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FDA Issues Final Guidance on Biosimilar Prior Approval Supplements
09/10/2025
Grace Taylor, MS, MA
The US Food and Drug Administration (FDA) has finalized guidance clarifying 6 categories of biosimilar prior approval supplements, setting review goals that could shape timelines for new indications and payer coverage decisions.
The US Food and Drug Administration (FDA) has finalized guidance clarifying 6 categories of biosimilar prior approval supplements, setting review goals that could shape timelines for new indications and payer coverage decisions.
The US Food and Drug...
09/10/2025
First Report Managed Care
News
High Health Care Burden Among People with Hemophilia A Experiencing Bleeding or Joint Complications
09/10/2025
Juliet Gallagher
New real-world evidence shows that people with hemophilia A who experience bleeding or joint complications face significantly higher health care utilization and comorbidity burden.
New real-world evidence shows that people with hemophilia A who experience bleeding or joint complications face significantly higher health care utilization and comorbidity burden.
New real-world evidence shows...
09/10/2025
First Report Managed Care
News
Confronting the HIV Epidemic: Addressing Gaps in Access, Adherence, and Equity
09/02/2025
Juliet Gallagher
At a recent AMCP conference, health care leaders Maria Lopes, MD, and Steve Cohen, MD, highlighted the persistent and unique challenges of HIV management in the US, emphasizing that despite medical advancements, HIV remains classified as an...
At a recent AMCP conference, health care leaders Maria Lopes, MD, and Steve Cohen, MD, highlighted the persistent and unique challenges of HIV management in the US, emphasizing that despite medical advancements, HIV remains classified as an...
At a recent AMCP conference,...
09/02/2025
First Report Managed Care
News
Industry Payments and Their Role in MS Drug Selection Among High-Volume Prescribers
08/28/2025
Juliet Gallagher
A recent observational study explored the prevalence of industry payments to neurologists who prescribe multiple sclerosis (MS) disease-modifying therapies (DMTs), uncovering significant associations between such payments and prescribing...
A recent observational study explored the prevalence of industry payments to neurologists who prescribe multiple sclerosis (MS) disease-modifying therapies (DMTs), uncovering significant associations between such payments and prescribing...
A recent observational study...
08/28/2025
First Report Managed Care
News
Hochul’s Medicaid Spending Surges, With Persistent Focus on Quality by Experts
08/27/2025
Danielle Sposato
Governor Kathy Hochul has added $17 billion in new state Medicaid spending over four years, a 61% increase that outpaces all other state-funded programs combined. Despite this unprecedented investment, according to a newly published article...
Governor Kathy Hochul has added $17 billion in new state Medicaid spending over four years, a 61% increase that outpaces all other state-funded programs combined. Despite this unprecedented investment, according to a newly published article...
Governor Kathy Hochul has added...
08/27/2025
First Report Managed Care
News
Medicare Advantage Plans See Double-Digit Satisfaction Drop as Medical Costs Soar
08/22/2025
Juliet Gallagher
Member satisfaction with Medicare Advantage (MA) plans has seen a significant decline, according to J.D. Power’s 2025 report, reflecting a broader set of financial and policy pressures now facing the MA landscape.
Member satisfaction with Medicare Advantage (MA) plans has seen a significant decline, according to J.D. Power’s 2025 report, reflecting a broader set of financial and policy pressures now facing the MA landscape.
Member satisfaction with...
08/22/2025
First Report Managed Care
News
Medicare Advantage Plans See Double-Digit Satisfaction Drop as Medical Costs Soar
08/22/2025
Juliet Gallagher
Member satisfaction with Medicare Advantage (MA) plans has seen a significant decline, according to J.D. Power’s 2025 report, reflecting a broader set of financial and policy pressures now facing the MA landscape.
Member satisfaction with Medicare Advantage (MA) plans has seen a significant decline, according to J.D. Power’s 2025 report, reflecting a broader set of financial and policy pressures now facing the MA landscape.
Member satisfaction with...
08/22/2025
First Report Managed Care
News
Expanding Assertive Community Treatment to Transform Care for Complex Patients
08/20/2025
Lisa Kuhns, PhD, MD
A new study shows that health systems can rely on assertive community treatment (ACT), which has strong evidence supporting its effectiveness for treating the most complex, least engaged patients.
A new study shows that health systems can rely on assertive community treatment (ACT), which has strong evidence supporting its effectiveness for treating the most complex, least engaged patients.
A new study shows that health...
08/20/2025
First Report Managed Care
News
AAM White Paper Spotlights Legislative Path to Breaking Biosimilar Patent Barriers
08/18/2025
Grace Taylor, MS, MA
A recent white paper from the Association for Accessible Medicines exposes how brand-name drug patent tactics block biosimilar access and urges Congress to act on 3 key reforms to lower drug costs.
A recent white paper from the Association for Accessible Medicines exposes how brand-name drug patent tactics block biosimilar access and urges Congress to act on 3 key reforms to lower drug costs.
A recent white paper from the...
08/18/2025
First Report Managed Care
News
FDA Expands Approval of Alhemo for Hemophilia A and B Without Inhibitors
08/14/2025
Juliet Gallagher
Novo Nordisk has announced the US Food and Drug Administration (FDA) approval of Alhemo (concizumab-mtci) for use as a once-daily subcutaneous prophylactic treatment in people 12 years and older with hemophilia A or B (HA/HB) without...
Novo Nordisk has announced the US Food and Drug Administration (FDA) approval of Alhemo (concizumab-mtci) for use as a once-daily subcutaneous prophylactic treatment in people 12 years and older with hemophilia A or B (HA/HB) without...
Novo Nordisk has announced the...
08/14/2025
First Report Managed Care

Behind the Bill

Behind the Bill
The Senate’s $3 Trillion Deal. Tax Relief Now, Medicaid Coverage Loss Later?
07/02/2025
Katie Hayes, MJ
The Senate has done it. After weeks of behind-the-scenes wrangling and last-minute amendments, lawmakers have passed a sprawling tax-and-spending megabill that makes good on a long-standing Republican goal: making the 2017 Trump tax cuts...
The Senate has done it. After weeks of behind-the-scenes wrangling and last-minute amendments, lawmakers have passed a sprawling tax-and-spending megabill that makes good on a long-standing Republican goal: making the 2017 Trump tax cuts...
The Senate has done it. After...
07/02/2025
First Report Managed Care
Behind the Bill
When a Cap Isn’t Just a Cap: How a Provider Tax Proposal Could Reshape Medicaid Financing
06/25/2025
Katie Hayes, MJ
In Washington, the most consequential policies are often buried in the fine print. One such detail in the Senate Finance Committee’s latest tax and spending proposal would gradually cap provider taxes—a core funding tool states use to pull in...
In Washington, the most consequential policies are often buried in the fine print. One such detail in the Senate Finance Committee’s latest tax and spending proposal would gradually cap provider taxes—a core funding tool states use to pull in...
In Washington, the most...
06/25/2025
First Report Managed Care
Behind the Bill
Rewriting the Safety Net? Inside the Senate’s Changes to Medicaid and the ACA
06/18/2025
Katie Hayes, MJ
Over the past few weeks, I’ve been following the progress of the One Big Beautiful Bill Act (OBBBA), which started in the House with sweeping tax reforms and some eye-catching health care proposals. Now, the Senate has released its (highly...
Over the past few weeks, I’ve been following the progress of the One Big Beautiful Bill Act (OBBBA), which started in the House with sweeping tax reforms and some eye-catching health care proposals. Now, the Senate has released its (highly...
Over the past few weeks, I’ve...
06/18/2025
First Report Managed Care
Behind the Bill
How States Might Respond to the One Big Beautiful Bill Act
06/11/2025
Katie Hayes, MJ
With the One Big Beautiful Bill Act (OBBBA) still in the hands of the Senate, much of the national conversation has centered on what this legislation would do to federal coverage programs. But regardless of how the federal process unfolds,...
With the One Big Beautiful Bill Act (OBBBA) still in the hands of the Senate, much of the national conversation has centered on what this legislation would do to federal coverage programs. But regardless of how the federal process unfolds,...
With the One Big Beautiful Bill...
06/11/2025
First Report Managed Care
Behind the Bill
Is the Affordable Care Act on the Chopping Block? What the One Big Beautiful Bill Act Tells Us.
06/04/2025
Katie Hayes, MJ
It’s been weeks of headline-grabbing debate over Medicaid work requirements, and the “One Big Beautiful Bill Act” remains in the Senate as they deliberate over several health care provisions. While the Medicaid provisions sparked most of the...
It’s been weeks of headline-grabbing debate over Medicaid work requirements, and the “One Big Beautiful Bill Act” remains in the Senate as they deliberate over several health care provisions. While the Medicaid provisions sparked most of the...
It’s been weeks of...
06/04/2025
First Report Managed Care
Behind the Bill
From House to Senate: The Journey of Cutting Medicaid
05/28/2025
Katie Hayes, MJ
Last week, the House of Representatives narrowly passed the One Big Beautiful Bill Act (HR 1, 119th Congress) by a single vote, sending the sweeping tax and spending reconciliation package, backed by President Trump, to the Senate. With its...
Last week, the House of Representatives narrowly passed the One Big Beautiful Bill Act (HR 1, 119th Congress) by a single vote, sending the sweeping tax and spending reconciliation package, backed by President Trump, to the Senate. With its...
Last week, the House of...
05/28/2025
First Report Managed Care
Behind the Bill
Eligibility, Paperwork, and Penalties: The Not-So-Hidden Costs of Medicaid ‘Reform’
05/21/2025
Katie Hayes, MJ
It’s been another eventful week in health policy—a phrase that’s quickly becoming routine. This time, House Republicans advanced a sweeping budget reconciliation bill, designed to implement elements of the March budget resolution, with a...
It’s been another eventful week in health policy—a phrase that’s quickly becoming routine. This time, House Republicans advanced a sweeping budget reconciliation bill, designed to implement elements of the March budget resolution, with a...
It’s been another eventful week...
05/21/2025
First Report Managed Care
Behind the Bill
A Busy Week in Drug Pricing Policy: Aligning US Drug Prices With Global Standards?
05/14/2025
Katie Hayes, MJ
It’s been a busy few days for drug pricing policy. While I’d love to dig into the details of both President Trump’s latest executive order and the newest Republican bill that would cut Medicaid spending, we don’t have the time—and this isn’t...
It’s been a busy few days for drug pricing policy. While I’d love to dig into the details of both President Trump’s latest executive order and the newest Republican bill that would cut Medicaid spending, we don’t have the time—and this isn’t...
It’s been a busy few days for...
05/14/2025
First Report Managed Care
BEHIND THE BILL
When Agencies Lose Power: How 3 Seismic Shifts are Transforming Pharmaceutical Regulation
05/07/2025
Katie Hayes, MJ
In the span of just 9 months, the landscape of administrative law has undergone a transformation so profound that pharmaceutical executives, health care providers, and patients alike are struggling to navigate the new terrain. The Supreme...
In the span of just 9 months, the landscape of administrative law has undergone a transformation so profound that pharmaceutical executives, health care providers, and patients alike are struggling to navigate the new terrain. The Supreme...
In the span of just 9 months,...
05/07/2025
First Report Managed Care
Behind the Bill
The Medicare Paradox, Part 3: Strategic Trade Doesn’t Have to be a Zero-Sum Game
05/07/2025
Katie Hayes, MJ
Over the past 2 weeks, I’ve examined the growing friction between the Section 232 pharmaceutical tariff investigations and the Medicare drug pricing reforms authorized by the Inflation Reduction Act (IRA). These 2 policy agendas—industrial...
Over the past 2 weeks, I’ve examined the growing friction between the Section 232 pharmaceutical tariff investigations and the Medicare drug pricing reforms authorized by the Inflation Reduction Act (IRA). These 2 policy agendas—industrial...
Over the past 2 weeks, I’ve...
05/07/2025
First Report Managed Care

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Trending Articles

News
High Prevalence of Overlooked Demodex Blepharitis: Unraveling the Challenges in Diagnosis and Treatment
10/03/2023
Danielle Sposato
A comprehensive review of over 1,000 case records from 6 eye clinics revealed that Demodex blepharitis was prevalent in 57.7% of patients, regardless of their primary reason for the visit, aligning with similar rates reported in studies...
A comprehensive review of over 1,000 case records from 6 eye clinics revealed that Demodex blepharitis was prevalent in 57.7% of patients, regardless of their primary reason for the visit, aligning with similar rates reported in studies...
A comprehensive review of over...
10/03/2023
First Report Managed Care
Quiz
CDI Risk Factors
10/23/2023
What is the primary risk factor for Clostridioides difficile infection?
What is the primary risk factor for Clostridioides difficile infection?
What is the primary risk factor...
10/23/2023
First Report Managed Care
News
Bimekizumab is Safe and Effective in Treating Patients With Psoriatic Arthritis Native to Biologic Treatment, Study Finds
11/15/2023
Lisa Kuhns, PhD, MD
At week 16, 44% of patients receiving bimekizumab met the primary endpoint of 50% improvement in the American College of Rheumatology response criteria (ACR50) compared with 10% of those receiving placebo.
At week 16, 44% of patients receiving bimekizumab met the primary endpoint of 50% improvement in the American College of Rheumatology response criteria (ACR50) compared with 10% of those receiving placebo.
At week 16, 44% of patients...
11/15/2023
First Report Managed Care
News
Managing Treatment Burden in PsA and RA: Patients' Views on Methotrexate and TNFi Use
12/15/2023
Hannah Musick
“Patients experience a wide range of burden associated with treatments used for PsA and RA,” said researchers.
“Patients experience a wide range of burden associated with treatments used for PsA and RA,” said researchers.
“Patients experience a wide...
12/15/2023
First Report Managed Care
News
CMS Announces Increased Participation in ACO Initiatives to Improve Care for Medicare Patients
02/02/2024
Hannah Musick
The Centers for Medicare & Medicaid Services (CMS) has announced increased participation and investment in accountable care organization (ACO) initiatives to improve the quality of care for patients with Medicare and address disparities in...
The Centers for Medicare & Medicaid Services (CMS) has announced increased participation and investment in accountable care organization (ACO) initiatives to improve the quality of care for patients with Medicare and address disparities in...
The Centers for Medicare &...
02/02/2024
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