Category Archives: Business

What Qualifies as Extra Label Drug Use

Q: How do I know what qualifies as ELDU?

A: Specific criteria must be followed:

  • A valid VCPR is a prerequisite for all ELDU;
  • Only a veterinarian can determine that ELDU is needed and can administer, prescribe or dispense a medication extralabelly. The veterinarian must direct or supervise ELDU in an animal;
  • ELDU rules only apply to FDA-approved animal and human drugs;
  • ELDU is intended for prevention, treatment, and control purposes only when an animal’s health is threatened. ELDU of drugs for production use and/or in feed is not approved;
  • ELDU is not permitted if it results in an illegal food residue, or any residue which may present a risk to public health;
  • A veterinarian must not pursue use of certain FDA-prohibited drugs in food-producing animals.

ELDU of an FDA approved drug may be used if:

  • There is no approved animal drug that is labeled for such use, or that contains the same active ingredient in the required dosage form and concentration.
  • Alternatively, an approved animal drug for that species and condition exists, but a veterinarian finds, within the context of a VCPR, that the approved drug is clinically ineffective for its labeled use.

There are few restrictions on extralabel use in non-food-producing animals compared to food-producing animals. If the intended use is in a non-food-producing animal, then an approved human drug may be considered for extralabel use even when an approved animal drug for that species and condition exists. Economic reasons for ELDU of a human drug over the approved drug for that species are valid to treat the medical condition. Veterinarians should recognize, however, that human-labeled drugs are approved based on studies in people and their use in animals could vary. In addition, minor differences in the formulation may produce alterations in the pharmacokinetics and biological availability in the animal species compared to humans. Also keep in mind that consistent use of human-labeled drugs when approved animal-labeled drugs are available could create relative disincentives for the animal health industry to pursue new animal drug approvals and could further limit the availability of veterinary drugs.

The following additional conditions must be met for ELDU in food-producing animals:

  • Such use must be accomplished in accordance with an appropriate medical rationale; and
  • If scientific information on the human food safety aspect of the use of the drug in food producing animals is not available, the veterinarian must take appropriate measures to assure that the animal and its food products will not enter the human food supply.

If the veterinarian determines the food-producing animal needs a drug administered in an extralabel fashion, an approved animal drug must be considered for the particular use before a drug labeled for humans is considered. The prescribed or dispensed extralabel drug (prescription legend or over-the-counter) must bear labeling information which is adequate to assure the safe and proper use of the product.

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Labor Law Update for Dentists

As of April 30, 2012, most private sector employers will be required to post a notice advising employees of their rights under the National Labor Relations Act. This requirement applies to a variety of entities with a gross annual volume of at least $250,000.00. The poster is available for free at https://www.nlrb.gov/poster or by calling (202) 273-0064.

In addition to the NLRA poster, the U.S. government requires the posting of these workplace posters: 1) Employee Polygraph Protection, 2) Equal Employment Opportunity, 3) Fair Labor Standards Act, 4) Job Safety and Health Protection, 5) Rights Under the Family and Medical Leave Act (for employers of 50 or more individuals), and 6) Uniformed Services Employment and Reemployment Rights Act. You can obtain them for free from the U.S. Department of Labor Web site www.dol.gov/compliance/topics/oster.htm.

Should you choose a friend to be your business partner?

Planning to start a business partnership with a friend? Prudence demands looking at the pitfalls – as well as the potential strengths – of such relationships. Here are a few questions to consider.

What will my friend contribute to the business? Does he or she have strengths that will clearly enhance the business – abilities, knowledge, or resources that you don’t possess or aren’t willing to acquire by other means? Say, for example, you are good with customer relations, but not too good with numbers. If your friend loves details and is clever with records, the partnership may make sense. If, on the other hand, your friend really can not offer something that would round out the business or make it more profitable, you might want to consider partnering with someone else.

Are you willing to lose the friendship? This is a tough question, but one that’s critical to consider. After all, you and your friend will be working together, day in and day out, to make the business succeed. Such relationships can bring out the best – and worst – in people. If maintaining your friendship is one of your highest priorities, partnering with someone else may be a better choice.

What’s expected from each partner? Developing a profitable business is hard and often unrewarding work. You and any potential business partner should honestly discuss expected work hours, contributions, and responsibilities. Resentment can creep into any business relationship when partners feel that workloads and rewards aren’t fairly distributed.

Can you communicate effectively? Like a good marriage, a long-term business partnership takes honest communication to succeed. Ask yourself, for example, whether you can handle constructive criticism from your friend/business partner. Even the closest business partners don’t always see eye to eye, so it’s important to take an honest look at how you both handle disagreements. Will you work through difficulties for the firm’s sake, or bury your head in the sand and hope for the best? Answering this question is crucial to the success of your partnership.

Protecting the Value of Your Practice:
 Non-Compete and Trade Secret Agreements

Practice owners are often concerned about how to best protect their patient base when an associate leaves the practice. There are two methods of preventing this type of devastation to a practice, which are: (1) non-compete agreements and (2) trade secret agreements.  Both of these types of agreements should be incorporated into an associate’s employment agreement.
Non-Compete Agreements
A non-compete agreement allows the owner of a practice to limit a former associate from starting his or her own practice as well as prohibit an associate from working for a competitor.  The owner of a practice should always consult with their attorney before entering into any type of non-compete agreement.
Trade Secrets
A trade secrets provision in an associate’s employment contract will also help protect confidential information of a practice.  A trade secrets provision should provide that all patients and their confidential information are trade secrets of the practice, and sanctions will be enforced against any associate or employee who attempts to use this confidential information for their own personal gain.
The owners of a practice must be familiar with non-compete and trade secrets agreements.  All associates should be required to sign a non-compete and a trade secrets agreement at the beginning of their employment.
Without a proper non-compete and trade secrets agreement, either prepared separately or incorporated into an associate’s contract, the owner of a practice has substantial financial risk.

Five Potential Legal Risks Associated with Groupon

With the explosion of social media and online marketing, members of the dental community “must” be aware of the risks associated with the new marketing. While dental practices have successfully utilized the services of Groupon to attract new patients, there are growing concerns regarding this type of marketing. The American Dental Association has recently published its opinion on the Groupon issue. Before a dentist participates in a Groupon marketing campaign, they must be aware of potential ramifications.

1: Fee-Splitting
A dentist utilizing Groupon to offer discounts to new and current patients will split a portion of the revenue generated from the promotion with Groupon. Many states have regulations that prohibit fee splitting between a dentist and a third party. A violation of the state regulations could result in the dentist facing censure and reprimand, fines, suspension, and even license revocation.

2: Federal Anti-Kickback Statute
The federal anti-kickback statute, 42 U.S.C. § 1320a-7b(b) generally prohibits a dentist from offering or paying remuneration to induce a person to refer a patient that may be eligible for services under a federal health care program, including Medicare or Medicaid. A dentist violating federal law could be charged with a felony and subject to fines, imprisonment, and exclusion from federal health care programs.

3: Most Favored Nations Clause
The terms of a dentist’s contract with third party payors [insurance carriers] may pose problems with the offer and award of Groupon’s discounts to patients. Many insurance contracts provide that the dentist must provide the insurer with the best price that the dentist charges for a particular service (a “most favored nations” clause). Providing a discounted rate to Groupon customers may breach the most favored nation provision in an insurance contract. As a result, the dentist may be required to offer the same discount to the insurer’s patients.

4: ADA Ethical Rules
According to the American Dental Association Principles of Ethics and Code of Professional Conduct Section 4.E. Rebates and Split Fees, dentists “shall not accept or tender ‘rebates’ or ‘split fees’”.

5: Dental Boards
Most dental boards provide that a dentist “shall not give rebates or split fees with a referral source”.

Before a dentist enters in to or starts any type of marketing campaign (or social media campaign), they should seek legal advice as to the application of state and federal laws, the most favored nations clause, ADA Ethical rules and Dental Board rules. While the marketing of any dental practice is important, an ill-advised marketing campaign could result in a dentist being censured, reprimanded, fined, suspended, and lose their license.

Oral Cancer: Risk Management Considerations

Due to the increasing public concern regarding oral cancer, it is important for dentists to be aware of proper patient assessment and documentation procedures so that they may provide timely and proper treatment to their patients.

The U.S. Department of Health and Human Services states that oral pharyngeal cancers affect around 30,000 people per year in the United States, with around 8,000 of those cases resulting in death. A good deal of malpractice claims against dentists in the United States involve oral cancer cases.

For every dental practice, correct patient assessment is the first step in minimizing any risk to future legal entanglements. When assessing a patient and planning a treatment strategy, dentists should first carefully review the patient’s medical history to note any predisposing oral cancer factors. Next, a comprehensive oral evaluation should be completed.

This full examination should be followed with a review of oral radiographic images in order to note any potential abnormalities in the bones and dentition of the patient.

Properly documenting the patient assessment is just as important as accurately assessing the patient. In order to satisfy the basic standard of care, all dentists are required to perform these evaluations and note all the results from the examination in the patient’s permanent record.

In cancer cases, it is crucial that a treating dentist contact the patient’s oncologist to determine if any special precautions should be taken for the patient before and after undergoing medical treatment, such as chemotherapy. It is also essential that the medical history dictated in the patient’s record include information regarding whether or not the patient has undergone such medical treatment.

Dentists must carefully follow all procedures in the practice in order to help them avoid legal pitfalls. Properly assessing and examining the patient and documenting the patient’s record will not only keep the dentist out of legal trouble, but it will also provide the patient with positive dental care service.

9 Areas of a Practical Employee Office Manual

In the last few weeks, we have received more and more questions as to what additional provisions should be included in an Employee Manual, over and above the “standard” provisions. As a result, outlined below are nine provisions which should be included in every Employee Manual.

1 Employee Recruitment: This provision should include where to advertise for employees, how to write job advertisements, how to prepare effective job descriptions, proper interview techniques, as well as sample interview questions.

2 Office Policies: This provision should focus on establishing office policies and procedures in order to introduce new staff to your practice, as well as provide ground-rules and practice philosophy.

3 Employment Policies: With this provision, you should establish guidelines for personal appearance, sexual harassment, and substance abuse. In addition, an employee manual should also outline the use of cell phones and social media within the practice and outside of the practice.

4 Employee Training: Your office manual should establish employee training techniques from OSHA and HIPAA, where mandatory.

5 Employee Benefits: Every employee manual should address vacation, sick time, other leave policies, health insurance coverage, and retirement plans.

6 Employee Management: This provision should set forth employee management guidelines in order to promote positive office morale, employee appreciation and incentive programs, bonuses, performance-based raises, and performance evaluations.

7 Employee Termination: This provision should focus on the delicate but important issue of employee termination procedures. Failure to address employee termination in the proper manner could open a practice owner up to certain violations of state and federal law.

8 Employee Management: This provision should set forth guidelines for employees to promote positive relations with special needs, pediatric, geriatric, and difficult patients through confident communication skills.

9 Workplace Safety and Security: Your office manual should examine safety and security in the workplace, including complying with OSHA standards, as well as handling emergencies and natural disasters.

These nine categories form the foundation of any great employee manual. By evaluating your Employee Manual and implementing a few additional provisions, a practice owner may avoid a wide range of employment law problems.