Category Archives: Litigation

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

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

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

The Availability of a Private Right of Action in Medicaid

A few years ago, we told you about the “ongoing saga” surrounding the ability of a Medicaid beneficiary or a provider of health care services to a Medicaid beneficiary to challenge a state Medicaid agency’s putative violation of a requirement of the Medicaid program.  For example, section 1902(a)(8) of the Social Security Act says that a state Medicaid agency must provide Medicaid benefits “with reasonable promptness to all eligible individuals.”  Well,… More

A Loss in SCOTUS Prompts New CMS Notice of Proposed Rulemaking

Before getting into the weeds of how notice-and-comment rulemaking requirements interact with CMS’s ability to set payment policy – Medicaid and the Law would like to formally introduce its readers to Alexander Somodevilla (Alex), a new Associate in the Washington, DC office who will become a regular contributor to the blog. Alex has a deep background in Medicaid and Medicare law and policy, and is passionate about the issues and far-reaching impact of these programs.… More

CMS Prevails in Litigation Challenging Pricing Policy for 340B Drugs

We’ve written before about the 340B program, which allows some health service providers that treat low-income patients to purchase outpatient prescription drugs at  deeply discounted prices.  It’s related (at least tangentially) to our blog because of the link between the 340B program and the manner in which the Medicaid program pays for outpatient drugs; essentially, the price that a 340B covered entity pays for a drug is the price that Medicaid would pay for the drug when it’s dispensed to a Medicaid patient:  at least 23.1% off of the manufacturer’s price of the drug.… More

Supreme Court, in a Close Vote, Stays the Injunctions on the Public Charge Rule — UPDATED

UPDATED 2.25.2020 to reflect decision in Wolf v. Cook County, Illinois

Last summer, we wrote about the Department of Homeland Security’s (DHS) public charge rule.  As a reminder, that rule added some definition to the grounds of inadmissibility to the United States because of the likelihood that an applicant for an immigration benefit – such as a green card applicant or an individual seeking a visa to enter the United States – is likely to become a “public charge.”  We’re interested in that here at the Medicaid and the Law Blog because one of the factors that the final regulation would consider is whether the applicant has ever used Medicaid in the past or was likely to do so.… More

Washington D.C. Appellate Court Upholds Prohibition on Medicaid Work Requirement Waivers

The Centers for Medicare & Medicaid Services (CMS) suffered a big loss in court last week.  The United States Court of Appeals for the D.C. Circuit upheld a lower court ruling that blocked CMS from implementing one of the hallmarks of the Trump Administration’s efforts to restructure the Medicaid program.  We first wrote about the agency’s attempts to require some Medicaid recipients to participate in community engagement activities back in 2018. … More

D.C. Circuit Reverses District Court in DSH Case

We have long covered the handful of lawsuits that have been filed over the past several years concerning Medicaid disproportionate share hospital (“DSH”) payment policies.  These lawsuits all revolve around some steps that CMS had taken in recent years to exclude payments made for dual-eligible (Medicaid and Medicare) patients and payments made by private insurers from DSH hospitals’ uncompensated care costs.  CMS promulgated a rule to this effect,… More