On July 31, 2024, the Centers for Medicare & Medicaid Services (“CMS”) issued its proposed rule (“Proposed Rule”) for the 2025 Medicare Physician Fee Schedule, which includes implications for telehealth services reimbursable...more
As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more
1/26/2024
/ Acquisitions ,
Amgen v Sanofi ,
Antitrust Division ,
Artificial Intelligence ,
Biden Administration ,
Biosimilars ,
Chevron Deference ,
Clawbacks ,
Clinical Trials ,
Compensation ,
Compliance ,
Corporate Integrity Agreement ,
Criminal Prosecution ,
Data Preservation ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Pricing ,
Enforcement ,
EU ,
Executive Orders ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Investigations ,
Life Sciences ,
Mergers ,
Mobile Devices ,
OPDP ,
Pharmaceutical Industry ,
Pilot Programs ,
Privacy Laws ,
Proposed Rules ,
Risk Management ,
Section 340B ,
Self-Disclosure Requirements ,
Voluntary Disclosure
On April 27, 2021, the Centers for Medicare and Medicaid Services (“CMS”) released the Hospital Inpatient Prospective Payment System (“IPPS”) and Long-Term Care Hospital (“LTCH”) unpublished Proposed Rule for 2022 (“Proposed...more
As mentioned in our November 25, 2000 Healthcare Law Blog article, “Big Changes for Health Care Fraud and Abuse: HHS Gifts Providers Updates to the Stark Law and the AKS, Just in Time for the Holidays,” the Centers for...more
On November 20, 2020, the Centers for Medicare and Medicaid Services (“CMS”) and the Office of Inspector General (“OIG”) promulgated much-anticipated and significant final rules intended to “modernize” and “clarify”...more
11/30/2020
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Cybersecurity ,
Electronic Medical Records ,
Exceptions ,
Health Care Providers ,
New Guidance ,
OIG ,
Physicians ,
Proposed Rules ,
Safe Harbors ,
Stark Law ,
Value-Based Care
As part of HHS’ Regulatory Sprint to Coordinated Care, CMS recently published a proposed rule that, if finalized, would fundamentally change and alleviate the manner in which the Stark Law regulatory framework has...more
On October 9, 2019, the Department of Health and Human Services (“HHS”) Centers for Medicare and Medicaid Services (“CMS”) and Office of Inspector General (“OIG”) released proposed rules in conjunction with HHS’ “Regulatory...more
10/11/2019
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
OIG ,
Physicians ,
Proposed Rules ,
Regulatory Requirements ,
Safe Harbors ,
Stark Law ,
Value-Based Care
On July 29, 2019, CMS released its proposed outpatient prospective payment system (“OPPS”) rule outlining a variety of changes it may implement for calendar year 2020. One proposal that has inspired immediate reactions from...more
8/6/2019
/ American Hospital Association ,
Anti-Competitive ,
Comment Period ,
Disclosure Requirements ,
Health Care Providers ,
Hospitals ,
Medicare ,
Outpatient Prospective Payment System (OPPS) ,
Price Transparency ,
Proposed Rules ,
Public Comment
The U.S. Department of Defense (“DOD”) claims that fraud and abuse is inhibiting the ability of the Defense Health Agency (“DHA”), the agency responsible for administering TRICARE, to support and deliver “integrated,...more
5/6/2019
/ Civil Monetary Penalty ,
Comment Period ,
Criminal Investigations ,
Department of Defense (DOD) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Fraud and Abuse ,
Government Agencies ,
Health Care Providers ,
Medicaid ,
Medicare ,
Military Service Members ,
Proposed Regulation ,
Proposed Rules ,
Public Comment ,
TRICARE