Federal Regulatory Issues


The Health Insurance Portability and Accountability Act of 1996 (HIPAA) enacted various privacy and security protections related to patient health information. Individuals, organizations and agencies that meet the definition of a "covered entity" must comply with HIPAA. The majority of health care providers, including optometrists, are required to comply with HIPAA.

An optometrist is considered a "covered entity" if he/she transmits any information in an electronic form in connection with a transaction for which the Department of Health and Human Services (HHS) has adopted a standard. For example, submitting an electronic claim to Medicare or another payer is such a transaction. HHS has a tool for determining if you are a covered entity available here.
Since HIPAA became law, there have been a number of regulations issued that govern how health care providers must protect the privacy of the patients they treat. Updated HIPAA regulations were issued in January 2013, the majority having a compliance deadline of September 23, 2013.

AOA has developed materials relating to HIPAA compliance, including a sample business associate agreement. These materials may be used by optometrists in Pennsylvania without the need for modification.

HIPAA Resources from AOA are available at:



Contact Lens Patient Protection

The Fairness to Contact Lens Consumers Act (FCLCA) became law on February 4, 2004. The Act mandates that eye care practitioners, including optometrists, release contact lens prescriptions to their patients. It also requires contact lens sellers to verify the validity of contact lens prescriptions before releasing contact lenses to consumers.

Resources from AOA

Complaints and violations should be filed with the FTC, and reports of patients who have been harmed or injured due to the illegal sale of contact lenses should submitted to the FDA. Copies of filings with the FTC and FDA should be e-mailed to AOA at FTCcomplaint@aoa.org.

Misuse of DEA Numbers

AOA and POA have developed a form for doctors to use to report DEA misuse. Please send this completed form to POA, and we will send compiled information to AOA.

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