During the COVID-19 Public Health Emergency, the Centers for Medicare and Medicaid Services (the “CMS”) relaxed some rules to expand access to telehealth, including through audio-only communication platforms. With the...more
From the very outset of the COVID-19 pandemic the development of an effective and safe vaccine for COVID-19 became a public and private priority pursed with urgency and intensity. Towards that end, the United States...more
As the national COVID-19 Public Health Emergency persists, uncertainty regarding our families’ and our own health and safety continues to grow. With several businesses forced to close their doors and layoff employees due to...more
As Pennsylvania experiences its first cases of COVID-19 (a novel form of Coronavirus), with fourteen presumptive cases at the time of this writing, the Commonwealth is taking all necessary actions to combat the spread of the...more
Change may be coming soon to Pennsylvania’s medical malpractice venue rule (Rule 1006(a.1)) - a change that could send medical malpractice filings in Philadelphia skyrocketing. Last week, the Legislative Budget and Finance...more
The U.S. Supreme Court has just issued a unanimous decision in the case Cochise Consultancy Inc. et al. v. U.S. ex. rel Hunt (decided on May 13, 2019), that qui tam whistleblowers can invoke the ‘”government knowledge”...more
5/17/2019
/ Appeals ,
Cause of Action Accrual ,
Cochise Consultancy Inc v United States ex rel Hunt ,
Dismissals ,
False Claims Act (FCA) ,
Federal Contractors ,
Intervenors ,
Limitation Periods ,
Qui Tam ,
Reaffirmation ,
Relators ,
Reversal ,
SCOTUS ,
Statute of Limitations
Summing up the results of the previous year, regulatory experts have noted that more than half of the businesses punished for HIPAA lapses in 2018 involved well-known big business entities making it a notable theme of the...more
1/18/2019
/ Data-Sharing ,
Department of Health and Human Services (HHS) ,
Enforcement ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
NIST ,
OCR ,
Patient Privacy Rights ,
PHI ,
Proposed Amendments ,
Public Comment ,
Request For Information
The Trump administration has issued a 119-page report Reforming America’s Healthcare System Through Choice and Competition that reaffirms the administration’s effort to deregulate the healthcare industry in an attempt to...more
Ever since the FDA approved advertisements for prescription drugs on television, pharmaceutical companies have been heavily relying on them and collectively represent the third highest spender of any industry in national TV...more
11/1/2018
/ Advertising ,
Centers for Medicare & Medicaid Services (CMS) ,
Commercial Speech ,
Constitutional Challenges ,
Department of Health and Human Services (HHS) ,
Disclosure Requirements ,
Drug Pricing ,
First Amendment ,
Food and Drug Administration (FDA) ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Rules ,
Television Commercials
Cybersecurity and data breaches have been in public spotlight in the past several years as a result of recurring cyber-attacks on numerous organizations, business, its customers and communities in general. Media have been...more
Early this year, two memoranda issued by the United States Department of Justice (the Department) were made public. The first, outlining the Department’s new stance on dismissing a False Claims Act (FCA) case over a...more
Last week the Supreme Court of the United States rejected a petition for a writ of certiorari in Medical Device Business Services, Inc. et al. v. United States ex rel. Nagrol et al. In this case, the petitioner asked the...more
Last spring the WannaCry ransomware cyber-attack crippled the global economy, impacting over 100,000 organizations throughout 150 countries and generating an estimated $4 billion in losses. The National Health Information...more
The Pennsylvania legislature is currently considering legislation that would amend the Pennsylvania Mental Health Procedures Act (the “Act”) to provide for court-ordered outpatient treatment for those suffering from mental...more
The Department of Justice (“DOJ”) has sent a clear message that individuals cannot hide behind the corporate shield in its recent settlement with Med-Fast Pharmacy, Inc. and the charges brought against its associated...more
Hurricane Harvey has been pummeling the Gulf Coast since Monday, with nearly 52 inches of rainfall in parts of Texas. The storm has displaced thousands of people from their homes and has resulted in over 30 reported deaths....more
Opioid addiction and abuse has exploded into a national epidemic. Every three weeks, America faces a death toll equivalent to the September 11th attacks due to drug overdoses, 75 percent of which are from opioid use. ...more
With the increased presence of qualified staff members in a physician’s office and the constant time-pressure on physicians, many patients rely heavily on individuals other than the physician to answer questions about...more
Even doctors get sick sometimes, or need to take a vacation, and when they do, patients are not seen and billing does not happen. Cue locum tenens – a system used by providers to ensure continuity of care and revenue when...more
Earlier this month a massive ransomware attack spread throughout 150 countries, infecting 300,000 computers and crippling businesses across the globe. The ransomware, called “Wannacry,” infiltrated a variety of institutions,...more
Could a lost cell phone or laptop cost your organization millions of dollars?
Mobile devices have enabled vast improvements in the efficiency and quality of healthcare delivery. ...more
Imagine this: Dr. Primary is treating Patty Patient for substance abuse and emails Patty Patient’s protected health information (PHI) to a treatment clinic. Before the email arrives at the clinic, it is intercepted by a third...more
Pennsylvania’s recently passed Medical Marijuana Act (MMA) has left employers dazed and confused about whether they may continue to enforce zero tolerance drug policies. The MMA, which provides qualifying patients with access...more
Providers participating in the Medicare Electronic Health Record (EHR) Incentive Program now have an additional thirteen days to register and attest to meeting the meaningful use requirements for 2016. The Centers for...more
The failure to timely report a breach of unsecured protected health information (PHI) has cost Presence Health (one of the largest health systems in Illinois) almost half of a million dollars.
Earlier this month,...more