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 September 6, 2024, President Biden signed an Executive Order on Investing in America and Investing in American Workers (the “Order”), that, among other things, aims to provide “incentives for federally assisted projects...more
On August 15, the Centers for Medicare & Medicaid Services (CMS) released a Notice of Funding Opportunity (NOFO) for states participating in the Cell and Gene Therapy (CGT) Access Model. Under this model, CMS will negotiate...more
On July 31, the Centers for Medicare and Medicaid Services (“CMS”) published its mammoth proposed rule entitled “Medicare and Medicaid Programs: Calendar Year 2025 Payment Policies under the Physician Fee Schedule and Other...more
Eyes on Energy Tax Update is a regular publication of the Holland & Knight Renewable and Alternative Energy Tax Team that provides highlights of important developments. The Renewable and Alternative Energy Tax Team also...more
The Centers for Medicare & Medicaid Services (CMS) has released the calendar year (CY) 2025 Revisions to Payment Policies Under the Physician Fee Schedule (MPFS) and Other Revisions to Medicare Part B (CMS-1807-P) Proposed...more
On July 9, 2024, the Federal Trade Commission (“FTC”) released an interim report describing their ongoing study of pharmacy benefit managers (“PBMs”) and their impact on access to and affordability of medicines....more
Pennsylvania recently enacted two new insurance laws that significantly expand the permissible kinds of value-added products and services that may be provided by insurance licensees in general and the fees that may be charged...more
A few days ago, the Central District Court handed down its ruling in the lawsuit filed by Aviad Concrete and Clay Industries against Nesher Israel Cement Enterprises. The suit concerned Nesher’s rebate policy to its...more
Incentivizing construction of new rental homes is a key policy priority for Canadian governments. As discussed in an earlier post, the federal Department of Finance issued a news release on September 14, 2023 relating to...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
“Home Energy Rebates” program, which made available $8.8 billion in funds to help reduce US households’ energy bills. Separated into two rebate programs – the HOMES Rebate Program and the HEEHRA Rebate Program – Home Energy...more
For firms in the United States, the Inflation Reduction Act (IRA) has released a flood of funding for clean energy demonstration and deployment. Tens of billions of dollars in the form of direct grants and loans have been...more
In a previous article, we introduced the fundamental concepts of the yield restriction and rebate rules set out in the Internal Revenue Code and Treasury Regulations and how tax-exempt bonds may be affected by high interest...more
Over the past several years, legislators across the country have focused their attention on Pharmacy Benefit Managers (PBMs) due to concerns expressed over a variety of industry practices. To date, there has been legislation...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
Calls for Removal of Device Patents Listed in the Orange Book Continue. FTC and Congressional action scrutinizing allegedly “improper” Orange Book listings continued apace in the first few months of 2024. ...more
In recent remarks prepared for delivery to the White House roundtable on pharmacy benefit managers (PBMs), Federal Trade Commission (FTC) Chair Lina Khan made clear that the FTC’s investigation into PBM practices continues....more
Insulin costs lowered to $35 dollars per month for many patients this year as three major insulin manufacturers — Sanofi, Novo Nordisk, and Eli Lilly — began offering price caps or savings programs.[1] This strategy was...more
On November 17, 2023, the Department of Energy Office of State and Community Energy Programs (DOE OCEP) announced the final program requirements for the Tribal Home Electrification and Appliance Rebates Program (the “Tribal...more
If there was any doubt that the late-2023 confirmation of Anna Gomez as the fifth commissioner would bring a flurry of FCC activity in 2024, the FCC has laid those questions to rest. In addition to a $150,000 good faith NAL,...more
The Centers for Medicare and Medicaid Services (CMS) continues to take steps implementing the Inflation Reduction Act of 2022 (IRA). Newly revised guidance issued on December 14, 2023, makes notable changes and clarifications...more
The Inflation Reduction Act (IRA) was signed into law in August 2022 with the goal of curbing inflation by, among other things, lowering prescription drug prices. Notable prescription drug provisions of the IRA include the...more
This dispute arose when the Canada Revenue Agency (“CRA”) reassessed President’s Choice Bank (“PCB”) for uncollected GST/HST on bundled supplies made to a major Canadian bank (the “Bank”) and denied the Bank’s rebate claims...more
The American Gas Association (“AGA”) issued a report titled: Natural Gas Efficiency Programs Report 2020 Program Year (“Report”) The Report Is authored by Miles Vondar and Morgan Hoy....more
Maintaining independence is fundamental for people living with disabilities. Having mobility options allows people with certain disabilities to go to doctor’s appointments, grocery shop, visits friends, and keep a sense of...more