As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
4/1/2025
/ Department of Health and Human Services (HHS) ,
Diagnostic Tests ,
Electronic Protected Health Information (ePHI) ,
Food and Drug Administration (FDA) ,
Government Shutdown ,
Life Sciences ,
Medical Devices ,
New Regulations ,
Pharmaceutical Industry ,
Proposed Rules ,
Regulatory Requirements ,
Tariffs ,
Trump Administration ,
US Trade Policies
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape....more
10/1/2024
/ Biden Administration ,
Biologics ,
Clinical Trials ,
Department of Health and Human Services (HHS) ,
Diversity ,
Draft Guidance ,
EU ,
European Medicines Agency (EMA) ,
Executive Orders ,
Final Rules ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Information Reports ,
Laboratory Developed Tests ,
Life Sciences ,
Med Tech ,
Medical Research ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
New Guidance ,
OCR ,
Pediatrics ,
Pending Legislation ,
Personal Data ,
Pharmaceutical Industry ,
Scientific Research ,
UK
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. ...more
7/2/2024
/ Biologics ,
Clinical Trials ,
Congressional Committees ,
Diversity ,
Draft Guidance ,
EU ,
European Commission ,
Final Rules ,
Food and Drug Administration (FDA) ,
Laboratory Developed Tests ,
Life Sciences ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Patient Privacy Rights ,
Pediatrics ,
Pharmaceutical Industry ,
PHI ,
Prescription Drugs ,
Proposed Legislation
On November 6, 2023, for the first time in 15 years, HHS OIG issued a new reference guide for the health care compliance community – the General Compliance Program Guidance, or GCPG. While the GCPG does not set new legal...more
11/27/2023
/ Anti-Kickback Statute ,
Board of Directors ,
Compliance ,
Department of Health and Human Services (HHS) ,
Employee Training ,
False Claims Act (FCA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Life Sciences ,
New Guidance ,
OIG ,
Policies and Procedures ,
Stark Law ,
Voluntary Correction Program ,
Voluntary Participation
Two recent federal court cases signal new significant developments with respect to the 340B Drug Pricing Program. Specifically: (1) new federal district court litigation challenging a recent HRSA Notice involving 340B Program...more
In October 2021, we reported on an uptick in the passage of state drug price transparency legislation. As an update to that report, as of October 2023, approximately 22 states have now passed drug price transparency laws...more
On October 30, 2023, President Biden issued an Executive Order (EO) on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence. The EO establishes sweeping directives and priorities for federal...more
11/1/2023
/ Artificial Intelligence ,
Biden Administration ,
Civil Rights Act ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Federal Procurement Systems ,
Intellectual Property Protection ,
Legislative Agendas ,
National Security ,
NIST ,
Popular ,
Proposed Legislation ,
Public Agencies ,
Regulatory Agenda ,
Semiconductors ,
Technology Sector
On September 29, 2023, the U.S. District Court for the District of Columbia vacated a Trump-era rule from 2021 that allowed insurers to exclude drug manufacturer co-pay support coupons and assistance from a patient’s annual...more
As the life sciences industry continues to expand and grow increasingly complex, so does its legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging laws and...more
6/30/2023
/ Biologics ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Life Sciences ,
Marketing ,
Marketing Authorization Application ,
Med Tech ,
Medicaid ,
Medical Devices ,
Medicare ,
Pharmaceutical Industry ,
PHI ,
Prescription Drugs
On March 15, 2023, the Centers for Medicare & Medicaid Services (CMS) issued an initial guidance memorandum on the Medicare Drug Price Negotiation Program (Negotiation Program) created by the Inflation Reduction Act of 2022...more
On February 14, 2023, the U.S. Department of Health and Human Services (HHS) published a report identifying three models that the Center for Medicare & Medicaid Services’ (CMS) Center for Medicare & Medicaid Innovation (CMMI)...more
On February 9, 2023, the Centers for Medicare & Medicaid Services (CMS) released initial program guidance addressing the inflation rebate provisions of the Inflation Reduction Act of 2022 (IRA). These provisions apply to how...more
2/24/2023
/ Biologics ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Inflation Adjustments ,
Inflation Reduction Act (IRA) ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
OIG ,
Prescription Drugs ,
Proposed Guidance ,
Rebates ,
Section 340B
On February 9, 2023, the Centers for Medicare & Medicaid Services (CMS) released initial program guidance on the inflation rebate provisions of the Inflation Reduction Act of 2022 (IRA). These provisions apply to how Medicare...more
The 340B Drug Pricing Program is a government program, administered by the Health Resources and Services Administration (HRSA), that allows qualifying hospitals and clinics that treat low-income and uninsured patients to buy...more
On January 30, 2023, the Court of Appeals for the Third Circuit issued a precedential decision rejecting a policy of the Department of Health and Human Services (HHS) in implementing the 340B Program. Under that policy, HHS...more
The Inflation Reduction Act’s (“IRA”) drug price negotiation provisions have captured the pharmaceutical and biotech industry’s attention. In part, the IRA allows the Centers for Medicare & Medicaid Services (“CMS”) to...more
1/27/2023
/ Biologics ,
Biotechnology ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Drug Pricing ,
Inflation Reduction Act (IRA) ,
Medicare Part B ,
Medicare Part D ,
Negotiations ,
OMB ,
Prescription Drugs ,
Public Comment
On August 7, 2022, the U.S. Senate passed the Inflation Reduction Act of 2022, which includes some of the most significant drug pricing-related changes since the passage of the Medicare Prescription Drug Improvement...more
8/10/2022
/ Civil Monetary Penalty ,
Drug Pricing ,
Enforcement ,
Food and Drug Administration (FDA) ,
Medicaid ,
Medicaid Drug Rebate Program ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
Pending Legislation ,
Pharmaceutical Industry ,
Prescription Drugs ,
Rebates ,
Secretary of HHS
Litigation involving drug price reporting under the Medicaid Drug Rebate Program (MDRP) has been very active in 2022. Most recently, on August 3, 2022, an Illinois federal jury levied a $61 million verdict against Eli...more
8/5/2022
/ Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Funding ,
Medicaid ,
Medicaid Drug Rebate Program ,
Pharmaceutical Industry ,
Prescription Drugs ,
Reporting Requirements ,
Section 340B
The U.S. Department of Justice (“DOJ”) recently announced that over $5.6 billion in False Claims Act (“FCA”) settlements and judgments had been reached during the 2021 fiscal year, with over $5 billion of those settlements...more
3/8/2022
/ Anti-Kickback Statute ,
Clinical Laboratories ,
Department of Justice (DOJ) ,
Digital Health ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Health Technology ,
Healthcare Fraud ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Private Equity ,
Telehealth
On January 11, 2022, the Centers for Medicare and Medicaid Services (CMS) released a proposed National Coverage Determination (NCD) decision memo limiting Medicare coverage for Biogen’s new Alzheimer’s drug, Aduhelm. Under...more
After several years without any enforcement, the U.S. Department of Justice (“DOJ”) recently penalized medical device and life sciences companies for violating the U.S. Provider Payments Sunshine Act (“Sunshine Act”) (42...more
11/5/2021
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Justice (DOJ) ,
Failure to Report ,
False Claims Act (FCA) ,
Health Care Providers ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Physician-Owned Distributors ,
Physicians ,
Settlement Agreements ,
Sunshine Act
In 2016, states began passing pharmaceutical price reporting laws. These laws are designed to bring transparency to a pharmaceutical manufacturer’s drug pricing process by requiring drug manufacturers to report pricing and...more
In 2016, states began passing pharmaceutical price reporting laws. These laws are designed to bring transparency to a pharmaceutical manufacturer’s drug pricing process by requiring drug manufacturers to report pricing and...more
The Centers for Medicare & Medicaid Services (CMS) released its proposed 2022 Physician Fee Schedule rule (Proposed Rule) on July 13, 2021. Included in the rule are several proposed updates to the CMS Open Payments Program,...more
7/28/2021
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Delays ,
Health Care Providers ,
Open Payments ,
Ownership Interest ,
Physician Fee Schedule ,
Physician-Owned Distributors ,
Physicians ,
Proposed Rules ,
Public Comment ,
Short-Term Loans ,
Sunshine Act ,
Teaching Hospitals