In this episode Victoria Hamscho, Andrew Ruskin, and Leah Richardson provide an update on key developments to the 340B Program. They discuss the effects of the Supreme Court’s decision earlier this year overturning 340B...more
In this episode, Andrew Ruskin, Leah Richardson, and Victoria Hamscho analyze the U.S. Court of Appeals for the Fourth Circuit’s recent decision in Genesis Healthcare v. Becerra. They discuss its potential impact on the...more
Since the publication of this alert, the United States Court of Appeals for the Fifth Circuit granted an emergency motion to stay enforcement of OSHA’s Emergency Temporary Standard, finding there is “cause to believe there...more
On 1 July 2021, the Department of Health and Human Services (HHS) opened the Provider Relief Fund Reporting Portal for funding recipients to start submitting information in accordance with the Post-Payment Notice of Reporting...more
On 2 July 2021, the Supreme Court announced that it has accepted the American Hospital Association’s (AHA) petition for certiorari in American Hospital Association v. Becerra. At issue is the Centers for Medicare and Medicaid...more
The Supreme Court issued its much-anticipated opinion in California v. Texas regarding the constitutionality of the Affordable Care Act (ACA), rejecting the third major challenge to the law. The Supreme Court held in a 7–2...more
On Friday, 11 June, the Department of Health and Human Services (HHS) released long-awaited updates to its reporting requirements for recipients of Provider Relief Fund (PRF) payments. HHS’s updated Post-Payment Notice of...more
On 9 April 2021, during a weekly economic briefing, President Biden announced his administration’s intent to establish and fund a new regulatory agency, named the Advanced Research Projects Agency for Health (ARPA-H), which...more
Safety net providers participating in the 340B Drug Pricing Program (340B Program) continue to grapple with drug manufacturers imposing restrictions on 340B contract pharmacy arrangements. In response to these actions, the...more
How far can an agency go to allow agency-developed policy objectives to supersede concerns about faithful adherence to the law? Similarly, how much should health systems and others regulated by Medicare be concerned about...more
On 23 December 2020, Judge Catherine Blake of the U.S. District Court for the District of Maryland granted the Pharmaceutical Research and Manufacturers of America (PhRMA) a 14-day nationwide temporary restraining order,...more
The U.S. Supreme Court recently issued a unanimous decision in Rutledge v. Pharmaceutical Care Management Ass’n, which supports the validity of state statutes that regulate reimbursement rates pharmacy benefit managers (PBMs)...more
12/23/2020
/ Drug Pricing ,
Employee Retirement Income Security Act (ERISA) ,
Health Insurance ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Preemption ,
Prescription Drug Coverage ,
Prescription Drugs ,
Rutledge v Pharmaceutical Care Management Association ,
SCOTUS
On Thursday, 10 December 2020, the Department of Health and Human Services (HHS), Health Resources and Services Administration (HRSA) issued a pre-publication copy of the long-awaited 340B Drug Pricing Program Alternative...more
On November 20, the Centers for Medicare & Medicaid Services (CMS) issued the Most Favored Nation (MFN) Model interim final rule (MFN Rule), implementing President Trump’s proposal to align drug prices in the United States...more
In this episode of Triage, Andrew Ruskin and Victoria Hamscho provide an update on recent developments in the 340B Program and, in particular, on two recent legal challenges covered entities brought in response to drug...more
12/3/2020
/ Covered Entities ,
Dispute Resolution ,
Drug Pricing ,
Health Care Providers ,
HRSA ,
Manufacturers ,
Medicaid ,
OMB ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Section 340B
On 20 November 2020, the Centers for Medicare and Medicaid Services (CMS) and the Department of Health and Human Services (HHS) Office of Inspector General finalized several rules from President Trump’s health care agenda...more
In this episode, Rebecca Schaefer and Victoria Hamscho discuss the impact of the ongoing COVID-19 pandemic on university research programs and public policy projections for a potential federal response. The presenters are...more
11/23/2020
/ Clinical Trials ,
Coronavirus/COVID-19 ,
Educational Institutions ,
Health and Safety ,
Infectious Diseases ,
Medical Research ,
Public Policy ,
Relief Measures ,
Remote Working ,
Research and Development ,
Universities
In this episode, Rebecca Schaefer and Victoria Hamscho provide an update on next month’s Supreme Court oral arguments in California v. Texas, a case in which the Court will be reviewing the constitutionality of key parts of...more
10/29/2020
/ Affordable Care Act ,
California v Texas ,
Constitutional Challenges ,
Health Care Providers ,
Health Insurance ,
Healthcare Reform ,
Individual Mandate ,
Oral Argument ,
Presidential Elections ,
Repeal ,
Tax Penalties
Covered entities participating in the 340B Drug Pricing Program (340B Program) continue to grapple with drug manufacturers’ actions to limit contract pharmacy access to 340B pricing....more
In recent weeks, several drug manufacturers have taken actions that impact covered entities participating in the 340B Drug Pricing Program (340B Program) and their contract pharmacies....more
In this episode of Triage, Leah D’Aurora Richardson and Victoria Hamscho discuss next month’s Supreme Court oral arguments in Rutledge v. Pharmaceutical Care Management Association, including its potential impact on nearly...more
On 31 July 2020, the U.S. Court of Appeals for the District of Columbia Circuit (D.C. Circuit) upheld the U.S. Department of Health and Human Services’ (HHS) decision to allow the Centers for Medicare and Medicaid Services...more
On July 24, 2020, President Trump issued four executive orders aimed at lowering drug prices. The executive orders direct the Secretary of the Department of Health and Human Services (HHS) to: Increase access to insulin and...more
The Health Resources and Services Administration (HRSA) recently indicated that it lacks authority to enforce 340B Drug Pricing Program (340B Program) guidance in response to Eli Lilly and Co.’s notice to 340B covered...more
In this episode, Richard Church, Andrew Ruskin, and Victoria Hamscho discuss recent developments in the 340B Drug Pricing Program, including recent actions by drug manufacturers to limit contract pharmacy access to 340B...more
7/23/2020
/ Covered Entities ,
Drug Pricing ,
Eli Lilly ,
Eligibility ,
Health Care Providers ,
Hospitals ,
HRSA ,
Merck ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Proposed Legislation ,
Reporting Requirements ,
Section 340B