and Leavitt Partners, an HMA company, who bring decades of experience working within the US Food and Drug Administration (FDA) and in collaboration with industry leaders to address complex regulatory, commercialization, and access challenges. Their perspectives reflect firsthand experience with translating policy intent into operational reality across the healthcare ecosystem.
These insights underscore a central theme in early 2026: Innovation is advancing faster than the policy frameworks designed to support it. For developers, investors, payers, and policymakers alike, the challenge is no longer whether innovation is possible, but whether regulatory and coverage pathways can evolve quickly and coherently enough to support it.
A More Fragmented Policy Signal Environment
Historically, federal health policy followed relatively formal and predictable channels—rulemaking, guidance documents, and established notice and comment processes. Today, innovators increasingly receive policy signals through nontraditional and informal mechanisms, including agency websites, journal articles, speeches, podcasts, and pilot initiatives.
This evolution in communication and how we ingest information has two implications.
First, it creates greater uncertainty for market planning, as policy direction often emerges incrementally or indirectly. In addition, the higher stakes are higher for understanding the federal regulatory environment. Organizations that closely track agency behavior, precedent, and internal norms are better positioned to distinguish meaningful change from repackaged status quo.
For innovators operating on 10‑to-15-year development timelines, even modest policy volatility can materially affect research and development (R&D) investment decisions, pipeline prioritization, and commercialization strategies.
Innovation Is Outpacing Traditional Evidence Models
Scientific progress, especially in rare disease therapies, advanced biologics, and precision medicine, can both strain and challenge traditional clinical trial paradigms. Small patient populations, heterogeneous disease pathways, and novel mechanisms of action are making large, randomized trials increasingly difficult or impractical.
In response, federal regulators are signaling a broader openness to:
- Real‑world evidence (RWE)
- Natural history studies
- Registries and longitudinal data
- Biomarkers and intermediate endpoints
These approaches are not new, but their expanding role reflects a recognition that traditional evidence hierarchies alone are no longer sufficient for evaluating next‑generation therapies. At the same time, regulators continue to emphasize that alternative evidence must meet rigorous scientific standards, particularly when used to support initial approval or expanded indications.
The implication for innovators is that evidence strategy can no longer be an afterthought. Developers must design programs that support regulatory approval and downstream coverage, pricing, and post‑market evaluation. It is possible for evidence frameworks to overlap, but they must remain distinct.
Regulatory Approval Is a Midpoint for the Innovator Product Journey
A recurring challenge across healthcare sectors is the disconnect between regulatory approval and payer coverage decisions. While regulators focus on safety and efficacy, payers assess value, durability of response, and budget impact because they often struggle to justify large upfront payments within their annual budgeting structure.
This misalignment is particularly acute for high-cost therapies with long-term benefits and products approved through accelerated or flexible pathways, where long-term value may misalign with short-term payer budgeting cycles.
As policymakers explore ways to modernize regulatory frameworks, questions remain about whether coverage and payment systems will adapt in parallel. Without greater alignment, innovators may continue to face scenarios where regulatory success does not translate into timely or consistent patient access.
Predictability and Durability Are Emerging Policy Priorities
Looking further ahead in 2026 and beyond, predictability and durability—not just flexibility—are emerging as core priorities for industry and policymakers alike. Flexibility is essential to support innovation, but durable policy frameworks, particularly those derived from statute, offer greater confidence in long‑term investments.
Several themes will likely shape the next phase for how federal health policy handles innovation:
- Streamlining early clinical development, including first‑in‑human studies
- Codifying successful regulatory pathways to ensure durability across presidential administrations
- Clarifying expectations for post‑market evidence generation
- Improving transparency and consistency in agency advice
These efforts reflect a broader recognition that innovation ecosystems depend not just on scientific breakthroughs, but also on stable rules of the road.
Why It Matters
For healthcare innovators, the policy environment in 2026 presents both opportunity and risk. They can leverage new evidence frameworks, engage earlier with regulators, and shape emerging policy conversations; however, they also face risks linked with unpredictability, misaligned incentives, and uncertainty around long‑term access and reimbursement.
Successful innovation will increasingly depend on industry partners with integrated strategies that connect regulatory planning, evidence development, policy engagement, and market access from the earliest stages of innovation.
For policymakers, the challenge is to modernize regulatory and coverage frameworks in ways that support innovation without sacrificing rigor, affordability, or public trust.
Connect with Us
As healthcare continues to evolve, one thing is clear: Innovation policy is no longer a niche concern. Rather, it is central to the future of access, outcomes, and system sustainability.
For further exploration of these issues, listen to HMA’s recent podcast on how evolving regulatory frameworks are shaping innovation, commercialization, and access across healthcare. The discussion features insights from Ben Shand of HMA and Julie Tierney of Leavitt Partners, whose combined experience spans senior roles within FDA and extensive collaboration with industry on complex regulatory and policy challenges. The conversation expands on the themes highlighted here, including regulatory predictability, evidence evolution, and strategies for navigating uncertainty across the product life cycle.
The takeaway is clear: Waiting until late in development to collaborate with regulators and policymakers is no longer a viable strategy. Organizations that engage earlier and more actively are better positioned to anticipate shifts, shape the conversation, and avoid costly misalignment between approval and coverage.
HMA can help you identify where the policy landscape is creating new opportunities and where risks may emerge. We work with organizations to develop proactive engagement strategies that align with today’s changing environment, especially when traditional approaches are no longer delivering results.
HMA Acquires HealthTech Solutions, Expanding Technology Capabilities and Medicaid Expertise
Acquisition Strengthens HMA’s Government Health Technology Services and Enhances Data, Analytics, and Compliance Offerings
OKEMOS, Mich., March 27, 2026 – Health Management Associates, (HMA), a national leader in health and human services consulting, today announced the acquisition of HealthTech Solutions, a premier provider of Medicaid-focused technology, analytics, and compliance solutions.
The acquisition of HealthTech Solutions enhances HMA’s capabilities in government health technology, adding advanced data, analytics, and systems modernization expertise to its established policy, regulatory, and operational advisory services. HealthTech’s specialization in Medicaid technology strengthens HMA’s ability to support state agencies with integrated solutions spanning strategy through technical implementation.
“HealthTech Solutions has an impressive track record of providing state-of-the-art IT solutions and strategic insights that deliver results for clients,” said Jay Rosen, HMA’s founder and current president and chairman. “Their expertise further expands the ways in which we can serve our clients now and into the future. We are excited to have HealthTech join the HMA team.”
“This acquisition marks an important step in HMA’s continued evolution as a comprehensive partner to state Medicaid agencies and government health programs. We are thrilled to welcome the talented HealthTech Solutions team to our distinguished group of colleagues,” said Chuck Milligan, chief executive officer of HMA. “HealthTech’s advanced technology platform, experienced leadership team, and strong client relationships enhance our ability to deliver innovative solutions that improve outcomes for the populations our clients serve.”
Sandeep Kapoor, co-founder and chief executive officer of HealthTech Solutions, added, “This acquisition marks an exciting new chapter for our company. Joining HMA will allow us to grow, expand the value we deliver to our clients, and build on the strong foundation we have created. At the same time, our commitment to excellence in service and products remains unchanged and will continue to be at the heart of everything we do.”
HealthTech Solutions will continue to operate as HealthTech Solutions, an HMA Company. Terms of the transaction were not disclosed. Synergy Advisors served as exclusive financial advisor to HealthTech Solutions in this transaction.
About Health Management Associates (HMA)
HMA is an independent, national research and consulting firm specializing in publicly funded healthcare and human services policy, programs, financing, and evaluation. We serve government, public and private providers, health systems, health plans, community-based organizations, institutional investors, foundations, and associations. With multidisciplinary consultants coast to coast, HMA’s expertise, services, and team are always within client reach.
About HealthTech Solutions
HealthTech Solutions is a leading provider of Medicaid-focused technology, analytics, and compliance solutions. With a modular cloud-based platform and a team of more than 300 professionals, HealthTech supports state agencies in systems modernization, reporting, and regulatory compliance initiatives.
Federal Policy News
Fueled By Leavitt Partners Weekly Health Intelligence
President’s FY 2027 Budget Set to Signal Healthcare Priorities
This week, Congress is awaiting the President’s budget request for Fiscal Year (FY) 2027, which will reportedly be sent to Congress by Friday, April 3. The President’s budget request includes spending level recommendations for each agency, as well as proposed new policies which Congress may consider, but is not required to adopt. The President’s budget request and subsequent budget justifications from HHS agencies will provide insight into the Administration’s priorities for healthcare, including policies to reduce waste, fraud, and abuse, and the continued implementation of the MAHA Strategy as well as information regarding how agencies are currently spending their appropriated funds for FY 2026.
The budget will also provide insight into the Administration’s effort to reorganize HHS, which was first announced in the FY 2026 budget request to Congress, but rejected by Congress in FY 2026 appropriations report language. Further, where the President proposed several spending reductions across HHS for FY 2026, including a 40 percent cut to NIH, Congress generally increased funding for HHS agencies, or kept funding level with FY 2025.
Traditionally, the HHS Secretary and other HHS agency officials testify before the healthcare authorizing and appropriations committee in support of the President’s budget request.
HHS and CMS Launch Federal Healthcare Advisory Committee
On March 26, HHS and CMS announced the members of the inaugural federal Healthcare Advisory Committee. The 18-member committee’s formation was first announced in August, alongside an open call for nominations from individuals and organizations. It will provide recommendations to HHS Secretary Robert F. Kennedy Jr. and CMS Administrator Dr. Mehmet Oz on opportunities to improve how care is financed and delivered across Medicare, Medicaid, CHIP, and the health insurance marketplace. Specifically, the committee will provide non-binding recommendations focused on:
- “Developing actionable policy solutions to prevent and better manage chronic disease;
- Advancing accountability for safety and outcomes while reducing unnecessary administrative burden;
- Expanding the use of real-time data to support a higher quality of care, speed up claims processing, and improve quality measurement;
- Enhancing care for vulnerable populations, including those served by Medicaid; and
- Strengthening Medicare Advantage sustainability, including modernizing risk adjustment and quality measurement.”
The members selected to be a part of the committee include health care executives, state health officials, and health technology innovators. Notably, multiple members have a background in value-based care. Members will serve two-year terms with meetings open to the public. While the first meeting has not yet been scheduled, the committee is expected to convene later this year, with meeting notices and public engagement opportunities to be published in the Federal Register and on the CMS website.
New Executive Order Restricts DEI Activities in Federal Contracting
On March 26, President Trump issued an Executive Order (EO) on “Addressing DEI Discrimination by Federal Contractors.” The EO seeks to restrict the ability of federal contractors to engage in “racially discriminatory DEI activities,” which the EO defines as “disparate treatment based on race or ethnicity in the recruitment, employment (e.g., hiring, promotions), contracting (e.g., vendor agreements), program participation, or allocation or deployment of an entity’s resources.” The EO directs all executive departments and agencies within 30 days to ensure that all contracts include a clause prohibiting contractors from engaging in “racially discriminatory DEI activities,” and allowing the government to cancel the contract in the event of noncompliance.
The EO also directs OMB to issue guidance to agencies related to the EO and to identify “economic sectors that pose a particular risk of entities engaging in racially discriminatory DEI activities based on current or past conduct” and to issue further guidance detailing “best practices” for contracting with entities in these sectors. Finally, the EO directs all agencies to review and report to the Assistant to the President for Domestic Policy regarding its compliance with the EO within 120 days of its issuance.
FDA Approves First Neurologic Treatment for Hunter Syndrome in Nearly 20 Years
On March 25, FDA approved Denali Therapeutic’s Avlayah (tividenofusp alfa-eknm), the first treatment, in nearly 20 years, for neurologic manifestations of Hunter syndrome (Mucopolysaccharidosis type II or MPS II). Hunter syndrome is a rare genetic lysosomal disorder in which sugar molecules accumulate within the lysosomes of cells, resulting in abnormalities in the skeleton, heart, respiratory system, brain, and other organs and affecting physical and mental development. Avlayah, an IV infusion administered once weekly, is approved for use in presymptomatic or symptomatic pediatric patients who have not yet developed advanced neurologic impairment. The product received multiple designations to incentivize rare disease drug development, including breakthrough, fast track, priority review, and orphan drug designations. The treatment was approved using the accelerated approval pathway based on a surrogate endpoint – reduction of cerebrospinal fluid heparan sulfate, which was determined to be reasonably likely to predict its clinical benefit. Results from a phase 1/2 single-arm trial of 47 pediatric patients were submitted, in which Avlayah demonstrated a 91 percent average reduction in cerebrospinal fluid heparan sulfate at week 24 with 93 percent of patients achieving levels below the upper limit of normal. Under accelerated approval, FDA requires a company to conduct a post market study to confirm clinical benefit. The randomized clinical trial to confirm clinical benefit of Aylayah is already more than 95 percent enrolled. FDA also granted Denali Therapeutics a Rare Pediatric Disease Priority Review Voucher (PRV). The approval comes as FDA has rejected several rare disease candidates in recent months, resulting in criticism from patient advocates, drug manufacturers, as well as members of Congress, including Senator Ron Johnsnon (R-WI), who previously stated that he planned to investigate FDA rejections of certain candidates for the treatment of rare diseases.
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State Policy News
Arizona
Arizona Launches RHTP Website; Grant Opportunities to be Posted April 2026. Arizona Governor Katie Hobbs announced on March 27, 2026, that the state has launched the Arizona Rural Health Transformation Program (RHTP) website. Arizona will post grant funding opportunities in April 2026, with all opportunities posted by May 2026 and awards expected by Summer 2026. Year 1 funding is targeted to be fully committed by October 30, 2026. The funding will be administered by the Arizona Health Care Cost Containment System (AHCCCS) in partnership with Arizona Department of Health Services (ADHS) and the Arizona Office of Economic Opportunity (OEO), targeting 786,000 individuals who live in rural communities. Arizona was awarded $167 million by the Centers for Medicare & Medicaid Services for RHTP.
Colorado
Colorado Medicaid Director Kim Bimestefer Resigns. The Colorado Sun reported on March 30, 2026, that the Colorado Department of Health Care Policy and Financing Executive Director Kim Bimestefer resigned as state lawmakers were preparing a vote of no confidence tied to concerns over program spending and management. The resignation follows heightened scrutiny over a $1.5 billion budget shortfall, proposed Medicaid cuts, and identified misspending, including improper payments for autism services and transportation billing errors.
Idaho
Idaho Delays Medicaid Managed Care Implementation to 2030. The Idaho Department of Health and Welfare announced that it will delay implementation of comprehensive Medicaid managed care to January 1, 2030. The department will release more information about the Request for Proposals timeline at a later date.
Nevada
Nevada Submits SPA to Update FQHC, RHC Medicaid Reimbursement Policies. The Nevada Health Authority submitted on March 25, 2026, a State Plan Amendment (SPA) to update Medicaid reimbursement policies for Federally Qualified Health Centers (FQHCs) and Rural Health Clinics (RHCs), with a proposed retroactive date of February 22, 2026. The amendment revises prospective payment system (PPS) rate methodologies to reflect statewide managed care requirements, clarifies use of alternative payment methodologies, and establishes processes for supplemental payments when managed care organization payments fall below PPS rates. It also adds provisions related to out-of-state FQHC rate setting and strengthens documentation submission timelines tied to rate review enforcement. State officials indicated the changes are administrative and not expected to have a fiscal impact.
Ohio
Ohio Launches Phase 2 of FIDE-SNP Implementation. The Ohio Department of Medicaid announced on April 1, 2026, that Ohio has expanded its Next Generation MyCare to 10 new counties as part of Phase 2 of the rollout. The program went live January 1, 2026, in the original 29 MyCare counties, transitioning out of the financial alignment initiative (FAI) demonstration model to a fully integrated dual eligible special needs plan (FIDE-SNP). The remaining counties will become available by August 1. Under Phase 2, additional supports to improve outcomes will also be available, including enhanced behavioral health services, expanded transportation and mobility supports, and strengthened long-term care and community-based living assistance. Current statewide plans are Elevance/Anthem, CareSource, and Molina; Centene/Buckeye will not be available for new members in 2026.
Our Insights
Fueled By Experts Across Our HMA Companies
Health Management Associates
Identifying Gaps in a Medicare Advantage Plan’s Quality Strategy for the Part D Benefit
Medicare Advantage (MA) plans are assuming bigger risk in their Part D benefit spending than in previous years due to recent changes in MA rules. Audits of the program, a requirement to participate in MA, will mean that there are increased compliance and operational risks in how plans go about serving their members with the Part D benefit. MA plans need to ensure alignment and collaboration across their organizations and with vendors to optimize initiatives in quality and Stars. In this case study, HMA explains how we use our diverse expertise in the Part D program – including operations, PBM and vendor oversight, health plan leadership, Stars and quality programs, financial and actuarial analysis, and compliance – to recommended a series of organizational changes and quality improvements to enable the client to optimize their Part D operations.
2026 Georgia State of Reform Health Policy Conference | April 15, 2026
The inaugural 2026 Georgia State of Reform Health Policy Conference will be taking place in-person on April 15th, 2026 at the Omni Atlanta Hotel at Centennial Park.
2026 Michigan State of Reform Health Policy Conference | May 5, 2026
The 2026 Michigan State of Reform Health Policy Conference will be taking place in-person on May 5th, 2026 at the Kellogg Hotel and Conference Center! Managing constant change in healthcare takes more than just hard work. It takes a solid understanding of the legislative process and knowledge about intricacies of the healthcare system. That’s where State of Reform comes in.
2026 Maryland State of Reform Health Policy Conference | May 21, 2026
The 2026 Maryland State of Reform Health Policy Conference will be taking place in-person on May 21st, 2026 at the Baltimore Marriott Waterfront! Managing constant change in healthcare takes more than just hard work. It takes a solid understanding of the legislative process and knowledge about intricacies of the healthcare system. That’s where State of Reform comes in.
Wakely
Platinum Plans – Strategic Design Opportunity or Repeat of Past Mistakes?
The 2027 Actuarial Value Calculator creates a timely opportunity for health plans to reintroduce Platinum products—not as broad offerings, but as targeted, condition-specific strategies that can materially improve margins on high-cost members already in their population. Historically abandoned due to adverse selection and inadequate risk adjustment, Platinum plans can now leverage higher premiums, stronger risk transfer dynamics, and reinsurance support to deliver better financial outcomes while enhancing member value. However, success is not automatic: plans must carefully design benefits and networks to avoid repeating past mistakes and unintentionally attracting disproportionate external risk.
Plans can leverage Wakely’s unique datasets and strategic expertise to understand when this approach works and how to design a winning Platinum strategy.
Implications of Proposed NBPP on Bronze Plans
The proposed 2027 NBPP introduces a significant shift in ACA marketplace dynamics by allowing Bronze plans with higher-than-standard out-of-pocket maximums, enabling ultra-low actuarial value designs and more aggressive pricing strategies. While these plans may improve affordability and attract healthier members, they also introduce meaningful uncertainty—premium reductions may outpace claims savings, risk adjustment transfers could shift unpredictably, and metal tier migration may disrupt established enrollment patterns. At the same time, regulatory discretion, potential legal challenges, and operational complexities add further risk to implementation.
RFP Calendar
RFP Calendar
| Date | State/Program | Event | Beneficiaries |
|---|---|---|---|
| Date: February 2026 - DELAYED | State/Program: Illinois | Event: Awards | Beneficiaries: 2,400,000 |
| Date: March 20, 2026 | State/Program: Hawaii Community Care Services | Event: Proposals Due | Beneficiaries: 5,500 |
| Date: April 10, 2026 | State/Program: Hawaii Community Care Services | Event: Awards | Beneficiaries: 5,500 |
| Date: May 1, 2026 | State/Program: Nevada Children's Specialty | Event: Proposals Due | Beneficiaries: NA |
| Date: May 12, 2026 | State/Program: Nevada CO D-SNP | Event: Awards | Beneficiaries: 88,000 |
| Date: June 24, 2026 | State/Program: Wisconsin LTC GSR 3 | Event: Awards | Beneficiaries: 56,000 (all GSR) |
| Date: Summer 2026 | State/Program: Illinois Foster Care | Event: RFP Release | Beneficiaries: 33,000 |
| Date: July 1, 2026 | State/Program: Hawaii Community Care Services | Event: Implementation | Beneficiaries: 5,500 |
| Date: July 28, 2026 | State/Program: Nevada Children's Specialty | Event: Awards | Beneficiaries: NA |
| Date: August 2026 | State/Program: Indiana | Event: RFP Release | Beneficiaries: 1,400,000 |
| Date: January 1, 2027 | State/Program: Illinois | Event: Implementation | Beneficiaries: 2,400,000 |
| Date: January 1, 2027 | State/Program: Nevada CO D-SNP | Event: Implementation | Beneficiaries: 88,000 |
| Date: January 1, 2027 | State/Program: Wisconsin LTC GSR 3 | Event: Implementation | Beneficiaries: 56,000 (all GSR) |
| Date: January 1, 2027 | State/Program: Illinois Tailored Care Management Program | Event: Implementation | Beneficiaries: 22,400 |
| Date: July 1, 2027 | State/Program: Nevada Children's Specialty | Event: Implementation | Beneficiaries: NA |
| Date: January 1, 2028 | State/Program: Wisconsin LTC GSR 4,6 | Event: Implementation | Beneficiaries: 56,000 (all GSR) |
| Date: Fall 2027 | State/Program: Oregon | Event: RFP Release | Beneficiaries: 1,200,000 |
| Date: 2028 | State/Program: North Carolina | Event: RFP Release | Beneficiaries: 2,200,000 |
| Date: 2029 | State/Program: California | Event: RFP Release | Beneficiaries: NA |