Health Law Gurus

Health Law Gurus

Health Law: News,
Commentary & Insights

Ads will be Required to Disclose Prices for Rx Drugs

Posted in Health Insurance, Legislation, News from the Health Law Gurus, Prescription Drugs and Medical Devices, Regulations

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 advertising. Despite the rapidly developing alternative media platforms, TV drug marketing is still thriving, as pharma companies generally target the 65-plus population that still watches live television.

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FDA Tackles the Escalating Medical Device Cybersecurity Threats

Posted in Cybersecurity, FDA, Privacy

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 actively discussing cybersecurity trends and looking at the rise of identity technologies and web intelligence.

According to the U.S. Department of Health and Human Services Office of Civil Rights, more than 170 million American health records have been exposed since 2009. Such exposures lead to data breaches, causing the healthcare industry losses exceeding $5 billion per year.

Recent hacks of hospitals and infiltrations into healthcare providers’ computer systems evidenced that healthcare organizations are largely unprepared to protect patient information against the continuously developing landscape of cyber threats.

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Tax Audit Risk for Nonprofit Hospitals is Rising

Posted in Trends

Several months ago Senate Finance Committee members Chuck Grassley, R-Iowa, and Chair Orrin G. Hatch, R-Utah, stirred the hornets’ nest again for nonprofit hospitals by asking the IRS for answers regarding its oversight of nonprofit hospitals.  This request for information is expected to lead to additional IRS scrutiny of nonprofit hospitals’ nationwide;  additional scrutiny that comes at a time when nonprofit hospitals are already scrambling to comply with the tax law changes under the 2017 Tax Cuts and Jobs Act.   Continue Reading

DOJ Signals New Direction for the False Claims Act

Posted in False Claims Act

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 relator’s/whistleblower’s objection was leaked in January, despite being labeled “Privileged and Confidential; For Internal Government Use Only” (the Granston Memo). The second memorandum, related to the use of government guidance as a basis for enforcement actions was released by the Department (the Agency Guidance Memo).  Together, the memos may demonstrate a new, more business-friendly, direction for the Department. Continue Reading

Supreme Court Punts on False Claims Act Specificity Requirement

Posted in False Claims Act

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 Court to resolve a circuit split on the question of what Fed. R. Civ. P. 9(b) means in False Claims Act (“FCA”) context. By punting on this issue once again, the Court leaves in place the current confusion, forum shopping, and potential for companies to face frivolous FCA litigation.  Continue Reading

Recap: Telemedicine and Legal Issues You Should Know

Posted in Telemedicine

Telemedicine is a rapidly growing industry that uses telecommunications to gather, store, and communicate clinical information. It is a subcategory of telehealth, which is the broader term encompassing all uses of telecommunications in the healthcare context. Telemedicine can be asynchronistic, where information is stored and then forwarded, or it can be used in real-time. Continue Reading

Security Alert: New Meltdown and Spectre Vulnerabilities Impact Computer Processors to Expose Sensitive Information

Posted in Big Data, Business Associates, Compliance Issues, Covered Entities, Cybersecurity, HIPAA, Medical Records, Privacy, Security, Technology

Security Alert: New Meltdown and Spectre Vulnerabilities Impact Computer Processors

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 Sharing and Analysis Center, a community of actors within the healthcare and public health sectors, recently announced that a new threat has emerged that could result in significant exposure to healthcare entities. Continue Reading

Medical Marijuana Dispensaries: Maintaining Business Records for Federal Income Tax Purposes, Not as Hard as it Sounds

Posted in Guest Contributor, Medical Marijuana, Trends

Generally, medical marijuana dispensaries are not allowed to deduct expenses for federal income tax purposes because buying and selling marijuana, even for medical reasons, is considered “trafficking in illegal drugs.”  Such dispensaries, however, are allowed to offset income by cost of goods sold (“COGS”) if they maintain sufficiently reliable records to allow the IRS to verify their income and expenditures.  Although public opinion has shifted more in favor of medical marijuana in recent years, industry culture persists so that business transactions are still primarily in cash and not formally recorded.  As a result, the industry as a whole continues to struggle to maintain sufficient business records for federal income tax purposes.  Continue Reading

Early New Year’s Resolution: Update Partnership and LLC Agreements to Comply with New IRS Audit Rules

Posted in Compliance Issues, Guest Contributor, Physician Practice Models, Regulations

In 2015, Congress repealed the complex and heavily criticized Tax Equity and Fiscal Responsibility Act of 1982 (“TEFRA”) partnership-level audit rules which apply to partnerships and most LLCs.  The new audit rules, which Congress adopted in place of the TEFRA rules, go into effect in less than a month (on 1/1/2018).  This change in audit rules will have a direct impact on the healthcare industry since many healthcare entities, such as physician practice groups, medical device companies, and diagnostic laboratories, are organized as partnerships or LLCs. Now is the time to update all partnership agreements and LLC operating agreements to include these new IRS audit rules.  Continue Reading

Fresh New Jersey Physical Therapy Rules for 2018

Posted in Compliance Issues, Legislation, Physical Therapy, Regulations, Trends

This past summer Governor Christie signed into law an amendment (“SB 1315”) to the New Jersey Physical Therapy Licensing Act of 1983 (“PT Licensing Act”), to be effective as of January 17, 2018.  Most importantly, SB 1315 will expand the scope of practice for Physical Therapists (each a “PT” and collectively “PTs”) and allow greater utilization of Physical Therapy Assistants (“PTAs,” or individually a “PTA”). In addition, SB1315 adds additional mandatory notice requirements for PTs and PTAs and makes other changes related to students, title protection, and the unlawful practice of physical therapy. Continue Reading