This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for July 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including a final rule on provider...more
9/6/2024
/ Advisory Opinions ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
False Claims Act (FCA) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Information Blocking Rules ,
Medicare ,
OIG ,
Proposed Regulation ,
Regulatory Agenda ,
Telehealth
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the Calendar Year (CY) 2025...more
5/29/2024
/ Advisory Opinions ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Dispute Resolution ,
Enforcement ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Laboratory Developed Tests ,
Medical Devices ,
Medicare Advantage ,
Medicare Fraud ,
Medicare Part D ,
Non-Compete Agreements ,
Nursing Homes ,
OCR ,
OIG ,
Popular ,
Privacy Laws ,
Regulatory Agenda ,
Reproductive Healthcare Issues ,
Sentencing ,
Settlement ,
Telemedicine
On April 18, 2024, the US Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) issued the long-awaited 340B Administrative Dispute Resolution (ADR) Final Rule. The final rule...more
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
1/15/2024
/ Ambulatory Surgery Centers ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Disclosure Requirements ,
Enforcement Actions ,
False Claims Act (FCA) ,
Final Rules ,
Fraud and Abuse ,
Healthcare Facilities ,
Healthcare Fraud ,
Healthcare Reform ,
Hospitals ,
No Surprises Act (NSA) ,
Outpatient Prospective Payment System (OPPS) ,
Payment Systems ,
Regulatory Reform ,
Skilled Nursing Facility
This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more
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
11/6/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Final Rules ,
Healthcare ,
Healthcare Facilities ,
Healthcare Reform ,
Hospitals ,
Medical Reimbursement ,
Outpatient Prospective Payment System (OPPS) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Section 340B
On February 18, 2023, the Centers for Medicare and Medicaid Services (CMS) extended the timeline for publishing the Medicare Secondary Payer and Certain Civil Monetary Penalties final rule by one additional year, stating that...more
In December 2022, the Center for Medicare and Medicaid Services (CMS) unexpectedly issued a proposed rule that would materially change the obligations of entities participating in the Medicare program to report and return...more
Rural emergency hospitals (REHs) are a new provider type that will allow Medicare to pay for emergency department and other outpatient hospital services in rural areas beginning on January 1, 2023, without requiring the...more
11/29/2022
/ Centers for Medicare & Medicaid Services (CMS) ,
Emergency Rooms ,
Final Rules ,
Health Care Providers ,
Hospitals ,
Medicare ,
Outpatient Services ,
Provider Payments ,
Rural Areas ,
Rural Health Care Providers ,
Stark Law
Consistent with the US Supreme Court’s ruling in AHA v. Becerra and its statements in the 2023 Outpatient Prospective Payment System (OPPS) Proposed Rule, the Centers for Medicare & Medicaid Services (CMS) has finalized its...more
11/8/2022
/ American Hospital Association et al v Becerra Secretary Of Health And Human Services et al ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Final Rules ,
MedPAC ,
Outpatient Prospective Payment System (OPPS) ,
Payment Systems ,
Physician Fee Schedule ,
SCOTUS ,
Section 340B
In December 2021, the US Centers for Medicare and Medicaid Services (CMS) issued the second part of its FY 2022 Inpatient Prospective Payment System (IPPS) Final Rule with Comment Period. Among other policies, the Final Rule...more
1/10/2022
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Consolidated Appropriations Act (CAA) ,
Deadlines ,
Final Rules ,
FTEs ,
Graduate Medical Education ,
Health Care Providers ,
Inpatient Prospective Payment System (IPPS) ,
Medical School ,
Residency Requirements ,
Rural Areas ,
Rural Health Care Providers
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 November 20, 2020, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a final rule as part of ongoing administration drug pricing reform efforts and in conjunction with the...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
On November 15, the Trump Administration released a final rule requiring hospitals to publicly disclose hospital charges, including negotiated prices with third-party payers by January 1, 2021. We outline key considerations...more
On September 10, 2019, the US Department of Health and Human Services Centers for Medicare & Medicaid Services (CMS) published a final rule (Final Rule) expanding Medicare, Medicaid and Children’s Health Insurance Program...more
10/1/2019
/ Affiliates ,
Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Comment Period ,
Disclosure Requirements ,
Document Retention Policies ,
Enrollment ,
Final Rules ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Medicaid ,
Medicare ,
Opt-Outs ,
Physicians ,
Public Comment ,
Reporting Requirements
President Trump has issued an Executive Order instructing several federal agencies to begin rulemaking processes intended to increase the transparency of hospital pricing. Among other measures, the Executive Order directs the...more
6/28/2019
/ Administrative Procedure Act ,
Affordable Care Act ,
American Hospital Association ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Executive Orders ,
Federal Trade Commission (FTC) ,
Final Rules ,
Healthcare Costs ,
New Legislation ,
Price Transparency ,
Rulemaking Process ,
Secretary of HHS ,
Trump Administration
The US Department of Health and Human Services and the Health Resources and Services Administration recently issued final rules related to the 340B Drug Pricing Program that impose fines on drug manufacturers that overcharge...more
The Centers for Medicare & Medicaid Services released the calendar year 2017 final rule implementing changes to the Medicare hospital Outpatient Prospective Payment System, or OPPS, including provisions implementing Section...more
On December 30, 2015, the Centers for Medicare & Medicaid Services (CMS) published its final rule establishing a prior authorization program for certain durable medical equipment, prosthetics, orthotics and supplies (DMEPOS)...more
On October 30, 2015, the Centers for Medicare & Medicaid Services (CMS) released its final rule updating the Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System for...more
On July 23, 2013, the U.S. Department of Health and Human Services Health Resources and Services Administration (HRSA) issued a long-anticipated Final Rule regarding the 340B Drug Pricing Program (340B Program) orphan drug...more