On May 1, 2020, Blue Bell Creameries L.P. (Blue Bell) agreed to plead guilty to charges that it distributed contaminated ice cream products that were linked to a 2015 listeriosis outbreak. The Blue Bell outbreak made...more
5/12/2020
/ Blue Bell Creameries ,
Corporate Counsel ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food Contamination ,
Food Manufacturers ,
Food Safety ,
Listeria ,
Settlement Agreements
On August 22, the Substance Abuse and Mental Health Services Administration (“SAMHSA”) announced a new proposed rule (the “Proposed Rule”) amending 42 CFR part 2 (“Part 2”), which is aimed at protecting patient records...more
9/4/2019
/ Confidential Information ,
Consent ,
Disclosure Requirements ,
Health Care Providers ,
HIPAA Privacy Rule ,
Information Sharing ,
Medical Records ,
Opioid ,
Patient Privacy Rights ,
Pharmaceutical Industry ,
Proposed Rules ,
SAMHSA ,
Substance Abuse
Last week, President Trump signed an “Executive Order on Improving Price and Quality Transparency in American Healthcare to Put Patients First.” The order, which “seeks to enhance the ability of patients to choose the...more
7/3/2019
/ Executive Orders ,
Health Savings Accounts ,
Healthcare ,
Healthcare Reform ,
Medicare ,
Price Transparency ,
Proposed Regulation ,
Rulemaking Process ,
Secretary of HHS ,
Transparency ,
Trump Administration
Last week, a U.S. district court judge in the Southern District of Florida upheld a magistrate judge’s decision to dismiss False Claims Act (FCA) allegations against a compounding pharmacy, its private equity firm owner, and...more
The Department of Justice (DOJ) recently announced a $1.99 million False Claims Act (FCA) settlement with GenomeDx Biosciences Corp. (“GenomeDx”), a laboratory headquartered in Vancouver, British Columbia with operations in...more
2/22/2019
/ Department of Justice (DOJ) ,
Failure to Comply ,
False Claims Act (FCA) ,
Health Care Providers ,
Local Coverage Determination (LCD) ,
Medical Necessity ,
Medicare ,
Physician Medicare Reimbursements ,
Physicians ,
Qui Tam ,
Relators
In an Advisory Opinion posted earlier this week, the OIG gave the green light to a charitable pediatric clinic’s routine waiver of patient cost-sharing amounts. The OIG’s analysis hinged on several factors that, taken...more
1/21/2019
/ Advisory Opinions ,
Anti-Kickback Statute ,
Cost-Sharing ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Clinics ,
Healthcare Facilities ,
Low-Income Issues ,
Medicare ,
OIG ,
Pediatrics ,
Waivers
As the year draws to a close, it’s clear that 2018 was another record year for private equity investment in health care. In its report on the top health industry issues of 2019, PWC’s Healthcare Research Institute recently...more
The Massachusetts Health Policy Commission (“HPC”) held its annual Health Care Cost Trends Hearing on October 16-17, 2018. The hearing covered a wide range of topics affecting the health care industry here in the Commonwealth...more
10/25/2018
/ Electronic Medical Records ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Costs ,
Mental Health ,
Opioid ,
Popular ,
Prescription Drugs ,
Telemedicine ,
Transparency
The final bipartisan opioid package, which passed in the Senate this week and is expected to be signed into law, includes a significant revision from the original House bill that could lead to an increase in treatment options...more
The Children’s Health Insurance Program (“CHIP”), created in 1997, helps states provide health care coverage to low-income children up to age 19 whose families fall above the Medicaid eligibility threshold but are unable to...more
The Centers for Medicare & Medicaid Services (CMS) recently released its final rule overhauling long-term care (LTC) facility participation requirements for Medicare and Medicaid (“Final Rule”). This much anticipated rule...more
10/10/2016
/ Affordable Care Act ,
Arbitration Agreements ,
Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Ethics ,
Final Rules ,
Long Term Care Facilities ,
Medicaid ,
Medicare ,
Pharmacies ,
Physicians