SCOTUS Upholds Affordable Care Act in 7-2 Ruling
On June 17, 2021, the Supreme Court issued its long-anticipated decision in California v. Texas, upholding the Affordable Care Act once again in a 7-2 ruling. The Court did not reach the merits of whether the now $0 individual mandate penalty rendered the law...
Judge in AstraZeneca Lawsuit Denies Government’s Motion to Dismiss
A district court judge in Delaware issued an opinion denying the government’s motion to dismiss a lawsuit regarding a December 2020 Advisory Opinion issued by the Health and Resource Service Administration (HRSA). The judge concluded that the 340B statute is silent as...
HHS Updates Reporting Requirement for Provider Relief Fund Recipients
On June 11, 2021 the Department of Health and Human Services (HHS) published revised Reporting Requirements for recipients of Provider Relief Fund (PFR) payments. Notably, these revisions have impacted when funds must be used and reporting deadlines for some tranches...
Manufacturers Respond to HRSA 340B Cease and Desist Letter
On June 10, 2021, Eli Lilly became the third manufacturer to response to HRSA’s May 17th Cease and Desist letter on 340B drug pricing. The response details Eli Lilly’s rejection of HRSA’s reasoning in its Cease and Desist letter, arguing that the agency’s reasoning is...
HRSA Issues Cease and Desist Letters to Manufacturers Restricting Use of Contract Pharmacies
On May 17, 2021, the Health and Resource Service Administration (HRSA) issued letters to six pharmaceutical manufacturers requiring the entities to immediately cease an ongoing practice of withholding 340B pricing to covered entities utilizing contract pharmacies....
District Court Issues Decision on Medicare GME Rule with Favorable Impact on Plaintiff, and Potentially Other, Hospitals
A district court in Washington, DC ruled today that a regulation governing the weighting of fellows for purposes of determining certain hospitals’ Medicare resident caps and graduate medical education (GME) payments is unlawful. Originally issued by the Department of...
Summary of Changes to Medicare GME Rules Governing Per Resident Amount and Resident Full-Time Equivalent Caps in the Consolidated Appropriations Act of 2021
In the Consolidated Appropriations Act of 2021 (CAA), Congress enacted several important changes to the Medicare GME rules governing the calculation of teaching hospitals’ per resident amount (PRA) and full-time equivalent (FTE) resident caps in order to accommodate...
CMS Rescinds 10-year Extension of Texas 1115 Waiver
On April 16, 2021, CMS rescinded its approval of Texas’ 1115 waiver, citing insufficient justification for granting an emergency exemption to the public notice requirements.
Judge Enjoins 340B ADR Rule, But Only as Applied to Eli Lilly
A district court judge in Indiana today issued a narrow ruling enjoining the Department of Health and Human Services (HHS) from implementing a rule issued in December finalizing administrative dispute resolution (ADR) procedures for the 340B program. Eli Lilly argued...
District Judge in California Dismisses Hospital 340B Lawsuit
A district court judge in California today dismissed a lawsuit filed by several hospital associations seeking to ensure enforcement of 340B discounts when drugs are dispensed through contract pharmacies. The judge concluded that the lawsuit was premature, as no final...
CMS Rescinds 1115 Letters of Agreement Sent to States
On Feb. 12, 2021, CMS rescinded the Letters of Agreements sent to states January 4, declaring that the procedures outlined in the Special Terms and Conditions of the demonstration will apply to the termination of waivers.
CMS Approves 10-year Renewal of Florida’s 1115 Waiver
On January 15, 2021, CMS approved a 10-year renewal of Florida’s Section 1115 Medicaid wavier, including an extension of the State’s Low Income Pool.
CMS Approves 10-year Renewal of Texas 1115 Waiver
On January 15, 2021, CMS approved a 10-year renewal of Texas’ Section 1115 Medicaid waiver using emergency authority to bypass notice and comment requirements. The renewed waiver will extend and expand the state’s Uncompensated Care Pool and envisions the adoption of...
CMS approves new 10-year TennCare III waiver
On January 8, 2021, CMS approved a new 10-year TennCare III waiver establishing a fixed aggregate dollar cap on funding accompanied by increased flexibility to make program changes and an opportunity for shared savings.
CMS Releases Revised Managed Care Directed Payments Preprint Application
On January 8, 2021, CMS published a revised managed care directed payment preprint application as part of its new guidance on directed payments released the same day. The revised preprint incorporates additional questions and more detailed tables, many of which had...
CMS Releases New Guidance on Managed Care Directed Payments
On January 8, 2021, the Centers for Medicare & Medicaid Services (CMS) issued a State Medicaid Director Letter (SMDL) outlining additional guidance on Medicaid managed care directed payments, as well as a revised preprint form for use in seeking approval of...
CMS Requests States’ Signature of 1115 Waiver Agreement
On January 4, 2021, CMS requested that states with 1115 waivers sign a Letter of Agreement establishing restrictive procedural requirements for CMS to terminate their waivers.
HRSA Issues Advisory Opinion Concluding the 340B Statute Requires Discounts When Drugs Are Dispensed Through Contract Pharmacies
Following a series of disputes between drug manufacturers and participants in the 340B program over contract pharmacies, on December 30, 2020, the Health and Resource Service Administration (HRSA) issued Advisory Opinion 20-06, concluding that the plain meaning of the...