Researchers at Sentinel One and Dragos have detected malicious code, called EKANS or Snake, that has been designed specifically to target industrial control systems (ICS), including those of oil refineries, manufacturing...more
2/7/2020
/ China ,
Critical Infrastructure Sectors ,
Cyber Attacks ,
Cyber Crimes ,
Cyber Threats ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Protection ,
Data Security ,
Department of Health and Human Services (HHS) ,
Drones ,
Hackers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Identity Theft ,
Infectious Diseases ,
Malware ,
Medical Records ,
OCR ,
Personally Identifiable Information ,
Point of Sale Terminals ,
Public Health ,
Retailers ,
Tax Fraud ,
Vulnerability Assessments
The HHS Office for Civil Rights (OCR) issued an Important Notice Regarding Individuals’ Right of Access to Health Records through its email list serve on January 29, 2020. In the Notice, OCR addressed the recent memorandum...more
A bipartisan bill was introduced in the U.S. House of Representatives on January 13, 2020, that (1) would allow hemp-derived cannabidiol (CBD) to be regulated as a dietary supplement, if all of the other applicable...more
1/29/2020
/ Biotechnology ,
Cannabidiol (CBD) oil ,
Cannabis Products ,
Decriminalization of Marijuana ,
Dietary Supplements ,
Direct to Consumer Sales ,
Farm Bill ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Food Supply ,
Health and Safety ,
Hemp ,
Legislative Agendas ,
Manufacturers ,
Marijuana ,
Marijuana-Infused Edibles ,
Medical Foods ,
Plant Based Products ,
Proposed Legislation ,
Regulatory Oversight ,
Retail Market ,
Retail Sales ,
USDA
On November 26, 2019, the Department of Justice (DOJ) announced a $26.67 million settlement with a laboratory testing corporation, Boston Heart Diagnostics Corporation (Boston Heart). The settlement resolves allegations of...more
12/9/2019
/ Anti-Kickback Statute ,
Billing ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Billing ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Kickbacks ,
Remuneration ,
Self-Referral ,
Settlement ,
Whistleblowers
On October 9, 2019, the Department of Health and Human Services (HHS) released its long-awaited proposals (the Proposed Rules) to update regulatory exceptions to the federal Physician Self-Referral Law (the Stark Law), the...more
The Advanced Medical Technology Association (AdvaMed) has revised its U.S. Code of Ethics for Interactions with Health Care Professionals, with updates that take effect January 1, 2020. Until then, the current AdvaMed Code...more
On July 30, 2019, the Centers for Medicare & Medicaid Services (CMS) announced “Data at the Point of Care” (DPC), a pilot program that will provide clinicians with access to claims data. The pilot program follows on the heels...more
On July 18, 2019, the Centers for Medicare & Medicaid Services (CMS) published a Final Rule establishing requirements for arbitration agreements between long-term care (LTC) facilities and their residents. The Final Rule...more
In a Memorandum Opinion, Judge Amit P. Mehta, of the U.S. District Court for the District of Columbia, vacated a U.S. Department of Health and Human Services (HHS) Final Rule, just days before its July 9 effective date. The...more
7/11/2019
/ Advertising ,
Department of Health and Human Services (HHS) ,
Direct to Consumer Sales ,
Drug Pricing ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
Pharmaceutical Industry ,
Prescription Drugs ,
Price Transparency ,
Social Security Act ,
Trump Administration ,
Vacated
In a unanimous decision issued on May 13, 2019, the U.S. Supreme Court sought to resolve lingering confusion over the statute of limitations under the False Claims Act (FCA) for qui tam suits in which the federal government...more
5/23/2019
/ Appeals ,
Cochise Consultancy Inc v United States ex rel Hunt ,
False Claims Act (FCA) ,
First-to-File ,
Government Officials ,
Intervenors ,
Oral Argument ,
Qui Tam ,
Relators ,
SCOTUS ,
Split of Authority ,
Statute of Limitations
The Centers for Medicare and Medicaid Services (CMS) announced a final rule, to be published on May 23, 2019, amending the Medicare Advantage program (Part C) and Prescription Drug Benefit program (Part D) regulations. ...more
5/20/2019
/ Amended Regulation ,
Biologics ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Electronic Prescribing ,
Final Rules ,
Medicare ,
Medicare Advantage ,
Medicare Part D ,
Out-of-Pocket Expenses ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Requirements ,
Rulemaking Process
On May 10, 2019, the Centers for Medicare and Medicaid published a Final Rule on drug pricing transparency in consumer advertisements. ...more
5/16/2019
/ Advertising ,
Biologics ,
Biopharmaceutical ,
Centers for Medicare & Medicaid Services (CMS) ,
Direct to Consumer Sales ,
Drug Pricing ,
False Advertising ,
Final Rules ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs ,
Price Transparency ,
Rulemaking Process
On April 2, 2019, the Federal Food and Drug Administration (FDA) issued a statement and announced a public hearing on consumer products derived from cannabis and its components, including cannabidiol (CBD). ...more
FIRRMA Pilot Program Puts Critical Technology in the Spotlight -
On November 10, 2018, the inter-agency Committee on Foreign Investment in the United States (CFIUS) will begin a pilot program that will implement certain...more
The Centers for Medicare and Medicaid Services (CMS) announced a Proposed Rule to amend Medicare Advantage (MA) regulations and Prescription Drug Benefit program (Part D) regulations. The Proposed Rule will be published on...more
On November 6, 2018, the Office of Inspector General (OIG) of the Department of Health and Human Services published a favorable Advisory Opinion regarding a proposed arrangement comprised of substantial donations that were...more
There has been a recent surge of lawsuits and demand letters alleging company websites are violating the Americans with Disability Act (the “ADA”). In the first six months of 2018, there were at least 1,053 lawsuits alleging...more
10/1/2018
/ Americans with Disabilities Act (ADA) ,
Disability Discrimination ,
DMCA ,
Product Labels ,
Proposition 65 ,
Public Accommodation ,
Regulatory Standards ,
Safe Harbors ,
Title III ,
Warning Labels ,
Website Accessibility ,
Website Owner Liability ,
Websites
The Office of Inspector General (OIG), Health and Human Services, issued an Advisory Opinion allowing an arrangement between a licensed offeror of Medicare Supplemental Health Insurance policies (Medigap Offeror) and a...more
On June 25, 2018, the U.S. Food and Drug Administration approved Epidiolex, an orally administered drug derived from the marijuana plant, Cannabis sativa. The drug is approved for use for patients two years and older, for the...more
On June 1, 2018, the Health Resources and Services Administration (HRSA) announced it was once again delaying the final rule that had set forth the calculation for the 340B Program ceiling price and drug manufacturer civil...more
The Office of Inspector General (OIG), Health and Human Services issued an Advisory Opinion allowing an arrangement proposed by a federally qualified health center look-alike (FQHC look-alike) to provide free technology items...more
6/5/2018
/ Advisory Opinions ,
Anti-Kickback Statute ,
Drug Pricing ,
FQHC ,
Health Care Providers ,
Medicaid ,
Medical Reimbursement ,
Medicare ,
OIG ,
Section 340B ,
State Funding ,
Telemedicine
The Office of Medicare Hearings and Appeals (OMHA) has announced the expansion of their Settlement Conference Facilitation (SCF) program. ...more
On April 2, 2018, the Centers for Medicare & Medicaid Services (CMS) issued a Final Rule, updating Medicare Advantage (MA) and the prescription drug benefit program (Part D). ...more
4/9/2018
/ Centers for Medicare & Medicaid Services (CMS) ,
Enrollment ,
Final Rules ,
Medicare ,
Medicare Advantage ,
Medicare Part D ,
Pharmacies ,
Prescription Drug Coverage ,
Prescription Drugs ,
Regulatory Oversight ,
Regulatory Standards
On March 21, 2018, the Food and Drug Administration (FDA) published two guidance documents addressing postmarketing safety reporting requirements (PMSR) for combination products. The FDA had previously issued a Final Rule on...more
This week, the U.S. Food & Drug Administration (FDA) published draft guidance, describing FDA’s policy and process for evaluating bulk drug substances used in compounding by outsourcing facilities that are registered under...more
3/28/2018
/ Draft Guidance ,
Drug Compounding ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Pharmaceutical Distribution ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Regulatory Oversight ,
Regulatory Standards ,
Section 503