EpiPen RICO Ruling Opens Door for Private AKS Enforcement
Part Two: The MFN Drug Pricing Rule and the Rebate Rule: Where Do We Go From Here?
Part One: Two new Medicare Drug Pricing Rules in One Day: What are the MFN and the Rebate Drug Pricing Rules?
Drug Pricing Initiatives During the Trump Presidency
Congress is back from a long August recess. However, it is only back for a few weeks. During this window, there is only one major thing Congress must do: extend government funding past the September 30 deadline through a...more
DOJ recently formed the Antitrust Division’s (the “Division”) Task Force on Health Care Monopolies and Collusion (“HCMC”), signaling anticompetitive activity in health care markets as an enforcement priority....more
Welcome to our fourth issue of The Health Record - our healthcare law insights e-newsletter. In this edition, we address a variety of topics including a recent SCOTUS ruling and the potential impact on CMS, issues of patient...more
On August 15, 2024, CMS announced the results of the first round of the negotiated prices between CMS and participating drug manufacturers for the 10 selected drugs under the Inflation Reduction Act’s (IRA) Medicare Drug...more
The July Monthly Minute considers the impact of the Supreme Court’s Loper decision in overturning the longstanding Chevron deference standard, along with a district court case awarding penalties for failing to produce plan...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
In the wake of the FTC’s July 9 vote to release an interim staff report on PBMs, several media outlets are reporting that the Commission is poised to sue large PBMs. The timing and nature of the litigation is unspecified,...more
Crafting a new pharmacy benefit manager (PBM) agreement may feel like an uphill battle when you do not have the time and resources to develop a highly customized contract. While it is often more beneficial to a health plan to...more
According to CMS, annual health care spending in the United States reached about $4.5 trillion in 2022, 9% of which (about $405 billion) was spent on prescription drugs.[1] CMS also reports that in 2022, 18% of annual health...more
Every year, the New Jersey legislature passes statutes that impact healthcare beyond rate increases under the Medicaid program. Last year was no different, and the discussion below highlights some of those statutes, such as...more
Section 340B of the Public Health Service Act has grown significantly since its enactment in 1992 – both in the number of covered entities eligible to participate and in the volume of drugs purchased through the program. The...more
On May 9, 2024, the DOJ announced the formation of a new task force on health care monopolies and collusion (the HCMC Task Force) that will “guide the division’s enforcement strategy and policy approach in health care,...more
House Energy & Commerce Health Subcommittee Holds Hearing on Cybersecurity. During the hearing, there was bipartisan concern about UnitedHealth Group’s response to the Change Healthcare cyberattack and consensus around the...more
The PBM regulatory landscape continues to evolve rapidly at both federal and state levels, making it critical for our clients involved in the PBM space to stay apprised of developments in the industry. Our team actively...more
Six months into the fiscal year, Congress has finally passed FY2024 appropriations. It was a painstaking process, which many expected to include policy victories that both sides could celebrate. Instead, the spring work...more
In August 2023, we published a blog post about the California Office of Health Care Access and Information’s (“OHCA”) proposed cost and market impact review (“CMIR”) regulations under the California Health Care Quality and...more
On March 13, 2024, Indiana joined the ranks of states exercising greater oversight and regulation of health care transactions. Senate Enrolled Act No. 9 (S.B. 9), which takes effect on July 1, 2024, requires written notice...more
Earlier this week, President Biden released his Fiscal Year (FY) 2025 President’s Budget. As a reminder, every year, the White House releases a budget that serves as its official funding request to Congress for the following...more
Although we are only two and a half months in, 2024 has already seen its fair share of impactful 340B developments on both the litigation and legislative fronts....more
In the final iteration of California’s Office of Health Care Affordability pre-closing health care transaction regulations, Health Care Entities that are party to a “material change transaction” closing on or after April 1,...more
As we predicted at the end of the 117th Congress, 2023 was a year of progress for advocates of Pharmacy Benefit Manager (PBM) reform. Abusive practices by PBMs received sustained, bipartisan focus in Congress throughout...more
IT’S SHUTDOWN WEEK . . . AGAIN - Stop us if you’ve heard this one before. Congress returns to session this week, with precious little time to avert a looming partial government shutdown at midnight on Friday. After...more
PARTIAL SNOW DAY, PARTIAL SHUT DOWN? Much of the federal government is closed today because of yesterday’s significant (for DC) and unexpected snowfall. However, part of the federal government is set to shut down this...more
In late December, the California Office of Health Care Affordability (OHCA) issued final regulations for the new material change transactions filing process, which goes into effect this year. (22 Cal. Code of Regs. §§...more
The Senate is back in session today, and the House comes back tomorrow. The beginning of 2024 is looking a lot like the end of 2023, with the big factor being the need to address government funding for fiscal year (FY) 2024....more