How Pfizer’s Warranty Program Gets Around Best Price?

On October 13th our friends over at STAT  broke the news [sorry, Paywall] about a “warranty” pilot program from Pfizer that offers both patients and health plans (including Medicare Part D plans) the opportunity to receive a refund for any amounts paid to purchase the company’s longstanding oral lung cancer therapy XALKORI when use is discontinued in the first three months for clinical reasons.… More

New State Health Official Letter Extends Post-PHE Processing Timelines, Implements Redetermination Requirement

We’ve previously discussed the numerous flexibilities CMS offered state Medicaid programs to respond to local outbreaks and address health concerns associated with the COVID-19 public health emergency (PHE).

Back in March 2020 (which feels like ages ago, right?) my colleague Tom discussed the enhanced 6.2% Federal Medical Assistance Percentage (FMAP) funding—authorized by the Families First Coronavirus Response Act (FFCRA) and amended by the CARES Act—including the continuous-enrollment requirement for beneficiaries who had been enrolled in Medicaid on or after March 18,… More

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 link between that program and the Medicaid prescription drug rebate program.

Well, we’re doing it again:  this time, because the U.S. Supreme Court just announced that it’s going to hear a dispute between some hospitals (340B covered entities) and CMS in the Court’s next term that starts in October. … More

Summer Reruns: ‘340B Contract Pharmacy Saga’ Back in the Spotlight as OGC Withdraws Advisory Opinion

Like the Brood X cicadas emerging from their 17-year chthonic slumber, summer 2021 saw the reemergence of something else set to dominate headlines: 340B contract pharmacies.  Given the link between the Medicaid drug rebate program and 340B, we at Medicaid and the Law cover relevant 340B topics for our readers.

Today, we are discussing the “340B Contract Pharmacy Saga” in light of the Department of Health and Human Services (HHS) Office of General Counsel’s (OGC’s) June 18 announcement withdrawing Advisory Opinion 20-06. … More

Congress Weighs a “Fallback” for Medicaid Coverage Gap

One of President Biden’s major health care goals is to close the “Medicaid coverage gap” – which refers to those states that have not expanded Medicaid eligibility under the Affordable Care Act (ACA). Until now, the principle strategy to accomplish this goal was to offer the 12 states that have failed to expand Medicaid a “carrot” to incentivize adoption. For example, the American Rescue Plan offered these states a sweetheart of a deal,… More

The Avon Nursing Case: A Lesson in Challenging Medicaid Rulemaking for Providers

Hello Everyone! My name is Tyrus Jackson and I am one of the summer associates for the Healthcare practice at Foley Hoag. I just finished my 2L year at the George Washington University Law School and have my MPH from GW’s School of Public Health.

Medicaid providers seeking to directly challenge HHS rulemaking recently found success in the 2nd Circuit.… More

Renewed Focus on Medicaid Home and Community-Based Services

Due to the COVID-19 pandemic, most people have spent considerably more time at home over the past year. For many, this meant long hours of Netflix binging, crossword puzzles, and the occasional zoom happy hour. But for some of the most vulnerable Americans, stay at home orders and social distancing have caused significant interruptions in access to health care services, including preventative doctor visits, medication management and nutritional services.… More

Advocates File Suit Over Tennessee Waiver – Dissecting the Complaint

On April 22, 2021 the Tennessee Justice Center and the National Health Law Program, representing thirteen (13) aggrieved Medicaid beneficiaries in the state of Tennessee, filed suit in the U.S. District Court for the District of Columbia against the U.S. Department of Health and Human Services (HHS) seeking to block the implementation of the TennCare III “modified block grant” 1115 waiver approved in the waning days of the Trump Administration.… More

Revocation of the “Public Charge” Rule

Readers of our blog know that Haider, Alex and I have a longstanding interest in the intersection of health care law and immigration law.  That’s important for our blog, especially because of the needs of the immigrant community to be able to access critical healthcare services through the Medicaid program.  Over the past couple of years, we’ve written extensively about a regulation published by the Department of Homeland Security (DHS) in 2019 that’s known as the “public charge” rule. … More

‘Objective Falsity’ and the FCA: An Ongoing Circuit Split

The False Claims Act (“FCA”) is a Federal statute originally enacted in 1863 as a response to fraud from defense contractors during the American Civil War. Under the FCA (31 U.S.C. §§ 3729 – 3733), it is a crime for any person to knowingly submit false or fraudulent claims for payment to the United States government.  Those who violate the FCA are liable for treble damages plus a per-claim monetary penalty (calculated to align with inflation). … More