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
4/24/2024
/ Anti-Kickback Statute ,
Appeals ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Legislative Agendas ,
OIG ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Regulatory Reform ,
Stark Law
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
11/17/2023
/ Covered Entities ,
Enforcement Actions ,
Genesis HealthCare ,
Healthcare ,
Healthcare Reform ,
HRSA ,
Litigation Strategies ,
MDRP ,
Patients ,
Rulemaking Process ,
Section 340B
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
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
10/30/2023
/ Coronavirus/COVID-19 ,
Covered Entities ,
Health Care Providers ,
Healthcare ,
Hospitals ,
HRSA ,
Medicare ,
Minors ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health Emergency ,
Registration Requirement ,
Section 340B
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
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
7/31/2023
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Justice (DOJ) ,
Emerging Technologies ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Health Information Technologies ,
Healthcare ,
Healthcare Fraud ,
Medicare ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Securities and Exchange Commission (SEC) ,
Telehealth ,
Telemedicine
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
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
6/12/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Disclosure Requirements ,
Drug Pricing ,
Health Care Providers ,
Hospitals ,
MCOs ,
Medicaid ,
Price Transparency ,
Proposed Legislation ,
Reimbursements
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
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
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
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
10/7/2022
/ Advisory Opinions ,
Anti-Kickback Statute ,
Antitrust Violations ,
Biotechnology ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Hospitals ,
Medicare ,
Medicare Shared Savings Program ,
Nurses ,
OIG ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Price Transparency ,
Technology ,
Telehealth ,
TRICARE
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
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
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
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
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
9/17/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Medicare Part B ,
Medicare Part D ,
Pharmaceutical Industry ,
Prescription Drugs ,
Rulemaking Process ,
Secretary of HHS ,
Trump Administration
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
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
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
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
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
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
In this installment of the Healthcare Enforcement Quarterly Roundup we cover several topics that have persisted over the past few years and identify new issues that will shape the scope of enforcement efforts in 2020. In this...more
2/7/2020
/ Administrative Procedure Act ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Compounding ,
Drug Distribution ,
Enforcement Actions ,
Enforcement Guidance ,
False Claims Act (FCA) ,
Health Care Providers ,
Health Insurance ,
Healthcare Fraud ,
Healthcare Reform ,
Kickbacks ,
Medicare ,
Opioid ,
Overpayment ,
Pain Management ,
Pharmacies ,
Prescription Drugs ,
Private Equity ,
Regulatory Violations ,
Rulemaking Process ,
Settlement Negotiations ,
Stark Law
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
2/5/2020
/ Audits ,
Centers for Medicare & Medicaid Services (CMS) ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Fee-for-Service ,
GAO ,
HRSA ,
Managed Care Contracts ,
Medicaid ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Section 340B