THE ACCIDENTAL ENTREPRENEUR PART V video
THE ACCIDENTAL ENTREPRENEUR PART V Podcast
Health Reimbursement Arrangement Update
Podcast: Health Reimbursement Arrangements
K&L Gates Triage: 340B Update: CMS Finalizes 340B Program Reimbursement Cut on Part B Drugs
K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
On November 2, 2023, the Centers for Medicare and Medicaid Services (CMS) finalized the rule Medicare Program; Hospital Outpatient Prospective Payment System: Remedy for the Calendar Years 2018–2022 to addresses how the...more
On June 27, 2023, Connecticut Governor Ned Lamont signed into law Public Act 23-171“An Act Protecting Patients and Prohibiting Unnecessary Health Care Costs” (Act), which includes changes to the state’s implementation of the...more
The Centers for Medicare & Medicaid Services ("CMS") recently announced its proposal to make a one-time lump sum payment of roughly $9 billion to 340B-covered entity hospitals that were impacted by the agency's unlawful...more
The end of 2021 brings positive indications of the continued acceptance of telehealth as an important clinical care approach post public health emergency (“PHE”). The Centers for Medicare and Medicaid Services (“CMS”), like...more
On July 1, 2021, the Departments of Health and Human Services (“HHS”), Treasury, and Labor, along with the Office of Personnel Management (collectively the “Departments”), issued the first tranche of regulations implementing...more
On August 12, 2021, a panel of the Seventh Circuit voting 2-1 endorsed the existence of an “objective reasonableness” defense under the FCA. United States ex rel. Schutte v. SuperValu, Inc., No. 11-cv-3290, 2021 WL 3560894...more
Last week, Hogan Lovells partners Alice Valder Curran, Jodi K. Scott, and Jon Layman convened with other industry leaders virtually at this year’s Biotech and Digital Medicine Showcase Investor Conference to discuss how the...more
Most Favored Nations Model will alter how certain Medicare Part B drugs are reimbursed. The Centers for Medicare & Medicaid Services (CMS) released an advance copy of an interim final rule with a comment period announcing...more
Tuesday, 24 November 2020 - U.S. President-elect Joe Biden has pledged to expand the role of the federal government in response to the COVID-19 public health emergency, build on the Affordable Care Act, and continue drug...more
In this week’s episode, Darlene Davis, Andrew Ruskin, and Gabriel Scott discuss notable recent developments for reimbursement under the Hospital Outpatient Prospective Payment System (“OPPS”) of drugs purchased under the 340B...more
In the 2018 Hospital Outpatient Prospective Payment System (HOPPS) final rule, CMS finalized a policy to reduce payment for separately payable outpatient drugs purchased by certain hospitals under the 340B program from...more
Update: Following the court’s decision in May 2019, both the plaintiff hospitals and HHS filed further motions in the case – the plaintiffs moved for a firm date by which HHS must propose a remedy to the court. HHS moved for...more
On January 8, 2019, California Governor Gavin Newsom issued an executive order requiring all state agencies to consolidate into a single drug purchasing entity that will negotiate with pharmaceutical companies together....more
As K&L Gates begins its third season of Triage: Rapid Legal Lessons for Busy Health Care Professionals, Hilary Bowman previews several topics that the health care practice group anticipates will have a significant impact on...more
On December 27, 2018, the U.S. District Court for the District of Columbia issued an opinion that ruled against the Trump Administration in its plan to cut funding from the 340B Drug Pricing Program (“340B Program”). ...more
On December 27, 2018, the District Court for the District of Columbia issued a decision in American Hospital Association, et al. v. Azar, No.18-2084(RC) (D.D.C. December 27, 2018), holding that the cuts imposed by the...more
Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product's success or failure could cost you millions of dollars....more
On November 2, 2018, CMS issued the CY 2019 OPPS/ASC Final Rule, further cutting reimbursement for 340B Program purchased drugs. CMS finalized its proposed rule and expanded the reimbursement reductions for separately-payable...more
It is a time of change in the 340B Program. Manufacturers should closely monitor 340B Program developments and prepare to respond promptly and effectively to changes in legal requirements. This may make it necessary to devote...more
On July 17, 2017, the U.S. Court of Appeals for the District of Columbia Circuit ruled in favor of the Department of Health and Human Services (HHS), finding that the American Hospital Association’s (AHA) legal challenge of...more
The Office of Inspector General (OIG), Health and Human Services issued an Advisory Opinion allowing an arrangement proposed by a federally qualified health center look-alike (FQHC look-alike) to provide free technology items...more
Innovation in the life sciences and health care industries is occurring at a dizzying pace. Five years ago, anti-PD-1 antibodies from Merck and BMS had yet to be approved, CAR-T therapies were still in small-scale clinical...more
On February 12, 2018, the White House Office of Management and Budget released an overview of the president's Fiscal Year (FY) 2019 Budget (the Budget), which makes, among many others, several proposals regarding drug pricing...more
On November 1, 2017, CMS issued a final rule that became effective January 1, 2018, under which hospitals serving a disproportionate share of low-income patients (DSH hospitals) will receive nearly 27 percent less in...more
In November of last year, we wrote about a preliminary injunction being sought by hospital advocacy groups attempting to stop implementation of the Trump administration’s cuts to the 340B Drug Pricing Program (“340B...more