Enforcing Medicaid’s Guarantee of Access to Prescription Drugs

Over the years, we’ve written about the difficulties in challenging the entitlement to Medicaid in the federal courts. In light of a series of Supreme Court decisions dating back to 1990, the pathway for an aggrieved Medicaid beneficiary or provider of services to a Medicaid beneficiary to challenge a state Medicaid plan’s alleged violation of a requirement of the Medicaid program has become increasingly narrow.… More

Oregon’s New Waiver Request to Exclude Accelerated Approval Drugs from Medicaid Coverage

Hello readers! Today’s post focuses on a topic we’ve touched on a few times in the past – Medicaid drug formularies.

Back in December 2021, the state of Oregon released a draft Medicaid waiver proposal that caught the attention of many stakeholders. In the draft proposal, Oregon stated that it was considering asking CMS for approval to a) adopt a commercial-style closed drug formulary and b) exclude from Medicaid coverage certain drugs approved via the accelerated approval pathway “with limited or inadequate evidence of clinical efficacy.” Oregon proposed to “use its own rigorous review process to determine coverage of new drugs and to prioritize patient access to clinically proven,… More

Georgia Files Suit Against CMS for “Regulatory Bait and Switch” Over its Expansion Population

Before jumping into the latest litigation over Medicaid waivers, Medicaid and the Law would like to introduce its readers to Adam Schilt. Adam is a healthcare associate in the Washington, DC office and will be a regular contributor to the blog. In a past role, he’s written pieces of legislation that have been enacted into the Medicaid statute and continues to be very passionate about the subject,… More

Justice Breyer’s Influence on America’s Health Care System

This week’s news that Justice Stephen Breyer would step down from the Supreme Court at the conclusion of the Court’s term definitely caught our attention here at the Medicaid and the Law Blog.  Our view is that Justice Breyer – who, for whatever reason, did not get a significant amount of attention from the mainstream media – had a monumental influence on the American health care system,… More

Supreme Court Hears Arguments on 340B Outpatient Payment Cuts—and Discusses ‘Chevron Deference’

Over the summer, my colleague Tom Barker discussed how the Supreme Court was planning to hear several health care cases during the October 2021 term.  Last week, the Court heard oral arguments for two noted cases: during Monday’s (November 29) arguments for Becerra v. Empire Health Foundation, the Court was asked to decide if the Administrative Procedure Act (APA) gives HHS authority to interpret the Medicare statute and recalculate payments made to disproportionate share hospitals (DSH);… More

District Courts Issue Key Decisions in 340B Contract Pharmacy Cases

Update: On November 10, 2021 Eli Lilly filed a notice of appeal in the case Eli Lilly and Company v. Becerra case challenging the October 29th decision by the Southern District of Indiana.

Over the last two weeks we have seen a flurry of activity from U.S. District Courts across the country in the ongoing contract pharmacy disputes between pharmaceutical manufacturers and HRSA,… More

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