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Healthcare Regulatory Check-up Newsletter | March 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for March 2024. We summarize a US Court of Appeals for the Second Circuit decision interpreting the intent standard under the federal...more

What Makes a Patient a “Patient”? Court Rejects Restrictive 340B Definition

On November 3, 2023, the US District Court for the District of South Carolina issued a landmark order in Genesis Health Care, Inc. v. Becerra, a case analyzing the definition of a “patient” under the 340B Program Statute. The...more

HRSA Confirms 340B Off-Site Facility Policy, Delays Enforcement

On October 26, 2023, the Health Resources and Services Administration (HRSA) issued a Notice to “inform and remind” 340B Program covered entities that to be considered eligible for the 340B program, an off-site outpatient...more

HRSA Issues Notice Confirming 340B Registration Requirement

On October 26, the Health Resources and Services Administration (HRSA) published a Federal Register notice addressing the use of 340B drugs at off-campus hospital outpatient locations that have not yet appeared on a filed...more

CMS Pushes to Expand Hospital Price Transparency Requirements, Enforcement Activity

On July 26, 2023, two days after the Centers for Medicare and Medicaid Services (CMS) issued its second largest civil monetary penalty for noncompliance with the hospital price transparency rule, CMS hosted a webinar...more

Healthcare Regulatory Check-up Newsletter | June 2023 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for June 2023. We discuss several civil enforcement actions involving false claims, the Anti-Kickback Statute (AKS) and...more

CMS Releases Proposed Remedy for 340B-Acquired Drugs Purchased in CYs 2018–2022

On July 7, 2023, the Centers for Medicare and Medicaid Services (CMS) released the proposed rule, Hospital Outpatient Prospective Payment System: Remedy for 340B-Acquired Drugs Purchased for Calendar Years 2018–2022, to...more

Proposed Legislation Would Require Greater Transparency and Disclosure from Hospitals, Reduce Reimbursement to Certain Off-Campus...

Two bills are moving in the United States House of Representatives that have implications for hospitals and health systems, with material changes proposed regarding pricing transparency requirements, identification and...more

New York State Enacts Filing Requirement for Physician Practice Management and Physician Practice Transactions

On May 3, 2023, New York State enacted legislation that will require physician practice management services organizations (MSOs) and physician practices to submit a comprehensive filing to the New York State Department of...more

CMS Issues Medicare Drug Price Negotiation Initial Guidance, First Inflation Rebate List

On March 15, 2023, the Centers for Medicare and Medicaid Services (CMS) issued initial program guidance related to implementation of the Medicare Drug Price Negotiation Program. CMS requested public comments on selected...more

New York Proposes Regulatory Review of Physician Practice Transactions

On February 1, 2023, New York Governor Kathy Hochul announced the FY 2024 New York State Executive Budget, which included a proposal for the New York Department of Health (the Department) to review and approve material...more

Healthcare Regulatory Check-Up Newsletter | September 2022 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity between August 21 and September 20, 2022, including a guilty plea from a telemedicine physician who wrote prescriptions for...more

CMS Will Finalize Heightened Penalties, Additional Requirements Under Hospital Price Transparency Rule

On November 2, 2021, the Centers for Medicare and Medicaid Services (CMS) announced that it will implement increased penalties for hospitals that do not comply with the Hospital Price Transparency Rule, effective January 1,...more

CMS Proposes Heightened Penalties and Additional Requirements under the Hospital Price Transparency Rule

On July 19, 2021, President Joseph R. Biden’s administration released a proposed rule that would increase penalties for hospitals that do not comply with the Hospital Price Transparency Rule, effective January 1, 2022. The...more

HRSA Releases Final Rule Establishing Dispute Resolution Process for the 340B Program

On December 10, 2020, the Health Resources and Services Administration (HRSA) released a Final Rule to establish an administrative dispute resolution (ADR) process and ADR panels to resolve certain 340B Program disputes...more

HRSA Issues Proposed Rule Requiring Community Health Center Grant Recipients to Provide Certain Drugs to Low-Income Patients at...

On September 24, 2020, the Health Resources and Services Administration (HRSA) released a proposed rule that, if finalized, would require 340B-participating recipients of federal grants under Section 330(e) of the Public...more

White House Directs HHS to Model “Most-Favored-Nation” Price Caps for Part B and D Drugs

On September 13, 2020, the White House issued an Executive Order titled “Lowering Drug Prices by Putting America First” (the Executive Order), which directed the Secretary of the US Department of Health and Human Services...more

CMS Proposes Further OPPS Reductions to 340B Drug Reimbursement Rates

On August 4, 2020, the Centers for Medicare & Medicaid Services (CMS) released its CY 2021 Medicare Hospital Outpatient Prospective Payment System (OPPS) proposed rule. CMS proposes to reduce OPPS payments for 340B drugs from...more

DC Circuit Upholds OPPS Reimbursement Reductions for 340B Drugs

On July 31, 2020, the US Court of Appeals for the District of Columbia Circuit held that the Centers for Medicare and Medicaid Services (CMS) has authority under the Social Security Act to reduce Medicare payment rates for...more

HRSA Announces New Registration and Recertification Requirements for 340B Program

The Office of Pharmacy Affairs (OPA) of the Health Resources and Services Administration (HRSA) recently issued a new Program Update that includes new covered entity registration and recertification requirements, as well as...more

Federal District Court Upholds Hospital Price Transparency Rule; Implementation and Compliance Questions Remain

Background On November 15, 2019, the Centers for Medicare & Medicaid Services (CMS) issued a final rule (Final Rule) that requires hospitals to establish, update and make public a list of their standard charges for items and...more

CMS Releases 340B Drug Acquisition Cost Survey, Responses Due May 15, 2020

After receiving approval from the Office of Management and Budget (OMB) on April 23, 2020, the Centers for Medicare and Medicaid Services (CMS) released a survey on April 24, 2020, to collect information on 340B hospitals’...more

CMS Advances 340B Drug Acquisition Cost Survey to OMB and Solicits Final Comments Directly to OMB

On February 7, 2020, the Centers for Medicare and Medicaid Service (CMS) published a notice signaling that it has submitted its previously published September 2019 proposed survey of hospital 340B drug costs for Office of...more

GAO Recommends CMS, HRSA Improve 340B Duplicate Discount Oversight

On January 27, the Government Accountability Office (GAO) published a report concluding that the US Department of Health and Human Services (HHS) has provided limited oversight of the 340B and Medicaid Drug Rebate Programs,...more

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