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
K&L Gates Triage: 340B Eligibility - Hospital Covered Entities
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for November 2023. We discuss several US Department of Health and Human Services (HHS) agency actions, including the new General...more
In June of 2022, the Supreme Court of the United States unanimously held in American Hospital Association v. Becerra that the United States Department of Health and Human Services (“HHS”) and the Centers for Medicare and...more
The Centers for Medicare & Medicaid Services (CMS) released a final rule on Nov. 2, 2023, detailing how the agency will remedy underpayments from 2018 to 2022 for drugs acquired via the 340B Drug Pricing Program. The final...more
CONGRESS - Senate Finance Committee Holds Markup on Better Mental Health Care, Lower-Cost Drugs, and Extenders Act. The bipartisan package includes Medicare and Medicaid extenders, provisions to expand the mental health...more
CONGRESS - House Ways & Means Chair Smith, House Energy & Commerce Chair Rodgers and Senate Finance Ranking Member Crapo Call for Withdrawal of Nurse Staffing Mandate. Rep. Smith (R-MO), Rep. Rodgers (R-WA) and Sen. Crapo...more
Sharpen your pencils and locate your reading glasses: the final Medicare payment regulations for calendar year (CY) 2024 will be released within the next week. In the last Regs & Eggs blog post, I discussed a major issue...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. ...more
The Department of Health and Human Services has published a proposed rule to address short payments on drug acquisition costs for 340B hospitals from 2018 to September 2022. On June 15, 2022, the Supreme Court unanimously...more
The Centers for Medicare & Medicaid Services (CMS) released the Hospital Outpatient Prospective Payment System: Remedy for 340B-Acquired Drugs Purchased in Cost Years 2018-2022 Proposed Rule on July 7, 2023. CMS has published...more
We hope that you, like Congress, enjoyed some time off last week and are ready to dive in—for a few days at least. As we previously reminded you, the House is only in session 12 days in July, then away for August recess, and...more
Inflation Reduction Act and Health Reform: The Centers for Medicare & Medicaid Services (CMS) is continuing its efforts to staff the new Medicare Drug Rebate and Negotiations group and has posted various related job openings....more
We have noted before the link between the Medicaid prescription drug rebate program and the 340B program. As we wrote in an earlier Client Alert, in June 2022, the U.S. Supreme Court struck down HHS’s Medicare payment cuts to...more
We follow up on our previous blog post concerning the U.S. Supreme Court’s unanimous ruling in favor of 340B hospitals. The Supreme Court previously held that “absent a survey of hospitals’ acquisition costs, HHS may not vary...more
The United States District Court for the District of Columbia granted plaintiffs’ motion to vacate the 2022 OPPS Rule’s 340B rates on a prospective basis, meaning that HHS will pay 340B hospitals the drug’s average sales...more
On June 15, 2022, after many years of ongoing litigation, the U.S. Supreme Court unanimously overturned a substantial Medicare Part B payment reduction to many 340B Program participating hospitals related to certain...more
In a recent unanimous decision, the Supreme Court found that the Centers for Medicare and Medicaid Services (“CMS”), part of the federal Department of Health and Human Services (“HHS”), erred when it significantly reduced...more
This is a big legal week for hospitals and health systems as the U.S. Supreme Court heard not one, but TWO different oral arguments related to federal government payments to hospitals and health systems. In both cases, the...more
On August 2, 2021, the Centers for Medicare and Medicaid Services (“CMS”) issued its hospital inpatient prospective payment system (“IPPS”) final rule (“Final Rule”) for fiscal year 2022. In addition to a number of other...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more
In July 2020, we discussed a ruling by the D.C. Court of Appeals upholding the Department of Health and Human Services’ (HHS) site-neutral payment rules. On Monday, June 28, 2021, the Supreme Court declined, without comment,...more
The last two weeks of June saw several key developments affecting the 340B Drug Pricing Program—a federal government program created in 1992 that requires pharmaceutical manufacturers to provide outpatient drugs to eligible...more
The US Supreme Court has announced that it will take up review of the decision by the US Court of Appeals for the District of Columbia Circuit upholding Medicare’s 2018 payment cuts to 340B drugs. The case will be closely...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 July 31, 2020, the D.C. Circuit Court of Appeals issued a decision reversing a lower court decision and upholding Medicare payment cuts to certain hospitals participating in the 340B drug pricing program that have been in...more