Laboratory Client Billing Regulations
Generally direct billing patients for laboratory services is not a problem. Most DPC practices have negotiated low rates with national laboratories and these low rates are commonly arranged with the expectation that the lab collects its fee from the DPC practice rather than the patient. The DPC practice then seeks payment from the patient. We are aware that this relationship is apparently either difficult or not possible in New York and New Jersey, but other states do not appear to have a concern with this arrangement. Pathology direct billing laws are different.
In twenty states it is possible for patients to obtain tests on their own without an order from any physician (as discussed in this ASCP policy handout) and labs are permitted to provide test results directly to the patient even when ordered by the physician.
Here is a link to an OIG report where the Dept of HHS has expressed their concerns about physician practices being billed by the laboratory and then turning around to seek payment from patients. (One more reason it is wise for DPC physicians to "opt out" of Medicare.)
This detailed review by Mr. Gary discusses AMA Code of Ethics, along with federal and state issues surrounding client billing (using Tennessee as a state example).