Dear Doctor/Patient,

As you are probably aware, there have been recent reports of unsafe levels of lead in restorations outsourced to China leading to adverse reactions in some patients.

Being a certified registered member of the National Association of Dental Laboratories (NADL) and being in business for more than 25 years we can assure you and your patients that all of our restorations are domestically made. We use only FDA and ADA approved materials. We identify these products with Identalloy and IdentCeram stickers with every restoration for patient records.

With the amount of work now being outsourced to other countries we feel these concerns will be a continuing issue in the future. Van Hook Dental Studio guarantees that you will never encounter this problem with our restorations.

Thank you for your business and please feel free to contact us if you have any questions.

Sincerely, 

Don Van Hook
President Van Hook Dental Studio
Member, American Academy of Cosmetic Dentistry and AACD

HIPAA Dental Laboratory Compliance

The Privacy Rule of the Health Insurance Portability and Accountability Act of 1996 (hereafter referred to as HIPAA) does not require a Business Associate Agreement for "Laboratory Services" when "the service rendered is treatment only and does not include other administrative services...".(1) An Associate Agreement, would however, be required in situations where "the lab is electronically transmitting claims to health insurers.(2) This exemption has been construed to include services traditionally provided by a dental laboratory pursuant to a prescription provided by a dental practitioner. The U.S. Department of Health and Human Services drafted the Privacy Rule so as to limit interference with the sharing of information among health care providers for the treatment of patients.(3) The Privacy Rule classifies dentists and the dental laboratories they engage for the production of dental prosthetics as health care providers.(4) Disclosures between dental providers and dental laboratories related to treatment activities are explicitly exempted from the Business Associate requirements of the Privacy Rule.(5)

Further support for this position is provided by the Office of Civil Rights (OCR), a sub agency within the Department of Health and Human Services (DHHS) charged with HIPAA Privacy Rule enforcement provisions, when it stated that "it [OCR] agrees . . . that dental laboratories are health care providers, so no Business Associate Agreement is required to share protected health information for treatment purposes”.(6) It is important to note that the information provided to dental laboratories by dental providers is limited, in most cases, to a first and last name which the lab uses to identify individual prescriptions provided by the dental provider. Should the dental provider prefer, an in office coding system can be substituted in place of the patient's first and last name, with the understanding that such a code will uniquely identify that patient within the dental provider's information system. The lab does not receive patients’ telephone numbers, addresses, social security numbers, medical records or data directly identifying individuals, relatives, employers, household members or other information identified by the Privacy Rule as constituting Protected Health Information (PHI).

Examples of transactions covered by HIPAA regulations can be found in the March 17, 2003 issue of the ADA News under the title of “Final HIPAA Electronic Health Care Transaction Standards Announced,” located on page 15. Additionally, you can call the ADA’s HIPAA Hotline at (312) 440-2899, ext. 3, for a recorded message detailing the exempted status of dental laboratories and what transactions fall within this exemption. Although a business associate agreement is not required, Van Hook Dental Studio remains committed to safeguarding the confidentiality of our clients and has expended considerable resources in the protection and proper handling of all information. We appreciate the opportunity to serve you and your patients and thank you for making Van Hook Dental Studio your dental laboratory of choice.

References

1. See Guidance for Identifying Business Associates 32102
2. (Western States News, “Dental Labs as Health Care Providers”, April, 2003, Page 8)
3. See 67 Federal Register 53252
4. See 65 Federal Register 82568
5. See Privacy Rule 164.502 (e)(1)
6. (ADA News, “ADA, NADL, OCR Agree on Status of Labs”, May 5, 2003, Page 6)