HRSA Notifies Six Drug Manufacturers of Referral to OIG for Possible Penalties
The Health Resources and Services Administration (HRSA) has taken additional steps to require 340B drug discounts when drugs are dispensed through contract pharmacies. On September 22, HRSA followed up on earlier letters to six manufacturers refusing contract pharmacy...
HHS Announces New $25.5B Round of COVID-19 Provider Funding Targeting Those Serving Vulnerable Communities
The Department of Health and Human Services (HHS) has announced the release of $25.5 billion in new COVID-19 funding for providers, including $17 billion to be distributed as Phase 4 of the Provider Relief Fund (PRF) and $8.5 billion in American Rescue Plan (ARP)...
CMS Releases Proposed Outpatient Prospective Payment System Rule, Continuing Several Controversial Policies
The Centers for Medicare & Medicaid Services (CMS) has released its proposed outpatient prospective payment system (OPPS) rule for calendar year 2022. To the disappointment of many in the hospital industry, the rule proposes to continue a pair of controversial...
CMS Releases Proposed Physician Fee Schedule Rule
On July 13, 2021, the Centers for Medicare & Medicaid Services (CMS) released its proposed physician fee schedule rule for calendar year 2022, which includes provisions extending and expanding certain telehealth flexibilities, delaying the penalty phase of the...
HRSA Withdraws Contract Pharmacy Advisory Opinion But Will Continue Enforcement of Statute, Including Pursuant to May 17 Letters
The Health and Resource Service Administration (HRSA) announced June 18, in connection with the ongoing AstraZeneca case, that is withdrawing its December 2020 contract pharmacy Advisory Opinion “to avoid confusion and unnecessary litigation.” Despite withdrawal of...
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...