Weekly Roundup -
April 1, 2026
Smart. Strategic. Essential.
Unmatched Healthcare Insights from 黑料不打烊,
Leavitt Partners & Wakely.
Featured:
黑料不打烊 Acquires HealthTech Solutions, Expanding Technology Capabilities and Medicaid Expertise
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Trending: In Focus
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鈥�world access and affordability.听
This article draws on insights from experts at 黑料不打烊, Inc. (黑料不打烊), and Leavitt Partners, an 黑料不打烊 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.听
These insights听underscore a central theme听in early听2026:听Innovation is advancing听faster than the听policy听frameworks designed to support it.听For developers, investors, payers, and policymakers alike, the challenge is no longer whether innovation is possible,听but whether regulatory and coverage pathways can evolve quickly and coherently enough to support it.听
A More Fragmented Policy Signal Environment听
Historically, federal health policy followed relatively formal and predictable channels鈥攔ulemaking, guidance documents, and established notice听and听comment processes. Today, innovators increasingly receive policy signals through nontraditional and informal mechanisms, including agency websites, journal articles, speeches, podcasts, and pilot initiatives.听
This听evolution in communication听and how we ingest information听has two implications.听
First,听it creates听greater uncertainty for market planning,听as policy direction听often听emerges听incrementally or indirectly.听In addition, the听higher stakes听are higher听for听understanding the federal regulatory environment. Organizations听that听closely track agency behavior, precedent, and internal norms are better positioned to distinguish meaningful change from repackaged status quo.听
For innovators operating on 10鈥�to-15-year development timelines, even modest policy volatility can materially affect听research and development (R&D)听investment decisions, pipeline prioritization, and commercialization strategies.听
Innovation听Is听Outpacing Traditional Evidence Models听
Scientific progress, especially听in rare disease therapies, advanced biologics, and precision medicine,听can both strain and challenge听traditional clinical trial paradigms. Small patient populations, heterogeneous disease pathways, and novel mechanisms of action are making large, randomized trials increasingly difficult or impractical.听
In response, federal regulators are signaling a broader openness to:听
- Real鈥�world evidence (RWE)听
- Natural history studies听
- Registries and longitudinal data听
- Biomarkers and intermediate endpoints听
These approaches are not new, but their expanding role reflects a recognition that traditional evidence hierarchies听alone are听no longer sufficient for evaluating next鈥�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.听
The implication for innovators听is that听evidence strategy can no longer be an afterthought. Developers must design programs that support regulatory approval听and听downstream coverage, pricing, and post鈥�market evaluation. It is possible for evidence frameworks听to听overlap, but they must remain听distinct.听
Regulatory Approval听Is听a听Midpoint听for听the听Innovator Product听Journey听
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,听durability of response,听and budget impact听because they听often听struggle to justify large upfront payments within their annual budgeting structure.听
This misalignment is particularly acute for听high-cost therapies with听long-term听benefits and products approved through accelerated or flexible pathways, where听long-term听value may听misalign with听short-term听payer budgeting cycles.听
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.听
Predictability and Durability Are Emerging Policy Priorities听
Looking听further听ahead听in听2026 and beyond, predictability听and durability鈥攏ot听just flexibility鈥攁re听emerging听as core听priorities for听industry and policymakers alike.听Flexibility is essential to support innovation,听but听durable policy frameworks,听particularly those听derived听from听statute,听offer greater confidence听in听long鈥�term investments.听
Several themes听will听likely听shape the next phase听for how听federal health policy听handles innovation:听
- Streamlining early clinical development, including first鈥�in鈥�human studies听
- Codifying successful regulatory pathways to ensure durability across听presidential听administrations听
- Clarifying expectations for post鈥�market evidence generation听
- Improving transparency and consistency in agency advice听
These efforts reflect a broader recognition that innovation ecosystems depend not just on scientific breakthroughs, but听also听on stable rules of the road.听
Why It Matters听
For healthcare innovators, the policy environment听in听2026 presents both opportunity and risk. They听can听leverage听new evidence frameworks, engage earlier with regulators, and shape emerging policy conversations; however,听they also听face risks听linked with听unpredictability, misaligned incentives, and uncertainty around long鈥�term access and reimbursement.听
Successful innovation听will increasingly depend on听industry partners听with听integrated strategies that connect regulatory planning, evidence development, policy engagement, and market access from the earliest stages of innovation.听
For policymakers, the challenge is to modernize regulatory and coverage frameworks in ways that support innovation without sacrificing rigor, affordability, or public trust.听
Connect with Us听
As healthcare continues to evolve, one听thing听is clear:听Innovation policy is no longer a niche concern.听Rather,听it is central to the future of access, outcomes, and system sustainability.听
For听further听exploration of these issues,听listen to 贬惭础鈥檚 recent podcast on how evolving regulatory frameworks are shaping innovation, commercialization, and access across healthcare. The discussion features insights from听Ben Shand听of 黑料不打烊 and听Julie Tierney听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听cycle.听
The takeaway is clear:听Waiting until late in development to听collaborate with听regulators and policymakers is no longer听a viable听strategy. Organizations that engage earlier and more actively are better positioned to听anticipate听shifts, shape the conversation, and avoid costly misalignment between approval and coverage.听
黑料不打烊 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鈥檚 changing environment, especially when traditional approaches are no longer delivering results.
黑料不打烊 Acquires HealthTech Solutions, Expanding Technology Capabilities and Medicaid Expertise
Acquisition Strengthens 贬惭础鈥檚 Government Health Technology Services and Enhances Data, Analytics, and Compliance Offerings
OKEMOS, Mich., March 27, 2026 鈥�听黑料不打烊, (黑料不打烊), 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听听enhances听贬惭础鈥檚听capabilities in government health technology, adding advanced data, analytics, and systems modernization expertise to its established policy, regulatory, and operational advisory services. HealthTech鈥檚 specialization in Medicaid technology strengthens 贬惭础鈥檚 ability to support state agencies with integrated solutions spanning strategy through technical implementation.
鈥淗ealthTech Solutions has an impressive track record of providing state-of-the-art IT solutions and strategic insights that deliver results for clients,鈥� said Jay Rosen, 贬惭础鈥檚 founder and current president and chairman. 鈥淭heir 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 黑料不打烊 team.鈥�
鈥淭his acquisition marks an important step in 贬惭础鈥檚 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,鈥� said Chuck Milligan, chief executive officer of 黑料不打烊. 鈥淗ealthTech鈥檚 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.鈥�
Sandeep Kapoor, co-founder and chief executive officer of HealthTech Solutions, added, 鈥淭his acquisition marks an exciting new chapter for our company. Joining 黑料不打烊 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.鈥�
HealthTech Solutions will continue to operate as HealthTech Solutions, an 黑料不打烊 Company. Terms of the transaction were not disclosed. Synergy Advisors served as exclusive financial advisor to HealthTech Solutions in this transaction.
黑料不打烊 黑料不打烊 (黑料不打烊)
黑料不打烊 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, 贬惭础鈥檚 expertise, services, and team are always within client reach.
黑料不打烊 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 Weekly Health Intelligence
President鈥檚 FY 2027 Budget Set to Signal Healthcare Priorities
This week, Congress is awaiting the President鈥檚 budget request for Fiscal Year (FY) 2027, which will听reportedly be听sent to Congress by Friday, April 3. The President鈥檚 budget request includes spending level recommendations for each agency, as well as proposed new policies which Congress may consider, but is not听required听to adopt. The President鈥檚 budget request and subsequent budget justifications from HHS agencies will provide insight into the Administration鈥檚 priorities for healthcare, including policies to reduce waste, fraud, and abuse, and the continued implementation of the听听as well as information regarding how agencies are currently spending their appropriated funds for FY 2026.听
鈥疶he budget will also provide insight into the Administration鈥檚 effort to reorganize HHS, which was first听听in the FY 2026 budget request to Congress, but听听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听generally increased听funding for HHS agencies, or kept funding level with FY 2025.听
鈥�Traditionally, the HHS Secretary and other HHS agency officials testify before the healthcare authorizing and appropriations committee in support of the President鈥檚 budget request.听
HHS and CMS Launch Federal Healthcare Advisory Committee
On March 26, HHS and CMS听听the members of the inaugural federal Healthcare Advisory Committee. The 18-member committee鈥檚 formation was first听听in August, alongside an open call for nominations from individuals and organizations.听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:听
- 鈥淒eveloping actionable policy solutions to prevent and better manage chronic disease;听
- Advancing accountability for safety and outcomes while reducing unnecessary administrative burden;听
- Expanding the use of real-time data to support a higher quality of care, speed up claims processing, and improve quality measurement;听
- Enhancing care for vulnerable populations, including those served by Medicaid; and听
- Strengthening Medicare Advantage sustainability, including modernizing risk adjustment and quality measurement.鈥�听
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听convene听later this year, with meeting notices and public engagement opportunities to be published in the Federal Register and on the CMS website.听
New Executive Order Restricts DEI Activities in Federal Contracting
On March 26, President Trump issued an听听on 鈥淎ddressing DEI Discrimination by Federal Contractors.鈥� The EO seeks to restrict the ability of federal contractors to engage in 鈥渞acially discriminatory DEI activities,鈥� which the EO defines as 鈥渄isparate 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鈥檚 resources.鈥� The EO directs all executive departments and agencies within听30 days听to ensure that all contracts include a clause prohibiting contractors from engaging in 鈥渞acially discriminatory DEI activities,鈥� and allowing the government to cancel the contract听in the event of听noncompliance.听
The EO also directs OMB to issue guidance to agencies related to the EO and to听identify听鈥渆conomic sectors that pose a particular risk of entities engaging in racially discriminatory DEI activities based on current or past conduct鈥� and to issue further guidance detailing 鈥渂est practices鈥� 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听regarding听its compliance with the EO within听120 days听of its issuance.
FDA Approves First Neurologic Treatment for Hunter Syndrome in Nearly 20 Years
On听March 25, FDA听听Denali Therapeutic鈥檚听Avlayah听(tividenofusp听alfa-eknm), the first treatment, in听nearly 20听years, for neurologic manifestations of Hunter syndrome (Mucopolysaccharidosis type II or MPS II).听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.听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 鈥� reduction of cerebrospinal fluid heparan sulfate, which was determined to be听reasonably likely听to predict its clinical benefit. Results from a phase 1/2 single-arm trial of 47 pediatric patients were听submitted, in which听Avlayah听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听post market听study to confirm clinical benefit. The randomized clinical trial to confirm clinical benefit of听Aylayah听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听Johnsnon听(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鈥�鈥痮n March 27, 2026,听that听the state has launched the Arizona Rural Health Transformation Program (RHTP) website.听Arizona will post grant funding opportunities in April 2026, with all opportunities posted by May 2026 and awards expected by Summer 2026.听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听786,000 individuals听who live in rural communities. Arizona was awarded $167 million by the Centers for Medicare & Medicaid Services for RHTP.听
Colorado
Colorado听Medicaid Director Kim听Bimestefer Resigns. The Colorado Sun鈥�鈥痮n March 30, 2026, that the Colorado Department of Health Care Policy and Financing Executive Director Kim听Bimestefer听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听$1.5 billion听budget shortfall, proposed Medicaid cuts, and听identified听misspending, including improper payments for autism services and transportation billing errors.听
Idaho
Idaho Delays Medicaid Managed Care Implementation to 2030. The Idaho Department of Health and Welfare鈥�鈥痶hat it will delay implementation of comprehensive Medicaid managed care to January 1, 2030.听The department will release more information about the Request for Proposals听timeline at a later date.
Nevada
Nevada Submits SPA to Update FQHC, RHC Medicaid Reimbursement Policies. The Nevada Health Authority听听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听establishes听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听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 on April 1, 2026, that Ohio has expanded its Next Generation听MyCare听to 10 new counties as part of Phase 2 of the rollout. The program went live January 1, 2026, in the original 29听MyCare听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,听additional听supports听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听assistance. Current statewide plans are Elevance/Anthem, CareSource, and Molina; Centene/Buckeye will not be available for new members in 2026.听
Our Insights
Fueled By Experts Across Our 黑料不打烊 Companies
黑料不打烊
Identifying Gaps in a Medicare Advantage Plan鈥檚 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听participate听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听optimize听initiatives in quality and Stars. In this case study, 黑料不打烊 explains how we use our diverse expertise in the Part D program 鈥� including operations, PBM and vendor oversight, health plan leadership, Stars and quality programs, financial and actuarial analysis, and compliance 鈥� 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,听2026听at the Omni Atlanta Hotel at Centennial Park.听
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,听2026听at the Kellogg Hotel and Conference Center!听Managing constant change in healthcare takes more than听just hard听work. It takes a solid understanding of the legislative process and knowledge about听intricacies听of the healthcare system.听罢丑补迟鈥檚听where听State听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. 罢丑补迟鈥檚 where State of Reform comes in.
Wakely
Platinum Plans 鈥� Strategic Design Opportunity or Repeat of Past Mistakes?
The 2027 Actuarial Value Calculator creates听a timely听opportunity for health plans to reintroduce Platinum products鈥攏ot 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听selection听and inadequate risk adjustment, Platinum plans can now听leverage听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.听听
Plans can leverage Wakely鈥檚 unique datasets and strategic听expertise听to understand when this approach works and how to design a winning Platinum strategy.听
Implications of Proposed NBPP on Bronze Plans
The proposed 2027 NBPP introduces a significant shift in ACA marketplace dynamics by allowing听Bronze听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鈥攑remium 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.听
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 |