Thomas Barker on Centers for Medicare & Medicaid Services (CMS)

Supreme Court Narrows Medicaid Beneficiaries’ Right to Sue: Key Takeaways from Medina v. Planned Parenthood South Atlantic

The Supreme Court of the United States has issued a significant healthcare decision in Medina v. Planned Parenthood South Atlantic, a case which will likely have far-reaching implications for Medicaid beneficiaries and...more

6/27/2025 / Appeals , Beneficiaries , Centers for Medicare & Medicaid Services (CMS) , Constitutional Challenges , Healthcare Reform , Medicaid , Planned Parenthood , SCOTUS , Statutory Interpretation

CMS Rescinds Post-Dobbs EMTALA Guidance, Raising New Questions for Emergency Departments

I. Key Takeaways - Federal enforcement under the Emergency Medical Treatment and Labor Act (EMTALA) may be changing after the Centers for Medicare & Medicaid Services (CMS) rescinded guidance issued under the Biden...more

6/23/2025 / Biden Administration , Centers for Medicare & Medicaid Services (CMS) , Constitutional Challenges , Department of Health and Human Services (HHS) , Dobbs v. Jackson Women’s Health Organization , EMTALA , Health Care Providers , Healthcare , Healthcare Reform , Hospitals , Preemption , Reproductive Healthcare Issues , SCOTUS , Trump Administration

HHS Under the Second Trump Administration

On February 11, 2025, President Trump signed Executive Order (E.O.) 14210, Implementing The President’s “Department of Government Efficiency” Workforce Optimization Initiative, which instructed the newly formed Department of...more

4/2/2025 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Executive Orders , Food and Drug Administration (FDA) , Healthcare , Healthcare Reform , Loper Bright Enterprises v Raimondo , Regulatory Reform , Rulemaking Process , Trump Administration

Department of Health and Human Services Seeks to Revise Rulemaking Policies

On Friday, February 28, 2025, the Department of Health and Human Services (HHS) issued a policy statement announcing changes to rulemaking processes for agencies within HHS. According to the statement, HHS is rescinding a...more

3/10/2025 / Administrative Procedure Act , Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Final Rules , Medicaid , Medicare , Regulatory Reform , Regulatory Requirements , Rulemaking Process

What President-Elect Trump’s Victory Means for Healthcare in 2025

Donald Trump will be the 47th President of the U.S. Not since 1892 has a President been elected to two non-consecutive terms, and his victory has helped Republicans pick up several critical seats in Congress. Senate...more

11/8/2024 / Centers for Medicare & Medicaid Services (CMS) , Congressional Committees , Department of Health and Human Services (HHS) , Donald Trump , Election Results , Healthcare , Healthcare Reform , Lame Duck Session , Legislative Agendas , Members of Congress , Presidential Elections , Regulatory Agenda , Senate Committees , Trump Administration

Chevron’s Demise—And What It Means for Healthcare and Life Sciences Companies

Since 1984, the “Chevron doctrine” had served as the bedrock of many regulatory actions by the U.S. Department of Health and Human Services (HHS) and other federal agencies. Under the doctrine, courts followed a two-step...more

7/3/2024 / Administrative Procedure Act , Centers for Medicare & Medicaid Services (CMS) , Chevron Deference , Food and Drug Administration (FDA) , Healthcare , Life Sciences , Loper Bright Enterprises v Raimondo , SCOTUS , Statutory Interpretation

CMS Issues Rule Implementing Medicaid Redetermination Policies

We’ve written recently about the process that states are undertaking to begin to wind down the Medicaid enrollment expansion that was necessitated by the enactment of the Families First Coronavirus Response Act in March of...more

12/12/2023 / Beneficiaries , Centers for Medicare & Medicaid Services (CMS) , Consolidated Appropriations Act (CAA) , Corrective Action Plans (CAPs) , Eligibility , Enrollment , Health Insurance , Healthcare , Healthcare Reform , Medicaid , New Rules

State Medicaid Redeterminations Following the End of the COVID-19 Era Continuous Enrollment Requirem

At the onset of the COVID pandemic in March of 2020, Congress made an important policy decision: continued access to health coverage was crucial, especially because, at the time, it was uncertain how the economy would...more

9/19/2023 / Centers for Medicare & Medicaid Services (CMS) , Consolidated Appropriations Act (CAA) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Due Process , Enrollment , Families First Coronavirus Response Act (FFCRA) , Health Insurance , Public Health , Redeterminations , SCOTUS , State Medicaid Programs

American Hospital Association et al. v. Becerra et al.: Supreme Court Rejects CMS Policy to Adjust Medicare Part B Payments for...

Earlier this week, the Supreme Court released its opinion in American Hospital Association et al. v. Becerra et al., a case that involves the proper method for the Medicare program to reimburse hospitals for outpatient drugs...more

6/17/2022 / American Hospital Association et al v Becerra Secretary Of Health And Human Services et al , Appeals , Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Health Care Providers , Hospitals , Medicare , Medicare Part B , Outpatient Prospective Payment System (OPPS) , Prescription Drugs , Remand , Remedies , Reversal , SCOTUS , Section 340B

Enforcing Medicaid’s Guarantee of Access to Prescription Drugs

Over the years, we’ve written about the difficulties in challenging the entitlement to Medicaid in the federal courts. In light of a series of Supreme Court decisions dating back to 1990, the pathway for an aggrieved Medicaid...more

3/15/2022 / Affordable Care Act , Beneficiaries , Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Food and Drug Administration (FDA) , Medicaid , Pharmaceutical Industry , Prescription Drugs

Supreme Court Will Hear Several Health Care Cases in 2022 Term

Recently, my colleague Regina DeSantis told you about the ongoing saga involving disputes between 340B contract pharmacies and pharmaceutical manufacturers. We often write about the 340B program on our blog because of the...more

7/20/2021 / Centers for Medicare & Medicaid Services (CMS) , Covered Entities , Drug Pricing , DSH , Hospitals , Medicaid , Medicaid Drug Rebate Program , Medicare , SCOTUS , Section 340B

Coverage of Routine Clinical Trial Costs Under the Medicaid Program

Right before the new year, we told you about some of the Medicaid-related provisions of the COVID relief package that was recently signed into law by President Trump. One provision of that law that we thought merited a...more

1/18/2021 / Centers for Medicare & Medicaid Services (CMS) , Clinical Trials , Consolidated Appropriations Act (CAA) , Coronavirus/COVID-19 , Healthcare , Medicaid , New Legislation , Trump Administration

Collecting Overpayments from Medicaid Providers

Today we want to address a topic that many state Medicaid agencies will no doubt be thinking about in the coming months, as the COVID-caused pandemic continues to threaten state finances and Congress has somewhat tied states’...more

1/11/2021 / Audits , Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Health Care Providers , MA Supreme Judicial Court , Medicaid , Social Security Act , WI Supreme Court

CMS Finalizes Changes to Medicaid Prescription Drug Rebate Program

Earlier this year, my colleague Ross Margulies and I told you about a new proposed rule issued by CMS that makes several changes to the Medicaid prescription drug rebate program, or the MDRP. Recently, CMS finalized the rule...more

1/5/2021 / Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , MDRP , Medicaid , Medicaid Drug Rebate Program , Pharmaceutical Industry , Prescription Drugs , Value-Based Purchasing

Medicaid Provisions in COVID-19 Relief Package

Here at the Medicaid and the Law Blog, we spent part of our holiday break reading through the most recent COVID-19 relief package that was finally signed into law by President Trump amid a not-insignificant amount of drama. ...more

12/30/2020 / Centers for Medicare & Medicaid Services (CMS) , Consolidated Appropriations Act (CAA) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Medicaid , New Legislation , Non-Emergency Medical Transportation (NEMT) , Supplemental Payments , Trump Administration

2020 MACStats Released by MACPAC

On December 16, 2020, the Medicaid and CHIP Payment and Access Commission (MACPAC) released its annual MACStats: Medicaid and CHIP Data Book for 2020. This document contains a wealth of information about the Medicaid and CHIP...more

12/18/2020 / Centers for Medicare & Medicaid Services (CMS) , Children's Health Insurance Program (CHIP) , MACPAC , Medicaid

CMS Prevails in Litigation Challenging Pricing Policy for 340B Drugs

We’ve written before about the 340B program, which allows some health service providers that treat low-income patients to purchase outpatient prescription drugs at deeply discounted prices. It’s related (at least...more

8/2/2020 / Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Health Care Providers , Low-Income Issues , Medicaid Drug Rebate Program , Prescription Drugs , Section 340B

Paying for Value in Medicaid Prescription Drug Coverage

My colleague Ross Margulies has already told our readers about a provision of the new proposed Medicaid regulation governing how the program pays for outpatient prescription drugs under the Medicaid Drug Rebate Program, or...more

7/6/2020 / Best Buy , Centers for Medicare & Medicaid Services (CMS) , Food and Drug Administration (FDA) , MDRP , Medicaid , Medicaid Drug Rebate Program , Prescription Drug Coverage , Value-Based Purchasing

The COVID-19 Pandemic and Implications for Medicaid

Since the COVID-19 pandemic began to seriously affect the United States in March, Congress has passed four major pieces of legislation to address the public health crisis. CMS has also jumped into action and has issued a...more

5/11/2020 / CARES Act , Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Medicaid , Medicare , New Legislation , Trump Administration

The COVID-19 Virus and Medicaid (UPDATED)

The global pandemic caused by the novel corona virus has certainly shaken up our normal way of life and will do so for the foreseeable future. Times like this reinforce the importance of public health insurance programs like...more

3/19/2020 / Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Emergency Orders , FMAP , Legislative Agendas , MACPAC , Medicaid , Medicare , Trump Administration , Waivers

Washington D.C. Appellate Court Upholds Prohibition on Medicaid Work Requirement Waivers

The Centers for Medicare & Medicaid Services (CMS) suffered a big loss in court last week. The United States Court of Appeals for the D.C. Circuit upheld a lower court ruling that blocked CMS from implementing one of the...more

2/20/2020 / Appeals , Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Medicaid , Medicaid Work Requirements , Social Security Act , Waivers

CMS Releases Block Grant Guidance: Answers to your FAQs

On January 30, 2020, the Centers for Medicare & Medicaid Services (CMS) issued its long awaited and highly anticipated State Medicaid Director Letter (SMD Letter) announcing the “Healthy Adult Opportunity” (HAO) initiative...more

2/5/2020 / Affordable Care Act , Block Grants , Centers for Medicare & Medicaid Services (CMS) , Medicaid , Medicaid Expansion , Medicaid Work Requirements , New Guidance , Prescription Drugs , Social Security Act

CMS Issues Guidance to States on 340B Duplicate Discounts

Late last year, we noted that the Massachusetts Medicaid program had proposed regulations to address issues related to the prohibition on duplicate discounts in the 340B program. The Massachusetts solution was relatively...more

1/23/2020 / Best Practices , Centers for Medicare & Medicaid Services (CMS) , Covered Entities , Department of Health and Human Services (HHS) , Discounts , Hospitals , HRSA , New Guidance , Pharmaceutical Industry , Prescription Drugs , Rebates , Section 340B

CMS Is Seeking Guidance on Medicaid Coverage for Children Provided Across State Lines

The Medicaid program generally has more generous coverage rules for children than for adults. For example, under the Early and Periodic Screening, Diagnostic and Testing (EPSDT) provisions of the Medicaid statute, if a...more

1/22/2020 / 21st Century Cures Act , Centers for Medicare & Medicaid Services (CMS) , Comment Period , Enrollment , EPSDT , Health Care Providers , Medicaid , Minors , Request For Information , Rural Areas

CMS Medicaid Fiscal Accountability Regulation Published

Earlier this week, CMS released for publication a proposed rule that would add some degree of transparency and oversight to the somewhat opaque world of Medicaid financing. It’s a topic that’s fascinated us here at the...more

11/18/2019 / Centers for Medicare & Medicaid Services (CMS) , Comment Period , Disproportionate Share Adjustments , Fee-for-Service , Health Care Providers , Health Insurance , Healthcare , Healthcare Reform , Medicaid , Proposed Rules , Social Security Act , State Budgets

Thomas Barker

Foley Hoag LLP

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