The proposed rule required the physician to get a signed contract from the business associate that explicitly laid out procedures for handling sensitive patient information. That provision stays in the final rule. The final rule eases that standard. A third touchy area was the operation of disease management programs, about which the proposed rule was unclear. For example, it was not clear that a physician could contact patients and alert them to disease management or health promotion programs being initiated by pharmaceutical manufacturers or pharmacies.
Physicians can send patients pretty much the same information in either case.
But if they are getting compensation, they must disclose that in the marketing communication and also include a number of other disclosures, including how patients can prevent future such missives from reaching them. Often, based on that small sample of bills, the OIG finds an overpayment and extrapolates that overpayment to the physician's entire Medicare income pool. In H.R. 5661, however, Congress only asked the U.S. General Accounting Office to do a study on this issue. Again, all Congress did was ask the Medicare Payment Advisory Committee to make recommendations. H.R. 5661 did slightly expand Medicare benefits.