The California State Senate and State Assembly passed Assembly Bill (AB) 3129 on August 31, 2024, immediately prior to the end of the state’s legislative session. The bill now heads to the desk of Governor Gavin Newsom as a...more
9/5/2024
/ Acquisitions ,
California ,
Governor Newsom ,
Health Care Providers ,
Healthcare Facilities ,
Hedge Funds ,
Legislative Agendas ,
New Legislation ,
Private Equity ,
Regulatory Agenda ,
State and Local Government ,
State Legislatures
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for February 2024. We discuss various regulatory developments, including guidance on the use of AI in coverage decisions and texting...more
3/15/2024
/ Anti-Kickback Statute ,
Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
Confidential Information ,
Department of Health and Human Services (HHS) ,
Enforcement ,
False Claims Act (FCA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Healthcare Facilities ,
Healthcare Reform ,
Hospitals ,
Machine Learning ,
Opioid ,
Patient Confidentiality Breaches ,
Substance Abuse ,
Telehealth ,
Texting
On November 28, 2023, California’s Office of Health Care Affordability (OHCA) published a notification of proposed emergency regulatory action indicating that OHCA is planning to submit the proposed regulations to the Office...more
California’s Office of Health Care Affordability (OHCA) has published draft regulations on the healthcare transaction notice requirement that will become effective on April 1, 2024. Entities entering into healthcare...more
Citing “policy and operational challenges” with the current 340B Administrative Dispute Resolution (ADR) Process, the US Department of Health and Human Services (HHS) has issued a new Proposed Rule to modify the current ADR...more
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
On September 28, 2022, the US District Court for the District of Columbia vacated the 2022 rule under which the US Department of Health and Human Services (HHS) reduced Medicare Part B payments on 340B drugs paid under the...more
10/4/2022
/ American Hospital Association ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Medicare Part B ,
Outpatient Prospective Payment System (OPPS) ,
Payment Rates ,
Permanent Injunctions ,
Proposed Rules ,
Reimbursements ,
Restoration Terms ,
SCOTUS ,
Section 340B ,
Vacated
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant enforcement activity between July 21 and August 20, 2022. Key updates include a case in which the US Court of Appeals for the Eighth Circuit...more
9/1/2022
/ Affordable Care Act ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
False Claims Act (FCA) ,
Health Care Providers ,
Hospitals ,
Inflation Reduction Act (IRA) ,
Long Term Care Facilities ,
Medicare ,
OIG ,
Payment Systems ,
Section 1557 ,
Skilled Nursing Facility
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
In this installment of the Healthcare Enforcement Roundup we cover new and longstanding issues impacting the healthcare enforcement landscape. First, we explore the impact of the Coronavirus (COVID-19) on the healthcare...more
7/27/2020
/ 1135 Waivers ,
Compliance ,
Continuing Legal Education ,
Coronavirus/COVID-19 ,
Department of Justice (DOJ) ,
e ,
False Claims Act (FCA) ,
Guidance Update ,
Health Care Providers ,
Hospitals ,
Objective Falsity ,
Physicians ,
Split of Authority ,
Stark Law ,
Whistleblowers
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
On April 28, 2020, the Centers for Medicare and Medicaid Services (CMS) issued Frequently Asked Questions for Hospitals and Critical Access Hospitals regarding EMTALA (FAQs) as a supplement to the memorandum on the Emergency...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
As the US federal government dedicates trillions of dollars toward containing and treating Coronavirus (COVID-19) and stimulating the national economy, it is also waiving many federal health program requirements to allow...more
The Centers for Medicare and Medicaid Services is expediting Medicare enrollment applications and allowing certain categories of practitioners to temporarily enroll in Medicare Part B to increase the number of healthcare...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