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
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
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. ...more
While only slightly past the midway point of 2023, it has already been a busy year for developments in drug pricing. Notably, CMS released its final guidance in preparation for price negotiations and the first 10 drugs...more
After almost a year of negotiations among congressional Democrats and the White House, the Inflation Reduction Act of 2022 (IRA) was signed into law by President Biden on August 16, 2022. It passed in the US Senate by a vote...more
Congress ended a busy work period after passing the Inflation Reduction Act (IRA) last week. This Holland & Knight alert summarizes the healthcare provisions in the IRA and provides an outlook on health policy issues that may...more
Key Points - Patient outcomes studies suggest a clinical benefit of co-pay programs, and a negative impact of co-pay accumulator programs. Co-pay programs remain unavailable to participants in federal...more
Click the link below for our complete analysis of recent updates to the Stark Law and Anti-Kickback Statute and their impact on health care providers. ...more
Pharmaceutical Care Management Association (“PCMA”) lawsuit results in delayed implementation of Final Rule while Biden Administration review is ongoing - Pursuant to a Court Order, implementation of the U.S. Dept. Health...more
With the change of administrations typically comes a flurry of activity across all government agencies, and the same can be expected with the official start of the Biden Administration now well underway. What should...more
In November 2020, the Department of Health and Human Services (HHS) finalized a regulation aimed at lowering prescription drug prices and out-of-pocket spending for prescription drugs by excluding rebates on prescription...more
On November 20, President Trump held a press briefing at which he unveiled two long-awaited actions to reduce prescription drug costs. Both actions had been called for in Executive Orders he issued this summer. Although each...more
The Trump Administration recently announced two final rules that implement policy objectives to lower drug prices by tying certain Medicare Part B payments to prices paid by other countries and by replacing an anti-kickback...more
On 20 November 2020, the United States Department of Health and Human Services (HHS) Office of the Inspector General (OIG) released its final rule on drug rebates entitled “Removal Of Safe Harbor Protection For Rebates...more
On November 20, the Department of Health and Human Services (HHS) and HHS Office of Inspector General (OIG) issued a Final Rule to finalize a February 6, 2019 proposal stripping rebates received from drug manufacturers by...more
Before the COVID-19 pandemic derailed even the best-laid plans, the Trump Administration and Congress were focused on a different public health issue: drug pricing. For years, President Trump has targeted “Big Pharma” as...more
Final Rule largely tracks prior proposal to make significant changes to the Discount Safe Harbor and other regulatory safe harbors to the Federal Anti-Kickback Statute. The Department of Health and Human Services Office of...more
This week in Washington: Negotiations for COVID-19 stimulus package are ongoing; House and Senate are in recess....more
Prescription drug prices are one of the biggest drivers of rising health care costs. To address this issue, the Trump administration issued its Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to...more
On July 24, 2020, President Trump signed four Executive Orders related to drug pricing that direct the Secretary of Health and Human Services (HHS) to take a number of actions aimed at lowering prescription drug prices. These...more
The White House released three Executive Orders on July 24, 2020 setting forth policies that the Administration believes will “deliver lower prescription drug prices to American patients.” A fourth Executive Order tying...more
As reported here in February, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released two new significant proposed regulations that would have had a transformative effect on the drug...more
Below is Alston & Bird’s Healthcare Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more
• The Centers for Medicare & Medicaid Services (CMS) has announced a new Medicare Part D demonstration to address the potential implementation of a recent proposed rule that would exclude from anti-kickback safe harbor...more
The pharmaceutical industry invests billions in research and development. And as a result, the pharmaceutical industry has brought—and continues to bring—beneficial, life-saving, life-prolonging, life-enhancing, and...more
The federal Anti-Kickback Statute (AKS) prohibits the knowing and willful solicitation, receipt, offer or payment of any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, in return for or to...more