Regulatory Issues Can Create Legal Liability

November 12, 2018

There are many regulatory agencies that have a role in overseeing a plastic surgery practice. The HIPAA privacy scheme protects patient privacy and medical information. As a matter of good practice, you should have the patient sign an acknowledgment that they have received a copy of their privacy rights. “Red flag rules” obligate your practice to guard against identify theft by, among other things, gathering each patient’s identity and connecting it to a medical record. Common practices include a photo ID with the insurance card, and ensuring that the patient’s medical record matches their care and treatment. 


Within your practice, the Occupational Safety and Health Administration (OSHA) covers equipment, office supplies and working conditions to ensure safety in the workplace. All supplies should be labeled with appropriate precautions marked, as well as a log of emergency treatment, should an accident occur.


The FDA controls manufacturers of devices and products and although the FDA does not directly oversee physicians, it imposes requirements for off-label use of medications and devices. Off-label use involves the nonexperimental use of an FDA-approved device or product in a nonapproved fashion. Any such use should include the patient’s consent and acknowledgment of the off-label use of the medication or product. Your office should be careful to purchase only FDA-approved supplies; though online suppliers may offer big discounts on foreign made products, such products are most often not FDA approved. Using such products would be illegal, and could make the purchaser and practice subject to civil and criminal charges. 


State medical boards as well as state nursing and other regulatory agencies outline appropriate care in the office. State medical boards describe which providers can perform services in an office environment and with what degree of supervision. It is critically important for all staff in the practice to understand and comply with these rules. Certain procedures can only be performed under the physician’s direct supervision; administering those procedures (like Botox injections or laser treatments) while the physician is out of the office is a dangerous practice. Any injury suffered by a patient under such circumstances will trigger a medical board investigation and potential disciplinary action.


Additionally, such conduct may void your malpractice coverage, and will impact your defense of the legal action.  For obvious reasons, it is important to stay abreast of amended guidelines or standards in order to remain in compliance with regulatory requirements. If your office is not in compliance with regulatory guidelines, you are opening yourself up to legal liability in a negligence action, should the failure to implement the new guidelines be even remotely related to the alleged injury. 


One regulatory issue that is not immediately obvious to physicians is pricing. You are free to set your own prices for the procedures you perform. You are also able to determine your pricing based on other health care provider’s marketing materials. However, it is a possible violation of antitrust laws to discuss fees and pricing with a competitor, particularly in a small market or where your practice and the competitor dominate the market. 


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