In New Jersey, Dentists Can Now Play a Frontline Role in Screening for Diabetes

DID YOU KNOW that a trip to your dentist may include a diabetes screening?

With 37.1 percent of the state’s adult population (2,483,000 adults) believed to be pre-diabetic (with most not know­ing it), some dentists in New Jersey are now playing a frontline role in ensuring that their at-risk patients get referred to their physician for a definite diagno­sis to receive proper care.

Researchers determined that persons with diabetes are statistically more prone to gum disease—and people with periodontal issues are more likely to have or develop diabetes. At Delta Dental’s request, diabetes chairside A1c blood testing was recognized as being within the scope of dental practice by the New Jersey State Board of Dentistry.

In 2018, also related to a Delta Dental request, the American Dental Association created a new dental procedure code for a chairside A1c test; a simple finger prick blood test can determine patients’ average blood sugar levels over the last three months.

Allowing dentists to conduct this test­ing allows for earlier detection, better treatment outcomes, and the potential to help offset the $9.2 billion it costs to treat diagnosed diabetes in New Jersey.

Oral health is a crucial determinant of a patient’s overall health. With Delta Dental of New Jersey now offering cov­erage of A1c testing for most of their members, dentists are well positioned to support earlier recognition of diabetes and to refer their patients to their physi­cian earlier in the disease process.

Protecting Your Small Business from Account Fraud and Ransomware

CRIMINALS USE spoofed e-mails, malicious software spread through infected attachments and online social networks to obtain login credentials to businesses’ accounts, transfer funds from the accounts and steal private information—a fraud referred to as “corporate account takeover.”

Combating account takeover is a shared responsibility between business- es and financial institutions. Bankers can explain the safeguards small businesses need and the numerous programs avail­able that help ensure fund transfers, payroll requests and withdrawals are legitimate, accurate and authorized. Companies should train employees about safe Internet use and the warning signs of this fraud, because they are the first line of defense. These tips can help to prevent account takeover.

Protect your online environment. It is important to protect your cyber environment just as you would your cash and physical location. Do not use unprotected Internet connections. Encrypt sensitive data and keep updat-ed virus protections on your computer. Use complex passwords and change them periodically.

Partner with your bank to prevent unauthorized transactions. Talk to your banker about programs that safeguard you from unauthorized transactions. Positive Pay and other services offer call backs, device authentication, multi-person approval processes and batch limits, which help protect you from fraud.

Pay attention to suspicious activity and react quickly. Look out for unex­plained account or network activity, pop-ups, and suspicious e-mails. If detected, immediately contact your financial institution, stop all online activ­ity and remove any systems that may have been compromised. Keep records of what happened.

Understand your responsibilities and liabilities. The account agreement with your bank will detail what commercially reasonable security measures are required in your business. It is critical that you understand and implement the security safeguards in the agreement. If you don’t, you could be liable for losses resulting from a takeover. Talk to your banker if you have any questions about your responsibilities.

Beware of ransomware. Individuals and businesses have become targets to a growing online fraud scheme known as ransomware. Ransomware is a form of malware used by cybercrimi­nals to freeze your computer or mobile device, steal your data and demand a “ransom”—typically anywhere from a couple of hundred to thousands of dollars—be paid.

Ransomware poses great risks to indi­vidual computers or laptops, enterprise networks and or servers used by govern­ment agencies, financial institutions and healthcare providers. In addition to edu­cating your employees, here are some tips for your business.

Manage the use of privileged accounts. Restrict users’ ability to install and run software applications on net­work devices, in an effort to limit your networks exposure to malware.

Employ a data backup and recovery plan for all critical information. Backups are essential for lessening the impact of potential malware threats. Store the data in a separate device or offline in order to access it in the event of a ran­somware attack.

Make sure all business devices are up to date. Ensure antivirus and anti-malware solutions are set to automati­cally update and conduct regular scans so that your operating systems operate efficiently.

Contact your local FBI field office immediately to report a ransomware event and request assistance.

The Ghost of CBD Past, Present, and Future: The Future of CBD and Industrial Hemp

The new year is right around the corner, which will prove to be a truly new year for the industrial hemp industry and the crown jewel of hemp-derived consumer products: CBD.  As we have laid out in our previous two posts that you can read here and here, the already ubiquitous CBD has experienced tremendous growth in recent years.  Now that CBD has officially been de-scheduled from the controlled substances list, several barriers have been lifted pertaining to the product’s use, production, and research.  For instance, the recent legislation removed any remaining doubt that possessing and using CBD is no longer illegal under federal law.  But what about growing, transporting, and selling it?  And what is in store for the industry in the upcoming year?

As we previously mentioned, the recent Agricultural Improvement Act of 2018 (the “Farm Bill”) that was signed into law on December 20, 2018, de-scheduled CBD as a controlled substance and provides that primary oversight of the growth, production, research, and cultivation of hemp derivatives belongs to the individual states, U.S. Department of Agriculture (“USDA”), and the Food and Drug Administration (“FDA”).  Because the law was only recently passed and state and federal regulations need to be promulgated or amended, there are many unknowns about the nuances of how producers and purveyors of CBD can ensure they will be compliant.

New Jersey recently passed its own hemp pilot program requiring the state Department of Agriculture to promulgate regulations to govern the cultivation, research, testing, and sale of industrial hemp.  The Department of Agriculture, however, has yet to publish these rules.  Companies desirous of producing and selling CBD in New Jersey will need careful guidance to ensure compliance with these regulations once they are published.

Against this backdrop, businesses should tread carefully.  The consequences of non-compliance with the Farm Bill can be severe, up to and including a five-year ban on the production of industrial hemp for a third violation.  States also have the ability to refer matters to their respective Attorneys General if it is concluded that a producer acted with a higher level of culpability than simple negligence.

Beyond the statutory consequences of non-compliance, there are also other legal issues that CBD producers should be cognizant of.  For example, the FDA has historically taken a strong approach by issuing cease and desist letters to CBD producers and sellers that make bold, unverified claims about the efficacy of their products.  Since CBD research and development is in its formative stages, the FDA has not issued particular oversight as to what can and cannot be said about the efficacy of the product, though these waters will surely be tested.

The FDA, for its part, appears keenly aware that the Farm Bill may require it to alter its approach to CBD moving forward.  The agency recently issued a press release that states that “Although [cannabis-derived compounds added to food or dietary supplement] are generally prohibited to be introduced in interstate commerce, the FDA has the authority to issue a regulation allowing the use of a pharmaceutical ingredient in a food or dietary supplement.  We are taking new steps to evaluate whether we should pursue such a process.”   The press release also states that the FDA intends to hold a public meeting on such issues in the near future.  Much more to come on this front in the coming weeks and months.

In addition to getting into hot water at the federal level, states like New Jersey with strong consumer protection laws may be able to pursue claims against CBD producers and sellers for making false claims about their product in order to induce consumers to purchase the product.  Such producers could be exposed to civil liability for making false claims, including possible treble damages and attorneys’ fees if the litigation ends unfavorably.

Despite the coming onslaught of state and federal regulation and the attendant compliance issues that come with them, it is anticipated that the CBD industry will continue to grow into 2019 and beyond.  Substantial barriers into research and development of new CBD products have now been lifted, as have many barriers on interstate commerce.  Nevertheless, businesses who ship the product throughout the United States should be aware of each state’s laws in which they transact.  Only a handful of states have not yet issued any legislation relating to industrial hemp and its derivatives.  If, for example, one of those states restricts its sale within the state, there could be issues for the producer or seller of such products. Such laws, to the extent that they come to fruition, could be subject to challenge under federal law but could present a headache for the producer or seller.

We here at Norris McLaughlin will continue to keep you apprised of new developments in this regard, so keep checking our Legally Grownblog for more information!  2018 was a great year of change for the cannabis industry but 2019 will surely be even more exciting!  If you have any questions regarding this post or any other related matters, please feel free to email me at [email protected].

Protecting Your Business From Phishing Emails

IS IT A SCAM? IS IT REAL? CAN YOU EVEN SPOT THE DIFFERENCE?

The act of phishing has become an extremely common practice for cyber criminals these days. It’s the number one way that hackers are able to gain confidential information about you. Today, you frequently hear people warning, “if you don’t know who it’s from don’t click or open it!” or “don’t open what I just sent you on Facebook, I was hacked.” These email scams are sneaky but are meant for hackers to get a hold of your sensitive information.

Here are the top 5 most common phishing emails:

“We noticed multiple password attempts, please reset your password” You haven’t attempted to sign into your account, yet you’re receiving an email that you have and that you need to reset your password. They want you to follow these instructions and put in your personal information to change your password, in order to gain access to your account. Delete this email and don’t look back!

“Update your billing information” You receive an email that looks like it’s coming from a well-known company, like Apple for example, requesting you to update your credit card information. Before you click on any link listed or provide any information, check the email address to be sure it’s legitimate.

“We’re giving away $1,000! Click here to receive a reward!” Whatever you do, don’t do it! Nothing in life is free and you never receive a reward for just clicking. There’s always a catch. They will usually ask for bank details, but you will never see any money enter that bank account.

“Someone set you a e-gift card” You must always double check with the sender if you receive an e-gift. Cybercriminals are really good at making things look legitimate. Make sure the emails match and your friend, family member, or colleague can confirm the e-gift.

“Donate today!” This email will usually ask for money to help save a life, help someone who’s terminally ill, or help someone who is a victim of a disaster of some sort. Do not just click on links or attachments or donate without doing your research first. Either go to the official website of a charity you already know, to donate there, or make sure the email address of the sender is authentic.

Protect your business and learn how Guardian can protect your documents and electronic hard drives.

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Transparency and the Avoidance of Corruption: Revisions to New Jersey’s Ban on Gifts From Pharmaceutical Companies

In October 2017, we had a post about a proposed regulation promulgated by the New Jersey Division of Consumer Affairs that would place limitations on payments from pharmaceutical companies to health care providers. The rule did not provide for enforcement or penalties to be assessed against manufacturers, but rather prohibited providers from “accepting” such payments.  The affected licensees were physicians, podiatrists, physician assistants, advanced practice nurses, dentists, and optometrists.  The proposed regulation became effective as of January 16, 2018 and is codified at N.J.A.C. 13:45J-1 et seq. The regulation was one of several initiatives taken by then Attorney General Christopher Porrino to combat the opioid epidemic.  Under the regulation, a New Jersey prescriber may not accept, directly or indirectly, any of the following from a pharmaceutical manufacturer or a manufacturer’s agent:

  • Any financial benefit or benefit-in-kind, including, but not limited to, gifts, payments, stock, stock options, grants, scholarships, subsidies, and charitable contributions, except as specifically permitted by the regulation.
  • Any entertainment or recreational items (e.g., tickets to theater or sporting events, or leisure or vacation trips).
  • Items of value that do not advance disease or treatment education, including, but not limited to:

Pens, note pads, clipboards, mugs, or other items with a company or product logo;

Items intended for the personal benefit of the prescriber or staff, such as floral arrangements, sporting equipment, or artwork;

Any payment in cash or a cash equivalent; or

Any payment or direct subsidy to a non-faculty prescriber to support attendance at, as remuneration for time spent attending, or for the costs of travel, lodging, or other personal expenses associated with attending, any education event or a promotional activity.

  • Any meals unless permitted as described in the regulation with a cap in the amount of $15.

Following Governor Phil Murphy’s election, in the Spring of 2018, the new administration assessed the operation of the rule and its dampening effect on physician participation in continuing education programs. Recognizing the purpose of the regulation as establishing uniform standard to minimize conflicts of interests between health care providers and pharmaceutical manufacturers so that patient care would be guided by the unbiased, best judgment of prescribers, Attorney General Gurbir S. Grewal proposed revisions to the regulation. These appeared in the August 6, 2018 New Jersey Register.  The changes are rather limited. They modify the definition of “modest meal” from a blanket $15 per prescriber to $15 for breakfast and lunch and $30 for dinner during the calendar year 2018 with the amount in future years tied to the consumer price index. Experience with the regulation had shown the absolute $15 limit was “unrealistic.” Another change is to remove the concept of “modest meals” and the limits when associated with educational events even where a manufacturer was the sponsor “provided the meals facilitate the educational program to maximize prescriber learning, including information about disease states and treatment approaches.” Any such meals are not counted in determining the annual cap of $10,000 on payments from pharmaceutical companies for services in connection with presentations as speakers at promotional activities, participation on advisory boards, and consulting arrangements established by the original regulation. The revisions further clarified that the regulation applied only to health care providers with active New Jersey licenses who were involved with patient care in New Jersey and would not apply to an employee of a pharmaceutical company.

The revisions to the New Jersey regulation are being considered when a spotlight is once more on the issue of conflicts of interest among prominent physicians and the pharmaceutical industry. On September 13, 2018, the New York Times reported the resignation of Dr. Jose Baselga, the chief medical officer of Memorial Sloan Kettering Cancer Center, for failure to disclose millions of dollars he had received from drug companies while publishing articles about these products in medical journals. The article included a comment that “Ethicists say that outside relationships with companies can shape the way studies are designed and medications are prescribed to patients, allowing bias to influence medical practice.  Reporting those ties allows the public, other scientists and doctors to evaluate their research and weigh potential conflicts.”

The same issue of the New York Times contained an Op-Ed piece by Marcia Angell, M.D. entitled “Transparency Hasn’t Stopped Drug Companies From Corrupting Medical Research.”  Dr. Angell had been the editor of the New England Journal of Medicine for over 20 years and was at the NEJM in 1984 when it became the first major journal to require authors to disclose financial ties to companies that could be affected by the publication of their research.  In her Times piece, Dr. Angell reviewed the reasons that manufacturers became financially involved with medical researchers and how financial ties could bias the work.  She concluded with these comments:

Disclosure is better than no disclosure, but it does not eliminate the conflict of interest. It’s simply a way of saying caveat emptor, and leaving it to readers to decide whether the research was biased.  But most people – even doctors and science reporters – aren’t really equipped to make those judgments, particularly when data are suppressed.

I would suggest two reforms. First, researchers at academic medical centers should not accept any payments other than research support from drug companies, and that support should have no strings attached – no control over the design, interpretation and publication of trial results.  We should go back to arm’s length grants.

Second, doctors should not accept gifts from drug companies, even small ones, and they should pay for their own meetings and continuing education, as is standard in other professions. They can afford it.

In the meantime, those of us who read these studies should remain skeptical about them until several different trials reach the same result.

These controversies have been present for a long time with various measures taken to protect patients and keep physicians focused on patient care. Some of that history was reviewed in an earlier blog post from 2014 with the commencement of the Obamacare Physician Payment Sunshine Act which encompasses more than research physicians.  In 2016, New Jersey ranked 11th in the nation for the most non-research payments to health care professionals based on the Open Payments data.[1]

The New Jersey Board of Medical Examiners has brought disciplinary proceedings against physicians for failure to make disclosures of payments received from medical product manufacturers. It has recently continued to bring disciplinary actions based on violation of its kickback rule, N.J.A.C. 13:35-6.17(c)(1), prohibiting licensees from receiving any form of compensation that “a reasonable person would recognize as having been given” to promote the prescribing of a product for patient use.[2]

The efforts of the New Jersey Attorney General to study and explore appropriate ways to deal with these conflicts of interests issues can be traced back to at least 2007 and such efforts are obviously continuing. This may be like the sound of one hand clapping or at least a voice crying in the wilderness.  But it should be noted that the Hippocratic Oath – dating back to the Fourth or Fifth Century B.C. and still administered to modern day physicians – includes a provision that “into whatever homes I go, I will enter them for the benefit of the sick, avoiding any voluntary act of impropriety or corruption.”

[1]  Helman, Farrar, Horton, Segobiano & Dingler, Physician, Feed Thyself: New Jersey’s Restriction On Pharmaceutical Payments (Jan. 24, 2018) available at https://www.navigant.com/insights/life-sciences-consulting/2018/new-jerseys-restriction-on-pharmaceutical-payments

[2]   See, e.g., In the Matter of Kenneth Sun, M.D. (Aug. 27, 2018)(between 2013 and 2015 more than $117,000 in payments) available at  https://www.njconsumeraffairs.gov/Actions/20180827_25MA06318400.pdf.