Compliance Issues For Medical Specialties

At Cohen Healthcare Law Group, PC, we represent a variety of healthcare practices including specialty practices such as dentistry, veterinary practices, and speech pathology. We advise these practices on a broad range of regulatory and transactional issues. Many of the issues we advise these clients about are similar to the issues we advise all healthcare practices, allied healthcare practices, behavioral practices, and other medical group practices. The issues are also comparable to the issues other core clients including ASCs, integrative practices, diagnostic practices, and other medical practices have.

There are also issues which are unique to the specialties or are more common to the specialties. For example, more and more specialties are trying to incorporate telemedicine into healthcare specialties.

We represent many different specialty practices including the following:

Dental Practice

According to the American Association of Oral and Maxillofacial Surgeons, dentistry is defined as:

 “the evaluation, diagnosis, prevention and/or treatment (nonsurgical, surgical or related procedures) of diseases, disorders and/or conditions of the oral cavity, maxillofacial area and/or the adjacent and associated structures and their impact on the human body; provided by a dentist, within the scope of his/her education, training and experience, in accordance with the ethics of the profession and applicable law.”

There are many different regulations that govern the business/financial side of dentistry and other regulations that affect the everyday practice of dentistry. Common dentistry/common medical practice compliance issues involve:

• HIPAA privacy and security compliance.
• Stark Law, AKS, and fee-splitting laws. This includes leasing or buying office space and office equipment.
• The corporate practice of medicine.
• Licensing and unauthorized practice of medicine issues. Dentists need to set proper standards for which dental tasks they can assign to others in the office and which ones they must perform themselves.
• Advertising and marketing are subject to FTC compliance and other federal and state laws and regulations. All online and offline promotions must be honest. Deceptive promotional practices and communications may be subject to legal action.
• Business formation, business operation, and business contract issues.

Some of the issues that dentists and oral surgeons must also review with experienced healthcare lawyers include:

• Infection control. The Occupational Safety Health Administration (OSHA) and the Centers for Disease Control and Prevention (CDC) both regulate the dentistry profession regarding workplace safety standards and how best to control infections.
• Telemedicine. In large measure, telemedicine is not too practical for the dental profession because dentistry does require extensive hands-on care. Dentists are generally permitted to use telehealth to schedule appointments, to answer questions from patients, and for other informational purposes.

Veterinarians

According to Science Daily, veterinary medicine is:

“the application of medical, diagnostic, and therapeutic principles to companion, domestic, exotic, wildlife, and production animals.” “It requires the acquisition and application of scientific knowledge in multiple disciplines and uses technical skills towards disease prevention in both domestic and wild animals.” Among other issues, veterinarians are accountable for FDA compliance and must meet a variety of federal and state business standards…”

Many of the same compliance issues that apply to physicians and healthcare practices that treat humans also apply to veterinarian practices. Veterinary practices need to review the following regulatory issues with an experienced healthcare lawyer:

• Anti-fraud laws such as Stark Law and the Anti-Kickback Statute (AKS)
• Confidentiality of veterinary patient records. While HIPAA generally applies to people (animals are generally considered property and not people), many states do have laws governing the confidentiality of veterinary patient records. California, for example:
  • Generally requires client consent to record disclosures unless there is a court order or the issue of a veterinarian’s care is at issue in a court case. “Sharing medical information between veterinarians or facilities is allowed for treatment or diagnosis” Generally, the animal records should be made promptly available to the pet owner on request.
• Marketing and advertising. The FTC and other agencies may regulate the online and offline promotions for honesty and to ensure the pet owners are not being deceived.
• Licensing requirements.
• Various transactional issues involving the operation of the veterinary practice.

Two compliance issues that are fairly unique to veterinary practices are telemedicine and FDA compliance.

• Telemedicine. Veterinarians who diagnose and treat family pets, livestock, and any other animal categories generally must:
  • Provide the same standard of medical care as they would for in-office visits
  • Must keep records in the same way they would for in-patient visits
  • Are generally required to be licensed in either the state where the vet doctor is located, where the animal is, or both.

The American Veterinary Medical Association generally requires that “veterinary telemedicine should only be conducted within an existing Veterinarian-Client-Patient Relationship (VCPR), with the exception for advice given in an emergency until that patient can be seen by a veterinarian.” “Eligibility to provide veterinary medical advice by telemedicine should be limited to those who are also legally authorized to practice veterinary medicine in that state.” The models of care will vary depending on the type and breed of animal. A skilled healthcare lawyer will review and explain the legal issues involving the practice of veterinary telemedicine.

• FDA oversight. FDA’s Center for Veterinary Medicine works to ensure that animal food is safe, sanitary, and properly labeled. The Center also monitors animal drugs, animal food additives, and animal devices for safety and effectiveness. FDA oversight includes sending warning letters, conducting inspections, issuing recalls, refusing imports, seizing products, seeking injunctions, and other legal actions. Veterinarians need to be aware of these compliance issues when the recommend and use these products.

Speech Therapists (SLPs) and other types of therapists

SLPSs work with people of every age to treat communication and swallowing problems including:

• Problems of articulation, phonology, speech apraxia, or dysarthria
• How well patients hear, read and use words
• Literacy
• The ability to communicate with others
• Voice issues
• Stuttering and other speech flow issues
• How well the patient’s memory, attention, and other cognitive communication skills work
• Swallowing chewing, and feeding issues

Additional types of therapists that need to review regulatory compliance issues with skilled healthcare attorneys include:

• Physical therapists. Physical therapy is generally used for pain management; for mothers after birth, and to recovers from injuries or surgeries. Patients may need to learn to use medical devices such as canes, walkers, and wheelchairs. Patients learn to cope with chronic illnesses.
• Occupational therapists. These therapists help people who require specialized assistance to participate in everyday activities, or “occupations.” The patients include people who need help so they can work – and also so they can do everyday chores and engage in recreational activities. Occupational therapists help people with many simple tasks such as eating and dressing. They help:
  • Children with physical disabilities
  • Adults who suffer from depression
  • Seniors with physical limitations
  • Many other patients

Speech therapists, physical therapists, occupational therapists and other therapists (such as vocational therapists) must generally:

• Obtain the informed consent of the patients
• Comply with HIPAA and state privacy and confidentiality laws
• Understand the issues about the unauthorized practice of medicine
• Understand what types of medical oversight and administration the physicians must meet and what licensing requirements for staff are required
• What intake forms are required
• The issues involved with treating Medicare and Medicaid patients
• Co-ownership with other health provider issues
• Scope of practice issues

Additional compliance issues depend on whether the therapy being offered is at an outpatient or an inpatient facility.

Chiropractors

“Becoming a doctor of chiropractic (DC) requires a minimum of 2 years of college and 4 years in a school of chiropractic medicine. Some chiropractors also earn a traditional medical degree (MD) or other additional qualifications. Not all chiropractors are alike in their practice. The International Chiropractors Association believes that patients should be treated by spinal manipulation alone, whereas the American Chiropractic Association advocates a multidisciplinary approach that combines spinal adjustment with other modalities, such as physical therapy, psychological counseling, and dietary measures.”

Some of the unique legal issues skilled healthcare compliance lawyers review for chiropractors are:

• Fee-splitting arrangements with other physicians such as pain management doctors
• Can chiropractors legally practice functional medicine?

Chiropractors must also comply with HIPAA, corporate practice of medicine issues, unauthorized practice of medicine issues, and many other laws and regulations.

Issues that apply to most, if not all, specialties

Generally, all medical specialties need to review the following compliance and transactional issues with an experienced healthcare lawyer:

• Regulations and compliance. We advise specialty practices about:
  • Stark Law, the Anti-Kickback Statute (AKS), and fee splitting laws
  • The Health Insurance Portability and Accountability Act of
  • When and how to use a Managed Service Organization (MSO) for the administrative functions of a medical practice
  • Warning letter, injunctions, and other enforcement actions by:
    • The Federal Trade Commission (FTC). This agency generally monitors your advertising and marketing to ensure you’re not making false and misleading claims in your online and offline promotions and communications.
    • Food and Drug Administration (FDA) monitoring of the medical devices specialties uses and the drugs they prescribe. FDA oversight also applies to other healthcare products that affect patient safety. Specialists need to understand that FDA inspections will review online and offline promotions and may inspect an office to determine if the medical practice isn’t making unsubstantiated claims (misbranded claims) or claims that may indicate the treatments are unapproved drugs.
    • Over-the-Counter (OTC) compliance
    • Licensing and unauthorized practice of medicine issues
• Skilled healthcare lawyers also advise specialists about a broad range of business and transactional issues such as:
  • Professional medical corporation formation and other types of permissible business structures
  • Employment and staffing contracts
  • E-commerce issues
  • Real estate and licensing
  • How business disputes are resolved
  • Insurance issues

Medical specialties need to comply with a broad range of federal and state laws, rules, and regulations. An experienced healthcare lawyer can explain which laws such as HIPAA, Stark Law, and the AK apply to your practice. We’ll help review your online and offline marketing and any FDA warning letters. We’ll help explain how telemedicine affects your practice.

Medical practice specialties should contact Cohen Healthcare Law Group, PC for legal advice on compliance and business issues. Our experienced healthcare attorneys FTC and FDA healthcare lawyers represent dentists, veterinarians, chiropractors, therapists, and other medical specialties.