Health Law Gurus

Health Law Gurus

Health Law: News,
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Corporate Actors Held Individually Accountable in Recent False Claims Act Settlement

Posted in False Claims Act, Fraud and Abuse, Medicare, Pennsylvania, Prescription Drugs and Medical Devices, Trends

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 individuals and entities (“Med-Fast”). Under the agreement, which includes a $2.66 million payout by Med-Fast, the DOJ dropped civil charges against the corporation but will continue to pursue criminal charges against individual actors involved in the alleged conduct in violation of the Federal False Claims Act (“FCA”). Continue Reading

Hurricane Harvey, HIPAA, and Access to Health Information

Posted in Business Associates, Compliance Issues, Covered Entities, EHR, HIPAA, Privacy, Regulations, Security

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. Disasters like Hurricane Harvey impose significant challenges on healthcare providers and entities. Emergency rooms are inundated with patients seeking care or shelter. Some hospitals are forced to close and evacuate patients. Family and friends are frantically trying to obtain information to ensure their loved ones are safe. Continue Reading

Antidotes for America’s Addiction Crisis

Posted in Fraud and Abuse, OIG Fraud Alert, Prescription Drugs and Medical Devices, Trends

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. With more Americans dying each year from drug overdoses than gun violence and car crashes combined, the issue has been catapulted to the forefront of national policy. According to the Centers for Disease Control and Prevention (CDC), one of the biggest sources of opioid addiction has been the extensive use of opioid painkillers in clinical treatment. A recent report from the CDC found that enough opioids were prescribed in 2015 “for every American to be medicated around the clock for 3 weeks.” Therefore, the government and public health policy makers have looked for ways of reducing the use of opioids in clinical care to diminish increases in addiction. Continue Reading

The Doctor Is In – or Better Be, to Satisfy PA’s New Informed Consent Requirements

Posted in Compliance Issues, Medical Records, News from the Health Law Gurus, Pennsylvania, Physician Practice Models

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 medications, procedures, and treatment plans. Physicians, in turn, lean heavily on qualified staff members to ensure patients have access to adequate information and to foster the provision of high quality and cost-effective care. However, a ruling by the Supreme Court of Pennsylvania last week has greatly altered the practice of obtaining informed consent in Pennsylvania. As of June 20, 2017, physicians are now required to personally obtain informed consent from patients and to answer patients’ questions themselves. Continue Reading

Anchors Away! Physical Therapists Rejoice (and Book a Tropical Getaway) as CMS Extends Locum Tenens Arrangements

Posted in Legislation, Medicare, News from the Health Law Gurus, Regulations, Trends

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 providers need to complete continuing medical education requirements or take time off for vacations or medical or maternity leave. Continue Reading

Organizations Want to Cry After WannaCry Ransomware Attacks

Posted in Cybersecurity, HIPAA, HITECH, Privacy, Security, Trends

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, encrypting the user’s files and demanding payment of $300-$600 in bitcoin to unfreeze files. Hundreds of hospitals and health clinics in the British National Health Service were infiltrated by the WannaCry ransomware. As a result, the National Health Service was required to reroute patients and reschedule surgeries and appointments while its files were encrypted. As evidenced by the WannaCry attack and the increasing frequency of ransomware attacks, particularly ransomware attacks targeting hospitals, health care entities need to be vigilant regarding the secure storage of patient information, and proactive to ensure patient continuity of care in case of a ransomware attack. Continue Reading

Securing ePHI in a Mobile Health World

Posted in HIPAA, Privacy, Security, Technology, Telemedicine

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. Through the use of mobile devices, patients and providers can access real-time information that can lead to better health outcomes through improving medication compliance and understanding of treatment instructions, increasing access to care through telehealth and remote care functionalities, and enhancing the quality of physician-patient interactions. Additionally, the ability to collect and track data regarding health outcomes and deviations has enormous benefits for population health research. However, the proliferation of mobile devices in the healthcare space can create issues under the Health Information Portability and Accountability Act (HIPAA). Mobile devices can lead to patient privacy issues and can raise numerous concerns over whether covered entities have sufficient safeguards in place to secure patient protected health information (PHI). Continue Reading

BEWARE OF THE MAN-IN-THE-MIDDLE: Malicious Eavesdroppers on the Internet

Posted in Compliance Issues, Cybersecurity, Privacy, Security, Technology

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 party, Evan Eavesdropper, who publishes the PHI on the internet.  Evan Eavesdropper also decides to alter the PHI in the email before sending the email on to the clinic.  When the clinic receives the email with the altered PHI, the clinic thinks that Patty Patient is not a good candidate for its treatment program and emails its conclusions back to Dr. Primary.  Evan Eavesdropper gleefully changes this email and accepts Patty Patient into the clinic’s treatment program.  Patty Patient arrives at the clinic and finds there is no place for her in the treatment program. Continue Reading

Medical Marijuana Act Clouds the Rights of Employers to Establish and Enforce Marijuana Policies

Posted in Medical Marijuana

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 to medical marijuana through a safe and effective delivery method, is intended to balance patient need for access with patient safety. However, balancing these interests is not always an easy task, especially because marijuana remains an illegal substance under the Federal Controlled Substances Act. The attempt to balance patient access and safety, and the juxtaposition between state and federal law, can put employers in a sticky situation, particularly when it comes to establishing and enforcing zero tolerance drug policies. Continue Reading

CMS Grants Eleventh Hour Extension for Attesting to Meaningful Use

Posted in EHR, Meaningful Use

Doctor using digital tablet on gray background

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 Medicare & Medicaid Services has extended the reporting deadline until March 13, 2017, at 11:59 p.m. ET. This extension is intended to allow providers additional time to attest to the 2016 program requirements and avoid a 2018 payment adjustment. Continue Reading