Over the past few years, Congress has attempted to pass “federal PBM reform.” Members of Congress have held numerous hearings related to PBMs and introduced numerous bills seeking to regulate PBMs (we regularly track these...more
In April, CMS finalized its Contract Year (CY) 2026 Medicare Advantage and Part D Final Rule (Final Rule). With CMS releasing the 2026 Medicare Advantage and Part D Proposed Rule in December under the Biden Administration,...more
Over the past few weeks, we have been closely following the Trump administration’s restructuring of the Department of Health and Human Services (HHS), the major reduction in the department’s workforce (RIF), and its broader...more
5/6/2025
/ Budget Cuts ,
Centers for Disease Control and Prevention (CDC) ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Healthcare ,
Healthcare Reform ,
National Institute of Health (NIH) ,
OMB ,
Trump Administration
It’s no secret that President Trump, his Cabinet, and other executive branch leaders are prioritizing deregulatory activities over more historical federal governance approaches. Indeed, one of President Trump’s earliest...more
As spring arrived in the mid-Atlantic region, the Department of Health and Human Services (HHS) under Robert F. Kennedy, Jr. followed through with a previously announced Reduction in Force (RIF) that reduced the department’s...more
4/15/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Healthcare Reform ,
Involuntary Reduction in Force ,
Layoffs ,
Medicaid ,
Medical Devices ,
Medicare ,
Pharmaceutical Industry ,
Regulatory Oversight ,
Regulatory Reform
Earlier this month, the Centers for Medicare & Medicaid Services (CMS) released its 2025 Marketplace Integrity and Affordability Proposed Rule (Proposed Rule), proposing a number of enrollment and eligibility policies...more
3/25/2025
/ Affordable Care Act ,
Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
DACA ,
Department of Health and Human Services (HHS) ,
Enrollment ,
Federal Poverty Line ,
Gender Identity ,
Health Insurance ,
Healthcare Reform ,
Inflation Reduction Act (IRA) ,
Insurance Industry ,
Out-of-Pocket Expenses ,
Proposed Rules ,
Regulatory Agenda ,
Regulatory Reform ,
Regulatory Requirements
The 340B Drug Pricing Program (340B Program) is no stranger to controversy. We have previously covered the ongoing contract pharmacy legal battles and the new alternative dispute resolution process. And now, a new 340B hurdle...more
Commencing October 2024, CMS will start off-cycle revalidations of all Skilled Nursing Facilities (SNFs). As part of the revalidation process, SNFs must disclose the additional information required under CMS’ final rule,...more
The passage of the Inflation Reduction Act of 2022 (IRA) marked a significant milestone in Congress’s ongoing efforts to address escalating health care costs. While the IRA aims to rein in government spending on Medicare and...more
As part of its 2025 Medicare Advantage and Part D Final Rule (the Final Rule), the Centers for Medicare & Medicaid Services (CMS) made a number of enrollment changes impacting dual eligible special needs plans (DSNPs). The...more
On February 15, 2024, the Centers for Medicare and Medicaid Services (CMS) released the Medicare Prescription Payment Plan Draft Part Two Guidance (Part Two Guidance) as part of the Inflation Reduction Act’s (IRA) efforts to...more
Most of the recent focus around the implementation of the Inflation Reduction Act (IRA) by the press and the industry has been on the Medicare Drug Price Negotiation Program and its potential impact on manufacturers. But the...more
Today, the Centers for Medicare & Medicaid Services (CMS) released the first 10 drugs (“Listed Drugs”) that will be included in the Inflation Reduction Act’s Medicare Drug Price Negotiation Program (“Negotiation Program”)....more
Private equity (PE) ownership of health care providers is unquestionably under scrutiny by federal and state regulators. States are passing laws that either directly or indirectly target PE health care transactions. For...more
Continuing our series discussing the CY 2023 Medicare Advantage and Part D Final Rule (Final Rule), this post focuses on the D-SNP related provisions under the Final Rule. As we discussed, the Centers for Medicare & Medicaid...more
The Centers for Medicare & Medicaid Services (CMS) released its Final Rule on Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs (Final Rule) late last...more
At the end of March 2022, the Centers for Medicare & Medicaid Services (CMS) released guidance to drug manufacturers and states on reporting Medicaid Best Price under value based purchasing (VBP) arrangements (Medicaid Best...more
As we noted, Centers for Medicare & Medicaid Services (CMS) recently proposed its Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs rules (Proposed...more
At the end of September, the Departments of Health and Human Services (HHS), Labor, and Treasury (collectively, the Departments), along with the Office of Personnel Management (OPM), released Part II of its regulations...more
It’s finally here – the Drug Pricing Plan that President Biden ordered the Department of Health and Human Services (HHS) to produce by the end of August (the “Plan”) was released publicly by the Administration on September 9,...more
9/13/2021
/ Biden Administration ,
Biosimilars Action Plan (BAP) ,
BPCIA ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Medicaid Drug Rebate Program ,
Medicare Part B ,
Medicare Part D ,
MedPAC ,
Pharmaceutical Industry ,
Prescription Drugs
Earlier this month, CMS issued a final rule aimed at lowering drug prices and reducing out-of-pocket expenses in Medicare Advantage and Medicare Part D. This rule is the Administration’s latest effort to address prescription...more
5/29/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Electronic Prescribing ,
Final Rules ,
Gag Clauses ,
Medicare Advantage ,
Medicare Part D ,
Out-of-Pocket Expenses ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs
As of January 30, 2019, CMS lifted its temporary provider enrollment moratoria (“Enrollment Moratorium”) for home health agencies (“HHAs”) in Florida, Illinois, Michigan and Texas. The Enrollment Moratorium had prevented new...more
The Trump Administration is moving full speed ahead with its proposals under the Blueprint to Lower Drug Prices (the “Blueprint”). Earlier this week, the Centers for Medicare & Medicaid Services (“CMS”) released a proposed...more
10/17/2018
/ Advertising ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Direct to Consumer Sales ,
Disclosure Requirements ,
First Amendment ,
Food and Drug Administration (FDA) ,
Manufacturers ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Rules ,
Public Comment ,
Regulatory Agenda ,
Television Commercials
Last week, the Department of Health and Human Services – Office of Inspector General (“OIG”) released a portfolio report identifying multiple vulnerabilities in the Medicare Hospice Program (the “Hospice Portfolio Report”),...more
Earlier this month, the Centers for Medicare & Medicaid Services (CMS) released its 2018 Medicare Advantage and Part D Advance Notice and Draft Call Letter (“Draft Call Letter”). For the majority of the letter’s provisions,...more